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115th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 115-723
======================================================================
INDIVIDUALS IN MEDICAID DESERVE CARE THAT IS APPROPRIATE AND
RESPONSIBLE IN ITS EXECUTION 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
together with
DISSENTING VIEWS
[To accompany H.R. 5797]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5797) to amend title XIX of the Social Security
Act to allow States to provide under Medicaid services for
certain individuals with opioid use disorders in institutions
for mental diseases, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Action................................................. 6
Committee Votes.................................................. 6
Oversight Findings and Recommendations........................... 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 7
Congressional Budget Office Estimate............................. 7
Federal Mandates Statement....................................... 28
Statement of General Performance Goals and Objectives............ 28
Duplication of Federal Programs.................................. 28
Committee Cost Estimate.......................................... 28
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 29
Disclosure of Directed Rule Makings.............................. 29
Advisory Committee Statement..................................... 29
Applicability to Legislative Branch.............................. 29
Section-by-Section Analysis of the Legislation................... 29
Changes in Existing Law Made by the Bill, as Reported............ 29
Dissenting Views................................................. 58
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 ``Individuals in Medicaid Deserve Care
that is Appropriate and Responsible in its Execution Act'' or the ``IMD
CARE Act''.
SEC. 2. MEDICAID STATE PLAN OPTION TO PROVIDE SERVICES FOR CERTAIN
INDIVIDUALS WITH OPIOID USE DISORDERS IN
INSTITUTIONS FOR MENTAL DISEASES.
Section 1915 of the Social Security Act (42 U.S.C. 1396n) is amended
by adding at the end the following new subsection:
``(l) State Plan Option To Provide Services for Certain Individuals
in Institutions for Mental Diseases.--
``(1) In general.--With respect to calendar quarters
beginning during the period beginning January 1, 2019, and
ending December 31, 2023, a State may elect, through a State
plan amendment, to, notwithstanding section 1905(a), provide
medical assistance for services furnished in institutions for
mental diseases and for other medically necessary services
furnished to eligible individuals with opioid use disorders, in
accordance with the requirements of this subsection.
``(2) Payments.--
``(A) In general.--Amounts expended under a State
plan amendment under paragraph (1) for services
described in such paragraph furnished, with respect to
a 12-month period, to an eligible individual with an
opioid use disorder who is a patient in an institution
for mental diseases shall be treated as medical
assistance for which payment is made under section
1903(a) but only to the extent that such services are
furnished for not more than a period of 30 days
(whether or not consecutive) during such 12-month
period.
``(B) Clarification.--Payment made under this
paragraph for expenditures under a State plan amendment
under this subsection with respect to services
described in paragraph (1) furnished to an eligible
individual with an opioid use disorder shall not affect
payment that would otherwise be made under section
1903(a) for expenditures under the State plan (or
waiver of such plan) for medical assistance for such
individual.
``(3) Information required in state plan amendment.--
``(A) In general.--A State electing to provide
medical assistance pursuant to this subsection shall
include with the submission of the State plan amendment
under paragraph (1) to the Secretary--
``(i) a plan on how the State will improve
access to outpatient care during the period of
the State plan amendment, including a
description of--
``(I) the process by which eligible
individuals with opioid use disorders
will make the transition from receiving
inpatient services in an institution
for mental diseases to appropriate
outpatient care; and
``(II) the process the State will
undertake to ensure individuals with
opioid use disorder are provided care
in the most integrated setting
appropriate to the needs of the
individuals; and
``(ii) a description of how the State plan
amendment ensures an appropriate clinical
screening of eligible individuals with an
opioid use disorder, including assessments to
determine level of care and length of stay
recommendations based upon the multidimensional
assessment criteria of the American Society of
Addiction Medicine.
``(B) Report.--Not later than the sooner of December
31, 2024, or one year after the date of the termination
of a State plan amendment under this subsection, the
State shall submit to the Secretary a report that
includes at least--
``(i) the number of eligible individuals with
opioid use disorders who received services
pursuant to such State plan amendment;
``(ii) the length of the stay of each such
individual in an institution for mental
diseases; and
``(iii) the type of outpatient treatment,
including medication-assisted treatment, each
such individual received after being discharged
from such institution.
``(4) Definitions.--In this subsection:
``(A) Eligible individual with an opioid use
disorder.--The term `eligible individual with an opioid
use disorder' means an individual who--
``(i) with respect to a State, is enrolled
for medical assistance under the State plan (or
a waiver of such plan);
``(ii) is at least 21 years of age;
``(iii) has not attained 65 years of age; and
``(iv) has been diagnosed with at least one
opioid use disorder.
``(B) Institution for mental diseases.--The term
`institution for mental diseases' has the meaning given
such term in section 1905(i).
``(C) Opioid prescription pain reliever.--The term
`opioid prescription pain reliever' includes
hydrocodone products, oxycodone products, tramadol
products, codeine products, morphine products, fentanyl
products, buprenorphine products, oxymorphone products,
meperidine products, hydromorphone products, methadone,
and any other prescription pain reliever identified by
the Assistant Secretary for Mental Health and Substance
Use.
``(D) Opioid use disorder.--The term `opioid use
disorder' means a disorder that meets the criteria of
the Diagnostic and Statistical Manual of Mental
Disorders, 4th Edition (or a successor edition), for
heroin use disorder or pain reliever use disorder
(including with respect to opioid prescription pain
relievers).
``(E) Other medically necessary services.--The term
`other medically necessary services' means, with
respect to an eligible individual with an opioid use
disorder who is a patient in an institution for mental
diseases, items and services that are provided to such
individual outside of such institution to the extent
that such items and services would be treated as
medical assistance for such individual if such
individual were not a patient in such institution.''.
Purpose and Summary
H.R. 5797 was introduced on May 15, 2018, by Rep. Mimi
Walters (R-CA). The bill allows state Medicaid programs to
remove the Institutions for Mental Diseases (IMD) exclusion for
Medicaid beneficiaries aged 21 to 64 with an opioid use
disorder for fiscal years 2019 to 2023. This bill improves the
continuum of care by removing a barrier to care under current
law, so Medicaid would pay for up to 30 total days of care in
an IMD during a 12-month period and eligible individuals can
get the care they need.
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\
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.\8\
---------------------------------------------------------------------------
\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/
---------------------------------------------------------------------------
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.''\9\ 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).
---------------------------------------------------------------------------
\9\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 disorders 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.''\10\
---------------------------------------------------------------------------
\10\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.''\11\ 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.
---------------------------------------------------------------------------
\11\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.
---------------------------------------------------------------------------
However, as MACPAC noted, ``there are gaps in the continuum
of care, and states vary in the extent to which they cover
needed treatment.''\12\ One of the barriers to appropriate
treatment consistently identified by Medicaid directors and
health policy experts is a 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.''\13\ 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. The Medicaid IMD exclusion does not
allow 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.
This includes patients in residential substance use disorder
treatment facilities.\14\
---------------------------------------------------------------------------
\12\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.
\13\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.
\14\Centers for Medicare & Medicaid Services (CMS), U.S. Department
of Health and Human Services. 2015a. Letter to state Medicaid directors
from Vikki Wachino regarding ``New service delivery opportunities for
individuals with a substance use disorder.'' July 27, 2015. https://
www. medicaid.gov/federal-policy-guidance/downloads/ SMD15003.pdf.
---------------------------------------------------------------------------
Under the Medicaid statute, federal funding cannot be used
to finance care for Medicaid beneficiaries aged 21 to 64
receiving mental or substance use disorder care in a
residential facility that has more than 16 beds.\15\ When a
Medicaid-eligible individual is a patient in an IMD, he or she
cannot receive Medicaid coverage for services provided inside
or outside the IMD. The Medicaid IMD exclusion is one of the
few instances in the Medicaid program where federal financial
participation cannot be used for medically necessary and
otherwise covered services for a specific Medicaid enrollee
population receiving treatment in a specific setting.\16\
---------------------------------------------------------------------------
\15\Social Security Act 1905(a)(B).
\16\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.
---------------------------------------------------------------------------
The Centers for Medicare and Medicaid Services' (CMS) has
allowed for some administrative flexibility to this
prohibition, issuing regulatory guidance in 2016 that would
allow for IMD payment for up to fifteen days in any given
month. Additionally, in 2015 CMS authorized a new Section 1115
Demonstration Project pathway for SUD, allowing states to
receive FFP for IMD stays so long as certain other criteria are
met and as part of a full continuum of care. However, these
1115 waivers take significant time to approve as well as state
resources.
Committee Action
On April 11, 2018, the Subcommittee on Health held a
hearing on the discussion draft entitled ``Limited repeal of
the IMD Exclusion for adult Medicaid beneficiaries with
substance use disorder.'' 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 April 25, 2018, the Subcommittee on Health met in open
markup session and forwarded the discussion draft, without
amendment, to the full Committee by a record vote of 16 yeas
and 10 nays. On May 17, 2018, the full Committee on Energy and
Commerce met in open markup session and ordered H.R. 5797, 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. 5797 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. 5797 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 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 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 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 Opioid 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 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 the 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 -49 -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
periodd, 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 allow
state Medicaid programs to remove the Institutions for Mental
Diseases exclusion for Medicaid beneficiaries aged 21-64 with
an opioid use disorder.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5797 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. 5797 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. 5797 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
``Individuals in Medicaid Deserve Care that is Appropriate and
Responsible in its Delivery Act'' or the ``IMD CARE Act.''
Section 2. Medicaid state plan option to provide services for certain
individuals with opioid use disorders in institutions for
mental diseases
Section 2 amends section 1915 of the Social Security Act to
allow state Medicaid programs for fiscal years 2019 through
2023 to remove the IMD exclusion for Medicaid beneficiaries
aged 21 to 64 with an opioid use disorder through a state plan
amendment. Opioid use disorder is defined using the Diagnostic
and Statistical Manual of Mental Disorders 4th edition
definition and includes heroin, fentanyl, oxycodone, tramadol,
oxycodone, etc. Medicaid could pay for up to 30 total days of
care in an IMD during a 12-month period year.
Section 2 requires states to include in their state plan
amendment information on (1) how the state will improve access
to outpatient care during the state plan amendment period, (2)
the process for transitioning individuals to appropriate
outpatient care, (3) a description of how individuals will
receive appropriate screening and assessment. Finally, section
2 requires that within one year, states shall report on: (1)
number of individuals with opioid use disorder under this plan,
(2) length of stay, and (3) type of treatment received upon
discharge.
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
* * * * * * *
PROVISIONS RESPECTING INAPPLICABILITY AND WAIVER OF CERTAIN
REQUIREMENTS OF THIS TITLE
Sec. 1915. (a) A State shall not be deemed to be out of
compliance with the requirements of paragraphs (1), (10), or
(23) of section 1902(a) solely by reason of the fact that the
State (or any political subdivision thereof)--
(1) has entered into--
(A) a contract with an organization which has
agreed to provide care and services in addition
to those offered under the State plan to
individuals eligible for medical assistance who
reside in the geographic area served by such
organization and who elect to obtain such care
and services from such organization, or by
reason of the fact that the plan provides for
payment for rural health clinic services only
if those services are provided by a rural
health clinic; or
(B) arrangements through a competitive
bidding process or otherwise for the purchase
of laboratory services referred to in section
1905(a)(3) or medical devices if the Secretary
has found that--
(i) adequate services or devices will
be available under such arrangements,
and
(ii) any such laboratory services
will be provided only through
laboratories--
(I) which meet the applicable
requirements of section
1861(e)(9) or paragraphs (16)
and (17) of section 1861(s),
and such additional
requirements as the Secretary
may require, and
(II) no more than 75 percent
of whose charges for such
services are for services
provided to individuals who are
entitled to benefits under this
title or under part A or part B
of title XVIII; or
(2) restricts for a reasonable period of time the
provider or providers from which an individual
(eligible for medical assistance for items or services
under the State plan) can receive such items or
services, if--
(A) the State has found, after notice and
opportunity for a hearing (in accordance with
procedures established by the State), that the
individual has utilized such items or services
at a frequency or amount not medically
necessary (as determined in accordance with
utilization guidelines established by the
State), and
(B) under such restriction, individuals
eligible for medical assistance for such
services have reasonable access (taking into
account geographic location and reasonable
travel time) to such services of adequate
quality.
(b) The Secretary, to the extent he finds it to be cost-
effective and efficient and not inconsistent with the purposes
of this title, may waive such requirements of section 1902
(other than subsection (s)) (other than sections 1902(a)(15),
1902(bb), and 1902(a)(10)(A) insofar as it requires provision
of the care and services described in section 1905(a)(2)(C)) as
may be necessary for a State--
(1) to implement a primary care case-management
system or a specialty physician services arrangement
which restricts the provider from (or through) whom an
individual (eligible for medical assistance under this
title) can obtain medical care services (other than in
emergency circumstances), if such restriction does not
substantially impair access to such services of
adequate quality where medically necessary,
(2) to allow a locality to act as a central broker in
assisting individuals (eligible for medical assistance
under this title) in selecting among competing health
care plans, if such restriction does not substantially
impair access to services of adequate quality where
medically necessary,
(3) to share (through provision of additional
services) with recipients of medical assistance under
the State plan cost savings resulting from use by the
recipient of more cost-effective medical care, and
(4) to restrict the provider from (or through) whom
an individual (eligible for medical assistance under
this title) can obtain services (other than in
emergency circumstances) to providers or practitioners
who undertake to provide such services and who meet,
accept, and comply with the reimbursement, quality, and
utilization standards under the State plan, which
standards shall be consistent with the requirements of
section 1923 and are consistent with access, quality,
and efficient and economic provision of covered care
and services, if such restriction does not discriminate
among classes of providers on grounds unrelated to
their demonstrated effectiveness and efficiency in
providing those services and if providers under such
restriction are paid on a timely basis in the same
manner as health care practitioners must be paid under
section 1902(a)(37)(A).
No waiver under this subsection may restrict the choice of the
individual in receiving services under section 1905(a)(4)(C).
Subsection (h)(2) shall apply to a waiver under this
subsection.
(c)(1) The Secretary may by waiver provide that a State plan
approved under this title may include as ``medical assistance''
under such plan payment for part or all of the cost of home or
community-based services (other than room and board) approved
by the Secretary which are provided pursuant to a written plan
of care to individuals with respect to whom there has been a
determination that but for the provision of such services the
individuals would require the level of care provided in a
hospital or a nursing facility or intermediate care facility
for the mentally retarded the cost of which could be reimbursed
under the State plan. For purposes of this subsection, the term
``room and board'' shall not include an amount established
under a method determined by the State to reflect the portion
of costs of rent and food attributable to an unrelated personal
caregiver who is residing in the same household with an
individual who, but for the assistance of such caregiver, would
require admission to a hospital, nursing facility, or
intermediate care facility for the mentally retarded.
(2) A waiver shall not be granted under this subsection
unless the State provides assurances satisfactory to the
Secretary that--
(A) necessary safeguards (including adequate
standards for provider participation) have been taken
to protect the health and welfare of individuals
provided services under the waiver and to assure
financial accountability for funds expended with
respect to such services;
(B) the State will provide, with respect to
individuals who--
(i) are entitled to medical assistance for
inpatient hospital services, nursing facility
services, or services in an intermediate care
facility for the mentally retarded under the
State plan,
(ii) may require such services, and
(iii) may be eligible for such home or
community-based care under such waiver,
for an evaluation of the need for inpatient hospital
services, nursing facility services, or services in an
intermediate care facility for the mentally retarded;
(C) such individuals who are determined to be likely
to require the level of care provided in a hospital,
nursing facility, or intermediate care facility for the
mentally retarded are informed of the feasible
alternatives, if available under the waiver, at the
choice of such individuals, to the provision of
inpatient hospital services, nursing facility services,
or services in an intermediate care facility for the
mentally retarded;
(D) under such waiver the average per capita
expenditure estimated by the State in any fiscal year
for medical assistance provided with respect to such
individuals does not exceed 100 percent of the average
per capita expenditure that the State reasonably
estimates would have been made in that fiscal year for
expenditures under the State plan for such individuals
if the waiver had not been granted; and
(E) the State will provide to the Secretary annually,
consistent with a data collection plan designed by the
Secretary, information on the impact of the waiver
granted under this subsection on the type and amount of
medical assistance provided under the State plan and on
the health and welfare of recipients.
(3) A waiver granted under this subsection may include a
waiver of the requirements of section 1902(a)(1) (relating to
statewideness), section 1902(a)(10)(B) (relating to
comparability), and section 1902(a)(10)(C)(i)(III) (relating to
income and resource rules applicable in the community). A
waiver under this subsection (other than a waiver described in
subsection (h)(2)) shall be for an initial term of three years
and, upon the request of a State, shall be extended for
additional five-year periods unless the Secretary determines
that for the previous waiver period the assurances provided
under paragraph (2) have not been met. A waiver may provide,
with respect to post-eligibility treatment of income of all
individuals receiving services under that waiver, that the
maximum amount of the individual's income which may be
disregarded for any month for the maintenance needs of the
individual may be an amount greater than the maximum allowed
for that purpose under regulations in effect on July 1, 1985.
(4) A waiver granted under this subsection may, consistent
with paragraph (2)--
(A) limit the individuals provided benefits under
such waiver to individuals with respect to whom the
State has determined that there is a reasonable
expectation that the amount of medical assistance
provided with respect to the individual under such
waiver will not exceed the amount of such medical
assistance provided for such individual if the waiver
did not apply, and
(B) provide medical assistance to individuals (to the
extent consistent with written plans of care, which are
subject to the approval of the State) for case
management services, homemaker/home health aide
services and personal care services, adult day health
services, habilitation services, respite care, and such
other services requested by the State as the Secretary
may approve and for day treatment or other partial
hospitalization services, psychosocial rehabilitation
services, and clinic services (whether or not furnished
in a facility) for individuals with chronic mental
illness.
Except as provided under paragraph (2)(D), the Secretary may
not restrict the number of hours or days of respite care in any
period which a State may provide under a waiver under this
subsection.
(5) For purposes of paragraph (4)(B), the term ``habilitation
services''--
(A) means services designed to assist individuals in
acquiring, retaining, and improving the self-help,
socialization, and adaptive skills necessary to reside
successfully in home and community based settings; and
(B) includes (except as provided in subparagraph (C))
prevocational, educational, and supported employment
services; but
(C) does not include--
(i) special education and related services
(as such terms are defined in section 602 of
the Individuals with Disabilities Education Act
(20 U.S.C. 1401)) which otherwise are available
to the individual through a local educational
agency; and
(ii) vocational rehabilitation services which
otherwise are available to the individual
through a program funded under section 110 of
the Rehabilitation Act of 1973 (29 U.S.C. 730).
(6) The Secretary may not require, as a condition of approval
of a waiver under this section under paragraph (2)(D), that the
actual total expenditures for home and community-based services
under the waiver (and a claim for Federal financial
participation in expenditures for the services) cannot exceed
the approved estimates for these services. The Secretary may
not deny Federal financial payment with respect to services
under such a waiver on the ground that, in order to comply with
paragraph (2)(D), a State has failed to comply with such a
requirement.
(7)(A) In making estimates under paragraph (2)(D) in the case
of a waiver that applies only to individuals with a particular
illness or condition who are inpatients in, or who would
require the level of care provided in, hospitals, nursing
facilities, or intermediate care facilities for the mentally
retarded, the State may determine the average per capita
expenditure that would have been made in a fiscal year for
those individuals under the State plan separately from the
expenditures for other individuals who are inpatients in, or
who would require the level of care provided in, those
respective facilities.
(B) In making estimates under paragraph (2)(D) in the case of
a waiver that applies only to individuals with developmental
disabilities who are inpatients in a nursing facility and whom
the State has determined, on the basis of an evaluation under
paragraph (2)(B), to need the level of services provided by an
intermediate care facility for the mentally retarded, the State
may determine the average per capita expenditures that would
have been made in a fiscal year for those individuals under the
State plan on the basis of the average per capita expenditures
under the State plan for services to individuals who are
inpatients in an intermediate care facility for the mentally
retarded, without regard to the availability of beds for such
inpatients.
(C) In making estimates under paragraph (2)(D) in the case of
a waiver to the extent that it applies to individuals with
mental retardation or a related condition who are resident in
an intermediate care facility for the mentally retarded the
participation of which under the State plan is terminated, the
State may determine the average per capita expenditures that
would have been made in a fiscal year for those individuals
without regard to any such termination.
(8) The State agency administering the plan under this title
may, whenever appropriate, enter into cooperative arrangements
with the State agency responsible for administering the program
for children with special health care needs under title V in
order to assure improved access to coordinated services to meet
the needs of such children.
(9) In the case of any waiver under this subsection which
contains a limit on the number of individuals who shall receive
home or community-based services, the State may substitute
additional individuals to receive such services to replace any
individuals who die or become ineligible for services under the
State plan.
(10) The Secretary shall not limit to fewer than 200 the
number of individuals in the State who may receive home and
community-based services under a waiver under this subsection.
(d)(1) Subject to paragraph (2), the Secretary shall grant a
waiver to provide that a State plan approved under this title
shall include as ``medical assistance'' under such plan payment
for part or all of the cost of home or community-based services
(other than room and board) which are provided pursuant to a
written plan of care to individuals 65 years of age or older
with respect to whom there has been a determination that but
for the provision of such services the individuals would be
likely to require the level of care provided in a skilled
nursing facility or intermediate care facility the cost of
which could be reimbursed under the State plan. For purposes of
this subsection, the term ``room and board'' shall not include
an amount established under a method determined by the State to
reflect the portion of costs of rent and food attributable to
an unrelated personal caregiver who is residing in the same
household with an individual who, but for the assistance of
such caregiver, would require admission to a hospital, nursing
facility, or intermediate care facility for the mentally
retarded.
(2) A waiver shall not be granted under this subsection
unless the State provides assurances satisfactory to the
Secretary that--
(A) necessary safeguards (including adequate
standards for provider participation) have been taken
to protect the health and welfare of individuals
provided services under the waiver and to assure
financial accountability for funds expended with
respect to such services;
(B) with respect to individuals 65 years of age or
older who--
(i) are entitled to medical assistance for
skilled nursing or intermediate care facility
services under the State plan,
(ii) may require such services, and
(iii) may be eligible for such home or
community-based services under such waiver,
the State will provide for an evaluation of the need
for such skilled nursing facility or intermediate care
facility services; and
(C) such individuals who are determined to be likely
to require the level of care provided in a skilled
nursing facility or intermediate care facility are
informed of the feasible alternatives to the provision
of skilled nursing facility or intermediate care
facility services, which such individuals may choose if
available under the waiver.
Each State with a waiver under this subsection shall provide to
the Secretary annually, consistent with a reasonable data
collection plan designed by the Secretary, information on the
impact of the waiver granted under this subsection on the type
and amount of medical assistance provided under the State plan
and on the health and welfare of recipients.
(3) A waiver granted under this subsection may include a
waiver of the requirements of section 1902(a)(1) (relating to
statewideness), section 1902(a)(10)(B) (relating to
comparability), and section 1902(a)(10)(C)(i)(III) (relating to
income and resource rules applicable in the community). Subject
to a termination by the State (with notice to the Secretary) at
any time, a waiver under this subsection (other than a waiver
described in subsection (h)(2)) shall be for an initial term of
3 years and, upon the request of a State, shall be extended for
additional 5-year periods unless the Secretary determines that
for the previous waiver period the assurances provided under
paragraph (2) have not been met. A waiver may provide, with
respect to post-eligibility treatment of income of all
individuals receiving services under the waiver, that the
maximum amount of the individual's income which may be
disregarded for any month is equal to the amount that may be
allowed for that purpose under a waiver under subsection (c).
(4) A waiver under this subsection may, consistent with
paragraph (2), provide medical assistance to individuals for
case management services, homemaker/home health aide services
and personal care services, adult day health services, respite
care, and other medical and social services that can contribute
to the health and well-being of individuals and their ability
to reside in a community-based care setting.
(5)(A) In the case of a State having a waiver approved under
this subsection, notwithstanding any other provision of section
1903 to the contrary, the total amount expended by the State
for medical assistance with respect to skilled nursing facility
services, intermediate care facility services, and home and
community-based services under the State plan for individuals
65 years of age or older during a waiver year under this
subsection may not exceed the projected amount determined under
subparagraph (B).
(B) For purposes of subparagraph (A), the projected amount
under this subparagraph is the sum of the following:
(i) The aggregate amount of the State's medical
assistance under this title for skilled nursing
facility services and intermediate care facility
services furnished to individuals who have attained the
age of 65 for the base year increased by a percentage
which is equal to the lesser of 7 percent times the
number of years (rounded to the nearest quarter of a
year) beginning after the base year and ending at the
end of the waiver year involved or the sum of--
(I) the percentage increase (based on an
appropriate market-basket index representing
the costs of elements of such services) between
the beginning of the base year and the
beginning of the waiver year involved, plus
(II) the percentage increase between the
beginning of the base year and the beginning of
the waiver year involved in the number of
residents in the State who have attained the
age of 65, plus
(III) 2 percent for each year (rounded to the
nearest quarter of a year) beginning after the
base year and ending at the end of the waiver
year.
(ii) The aggregate amount of the State's medical
assistance under this title for home and community-
based services for individuals who have attained the
age of 65 for the base year increased by a percentage
which is equal to the lesser of 7 percent times the
number of years (rounded to the nearest quarter of a
year) beginning after the base year and ending at the
end of the waiver year involved or the sum of--
(I) the percentage increase (based on an
appropriate market-basket index representing
the costs of elements of such services) between
the beginning of the base year and the
beginning of the waiver year involved, plus
(II) the percentage increase between the
beginning of the base year and the beginning of
the waiver year involved in the number of
residents in the State who have attained the
age of 65, plus
(III) 2 percent for each year (rounded to the
nearest quarter of a year) beginning after the
base year and ending at the end of the waiver
year.
(iii) The Secretary shall develop and promulgate by
regulation (by not later than October 1, 1989)--
(I) a method, based on an index of appropriately
weighted indicators of changes in the wages and prices
of the mix of goods and services which comprise both
skilled nursing facility services and intermediate care
facility services (regardless of the source of payment
for such services), for projecting the percentage
increase for purposes of clause (i)(I);
(II) a method, based on an index of appropriately
weighted indicators of changes in the wages and prices
of the mix of goods and services which comprise home
and community-based services (regardless of the source
of payment for such services), for projecting the
percentage increase for purposes of clause (ii)(I); and
(III) a method for projecting, on a State specific
basis, the percentage increase in the number of
residents in each State who are over 65 years of age
for any period.
The Secretary shall develop (by not later than October 1, 1989)
a method for projecting, on a State-specific basis, the
percentage increase in the number of residents in each State
who are over 65 years of age for any period. Effective on and
after the date the Secretary promulgates the regulation under
clause (iii), any reference in this subparagraph to the
``lesser of 7 percent'' shall be deemed to be a reference to
the ``greater of 7 percent''.
(iv) If there is enacted after December 22, 1987, an Act
which amends this title whose provisions become effective on or
after such date and which results in an increase in the
aggregate amount of medical assistance under this title for
nursing facility services and home and community-based services
for individuals who have attained the age of 65 years, the
Secretary, at the request of a State with a waiver under this
subsection for a waiver year or years and in close consultation
with the State, shall adjust the projected amount computed
under this subparagraph for the waiver year or years to take
into account such increase.
(C) In this paragraph:
(i) The term ``home and community-based services''
includes services described in sections 1905(a)(7) and
1905(a)(8), services described in subsection (c)(4)(B),
services described in paragraph (4), and personal care
services.
(ii)(I) Subject to subclause (II), the term ``base
year'' means the most recent year (ending before the
date of the enactment of this subsection) for which
actual final expenditures under this title have been
reported to, and accepted by, the Secretary.
(II) For purposes of subparagraph (C), in the case of
a State that does not report expenditures on the basis
of the age categories described in such subparagraph
for a year ending before the date of the enactment of
this subsection, the term ``base year'' means fiscal
year 1989.
(iii) The term ``intermediate care facility
services'' does not include services furnished in an
institution certified in accordance with section
1905(d).
(6)(A) A determination by the Secretary to deny a request for
a waiver (or extension of waiver) under this subsection shall
be subject to review to the extent provided under section
1116(b).
(B) Notwithstanding any other provision of this Act, if the
Secretary denies a request of the State for an extension of a
waiver under this subsection, any waiver under this subsection
in effect on the date such request is made shall remain in
effect for a period of not less than 90 days after the date on
which the Secretary denies such request (or, if the State seeks
review of such determination in accordance with subparagraph
(A), the date on which a final determination is made with
respect to such review).
(e)(1)(A) Subject to paragraph (2), the Secretary shall grant
a waiver to provide that a State plan approved under this title
shall include as ``medical assistance'' under such plan payment
for part or all of the cost of nursing care, respite care,
physicians' services, prescribed drugs, medical devices and
supplies, transportation services, and such other services
requested by the State as the Secretary may approve which are
provided pursuant to a written plan of care to a child
described in subparagraph (B) with respect to whom there has
been a determination that but for the provision of such
services the infants would be likely to require the level of
care provided in a hospital or nursing facility the cost of
which could be reimbursed under the State plan.
(B) Children described in this subparagraph are individuals
under 5 years of age who--
(i) at the time of birth were infected with (or
tested positively for) the etiologic agent for acquired
immune deficiency syndrome (AIDS),
(ii) have such syndrome, or
(iii) at the time of birth were dependent on heroin,
cocaine, or phencyclidine,
and with respect to whom adoption or foster care assistance is
(or will be) made available under part E of title IV.
(2) A waiver shall not be granted under this subsection
unless the State provides assurances satisfactory to the
Secretary that--
(A) necessary safeguards (including adequate
standards for provider participation) have been taken
to protect the health and welfare of individuals
provided services under the waiver and to assure
financial accountability for funds expended with
respect to such services;
(B) under such waiver the average per capita
expenditure estimated by the State in any fiscal year
for medical assistance provided with respect to such
individuals does not exceed 100 percent of the average
per capita expenditure that the State reasonably
estimates would have been made in that fiscal year for
expenditures under the State plan for such individuals
if the waiver had not been granted; and
(C) the State will provide to the Secretary annually,
consistent with a data collection plan designed by the
Secretary, information on the impact of the waiver
granted under this subsection on the type and amount of
medical assistance provided under the State plan and on
the health and welfare of recipients.
(3) A waiver granted under this subsection may include a
waiver of the requirements of section 1902(a)(1) (relating to
statewideness) and section 1902(a)(10)(B) (relating to
comparability). A waiver under this subsection shall be for an
initial term of 3 years and, upon the request of a State, shall
be extended for additional five-year periods unless the
Secretary determines that for the previous waiver period the
assurances provided under paragraph (2) have not been met.
(4) The provisions of paragraph (6) of subsection (d) shall
apply to this subsection in the same manner as it applies to
subsection (d).
(f)(1) The Secretary shall monitor the implementation of
waivers granted under this section to assure that the
requirements for such waiver are being met and shall, after
notice and opportunity for a hearing, terminate any such waiver
where he finds noncompliance has occurred.
(2) A request to the Secretary from a State for approval of a
proposed State plan or plan amendment or a waiver of a
requirement of this title submitted by the State pursuant to a
provision of this title shall be deemed granted unless the
Secretary, within 90 days after the date of its submission to
the Secretary, either denies such request in writing or informs
the State agency in writing with respect to any additional
information which is needed in order to make a final
determination with respect to the request. After the date the
Secretary receives such additional information, the request
shall be deemed granted unless the Secretary, within 90 days of
such date, denies such request.
(g)(1) A State may provide, as medical assistance, case
management services under the plan without regard to the
requirements of section 1902(a)(1) and section 1902(a)(10)(B).
The provision of case management services under this subsection
shall not restrict the choice of the individual to receive
medical assistance in violation of section 1902(a)(23). A State
may limit the provision of case management services under this
subsection to individuals with acquired immune deficiency
syndrome (AIDS), or with AIDS-related conditions, or with
either, or to individuals described in section 1902(z)(1)(A)
and a State may limit the provision of case management services
under this subsection to individuals with chronic mental
illness. The State may limit the case managers available with
respect to case management services for eligible individuals
with developmental disabilities or with chronic mental illness
in order to ensure that the case managers for such individuals
are capable of ensuring that such individuals receive needed
services.
(2) For purposes of this subsection:
(A)(i) The term ``case management services'' means
services which will assist individuals eligible under
the plan in gaining access to needed medical, social,
educational, and other services.
(ii) Such term includes the following:
(I) Assessment of an eligible individual to
determine service needs, including activities
that focus on needs identification, to
determine the need for any medical,
educational, social, or other services. Such
assessment activities include the following:
(aa) Taking client history.
(bb) Identifying the needs of the
individual, and completing related
documentation.
(cc) Gathering information from other
sources such as family members, medical
providers, social workers, and
educators, if necessary, to form a
complete assessment of the eligible
individual.
(II) Development of a specific care plan
based on the information collected through an
assessment, that specifies the goals and
actions to address the medical, social,
educational, and other services needed by the
eligible individual, including activities such
as ensuring the active participation of the
eligible individual and working with the
individual (or the individual's authorized
health care decision maker) and others to
develop such goals and identify a course of
action to respond to the assessed needs of the
eligible individual.
(III) Referral and related activities to help
an individual obtain needed services, including
activities that help link eligible individuals
with medical, social, educational providers or
other programs and services that are capable of
providing needed services, such as making
referrals to providers for needed services and
scheduling appointments for the individual.
(IV) Monitoring and followup activities,
including activities and contacts that are
necessary to ensure the care plan is
effectively implemented and adequately
addressing the needs of the eligible
individual, and which may be with the
individual, family members, providers, or other
entities and conducted as frequently as
necessary to help determine such matters as--
(aa) whether services are being
furnished in accordance with an
individual's care plan;
(bb) whether the services in the care
plan are adequate; and
(cc) whether there are changes in the
needs or status of the eligible
individual, and if so, making necessary
adjustments in the care plan and
service arrangements with providers.
(iii) Such term does not include the direct delivery
of an underlying medical, educational, social, or other
service to which an eligible individual has been
referred, including, with respect to the direct
delivery of foster care services, services such as (but
not limited to) the following:
(I) Research gathering and completion of
documentation required by the foster care
program.
(II) Assessing adoption placements.
(III) Recruiting or interviewing potential
foster care parents.
(IV) Serving legal papers.
(V) Home investigations.
(VI) Providing transportation.
(VII) Administering foster care subsidies.
(VIII) Making placement arrangements.
(B) The term ``targeted case management services''
are case management services that are furnished without
regard to the requirements of section 1902(a)(1) and
section 1902(a)(10)(B) to specific classes of
individuals or to individuals who reside in specified
areas.
(3) With respect to contacts with individuals who are not
eligible for medical assistance under the State plan or, in the
case of targeted case management services, individuals who are
eligible for such assistance but are not part of the target
population specified in the State plan, such contacts--
(A) are considered an allowable case management
activity, when the purpose of the contact is directly
related to the management of the eligible individual's
care; and
(B) are not considered an allowable case management
activity if such contacts relate directly to the
identification and management of the noneligible or
nontargeted individual's needs and care.
(4)(A) In accordance with section 1902(a)(25), Federal
financial participation only is available under this title for
case management services or targeted case management services
if there are no other third parties liable to pay for such
services, including as reimbursement under a medical, social,
educational, or other program.
(B) A State shall allocate the costs of any part of such
services which are reimbursable under another federally funded
program in accordance with OMB Circular A-87 (or any related or
successor guidance or regulations regarding allocation of costs
among federally funded programs) under an approved cost
allocation program.
(5) Nothing in this subsection shall be construed as
affecting the application of rules with respect to third party
liability under programs, or activities carried out under title
XXVI of the Public Health Service Act or by the Indian Health
Service.
(h)(1) No waiver under this section (other than a waiver
under subsection (c), (d), or (e), or a waiver described in
paragraph (2)) may extend over a period of longer than two
years unless the State requests continuation of such waiver,
and such request shall be deemed granted unless the Secretary,
within 90 days after the date of its submission to the
Secretary, either denies such request in writing or informs the
State agency in writing with respect to any additional
information which is needed in order to make a final
determination with respect to the request. After the date the
Secretary receives such additional information, the request
shall be deemed granted unless the Secretary, within 90 days of
such date, denies such request.
(2)(A) Notwithstanding subsections (c)(3) and (d) (3), any
waiver under subsection (b), (c), or (d), or a waiver under
section 1115, that provides medical assistance for dual
eligible individuals (including any such waivers under which
non dual eligible individuals may be enrolled in addition to
dual eligible individuals) may be conducted for a period of 5
years and, upon the request of the State, may be extended for
additional 5-year periods unless the Secretary determines that
for the previous waiver period the conditions for the waiver
have not been met or it would no longer be cost-effective and
efficient, or consistent with the purposes of this title, to
extend the waiver.
(B) In this paragraph, the term ``dual eligible individual''
means an individual who is entitled to, or enrolled for,
benefits under part A of title XVIII, or enrolled for benefits
under part B of title XVIII, and is eligible for medical
assistance under the State plan under this title or under a
waiver of such plan.
(i) State Plan Amendment Option To Provide Home and
Community-Based Services for Elderly and Disabled
Individuals.--
(1) In general.--Subject to the succeeding provisions
of this subsection, a State may provide through a State
plan amendment for the provision of medical assistance
for home and community-based services (within the scope
of services described in paragraph (4)(B) of subsection
(c) for which the Secretary has the authority to
approve a waiver and not including room and board) for
individuals eligible for medical assistance under the
State plan whose income does not exceed 150 percent of
the poverty line (as defined in section 2110(c)(5)),
without determining that but for the provision of such
services the individuals would require the level of
care provided in a hospital or a nursing facility or
intermediate care facility for the mentally retarded,
but only if the State meets the following requirements:
(A) Needs-based criteria for eligibility for,
and receipt of, home and community-based
services.--The State establishes needs-based
criteria for determining an individual's
eligibility under the State plan for medical
assistance for such home and community-based
services, and if the individual is eligible for
such services, the specific home and community-
based services that the individual will
receive.
(B) Establishment of more stringent needs-
based eligibility criteria for
institutionalized care.--The State establishes
needs-based criteria for determining whether an
individual requires the level of care provided
in a hospital, a nursing facility, or an
intermediate care facility for the mentally
retarded under the State plan or under any
waiver of such plan that are more stringent
than the needs-based criteria established under
subparagraph (A) for determining eligibility
for home and community-based services.
(C) Projection of number of individuals to be
provided home and community-based services.--
The State submits to the Secretary, in such
form and manner, and upon such frequency as the
Secretary shall specify, the projected number
of individuals to be provided home and
community-based services.
(D) Criteria based on individual
assessment.--
(i) In general.--The criteria
established by the State for purposes
of subparagraphs (A) and (B) requires
an assessment of an individual's
support needs and capabilities, and may
take into account the inability of the
individual to perform 2 or more
activities of daily living (as defined
in section 7702B(c)(2)(B) of the
Internal Revenue Code of 1986) or the
need for significant assistance to
perform such activities, and such other
risk factors as the State determines to
be appropriate.
(ii) Adjustment authority.--The State
plan amendment provides the State with
the option to modify the criteria
established under subparagraph (A)
(without having to obtain prior
approval from the Secretary) in the
event that the enrollment of
individuals eligible for home and
community-based services exceeds the
projected enrollment submitted for
purposes of subparagraph (C), but only
if--
(I) the State provides at
least 60 days notice to the
Secretary and the public of the
proposed modification;
(II) the State deems an
individual receiving home and
community-based services on the
basis of the most recent
version of the criteria in
effect prior to the effective
date of the modification to
continue to be eligible for
such services after the
effective date of the
modification and until such
time as the individual no
longer meets the standard for
receipt of such services under
such pre-modified criteria; and
(III) after the effective
date of such modification, the
State, at a minimum, applies
the criteria for determining
whether an individual requires
the level of care provided in a
hospital, a nursing facility,
or an intermediate care
facility for the mentally
retarded under the State plan
or under any waiver of such
plan which applied prior to the
application of the more
stringent criteria developed
under subparagraph (B).
(E) Independent evaluation and assessment.--
(i) Eligibility determination.--The
State uses an independent evaluation
for making the determinations described
in subparagraphs (A) and (B).
(ii) Assessment.--In the case of an
individual who is determined to be
eligible for home and community-based
services, the State uses an independent
assessment, based on the needs of the
individual to--
(I) determine a necessary
level of services and supports
to be provided, consistent with
an individual's physical and
mental capacity;
(II) prevent the provision of
unnecessary or inappropriate
care; and
(III) establish an
individualized care plan for
the individual in accordance
with subparagraph (G).
(F) Assessment.--The independent assessment
required under subparagraph (E)(ii) shall
include the following:
(i) An objective evaluation of an
individual's inability to perform 2 or
more activities of daily living (as
defined in section 7702B(c)(2)(B) of
the Internal Revenue Code of 1986) or
the need for significant assistance to
perform such activities.
(ii) A face-to-face evaluation of the
individual by an individual trained in
the assessment and evaluation of
individuals whose physical or mental
conditions trigger a potential need for
home and community-based services.
(iii) Where appropriate, consultation
with the individual's family, spouse,
guardian, or other responsible
individual.
(iv) Consultation with appropriate
treating and consulting health and
support professionals caring for the
individual.
(v) An examination of the
individual's relevant history, medical
records, and care and support needs,
guided by best practices and research
on effective strategies that result in
improved health and quality of life
outcomes.
(vi) If the State offers individuals
the option to self-direct the purchase
of, or control the receipt of, home and
community-based service, an evaluation
of the ability of the individual or the
individual's representative to self-
direct the purchase of, or control the
receipt of, such services if the
individual so elects.
(G) Individualized care plan.--
(i) In general.--In the case of an
individual who is determined to be
eligible for home and community-based
services, the State uses the
independent assessment required under
subparagraph (E)(ii) to establish a
written individualized care plan for
the individual.
(ii) Plan requirements.--The State
ensures that the individualized care
plan for an individual--
(I) is developed--
(aa) in consultation
with the individual,
the individual's
treating physician,
health care or support
professional, or other
appropriate
individuals, as defined
by the State, and,
where appropriate the
individual's family,
caregiver, or
representative; and
(bb) taking into
account the extent of,
and need for, any
family or other
supports for the
individual;
(II) identifies the necessary
home and community-based
services to be furnished to the
individual (or, if the
individual elects to self-
direct the purchase of, or
control the receipt of, such
services, funded for the
individual); and
(III) is reviewed at least
annually and as needed when
there is a significant change
in the individual's
circumstances.
(iii) state option to offer election
for self-directed services.--
(I) Individual choice.--At
the option of the State, the
State may allow an individual
or the individual's
representative to elect to
receive self-directed home and
community-based services in a
manner which gives them the
most control over such services
consistent with the
individual's abilities and the
requirements of subclauses (II)
and (III).
(II) Self-directed
services.--The term ``self-
directed'' means, with respect
to the home and community-based
services offered under the
State plan amendment, such
services for the individual
which are planned and purchased
under the direction and control
of such individual or the
individual's authorized
representative, including the
amount, duration, scope,
provider, and location of such
services, under the State plan
consistent with the following
requirements:
(aa) Assessment.--
There is an assessment
of the needs,
capabilities, and
preferences of the
individual with respect
to such services.
(bb) Service plan.--
Based on such
assessment, there is
developed jointly with
such individual or the
individual's authorized
representative a plan
for such services for
such individual that is
approved by the State
and that satisfies the
requirements of
subclause (III).
(III) Plan requirements.--For
purposes of subclause (II)(bb),
the requirements of this
subclause are that the plan--
(aa) specifies those
services which the
individual or the
individual's authorized
representative would be
responsible for
directing;
(bb) identifies the
methods by which the
individual or the
individual's authorized
representative will
select, manage, and
dismiss providers of
such services;
(cc) specifies the
role of family members
and others whose
participation is sought
by the individual or
the individual's
authorized
representative with
respect to such
services;
(dd) is developed
through a person-
centered process that
is directed by the
individual or the
individual's authorized
representative, builds
upon the individual's
capacity to engage in
activities that promote
community life and that
respects the
individual's
preferences, choices,
and abilities, and
involves families,
friends, and
professionals as
desired or required by
the individual or the
individual's authorized
representative;
(ee) includes
appropriate risk
management techniques
that recognize the
roles and sharing of
responsibilities in
obtaining services in a
self-directed manner
and assure the
appropriateness of such
plan based upon the
resources and
capabilities of the
individual or the
individual's authorized
representative; and
(ff) may include an
individualized budget
which identifies the
dollar value of the
services and supports
under the control and
direction of the
individual or the
individual's authorized
representative.
(IV) Budget process.--With
respect to individualized
budgets described in subclause
(III)(ff), the State plan
amendment--
(aa) describes the
method for calculating
the dollar values in
such budgets based on
reliable costs and
service utilization;
(bb) defines a
process for making
adjustments in such
dollar values to
reflect changes in
individual assessments
and service plans; and
(cc) provides a
procedure to evaluate
expenditures under such
budgets.
(H) Quality assurance; conflict of interest
standards.--
(i) Quality assurance.--The State
ensures that the provision of home and
community-based services meets Federal
and State guidelines for quality
assurance.
(ii) Conflict of interest
standards.--The State establishes
standards for the conduct of the
independent evaluation and the
independent assessment to safeguard
against conflicts of interest.
(I) Redeterminations and appeals.--The State
allows for at least annual redeterminations of
eligibility, and appeals in accordance with the
frequency of, and manner in which,
redeterminations and appeals of eligibility are
made under the State plan.
(J) Presumptive eligibility for assessment.--
The State, at its option, elects to provide for
a period of presumptive eligibility (not to
exceed a period of 60 days) only for those
individuals that the State has reason to
believe may be eligible for home and community-
based services. Such presumptive eligibility
shall be limited to medical assistance for
carrying out the independent evaluation and
assessment under subparagraph (E) to determine
an individual's eligibility for such services
and if the individual is so eligible, the
specific home and community-based services that
the individual will receive.
(2) Definition of individual's representative.--In
this section, the term ``individual's representative''
means, with respect to an individual, a parent, a
family member, or a guardian of the individual, an
advocate for the individual, or any other individual
who is authorized to represent the individual.
(3) Nonapplication.--A State may elect in the State
plan amendment approved under this section to not
comply with the requirements of section 1902(a)(10)(B)
(relating to comparability) and section
1902(a)(10)(C)(i)(III) (relating to income and resource
rules applicable in the community), but only for
purposes of provided home and community-based services
in accordance with such amendment. Any such election
shall not be construed to apply to the provision of
services to an individual receiving medical assistance
in an institutionalized setting as a result of a
determination that the individual requires the level of
care provided in a hospital or a nursing facility or
intermediate care facility for the mentally retarded.
(4) No effect on other waiver authority.--Nothing in
this subsection shall be construed as affecting the
option of a State to offer home and community-based
services under a waiver under subsections (c) or (d) of
this section or under section 1115.
(5) Continuation of federal financial participation
for medical assistance provided to individuals as of
effective date of state plan amendment.--
Notwithstanding paragraph (1)(B), Federal financial
participation shall continue to be available for an
individual who is receiving medical assistance in an
institutionalized setting, or home and community-based
services provided under a waiver under this section or
section 1115 that is in effect as of the effective date
of the State plan amendment submitted under this
subsection, as a result of a determination that the
individual requires the level of care provided in a
hospital or a nursing facility or intermediate care
facility for the mentally retarded, without regard to
whether such individuals satisfy the more stringent
eligibility criteria established under that paragraph,
until such time as the individual is discharged from
the institution or waiver program or no longer requires
such level of care.
(6) State option to provide home and community-based
services to individuals eligible for services under a
waiver.--
(A) In general.--A State that provides home
and community-based services in accordance with
this subsection to individuals who satisfy the
needs-based criteria for the receipt of such
services established under paragraph (1)(A)
may, in addition to continuing to provide such
services to such individuals, elect to provide
home and community-based services in accordance
with the requirements of this paragraph to
individuals who are eligible for home and
community-based services under a waiver
approved for the State under subsection (c),
(d), or (e) or under section 1115 to provide
such services, but only for those individuals
whose income does not exceed 300 percent of the
supplemental security income benefit rate
established by section 1611(b)(1).
(B) Application of same requirements for
individuals satisfying needs-based criteria.--
Subject to subparagraph (C), a State shall
provide home and community-based services to
individuals under this paragraph in the same
manner and subject to the same requirements as
apply under the other paragraphs of this
subsection to the provision of home and
community-based services to individuals who
satisfy the needs-based criteria established
under paragraph (1)(A).
(C) Authority to offer different type,
amount, duration, or scope of home and
community-based services.--A State may offer
home and community-based services to
individuals under this paragraph that differ in
type, amount, duration, or scope from the home
and community-based services offered for
individuals who satisfy the needs-based
criteria established under paragraph (1)(A), so
long as such services are within the scope of
services described in paragraph (4)(B) of
subsection (c) for which the Secretary has the
authority to approve a waiver and do not
include room or board.
(7) State option to offer home and community-based
services to specific, targeted populations.--
(A) In general.--A State may elect in a State
plan amendment under this subsection to target
the provision of home and community-based
services under this subsection to specific
populations and to differ the type, amount,
duration, or scope of such services to such
specific populations.
(B) 5-year term.--
(i) In general.--An election by a
State under this paragraph shall be for
a period of 5 years.
(ii) Phase-in of services and
eligibility permitted during initial 5-
year period.--A State making an
election under this paragraph may,
during the first 5-year period for
which the election is made, phase-in
the enrollment of eligible individuals,
or the provision of services to such
individuals, or both, so long as all
eligible individuals in the State for
such services are enrolled, and all
such services are provided, before the
end of the initial 5-year period.
(C) Renewal.--An election by a State under
this paragraph may be renewed for additional 5-
year terms if the Secretary determines, prior
to beginning of each such renewal period, that
the State has--
(i) adhered to the requirements of
this subsection and paragraph in
providing services under such an
election; and
(ii) met the State's objectives with
respect to quality improvement and
beneficiary outcomes.
(j)(1) A State may provide, as ``medical assistance'',
payment for part or all of the cost of self-directed personal
assistance services (other than room and board) under the plan
which are provided pursuant to a written plan of care to
individuals with respect to whom there has been a determination
that, but for the provision of such services, the individuals
would require and receive personal care services under the
plan, or home and community-based services provided pursuant to
a waiver under subsection (c). Self-directed personal
assistance services may not be provided under this subsection
to individuals who reside in a home or property that is owned,
operated, or controlled by a provider of services, not related
by blood or marriage.
(2) The Secretary shall not grant approval for a State self-
directed personal assistance services program under this
section unless the State provides assurances satisfactory to
the Secretary of the following:
(A) Necessary safeguards have been taken to protect
the health and welfare of individuals provided services
under the program, and to assure financial
accountability for funds expended with respect to such
services.
(B) The State will provide, with respect to
individuals who--
(i) are entitled to medical assistance for
personal care services under the plan, or
receive home and community-based services under
a waiver granted under subsection (c);
(ii) may require self-directed personal
assistance services; and
(iii) may be eligible for self-directed
personal assistance services,
an evaluation of the need for personal care under the
plan, or personal services under a waiver granted under
subsection (c).
(C) Such individuals who are determined to be likely
to require personal care under the plan, or home and
community-based services under a waiver granted under
subsection (c) are informed of the feasible
alternatives, if available under the State's self-
directed personal assistance services program, at the
choice of such individuals, to the provision of
personal care services under the plan, or personal
assistance services under a waiver granted under
subsection (c).
(D) The State will provide for a support system that
ensures participants in the self-directed personal
assistance services program are appropriately assessed
and counseled prior to enrollment and are able to
manage their budgets. Additional counseling and
management support may be provided at the request of
the participant.
(E) The State will provide to the Secretary an annual
report on the number of individuals served and total
expenditures on their behalf in the aggregate. The
State shall also provide an evaluation of overall
impact on the health and welfare of participating
individuals compared to non-participants every three
years.
(3) A State may provide self-directed personal assistance
services under the State plan without regard to the
requirements of section 1902(a)(1) and may limit the population
eligible to receive these services and limit the number of
persons served without regard to section 1902(a)(10)(B).
(4)(A) For purposes of this subsection, the term ``self-
directed personal assistance services'' means personal care and
related services, or home and community-based services
otherwise available under the plan under this title or
subsection (c), that are provided to an eligible participant
under a self-directed personal assistance services program
under this section, under which individuals, within an approved
self-directed services plan and budget, purchase personal
assistance and related services, and permits participants to
hire, fire, supervise, and manage the individuals providing
such services.
(B) At the election of the State--
(i) a participant may choose to use any individual
capable of providing the assigned tasks including
legally liable relatives as paid providers of the
services; and
(ii) the individual may use the individual's budget
to acquire items that increase independence or
substitute (such as a microwave oven or an
accessibility ramp) for human assistance, to the extent
that expenditures would otherwise be made for the human
assistance.
(5) For purpose of this section, the term ``approved self-
directed services plan and budget'' means, with respect to a
participant, the establishment of a plan and budget for the
provision of self-directed personal assistance services,
consistent with the following requirements:
(A) Self-direction.--The participant (or in the case
of a participant who is a minor child, the
participant's parent or guardian, or in the case of an
incapacitated adult, another individual recognized by
State law to act on behalf of the participant)
exercises choice and control over the budget, planning,
and purchase of self-directed personal assistance
services, including the amount, duration, scope,
provider, and location of service provision.
(B) Assessment of needs.--There is an assessment of
the needs, strengths, and preferences of the
participants for such services.
(C) Service plan.--A plan for such services (and
supports for such services) for the participant has
been developed and approved by the State based on such
assessment through a person-centered process that--
(i) builds upon the participant's capacity to
engage in activities that promote community
life and that respects the participant's
preferences, choices, and abilities; and
(ii) involves families, friends, and
professionals in the planning or delivery of
services or supports as desired or required by
the participant.
(D) Service budget.--A budget for such services and
supports for the participant has been developed and
approved by the State based on such assessment and plan
and on a methodology that uses valid, reliable cost
data, is open to public inspection, and includes a
calculation of the expected cost of such services if
those services were not self-directed. The budget may
not restrict access to other medically necessary care
and services furnished under the plan and approved by
the State but not included in the budget.
(E) Application of quality assurance and risk
management.--There are appropriate quality assurance
and risk management techniques used in establishing and
implementing such plan and budget that recognize the
roles and responsibilities in obtaining services in a
self-directed manner and assure the appropriateness of
such plan and budget based upon the participant's
resources and capabilities.
(6) A State may employ a financial management entity to make
payments to providers, track costs, and make reports under the
program. Payment for the activities of the financial management
entity shall be at the administrative rate established in
section 1903(a).
(k) State Plan Option To Provide Home and Community-based
Attendant Services and Supports.--
(1) In general.--Subject to the succeeding provisions
of this subsection, beginning October 1, 2011, a State
may provide through a State plan amendment for the
provision of medical assistance for home and community-
based attendant services and supports for individuals
who are eligible for medical assistance under the State
plan whose income does not exceed 150 percent of the
poverty line (as defined in section 2110(c)(5)) or, if
greater, the income level applicable for an individual
who has been determined to require an institutional
level of care to be eligible for nursing facility
services under the State plan and with respect to whom
there has been a determination that, but for the
provision of such services, the individuals would
require the level of care provided in a hospital, a
nursing facility, an intermediate care facility for the
mentally retarded, or an institution for mental
diseases, the cost of which could be reimbursed under
the State plan, but only if the individual chooses to
receive such home and community-based attendant
services and supports, and only if the State meets the
following requirements:
(A) Availability.--The State shall make
available home and community-based attendant
services and supports to eligible individuals,
as needed, to assist in accomplishing
activities of daily living, instrumental
activities of daily living, and health-related
tasks through hands-on assistance, supervision,
or cueing--
(i) under a person-centered plan of
services and supports that is based on
an assessment of functional need and
that is agreed to in writing by the
individual or, as appropriate, the
individual's representative;
(ii) in a home or community setting,
which does not include a nursing
facility, institution for mental
diseases, or an intermediate care
facility for the mentally retarded;
(iii) under an agency-provider model
or other model (as defined in paragraph
(6)(C)); and
(iv) the furnishing of which--
(I) is selected, managed, and
dismissed by the individual,
or, as appropriate, with
assistance from the
individual's representative;
(II) is controlled, to the
maximum extent possible, by the
individual or where
appropriate, the individual's
representative, regardless of
who may act as the employer of
record; and
(III) provided by an
individual who is qualified to
provide such services,
including family members (as
defined by the Secretary).
(B) Included services and supports.--In
addition to assistance in accomplishing
activities of daily living, instrumental
activities of daily living, and health related
tasks, the home and community-based attendant
services and supports made available include--
(i) the acquisition, maintenance, and
enhancement of skills necessary for the
individual to accomplish activities of
daily living, instrumental activities
of daily living, and health related
tasks;
(ii) back-up systems or mechanisms
(such as the use of beepers or other
electronic devices) to ensure
continuity of services and supports;
and
(iii) voluntary training on how to
select, manage, and dismiss attendants.
(C) Excluded services and supports.--Subject
to subparagraph (D), the home and community-
based attendant services and supports made
available do not include--
(i) room and board costs for the
individual;
(ii) special education and related
services provided under the Individuals
with Disabilities Education Act and
vocational rehabilitation services
provided under the Rehabilitation Act
of 1973;
(iii) assistive technology devices
and assistive technology services other
than those under (1)(B)(ii);
(iv) medical supplies and equipment;
or
(v) home modifications.
(D) Permissible services and supports.--The
home and community-based attendant services and
supports may include--
(i) expenditures for transition costs
such as rent and utility deposits,
first month's rent and utilities,
bedding, basic kitchen supplies, and
other necessities required for an
individual to make the transition from
a nursing facility, institution for
mental diseases, or intermediate care
facility for the mentally retarded to a
community-based home setting where the
individual resides; and
(ii) expenditures relating to a need
identified in an individual's person-
centered plan of services that increase
independence or substitute for human
assistance, to the extent that
expenditures would otherwise be made
for the human assistance.
(2) Increased federal financial participation.--For
purposes of payments to a State under section
1903(a)(1), with respect to amounts expended by the
State to provide medical assistance under the State
plan for home and community-based attendant services
and supports to eligible individuals in accordance with
this subsection during a fiscal year quarter occurring
during the period described in paragraph (1), the
Federal medical assistance percentage applicable to the
State (as determined under section 1905(b)) shall be
increased by 6 percentage points.
(3) State requirements.--In order for a State plan
amendment to be approved under this subsection, the
State shall--
(A) develop and implement such amendment in
collaboration with a Development and
Implementation Council established by the State
that includes a majority of members with
disabilities, elderly individuals, and their
representatives and consults and collaborates
with such individuals;
(B) provide consumer controlled home and
community-based attendant services and supports
to individuals on a statewide basis, in a
manner that provides such services and supports
in the most integrated setting appropriate to
the individual's needs, and without regard to
the individual's age, type or nature of
disability, severity of disability, or the form
of home and community-based attendant services
and supports that the individual requires in
order to lead an independent life;
(C) with respect to expenditures during the
first full fiscal year in which the State plan
amendment is implemented, maintain or exceed
the level of State expenditures for medical
assistance that is provided under section
1905(a), section 1915, section 1115, or
otherwise to individuals with disabilities or
elderly individuals attributable to the
preceding fiscal year;
(D) establish and maintain a comprehensive,
continuous quality assurance system with
respect to community- based attendant services
and supports that--
(i) includes standards for agency-
based and other delivery models with
respect to training, appeals for
denials and reconsideration procedures
of an individual plan, and other
factors as determined by the Secretary;
(ii) incorporates feedback from
consumers and their representatives,
disability organizations, providers,
families of disabled or elderly
individuals, members of the community,
and others and maximizes consumer
independence and consumer control;
(iii) monitors the health and well-
being of each individual who receives
home and community-based attendant
services and supports, including a
process for the mandatory reporting,
investigation, and resolution of
allegations of neglect, abuse, or
exploitation in connection with the
provision of such services and
supports; and
(iv) provides information about the
provisions of the quality assurance
required under clauses (i) through
(iii) to each individual receiving such
services; and
(E) collect and report information, as
determined necessary by the Secretary, for the
purposes of approving the State plan amendment,
providing Federal oversight, and conducting an
evaluation under paragraph (5)(A), including
data regarding how the State provides home and
community-based attendant services and supports
and other home and community-based services,
the cost of such services and supports, and how
the State provides individuals with
disabilities who otherwise qualify for
institutional care under the State plan or
under a waiver the choice to instead receive
home and community-based services in lieu of
institutional care.
(4) Compliance with certain laws.--A State shall
ensure that, regardless of whether the State uses an
agency-provider model or other models to provide home
and community-based attendant services and supports
under a State plan amendment under this subsection,
such services and supports are provided in accordance
with the requirements of the Fair Labor Standards Act
of 1938 and applicable Federal and State laws
regarding--
(A) withholding and payment of Federal and
State income and payroll taxes;
(B) the provision of unemployment and workers
compensation insurance;
(C) maintenance of general liability
insurance; and
(D) occupational health and safety.
(5) Evaluation, data collection, and report to
congress.--
(A) Evaluation.--The Secretary shall conduct
an evaluation of the provision of home and
community-based attendant services and supports
under this subsection in order to determine the
effectiveness of the provision of such services
and supports in allowing the individuals
receiving such services and supports to lead an
independent life to the maximum extent
possible; the impact on the physical and
emotional health of the individuals who receive
such services; and an comparative analysis of
the costs of services provided under the State
plan amendment under this subsection and those
provided under institutional care in a nursing
facility, institution for mental diseases, or
an intermediate care facility for the mentally
retarded.
(B) Data collection.--The State shall provide
the Secretary with the following information
regarding the provision of home and community-
based attendant services and supports under
this subsection for each fiscal year for which
such services and supports are provided:
(i) The number of individuals who are
estimated to receive home and
community-based attendant services and
supports under this subsection during
the fiscal year.
(ii) The number of individuals that
received such services and supports
during the preceding fiscal year.
(iii) The specific number of
individuals served by type of
disability, age, gender, education
level, and employment status.
(iv) Whether the specific individuals
have been previously served under any
other home and community based services
program under the State plan or under a
waiver.
(C) Reports.--Not later than--
(i) December 31, 2013, the Secretary
shall submit to Congress and make
available to the public an interim
report on the findings of the
evaluation under subparagraph (A); and
(ii) December 31, 2015, the Secretary
shall submit to Congress and make
available to the public a final report
on the findings of the evaluation under
subparagraph (A).
(6) Definitions.--In this subsection:
(A) Activities of daily living.--The term
``activities of daily living'' includes tasks
such as eating, toileting, grooming, dressing,
bathing, and transferring.
(B) Consumer controlled.--The term ``consumer
controlled'' means a method of selecting and
providing services and supports that allow the
individual, or where appropriate, the
individual's representative, maximum control of
the home and community-based attendant services
and supports, regardless of who acts as the
employer of record.
(C) Delivery models.--
(i) Agency-provider model.--The term
``agency-provider model'' means, with
respect to the provision of home and
community-based attendant services and
supports for an individual, subject to
paragraph (4), a method of providing
consumer controlled services and
supports under which entities contract
for the provision of such services and
supports.
(ii) Other models.--The term ``other
models'' means, subject to paragraph
(4), methods, other than an agency-
provider model, for the provision of
consumer controlled services and
supports. Such models may include the
provision of vouchers, direct cash
payments, or use of a fiscal agent to
assist in obtaining services.
(D) Health-related tasks.--The term ``health-
related tasks'' means specific tasks related to
the needs of an individual, which can be
delegated or assigned by licensed health-care
professionals under State law to be performed
by an attendant.
(E) Individual's representative.--The term
``individual's representative'' means a parent,
family member, guardian, advocate, or other
authorized representative of an individual
(F) Instrumental activities of daily
living.--The term ``instrumental activities of
daily living'' includes (but is not limited to)
meal planning and preparation, managing
finances, shopping for food, clothing, and
other essential items, performing essential
household chores, communicating by phone or
other media, and traveling around and
participating in the community.
(l) State Plan Option to Provide Services for Certain
Individuals in Institutions for Mental Diseases.--
(1) In general.--With respect to calendar quarters
beginning during the period beginning January 1, 2019,
and ending December 31, 2023, a State may elect,
through a State plan amendment, to, notwithstanding
section 1905(a), provide medical assistance for
services furnished in institutions for mental diseases
and for other medically necessary services furnished to
eligible individuals with opioid use disorders, in
accordance with the requirements of this subsection.
(2) Payments.--
(A) In general.--Amounts expended under a
State plan amendment under paragraph (1) for
services described in such paragraph furnished,
with respect to a 12-month period, to an
eligible individual with an opioid use disorder
who is a patient in an institution for mental
diseases shall be treated as medical assistance
for which payment is made under section 1903(a)
but only to the extent that such services are
furnished for not more than a period of 30 days
(whether or not consecutive) during such 12-
month period.
(B) Clarification.--Payment made under this
paragraph for expenditures under a State plan
amendment under this subsection with respect to
services described in paragraph (1) furnished
to an eligible individual with an opioid use
disorder shall not affect payment that would
otherwise be made under section 1903(a) for
expenditures under the State plan (or waiver of
such plan) for medical assistance for such
individual.
(3) Information required in state plan amendment.--
(A) In general.--A State electing to provide
medical assistance pursuant to this subsection
shall include with the submission of the State
plan amendment under paragraph (1) to the
Secretary--
(i) a plan on how the State will
improve access to outpatient care
during the period of the State plan
amendment, including a description of--
(I) the process by which
eligible individuals with
opioid use disorders will make
the transition from receiving
inpatient services in an
institution for mental diseases
to appropriate outpatient care;
and
(II) the process the State
will undertake to ensure
individuals with opioid use
disorder are provided care in
the most integrated setting
appropriate to the needs of the
individuals; and
(ii) a description of how the State
plan amendment ensures an appropriate
clinical screening of eligible
individuals with an opioid use
disorder, including assessments to
determine level of care and length of
stay recommendations based upon the
multidimensional assessment criteria of
the American Society of Addiction
Medicine.
(B) Report.--Not later than the sooner of
December 31, 2024, or one year after the date
of the termination of a State plan amendment
under this subsection, the State shall submit
to the Secretary a report that includes at
least--
(i) the number of eligible
individuals with opioid use disorders
who received services pursuant to such
State plan amendment;
(ii) the length of the stay of each
such individual in an institution for
mental diseases; and
(iii) the type of outpatient
treatment, including medication-
assisted treatment, each such
individual received after being
discharged from such institution.
(4) Definitions.--In this subsection:
(A) Eligible individual with an opioid use
disorder.--The term ``eligible individual with
an opioid use disorder'' means an individual
who--
(i) with respect to a State, is
enrolled for medical assistance under
the State plan (or a waiver of such
plan);
(ii) is at least 21 years of age;
(iii) has not attained 65 years of
age; and
(iv) has been diagnosed with at least
one opioid use disorder.
(B) Institution for mental diseases.--The
term ``institution for mental diseases'' has
the meaning given such term in section 1905(i).
(C) Opioid prescription pain reliever.--The
term ``opioid prescription pain reliever''
includes hydrocodone products, oxycodone
products, tramadol products, codeine products,
morphine products, fentanyl products,
buprenorphine products, oxymorphone products,
meperidine products, hydromorphone products,
methadone, and any other prescription pain
reliever identified by the Assistant Secretary
for Mental Health and Substance Use.
(D) Opioid use disorder.--The term ``opioid
use disorder'' means a disorder that meets the
criteria of the Diagnostic and Statistical
Manual of Mental Disorders, 4th Edition (or a
successor edition), for heroin use disorder or
pain reliever use disorder (including with
respect to opioid prescription pain relievers).
(E) Other medically necessary services.--The
term ``other medically necessary services''
means, with respect to an eligible individual
with an opioid use disorder who is a patient in
an institution for mental diseases, items and
services that are provided to such individual
outside of such institution to the extent that
such items and services would be treated as
medical assistance for such individual if such
individual were not a patient in such
institution.
* * * * * * *
DISSENTING VIEWS
In recognition of states' traditional roles in treating
individuals with mental disorders, there is a long-standing
prohibition on using federal Medicaid matching funds to support
inpatient facilities with more than 16 beds that treat ``mental
diseases.''\1\ This provision, known as the ``IMD exclusion,''
applies equally to small facilities and to large state mental
hospitals. The IMD exclusion has been identified as a barrier
to building state capacity to treat individuals with Substance
Use Disorders. At the same time, the IMD exclusion often is
credited with helping to accomplish a shift away from
institutional care and segregation of people with mental
illness and Substance Use Disorder (SUD). For the past 54 years
the United States has been engaged in an effort to effectively
bring people with mental illness and SUD into the mainstream of
American society and its medical care arrangements.
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\1\The regulatory definition of an institution for mental diseases
is found at 42 CFR 435.1010.
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However, when integrated into a full continuum of care, IMD
treatment for SUD can provide an important option for treatment
for some individuals. Importantly, the Centers for Medicare and
Medicaid Services (CMS) have exercised significant
administrative flexibility already with respects to the
statutory IMD exclusion, prioritizing IMDs for SUD as one part
of the continuum of care. States can receive approval to waive
the IMD exclusion through Section 1115 demonstrations (also
known as ``waivers'') when pursuing ``broad and deep system
transformations'' in the area of SUD. More than 20 state
Medicaid programs have approved SUD waivers or pending SUD
waivers before CMS that allow for IMD reimbursement. More
broadly, states are providing IMD services for both mental
health and SUD needs through capitated payments to managed care
organizations\2\, and lump-sum payments from Disproportionate
Share Hospital (DSH) funding.\3\
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\2\Centers for Medicare and Medicaid Services, Medicaid and
Children's Health Insurance Program (CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care, and Revisions Related to Third
Party Liability, Final Rule (Mar. 6, 2016) (https://
www.federalregister.gov/documents/2016/05/06/2016-09581/medicaid-and-
childrens-health-insurance-program-chip-programs-medicaid-managed-care-
chip-delivered).
\3\Kelsey C. Priest, et al., Medicaid Coverage For Residential
Substance Use Disorder Treatment: Addressing The Institution For Mental
Disease Exclusion Policy, Health Affairs Blog (Aug. 31, 2017) (https://
www.healthaffairs.org/do/10.1377/hblog20170831.061745/full/).
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Unfortunately, the legislation reported by the Committee is
less flexible than the administrative options currently
available to states; allowing for a five-year state option that
would lift the IMD exclusion for Opioid Use Disorder (OUD) only
for a 30-day period in a calendar year.
Studies have demonstrated a high rate of co-occurring
substance-related disorders. Studies have demonstrated up to 80
percent of those being treated for OUD had another substance
use disorder.4,5 During the initial assessment for
substance abuse therapy, any factors that may influence a
patient's use of opioids, such as dependence or abuse of other
substances, must be taken into consideration. Then, management
of withdrawal symptoms from and treatment for all substances
should be addressed as part of the treatment plan.\6\
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\4\American Society of Addiction Medicine. National Practice
Guideline For the Use of Medications in the Treatment of Addiction
Involving Opioid Use. (Jun 1, 2015) (https://www.asam.org/docs/default-
source/practice-support/guidelines-and-consensus-docs/asam-national-
practice-guideline-supplement.pdf)
\5\Wu, Li-Tzy., Zhu, He, Swartz, Marvin S. Treatment Utilization
among persons with opioid use disorder in the United States. Drug and
Alcohol Dependence. (Oct 19, 2016).
\6\American Psychiatric Assocation. Practice Guideline for the
Treatment of Patients with Substance Use Disorders, 2nd Edition. (2010)
(https://psychiatryonline.org/pb/assets/raw/sitewide/practice
guidelines/guidelines/substanceuse.pdf)
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The correlation between OUD and abuse of other depressants
is high.\7\ In those with OUD, 65-75 percent also have a
benzodiazepine abuse disorder and 12-25 percent have alcohol
abuse.8,9,10 Treatment for any substance use
disorder (SUD) includes a comprehensive approach that addresses
the entirety of a patient's medical and psychosocial
conditions. Those with OUD frequently suffer from other SUDs,
such as alcohol, cocaine, methamphetamine, or benzodiazepine
abuse.
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\7\See note 3.
\8\See note 4.
\9\Jones, Jermaine D., Mogali, Shanthi, and Corner, Sandra D.
Polydrug abuse: A review of opioid and benzodiazepine combination use.
Drug and Alcohol Dependence. (Aug 2, 2012)
\10\McCabe, S.E., et al. Simultaneous and concurrent polydrug use
of alcohol and prescription drugs: Prevalence, correlates, and
consequences. Journal of Studies on Alcohol (2006).
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Given the high overlap of OUD with other forms of substance
abuse, it is vital that treatment options exist not only for
OUD, but for all substance use disorders. For those with any
SUD, a no wrong door approach allows patients desiring to be
treated for any SUD to receive comprehensive consideration of
all medical and psychiatric conditions, including other
substance use disorders.
Therefore, repeal of the IMD Exclusion for OUD exclusively,
as this legislation does, creates additional barriers and may
further limit treatment options for patients that require
treatment for other substances. Additionally, fewer resources
and less access to treatment for individuals that initially
seek treatment for substances other than OUD would mean missed
opportunities to engage patients in SUD treatment.
Conversely, creating an option whereby states would put in
place two different benefit packages for SUD based on the
substance an individual is addicted to could create a perverse
incentive towards opioids or reported opioid abuse in the hopes
of gaining access to treatment. At the very least, such an
option would create the practical effect of a two-tiered system
for substance use disorder in states that chose to take the
option created by the legislation, leaving some beneficiaries
worse off than others and without access to the same level of
treatment.
Given these concerns, Democratic members of the Committee
do not support a repeal of the IMD exclusion in this form.
Frank Pallone, Jr.
Ranking Member.
