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115th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 115-731
======================================================================
RURAL DEVELOPMENT OF OPIOID CAPACITY SERVICES ACT
_______
June 12, 2018.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Walden, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 5477]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5477) to amend title XIX of the Social Security
Act to provide for a demonstration project to increase
substance use provider capacity under the Medicaid program,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 6
Background and Need for Legislation.............................. 6
Committee Action................................................. 8
Committee Votes.................................................. 9
Oversight Findings and Recommendations........................... 9
New Budget Authority, Entitlement Authority, and Tax Expenditures 9
Congressional Budget Office Estimate............................. 9
Federal Mandates Statement....................................... 31
Statement of General Performance Goals and Objectives............ 31
Duplication of Federal Programs.................................. 31
Committee Cost Estimate.......................................... 31
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 32
Disclosure of Directed Rule Makings.............................. 32
Advisory Committee Statement..................................... 32
Applicability to Legislative Branch.............................. 32
Section-by-Section Analysis of the Legislation................... 32
Changes in Existing Law Made by the Bill, as Reported............ 32
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Rural Development of Opioid Capacity
Services Act'' or the ``Rural DOCS Act''.
SEC. 2. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE PROVIDER
CAPACITY UNDER THE MEDICAID PROGRAM.
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended
by adding at the end the following new subsection:
``(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 section, 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 5-year 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 42-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;
``(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) 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, postpartum 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 42-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
received 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 subparagraphs (C) and (D), 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
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
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 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.
``(D) Conditions.--In the case of a State selected
under paragraph (4) that provides substance use
disorder treatment and recovery services under a waiver
under section 1115, such State shall, as a condition of
receiving payments under subparagraph (A)--
``(i) coordinate such services under such
waiver with substance use disorder treatment
and recovery services provided under the
demonstration project under this subsection;
and
``(ii) take such actions as appropriate under
the demonstration project to expand such
services under such waiver.
``(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 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 three years after
the date of the enactment of this subsection, the
Director of the Agency for Healthcare Research and
Quality 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.''.
Purpose and Summary
H.R. 5477 was introduced on April 11, 2018, by Rep. Tom
O'Halleran (D-AZ). The bill requires the Centers for Medicare
and Medicaid Services (CMS) to carry out a demonstration
project to provide an enhanced federal matching rate for state
Medicaid expenditures related to the expansion of substance-use
treatment and recovery services.
Background and Need for Legislation
Deaths due to overdoses of opioids and other drugs have
ravaged American communities. According to the Centers for
Disease Control and Prevention (CDC), on average, 1,000 people
are treated for opioid misuse in emergency departments per day,
an average of 115 Americans die per day, and opioid-related
overdoses have increased steadily since 1999.\1\
---------------------------------------------------------------------------
\1\Centers for Disease Control and Prevention. ``Drug Overdose
Death Data.'' December 19, 2017. Available at https://www.cdc.gov/
drugoverdose/data/statedeaths.html.
---------------------------------------------------------------------------
While the impacts to Americans' health outcomes are
staggering, the opioid crisis has negatively impacted society
in numerous ways. The Centers for Disease Control and
Prevention note that life expectancy dropped in 2015 and 2106
and that one of the reasons was an increase in unintentional
injuries, a category that includes drug overdoses.\2\ The
opioid crisis has also resulted in a contraction in the labor
force by almost 1 million workers in the years between 1999 and
2015, which resulted in a loss of $702 billion in real
output.\3\ In 2015, the total economic burden of the opioid
epidemic was estimated to be $504 billion.\4\ While all states
were negatively impacted, there is geographic variation in the
burden. West Virginia had the greatest loss per person ($4,378)
and Nebraska had the lowest loss per person ($394).\4\ One
recent analysis found that the annual cost for private sector
employers for treating opioid addiction and overdoses has
increased more than eight-fold since 2004, and more than one in
five persons aged 55 to 64 had at least one opioid prescription
in 2016.\5\
---------------------------------------------------------------------------
\2\Dowell, D., Arias E., Kochanek K. et al. ``Contribution of
Opioid-Involved Poisoning to the Change in Life Expectancy in the
United States, 2000-2015.'' JAMA, September 2017. Available at https://
jamanetwork.com/journals/jama/fullarticle/2654372.
\3\American Action Forum. ``The Labor Force and Output Consequences
of the Opioid Crisis.'' March 27, 2018. Available at https://
www.americanactionforum.org/research/labor-force-output-consequences-
opioid-crisis/.
\4\American Enterprise Institute. ``The Geographic Variation in the
Cost of the Opioid
Crisis''. Available at https://www.aei.org/wp-content/uploads/2018/03/
Geographic_Variation_
in_Cost_of_Opioid_Crisis.pdf.
\5\Kaiser Family Foundation, ``A Look at How the Opioid Crisis Has
Affected People with Employer Coverage,'' April 2018. Available online
at: https://www.kff.org/health-costs/press-release/analysis-cost-of-
treating-opioid-addiction-rose-rapidly-for-large-employers-as-the-
number-of-prescriptions-has-declined/.
---------------------------------------------------------------------------
Medicaid is the largest source of federal funding for
behavioral health services--mental health and substance use
disorder services--with nearly $71 billion in projected 2017
spending.\6\ As the Medicaid and CHIP Payment and Access
Commission (MACPAC) stated in 2017, ``the opioid epidemic,
which has reached most communities across the U.S.,
disproportionately affects Medicaid beneficiaries.''\7\ Of the
two million non-elderly Americans with opioid addiction,
Medicaid provides health coverage for an estimated 38 percent
of this population, which is the largest percentage of any
insurer type.\8\ Medicaid provides care to 4 in 10 adults with
opioid use disorder and compared to other insurance types,
provides a significantly higher percentage of inpatient and
outpatient substance use disorder treatment.\9\
---------------------------------------------------------------------------
\6\Government Accountability Office, ``Medicaid: States Fund
Services for Adults in Institutions for Mental Disease Using a Variety
of Strategies,'' GAO-17-652, August 2017. Available at https://
www.gao.gov/assets/690/686456.pdf.
\7\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
\8\Kaiser Family Foundation. ``Medicaid's Role in Addressing the
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/.
\9\Kaiser Family Foundation. ``Medicaid's Role in Addressing the
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/.
---------------------------------------------------------------------------
MACPAC found that ``Medicaid beneficiaries are prescribed
pain relievers at higher rates than those with other sources of
insurance. They also have a higher risk of overdose and other
negative outcomes, from both prescription opioids and illegal
opioids such as heroin and illicitly manufactured
fentanyl.''\10\ Not only are the number of Medicaid
beneficiaries with opioid misuse disproportionately high, so
too are the number of overdoses. Studies from North Carolina
and Washington indicate high rates of opioid-related deaths for
the Medicaid population (33 percent and 45 percent,
respectively).
---------------------------------------------------------------------------
\10\Medicaid and CHIP Payment and Access Commission, ``Medicaid and
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
---------------------------------------------------------------------------
For treatment, Medicaid has several pharmacy and medical
benefits for treating opioid use disorder that vary by state. A
primary pharmaceutical treatment offered to patients with
opioid abuse and/or substance use disorder is medication-
assisted treatment (MAT). The Substance Abuse and Mental Health
Services Administration (SAMHSA) describes MAT as ``the use of
FDA-approved medications, in combination with counseling and
behavioral therapies, to provide a ``whole-patient'' approach
to the treatment of substance use disorders.''\11\
---------------------------------------------------------------------------
\11\See SAMHSA website. Available at: https://www.samhsa.gov/
medication-assisted-treatment.
---------------------------------------------------------------------------
Non-pharmaceutical treatment of opioid use disorder in
Medicaid occurs in inpatient, outpatient, residential, and
community-based settings. MACPAC's 2017 analysis found that
``Medicaid is responding to the opioid crisis by covering
treatment, innovating in the delivery of care, and working with
other state agencies to reduce misuse of prescription
opioids.'' State Medicaid programs adopt strategies and design
their programs to meet the needs of their Medicaid
beneficiaries resulting in variations in covered treatment
services and settings. It is important state Medicaid programs
provide a continuum of care to serve the needs of Medicaid
beneficiaries.
However, as MACPAC noted, ``there are gaps in the continuum
of care, and states vary in the extent to which they cover
needed treatment.'' One of the barriers to appropriate
treatment consistently identified by Medicaid directors and
health policy experts is a statutory prohibition on federal
Medicaid matching funds for paying for care for certain
Medicaid beneficiaries in Institutions for Mental Diseases
(IMD). As MACPAC has explained, ``the Medicaid IMD exclusion
acts a barrier for individuals with an opioid use disorder to
receive residential treatment, which, depending on an
individual's treatment plan, may be the most appropriate
setting for care.'' Given these and other findings, there
continues to be an opportunity for Congress and state Medicaid
programs to work to improve access to timely, high-quality
treatment across the continuum of care.
One of the barriers to appropriate substance use disorder
treatment consistently identified by Medicaid directors and
health policy experts is a shortage of providers. A shortage of
providers creates barriers for Medicaid beneficiaries to access
treatment. Approximately 40 percent of U.S. counties lack a
single outpatient addiction treatment program that accepts any
Medicaid enrollees.\12\ In 2012, 96 percent of states,
including the District of Columbia, had opioid abuse or
dependence rates higher than their current buprenorphine
treatment capacity rates.\13\ In addition to the shortage of
providers, most opioid treatment programs are located in urban
areas, which causes significant regional disparities within and
among states.\14\
---------------------------------------------------------------------------
\12\Cummings, J.R., Wen, H., Ko, M. & Druss, B.G., ``Race/Ethnicity
and Geographic Access to Medicaid Substance Use Disorder Treatment
facilities in the United States,'' Journal of the American Medical
Association, Psychiatry, February 2014, 71(2), 190-196.
\13\Jones, C.M, Campopiano, M., Baldwin, G. & McCance-Katz, E.
``National and State Treatment Need and Capacity for Opioid Agonist
Medication-Assisted Treatment,'' American Journal of Public Health,
August 2015, 105(8), 55-63.
\14\Abraham, A.J., Andrews, C.M., Yingling, M.E. & Shannon, J.
``Geographic Disparities in Availability of Opioid Use Disorder
Treatment for Medicaid Enrollees,'' Health Services Research, February
2018, 53(1), 389-404.
---------------------------------------------------------------------------
Committee Action
On April 11 and 12, 2018, the Subcommittee on Health held a
hearing on H.R. 5477. The Subcommittee received testimony from:
Kimberly Brandt, Principal Deputy
Administrator for Operations, Centers for Medicare and
Medicaid Services, U.S. Department of Health and Human
Services;
Michael Botticelli, Executive Director,
Grayken Center for Addiction, Boston Medical Center;
Toby Douglas, Senior Vice President,
Medicaid Solutions, Centene Corporation;
David Guth, Chief Executive Officer,
Centerstone;
John Kravitz, Chief Information Officer,
Geisinger Health System; and,
Sam Srivastava, Chief Executive Officer,
Magellan Health.
On May 17, 2018, the full Committee on Energy and Commerce
met in open markup session and ordered H.R. 5477, as amended,
favorably reported to the House by a voice vote.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. There were no record votes taken in connection with
ordering H.R. 5477 reported.
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 5477 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, the following is
the cost estimate provided by the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed document with cost estimates for the
opioid-related legislation ordered to be reported on May 9 and
May 17, 2018.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Tom Bradley
and Chad Chirico.
Sincerely,
Mark P. Hadley
(For Keith Hall, Director).
Enclosure.
Opioid Legislation
Summary: On May 9 and May 17, 2018, the House Committee on
Energy and Commerce ordered 59 bills to be reported related to
the nation's response to the opioid epidemic. Generally, the
bills would:
Provide grants to facilities and providers
that treat people with substance use disorders,
Direct various agencies within the
Department of Health and Human Services (HHS) to
explore nonopioid approaches to treating pain and to
educate providers about those alternatives,
Modify requirements under Medicaid and
Medicare for prescribing controlled substances,
Expand Medicaid coverage for substance abuse
treatment, and
Direct the Food and Drug Administration
(FDA) to modify its oversight of opioid drugs and other
medications that are used to manage pain.
Because of the large number of related bills ordered
reported by the Committee, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting 20 of the bills would affect
direct spending, and 2 of the bills would affect revenues;
therefore, pay-as-you-go procedures apply for those bills.
CBO estimates that enacting H.R. 4998, the Health Insurance
for Former Foster Youth Act, would increase net direct spending
by more than $2.5 billion and on-budget deficits by more than
$5 billion in at least one of the four consecutive 10-year
periods beginning in 2029. None of the remaining 58 bills
included in this estimate would increase net direct spending by
more than $2.5 billion or on-budget deficits by more than $5
billion in any of the four consecutive 10-year periods
beginning in 2029.
One of the bills reviewed for this document, H.R. 5795,
would impose both intergovernmental and private-sector mandates
as defined in the Unfunded Mandates Reform Act (UMRA). CBO
estimates that the costs of those mandates on public and
private entities would fall below the thresholds in UMRA ($80
million and $160 million, respectively, in 2018, adjusted
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R.
5554, H.R. 5687, and H.R. 5811, would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of the bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would not exceed the UMRA threshold for private
entities. Because CBO is uncertain how federal agencies would
implement new authority granted in the other two bills, H.R.
5228 and H.R. 5687, CBO cannot determine whether the costs of
those mandates would exceed the UMRA threshold.
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all 59 bills were combined and enacted as one
piece of legislation, the budgetary effects would be different
from the sum of the estimates in this document, although CBO
expects that any such differences would be small. The costs of
this legislation fall within budget functions 550 (health), 570
(Medicare), 750 (administration of justice), and 800 (general
government).
Basis of estimate: For this estimate, CBO assumes that all
of the legislation will be enacted late in 2018 and that
authorized and estimated amounts will be appropriated each
year. Outlays for discretionary programs are estimated based on
historical spending patterns for similar programs.
Uncertainty
CBO aims to produce estimates that generally reflect the
middle of a range of the most likely budgetary outcomes that
would result if the legislation was enacted. Because data on
the utilization of mental health and substance abuse treatment
under Medicaid and Medicare is scarce, CBO cannot precisely
predict how patients or providers would respond to some policy
changes or what budgetary effects would result. In addition,
several of the bills would give the Department of Health and
Human Services (HHS) considerable latitude in designing and
implementing policies. Budgetary effects could differ from
those provided in CBO's analyses depending on those decisions.
Direct spending and revenues
Table 1 lists the 22 bills of the 59 ordered to be reported
that would affect direct spending or revenues.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
Legislation Primarily Affecting
Medicaid:
H.R. 1925, At-Risk Youth 0 * 5 5 5 10 10 10 10 10 10 25 75
Medicaid Protection Act of
2017......................
H.R. 4998, Health Insurance 0 0 0 0 0 * 10 21 33 46 61 * 171
for Former Foster Youth
Act.......................
H.R. 5477, Rural 0 13 35 58 68 83 27 9 3 3 3 256 301
Development of Opioid
Capacity Services Act.....
H.R. 5583, a bill to amend 0 * * * * * * * * * * * *
title XI of the Social
Security Act to require
States to annually report
on certain adult health
quality measures, and for
other purposes............
H.R. 5797, IMD CARE Act.... 0 38 158 251 265 279 0 0 0 0 0 991 991
H.R. 5799, Medicaid DRUG 0 * * 1 1 1 1 1 1 1 1 2 5
Improvement Acta..........
H.R. 5801, Medicaid 0 * * * * * * * * * * * *
Providers Are Required To
Note Experiences in Record
Systems to Help In-Need
Patients (PARTNERSHIP)
Acta......................
H.R. 5808, Medicaid 0 * -1 -1 -1 -1 -2 -2 -2 -2 -2 -4 -13
Pharmaceutical Home Act of
2018a.....................
H.R. 5810, Medicaid Health 0 94 58 62 56 52 48 43 38 32 25 323 509
HOME Act..................
Legislation Primarily Affecting
Medicare:
H.R. 3528, Every 0 0 0 -24 -35 -33 -30 -33 -32 -31 -32 -92 -250
Prescription Conveyed
Securely Act..............
H.R. 4841, Standardizing 0 0 0 * * * * * * * * * *
Electronic Prior
Authorization for Safe
Prescribing Act of 2018...
H.R. 5603, Access to 0 2 * * * 1 1 1 2 2 2 3 11
Telehealth Services for
Opioid Use Disorders Act..
H.R. 5605, Advancing High 0 0 0 15 26 24 23 23 10 1 * 65 122
Quality Treatment for
Opioid Use Disorders in
Medicare Act..............
H.R. 5675, a bill to amend 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
title XVIII of the Social
Security Act to require
prescription drug plan
sponsors under the
Medicare program to
establish drug management
programs for at-risk
beneficiaries.............
H.R. 5684, Protecting 0 0 0 * * * * * * * * * *
Seniors From Opioid Abuse
Act.......................
H.R. 5796, Responsible 0 10 25 50 10 5 0 0 0 0 0 100 100
Education Achieves Care
and Healthy Outcomes for
Users' Treatment Act of
2018......................
H.R. 5798, Opioid Screening 0 0 * 1 1 1 1 1 1 1 1 2 5
and Chronic Pain
Management Alternatives
for Seniors Act...........
H.R. 5804, Post-Surgical 0 0 25 30 25 20 10 5 0 0 0 100 115
Injections as an Opioid
Alternative Acta..........
H.R. 5809, Postoperative 0 0 0 0 10 15 20 25 30 35 45 25 180
Opioid Prevention Act of
2018......................
Legislation Primarily Affecting
the Food and Drug
Administration:
H.R. 5333, Over-the-Counter 0 0 * * * * * * * * * * *
Monograph Safety,
Innovation, and Reform Act
of 2018a..................
INCREASES OR DECREASES (-) IN REVENUESb
H.R. 5752, Stop Illicit 0 * * * * * * * * * * * *
Drug Importation Act of
2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.
Legislation Primarily Affecting Medicaid. The following
nine bills would affect direct spending for the Medicaid
program.
H.R. 1925, the At-Risk Youth Medicaid Protection Act of
2017, would require states to suspend, rather than terminate,
Medicaid eligibility for juvenile enrollees (generally under 21
years of age) who become inmates of public correctional
institutions. States also would have to redetermine those
enrollees' Medicaid eligibility before their release and
restore their coverage upon release if they qualify for the
program. States would be required to process Medicaid
applications submitted by or on behalf of juveniles in public
correctional institutions who were not enrolled in Medicaid
before becoming inmates and ensure that Medicaid coverage is
provided when they are released if they are found to be
eligible. On the basis of an analysis of juvenile incarceration
trends and of the per enrollee spending for Medicaid foster
care children, who have a similar health profile to
incarcerated juveniles, CBO estimates that implementing the
bill would cost $75 million over the 2019-2028 period.
H.R. 4998, the Health Insurance for Former Foster Youth
Act, would require states to provide Medicaid coverage to
adults up to age 25 who had aged out of foster care in any
state. Under current law, such coverage is mandatory only if
the former foster care youth has aged out in the state in which
the individual applies for coverage. The policy also would
apply to former foster children who had been in foster care
upon turning 14 years of age but subsequently left foster care
to enter into a legal guardianship with a kinship caregiver.
The provisions would take effect respect for foster youth who
turn 18 on or after January 1, 2023. On the basis of spending
for Medicaid foster care children and data from the Census
Bureau regarding annual migration rates between states, CBO
estimates that implementing the bill would cost $171 million
over the 2019-2028 period.
H.R. 5477, the Rural Development of Opioid Capacity
Services Act, would direct the Secretary of HHS to conduct a
five-year demonstration to increase the number and ability of
providers participating in Medicaid to provide treatment for
substance use disorders. On the basis of an analysis of federal
and state spending for treatment of substance use disorders and
the prevalence of such disorders, CBO estimates that enacting
the bill would increase direct spending by $301 million over
the 2019-2028 period.
H.R. 5583, a bill to amend title XI of the Social Security
Act to require States to annually report on certain adult
health quality measures, and for other purposes, would require
states to include behavioral health indicators in their annual
reports on the quality of care under Medicaid. Although the
bill would add a requirement for states, CBO estimates that its
enactment would not have a significant budgetary effect because
most states have systems in place for reporting such measures
to the federal government.
H.R. 5797, the IMD CARE Act, would expand Medicaid coverage
for people with opioid use disorder who are in institutions for
mental disease (IMDs) for up to 30 days per year. Under a
current-law policy known as the IMD exclusion, the federal
government generally does not make matching payments to state
Medicaid programs for most services provided by IMDs to adults
between the ages of 21 and 64. Recent administrative changes
have made federal financing for IMDs available in limited
circumstances, but the statutory prohibition remains in place.
CBO analyzed several data sets, primarily those collected by
the Substance Abuse and Mental Health Services Administration
(SAMHSA), to estimate current federal spending under Medicaid
for IMD services and to estimate spending under H.R. 5797.
Using that analysis, CBO estimates that enacting H.R. 5797
would increase direct spending by $991 million over the 2019-
2028 period.
H.R. 5799, the Medicaid DRUG Improvement Act, would require
state Medicaid programs to implement additional reviews of
opioid prescriptions, monitor concurrent prescribing of opioids
and certain other drugs, and monitor use of antipsychotic drugs
by children. CBO estimates that the bill would increase direct
spending by $5 million over the 2019-2028 period to cover the
administrative costs of complying with those requirements. On
the basis of stakeholder feedback, CBO expects that the bill
would not have a significant effect on Medicaid spending for
prescription drugs because many of the bill's requirements
would duplicate current efforts to curb opioid and
antipsychotic drug use. (If enacted, H.R. 5799 also would
affect spending subject to appropriation; CBO has not completed
an estimate of that amount.)
H.R. 5801, the Medicaid Providers Are Required To Note
Experiences in Record Systems to Help In-Need Patients
(PARTNERSHIP) Act, would require providers who are permitted to
prescribe controlled substances and who participate in Medicaid
to query prescription drug monitoring programs (PDMPs) before
prescribing controlled substances to Medicaid patients. PDMPs
are statewide electronic databases that collect data on
controlled substances dispensed in the state. The bill also
would require PDMPs to comply with certain data and system
criteria, and it would provide additional federal matching
funds to certain states to help cover administrative costs. On
the basis of a literature review and stakeholder feedback, CBO
estimates that the net budgetary effect of enacting H.R. 5801
would be insignificant. Costs for states to come into
compliance with the systems and administrative requirements
would be roughly offset by savings from small reductions in the
number of controlled substances paid for by Medicaid under the
proposal. (If enacted, H.R. 5801 also would affect spending
subject to appropriation; CBO has not completed an estimate of
that amount.)
H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018,
would require state Medicaid programs to operate pharmacy
programs that would identify people at high risk of abusing
controlled substances and require those patients to use a
limited number of providers and pharmacies. Although nearly all
state Medicaid programs currently meet such a requirement, a
small number of high-risk Medicaid beneficiaries are not now
monitored. Based on an analysis of information about similar
state and federal programs, CBO estimates that net Medicaid
spending under the bill would decrease by $13 million over the
2019-2028 period. That amount represents a small increase in
administrative costs and a small reduction in the number of
controlled substances paid for by Medicaid under the proposal.
(If enacted, H.R. 5808 also would affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5810, the Medicaid Health HOME Act, would allow states
to receive six months of enhanced federal Medicaid funding for
programs that coordinate care for people with substance use
disorders. Based on enrollment and spending data from states
that currently participate in Medicaid's Health Homes program,
CBO estimates that the expansion would cost approximately $469
million over the 2019-2028 period. The bill also would require
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a
waiver from that requirement. (Medication-assisted treatment
combines behavioral therapy and pharmaceutical treatment for
substance use disorders.) Under current law, states already
cover most FDA-approved drugs used in such programs in some
capacity, although a few exclude methadone dispensed by opioid
treatment programs. CBO estimates that a small share of those
states would begin to cover methadone if this bill was enacted
at a federal cost of about $39 million over the 2019-2028
period. In sum, CBO estimates that the enacting H.R. 5810 would
increase direct spending by $509 million over the 2019-2028
period.
Legislation Primarily Affecting Medicare. The following ten
bills would affect direct spending for the Medicare program.
H.R. 3528, the Every Prescription Conveyed Securely Act,
would require prescriptions for controlled substances covered
under Medicare Part D to be transmitted electronically,
starting on January 1, 2021. Based on CBO's analysis of
prescription drug spending, spending for controlled substances
is a small share of total drug spending. CBO also assumes a
small share of those prescriptions would not be filled because
they are not converted to an electronic format. Therefore, CBO
expects that enacting H.R. 3528 would reduce the number of
prescriptions filled and estimates that Medicare spending would
be reduced by $250 million over the 2019-2028 period.
H.R. 4841, the Standardizing Electronic Prior Authorization
for Safe Prescribing Act of 2018, would require health care
professionals to submit prior authorization requests
electronically, starting on January 1, 2021, for drugs covered
under Medicare Part D. Taking into account that many
prescribers already use electronic methods to submit such
requests, CBO estimates that enacting H.R. 4841 would not
significantly affect direct spending for Part D.
H.R. 5603, the Access to Telehealth Services for Opioid Use
Disorders Act, would permit the Secretary of HHS to lift
current geographic and other restrictions on coverage of
telehealth services under Medicare for treatment of substance
use disorders or co-occurring mental health disorders. Under
the bill, the Secretary of HHS would be directed to encourage
other payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on current use of Medicare
telehealth services for treatment of substance use disorders,
CBO estimates that expanding that coverage would increase
direct spending by $11 million over the 2019-2028 period.
H.R. 5605, the Advancing High Quality Treatment for Opioid
Use Disorders in Medicare Act, would establish a five-year
demonstration program to increase access to treatment for
opioid use disorder. The demonstration would provide incentive
payments and funding for care management services based on
criteria such as patient engagement, use of evidence-based
treatments, and treatment length and intensity. Under the bill,
the Secretary of HHS would be directed to encourage other
payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on historical utilization of
opioid use disorder treatments and projected spending on
incentive payments and care management fees, CBO estimates that
increased use of treatment services and the demonstration's
incentive payments would increase direct spending by $122
million over the 2019-2028 period.
H.R. 5675, a bill to amend title XVIII of the Social
Security Act to require prescription drug plan sponsors under
the Medicare program to establish drug management programs for
at-risk beneficiaries, would require Part D prescription drug
plans to provide drug management programs for Medicare
beneficiaries who are at risk for prescription drug abuse.
(Under current law, Part D plans are permitted but not required
to establish such programs as of 2019.) Based on an analysis of
the number of plans currently providing those programs, CBO
estimates that enacting H.R. 5675 would lower federal spending
by $64 million over the 2019-2028 period by reducing the number
of prescriptions filled and Medicare's payments for controlled
substances.
H.R. 5684, the Protecting Seniors From Opiod Abuse Act,
would expand medication therapy management programs under
Medicare Part D to include beneficiaries who are at risk for
prescription drug abuse. Because relatively few beneficiaries
would be affected by this bill, CBO estimates that its
enactment would not significantly affect direct spending for
Part D.
H.R. 5796, the Responsible Education Achieves Care and
Healthy Outcomes for Users' Treatment Act of 2018, would allow
the Secretary of HHS to award grants to certain organizations
that provide technical assistance and education to high-volume
prescribers of opioids. The bill would appropriate $100 million
for fiscal year 2019. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 5796
would cost $100 million over the 2019-2028 period.
H.R. 5798, the Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act, would add an assessment of
current opioid prescriptions and screening for opioid use
disorder to the Welcome to Medicare Initial Preventive Physical
Examination. Based on historical use of the examinations and
pain management alternatives, CBO expects that enacting the
bill would increase use of pain management services and
estimates that direct spending would increase by $5 million
over the 2019-2028 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers (ASCs). (For injections identified by specific billing
codes, Medicare would pay the 2016 rate, which is higher than
the current rate, during the 2020-2024 period.) Based on
current utilization in the ASC setting, CBO estimates that
enacting the legislation would increase direct spending by
about $115 million over the 2019-2028 period. (If enacted, H.R.
5804 also would affect spending subject to appropriation; see
Table 3.)
H.R. 5809, the Postoperative Opioid Prevention Act of 2018,
would create an additional payment under Medicare for nonopioid
analgesics. Under current law, certain new drugs and devices
may receive an additional payment--separate from the bundled
payment for a surgical procedure--in outpatient hospital
departments and ambulatory surgical centers. The bill would
allow nonopioid analgesics to qualify for a five-year period of
additional payments. Based on its assessment of current
spending for analgesics and on the probability of new nonopioid
analgesics coming to market, CBO estimates that H.R. 5809 would
increase direct spending by about $180 million over the 2019-
2028 period.
Legislation Primarily Affecting the Food and Drug
Administration. One bill related to the FDA would affect direct
spending.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the way that
the FDA regulates the marketing of over-the-counter (OTC)
medicines, and it would authorize that agency to grant 18
months of exclusive market protection for certain qualifying
OTC drugs, thus delaying the entry of other versions of the
same qualifying OTC product. Medicaid currently provides some
coverage for OTC medicines, but only if a medicine is the least
costly alternative in its drug class. On the basis of
stakeholder feedback, CBO expects that delaying the
availability of additional OTC versions of a drug would not
significantly affect the average net price paid by Medicaid. As
a result, CBO estimates that enacting H.R. 5333 would have a
negligible effect on the federal budget. (If enacted, H.R. 5333
also would affect spending subject to appropriation; see Table
3.)
Legislation with Revenue Effects. Two bills would affect
revenues. However, CBO estimates that one bill, H.R. 5228, the
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement
Now Act, would have only a negligible effect.
H.R. 5752, the Stop Illicit Drug Importation Act of 2018,
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to
strengthen the FDA's seizure powers and enhance its authority
to detain, refuse, seize, or destroy illegal products offered
for import. The legislation would subject more people to
debarment under the FDCA and thus increase the potential for
violations, and subsequently, the assessment of civil
penalties, which are recorded in the budget as revenues. CBO
estimates that those collections would result in an
insignificant increase in revenues. Because H.R. 5752 would
prohibit the importation of drugs that are in the process of
being scheduled, it also could reduce amounts collected in
customs duties. CBO anticipates that the result would be a
negligible decrease in revenues. With those results taken
together, CBO estimates, enacting H.R. 5752 would generate an
insignificant net increase in revenues over the 2019-2028
period.
Spending Subject to Appropriation
For this document, CBO has grouped bills with spending that
would be subject to appropriation into four general categories:
Bills that would have no budgetary effect,
Bills with provisions that would authorize
specified amounts to be appropriated (see Table 2),
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
3), and
Bills with provisions that would affect
spending subject to appropriation for which CBO has not
yet completed an estimate.
No Budgetary Effect. CBO estimates that 6 of the 59 bills
would have no effect on direct spending, revenues, or spending
subject to appropriation.
H.R. 3192, the CHIP Mental Health Parity Act, would require
all Children's Health Insurance Program (CHIP) plans to cover
mental health and substance abuse treatment. In addition,
states would not be allowed to impose financial or utilization
limits on mental health treatment that are lower than limits
placed on physical health treatment. Based on information from
the Centers for Medicare and Medicaid Services, CBO estimates
that enacting the bill would have no budgetary effect because
all CHIP enrollees are already in plans that meet those
requirements.
H.R. 3331, a bill to amend title XI of the Social Security
Act to promote testing of incentive payments for behavioral
health providers for adoption and use of certified electronic
health record technology, would give the Center for Medicare
and Medicaid Innovation (CMMI) explicit authorization to test a
program offering incentive payments to behavioral health
providers that adopt and use certified electronic health record
technology. Because it is already clear to CMMI that it has
that authority, CBO estimates that enacting the legislation
would not affect federal spending.
H.R. 5202, the Ensuring Patient Access to Substance Use
Disorder Treatments Act of 2018, would clarify permission for
pharmacists to deliver controlled substances to providers under
certain circumstances. Because this provision would codify
current practice, CBO estimates that H.R. 5202 would not affect
direct spending or revenues during the 2019-2028 period.
H.R. 5685, the Medicare Opioid Safety Education Act of
2018, would require the Secretary of HHS to include information
on opioid use, pain management, and nonopioid pain management
treatments in future editions of Medicare & You, the program's
handbook for beneficiaries, starting on January 1, 2019.
Because H.R. 5685 would add information to an existing
administrative document, CBO estimates that enacting the bill
would have no budgetary effect.
H.R. 5686, the Medicare Clear Health Options in Care for
Enrollees Act of 2018, would require prescription drug plans
that provide coverage under Medicare Part D to furnish
information to beneficiaries about the risks of opioid use and
the availability of alternative treatments for pain. CBO
estimates that enacting the bill would not affect direct
spending because the required activities would not impose
significant administrative costs.
H.R. 5716, the Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors Act, would require the
Secretary of HHS on an annual basis to identify high
prescribers of opioids and furnish them with information about
proper prescribing methods. Because HHS already has the
capacity to meet those requirements, CBO estimates that
enacting that provision would not impose additional
administrative costs on the agency.
Specified Authorizations. Table 2 lists the ten bills that
would authorize specified amounts to be appropriated over the
2019-2023 period. Spending from those authorized amounts would
be subject to appropriation.
TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 4684, Ensuring Access to Quality Sober Living
Act:
Authorization Level.............................. 0 3 0 0 0 0 3
Estimated Outlays................................ 0 1 2 * * * 3
H.R. 5102, Substance Use Disorder Workforce Loan
Repayment Act of 2018:
Authorization Level.............................. 0 25 25 25 25 25 125
Estimated Outlays................................ 0 9 19 23 25 25 100
H.R. 5176, Preventing Overdoses While in Emergency
Rooms Act of 2018:
Authorization Level.............................. 0 50 0 0 0 0 50
Estimated Outlays................................ 0 16 26 6 2 1 50
H.R. 5197, Alternatives to Opioids (ALTO) in the
Emergency Department Act:
Authorization Level.............................. 0 10 10 10 0 0 30
Estimated Outlays................................ 0 3 8 10 7 2 30
H.R. 5261, Treatment, Education, and Community Help
to Combat Addiction Act of 2018:
Authorization Level.............................. 0 4 4 4 4 4 20
Estimated Outlays................................ 0 1 3 4 4 4 16
H.R. 5327, Comprehensive Opioid Recovery Centers Act
of 2018:
Authorization Level.............................. 0 10 10 10 10 10 50
Estimated Outlays................................ 0 3 8 10 10 10 41
H.R. 5329, Poison Center Network Enhancement Act of
2018:
Authorization Level.............................. 0 30 30 30 30 30 151
Estimated Outlays................................ 0 12 25 29 29 29 125
H.R. 5353, Eliminating Opioid-Related Infectious
Diseases Act of 2018:
Authorization Level.............................. 0 40 40 40 40 40 200
Estimated Outlays................................ 0 15 34 38 39 40 166
H.R. 5580, Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018:
Authorization Level.............................. 30 30 30 30 30 0 120
Estimated Outlays................................ 0 11 25 29 29 19 113
H.R. 5587, Peer Support Communities of Recovery Act:
Authorization Level.............................. 0 15 15 15 15 15 75
Estimated Outlays................................ 0 5 13 14 15 15 62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.
H.R. 4684, the Ensuring Access to Quality Sober Living Act,
would direct the Secretary of HHS to develop and disseminate
best practices for organizations that operate housing designed
for people recovering from substance use disorders. The bill
would authorize a total of $3 million over the 2019-2021 period
for that purpose. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 4684
would cost $3 million over the 2019-2023 period.
H.R. 5102, the Substance Use Disorder Workforce Loan
Repayment Act of 2018, would establish a loan repayment program
for mental health professionals who practice in areas with few
mental health providers or with high rates of death from
overdose and would authorize $25 million per year over the
2019-2028 period for that purpose. Based on historical spending
patterns for similar activities, CBO estimates that
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years
after 2023.
H.R. 5176, the Preventing Overdoses While in Emergency
Rooms Act of 2018, would require the Secretary of HHS to
develop protocols and a grant program for health care providers
to address the needs of people who survive a drug overdose, and
it would authorize $50 million in 2019 for that purpose. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5176 would cost $50 million
over the 2019-2023 period.
H.R. 5197, the Alternatives to Opioids (ALTO) in the
Emergency Department Act, would direct the Secretary of HHS to
carry out a demonstration program for hospitals and emergency
departments to develop alternative protocols for pain
management that limit the use of opioids and would authorize
$10 million annually in grants for fiscal years 2019 through
2021. Based on historical spending patterns for similar
programs, CBO estimates that implementing H.R. 5197 would cost
$30 million over the 2019-2023 period.
H.R. 5261, the Treatment, Education, and Community Help to
Combat Addiction Act of 2018, would direct the Secretary of
HHS to designate regional centers of excellence to improve the
training of health professionals who treat substance use
disorders. The bill would authorize $4 million annually for
grants to those programs over the 2019-2023 period. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5261 would cost $16 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5327, the Comprehensive Opioid Recovery Centers Act of
2018, would direct the Secretary of HHS to award grants to at
least 10 providers that offer treatment services for people
with opioid use disorder, and it would authorize $10 million
per year over the 2019-2023 period for that purpose. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5327 would cost $41 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5329, the Poison Center Network Enhancement Act of
2018, would reauthorize the poison control center toll-free
number, national media campaign, and grant program under the
Public Health Service Act. Among other actions, H.R. 5329 would
increase the share of poison control center funding that could
be provided by federal grants. The bill would authorize a total
of about $30 million per year over the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5329 would cost $125 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R 5353, the Eliminating Opioid Related Infectious
Diseases Act of 2018, would amend the Public Health Service Act
by broadening the focus of surveillance and education programs
from preventing and treating hepatitis C virus to preventing
and treating infections associated with injection drug use. It
would authorize $40 million per year over 2019-2023 period for
that purpose. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5353 would
cost $166 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5580, the Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018, would establish a grant
program for public health laboratories that conduct testing for
fentanyl and other synthetic opioids. It also would direct the
Centers for Disease Control and Prevention to expand its drug
surveillance program, with a particular focus on collecting
data on fentanyl. The bill would authorize a total of $30
million per year over the 2018-2022 period for those
activities. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5580 would
cost $113 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5587, Peer Support Communities of Recovery Act, would
direct the Secretary of HHS to award grants to nonprofit
organizations that support community-based, peer-delivered
support, including technical support for the establishment of
recovery community organizations, independent, nonprofit groups
led by people in recovery and their families. The bill would
authorize $15 million per year for the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5587 would cost $62 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
Estimated Authorizations. Table 3 shows CBO's estimates of
the appropriations that would be necessary to implement 19 of
the bills. Spending would be subject to appropriation of those
amounts.
H.R. 449, the Synthetic Drug Awareness Act of 2018, would
require the Surgeon General to report to the Congress on the
health effects of synthetic psychoactive drugs on children
between the ages of 12 and 18. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 449
would cost approximately $1 million over the 2019-2023 period.
H.R. 4005, the Medicaid Reentry Act, would direct the
Secretary of HHS to convene a group of stakeholders to develop
and report to the Congress on best practices for addressing
issues related to health care faced by those returning from
incarceration to their communities. The bill also would require
the Secretary to issue a letter to state Medicaid directors
about relevant demonstration projects. Based on an analysis of
anticipated workload, CBO estimates that implementing H.R. 4005
would cost less than $500,000 over the 2018-2023 period.
H.R. 4275, the Empowering Pharmacists in the Fight Against
Opioid Abuse Act, would require the Secretary of HHS to develop
and disseminate materials for training pharmacists, health care
practitioners, and the public about the circumstances under
which a pharmacist may decline to fill a prescription. Based on
historical spending patterns for similar activities, CBO
estimates that costs to the federal government for the
development and distribution of those materials would not be
significant.
TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 449, Synthetic Drug Awareness Act of 2018:
Estimated Authorization Level................. 0 * * * 0 0 1
Estimated Outlays............................. 0 * * * 0 0 1
H.R. 4005, Medicaid Reentry Act:
Estimated Authorization Level................. * * 0 0 0 0 *
Estimated Outlays............................. * * 0 0 0 0 *
H.R. 4275, Empowering Pharmacists in the Fight
Against Opioid Abuse Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5009, Jessie's Law:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5041, Safe Disposal of Unused Medication Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5272, Reinforcing Evidence-Based Standards
Under Law in Treating Substance Abuse Act of
2018:
Estimated Authorization Level................. 0 1 1 1 1 1 4
Estimated Outlays............................. 0 1 1 1 1 1 4
H.R. 5333, Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018:a
Food and Drug Administration:
Collections from fees:
Estimated Authorization Level......... 0 -22 -22 -26 -35 -42 -147
Estimated Outlays..................... 0 -22 -22 -26 -35 -42 -147
Spending of fees:
Estimated Authorization Level......... 0 22 22 26 35 42 147
Estimated Outlays..................... 0 6 17 30 44 41 137
Net effect on FDA:
Estimated Authorization Level......... 0 0 0 0 0 0 0
Estimated Outlays..................... 0 -17 -6 4 9 * -10
Government Accountability Office:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 0 0 0 0 * *
Total, H.R. 5333:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 -17 -6 4 9 * -10
H.R. 5473, Better Pain Management Through Better
Data Act of 2018:
Estimated Authorization Level................. 0 * * * * 0 1
Estimated Outlays............................. 0 * * * * * 1
H.R. 5483, Special Registration for Telemedicine
Clarification Act of 2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5554, Animal Drug and Animal Generic Drug
User Fee Amendments of 2018:
Collections from fees:
Animal drug fees.......................... 0 -30 -31 -32 -33 -34 -159
Generic animal drug fees.................. 0 -18 -19 -19 -20 -21 -97
Total, Estimated Authorization Level.. 0 -49 -50 -51 -53 -55 -257
Total, Estimated Outlays.............. 0 -40 -50 -51 -53 -55 -257
Spending of fees:
Animal drug fees.......................... 0 30 31 32 33 34 159
Generic animal drug fees.................. 0 18 19 19 20 21 97
Total, Estimated Authorization Level.. 0 49 50 51 53 55 257
Total, Estimated Outlays.............. 0 39 47 51 52 54 243
Net changes in fees:
Estimated Authorization Level............. 0 0 0 0 0 0 0
Estimated Outlays......................... 0 -10 -3 * * * -14
Other effects:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 2 1 1 1 1 6
Total, H.R. 5554:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 -8 -2 1 * * -8
H.R. 5582, Abuse Deterrent Access Act of 2018:
Estimated Authorization Level................. 0 0 * 0 0 0 *
Estimated Outlays............................. 0 0 * 0 0 0 *
H.R. 5590, Opioid Addiction Action Plan Act:
Estimated Authorization Level................. * * * * * * 2
Estimated Outlays............................. * * * * * * 2
H.R. 5687, Securing Opioids and Unused Narcotics
with Deliberate Disposal and Packaging Act of
2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5715, Strengthening Partnerships to Prevent
Opioid Abuse Act:
Estimated Authorization Level................. 0 2 2 2 2 2 9
Estimated Outlays............................. 0 2 2 2 2 2 9
H.R. 5789, a bill to require the Secretary of
Health and Human Services to issue guidance to
improve care for infants with neonatal abstinence
syndrome and their mothers, and to require the
Comptroller General of the United States to
conduct a study on gaps in Medicaid coverage for
pregnant and postpartum women with substance use
disorder:
Estimated Authorization Level................. 0 2 0 0 0 0 2
Estimated Outlays............................. 0 2 0 0 0 0 2
H.R. 5795, Overdose Prevention and Patient Safety
Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 1 0 0 0 0 1
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 * * 0 0 0 1
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act:a
Estimated Authorization Level................. 0 0 0 0 1 1 1
Estimated Outlays............................. 0 0 0 0 1 1 1
H.R. 5811, a bill to amend the Federal Food, Drug,
and Cosmetic Act with respect to postapproval
study requirements for certain controlled
substances, and for other purposes:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).
H.R. 5009, Jessie's Law, would require HHS, in
collaboration with outside experts, to develop best practices
for displaying information about opioid use disorder in a
patient's medical record. HHS also would be required to develop
and disseminate written materials annually to health care
providers about what disclosures could be made while still
complying with federal laws that govern health care privacy.
Based on spending patterns for similar activities, CBO
estimates that implementing H.R. 5009 would have an
insignificant effect on spending over the 2019-2023 period.
H.R. 5041, the Safe Disposal of Unused Medication Act,
would require hospice programs to have written policies and
procedures for the disposal of controlled substances after a
patient's death. Certain licensed employees of hospice programs
would be permitted to assist in the disposal of controlled
substances that were lawfully dispensed. Using information from
the Department of Justice (DOJ), CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5272, the Reinforcing Evidence-Based Standards Under
Law in Treating Substance Abuse Act of 2018, would require the
newly established National Mental Health and Substance Use
Policy Laboratory to issue guidance to applicants for SAMHSA
grants that support evidence-based practices. Using information
from HHS about the historical cost of similar activities, CBO
estimates that enacting this bill would cost approximately $4
million over the 2019-2023 period.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the FDA's
oversight of the commercial marketing of OTC medicines and
authorize the collection and spending of fees through 2023 to
cover the costs of expediting the FDA's administrative
procedures for certain regulatory activities relating to OTC
products. Under H.R. 5333, CBO estimates, the FDA would assess
about $147 million in fees over the 2019-2023 period that could
be collected and made available for obligation only to the
extent and in the amounts provided in advance in appropriation
acts. Because the FDA could spend those fees, CBO estimates
that the estimated budget authority for collections and
spending would offset each other exactly in each year, although
CBO expects that spending initially would lag behind
collections. Assuming appropriation action consistent with the
bill, CBO estimates that implementing H.R. 5333 would reduce
net discretionary outlays by $10 million over the 2019-2023
period, primarily because of that lag. The bill also would
require the Government Accountability Office to study exclusive
market protections for certain qualifying OTC drugs authorized
by the bill--a provision that CBO estimates would cost less
than $500,000. (If enacted, H.R. 5333 also would affect
mandatory spending; see Table 1.)
H.R. 5473, the Better Pain Management Through Better Data
Act of 2018, would require that the FDA conduct a public
meeting and issue guidance to industry addressing data
collection and labeling for medical products that reduce pain
while enabling the reduction, replacement, or avoidance of oral
opioids. Using information from the agency, CBO estimates that
implementing H.R. 5473 would cost about $1 million over the
2019-2023 period.
H.R. 5483, the Special Registration for Telemedicine
Clarification Act of 2018, would direct DOJ, within one year of
the bill's enactment, to issue regulations concerning the
practice of telemedicine (for remote diagnosis and treatment of
patients). Using information from DOJ, CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would authorize the FDA to collect and
spend fees to cover the cost of expedited approval for the
development and marketing of certain drugs for use in animals.
The legislation would extend through fiscal year 2023, and make
several changes to, the FDA's existing approval processes and
fee programs for brand-name and generic veterinary drugs, which
expire at the end of fiscal year 2018. CBO estimates that
implementing H.R. 5554 would reduce net discretionary outlays
by $8 million over the 2019-2023 period, primarily because the
spending of fees lags somewhat behind their collection.
Fees authorized under the bill would supplement funds
appropriated to cover the FDA's cost of reviewing certain
applications and investigational submissions for brand-name and
generic drugs for use in animals. Those fees could be collected
and made available for obligation only to the extent and in the
amounts provided in advance in appropriation acts. Under H.R.
5554, CBO estimates, the FDA would assess about $257 million in
fees over the 2019-2023 period. Because the FDA could spend
those funds, CBO estimates that budget authority for
collections and spending would offset each other exactly in
each year. CBO estimates that the delay between collecting and
spending fees under the reauthorized programs would reduce net
discretionary outlays by $14 million over the 2019-2023 period,
assuming appropriation actions consistent with the bill.
Enacting H.R. 5554 would increase the FDA's workload
because the legislation would expand eligibility for
conditional approval for certain drugs. The agency's
administrative costs also would increase because of regulatory
activities required by a provision concerning petitions for
additives intended for use in animal food. H.R. 5554 also would
require the FDA to publish guidance or produce regulations on a
range of topics, transmit a report to the Congress, and hold
public meetings. CBO expects that the costs associated with
those activities would not be covered by fees, and it estimates
that implementing such provisions would cost $6 million over
the 2019-2023 period.
H.R. 5582, the Abuse Deterrent Access Act of 2018, would
require the Secretary of HHS to report to the Congress on
existing barriers to access to ``abuse-deterrent opioid
formulations'' by Medicare Part C and D beneficiaries. Such
formulations make the drugs more difficult to dissolve for
injection, for example, and thus can impede their abuse.
Assuming the availability of appropriated funds and based on
historical spending patterns for similar activities, CBO
estimates that implementing the legislation would cost less
than $500,000 over the 2019-2023 period.
H.R. 5590, the Opioid Addiction Action Plan Act, would
require the Secretary of HHS to develop an action plan by
January 1, 2019, for increasing access to medication-assisted
treatment among Medicare and Medicaid enrollees. The bill also
would require HHS to convene a stakeholder meeting and issue a
request for information within three months of enactment, and
to submit a report to the Congress by June 1, 2019. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5590 would cost approximately
$2 million over the 2019-2023 period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
FDA to require certain packaging and disposal technologies,
controls, or measures to mitigate the risk of abuse and misuse
of drugs. Based on information from the FDA, CBO estimates that
implementing H.R. 5687 would not significantly affect spending
over the 2019-2023 period. This bill would also require that
the GAO study the effectiveness and use of packaging
technologies for controlled substances--a provision that CBO
estimates would cost less than $500,000.
H.R. 5715, the Strengthening Partnerships to Prevent Opioid
Abuse Act, would require the Secretary of HHS to establish a
secure Internet portal to allow HHS, Medicare Advantage plans,
and Medicare Part D plans to exchange information about fraud,
waste, and abuse among providers and suppliers no later than
two years after enactment. H.R. 5715 also would require
organizations with Medicare Advantage contracts to submit
information on investigations related to providers suspected of
prescribing large volumes of opioids through a process
established by the Secretary no later than January 2021. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5715 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5789, a bill to require the Secretary of Health and
Human Services to issue guidance to improve care for infants
with neonatal abstinence syndrome and their mothers, and to
require the Comptroller General of the United States to conduct
a study on gaps in Medicaid coverage for pregnant and
postpartum women with substance use disorder, would direct the
Secretary of HHS to issue guidance to states on best practices
under Medicaid and CHIP for treating infants with neonatal
abstinence syndrome. H.R. 5789 also would direct the Government
Accountability Office to study Medicaid coverage for pregnant
and postpartum women with substance use disorders. Based on
information from HHS and historical spending patterns for
similar activities, CBO estimates that enacting H.R. 5789 would
cost approximately $2 million over the 2019-2023 period.
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would amend the Public Health Service Act so that requirements
pertaining to the confidentiality and disclosure of medical
records relating to substance use disorders align with the
provisions of the Health Insurance Portability and
Accountability Act of 1996. The bill would require the Office
of the Secretary of HHS to issue regulations prohibiting
discrimination based on data disclosed from such medical
records, to issue regulations requiring covered entities to
provide written notice of privacy practices, and to develop
model training programs and materials for health care providers
and patients and their families. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 5795
would cost approximately $1 million over the 2019-2023 period.
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct
the Medicaid and CHIP Payment and Access Commission to study
institutions for mental diseases in a representative sample of
states. Based on information from the commission about the cost
of similar work, CBO estimates that implementing H.R. 5800
would cost about $1 million over the 2019-2023 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers. The bill also would mandate two studies of Medicare
coding and payments arising from enactment of this legislation.
Based on the cost of similar activities, CBO estimates that
those reports would cost $1 million over the 2019-2023 period.
(If enacted, H.R. 5804 also would affect mandatory spending;
see Table 1.)
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would allow the FDA to require that pharmaceutical
manufacturers study certain drugs after they are approved to
assess any potential reduction in those drugs' effectiveness
for the conditions of use prescribed, recommended, or suggested
in labeling. CBO anticipates that implementing H.R. 5811 would
not significantly affect the FDA's costs over the 2019-2023
period.
Other Authorizations. The following nine bills would
increase authorization levels, but CBO has not completed
estimates of amounts. All authorizations would be subject to
future appropriation action.
H.R. 4284, Indexing Narcotics, Fentanyl, and
Opioids Act of 2017
H.R. 5002, Advancing Cutting Edge Research
Act
H.R. 5228, Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act (see Table
1 for an estimate of the revenue effects of H.R. 5228)
H.R. 5752, Stop Illicit Drug Importation Act
of 2018 (see Table 1 for an estimate of the revenue
effects of H.R. 5752)
H.R. 5799, Medicaid DRUG Improvement Act
(see Table 1 for an estimate of the direct spending
effects of H.R. 5799)
H.R. 5801, Medicaid Providers and
Pharmacists Are Required to Note Experiences in Record
Systems to Help In-Need Patients (PARTNERSHIP) Act (see
Table 1 for an estimate of the direct spending effects
of H.R. 5801)
H.R. 5806, 21st Century Tools for Pain and
Addiction Treatments Act
H.R. 5808, Medicaid Pharmaceutical Home Act
of 2018 (see Table 1 for an estimate of the direct
spending effects of H.R. 5808)
H.R. 5812, Creating Opportunities that
Necessitate New and Enhanced Connections That Improve
Opioid Navigation Strategies Act (CONNECTIONS) Act
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. Twenty-two of the bills discussed in this document
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending
and revenues in those bills can be found in Table 1.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 4998, the Health Insurance for
Former Foster Youth Act, would increase net direct spending by
more than $2.5 billion and on-budget deficits by more than $5
billion in at least one of the four consecutive 10-year periods
beginning in 2029.
CBO estimates that none of the remaining 58 bills included
in this estimate would increase net direct spending by more
than $2.5 billion or on-budget deficits by more than $5 billion
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: One of the 59 bills included in this document,
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the
costs of that bill's mandates on public and private entities
would fall below UMRA's thresholds ($80 million and $160
million, respectively, for public- and private-sector entities
in 2018, adjusted annually for inflation).
In addition, five bills would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of those bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would fall below the UMRA threshold. Because CBO
does not know how federal agencies would implement new
authority granted in the other two of those five bills, H.R.
5228 and 5687, CBO cannot determine whether the costs of their
mandates would exceed the threshold.
For large entitlement grant programs, including Medicaid
and CHIP, UMRA defines an increase in the stringency of
conditions on states or localities as an intergovernmental
mandate if the affected governments lack authority to offset
those costs while continuing to provide required services.
Because states possess significant flexibility to alter their
responsibilities within Medicaid and CHIP, the requirements
imposed by various bills in the markup on state administration
of those programs would not constitute mandates as defined in
UMRA.
Mandates Affecting Public and Private Entities
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would impose intergovernmental and private-sector mandates by
requiring entities that provide treatment for substance use
disorders to notify patients of their privacy rights and also
to notify patients in the event that the confidentiality of
their records is breached. In certain circumstances, H.R. 5795
also would prohibit public and private entities from denying
entry to treatment on the basis of information in patient
health records. Those requirements would either supplant or
narrowly expand responsibilities under existing law, and
compliance with them would not impose significant additional
costs. CBO estimates that the costs of the mandates would fall
below the annual thresholds established in UMRA.
Mandates Affecting Private Entities
Five bills included in this document would impose private-
sector mandates:
H.R. 5228, the Stop Counterfeit Drugs by Regulating and
Enhancing Enforcement Now Act, would require drug distributors
to cease distributing any drug that the Secretary of HHS
determines might present an imminent or substantial hazard to
public health. CBO cannot determine what drugs could be subject
to such an order nor can it determine how private entities
would respond. Consequently, CBO cannot determine whether the
aggregate cost of the mandate would exceed the annual threshold
for private-sector mandates.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would require developers
and manufacturers of OTC drugs to pay certain fees to the FDA.
CBO estimates that about $30 million would be collected each
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual
threshold for private-sector mandates in any year during that
period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would require developers and manufacturers
of brand-name and generic veterinary drugs to pay application,
product, establishment, and sponsor fees to the FDA. CBO
estimates that about $51 million would be collected annually,
on average, for a total of $257 million over the 2019-2023
period. Those amounts would not exceed the annual threshold for
private-sector mandates in any year during that period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
Secretary of HHS to require drug developers and manufacturers
to implement new packaging and disposal technology for certain
drugs. Based on information from the agency, CBO expects that
the Secretary would use the new regulatory authority provided
in the bill; however, it is uncertain how or when those
requirements would be implemented. Consequently, CBO cannot
determine whether the aggregate cost of the mandate would
exceed the annual threshold for private entities.
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would expand an existing mandate that requires drug developers
to conduct postapproval studies or clinical trials for certain
drugs. Under current law, in certain instances, the FDA can
require studies or clinical trials after a drug has been
approved. H.R. 5811 would permit the FDA to use that authority
if the reduction in a drug's effectiveness meant that its
benefits no longer outweighed its costs. CBO estimates that the
incremental cost of the mandate would fall below the annual
threshold established in UMRA because of the small number of
drugs affected and the narrow expansion of the authority that
exists under current law.
None of the remaining 53 bills included in this document
would impose an intergovernmental or private-sector mandate.
Previous CBO estimate: On June 6, 2018, CBO issued an
estimate for seven opioid-related bills ordered reported by the
House Committee on Ways and Means on May 16, 2018. Two of those
bills contain provisions that are identical or similar to the
legislation ordered reported by the Committee on Energy and
Commerce, and for those provisions, CBO's estimates are the
same.
In particular, five bills listed in this estimate contain
provisions that are identical or similar to those in several
sections of H.R. 5773, the Preventing Addiction for Susceptible
Seniors Act of 2018:
H.R. 5675, which would require prescription drug
plans to implement drug management programs, is identical to
section 2 of H.R. 5773.
H.R. 4841, regarding electronic prior
authorization for prescriptions under Medicare's Part D, is
similar to section 3 of H.R. 5773.
H.R. 5715, which would mandate the creation of a
new Internet portal to allow various stakeholders to exchange
information, is identical to section 4 of H.R. 5773.
H.R. 5684, which would expand medication therapy
management, is the same as section 5 of H.R. 5773.
H.R. 5716, regarding prescriber notification, is
identical to section 6 of H.R. 5773.
In addition, in this estimate, a provision related to
Medicare beneficiary education in H.R. 5686, the Medicare Clear
Health Options in Care for Enrollees Act of 2018, is the same
as a provision in section 2 of H.R. 5775, the Providing
Reliable Options for Patients and Educational Resources Act of
2018, in CBO's estimate for the Committee on Ways and Means.
Estimate prepared by: Federal Costs: Rebecca Yip (Centers
for Disease Control and Prevention), Mark Grabowicz (Drug
Enforcement Agency), Julia Christensen, Ellen Werble (Food and
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee,
Rebecca Yip (Medicare), Philippa Haven (National Institutes of
Health), Alice Burns, Andrea Noda (Office of the Secretary of
the Department of Health and Human Services), Philippa Haven,
Lori Housman, Emily King (Substance Abuse and Mental Health
Services Administration, Health Resources and Services
Administration); Federal Revenues: Jacob Fabian, Peter Huether,
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate
Kelly; Mandates: Andrew Laughlin.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates
Unit; Sarah Masi, Special Assistant for Health; Susan Willie,
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for
Budget Analysis; Theresa A. Gullo, Assistant Director for
Budget Analysis.
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.
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
authorize a demonstration project to expand treatment capacity
of current and new Medicaid providers.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5477 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.
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.
Earmark, 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. 5477 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Disclosure of Directed Rule Makings
Pursuant to section 3(i) of H.Res. 5, the Committee finds
that H.R. 5477 contains no directed rule makings.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
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.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides that the Act may be cited as the ``Rural
Development of Opioid Capacity Services Act'' or the ``Rural
DOCS Act.''
Section 2. Demonstration project to increase substance use provider
capacity under the Medicaid Program
Section 2 amends section 1903 of the Social Security Act.
Section 2 authorizes a demonstration project to expand
treatment capacity of current and new Medicaid providers
through expanding technical assistance to Medicaid providers
for Medicaid billing and substance use disorder education and
allowing states to receive enhanced matching dollars to raise
reimbursement rates for providers delivering SUD services.
Section 2 includes planning grants for at least ten states to
develop applications for the demonstration project and recruit
prospective Medicaid providers.
Section 2 allows for five states to participate in the
demonstration and receive an enhanced FMAP. These five states
would be eligible to receive an 80 percent match for new
spending on activities in the demonstration.
Finally, section 2 requires the states and CMS to conduct
robust evaluations of the demonstrations and requires a report
detailing best practices.
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 (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
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
(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, and
(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); 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
(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, 2019 (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 2019 and 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 2019; 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).
(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
(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 section,
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 5-year
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 42-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;
(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) 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 42-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
received 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 subparagraphs (C)
and (D), 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
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 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
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.
(D) Conditions.--In the case of a State
selected under paragraph (4) that provides
substance use disorder treatment and recovery
services under a waiver under section 1115,
such State shall, as a condition of receiving
payments under subparagraph (A)--
(i) coordinate such services under
such waiver with substance use disorder
treatment and recovery services
provided under the demonstration
project under this subsection; and
(ii) take such actions as appropriate
under the demonstration project to
expand such services under such waiver.
(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 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 three years
after the date of the enactment of this
subsection, the Director of the Agency for
Healthcare Research and Quality 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.
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