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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.
---------------------------------------------------------------------------
    \1\The regulatory definition of an institution for mental diseases 
is found at 42 CFR 435.1010.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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/).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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)
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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.