[House Report 115-726]
[From the U.S. Government Publishing Office]


115th Congress }                                          { REPORT
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 115-726

======================================================================
 
                MEDICAID PHARMACEUTICAL HOME ACT OF 2018

                                _______
                                

 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

                            ADDITIONAL VIEWS

                        [To accompany H.R. 5808]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5808) to amend title XIX of the Social Security 
Act to require States to operate drug management programs for 
at-risk beneficiaries, and for other purposes, having 
considered the same, report favorably thereon without amendment 
and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Committee Action.................................................     5
Committee Votes..................................................     5
Oversight Findings and Recommendations...........................     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................    27
Statement of General Performance Goals and Objectives............    27
Duplication of Federal Programs..................................    27
Committee Cost Estimate..........................................    27
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    28
Disclosure of Directed Rule Makings..............................    28
Advisory Committee Statement.....................................    28
Applicability to Legislative Branch..............................    28
Section-by-Section Analysis of the Legislation...................    28
Changes in Existing Law Made by the Bill, as Reported............    28
Additional Dissenting Views......................................    36

                          Purpose and Summary

    H.R. 5808 was introduced on May 15, 2018, by Rep. Gus 
Bilirakis (R-FL). The bill requires states to operate qualified 
drug management programs for at-risk beneficiaries beginning 
January 1, 2020, describes the elements of a qualified drug 
management program including enrollment, notification, and re-
enrollment, and allows states that operate a drug management 
program under a fee-for-service financial arrangement upon 
enactment to be considered a qualified program.

                  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/
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    Medicaid is the largest source of federal funding for 
behavioral health services--mental health and substance use 
disorder services--with nearly $71 billion in projected 2017 
spending.\6\ As the Medicaid and CHIP Payment and Access 
Commission (MACPAC) stated in 2017, ``the opioid epidemic, 
which has reached most communities across the U.S., 
disproportionately affects Medicaid beneficiaries.''\7\ Of the 
two million non-elderly Americans with opioid addiction, 
Medicaid provides health coverage for an estimated 38 percent 
of this population, which is the largest percentage of any 
insurer type.\8\ Medicaid provides care to 4 in 10 adults with 
opioid use disorder and compared to other insurance types, 
provides a significantly higher percentage of inpatient and 
outpatient substance use disorder treatment.\9\
---------------------------------------------------------------------------
    \6\Government Accountability Office, ``Medicaid: States Fund 
Services for Adults in Institutions for Mental Disease Using a Variety 
of Strategies,'' GAO-17-652, August 2017. Available at https://
www.gao.gov/assets/690/686456.pdf
    \7\Medicaid and CHIP Payment and Access Commission, ``Medicaid and 
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on 
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf
    \8\Kaiser Family Foundation. ``Medicaid's Role in Addressing the 
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/
    \9\Kaiser Family Foundation. ``Medicaid's Role in Addressing the 
Opioid Epidemic.'' Available at https://www.kff.org/infographic/
medicaids-role-in-addressing-opioid-epidemic/
---------------------------------------------------------------------------
    MACPAC found that ``Medicaid beneficiaries are prescribed 
pain relievers at higher rates than those with other sources of 
insurance. They also have a higher risk of overdose and other 
negative outcomes, from both prescription opioids and illegal 
opioids such as heroin and illicitly manufactured 
fentanyl.''\10\ Not only are the number of Medicaid 
beneficiaries with opioid misuse disproportionately high, so 
too are the number of overdoses. Studies from North Carolina 
and Washington indicate high rates of opioid-related deaths for 
the Medicaid population (33 percent and 45 percent, 
respectively).
---------------------------------------------------------------------------
    \10\Medicaid and CHIP Payment and Access Commission, ``Medicaid and 
the Opioid Epidemic,'' Chapter 2 in June 2017 Report to Congress on 
Medicaid and CHIP. Available at: https://www.macpac.gov/wp-content/
uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf
---------------------------------------------------------------------------
    For treatment, Medicaid has several pharmacy and medical 
benefits for treating opioid use disorder that vary by state. A 
primary pharmaceutical treatment offered to patients with 
opioid abuse and/or substance use disorder is medication-
assisted treatment (MAT). The Substance Abuse and Mental Health 
Services Administration (SAMHSA) describes MAT as ``the use of 
FDA-approved medications, in combination with counseling and 
behavioral therapies, to provide a ``whole-patient'' approach 
to the treatment of substance use disorders.''\11\
---------------------------------------------------------------------------
    \11\See SAMHSA website. Available at: https://www.samhsa.gov/
medication-assisted-treatment
---------------------------------------------------------------------------
    Non-pharmaceutical treatment of opioid use disorder in 
Medicaid occurs in inpatient, outpatient, residential, and 
community-based settings. MACPAC's 2017 analysis found that 
``Medicaid is responding to the opioid crisis by covering 
treatment, innovating in the delivery of care, and working with 
other state agencies to reduce misuse of prescription 
opioids.''\12\ 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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    However, as MACPAC noted, ``there are gaps in the continuum 
of care, and states vary in the extent to which they cover 
needed treatment.''\13\ One of the barriers to appropriate 
treatment consistently identified by Medicaid directors and 
health policy experts is a statutory prohibition on federal 
Medicaid matching funds for paying for care for certain 
Medicaid beneficiaries in Institutions for Mental Diseases 
(IMD). As MACPAC has explained, ``the Medicaid IMD exclusion 
acts a barrier for individuals with an opioid use disorder to 
receive residential treatment, which, depending on an 
individual's treatment plan, may be the most appropriate 
setting for care.''\14\ 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.
---------------------------------------------------------------------------
    \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\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
---------------------------------------------------------------------------
    Federal law requires state Medicaid programs to permit 
beneficiaries to receive care from any institution, agency, 
community pharmacy, or person, qualified to perform the 
required services. States are permitted to waive the freedom-
of-choice of provider requirements under certain conditions, 
such as to require beneficiaries to enroll in a managed care 
plan.
    In addition to waivers of freedom-of-choice of provider for 
managed care, if a state Medicaid program determines that 
beneficiaries have over-utilized services, as determined by the 
state, the Medicaid program has the option to restrict 
beneficiaries, for a reasonable period of time, to receiving 
Medicaid services only from designated providers as long as the 
following conditions are met:
     The state gives beneficiaries notice and 
opportunity for a hearing (in accordance with procedures 
established by the state) before restricting provider access.
     The state ensures that beneficiaries have 
reasonable access (taking into account geographic location and 
reasonable travel time) to Medicaid services of adequate 
quality.
     The freedom-of-choice of provider restrictions do 
not apply to emergency services.
    Programs to restrict patient access to certain providers 
are known as lock-in programs or Patient Review and Restrictive 
(PRR) programs. PRR programs often are used to prevent 
excessive or fraudulent drug utilization. In 2016, most state 
Medicaid programs reported that they had some form of 
controlled substance PRR. States have different PPR/lock-in 
policies, such as for over utilization of more than one 
controlled substance, seeking drugs from more than one provider 
or more than one pharmacy, or for multiple emergency room 
visits. In addition, some states lock-in beneficiaries to only 
one prescriber or only one pharmacy or both and have differing 
lock-in time periods.
    PRR programs have resulted in cost savings and decreased 
drug utilization. For example, North Carolina's lock-in 
decreased the mean number of per member per month opioid and 
benzodiazepine prescription fills by 17 percent.\15\ Washington 
found the average number of controlled substance prescriptions 
went from 3.07 to 1.63.\16\ Finally, the 2016 CMS Drug 
Utilization Report showed that on average states saved about 
$1.5 million on drug avoidance/savings.\17\
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    \15\Roberts AW, Farley JF, Holmes GM, et al. Controlled Substance 
Lock-In Programs: Examining an Unintended Consequence of a Prescription 
Drug Abuse Policy. Health Affairs. Oct 2016, Vol 35(10).
    \16\http://www.wsha.org/wp-content/uploads/ercareplans_PRC-webcast-
May-1-2012-Final.pptx
    \17\Centers for Medicare and Medicaid Services, Center for Medicaid 
& CHIP Services. ``Medicaid Drug Utilization Review State Comparison/ 
Summary Report FFY 2016 Annual Report.'' October 2017. Available at: 
https://www.medicaid.gov/medicaid-chip-program-information/by-topics/
prescription-drugs/downloads/2016-dur-summary-report.pdf
---------------------------------------------------------------------------

                            Committee Action

    On April 11, 2018, the Subcommittee on Health held a 
hearing on the discussion draft entitled ``Medicaid 
Pharmaceutical Home Act.'' 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 18 yeas 
and 14 nays. On May 17, 2018, the full Committee on Energy and 
Commerce met in open markup session and ordered H.R. 5808, 
without amendment, 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. 5808 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. 5808 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, the following is 
the cost estimate provided by the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed document with cost estimates for the 
opioid-related legislation ordered to be reported on May 9 and 
May 17, 2018.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Tom Bradley 
and Chad Chirico.
            Sincerely,
                                             Mark P. Hadley
                                        (For Keith Hall, Director).
    Enclosure.

Opioid Legislation

    Summary: On May 9 and May 17, 2018, the House Committee on 
Energy and Commerce ordered 59 bills to be reported related to 
the nation's response to the opioid epidemic. Generally, the 
bills would:
           Provide grants to facilities and providers 
        that treat people with substance use disorders,
           Direct various agencies within the 
        Department of Health and Human Services (HHS) to 
        explore nonopioid approaches to treating pain and to 
        educate providers about those alternatives,
           Modify requirements under Medicaid and 
        Medicare for prescribing controlled substances,
           Expand Medicaid coverage for substance abuse 
        treatment, and
           Direct the Food and Drug Administration 
        (FDA) to modify its oversight of opioid drugs and other 
        medications that are used to manage pain.
    Because of the large number of related bills ordered 
reported by the Committee, CBO is publishing a single 
comprehensive document that includes estimates for each piece 
of legislation.
    CBO estimates that enacting 20 of the bills would affect 
direct spending, and 2 of the bills would affect revenues; 
therefore, pay-as-you-go procedures apply for those bills.
    CBO estimates that enacting H.R. 4998, the Health Insurance 
for Former Foster Youth Act, would increase net direct spending 
by more than $2.5 billion and on-budget deficits by more than 
$5 billion in at least one of the four consecutive 10-year 
periods beginning in 2029. None of the remaining 58 bills 
included in this estimate would increase net direct spending by 
more than $2.5 billion or on-budget deficits by more than $5 
billion in any of the four consecutive 10-year periods 
beginning in 2029.
    One of the bills reviewed for this document, H.R. 5795, 
would impose both intergovernmental and private-sector mandates 
as defined in the Unfunded Mandates Reform Act (UMRA). CBO 
estimates that the costs of those mandates on public and 
private entities would fall below the thresholds in UMRA ($80 
million and $160 million, respectively, in 2018, adjusted 
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R. 
5554, H.R. 5687, and H.R. 5811, would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of the bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would not exceed the UMRA threshold for private 
entities. Because CBO is uncertain how federal agencies would 
implement new authority granted in the other two bills, H.R. 
5228 and H.R. 5687, CBO cannot determine whether the costs of 
those mandates would exceed the UMRA threshold.
    Estimated cost to the Federal Government: The estimates in 
this document do not include the effects of interactions among 
the bills. If all 59 bills were combined and enacted as one 
piece of legislation, the budgetary effects would be different 
from the sum of the estimates in this document, although CBO 
expects that any such differences would be small. The costs of 
this legislation fall within budget functions 550 (health), 570 
(Medicare), 750 (administration of justice), and 800 (general 
government).
    Basis of estimate: For this estimate, CBO assumes that all 
of the legislation will be enacted late in 2018 and that 
authorized and estimated amounts will be appropriated each 
year. Outlays for discretionary programs are estimated based on 
historical spending patterns for similar programs.

Uncertainty

    CBO aims to produce estimates that generally reflect the 
middle of a range of the most likely budgetary outcomes that 
would result if the legislation was enacted. Because data on 
the utilization of mental health and substance abuse treatment 
under Medicaid and Medicare is scarce, CBO cannot precisely 
predict how patients or providers would respond to some policy 
changes or what budgetary effects would result. In addition, 
several of the bills would give the Department of Health and 
Human Services (HHS) considerable latitude in designing and 
implementing policies. Budgetary effects could differ from 
those provided in CBO's analyses depending on those decisions.

Direct Spending and Revenues

    Table 1 lists the 22 bills of the 59 ordered to be reported 
that would affect direct spending or revenues.

                                             TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         By fiscal year, in millions of dollars--
                                ------------------------------------------------------------------------------------------------------------------------
                                   2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     2028   2019-2023  2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      INCREASES OR DECREASES (-) IN DIRECT SPENDING
 
Legislation Primarily Affecting
 Medicaid:
    H.R. 1925, At-Risk Youth           0        *        5        5        5       10       10       10       10       10       10        25          75
     Medicaid Protection Act of
     2017......................
    H.R. 4998, Health Insurance        0        0        0        0        0        *       10       21       33       46       61         *         171
     for Former Foster Youth
     Act.......................
    H.R. 5477, Rural                   0       13       35       58       68       83       27        9        3        3        3       256         301
     Development of Opioid
     Capacity Services Act.....
    H.R. 5583, a bill to amend         0        *        *        *        *        *        *        *        *        *        *         *           *
     title XI of the Social
     Security Act to require
     States to annually report
     on certain adult health
     quality measures, and for
     other purposes............
    H.R. 5797, IMD CARE Act....        0       38      158      251      265      279        0        0        0        0        0       991         991
    H.R. 5799, Medicaid DRUG           0        *        *        1        1        1        1        1        1        1        1         2           5
     Improvement Acta..........
    H.R. 5801 Medicaid                 0        *        *        *        *        *        *        *        *        *        *         *           *
     Providers Are Required To
     Note Experiences in Record
     Systems to Help In-Need
     Patients (PARTNERSHIP)
     Acta......................
    H.R. 5808, Medicaid                0        *       -1       -1       -1       -1       -2       -2       -2       -2       -2        -4         -13
     Pharmaceutical Home Act of
     2018a.....................
    H.R. 5810, Medicaid Health         0       94       58       62       56       52       48       43       38       32       25       323         509
     HOME Act..................
Legislation Primarily Affecting
 Medicare:
    H.R. 3528, Every                   0        0        0      -24      -35      -33      -30      -33      -32      -31      -32       -92        -250
     Prescription Conveyed
     Securely Act..............
    H.R. 4841, Standardizing           0        0        0        *        *        *        *        *        *        *        *         *           *
     Electronic Prior
     Authorization for Safe
     Prescribing Act of 2018...
    H.R. 5603, Access to               0        2        *        *        *        1        1        1        2        2        2         3          11
     Telehealth Services for
     Opioid Use Disorders Act..
    H.R. 5605, Advancing High          0        0        0       15       26       24       23       23       10        1        *        65         122
     Quality Treatment for
     Opioid Use Disorders in
     Medicare Act..............
    H.R. 5675, a bill to amend         0        0        0       -6       -7       -7       -7       -8       -9       -9      -11       -20         -64
     title XVIII of the Social
     Security Act to require
     prescription drug plan
     sponsors under the
     Medicare program to
     establish drug management
     programs for at-risk
     beneficiaries.............
    H.R. 5684, Protecting              0        0        0        *        *        *        *        *        *        *        *         *           *
     Seniors From Opioid Abuse
     Act.......................
    H.R. 5796, Responsible             0       10       25       50       10        5        0        0        0        0        0       100         100
     Education Achieves Care
     and Healthy Outcomes for
     Users' Treatment Act of
     2018......................
    H.R. 5798, Opioid Screening        0        0        *        1        1        1        1        1        1        1        1         2           5
     and Chronic Pain
     Management Alternatives
     for Seniors Act...........
    H.R. 5804, Post-Surgical           0        0       25       30       25       20       10        5        0        0        0       100         115
     Injections as an Opioid
     Alternative Acta..........
    H.R. 5809, Postoperative           0        0        0        0       10       15       20       25       30       35       45        25         180
     Opioid Prevention Act of
     2018......................
Legislation Primarily Affecting
 the Food and Drug
 Administration:
    H.R. 5333, Over-the-Counter        0        0        *        *        *        *        *        *        *        *        *         *           *
     Monograph Safety,
     Innovation, and Reform Act
     of 2018a..................
 
                                                         INCREASES OR DECREASES (-) IN REVENUESb
 
    H.R. 5752, Stop Illicit            0        *        *        *        *        *        *        *        *        *        *         *          *
     Drug Importation Act of
     2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.

    Legislation Primarily Affecting Medicaid. The following 
nine bills would affect direct spending for the Medicaid 
program.
    H.R. 1925, the At-Risk Youth Medicaid Protection Act of 
2017, would require states to suspend, rather than terminate, 
Medicaid eligibility for juvenile enrollees (generally under 21 
years of age) who become inmates of public correctional 
institutions. States also would have to redetermine those 
enrollees' Medicaid eligibility before their release and 
restore their coverage upon release if they qualify for the 
program. States would be required to process Medicaid 
applications submitted by or on behalf of juveniles in public 
correctional institutions who were not enrolled in Medicaid 
before becoming inmates and ensure that Medicaid coverage is 
provided when they are released if they are found to be 
eligible. On the basis of an analysis of juvenile incarceration 
trends and of the per enrollee spending for Medicaid foster 
care children, who have a similar health profile to 
incarcerated juveniles, CBO estimates that implementing the 
bill would cost $75 million over the 2019-2028 period.
    H.R. 4998, the Health Insurance for Former Foster Youth 
Act, would require states to provide Medicaid coverage to 
adults up to age 25 who had aged out of foster care in any 
state. Under current law, such coverage is mandatory only if 
the former foster care youth has aged out in the state in which 
the individual applies for coverage. The policy also would 
apply to former foster children who had been in foster care 
upon turning 14 years of age but subsequently left foster care 
to enter into a legal guardianship with a kinship caregiver. 
The provisions would take effect respect for foster youth who 
turn 18 on or after January 1, 2023. On the basis of spending 
for Medicaid foster care children and data from the Census 
Bureau regarding annual migration rates between states, CBO 
estimates that implementing the bill would cost $171 million 
over the 2019-2028 period.
    H.R. 5477, the Rural Development of Opioid Capacity 
Services Act, would direct the Secretary of HHS to conduct a 
five-year demonstration to increase the number and ability of 
providers participating in Medicaid to provide treatment for 
substance use disorders. On the basis of an analysis of federal 
and state spending for treatment of substance use disorders and 
the prevalence of such disorders, CBO estimates that enacting 
the bill would increase direct spending by $301 million over 
the 2019-2028 period.
    H.R. 5583, a bill to amend title XI of the Social Security 
Act to require States to annually report on certain adult 
health quality measures, and for other purposes, would require 
states to include behavioral health indicators in their annual 
reports on the quality of care under Medicaid. Although the 
bill would add a requirement for states, CBO estimates that its 
enactment would not have a significant budgetary effect because 
most states have systems in place for reporting such measures 
to the federal government.
    H.R. 5797, the IMD CARE Act, would expand Medicaid coverage 
for people with opioid use disorder who are in institutions for 
mental disease (IMDs) for up to 30 days per year. Under a 
current-law policy known as the IMD exclusion, the federal 
government generally does not make matching payments to state 
Medicaid programs for most services provided by IMDs to adults 
between the ages of 21 and 64. Recent administrative changes 
have made federal financing for IMDs available in limited 
circumstances, but the statutory prohibition remains in place. 
CBO analyzed several data sets, primarily those collected by 
the Substance Abuse and Mental Health Services Administration 
(SAMHSA), to estimate current federal spending under Medicaid 
for IMD services and to estimate spending under H.R. 5797. 
Using that analysis, CBO estimates that enacting H.R. 5797 
would increase direct spending by $991 million over the 2019-
2028 period.
    H.R. 5799, the Medicaid DRUG Improvement Act, would require 
state Medicaid programs to implement additional reviews of 
opioid prescriptions, monitor concurrent prescribing of opioids 
and certain other drugs, and monitor use of antipsychotic drugs 
by children. CBO estimates that the bill would increase direct 
spending by $5 million over the 2019-2028 period to cover the 
administrative costs of complying with those requirements. On 
the basis of stakeholder feedback, CBO expects that the bill 
would not have a significant effect on Medicaid spending for 
prescription drugs because many of the bill's requirements 
would duplicate current efforts to curb opioid and 
antipsychotic drug use. (If enacted, H.R. 5799 also would 
affect spending subject to appropriation; CBO has not completed 
an estimate of that amount.)
    H.R. 5801, the Medicaid Providers Are Required To Note 
Experiences in Record Systems to Help In-Need Patients 
(PARTNERSHIP) Act, would require providers who are permitted to 
prescribe controlled substances and who participate in Medicaid 
to query prescription drug monitoring programs (PDMPs) before 
prescribing controlled substances to Medicaid patients. PDMPs 
are statewide electronic databases that collect data on 
controlled substances dispensed in the state. The bill also 
would require PDMPs to comply with certain data and system 
criteria, and it would provide additional federal matching 
funds to certain states to help cover administrative costs. On 
the basis of a literature review and stakeholder feedback, CBO 
estimates that the net budgetary effect of enacting H.R. 5801 
would be insignificant. Costs for states to come into 
compliance with the systems and administrative requirements 
would be roughly offset by savings from small reductions in the 
number of controlled substances paid for by Medicaid under the 
proposal. (If enacted, H.R. 5801 also would affect spending 
subject to appropriation; CBO has not completed an estimate of 
that amount.)
    H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018, 
would require state Medicaid programs to operate pharmacy 
programs that would identify people at high risk of abusing 
controlled substances and require those patients to use a 
limited number of providers and pharmacies. Although nearly all 
state Medicaid programs currently meet such a requirement, a 
small number of high-risk Medicaid beneficiaries are not now 
monitored. Based on an analysis of information about similar 
state and federal programs, CBO estimates that net Medicaid 
spending under the bill would decrease by $13 million over the 
2019-2028 period. That amount represents a small increase in 
administrative costs and a small reduction in the number of 
controlled substances paid for by Medicaid under the proposal. 
(If enacted, H.R. 5808 also would affect spending subject to 
appropriation; CBO has not completed an estimate of that 
amount.)
    H.R. 5810, the Medicaid Health HOME Act, would allow states 
to receive six months of enhanced federal Medicaid funding for 
programs that coordinate care for people with substance use 
disorders. Based on enrollment and spending data from states 
that currently participate in Medicaid's Health Homes program, 
CBO estimates that the expansion would cost approximately $469 
million over the 2019-2028 period. The bill also would require 
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a 
waiver from that requirement. (Medication-assisted treatment 
combines behavioral therapy and pharmaceutical treatment for 
substance use disorders.) Under current law, states already 
cover most FDA-approved drugs used in such programs in some 
capacity, although a few exclude methadone dispensed by opioid 
treatment programs. CBO estimates that a small share of those 
states would begin to cover methadone if this bill was enacted 
at a federal cost of about $39 million over the 2019-2028 
period. In sum, CBO estimates that the enacting H.R. 5810 would 
increase direct spending by $509 million over the 2019-2028 
period.
    Legislation Primarily Affecting Medicare. The following ten 
bills would affect direct spending for the Medicare program.
    H.R. 3528, the Every Prescription Conveyed Securely Act, 
would require prescriptions for controlled substances covered 
under Medicare Part D to be transmitted electronically, 
starting on January 1, 2021. Based on CBO's analysis of 
prescription drug spending, spending for controlled substances 
is a small share of total drug spending. CBO also assumes a 
small share of those prescriptions would not be filled because 
they are not converted to an electronic format. Therefore, CBO 
expects that enacting H.R. 3528 would reduce the number of 
prescriptions filled and estimates that Medicare spending would 
be reduced by $250 million over the 2019-2028 period.
    H.R. 4841, the Standardizing Electronic Prior Authorization 
for Safe Prescribing Act of 2018, would require health care 
professionals to submit prior authorization requests 
electronically, starting on January 1, 2021, for drugs covered 
under Medicare Part D. Taking into account that many 
prescribers already use electronic methods to submit such 
requests, CBO estimates that enacting H.R. 4841 would not 
significantly affect direct spending for Part D.
    H.R. 5603, the Access to Telehealth Services for Opioid Use 
Disorders Act, would permit the Secretary of HHS to lift 
current geographic and other restrictions on coverage of 
telehealth services under Medicare for treatment of substance 
use disorders or co-occurring mental health disorders. Under 
the bill, the Secretary of HHS would be directed to encourage 
other payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on current use of Medicare 
telehealth services for treatment of substance use disorders, 
CBO estimates that expanding that coverage would increase 
direct spending by $11 million over the 2019-2028 period.
    H.R. 5605, the Advancing High Quality Treatment for Opioid 
Use Disorders in Medicare Act, would establish a five-year 
demonstration program to increase access to treatment for 
opioid use disorder. The demonstration would provide incentive 
payments and funding for care management services based on 
criteria such as patient engagement, use of evidence-based 
treatments, and treatment length and intensity. Under the bill, 
the Secretary of HHS would be directed to encourage other 
payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on historical utilization of 
opioid use disorder treatments and projected spending on 
incentive payments and care management fees, CBO estimates that 
increased use of treatment services and the demonstration's 
incentive payments would increase direct spending by $122 
million over the 2019-2028 period.
    H.R. 5675, a bill to amend title XVIII of the Social 
Security Act to require prescription drug plan sponsors under 
the Medicare program to establish drug management programs for 
at-risk beneficiaries, would require Part D prescription drug 
plans to provide drug management programs for Medicare 
beneficiaries who are at risk for prescription drug abuse. 
(Under current law, Part D plans are permitted but not required 
to establish such programs as of 2019.) Based on an analysis of 
the number of plans currently providing those programs, CBO 
estimates that enacting H.R. 5675 would lower federal spending 
by $64 million over the 2019-2028 period by reducing the number 
of prescriptions filled and Medicare's payments for controlled 
substances.
    H.R. 5684, the Protecting Seniors From 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 the Public Health Service Act 
by broadening the focus of surveillance and education programs 
from preventing and treating hepatitis C virus to preventing 
and treating infections associated with injection drug use. It 
would authorize $40 million per year over 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 Reentty 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 
period, primarily because of that lag. The bill also would 
require the Government Accountability Office to study exclusive 
market protections for certain qualifying OTC drugs authorized 
by the bill--a provision that CBO estimates would cost less 
than $500,000. (If enacted, H.R. 5333 also would affect 
mandatory spending; see Table 1.)
    H.R. 5473, the Better Pain Management Through Better Data 
Act of 2018, would require that the FDA conduct a public 
meeting and issue guidance to industry addressing data 
collection and labeling for medical products that reduce pain 
while enabling the reduction, replacement, or avoidance of oral 
opioids. Using information from the agency, CBO estimates that 
implementing H.R. 5473 would cost about $1 million over the 
2019-2023 period.
    H.R. 5483, the Special Registration for Telemedicine 
Clarification Act of 2018, would direct DOJ, within one year of 
the bill's enactment, to issue regulations concerning the 
practice of telemedicine (for remote diagnosis and treatment of 
patients). Using information from DOJ, CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would authorize the FDA to collect and 
spend fees to cover the cost of expedited approval for the 
development and marketing of certain drugs for use in animals. 
The legislation would extend through fiscal year 2023, and make 
several changes to, the FDA's existing approval processes and 
fee programs for brand-name and generic veterinary drugs, which 
expire at the end of fiscal year 2018. CBO estimates that 
implementing H.R. 5554 would reduce net discretionary outlays 
by $8 million over the 2019-2023 period, primarily because the 
spending of fees lags somewhat behind their collection.
    Fees authorized under the bill would supplement funds 
appropriated to cover the FDA's cost of reviewing certain 
applications and investigational submissions for brand-name and 
generic drugs for use in animals. Those fees could be collected 
and made available for obligation only to the extent and in the 
amounts provided in advance in appropriation acts. Under H.R. 
5554, CBO estimates, the FDA would assess about $257 million in 
fees over the 2019-2023 period. Because the FDA could spend 
those funds, CBO estimates that budget authority for 
collections and spending would offset each other exactly in 
each year. CBO estimates that the delay between collecting and 
spending fees under the reauthorized programs would reduce net 
discretionary outlays by $14 million over the 2019-2023 period, 
assuming appropriation actions consistent with the bill.
    Enacting H.R. 5554 would increase the FDA's workload 
because the legislation would expand eligibility for 
conditional approval for certain drugs. The agency's 
administrative costs also would increase because of regulatory 
activities required by a provision concerning petitions for 
additives intended for use in animal food. H.R. 5554 also would 
require the FDA to publish guidance or produce regulations on a 
range of topics, transmit a report to the Congress, and hold 
public meetings. CBO expects that the costs associated with 
those activities would not be covered by fees, and it estimates 
that implementing such provisions would cost $6 million over 
the 2019-2023 period.
    H.R. 5582, the Abuse Deterrent Access Act of 2018, would 
require the Secretary of HHS to report to the Congress on 
existing barriers to access to ``abuse-deterrent opioid 
formulations'' by Medicare Part C and D beneficiaries. Such 
formulations make the drugs more difficult to dissolve for 
injection, for example, and thus can impede their abuse. 
Assuming the availability of appropriated funds and based on 
historical spending patterns for similar activities, CBO 
estimates that implementing the legislation would cost less 
than $500,000 over the 2019-2023 period.
    H.R. 5590, the Opioid Addiction Action Plan Act, would 
require the Secretary of HHS to develop an action plan by 
January 1, 2019, for increasing access to medication-assisted 
treatment among Medicare and Medicaid enrollees. The bill also 
would require HHS to convene a stakeholder meeting and issue a 
request for information within three months of enactment, and 
to submit a report to the Congress by June 1, 2019. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5590 would cost approximately 
$2 million over the 2019-2023 period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
FDA to require certain packaging and disposal technologies, 
controls, or measures to mitigate the risk of abuse and misuse 
of drugs. Based on information from the FDA, CBO estimates that 
implementing H.R. 5687 would not significantly affect spending 
over the 2019-2023 period. This bill would also require that 
the GAO study the effectiveness and use of packaging 
technologies for controlled substances--a provision that CBO 
estimates would cost less than $500,000.
    H.R. 5715, the Strengthening Partnerships to Prevent Opioid 
Abuse Act, would require the Secretary of HHS to establish a 
secure Internet portal to allow HHS, Medicare Advantage plans, 
and Medicare Part D plans to exchange information about fraud, 
waste, and abuse among providers and suppliers no later than 
two years after enactment. H.R. 5715 also would require 
organizations with Medicare Advantage contracts to submit 
information on investigations related to providers suspected of 
prescribing large volumes of opioids through a process 
established by the Secretary no later than January 2021. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5715 would cost approximately 
$9 million over the 2019-2023 period.
    H.R. 5789, a bill to require the Secretary of Health and 
Human Services to issue guidance to improve care for infants 
with neonatal abstinence syndrome and their mothers, and to 
require the Comptroller General of the United States to conduct 
a study on gaps in Medicaid coverage for pregnant and 
postpartum women with substance use disorder, would direct the 
Secretary of HHS to issue guidance to states on best practices 
under Medicaid and CHIP for treating infants with neonatal 
abstinence syndrome. H.R. 5789 also would direct the Government 
Accountability Office to study Medicaid coverage for pregnant 
and postpartum women with substance use disorders. Based on 
information from HHS and historical spending patterns for 
similar activities, CBO estimates that enacting H.R. 5789 would 
cost approximately $2 million over the 2019-2023 period.
    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would amend the Public Health Service Act so that requirements 
pertaining to the confidentiality and disclosure of medical 
records relating to substance use disorders align with the 
provisions of the Health Insurance Portability and 
Accountability Act of 1996. The bill would require the Office 
of the Secretary of HHS to issue regulations prohibiting 
discrimination based on data disclosed from such medical 
records, to issue regulations requiring covered entities to 
provide written notice of privacy practices, and to develop 
model training programs and materials for health care providers 
and patients and their families. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 5795 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct 
the Medicaid and CHIP Payment and Access Commission to study 
institutions for mental diseases in a representative sample of 
states. Based on information from the commission about the cost 
of similar work, CBO estimates that implementing H.R. 5800 
would cost about $1 million over the 2019-2023 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers. The bill also would mandate two studies of Medicare 
coding and payments arising from enactment of this legislation. 
Based on the cost of similar activities, CBO estimates that 
those reports would cost $1 million over the 2019-2023 period. 
(If enacted, H.R. 5804 also would affect mandatory spending; 
see Table 1.)
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would allow the FDA to require that pharmaceutical 
manufacturers study certain drugs after they are approved to 
assess any potential reduction in those drugs' effectiveness 
for the conditions of use prescribed, recommended, or suggested 
in labeling. CBO anticipates that implementing H.R. 5811 would 
not significantly affect the FDA's costs over the 2019-2023 
period.
    Other Authorizations. The following nine bills would 
increase authorization levels, but CBO has not completed 
estimates of amounts. All authorizations would be subject to 
future appropriation action.
           H.R. 4284, Indexing Narcotics, Fentanyl, and 
        Opioids Act of 2017
           H.R. 5002, Advancing Cutting Edge Research 
        Act
           H.R. 5228, Stop Counterfeit Drugs by 
        Regulating and Enhancing Enforcement Now Act (see Table 
        1 for an estimate of the revenue effects of H.R. 5228)
           H.R. 5752, Stop Illicit Drug Importation Act 
        of 2018 (see Table 1 for an estimate of the revenue 
        effects of H.R. 5752)
           H.R. 5799, Medicaid DRUG Improvement Act 
        (see Table 1 for an estimate of the direct spending 
        effects of H.R. 5799)
           H.R. 5801, Medicaid Providers and 
        Pharmacists Are Required to Note Experiences in Record 
        Systems to Help In-Need Patients (PARTNERSHIP) Act (see 
        Table 1 for an estimate of the direct spending effects 
        of H.R. 5801)
           H.R. 5806, 21st Century Tools for Pain and 
        Addiction Treatments Act
           H.R. 5808, Medicaid Pharmaceutical Home Act 
        of 2018 (see Table 1 for an estimate of the direct 
        spending effects of H.R. 5808)
           H.R. 5812, Creating Opportunities that 
        Necessitate New and Enhanced Connections That Improve 
        Opioid Navigation Strategies Act (CONNECTIONS) Act
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. Twenty-two of the bills discussed in this document 
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending 
and revenues in those bills can be found in Table 1.
    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 4998, the Health Insurance for 
Former Foster Youth Act, would increase net direct spending by 
more than $2.5 billion and on-budget deficits by more than $5 
billion in at least one of the four consecutive 10-year periods 
beginning in 2029.
    CBO estimates that none of the remaining 58 bills included 
in this estimate would increase net direct spending by more 
than $2.5 billion or on-budget deficits by more than $5 billion 
in any of the four consecutive 10-year periods beginning in 
2029.
    Mandates: One of the 59 bills included in this document, 
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the 
costs of that bill's mandates on public and private entities 
would fall below UMRA's thresholds ($80 million and $160 
million, respectively, for public- and private-sector entities 
in 2018, adjusted annually for inflation).
    In addition, five bills would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of those bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would fall below the UMRA threshold. Because CBO 
does not know how federal agencies would implement new 
authority granted in the other two of those five bills, H.R. 
5228 and 5687, CBO cannot determine whether the costs of their 
mandates would exceed the threshold.
    For large entitlement grant programs, including Medicaid 
and CHIP, UMRA defines an increase in the stringency of 
conditions on states or localities as an intergovernmental 
mandate if the affected governments lack authority to offset 
those costs while continuing to provide required services. 
Because states possess significant flexibility to alter their 
responsibilities within Medicaid and CHIP, the requirements 
imposed by various bills in the markup on state administration 
of those programs would not constitute mandates as defined in 
UMRA.

Mandates Affecting Public and Private Entities

    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would impose intergovernmental and private-sector mandates by 
requiring entities that provide treatment for substance use 
disorders to notify patients of their privacy rights and also 
to notify patients in the event that the confidentiality of 
their records is breached. In certain circumstances, H.R. 5795 
also would prohibit public and private entities from denying 
entry to treatment on the basis of information in patient 
health records. Those requirements would either supplant or 
narrowly expand responsibilities under existing law, and 
compliance with them would not impose significant additional 
costs. CBO estimates that the costs of the mandates would fall 
below the annual thresholds established in UMRA.

Mandates Affecting Private Entities

    Five bills included in this document would impose private-
sector mandates:
    H.R. 5228, the Stop Counterfeit Drugs by Regulating and 
Enhancing Enforcement Now Act, would require drug distributors 
to cease distributing any drug that the Secretary of HHS 
determines might present an imminent or substantial hazard to 
public health. CBO cannot determine what drugs could be subject 
to such an order nor can it determine how private entities 
would respond. Consequently, CBO cannot determine whether the 
aggregate cost of the mandate would exceed the annual threshold 
for private-sector mandates.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would require developers 
and manufacturers of OTC drugs to pay certain fees to the FDA. 
CBO estimates that about $30 million would be collected each 
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual 
threshold for private-sector mandates in any year during that 
period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018 would require developers and manufacturers 
of brand-name and generic veterinary drugs to pay application, 
product, establishment, and sponsor fees to the FDA. CBO 
estimates that about $51 million would be collected annually, 
on average, for a total of $257 million over the 2019-2023 
period. Those amounts would not exceed the annual threshold for 
private-sector mandates in any year during that period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
Secretary of HHS to require drug developers and manufacturers 
to implement new packaging and disposal technology for certain 
drugs. Based on information from the agency, CBO expects that 
the Secretary would use the new regulatory authority provided 
in the bill; however, it is uncertain how or when those 
requirements would be implemented. Consequently, CBO cannot 
determine whether the aggregate cost of the mandate would 
exceed the annual threshold for private entities.
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would expand an existing mandate that requires drug developers 
to conduct postapproval studies or clinical trials for certain 
drugs. Under current law, in certain instances, the FDA can 
require studies or clinical trials after a drug has been 
approved. H.R. 5811 would permit the FDA to use that authority 
if the reduction in a drug's effectiveness meant that its 
benefits no longer outweighed its costs. CBO estimates that the 
incremental cost of the mandate would fall below the annual 
threshold established in UMRA because of the small number of 
drugs affected and the narrow expansion of the authority that 
exists under current law.
    None of the remaining 53 bills included in this document 
would impose an intergovernmental or private-sector mandate.
    Previous CBO estimate: On June 6, 2018, CBO issued an 
estimate for seven opioid-related bills ordered reported by the 
House Committee on Ways and Means on May 16, 2018. Two of those 
bills contain provisions that are identical or similar to the 
legislation ordered reported by the Committee on Energy and 
Commerce, and for those provisions, CBO's estimates are the 
same.
    In particular, five bills listed in this estimate contain 
provisions that are identical or similar to those in several 
sections of H.R. 5773, the Preventing Addiction for Susceptible 
Seniors Act of 2018:
     H.R. 5675, which would require prescription drug 
plans to implement drug management programs, is identical to 
section 2 of H.R. 5773.
     H.R. 4841, regarding electronic prior 
authorization for prescriptions under Medicare's Part D, is 
similar to section 3 of H.R. 5773.
     H.R. 5715, which would mandate the creation of a 
new Internet portal to allow various stakeholders to exchange 
information, is identical to section 4 of H.R. 5773.
     H.R. 5684, which would expand medication therapy 
management, is the same as section 5 of H.R. 5773.
     H.R. 5716, regarding prescriber notification, is 
identical to section 6 of H.R. 5773.
    In addition, in this estimate, a provision related to 
Medicare beneficiary education in H.R. 5686, the Medicare Clear 
Health Options in Care for Enrollees Act of 2018, is the same 
as a provision in section 2 of H.R. 5775, the Providing 
Reliable Options for Patients and Educational Resources Act of 
2018, in CBO's estimate for the Committee on Ways and Means.
    Estimate prepared by: Federal Costs: Rebecca Yip (Centers 
for Disease Control and Prevention), Mark Grabowicz (Drug 
Enforcement Agency), Julia Christensen, Ellen Werble (Food and 
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health 
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee, 
Rebecca Yip (Medicare), Philippa Haven (National Institutes of 
Health), Alice Burns, Andrea Noda (Office of the Secretary of 
the Department of Health and Human Services), Philippa Haven, 
Lori Housman, Emily King (Substance Abuse and Mental Health 
Services Administration, Health Resources and Services 
Administration); Federal Revenues: Jacob Fabian, Peter Huether, 
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate 
Kelly; Mandates: Andrew Laughlin.
    Estimate reviewed by: Tom Bradley, Chief, Health Systems 
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates 
Unit; Sarah Masi, Special Assistant for Health; Susan Willie, 
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for 
Budget Analysis; Theresa A. Gullo, Assistant Director for 
Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to require 
states to operate a drug management program for at-risk 
beneficiaries that identifies Medicaid beneficiaries at-risk 
for substance use disorder and assigns them to a pharmaceutical 
home program. The pharmaceutical home program must set 
reasonable limits on the number of prescribers and dispensers 
that beneficiaries may utilize.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 5808 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. 5808 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. 5808 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 
``Medicaid Pharmaceutical Home Act of 2018.''

Section 2. Drug management program for at-risk beneficiaries

    Section 2 would amend section 1927A of the Social Security 
Act to require states to operate a qualified drug management 
program under which a State may enroll certain at-risk 
beneficiaries identified by the State by January 1, 2020.

         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

           *       *       *       *       *       *       *


SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.

  (a) In General.--Beginning January 1, 2020, a State shall 
operate a qualified drug management program under which a State 
may enroll certain at-risk beneficiaries identified by the 
State under the program.
  (b) Qualified Drug Management Program.--For purposes of this 
section, the term ``qualified drug management program'' means, 
with respect to a State, a program carried out by the State 
(including through a contract with a pharmacy benefit manager) 
that provides at least for the following:
          (1) Identification of at-risk individuals.--Under the 
        program, the State identifies, in accordance with 
        subsection (c), individuals enrolled under the State 
        plan (or waiver of the State plan) who are at-risk 
        beneficiaries.
          (2) Elements of program.--
                  (A) In general.--Under the program, the 
                State, with respect to each individual 
                identified under paragraph (1) and enrolled 
                under the program under paragraph (5)--
                          (i) subject to subparagraphs (B) and 
                        (C), selects at least one, but not more 
                        than three, health care providers and 
                        at least one, but not more than three, 
                        pharmacies for each such individual for 
                        purposes of clause (ii), in accordance 
                        with a selection process that takes 
                        into account reasonable factors such as 
                        the individual's previous utilization 
                        of items and services from health care 
                        providers and pharmacies, geographic 
                        proximity of the individual to such 
                        health care providers and pharmacies, 
                        access of the individual to health 
                        care, reasonable travel time, 
                        information regarding housing status, 
                        and any known preference of the 
                        individual for a certain health care 
                        provider or pharmacy; and
                          (ii) requires that any controlled 
                        substance furnished to such individual 
                        during the period for which such 
                        individual is enrolled under the 
                        program be prescribed by a health care 
                        provider selected under clause (i) for 
                        such individual and dispensed by a 
                        pharmacy selected under clause (i) for 
                        such individual in order for such 
                        controlled substance to be covered 
                        under the State plan (or waiver).
                  (B) Beneficiary preference.--In the case of 
                an individual receiving a notice under 
                paragraph (3)(A) of being identified as 
                potentially being an at-risk beneficiary 
                described in such paragraph, such individual 
                may submit, during the 30-day period following 
                receipt of such notice, preferences for which 
                health care providers and pharmacies the 
                individual would prefer the State to select 
                under subparagraph (A). The State shall select 
                or change the selection of health care 
                providers and pharmacies under subparagraph (A) 
                for the individuals based on such preferences, 
                except that in the case that State determines 
                that such selection (or change of selection) of 
                a health care provider or pharmacy under 
                subparagraph (A) is contributing or would 
                contribute to prescription drug abuse or drug 
                diversion by the individual, the State may 
                select or change the selection of health care 
                provider or pharmacy for the individual without 
                regard to the preferences of the individual 
                described in this subparagraph. If the State 
                selects or changes the selection pursuant to 
                the preceding sentence without regard to the 
                preferences of the individual, the State shall 
                provide the individual with at least 30 days 
                written notice of the selection or change of 
                selection and a rationale for the selection or 
                change.
                  (C) Treatment of pharmacy with multiple 
                locations.--For purposes of subparagraph 
                (A)(i), in the case of a pharmacy that has 
                multiple locations that share real-time 
                electronic prescription data and the same chain 
                identification number, all such locations of 
                the pharmacy shall collectively be treated as 
                one pharmacy.
                  (D) Treatment of existing ffs drug management 
                programs.--In the case of a patient review and 
                restriction program (as identified in the 
                annual report submitted to the Secretary under 
                section 1927(g)(3)(D)) operated by a State 
                pursuant to section 1915(a)(2) before the date 
                of the enactment of this section, such program 
                shall be treated as a qualified drug management 
                program.
                  (E) Reasonable access.--The program shall 
                ensure, including through waiver of elements of 
                the program (including under subparagraph 
                (A)(ii)), reasonable access to health care 
                (including access to health care providers and 
                pharmacies with respect to prescription drugs 
                described in subparagraph (A)) in the case of 
                individuals with multiple residences, in the 
                case of natural disasters and similar 
                situations, and in the case of the provision of 
                emergency services (as defined for purposes of 
                section 1860D-4(c)(5)(D)(ii)(II)).
          (3) Notification to identified individuals.--Under 
        the program, the State provides each individual who is 
        identified under paragraph (1), prior to enrolling such 
        individual under the program, at least one notification 
        of each of the following:
                  (A) Notice that the State has identified the 
                individual as potentially being an at-risk 
                beneficiary for abuse or misuse of a controlled 
                substance.
                  (B) The name, address, and contact 
                information of each health care provider and 
                pharmacy that may be selected for the 
                individual under paragraph (2)(A).
                  (C) Information describing all State and 
                Federal public health resources that are 
                designed to address such abuse or misuse to 
                which the individual has access, including 
                mental health services and other counseling 
                services.
                  (D) Notice of, and information about, the 
                right of the individual to--
                          (i) submit preferences of the 
                        individual for health care providers 
                        and pharmacies to be selected under 
                        paragraph (2)(A), including as 
                        described in paragraph (2)(B);
                          (ii) appeal under paragraph (4)--
                                  (I) such identification 
                                described in subparagraph (A); 
                                and
                                  (II) the selection of health 
                                care providers and pharmacies 
                                under paragraph (2)(A).
                  (E) An explanation of the meaning and 
                consequences of the identification of the 
                individual as potentially being an at-risk 
                beneficiary for abuse or misuse of a controlled 
                substance, including an explanation of the 
                program.
                  (F) Information, including a contact list and 
                clear instructions, that explain how the 
                individual can contact the appropriate entities 
                administering the program in order to submit 
                preferences described in paragraph (2)(B) and 
                any other communications relating to the 
                program.
          (4) Appeals process.--Under the program, the State 
        provides for an appeals process under which, with 
        respect to an individual identified under paragraph 
        (1)--
                  (A) such individual may appeal--
                          (i) such identification; and
                          (ii) the selection of a health care 
                        provider or pharmacy under paragraph 
                        (2)(A);
                  (B) in the case of an appeal described in 
                subparagraph (A)(ii), the State shall 
                accommodate the health care provider or 
                pharmacy preferred by the individual for 
                selection for purposes of paragraph (2)(A), 
                unless the State determines that a change to 
                the selection of health care provider or 
                pharmacy under such paragraph is contributing 
                or would contribute to prescription drug abuse 
                or drug diversion by the individual;
                  (C) such individual is provided a period of 
                not less than 30 days following the date of 
                receipt of the notice described in paragraph 
                (3) to submit such appeal; and
                  (D) the State must make a determination with 
                respect to an appeal described in subparagraph 
                (A), and notify the individual of such 
                determination, prior to enrollment of such 
                individual in the program.
          (5) Enrollment.--Under the program, the State 
        initially enrolls individuals who are identified under 
        paragraph (1) in the program for a 12-month period--
                  (A) in the case of such an individual who 
                does not submit an appeal under paragraph (4) 
                within the period applied by the State pursuant 
                to subparagraph (C) of such paragraph, 
                beginning on the day after the last day of such 
                period; and
                  (B) in the case of such an individual who 
                does submit an appeal under paragraph (4) 
                within the period applied by the State pursuant 
                to subparagraph (C) of such paragraph but such 
                appeal is denied, beginning not later than 30 
                days after the date of such denial.
          (6) Notification of health care providers and 
        pharmacies.--Under the program, the State provides to 
        each health care provider and pharmacy selected for an 
        individual under paragraph (2)--
                  (A) notification that the individual is an 
                at-risk beneficiary enrolled under the program 
                and that the provider or pharmacy has been 
                selected for the individual under paragraph 
                (2);
                  (B) information on such program and the role 
                of being so selected; and
                  (C) a process through which the provider or 
                pharmacy can submit a concern or complaint with 
                respect to being so selected and refuse to be a 
                provider or pharmacy so selected.
          (7) Continuation of enrollment.--Under the program, 
        the State, with respect to an individual enrolled under 
        the program, provides for a process to--
                  (A) not later than 30 days before the end of 
                the 12-month period for which the individual is 
                so enrolled pursuant to paragraph (5)--
                          (i) assess, in accordance with 
                        publicly available evidence-based 
                        guidelines, whether or not such 
                        individual should continue to be 
                        enrolled under the program; and
                          (ii) notify such individual of the 
                        results of the assessment under clause 
                        (i);
                  (B) continue, subject to subparagraph (C), 
                enrollment of such individual if such 
                assessment recommends such continuation; and
                  (C) appeal the continuation of enrollment in 
                accordance with the appeals process described 
                in paragraph (4).
  (c) At-Risk Beneficiary.--
          (1) Identification.--For purposes of this section, a 
        State shall identify an individual enrolled under the 
        State plan (or waiver of the State plan) as an at-risk 
        beneficiary if the individual is not an exempted 
        individual described in paragraph (2) and--
                  (A) is identified as such an at-risk 
                beneficiary through the use of publicly 
                available evidence-based guidelines that 
                indicate misuse or abuse of a controlled 
                substance; or
                  (B) the State received notification from a 
                PDP sponsor or Medicare Advantage organization 
                that such individual was identified as being an 
                at-risk beneficiary for prescription drug abuse 
                for enrollment in a drug management program 
                established by the sponsor or organization 
                pursuant to section 1860D-4(c)(5) and such 
                identification has not been terminated under 
                subparagraph (F) of such section.
          (2) Exempted individual described.--For purposes of 
        paragraph (1), an exempted individual described in this 
        paragraph is an individual who--
                  (A) is receiving--
                          (i) hospice or palliative care; or
                          (ii) treatment for cancer;
                  (B) is a resident of a long-term care 
                facility, of a facility described in section 
                1905(d), or of another facility for which 
                frequently abused drugs are dispensed for 
                residents through a contract with a single 
                pharmacy; or
                  (C) the State elects to treat as an exempted 
                individual for purposes of paragraph (1).
  (d) Application of Privacy Rules Clarification.--The 
Secretary shall clarify privacy requirements, including 
requirements under the regulations promulgated pursuant to 
section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), related to 
the sharing of data under subsection (b)(6) in the same manner 
as the Secretary is required under subparagraph (J) of section 
1860D-4(c)(5) to clarify privacy requirements related to the 
sharing of data described in such subparagraph.
  (e) Reports.--
          (1) Annual reports.--A State operating a qualified 
        drug management program shall include in the annual 
        report submitted to the Secretary under section 
        1927(g)(3)(D), beginning with such reports submitted 
        for 2021, the following information:
                  (A) The number of individuals enrolled under 
                the State plan (or waiver of the State plan) 
                who are enrolled under the program and the 
                percentage of individuals enrolled under the 
                State plan (or waiver) who are enrolled under 
                such program.
                  (B) The number of prescriptions for 
                controlled substances that were dispensed per 
                month during each such year per individual 
                enrolled under the program, including the 
                dosage and pill count for each such 
                prescription.
                  (C) The number of pharmacies filling 
                prescriptions for controlled substances for 
                individuals enrolled under such program.
                  (D) The number of health care providers 
                writing prescriptions for controlled substances 
                (other than prescriptions for a refill) for 
                individuals enrolled under such program.
                  (E) Any other data that the Secretary may 
                require.
                  (F) Any report submitted by a managed care 
                entity under subsection (e)(2) with respect to 
                years.
        For each such report for a year after 2021, the 
        information described in this paragraph shall be 
        provided in a manner that compares such information 
        with respect to the prior calendar year to such 
        information with respect to the second prior calendar 
        year.
          (2) MACPAC reports and review.--Not later than two 
        years after the date of the enactment of this section, 
        the Medicaid and CHIP Payment and Access Commission (in 
        this section referred to as ``MACPAC''), in 
        consultation with the National Association of Medicaid 
        Directors, pharmacy benefit managers, managed care 
        organizations, health care providers (including 
        pharmacists), beneficiary advocates, and other 
        stakeholders, shall publish a report that includes--
                  (A) best practices for operating drug 
                management programs, based on a review of a 
                representative sample of States administering 
                such a program;
                  (B) a summary of the experience of the 
                appeals process under drug management programs 
                operated by several States, such as the 
                frequency at which individuals appealed the 
                identification of being an at-risk individual, 
                the frequency at which individuals appealed the 
                selection of a health care provider or pharmacy 
                under such a program, the timeframes for such 
                appeals, a summary of the reasons for such 
                appeals, and the design of such appeals 
                processes;
                  (C) a summary of trends and the effectiveness 
                of qualified drug management programs operated 
                under this section; and
                  (D) recommendations to States on how 
                improvements can be made with respect to the 
                operation of such programs.
        In reporting on State practices, the MACPAC shall 
        consider how such programs have been implemented in 
        rural areas, under fee-for-service as well as managed 
        care arrangements, and the extent to which such 
        programs have resulted in increased efficiencies to 
        such States or to the Federal Government under this 
        title.
          (3) Report on plan for coordinated care.--Not later 
        than January 1, 2021, each State operating a qualified 
        drug management program shall submit to the 
        Administrator of the Centers for Medicare & Medicaid 
        Services a report on how such State plans to provide 
        coordinated care for individuals enrolled under the 
        State plan (or waiver of the State plan) and--
                  (A) who are enrolled under the program; or
                  (B) who are enrolled with a managed care 
                entity and enrolled under such a qualified drug 
                management program operated by such entity.
  (f) Applicability to Managed Care Entities.--
          (1) In general.--With respect to any contract that a 
        State enters into on or after January 1, 2020, with a 
        managed care entity (as defined in section 
        1932(a)(1)(B)) pursuant to section 1903(m), the State 
        shall, as a condition of the contract, require the 
        managed care entity--
                  (A) to operate a qualified drug management 
                program (as defined in subsection (b)) for at-
                risk beneficiaries who are enrolled with such 
                entity and identified by the managed care 
                entity by means of application of paragraph 
                (2);
                  (B) to submit to the State an annual report 
                on the matters described in subparagraphs (A) 
                through (E) of subsection (e)(1); and
                  (C) to submit to the State a list (and as 
                necessary update such list) of individuals 
                enrolled with such entity under the qualified 
                drug management program operated by such entity 
                under subparagraph (A) for purposes of allowing 
                State plans for which medical assistance is 
                paid on a fee-for-service basis to have access 
                to such information.
          (2) Application.--For purposes of applying, with 
        respect to a managed care entity--
                  (A) under paragraph (1)(A)--
                          (i) the definition of the term 
                        ``qualified drug management program'' 
                        under subsection (b), other than 
                        paragraph (2)(D) of such subsection; 
                        and
                          (ii) the provisions of paragraphs (1) 
                        and (2) of subsection (c); and
                  (B) under paragraph (1)(B), the report 
                requirements described in subparagraphs (A) 
                through (E) of subsection (e)(1);
        each reference in such subsection (b) and paragraphs of 
        subsection (c) to ``a State'' or ``the State'' (other 
        than to ``a State plan'' or ``the State plan'') shall 
        be deemed a reference to the managed care entity, each 
        reference under such subsection, paragraphs, or 
        subparagraphs to individuals enrolled under the State 
        plan (or waiver of the State plan) shall be deemed a 
        reference to individuals enrolled with such entity, and 
        each reference under such subsection, paragraphs, or 
        subparagraphs to individuals enrolled under the 
        qualified drug management program operated by the State 
        shall be deemed a reference to individuals enrolled 
        under the qualified drug management program operated by 
        the managed care entity.
  (g) Controlled Substance Defined.--For purposes of this 
section, the term ``controlled substance'' means a drug that is 
included in schedule II, III, or IV of section 202(c) of the 
Controlled Substances Act, or any combination thereof, as 
specified by the State.

           *       *       *       *       *       *       *


                            ADDITIONAL VIEWS

    Currently, many states operate one, or more, patient review 
and restriction program. As such, it is of critical importance, 
as outlined by the National Association of Counties\1\ and 
other stakeholders, that these programs are properly financed 
and that there is oversight and monitoring to ensure no adverse 
beneficiary impact. In the event of enactment, the Minority 
notes the importance of careful implementation that prioritizes 
the needs of Medicaid beneficiaries and stringently enforces 
notifications and appeals requirements on states.
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    \1\NNACo Legislative Analysis, ``Opioid Legislation in the 115th 
Congress,'' May 2018. Available at: http://www.naco.org/sites/default/
files/documents/Final%20-%20Opioid%20Legislative %20Analysis%20-
%2005.31.2018.pdf
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                                        Frank Pallone, Jr.,
                                                    Ranking Member.

                                  [all]