[House Report 117-364]
[From the U.S. Government Publishing Office]
117th Congress } { Rept. 117-364
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
_______________________________________________________________________
RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING ACT OF 2022
----------
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
To accompany H.R. 7666
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
June 13, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING ACT OF 2022
117th Congress } { Rept. 117-364
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
_______________________________________________________________________
RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING ACT OF 2022
__________
R E P O R T
of the
COMMITTEE ON ENERGY AND COMMERCE
To accompany H.R. 7666
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
June 13, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
__________
U.S. GOVERNMENT PUBLISHING OFFICE
47-779 WASHINGTON : 2022
117th Congress } {Rept. 117-364
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING ACT OF 2022
_______
June 13, 2022.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 7666]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 7666) to amend the Public Health Service Act to
reauthorize certain programs relating to mental health and
substance use disorders, and for other purposes, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary............................................42
II. Background and Need for the Legislation........................43
III. Committee Hearings.............................................49
IV. Committee Consideration........................................49
V. Committee Votes................................................50
VI. Oversight Findings.............................................56
VII. New Budget Authority, Entitlement Authority, and Tax Expenditur56
VIII. Federal Mandates Statement.....................................56
IX. Statement of General Performance Goals and Objectives..........56
X. Duplication of Federal Programs................................56
XI. Committee Cost Estimate........................................56
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits....56
XIII. Advisory Committee Statement...................................57
XIV. Applicability to Legislative Branch............................57
XV. Section-by-Section Analysis of the Legislation.................57
XVI. Changes in Existing Law Made by the Bill, as Reported..........66
XVII. Communications from Other Committees..........................456
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Restoring Hope for
Mental Health and Well-Being Act of 2022''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--MENTAL HEALTH AND CRISIS CARE NEEDS
Subtitle A--Crisis Care Services and 9-8-8 Implementation
Sec. 101. Behavioral Health Crisis Coordinating Office.
Sec. 102. Crisis response continuum of care.
Subtitle B--Into the Light for Maternal Mental Health and Substance Use
Disorders
Sec. 111. Screening and treatment for maternal mental health and
substance use disorders.
Sec. 112. Maternal mental health hotline.
Sec. 113. Task force on maternal mental health.
Subtitle C--Reaching Improved Mental Health Outcomes for Patients
Sec. 121. Innovation for mental health.
Sec. 122. Crisis care coordination.
Sec. 123. Treatment of serious mental illness.
Subtitle D--Anna Westin Legacy
Sec. 131. Maintaining education and training on eating disorders.
Subtitle E--Community Mental Health Services Block Grant
Reauthorization
Sec. 141. Reauthorization of block grants for community mental health
services.
Subtitle F--Peer-Supported Mental Health Services
Sec. 151. Peer-supported mental health services.
TITLE II--SUBSTANCE USE DISORDER PREVENTION, TREATMENT, AND RECOVERY
SERVICES
Subtitle A--Native Behavioral Health Access Improvement
Sec. 201. Behavioral health and substance use disorder services for
Native Americans.
Subtitle B--Summer Barrow Prevention, Treatment, and Recovery
Sec. 211. Grants for the benefit of homeless individuals.
Sec. 212. Priority substance abuse treatment needs of regional and
national significance.
Sec. 213. Evidence-based prescription opioid and heroin treatment and
interventions demonstration.
Sec. 214. Priority substance use disorder prevention needs of regional
and national significance.
Sec. 215. Sober Truth on Preventing (STOP) Underage Drinking
Reauthorization.
Sec. 216. Grants for jail diversion programs.
Sec. 217. Formula grants to States.
Sec. 218. Projects for Assistance in Transition From Homelessness.
Sec. 219. Grants for reducing overdose deaths.
Sec. 220. Opioid overdose reversal medication access and education
grant programs.
Sec. 221. State demonstration grants for comprehensive opioid abuse
response.
Sec. 222. Emergency department alternatives to opioids.
Subtitle C--Excellence in Recovery Housing
Sec. 231. Clarifying the role of SAMHSA in promoting the availability
of high-quality recovery housing.
Sec. 232. Developing guidelines for States to promote the availability
of high-quality recovery housing.
Sec. 233. Coordination of Federal activities to promote the
availability of recovery housing.
Sec. 234. NAS study and report.
Sec. 235. Grants for States to promote the availability of recovery
housing and services.
Sec. 236. Funding.
Sec. 237. Technical correction.
Subtitle D--Substance Use Prevention, Treatment, and Recovery Services
Block Grant
Sec. 241. Eliminating stigmatizing language relating to substance use.
Sec. 242. Authorized activities.
Sec. 243. Requirements relating to certain infectious diseases and
human immunodeficiency virus.
Sec. 244. State plan requirements.
Sec. 245. Updating certain language relating to Tribes.
Sec. 246. Block grants for substance use prevention, treatment, and
recovery services.
Sec. 247. Requirement of reports and audits by States.
Sec. 248. Study on assessment for use in distribution of limited State
resources.
Subtitle E--Timely Treatment for Opioid Use Disorder
Sec. 251. Study on exemptions for treatment of opioid use disorder
through opioid treatment programs during the COVID-19 public health
emergency.
Sec. 252. Changes to Federal opioid treatment standards.
Subtitle F--Additional Provisions Relating to Addiction Treatment
Sec. 261. Prohibition.
Sec. 262. Eliminating additional requirements for dispensing narcotic
drugs in schedule III, IV, and V for maintenance or detoxification
treatment.
Sec. 263. Requiring prescribers of controlled substances to complete
training.
TITLE III--ACCESS TO MENTAL HEALTH CARE AND COVERAGE
Subtitle A--Collaborate in an Orderly and Cohesive Manner
Sec. 301. Increasing uptake of the collaborative care model.
Subtitle B--Helping Enable Access to Lifesaving Services
Sec. 311. Reauthorization and provision of certain programs to
strengthen the health care workforce.
Subtitle C--Eliminating the Opt-Out for Nonfederal Governmental Health
Plans
Sec. 321. Eliminating the opt-out for nonfederal governmental health
plans.
Subtitle D--Mental Health and Substance Use Disorder Parity
Implementation
Sec. 331. Grants to support mental health and substance use disorder
parity implementation.
TITLE IV--CHILDREN AND YOUTH
Subtitle A--Supporting Children's Mental Health Care Access
Sec. 401. Pediatric mental health care access grants.
Sec. 402. Infant and early childhood mental health promotion,
intervention, and treatment.
Subtitle B--Continuing Systems of Care for Children
Sec. 411. Comprehensive Community Mental Health Services for Children
with Serious Emotional Disturbances.
Sec. 412. Substance Use Disorder Treatment and Early Intervention
Services for Children and Adolescents.
Subtitle C--Garrett Lee Smith Memorial Reauthorization
Sec. 421. Suicide prevention technical assistance center.
Sec. 422. Youth suicide early intervention and prevention strategies.
Sec. 423. Mental health and substance use disorder services for
students in higher education.
Sec. 424. Mental and behavioral health outreach and education at
institutions of higher education.
TITLE I--MENTAL HEALTH AND CRISIS CARE NEEDS
Subtitle A--Crisis Care Services and 9-8-8 Implementation
SEC. 101. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE.
Part A of title V of the Public Health Service Act (42 U.S.C. 290aa
et seq.) is amended by adding at the end the following:
``SEC. 506B. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE.
``(a) In General.--The Secretary shall establish, within the
Substance Abuse and Mental Health Services Administration, an office to
coordinate work relating to behavioral health crisis care across the
operating divisions and agencies of the Department of Health and Human
Services, including the Substance Abuse and Mental Health Services
Administration, the Centers for Medicare & Medicaid Services, and the
Health Resources and Services Administration, and external
stakeholders.
``(b) Duty.--The office established under subsection (a) shall--
``(1) convene Federal, State, Tribal, local, and private
partners;
``(2) launch and manage Federal workgroups charged with
making recommendations regarding behavioral health crisis
issues, including with respect to health care best practices,
workforce development, mental health disparities, data
collection, technology, program oversight, public awareness,
and engagement; and
``(3) support technical assistance, data analysis, and
evaluation functions in order to assist States, localities,
Territories, Tribes, and Tribal communities to develop crisis
care systems and establish nationwide best practices with the
objective of expanding the capacity of, and access to, local
crisis call centers, mobile crisis care, crisis stabilization,
psychiatric emergency services, and rapid post-crisis follow-up
care provided by--
``(A) the National Suicide Prevention and Mental
Health Crisis Hotline and Response System;
``(B) community mental health centers (as defined in
section 1861(ff)(3)(B) of the Social Security Act);
``(C) certified community behavioral health clinics,
as described in section 223 of the Protecting Access to
Medicare Act of 2014; and
``(D) other community mental health and substance use
disorder providers.
``(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2023 through 2027.''.
SEC. 102. CRISIS RESPONSE CONTINUUM OF CARE.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb-31 et seq.) is amended by adding at the end the following:
``SEC. 520N. CRISIS RESPONSE CONTINUUM OF CARE.
``(a) In General.--The Secretary shall publish best practices for a
crisis response continuum of care for use by health care providers,
crisis services administrators, and crisis services providers in
responding to individuals (including children and adolescents)
experiencing mental health crises, substance-related crises, and crises
arising from co-occurring disorders.
``(b) Best Practices.--
``(1) Scope of best practices.--The best practices published
under subsection (a) shall define--
``(A) a minimum set of core crisis response services,
as determined by the Secretary, for each entity that
furnishes such services, that--
``(i) do not require prior authorization from
an insurance provider or group health plan nor
a referral from a health care provider prior to
the delivery of services;
``(ii) provide for serving all individuals
regardless of age or ability to pay;
``(iii) provide for operating 24 hours a day,
7 days a week; and
``(iv) provide for care and support through
resources described in paragraph (2)(A) until
the individual has been stabilized or
transferred to the next level of crisis care;
and
``(B) psychiatric stabilization, including the point
at which a case may be closed for--
``(i) individuals screened over the phone;
and
``(ii) individuals stabilized on the scene by
mobile teams.
``(2) Identification of essential functions.--The best
practices published under subsection (a) shall identify the
essential functions of each service in the crisis response
continuum, which shall include at least the following:
``(A) Identification of resources for referral and
enrollment in continuing mental health, substance use,
or other human services relevant for the individual in
crisis where necessary.
``(B) Delineation of access and entry points to
services within the crisis response continuum.
``(C) Development of protocols and agreements for the
transfer and receipt of individuals to and from other
segments of the crisis response continuum segments as
needed, and from outside referrals including health
care providers, first responders including law
enforcement, paramedics, and firefighters, education
institutions, and community-based organizations.
``(D) Description of the qualifications of crisis
services staff, including roles for physicians,
licensed clinicians, case managers, and peers (in
accordance with State licensing requirements or
requirements applicable to Tribal health
professionals).
``(E) The convening of collaborative meetings of
crisis response service providers, first responders
including law enforcement, paramedics, and
firefighters, and community partners (including
National Suicide Prevention Lifeline or 9-8-8 call
centers, 9-1-1 public service answering points, and
local mental health and substance use disorder
treatment providers) operating in a common region for
the discussion of case management, best practices, and
general performance improvement.
``(3) Service capacity and quality best practices.--The best
practices under subsection (a) shall include recommendations
on--
``(A) adequate volume of services to meet population
need;
``(B) appropriate timely response; and
``(C) capacity to meet the needs of different patient
populations that may experience a mental health or
substance use crisis, including children, families, and
all age groups, cultural and linguistic minorities,
individuals with co-occurring mental health and
substance use disorders, individuals with cognitive
disabilities, individuals with developmental delays,
and individuals with chronic medical conditions and
physical disabilities.
``(4) Implementation timeframe.--The Secretary shall--
``(A) not later than 1 year after the date of
enactment of this section, publish and maintain the
best practices required by subsection (a); and
``(B) every two years thereafter, publish updates.
``(5) Data collection and evaluations.--The Secretary,
directly or through grants, contracts, or interagency
agreements, shall collect data and conduct evaluations with
respect to the provision of services and programs offered on
the crisis response continuum for purposes of assessing the
extent to which the provision of such services and programs
meet certain objectives and outcomes measures as determined by
the Secretary. Such objectives shall include--
``(A) a reduction in reliance on law enforcement
response, as appropriate, to individuals in crisis who
would be more appropriately served by a mobile crisis
team capable of responding to mental health and
substance-related crises;
``(B) a reduction in boarding or extended holding of
patients in emergency room facilities who require
further psychiatric care, including care for substance
use disorders;
``(C) evidence of adequate access to crisis care
centers and crisis bed services; and
``(D) evidence of adequate linkage to appropriate
post-crisis care and longitudinal treatment for mental
health or substance use disorder when relevant.''.
Subtitle B--Into the Light for Maternal Mental Health and Substance Use
Disorders
SEC. 111. SCREENING AND TREATMENT FOR MATERNAL MENTAL HEALTH AND
SUBSTANCE USE DISORDERS.
(a) In General.--Section 317L-1 of the Public Health Service Act (42
U.S.C. 247b-13a) is amended--
(1) in the section heading, by striking ``maternal
depression'' and inserting ``maternal mental health and
substance use disorders''; and
(2) in subsection (a)--
(A) by inserting ``, Indian Tribes and Tribal
organizations (as such terms are defined in section 4
of the Indian Self-Determination and Education
Assistance Act), and Urban Indian organizations (as
such term is defined under the Federally Recognized
Indian Tribe List Act of 1994)'' after ``States''; and
(B) by striking ``for women who are pregnant, or who
have given birth within the preceding 12 months, for
maternal depression'' and inserting ``for women who are
postpartum, pregnant, or have given birth within the
preceding 12 months, for maternal mental health and
substance use disorders''.
(b) Application.--Subsection (b) of section 317L-1 of the Public
Health Service Act (42 U.S.C. 247b-13a) is amended--
(1) by striking ``a State shall submit'' and inserting ``an
entity listed in subsection (a) shall submit''; and
(2) in paragraphs (1) and (2), by striking ``maternal
depression'' each place it appears and inserting ``maternal
mental health and substance use disorders''.
(c) Priority.--Subsection (c) of section 317L-1 of the Public Health
Service Act (42 U.S.C. 247b-13a) is amended--
(1) by striking ``may give priority to States proposing to
improve or enhance access to screening'' and inserting the
following: ``shall give priority to entities listed in
subsection (a) that--
``(1) are proposing to create, improve, or enhance screening,
prevention, and treatment'';
(2) by striking ``maternal depression'' and inserting
``maternal mental health and substance use disorders'';
(3) by striking the period at the end of paragraph (1), as so
designated, and inserting a semicolon; and
(4) by inserting after such paragraph (1) the following:
``(2) are currently partnered with, or will partner with, a
community-based organization to address maternal mental health
and substance use disorders;
``(3) are located in an area with high rates of adverse
maternal health outcomes or significant health, economic,
racial, or ethnic disparities in maternal health and substance
use disorder outcomes; and
``(4) operate in a health professional shortage area
designated under section 332.''.
(d) Use of Funds.--Subsection (d) of section 317L-1 of the Public
Health Service Act (42 U.S.C. 247b-13a) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``to health care
providers; and'' and inserting ``on maternal mental
health and substance use disorder screening, brief
intervention, treatment (as applicable for health care
providers), and referrals for treatment to health care
providers in the primary care setting and nonclinical
perinatal support workers;'';
(B) in subparagraph (B), by striking ``to health care
providers, including information on maternal depression
screening, treatment, and followup support services,
and linkages to community-based resources; and'' and
inserting ``on maternal mental health and substance use
disorder screening, brief intervention, treatment (as
applicable for health care providers) and referrals for
treatment, follow-up support services, and linkages to
community-based resources to health care providers in
the primary care setting and clinical perinatal support
workers; and''; and
(C) by adding at the end the following:
``(C) enabling health care providers (such as
obstetrician-gynecologists, nurse practitioners, nurse
midwives, pediatricians, psychiatrists, mental and
other behavioral health care providers, and adult
primary care clinicians) to provide or receive real-
time psychiatric consultation (in-person or remotely),
including through the use of technology-enabled
collaborative learning and capacity building models (as
defined in section 330N), to aid in the treatment of
pregnant and postpartum women; and''; and
(2) in paragraph (2)--
(A) by striking subparagraph (A) and redesignating
subparagraphs (B) and (C) as subparagraphs (A) and (B),
respectively;
(B) in subparagraph (A), as redesignated, by striking
``and'' at the end;
(C) in subparagraph (B), as redesignated--
(i) by inserting ``, including'' before ``for
rural areas''; and
(ii) by striking the period at the end and
inserting a semicolon; and
(D) by inserting after subparagraph (B), as
redesignated, the following:
``(C) providing assistance to pregnant and postpartum
women to receive maternal mental health and substance
use disorder treatment, including patient consultation,
care coordination, and navigation for such treatment;
``(D) coordinating with maternal and child health
programs of the Federal Government and State, local,
and Tribal governments, including child psychiatric
access programs;
``(E) conducting public outreach and awareness
regarding grants under subsection (a);
``(F) creating multistate consortia to carry out the
activities required or authorized under this
subsection; and
``(G) training health care providers in the primary
care setting and nonclinical perinatal support workers
on trauma-informed care, culturally and linguistically
appropriate services, and best practices related to
training to improve the provision of maternal mental
health and substance use disorder care for racial and
ethnic minority populations, including with respect to
perceptions and biases that may affect the approach to,
and provision of, care.''.
(e) Additional Provisions.--Section 317L-1 of the Public Health
Service Act (42 U.S.C. 247b-13a) is amended--
(1) by redesignating subsection (e) as subsection (h); and
(2) by inserting after subsection (d) the following:
``(e) Technical Assistance.--The Secretary shall provide technical
assistance to grantees and entities listed in subsection (a) for
carrying out activities pursuant to this section.
``(f) Dissemination of Best Practices.--The Secretary, based on
evaluation of the activities funded pursuant to this section, shall
identify and disseminate evidence-based or evidence-informed best
practices for screening, assessment, and treatment services for
maternal mental health and substance use disorders, including
culturally and linguistically appropriate services, for women during
pregnancy and 12 months following pregnancy.
``(g) Matching Requirement.--The Federal share of the cost of the
activities for which a grant is made to an entity under subsection (a)
shall not exceed 90 percent of the total cost of such activities.''.
(f) Authorization of Appropriations.--Subsection (h) of section 317L-
1 (42 U.S.C. 247b-13a) of the Public Health Service Act, as
redesignated, is further amended--
(1) by striking ``$5,000,000'' and inserting ``$24,000,000'';
and
(2) by striking ``2018 through 2022'' and inserting ``2023
through 2027''.
SEC. 112. MATERNAL MENTAL HEALTH HOTLINE.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g
et seq.) is amended by adding at the end the following:
``SEC. 399V-7. MATERNAL MENTAL HEALTH HOTLINE.
``(a) In General.--The Secretary shall maintain, directly or by grant
or contract, a national hotline to provide emotional support,
information, brief intervention, and mental health and substance use
disorder resources to pregnant and postpartum women at risk of, or
affected by, maternal mental health and substance use disorders, and to
their families or household members.
``(b) Requirements for Hotline.--The hotline under subsection (a)
shall--
``(1) be a 24/7 real-time hotline;
``(2) provide voice and text support;
``(3) be staffed by certified peer specialists, licensed
health care professionals, or licensed mental health
professionals who are trained on--
``(A) maternal mental health and substance use
disorder prevention, identification, and intervention;
and
``(B) providing culturally and linguistically
appropriate support; and
``(4) provide maternal mental health and substance use
disorder assistance and referral services to meet the needs of
underserved populations, individuals with disabilities, and
family and household members of pregnant or postpartum women at
risk of experiencing maternal mental health and substance use
disorders.
``(c) Additional Requirements.--In maintaining the hotline under
subsection (a), the Secretary shall--
``(1) consult with the Domestic Violence Hotline, National
Suicide Prevention Lifeline, and Veterans Crisis Line to ensure
that pregnant and postpartum women are connected in real-time
to the appropriate specialized hotline service, when
applicable;
``(2) conduct a public awareness campaign for the hotline;
and
``(3) consult with Federal departments and agencies,
including the Centers of Excellence of the Substance Abuse and
Mental Health Services Administration and the Department of
Veterans Affairs, to increase awareness regarding the hotline.
``(d) Annual Report.--The Secretary shall submit an annual report to
the Congress on the hotline under subsection (a) and implementation of
this section, including--
``(1) an evaluation of the effectiveness of activities
conducted or supported under subsection (a);
``(2) a directory of entities or organizations to which staff
maintaining the hotline funded under this section may make
referrals; and
``(3) such additional information as the Secretary determines
appropriate.
``(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $10,000,000 for each of fiscal
years 2023 through 2027.''.
SEC. 113. TASK FORCE ON MATERNAL MENTAL HEALTH.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317L-1 (42 U.S.C. 247b-
13a) the following:
``SEC. 317L-2. TASK FORCE ON MATERNAL MENTAL HEALTH.
``(a) Establishment.--Not later than 180 days after the date of
enactment of the Restoring Hope for the Mental Health and Well-Being
Act of 2022, the Secretary, for purposes of identifying, evaluating,
and making recommendations to coordinate and improve Federal responses
to maternal mental health conditions, shall--
``(1) establish a task force to be known as the Task Force on
Maternal Mental Health (in this section referred to as the
`Task Force'); or
``(2) incorporate the duties, public meetings, and reports
specified in subsections (c) through (f) into existing Federal
policy forums, including the Maternal Health Interagency Policy
Committee and the Maternal Health Working Group, as
appropriate.
``(b) Membership.--
``(1) Composition.--The Task Force shall be composed of--
``(A) the Federal members under paragraph (2); and
``(B) the non-Federal members under paragraph (3).
``(2) Federal members.--The Federal members of the Task Force
shall consist of the following heads of Federal departments and
agencies (or their designees):
``(A) The Assistant Secretary for Health of the
Department of Health and Human Services, who shall
serve as Chair.
``(B) The Assistant Secretary for Planning and
Evaluation of the Department of Health and Human
Services.
``(C) The Assistant Secretary of the Administration
for Children and Families.
``(D) The Director of the Centers for Disease Control
and Prevention.
``(E) The Administrator of the Centers for Medicare &
Medicaid Services.
``(F) The Administrator of the Health Resources and
Services Administration.
``(G) The Director of the Indian Health Service.
``(H) The Assistant Secretary for Mental Health and
Substance Use.
``(I) Such other Federal departments and agencies as
the Secretary determines appropriate that serve
individuals with maternal mental health conditions.
``(3) Non-federal members.--The non-Federal members of the
Task Force shall--
``(A) compose not more than one-half, and not less
than one-third, of the total membership of the Task
Force;
``(B) be appointed by the Secretary; and
``(C) include--
``(i) representatives of medical societies
with expertise in maternal or mental health;
``(ii) representatives of nonprofit
organizations with expertise in maternal or
mental health;
``(iii) relevant industry representatives;
and
``(iv) other representatives, as appropriate.
``(4) Deadline for designating designees.--If the Assistant
Secretary for Health, or the head of a Federal department or
agency serving as a member of the Task Force under paragraph
(2), chooses to be represented on the Task Force by a designee,
the Assistant Secretary or department or agency head shall
designate such designee not later than 90 days after the date
of the enactment of this section.
``(c) Duties.--The Task Force shall--
``(1) prepare and regularly update a report that analyzes and
evaluates the state of national maternal mental health policy
and programs at the Federal, State, and local levels, and
identifies best practices with respect to maternal mental
health policy, including--
``(A) a set of evidence-based, evidence-informed, and
promising practices with respect to--
``(i) prevention strategies for individuals
at risk of experiencing a maternal mental
health condition, including strategies and
recommendations to address health inequities;
``(ii) the identification, screening,
diagnosis, intervention, and treatment of
individuals and families affected by a maternal
mental health condition;
``(iii) the expeditious referral to, and
implementation of, practices and supports that
prevent and mitigate the effects of a maternal
mental health condition, including strategies
and recommendations to eliminate the racial and
ethnic disparities that exist in maternal
mental health; and
``(iv) community-based or multigenerational
practices that support individuals and families
affected by a maternal mental health condition;
and
``(B) Federal and State programs and activities to
prevent, screen, diagnose, intervene, and treat
maternal mental health conditions;
``(2) develop and regularly update a national strategy for
maternal mental health, taking into consideration the findings
of the report under paragraph (1), on how the Task Force and
Federal departments and agencies represented on the Task Force
may prioritize options for, and may implement a coordinated
approach to, addressing maternal mental health conditions,
including by--
``(A) increasing prevention, screening, diagnosis,
intervention, treatment, and access to care, including
clinical and nonclinical care such as peer-support and
community health workers, through the public and
private sectors;
``(B) providing support for pregnant or postpartum
individuals who are at risk for or experiencing a
maternal mental health condition, and their families,
as appropriate;
``(C) reducing racial, ethnic, geographic, and other
health disparities for prevention, diagnosis,
intervention, treatment, and access to care;
``(D) identifying options for modifying,
strengthening, and coordinating Federal programs and
activities, such as the Medicaid program under title
XIX of the Social Security Act and the State Children's
Health Insurance Program under title XXI of such Act,
including existing infant and maternity programs, in
order to increase research, prevention, identification,
intervention, and treatment with respect to maternal
mental health; and
``(E) planning, data sharing, and communication
within and across Federal departments, agencies,
offices, and programs;
``(3) solicit public comments from stakeholders for the
report under paragraph (1) and the national strategy under
paragraph (2), including comments from frontline service
providers, mental health professionals, researchers, experts in
maternal mental health, institutions of higher education,
public health agencies (including maternal and child health
programs), and industry representatives, in order to inform the
activities and reports of the Task Force; and
``(4) disaggregate any data collected under this section by
race, ethnicity, geographical location, age, marital status,
socioeconomic level, and other factors, as the Secretary
determines appropriate.
``(d) Meetings.--The Task Force shall--
``(1) meet not less than two times each year; and
``(2) convene public meetings, as appropriate, to fulfill its
duties under this section.
``(e) Reports to Public and Federal Leaders.--The Task Force shall
make publicly available and submit to the heads of relevant Federal
departments and agencies, the Committee on Energy and Commerce of the
House of Representatives, the Committee on Health, Education, Labor,
and Pensions of the Senate, and other relevant congressional
committees, the following:
``(1) Not later than 1 year after the first meeting of the
Task Force, an initial report under subsection (c)(1).
``(2) Not later than 2 years after the first meeting of the
Task Force, an initial national strategy under subsection
(c)(2).
``(3) Each year thereafter--
``(A) an updated report under subsection (c)(1);
``(B) an updated national strategy under subsection
(c)(2); or
``(C) if no update is made under subsection (c)(1) or
(c)(2), a report summarizing the activities of the Task
Force.
``(f) Reports to Governors.--Upon finalizing the initial national
strategy under subsection (c)(2), and upon making relevant updates to
such strategy, the Task Force shall submit a report to the Governors of
all States describing opportunities for local- and State-level
partnerships identified under subsection (c)(2)(D).
``(g) Sunset.--The Task Force shall terminate on September 30, 2027.
``(h) Nonduplication of Federal Efforts.--The Secretary may relieve
the Task Force, in carrying out subsections (c) through (f), from
responsibility for carrying out such activities as may be specified by
the Secretary as duplicative with other activities carried out by the
Department of Health and Human Services.''.
Subtitle C--Reaching Improved Mental Health Outcomes for Patients
SEC. 121. INNOVATION FOR MENTAL HEALTH.
(a) National Mental Health and Substance Use Policy Laboratory.--
Section 501A of the Public Health Service Act (42 U.S.C. 290aa-0) is
amended--
(1) in subsection (e)(1), by striking ``Indian tribes or
tribal organizations'' and inserting ``Indian Tribes or Tribal
organizations'';
(2) by striking subsection (e)(3); and
(3) by adding at the end the following:
``(f) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2023 through 2027.''.
(b) Interdepartmental Serious Mental Illness Coordinating
Committee.--
(1) In general.--Part A of title V of the Public Health
Service Act (42 U.S.C. 290aa et seq.) is amended by inserting
after section 501A (42 U.S.C. 290aa-0) the following:
``SEC. 501B. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
COMMITTEE.
``(a) Establishment.--
``(1) In general.--The Secretary of Health and Human
Services, or the designee of the Secretary, shall establish a
committee to be known as the Interdepartmental Serious Mental
Illness Coordinating Committee (in this section referred to as
the `Committee').
``(2) Federal advisory committee act.--Except as provided in
this section, the provisions of the Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Committee.
``(b) Meetings.--The Committee shall meet not fewer than 2 times each
year.
``(c) Responsibilities.--The Committee shall submit, on a biannual
basis, to Congress and any other relevant Federal department or agency
a report including--
``(1) a summary of advances in serious mental illness and
serious emotional disturbance research related to the
prevention of, diagnosis of, intervention in, and treatment and
recovery of serious mental illnesses, serious emotional
disturbances, and advances in access to services and support
for adults with a serious mental illness or children with a
serious emotional disturbance;
``(2) an evaluation of the effect Federal programs related to
serious mental illness have on public health, including public
health outcomes such as--
``(A) rates of suicide, suicide attempts, incidence
and prevalence of serious mental illnesses, serious
emotional disturbances, and substance use disorders,
overdose, overdose deaths, emergency hospitalizations,
emergency room boarding, preventable emergency room
visits, interaction with the criminal justice system,
homelessness, and unemployment;
``(B) increased rates of employment and enrollment in
educational and vocational programs;
``(C) quality of mental and substance use disorders
treatment services; or
``(D) any other criteria as may be determined by the
Secretary; and
``(3) specific recommendations for actions that agencies can
take to better coordinate the administration of mental health
services for adults with a serious mental illness or children
with a serious emotional disturbance.
``(d) Membership.--
``(1) Federal members.--The Committee shall be composed of
the following Federal representatives, or the designees of such
representatives--
``(A) the Secretary of Health and Human Services, who
shall serve as the Chair of the Committee;
``(B) the Assistant Secretary for Mental Health and
Substance Use;
``(C) the Attorney General;
``(D) the Secretary of Veterans Affairs;
``(E) the Secretary of Defense;
``(F) the Secretary of Housing and Urban Development;
``(G) the Secretary of Education;
``(H) the Secretary of Labor;
``(I) the Administrator of the Centers for Medicare &
Medicaid Services; and
``(J) the Commissioner of Social Security.
``(2) Non-federal members.--The Committee shall also include
not less than 14 non-Federal public members appointed by the
Secretary of Health and Human Services, of which--
``(A) at least 2 members shall be an individual who
has received treatment for a diagnosis of a serious
mental illness;
``(B) at least 1 member shall be a parent or legal
guardian of an adult with a history of a serious mental
illness or a child with a history of a serious
emotional disturbance;
``(C) at least 1 member shall be a representative of
a leading research, advocacy, or service organization
for adults with a serious mental illness;
``(D) at least 2 members shall be--
``(i) a licensed psychiatrist with experience
in treating serious mental illnesses;
``(ii) a licensed psychologist with
experience in treating serious mental illnesses
or serious emotional disturbances;
``(iii) a licensed clinical social worker
with experience treating serious mental
illnesses or serious emotional disturbances; or
``(iv) a licensed psychiatric nurse, nurse
practitioner, or physician assistant with
experience in treating serious mental illnesses
or serious emotional disturbances;
``(E) at least 1 member shall be a licensed mental
health professional with a specialty in treating
children and adolescents with a serious emotional
disturbance;
``(F) at least 1 member shall be a mental health
professional who has research or clinical mental health
experience in working with minorities;
``(G) at least 1 member shall be a mental health
professional who has research or clinical mental health
experience in working with medically underserved
populations;
``(H) at least 1 member shall be a State certified
mental health peer support specialist;
``(I) at least 1 member shall be a judge with
experience in adjudicating cases related to criminal
justice or serious mental illness;
``(J) at least 1 member shall be a law enforcement
officer or corrections officer with extensive
experience in interfacing with adults with a serious
mental illness, children with a serious emotional
disturbance, or individuals in a mental health crisis;
and
``(K) at least 1 member shall have experience
providing services for homeless individuals and working
with adults with a serious mental illness, children
with a serious emotional disturbance, or individuals in
a mental health crisis.
``(3) Terms.--A member of the Committee appointed under
paragraph (2) shall serve for a term of 3 years, and may be
reappointed for 1 or more additional 3-year terms. Any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A member may serve
after the expiration of the member's term until a successor has
been appointed.
``(e) Working Groups.--In carrying out its functions, the Committee
may establish working groups. Such working groups shall be composed of
Committee members, or their designees, and may hold such meetings as
are necessary.
``(f) Sunset.--The Committee shall terminate on September 30,
2027.''.
(2) Conforming amendments.--
(A) Section 501(l)(2) of the Public Health Service
Act (42 U.S.C. 290aa(l)(2)) is amended by striking
``section 6031 of such Act'' and inserting ``section
501B of this Act''.
(B) Section 6031 of the Helping Families in Mental
Health Crisis Reform Act of 2016 (Division B of Public
Law 114-255) is repealed (and by conforming the item
relating to such section in the table of contents in
section 1(b)).
(c) Priority Mental Health Needs of Regional and National
Significance.--Section 520A of the Public Health Service Act (42 U.S.C.
290bb-32) is amended--
(1) in subsection (a), by striking ``Indian tribes or tribal
organizations'' and inserting ``Indian Tribes or Tribal
organizations''; and
(2) in subsection (f), by striking ``$394,550,000 for each of
fiscal years 2018 through 2022'' and inserting ``$599,036,000
for each of fiscal years 2023 through 2027''.
SEC. 122. CRISIS CARE COORDINATION.
(a) Strengthening Community Crisis Response Systems.--Section 520F of
the Public Health Service Act (42 U.S.C. 290bb-37) is amended to read
as follows:
``SEC. 520F. MENTAL HEALTH CRISIS RESPONSE PARTNERSHIP PILOT PROGRAM.
``(a) In General.--The Secretary shall establish a pilot program
under which the Secretary will award competitive grants to States,
localities, territories, Indian Tribes, and Tribal organizations to
establish new, or enhance existing, mobile crisis response teams that
divert the response for mental health and substance use crises from law
enforcement to mobile crisis teams, as described in subsection (b).
``(b) Mobile Crisis Teams Described.--A mobile crisis team described
in this subsection is a team of individuals--
``(1) that is available to respond to individuals in crisis
and provide immediate stabilization, referrals to community-
based mental health and substance use disorder services and
supports, and triage to a higher level of care if medically
necessary;
``(2) which may include licensed counselors, clinical social
workers, physicians, paramedics, crisis workers, peer support
specialists, or other qualified individuals; and
``(3) which may provide support to divert behavioral health
crisis calls from the 9-1-1 system to the 9-8-8 system.
``(c) Priority.--In awarding grants under this section, the Secretary
shall prioritize applications which account for the specific needs of
the communities to be served, including children and families,
veterans, rural and underserved populations, and other groups at
increased risk of death from suicide or overdose.
``(d) Report.--
``(1) Initial report.--Not later than September 30, 2024, the
Secretary shall submit to Congress a report on steps taken by
the entities specified in subsection (a) as of such date of
enactment to strengthen the partnerships among mental health
providers, substance use disorder treatment providers, primary
care physicians, mental health and substance use crisis teams,
paramedics, law enforcement officers, and other first
responders.
``(2) Progress reports.--Not later than one year after the
date on which the first grant is awarded to carry out this
section, and for each year thereafter, the Secretary shall
submit to Congress a report on the grants made during the year
covered by the report, which shall include--
``(A) impact data on the teams and people served by
such programs, including demographic information of
individuals served, volume, and types of service
utilization;
``(B) outcomes of the number of linkages to
community-based resources, short-term crisis receiving
and stabilization facilities, and diversion from law
enforcement or hospital emergency department settings;
``(C) data consistent with the State block grant
requirements for continuous evaluation and quality
improvement, and other relevant data as determined by
the Secretary; and
``(D) the Secretary's recommendations and best
practices for--
``(i) States and localities providing mobile
crisis response and stabilization services for
youth and adults; and
``(ii) improvements to the program
established under this section.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $10,000,000 for each of fiscal
years 2023 through 2027.''.
(b) Mental Health Awareness Training Grants.--
(1) In general.--Section 520J(b) of the Public Health Service
Act (42 U.S.C. 290bb-41(b)) is amended--
(A) in paragraph (1), by striking ``Indian tribes,
tribal organizations'' and inserting ``Indian Tribes,
Tribal organizations'';
(B) in paragraph (4), by striking ``Indian tribe,
tribal organization'' and inserting ``Indian Tribe,
Tribal organization'';
(C) in paragraph (5)--
(i) by striking ``Indian tribe, tribal
organization'' and inserting ``Indian Tribe,
Tribal organization'';
(ii) in subparagraph (A), by striking ``and''
at the end;
(iii) in subparagraph (B)(ii), by striking
the period at the end and inserting ``; and'';
and
(iv) by adding at the end the following:
``(C) suicide intervention and prevention, including
recognizing warning signs and how to refer someone for
help.'';
(D) in paragraph (6), by striking ``Indian tribe,
tribal organization'' and inserting ``Indian Tribe,
Tribal organization''; and
(E) in paragraph (7), by striking ``$14,693,000 for
each of fiscal years 2018 through 2022'' and inserting
``$24,963,000 for each of fiscal years 2023 through
2027''.
(2) Technical corrections.--Section 520J(b) of the Public
Health Service Act (42 U.S.C. 290bb-41(b)) is amended--
(A) in the heading of paragraph (2), by striking
``Emergency Services Personnel'' and inserting
``Emergency services personnel''; and
(B) in the heading of paragraph (3), by striking
``Distribution of Awards'' and inserting ``Distribution
of awards''.
(c) Adult Suicide Prevention.--Section 520L of the Public Health
Service Act (42 U.S.C. 290bb-43) is amended--
(1) in subsection (a)--
(A) in paragraph (2)--
(i) by striking ``Indian tribe'' each place
it appears and inserting ``Indian Tribe''; and
(ii) by striking ``tribal organization'' each
place it appears and inserting ``Tribal
organization''; and
(B) by amending paragraph (3)(C) to read as follows:
``(C) Raising awareness of suicide prevention
resources, promoting help seeking among those at risk
for suicide.''; and
(2) in subsection (d), by striking ``$30,000,000 for the
period of fiscal years 2018 through 2022'' and inserting
``$30,000,000 for each of fiscal years 2023 through 2027''.
SEC. 123. TREATMENT OF SERIOUS MENTAL ILLNESS.
(a) Assertive Community Treatment Grant Program.--
(1) Technical amendment.--Section 520M(b) of the Public
Health Service Act (42 U.S.C. 290bb-44(b)) is amended by
striking ``Indian tribe or tribal organization'' and inserting
``Indian Tribe or Tribal organization''.
(2) Report to congress.--Section 520M(d)(1) of the Public
Health Service Act (42 U.S.C. 290bb-44(d)(1)) is amended by
striking ``not later than the end of fiscal year 2021'' and
inserting ``not later than the end of fiscal year 2026''.
(3) Authorization of appropriations.--Section 520M(e)(1) of
the Public Health Service Act (42 U.S.C. 290bb-44(d)(1)) is
amended by striking ``$5,000,000 for the period of fiscal years
2018 through 2022'' and inserting ``$9,000,000 for each of
fiscal years 2023 through 2027''.
(b) Assisted Outpatient Treatment.--Section 224 of the Protecting
Access to Medicare Act of 2014 (42 U.S.C. 290aa note) is amended to
read as follows:
``SEC. 224. ASSISTED OUTPATIENT TREATMENT GRANT PROGRAM FOR INDIVIDUALS
WITH SERIOUS MENTAL ILLNESS.
``(a) In General.--The Secretary shall carry out a program to award
grants to eligible entities for assisted outpatient treatment programs
for individuals with serious mental illness.
``(b) Consultation.--The Secretary shall carry out this section in
consultation with the Director of the National Institute of Mental
Health, the Attorney General of the United States, the Administrator of
the Administration for Community Living, and the Assistant Secretary
for Mental Health and Substance Use.
``(c) Selecting Among Applicants.--In awarding grants under this
section, the Secretary--
``(1) may give preference to applicants that have not
previously implemented an assisted outpatient treatment
program; and
``(2) shall evaluate applicants based on their potential to
reduce hospitalization, homelessness, incarceration, and
interaction with the criminal justice system while improving
the health and social outcomes of the patient.
``(d) Program Requirements.--An assisted outpatient treatment program
funded with a grant awarded under this section shall include--
``(1) evaluating the medical and social needs of the patients
who are participating in the program;
``(2) preparing and executing treatment plans for such
patients that--
``(A) include criteria for completion of court-
ordered treatment if applicable; and
``(B) provide for monitoring of the patient's
compliance with the treatment plan, including
compliance with medication and other treatment
regimens;
``(3) providing for case management services that support the
treatment plan;
``(4) ensuring appropriate referrals to medical and social
services providers;
``(5) evaluating the process for implementing the program to
ensure consistency with the patient's needs and State law; and
``(6) measuring treatment outcomes, including health and
social outcomes such as rates of incarceration, health care
utilization, and homelessness.
``(e) Report.--Not later than the end of fiscal year 2027, the
Secretary shall submit a report to the appropriate congressional
committees on the grant program under this section. Such report shall
include an evaluation of the following:
``(1) Cost savings and public health outcomes such as
mortality, suicide, substance abuse, hospitalization, and use
of services.
``(2) Rates of incarceration of patients.
``(3) Rates of homelessness of patients.
``(4) Patient and family satisfaction with program
participation.
``(5) Demographic information regarding participation of
those served by the grant compared to demographic information
in the population of the grant recipient.
``(f) Definitions.--In this section:
``(1) The term `assisted outpatient treatment' means
medically prescribed mental health treatment that a patient
receives while living in a community under the terms of a law
authorizing a State or local civil court to order such
treatment.
``(2) The term `eligible entity' means a county, city, mental
health system, mental health court, or any other entity with
authority under the law of the State in which the entity is
located to implement, monitor, and oversee an assisted
outpatient treatment program.
``(g) Funding.--
``(1) Amount of grants.--
``(A) Maximum amount.--The amount of a grant under
this section shall not exceed $1,000,000 for any fiscal
year.
``(B) Determination.--Subject to subparagraph (A),
the Secretary shall determine the amount of each grant
under this section based on the population of the area
to be served through the grant and an estimate of the
number of patients to be served.
``(2) Authorization of appropriations.--There is authorized
to be appropriated to carry out this section $22,000,000 for
each of fiscal years 2023 through 2027.''.
Subtitle D--Anna Westin Legacy
SEC. 131. MAINTAINING EDUCATION AND TRAINING ON EATING DISORDERS.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb-31 et seq.), as amended by section 102, is further amended
by adding at the end the following:
``SEC. 520O. CENTER OF EXCELLENCE FOR EATING DISORDERS FOR EDUCATION
AND TRAINING ON EATING DISORDERS.
``(a) In General.--The Secretary, acting through the Assistant
Secretary, shall maintain, by competitive grant or contract, a Center
of Excellence for Eating Disorders (referred to in this section as the
`Center') to improve the identification of, interventions for, and
treatment of eating disorders in a manner that is developmentally,
culturally, and linguistically appropriate.
``(b) Subgrants and Subcontracts.--The Center shall coordinate and
implement the activities under subsection (c), in whole or in part, by
awarding competitive subgrants or subcontracts--
``(1) across geographical regions; and
``(2) in a manner that is not duplicative.
``(c) Activities.--The Center--
``(1) shall--
``(A) provide training and technical assistance for--
``(i) primary care and behavioral health care
providers to carry out screening, brief
intervention, and referral to treatment for
individuals experiencing, or at risk for,
eating disorders; and
``(ii) nonclinical community support workers
to identify and support individuals with, or at
disproportionate risk for, eating disorders;
``(B) develop and provide training materials to
health care providers, including primary care and
behavioral health care providers, in the effective
treatment and ongoing support of individuals with
eating disorders, including children and marginalized
populations at disproportionate risk for eating
disorders;
``(C) provide collaboration and coordination to other
centers of excellence, technical assistance centers,
and psychiatric consultation lines of the Substance
Abuse and Mental Health Services Administration and the
Health Resources and Services Administration on the
identification, effective treatment, and ongoing
support of individuals with eating disorders; and
``(D) coordinate with the Director of the Centers for
Disease Control and Prevention and the Administrator of
the Health Resources and Services Administration to
disseminate training to primary care and behavioral
health care providers; and
``(2) may--
``(A) coordinate with electronic health record
systems for the integration of protocols pertaining to
screening, brief intervention, and referral to
treatment for individuals experiencing, or at risk for,
eating disorders;
``(B) develop and provide training materials to
health care providers, including primary care and
behavioral health care providers, in the effective
treatment and ongoing support for members of the Armed
Forces and veterans experiencing, or at risk for,
eating disorders; and
``(C) consult with the Secretary of Defense and the
Secretary of Veterans Affairs on prevention,
identification, intervention for, and treatment of
eating disorders.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $1,000,000 for each of fiscal
years 2023 through 2027.''.
Subtitle E--Community Mental Health Services Block Grant
Reauthorization
SEC. 141. REAUTHORIZATION OF BLOCK GRANTS FOR COMMUNITY MENTAL HEALTH
SERVICES.
(a) Funding.--Section 1920(a) of the Public Health Service Act (42
U.S.C. 300x-9(a)) is amended by striking ``$532,571,000 for each of
fiscal years 2018 through 2022'' and inserting ``$857,571,000 for each
of fiscal years 2023 through 2027''.
(b) Set-Aside for Evidence-based Crisis Care Services.--Section 1920
of the Public Health Service Act (42 U.S.C. 300x-9) is amended by
adding at the end the following:
``(d) Crisis Care.--
``(1) In general.--Except as provided in paragraph (3), a
State shall expend at least 5 percent of the amount the State
receives pursuant to section 1911 for each fiscal year to
support evidenced-based programs that address the crisis care
needs of--
``(A) individuals, including children and
adolescents, experiencing mental health crises,
substance-related crises, or crises arising from co-
occurring disorders; and
``(B) persons with intellectual and developmental
disabilities.
``(2) Core elements.--At the discretion of the single State
agency responsible for the administration of the program of the
State under a grant under section 1911, funds expended pursuant
to paragraph (1) may be used to fund some or all of the core
crisis care service components, delivered according to
evidence-based principles, including the following:
``(A) Crisis call centers.
``(B) 24/7 mobile crisis services.
``(C) Crisis stabilization programs offering acute
care or subacute care in a hospital or appropriately
licensed facility, as determined by the Substance Abuse
and Mental Health Services Administration, with
referrals to inpatient or outpatient care.
``(3) State flexibility.--In lieu of expending 5 percent of
the amount the State receives pursuant to section 1911 for a
fiscal year to support evidence-based programs as required by
paragraph (1), a State may elect to expend not less than 10
percent of such amount to support such programs by the end of
two consecutive fiscal years.
``(4) Rule of construction.--With respect to funds expended
pursuant to the set-aside in paragraph (1), section
1912(b)(1)(A)(vi) shall not apply.''.
(c) Early Intervention.--
(1) State plan option.--Section 1912(b)(1)(A)(vii) of the
Public Health Service Act (42 U.S.C. 300x-1(b)(1)(A)(vii)) is
amended--
(A) in subclause (III), by striking ``and'' at the
end;
(B) in subclause (IV), by striking the period at the
end and inserting ``; and''; and
(C) by adding at the end the following:
``(V) a description of any evidence-
based early intervention strategies and
programs the State provides to prevent,
delay, or reduce the severity and onset
of mental illness and behavioral
problems, including for children and
adolescents, irrespective of
experiencing a serious mental illness
or serious emotional disturbance, as
defined under subsection (c)(1).''.
(2) Allocation allowance; reports.--Section 1920 of the
Public Health Service Act (42 U.S.C. 300x-9), as amended by
subsection (c), is further amended by adding at the end the
following:
``(e) Early Intervention Services.--In the case of a State with a
State plan that provides for strategies and programs specified in
section 1912(b)(1)(A)(vii)(VI), such State may expend not more than 5
percent of the amount of the allotment of the State pursuant to a
funding agreement under section 1911 for each fiscal year to support
such strategies and programs.
``(f) Reports to Congress.--Not later than September 30, 2025, and
biennially thereafter, the Secretary shall provide a report to the
Congress on the crisis care and early intervention strategies and
programs pursued by States pursuant to subsections (d) and (e). Each
such report shall include--
``(1) a description of the each State's crisis care and early
intervention activities;
``(2) the population served, including information on
demographics, including age;
``(3) the outcomes of such activities, including--
``(A) how such activities reduced hospitalizations
and hospital stays;
``(B) how such activities reduced incidents of
suicidal ideation and behaviors; and
``(C) how such activities reduced the severity of
onset of serious mental illness and serious emotional
disturbance; and
``(4) any other relevant information the Secretary deems
necessary.''.
Subtitle F--Peer-Supported Mental Health Services
SEC. 151. PEER-SUPPORTED MENTAL HEALTH SERVICES.
Subpart 3 of part B of title V of the Public Health Service Act (42
U.S.C. 290bb--31 et seq.) is amended by inserting after section 520G
(42 U.S.C. 290bb--38) the following:
``SEC. 520H. PEER-SUPPORTED MENTAL HEALTH SERVICES.
``(a) Grants Authorized.--The Secretary, acting through the Director
of the Center for Mental Health Services, shall award grants to
eligible entities to enable such entities to develop, expand, and
enhance access to mental health peer-delivered services.
``(b) Use of Funds.--Grants awarded under subsection (a) shall be
used to develop, expand, and enhance national, statewide, or community-
focused programs, including virtual peer-support services and
infrastructure, including by--
``(1) carrying out workforce development, recruitment, and
retention activities, to train, recruit, and retain peer-
support providers;
``(2) building connections between mental health treatment
programs, including between community organizations and peer-
support networks, including virtual peer-support networks, and
with other mental health support services;
``(3) reducing stigma associated with mental health
disorders;
``(4) expanding and improving virtual peer mental health
support services, including adoption of technologies to expand
access to virtual peer mental health support services,
including by acquiring--
``(A) appropriate physical hardware for such virtual
services;
``(B) software and programs to efficiently run peer-
support services virtually; and
``(C) other technology for establishing virtual
waiting rooms and virtual video platforms for meetings;
and
``(5) conducting research on issues relating to mental
illness and the impact peer-support has on resiliency,
including identifying--
``(A) the signs of mental illness;
``(B) the resources available to individuals with
mental illness and to their families; and
``(C) the resources available to help support
individuals living with mental illness.
``(c) Special Consideration.--In carrying out this section, the
Secretary shall give special consideration to the unique needs of rural
areas.
``(d) Definition.--In this section, the term `eligible entity'
means--
``(1) a nonprofit consumer-run organization that--
``(A) is principally governed by people living with a
mental health condition; and
``(B) mobilizes resources within and outside of the
mental health community, which may include through
peer-support networks, to increase the prevalence and
quality of long-term wellness of individuals living
with a mental health condition, including those with a
co-occurring substance use disorder; or
``(2) a Federally recognized Tribe, Tribal organization,
Urban Indian organization, or consortium of Tribes or Tribal
organizations.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $13,000,000 for each of fiscal
years 2023 through 2027.''.
TITLE II--SUBSTANCE USE DISORDER PREVENTION, TREATMENT, AND RECOVERY
SERVICES
Subtitle A--Native Behavioral Health Access Improvement
SEC. 201. BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER SERVICES FOR
NATIVE AMERICANS.
Section 506A of the Public Health Service Act (42 U.S.C. 290aa-5a) is
amended to read as follows:
``SEC. 506A. BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER SERVICES FOR
NATIVE AMERICANS.
``(a) Definitions.--In this section:
``(1) The term `eligible entity' means an Indian Tribe, a
Tribal organization, an Urban Indian organization, and a Native
Hawaiian health organization.
``(2) The terms `Indian Tribe', `Tribal organization', and
`Urban Indian organization' have the meanings given to the
terms `Indian tribe', `tribal organization', and `Urban Indian
organization' in section 4 of the Indian Health Care
Improvement Act.
``(3) The term `Native Hawaiian health organization' means
`Papa Ola Lokahi' as defined in section 12 of the Native
Hawaiian Health Care Improvement Act.
``(b) Formula Funds.--
``(1) In general.--The Secretary, in consultation with the
Director of the Indian Health Service, as appropriate, shall
award funds to eligible entities, in amounts determined
pursuant to the formula described in paragraph (2), to be used
by the eligible entity to provide culturally appropriate mental
health and substance use disorder prevention, treatment, and
recovery services to American Indians, Alaska Natives, and
Native Hawaiians.
``(2) Formula.--The Secretary, using the process described in
subsection (d), shall develop a formula to determine the amount
of an award under paragraph (1). Such formula shall take into
account the populations of eligible entities whose rates of
overdose deaths or suicide are substantially higher relative to
the populations of other Indian Tribes, Tribal organizations,
Urban Indian organizations, or Native Hawaiian health
organizations, as applicable.
``(c) Technical Assistance and Program Evaluation.--
``(1) In general.--The Secretary shall--
``(A) provide technical assistance to applicants and
awardees under this section; and
``(B) collect and evaluate information on the program
carried out under this section.
``(2) Consultation on evaluation measures, and data
submission and reporting requirements.--The Secretary shall,
using the process described in subsection (d), develop
evaluation measures and data submission and reporting
requirements for purposes of the collection and evaluation of
information.
``(3) Data submission and reporting.--As a condition on
receipt of funds under this section, an applicant shall agree
to submit data and reports in a timely manner consistent with
the evaluation measures and data submission and reporting
requirements developed under subsection (d).
``(d) Regulations.--
``(1) Promulgation.--Not later than 180 days after the date
of enactment of the Restoring Hope for Mental Health and Well-
Being Act of 2022, the Secretary shall initiate procedures
under subchapter III of chapter 5 of title 5, United States
Code, to negotiate and promulgate such regulations as are
necessary to carry out this section, including development of
the funding formula described in subsection (b) and the program
evaluation and reporting requirements under subsection (c).
``(2) Publication.--Not later than 18 months after the date
of enactment of the Restoring Hope for Mental Health and Well-
Being Act of 2022, the Secretary shall publish in the Federal
Register proposed regulations to implement this section.
``(3) Committee.--A negotiated rulemaking committee
established pursuant to section 565 of title 5, United States
Code, to carry out this subsection shall have as its members
only representatives of the Federal Government, Tribal
Governments, and Urban Indian organizations. For purposes of
such rulemaking, the Indian Health Service shall be the lead
agency for the Department.
``(4) Adaptation of procedures.--In carrying out this
subsection, the Secretary shall adapt any negotiated rulemaking
procedures to the unique context of the government-to-
government relationship between the United States and Indian
Tribes.
``(5) Effect.--The lack of promulgated regulations under this
subsection shall not limit the effect or implementation of this
section.
``(e) Application.--An entity desiring an award under subsection (b)
shall submit an application to the Secretary at such time, in such
manner, and accompanied by such information as the Secretary may
reasonably require.
``(f) Report.--Not later than 3 years after the date of the enactment
of the Restoring Hope for Mental Health and Well-Being Act of 2022, and
annually thereafter, the Secretary shall prepare and submit, to the
Committee on Health, Education, Labor, and Pensions of the Senate, and
the Committee on Energy and Commerce of the House of Representatives, a
report describing the services provided pursuant to this section.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $40,000,000 for each of fiscal
years 2023 through 2027.''.
Subtitle B--Summer Barrow Prevention, Treatment, and Recovery
SEC. 211. GRANTS FOR THE BENEFIT OF HOMELESS INDIVIDUALS.
Section 506(e) of the Public Health Service Act (42 U.S.C. 290aa-
5(e)) is amended by striking ``2018 through 2022'' and inserting ``2023
through 2027''.
SEC. 212. PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF REGIONAL AND
NATIONAL SIGNIFICANCE.
Section 509 of the Public Health Service Act (42 U.S.C. 290bb-2) is
amended--
(1) in the section heading, by striking ``abuse'' and
inserting ``use disorder'';
(2) in subsection (a)--
(A) by striking ``tribes and tribal organizations (as
the terms `Indian tribes' and `tribal organizations'
are defined'' and inserting ``Tribes and Tribal
organizations (as such terms are defined''; and
(B) in paragraph (3), by striking ``in substance
abuse'';
(3) in subsection (b), in the subsection heading, by striking
``Abuse'' and inserting ``Use Disorder''; and
(4) in subsection (f), by striking ``$333,806,000 for each of
fiscal years 2018 through 2022'' and inserting ``$521,517,000
for each of fiscal years 2023 through 2027''.
SEC. 213. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND
INTERVENTIONS DEMONSTRATION.
Section 514B of the Public Health Service Act (42 U.S.C. 290bb-10) is
amended--
(1) in subsection (a)(1)--
(A) by striking ``substance abuse'' and inserting
``substance use disorder'';
(B) by striking ``tribes and tribal organizations''
and inserting ``Tribes and Tribal organizations''; and
(C) by striking ``addiction'' and inserting
``substance use disorders'';
(2) in subsection (e)(3), by striking ``tribes and tribal
organizations'' and inserting ``Tribes and Tribal
organizations''; and
(3) in subsection (f), by striking ``2017 through 2021'' and
inserting ``2023 through 2027''.
SEC. 214. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF REGIONAL
AND NATIONAL SIGNIFICANCE.
Section 516 of the Public Health Service Act (42 U.S.C. 290bb-22) is
amended--
(1) in subsection (a)--
(A) in paragraph (3), by striking ``abuse'' and
inserting ``use''; and
(B) in the matter following paragraph (3), by
striking ``tribes or tribal organizations'' and
inserting ``Tribes or Tribal organizations'';
(2) in subsection (b), in the subsection heading, by striking
``Abuse'' and inserting ``Use Disorder''; and
(3) in subsection (f), by striking ``$211,148,000 for each of
fiscal years 2018 through 2022'' and inserting ``$218,219,000
for each of fiscal years 2023 through 2027''.
SEC. 215. SOBER TRUTH ON PREVENTING (STOP) UNDERAGE DRINKING
REAUTHORIZATION.
Section 519B of the Public Health Service Act (42 U.S.C. 290bb-25b)
is amended--
(1) by amending subsection (a) to read as follows:
``(a) Definitions.--For purposes of this section:
``(1) The term `alcohol beverage industry' means the brewers,
vintners, distillers, importers, distributors, and retail or
online outlets that sell or serve beer, wine, and distilled
spirits.
``(2) The term `school-based prevention' means programs,
which are institutionalized, and run by staff members or
school-designated persons or organizations in any grade of
school, kindergarten through 12th grade.
``(3) The term `youth' means persons under the age of 21.'';
and
(2) by striking subsections (c) through (g) and inserting the
following:
``(c) Interagency Coordinating Committee; Annual Report on State
Underage Drinking Prevention and Enforcement Activities.--
``(1) Interagency coordinating committee on the prevention of
underage drinking.--
``(A) In general.--The Secretary, in collaboration
with the Federal officials specified in subparagraph
(B), shall continue to support and enhance the efforts
of the interagency coordinating committee, that began
operating in 2004, focusing on underage drinking
(referred to in this subsection as the `Committee').
``(B) Other agencies.--The officials referred to in
subparagraph (A) are the Secretary of Education, the
Attorney General, the Secretary of Transportation, the
Secretary of the Treasury, the Secretary of Defense,
the Surgeon General, the Director of the Centers for
Disease Control and Prevention, the Director of the
National Institute on Alcohol Abuse and Alcoholism, the
Assistant Secretary for Mental Health and Substance
Use, the Director of the National Institute on Drug
Abuse, the Assistant Secretary for Children and
Families, the Director of the Office of National Drug
Control Policy, the Administrator of the National
Highway Traffic Safety Administration, the
Administrator of the Office of Juvenile Justice and
Delinquency Prevention, the Chairman of the Federal
Trade Commission, and such other Federal officials as
the Secretary of Health and Human Services determines
to be appropriate.
``(C) Chair.--The Secretary of Health and Human
Services shall serve as the chair of the Committee.
``(D) Duties.--The Committee shall guide policy and
program development across the Federal Government with
respect to underage drinking, provided, however, that
nothing in this section shall be construed as
transferring regulatory or program authority from an
Agency to the Coordinating Committee.
``(E) Consultations.--The Committee shall actively
seek the input of and shall consult with all
appropriate and interested parties, including States,
public health research and interest groups,
foundations, and alcohol beverage industry trade
associations and companies.
``(F) Annual report.--
``(i) In general.--The Secretary, on behalf
of the Committee, shall annually submit to the
Congress a report that summarizes--
``(I) all programs and policies of
Federal agencies designed to prevent
and reduce underage drinking, focusing
particularly on programs and policies
that support the adoption and
enforcement of State policies designed
to prevent and reduce underage drinking
as specified in paragraph (2);
``(II) the extent of progress in
preventing and reducing underage
drinking at State and national levels;
``(III) data that the Secretary shall
collect with respect to the information
specified in clause (ii); and
``(IV) such other information
regarding underage drinking as the
Secretary determines to be appropriate.
``(ii) Certain information.--The report under
clause (i) shall include information on the
following:
``(I) Patterns and consequences of
underage drinking as reported in
research and surveys such as, but not
limited to, Monitoring the Future,
Youth Risk Behavior Surveillance
System, the National Survey on Drug Use
and Health, and the Fatality Analysis
Reporting System.
``(II) Measures of the availability
of alcohol from commercial and non-
commercial sources to underage
populations.
``(III) Measures of the exposure of
underage populations to messages
regarding alcohol in advertising,
social media, and the entertainment
media.
``(IV) Surveillance data, including
information on the onset and prevalence
of underage drinking, consumption
patterns, beverage preferences,
prevalence of drinking among students
at institutions of higher education,
correlations between adult and youth
drinking, and the means of underage
access, including trends over time for
these surveillance data. The Secretary
shall develop a plan to improve the
collection, measurement, and
consistency of reporting Federal
underage alcohol data.
``(V) Any additional findings
resulting from research conducted or
supported under subsection (f).
``(VI) Evidence-based best practices
to prevent and reduce underage drinking
including a review of the research
literature related to State laws,
regulations, and policies designed to
prevent and reduce underage drinking,
as described in paragraph (2)(B)(i).
``(2) Annual report on state underage drinking prevention and
enforcement activities.--
``(A) In general.--The Secretary shall, with input
and collaboration from other appropriate Federal
agencies, States, Indian Tribes, territories, and
public health, consumer, and alcohol beverage industry
groups, annually issue a report on each State's
performance in enacting, enforcing, and creating laws,
regulations, and policies to prevent or reduce underage
drinking based on an assessment of best practices
developed pursuant to paragraph (1)(F)(ii)(VI) and
subparagraph (B)(i). For purposes of this paragraph,
each such report, with respect to a year, shall be
referred to as the `State Report'. Each State Report
shall be designed as a resource tool for Federal
agencies assisting States in the their underage
drinking prevention efforts, State public health and
law enforcement agencies, State and local policymakers,
and underage drinking prevention coalitions including
those receiving grants pursuant to subsection (e).
``(B) State performance measures.--
``(i) In general.--The Secretary shall
develop, in consultation with the Committee, a
set of measures to be used in preparing the
State Report on best practices as they relate
to State laws, regulations, policies, and
enforcement practices.
``(ii) State report content.--The State
Report shall include updates on State laws,
regulations, and policies included in previous
reports to Congress, including with respect to
the following:
``(I) Whether or not the State has
comprehensive anti-underage drinking
laws such as for the illegal sale,
purchase, attempt to purchase,
consumption, or possession of alcohol;
illegal use of fraudulent ID; illegal
furnishing or obtaining of alcohol for
an individual under 21 years; the
degree of strictness of the penalties
for such offenses; and the prevalence
of the enforcement of each of these
infractions.
``(II) Whether or not the State has
comprehensive liability statutes
pertaining to underage access to
alcohol such as dram shop, social host,
and house party laws, and the
prevalence of enforcement of each of
these laws.
``(III) Whether or not the State
encourages and conducts comprehensive
enforcement efforts to prevent underage
access to alcohol at retail outlets,
such as random compliance checks and
shoulder tap programs, and the number
of compliance checks within alcohol
retail outlets measured against the
number of total alcohol retail outlets
in each State, and the result of such
checks.
``(IV) Whether or not the State
encourages training on the proper
selling and serving of alcohol for all
sellers and servers of alcohol as a
condition of employment.
``(V) Whether or not the State has
policies and regulations with regard to
direct sales to consumers and home
delivery of alcoholic beverages.
``(VI) Whether or not the State has
programs or laws to deter adults from
purchasing alcohol for minors; and the
number of adults targeted by these
programs.
``(VII) Whether or not the State has
enacted graduated drivers licenses and
the extent of those provisions.
``(iii) Additional categories.--In addition
to the updates on State laws, regulations, and
policies listed in clause (ii), the Secretary
shall consider the following:
``(I) Whether or not States have
adopted laws, regulations, and policies
that deter underage alcohol use, as
described in `The Surgeon General's
Call to Action to Prevent and Reduce
Underage Drinking' issued in 2007 and
`Facing Addiction in America: The
Surgeon General's Report on Alcohol,
Drugs and Health' issued in 2016,
including restrictions on low-price,
high-volume drink specials, and
wholesaler pricing provisions.
``(II) Whether or not States have
adopted laws, regulations, and policies
designed to reduce alcohol advertising
messages attractive to youth and youth
exposure to alcohol advertising and
marketing in measured and unmeasured
media and digital and social media.
``(III) Whether or not States have
laws and policies that promote underage
drinking prevention policy development
by local jurisdictions.
``(IV) Whether or not States have
adopted laws, regulations, and policies
to restrict youth access to alcoholic
beverages that may pose special risks
to youth, including but not limited to
alcoholic mists, gelatins, freezer
pops, premixed caffeinated alcoholic
beverages, and flavored malt beverages.
``(V) Whether or not States have
adopted uniform best practices
protocols for conducting compliance
checks and shoulder tap programs.
``(VI) Whether or not States have
adopted uniform best practices penalty
protocols for violations of laws
prohibiting retail licensees from
selling or furnishing of alcohol to
minors.
``(iv) Uniform data system.--For performance
measures related to enforcement of underage
drinking laws as specified in clauses (ii) and
(iii), the Secretary shall develop and test a
uniform data system for reporting State
enforcement data, including the development of
a pilot program for this purpose. The pilot
program shall include procedures for collecting
enforcement data from both State and local law
enforcement jurisdictions.
``(3) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $1,000,000 for
each of fiscal years 2023 through 2027.
``(d) National Media Campaign To Prevent Underage Drinking.--
``(1) In general.--The Secretary, in consultation with the
National Highway Traffic Safety Administration, shall develop
an intensive, multifaceted, adult-oriented national media
campaign to reduce underage drinking by influencing attitudes
regarding underage drinking, increasing the willingness of
adults to take actions to reduce underage drinking, and
encouraging public policy changes known to decrease underage
drinking rates.
``(2) Purpose.--The purpose of the national media campaign
described in this section shall be to achieve the following
objectives:
``(A) Instill a broad societal commitment to reduce
underage drinking.
``(B) Increase specific actions by adults that are
meant to discourage or inhibit underage drinking.
``(C) Decrease adult conduct that tends to facilitate
or condone underage drinking.
``(3) Components.--When implementing the national media
campaign described in this section, the Secretary shall--
``(A) educate the public about the public health and
safety benefits of evidence-based policies to reduce
underage drinking, including minimum legal drinking age
laws, and build public and parental support for and
cooperation with enforcement of such policies;
``(B) educate the public about the negative
consequences of underage drinking;
``(C) promote specific actions by adults that are
meant to discourage or inhibit underage drinking,
including positive behavior modeling, general parental
monitoring, and consistent and appropriate discipline;
``(D) discourage adult conduct that tends to
facilitate underage drinking, including the hosting of
underage parties with alcohol and the purchasing of
alcoholic beverages on behalf of underage youth;
``(E) establish collaborative relationships with
local and national organizations and institutions to
further the goals of the campaign and assure that the
messages of the campaign are disseminated from a
variety of sources;
``(F) conduct the campaign through multi-media
sources; and
``(G) conduct the campaign with regard to changing
demographics and cultural and linguistic factors.
``(4) Consultation requirement.--In developing and
implementing the national media campaign described in this
section, the Secretary shall consult recommendations for
reducing underage drinking published by the National Academy of
Sciences and the Surgeon General. The Secretary shall also
consult with interested parties including medical, public
health, and consumer and parent groups, law enforcement,
institutions of higher education, community organizations and
coalitions, and other stakeholders supportive of the goals of
the campaign.
``(5) Annual report.--The Secretary shall produce an annual
report on the progress of the development or implementation of
the media campaign described in this subsection, including
expenses and projected costs, and, as such information is
available, report on the effectiveness of such campaign in
affecting adult attitudes toward underage drinking and adult
willingness to take actions to decrease underage drinking.
``(6) Research on youth-oriented campaign.--The Secretary
may, based on the availability of funds, conduct research on
the potential success of a youth-oriented national media
campaign to reduce underage drinking. The Secretary shall
report any such results to Congress with policy recommendations
on establishing such a campaign.
``(7) Administration.--The Secretary may enter into a
subcontract with another Federal agency to delegate the
authority for execution and administration of the adult-
oriented national media campaign.
``(8) Authorization of appropriations.--There is authorized
to be appropriated to carry out this section $2,500,000 for
each of fiscal years 2023 through 2027.
``(e) Community-Based Coalition Enhancement Grants To Prevent
Underage Drinking.--
``(1) Authorization of program.--The Assistant Secretary for
Mental Health and Substance Use, in consultation with the
Director of the Office of National Drug Control Policy, shall
award enhancement grants to eligible entities to design,
implement, evaluate, and disseminate comprehensive strategies
to maximize the effectiveness of community-wide approaches to
preventing and reducing underage drinking. This subsection is
subject to the availability of appropriations.
``(2) Purposes.--The purposes of this subsection are to--
``(A) prevent and reduce alcohol use among youth in
communities throughout the United States;
``(B) strengthen collaboration among communities, the
Federal Government, Tribal Governments, and State and
local governments;
``(C) enhance intergovernmental cooperation and
coordination on the issue of alcohol use among youth;
``(D) serve as a catalyst for increased citizen
participation and greater collaboration among all
sectors and organizations of a community that first
demonstrates a long-term commitment to reducing alcohol
use among youth;
``(E) implement state-of-the-art science-based
strategies to prevent and reduce underage drinking by
changing local conditions in communities; and
``(F) enhance, not supplant, effective local
community initiatives for preventing and reducing
alcohol use among youth.
``(3) Application.--An eligible entity desiring an
enhancement grant under this subsection shall submit an
application to the Assistant Secretary at such time, and in
such manner, and accompanied by such information and
assurances, as the Assistant Secretary may require. Each
application shall include--
``(A) a complete description of the entity's current
underage alcohol use prevention initiatives and how the
grant will appropriately enhance the focus on underage
drinking issues; or
``(B) a complete description of the entity's current
initiatives, and how it will use this grant to enhance
those initiatives by adding a focus on underage
drinking prevention.
``(4) Uses of funds.--Each eligible entity that receives a
grant under this subsection shall use the grant funds to carry
out the activities described in such entity's application
submitted pursuant to paragraph (3) and obtain specialized
training and technical assistance by the entity funded under
section 4 of Public Law 107-82, as amended (21 U.S.C. 1521
note). Grants under this subsection shall not exceed $60,000
per year and may not exceed four years.
``(5) Supplement not supplant.--Grant funds provided under
this subsection shall be used to supplement, not supplant,
Federal and non-Federal funds available for carrying out the
activities described in this subsection.
``(6) Evaluation.--Grants under this subsection shall be
subject to the same evaluation requirements and procedures as
the evaluation requirements and procedures imposed on
recipients of drug-free community grants.
``(7) Definitions.--For purposes of this subsection, the term
`eligible entity' means an organization that is currently
receiving or has received grant funds under the Drug-Free
Communities Act of 1997.
``(8) Administrative expenses.--Not more than 6 percent of a
grant under this subsection may be expended for administrative
expenses.
``(9) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $11,500,000 for
each of fiscal years 2023 through 2027.
``(f) Grants to Professional Pediatric Provider Organizations To
Reduce Underage Drinking Through Screening and Brief Interventions.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary for Mental Health and Substance Use, shall
make one or more grants to professional pediatric provider
organizations to increase among the members of such
organizations effective practices to reduce the prevalence of
alcohol use among individuals under the age of 21, including
college students.
``(2) Purposes.--Grants under this subsection shall be made
to promote the practices of--
``(A) screening adolescents for alcohol use;
``(B) offering brief interventions to adolescents to
discourage such use;
``(C) educating parents about the dangers of and
methods of discouraging such use;
``(D) diagnosing and treating alcohol use disorders;
and
``(E) referring patients, when necessary, to other
appropriate care.
``(3) Use of funds.--A professional pediatric provider
organization receiving a grant under this section may use the
grant funding to promote the practices specified in paragraph
(2) among its members by--
``(A) providing training to health care providers;
``(B) disseminating best practices, including
culturally and linguistically appropriate best
practices, and developing, printing, and distributing
materials; and
``(C) supporting other activities approved by the
Assistant Secretary.
``(4) Application.--To be eligible to receive a grant under
this subsection, a professional pediatric provider organization
shall submit an application to the Assistant Secretary at such
time, and in such manner, and accompanied by such information
and assurances as the Secretary may require. Each application
shall include--
``(A) a description of the pediatric provider
organization;
``(B) a description of the activities to be completed
that will promote the practices specified in paragraph
(2);
``(C) a description of the organization's
qualifications for performing such practices; and
``(D) a timeline for the completion of such
activities.
``(5) Definitions.--For the purpose of this subsection:
``(A) Brief intervention.--The term `brief
intervention' means, after screening a patient,
providing the patient with brief advice and other brief
motivational enhancement techniques designed to
increase the insight of the patient regarding the
patient's alcohol use, and any realized or potential
consequences of such use to effect the desired related
behavioral change.
``(B) Adolescents.--The term `adolescents' means
individuals under 21 years of age.
``(C) Professional pediatric provider organization.--
The term `professional pediatric provider organization'
means an organization or association that--
``(i) consists of or represents pediatric
health care providers; and
``(ii) is qualified to promote the practices
specified in paragraph (2).
``(D) Screening.--The term `screening' means using
validated patient interview techniques to identify and
assess the existence and extent of alcohol use in a
patient.
``(6) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $3,000,000 for
each of fiscal years 2023 through 2027.
``(g) Data Collection and Research.--
``(1) Additional research on underage drinking.--
``(A) In general.--The Secretary shall, subject to
the availability of appropriations, collect data, and
conduct or support research that is not duplicative of
research currently being conducted or supported by the
Department of Health and Human Services, on underage
drinking, with respect to the following:
``(i) Improve data collection in support of
evaluation of the effectiveness of
comprehensive community-based programs or
strategies and statewide systems to prevent and
reduce underage drinking, across the underage
years from early childhood to age 21, such as
programs funded and implemented by governmental
entities, public health interest groups and
foundations, and alcohol beverage companies and
trade associations, through the development of
models of State-level epidemiological
surveillance of underage drinking by funding in
States or large metropolitan areas new
epidemiologists focused on excessive drinking
including underage alcohol use.
``(ii) Obtain and report more precise
information than is currently collected on the
scope of the underage drinking problem and
patterns of underage alcohol consumption,
including improved knowledge about the problem
and progress in preventing, reducing, and
treating underage drinking, as well as
information on the rate of exposure of youth to
advertising and other media messages
encouraging and discouraging alcohol
consumption.
``(iii) Synthesize, expand on, and widely
disseminate existing research on effective
strategies for reducing underage drinking,
including translational research, and make this
research easily accessible to the general
public.
``(iv) Improve and conduct public health
surveillance on alcohol use and alcohol-related
conditions in States by increasing the use of
surveys, such as the Behavioral Risk Factor
Surveillance System, to monitor binge and
excessive drinking and related harms among
individuals who are at least 18 years of age,
but not more than 20 years of age, including
harm caused to self or others as a result of
alcohol use that is not duplicative of research
currently being conducted or supported by the
Department of Health and Human Services.
``(B) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
paragraph $5,000,000 for each of fiscal years 2023
through 2027.
``(2) National academy of sciences study.--
``(A) In general.--Not later than 12 months after the
enactment of the Restoring Hope for Mental Health and
Well-Being Act of 2022, the Secretary shall--
``(i) contract with the National Academy of
Sciences to study developments in research on
underage drinking and the public policy
implications of these developments; and
``(ii) report to the Congress on the results
of such review.
``(B) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
paragraph $500,000 for fiscal year 2023.''.
SEC. 216. GRANTS FOR JAIL DIVERSION PROGRAMS.
Section 520G of the Public Health Service Act (42 U.S.C. 290bb-38) is
amended--
(1) in subsection (a)--
(A) by striking ``up to 125''; and
(B) by striking ``tribes and tribal organizations''
and inserting ``Tribes and Tribal organizations'';
(2) in subsection (b)(2), by striking ``tribes, and tribal
organizations'' and inserting ``Tribes, and Tribal
organizations'';
(3) in subsection (c)--
(A) in paragraph (1), by striking ``tribe or tribal
organization'' and inserting ``Tribe or Tribal
organization, health facility or program described in
subsection (a), or public or nonprofit entity referred
to in subsection (a)''; and
(B) in paragraph (2)(A)(iii), by striking ``tribe, or
tribal organization'' and inserting ``Tribe, or Tribal
organization'';
(4) in subsection (e)--
(A) in the matter preceding paragraph (1), by
striking ``tribe, or tribal organization'' and
inserting ``Tribe, or Tribal organization''; and
(B) in paragraph (5), by striking ``or arrest'' and
inserting ``, arrest, or release'';
(5) in subsection (f), by striking ``tribe, or tribal
organization'' each place it appears and inserting ``Tribe, or
Tribal organization'';
(6) in subsection (h), by striking ``tribe, or tribal
organization'' and inserting ``Tribe, or Tribal organization'';
and
(7) in subsection (j), by striking ``$4,269,000 for each of
fiscal years 2018 through 2022'' and inserting ``$14,000,000
for each of fiscal years 2023 through 2027''.
SEC. 217. FORMULA GRANTS TO STATES.
Section 521 of the Public Health Service Act (42 U.S.C. 290cc-21) is
amended by striking ``2018 through 2022'' and inserting ``2023 through
2027''.
SEC. 218. PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS.
Section 535(a) of the Public Health Service Act (42 U.S.C. 290cc-
35(a)) is amended by striking ``2018 through 2022'' and inserting
``2023 through 2027''.
SEC. 219. GRANTS FOR REDUCING OVERDOSE DEATHS.
(a) Grants.--
(1) Repeal of maximum grant amount.--Paragraph (2) of section
544(a) of the Public Health Service Act (42 U.S.C. 290dd-3(a))
is hereby repealed.
(2) Eligible entity; subgrants.--Section 544(a) of the Public
Health Service Act (42 U.S.C. 290dd-3(a)) is amended by
striking paragraph (3) and inserting the following:
``(2) Eligible entity.--For purposes of this section, the
term `eligible entity' means a State, Territory, locality,
Indian Tribe (as defined in the Federally Recognized Indian
Tribe List Act of 1994), Tribal organization, or Urban Indian
organization (as those terms are defined in section 4 of the
Indian Health Care Improvement Act).
``(3) Subgrants.--For the purposes for which a grant is
awarded under this section, the eligible entity receiving the
grant may award subgrants to a Federally qualified health
center (as defined in section 1861(aa) of the Social Security
Act), an opioid treatment program (as defined in section 8.2 of
title 42, Code of Federal Regulations (or any successor
regulations)), any practitioner dispensing narcotic drugs
pursuant to section 303(g) of the Controlled Substances Act, or
any nonprofit organization that the Secretary deems
appropriate.''.
(3) Prescribing.--Section 544(a)(4) of the Public Health
Service Act (42 U.S.C. 290dd-3(a)(4)) is amended--
(A) in subparagraph (A), by inserting ``, including
patients prescribed with both an opioid and a
benzodiazepine'' before the semicolon at the end; and
(B) in subparagraph (D), by striking ``drug
overdose'' and inserting ``substance overdose''.
(4) Use of funds.--Paragraph (5) of section 544(c) of the
Public Health Service Act (42 U.S.C. 290dd-3(c)) is amended to
read as follows:
``(5) To establish protocols to connect patients who have
experienced an overdose with appropriate treatment, including
overdose reversal medications, medication assisted treatment,
and appropriate counseling and behavioral therapies.''.
(5) Improving access to overdose treatment.--Section 544 of
the Public Health Service Act (42 U.S.C. 290dd-3) is amended--
(A) by redesignating subsections (d) through (f) as
subsections (e) through (g), respectively;
(B) in subsection (f), as so redesignated, by
striking ``subsection (d)'' and inserting ``subsection
(e)''; and
(C) by inserting after subsection (c) the following:
``(d) Improving Access to Overdose Treatment.--
``(1) Information on best practices.--
``(A) Health and human services.--The Secretary of
Health and Human Services may provide information to
States, localities, Indian Tribes, Tribal
organizations, and Urban Indian organizations on best
practices for prescribing or co-prescribing a drug or
device approved, cleared, or otherwise authorized under
the Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose,
including for patients receiving chronic opioid therapy
and patients being treated for opioid use disorders.
``(B) Defense.--The Secretary of Defense may provide
information to prescribers within Department of Defense
medical facilities on best practices for prescribing or
co-prescribing a drug or device approved, cleared, or
otherwise authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose, including for patients
receiving chronic opioid therapy and patients being
treated for opioid use disorders.
``(C) Veterans affairs.--The Secretary of Veterans
Affairs may provide information to prescribers within
Department of Veterans Affairs medical facilities on
best practices for prescribing or co-prescribing a drug
or device approved, cleared, or otherwise authorized
under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid
overdose, including for patients receiving chronic
opioid therapy and patients being treated for opioid
use disorders.
``(2) Rule of construction.--Nothing in this subsection shall
be construed as establishing or contributing to a medical
standard of care.''.
(6) Authorization of appropriations.--Section 544(g) of the
Public Health Service Act (42 U.S.C. 290dd-3), as redesignated,
is amended by striking ``fiscal years 2017 through 2021'' and
inserting ``fiscal years 2023 through 2027''.
(7) Technical amendments.--
(A) Section 544 of the Public Health Service Act (42
U.S.C. 290dd-3), as amended, is further amended by
striking ``approved or cleared'' each place it appears
and inserting ``approved, cleared, or otherwise
authorized''.
(B) Section 107 of the Comprehensive Addiction and
Recovery Act of 2016 (Public Law 114-198) is amended by
striking subsection (b).
SEC. 220. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION
GRANT PROGRAMS.
(a) Grants.--Section 545 of the Public Health Service Act (42 U.S.C.
290ee) is amended--
(1) in the section heading, by striking ``access and
education grant programs'' and inserting ``access, education,
and co-prescribing grant programs'';
(2) in the heading of subsection (a), by striking ``Grants to
States'' and inserting ``Grants'';
(3) in subsection (a), by striking ``shall make grants to
States'' and inserting ``shall make grants to States,
localities, Indian Tribes (as defined by the Federally
Recognized Indian Tribe List Act of 1994), Tribal
organizations, and Urban Indian organizations (as those terms
are defined in section 4 of the Indian Health Care Improvement
Act)'';
(4) in subsection (a)(1), by striking ``implement strategies
for pharmacists to dispense a drug or device'' and inserting
``implement strategies that increase access to drugs or
devices'';
(5) by redesignating paragraphs (3) and (4) as paragraphs (4)
and (5), respectively; and
(6) by inserting after paragraph (2) the following:
``(3) encourage health care providers to co-prescribe, as
appropriate, drugs or devices approved, cleared, or otherwise
authorized under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid overdose;''.
(b) Grant Period.--Section 545(d)(2) of the Public Health Service Act
(42 U.S.C. 290ee(d)(2)) is amended by striking ``3 years'' and
inserting ``5 years''.
(c) Limitation.--Paragraph (3) of section 545(d) of the Public Health
Service Act (42 U.S.C. 290ee(d)) is amended to read as follows:
``(3) Limitations.--A State may--
``(A) use not more than 10 percent of a grant under
this section for educating the public pursuant to
subsection (a)(5); and
``(B) use not less than 20 percent of a grant under
this section to offset cost-sharing for distribution
and dispensing of drugs or devices approved, cleared,
or otherwise authorized under the Federal Food, Drug,
and Cosmetic Act for emergency treatment of known or
suspected opioid overdose.''.
(d) Authorization of Appropriations.--Section 545(h)(1) of the Public
Health Service Act, is amended by striking ``fiscal years 2017 through
2019'' and inserting ``fiscal years 2023 through 2027''.
(e) Technical Amendment.--Section 545 of the Public Health Service
Act (42 U.S.C. 290ee), as amended, is further amended by striking
``approved or cleared'' each place it appears and inserting ``approved,
cleared, or otherwise authorized''.
SEC. 221. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE OPIOID ABUSE
RESPONSE.
Section 548 of the Public Health Service Act (42 U.S.C. 290ee-3) is
amended--
(1) in the section heading, by striking ``abuse'' and
inserting ``use disorder'';
(2) in subsection (b)--
(A) in the subsection heading, by striking ``Abuse''
and inserting ``Use Disorder'';
(B) in paragraph (1), by striking ``abuse'' and
inserting ``use disorder'';
(C) in paragraph (2)--
(i) in the matter preceding subparagraph (A),
by striking ``abuse'' and inserting ``use
disorder'';
(ii) in subparagraph (A), by striking
``opioid use, treatment, and addiction
recovery'' and inserting ``opioid use
disorders, and treatment for, and recovery from
opioid use disorders'';
(iii) in subparagraph (C), by striking
``addiction'' each place it appears and
inserting ``use disorder'';
(iv) by amending subparagraph (D) to read as
follows:
``(D) developing, implementing, and expanding efforts
to prevent overdose death from opioid or other
prescription medication use disorders; and''; and
(v) in subparagraph (E), by striking
``abuse'' and inserting ``use disorders''; and
(D) in paragraph (4), by striking ``abuse'' each
place it appears and inserting ``use disorders''; and
(3) by striking ``2017 through 2021'' and inserting ``2023
through 2027''.
SEC. 222. EMERGENCY DEPARTMENT ALTERNATIVES TO OPIOIDS.
Section 7091 of the SUPPORT for Patients and Communities Act (Public
Law 115-271) is amended--
(1) in the section heading, by striking ``demonstration''
(and by conforming the item relating to such section in the
table of contents in section 1(b));
(2) in subsection (a)--
(A) by amending the subsection heading to read as
follows: ``Grant Program''; and
(B) in paragraph (1), by striking ``demonstration'';
(3) in subsection (b), in the subsection heading, by striking
``Demonstration'';
(4) in subsection (d)(4), by striking ``tribal'' and
inserting ``Tribal'';
(5) in subsection (f), by striking ``Not later than 1 year
after completion of the demonstration program under this
section, the Secretary shall submit a report to the Congress on
the results of the demonstration program'' and inserting ``Not
later than the end of each of fiscal years 2024 and 2027, the
Secretary shall submit to the Congress a report on the results
of the program''; and
(6) in subsection (g), by striking ``2019 through 2021'' and
inserting ``2023 through 2027''.
Subtitle C--Excellence in Recovery Housing
SEC. 231. CLARIFYING THE ROLE OF SAMHSA IN PROMOTING THE AVAILABILITY
OF HIGH-QUALITY RECOVERY HOUSING.
Section 501(d) of the Public Health Service Act (42 U.S.C. 290aa) is
amended--
(1) in paragraph (24)(E), by striking ``and'' at the end;
(2) in paragraph (25), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(26) collaborate with national accrediting entities,
reputable providers, organizations or individuals with
established expertise in delivery of recovery housing services,
States, Federal agencies (including the Department of Health
and Human Services, the Department of Housing and Urban
Development, and the agencies listed in section 550(e)(2)(B)),
and other relevant stakeholders, to promote the availability of
high-quality recovery housing and services for individuals with
a substance use disorder.''.
SEC. 232. DEVELOPING GUIDELINES FOR STATES TO PROMOTE THE AVAILABILITY
OF HIGH-QUALITY RECOVERY HOUSING.
Section 550(a) of the Public Health Service Act (42 U.S.C. 290ee-
5(a)) (relating to national recovery housing best practices) is
amended--
(1) by amending paragraph (1) to read as follows:
``(1) In general.--The Secretary, in consultation with the
individuals and entities specified in paragraph (2), shall
build on existing best practices and previously developed
guidelines to develop and periodically update consensus-based
best practices, which may include model laws for implementing
suggested minimum standards for operating, and promoting the
availability of, high-quality recovery housing.'';
(2) in paragraph (2)--
(A) by striking subparagraphs (A) and (B) and
inserting the following:
``(A) Officials representing the agencies described
in subsection (e)(2).''; and
(B) by redesignating subparagraphs (C) through (G) as
subparagraphs (B) through (F), respectively; and
(3) by adding at the end the following:
``(3) Availability.--The best practices referred to in
paragraph (1) shall be--
``(A) made publicly available; and
``(B) published on the public website of the
Substance Abuse and Mental Health Services
Administration.
``(4) Exclusion of guideline on treatment services.--In
developing the guidelines under paragraph (1), the Secretary
may not include any guidelines with respect to substance use
disorder treatment services.''.
SEC. 233. COORDINATION OF FEDERAL ACTIVITIES TO PROMOTE THE
AVAILABILITY OF RECOVERY HOUSING.
Section 550 of the Public Health Service Act (42 U.S.C. 290ee-5)
(relating to national recovery housing best practices) is amended--
(1) by redesignating subsections (e), (f), and (g) as
subsections (g), (h), and (i), respectively; and
(2) by inserting after subsection (d) the following:
``(e) Coordination of Federal Activities To Promote the Availability
of Housing for Individuals Experiencing Homelessness, Individuals With
a Mental Illness, and Individuals With a Substance Use Disorder.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary, and the Secretary of Housing and Urban
Development shall convene an interagency working group for the
following purposes:
``(A) To increase collaboration, cooperation, and
consultation among the Department of Health and Human
Services, the Department of Housing and Urban
Development, and the Federal agencies listed in
paragraph (2)(B), with respect to promoting the
availability of housing, including recovery housing,
for individuals experiencing homelessness, individuals
with mental illnesses, and individuals with substance
use disorder.
``(B) To align the efforts of such agencies and avoid
duplication of such efforts by such agencies.
``(C) To develop objectives, priorities, and a long-
term plan for supporting State, Tribal, and local
efforts with respect to the operation of recovery
housing that is consistent with the best practices
developed under this section.
``(D) To coordinate enforcement of fair housing
practices, as appropriate, among Federal and State
agencies.
``(E) To coordinate data collection on the quality of
recovery housing.
``(2) Composition.--The interagency working group under
paragraph (1) shall be composed of--
``(A) the Secretary, acting through the Assistant
Secretary, and the Secretary of Housing and Urban
Development, who shall serve as the co-chairs; and
``(B) representatives of each of the following
Federal agencies:
``(i) The Centers for Medicare & Medicaid
Services.
``(ii) The Substance Abuse and Mental Health
Services Administration.
``(iii) The Health Resources and Services
Administration.
``(iv) The Office of Inspector General.
``(v) The Indian Health Service.
``(vi) The Department of Agriculture.
``(vii) The Department of Justice.
``(viii) The Office of National Drug Control
Policy.
``(ix) The Bureau of Indian Affairs.
``(x) The Department of Labor.
``(xi) The Department of Veterans Affairs.
``(xii) Any other Federal agency as the co-
chairs determine appropriate.
``(3) Meetings.--The working group shall meet on a quarterly
basis.
``(4) Reports to congress.--Not later than 4 years after the
date of the enactment of this section, the working group shall
submit to the Committee on Energy and Commerce, the Committee
on Ways and Means, the Committee on Agriculture, and the
Committee on Financial Services of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions,
the Committee on Agriculture, Nutrition, and Forestry, and the
Committee on Finance of the Senate a report describing the work
of the working group and any recommendations of the working
group to improve Federal, State, and local coordination with
respect to recovery housing and other housing resources and
operations for individuals experiencing homelessness,
individuals with a mental illness, and individuals with a
substance use disorder.''.
SEC. 234. NAS STUDY AND REPORT.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Assistant Secretary for Mental Health and Substance Use shall--
(1) contract with the National Academies of Sciences,
Engineering, and Medicine--
(A) to study the quality and effectiveness of
recovery housing in the United States and whether the
availability of such housing meets demand; and
(B) to identify recommendations to promote the
availability of high-quality recovery housing; and
(2) report to the Congress on the results of such review.
(b) Authorization of Appropriations.--To carry out this section there
is authorized to be appropriated $1,500,000 for fiscal year 2023.
SEC. 235. GRANTS FOR STATES TO PROMOTE THE AVAILABILITY OF RECOVERY
HOUSING AND SERVICES.
Section 550 of the Public Health Service Act (42 U.S.C. 290ee-5)
(relating to national recovery housing best practices), as amended by
sections 232 and 233, is further amended by inserting after subsection
(e) (as inserted by section 233) the following:
``(f) Grants for Implementing National Recovery Housing Best
Practices.--
``(1) In general.--The Secretary shall award grants to States
(and political subdivisions thereof), Tribes, and territories--
``(A) for the provision of technical assistance to
implement the guidelines and recommendations developed
under subsection (a); and
``(B) to promote--
``(i) the availability of recovery housing
for individuals with a substance use disorder;
and
``(ii) the maintenance of recovery housing in
accordance with best practices developed under
this section.
``(2) State promotion plans.--Not later than 90 days after
receipt of a grant under paragraph (1), and every 2 years
thereafter, each State (or political subdivisions thereof,)
Tribe, or territory receiving a grant under paragraph (1) shall
submit to the Secretary, and publish on a publicly accessible
internet website of the State (or political subdivisions
thereof), Tribe, or territory--
``(A) the plan of the State (or political
subdivisions thereof), Tribe, or territory, with
respect to the promotion of recovery housing for
individuals with a substance use disorder located
within the jurisdiction of such State (or political
subdivisions thereof), Tribe, or territory; and
``(B) a description of how such plan is consistent
with the best practices developed under this
section.''.
SEC. 236. FUNDING.
Subsection (i) of section 550 of the Public Health Service Act (42
U.S.C. 290ee-5) (relating to national recovery housing best practices),
as redesignated by section 233, is amended by striking ``$3,000,000 for
the period of fiscal years 2019 through 2021'' and inserting
``$5,000,000 for the period of fiscal years 2023 through 2027''.
SEC. 237. TECHNICAL CORRECTION.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is
amended--
(1) by redesignating section 550 (relating to Sobriety
Treatment and Recovery Teams) (42 U.S.C. 290ee-10), as added by
section 8214 of Public Law 115-271, as section 550A; and
(2) by moving such section so it appears after section 550
(relating to national recovery housing best practices).
Subtitle D--Substance Use Prevention, Treatment, and Recovery Services
Block Grant
SEC. 241. ELIMINATING STIGMATIZING LANGUAGE RELATING TO SUBSTANCE USE.
(a) Block Grants for Prevention and Treatment of Substance Use.--Part
B of title XIX of the Public Health Service Act (42 U.S.C. 300x et
seq.) is amended--
(1) in the part heading, by striking ``substance abuse'' and
inserting ``substance use'';
(2) in subpart II, by amending the subpart heading to read as
follows: ``Block Grants for Substance Use Prevention,
Treatment, and Recovery Services'';
(3) in section 1922(a) (42 U.S.C. 300x-22(a))--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``substance abuse'' and
inserting ``substance use disorders''; and
(B) by striking ``such abuse'' each place it appears
in paragraphs (1) and (2) and inserting ``such
disorders'';
(4) in section 1923 (42 U.S.C. 300x-23)--
(A) in the section heading, by striking ``substance
abuse'' and inserting ``substance use''; and
(B) in subsection (a), by striking ``drug abuse'' and
inserting ``substance use disorders'';
(5) in section 1925(a)(1) (42 U.S.C. 300x-25(a)(1)), by
striking ``alcohol or drug abuse'' and inserting ``alcohol or
other substance use disorders'';
(6) in section 1926(b)(2)(B) (42 U.S.C. 300x-26(b)(2)(B)), by
striking ``substance abuse'';
(7) in section 1931(b)(2) (42 U.S.C. 300x-31(b)(2)), by
striking ``substance abuse'' and inserting ``substance use
disorders'';
(8) in section 1933(d)(1) (42 U.S.C. 300x-33(d)), in the
matter following subparagraph (B), by striking ``abuse of
alcohol and other drugs'' and inserting ``use of substances'';
(9) by amending paragraph (4) of section 1934 (42 U.S.C.
300x-34) to read as follows:
``(4) The term `substance use disorder' means the recurrent
use of alcohol or other drugs that causes clinically
significant impairment.'';
(10) in section 1935 (42 U.S.C. 300x-35)--
(A) in subsection (a), by striking ``substance
abuse'' and inserting ``substance use disorders''; and
(B) in subsection (b)(1), by striking ``substance
abuse'' each place it appears and inserting ``substance
use disorders'';
(11) in section 1949 (42 U.S.C. 300x-59), by striking
``substance abuse'' each place it appears in subsections (a)
and (d) and inserting ``substance use disorders'';
(12) in section 1954(b)(4) (42 U.S.C. 300x-64(b)(4))--
(A) by striking ``substance abuse'' and inserting
``substance use disorders''; and
(B) by striking ``such abuse'' and inserting ``such
disorders'';
(13) in section 1955 (42 U.S.C. 300x-65), by striking
``substance abuse'' each place it appears and inserting
``substance use disorder''; and
(14) in section 1956 (42 U.S.C. 300x-66), by striking
``substance abuse'' and inserting ``substance use disorders''.
(b) Certain Programs Regarding Mental Health and Substance Abuse.--
Part C of title XIX of the Public Health Service Act (42 U.S.C. 300y et
seq.) is amended--
(1) in the part heading, by striking ``substance abuse'' and
inserting ``substance use'';
(2) in section 1971 (42 U.S.C. 300y), by striking ``substance
abuse'' each place it appears in subsections (a), (b), and (f)
and inserting ``substance use''; and
(3) in section 1976 (42 U.S.C. 300y-11), by striking
``intravenous abuse'' each place it appears and inserting
``intravenous use''.
SEC. 242. AUTHORIZED ACTIVITIES.
Section 1921(b) of the Public Health Service Act (42 U.S.C. 300x-
21(b)) is amended by striking ``prevent and treat substance use
disorders'' and inserting ``prevent, treat, and provide recovery
support services for substance use disorders''.
SEC. 243. REQUIREMENTS RELATING TO CERTAIN INFECTIOUS DISEASES AND
HUMAN IMMUNODEFICIENCY VIRUS.
Section 1924 of the Public Health Service Act (42 U.S.C. 300x-24) is
amended--
(1) in the section heading, by striking ``tuberculosis and
human immunodeficiency virus'' and inserting ``tuberculosis,
viral hepatitis, and human immunodeficiency virus'';
(2) by amending subsection (a)(2) to read as follows:
``(2) Designated states.--
``(A) Fiscal years through fiscal year 2024.--For
purposes of this subsection, through September 30,
2024, a State described in this paragraph is any State
whose rate of cases of acquired immune deficiency
syndrome is 10 or more such cases per 100,000
individuals (as indicated by the number of such cases
reported to and confirmed by the Director of the
Centers for Disease Control and Prevention for the most
recent calendar year for which such data are
available).
``(B) Fiscal year 2025 and succeeding fiscal years.--
``(i) In general.--Beginning with fiscal year
2025, for purposes of this subsection, a State
described in this paragraph is any State whose
rate of cases of human immunodeficiency virus
is 10 or more such cases per 100,000
individuals (as indicated by the number of such
cases newly reported to and confirmed by the
Director of the Centers for Disease Control and
Prevention for the most recent calendar year
for which such data are available).
``(ii) Continuation of designated state
status.--In the case of a State whose rate of
cases of human immunodeficiency virus falls
below the threshold specified in clause (i) for
a calendar year, such State shall,
notwithstanding clause (i), continue to be
described in this paragraph unless the rate of
cases falls below such threshold for three
consecutive calendar years.''.
(3) by redesignating subsections (c) and (d) as subsections
(d) and (e), respectively; and
(4) by inserting after subsection (b) the following:
``(c) Viral Hepatitis.--
``(1) In general.--A funding agreement for a grant under
section 1921 is that the State involved will require that any
entity receiving amounts from the grant for operating a program
of treatment for substance use disorders--
``(A) will, directly or through arrangements with
other public or nonprofit private entities, routinely
make available viral hepatitis services to each
individual receiving treatment for such disorders; and
``(B) in the case of an individual in need of such
treatment who is denied admission to the program on the
basis of the lack of the capacity of the program to
admit the individual, will refer the individual to
another provider of viral hepatitis services.
``(2) Viral hepatitis services.--For purposes of paragraph
(1), the term `viral hepatitis services', with respect to an
individual, means--
``(A) screening the individual for viral hepatitis;
and
``(B) referring the individual to a provider whose
practice includes viral hepatitis vaccination and
treatment.''.
SEC. 244. STATE PLAN REQUIREMENTS.
Section 1932(b)(1)(A) of the Public Health Service Act (42 U.S.C.
300x-32(b)(1)(A)) is amended--
(1) by redesignating clauses (vi) through (ix) as clauses
(vii) through (x), respectively; and
(2) by inserting after clause (v) the following:
``(vi) provides a description of--
``(I) the State's comprehensive
statewide recovery support services
activities, including the number of
individuals being served, target
populations, and priority needs; and
``(II) the amount of funds received
under this subpart expended on recovery
support services, disaggregated by the
amount expended for type of service
activity;''.
SEC. 245. UPDATING CERTAIN LANGUAGE RELATING TO TRIBES.
Section 1933(d) of the Public Health Service Act (42 U.S.C. 300x-
33(d)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``of an Indian tribe or
tribal organization'' and inserting ``of an
Indian Tribe or Tribal organization''; and
(ii) by striking ``such tribe'' and inserting
``such Tribe'';
(B) in subparagraph (B)--
(i) by striking ``tribe or tribal
organization'' and inserting ``Tribe or Tribal
organization''; and
(ii) by striking ``Secretary under this'' and
inserting ``Secretary under this subpart''; and
(C) in the matter following subparagraph (B), by
striking ``tribe or tribal organization'' and inserting
``Tribe or Tribal organization'';
(2) by amending paragraph (2) to read as follows:
``(2) Indian tribe or tribal organization as grantee.--The
amount reserved by the Secretary on the basis of a
determination under this subsection shall be granted to the
Indian Tribe or Tribal organization serving the individuals for
whom such a determination has been made.'';
(3) in paragraph (3), by striking ``tribe or tribal
organization'' and inserting ``Tribe or Tribal organization'';
and
(4) in paragraph (4)--
(A) in the paragraph heading, by striking
``Definition'' and inserting ``Definitions''; and
(B) by striking ``The terms'' and all that follows
through ``given such terms'' and inserting the
following: ``The terms `Indian Tribe' and `Tribal
organization' have the meanings given the terms `Indian
tribe' and `tribal organization'''.
SEC. 246. BLOCK GRANTS FOR SUBSTANCE USE PREVENTION, TREATMENT, AND
RECOVERY SERVICES.
(a) In General.--Section 1935(a) of the Public Health Service Act (42
U.S.C. 300x-35(a)), as amended by section 241, is further amended by
striking ``appropriated'' and all that follows through ``2022..'' and
inserting the following: ``appropriated $1,908,079,000 for each of
fiscal years 2023 through 2027.''.
(b) Technical Corrections.--Section 1935(b)(1)(B) of the Public
Health Service Act (42 U.S.C. 300x-35(b)(1)(B)) is amended by striking
``the collection of data in this paragraph is''.
SEC. 247. REQUIREMENT OF REPORTS AND AUDITS BY STATES.
Section 1942(a) of the Public Health Service Act (42 U.S.C. 300x-
52(a)) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(3) the amount provided to each recipient in the previous
fiscal year.''.
SEC. 248. STUDY ON ASSESSMENT FOR USE IN DISTRIBUTION OF LIMITED STATE
RESOURCES.
(a) In General.--The Secretary of Health and Human Services, acting
through the Assistant Secretary for Mental Health and Substance Use (in
this section referred to as the ``Secretary''), shall, in consultation
with States and other local entities providing prevention, treatment,
or recovery support services related to substance use, conduct a study
to develop a model needs assessment process for States to consider to
help determine how best to allocate block grant funding received under
subpart II of part B of title XIX of the Public Health Service Act (42
U.S.C. 300x-21) to provide services to substance use disorder
prevention, treatment, and recovery support. The study shall include
cost estimates with each model needs assessment process.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the results of
the study conducted under paragraph (1).
Subtitle E--Timely Treatment for Opioid Use Disorder
SEC. 251. STUDY ON EXEMPTIONS FOR TREATMENT OF OPIOID USE DISORDER
THROUGH OPIOID TREATMENT PROGRAMS DURING THE COVID-
19 PUBLIC HEALTH EMERGENCY.
(a) Study.--The Assistant Secretary for Mental Health and Substance
Use shall conduct a study, in consultation with patients and other
stakeholders, on activities carried out pursuant to exemptions
granted--
(1) to a State (including the District of Columbia or any
territory of the United States) or an opioid treatment program;
(2) pursuant to section 8.11(h) of title 42, Code of Federal
Regulations; and
(3) during the period--
(A) beginning on the declaration of the public health
emergency for the COVID-19 pandemic under section 319
of the Public Health Service Act (42 U.S.C. 247d); and
(B) ending on the earlier of--
(i) the termination of such public health
emergency, including extensions thereof
pursuant to such section 319; and
(ii) the end of calendar year 2022.
(b) Privacy.--The section does not authorize the disclosure by the
Department of Health and Human Services of individually identifiable
information about patients.
(c) Feedback.--In conducting the study under subsection (a), the
Assistant Secretary for Mental Health and Substance Use shall gather
feedback from the States and opioid treatment programs on their
experiences in implementing exemptions described in subsection (a).
(d) Report.--Not later than 180 days after the end of the period
described in subsection (a)(3)(B), and subject to subsection (c), the
Assistant Secretary for Mental Health and Substance Use shall publish a
report on the results of the study under this section.
SEC. 252. CHANGES TO FEDERAL OPIOID TREATMENT STANDARDS.
(a) Mobile Medication Units.--Section 302(e) of the Controlled
Substances Act (21 U.S.C. 822(e)) is amended by adding at the end the
following:
``(3) Notwithstanding paragraph (1), a registrant that is dispensing
pursuant to section 303(g) narcotic drugs to individuals for
maintenance treatment or detoxification treatment shall not be required
to have a separate registration to incorporate one or more mobile
medication units into the registrant's practice to dispense such
narcotics at locations other than the registrant's principal place of
business or professional practice described in paragraph (1), so long
as the registrant meets such standards for operation of a mobile
medication unit as the Attorney General may establish.''.
(b) Revise Opioid Treatment Program Admission Criteria to Eliminate
Requirement That Patients Have an Opioid Use Disorder for at Least 1
Year.--Not later than 18 months after the date of enactment of this
Act, the Secretary of Health and Human Services shall revise section
8.12(e)(1) of title 42, Code of Federal Regulations (or successor
regulations), to eliminate the requirement that an opioid treatment
program only admit an individual for treatment under the program if the
individual has been addicted to opioids for at least 1 year before
being so admitted for treatment.
(c) Final Regulation on Periods for Take-Home Supply Requirements.--
(1) In general.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate a final regulation amending
paragraphs (i)(3)(i) through (i)(3)(vi) of section 8.12 of
title 42, Code of Federal Regulations, as appropriate based on
the findings of the study under section 251 of this Act.
(2) Criteria.--The regulation under paragraph (1) shall
establish relevant criteria for the medical director or an
appropriately licensed practitioner of an opioid treatment
program, to determine whether a patient is stable and may
qualify for unsupervised use, which criteria may allow for
consideration of each of the following:
(A) Whether the benefits of providing unsupervised
doses to a patient outweigh the risks.
(B) The patient's demonstrated adherence to their
treatment plan.
(C) The patient's history of negative toxicology
tests.
(D) Whether there is an absence of serious behavioral
problems.
(E) The patient's stability in living arrangements
and social relationships.
(F) Whether there is an absence of substance misuse-
related behaviors.
(G) Whether there is an absence of recent diversion
activity.
(H) Whether there is an assurance that the medication
can be safely stored by the patient.
(I) Any other criterion the Secretary of Health and
Human Services determines appropriate.
(3) Prohibited sole consideration.--The regulation under
paragraph (1) shall prohibit the medical director of an opioid
treatment program from considering, as the sole consideration
in determining whether a patient is sufficiently responsible in
handling opioid drugs for unsupervised use, whether the patient
has an absence of recent misuse of drugs (whether narcotic or
nonnarcotic), including alcohol.
Subtitle F--Additional Provisions Relating to Addiction Treatment
SEC. 261. PROHIBITION.
Notwithstanding any provision of this Act and the amendments made by
this Act, no funds made available to carry out this Act or any
amendment made by this Act shall be used to purchase, procure, or
distribute pipes or cylindrical objects intended to be used to smoke or
inhale illegal scheduled substances.
SEC. 262. ELIMINATING ADDITIONAL REQUIREMENTS FOR DISPENSING NARCOTIC
DRUGS IN SCHEDULE III, IV, AND V FOR MAINTENANCE OR
DETOXIFICATION TREATMENT.
(a) In General.--Section 303(g) of the Controlled Substances Act (21
U.S.C. 823(g)) is amended--
(1) by striking paragraph (2);
(2) by striking ``(g)(1) Except as provided in paragraph (2),
practitioners who dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment'' and
inserting ``(g) Practitioners who dispense narcotic drugs
(other than narcotic drugs in schedule III, IV, or V) to
individuals for maintenance treatment or detoxification
treatment'';
(3) by redesignating subparagraphs (A), (B), and (C) as
paragraphs (1), (2), and (3), respectively; and
(4) in paragraph (2), as so redesignated--
(A) by striking ``(i) security of stocks'' and
inserting ``(A) security of stocks''; and
(B) by striking ``(ii) the maintenance of records''
and inserting ``(B) the maintenance of records''.
(b) Conforming Changes.--
(1) Subsections (a) and (d)(1) of section 304 of the
Controlled Substances Act (21 U.S.C. 824) are each amended by
striking ``303(g)(1)'' each place it appears and inserting
``303(g)''.
(2) Section 309A(a)(2) of the Controlled Substances Act (21
U.S.C. 829a) is amended--
(A) in the matter preceding subparagraph (A), by
striking ``the controlled substance is to be
administered for the purpose of maintenance or
detoxification treatment under section 303(g)(2)'' and
inserting ``the controlled substance is a narcotic drug
in schedule III, IV, or V to be administered for the
purpose of maintenance or detoxification treatment'';
and
(B) by striking ``and--'' and all that follows
through ``is to be administered by injection or
implantation;'' and inserting ``and is to be
administered by injection or implantation;''.
(3) Section 520E-4(c) of the Public Health Service Act (42
U.S.C. 290bb-36d(c)) is amended by striking ``information on
any qualified practitioner that is certified to prescribe
medication for opioid dependency under section 303(g)(2)(B) of
the Controlled Substances Act'' and inserting ``information on
any practitioner who prescribes narcotic drugs in schedule III,
IV, or V of section 202 of the Controlled Substances Act for
the purpose of maintenance or detoxification treatment''.
(4) Section 544(a)(3) of the Public Health Service Act (42
U.S.C. 290dd-3), as added by section 219(a)(2), is amended by
striking ``any practitioner dispensing narcotic drugs pursuant
to section 303(g) of the Controlled Substances Act'' and
inserting ``any practitioner dispensing narcotic drugs for the
purpose of maintenance or detoxification treatment''.
(5) Section 1833(bb)(3)(B) of the Social Security Act (42
U.S.C. 1395l(bb)(3)(B)) is amended by striking ``first receives
a waiver under section 303(g) of the Controlled Substances Act
on or after January 1, 2019'' and inserting ``first begins
prescribing narcotic drugs in schedule III, IV, or V of section
202 of the Controlled Substances Act for the purpose of
maintenance or detoxification treatment on or after January 1,
2021''.
(6) Section 1834(o)(3)(C)(ii) of the Social Security Act (42
U.S.C. 1395m(o)(3)(C)(ii)) is amended by striking ``first
receives a waiver under section 303(g) of the Controlled
Substances Act on or after January 1, 2019'' and inserting
``first begins prescribing narcotic drugs in schedule III, IV,
or V of section 202 of the Controlled Substances Act for the
purpose of maintenance or detoxification treatment on or after
January 1, 2021''.
(7) Section 1866F(c)(3) of the Social Security Act (42 U.S.C.
1395cc-6(c)(3)) is amended--
(A) in subparagraph (A), by adding ``and'' at the
end;
(B) in subparagraph (B), by striking ``; and'' and
inserting a period; and
(C) by striking subparagraph (C).
(8) Section 1903(aa)(2)(C) of the Social Security Act (42
U.S.C. 1396b(aa)(2)(C)) is amended--
(A) in clause (i), by adding ``and'' at the end;
(B) by striking clause (ii); and
(C) by redesignating clause (iii) as clause (ii).
SEC. 263. REQUIRING PRESCRIBERS OF CONTROLLED SUBSTANCES TO COMPLETE
TRAINING.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(l) Required Training for Prescribers.--
``(1) Training required.--As a condition on registration
under this section to dispense controlled substances in
schedule II, III, IV, or V, the Attorney General shall require
any qualified practitioner, beginning with the first applicable
registration for the practitioner, to meet the following:
``(A) If the practitioner is a physician, the
practitioner meets one or more of the following
conditions:
``(i) The physician holds a board
certification in addiction psychiatry or
addiction medicine from the American Board of
Medical Specialties.
``(ii) The physician holds a board
certification from the American Board of
Addiction Medicine.
``(iii) The physician holds a board
certification in addiction medicine from the
American Osteopathic Association.
``(iv) The physician has, with respect to the
treatment and management of patients with
opioid or other substance use disorders,
completed not less than 8 hours of training
(through classroom situations, seminars at
professional society meetings, electronic
communications, or otherwise) that is provided
by--
``(I) the American Society of
Addiction Medicine, the American
Academy of Addiction Psychiatry, the
American Medical Association, the
American Osteopathic Association, the
American Psychiatric Association, or
any other organization accredited by
the Accreditation Council for
Continuing Medical Education (commonly
known as the `ACCME');
``(II) any organization accredited by
a State medical society accreditor that
is recognized by the ACCME;
``(III) any organization accredited
by the American Osteopathic Association
to provide continuing medical
education; or
``(IV) any organization approved by
the Assistant Secretary for Mental
Health and Substance Abuse or the
ACCME.
``(v) The physician graduated in good
standing from an accredited school of
allopathic medicine or osteopathic medicine in
the United States during the 5-year period
immediately preceding the date on which the
physician first registers or renews under this
section and has successfully completed a
comprehensive allopathic or osteopathic
medicine curriculum or accredited medical
residency that included not less than 8 hours
of training on treating and managing patients
with opioid and other substance use disorders,
including the appropriate clinical use of all
drugs approved by the Food and Drug
Administration for the treatment of a substance
use disorder.
``(B) If the practitioner is not a physician, the
practitioner meets one or more of the following
conditions:
``(i) The practitioner has completed not
fewer than 8 hours of training with respect to
the treatment and management of patients with
opioid or other substance use disorders
(through classroom situations, seminars at
professional society meetings, electronic
communications, or otherwise) provided by the
American Society of Addiction Medicine, the
American Academy of Addiction Psychiatry, the
American Medical Association, the American
Osteopathic Association, the American Nurses
Credentialing Center, the American Psychiatric
Association, the American Association of Nurse
Practitioners, the American Academy of
Physician Associates, or any other organization
approved or accredited by the Assistant
Secretary for Mental Health and Substance Abuse
or the or the Accreditation Council for
Continuing Medical Education.
``(ii) The practitioner has graduated in good
standing from an accredited physician assistant
school or accredited school of advanced
practice nursing in the United States during
the 5-year period immediately preceding the
date on which the practitioner first registers
or renews under this section and has
successfully completed a comprehensive
physician assistant or advanced practice
nursing curriculum that included not fewer than
8 hours of training on treating and managing
patients with opioid and other substance use
disorders, including the appropriate clinical
use of all drugs approved by the Food and Drug
Administration for the treatment of a substance
use disorder.
``(2) One-time training.--The Attorney General shall not
require any qualified practitioner to complete the training
described in clause (iv) or (v) of paragraph (1)(A) or clause
(i) or (ii) of paragraph (1)(B) more than once.
``(3) Rule of construction.--Nothing in this subsection shall
be construed to preclude the use, by a qualified practitioner,
of training received pursuant to this subsection to satisfy
registration requirements of a State or for some other lawful
purpose.
``(4) Definitions.--In this section:
``(A) First applicable registration.--The term `first
applicable registration' means the first registration
or renewal of registration by a qualified practitioner
under this section that occurs on or after the date
that is 180 days after the date of enactment of the
Restoring Hope for Mental Health and Well-Being Act of
2022.
``(B) Qualified practitioner.--In this subsection,
the term `qualified practitioner' means a practitioner
who--
``(i) is licensed under State law to
prescribe controlled substances; and
``(ii) is not solely a veterinarian.''.
TITLE III--ACCESS TO MENTAL HEALTH CARE AND COVERAGE
Subtitle A--Collaborate in an Orderly and Cohesive Manner
SEC. 301. INCREASING UPTAKE OF THE COLLABORATIVE CARE MODEL.
Section 520K of the Public Health Service Act (42 U.S.C. 290bb-42) is
amended to read as follows:
``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE AGREEMENTS.
``(a) Definitions.--In this section:
``(1) Collaborative care model.--The term `collaborative care
model' means the evidence-based, integrated behavioral health
service delivery method that includes--
``(A) care directed by the primary care team;
``(B) structured care management;
``(C) regular assessments of clinical status using
developmentally appropriate, validated tools; and
``(D) modification of treatment as appropriate.
``(2) Eligible entity.--The term `eligible entity' means a
State, or an appropriate State agency, in collaboration with--
``(A) 1 or more qualified community programs as
described in section 1913(b)(1);
``(B) 1 or more health centers (as defined in section
330(a)), a rural health clinic (as defined in section
1961(aa) of the Social Security Act), or a Federally
qualified health center (as defined in such section);
or
``(C) 1 or more primary health care practices.
``(3) Integrated care; bidirectional integrated care.--
``(A) The term `integrated care' means models or
practices for coordinating and jointly delivering
behavioral and physical health services, which may
include practices that share the same space in the same
facility.
``(B) The term `bidirectional integrated care' means
the integration of behavioral health care and specialty
physical health care, as well as the integration of
primary and physical health care with specialty
behavioral health settings, including within primary
health care settings.
``(4) Primary health care provider.--The term `primary health
care provider' means a provider who--
``(A) provides health services related to family
medicine, internal medicine, pediatrics, obstetrics,
gynecology, or geriatrics; or
``(B) is a doctor of medicine or osteopathy,
physician assistant, or nurse practitioner, who is
licensed to practice medicine by the State in which
such physician, assistant, or practitioner primarily
practices, including within primary health care
settings.
``(5) Primary health care practice.--The term `primary health
care practice' means a medical practice of primary health care
providers, including a practice within a larger health care
system.
``(6) Special population.--The term `special population', for
an eligible entity that is collaborating with an entity
described in subparagraph (A) or (B) of paragraph (3), means--
``(A) adults with a serious mental illness who have a
co-occurring physical health condition or chronic
disease;
``(B) children and adolescents with a mental illness
who have a co-occurring physical health condition or
chronic disease;
``(C) individuals with a substance use disorder; or
``(D) individuals with a mental illness who have a
co-occurring substance use disorder.
``(b) Grants and Cooperative Agreements.--
``(1) In general.--The Secretary may award grants and
cooperative agreements to eligible entities to support the
improvement of integrated care for physical and behavioral
health care in accordance with paragraph (2).
``(2) Use of funds.--A grant or cooperative agreement awarded
under this section shall be used--
``(A) in the case of an eligible entity that is
collaborating with an entity described in subparagraph
(A) or (B) of subsection (a)(2)--
``(i) to promote full integration and
collaboration in clinical practices between
physical and behavioral health care for special
populations including each population listed in
subsection (a)(7);
``(ii) to support the improvement of
integrated care models for physical and
behavioral health care to improve the overall
wellness and physical health status of--
``(I) adults with a serious mental
illness or children with a serious
emotional disturbance; and
``(II) individuals with a substance
use disorder; and
``(iii) to promote bidirectional integrated
care services including screening, diagnosis,
prevention, treatment, and recovery of mental
and substance use disorders, and co-occurring
physical health conditions and chronic
diseases; and
``(B) in the case of an eligible entity that is
collaborating with a primary health care practice, to
support the uptake of the collaborative care model,
including by--
``(i) hiring staff;
``(ii) identifying and formalizing
contractual relationships with other health
care providers, including providers who will
function as psychiatric consultants and
behavioral health care managers in providing
behavioral health integration services through
the collaborative care model;
``(iii) purchasing or upgrading software and
other resources needed to appropriately provide
behavioral health integration services through
the collaborative care model, including
resources needed to establish a patient
registry and implement measurement-based care;
and
``(iv) for such other purposes as the
Secretary determines to be necessary.
``(c) Applications.--
``(1) In general.--An eligible entity that is collaborating
with an entity described in subparagraph (A) or (B) of
subsection (a)(2) seeking a grant or cooperative agreement
under subsection (b)(2)(A) shall submit an application to the
Secretary at such time, in such manner, and accompanied by such
information as the Secretary may require, including the
contents described in paragraph (2).
``(2) Contents.--Any such application of an eligible entity
described in subparagraph (A) or (B) of subsection (a)(2) shall
include--
``(A) a description of a plan to achieve fully
collaborative agreements to provide bidirectional
integrated care to special populations;
``(B) a document that summarizes the policies, if
any, that are barriers to the provision of integrated
care, and the specific steps, if applicable, that will
be taken to address such barriers;
``(C) a description of partnerships or other
arrangements with local health care providers to
provide services to special populations;
``(D) an agreement and plan to report to the
Secretary performance measures necessary to evaluate
patient outcomes and facilitate evaluations across
participating projects;
``(E) a description of how validated rating scales
will be implemented to support the improvement of
patient outcomes using measurement-based care,
including those related to depression screening,
patient follow-up, and symptom remission; and
``(F) a plan for sustainability beyond the grant or
cooperative agreement period under subsection (e).
``(3) Collaborative care model grants.--An eligible entity
that is collaborating with a primary health care practice
seeking a grant pursuant to subsection (b)(2)(B) shall submit
an application to the Secretary at such time, in such manner,
and accompanied by such information as the Secretary may
require.
``(d) Grant and Cooperative Agreement Amounts.--
``(1) Target amount.--The target amount that an eligible
entity may receive for a year through a grant or cooperative
agreement under this section shall be--
``(A) $2,000,000 for an eligible entity described in
subparagraph (A) or (B) of subsection (a)(2); or
``(B) $100,000 or less for an eligible entity
described in subparagraph (C) of subsection (a)(2).
``(2) Adjustment permitted.--The Secretary, taking into
consideration the quality of an eligible entity's application
and the number of eligible entities that received grants under
this section prior to the date of enactment of the Restoring
Hope for Mental Health and Well-Being Act of 2022, may adjust
the target amount that an eligible entity may receive for a
year through a grant or cooperative agreement under this
section.
``(3) Limitation.--An eligible entity that is collaborating
with an entity described in subparagraph (A) or (B) of
subsection (a)(2) receiving funding under this section--
``(A) may not allocate more than 20 percent of the
funds awarded to such eligible entity under this
section to administrative functions; and
``(B) shall allocate the remainder of such funding to
health facilities that provide integrated care.
``(e) Duration.--A grant or cooperative agreement under this section
shall be for a period not to exceed 5 years.
``(f) Report on Program Outcomes.--An eligible entity receiving a
grant or cooperative agreement under this section--
``(1) that is collaborating with an entity described in
subparagraph (A) or (B) of subsection (a)(2) shall submit an
annual report to the Secretary that includes--
``(A) the progress made to reduce barriers to
integrated care as described in the entity's
application under subsection (c); and
``(B) a description of outcomes with respect to each
special population listed in subsection (a)(7),
including outcomes related to education, employment,
and housing; or
``(2) that is collaborating with a primary health care
practice shall submit an annual report to the Secretary that
includes--
``(A) the progress made to improve access;
``(B) the progress made to improve patient outcomes;
and
``(C) the progress made to reduce referrals to
specialty care.
``(g) Technical Assistance for Primary-Behavioral Health Care
Integration.--
``(1) Certain recipients.--The Secretary may provide
appropriate information, training, and technical assistance to
eligible entities that are collaborating with an entity
described in subparagraph (A) or (B) of subsection (a)(2) that
receive a grant or cooperative agreement under this section, in
order to help such entities meet the requirements of this
section, including assistance with--
``(A) development and selection of integrated care
models;
``(B) dissemination of evidence-based interventions
in integrated care;
``(C) establishment of organizational practices to
support operational and administrative success; and
``(D) other activities, as the Secretary determines
appropriate.
``(2) Collaborative care model recipients.--The Secretary
shall provide appropriate information, training, and technical
assistance to eligible entities that are collaborating with
primary health care practices that receive funds under this
section to help such entities implement the collaborative care
model, including--
``(A) developing financial models and budgets for
implementing and maintaining a collaborative care
model, based on practice size;
``(B) developing staffing models for essential staff
roles;
``(C) providing strategic advice to assist practices
seeking to utilize other clinicians for additional
psychotherapeutic interventions;
``(D) providing information technology expertise to
assist with building the collaborative care model into
electronic health records, including assistance with
care manager tools, patient registry, ongoing patient
monitoring, and patient records;
``(E) training support for all key staff and
operational consultation to develop practice workflows;
``(F) establishing methods to ensure the sharing of
best practices and operational knowledge among primary
health care physicians and primary health care
practices that provide behavioral health integration
services through the collaborative care model; and
``(G) providing guidance and instruction to primary
health care physicians and primary health care
practices on developing and maintaining relationships
with community-based mental health and substance use
disorder facilities for referral and treatment of
patients whose clinical presentation or diagnosis is
best suited for treatment at such facilities.
``(3) Additional dissemination of technical information.--In
addition to providing the assistance described in paragraphs
(1) and (2) to recipients of a grant or cooperative agreement
under this section, the Secretary may also provide such
assistance to other States and political subdivisions of
States, Indian Tribes and Tribal organizations (as defined
under the Federally Recognized Indian Tribe List Act of 1994),
outpatient mental health and addiction treatment centers,
community mental health centers that meet the criteria under
section 1913(c), certified community behavioral health clinics
described in section 223 of the Protecting Access to Medicare
Act of 2014, primary care organizations such as Federally
qualified health centers or rural health clinics as defined in
section 1861(aa) of the Social Security Act, primary health
care practices, other community-based organizations, and other
entities engaging in integrated care activities, as the
Secretary determines appropriate.
``(h) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $60,000,000 for each of fiscal
years 2023 through 2027.''.
Subtitle B--Helping Enable Access to Lifesaving Services
SEC. 311. REAUTHORIZATION AND PROVISION OF CERTAIN PROGRAMS TO
STRENGTHEN THE HEALTH CARE WORKFORCE.
(a) Liability Protections for Health Professional Volunteers.--
Section 224(q)(6) of the Public Health Service Act (42 U.S.C.
233(q)(6)) is amended by striking ``October 1, 2022'' and inserting
``October 1, 2027''.
(b) Minority Fellowships in Crisis Care Management.--Section 597(b)
of the Public Health Service Act (42 U.S.C. 290ll(b)) is amended by
striking ``in the fields of psychiatry,'' and inserting ``in the fields
of crisis care management, psychiatry,''.
(c) Mental and Behavioral Health Education and Training Grants.--
Section 756 of the Public Health Service Act (42 U.S.C. 294e-1) is
amended--
(1) in subsection (a)(1), by inserting ``(which may include
master's and doctoral level programs)'' after ``occupational
therapy''; and
(2) in subsection (f), by striking ``For each of fiscal years
2019 through 2023'' and inserting ``For each of fiscal years
2023 through 2027''.
(d) Training Demonstration Program.--Section 760(g) of the Public
Health Service Act (42 U.S.C. 294k(g)) is amended by inserting ``and
$31,700,000 for each of fiscal years 2023 through 2027'' before the
period at the end.
Subtitle C--Eliminating the Opt-Out for Nonfederal Governmental Health
Plans
SEC. 321. ELIMINATING THE OPT-OUT FOR NONFEDERAL GOVERNMENTAL HEALTH
PLANS.
Section 2722(a)(2) of the Public Health Service Act (42 U.S.C. 300gg-
21(a)(2)) is amended by adding at the end the following new
subparagraph:
``(F) Sunset of election option.--
``(i) In general.--Notwithstanding the
preceding provisions of this paragraph--
``(I) no election described in
subparagraph (A) with respect to
section 2726 may be made on or after
the date of the enactment of this
subparagraph; and
``(II) except as provided in clause
(ii), no such election with respect to
section 2726 expiring on or after the
date that is 180 days after the date of
such enactment may be renewed.
``(ii) Exception for certain collectively
bargained plans.--Notwithstanding clause
(i)(II), a plan described in subparagraph
(B)(ii) that is subject to multiple agreements
described in such subparagraph of varying
lengths and that has an election described in
subparagraph (A) with respect to section 2726
in effect as of the date of the enactment of
this subparagraph that expires on or after the
date that is 180 days after the date of such
enactment may extend such election until the
date on which the term of the last such
agreement expires.''.
Subtitle D--Mental Health and Substance Use Disorder Parity
Implementation
SEC. 331. GRANTS TO SUPPORT MENTAL HEALTH AND SUBSTANCE USE DISORDER
PARITY IMPLEMENTATION.
(a) In General.--Section 2794(c) of the Public Health Service Act (42
U.S.C. 300gg-94(c)) (as added by section 1003 of the Patient Protection
and Affordable Care Act (Public Law 111-148)) is amended by adding at
the end the following:
``(3) Parity implementation.--
``(A) In general.--Beginning during the first fiscal
year that begins after the date of enactment of this
paragraph, the Secretary shall, out of funds made
available pursuant to subparagraph (C), award grants to
eligible States to enforce and ensure compliance with
the mental health and substance use disorder parity
provisions of section 2726.
``(B) Eligible state.--A State shall be eligible for
a grant awarded under this paragraph only if such
State--
``(i) submits to the Secretary an application
for such grant at such time, in such manner,
and containing such information as specified by
the Secretary; and
``(ii) agrees to request and review from
health insurance issuers offering group or
individual health insurance coverage the
comparative analyses and other information
required of such health insurance issuers under
subsection (a)(8)(A) of section 2726 relating
to the design and application of
nonquantitative treatment limitations imposed
on mental health or substance use disorder
benefits.
``(C) Authorization of appropriations.--There are
authorized to be appropriated $10,000,000 for each of
the first five fiscal years beginning after the date of
the enactment of this paragraph, to remain available
until expended, for purposes of awarding grants under
subparagraph (A).''.
(b) Technical Amendment.--Section 2794 of the Public Health Service
Act (42 U.S.C. 300gg-95), as added by section 6603 of the Patient
Protection and Affordable Care Act (Public Law 111-148) is redesignated
as section 2795.
TITLE IV--CHILDREN AND YOUTH
Subtitle A--Supporting Children's Mental Health Care Access
SEC. 401. PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
Section 330M of the Public Health Service Act (42 U.S.C. 254c-19) is
amended--
(1) in the section enumerator, by striking ``330M'' and
inserting ``330M.'';
(2) in subsection (a)--
(A) by striking ``Indian tribes and tribal
organizations'' and inserting ``Indian Tribes and
Tribal organizations''; and
(B) by inserting ``or, in the case of a State that
does not submit an application, a nonprofit entity that
has the support of the State'' after ``450b))'';
(3) in subsection (b)--
(A) in paragraph (1)--
(i) in subparagraph (G), by inserting
``developmental-behavioral pediatricians,''
after ``adolescent psychiatrists,'';
(ii) in subparagraph (H), by striking ``;
and'' at the end and inserting a semicolon;
(iii) by redesignating subparagraph (I) as
subparagraph (J); and
(iv) by inserting after subparagraph (H) the
following:
``(I) maintain an up-to-date list of community-based
supports for children with mental health problems;
and'';
(B) by redesignating paragraph (2) as paragraph (4);
(C) by inserting after paragraph (1) the following:
``(2) Support to schools and emergency departments.--In
addition to the activities required by paragraph (1), a
pediatric mental health care telehealth access program referred
to in subsection (a), with respect to which a grant under such
subsection may be used, may provide support to schools and
emergency departments.
``(3) Priority.--In awarding grants under this section, the
Secretary shall give priority to applicants proposing to--
``(A) continue existing programs that meet the
requirements of paragraph (1);
``(B) establish a pediatric mental health care
telehealth access program in the jurisdiction of a
State, Territory, Indian Tribe, or Tribal organization
that does not yet have such a program; or
``(C) expand a pediatric mental health care
telehealth access program to include one or more new
sites of care, such as a school or emergency
department.''; and
(D) in paragraph (4), as redesignated by subparagraph
(B), by inserting ``Such a team may include a
developmental-behavioral pediatrician.'' after ``mental
health counselor.'';
(4) in subsections (c), (d), and (f), by striking ``Indian
tribe, or tribal organization'' each place it appears and
inserting ``Indian Tribe, Tribal organization, or nonprofit
entity''; and
(5) by striking subsection (g) and inserting the following:
``(g) Technical Assistance.--The Secretary shall award grants or
contracts to one or more eligible entities (as defined by the
Secretary) for the purposes of providing technical assistance and
evaluation support to grantees under subsection (a).
``(h) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated--
``(1) $14,000,000 for each of fiscal years 2023 through 2025;
and
``(2) $30,000,000 for each of fiscal years 2026 through
2027.''.
SEC. 402. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
INTERVENTION, AND TREATMENT.
Section 399Z-2(f) of the Public Health Service Act (42 U.S.C. 280h-
6(f)) is amended by striking ``$20,000,000 for the period of fiscal
years 2018 through 2022'' and inserting ``$50,000,000 for the period of
fiscal years 2023 through 2027''.
Subtitle B--Continuing Systems of Care for Children
SEC. 411. COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CHILDREN
WITH SERIOUS EMOTIONAL DISTURBANCES.
(a) Definition of Family.--Section 565(d)(2)(B) of the Public Health
Service Act (42 U.S.C. 290ff-4(d)(2)(B)) is amended by striking ``as
appropriate regarding mental health services for the child, the parents
of the child (biological or adoptive, as the case may be) and any
foster parents of the child'' and inserting ``as appropriate regarding
mental health services for the child and the parents or kinship
caregivers of the child''.
(b) Authorization of Appropriations.--Paragraph (1) of section 565(f)
of the Public Health Service Act (42 U.S.C. 290ff-4(f)) is amended--
(1) by moving the margin of such paragraph 2 ems to the
right; and
(2) by striking ``$119,026,000 for each of fiscal years 2018
through 2022'' and inserting ``$125,000,000 for each of fiscal
years 2023 through 2027''.
SEC. 412. SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION
SERVICES FOR CHILDREN AND ADOLESCENTS.
Section 514 of the Public Health Service Act (42 U.S.C. 290bb-7) is
amended--
(1) in subsection (a), by striking ``Indian tribes or tribal
organizations'' and inserting ``Indian Tribes or Tribal
organizations''; and
(2) in subsection (f), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
Subtitle C--Garrett Lee Smith Memorial Reauthorization
SEC. 421. SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.
(a) Technical Amendment.--Section 520C of the Public Health Service
Act (42 U.S.C. 290bb-34) is amended--
(1) by striking ``tribes'' and inserting ``Tribes''; and
(2) by striking ``tribal'' each place it appears and
inserting ``Tribal''.
(b) Authorization of Appropriations.--Section 520C(c) of the Public
Health Service Act (42 U.S.C. 290bb-34(c)) is amended by striking
``$5,988,000 for each of fiscal years 2018 through 2022'' and inserting
``$9,000,000 for each of fiscal years 2023 through 2027''.
(c) Annual Report.--Section 520C(d) of the Public Health Service Act
(42 U.S.C. 290bb-34(d)) is amended by striking ``Not later than 2 years
after the date of enactment of this subsection'' and inserting ``Not
later than 2 years after the date of enactment of the Restoring Hope
for Mental Health and Well-Being Act of 2022''.
SEC. 422. YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
Section 520E of the Public Health Service Act (42 U.S.C. 290bb-36) is
amended--
(1) by striking ``tribe'' and inserting ``Tribe'';
(2) by striking ``tribal'' each place it appears and
inserting ``Tribal'';
(3) in subsection (a)(1), by inserting ``pediatric health
programs,'' after ``foster care systems,'';
(4) by amending subsection (b)(1)(B) to read as follows:
``(B) a public organization or private nonprofit
organization designated by a State or Indian Tribe (as
defined under the Federally Recognized Indian Tribe
List Act of 1994) to develop or direct the State-
sponsored statewide or Tribal youth suicide early
intervention and prevention strategy; or'';
(5) in subsection (c)--
(A) in paragraph (1), by inserting ``pediatric health
programs,'' after ``foster care systems,'';
(B) in paragraph (7), by inserting ``pediatric health
programs,'' after ``foster care systems,'';
(C) in paragraph (9), by inserting ``pediatric health
programs,'' after ``educational institutions,'';
(D) in paragraph (13), by striking ``and'' at the
end;
(E) in paragraph (14), by striking the period at the
end and inserting ``; and''; and
(F) by adding at the end the following:
``(15) provide to parents, legal guardians, and family
members of youth, supplies to securely store means commonly
used in suicide, if applicable, within the household.'';
(6) in subsection (d)--
(A) in the heading, by striking ``Direct Services''
and inserting ``Suicide Prevention Activities''; and
(B) by striking ``direct services, of which not less
than 5 percent shall be used for activities authorized
under subsection (a)(3)'' and inserting ``suicide
prevention activities'';
(7) in subsection (e)(3)(A), by inserting ``and Department of
Education'' after ``Department of Health and Human Services'';
(8) in subsection (g)--
(A) in paragraph (1), by striking ``18'' and
inserting ``24''; and
(B) in paragraph (2), by striking ``2 years after the
date of enactment of Helping Families in Mental Health
Crisis Reform Act of 2016'' and inserting ``3 years
after December 31, 2022'';
(9) in subsection (l)(4), by striking ``between 10 and 24
years of age'' and inserting ``up to 24 years of age''; and
(10) in subsection (m), by striking ``$30,000,000 for each of
fiscal years 2018 through 2022'' and inserting ``$40,000,000
for each of fiscal years 2023 through 2027''.
SEC. 423. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES FOR
STUDENTS IN HIGHER EDUCATION.
Section 520E-2 of the Public Health Service Act (42 U.S.C. 290bb-36b)
is amended--
(1) in the heading, by striking ``on campus'' and inserting
``for students in higher education''; and
(2) in subsection (i), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
SEC. 424. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION AT
INSTITUTIONS OF HIGHER EDUCATION.
Section 549 of the Public Health Service Act (42 U.S.C. 290ee-4) is
amended--
(1) in the heading, by striking ``on college campuses'' and
inserting ``at institutions of higher education'';
(2) in subsection (c)(2), by inserting ``, including
minority-serving institutions as described in section 371(a) of
the Higher Education Act of 1965 (20 U.S.C. 1067q) and
community colleges'' after ``higher education''; and
(3) in subsection (f), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
I. Purpose and Summary
H.R. 7666, the ``Restoring Hope for Mental Health and Well-
Being Act of 2022,'' amends the Public Health Service Act to
reauthorize and establish certain mental health and substance
use disorder programs at the Substance Abuse and Mental Health
Services Administration (SAMHSA) and the Health Resources and
Services Administration (HRSA) through fiscal year 2027, for
the purposes of improving Americans' mental health and
addressing substance use disorders. H.R. 7666 includes
provisions to support crisis care and other mental health
services for a range of populations, as well as substance use
disorder prevention, treatment, and recovery support services.
The legislation provides increased support for youth suicide
prevention, maternal mental health, and jail diversion
programs. Further, the bill includes provisions to assist in
addiction and overdose prevention and treatment, including
expanded access to medication-assisted treatment and provider
training. H.R. 7666 also facilitates further integration of
mental health and primary care services, bolsters the mental
health care workforce, applies mental health parity
requirements to self-funded, non-governmental plans, and
supports enforcement of mental health parity requirements.
II. Background and Need for Legislation
Americans have been in the midst of a mental health and
substance use disorder crisis predating the emergence of the
coronavirus disease of 2019 (COVID-19). Increased social
isolation and stress caused by the pandemic further exacerbated
these challenges,\1\ with American adults reporting elevated
levels of mental illness (AMI) including anxiety, depression,
and suicidal ideation.\2\ Children and teens have also
experienced major increases in adverse mental health
symptoms.\3\ Among youth ages 10 and older, the national
suicide rate increased by more than 25 percent since 1999,
nearly doubling in some states.\4\ In addition, one out of five
women will experience maternal mental health conditions, such
as depression, anxiety, or substance use disorder, during
pregnancy or the first year following childbirth.\5\ Suicide
and substance use disorder are some of the leading causes of
death in the first year postpartum.\6\
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\1\Kaiser Family Foundation, The implications of COVID-19 for
mental health and substance use (Feb. 10, 2021).
\2\Centers for Disease Control and Prevention, Morbidity and
Mortality Weekly Report, Mental Health, Substance Use, and Suicidal
Ideation During the COVID-19 Pandemic--United States, June 24-30, 2020
(Aug. 14, 2020).
\3\Surgeon General, Protecting Youth Mental Health: The U.S.
Surgeon General's Advisory (Dec. 7, 2021).
\4\Centers for Disease Control and Prevention, Supplementary Table.
Trends in Suicide Rates among Persons 10 Years of Age, by State and
Sex, National Vital Statistics System, 1999-2016 (June 8, 2018)
(https://stacks.cdc.gov/view/cdc/53785).
\5\Obstetrics & Gynecology, ACOG Committee Opinion No. 757,
Screening for Perinatal Depression (journals.lww.com/greenjournal/
Fulltext/2018/11000/ACOG_Committee_Opinion_No_757_
Screening_for.42.aspx); Fawcett, et. al, The Prevalence of Anxiety
Disorders During Pregnancy and the Postpartum Period, J. Clin
Psychiatry (July 23, 2019) (pubmed.ncbi.nlm.nih.gov/31347796/).
\6\See Pregnancy-Related Deaths; Data from 14 U.S. Maternal
Mortality Review Committees, 2008-2017 (www.cdc.gov/reproductivehealth/
maternal-mortality/erase-mm/MMR-Data-Brief_2019-h.pdf).
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The state of substance use disorders in the United States
has followed a similar upward trajectory in recent years.
Nearly 108,000 people died due to drug overdose in 2021, a
record-breaking number that followed a 30 percent increase in
the rate of overdose deaths from 2019 to 2020.\7\ Additionally,
substance use disorders frequently co-occur with mental health
disorders, such as anxiety and depression.\8\ Nearly 50 percent
of individuals who develop a mental health disorder will also
experience a substance use disorder, and vice versa.\9\
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\7\Centers for Disease Control and Prevention, Vital Statistics
Rapid Release (www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm)
(accessed June 6, 2022); Overdose Deaths Continue Rising, With Fentanyl
and Meth Key Culprits, New York Times (May 11, 2022).
\8\National Institute on Drug Abuse, Common Comorbidities with
Substance Use Disorders Research Report (April 2020).
\9\Id.
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Despite high rates of mental health conditions and
substance use disorders, access to treatment and services
remains limited. In 2020, for instance, only 1.4 percent of
individuals who were classified as in need of substance use
treatment, and just 46.2 percent of adults with any mental
illness, received treatment.\10\ Major barriers to treatment
include the shortage of mental health professionals which
affects one-third of Americans.\11\ The treatment burden of
mental illnesses is particularly acute among those who
experience disability due to serious mental illness (SMI). SMI
is defined as a mental, behavioral, or emotional disorder
resulting in serious functional impairment, which substantially
interferes with or limits one or more major life
activities.\12\ Those living with SMI--including bipolar
disorder, schizophrenia, and severe depression--are jailed more
than 2 million times each year, often for misdemeanor
crimes.\13\ The U.S. criminal justice system has witnessed
dramatic increases in its mentally ill population during the
past years, with decreasing numbers of psychiatric beds being
identified as one of the major causes.\14\ One-third of the
total homeless population consists of individuals with
untreated SMI, with the rates being even higher in homeless
women and individuals who are chronically homeless.\15\
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\10\Substance Abuse and Mental Health Services Administration. Key
substance use and mental health indicators in the United States:
Results from the 2020 National Survey on Drug Use and Health, Center
for Behavioral Health Statistics and Quality, Substance Abuse and
Mental Health Services Administration (June 1, 2022).
\11\USA FACTS, Over one-third of Americans live in areas lacking
mental health professionals (June 9, 2021) (https://usafacts.org/
articles/over-one-third-of-americans-live-in-areas-lacking-mental-
health-professionals/); U.S. Department of Labor, U.S. Departments of
Labor, Health and Human Services, Treasury Issue 2022 Mental Health
Parity and Addiction Equity Act Report to Congress (June 1, 2022).
\12\National Institute of Mental Health, Mental Illness
(www.nimh.nih.gov/health/statistics/mental-illness) (accessed June 8,
2022).
\13\The Pew Charitable Trusts, Project: Mental Health and Justice
Partnerships (www.pewtrusts.org/en/projects/mental-health-and-justice-
partnerships) (accessed June 8, 2022).
\14\Y. Nina Gao, Relationship Between Psychiatric Inpatient Beds
and Jail Populations in the United States, Journal of Psychiatric
Practice (Jan. 21, 2021).
\15\Treatment Advocacy Center Office of Research & Public Affairs,
Serious Mental Illness and Homelessness (Sept. 2016) (https://
www.treatmentadvocacycenter.org/storage/documents/backgrounders/smi-
and-homelessness.pdf).
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H.R. 7666 reauthorizes 35 SAMHSA and HRSA grant programs
that provide critical support for mental health and substance
use disorder activities at a time when increased services for
these conditions are needed more than ever. These programs were
established or most recently reauthorized through the 21st
Century Cures Act,\16\ the Comprehensive Addiction and Recovery
Act,\17\ or the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment (SUPPORT) for Patients and
Communities Act,\18\ in efforts to curb rising rates of mental
health conditions and substance use disorders.
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\16\Pub. L. 114-255.
\17\Pub. L. 114-198.
\18\Pub. L. 115-271.
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Collectively, through funding to states, territories,
Tribes, Tribal organizations, community-based and consumer-led
organizations, and a range of providers, these programs--
including the respective Community Mental Health Services Block
Grants and the Substance Use Disorder Treatment and Recovery
Services Block Grants--target communities and populations at
increased need for mental health support or services and
substance use disorder prevention, treatment, or recovery
support services--such as for children and adolescents, college
students, pregnant or postpartum women, people of color,
Veterans, those experiencing homelessness, those facing or at
risk of incarceration, and rural communities.
In addition, to respond to the urgent mental health crisis
care needs of Americans, and in preparation of the 9-8-8
National Suicide Prevention Lifeline dialing code launch in
July 2022, H.R. 7666 establishes the SAMHSA Behavioral Health
Crisis Coordinating Office to convene partners and provide
technical assistance to enhance access to crisis care. Further,
the bill requires the Secretary of Health and Human Services
(HHS) to publish best practices for a crisis response continuum
of care, and replaces the reauthorization of the Community
Crisis Response Systems Grants with a Mental Health Crisis
Response Partnership Pilot Program.
To address the rising maternal mental health and substance
use disorder needs across the country, H.R. 7666 establishes a
national hotline to provide information, interventions, and
resources to pregnant and postpartum women at risk of, or
affected by, maternal mental health and substance use
disorders, and establishes a task force to make recommendations
to coordinate and inform a national strategy to improve Federal
and State responses to maternal mental health conditions.
Further, as nearly 29 million Americans have had or will
have an eating disorder at some point in their lives,\19\ the
bill meets an ongoing specific mental health disorder need and
establishes an authorization for the SAMHSA National Center of
Excellence for Eating Disorders. It also authorizes grants to
consumer-led nonprofits and Tribal entities to provide peer-
supported mental health services, including virtual peer
support.
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\19\Deloitte Access Economic. The Social and Economic Cost of
Eating Disorders in the United States of America: A Report for the
Strategic Training Initiative for the Prevention of Eating Disorders
and the Academy for Eating Disorders (June 2020).
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H.R. 7666 also rises to meet the needs of young Americans
disproportionately impacted by mental health challenges and
substance use disorders. Prior to the COVID-19 pandemic, mental
health crises experienced by adolescents were already on the
rise, with 13.2 percent of American children between the ages
of three and 17 experiencing a current, diagnosed mental or
behavioral health condition from 2018 to 2019.\20\ In addition,
suicide rates for Americans ages 10 to 24 has jumped nearly 60
percent between 2007 and 2018.\21\ These trends were
exacerbated by the pandemic, so much so that on December 7,
2021, the Surgeon General issued an advisory on the impact that
COVID-19 has had on the ongoing children's mental health
crisis.\22\ The bill takes numerous steps aimed to address
youth mental health, including: reauthorizing HRSA's Pediatric
Mental Health Care Access grant program, which promotes
behavioral health integration into pediatric primary care by
supporting pediatric mental health care telehealth access
programs in states, and SAMHSA's Infant and Early Childhood
Mental Health Grant Program, which helps to improve outcomes
for children from birth to age 12 by developing, maintaining,
or enhancing mental health promotion, intervention, and
treatment services. The bill further supports continuing mental
health and substance use disorder systems of care for children
through the five-year reauthorization of the Comprehensive
Community Mental Health Services for Children with Serious
Emotional Disturbances Grants and the Enhancement and Expansion
of Treatment and Recovery Services for Adolescents,
Transitional Aged Youth, and their Families--known as the Youth
and Family TREE Grants.
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\20\Health Resources and Services Administration, Mental and
Behavioral Health, NSCH Data Brief (Oct. 2020) (mchb.hrsa.gov/sites/
default/files/mchb/data-research/nsch-data-brief-2019-mental-bh.pdf)
\21\Centers for Disease Control and Prevention, National Vital
Statistics Reports, Volume 69, Number 11: State Suicide Rates Among
Adolescents and Young Adults Aged 10-24: United States, 2000-2018
(Sept. 11, 2020) (www.cdc.gov/nchs/data/nvsr/nvsr69/nvsr-69-11-
508.pdf).
\22\Department of Health and Human Services, U.S. Surgeon General
Issues Advisory on Youth Mental Health Crisis Further Exposed by COVID-
19 Pandemic (Dec. 7, 2021) (press release).
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Many of the millions of older adolescents and young adults
living with a mental or substance use disorder may not realize
they have one or know how to seek help.\23\ H.R. 7666 further
supports youth and young adults across the country through the
reauthorization of the Garrett Lee Smith Memorial Act programs
including the Suicide Prevention Resource Center, the State and
Tribal Youth Suicide Prevention and Early Intervention Grants
Program, the Mental Health Youth Suicide Prevention Campus
Grants, and the Mental and Behavioral Health Public Outreach
and Education at Institutions of Higher Education program.
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\23\Substance Abuse and Mental Health Services Administration,
Mental Illness and Substance Use in Young Adults (www.samhsa.gov.young-
adults) (accessed June 7, 2022).
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In addition, H.R. 7666 reauthorizes the Sober Truth on
Prevention Underage Drinking Programs, supporting a national
media campaign, community-based coalition enhancement grants,
and grants for pediatric provider screening and brief
interventions as well as data collection and research to
prevent and address underage drinking at a time when alcohol
remains the most widely used substance among America's young
people.\24\ The bill reauthorizes a range of other substance-
or intervention-specific programs, such as the grants for
reducing overdose deaths and the emergency department
alternatives to opioids grant program. Further, the bill
requires that the Secretary of HHS, acting through the SAMHSA
Assistant Secretary, collaborate with federal agencies and
stakeholders to update, disseminate and promote through grants
high-quality recovery housing best practices.
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\24\National Institutes of Health, Underage Drinking
(www.niaaa.nih.gov/publications/brochures-and-fact-sheets/underage-
drinking) (accessed June 7, 2022).
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The climbing rate of Americans experiencing mental health
conditions is projected to put a strain on the mental and
behavioral health workforce--according to HRSA's Bureau of
Health Workforce, a majority of states will experience
shortages of licensed mental health counselors by 2030.\25\ In
addition, as of March 2021, about 122 million Americans were
living in areas experiencing mental health professional
shortages.\26\ H.R. 7666 includes a number of programs to
bolster mental and behavioral health workforce capacity,
including Liability Protections for Health Professional
Volunteers, Mental and Behavioral Health Education and Training
Grants (including updates to the education reference for
occupational therapist), the Training Demonstration Program,
and expansion of the Integration Incentive Grants and
Cooperative Agreements to increase uptake of the collaborate
care model.
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\25\Health Resources and Services Administration, Behavioral Health
Workforce Projections, 2017-2030 (bhw.hrsa.gov/sites/default/files/
bureau-health-workforce/data-research/bh-workforce-projections-fact-
sheet.pdf) (accessed June 7, 2022).
\26\U.S. News and World Report, Many States Face Shortage of Mental
Health Providers (June 10, 2021) (www.usnews.com/news/best-states/
articles/2021-06-10/northeastern-states-have-fewest-mental-health-
provider-shortages).
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Even with access to mental health and substance use
disorder prevention, treatment, and care, consumers with health
care coverage face numerous challenges accessing mental health
and substance disorder benefits provided by their health
insurance plans.\27\ The Paul Wellstone and Pete Domenici
Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)
requires parity between mental health and substance use
disorder benefits and medical/surgical benefits of health
plans.\28\ The MHPAEA prohibits coverage requirements for
mental health and substance disorder benefits from being more
restrictive than those for medical/surgical benefits, and
prevents health insurance plans that provide mental health or
substance use disorder benefits from imposing less favorable
financial requirements and treatment limitations on those
benefits than on medical/surgical benefits. However, some
health insurance plans fail to comply with parity requirements
of the MHPAEA, and as a result, consumers face more coverage
limitations for behavioral health services than for medical/
surgical benefits.\29\ A recent report by the Departments of
HHS, Treasury, and Labor found that some health plans and
health insurance issuers are failing to deliver parity for
mental health and substance use disorder benefits to those they
cover.\30\ H.R. 7666 authorizes funding to assist States to
enforce and ensure compliance with mental health parity, and
requires self-funded, non-federal governmental plans to comply
with mental health parity requirements.
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\27\Government Accountability Office, Mental Health Care: Consumers
with Coverage Face Access Challenges (Mar. 30, 2022).
\28\Pub. L. 110-343.
\29\Id; Department of Treasury, Realizing Parity, Reducing Stigma,
and Raising Awareness: Increasing Access to Mental Health and Substance
Use Disorder Coverage (2022) www.dol.gov/sites/dolgov/files/EBSA/laws-
and-regulations/laws/mental-health-parity/report-to-congress-2022-
realizing-parity-reducing-stigma-and-raising-awareness.pdf (Report to
Congress).
\30\Id.
---------------------------------------------------------------------------
It is estimated that more than 2 million people in the
United States have an opioid use disorder (OUD), a chronic
brain disease caused by prolonged use of opioids, such as
fentanyl, oxycodone, and heroin.\31\ There are three FDA-
approved medications used to treat OUD, methadone,
buprenorphine, and extended-release naltrexone; these
medications reduce cravings and reduce the risk future use,
which greatly reduces the risk of fatal overdose.\32\ However,
access to these medications is not widely available to those
who may benefit the most, and there are disparities in access
across different populations.\33\ The bill includes provisions
that reduce regulatory barriers, enhance provider education,
and increase access to medication-assisted treatment for OUD.
---------------------------------------------------------------------------
\31\National Academy of Sciences, Engineering, and Science (NASEM),
Consensus Study Report: Medications for Opioid Use Disorder Save Lives
(2019) (https://bit.ly/2NJnNXQ).
\32\
\33\Id.
---------------------------------------------------------------------------
Scientific literature shows that regulatory and
administrative burdens create barriers to accessing treatment
for OUD. For example, methadone is only accessible through
specialty treatment facilities known as opioid treatment
programs (OTPs). OTPs are strictly regulated by the Drug
Enforcement Administration (DEA) and SAMHSA.\34\ Limits to how,
where, and when patients can access OUD treatment limits uptake
of life-saving medications.\35\ During the public health
emergency declared to respond to the COVID-19 pandemic,
regulatory flexibilities were provided to OTPs and
practitioners seeking to dispense medications to treat OUD. In
2020, SAMHSA implemented regulatory flexibilities for take-
home-methadone doses; preliminary studies show that methadone
uptake among patients with OUD nearly doubled and was not
associated with negative health outcomes, such as increased
fatal drug overdoses.36,37 Provisions in this bill
allow OTPs to operate mobile medication units to dispense
methadone without a separate DEA registration; eliminate the
requirement that patients have OUD for one year before becoming
eligible for admission into an OTP; direct SAMHSA to study the
regulatory flexibilities exercised during the COVID-19 pandemic
and submit a report to Congress with their findings; and
requires SAMHSA to develop criteria and update regulations for
OTPs to dispense take-home methadone doses.
---------------------------------------------------------------------------
\34\42 CFR 8.12.
\35\Id.
\36\Substance Abuse and Mental Health Services Administration,
SAMHSA Extends the Methadone Take-Home Flexibility for One Year While
Working Toward a Permanent Solution (2021) (www.samhsa.gov/newsroom/
press-announcements/202111181000).
\37\American Journal of Drug and Alcohol Abuse, The impact of
relaxation of methadone take-home protocols on treatment outcomes in
the COVID-19 era (Nov. 2021) (pubmed.ncbi.nlm.nih.gov/34670453/).
---------------------------------------------------------------------------
Buprenorphine can be prescribed in office-based settings by
providers who apply for a special DEA waiver, known as the ``X
Waiver.''\38\ It is estimated that one in ten medical providers
hold these waivers and many do not prescribe at the allotted
cap due to perceptions of regulatory complexity.\39\ Further,
studies show that lack of provider education about medication-
assisted treatment for OUD compounds stigma and leads to
reduced patient access.\40\ Integrating OUD treatment education
into mainstream health systems and reducing regulatory barriers
is likely to increase provider knowledge and patient
access.\41\ During the COVID-19 pandemic, SAMHSA has also
allowed practitioners to treat up to 30 patients with
buprenorphine for OUD without a separate DEA registration,
citing it as an important first step in decreasing barriers to
treatment.\42\
---------------------------------------------------------------------------
\38\End Substance Use Disorder, Federal barriers to prescribing
buprenorphine (the X-Waiver) (www.endsud.org/mat-act-federal-barriers/
#mat-act).
\39\Id.
\40\National Academy of Sciences, Engineering, and Science,
Consensus Study Report: Medications for Opioid Use Disorder Save Lives
(2019) (https://nap.nationalacademies.org/catalog/25310/medications-
for-opioid-use-disorder-save-lives).
\41\Id.
\42\Substance Abuse and Mental Health Services Administration, FAQs
About the New Buprenorphine Practice Guidelines (2021) (www.samhsa.gov/
medication-assisted-treatment/become-buprenorphine-waivered-
practitioner/new-practice-guidelines-faqs).
---------------------------------------------------------------------------
The legislation eliminates the requirement for health
practitioners to apply for the ``X-waiver'' in order to
prescribe buprenorphine. It further requires health
practitioners to meet a one-time, eight-hour training
requirement on treating and identifying patients with substance
use disorders as a condition of receiving or renewing a DEA
registration to dispense controlled substances.
III. Committee Hearings
For the purposes of section 3(c) of rule XIII of the Rules
of the House of Representatives, the following hearing was used
to develop or consider H.R. 7666:
The Subcommittee on Health held a legislative hearing on
April 5, 2022, entitled ``Communities in Need: Legislation to
Support Mental Health and Well-Being.'' The Subcommittee
received testimony from the following witnesses:
Panel I:
Miriam E. Delphin-Rittmon, Ph.D., Assistant
Secretary for Mental Health and Substance Use,
Substance Abuse and Mental Health Services
Administration; and
Carole Johnson, M.A., Administrator, Health
Resources and Services Administration.
Panel II:
Rebecca W. Brendel, M.D., J.D., President-
Elect, American Psychiatric Association;
Sandy L. Chung, M.D., F.A.A.P., F.A.C.H.E.,
President-Elect, American Academy of Pediatrics;
Steven Adelsheim, M.D., Clinical Professor
of Psychiatry and Director, Stanford Center for Youth
Mental Health and Wellbeing, Stanford University School
of Medicine, Stanford Children's Health;
Debra Pinals, M.D., Medical Director,
Behavioral Health and Forensic Programs, Michigan
Department of Health and Human Services, On behalf of
the National Association of State Mental Health Program
Directors;
Cassandra Price, M.B.A., Director, Office of
Addictive Diseases, Georgia Department of Behavioral
Health and Developmental Disabilities, On behalf of the
National Association of State Alcohol and Drug Abuse
Directors; and
LeVail W. Smith, C.P.S.S., Peer Support
Specialist Instructor and Mentor.
IV. Committee Consideration
H.R. 7666, the ``Restoring Hope for Mental Health and Well-
Being Act of 2022,'' was introduced on May 6, 2022, by
Representatives Pallone (D-NJ) and Rodgers (R-WA) and referred
to the Committee on Energy and Commerce. Subsequently, on May
9, 2022, the bill was referred to the Subcommittee on Health.
On May 11, 2022, the Subcommittee on Health met in open
markup session, pursuant to notice, to consider H.R. 7666 and
five other bills. During consideration of the bill, no
amendments were offered. Upon conclusion of consideration of
the bill, the Subcommittee on Health agreed to report the bill
favorably to the full Committee, without amendment, by a roll
call vote of 32 yeas to zero nays.
On May 18, 2022, the full Committee met in open markup
session, pursuant to notice, to consider H.R. 7666 and five
other bills. An amendment in the nature of a substitute (AINS),
offered by Representative Pallone, was agreed to by a voice
vote. An amendment to the AINS, offered by Representative Tonko
(D-NY), was agreed to by a roll call vote of 45 yeas to 10
nays. An amendment to the Tonko amendment to the AINS, offered
by Representative Burgess (R-TX), was withdrawn. An amendment
to the AINS, offered by Representative Trahan (D-MA), was
agreed to by a roll call vote of 46 yeas to 8 nays. An
amendment to the AINS, offered by Representative Upton (R-MI),
was agreed to by a roll call vote of 55 yeas to one nay. An
amendment to the AINS, offered by Representative Cardenas (D-
CA), was agreed to by a roll call vote of 31 yeas to 24 nays.
An amendment to the bill, offered by Representative Curtis (R-
UT), was withdrawn. Upon conclusion of consideration of the
bill, the full Committee agreed to a motion on final passage
offered by Representative Pallone, Chairman of the Committee,
to order H.R. 7666 reported favorably to the House, amended, by
a voice vote.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were five record votes taken on
H.R. 7666. The motion on final passage of the bill ordering
H.R. 7666 favorably reported to the House, amended, was
approved by a voice vote. The following are the record votes
taken during Committee consideration, including the names of
those members voting for and against:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
The Committee has requested but not received from the
Director of the Congressional Budget Office a statement as to
whether this bill contains any new budget authority, spending
authority, credit authority, or an increase or decrease in
revenues or tax expenditures.
VIII. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
IX. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to amend
the Public Health Service Act to reauthorize certain programs
relating to mental health and substance use disorders to
support the mental health of Americans.
X. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 7666 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XI. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 7666 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIII. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XIV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XV. Section-by-Section Analysis of the Legislation
Section. 1. Short title; Table of contents
Section 1 designates that the short title may be cited as
the ``Restoring Hope for Mental Health and Well-Being Act of
2022.''
TITLE I: MENTAL HEALTH AND CRISIS CARE NEEDS
SUBTITLE A--CRISIS CARE SERVICES AND 9-8-8 IMPLEMENTATION
Sec. 101. Behavioral Health Crisis Coordinating Office
Section 101 establishes the Behavioral Health Crisis
Coordinating Office within the Substance Abuse and Mental
Health Services Administration (SAMHSA) to convene partners and
provide technical assistance to enhance access to crisis care,
authorized at $5 million annually for fiscal years 2023 through
2027.
Sec. 102. Crisis response continuum of care
Section 102 requires the Secretary of HHS to publish best
practices for a crisis response continuum of care not later
than one year after the date of enactment for use by health
care providers, crisis services administrators, and crisis
services providers.
SUBTITLE B--INTO THE LIGHT FOR MATERNAL MENTAL HEALTH AND SUBSTANCE USE
DISORDERS
Sec. 111. Screening and treatment for maternal mental health and
substance use disorders
Section 111 reauthorizes section 317L-1 of the Public
Health Service Act (PHSA) to award Screening and Treatment for
Maternal Mental Health and Substance Use Disorders grants to
states to establish, improve, or maintain programs for
screening, assessment, and treatment services for women who are
postpartum, pregnant, or have given birth within the preceding
12 months, for maternal mental health and substance use
disorders. The grants are authorized at $24 million annually
for fiscal years 2023 through 2027.
Sec. 112. Maternal mental health hotline
Section 112 establishes a national hotline to provide
information, brief intervention, and mental health and
substance use disorder resources to pregnant and postpartum
women at risk of, or affected by, maternal mental health and
substance use disorders, and authorizes $10 million annually
for fiscal years 2023 through 2027.
Sec. 113. Task force on maternal mental health
Section 113 establishes a task force to make
recommendations to coordinate and inform a national strategy to
improve federal and state responses to maternal mental health
conditions and requires a report to Congress and to governors
and state leaders two years after the first meeting of the task
force.
SUBTITLE C--REACHING IMPROVED MENTAL HEALTH OUTCOMES FOR PATIENTS
Sec. 121. Innovation for mental health
Section 121 replaces the unfunded Community Crisis Response
Systems Grants authorization with an authorization of $10
million annually for fiscal years 2023 through 2027 for the
establishment of a Mental Health Crisis Response Partnership
Pilot Program.
Sec. 122. Crisis care coordination
Section 122 reauthorizes five additional SAMHSA programs to
address mental health needs, provide crisis response care, and
prevent suicide among adults for fiscal years 2023 through
2027, including: National Mental Health and Substance Abuse
Policy Laboratory, authorized at $10 million for each fiscal
year; Interdepartmental Serious Mental Illness Coordinating
Committee; Mental Health Needs Priority Regions of National
Significance (PRNS), authorized at $599.036 million for each
fiscal year; Mental Health Awareness Training (MHAT) Grants,
authorized at $24.963 million for each fiscal year; and Adult
Suicide Prevention, authorized at $30 million for each fiscal
year.
Sec. 123. Treatment of serious mental illness
Section 123 reauthorizes two programs for the treatment of
serious mental illness, the Assertive Community Treatment
Grants, authorized at $9 million for each fiscal year for
fiscal years 2023 through 2027 and the Assisted Outpatient
Treatment Grant Program for Individuals with Serious Mental
Illness, authorized at $22 million for each fiscal year for the
same period.
SUBTITLE D--ANNA WESTIN LEGACY
Sec. 131. Maintaining education and training on eating disorders
Section 131 establishes an authorization for the SAMHSA
National Center of Excellence for Eating Disorders at $1
million annually for fiscal years 2023 through 2027 to award
competitive subgrants or subcontracts for the development and
provision of training and technical assistance to primary and
behavioral health providers and non-clinical community support
workers as well as collaboration and coordination with SAMHSA,
the Centers for Disease Control and Prevention, and the Health
Resources and Services Administration (HRSA) on the
identification, effective treatment, and ongoing support of
individuals with eating disorders.
SUBTITLE E--COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT
REAUTHORIZATION
Sec. 141. Reauthorization of block grants for community mental health
services
Section 141 reauthorizes the Community Mental Health
Services Block Grants for states, territories, Tribes, and
Tribal organizations to support community mental health
services for adults with serious mental illness and children
with serious emotional disturbance and to support the
collection of performance and outcome data. This section also
requires that five percent of the funds granted be used for
crisis-care services and allows for up to five percent of funds
for early intervention activities. This section authorizes
$857.571 million annually for fiscal years 2023 through 2027.
SUBTITLE F--PEER-SUPPORTED MENTAL HEALTH SERVICES
Sec. 151. Peer-supported mental health services
Section 151 authorizes $13 million annually for fiscal
years 2023 through 2027 for grants to consumer-led nonprofits,
Tribes and Tribal organizations, Urban Indian organizations, or
Tribal consortium to provide peer-supported mental health
services, including virtual peer support.
TITLE II: SUBSTANCE USE DISORDER PREVENTION, TREATMENT, AND RECOVERY
SERVICES
SUBTITLE A--NATIVE BEHAVIORAL HEALTH ACCESS IMPROVEMENT
Sec. 201. Behavioral health and substance use disorder services for
Native Americans
Section 201 reauthorizes the Alcohol and Drug Prevention or
Treatment Services for Indians and Native Alaskans Grant
Program to provide culturally appropriate mental health and
substance use disorder prevention, treatment, and recovery
services to American Indians, Alaska Natives, and Native
Hawaiians. This section requires the convening of a negotiated
rulemaking committee composed of representatives of the federal
government, Tribal Governments, and Urban Indian Organizations
to establish a funding formula and program evaluation
standards. This section authorizes $40 million annually for
fiscal years 2023 through 2027.
SUBTITLE B--SUMMER BARROW PREVENTION, TREATMENT, AND RECOVERY
Sec. 211. Grants for the benefit of homeless individuals
Section 211 reauthorizes formula grants for the benefit of
homeless individuals, administered through SAMHSA, authorized
at $41.304 million for each fiscal year for fiscal years 2023
through 2027.
Sec. 212. Priority substance abuse treatment needs of regional and
national significance
Section 212 reauthorizes the SAMHSA Substance Use Disorder
Treatment Programs of Regional and National Significance
(PRNS), authorized at $521.517 million for each fiscal year for
fiscal years 2023 through 2027.
Sec. 213. Evidence-based prescription opioid and heroin treatment and
interventions demonstration
Section 213 reauthorizes the Prescription Opioid and Heroin
Treatment and Interventions Demonstration Grants, administered
by SAMHSA, authorized at $25 million for each fiscal year for
fiscal years 2023 through 2027.
Sec. 214. Priority substance use disorder prevention needs of regional
and national significance
Section 214 reauthorizes the SAMHSA Substance Use Disorder
Prevention PRNS, authorized at $218.219 million for each fiscal
year for fiscal years 2023 through 2027.
Sec. 215. Sober Truth on Preventing (STOP) Underage Drinking
Reauthorization
Section 215 reauthorizes programs to reduce underage
drinking, including requiring an annual report, a national
media campaign, extending Community-based Coalition Enhancement
Grants to Prevent Underage Drinking, Pediatric Provider
Screening and Brief Intervention Grants, and data collection
and research, collectively authorized at $23 million for each
fiscal year for fiscal years 2023 through 2027. This section
also requires a National Academy of Sciences review and report
to Congress authorized at $500,000 for fiscal year 2023.
Sec. 216. Grants for jail diversion programs
Section 216 reauthorizes the SAMHSA Jail Diversion Program
and Grants, authorized at $14 million each fiscal year for
fiscal years 2023 through 2027.
Sec. 217. Formula grants to States
Section 217 authorizes formula grants to states from fiscal
years 2023 through 2027.
Sec. 218. Projects for Assistance in Transition From Homelessness
Section 218 reauthorizes SAMHSA's Projects for Assistance
in Transition from Homelessness Program, authorized at $64.635
million each fiscal year for fiscal years 2023 through 2027.
Sec. 219. Grants for reducing overdose deaths
Section 219 reauthorizes SAMHSA grants for reducing
overdose deaths, including supporting the development of
strategic opioid crisis response plans, authorized at $5
million each fiscal year for fiscal years 2023 through 2027.
Sec. 220. Opioid overdose reversal medication access and education
grant programs
Section 220 reauthorizes Opioid Overdose Reversal
Medication Access, Education, and Co-prescribing Grants,
requiring health care practitioners to prescribe an opioid
reversal drug when prescribing an opioid for certain patients,
authorized at $5 million each fiscal year for fiscal years 2023
through 2027.
Sec. 221. State demonstration grants for comprehensive opioid abuse
response
Section 221 reauthorizes SAMHSA grants for State and Local
Integrated Comprehensive Opioid Use Disorder Response,
authorized at $5 million each fiscal year for fiscal years 2023
through 2027.
Sec. 222. Emergency department alternatives to opioids
Section 222 reauthorizes Emergency Department Alternatives
to Opioids Demonstration Grants, authorized at $10 million each
fiscal year for fiscal years 2023 through 2027.
SUBTITLE C--EXCELLENCE IN RECOVERY HOUSING
Sec. 231. Clarifying the role of SAMHSA in promoting the availability
of high-quality recovery housing
Section 231 requires the Secretary, acting through the
SAMHSA Assistant Secretary, to collaborate with federal
agencies and relevant stakeholders to promote the availability
of high-quality recovery housing and services for individuals
with substance use disorder.
Sec. 232. Developing guidelines for States to promote the availability
of high-quality recovery housing
Section 232 requires the Secretary to develop and
periodically update consensus based best practices for
operating, and promoting the availability of, high-quality
recovery housing.
Sec. 233. Coordination of Federal activities to promote the
availability of recovery housing
Section 233 requires the Secretary, acting through the
SAMHSA Assistant Secretary, and the Secretary of Housing and
Urban Development, to convene an interagency working group and
report to Congress on its activities to increase federal
collaboration and coordination, develop a long-term plan to
support state, Tribal, and local efforts to operate recovery
housing consistent with best practices, and coordinate fair
housing practices and data collection on the quality of
recovery housing.
Sec. 234. NAS study and report
Section 234 requires the Secretary, acting through the
Assistant Secretary for Mental Health and Substance Use, to
contract with the National Academy of Sciences, Engineering,
and Medicine to study the quality and effectiveness of recovery
housing in the United States and identify recommendations, and
to report to Congress the results of the review. This section
authorizes $1.5 million for fiscal year 2023.
Sec. 235. Grants for States to promote the availability of recovery
housing and services
Section 235 permits SAMHSA to provide grants to states,
Tribes, and territories for technical assistance to promote and
maintain recovery housing according to best practices and to
develop related state promotion plans.
Sec. 236. Funding
Section 236 reauthorizes $5 million for the period of
fiscal years 2023 through 2027 for the activities described in
sections 231 through 235.
Sec. 237. Technical correction
Section 237 makes technical conforming corrections to the
Public Health Services Act (PHSA).
SUBTITLE D--SUBSTANCE USE PREVENTION, TREATMENT, AND RECOVERY SERVICES
BLOCK GRANT
Sec. 241. Eliminating stigmatizing language relating to substance use
Section 241 renames SAMHSA's Substance Abuse Prevention and
Treatment Block Grant as the ``Substance Use Prevention,
Treatment, and Recovery Services Block Grant,'' and replaces
``substance abuse'' with ``substance use'' throughout the
program.
Sec. 242. Authorized activities
Section 242 is expanded to specify that providing recovery
support services is an authorized activity under the block
grant use of funds.
Sec. 243. Requirements relating to certain infectious diseases and
human immunodeficiency virus
Section 243 updates the basis by which states are
designated as required to provide HIV related services based on
HIV case rate rather than AIDS case rate effective fiscal year
2025. This section also requires states receiving block grant
funds to provide viral hepatitis screening and referrals to
providers whose practice includes viral hepatitis vaccination
and treatment.
Sec. 244. State plan requirements
Section 233 requires that states' plans describe the
recovery support service activities supported by block grant
funds, including the number of individuals served, target
populations, priority needs, and the amount of funds allocated
to recovery support service disaggregated by type of activity.
Sec. 245. Updating certain language relating to Tribes
Section 245 updates statutory language to recognize Tribes
and Tribal organizations as proper nouns.
Sec. 246. Block grants for substance use prevention, treatment, and
recovery services
Section 246 authorizes the Substance Use Prevention,
Treatment, and Recovery Services Block Grants at $1.908 billion
annually for fiscal years 2023 through 2027. The section also
makes a technical correction to the PHSA.
Sec. 247. Requirement of reports and audits by States
Section 247 requires states' report to include the amount
of funds provided to each grant recipient the previous fiscal
year.
Sec. 248. Study on assessment for use in distribution of limited State
resources
Section 248 requires the Secretary to conduct a study to
develop a model needs assessment process for states.
SUBTITLE E--TIMELY TREATMENT FOR OPIOID USE DISORDER
Sec. 251. Study on exemptions for treatment of opioid use disorder
through opioid treatment programs during the COVID-19 public
health emergency
Section 251 requires the Assistant Secretary for Mental
Health and Substance Use to conduct a study and report within
180 days on the impact of treatment flexibilities allowed
during the pandemic on an OTP's effectiveness and safety.
Sec. 252. Changes to Federal opioid treatment standards
Section 252 changes the federal opioid treatment standards
to allow an OTP to operate one or more mobile units to dispense
medications at locations other than the registrant's principal
place of business or professional practice under the same
registration. Previously, each mobile unit had to be separately
registered. This section eliminates the requirement that an
individual be addicted to opioids for at least one year before
being admitted for treatment by an OTP. This section also
requires the Secretary to establish criteria for OTP to allow
certain patients to receive take home medications.
SUBTITLE F--ADDITIONAL PROVISIONS RELATING TO ADDICTION TREATMENT
Sec. 261. Prohibition
Section 261 prohibits funds authorized or amended by this
Act from being used to purchase, procure, or distribute pipes
or cylindrical objects intended to be used to smoke or inhale
illegal schedule substances.
Sec. 262. Eliminating additional requirements for dispensing narcotic
drugs in schedule III, IV, and V for maintenance or
detoxification treatment
Section 262 eliminates the requirement for registered
health care practitioners to apply for a separate waiver
through the Drug Enforcement Administration to dispense certain
narcotic drugs (e.g., buprenorphine) for maintenance or
detoxification treatment.
Sec. 263. Requiring prescribers of controlled substances to complete
training
Section 263 requires health care providers, as a condition
of receiving or renewing a registration to prescribe controlled
substances, to meet a one-time eight-hour training requirement
on treating patients with substance use disorders.
TITLE III: ACCESS TO MENTAL HEALTH CARE AND COVERAGE
SUBTITLE A--COLLABORATE IN AN ORDERLY AND COHESIVE MANNER
Sec. 301. Increasing uptake of the collaborative care model
Section 301 reauthorizes a program that allows HHS to award
grants to states that partner with a community program, a
health center, a Federally Qualified Health Center or rural
health clinic, or a primary health care physician practice to
implement and evaluate specified models of care that integrate
behavioral health and primary care services. Recipients who
provide care to medically underserved populations and in areas
where the prevalence of behavioral health conditions exceeds
the national average are given priority for these grants. This
section establishes incentive payments for recipients that use
appropriate billing codes and quality measures for behavioral
health services as well as grants for national and regional
organizations that provide technical assistance to improve
integration. This section authorizes $60 million annually for
fiscal years 2023 through 2027.
SUBTITLE B--HELPING ENABLE ACCESS TO LIFESAVING SERVICES
Sec. 311. Reauthorization and provision of certain programs to
strengthen the health care workforce
Section 311 reauthorizes multiple programs to support and
strengthen the health care workforce, including Liability
Protections for Health Professional Volunteers, reauthorized
through October 1, 2027; Mental and Behavioral Health Education
and Training Grants including updates to the education
reference for occupational therapist, reauthorized at $50
million for fiscal years 2023 through 2027; and the Training
Demonstration Program, reauthorized at $37.1 million annually
for fiscal years 2023 through 2027. This section updates the
Minority Fellowship Program to include those ``in the fields of
crisis care management.''
SUBTITLE C--ELIMINATING THE OPT-OUT FOR NONFEDERAL GOVERNMENTAL HEALTH
PLANS
Sec. 321. Eliminating the opt-out for nonfederal governmental health
plans
Section 321 requires self-funded, non-federal governmental
plans to comply with mental health parity requirements starting
six months after the date of enactment or longer contingent on
the terms of the plan agreement.
SUBTITLE D--MENTAL HEALTH AND SUBSTANCE USE DISORDER PARITY
IMPLEMENTATION
Sec. 331. Grants to support mental health and substance use disorder
parity implementation
Section 331 authorizes $10 million annually for fiscal
years 2023 through 2027 for grants to states to enforce and
ensure compliance with mental health parity.
TITLE IV: CHILDREN AND YOUTH
SUBTITLE A--SUPPORTING CHILDREN'S MENTAL HEALTH CARE ACCESS
Sec. 401. Pediatric mental health care access grants
Section 401 reauthorizes HRSA's Pediatric Mental Health
Care Access grant program that promotes behavioral health
integration into pediatric primary care by supporting pediatric
mental health care telehealth access programs in states at $14
million annually for fiscal years 2023 through 2025 and $30
million annually for fiscal years 2026 through 2027.
Sec. 402. Infant and early childhood mental health promotion,
intervention, and treatment
Section 402 reauthorizes SAMHSA's Infant and Early
Childhood Mental Health Grant Program, which is intended to
improve outcomes for children from birth to age 12 by
developing, maintaining, or enhancing mental health promotion,
intervention, and treatment services at $50 million for the
period of fiscal years 2023 through 2027.
SUBTITLE B--CONTINUING SYSTEMS OF CARE FOR CHILDREN
Sec. 411. Comprehensive Community Mental Health Services for Children
with Serious Emotional Disturbances
Section 411 reauthorizes the Comprehensive Community Mental
Health Services for Children with Serious Emotional
Disturbances Grants, maintaining the existing program structure
with the exception of redefining ``parents or kinship
caregivers,'' authorized at $125 million annually for fiscal
years 2023 through 2027.
Sec. 412. Substance Use Disorder Treatment and Early Intervention
Services for Children and Adolescents
Section 412 reauthorizes the Enhancement and Expansion of
Treatment and Recovery Services for Adolescents, Transitional
Aged Youth, and their Families (Youth and Family TREE) Grants
at $29.605 million annually for fiscal years 2023 through 2027.
SUBTITLE C--GARRETT LEE SMITH MEMORIAL REAUTHORIZATION
Sec. 421. Suicide prevention technical assistance center
Section 421 reauthorizes the Suicide Prevention Resource
Center at $9 million annually for fiscal years 2023 through
2027.
Sec. 422. Youth suicide early intervention and prevention strategies
Section 422 reauthorizes the State and Tribal Youth Suicide
Prevention and Early Intervention Grants Program at $40 million
annually for fiscal years 2023 through 2027 and provides the
allowable use of funds for supplies to securely store commonly
used means of suicide within a household.
Sec. 423. Mental health and substance use disorder services for
students in higher education
Section 423 reauthorizes the Mental Health Youth Suicide
Prevention Campus Grants at $7 million for each fiscal year for
fiscal years 2023 through 2027.
Sec. 424. Mental and behavioral health outreach and education at
institutions of higher education
Section 424 reauthorizes and renames the Mental and
Behavioral Health Public Outreach and Education at Institutions
of Higher Education program at $1 million for fiscal years 2023
through 2027 and specifies that representatives from minority-
serving institutions and community colleges be included on the
program's working group.
XVI. Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE II--ADMINISTRATION AND MISCELLANEOUS PROVISIONS
Part A--Administration
* * * * * * *
defense of certain malpractice and negligence suits
Sec. 224. (a) The remedy against the United States provided
by sections 1346(b) and 2672 of title 28, or by alternative
benefits provided by the United States where the availability
of such benefits precludes a remedy under section 1346(b) of
title 28, for damage for personal injury, including death,
resulting from the performance of medical, surgical, dental, or
related functions, including the conduct of clinical studies or
investigation, by any commissioned officer or employee of the
Public Health Service while acting within the scope of his
office or employment, shall be exclusive of any other civil
action or proceeding by reason of the same subject-matter
against the officer or employee (or his estate) whose act or
omission gave rise to the claim.
(b) The Attorney General shall defend any civil action or
proceeding brought in any court against any person referred to
in subsection (a) of this section (or his estate) for any such
damage or injury. Any such person against whom such civil
action or proceeding is brought shall deliver within such time
after date of service or knowledge of service as determined by
the Attorney General, all process served upon him or an
attested true copy thereof to his immediate superior or to
whomever was designated by the Secretary to receive such papers
and such persons shall promptly furnish copies of the pleading
and process therein to the United States attorney for the
district embracing the place wherein the proceeding is brought,
to the Attorney General, and to the Secretary.
(c) Upon a certification by the Attorney General that the
defendant was acting in the scope of his employment at the time
of the incident out of which the suit arose, any such civil
action or proceeding commenced in a State court shall be
removed without bond at any time before trial by the Attorney
General to the district court of the United States of the
district and division embracing the place wherein it is pending
and the proceeding deemed a tort action brought against the
United States under the provisions of title 28 and all
references thereto. Should a United States district court
determine on a hearing on a motion to remand held before a
trial on the merit that the case so removed is one in which a
remedy by suit within the meaning of subsection (a) of this
section is not available against the United States, the case
shall be remanded to the State Court: Provided, That where such
a remedy is precluded because of the availability of a remedy
through proceedings for compensation or other benefits from the
United States as provided by any other law, the case shall be
dismissed, but in the event the running of any limitation of
time for commencing, or filing an application or claim in, such
proceedings for compensation or other benefits shall be deemed
to have been suspended during the pendency of the civil action
or proceeding under this section.
(d) The Attorney General may compromise or settle any claim
asserted in such civil action or proceeding in the manner
provided in section 2677 of title 28 and with the same effect.
(e) For purposes of this section, the provisions of section
2680(h) of title 28 shall not apply to assault or battery
arising out of negligence in the performance of medical,
surgical, dental, or related functions, including the conduct
of clinical studies or investigations.
(f) The Secretary or his designee may, to the extent that he
deems appropriate, hold harmless or provide liability insurance
for any officer or employee of the Public Health Service for
damage for personal injury, including death, negligently caused
by such officer or employee while acting within the scope of
his office or employment and as a result of the performance of
medical, surgical, dental, or related functions, including the
conduct of clinical studies or investigations, if such employee
is assigned to a foreign country or detailed to a State or
political subdivision thereof or to a non-profit institution,
and if the circumstances are such as are likely to preclude the
remedies of third persons against the United States described
in section 2679(b) of title 28, for such damage or injury.
(g)(1)(A) For purposes of this section and subject to the
approval by the Secretary of an application under subparagraph
(D), an entity described in paragraph (4), and any officer,
governing board member, or employee of such an entity, and any
contractor of such an entity who is a physician or other
licensed or certified health care practitioner (subject to
paragraph (5)), shall be deemed to be an employee of the Public
Health Service for a calendar year that begins during a fiscal
year for which a transfer was made under subsection (k)(3)
(subject to paragraph (3)). The remedy against the United
States for an entity described in paragraph (4) and any
officer, governing board member, employee, or contractor
(subject to paragraph (5)) of such an entity who is deemed to
be an employee of the Public Health Service pursuant to this
paragraph shall be exclusive of any other civil action or
proceeding to the same extent as the remedy against the United
States is exclusive pursuant to subsection (a).
(B) The deeming of any entity or officer, governing board
member, employee, or contractor of the entity to be an employee
of the Public Health Service for purposes of this section shall
apply with respect to services provided--
(i) to all patients of the entity, and
(ii) subject to subparagraph (C), to individuals who
are not patients of the entity.
(C) Subparagraph (B)(ii) applies to services provided to
individuals who are not patients of an entity if the Secretary
determines, after reviewing an application submitted under
subparagraph (D), that the provision of the services to such
individuals--
(i) benefits patients of the entity and general
populations that could be served by the entity through
community-wide intervention efforts within the
communities served by such entity;
(ii) facilitates the provision of services to
patients of the entity; or
(iii) are otherwise required under an employment
contract (or similar arrangement) between the entity
and an officer, governing board member, employee, or
contractor of the entity.
(D) The Secretary may not under subparagraph (A) deem an
entity or an officer, governing board member, employee, or
contractor of the entity to be an employee of the Public Health
Service for purposes of this section, and may not apply such
deeming to services described in subparagraph (B)(ii), unless
the entity has submitted an application for such deeming to the
Secretary in such form and such manner as the Secretary shall
prescribe. The application shall contain detailed information,
along with supporting documentation, to verify that the entity,
and the officer, governing board member, employee, or
contractor of the entity, as the case may be, meets the
requirements of subparagraphs (B) and (C) of this paragraph and
that the entity meets the requirements of paragraphs (1)
through (4) of subsection (h).
(E) The Secretary shall make a determination of whether an
entity or an officer, governing board member, employee, or
contractor of the entity is deemed to be an employee of the
Public Health Service for purposes of this section within 30
days after the receipt of an application under subparagraph
(D). The determination of the Secretary that an entity or an
officer, governing board member, employee, or contractor of the
entity is deemed to be an employee of the Public Health Service
for purposes of this section shall apply for the period
specified by the Secretary under subparagraph (A).
(F) Once the Secretary makes a determination that an entity
or an officer, governing board member, employee, or contractor
of an entity is deemed to be an employee of the Public Health
Service for purposes of this section, the determination shall
be final and binding upon the Secretary and the Attorney
General and other parties to any civil action or proceeding.
Except as provided in subsection (i), the Secretary and the
Attorney General may not determine that the provision of
services which are the subject of such a determination are not
covered under this section.
(G) In the case of an entity described in paragraph (4) that
has not submitted an application under subparagraph (D):
(i) The Secretary may not consider the entity in
making estimates under subsection (k)(1).
(ii) This section does not affect any authority of
the entity to purchase medical malpractice liability
insurance coverage with Federal funds provided to the
entity under section 329, 330, or 340A.
(H) In the case of an entity described in paragraph (4) for
which an application under subparagraph (D) is in effect, the
entity may, through notifying the Secretary in writing, elect
to terminate the applicability of this subsection to the
entity. With respect to such election by the entity:
(i) The election is effective upon the expiration of
the 30-day period beginning on the date on which the
entity submits such notification.
(ii) Upon taking effect, the election terminates the
applicability of this subsection to the entity and each
officer, governing board member, employee, and
contractor of the entity.
(iii) Upon the effective date for the election,
clauses (i) and (ii) of subparagraph (G) apply to the
entity to the same extent and in the same manner as
such clauses apply to an entity that has not submitted
an application under subparagraph (D).
(iv) If after making the election the entity submits
an application under subparagraph (D), the election
does not preclude the Secretary from approving the
application (and thereby restoring the applicability of
this subsection to the entity and each officer,
governing board member, employee, and contractor of the
entity, subject to the provisions of this subsection
and the subsequent provisions of this section.
(2) If, with respect to an entity or person deemed to be an
employee for purposes of paragraph (1), a cause of action is
instituted against the United States pursuant to this section,
any claim of the entity or person for benefits under an
insurance policy with respect to medical malpractice relating
to such cause of action shall be subrogated to the United
States.
(3) This subsection shall apply with respect to a cause of
action arising from an act or omission which occurs on or after
January 1, 1993.
(4) An entity described in this paragraph is a public or non-
profit private entity receiving Federal funds under section
330.
(5) For purposes of paragraph (1), an individual may be
considered a contractor of an entity described in paragraph (4)
only if--
(A) the individual normally performs on average at
least 32\1/2\ hours of service per week for the entity
for the period of the contract; or
(B) in the case of an individual who normally
performs an average of less than 32\1/2\ hours of
services per week for the entity for the period of the
contract, the individual is a licensed or certified
provider of services in the fields of family practice,
general internal medicine, general pediatrics, or
obstetrics and gynecology.
(h) The Secretary may not approve an application under
subsection (g)(1)(D) unless the Secretary determines that the
entity--
(1) has implemented appropriate policies and
procedures to reduce the risk of malpractice and the
risk of lawsuits arising out of any health or health-
related functions performed by the entity;
(2) has reviewed and verified the professional
credentials, references, claims history, fitness,
professional review organization findings, and license
status of its physicians and other licensed or
certified health care practitioners, and, where
necessary, has obtained the permission from these
individuals to gain access to this information;
(3) has no history of claims having been filed
against the United States as a result of the
application of this section to the entity or its
officers, employees, or contractors as provided for
under this section, or, if such a history exists, has
fully cooperated with the Attorney General in defending
against any such claims and either has taken, or will
take, any necessary corrective steps to assure against
such claims in the future; and
(4) will fully cooperate with the Attorney General in
providing information relating to an estimate described
under subsection (k).
(i)(1) Notwithstanding subsection (g)(1), the Attorney
General, in consultation with the Secretary, may on the record
determine, after notice and opportunity for a full and fair
hearing, that an individual physician or other licensed or
certified health care practitioner who is an officer, employee,
or contractor of an entity described in subsection (g)(4) shall
not be deemed to be an employee of the Public Health Service
for purposes of this section, if treating such individual as
such an employee would expose the Government to an unreasonably
high degree of risk of loss because such individual--
(A) does not comply with the policies and procedures
that the entity has implemented pursuant to subsection
(h)(1);
(B) has a history of claims filed against him or her
as provided for under this section that is outside the
norm for licensed or certified health care
practitioners within the same specialty;
(C) refused to reasonably cooperate with the Attorney
General in defending against any such claim;
(D) provided false information relevant to the
individual's performance of his or her duties to the
Secretary, the Attorney General, or an applicant for or
recipient of funds under this Act; or
(E) was the subject of disciplinary action taken by a
State medical licensing authority or a State or
national professional society.
(2) A final determination by the Attorney General under this
subsection that an individual physician or other licensed or
certified health care professional shall not be deemed to be an
employee of the Public Health Service shall be effective upon
receipt by the entity employing such individual of notice of
such determination, and shall apply only to acts or omissions
occurring after the date such notice is received.
(j) In the case of a health care provider who is an officer,
employee, or contractor of an entity described in subsection
(g)(4), section 335(e) shall apply with respect to the provider
to the same extent and in the same manner as such section
applies to any member of the National Health Service Corps.
(k)(1)(A) For each fiscal year, the Attorney General, in
consultation with the Secretary, shall estimate by the
beginning of the year the amount of all claims which are
expected to arise under this section (together with related
fees and expenses of witnesses) for which payment is expected
to be made in accordance with section 1346 and chapter 171 of
title 28, United States Code, from the acts or omissions,
during the calendar year that begins during that fiscal year,
of entities described in subsection (g)(4) and of officers,
employees, or contractors (subject to subsection (g)(5)) of
such entities.
(B) The estimate under subparagraph (A) shall take into
account--
(i) the value and frequency of all claims for damage
for personal injury, including death, resulting from
the performance of medical, surgical, dental, or
related functions by entities described in subsection
(g)(4) or by officers, employees, or contractors
(subject to subsection (g)(5)) of such entities who are
deemed to be employees of the Public Health Service
under subsection (g)(1) that, during the preceding 5-
year period, are filed under this section or, with
respect to years occurring before this subsection takes
effect, are filed against persons other than the United
States,
(ii) the amounts paid during that 5-year period on
all claims described in clause (i), regardless of when
such claims were filed, adjusted to reflect payments
which would not be permitted under section 1346 and
chapter 171 of title 28, United States Code, and
(iii) amounts in the fund established under paragraph
(2) but unspent from prior fiscal years.
(2) Subject to appropriations, for each fiscal year, the
Secretary shall establish a fund of an amount equal to the
amount estimated under paragraph (1) that is attributable to
entities receiving funds under each of the grant programs
described in paragraph (4) of subsection (g), but not to exceed
a total of $10,000,000 for each such fiscal year.
Appropriations for purposes of this paragraph shall be made
separate from appropriations made for purposes of sections 329,
330 and 340A.
(3) In order for payments to be made for judgments against
the United States (together with related fees and expenses of
witnesses) pursuant to this section arising from the acts or
omissions of entities described in subsection (g)(4) and of
officers, employees, or contractors (subject to subsection
(g)(5)) of such entities, the total amount contained within the
fund established by the Secretary under paragraph (2) for a
fiscal year shall be transferred not later than the December 31
that occurs during the fiscal year to the appropriate accounts
in the Treasury.
(l)(1) If a civil action or proceeding is filed in a State
court against any entity described in subsection (g)(4) or any
officer, governing board member, employee, or any contractor of
such an entity for damages described in subsection (a), the
Attorney General, within 15 days after being notified of such
filing, shall make an appearance in such court and advise such
court as to whether the Secretary has determined under
subsections (g) and (h), that such entity, officer, governing
board member, employee, or contractor of the entity is deemed
to be an employee of the Public Health Service for purposes of
this section with respect to the actions or omissions that are
the subject of such civil action or proceeding. Such advice
shall be deemed to satisfy the provisions of subsection (c)
that the Attorney General certify that an entity, officer,
governing board member, employee, or contractor of the entity
was acting within the scope of their employment or
responsibility.
(2) If the Attorney General fails to appear in State court
within the time period prescribed under paragraph (1), upon
petition of any entity or officer, governing board member,
employee, or contractor of the entity named, the civil action
or proceeding shall be removed to the appropriate United States
district court. The civil action or proceeding shall be stayed
in such court until such court conducts a hearing, and makes a
determination, as to the appropriate forum or procedure for the
assertion of the claim for damages described in subsection (a)
and issues an order consistent with such determination.
(m)(1) An entity or officer, governing board member,
employee, or contractor of an entity described in subsection
(g)(1) shall, for purposes of this section, be deemed to be an
employee of the Public Health Service with respect to services
provided to individuals who are enrollees of a managed care
plan if the entity contracts with such managed care plan for
the provision of services.
(2) Each managed care plan which enters into a contract with
an entity described in subsection (g)(4) shall deem the entity
and any officer, governing board member, employee, or
contractor of the entity as meeting whatever malpractice
coverage requirements such plan may require of contracting
providers for a calendar year if such entity or officer,
governing board member, employee, or contractor of the entity
has been deemed to be an employee of the Public Health Service
for purposes of this section for such calendar year. Any plan
which is found by the Secretary on the record, after notice and
an opportunity for a full and fair hearing, to have violated
this subsection shall upon such finding cease, for a period to
be determined by the Secretary, to receive and to be eligible
to receive any Federal funds under titles XVIII or XIX of the
Social Security Act.
(3) For purposes of this subsection, the term ``managed care
plan'' shall mean health maintenance organizations and similar
entities that contract at-risk with payors for the provision of
health services or plan enrollees and which contract with
providers (such as entities described in subsection (g)(4)) for
the delivery of such services to plan enrollees.
(n)(1) Not later than one year after the date of the
enactment of the Federally Supported Health Centers Assistance
Act of 1995, the Comptroller General of the United States shall
submit to the Congress a report on the following:
(A) The medical malpractice liability claims
experience of entities that have been deemed to be
employees for purposes of this section.
(B) The risk exposure of such entities.
(C) The value of private sector risk-management
services, and the value of risk-management services and
procedures required as a condition of receiving a grant
under section 329, 330, or 340A.
(D) A comparison of the costs and the benefits to
taxpayers of maintaining medical malpractice liability
coverage for such entities pursuant to this section,
taking into account--
(i) a comparison of the costs of premiums
paid by such entities for private medical
malpractice liability insurance with the cost
of coverage pursuant to this section; and
(ii) an analysis of whether the cost of
premiums for private medical malpractice
liability insurance coverage is consistent with
the liability claims experience of such
entities.
(2) The report under paragraph (1) shall include the
following:
(A) A comparison of--
(i) an estimate of the aggregate amounts that
such entities (together with the officers,
governing board members, employees, and
contractors of such entities who have been
deemed to be employees for purposes of this
section) would have directly or indirectly paid
in premiums to obtain medical malpractice
liability insurance coverage if this section
were not in effect; with
(ii) the aggregate amounts by which the
grants received by such entities under this Act
were reduced pursuant to subsection (k)(2).
(B) A comparison of--
(i) an estimate of the amount of privately
offered such insurance that such entities
(together with the officers, governing board
members, employees, and contractors of such
entities who have been deemed to be employees
for purposes of this section) purchased during
the three-year period beginning on January 1,
1993; with
(ii) an estimate of the amount of such
insurance that such entities (together with the
officers, governing board members, employees,
and contractors of such entities who have been
deemed to be employees for purposes of this
section) will purchase after the date of the
enactment of the Federally Supported Health
Centers Assistance Act of 1995.
(C) An estimate of the medical malpractice liability
loss history of such entities for the 10-year period
preceding October 1, 1996, including but not limited to
the following:
(i) Claims that have been paid and that are
estimated to be paid, and legal expenses to
handle such claims that have been paid and that
are estimated to be paid, by the Federal
Government pursuant to deeming entities as
employees for purposes of this section.
(ii) Claims that have been paid and that are
estimated to be paid, and legal expenses to
handle such claims that have been paid and that
are estimated to be paid, by private medical
malpractice liability insurance.
(D) An analysis of whether the cost of premiums for
private medical malpractice liability insurance
coverage is consistent with the liability claims
experience of entities that have been deemed as
employees for purposes of this section.
(3) In preparing the report under paragraph (1), the
Comptroller General of the United States shall consult with
public and private entities with expertise on the matters with
which the report is concerned.
(o)(1) For purposes of this section, a free clinic health
professional shall in providing a qualifying health service to
an individual, or an officer, governing board member, employee,
or contractor of a free clinic shall in providing services for
the free clinic, be deemed to be an employee of the Public
Health Service for a calendar year that begins during a fiscal
year for which a transfer was made under paragraph (6)(D). The
preceding sentence is subject to the provisions of this
subsection.
(2) In providing a health service to an individual, a health
care practitioner shall for purposes of this subsection be
considered to be a free clinic health professional if the
following conditions are met:
(A) The service is provided to the individual at a
free clinic, or through offsite programs or events
carried out by the free clinic.
(B) The free clinic is sponsoring the health care
practitioner pursuant to paragraph (5)(C).
(C) The service is a qualifying health service (as
defined in paragraph (4)).
(D) Neither the health care practitioner nor the free
clinic receives any compensation for the service from
the individual or from any third-party payor (including
reimbursement under any insurance policy or health
plan, or under any Federal or State health benefits
program). With respect to compliance with such
condition:
(i) The health care practitioner may receive
repayment from the free clinic for reasonable
expenses incurred by the health care
practitioner in the provision of the service to
the individual.
(ii) The free clinic may accept voluntary
donations for the provision of the service by
the health care practitioner to the individual.
(E) Before the service is provided, the health care
practitioner or the free clinic provides written notice
to the individual of the extent to which the legal
liability of the health care practitioner is limited
pursuant to this subsection (or in the case of an
emergency, the written notice is provided to the
individual as soon after the emergency as is
practicable). If the individual is a minor or is
otherwise legally incompetent, the condition under this
subparagraph is that the written notice be provided to
a legal guardian or other person with legal
responsibility for the care of the individual.
(F) At the time the service is provided, the health
care practitioner is licensed or certified in
accordance with applicable law regarding the provision
of the service.
(3)(A) For purposes of this subsection, the term ``free
clinic'' means a health care facility operated by a nonprofit
private entity meeting the following requirements:
(i) The entity does not, in providing health services
through the facility, accept reimbursement from any
third-party payor (including reimbursement under any
insurance policy or health plan, or under any Federal
or State health benefits program).
(ii) The entity, in providing health services through
the facility, either does not impose charges on the
individuals to whom the services are provided, or
imposes a charge according to the ability of the
individual involved to pay the charge.
(iii) The entity is licensed or certified in
accordance with applicable law regarding the provision
of health services.
(B) With respect to compliance with the conditions under
subparagraph (A), the entity involved may accept voluntary
donations for the provision of services.
(4) For purposes of this subsection, the term ``qualifying
health service'' means any medical assistance required or
authorized to be provided in the program under title XIX of the
Social Security Act, without regard to whether the medical
assistance is included in the plan submitted under such program
by the State in which the health care practitioner involved
provides the medical assistance. References in the preceding
sentence to such program shall as applicable be considered to
be references to any successor to such program.
(5) Subsection (g) (other than paragraphs (3) through (5))
and subsections (h), (i), and (l) apply to a health care
practitioner for purposes of this subsection to the same extent
and in the same manner as such subsections apply to an officer,
governing board member, employee, or contractor of an entity
described in subsection (g)(4), subject to paragraph (6) and
subject to the following:
(A) The first sentence of paragraph (1) applies in
lieu of the first sentence of subsection (g)(1)(A).
(B) This subsection may not be construed as deeming
any free clinic to be an employee of the Public Health
Service for purposes of this section.
(C) With respect to a free clinic, a health care
practitioner is not a free clinic health professional
unless the free clinic sponsors the health care
practitioner. For purposes of this subsection, the free
clinic shall be considered to be sponsoring the health
care practitioner if--
(i) with respect to the health care
practitioner, the free clinic submits to the
Secretary an application meeting the
requirements of subsection (g)(1)(D); and
(ii) the Secretary, pursuant to subsection
(g)(1)(E), determines that the health care
practitioner is deemed to be an employee of the
Public Health Service.
(D) In the case of a health care practitioner who is
determined by the Secretary pursuant to subsection
(g)(1)(E) to be a free clinic health professional, this
subsection applies to the health care practitioner
(with respect to the free clinic sponsoring the health
care practitioner pursuant to subparagraph (C)) for any
cause of action arising from an act or omission of the
health care practitioner occurring on or after the date
on which the Secretary makes such determination.
(E) Subsection (g)(1)(F) applies to a health care
practitioner for purposes of this subsection only to
the extent that, in providing health services to an
individual, each of the conditions specified in
paragraph (2) is met.
(6)(A) For purposes of making payments for judgments against
the United States (together with related fees and expenses of
witnesses) pursuant to this section arising from the acts or
omissions of free clinic health professionals, there is
authorized to be appropriated $10,000,000 for each fiscal year.
(B) The Secretary shall establish a fund for purposes of this
subsection. Each fiscal year amounts appropriated under
subparagraph (A) shall be deposited in such fund.
(C) Not later than May 1 of each fiscal year, the Attorney
General, in consultation with the Secretary, shall submit to
the Congress a report providing an estimate of the amount of
claims (together with related fees and expenses of witnesses)
that, by reason of the acts or omissions of free clinic health
professionals, will be paid pursuant to this section during the
calendar year that begins in the following fiscal year.
Subsection (k)(1)(B) applies to the estimate under the
preceding sentence regarding free clinic health professionals
to the same extent and in the same manner as such subsection
applies to the estimate under such subsection regarding
officers, governing board members, employees, and contractors
of entities described in subsection (g)(4).
(D) Not later than December 31 of each fiscal year, the
Secretary shall transfer from the fund under subparagraph (B)
to the appropriate accounts in the Treasury an amount equal to
the estimate made under subparagraph (C) for the calendar year
beginning in such fiscal year, subject to the extent of amounts
in the fund.
(7)(A) This subsection takes effect on the date of the
enactment of the first appropriations Act that makes an
appropriation under paragraph (6)(A), except as provided in
subparagraph (B)(i).
(B)(i) Effective on the date of the enactment of the Health
Insurance Portability and Accountability Act of 1996--
(I) the Secretary may issue regulations for carrying
out this subsection, and the Secretary may accept and
consider applications submitted pursuant to paragraph
(5)(C); and
(II) reports under paragraph (6)(C) may be submitted
to the Congress.
(ii) For the first fiscal year for which an appropriation is
made under subparagraph (A) of paragraph (6), if an estimate
under subparagraph (C) of such paragraph has not been made for
the calendar year beginning in such fiscal year, the transfer
under subparagraph (D) of such paragraph shall be made
notwithstanding the lack of the estimate, and the transfer
shall be made in an amount equal to the amount of such
appropriation.
(p) Administration of Smallpox Countermeasures by Health
Professionals.--
(1) In general.--For purposes of this section, and
subject to other provisions of this subsection, a
covered person shall be deemed to be an employee of the
Public Health Service with respect to liability arising
out of administration of a covered countermeasure
against smallpox to an individual during the effective
period of a declaration by the Secretary under
paragraph (2)(A).
(2) Declaration by secretary concerning
countermeasure against smallpox.--
(A) Authority to issue declaration.--
(i) In general.--The Secretary may
issue a declaration, pursuant to this
paragraph, concluding that an actual or
potential bioterrorist incident or
other actual or potential public health
emergency makes advisable the
administration of a covered
countermeasure to a category or
categories of individuals.
(ii) Covered countermeasure.--The
Secretary shall specify in such
declaration the substance or substances
that shall be considered covered
countermeasures (as defined in
paragraph (7)(A)) for purposes of
administration to individuals during
the effective period of the
declaration.
(iii) Effective period.--The
Secretary shall specify in such
declaration the beginning and ending
dates of the effective period of the
declaration, and may subsequently amend
such declaration to shorten or extend
such effective period, provided that
the new closing date is after the date
when the declaration is amended.
(iv) Publication.--The Secretary
shall promptly publish each such
declaration and amendment in the
Federal Register.
(B) Liability of united states only for
administrations within scope of declaration.--
Except as provided in paragraph (5)(B)(ii), the
United States shall be liable under this
subsection with respect to a claim arising out
of the administration of a covered
countermeasure to an individual only if--
(i) the countermeasure was
administered by a qualified person, for
a purpose stated in paragraph
(7)(A)(i), and during the effective
period of a declaration by the
Secretary under subparagraph (A) with
respect to such countermeasure; and
(ii)(I) the individual was within a
category of individuals covered by the
declaration; or
(II) the qualified person
administering the countermeasure had
reasonable grounds to believe that such
individual was within such category.
(C) Presumption of administration within
scope of declaration in case of accidental
vaccinia inoculation.--
(i) In general.--If vaccinia vaccine
is a covered countermeasure specified
in a declaration under subparagraph
(A), and an individual to whom the
vaccinia vaccine is not administered
contracts vaccinia, then, under the
circumstances specified in clause (ii),
the individual--
(I) shall be rebuttably
presumed to have contracted
vaccinia from an individual to
whom such vaccine was
administered as provided by
clauses (i) and (ii) of
subparagraph (B); and
(II) shall (unless such
presumption is rebutted) be
deemed for purposes of this
subsection to be an individual
to whom a covered
countermeasure was administered
by a qualified person in
accordance with the terms of
such declaration and as
described by subparagraph (B).
(ii) Circumstances in which
presumption applies.--The presumption
and deeming stated in clause (i) shall
apply if--
(I) the individual contracts
vaccinia during the effective
period of a declaration under
subparagraph (A) or by the date
30 days after the close of such
period; or
(II) the individual has
resided with, or has had
contact with, an individual to
whom such vaccine was
administered as provided by
clauses (i) and (ii) of
subparagraph (B) and contracts
vaccinia after such date.
(D) Acts and omissions deemed to be within
scope of employment.--
(i) In general.--In the case of a
claim arising out of alleged
transmission of vaccinia from an
individual described in clause (ii),
acts or omissions by such individual
shall be deemed to have been taken
within the scope of such individual's
office or employment for purposes of--
(I) subsection (a); and
(II) section 1346(b) and
chapter 171 of title 28, United
States Code.
(ii) Individuals to whom deeming
applies.--An individual is described by
this clause if--
(I) vaccinia vaccine was
administered to such individual
as provided by subparagraph
(B); and
(II) such individual was
within a category of
individuals covered by a
declaration under subparagraph
(A)(i).
(3) Exhaustion; exclusivity; offset.--
(A) Exhaustion.--
(i) In general.--A person may not
bring a claim under this subsection
unless such person has exhausted such
remedies as are available under part C
of this title, except that if the
Secretary fails to make a final
determination on a request for benefits
or compensation filed in accordance
with the requirements of such part
within 240 days after such request was
filed, the individual may seek any
remedy that may be available under this
section.
(ii) Tolling of statute of
limitations.--The time limit for filing
a claim under this subsection, or for
filing an action based on such claim,
shall be tolled during the pendency of
a request for benefits or compensation
under part C of this title.
(iii) Construction.--This subsection
shall not be construed as superseding
or otherwise affecting the application
of a requirement, under chapter 171 of
title 28, United States Code, to
exhaust administrative remedies.
(B) Exclusivity.--The remedy provided by
subsection (a) shall be exclusive of any other
civil action or proceeding for any claim or
suit this subsection encompasses, except for a
proceeding under part C of this title.
(C) Offset.--The value of all compensation
and benefits provided under part C of this
title for an incident or series of incidents
shall be offset against the amount of an award,
compromise, or settlement of money damages in a
claim or suit under this subsection based on
the same incident or series of incidents.
(4) Certification of action by attorney general.--
Subsection (c) applies to actions under this
subsection, subject to the following provisions:
(A) Nature of certification.--The
certification by the Attorney General that is
the basis for deeming an action or proceeding
to be against the United States, and for
removing an action or proceeding from a State
court, is a certification that the action or
proceeding is against a covered person and is
based upon a claim alleging personal injury or
death arising out of the administration of a
covered countermeasure.
(B) Certification of attorney general
conclusive.--The certification of the Attorney
General of the facts specified in subparagraph
(A) shall conclusively establish such facts for
purposes of jurisdiction pursuant to this
subsection.
(5) Covered person to cooperate with united states.--
(A) In general.--A covered person shall
cooperate with the United States in the
processing and defense of a claim or action
under this subsection based upon alleged acts
or omissions of such person.
(B) Consequences of failure to cooperate.--
Upon the motion of the United States or any
other party and upon finding that such person
has failed to so cooperate--
(i) the court shall substitute such
person as the party defendant in place
of the United States and, upon motion,
shall remand any such suit to the court
in which it was instituted if it
appears that the court lacks subject
matter jurisdiction;
(ii) the United States shall not be
liable based on the acts or omissions
of such person; and
(iii) the Attorney General shall not
be obligated to defend such action.
(6) Recourse against covered person in case of gross
misconduct or contract violation.--
(A) In general.--Should payment be made by
the United States to any claimant bringing a
claim under this subsection, either by way of
administrative determination, settlement, or
court judgment, the United States shall have,
notwithstanding any provision of State law, the
right to recover for that portion of the
damages so awarded or paid, as well as interest
and any costs of litigation, resulting from the
failure of any covered person to carry out any
obligation or responsibility assumed by such
person under a contract with the United States
or from any grossly negligent, reckless, or
illegal conduct or willful misconduct on the
part of such person.
(B) Venue.--The United States may maintain an
action under this paragraph against such person
in the district court of the United States in
which such person resides or has its principal
place of business.
(7) Definitions.--As used in this subsection, terms
have the following meanings:
(A) Covered countermeasure.--The term
``covered countermeasure'' or ``covered
countermeasure against smallpox'', means a
substance that is--
(i)(I) used to prevent or treat
smallpox (including the vaccinia or
another vaccine); or
(II) used to control or treat
the adverse effects of vaccinia
inoculation or of
administration of another
covered countermeasure; and
(ii) specified in a declaration under
paragraph (2).
(B) Covered person.--The term ``covered
person'', when used with respect to the
administration of a covered countermeasure,
means a person who is--
(i) a manufacturer or distributor of
such countermeasure;
(ii) a health care entity under whose
auspices--
(I) such countermeasure was
administered;
(II) a determination was made
as to whether, or under what
circumstances, an individual
should receive a covered
countermeasure;
(III) the immediate site of
administration on the body of a
covered countermeasure was
monitored, managed, or cared
for; or
(IV) an evaluation was made
of whether the administration
of a countermeasure was
effective;
(iii) a qualified person who
administered such countermeasure;
(iv) a State, a political subdivision
of a State, or an agency or official of
a State or of such a political
subdivision, if such State,
subdivision, agency, or official has
established requirements, provided
policy guidance, supplied technical or
scientific advice or assistance, or
otherwise supervised or administered a
program with respect to administration
of such countermeasures;
(v) in the case of a claim arising
out of alleged transmission of vaccinia
from an individual--
(I) the individual who
allegedly transmitted the
vaccinia, if vaccinia vaccine
was administered to such
individual as provided by
paragraph (2)(B) and such
individual was within a
category of individuals covered
by a declaration under
paragraph (2)(A)(i); or
(II) an entity that employs
an individual described by
clause (I) or where such
individual has privileges or is
otherwise authorized to provide
health care;
(vi) an official, agent, or employee
of a person described in clause (i),
(ii), (iii), or (iv);
(vii) a contractor of, or a volunteer
working for, a person described in
clause (i), (ii), or (iv), if the
contractor or volunteer performs a
function for which a person described
in clause (i), (ii), or (iv) is a
covered person; or
(viii) an individual who has
privileges or is otherwise authorized
to provide health care under the
auspices of an entity described in
clause (ii) or (v)(II).
(C) Qualified person.--The term ``qualified
person'', when used with respect to the
administration of a covered countermeasure,
means a licensed health professional or other
individual who--
(i) is authorized to administer such
countermeasure under the law of the
State in which the countermeasure was
administered; or
(ii) is otherwise authorized by the
Secretary to administer such
countermeasure.
(D) Arising out of administration of a
covered countermeasure.--The term ``arising out
of administration of a covered
countermeasure'', when used with respect to a
claim or liability, includes a claim or
liability arising out of--
(i) determining whether, or under
what conditions, an individual should
receive a covered countermeasure;
(ii) obtaining informed consent of an
individual to the administration of a
covered countermeasure;
(iii) monitoring, management, or care
of an immediate site of administration
on the body of a covered
countermeasure, or evaluation of
whether the administration of the
countermeasure has been effective; or
(iv) transmission of vaccinia virus
by an individual to whom vaccinia
vaccine was administered as provided by
paragraph (2)(B).
(q)(1) For purposes of this section, a health professional
volunteer at a deemed entity described in subsection (g)(4)
shall, in providing a health professional service eligible for
funding under section 330 to an individual, be deemed to be an
employee of the Public Health Service for a calendar year that
begins during a fiscal year for which a transfer was made under
paragraph (4)(C). The preceding sentence is subject to the
provisions of this subsection.
(2) In providing a health service to an individual, a health
care practitioner shall for purposes of this subsection be
considered to be a health professional volunteer at an entity
described in subsection (g)(4) if the following conditions are
met:
(A) The service is provided to the individual at the
facilities of an entity described in subsection (g)(4),
or through offsite programs or events carried out by
the entity.
(B) The entity is sponsoring the health care
practitioner pursuant to paragraph (3)(B).
(C) The health care practitioner does not receive any
compensation for the service from the individual, the
entity described in subsection (g)(4), or any third-
party payer (including reimbursement under any
insurance policy or health plan, or under any Federal
or State health benefits program), except that the
health care practitioner may receive repayment from the
entity described in subsection (g)(4) for reasonable
expenses incurred by the health care practitioner in
the provision of the service to the individual, which
may include travel expenses to or from the site of
services.
(D) Before the service is provided, the health care
practitioner or the entity described in subsection
(g)(4) posts a clear and conspicuous notice at the site
where the service is provided of the extent to which
the legal liability of the health care practitioner is
limited pursuant to this subsection.
(E) At the time the service is provided, the health
care practitioner is licensed or certified in
accordance with applicable Federal and State laws
regarding the provision of the service.
(F) At the time the service is provided, the entity
described in subsection (g)(4) maintains relevant
documentation certifying that the health care
practitioner meets the requirements of this subsection.
(3) Subsection (g) (other than paragraphs (3) and (5)) and
subsections (h), (i), and (l) apply to a health care
practitioner for purposes of this subsection to the same extent
and in the same manner as such subsections apply to an officer,
governing board member, employee, or contractor of an entity
described in subsection (g)(4), subject to paragraph (4), and
subject to the following:
(A) The first sentence of paragraph (1) applies in
lieu of the first sentence of subsection (g)(1)(A).
(B) With respect to an entity described in subsection
(g)(4), a health care practitioner is not a health
professional volunteer at such entity unless the entity
sponsors the health care practitioner. For purposes of
this subsection, the entity shall be considered to be
sponsoring the health care practitioner if--
(i) with respect to the health care
practitioner, the entity submits to the
Secretary an application meeting the
requirements of subsection (g)(1)(D); and
(ii) the Secretary, pursuant to subsection
(g)(1)(E), determines that the health care
practitioner is deemed to be an employee of the
Public Health Service.
(C) In the case of a health care practitioner who is
determined by the Secretary pursuant to subsection
(g)(1)(E) to be a health professional volunteer at such
entity, this subsection applies to the health care
practitioner (with respect to services performed on
behalf of the entity sponsoring the health care
practitioner pursuant to subparagraph (B)) for any
cause of action arising from an act or omission of the
health care practitioner occurring on or after the date
on which the Secretary makes such determination.
(D) Subsection (g)(1)(F) applies to a health care
practitioner for purposes of this subsection only to
the extent that, in providing health services to an
individual, each of the conditions specified in
paragraph (2) is met.
(4)(A) Amounts in the fund established under subsection
(k)(2) shall be available for transfer under subparagraph (C)
for purposes of carrying out this subsection.
(B)(i) Not later than May 1 of each fiscal year, the Attorney
General, in consultation with the Secretary, shall submit to
the Congress a report providing an estimate of the amount of
claims (together with related fees and expenses of witnesses)
that, by reason of the acts or omissions of health professional
volunteers, will be paid pursuant to this section during the
calendar year that begins in the following fiscal year.
(ii) Subsection (k)(1)(B) applies to the estimate under
clause (i) regarding health professional volunteers to the same
extent and in the same manner as such subsection applies to the
estimate under such subsection regarding officers, governing
board members, employees, and contractors of entities described
in subsection (g)(4).
(iii) The report shall include a summary of the data relied
upon for the estimate in clause (i), including the number of
claims filed and paid from the previous calendar year.
(C) Not later than December 31 of each fiscal year, the
Secretary shall transfer from the fund under subsection (k)(2)
to the appropriate accounts in the Treasury an amount equal to
the estimate made under subparagraph (B) for the calendar year
beginning in such fiscal year, subject to the extent of amounts
in the fund.
(5)(A) This subsection shall take effect on October 1, 2017,
except as provided in subparagraph (B) and paragraph (6).
(B) Effective on the date of the enactment of this
subsection--
(i) the Secretary may issue regulations for carrying
out this subsection, and the Secretary may accept and
consider applications submitted pursuant to paragraph
(3)(B); and
(ii) reports under paragraph (4)(B) may be submitted
to Congress.
(6) Beginning on [October 1, 2022] October 1, 2027, this
subsection shall cease to have any force or effect.
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 317L-1. SCREENING AND TREATMENT FOR [MATERNAL DEPRESSION]
MATERNAL MENTAL HEALTH AND SUBSTANCE USE DISORDERS.
(a) Grants.--The Secretary shall make grants to States,
Indian Tribes and Tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination and
Education Assistance Act), and Urban Indian organizations (as
such term is defined under the Federally Recognized Indian
Tribe List Act of 1994) to establish, improve, or maintain
programs for screening, assessment, and treatment services,
including culturally and linguistically appropriate services,
as appropriate, [for women who are pregnant, or who have given
birth within the preceding 12 months, for maternal depression]
for women who are postpartum, pregnant, or have given birth
within the preceding 12 months, for maternal mental health and
substance use disorders.
(b) Application.--To seek a grant under this section, [a
State shall submit] an entity listed in subsection (a) shall
submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
require. At a minimum, any such application shall include
explanations of--
(1) how a program, or programs, will increase the
percentage of women screened and treated, as
appropriate, for [maternal depression] maternal mental
health and substance use disorders in 1 or more
communities; and
(2) how a program, or programs, if expanded, would
increase access to screening and treatment services for
[maternal depression] maternal mental health and
substance use disorders.
(c) Priority.--In awarding grants under this section, the
Secretary [may give priority to States proposing to improve or
enhance access to screening] shall give priority to entities
listed in subsection (a) that--
(1) are proposing to create, improve, or enhance
screening, prevention, and treatment services for
[maternal depression] maternal mental health and
substance use disorders in primary care settings[.];
(2) are currently partnered with, or will partner
with, a community-based organization to address
maternal mental health and substance use disorders;
(3) are located in an area with high rates of adverse
maternal health outcomes or significant health,
economic, racial, or ethnic disparities in maternal
health and substance use disorder outcomes; and
(4) operate in a health professional shortage area
designated under section 332.
(d) Use of Funds.--The activities eligible for funding
through a grant under subsection (a)--
(1) shall include--
(A) providing appropriate training [to health
care providers; and] on maternal mental health
and substance use disorder screening, brief
intervention, treatment (as applicable for
health care providers), and referrals for
treatment to health care providers in the
primary care setting and nonclinical perinatal
support workers;
(B) providing information [to health care
providers, including information on maternal
depression screening, treatment, and followup
support services, and linkages to community-
based resources; and] on maternal mental health
and substance use disorder screening, brief
intervention, treatment (as applicable for
health care providers) and referrals for
treatment, follow-up support services, and
linkages to community-based resources to health
care providers in the primary care setting and
clinical perinatal support workers; and
(C) enabling health care providers (such as
obstetrician-gynecologists, nurse
practitioners, nurse midwives, pediatricians,
psychiatrists, mental and other behavioral
health care providers, and adult primary care
clinicians) to provide or receive real-time
psychiatric consultation (in-person or
remotely), including through the use of
technology-enabled collaborative learning and
capacity building models (as defined in section
330N), to aid in the treatment of pregnant and
postpartum women; and
(2) may include--
[(A) enabling health care providers
(including obstetrician-gynecologists,
pediatricians, psychiatrists, mental health
care providers, and adult primary care
clinicians) to provide or receive real-time
psychiatric consultation (in-person or
remotely) to aid in the treatment of pregnant
and parenting women;]
[(B)] (A) establishing linkages with and
among community-based resources, including
mental health resources, primary care
resources, and support groups; [and]
[(C)] (B) utilizing telehealth services,
including for rural areas and medically
underserved areas (as defined in section
330I(a))[.];
(C) providing assistance to pregnant and
postpartum women to receive maternal mental
health and substance use disorder treatment,
including patient consultation, care
coordination, and navigation for such
treatment;
(D) coordinating with maternal and child
health programs of the Federal Government and
State, local, and Tribal governments, including
child psychiatric access programs;
(E) conducting public outreach and awareness
regarding grants under subsection (a);
(F) creating multistate consortia to carry
out the activities required or authorized under
this subsection; and
(G) training health care providers in the
primary care setting and nonclinical perinatal
support workers on trauma-informed care,
culturally and linguistically appropriate
services, and best practices related to
training to improve the provision of maternal
mental health and substance use disorder care
for racial and ethnic minority populations,
including with respect to perceptions and
biases that may affect the approach to, and
provision of, care.
(e) Technical Assistance.--The Secretary shall provide
technical assistance to grantees and entities listed in
subsection (a) for carrying out activities pursuant to this
section.
(f) Dissemination of Best Practices.--The Secretary, based on
evaluation of the activities funded pursuant to this section,
shall identify and disseminate evidence-based or evidence-
informed best practices for screening, assessment, and
treatment services for maternal mental health and substance use
disorders, including culturally and linguistically appropriate
services, for women during pregnancy and 12 months following
pregnancy.
(g) Matching Requirement.--The Federal share of the cost of
the activities for which a grant is made to an entity under
subsection (a) shall not exceed 90 percent of the total cost of
such activities.
[(e)] (h) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated [$5,000,000]
$24,000,000 for each of fiscal years [2018 through 2022] 2023
through 2027.
SEC. 317L-2. TASK FORCE ON MATERNAL MENTAL HEALTH.
(a) Establishment.--Not later than 180 days after the date of
enactment of the Restoring Hope for the Mental Health and Well-
Being Act of 2022, the Secretary, for purposes of identifying,
evaluating, and making recommendations to coordinate and
improve Federal responses to maternal mental health conditions,
shall--
(1) establish a task force to be known as the Task
Force on Maternal Mental Health (in this section
referred to as the ``Task Force''); or
(2) incorporate the duties, public meetings, and
reports specified in subsections (c) through (f) into
existing Federal policy forums, including the Maternal
Health Interagency Policy Committee and the Maternal
Health Working Group, as appropriate.
(b) Membership.--
(1) Composition.--The Task Force shall be composed
of--
(A) the Federal members under paragraph (2);
and
(B) the non-Federal members under paragraph
(3).
(2) Federal members.--The Federal members of the Task
Force shall consist of the following heads of Federal
departments and agencies (or their designees):
(A) The Assistant Secretary for Health of the
Department of Health and Human Services, who
shall serve as Chair.
(B) The Assistant Secretary for Planning and
Evaluation of the Department of Health and
Human Services.
(C) The Assistant Secretary of the
Administration for Children and Families.
(D) The Director of the Centers for Disease
Control and Prevention.
(E) The Administrator of the Centers for
Medicare & Medicaid Services.
(F) The Administrator of the Health Resources
and Services Administration.
(G) The Director of the Indian Health
Service.
(H) The Assistant Secretary for Mental Health
and Substance Use.
(I) Such other Federal departments and
agencies as the Secretary determines
appropriate that serve individuals with
maternal mental health conditions.
(3) Non-federal members.--The non-Federal members of
the Task Force shall--
(A) compose not more than one-half, and not
less than one-third, of the total membership of
the Task Force;
(B) be appointed by the Secretary; and
(C) include--
(i) representatives of medical
societies with expertise in maternal or
mental health;
(ii) representatives of nonprofit
organizations with expertise in
maternal or mental health;
(iii) relevant industry
representatives; and
(iv) other representatives, as
appropriate.
(4) Deadline for designating designees.--If the
Assistant Secretary for Health, or the head of a
Federal department or agency serving as a member of the
Task Force under paragraph (2), chooses to be
represented on the Task Force by a designee, the
Assistant Secretary or department or agency head shall
designate such designee not later than 90 days after
the date of the enactment of this section.
(c) Duties.--The Task Force shall--
(1) prepare and regularly update a report that
analyzes and evaluates the state of national maternal
mental health policy and programs at the Federal,
State, and local levels, and identifies best practices
with respect to maternal mental health policy,
including--
(A) a set of evidence-based, evidence-
informed, and promising practices with respect
to--
(i) prevention strategies for
individuals at risk of experiencing a
maternal mental health condition,
including strategies and
recommendations to address health
inequities;
(ii) the identification, screening,
diagnosis, intervention, and treatment
of individuals and families affected by
a maternal mental health condition;
(iii) the expeditious referral to,
and implementation of, practices and
supports that prevent and mitigate the
effects of a maternal mental health
condition, including strategies and
recommendations to eliminate the racial
and ethnic disparities that exist in
maternal mental health; and
(iv) community-based or
multigenerational practices that
support individuals and families
affected by a maternal mental health
condition; and
(B) Federal and State programs and activities
to prevent, screen, diagnose, intervene, and
treat maternal mental health conditions;
(2) develop and regularly update a national strategy
for maternal mental health, taking into consideration
the findings of the report under paragraph (1), on how
the Task Force and Federal departments and agencies
represented on the Task Force may prioritize options
for, and may implement a coordinated approach to,
addressing maternal mental health conditions, including
by--
(A) increasing prevention, screening,
diagnosis, intervention, treatment, and access
to care, including clinical and nonclinical
care such as peer-support and community health
workers, through the public and private
sectors;
(B) providing support for pregnant or
postpartum individuals who are at risk for or
experiencing a maternal mental health
condition, and their families, as appropriate;
(C) reducing racial, ethnic, geographic, and
other health disparities for prevention,
diagnosis, intervention, treatment, and access
to care;
(D) identifying options for modifying,
strengthening, and coordinating Federal
programs and activities, such as the Medicaid
program under title XIX of the Social Security
Act and the State Children's Health Insurance
Program under title XXI of such Act, including
existing infant and maternity programs, in
order to increase research, prevention,
identification, intervention, and treatment
with respect to maternal mental health; and
(E) planning, data sharing, and communication
within and across Federal departments,
agencies, offices, and programs;
(3) solicit public comments from stakeholders for the
report under paragraph (1) and the national strategy
under paragraph (2), including comments from frontline
service providers, mental health professionals,
researchers, experts in maternal mental health,
institutions of higher education, public health
agencies (including maternal and child health
programs), and industry representatives, in order to
inform the activities and reports of the Task Force;
and
(4) disaggregate any data collected under this
section by race, ethnicity, geographical location, age,
marital status, socioeconomic level, and other factors,
as the Secretary determines appropriate.
(d) Meetings.--The Task Force shall--
(1) meet not less than two times each year; and
(2) convene public meetings, as appropriate, to
fulfill its duties under this section.
(e) Reports to Public and Federal Leaders.--The Task Force
shall make publicly available and submit to the heads of
relevant Federal departments and agencies, the Committee on
Energy and Commerce of the House of Representatives, the
Committee on Health, Education, Labor, and Pensions of the
Senate, and other relevant congressional committees, the
following:
(1) Not later than 1 year after the first meeting of
the Task Force, an initial report under subsection
(c)(1).
(2) Not later than 2 years after the first meeting of
the Task Force, an initial national strategy under
subsection (c)(2).
(3) Each year thereafter--
(A) an updated report under subsection
(c)(1);
(B) an updated national strategy under
subsection (c)(2); or
(C) if no update is made under subsection
(c)(1) or (c)(2), a report summarizing the
activities of the Task Force.
(f) Reports to Governors.--Upon finalizing the initial
national strategy under subsection (c)(2), and upon making
relevant updates to such strategy, the Task Force shall submit
a report to the Governors of all States describing
opportunities for local- and State-level partnerships
identified under subsection (c)(2)(D).
(g) Sunset.--The Task Force shall terminate on September 30,
2027.
(h) Nonduplication of Federal Efforts.--The Secretary may
relieve the Task Force, in carrying out subsections (c) through
(f), from responsibility for carrying out such activities as
may be specified by the Secretary as duplicative with other
activities carried out by the Department of Health and Human
Services.
* * * * * * *
Part D--Primary Health Care
Subpart I--Health Centers
* * * * * * *
SEC. 330M. PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration and in coordination with other relevant Federal
agencies, shall award grants to States, political subdivisions
of States, and [Indian tribes and tribal organizations] Indian
Tribes and Tribal organizations (for purposes of this section,
as such terms are defined in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b))
or, in the case of a State that does not submit an application,
a nonprofit entity that has the support of the State to promote
behavioral health integration in pediatric primary care by--
(1) supporting the development of statewide or
regional pediatric mental health care telehealth access
programs; and
(2) supporting the improvement of existing statewide
or regional pediatric mental health care telehealth
access programs.
(b) Program Requirements.--
(1) In general.--A pediatric mental health care
telehealth access program referred to in subsection
(a), with respect to which a grant under such
subsection may be used, shall--
(A) be a statewide or regional network of
pediatric mental health teams that provide
support to pediatric primary care sites as an
integrated team;
(B) support and further develop organized
State or regional networks of pediatric mental
health teams to provide consultative support to
pediatric primary care sites;
(C) conduct an assessment of critical
behavioral consultation needs among pediatric
providers and such providers' preferred
mechanisms for receiving consultation,
training, and technical assistance;
(D) develop an online database and
communication mechanisms, including telehealth,
to facilitate consultation support to pediatric
practices;
(E) provide rapid statewide or regional
clinical telephone or telehealth consultations
when requested between the pediatric mental
health teams and pediatric primary care
providers;
(F) conduct training and provide technical
assistance to pediatric primary care providers
to support the early identification, diagnosis,
treatment, and referral of children with
behavioral health conditions;
(G) provide information to pediatric
providers about, and assist pediatric providers
in accessing, pediatric mental health care
providers, including child and adolescent
psychiatrists, developmental-behavioral
pediatricians, and licensed mental health
professionals, such as psychologists, social
workers, or mental health counselors and in
scheduling and conducting technical assistance;
(H) assist with referrals to specialty care
and community or behavioral health resources[;
and];
(I) maintain an up-to-date list of community-
based supports for children with mental health
problems; and
[(I)] (J) establish mechanisms for measuring
and monitoring increased access to pediatric
mental health care services by pediatric
primary care providers and expanded capacity of
pediatric primary care providers to identify,
treat, and refer children with mental health
problems.
(2) Support to schools and emergency departments.--In
addition to the activities required by paragraph (1), a
pediatric mental health care telehealth access program
referred to in subsection (a), with respect to which a
grant under such subsection may be used, may provide
support to schools and emergency departments.
(3) Priority.--In awarding grants under this section,
the Secretary shall give priority to applicants
proposing to--
(A) continue existing programs that meet the
requirements of paragraph (1);
(B) establish a pediatric mental health care
telehealth access program in the jurisdiction
of a State, Territory, Indian Tribe, or Tribal
organization that does not yet have such a
program; or
(C) expand a pediatric mental health care
telehealth access program to include one or
more new sites of care, such as a school or
emergency department.
[(2)] (4) Pediatric mental health teams.--In this
subsection, the term ``pediatric mental health team''
means a team consisting of at least one case
coordinator, at least one child and adolescent
psychiatrist, and at least one licensed clinical mental
health professional, such as a psychologist, social
worker, or mental health counselor. Such a team may
include a developmental-behavioral pediatrician. Such a
team may be regionally based.
(c) Application.--A State, political subdivision of a State,
[Indian tribe, or tribal organization] Indian Tribe, Tribal
organization, or nonprofit entity seeking a grant under this
section shall submit an application to the Secretary at such
time, in such manner, and containing such information as the
Secretary may require, including a plan for the comprehensive
evaluation of activities that are carried out with funds
received under such grant.
(d) Evaluation.--A State, political subdivision of a State,
[Indian tribe, or tribal organization] Indian Tribe, Tribal
organization, or nonprofit entity that receives a grant under
this section shall prepare and submit an evaluation of
activities that are carried out with funds received under such
grant to the Secretary at such time, in such manner, and
containing such information as the Secretary may reasonably
require, including a process and outcome evaluation.
(e) Access to Broadband.--In administering grants under this
section, the Secretary may coordinate with other agencies to
ensure that funding opportunities are available to support
access to reliable, high-speed Internet for providers.
(f) Matching Requirement.--The Secretary may not award a
grant under this section unless the State, political
subdivision of a State, [Indian tribe, or tribal organization]
Indian Tribe, Tribal organization, or nonprofit entity involved
agrees, with respect to the costs to be incurred by the State,
political subdivision of a State, [Indian tribe, or tribal
organization] Indian Tribe, Tribal organization, or nonprofit
entity in carrying out the purpose described in this section,
to make available non-Federal contributions (in cash or in
kind) toward such costs in an amount that is not less than 20
percent of Federal funds provided in the grant.
[(g) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated, $9,000,000
for the period of fiscal years 2018 through 2022.]
(g) Technical Assistance.--The Secretary shall award grants
or contracts to one or more eligible entities (as defined by
the Secretary) for the purposes of providing technical
assistance and evaluation support to grantees under subsection
(a).
(h) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated--
(1) $14,000,000 for each of fiscal years 2023 through
2025; and
(2) $30,000,000 for each of fiscal years 2026 through
2027.
* * * * * * *
PART P--ADDITIONAL PROGRAMS
* * * * * * *
SEC. 399V-7. MATERNAL MENTAL HEALTH HOTLINE.
(a) In General.--The Secretary shall maintain, directly or by
grant or contract, a national hotline to provide emotional
support, information, brief intervention, and mental health and
substance use disorder resources to pregnant and postpartum
women at risk of, or affected by, maternal mental health and
substance use disorders, and to their families or household
members.
(b) Requirements for Hotline.--The hotline under subsection
(a) shall--
(1) be a 24/7 real-time hotline;
(2) provide voice and text support;
(3) be staffed by certified peer specialists,
licensed health care professionals, or licensed mental
health professionals who are trained on--
(A) maternal mental health and substance use
disorder prevention, identification, and
intervention; and
(B) providing culturally and linguistically
appropriate support; and
(4) provide maternal mental health and substance use
disorder assistance and referral services to meet the
needs of underserved populations, individuals with
disabilities, and family and household members of
pregnant or postpartum women at risk of experiencing
maternal mental health and substance use disorders.
(c) Additional Requirements.--In maintaining the hotline
under subsection (a), the Secretary shall--
(1) consult with the Domestic Violence Hotline,
National Suicide Prevention Lifeline, and Veterans
Crisis Line to ensure that pregnant and postpartum
women are connected in real-time to the appropriate
specialized hotline service, when applicable;
(2) conduct a public awareness campaign for the
hotline; and
(3) consult with Federal departments and agencies,
including the Centers of Excellence of the Substance
Abuse and Mental Health Services Administration and the
Department of Veterans Affairs, to increase awareness
regarding the hotline.
(d) Annual Report.--The Secretary shall submit an annual
report to the Congress on the hotline under subsection (a) and
implementation of this section, including--
(1) an evaluation of the effectiveness of activities
conducted or supported under subsection (a);
(2) a directory of entities or organizations to which
staff maintaining the hotline funded under this section
may make referrals; and
(3) such additional information as the Secretary
determines appropriate.
(e) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $10,000,000
for each of fiscal years 2023 through 2027.
PART Q--PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
* * * * * * *
SEC. 399Z-2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION,
INTERVENTION, AND TREATMENT.
(a) Grants.--The Secretary shall--
(1) award grants to eligible entities to develop,
maintain, or enhance infant and early childhood mental
health promotion, intervention, and treatment programs,
including--
(A) programs for infants and children at
significant risk of developing, showing early
signs of, or having been diagnosed with mental
illness, including a serious emotional
disturbance; and
(B) multigenerational therapy and other
services that support the caregiving
relationship; and
(2) ensure that programs funded through grants under
this section are evidence-informed or evidence-based
models, practices, and methods that are, as
appropriate, culturally and linguistically appropriate,
and can be replicated in other appropriate settings.
(b) Eligible Children and Entities.--In this section:
(1) Eligible child.--The term ``eligible child''
means a child from birth to not more than 12 years of
age who--
(A) is at risk for, shows early signs of, or
has been diagnosed with a mental illness,
including a serious emotional disturbance; and
(B) may benefit from infant and early
childhood intervention or treatment programs or
specialized preschool or elementary school
programs that are evidence-based or that have
been scientifically demonstrated to show
promise but would benefit from further applied
development.
(2) Eligible entity.--The term ``eligible entity''
means a human services agency or nonprofit institution
that--
(A) employs licensed mental health
professionals who have specialized training and
experience in infant and early childhood mental
health assessment, diagnosis, and treatment, or
is accredited or approved by the appropriate
State agency, as applicable, to provide for
children from infancy to 12 years of age mental
health promotion, intervention, or treatment
services; and
(B) provides services or programs described
in subsection (a) that are evidence-based or
that have been scientifically demonstrated to
show promise but would benefit from further
applied development.
(c) Application.--An eligible entity seeking a grant under
subsection (a) shall submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
(d) Use of Funds for Early Intervention and Treatment
Programs.--An eligible entity may use amounts awarded under a
grant under subsection (a)(1) to carry out the following:
(1) Provide age-appropriate mental health promotion
and early intervention services or mental illness
treatment services, which may include specialized
programs, for eligible children at significant risk of
developing, showing early signs of, or having been
diagnosed with a mental illness, including a serious
emotional disturbance. Such services may include social
and behavioral services as well as multigenerational
therapy and other services that support the caregiving
relationship.
(2) Provide training for health care professionals
with expertise in infant and early childhood mental
health care with respect to appropriate and relevant
integration with other disciplines such as primary care
clinicians, early intervention specialists, child
welfare staff, home visitors, early care and education
providers, and others who work with young children and
families.
(3) Provide mental health consultation to personnel
of early care and education programs (including
licensed or regulated center-based and home-based child
care, home visiting, preschool special education, and
early intervention programs) who work with children and
families.
(4) Provide training for mental health clinicians in
infant and early childhood in promising and evidence-
based practices and models for infant and early
childhood mental health treatment and early
intervention, including with regard to practices for
identifying and treating mental illness and behavioral
disorders of infants and children resulting from
exposure or repeated exposure to adverse childhood
experiences or childhood trauma.
(5) Provide age-appropriate assessment, diagnostic,
and intervention services for eligible children,
including early mental health promotion, intervention,
and treatment services.
(e) Matching Funds.--The Secretary may not award a grant
under this section to an eligible entity unless the eligible
entity agrees, with respect to the costs to be incurred by the
eligible entity in carrying out the activities described in
subsection (d), to make available non-Federal contributions (in
cash or in kind) toward such costs in an amount that is not
less than 10 percent of the total amount of Federal funds
provided in the grant.
(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated [$20,000,000
for the period of fiscal years 2018 through 2022] $50,000,000
for the period of fiscal years 2023 through 2027.
* * * * * * *
TITLE V--SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
Part A--Organization and General Authorities
SEC. 501. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
(a) Establishment.--The Substance Abuse and Mental Health
Services Administration (hereafter referred to in this title as
the ``Administration'') is an agency of the Service.
(b) Centers.--The following Centers are agencies of the
Administration:
(1) The Center for Substance Abuse Treatment.
(2) The Center for Substance Abuse Prevention.
(3) The Center for Mental Health Services.
(c) Assistant Secretary and Deputy Assistant Secretary.--
(1) Assistant secretary.--The Administration shall be
headed by an official to be known as the Assistant
Secretary for Mental Health and Substance Use
(hereinafter in this title referred to as the
``Assistant Secretary'') who shall be appointed by the
President, by and with the advice and consent of the
Senate.
(2) Deputy assistant secretary.--The Assistant
Secretary, with the approval of the Secretary, may
appoint a Deputy Assistant Secretary and may employ and
prescribe the functions of such officers and employees,
including attorneys, as are necessary to administer the
activities to be carried out through the
Administration.
(d) Authorities.--The Secretary, acting through the Assistant
Secretary, shall--
(1) supervise the functions of the Centers of the
Administration in order to assure that the programs
carried out through each such Center receive
appropriate and equitable support and that there is
cooperation among the Centers in the implementation of
such programs;
(2) establish and implement, through the respective
Centers, a comprehensive program to improve the
provision of treatment and related services to
individuals with respect to substance use disorders and
mental illness and to improve prevention services,
promote mental health and protect the legal rights of
individuals with mental illnesses and individuals with
substance use disorders;
(3) carry out the administrative and financial
management, policy development and planning,
evaluation, knowledge dissemination, and public
information functions that are required for the
implementation of this title;
(4) assure that the Administration conduct and
coordinate demonstration projects, evaluations, and
service system assessments and other activities
necessary to improve the availability and quality of
treatment, prevention and related services;
(5) support activities that will improve the
provision of treatment, prevention and related
services, including the development of national mental
health and substance use disorder goals and model
programs;
(6) in cooperation with the National Institutes of
Health, the Centers for Disease Control and Prevention,
and the Health Resources and Services Administration,
develop educational materials and intervention
strategies to reduce the risks of HIV, hepatitis,
tuberculosis, and other communicable diseases among
individuals with mental or substance use disorders, and
to develop appropriate mental health services for
individuals with such diseases or disorders;
(7) coordinate Federal policy with respect to the
provision of treatment services for substance use
disorders, including services that utilize drugs or
devices approved or cleared by the Food and Drug
Administration for the treatment of substance use
disorders;
(8) conduct programs, and assure the coordination of
such programs with activities of the National
Institutes of Health and the Agency for Healthcare
Research and Quality, as appropriate, to evaluate the
process, outcomes and community impact of prevention
and treatment services and systems of care in order to
identify the manner in which such services can most
effectively be provided;
(9) collaborate with the Director of the National
Institutes of Health in the development and maintenance
of a system by which the relevant research findings of
the National Institute on Drug Abuse, the National
Institute on Alcohol Abuse and Alcoholism, the National
Institute of Mental Health, and, as appropriate, the
Agency for Healthcare Research and Quality are
disseminated to service providers in a manner designed
to improve the delivery and effectiveness of
prevention, treatment, and recovery support services
and are appropriately incorporated into programs
carried out by the Administration;
(10) encourage public and private entities that
provide health insurance to provide benefits for
substance use disorder and mental health services;
(11) work with relevant agencies of the Department of
Health and Human Services on integrating mental health
promotion and substance use disorder prevention with
general health promotion and disease prevention and
integrating mental and substance use disorders
treatment services with physical health treatment
services;
(12) monitor compliance by hospitals and other
facilities with the requirements of sections 542 and
543;
(13) with respect to grant programs authorized under
this title or part B of title XIX, or grant programs
otherwise funded by the Administration--
(A) require that all grants that are awarded
for the provision of services are subject to
performance and outcome evaluations;
(B) ensure that the director of each Center
of the Administration consistently documents
the application of criteria when awarding
grants and the ongoing oversight of grantees
after such grants are awarded;
(C) require that all grants that are awarded
to entities other than States are awarded only
after the State in which the entity intends to
provide services--
(i) is notified of the pendency of
the grant application; and
(ii) is afforded an opportunity to
comment on the merits of the
application; and
(D) inform a State when any funds are awarded
through such a grant to any entity within such
State;
(14) assure that services provided with amounts
appropriated under this title are provided bilingually,
if appropriate;
(15) improve coordination among prevention programs,
treatment facilities and nonhealth care systems such as
employers, labor unions, and schools, and encourage the
adoption of employee assistance programs and student
assistance programs;
(16) maintain a clearinghouse for substance use
disorder information, including evidence-based and
promising best practices for prevention, treatment, and
recovery support services for individuals with mental
and substance use disorders, to assure the widespread
dissemination of such information to States, political
subdivisions, educational agencies and institutions,
treatment providers, and the general public;
(17) in collaboration with the National Institute on
Aging, and in consultation with the National Institute
on Drug Abuse, the National Institute on Alcohol Abuse
and Alcoholism and the National Institute of Mental
Health, as appropriate, promote and evaluate substance
use disorder services for older Americans in need of
such services, and mental health services for older
Americans who are seriously mentally ill;
(18) promote the coordination of service programs
conducted by other departments, agencies, organizations
and individuals that are or may be related to the
problems of individuals suffering from mental illness
or substance abuse, including liaisons with the Social
Security Administration, Centers for Medicare &
Medicaid Services, and other programs of the
Department, as well as liaisons with the Department of
Education, Department of Justice, and other Federal
Departments and offices, as appropriate;
(19) consult with State, local, and tribal
governments, nongovernmental entities, and individuals
with mental illness, particularly adults with a serious
mental illness, children with a serious emotional
disturbance, and the family members of such adults and
children, with respect to improving community-based and
other mental health services;
(20) collaborate with the Secretary of Defense and
the Secretary of Veterans Affairs to improve the
provision of mental and substance use disorder services
provided by the Department of Defense and the
Department of Veterans Affairs to members of the Armed
Forces, veterans, and the family members of such
members and veterans, including through the provision
of services using the telehealth capabilities of the
Department of Defense and the Department of Veterans
Affairs;
(21) collaborate with the heads of relevant Federal
agencies and departments, States, communities, and
nongovernmental experts to improve mental and substance
use disorders services for chronically homeless
individuals, including by designing strategies to
provide such services in supportive housing;
(22) work with States and other stakeholders to
develop and support activities to recruit and retain a
workforce addressing mental and substance use
disorders;
(23) collaborate with the Attorney General and
representatives of the criminal justice system to
improve mental and substance use disorders services for
individuals who have been arrested or incarcerated;
(24) after providing an opportunity for public input,
set standards for grant programs under this title for
mental and substance use disorders services and
prevention programs, which standards may address--
(A) the capacity of the grantee to implement
the award;
(B) requirements for the description of the
program implementation approach;
(C) the extent to which the grant plan
submitted by the grantee as part of its
application must explain how the grantee will
reach the population of focus and provide a
statement of need, which may include
information on how the grantee will increase
access to services and a description of
measurable objectives for improving outcomes;
(D) the extent to which the grantee must
collect and report on required performance
measures; and
(E) the extent to which the grantee is
proposing to use evidence-based practices;
[and]
(25) advance, through existing programs, the use of
performance metrics, including those based on the
recommendations on performance metrics from the
Assistant Secretary for Planning and Evaluation under
section 6021(d) of the Helping Families in Mental
Health Crisis Reform Act of 2016[.]; and
(26) collaborate with national accrediting entities,
reputable providers, organizations or individuals with
established expertise in delivery of recovery housing
services, States, Federal agencies (including the
Department of Health and Human Services, the Department
of Housing and Urban Development, and the agencies
listed in section 550(e)(2)(B)), and other relevant
stakeholders, to promote the availability of high-
quality recovery housing and services for individuals
with a substance use disorder.
(e) Associate Administrator for Alcohol Prevention and
Treatment Policy.--
(1) In general.--There may be in the Administration
an Associate Administrator for Alcohol Prevention and
Treatment Policy to whom the Assistant Secretary may
delegate the functions of promoting, monitoring, and
evaluating service programs for the prevention and
treatment of alcoholism and alcohol abuse within the
Center for Substance Abuse Prevention, the Center for
Substance Abuse Treatment and the Center for Mental
Health Services, and coordinating such programs among
the Centers, and among the Centers and other public and
private entities. The Associate Administrator also may
ensure that alcohol prevention, education, and policy
strategies are integrated into all programs of the
Centers that address substance abuse prevention,
education, and policy, and that the Center for
Substance Abuse Prevention addresses the Healthy People
2010 goals and the National Dietary Guidelines of the
Department of Health and Human Services and the
Department of Agriculture related to alcohol
consumption.
(2) Plan.--
(A) The Assistant Secretary, acting through
the Associate Administrator for Alcohol
Prevention and Treatment Policy, shall develop,
and periodically review and as appropriate
revise, a plan for programs and policies to
treat and prevent alcoholism and alcohol abuse.
The plan shall be developed (and reviewed and
revised) in collaboration with the Directors of
the Centers of the Administration and in
consultation with members of other Federal
agencies and public and private entities.
(B) Not later than 1 year after the date of
the enactment of the ADAMHA Reorganization Act,
the Assistant Secretary shall submit to the
Congress the first plan developed under
subparagraph (A).
(3) Report.--
(A) Not less than once during each 2 years,
the Assistant Secretary, acting through the
Associate Administrator for Alcohol Prevention
and Treatment Policy, shall prepare a report
describing the alcoholism and alcohol abuse
prevention and treatment programs undertaken by
the Administration and its agencies, and the
report shall include a detailed statement of
the expenditures made for the activities
reported on and the personnel used in
connection with such activities.
(B) Each report under subparagraph (A) shall
include a description of any revisions in the
plan under paragraph (2) made during the
preceding 2 years.
(C) Each report under subparagraph (A) shall
be submitted to the Assistant Secretary for
inclusion in the biennial report under
subsection (m).
(f) Associate Administrator for Women's Services.--
(1) Appointment.--The Assistant Secretary, with the
approval of the Secretary, shall appoint an Associate
Administrator for Women's Services who shall report
directly to the Assistant Secretary.
(2) Duties.--The Associate Administrator appointed
under paragraph (1) shall--
(A) establish a committee to be known as the
Coordinating Committee for Women's Services
(hereafter in this subparagraph referred to as
the ``Coordinating Committee''), which shall be
composed of the Directors of the agencies of
the Administration (or the designees of the
Directors);
(B) acting through the Coordinating
Committee, with respect to women's substance
abuse and mental health services--
(i) identify the need for such
services, and make an estimate each
fiscal year of the funds needed to
adequately support the services;
(ii) identify needs regarding the
coordination of services;
(iii) encourage the agencies of the
Administration to support such
services; and
(iv) assure that the unique needs of
minority women, including Native
American, Hispanic, African-American
and Asian women, are recognized and
addressed within the activities of the
Administration; and
(C) establish an advisory committee to be
known as the Advisory Committee for Women's
Services, which shall be composed of not more
than 10 individuals, a majority of whom shall
be women, who are not officers or employees of
the Federal Government, to be appointed by the
Assistant Secretary from among physicians,
practitioners, treatment providers, and other
health professionals, whose clinical practice,
specialization, or professional expertise
includes a significant focus on women's
substance abuse and mental health conditions,
that shall--
(i) advise the Associate
Administrator on appropriate activities
to be undertaken by the agencies of the
Administration with respect to women's
substance abuse and mental health
services, including services which
require a multidisciplinary approach;
(ii) collect and review data,
including information provided by the
Secretary (including the material
referred to in paragraph (3)), and
report biannually to the Assistant
Secretary regarding the extent to which
women are represented among senior
personnel, and make recommendations
regarding improvement in the
participation of women in the workforce
of the Administration; and
(iii) prepare, for inclusion in the
biennial report required pursuant to
subsection (m), a description of
activities of the Committee, including
findings made by the Committee
regarding--
(I) the extent of
expenditures made for women's
substance abuse and mental
health services by the agencies
of the Administration; and
(II) the estimated level of
funding needed for substance
abuse and mental health
services to meet the needs of
women;
(D) improve the collection of data on women's
health by--
(i) reviewing the current data at the
Administration to determine its
uniformity and applicability;
(ii) developing standards for all
programs funded by the Administration
so that data are, to the extent
practicable, collected and reported
using common reporting formats,
linkages and definitions; and
(iii) reporting to the Assistant
Secretary a plan for incorporating the
standards developed under clause (ii)
in all Administration programs and a
plan to assure that the data so
collected are accessible to health
professionals, providers, researchers,
and members of the public; and
(E) shall establish, maintain, and operate a
program to provide information on women's
substance abuse and mental health services.
(3) Study.--
(A) The Secretary, acting through the
Assistant Secretary for Personnel, shall
conduct a study to evaluate the extent to which
women are represented among senior personnel at
the Administration.
(B) Not later than 90 days after the date of
the enactment of the ADAMHA Reorganization Act,
the Assistant Secretary for Personnel shall
provide the Advisory Committee for Women's
Services with a study plan, including the
methodology of the study and any sampling
frames. Not later than 180 days after such date
of enactment, the Assistant Secretary shall
prepare and submit directly to the Advisory
Committee a report concerning the results of
the study conducted under subparagraph (A).
(C) The Secretary shall prepare and provide
to the Advisory Committee for Women's Services
any additional data as requested.
(4) Office.--Nothing in this subsection shall be
construed to preclude the Secretary from establishing
within the Substance Abuse and Mental Health
Administration an Office of Women's Health.
(5) Definition.--For purposes of this subsection, the
term ``women's substance abuse and mental health
conditions'', with respect to women of all age, ethnic,
and racial groups, means all aspects of substance abuse
and mental illness--
(A) unique to or more prevalent among women;
or
(B) with respect to which there have been
insufficient services involving women or
insufficient data.
(g) Chief Medical Officer.--
(1) In general.--The Assistant Secretary, with the
approval of the Secretary, shall appoint a Chief
Medical Officer to serve within the Administration.
(2) Eligible candidates.--The Assistant Secretary
shall select the Chief Medical Officer from among
individuals who--
(A) have a doctoral degree in medicine or
osteopathic medicine;
(B) have experience in the provision of
mental or substance use disorder services;
(C) have experience working with mental or
substance use disorder programs;
(D) have an understanding of biological,
psychosocial, and pharmaceutical treatments of
mental or substance use disorders; and
(E) are licensed to practice medicine in one
or more States.
(3) Duties.--The Chief Medical Officer shall--
(A) serve as a liaison between the
Administration and providers of mental and
substance use disorders prevention, treatment,
and recovery services;
(B) assist the Assistant Secretary in the
evaluation, organization, integration, and
coordination of programs operated by the
Administration;
(C) promote evidence-based and promising best
practices, including culturally and
linguistically appropriate practices, as
appropriate, for the prevention and treatment
of, and recovery from, mental and substance use
disorders, including serious mental illness and
serious emotional disturbances;
(D) participate in regular strategic planning
with the Administration;
(E) coordinate with the Assistant Secretary
for Planning and Evaluation to assess the use
of performance metrics to evaluate activities
within the Administration related to mental and
substance use disorders; and
(F) coordinate with the Assistant Secretary
to ensure mental and substance use disorders
grant programs within the Administration
consistently utilize appropriate performance
metrics and evaluation designs.
(h) Services of Experts.--
(1) In general.--The Assistant Secretary may obtain
(in accordance with section 3109 of title 5, United
States Code, but without regard to the limitation in
such section on the number of days or the period of
service) the services of not more than 20 experts or
consultants who have professional qualifications. Such
experts and consultants shall be obtained for the
Administration and for each of its agencies.
(2) Compensation and expenses.--
(A) Experts and consultants whose services
are obtained under paragraph (1) shall be paid
or reimbursed for their expenses associated
with traveling to and from their assignment
location in accordance with sections 5724,
5724a(a), 5724a(c), and 5726(c) of title 5,
United States Code.
(B) Expenses specified in subparagraph (A)
may not be allowed in connection with the
assignment of an expert or consultant whose
services are obtained under paragraph (1),
unless and until the expert or consultant
agrees in writing to complete the entire period
of assignment or one year, whichever is
shorter, unless separated or reassigned for
reasons beyond the control of the expert or
consultant that are acceptable to the
Secretary. If the expert or consultant violates
the agreement, the money spent by the United
States for the expenses specified in
subparagraph (A) is recoverable from the expert
or consultant as a debt of the United States.
The Secretary may waive in whole or in part a
right of recovery under this subparagraph.
(i) Peer Review Groups.--The Assistant Secretary shall,
without regard to the provisions of title 5, United States
Code, governing appointments in the competitive service, and
without regard to the provisions of chapter 51 and subchapter
III of chapter 53 of such title, relating to classification and
General Schedule pay rates, establish such peer review groups
and program advisory committees as are needed to carry out the
requirements of this title and appoint and pay members of such
groups, except that officers and employees of the United States
shall not receive additional compensation for services as
members of such groups. The Federal Advisory Committee Act
shall not apply to the duration of a peer review group
appointed under this subsection.
(j) Voluntary Services.--The Assistant Secretary may accept
voluntary and uncompensated services.
(k) Administration.--The Assistant Secretary shall ensure
that programs and activities assigned under this title to the
Administration are fully administered by the respective Centers
to which such programs and activities are assigned.
(l) Strategic Plan.--
(1) In general.--Not later than September 30, 2018,
and every 4 years thereafter, the Assistant Secretary
shall develop and carry out a strategic plan in
accordance with this subsection for the planning and
operation of activities carried out by the
Administration, including evidence-based programs.
(2) Coordination.--In developing and carrying out the
strategic plan under this subsection, the Assistant
Secretary shall take into consideration the findings
and recommendations of the Assistant Secretary for
Planning and Evaluation under section 6021(d) of the
Helping Families in Mental Health Crisis Reform Act of
2016 and the report of the Interdepartmental Serious
Mental Illness Coordinating Committee under [section
6031 of such Act] section 501B of this Act.
(3) Publication of plan.--Not later than September
30, 2018, and every 4 years thereafter, the Assistant
Secretary shall--
(A) submit the strategic plan developed under
paragraph (1) to the Committee on Energy and
Commerce and the Committee on Appropriations of
the House of Representatives and the Committee
on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate;
and
(B) post such plan on the Internet website of
the Administration.
(4) Contents.--The strategic plan developed under
paragraph (1) shall--
(A) identify strategic priorities, goals, and
measurable objectives for mental and substance
use disorders activities and programs operated
and supported by the Administration, including
priorities to prevent or eliminate the burden
of mental and substance use disorders;
(B) identify ways to improve the quality of
services for individuals with mental and
substance use disorders, and to reduce
homelessness, arrest, incarceration, violence,
including self-directed violence, and
unnecessary hospitalization of individuals with
a mental or substance use disorder, including
adults with a serious mental illness or
children with a serious emotional disturbance;
(C) ensure that programs provide, as
appropriate, access to effective and evidence-
based prevention, diagnosis, intervention,
treatment, and recovery services, including
culturally and linguistically appropriate
services, as appropriate, for individuals with
a mental or substance use disorder;
(D) identify opportunities to collaborate
with the Health Resources and Services
Administration to develop or improve--
(i) initiatives to encourage
individuals to pursue careers
(especially in rural and underserved
areas and with rural and underserved
populations) as psychiatrists,
including child and adolescent
psychiatrists, psychologists,
psychiatric nurse practitioners,
physician assistants, clinical social
workers, certified peer support
specialists, licensed professional
counselors, or other licensed or
certified mental health or substance
use disorder professionals, including
such professionals specializing in the
diagnosis, evaluation, or treatment of
adults with a serious mental illness or
children with a serious emotional
disturbance; and
(ii) a strategy to improve the
recruitment, training, and retention of
a workforce for the treatment of
individuals with mental or substance
use disorders, or co-occurring
disorders;
(E) identify opportunities to improve
collaboration with States, local governments,
communities, and Indian tribes and tribal
organizations (as such terms are defined in
section 4 of the Indian Self-Determination and
Education Assistance Act); and
(F) specify a strategy to disseminate
evidence-based and promising best practices
related to prevention, diagnosis, early
intervention, treatment, and recovery services
related to mental illness, particularly for
adults with a serious mental illness and
children with a serious emotional disturbance,
and for individuals with a substance use
disorder.
(m) Biennial Report Concerning Activities and Progress.--Not
later than September 30, 2020, and every 2 years thereafter,
the Assistant Secretary shall prepare and submit to the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate, and post on the
Internet website of the Administration, a report containing at
a minimum--
(1) a review of activities conducted or supported by
the Administration, including progress toward strategic
priorities, goals, and objectives identified in the
strategic plan developed under subsection (l);
(2) an assessment of programs and activities carried
out by the Assistant Secretary, including the extent to
which programs and activities under this title and part
B of title XIX meet identified goals and performance
measures developed for the respective programs and
activities;
(3) a description of the progress made in addressing
gaps in mental and substance use disorders prevention,
treatment, and recovery services and improving outcomes
by the Administration, including with respect to
serious mental illnesses, serious emotional
disturbances, and co-occurring disorders;
(4) a description of the manner in which the
Administration coordinates and partners with other
Federal agencies and departments related to mental and
substance use disorders, including activities related
to--
(A) the implementation and dissemination of
research findings into improved programs,
including with respect to how advances in
serious mental illness and serious emotional
disturbance research have been incorporated
into programs;
(B) the recruitment, training, and retention
of a mental and substance use disorders
workforce;
(C) the integration of mental disorder
services, substance use disorder services, and
physical health services;
(D) homelessness; and
(E) veterans;
(5) a description of the manner in which the
Administration promotes coordination by grantees under
this title, and part B of title XIX, with State or
local agencies; and
(6) a description of the activities carried out under
section 501A(e), with respect to mental and substance
use disorders, including--
(A) the number and a description of grants
awarded;
(B) the total amount of funding for grants
awarded;
(C) a description of the activities supported
through such grants, including outcomes of
programs supported; and
(D) information on how the National Mental
Health and Substance Use Policy Laboratory is
consulting with the Assistant Secretary for
Planning and Evaluation and collaborating with
the Center for Substance Abuse Treatment, the
Center for Substance Abuse Prevention, the
Center for Behavioral Health Statistics and
Quality, and the Center for Mental Health
Services to carry out such activities; and
(7) recommendations made by the Assistant Secretary
for Planning and Evaluation under section 6021 of the
Helping Families in Mental Health Crisis Reform Act of
2016 to improve programs within the Administration, and
actions taken in response to such recommendations to
improve programs within the Administration.
The Assistant Secretary may meet reporting requirements
established under this title by providing the contents of such
reports as an addendum to the biennial report established under
this subsection, notwithstanding the timeline of other
reporting requirements in this title. Nothing in this
subsection shall be construed to alter the content requirements
of such reports or authorize the Assistant Secretary to alter
the timeline of any such reports to be less frequent than
biennially, unless as specified in this title.
(n) Applications for Grants and Contracts.--With respect to
awards of grants, cooperative agreements, and contracts under
this title, the Assistant Secretary, or the Director of the
Center involved, as the case may be, may not make such an award
unless--
(1) an application for the award is submitted to the
official involved;
(2) with respect to carrying out the purpose for
which the award is to be provided, the application
provides assurances of compliance satisfactory to such
official; and
(3) the application is otherwise in such form, is
made in such manner, and contains such agreements,
assurances, and information as the official determines
to be necessary to carry out the purpose for which the
award is to be provided.
(o) Emergency Response.--
(1) In general.--Notwithstanding section 504 and
except as provided in paragraph (2), the Secretary may
use not to exceed 2.5 percent of all amounts
appropriated under this title for a fiscal year to make
noncompetitive grants, contracts or cooperative
agreements to public entities to enable such entities
to address emergency substance abuse or mental health
needs in local communities.
(2) Exceptions.--Amounts appropriated under part C
shall not be subject to paragraph (1).
(3) Emergencies.--The Secretary shall establish
criteria for determining that a substance abuse or
mental health emergency exists and publish such
criteria in the Federal Register prior to providing
funds under this subsection.
(4) Emergency response.--Amounts made available for
carrying out this subsection shall remain available
through the end of the fiscal year following the fiscal
year for which such amounts are appropriated.
(p) Limitation on the Use of Certain Information.--No
information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the
course of activities undertaken or supported under section 505
may be used for any purpose other than the purpose for which it
was supplied unless such establishment or person has consented
(as determined under regulations of the Secretary) to its use
for such other purpose. Such information may not be published
or released in other form if the person who supplied the
information or who is described in it is identifiable unless
such person has consented (as determined under regulations of
the Secretary) to its publication or release in other form.
(q) Authorization of Appropriations.--For the purpose of
providing grants, cooperative agreements, and contracts under
this section, there are authorized to be appropriated
$25,000,000 for fiscal year 2001, and such sums as may be
necessary for each of the fiscal years 2002 and 2003.
SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
(a) In General.--There shall be established within the
Administration a National Mental Health and Substance Use
Policy Laboratory (referred to in this section as the
``Laboratory'').
(b) Responsibilities.--The Laboratory shall--
(1) continue to carry out the authorities and
activities that were in effect for the Office of
Policy, Planning, and Innovation as such Office existed
prior to the date of enactment of the Helping Families
in Mental Health Crisis Reform Act of 2016;
(2) identify, coordinate, and facilitate the
implementation of policy changes likely to have a
significant effect on mental health, mental illness,
recovery supports, and the prevention and treatment of
substance use disorder services;
(3) work with the Center for Behavioral Health
Statistics and Quality to collect, as appropriate,
information from grantees under programs operated by
the Administration in order to evaluate and disseminate
information on evidence-based practices, including
culturally and linguistically appropriate services, as
appropriate, and service delivery models;
(4) provide leadership in identifying and
coordinating policies and programs, including evidence-
based programs, related to mental and substance use
disorders;
(5) periodically review programs and activities
operated by the Administration relating to the
diagnosis or prevention of, treatment for, and recovery
from, mental and substance use disorders to--
(A) identify any such programs or activities
that are duplicative;
(B) identify any such programs or activities
that are not evidence-based, effective, or
efficient; and
(C) formulate recommendations for
coordinating, eliminating, or improving
programs or activities identified under
subparagraph (A) or (B) and merging such
programs or activities into other successful
programs or activities;
(6) issue and periodically update information for
entities applying for grants or cooperative agreements
from the Substance Abuse and Mental Health Services
Administration in order to--
(A) encourage the implementation and
replication of evidence-based practices; and
(B) provide technical assistance to
applicants for funding, including with respect
to justifications for such programs and
activities; and
(7) carry out other activities as deemed necessary to
continue to encourage innovation and disseminate
evidence-based programs and practices.
(c) Evidence-based Practices and Service Delivery Models.--
(1) In general.--In carrying out subsection (b)(3),
the Laboratory--
(A) may give preference to models that
improve--
(i) the coordination between mental
health and physical health providers;
(ii) the coordination among such
providers and the justice and
corrections system; and
(iii) the cost effectiveness,
quality, effectiveness, and efficiency
of health care services furnished to
adults with a serious mental illness,
children with a serious emotional
disturbance, or individuals in a mental
health crisis; and
(B) may include clinical protocols and
practices that address the needs of individuals
with early serious mental illness.
(2) Consultation.--In carrying out this section, the
Laboratory shall consult with--
(A) the Chief Medical Officer appointed under
section 501(g);
(B) representatives of the National Institute
of Mental Health, the National Institute on
Drug Abuse, and the National Institute on
Alcohol Abuse and Alcoholism, on an ongoing
basis;
(C) other appropriate Federal agencies;
(D) clinical and analytical experts with
expertise in psychiatric medical care and
clinical psychological care, health care
management, education, corrections health care,
and mental health court systems, as
appropriate; and
(E) other individuals and agencies as
determined appropriate by the Assistant
Secretary.
(d) Deadline for Beginning Implementation.--The Laboratory
shall begin implementation of this section not later than
January 1, 2018.
(e) Promoting Innovation.--
(1) In general.--The Assistant Secretary, in
coordination with the Laboratory, may award grants to
States, local governments, [Indian tribes or tribal
organizations] Indian Tribes or Tribal organizations
(as such terms are defined in section 4 of the Indian
Self-Determination and Education Assistance Act),
educational institutions, and nonprofit organizations
to develop evidence-based interventions, including
culturally and linguistically appropriate services, as
appropriate, for--
(A) evaluating a model that has been
scientifically demonstrated to show promise,
but would benefit from further applied
development, for--
(i) enhancing the prevention,
diagnosis, intervention, and treatment
of, and recovery from, mental illness,
serious emotional disturbances,
substance use disorders, and co-
occurring illness or disorders; or
(ii) integrating or coordinating
physical health services and mental and
substance use disorders services; and
(B) expanding, replicating, or scaling
evidence-based programs across a wider area to
enhance effective screening, early diagnosis,
intervention, and treatment with respect to
mental illness, serious mental illness, serious
emotional disturbances, and substance use
disorders, primarily by--
(i) applying such evidence-based
programs to the delivery of care,
including by training staff in
effective evidence-based treatments; or
(ii) integrating such evidence-based
programs into models of care across
specialties and jurisdictions.
(2) Consultation.--In awarding grants under this
subsection, the Assistant Secretary shall, as
appropriate, consult with the Chief Medical Officer,
appointed under section 501(g), the advisory councils
described in section 502, the National Institute of
Mental Health, the National Institute on Drug Abuse,
and the National Institute on Alcohol Abuse and
Alcoholism, as appropriate.
[(3) Authorization of appropriations.--There are
authorized to be appropriated--
[(A) to carry out paragraph (1)(A),
$7,000,000 for the period of fiscal years 2018
through 2020; and
[(B) to carry out paragraph (1)(B),
$7,000,000 for the period of fiscal years 2018
through 2020.]
(f) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $10,000,000 for
each of fiscal years 2023 through 2027.
SEC. 501B. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
COMMITTEE.
(a) Establishment.--
(1) In general.--The Secretary of Health and Human
Services, or the designee of the Secretary, shall
establish a committee to be known as the
Interdepartmental Serious Mental Illness Coordinating
Committee (in this section referred to as the
``Committee'').
(2) Federal advisory committee act.--Except as
provided in this section, the provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall apply to
the Committee.
(b) Meetings.--The Committee shall meet not fewer than 2
times each year.
(c) Responsibilities.--The Committee shall submit, on a
biannual basis, to Congress and any other relevant Federal
department or agency a report including--
(1) a summary of advances in serious mental illness
and serious emotional disturbance research related to
the prevention of, diagnosis of, intervention in, and
treatment and recovery of serious mental illnesses,
serious emotional disturbances, and advances in access
to services and support for adults with a serious
mental illness or children with a serious emotional
disturbance;
(2) an evaluation of the effect Federal programs
related to serious mental illness have on public
health, including public health outcomes such as--
(A) rates of suicide, suicide attempts,
incidence and prevalence of serious mental
illnesses, serious emotional disturbances, and
substance use disorders, overdose, overdose
deaths, emergency hospitalizations, emergency
room boarding, preventable emergency room
visits, interaction with the criminal justice
system, homelessness, and unemployment;
(B) increased rates of employment and
enrollment in educational and vocational
programs;
(C) quality of mental and substance use
disorders treatment services; or
(D) any other criteria as may be determined
by the Secretary; and
(3) specific recommendations for actions that
agencies can take to better coordinate the
administration of mental health services for adults
with a serious mental illness or children with a
serious emotional disturbance.
(d) Membership.--
(1) Federal members.--The Committee shall be composed
of the following Federal representatives, or the
designees of such representatives--
(A) the Secretary of Health and Human
Services, who shall serve as the Chair of the
Committee;
(B) the Assistant Secretary for Mental Health
and Substance Use;
(C) the Attorney General;
(D) the Secretary of Veterans Affairs;
(E) the Secretary of Defense;
(F) the Secretary of Housing and Urban
Development;
(G) the Secretary of Education;
(H) the Secretary of Labor;
(I) the Administrator of the Centers for
Medicare & Medicaid Services; and
(J) the Commissioner of Social Security.
(2) Non-federal members.--The Committee shall also
include not less than 14 non-Federal public members
appointed by the Secretary of Health and Human
Services, of which--
(A) at least 2 members shall be an individual
who has received treatment for a diagnosis of a
serious mental illness;
(B) at least 1 member shall be a parent or
legal guardian of an adult with a history of a
serious mental illness or a child with a
history of a serious emotional disturbance;
(C) at least 1 member shall be a
representative of a leading research, advocacy,
or service organization for adults with a
serious mental illness;
(D) at least 2 members shall be--
(i) a licensed psychiatrist with
experience in treating serious mental
illnesses;
(ii) a licensed psychologist with
experience in treating serious mental
illnesses or serious emotional
disturbances;
(iii) a licensed clinical social
worker with experience treating serious
mental illnesses or serious emotional
disturbances; or
(iv) a licensed psychiatric nurse,
nurse practitioner, or physician
assistant with experience in treating
serious mental illnesses or serious
emotional disturbances;
(E) at least 1 member shall be a licensed
mental health professional with a specialty in
treating children and adolescents with a
serious emotional disturbance;
(F) at least 1 member shall be a mental
health professional who has research or
clinical mental health experience in working
with minorities;
(G) at least 1 member shall be a mental
health professional who has research or
clinical mental health experience in working
with medically underserved populations;
(H) at least 1 member shall be a State
certified mental health peer support
specialist;
(I) at least 1 member shall be a judge with
experience in adjudicating cases related to
criminal justice or serious mental illness;
(J) at least 1 member shall be a law
enforcement officer or corrections officer with
extensive experience in interfacing with adults
with a serious mental illness, children with a
serious emotional disturbance, or individuals
in a mental health crisis; and
(K) at least 1 member shall have experience
providing services for homeless individuals and
working with adults with a serious mental
illness, children with a serious emotional
disturbance, or individuals in a mental health
crisis.
(3) Terms.--A member of the Committee appointed under
paragraph (2) shall serve for a term of 3 years, and
may be reappointed for 1 or more additional 3-year
terms. Any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of
such term. A member may serve after the expiration of
the member's term until a successor has been appointed.
(e) Working Groups.--In carrying out its functions, the
Committee may establish working groups. Such working groups
shall be composed of Committee members, or their designees, and
may hold such meetings as are necessary.
(f) Sunset.--The Committee shall terminate on September 30,
2027.
* * * * * * *
SEC. 506. GRANTS FOR THE BENEFIT OF HOMELESS INDIVIDUALS.
(a) In General.--The Secretary shall award grants, contracts
and cooperative agreements to community-based public and
private nonprofit entities for the purposes of providing mental
health and substance use disorder services for homeless
individuals. In carrying out this section, the Secretary shall
consult with the Interagency Council on the Homeless,
established under section 201 of the Stewart B. McKinney
Homeless Assistance Act (42 U.S.C. 11311).
(b) Preferences.--In awarding grants, contracts, and
cooperative agreements under subsection (a), the Secretary
shall give a preference to--
(1) entities that provide integrated primary health,
substance use disorder, and mental health services to
homeless individuals;
(2) entities that demonstrate effectiveness in
serving runaway, homeless, and street youth;
(3) entities that have experience in providing
substance use disorder and mental health services to
homeless individuals;
(4) entities that demonstrate experience in providing
housing for individuals in treatment for or in recovery
from mental illness or a substance use disorder; and
(5) entities that demonstrate effectiveness in
serving homeless veterans.
(c) Services for Certain Individuals.--In awarding grants,
contracts, and cooperative agreements under subsection (a), the
Secretary shall not--
(1) prohibit the provision of services under such
subsection to homeless individuals who are suffering
from a substance use disorder and are not suffering
from a mental health disorder; and
(2) make payments under subsection (a) to any entity
that has a policy of--
(A) excluding individuals from mental health
services due to the existence or suspicion of a
substance use disorder; or
(B) has a policy of excluding individuals
from substance use disorder services due to the
existence or suspicion of mental illness.
(d) Term of the Awards.--No entity may receive a grant,
contract, or cooperative agreement under subsection (a) for
more than 5 years.
(e) Authorization of Appropriations.--There is authorized to
be appropriated to carry out this section$41,304,000 for each
of fiscal years [2018 through 2022] 2023 through 2027.
[SEC. 506A. ALCOHOL AND DRUG PREVENTION OR TREATMENT SERVICES FOR
INDIANS AND NATIVE ALASKANS.
[(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to public and private
nonprofit entities, including Native Alaskan entities and
Indian tribes and tribal organizations, for the purpose of
providing alcohol and drug prevention or treatment services for
Indians and Native Alaskans.
[(b) Priority.--In awarding grants, contracts, or cooperative
agreements under subsection (a), the Secretary shall give
priority to applicants that--
[(1) propose to provide alcohol and drug prevention
or treatment services on reservations;
[(2) propose to employ culturally-appropriate
approaches, as determined by the Secretary, in
providing such services; and
[(3) have provided prevention or treatment services
to Native Alaskan entities and Indian tribes and tribal
organizations for at least 1 year prior to applying for
a grant under this section.
[(c) Duration.--The Secretary shall award grants, contracts,
or cooperative agreements under subsection (a) for a period not
to exceed 5 years.
[(d) Application.--An entity desiring a grant, contract, or
cooperative agreement under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
[(e) Evaluation.--An entity that receives a grant, contract,
or cooperative agreement under subsection (a) shall submit, in
the application for such grant, a plan for the evaluation of
any project undertaken with funds provided under this section.
Such entity shall provide the Secretary with periodic
evaluations of the progress of such project and such evaluation
at the completion of such project as the Secretary determines
to be appropriate. The final evaluation submitted by such
entity shall include a recommendation as to whether such
project shall continue.
[(f) Report.--Not later than 3 years after the date of the
enactment of this section and annually thereafter, the
Secretary shall prepare and submit, to the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
describing the services provided pursuant to this section.
[(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $15,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 and 2003.]
SEC. 506A. BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER SERVICES FOR
NATIVE AMERICANS.
(a) Definitions.--In this section:
(1) The term ``eligible entity'' means an Indian
Tribe, a Tribal organization, an Urban Indian
organization, and a Native Hawaiian health
organization.
(2) The terms ``Indian Tribe'', ``Tribal
organization'', and ``Urban Indian organization'' have
the meanings given to the terms ``Indian tribe'',
``tribal organization'', and ``Urban Indian
organization'' in section 4 of the Indian Health Care
Improvement Act.
(3) The term ``Native Hawaiian health organization''
means ``Papa Ola Lokahi'' as defined in section 12 of
the Native Hawaiian Health Care Improvement Act.
(b) Formula Funds.--
(1) In general.--The Secretary, in consultation with
the Director of the Indian Health Service, as
appropriate, shall award funds to eligible entities, in
amounts determined pursuant to the formula described in
paragraph (2), to be used by the eligible entity to
provide culturally appropriate mental health and
substance use disorder prevention, treatment, and
recovery services to American Indians, Alaska Natives,
and Native Hawaiians.
(2) Formula.--The Secretary, using the process
described in subsection (d), shall develop a formula to
determine the amount of an award under paragraph (1).
Such formula shall take into account the populations of
eligible entities whose rates of overdose deaths or
suicide are substantially higher relative to the
populations of other Indian Tribes, Tribal
organizations, Urban Indian organizations, or Native
Hawaiian health organizations, as applicable.
(c) Technical Assistance and Program Evaluation.--
(1) In general.--The Secretary shall--
(A) provide technical assistance to
applicants and awardees under this section; and
(B) collect and evaluate information on the
program carried out under this section.
(2) Consultation on evaluation measures, and data
submission and reporting requirements.--The Secretary
shall, using the process described in subsection (d),
develop evaluation measures and data submission and
reporting requirements for purposes of the collection
and evaluation of information.
(3) Data submission and reporting.--As a condition on
receipt of funds under this section, an applicant shall
agree to submit data and reports in a timely manner
consistent with the evaluation measures and data
submission and reporting requirements developed under
subsection (d).
(d) Regulations.--
(1) Promulgation.--Not later than 180 days after the
date of enactment of the Restoring Hope for Mental
Health and Well-Being Act of 2022, the Secretary shall
initiate procedures under subchapter III of chapter 5
of title 5, United States Code, to negotiate and
promulgate such regulations as are necessary to carry
out this section, including development of the funding
formula described in subsection (b) and the program
evaluation and reporting requirements under subsection
(c).
(2) Publication.--Not later than 18 months after the
date of enactment of the Restoring Hope for Mental
Health and Well-Being Act of 2022, the Secretary shall
publish in the Federal Register proposed regulations to
implement this section.
(3) Committee.--A negotiated rulemaking committee
established pursuant to section 565 of title 5, United
States Code, to carry out this subsection shall have as
its members only representatives of the Federal
Government, Tribal Governments, and Urban Indian
organizations. For purposes of such rulemaking, the
Indian Health Service shall be the lead agency for the
Department.
(4) Adaptation of procedures.--In carrying out this
subsection, the Secretary shall adapt any negotiated
rulemaking procedures to the unique context of the
government-to-government relationship between the
United States and Indian Tribes.
(5) Effect.--The lack of promulgated regulations
under this subsection shall not limit the effect or
implementation of this section.
(e) Application.--An entity desiring an award under
subsection (b) shall submit an application to the Secretary at
such time, in such manner, and accompanied by such information
as the Secretary may reasonably require.
(f) Report.--Not later than 3 years after the date of the
enactment of the Restoring Hope for Mental Health and Well-
Being Act of 2022, and annually thereafter, the Secretary shall
prepare and submit, to the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on Energy
and Commerce of the House of Representatives, a report
describing the services provided pursuant to this section.
(g) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, $40,000,000 for each
of fiscal years 2023 through 2027.
SEC. 506B. BEHAVIORAL HEALTH CRISIS COORDINATING OFFICE.
(a) In General.--The Secretary shall establish, within the
Substance Abuse and Mental Health Services Administration, an
office to coordinate work relating to behavioral health crisis
care across the operating divisions and agencies of the
Department of Health and Human Services, including the
Substance Abuse and Mental Health Services Administration, the
Centers for Medicare & Medicaid Services, and the Health
Resources and Services Administration, and external
stakeholders.
(b) Duty.--The office established under subsection (a)
shall--
(1) convene Federal, State, Tribal, local, and
private partners;
(2) launch and manage Federal workgroups charged with
making recommendations regarding behavioral health
crisis issues, including with respect to health care
best practices, workforce development, mental health
disparities, data collection, technology, program
oversight, public awareness, and engagement; and
(3) support technical assistance, data analysis, and
evaluation functions in order to assist States,
localities, Territories, Tribes, and Tribal communities
to develop crisis care systems and establish nationwide
best practices with the objective of expanding the
capacity of, and access to, local crisis call centers,
mobile crisis care, crisis stabilization, psychiatric
emergency services, and rapid post-crisis follow-up
care provided by--
(A) the National Suicide Prevention and
Mental Health Crisis Hotline and Response
System;
(B) community mental health centers (as
defined in section 1861(ff)(3)(B) of the Social
Security Act);
(C) certified community behavioral health
clinics, as described in section 223 of the
Protecting Access to Medicare Act of 2014; and
(D) other community mental health and
substance use disorder providers.
(c) Authorization of Appropriations.--There is authorized to
be appropriated to carry out this section $5,000,000 for each
of fiscal years 2023 through 2027.
Part B--Centers and Programs
Subpart 1--Center for Substance Abuse Treatment
* * * * * * *
SEC. 509. PRIORITY SUBSTANCE [ABUSE] USE DISORDER TREATMENT NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority substance
use disorder treatment needs of regional and national
significance (as determined under subsection (b)) through the
provision of or through assistance for--
(1) knowledge development and application projects
for treatment and rehabilitation and the conduct or
support of evaluations of such projects;
(2) training and technical assistance; and
(3) targeted capacity response programs that permit
States, local governments, communities, and Indian
[tribes and tribal organizations (as the terms ``Indian
tribes'' and ``tribal organizations'' are defined]
Tribes and Tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination
and Education Assistance Act) to focus on emerging
trends [in substance abuse] and co-occurrence of
substance use disorders with mental illness or other
conditions.
The Secretary may carry out the activities described in this
section directly or through grants, contracts, or cooperative
agreements with States, political subdivisions of States,
Indian tribes or tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination and
Education Assistance Act), health facilities, or programs
operated by or in accordance with a contract or grant with the
Indian Health Service, or other public or nonprofit private
entities.
(b) Priority Substance [Abuse] Use Disorder Treatment
Needs.--
(1) In general.--Priority substance use disorder
treatment needs of regional and national significance
shall be determined by the Secretary after consultation
with States and other interested groups. The Secretary
shall meet with the States and interested groups on an
annual basis to discuss program priorities.
(2) Special consideration.--In developing program
priorities under paragraph (1), the Secretary shall
give special consideration to promoting the integration
of substance use disorder treatment services into
primary health care systems.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts, or
cooperative agreements under this section shall comply
with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for projects
carried out under subsection (a), require that entities
that apply for grants, contracts, or cooperative
agreements under that project provide non-Federal
matching funds, as determined appropriate by the
Secretary, to ensure the institutional commitment of
the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract, or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--The Secretary shall establish
comprehensive information and education programs to disseminate
and apply the findings of the knowledge development and
application, training and technical assistance programs, and
targeted capacity response programs under this section to the
general public, to health professionals and other interested
groups. The Secretary shall make every effort to provide
linkages between the findings of supported projects and State
agencies responsible for carrying out substance use disorder
prevention and treatment programs.
(f) Authorization of Appropriation.--There are authorized to
be appropriated to carry out this section, [$333,806,000 for
each of fiscal years 2018 through 2022] $521,517,000 for each
of fiscal years 2023 through 2027.
* * * * * * *
SEC. 514. SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION
SERVICES FOR CHILDREN, ADOLESCENTS, AND YOUNG
ADULTS.
(a) In General.--The Secretary shall award grants, contracts,
or cooperative agreements to public and private nonprofit
entities, including [Indian tribes or tribal organizations]
Indian Tribes or Tribal organizations (as such terms are
defined in section 4 of the Indian Self-Determination and
Education Assistance Act), or health facilities or programs
operated by or in accordance with a contract or grant with the
Indian Health Service, for the purpose of--
(1) providing early identification and services to
meet the needs of children, adolescents, and young
adults who are at risk of substance use disorders;
(2) providing substance use disorder treatment
services for children, adolescents, and young adults,
includingchildren, adolescents, and young adults with
co-occurring mental illness and substance use
disorders; and
(3) providing assistance to pregnant women, and
parenting women, with substance use disorders, in
obtaining treatment services, linking mothers to
community resources to support independent family
lives, and staying in recovery so that children are in
safe, stable home environments and receive appropriate
health care services.
(b) Priority.--In awarding grants, contracts, or cooperative
agreements under subsection (a), the Secretary shall give
priority to applicants who propose to--
(1) apply evidence-based and cost-effective methods;
(2) coordinate the provision of services with other
social service agencies in the community, including
educational, juvenile justice, child welfare, substance
abuse, and mental health agencies;
(3) provide a continuum of integrated treatment
services, including case management, for children,
adolescents, and young adults with substance use
disorders, including children, adolescents, and young
adults with co-occurring mental illness and substance
use disorders, and their families;
(4) provide treatment that is gender-specific and
culturally appropriate;
(5) involve and work with families of children,
adolescents, and young adults receiving services; and
(6) provide aftercare services for children,
adolescents, and young adults and their families after
completion of treatment.
(c) Duration of Grants.--The Secretary shall award grants,
contracts, or cooperative agreements under subsection (a) for
periods not to exceed 5 fiscal years.
(d) Application.--An entity desiring a grant, contract, or
cooperative agreement under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
(e) Evaluation.--An entity that receives a grant, contract,
or cooperative agreement under subsection (a) shall submit, in
the application for such grant, contract, or cooperative
agreement, a plan for the evaluation of any project undertaken
with funds provided under this section. Such entity shall
provide the Secretary with periodic evaluations of the progress
of such project and such evaluation at the completion of such
project as the Secretary determines to be appropriate.
(f) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, $29,605,000 for each
of fiscal years [2018 through 2022] 2023 through 2027.
SEC. 514B. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND
INTERVENTIONS DEMONSTRATION.
(a) Grants to Expand Access.--
(1) Authority to award grants.--The Secretary shall
award grants, contracts, or cooperative agreements to
State [substance abuse] substance use disorder
agencies, units of local government, nonprofit
organizations, and Indian [tribes and tribal
organizations] Tribes and Tribal organizations (as
defined in section 4 of the Indian Self-Determination
and Education Assistance Act) that have a high rate, or
have had a rapid increase, in the use of heroin or
other opioids, in order to permit such entities to
expand activities, including an expansion in the
availability of evidence-based medication-assisted
treatment and other clinically appropriate services,
with respect to the treatment of [addiction] substance
use disorders in the specific geographical areas of
such entities where there is a high rate or rapid
increase in the use of heroin or other opioids, such as
in rural areas.
(2) Nature of activities.--Funds awarded under
paragraph (1) shall be used for activities that are
based on reliable scientific evidence of efficacy in
the treatment of problems related to heroin or other
opioids.
(b) Application.--To be eligible for a grant, contract, or
cooperative agreement under subsection (a), an entity shall
submit an application to the Secretary at such time, in such
manner, and accompanied by such information as the Secretary
may reasonably require.
(c) Evaluation.--An entity that receives a grant, contract,
or cooperative agreement under subsection (a) shall submit, in
the application for such grant, contract, or agreement a plan
for the evaluation of any project undertaken with funds
provided under this section. Such entity shall provide the
Secretary with periodic evaluations of the progress of such
project and an evaluation at the completion of such project as
the Secretary determines to be appropriate.
(d) Geographic Distribution.--In awarding grants, contracts,
and cooperative agreements under this section, the Secretary
shall ensure that not less than 15 percent of funds are awarded
to eligible entities that are not located in metropolitan
statistical areas (as defined by the Office of Management and
Budget). The Secretary shall take into account the unique needs
of rural communities, including communities with an incidence
of individuals with opioid use disorder that is above the
national average and communities with a shortage of prevention
and treatment services.
(e) Additional Activities.--In administering grants,
contracts, and cooperative agreements under subsection (a), the
Secretary shall--
(1) evaluate the activities supported under such
subsection;
(2) disseminate information, as appropriate, derived
from evaluations as the Secretary considers
appropriate;
(3) provide States, Indian [tribes and tribal
organizations] Tribes and Tribal organizations, and
providers with technical assistance in connection with
the provision of treatment of problems related to
heroin and other opioids; and
(4) fund only those applications that specifically
support recovery services as a critical component of
the program involved.
(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $25,000,000
for each of fiscal years [2017 through 2021] 2023 through 2027.
Subpart 2--Center for Substance Abuse Prevention
* * * * * * *
SEC. 516. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS OF REGIONAL
AND NATIONAL SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority substance
use disorder prevention needs of regional and national
significance (as determined under subsection (b)) through the
provision of or through assistance for--
(1) knowledge development and application projects
for prevention and the conduct or support of
evaluations of such projects;
(2) training and technical assistance; and
(3) targeted capacity response programs, including
such programs that focus on emerging drug [abuse] use
issues.
The Secretary may carry out the activities described in this
section directly or through grants, contracts, or cooperative
agreements with States, political subdivisions of States,
Indian [tribes or tribal organizations] Tribes or Tribal
organizations (as such terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act), health
facilities, or programs operated by or in accordance with a
contract or grant with the Indian Health Service, or other
public or nonprofit private entities.
(b) Priority Substance [Abuse] Use Disorder Prevention
Needs.--
(1) In general.--Priority substance use disorder
prevention needs of regional and national significance
shall be determined by the Secretary in consultation
with the States and other interested groups. The
Secretary shall meet with the States and interested
groups on an annual basis to discuss program
priorities.
(2) Special consideration.--In developing program
priorities under paragraph (1), the Secretary shall
give special consideration to--
(A) applying the most promising strategies
and research-based primary prevention
approaches;
(B) promoting the integration of substance
use disorder prevention information and
activities into primary health care systems;
and
(C) substance use disorder prevention among
high-risk groups.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts, and
cooperative agreements under this section shall comply
with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for projects
carried out under subsection (a), require that entities
that apply for grants, contracts, or cooperative
agreements under that project provide non-Federal
matching funds, as determined appropriate by the
Secretary, to ensure the institutional commitment of
the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract, or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--The Secretary shall establish
comprehensive information and education programs to disseminate
the findings of the knowledge development and application,
training and technical assistance programs, and targeted
capacity response programs under this section to the general
public and to health professionals. The Secretary shall make
every effort to provide linkages between the findings of
supported projects and State agencies responsible for carrying
out substance use disorder prevention and treatment programs.
(f) Authorization of Appropriation.--There are authorized to
be appropriated to carry out this section, [$211,148,000 for
each of fiscal years 2018 through 2022] $218,219,000 for each
of fiscal years 2023 through 2027.
SEC. 519B. PROGRAMS TO REDUCE UNDERAGE DRINKING.
[(a) Definitions.--For purposes of this section:
[(1) The term ``alcohol beverage industry'' means the
brewers, vintners, distillers, importers, distributors,
and retail or online outlets that sell or serve beer,
wine, and distilled spirits.
[(2) The term ``school-based prevention'' means
programs, which are institutionalized, and run by staff
members or school-designated persons or organizations
in any grade of school, kindergarten through 12th
grade.
[(3) The term ``youth'' means persons under the age
of 21.
[(4) The term ``IOM report'' means the report
released in September 2003 by the National Research
Council, Institute of Medicine, and entitled ``Reducing
Underage Drinking: A Collective Responsibility''.]
(a) Definitions.--For purposes of this section:
(1) The term ``alcohol beverage industry'' means the
brewers, vintners, distillers, importers, distributors,
and retail or online outlets that sell or serve beer,
wine, and distilled spirits.
(2) The term ``school-based prevention'' means
programs, which are institutionalized, and run by staff
members or school-designated persons or organizations
in any grade of school, kindergarten through 12th
grade.
(3) The term ``youth'' means persons under the age of
21.
(b) Sense of Congress.--It is the sense of the Congress that:
(1) A multi-faceted effort is needed to more
successfully address the problem of underage drinking
in the United States. A coordinated approach to
prevention, intervention, treatment, enforcement, and
research is key to making progress. This Act recognizes
the need for a focused national effort, and addresses
particulars of the Federal portion of that effort, as
well as Federal support for State activities.
(2) The Secretary of Health and Human Services shall
continue to conduct research and collect data on the
short and long-range impact of alcohol use and abuse
upon adolescent brain development and other organ
systems.
(3) States and communities, including colleges and
universities, are encouraged to adopt comprehensive
prevention approaches, including--
(A) evidence-based screening, programs and
curricula;
(B) brief intervention strategies;
(C) consistent policy enforcement; and
(D) environmental changes that limit underage
access to alcohol.
(4) Public health groups, consumer groups, and the
alcohol beverage industry should continue and expand
evidence-based efforts to prevent and reduce underage
drinking.
(5) The entertainment industries have a powerful
impact on youth, and they should use rating systems and
marketing codes to reduce the likelihood that underage
audiences will be exposed to movies, recordings, or
television programs with unsuitable alcohol content.
(6) The National Collegiate Athletic Association, its
member colleges and universities, and athletic
conferences should affirm a commitment to a policy of
discouraging alcohol use among underage students and
other young fans.
(7) Alcohol is a unique product and should be
regulated differently than other products by the States
and Federal Government. States have primary authority
to regulate alcohol distribution and sale, and the
Federal Government should support and supplement these
State efforts. States also have a responsibility to
fight youth access to alcohol and reduce underage
drinking. Continued State regulation and licensing of
the manufacture, importation, sale, distribution,
transportation and storage of alcoholic beverages are
clearly in the public interest and are critical to
promoting responsible consumption, preventing illegal
access to alcohol by persons under 21 years of age from
commercial and non-commercial sources, maintaining
industry integrity and an orderly marketplace, and
furthering effective State tax collection.
[(c) Interagency Coordinating Committee; Annual Report on
State Underage Drinking Prevention and Enforcement
Activities.--
[(1) Interagency coordinating committee on the
prevention of underage drinking.--
[(A) In general.--The Secretary, in
collaboration with the Federal officials
specified in subparagraph (B), shall formally
establish and enhance the efforts of the
interagency coordinating committee, that began
operating in 2004, focusing on underage
drinking (referred to in this subsection as the
``Committee'').
[(B) Other agencies.--The officials referred
to in paragraph (1) are the Secretary of
Education, the Attorney General, the Secretary
of Transportation, the Secretary of the
Treasury, the Secretary of Defense, the Surgeon
General, the Director of the Centers for
Disease Control and Prevention, the Director of
the National Institute on Alcohol Abuse and
Alcoholism, the Assistant Secretary for Mental
Health and Substance Use, the Director of the
National Institute on Drug Abuse, the Assistant
Secretary for Children and Families, the
Director of the Office of National Drug Control
Policy, the Administrator of the National
Highway Traffic Safety Administration, the
Administrator of the Office of Juvenile Justice
and Delinquency Prevention, the Chairman of the
Federal Trade Commission, and such other
Federal officials as the Secretary of Health
and Human Services determines to be
appropriate.
[(C) Chair.--The Secretary of Health and
Human Services shall serve as the chair of the
Committee.
[(D) Duties.--The Committee shall guide
policy and program development across the
Federal Government with respect to underage
drinking, provided, however, that nothing in
this section shall be construed as transferring
regulatory or program authority from an Agency
to the Coordinating Committee.
[(E) Consultations.--The Committee shall
actively seek the input of and shall consult
with all appropriate and interested parties,
including States, public health research and
interest groups, foundations, and alcohol
beverage industry trade associations and
companies.
[(F) Annual report.--
[(i) In general.--The Secretary, on
behalf of the Committee, shall annually
submit to the Congress a report that
summarizes--
[(I) all programs and
policies of Federal agencies
designed to prevent and reduce
underage drinking;
[(II) the extent of progress
in preventing and reducing
underage drinking nationally;
[(III) data that the
Secretary shall collect with
respect to the information
specified in clause (ii); and
[(IV) such other information
regarding underage drinking as
the Secretary determines to be
appropriate.
[(ii) Certain information.--The
report under clause (i) shall include
information on the following:
[(I) Patterns and
consequences of underage
drinking as reported in
research and surveys such as,
but not limited to Monitoring
the Future, Youth Risk Behavior
Surveillance System, the
National Survey on Drug Use and
Health, and the Fatality
Analysis Reporting System.
[(II) Measures of the
availability of alcohol from
commercial and non-commercial
sources to underage
populations.
[(III) Measures of the
exposure of underage
populations to messages
regarding alcohol in
advertising and the
entertainment media as reported
by the Federal Trade
Commission.
[(IV) Surveillance data,
including information on the
onset and prevalence of
underage drinking, consumption
patterns and the means of
underage access. The Secretary
shall develop a plan to improve
the collection, measurement and
consistency of reporting
Federal underage alcohol data.
[(V) Any additional findings
resulting from research
conducted or supported under
subsection (f).
[(VI) Evidence-based best
practices to prevent and reduce
underage drinking and provide
treatment services to those
youth who need them.
[(2) Annual report on state underage drinking
prevention and enforcement activities.--
[(A) In general.--The Secretary shall, with
input and collaboration from other appropriate
Federal agencies, States, Indian tribes,
territories, and public health, consumer, and
alcohol beverage industry groups, annually
issue a report on each State's performance in
enacting, enforcing, and creating laws,
regulations, and programs to prevent or reduce
underage drinking.
[(B) State performance measures.--
[(i) In general.--The Secretary shall
develop, in consultation with the
Committee, a set of measures to be used
in preparing the report on best
practices.
[(ii) Categories.--In developing
these measures, the Secretary shall
consider categories including, but not
limited to:
[(I) Whether or not the State
has comprehensive anti-underage
drinking laws such as for the
illegal sale, purchase, attempt
to purchase, consumption, or
possession of alcohol; illegal
use of fraudulent ID; illegal
furnishing or obtaining of
alcohol for an individual under
21 years; the degree of
strictness of the penalties for
such offenses; and the
prevalence of the enforcement
of each of these infractions.
[(II) Whether or not the
State has comprehensive
liability statutes pertaining
to underage access to alcohol
such as dram shop, social host,
and house party laws, and the
prevalence of enforcement of
each of these laws.
[(III) Whether or not the
State encourages and conducts
comprehensive enforcement
efforts to prevent underage
access to alcohol at retail
outlets, such as random
compliance checks and shoulder
tap programs, and the number of
compliance checks within
alcohol retail outlets measured
against the number of total
alcohol retail outlets in each
State, and the result of such
checks.
[(IV) Whether or not the
State encourages training on
the proper selling and serving
of alcohol for all sellers and
servers of alcohol as a
condition of employment.
[(V) Whether or not the State
has policies and regulations
with regard to direct sales to
consumers and home delivery of
alcoholic beverages.
[(VI) Whether or not the
State has programs or laws to
deter adults from purchasing
alcohol for minors; and the
number of adults targeted by
these programs.
[(VII) Whether or not the
State has programs targeted to
youths, parents, and caregivers
to deter underage drinking; and
the number of individuals
served by these programs.
[(VIII) Whether or not the
State has enacted graduated
drivers licenses and the extent
of those provisions.
[(IX) The amount that the
State invests, per youth
capita, on the prevention of
underage drinking, further
broken down by the amount spent
on--
[(aa) compliance
check programs in
retail outlets,
including providing
technology to prevent
and detect the use of
false identification by
minors to make alcohol
purchases;
[(bb) checkpoints and
saturation patrols that
include the goal of
reducing and deterring
underage drinking;
[(cc) community-
based, school-based,
and higher-education-
based programs to
prevent underage
drinking;
[(dd) underage
drinking prevention
programs that target
youth within the
juvenile justice and
child welfare systems;
and
[(ee) other State
efforts or programs as
deemed appropriate.
[(3) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection $1,000,000 for each of the fiscal years 2018
through 2022.
[(d) National Media Campaign To Prevent Underage Drinking.--
[(1) Scope of the campaign.--The Secretary shall
continue to fund and oversee the production,
broadcasting, and evaluation of the national adult-
oriented media public service campaign if the Secretary
determines that such campaign is effective in achieving
the media campaign's measurable objectives.
[(2) Report.--The Secretary shall provide a report to
the Congress annually detailing the production,
broadcasting, and evaluation of the campaign referred
to in paragraph (1), and to detail in the report the
effectiveness of the campaign in reducing underage
drinking, the need for and likely effectiveness of an
expanded adult-oriented media campaign, and the
feasibility and the likely effectiveness of a national
youth-focused media campaign to combat underage
drinking.
[(3) Consultation requirement.--In carrying out the
media campaign, the Secretary shall direct the entity
carrying out the national adult-oriented media public
service campaign to consult with interested parties
including both the alcohol beverage industry and public
health and consumer groups. The progress of this
consultative process is to be covered in the report
under paragraph (2).
[(4) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection, $1,000,000 for each of the fiscal years
2018 through 2022.
[(e) Interventions.--
[(1) Community-based coalition enhancement grants to
prevent underage drinking.--
[(A) Authorization of program.--The Assistant
Secretary for Mental Health and Substance Use,
in consultation with the Director of the Office
of National Drug Control Policy, shall award,
if the Assistant Secretary determines that the
Department of Health and Human Services is not
currently conducting activities that duplicate
activities of the type described in this
subsection, ``enhancement grants'' to eligible
entities to design, test, evaluate and
disseminate effective strategies to maximize
the effectiveness of community-wide approaches
to preventing and reducing underage drinking.
This subsection is subject to the availability
of appropriations.
[(B) Purposes.--The purposes of this
paragraph are to--
[(i) prevent and reduce alcohol use
among youth in communities throughout
the United States;
[(ii) strengthen collaboration among
communities, the Federal Government,
and State, local, and tribal
governments;
[(iii) enhance intergovernmental
cooperation and coordination on the
issue of alcohol use among youth;
[(iv) serve as a catalyst for
increased citizen participation and
greater collaboration among all sectors
and organizations of a community that
first demonstrates a long-term
commitment to reducing alcohol use
among youth;
[(v) disseminate to communities
timely information regarding state-of-
the-art practices and initiatives that
have proven to be effective in
preventing and reducing alcohol use
among youth; and
[(vi) enhance, not supplant,
effective local community initiatives
for preventing and reducing alcohol use
among youth.
[(C) Application.--An eligible entity
desiring an enhancement grant under this
paragraph shall submit an application to the
Assistant Secretary at such time, and in such
manner, and accompanied by such information as
the Assistant Secretary may require. Each
application shall include--
[(i) a complete description of the
entity's current underage alcohol use
prevention initiatives and how the
grant will appropriately enhance the
focus on underage drinking issues; or
[(ii) a complete description of the
entity's current initiatives, and how
it will use this grant to enhance those
initiatives by adding a focus on
underage drinking prevention.
[(D) Uses of funds.--Each eligible entity
that receives a grant under this paragraph
shall use the grant funds to carry out the
activities described in such entity's
application submitted pursuant to subparagraph
(C). Grants under this paragraph shall not
exceed $50,000 per year and may not exceed four
years.
[(E) Supplement not supplant.--Grant funds
provided under this paragraph shall be used to
supplement, not supplant, Federal and non-
Federal funds available for carrying out the
activities described in this paragraph.
[(F) Evaluation.--Grants under this paragraph
shall be subject to the same evaluation
requirements and procedures as the evaluation
requirements and procedures imposed on
recipients of drug free community grants.
[(G) Definitions.--For purposes of this
paragraph, the term ``eligible entity'' means
an organization that is currently receiving or
has received grant funds under the Drug-Free
Communities Act of 1997 (21 U.S.C. 1521 et
seq.).
[(H) Administrative expenses.--Not more than
6 percent of a grant under this paragraph may
be expended for administrative expenses.
[(I) Authorization of appropriations.--There
are authorized to be appropriated to carry out
this paragraph $5,000,000 for each of the
fiscal years 2018 through 2022.
[(2) Grants directed at preventing and reducing
alcohol abuse at institutions of higher education.--
[(A) Authorization of program.--The Secretary
shall award grants to eligible entities to
enable the entities to prevent and reduce the
rate of underage alcohol consumption including
binge drinking among students at institutions
of higher education.
[(B) Applications.--An eligible entity that
desires to receive a grant under this paragraph
shall submit an application to the Secretary at
such time, in such manner, and accompanied by
such information as the Secretary may require.
Each application shall include--
[(i) a description of how the
eligible entity will work to enhance an
existing, or where none exists to build
a, statewide coalition;
[(ii) a description of how the
eligible entity will target underage
students in the State;
[(iii) a description of how the
eligible entity intends to ensure that
the statewide coalition is actually
implementing the purpose of this
section and moving toward indicators
described in subparagraph (D);
[(iv) a list of the members of the
statewide coalition or interested
parties involved in the work of the
eligible entity;
[(v) a description of how the
eligible entity intends to work with
State agencies on substance abuse
prevention and education;
[(vi) the anticipated impact of funds
provided under this paragraph in
preventing and reducing the rates of
underage alcohol use;
[(vii) outreach strategies, including
ways in which the eligible entity
proposes to--
[(I) reach out to students
and community stakeholders;
[(II) promote the purpose of
this paragraph;
[(III) address the range of
needs of the students and the
surrounding communities; and
[(IV) address community norms
for underage students regarding
alcohol use; and
[(viii) such additional information
as required by the Secretary.
[(C) Uses of funds.--Each eligible entity
that receives a grant under this paragraph
shall use the grant funds to carry out the
activities described in such entity's
application submitted pursuant to subparagraph
(B).
[(D) Accountability.--On the date on which
the Secretary first publishes a notice in the
Federal Register soliciting applications for
grants under this paragraph, the Secretary
shall include in the notice achievement
indicators for the program authorized under
this paragraph. The achievement indicators
shall be designed--
[(i) to measure the impact that the
statewide coalitions assisted under
this paragraph are having on the
institutions of higher education and
the surrounding communities, including
changes in the number of incidents of
any kind in which students have abused
alcohol or consumed alcohol while under
the age of 21 (including violations,
physical assaults, sexual assaults,
reports of intimidation, disruptions of
school functions, disruptions of
student studies, mental health
referrals, illnesses, or deaths);
[(ii) to measure the quality and
accessibility of the programs or
information offered by the eligible
entity; and
[(iii) to provide such other measures
of program impact as the Secretary
determines appropriate.
[(E) Supplement not supplant.--Grant funds
provided under this paragraph shall be used to
supplement, and not supplant, Federal and non-
Federal funds available for carrying out the
activities described in this paragraph.
[(F) Definitions.--For purposes of this
paragraph:
[(i) Eligible entity.--The term
``eligible entity'' means a State,
institution of higher education, or
nonprofit entity.
[(ii) Institution of higher
education.--The term ``institution of
higher education'' has the meaning
given the term in section 101(a) of the
Higher Education Act of 1965 (20 U.S.C.
1001(a)).
[(iii) Secretary.--The term
``Secretary'' means the Secretary of
Education.
[(iv) State.--The term ``State''
means each of the 50 States, the
District of Columbia, and the
Commonwealth of Puerto Rico.
[(v) Statewide coalition.--The term
``statewide coalition'' means a
coalition that--
[(I) includes, but is not
limited to--
[(aa) institutions of
higher education within
a State; and
[(bb) a nonprofit
group, a community
underage drinking
prevention coalition,
or another substance
abuse prevention group
within a State; and
[(II) works toward lowering
the alcohol abuse rate by
targeting underage students at
institutions of higher
education throughout the State
and in the surrounding
communities.
[(vi) Surrounding community.--The
term ``surrounding community'' means
the community--
[(I) that surrounds an
institution of higher education
participating in a statewide
coalition;
[(II) where the students from
the institution of higher
education take part in the
community; and
[(III) where students from
the institution of higher
education live in off-campus
housing.
[(G) Administrative expenses.--Not more than
5 percent of a grant under this paragraph may
be expended for administrative expenses.
[(H) Authorization of appropriations.--There
are authorized to be appropriated to carry out
this paragraph $5,000,000 for fiscal year 2007,
and $5,000,000 for each of the fiscal years
2008 through 2010.
[(f) Additional Research.--
[(1) Additional research on underage drinking.--
[(A) In general.--The Secretary shall,
subject to the availability of appropriations,
collect data, and conduct or support research
that is not duplicative of research currently
being conducted or supported by the Department
of Health and Human Services, on underage
drinking, with respect to the following:
[(i) Comprehensive community-based
programs or strategies and statewide
systems to prevent and reduce underage
drinking, across the underage years
from early childhood to age 21,
including programs funded and
implemented by government entities,
public health interest groups and
foundations, and alcohol beverage
companies and trade associations.
[(ii) Annually obtain and report more
precise information than is currently
collected on the scope of the underage
drinking problem and patterns of
underage alcohol consumption, including
improved knowledge about the problem
and progress in preventing, reducing
and treating underage drinking; as well
as information on the rate of exposure
of youth to advertising and other media
messages encouraging and discouraging
alcohol consumption.
[(iii) Compiling information on the
involvement of alcohol in unnatural
deaths of persons ages 12 to 20 in the
United States, including suicides,
homicides, and unintentional injuries
such as falls, drownings, burns,
poisonings, and motor vehicle crash
deaths.
[(B) Certain matters.--The Secretary shall
carry out activities toward the following
objectives with respect to underage drinking:
[(i) Obtaining new epidemiological
data within the national or targeted
surveys that identify alcohol use and
attitudes about alcohol use during pre-
and early adolescence, including harm
caused to self or others as a result of
adolescent alcohol use such as
violence, date rape, risky sexual
behavior, and prenatal alcohol
exposure.
[(ii) Developing or identifying
successful clinical treatments for
youth with alcohol problems.
[(C) Peer review.--Research under
subparagraph (A) shall meet current Federal
standards for scientific peer review.
[(2) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection $3,000,000 for each of the fiscal years 2018
through 2022
[(g) Reducing Underage Drinking Through Screening and Brief
Intervention.--
[(1) Grants to pediatric health care providers to
reduce underage drinking.--The Assistant Secretary may
make grants to eligible entities to increase
implementation of practices for reducing the prevalence
of alcohol use among individuals under the age of 21,
including college students.
[(2) Purposes.--Grants under this subsection shall be
made to improve--
[(A) screening children and adolescents for
alcohol use;
[(B) offering brief interventions to children
and adolescents to discourage such use;
[(C) educating parents about the dangers of,
and methods of discouraging, such use;
[(D) diagnosing and treating alcohol use
disorders; and
[(E) referring patients, when necessary, to
other appropriate care.
[(3) Use of funds.--An entity receiving a grant under
this subsection may use such funding for the purposes
identified in paragraph (2) by--
[(A) providing training to health care
providers;
[(B) disseminating best practices, including
culturally and linguistically appropriate best
practices, as appropriate, and developing and
distributing materials; and
[(C) supporting other activities, as
determined appropriate by the Assistant
Secretary.
[(4) Application.--To be eligible to receive a grant
under this subsection, an entity shall submit an
application to the Assistant Secretary at such time,
and in such manner, and accompanied by such information
as the Assistant Secretary may require. Each
application shall include--
[(A) a description of the entity;
[(B) a description of activities to be
completed;
[(C) a description of how the services
specified in paragraphs (2) and (3) will be
carried out and the qualifications for
providing such services; and
[(D) a timeline for the completion of such
activities.
[(5) Definitions.--For the purpose of this
subsection:
[(A) Brief intervention.--The term ``brief
intervention'' means, after screening a
patient, providing the patient with brief
advice and other brief motivational enhancement
techniques designed to increase the insight of
the patient regarding the patient's alcohol
use, and any realized or potential consequences
of such use, to effect the desired related
behavioral change.
[(B) Children and adolescents.--The term
``children and adolescents'' means any person
under 21 years of age.
[(C) Eligible entity.--The term ``eligible
entity'' means an entity consisting of
pediatric health care providers and that is
qualified to support or provide the activities
identified in paragraph (2).
[(D) Pediatric health care provider.--The
term ``pediatric health care provider'' means a
provider of primary health care to individuals
under the age of 21 years.
[(E) Screening.--The term ``screening'' means
using validated patient interview techniques to
identify and assess the existence and extent of
alcohol use in a patient.]
(c) Interagency Coordinating Committee; Annual Report on
State Underage Drinking Prevention and Enforcement
Activities.--
(1) Interagency coordinating committee on the
prevention of underage drinking.--
(A) In general.--The Secretary, in
collaboration with the Federal officials
specified in subparagraph (B), shall continue
to support and enhance the efforts of the
interagency coordinating committee, that began
operating in 2004, focusing on underage
drinking (referred to in this subsection as the
``Committee'').
(B) Other agencies.--The officials referred
to in subparagraph (A) are the Secretary of
Education, the Attorney General, the Secretary
of Transportation, the Secretary of the
Treasury, the Secretary of Defense, the Surgeon
General, the Director of the Centers for
Disease Control and Prevention, the Director of
the National Institute on Alcohol Abuse and
Alcoholism, the Assistant Secretary for Mental
Health and Substance Use, the Director of the
National Institute on Drug Abuse, the Assistant
Secretary for Children and Families, the
Director of the Office of National Drug Control
Policy, the Administrator of the National
Highway Traffic Safety Administration, the
Administrator of the Office of Juvenile Justice
and Delinquency Prevention, the Chairman of the
Federal Trade Commission, and such other
Federal officials as the Secretary of Health
and Human Services determines to be
appropriate.
(C) Chair.--The Secretary of Health and Human
Services shall serve as the chair of the
Committee.
(D) Duties.--The Committee shall guide policy
and program development across the Federal
Government with respect to underage drinking,
provided, however, that nothing in this section
shall be construed as transferring regulatory
or program authority from an Agency to the
Coordinating Committee.
(E) Consultations.--The Committee shall
actively seek the input of and shall consult
with all appropriate and interested parties,
including States, public health research and
interest groups, foundations, and alcohol
beverage industry trade associations and
companies.
(F) Annual report.--
(i) In general.--The Secretary, on
behalf of the Committee, shall annually
submit to the Congress a report that
summarizes--
(I) all programs and policies
of Federal agencies designed to
prevent and reduce underage
drinking, focusing particularly
on programs and policies that
support the adoption and
enforcement of State policies
designed to prevent and reduce
underage drinking as specified
in paragraph (2);
(II) the extent of progress
in preventing and reducing
underage drinking at State and
national levels;
(III) data that the Secretary
shall collect with respect to
the information specified in
clause (ii); and
(IV) such other information
regarding underage drinking as
the Secretary determines to be
appropriate.
(ii) Certain information.--The report
under clause (i) shall include
information on the following:
(I) Patterns and consequences
of underage drinking as
reported in research and
surveys such as, but not
limited to, Monitoring the
Future, Youth Risk Behavior
Surveillance System, the
National Survey on Drug Use and
Health, and the Fatality
Analysis Reporting System.
(II) Measures of the
availability of alcohol from
commercial and non-commercial
sources to underage
populations.
(III) Measures of the
exposure of underage
populations to messages
regarding alcohol in
advertising, social media, and
the entertainment media.
(IV) Surveillance data,
including information on the
onset and prevalence of
underage drinking, consumption
patterns, beverage preferences,
prevalence of drinking among
students at institutions of
higher education, correlations
between adult and youth
drinking, and the means of
underage access, including
trends over time for these
surveillance data. The
Secretary shall develop a plan
to improve the collection,
measurement, and consistency of
reporting Federal underage
alcohol data.
(V) Any additional findings
resulting from research
conducted or supported under
subsection (f).
(VI) Evidence-based best
practices to prevent and reduce
underage drinking including a
review of the research
literature related to State
laws, regulations, and policies
designed to prevent and reduce
underage drinking, as described
in paragraph (2)(B)(i).
(2) Annual report on state underage drinking
prevention and enforcement activities.--
(A) In general.--The Secretary shall, with
input and collaboration from other appropriate
Federal agencies, States, Indian Tribes,
territories, and public health, consumer, and
alcohol beverage industry groups, annually
issue a report on each State's performance in
enacting, enforcing, and creating laws,
regulations, and policies to prevent or reduce
underage drinking based on an assessment of
best practices developed pursuant to paragraph
(1)(F)(ii)(VI) and subparagraph (B)(i). For
purposes of this paragraph, each such report,
with respect to a year, shall be referred to as
the ``State Report''. Each State Report shall
be designed as a resource tool for Federal
agencies assisting States in the their underage
drinking prevention efforts, State public
health and law enforcement agencies, State and
local policymakers, and underage drinking
prevention coalitions including those receiving
grants pursuant to subsection (e).
(B) State performance measures.--
(i) In general.--The Secretary shall
develop, in consultation with the
Committee, a set of measures to be used
in preparing the State Report on best
practices as they relate to State laws,
regulations, policies, and enforcement
practices.
(ii) State report content.--The State
Report shall include updates on State
laws, regulations, and policies
included in previous reports to
Congress, including with respect to the
following:
(I) Whether or not the State
has comprehensive anti-underage
drinking laws such as for the
illegal sale, purchase, attempt
to purchase, consumption, or
possession of alcohol; illegal
use of fraudulent ID; illegal
furnishing or obtaining of
alcohol for an individual under
21 years; the degree of
strictness of the penalties for
such offenses; and the
prevalence of the enforcement
of each of these infractions.
(II) Whether or not the State
has comprehensive liability
statutes pertaining to underage
access to alcohol such as dram
shop, social host, and house
party laws, and the prevalence
of enforcement of each of these
laws.
(III) Whether or not the
State encourages and conducts
comprehensive enforcement
efforts to prevent underage
access to alcohol at retail
outlets, such as random
compliance checks and shoulder
tap programs, and the number of
compliance checks within
alcohol retail outlets measured
against the number of total
alcohol retail outlets in each
State, and the result of such
checks.
(IV) Whether or not the State
encourages training on the
proper selling and serving of
alcohol for all sellers and
servers of alcohol as a
condition of employment.
(V) Whether or not the State
has policies and regulations
with regard to direct sales to
consumers and home delivery of
alcoholic beverages.
(VI) Whether or not the State
has programs or laws to deter
adults from purchasing alcohol
for minors; and the number of
adults targeted by these
programs.
(VII) Whether or not the
State has enacted graduated
drivers licenses and the extent
of those provisions.
(iii) Additional categories.--In
addition to the updates on State laws,
regulations, and policies listed in
clause (ii), the Secretary shall
consider the following:
(I) Whether or not States
have adopted laws, regulations,
and policies that deter
underage alcohol use, as
described in ``The Surgeon
General's Call to Action to
Prevent and Reduce Underage
Drinking'' issued in 2007 and
``Facing Addiction in America:
The Surgeon General's Report on
Alcohol, Drugs and Health''
issued in 2016, including
restrictions on low-price,
high-volume drink specials, and
wholesaler pricing provisions.
(II) Whether or not States
have adopted laws, regulations,
and policies designed to reduce
alcohol advertising messages
attractive to youth and youth
exposure to alcohol advertising
and marketing in measured and
unmeasured media and digital
and social media.
(III) Whether or not States
have laws and policies that
promote underage drinking
prevention policy development
by local jurisdictions.
(IV) Whether or not States
have adopted laws, regulations,
and policies to restrict youth
access to alcoholic beverages
that may pose special risks to
youth, including but not
limited to alcoholic mists,
gelatins, freezer pops,
premixed caffeinated alcoholic
beverages, and flavored malt
beverages.
(V) Whether or not States
have adopted uniform best
practices protocols for
conducting compliance checks
and shoulder tap programs.
(VI) Whether or not States
have adopted uniform best
practices penalty protocols for
violations of laws prohibiting
retail licensees from selling
or furnishing of alcohol to
minors.
(iv) Uniform data system.--For
performance measures related to
enforcement of underage drinking laws
as specified in clauses (ii) and (iii),
the Secretary shall develop and test a
uniform data system for reporting State
enforcement data, including the
development of a pilot program for this
purpose. The pilot program shall
include procedures for collecting
enforcement data from both State and
local law enforcement jurisdictions.
(3) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection $1,000,000 for each of fiscal years 2023
through 2027.
(d) National Media Campaign To Prevent Underage Drinking.--
(1) In general.--The Secretary, in consultation with
the National Highway Traffic Safety Administration,
shall develop an intensive, multifaceted, adult-
oriented national media campaign to reduce underage
drinking by influencing attitudes regarding underage
drinking, increasing the willingness of adults to take
actions to reduce underage drinking, and encouraging
public policy changes known to decrease underage
drinking rates.
(2) Purpose.--The purpose of the national media
campaign described in this section shall be to achieve
the following objectives:
(A) Instill a broad societal commitment to
reduce underage drinking.
(B) Increase specific actions by adults that
are meant to discourage or inhibit underage
drinking.
(C) Decrease adult conduct that tends to
facilitate or condone underage drinking.
(3) Components.--When implementing the national media
campaign described in this section, the Secretary
shall--
(A) educate the public about the public
health and safety benefits of evidence-based
policies to reduce underage drinking, including
minimum legal drinking age laws, and build
public and parental support for and cooperation
with enforcement of such policies;
(B) educate the public about the negative
consequences of underage drinking;
(C) promote specific actions by adults that
are meant to discourage or inhibit underage
drinking, including positive behavior modeling,
general parental monitoring, and consistent and
appropriate discipline;
(D) discourage adult conduct that tends to
facilitate underage drinking, including the
hosting of underage parties with alcohol and
the purchasing of alcoholic beverages on behalf
of underage youth;
(E) establish collaborative relationships
with local and national organizations and
institutions to further the goals of the
campaign and assure that the messages of the
campaign are disseminated from a variety of
sources;
(F) conduct the campaign through multi-media
sources; and
(G) conduct the campaign with regard to
changing demographics and cultural and
linguistic factors.
(4) Consultation requirement.--In developing and
implementing the national media campaign described in
this section, the Secretary shall consult
recommendations for reducing underage drinking
published by the National Academy of Sciences and the
Surgeon General. The Secretary shall also consult with
interested parties including medical, public health,
and consumer and parent groups, law enforcement,
institutions of higher education, community
organizations and coalitions, and other stakeholders
supportive of the goals of the campaign.
(5) Annual report.--The Secretary shall produce an
annual report on the progress of the development or
implementation of the media campaign described in this
subsection, including expenses and projected costs,
and, as such information is available, report on the
effectiveness of such campaign in affecting adult
attitudes toward underage drinking and adult
willingness to take actions to decrease underage
drinking.
(6) Research on youth-oriented campaign.--The
Secretary may, based on the availability of funds,
conduct research on the potential success of a youth-
oriented national media campaign to reduce underage
drinking. The Secretary shall report any such results
to Congress with policy recommendations on establishing
such a campaign.
(7) Administration.--The Secretary may enter into a
subcontract with another Federal agency to delegate the
authority for execution and administration of the
adult-oriented national media campaign.
(8) Authorization of appropriations.--There is
authorized to be appropriated to carry out this section
$2,500,000 for each of fiscal years 2023 through 2027.
(e) Community-Based Coalition Enhancement Grants To Prevent
Underage Drinking.--
(1) Authorization of program.--The Assistant
Secretary for Mental Health and Substance Use, in
consultation with the Director of the Office of
National Drug Control Policy, shall award enhancement
grants to eligible entities to design, implement,
evaluate, and disseminate comprehensive strategies to
maximize the effectiveness of community-wide approaches
to preventing and reducing underage drinking. This
subsection is subject to the availability of
appropriations.
(2) Purposes.--The purposes of this subsection are
to--
(A) prevent and reduce alcohol use among
youth in communities throughout the United
States;
(B) strengthen collaboration among
communities, the Federal Government, Tribal
Governments, and State and local governments;
(C) enhance intergovernmental cooperation and
coordination on the issue of alcohol use among
youth;
(D) serve as a catalyst for increased citizen
participation and greater collaboration among
all sectors and organizations of a community
that first demonstrates a long-term commitment
to reducing alcohol use among youth;
(E) implement state-of-the-art science-based
strategies to prevent and reduce underage
drinking by changing local conditions in
communities; and
(F) enhance, not supplant, effective local
community initiatives for preventing and
reducing alcohol use among youth.
(3) Application.--An eligible entity desiring an
enhancement grant under this subsection shall submit an
application to the Assistant Secretary at such time,
and in such manner, and accompanied by such information
and assurances, as the Assistant Secretary may require.
Each application shall include--
(A) a complete description of the entity's
current underage alcohol use prevention
initiatives and how the grant will
appropriately enhance the focus on underage
drinking issues; or
(B) a complete description of the entity's
current initiatives, and how it will use this
grant to enhance those initiatives by adding a
focus on underage drinking prevention.
(4) Uses of funds.--Each eligible entity that
receives a grant under this subsection shall use the
grant funds to carry out the activities described in
such entity's application submitted pursuant to
paragraph (3) and obtain specialized training and
technical assistance by the entity funded under section
4 of Public Law 107-82, as amended (21 U.S.C. 1521
note). Grants under this subsection shall not exceed
$60,000 per year and may not exceed four years.
(5) Supplement not supplant.--Grant funds provided
under this subsection shall be used to supplement, not
supplant, Federal and non-Federal funds available for
carrying out the activities described in this
subsection.
(6) Evaluation.--Grants under this subsection shall
be subject to the same evaluation requirements and
procedures as the evaluation requirements and
procedures imposed on recipients of drug-free community
grants.
(7) Definitions.--For purposes of this subsection,
the term ``eligible entity'' means an organization that
is currently receiving or has received grant funds
under the Drug-Free Communities Act of 1997.
(8) Administrative expenses.--Not more than 6 percent
of a grant under this subsection may be expended for
administrative expenses.
(9) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection $11,500,000 for each of fiscal years 2023
through 2027.
(f) Grants to Professional Pediatric Provider Organizations
To Reduce Underage Drinking Through Screening and Brief
Interventions.--
(1) In general.--The Secretary, acting through the
Assistant Secretary for Mental Health and Substance
Use, shall make one or more grants to professional
pediatric provider organizations to increase among the
members of such organizations effective practices to
reduce the prevalence of alcohol use among individuals
under the age of 21, including college students.
(2) Purposes.--Grants under this subsection shall be
made to promote the practices of--
(A) screening adolescents for alcohol use;
(B) offering brief interventions to
adolescents to discourage such use;
(C) educating parents about the dangers of
and methods of discouraging such use;
(D) diagnosing and treating alcohol use
disorders; and
(E) referring patients, when necessary, to
other appropriate care.
(3) Use of funds.--A professional pediatric provider
organization receiving a grant under this section may
use the grant funding to promote the practices
specified in paragraph (2) among its members by--
(A) providing training to health care
providers;
(B) disseminating best practices, including
culturally and linguistically appropriate best
practices, and developing, printing, and
distributing materials; and
(C) supporting other activities approved by
the Assistant Secretary.
(4) Application.--To be eligible to receive a grant
under this subsection, a professional pediatric
provider organization shall submit an application to
the Assistant Secretary at such time, and in such
manner, and accompanied by such information and
assurances as the Secretary may require. Each
application shall include--
(A) a description of the pediatric provider
organization;
(B) a description of the activities to be
completed that will promote the practices
specified in paragraph (2);
(C) a description of the organization's
qualifications for performing such practices;
and
(D) a timeline for the completion of such
activities.
(5) Definitions.--For the purpose of this subsection:
(A) Brief intervention.--The term ``brief
intervention'' means, after screening a
patient, providing the patient with brief
advice and other brief motivational enhancement
techniques designed to increase the insight of
the patient regarding the patient's alcohol
use, and any realized or potential consequences
of such use to effect the desired related
behavioral change.
(B) Adolescents.--The term ``adolescents''
means individuals under 21 years of age.
(C) Professional pediatric provider
organization.--The term ``professional
pediatric provider organization'' means an
organization or association that--
(i) consists of or represents
pediatric health care providers; and
(ii) is qualified to promote the
practices specified in paragraph (2).
(D) Screening.--The term ``screening'' means
using validated patient interview techniques to
identify and assess the existence and extent of
alcohol use in a patient.
(6) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection $3,000,000 for each of fiscal years 2023
through 2027.
(g) Data Collection and Research.--
(1) Additional research on underage drinking.--
(A) In general.--The Secretary shall, subject
to the availability of appropriations, collect
data, and conduct or support research that is
not duplicative of research currently being
conducted or supported by the Department of
Health and Human Services, on underage
drinking, with respect to the following:
(i) Improve data collection in
support of evaluation of the
effectiveness of comprehensive
community-based programs or strategies
and statewide systems to prevent and
reduce underage drinking, across the
underage years from early childhood to
age 21, such as programs funded and
implemented by governmental entities,
public health interest groups and
foundations, and alcohol beverage
companies and trade associations,
through the development of models of
State-level epidemiological
surveillance of underage drinking by
funding in States or large metropolitan
areas new epidemiologists focused on
excessive drinking including underage
alcohol use.
(ii) Obtain and report more precise
information than is currently collected
on the scope of the underage drinking
problem and patterns of underage
alcohol consumption, including improved
knowledge about the problem and
progress in preventing, reducing, and
treating underage drinking, as well as
information on the rate of exposure of
youth to advertising and other media
messages encouraging and discouraging
alcohol consumption.
(iii) Synthesize, expand on, and
widely disseminate existing research on
effective strategies for reducing
underage drinking, including
translational research, and make this
research easily accessible to the
general public.
(iv) Improve and conduct public
health surveillance on alcohol use and
alcohol-related conditions in States by
increasing the use of surveys, such as
the Behavioral Risk Factor Surveillance
System, to monitor binge and excessive
drinking and related harms among
individuals who are at least 18 years
of age, but not more than 20 years of
age, including harm caused to self or
others as a result of alcohol use that
is not duplicative of research
currently being conducted or supported
by the Department of Health and Human
Services.
(B) Authorization of appropriations.--There
is authorized to be appropriated to carry out
this paragraph $5,000,000 for each of fiscal
years 2023 through 2027.
(2) National academy of sciences study.--
(A) In general.--Not later than 12 months
after the enactment of the Restoring Hope for
Mental Health and Well-Being Act of 2022, the
Secretary shall--
(i) contract with the National
Academy of Sciences to study
developments in research on underage
drinking and the public policy
implications of these developments; and
(ii) report to the Congress on the
results of such review.
(B) Authorization of appropriations.--There
is authorized to be appropriated to carry out
this paragraph $500,000 for fiscal year 2023.
* * * * * * *
Subpart 3--Center for Mental Health Services
* * * * * * *
SEC. 520A. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND NATIONAL
SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority mental
health needs of regional and national significance (as
determined under subsection (b)) through the provision of or
through assistance for--
(1) knowledge development and application projects
for prevention, treatment, and rehabilitation, and the
conduct or support of evaluations of such projects;
(2) training and technical assistance programs;
(3) targeted capacity response programs; and
(4) systems change grants including statewide family
network grants and client-oriented and consumer run
self-help activities, which may include technical
assistance centers.
The Secretary may carry out the activities described in this
subsection directly or through grants, contracts, or
cooperative agreements with States, political subdivisions of
States, [Indian tribes or tribal organizations] Indian Tribes
or Tribal organizations (as such terms are defined in section 4
of the Indian Self-Determination and Education Assistance Act),
health facilities, or programs operated by or in accordance
with a contract or grant with the Indian Health Service, or,
other public or private nonprofit entities.
(b) Priority Mental Health Needs.--
(1) Determination of needs.--Priority mental health
needs of regional and national significance shall be
determined by the Secretary in consultation with States
and other interested groups. The Secretary shall meet
with the States and interested groups on an annual
basis to discuss program priorities.
(2) Special consideration.--In developing program
priorities described in paragraph (1), the Secretary
shall give special consideration to promoting the
integration of mental health services into primary
health care systems.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts, and
cooperative agreements under this section shall comply
with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for projects
carried out under subsection (a), require that entities
that apply for grants, contracts, or cooperative
agreements under this section provide non-Federal
matching funds, as determined appropriate by the
Secretary, to ensure the institutional commitment of
the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--
(1) In general.--The Secretary shall establish
information and education programs to disseminate and
apply the findings of the knowledge development and
application, training, and technical assistance
programs, and targeted capacity response programs,
under this section to the general public, to health
care professionals, and to interested groups. The
Secretary shall make every effort to provide linkages
between the findings of supported projects and State
agencies responsible for carrying out mental health
services.
(2) Rural and underserved areas.--In disseminating
information on evidence-based practices in the
provision of children's mental health services under
this subsection, the Secretary shall ensure that such
information is distributed to rural and medically
underserved areas.
(3) Geriatric mental disorders.--The Secretary shall,
as appropriate, provide technical assistance to
grantees regarding evidence-based practices for the
prevention and treatment of geriatric mental disorders
and co-occurring mental health and substance use
disorders among geriatric populations, as well as
disseminate information about such evidence-based
practices to States and nongrantees throughout the
United States.
(f) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section [$394,550,000 for
each of fiscal years 2018 through 2022] $599,036,000 for each
of fiscal years 2023 through 2027.
* * * * * * *
SEC. 520C. SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.
(a) Program Authorized.--The Secretary, acting through the
Assistant Secretary, shall establish a research, training, and
technical assistance resource center to provide appropriate
information, training, and technical assistance to States,
political subdivisions of States, federally recognized Indian
[tribes] Tribes, [tribal] Tribal organizations, institutions of
higher education, public organizations, or private nonprofit
organizations regarding the prevention of suicide among all
ages, particularly among groups that are at a high risk for
suicide.
(b) Responsibilities of the Center.--The center established
under subsection (a) shall conduct activities for the purpose
of--
(1) developing and continuing statewide or [tribal]
Tribal suicide early intervention and prevention
strategies for all ages, particularly among groups that
are at a high risk for suicide;
(2) ensuring the surveillance of suicide early
intervention and prevention strategies for all ages,
particularly among groups that are at a high risk for
suicide;
(3) studying the costs and effectiveness of statewide
and tribalsuicide early intervention and prevention
strategies in order to provide information concerning
relevant issues of importance to State, [tribal]
Tribal, and national policymakers;
(4) further identifying and understanding causes and
associated risk factors for suicide;
(5) analyzing the efficacy of new and existing
suicide early intervention and prevention techniques
and technology;
(6) ensuring the surveillance of suicidal behaviors
and nonfatal suicidal attempts;
(7) studying the effectiveness of State-sponsored
statewide and [tribal] Tribal suicide early
intervention and prevention strategies on the overall
wellness and health promotion strategies related to
suicide attempts;
(8) promoting the sharing of data regarding suicide
with Federal agencies involved with suicide early
intervention and prevention, and State-sponsored
statewide or [tribal] Tribal suicide early intervention
and prevention strategies for the purpose of
identifying previously unknown mental health causes and
associated risk factors for suicide;
(9) evaluating and disseminating outcomes and best
practices of mental health and substance use disorder
services at institutions of higher education; and
(10) conducting other activities determined
appropriate by the Secretary.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated [$5,988,000 for each of fiscal years 2018 through
2022] $9,000,000 for each of fiscal years 2023 through 2027.
(d) Annual Report.--[Not later than 2 years after the date of
enactment of this subsection] Not later than 2 years after the
date of enactment of the Restoring Hope for Mental Health and
Well-Being Act of 2022, the Secretary shall submit to Congress
a report on the activities carried out by the center
established under subsection (a) during the year involved,
including the potential effects of such activities, and the
States, organizations, and institutions that have worked with
the center.
SEC. 520E. YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
(a) In General.--The Secretary, acting through the Assistant
Secretary for Mental Health and Substance Use, shall award
grants or cooperative agreements to eligible entities to--
(1) develop and implement State-sponsored statewide
or [tribal] Tribal youth suicide early intervention and
prevention strategies in schools, educational
institutions, juvenile justice systems, substance use
disorder programs, mental health programs, foster care
systems, pediatric health programs, and other child and
youth support organizations;
(2) support public organizations and private
nonprofit organizations actively involved in State-
sponsored statewide or [tribal] Tribal youth suicide
early intervention and prevention strategies and in the
development and continuation of State-sponsored
statewide youth suicide early intervention and
prevention strategies;
(3) provide grants to institutions of higher
education to coordinate the implementation of State-
sponsored statewide or [tribal] Tribal youth suicide
early intervention and prevention strategies;
(4) collect and analyze data on State-sponsored
statewide or [tribal] Tribal youth suicide early
intervention and prevention services that can be used
to monitor the effectiveness of such services and for
research, technical assistance, and policy development;
and
(5) assist eligible entities, through State-sponsored
statewide or [tribal] Tribal youth suicide early
intervention and prevention strategies, in achieving
targets for youth suicide reductions under title V of
the Social Security Act.
(b) Eligible Entity.--
(1) Definition.--In this section, the term ``eligible
entity'' means--
(A) a State;
[(B) a public organization or private
nonprofit organization designated by a State to
develop or direct the State-sponsored statewide
youth suicide early intervention and prevention
strategy; or]
(B) a public organization or private
nonprofit organization designated by a State or
Indian Tribe (as defined under the Federally
Recognized Indian Tribe List Act of 1994) to
develop or direct the State-sponsored statewide
or Tribal youth suicide early intervention and
prevention strategy; or
(C) a Federally recognized Indian [tribe]
Tribe or [tribal] Tribal organization (as
defined in the Indian Self-Determination and
Education Assistance Act) or an urban Indian
organization (as defined in the Indian Health
Care Improvement Act) that is actively involved
in the development and continuation of a
[tribal] Tribal youth suicide early
intervention and prevention strategy.
(2) Limitation.--In carrying out this section, the
Secretary shall ensure that a State does not receive
more than 1 grant or cooperative agreement under this
section at any 1 time. For purposes of the preceding
sentence, a State shall be considered to have received
a grant or cooperative agreement if the eligible entity
involved is the State or an entity designated by the
State under paragraph (1)(B). Nothing in this paragraph
shall be construed to apply to entities described in
paragraph (1)(C).
(3) Consideration.--In awarding grants under this
section, the Secretary shall take into consideration
the extent of the need of the applicant, including the
incidence and prevalence of suicide in the State and
among the populations of focus, including rates of
suicide determined by the Centers for Disease Control
and Prevention for the State or population of focus.
(4) Consultation.--An entity described in paragraph
(1)(A) or (1)(B) that applies for a grant or
cooperative agreement under this section shall agree to
consult or confer with entities described in paragraph
(1)(C) and Native Hawaiian Health Care Systems, as
applicable, in the applicable State with respect to the
development and implementation of a statewide early
intervention strategy.
(c) Preference.--In providing assistance under a grant or
cooperative agreement under this section, an eligible entity
shall give preference to public organizations, private
nonprofit organizations, political subdivisions, institutions
of higher education, and [tribal] Tribal organizations actively
involved with the State-sponsored statewide or [tribal] Tribal
youth suicide early intervention and prevention strategy that--
(1) provide early intervention and assessment
services, including screening programs, to youth who
are at risk for mental or emotional disorders that may
lead to a suicide attempt, and that are integrated with
school systems, educational institutions, juvenile
justice systems, substance use disorder programs,
mental health programs, foster care systems, pediatric
health programs, and other child and youth support
organizations;
(2) demonstrate collaboration among early
intervention and prevention services or certify that
entities will engage in future collaboration;
(3) employ or include in their applications a
commitment to evaluate youth suicide early intervention
and prevention practices and strategies adapted to the
local community;
(4) provide timely referrals for appropriate
community-based mental health care and treatment of
youth who are at risk for suicide in child-serving
settings and agencies;
(5) provide immediate support and information
resources to families of youth who are at risk for
suicide;
(6) offer access to services and care to youth with
diverse linguistic and cultural backgrounds;
(7) offer appropriate postsuicide intervention
services, care, and information to families, friends,
schools, educational institutions, juvenile justice
systems, substance use disorder programs, mental health
programs, foster care systems, pediatric health
programs, and other child and youth support
organizations of youth who recently completed suicide;
(8) offer continuous and up-to-date information and
awareness campaigns that target parents, family
members, child care professionals, community care
providers, and the general public and highlight the
risk factors associated with youth suicide and the
life-saving help and care available from early
intervention and prevention services;
(9) ensure that information and awareness campaigns
on youth suicide risk factors, and early intervention
and prevention services, use effective communication
mechanisms that are targeted to and reach youth,
families, schools, educational institutions, pediatric
health programs, and youth organizations;
(10) provide a timely response system to ensure that
child-serving professionals and providers are properly
trained in youth suicide early intervention and
prevention strategies and that child-serving
professionals and providers involved in early
intervention and prevention services are properly
trained in effectively identifying youth who are at
risk for suicide;
(11) provide continuous training activities for child
care professionals and community care providers on the
latest youth suicide early intervention and prevention
services practices and strategies;
(12) conduct annual self-evaluations of outcomes and
activities, including consulting with interested
families and advocacy organizations;
(13) provide services in areas or regions with rates
of youth suicide that exceed the national average as
determined by the Centers for Disease Control and
Prevention; [and]
(14) obtain informed written consent from a parent or
legal guardian of an at-risk child before involving the
child in a youth suicide early intervention and
prevention program[.]; and
(15) provide to parents, legal guardians, and family
members of youth, supplies to securely store means
commonly used in suicide, if applicable, within the
household.
(d) Requirement for [Direct Services] Suicide Prevention
Activities.--Not less than 85 percent of grant funds received
under this section shall be used to provide [direct services,
of which not less than 5 percent shall be used for activities
authorized under subsection (a)(3)] suicide prevention
activities.
(e) Coordination and Collaboration.--
(1) In general.--In carrying out this section, the
Secretary shall collaborate with relevant Federal
agencies and suicide working groups responsible for
early intervention and prevention services relating to
youth suicide.
(2) Consultation.--In carrying out this section, the
Secretary shall consult with--
(A) State and local agencies, including
agencies responsible for early intervention and
prevention services under title XIX of the
Social Security Act, the State Children's
Health Insurance Program under title XXI of the
Social Security Act, and programs funded by
grants under title V of the Social Security
Act;
(B) local and national organizations that
serve youth at risk for suicide and their
families;
(C) relevant national medical and other
health and education specialty organizations;
(D) youth who are at risk for suicide, who
have survived suicide attempts, or who are
currently receiving care from early
intervention services;
(E) families and friends of youth who are at
risk for suicide, who have survived suicide
attempts, who are currently receiving care from
early intervention and prevention services, or
who have completed suicide;
(F) qualified professionals who possess the
specialized knowledge, skills, experience, and
relevant attributes needed to serve youth at
risk for suicide and their families; and
(G) third-party payers, managed care
organizations, and related commercial
industries.
(3) Policy development.--In carrying out this
section, the Secretary shall--
(A) coordinate and collaborate on policy
development at the Federal level with the
relevant Department of Health and Human
Services and Department of Education agencies
and suicide working groups; and
(B) consult on policy development at the
Federal level with the private sector,
including consumer, medical, suicide prevention
advocacy groups, and other health and education
professional-based organizations, with respect
to State-sponsored statewide or [tribal] Tribal
youth suicide early intervention and prevention
strategies.
(f) Rule of Construction; Religious and Moral
Accommodation.--Nothing in this section shall be construed to
require suicide assessment, early intervention, or treatment
services for youth whose parents or legal guardians object
based on the parents' or legal guardians' religious beliefs or
moral objections.
(g) Evaluations and Report.--
(1) Evaluations by eligible entities.--Not later than
[18] 24 months after receiving a grant or cooperative
agreement under this section, an eligible entity shall
submit to the Secretary the results of an evaluation to
be conducted by the entity concerning the effectiveness
of the activities carried out under the grant or
agreement.
(2) Report.--Not later than [2 years after the date
of enactment of Helping Families in Mental Health
Crisis Reform Act of 2016] 3 years after December 31,
2022, the Secretary shall submit to the appropriate
committees of Congress a report concerning the results
of--
(A) the evaluations conducted under paragraph
(1); and
(B) an evaluation conducted by the Secretary
to analyze the effectiveness and efficacy of
the activities conducted with grants,
collaborations, and consultations under this
section.
(h) Rule of Construction; Student Medication.--Nothing in
this section or section 520E-1 shall be construed to allow
school personnel to require that a student obtain any
medication as a condition of attending school or receiving
services.
(i) Prohibition.--Funds appropriated to carry out this
section, section 520C, section 520E-1, or section 520E-2 shall
not be used to pay for or refer for abortion.
(j) Parental consent.--States and entities receiving funding
under this section and section 520E-1 shall obtain prior
written, informed consent from the child's parent or legal
guardian for assessment services, school-sponsored programs,
and treatment involving medication related to youth suicide
conducted in elementary and secondary schools. The requirement
of the preceding sentence does not apply in the following
cases:
(1) In an emergency, where it is necessary to protect
the immediate health and safety of the student or other
students.
(2) Other instances, as defined by the State, where
parental consent cannot reasonably be obtained.
(k) Relation to Education Provisions.--Nothing in this
section or section 520E-1 shall be construed to supersede
section 444 of the General Education Provisions Act, including
the requirement of prior parental consent for the disclosure of
any education records. Nothing in this section or section 520E-
1 shall be construed to modify or affect parental notification
requirements for programs authorized under the Elementary and
Secondary Education Act of 1965 (as amended by the No Child
Left Behind Act of 2001; Public Law 107-110).
(l) Definitions.--In this section:
(1) Early intervention.--The term ``early
intervention'' means a strategy or approach that is
intended to prevent an outcome or to alter the course
of an existing condition.
(2) Educational institution; institution of higher
education; school.--The term--
(A) ``educational institution'' means a
school or institution of higher education;
(B) ``institution of higher education'' has
the meaning given such term in section 101 of
the Higher Education Act of 1965; and
(C) ``school'' means an elementary school or
secondary school (as such terms are defined in
section 8101 of the Elementary and Secondary
Education Act of 1965).
(3) Prevention.--The term ``prevention'' means a
strategy or approach that reduces the likelihood or
risk of onset, or delays the onset, of adverse health
problems that have been known to lead to suicide.
(4) Youth.--The term ``youth'' means individuals who
are [between 10 and 24 years of age] up to 24 years of
age.
(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated [$30,000,000 for each of fiscal years 2018 through
2022] $40,000,000 for each of fiscal years 2023 through 2027.
* * * * * * *
SEC. 520E-2. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES [ON
CAMPUS] FOR STUDENTS IN HIGHER EDUCATION.
(a) In General.--The Secretary, acting through the Director
of the Center for Mental Health Services and in consultation
with the Secretary of Education, may award grants on a
competitive basis to institutions of higher education to
enhance services for students with mental health or substance
use disorders that can lead to school failure, such as
depression, substance use disorders, and suicide attempts,
prevent mental and substance use disorders, reduce stigma, and
improve the identification and treatment for students at risk,
so that students will successfully complete their studies.
(b) Use of Funds.--The Secretary may not make a grant to an
institution of higher education under this section unless the
institution agrees to use the grant only for one or more of the
following:
(1) Educating students, families, faculty, and staff
to increase awareness of mental and substance use
disorders.
(2) The operation of hotlines.
(3) Preparing informational material.
(4) Providing outreach services to notify students
about available mental and substance use disorder
services.
(5) Administering voluntary mental and substance use
disorder screenings and assessments.
(6) Supporting the training of students, faculty, and
staff to respond effectively to students with mental
and substance use disorders.
(7) Creating a network infrastructure to link
institutions of higher education with health care
providers who treat mental and substance use disorders.
(8) Providing mental and substance use disorders
prevention and treatment services to students, which
may include recovery support services and programming
and early intervention, treatment, and management,
including through the use of telehealth services.
(9) Conducting research through a counseling or
health center at the institution of higher education
involved regarding improving the behavioral health of
students through clinical services, outreach,
prevention, or academic success, in a manner that is in
compliance with all applicable personal privacy laws.
(10) Supporting student groups on campus, including
athletic teams, that engage in activities to educate
students, including activities to reduce stigma
surrounding mental and behavioral disorders, and
promote mental health.
(11) Employing appropriately trained staff.
(12) Developing and supporting evidence-based and
emerging best practices, including a focus on
culturally and linguistically appropriate best
practices.
(c) Eligible grant recipients.--Any institution of higher
education receiving a grant under this section may carry out
activities under the grant through--
(1) college counseling centers;
(2) college and university psychological service
centers;
(3) mental health centers;
(4) psychology training clinics; or
(5) institution of higher education supported,
evidence-based, mental health and substance use
disorder programs.
(d) Application.--To be eligible to receive a grant under
this section, an institution of higher education shall prepare
and submit an application to the Secretary at such time and in
such manner as the Secretary may require. At a minimum, the
application shall include the following:
(1) A description of the population to be targeted by
the program carried out under the grant, including
veterans whenever possible and appropriate, and of
identified mental and substance use disorder needs of
students at the institution of higher education.
(2) A description of Federal, State, local, private,
and institutional resources currently available to
address the needs described in paragraph (1) at the
institution of higher education, which may include, as
appropriate and in accordance with subsection (b)(7), a
plan to seek input from relevant stakeholders in the
community, including appropriate public and private
entities, in order to carry out the program under the
grant.
(3) A description of the outreach strategies of the
institution of higher education for promoting access to
services, including a proposed plan for reaching those
students most in need of mental health services.
(4) A plan to evaluate program outcomes, including a
description of the proposed use of funds, the program
objectives, and how the objectives will be met.
(5) An assurance that the institution will submit a
report to the Secretary each fiscal year on the
activities carried out with the grant and the results
achieved through those activities.
(6) An outline of the objectives of the program
carried out under the grant.
(7) For an institution of higher education proposing
to use the grant for an activity described in paragraph
(8) or (9) of subsection (b), a description of the
policies and procedures of the institution of higher
education that are related to applicable laws regarding
access to, and sharing of, treatment records of
students at any campus-based mental health center or
partner organization, including the policies and State
laws governing when such records can be accessed and
shared for non-treatment purposes and a description of
the process used by the institution of higher education
to notify students of these policies and procedures,
including the extent to which written consent is
required.
(8) An assurance that grant funds will be used to
supplement and not supplant any other Federal, State,
or local funds available to carry out activities of the
type carried out under the grant.
(e) Requirement of Matching Funds.--
(1) In general.--The Secretary may make a grant under
this section to an institution of higher education only
if the institution agrees to make available (directly
or through donations from public or private entities)
non-Federal contributions in an amount that is not less
than $1 for each $1 of Federal funds provided in the
grant, toward the costs of activities carried out with
the grant (as described in subsection (b)) and other
activities by the institution to reduce student mental
health and substance use disorders.
(2) Determination of amount contributed.--Non-Federal
contributions required under paragraph (1) may be in
cash or in kind. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such non-
Federal contributions.
(3) Waiver.--The Secretary may waive the requirement
established in paragraph (1) with respect to an
institution of higher education if the Secretary
determines that extraordinary need at the institution
justifies the waiver.
(f) Reports.--For each fiscal year that grants are awarded
under this section, the Secretary shall conduct a study on the
results of the grants and submit to the Congress a report on
such results that includes the following:
(1) An evaluation of the grant program outcomes,
including a summary of activities carried out with the
grant and the results achieved through those
activities.
(2) Recommendations on how to improve access to
mental health and substance use disorder services at
institutions of higher education, including efforts to
reduce the incidence of suicide and substance use
disorders.
(g) Definition.--In this section, the term ``institution of
higher education'' has the meaning given such term in section
101 of the Higher Education Act of 1965.
(h) Technical Assistance.--The Secretary may provide
technical assistance to grantees in carrying out this section.
(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $7,000,000 for each of fiscal years [2018 through
2022] 2023 through 2027.
* * * * * * *
SEC. 520E-4. TREATMENT REFERRAL ROUTING SERVICE.
(a) In General.--The Secretary, acting through the Assistant
Secretary, shall maintain the National Treatment Referral
Routing Service (referred to in this section as the ``Routing
Service'') to assist individuals and families in locating
mental and substance use disorders treatment providers.
(b) Activities of the Secretary.--To maintain the Routing
Service, the activities of the Assistant Secretary shall
include administering--
(1) a nationwide, telephone number providing year-
round access to information that is updated on a
regular basis regarding local behavioral health
providers and community-based organizations in a manner
that is confidential, without requiring individuals to
identify themselves, is in languages that include at
least English and Spanish, and is at no cost to the
individual using the Routing Service; and
(2) an Internet website to provide a searchable,
online treatment services locator of behavioral health
treatment providers and community-based organizations,
which shall include information on the name, location,
contact information, and basic services provided by
such providers and organizations.
(c) Removing Practitioner Contact Information.--In the event
that the Internet website described in subsection (b)(2)
contains [information on any qualified practitioner that is
certified to prescribe medication for opioid dependency under
section 303(g)(2)(B) of the Controlled Substances Act]
information on any practitioner who prescribes narcotic drugs
in schedule III, IV, or V of section 202 of the Controlled
Substances Act for the purpose of maintenance or detoxification
treatment, the Assistant Secretary--
(1) shall provide an opportunity to such practitioner
to have the contact information of the practitioner
removed from the website at the request of the
practitioner; and
(2) may evaluate other methods to periodically update
the information displayed on such website.
(d) Rule of Construction.--Nothing in this section shall be
construed to prevent the Assistant Secretary from using any
unobligated amounts otherwise made available to the
Administration to maintain the Routing Service.
[SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.
[(a) In General.--The Secretary shall award competitive
grants to--
[(1) State and local governments and Indian tribes
and tribal organizations, to enhance community-based
crisis response systems; or
[(2) States to develop, maintain, or enhance a
database of beds at inpatient psychiatric facilities,
crisis stabilization units, and residential community
mental health and residential substance use disorder
treatment facilities, for adults with a serious mental
illness, children with a serious emotional disturbance,
or individuals with a substance use disorder.
[(b) Applications.--
[(1) In general.--To receive a grant under subsection
(a), an entity shall submit to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary may
require.
[(2) Community-based crisis response plan.--An
application for a grant under subsection (a)(1) shall
include a plan for--
[(A) promoting integration and coordination
between local public and private entities
engaged in crisis response, including first
responders, emergency health care providers,
primary care providers, law enforcement, court
systems, health care payers, social service
providers, and behavioral health providers;
[(B) developing memoranda of understanding
with public and private entities to implement
crisis response services;
[(C) addressing gaps in community resources
for crisis intervention and prevention; and
[(D) developing models for minimizing
hospital readmissions, including through
appropriate discharge planning.
[(3) Beds database plan.--An application for a grant
under subsection (a)(2) shall include a plan for
developing, maintaining, or enhancing a real-time,
Internet-based bed database to collect, aggregate, and
display information about beds in inpatient psychiatric
facilities and crisis stabilization units, and
residential community mental health and residential
substance use disorder treatment facilities to
facilitate the identification and designation of
facilities for the temporary treatment of individuals
in mental or substance use disorder crisis.
[(c) Database Requirements.--A bed database described in this
section is a database that--
[(1) includes information on inpatient psychiatric
facilities, crisis stabilization units, and residential
community mental health and residential substance use
disorder facilities in the State involved, including
contact information for the facility or unit;
[(2) provides real-time information about the number
of beds available at each facility or unit and, for
each available bed, the type of patient that may be
admitted, the level of security provided, and any other
information that may be necessary to allow for the
proper identification of appropriate facilities for
treatment of individuals in mental or substance use
disorder crisis; and
[(3) enables searches of the database to identify
available beds that are appropriate for the treatment
of individuals in mental or substance use disorder
crisis.
[(d) Evaluation.--An entity receiving a grant under
subsection (a)(1) shall submit to the Secretary, at such time,
in such manner, and containing such information as the
Secretary may reasonably require, a report, including an
evaluation of the effect of such grant on--
[(1) local crisis response services and measures for
individuals receiving crisis planning and early
intervention supports;
[(2) individuals reporting improved functional
outcomes; and
[(3) individuals receiving regular followup care
following a crisis.
[(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $12,500,000 for
the period of fiscal years 2018 through 2022.]
SEC. 520F. MENTAL HEALTH CRISIS RESPONSE PARTNERSHIP PILOT PROGRAM.
(a) In General.--The Secretary shall establish a pilot
program under which the Secretary will award competitive grants
to States, localities, territories, Indian Tribes, and Tribal
organizations to establish new, or enhance existing, mobile
crisis response teams that divert the response for mental
health and substance use crises from law enforcement to mobile
crisis teams, as described in subsection (b).
(b) Mobile Crisis Teams Described.--A mobile crisis team
described in this subsection is a team of individuals--
(1) that is available to respond to individuals in
crisis and provide immediate stabilization, referrals
to community-based mental health and substance use
disorder services and supports, and triage to a higher
level of care if medically necessary;
(2) which may include licensed counselors, clinical
social workers, physicians, paramedics, crisis workers,
peer support specialists, or other qualified
individuals; and
(3) which may provide support to divert behavioral
health crisis calls from the 9-1-1 system to the 9-8-8
system.
(c) Priority.--In awarding grants under this section, the
Secretary shall prioritize applications which account for the
specific needs of the communities to be served, including
children and families, veterans, rural and underserved
populations, and other groups at increased risk of death from
suicide or overdose.
(d) Report.--
(1) Initial report.--Not later than September 30,
2024, the Secretary shall submit to Congress a report
on steps taken by the entities specified in subsection
(a) as of such date of enactment to strengthen the
partnerships among mental health providers, substance
use disorder treatment providers, primary care
physicians, mental health and substance use crisis
teams, paramedics, law enforcement officers, and other
first responders.
(2) Progress reports.--Not later than one year after
the date on which the first grant is awarded to carry
out this section, and for each year thereafter, the
Secretary shall submit to Congress a report on the
grants made during the year covered by the report,
which shall include--
(A) impact data on the teams and people
served by such programs, including demographic
information of individuals served, volume, and
types of service utilization;
(B) outcomes of the number of linkages to
community-based resources, short-term crisis
receiving and stabilization facilities, and
diversion from law enforcement or hospital
emergency department settings;
(C) data consistent with the State block
grant requirements for continuous evaluation
and quality improvement, and other relevant
data as determined by the Secretary; and
(D) the Secretary's recommendations and best
practices for--
(i) States and localities providing
mobile crisis response and
stabilization services for youth and
adults; and
(ii) improvements to the program
established under this section.
(e) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section, $10,000,000 for each
of fiscal years 2023 through 2027.
SEC. 520G. GRANTS FOR JAIL DIVERSION PROGRAMS.
(a) Program Authorized.--The Secretary shall make [up to 125]
grants to States, political subdivisions of States, and Indian
[tribes and tribal organizations] Tribes and Tribal
organizations (as the terms ``Indian tribes'' and ``tribal
organizations'' are defined in section 4 of the Indian Self-
Determination and Education Assistance Act), acting directly or
through agreements with other public or nonprofit entities, or
a health facility or program operated by or in accordance with
a contract or grant with the Indian Health Service, to develop
and implement programs to divert individuals with a mental
illness from the criminal justice system to community-based
services.
(b) Administration.--
(1) Consultation.--The Secretary shall consult with
the Attorney General and any other appropriate
officials in carrying out this section.
(2) Regulatory authority.--The Secretary shall issue
regulations and guidelines necessary to carry out this
section, including methodologies and outcome measures
for evaluating programs carried out by States,
political subdivisions of States, Indian [tribes, and
tribal organizations] Tribes, and Tribal organizations
receiving grants under subsection (a).
(c) Applications.--
(1) In general.--To receive a grant under subsection
(a), the chief executive of a State, chief executive of
a subdivision of a State, Indian [tribe or tribal
organization] Tribe or Tribal organization, health
facility or program described in subsection (a), or
public or nonprofit entity referred to in subsection
(a) shall prepare and submit an application to the
Secretary at such time, in such manner, and containing
such information as the Secretary shall reasonably
require.
(2) Content.--Such application shall--
(A) contain an assurance that--
(i) community-based mental health
services will be available for the
individuals who are diverted from the
criminal justice system, and that such
services are based on evidence-based
practices, reflect current research
findings, include case management,
assertive community treatment,
medication management and access,
integrated mental health and co-
occurring substance use disorder
treatment, and psychiatric
rehabilitation, and will be coordinated
with social services, including life
skills training, housing placement,
vocational training, education job
placement, and health care;
(ii) there has been relevant
interagency collaboration between the
appropriate criminal justice, mental
health, and substance use disorder
systems; and
(iii) the Federal support provided
will be used to supplement, and not
supplant, State, local, Indian [tribe,
or tribal organization] Tribe, or
Tribal organization sources of funding
that would otherwise be available;
(B) demonstrate that the diversion program
will be integrated with an existing system of
care for those with mental illness;
(C) explain the applicant's inability to fund
the program adequately without Federal
assistance;
(D) specify plans for obtaining necessary
support and continuing the proposed program
following the conclusion of Federal support;
and
(E) describe methodology and outcome measures
that will be used in evaluating the program.
(d) Special Consideration Regarding Veterans.--In awarding
grants under subsection (a), the Secretary shall, as
appropriate, give special consideration to entities proposing
to use grant funding to support jail diversion services for
veterans.
(e) Use of Funds.--A State, political subdivision of a State,
Indian [tribe, or tribal organization] Tribe, or Tribal
organization that receives a grant under subsection (a) may use
funds received under such grant to--
(1) integrate the diversion program into the existing
system of care;
(2) create or expand community-based mental health
and co-occurring mental illness and substance use
disorder services to accommodate the diversion program;
(3) train professionals involved in the system of
care, and law enforcement officers, attorneys, and
judges;
(4) provide community outreach and crisis
intervention; and
(5) develop programs to divert individuals prior to
booking [or arrest], arrest, or release.
(f) Federal Share.--
(1) In general.--The Secretary shall pay to a State,
political subdivision of a State, Indian [tribe, or
tribal organization] Tribe, or Tribal organization
receiving a grant under subsection (a) the Federal
share of the cost of activities described in the
application.
(2) Federal share.--The Federal share of a grant made
under this section shall not exceed 75 percent of the
total cost of the program carried out by the State,
political subdivision of a State, Indian [tribe, or
tribal organization] Tribe, or Tribal organization.
Such share shall be used for new expenses of the
program carried out by such State, political
subdivision of a State, Indian [tribe, or tribal
organization] Tribe, or Tribal organization.
(3) Non-federal share.--The non-Federal share of
payments made under this section may be made in cash or
in kind fairly evaluated, including planned equipment
or services. The Secretary may waive the requirement of
matching contributions.
(g) Geographic Distribution.--The Secretary shall ensure that
such grants awarded under subsection (a) are equitably
distributed among the geographical regions of the United States
and between urban and rural populations.
(h) Training and Technical Assistance.--Training and
technical assistance may be provided by the Secretary to assist
a State, political subdivision of a State, Indian [tribe, or
tribal organization] Tribe, or Tribal organization receiving a
grant under subsection (a) in establishing and operating a
diversion program.
(i) Evaluations.--The programs described in subsection (a)
shall be evaluated not less than one time in every 12-month
period using the methodology and outcome measures identified in
the grant application.
(j) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section [$4,269,000 for each
of fiscal years 2018 through 2022] $14,000,000 for each of
fiscal years 2023 through 2027.
SEC. 520H. PEER-SUPPORTED MENTAL HEALTH SERVICES.
(a) Grants Authorized.--The Secretary, acting through the
Director of the Center for Mental Health Services, shall award
grants to eligible entities to enable such entities to develop,
expand, and enhance access to mental health peer-delivered
services.
(b) Use of Funds.--Grants awarded under subsection (a) shall
be used to develop, expand, and enhance national, statewide, or
community-focused programs, including virtual peer-support
services and infrastructure, including by--
(1) carrying out workforce development, recruitment,
and retention activities, to train, recruit, and retain
peer-support providers;
(2) building connections between mental health
treatment programs, including between community
organizations and peer-support networks, including
virtual peer-support networks, and with other mental
health support services;
(3) reducing stigma associated with mental health
disorders;
(4) expanding and improving virtual peer mental
health support services, including adoption of
technologies to expand access to virtual peer mental
health support services, including by acquiring--
(A) appropriate physical hardware for such
virtual services;
(B) software and programs to efficiently run
peer-support services virtually; and
(C) other technology for establishing virtual
waiting rooms and virtual video platforms for
meetings; and
(5) conducting research on issues relating to mental
illness and the impact peer-support has on resiliency,
including identifying--
(A) the signs of mental illness;
(B) the resources available to individuals
with mental illness and to their families; and
(C) the resources available to help support
individuals living with mental illness.
(c) Special Consideration.--In carrying out this section, the
Secretary shall give special consideration to the unique needs
of rural areas.
(d) Definition.--In this section, the term ``eligible
entity'' means--
(1) a nonprofit consumer-run organization that--
(A) is principally governed by people living
with a mental health condition; and
(B) mobilizes resources within and outside of
the mental health community, which may include
through peer-support networks, to increase the
prevalence and quality of long-term wellness of
individuals living with a mental health
condition, including those with a co-occurring
substance use disorder; or
(2) a Federally recognized Tribe, Tribal
organization, Urban Indian organization, or consortium
of Tribes or Tribal organizations.
(e) Authorization of Appropriations.--There is authorized to
be appropriated to carry out this section $13,000,000 for each
of fiscal years 2023 through 2027.
* * * * * * *
SEC. 520J. MENTAL HEALTH AWARENESS TRAINING GRANTS.
(a) In General.--The Secretary shall award grants in
accordance with the provisions of this section.
(b) Mental Health Awareness Training Grants.--
(1) In general.--The Secretary shall award grants to
States, political subdivisions of States, [Indian
tribes, tribal organizations] Indian Tribes, Tribal
organizations, and nonprofit private entities to train
teachers and other relevant school personnel to
recognize symptoms of childhood and adolescent mental
disorders, to refer family members to the appropriate
mental health services if necessary, to train emergency
services personnel veterans, law enforcement, and other
categories of individuals, as determined by the
Secretary, to identify and appropriately respond to
persons with a mental illness, and to provide education
to such teachers and personnel regarding resources that
are available in the community for individuals with a
mental illness.
(2) [Emergency Services Personnel] Emergency
services personnel.--In this subsection, the term
``emergency services personnel'' includes paramedics,
firefighters, and emergency medical technicians.
(3) [Distribution of Awards] Distribution of
awards.--The Secretary shall ensure that such grants
awarded under this subsection are equitably distributed
among the geographical regions of the United States and
between urban and rural populations.
(4) Application.--A State, political subdivision of a
State, [Indian tribe, tribal organization] Indian
Tribe, Tribal organization, or nonprofit private entity
that desires a grant under this subsection shall submit
an application to the Secretary at such time, in such
manner, and containing such information as the
Secretary may require, including a plan for the
rigorous evaluation of activities that are carried out
with funds received under a grant under this
subsection.
(5) Use of Funds.--A State, political subdivision of
a State, [Indian tribe, tribal organization] Indian
Tribe, Tribal organization, or nonprofit private entity
receiving a grant under this subsection shall use funds
from such grant for evidence-based programs that
provide training and education in accordance with
paragraph (1) on matters including--
(A) recognizing the signs and symptoms of
mental illness; [and]
(B)(i) resources available in the community
for individuals with a mental illness and other
relevant resources; or
(ii) safely de-escalating crisis situations
involving individuals with a mental illness[.];
and
(C) suicide intervention and prevention,
including recognizing warning signs and how to
refer someone for help.
(6) Evaluation.--A State, political subdivision of a
State, [Indian tribe, tribal organization] Indian
Tribe, Tribal organization, or nonprofit private entity
that receives a grant under this subsection shall
prepare and submit an evaluation to the Secretary at
such time, in such manner, and containing such
information as the Secretary may reasonably require,
including an evaluation of activities carried out with
funds received under the grant under this subsection
and a process and outcome evaluation.
(7) Authorization of Appropriations.--There is
authorized to be appropriated to carry out this
subsection [$14,693,000 for each of fiscal years 2018
through 2022] $24,963,000 for each of fiscal years 2023
through 2027.
[SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE AGREEMENTS.
[(a) Definitions.--In this section:
[(1) Eligible entity.--The term ``eligible entity''
means a State, or other appropriate State agency, in
collaboration with 1 or more qualified community
programs as described in section 1913(b)(1) or 1 or
more community health centers as described in section
330.
[(2) Integrated care.--The term ``integrated care''
means collaborative models or practices offering mental
and physical health services, which may include
practices that share the same space in the same
facility.
[(3) Special population.--The term ``special
population'' means--
[(A) adults with a mental illness who have
co-occurring physical health conditions or
chronic diseases;
[(B) adults with a serious mental illness who
have co-occurring physical health conditions or
chronic diseases;
[(C) children and adolescents with a serious
emotional disturbance with co-occurring
physical health conditions or chronic diseases;
or
[(D) individuals with a substance use
disorder.
[(b) Grants and Cooperative Agreements.--
[(1) In general.--The Secretary may award grants and
cooperative agreements to eligible entities to support
the improvement of integrated care for primary care and
behavioral health care in accordance with paragraph
(2).
[(2) Purposes.--A grant or cooperative agreement
awarded under this section shall be designed to--
[(A) promote full integration and
collaboration in clinical practices between
primary and behavioral health care;
[(B) support the improvement of integrated
care models for primary care and behavioral
health care to improve the overall wellness and
physical health status of adults with a serious
mental illness or children with a serious
emotional disturbance; and
[(C) promote integrated care services related
to screening, diagnosis, prevention, and
treatment of mental and substance use
disorders, and co-occurring physical health
conditions and chronic diseases.
[(c) Applications.--
[(1) In general.--An eligible entity seeking a grant
or cooperative agreement under this section shall
submit an application to the Secretary at such time, in
such manner, and accompanied by such information as the
Secretary may require, including the contents described
in paragraph (2).
[(2) Contents.--The contents described in this
paragraph are--
[(A) a description of a plan to achieve fully
collaborative agreements to provide services to
special populations;
[(B) a document that summarizes the policies,
if any, that serve as barriers to the provision
of integrated care, and the specific steps, if
applicable, that will be taken to address such
barriers;
[(C) a description of partnerships or other
arrangements with local health care providers
to provide services to special populations;
[(D) an agreement and plan to report to the
Secretary performance measures necessary to
evaluate patient outcomes and facilitate
evaluations across participating projects; and
[(E) a plan for sustainability beyond the
grant or cooperative agreement period under
subsection (e).
[(d) Grant and Cooperative Agreement Amounts.--
[(1) Target amount.--The target amount that an
eligible entity may receive for a year through a grant
or cooperative agreement under this section shall be
$2,000,000.
[(2) Adjustment permitted.--The Secretary, taking
into consideration the quality of the application and
the number of eligible entities that received grants
under this section prior to the date of enactment of
the Helping Families in Mental Health Crisis Reform Act
of 2016, may adjust the target amount that an eligible
entity may receive for a year through a grant or
cooperative agreement under this section.
[(3) Limitation.--An eligible entity receiving
funding under this section may not allocate more than
10 percent of funds awarded under this section to
administrative functions, and the remaining amounts
shall be allocated to health facilities that provide
integrated care.
[(e) Duration.--A grant or cooperative agreement under this
section shall be for a period not to exceed 5 years.
[(f) Report on Program Outcomes.--An eligible entity
receiving a grant or cooperative agreement under this section
shall submit an annual report to the Secretary that includes--
[(1) the progress made to reduce barriers to
integrated care as described in the entity's
application under subsection (c); and
[(2) a description of functional outcomes of special
populations, including--
[(A) with respect to adults with a serious
mental illness, participation in supportive
housing or independent living programs,
attendance in social and rehabilitative
programs, participation in job training
opportunities, satisfactory performance in work
settings, attendance at scheduled medical and
mental health appointments, and compliance with
prescribed medication regimes;
[(B) with respect to individuals with co-
occurring mental illness and physical health
conditions and chronic diseases, attendance at
scheduled medical and mental health
appointments, compliance with prescribed
medication regimes, and participation in
learning opportunities related to improved
health and lifestyle practices; and
[(C) with respect to children and adolescents
with a serious emotional disturbance who have
co-occurring physical health conditions and
chronic diseases, attendance at scheduled
medical and mental health appointments,
compliance with prescribed medication regimes,
and participation in learning opportunities at
school and extracurricular activities.
[(g) Technical Assistance for Primary-behavioral Health Care
Integration.--
[(1) In general.--The Secretary may provide
appropriate information, training, and technical
assistance to eligible entities that receive a grant or
cooperative agreement under this section, in order to
help such entities meet the requirements of this
section, including assistance with--
[(A) development and selection of integrated
care models;
[(B) dissemination of evidence-based
interventions in integrated care;
[(C) establishment of organizational
practices to support operational and
administrative success; and
[(D) other activities, as the Secretary
determines appropriate.
[(2) Additional dissemination of technical
information.--The information and resources provided by
the Secretary under paragraph (1) shall, as
appropriate, be made available to States, political
subdivisions of States, Indian tribes or tribal
organizations (as defined in section 4 of the Indian
Self-Determination and Education Assistance Act),
outpatient mental health and addiction treatment
centers, community mental health centers that meet the
criteria under section 1913(c), certified community
behavioral health clinics described in section 223 of
the Protecting Access to Medicare Act of 2014, primary
care organizations such as Federally qualified health
centers or rural health clinics as defined in section
1861(aa) of the Social Security Act, other community-
based organizations, or other entities engaging in
integrated care activities, as the Secretary determines
appropriate.
[(h) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $51,878,000
for each of fiscal years 2018 through 2022.]
SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE AGREEMENTS.
(a) Definitions.--In this section:
(1) Collaborative care model.--The term
``collaborative care model'' means the evidence-based,
integrated behavioral health service delivery method
that includes--
(A) care directed by the primary care team;
(B) structured care management;
(C) regular assessments of clinical status
using developmentally appropriate, validated
tools; and
(D) modification of treatment as appropriate.
(2) Eligible entity.--The term ``eligible entity''
means a State, or an appropriate State agency, in
collaboration with--
(A) 1 or more qualified community programs as
described in section 1913(b)(1);
(B) 1 or more health centers (as defined in
section 330(a)), a rural health clinic (as
defined in section 1961(aa) of the Social
Security Act), or a Federally qualified health
center (as defined in such section); or
(C) 1 or more primary health care practices.
(3) Integrated care; bidirectional integrated care.--
(A) The term ``integrated care'' means models
or practices for coordinating and jointly
delivering behavioral and physical health
services, which may include practices that
share the same space in the same facility.
(B) The term ``bidirectional integrated
care'' means the integration of behavioral
health care and specialty physical health care,
as well as the integration of primary and
physical health care with specialty behavioral
health settings, including within primary
health care settings.
(4) Primary health care provider.--The term ``primary
health care provider'' means a provider who--
(A) provides health services related to
family medicine, internal medicine, pediatrics,
obstetrics, gynecology, or geriatrics; or
(B) is a doctor of medicine or osteopathy,
physician assistant, or nurse practitioner, who
is licensed to practice medicine by the State
in which such physician, assistant, or
practitioner primarily practices, including
within primary health care settings.
(5) Primary health care practice.--The term ``primary
health care practice'' means a medical practice of
primary health care providers, including a practice
within a larger health care system.
(6) Special population.--The term ``special
population'', for an eligible entity that is
collaborating with an entity described in subparagraph
(A) or (B) of paragraph (3), means--
(A) adults with a serious mental illness who
have a co-occurring physical health condition
or chronic disease;
(B) children and adolescents with a mental
illness who have a co-occurring physical health
condition or chronic disease;
(C) individuals with a substance use
disorder; or
(D) individuals with a mental illness who
have a co-occurring substance use disorder.
(b) Grants and Cooperative Agreements.--
(1) In general.--The Secretary may award grants and
cooperative agreements to eligible entities to support
the improvement of integrated care for physical and
behavioral health care in accordance with paragraph
(2).
(2) Use of funds.--A grant or cooperative agreement
awarded under this section shall be used--
(A) in the case of an eligible entity that is
collaborating with an entity described in
subparagraph (A) or (B) of subsection (a)(2)--
(i) to promote full integration and
collaboration in clinical practices
between physical and behavioral health
care for special populations including
each population listed in subsection
(a)(7);
(ii) to support the improvement of
integrated care models for physical and
behavioral health care to improve the
overall wellness and physical health
status of--
(I) adults with a serious
mental illness or children with
a serious emotional
disturbance; and
(II) individuals with a
substance use disorder; and
(iii) to promote bidirectional
integrated care services including
screening, diagnosis, prevention,
treatment, and recovery of mental and
substance use disorders, and co-
occurring physical health conditions
and chronic diseases; and
(B) in the case of an eligible entity that is
collaborating with a primary health care
practice, to support the uptake of the
collaborative care model, including by--
(i) hiring staff;
(ii) identifying and formalizing
contractual relationships with other
health care providers, including
providers who will function as
psychiatric consultants and behavioral
health care managers in providing
behavioral health integration services
through the collaborative care model;
(iii) purchasing or upgrading
software and other resources needed to
appropriately provide behavioral health
integration services through the
collaborative care model, including
resources needed to establish a patient
registry and implement measurement-
based care; and
(iv) for such other purposes as the
Secretary determines to be necessary.
(c) Applications.--
(1) In general.--An eligible entity that is
collaborating with an entity described in subparagraph
(A) or (B) of subsection (a)(2) seeking a grant or
cooperative agreement under subsection (b)(2)(A) shall
submit an application to the Secretary at such time, in
such manner, and accompanied by such information as the
Secretary may require, including the contents described
in paragraph (2).
(2) Contents.--Any such application of an eligible
entity described in subparagraph (A) or (B) of
subsection (a)(2) shall include--
(A) a description of a plan to achieve fully
collaborative agreements to provide
bidirectional integrated care to special
populations;
(B) a document that summarizes the policies,
if any, that are barriers to the provision of
integrated care, and the specific steps, if
applicable, that will be taken to address such
barriers;
(C) a description of partnerships or other
arrangements with local health care providers
to provide services to special populations;
(D) an agreement and plan to report to the
Secretary performance measures necessary to
evaluate patient outcomes and facilitate
evaluations across participating projects;
(E) a description of how validated rating
scales will be implemented to support the
improvement of patient outcomes using
measurement-based care, including those related
to depression screening, patient follow-up, and
symptom remission; and
(F) a plan for sustainability beyond the
grant or cooperative agreement period under
subsection (e).
(3) Collaborative care model grants.--An eligible
entity that is collaborating with a primary health care
practice seeking a grant pursuant to subsection
(b)(2)(B) shall submit an application to the Secretary
at such time, in such manner, and accompanied by such
information as the Secretary may require.
(d) Grant and Cooperative Agreement Amounts.--
(1) Target amount.--The target amount that an
eligible entity may receive for a year through a grant
or cooperative agreement under this section shall be--
(A) $2,000,000 for an eligible entity
described in subparagraph (A) or (B) of
subsection (a)(2); or
(B) $100,000 or less for an eligible entity
described in subparagraph (C) of subsection
(a)(2).
(2) Adjustment permitted.--The Secretary, taking into
consideration the quality of an eligible entity's
application and the number of eligible entities that
received grants under this section prior to the date of
enactment of the Restoring Hope for Mental Health and
Well-Being Act of 2022, may adjust the target amount
that an eligible entity may receive for a year through
a grant or cooperative agreement under this section.
(3) Limitation.--An eligible entity that is
collaborating with an entity described in subparagraph
(A) or (B) of subsection (a)(2) receiving funding under
this section--
(A) may not allocate more than 20 percent of
the funds awarded to such eligible entity under
this section to administrative functions; and
(B) shall allocate the remainder of such
funding to health facilities that provide
integrated care.
(e) Duration.--A grant or cooperative agreement under this
section shall be for a period not to exceed 5 years.
(f) Report on Program Outcomes.--An eligible entity receiving
a grant or cooperative agreement under this section--
(1) that is collaborating with an entity described in
subparagraph (A) or (B) of subsection (a)(2) shall
submit an annual report to the Secretary that
includes--
(A) the progress made to reduce barriers to
integrated care as described in the entity's
application under subsection (c); and
(B) a description of outcomes with respect to
each special population listed in subsection
(a)(7), including outcomes related to
education, employment, and housing; or
(2) that is collaborating with a primary health care
practice shall submit an annual report to the Secretary
that includes--
(A) the progress made to improve access;
(B) the progress made to improve patient
outcomes; and
(C) the progress made to reduce referrals to
specialty care.
(g) Technical Assistance for Primary-behavioral Health Care
Integration.--
(1) Certain recipients.--The Secretary may provide
appropriate information, training, and technical
assistance to eligible entities that are collaborating
with an entity described in subparagraph (A) or (B) of
subsection (a)(2) that receive a grant or cooperative
agreement under this section, in order to help such
entities meet the requirements of this section,
including assistance with--
(A) development and selection of integrated
care models;
(B) dissemination of evidence-based
interventions in integrated care;
(C) establishment of organizational practices
to support operational and administrative
success; and
(D) other activities, as the Secretary
determines appropriate.
(2) Collaborative care model recipients.--The
Secretary shall provide appropriate information,
training, and technical assistance to eligible entities
that are collaborating with primary health care
practices that receive funds under this section to help
such entities implement the collaborative care model,
including--
(A) developing financial models and budgets
for implementing and maintaining a
collaborative care model, based on practice
size;
(B) developing staffing models for essential
staff roles;
(C) providing strategic advice to assist
practices seeking to utilize other clinicians
for additional psychotherapeutic interventions;
(D) providing information technology
expertise to assist with building the
collaborative care model into electronic health
records, including assistance with care manager
tools, patient registry, ongoing patient
monitoring, and patient records;
(E) training support for all key staff and
operational consultation to develop practice
workflows;
(F) establishing methods to ensure the
sharing of best practices and operational
knowledge among primary health care physicians
and primary health care practices that provide
behavioral health integration services through
the collaborative care model; and
(G) providing guidance and instruction to
primary health care physicians and primary
health care practices on developing and
maintaining relationships with community-based
mental health and substance use disorder
facilities for referral and treatment of
patients whose clinical presentation or
diagnosis is best suited for treatment at such
facilities.
(3) Additional dissemination of technical
information.--In addition to providing the assistance
described in paragraphs (1) and (2) to recipients of a
grant or cooperative agreement under this section, the
Secretary may also provide such assistance to other
States and political subdivisions of States, Indian
Tribes and Tribal organizations (as defined under the
Federally Recognized Indian Tribe List Act of 1994),
outpatient mental health and addiction treatment
centers, community mental health centers that meet the
criteria under section 1913(c), certified community
behavioral health clinics described in section 223 of
the Protecting Access to Medicare Act of 2014, primary
care organizations such as Federally qualified health
centers or rural health clinics as defined in section
1861(aa) of the Social Security Act, primary health
care practices, other community-based organizations,
and other entities engaging in integrated care
activities, as the Secretary determines appropriate.
(h) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $60,000,000 for
each of fiscal years 2023 through 2027.
SEC. 520L. ADULT SUICIDE PREVENTION.
(a) Grants.--
(1) In general.--The Assistant Secretary shall award
grants to eligible entities described in paragraph (2)
to implement suicide prevention and intervention
programs, for individuals who are 25 years of age or
older, that are designed to raise awareness of suicide,
establish referral processes, and improve care and
outcomes for such individuals who are at risk of
suicide.
(2) Eligible entities.--To be eligible to receive a
grant under this section, an entity shall be a
community-based primary care or behavioral health care
setting, an emergency department, a State mental health
agency (or State health agency with mental or
behavioral health functions), public health agency, a
territory of the United States, or an [Indian tribe]
Indian Tribe or [tribal organization] Tribal
organization (as the terms ``[Indian tribe] Indian
Tribe'' and ``[tribal organization] Tribal
organization'' are defined in section 4 of the Indian
Self-Determination and Education Assistance Act).
(3) Use of funds.--The grants awarded under paragraph
(1) shall be used to implement programs, in accordance
with such paragraph, that include one or more of the
following components:
(A) Screening for suicide risk, suicide
intervention services, and services for
referral for treatment for individuals at risk
for suicide.
(B) Implementing evidence-based practices to
provide treatment for individuals at risk for
suicide, including appropriate followup
services.
[(C) Raising awareness and reducing stigma of
suicide.]
(C) Raising awareness of suicide prevention
resources, promoting help seeking among those
at risk for suicide.
(b) Evaluations and Technical Assistance.--The Assistant
Secretary shall--
(1) evaluate the activities supported by grants
awarded under subsection (a), and disseminate, as
appropriate, the findings from the evaluation; and
(2) provide appropriate information, training, and
technical assistance, as appropriate, to eligible
entities that receive a grant under this section, in
order to help such entities to meet the requirements of
this section, including assistance with selection and
implementation of evidence-based interventions and
frameworks to prevent suicide.
(c) Duration.--A grant under this section shall be for a
period of not more than 5 years.
(d) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section [$30,000,000 for the
period of fiscal years 2018 through 2022] $30,000,000 for each
of fiscal years 2023 through 2027.
SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
(a) In General.--The Assistant Secretary shall award grants
to eligible entities--
(1) to establish assertive community treatment
programs for adults with a serious mental illness; or
(2) to maintain or expand such programs.
(b) Eligible Entities.--To be eligible to receive a grant
under this section, an entity shall be a State, political
subdivision of a State, [Indian tribe or tribal organization]
Indian Tribe or Tribal organization (as such terms are defined
in section 4 of the Indian Self-Determination and Education
Assistance Act), mental health system, health care facility, or
any other entity the Assistant Secretary deems appropriate.
(c) Special Consideration.--In selecting among applicants for
a grant under this section, the Assistant Secretary may give
special consideration to the potential of the applicant's
program to reduce hospitalization, homelessness, and
involvement with the criminal justice system while improving
the health and social outcomes of the patient.
(d) Additional Activities.--The Assistant Secretary shall--
(1) [not later than the end of fiscal year 2021] not
later than the end of fiscal year 2026, submit a report
to the appropriate congressional committees on the
grant program under this section, including an
evaluation of--
(A) any cost savings and public health
outcomes such as mortality, suicide, substance
use disorders, hospitalization, and use of
services;
(B) rates of involvement with the criminal
justice system of patients;
(C) rates of homelessness among patients; and
(D) patient and family satisfaction with
program participation; and
(2) provide appropriate information, training, and
technical assistance to grant recipients under this
section to help such recipients to establish, maintain,
or expand their assertive community treatment programs.
(e) Authorization of Appropriations.--
(1) In general.--To carry out this section, there is
authorized to be appropriated [$5,000,000 for the
period of fiscal years 2018 through 2022] $9,000,000
for each of fiscal years 2023 through 2027.
(2) Use of certain funds.--Of the funds appropriated
to carry out this section in any fiscal year, not more
than 5 percent shall be available to the Assistant
Secretary for carrying out subsection (d).
SEC. 520N. CRISIS RESPONSE CONTINUUM OF CARE.
(a) In General.--The Secretary shall publish best practices
for a crisis response continuum of care for use by health care
providers, crisis services administrators, and crisis services
providers in responding to individuals (including children and
adolescents) experiencing mental health crises, substance-
related crises, and crises arising from co-occurring disorders.
(b) Best Practices.--
(1) Scope of best practices.--The best practices
published under subsection (a) shall define--
(A) a minimum set of core crisis response
services, as determined by the Secretary, for
each entity that furnishes such services,
that--
(i) do not require prior
authorization from an insurance
provider or group health plan nor a
referral from a health care provider
prior to the delivery of services;
(ii) provide for serving all
individuals regardless of age or
ability to pay;
(iii) provide for operating 24 hours
a day, 7 days a week; and
(iv) provide for care and support
through resources described in
paragraph (2)(A) until the individual
has been stabilized or transferred to
the next level of crisis care; and
(B) psychiatric stabilization, including the
point at which a case may be closed for--
(i) individuals screened over the
phone; and
(ii) individuals stabilized on the
scene by mobile teams.
(2) Identification of essential functions.--The best
practices published under subsection (a) shall identify
the essential functions of each service in the crisis
response continuum, which shall include at least the
following:
(A) Identification of resources for referral
and enrollment in continuing mental health,
substance use, or other human services relevant
for the individual in crisis where necessary.
(B) Delineation of access and entry points to
services within the crisis response continuum.
(C) Development of protocols and agreements
for the transfer and receipt of individuals to
and from other segments of the crisis response
continuum segments as needed, and from outside
referrals including health care providers,
first responders including law enforcement,
paramedics, and firefighters, education
institutions, and community-based
organizations.
(D) Description of the qualifications of
crisis services staff, including roles for
physicians, licensed clinicians, case managers,
and peers (in accordance with State licensing
requirements or requirements applicable to
Tribal health professionals).
(E) The convening of collaborative meetings
of crisis response service providers, first
responders including law enforcement,
paramedics, and firefighters, and community
partners (including National Suicide Prevention
Lifeline or 9-8-8 call centers, 9-1-1 public
service answering points, and local mental
health and substance use disorder treatment
providers) operating in a common region for the
discussion of case management, best practices,
and general performance improvement.
(3) Service capacity and quality best practices.--The
best practices under subsection (a) shall include
recommendations on--
(A) adequate volume of services to meet
population need;
(B) appropriate timely response; and
(C) capacity to meet the needs of different
patient populations that may experience a
mental health or substance use crisis,
including children, families, and all age
groups, cultural and linguistic minorities,
individuals with co-occurring mental health and
substance use disorders, individuals with
cognitive disabilities, individuals with
developmental delays, and individuals with
chronic medical conditions and physical
disabilities.
(4) Implementation timeframe.--The Secretary shall--
(A) not later than 1 year after the date of
enactment of this section, publish and maintain
the best practices required by subsection (a);
and
(B) every two years thereafter, publish
updates.
(5) Data collection and evaluations.--The Secretary,
directly or through grants, contracts, or interagency
agreements, shall collect data and conduct evaluations
with respect to the provision of services and programs
offered on the crisis response continuum for purposes
of assessing the extent to which the provision of such
services and programs meet certain objectives and
outcomes measures as determined by the Secretary. Such
objectives shall include--
(A) a reduction in reliance on law
enforcement response, as appropriate, to
individuals in crisis who would be more
appropriately served by a mobile crisis team
capable of responding to mental health and
substance-related crises;
(B) a reduction in boarding or extended
holding of patients in emergency room
facilities who require further psychiatric
care, including care for substance use
disorders;
(C) evidence of adequate access to crisis
care centers and crisis bed services; and
(D) evidence of adequate linkage to
appropriate post-crisis care and longitudinal
treatment for mental health or substance use
disorder when relevant.
SEC. 520O. CENTER OF EXCELLENCE FOR EATING DISORDERS FOR EDUCATION AND
TRAINING ON EATING DISORDERS.
(a) In General.--The Secretary, acting through the Assistant
Secretary, shall maintain, by competitive grant or contract, a
Center of Excellence for Eating Disorders (referred to in this
section as the ``Center'') to improve the identification of,
interventions for, and treatment of eating disorders in a
manner that is developmentally, culturally, and linguistically
appropriate.
(b) Subgrants and Subcontracts.--The Center shall coordinate
and implement the activities under subsection (c), in whole or
in part, by awarding competitive subgrants or subcontracts--
(1) across geographical regions; and
(2) in a manner that is not duplicative.
(c) Activities.--The Center--
(1) shall--
(A) provide training and technical assistance
for--
(i) primary care and behavioral
health care providers to carry out
screening, brief intervention, and
referral to treatment for individuals
experiencing, or at risk for, eating
disorders; and
(ii) nonclinical community support
workers to identify and support
individuals with, or at
disproportionate risk for, eating
disorders;
(B) develop and provide training materials to
health care providers, including primary care
and behavioral health care providers, in the
effective treatment and ongoing support of
individuals with eating disorders, including
children and marginalized populations at
disproportionate risk for eating disorders;
(C) provide collaboration and coordination to
other centers of excellence, technical
assistance centers, and psychiatric
consultation lines of the Substance Abuse and
Mental Health Services Administration and the
Health Resources and Services Administration on
the identification, effective treatment, and
ongoing support of individuals with eating
disorders; and
(D) coordinate with the Director of the
Centers for Disease Control and Prevention and
the Administrator of the Health Resources and
Services Administration to disseminate training
to primary care and behavioral health care
providers; and
(2) may--
(A) coordinate with electronic health record
systems for the integration of protocols
pertaining to screening, brief intervention,
and referral to treatment for individuals
experiencing, or at risk for, eating disorders;
(B) develop and provide training materials to
health care providers, including primary care
and behavioral health care providers, in the
effective treatment and ongoing support for
members of the Armed Forces and veterans
experiencing, or at risk for, eating disorders;
and
(C) consult with the Secretary of Defense and
the Secretary of Veterans Affairs on
prevention, identification, intervention for,
and treatment of eating disorders.
(d) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $1,000,000 for
each of fiscal years 2023 through 2027.
* * * * * * *
Part C--Projects for Assistance in Transition From Homelessness
SEC. 521. FORMULA GRANTS TO STATES.
For the purpose of carrying out section 522, the Secretary,
acting through the Director of the Center for Mental Health
Services, shall for each of the fiscal years [2018 through
2022] 2023 through 2027 make an allotment for each State in an
amount determined in accordance with section 524. The Secretary
shall make payments, as grants, each such fiscal year to each
State from the allotment for the State if the Secretary
approves for the fiscal year involved an application submitted
by the State pursuant to section 529.
* * * * * * *
SEC. 535. FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this part, there is authorized to be appropriated
$64,635,000 for each of fiscal years [2018 through 2022] 2023
through 2027.
(b) Effect of Insufficient Appropriations for Minimum
Allotments.--
(1) In general.--If the amounts made available under
subsection (a) for a fiscal year are insufficient for
providing each State with an allotment under section
521 of not less than the applicable amount under
section 524(a)(1), the Secretary shall, from such
amounts as are made available under such subsection,
make grants to the States for providing to eligible
homeless individuals the services specified in section
522(b).
(2) Rule of construction.--Paragraph (1) may not be
construed to require the Secretary to make a grant
under such paragraph to each State.
Part D--Miscellaneous Provisions Relating to Substance Abuse and Mental
Health
* * * * * * *
SEC. 544. GRANTS FOR REDUCING OVERDOSE DEATHS.
(a) Establishment.--
(1) In general.--The Secretary shall award grants to
eligible entities to expand access to drugs or devices
[approved or cleared] approved, cleared, or otherwise
authorized under the Federal Food, Drug, and Cosmetic
Act for emergency treatment of known or suspected
opioid overdose.
[(2) Maximum grant amount.--A grant awarded under
this section may not be for more than $200,000 per
grant year.
[(3) Eligible entity.--For purposes of this section,
the term ``eligible entity'' means a Federally
qualified health center (as defined in section 1861(aa)
of the Social Security Act), an opioid treatment
program under part 8 of title 42, Code of Federal
Regulations, any practitioner dispensing narcotic drugs
pursuant to section 303(g) of the Controlled Substances
Act, or any other entity that the Secretary deems
appropriate.]
(2) Eligible entity.--For purposes of this section,
the term ``eligible entity'' means a State, Territory,
locality, Indian Tribe (as defined in the Federally
Recognized Indian Tribe List Act of 1994), Tribal
organization, or Urban Indian organization (as those
terms are defined in section 4 of the Indian Health
Care Improvement Act).
(3) Subgrants.--For the purposes for which a grant is
awarded under this section, the eligible entity
receiving the grant may award subgrants to a Federally
qualified health center (as defined in section 1861(aa)
of the Social Security Act), an opioid treatment
program (as defined in section 8.2 of title 42, Code of
Federal Regulations (or any successor regulations)),
any practitioner dispensing narcotic drugs for the
purpose of maintenance or detoxification treatment, or
any nonprofit organization that the Secretary deems
appropriate.
(4) Prescribing.--For purposes of this section, the
term ``prescribing'' means, with respect to a drug or
device [approved or cleared] approved, cleared, or
otherwise authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose, the practice of prescribing
such drug or device--
(A) in conjunction with an opioid
prescription for patients at an elevated risk
of overdose, including patients prescribed with
both an opioid and a benzodiazepine;
(B) in conjunction with an opioid agonist
approved under section 505 of the Federal Food,
Drug, and Cosmetic Act for the treatment of
opioid use disorder;
(C) to the caregiver or a close relative of
patients at an elevated risk of overdose from
opioids; or
(D) in other circumstances in which a
provider identifies a patient is at an elevated
risk for an intentional or unintentional [drug
overdose] substance overdose from heroin or
prescription opioid therapies.
(b) Application.--To be eligible to receive a grant under
this section, an eligible entity shall submit to the Secretary,
in such form and manner as specified by the Secretary, an
application that describes--
(1) the extent to which the area to which the entity
will furnish services through use of the grant is
experiencing significant morbidity and mortality caused
by opioid abuse;
(2) the criteria that will be used to identify
eligible patients to participate in such program; and
(3) a plan for sustaining the program after Federal
support for the program has ended.
(c) Use of Funds.--An eligible entity receiving a grant under
this section may use amounts under the grant for any of the
following activities, but may use not more than 20 percent of
the grant funds for activities described in paragraphs (3) and
(4):
(1) To establish a program for prescribing a drug or
device [approved or cleared] approved, cleared, or
otherwise authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose.
(2) To train and provide resources for health care
providers and pharmacists on the prescribing of drugs
or devices [approved or cleared] approved, cleared, or
otherwise authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose.
(3) To purchase drugs or devices [approved or
cleared] approved, cleared, or otherwise authorized
under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid
overdose, for distribution under the program described
in paragraph (1).
(4) To offset the co-payments and other cost sharing
associated with drugs or devices [approved or cleared]
approved, cleared, or otherwise authorized under the
Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose.
[(5) To establish protocols to connect patients who
have experienced a drug overdose with appropriate
treatment, including medication-assisted treatment and
appropriate counseling and behavioral therapies.]
(5) To establish protocols to connect patients who
have experienced an overdose with appropriate
treatment, including overdose reversal medications,
medication assisted treatment, and appropriate
counseling and behavioral therapies.
(d) Improving Access to Overdose Treatment.--
(1) Information on best practices.--
(A) Health and human services.--The Secretary
of Health and Human Services may provide
information to States, localities, Indian
Tribes, Tribal organizations, and Urban Indian
organizations on best practices for prescribing
or co-prescribing a drug or device approved,
cleared, or otherwise authorized under the
Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected
opioid overdose, including for patients
receiving chronic opioid therapy and patients
being treated for opioid use disorders.
(B) Defense.--The Secretary of Defense may
provide information to prescribers within
Department of Defense medical facilities on
best practices for prescribing or co-
prescribing a drug or device approved, cleared,
or otherwise authorized under the Federal Food,
Drug, and Cosmetic Act for emergency treatment
of known or suspected opioid overdose,
including for patients receiving chronic opioid
therapy and patients being treated for opioid
use disorders.
(C) Veterans affairs.--The Secretary of
Veterans Affairs may provide information to
prescribers within Department of Veterans
Affairs medical facilities on best practices
for prescribing or co-prescribing a drug or
device approved, cleared, or otherwise
authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known
or suspected opioid overdose, including for
patients receiving chronic opioid therapy and
patients being treated for opioid use
disorders.
(2) Rule of construction.--Nothing in this subsection
shall be construed as establishing or contributing to a
medical standard of care.
[(d)] (e) Evaluations by Recipients.--As a condition of
receipt of a grant under this section, an eligible entity
shall, for each year for which the grant is received, submit to
the Secretary an evaluation of activities funded by the grant
which contains such information as the Secretary may reasonably
require.
[(e)] (f) Reports by the Secretary.--Not later than 5 years
after the date on which the first grant under this section is
awarded, the Secretary shall submit to the appropriate
committees of the House of Representatives and of the Senate a
report aggregating the information received from the grant
recipients for such year under [subsection (d)] subsection (e)
and evaluating the outcomes achieved by the programs funded by
grants awarded under this section.
[(f)] (g) Authorization of Appropriations.--There is
authorized to be appropriated to carry out this section,
$5,000,000 for the period of [fiscal years 2017 through 2021]
fiscal years 2023 through 2027.
SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION [ACCESS AND EDUCATION
GRANT PROGRAMS] ACCESS, EDUCATION, AND CO-
PRESCRIBING GRANT PROGRAMS.
(a) [Grants to States] Grants.--The Secretary [shall make
grants to States] shall make grants to States, localities,
Indian Tribes (as defined by the Federally Recognized Indian
Tribe List Act of 1994), Tribal organizations, and Urban Indian
organizations (as those terms are defined in section 4 of the
Indian Health Care Improvement Act) to--
(1) [implement strategies for pharmacists to dispense
a drug or device] implement strategies that increase
access to drugs or devices [approved or cleared]
approved, cleared, or otherwise authorized under the
Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose, as
appropriate, pursuant to a standing order;
(2) encourage pharmacies to dispense opioid overdose
reversal medication pursuant to a standing order;
[(3)] (4) develop or provide training materials that
persons authorized to prescribe or dispense a drug or
device [approved or cleared] approved, cleared, or
otherwise authorized under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose may use to educate the public
concerning--
(A) when and how to safely administer such
drug or device; and
(B) steps to be taken after administering
such drug or device; and
[(4)] (5) educate the public concerning the
availability of drugs or devices [approved or cleared]
approved, cleared, or otherwise authorized under the
Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose without
a person-specific prescription.
(b) Certain Requirement.--A grant may be made under this
section only if the State involved has authorized standing
orders to be issued for drugs or devices [approved or cleared]
approved, cleared, or otherwise authorized under the Federal
Food, Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose.
(c) Preference in Making Grants.--In making grants under this
section, the Secretary may give preference to States that have
a significantly higher rate of opioid overdoses than the
national average, and that--
(1) have not implemented standing orders regarding
drugs or devices [approved or cleared] approved,
cleared, or otherwise authorized under the Federal
Food, Drug, and Cosmetic Act for emergency treatment of
known or suspected opioid overdose;
(2) authorize standing orders to be issued that
permit community-based organizations, substance abuse
programs, or other nonprofit entities to acquire,
dispense, or administer drugs or devices [approved or
cleared] approved, cleared, or otherwise authorized
under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid
overdose; or
[(3)] (4) authorize standing orders to be issued that
permit police, fire, or emergency medical services
agencies to acquire and administer drugs or devices
[approved or cleared] approved, cleared, or otherwise
authorized under the Federal Food, Drug, and Cosmetic
Act for emergency treatment of known or suspected
opioid overdose.
(d) Grant Terms.--
(1) Number.--A State may not receive more than one
grant under this section at a time.
(2) Period.--A grant under this section shall be for
a period of [3 years] 5 years.
[[(3)] (4) Limitation.--A State may use not more than
20 percent of a grant under this section for educating
the public pursuant to subsection (a)(4).]
(3) Limitations.--A State may--
(A) use not more than 10 percent of a grant
under this section for educating the public
pursuant to subsection (a)(5); and
(B) use not less than 20 percent of a grant
under this section to offset cost-sharing for
distribution and dispensing of drugs or devices
approved, cleared, or otherwise authorized
under the Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or suspected
opioid overdose.
(e) Applications.--To be eligible to receive a grant under
this section, a State shall submit an application to the
Secretary in such form and manner and containing such
information as the Secretary may reasonably require, including
detailed proposed expenditures of grant funds.
(f) Reporting.--A State that receives a grant under this
section shall, at least annually for the duration of the grant,
submit a report to the Secretary evaluating the progress of the
activities supported through the grant. Such reports shall
include information on the number of pharmacies in the State
that dispense a drug or device [approved or cleared] approved,
cleared, or otherwise authorized under the Federal Food, Drug,
and Cosmetic Act for emergency treatment of known or suspected
opioid overdose under a standing order, and other information
as the Secretary determines appropriate to evaluate the use of
grant funds.
(g) Definitions.--In this section the term ``standing order''
means a document prepared by a person authorized to prescribe
medication that permits another person to acquire, dispense, or
administer medication without a person-specific prescription.
(h) Authorization of Appropriations.--
(1) In general.--To carry out this section, there are
authorized to be appropriated $5,000,000 for the period
of [fiscal years 2017 through 2019] fiscal years 2023
through 2027.
(2) Administrative costs.--Not more than 3 percent of
the amounts made available to carry out this section
may be used by the Secretary for administrative
expenses of carrying out this section.
* * * * * * *
SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE OPIOID [ABUSE]
USE DISORDER RESPONSE.
(a) Definitions.--In this section:
(1) Dispenser.--The term ``dispenser'' has the
meaning given the term in section 102 of the Controlled
Substances Act (21 U.S.C. 802).
(2) Prescriber.--The term ``prescriber'' means a
dispenser who prescribes a controlled substance, or the
agent of such a dispenser.
(3) Prescriber of a schedule ii, iii, or iv
controlled substance.--The term ``prescriber of a
schedule II, III, or IV controlled substance'' does not
include a prescriber of a schedule II, III, or IV
controlled substance that dispenses the substance--
(A) for use on the premises on which the
substance is dispensed;
(B) in a hospital emergency room, when the
substance is in short supply;
(C) for a certified opioid treatment program;
or
(D) in other situations as the Secretary may
reasonably determine.
(4) Schedule ii, iii, or iv controlled substance.--
The term ``schedule II, III, or IV controlled
substance'' means a controlled substance that is listed
on schedule II, schedule III, or schedule IV of section
202(c) of the Controlled Substances Act.
(b) Grants for Comprehensive Opioid [Abuse] Use Disorder
Response.--
(1) In general.--The Secretary shall award grants to
States, and combinations of States, to implement an
integrated opioid [abuse] use disorder response
initiative.
(2) Purposes.--A State receiving a grant under this
section shall establish a comprehensive response plan
to opioid [abuse] use disorder, which may include--
(A) education efforts around [opioid use,
treatment, and addiction recovery] opioid use
disorders, and treatment for, and recovery from
opioid use disorders, including education of
residents, medical students, and physicians and
other prescribers of schedule II, III, or IV
controlled substances on relevant prescribing
guidelines, the prescription drug monitoring
program of the State described in subparagraph
(B), and overdose prevention methods;
(B) establishing, maintaining, or improving a
comprehensive prescription drug monitoring
program to track dispensing of schedule II,
III, or IV controlled substances, which may--
(i) provide for data sharing with
other States; and
(ii) allow all individuals authorized
by the State to write prescriptions for
schedule II, III, or IV controlled
substances to access the prescription
drug monitoring program of the State;
(C) developing, implementing, or expanding
prescription drug and opioid [addiction] use
disorder treatment programs by--
(i) expanding the availability of
treatment for prescription drug and
opioid [addiction] use disorder,
including medication-assisted treatment
and behavioral health therapy, as
appropriate;
(ii) developing, implementing, or
expanding screening for individuals in
treatment for prescription drug and
opioid [addiction] use disorder for
hepatitis C and HIV, and treating or
referring those individuals if
clinically appropriate; or
(iii) developing, implementing, or
expanding recovery support services and
programs at high schools or
institutions of higher education;
[(D) developing, implementing, and expanding
efforts to prevent overdose death from opioid
abuse or addiction to prescription medications
and opioids; and]
(D) developing, implementing, and expanding
efforts to prevent overdose death from opioid
or other prescription medication use disorders;
and
(E) advancing the education and awareness of
the public, providers, patients, consumers, and
other appropriate entities regarding the
dangers of opioid [abuse] use disorders, safe
disposal of prescription medications, and
detection of early warning signs of opioid use
disorders.
(3) Application.--A State seeking a grant under this
section shall submit to the Secretary an application in
such form, and containing such information, as the
Secretary may reasonably require.
(4) Use of funds.--A State that receives a grant
under this section shall use the grant for the cost,
including the cost for technical assistance, training,
and administration expenses, of carrying out an
integrated opioid [abuse] use disorders response
initiative as outlined by the State's comprehensive
response plan to opioid [abuse] use disorders
established under paragraph (2).
(5) Priority considerations.--In awarding grants
under this section, the Secretary shall, as
appropriate, give priority to a State that--
(A)(i) provides civil liability protection
for first responders, health professionals, and
family members who have received appropriate
training in administering a drug or device
approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment
of known or suspected opioid overdose; and
(ii) submits to the Secretary a certification
by the attorney general of the State that the
attorney general has--
(I) reviewed any applicable civil
liability protection law to determine
the applicability of the law with
respect to first responders, health
care professionals, family members, and
other individuals who--
(aa) have received
appropriate training in
administering a drug or device
approved or cleared under the
Federal Food, Drug, and
Cosmetic Act for emergency
treatment of known or suspected
opioid overdose; and
(bb) may administer a drug or
device approved or cleared
under the Federal Food, Drug,
and Cosmetic Act for emergency
treatment of known or suspected
opioid overdose; and
(II) concluded that the law described
in subclause (I) provides adequate
civil liability protection applicable
to such persons;
(B) has a process for enrollment in services
and benefits necessary by criminal justice
agencies to initiate or continue treatment in
the community, under which an individual who is
incarcerated may, while incarcerated, enroll in
services and benefits that are necessary for
the individual to continue treatment upon
release from incarceration;
(C) ensures the capability of data sharing
with other States, where applicable, such as by
making data available to a prescription
monitoring hub;
(D) ensures that data recorded in the
prescription drug monitoring program database
of the State are regularly updated, to the
extent possible;
(E) ensures that the prescription drug
monitoring program of the State notifies
prescribers and dispensers of schedule II, III,
or IV controlled substances when overuse or
misuse of such controlled substances by
patients is suspected; and
(F) has in effect one or more statutes or
implements policies that maximize use of
prescription drug monitoring programs by
individuals authorized by the State to
prescribe schedule II, III, or IV controlled
substances.
(6) Evaluation.--In conducting an evaluation of the
program under this section pursuant to section 701 of
the Comprehensive Addiction and Recovery Act of 2016,
with respect to a State, the Secretary shall report on
State legislation or policies related to maximizing the
use of prescription drug monitoring programs and the
incidence of opioid use disorders and overdose deaths
in such State.
(7) States with local prescription drug monitoring
programs.--
(A) In general.--In the case of a State that
does not have a prescription drug monitoring
program, a county or other unit of local
government within the State that has a
prescription drug monitoring program shall be
treated as a State for purposes of this
section, including for purposes of eligibility
for grants under paragraph (1).
(B) Plan for interoperability.--In submitting
an application to the Secretary under paragraph
(3), a county or other unit of local government
shall submit a plan outlining the methods such
county or unit of local government shall use to
ensure the capability of data sharing with
other counties and units of local government
within the state and with other States, as
applicable.
(c) Authorization of Funding.--For the purpose of carrying
out this section, there are authorized to be appropriated
$5,000,000 for each of fiscal years [2017 through 2021] 2023
through 2027.
SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION [ON
COLLEGE CAMPUSES] AT INSTITUTIONS OF HIGHER
EDUCATION.
(a) Purpose.--It is the purpose of this section to increase
access to, and reduce the stigma associated with, mental health
services to ensure that students at institutions of higher
education have the support necessary to successfully complete
their studies.
(b) National Public Education Campaign.--The Secretary,
acting through the Assistant Secretary and in collaboration
with the Director of the Centers for Disease Control and
Prevention, shall convene an interagency, public-private sector
working group to plan, establish, and begin coordinating and
evaluating a targeted public education campaign that is
designed to focus on mental and behavioral health on the
campuses of institutions of higher education. Such campaign
shall be designed to--
(1) improve the general understanding of mental
health and mental disorders;
(2) encourage help-seeking behaviors relating to the
promotion of mental health, prevention of mental
disorders, and treatment of such disorders;
(3) make the connection between mental and behavioral
health and academic success; and
(4) assist the general public in identifying the
early warning signs and reducing the stigma of mental
illness.
(c) Composition.--The working group convened under subsection
(b) shall include--
(1) mental health consumers, including students and
family members;
(2) representatives of institutions of higher
education, including minority-serving institutions as
described in section 371(a) of the Higher Education Act
of 1965 (20 U.S.C. 1067q) and community colleges;
(3) representatives of national mental and behavioral
health associations and associations of institutions of
higher education;
(4) representatives of health promotion and
prevention organizations at institutions of higher
education;
(5) representatives of mental health providers,
including community mental health centers; and
(6) representatives of private-sector and public-
sector groups with experience in the development of
effective public health education campaigns.
(d) Plan.--The working group under subsection (b) shall
develop a plan that--
(1) targets promotional and educational efforts to
the age population of students at institutions of
higher education and individuals who are employed in
settings of institutions of higher education, including
through the use of roundtables;
(2) develops and proposes the implementation of
research-based public health messages and activities;
(3) provides support for local efforts to reduce
stigma by using the National Health Information Center
as a primary point of contact for information,
publications, and service program referrals; and
(4) develops and proposes the implementation of a
social marketing campaign that is targeted at the
population of students attending institutions of higher
education and individuals who are employed in settings
of institutions of higher education.
(e) Definition.--In this section, the term ``institution of
higher education'' has the meaning given such term in section
101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $1,000,000 for
the period of fiscal years [2018 through 2022] 2023 through
2027.
SEC. [550.] 550A. NATIONAL RECOVERY HOUSING BEST PRACTICES.
(a) Best Practices for Operating Recovery Housing.--
[(1) In general.--The Secretary, in consultation with
the individuals and entities specified in paragraph
(2), shall identify or facilitate the development of
best practices, which may include model laws for
implementing suggested minimum standards, for operating
recovery housing.]
(1) In general.--The Secretary, in consultation with
the individuals and entities specified in paragraph
(2), shall build on existing best practices and
previously developed guidelines to develop and
periodically update consensus-based best practices,
which may include model laws for implementing suggested
minimum standards for operating, and promoting the
availability of, high-quality recovery housing.
(2) Consultation.--In carrying out the activities
described in paragraph (1), the Secretary shall consult
with, as appropriate--
[(A) relevant divisions of the Department of
Health and Human Services, including the
Substance Abuse and Mental Health Services
Administration, the Office of Inspector
General, the Indian Health Service, and the
Centers for Medicare & Medicaid Services;
[(B) the Secretary of Housing and Urban
Development;]
(A) Officials representing the agencies
described in subsection (e)(2).
[(C)] (B) directors or commissioners, as
applicable, of State health departments, tribal
health departments, State Medicaid programs,
and State insurance agencies;
[(D)] (C) representatives of health insurance
issuers;
[(E)] (D) national accrediting entities and
reputable providers of, and analysts of,
recovery housing services, including Indian
tribes, tribal organizations, and tribally
designated housing entities that provide
recovery housing services, as applicable;
[(F)] (E) individuals with a history of
substance use disorder; and
[(G)] (F) other stakeholders identified by
the Secretary.
(3) Availability.--The best practices referred to in
paragraph (1) shall be--
(A) made publicly available; and
(B) published on the public website of the
Substance Abuse and Mental Health Services
Administration.
(4) Exclusion of guideline on treatment services.--In
developing the guidelines under paragraph (1), the
Secretary may not include any guidelines with respect
to substance use disorder treatment services.
(b) Identification of Fraudulent Recovery Housing
Operators.--
(1) In general.--The Secretary, in consultation with
the individuals and entities described in paragraph
(2), shall identify or facilitate the development of
common indicators that could be used to identify
potentially fraudulent recovery housing operators.
(2) Consultation.--In carrying out the activities
described in paragraph (1), the Secretary shall consult
with, as appropriate, the individuals and entities
specified in subsection (a)(2) and the Attorney General
of the United States.
(3) Requirements.--
(A) Practices for identification and
reporting.--In carrying out the activities
described in paragraph (1), the Secretary shall
consider how law enforcement, public and
private payers, and the public can best
identify and report fraudulent recovery housing
operators.
(B) Factors to be considered.--In carrying
out the activities described in paragraph (1),
the Secretary shall identify or develop
indicators, which may include indicators
related to--
(i) unusual billing practices;
(ii) average lengths of stays;
(iii) excessive levels of drug
testing (in terms of cost or
frequency); and
(iv) unusually high levels of
recidivism.
(c) Dissemination.--The Secretary shall, as appropriate,
disseminate the best practices identified or developed under
subsection (a) and the common indicators identified or
developed under subsection (b) to--
(1) State agencies, which may include the provision
of technical assistance to State agencies seeking to
adopt or implement such best practices;
(2) Indian tribes, tribal organizations, and tribally
designated housing entities;
(3) the Attorney General of the United States;
(4) the Secretary of Labor;
(5) the Secretary of Housing and Urban Development;
(6) State and local law enforcement agencies;
(7) health insurance issuers;
(8) recovery housing entities; and
(9) the public.
(d) Requirements.--In carrying out the activities described
in subsections (a) and (b), the Secretary, in consultation with
appropriate individuals and entities described in subsections
(a)(2) and (b)(2), shall consider how recovery housing is able
to support recovery and prevent relapse, recidivism, or
overdose (including overdose death), including by improving
access and adherence to treatment, including medication-
assisted treatment.
[(e)] (g) Rule of Construction.--Nothing in this section
shall be construed to provide the Secretary with the authority
to require States to adhere to minimum standards in the State
oversight of recovery housing.
[(f)] (h) Definitions.--In this section:
(1) The term ``recovery housing'' means a shared
living environment free from alcohol and illicit drug
use and centered on peer support and connection to
services that promote sustained recovery from substance
use disorders.
(2) The terms ``Indian tribe'' and ``tribal
organization'' have the meanings given those terms in
section 4 of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 5304).
(3) The term ``tribally designated housing entity''
has the meaning given that term in section 4 of the
Native American Housing Assistance and Self-
Determination Act of 1996 (25 U.S.C. 4103).
[(g)] (i) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $3,000,000 for
the period of fiscal years 2019 through 2021.
* * * * * * *
Part E--Children With Serious Emotional Disturbances
* * * * * * *
SEC. 565. GENERAL PROVISIONS.
(a) Duration of Support.--The period during which payments
are made to a public entity from a grant under section 561(a)
may not exceed 6 fiscal years.
(b) Technical Assistance.--
(1) In general.--The Secretary shall, upon the
request of a public entity, regardless of whether such
public entity is receiving a grant under section
561(a)--
(A) provide technical assistance to the
entity regarding the process of submitting to
the Secretary applications for grants under
section 561(a); and
(B) provide to the entity training and
technical assistance with respect to the
planning, development, and operation of systems
of care described in section 562.
(2) Authority for grants and contracts.--The
Secretary may provide technical assistance under
subsection (a) directly or through grants to, or
contracts with, public and nonprofit private entities.
(c) Evaluations and Reports by Secretary.--
(1) In general.--The Secretary shall, directly or
through contracts with public or private entities,
provide for annual evaluations of programs carried out
pursuant to section 561(a). The evaluations shall
assess the effectiveness of the systems of care
operated pursuant to such section, including
longitudinal studies of outcomes of services provided
by such systems, other studies regarding such outcomes,
the effect of activities under this part on the
utilization of hospital and other institutional
settings, the barriers to and achievements resulting
from interagency collaboration in providing community-
based services to children with a serious emotional
disturbance, and assessments by parents of the
effectiveness of the systems of care.
(2) Report to congress.--The Secretary shall, not
later than 1 year after the date on which amounts are
first appropriated under subsection (c), and annually
thereafter, submit to the Congress a report summarizing
evaluations carried out pursuant to paragraph (1)
during the preceding fiscal year and making such
recommendations for administrative and legislative
initiatives with respect to this section as the
Secretary determines to be appropriate.
(d) Definitions.--For purposes of this part:
(1) The term ``child'' means an individual through
the age of 21 years.
(2) The term ``family'', with respect to a child
provided access to a system of care under section
562(a), means--
(A) the legal guardian of the child; and
(B) [as appropriate regarding mental health
services for the child, the parents of the
child (biological or adoptive, as the case may
be) and any foster parents of the child] as
appropriate regarding mental health services
for the child and the parents or kinship
caregivers of the child.
(3) The term ``funding agreement'', with respect to a
grant under section 561(a) to a public entity, means
that the Secretary may make such a grant only if the
public entity makes the agreement involved.
(4) The term ``serious emotional disturbance''
includes, with respect to a child, any child who has a
serious emotional disorder, a serious behavioral
disorder, or a serious mental disorder.
(e) Rule of Construction.--Nothing in this part shall be
construed as limiting the rights of a child with a serious
emotional disturbance under the Individuals with Disabilities
Education Act.
(f) Funding.--
(1) Authorization of appropriations.--For the purpose of
carrying out this part, there are authorized to be appropriated
[$119,026,000 for each of fiscal years 2018 through 2022]
$125,000,000 for each of fiscal years 2023 through 2027.
(2) Limitation regarding technical assistance.--Not more than
10 percent of the amounts appropriated under paragraph (1) for
a fiscal year may be expended for carrying out subsection (b).
* * * * * * *
PART K--MINORITY FELLOWSHIP PROGRAM
SEC. 597. FELLOWSHIPS.
(a) In General.--The Secretary shall maintain a program, to
be known as the Minority Fellowship Program, under which the
Secretary shall award fellowships, which may include stipends,
for the purposes of--
(1) increasing the knowledge of mental and substance
use disorders practitioners on issues related to
prevention, treatment, and recovery support for
individuals who are from racial and ethnic minority
populations and who have a mental or substance use
disorder;
(2) improving the quality of mental and substance use
disorder prevention and treatment services delivered to
racial and ethnic minority populations; and
(3) increasing the number of culturally competent
mental and substance use disorders professionals who
teach, administer services, conduct research, and
provide direct mental or substance use disorder
services to racial and ethnic minority populations.
(b) Training Covered.--The fellowships awarded under
subsection (a) shall be for postbaccalaureate training
(including for master's and doctoral degrees) for mental and
substance use disorder treatment professionals, including [in
the fields of psychiatry,] in the fields of crisis care
management, psychiatry, nursing, social work, psychology,
marriage and family therapy, mental health counseling, and
substance use disorder and addiction counseling.
(c) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $12,669,000
for each of fiscal years 2018 through 2022.
SEC. [550.] 550A. SOBRIETY TREATMENT AND RECOVERY TEAMS.
(a) In General.--The Secretary may make grants to States,
units of local government, or tribal governments to establish
or expand Sobriety Treatment And Recovery Team (referred to in
this section as ``START'') or other similar programs to
determine the effectiveness of pairing social workers or
mentors with families that are struggling with a substance use
disorder and child abuse or neglect in order to help provide
peer support, intensive treatment, and child welfare services
to such families.
(b) Allowable Uses.--A grant awarded under this section may
be used for one or more of the following activities:
(1) Training eligible staff, including social
workers, social services coordinators, child welfare
specialists, substance use disorder treatment
professionals, and mentors.
(2) Expanding access to substance use disorder
treatment services and drug testing.
(3) Enhancing data sharing with law enforcement
agencies, child welfare agencies, substance use
disorder treatment providers, judges, and court
personnel.
(4) Program evaluation and technical assistance.
(c) Program Requirements.--A State, unit of local government,
or tribal government receiving a grant under this section
shall--
(1) serve only families for which--
(A) there is an open record with the child
welfare agency; and
(B) substance use disorder was a reason for
the record or finding described in paragraph
(1); and
(2) coordinate any grants awarded under this section
with any grant awarded under section 437(f) of the
Social Security Act focused on improving outcomes for
children affected by substance abuse.
(d) Technical Assistance.--The Secretary may reserve not more
than 5 percent of funds provided under this section to provide
technical assistance on the establishment or expansion of
programs funded under this section from the National Center on
Substance Abuse and Child Welfare.
(e) Coordination of Federal Activities to Promote the
Availability of Housing for Individuals Experiencing
Homelessness, Individuals With a Mental Illness, and
Individuals With a Substance Use Disorder.--
(1) In general.--The Secretary, acting through the
Assistant Secretary, and the Secretary of Housing and
Urban Development shall convene an interagency working
group for the following purposes:
(A) To increase collaboration, cooperation,
and consultation among the Department of Health
and Human Services, the Department of Housing
and Urban Development, and the Federal agencies
listed in paragraph (2)(B), with respect to
promoting the availability of housing,
including recovery housing, for individuals
experiencing homelessness, individuals with
mental illnesses, and individuals with
substance use disorder.
(B) To align the efforts of such agencies and
avoid duplication of such efforts by such
agencies.
(C) To develop objectives, priorities, and a
long-term plan for supporting State, Tribal,
and local efforts with respect to the operation
of recovery housing that is consistent with the
best practices developed under this section.
(D) To coordinate enforcement of fair housing
practices, as appropriate, among Federal and
State agencies.
(E) To coordinate data collection on the
quality of recovery housing.
(2) Composition.--The interagency working group under
paragraph (1) shall be composed of--
(A) the Secretary, acting through the
Assistant Secretary, and the Secretary of
Housing and Urban Development, who shall serve
as the co-chairs; and
(B) representatives of each of the following
Federal agencies:
(i) The Centers for Medicare &
Medicaid Services.
(ii) The Substance Abuse and Mental
Health Services Administration.
(iii) The Health Resources and
Services Administration.
(iv) The Office of Inspector General.
(v) The Indian Health Service.
(vi) The Department of Agriculture.
(vii) The Department of Justice.
(viii) The Office of National Drug
Control Policy.
(ix) The Bureau of Indian Affairs.
(x) The Department of Labor.
(xi) The Department of Veterans
Affairs.
(xii) Any other Federal agency as the
co-chairs determine appropriate.
(3) Meetings.--The working group shall meet on a
quarterly basis.
(4) Reports to congress.--Not later than 4 years
after the date of the enactment of this section, the
working group shall submit to the Committee on Energy
and Commerce, the Committee on Ways and Means, the
Committee on Agriculture, and the Committee on
Financial Services of the House of Representatives and
the Committee on Health, Education, Labor, and
Pensions, the Committee on Agriculture, Nutrition, and
Forestry, and the Committee on Finance of the Senate a
report describing the work of the working group and any
recommendations of the working group to improve
Federal, State, and local coordination with respect to
recovery housing and other housing resources and
operations for individuals experiencing homelessness,
individuals with a mental illness, and individuals with
a substance use disorder.
(f) Grants for Implementing National Recovery Housing Best
Practices.--
(1) In general.--The Secretary shall award grants to
States (and political subdivisions thereof), Tribes,
and territories--
(A) for the provision of technical assistance
to implement the guidelines and recommendations
developed under subsection (a); and
(B) to promote--
(i) the availability of recovery
housing for individuals with a
substance use disorder; and
(ii) the maintenance of recovery
housing in accordance with best
practices developed under this section.
(2) State promotion plans.--Not later than 90 days
after receipt of a grant under paragraph (1), and every
2 years thereafter, each State (or political
subdivisions thereof,) Tribe, or territory receiving a
grant under paragraph (1) shall submit to the
Secretary, and publish on a publicly accessible
internet website of the State (or political
subdivisions thereof), Tribe, or territory--
(A) the plan of the State (or political
subdivisions thereof), Tribe, or territory,
with respect to the promotion of recovery
housing for individuals with a substance use
disorder located within the jurisdiction of
such State (or political subdivisions thereof),
Tribe, or territory; and
(B) a description of how such plan is
consistent with the best practices developed
under this section.
TITLE VII--HEALTH PROFESSIONS EDUCATION
* * * * * * *
PART D--INTERDISCIPLINARY, COMMUNITY-BASED LINKAGES
* * * * * * *
SEC. 756. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
(a) Grants Authorized.--The Secretary may award grants to
eligible institutions to support the recruitment of students
for, and education and clinical experience of the students in--
(1) accredited institutions of higher education or
accredited professional training programs that are
establishing or expanding internships or other field
placement programs in mental health in psychiatry,
psychology, school psychology, behavioral pediatrics,
psychiatric nursing (which may include master's and
doctoral level programs), social work, school social
work, substance use disorder prevention and treatment,
marriage and family therapy, occupational therapy
(which may include master's and doctoral level
programs), school counseling, or professional
counseling, including such programs with a focus on
child and adolescent mental health, trauma, and
transitional-age youth;
(2) accredited doctoral, internship, and post-
doctoral residency programs of health service
psychology (including clinical psychology, counseling,
and school psychology) for the development and
implementation of interdisciplinary training of
psychology graduate students for providing behavioral
health services, including trauma-informed care and
substance use disorder prevention and treatment
services, as well as the development of faculty in
health service psychology;
(3) accredited master's and doctoral degree programs
of social work for the development and implementation
of interdisciplinary training of social work graduate
students for providing behavioral health services,
including trauma-informed care and substance use
disorder prevention and treatment services, and the
development of faculty in social work; and
(4) State-licensed mental health nonprofit and for-
profit organizations to enable such organizations to
pay for programs for preservice or in-service training
in a behavioral health-related paraprofessional field
with preference for preservice or in-service training
of paraprofessional child and adolescent mental health
workers.
(b) Eligibility Requirements.--To be eligible for a grant
under this section, an institution shall demonstrate--
(1) an ability to recruit and place the students
described in subsection (a) in areas with a high need
and high demand population;
(2) participation in the institutions' programs of
individuals and groups from different racial, ethnic,
cultural, geographic, religious, linguistic, and class
backgrounds, and different genders and sexual
orientations;
(3) knowledge and understanding of the concerns of
the individuals and groups described in paragraph (2),
especially individuals with mental disorder symptoms or
diagnoses, particularly children and adolescents, and
transitional-age youth;
(4) any internship or other field placement program
assisted under the grant will prioritize cultural and
linguistic competency; and
(5) the institution will provide to the Secretary
such data, assurances, and information as the Secretary
may require.
(c) Institutional Requirement.--For grants awarded under
paragraphs (2) and (3) of subsection (a), at least 4 of the
grant recipients shall be historically black colleges or
universities or other minority-serving institutions.
(d) Priority.--In selecting grant recipients under this
section, the Secretary shall give priority to--
(1) programs that have demonstrated the ability to
train psychology, psychiatry, and social work
professionals to work in integrated care settings for
purposes of recipients under paragraphs (1), (2), and
(3) of subsection (a); and
(2) programs for paraprofessionals that emphasize the
role of the family and the lived experience of the
consumer and family-paraprofessional partnerships for
purposes of recipients under subsection (a)(4).
(e) Report to Congress.--Not later than 4 years after the
date of enactment of the Helping Families in Mental Health
Crisis Reform Act of 2016, the Secretary shall include in the
biennial report submitted to Congress under section 501(m) an
assessment on the effectiveness of the grants under this
section in--
(1) providing graduate students support for
experiential training (internship or field placement);
(2) recruiting students interested in behavioral
health practice;
(3) recruiting students in accordance with subsection
(b)(1);
(4) developing and implementing interprofessional
training and integration within primary care;
(5) developing and implementing accredited field
placements and internships; and
(6) collecting data on the number of students trained
in behavioral health care and the number of available
accredited internships and field placements.
(f) Authorization of Appropriations.--[For each of fiscal
years 2019 through 2023] For each of fiscal years 2023 through
2027, there are authorized to be appropriated to carry out this
section $50,000,000, to be allocated as follows:
(1) For grants described in subsection (a)(1),
$15,000,000.
(2) For grants described in subsection (a)(2),
$15,000,000.
(3) For grants described in subsection (a)(3),
$10,000,000.
(4) For grants described in subsection (a)(4),
$10,000,000.
* * * * * * *
SEC. 760. TRAINING DEMONSTRATION PROGRAM.
(a) In General.--The Secretary shall establish a training
demonstration program to award grants to eligible entities to
support--
(1) training for medical residents and fellows to
practice psychiatry and addiction medicine in
underserved, community-based settings that integrate
primary care with mental and substance use disorders
prevention and treatment services;
(2) training for nurse practitioners, physician
assistants, health service psychologists, and social
workers to provide mental and substance use disorders
services in underserved community-based settings that
integrate primary care and mental and substance use
disorders services; and
(3) establishing, maintaining, or improving academic
units or programs that--
(A) provide training for students or faculty,
including through clinical experiences and
research, to improve the ability to be able to
recognize, diagnose, and treat mental and
substance use disorders, with a special focus
on addiction; or
(B) develop evidence-based practices or
recommendations for the design of the units or
programs described in subparagraph (A),
including curriculum content standards.
(b) Activities.--
(1) Training for residents and fellows.--A recipient
of a grant under subsection (a)(1)--
(A) shall use the grant funds--
(i)(I) to plan, develop, and operate
a training program for medical
psychiatry residents and fellows in
addiction medicine practicing in
eligible entities described in
subsection (c)(1); or
(II) to train new psychiatric
residents and fellows in addiction
medicine to provide and expand access
to integrated mental and substance use
disorders services; and
(ii) to provide at least 1 training
track that is--
(I) a virtual training track
that includes an in-person
rotation at a teaching health
center or in a community-based
setting, followed by a virtual
rotation in which the resident
or fellow continues to support
the care of patients at the
teaching health center or in
the community-based setting
through the use of health
information technology and, as
appropriate, telehealth
services;
(II) an in-person training
track that includes a rotation,
during which the resident or
fellow practices at a teaching
health center or in a
community-based setting; or
(III) an in-person training
track that includes a rotation
during which the resident
practices in a community-based
setting that specializes in the
treatment of infants, children,
adolescents, or pregnant or
postpartum women; and
(B) may use the grant funds to provide
additional support for the administration of
the program or to meet the costs of projects to
establish, maintain, or improve faculty
development, or departments, divisions, or
other units necessary to implement such
training.
(2) Training for other providers.--A recipient of a
grant under subsection (a)(2)--
(A) shall use the grant funds to plan,
develop, or operate a training program to
provide mental and substance use disorders
services in underserved, community-based
settings, as appropriate, that integrate
primary care and mental and substance use
disorders prevention and treatment services;
and
(B) may use the grant funds to provide
additional support for the administration of
the program or to meet the costs of projects to
establish, maintain, or improve faculty
development, or departments, divisions, or
other units necessary to implement such
program.
(3) Academic units or programs.--A recipient of a
grant under subsection (a)(3) shall enter into a
partnership with organizations such as an education
accrediting organization (such as the Liaison Committee
on Medical Education, the Accreditation Council for
Graduate Medical Education, the Commission on
Osteopathic College Accreditation, the Accreditation
Commission for Education in Nursing, the Commission on
Collegiate Nursing Education, the Accreditation Council
for Pharmacy Education, the Council on Social Work
Education, American Psychological Association
Commission on Accreditation, or the Accreditation
Review Commission on Education for the Physician
Assistant) to carry out activities under subsection
(a)(3).
(c) Eligible Entities.--
(1) Training for residents and fellows.--To be
eligible to receive a grant under subsection (a)(1), an
entity shall--
(A) be a consortium consisting of--
(i) at least one teaching health
center; and
(ii) the sponsoring institution (or
parent institution of the sponsoring
institution) of--
(I) a psychiatry residency
program that is accredited by
the Accreditation Council of
Graduate Medical Education (or
the parent institution of such
a program); or
(II) a fellowship in
addiction medicine, as
determined appropriate by the
Secretary; or
(B) be an entity described in subparagraph
(A)(ii) that provides opportunities for
residents or fellows to train in community-
based settings that integrate primary care with
mental and substance use disorders prevention
and treatment services.
(2) Training for other providers.--To be eligible to
receive a grant under subsection (a)(2), an entity
shall be--
(A) a teaching health center (as defined in
section 749A(f));
(B) a Federally qualified health center (as
defined in section 1905(l)(2)(B) of the Social
Security Act);
(C) a community mental health center (as
defined in section 1861(ff)(3)(B) of the Social
Security Act);
(D) a rural health clinic (as defined in
section 1861(aa) of the Social Security Act);
(E) a health center operated by the Indian
Health Service, an Indian tribe, a tribal
organization, or an urban Indian organization
(as defined in section 4 of the Indian Health
Care Improvement Act); or
(F) an entity with a demonstrated record of
success in providing training for nurse
practitioners, physician assistants, health
service psychologists, and social workers.
(3) Academic units or programs.--To be eligible to
receive a grant under subsection (a)(3), an entity
shall be a school of medicine or osteopathic medicine,
a nursing school, a physician assistant training
program, a school of pharmacy, a school of social work,
an accredited public or nonprofit private hospital, an
accredited medical residency program, or a public or
private nonprofit entity which the Secretary has
determined is capable of carrying out such grant.
(d) Priority.--
(1) In general.--In awarding grants under subsection
(a)(1) or (a)(2), the Secretary shall give priority to
eligible entities that--
(A) demonstrate sufficient size, scope, and
capacity to undertake the requisite training of
an appropriate number of psychiatric residents,
fellows, nurse practitioners, physician
assistants, or social workers in addiction
medicine per year to meet the needs of the area
served;
(B) demonstrate experience in training
providers to practice team-based care that
integrates mental and substance use disorder
prevention and treatment services with primary
care in community-based settings;
(C) demonstrate experience in using health
information technology and, as appropriate,
telehealth to support--
(i) the delivery of mental and
substance use disorders services at the
eligible entities described in
subsections (c)(1) and (c)(2); and
(ii) community health centers in
integrating primary care and mental and
substance use disorders treatment; or
(D) have the capacity to expand access to
mental and substance use disorders services in
areas with demonstrated need, as determined by
the Secretary, such as tribal, rural, or other
underserved communities.
(2) Academic units or programs.--In awarding grants
under subsection (a)(3), the Secretary shall give
priority to eligible entities that--
(A) have a record of training the greatest
percentage of mental and substance use
disorders providers who enter and remain in
these fields or who enter and remain in
settings with integrated primary care and
mental and substance use disorder prevention
and treatment services;
(B) have a record of training individuals who
are from underrepresented minority groups,
including native populations, or from a rural
or disadvantaged background;
(C) provide training in the care of
vulnerable populations such as infants,
children, adolescents, pregnant and postpartum
women, older adults, homeless individuals,
victims of abuse or trauma, individuals with
disabilities, and other groups as defined by
the Secretary;
(D) teach trainees the skills to provide
interprofessional, integrated care through
collaboration among health professionals; or
(E) provide training in cultural competency
and health literacy.
(e) Duration.--Grants awarded under this section shall be for
a minimum of 5 years.
(f) Study and Report.--
(1) Study.--
(A) In general.--The Secretary, acting
through the Administrator of the Health
Resources and Services Administration, shall
conduct a study on the results of the
demonstration program under this section.
(B) Data submission.--Not later than 90 days
after the completion of the first year of the
training program and each subsequent year that
the program is in effect, each recipient of a
grant under subsection (a) shall submit to the
Secretary such data as the Secretary may
require for analysis for the report described
in paragraph (2).
(2) Report to congress.--Not later than 1 year after
receipt of the data described in paragraph (1)(B), the
Secretary shall submit to Congress a report that
includes--
(A) an analysis of the effect of the
demonstration program under this section on the
quality, quantity, and distribution of mental
and substance use disorders services;
(B) an analysis of the effect of the
demonstration program on the prevalence of
untreated mental and substance use disorders in
the surrounding communities of health centers
participating in the demonstration; and
(C) recommendations on whether the
demonstration program should be expanded.
(g) Authorization of Appropriations.--There are authorized to
be appropriated to carry out this section $10,000,000 for each
of fiscal years 2018 through 2022 and $31,700,000 for each of
fiscal years 2023 through 2027.
* * * * * * *
TITLE XIX--BLOCK GRANTS
* * * * * * *
Part B--Block Grants Regarding Mental Health and [Substance Abuse]
Substance Use
Subpart I--Block Grants for Community Mental Health Services
* * * * * * *
SEC. 1912. STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH
SERVICES FOR CERTAIN INDIVIDUALS.
(a) In General.--The Secretary may make a grant under section
1911 only if--
(1) the State involved submits to the Secretary a
plan for providing comprehensive community mental
health services to adults with a serious mental illness
and to children with a serious emotional disturbance;
(2) the plan meets the criteria specified in
subsection (b); and
(3) the plan is approved by the Secretary.
(b) Criteria for Plan.--In accordance with subsection (a), a
State shall submit to the Secretary a plan every two years
that, at a minimum, includes each of the following:
(1) System of care.--A description of the State's
system of care that contains the following:
(A) Comprehensive community-based health
systems.--The plan shall--
(i) identify the single State agency
to be responsible for the
administration of the program under the
grant, including any third party who
administers mental health services and
is responsible for complying with the
requirements of this part with respect
to the grant;
(ii) provide for an organized
community-based system of care for
individuals with mental illness, and
describe available services and
resources in a comprehensive system of
care, including services for
individuals with co-occurring
disorders;
(iii) include a description of the
manner in which the State and local
entities will coordinate services to
maximize the efficiency, effectiveness,
quality, and cost-effectiveness of
services and programs to produce the
best possible outcomes (including
health services, rehabilitation
services, employment services, housing
services, educational services,
substance use disorder services, legal
services, law enforcement services,
social services, child welfare
services, medical and dental care
services, and other support services to
be provided with Federal, State, and
local public and private resources)
with other agencies to enable
individuals receiving services to
function outside of inpatient or
residential institutions, to the
maximum extent of their capabilities,
including services to be provided by
local school systems under the
Individuals with Disabilities Education
Act;
(iv) include a description of how the
State promotes evidence-based
practices, including those evidence-
based programs that address the needs
of individuals with early serious
mental illness regardless of the age of
the individual at onset, provide
comprehensive individualized treatment,
or integrate mental and physical health
services;
(v) include a description of case
management services;
(vi) include a description of
activities that seek to engage adults
with a serious mental illness or
children with a serious emotional
disturbance and their caregivers where
appropriate in making health care
decisions, including activities that
enhance communication among
individuals, families, caregivers, and
treatment providers; and
(vii) as appropriate to, and
reflective of, the uses the State
proposes for the block grant funds,
include--
(I) a description of the
activities intended to reduce
hospitalizations and hospital
stays using the block grant
funds;
(II) a description of the
activities intended to reduce
incidents of suicide using the
block grant funds;
(III) a description of how
the State integrates mental
health and primary care using
the block grant funds, which
may include providing, in the
case of individuals with co-
occurring mental and substance
use disorders, both mental and
substance use disorders
services in primary care
settings or arrangements to
provide primary and specialty
care services in community-
based mental and substance use
disorders settings; [and]
(IV) a description of
recovery and recovery support
services for adults with a
serious mental illness and
children with a serious
emotional disturbance[.]; and
(V) a description of any
evidence-based early
intervention strategies and
programs the State provides to
prevent, delay, or reduce the
severity and onset of mental
illness and behavioral
problems, including for
children and adolescents,
irrespective of experiencing a
serious mental illness or
serious emotional disturbance,
as defined under subsection
(c)(1).
(B) Mental health system data and
epidemiology.--The plan shall containan
estimate of the incidence and prevalence in the
State of serious mental illness among adults
and serious emotional disturbance among
children and present quantitative targets and
outcome measures for programs and services
provided under this subpart.
(C) Children's services.--In the case of
children with a serious emotional disturbance
(as defined pursuant to subsection (c)), the
plan shall provide for a system of integrated
social services, educational services, child
welfare services, juvenile justice services,
law enforcement services, and substance use
disorder services that, together with health
and mental health services, will be provided in
order for such children to receive care
appropriate for their multiple needs (such
system to include services provided under the
Individuals with Disabilities Education Act).
(D) Targeted services to rural and homeless
populations.--Theplan shall describe the
State's outreach to and services for
individuals who are homeless and how community-
based services will be provided to individuals
residing in rural areas.
(E) Management services.--The plan shall
describe the financial resources available, the
existing mental health workforce, and the
workforce trained in treating individuals with
co-occurring mental and substance use
disorders, and shall provide for the training
of providers of emergency health services
regarding mental health. The plan shall further
describe the manner in which the State intends
to expend the grant under section 1911 for the
fiscal year involved, and the manner in which
the State intends to comply with each of the
funding agreements in this subpart and subpart
III.
(2) Goals and objectives.--The establishment of goals
and objectives for the period of the plan, including
targets and milestones that are intended to be met, and
the activities that will be undertaken to achieve those
targets.
(c) Definitions Regarding Mental Illness and Emotional
Disturbance; Methods for Estimate of Incidence and
Prevalence.--
(1) Establishment by secretary of definitions;
dissemination.--For purposes of this subpart, the
Secretary shall establish definitions for the terms
``adults with a serious mental illness'' and ``children
with a serious emotional disturbance''. The Secretary
shall disseminate the definitions to the States.
(2) Standardized methods.--The Secretary shall
establish standardized methods for making the estimates
required in subsection (b)(11) with respect to a State.
A funding agreement for a grant under section 1911 for
the State is that the State will utilize such methods
in making the estimates.
(3) Date certain for compliance by secretary.--Not
later than 90 days after the date of the enactment of
the ADAMHA Reorganization Act, the Secretary shall
establish the definitions described in paragraph (1),
shall begin dissemination of the definitions to the
States, and shall establish the standardized methods
described in paragraph (2).
(d) Requirement of Implementation of Plan.--
(1) Complete implementation.--Except as provided in
paragraph (2), in making a grant under section 1911 to
a State for a fiscal year, the Secretary shall make a
determination of the extent to which the State has
implemented the plan required in subsection (a). If the
Secretary determines that a State has not completely
implemented the plan, the Secretary shall reduce the
amount of the allotment under section 1911 for the
State for the fiscal year involved by an amount equal
to 10 percent of the amount determined under section
1918 for the State for the fiscal year.
(2) Substantial implementation and good faith effort
regarding fiscal year 1993.--
(A) In making a grant under section 1911 to a
State for fiscal year 1993, the Secretary shall
make a determination of the extent to which the
State has implemented the plan required in
subsection (a). If the Secretary determines
that the State has not substantially
implemented the plan, the Secretary shall,
subject to subparagraph (B), reduce the amount
of the allotment under section 1911 for the
State for such fiscal year by an amount equal
to 10 percent of the amount determined under
section 1918 for the State for the fiscal year.
(B) In carrying out subparagraph (A), if the
Secretary determines that the State is making a
good faith effort to implement the plan
required in subsection (a), the Secretary may
make a reduction under such subparagraph in an
amount that is less than the amount specified
in such subparagraph, except that the reduction
may not be made in an amount that is less than
5 percent of the amount determined under
section 1918 for the State for fiscal year
1993.
* * * * * * *
SEC. 1920. FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this subpart, and subpart III and section 505(c)
with respect to mental health, there are authorized to be
appropriated [$532,571,000 for each of fiscal years 2018
through 2022] $857,571,000 for each of fiscal years 2023
through 2027.
(b) Allocations for Technical Assistance, Data Collection,
and Program Evaluation.--
(1) In general.--For the purpose of carrying out
section 1948(a) with respect to mental health and the
purposes specified in paragraphs (2) and (3), the
Secretary shall obligate 5 percent of the amounts
appropriated under subsection (a) for a fiscal year.
(2) Data collection.--The purpose specified in this
paragraph is carrying out sections 505(c) and 1971 with
respect to mental health.
(3) Program evaluation.--The purpose specified in
this paragraph is the conduct of evaluations of
prevention and treatment programs and services with
respect to mental health to determine methods for
improving the availability and quality of such programs
and services.
(c) Early Serious Mental Illness.--
(1) In general.--Except as provided in paragraph (2),
a State shall expend not less than 10 percent of the
amount the State receives for carrying out this section
for each fiscal year to support evidence-based programs
that address the needs of individuals with early
serious mental illness, including psychotic disorders,
regardless of the age of the individual at onset.
(2) State flexibility.--In lieu of expending 10
percent of the amount the State receives under this
section for a fiscal year as required under paragraph
(1), a State may elect to expend not less than 20
percent of such amount by the end of such succeeding
fiscal year.
(d) Crisis Care.--
(1) In general.--Except as provided in paragraph (3),
a State shall expend at least 5 percent of the amount
the State receives pursuant to section 1911 for each
fiscal year to support evidenced-based programs that
address the crisis care needs of--
(A) individuals, including children and
adolescents, experiencing mental health crises,
substance-related crises, or crises arising
from co-occurring disorders; and
(B) persons with intellectual and
developmental disabilities.
(2) Core elements.--At the discretion of the single
State agency responsible for the administration of the
program of the State under a grant under section 1911,
funds expended pursuant to paragraph (1) may be used to
fund some or all of the core crisis care service
components, delivered according to evidence-based
principles, including the following:
(A) Crisis call centers.
(B) 24/7 mobile crisis services.
(C) Crisis stabilization programs offering
acute care or subacute care in a hospital or
appropriately licensed facility, as determined
by the Substance Abuse and Mental Health
Services Administration, with referrals to
inpatient or outpatient care.
(3) State flexibility.--In lieu of expending 5
percent of the amount the State receives pursuant to
section 1911 for a fiscal year to support evidence-
based programs as required by paragraph (1), a State
may elect to expend not less than 10 percent of such
amount to support such programs by the end of two
consecutive fiscal years.
(4) Rule of construction.--With respect to funds
expended pursuant to the set-aside in paragraph (1),
section 1912(b)(1)(A)(vi) shall not apply.
(e) Early Intervention Services.--In the case of a State with
a State plan that provides for strategies and programs
specified in section 1912(b)(1)(A)(vii)(VI), such State may
expend not more than 5 percent of the amount of the allotment
of the State pursuant to a funding agreement under section 1911
for each fiscal year to support such strategies and programs.
(f) Reports to Congress.--Not later than September 30, 2025,
and biennially thereafter, the Secretary shall provide a report
to the Congress on the crisis care and early intervention
strategies and programs pursued by States pursuant to
subsections (d) and (e). Each such report shall include--
(1) a description of the each State's crisis care and
early intervention activities;
(2) the population served, including information on
demographics, including age;
(3) the outcomes of such activities, including--
(A) how such activities reduced
hospitalizations and hospital stays;
(B) how such activities reduced incidents of
suicidal ideation and behaviors; and
(C) how such activities reduced the severity
of onset of serious mental illness and serious
emotional disturbance; and
(4) any other relevant information the Secretary
deems necessary.
Subpart II--[Block Grants for Prevention and Treatment of Substance
Abuse] Block Grants for Substance Use Prevention, Treatment, and
Recovery Services
SEC. 1921. FORMULA GRANTS TO STATES.
(a) In General.--For the purpose described in subsection (b),
the Secretary, acting through the Center for Substance Abuse
Treatment, shall make an allotment each fiscal year for each
State in an amount determined in accordance with section 1933.
The Secretary shall make a grant to the State of the allotment
made for the State for the fiscal year if the State submits to
the Secretary an application in accordance with section 1932.
(b) Authorized Activities.--A funding agreement for a grant
under subsection (a) is that, subject to section 1931, the
State involved will expend the grant only for the purpose of
carrying out the plan developed in accordance with section
1932(b) and for planning, carrying out, and evaluating
activities to [prevent and treat substance use disorders]
prevent, treat, and provide recovery support services for
substance use disorders and for related activities authorized
in section 1924.
SEC. 1922. CERTAIN ALLOCATIONS.
(a) Allocation Regarding Primary Prevention Programs.--A
funding agreement for a grant under section 1921 is that, in
expending the grant, the State involved--
(1) will expend not less than 20 percent for programs
for individuals who do not require treatment for
[substance abuse] substance use disorders, which
programs--
(A) educate and counsel the individuals on
[such abuse] such disorders; and
(B) provide for activities to reduce the risk
of [such abuse] such disorders by the
individuals;
(2) will, in carrying out paragraph (1)--
(A) give priority to programs for populations
that are at risk of developing a pattern of
[such abuse] such disorders; and
(B) ensure that programs receiving priority
under subparagraph (A) develop community-based
strategies for the prevention of [such abuse]
such disorders, including strategies to
discourage the use of alcoholic beverages and
tobacco products by individuals to whom it is
unlawful to sell or distribute such beverages
or products.
(b) Allocations Regarding Women.--
(1) In general.--Subject to paragraph (2), a funding
agreement for a grant under section 1921 for a fiscal
year is that--
(A) in the case of a grant for fiscal year
1993, the State involved will expend not less
than 5 percent of the grant to increase
(relative to fiscal year 1992) the availability
of treatment services designed for pregnant
women and women with dependent children (either
by establishing new programs or expanding the
capacity of existing programs);
(B) in the case of a grant for fiscal year
1994, the State will expend not less than 5
percent of the grant to so increase (relative
to fiscal year 1993) the availability of such
services for such women; and
(C) in the case of a grant for any subsequent
fiscal year, the State will expend for such
services for such women not less than an amount
equal to the amount expended by the State for
fiscal year 1994.
(2) Waiver.--
(A) Upon the request of a State, the
Secretary may provide to the State a waiver of
all or part of the requirement established in
paragraph (1) if the Secretary determines that
the State is providing an adequate level of
treatments services for women described in such
paragraph, as indicated by a comparison of the
number of such women seeking the services with
the availability in the State of the services.
(B) The Secretary shall approve or deny a
request for a waiver under subparagraph (A) not
later than 120 days after the date on which the
request is made.
(C) Any waiver provided by the Secretary
under subparagraph (A) shall be applicable only
to the fiscal year involved.
(3) Childcare and prenatal care.--A funding agreement
for a grant under section 1921 for a State is that each
entity providing treatment services with amounts
reserved under paragraph (1) by the State will,
directly or through arrangements with other public or
nonprofit private entities, make available prenatal
care to women receiving such services and, while the
women are receiving the services, childcare.
SEC. 1923. INTRAVENOUS [SUBSTANCE ABUSE] SUBSTANCE USE.
(a) Capacity of Treatment Programs.--
(1) Notification of reaching capacity.--A funding
agreement for a grant under section 1921 is that the
State involved will, in the case of programs of
treatment for intravenous [drug abuse] substance use
disorders, require that any such program receiving
amounts from the grant, upon reaching 90 percent of its
capacity to admit individuals to the program, provide
to the State a notification of such fact.
(2) Provision of treatment.--A funding agreement for
a grant under section 1921 is that the State involved
will, with respect to notifications under paragraph
(1), ensure that each individual who requests and is in
need of treatment for intravenous [drug abuse]
substance use disorders is admitted to a program of
such treatment not later than--
(A) 14 days after making the request for
admission to such a program; or
(B) 120 days after the date of such request,
if no such program has the capacity to admit
the individual on the date of such request and
if interim services are made available to the
individual not later than 48 hours after such
request.
(b) Outreach to Persons Who Inject Drugs.--A funding
agreement for a grant under section 1921 is that the State
involved, in providing amounts from the grant to any entity for
treatment services for persons who inject drugs, will require
the entity to carry out activities to encourage individuals in
need of such treatment to undergo treatment.
SEC. 1924. REQUIREMENTS REGARDING [TUBERCULOSIS AND HUMAN
IMMUNODEFICIENCY VIRUS] TUBERCULOSIS, VIRAL
HEPATITIS, AND HUMAN IMMUNODEFICIENCY VIRUS.
(a) Tuberculosis.--
(1) In general.--A funding agreement for a grant
under section 1921 is that the State involved will
require that any entity receiving amounts from the
grant for operating a program of treatment for
substance use disorders--
(A) will, directly or through arrangements
with other public or nonprofit private
entities, routinely make available tuberculosis
services to each individual receiving treatment
for such disorders; and
(B) in the case of an individual in need of
such treatment who is denied admission to the
program on the basis of the lack of the
capacity of the program to admit the
individual, will refer the individual to
another provider of tuberculosis services.
[(2) Tuberculosis services.--For purposes of
paragraph (1), the term ``tuberculosis services'', with
respect to an individual, means--
[(A) counseling the individual with respect
to tuberculosis;
[(B) testing to determine whether the
individual has contracted such disease and
testing to determine the form of treatment for
the disease that is appropriate for the
individual; and
[(C) providing such treatment to the
individual.]
(2) Designated states.--
(A) Fiscal years through fiscal year 2024.--
For purposes of this subsection, through
September 30, 2024, a State described in this
paragraph is any State whose rate of cases of
acquired immune deficiency syndrome is 10 or
more such cases per 100,000 individuals (as
indicated by the number of such cases reported
to and confirmed by the Director of the Centers
for Disease Control and Prevention for the most
recent calendar year for which such data are
available).
(B) Fiscal year 2025 and succeeding fiscal
years.--
(i) In general.--Beginning with
fiscal year 2025, for purposes of this
subsection, a State described in this
paragraph is any State whose rate of
cases of human immunodeficiency virus
is 10 or more such cases per 100,000
individuals (as indicated by the number
of such cases newly reported to and
confirmed by the Director of the
Centers for Disease Control and
Prevention for the most recent calendar
year for which such data are
available).
(ii) Continuation of designated state
status.--In the case of a State whose
rate of cases of human immunodeficiency
virus falls below the threshold
specified in clause (i) for a calendar
year, such State shall, notwithstanding
clause (i), continue to be described in
this paragraph unless the rate of cases
falls below such threshold for three
consecutive calendar years.
(b) Human Immunodeficiency Virus.--
(1) Requirement for certain states.--In the case of a
State described in paragraph (2), a funding agreement
for a grant under section 1921 is that--
(A) with respect to individuals undergoing
treatment for substance use disorders, the
State will, subject to paragraph (3), carry out
1 or more projects to make available to the
individuals early intervention services for HIV
disease at the sites at which the individuals
are undergoing such treatment;
(B) for the purpose of providing such early
intervention services through such projects,
the State will make available from the grant
the percentage that is applicable for the State
under paragraph (4); and
(C) the State will, subject to paragraph (5),
carry out such projects only in geographic
areas of the State that have the greatest need
for the projects.
(2) Designated states.--For purposes of this
subsection, a State described in this paragraph is any
State whose rate of cases of acquired immune deficiency
syndrome is 10 or more such cases per 100,000
individuals (as indicated by the number of such cases
reported to and confirmed by the Director of the
Centers for Disease Control and Prevention for the most
recent calendar year for which such data are
available).
(3) Use of existing programs regarding substance use
disorders.--With respect to programs that provide
treatment services for substance use disorders, a
funding agreement for a grant under section 1921 for a
designated State is that each such program
participating in a project under paragraph (1) will be
a program that began operation prior to the fiscal year
for which the State is applying to receive the grant. A
program that so began operation may participate in a
project under paragraph (1) without regard to whether
the program has been providing early intervention
services for HIV disease.
(4) Applicable percentage regarding expenditures for
services.--
(A)(i) For purposes of paragraph (1)(B), the
percentage that is applicable under this
paragraph for a designated State is, subject to
subparagraph (B), the percentage by which the
amount of the grant under section 1921 for the
State for the fiscal year involved is an
increase over the amount specified in clause
(ii).
(ii) The amount specified in this clause is
the amount that was reserved by the designated
State involved from the allotment of the State
under section 1912A for fiscal year 1991 in
compliance with section 1916(c)(6)(A)(ii) (as
such sections were in effect for such fiscal
year).
(B) If the percentage determined under
subparagraph (A) for a designated State for a
fiscal year is less than 2 percent (including a
negative percentage, in the case of a State for
which there is no increase for purposes of such
subparagraph), the percentage applicable under
this paragraph for the State is 2 percent. If
the percentage so determined is 2 percent or
more, the percentage applicable under this
paragraph for the State is the percentage
determined under subparagraph (A), subject to
not exceeding 5 percent.
(5) Requirement regarding rural areas.--
(A) A funding agreement for a grant under
section 1921 for a designated State is that, if
the State will carry out 2 or more projects
under paragraph (1), the State will carry out 1
such project in a rural area of the State,
subject to subparagraph (B).
(B) The Secretary shall waive the requirement
established in subparagraph (A) if the State
involved certifies to the Secretary that--
(i) there is insufficient demand in
the State to carry out a project under
paragraph (1) in any rural area of the
State; or
(ii) there are no rural areas in the
State.
(6) Manner of providing services.--With respect to
the provision of early intervention services for HIV
disease to an individual, a funding agreement for a
grant under section 1921 for a designated State is
that--
(A) such services will be undertaken
voluntarily by, and with the informed consent
of, the individual; and
(B) undergoing such services will not be
required as a condition of receiving treatment
services for substance use disorders or any
other services.
(7) Definitions.--For purposes of this subsection:
(A) The term ``designated State'' means a
State described in paragraph (2).
(B) The term ``early intervention services'',
with respect to HIV disease, means--
(i) appropriate pretest counseling;
(ii) testing individuals with respect
to such disease, including tests to
confirm the presence of the disease,
tests to diagnose the extent of the
deficiency in the immune system, and
tests to provide information on
appropriate therapeutic measures for
preventing and treating the
deterioration of the immune system and
for preventing and treating conditions
arising from the disease;
(iii) appropriate post-test
counseling; and
(iv) providing the therapeutic
measures described in clause (ii).
(C) The term ``HIV disease'' means infection
with the etiologic agent for acquired immune
deficiency syndrome.
(c) Viral Hepatitis.--
(1) In general.--A funding agreement for a grant
under section 1921 is that the State involved will
require that any entity receiving amounts from the
grant for operating a program of treatment for
substance use disorders--
(A) will, directly or through arrangements
with other public or nonprofit private
entities, routinely make available viral
hepatitis services to each individual receiving
treatment for such disorders; and
(B) in the case of an individual in need of
such treatment who is denied admission to the
program on the basis of the lack of the
capacity of the program to admit the
individual, will refer the individual to
another provider of viral hepatitis services.
(2) Viral hepatitis services.--For purposes of
paragraph (1), the term ``viral hepatitis services'',
with respect to an individual, means--
(A) screening the individual for viral
hepatitis; and
(B) referring the individual to a provider
whose practice includes viral hepatitis
vaccination and treatment.
[(c)] (d) Expenditure of Grant for Compliance With
Agreements.--
(1) In general.--A grant under section 1921 may be
expended for purposes of compliance with the agreements
required in this section, subject to paragraph (2).
(2) Limitation.--A funding agreement for a grant
under section 1921 for a State is that the grant will
not be expended to make payment for any service
provided for purposes of compliance with this section
to the extent that payment has been made, or can
reasonably be expected to be made, with respect to such
service--
(A) under any State compensation program,
under any insurance policy, or under any
Federal or State health benefits program
(including the program established in title
XVIII of the Social Security Act and the
program established in title XIX of such Act);
or
(B) by an entity that provides health
services on a prepaid basis.
[(d)] (e) Applicability of Certain Provision.--Section 1931
applies to this section (and to each other provision of this
subpart).
SEC. 1925. GROUP HOMES FOR PERSONS IN RECOVERY FROM SUBSTANCE USE
DISORDERS.
(a) State Revolving Funds for Establishment of Homes.--A
State, using funds available under section 1921, may establish
and maintain the ongoing operation of a revolving fund in
accordance with this section to support group homes for persons
in recovery from substance use disorders as follows:
(1) The purpose of the fund is to make loans for the
costs of establishing programs for the provision of
housing in which individuals recovering from [alcohol
or drug abuse] alcohol or other substance use disorders
may reside in groups of not less than 6 individuals.
The fund is established directly by the State or
through the provision of a grant or contract to a
nonprofit private entity.
(2) The programs are carried out in accordance with
guidelines issued under subsection (b).
(3) Not less than $100,000 is available for the fund.
(4) Loans made from the revolving fund do not exceed
$4,000 and each such loan is repaid to the revolving
fund by the residents of the housing involved not later
than 2 years after the date on which the loan is made.
(5) Each such loan is repaid by such residents
through monthly installments, and a reasonable penalty
is assessed for each failure to pay such periodic
installments by the date specified in the loan
agreement involved.
(6) Such loans are made only to nonprofit private
entities agreeing that, in the operation of the program
established pursuant to the loan--
(A) the use of alcohol or any illegal drug in
the housing provided by the program will be
prohibited;
(B) any resident of the housing who violates
such prohibition will be expelled from the
housing;
(C) the costs of the housing, including fees
for rent and utilities, will be paid by the
residents of the housing; and
(D) the residents of the housing will,
through a majority vote of the residents,
otherwise establish policies governing
residence in the housing, including the manner
in which applications for residence in the
housing are approved.
(b) Issuance by Secretary of Guidelines.--The Secretary shall
ensure that there are in effect guidelines under this subpart
for the operation of programs described in subsection (a).
(c) Applicability to Territories.--The requirements
established in subsection (a) shall not apply to any territory
of the United States other than the Commonwealth of Puerto
Rico.
SEC. 1926. SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 21.
(a) In General.--A funding agreement for a grant under
section 1921 is that the State involved will--
(1) annually conduct random, unannounced inspections
to ensure that retailers do not sell tobacco products
to individuals under the age of 21; and
(2) annually submit to the Secretary a report
describing--
(A) the activities carried out by the State
to ensure that retailers do not sell tobacco
products to individuals under the age of 21;
(B) the extent of success the State has
achieved in ensuring that retailers do not sell
tobacco products to individuals under the age
of 21; and
(C) the strategies to be utilized by the
State to ensure that retailers do not sell
tobacco products to individuals under the age
of 21 during the fiscal year for which the
grant is sought.
(b) Noncompliance of State.--
(1) In general.--Before making a grant under section
1921 to a State, the Secretary shall make a
determination of whether the State has maintained
compliance with subsection (a). If, after notice to the
State and an opportunity for a hearing, the Secretary
determines that the State is not in compliance with
such subsections, the Secretary shall reduce the amount
of the allotment under such section for the State for
the fiscal year involved by an amount up to 10 percent
of the amount determined under section 1933 for the
State for the applicable fiscal year.
(2) Limitation.--
(A) In general.--A State shall not have funds
withheld pursuant to paragraph (1) if such
State for which the Secretary has made a
determination of noncompliance under such
paragraph--
(i) certifies to the Secretary by May
1 of the fiscal year for which the
funds are appropriated, consistent with
subparagraph (B), that the State will
commit additional State funds, in
accordance with paragraph (1), to
ensure that retailers do not sell
tobacco products to individuals under
21 years of age;
(ii) agrees to comply with a
negotiated agreement for a corrective
action plan that is approved by the
Secretary and carried out in accordance
with guidelines issued by the
Secretary; or
(iii) is a territory that receives
less than $1,000,000 for a fiscal year
under section 1921.
(B) Certification.--
(i) In general.--The amount of funds
to be committed by a State pursuant to
subparagraph (A)(i) shall be equal to 1
percent of such State's [substance
abuse] allocation determined under
section 1933 for each percentage point
by which the State misses the retailer
compliance rate goal established by the
Secretary.
(ii) State expenditures.--For a
fiscal year in which a State commits
funds as described in clause (i), such
State shall maintain State expenditures
for tobacco prevention programs and for
compliance activities at a level that
is not less than the level of such
expenditures maintained by the State
for the preceding fiscal year, plus the
additional funds for tobacco compliance
activities required under clause (i).
The State shall submit a report to the
Secretary on all State obligations of
funds for such fiscal year and all
State expenditures for the preceding
fiscal year for tobacco prevention and
compliance activities by program
activity by July 31 of such fiscal
year.
(iii) Discretion.--The Secretary
shall exercise discretion in enforcing
the timing of the State obligation of
the additional funds required by the
certification described in subparagraph
(A)(i) as late as July 31 of such
fiscal year.
(C) Failure to certify.--If a State described
in subparagraph (A) fails to certify to the
Secretary pursuant to subparagraph (A)(i) or
enter into, or comply with, a negotiated
agreement under subparagraph (A)(ii), the
Secretary may take action pursuant to paragraph
(1).
(c) Implementation of Reporting Requirements.--
(1) Transition period.--The Secretary shall--
(A) not withhold amounts under subsection (b)
for the 3-year period immediately following the
date of enactment of division N of the Further
Consolidated Appropriations Act, 2020; and
(B) use discretion in exercising its
authority under subsection (b) during the 2-
year period immediately following the 3-year
period described in subparagraph (A), to allow
for a transition period for implementation of
the reporting requirements under subsection
(a)(2).
(2) Regulations or guidance.--Not later than 180 days
after the date of enactment of division N of the
Further Consolidated Appropriations Act, 2020, the
Secretary shall update regulations under part 96 of
title 45, Code of Federal Regulations or guidance on
the retailer compliance rate goal under subsection (b),
the use of funds provided under section 1921 for
purposes of meeting the requirements of this section,
and reporting requirements under subsection (a)(2).
(3) Coordination.--The Secretary shall ensure the
Assistant Secretary for Mental Health and Substance Use
coordinates, as appropriate, with the Commissioner of
Food and Drugs to ensure that the technical assistance
provided to States under subsection (e) is consistent
with applicable regulations for retailers issued under
part 1140 of title 21, Code of Federal Regulations.
(d) Transitional Grants.--
(1) In general.--The Secretary shall award grants
under this subsection to each State that receives
funding under section 1921 to ensure compliance of each
such State with this section.
(2) Use of funds.--A State receiving a grant under
this subsection--
(A) shall use amounts received under such
grant for activities to plan for or ensure
compliance in the State with subsection (a);
and
(B) in the case of a State for which the
Secretary has made a determination under
subsection (b) that the State is prepared to
meet, or has met, the requirements of
subsection (a), may use such funds for tobacco
cessation activities, strategies to prevent the
use of tobacco products by individuals under
the age of 21, or allowable uses under section
1921.
(3) Supplement not supplant.--Grants under this
subsection shall be used to supplement and not supplant
other Federal, State, and local public funds provided
for activities under paragraph (2).
(4) Authorization of appropriations.--To carry out
this subsection, there are authorized to be
appropriated $18,580,790 for each of fiscal years 2020
through 2024.
(5) Sunset.--This subsection shall have no force or
effect after September 30, 2024.
(e) Technical Assistance.--The Secretary shall provide
technical assistance to States related to the activities
required under this section.
* * * * * * *
SEC. 1931. RESTRICTIONS ON EXPENDITURE OF GRANT.
(a) In General.--
(1) Certain restrictions.--A funding agreement for a
grant under section 1921 is that the State involved
will not expend the grant--
(A) to provide inpatient hospital services,
except as provided in subsection (b);
(B) to make cash payments to intended
recipients of health services;
(C) to purchase or improve land, purchase,
construct, or permanently improve (other than
minor remodeling) any building or other
facility, or purchase major medical equipment;
(D) to satisfy any requirement for the
expenditure of non-Federal funds as a condition
for the receipt of Federal funds;
(E) to provide financial assistance to any
entity other than a public or nonprofit private
entity; or
(F) to carry out any program prohibited by
section 256(b) of the Health Omnibus Programs
Extension of 1988 (42 U.S.C. 300ee-5).
(2) Limitation on administrative expenses.--A funding
agreement for a grant under section 1921 is that the
State involved will not expend more than 5 percent of
the grant to pay the costs of administering the grant.
(3) Limitation regarding penal and correctional
institutions.--A funding agreement for a State for a
grant under section 1921 is that, in expending the
grant for the purpose of providing treatment services
in penal or correctional institutions of the State, the
State will not expend more than an amount equal to the
amount expended for such purpose by the State from the
grant made under section 1912A to the State for fiscal
year 1991 (as section 1912A was in effect for such
fiscal year).
(b) Exception Regarding Inpatient Hospital Services.--
(1) Medical necessity as precondition.--With respect
to compliance with the agreement made under subsection
(a), a State may expend a grant under section 1921 to
provide inpatient hospital services as treatment for
substance use disorders only if it has been determined,
in accordance with guidelines issued by the Secretary,
that such treatment is a medical necessity for the
individual involved, and that the individual cannot be
effectively treated in a community-based, nonhospital,
residential program of treatment.
(2) Rate of payment.--In the case of an individual
for whom a grant under section 1921 is expended to
provide inpatient hospital services described in
paragraph (1), a funding agreement for the grant for
the State involved is that the daily rate of payment
provided to the hospital for providing the services to
the individual will not exceed the comparable daily
rate provided for community-based, nonhospital,
residential programs of treatment for [substance abuse]
substance use disorders.
(c) Waiver Regarding Construction of Facilities.--
(1) In general.--The Secretary may provide to any
State a waiver of the restriction established in
subsection (a)(1)(C) for the purpose of authorizing the
State to expend a grant under section 1921 for the
construction of a new facility or rehabilitation of an
existing facility, but not for land acquisition.
(2) Standard regarding need for waiver.--The
Secretary may approve a waiver under paragraph (1) only
if the State demonstrates to the Secretary that
adequate treatment cannot be provided through the use
of existing facilities and that alternative facilities
in existing suitable buildings are not available.
(3) Amount.--In granting a waiver under paragraph
(1), the Secretary shall allow the use of a specified
amount of funds to construct or rehabilitate a
specified number of beds for residential treatment and
a specified number of slots for outpatient treatment,
based on reasonable estimates by the State of the costs
of construction or rehabilitation. In considering
waiver applications, the Secretary shall ensure that
the State has carefully designed a program that will
minimize the costs of additional beds.
(4) Matching funds.--The Secretary may grant a waiver
under paragraph (1) only if the State agrees, with
respect to the costs to be incurred by the State in
carrying out the purpose of the waiver, to make
available non-Federal contributions in cash toward such
costs in an amount equal to not less than $1 for each
$1 of Federal funds provided under section 1921.
(5) Date certain for acting upon request.--The
Secretary shall act upon a request for a waiver under
paragraph (1) not later than 120 days after the date on
which the request is made.
SEC. 1932. APPLICATION FOR GRANT; APPROVAL OF STATE PLAN.
(a) In General.--For purposes of section 1921, an application
for a grant under such section for a fiscal year is in
accordance with this section if, subject to subsection (c)--
(1) the application is received by the Secretary not
later than October 1 of the fiscal year for which the
State is seeking funds;
(2) the application contains each funding agreement
that is described in this subpart or subpart III for
such a grant (other than any such agreement that is not
applicable to the State);
(3) the agreements are made through certification
from the chief executive officer of the State;
(4) with respect to such agreements, the application
provides assurances of compliance satisfactory to the
Secretary;
(5) the application contains the report required in
section 1942(a);
(6)(A) the application contains a plan in accordance
with subsection (b) and the plan is approved by the
Secretary; and
(B) the State provides assurances satisfactory to the
Secretary that the State complied with the provisions
of the plan under subparagraph (A) that was approved by
the Secretary for the most recent fiscal year for which
the State received a grant under section 1921; and
(7) the application (including the plan under
paragraph (6)) is otherwise in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this subpart.
(b) State Plan.--
(1) In general.--In order for a State to be in
compliance with subsection (a)(6), the State shall
submit to the Secretary a plan that, at a minimum,
includes the following:
(A) A description of the State's system of
care that--
(i) identifies the single State
agency responsible for the
administration of the program,
including any third party who
administers substance use disorder
services and is responsible for
complying with the requirements of the
grant;
(ii) provides information on the need
for substance use disorder prevention
and treatment services in the State,
including estimates on the number of
individuals who need treatment, who are
pregnant women, women with dependent
children, individuals with a co-
occurring mental health and substance
use disorder, persons who inject drugs,
and persons who are experiencing
homelessness;
(iii) provides aggregate information
on the number of individuals in
treatment within the State, including
the number of such individuals who are
pregnant women, women with dependent
children, individuals with a co-
occurring mental health and substance
use disorder, persons who inject drugs,
and persons who are experiencing
homelessness;
(iv) provides a description of the
system that is available to provide
services by modality, including the
provision of recovery support services;
(v) provides a description of the
State's comprehensive statewide
prevention efforts, including the
number of individuals being served in
the system, target populations, and
priority needs, and provides a
description of the amount of funds from
the prevention set-aside expended on
primary prevention;
(vi) provides a description of--
(I) the State's comprehensive
statewide recovery support
services activities, including
the number of individuals being
served, target populations, and
priority needs; and
(II) the amount of funds
received under this subpart
expended on recovery support
services, disaggregated by the
amount expended for type of
service activity;
[(vi)] (vii) provides a description
of the financial resources available;
[(vii)] (viii) describes the existing
substance use disorders workforce and
workforce trained in treating co-
occurring substance use and mental
disorders;
[(viii)] (ix) includes a description
of how the State promotes evidence-
based practices; and
[(ix)] (x) describes how the State
integrates substance use disorder
services and primary health care, which
in the case of those individuals with
co-occurring mental health and
substance use disorders may include
providing both mental health and
substance use disorder services in
primary care settings or providing
primary and specialty care services in
community-based mental health and
substance use disorder service
settings.
(B) The establishment of goals and objectives
for the period of the plan, including targets
and milestones that are intended to be met, and
the activities that will be undertaken to
achieve those targets.
(C) A description of how the State will
comply with each funding agreement for a grant
under section 1921 that is applicable to the
State, including a description of the manner in
which the State intends to expend grant funds.
(2) Modifications.--
(A) Authority of secretary.--As a condition;
of making a grant under section 1921 to a State
for a fiscal year, the Secretary may require
that the State modify any provision of the plan
submitted by the State under subsection (a)(6)
(including provisions on priorities in carrying
out authorized activities). If the Secretary
approves the plan and makes the grant to the
State for the fiscal year, the Secretary may
not during such year require the State to
modify the plan.
(B) State request for modification.--If the
State determines that a modification to such
plan is necessary, the State may request the
Secretary to approve the modification. Any such
modification shall be in accordance with
paragraph (1) and section 1941.
(3) Authority of center for substance abuse
prevention.--With respect to plans submitted by the
States under subsection (a)(6), including any
modification under paragraph (2), the Secretary, acting
through the Director of the Center for Substance Abuse
Prevention, shall review and approve or disapprove the
provisions of the plans that relate to prevention
activities.
(c) Waivers Regarding Certain Territories.--In the case of
any territory of the United States except Puerto Rico, the
Secretary may waive such provisions of this subpart and subpart
III as the Secretary determines to be appropriate, other than
the provisions of section 1931.
(d) Issuance of Regulations; Precondition to Making Grants.--
(1) Regulations.--Not later than August 25, 1992, the
Secretary, acting as appropriate through the Director
of the Center for Treatment Improvement or the Director
of the Center for Substance Abuse Prevention, shall by
regulation establish standards specifying the
circumstances in which the Secretary will consider an
application for a grant under section 1921 to be in
accordance with this section.
(2) Issuance as precondition to making grants.--The
Secretary may not make payments under any grant under
section 1921 for fiscal year 1993 on or after January
1, 1993, unless the Secretary has issued standards
under paragraph (1).
(e) Waiver Authority for Certain Requirements.--
(1) In general.--Upon the request of a State, the
Secretary may waive the requirements of all or part of
the sections described in paragraph (2) using objective
criteria established by the Secretary by regulation
after consultation with the States and other interested
parties including consumers and providers.
(2) Sections.--The sections described in paragraph
(1) are sections 1922(b), 1923, 1924 and 1928.
(3) Date certain for acting upon request.--The
Secretary shall approve or deny a request for a waiver
under paragraph (1) and inform the State of that
decision not later than 120 days after the date on
which the request and all the information needed to
support the request are submitted.
(4) Annual reporting requirement.--The Secretary
shall annually report to the general public on the
States that receive a waiver under this subsection.
SEC. 1933. DETERMINATION OF AMOUNT OF ALLOTMENT.
(a) States.--
(1) In general.--Subject to subsection (b), the
Secretary shall determine the amount of the allotment
required in section 1921 for a State for a fiscal year
as follows:
(A) The formula established in paragraph (1)
of section 1918(a) shall apply to this
subsection to the same extent and in the same
manner as the formula applies for purposes of
section 1918(a), except that, in the
application of such formula for purposes of
this subsection, the modifications described in
subparagraph (B) shall apply.
(B) For purposes of subparagraph (A), the
modifications described in this subparagraph
are as follows:
(i) The amount specified in paragraph
(2)(A) of section 1918(a) is deemed to
be the amount appropriated under
section 1935(a) for allotments under
section 1921 for the fiscal year
involved.
(ii) The term ``P'' is deemed to have
the meaning given in paragraph (2) of
this subsection. Section 1918(a)(5)(B)
applies to the data used in determining
such term for the States.
(iii) The factor determined under
paragraph (8) of section 1918(a) is
deemed to have the purpose of
reflecting the differences that exist
between the State involved and other
States in the costs of providing
authorized services.
(2) Determination of term ``p''.--For purposes of
this subsection, the term ``P'' means the percentage
that is the arithmetic mean of the percentage
determined under subparagraph (A) and the percentage
determined under subparagraph (B), as follows:
(A) The percentage constituted by the ratio
of--
(i) an amount equal to the sum of the
total number of individuals who reside
in the State involved and are between
18 and 24 years of age (inclusive) and
the number of individuals in the State
who reside in urbanized areas of the
State and are between such years of
age; to
(ii) an amount equal to the total of
the respective sums determined for the
States under clause (i).
(B) The percentage constituted by the ratio
of--
(i) the total number of individuals
in the State who are between 25 and 64
years of age (inclusive); to
(ii) an amount equal to the sum of
the respective amounts determined for
the States under clause (i).
(b) Minimum Allotments for States.--
(1) In general.--With respect to fiscal year 2000,
and each subsequent fiscal year, the amount of the
allotment of a State under section 1921 shall not be
less than the amount the State received under such
section for the previous fiscal year increased by an
amount equal to 30.65 percent of the percentage by
which the aggregate amount allotted to all States for
such fiscal year exceeds the aggregate amount allotted
to all States for the previous fiscal year.
(2) Limitations.--
(A) In general.--Except as provided in
subparagraph (B), a State shall not receive an
allotment under section 1921 for a fiscal year
in an amount that is less than an amount equal
to 0.375 percent of the amount appropriated
under section 1935(a) for such fiscal year.
(B) Exception.--In applying subparagraph (A),
the Secretary shall ensure that no State
receives an increase in its allotment under
section 1921 for a fiscal year (as compared to
the amount allotted to the State in the prior
fiscal year) that is in excess of an amount
equal to 300 percent of the percentage by which
the amount appropriated under section 1935(a)
for such fiscal year exceeds the amount
appropriated for the prior fiscal year.
(3) Decrease in or equal appropriations.--If the
amount appropriated under section 1935(a) for a fiscal
year is equal to or less than the amount appropriated
under such section for the prior fiscal year, the
amount of the State allotment under section 1921 shall
be equal to the amount that the State received under
section 1921 in the prior fiscal year decreased by the
percentage by which the amount appropriated for such
fiscal year is less than the amount appropriated or
such section for the prior fiscal year.
(c) Territories.--
(1) Determination under formula.--Subject to
paragraphs (2) and (4), the amount of an allotment
under section 1921 for a territory of the United States
for a fiscal year shall be the product of--
(A) an amount equal to the amounts reserved
under paragraph (3) for the fiscal year; and
(B) a percentage equal to the quotient of--
(i) the civilian population of the
territory, as indicated by the most
recently available data; divided by
(ii) the aggregate civilian
population of the territories of the
United States, as indicated by such
data.
(2) Minimum allotment for territories.--The amount of
an allotment under section 1921 for a territory of the
United States for a fiscal year shall be the greater
of--
(A) the amount determined under paragraph (1)
for the territory for the fiscal year;
(B) $50,000; and
(C) with respect to fiscal years 1993 and
1994, an amount equal to 79.4 percent of the
amount received by the territory from
allotments made pursuant to this part for
fiscal year 1992.
(3) Reservation of amounts.--The Secretary shall each
fiscal year reserve for the territories of the United
States 1.5 percent of the amounts appropriated under
section 1935(a) for allotments under section 1921 for
the fiscal year.
(4) Availability of data on population.--With respect
to data on the civilian population of the territories
of the United States, if the Secretary determines for a
fiscal year that recent such data for purposes of
paragraph (1)(B) do not exist regarding a territory,
the Secretary shall for such purposes estimate the
civilian population of the territory by modifying the
data on the territory to reflect the average extent of
change occurring during the ensuing period in the
population of all territories with respect to which
recent such data do exist.
(5) Applicability of certain provisions.--For
purposes of subsections (a) and (b), the term ``State''
does not include the territories of the United States.
(d) Indian tribes and tribal organizations.--
(1) In general.--If the Secretary--
(A) receives a request from the governing
body [of an Indian tribe or tribal
organization] of an Indian Tribe or Tribal
organization within any State that funds under
this subpart be provided directly by the
Secretary to [such tribe] such Tribe or
organization; and
(B) makes a determination that the members of
such [tribe or tribal organization] Tribe or
Tribal organization would be better served by
means of grants made directly by the [Secretary
under this] Secretary under this subpart;
the Secretary shall reserve from the allotment under
section 1921 for the State for the fiscal year involved
an amount that bears the same ratio to the allotment as
the amount provided under this subpart to the [tribe or
tribal organization] Tribe or Tribal organization for
fiscal year 1991 for activities relating to the
prevention and treatment of the [abuse of alcohol and
other drugs] use of substances bore to the amount of
the portion of the allotment under this subpart for the
State for such fiscal year that was expended for such
activities.
[(2) Tribe or tribal organization as grantee.--The
amount reserved by the Secretary on the basis of a
determination under this paragraph shall be granted to
the Indian tribe or tribal organization serving the
individuals for whom such a determination has been
made.]
(2) Indian tribe or tribal organization as grantee.--
The amount reserved by the Secretary on the basis of a
determination under this subsection shall be granted to
the Indian Tribe or Tribal organization serving the
individuals for whom such a determination has been
made.
(3) Application.--In order for an Indian [tribe or
tribal organization] Tribe or Tribal organization to be
eligible for a grant for a fiscal year under this
paragraph, it shall submit to the Secretary a plan for
such fiscal year that meets such criteria as the
Secretary may prescribe.
(4) [Definition] Definitions.--[The terms ``Indian
tribe'' and ``tribal organization'' have the same
meaning given such terms] The terms ``Indian Tribe''
and ``Tribal organization'' have the meanings given the
terms ``Indian tribe'' and ``tribal organization'' in
subsections (b) and (c) of section 4 of the Indian
Self-Determination and Education Assistance Act.
SEC. 1934. DEFINITIONS.
For purposes of this subpart:
(1) The term ``authorized activities'', subject to
section 1931, means the activities described in section
1921(b).
(2) The term ``funding agreement'', with respect to a
grant under section 1921 to a State, means that the
Secretary may make such a grant only if the State makes
the agreement involved.
(3) The term ``prevention activities'', subject to
section 1931, means activities to prevent substance use
disorders.
[(4) The term ``substance abuse'' means the abuse of
alcohol or other drugs.]
(4) The term ``substance use disorder'' means the
recurrent use of alcohol or other drugs that causes
clinically significant impairment.
(5) The term ``treatment activities'' means treatment
services and, subject to section 1931, authorized
activities that are related to treatment services.
(6) The term ``treatment facility'' means an entity
that provides treatment services.
(7) The term ``treatment services'', subject to
section 1931, means treatment for substance use
disorders.
SEC. 1935. FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this subpart, subpart III and section 505(d) with
respect to [substance abuse] substance use disorders, and
section 515(d), there are authorized to be [appropriated
$1,858,079,000 for each of fiscal years 2018 through 2022..]
appropriated $1,908,079,000 for each of fiscal years 2023
through 2027.
(b) Allocations for Technical Assistance, National Data Base,
Data Collection, and Program Evaluations.--
(1) In general.--
(A) For the purpose of carrying out section
1948(a) with respect to [substance abuse]
substance use disorders, section 515(d), and
the purposes specified in subparagraphs (B) and
(C), the Secretary shall obligate 5 percent of
the amounts appropriated under subsection (a)
each fiscal year.
(B) The purpose specified in this
subparagraph is [the collection of data in this
paragraph is] carrying out sections 505(d) and
1971 with respect to [substance abuse]
substance use disorders.
(C) The purpose specified in this
subparagraph is the conduct of evaluations of
authorized activities to determine methods for
improving the availability and quality of such
activities.
(2) Activities of center for substance abuse
prevention.--Of the amounts reserved under paragraph
(1) for a fiscal year, the Secretary, acting through
the Director of the Center for Substance Abuse
Prevention, shall obligate 20 percent for carrying out
paragraph (1)(C), section 1948(a) with respect to
prevention activities, and section 515(d).
(3) Core data set.--A State that receives a new
grant, contract, or cooperative agreement from amounts
available to the Secretary under paragraph (1), for the
purposes of improving the data collection, analysis and
reporting capabilities of the State, shall be required,
as a condition of receipt of funds, to collect,
analyze, and report to the Secretary for each fiscal
year subsequent to receiving such funds a core data set
to be determined by the Secretary in conjunction with
the States.
Subpart III--General Provisions
* * * * * * *
SEC. 1942. REQUIREMENT OF REPORTS AND AUDITS BY STATES.
(a) Report.--A funding agreement for a grant under section
1911 or 1921 is that the State involved will submit to the
Secretary a report in such form and containing such information
as the Secretary determines (after consultation with the
States) to be necessary for securing a record and a description
of--
(1) the purposes for which the grant received by the
State for the preceding fiscal year under the program
involved were expended and a description of the
activities of the State under the program; [and]
(2) the recipients of amounts provided in the
grant[.]; and
(3) the amount provided to each recipient in the
previous fiscal year.
(b) Audits.--A funding agreement for a grant under section
1911 or 1921 is that the State will, with respect to the grant,
comply with chapter 75 of title 31, United States Code.
(c) Availability to Public.--A funding agreement for a grant
under section 1911 or 1921 is that the State involved will--
(1) make copies of the reports and audits described
in this section available for public inspection within
the State; and
(2) provide copies of the report under subsection
(a), upon request, to any interested person (including
any public agency).
* * * * * * *
SEC. 1949. PLANS FOR PERFORMANCE PARTNERSHIPS.
(a) Development.--The Secretary in conjunction with States
and other interested groups shall develop separate plans for
the programs authorized under subparts I and II for creating
more flexibility for States and accountability based on outcome
and other performance measures. The plans shall each include--
(1) a description of the flexibility that would be
given to the States under the plan;
(2) the common set of performance measures that would
be used for accountability, including measures that
would be used for the program under subpart II for
pregnant addicts, HIV transmission, tuberculosis, and
those with a co-occurring [substance abuse] substance
use disorders and mental disorders, and for programs
under subpart I for children with serious emotional
disturbance and adults with serious mental illness and
for individuals with co-occurring mental health and
[substance abuse] substance use disorders disorders;
(3) the definitions for the data elements to be used
under the plan;
(4) the obstacles to implementation of the plan and
the manner in which such obstacles would be resolved;
(5) the resources needed to implement the performance
partnerships under the plan; and
(6) an implementation strategy complete with
recommendations for any necessary legislation.
(b) Submission.--Not later than 2 years after the date of the
enactment of this Act, the plans developed under subsection (a)
shall be submitted to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Commerce
of the House of Representatives.
(c) Information.--As the elements of the plans described in
subsection (a) are developed, States are encouraged to provide
information to the Secretary on a voluntary basis.
(d) Participants.--The Secretary shall include among those
interested groups that participate in the development of the
plan consumers of mental health or [substance abuse] substance
use disorders services, providers, representatives of political
divisions of States, and representatives of racial and ethnic
groups including Native Americans.
* * * * * * *
SEC. 1954. DEFINITIONS.
(a) Definitions for Subpart III.--For purposes of this
subpart:
(1) The term ``program involved'' means the program
of grants established in section 1911 or 1921, or both,
as indicated by whether the State involved is receiving
or is applying to receive a grant under section 1911 or
1921, or both.
(2)(A) The term ``funding agreement'', with respect
to a grant under section 1911, has the meaning given
such term in section 1919.
(B) The term ``funding agreement'', with respect to a
grant under section 1921, has the meaning given such
term in section 1934.
(b) Definitions for Part B.--For purposes of this part:
(1) The term ``Comptroller General'' means the
Comptroller General of the United States.
(2) The term ``State'', except as provided in
sections 1918(c)(5) and 1933(c)(5), means each of the
several States, the District of Columbia, and each of
the territories of the United States.
(3) The term ``territories of the United States''
means each of the Commonwealth of Puerto Rico, American
Samoa, Guam, the Commonwealth of the Northern Mariana
Islands, the Virgin Islands, Palau, the Marshall
Islands, and Micronesia.
(4) The term ``interim services'', in the case of an
individual in need of treatment for [substance abuse]
substance use disorders who has been denied admission
to a program of such treatment on the basis of the lack
of the capacity of the program to admit the individual,
means services for reducing the adverse health effects
of [such abuse] such disorders, for promoting the
health of the individual, and for reducing the risk of
transmission of disease, which services are provided
until the individual is admitted to such a program.
SEC. 1955. SERVICES PROVIDED BY NONGOVERNMENTAL ORGANIZATIONS.
(a) Purposes.--The purposes of this section are--
(1) to prohibit discrimination against
nongovernmental organizations and certain individuals
on the basis of religion in the distribution of
government funds to provide [substance abuse] substance
use disorder services under this title and title V, and
the receipt of services under such titles; and
(2) to allow the organizations to accept the funds to
provide the services to the individuals without
impairing the religious character of the organizations
or the religious freedom of the individuals.
(b) Religious Organizations Included as Nongovernmental
Providers.--
(1) In general.--A State may administer and provide
[substance abuse] substance use disorder services under
any program under this title or title V through grants,
contracts, or cooperative agreements to provide
assistance to beneficiaries under such titles with
nongovernmental organizations.
(2) Requirement.--A State that elects to utilize
nongovernmental organizations as provided for under
paragraph (1) shall consider, on the same basis as
other nongovernmental organizations, religious
organizations to provide services under [substance
abuse] substance use disorder programs under this title
or title V, so long as the programs under such titles
are implemented in a manner consistent with the
Establishment Clause of the first amendment to the
Constitution. Neither the Federal Government nor a
State or local government receiving funds under such
programs shall discriminate against an organization
that provides services under, or applies to provide
services under, such programs, on the basis that the
organization has a religious character.
(c) Religious Character and Independence.--
(1) In general.--A religious organization that
provides services under any [substance abuse] substance
use disorder program under this title or title V shall
retain its independence from Federal, State, and local
governments, including such organization's control over
the definition, development, practice, and expression
of its religious beliefs.
(2) Additional safeguards.--Neither the Federal
Government nor a State or local government shall
require a religious organization--
(A) to alter its form of internal governance;
or
(B) to remove religious art, icons,
scripture, or other symbols,
in order to be eligible to provide services under any
[substance abuse] substance use disorder program under
this title or title V.
(d) Employment Practices.--
(1) Substance abuse.--A religious organization that
provides services under any [substance abuse] substance
use disorder program under this title or title V may
require that its employees providing services under
such program adhere to rules forbidding the use of
drugs or alcohol.
(2) Title vii exemption.--The exemption of a
religious organization provided under section 702 or
703(e)(2) of the Civil Rights Act of 1964 (42 U.S.C.
2000e-1, 2000e-2(e)(2)) regarding employment practices
shall not be affected by the religious organization's
provision of services under, or receipt of funds from,
any [substance abuse] substance use disorder program
under this title or title V.
(e) Rights of Beneficiaries of Assistance.--
(1) In general.--If an individual described in
paragraph (3) has an objection to the religious
character of the organization from which the individual
receives, or would receive, services funded under any
[substance abuse] substance use disorder program under
this title or title V, the appropriate Federal, State,
or local governmental entity shall provide to such
individual (if otherwise eligible for such services)
within a reasonable period of time after the date of
such objection, services that--
(A) are from an alternative provider that is
accessible to the individual; and
(B) have a value that is not less than the
value of the services that the individual would
have received from such organization.
(2) Notice.--The appropriate Federal, State, or local
governmental entity shall ensure that notice is
provided to individuals described in paragraph (3) of
the rights of such individuals under this section.
(3) Individual described.--An individual described in
this paragraph is an individual who receives or applies
for services under any [substance abuse] substance use
disorder program under this title or title V.
(f) Nondiscrimination Against Beneficiaries.--A religious
organization providing services through a grant, contract, or
cooperative agreement under any [substance abuse] substance use
disorder program under this title or title V shall not
discriminate, in carrying out such program, against an
individual described in subsection (e)(3) on the basis of
religion, a religious belief, a refusal to hold a religious
belief, or a refusal to actively participate in a religious
practice.
(g) Fiscal Accountability.--
(1) In general.--Except as provided in paragraph (2),
any religious organization providing services under any
[substance abuse] substance use disorder program under
this title or title V shall be subject to the same
regulations as other nongovernmental organizations to
account in accord with generally accepted accounting
principles for the use of such funds provided under
such program.
(2) Limited audit.--Such organization shall segregate
government funds provided under such [substance abuse]
substance use disorder program into a separate account.
Only the government funds shall be subject to audit by
the government.
(h) Compliance.--Any party that seeks to enforce such party's
rights under this section may assert a civil action for
injunctive relief exclusively in an appropriate Federal or
State court against the entity, agency or official that
allegedly commits such violation.
(i) Limitations on Use of Funds for Certain Purposes.--No
funds provided through a grant or contract to a religious
organization to provide services under any [substance abuse]
substance use disorder program under this title or title V
shall be expended for sectarian worship, instruction, or
proselytization.
(j) Effect on State and Local Funds.--If a State or local
government contributes State or local funds to carry out any
[substance abuse] substance use disorder program under this
title or title V, the State or local government may segregate
the State or local funds from the Federal funds provided to
carry out the program or may commingle the State or local funds
with the Federal funds. If the State or local government
commingles the State or local funds, the provisions of this
section shall apply to the commingled funds in the same manner,
and to the same extent, as the provisions apply to the Federal
funds.
(k) Treatment of Intermediate Contractors.--If a
nongovernmental organization (referred to in this subsection as
an ``intermediate organization''), acting under a contract or
other agreement with the Federal Government or a State or local
government, is given the authority under the contract or
agreement to select nongovernmental organizations to provide
services under any [substance abuse] substance use disorder
program under this title or title V, the intermediate
organization shall have the same duties under this section as
the government but shall retain all other rights of a
nongovernmental organization under this section.
SEC. 1956. SERVICES FOR INDIVIDUALS WITH CO-OCCURRING DISORDERS.
States may use funds available for treatment under sections
1911 and 1921 to treat persons with co-occurring [substance
abuse] substance use disorders and mental disorders as long as
funds available under such sections are used for the purposes
for which they were authorized by law and can be tracked for
accounting purposes.
* * * * * * *
PART C--CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND [SUBSTANCE ABUSE]
SUBSTANCE USE
Subpart I--Data Infrastructure Development
SEC. 1971. DATA INFRASTRUCTURE DEVELOPMENT.
(a) In General.--The Secretary may make grants to, and enter
into contracts or cooperative agreements with States for the
purpose of developing and operating mental health or [substance
abuse] substance use data collection, analysis, and reporting
systems with regard to performance measures including capacity,
process, and outcomes measures.
(b) Projects.--The Secretary shall establish criteria to
ensure that services will be available under this section to
States that have a fundamental basis for the collection,
analysis, and reporting of mental health and [substance abuse]
substance use performance measures and States that do not have
such basis. The Secretary will establish criteria for
determining whether a State has a fundamental basis for the
collection, analysis, and reporting of data.
(c) Condition of Receipt of Funds.--As a condition of the
receipt of an award under this section a State shall agree to
collect, analyze, and report to the Secretary within 2 years of
the date of the award on a core set of performance measures to
be determined by the Secretary in conjunction with the States.
(d) Matching Requirement.--
(1) In general.--With respect to the costs of the
program to be carried out under subsection (a) by a
State, the Secretary may make an award under such
subsection only if the applicant agrees to make
available (directly or through donations from public or
private entities) non-Federal contributions toward such
costs in an amount that is not less than 50 percent of
such costs.
(2) Determination of amount contributed.--Non-Federal
contributions under paragraph (1) may be in cash or in
kind, fairly evaluated, including plant, equipment, or
services. Amounts provided by the Federal Government,
or services assisted or subsidized to any significant
extent by the Federal Government, may not be included
in determining the amount of such contributions.
(e) Duration of Support.--The period during which payments
may be made for a project under subsection (a) may be not less
than 3 years nor more than 5 years.
(f) Authorization of Appropriation.--
(1) In general.--For the purpose of carrying out this
section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
2001, 2002 and 2003.
(2) Allocation.--Of the amounts appropriated under
paragraph (1) for a fiscal year, 50 percent shall be
expended to support data infrastructure development for
mental health and 50 percent shall be expended to
support data infrastructure development for [substance
abuse] substance use.
Subpart II--Interim Maintenance Treatment of Narcotics Dependence
SEC. 1976. INTERIM MAINTENANCE TREATMENT.
(a) Requirement Regarding Secretary.--Subject to the
following subsections of this section, for the purpose of
reducing the incidence of the transmission of HIV disease
pursuant to the [intravenous abuse] intravenous use of heroin
or other morphine-like drugs, the Secretary, in establishing
conditions for the use of methadone in public or nonprofit
private programs of treatment for dependence on such drugs,
shall authorize such programs--
(1) to dispense methadone for treatment purposes to
individuals who--
(A) meet the conditions for admission to such
programs that dispense methadone as part of
comprehensive treatment for such dependence;
and
(B) are seeking admission to such programs
that so dispense methadone, but as a result of
the limited capacity of the programs, will not
gain such admission until 14 or more days after
seeking admission to the programs; and
(2) in dispensing methadone to such individuals, to
provide only minimum ancillary services during the
period in which the individuals are waiting for
admission to programs of comprehensive treatment.
(b) Inapplicability of Requirement in Certain
Circumstances.--
(1) In general.--The requirement established in
subsection (a) for the Secretary does not apply if any
or all of the following conditions are met:
(A) The preponderance of scientific research
indicates that the risk of the transmission of
HIV disease pursuant to the [intravenous abuse]
intravenous use of drugs is minimal.
(B) The preponderance of scientific research
indicates that the medically supervised
dispensing of methadone is not an effective
method of reducing the extent of dependence on
heroin and other morphine-like drugs.
(C) The preponderance of available data
indicates that, of treatment programs that
dispense methadone as part of comprehensive
treatment, a substantial majority admit all
individuals seeking services to the programs
not later than 14 days after the individuals
seek admission to the programs.
(2) Evaluation by secretary.--In evaluating whether
any or all of the conditions described in paragraph (1)
have been met, the Secretary shall consult with the
National Commission on Acquired Immune Deficiency
Syndrome.
(c) Conditions for Obtaining Authorization From Secretary.--
(1) In general.--In carrying out the requirement
established in subsection (a), the Secretary shall,
after consultation with the National Commission on
Acquired Immune Deficiency Syndrome, by regulation
issue such conditions for treatment programs to obtain
authorization from the Secretary to provide interim
maintenance treatment as may be necessary to carry out
the purpose described in such subsection. Such
conditions shall include conditions for preventing the
unauthorized use of methadone.
(2) Counseling on hiv disease.--The regulations
issued under paragraph (1) shall provide that an
authorization described in such paragraph may not be
issued to a treatment program unless the program
provides to recipients of the treatment counseling on
preventing exposure to and the transmission of HIV
disease.
(3) Permission of relevant state as condition of
authorization.--The regulations issued under paragraph
(1) shall provide that the Secretary may not provide an
authorization described in such paragraph to any
treatment program in a State unless the chief public
health officer of the State has certified to the
Secretary that--
(A) such officer does not object to the
provision of such authorizations to treatment
programs in the State; and
(B) the provision of interim maintenance
services in the State will not reduce the
capacity of comprehensive treatment programs in
the State to admit individuals to the programs
(relative to the date on which such officer so
certifies).
(4) Date certain for issuance of regulations; failure
of secretary.--The Secretary shall issue the final rule
for purposes of the regulations required in paragraph
(1), and such rule shall be effective, not later than
the expiration of the 180-day period beginning on the
date of the enactment of the ADAMHA Reorganization Act.
If the Secretary fails to meet the requirement of the
preceding sentence, the proposed rule issued on March
2, 1989, with respect to part 291 of title 21, Code of
Federal Regulations (docket numbered 88N-0444; 54 Fed.
Reg. 8973 et seq.) is deemed to take effect as a final
rule upon the expiration of such period, and the
provisions of paragraph (3) of this subsection are
deemed to be incorporated into such rule.
(d) Definitions.--For purposes of this section:
(1) The term ``interim maintenance services'' means
the provision of methadone in a treatment program under
the circumstances described in paragraphs (1) and (2)
of subsection (a).
(2) The term ``HIV disease'' means infection with the
etiologic agent for acquired immune deficiency
syndrome.
(3) The term ``treatment program'' means a public or
nonprofit private program of treatment for dependence
on heroin or other morphine-like drugs.
* * * * * * *
TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
PART A--INDIVIDUAL AND GROUP MARKET REFORMS
* * * * * * *
Subpart 2--Exclusion of Plans; Enforcement; Preemption
SEC. 2722. EXCLUSION OF CERTAIN PLANS.
(a) Limitation on Application of Provisions Relating to Group
Health Plans.--
(1) In general.--The requirements of subparts 1 and 2
and part D shall apply with respect to group health
plans only--
(A) subject to paragraph (2), in the case of
a plan that is a nonfederal governmental plan,
and
(B) with respect to health insurance coverage
offered in connection with a group health plan
(including such a plan that is a church plan or
a governmental plan).
(2) Treatment of nonfederal governmental plans.--
(A) Election to be excluded.--Except as
provided in subparagraph (D) or (E), if the
plan sponsor of a nonfederal governmental plan
which is a group health plan to which the
provisions of subparts 1 and 2 otherwise apply
makes an election under this subparagraph (in
such form and manner as the Secretary may by
regulations prescribe), then the requirements
of such subparts insofar as they apply directly
to group health plans (and not merely to group
health insurance coverage) shall not apply to
such governmental plans for such period except
as provided in this paragraph.
(B) Period of election.--An election under
subparagraph (A) shall apply--
(i) for a single specified plan year,
or
(ii) in the case of a plan provided
pursuant to a collective bargaining
agreement, for the term of such
agreement.
An election under clause (i) may be extended
through subsequent elections under this
paragraph.
(C) Notice to enrollees.--Under such an
election, the plan shall provide for--
(i) notice to enrollees (on an annual
basis and at the time of enrollment
under the plan) of the fact and
consequences of such election, and
(ii) certification and disclosure of
creditable coverage under the plan with
respect to enrollees in accordance with
section 2701(e).
(D) Election not applicable to requirements
concerning genetic information.--The election
described in subparagraph (A) shall not be
available with respect to the provisions of
subsections (a)(1)(F), (b)(3), (c), and (d) of
section 2702 and the provisions of sections
2701 and 2702(b) to the extent that such
provisions apply to genetic information.
(E) Election not applicable.--The election
described in subparagraph (A) shall not be
available with respect to the provisions of
subparts I and II.
(F) Sunset of election option.--
(i) In general.--Notwithstanding the
preceding provisions of this
paragraph--
(I) no election described in
subparagraph (A) with respect
to section 2726 may be made on
or after the date of the
enactment of this subparagraph;
and
(II) except as provided in
clause (ii), no such election
with respect to section 2726
expiring on or after the date
that is 180 days after the date
of such enactment may be
renewed.
(ii) Exception for certain
collectively bargained plans.--
Notwithstanding clause (i)(II), a plan
described in subparagraph (B)(ii) that
is subject to multiple agreements
described in such subparagraph of
varying lengths and that has an
election described in subparagraph (A)
with respect to section 2726 in effect
as of the date of the enactment of this
subparagraph that expires on or after
the date that is 180 days after the
date of such enactment may extend such
election until the date on which the
term of the last such agreement
expires.
(b) Exception for Certain Benefits.--The requirements of
subparts 1 and 2 and part Dshall not apply to any individual
coverage or any group health plan (or group health insurance
coverage) in relation to its provision of excepted benefits
described in section 2791(c)(1).
(c) Exception for Certain Benefits If Certain Conditions
Met.--
(1) Limited, excepted benefits.--The requirements of
subparts 1 and 2 and part Dshall not apply to any
individual coverage or any group health plan (and group
health insurance coverage offered in connection with a
group health plan) in relation to its provision of
excepted benefits described in section 2791(c)(2) if
the benefits--
(A) are provided under a separate policy,
certificate, or contract of insurance; or
(B) are otherwise not an integral part of the
plan.
(2) Noncoordinated, excepted benefits.--The
requirements of subparts 1 and 2 and part Dshall not
apply to any individual coverage or any group health
plan (and group health insurance coverage offered in
connection with a group health plan) in relation to its
provision of excepted benefits described in section
2791(c)(3) if all of the following conditions are met:
(A) The benefits are provided under a
separate policy, certificate, or contract of
insurance.
(B) There is no coordination between the
provision of such benefits and any exclusion of
benefits under any group health plan maintained
by the same plan sponsor.
(C) Such benefits are paid with respect to an
event without regard to whether benefits are
provided with respect to such an event under
any group health plan maintained by the same
plan sponsor or, with respect to individual
coverage, under any health insurance coverage
maintained by the same health insurance issuer.
(3) Supplemental excepted benefits.--The requirements
of this part and part Dshall not apply to any
individual coverage or any group health plan (and group
health insurance coverage) in relation to its provision
of excepted benefits described in section 27971(c)(4)
if the benefits are provided under a separate policy,
certificate, or contract of insurance.
(d) Treatment of Partnerships.--For purposes of this part and
part D--
(1) Treatment as a group health plan.--Any plan,
fund, or program which would not be (but for this
subsection) an employee welfare benefit plan and which
is established or maintained by a partnership, to the
extent that such plan, fund, or program provides
medical care (including items and services paid for as
medical care) to present or former partners in the
partnership or to their dependents (as defined under
the terms of the plan, fund, or program), directly or
through insurance, reimbursement, or otherwise, shall
be treated (subject to paragraph (2)) as an employee
welfare benefit plan which is a group health plan.
(2) Employer.--In the case of a group health plan,
the term ``employer'' also includes the partnership in
relation to any partner.
(3) Participants of group health plans.--In the case
of a group health plan, the term ``participant'' also
includes--
(A) in connection with a group health plan
maintained by a partnership, an individual who
is a partner in relation to the partnership, or
(B) in connection with a group health plan
maintained by a self-employed individual (under
which one or more employees are participants),
the self-employed individual,
if such individual is, or may become, eligible to
receive a benefit under the plan or such individual's
beneficiaries may be eligible to receive any such
benefit.
* * * * * * *
Part C--Definitions; Miscellaneous Provisions
* * * * * * *
SEC. 2794. ENSURING THAT CONSUMERS GET VALUE FOR THEIR DOLLARS.
(a) Initial Premium Review Process.--
(1) In general.--The Secretary, in conjunction with
States, shall establish a process for the annual
review, beginning with the 2010 plan year and subject
to subsection (b)(2)(A), of unreasonable increases in
premiums for health insurance coverage.
(2) Justification and disclosure.--The process
established under paragraph (1) shall require health
insurance issuers to submit to the Secretary and the
relevant State a justification for an unreasonable
premium increase prior to the implementation of the
increase. Such issuers shall prominently post such
information on their Internet websites. The Secretary
shall ensure the public disclosure of information on
such increases and justifications for all health
insurance issuers.
(b) Continuing Premium Review Process.--
(1) Informing secretary of premium increase
patterns.--As a condition of receiving a grant under
subsection (c)(1), a State, through its Commissioner of
Insurance, shall--
(A) provide the Secretary with information
about trends in premium increases in health
insurance coverage in premium rating areas in
the State; and
(B) make recommendations, as appropriate, to
the State Exchange about whether particular
health insurance issuers should be excluded
from participation in the Exchange based on a
pattern or practice of excessive or unjustified
premium increases.
(2) Monitoring by secretary of premium increases.--
(A) In general.--Beginning with plan years
beginning in 2014, the Secretary, in
conjunction with the States and consistent with
the provisions of subsection (a)(2), shall
monitor premium increases of health insurance
coverage offered through an Exchange and
outside of an Exchange.
(B) Consideration in opening exchange.--In
determining under section 1312(f)(2)(B) of the
Patient Protection and Affordable Care Act
whether to offer qualified health plans in the
large group market through an Exchange, the
State shall take into account any excess of
premium growth outside of the Exchange as
compared to the rate of such growth inside the
Exchange.
(c) Grants in Support of Process.--
(1) Premium review grants during 2010 through 2014.--
The Secretary shall carry out a program to award grants
to States during the 5-year period beginning with
fiscal year 2010 to assist such States in carrying out
subsection (a), including--
(A) in reviewing and, if appropriate under
State law, approving premium increases for
health insurance coverage;
(B) in providing information and
recommendations to the Secretary under
subsection (b)(1); and
(C) in establishing centers (consistent with
subsection (d)) at academic or other nonprofit
institutions to collect medical reimbursement
information from health insurance issuers, to
analyze and organize such information, and to
make such information available to such
issuers, health care providers, health
researchers, health care policy makers, and the
general public.
(2) Funding.--
(A) In general.--Out of all funds in the
Treasury not otherwise appropriated, there are
appropriated to the Secretary $250,000,000, to
be available for expenditure for grants under
paragraph (1) and subparagraph (B).
(B) Further availability for insurance reform
and consumer protection.--If the amounts
appropriated under subparagraph (A) are not
fully obligated under grants under paragraph
(1) by the end of fiscal year 2014, any
remaining funds shall remain available to the
Secretary for grants to States for planning and
implementing the insurance reforms and consumer
protections under part A.
(C) Allocation.--The Secretary shall
establish a formula for determining the amount
of any grant to a State under this subsection.
Under such formula--
(i) the Secretary shall consider the
number of plans of health insurance
coverage offered in each State and the
population of the State; and
(ii) no State qualifying for a grant
under paragraph (1) shall receive less
than $1,000,000, or more than
$5,000,000 for a grant year.
(3) Parity implementation.--
(A) In general.--Beginning during the first
fiscal year that begins after the date of
enactment of this paragraph, the Secretary
shall, out of funds made available pursuant to
subparagraph (C), award grants to eligible
States to enforce and ensure compliance with
the mental health and substance use disorder
parity provisions of section 2726.
(B) Eligible state.--A State shall be
eligible for a grant awarded under this
paragraph only if such State--
(i) submits to the Secretary an
application for such grant at such
time, in such manner, and containing
such information as specified by the
Secretary; and
(ii) agrees to request and review
from health insurance issuers offering
group or individual health insurance
coverage the comparative analyses and
other information required of such
health insurance issuers under
subsection (a)(8)(A) of section 2726
relating to the design and application
of nonquantitative treatment
limitations imposed on mental health or
substance use disorder benefits.
(C) Authorization of appropriations.--There
are authorized to be appropriated $10,000,000
for each of the first five fiscal years
beginning after the date of the enactment of
this paragraph, to remain available until
expended, for purposes of awarding grants under
subparagraph (A).
(d) Medical Reimbursement Data Centers.--
(1) Functions.--A center established under subsection
(c)(1)(C) shall--
(A) develop fee schedules and other database
tools that fairly and accurately reflect market
rates for medical services and the geographic
differences in those rates;
(B) use the best available statistical
methods and data processing technology to
develop such fee schedules and other database
tools;
(C) regularly update such fee schedules and
other database tools to reflect changes in
charges for medical services;
(D) make health care cost information readily
available to the public through an Internet
website that allows consumers to understand the
amounts that health care providers in their
area charge for particular medical services;
and
(E) regularly publish information concerning
the statistical methodologies used by the
center to analyze health charge data and make
such data available to researchers and policy
makers.
(2) Conflicts of interest.--A center established
under subsection (c)(1)(C) shall adopt by-laws that
ensures that the center (and all members of the
governing board of the center) is independent and free
from all conflicts of interest. Such by-laws shall
ensure that the center is not controlled or influenced
by, and does not have any corporate relation to, any
individual or entity that may make or receive payments
for health care services based on the center's analysis
of health care costs.
(3) Rule of construction.--Nothing in this subsection
shall be construed to permit a center established under
subsection (c)(1)(C) to compel health insurance issuers
to provide data to the center.
SEC. 2794. UNIFORM FRAUD AND ABUSE REFERRAL FORMAT.
The Secretary shall request the National Association of
Insurance Commissioners to develop a model uniform report form
for private health insurance issuer seeking to refer suspected
fraud and abuse to State insurance departments or other
responsible State agencies for investigation. The Secretary
shall request that the National Association of Insurance
Commissioners develop recommendations for uniform reporting
standards for such referrals.
* * * * * * *
----------
HELPING FAMILIES IN MENTAL HEALTH CRISIS REFORM ACT OF 2016
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st Century
Cures Act''.
(b) Table of Contents.--The table of contents for this Act is
as follows:
Sec. 1. Short title; table of contents.
* * * * * * *
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
Sec. 6000. Short title.
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
* * * * * * *
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
[Sec. 6031. Interdepartmental Serious Mental Illness Coordinating
Committee.]
* * * * * * *
DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS
* * * * * * *
TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
* * * * * * *
Subtitle C--Interdepartmental Serious Mental Illness Coordinating
Committee
[SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS COORDINATING
COMMITTEE.
[(a) Establishment.--
[(1) In general.--Not later than 3 months after the
date of enactment of this Act, the Secretary of Health
and Human Services, or the designee of the Secretary,
shall establish a committee to be known as the
Interdepartmental Serious Mental Illness Coordinating
Committee (in this section referred to as the
``Committee'').
[(2) Federal advisory committee act.--Except as
provided in this section, the provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall apply to
the Committee.
[(b) Meetings.--The Committee shall meet not fewer than 2
times each year.
[(c) Responsibilities.--Not later than 1 year after the date
of enactment of this Act, and 5 years after such date of
enactment, the Committee shall submit to Congress and any other
relevant Federal department or agency a report including--
[(1) a summary of advances in serious mental illness
and serious emotional disturbance research related to
the prevention of, diagnosis of, intervention in, and
treatment and recovery of serious mental illnesses,
serious emotional disturbances, and advances in access
to services and support for adults with a serious
mental illness or children with a serious emotional
disturbance;
[(2) an evaluation of the effect Federal programs
related to serious mental illness have on public
health, including public health outcomes such as--
[(A) rates of suicide, suicide attempts,
incidence and prevalence of serious mental
illnesses, serious emotional disturbances, and
substance use disorders, overdose, overdose
deaths, emergency hospitalizations, emergency
room boarding, preventable emergency room
visits, interaction with the criminal justice
system, homelessness, and unemployment;
[(B) increased rates of employment and
enrollment in educational and vocational
programs;
[(C) quality of mental and substance use
disorders treatment services; or
[(D) any other criteria as may be determined
by the Secretary; and
[(3) specific recommendations for actions that
agencies can take to better coordinate the
administration of mental health services for adults
with a serious mental illness or children with a
serious emotional disturbance.
[(d) Committee Extension.--Upon the submission of the second
report under subsection (c), the Secretary shall submit a
recommendation to Congress on whether to extend the operation
of the Committee.
[(e) Membership.--
[(1) Federal members.--The Committee shall be
composed of the following Federal representatives, or
the designees of such representatives--
[(A) the Secretary of Health and Human
Services, who shall serve as the Chair of the
Committee;
[(B) the Assistant Secretary for Mental
Health and Substance Use;
[(C) the Attorney General;
[(D) the Secretary of Veterans Affairs;
[(E) the Secretary of Defense;
[(F) the Secretary of Housing and Urban
Development;
[(G) the Secretary of Education;
[(H) the Secretary of Labor;
[(I) the Administrator of the Centers for
Medicare & Medicaid Services; and
[(J) the Commissioner of Social Security.
[(2) Non-federal members.--The Committee shall also
include not less than 14 non-Federal public members
appointed by the Secretary of Health and Human
Services, of which--
[(A) at least 2 members shall be an
individual who has received treatment for a
diagnosis of a serious mental illness;
[(B) at least 1 member shall be a parent or
legal guardian of an adult with a history of a
serious mental illness or a child with a
history of a serious emotional disturbance;
[(C) at least 1 member shall be a
representative of a leading research, advocacy,
or service organization for adults with a
serious mental illness;
[(D) at least 2 members shall be--
[(i) a licensed psychiatrist with
experience in treating serious mental
illnesses;
[(ii) a licensed psychologist with
experience in treating serious mental
illnesses or serious emotional
disturbances;
[(iii) a licensed clinical social
worker with experience treating serious
mental illnesses or serious emotional
disturbances; or
[(iv) a licensed psychiatric nurse,
nurse practitioner, or physician
assistant with experience in treating
serious mental illnesses or serious
emotional disturbances;
[(E) at least 1 member shall be a licensed
mental health professional with a specialty in
treating children and adolescents with a
serious emotional disturbance;
[(F) at least 1 member shall be a mental
health professional who has research or
clinical mental health experience in working
with minorities;
[(G) at least 1 member shall be a mental
health professional who has research or
clinical mental health experience in working
with medically underserved populations;
[(H) at least 1 member shall be a State
certified mental health peer support
specialist;
[(I) at least 1 member shall be a judge with
experience in adjudicating cases related to
criminal justice or serious mental illness;
[(J) at least 1 member shall be a law
enforcement officer or corrections officer with
extensive experience in interfacing with adults
with a serious mental illness, children with a
serious emotional disturbance, or individuals
in a mental health crisis; and
[(K) at least 1 member shall have experience
providing services for homeless individuals and
working with adults with a serious mental
illness, children with a serious emotional
disturbance, or individuals in a mental health
crisis.
[(3) Terms.--A member of the Committee appointed
under subsection (e)(2) shall serve for a term of 3
years, and may be reappointed for 1 or more additional
3-year terms. Any member appointed to fill a vacancy
for an unexpired term shall be appointed for the
remainder of such term. A member may serve after the
expiration of the member's term until a successor has
been appointed.
[(f) Working Groups.--In carrying out its functions, the
Committee may establish working groups. Such working groups
shall be composed of Committee members, or their designees, and
may hold such meetings as are necessary.
[(g) Sunset.--The Committee shall terminate on the date that
is 6 years after the date on which the Committee is established
under subsection (a)(1).]
* * * * * * *
----------
PROTECTING ACCESS TO MEDICARE ACT OF 2014
* * * * * * *
TITLE II--OTHER HEALTH PROVISIONS
* * * * * * *
[SEC. 224. ASSISTED OUTPATIENT TREATMENT GRANT PROGRAM FOR INDIVIDUALS
WITH SERIOUS MENTAL ILLNESS.
[(a) In general.--The Secretary shall establish a 4-year
pilot program to award not more than 50 grants each year to
eligible entities for assisted outpatient treatment programs
for individuals with serious mental illness.
[(b) Consultation.--The Secretary shall carry out this
section in consultation with the Director of the National
Institute of Mental Health, the Attorney General of the United
States, the Administrator of the Administration for Community
Living, and the Administrator of the Substance Abuse and Mental
Health Services Administration.
[(c) Selecting Among Applicants.--The Secretary--
[(1) may only award grants under this section to
applicants that have not previously implemented an
assisted outpatient treatment program; and
[(2) shall evaluate applicants based on their
potential to reduce hospitalization, homelessness,
incarceration, and interaction with the criminal
justice system while improving the health and social
outcomes of the patient.
[(d) Use of Grant.--An assisted outpatient treatment program
funded with a grant awarded under this section shall include--
[(1) evaluating the medical and social needs of the
patients who are participating in the program;
[(2) preparing and executing treatment plans for such
patients that--
[(A) include criteria for completion of
court-ordered treatment; and
[(B) provide for monitoring of the patient's
compliance with the treatment plan, including
compliance with medication and other treatment
regimens;
[(3) providing for such patients case management
services that support the treatment plan;
[(4) ensuring appropriate referrals to medical and
social service providers;
[(5) evaluating the process for implementing the
program to ensure consistency with the patient's needs
and State law; and
[(6) measuring treatment outcomes, including health
and social outcomes such as rates of incarceration,
health care utilization, and homelessness.
[(e) Report.--Not later than the end of each of fiscal years
2016, 2017, 2018, 2019, 2020, 2021, and 2022, the Secretary
shall submit a report to the appropriate congressional
committees on the grant program under this section. Each such
report shall include an evaluation of the following:
[(1) Cost savings and public health outcomes such as
mortality, suicide, substance abuse, hospitalization,
and use of services.
[(2) Rates of incarceration by patients.
[(3) Rates of homelessness among patients.
[(4) Patient and family satisfaction with program
participation.
[(f) Definitions.--In this section:
[(1) The term ``assisted outpatient treatment'' means
medically prescribed mental health treatment that a
patient receives while living in a community under the
terms of a law authorizing a State or local court to
order such treatment.
[(2) The term ``eligible entity'' means a county,
city, mental health system, mental health court, or any
other entity with authority under the law of the State
in which the grantee is located to implement, monitor,
and oversee assisted outpatient treatment programs.
[(3) The term ``Secretary'' means the Secretary of
Health and Human Services.
[(g) Funding.--
[(1) Amount of grants.--A grant under this section
shall be in an amount that is not more than $1,000,000
for each of fiscal years 2015 through 2022. Subject to
the preceding sentence, the Secretary shall determine
the amount of each grant based on the population of the
area, including estimated patients, to be served under
the grant.
[(2) Authorization of appropriations.--There are
authorized to be appropriated to carry out this section
$15,000,000 for each of fiscal years 2015 through 2017,
$20,000,000 for fiscal year 2018, $19,000,000 for each
of fiscal years 2019 and 2020, and $18,000,000 for each
of fiscal years 2021 and 2022.]
SEC. 224. ASSISTED OUTPATIENT TREATMENT GRANT PROGRAM FOR INDIVIDUALS
WITH SERIOUS MENTAL ILLNESS.
(a) In General.--The Secretary shall carry out a program to
award grants to eligible entities for assisted outpatient
treatment programs for individuals with serious mental illness.
(b) Consultation.--The Secretary shall carry out this section
in consultation with the Director of the National Institute of
Mental Health, the Attorney General of the United States, the
Administrator of the Administration for Community Living, and
the Assistant Secretary for Mental Health and Substance Use.
(c) Selecting Among Applicants.--In awarding grants under
this section, the Secretary--
(1) may give preference to applicants that have not
previously implemented an assisted outpatient treatment
program; and
(2) shall evaluate applicants based on their
potential to reduce hospitalization, homelessness,
incarceration, and interaction with the criminal
justice system while improving the health and social
outcomes of the patient.
(d) Program Requirements.--An assisted outpatient treatment
program funded with a grant awarded under this section shall
include--
(1) evaluating the medical and social needs of the
patients who are participating in the program;
(2) preparing and executing treatment plans for such
patients that--
(A) include criteria for completion of court-
ordered treatment if applicable; and
(B) provide for monitoring of the patient's
compliance with the treatment plan, including
compliance with medication and other treatment
regimens;
(3) providing for case management services that
support the treatment plan;
(4) ensuring appropriate referrals to medical and
social services providers;
(5) evaluating the process for implementing the
program to ensure consistency with the patient's needs
and State law; and
(6) measuring treatment outcomes, including health
and social outcomes such as rates of incarceration,
health care utilization, and homelessness.
(e) Report.--Not later than the end of fiscal year 2027, the
Secretary shall submit a report to the appropriate
congressional committees on the grant program under this
section. Such report shall include an evaluation of the
following:
(1) Cost savings and public health outcomes such as
mortality, suicide, substance abuse, hospitalization,
and use of services.
(2) Rates of incarceration of patients.
(3) Rates of homelessness of patients.
(4) Patient and family satisfaction with program
participation.
(5) Demographic information regarding participation
of those served by the grant compared to demographic
information in the population of the grant recipient.
(f) Definitions.--In this section:
(1) The term ``assisted outpatient treatment'' means
medically prescribed mental health treatment that a
patient receives while living in a community under the
terms of a law authorizing a State or local civil court
to order such treatment.
(2) The term ``eligible entity'' means a county,
city, mental health system, mental health court, or any
other entity with authority under the law of the State
in which the entity is located to implement, monitor,
and oversee an assisted outpatient treatment program.
(g) Funding.--
(1) Amount of grants.--
(A) Maximum amount.--The amount of a grant
under this section shall not exceed $1,000,000
for any fiscal year.
(B) Determination.--Subject to subparagraph
(A), the Secretary shall determine the amount
of each grant under this section based on the
population of the area to be served through the
grant and an estimate of the number of patients
to be served.
(2) Authorization of appropriations.--There is
authorized to be appropriated to carry out this section
$22,000,000 for each of fiscal years 2023 through 2027.
* * * * * * *
----------
COMPREHENSIVE ADDICTION AND RECOVERY ACT OF 2016
* * * * * * *
TITLE I--PREVENTION AND EDUCATION
* * * * * * *
SEC. 107. IMPROVING ACCESS TO OVERDOSE TREATMENT.
(a) Grants for Reducing Overdose Deaths.--[Omitted Amends
other Act]''.
[(b) Improving Access to Overdose Treatment.--
[(1) Information on best practices.--Not later than
180 days after the date of enactment of this Act:
[(A) The Secretary of Health and Human
Services may provide information to prescribers
within Federally qualified health centers (as
defined in paragraph (4) of section 1861(aa) of
the Social Security Act (42 U.S.C. 1395x(aa))),
and the health care facilities of the Indian
Health Service, on best practices for
prescribing or co-prescribing a drug or device
approved or cleared under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
for emergency treatment of known or suspected
opioid overdose, including for patients
receiving chronic opioid therapy and patients
being treated for opioid use disorders.
[(B) The Secretary of Defense may provide
information to prescribers within Department of
Defense medical facilities on best practices
for prescribing or co-prescribing a drug or
device approved or cleared under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) for emergency treatment of known or
suspected opioid overdose, including for
patients receiving chronic opioid therapy and
patients being treated for opioid use
disorders.
[(C) The Secretary of Veterans Affairs may
provide information to prescribers within
Department of Veterans Affairs medical
facilities on best practices for prescribing or
co-prescribing a drug or device approved or
cleared under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) for
emergency treatment of known or suspected
opioid overdose, including for patients
receiving chronic opioid therapy and patients
being treated for opioid use disorders.
[(2) Rule of construction.--Nothing in this
subsection should be construed to establish or
contribute to a medical standard of care.]
* * * * * * *
----------
SUPPORT FOR PATIENTS AND COMMUNITIES ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Substance
Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act'' or the ``SUPPORT
for Patients and Communities Act''.
(b) Table of Contents.--The table of contents of this Act is
as follows:
Sec. 1. Short title; table of contents.
* * * * * * *
Subtitle J--Alternatives to Opioids in the Emergency Department
Sec. 7091. Emergency department alternatives to opioids [demonstration]
program.
* * * * * * *
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle J--Alternatives to Opioids in the Emergency Department
SEC. 7091. EMERGENCY DEPARTMENT ALTERNATIVES TO OPIOIDS [DEMONSTRATION]
PROGRAM.
(a) [Demonstration Program Grants.--] Grant Program._
(1) In general.--The Secretary of Health and Human
Services (in this section referred to as the
``Secretary'') shall carry out a [demonstration]
program for purposes of awarding grants to hospitals
and emergency departments, including freestanding
emergency departments, to develop, implement, enhance,
or study alternatives to opioids for pain management in
such settings.
(2) Eligibility.--To be eligible to receive a grant
under paragraph (1), a hospital or emergency department
shall submit an application to the Secretary at such
time, in such manner, and containing such information
as the Secretary may require.
(3) Geographic distribution.--In awarding grants
under this section, the Secretary shall seek to ensure
geographical distribution among grant recipients.
(4) Use of funds.--Grants under paragraph (1) shall
be used to--
(A) target treatment approaches for painful
conditions frequently treated in such settings;
(B) train providers and other hospital
personnel on protocols or best practices
related to the use and prescription of opioids
and alternatives to opioids for pain management
in the emergency department; and
(C) develop or continue strategies to provide
alternatives to opioids, as appropriate.
(b) Additional [Demonstration] Program.--The Secretary may
carry out a demonstration program similar to the program under
subsection (a) for other acute care settings.
(c) Consultation.--The Secretary shall implement a process
for recipients of grants under subsection (a) or (b) to share
evidence-based and best practices and promote consultation with
persons having robust knowledge, including emergency
departments and physicians that have successfully implemented
programs that use alternatives to opioids for pain management,
as appropriate, such as approaches studied through the National
Center for Complimentary and Integrative Health or other
institutes and centers at the National Institutes of Health, as
appropriate. The Secretary shall offer to each recipient of a
grant under subsection (a) or (b) technical assistance as
necessary.
(d) Technical Assistance.--The Secretary shall identify or
facilitate the development of best practices on alternatives to
opioids for pain management and provide technical assistance to
hospitals and other acute care settings on alternatives to
opioids for pain management. The technical assistance provided
shall be for the purpose of--
(1) utilizing information from recipients of a grant
under subsection (a) or (b) that have successfully
implemented alternatives to opioids programs;
(2) identifying or facilitating the development of
best practices on the use of alternatives to opioids,
which may include pain-management strategies that
involve non-addictive medical products, non-
pharmacologic treatments, and technologies or
techniques to identify patients at risk for opioid use
disorder;
(3) identifying or facilitating the development of
best practices on the use of alternatives to opioids
that target common painful conditions and include
certain patient populations, such as geriatric
patients, pregnant women, and children; and
(4) disseminating information on the use of
alternatives to opioids to providers in acute care
settings, which may include emergency departments,
outpatient clinics, critical access hospitals,
Federally qualified health centers, Indian Health
Service health facilities, and [tribal] Tribal
hospitals.
(e) Report to the Secretary.--Each recipient of a grant under
this section shall submit to the Secretary (during the period
of such grant) annual reports on the progress of the program
funded through the grant. These reports shall include, in
accordance with all applicable State and Federal privacy laws--
(1) a description of and specific information about
the opioid alternative pain management programs,
including the demographic characteristics of patients
who were treated with an alternative pain management
protocol, implemented in hospitals, emergency
departments, and other acute care settings;
(2) data on the opioid alternative pain management
strategies used, including the number of opioid
prescriptions written--
(A) during a baseline period before the
program began; or
(B) at various stages of the program; and
(3) data on patients who were eventually prescribed
opioids after alternative pain management protocols and
treatments were utilized; and
(4) any other information the Secretary determines
appropriate.
(f) Report to Congress.--[Not later than 1 year after
completion of the demonstration program under this section, the
Secretary shall submit a report to the Congress on the results
of the demonstration program] Not later than the end of each of
fiscal years 2024 and 2027, the Secretary shall submit to the
Congress a report on the results of the program and include in
the report--
(1) the number of applications received and the
number funded;
(2) a summary of the reports described in subsection
(e), including data that allows for comparison of
programs; and
(3) recommendations for broader implementation of
pain management strategies that encourage the use of
alternatives to opioids in hospitals, emergency
departments, or other acute care settings.
(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $10,000,000 for
each of fiscal years [2019 through 2021] 2023 through 2027.
* * * * * * *
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CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
persons required to register
Sec. 302. (a)(1) Every person who manufactures or distributes
any controlled substance or list I chemical, or who proposes to
engage in the manufacture or distribution of any controlled
substance or list I chemical, shall obtain annually a
registration issued by the Attorney General in accordance with
the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense,
any controlled substance, shall obtain from the Attorney
General a registration issued in accordance with the rules and
regulations promulgated by him. The Attorney General shall, by
regulation, determine the period of such registrations. In no
event; however, shall such registrations be issued for less
than one year nor for more than three years.
(3)(A) Except as provided in subparagraph (C), the
registration of any registrant under this title to manufacture,
distribute, or dispense controlled substances or list I
chemicals terminates if and when such registrant--
(i) dies;
(ii) ceases legal existence;
(iii) discontinues business or professional practice;
or
(iv) surrenders such registration.
(B) In the case of such a registrant who ceases legal
existence or discontinues business or professional practice,
such registrant shall promptly notify the Attorney General in
writing of such fact.
(C) No registration under this title to manufacture,
distribute, or dispense controlled substances or list I
chemicals, and no authority conferred thereby, may be assigned
or otherwise transferred except upon such conditions as the
Attorney General may specify and then only pursuant to written
consent. A registrant to whom a registration is assigned or
transferred pursuant to the preceding sentence may not
manufacture, distribute, or dispense controlled substances or
list I chemicals pursuant to such registration until the
Attorney General receives such written consent.
(D) In the case of a registrant under this title to
manufacture, distribute, or dispense controlled substances or
list I chemicals desiring to discontinue business or
professional practice altogether or with respect to controlled
substances and list I chemicals (without assigning or
transferring such business or professional practice to another
entity), such registrant shall return to the Attorney General
for cancellation--
(i) the registrant's certificate of registration;
(ii) any unexecuted order forms in the registrant's
possession; and
(iii) any other documentation that the Attorney
General may require.
(b) Persons registered by the Attorney General under this
title to manufacture, distribute, or dispense controlled
substances or list I chemicals are authorized to possess,
manufacture, distribute, or dispense such substances or
chemicals (including any such activity in the conduct of
research) to the extent authorized by their registration and in
conformity with the other provisions of this title.
(c) The following persons shall not be required to register
and may lawfully possess any controlled substance or list I
chemical under this title:
(1) An agent or employee of any registered
manufacturer, distributor, or dispenser of any
controlled substance or list I chemical if such agent
or employee is acting in the usual course of his
business or employment.
(2) A common or contract carrier or warehouseman, or
an employee thereof, whose possession of the controlled
substance or list I chemical is in the usual course of
his business or employment.
(3) An ultimate user who possesses such substance for
a purpose specified in section 102(25).
(d) The Attorney General may, by regulation, waive the
requirement for registration of certain manufacturers,
distributors, or dispensers if he finds it consistent with the
public health and safety.
(e)(1) A separate registration shall be required at each
principal place of business or professional practice where the
applicant manufactures, distributes, or dispenses controlled
substances or list I chemicals.
(2) Notwithstanding paragraph (1), a registrant who is a
veterinarian shall not be required to have a separate
registration in order to transport and dispense controlled
substances in the usual course of veterinary practice at a site
other than the registrant's registered principal place of
business or professional practice, so long as the site of
transporting and dispensing is located in a State where the
veterinarian is licensed to practice veterinary medicine and is
not a principal place of business or professional practice.
(3) Notwithstanding paragraph (1), a registrant that is
dispensing pursuant to section 303(g) narcotic drugs to
individuals for maintenance treatment or detoxification
treatment shall not be required to have a separate registration
to incorporate one or more mobile medication units into the
registrant's practice to dispense such narcotics at locations
other than the registrant's principal place of business or
professional practice described in paragraph (1), so long as
the registrant meets such standards for operation of a mobile
medication unit as the Attorney General may establish.
(f) The Attorney General is authorized to inspect the
establishment of a registrant or applicant for registration in
accordance with the rules and regulations promulgated by him.
(g)(1) An ultimate user who has lawfully obtained a
controlled substance in accordance with this title may, without
being registered, deliver the controlled substance to another
person for the purpose of disposal of the controlled substance
if--
(A) the person receiving the controlled substance is
authorized under this title to engage in such activity;
and
(B) the disposal takes place in accordance with
regulations issued by the Attorney General to prevent
diversion of controlled substances.
(2) In developing regulations under this subsection, the
Attorney General shall take into consideration the public
health and safety, as well as the ease and cost of program
implementation and participation by various communities. Such
regulations may not require any entity to establish or operate
a delivery or disposal program.
(3) The Attorney General may, by regulation, authorize long-
term care facilities, as defined by the Attorney General by
regulation, to dispose of controlled substances on behalf of
ultimate users who reside, or have resided, at such long-term
care facilities in a manner that the Attorney General
determines will provide effective controls against diversion
and be consistent with the public health and safety.
(4) If a person dies while lawfully in possession of a
controlled substance for personal use, any person lawfully
entitled to dispose of the decedent's property may deliver the
controlled substance to another person for the purpose of
disposal under the same conditions as provided in paragraph (1)
for an ultimate user.
(5)(A) In the case of a person receiving hospice care, an
employee of a qualified hospice program, acting within the
scope of employment, may handle, without being registered under
this section, any controlled substance that was lawfully
dispensed to the person receiving hospice care, for the purpose
of disposal of the controlled substance so long as such
disposal occurs onsite in accordance with all applicable
Federal, State, Tribal, and local law and--
(i) the disposal occurs after the death of a person
receiving hospice care;
(ii) the controlled substance is expired; or
(iii)(I) the employee is--
(aa) the physician of the person
receiving hospice care; and
(bb) registered under section 303(f);
and
(II) the hospice patient no longer requires
the controlled substance because the plan of
care of the hospice patient has been modified.
(B) For the purposes of this paragraph:
(i) The terms ``hospice care'' and ``hospice
program'' have the meanings given to those terms in
section 1861(dd) of the Social Security Act.
(ii) The term ``employee of a qualified hospice
program'' means a physician, physician assistant,
nurse, or other person who--
(I) is employed by, or pursuant to
arrangements made by, a qualified hospice
program;
(II)(aa) is licensed to perform medical or
nursing services by the jurisdiction in which
the person receiving hospice care was located;
and
(bb) is acting within the scope of such
employment in accordance with applicable State
law; and
(III) has completed training through the
qualified hospice program regarding the
disposal of controlled substances in a secure
and responsible manner so as to discourage
abuse, misuse, or diversion.
(iii) The term ``qualified hospice program'' means a
hospice program that--
(I) has written policies and procedures for
assisting in the disposal of the controlled
substances of a person receiving hospice care
after the person's death;
(II) at the time when the controlled
substances are first ordered--
(aa) provides a copy of the written
policies and procedures to the patient
or patient representative and family;
(bb) discusses the policies and
procedures with the patient or
representative and the family in a
language and manner that they
understand to ensure that these parties
are educated regarding the safe
disposal of controlled substances; and
(cc) documents in the patient's
clinical record that the written
policies and procedures were provided
and discussed; and
(III) at the time following the disposal of
the controlled substances--
(aa) documents in the patient's
clinical record the type of controlled
substance, dosage, route of
administration, and quantity so
disposed; and
(bb) the time, date, and manner in
which that disposal occurred.
registration requirements
Sec. 303. (a) The Attorney General shall register an
applicant to manufacture controlled substances in schedule I or
II if he determines that such registration is consistent with
the public interest and with United States obligations under
international treaties, conventions, or protocols in effect on
the effective date of this part. In determining the public
interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances and any
controlled substance in schedule I or II compounded
therefrom into other than legitimate medical,
scientific, research, or industrial channels, by
limiting the importation and bulk manufacture of such
controlled substances to a number of establishments
which can produce an adequate and uninterrupted supply
of these substances under adequately competitive
conditions for legitimate medical, scientific,
research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of
manufacturing these substances and the development of
new substances;
(4) prior conviction record of applicant under
Federal and State laws relating to the manufacture,
distribution, or dispensing of such substances;
(5) past experience in the manufacture of controlled
substances, and the existence in the establishment of
effective control against diversion; and
(6) such other factors as may be relevant to and
consistent with the public health and safety.
(b) The Attorney General shall register an applicant to
distribute a controlled substance in schedule I or II unless he
determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances into
other than legitimate medical, scientific, and
industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and
consistent with the public health and safety.
(c) Registration granted under subsections (a) and (b) of
this section shall not entitle a registrant to (1) manufacture
or distribute controlled substances in schedule I or II other
than those specified in the registration, or (2) manufacture
any quantity of those controlled substances in excess of the
quota assigned pursuant to section 306.
(d) The Attorney General shall register an applicant to
manufacture controlled substances in schedule III, IV, or V,
unless he determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances and any
controlled substance in schedule III, IV, or V
compounded therefrom into other than legitimate
medical, scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of
manufacturing these substances and the development of
new substances;
(4) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(5) past experience in the manufacture, distribution,
and dispensing of controlled substances, and the
existence in the establishment of effective controls
against diversion; and
(6) such other factors as may be relevant to and
consistent with the public health and safety.
(e) The Attorney General shall register an applicant to
distribute controlled substances in schedule III, IV, or V,
unless he determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) maintenance of effective controls against
diversion of particular controlled substances into
other than legitimate medical, scientific, and
industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled
substances; and
(5) such other factors as may be relevant to and
consistent with the public health and safety.
(f) The Attorney General shall register practitioners
(including pharmacies, as distinguished from pharmacists) to
dispense, or conduct research with, controlled substances in
schedule II, III, IV, or V and shall modify the registrations
of pharmacies so registered to authorize them to dispense
controlled substances by means of the Internet, if the
applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State
in which he practices. The Attorney General may deny an
application for such registration or such modification of
registration if the Attorney General determines that the
issuance of such registration or modification would be
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) The recommendation of the appropriate State
licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or
conducting research with respect to controlled
substances.
(3) The applicant's conviction record under Federal
or State laws relating to the manufacture,
distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or
local laws relating to controlled substances.
(5) Such other conduct which may threaten the public
health and safety.
Separate registration under this part for practitioners
engaging in research with controlled substances in schedule II,
III, IV, or V, who are already registered under this part in
another capacity, shall not be required. Registration
applications by practitioners wishing to conduct research with
controlled substances in schedule I shall be referred to the
Secretary, who shall determine the qualifications and
competency of each practitioner requesting registration, as
well as the merits of the research protocol. The Secretary, in
determining the merits of each research protocol, shall consult
with the Attorney General as to effective procedures to
adequately safeguard against diversion of such controlled
substances from legitimate medical or scientific use.
Registration for the purpose of bona fide research with
controlled substances in schedule I by a practitioner deemed
qualified by the Secretary may be denied by the Attorney
General only on a ground specified in section 304(a). Article 7
of the Convention on Psychotrophic Substances shall not be
construed to prohibit, or impose additional restrictions upon,
research involving drugs or other substances scheduled under
the convention which is conducted in conformity with this
subsection and other applicable provisions of this title.
[(g)(1) Except as provided in paragraph (2), practitioners
who dispense narcotic drugs to individuals for maintenance
treatment or detoxification treatment] (g) Practitioners who
dispense narcotic drugs (other than narcotic drugs in schedule
III, IV, or V) to individuals for maintenance treatment or
detoxification treatment shall obtain annually a separate
registration for that purpose. The Attorney General shall
register an applicant to dispense narcotic drugs to individuals
for maintenance treatment or detoxification treatment (or
both)--
[(A)] (1) if the applicant is a practitioner who is
determined by the Secretary to be qualified (under
standards established by the Secretary) to engage in
the treatment with respect to which registration is
sought;
[(B)] (2) if the Attorney General determines that the
applicant will comply with standards established by the
Attorney General respecting [(i)] (A) security of
stocks of narcotic drugs for such treatment, and [(ii)]
(B) the maintenance of records (in accordance with
section 307) on such drugs; and
[(C)] (3) if the Secretary determines that the
applicant will comply with standards established by the
Secretary (after consultation with the Attorney
General) respecting the quantities of narcotic drugs
which may be provided for unsupervised use by
individuals in such treatment.
[(2)(A) Subject to subparagraphs (D) and (J), the
requirements of paragraph (1) are waived in the case of the
dispensing (including the prescribing), by a practitioner, of
narcotic drugs in schedule III, IV, or V or combinations of
such drugs if the practitioner meets the conditions specified
in subparagraph (B) and the narcotic drugs or combinations of
such drugs meet the conditions specified in subparagraph (C).
[(B) For purposes of subparagraph (A), the conditions
specified in this subparagraph with respect to a
practitioner are that, before the initial dispensing of
narcotic drugs in schedule III, IV, or V or
combinations of such drugs to patients for maintenance
or detoxification treatment, the practitioner submit to
the Secretary a notification of the intent of the
practitioner to begin dispensing the drugs or
combinations for such purpose, and that the
notification contain the following certifications by
the practitioner:
[(i) The practitioner is a qualifying practitioner
(as defined in subparagraph (G)).
[(ii) With respect to patients to whom the
practitioner will provide such drugs or combinations of
drugs, the practitioner has the capacity to provide
directly, by referral, or in such other manner as
determined by the Secretary--
[(I) all drugs approved by the Food and Drug
Administration for the treatment of opioid use
disorder, including for maintenance,
detoxification, overdose reversal, and relapse
prevention; and
[(II) appropriate counseling and other
appropriate ancillary services.
[(iii)(I) The total number of such patients of the
practitioner at any one time will not exceed the
applicable number. Except as provided in subclause
(II), the applicable number is 30.
[(II) The applicable number is--
[(aa) 100 if, not sooner than 1 year after
the date on which the practitioner submitted
the initial notification, the practitioner
submits a second notification to the Secretary
of the need and intent of the practitioner to
treat up to 100 patients;
[(bb) 100 if the practitioner holds
additional credentialing, as defined in section
8.2 of title 42, Code of Federal Regulations
(or successor regulations);
[(cc) 100 if the practitioner provides
medication-assisted treatment (MAT) using
covered medications (as such terms are defined
in section 8.2 of title 42, Code of Federal
Regulations (or successor regulations)) in a
qualified practice setting (as described in
section 8.615 of title 42, Code of Federal
Regulations (or successor regulations)); or
[(dd) 275 if the practitioner meets the
requirements specified in sections 8.610
through 8.655 of title 42, Code of Federal
Regulations (or successor regulations).
[(III) The Secretary may by regulation change such
applicable number.
[(IV) The Secretary may exclude from the applicable
number patients to whom such drugs or combinations of
drugs are directly administered by the qualifying
practitioner in the office setting.
[(C) For purposes of subparagraph (A), the conditions
specified in this subparagraph with respect to narcotic
drugs in schedule III, IV, or V or combinations of such
drugs are as follows:
[(i) The drugs or combinations of drugs have, under
the Federal Food, Drug, and Cosmetic Act or section 351
of the Public Health Service Act, been approved for use
in maintenance or detoxification treatment.
[(ii) The drugs or combinations of drugs have not
been the subject of an adverse determination. For
purposes of this clause, an adverse determination is a
determination published in the Federal Register and
made by the Secretary, after consultation with the
Attorney General, that the use of the drugs or
combinations of drugs for maintenance or detoxification
treatment requires additional standards respecting the
qualifications of practitioners to provide such
treatment, or requires standards respecting the
quantities of the drugs that may be provided for
unsupervised use.
[(D)(i) A waiver under subparagraph (A) with respect to a
practitioner is not in effect unless (in addition to conditions
under subparagraphs (B) and (C)) the following conditions are
met:
[(I) The notification under subparagraph (B) is in
writing and states the name of the practitioner.
[(II) The notification identifies the registration
issued for the practitioner pursuant to subsection (f).
[(III) If the practitioner is a member of a group
practice, the notification states the names of the
other practitioners in the practice and identifies the
registrations issued for the other practitioners
pursuant to subsection (f).
[(ii) Upon receiving a determination from the Secretary under
clause (iii) finding that a practitioner meets all requirements
for a waiver under subparagraph (B), the Attorney General shall
assign the practitioner involved an identification number under
this paragraph for inclusion with the registration issued for
the practitioner pursuant to subsection (f). The identification
number so assigned shall be appropriate to preserve the
confidentiality of patients for whom the practitioner has
dispensed narcotic drugs under a waiver under subparagraph (A).
[(iii) Not later than 45 days after the date on which the
Secretary receives a notification under subparagraph (B), the
Secretary shall make a determination of whether the
practitioner involved meets all requirements for a waiver under
subparagraph (B) and shall forward such determination to the
Attorney General. If the Secretary fails to make such
determination by the end of the such 45-day period, the
Attorney General shall assign the practitioner an
identification number described in clause (ii) at the end of
such period.
[(E)(i) If a practitioner is not registered under paragraph
(1) and, in violation of the conditions specified in
subparagraphs (B) through (D), dispenses narcotic drugs in
schedule III, IV, or V or combinations of such drugs for
maintenance treatment or detoxification treatment, the Attorney
General may, for purposes of section 304(a)(4), consider the
practitioner to have committed an act that renders the
registration of the practitioner pursuant to subsection (f) to
be inconsistent with the public interest.
[(ii)(I) Upon the expiration of 45 days from the date on
which the Secretary receives a notification under subparagraph
(B), a practitioner who in good faith submits a notification
under subparagraph (B) and reasonably believes that the
conditions specified in subparagraphs (B) through (D) have been
met shall, in dispensing narcotic drugs in schedule III, IV, or
V or combinations of such drugs for maintenance treatment or
detoxification treatment, be considered to have a waiver under
subparagraph (A) until notified otherwise by the Secretary,
except that such a practitioner may commence to prescribe or
dispense such narcotic drugs for such purposes prior to the
expiration of such 45-day period if it facilitates the
treatment of an individual patient and both the Secretary and
the Attorney General are notified by the practitioner of the
intent to commence prescribing or dispensing such narcotic
drugs.
[(II) For purposes of subclause (I), the publication in the
Federal Register of an adverse determination by the Secretary
pursuant to subparagraph (C)(ii) shall (with respect to the
narcotic drug or combination involved) be considered to be a
notification provided by the Secretary to practitioners,
effective upon the expiration of the 30-day period beginning on
the date on which the adverse determination is so published.
[(F)(i) With respect to the dispensing of narcotic drugs in
schedule III, IV, or V or combinations of such drugs to
patients for maintenance or detoxification treatment, a
practitioner may, in his or her discretion, dispense such drugs
or combinations for such treatment under a registration under
paragraph (1) or a waiver under subparagraph (A) (subject to
meeting the applicable conditions).
[(ii) This paragraph may not be construed as having any legal
effect on the conditions for obtaining a registration under
paragraph (1), including with respect to the number of patients
who may be served under such a registration.
[(G) For purposes of this paragraph:
[(i) The term ``group practice'' has the meaning
given such term in section 1877(h)(4) of the Social
Security Act.
[(ii) The term ``qualifying physician'' means a
physician who is licensed under State law and who meets
one or more of the following conditions:
[(I) The physician holds a board
certification in addiction psychiatry or
addiction medicine from the American Board of
Medical Specialties.
[(II) The physician holds an addiction
certification or board certification from the
American Society of Addiction Medicine or the
American Board of Addiction Medicine.
[(III) The physician holds a board
certification in addiction medicine from the
American Osteopathic Association.
[(IV) The physician has, with respect to the
treatment and management of opiate-dependent
patients, completed not less than 8 hours of
training (through classroom situations,
seminars at professional society meetings,
electronic communications, or otherwise) that
is provided by the American Society of
Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Psychiatric
Association, or any other organization that the
Secretary determines is appropriate for
purposes of this subclause. Such training shall
include--
[(aa) opioid maintenance and
detoxification;
[(bb) appropriate clinical use of all
drugs approved by the Food and Drug
Administration for the treatment of
opioid use disorder;
[(cc) initial and periodic patient
assessments (including substance use
monitoring);
[(dd) individualized treatment
planning, overdose reversal, and
relapse prevention;
[(ee) counseling and recovery support
services;
[(ff) staffing roles and
considerations;
[(gg) diversion control; and
[(hh) other best practices, as
identified by the Secretary.
[(V) The physician has participated as an
investigator in one or more clinical trials
leading to the approval of a narcotic drug in
schedule III, IV, or V for maintenance or
detoxification treatment, as demonstrated by a
statement submitted to the Secretary by the
sponsor of such approved drug.
[(VI) The physician has such other training
or experience as the State medical licensing
board (of the State in which the physician will
provide maintenance or detoxification
treatment) considers to demonstrate the ability
of the physician to treat and manage opiate-
dependent patients.
[(VII) The physician has such other training
or experience as the Secretary considers to
demonstrate the ability of the physician to
treat and manage opiate-dependent patients. Any
criteria of the Secretary under this subclause
shall be established by regulation. Any such
criteria are effective only for 3 years after
the date on which the criteria are promulgated,
but may be extended for such additional
discrete 3-year periods as the Secretary
considers appropriate for purposes of this
subclause. Such an extension of criteria may
only be effectuated through a statement
published in the Federal Register by the
Secretary during the 30-day period preceding
the end of the 3-year period involved.
[(VIII) The physician graduated in good standing from
an accredited school of allopathic medicine or
osteopathic medicine in the United States during the 5-
year period immediately preceding the date on which the
physician submits to the Secretary a written
notification under subparagraph (B) and successfully
completed a comprehensive allopathic or osteopathic
medicine curriculum or accredited medical residency
that--
[(aa) included not less than 8 hours of
training on treating and managing opioid-
dependent patients; and
[(bb) included, at a minimum--
[(AA) the training described in items
(aa) through (gg) of subclause (IV);
and
[(BB) training with respect to any
other best practice the Secretary
determines should be included in the
curriculum, which may include training
on pain management, including
assessment and appropriate use of
opioid and non-opioid alternatives.
[(iii) The term ``qualifying practitioner'' means--
[(I) a qualifying physician, as defined in
clause (ii);
[(II) a qualifying other practitioner, as
defined in clause (iv), who is a nurse
practitioner or physician assistant; or
[(III) for the period beginning on October 1,
2018, and ending on October 1, 2023, a
qualifying other practitioner, as defined in
clause (iv), who is a clinical nurse
specialist, certified registered nurse
anesthetist, or certified nurse midwife.
[(iv) The term ``qualifying other practitioner''
means a nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist, certified nurse
midwife, or physician assistant who satisfies each of
the following:
[(I) The nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, certified nurse midwife, or
physician assistant is licensed under State law
to prescribe schedule III, IV, or V medications
for the treatment of pain.
[(II) The nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, certified nurse midwife, or
physician assistant has--
[(aa) completed not fewer than 24
hours of initial training addressing
each of the topics listed in clause
(ii)(IV) (through classroom situations,
seminars at professional society
meetings, electronic communications, or
otherwise) provided by the American
Society of Addiction Medicine, the
American Academy of Addiction
Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Nurses
Credentialing Center, the American
Psychiatric Association, the American
Association of Nurse Practitioners, the
American Academy of Physician
Assistants, or any other organization
that the Secretary determines is
appropriate for purposes of this
subclause; or
[(bb) has such other training or
experience as the Secretary determines
will demonstrate the ability of the
nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, certified nurse midwife,
or physician assistant to treat and
manage opiate-dependent patients.
[(III) The nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, certified nurse midwife, or
physician assistant is supervised by, or works
in collaboration with, a qualifying physician,
if the nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, certified nurse midwife, or
physician assistant is required by State law to
prescribe medications for the treatment of
opioid use disorder in collaboration with or
under the supervision of a physician.
The Secretary may, by regulation, revise the requirements for
being a qualifying other practitioner under this clause.
[(H)(i) In consultation with the Administrator of the Drug
Enforcement Administration, the Administrator of the Substance
Abuse and Mental Health Services Administration, the Director
of the National Institute on Drug Abuse, and the Commissioner
of Food and Drugs, the Secretary shall issue regulations
(through notice and comment rulemaking) or issue practice
guidelines to address the following:
[(I) Approval of additional credentialing bodies and
the responsibilities of additional credentialing
bodies.
[(II) Additional exemptions from the requirements of
this paragraph and any regulations under this
paragraph.
[(III) Such other elements of the requirements under
this paragraph as the Secretary determines necessary
for purposes of implementing such requirements.
Nothing in such regulations or practice guidelines may
authorize any Federal official or employee to exercise
supervision or control over the practice of medicine or the
manner in which medical services are provided.
[(ii) Not later than 18 months after the date of enactment of
the Opioid Use Disorder Treatment Expansion and Modernization
Act, the Secretary shall update the treatment improvement
protocol containing best practice guidelines for the treatment
of opioid-dependent patients in office-based settings. The
Secretary shall update such protocol in consultation with
experts in opioid use disorder research and treatment.
[(I) Notwithstanding section 708, nothing in this paragraph
shall be construed to preempt any State law that--
[(i) permits a qualifying practitioner to dispense
narcotic drugs in schedule III, IV, or V, or
combinations of such drugs, for maintenance or
detoxification treatment in accordance with this
paragraph to a total number of patients that is more
than 30 or less than the total number applicable to the
qualifying practitioner under subparagraph (B)(iii)(II)
if a State enacts a law modifying such total number and
the Attorney General is notified by the State of such
modification; or
[(ii) requires a qualifying practitioner to comply
with additional requirements relating to the dispensing
of narcotic drugs in schedule III, IV, or V, or
combinations of such drugs, including requirements
relating to the practice setting in which the
qualifying practitioner practices and education,
training, and reporting requirements.]
(h) The Attorney General shall register an applicant to
distribute a list I chemical unless the Attorney General
determines that registration of the applicant is inconsistent
with the public interest. Registration under this subsection
shall not be required for the distribution of a drug product
that is exempted under clause (iv) or (v) of section
102(39)(A). In determining the public interest for the purposes
of this subsection, the Attorney General shall consider--
(1) maintenance by the applicant of effective
controls against diversion of listed chemicals into
other than legitimate channels;
(2) compliance by the applicant with applicable
Federal, State, and local law;
(3) any prior conviction record of the applicant
under Federal or State laws relating to controlled
substances or to chemicals controlled under Federal or
State law;
(4) any past experience of the applicant in the
manufacture and distribution of chemicals; and
(5) such other factors as are relevant to and
consistent with the public health and safety.
(i)(1) For purposes of registration to manufacture a
controlled substance under subsection (d) for use only in a
clinical trial, the Attorney General shall register the
applicant, or serve an order to show cause upon the applicant
in accordance with section 304(c), not later than 180 days
after the date on which the application is accepted for filing.
(2) For purposes of registration to manufacture a controlled
substance under subsection (a) for use only in a clinical
trial, the Attorney General shall, in accordance with the
regulations issued by the Attorney General, issue a notice of
application not later than 90 days after the application is
accepted for filing. Not later than 90 days after the date on
which the period for comment pursuant to such notice ends, the
Attorney General shall register the applicant, or serve an
order to show cause upon the applicant in accordance with
section 304(c), unless the Attorney General has granted a
hearing on the application under section 1008(i) of the
Controlled Substances Import and Export Act.
(j) Emergency Medical Services That Administer Controlled
Substances.--
(1) Registration.--For the purpose of enabling
emergency medical services professionals to administer
controlled substances in schedule II, III, IV, or V to
ultimate users receiving emergency medical services in
accordance with the requirements of this subsection,
the Attorney General--
(A) shall register an emergency medical
services agency if the agency submits an
application demonstrating it is authorized to
conduct such activity under the laws of each
State in which the agency practices; and
(B) may deny an application for such
registration if the Attorney General determines
that the issuance of such registration would be
inconsistent with the requirements of this
subsection or the public interest based on the
factors listed in subsection (f).
(2) Option for single registration.--In registering
an emergency medical services agency pursuant to
paragraph (1), the Attorney General shall allow such
agency the option of a single registration in each
State where the agency administers controlled
substances in lieu of requiring a separate registration
for each location of the emergency medical services
agency.
(3) Hospital-based agency.--If a hospital-based
emergency medical services agency is registered under
subsection (f), the agency may use the registration of
the hospital to administer controlled substances in
accordance with this subsection without being
registered under this subsection.
(4) Administration outside physical presence of
medical director or authorizing medical professional.--
Emergency medical services professionals of a
registered emergency medical services agency may
administer controlled substances in schedule II, III,
IV, or V outside the physical presence of a medical
director or authorizing medical professional in the
course of providing emergency medical services if the
administration is--
(A) authorized by the law of the State in
which it occurs; and
(B) pursuant to--
(i) a standing order that is issued
and adopted by one or more medical
directors of the agency, including any
such order that may be developed by a
specific State authority; or
(ii) a verbal order that is--
(I) issued in accordance with
a policy of the agency; and
(II) provided by a medical
director or authorizing medical
professional in response to a
request by the emergency
medical services professional
with respect to a specific
patient--
(aa) in the case of a
mass casualty incident;
or
(bb) to ensure the
proper care and
treatment of a specific
patient.
(5) Delivery.--A registered emergency medical
services agency may deliver controlled substances from
a registered location of the agency to an unregistered
location of the agency only if the agency--
(A) designates the unregistered location for
such delivery; and
(B) notifies the Attorney General at least 30
days prior to first delivering controlled
substances to the unregistered location.
(6) Storage.--A registered emergency medical services
agency may store controlled substances--
(A) at a registered location of the agency;
(B) at any designated location of the agency
or in an emergency services vehicle situated at
a registered or designated location of the
agency; or
(C) in an emergency medical services vehicle
used by the agency that is--
(i) traveling from, or returning to,
a registered or designated location of
the agency in the course of responding
to an emergency; or
(ii) otherwise actively in use by the
agency under circumstances that provide
for security of the controlled
substances consistent with the
requirements established by regulations
of the Attorney General.
(7) No treatment as distribution.--The delivery of
controlled substances by a registered emergency medical
services agency pursuant to this subsection shall not
be treated as distribution for purposes of section 308.
(8) Restocking of emergency medical services vehicles
at a hospital.--Notwithstanding paragraph (13)(J), a
registered emergency medical services agency may
receive controlled substances from a hospital for
purposes of restocking an emergency medical services
vehicle following an emergency response, and without
being subject to the requirements of section 308,
provided all of the following conditions are satisfied:
(A) The registered or designated location of
the agency where the vehicle is primarily
situated maintains a record of such receipt in
accordance with paragraph (9).
(B) The hospital maintains a record of such
delivery to the agency in accordance with
section 307.
(C) If the vehicle is primarily situated at a
designated location, such location notifies the
registered location of the agency within 72
hours of the vehicle receiving the controlled
substances.
(9) Maintenance of records.--
(A) In general.--A registered emergency
medical services agency shall maintain records
in accordance with subsections (a) and (b) of
section 307 of all controlled substances that
are received, administered, or otherwise
disposed of pursuant to the agency's
registration, without regard to subsection
307(c)(1)(B).
(B) Requirements.--Such records--
(i) shall include records of
deliveries of controlled substances
between all locations of the agency;
and
(ii) shall be maintained, whether
electronically or otherwise, at each
registered and designated location of
the agency where the controlled
substances involved are received,
administered, or otherwise disposed of.
(10) Other requirements.--A registered emergency
medical services agency, under the supervision of a
medical director, shall be responsible for ensuring
that--
(A) all emergency medical services
professionals who administer controlled
substances using the agency's registration act
in accordance with the requirements of this
subsection;
(B) the recordkeeping requirements of
paragraph (9) are met with respect to a
registered location and each designated
location of the agency;
(C) the applicable physical security
requirements established by regulation of the
Attorney General are complied with wherever
controlled substances are stored by the agency
in accordance with paragraph (6); and
(D) the agency maintains, at a registered
location of the agency, a record of the
standing orders issued or adopted in accordance
with paragraph (9).
(11) Regulations.--The Attorney General may issue
regulations--
(A) specifying, with regard to delivery of
controlled substances under paragraph (5)--
(i) the types of locations that may
be designated under such paragraph; and
(ii) the manner in which a
notification under paragraph (5)(B)
must be made;
(B) specifying, with regard to the storage of
controlled substances under paragraph (6), the
manner in which such substances must be stored
at registered and designated locations,
including in emergency medical service
vehicles; and
(C) addressing the ability of hospitals,
emergency medical services agencies, registered
locations, and designated locations to deliver
controlled substances to each other in the
event of--
(i) shortages of such substances;
(ii) a public health emergency; or
(iii) a mass casualty event.
(12) Rule of construction.--Nothing in this
subsection shall be construed--
(A) to limit the authority vested in the
Attorney General by other provisions of this
title to take measures to prevent diversion of
controlled substances; or
(B) to override the authority of any State to
regulate the provision of emergency medical
services consistent with this subsection.
(13) Definitions.--In this section:
(A) The term ``authorizing medical
professional'' means an emergency or other
physician, or another medical professional
(including an advanced practice registered
nurse or physician assistant)--
(i) who is registered under this Act;
(ii) who is acting within the scope
of the registration; and
(iii) whose scope of practice under a
State license or certification includes
the ability to provide verbal orders.
(B) The term ``designated location'' means a
location designated by an emergency medical
services agency under paragraph (5).
(C) The term ``emergency medical services''
means emergency medical response and emergency
mobile medical services provided outside of a
fixed medical facility.
(D) The term ``emergency medical services
agency'' means an organization providing
emergency medical services, including such an
organization that--
(i) is governmental (including fire-
based and hospital-based agencies),
nongovernmental (including hospital-
based agencies), private, or volunteer-
based;
(ii) provides emergency medical
services by ground, air, or otherwise;
and
(iii) is authorized by the State in
which the organization is providing
such services to provide emergency
medical care, including the
administering of controlled substances,
to members of the general public on an
emergency basis.
(E) The term ``emergency medical services
professional'' means a health care professional
(including a nurse, paramedic, or emergency
medical technician) licensed or certified by
the State in which the professional practices
and credentialed by a medical director of the
respective emergency medical services agency to
provide emergency medical services within the
scope of the professional's State license or
certification.
(F) The term ``emergency medical services
vehicle'' means an ambulance, fire apparatus,
supervisor truck, or other vehicle used by an
emergency medical services agency for the
purpose of providing or facilitating emergency
medical care and transport or transporting
controlled substances to and from the
registered and designated locations.
(G) The term ``hospital-based'' means, with
respect to an agency, owned or operated by a
hospital.
(H) The term ``medical director'' means a
physician who is registered under subsection
(f) and provides medical oversight for an
emergency medical services agency.
(I) The term ``medical oversight'' means
supervision of the provision of medical care by
an emergency medical services agency.
(J) The term ``registered emergency medical
services agency'' means--
(i) an emergency medical services
agency that is registered pursuant to
this subsection; or
(ii) a hospital-based emergency
medical services agency that is covered
by the registration of the hospital
under subsection (f).
(K) The term ``registered location'' means a
location that appears on the certificate of
registration issued to an emergency medical
services agency under this subsection or
subsection (f), which shall be where the agency
receives controlled substances from
distributors.
(L) The term ``specific State authority''
means a governmental agency or other such
authority, including a regional oversight and
coordinating body, that, pursuant to State law
or regulation, develops clinical protocols
regarding the delivery of emergency medical
services in the geographic jurisdiction of such
agency or authority within the State that may
be adopted by medical directors.
(M) The term ``standing order'' means a
written medical protocol in which a medical
director determines in advance the medical
criteria that must be met before administering
controlled substances to individuals in need of
emergency medical services.
(N) The term ``verbal order'' means an oral
directive that is given through any method of
communication including by radio or telephone,
directly to an emergency medical services
professional, to contemporaneously administer a
controlled substance to individuals in need of
emergency medical services outside the physical
presence of the medical director or authorizing
medical professional.
(k) In this section, the phrase ``factors as may be relevant
to and consistent with the public health and safety'' means
factors that are relevant to and consistent with the findings
contained in section 101.
(l) Required Training for Prescribers.--
(1) Training required.--As a condition on
registration under this section to dispense controlled
substances in schedule II, III, IV, or V, the Attorney
General shall require any qualified practitioner,
beginning with the first applicable registration for
the practitioner, to meet the following:
(A) If the practitioner is a physician, the
practitioner meets one or more of the following
conditions:
(i) The physician holds a board
certification in addiction psychiatry
or addiction medicine from the American
Board of Medical Specialties.
(ii) The physician holds a board
certification from the American Board
of Addiction Medicine.
(iii) The physician holds a board
certification in addiction medicine
from the American Osteopathic
Association.
(iv) The physician has, with respect
to the treatment and management of
patients with opioid or other substance
use disorders, completed not less than
8 hours of training (through classroom
situations, seminars at professional
society meetings, electronic
communications, or otherwise) that is
provided by--
(I) the American Society of
Addiction Medicine, the
American Academy of Addiction
Psychiatry, the American
Medical Association, the
American Osteopathic
Association, the American
Psychiatric Association, or any
other organization accredited
by the Accreditation Council
for Continuing Medical
Education (commonly known as
the ``ACCME'');
(II) any organization
accredited by a State medical
society accreditor that is
recognized by the ACCME;
(III) any organization
accredited by the American
Osteopathic Association to
provide continuing medical
education; or
(IV) any organization
approved by the Assistant
Secretary for Mental Health and
Substance Abuse or the ACCME.
(v) The physician graduated in good
standing from an accredited school of
allopathic medicine or osteopathic
medicine in the United States during
the 5-year period immediately preceding
the date on which the physician first
registers or renews under this section
and has successfully completed a
comprehensive allopathic or osteopathic
medicine curriculum or accredited
medical residency that included not
less than 8 hours of training on
treating and managing patients with
opioid and other substance use
disorders, including the appropriate
clinical use of all drugs approved by
the Food and Drug Administration for
the treatment of a substance use
disorder.
(B) If the practitioner is not a physician,
the practitioner meets one or more of the
following conditions:
(i) The practitioner has completed
not fewer than 8 hours of training with
respect to the treatment and management
of patients with opioid or other
substance use disorders (through
classroom situations, seminars at
professional society meetings,
electronic communications, or
otherwise) provided by the American
Society of Addiction Medicine, the
American Academy of Addiction
Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Nurses
Credentialing Center, the American
Psychiatric Association, the American
Association of Nurse Practitioners, the
American Academy of Physician
Associates, or any other organization
approved or accredited by the Assistant
Secretary for Mental Health and
Substance Abuse or the or the
Accreditation Council for Continuing
Medical Education.
(ii) The practitioner has graduated
in good standing from an accredited
physician assistant school or
accredited school of advanced practice
nursing in the United States during the
5-year period immediately preceding the
date on which the practitioner first
registers or renews under this section
and has successfully completed a
comprehensive physician assistant or
advanced practice nursing curriculum
that included not fewer than 8 hours of
training on treating and managing
patients with opioid and other
substance use disorders, including the
appropriate clinical use of all drugs
approved by the Food and Drug
Administration for the treatment of a
substance use disorder.
(2) One-time training.--The Attorney General shall
not require any qualified practitioner to complete the
training described in clause (iv) or (v) of paragraph
(1)(A) or clause (i) or (ii) of paragraph (1)(B) more
than once.
(3) Rule of construction.--Nothing in this subsection
shall be construed to preclude the use, by a qualified
practitioner, of training received pursuant to this
subsection to satisfy registration requirements of a
State or for some other lawful purpose.
(4) Definitions.--In this section:
(A) First applicable registration.--The term
``first applicable registration'' means the
first registration or renewal of registration
by a qualified practitioner under this section
that occurs on or after the date that is 180
days after the date of enactment of the
Restoring Hope for Mental Health and Well-Being
Act of 2022.
(B) Qualified practitioner.--In this
subsection, the term ``qualified practitioner''
means a practitioner who--
(i) is licensed under State law to
prescribe controlled substances; and
(ii) is not solely a veterinarian.
denial, revocation, or suspension of registration
Sec. 304. (a) A registration pursuant to section 303 to
manufacture, distribute, or dispense a controlled substance or
a list I chemical may be suspended or revoked by the Attorney
General upon a finding that the registrant--
(1) has materially falsified any application filed
pursuant to or required by this title or title III;
(2) has been convicted of a felony under this title
or title III or any other law of the United States, or
of any State, relating to any substance defined in this
title as a controlled substance or a list I chemical;
(3) has had his State license or registration
suspended, revoked, or denied by competent State
authority and is no longer authorized by State law to
engage in the manufacturing, distribution, or
dispensing of controlled substances or list I chemicals
or has had the suspension, revocation, or denial of his
registration recommended by competent State authority;
(4) has committed such acts as would render his
registration under section 303 inconsistent with the
public interest as determined under such section; or
(5) has been excluded (or directed to be excluded)
from participation in a program pursuant to section
1128(a) of the Social Security Act.
A registration pursuant to section [303(g)(1)] 303(g) to
dispense a narcotic drug for maintenance treatment or
detoxification treatment may be suspended or revoked by the
Attorney General upon a finding that the registrant has failed
to comply with any standard referred to in section [303(g)(1)]
303(g).
(b) The Attorney General may limit revocation or suspension
of a registration to the particular controlled substance or
list I chemical with respect to which grounds for revocation or
suspension exist.
(c)(1) Before taking action pursuant to this section, or
pursuant to a denial of registration under section 303, the
Attorney General shall serve upon the applicant or registrant
an order to show cause why registration should not be denied,
revoked, or suspended.
(2) An order to show cause under paragraph (1) shall--
(A) contain a statement of the basis for the denial,
revocation, or suspension, including specific citations
to any laws or regulations alleged to be violated by
the applicant or registrant;
(B) direct the applicant or registrant to appear
before the Attorney General at a time and place stated
in the order, but not less than 30 days after the date
of receipt of the order; and
(C) notify the applicant or registrant of the
opportunity to submit a corrective action plan on or
before the date of appearance.
(3) Upon review of any corrective action plan submitted by an
applicant or registrant pursuant to paragraph (2), the Attorney
General shall determine whether denial, revocation, or
suspension proceedings should be discontinued, or deferred for
the purposes of modification, amendment, or clarification to
such plan.
(4) Proceedings to deny, revoke, or suspend shall be
conducted pursuant to this section in accordance with
subchapter II of chapter 5 of title 5, United States Code. Such
proceedings shall be independent of, and not in lieu of,
criminal prosecutions or other proceedings under this title or
any other law of the United States.
(5) The requirements of this subsection shall not apply to
the issuance of an immediate suspension order under subsection
(d).
(d)(1) The Attorney General may, in his discretion, suspend
any registration simultaneously with the institution of
proceedings under this section, in cases where he finds that
there is an imminent danger to the public health or safety. A
failure to comply with a standard referred to in section
[303(g)(1)] 303(g) may be treated under this subsection as
grounds for immediate suspension of a registration granted
under such section. A suspension under this subsection shall
continue in effect until the conclusion of such proceedings,
including judicial review thereof, unless sooner withdrawn by
the Attorney General or dissolved by a court of competent
jurisdiction.
(2) In this subsection, the phrase ``imminent danger to the
public health or safety'' means that, due to the failure of the
registrant to maintain effective controls against diversion or
otherwise comply with the obligations of a registrant under
this title or title III, there is a substantial likelihood of
an immediate threat that death, serious bodily harm, or abuse
of a controlled substance will occur in the absence of an
immediate suspension of the registration.
(e) The suspension or revocation of a registration under this
section shall operate to suspend or revoke any quota applicable
under section 306.
(f) In the event the Attorney General suspends or revokes a
registration granted under section 303, all controlled
substances or list I chemicals owned or possessed by the
registrant pursuant to such registration at the time of
suspension or the effective date of the revocation order, as
the case may be, may, in the discretion of the Attorney
General, be placed under seal. No disposition may be made of
any controlled substances or list I chemicals under seal until
the time for taking an appeal has elapsed or until all appeals
have been concluded except that a court, upon application
therefor, may at any time order the sale of perishable
controlled substances or list I chemicals. Any such order shall
require the deposit of the proceeds of the sale with the court.
Upon a revocation order becoming final, all such controlled
substances or list I chemicals (or proceeds of sale deposited
in court) shall be forfeited to the United States; and the
Attorney General shall dispose of such controlled substances or
list I chemicals in accordance with section 511(e). All right,
title, and interest in such controlled substances or list I
chemicals shall vest in the United States upon a revocation
order becoming final.
(g) The Attorney General may, in his discretion, seize or
place under seal any controlled substances or list I chemicals
owned or possesed by a registrant whose registration has
expired or who has ceased to practice or do business in the
manner contemplated by his registration. Such controlled
substances or list I chemicals shall be held for the benefit of
the registrant, or his successor in interest. The Attorney
General shall notify a registrant, or his successor in
interest, who has any controlled substances or list I chemicals
seized or placed under seal of the procedures to be followed to
secure the return of the controlled substance or list I
chemical and the conditions under which it will be returned.
The Attorney General may not dispose of any controlled
substance or list I chemical seized or placed under seal under
this subsection until the expiration of one hundred and eighty
days from the date such substance or chemical was seized or
placed under seal.
(h) The Attorney General may issue an order to prohibit,
conditionally or unconditionally, and permanently or for such
period as the Attorney General may determine, any person from
being registered under this title to manufacture, distribute,
or dispense a controlled substance or a list I chemical, if the
Attorney General finds that--
(1) such person meets or has met any of the
conditions for suspension or revocation of registration
under subsection (a); and
(2) such person has a history of prior suspensions or
revocations of registration.
* * * * * * *
delivery of a controlled substance by a pharmacy to an administering
practitioner
Sec. 309A. (a) In General.--Notwithstanding section 102(10),
a pharmacy may deliver a controlled substance to a practitioner
in accordance with a prescription that meets the requirements
of this title and the regulations issued by the Attorney
General under this title, for the purpose of administering the
controlled substance by the practitioner if--
(1) the controlled substance is delivered by the
pharmacy to the prescribing practitioner or the
practitioner administering the controlled substance, as
applicable, at the location listed on the
practitioner's certificate of registration issued under
this title;
(2) [the controlled substance is to be administered
for the purpose of maintenance or detoxification
treatment under section 303(g)(2)] the controlled
substance is a narcotic drug in schedule III, IV, or V
to be administered for the purpose of maintenance or
detoxification treatment [and--]
[(A) the practitioner who issued the
prescription is a qualifying practitioner
authorized under, and acting within the scope
of that section; and]
[(B) the controlled substance is to be
administered by injection or implantation;] and
is to be administered by injection or
implantation;
(3) the pharmacy and the practitioner are authorized
to conduct the activities specified in this section
under the law of the State in which such activities
take place;
(4) the prescription is not issued to supply any
practitioner with a stock of controlled substances for
the purpose of general dispensing to patients;
(5) except as provided in subsection (b), the
controlled substance is to be administered only to the
patient named on the prescription not later than 14
days after the date of receipt of the controlled
substance by the practitioner; and
(6) notwithstanding any exceptions under section 307,
the prescribing practitioner, and the practitioner
administering the controlled substance, as applicable,
maintain complete and accurate records of all
controlled substances delivered, received,
administered, or otherwise disposed of under this
section, including the persons to whom controlled
substances were delivered and such other information as
may be required by regulations of the Attorney General.
(b) Modification of Number of Days Before Which Controlled
Substance Shall Be Administered.--
(1) Initial 2-year period.--During the 2-year period
beginning on the date of enactment of this section, the
Attorney General, in coordination with the Secretary,
may reduce the number of days described in subsection
(a)(5) if the Attorney General determines that such
reduction will--
(A) reduce the risk of diversion; or
(B) protect the public health.
(2) Modifications after submission of report.--After
the date on which the report described in section
3204(b) of the SUPPORT for Patients and Communities Act
is submitted, the Attorney General, in coordination
with the Secretary, may modify the number of days
described in subsection (a)(5).
(3) Minimum number of days.--Any modification under
this subsection shall be for a period of not less than
7 days.
* * * * * * *
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SOCIAL SECURITY ACT
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part B--Supplementary Medical Insurance Benefits for the Aged and
Disabled
* * * * * * *
PAYMENT OF BENEFITS
Sec. 1833. (a) Except as provided in section 1876, and
subject to the succeeding provisions of this section, there
shall be paid from the Federal Supplementary Medical Insurance
Trust Fund, in the case of each individual who is covered under
the insurance program established by this part and incurs
expenses for services with respect to which benefits are
payable under this part, amounts equal to--(1) in the case of
services described in section 1832(a)(1)--80 percent of the
reasonable charges for the services; except that (A) an
organization which provides medical and other health services
(or arranges for their availability) on a prepayment basis (and
either is sponsored by a union or employer, or does not
provide, or arrange for the provision of, any inpatient
hospital services) may elect to be paid 80 percent of the
reasonable cost of services for which payment may be made under
this part on behalf of individuals enrolled in such
organization in lieu of 80 percent of the reasonable charges
for such services if the organization undertakes to charge such
individuals no more than 20 percent of such reasonable cost
plus any amounts payable by them as a result of subsection (b),
(B) with respect to items and services described in section
1861(s)(10)(A), the amounts paid shall be 100 percent of the
reasonable charges for such items and services, (C) with
respect to expenses incurred for those physicians' services for
which payment may be made under this part that are described in
section 1862(a)(4), the amounts paid shall be subject to such
limitations as may be prescribed by regulations, (D) with
respect to clinical diagnostic laboratory tests for which
payment is made under this part (i)(I) on the basis of a fee
schedule under subsection (h)(1) (for tests furnished before
January 1, 2017) or section 1834(d)(1), the amount paid shall
be equal to 80 percent (or 100 percent, in the case of such
tests for which payment is made on an assignment-related basis)
of the lesser of the amount determined under such fee schedule,
the limitation amount for that test determined under subsection
(h)(4)(B), or the amount of the charges billed for the tests,
or (II) undersection 1834A (for tests furnished on or after
January1, 2017), the amount paid shall be equal to 80
percent(or 100 percent, in the case of such tests for
whichpayment is made on an assignment-related basis) ofthe
lesser of the amount determined under such sectionor the amount
of the charges billed for the tests, or (ii) for tests
furnished before January 1, 2017,on the basis of a negotiated
rate established under subsection (h)(6), the amount paid shall
be equal to 100 percent of such negotiated rate,,(E) with
respect to services furnished to individuals who have been
determined to have end stage renal disease, the amounts paid
shall be determined subject to the provisions of section
1881,(F) with respect to clinical social worker services under
section 1861(s)(2)(N), the amounts paid shall be 80 percent of
the lesser of (i) the actual charge for the services or (ii) 75
percent of the amount determined for payment of a psychologist
under clause (L),
(G) with respect to facility services
furnished in connection with a surgical
procedure specified pursuant to subsection
(i)(1)(A) and furnished to an individual in an
ambulatory surgical center described in such
subsection, for services furnished beginning
with the implementation date of a revised
payment system for such services in such
facilities specified in subsection (i)(2)(D),
the amounts paid shall be 80 percent of the
lesser of the actual charge for the services or
the amount determined by the Secretary under
such revised payment system,
(H) with respect to services of a certified
registered nurse anesthetist under section 1861(s)(11),
the amounts paid shall be 80 percent of the least of
the actual charge, the prevailing charge that would be
recognized (or, for services furnished on or after
January 1, 1992, the fee schedule amount provided under
section 1848) if the services had been performed by an
anesthesiologist, or the fee schedule for such services
established by the Secretary in accordance with
subsection (l), (I) with respect to covered items
(described in section 1834(a)(13)), the amounts paid
shall be the amounts described in section 1834(a)(1),
and(J) with respect to expenses incurred for
radiologist services (as defined in section
1834(b)(6)), subject to section 1848, the amounts paid
shall be 80 percent of the lesser of the actual charge
for the services or the amount provided under the fee
schedule established under section 1834(b), (K) with
respect to certified nurse-midwife services under
section 1861(s)(2)(L), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph (but in no event shall such fee schedule
exceed 65 percent of the prevailing charge that would
be allowed for the same service performed by a
physician, or, for services furnished on or after
January 1, 1992, 65 percent (or 100 percent for
services furnished on or after January 1, 2011) of the
fee schedule amount provided under section 1848 for the
same service performed by a physician), (L) with
respect to qualified psychologist services under
section 1861(s)(2)(M), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph, (M) with respect to prosthetic devices
and orthotics and prosthetics (as defined in section
1834(h)(4)), the amounts paid shall be the amounts
described in section 1834(h)(1), (N) with respect to
expenses incurred for physicians' services (as defined
in section 1848(j)(3)) other than personalized
prevention plan services (as defined in section
1861(hhh)(1)), the amounts paid shall be 80 percent of
the payment basis determined under section 1848(a)(1),
(O) with respect to services described in section
1861(s)(2)(K) (relating to services furnished by
physician assistants, nurse practitioners, or clinic
nurse specialists), the amounts paid shall be equal to
80 percent of (i) the lesser of the actual charge or 85
percent of the fee schedule amount provided under
section 1848, or (ii) in the case of services as an
assistant at surgery, the lesser of the actual charge
or 85 percent of the amount that would otherwise be
recognized if performed by a physician who is serving
as an assistant at surgery, (P) with respect to
surgical dressings, the amounts paid shall be the
amounts determined under section 1834(i), (Q) with
respect to items or services for which fee schedules
are established pursuant to section 1842(s), the
amounts paid shall be 80 percent of the lesser of the
actual charge or the fee schedule established in such
section, (R) with respect to ambulance services, (i)
the amounts paid shall be 80 percent of the lesser of
the actual charge for the services or the amount
determined by a fee schedule established by the
Secretary under section 1834(l) and (ii) with respect
to ambulance services described in section 1834(l)(8),
the amounts paid shall be the amounts determined under
section 1834(g) for outpatient critical access hospital
services, (S) with respect to drugs and biologicals
(including intravenous immune globulin (as defined in
section 1861(zz))) not paid on a cost or prospective
payment basis as otherwise provided in this part (other
than items and services described in subparagraph (B)),
the amounts paid shall be 80 percent of the lesser of
the actual charge or the payment amount established in
section 1842(o) (or, if applicable, under section 1847,
1847A, or 1847B), (T) with respect to medical nutrition
therapy services (as defined in section 1861(vv)), the
amount paid shall be 80 percent (or 100 percent if such
services are recommended with a grade of A or B by the
United States Preventive Services Task Force for any
indication or population and are appropriate for the
individual) of the lesser of the actual charge for the
services or 85 percent of the amount determined under
the fee schedule established under section 1848(b) for
the same services if furnished by a physician, (U) with
respect to facility fees described in section
1834(m)(2)(B), the amounts paid shall be 80 percent of
the lesser of the actual charge or the amounts
specified in such section, (V) notwithstanding
subparagraphs (I) (relating to durable medical
equipment), (M) (relating to prosthetic devices and
orthotics and prosthetics), and (Q) (relating to
1842(s) items), with respect to competitively priced
items and services (described in section 1847(a)(2))
that are furnished in a competitive area, the amounts
paid shall be the amounts described in section
1847(b)(5), (W) with respect to additional preventive
services (as defined in section 1861(ddd)(1)), the
amount paid shall be (i) in the case of such services
which are clinical diagnostic laboratory tests, the
amount determined under subparagraph (D) (if such
subparagraph were applied, by substituting ``100
percent'' for ``80 percent''), and (ii) in the case of
all other such services, 100 percent of the lesser of
the actual charge for the service or the amount
determined under a fee schedule established by the
Secretary for purposes of this subparagraph, (X) with
respect to personalized prevention plan services (as
defined in section 1861(hhh)(1)), the amount paid shall
be 100 percent of the lesser of the actual charge for
the services or the amount determined under the payment
basis determined under section 1848, (Y) subject to
subsection (dd), with respect to preventive services
described in subparagraphs (A) and (B) of section
1861(ddd)(3) that are appropriate for the individual
and, in the case of such services described in
subparagraph (A), are recommended with a grade of A or
B by the United States Preventive Services Task Force
for any indication or population, the amount paid shall
be 100 percent of (i) except as provided in clause
(ii), the lesser of the actual charge for the services
or the amount determined under the fee schedule that
applies to such services under this part, and (ii) in
the case of such services that are covered OPD services
(as defined in subsection (t)(1)(B)), the amount
determined under subsection (t), (Z) with respect to
Federally qualified health center services for which
payment is made under section 1834(o), the amounts paid
shall be 80 percent of the lesser of the actual charge
or the amount determined under such section, (AA) with
respect to an applicable disposable device (as defined
in paragraph (2) of section 1834(s)) furnished to an
individual pursuant to paragraph (1) of such section,
the amount paid shall be equal to 80 percent of the
lesser of the actual charge or the amount determined
under paragraph (3) of such section, (BB) with respect
to home infusion therapy, the amount paid shall be an
amount equal to 80 percent of the lesser of the actual
charge for the services or the amount determined under
section 1834(u), (CC) with respect to opioid use
disorder treatment services furnished during an episode
of care, the amount paid shall be equal to the amount
payable under section 1834(w) less any copayment
required as specified by the Secretary, and (DD) with
respect to a specified COVID-19 testing-related service
described in paragraph (1) of subsection (cc) for which
payment may be made under a specified outpatient
payment provision described in paragraph (2) of such
subsection, the amounts paid shall be 100 percent of
the payment amount otherwise recognized under such
respective specified outpatient payment provision for
such service,;
(2) in the case of services described in section
1832(a)(2) (except those services described in
subparagraphs (C), (D), (E), (F), (G), (H), and (I) of
such section and unless otherwise specified in section
1881)--
(A) with respect to home health services
(other than a covered osteoporosis drug) (as
defined in section 1861(kk)), the amount
determined under the prospective payment system
under section 1895;
(B) with respect to other items and services
(except those described in subparagraph (C),
(D), or (E) of this paragraph and except as may
be provided in section 1886 or section
1888(e)(9))--
(i) furnished before January 1, 1999,
the lesser of--
(I) the reasonable cost of
such services, as determined
under section 1861(v), or
(II) the customary charges
with respect to such
services,--less the amount a
provider may charge as
described in clause (ii) of
section 1866(a)(2)(A), but in
no case may the payment for
such other services exceed 80
percent of such reasonable
cost, or
(ii) if such services are furnished
before January 1, 1999, by a public
provider of services, or by another
provider which demonstrates to the
satisfaction of the Secretary that a
significant portion of its patients are
low-income (and requests that payment
be made under this clause), free of
charge or at nominal charges to the
public, 80 percent of the amount
determined in accordance with section
1814(b)(2), or
(iii) if such services are furnished
on or after January 1, 1999, the amount
determined under subsection (t), or
(iv) if (and for so long as) the
conditions described in section
1814(b)(3) are met, the amounts
determined under the reimbursement
system described in such section;
(C) with respect to services described in the
second sentence of section 1861(p), 80 percent
of the reasonable charges for such services;
(D) with respect to clinical diagnostic
laboratory tests for which payment is made
under this part (i)(I)on the basis of a fee
schedule determined under subsection(h)(1) (for
tests furnished before January 1, 2017) or
section 1834(d)(1), the amount paid shall be
equal to 80 percent (or 100 percent, in the
case of such tests for which payment is made on
an assignment-related basis or to a provider
having an agreement under section 1866) of the
lesser of the amount determined under such fee
schedule, the limitation amount for that test
determined under subsection (h)(4)(B), or the
amount of the charges billed for the tests, or
(II) under section 1834A (for tests furnished
on or after January 1, 2017), the amount paid
shall be equal to 80 percent (or 100 percent,
in the case of such tests for which payment is
made on an assignment-related basis or to a
provider having an agreement under section
1866) of the lesser of the amount determined
under such section or the amount of the charges
billed for the tests, or (ii) for tests
furnished before January 1, 2017, on the basis
of a negotiated rate established under
subsection (h)(6), the amount paid shall be
equal to 100 percent of such negotiated rate
for such tests;
(E) with respect to--
(i) outpatient hospital radiology
services (including diagnostic and
therapeutic radiology, nuclear medicine
and CAT scan procedures, magnetic
resonance imaging, and ultrasound and
other imaging services, but excluding
screening mammography and, for services
furnished on or after January 1, 2005,
diagnostic mammography), and
(ii) effective for procedures
performed on or after October 1, 1989,
diagnostic procedures (as defined by
the Secretary) described in section
1861(s)(3) (other than diagnostic x-ray
tests and diagnostic laboratory tests),
the amount determined under subsection (n) or,
for services or procedures performed on or
after January 1, 1999, subsection (t);
(F) with respect to a covered osteoporosis
drug (as defined in section 1861(kk)) furnished
by a home health agency, 80 percent of the
reasonable cost of such service, as determined
under section 1861(v);
(G) with respect to items and services
described in section 1861(s)(10)(A), the lesser
of--
(i) the reasonable cost of such
services, as determined under section
1861(v), or
(ii) the customary charges with
respect to such services; and
(H) with respect to personalized prevention
plan services (as defined in section
1861(hhh)(1)) furnished by an outpatient
department of a hospital, the amount determined
under paragraph (1)(X),
or, if such services are furnished by a public
provider of services, or by another provider
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low-income (and requests that
payment be made under this provision), free of
charge or at nominal charges to the public, the
amount determined in accordance with section
1814(b)(2);
(3) in the case of services described in section
1832(a)(2)(D)--
(A) except as provided in subparagraph (B),
the costs which are reasonable and related to
the cost of furnishing such services or which
are based on such other tests of reasonableness
as the Secretary may prescribe in regulations,
including those authorized under section
1861(v)(1)(A), less the amount a provider may
charge as described in clause (ii) of section
1866(a)(2)(A), but in no case may the payment
for such services (other than for items and
services described in section 1861(s)(10)(A))
exceed 80 percent of such costs; or
(B) with respect to the services described in
clause (ii) of section 1832(a)(2)(D) that are
furnished to an individual enrolled with a MA
plan under part C pursuant to a written
agreement described in section 1853(a)(4), the
amount (if any) by which--
(i) the amount of payment that would
have otherwise been provided (I) under
subparagraph (A) (calculated as if
``100 percent'' were substituted for
``80 percent'' in such subparagraph)
for such services if the individual had
not been so enrolled, or (II) in the
case of such services furnished on or
after the implementation date of the
prospective payment system under
section 1834(o), under such section
(calculated as if ``100 percent'' were
substituted for ``80 percent'' in such
section) for such services if the
individual had not been so enrolled;
exceeds
(ii) the amount of the payments
received under such written agreement
for such services (not including any
financial incentives provided for in
such agreement such as risk pool
payments, bonuses, or withholds),
less the amount the federally qualified health
center may charge as described in section
1857(e)(3)(B);
(4) in the case of facility services described in
section 1832(a)(2)(F), and outpatient hospital facility
services furnished in connection with surgical
procedures specified by the Secretary pursuant to
section 1833(i)(1)(A), the applicable amount as
determined under paragraph (2) or (3) of subsection (i)
or subsection (t);
(5) in the case of covered items (described in
section 1834(a)(13)) the amounts described in section
1834(a)(1);
(6) in the case of outpatient critical access
hospital services, the amounts described in section
1834(g);
(7) in the case of prosthetic devices and orthotics
and prosthetics (as described in section 1834(h)(4)),
the amounts described in section 1834(h);
(8) in the case of--
(A) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a rehabilitation agency,
public health agency, clinic,
comprehensive outpatient rehabilitation
facility, or skilled nursing facility,
(ii) by a home health agency to an
individual who is not homebound, or
(iii) by another entity under an
arrangement with an entity described in
clause (i) or (ii); and
(B) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a hospital to an outpatient or
to a hospital inpatient who is entitled
to benefits under part A but has
exhausted benefits for inpatient
hospital services during a spell of
illness or is not so entitled to
benefits under part A, or
(ii) by another entity under an
arrangement with a hospital described
in clause (i),
the amounts described in section 1834(k);
(9) in the case of services described in section
1832(a)(2)(E) that are not described in paragraph (8),
the amounts described in section 1834(k); and
(10) with respect to rural emergency hospital
services furnished on or after January 1, 2023, the
amounts determined under section 1834(x).
Paragraph (3)(A) shall not apply to Federally qualified health
center services furnished on or after the implementation date
of the prospective payment system under section 1834(o). For
services furnished on or after January 1, 2022, paragraph
(1)(Y) shall apply with respect to a colorectal cancer
screening test regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that
is furnished in connection with, as a result of, and in the
same clinical encounter as the screening test.
(b) Before applying subsection (a) with respect to expenses
incurred by an individual during any calendar year, the total
amount of the expenses incurred by such individual during such
year (which would, except for this subsection, constitute
incurred expenses from which benefits payable under subsection
(a) are determinable) shall be reduced by a deductible of $75
for calendar years before 1991, $100 for 1991 through 2004,
$110 for 2005, and for a subsequent year the amount of such
deductible for the previous year increased by the annual
percentage increase in the monthly actuarial rate under section
1839(a)(1) ending with such subsequent year (rounded to the
nearest $1); except that (1) such total amount shall not
include expenses incurred for preventive services described in
subparagraph (A) of section 1861(ddd)(3) that are recommended
with a grade of A or B by the United States Preventive Services
Task Force for any indication or population and are appropriate
for the individual., (2) such deductible shall not apply with
respect to home health services (other than a covered
osteoporosis drug (as defined in section 1861(kk))), (3) such
deductible shall not apply with respect to clinical diagnostic
laboratory tests for which payment is made under this part (A)
under subsection (a)(1)(D)(i) or (a)(2)(D)(i) on an assignment-
related basis, or to a provider having an agreement under
section 1866, or (B) for tests furnished before January 1,
2017,on the basis of a negotiated rate determined under
subsection (h)(6), (4) such deductible shall not apply to
Federally qualified health center services, (5) such deductible
shall not apply with respect to screening mammography (as
described in section 1861(jj)), (6) such deductible shall not
apply with respect to screening pap smear and screening pelvic
exam (as described in section 1861(nn)), (7) such deductible
shall not apply with respect to ultrasound screening for
abdominal aortic aneurysm (as defined in section 1861(bbb)),
(8) such deductible shall not apply with respect to colorectal
cancer screening tests (as described in section 1861(pp)(1)),
(9) such deductible shall not apply with respect to an initial
preventive physical examination (as defined in section
1861(ww)), (10) such deductible shall not apply with respect to
personalized prevention plan services (as defined in section
1861(hhh)(1)), (11) such deductible shall not apply with
respect to any specified COVID-19 testing-related service
described in paragraph (1) of subsection (cc) for which payment
may be made under a specified outpatient payment provision
described in paragraph (2) of such subsection, and (12) such
deductible shall not apply withrespect a COVID-19 vaccine and
its administration describedin section 1861(s)(10)(A). The
total amount of the expenses incurred by an individual as
determined under the preceding sentence shall, after the
reduction specified in such sentence, be further reduced by an
amount equal to the expenses incurred for the first three pints
of whole blood (or equivalent quantities of packed red blood
cells, as defined under regulations) furnished to the
individual during the calendar year, except that such
deductible for such blood shall in accordance with regulations
be appropriately reduced to the extent that there has been a
replacement of such blood (or equivalent quantities of packed
red blood cells, as so defined); and for such purposes blood
(or equivalent quantities of packed red blood cells, as so
defined) furnished such individual shall be deemed replaced
when the institution or other person furnishing such blood (or
such equivalent quantities of packed red blood cells, as so
defined) is given one pint of blood for each pint of blood (or
equivalent quantities of packed red blood cells, as so defined)
furnished such individual with respect to which a deduction is
made under this sentence. The deductible under the previous
sentence for blood or blood cells furnished an individual in a
year shall be reduced to the extent that a deductible has been
imposed under section 1813(a)(2) to blood or blood cells
furnished the individual in the year. Paragraph (1) of the
first sentence of this subsection shall apply with respect to a
colorectal cancer screening test regardless of the code that is
billed for the establishment of a diagnosis as a result of the
test, or for the removal of tissue or other matter or other
procedure that is furnished in connection with, as a result of,
and in the same clinical encounter as the screening test.
(c)(1) Notwithstanding any other provision of this part, with
respect to expenses incurred in a calendar year in connection
with the treatment of mental, psychoneurotic, and personality
disorders of an individual who is not an inpatient of a
hospital at the time such expenses are incurred, there shall be
considered as incurred expenses for purposes of subsections (a)
and (b)--
(A) for expenses incurred in years prior to 2010,
only 62\1/2\ percent of such expenses;
(B) for expenses incurred in 2010 or 2011, only 68\3/
4\ percent of such expenses;
(C) for expenses incurred in 2012, only 75 percent of
such expenses;
(D) for expenses incurred in 2013, only 81\1/4\
percent of such expenses; and
(E) for expenses incurred in 2014 or any subsequent
calendar year, 100 percent of such expenses.
(2) For purposes of subparagraphs (A) through (D) of
paragraph (1), the term ``treatment'' does not include brief
office visits (as defined by the Secretary) for the sole
purpose of monitoring or changing drug prescriptions used in
the treatment of such disorders or partial hospitalization
services that are not directly provided by a physician
(d) No payment may be made under this part with respect to
any services furnished an individual to the extent that such
individual is entitled (or would be entitled except for section
1813) to have payment made with respect to such services under
part A.
(e) No payment shall be made to any provider of services or
other person under this part unless there has been furnished
such information as may be necessary in order to determine the
amounts due such provider or other person under this part for
the period with respect to which the amounts are being paid or
for any prior period.
(f)(1) In establishing limits under subsection (a) on payment
for rural health clinic services provided by rural health
clinics (other than such clinics in hospitals with less than 50
beds), the Secretary shall establish such limit, for services
provided prior to April 1, 2021--
(A) in 1988, after March 31, at $46 per visit, and
(B) in a subsequent year (before April 1, 2021), at
the limit established under this paragraph for the
previous year increased by the percentage increase in
the MEI (as defined in section 1842(i)(3)) applicable
to primary care services (as defined in section
1842(i)(4)) furnished as of the first day of that year.
(2) In establishing limits under subsection (a) on payment
for rural health clinic services furnished on or after April 1,
2021, by a rural health clinic (other than a rural health
clinic described in paragraph (3)(B)), the Secretary shall
establish such limit, for services provided--
(A) in 2021, after March 31, at $100 per visit;
(B) in 2022, at $113 per visit;
(C) in 2023, at $126 per visit;
(D) in 2024, at $139 per visit;
(E) in 2025, at $152 per visit;
(F) in 2026, at $165 per visit;
(G) in 2027, at $178 per visit;
(H) in 2028, at $190 per visit; and
(I) in a subsequent year, at the limit established
under this paragraph for the previous year increased by
the percentage increase in the MEI applicable to
primary care services furnished as of the first day of
such subsequent year.
(3)(A) In establishing limits under subsection (a) on payment
for rural health clinic services furnished on or after April 1,
2021, by a rural health clinic described in subparagraph (B),
the Secretary shall establish such limit, with respect to each
such rural health clinic, for services provided--
(i) in 2021, after March 31, at an amount equal to
the greater of--
(I) with respect to a rural health
clinic that had a per visit payment
amount established for services
furnished in 2020--
(aa) the per visit payment
amount applicable to such rural
health clinic for rural health
clinic services furnished in
2020, increased by the
percentage increase in the MEI
applicable to primary care
services furnished as of the
first day of 2021; or
(bb) the limit described in
paragraph (2)(A); and
(II) with respect to a rural health
clinic that did not have a per visit
payment amount established for services
furnished in 2020--
(aa) the per visit payment
amount applicable to such rural
health clinic for rural health
clinic services furnished in
2021; or
(bb) the limit described in
paragraph (2)(A); and
(ii) in a subsequent year, at an amount equal to the
greater of--
(I) the amount established under subclause
(I) or (II) of clause (i), as applicable, or
this subclause for the previous year with
respect to such rural health clinic, increased
by the percentage increase in the MEI
applicable to primary care services furnished
as of the first day of such subsequent year; or
(II) the limit established under paragraph
(2) for such subsequent year.
(B) A rural health clinic described in this subparagraph is a
rural health clinic that--
(i) as of December 31, 2020, was in a hospital with
less than 50 beds and after such date such hospital
continues to have less than 50 beds (not taking into
account any increase in the number of beds pursuant to
a waiver under subsection (b)(1)(A) of section 1135
during the emergency period described in subsection
(g)(1)(B) of such section); and
(ii)(I) as of December 31, 2020, was enrolled under
section 1866(j) (including temporary enrollment during
such emergency period for such emergency period); or
(II) submitted an application for enrollment under
section 1866(j) (or a request for such a temporary
enrollment for such emergency period) that was received
not later than December 31, 2020.
(g)(1)(A) Subject to paragraphs (4) and (5), in the case of
physical therapy services of the type described in section
1861(p) and speech-language pathology services of the type
described in such section through the application of section
1861(ll)(2), but (except as provided in paragraph (6)) not
described in subsection (a)(8)(B), and physical therapy
services and speech-language pathology services of such type
which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, no more than the amount specified in paragraph
(2) for the year shall be considered as incurred expenses for
purposes of subsections (a) and (b). The preceding sentence
shall not apply to expenses incurred with respect to services
furnished after December 31, 2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of physical therapy services of
the type described in section 1861(p), speech-language
pathology services of the type described in such section
through the application of section 1861(ll)(2), and physical
therapy services and speech-language pathology services of such
type which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, any amount that is more than the amount
specified in paragraph (2) for the year shall not be considered
as incurred expenses for purposes of subsections (a) and (b)
unless the applicable requirements of paragraph (7) are met.
(2) The amount specified in this paragraph--
(A) for 1999, 2000, and 2001, is $1,500, and
(B) for a subsequent year is the amount specified in
this paragraph for the preceding year increased by the
percentage increase in the MEI (as defined in section
1842(i)(3)) for such subsequent year;
except that if an increase under subparagraph (B) for a year is
not a multiple of $10, it shall be rounded to the nearest
multiple of $10.
(3)(A) Subject to paragraphs (4) and (5), in the case of
occupational therapy services (of the type that are described
in section 1861(p) (but (except as provided in paragraph (6))
not described in subsection (a)(8)(B)) through the operation of
section 1861(g) and of such type which are furnished by a
physician or as incident to physicians' services), with respect
to expenses incurred in any calendar year, no more than the
amount specified in paragraph (2) for the year shall be
considered as incurred expenses for purposes of subsections (a)
and (b). The preceding sentence shall not apply to expenses
incurred with respect to services furnished after December 31,
2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of occupational therapy services
(of the type that are described in section 1861(p) through the
operation of section 1861(g) and of such type which are
furnished by a physician or as incident to physicians'
services), with respect to expenses incurred in any calendar
year, any amount that is more than the amount specified in
paragraph (2) for the year shall not be considered as incurred
expenses for purposes of subsections (a) and (b) unless the
applicable requirements of paragraph (7) are met.
(4) This subsection shall not apply to expenses incurred with
respect to services furnished during 2000, 2001, 2002, 2004,
and 2005.
(5)(A) With respect to expenses incurred during the period
beginning on January 1, 2006, and ending on December 31, 2017,
for services, the Secretary shall implement a process under
which an individual enrolled under this part may, upon request
of the individual or a person on behalf of the individual,
obtain an exception from the uniform dollar limitation
specified in paragraph (2), for services described in
paragraphs (1) and (3) if the provision of such services is
determined to be medically necessary and if the requirement of
subparagraph (B) is met. Under such process, if the Secretary
does not make a decision on such a request for an exception
within 10 business days of the date of the Secretary's receipt
of the request made in accordance with such requirement, the
Secretary shall be deemed to have found the services to be
medically necessary.
(B) In the case of outpatient therapy services for which an
exception is requested under the first sentence of subparagraph
(A), the claim for such services shall contain an appropriate
modifier (such as the KX modifier used as of the date of the
enactment of this subparagraph) indicating that such services
are medically necessary as justified by appropriate
documentation in the medical record involved.
(C)(i) In applying this paragraph with respect to a request
for an exception with respect to expenses that would be
incurred for outpatient therapy services (including services
described in subsection (a)(8)(B)) that would exceed the
threshold described in clause (ii) for a year, the request for
such an exception, for services furnished on or after October
1, 2012, shall be subject to a manual medical review process
that, subject to subparagraph (E), is similar to the manual
medical review process used for certain exceptions under this
paragraph in 2006.
(ii) The threshold under this clause for a year is $3,700.
Such threshold shall be applied separately--
(I) for physical therapy services and speech-language
pathology services; and
(II) for occupational therapy services.
(E)(i) In place of the manual medical review process under
subparagraph (C)(i), the Secretary shall implement a process
for medical review under this subparagraph under which the
Secretary shall identify and conduct medical review for
services described in subparagraph (C)(i) furnished by a
provider of services or supplier (in this subparagraph referred
to as a ``therapy provider'') using such factors as the
Secretary determines to be appropriate.
(ii) Such factors may include the following:
(I) The therapy provider has had a high claims denial
percentage for therapy services under this part or is
less compliant with applicable requirements under this
title.
(II) The therapy provider has a pattern of billing
for therapy services under this part that is aberrant
compared to peers or otherwise has questionable billing
practices for such services, such as billing medically
unlikely units of services in a day.
(III) The therapy provider is newly enrolled under
this title or has not previously furnished therapy
services under this part.
(IV) The services are furnished to treat a type of
medical condition.
(V) The therapy provider is part of group that
includes another therapy provider identified using the
factors determined under this subparagraph.
(iii) For purposes of carrying out this subparagraph, the
Secretary shall provide for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund under section 1841,
of $5,000,000 to the Centers for Medicare & Medicaid Services
Program Management Account for fiscal years 2015 and 2016, to
remain available until expended. Such funds may not be used by
a contractor under section 1893(h) for medical reviews under
this subparagraph.
(iv) The targeted review process under this subparagraph
shall not apply to services for which expenses are incurred
beyond the period for which the exceptions process under
subparagraph (A) is implemented, except as such process is
applied under paragraph (7)(B).
(6)(A) In applying paragraphs (1) and (3) to services
furnished during the period beginning not later than October 1,
2012, and ending on December 31, 2017, the exclusion of
services described in subsection (a)(8)(B) from the uniform
dollar limitation specified in paragraph (2) shall not apply to
such services furnished during 2012 through 2017.
(B)(i) With respect to outpatient therapy services furnished
beginning on or after January 1, 2013, and before January 1,
2014, for which payment is made under section 1834(g), the
Secretary shall count toward the uniform dollar limitations
described in paragraphs (1) and (3) and the threshold described
in paragraph (5)(C) the amount that would be payable under this
part if such services were paid under section 1834(k)(1)(B)
instead of being paid under section 1834(g).
(ii) Nothing in clause (i) shall be construed as changing the
method of payment for outpatient therapy services under section
1834(g).
(7) For purposes of paragraphs (1)(B) and (3)(B), with
respect to services described in such paragraphs, the
requirements described in this paragraph are as follows:
(A) Inclusion of appropriate modifier.--The claim for
such services contains an appropriate modifier (such as
the KX modifier described in paragraph (5)(B))
indicating that such services are medically necessary
as justified by appropriate documentation in the
medical record involved.
(B) Targeted medical review for certain services
above threshold.--
(i) In general.--In the case where expenses
that would be incurred for such services would
exceed the threshold described in clause (ii)
for the year, such services shall be subject to
the process for medical review implemented
under paragraph (5)(E).
(ii) Threshold.--The threshold under this
clause for--
(I) a year before 2028, is $3,000;
(II) 2028, is the amount specified in
subclause (I) increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for
2028; and
(III) a subsequent year, is the
amount specified in this clause for the
preceding year increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for such
subsequent year;
except that if an increase under subclause (II)
or (III) for a year is not a multiple of $10,
it shall be rounded to the nearest multiple of
$10.
(iii) Application.--The threshold under
clause (ii) shall be applied separately--
(I) for physical therapy services and
speech-language pathology services; and
(II) for occupational therapy
services.
(iv) Funding.--For purposes of carrying out
this subparagraph, the Secretary shall provide
for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund
under section 1841 to the Centers for Medicare
& Medicaid Services Program Management Account,
of $5,000,000 for each fiscal year beginning
with fiscal year 2018, to remain available
until expended. Such funds may not be used by a
contractor under section 1893(h) for medical
reviews under this subparagraph.
(8) With respect to services furnished on or after January 1,
2013, where payment may not be made as a result of application
of paragraphs (1) and (3), section 1879 shall apply in the same
manner as such section applies to a denial that is made by
reason of section 1862(a)(1).
(h)(1)(A) Subject to section 1834(d)(1), the Secretary shall
establish fee schedules for clinical diagnostic laboratory
tests (including prostate cancer screening tests under section
1861(oo) consisting of prostate-specific antigen blood tests)
for which payment is made under this part, other than such
tests performed by a provider of services for an inpatient of
such provider.
(B) In the case of clinical diagnostic laboratory tests
performed by a physician or by a laboratory (other than tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital), the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(C) In the case of clinical diagnostic laboratory tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital, the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(D) In this subsection, the term ``qualified hospital
laboratory'' means a hospital laboratory, in a sole community
hospital (as defined in section 1886(d)(5)(D)(iii)), which
provides some clinical diagnostic laboratory tests 24 hours a
day in order to serve a hospital emergency room which is
available to provide services 24 hours a day and 7 days a week.
(2)(A)(i) Except as provided in clause (v), subparagraph (B),
and paragraph (4), the Secretary shall set the fee schedules at
60 percent (or, in the case of a test performed by a qualified
hospital laboratory (as defined in paragraph (1)(D)) for
outpatients of such hospital, 62 percent) of the prevailing
charge level determined pursuant to the third and fourth
sentences of section 1842(b)(3) for similar clinical diagnostic
laboratory tests for the applicable region, State, or area for
the 12-month period beginning July 1, 1984, adjusted annually
(to become effective on January 1 of each year) by, subject to
clause (iv), a percentage increase or decrease equal to the
percentage increase or decrease in the Consumer Price Index for
All Urban Consumers (United States city average) minus, for
each of the years 2009 and 2010, 0.5 percentage points, and,
for tests furnished before the dateof enactment of section
1834A, subject to such other adjustments as the Secretary
determines are justified by technological changes.
(ii) Notwithstanding clause (i)--
(I) any change in the fee schedules which would have
become effective under this subsection for tests
furnished on or after January 1, 1988, shall not be
effective for tests furnished during the 3-month period
beginning on January 1, 1988,
(II) the Secretary shall not adjust the fee schedules
under clause (i) to take into account any increase in
the consumer price index for 1988,
(III) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1991,
1992, and 1993 shall be 2 percent, and
(IV) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1994
and 1995, 1998 through 2002, and 2004 through 2008
shall be 0 percent.
(iii) In establishing fee schedules under clause (i) with
respect to automated tests and tests (other than cytopathology
tests) which before July 1, 1984, the Secretary made subject to
a limit based on lowest charge levels under the sixth sentence
of section 1842(b)(3) performed after March 31, 1988, the
Secretary shall reduce by 8.3 percent the fee schedules
otherwise established for 1988, and such reduced fee schedules
shall serve as the base for 1989 and subsequent years.
(iv) After determining the adjustment to the fee schedules
under clause (i), the Secretary shall reduce such adjustment--
(I) for 2011 and each subsequent year, by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II); and
(II) for each of 2011 through 2015, by 1.75
percentage points.
Subclause (I) shall not apply in a year where the adjustment to
the fee schedules determined under clause (i) is 0.0 or a
percentage decrease for a year. The application of the
productivity adjustment under subclause (I) shall not result in
an adjustment to the fee schedules under clause (i) being less
than 0.0 for a year. The application of subclause (II) may
result in an adjustment to the fee schedules under clause (i)
being less than 0.0 for a year, and may result in payment rates
for a year being less than such payment rates for the preceding
year.
(v) The Secretary shall reduce by 2 percent the fee schedules
otherwise determined under clause (i) for 2013, and such
reduced fee schedules shall serve as the base for 2014 and
subsequent years.
(B) The Secretary may make further adjustments or exceptions
to the fee schedules to assure adequate reimbursement of (i)
emergency laboratory tests needed for the provision of bona
fide emergency services, and (ii) certain low volume high-cost
tests where highly sophisticated equipment or extremely skilled
personnel are necessary to assure quality.
(3) In addition to the amounts provided under the fee
schedules (for tests furnished before January 1, 2017)or under
section 1834A (for tests furnished on or afterJanuary 1, 2017),
subject to subsection (b)(5) of such section, the Secretary
shall provide for and establish (A) a nominal fee to cover the
appropriate costs in collecting the sample on which a clinical
diagnostic laboratory test was performed and for which payment
is made under this part, except that not more than one such fee
may be provided under this paragraph with respect to samples
collected in the same encounter, and (B) a fee to cover the
transportation and personnel expenses for trained personnel to
travel to the location of an individual to collect the sample,
except that such a fee may be provided only with respect to an
individual who is homebound or an inpatient in an inpatient
facility (other than a hospital). In establishing a fee to
cover the transportation and personnel expenses for trained
personnel to travel to the location of an individual to collect
a sample, the Secretary shall provide a method for computing
the fee based on the number of miles traveled and the personnel
costs associated with the collection of each individual sample,
but the Secretary shall only be required to apply such method
in the case of tests furnished during the period beginning on
April 1, 1989, and ending on December 31, 1990, by a laboratory
that establishes to the satisfaction of the Secretary (based on
data for the 12-month period ending June 30, 1988) that (i) the
laboratory is dependent upon payments under this title for at
least 80 percent of its collected revenues for clinical
diagnostic laboratory tests, (ii) at least 85 percent of its
gross revenues for such tests are attributable to tests
performed with respect to individuals who are homebound or who
are residents in a nursing facility, and (iii) the laboratory
provided such tests for residents in nursing facilities
representing at least 20 percent of the number of such
facilities in the State in which the laboratory is located.
(4)(A) In establishing any fee schedule under this
subsection, the Secretary may provide for an adjustment to take
into account, with respect to the portion of the expenses of
clinical diagnostic laboratory tests attributable to wages, the
relative difference between a region's or local area's wage
rates and the wage rate presumed in the data on which the
schedule is based.
(B) For purposes of subsections (a)(1)(D)(i) and
(a)(2)(D)(i), the limitation amount for a clinical diagnostic
laboratory test performed--
(i) on or after July 1, 1986, and before April 1,
1988, is equal to 115 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(ii) after March 31, 1988, and before January 1,
1990, is equal to the median of all the fee schedules
established for that test for that laboratory setting
under paragraph (1),
(iii) after December 31, 1989, and before January 1,
1991, is equal to 93 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(iv) after December 31, 1990, and before January 1,
1994, is equal to 88 percent of such median,
(v) after December 31, 1993, and before January 1,
1995, is equal to 84 percent of such median,
(vi) after December 31, 1994, and before January 1,
1996, is equal to 80 percent of such median,
(vii) after December 31, 1995, and before January 1,
1998, is equal to 76 percent of such median, and
(viii) after December 31, 1997, is equal to 74
percent of such median (or 100 percent of such median
in the case of a clinical diagnostic laboratory test
performed on or after January 1, 2001, that the
Secretary determines is a new test for which no
limitation amount has previously been established under
this subparagraph).
(5)(A) In the case of a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part on an assignment-related
basis or under a provider agreement under section 1866, payment
may be made only to the person or entity which performed or
supervised the performance of such test; except that--
(i) if a physician performed or supervised the
performance of such test, payment may be made to
another physician with whom he shares his practice,
(ii) in the case of a test performed at the request
of a laboratory by another laboratory, payment may be
made to the referring laboratory but only if--
(I) the referring laboratory is located in,
or is part of, a rural hospital,
(II) the referring laboratory is wholly owned
by the entity performing such test, the
referring laboratory wholly owns the entity
performing such test, or both the referring
laboratory and the entity performing such test
are wholly-owned by a third entity, or
(III) not more than 30 percent of the
clinical diagnostic laboratory tests for which
such referring laboratory (but not including a
laboratory described in subclause (II)),
receives requests for testing during the year
in which the test is performed are performed by
another laboratory, and
(iii) in the case of a clinical diagnostic laboratory
test provided under an arrangement (as defined in
section 1861(w)(1)) made by a hospital, critical access
hospital, or skilled nursing facility, payment shall be
made to the hospital or skilled nursing facility.
(B) In the case of such a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part, and which is not described
in subparagraph (A), payment may be made to the beneficiary
only on the basis of the itemized bill of the person or entity
which performed or supervised the performance of the test.
(C) Payment for a clinical diagnostic laboratory test,
including a test performed in a physician's office but
excluding a test performed by a rural health clinic may only be
made on an assignment-related basis or to a provider of
services with an agreement in effect under section 1866.
(D) A person may not bill for a clinical diagnostic
laboratory test, including a test performed in a physician's
office but excluding a test performed by a rural health clinic,
other than on an assignment-related basis. If a person
knowingly and willfully and on a repeated basis bills for a
clinical diagnostic laboratory test in violation of the
previous sentence, the Secretary may apply sanctions against
the person in the same manner as the Secretary may apply
sanctions against a physician in accordance with paragraph (2)
of section 1842(j) in the same manner such paragraphs apply
with respect to a physician. Paragraph (4) of such section
shall apply in this subparagraph in the same manner as such
paragraph applies to such section.
(6) For tests furnished before January 1, 2017, inthe case of
any diagnostic laboratory test payment for which is not made on
the basis of a fee schedule under paragraph (1), the Secretary
may establish a payment rate which is acceptable to the person
or entity performing the test and which would be considered the
full charge for such tests. Such negotiated rate shall be
limited to an amount not in excess of the total payment that
would have been made for the services in the absence of such
rate.
(7) Notwithstanding paragraphs (1) and (4)and section 1834A,
the Secretary shall establish a national minimum payment amount
under this part for a diagnostic or screening pap smear
laboratory test (including all cervical cancer screening
technologies that have been approved by the Food and Drug
Administration as a primary screening method for detection of
cervical cancer) equal to $14.60 for tests furnished in 2000.
For such tests furnished in subsequent years, such national
minimum payment amount shall be adjusted annually as provided
in paragraph (2).
(8)(A) The Secretary shall establish by regulation procedures
for determining the basis for, and amount of, payment under
this subsection for any clinical diagnostic laboratory test
with respect to which a new or substantially revised HCPCS code
is assigned on or after January 1, 2005 (in this paragraph
referred to as ``new tests'').
(B) Determinations under subparagraph (A) shall be made only
after the Secretary--
(i) makes available to the public (through an
Internet website and other appropriate mechanisms) a
list that includes any such test for which
establishment of a payment amount under this subsection
is being considered for a year;
(ii) on the same day such list is made available,
causes to have published in the Federal Register notice
of a meeting to receive comments and recommendations
(and data on which recommendations are based) from the
public on the appropriate basis under this subsection
for establishing payment amounts for the tests on such
list;
(iii) not less than 30 days after publication of such
notice convenes a meeting, that includes
representatives of officials of the Centers for
Medicare & Medicaid Services involved in determining
payment amounts, to receive such comments and
recommendations (and data on which the recommendations
are based);
(iv) taking into account the comments and
recommendations (and accompanying data) received at
such meeting, develops and makes available to the
public (through an Internet website and other
appropriate mechanisms) a list of proposed
determinations with respect to the appropriate basis
for establishing a payment amount under this subsection
for each such code, together with an explanation of the
reasons for each such determination, the data on which
the determinations are based, and a request for public
written comments on the proposed determination; and
(v) taking into account the comments received during
the public comment period, develops and makes available
to the public (through an Internet website and other
appropriate mechanisms) a list of final determinations
of the payment amounts for such tests under this
subsection, together with the rationale for each such
determination, the data on which the determinations are
based, and responses to comments and suggestions
received from the public.
(C) Under the procedures established pursuant to subparagraph
(A), the Secretary shall--
(i) set forth the criteria for making determinations
under subparagraph (A); and
(ii) make available to the public the data (other
than proprietary data) considered in making such
determinations.
(D) The Secretary may convene such further public meetings to
receive public comments on payment amounts for new tests under
this subsection as the Secretary deems appropriate.
(E) For purposes of this paragraph:
(i) The term ``HCPCS'' refers to the Health Care
Procedure Coding System.
(ii) A code shall be considered to be ``substantially
revised'' if there is a substantive change to the
definition of the test or procedure to which the code
applies (such as a new analyte or a new methodology for
measuring an existing analyte-specific test).
(9) Notwithstanding any other provision in this part, in the
case of any diagnostic laboratory test for HbA1c that is
labeled by the Food and Drug Administration for home use and is
furnished on or after April 1, 2008, the payment rate for such
test shall be the payment rate established under this part for
a glycated hemoglobin test (identified as of October 1, 2007,
by HCPCS code 83036 (and any succeeding codes)).
(i)(1) The Secretary shall, in consultation with appropriate
medical organizations--
(A) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in an
ambulatory surgical center (meeting the standards
specified under section 1832(a)(2)(F)(i)), critical
access hospital, or hospital outpatient department, and
(B) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in a
physician's office.
The lists of procedures established under subparagraphs (A) and
(B) shall be reviewed and updated not less often than every 2
years, in consultation with appropriate trade and professional
organizations.
(2)(A) For services furnished prior to the implementation of
the system described in subparagraph (D), subject to
subparagraph (E), the amount of payment to be made for facility
services furnished in connection with a surgical procedure
specified pursuant to paragraph (1)(A) and furnished to an
individual in an ambulatory surgical center described in such
paragraph shall be equal to 80 percent of a standard overhead
amount established by the Secretary (with respect to each such
procedure) on the basis of the Secretary's estimate of a fair
fee which--
(i) takes into account the costs incurred by such
centers, or classes of centers, generally in providing
services furnished in connection with the performance
of such procedure, as determined in accordance with a
survey (based upon a representative sample of
procedures and facilities) of the actual audited costs
incurred by such centers in providing such services,
(ii) takes such costs into account in such a manner
as will assure that the performance of the procedure in
such a center will result in substantially less amounts
paid under this title than would have been paid if the
procedure had been performed on an inpatient basis in a
hospital, and
(iii) in the case of insertion of an intraocular lens
during or subsequent to cataract surgery includes
payment which is reasonable and related to the cost of
acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(B) The amount of payment to be made under this part for
facility services furnished, in connection with a surgical
procedure specified pursuant to paragraph (1)(B), in a
physician's office shall be equal to 80 percent of a standard
overhead amount established by the Secretary (with respect to
each such procedure) on the basis of the Secretary's estimate
of a fair fee which--
(i) takes into account additional costs, not usually
included in the professional fee, incurred by
physicians in securing, maintaining, and staffing the
facilities and ancillary services appropriate for the
performance of such procedure in the physician's
office, and
(ii) takes such items into account in such a manner
which will assure that the performance of such
procedure in the physician's office will result in
substantially less amounts paid under this title than
would have been paid if the services had been furnished
on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(C)(i) Notwithstanding the second sentence of each of
subparagraphs (A) and (B), except as otherwise specified in
clauses (ii), (iii), and (iv), if the Secretary has not updated
amounts established under such subparagraphs or under
subparagraph (D), with respect to facility services furnished
during a fiscal year (beginning with fiscal year 1986 or a
calendar year (beginning with 2006)), such amounts shall be
increased by the percentage increase in the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with the
midpoint of the year involved.
(ii) In each of the fiscal years 1998 through 2002, the
increase under this subparagraph shall be reduced (but not
below zero) by 2.0 percentage points.
(iii) In fiscal year 2004, beginning with April 1, 2004, the
increase under this subparagraph shall be the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with March 31,
2003, minus 3.0 percentage points.
(iv) In fiscal year 2005, the last quarter of calendar year
2005, and each of calendar years 2006 through 2009, the
increase under this subparagraph shall be 0 percent.
(D)(i) Taking into account the recommendations in the report
under section 626(d) of Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, the Secretary shall
implement a revised payment system for payment of surgical
services furnished in ambulatory surgical centers.
(ii) In the year the system described in clause (i) is
implemented, such system shall be designed to result in the
same aggregate amount of expenditures for such services as
would be made if this subparagraph did not apply, as estimated
by the Secretary and taking into account reduced expenditures
that would apply if subparagraph (E) were to continue to apply,
as estimated by the Secretary.
(iii) The Secretary shall implement the system described in
clause (i) for periods in a manner so that it is first
effective beginning on or after January 1, 2006, and not later
than January 1, 2008.
(iv) The Secretary may implement such system in a manner so
as to provide for a reduction in any annual update for failure
to report on quality measures in accordance with paragraph (7).
(v) In implementing the system described in clause
(i) for 2011 and each subsequent year, any annual
update under such system for the year, after
application of clause (iv), shall be reduced by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the preceding
sentence may result in such update being less than 0.0
for a year, and may result in payment rates under the
system described in clause (i) for a year being less
than such payment rates for the preceding year.
(vi) There shall be no administrative or judicial review
under section 1869, 1878, or otherwise, of the classification
system, the relative weights, payment amounts, and the
geographic adjustment factor, if any, under this subparagraph.
(E) With respect to surgical procedures furnished on or after
January 1, 2007, and before the effective date of the
implementation of a revised payment system under subparagraph
(D), if--
(i) the standard overhead amount under subparagraph
(A) for a facility service for such procedure, without
the application of any geographic adjustment, exceeds
(ii) the Medicare OPD fee schedule amount established
under the prospective payment system for hospital
outpatient department services under paragraph (3)(D)
of section 1833(t) for such service for such year,
determined without regard to geographic adjustment
under paragraph (2)(D) of such section,
the Secretary shall substitute under subparagraph (A) the
amount described in clause (ii) for the standard overhead
amount for such service referred to in clause (i).
(3)(A) The aggregate amount of the payments to be made under
this part for outpatient hospital facility services or critical
access hospital services furnished before January 1, 1999, in
connection with surgical procedures specified under paragraph
(1)(A) shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B); or
(ii) the blend amount (described in subparagraph
(B)).
(B)(i) The blend amount for a cost reporting period is the
sum of--
(I) the cost proportion (as defined in clause
(ii)(I)) of the amount described in subparagraph
(A)(i), and
(II) the ASC proportion (as defined in clause
(ii)(II)) of the standard overhead amount payable with
respect to the same surgical procedure as if it were
provided in an ambulatory surgical center in the same
area, as determined under paragraph (2)(A), less the
amount a provider may charge as described in clause
(ii) of section 1866(a)(2)(A).
(ii) Subject to paragraph (4), in this paragraph:
(I) The term ``cost proportion'' means 75 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 42 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(II) The term ``ASC proportion'' means 25 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 58 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(4)(A) In the case of a hospital that--
(i) makes application to the Secretary and
demonstrates that it specializes in eye services or eye
and ear services (as determined by the Secretary),
(ii) receives more than 30 percent of its total
revenues from outpatient services, and
(iii) on October 1, 1987--
(I) was an eye specialty hospital or an eye
and ear specialty hospital, or
(II) was operated as an eye or eye and ear
unit (as defined in subparagraph (B)) of a
general acute care hospital which, on the date
of the application described in clause (i),
operates less than 20 percent of the beds that
the hospital operated on October 1, 1987, and
has sold or otherwise disposed of a substantial
portion of the hospital's other acute care
operations,
the cost proportion and ASC proportion in effect under
subclauses (I) and (II) of paragraph (3)(B)(ii) for cost
reporting periods beginning in fiscal year 1988 shall remain in
effect for cost reporting periods beginning on or after October
1, 1988, and before January 1, 1995.
(B) For purposes of this subparagraph (A)(iii)(II), the term
``eye or eye and ear unit'' means a physically separate or
distinct unit containing separate surgical suites devoted
solely to eye or eye and ear services.
(5)(A) The Secretary is authorized to provide by regulations
that in the case of a surgical procedure, specified by the
Secretary pursuant to paragraph (1)(A), performed in an
ambulatory surgical center described in such paragraph, there
shall be paid (in lieu of any amounts otherwise payable under
this part) with respect to the facility services furnished by
such center and with respect to all related services (including
physicians' services, laboratory, X-ray, and diagnostic
services) a single all-inclusive fee established pursuant to
subparagraph (B), if all parties furnishing all such services
agree to accept such fee (to be divided among the parties
involved in such manner as they shall have previously agreed
upon) as full payment for the services furnished.
(B) In implementing this paragraph, the Secretary shall
establish with respect to each surgical procedure specified
pursuant to paragraph (1)(A) the amount of the all-inclusive
fee for such procedure, taking into account such factors as may
be appropriate. The amount so established with respect to any
surgical procedure shall be reviewed periodically and may be
adjusted by the Secretary, when appropriate, to take account of
varying conditions in different areas.
(6) Any person, including a facility having an agreement
under section 1832(a)(2)(F)(i), who knowingly and willfully
presents, or causes to be presented, a bill or request for
payment, for an intraocular lens inserted during or subsequent
to cataract surgery for which payment may be made under
paragraph (2)(A)(iii), is subject to a civil money penalty of
not to exceed $2,000. The provisions of section 1128A (other
than subsections (a) and (b)) shall apply to a civil money
penalty under the previous sentence in the same manner as such
provisions apply to a penalty or proceeding under section
1128A(a).
(7)(A) For purposes of paragraph (2)(D)(iv), the Secretary
may provide, in the case of an ambulatory surgical center that
does not submit, to the Secretary in accordance with this
paragraph, data required to be submitted on measures selected
under this paragraph with respect to a year, any annual
increase provided under the system established under paragraph
(2)(D) for such year shall be reduced by 2.0 percentage points.
A reduction under this subparagraph shall apply only with
respect to the year involved and the Secretary shall not take
into account such reduction in computing any annual increase
factor for a subsequent year.
(B) Except as the Secretary may otherwise provide, the
provisions of subparagraphs (B), (C), (D), and (E) of paragraph
(17) of section 1833(t) shall apply with respect to services of
ambulatory surgical centers under this paragraph in a similar
manner to the manner in which they apply under such paragraph
and, for purposes of this subparagraph, any reference to a
hospital, outpatient setting, or outpatient hospital services
is deemed a reference to an ambulatory surgical center, the
setting of such a center, or services of such a center,
respectively.
(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including
the second sentence of subparagraph (C) of such paragraph, to
payment for services under this subsection, and make such
revisions under this paragraph, in an appropriate manner (as
determined by the Secretary).
(j) Whenever a final determination is made that the amount of
payment made under this part either to a provider of services
or to another person pursuant to an assignment under section
1842(b)(3)(B)(ii) was in excess of or less than the amount of
payment that is due, and payment of such excess or deficit is
not made (or effected by offset) within 30 days of the date of
the determination, interest shall accrue on the balance of such
excess or deficit not paid or offset (to the extent that the
balance is owed by or owing to the provider) at a rate
determined in accordance with the regulations of the Secretary
of the Treasury applicable to charges for late payments (or, in
the case of such a determination made with respect to a payment
made on or after the date of the enactment of the CARES Act and
during the period at the end of the emergency sentence
described in section 1135(g)(1)(B) under the program described
in section 421.214 of title 42, Code of Federal Regulations (or
any successor regulation), at a rate of 4 percent).
(k) With respect to services described in section
1861(s)(10)(B), the Secretary may provide, instead of the
amount of payment otherwise provided under this part, for
payment of such an amount or amounts as reasonably reflects the
general cost of efficiently providing such services.
(l)(1)(A) The Secretary shall establish a fee schedule for
services of certified registered nurse anesthetists under
section 1861(s)(11).
(B) In establishing the fee schedule under this paragraph the
Secretary may utilize a system of time units, a system of base
and time units, or any appropriate methodology.
(C) The provisions of this subsection shall not apply to
certain services furnished in certain hospitals in rural areas
under the provisions of section 9320(k) of the Omnibus Budget
Reconciliation Act of 1986, as amended by section 6132 of the
Omnibus Budget Reconciliation Act of 1989.
(2) Except as provided in paragraph (3), the fee schedule
established under paragraph (1) shall be initially based on
audited data from cost reporting periods ending in fiscal year
1985 and such other data as the Secretary determines necessary.
(3)(A) In establishing the initial fee schedule for those
services, the Secretary shall adjust the fee schedule to the
extent necessary to ensure that the estimated total amount
which will be paid under this title for those services plus
applicable coinsurance in 1989 will equal the estimated total
amount which would be paid under this title for those services
in 1989 if the services were included as inpatient hospital
services and payment for such services was made under part A in
the same manner as payment was made in fiscal year 1987,
adjusted to take into account changes in prices and technology
relating to the administration of anesthesia.
(B) The Secretary shall also reduce the prevailing charge of
physicians for medical direction of a certified registered
nurse anesthetist, or the fee schedule for services of
certified registered nurse anesthetists, or both, to the extent
necessary to ensure that the estimated total amount which will
be paid under this title plus applicable coinsurance for such
medical direction and such services in 1989 and 1990 will not
exceed the estimated total amount which would have been paid
plus applicable coinsurance but for the enactment of the
amendments made by section 9320 of the Omnibus Budget
Reconciliation Act of 1986. A reduced prevailing charge under
this subparagraph shall become the prevailing charge but for
subsequent years for purposes of applying the economic index
under the fourth sentence of section 1842(b)(3).
(4)(A) Except as provided in subparagraphs (C) and (D), in
determining the amount paid under the fee schedule under this
subsection for services furnished on or after January 1, 1991,
by a certified registered nurse anesthetist who is not
medically directed--
(i) the conversion factor shall be--
(I) for services furnished in 1991, $15.50,
(II) for services furnished in 1992, $15.75,
(III) for services furnished in 1993, $16.00,
(IV) for services furnished in 1994, $16.25,
(V) for services furnished in 1995, $16.50,
(VI) for services furnished in 1996, $16.75,
and
(VII) for services furnished in calendar
years after 1996, the previous year's
conversion factor increased by the update
determined under section 1848(d) for physician
anesthesia services for that year;
(ii) the payment areas to be used shall be the fee
schedule areas used under section 1848 (or, in the case
of services furnished during 1991, the localities used
under section 1842(b)) for purposes of computing
payments for physicians' services that are anesthesia
services;
(iii) the geographic adjustment factors to be applied
to the conversion factor under clause (i) for services
in a fee schedule area or locality is--
(I) in the case of services furnished in
1991, the geographic work index value and the
geographic practice cost index value specified
in section 1842(q)(1)(B) for physicians'
services that are anesthesia services furnished
in the area or locality, and
(II) in the case of services furnished after
1991, the geographic work index value, the
geographic practice cost index value, and the
geographic malpractice index value used for
determining payments for physicians' services
that are anesthesia services under section
1848,
with 70 percent of the conversion factor treated as
attributable to work and 30 percent as attributable to
overhead for services furnished in 1991 (and the
portions attributable to work, practice expenses, and
malpractice expenses in 1992 and thereafter being the
same as is applied under section 1848).
(B)(i) Except as provided in clause (ii) and subparagraph
(D), in determining the amount paid under the fee schedule
under this subsection for services furnished on or after
January 1, 1991, and before January 1, 1994, by a certified
registered nurse anesthetist who is medically directed, the
Secretary shall apply the same methodology specified in
subparagraph (A).
(ii) The conversion factor used under clause (i) shall be--
(I) for services furnished in 1991, $10.50,
(II) for services furnished in 1992, $10.75, and
(III) for services furnished in 1993, $11.00.
(iii) In the case of services of a certified registered nurse
anesthetist who is medically directed or medically supervised
by a physician which are furnished on or after January 1, 1994,
the fee schedule amount shall be one-half of the amount
described in section 1848(a)(5)(B) with respect to the
physician.
(C) Notwithstanding subclauses (I) through (V) of
subparagraph (A)(i)--
(i) in the case of a 1990 conversion factor that is
greater than $16.50, the conversion factor for a
calendar year after 1990 and before 1996 shall be the
1990 conversion factor reduced by the product of the
last digit of the calendar year and one-fifth of the
amount by which the 1990 conversion factor exceeds
$16.50; and
(ii) in the case of a 1990 conversion factor that is
greater than $15.49 but less than $16.51, the
conversion factor for a calendar year after 1990 and
before 1996 shall be the greater of--
(I) the 1990 conversion factor, or
(II) the conversion factor specified in
subparagraph (A)(i) for the year involved.
(D) Notwithstanding subparagraph (C), in no case may the
conversion factor used to determine payment for services in a
fee schedule area or locality under this subsection, as
adjusted by the adjustment factors specified in subparagraphs
(A)(iii), exceed the conversion factor used to determine the
amount paid for physicians' services that are anesthesia
services in the area or locality.
(5)(A) Payment for the services of a certified registered
nurse anesthetist (for which payment may otherwise be made
under this part) may be made on the basis of a claim or request
for payment presented by the certified registered nurse
anesthetist furnishing such services, or by a hospital,
critical access hospital, physician, group practice, or
ambulatory surgical center with which the certified registered
nurse anesthetist furnishing such services has an employment or
contractual relationship that provides for payment to be made
under this part for such services to such hospital, critical
access hospital, physician, group practice, or ambulatory
surgical center.
(B) No hospital or critical access hospital that presents a
claim or request for payment for services of a certified nurse
anesthetist under this part may treat any uncollected
coinsurance amount imposed under this part with respect to such
services as a bad debt of such hospital or critical access
hospital for purposes of this title.
(6) If an adjustment under paragraph (3)(B) results in a
reduction in the reasonable charge for a physicians' service
and a nonparticipating physician furnishes the service to an
individual entitled to benefits under this part after the
effective date of the reduction, the physician's actual charge
is subject to a limit under section 1842(j)(1)(D).
(m)(1) In the case of physicians' services 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.
(2) For each health professional shortage area identified in
paragraph (1) that consists of an entire county, the Secretary
shall provide for the additional payment under paragraph (1)
without any requirement on the physician to identify the health
professional shortage area involved. The Secretary may
implement the previous sentence using the method specified in
subsection (u)(4)(C).
(3) The Secretary shall post on the Internet website of the
Centers for Medicare & Medicaid Services a list of the health
professional shortage areas identified in paragraph (1) that
consist of a partial county to facilitate the additional
payment under paragraph (1) in such areas.
(4) There shall be no administrative or judicial review under
section 1869, section 1878, or otherwise, respecting--
(A) the identification of a county or area;
(B) the assignment of a specialty of any physician
under this paragraph;
(C) the assignment of a physician to a county under
this subsection; or
(D) the assignment of a postal ZIP Code to a county
or other area under this subsection.
(n)(1)(A) The aggregate amount of the payments to be made for
all or part of a cost reporting period for services described
in subsection (a)(2)(E)(i) furnished under this part on or
after October 1, 1988, and before January 1, 1999, and for
services described in subsection (a)(2)(E)(ii) furnished under
this part on or after October 1, 1989, and before January 1,
1999, shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B), or
(ii) the blend amount for radiology services and
diagnostic procedures determined in accordance with
subparagraph (B).
(B)(i) The blend amount for radiology services and diagnostic
procedures for a cost reporting period is the sum of--
(I) the cost proportion (as defined in clause (ii))
of the amount described in subparagraph (A)(i); and
(II) the charge proportion (as defined in clause
(ii)(II)) of 62 percent (for services described in
subsection (a)(2)(E)(i)), or (for procedures described
in subsection (a)(2)(E)(ii)), 42 percent or such other
percent established by the Secretary (or carriers
acting pursuant to guidelines issued by the Secretary)
based on prevailing charges established with actual
charge data, of the prevailing charge or (for services
described in subsection (a)(2)(E)(i) furnished on or
after January 1, 1989) the fee schedule amount
established for participating physicians for the same
services as if they were furnished in a physician's
office in the same locality as determined under section
1842(b), less the amount a provider may charge as
described in clause (ii) of section 1866(a)(2)(A).
(ii) In this subparagraph:
(I) The term ``cost proportion'' means 50 percent,
except that such term means 65 percent in the case of
outpatient radiology services for portions of cost
reporting periods which occur in fiscal year 1989 and
in the case of diagnostic procedures described in
subsection (a)(2)(E)(ii) for portions of cost reporting
periods which occur in fiscal year 1990, and such term
means 42 percent in the case of outpatient radiology
services for portions of cost reporting periods
beginning on or after January 1, 1991.
(II) The term ``charge proportion'' means 100 percent
minus the cost proportion.
(o)(1) In the case of shoes described in section
1861(s)(12)--
(A) no payment may be made under this part, with
respect to any individual for any year, for the
furnishing of--
(i) more than one pair of custom molded shoes
(including inserts provided with such shoes)
and 2 additional pairs of inserts for such
shoes, or
(ii) more than one pair of extra-depth shoes
(not including inserts provided with such
shoes) and 3 pairs of inserts for such shoes,
and
(B) with respect to expenses incurred in any calendar
year, no more than the amount of payment applicable
under paragraph (2) shall be considered as incurred
expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be
considered to include payment for any expenses for the fitting
of such shoes (or inserts).
(2)(A) Except as provided by the Secretary under
subparagraphs (B) and (C), the amount of payment under this
paragraph for custom molded shoes, extra-depth shoes, and
inserts shall be the amount determined for such items by the
Secretary under section 1834(h).
(B) The Secretary may establish payment amounts for shoes and
inserts that are lower than the amount established under
section 1834(h) if the Secretary finds that shoes and inserts
of an appropriate quality are readily available at or below the
amount established under such section.
(C) In accordance with procedures established by the
Secretary, an individual entitled to benefits with respect to
shoes described in section 1861(s)(12) may substitute
modification of such shoes instead of obtaining one (or more,
as specified by the Secretary) pair of inserts (other than the
original pair of inserts with respect to such shoes). In such
case, the Secretary shall substitute, for the payment amount
established under section 1834(h), a payment amount that the
Secretary estimates will assure that there is no net increase
in expenditures under this subsection as a result of this
subparagraph.
(3) In this title, the term ``shoes'' includes, except for
purposes of subparagraphs (A)(ii) and (B) of paragraph (2),
inserts for extra-depth shoes.
(q)(1) Each request for payment, or bill submitted, for an
item or service furnished by an entity for which payment may be
made under this part and for which the entity knows or has
reason to believe there has been a referral by a referring
physician (within the meaning of section 1877) shall include
the name and unique physician identification number for the
referring physician.
(2)(A) In the case of a request for payment for an item or
service furnished by an entity under this part on an
assignment-related basis and for which information is required
to be provided under paragraph (1) but not included, payment
may be denied under this part.
(B) In the case of a request for payment for an item or
service furnished by an entity under this part not submitted on
an assignment-related basis and for which information is
required to be provided under paragraph (1) but not included--
(i) if the entity knowingly and willfully fails to
provide such information promptly upon request of the
Secretary or a carrier, the entity may be subject to a
civil money penalty in an amount not to exceed $2,000,
and
(ii) if the entity knowingly, willfully, and in
repeated cases fails, after being notified by the
Secretary of the obligations and requirements of this
subsection to provide the information required under
paragraph (1), the entity may be subject to exclusion
from participation in the programs under this Act for a
period not to exceed 5 years, in accordance with the
procedures of subsections (c), (f), and (g) of section
1128.
The provisions of section 1128A (other than subsections (a) and
(b)) shall apply to civil money penalties under clause (i) in
the same manner as they apply to a penalty or proceeding under
section 1128A(a).
(r)(1) With respect to services described in section
1861(s)(2)(K)(ii) (relating to nurse practitioner or clinical
nurse specialist services), payment may be made on the basis of
a claim or request for payment presented by the nurse
practitioner or clinical nurse specialist furnishing such
services, or by a hospital, critical access hospital, skilled
nursing facility or nursing facility (as defined in section
1919(a)), physician, group practice, or ambulatory surgical
center with which the nurse practitioner or clinical nurse
specialist has an employment or contractual relationship that
provides for payment to be made under this part for such
services to such hospital, physician, group practice, or
ambulatory surgical center.
(2) No hospital or critical access hospital that presents a
claim or request for payment under this part for services
described in section 1861(s)(2)(K)(ii) may treat any
uncollected coinsurance amount imposed under this part with
respect to such services as a bad debt of such hospital for
purposes of this title.
(s) The Secretary may not provide for payment under
subsection (a)(1)(A) with respect to an organization unless the
organization provides assurances satisfactory to the Secretary
that the organization meets the requirement of section 1866(f)
(relating to maintaining written policies and procedures
respecting advance directives).
(t) Prospective Payment System for Hospital Outpatient
Department Services.--
(1) Amount of payment.--
(A) In general.--With respect to covered OPD
services (as defined in subparagraph (B))
furnished during a year beginning with 1999,
the amount of payment under this part shall be
determined under a prospective payment system
established by the Secretary in accordance with
this subsection.
(B) Definition of covered opd services.--For
purposes of this subsection, the term ``covered
OPD services''--
(i) means hospital outpatient
services designated by the Secretary;
(ii) subject to clause (iv), includes
inpatient hospital services designated
by the Secretary that are covered under
this part and furnished to a hospital
inpatient who (I) is entitled to
benefits under part A but has exhausted
benefits for inpatient hospital
services during a spell of illness, or
(II) is not so entitled;
(iii) includes implantable items
described in paragraph (3), (6), or (8)
of section 1861(s);
(iv) does not include any therapy
services described in subsection (a)(8)
or ambulance services, for which
payment is made under a fee schedule
described in section 1834(k) or section
1834(l) and does not include screening
mammography (as defined in section
1861(jj)), diagnostic mammography, or
personalized prevention plan services
(as defined in section 1861(hhh)(1));
and
(v) does not include applicable items
and services (as defined in
subparagraph (A) of paragraph (21))
that are furnished on or after January
1, 2017, by an off-campus outpatient
department of a provider (as defined in
subparagraph (B) of such paragraph).
(2) System requirements.--Under the payment system--
(A) the Secretary shall develop a
classification system for covered OPD services;
(B) the Secretary may establish groups of
covered OPD services, within the classification
system described in subparagraph (A), so that
services classified within each group are
comparable clinically and with respect to the
use of resources and so that an implantable
item is classified to the group that includes
the service to which the item relates;
(C) the Secretary shall, using data on claims
from 1996 and using data from the most recent
available cost reports, establish relative
payment weights for covered OPD services (and
any groups of such services described in
subparagraph (B)) based on median (or, at the
election of the Secretary, mean) hospital costs
and shall determine projections of the
frequency of utilization of each such service
(or group of services) in 1999;
(D) subject to paragraph (19), the Secretary
shall determine a wage adjustment factor to
adjust the portion of payment and coinsurance
attributable to labor-related costs for
relative differences in labor and labor-related
costs across geographic regions in a budget
neutral manner;
(E) the Secretary shall establish, in a
budget neutral manner, outlier adjustments
under paragraph (5) and transitional pass-
through payments under paragraph (6) and other
adjustments as determined to be necessary to
ensure equitable payments, such as adjustments
for certain classes of hospitals;
(F) the Secretary shall develop a method for
controlling unnecessary increases in the volume
of covered OPD services;
(G) the Secretary shall create additional
groups of covered OPD services that classify
separately those procedures that utilize
contrast agents from those that do not; and
(H) with respect to devices of brachytherapy
consisting of a seed or seeds (or radioactive
source), the Secretary shall create additional
groups of covered OPD services that classify
such devices separately from the other services
(or group of services) paid for under this
subsection in a manner reflecting the number,
isotope, and radioactive intensity of such
devices furnished, including separate groups
for palladium-103 and iodine-125 devices and
for stranded and non-stranded devices furnished
on or after July 1, 2007.
For purposes of subparagraph (B), items and services
within a group shall not be treated as ``comparable
with respect to the use of resources'' if the highest
median cost (or mean cost, if elected by the Secretary
under subparagraph (C)) for an item or service within
the group is more than 2 times greater than the lowest
median cost (or mean cost, if so elected) for an item
or service within the group; except that the Secretary
may make exceptions in unusual cases, such as low
volume items and services, but may not make such an
exception in the case of a drug or biological that has
been designated as an orphan drug under section 526 of
the Federal Food, Drug and Cosmetic Act.
(3) Calculation of base amounts.--
(A) Aggregate amounts that would be payable
if deductibles were disregarded.--The Secretary
shall estimate the sum of--
(i) the total amounts that would be
payable from the Trust Fund under this
part for covered OPD services in 1999,
determined without regard to this
subsection, as though the deductible
under section 1833(b) did not apply,
and
(ii) the total amounts of copayments
estimated to be paid under this
subsection by beneficiaries to
hospitals for covered OPD services in
1999, as though the deductible under
section 1833(b) did not apply.
(B) Unadjusted copayment amount.--
(i) In general.--For purposes of this
subsection, subject to clause (ii), the
``unadjusted copayment amount''
applicable to a covered OPD service (or
group of such services) is 20 percent
of the national median of the charges
for the service (or services within the
group) furnished during 1996, updated
to 1999 using the Secretary's estimate
of charge growth during the period.
(ii) Adjusted to be 20 percent when
fully phased in.--If the pre-deductible
payment percentage for a covered OPD
service (or group of such services)
furnished in a year would be equal to
or exceed 80 percent, then the
unadjusted copayment amount shall be 20
percent of amount determined under
subparagraph (D).
(iii) Rules for new services.--The
Secretary shall establish rules for
establishment of an unadjusted
copayment amount for a covered OPD
service not furnished during 1996,
based upon its classification within a
group of such services.
(C) Calculation of conversion factors.--
(i) For 1999.--
(I) In general.--The
Secretary shall establish a
1999 conversion factor for
determining the medicare OPD
fee schedule amounts for each
covered OPD service (or group
of such services) furnished in
1999. Such conversion factor
shall be established on the
basis of the weights and
frequencies described in
paragraph (2)(C) and in such a
manner that the sum for all
services and groups of the
products (described in
subclause (II) for each such
service or group) equals the
total projected amount
described in subparagraph (A).
(II) Product described.--The
Secretary shall determine for
each service or group the
product of the medicare OPD fee
schedule amounts (taking into
account appropriate adjustments
described in paragraphs (2)(D)
and (2)(E)) and the estimated
frequencies for such service or
group.
(ii) Subsequent years.--Subject to
paragraph (8)(B), the Secretary shall
establish a conversion factor for
covered OPD services furnished in
subsequent years in an amount equal to
the conversion factor established under
this subparagraph and applicable to
such services furnished in the previous
year increased by the OPD fee schedule
increase factor specified under clause
(iv) for the year involved.
(iii) Adjustment for service mix
changes.--Insofar as the Secretary
determines that the adjustments for
service mix under paragraph (2) for a
previous year (or estimates that such
adjustments for a future year) did (or
are likely to) result in a change in
aggregate payments under this
subsection during the year that are a
result of changes in the coding or
classification of covered OPD services
that do not reflect real changes in
service mix, the Secretary may adjust
the conversion factor computed under
this subparagraph for subsequent years
so as to eliminate the effect of such
coding or classification changes.
(iv) OPD fee schedule increase
factor.--For purposes of this
subparagraph, subject to paragraph (17)
and subparagraph (F) of this paragraph,
the ``OPD fee schedule increase
factor'' for services furnished in a
year is equal to the market basket
percentage increase applicable under
section 1886(b)(3)(B)(iii) to hospital
discharges occurring during the fiscal
year ending in such year, reduced by 1
percentage point for such factor for
services furnished in each of 2000 and
2002. In applying the previous sentence
for years beginning with 2000, the
Secretary may substitute for the market
basket percentage increase an annual
percentage increase that is computed
and applied with respect to covered OPD
services furnished in a year in the
same manner as the market basket
percentage increase is determined and
applied to inpatient hospital services
for discharges occurring in a fiscal
year.
(D) Calculation of medicare opd fee schedule
amounts.--The Secretary shall compute a
medicare OPD fee schedule amount for each
covered OPD service (or group of such services)
furnished in a year, in an amount equal to the
product of--
(i) the conversion factor computed
under subparagraph (C) for the year,
and
(ii) the relative payment weight
(determined under paragraph (2)(C)) for
the service or group.
(E) Pre-deductible payment percentage.--The
pre-deductible payment percentage for a covered
OPD service (or group of such services)
furnished in a year is equal to the ratio of--
(i) the medicare OPD fee schedule
amount established under subparagraph
(D) for the year, minus the unadjusted
copayment amount determined under
subparagraph (B) for the service or
group, to
(ii) the medicare OPD fee schedule
amount determined under subparagraph
(D) for the year for such service or
group.
(F) Productivity and other adjustment.--After
determining the OPD fee schedule increase
factor under subparagraph (C)(iv), the
Secretary shall reduce such increase factor--
(i) for 2012 and subsequent years, by
the productivity adjustment described
in section 1886(b)(3)(B)(xi)(II); and
(ii) for each of 2010 through 2019,
by the adjustment described in
subparagraph (G).
The application of this subparagraph may result
in the increase factor under subparagraph
(C)(iv) being less than 0.0 for a year, and may
result in payment rates under the payment
system under this subsection for a year being
less than such payment rates for the preceding
year.
(G) Other adjustment.--For purposes of
subparagraph (F)(ii), the adjustment described
in this subparagraph is--
(i) for each of 2010 and 2011, 0.25
percentage point;
(ii) for each of 2012 and 2013, 0.1
percentage point;
(iii) for 2014, 0.3 percentage point;
(iv) for each of 2015 and 2016, 0.2
percentage point; and
(v) for each of 2017, 2018, and 2019,
0.75 percentage point.
(4) Medicare payment amount.--The amount of payment
made from the Trust Fund under this part for a covered
OPD service (and such services classified within a
group) furnished in a year is determined, subject to
paragraph (7), as follows:
(A) Fee schedule adjustments.--The medicare
OPD fee schedule amount (computed under
paragraph (3)(D)) for the service or group and
year is adjusted for relative differences in
the cost of labor and other factors determined
by the Secretary, as computed under paragraphs
(2)(D) and (2)(E).
(B) Subtract applicable deductible.--Reduce
the adjusted amount determined under
subparagraph (A) by the amount of the
deductible under section 1833(b), to the extent
applicable.
(C) Apply payment proportion to remainder.--
The amount of payment is the amount so
determined under subparagraph (B) multiplied by
the pre-deductible payment percentage (as
determined under paragraph (3)(E)) for the
service or group and year involved, plus the
amount of any reduction in the copayment amount
attributable to paragraph (8)(C).
(5) Outlier adjustment.--
(A) In general.--Subject to subparagraph (D),
the Secretary shall provide for an additional
payment for each covered OPD service (or group
of services) for which a hospital's charges,
adjusted to cost, exceed--
(i) a fixed multiple of the sum of--
(I) the applicable medicare
OPD fee schedule amount
determined under paragraph
(3)(D), as adjusted under
paragraph (4)(A) (other than
for adjustments under this
paragraph or paragraph (6));
and
(II) any transitional pass-
through payment under paragraph
(6); and
(ii) at the option of the Secretary,
such fixed dollar amount as the
Secretary may establish.
(B) Amount of adjustment.--The amount of the
additional payment under subparagraph (A) shall
be determined by the Secretary and shall
approximate the marginal cost of care beyond
the applicable cutoff point under such
subparagraph.
(C) Limit on aggregate outlier adjustments.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means a
percentage specified by the Secretary
up to (but not to exceed)--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
3.0 percent.
(D) Transitional authority.--In applying
subparagraph (A) for covered OPD services
furnished before January 1, 2002, the Secretary
may--
(i) apply such subparagraph to a bill
for such services related to an
outpatient encounter (rather than for a
specific service or group of services)
using OPD fee schedule amounts and
transitional pass-through payments
covered under the bill; and
(ii) use an appropriate cost-to-
charge ratio for the hospital involved
(as determined by the Secretary),
rather than for specific departments
within the hospital.
(E) Exclusion of separate drug and biological
apcs from outlier payments.--No additional
payment shall be made under subparagraph (A) in
the case of ambulatory payment classification
groups established separately for drugs or
biologicals.
(6) Transitional pass-through for additional costs of
innovative medical devices, drugs, and biologicals.--
(A) In general.--The Secretary shall provide
for an additional payment under this paragraph
for any of the following that are provided as
part of a covered OPD service (or group of
services):
(i) Current orphan drugs.--A drug or
biological that is used for a rare
disease or condition with respect to
which the drug or biological has been
designated as an orphan drug under
section 526 of the Federal Food, Drug
and Cosmetic Act if payment for the
drug or biological as an outpatient
hospital service under this part was
being made on the first date that the
system under this subsection is
implemented.
(ii) Current cancer therapy drugs and
biologicals and brachytherapy.--A drug
or biological that is used in cancer
therapy, including (but not limited to)
a chemotherapeutic agent, an
antiemetic, a hematopoietic growth
factor, a colony stimulating factor, a
biological response modifier, a
bisphosphonate, and a device of
brachytherapy or temperature monitored
cryoablation, if payment for such drug,
biological, or device as an outpatient
hospital service under this part was
being made on such first date.
(iii) Current radiopharmaceutical
drugs and biological products.--A
radiopharmaceutical drug or biological
product used in diagnostic, monitoring,
and therapeutic nuclear medicine
procedures if payment for the drug or
biological as an outpatient hospital
service under this part was being made
on such first date.
(iv) New medical devices, drugs, and
biologicals.--A medical device, drug,
or biological not described in clause
(i), (ii), or (iii) if--
(I) payment for the device,
drug, or biological as an
outpatient hospital service
under this part was not being
made as of December 31, 1996;
and
(II) the cost of the drug or
biological or the average cost
of the category of devices is
not insignificant in relation
to the OPD fee schedule amount
(as calculated under paragraph
(3)(D)) payable for the service
(or group of services)
involved.
(B) Use of categories in determining
eligibility of a device for pass-through
payments.--The following provisions apply for
purposes of determining whether a medical
device qualifies for additional payments under
clause (ii) or (iv) of subparagraph (A):
(i) Establishment of initial
categories.--
(I) In general.--The
Secretary shall initially
establish under this clause
categories of medical devices
based on type of device by
April 1, 2001. Such categories
shall be established in a
manner such that each medical
device that meets the
requirements of clause (ii) or
(iv) of subparagraph (A) as of
January 1, 2001, is included in
such a category and no such
device is included in more than
one category. For purposes of
the preceding sentence, whether
a medical device meets such
requirements as of such date
shall be determined on the
basis of the program memoranda
issued before such date.
(II) Authorization of
implementation other than
through regulations.--The
categories may be established
under this clause by program
memorandum or otherwise, after
consultation with groups
representing hospitals,
manufacturers of medical
devices, and other affected
parties.
(ii) Establishing criteria for
additional categories.--
(I) In general.--The
Secretary shall establish
criteria that will be used for
creation of additional
categories (other than those
established under clause (i))
through rulemaking (which may
include use of an interim final
rule with comment period).
(II) Standard.--Such
categories shall be established
under this clause in a manner
such that no medical device is
described by more than one
category. Such criteria shall
include a test of whether the
average cost of devices that
would be included in a category
and are in use at the time the
category is established is not
insignificant, as described in
subparagraph (A)(iv)(II).
(III) Deadline.--Criteria
shall first be established
under this clause by July 1,
2001. The Secretary may
establish in compelling
circumstances categories under
this clause before the date
such criteria are established.
(IV) Adding categories.--The
Secretary shall promptly
establish a new category of
medical devices under this
clause for any medical device
that meets the requirements of
subparagraph (A)(iv) and for
which none of the categories in
effect (or that were previously
in effect) is appropriate.
(iii) Period for which category is in
effect.--A category of medical devices
established under clause (i) or (ii)
shall be in effect for a period of at
least 2 years, but not more than 3
years, that begins--
(I) in the case of a category
established under clause (i),
on the first date on which
payment was made under this
paragraph for any device
described by such category
(including payments made during
the period before April 1,
2001); and
(II) in the case of any other
category, on the first date on
which payment is made under
this paragraph for any medical
device that is described by
such category.
(iv) Requirements treated as met.--A
medical device shall be treated as
meeting the requirements of
subparagraph (A)(iv), regardless of
whether the device meets the
requirement of subclause (I) of such
subparagraph, if--
(I) the device is described
by a category established and
in effect under clause (i); or
(II) the device is described
by a category established and
in effect under clause (ii) and
an application under section
515 of the Federal Food, Drug,
and Cosmetic Act has been
approved with respect to the
device, or the device has been
cleared for market under
section 510(k) of such Act, or
the device is exempt from the
requirements of section 510(k)
of such Act pursuant to
subsection (l) or (m) of
section 510 of such Act or
section 520(g) of such Act.
Nothing in this clause shall be
construed as requiring an application
or prior approval (other than that
described in subclause (II)) in order
for a covered device described by a
category to qualify for payment under
this paragraph.
(C) Limited period of payment.--
(i) Drugs and biologicals.--Subject
to subparagraph (G), the payment under
this paragraph with respect to a drug
or biological shall only apply during a
period of at least 2 years, but not
more than 3 years, that begins--
(I) on the first date this
subsection is implemented in
the case of a drug or
biological described in clause
(i), (ii), or (iii) of
subparagraph (A) and in the
case of a drug or biological
described in subparagraph
(A)(iv) and for which payment
under this part is made as an
outpatient hospital service
before such first date; or
(II) in the case of a drug or
biological described in
subparagraph (A)(iv) not
described in subclause (I), on
the first date on which payment
is made under this part for the
drug or biological as an
outpatient hospital service.
(ii) Medical devices.--Payment shall
be made under this paragraph with
respect to a medical device only if
such device--
(I) is described by a
category of medical devices
established and in effect under
subparagraph (B); and
(II) is provided as part of a
service (or group of services)
paid for under this subsection
and provided during the period
for which such category is in
effect under such subparagraph.
(D) Amount of additional payment.--Subject to
subparagraph (E)(iii), the amount of the
payment under this paragraph with respect to a
device, drug, or biological provided as part of
a covered OPD service is--
(i) subject to subparagraph (H), in
the case of a drug or biological, the
amount by which the amount determined
under section 1842(o) (or if the drug
or biological is covered under a
competitive acquisition contract under
section 1847B, an amount determined by
the Secretary equal to the average
price for the drug or biological for
all competitive acquisition areas and
year established under such section as
calculated and adjusted by the
Secretary for purposes of this
paragraph) for the drug or biological
exceeds the portion of the otherwise
applicable medicare OPD fee schedule
that the Secretary determines is
associated with the drug or biological;
or
(ii) in the case of a medical device,
the amount by which the hospital's
charges for the device, adjusted to
cost, exceeds the portion of the
otherwise applicable medicare OPD fee
schedule that the Secretary determines
is associated with the device.
(E) Limit on aggregate annual adjustment.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year. This clause
shall not apply for 2018 or 2020.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
a percentage specified by the
Secretary up to (but not to
exceed) 2.0 percent.
(iii) Uniform prospective reduction
if aggregate limit projected to be
exceeded.--If the Secretary estimates
before the beginning of a year that the
amount of the additional payments under
this paragraph for the year (or portion
thereof) as determined under clause (i)
without regard to this clause will
exceed the limit established under such
clause, the Secretary shall reduce pro
rata the amount of each of the
additional payments under this
paragraph for that year (or portion
thereof) in order to ensure that the
aggregate additional payments under
this paragraph (as so estimated) do not
exceed such limit.
(F) Limitation of application of functional
equivalence standard.--
(i) In general.--The Secretary may
not publish regulations that apply a
functional equivalence standard to a
drug or biological under this
paragraph.
(ii) Application.--Clause (i) shall
apply to the application of a
functional equivalence standard to a
drug or biological on or after the date
of enactment of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 unless--
(I) such application was
being made to such drug or
biological prior to such date
of enactment; and
(II) the Secretary applies
such standard to such drug or
biological only for the purpose
of determining eligibility of
such drug or biological for
additional payments under this
paragraph and not for the
purpose of any other payments
under this title.
(iii) Rule of construction.--Nothing
in this subparagraph shall be construed
to effect the Secretary's authority to
deem a particular drug to be identical
to another drug if the 2 products are
pharmaceutically equivalent and
bioequivalent, as determined by the
Commissioner of Food and Drugs.
(G) Pass-through extension for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, such pass-
through status shall be extended for a 2-year
period beginning on October 1, 2018.
(H) Temporary payment rule for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, the
payment amount for such drug or biological
under this subsection that is furnished during
the period beginning on October 1, 2018, and
ending on March 31, 2019, shall be the greater
of--
(i) the payment amount that would
otherwise apply under subparagraph
(D)(i) for such drug or biological
during such period; or
(ii) the payment amount that applied
under such subparagraph (D)(i) for such
drug or biological on December 31,
2017.
(I) Special payment adjustment rules for last
quarter of 2018.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment amount
for a covered OPD service (or group of
services) beginning January 1, 2018, the
following rules shall apply with respect to
payment amounts under this subsection for
covered a OPD service (or group of services)
furnished during the period beginning on
October 1, 2018, and ending on December 31,
2018:
(i) The Secretary shall remove the
packaged costs of such drug or
biological (as determined by the
Secretary) from the payment amount
under this subsection for the covered
OPD service (or group of services) with
which it is packaged.
(ii) The Secretary shall not make any
adjustments to payment amounts under
this subsection for a covered OPD
service (or group of services) for
which no costs were removed under
clause (i).
(J) Additional pass-through extension and
special payment adjustment rule for certain
diagnostic radiopharmaceuticals.--In the case
of a drug or biological furnished in the
context of a clinical study on diagnostic
imaging tests approved under a coverage with
evidence development determination whose period
of pass-through status under this paragraph
concluded on December 31, 2018, and for which
payment under this subsection was packaged into
a payment for a covered OPD service (or group
of services) furnished beginning January 1,
2019, the Secretary shall--
(i) extend such pass-through status
for such drug or biological for the 9-
month period beginning on January 1,
2020;
(ii) remove, during such period, the
packaged costs of such drug or
biological (as determined by the
Secretary) from the payment amount
under this subsection for the covered
OPD service (or group of services) with
which it is packaged; and
(iii) not make any adjustments to
payment amounts under this subsection
for a covered OPD service (or group of
services) for which no costs were
removed under clause (ii).
(7) Transitional adjustment to limit decline in
payment.--
(A) Before 2002.--Subject to subparagraph
(D), for covered OPD services furnished before
January 1, 2002, for which the PPS amount (as
defined in subparagraph (E)) is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA amount
(as defined in subparagraph (F)), the
amount of payment under this subsection
shall be increased by 80 percent of the
amount of such difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.71
and the pre-BBA amount, exceeds (II)
the product of 0.70 and the PPS amount;
(iii) at least 70 percent, but less
than 80 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.63
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iv) less than 70 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by
21 percent of the pre-BBA amount.
(B) 2002.--Subject to subparagraph (D), for
covered OPD services furnished during 2002, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
70 percent of the amount of such
difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.61
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iii) less than 80 percent of the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by 13 percent of the pre-BBA
amount.
(C) 2003.--Subject to subparagraph (D), for
covered OPD services furnished during 2003, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
60 percent of the amount of such
difference; or
(ii) less than 90 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by 6
percent of the pre-BBA amount.
(D) Hold harmless provisions.--
(i) Temporary treatment for certain
rural hospitals.--(I) In the case of a
hospital located in a rural area and
that has not more than 100 beds or a
sole community hospital (as defined in
section 1886(d)(5)(D)(iii)) located in
a rural area, for covered OPD services
furnished before January 1, 2006, for
which the PPS amount is less than the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by the amount of such
difference.
(II) In the case of a hospital
located in a rural area and that has
not more than 100 beds and that is not
a sole community hospital (as defined
in section 1886(d)(5)(D)(iii)), for
covered OPD services furnished on or
after January 1, 2006, and before
January 1, 2013, for which the PPS
amount is less than the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
applicable percentage of the amount of
such difference. For purposes of the
preceding sentence, the applicable
percentage shall be 95 percent with
respect to covered OPD services
furnished in 2006, 90 percent with
respect to such services furnished in
2007, and 85 percent with respect to
such services furnished in 2008, 2009,
2010, 2011, or 2012.
(III) In the case of a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)) that has not more
than 100 beds, for covered OPD services
furnished on or after January 1, 2009,
and before January 1, 2013, for which
the PPS amount is less than the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
85 percent of the amount of such
difference. In the case of covered OPD
services furnished on or after January
1, 2010, and before March 1, 2012, the
preceding sentence shall be applied
without regard to the 100-bed
limitation.
(ii) Permanent treatment for cancer
hospitals and children's hospitals.--In
the case of a hospital described in
clause (iii) or (v) of section
1886(d)(1)(B), for covered OPD services
for which the PPS amount is less than
the pre-BBA amount, the amount of
payment under this subsection shall be
increased by the amount of such
difference.
(E) PPS amount defined.--In this paragraph,
the term ``PPS amount'' means, with respect to
covered OPD services, the amount payable under
this title for such services (determined
without regard to this paragraph), including
amounts payable as copayment under paragraph
(8), coinsurance under section
1866(a)(2)(A)(ii), and the deductible under
section 1833(b).
(F) Pre-BBA amount defined.--
(i) In general.--In this paragraph,
the ``pre-BBA amount'' means, with
respect to covered OPD services
furnished by a hospital in a year, an
amount equal to the product of the
reasonable cost of the hospital for
such services for the portions of the
hospital's cost reporting period (or
periods) occurring in the year and the
base OPD payment-to-cost ratio for the
hospital (as defined in clause (ii)).
(ii) Base payment-to-cost-ratio
defined.--For purposes of this
subparagraph, the ``base payment-to-
cost ratio'' for a hospital means the
ratio of--
(I) the hospital's
reimbursement under this part
for covered OPD services
furnished during the cost
reporting period ending in 1996
(or in the case of a hospital
that did not submit a cost
report for such period, during
the first subsequent cost
reporting period ending before
2001 for which the hospital
submitted a cost report),
including any reimbursement for
such services through cost-
sharing described in
subparagraph (E), to
(II) the reasonable cost of
such services for such period.
The Secretary shall determine such
ratios as if the amendments made by
section 4521 of the Balanced Budget Act
of 1997 were in effect in 1996.
(G) Interim payments.--The Secretary shall
make payments under this paragraph to hospitals
on an interim basis, subject to retrospective
adjustments based on settled cost reports.
(H) No effect on copayments.--Nothing in this
paragraph shall be construed to affect the
unadjusted copayment amount described in
paragraph (3)(B) or the copayment amount under
paragraph (8).
(I) Application without regard to budget
neutrality.--The additional payments made under
this paragraph--
(i) shall not be considered an
adjustment under paragraph (2)(E); and
(ii) shall not be implemented in a
budget neutral manner.
(8) Copayment amount.--
(A) In general.--Except as provided in
subparagraphs (B) and (C), the copayment amount
under this subsection is the amount by which
the amount described in paragraph (4)(B)
exceeds the amount of payment determined under
paragraph (4)(C).
(B) Election to offer reduced copayment
amount.--The Secretary shall establish a
procedure under which a hospital, before the
beginning of a year (beginning with 1999), may
elect to reduce the copayment amount otherwise
established under subparagraph (A) for some or
all covered OPD services to an amount that is
not less than 20 percent of the medicare OPD
fee schedule amount (computed under paragraph
(3)(D)) for the service involved. Under such
procedures, such reduced copayment amount may
not be further reduced or increased during the
year involved and the hospital may disseminate
information on the reduction of copayment
amount effected under this subparagraph.
(C) Limitation on copayment amount.--
(i) To inpatient hospital deductible
amount.--In no case shall the copayment
amount for a procedure performed in a
year exceed the amount of the inpatient
hospital deductible established under
section 1813(b) for that year.
(ii) To specified percentage.--The
Secretary shall reduce the national
unadjusted copayment amount for a
covered OPD service (or group of such
services) furnished in a year in a
manner so that the effective copayment
rate (determined on a national
unadjusted basis) for that service in
the year does not exceed the following
percentage:
(I) For procedures performed
in 2001, on or after April 1,
2001, 57 percent.
(II) For procedures performed
in 2002 or 2003, 55 percent.
(III) For procedures
performed in 2004, 50 percent.
(IV) For procedures performed
in 2005, 45 percent.
(V) For procedures performed
in 2006 and thereafter, 40
percent.
(D) No impact on deductibles.--Nothing in
this paragraph shall be construed as affecting
a hospital's authority to waive the charging of
a deductible under section 1833(b).
(E) Computation ignoring outlier and pass-
through adjustments.--The copayment amount
shall be computed under subparagraph (A) as if
the adjustments under paragraphs (5) and (6)
(and any adjustment made under paragraph (2)(E)
in relation to such adjustments) had not
occurred.
(9) Periodic review and adjustments components of
prospective payment system.--
(A) Periodic review.--The Secretary shall
review not less often than annually and revise
the groups, the relative payment weights, and
the wage and other adjustments described in
paragraph (2) to take into account changes in
medical practice, changes in technology, the
addition of new services, new cost data, and
other relevant information and factors. The
Secretary shall consult with an expert outside
advisory panel composed of an appropriate
selection of representatives of providers to
review (and advise the Secretary concerning)
the clinical integrity of the groups and
weights. Such panel may use data collected or
developed by entities and organizations (other
than the Department of Health and Human
Services) in conducting such review.
(B) Budget neutrality adjustment.--If the
Secretary makes adjustments under subparagraph
(A), then the adjustments for a year may not
cause the estimated amount of expenditures
under this part for the year to increase or
decrease from the estimated amount of
expenditures under this part that would have
been made if the adjustments had not been made.
In determining adjustments under the preceding
sentence for 2004 and 2005, the Secretary shall
not take into account under this subparagraph
or paragraph (2)(E) any expenditures that would
not have been made but for the application of
paragraph (14).
(C) Update factor.--If the Secretary
determines under methodologies described in
paragraph (2)(F) that the volume of services
paid for under this subsection increased beyond
amounts established through those
methodologies, the Secretary may appropriately
adjust the update to the conversion factor
otherwise applicable in a subsequent year.
(10) Special rule for ambulance services.--The
Secretary shall pay for hospital outpatient services
that are ambulance services on the basis described in
section 1861(v)(1)(U), or, if applicable, the fee
schedule established under section 1834(l).
(11) Special rules for certain hospitals.--In the
case of hospitals described in clause (iii) or (v) of
section 1886(d)(1)(B)--
(A) the system under this subsection shall
not apply to covered OPD services furnished
before January 1, 2000; and
(B) the Secretary may establish a separate
conversion factor for such services in a manner
that specifically takes into account the unique
costs incurred by such hospitals by virtue of
their patient population and service intensity.
(12) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise of--
(A) the development of the classification
system under paragraph (2), including the
establishment of groups and relative payment
weights for covered OPD services, of wage
adjustment factors, other adjustments, and
methods described in paragraph (2)(F);
(B) the calculation of base amounts under
paragraph (3);
(C) periodic adjustments made under paragraph
(6);
(D) the establishment of a separate
conversion factor under paragraph (8)(B); and
(E) the determination of the fixed multiple,
or a fixed dollar cutoff amount, the marginal
cost of care, or applicable percentage under
paragraph (5) or the determination of
insignificance of cost, the duration of the
additional payments, the determination and
deletion of initial and new categories
(consistent with subparagraphs (B) and (C) of
paragraph (6)), the portion of the medicare OPD
fee schedule amount associated with particular
devices, drugs, or biologicals, and the
application of any pro rata reduction under
paragraph (6).
(13) Authorization of adjustment for rural
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
located in rural areas by ambulatory payment
classification groups (APCs) exceed those costs
incurred by hospitals located in urban areas.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals located in
rural areas exceed those costs incurred by
hospitals located in urban areas, the Secretary
shall provide for an appropriate adjustment
under paragraph (2)(E) to reflect those higher
costs by January 1, 2006.
(14) Drug apc payment rates.--
(A) In general.--The amount of payment under
this subsection for a specified covered
outpatient drug (defined in subparagraph (B))
that is furnished as part of a covered OPD
service (or group of services)--
(i) in 2004, in the case of--
(I) a sole source drug shall
in no case be less than 88
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug;
(ii) in 2005, in the case of--
(I) a sole source drug shall
in no case be less than 83
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug; or
(iii) in a subsequent year, shall be
equal, subject to subparagraph (E)--
(I) to the average
acquisition cost for the drug
for that year (which, at the
option of the Secretary, may
vary by hospital group (as
defined by the Secretary based
on volume of covered OPD
services or other relevant
characteristics)), as
determined by the Secretary
taking into account the
hospital acquisition cost
survey data under subparagraph
(D); or
(II) if hospital acquisition
cost data are not available,
the average price for the drug
in the year established under
section 1842(o), section 1847A,
or section 1847B, as the case
may be, as calculated and
adjusted by the Secretary as
necessary for purposes of this
paragraph.
(B) Specified covered outpatient drug
defined.--
(i) In general.--In this paragraph,
the term ``specified covered outpatient
drug'' means, subject to clause (ii), a
covered outpatient drug (as defined in
section 1927(k)(2)) for which a
separate ambulatory payment
classification group (APC) has been
established and that is--
(I) a radiopharmaceutical; or
(II) a drug or biological for
which payment was made under
paragraph (6) (relating to
pass-through payments) on or
before December 31, 2002.
(ii) Exception.--Such term does not
include--
(I) a drug or biological for
which payment is first made on
or after January 1, 2003, under
paragraph (6);
(II) a drug or biological for
which a temporary HCPCS code
has not been assigned; or
(III) during 2004 and 2005,
an orphan drug (as designated
by the Secretary).
(C) Payment for designated orphan drugs
during 2004 and 2005.--The amount of payment
under this subsection for an orphan drug
designated by the Secretary under subparagraph
(B)(ii)(III) that is furnished as part of a
covered OPD service (or group of services)
during 2004 and 2005 shall equal such amount as
the Secretary may specify.
(D) Acquisition cost survey for hospital
outpatient drugs.--
(i) Annual gao surveys in 2004 and
2005.--
(I) In general.--The
Comptroller General of the
United States shall conduct a
survey in each of 2004 and 2005
to determine the hospital
acquisition cost for each
specified covered outpatient
drug. Not later than April 1,
2005, the Comptroller General
shall furnish data from such
surveys to the Secretary for
use in setting the payment
rates under subparagraph (A)
for 2006.
(II) Recommendations.--Upon
the completion of such surveys,
the Comptroller General shall
recommend to the Secretary the
frequency and methodology of
subsequent surveys to be
conducted by the Secretary
under clause (ii).
(ii) Subsequent secretarial
surveys.--The Secretary, taking into
account such recommendations, shall
conduct periodic subsequent surveys to
determine the hospital acquisition cost
for each specified covered outpatient
drug for use in setting the payment
rates under subparagraph (A).
(iii) Survey requirements.--The
surveys conducted under clauses (i) and
(ii) shall have a large sample of
hospitals that is sufficient to
generate a statistically significant
estimate of the average hospital
acquisition cost for each specified
covered outpatient drug. With respect
to the surveys conducted under clause
(i), the Comptroller General shall
report to Congress on the justification
for the size of the sample used in
order to assure the validity of such
estimates.
(iv) Differentiation in cost.--In
conducting surveys under clause (i),
the Comptroller General shall determine
and report to Congress if there is (and
the extent of any) variation in
hospital acquisition costs for drugs
among hospitals based on the volume of
covered OPD services performed by such
hospitals or other relevant
characteristics of such hospitals (as
defined by the Comptroller General).
(v) Comment on proposed rates.--Not
later than 30 days after the date the
Secretary promulgated proposed rules
setting forth the payment rates under
subparagraph (A) for 2006, the
Comptroller General shall evaluate such
proposed rates and submit to Congress a
report regarding the appropriateness of
such rates based on the surveys the
Comptroller General has conducted under
clause (i).
(E) Adjustment in payment rates for overhead
costs.--
(i) Medpac report on drug apc
design.--The Medicare Payment Advisory
Commission shall submit to the
Secretary, not later than July 1, 2005,
a report on adjustment of payment for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account overhead and related
expenses, such as pharmacy services and
handling costs. Such report shall
include--
(I) a description and
analysis of the data available
with regard to such expenses;
(II) a recommendation as to
whether such a payment
adjustment should be made; and
(III) if such adjustment
should be made, a
recommendation regarding the
methodology for making such an
adjustment.
(ii) Adjustment authorized.--The
Secretary may adjust the weights for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account the recommendations
contained in the report submitted under
clause (i).
(F) Classes of drugs.--For purposes of this
paragraph:
(i) Sole source drugs.--The term
``sole source drug'' means--
(I) a biological product (as
defined under section
1861(t)(1)); or
(II) a single source drug (as
defined in section
1927(k)(7)(A)(iv)).
(ii) Innovator multiple source
drugs.--The term ``innovator multiple
source drug'' has the meaning given
such term in section 1927(k)(7)(A)(ii).
(iii) Noninnovator multiple source
drugs.--The term ``noninnovator
multiple source drug'' has the meaning
given such term in section
1927(k)(7)(A)(iii).
(G) Reference average wholesale price.--The
term ``reference average wholesale price''
means, with respect to a specified covered
outpatient drug, the average wholesale price
for the drug as determined under section
1842(o) as of May 1, 2003.
(H) Inapplicability of expenditures in
determining conversion, weighting, and other
adjustment factors.--Additional expenditures
resulting from this paragraph shall not be
taken into account in establishing the
conversion, weighting, and other adjustment
factors for 2004 and 2005 under paragraph (9),
but shall be taken into account for subsequent
years.
(15) Payment for new drugs and biologicals until
hcpcs code assigned.--With respect to payment under
this part for an outpatient drug or biological that is
covered under this part and is furnished as part of
covered OPD services for which a HCPCS code has not
been assigned, the amount provided for payment for such
drug or biological under this part shall be equal to 95
percent of the average wholesale price for the drug or
biological.
(16) Miscellaneous provisions.--
(A) Application of reclassification of
certain hospitals.--If a hospital is being
treated as being located in a rural area under
section 1886(d)(8)(E), that hospital shall be
treated under this subsection as being located
in that rural area.
(B) Threshold for establishment of separate
apcs for drugs.--The Secretary shall reduce the
threshold for the establishment of separate
ambulatory payment classification groups (APCs)
with respect to drugs or biologicals to $50 per
administration for drugs and biologicals
furnished in 2005 and 2006.
(C) Payment for devices of brachytherapy and
therapeutic radiopharmaceuticals at charges
adjusted to cost.--Notwithstanding the
preceding provisions of this subsection, for a
device of brachytherapy consisting of a seed or
seeds (or radioactive source) furnished on or
after January 1, 2004, and before January 1,
2010, and for therapeutic radiopharmaceuticals
furnished on or after January 1, 2008, and
before January 1, 2010, the payment basis for
the device or therapeutic radiopharmaceutical
under this subsection shall be equal to the
hospital's charges for each device or
therapeutic radiopharmaceutical furnished,
adjusted to cost. Charges for such devices or
therapeutic radiopharmaceuticals shall not be
included in determining any outlier payment
under this subsection.
(D) Special payment rule.--
(i) In general.--In the case of
covered OPD services furnished on or
after April 1, 2013, in a hospital
described in clause (ii), if--
(I) the payment rate that
would otherwise apply under
this subsection for
stereotactic radiosurgery,
complete course of treatment of
cranial lesion(s) consisting of
1 session that is multi-source
Cobalt 60 based (identified as
of January 1, 2013, by HCPCS
code 77371 (and any succeeding
code) and reimbursed as of such
date under APC 0127 (and any
succeeding classification
group)); exceeds
(II) the payment rate that
would otherwise apply under
this subsection for linear
accelerator based stereotactic
radiosurgery, complete course
of therapy in one session
(identified as of January 1,
2013, by HCPCS code G0173 (and
any succeeding code) and
reimbursed as of such date
under APC 0067 (and any
succeeding classification
group)),
the payment rate for the service
described in subclause (I) shall be
reduced to an amount equal to the
payment rate for the service described
in subclause (II).
(ii) Hospital described.--A hospital
described in this clause is a hospital
that is not--
(I) located in a rural area
(as defined in section
1886(d)(2)(D));
(II) classified as a rural
referral center under section
1886(d)(5)(C); or
(III) a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)).
(iii) Not budget neutral.--In making
any budget neutrality adjustments under
this subsection for 2013 (with respect
to covered OPD services furnished on or
after April 1, 2013, and before January
1, 2014) or a subsequent year, the
Secretary shall not take into account
the reduced expenditures that result
from the application of this
subparagraph.
(E) Application of appropriate use criteria
for certain imaging services.--For provisions
relating to the application of appropriate use
criteria for certain imaging services, see
section 1834(q).
(F) Payment incentive for the transition from
traditional x-ray imaging to digital
radiography.--Notwithstanding the previous
provisions of this subsection:
(i) Limitation on payment for film x-
ray imaging services.--In the case of
an imaging service that is an X-ray
taken using film and that is furnished
during 2017 or a subsequent year, the
payment amount for such service
(including the X-ray component of a
packaged service) that would otherwise
be determined under this section
(without application of this paragraph
and before application of any other
adjustment under this subsection) for
such year shall be reduced by 20
percent.
(ii) Phased-in limitation on payment
for computed radiography imaging
services.--In the case of an imaging
service that is an X-ray taken using
computed radiography technology (as
defined in section 1848(b)(9)(C))--
(I) in the case of such a
service furnished during 2018,
2019, 2020, 2021, or 2022, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 7 percent; and
(II) in the case of such a
service furnished during 2023
or a subsequent year, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 10 percent.
(iii) Application without regard to
budget neutrality.--The reductions made
under this subparagraph--
(I) shall not be considered
an adjustment under paragraph
(2)(E); and
(II) shall not be implemented
in a budget neutral manner.
(iv) Implementation.--In order to
implement this subparagraph, the
Secretary shall adopt appropriate
mechanisms which may include use of
modifiers.
(17) Quality reporting.--
(A) Reduction in update for failure to
report.--
(i) In general.--For purposes of
paragraph (3)(C)(iv) for 2009 and each
subsequent year, in the case of a
subsection (d) hospital (as defined in
section 1886(d)(1)(B)) that does not
submit, to the Secretary in accordance
with this paragraph, data required to
be submitted on measures selected under
this paragraph with respect to such a
year, the OPD fee schedule increase
factor under paragraph (3)(C)(iv) for
such year shall be reduced by 2.0
percentage points.
(ii) Non-cumulative application.--A
reduction under this subparagraph shall
apply only with respect to the year
involved and the Secretary shall not
take into account such reduction in
computing the OPD fee schedule increase
factor for a subsequent year.
(B) Form and manner of submission.--Each
subsection (d) hospital shall submit data on
measures selected under this paragraph to the
Secretary in a form and manner, and at a time,
specified by the Secretary for purposes of this
paragraph.
(C) Development of outpatient measures.--
(i) In general.--The Secretary shall
develop measures that the Secretary
determines to be appropriate for the
measurement of the quality of care
(including medication errors) furnished
by hospitals in outpatient settings and
that reflect consensus among affected
parties and, to the extent feasible and
practicable, shall include measures set
forth by one or more national consensus
building entities.
(ii) Construction.--Nothing in this
paragraph shall be construed as
preventing the Secretary from selecting
measures that are the same as (or a
subset of) the measures for which data
are required to be submitted under
section 1886(b)(3)(B)(viii).
(D) Replacement of measures.--For purposes of
this paragraph, the Secretary may replace any
measures or indicators in appropriate cases,
such as where all hospitals are effectively in
compliance or the measures or indicators have
been subsequently shown not to represent the
best clinical practice.
(E) Availability of data.--The Secretary
shall establish procedures for making data
submitted under this paragraph available to the
public. Such procedures shall ensure that a
hospital has the opportunity to review the data
that are to be made public with respect to the
hospital prior to such data being made public.
The Secretary shall report quality measures of
process, structure, outcome, patients'
perspectives on care, efficiency, and costs of
care that relate to services furnished in
outpatient settings in hospitals on the
Internet website of the Centers for Medicare &
Medicaid Services.
(18) Authorization of adjustment for cancer
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
described in section 1886(d)(1)(B)(v) with
respect to ambulatory payment classification
groups exceed those costs incurred by other
hospitals furnishing services under this
subsection (as determined appropriate by the
Secretary). In conducting the study under this
subparagraph, the Secretary shall take into
consideration the cost of drugs and biologicals
incurred by such hospitals.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals described in
section 1886(d)(1)(B)(v) exceed those costs
incurred by other hospitals furnishing services
under this subsection, the Secretary shall,
subject to subparagraph (C), provide for an
appropriate adjustment under paragraph (2)(E)
to reflect those higher costs effective for
services furnished on or after January 1, 2011.
(C) Target pcr adjustment.--In applying
section 419.43(i) of title 42 of the Code of
Federal Regulations to implement the
appropriate adjustment under this paragraph for
services furnished on or after January 1, 2018,
the Secretary shall use a target PCR that is
1.0 percentage points less than the target PCR
that would otherwise apply. In addition to the
percentage point reduction under the previous
sentence, the Secretary may consider making an
additional percentage point reduction to such
target PCR that takes into account payment
rates for applicable items and services
described in paragraph (21)(C) other than for
services furnished by hospitals described in
section 1886(d)(1)(B)(v). In making any budget
neutrality adjustments under this subsection
for 2018 or a subsequent year, the Secretary
shall not take into account the reduced
expenditures that result from the application
of this subparagraph.
(19) Floor on area wage adjustment factor for
hospital outpatient department services in frontier
states.--
(A) In general.--Subject to subparagraph (B),
with respect to covered OPD services furnished
on or after January 1, 2011, the area wage
adjustment factor applicable under the payment
system established under this subsection to any
hospital outpatient department which is located
in a frontier State (as defined in section
1886(d)(3)(E)(iii)(II)) may not be less than
1.00. The preceding sentence shall not be
applied in a budget neutral manner.
(B) Limitation.--This paragraph shall not
apply to any hospital outpatient department
located in a State that receives a non-labor
related share adjustment under section
1886(d)(5)(H).
(20) Not budget neutral application of reduced
expenditures resulting from quality incentives for
computed tomography.--The Secretary shall not take into
account the reduced expenditures that result from the
application of section 1834(p) in making any budget
neutrality adjustments this subsection.
(21) Services furnished by an off-campus outpatient
department of a provider.--
(A) Applicable items and services.--For
purposes of paragraph (1)(B)(v) and this
paragraph, the term ``applicable items and
services'' means items and services other than
items and services furnished by a dedicated
emergency department (as defined in section
489.24(b) of title 42 of the Code of Federal
Regulations).
(B) Off-campus outpatient department of a
provider.--
(i) In general.--For purposes of
paragraph (1)(B)(v) and this paragraph,
subject to the subsequent provisions of
this subparagraph, the term ``off-
campus outpatient department of a
provider'' means a department of a
provider (as defined in section
413.65(a)(2) of title 42 of the Code of
Federal Regulations, as in effect as of
the date of the enactment of this
paragraph) that is not located--
(I) on the campus (as defined
in such section 413.65(a)(2))
of such provider; or
(II) within the distance
(described in such definition
of campus) from a remote
location of a hospital facility
(as defined in such section
413.65(a)(2)).
(ii) Exception.--For purposes of
paragraph (1)(B)(v) and this paragraph,
the term ``off-campus outpatient
department of a provider'' shall not
include a department of a provider (as
so defined) that was billing under this
subsection with respect to covered OPD
services furnished prior to the date of
the enactment of this paragraph.
(iii) Deemed treatment for 2017.--For
purposes of applying clause (ii) with
respect to applicable items and
services furnished during 2017, a
department of a provider (as so
defined) not described in such clause
is deemed to be billing under this
subsection with respect to covered OPD
services furnished prior to November 2,
2015, if the Secretary received from
the provider prior to December 2, 2015,
an attestation (pursuant to section
413.65(b)(3) of title 42 of the Code of
Federal Regulations) that such
department was a department of a
provider (as so defined).
(iv) Alternative exception beginning
with 2018.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2018 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if--
(I) the Secretary receives
from the provider an
attestation (pursuant to such
section 413.65(b)(3)) not later
than December 31, 2016 (or, if
later, 60 days after the date
of the enactment of this
clause), that such department
met the requirements of a
department of a provider
specified in section 413.65 of
title 42 of the Code of Federal
Regulations;
(II) the provider includes
such department as part of the
provider on its enrollment form
in accordance with the
enrollment process under
section 1866(j); and
(III) the department met the
mid-build requirement of clause
(v) and the Secretary receives,
not later than 60 days after
the date of the enactment of
this clause, from the chief
executive officer or chief
operating officer of the
provider a written
certification that the
department met such
requirement.
(v) Mid-build requirement
described.--The mid-build requirement
of this clause is, with respect to a
department of a provider, that before
November 2, 2015, the provider had a
binding written agreement with an
outside unrelated party for the actual
construction of such department.
(vi) Exclusion for certain cancer
hospitals.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2017 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if the
provider is a hospital described in
section 1886(d)(1)(B)(v) and--
(I) in the case of a
department that met the
requirements of section 413.65
of title 42 of the Code of
Federal Regulations after
November 1, 2015, and before
the date of the enactment of
this clause, the Secretary
receives from the provider an
attestation that such
department met such
requirements not later than 60
days after such date of
enactment; or
(II) in the case of a
department that meets such
requirements after such date of
enactment, the Secretary
receives from the provider an
attestation that such
department meets such
requirements not later than 60
days after the date such
requirements are first met with
respect to such department.
(vii) Audit.--Not later than December
31, 2018, the Secretary shall audit the
compliance with requirements of clause
(iv) with respect to each department of
a provider to which such clause
applies. Not later than 2 years after
the date the Secretary receives an
attestation under clause (vi) relating
to compliance of a department of a
provider with requirements referred to
in such clause, the Secretary shall
audit the compliance with such
requirements with respect to the
department. If the Secretary finds as a
result of an audit under this clause
that the applicable requirements were
not met with respect to such
department, the department shall not be
excluded from the term ``off-campus
outpatient department of a provider''
under such clause.
(viii) Implementation.--For purposes
of implementing clauses (iii) through
(vii):
(I) Notwithstanding any other
provision of law, the Secretary
may implement such clauses by
program instruction or
otherwise.
(II) Subchapter I of chapter
35 of title 44, United States
Code, shall not apply.
(III) For purposes of
carrying out this subparagraph
with respect to clauses (iii)
and (iv) (and clause (vii)
insofar as it relates to clause
(iv)), $10,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
December 31, 2018. For purposes
of carrying out this
subparagraph with respect to
clause (vi) (and clause (vii)
insofar as it relates to such
clause), $2,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
expended.
(C) Availability of payment under other
payment systems.--Payments for applicable items
and services furnished by an off-campus
outpatient department of a provider that are
described in paragraph (1)(B)(v) shall be made
under the applicable payment system under this
part (other than under this subsection) if the
requirements for such payment are otherwise
met.
(D) Information needed for implementation.--
Each hospital shall provide to the Secretary
such information as the Secretary determines
appropriate to implement this paragraph and
paragraph (1)(B)(v) (which may include
reporting of information on a hospital claim
using a code or modifier and reporting
information about off-campus outpatient
departments of a provider on the enrollment
form described in section 1866(j)).
(E) Limitations.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the
following:
(i) The determination of the
applicable items and services under
subparagraph (A) and applicable payment
systems under subparagraph (C).
(ii) The determination of whether a
department of a provider meets the term
described in subparagraph (B).
(iii) Any information that hospitals
are required to report pursuant to
subparagraph (D).
(iv) The determination of an audit
under subparagraph (B)(vii).
(22) Review and revisions of payments for non-opioid
alternative treatments.--
(A) In general.--With respect to payments
made under this subsection for covered OPD
services (or groups of services), including
covered OPD services assigned to a
comprehensive ambulatory payment
classification, the Secretary--
(i) shall, as soon as practicable,
conduct a review (part of which may
include a request for information) of
payments for opioids and evidence-based
non-opioid alternatives for pain
management (including drugs and
devices, nerve blocks, surgical
injections, and neuromodulation) with a
goal of ensuring that there are not
financial incentives to use opioids
instead of non-opioid alternatives;
(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews
of such payments; and
(iii) shall consider the extent to
which revisions under this subsection
to such payments (such as the creation
of additional groups of covered OPD
services to classify separately those
procedures that utilize opioids and
non-opioid alternatives for pain
management) would reduce payment
incentives to use opioids instead of
non-opioid alternatives for pain
management.
(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering
revisions under clause (iii) of such
subparagraph, the Secretary shall focus on
covered OPD services (or groups of services)
assigned to a comprehensive ambulatory payment
classification, ambulatory payment
classifications that primarily include surgical
services, and other services determined by the
Secretary which generally involve treatment for
pain management.
(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph
(A)(iii), the Secretary shall, as determined
appropriate, begin making such revisions for
services furnished on or after January 1, 2020.
Revisions under the previous sentence shall be
treated as adjustments for purposes of
application of paragraph (9)(B).
(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the
Secretary--
(i) from conducting a demonstration
before making the revisions described
in subparagraph (C); or
(ii) prior to implementation of this
paragraph, from changing payments under
this subsection for covered OPD
services (or groups of services) which
include opioids or non-opioid
alternatives for pain management.
(u) Incentive Payments for Physician Scarcity Areas.--
(1) In general.--In the case of physicians' services
furnished on or after January 1, 2005, and before July
1, 2008--
(A) by a primary care physician in a primary
care scarcity county (identified under
paragraph (4)); or
(B) by a physician who is not a primary care
physician in a specialist care scarcity county
(as so identified),
in addition to the amount of payment that would
otherwise be made for such services under this part,
there also shall be paid an amount equal to 5 percent
of the payment amount for the service under this part.
(2) Determination of ratios of physicians to medicare
beneficiaries in area.--Based upon available data, the
Secretary shall establish for each county or equivalent
area in the United States, the following:
(A) Number of physicians practicing in the
area.--The number of physicians who furnish
physicians' services in the active practice of
medicine or osteopathy in that county or area,
other than physicians whose practice is
exclusively for the Federal Government,
physicians who are retired, or physicians who
only provide administrative services. Of such
number, the number of such physicians who are--
(i) primary care physicians; or
(ii) physicians who are not primary
care physicians.
(B) Number of medicare beneficiaries residing
in the area.--The number of individuals who are
residing in the county and are entitled to
benefits under part A or enrolled under this
part, or both (in this subsection referred to
as ``individuals'').
(C) Determination of ratios.--
(i) Primary care ratio.--The ratio
(in this paragraph referred to as the
``primary care ratio'') of the number
of primary care physicians (determined
under subparagraph (A)(i)), to the
number of individuals determined under
subparagraph (B).
(ii) Specialist care ratio.--The
ratio (in this paragraph referred to as
the ``specialist care ratio'') of the
number of other physicians (determined
under subparagraph (A)(ii)), to the
number of individuals determined under
subparagraph (B).
(3) Ranking of counties.--The Secretary shall rank
each such county or area based separately on its
primary care ratio and its specialist care ratio.
(4) Identification of counties.--
(A) In general.--The Secretary shall
identify--
(i) those counties and areas (in this
paragraph referred to as ``primary care
scarcity counties'') with the lowest
primary care ratios that represent, if
each such county or area were weighted
by the number of individuals determined
under paragraph (2)(B), an aggregate
total of 20 percent of the total of the
individuals determined under such
paragraph; and
(ii) those counties and areas (in
this subsection referred to as
``specialist care scarcity counties'')
with the lowest specialist care ratios
that represent, if each such county or
area were weighted by the number of
individuals determined under paragraph
(2)(B), an aggregate total of 20
percent of the total of the individuals
determined under such paragraph.
(B) Periodic revisions.--The Secretary shall
periodically revise the counties or areas
identified in subparagraph (A) (but not less
often than once every three years) unless the
Secretary determines that there is no new data
available on the number of physicians
practicing in the county or area or the number
of individuals residing in the county or area,
as identified in paragraph (2).
(C) Identification of counties where service
is furnished.--For purposes of paying the
additional amount specified in paragraph (1),
if the Secretary uses the 5-digit postal ZIP
Code where the service is furnished, the
dominant county of the postal ZIP Code (as
determined by the United States Postal Service,
or otherwise) shall be used to determine
whether the postal ZIP Code is in a scarcity
county identified in subparagraph (A) or
revised in subparagraph (B).
(D) Special rule.--With respect to
physicians' services furnished on or after
January 1, 2008, and before July 1, 2008, for
purposes of this subsection, the Secretary
shall use the primary care scarcity counties
and the specialty care scarcity counties (as
identified under the preceding provisions of
this paragraph) that the Secretary was using
under this subsection with respect to
physicians' services furnished on December 31,
2007.
(E) Judicial review.--There shall be no
administrative or judicial review under section
1869, 1878, or otherwise, respecting--
116.(i) the identification of a
county or area;
(ii) the assignment of a specialty of
any physician under this paragraph;
(iii) the assignment of a physician
to a county under paragraph (2); or
(iv) the assignment of a postal ZIP
Code to a county or other area under
this subsection.
(5) Rural census tracts.--To the extent feasible, the
Secretary shall treat a rural census tract of a
metropolitan statistical area (as determined under the
most recent modification of the Goldsmith Modification,
originally published in the Federal Register on
February 27, 1992 (57 Fed. Reg. 6725)), as an
equivalent area for purposes of qualifying as a primary
care scarcity county or specialist care scarcity county
under this subsection.
(6) Physician Defined.--For purposes of this
paragraph, the term ``physician'' means a physician
described in section 1861(r)(1) and the term ``primary
care physician'' means a physician who is identified in
the available data as a general practitioner, family
practice practitioner, general internist, or
obstetrician or gynecologist.
(7) Publication of list of counties; posting on
website.--With respect to a year for which a county or
area is identified or revised under paragraph (4), the
Secretary shall identify such counties or areas as part
of the proposed and final rule to implement the
physician fee schedule under section 1848 for the
applicable year. The Secretary shall post the list of
counties identified or revised under paragraph (4) on
the Internet website of the Centers for Medicare &
Medicaid Services.
(v) Increase of FQHC Payment Limits.--In the case of services
furnished by Federally qualified health centers (as defined in
section 1861(aa)(4)), the Secretary shall establish payment
limits with respect to such services under this part for
services furnished--
(1) in 2010, at the limits otherwise established
under this part for such year increased by $5; and
(2) in a subsequent year, at the limits established
under this subsection for the previous year increased
by the percentage increase in the MEI (as defined in
section 1842(i)(3)) for such subsequent year.
(w) Methods of Payment.--The Secretary may develop
alternative methods of payment for items and services provided
under clinical trials and comparative effectiveness studies
sponsored or supported by an agency of the Department of Health
and Human Services, as determined by the Secretary, to those
that would otherwise apply under this section, to the extent
such alternative methods are necessary to preserve the
scientific validity of such trials or studies, such as in the
case where masking the identity of interventions from patients
and investigators is necessary to comply with the particular
trial or study design.
(x) Incentive Payments for Primary Care Services.--
(1) In general.--In the case of primary care services
furnished on or after January 1, 2011, and before
January 1, 2016, by a primary care practitioner, in
addition to the amount of payment that would otherwise
be made for such services under this part, there also
shall be paid (on a monthly or quarterly basis) an
amount equal to 10 percent of the payment amount for
the service under this part.
(2) Definitions.--In this subsection:
(A) Primary care practitioner.--The term
``primary care practitioner'' means an
individual--
(i) who--
(I) is a physician (as
described in section
1861(r)(1)) who has a primary
specialty designation of family
medicine, internal medicine,
geriatric medicine, or
pediatric medicine; or
(II) is a nurse practitioner,
clinical nurse specialist, or
physician assistant (as those
terms are defined in section
1861(aa)(5)); and
(ii) for whom primary care services
accounted for at least 60 percent of
the allowed charges under this part for
such physician or practitioner in a
prior period as determined appropriate
by the Secretary.
(B) Primary care services.--The term
``primary care services'' means services
identified, as of January 1, 2009, by the
following HCPCS codes (and as subsequently
modified by the Secretary):
(i) 99201 through 99215.
(ii) 99304 through 99340.
(iii) 99341 through 99350.
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise, respecting the identification of
primary care practitioners under this subsection.
(y) Incentive Payments for Major Surgical Procedures
Furnished in Health Professional Shortage Areas.--
(1) In general.--In the case of major surgical
procedures furnished on or after January 1, 2011, and
before January 1, 2016, by a general surgeon 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 the year involved, in addition to the
amount of payment that would otherwise be made for such
services under this part, there also shall be paid (on
a monthly or quarterly basis) an amount equal to 10
percent of the payment amount for the service under
this part.
(2) Definitions.--In this subsection:
(A) General surgeon.--In this subsection, the
term ``general surgeon'' means a physician (as
described in section 1861(r)(1)) who has
designated CMS specialty code 02-General
Surgery as their primary specialty code in the
physician's enrollment under section 1866(j).
(B) Major surgical procedures.--The term
``major surgical procedures'' means physicians'
services which are surgical procedures for
which a 10-day or 90-day global period is used
for payment under the fee schedule under
section 1848(b).
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Application.--The provisions of paragraph (2) and
(4) of subsection (m) shall apply to the determination
of additional payments under this subsection in the
same manner as such provisions apply to the
determination of additional payments under subsection
(m).
(z) Incentive Payments for Participation in Eligible
Alternative Payment Models.--
(1) Payment incentive.--
(A) In general.--In the case of covered
professional services furnished by an eligible
professional during a year that is in the
period beginning with 2019 and ending with 2024
and for which the professional is a qualifying
APM participant with respect to such year, in
addition to the amount of payment that would
otherwise be made for such covered professional
services under this part for such year, there
also shall be paid to such professional an
amount equal to 5 percent of the estimated
aggregate payment amounts for such covered
professional services under this part for the
preceding year. For purposes of the previous
sentence, the payment amount for the preceding
year may be an estimation for the full
preceding year based on a period of such
preceding year that is less than the full year.
The Secretary shall establish policies to
implement this subparagraph in cases in which
payment for covered professional services
furnished by a qualifying APM participant in an
alternative payment model--
(i) is made to an eligible
alternative payment entity rather than
directly to the qualifying APM
participant; or
(ii) is made on a basis other than a
fee-for-service basis (such as payment
on a capitated basis).
(B) Form of payment.--Payments under this
subsection shall be made in a lump sum, on an
annual basis, as soon as practicable.
(C) Treatment of payment incentive.--Payments
under this subsection shall not be taken into
account for purposes of determining actual
expenditures under an alternative payment model
and for purposes of determining or rebasing any
benchmarks used under the alternative payment
model.
(D) Coordination.--The amount of the
additional payment under this subsection or
subsection (m) shall be determined without
regard to any additional payment under
subsection (m) and this subsection,
respectively. The amount of the additional
payment under this subsection or subsection (x)
shall be determined without regard to any
additional payment under subsection (x) and
this subsection, respectively. The amount of
the additional payment under this subsection or
subsection (y) shall be determined without
regard to any additional payment under
subsection (y) and this subsection,
respectively.
(2) Qualifying apm participant.--For purposes of this
subsection, the term ``qualifying APM participant''
means the following:
(A) 2019 and 2020.--With respect to 2019 and
2020, an eligible professional for whom the
Secretary determines that at least 25 percent
of payments under this part for covered
professional services furnished by such
professional during the most recent period for
which data are available (which may be less
than a year) were attributable to such services
furnished under this part through an eligible
alternative payment entity.
(B) 2021 through 2024.--With respect to each
of 2021 through 2024, an eligible professional
described in either of the following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 50 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 50 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(C) Beginning in 2025.--With respect to 2025
and each subsequent year, an eligible
professional described in either of the
following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 75 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 75 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(D) Use of patient approach.--The Secretary
may base the determination of whether an
eligible professional is a qualifying APM
participant under this subsection and the
determination of whether an eligible
professional is a partial qualifying APM
participant under section 1848(q)(1)(C)(iii) by
using counts of patients in lieu of using
payments and using the same or similar
percentage criteria (as specified in this
subsection and such section, respectively), as
the Secretary determines appropriate. With
respect to 2023 and 2024, the Secretary shall
use the same percentage criteria for counts of
patients that are used in 2022.
(3) Additional definitions.--In this subsection:
(A) Covered professional services.--The term
``covered professional services'' has the
meaning given that term in section
1848(k)(3)(A).
(B) Eligible professional.--The term
``eligible professional'' has the meaning given
that term in section 1848(k)(3)(B) and includes
a group that includes such professionals.
(C) Alternative payment model (apm).--The
term ``alternative payment model'' means, other
than for purposes of subparagraphs
(B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph
(2), any of the following:
(i) A model under section 1115A
(other than a health care innovation
award).
(ii) The shared savings program under
section 1899.
(iii) A demonstration under section
1866C.
(iv) A demonstration required by
Federal law.
(D) Eligible alternative payment entity.--The
term ``eligible alternative payment entity''
means, with respect to a year, an entity that--
(i) participates in an alternative
payment model that--
(I) requires participants in
such model to use certified EHR
technology (as defined in
subsection (o)(4)); and
(II) provides for payment for
covered professional services
based on quality measures
comparable to measures under
the performance category
described in section
1848(q)(2)(B)(i); and
(ii)(I) bears financial risk for
monetary losses under such alternative
payment model that are in excess of a
nominal amount; or
(II) is a medical home expanded under
section 1115A(c).
(4) Limitation.--There shall be no administrative or
judicial review under section 1869, 1878, or otherwise,
of the following:
(A) The determination that an eligible
professional is a qualifying APM participant
under paragraph (2) and the determination that
an entity is an eligible alternative payment
entity under paragraph (3)(D).
(B) The determination of the amount of the 5
percent payment incentive under paragraph
(1)(A), including any estimation as part of
such determination.
(aa) Medical Review of Spinal Subluxation Services.--
(1) In general.--The Secretary shall implement a
process for the medical review (as described in
paragraph (2)) of treatment by a chiropractor described
in section 1861(r)(5) by means of manual manipulation
of the spine to correct a subluxation (as described in
such section) of an individual who is enrolled under
this part and apply such process to such services
furnished on or after January 1, 2017, focusing on
services such as--
(A) services furnished by a such a
chiropractor whose pattern of billing is
aberrant compared to peers; and
(B) services furnished by such a chiropractor
who, in a prior period, has a services denial
percentage in the 85th percentile or greater,
taking into consideration the extent that
service denials are overturned on appeal.
(2) Medical review.--
(A) Prior authorization medical review.--
(i) In general.--Subject to clause
(ii), the Secretary shall use prior
authorization medical review for
services described in paragraph (1)
that are furnished to an individual by
a chiropractor described in section
1861(r)(5) that are part of an episode
of treatment that includes more than 12
services. For purposes of the preceding
sentence, an episode of treatment shall
be determined by the underlying cause
that justifies the need for services,
such as a diagnosis code.
(ii) Ending application of prior
authorization medical review.--The
Secretary shall end the application of
prior authorization medical review
under clause (i) to services described
in paragraph (1) by such a chiropractor
if the Secretary determines that the
chiropractor has a low denial rate
under such prior authorization medical
review. The Secretary may subsequently
reapply prior authorization medical
review to such chiropractor if the
Secretary determines it to be
appropriate and the chiropractor has,
in the time period subsequent to the
determination by the Secretary of a low
denial rate with respect to the
chiropractor, furnished such services
described in paragraph (1).
(iii) Early request for prior
authorization review permitted.--
Nothing in this subsection shall be
construed to prevent such a
chiropractor from requesting prior
authorization for services described in
paragraph (1) that are to be furnished
to an individual before the
chiropractor furnishes the twelfth such
service to such individual for an
episode of treatment.
(B) Type of review.--The Secretary may use
pre-payment review or post-payment review of
services described in section 1861(r)(5) that
are not subject to prior authorization medical
review under subparagraph (A).
(C) Relationship to law enforcement
activities.--The Secretary may determine that
medical review under this subsection does not
apply in the case where potential fraud may be
involved.
(3) No payment without prior authorization.--With
respect to a service described in paragraph (1) for
which prior authorization medical review under this
subsection applies, the following shall apply:
(A) Prior authorization determination.--The
Secretary shall make a determination, prior to
the service being furnished, of whether the
service would or would not meet the applicable
requirements of section 1862(a)(1)(A).
(B) Denial of payment.--Subject to paragraph
(5), no payment may be made under this part for
the service unless the Secretary determines
pursuant to subparagraph (A) that the service
would meet the applicable requirements of such
section 1862(a)(1)(A).
(4) Submission of information.--A chiropractor
described in section 1861(r)(5) may submit the
information necessary for medical review by fax, by
mail, or by electronic means. The Secretary shall make
available the electronic means described in the
preceding sentence as soon as practicable.
(5) Timeliness.--If the Secretary does not make a
prior authorization determination under paragraph
(3)(A) within 14 business days of the date of the
receipt of medical documentation needed to make such
determination, paragraph (3)(B) shall not apply.
(6) Application of limitation on beneficiary
liability.--Where payment may not be made as a result
of the application of paragraph (2)(B), section 1879
shall apply in the same manner as such section applies
to a denial that is made by reason of section
1862(a)(1).
(7) Review by contractors.--The medical review
described in paragraph (2) may be conducted by medicare
administrative contractors pursuant to section
1874A(a)(4)(G) or by any other contractor determined
appropriate by the Secretary that is not a recovery
audit contractor.
(8) Multiple services.--The Secretary shall, where
practicable, apply the medical review under this
subsection in a manner so as to allow an individual
described in paragraph (1) to obtain, at a single time
rather than on a service-by-service basis, an
authorization in accordance with paragraph (3)(A) for
multiple services.
(9) Construction.--With respect to a service
described in paragraph (1) that has been affirmed by
medical review under this subsection, nothing in this
subsection shall be construed to preclude the
subsequent denial of a claim for such service that does
not meet other applicable requirements under this Act.
(10) Implementation.--
(A) Authority.--The Secretary may implement
the provisions of this subsection by interim
final rule with comment period.
(B) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to medical
review under this subsection.
(bb) Additional Payments for Certain Rural Health Clinics
With Physicians or Practitioners Receiving DATA 2000 Waivers.--
(1) In general.--In the case of a rural health clinic
with respect to which, beginning on or after January 1,
2019, rural health clinic services (as defined in
section 1861(aa)(1)) are furnished for the treatment of
opioid use disorder by a physician or practitioner who
meets the requirements described in paragraph (3), the
Secretary shall, subject to availability of funds under
paragraph (4), make a payment (at such time and in such
manner as specified by the Secretary) to such rural
health clinic after receiving and approving an
application described in paragraph (2). Such payment
shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training
for purposes of receiving a waiver described in
paragraph (3)(B). Such payment may be made only one
time with respect to each such physician or
practitioner.
(2) Application.--In order to receive a payment
described in paragraph (1), a rural health clinic shall
submit to the Secretary an application for such a
payment at such time, in such manner, and containing
such information as specified by the Secretary. A rural
health clinic may apply for such a payment for each
physician or practitioner described in paragraph (1)
furnishing services described in such paragraph at such
clinic.
(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect
to a physician or practitioner, are the following:
(A) The physician or practitioner is employed
by or working under contract with a rural
health clinic described in paragraph (1) that
submits an application under paragraph (2).
(B) The physician or practitioner [first
receives a waiver under section 303(g) of the
Controlled Substances Act on or after January
1, 2019] first begins prescribing narcotic
drugs in schedule III, IV, or V of section 202
of the Controlled Substances Act for the
purpose of maintenance or detoxification
treatment on or after January 1, 2021.
(4) Funding.--For purposes of making payments under
this subsection, there are appropriated, out of amounts
in the Treasury not otherwise appropriated, $2,000,000,
which shall remain available until expended.
(cc) Specified COVID-19 Testing-Related Services.--For
purposes of subsection (a)(1)(DD):
(1) Description.--
(A) In general.--A specified COVID-19
testing-related service described in this
paragraph is a medical visit that--
(i) is in any of the categories of
HCPCS evaluation and management service
codes described in subparagraph (B);
(ii) is furnished during any portion
of the emergency period (as defined in
section 1135(g)(1)(B)) (beginning on or
after the date of enactment of this
subsection);
(iii) results in an order for or
administration of a clinical diagnostic
laboratory test described in section
1852(a)(1)(B)(iv)(IV); and
(iv) relates to the furnishing or
administration of such test or to the
evaluation of such individual for
purposes of determining the need of
such individual for such test.
(B) Categories of hcpcs codes.--For purposes
of subparagraph (A), the categories of HCPCS
evaluation and management services codes are
the following:
(i) Office and other outpatient
services.
(ii) Hospital observation services.
(iii) Emergency department services.
(iv) Nursing facility services.
(v) Domiciliary, rest home, or
custodial care services.
(vi) Home services.
(vii) Online digital evaluation and
management services.
(2) Specified outpatient payment provision.--A
specified outpatient payment provision described in
this paragraph is any of the following:
(A) The hospital outpatient prospective
payment system under subsection (t).
(B) The physician fee schedule under section
1848.
(C) The prospective payment system developed
under section 1834(o).
(D) Section 1834(g), with respect to an
outpatient critical access hospital service.
(E) The payment basis determined in
regulations pursuant to section 1833(a)(3) for
rural health clinic services.
(dd) Special Coinsurance Rule for Certain Colorectal Cancer
Screening Tests.--
(1) In general.--In the case of a colorectal cancer
screening test to which paragraph (1)(Y) of subsection
(a) would not apply but for the third sentence of such
subsection that is furnished during a year beginning on
or after January 1, 2022, and before January 1, 2030,
the amount paid shall be equal to the specified percent
(as defined in paragraph (2)) for such year of the
lesser of the actual charge for the service or the
amount determined under the fee schedule that applies
to such test under this part (or, in the case such test
is a covered OPD service (as defined in subsection
(t)(1)(B)), the amount determined under subsection
(t)).
(2) Specified percent defined.--For purposes of
paragraph (1), the term ``specified percent'' means--
(A) for 2022, 80 percent;
(B) for 2023 through 2026, 85 percent; and
(C) for 2027 through 2029, 90 percent.
SPECIAL PAYMENT RULES FOR PARTICULAR ITEMS AND SERVICES
Sec. 1834. (a) Payment for Durable Medical Equipment.--
(1) General rule for payment.--
(A) In general.--With respect to a covered
item (as defined in paragraph (13)) for which
payment is determined under this subsection,
payment shall be made in the frequency
specified in paragraphs (2) through (7) and in
an amount equal to 80 percent of the payment
basis described in subparagraph (B).
(B) Payment basis.--Subject to subparagraph
(F)(i), the payment basis described in this
subparagraph is the lesser of--
(i) the actual charge for the item,
or
(ii) the payment amount recognized
under paragraphs (2) through (7) of
this subsection for the item;
except that clause (i) shall not apply if the
covered item is furnished by a public home
health agency (or by another home health agency
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(C) Exclusive payment rule.--Subject to
subparagraph (F)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for covered items under this
part or under part A to a home health agency.
(D) Reduction in fee schedules for certain
items.--With respect to a seat-lift chair or
transcutaneous electrical nerve stimulator
furnished on or after April 1, 1990, the
Secretary shall reduce the payment amount
applied under subparagraph (B)(ii) for such an
item by 15 percent, and, in the case of a
transcutaneous electrical nerve stimulator
furnished on or after January 1, 1991, the
Secretary shall further reduce such payment
amount (as previously reduced) by 45 percent.
(E) Clinical conditions for coverage.--
(i) In general.--The Secretary shall
establish standards for clinical
conditions for payment for covered
items under this subsection.
(ii) Requirements.--The standards
established under clause (i) shall
include the specification of types or
classes of covered items that require,
as a condition of payment under this
subsection, a face-to-face examination
of the individual by a physician (as
defined in section 1861(r)), a
physician assistant, nurse
practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) and a
prescription for the item.
(iii) Priority of establishment of
standards.--In establishing the
standards under this subparagraph, the
Secretary shall first establish
standards for those covered items for
which the Secretary determines there
has been a proliferation of use,
consistent findings of charges for
covered items that are not delivered,
or consistent findings of falsification
of documentation to provide for payment
of such covered items under this part.
(iv) Standards for power
wheelchairs.--Effective on the date of
the enactment of this subparagraph, in
the case of a covered item consisting
of a motorized or power wheelchair for
an individual, payment may not be made
for such covered item unless a
physician (as defined in section
1861(r)(1)), a physician assistant,
nurse practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) has conducted a
face-to-face examination of the
individual and written a prescription
for the item.
(v) Limitation on payment for covered
items.--Payment may not be made for a
covered item under this subsection
unless the item meets any standards
established under this subparagraph for
clinical condition of coverage.
(F) Application of competitive acquisition;
limitation of inherent reasonableness
authority.--In the case of covered items
furnished on or after January 1, 2011, subject
to subparagraphs (G) and (H), that are included
in a competitive acquisition program in a
competitive acquisition area under section
1847(a)--
(i) the payment basis under this
subsection for such items and services
furnished in such area shall be the
payment basis determined under such
competitive acquisition program;
(ii) the Secretary may (and, in the
case of covered items furnished on or
after January 1, 2016, subject to
clause (iii), shall) use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847 and
in the case of such adjustment,
paragraph (10)(B) shall not be applied;
and
(iii) in the case of covered items
furnished on or after January 1, 2016,
the Secretary shall continue to make
such adjustments described in clause
(ii) as, under such competitive
acquisition programs, additional
covered items are phased in or
information is updated as contracts
under section 1847 are recompeted in
accordance with section 1847(b)(3)(B).
(G) Use of information on competitive bid
rates.--The Secretary shall specify by
regulation the methodology to be used in
applying the provisions of subparagraph (F)(ii)
and subsection (h)(1)(H)(ii). In promulgating
such regulation, the Secretary shall consider
the costs of items and services in areas in
which such provisions would be applied compared
to the payment rates for such items and
services in competitive acquisition areas.In
the case of items and services furnished on or
after January 1, 2019, in making any
adjustments under clause (ii) or (iii) of
subparagraph (F), under subsection
(h)(1)(H)(ii), or under section 1842(s)(3)(B),
the Secretary shall--
(i) solicit and take into account
stakeholder input; and
(ii) take into account the highest
amount bid by a winning supplier in a
competitive acquisition area and a
comparison of each of the following
with respect to non-competitive
acquisition areas and competitive
acquisition areas:
(I) The average travel
distance and cost associated
with furnishing items and
services in the area.
(II) The average volume of
items and services furnished by
suppliers in the area.
(III) The number of suppliers
in the area.
(H) Diabetic supplies.--
(i) In general.--On or after the date
described in clause (ii), the payment
amount under this part for diabetic
supplies, including testing strips,
that are non-mail order items (as
defined by the Secretary) shall be
equal to the single payment amounts
established under the national mail
order competition for diabetic supplies
under section 1847.
(ii) Date described.--The date
described in this clause is the date of
the implementation of the single
payment amounts under the national mail
order competition for diabetic supplies
under section 1847.
(I) Treatment of vacuum erection systems.--
Effective for items and services furnished on
and after July 1, 2015, vacuum erection systems
described as prosthetic devices described in
section 1861(s)(8) shall be treated in the same
manner as erectile dysfunction drugs are
treated for purposes of section 1860D-
2(e)(2)(A).
(2) Payment for inexpensive and other routinely
purchased durable medical equipment.--
(A) In general.--Payment for an item of
durable medical equipment (as defined in
paragraph (13))--
(i) the purchase price of which does
not exceed $150,
(ii) which the Secretary determines
is acquired at least 75 percent of the
time by purchase,
(iii) which is an accessory used in
conjunction with a nebulizer,
aspirator, or a ventilator excluded
under paragraph (3)(A), or
(iv) in the case of devices furnished
on or after October 1, 2015, which
serves as a speech generating device or
which is an accessory that is needed
for the individual to effectively
utilize such a device,
shall be made on a rental basis or in a lump-
sum amount for the purchase of the item. The
payment amount recognized for purchase or
rental of such equipment is the amount
specified in subparagraph (B) for purchase or
rental, except that the total amount of
payments with respect to an item may not exceed
the payment amount specified in subparagraph
(B) with respect to the purchase of the item.
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to the purchase or
rental of an item furnished in a carrier
service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the purchase or rental,
respectively, of the item for the 12-
month period ending on June 30, 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year
(reduced by 10 percent, in the case of
a blood glucose testing strip furnished
after 1997 for an individual with
diabetes).
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(3) Payment for items requiring frequent and
substantial servicing.--
(A) In general.--Payment for a covered item
(such as IPPB machines and ventilators,
excluding ventilators that are either
continuous airway pressure devices or
intermittent assist devices with continuous
airway pressure devices) for which there must
be frequent and substantial servicing in order
to avoid risk to the patient's health shall be
made on a monthly basis for the rental of the
item and the amount recognized is the amount
specified in subparagraph (B).
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to an item or device
furnished in a carrier service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the rental of the item or device
for the 12-month period ending with
June 1987, increased by the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 6-month period ending
with December 1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(4) Payment for certain customized items.--Payment
with respect to a covered item that is uniquely
constructed or substantially modified to meet the
specific needs of an individual patient, and for that
reason cannot be grouped with similar items for
purposes of payment under this title, shall be made in
a lump-sum amount (A) for the purchase of the item in a
payment amount based upon the carrier's individual
consideration for that item, and (B) for the reasonable
and necessary maintenance and servicing for parts and
labor not covered by the supplier's or manufacturer's
warranty, when necessary during the period of medical
need, and the amount recognized for such maintenance
and servicing shall be paid on a lump-sum, as needed
basis based upon the carrier's individual consideration
for that item. In the case of a wheelchair furnished on
or after January 1, 1992, the wheelchair shall be
treated as a customized item for purposes of this
paragraph if the wheelchair has been measured, fitted,
or adapted in consideration of the patient's body size,
disability, period of need, or intended use, and has
been assembled by a supplier or ordered from a
manufacturer who makes available customized features,
modifications, or components for wheelchairs that are
intended for an individual patient's use in accordance
with instructions from the patient's physician.
(5) Payment for oxygen and oxygen equipment.--
(A) In general.--Payment for oxygen and
oxygen equipment shall be made on a monthly
basis in the monthly payment amount recognized
under paragraph (9) for oxygen and oxygen
equipment (other than portable oxygen
equipment), subject to subparagraphs (B), (C),
(E), and (F).
(B) Add-on for portable oxygen equipment.--
When portable oxygen equipment is used, but
subject to subparagraph (D), the payment amount
recognized under subparagraph (A) shall be
increased by the monthly payment amount
recognized under paragraph (9) for portable
oxygen equipment.
(C) Volume adjustment.--When the attending
physician prescribes an oxygen flow rate--
(i) exceeding 4 liters per minute,
the payment amount recognized under
subparagraph (A), subject to
subparagraph (D), shall be increased by
50 percent, or
(ii) of less than 1 liter per minute,
the payment amount recognized under
subparagraph (A) shall be decreased by
50 percent.
(D) Limit on adjustment.--When portable
oxygen equipment is used and the attending
physician prescribes an oxygen flow rate
exceeding 4 liters per minute, there shall only
be an increase under either subparagraph (B) or
(C), whichever increase is larger, and not
under both such subparagraphs.
(E) Recertification for patients receiving
home oxygen therapy.--In the case of a patient
receiving home oxygen therapy services who, at
the time such services are initiated, has an
initial arterial blood gas value at or above a
partial pressure of 56 or an arterial oxygen
saturation at or above 89 percent (or such
other values, pressures, or criteria as the
Secretary may specify) no payment may be made
under this part for such services after the
expiration of the 90-day period that begins on
the date the patient first receives such
services unless the patient's attending
physician certifies that, on the basis of a
follow-up test of the patient's arterial blood
gas value or arterial oxygen saturation
conducted during the final 30 days of such 90-
day period, there is a medical need for the
patient to continue to receive such services.
(F) Rental Cap.--
(i) In general.--Payment for oxygen
equipment (including portable oxygen
equipment) under this paragraph may not
extend over a period of continuous use
(as determined by the Secretary) of
longer than 36 months.
(ii) Payments and rules after rental
cap.--After the 36th continuous month
during which payment is made for the
equipment under this paragraph--
(I) the supplier furnishing
such equipment under this
subsection shall continue to
furnish the equipment during
any period of medical need for
the remainder of the reasonable
useful lifetime of the
equipment, as determined by the
Secretary;
(II) payments for oxygen
shall continue to be made in
the amount recognized for
oxygen under paragraph (9) for
the period of medical need; and
(III) maintenance and
servicing payments shall, if
the Secretary determines such
payments are reasonable and
necessary, be made (for parts
and labor not covered by the
supplier's or manufacturer's
warranty, as determined by the
Secretary to be appropriate for
the equipment), and such
payments shall be in an amount
determined to be appropriate by
the Secretary.
(6) Payment for other covered items (other than
durable medical equipment).--Payment for other covered
items (other than durable medical equipment and other
covered items described in paragraph (3), (4), or (5))
shall be made in a lump-sum amount for the purchase of
the item in the amount of the purchase price recognized
under paragraph (8).
(7) Payment for other items of durable medical
equipment.--
(A) Payment.--In the case of an item of
durable medical equipment not described in
paragraphs (2) through (6), the following rules
shall apply:
(i) Rental.--
(I) In general.--Except as
provided in clause (iii),
payment for the item shall be
made on a monthly basis for the
rental of the item during the
period of medical need (but
payments under this clause may
not extend over a period of
continuous use (as determined
by the Secretary) of longer
than 13 months).
(II) Payment amount.--Subject
to subclause (III) and
subparagraph (B), the amount
recognized for the item, for
each of the first 3 months of
such period, is 10 percent of
the purchase price recognized
under paragraph (8) with
respect to the item, and, for
each of the remaining months of
such period, is 7.5 percent of
such purchase price.
(III) Special rule for power-
driven wheelchairs.--For
purposes of payment for power-
driven wheelchairs, subclause
(II) shall be applied by
substituting ``15 percent'' and
``6 percent'' for ``10
percent'' and ``7.5 percent'',
respectively.
(ii) Ownership after rental.--On the
first day that begins after the 13th
continuous month during which payment
is made for the rental of an item under
clause (i), the supplier of the item
shall transfer title to the item to the
individual.
(iii) Purchase agreement option for
complex, rehabilitative power-driven
wheelchairs.--In the case of a complex,
rehabilitative power-driven wheelchair,
at the time the supplier furnishes the
item, the supplier shall offer the
individual the option to purchase the
item, and payment for such item shall
be made on a lump-sum basis if the
individual exercises such option.
(iv) Maintenance and servicing.--
After the supplier transfers title to
the item under clause (ii) or in the
case of a power-driven wheelchair for
which a purchase agreement has been
entered into under clause (iii),
maintenance and servicing payments
shall, if the Secretary determines such
payments are reasonable and necessary,
be made (for parts and labor not
covered by the supplier's or
manufacturer's warranty, as determined
by the Secretary to be appropriate for
the particular type of durable medical
equipment), and such payments shall be
in an amount determined to be
appropriate by the Secretary.
(B) Range for rental amounts.--
(i) For 1989.--For items furnished
during 1989, the payment amount
recognized under subparagraph (A)(i)
shall not be more than 115 percent, and
shall not be less than 85 percent, of
the prevailing charge established for
rental of the item in January 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987.
(ii) For 1990.--For items furnished
during 1990, clause (i) shall apply in
the same manner as it applies to items
furnished during 1989.
(C) Replacement of items.--
(i) Establishment of reasonable
useful lifetime.--In accordance with
clause (iii), the Secretary shall
determine and establish a reasonable
useful lifetime for items of durable
medical equipment for which payment may
be made under this paragraph.
(ii) Payment for replacement items.--
If the reasonable lifetime of such an
item, as so established, has been
reached during a continuous period of
medical need, or the carrier determines
that the item is lost or irreparably
damaged, the patient may elect to have
payment for an item serving as a
replacement for such item made--
(I) on a monthly basis for
the rental of the replacement
item in accordance with
subparagraph (A); or
(II) in the case of an item
for which a purchase agreement
has been entered into under
subparagraph (A)(iii), in a
lump-sum amount for the
purchase of the item.
(iii) Length of reasonable useful
lifetime.--The reasonable useful
lifetime of an item of durable medical
equipment under this subparagraph shall
be equal to 5 years, except that, if
the Secretary determines that, on the
basis of prior experience in making
payments for such an item under this
title, a reasonable useful lifetime of
5 years is not appropriate with respect
to a particular item, the Secretary
shall establish an alternative
reasonable lifetime for such item.
(8) Purchase price recognized for miscellaneous
devices and items.--For purposes of paragraphs (6) and
(7), the amount that is recognized under this paragraph
as the purchase price for a covered item is the amount
described in subparagraph (C) of this paragraph,
determined as follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price, for each item
described--
(I) in paragraph (6) equal to
the average reasonable charge
in the locality for the
purchase of the item for the
12-month period ending with
June 1987, or
(II) in paragraph (7) equal
to the average of the purchase
prices on the claims submitted
on an assignment-related basis
for the unused item supplied
during the 6-month period
ending with December 1986.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(U.S. city average) for the 6-
month period ending with
December 1987,
(II) in 1991, equal to the
local purchase price computed
under this clause for the
previous year, increased by the
covered item update for 1991,
and decreased by the percentage
by which the average of the
reasonable charges for claims
paid for all items described in
paragraph (7) is lower than the
average of the purchase prices
submitted for such items during
the final 9 months of 1988; or
(III) in 1992, 1993, and 1994
equal to the local purchase
price computed under this
clause for the previous year
increased by the covered item
update for the year.
(B) Computation of national limited purchase
price.--With respect to the furnishing of a
particular item in a year, the Secretary shall
compute a national limited purchase price--
(i) for 1991, equal to the local
purchase price computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited purchase price may not exceed
100 percent of the weighted average of
all local purchase prices for the item
computed under such subparagraph for
the year, and may not be less than 85
percent of the weighted average of all
local purchase prices for the item
computed under such subparagraph for
the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local purchase
price computed under subparagraph
(A)(ii) for the item for the year,
except that such national limited
purchase price may not exceed 100
percent of the median of all local
purchase prices computed for the item
under such subparagraph for the year
and may not be less than 85 percent of
the median of all local purchase prices
computed under such subparagraph for
the item for the year; and
(iv) for each subsequent year, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year.
(C) Purchase price recognized.--For purposes
of paragraphs (6) and (7), the amount that is
recognized under this paragraph as the purchase
price for each item furnished--
(i) in 1989 or 1990, is 100 percent
of the local purchase price computed
under subparagraph (A)(ii)(I);
(ii) in 1991, is the sum of (I) 67
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1991, and (II) 33 percent of the
national limited purchase price
computed under subparagraph (B) for
1991;
(iii) in 1992, is the sum of (I) 33
percent of the local purchase price
computed under subparagraph
(A)(ii)(III) for 1992, and (II) 67
percent of the national limited
purchase price computed under
subparagraph (B) for 1992; and
(iv) in 1993 or a subsequent year, is
the national limited purchase price
computed under subparagraph (B) for
that year.
(9) Monthly payment amount recognized with respect to
oxygen and oxygen equipment.--For purposes of paragraph
(5), the amount that is recognized under this paragraph
for payment for oxygen and oxygen equipment is the
monthly payment amount described in subparagraph (C) of
this paragraph. Such amount shall be computed
separately (i) for all items of oxygen and oxygen
equipment (other than portable oxygen equipment) and
(ii) for portable oxygen equipment (each such group
referred to in this paragraph as an ``item'').
(A) Computation of local monthly payment
rate.--Each carrier under this section shall
compute a base local payment rate for each item
as follows:
(i) The carrier shall compute a base
local average monthly payment rate per
beneficiary as an amount equal to (I)
the total reasonable charges for the
item during the 12-month period ending
with December 1986, divided by (II) the
total number of months for all
beneficiaries receiving the item in the
area during the 12-month period for
which the carrier made payment for the
item under this title.
(ii) The carrier shall compute a
local average monthly payment rate for
the item applicable--
(I) to 1989 and 1990, equal
to 95 percent of the base local
average monthly payment rate
computed under clause (i) for
the item increased by the
percentage increase in the
consumer price index for all
urban consumers (U.S. city
average) for the 6-month period
ending with December 1987, or
(II) to 1991, 1992, 1993, and
1994 equal to the local average
monthly payment rate computed
under this clause for the item
for the previous year increased
by the covered item increase
for the year.
(B) Computation of national limited monthly
payment rate.--With respect to the furnishing
of an item in a year, the Secretary shall
compute a national limited monthly payment rate
equal to--
(i) for 1991, the local monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year, and may not
be less than 85 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local monthly
payment rate computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the median of all
local monthly payment rates computed
for the item under such subparagraph
for the year and may not be less than
85 percent of the median of all local
monthly payment rates computed for the
item under such subparagraph for the
year;
(iv) for 1995, 1996, and 1997, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year;
(v) for 1998, 75 percent of the
amount determined under this
subparagraph for 1997; and
(vi) for 1999 and each subsequent
year, 70 percent of the amount
determined under this subparagraph for
1997.
(C) Monthly payment amount recognized.--For
purposes of paragraph (5), the amount that is
recognized under this paragraph as the base
monthly payment amount for each item
furnished--
(i) in 1989 and in 1990, is 100
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii) for the item;
(ii) in 1991, is the sum of (I) 67
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1991, and (II) 33 percent of the
national limited monthly payment rate
computed under subparagraph (B)(i) for
the item for 1991;
(iii) in 1992, is the sum of (I) 33
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1992, and (II) 67 percent of the
national limited monthly payment rate
computed under subparagraph (B)(ii) for
the item for 1992; and
(iv) in a subsequent year, is the
national limited monthly payment rate
computed under subparagraph (B) for the
item for that year.
(D) Authority to create classes.--
(i) In general.--Subject to clause
(ii), the Secretary may establish
separate classes for any item of oxygen
and oxygen equipment and separate
national limited monthly payment rates
for each of such classes.
(ii) Budget neutrality.--The
Secretary may take actions under clause
(i) only to the extent such actions do
not result in expenditures for any year
to be more or less than the
expenditures which would have been made
if such actions had not been taken. The
requirement of the preceding sentence
shall not apply beginning with the
second calendar quarter beginning on or
after the date of the enactment of this
sentence.
(10) Exceptions and adjustments.--
(A) Areas outside continental united
states.--Exceptions to the amounts recognized
under the previous provisions of this
subsection shall be made to take into account
the unique circumstances of covered items
furnished in Alaska, Hawaii, or Puerto Rico.
(B) Adjustment for inherent reasonableness.--
The Secretary is authorized to apply the
provisions of paragraphs (8) and (9) of section
1842(b) to covered items and suppliers of such
items and payments under this subsection in an
area and with respect to covered items and
services for which the Secretary does not make
a payment amount adjustment under paragraph
(1)(F).
(C) Transcutaneous electrical nerve
stimulator (tens).--In order to permit an
attending physician time to determine whether
the purchase of a transcutaneous electrical
nerve stimulator is medically appropriate for a
particular patient, the Secretary may determine
an appropriate payment amount for the initial
rental of such item for a period of not more
than 2 months. If such item is subsequently
purchased, the payment amount with respect to
such purchase is the payment amount determined
under paragraph (2).
(11) Improper billing and requirement of physician
order.--
(A) Improper billing for certain rental
items.--Notwithstanding any other provision of
this title, a supplier of a covered item for
which payment is made under this subsection and
which is furnished on a rental basis shall
continue to supply the item without charge
(other than a charge provided under this
subsection for the maintenance and servicing of
the item) after rental payments may no longer
be made under this subsection. If a supplier
knowingly and willfully violates the previous
sentence, the Secretary may apply sanctions
against the supplier under section 1842(j)(2)
in the same manner such sanctions may apply
with respect to a physician.
(B) Requirement of physician order.--
(i) In general.--The Secretary is
authorized to require, for specified
covered items, that payment may be made
under this subsection with respect to
the item only if a physician enrolled
under section 1866(j) or an eligible
professional under section
1848(k)(3)(B) that is enrolled under
section 1866(j) has communicated to the
supplier, before delivery of the item,
a written order for the item.
(ii) Requirement for face to face
encounter.--The Secretary shall require
that such an order be written pursuant
to a physician, a physician assistant,
a nurse practitioner, or a clinical
nurse specialist (as those terms are
defined in section 1861(aa)(5))
documenting such physician, physician
assistant, practitioner, or specialist
has had a face-to-face encounter
(including through use of telehealth
under subsection (m) and other than
with respect to encounters that are
incident to services involved) with the
individual involved during the 6-month
period preceding such written order, or
other reasonable timeframe as
determined by the Secretary.
(12) Regional carriers.--The Secretary may designate,
by regulation under section 1842, one carrier for one
or more entire regions to process all claims within the
region for covered items under this section.
(13) Covered item.--In this subsection, the term
``covered item'' means durable medical equipment (as
defined in section 1861(n)), including such equipment
described in section 1861(m)(5), but not including
implantable items for which payment may be made under
section 1833(t).
(14) Covered item update.--In this subsection, the
term ``covered item update'' means, with respect to a
year--
(A) for 1991 and 1992, the percentage
increase in the consumer price index for all
urban consumers (U.S. city average) for the 12-
month period ending with June of the previous
year reduced by 1 percentage point;
(B) for 1993, 1994, 1995, 1996, and 1997, the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year;
(C) for each of the years 1998 through 2000,
0 percentage points;
(D) for 2001, the percentage increase in the
consumer price index for all urban consumers
(U.S. city average) for the 12-month period
ending with June 2000;
(E) for 2002, 0 percentage points;
(F) for 2003, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of 2002;
(G) for 2004 through 2006--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) for the year involved;
and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(H) for 2007--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage change determined by the
Secretary to be appropriate taking into
account recommendations contained in
the report of the Comptroller General
of the United States under section
302(c)(1)(B) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003; and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(I) for 2008--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) (as applied to the
payment amount for 2007 determined
after the application of the percentage
change under subparagraph (H)(i)); and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(J) for 2009--
(i) in the case of items and services
furnished in any geographic area, if
such items or services were selected
for competitive acquisition in any area
under the competitive acquisition
program under section
1847(a)(1)(B)(i)(I) before July 1,
2008, including related accessories but
only if furnished with such items and
services selected for such competition
and diabetic supplies but only if
furnished through mail order, - 9.5
percent; or
(ii) in the case of other items and
services, the percentage increase in
the consumer price index for all urban
consumers (U.S. urban average) for the
12-month period ending with June 2008;
(K) for 2010, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of the previous year; and
(L) for 2011 and each subsequent year--
(i) the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year, reduced by--
(ii) the productivity adjustment
described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (L)(ii) may result in
the covered item update under this paragraph being less
than 0.0 for a year, and may result in payment rates
under this subsection for a year being less than such
payment rates for the preceding year.
(15) Advance determinations of coverage for certain
items.--
(A) Development of lists of items by
secretary.--The Secretary may develop and
periodically update a list of items for which
payment may be made under this subsection that
the Secretary determines, on the basis of prior
payment experience, are frequently subject to
unnecessary utilization throughout a carrier's
entire service area or a portion of such area.
(B) Development of lists of suppliers by
secretary.--The Secretary may develop and
periodically update a list of suppliers of
items for which payment may be made under this
subsection with respect to whom--
(i) the Secretary has found that a
substantial number of claims for
payment under this part for items
furnished by the supplier have been
denied on the basis of the application
of section 1862(a)(1); or
(ii) the Secretary has identified a
pattern of overutilization resulting
from the business practice of the
supplier.
(C) Determinations of coverage in advance.--A
carrier shall determine in advance of delivery
of an item whether payment for the item may not
be made because the item is not covered or
because of the application of section
1862(a)(1) if--
(i) the item is included on the list
developed by the Secretary under
subparagraph (A);
(ii) the item is furnished by a
supplier included on the list developed
by the Secretary under subparagraph
(B); or
(iii) the item is a customized item
(other than inexpensive items specified
by the Secretary) and the patient to
whom the item is to be furnished or the
supplier requests that such advance
determination be made.
(16) Disclosure of information and surety bond.--The
Secretary shall not provide for the issuance (or
renewal) of a provider number for a supplier of durable
medical equipment, for purposes of payment under this
part for durable medical equipment furnished by the
supplier, unless the supplier provides the Secretary on
a continuing basis--
(A) with--
(i) full and complete information as
to the identity of each person with an
ownership or control interest (as
defined in section 1124(a)(3)) in the
supplier or in any subcontractor (as
defined by the Secretary in
regulations) in which the supplier
directly or indirectly has a 5 percent
or more ownership interest; and
(ii) to the extent determined to be
feasible under regulations of the
Secretary, the name of any disclosing
entity (as defined in section
1124(a)(2)) with respect to which a
person with such an ownership or
control interest in the supplier is a
person with such an ownership or
control interest in the disclosing
entity; and
(B) with a surety bond in a form specified by
the Secretary and in an amount that is not less
than $50,000 that the Secretary determines is
commensurate with the volume of the billing of
the supplier.
The Secretary may waive the requirement of a bond under
subparagraph (B) in the case of a supplier that
provides a comparable surety bond under State law. The
Secretary, at the Secretary's discretion, may impose
the requirements of the first sentence with respect to
some or all providers of items or services under part A
or some or all suppliers or other persons (other than
physicians or other practitioners, as defined in
section 1842(b)(18)(C)) who furnish items or services
under this part.
(17) Prohibition against unsolicited telephone
contacts by suppliers.--
(A) In general.--A supplier of a covered item
under this subsection may not contact an
individual enrolled under this part by
telephone regarding the furnishing of a covered
item to the individual unless 1 of the
following applies:
(i) The individual has given written
permission to the supplier to make
contact by telephone regarding the
furnishing of a covered item.
(ii) The supplier has furnished a
covered item to the individual and the
supplier is contacting the individual
only regarding the furnishing of such
covered item.
(iii) If the contact is regarding the
furnishing of a covered item other than
a covered item already furnished to the
individual, the supplier has furnished
at least 1 covered item to the
individual during the 15-month period
preceding the date on which the
supplier makes such contact.
(B) Prohibiting payment for items furnished
subsequent to unsolicited contacts.--If a
supplier knowingly contacts an individual in
violation of subparagraph (A), no payment may
be made under this part for any item
subsequently furnished to the individual by the
supplier.
(C) Exclusion from program for suppliers
engaging in pattern of unsolicited contacts.--
If a supplier knowingly contacts individuals in
violation of subparagraph (A) to such an extent
that the supplier's conduct establishes a
pattern of contacts in violation of such
subparagraph, the Secretary shall exclude the
supplier from participation in the programs
under this Act, in accordance with the
procedures set forth in subsections (c), (f),
and (g) of section 1128.
(18) Refund of amounts collected for certain
disallowed items.--
(A) In general.--If a nonparticipating
supplier furnishes to an individual enrolled
under this part a covered item for which no
payment may be made under this part by reason
of paragraph (17)(B), the supplier shall refund
on a timely basis to the patient (and shall be
liable to the patient for) any amounts
collected from the patient for the item,
unless--
(i) the supplier establishes that the
supplier did not know and could not
reasonably have been expected to know
that payment may not be made for the
item by reason of paragraph (17)(B), or
(ii) before the item was furnished,
the patient was informed that payment
under this part may not be made for
that item and the patient has agreed to
pay for that item.
(B) Sanctions.--If a supplier knowingly and
willfully fails to make refunds in violation of
subparagraph (A), the Secretary may apply
sanctions against the supplier in accordance
with section 1842(j)(2).
(C) Notice.--Each carrier with a contract in
effect under this part with respect to
suppliers of covered items shall send any
notice of denial of payment for covered items
by reason of paragraph (17)(B) and for which
payment is not requested on an assignment-
related basis to the supplier and the patient
involved.
(D) Timely basis defined.--A refund under
subparagraph (A) is considered to be on a
timely basis only if--
(i) in the case of a supplier who
does not request reconsideration or
seek appeal on a timely basis, the
refund is made within 30 days after the
date the supplier receives a denial
notice under subparagraph (C), or
(ii) in the case in which such a
reconsideration or appeal is taken, the
refund is made within 15 days after the
date the supplier receives notice of an
adverse determination on
reconsideration or appeal.
(19) Certain upgraded items.--
(A) Individual's right to choose upgraded
item.--Notwithstanding any other provision of
this title, the Secretary may issue regulations
under which an individual may purchase or rent
from a supplier an item of upgraded durable
medical equipment for which payment would be
made under this subsection if the item were a
standard item.
(B) Payments to supplier.--In the case of the
purchase or rental of an upgraded item under
subparagraph (A)--
(i) the supplier shall receive
payment under this subsection with
respect to such item as if such item
were a standard item; and
(ii) the individual purchasing or
renting the item shall pay the supplier
an amount equal to the difference
between the supplier's charge and the
amount under clause (i).
In no event may the supplier's charge for an
upgraded item exceed the applicable fee
schedule amount (if any) for such item.
(C) Consumer protection safeguards.--Any
regulations under subparagraph (A) shall
provide for consumer protection standards with
respect to the furnishing of upgraded equipment
under subparagraph (A). Such regulations shall
provide for--
(i) determination of fair market
prices with respect to an upgraded
item;
(ii) full disclosure of the
availability and price of standard
items and proof of receipt of such
disclosure information by the
beneficiary before the furnishing of
the upgraded item;
(iii) conditions of participation for
suppliers in the billing arrangement;
(iv) sanctions of suppliers who are
determined to engage in coercive or
abusive practices, including exclusion;
and
(v) such other safeguards as the
Secretary determines are necessary.
(20) Identification of quality standards.--
(A) In general.--Subject to subparagraph (C),
the Secretary shall establish and implement
quality standards for suppliers of items and
services described in subparagraph (D) to be
applied by recognized independent accreditation
organizations (as designated under subparagraph
(B)) and with which such suppliers shall be
required to comply in order to--
(i) furnish any such item or service
for which payment is made under this
part; and
(ii) receive or retain a provider or
supplier number used to submit claims
for reimbursement for any such item or
service for which payment may be made
under this title.
(B) Designation of independent accreditation
organizations.--Not later than the date that is
1 year after the date on which the Secretary
implements the quality standards under
subparagraph (A), notwithstanding section
1865(a), the Secretary shall designate and
approve one or more independent accreditation
organizations for purposes of such
subparagraph.
(C) Quality standards.--The quality standards
described in subparagraph (A) may not be less
stringent than the quality standards that would
otherwise apply if this paragraph did not apply
and shall include consumer services standards.
(D) Items and services described.--The items
and services described in this subparagraph are
the following items and services, as the
Secretary determines appropriate:
(i) Covered items (as defined in
paragraph (13)) for which payment may
otherwise be made under this
subsection.
(ii) Prosthetic devices and orthotics
and prosthetics described in section
1834(h)(4).
(iii) Items and services described in
section 1842(s)(2).
(E) Implementation.--The Secretary may
establish by program instruction or otherwise
the quality standards under this paragraph,
including subparagraph (F), after consultation
with representatives of relevant parties. Such
standards shall be applied prospectively and
shall be published on the Internet website of
the Centers for Medicare & Medicaid Services.
(F) Application of accreditation
requirement.--In implementing quality standards
under this paragraph--
(i) subject to clause (ii) and
subparagraph (G), the Secretary shall
require suppliers furnishing items and
services described in subparagraph (D)
on or after October 1, 2009, directly
or as a subcontractor for another
entity, to have submitted to the
Secretary evidence of accreditation by
an accreditation organization
designated under subparagraph (B) as
meeting applicable quality standards,
except that the Secretary shall not
require under this clause pharmacies to
obtain such accreditation before
January 1, 2010, except that the
Secretary shall not require a pharmacy
to have submitted to the Secretary such
evidence of accreditation prior to
January 1, 2011; and
(ii) in applying such standards and
the accreditation requirement of clause
(i) with respect to eligible
professionals (as defined in section
1848(k)(3)(B)), and including such
other persons, such as orthotists and
prosthetists, as specified by the
Secretary, furnishing such items and
services--
(I) such standards and
accreditation requirement shall
not apply to such professionals
and persons unless the
Secretary determines that the
standards being applied are
designed specifically to be
applied to such professionals
and persons; and
(II) the Secretary may exempt
such professionals and persons
from such standards and
requirement if the Secretary
determines that licensing,
accreditation, or other
mandatory quality requirements
apply to such professionals and
persons with respect to the
furnishing of such items and
services.
(G) Application of accreditation requirement
to certain pharmacies.--
(i) In general.--With respect to
items and services furnished on or
after January 1, 2011, in implementing
quality standards under this
paragraph--
(I) subject to subclause
(II), in applying such
standards and the accreditation
requirement of subparagraph
(F)(i) with respect to
pharmacies described in clause
(ii) furnishing such items and
services, such standards and
accreditation requirement shall
not apply to such pharmacies;
and
(II) the Secretary may apply
to such pharmacies an
alternative accreditation
requirement established by the
Secretary if the Secretary
determines such alternative
accreditation requirement is
more appropriate for such
pharmacies.
(ii) Pharmacies described.--A
pharmacy described in this clause is a
pharmacy that meets each of the
following criteria:
(I) The total billings by the
pharmacy for such items and
services under this title are
less than 5 percent of total
pharmacy sales, as determined
based on the average total
pharmacy sales for the previous
3 calendar years, 3 fiscal
years, or other yearly period
specified by the Secretary.
(II) The pharmacy has been
enrolled under section 1866(j)
as a supplier of durable
medical equipment, prosthetics,
orthotics, and supplies, has
been issued (which may include
the renewal of) a provider
number for at least 5 years,
and for which a final adverse
action (as defined in section
424.57(a) of title 42, Code of
Federal Regulations) has not
been imposed in the past 5
years.
(III) The pharmacy submits to
the Secretary an attestation,
in a form and manner, and at a
time, specified by the
Secretary, that the pharmacy
meets the criteria described in
subclauses (I) and (II). Such
attestation shall be subject to
section 1001 of title 18,
United States Code.
(IV) The pharmacy agrees to
submit materials as requested
by the Secretary, or during the
course of an audit conducted on
a random sample of pharmacies
selected annually, to verify
that the pharmacy meets the
criteria described in
subclauses (I) and (II).
Materials submitted under the
preceding sentence shall
include a certification by an
accountant on behalf of the
pharmacy or the submission of
tax returns filed by the
pharmacy during the relevant
periods, as requested by the
Secretary.
(21) Special payment rule for specified items and
supplies.--
(A) In general.--Notwithstanding the
preceding provisions of this subsection, for
specified items and supplies (described in
subparagraph (B)) furnished during 2005, the
payment amount otherwise determined under this
subsection for such specified items and
supplies shall be reduced by the percentage
difference between--
(i) the amount of payment otherwise
determined for the specified item or
supply under this subsection for 2002,
and
(ii) the amount of payment for the
specified item or supply under chapter
89 of title 5, United States Code, as
identified in the column entitled
``Median FEHP Price'' in the table
entitled ``SUMMARY OF MEDICARE PRICES
COMPARED TO VA, MEDICAID, RETAIL, AND
FEHP PRICES FOR 16 ITEMS'' included in
the Testimony of the Inspector General
before the Senate Committee on
Appropriations, June 12, 2002, or any
subsequent report by the Inspector
General.
(B) Specified item or supply described.--For
purposes of subparagraph (A), a specified item
or supply means oxygen and oxygen equipment,
standard wheelchairs (including standard power
wheelchairs), nebulizers, diabetic supplies
consisting of lancets and testing strips,
hospital beds, and air mattresses, but only if
the HCPCS code for the item or supply is
identified in a table referred to in
subparagraph (A)(ii).
(C) Application of update to special payment
amount.--The covered item update under
paragraph (14) for specified items and supplies
for 2006 and each subsequent year shall be
applied to the payment amount under
subparagraph (A) unless payment is made for
such items and supplies under section 1847.
(22) Special payment rule for diabetic supplies.--
Notwithstanding the preceding provisions of this
subsection, for purposes of determining the payment
amount under this subsection for diabetic supplies
furnished on or after the first day of the calendar
quarter during 2013 that is at least 30 days after the
date of the enactment of this paragraph and before the
date described in paragraph (1)(H)(ii), the Secretary
shall recalculate and apply the covered item update
under paragraph (14) as if subparagraph (J)(i) of such
paragraph was amended by striking ``but only if
furnished through mail order''.
(b) Fee Schedules for Radiologist Services.--
(1) Development.--The Secretary shall develop--
(A) a relative value scale to serve as the
basis for the payment for radiologist services
under this part, and
(B) using such scale and appropriate
conversion factors and subject to subsection
(c)(1)(A), fee schedules (on a regional,
statewide, locality, or carrier service area
basis) for payment for radiologist services
under this part, to be implemented for such
services furnished during 1989.
(2) Consultation.--In carrying out paragraph (1), the
Secretary shall regularly consult closely with the
Physician Payment Review Commission, the American
College of Radiology, and other organizations
representing physicians or suppliers who furnish
radiologist services and shall share with them the data
and data analysis being used to make the determinations
under paragraph (1), including data on variations in
current medicare payments by geographic area, and by
service and physician specialty.
(3) Considerations.--In developing the relative value
scale and fee schedules under paragraph (1), the
Secretary--
(A) shall take into consideration variations
in the cost of furnishing such services among
geographic areas and among different sites
where services are furnished, and
(B) may also take into consideration such
other factors respecting the manner in which
physicians in different specialties furnish
such services as may be appropriate to assure
that payment amounts are equitable and designed
to promote effective and efficient provision of
radiologist services by physicians in the
different specialties.
(4) Savings.--
(A) Budget neutral fee schedules.--The
Secretary shall develop preliminary fee
schedules for 1989, which are designed to
result in the same amount of aggregate payments
(net of any coinsurance and deductibles under
sections 1833(a)(1)(J) and 1833(b)) for
radiologist services furnished in 1989 as would
have been made if this subsection had not been
enacted.
(B) Initial savings.--The fee schedules
established for payment purposes under this
subsection for services furnished in 1989 shall
be 97 percent of the amounts permitted under
these preliminary fee schedules developed under
subparagraph (A).
(C) 1990 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1990, after
March 31 of such year, the conversion factors
used under this subsection shall be 96 percent
of the conversion factors that applied under
this subsection as of December 31, 1989.
(D) 1991 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1991, the
conversion factors used in a locality under
this subsection shall, subject to clause (vii),
be reduced to the adjusted conversion factor
for the locality determined as follows:
(i) National weighted average
conversion factor.--The Secretary shall
estimate the national weighted average
of the conversion factors used under
this subsection for services furnished
during 1990 beginning on April 1, using
the best available data.
(ii) Reduced national weighted
average.--The national weighted average
estimated under clause (i) shall be
reduced by 13 percent.
(iii) Computation of 1990 locality
index relative to national average.--
The Secretary shall establish an index
which reflects, for each locality, the
ratio of the conversion factor used in
the locality under this subsection to
the national weighted average estimated
under clause (i).
(iv) Adjusted conversion factor.--The
adjusted conversion factor for the
professional or technical component of
a service in a locality is the sum of
\1/2\ of the locally-adjusted amount
determined under clause (v) and \1/2\
of the GPCI-adjusted amount determined
under clause (vi).
(v) Locally-adjusted amount.--For
purposes of clause (iv), the locally
adjusted amount determined under this
clause is the product of (I) the
national weighted average conversion
factor computed under clause (ii), and
(II) the index value established under
clause (iii) for the locality.
(vi) GPCI-adjusted amount.--For
purposes of clause (iv), the GPCI-
adjusted amount determined under this
clause is the sum of--
(I) the product of (a) the
portion of the reduced national
weighted average conversion
factor computed under clause
(ii) which is attributable to
physician work and (b) the
geographic work index value for
the locality (specified in
Addendum C to the Model Fee
Schedule for Physician Services
(published on September 4,
1990, 55 Federal Register pp.
36238-36243)); and
(II) the product of (a) the
remaining portion of the
reduced national weighted
average conversion factor
computed under clause (ii), and
(b) the geographic practice
cost index value specified in
section 1842(b)(14)(C)(iv) for
the locality.
In applying this clause with respect to
the professional component of a
service, 80 percent of the conversion
factor shall be considered to be
attributable to physician work and with
respect to the technical component of
the service, 0 percent shall be
considered to be attributable to
physician work.
(vii) Limits on conversion factor.--
The conversion factor to be applied to
a locality to the professional or
technical component of a service shall
not be reduced under this subparagraph
by more than 9.5 percent below the
conversion factor applied in the
locality under subparagraph (C) to such
component, but in no case shall the
conversion factor be less than 60
percent of the national weighted
average of the conversion factors
(computed under clause (i)).
(E) Rule for certain scanning services.--In
the case of the technical components of
magnetic resonance imaging (MRI) services and
computer assisted tomography (CAT) services
furnished after December 31, 1990, the amount
otherwise payable shall be reduced by 10
percent.
(F) Subsequent updating.--For radiologist
services furnished in subsequent years, the fee
schedules shall be the schedules for the
previous year updated by the percentage
increase in the MEI (as defined in section
1842(i)(3)) for the year.
(G) Nonparticipating physicians and
suppliers.--Each fee schedule so established
shall provide that the payment rate recognized
for nonparticipating physicians and suppliers
is equal to the appropriate percent (as defined
in section 1842(b)(4)(A)(iv)) of the payment
rate recognized for participating physicians
and suppliers.
(5) Limiting charges of nonparticipating physicians
and suppliers.--
(A) In general.--In the case of radiologist
services furnished after January 1, 1989, for
which payment is made under a fee schedule
under this subsection, if a nonparticipating
physician or supplier furnishes the service to
an individual entitled to benefits under this
part, the physician or supplier may not charge
the individual more than the limiting charge
(as defined in subparagraph (B)).
(B) Limiting charge defined.--In subparagraph
(A), the term ``limiting charge'' means, with
respect to a service furnished--
(i) in 1989, 125 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1),
(ii) in 1990, 120 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1), and
(iii) after 1990, 115 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1).
(C) Enforcement.--If a physician or supplier
knowingly and willfully bills in violation of
subparagraph (A), the Secretary may apply
sanctions against such physician or supplier in
accordance with section 1842(j)(2) in the same
manner as such sanctions may apply to a
physician.
(6) Radiologist services defined.--For the purposes
of this subsection and section 1833(a)(1)(J), the term
``radiologist services'' only includes radiology
services performed by, or under the direction or
supervision of, a physician--
(A) who is certified, or eligible to be
certified, by the American Board of Radiology,
or
(B) for whom radiology services account for
at least 50 percent of the total amount of
charges made under this part.
(c) Payment and Standards for Screening Mammography.--
(1) In general.--With respect to expenses incurred
for screening mammography (as defined in section
1861(jj)), payment may be made only--
(A) for screening mammography conducted
consistent with the frequency permitted under
paragraph (2); and
(B) if the screening mammography is conducted
by a facility that has a certificate (or
provisional certificate) issued under section
354 of the Public Health Service Act.
(2) Frequency covered.--
(A) In general.--Subject to revision by the
Secretary under subparagraph (B)--
(i) no payment may be made under this
part for screening mammography
performed on a woman under 35 years of
age;
(ii) payment may be made under this
part for only one screening mammography
performed on a woman over 34 years of
age, but under 40 years of age; and
(iii) in the case of a woman over 39
years of age, payment may not be made
under this part for screening
mammography performed within 11 months
following the month in which a previous
screening mammography was performed.
(B) Revision of frequency.--
(i) Review.--The Secretary, in
consultation with the Director of the
National Cancer Institute, shall review
periodically the appropriate frequency
for performing screening mammography,
based on age and such other factors as
the Secretary believes to be pertinent.
(ii) Revision of frequency.--The
Secretary, taking into consideration
the review made under clause (i), may
revise from time to time the frequency
with which screening mammography may be
paid for under this subsection.
(d) Frequency Limits and Payment for Colorectal Cancer
Screening Tests.--
(1) Screening fecal-occult blood tests.--
(A) Payment amount.--The payment amount for
colorectal cancer screening tests consisting of
screening fecal-occult blood tests is equal to
the payment amount established for diagnostic
fecal-occult blood tests under section 1833(h).
(B) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening fecal-
occult blood test--
(i) if the individual is under 50
years of age; or
(ii) if the test is performed within
the 11 months after a previous
screening fecal-occult blood test.
(2) Screening flexible sigmoidoscopies.--
(A) Fee schedule.--With respect to colorectal
cancer screening tests consisting of screening
flexible sigmoidoscopies, payment under section
1848 shall be consistent with payment under
such section for similar or related services.
(B) Payment limit.--In the case of screening
flexible sigmoidoscopy services, payment under
this part shall not exceed such amount as the
Secretary specifies, based upon the rates
recognized for diagnostic flexible
sigmoidoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
flexible sigmoidoscopy services
furnished on or after January 1, 1999,
that--
(I) in accordance with
regulations, may be performed
in an ambulatory surgical
center and for which the
Secretary permits ambulatory
surgical center payments under
this part, and
(II) are performed in an
ambulatory surgical center or
hospital outpatient department,
payment under this part shall be based
on the lesser of the amount under the
fee schedule that would apply to such
services if they were performed in a
hospital outpatient department in an
area or the amount under the fee
schedule that would apply to such
services if they were performed in an
ambulatory surgical center in the same
area.
(ii) Limitation on coinsurance.--
Subject to section 1833(a)(1)(Y), but
notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable copayment,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--
Subject to section 1833(a)(1)(Y), if during the
course of such screening flexible
sigmoidoscopy, a lesion or growth is detected
which results in a biopsy or removal of the
lesion or growth, payment under this part shall
not be made for the screening flexible
sigmoidoscopy but shall be made for the
procedure classified as a flexible
sigmoidoscopy with such biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
flexible sigmoidoscopy--
(i) if the individual is under 50
years of age; or
(ii) if the procedure is performed
within the 47 months after a previous
screening flexible sigmoidoscopy or, in
the case of an individual who is not at
high risk for colorectal cancer, if the
procedure is performed within the 119
months after a previous screening
colonoscopy.
(3) Screening colonoscopy.--
(A) Fee schedule.--With respect to colorectal
cancer screening test consisting of a screening
colonoscopy, payment under section 1848 shall
be consistent with payment amounts under such
section for similar or related services.
(B) Payment limit.--In the case of screening
colonoscopy services, payment under this part
shall not exceed such amount as the Secretary
specifies, based upon the rates recognized for
diagnostic colonoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
colonoscopy services furnished on or
after January 1, 1999, that are
performed in an ambulatory surgical
center or a hospital outpatient
department, payment under this part
shall be based on the lesser of the
amount under the fee schedule that
would apply to such services if they
were performed in a hospital outpatient
department in an area or the amount
under the fee schedule that would apply
to such services if they were performed
in an ambulatory surgical center in the
same area.
(ii) Limitation on coinsurance.--
Subject to section 1833(a)(1)(Y), but
notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable coinsurance,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--
Subject to section 1833(a)(1)(Y), if during the
course of such screening colonoscopy, a lesion
or growth is detected which results in a biopsy
or removal of the lesion or growth, payment
under this part shall not be made for the
screening colonoscopy but shall be made for the
procedure classified as a colonoscopy with such
biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
colonoscopy for individuals at high risk for
colorectal cancer if the procedure is performed
within the 23 months after a previous screening
colonoscopy or for other individuals if the
procedure is performed within the 119 months
after a previous screening colonoscopy or
within 47 months after a previous screening
flexible sigmoidoscopy.
(e) Accreditation Requirement for Advanced Diagnostic Imaging
Services.--
(1) In general.--
(A) In general.--Beginning with January 1,
2012, with respect to the technical component
of advanced diagnostic imaging services for
which payment is made under the fee schedule
established under section 1848(b) and that are
furnished by a supplier, payment may only be
made if such supplier is accredited by an
accreditation organization designated by the
Secretary under paragraph (2)(B)(i).
(B) Advanced diagnostic imaging services
defined.--In this subsection, the term
``advanced diagnostic imaging services''
includes--
(i) diagnostic magnetic resonance
imaging, computed tomography, and
nuclear medicine (including positron
emission tomography); and
(ii) such other diagnostic imaging
services, including services described
in section 1848(b)(4)(B) (excluding X-
ray, ultrasound, and fluoroscopy), as
specified by the Secretary in
consultation with physician specialty
organizations and other stakeholders.
(C) Supplier defined.--In this subsection,
the term ``supplier'' has the meaning given
such term in section 1861(d).
(2) Accreditation organizations.--
(A) Factors for designation of accreditation
organizations.--The Secretary shall consider
the following factors in designating
accreditation organizations under subparagraph
(B)(i) and in reviewing and modifying the list
of accreditation organizations designated
pursuant to subparagraph (C):
(i) The ability of the organization
to conduct timely reviews of
accreditation applications.
(ii) Whether the organization has
established a process for the timely
integration of new advanced diagnostic
imaging services into the
organization's accreditation program.
(iii) Whether the organization uses
random site visits, site audits, or
other strategies for ensuring
accredited suppliers maintain adherence
to the criteria described in paragraph
(3).
(iv) The ability of the organization
to take into account the capacities of
suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
(v) Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
(vi) Such other factors as the
Secretary determines appropriate.
(B) Designation.--Not later than January 1,
2010, the Secretary shall designate
organizations to accredit suppliers furnishing
the technical component of advanced diagnostic
imaging services. The list of accreditation
organizations so designated may be modified
pursuant to subparagraph (C).
(C) Review and modification of list of
accreditation organizations.--
(i) In general.--The Secretary shall
review the list of accreditation
organizations designated under
subparagraph (B) taking into account
the factors under subparagraph (A).
Taking into account the results of such
review, the Secretary may, by
regulation, modify the list of
accreditation organizations designated
under subparagraph (B).
(ii) Special rule for accreditations
done prior to removal from list of
designated accreditation
organizations.--In the case where the
Secretary removes an organization from
the list of accreditation organizations
designated under subparagraph (B), any
supplier that is accredited by the
organization during the period
beginning on the date on which the
organization is designated as an
accreditation organization under
subparagraph (B) and ending on the date
on which the organization is removed
from such list shall be considered to
have been accredited by an organization
designated by the Secretary under
subparagraph (B) for the remaining
period such accreditation is in effect.
(3) Criteria for accreditation.--The Secretary shall
establish procedures to ensure that the criteria used
by an accreditation organization designated under
paragraph (2)(B) to evaluate a supplier that furnishes
the technical component of advanced diagnostic imaging
services for the purpose of accreditation of such
supplier is specific to each imaging modality. Such
criteria shall include--
(A) standards for qualifications of medical
personnel who are not physicians and who
furnish the technical component of advanced
diagnostic imaging services;
(B) standards for qualifications and
responsibilities of medical directors and
supervising physicians, including standards
that recognize the considerations described in
paragraph (4);
(C) procedures to ensure that equipment used
in furnishing the technical component of
advanced diagnostic imaging services meets
performance specifications;
(D) standards that require the supplier have
procedures in place to ensure the safety of
persons who furnish the technical component of
advanced diagnostic imaging services and
individuals to whom such services are
furnished;
(E) standards that require the establishment
and maintenance of a quality assurance and
quality control program by the supplier that is
adequate and appropriate to ensure the
reliability, clarity, and accuracy of the
technical quality of diagnostic images produced
by such supplier; and
(F) any other standards or procedures the
Secretary determines appropriate.
(4) Recognition in standards for the evaluation of
medical directors and supervising physicians.--The
standards described in paragraph (3)(B) shall recognize
whether a medical director or supervising physician--
(A) in a particular specialty receives
training in advanced diagnostic imaging
services in a residency program;
(B) has attained, through experience, the
necessary expertise to be a medical director or
a supervising physician;
(C) has completed any continuing medical
education courses relating to such services; or
(D) has met such other standards as the
Secretary determines appropriate.
(5) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2010, by an accreditation
organization designated by the Secretary under
paragraph (2)(B) as of January 1, 2010, such supplier
shall be considered to have been accredited by an
organization designated by the Secretary under such
paragraph as of January 1, 2012, for the remaining
period such accreditation is in effect.
(f) Reduction in Payments for Physician Pathology Services
During 1991.--
(1) In general.--For physician pathology services
furnished under this part during 1991, the prevailing
charges used in a locality under this part shall be 7
percent below the prevailing charges used in the
locality under this part in 1990 after March 31.
(2) Limitation.--The prevailing charge for the
technical and professional components of an physician
pathology service furnished by a physician through an
independent laboratory shall not be reduced pursuant to
paragraph (1) to the extent that such reduction would
reduce such prevailing charge below 115 percent of the
prevailing charge for the professional component of
such service when furnished by a hospital-based
physician in the same locality. For purposes of the
preceding sentence, an independent laboratory is a
laboratory that is independent of a hospital and
separate from the attending or consulting physicians'
office.
(g) Payment for Outpatient Critical Access Hospital
Services.--
(1) In general.--The amount of payment for outpatient
critical access hospital services of a critical access
hospital is equal to 101 percent of the reasonable
costs of the hospital in providing such services,
unless the hospital makes the election under paragraph
(2).
(2) Election of cost-based hospital outpatient
service payment plus fee schedule for professional
services.--A critical access hospital may elect to be
paid for outpatient critical access hospital services
amounts equal to the sum of the following, less the
amount that such hospital may charge as described in
section 1866(a)(2)(A):
(A) Facility fee.--With respect to facility
services, not including any services for which
payment may be made under subparagraph (B), 101
percent of the reasonable costs of the critical
access hospital in providing such services.
(B) Fee schedule for professional services.--
With respect to professional services otherwise
included within outpatient critical access
hospital services, 115 percent of such amounts
as would otherwise be paid under this part if
such services were not included in outpatient
critical access hospital services. Subsections
(x) and (y) of section 1833 shall not be taken
into account in determining the amounts that
would otherwise be paid pursuant to the
preceding sentence.
The Secretary may not require, as a condition for
applying subparagraph (B) with respect to a critical
access hospital, that each physician or other
practitioner providing professional services in the
hospital must assign billing rights with respect to
such services, except that such subparagraph shall not
apply to those physicians and practitioners who have
not assigned such billing rights.
(3) Disregarding charges.--The payment amounts under
this subsection shall be determined without regard to
the amount of the customary or other charge.
(4) Treatment of clinical diagnostic laboratory
services.--No coinsurance, deductible, copayment, or
other cost-sharing otherwise applicable under this part
shall apply with respect to clinical diagnostic
laboratory services furnished as an outpatient critical
access hospital service. Nothing in this title shall be
construed as providing for payment for clinical
diagnostic laboratory services furnished as part of
outpatient critical access hospital services, other
than on the basis described in this subsection. For
purposes of the preceding sentence and section
1861(mm)(3), clinical diagnostic laboratory services
furnished by a critical access hospital shall be
treated as being furnished as part of outpatient
critical access services without regard to whether the
individual with respect to whom such services are
furnished is physically present in the critical access
hospital, or in a skilled nursing facility or a clinic
(including a rural health clinic) that is operated by a
critical access hospital, at the time the specimen is
collected.
(5) Coverage of costs for certain emergency room on-
call providers.--In determining the reasonable costs of
outpatient critical access hospital services under
paragraphs (1) and (2)(A), the Secretary shall
recognize as allowable costs, amounts (as defined by
the Secretary) for reasonable compensation and related
costs for physicians, physician assistants, nurse
practitioners, and clinical nurse specialists who are
on-call (as defined by the Secretary) to provide
emergency services but who are not present on the
premises of the critical access hospital involved, and
are not otherwise furnishing services covered under
this title and are not on-call at any other provider or
facility.
(h) Payment for Prosthetic Devices and Orthotics and
Prosthetics.--
(1) General rule for payment.--
(A) In general.--Payment under this
subsection for prosthetic devices and orthotics
and prosthetics shall be made in a lump-sum
amount for the purchase of the item in an
amount equal to 80 percent of the payment basis
described in subparagraph (B).
(B) Payment basis.--Except as provided in
subparagraphs (C), (E), and (H)(i), the payment
basis described in this subparagraph is the
lesser of--
(i) the actual charge for the item;
or
(ii) the amount recognized under
paragraph (2) as the purchase price for
the item.
(C) Exception for certain public home health
agencies.--Subparagraph (B)(i) shall not apply
to an item furnished by a public home health
agency (or by another home health agency which
demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(D) Exclusive payment rule.--Subject to
subparagraph (H)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for prosthetic devices,
orthotics, and prosthetics under this part or
under part A to a home health agency.
(E) Exception for certain items.--Payment for
ostomy supplies, tracheostomy supplies, and
urologicals shall be made in accordance with
subparagraphs (B) and (C) of section
1834(a)(2).
(F) Special payment rules for certain
prosthetics and custom-fabricated orthotics.--
(i) In general.--No payment shall be
made under this subsection for an item
of custom-fabricated orthotics
described in clause (ii) or for an item
of prosthetics unless such item is--
(I) furnished by a qualified
practitioner; and
(II) fabricated by a
qualified practitioner or a
qualified supplier at a
facility that meets such
criteria as the Secretary
determines appropriate.
(ii) Description of custom-fabricated
item.--
(I) In general.--An item
described in this clause is an
item of custom-fabricated
orthotics that requires
education, training, and
experience to custom-fabricate
and that is included in a list
established by the Secretary in
subclause (II). Such an item
does not include shoes and shoe
inserts.
(II) List of items.--The
Secretary, in consultation with
appropriate experts in
orthotics (including national
organizations representing
manufacturers of orthotics),
shall establish and update as
appropriate a list of items to
which this subparagraph
applies. No item may be
included in such list unless
the item is individually
fabricated for the patient over
a positive model of the
patient.
(iii) Qualified practitioner
defined.--In this subparagraph, the
term ``qualified practitioner'' means a
physician or other individual who--
(I) is a qualified physical
therapist or a qualified
occupational therapist;
(II) in the case of a State
that provides for the licensing
of orthotics and prosthetics,
is licensed in orthotics or
prosthetics by the State in
which the item is supplied; or
(III) in the case of a State
that does not provide for the
licensing of orthotics and
prosthetics, is specifically
trained and educated to provide
or manage the provision of
prosthetics and custom-designed
or -fabricated orthotics, and
is certified by the American
Board for Certification in
Orthotics and Prosthetics, Inc.
or by the Board for Orthotist/
Prosthetist Certification, or
is credentialed and approved by
a program that the Secretary
determines, in consultation
with appropriate experts in
orthotics and prosthetics, has
training and education
standards that are necessary to
provide such prosthetics and
orthotics.
(iv) Qualified supplier defined.--In
this subparagraph, the term ``qualified
supplier'' means any entity that is
accredited by the American Board for
Certification in Orthotics and
Prosthetics, Inc. or by the Board for
Orthotist/Prosthetist Certification, or
accredited and approved by a program
that the Secretary determines has
accreditation and approval standards
that are essentially equivalent to
those of such Board.
(G) Replacement of prosthetic devices and
parts.--
(i) In general.--Payment shall be
made for the replacement of prosthetic
devices which are artificial limbs, or
for the replacement of any part of such
devices, without regard to continuous
use or useful lifetime restrictions if
an ordering physician determines that
the provision of a replacement device,
or a replacement part of such a device,
is necessary because of any of the
following:
(I) A change in the
physiological condition of the
patient.
(II) An irreparable change in
the condition of the device, or
in a part of the device.
(III) The condition of the
device, or the part of the
device, requires repairs and
the cost of such repairs would
be more than 60 percent of the
cost of a replacement device,
or, as the case may be, of the
part being replaced.
(ii) Confirmation may be required if
device or part being replaced is less
than 3 years old.--If a physician
determines that a replacement device,
or a replacement part, is necessary
pursuant to clause (i)--
(I) such determination shall
be controlling; and
(II) such replacement device
or part shall be deemed to be
reasonable and necessary for
purposes of section
1862(a)(1)(A);
except that if the device, or part,
being replaced is less than 3 years old
(calculated from the date on which the
beneficiary began to use the device or
part), the Secretary may also require
confirmation of necessity of the
replacement device or replacement part,
as the case may be.
(H) Application of competitive acquisition to
orthotics; limitation of inherent
reasonableness authority.--In the case of
orthotics described in paragraph (2)(C) of
section 1847(a) furnished on or after January
1, 2011, subject to subsection (a)(1)(G), that
are included in a competitive acquisition
program in a competitive acquisition area under
such section--
(i) the payment basis under this
subsection for such orthotics furnished
in such area shall be the payment basis
determined under such competitive
acquisition program; and
(ii) subject to subsection (a)(1)(G),
the Secretary may use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847,
and in the case of such adjustment,
paragraphs (8) and (9) of section
1842(b) shall not be applied.
(2) Purchase price recognized.--For purposes of
paragraph (1), the amount that is recognized under this
paragraph as the purchase price for prosthetic devices,
orthotics, and prosthetics is the amount described in
subparagraph (C) of this paragraph, determined as
follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price for each item
equal to the average reasonable charge
in the locality for the purchase of the
item for the 12-month period ending
with June 1987.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(United States city average)
for the 6-month period ending
with December 1987, or
(II) in 1991, 1992 or 1993,
equal to the local purchase
price computed under this
clause for the previous year
increased by the applicable
percentage increase for the
year.
(B) Computation of regional purchase price.--
With respect to the furnishing of a particular
item in each region (as defined by the
Secretary), the Secretary shall compute a
regional purchase price--
(i) for 1992, equal to the average
(weighted by relative volume of all
claims among carriers) of the local
purchase prices for the carriers in the
region computed under subparagraph
(A)(ii)(II) for the year, and
(ii) for each subsequent year, equal
to the regional purchase price computed
under this subparagraph for the
previous year increased by the
applicable percentage increase for the
year.
(C) Purchase price recognized.--For purposes
of paragraph (1) and subject to subparagraph
(D), the amount that is recognized under this
paragraph as the purchase price for each item
furnished--
(i) in 1989, 1990, or 1991, is 100
percent of the local purchase price
computed under subparagraph (A)(ii);
(ii) in 1992, is the sum of (I) 75
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1992, and (II) 25 percent of the
regional purchase price computed under
subparagraph (B) for 1992;
(iii) in 1993, is the sum of (I) 50
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1993, and (II) 50 percent of the
regional purchase price computed under
subparagraph (B) for 1993; and
(iv) in 1994 or a subsequent year, is
the regional purchase price computed
under subparagraph (B) for that year.
(D) Range on amount recognized.--The amount
that is recognized under subparagraph (C) as
the purchase price for an item furnished--
(i) in 1992, may not exceed 125
percent, and may not be lower than 85
percent, of the average of the purchase
prices recognized under such
subparagraph for all the carrier
service areas in the United States in
that year; and
(ii) in a subsequent year, may not
exceed 120 percent, and may not be
lower than 90 percent, of the average
of the purchase prices recognized under
such subparagraph for all the carrier
service areas in the United States in
that year.
(3) Applicability of certain provisions relating to
durable medical equipment.--Paragraphs (12) and (17)
and subparagraphs (A) and (B) of paragraph (10) and
paragraph (11) of subsection (a) shall apply to
prosthetic devices, orthotics, and prosthetics in the
same manner as such provisions apply to covered items
under such subsection.
(4) Definitions.--In this subsection--
(A) the term ``applicable percentage
increase'' means--
(i) for 1991, 0 percent;
(ii) for 1992 and 1993, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(iii) for 1994 and 1995, 0 percent;
(iv) for 1996 and 1997, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(v) for each of the years 1998
through 2000, 1 percent;
(vi) for 2001, the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 12-month period ending
with June 2000;
(vii) for 2002, 1 percent;
(viii) for 2003, the percentage
increase in the consumer price index
for all urban consumers (United States
city average) for the 12-month period
ending with June of the previous year;
(ix) for 2004, 2005, and 2006, 0
percent;
(x) for for each of 2007 through
2010, the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year; and
(xi) for 2011 and each subsequent
year--
(I) the percentage increase
in the consumer price index for
all urban consumers (United
States city average) for the
12-month period ending with
June of the previous year,
reduced by--
(II) the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
(B) the term ``prosthetic devices'' has the
meaning given such term in section 1861(s)(8),
except that such term does not include
parenteral and enteral nutrition nutrients,
supplies, and equipment and does not include an
implantable item for which payment may be made
under section 1833(t); and
(C) the term ``orthotics and prosthetics''
has the meaning given such term in section
1861(s)(9) (and includes shoes described in
section 1861(s)(12)), but does not include
intraocular lenses or medical supplies
(including catheters, catheter supplies, ostomy
bags, and supplies related to ostomy care)
furnished by a home health agency under section
1861(m)(5).
The application of subparagraph (A)(xi)(II) may result
in the applicable percentage increase under
subparagraph (A) being less than 0.0 for a year, and
may result in payment rates under this subsection for a
year being less than such payment rates for the
preceding year.
(5) Documentation created by orthotists and
prosthetists.--For purposes of determining the
reasonableness and medical necessity of orthotics and
prosthetics, documentation created by an orthotist or
prosthetist shall be considered part of the
individual's medical record to support documentation
created by eligible professionals described in section
1848(k)(3)(B).
(i) Payment for Surgical Dressings.--
(1) In general.--Payment under this subsection for
surgical dressings (described in section 1861(s)(5))
shall be made in a lump sum amount for the purchase of
the item in an amount equal to 80 percent of the lesser
of--
(A) the actual charge for the item; or
(B) a payment amount determined in accordance
with the methodology described in subparagraphs
(B) and (C) of subsection (a)(2) (except that
in applying such methodology, the national
limited payment amount referred to in such
subparagraphs shall be initially computed based
on local payment amounts using average
reasonable charges for the 12-month period
ending December 31, 1992, increased by the
covered item updates described in such
subsection for 1993 and 1994).
(2) Exceptions.--Paragraph (1) shall not apply to
surgical dressings that are--
(A) furnished as an incident to a physician's
professional service; or
(B) furnished by a home health agency.
(j) Requirements for Suppliers of Medical Equipment and
Supplies.--
(1) Issuance and renewal of supplier number.--
(A) Payment.--Except as provided in
subparagraph (C), no payment may be made under
this part after the date of the enactment of
the Social Security Act Amendments of 1994 for
items furnished by a supplier of medical
equipment and supplies unless such supplier
obtains (and renews at such intervals as the
Secretary may require) a supplier number.
(B) Standards for possessing a supplier
number.--A supplier may not obtain a supplier
number unless--
(i) for medical equipment and
supplies furnished on or after the date
of the enactment of the Social Security
Act Amendments of 1994 and before
January 1, 1996, the supplier meets
standards prescribed by the Secretary
in regulations issued on June 18, 1992;
and
(ii) for medical equipment and
supplies furnished on or after January
1, 1996, the supplier meets revised
standards prescribed by the Secretary
(in consultation with representatives
of suppliers of medical equipment and
supplies, carriers, and consumers) that
shall include requirements that the
supplier--
(I) comply with all
applicable State and Federal
licensure and regulatory
requirements;
(II) maintain a physical
facility on an appropriate
site;
(III) have proof of
appropriate liability
insurance; and
(IV) meet such other
requirements as the Secretary
may specify.
(C) Exception for items furnished as incident
to a physician's service.--Subparagraph (A)
shall not apply with respect to medical
equipment and supplies furnished incident to a
physician's service.
(D) Prohibition against multiple supplier
numbers.--The Secretary may not issue more than
one supplier number to any supplier of medical
equipment and supplies unless the issuance of
more than one number is appropriate to identify
subsidiary or regional entities under the
supplier's ownership or control.
(E) Prohibition against delegation of
supplier determinations.--The Secretary may not
delegate (other than by contract under section
1842) the responsibility to determine whether
suppliers meet the standards necessary to
obtain a supplier number.
(2) Certificates of medical necessity.--
(A) Limitation on information provided by
suppliers on certificates of medical
necessity.--
(i) In general.--Effective 60 days
after the date of the enactment of the
Social Security Act Amendments of 1994,
a supplier of medical equipment and
supplies may distribute to physicians,
or to individuals entitled to benefits
under this part, a certificate of
medical necessity for commercial
purposes which contains no more than
the following information completed by
the supplier:
(I) An identification of the
supplier and the beneficiary to
whom such medical equipment and
supplies are furnished.
(II) A description of such
medical equipment and supplies.
(III) Any product code
identifying such medical
equipment and supplies.
(IV) Any other administrative
information (other than
information relating to the
beneficiary's medical
condition) identified by the
Secretary.
(ii) Information on payment amount
and charges.--If a supplier distributes
a certificate of medical necessity
containing any of the information
permitted to be supplied under clause
(i), the supplier shall also list on
the certificate of medical necessity
the fee schedule amount and the
supplier's charge for the medical
equipment or supplies being furnished
prior to distribution of such
certificate to the physician.
(iii) Penalty.--Any supplier of
medical equipment and supplies who
knowingly and willfully distributes a
certificate of medical necessity in
violation of clause (i) or fails to
provide the information required under
clause (ii) is subject to a civil money
penalty in an amount not to exceed
$1,000 for each such certificate of
medical necessity so distributed. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to
civil money penalties under this
subparagraph in the same manner as they
apply to a penalty or proceeding under
section 1128A(a).
(B) Definition.--For purposes of this
paragraph, the term ``certificate of medical
necessity'' means a form or other document
containing information required by the carrier
to be submitted to show that an item is
reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve
the functioning of a malformed body member.
(3) Coverage and review criteria.--The Secretary
shall annually review the coverage and utilization of
items of medical equipment and supplies to determine
whether such items should be made subject to coverage
and utilization review criteria, and if appropriate,
shall develop and apply such criteria to such items.
(4) Limitation on patient liability.--If a supplier
of medical equipment and supplies (as defined in
paragraph (5))--
(A) furnishes an item or service to a
beneficiary for which no payment may be made by
reason of paragraph (1);
(B) furnishes an item or service to a
beneficiary for which payment is denied in
advance under subsection (a)(15); or
(C) furnishes an item or service to a
beneficiary for which payment is denied under
section 1862(a)(1);
any expenses incurred for items and services furnished
to an individual by such a supplier not on an assigned
basis shall be the responsibility of such supplier. The
individual shall have no financial responsibility for
such expenses and the supplier shall refund on a timely
basis to the individual (and shall be liable to the
individual for) any amounts collected from the
individual for such items or services. The provisions
of subsection (a)(18) shall apply to refunds required
under the previous sentence in the same manner as such
provisions apply to refunds under such subsection.
(5) Definition.--The term ``medical equipment and
supplies'' means--
(A) durable medical equipment (as defined in
section 1861(n));
(B) prosthetic devices (as described in
section 1861(s)(8));
(C) orthotics and prosthetics (as described
in section 1861(s)(9));
(D) surgical dressings (as described in
section 1861(s)(5));
(E) such other items as the Secretary may
determine; and
(F) for purposes of paragraphs (1) and (3)--
(i) home dialysis supplies and
equipment (as described in section
1861(s)(2)(F)),
(ii) immunosuppressive drugs (as
described in section 1861(s)(2)(J)),
(iii) therapeutic shoes for diabetics
(as described in section 1861(s)(12)),
(iv) oral drugs prescribed for use as
an anticancer therapeutic agent (as
described in section 1861(s)(2)(Q)),
and
(v) self-administered erythropoetin
(as described in section
1861(s)(2)(P)).
(k) Payment for Outpatient Therapy Services and Comprehensive
Outpatient Rehabilitation Services.--
(1) In general.--With respect to services described
in section 1833(a)(8) or 1833(a)(9) for which payment
is determined under this subsection, the payment basis
shall be--
(A) for services furnished during 1998, the
amount determined under paragraph (2); or
(B) for services furnished during a
subsequent year, 80 percent of the lesser of--
(i) the actual charge for the
services, or
(ii) the applicable fee schedule
amount (as defined in paragraph (3))
for the services.
(2) Payment in 1998 based upon adjusted reasonable
costs.--The amount under this paragraph for services is
the lesser of--
(A) the charges imposed for the services, or
(B) the adjusted reasonable costs (as defined
in paragraph (4)) for the services,
less 20 percent of the amount of the charges imposed
for such services.
(3) Applicable fee schedule amount.--In this
subsection, the term ``applicable fee schedule amount''
means, with respect to services furnished in a year,
the amount determined under the fee schedule
established under section 1848 for such services
furnished during the year or, if there is no such fee
schedule established for such services, the amount
determined under the fee schedule established for such
comparable services as the Secretary specifies.
(4) Adjusted reasonable costs.--In paragraph (2), the
term ``adjusted reasonable costs'' means, with respect
to any services, reasonable costs determined for such
services, reduced by 10 percent. The 10-percent
reduction shall not apply to services described in
section 1833(a)(8)(B) (relating to services provided by
hospitals).
(5) Uniform coding.--For claims for services
submitted on or after April 1, 1998, for which the
amount of payment is determined under this subsection,
the claim shall include a code (or codes) under a
uniform coding system specified by the Secretary that
identifies the services furnished.
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to therapy services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Adjustment in discount for certain multiple
therapy services.--In the case of therapy services
furnished on or after April 1, 2013, and for which
payment is made under this subsection pursuant to the
applicable fee schedule amount (as defined in paragraph
(3)), instead of the 25 percent multiple procedure
payment reduction specified in the final rule published
by the Secretary in the Federal Register on November
29, 2010, the reduction percentage shall be 50 percent.
(l) Establishment of Fee Schedule for Ambulance Services.--
(1) In general.--The Secretary shall establish a fee
schedule for payment for ambulance services whether
provided directly by a supplier or provider or under
arrangement with a provider under this part through a
negotiated rulemaking process described in title 5,
United States Code, and in accordance with the
requirements of this subsection.
(2) Considerations.--In establishing such fee
schedule, the Secretary shall--
(A) establish mechanisms to control increases
in expenditures for ambulance services under
this part;
(B) establish definitions for ambulance
services which link payments to the type of
services provided;
(C) consider appropriate regional and
operational differences;
(D) consider adjustments to payment rates to
account for inflation and other relevant
factors; and
(E) phase in the application of the payment
rates under the fee schedule in an efficient
and fair manner consistent with paragraph (11),
except that such phase-in shall provide for
full payment of any national mileage rate for
ambulance services provided by suppliers that
are paid by carriers in any of the 50 States
where payment by a carrier for such services
for all such suppliers in such State did not,
prior to the implementation of the fee
schedule, include a separate amount for all
mileage within the county from which the
beneficiary is transported.
(3) Savings.--In establishing such fee schedule, the
Secretary shall--
(A) ensure that the aggregate amount of
payments made for ambulance services under this
part during 2000 does not exceed the aggregate
amount of payments which would have been made
for such services under this part during such
year if the amendments made by section 4531(a)
of the Balanced Budget Act of 1997 continued in
effect, except that in making such
determination the Secretary shall assume an
update in such payments for 2002 equal to
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points;
(B) set the payment amounts provided under
the fee schedule for services furnished in 2001
and each subsequent year at amounts equal to
the payment amounts under the fee schedule for
services furnished during the previous year,
increased, subject to subparagraph (C) and the
succeeding sentence of this paragraph, by the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points; and
(C) for 2011 and each subsequent year, after
determining the percentage increase under
subparagraph (B) for the year, reduce such
percentage increase by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (C) may result in the
percentage increase under subparagraph (B) being less
than 0.0 for a year, and may result in payment rates
under the fee schedule under this subsection for a year
being less than such payment rates for the preceding
year.
(4) Consultation.--In establishing the fee schedule
for ambulance services under this subsection, the
Secretary shall consult with various national
organizations representing individuals and entities who
furnish and regulate ambulance services and share with
such organizations relevant data in establishing such
schedule.
(5) Limitation on review.--There shall be no
administrative or judicial review under section 1869 or
otherwise of the amounts established under the fee
schedule for ambulance services under this subsection,
including matters described in paragraph (2).
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to ambulance services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Coding system.--The Secretary may require the
claim for any services for which the amount of payment
is determined under this subsection to include a code
(or codes) under a uniform coding system specified by
the Secretary that identifies the services furnished.
(8) Services furnished by critical access
hospitals.--Notwithstanding any other provision of this
subsection, the Secretary shall pay 101 percent of the
reasonable costs incurred in furnishing ambulance
services if such services are furnished--
(A) by a critical access hospital (as defined
in section 1861(mm)(1)), or
(B) by an entity that is owned and operated
by a critical access hospital,
but only if the critical access hospital or entity is
the only provider or supplier of ambulance services
that is located within a 35-mile drive of such critical
access hospital.
(9) Transitional assistance for rural providers.--In
the case of ground ambulance services furnished on or
after July 1, 2001, and before January 1, 2004, for
which the transportation originates in a rural area (as
defined in section 1886(d)(2)(D)) or in a rural census
tract of a metropolitan statistical area (as determined
under the most recent modification of the Goldsmith
Modification, originally published in the Federal
Register on February 27, 1992 (57 Fed. Reg. 6725)), the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 17 miles, and up to 50 miles,
the rate otherwise established shall be increased by
not less than \1/2\ of the additional payment per mile
established for the first 17 miles of such a trip
originating in a rural area.
(10) Phase-in providing floor using blend of fee
schedule and regional fee schedules.--In carrying out
the phase-in under paragraph (2)(E) for each level of
ground service furnished in a year, the portion of the
payment amount that is based on the fee schedule shall
be the greater of the amount determined under such fee
schedule (without regard to this paragraph) or the
following blended rate of the fee schedule under
paragraph (1) and of a regional fee schedule for the
region involved:
(A) For 2004 (for services furnished on or
after July 1, 2004), the blended rate shall be
based 20 percent on the fee schedule under
paragraph (1) and 80 percent on the regional
fee schedule.
(B) For 2005, the blended rate shall be based
40 percent on the fee schedule under paragraph
(1) and 60 percent on the regional fee
schedule.
(C) For 2006, the blended rate shall be based
60 percent on the fee schedule under paragraph
(1) and 40 percent on the regional fee
schedule.
(D) For 2007, 2008, and 2009, the blended
rate shall be based 80 percent on the fee
schedule under paragraph (1) and 20 percent on
the regional fee schedule.
(E) For 2010 and each succeeding year, the
blended rate shall be based 100 percent on the
fee schedule under paragraph (1).
For purposes of this paragraph, the Secretary shall
establish a regional fee schedule for each of the nine
census divisions (referred to in section 1886(d)(2))
using the methodology (used in establishing the fee
schedule under paragraph (1)) to calculate a regional
conversion factor and a regional mileage payment rate
and using the same payment adjustments and the same
relative value units as used in the fee schedule under
such paragraph.
(11) Adjustment in payment for certain long trips.--
In the case of ground ambulance services furnished on
or after July 1, 2004, and before January 1, 2009,
regardless of where the transportation originates, the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 50 miles the per mile rate
otherwise established shall be increased by \1/4\ of
the payment per mile otherwise applicable to miles in
excess of 50 miles in such trip.
(12) Assistance for rural providers furnishing
services in low population density areas.--
(A) In general.--In the case of ground
ambulance services furnished on or after July
1, 2004, and before January 1, 2023, for which
the transportation originates in a qualified
rural area (identified under subparagraph
(B)(iii)), the Secretary shall provide for a
percent increase in the base rate of the fee
schedule for a trip established under this
subsection. In establishing such percent
increase, the Secretary shall estimate the
average cost per trip for such services (not
taking into account mileage) in the lowest
quartile as compared to the average cost per
trip for such services (not taking into account
mileage) in the highest quartile of all rural
county populations.
(B) Identification of qualified rural
areas.--
(i) Determination of population
density in area.--Based upon data from
the United States decennial census for
the year 2000, the Secretary shall
determine, for each rural area, the
population density for that area.
(ii) Ranking of areas.--The Secretary
shall rank each such area based on such
population density.
(iii) Identification of qualified
rural areas.--The Secretary shall
identify those areas (in subparagraph
(A) referred to as ``qualified rural
areas'') with the lowest population
densities that represent, if each such
area were weighted by the population of
such area (as used in computing such
population densities), an aggregate
total of 25 percent of the total of the
population of all such areas.
(iv) Rural area.--For purposes of
this paragraph, the term ``rural area''
has the meaning given such term in
section 1886(d)(2)(D). If feasible, the
Secretary shall treat a rural census
tract of a metropolitan statistical
area (as determined under the most
recent modification of the Goldsmith
Modification, originally published in
the Federal Register on February 27,
1992 (57 Fed. Reg. 6725) as a rural
area for purposes of this paragraph.
(v) Judicial review.--There shall be
no administrative or judicial review
under section 1869, 1878, or otherwise,
respecting the identification of an
area under this subparagraph.
(13) Temporary increase for ground ambulance
services.--
(A) In general.--After computing the rates
with respect to ground ambulance services under
the other applicable provisions of this
subsection, in the case of such services
furnished on or after July 1, 2004, and before
January 1, 2007, and for such services
furnished on or after July 1, 2008, and before
January 1, 2023, for which the transportation
originates in--
(i) a rural area described in
paragraph (9) or in a rural census
tract described in such paragraph, the
fee schedule established under this
section shall provide that the rate for
the service otherwise established,
after the application of any increase
under paragraphs (11) and (12), shall
be increased by 2 percent (or 3 percent
if such service is furnished on or
after July 1, 2008, and before January
1, 2023); and
(ii) an area not described in clause
(i), the fee schedule established under
this subsection shall provide that the
rate for the service otherwise
established, after the application of
any increase under paragraph (11),
shall be increased by 1 percent (or 2
percent if such service is furnished on
or after July 1, 2008, and before
January 1, 2023).
(B) Application of increased payments after
applicable period.--The increased payments
under subparagraph (A) shall not be taken into
account in calculating payments for services
furnished after the applicable period specified
in such subparagraph.
(14) Providing appropriate coverage of rural air
ambulance services.--
(A) In general.--The regulations described in
section 1861(s)(7) shall provide, to the extent
that any ambulance services (whether ground or
air) may be covered under such section, that a
rural air ambulance service (as defined in
subparagraph (C)) is reimbursed under this
subsection at the air ambulance rate if the air
ambulance service--
(i) is reasonable and necessary based
on the health condition of the
individual being transported at or
immediately prior to the time of the
transport; and
(ii) complies with equipment and crew
requirements established by the
Secretary.
(B) Satisfaction of requirement of medically
necessary.--The requirement of subparagraph
(A)(i) is deemed to be met for a rural air
ambulance service if--
(i) subject to subparagraph (D), such
service is requested by a physician or
other qualified medical personnel (as
specified by the Secretary) who
certifies or reasonably determines that
the individual's condition is such that
the time needed to transport the
individual by land or the instability
of transportation by land poses a
threat to the individual's survival or
seriously endangers the individual's
health; or
(ii) such service is furnished
pursuant to a protocol that is
established by a State or regional
emergency medical service (EMS) agency
and recognized or approved by the
Secretary under which the use of an air
ambulance is recommended, if such
agency does not have an ownership
interest in the entity furnishing such
service.
(C) Rural air ambulance service defined.--For
purposes of this paragraph, the term ``rural
air ambulance service'' means fixed wing and
rotary wing air ambulance service in which the
point of pick up of the individual occurs in a
rural area (as defined in section
1886(d)(2)(D)) or in a rural census tract of a
metropolitan statistical area (as determined
under the most recent modification of the
Goldsmith Modification, originally published in
the Federal Register on February 27, 1992 (57
Fed. Reg. 6725)).
(D) Limitation.--
(i) In general.--Subparagraph (B)(i)
shall not apply if there is a financial
or employment relationship between the
person requesting the rural air
ambulance service and the entity
furnishing the ambulance service, or an
entity under common ownership with the
entity furnishing the air ambulance
service, or a financial relationship
between an immediate family member of
such requester and such an entity.
(ii) Exception.--Where a hospital and
the entity furnishing rural air
ambulance services are under common
ownership, clause (i) shall not apply
to remuneration (through employment or
other relationship) by the hospital of
the requester or immediate family
member if the remuneration is for
provider-based physician services
furnished in a hospital (as described
in section 1887) which are reimbursed
under part A and the amount of the
remuneration is unrelated directly or
indirectly to the provision of rural
air ambulance services.
(15) Payment adjustment for non-emergency ambulance
transports for esrd beneficiaries.--The fee schedule
amount otherwise applicable under the preceding
provisions of this subsection shall be reduced by 10
percent for ambulance services furnished during the
period beginning on October 1, 2013, and ending on
September 30, 2018, and by 23 percent for such services
furnished on or after October 1, 2018, consisting of
non-emergency basic life support services involving
transport of an individual with end-stage renal disease
for renal dialysis services (as described in section
1881(b)(14)(B)) furnished other than on an emergency
basis by a provider of services or a renal dialysis
facility.
(16) Prior authorization for repetitive scheduled
non-emergent ambulance transports.--
(A) In general.--Beginning January 1, 2017,
if the expansion to all States of the model of
prior authorization described in paragraph (2)
of section 515(a) of the Medicare Access and
CHIP Reauthorization Act of 2015 meets the
requirements described in paragraphs (1)
through (3) of section 1115A(c), then the
Secretary shall expand such model to all
States.
(B) Funding.--The Secretary shall use funds
made available under section 1893(h)(10) to
carry out this paragraph.
(C) Clarification regarding budget
neutrality.--Nothing in this paragraph may be
construed to limit or modify the application of
section 1115A(b)(3)(B) to models described in
such section, including with respect to the
model described in subparagraph (A) and
expanded beginning on January 1, 2017, under
such subparagraph.
(17) Submission of cost and other information.--
(A) Development of data collection system.--
The Secretary shall develop a data collection
system (which may include use of a cost survey)
to collect cost, revenue, utilization, and
other information determined appropriate by the
Secretary with respect to providers of services
(in this paragraph referred to as
``providers'') and suppliers of ground
ambulance services. Such system shall be
designed to collect information--
(i) needed to evaluate the extent to
which reported costs relate to payment
rates under this subsection;
(ii) on the utilization of capital
equipment and ambulance capacity,
including information consistent with
the type of information described in
section 1121(a); and
(iii) on different types of ground
ambulance services furnished in
different geographic locations,
including rural areas and low
population density areas described in
paragraph (12).
(B) Specification of data collection
system.--
(i) In general.--The Secretary
shall--
(I) not later than December
31, 2019, specify the data
collection system under
subparagraph (A); and
(II) identify the providers
and suppliers of ground
ambulance services that would
be required to submit
information under such data
collection system, including
the representative sample
described in clause (ii).
(ii) Determination of representative
sample.--
(I) In general.--Not later
than December 31, 2019, with
respect to the data collection
for the first year under such
system, and for each subsequent
year through 2024, the
Secretary shall determine a
representative sample to submit
information under the data
collection system.
(II) Requirements.--The
sample under subclause (I)
shall be representative of the
different types of providers
and suppliers of ground
ambulance services (such as
those providers and suppliers
that are part of an emergency
service or part of a government
organization) and the
geographic locations in which
ground ambulance services are
furnished (such as urban,
rural, and low population
density areas).
(III) Limitation.--The
Secretary shall not include an
individual provider or supplier
of ground ambulance services in
the sample under subclause (I)
in 2 consecutive years, to the
extent practicable.
(C) Reporting of cost information.--For each
year, a provider or supplier of ground
ambulance services identified by the Secretary
under subparagraph (B)(i)(II) as being required
to submit information under the data collection
system with respect to a period for the year
shall submit to the Secretary information
specified under the system. Such information
shall be submitted in a form and manner, and at
a time, specified by the Secretary for purposes
of this subparagraph.
(D) Payment reduction for failure to
report.--
(i) In general.--Beginning January 1,
2022, subject to clause (ii), a 10
percent reduction to payments under
this subsection shall be made for the
applicable period (as defined in clause
(ii)) to a provider or supplier of
ground ambulance services that--
(I) is required to submit
information under the data
collection system with respect
to a period under subparagraph
(C); and
(II) does not sufficiently
submit such information, as
determined by the Secretary.
(ii) Applicable period defined.--For
purposes of clause (i), the term
``applicable period'' means, with
respect to a provider or supplier of
ground ambulance services, a year
specified by the Secretary not more
than 2 years after the end of the
period with respect to which the
Secretary has made a determination
under clause (i)(II) that the provider
or supplier of ground ambulance
services failed to sufficiently submit
information under the data collection
system.
(iii) Hardship exemption.--The
Secretary may exempt a provider or
supplier from the payment reduction
under clause (i) with respect to an
applicable period in the event of
significant hardship, such as a natural
disaster, bankruptcy, or other similar
situation that the Secretary determines
interfered with the ability of the
provider or supplier of ground
ambulance services to submit such
information in a timely manner for the
specified period.
(iv) Informal review.--The Secretary
shall establish a process under which a
provider or supplier of ground
ambulance services may seek an informal
review of a determination that the
provider or supplier is subject to the
payment reduction under clause (i).
(E) Ongoing data collection.--
(i) Revision of data collection
system.--The Secretary may, as the
Secretary determines appropriate and,
if available, taking into consideration
the report (or reports) under
subparagraph (F), revise the data
collection system under subparagraph
(A).
(ii) Subsequent data collection.--In
order to continue to evaluate the
extent to which reported costs relate
to payment rates under this subsection
and for other purposes the Secretary
deems appropriate, the Secretary shall
require providers and suppliers of
ground ambulance services to submit
information for years after 2024 as the
Secretary determines appropriate, but
in no case less often than once every 3
years.
(F) Ground ambulance data collection system
study.--
(i) In general.--Not later than the
second June 15th following the date on
which the Secretary transmits data for
the first representative sample of
providers and suppliers of ground
ambulance services to the Medicare
Payment Advisory Commission, and as
determined necessary by such Commission
thereafter,, such Commission shall
assess, and submit to Congress a report
on, information submitted by providers
and suppliers of ground ambulance
services through the data collection
system under subparagraph (A), the
adequacy of payments for ground
ambulance services under this
subsection, and geographic variations
in the cost of furnishing such
services.
(ii) Contents.--A report under clause
(i) shall contain the following:
(I) An analysis of
information submitted through
the data collection system.
(II) An analysis of any
burden on providers and
suppliers of ground ambulance
services associated with the
data collection system.
(III) A recommendation as to
whether information should
continue to be submitted
through such data collection
system or if such system should
be revised under subparagraph
(E)(i).
(IV) Other information
determined appropriate by the
Commission.
(G) Public availability.--The Secretary shall
post information on the results of the data
collection under this paragraph on the Internet
website of the Centers for Medicare & Medicaid
Services, as determined appropriate by the
Secretary.
(H) Implementation.--The Secretary shall
implement this paragraph through notice and
comment rulemaking.
(I) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to the
collection of information required under this
subsection.
(J) Limitations on review.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the data
collection system or identification of
respondents under this paragraph.
(K) Funding for implementation.--For purposes
of carrying out subparagraph (A), the Secretary
shall provide for the transfer, from the
Federal Supplementary Medical Insurance Trust
Fund under section 1841, of $15,000,000 to the
Centers for Medicare & Medicaid Services
Program Management Account for fiscal year
2018. Amounts transferred under this
subparagraph shall remain available until
expended.
(m) Payment for Telehealth Services.--
(1) In general.--Subject to paragraphs (8) and (9),
the Secretary shall pay for telehealth services that
are furnished via a telecommunications system by a
physician (as defined in section 1861(r)) or a
practitioner (as defined in paragraph (4)(E)) to an
eligible telehealth individual enrolled under this part
notwithstanding that the individual physician or
practitioner providing the telehealth service is not at
the same location as the beneficiary. For purposes of
the preceding sentence, in the case of any Federal
telemedicine demonstration program conducted in Alaska
or Hawaii, the term ``telecommunications system''
includes store-and-forward technologies that provide
for the asynchronous transmission of health care
information in single or multimedia formats.
(2) Payment amount.--
(A) Distant site.--Subject to paragraph (8),
the Secretary shall pay to a physician or
practitioner located at a distant site that
furnishes a telehealth service to an eligible
telehealth individual an amount equal to the
amount that such physician or practitioner
would have been paid under this title had such
service been furnished without the use of a
telecommunications system.
(B) Facility fee for originating site.--
(i) In general.--Subject to clauses
(ii) and (iii) and paragraph (6)(C),
with respect to a telehealth service,
subject to section 1833(a)(1)(U), there
shall be paid to the originating site a
facility fee equal to--
(I) for the period beginning
on October 1, 2001, and ending
on December 31, 2001, and for
2002, $20; and
(II) for a subsequent year,
the facility fee specified in
subclause (I) or this subclause
for the preceding year
increased by the percentage
increase in the MEI (as defined
in section 1842(i)(3)) for such
subsequent year.
(ii) No facility fee if originating
site is the home.--No facility fee
shall be paid under this subparagraph
to an originating site described in
paragraph (4)(C)(ii)(X).
(iii) No facility fee for new
sites.--With respect to telehealth
services identified in paragraph
(4)(F)(i) as of the date of the
enactment of this clause that are
furnished during the 151-day period
beginning on the first day after the
end of the emergency period described
in section 1135(g)(1)(B), a facility
fee shall only be paid under this
subparagraph to an originating site
that is described in paragraph
(4)(C)(ii) (other than subclause (X) of
such paragraph).
(C) Telepresenter not required.--Nothing in
this subsection shall be construed as requiring
an eligible telehealth individual to be
presented by a physician or practitioner at the
originating site for the furnishing of a
service via a telecommunications system, unless
it is medically necessary (as determined by the
physician or practitioner at the distant site).
(3) Limitation on beneficiary charges.--
(A) Physician and practitioner.--The
provisions of section 1848(g) and subparagraphs
(A) and (B) of section 1842(b)(18) shall apply
to a physician or practitioner receiving
payment under this subsection in the same
manner as they apply to physicians or
practitioners under such sections.
(B) Originating site.--The provisions of
section 1842(b)(18) shall apply to originating
sites receiving a facility fee in the same
manner as they apply to practitioners under
such section.
(4) Definitions.--For purposes of this subsection:
(A) Distant site.--Subject to paragraph (8),
the term``distant site'' means the site at
which the physician or practitioner is located
at the time the service is provided via a
telecommunications system.
(B) Eligible telehealth individual.--The term
``eligible telehealth individual'' means an
individual enrolled under this part who
receives a telehealth service furnished at an
originating site.
(C) Originating site.--
(i) In general.--Except as provided
in clause (iii) and paragraphs (5),
(6), and (7), the term``originating
site'' means only those sites described
in clause (ii) at which the eligible
telehealth individual is located at the
time the service is furnished via a
telecommunications system and only if
such site is located--
(I) in an area that is
designated as a rural health
professional shortage area
under section 332(a)(1)(A) of
the Public Health Service Act
(42 U.S.C. 254e(a)(1)(A));
(II) in a county that is not
included in a Metropolitan
Statistical Area; or
(III) from an entity that
participates in a Federal
telemedicine demonstration
project that has been approved
by (or receives funding from)
the Secretary of Health and
Human Services as of December
31, 2000.
(ii) Sites described.--The sites
referred to in clause (i) are the
following sites:
(I) The office of a physician
or practitioner.
(II) A critical access
hospital (as defined in section
1861(mm)(1)).
(III) A rural health clinic
(as defined in section
1861(aa)(2)).
(IV) A Federally qualified
health center (as defined in
section 1861(aa)(4)).
(V) A hospital (as defined in
section 1861(e)).
(VI) A hospital-based or
critical access hospital-based
renal dialysis center
(including satellites).
(VII) A skilled nursing
facility (as defined in section
1819(a)).
(VIII) A community mental
health center (as defined in
section 1861(ff)(3)(B)).
(IX) A renal dialysis
facility, but only for purposes
of section 1881(b)(3)(B).
(X) The home of an
individual, but only for
purposes of section
1881(b)(3)(B) or telehealth
services described in paragraph
(7).
(XI) A rural emergency
hospital (as defined in section
1861(kkk)(2)).
(iii) Expanding access to telehealth
services.--With respect to telehealth
services identified in subparagraph
(F)(i) as of the date of the enactment
of this clause that are furnished
during the 151-day period beginning on
the first day after the end of the
emergency period described in section
1135(g)(1)(B), the term ``originating
site'' means any site in the United
States at which the eligible telehealth
individual is located at the time the
service is furnished via a
telecommunications system, including
the home of an individual.
(D) Physician.--The term ``physician'' has
the meaning given that term in section 1861(r).
(E) Practitioner.--The term ``practitioner''
has the meaning given that term in section
1842(b)(18)(C) and, for the 151-day period
beginning on the first day after the end of the
period at the end of the emergency sentence
described in section 1135(g)(1)(B), shall
include a qualified occupational therapist (as
such term is used in section 1861(g)), a
qualified physical therapist (as such term is
used in section 1861(p)), a qualified speech-
language pathologist (as defined in section
1861(ll)(4)(A)), and a qualified audiologist
(as defined in section 1861(ll)(4)(B)).
(F) Telehealth service.--
(i) In general.--Subject to paragraph
(8), the term``telehealth service''
means professional consultations,
office visits, and office psychiatry
services (identified as of July 1,
2000, by HCPCS codes 99241-99275,
99201-99215, 90804-90809, and 90862
(and as subsequently modified by the
Secretary)), and any additional service
specified by the Secretary.
(ii) Yearly update.--The Secretary
shall establish a process that
provides, on an annual basis, for the
addition or deletion of services (and
HCPCS codes), as appropriate, to those
specified in clause (i) for authorized
payment under paragraph (1).
(5) Treatment of home dialysis monthly esrd-related
visit.--The geographic requirements described in
paragraph (4)(C)(i) shall not apply with respect to
telehealth services furnished on or after January 1,
2019, for purposes of section 1881(b)(3)(B), at an
originating site described in subclause (VI), (IX), or
(X) of paragraph (4)(C)(ii).
(6) Treatment of stroke telehealth services.--
(A) Non-application of originating site
requirements.--The requirements described in
paragraph (4)(C) shall not apply with respect
to telehealth services furnished on or after
January 1, 2019, for purposes of diagnosis,
evaluation, or treatment of symptoms of an
acute stroke, as determined by the Secretary.
(B) Inclusion of certain sites.--With respect
to telehealth services described in
subparagraph (A), the term ``originating site''
shall include any hospital (as defined in
section 1861(e)) or critical access hospital
(as defined in section 1861(mm)(1)), any mobile
stroke unit (as defined by the Secretary), or
any other site determined appropriate by the
Secretary, at which the eligible telehealth
individual is located at the time the service
is furnished via a telecommunications system.
(C) No originating site facility fee for new
sites.--No facility fee shall be paid under
paragraph (2)(B) to an originating site with
respect to a telehealth service described in
subparagraph (A) if the originating site does
not otherwise meet the requirements for an
originating site under paragraph (4)(C).
(7) Treatment of substance use disorder services and
mental health services furnished through telehealth.--
(A) In general.--The geographic requirements
described in paragraph (4)(C)(i) shall not
apply with respect to telehealth services
furnished on or after July 1, 2019, to an
eligible telehealth individual with a substance
use disorder diagnosis for purposes of
treatment of such disorder or co-occurring
mental health disorder, as determined by the
Secretary, or, on or after the first day after
the end of the emergency period described in
section 1135(g)(1)(B), subject to subparagraph
(B), to an eligible telehealth individual for
purposes of diagnosis, evaluation, or treatment
of a mental health disorder, as determined by
the Secretary, at an originating site described
in paragraph (4)(C)(ii) (other than an
originating site described in subclause (IX) of
such paragraph) or, for the period for which
clause (iii) of paragraph (4)(C) applies, at
any site described in such clause.
(B) Requirements for mental health services
furnished through telehealth.--
(i) In general.--Payment may not be
made under this paragraph for
telehealth services furnished on or
after the day that is the 152nd day
after the end of the period at the end
of the emergency sentence described in
section 1135(g)(1)(B)) by a physician
or practitioner to an eligible
telehealth individual for purposes of
diagnosis, evaluation, or treatment of
a mental health disorder unless such
physician or practitioner furnishes an
item or service in person, without the
use of telehealth, for which payment is
made under this title (or would have
been made under this title if such
individual were entitled to, or
enrolled for, benefits under this title
at the time such item or service is
furnished)--
(I) within the 6-month period
prior to the first time such
physician or practitioner
furnishes such a telehealth
service to the eligible
telehealth individual; and
(II) during subsequent
periods in which such physician
or practitioner furnishes such
telehealth services to the
eligible telehealth individual,
at such times as the Secretary
determines appropriate.
(ii) Clarification.--This
subparagraph shall not apply if payment
would otherwise be allowed--
(I) under this paragraph
(with respect to telehealth
services furnished to an
eligible telehealth individual
with a substance use disorder
diagnosis for purposes of
treatment of such disorder or
co-occurring mental health
disorder); or
(II) under this subsection
without application of this
paragraph.
(8) Enhancing telehealth services for federally
qualified health centers and rural health clinics.--
(A) In general.--During the emergency period
described in section 1135(g)(1)(B) and, during
the 151-day period beginning on the first day
after the end of such emergency period--
(i) the Secretary shall pay for
telehealth services that are furnished
via a telecommunications system by a
Federally qualified health center or a
rural health clinic to an eligible
telehealth individual enrolled under
this part notwithstanding that the
Federally qualified health center or
rural clinic providing the telehealth
service is not at the same location as
the beneficiary;
(ii) the amount of payment to a
Federally qualified health center or
rural health clinic that serves as a
distant site for such a telehealth
service shall be determined under
subparagraph (B); and
(iii) for purposes of this
subsection--
(I) the term ``distant site''
includes a Federally qualified
health center or rural health
clinic that furnishes a
telehealth service to an
eligible telehealth individual;
and
(II) the term ``telehealth
services'' includes a rural
health clinic service or
Federally qualified health
center service that is
furnished using telehealth to
the extent that payment codes
corresponding to services
identified by the Secretary
under clause (i) or (ii) of
paragraph (4)(F) are listed on
the corresponding claim for
such rural health clinic
service or Federally qualified
health center service.
(B) Special payment rule.--
(i) In general.--The Secretary shall
develop and implement payment methods
that apply under this subsection to a
Federally qualified health center or
rural health clinic that serves as a
distant site that furnishes a
telehealth service to an eligible
telehealth individual during the
periods for which subparagraph (A)
applies. Such payment methods shall be
based on payment rates that are similar
to the national average payment rates
for comparable telehealth services
under the physician fee schedule under
section 1848. Notwithstanding any other
provision of law, the Secretary may
implement such payment methods through
program instruction or otherwise.
(ii) Exclusion from fqhc pps
calculation and rhc air calculation.--
Costs associated with telehealth
services shall not be used to determine
the amount of payment for Federally
qualified health center services under
the prospective payment system under
section 1834(o) or for rural health
clinic services under the methodology
for all-inclusive rates (established by
the Secretary) under section
1833(a)(3).
(9) Treatment of telehealth services furnished using
audio-only telecommunications technology.--The
Secretary shall continue to provide coverage and
payment under this part for telehealth services
identified in paragraph (4)(F)(i) as of the date of the
enactment of this paragraph that are furnished via an
audio-only telecommunications system during the 151-day
period beginning on the first day after the end of the
emergency period described in section 1135(g)(1)(B).
For purposes of the previous sentence, the term
``telehealth service'' means a telehealth service
identified as of the date of the enactment of this
paragraph by a HCPCS code (and any succeeding codes)
for which the Secretary has not applied the
requirements of paragraph (1) and the first sentence of
section 410.78(a)(3) of title 42, Code of Federal
Regulations, during such emergency period.
(n) Authority To Modify or Eliminate Coverage of Certain
Preventive Services.--Notwithstanding any other provision of
this title, effective beginning on January 1, 2010, if the
Secretary determines appropriate, the Secretary may--
(1) modify--
(A) the coverage of any preventive service
described in subparagraph (A) of section
1861(ddd)(3) to the extent that such
modification is consistent with the
recommendations of the United States Preventive
Services Task Force; and
(B) the services included in the initial
preventive physical examination described in
subparagraph (B) of such section; and
(2) provide that no payment shall be made under this
title for a preventive service described in
subparagraph (A) of such section that has not received
a grade of A, B, C, or I by such Task Force.
(o) Development and Implementation of Prospective Payment
System.--
(1) Development.--
(A) In general.--The Secretary shall develop
a prospective payment system for payment for
Federally qualified health center services
furnished by Federally qualified health centers
under this title. Such system shall include a
process for appropriately describing the
services furnished by Federally qualified
health centers and shall establish payment
rates for specific payment codes based on such
appropriate descriptions of services. Such
system shall be established to take into
account the type, intensity, and duration of
services furnished by Federally qualified
health centers. Such system may include
adjustments, including geographic adjustments,
determined appropriate by the Secretary.
(B) Collection of data and evaluation.--By
not later than January 1, 2011, the Secretary
shall require Federally qualified health
centers to submit to the Secretary such
information as the Secretary may require in
order to develop and implement the prospective
payment system under this subsection, including
the reporting of services using HCPCS codes.
(2) Implementation.--
(A) In general.--Notwithstanding section
1833(a)(3)(A), the Secretary shall provide, for
cost reporting periods beginning on or after
October 1, 2014, for payments of prospective
payment rates for Federally qualified health
center services furnished by Federally
qualified health centers under this title in
accordance with the prospective payment system
developed by the Secretary under paragraph (1).
(B) Payments.--
(i) Initial payments.--The Secretary
shall implement such prospective
payment system so that the estimated
aggregate amount of prospective payment
rates (determined prior to the
application of section 1833(a)(1)(Z))
under this title for Federally
qualified health center services in the
first year that such system is
implemented is equal to 100 percent of
the estimated amount of reasonable
costs (determined without the
application of a per visit payment
limit or productivity screen and prior
to the application of section
1866(a)(2)(A)(ii)) that would have
occurred for such services under this
title in such year if the system had
not been implemented.
(ii) Payments in subsequent years.--
Payment rates in years after the year
of implementation of such system shall
be the payment rates in the previous
year increased--
(I) in the first year after
implementation of such system,
by the percentage increase in
the MEI (as defined in section
1842(i)(3)) for the year
involved; and
(II) in subsequent years, by
the percentage increase in a
market basket of Federally
qualified health center goods
and services as promulgated
through regulations, or if such
an index is not available, by
the percentage increase in the
MEI (as defined in section
1842(i)(3)) for the year
involved.
(C) Preparation for pps implementation.--
Notwithstanding any other provision of law, the
Secretary may establish and implement by
program instruction or otherwise the payment
codes to be used under the prospective payment
system under this section.
(3) Additional payments for certain fqhcs with
physicians or other practitioners receiving data 2000
waivers.--
(A) In general.--In the case of a Federally
qualified health center with respect to which,
beginning on or after January 1, 2019,
Federally qualified health center services (as
defined in section 1861(aa)(3)) are furnished
for the treatment of opioid use disorder by a
physician or practitioner who meets the
requirements described in subparagraph (C), the
Secretary shall, subject to availability of
funds under subparagraph (D), make a payment
(at such time and in such manner as specified
by the Secretary) to such Federally qualified
health center after receiving and approving an
application submitted by such Federally
qualified health center under subparagraph (B).
Such a payment shall be in an amount determined
by the Secretary, based on an estimate of the
average costs of training for purposes of
receiving a waiver described in subparagraph
(C)(ii). Such a payment may be made only one
time with respect to each such physician or
practitioner.
(B) Application.--In order to receive a
payment described in subparagraph (A), a
Federally qualified health center shall submit
to the Secretary an application for such a
payment at such time, in such manner, and
containing such information as specified by the
Secretary. A Federally qualified health center
may apply for such a payment for each physician
or practitioner described in subparagraph (A)
furnishing services described in such
subparagraph at such center.
(C) Requirements.--For purposes of
subparagraph (A), the requirements described in
this subparagraph, with respect to a physician
or practitioner, are the following:
(i) The physician or practitioner is
employed by or working under contract
with a Federally qualified health
center described in subparagraph (A)
that submits an application under
subparagraph (B).
(ii) The physician or practitioner
[first receives a waiver under section
303(g) of the Controlled Substances Act
on or after January 1, 2019] first
begins prescribing narcotic drugs in
schedule III, IV, or V of section 202
of the Controlled Substances Act for
the purpose of maintenance or
detoxification treatment on or after
January 1, 2021.
(D) Funding.--For purposes of making payments
under this paragraph, there are appropriated,
out of amounts in the Treasury not otherwise
appropriated, $6,000,000, which shall remain
available until expended.
(4) Payment for certain services furnished by
federally qualified health centers to hospice
patients.--
(A) Attending physician services for hospice
patients.--In the case of services described in
section?1812(d)(2)(A)(ii) furnished on or after
January 1, 2022, by an attending physician (as
defined in section 1861(dd)(3)(B), other than a
physician or practitioner who is employed by a
hospice program) who is employed by or working
under contract with a Federally qualified
health center, a Federally qualified health
center shall be paid for such services under
the prospective payment system under this
subsection.
(B) Mental health visits furnished via
telecommunications technology.--In the case of
mental health visits furnished via interactive,
real-time, audio and video telecommunications
technology or audio-only interactions, the in-
person mental health visit requirements
established under section 405.2463(b)(3) of
title 42 of the Code of Federal Regulations (or
a successor regulation) shall not apply prior
to the day that is the 152nd day after the end
of the emergency period described in section
1135(g)(1)(B)).
(p) Quality Incentives To Promote Patient Safety and Public
Health in Computed Tomography.--
(1) Quality incentives.--In the case of an applicable
computed tomography service (as defined in paragraph
(2)) for which payment is made under an applicable
payment system (as defined in paragraph (3)) and that
is furnished on or after January 1, 2016, using
equipment that is not consistent with the CT equipment
standard (described in paragraph (4)), the payment
amount for such service shall be reduced by the
applicable percentage (as defined in paragraph (5)).
(2) Applicable computed tomography services
defined.--In this subsection, the term ``applicable
computed tomography service'' means a service billed
using diagnostic radiological imaging codes for
computed tomography (identified as of January 1, 2014,
by HCPCS codes 70450-70498, 71250-71275, 72125-72133,
72191-72194, 73200-73206, 73700-73706, 74150-74178,
74261-74263, and 75571-75574 (and any succeeding
codes).
(3) Applicable payment system defined.--In this
subsection, the term ``applicable payment system''
means the following:
(A) The technical component and the technical
component of the global fee under the fee
schedule established under section 1848(b).
(B) The prospective payment system for
hospital outpatient department services under
section 1833(t).
(4) Consistency with ct equipment standard.--In this
subsection, the term ``not consistent with the CT
equipment standard'' means, with respect to an
applicable computed tomography service, that the
service was furnished using equipment that does not
meet each of the attributes of the National Electrical
Manufacturers Association (NEMA) Standard XR-29-2013,
entitled ``Standard Attributes on CT Equipment Related
to Dose Optimization and Management''. Through
rulemaking, the Secretary may apply successor
standards.
(5) Applicable percentage defined.--In this
subsection, the term ``applicable percentage'' means--
(A) for 2016, 5 percent; and
(B) for 2017 and subsequent years, 15
percent.
(6) Implementation.--
(A) Information.--The Secretary shall require
that information be provided and attested to by
a supplier and a hospital outpatient department
that indicates whether an applicable computed
tomography service was furnished that was not
consistent with the CT equipment standard
(described in paragraph (4)). Such information
may be included on a claim and may be a
modifier. Such information shall be verified,
as appropriate, as part of the periodic
accreditation of suppliers under section
1834(e) and hospitals under section 1865(a).
(B) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to
information described in subparagraph (A).
(q) Recognizing Appropriate Use Criteria for Certain Imaging
Services.--
(1) Program established.--
(A) In general.--The Secretary shall
establish a program to promote the use of
appropriate use criteria (as defined in
subparagraph (B)) for applicable imaging
services (as defined in subparagraph (C))
furnished in an applicable setting (as defined
in subparagraph (D)) by ordering professionals
and furnishing professionals (as defined in
subparagraphs (E) and (F), respectively).
(B) Appropriate use criteria defined.--In
this subsection, the term ``appropriate use
criteria'' means criteria, only developed or
endorsed by national professional medical
specialty societies or other provider-led
entities, to assist ordering professionals and
furnishing professionals in making the most
appropriate treatment decision for a specific
clinical condition for an individual. To the
extent feasible, such criteria shall be
evidence-based.
(C) Applicable imaging service defined.--In
this subsection, the term ``applicable imaging
service'' means an advanced diagnostic imaging
service (as defined in subsection (e)(1)(B))
for which the Secretary determines--
(i) one or more applicable
appropriate use criteria specified
under paragraph (2) apply;
(ii) there are one or more qualified
clinical decision support mechanisms
listed under paragraph (3)(C); and
(iii) one or more of such mechanisms
is available free of charge.
(D) Applicable setting defined.--In this
subsection, the term ``applicable setting''
means a physician's office, a hospital
outpatient department (including an emergency
department), an ambulatory surgical center, and
any other provider-led outpatient setting
determined appropriate by the Secretary.
(E) Ordering professional defined.--In this
subsection, the term ``ordering professional''
means a physician (as defined in section
1861(r)) or a practitioner described in section
1842(b)(18)(C) who orders an applicable imaging
service.
(F) Furnishing professional defined.--In this
subsection, the term ``furnishing
professional'' means a physician (as defined in
section 1861(r)) or a practitioner described in
section 1842(b)(18)(C) who furnishes an
applicable imaging service.
(2) Establishment of applicable appropriate use
criteria.--
(A) In general.--Not later than November 15,
2015, the Secretary shall through rulemaking,
and in consultation with physicians,
practitioners, and other stakeholders, specify
applicable appropriate use criteria for
applicable imaging services only from among
appropriate use criteria developed or endorsed
by national professional medical specialty
societies or other provider-led entities.
(B) Considerations.--In specifying applicable
appropriate use criteria under subparagraph
(A), the Secretary shall take into account
whether the criteria--
(i) have stakeholder consensus;
(ii) are scientifically valid and
evidence based; and
(iii) are based on studies that are
published and reviewable by
stakeholders.
(C) Revisions.--The Secretary shall review,
on an annual basis, the specified applicable
appropriate use criteria to determine if there
is a need to update or revise (as appropriate)
such specification of applicable appropriate
use criteria and make such updates or revisions
through rulemaking.
(D) Treatment of multiple applicable
appropriate use criteria.--In the case where
the Secretary determines that more than one
appropriate use criterion applies with respect
to an applicable imaging service, the Secretary
shall apply one or more applicable appropriate
use criteria under this paragraph for the
service.
(3) Mechanisms for consultation with applicable
appropriate use criteria.--
(A) Identification of mechanisms to consult
with applicable appropriate use criteria.--
(i) In general.--The Secretary shall
specify qualified clinical decision
support mechanisms that could be used
by ordering professionals to consult
with applicable appropriate use
criteria for applicable imaging
services.
(ii) Consultation.--The Secretary
shall consult with physicians,
practitioners, health care technology
experts, and other stakeholders in
specifying mechanisms under this
paragraph.
(iii) Inclusion of certain
mechanisms.--Mechanisms specified under
this paragraph may include any or all
of the following that meet the
requirements described in subparagraph
(B)(ii):
(I) Use of clinical decision
support modules in certified
EHR technology (as defined in
section 1848(o)(4)).
(II) Use of private sector
clinical decision support
mechanisms that are independent
from certified EHR technology,
which may include use of
clinical decision support
mechanisms available from
medical specialty
organizations.
(III) Use of a clinical
decision support mechanism
established by the Secretary.
(B) Qualified clinical decision support
mechanisms.--
(i) In general.--For purposes of this
subsection, a qualified clinical
decision support mechanism is a
mechanism that the Secretary determines
meets the requirements described in
clause (ii).
(ii) Requirements.--The requirements
described in this clause are the
following:
(I) The mechanism makes
available to the ordering
professional applicable
appropriate use criteria
specified under paragraph (2)
and the supporting
documentation for the
applicable imaging service
ordered.
(II) In the case where there
is more than one applicable
appropriate use criterion
specified under such paragraph
for an applicable imaging
service, the mechanism
indicates the criteria that it
uses for the service.
(III) The mechanism
determines the extent to which
an applicable imaging service
ordered is consistent with the
applicable appropriate use
criteria so specified.
(IV) The mechanism generates
and provides to the ordering
professional a certification or
documentation that documents
that the qualified clinical
decision support mechanism was
consulted by the ordering
professional.
(V) The mechanism is updated
on a timely basis to reflect
revisions to the specification
of applicable appropriate use
criteria under such paragraph.
(VI) The mechanism meets
privacy and security standards
under applicable provisions of
law.
(VII) The mechanism performs
such other functions as
specified by the Secretary,
which may include a requirement
to provide aggregate feedback
to the ordering professional.
(C) List of mechanisms for consultation with
applicable appropriate use criteria.--
(i) Initial list.--Not later than
April 1, 2016, the Secretary shall
publish a list of mechanisms specified
under this paragraph.
(ii) Periodic updating of list.--The
Secretary shall identify on an annual
basis the list of qualified clinical
decision support mechanisms specified
under this paragraph.
(4) Consultation with applicable appropriate use
criteria.--
(A) Consultation by ordering professional.--
Beginning with January 1, 2017, subject to
subparagraph (C), with respect to an applicable
imaging service ordered by an ordering
professional that would be furnished in an
applicable setting and paid for under an
applicable payment system (as defined in
subparagraph (D)), an ordering professional
shall--
(i) consult with a qualified decision
support mechanism listed under
paragraph (3)(C); and
(ii) provide to the furnishing
professional the information described
in clauses (i) through (iii) of
subparagraph (B).
(B) Reporting by furnishing professional.--
Beginning with January 1, 2017, subject to
subparagraph (C), with respect to an applicable
imaging service furnished in an applicable
setting and paid for under an applicable
payment system (as defined in subparagraph
(D)), payment for such service may only be made
if the claim for the service includes the
following:
(i) Information about which qualified
clinical decision support mechanism was
consulted by the ordering professional
for the service.
(ii) Information regarding--
(I) whether the service
ordered would adhere to the
applicable appropriate use
criteria specified under
paragraph (2);
(II) whether the service
ordered would not adhere to
such criteria; or
(III) whether such criteria
was not applicable to the
service ordered.
(iii) The national provider
identifier of the ordering professional
(if different from the furnishing
professional).
(C) Exceptions.--The provisions of
subparagraphs (A) and (B) and paragraph (6)(A)
shall not apply to the following:
(i) Emergency services.--An
applicable imaging service ordered for
an individual with an emergency medical
condition (as defined in section
1867(e)(1)).
(ii) Inpatient services.--An
applicable imaging service ordered for
an inpatient and for which payment is
made under part A.
(iii) Significant hardship.--An
applicable imaging service ordered by
an ordering professional who the
Secretary may, on a case-by-case basis,
exempt from the application of such
provisions if the Secretary determines,
subject to annual renewal, that
consultation with applicable
appropriate use criteria would result
in a significant hardship, such as in
the case of a professional who
practices in a rural area without
sufficient Internet access.
(D) Applicable payment system defined.--In
this subsection, the term ``applicable payment
system'' means the following:
(i) The physician fee schedule
established under section 1848(b).
(ii) The prospective payment system
for hospital outpatient department
services under section 1833(t).
(iii) The ambulatory surgical center
payment systems under section 1833(i).
(5) Identification of outlier ordering
professionals.--
(A) In general.--With respect to applicable
imaging services furnished beginning with 2017,
the Secretary shall determine, on an annual
basis, no more than five percent of the total
number of ordering professionals who are
outlier ordering professionals.
(B) Outlier ordering professionals.--The
determination of an outlier ordering
professional shall--
(i) be based on low adherence to
applicable appropriate use criteria
specified under paragraph (2), which
may be based on comparison to other
ordering professionals; and
(ii) include data for ordering
professionals for whom prior
authorization under paragraph (6)(A)
applies.
(C) Use of two years of data.--The Secretary
shall use two years of data to identify outlier
ordering professionals under this paragraph.
(D) Process.--The Secretary shall establish a
process for determining when an outlier
ordering professional is no longer an outlier
ordering professional.
(E) Consultation with stakeholders.--The
Secretary shall consult with physicians,
practitioners and other stakeholders in
developing methods to identify outlier ordering
professionals under this paragraph.
(6) Prior authorization for ordering professionals
who are outliers.--
(A) In general.--Beginning January 1, 2020,
subject to paragraph (4)(C), with respect to
services furnished during a year, the Secretary
shall, for a period determined appropriate by
the Secretary, apply prior authorization for
applicable imaging services that are ordered by
an outlier ordering professional identified
under paragraph (5).
(B) Appropriate use criteria in prior
authorization.--In applying prior authorization
under subparagraph (A), the Secretary shall
utilize only the applicable appropriate use
criteria specified under this subsection.
(C) Funding.--For purposes of carrying out
this paragraph, the Secretary shall provide for
the transfer, from the Federal Supplementary
Medical Insurance Trust Fund under section
1841, of $5,000,000 to the Centers for Medicare
& Medicaid Services Program Management Account
for each of fiscal years 2019 through 2021.
Amounts transferred under the preceding
sentence shall remain available until expended.
(7) Construction.--Nothing in this subsection shall
be construed as granting the Secretary the authority to
develop or initiate the development of clinical
practice guidelines or appropriate use criteria.
(r) Payment for Renal Dialysis Services for Individuals With
Acute Kidney Injury.--
(1) Payment rate.--In the case of renal dialysis
services (as defined in subparagraph (B) of section
1881(b)(14)) furnished under this part by a renal
dialysis facility or provider of services paid under
such section during a year (beginning with 2017) to an
individual with acute kidney injury (as defined in
paragraph (2)), the amount of payment under this part
for such services shall be the base rate for renal
dialysis services determined for such year under such
section, as adjusted by any applicable geographic
adjustment factor applied under subparagraph
(D)(iv)(II) of such section and may be adjusted by the
Secretary (on a budget neutral basis for payments under
this paragraph) by any other adjustment factor under
subparagraph (D) of such section.
(2) Individual with acute kidney injury defined.--In
this subsection, the term ``individual with acute
kidney injury'' means an individual who has acute loss
of renal function and does not receive renal dialysis
services for which payment is made under section
1881(b)(14).
(s) Payment for Applicable Disposable Devices.--
(1) Separate payment.--The Secretary shall make a
payment (separate from the payments otherwise made
under section 1895) in the amount established under
paragraph (3) to a home health agency for an applicable
disposable device (as defined in paragraph (2)) when
furnished on or after January 1, 2017, to an individual
who receives home health services for which payment is
made under section 1895(b).
(2) Applicable disposable device.--In this
subsection, the term applicable disposable device means
a disposable device that, as determined by the
Secretary, is--
(A) a disposable negative pressure wound
therapy device that is an integrated system
comprised of a non-manual vacuum pump, a
receptacle for collecting exudate, and
dressings for the purposes of wound therapy;
and
(B) a substitute for, and used in lieu of, a
negative pressure wound therapy durable medical
equipment item that is an integrated system of
a negative pressure vacuum pump, a separate
exudate collection canister, and dressings that
would otherwise be covered for individuals for
such wound therapy.
(3) Payment amount.--The separate payment amount
established under this paragraph for an applicable
disposable device for a year shall be equal to the
amount of the payment that would be made under section
1833(t) (relating to payment for covered OPD services)
for the year for the Level I Healthcare Common
Procedure Coding System (HCPCS) code for which the
description for a professional service includes the
furnishing of such device.
(t) Site-of-Service Price Transparency.--
(1) In general.--In order to facilitate price
transparency with respect to items and services for
which payment may be made either to a hospital
outpatient department or to an ambulatory surgical
center under this title, the Secretary shall, for 2018
and each year thereafter, make available to the public
via a searchable Internet website, with respect to an
appropriate number of such items and services--
(A) the estimated payment amount for the item
or service under the outpatient department fee
schedule under subsection (t) of section 1833
and the ambulatory surgical center payment
system under subsection (i) of such section;
and
(B) the estimated amount of beneficiary
liability applicable to the item or service.
(2) Calculation of estimated beneficiary liability.--
For purposes of paragraph (1)(B), the estimated amount
of beneficiary liability, with respect to an item or
service, is the amount for such item or service for
which an individual who does not have coverage under a
Medicare supplemental policy certified under section
1882 or any other supplemental insurance coverage is
responsible.
(3) Implementation.--In carrying out this subsection,
the Secretary--
(A) shall include in the notice described in
section 1804(a) a notification of the
availability of the estimated amounts made
available under paragraph (1); and
(B) may utilize mechanisms in existence on
the date of enactment of this subsection, such
as the portion of the Internet website of the
Centers for Medicare & Medicaid Services on
which information comparing physician
performance is posted (commonly referred to as
the Physician Compare Internet website), to
make available such estimated amounts under
such paragraph.
(4) Funding.--For purposes of implementing this
subsection, the Secretary shall provide for the
transfer, from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 to the Centers
for Medicare & Medicaid Services Program Management
Account, of $6,000,000 for fiscal year 2017, to remain
available until expended.
(u) Payment and Related Requirements for Home Infusion
Therapy.--
(1) Payment.--
(A) Single payment.--
(i) In general.--Subject to clause
(iii) and subparagraphs (B) and (C),
the Secretary shall implement a payment
system under which a single payment is
made under this title to a qualified
home infusion therapy supplier for
items and services described in
subparagraphs (A) and (B) of section
1861(iii)(2)) furnished by a qualified
home infusion therapy supplier (as
defined in section 1861(iii)(3)(D)) in
coordination with the furnishing of
home infusion drugs (as defined in
section 1861(iii)(3)(C)) under this
part.
(ii) Unit of single payment.--A unit
of single payment under the payment
system implemented under this
subparagraph is for each infusion drug
administration calendar day in the
individual's home. The Secretary shall,
as appropriate, establish single
payment amounts for types of infusion
therapy, including to take into account
variation in utilization of nursing
services by therapy type.
(iii) Limitation.--The single payment
amount determined under this
subparagraph after application of
subparagraph (B) and paragraph (3)
shall not exceed the amount determined
under the fee schedule under section
1848 for infusion therapy services
furnished in a calendar day if
furnished in a physician office
setting, except such single payment
shall not reflect more than 5 hours of
infusion for a particular therapy in a
calendar day.
(B) Required adjustments.--The Secretary
shall adjust the single payment amount
determined under subparagraph (A) for home
infusion therapy services under section
1861(iii)(1) to reflect other factors such as--
(i) a geographic wage index and other
costs that may vary by region; and
(ii) patient acuity and complexity of
drug administration.
(C) Discretionary adjustments.--
(i) In general.--Subject to clause
(ii), the Secretary may adjust the
single payment amount determined under
subparagraph (A) (after application of
subparagraph (B)) to reflect outlier
situations and other factors as the
Secretary determines appropriate.
(ii) Requirement of budget
neutrality.--Any adjustment under this
subparagraph shall be made in a budget
neutral manner.
(2) Considerations.--In developing the payment system
under this subsection, the Secretary may consider the
costs of furnishing infusion therapy in the home,
consult with home infusion therapy suppliers, consider
payment amounts for similar items and services under
this part and part A, and consider payment amounts
established by Medicare Advantage plans under part C
and in the private insurance market for home infusion
therapy (including average per treatment day payment
amounts by type of home infusion therapy).
(3) Annual updates.--
(A) In general.--Subject to subparagraph (B),
the Secretary shall update the single payment
amount under this subsection from year to year
beginning in 2022 by increasing the single
payment amount from the prior year by the
percentage increase in the Consumer Price Index
for all urban consumers (United States city
average) for the 12-month period ending with
June of the preceding year.
(B) Adjustment.--For each year, the Secretary
shall reduce the percentage increase described
in subparagraph (A) by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the
preceding sentence may result in a percentage
being less than 0.0 for a year, and may result
in payment being less than such payment rates
for the preceding year.
(4) Authority to apply prior authorization.--The
Secretary may, as determined appropriate by the
Secretary, apply prior authorization for home infusion
therapy services under section 1861(iii)(1).
(5) Accreditation of qualified home infusion therapy
suppliers.--
(A) Factors for designation of accreditation
organizations.--The Secretary shall consider
the following factors in designating
accreditation organizations under subparagraph
(B) and in reviewing and modifying the list of
accreditation organizations designated pursuant
to subparagraph (C):
(i) The ability of the organization
to conduct timely reviews of
accreditation applications.
(ii) The ability of the organization
to take into account the capacities of
suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
(iii) Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
(iv) Such other factors as the
Secretary determines appropriate.
(B) Designation.--Not later than January 1,
2021, the Secretary shall designate
organizations to accredit suppliers furnishing
home infusion therapy. The list of
accreditation organizations so designated may
be modified pursuant to subparagraph (C).
(C) Review and modification of list of
accreditation organizations.--
(i) In general.--The Secretary shall
review the list of accreditation
organizations designated under
subparagraph (B) taking into account
the factors under subparagraph (A).
Taking into account the results of such
review, the Secretary may, by
regulation, modify the list of
accreditation organizations designated
under subparagraph (B).
(ii) Special rule for accreditations
done prior to removal from list of
designated accreditation
organizations.--In the case where the
Secretary removes an organization from
the list of accreditation organizations
designated under subparagraph (B), any
supplier that is accredited by the
organization during the period
beginning on the date on which the
organization is designated as an
accreditation organization under
subparagraph (B) and ending on the date
on which the organization is removed
from such list shall be considered to
have been accredited by an organization
designated by the Secretary under
subparagraph (B) for the remaining
period such accreditation is in effect.
(D) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2021, by an
accreditation organization designated by the
Secretary under subparagraph (B) as of January
1, 2019, such supplier shall be considered to
have been accredited by an organization
designated by the Secretary under such
paragraph as of January 1, 2023, for the
remaining period such accreditation is in
effect.
(6) Notification of infusion therapy options
available prior to furnishing home infusion therapy.--
Prior to the furnishing of home infusion therapy to an
individual, the physician who establishes the plan
described in section 1861(iii)(1) for the individual
shall provide notification (in a form, manner, and
frequency determined appropriate by the Secretary) of
the options available (such as home, physician's
office, hospital outpatient department) for the
furnishing of infusion therapy under this part.
(7) Home infusion therapy services temporary
transitional payment.--
(A) Temporary transitional payment.--
(i) In general.--The Secretary shall,
in accordance with the payment
methodology described in subparagraph
(B) and subject to the provisions of
this paragraph, provide a home infusion
therapy services temporary transitional
payment under this part to an eligible
home infusion supplier (as defined in
subparagraph (F)) for items and
services described in subparagraphs (A)
and (B) of section 1861(iii)(2))
furnished during the period specified
in clause (ii) by such supplier in
coordination with the furnishing of
transitional home infusion drugs (as
defined in clause (iii)).
(ii) Period specified.--For purposes
of clause (i), the period specified in
this clause is the period beginning on
January 1, 2019, and ending on the day
before the date of the implementation
of the payment system under paragraph
(1)(A).
(iii) Transitional home infusion drug
defined.--For purposes of this
paragraph, the term ``transitional home
infusion drug'' has the meaning given
to the term ``home infusion drug''
under section 1861(iii)(3)(C)), except
that clause (ii) of such section shall
not apply if a drug described in such
clause is identified in clauses (i),
(ii), (iii) or (iv) of subparagraph (C)
as of the date of the enactment of this
paragraph.
(B) Payment methodology.--For purposes of
this paragraph, the Secretary shall establish a
payment methodology, with respect to items and
services described in subparagraph (A)(i).
Under such payment methodology the Secretary
shall--
(i) create the three payment
categories described in clauses (i),
(ii), and (iii) of subparagraph (C);
(ii) assign drugs to such categories,
in accordance with such clauses;
(iii) assign appropriate Healthcare
Common Procedure Coding System (HCPCS)
codes to each payment category; and
(iv) establish a single payment
amount for each such payment category,
in accordance with subparagraph (D),
for each infusion drug administration
calendar day in the individual's home
for drugs assigned to such category.
(C) Payment categories.--
(i) Payment category 1.--The
Secretary shall create a payment
category 1 and assign to such category
drugs which are covered under the Local
Coverage Determination on External
Infusion Pumps (LCD number L33794) and
billed with the following HCPCS codes
(as identified as of January 1, 2018,
and as subsequently modified by the
Secretary): J0133, J0285, J0287, J0288,
J0289, J0895, J1170, J1250, J1265,
J1325, J1455, J1457, J1570, J2175,
J2260, J2270, J2274, J2278, J3010, or
J3285.
(ii) Payment category 2.--The
Secretary shall create a payment
category 2 and assign to such category
drugs which are covered under such
local coverage determination and billed
with the following HCPCS codes (as
identified as of January 1, 2018, and
as subsequently modified by the
Secretary): J1555 JB, J1559 JB, J1561
JB, J1562 JB, J1569 JB, or J1575 JB.
(iii) Payment category 3.--The
Secretary shall create a payment
category 3 and assign to such category
drugs which are covered under such
local coverage determination and billed
with the following HCPCS codes (as
identified as of January 1, 2018, and
as subsequently modified by the
Secretary): J9000, J9039, J9040, J9065,
J9100, J9190, J9200, J9360, or J9370.
(iv) Infusion drugs not otherwise
included.--With respect to drugs that
are not included in payment category 1,
2, or 3 under clause (i), (ii), or
(iii), respectively, the Secretary
shall assign to the most appropriate of
such categories, as determined by the
Secretary, drugs which are--
(I) covered under such local
coverage determination and
billed under HCPCS codes J7799
or J7999 (as identified as of
July 1, 2017, and as
subsequently modified by the
Secretary); or
(II) billed under any code
that is implemented after the
date of the enactment of this
paragraph and included in such
local coverage determination or
included in subregulatory
guidance as a home infusion
drug described in subparagraph
(A)(i).
(D) Payment amounts.--
(i) In general.--Under the payment
methodology, the Secretary shall pay
eligible home infusion suppliers, with
respect to items and services described
in subparagraph (A)(i) furnished during
the period described in subparagraph
(A)(ii) by such supplier to an
individual, at amounts equal to the
amounts determined under the physician
fee schedule established under section
1848 for services furnished during the
year for codes and units of such codes
described in clauses (ii), (iii), and
(iv) with respect to drugs included in
the payment category under subparagraph
(C) specified in the respective clause,
determined without application of the
geographic adjustment under subsection
(e) of such section.
(ii) Payment amount for category 1.--
For purposes of clause (i), the codes
and units described in this clause,
with respect to drugs included in
payment category 1 described in
subparagraph (C)(i), are one unit of
HCPCS code 96365 plus three units of
HCPCS code 96366 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(iii) Payment amount for category
2.--For purposes of clause (i), the
codes and units described in this
clause, with respect to drugs included
in payment category 2 described in
subparagraph (C)(i), are one unit of
HCPCS code 96369 plus three units of
HCPCS code 96370 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(iv) Payment amount for category 3.--
For purposes of clause (i), the codes
and units described in this clause,
with respect to drugs included in
payment category 3 described in
subparagraph (C)(i), are one unit of
HCPCS code 96413 plus three units of
HCPCS code 96415 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(E) Clarifications.--
(i) Infusion drug administration
day.--For purposes of this subsection,
with respect to the furnishing of
transitional home infusion drugs or
home infusion drugs to an individual by
an eligible home infusion supplier or a
qualified home infusion therapy
supplier, a reference to payment to
such supplier for an infusion drug
administration calendar day in the
individual's home shall refer to
payment only for the date on which
professional services (as described in
section 1861(iii)(2)(A)) were furnished
to administer such drugs to such
individual. For purposes of the
previous sentence, an infusion drug
administration calendar day shall
include all such drugs administered to
such individual on such day.
(ii) Treatment of multiple drugs
administered on same infusion drug
administration day.--In the case that
an eligible home infusion supplier,
with respect to an infusion drug
administration calendar day in an
individual's home, furnishes to such
individual transitional home infusion
drugs which are not all assigned to the
same payment category under
subparagraph (C), payment to such
supplier for such infusion drug
administration calendar day in the
individual's home shall be a single
payment equal to the amount of payment
under this paragraph for the drug,
among all such drugs so furnished to
such individual during such calendar
day, for which the highest payment
would be made under this paragraph.
(F) Eligible home infusion suppliers.--In
this paragraph, the term ``eligible home
infusion supplier'' means a supplier that is
enrolled under this part as a pharmacy that
provides external infusion pumps and external
infusion pump supplies and that maintains all
pharmacy licensure requirements in the State in
which the applicable infusion drugs are
administered.
(G) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(v) Payment for Outpatient Physical Therapy Services and
Outpatient Occupational Therapy Services Furnished by a Therapy
Assistant.--
(1) In general.--In the case of an outpatient
physical therapy service or outpatient occupational
therapy service furnished on or after January 1, 2022,
for which payment is made under section 1848 or
subsection (k), that is furnished in whole or in part
by a therapy assistant (as defined by the Secretary),
the amount of payment for such service shall be an
amount equal to 85 percent of the amount of payment
otherwise applicable for the service under this part.
Nothing in the preceding sentence shall be construed to
change applicable requirements with respect to such
services.
(2) Use of modifier.--
(A) Establishment.--Not later than January 1,
2019, the Secretary shall establish a modifier
to indicate (in a form and manner specified by
the Secretary), in the case of an outpatient
physical therapy service or outpatient
occupational therapy service furnished in whole
or in part by a therapy assistant (as so
defined), that the service was furnished by a
therapy assistant.
(B) Required use.--Each request for payment,
or bill submitted, for an outpatient physical
therapy service or outpatient occupational
therapy service furnished in whole or in part
by a therapy assistant (as so defined) on or
after January 1, 2020, shall include the
modifier established under subparagraph (A) for
each such service.
(3) Implementation.--The Secretary shall implement
this subsection through notice and comment rulemaking.
(w) Opioid Use Disorder Treatment Services.--
(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of
section 1861(jjj)) an amount that is equal to 100
percent of a bundled payment under this part for opioid
use disorder treatment services (as defined in
paragraph (1) of such section) that are furnished by
such program to an individual during an episode of care
(as defined by the Secretary) beginning on or after
January 1, 2020. The Secretary shall ensure, as
determined appropriate by the Secretary, that no
duplicative payments are made under this part or part D
for items and services furnished by an opioid treatment
program.
(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the
type of medication provided (such as buprenorphine,
methadone, naltrexone, or a new innovative drug), the
frequency of services, the scope of services furnished,
characteristics of the individuals furnished such
services, or other factors as the Secretary determine
appropriate. In developing such bundles, the Secretary
may consider payment rates paid to opioid treatment
programs for comparable services under State plans
under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
(3) Annual updates.--The Secretary shall provide an
update each year to the bundled payment amounts under
this subsection.
(x) Payment Rules Relating to Rural Emergency Hospitals.--
(1) Payment for rural emergency hospital services.--
In the case of rural emergency hospital services (as
defined in section 1861(kkk)(1)), furnished by a rural
emergency hospital (as defined in section 1861(kkk)(2))
on or after January 1, 2023, the amount of payment for
such services shall be equal to the amount of payment
that would otherwise apply under section 1833(t) for
covered OPD services (as defined in section
1833(t)(1)(B) (other than clause (ii) of such
section)), increased by 5 percent to reflect the higher
costs incurred by such hospitals, and shall include the
application of any copayment amount determined under
section 1833(t)(8) as if such increase had not
occurred.
(2) Additional facility payment.--
(A) In general.--The Secretary shall make
monthly payments to a rural emergency hospital
in an amount that is equal to \1/12\ of the
annual additional facility payment specified in
subparagraph (B).
(B) Annual additional facility payment
amount.--The annual additional facility payment
amount specified in this subparagraph is--
(i) for 2023, a Medicare subsidy
amount determined under subparagraph
(C); and
(ii) for 2024 and each subsequent
year, the amount determined under this
subparagraph for the preceding year,
increased by the hospital market basket
percentage increase.
(C) Determination of medicare subsidy
amount.--For purposes of subparagraph (B)(i),
the Medicare subsidy amount determined under
this subparagraph is an amount equal to--
(i) the excess (if any) of--
(I) the total amount that the
Secretary determines was paid
under this title to all
critical access hospitals in
2019; over
(II) the estimated total
amount that the Secretary
determines would have been paid
under this title to such
hospitals in 2019 if payment
were made for inpatient
hospital, outpatient hospital,
and skilled nursing facility
services under the applicable
prospective payment systems for
such services during such year;
divided by
(ii) the total number of such
hospitals in 2019.
(D) Reporting on use of the additional
facility payment.--A rural emergency hospital
receiving the additional facility payment under
this paragraph shall maintain detailed
information as specified by the Secretary as to
how the facility has used the additional
facility payments. Such information shall be
made available to the Secretary upon request.
(3) Payment for ambulance services.--For provisions
relating to payment for ambulance services furnished by
an entity owned and operated by a rural emergency
hospital, see section 1834(l).
(4) Payment for post-hospital extended care
services.--For provisions relating to payment for post-
hospital extended care services furnished by a rural
emergency hospital that has a unit that is a distinct
part licensed as a skilled nursing facility, see
section 1888(e).
(5) Source of payments.--
(A) In general.--Except as provided in
subparagraph (B), payments under this
subsection shall be made from the Federal
Supplementary Medical Insurance Trust Fund
under section 1841.
(B) Additional facility payment and post-
hospital extended care services.--Payments
under paragraph (2) shall be made from the
Federal Hospital Insurance Trust Fund under
section 1817.
(y) Payment for Certain Services Furnished by Rural Health
Clinics to Hospice Patients.--
(1) Attending physician services for hospice
patients.--In the case of services described in section
1812(d)(2)(A)(ii) furnished on or after January 1,
2022, by an attending physician (as defined in section
1861(dd)(3)(B), other than a physician or practitioner
who is employed by a hospice program) who is employed
by or working under contract with a rural health
clinic, a rural health clinic shall be paid for such
services under the methodology for all-inclusive rates
(established by the Secretary) under section
1833(a)(3), subject to the limits described in section
1833(f).
(2) Mental health visits furnished via
telecommunications technology.--In the case of mental
health visits furnished via interactive, real-time,
audio and video telecommunications technology or audio-
only interactions, the in-person mental health visit
requirements established under section 405.2463(b)(3)
of title 42 of the Code of Federal Regulations (or a
successor regulation) shall not apply prior to the day
that is the 152nd day after the end of the emergency
period described in section 1135(g)(1)(B)).
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
(a) Implementation of 4-Year Demonstration Program.--
(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration
program under this title (in this section referred to
as the ``Program'') to increase access of applicable
beneficiaries to opioid use disorder treatment
services, improve physical and mental health outcomes
for such beneficiaries, and to the extent possible,
reduce expenditures under this title. Under the
Program, the Secretary shall make payments under
subsection (e) to participants (as defined in
subsection (c)(1)(A)) for furnishing opioid use
disorder treatment services delivered through opioid
use disorder care teams, or arranging for such services
to be furnished, to applicable beneficiaries
participating in the Program.
(2) Opioid use disorder treatment services.--For
purposes of this section, the term ``opioid use
disorder treatment services''--
(A) means, with respect to an applicable
beneficiary, services that are furnished for
the treatment of opioid use disorders and that
utilize drugs approved under section 505 of the
Federal Food, Drug, and Cosmetic Act for the
treatment of opioid use disorders in an
outpatient setting; and
(B) includes--
(i) medication-assisted treatment;
(ii) treatment planning;
(iii) psychiatric, psychological, or
counseling services (or any combination
of such services), as appropriate;
(iv) social support services, as
appropriate; and
(v) care management and care
coordination services, including
coordination with other providers of
services and suppliers not on an opioid
use disorder care team.
(b) Program Design.--
(1) In general.--The Secretary shall design the
Program in such a manner to allow for the evaluation of
the extent to which the Program accomplishes the
following purposes:
(A) Reduces hospitalizations and emergency
department visits.
(B) Increases use of medication-assisted
treatment for opioid use disorders.
(C) Improves health outcomes of individuals
with opioid use disorders, including by
reducing the incidence of infectious diseases
(such as hepatitis C and HIV).
(D) Does not increase the total spending on
items and services under this title.
(E) Reduces deaths from opioid overdose.
(F) Reduces the utilization of inpatient
residential treatment.
(2) Consultation.--In designing the Program,
including the criteria under subsection (e)(2)(A), the
Secretary shall, not later than 3 months after the date
of the enactment of this section, consult with
specialists in the field of addiction, clinicians in
the primary care community, and beneficiary groups.
(c) Participants; Opioid Use Disorder Care Teams.--
(1) Participants.--
(A) Definition.--In this section, the term
``participant'' means an entity or individual--
(i) that is otherwise enrolled under
this title and that is--
(I) a physician (as defined
in section 1861(r)(1));
(II) a group practice
comprised of at least one
physician described in
subclause (I);
(III) a hospital outpatient
department;
(IV) a federally qualified
health center (as defined in
section 1861(aa)(4));
(V) a rural health clinic (as
defined in section
1861(aa)(2));
(VI) a community mental
health center (as defined in
section 1861(ff)(3)(B));
(VII) a clinic certified as a
certified community behavioral
health clinic pursuant to
section 223 of the Protecting
Access to Medicare Act of 2014;
or
(VIII) any other individual
or entity specified by the
Secretary;
(ii) that applied for and was
selected to participate in the Program
pursuant to an application and
selection process established by the
Secretary; and
(iii) that establishes an opioid use
disorder care team (as defined in
paragraph (2)) through employing or
contracting with health care
practitioners described in paragraph
(2)(A), and uses such team to furnish
or arrange for opioid use disorder
treatment services in the outpatient
setting under the Program.
(B) Preference.--In selecting participants
for the Program, the Secretary shall give
preference to individuals and entities that are
located in areas with a prevalence of opioid
use disorders that is higher than the national
average prevalence.
(2) Opioid use disorder care teams.--
(A) In general.--For purposes of this
section, the term ``opioid use disorder care
team'' means a team of health care
practitioners established by a participant
described in paragraph (1)(A) that--
(i) shall include--
(I) at least one physician
(as defined in section
1861(r)(1)) furnishing primary
care services or addiction
treatment services to an
applicable beneficiary; and
(II) at least one eligible
practitioner (as defined in
paragraph (3)), who may be a
physician who meets the
criterion in subclause (I); and
(ii) may include other practitioners
licensed under State law to furnish
psychiatric, psychological, counseling,
and social services to applicable
beneficiaries.
(B) Requirements for receipt of payment under
program.--In order to receive payments under
subsection (e), each participant in the Program
shall--
(i) furnish opioid use disorder
treatment services through opioid use
disorder care teams to applicable
beneficiaries who agree to receive the
services;
(ii) meet minimum criteria, as
established by the Secretary; and
(iii) submit to the Secretary, in
such form, manner, and frequency as
specified by the Secretary, with
respect to each applicable beneficiary
for whom opioid use disorder treatment
services are furnished by the opioid
use disorder care team, data and such
other information as the Secretary
determines appropriate to--
(I) monitor and evaluate the
Program;
(II) determine if minimum
criteria are met under clause
(ii); and
(III) determine the incentive
payment under subsection (e).
(3) Eligible practitioner defined.--For purposes of
this section, the term ``eligible practitioner'' means
a physician or other health care practitioner, such as
a nurse practitioner, that--
(A) is enrolled under section 1866(j)(1); and
(B) is authorized to prescribe or dispense
narcotic drugs to individuals for maintenance
treatment or detoxification treatment[; and].
[(C) has in effect a waiver in accordance
with section 303(g) of the Controlled
Substances Act for such purpose and is
otherwise in compliance with regulations
promulgated by the Substance Abuse and Mental
Health Services Administration to carry out
such section.]
(d) Participation of Applicable Beneficiaries.--
(1) Applicable beneficiary defined.--In this section,
the term ``applicable beneficiary'' means an individual
who--
(A) is entitled to, or enrolled for, benefits
under part A and enrolled for benefits under
part B;
(B) is not enrolled in a Medicare Advantage
plan under part C;
(C) has a current diagnosis for an opioid use
disorder; and
(D) meets such other criteria as the
Secretary determines appropriate.
Such term shall include an individual who is dually
eligible for benefits under this title and title XIX if
such individual satisfies the criteria described in
subparagraphs (A) through (D).
(2) Voluntary beneficiary participation; limitation
on number of beneficiaries.--An applicable beneficiary
may participate in the Program on a voluntary basis and
may terminate participation in the Program at any time.
Not more than 20,000 applicable beneficiaries may
participate in the Program at any time.
(3) Services.--In order to participate in the
Program, an applicable beneficiary shall agree to
receive opioid use disorder treatment services from a
participant. Participation under the Program shall not
affect coverage of or payment for any other item or
service under this title for the applicable
beneficiary.
(4) Beneficiary access to services.--Nothing in this
section shall be construed as encouraging providers to
limit applicable beneficiary access to services covered
under this title, and applicable beneficiaries shall
not be required to relinquish access to any benefit
under this title as a condition of receiving services
from a participant in the Program.
(e) Payments.--
(1) Per applicable beneficiary per month care
management fee.--
(A) In general.--The Secretary shall
establish a schedule of per applicable
beneficiary per month care management fees.
Such a per applicable beneficiary per month
care management fee shall be paid to a
participant in addition to any other amount
otherwise payable under this title to the
health care practitioners in the participant's
opioid use disorder care team or, if
applicable, to the participant. A participant
may use such per applicable beneficiary per
month care management fee to deliver additional
services to applicable beneficiaries, including
services not otherwise eligible for payment
under this title.
(B) Payment amounts.--In carrying out
subparagraph (A), the Secretary may--
(i) consider payments otherwise
payable under this title for opioid use
disorder treatment services and the
needs of applicable beneficiaries;
(ii) pay a higher per applicable
beneficiary per month care management
fee for an applicable beneficiary who
receives more intensive treatment
services from a participant and for
whom those services are appropriate
based on clinical guidelines for opioid
use disorder care;
(iii) pay a higher per applicable
beneficiary per month care management
fee for the month in which the
applicable beneficiary begins treatment
with a participant than in subsequent
months, to reflect the greater time and
costs required for the planning and
initiation of treatment, as compared to
maintenance of treatment; and
(iv) take into account whether a
participant's opioid use disorder care
team refers applicable beneficiaries to
other suppliers or providers for any
opioid use disorder treatment services.
(C) No duplicate payment.--The Secretary
shall make payments under this paragraph to
only one participant for services furnished to
an applicable beneficiary during a calendar
month.
(2) Incentive payments.--
(A) In general.--Under the Program, the
Secretary shall establish a performance-based
incentive payment, which shall be paid (using a
methodology established and at a time
determined appropriate by the Secretary) to
participants based on the performance of
participants with respect to criteria, as
determined appropriate by the Secretary, in
accordance with subparagraph (B).
(B) Criteria.--
(i) In general.--Criteria described
in subparagraph (A) may include
consideration of the following:
(I) Patient engagement and
retention in treatment.
(II) Evidence-based
medication-assisted treatment.
(III) Other criteria
established by the Secretary.
(ii) Required consultation and
consideration.--In determining criteria
described in subparagraph (A), the
Secretary shall--
(I) consult with
stakeholders, including
clinicians in the primary care
community and in the field of
addiction medicine; and
(II) consider existing
clinical guidelines for the
treatment of opioid use
disorders.
(C) No duplicate payment.--The Secretary
shall ensure that no duplicate payments under
this paragraph are made with respect to an
applicable beneficiary.
(f) Multipayer Strategy.--In carrying out the Program, the
Secretary shall encourage other payers to provide similar
payments and to use similar criteria as applied under the
Program under subsection (e)(2)(C). The Secretary may enter
into a memorandum of understanding with other payers to align
the methodology for payment provided by such a payer related to
opioid use disorder treatment services with such methodology
for payment under the Program.
(g) Evaluation.--
(1) In general.--The Secretary shall conduct an
intermediate and final evaluation of the program. Each
such evaluation shall determine the extent to which
each of the purposes described in subsection (b) have
been accomplished under the Program.
(2) Reports.--The Secretary shall submit to
Congress--
(A) a report with respect to the intermediate
evaluation under paragraph (1) not later than 3
years after the date of the implementation of
the Program; and
(B) a report with respect to the final
evaluation under paragraph (1) not later than 6
years after such date.
(h) Funding.--
(1) Administrative funding.--For the purposes of
implementing, administering, and carrying out the
Program (other than for purposes described in paragraph
(2)), $5,000,000 shall be available from the Federal
Supplementary Medical Insurance Trust Fund under
section 1841.
(2) Care management fees and incentives.--For the
purposes of making payments under subsection (e),
$10,000,000 shall be available from the Federal
Supplementary Medical Insurance Trust Fund under
section 1841 for each of fiscal years 2021 through
2024.
(3) Availability.--Amounts transferred under this
subsection for a fiscal year shall be available until
expended.
(i) Waivers.--The Secretary may waive any provision of this
title as may be necessary to carry out the Program under this
section.
* * * * * * *
TITLE XIX--GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS
* * * * * * *
PAYMENT TO STATES
Sec. 1903. (a) From the sums appropriated therefor, the
Secretary (except as otherwise provided in this section) shall
pay to each State which has a plan approved under this title,
for each quarter, beginning with the quarter commencing January
1, 1966--
(1) an amount equal to the Federal medical assistance
percentage (as defined in section 1905(b), subject to
subsections (g) and (j) of this section and subsection
1923(f)) of the total amount expended during such
quarter as medical assistance under the State plan;
plus
(2)(A) an amount equal to 75 per centum of so much of
the sums expended during such quarter (as found
necessary by the Secretary for the proper and efficient
administration of the State plan) as are attributable
to compensation or training of skilled professional
medical personnel, and staff directly supporting such
personnel, of the State agency or any other public
agency; plus
(B) notwithstanding paragraph (1) or subparagraph
(A), with respect to amounts expended for nursing aide
training and competency evaluation programs, and
competency evaluation programs, described in section
1919(e)(1) (including the costs for nurse aides to
complete such competency evaluation programs),
regardless of whether the programs are provided in or
outside nursing facilities or of the skill of the
personnel involved in such programs, an amount equal to
50 percent (or, for calendar quarters beginning on or
after July 1, 1988, and before October 1, 1990, the
lesser of 90 percent or the Federal medical assistance
percentage plus 25 percentage points) of so much of the
sums expended during such quarter (as found necessary
by the Secretary for the proper and efficient
administration of the State plan) as are attributable
to such programs; plus
(C) an amount equal to 75 percent of so much of the
sums expended during such quarter (as found necessary
by the Secretary for the proper and efficient
administration of the State plan) as are attributable
to preadmission screening and resident review
activities conducted by the State under section
1919(e)(7); plus
(D) for each calendar quarter during--
(i) fiscal year 1991, an amount equal to 90
percent,
(ii) fiscal year 1992, an amount equal to 85
percent,
(iii) fiscal year 1993, an amount equal to 80
percent, and
(iv) fiscal year 1994 and thereafter, an
amount equal to 75 percent,
of so much of the sums expended during such quarter (as
found necessary by the Secretary for the proper and
efficient administration of the State plan) as are
attributable to State activities under section 1919(g);
plus
(E) an amount equal to 75 percent of so much of the
sums expended during such quarter (as found necessary
by the Secretary for the proper and efficient
administration of the State plan) as are attributable
to translation or interpretation services in connection
with the enrollment of, retention of, and use of
services under this title by, children of families for
whom English is not the primary language; plus
(3) an amount equal to--
(A)(i) 90 per centum of so much of the sums
expended during such quarter as are
attributable to the design, development, or
installation of such mechanized claims
processing and information retrieval systems as
the Secretary determines are likely to provide
more efficient, economical, and effective
administration of the plan and to be compatible
with the claims processing and information
retrieval systems utilized in the
administration of title XVIII, including the
State's share of the cost of installing such a
system to be used jointly in the administration
of such State's plan and the plan of any other
State approved under this title,
(ii) 90 per centum of so much of the sums
expended during any such quarter in the fiscal
year ending June 30, 1972, or the fiscal year
ending June 30, 1973, as are attributable to
the design, development, or installation of
cost determination systems for State-owned
general hospitals (except that the total amount
paid to all States under this clause for either
such fiscal year shall not exceed $150,000),
and
(iii) an amount equal to the Federal medical
assistance percentage (as defined in section
1905(b)) of so much of the sums expended during
such quarter (as found necessary by the
Secretary for the proper and efficient
administration of the State plan) as are
attributable to such developments or
modifications of systems of the type described
in clause (i) as are necessary for the
efficient collection and reporting on child
health measures; and
(B) 75 per centum of so much of the sums
expended during such quarter as are
attributable to the operation of systems
(whether such systems are operated directly by
the State or by another person under a contract
with the State) of the type described in
subparagraph (A)(i) (whether or not designed,
developed, or installed with assistance under
such subparagraph) which are approved by the
Secretary and which include provision for
prompt written notice to each individual who is
furnished services covered by the plan, or to
each individual in a sample group of
individuals who are furnished such services, of
the specific services (other than confidential
services) so covered, the name of the person or
persons furnishing the services, the date or
dates on which the services were furnished, and
the amount of the payment or payments made
under the plan on account of the services; and
(C)(i) 75 per centum of the sums expended
with respect to costs incurred during such
quarter (as found necessary by the Secretary
for the proper and efficient administration of
the State plan) as are attributable to the
performance of medical and utilization review
by a utilization and quality control peer
review organization or by an entity which meets
the requirements of section 1152, as determined
by the Secretary, under a contract entered into
under section 1902(d); and
(ii) 75 percent of the sums expended with
respect to costs incurred during such quarter
(as found necessary by the Secretary for the
proper and efficient administration of the
State plan) as are attributable to the
performance of independent external reviews
conducted under section 1932(c)(2); and
(D) 75 percent of so much of the sums
expended by the State plan during a quarter in
1991, 1992, or 1993, as the Secretary
determines is attributable to the statewide
adoption of a drug use review program which
conforms to the requirements of section
1927(g);
(E) 50 percent of the sums expended with
respect to costs incurred during such quarter
as are attributable to providing--
(i) services to identify and educate
individuals who are likely to be
eligible for medical assistance under
this title and who have Sickle Cell
Disease or who are carriers of the
sickle cell gene, including education
regarding how to identify such
individuals; or
(ii) education regarding the risks of
stroke and other complications, as well
as the prevention of stroke and other
complications, in individuals who are
likely to be eligible for medical
assistance under this title and who
have Sickle Cell Disease; and
(F)(i) 100 percent of so much of the sums
expended during such quarter as are
attributable to payments to Medicaid providers
described in subsection (t)(1) to encourage the
adoption and use of certified EHR technology;
and
(ii) 90 percent of so much of the sums
expended during such quarter as are
attributable to payments for reasonable
administrative expenses related to the
administration of payments described in clause
(i) if the State meets the condition described
in subsection (t)(9); plus
(H)(i) 90 percent of the sums expended during
the quarter as are attributable to the design,
development, or installation of such mechanized
verification and information retrieval systems
as the Secretary determines are necessary to
implement section 1902(ee) (including a system
described in paragraph (2)(B) thereof), and
(ii) 75 percent of the sums expended during
the quarter as are attributable to the
operation of systems to which clause (i)
applies, plus
(4) an amount equal to 100 percent of the sums
expended during the quarter which are attributable to
the costs of the implementation and operation of the
immigration status verification system described in
section 1137(d); plus
(5) an amount equal to 90 per centum of the sums
expended during such quarter which are attributable to
the offering, arranging, and furnishing (directly or on
a contract basis) of family planning services and
supplies;
(6) subject to subsection (b)(3), an amount equal
to--
(A) 90 per centum of the sums expended during
such a quarter within the twelve-quarter period
beginning with the first quarter in which a
payment is made to the State pursuant to this
paragraph, and
(B) 75 per centum of the sums expended during
each succeeding calendar quarter,
with respect to costs incurred during such quarter (as
found necessary by the Secretary for the elimination of
fraud in the provision and administration of medical
assistance provided under the State plan) which are
attributable to the establishment and operation of
(including the training of personnel employed by) a
State medicaid fraud control unit (described in
subsection (q)); plus
(7) subject to section 1919(g)(3)(B), an amount equal
to 50 per centum of the remainder of the amounts
expended during such quarter as found necessary by the
Secretary for the proper and efficient administration
of the State plan.
(b)(1) Notwithstanding the preceding provisions of this
section, the amount determined under subsection (a)(1) for any
State for any quarter beginning after December 31, 1969, shall
not take into account any amounts expended as medical
assistance with respect to individuals aged 65 or over and
disabled individuals entitled to hospital insurance benefits
under title XVIII which would not have been so expended if the
individuals involved had been enrolled in the insurance program
established by part B of title XVIII, other than amounts
expended under provisions of the plan of such State required by
section 1902(a)(34).
(2) For limitation on Federal participation for capital
expenditures which are out of conformity with a comprehensive
plan of a State or areawide planning agency, see section 1122.
(3) The amount of funds which the Secretary is otherwise
obligated to pay a State during a quarter under subsection
(a)(6) may not exceed the higher of--
(A) $125,000, or
(B) one-quarter of 1 per centum of the sums expended
by the Federal, State, and local governments during the
previous quarter in carrying out the State's plan under
this title.
(4) Amounts expended by a State for the use of an enrollment
broker in marketing medicaid managed care organizations and
other managed care entities to eligible individuals under this
title shall be considered, for purposes of subsection (a)(7),
to be necessary for the proper and efficient administration of
the State plan but only if the following conditions are met
with respect to the broker:
(A) The broker is independent of any such entity and
of any health care providers (whether or not any such
provider participates in the State plan under this
title) that provide coverage of services in the same
State in which the broker is conducting enrollment
activities.
(B) No person who is an owner, employee, consultant,
or has a contract with the broker either has any direct
or indirect financial interest with such an entity or
health care provider or has been excluded from
participation in the program under this title or title
XVIII or debarred by any Federal agency, or subject to
a civil money penalty under this Act.
(5) Notwithstanding the preceding provisions of this section,
the amount determined under subsection (a)(1) for any State
shall be decreased in a quarter by the amount of any health
care related taxes (described in section 1902(w)(3)(A)) that
are imposed on a hospital described in subsection (w)(3)(F) in
that quarter.
(c) Nothing in this title shall be construed as prohibiting
or restricting, or authorizing the Secretary to prohibit or
restrict, payment under subsection (a) for medical assistance
for covered services furnished to a child with a disability
because such services are included in the child's
individualized education program established pursuant to part B
of the Individuals with Disabilities Education Act or furnished
to an infant or toddler with a disability because such services
are included in the child's individualized family service plan
adopted pursuant to part C of such Act.
(d)(1) Prior to the beginning of each quarter, the Secretary
shall estimate the amount to which a State will be entitled
under subsections (a) and (b) for such quarter, such estimates
to be based on (A) a report filed by the State containing its
estimate of the total sum to be expended in such quarter in
accordance with the provisions of such subsections, and stating
the amount appropriated or made available by the State and its
political subdivisions for such expenditures in such quarter,
and if such amount is less than the State's proportionate share
of the total sum of such estimated expenditures, the source or
sources from which the difference is expected to be derived,
and (B) such other investigation as the Secretary may find
necessary.
(2)(A) The Secretary shall then pay to the State, in such
installments as he may determine, the amount so estimated,
reduced or increased to the extent of any overpayment or
underpayment which the Secretary determines was made under this
section to such State for any prior quarter and with respect to
which adjustment has not already been made under this
subsection.
(B) Expenditures for which payments were made to the State
under subsection (a) shall be treated as an overpayment to the
extent that the State or local agency administering such plan
has been reimbursed for such expenditures by a third party
pursuant to the provisions of its plan in compliance with
section 1902(a)(25).
(C) For purposes of this subsection, when an overpayment is
discovered, which was made by a State to a person or other
entity, the State shall have a period of 1 year in which to
recover or attempt to recover such overpayment before
adjustment is made in the Federal payment to such State on
account of such overpayment. Except as otherwise provided in
subparagraph (D), the adjustment in the Federal payment shall
be made at the end of the 1-year period, whether or not
recovery was made.
(D)(i) In any case where the State is unable to recover a
debt which represents an overpayment (or any portion thereof)
made to a person or other entity on account of such debt having
been discharged in bankruptcy or otherwise being uncollectable,
no adjustment shall be made in the Federal payment to such
State on account of such overpayment (or portion thereof).
(ii) In any case where the State is unable to recover a debt
which represents an overpayment (or any portion thereof) made
to a person or other entity due to fraud within 1 year of
discovery because there is not a final determination of the
amount of the overpayment under an administrative or judicial
process (as applicable), including as a result of a judgment
being under appeal, no adjustment shall be made in the Federal
payment to such State on account of such overpayment (or
portion thereof) before the date that is 30 days after the date
on which a final judgment (including, if applicable, a final
determination on an appeal) is made.
(3)(A) The pro rata share to which the United States is
equitably entitled, as determined by the Secretary, of the net
amount recovered during any quarter by the State or any
political subdivision thereof with respect to medical
assistance furnished under the State plan shall be considered
an overpayment to be adjusted under this subsection.
(B)(i) Subparagraph (A) and paragraph (2)(B) shall not apply
to any amount recovered or paid to a State as part of the
comprehensive settlement of November 1998 between manufacturers
of tobacco products, as defined in section 5702(d) of the
Internal Revenue Code of 1986, and State Attorneys General, or
as part of any individual State settlement or judgment reached
in litigation initiated or pursued by a State against one or
more such manufacturers.
(ii) Except as provided in subsection (i)(19), a State may
use amounts recovered or paid to the State as part of a
comprehensive or individual settlement, or a judgment,
described in clause (i) for any expenditures determined
appropriate by the State.
(4) Upon the making of any estimate by the Secretary under
this subsection, any appropriations available for payments
under this section shall be deemed obligated.
(5) In any case in which the Secretary estimates that there
has been an overpayment under this section to a State on the
basis of a claim by such State that has been disallowed by the
Secretary under section 1116(d), and such State disputes such
disallowance, the amount of the Federal payment in controversy
shall, at the option of the State, be retained by such State or
recovered by the Secretary pending a final determination with
respect to such payment amount. If such final determination is
to the effect that any amount was properly disallowed, and the
State chose to retain payment of the amount in controversy, the
Secretary shall offset, from any subsequent payments made to
such State under this title, an amount equal to the proper
amount of the disallowance plus interest on such amount
disallowed for the period beginning on the date such amount was
disallowed and ending on the date of such final determination
at a rate (determined by the Secretary) based on the average of
the bond equivalent of the weekly 90-day treasury bill auction
rates during such period.
(6)(A) Each State (as defined in subsection (w)(7)(D)) shall
include, in the first report submitted under paragraph (1)
after the end of each fiscal year, information related to--
(i) provider-related donations made to the State or
units of local government during such fiscal year, and
(ii) health care related taxes collected by the State
or such units during such fiscal year.
(B) Each State shall include, in the first report submitted
under paragraph (1) after the end of each fiscal year,
information related to the total amount of payment adjustments
made, and the amount of payment adjustments made to individual
providers (by provider), under section 1923(c) during such
fiscal year.
(e) A State plan approved under this title may include, as a
cost with respect to hospital services under the plan under
this title, periodic expenditures made to reflect transitional
allowances established with respect to a hospital closure or
conversion under section 1884.
(f)(1)(A) Except as provided in paragraph (4), payment under
the preceding provisions of this section shall not be made with
respect to any amount expended as medical assistance in a
calendar quarter, in any State, for any member of a family the
annual income of which exceeds the applicable income limitation
determined under this paragraph.
(B)(i) Except as provided in clause (ii) of this
subparagraph, the applicable income limitation with respect to
any family is the amount determined, in accordance with
standards prescribed by the Secretary, to be equivalent to
133\1/3\ percent of the highest amount which would ordinarily
be paid to a family of the same size without any income or
resources, in the form of money payments, under the plan of the
State approved under part A of title IV of this Act.
(ii) If the Secretary finds that the operation of a uniform
maximum limits payments to families of more than one size, he
may adjust the amount otherwise determined under clause (i) to
take account of families of different sizes.
(C) The total amount of any applicable income limitation
determined under subparagraph (B) shall, if it is not a
multiple of $100 or such other amount as the Secretary may
prescribe, be rounded to the next higher multiple of $100 or
such other amount, as the case may be.
(2)(A) In computing a family's income for purposes of
paragraph (1), there shall be excluded any costs (whether in
the form of insurance premiums or otherwise and regardless of
whether such costs are reimbursed under another public program
of the State or political subdivision thereof) incurred by such
family for medical care or for any other type of remedial care
recognized under State law or, (B) notwithstanding section 1916
at State option, an amount paid by such family, at the family's
option, to the State, provided that the amount, when combined
with costs incurred in prior months, is sufficient when
excluded from the family's income to reduce such family's
income below the applicable income limitation described in
paragraph (1). The amount of State expenditures for which
medical assistance is available under subsection (a)(1) will be
reduced by amounts paid to the State pursuant to this
subparagraph.
(3) For purposes of paragraph (1)(B), in the case of a family
consisting of only one individual, the ``highest amount which
would ordinarily be paid'' to such family under the State's
plan approved under part A of title IV of this Act shall be the
amount determined by the State agency (on the basis of
reasonable relationship to the amounts payable under such plan
to families consisting of two or more persons) to be the amount
of the aid which would ordinarily be payable under such plan to
a family (without any income or resources) consisting of one
person if such plan provided for aid to such a family.
(4) The limitations on payment imposed by the preceding
provisions of this subsection shall not apply with respect to
any amount expended by a State as medical assistance for any
individual described in section 1902(a)(10)(A)(i)(III),
1902(a)(10)(A)(i)(IV), 1902(a)(10)(A)(i)(V),
1902(a)(10)(A)(i)(VI), 1902(a)(10)(A)(i)(VII),
1902(a)(10)(A)(i)(VIII),1902(a)(10)(A)(i)(IX),
1902(a)(10)(A)(ii)(IX), 1902(a)(10)(A)(ii)(X),
1902(a)(10)(A)(ii)(XIII), 1902(a)(10)(A)(ii)(XIV), or
1902(a)(10)(A)(ii)(XV), 1902(a)(10)(A)(ii)(XVI),
1902(a)(10)(A)(ii)(XVII), 1902(a)(10)(A)(ii)(XVIII),
1902(a)(10)(A)(ii)(XIX), 1902(a)(10)(A)(ii)(XX),
1902(a)(10)(A)(ii)(XXI), 1902(a)(10)(A)(ii)(XXII), 1905(p)(1)
or for any individual--
(A) who is receiving aid or assistance under any plan
of the State approved under title I, X, XIV or XVI, or
part A of title IV, or with respect to whom
supplemental security income benefits are being paid
under title XVI, or
(B) who is not receiving such aid or assistance, and
with respect to whom such benefits are not being paid,
but (i) is eligible to receive such aid or assistance,
or to have such benefits paid with respect to him, or
(ii) would be eligible to receive such aid or
assistance, or to have such benefits paid with respect
to him if he were not in a medical institution, or
(C) with respect to whom there is being paid, or who
is eligible, or would be eligible if he were not in a
medical institution, to have paid with respect to him,
a State supplementary payment and is eligible for
medical assistance equal in amount, duration, and scope
to the medical assistance made available to individuals
described in section 1902(a)(10)(A), or who is a PACE
program eligible individual enrolled in a PACE program
under section 1934, but only if the income of such
individual (as determined under section 1612, but
without regard to subsection (b) thereof) does not
exceed 300 percent of the supplemental security income
benefit rate established by section 1611(b)(1),
at the time of the provision of the medical assistance giving
rise to such expenditure.
(g)(1) Subject to paragraph (3), with respect to amounts paid
for the following services furnished under the State plan after
June 30, 1973 (other than services furnished pursuant to a
contract with a health maintenance organization as defined in
section 1876 or which is a qualified health maintenance
organization (as defined in section 1310(d) of the Public
Health Service Act)), the Federal medical assistance percentage
shall be decreased as follows: After an individual has received
inpatient hospital services or services in an intermediate care
facility for the mentally retarded for 60 days or inpatient
mental hospital services for 90 days (whether or not such days
are consecutive), during any fiscal year, the Federal medical
assistance percentage with respect to amounts paid for any such
care furnished thereafter to such individual shall be decreased
by a per centum thereof (determined under paragraph (5)) unless
the State agency responsible for the administration of the plan
makes a showing satisfactory to the Secretary that, with
respect to each calendar quarter for which the State submits a
request for payment at the full Federal medical assistance
percentage for amounts paid for inpatient hospital services or
services in an intermediate care facility for the mentally
retarded furnished beyond 60 days (or inpatient mental hospital
services furnished beyond 90 days), such State has an effective
program of medical review of the care of patients in mental
hospitals and intermediate care facilities for the mentally
retarded pursuant to paragraphs (26) and (31) of section
1902(a) whereby the professional management of each case is
reviewed and evaluated at least annually by independent
professional review teams. In determining the number of days on
which an individual has received services described in this
subsection, there shall not be counted any days with respect to
which such individual is entitled to have payments made (in
whole or in part) on his behalf under section 1812.
(2) The Secretary shall, as part of his validation procedures
under this subsection, conduct timely sample onsite surveys of
private and public institutions in which recipients of medical
assistance may receive care and services under a State plan
approved under this title, and his findings with respect to
such surveys (as well as the showings of the State agency
required under this subsection) shall be made available for
public inspection.
(3)(A) No reduction in the Federal medical assistance
percentage of a State otherwise required to be imposed under
this subsection shall take effect--
(i) if such reduction is due to the State's
unsatisfactory or invalid showing made with respect to
a calendar quarter beginning before January 1, 1977;
(ii) before January 1, 1978;
(iii) unless a notice of such reduction has been
provided to the State at least 30 days before the date
such reduction takes effect; or
(iv) due to the State's unsatisfactory or invalid
showing made with respect to a calendar quarter
beginning after September 30, 1977, unless notice of
such reduction has been provided to the State no later
than the first day of the fourth calendar quarter
following the calendar quarter with respect to which
such showing was made.
(B) The Secretary shall waive application of any reduction in
the Federal medical assistance percentage of a State otherwise
required to be imposed under paragraph (1) because a showing by
the State, made under such paragraph with respect to a calendar
quarter ending after January 1, 1977, and before January 1,
1978, is determined to be either unsatisfactory under such
paragraph or invalid under paragraph (2), if the Secretary
determines that the State's showing made under paragraph (1)
with respect to any calendar quarter ending on or before
December 31, 1978, is satisfactory under such paragraph and is
valid under paragraph (2).
(4)(A) The Secretary may not find the showing of a State,
with respect to a calendar quarter under paragraph (1), to be
satisfactory if the showing is submitted to the Secretary later
than the 30th day after the last day of the calendar quarter,
unless the State demonstrates to the satisfaction of the
Secretary good cause for not meeting such deadline.
(B) The Secretary shall find a showing of a State, with
respect to a calendar quarter under paragraph (1), to be
satisfactory under such paragraph with respect to the
requirement that the State conduct annual onsite inspections in
mental hospitals and intermediate care facilities for the
mentally retarded under paragraphs (26) and (31) of section
1902(a), if the showing demonstrates that the State has
conducted such an onsite inspection during the 12-month period
ending on the last date of the calendar quarter--
(i) in each of not less than 98 per centum of the
number of such hospitals and facilities requiring such
inspection, and
(ii) in every such hospital or facility which has 200
or more beds,
and that, with respect to such hospitals and facilities not
inspected within such period, the State has exercised good
faith and due diligence in attempting to conduct such
inspection, or if the State demonstrates to the satisfaction of
the Secretary that it would have made such a showing but for
failings of a technical nature only.
(5) In the case of a State's unsatisfactory or invalid
showing made with respect to a type of facility or
institutional services in a calendar quarter, the per centum
amount of the reduction of the State's Federal medical
assistance percentage for that type of services under paragraph
(1) is equal to 33\1/3\ per centum multiplied by a fraction,
the denominator of which is equal to the total number of
patients receiving that type of services in that quarter under
the State plan in facilities or institutions for which a
showing was required to be made under this subsection, and the
numerator of which is equal to the number of such patients
receiving such type of services in that quarter in those
facilities or institutions for which a satisfactory and valid
showing was not made for that calendar quarter.
(6)(A) Recertifications required under section 1902(a)(44)
shall be conducted at least every 60 days in the case of
inpatient hospital services.
(B) Such recertifications in the case of services in an
intermediate care facility for the mentally retarded shall be
conducted at least--
(i) 60 days after the date of the initial
certification,
(ii) 180 days after the date of the initial
certification,
(iii) 12 months after the date of the initial
certification,
(iv) 18 months after the date of the initial
certification,
(v) 24 months after the date of the initial
certification, and
(vi) every 12 months thereafter.
(C) For purposes of determining compliance with the schedule
established by this paragraph, a recertification shall be
considered to have been done on a timely basis if it was
performed not later than 10 days after the date the
recertification was otherwise required and the State
establishes good cause why the physician or other person making
such recertification did not meet such schedule.
(i) Payment under the preceding provisions of this section
shall not be made--
(1) for organ transplant procedures unless the State
plan provides for written standards respecting the
coverage of such procedures and unless such standards
provide that--
(A) similarly situated individuals are
treated alike; and
(B) any restriction, on the facilities or
practitioners which may provide such
procedures, is consistent with the
accessibility of high quality care to
individuals eligible for the procedures under
the State plan; or
(2) with respect to any amount expended for an item
or service (other than an emergency item or service,
not including items or services furnished in an
emergency room of a hospital) furnished--
(A) under the plan by any individual or
entity during any period when the individual or
entity is excluded from participation under
title V, XVIII, or XX or under this title
pursuant to section 1128, 1128A, 1156, or
1842(j)(2);
(B) at the medical direction or on the
prescription of a physician, during the period
when such physician is excluded from
participation under title V, XVIII, or XX or
under this title pursuant to section 1128,
1128A, 1156, or 1842(j)(2) and when the person
furnishing such item or service knew or had
reason to know of the exclusion (after a
reasonable time period after reasonable notice
has been furnished to the person);
(C) by any individual or entity to whom the
State has failed to suspend payments under the
plan during any period when there is pending an
investigation of a credible allegation of fraud
against the individual or entity, as determined
by the State in accordance with regulations
promulgated by the Secretary for purposes of
section 1862(o) and this subparagraph, unless
the State determines in accordance with such
regulations there is good cause not to suspend
such payments;
(D) beginning on July 1, 2018, under the plan
by any provider of services or person whose
participation in the State plan is terminated
(as described in section 1902(kk)(8)) after the
date that is 60 days after the date on which
such termination is included in the database or
other system under section 1902(ll); or
(E) with respect to any amount expended for
such an item or service furnished during
calendar quarters beginning on or after October
1, 2017, subject to section
1902(kk)(4)(A)(ii)(II), within a geographic
area that is subject to a moratorium imposed
under section 1866(j)(7) by a provider or
supplier that meets the requirements specified
in subparagraph (C)(iii) of such section,
during the period of such moratorium; or
(3) with respect to any amount expended for inpatient
hospital services furnished under the plan (other than
amounts attributable to the special situation of a
hospital which serves a disproportionate number of low
income patients with special needs) to the extent that
such amount exceeds the hospital's customary charges
with respect to such services or (if such services are
furnished under the plan by a public institution free
of charge or at nominal charges to the public) exceeds
an amount determined on the basis of those items
(specified in regulations prescribed by the Secretary)
included in the determination of such payment which the
Secretary finds will provide fair compensation to such
institution for such services; or
(4) with respect to any amount expended for care or
services furnished under the plan by a hospital unless
such hospital has in effect a utilization review plan
which meets the requirements imposed by section 1861(k)
for purposes of title XVIII; and if such hospital has
in effect such a utilization review plan for purposes
of title XVIII, such plan shall serve as the plan
required by this subsection (with the same standards
and procedures and the same review committee or group)
as a condition of payment under this title; the
Secretary is authorized to waive the requirements of
this paragraph if the State agency demonstrates to his
satisfaction that it has in operation utilization
review procedures which are superior in their
effectiveness to the procedures required under section
1861(k); or
(5) with respect to any amount expended for any drug
product for which payment may not be made under part B
of title XVIII because of section 1862(c); or
(6) with respect to any amount expended for inpatient
hospital tests (other than in emergency situations) not
specifically ordered by the attending physician or
other responsible practitioner; or
(7) with respect to any amount expended for clinical
diagnostic laboratory tests performed by a physician,
independent laboratory, or hospital, to the extent such
amount exceeds the amount that would be recognized
under section 1833(h) for such tests performed for an
individual enrolled under part B of title XVIII; or
(8) with respect to any amount expended for medical
assistance (A) for nursing facility services to
reimburse (or otherwise compensate) a nursing facility
for payment of a civil money penalty imposed under
section 1919(h) or (B) for home and community care to
reimburse (or otherwise compensate) a provider of such
care for payment of a civil money penalty imposed under
this title or title XI or for legal expenses in defense
of an exclusion or civil money penalty under this title
or title XI if there is no reasonable legal ground for
the provider's case; or
(9) with respect to any amount expended for non-
emergency transportation authorized under section
1902(a)(4), unless the State plan provides for the
methods and procedures required under section
1902(a)(30)(A); or
(10)(A) with respect to covered outpatient drugs
unless there is a rebate agreement in effect under
section 1927 with respect to such drugs or unless
section 1927(a)(3) applies,
(B) with respect to any amount expended for an
innovator multiple source drug (as defined in section
1927(k)) dispensed on or after July 1, 1991, if, under
applicable State law, a less expensive multiple source
drug could have been dispensed, but only to the extent
that such amount exceeds the upper payment limit for
such multiple source drug;
(C) with respect to covered outpatient drugs
described in section 1927(a)(7), unless information
respecting utilization data and coding on such drugs
that is required to be submitted under such section is
submitted in accordance with such section;
(D) with respect to any amount expended for
reimbursement to a pharmacy under this title for the
ingredient cost of a covered outpatient drug for which
the pharmacy has already received payment under this
title (other than with respect to a reasonable
restocking fee for such drug); and
(E) with respect to any amount expended for a covered
outpatient drug for which a suspension under section
1927(c)(4)(B)(ii)(II) is in effect; or
(11) with respect to any amount expended for
physicians' services furnished on or after the first
day of the first quarter beginning more than 60 days
after the date of establishment of the physician
identifier system under section 1902(x), unless the
claim for the services includes the unique physician
identifier provided under such system; or
(12) with respect to any amounts expended for--
(A) a vacuum erection system that is not
medically necessary; or
(B) the insertion, repair, or removal and
replacement of a penile prosthetic implant
(unless such insertion, repair, or removal and
replacement is medically necessary); or
(13) with respect to any amount expended to reimburse
(or otherwise compensate) a nursing facility for
payment of legal expenses associated with any action
initiated by the facility that is dismissed on the
basis that no reasonable legal ground existed for the
institution of such action; or
(14) with respect to any amount expended on
administrative costs to carry out the program under
section 1928; or
(15) with respect to any amount expended for a
single-antigen vaccine and its administration in any
case in which the administration of a combined-antigen
vaccine was medically appropriate (as determined by the
Secretary); or
(16) with respect to any amount expended for which
funds may not be used under the Assisted Suicide
Funding Restriction Act of 1997; or
(17) with respect to any amount expended for roads,
bridges, stadiums, or any other item or service not
covered under a State plan under this title; or
(18) with respect to any amount expended for home
health care services provided by an agency or
organization unless the agency or organization provides
the State agency on a continuing basis a surety bond in
a form specified by the Secretary under paragraph (7)
of section 1861(o) and in an amount that is not less
than $50,000 or such comparable surety bond as the
Secretary may permit under the last sentence of such
section; or
(19) with respect to any amount expended on
administrative costs to initiate or pursue litigation
described in subsection (d)(3)(B);
(20) with respect to amounts expended for medical
assistance provided to an individual described in
subclause (XV) or (XVI) of section 1902(a)(10)(A)(ii)
for a fiscal year unless the State demonstrates to the
satisfaction of the Secretary that the level of State
funds expended for such fiscal year for programs to
enable working individuals with disabilities to work
(other than for such medical assistance) is not less
than the level expended for such programs during the
most recent State fiscal year ending before the date of
the enactment of this paragraph;
(21) with respect to amounts expended for covered
outpatient drugs described in section 1927(d)(2)(C)
(relating to drugs when used for cosmetic purposes or
hair growth), except where medically necessary, and
section 1927(d)(2)(K) (relating to drugs when used for
treatment of sexual or erectile dysfunction);
(22) with respect to amounts expended for medical
assistance for an individual who declares under section
1137(d)(1)(A) to be a citizen or national of the United
States for purposes of establishing eligibility for
benefits under this title, unless the requirement of
section 1902(a)(46)(B) is met;
(23) with respect to amounts expended for medical
assistance for covered outpatient drugs (as defined in
section 1927(k)(2)) for which the prescription was
executed in written (and non-electronic) form unless
the prescription was executed on a tamper-resistant
pad;
(24) if a State is required to implement an asset
verification program under section 1940 and fails to
implement such program in accordance with such section,
with respect to amounts expended by such State for
medical assistance for individuals subject to asset
verification under such section, unless--
(A) the State demonstrates to the Secretary's
satisfaction that the State made a good faith
effort to comply;
(B) not later than 60 days after the date of
a finding that the State is in noncompliance,
the State submits to the Secretary (and the
Secretary approves) a corrective action plan to
remedy such noncompliance; and
(C) not later than 12 months after the date
of such submission (and approval), the State
fulfills the terms of such corrective action
plan;
(25) with respect to any amounts expended for medical
assistance for individuals for whom the State does not
report enrollee encounter data (as defined by the
Secretary) to the Medicaid Statistical Information
System (MSIS) in a timely manner (as determined by the
Secretary);
(26) with respect to any amounts expended for medical
assistance for individuals described in subclause
(VIII) of subsection (a)(10)(A)(i) other than medical
assistance provided through benchmark coverage
described in section 1937(b)(1) or benchmark equivalent
coverage described in section 1937(b)(2); or
(27) with respect to any amounts expended by the
State on the basis of a fee schedule for items
described in section 1861(n) and furnished on or after
January 1, 2018, as determined in the aggregate with
respect to each class of such items as defined by the
Secretary, in excess of the aggregate amount, if any,
that would be paid for such items within such class on
a fee-for-service basis under the program under part B
of title XVIII, including, as applicable, under a
competitive acquisition program under section 1847 in
an area of the State.
Nothing in paragraph (1) shall be construed as permitting a
State to provide services under its plan under this title that
are not reasonable in amount, duration, and scope to achieve
their purpose. Paragraphs (1), (2), (16), (17), and (18) shall
apply with respect to items or services furnished and amounts
expended by or through a managed care entity (as defined in
section 1932(a)(1)(B)) in the same manner as such paragraphs
apply to items or services furnished and amounts expended
directly by the State.
(j) Notwithstanding the preceding provisions of this section,
the amount determined under subsection (a)(1) for any State for
any quarter shall be adjusted in accordance with section 1914.
(k) The Secretary is authorized to provide at the request of
any State (and without cost to such State) such technical and
actuarial assistance as may be necessary to assist such State
to contract with any medicaid managed care organization which
meets the requirements of subsection (m) of this section for
the purpose of providing medical care and services to
individuals who are entitled to medical assistance under this
title.
(l)(1) Subject to paragraphs (3) and (4), with respect to any
amount expended for personal care services or home health care
services requiring an in-home visit by a provider that are
provided under a State plan under this title (or under a waiver
of the plan) and furnished in a calendar quarter beginning on
or after January 1, 2020 (or, in the case of home health care
services, on or after January 1, 2023), unless a State requires
the use of an electronic visit verification system for such
services furnished in such quarter under the plan or such
waiver, the Federal medical assistance percentage shall be
reduced--
(A) in the case of personal care services--
(i) for calendar quarters in 2020, by .25
percentage points;
(ii) for calendar quarters in 2021, by .5
percentage points;
(iii) for calendar quarters in 2022, by .75
percentage points; and
(iv) for calendar quarters in 2023 and each
year thereafter, by 1 percentage point; and
(B) in the case of home health care services--
(i) for calendar quarters in 2023 and 2024,
by .25 percentage points;
(ii) for calendar quarters in 2025, by .5
percentage points;
(iii) for calendar quarters in 2026, by .75
percentage points; and
(iv) for calendar quarters in 2027 and each
year thereafter, by 1 percentage point.
(2) Subject to paragraphs (3) and (4), in implementing the
requirement for the use of an electronic visit verification
system under paragraph (1), a State shall--
(A) consult with agencies and entities that provide
personal care services, home health care services, or
both under the State plan (or under a waiver of the
plan) to ensure that such system--
(i) is minimally burdensome;
(ii) takes into account existing best
practices and electronic visit verification
systems in use in the State; and
(iii) is conducted in accordance with the
requirements of HIPAA privacy and security law
(as defined in section 3009 of the Public
Health Service Act);
(B) take into account a stakeholder process that
includes input from beneficiaries, family caregivers,
individuals who furnish personal care services or home
health care services, and other stakeholders, as
determined by the State in accordance with guidance
from the Secretary; and
(C) ensure that individuals who furnish personal care
services, home health care services, or both under the
State plan (or under a waiver of the plan) are provided
the opportunity for training on the use of such system.
(3) Paragraphs (1) and (2) shall not apply in the case of a
State that, as of the date of the enactment of this subsection,
requires the use of any system for the electronic verification
of visits conducted as part of both personal care services and
home health care services, so long as the State continues to
require the use of such system with respect to the electronic
verification of such visits.
(4)(A) In the case of a State described in subparagraph (B),
the reduction under paragraph (1) shall not apply--
(i) in the case of personal care services, for
calendar quarters in 2020; and
(ii) in the case of home health care services, for
calendar quarters in 2023.
(B) For purposes of subparagraph (A), a State described in
this subparagraph is a State that demonstrates to the Secretary
that the State--
(i) has made a good faith effort to comply with the
requirements of paragraphs (1) and (2) (including by
taking steps to adopt the technology used for an
electronic visit verification system); and
(ii) in implementing such a system, has encountered
unavoidable system delays.
(5) In this subsection:
(A) The term ``electronic visit verification system''
means, with respect to personal care services or home
health care services, a system under which visits
conducted as part of such services are electronically
verified with respect to--
(i) the type of service performed;
(ii) the individual receiving the service;
(iii) the date of the service;
(iv) the location of service delivery;
(v) the individual providing the service; and
(vi) the time the service begins and ends.
(B) The term ``home health care services'' means
services described in section 1905(a)(7) provided under
a State plan under this title (or under a waiver of the
plan).
(C) The term ``personal care services'' means
personal care services provided under a State plan
under this title (or under a waiver of the plan),
including services provided under section 1905(a)(24),
1915(c), 1915(i), 1915(j), or 1915(k) or under a wavier
under section 1115.
(6)(A) In the case in which a State requires personal care
service and home health care service providers to utilize an
electronic visit verification system operated by the State or a
contractor on behalf of the State, the Secretary shall pay to
the State, for each quarter, an amount equal to 90 per centum
of so much of the sums expended during such quarter as are
attributable to the design, development, or installation of
such system, and 75 per centum of so much of the sums for the
operation and maintenance of such system.
(B) Subparagraph (A) shall not apply in the case in which a
State requires personal care service and home health care
service providers to utilize an electronic visit verification
system that is not operated by the State or a contractor on
behalf of the State.
(m)(1)(A) The term ``medicaid managed care organization''
means a health maintenance organization, an eligible
organization with a contract under section 1876 or a
Medicare+Choice organization with a contract under part C of
title XVIII, a provider sponsored organization, or any other
public or private organization, which meets the requirement of
section 1902(w) and--
(i) makes services it provides to individuals
eligible for benefits under this title accessible to
such individuals, within the area served by the
organization, to the same extent as such services are
made accessible to individuals (eligible for medical
assistance under the State plan) not enrolled with the
organization, and
(ii) has made adequate provision against the risk of
insolvency, which provision is satisfactory to the
State, meets the requirements of subparagraph (C)(i)
(if applicable), and which assures that individuals
eligible for benefits under this title are in no case
held liable for debts of the organization in case of
the organization's insolvency.
An organization that is a qualified health maintenance
organization (as defined in section 1310(d) of the Public
Health Service Act) is deemed to meet the requirements of
clauses (i) and (ii).
(B) The duties and functions of the Secretary, insofar as
they involve making determinations as to whether an
organization is a medicaid managed care organization within the
meaning of subparagraph (A), shall be integrated with the
administration of section 1312 (a) and (b) of the Public Health
Service Act.
(C)(i) Subject to clause (ii), a provision meets the
requirements of this subparagraph for an organization if the
organization meets solvency standards established by the State
for private health maintenance organizations or is licensed or
certified by the State as a risk-bearing entity.
(ii) Clause (i) shall not apply to an organization if--
(I) the organization is not responsible for the
provision (directly or through arrangements with
providers of services) of inpatient hospital services
and physicians' services;
(II) the organization is a public entity;
(III) the solvency of the organization is guaranteed
by the State; or
(IV) the organization is (or is controlled by) one or
more Federally-qualified health centers and meets
solvency standards established by the State for such an
organization.
For purposes of subclause (IV), the term ``control'' means the
possession, whether direct or indirect, of the power to direct
or cause the direction of the management and policies of the
organization through membership, board representation, or an
ownership interest equal to or greater than 50.1 percent.
(2)(A) Except as provided in subparagraphs (B), (C), and (G),
no payment shall be made under this title to a State with
respect to expenditures incurred by it for payment (determined
under a prepaid capitation basis or under any other risk basis)
for services provided by any entity (including a health
insuring organization) which is responsible for the provision
(directly or through arrangements with providers of services)
of inpatient hospital services and any other service described
in paragraph (2), (3), (4), (5), or (7) of section 1905(a) or
for the provision of any three or more of the services
described in such paragraphs unless--
(i) the Secretary has determined that the entity is a
medicaid managed care organization organization as
defined in paragraph (1);
(iii) such services are provided for the benefit of
individuals eligible for benefits under this title in
accordance with a contract between the State and the
entity under which prepaid payments to the entity are
made on an actuarially sound basis and under which the
Secretary must provide prior approval for contracts
providing for expenditures in excess of $1,000,000 for
1998 and, for a subsequent year, the amount established
under this clause for the previous year increased by
the percentage increase in the consumer price index for
all urban consumers over the previous year;
(iv) such contract provides that the Secretary and
the State (or any person or organization designated by
either) shall have the right to audit and inspect any
books and records of the entity (and of any
subcontractor) that pertain (I) to the ability of the
entity to bear the risk of potential financial losses,
or (II) to services performed or determinations of
amounts payable under the contract;
(v) such contract provides that in the entity's
enrollment, reenrollment, or disenrollment of
individuals who are eligible for benefits under this
title and eligible to enroll, reenroll, or disenroll
with the entity pursuant to the contract, the entity
will not discriminate among such individuals on the
basis of their health status or requirements for health
care services;
(vi) such contract (I) permits individuals who have
elected under the plan to enroll with the entity for
provision of such benefits to terminate such enrollment
in accordance with section 1932(a)(4), and (II)
provides for notification in accordance with such
section of each such individual, at the time of the
individual's enrollment, of such right to terminate
such enrollment;
(vii) such contract provides that, in the case of
medically necessary services which were provided (I) to
an individual enrolled with the entity under the
contract and entitled to benefits with respect to such
services under the State's plan and (II) other than
through the organization because the services were
immediately required due to an unforeseen illness,
injury, or condition, either the entity or the State
provides for reimbursement with respect to those
services,
(viii) such contract provides for disclosure of
information in accordance with section 1124 and
paragraph (4) of this subsection;
(ix) such contract provides, in the case of an entity
that has entered into a contract for the provision of
services with a Federally-qualified health center or a
rural health clinic, that the entity shall provide
payment that is not less than the level and amount of
payment which the entity would make for the services if
the services were furnished by a provider which is not
a Federally-qualified health center or a rural health
clinic;
(x) any physician incentive plan that it operates
meets the requirements described in section 1876(i)(8);
(xi) such contract provides for maintenance of
sufficient patient encounter data to identify the
physician who delivers services to patients and for the
provision of such data to the State at a frequency and
level of detail to be specified by the Secretary;
(xii) such contract, and the entity complies with the
applicable requirements of section 1932; and
(xiii) such contract provides that (I)
covered outpatient drugs dispensed to
individuals eligible for medical assistance who
are enrolled with the entity shall be subject
to the same rebate required by the agreement
entered into under section 1927 as the State is
subject to and that the State shall collect
such rebates from manufacturers, (II)
capitation rates paid to the entity shall be
based on actual cost experience related to
rebates and subject to the Federal regulations
requiring actuarially sound rates, and (III)
the entity shall report to the State, on such
timely and periodic basis as specified by the
Secretary in order to include in the
information submitted by the State to a
manufacturer and the Secretary under section
1927(b)(2)(A), information on the total number
of units of each dosage form and strength and
package size by National Drug Code of each
covered outpatient drug dispensed to
individuals eligible for medical assistance who
are enrolled with the entity and for which the
entity is responsible for coverage of such drug
under this subsection (other than covered
outpatient drugs that under subsection (j)(1)
of section 1927 are not subject to the
requirements of that section) and such other
data as the Secretary determines necessary to
carry out this subsection.
(B) Subparagraph (A) except with respect to clause (ix) of
subparagraph (A), does not apply with respect to payments under
this title to a State with respect to expenditures incurred by
it for payment for services provided by an entity which--
(i)(I) received a grant of at least $100,000 in the
fiscal year ending June 30, 1976, under section
329(d)(1)(A) or 330(d)(1) of the Public Health Service
Act, and for the period beginning July 1, 1976, and
ending on the expiration of the period for which
payments are to be made under this title has been the
recipient of a grant under either such section; and
(II) provides to its enrollees, on a prepaid
capitation risk basis or on any other risk basis, all
of the services and benefits described in paragraphs
(1), (2), (3), (4)(C), and (5) of section 1905(a) and,
to the extent required by section 1902(a)(10)(D) to be
provided under a State plan for medical assistance, the
services and benefits described in paragraph (7) of
section 1905(a); or
(ii) is a nonprofit primary health care entity
located in a rural area (as defined by the Appalachian
Regional Commission)--
(I) which received in the fiscal year ending
June 30, 1976, at least $100,000 (by grant,
subgrant, or subcontract) under the Appalachian
Regional Development Act of 1965, and
(II) for the period beginning July 1, 1976,
and ending on the expiration of the period for
which payments are to be made under this title
either has been the recipient of a grant,
subgrant, or subcontract under such Act or has
provided services under a contract (initially
entered into during a year in which the entity
was the recipient of such a grant, subgrant, or
subcontract) with a State agency under this
title on a prepaid capitation risk basis or on
any other risk basis; or
(iii) which has contracted with the single State
agency for the provision of services (but not including
inpatient hospital services) to persons eligible under
this title on a prepaid risk basis prior to 1970.
(G) In the case of an entity which is receiving (and has
received during the previous two years) a grant of at least
$100,000 under section 329(d)(1)(A) or 330(d)(1) of the Public
Health Service Act or is receiving (and has received during the
previous two years) at least $100,000 (by grant, subgrant, or
subcontract) under the Appalachian Regional Development Act of
1965, clause (i) of subparagraph (A) shall not apply.
(H) In the case of an individual who--
(i) in a month is eligible for benefits under this
title and enrolled with a medicaid managed care
organization with a contract under this paragraph or
with a primary care case manager with a contract
described in section 1905(t)(3),
(ii) in the next month (or in the next 2 months) is
not eligible for such benefits, but
(iii) in the succeeding month is again eligible for
such benefits,
the State plan, subject to subparagraph (A)(vi), may enroll the
individual for that succeeding month with the organization
described in clause (i) if the organization continues to have a
contract under this paragraph with the State or with the
manager described in such clause if the manager continues to
have a contract described in section 1905(t)(3) with the State.
(3) No payment shall be made under this title to a State with
respect to expenditures incurred by the State for payment for
services provided by a managed care entity (as defined under
section 1932(a)(1)) under the State plan under this title (or
under a waiver of the plan) unless the State--
(A) beginning on July 1, 2018, has a contract with
such entity that complies with the requirement
specified in section 1932(d)(5); and
(B) beginning on January 1, 2018, complies with the
requirement specified in section 1932(d)(6)(A).
(4)(A) Each medicaid managed care organization which is not a
qualified health maintenance organization (as defined in
section 1310(d) of the Public Health Service Act) must report
to the State and, upon request, to the Secretary, the Inspector
General of the Department of Health and Human Services, and the
Comptroller General a description of transactions between the
organization and a party in interest (as defined in section
1318(b) of such Act), including the following transactions:
(i) Any sale or exchange, or leasing of any property
between the organization and such a party.
(ii) Any furnishing for consideration of goods,
services (including management services), or facilities
between the organization and such a party, but not
including salaries paid to employees for services
provided in the normal course of their employment.
(iii) Any lending of money or other extension of
credit between the organization and such a party.
The State or Secretary may require that information reported
respecting an organization which controls, or is controlled by,
or is under common control with, another entity be in the form
of a consolidated financial statement for the organization and
such entity.
(B) Each organization shall make the information reported
pursuant to subparagraph (A) available to its enrollees upon
reasonable request.
(5)(A) If the Secretary determines that an entity with a
contract under this subsection--
(i) fails substantially to provide medically
necessary items and services that are required (under
law or under the contract) to be provided to an
individual covered under the contract, if the failure
has adversely affected (or has substantial likelihood
of adversely affecting) the individual;
(ii) imposes premiums on individuals enrolled under
this subsection in excess of the premiums permitted
under this title;
(iii) acts to discriminate among individuals in
violation of the provision of paragraph (2)(A)(v),
including expulsion or refusal to re-enroll an
individual or engaging in any practice that would
reasonably be expected to have the effect of denying or
discouraging enrollment (except as permitted by this
subsection) by eligible individuals with the
organization whose medical condition or history
indicates a need for substantial future medical
services;
(iv) misrepresents or falsifies information that is
furnished--
(I) to the Secretary or the State under this
subsection, or
(II) to an individual or to any other entity
under this subsection, or
(v) fails to comply with the requirements of section
1876(i)(8),
the Secretary may provide, in addition to any other remedies
available under law, for any of the remedies described in
subparagraph (B).
(B) The remedies described in this subparagraph are--
(i) civil money penalties of not more than $25,000
for each determination under subparagraph (A), or, with
respect to a determination under clause (iii) or
(iv)(I) of such subparagraph, of not more than $100,000
for each such determination, plus, with respect to a
determination under subparagraph (A)(ii), double the
excess amount charged in violation of such subparagraph
(and the excess amount charged shall be deducted from
the penalty and returned to the individual concerned),
and plus, with respect to a determination under
subparagraph (A)(iii), $15,000 for each individual not
enrolled as a result of a practice described in such
subparagraph, or
(ii) denial of payment to the State for medical
assistance furnished under the contract under this
subsection for individuals enrolled after the date the
Secretary notifies the organization of a determination
under subparagraph (A) and until the Secretary is
satisfied that the basis for such determination has
been corrected and is not likely to recur.
The provisions of section 1128A (other than subsections (a) and
(b)) shall apply to a civil money penalty under clause (i) in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A(a).
(6)(A) For purposes of this subsection and section
1902(e)(2)(A), in the case of the State of New Jersey, the term
``contract'' shall be deemed to include an undertaking by the
State agency, in the State plan under this title, to operate a
program meeting all requirements of this subsection.
(B) The undertaking described in subparagraph (A) must
provide--
(i) for the establishment of a separate entity
responsible for the operation of a program meeting the
requirements of this subsection, which entity may be a
subdivision of the State agency administering the State
plan under this title;
(ii) for separate accounting for the funds used to
operate such program; and
(iii) for setting the capitation rates and any other
payment rates for services provided in accordance with
this subsection using a methodology satisfactory to the
Secretary designed to ensure that total Federal
matching payments under this title for such services
will be lower than the matching payments that would be
made for the same services, if provided under the State
plan on a fee for service basis to an actuarially
equivalent population.
(C) The undertaking described in subparagraph (A) shall be
subject to approval (and annual re-approval) by the Secretary
in the same manner as a contract under this subsection.
(D) The undertaking described in subparagraph (A) shall not
be eligible for a waiver under section 1915(b).
(7) Payment shall be made under this title to a State for
expenditures for capitation payments described in section
438.6(e) of title 42, Code of Federal Regulations (or any
successor regulation).
(8)(A) The State agency administering the State plan under
this title may have reasonable access, as determined by the
State, to 1 or more prescription drug monitoring program
databases administered or accessed by the State to the extent
the State agency is permitted to access such databases under
State law.
(B) Such State agency may facilitate reasonable access, as
determined by the State, to 1 or more prescription drug
monitoring program databases administered or accessed by the
State, to same extent that the State agency is permitted under
State law to access such databases, for--
(i) any provider enrolled under the State plan to
provide services to Medicaid beneficiaries; and
(ii) any managed care entity (as defined under
section 1932(a)(1)(B)) that has a contract with the
State under this subsection or under section
1905(t)(3).
(C) Such State agency may share information in such
databases, to the same extent that the State agency is
permitted under State law to share information in such
databases, with--
(i) any provider enrolled under the State plan to
provide services to Medicaid beneficiaries; and
(ii) any managed care entity (as defined under
section 1932(a)(1)(B)) that has a contract with the
State under this subsection or under section
1905(t)(3).
(9)(A) With respect to expenditures described in subparagraph
(B) that are incurred by a State for any fiscal year after
fiscal year 2020 (and before fiscal year 2024), in determining
the pro rata share to which the United States is equitably
entitled under subsection (d)(3), the Secretary shall
substitute the Federal medical assistance percentage that
applies for such fiscal year to the State under section 1905(b)
(without regard to any adjustments to such percentage
applicable under such section or any other provision of law)
for the percentage that applies to such expenditures under
section 1905(y).
(B) Expenditures described in this subparagraph, with respect
to a fiscal year to which subparagraph (A) applies, are
expenditures incurred by a State for payment for medical
assistance provided to individuals described in subclause
(VIII) of section 1902(a)(10)(A)(i) by a managed care entity,
or other specified entity (as defined in subparagraph
(D)(iii)), that are treated as remittances because the State--
(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
(I) in the case of a State described in
subparagraph (C), to apply a minimum medical
loss ratio (as defined in subparagraph (D)(ii))
that is at least 85 percent but not greater
than the minimum medical loss ratio (as so
defined) that such State applied as of May 31,
2018; or
(II) in the case of a State not described in
subparagraph (C), to apply a minimum medical
loss ratio that is equal to 85 percent; and
(ii) recovered all or a portion of the expenditures
as a result of the entity's failure to meet such ratio.
(C) For purposes of subparagraph (B), a State described in
this subparagraph is a State that as of May 31, 2018, applied a
minimum medical loss ratio (as calculated under subsection (d)
of section 438.8 of title 42, Code of Federal Regulations (as
in effect on June 1, 2018)) for payment for services provided
by entities described in such subparagraph under the State plan
under this title (or a waiver of the plan) that is equal to or
greater than 85 percent.
(D) For purposes of this paragraph:
(i) The term ``managed care entity'' means a medicaid
managed care organization described in section
1932(a)(1)(B)(i).
(ii) The term ``minimum medical loss ratio'' means,
with respect to a State, a minimum medical loss ratio
(as calculated under subsection (d) of section 438.8 of
title 42, Code of Federal Regulations (as in effect on
June 1, 2018)) for payment for services provided by
entities described in subparagraph (B) under the State
plan under this title (or a waiver of the plan).
(iii) The term ``other specified entity'' means--
(I) a prepaid inpatient health plan, as
defined in section 438.2 of title 42, Code of
Federal Regulations (or any successor
regulation); and
(II) a prepaid ambulatory health plan, as
defined in such section (or any successor
regulation).
(o) Notwithstanding the preceding provisions of this section,
no payment shall be made to a State under the preceding
provisions of this section for expenditures for medical
assistance provided for an individual under its State plan
approved under this title to the extent that a private insurer
(as defined by the Secretary by regulation and including a
group health plan (as defined in section 607(1) of the Employee
Retirement Income Security Act of 1974), a service benefit
plan, and a health maintenance organization) would have been
obligated to provide such assistance but for a provision of its
insurance contract which has the effect of limiting or
excluding such obligation because the individual is eligible
for or is provided medical assistance under the plan.
(p)(1) When a political subdivision of a State makes, for the
State of which it is a political subdivision, or one State
makes, for another State, the enforcement and collection of
rights of support or payment assigned under section 1912,
pursuant to a cooperative arrangement under such section
(either within or outside of such State), there shall be paid
to such political subdivision or such other State from amounts
which would otherwise represent the Federal share of payments
for medical assistance provided to the eligible individuals on
whose behalf such enforcement and collection was made, an
amount equal to 15 percent of any amount collected which is
attributable to such rights of support or payment.
(2) Where more than one jurisdiction is involved in such
enforcement or collection, the amount of the incentive payment
determined under paragraph (1) shall be allocated among the
jurisdictions in a manner to be prescribed by the Secretary.
(q) For the purposes of this section, the term ``State
medicaid fraud control unit'' means a single identifiable
entity of the State government which the Secretary certifies
(and annually recertifies) as meeting the following
requirements:
(1) The entity (A) is a unit of the office of the
State Attorney General or of another department of
State government which possesses statewide authority to
prosecute individuals for criminal violations, (B) is
in a State the constitution of which does not provide
for the criminal prosecution of individuals by a
statewide authority and has formal procedures, approved
by the Secretary, that (i) assure its referral of
suspected criminal violations relating to the program
under this title to the appropriate authority or
authorities in the State for prosecution and (ii)
assure its assistance of, and coordination with, such
authority or authorities in such prosecutions, or (C)
has a formal working relationship with the office of
the State Attorney General and has formal procedures
(including procedures for its referral of suspected
criminal violations to such office) which are approved
by the Secretary and which provide effective
coordination of activities between the entity and such
office with respect to the detection, investigation,
and prosecution of suspected criminal violations
relating to the program under this title.
(2) The entity is separate and distinct from the
single State agency that administers or supervises the
administration of the State plan under this title.
(3) The entity's function is conducting a statewide
program for the investigation and prosecution of
violations of all applicable State laws regarding any
and all aspects of fraud in connection with (A) any
aspect of the provision of medical assistance and the
activities of providers of such assistance under the
State plan under this title; and (B) upon the approval
of the Inspector General of the relevant Federal
agency, any aspect of the provision of health care
services and activities of providers of such services
under any Federal health care program (as defined in
section 1128B(f)(1)), if the suspected fraud or
violation of law in such case or investigation is
primarily related to the State plan under this title.
(4)(A) The entity has--
(i) procedures for reviewing complaints of
abuse or neglect of patients in health care
facilities which receive payments under the
State plan under this title;
(ii) at the option of the entity, procedures
for reviewing complaints of abuse or neglect of
patients residing in board and care facilities
and of patients (who are receiving medical
assistance under the State plan under this
title (or waiver of such plan)) in a
noninstitutional or other setting; and
(iii) procedures for acting upon such
complaints under the criminal laws of the State
or for referring such complaints to other State
agencies for action.
(B) For purposes of this paragraph, the term ``board
and care facility'' means a residential setting which
receives payment (regardless of whether such payment is
made under the State plan under this title) from or on
behalf of two or more unrelated adults who reside in
such facility, and for whom one or both of the
following is provided:
(i) Nursing care services provided by, or
under the supervision of, a registered nurse,
licensed practical nurse, or licensed nursing
assistant.
(ii) A substantial amount of personal care
services that assist residents with the
activities of daily living, including personal
hygiene, dressing, bathing, eating, toileting,
ambulation, transfer, positioning, self-
medication, body care, travel to medical
services, essential shopping, meal preparation,
laundry, and housework.
(5) The entity provides for the collection, or
referral for collection to a single State agency, of
overpayments that are made under the State plan or
under any Federal health care program (as so defined)
to health care facilities and that are discovered by
the entity in carrying out its activities. All funds
collected in accordance with this paragraph shall be
credited exclusively to, and available for expenditure
under, the Federal health care program (including the
State plan under this title) that was subject to the
activity that was the basis for the collection.
(6) The entity employs such auditors, attorneys,
investigators, and other necessary personnel and is
organized in such a manner as is necessary to promote
the effective and efficient conduct of the entity's
activities.
(7) The entity submits to the Secretary an
application and annual reports containing such
information as the Secretary determines, by regulation,
to be necessary to determine whether the entity meets
the other requirements of this subsection.
(r)(1) In order to receive payments under subsection (a) for
use of automated data systems in administration of the State
plan under this title, a State must, in addition to meeting the
requirements of paragraph (3), have in operation mechanized
claims processing and information retrieval systems that meet
the requirements of this subsection and that the Secretary has
found--
(A) are adequate to provide efficient, economical,
and effective administration of such State plan;
(B) are compatible with the claims processing and
information retrieval systems used in the
administration of title XVIII, and for this purpose--
(i) have a uniform identification coding
system for providers, other payees, and
beneficiaries under this title or title XVIII;
(ii) provide liaison between States and
carriers and intermediaries with agreements
under title XVIII to facilitate timely exchange
of appropriate data;
(iii) provide for exchange of data between
the States and the Secretary with respect to
persons sanctioned under this title or title
XVIII; and
(iv) effective for claims filed on or after
October 1, 2010, incorporate compatible
methodologies of the National Correct Coding
Initiative administered by the Secretary (or
any successor initiative to promote correct
coding and to control improper coding leading
to inappropriate payment) and such other
methodologies of that Initiative (or such other
national correct coding methodologies) as the
Secretary identifies in accordance with
paragraph (4);
(C) are capable of providing accurate and timely
data;
(D) are complying with the applicable provisions of
part C of title XI;
(E) are designed to receive provider claims in
standard formats to the extent specified by the
Secretary; and
(F) effective for claims filed on or after January 1,
1999, provide for electronic transmission of claims
data in the format specified by the Secretary and
consistent with the Medicaid Statistical Information
System (MSIS) (including detailed individual enrollee
encounter data and other information that the Secretary
may find necessary and including, for data submitted to
the Secretary on or after January 1, 2010, data
elements from the automated data system that the
Secretary determines to be necessary for program
integrity, program oversight, and administration, at
such frequency as the Secretary shall determine).
(2) In order to meet the requirements of this paragraph,
mechanized claims processing and information retrieval systems
must meet the following requirements:
(A) The systems must be capable of developing
provider, physician, and patient profiles which are
sufficient to provide specific information as to the
use of covered types of services and items, including
prescribed drugs.
(B) The State must provide that information on
probable fraud or abuse which is obtained from, or
developed by, the systems, is made available to the
State's medicaid fraud control unit (if any) certified
under subsection (q) of this section.
(C) The systems must meet all performance standards
and other requirements for initial approval developed
by the Secretary.
(3) In order to meet the requirements of this paragraph, a
State must have in operation an eligibility determination
system which provides for data matching through the Public
Assistance Reporting Information System (PARIS) facilitated by
the Secretary (or any successor system), including matching
with medical assistance programs operated by other States.
(4) For purposes of paragraph (1)(B)(iv), the Secretary shall
do the following:
(A) Not later than September 1, 2010:
(i) Identify those methodologies of the
National Correct Coding Initiative administered
by the Secretary (or any successor initiative
to promote correct coding and to control
improper coding leading to inappropriate
payment) which are compatible to claims filed
under this title.
(ii) Identify those methodologies of such
Initiative (or such other national correct
coding methodologies) that should be
incorporated into claims filed under this title
with respect to items or services for which
States provide medical assistance under this
title and no national correct coding
methodologies have been established under such
Initiative with respect to title XVIII.
(iii) Notify States of--
(I) the methodologies identified
under subparagraphs (A) and (B) (and of
any other national correct coding
methodologies identified under
subparagraph (B)); and
(II) how States are to incorporate
such methodologies into claims filed
under this title.
(B) Not later than March 1, 2011, submit a report to
Congress that includes the notice to States under
clause (iii) of subparagraph (A) and an analysis
supporting the identification of the methodologies made
under clauses (i) and (ii) of subparagraph (A).
(s) Notwithstanding the preceding provisions of this section,
no payment shall be made to a State under this section for
expenditures for medical assistance under the State plan
consisting of a designated health service (as defined in
subsection (h)(6) of section 1877) furnished to an individual
on the basis of a referral that would result in the denial of
payment for the service under title XVIII if such title
provided for coverage of such service to the same extent and
under the same terms and conditions as under the State plan,
and subsections (f) and (g)(5) of such section shall apply to a
provider of such a designated health service for which payment
may be made under this title in the same manner as such
subsections apply to a provider of such a service for which
payment may be made under such title.
(t)(1) For purposes of subsection (a)(3)(F), the payments
described in this paragraph to encourage the adoption and use
of certified EHR technology are payments made by the State in
accordance with this subsection --
(A) to Medicaid providers described in paragraph
(2)(A) not in excess of 85 percent of net average
allowable costs (as defined in paragraph (3)(E)) for
certified EHR technology (and support services
including maintenance and training that is for, or is
necessary for the adoption and operation of, such
technology) with respect to such providers; and
(B) to Medicaid providers described in paragraph
(2)(B) not in excess of the maximum amount permitted
under paragraph (5) for the provider involved.
(2) In this subsection and subsection (a)(3)(F), the term
``Medicaid provider'' means--
(A) an eligible professional (as defined in paragraph
(3)(B))--
(i) who is not hospital-based and has at
least 30 percent of the professional's patient
volume (as estimated in accordance with a
methodology established by the Secretary)
attributable to individuals who are receiving
medical assistance under this title;
(ii) who is not described in clause (i), who
is a pediatrician, who is not hospital-based,
and who has at least 20 percent of the
professional's patient volume (as estimated in
accordance with a methodology established by
the Secretary) attributable to individuals who
are receiving medical assistance under this
title; and
(iii) who practices predominantly in a
Federally qualified health center or rural
health clinic and has at least 30 percent of
the professional's patient volume (as estimated
in accordance with a methodology established by
the Secretary) attributable to needy
individuals (as defined in paragraph (3)(F));
and
(B)(i) a children's hospital, or
(ii) an acute-care hospital that is not described in
clause (i) and that has at least 10 percent of the
hospital's patient volume (as estimated in accordance
with a methodology established by the Secretary)
attributable to individuals who are receiving medical
assistance under this title.
An eligible professional shall not qualify as a Medicaid
provider under this subsection unless any right to payment
under sections 1848(o) and 1853(l) with respect to the eligible
professional has been waived in a manner specified by the
Secretary. For purposes of calculating patient volume under
subparagraph (A)(iii), insofar as it is related to
uncompensated care, the Secretary may require the adjustment of
such uncompensated care data so that it would be an appropriate
proxy for charity care, including a downward adjustment to
eliminate bad debt data from uncompensated care. In applying
subparagraphs (A) and (B)(ii), the methodology established by
the Secretary for patient volume shall include individuals
enrolled in a Medicaid managed care plan (under section 1903(m)
or section 1932).
(3) In this subsection and subsection (a)(3)(F):
(A) The term ``certified EHR technology'' means a
qualified electronic health record (as defined in
3000(13) of the Public Health Service Act) that is
certified pursuant to section 3001(c)(5) of such Act as
meeting standards adopted under section 3004 of such
Act that are applicable to the type of record involved
(as determined by the Secretary, such as an ambulatory
electronic health record for office-based physicians or
an inpatient hospital electronic health record for
hospitals).
(B) The term ``eligible professional'' means a--
(i) physician;
(ii) dentist;
(iii) certified nurse mid-wife;
(iv) nurse practitioner; and
(v) physician assistant insofar as the
assistant is practicing in a rural health
clinic that is led by a physician assistant or
is practicing in a Federally qualified health
center that is so led.
(C) The term ``average allowable costs'' means, with
respect to certified EHR technology of Medicaid
providers described in paragraph (2)(A) for--
(i) the first year of payment with respect to
such a provider, the average costs for the
purchase and initial implementation or upgrade
of such technology (and support services
including training that is for, or is necessary
for the adoption and initial operation of, such
technology) for such providers, as determined
by the Secretary based upon studies conducted
under paragraph (4)(C); and
(ii) a subsequent year of payment with
respect to such a provider, the average costs
not described in clause (i) relating to the
operation, maintenance, and use of such
technology for such providers, as determined by
the Secretary based upon studies conducted
under paragraph (4)(C).
(D) The term ``hospital-based'' means, with respect
to an eligible professional, a professional (such as a
pathologist, anesthesiologist, or emergency physician)
who furnishes substantially all of the individual's
professional services in a hospital inpatient or
emergency room setting and through the use of the
facilities and equipment, including qualified
electronic health records, of the hospital. The
determination of whether an eligible professional is a
hospital-based eligible professional shall be made on
the basis of the site of service (as defined by the
Secretary) and without regard to any employment or
billing arrangement between the eligible professional
and any other provider.
(E) The term ``net average allowable costs'' means,
with respect to a Medicaid provider described in
paragraph (2)(A), average allowable costs reduced by
the average payment the Secretary estimates will be
made to such Medicaid providers (determined on a
percentage or other basis for such classes or types of
providers as the Secretary may specify) from other
sources (other than under this subsection, or by the
Federal government or a State or local government) that
is directly attributable to payment for certified EHR
technology or support services described in
subparagraph (C).
(F) The term ``needy individual'' means, with respect
to a Medicaid provider, an individual--
(i) who is receiving assistance under this
title;
(ii) who is receiving assistance under title
XXI;
(iii) who is furnished uncompensated care by
the provider; or
(iv) for whom charges are reduced by the
provider on a sliding scale basis based on an
individual's ability to pay.
(4)(A) With respect to a Medicaid provider described in
paragraph (2)(A), subject to subparagraph (B), in no case
shall--
(i) the net average allowable costs under
this subsection for the first year of payment
(which may not be later than 2016), which is
intended to cover the costs described in
paragraph (3)(C)(i), exceed $25,000 (or such
lesser amount as the Secretary determines based
on studies conducted under subparagraph (C));
(ii) the net average allowable costs under
this subsection for a subsequent year of
payment, which is intended to cover costs
described in paragraph (3)(C)(ii), exceed
$10,000; and
(iii) payments be made for costs described in
clause (ii) after 2021 or over a period of
longer than 5 years.
(B) In the case of Medicaid provider described in paragraph
(2)(A)(ii), the dollar amounts specified in subparagraph (A)
shall be \2/3\ of the dollar amounts otherwise specified.
(C) For the purposes of determining average allowable costs
under this subsection, the Secretary shall study the average
costs to Medicaid providers described in paragraph (2)(A) of
purchase and initial implementation and upgrade of certified
EHR technology described in paragraph (3)(C)(i) and the average
costs to such providers of operations, maintenance, and use of
such technology described in paragraph (3)(C)(ii). In
determining such costs for such providers, the Secretary may
utilize studies of such amounts submitted by States.
(5)(A) In no case shall the payments described in paragraph
(1)(B) with respect to a Medicaid provider described in
paragraph (2)(B) exceed--
(i) in the aggregate the product of--
(I) the overall hospital EHR amount
for the provider computed under
subparagraph (B); and
(II) the Medicaid share for such
provider computed under subparagraph
(C);
(ii) in any year 50 percent of the product described
in clause (i); and
(iii) in any 2-year period 90 percent of such
product.
(B) For purposes of this paragraph, the overall hospital EHR
amount, with respect to a Medicaid provider, is the sum of the
applicable amounts specified in section 1886(n)(2)(A) for such
provider for the first 4 payment years (as estimated by the
Secretary) determined as if the Medicare share specified in
clause (ii) of such section were 1. The Secretary shall
establish, in consultation with the State, the overall hospital
EHR amount for each such Medicaid provider eligible for
payments under paragraph (1)(B). For purposes of this
subparagraph in computing the amounts under section
1886(n)(2)(C) for payment years after the first payment year,
the Secretary shall assume that in subsequent payment years
discharges increase at the average annual rate of growth of the
most recent 3 years for which discharge data are available per
year.
(C) The Medicaid share computed under this subparagraph, for
a Medicaid provider for a period specified by the Secretary,
shall be calculated in the same manner as the Medicare share
under section 1886(n)(2)(D) for such a hospital and period,
except that there shall be substituted for the numerator under
clause (i) of such section the amount that is equal to the
number of inpatient-bed-days (as established by the Secretary)
which are attributable to individuals who are receiving medical
assistance under this title and who are not described in
section 1886(n)(2)(D)(i). In computing inpatient-bed-days under
the previous sentence, the Secretary shall take into account
inpatient-bed-days attributable to inpatient-bed-days that are
paid for individuals enrolled in a Medicaid managed care plan
(under section 1903(m) or section 1932).
(D) In no case may the payments described in paragraph (1)(B)
with respect to a Medicaid provider described in paragraph
(2)(B) be paid--
(i) for any year beginning after 2016 unless the
provider has been provided payment under paragraph
(1)(B) for the previous year; and
(ii) over a period of more than 6 years of payment.
(6) Payments described in paragraph (1) are not in accordance
with this subsection unless the following requirements are met:
(A)(i) The State provides assurances satisfactory to
the Secretary that amounts received under subsection
(a)(3)(F) with respect to payments to a Medicaid
provider are paid, subject to clause (ii), directly to
such provider (or to an employer or facility to which
such provider has assigned payments) without any
deduction or rebate.
(ii) Amounts described in clause (i) may also be paid
to an entity promoting the adoption of certified EHR
technology, as designated by the State, if
participation in such a payment arrangement is
voluntary for the eligible professional involved and if
such entity does not retain more than 5 percent of such
payments for costs not related to certified EHR
technology (and support services including maintenance
and training) that is for, or is necessary for the
operation of, such technology.
(B) A Medicaid provider described in paragraph (2)(A)
is responsible for payment of the remaining 15 percent
of the net average allowable cost and shall be
determined to have met such responsibility to the
extent that the payment to the Medicaid provider is not
in excess of 85 percent of the net average allowable
cost.
(C)(i) Subject to clause (ii), with respect to
payments to a Medicaid provider--
(I) for the first year of payment to the
Medicaid provider under this subsection, the
Medicaid provider demonstrates that it is
engaged in efforts to adopt, implement, or
upgrade certified EHR technology; and
(II) for a year of payment, other than the
first year of payment to the Medicaid provider
under this subsection, the Medicaid provider
demonstrates meaningful use of certified EHR
technology through a means that is approved by
the State and acceptable to the Secretary, and
that may be based upon the methodologies
applied under section 1848(o) or 1886(n).
(ii) In the case of a Medicaid provider who has
completed adopting, implementing, or upgrading such
technology prior to the first year of payment to the
Medicaid provider under this subsection, clause (i)(I)
shall not apply and clause (i)(II) shall apply to each
year of payment to the Medicaid provider under this
subsection, including the first year of payment.
(D) To the extent specified by the Secretary, the
certified EHR technology is compatible with State or
Federal administrative management systems.
For purposes of subparagraph (B), a Medicaid provider described
in paragraph (2)(A) may accept payments for the costs described
in such subparagraph from a State or local government. For
purposes of subparagraph (C), in establishing the means
described in such subparagraph, which may include clinical
quality reporting to the State, the State shall ensure that
populations with unique needs, such as children, are
appropriately addressed.
(7) With respect to Medicaid providers described in paragraph
(2)(A), the Secretary shall ensure coordination of payment with
respect to such providers under sections 1848(o) and 1853(l)
and under this subsection to assure no duplication of funding.
Such coordination shall include, to the extent practicable, a
data matching process between State Medicaid agencies and the
Centers for Medicare & Medicaid Services using national
provider identifiers. For such purposes, the Secretary may
require the submission of such data relating to payments to
such Medicaid providers as the Secretary may specify.
(8) In carrying out paragraph (6)(C), the State and Secretary
shall seek, to the maximum extent practicable, to avoid
duplicative requirements from Federal and State governments to
demonstrate meaningful use of certified EHR technology under
this title and title XVIII. In doing so, the Secretary may deem
satisfaction of requirements for such meaningful use for a
payment year under title XVIII to be sufficient to qualify as
meaningful use under this subsection. The Secretary may also
specify the reporting periods under this subsection in order to
carry out this paragraph.
(9) In order to be provided Federal financial participation
under subsection (a)(3)(F)(ii), a State must demonstrate to the
satisfaction of the Secretary, that the State--
(A) is using the funds provided for the purposes of
administering payments under this subsection, including
tracking of meaningful use by Medicaid providers;
(B) is conducting adequate oversight of the program
under this subsection, including routine tracking of
meaningful use attestations and reporting mechanisms;
and
(C) is pursuing initiatives to encourage the adoption
of certified EHR technology to promote health care
quality and the exchange of health care information
under this title, subject to applicable laws and
regulations governing such exchange.
(10) The Secretary shall periodically submit reports to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Finance of the Senate on
status, progress, and oversight of payments described in
paragraph (1), including steps taken to carry out paragraph
(7). Such reports shall also describe the extent of adoption of
certified EHR technology among Medicaid providers resulting
from the provisions of this subsection and any improvements in
health outcomes, clinical quality, or efficiency resulting from
such adoption.
(u)(1)(A) Notwithstanding subsection (a)(1), if the ratio of
a State's erroneous excess payments for medical assistance (as
defined in subparagraph (D)) to its total expenditures for
medical assistance under the State plan approved under this
title exceeds 0.03, for the period consisting of the third and
fourth quarters of fiscal year 1983, or for any full fiscal
year thereafter, then the Secretary shall make no payment for
such period or fiscal year with respect to so much of such
erroneous excess payments as exceeds such allowable error rate
of 0.03.
(B) The Secretary may waive, in certain limited cases, all or
part of the reduction required under subparagraph (A) with
respect to any State if such State is unable to reach the
allowable error rate for a period or fiscal year despite a good
faith effort by such State.
(C) In estimating the amount to be paid to a State under
subsection (d), the Secretary shall take into consideration the
limitation on Federal financial participation imposed by
subparagraph (A) and shall reduce the estimate he makes under
subsection (d)(1), for purposes of payment to the State under
subsection (d)(3), in light of any expected erroneous excess
payments for medical assistance (estimated in accordance with
such criteria, including sampling procedures, as he may
prescribe and subject to subsequent adjustment, if necessary,
under subsection (d)(2)).
(D)(i) For purposes of this subsection, the term ``erroneous
excess payments for medical assistance'' means the total of--
(I) payments under the State plan with respect to
ineligible individuals and families, and
(II) overpayments on behalf of eligible individuals
and families by reason of error in determining the
amount of expenditures for medical care required of an
individual or family as a condition of eligibility.
(ii) In determining the amount of erroneous excess payments
for medical assistance to an ineligible individual or family
under clause (i)(I), if such ineligibility is the result of an
error in determining the amount of the resources of such
individual or family, the amount of the erroneous excess
payment shall be the smaller of (I) the amount of the payment
with respect to such individual or family, or (II) the
difference between the actual amount of such resources and the
allowable resource level established under the State plan.
(iii) In determining the amount of erroneous excess payments
for medical assistance to an individual or family under clause
(i)(II), the amount of the erroneous excess payment shall be
the smaller of (I) the amount of the payment on behalf of the
individual or family, or (II) the difference between the actual
amount incurred for medical care by the individual or family
and the amount which should have been incurred in order to
establish eligibility for medical assistance.
(iv) In determining the amount of erroneous excess payments,
there shall not be included any error resulting from a failure
of an individual to cooperate or give correct information with
respect to third-party liability as required under section
1912(a)(1)(C) or 402(a)(26)(C) or with respect to payments made
in violation of section 1906.
(v) In determining the amount of erroneous excess payments,
there shall not be included any erroneous payments made for
ambulatory prenatal care provided during a presumptive
eligibility period (as defined in section 1920(b)(1)), for
items and services described in subsection (a) of section 1920A
provided to a child during a presumptive eligibility period
under such section, for medical assistance provided to an
individual described in subsection (a) of section 1920B during
a presumptive eligibility period under such section, or for
medical assistance provided to an individual during a
presumptive eligibility period resulting from a determination
of presumptive eligibility made by a hospital that elects under
section 1902(a)(47)(B) to be a qualified entity for such
purpose.
(E) For purposes of subparagraph (D), there shall be
excluded, in determining both erroneous excess payments for
medical assistance and total expenditures for medical
assistance--
(i) payments with respect to any individual whose
eligibility therefor was determined exclusively by the
Secretary under an agreement pursuant to section 1634
and such other classes of individuals as the Secretary
may by regulation prescribe whose eligibility was
determined in part under such an agreement; and
(ii) payments made as the result of a technical
error.
(2) The State agency administering the plan approved under
this title shall, at such times and in such form as the
Secretary may specify, provide information on the rates of
erroneous excess payments made (or expected, with respect to
future periods specified by the Secretary) in connection with
its administration of such plan, together with any other data
he requests that are reasonably necessary for him to carry out
the provisions of this subsection.
(3)(A) If a State fails to cooperate with the Secretary in
providing information necessary to carry out this subsection,
the Secretary, directly or through contractual or such other
arrangements as he may find appropriate, shall establish the
error rates for that State on the basis of the best data
reasonably available to him and in accordance with such
techniques for sampling and estimating as he finds appropriate.
(B) In any case in which it is necessary for the Secretary to
exercise his authority under subparagraph (A) to determine a
State's error rates for a fiscal year, the amount that would
otherwise be payable to such State under this title for
quarters in such year shall be reduced by the costs incurred by
the Secretary in making (directly or otherwise) such
determination.
(4) This subsection shall not apply with respect to Puerto
Rico, Guam, the Virgin Islands, the Northern Mariana Islands,
or American Samoa.
(v)(1) Notwithstanding the preceding provisions of this
section, except as provided in paragraphs (2) and (4), no
payment may be made to a State under this section for medical
assistance furnished to an alien who is not lawfully admitted
for permanent residence or otherwise permanently residing in
the United States under color of law.
(2) Payment shall be made under this section for care and
services that are furnished to an alien described in paragraph
(1) only if--
(A) such care and services are necessary for the
treatment of an emergency medical condition of the
alien,
(B) such alien otherwise meets the eligibility
requirements for medical assistance under the State
plan approved under this title (other than the
requirement of the receipt of aid or assistance under
title IV, supplemental security income benefits under
title XVI, or a State supplementary payment), and
(C) such care and services are not related to an
organ transplant procedure.
(3) For purposes of this subsection, the term ``emergency
medical condition'' means a medical condition (including
emergency labor and delivery) manifesting itself by acute
symptoms of sufficient severity (including severe pain) such
that the absence of immediate medical attention could
reasonably be expected to result in--
(A) placing the patient's health in serious jeopardy,
(B) serious impairment to bodily functions, or
(C) serious dysfunction of any bodily organ or part.
(4)(A) A State may elect (in a plan amendment under this
title) to provide medical assistance under this title,
notwithstanding sections 401(a), 402(b), 403, and 421 of the
Personal Responsibility and Work Opportunity Reconciliation Act
of 1996, to children and pregnant women who are lawfully
residing in the United States (including battered individuals
described in section 431(c) of such Act) and who are otherwise
eligible for such assistance, within either or both of the
following eligibility categories:
(i) Pregnant women.--Women during pregnancy (and
during the 60-day period beginning on the last day of
the pregnancy).
(ii) Children.--Individuals under 21 years of age,
including optional targeted low-income children
described in section 1905(u)(2)(B).
(B) In the case of a State that has elected to provide
medical assistance to a category of aliens under subparagraph
(A), no debt shall accrue under an affidavit of support against
any sponsor of such an alien on the basis of provision of
assistance to such category and the cost of such assistance
shall not be considered as an unreimbursed cost.
(C) As part of the State's ongoing eligibility
redetermination requirements and procedures for an individual
provided medical assistance as a result of an election by the
State under subparagraph (A), a State shall verify that the
individual continues to lawfully reside in the United States
using the documentation presented to the State by the
individual on initial enrollment. If the State cannot
successfully verify that the individual is lawfully residing in
the United States in this manner, it shall require that the
individual provide the State with further documentation or
other evidence to verify that the individual is lawfully
residing in the United States.
(w)(1)(A) Notwithstanding the previous provisions of this
section, for purposes of determining the amount to be paid to a
State (as defined in paragraph (7)(D)) under subsection (a)(1)
for quarters in any fiscal year, the total amount expended
during such fiscal year as medical assistance under the State
plan (as determined without regard to this subsection) shall be
reduced by the sum of any revenues received by the State (or by
a unit of local government in the State) during the fiscal
year--
(i) from provider-related donations (as defined in
paragraph (2)(A)), other than--
(I) bona fide provider-related donations (as
defined in paragraph (2)(B)), and
(II) donations described in paragraph (2)(C);
(ii) from health care related taxes (as defined in
paragraph (3)(A)), other than broad-based health care
related taxes (as defined in paragraph (3)(B));
(iii) from a broad-based health care related tax, if
there is in effect a hold harmless provision (described
in paragraph (4)) with respect to the tax; or
(iv) only with respect to State fiscal years (or
portions thereof) occurring on or after January 1,
1992, and before October 1, 1995, from broad-based
health care related taxes to the extent the amount of
such taxes collected exceeds the limit established
under paragraph (5).
(B) Notwithstanding the previous provisions of this section,
for purposes of determining the amount to be paid to a State
under subsection (a)(7) for all quarters in a Federal fiscal
year (beginning with fiscal year 1993), the total amount
expended during the fiscal year for administrative expenditures
under the State plan (as determined without regard to this
subsection) shall be reduced by the sum of any revenues
received by the State (or by a unit of local government in the
State) during such quarters from donations described in
paragraph (2)(C), to the extent the amount of such donations
exceeds 10 percent of the amounts expended under the State plan
under this title during the fiscal year for purposes described
in paragraphs (2), (3), (4), (6), and (7) of subsection (a).
(C)(i) Except as otherwise provided in clause (ii),
subparagraph (A)(i) shall apply to donations received on or
after January 1, 1992.
(ii) Subject to the limits described in clause (iii) and
subparagraph (E), subparagraph (A)(i) shall not apply to
donations received before the effective date specified in
subparagraph (F) if such donations are received under programs
in effect or as described in State plan amendments or related
documents submitted to the Secretary by September 30, 1991, and
applicable to State fiscal year 1992, as demonstrated by State
plan amendments, written agreements, State budget
documentation, or other documentary evidence in existence on
that date.
(iii) In applying clause (ii) in the case of donations
received in State fiscal year 1993, the maximum amount of such
donations to which such clause may be applied may not exceed
the total amount of such donations received in the
corresponding period in State fiscal year 1992 (or not later
than 5 days after the last day of the corresponding period).
(D)(i) Except as otherwise provided in clause (ii),
subparagraphs (A)(ii) and (A)(iii) shall apply to taxes
received on or after January 1, 1992.
(ii) Subparagraphs (A)(ii) and (A)(iii) shall not apply to
impermissible taxes (as defined in clause (iii)) received
before the effective date specified in subparagraph (F) to the
extent the taxes (including the tax rate or base) were in
effect, or the legislation or regulations imposing such taxes
were enacted or adopted, as of November 22, 1991.
(iii) In this subparagraph and subparagraph (E), the term
``impermissible tax'' means a health care related tax for which
a reduction may be made under clause (ii) or (iii) of
subparagraph (A).
(E)(i) In no case may the total amount of donations and taxes
permitted under the exception provided in subparagraphs (C)(ii)
and (D)(ii) for the portion of State fiscal year 1992 occurring
during calendar year 1992 exceed the limit under paragraph (5)
minus the total amount of broad-based health care related taxes
received in the portion of that fiscal year.
(ii) In no case may the total amount of donations and taxes
permitted under the exception provided in subparagraphs (C)(ii)
and (D)(ii) for State fiscal year 1993 exceed the limit under
paragraph (5) minus the total amount of broad-based health care
related taxes received in that fiscal year.
(F) In this paragraph in the case of a State--
(i) except as provided in clause (iii), with a State
fiscal year beginning on or before July 1, the
effective date is October 1, 1992,
(ii) except as provided in clause (iii), with a State
fiscal year that begins after July 1, the effective
date is January 1, 1993, or
(iii) with a State legislature which is not scheduled
to have a regular legislative session in 1992, with a
State legislature which is not scheduled to have a
regular legislative session in 1993, or with a
provider-specific tax enacted on November 4, 1991, the
effective date is July 1, 1993.
(2)(A) In this subsection (except as provided in paragraph
(6)), the term ``provider-related donation'' means any donation
or other voluntary payment (whether in cash or in kind) made
(directly or indirectly) to a State or unit of local government
by--
(i) a health care provider (as defined in paragraph
(7)(B)),
(ii) an entity related to a health care provider (as
defined in paragraph (7)(C)), or
(iii) an entity providing goods or services under the
State plan for which payment is made to the State under
paragraph (2), (3), (4), (6), or (7) of subsection (a).
(B) For purposes of paragraph (1)(A)(i)(I), the term ``bona
fide provider-related donation'' means a provider-related
donation that has no direct or indirect relationship (as
determined by the Secretary) to payments made under this title
to that provider, to providers furnishing the same class of
items and services as that provider, or to any related entity,
as established by the State to the satisfaction of the
Secretary. The Secretary may by regulation specify types of
provider-related donations described in the previous sentence
that will be considered to be bona fide provider-related
donations.
(C) For purposes of paragraph (1)(A)(i)(II), donations
described in this subparagraph are funds expended by a
hospital, clinic, or similar entity for the direct cost
(including costs of training and of preparing and distributing
outreach materials) of State or local agency personnel who are
stationed at the hospital, clinic, or entity to determine the
eligibility of individuals for medical assistance under this
title and to provide outreach services to eligible or
potentially eligible individuals.
(3)(A) In this subsection (except as provided in paragraph
(6)), the term ``health care related tax'' means a tax (as
defined in paragraph (7)(F)) that--
(i) is related to health care items or services, or
to the provision of, the authority to provide, or
payment for, such items or services, or
(ii) is not limited to such items or services but
provides for treatment of individuals or entities that
are providing or paying for such items or services that
is different from the treatment provided to other
individuals or entities.
In applying clause (i), a tax is considered to relate to health
care items or services if at least 85 percent of the burden of
such tax falls on health care providers.
(B) In this subsection, the term ``broad-based health care
related tax'' means a health care related tax which is imposed
with respect to a class of health care items or services (as
described in paragraph (7)(A)) or with respect to providers of
such items or services and which, except as provided in
subparagraphs (D), (E), and (F)--
(i) is imposed at least with respect to all items or
services in the class furnished by all non-Federal,
nonpublic providers in the State (or, in the case of a
tax imposed by a unit of local government, the area
over which the unit has jurisdiction) or is imposed
with respect to all non-Federal, nonpublic providers in
the class; and
(ii) is imposed uniformly (in accordance with
subparagraph (C)).
(C)(i) Subject to clause (ii), for purposes of subparagraph
(B)(ii), a tax is considered to be imposed uniformly if--
(I) in the case of a tax consisting of a licensing
fee or similar tax on a class of health care items or
services (or providers of such items or services), the
amount of the tax imposed is the same for every
provider providing items or services within the class;
(II) in the case of a tax consisting of a licensing
fee or similar tax imposed on a class of health care
items or services (or providers of such services) on
the basis of the number of beds (licensed or otherwise)
of the provider, the amount of the tax is the same for
each bed of each provider of such items or services in
the class;
(III) in the case of a tax based on revenues or
receipts with respect to a class of items or services
(or providers of items or services) the tax is imposed
at a uniform rate for all items and services (or
providers of such items of services) in the class on
all the gross revenues or receipts, or net operating
revenues, relating to the provision of all such items
or services (or all such providers) in the State (or,
in the case of a tax imposed by a unit of local
government within the State, in the area over which the
unit has jurisdiction); or
(IV) in the case of any other tax, the State
establishes to the satisfaction of the Secretary that
the tax is imposed uniformly.
(ii) Subject to subparagraphs (D) and (E), a tax imposed with
respect to a class of health care items and services is not
considered to be imposed uniformly if the tax provides for any
credits, exclusions, or deductions which have as their purpose
or effect the return to providers of all or a portion of the
tax paid in a manner that is inconsistent with subclauses (I)
and (II) of subparagraph (E)(ii) or provides for a hold
harmless provision described in paragraph (4).
(D) A tax imposed with respect to a class of health care
items and services is considered to be imposed uniformly--
(i) notwithstanding that the tax is not imposed with
respect to items or services (or the providers thereof)
for which payment is made under a State plan under this
title or title XVIII, or
(ii) in the case of a tax described in subparagraph
(C)(i)(III), notwithstanding that the tax provides for
exclusion (in whole or in part) of revenues or receipts
from a State plan under this title or title XVIII.
(E)(i) A State may submit an application to the Secretary
requesting that the Secretary treat a tax as a broad-based
health care related tax, notwithstanding that the tax does not
apply to all health care items or services in class (or all
providers of such items and services), provides for a credit,
deduction, or exclusion, is not applied uniformly, or otherwise
does not meet the requirements of subparagraph (B) or (C).
Permissible waivers may include exemptions for rural or sole-
community providers.
(ii) The Secretary shall approve such an application if the
State establishes to the satisfaction of the Secretary that--
(I) the net impact of the tax and associated
expenditures under this title as proposed by the State
is generally redistributive in nature, and
(II) the amount of the tax is not directly correlated
to payments under this title for items or services with
respect to which the tax is imposed.
The Secretary shall by regulation specify types of credits,
exclusions, and deductions that will be considered to meet the
requirements of this subparagraph.
(F) In no case shall a tax not qualify as a broad-based
health care related tax under this paragraph because it does
not apply to a hospital that is described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from taxation
under section 501(a) of such Code and that does not accept
payment under the State plan under this title or under title
XVIII.
(4) For purposes of paragraph (1)(A)(iii), there is in effect
a hold harmless provision with respect to a broad-based health
care related tax imposed with respect to a class of items or
services if the Secretary determines that any of the following
applies:
(A) The State or other unit of government imposing
the tax provides (directly or indirectly) for a payment
(other than under this title) to taxpayers and the
amount of such payment is positively correlated either
to the amount of such tax or to the difference between
the amount of the tax and the amount of payment under
the State plan.
(B) All or any portion of the payment made under this
title to the taxpayer varies based only upon the amount
of the total tax paid.
(C)(i) The State or other unit of government imposing
the tax provides (directly or indirectly) for any
payment, offset, or waiver that guarantees to hold
taxpayers harmless for any portion of the costs of the
tax.
(ii) For purposes of clause (i), a determination of
the existence of an indirect guarantee shall be made
under paragraph (3)(i) of section 433.68(f) of title
42, Code of Federal Regulations, as in effect on
November 1, 2006, except that for portions of fiscal
years beginning on or after January 1, 2008, and before
October 1, 2011, ``5.5 percent'' shall be substituted
for ``6 percent'' each place it appears.
The provisions of this paragraph shall not prevent use of the
tax to reimburse health care providers in a class for
expenditures under this title nor preclude States from relying
on such reimbursement to justify or explain the tax in the
legislative process.
(5)(A) For purposes of this subsection, the limit under this
subparagraph with respect to a State is an amount equal to 25
percent (or, if greater, the State base percentage, as defined
in subparagraph (B)) of the non-Federal share of the total
amount expended under the State plan during a State fiscal year
(or portion thereof), as it would be determined pursuant to
paragraph (1)(A) without regard to paragraph (1)(A)(iv).
(B)(i) In subparagraph (A), the term ``State base
percentage'' means, with respect to a State, an amount
(expressed as a percentage) equal to--
(I) the total of the amount of health care related
taxes (whether or not broad-based) and the amount of
provider-related donations (whether or not bona fide)
projected to be collected (in accordance with clause
(ii)) during State fiscal year 1992, divided by
(II) the non-Federal share of the total amount
estimated to be expended under the State plan during
such State fiscal year.
(ii) For purposes of clause (i)(I), in the case of a tax that
is not in effect throughout State fiscal year 1992 or the rate
(or base) of which is increased during such fiscal year, the
Secretary shall project the amount to be collected during such
fiscal year as if the tax (or increase) were in effect during
the entire State fiscal year.
(C)(i) The total amount of health care related taxes under
subparagraph (B)(i)(I) shall be determined by the Secretary
based on only those taxes (including the tax rate or base)
which were in effect, or for which legislation or regulations
imposing such taxes were enacted or adopted, as of November 22,
1991.
(ii) The amount of provider-related donations under
subparagraph (B)(i)(I) shall be determined by the Secretary
based on programs in effect on September 30, 1991, and
applicable to State fiscal year 1992, as demonstrated by State
plan amendments, written agreements, State budget
documentation, or other documentary evidence in existence on
that date.
(iii) The amount of expenditures described in subparagraph
(B)(i)(II) shall be determined by the Secretary based on the
best data available as of the date of the enactment of this
subsection.
(6)(A) Notwithstanding the provisions of this subsection, the
Secretary may not restrict States' use of funds where such
funds are derived from State or local taxes (or funds
appropriated to State university teaching hospitals)
transferred from or certified by units of government within a
State as the non-Federal share of expenditures under this
title, regardless of whether the unit of government is also a
health care provider, except as provided in section 1902(a)(2),
unless the transferred funds are derived by the unit of
government from donations or taxes that would not otherwise be
recognized as the non-Federal share under this section.
(B) For purposes of this subsection, funds the use of which
the Secretary may not restrict under subparagraph (A) shall not
be considered to be a provider-related donation or a health
care related tax.
(7) For purposes of this subsection:
(A) Each of the following shall be considered a
separate class of health care items and services:
(i) Inpatient hospital services.
(ii) Outpatient hospital services.
(iii) Nursing facility services (other than
services of intermediate care facilities for
the mentally retarded).
(iv) Services of intermediate care facilities
for the mentally retarded.
(v) Physicians' services.
(vi) Home health care services.
(vii) Outpatient prescription drugs.
(viii) Services of managed care organizations
(including health maintenance organizations,
preferred provider organizations, and such
other similar organizations as the Secretary
may specify by regulation).
(ix) Such other classification of health care
items and services consistent with this
subparagraph as the Secretary may establish by
regulation.
(B) The term ``health care provider'' means an
individual or person that receives payments for the
provision of health care items or services.
(C) An entity is considered to be ``related'' to a
health care provider if the entity--
(i) is an organization, association,
corporation or partnership formed by or on
behalf of health care providers;
(ii) is a person with an ownership or control
interest (as defined in section 1124(a)(3)) in
the provider;
(iii) is the employee, spouse, parent, child,
or sibling of the provider (or of a person
described in clause (ii)); or
(iv) has a similar, close relationship (as
defined in regulations) to the provider.
(D) The term ``State'' means only the 50 States and
the District of Columbia but does not include any State
whose entire program under this title is operated under
a waiver granted under section 1115.
(E) The ``State fiscal year'' means, with respect to
a specified year, a State fiscal year ending in that
specified year.
(F) The term ``tax'' includes any licensing fee,
assessment, or other mandatory payment, but does not
include payment of a criminal or civil fine or penalty
(other than a fine or penalty imposed in lieu of or
instead of a fee, assessment, or other mandatory
payment).
(G) The term ``unit of local government'' means, with
respect to a State, a city, county, special purpose
district, or other governmental unit in the State.
(x)(1) For purposes of section 1902(a)(46)(B)(i), the
requirement of this subsection is, with respect to an
individual declaring to be a citizen or national of the United
States, that, subject to paragraph (2), there is presented
satisfactory documentary evidence of citizenship or nationality
(as defined in paragraph (3)) of the individual.
(2) The requirement of paragraph (1) shall not apply to an
individual declaring to be a citizen or national of the United
States who is eligible for medical assistance under this
title--
(A) and is entitled to or enrolled for benefits under
any part of title XVIII;
(B) and is receiving--
(i) disability insurance benefits under
section 223 or monthly insurance benefits under
section 202 based on such individual's
disability (as defined in section 223(d)); or
(ii) supplemental security income benefits
under title XVI;
(C) and with respect to whom--
(i) child welfare services are made available
under part B of title IV on the basis of being
a child in foster care; or
(ii) adoption or foster care assistance is
made available under part E of title IV;
(D) pursuant to the application of section 1902(e)(4)
(and, in the case of an individual who is eligible for
medical assistance on such basis, the individual shall
be deemed to have provided satisfactory documentary
evidence of citizenship or nationality and shall not be
required to provide further documentary evidence on any
date that occurs during or after the period in which
the individual is eligible for medical assistance on
such basis); or
(E) on such basis as the Secretary may specify under
which satisfactory documentary evidence of citizenship
or nationality has been previously presented.
(3)(A) For purposes of this subsection, the term
``satisfactory documentary evidence of citizenship or
nationality'' means--
(i) any document described in subparagraph (B); or
(ii) a document described in subparagraph (C) and a
document described in subparagraph (D).
(B) The following are documents described in this
subparagraph:
(i) A United States passport.
(ii) Form N-550 or N-570 (Certificate of
Naturalization).
(iii) Form N-560 or N-561 (Certificate of United
States Citizenship).
(iv) A valid State-issued driver's license or other
identity document described in section 274A(b)(1)(D) of
the Immigration and Nationality Act, but only if the
State issuing the license or such document requires
proof of United States citizenship before issuance of
such license or document or obtains a social security
number from the applicant and verifies before
certification that such number is valid and assigned to
the applicant who is a citizen.
(v)(I) Except as provided in subclause (II), a
document issued by a federally recognized Indian tribe
evidencing membership or enrollment in, or affiliation
with, such tribe (such as a tribal enrollment card or
certificate of degree of Indian blood).
(II) With respect to those federally recognized
Indian tribes located within States having an
international border whose membership includes
individuals who are not citizens of the United States,
the Secretary shall, after consulting with such tribes,
issue regulations authorizing the presentation of such
other forms of documentation (including tribal
documentation, if appropriate) that the Secretary
determines to be satisfactory documentary evidence of
citizenship or nationality for purposes of satisfying
the requirement of this subsection.
(vi) Such other document as the Secretary may
specify, by regulation, that provides proof of United
States citizenship or nationality and that provides a
reliable means of documentation of personal identity.
(C) The following are documents described in this
subparagraph:
(i) A certificate of birth in the United States.
(ii) Form FS-545 or Form DS-1350 (Certification of
Birth Abroad).
(iii) Form I-197 (United States Citizen
Identification Card).
(iv) Form FS-240 (Report of Birth Abroad of a Citizen
of the United States).
(v) Such other document (not described in
subparagraph (B)(iv)) as the Secretary may specify that
provides proof of United States citizenship or
nationality.
(D) The following are documents described in this
subparagraph:
(i) Any identity document described in section
274A(b)(1)(D) of the Immigration and Nationality Act.
(ii) Any other documentation of personal identity of
such other type as the Secretary finds, by regulation,
provides a reliable means of identification.
(E) A reference in this paragraph to a form includes a
reference to any successor form.
(4) In the case of an individual declaring to be a citizen or
national of the United States with respect to whom a State
requires the presentation of satisfactory documentary evidence
of citizenship or nationality under section 1902(a)(46)(B)(i),
the individual shall be provided at least the reasonable
opportunity to present satisfactory documentary evidence of
citizenship or nationality under this subsection as is provided
under clauses (i) and (ii) of section 1137(d)(4)(A) to an
individual for the submittal to the State of evidence
indicating a satisfactory immigration status.
(5) Nothing in subparagraph (A) or (B) of section
1902(a)(46), the preceding paragraphs of this subsection, or
the Deficit Reduction Act of 2005, including section 6036 of
such Act, shall be construed as changing the requirement of
section 1902(e)(4) that a child born in the United States to an
alien mother for whom medical assistance for the delivery of
such child is available as treatment of an emergency medical
condition pursuant to subsection (v) shall be deemed eligible
for medical assistance during the first year of such child's
life.
(y) Payments for Establishment of Alternate Non-Emergency
Services Providers.--
(1) Payments.--In addition to the payments otherwise
provided under subsection (a), subject to paragraph
(2), the Secretary shall provide for payments to States
under such subsection for the establishment of
alternate non-emergency service providers (as defined
in section 1916A(e)(5)(B)), or networks of such
providers.
(2) Limitation.--The total amount of payments under
this subsection shall not exceed $50,000,000 during the
4-year period beginning with 2006. This subsection
constitutes budget authority in advance of
appropriations Acts and represents the obligation of
the Secretary to provide for the payment of amounts
provided under this subsection.
(3) Preference.--In providing for payments to States
under this subsection, the Secretary shall provide
preference to States that establish, or provide for,
alternate non-emergency services providers or networks
of such providers that--
(A) serve rural or underserved areas where
beneficiaries under this title may not have
regular access to providers of primary care
services; or
(B) are in partnership with local community
hospitals.
(4) Form and manner of payment.--Payment to a State
under this subsection shall be made only upon the
filing of such application in such form and in such
manner as the Secretary shall specify. Payment to a
State under this subsection shall be made in the same
manner as other payments under section 1903(a).
(z) Medicaid Transformation Payments.--
(1) In general.--In addition to the payments provided
under subsection (a), subject to paragraph (4), the
Secretary shall provide for payments to States for the
adoption of innovative methods to improve the
effectiveness and efficiency in providing medical
assistance under this title.
(2) Permissible uses of funds.--The following are
examples of innovative methods for which funds provided
under this subsection may be used:
(A) Methods for reducing patient error rates
through the implementation and use of
electronic health records, electronic clinical
decision support tools, or e-prescribing
programs.
(B) Methods for improving rates of collection
from estates of amounts owed under this title.
(C) Methods for reducing waste, fraud, and
abuse under the program under this title, such
as reducing improper payment rates as measured
by annual payment error rate measurement (PERM)
project rates.
(D) Implementation of a medication risk
management program as part of a drug use review
program under section 1927(g).
(E) Methods in reducing, in clinically
appropriate ways, expenditures under this title
for covered outpatient drugs, particularly in
the categories of greatest drug utilization, by
increasing the utilization of generic drugs
through the use of education programs and other
incentives to promote greater use of generic
drugs.
(F) Methods for improving access to primary
and specialty physician care for the uninsured
using integrated university-based hospital and
clinic systems.
(3) Application; terms and conditions.--
(A) In general.--No payments shall be made to
a State under this subsection unless the State
applies to the Secretary for such payments in a
form, manner, and time specified by the
Secretary.
(B) Terms and conditions.--Such payments are
made under such terms and conditions consistent
with this subsection as the Secretary
prescribes.
(C) Annual report.--Payment to a State under
this subsection is conditioned on the State
submitting to the Secretary an annual report on
the programs supported by such payment. Such
report shall include information on--
(i) the specific uses of such
payment;
(ii) an assessment of quality
improvements and clinical outcomes
under such programs; and
(iii) estimates of cost savings
resulting from such programs.
(4) Funding.--
(A) Limitation on funds.--The total amount of
payments under this subsection shall be equal
to, and shall not exceed--
(i) $75,000,000 for fiscal year 2007;
and
(ii) $75,000,000 for fiscal year
2008.
This subsection constitutes budget authority in
advance of appropriations Acts and represents
the obligation of the Secretary to provide for
the payment of amounts provided under this
subsection.
(B) Allocation of funds.--The Secretary shall
specify a method for allocating the funds made
available under this subsection among States.
Such method shall provide preference for States
that design programs that target health
providers that treat significant numbers of
Medicaid beneficiaries. Such method shall
provide that not less than 25 percent of such
funds shall be allocated among States the
population of which (as determined according to
data collected by the United States Census
Bureau) as of July 1, 2004, was more than 105
percent of the population of the respective
State (as so determined) as of April 1, 2000.
(C) Form and manner of payment.--Payment to a
State under this subsection shall be made in
the same manner as other payments under section
1903(a). There is no requirement for State
matching funds to receive payments under this
subsection.
(5) Medication risk management program.--
(A) In general.--For purposes of this
subsection, the term ``medication risk
management program'' means a program for
targeted beneficiaries that ensures that
covered outpatient drugs are appropriately used
to optimize therapeutic outcomes through
improved medication use and to reduce the risk
of adverse events.
(B) Elements.--Such program may include the
following elements:
(i) The use of established principles
and standards for drug utilization
review and best practices to analyze
prescription drug claims of targeted
beneficiaries and identify outlier
physicians.
(ii) On an ongoing basis provide
outlier physicians--
(I) a comprehensive pharmacy
claims history for each
targeted beneficiary under
their care;
(II) information regarding
the frequency and cost of
relapses and hospitalizations
of targeted beneficiaries under
the physician's care; and
(III) applicable best
practice guidelines and
empirical references.
(iii) Monitor outlier physician's
prescribing, such as failure to refill,
dosage strengths, and provide
incentives and information to encourage
the adoption of best clinical
practices.
(C) Targeted beneficiaries.--For purposes of
this paragraph, the term ``targeted
beneficiaries'' means Medicaid eligible
beneficiaries who are identified as having high
prescription drug costs and medical costs, such
as individuals with behavioral disorders or
multiple chronic diseases who are taking
multiple medications.
(aa) Demonstration Project To Increase Substance Use Provider
Capacity.--
(1) In general.--Not later than the date that is 180
days after the date of the enactment of this
subsection, the Secretary shall, in consultation, as
appropriate, with the Director of the Agency for
Healthcare Research and Quality and the Assistant
Secretary for Mental Health and Substance Use, conduct
a 54-month demonstration project for the purpose
described in paragraph (2) under which the Secretary
shall--
(A) for the first 18-month period of such
project, award planning grants described in
paragraph (3); and
(B) for the remaining 36-month period of such
project, provide to each State selected under
paragraph (4) payments in accordance with
paragraph (5).
(2) Purpose.--The purpose described in this paragraph
is for each State selected under paragraph (4) to
increase the treatment capacity of providers
participating under the State plan (or a waiver of such
plan) to provide substance use disorder treatment or
recovery services under such plan (or waiver) through
the following activities:
(A) For the purpose described in paragraph
(3)(C)(i), activities that support an ongoing
assessment of the behavioral health treatment
needs of the State, taking into account the
matters described in subclauses (I) through
(IV) of such paragraph.
(B) Activities that, taking into account the
results of the assessment described in
subparagraph (A), support the recruitment,
training, and provision of technical assistance
for providers participating under the State
plan (or a waiver of such plan) that offer
substance use disorder treatment or recovery
services.
(C) Improved reimbursement for and expansion
of, through the provision of education,
training, and technical assistance, the number
or treatment capacity of providers
participating under the State plan (or waiver)
that--
(i) are authorized to dispense drugs
approved by the Food and Drug
Administration for individuals with a
substance use disorder who need
withdrawal management or maintenance
treatment for such disorder; and
[(ii) have in effect a registration
or waiver under section 303(g) of the
Controlled Substances Act for purposes
of dispensing narcotic drugs to
individuals for maintenance treatment
or detoxification treatment and are in
compliance with any regulation
promulgated by the Assistant Secretary
for Mental Health and Substance Use for
purposes of carrying out the
requirements of such section 303(g);
and]
[(iii)] (ii) are qualified under
applicable State law to provide
substance use disorder treatment or
recovery services.
(D) Improved reimbursement for and expansion
of, through the provision of education,
training, and technical assistance, the number
or treatment capacity of providers
participating under the State plan (or waiver)
that have the qualifications to address the
treatment or recovery needs of--
(i) individuals enrolled under the
State plan (or a waiver of such plan)
who have neonatal abstinence syndrome,
in accordance with guidelines issued by
the American Academy of Pediatrics and
American College of Obstetricians and
Gynecologists relating to maternal care
and infant care with respect to
neonatal abstinence syndrome;
(ii) pregnant women, postpartum
women, and infants, particularly the
concurrent treatment, as appropriate,
and comprehensive case management of
pregnant women, post-partum women and
infants, enrolled under the State plan
(or a waiver of such plan);
(iii) adolescents and young adults
between the ages of 12 and 21 enrolled
under the State plan (or a waiver of
such plan); or
(iv) American Indian and Alaska
Native individuals enrolled under the
State plan (or a waiver of such plan).
(3) Planning grants.--
(A) In general.--The Secretary shall, with
respect to the first 18-month period of the
demonstration project conducted under paragraph
(1), award planning grants to at least 10
States selected in accordance with subparagraph
(B) for purposes of preparing an application
described in paragraph (4)(C) and carrying out
the activities described in subparagraph (C).
(B) Selection.--In selecting States for
purposes of this paragraph, the Secretary
shall--
(i) select States that have a State
plan (or waiver of the State plan)
approved under this title;
(ii) select States in a manner that
ensures geographic diversity; and
(iii) give preference to States with
a prevalence of substance use disorders
(in particular opioid use disorders)
that is comparable to or higher than
the national average prevalence, as
measured by aggregate per capita drug
overdoses, or any other measure that
the Secretary deems appropriate.
(C) Activities described.--Activities
described in this subparagraph are, with
respect to a State, each of the following:
(i) Activities that support the
development of an initial assessment of
the behavioral health treatment needs
of the State to determine the extent to
which providers are needed (including
the types of such providers and
geographic area of need) to improve the
network of providers that treat
substance use disorders under the State
plan (or waiver), including the
following:
(I) An estimate of the number
of individuals enrolled under
the State plan (or a waiver of
such plan) who have a substance
use disorder.
(II) Information on the
capacity of providers to
provide substance use disorder
treatment or recovery services
to individuals enrolled under
the State plan (or waiver),
including information on
providers who provide such
services and their
participation under the State
plan (or waiver).
(III) Information on the gap
in substance use disorder
treatment or recovery services
under the State plan (or
waiver) based on the
information described in
subclauses (I) and (II).
(IV) Projections regarding
the extent to which the State
participating under the
demonstration project would
increase the number of
providers offering substance
use disorder treatment or
recovery services under the
State plan (or waiver) during
the period of the demonstration
project.
(ii) Activities that, taking into
account the results of the assessment
described in clause (i), support the
development of State infrastructure to,
with respect to the provision of
substance use disorder treatment or
recovery services under the State plan
(or a waiver of such plan), recruit
prospective providers and provide
training and technical assistance to
such providers.
(D) Funding.--For purposes of subparagraph
(A), there is appropriated, out of any funds in
the Treasury not otherwise appropriated,
$50,000,000, to remain available until
expended.
(4) Post-planning states.--
(A) In general.--The Secretary shall, with
respect to the remaining 36-month period of the
demonstration project conducted under paragraph
(1), select not more than 5 States in
accordance with subparagraph (B) for purposes
of carrying out the activities described in
paragraph (2) and receiving payments in
accordance with paragraph (5).
(B) Selection.--In selecting States for
purposes of this paragraph, the Secretary
shall--
(i) select States that received a
planning grant under paragraph (3);
(ii) select States that submit to the
Secretary an application in accordance
with the requirements in subparagraph
(C), taking into consideration the
quality of each such application;
(iii) select States in a manner that
ensures geographic diversity; and
(iv) give preference to States with a
prevalence of substance use disorders
(in particular opioid use disorders)
that is comparable to or higher than
the national average prevalence, as
measured by aggregate per capita drug
overdoses, or any other measure that
the Secretary deems appropriate.
(C) Applications.--
(i) In general.--A State seeking to
be selected for purposes of this
paragraph shall submit to the
Secretary, at such time and in such
form and manner as the Secretary
requires, an application that includes
such information, provisions, and
assurances, as the Secretary may
require, in addition to the following:
(I) A proposed process for
carrying out the ongoing
assessment described in
paragraph (2)(A), taking into
account the results of the
initial assessment described in
paragraph (3)(C)(i).
(II) A review of
reimbursement methodologies and
other policies related to
substance use disorder
treatment or recovery services
under the State plan (or
waiver) that may create
barriers to increasing the
number of providers delivering
such services.
(III) The development of a
plan, taking into account
activities carried out under
paragraph (3)(C)(ii), that will
result in long-term and
sustainable provider networks
under the State plan (or
waiver) that will offer a
continuum of care for substance
use disorders. Such plan shall
include the following:
(aa) Specific
activities to increase
the number of providers
(including providers
that specialize in
providing substance use
disorder treatment or
recovery services,
hospitals, health care
systems, Federally
qualified health
centers, and, as
applicable, certified
community behavioral
health clinics) that
offer substance use
disorder treatment,
recovery, or support
services, including
short-term
detoxification
services, outpatient
substance use disorder
services, and evidence-
based peer recovery
services.
(bb) Strategies that
will incentivize
providers described in
subparagraphs (C) and
(D) of paragraph (2) to
obtain the necessary
training, education,
and support to deliver
substance use disorder
treatment or recovery
services in the State.
(cc) Milestones and
timeliness for
implementing activities
set forth in the plan.
(dd) Specific
measurable targets for
increasing the
substance use disorder
treatment and recovery
provider network under
the State plan (or a
waiver of such plan).
(IV) A proposed process for
reporting the information
required under paragraph
(6)(A), including information
to assess the effectiveness of
the efforts of the State to
expand the capacity of
providers to deliver substance
use disorder treatment or
recovery services during the
period of the demonstration
project under this subsection.
(V) The expected financial
impact of the demonstration
project under this subsection
on the State.
(VI) A description of all
funding sources available to
the State to provide substance
use disorder treatment or
recovery services in the State.
(VII) A preliminary plan for
how the State will sustain any
increase in the capacity of
providers to deliver substance
use disorder treatment or
recovery services resulting
from the demonstration project
under this subsection after the
termination of such
demonstration project.
(VIII) A description of how
the State will coordinate the
goals of the demonstration
project with any waiver granted
(or submitted by the State and
pending) pursuant to section
1115 for the delivery of
substance use services under
the State plan, as applicable.
(ii) Consultation.--In completing an
application under clause (i), a State
shall consult with relevant
stakeholders, including Medicaid
managed care plans, health care
providers, and Medicaid beneficiary
advocates, and include in such
application a description of such
consultation.
(5) Payment.--
(A) In general.--For each quarter occurring
during the period for which the demonstration
project is conducted (after the first 18 months
of such period), the Secretary shall pay under
this subsection, subject to subparagraph (C),
to each State selected under paragraph (4) an
amount equal to 80 percent of so much of the
qualified sums expended during such quarter.
(B) Qualified sums defined.--For purposes of
subparagraph (A), the term ``qualified sums''
means, with respect to a State and a quarter,
the amount equal to the amount (if any) by
which the sums expended by the State during
such quarter attributable to substance use
disorder treatment or recovery services
furnished by providers participating under the
State plan (or a waiver of such plan) exceeds
1/4 of such sums expended by the State during
fiscal year 2018 attributable to substance use
disorder treatment or recovery services.
(C) Non-duplication of payment.--In the case
that payment is made under subparagraph (A)
with respect to expenditures for substance use
disorder treatment or recovery services
furnished by providers participating under the
State plan (or a waiver of such plan), payment
may not also be made under subsection (a) with
respect to expenditures for the same services
so furnished.
(6) Reports.--
(A) State reports.--A State receiving
payments under paragraph (5) shall, for the
period of the demonstration project under this
subsection, submit to the Secretary a quarterly
report, with respect to expenditures for
substance use disorder treatment or recovery
services for which payment is made to the State
under this subsection, on the following:
(i) The specific activities with
respect to which payment under this
subsection was provided.
(ii) The number of providers that
delivered substance use disorder
treatment or recovery services in the
State under the demonstration project
compared to the estimated number of
providers that would have otherwise
delivered such services in the absence
of such demonstration project.
(iii) The number of individuals
enrolled under the State plan (or a
waiver of such plan) who received
substance use disorder treatment or
recovery services under the
demonstration project compared to the
estimated number of such individuals
who would have otherwise received such
services in the absence of such
demonstration project.
(iv) Other matters as determined by
the Secretary.
(B) CMS reports.--
(i) Initial report.--Not later than
October 1, 2020, the Administrator of
the Centers for Medicare & Medicaid
Services shall, in consultation with
the Director of the Agency for
Healthcare Research and Quality and the
Assistant Secretary for Mental Health
and Substance Use, submit to Congress
an initial report on--
(I) the States awarded
planning grants under paragraph
(3);
(II) the criteria used in
such selection; and
(III) the activities carried
out by such States under such
planning grants.
(ii) Interim report.--Not later than
October 1, 2022, the Administrator of
the Centers for Medicare & Medicaid
Services shall, in consultation with
the Director of the Agency for
Healthcare Research and Quality and the
Assistant Secretary for Mental Health
and Substance Use, submit to Congress
an interim report--
(I) on activities carried out
under the demonstration project
under this subsection;
(II) on the extent to which
States selected under paragraph
(4) have achieved the stated
goals submitted in their
applications under subparagraph
(C) of such paragraph;
(III) with a description of
the strengths and limitations
of such demonstration project;
and
(IV) with a plan for the
sustainability of such project.
(iii) Final report.--Not later than
October 1, 2024, the Administrator of
the Centers for Medicare & Medicaid
Services shall, in consultation with
the Director of the Agency for
Healthcare Research and Quality and the
Assistant Secretary for Mental Health
and Substance Use, submit to Congress a
final report--
(I) providing updates on the
matters reported in the interim
report under clause (ii);
(II) including a description
of any changes made with
respect to the demonstration
project under this subsection
after the submission of such
interim report; and
(III) evaluating such
demonstration project.
(C) AHRQ report.--Not later than 3 years
after the date of the enactment of this
subsection, the Director of the Agency for
Healthcare Research and Quality, in
consultation with the Administrator of the
Centers for Medicare & Medicaid Services, shall
submit to Congress a summary on the experiences
of States awarded planning grants under
paragraph (3) and States selected under
paragraph (4).
(7) Data sharing and best practices.--During the
period of the demonstration project under this
subsection, the Secretary shall, in collaboration with
States selected under paragraph (4), facilitate data
sharing and the development of best practices between
such States and States that were not so selected.
(8) CMS funding.--There is appropriated, out of any
funds in the Treasury not otherwise appropriated,
$5,000,000 to the Centers for Medicare & Medicaid
Services for purposes of implementing this subsection.
Such amount shall remain available until expended.
(bb) Supplemental Payment Reporting Requirements.--
(1) Collection and availability of supplemental
payment data.--
(A) In general.--Not later than October 1,
2021, the Secretary shall establish a system
for each State to submit reports, as determined
appropriate by the Secretary, on supplemental
payments data, as a requirement for a State
plan or State plan amendment that would provide
for a supplemental payment.
(B) Requirements.--Each report submitted by a
State in accordance with the requirement
established under subparagraph (A) shall
include the following:
(i) An explanation of how
supplemental payments made under the
State plan or a State plan amendment
will result in payments that are
consistent with section 1902(a)(30)(A),
including standards with respect to
efficiency, economy, quality of care,
and access, along with the stated
purpose and intended effects of the
supplemental payment.
(ii) The criteria used to determine
which providers are eligible to receive
the supplemental payment.
(iii) A comprehensive description of
the methodology used to calculate the
amount of, and distribute, the
supplemental payment to each eligible
provider, including--
(I) data on the amount of the
supplemental payment made to
each eligible provider, if
known, or, if the total amount
is distributed using a formula
based on data from 1 or more
fiscal years, data on the total
amount of the supplemental
payments for the fiscal year or
years available to all
providers eligible to receive a
supplemental payment;
(II) if applicable, the
specific criteria with respect
to Medicaid service,
utilization, or cost data to be
used as the basis for
calculations regarding the
amount or distribution of the
supplemental payment; and
(III) the timing of the
supplemental payment made to
each eligible provider.
(iv) An assurance that the total
Medicaid payments made to an inpatient
hospital provider, including the
supplemental payment, will not exceed
upper payment limits.
(v) If not already submitted, an
upper payment limit demonstration under
section 447.272 of title 42, Code of
Federal Regulations (as such section is
in effect as of the date of enactment
of this subsection).
(C) Public availability.--The Secretary shall
make all reports and related data submitted
under this paragraph publicly available on the
website of the Centers for Medicare & Medicaid
Services on a timely basis.
(2) Supplemental payment defined.--
(A) In general.--Subject to subparagraph (B),
in this subsection, the term ``supplemental
payment'' means a payment to a provider that is
in addition to any base payment made to the
provider under the State plan under this title
or under demonstration authority.
(B) DSH payments excluded.--Such term does
not include a disproportionate share hospital
payment made under section 1923.
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