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[Senate Report 115-284]
[From the U.S. Government Publishing Office]

                                                       Calendar No. 484
115th Congress       }                      {                 Report
                                 SENATE
 2d Session          }                      {                  115-284

======================================================================

 
HELPING TO END ADDICTION AND LESSEN (HEAL) SUBSTANCE USE DISORDERS ACT 
                                OF 2018

                                _______
                                

                 June 25, 2018.--Ordered to be printed

                                _______
                                

               Mr. Hatch, from the Committee on Finance, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 3120]

    The Committee on Finance, having considered an original 
bill (S. 3120) to amend titles XVIII and XIX of the Social 
Security Act to help end addictions and lessen substance abuse 
disorders, and for other purposes, reports favorably thereon 
without amendment and recommends that the bill do pass.

                                CONTENTS

                                                                   Page
 I. LEGISLATIVE BACKGROUND............................................1
II. EXPLANATION OF THE BILL...........................................3
        A. Amend Titles XVIII and XIX of the Social Security Act 
            To Help End Addictions and Lessen Substance Use 
            Disorders, and for Other Purposes....................     3
III.BUDGET EFFECTS OF THE BILL.......................................26

IV. VOTES OF THE COMMITTEE...........................................26
 V. REGULATORY IMPACT AND OTHER MATTERS..............................26
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED............27

                       I. LEGISLATIVE BACKGROUND

    The Committee on Finance, having considered S. 3120, a bill 
to amend titles XVIII and XIX of the Social Security Act to 
help end addictions and lessen substance abuse disorders, and 
for other purposes, reports favorably thereon and recommends 
that the bill do pass.

Background and need for legislative action

    Medicare is a federal program that provides health 
insurance coverage for individuals aged 65 and older, certain 
individuals under the age of 65 who have disabilities, and 
those with End Stage Renal Disease. Medicare also pays for 
certain services for individuals dually eligible for both 
Medicare and Medicaid. Medicare consists of four parts: Part A 
covers inpatient hospital and other facility-based services; 
Part B covers physician visits and other outpatient-based care; 
Part C, or Medicare Advantage, covers the same Part A and Part 
B services (and some supplemental services) through private 
insurance companies; and Part D covers prescription drugs 
through private prescription drug plan sponsors. Medicare 
covers services that are ``reasonable and necessary''.
    Thus, Medicare covers opioids and other drugs prescribed by 
a physician and covered by the Part D plans. In 2016, one in 
three Medicare beneficiaries received at least one opioid 
prescription, resulting in over $4 billion in Part D program 
spending.\1\ Medicare also covers a range of services related 
to the diagnosis, evaluation and treatment of opioid and other 
substance use disorders, as well as non-opioid treatments. 
While medications and services along the continuum of care are 
generally covered for inpatients and in certain outpatient 
settings, there are opportunities to expand access to 
clinically appropriate medications and services for Medicare 
beneficiaries. In addition, there are opportunities to increase 
the focus on the opioid epidemic and to promote the best 
possible treatment determined by clinical guidelines and 
judgment.
---------------------------------------------------------------------------
    \1\Data Brief: Opioids in Medicare Part D: Concerns about Extreme 
Use and Questionable Prescribing Office of Inspector General, 
Department of Health and Human Services, July 2017.
---------------------------------------------------------------------------
    Medicaid is a joint federal-state program that finances the 
delivery of primary and acute medical services, as well as 
long-term services and supports, for a diverse low-income 
population. Each state has a Medicaid state plan that describes 
how the state will administer its program. The benefits covered 
under Medicaid include both mandatory and optional services. 
Mandatory services include inpatient hospital services, 
outpatient hospital services, and a range of services for 
infants and children under the early and periodic screening, 
diagnostic, and treatment services benefit. Optional services 
include certain non-mandatory categories of services which may 
include certain types of residential treatment, therapy, and 
counseling services as well as other services such as 
prescription drugs.
    The Medicaid program provides crucial support for many who 
suffer from substance use disorders. In 2016, 4 million 
individuals aged 12 or older with a substance use disorder were 
covered by Medicaid.\2\ State Medicaid programs provide a range 
of services to treat substance use disorder (SUD), such as 
counseling, medication-assisted treatment (MAT), and cognitive 
behavioral therapy. However, gaps remain in some states' 
continuum of care, and access to care for Medicaid 
beneficiaries can be inconsistent.
---------------------------------------------------------------------------
    \2\Substance Abuse and Mental Health Services Administration, 
``Results from the 2016 National Survey on Drug Use and Health: 
Detailed Tables.'' Table 5.9A, available at https://www.samhsa.gov/
data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf 
(including the Children's Health Insurance Program).
---------------------------------------------------------------------------
    The opioid epidemic has also had a significant impact on 
the child welfare system, particularly the foster care system 
which is funded under Title IV-E of the Social Security Act. 
Since 2000, the percentage of children removed from their home 
due to parental substance abuse has almost doubled, and today 
more than 1 in 3 children enter foster care for this reason.\3\ 
The number of children in foster care has also risen each year 
for the last four years, and child welfare officials report 
that the opioid epidemic is a major cause of this increase. The 
recently enacted Family First Prevention Services Act provides 
resources to states so they can provide evidence-based 
substance abuse services and other supports for parents, 
grandparents, and other kinship caregivers which will help more 
families keep their children safely at home or with relatives 
and avoid the trauma faced by children who are separated from 
their parents and placed in foster care. Because of the impact 
of the opioid epidemic on families with children, efforts to 
address the crisis should focus on the needs of families, not 
just those directly affected by substance abuse. By developing 
more effective services for these families, fewer children will 
enter foster care, and those who must be separated from their 
parents will be able to return home more quickly after their 
parents receive the help they need.
---------------------------------------------------------------------------
    \3\Child Welfare and Treatment Statistics: Prevalence of Parental 
Alcohol or Other Drug Use as a Contributing Factor for Reason for 
Removal in the United States, 2000 to 2015. HHS National Center on 
Substance Abuse and Child Welfare.
---------------------------------------------------------------------------
    On February 2, 2018, Finance Committee Chairman Orrin Hatch 
(R-UT) and Ranking Member Wyden (D-OR) released a letter 
seeking feedback from stakeholders on how to improve Congress' 
response to the opioid epidemic in Medicare, Medicaid and human 
services programs. After receiving nearly 200 stakeholder 
responses, on April 19, 2018, Chairman Hatch and Ranking Member 
Wyden convened a hearing to examine how to tackle opioid and 
substance use disorders. On May 23, 2018, the Chairman and 
Ranking Member praised the bipartisan work of Finance Committee 
members on 22 opioid bills that would make significant 
improvements in Medicare, Medicaid, and Human Services 
programs.
    On June 7, 2018, Chairman Hatch released a Chairman's Mark 
that contained the 22 bipartisan Finance Committee member 
policies. These policies, plus additional policies contained in 
the June 12, 2018, Modification to the Chairman's Mark, as well 
as two adopted amendments comprise the reported bill that is 
described below.

                      II. EXPLANATION OF THE BILL

 A. Amend Titles XVIII and XIX of the Social Security Act To Help End 
 Addictions and Lessen Substance Use Disorders, and for Other Purposes

                           TITLE I--MEDICARE

             SECTION 101: MEDICARE OPIOID SAFETY EDUCATION

Present law

    On an annual basis, the Secretary of Health & Human 
Services (HHS Secretary) is required to prepare and distribute 
a public notice that provides an explanation of Medicare 
benefits. This benefit-related overview must explain the scope 
of medical services that are--and are not--covered by Medicare. 
The annual notice must also contain information regarding 
specified Medicare beneficiary rights, responsibilities, and 
educational resources (Social Security Act (SSA) Section 1804). 
During preparation of the notice, the HHS Secretary is required 
to consult with health insurers and groups representing 
seniors. The completed notice must be delivered to all 
individuals entitled to benefits under Medicare Parts A or B.
    To meet the notice requirement, the Centers for Medicare & 
Medicaid Services (CMS) produces a ``handbook'' entitled 
Medicare & You (CMS Product No. 10050). The handbook is mailed 
to Medicare beneficiaries in late September, prior to the Part 
C Medicare Advantage (MA) and Medicare Part D open enrollment 
period. Medicare & You is also publicly available on the CMS 
website, where beneficiaries can opt out of receiving a 
physical copy of the handbook and instead choose electronic 
delivery for future releases. In addition to setting forth the 
statutory requirements, the handbook includes other Medicare 
information, such as answers to frequently asked questions and 
lists of available health and drug plans.

Explanation of provision

    The reported bill would add a new SSA Section 1804(d) 
requiring the HHS Secretary to compile and provide the 
following in the annual Medicare & You handbook for open 
enrollment periods after January 1, 2019: references to 
educational resources on opioid use and pain management; a 
description of categories of alternative, non-opioid Medicare-
covered pain management treatments; and a suggestion that 
beneficiaries talk to their physicians about opioid use and 
pain management.

SECTION 102: EXPANDING THE USE OF TELEHEALTH SERVICES FOR THE TREATMENT 
        OF OPIOID USE DISORDER AND OTHER SUBSTANCE USE DISORDERS

Present law

    Telehealth services covered for Medicare beneficiaries 
under Part B are subject to SSA Section 1834(m), which places 
restrictions on the location, provider, telehealth technology, 
and certain other parameters. The facility where the 
beneficiary is located is referred to as the originating site, 
and the site where the practitioner is located is referred to 
as the distant site. Medicare makes a payment to the physician 
or practitioner at the distant site for rendering the 
telehealth service, and a separate facility fee to the 
originating site. SSA Section 1834(m) requires that telehealth 
services must be provided from a qualifying originating site in 
a rural health professional shortage area (HPSA) or a county 
not included in a Metropolitan Statistical Area (MSA), or from 
an entity that participates in a federal telemedicine 
demonstration project. Qualifying originating sites include an 
office of a physician or practitioner, a critical access 
hospital (CAH), a rural health clinic, a federally qualified 
health center, a hospital, a hospital- or CAH-based renal 
dialysis center, a skilled nursing facility, or a community 
mental health center. Under Part C, MA plans must provide 
telehealth services to the extent that they are a covered 
service under Medicare Part B.
    Bipartisan Budget Act of 2018 (BBA 18, P.L. 115-123) 
expanded telehealth under Medicare in four ways: (1) by 
increasing the opportunities for physicians and practitioners 
participating in certain accountable care organizations (ACOs) 
to receive telehealth payments, beginning January 1, 2020 (BBA 
18 Section 50324); (2) by eliminating certain originating site 
restrictions for telehealth services for diagnosis, evaluation 
or treatment of the symptoms of an acute stroke, beginning 
January 1, 2019 (BBA 18 Section 50325); (3) by allowing MA 
plans to provide additional telehealth benefits (minus capital 
and infrastructure costs, which are treated as if they are 
benefits required under original Medicare) for payment purposes 
starting in plan year 2020 (BBA 18 Section 50323); and (4) by 
permitting Medicare patients with end-stage renal disease 
(ESRD) on home dialysis to receive monthly clinical assessments 
at home or at freestanding dialysis facilities via telehealth 
without regard to geographic location, beginning January 1, 
2019 (BBA 18 Section 50302).

Explanation of provision

    The reported bill would amend SSA Section 1834(m) to 
eliminate certain statutory originating site requirements for 
services furnished via telehealth for the purpose of treating 
substance use disorders, beginning January 1, 2019. Thus, the 
provision would allow payment for these telehealth services 
when furnished to a beneficiary at an originating site, 
including the beneficiary's home, without regard to its 
geographic location. A separate facility fee would not be 
provided if the originating site is the beneficiary's home. No 
later than five years after enactment, the HHS Secretary would 
be required to report to Congress on the impact of this 
modification on health care utilization and health outcomes 
related to substance use disorders.
    It is the intent of the Committee that nothing in this 
provision would change the existing application of State law, 
including State licensure requirements.

           SECTION 103: COMPREHENSIVE SCREENINGS FOR SENIORS

Present law

    Medicare beneficiaries are entitled to annual ``wellness'' 
visits. The first, furnished in the first year of enrollment, 
is the Initial Preventive Physical Examination (IPPE), often 
called the ``Welcome to Medicare'' visit (SSA Section 
1861(ww)). Annually thereafter, beneficiaries are entitled to 
an annual wellness visit (AWV) and personalized prevention plan 
services (SSA Section 1861(hhh)). Regulations at 42 C.F.R. Part 
410, Subpart B specify the required elements for the IPPE and 
AWV, respectively, which include the following: the provision 
of a health assessment; a suite of physical measurements (e.g., 
blood pressure); education, counseling, and referral for 
additional preventive services that are covered separately; and 
consultative services, such as end-of-life planning (upon 
agreement with the patient) and screenings for depression and 
alcohol misuse.

Explanation of provision

    The reported bill would amend the authorities for the IPPE 
and AWV in SSA Section 1861 for services furnished on or after 
January 1, 2019 to include the following for each:
           A review of the beneficiary's current opioid 
        prescriptions, defined as (1) a review of potential 
        risk factors for opioid use disorder; (2) an evaluation 
        of pain severity and the treatment plan; (3) the 
        provision of information on non-opioid treatment 
        options; and (4) referral to a pain management 
        specialist, as appropriate; and
           Screening for potential substance use 
        disorders that includes a referral for treatment, as 
        appropriate.
    It is the intent of the Committee that the provision of 
information on non-opioid treatment options may include 
pharmacologic and non-pharmacologic options, as determined 
appropriate by the physician or other eligible professional 
furnishing these services.

           SECTION 104: EVERY PRESCRIPTION CONVEYED SECURELY

Present law

    Under Medicare Part D, private insurers and other sponsors 
enter into annual contracts with CMS to provide a defined 
package of outpatient drug benefits in some or all of the 34 
Part D regions and U.S. territories. As part of program 
requirements, Part D plans must support an electronic 
prescription (e-prescribing) program, which is defined by CMS 
as the use of electronic media to transmit prescription or 
prescription-related information between a prescriber, 
dispenser, pharmacy benefit manager, and/or health plan, either 
directly or through an intermediary, including an e-prescribing 
network. Technical transmission requirements for e-prescribing 
networks are based on standards set by the National Council for 
Prescription Drug Programs (NCPDP SCRIPT) and other outside 
organizations. Physicians and pharmacies that transmit e-
prescriptions and related communications with Part D plans must 
comply with CMS standards.
    Further, the Medicare Improvements for Patients and 
Providers Act of 2008 (MIPPA, P.L. 110-275) established an 
incentive payment program to encourage physician uptake of e-
prescribing through bonus payments that transitioned to payment 
penalties after a period of time. This e-prescribing incentive 
program was sunset at the end of calendar year 2013 as 
physician e-prescribing was incorporated as a requirement into 
the broader Electronic Health Record Incentive Program, 
commonly referred to as the ``meaningful use'' program.

Explanation of provision

    The reported bill would amend SSA Section 1860D-4(e) to 
require that health care practitioners use e-prescribing for 
Part D-covered drugs that are Schedule II, III, IV, or V 
controlled substances, as classified under the Controlled 
Substances Act (P.L. 91-513), beginning on January 1, 2021.
    The HHS Secretary would be required to define 
circumstances, through rulemaking that involves public comment, 
when the requirement may be waived, including:
           cases where the prescriber and dispenser are 
        the same entity;
           a prescription that cannot be transmitted 
        electronically due to the constraints of the most 
        recently implemented version of NCPDP SCRIPT standard;
           a prescription issued by a practitioner who 
        has received a maximum one-year waiver (or renewal of a 
        waiver) of the e-prescribing requirement due to 
        demonstrated economic hardship, technological 
        limitations not reasonably within the control of the 
        practitioner, or other exceptional circumstances;
           a situation where a practitioner reasonably 
        determines that it would be impractical for the 
        individual involved to obtain substances prescribed by 
        electronic prescription in a timely manner, and such 
        delay would adversely impact the individual's medical 
        condition;
           a prescription that allows for dispensing of 
        a non-patient specific prescription pursuant to a 
        standing order, approved protocol for drug therapy, 
        collaborative drug management, or comprehensive 
        medication management, in response to a public health 
        emergency, or other circumstances;
           a prescription under a research protocol;
           a prescription that the Food and Drug 
        Administration (FDA) requires to contain certain 
        elements that cannot be accomplished with electronic 
        prescribing, such as a drug with risk evaluation and 
        mitigation strategies; and
           a prescription for an individual who 
        receives hospice care that is not covered under the 
        hospice benefit or a prescription for an individual who 
        is a resident of a nursing home and is dually eligible 
        for both Medicare and Medicaid.
    Part D sponsors and pharmacists would not be required to 
verify that prescribers have a waiver from the e-prescribing 
requirements.
    The requirements would not affect the ability of a Part D 
plan to cover, or a pharmacist to dispense, Part D drugs from 
otherwise valid written, oral, or fax prescriptions. The 
requirements also would not affect the ability of a Part D 
enrollee to designate a specific pharmacy to dispense a drug. 
The HHS Secretary has authority to set penalties for 
noncompliance, through rulemaking that involves public comment.
    It is the intent of the Committee that the HHS Secretary 
consider the status of any effort to adopt an e-prescribing 
state specific to the nursing home setting when undertaking 
rulemaking to determine the circumstances in which the e-
prescribing requirement may be waived.

  SECTION 105: STANDARDIZING ELECTRONIC PRIOR AUTHORIZATION FOR SAFE 
                              PRESCRIBING

Present law

    CMS regulations and contract provisions require that 
Medicare Part D plans' e-prescribing systems allow for the 
exchange of specific information about a prescription such as 
enrollee eligibility, plan benefits, the drug being prescribed 
or dispensed, other drugs listed in a medication history, and 
the availability of lower cost, therapeutically appropriate 
alternatives (if any). Technical transmission requirements for 
e-prescribing networks are based on the NCPDP SCRIPT standards 
and other organizations' standards. Physicians and pharmacies 
that transmit e-prescriptions and related communications 
electronically with Part D plans must comply with CMS 
standards. Congress, through MIPPA, established an incentive 
payment program to encourage physician uptake of e-prescribing 
that was sunset at the end of calendar year 2013 as the 
physician e-prescribing was added to the broader Electronic 
Health Record Incentive Program, commonly referred to as the 
``meaningful use'' program, as a required element.
    In addition, Part D plans may implement formulary-level 
safety edits for beneficiaries using high levels of opioids 
that can include prior authorization requirements. Prior 
authorization typically requires the prescriber to provide 
additional information to demonstrate that the prescription is 
clinically justified before the plan determines it will cover 
it. The latest version of the NCPDP SCRIPT allows for prior 
authorizations, but it has not yet been adopted by CMS for Part 
D transactions.

Explanation of provision

    The reported bill would amend SSA Section 1860D-4(e) to 
require that Part D e-prescribing systems allow for processing 
of formulary prior authorizations using a standard format, 
beginning no later than January 1, 2021. The standard format 
would have to provide for secure electronic transmission of (1) 
a prior authorization request from a prescribing health care 
professional for a covered Part D drug for an enrollee to the 
plan sponsor, and (2) a response from the plan to the 
prescribing professional.
    The HHS Secretary would define the technical standards for 
the electronic prior authorization format in consultation with:
           the NCDCP;
           other standard-setting organizations 
        determined by the HHS Secretary; and
           stakeholders, including plan sponsors, 
        health care professionals, and health information 
        technology software vendors.
    A facsimile, a proprietary payer portal that does not meet 
standards specified by the HHS Secretary, or an electronic form 
would not be treated as electronic transmissions.

    SECTION 106: STRENGTHENING PARTNERSHIPS TO PREVENT OPIOID ABUSE

Present law

    Medicare Part C (MA) plans and Part D prescription drug 
plans (PDPs) are required under SSA Section 1860D-4(c)(1)(D) to 
establish compliance programs to prevent, detect, and correct 
fraud, waste, and abuse. The HHS Secretary is required to 
establish contracts with Medicare Drug Integrity Contractors 
(MEDICs) to support Medicare Parts C and D program integrity 
activities. CMS, the HHS Secretary, and the MEDICs audit MA and 
PDP plans to ensure their compliance programs meet Medicare 
requirements and investigate MA and PDP reports of provider and 
supplier fraud, waste, and abuse activities. MA and PDPs may, 
but are not required to, report to the HHS Secretary or MEDICs 
information about provider or supplier fraud, waste, or abuse 
activities. The HHS Secretary may share provider and supplier 
fraud, waste, or abuse information among other MA and PDP 
plans, but is not required to disseminate that information.
    The HHS Secretary is authorized to impose civil monetary 
penalties on individuals, organizations, agencies, or other 
entities that engage in improper conduct and may also be 
required in some situations, or may elect in other situations, 
to exclude these individuals, organizations, or other entities 
from participating in federal health programs. In addition, the 
HHS Secretary may suspend provider or supplier payments based 
on credible allegations of fraud.

Explanation of provision

    The reported bill would add a new SSA Section 1859(i) 
requiring the HHS Secretary to establish a secure Internet 
website portal within two years of enactment. The HHS Secretary 
would use the website portal to communicate and facilitate data 
sharing with MA and PDP plans and MEDICs. The website portal 
would enable MA and PDP plans to refer suspicious fraud, waste, 
and abuse activities by providers and suppliers to MEDICs for 
the purpose of initiating or assisting in investigations.
    This provision would require the HHS Secretary to use the 
website portal to disseminate to MA and PDP plans information 
on providers and suppliers who were recently referred for 
fraud, waste, and abuse; were excluded or had a payment 
suspension; had their Medicare participation revoked; or had 
been subject to administrative actions for similar activities.
    The HHS Secretary would be required to specify through 
rulemaking that involves public comment what constitutes 
suspected fraud, waste, and abuse for the purposes of the 
portal.
    The HHS Secretary would be required to disseminate 
quarterly reports to MA and PDP plans on fraud, waste, and 
abuse schemes and suspicious activity trends reported through 
the website portal. The quarterly reports would be required to 
maintain the anonymity of the plans submitting information and 
to include administrative actions, opioid overprescribing 
information, and other data determined appropriate by the HHS 
Secretary, in consultation with stakeholders.
    The provision makes clear that none of the above actions 
would prohibit referrals to the HHS OIG or other law 
enforcement entities.
    The reported bill would amend SSA Section 1857(e)(4)(C) and 
1860D-4 to require MA organizations and prescription drug plans 
(PDPs) to submit to the HHS Secretary, beginning with plan year 
2021, information on credible evidence of suspected fraud and 
other actions related to inappropriate opioid prescribing. 
Before January 1, 2021, in consultation with stakeholders, the 
HHS Secretary would be required to establish a process for MA 
organizations and PDPs to submit the required information on 
inappropriate opioid prescribing. To implement the suspected 
fraud information reporting process, the HHS Secretary would be 
required to issue regulations that would define the term 
``inappropriate prescribing of opioids,'' and determine the 
information plans would be required to submit.

  SECTION 107: COMMIT TO OPIOID MEDICAL PRESCRIBER ACCOUNTABILITY AND 
                           SAFETY FOR SENIORS

Present law

    The Part D statute does not does require identification of 
practitioners who may be prescribing an excessive amount of 
opioids, as compared to their peers. CMS has recently initiated 
steps using its general administrative authority to identify 
the practitioners who prescribe significantly more opioids than 
their peers and to notify them of their ``outlier'' status. 
Additional efforts to use Part D prescription claims data to 
track practitioner opioid prescribing and patient utilization 
include:
           The CMS Overutilization Monitoring System 
        (OMS) reviews Part D prescription drug claims to 
        identify at-risk beneficiaries who are using high 
        dosages of opioids (over a specified period of time) 
        provided by multiple prescribers or pharmacies. CMS 
        uses the OMS to verify that Part D sponsors that have 
        established opioid management programs have effective 
        systems.
           A CMS determination that requires Part D 
        plans to reject prescriptions from practitioners who 
        are on a special HHS preclusion list. The preclusion 
        list, which takes effect January 1, 2019, pertains to: 
        individuals and entities whose Medicare billing and 
        participation privileges have been revoked for 
        misconduct or crimes; and individuals who have engaged 
        in behavior for which CMS could have revoked their 
        privileges had they been enrolled in Medicare.

Explanation of provision

    The reported bill would amend SSA Section 1860D-4(c)(4) to 
direct the HHS Secretary, after consultation with stakeholders, 
to establish a program that notifies Part D opioid prescribers 
identified as statistical outliers compared to their peers and 
aims to improve prescribing consistent with the medical 
evidence. The peer comparison would be made against prescribers 
in the same specialty, with the Secretary having the discretion 
to also compare within the same geographic area.
    CMS would use the National Provider Identifier (NPI), the 
unique identifier for providers used for Medicare transactions 
and other purposes, on Part D claims to assess practitioners' 
Part D prescribing patterns. Certain data would be excluded 
from the process for identifying prescribers as statistical 
outliers including: claims for Part D covered drugs for 
individuals in hospice care, claims for Part D covered drugs 
for individuals being treated for cancer, and claims by 
prescribers who are under investigation by CMS or the HHS 
Office of Inspector General (OIG).
    Using a threshold for determining what constitutes a 
statistical outlier opioid prescriber, no later than January 1, 
2021, the HHS Secretary would be required to provide annual 
notification to prescribers identified as such outliers (during 
the period that a prescriber is identified as a statistical 
outlier) including: (1) information on how a prescriber 
compares to other prescribers within the same specialty and, if 
determined appropriate by the Secretary, geographic area; (2) 
information on evidence-based opioid prescribing guidelines, 
identified with input from stakeholders; and (3) other 
information determined by the Secretary. The HHS Secretary 
could expand the required notifications to include concurrent 
prescriptions of other covered Part D drugs that may produce 
side effects when used in combination with opioids. Beginning 
five years after the notifications first go into effect, the 
Secretary could change the frequency of the notifications based 
on stakeholder input and changes in opioid prescribing 
utilization and trends.
    If the HHS Secretary were to determine that a prescriber is 
persistently identified as a statistical outlier prescriber of 
opioids, the Secretary would be required to connect the 
prescriber with an entity that provides technical or 
educational resources on opioid prescribing guidelines. A 
prescriber could be required to enroll in the program, for a 
period determined by the HHS Secretary. At least once a year, 
the HHS Secretary would be required to communicate information 
on such prescribers to Part D plan sponsors.
    In addition, the HHS Secretary would be required to make 
aggregate information on the opioid outlier prescriber program 
available on the CMS website without identifying any specific 
prescriber.

        SECTION 108: FIGHTING THE OPIOID EPIDEMIC WITH SUNSHINE

Present law

    SSA Section 1128G requires applicable drug, device, 
biological, or medical supply manufacturers that make a payment 
or other transfer of value to a ``covered recipient'' to 
annually report information on such transactions to the HHS 
Secretary. A covered recipient is defined as a physician or a 
teaching hospital, but the definition does not include 
physicians who are employees of applicable manufacturers. 
Categories of reportable payments and transfers of value 
include amounts for research, gifts, entertainment, consulting 
fees, grants, meals, or travel. Certain items are exempt from 
disclosure, including certain very small payments or transfers 
of value, samples intended for patient use, loans of a covered 
device for a short-term time period, and educational materials 
for direct patient use. Additionally, the HHS Secretary is 
generally required to have procedures in place to ensure public 
availability of submitted information, including through a 
searchable Internet website. This reporting program established 
by the HHS Secretary is referred to as the Open Payments 
program.
    Section 1128G requires applicable manufacturers to report 
the NPI of covered recipients in their submission of 
information about payments and transfers of value to the HHS 
Secretary. The statute, however, prohibits the display of NPIs 
on the Open Payments program website.

Explanation of provision

    The reported bill would amend SSA Section 1128G(e)(6) to 
expand the definition of covered recipient to encompass 
physician assistants, nurse practitioners, clinical nurse 
specialists, certified registered nurse anesthetists, and 
certified nurse midwives (excluding employees of applicable 
manufacturers). Accordingly, applicable manufacturers would be 
required to submit information on payments or other transfers 
of value to these types of health care professionals. These 
amendments would apply to information required to be submitted 
on or after January 1, 2021.
    The reported bill would also sunset the prohibition on the 
inclusion of NPIs of covered recipients on the Open Payments 
website, beginning with the display of information required to 
be submitted on or after January 1, 2021.

    SECTION 109: DEMONSTRATION TESTING COVERAGE OF CERTAIN SERVICES 
                 FURNISHED BY OPIOID TREATMENT PROGRAMS

Present law

    Opioid Treatment Programs (OTPs) provide medication-
assisted treatment (MAT) to individuals with opioid use 
disorder. MAT involves administration of medications approved 
by the Food and Drug Administration (FDA) for treating opioid 
dependence (methadone, buprenorphine, and naltrexone), provided 
along with behavioral counseling and other supportive services. 
OTPs are certified by the Substance Abuse and Mental Health 
Services Administration (SAMHSA), and there are approximately 
1,500 SAMHSA-recognized OTPs in the United States. While 
Medicare does pay for certain services deemed reasonable and 
necessary for treatment of opioid use disorder provided in 
certain outpatient settings, such as community health centers 
and physicians' offices, it does not recognize OTPs as Medicare 
providers and, thus, OTPs are not eligible to receive Medicare 
payment.

Explanation of provision

    The reported bill would add a new SSA Section 1866F 
requiring that the HHS Secretary conduct a demonstration to 
test coverage and payment for opioid use disorder treatment 
services furnished by OTP, to begin no later than January 1, 
2021 and run for a five-year period. An eligible OTP would be 
defined as a program certified by SAMHSA, accredited by an 
SAMHSA-approved entity, that submits necessary data and 
information to the HHS Secretary, and that meets other 
requirements established by the HHS Secretary. Opioid use 
disorder treatment services would include: FDA-approved opioid 
agonist and antagonist treatment medications and the dispensing 
and administration of such medications; substance use disorder 
counseling; individual and group therapy; toxicology testing; 
and other services determined appropriate by the HHS Secretary. 
An eligible OTP selected to participate in the demonstration 
would receive a bundled payment made under Part B for those 
opioid use disorder treatment services, which may vary based on 
the type of medication administered. The HHS Secretary would be 
able to consider payment rates for comparable services made by 
state Medicaid plans and TRICARE in developing the bundles. The 
HHS Secretary would be able to include up to 2,000 
beneficiaries in the demonstration at any one time. The HHS 
Secretary would be provided $5 million in funding and the 
ability to waive certain provisions in the Social Security Act 
to implement the demonstration. The HHS Secretary would provide 
a report to Congress that includes an evaluation of the 
demonstration no later than two years after its completion.

SECTION 110: ENCOURAGING APPROPRIATE PRESCRIBING FOR VICTIMS OF OPIOID 
                          OVERDOSE IN MEDICARE

Present law

    The Comprehensive Addiction Recovery Act of 2016, or CARA, 
(P.L. 114-198) provided authority to prescription drug plan 
(PDP) sponsors to establish a drug management program that 
limits enrollees at risk of prescription drug abuse to receive 
opioids (and potentially other drugs) from one (or more) 
specific prescriber and one (or more) dispensing pharmacy. CARA 
directed the HHS Secretary to use clinical guidelines that 
indicate misuse or abuse to determine when enrollees are at-
risk of prescription drug abuse, and CMS is implementing the 
program by identifying beneficiaries who are using high dosages 
of opioids (over a specified period of time) provided by 
multiple prescribers or pharmacies. CARA also required the HHS 
Secretary to undertake utilization management in Part D to 
prevent prescription drug abuse. CMS is implementing these 
requirements by integrating them with its existing 
Overutilization Monitoring System (OMS). This integration means 
that PDPs may, after first employing a case management 
approach, establish a beneficiary-specific edit that triggers 
review of the prescription before it is dispensed or require an 
enrollee to get opioids from a specific prescriber and 
pharmacy.

Explanation of provision

    The reported bill would amend Section 1860D-4(c)(5)(C) of 
the Social Security Act to require, starting no later than 
January 1, 2021, that the HHS Secretary:
           identify enrollees with a history of opioid-
        related overdose, as defined by the Secretary; and
           include such enrollees as potentially at-
        risk beneficiaries for prescription drug abuse, thus 
        including these enrollees in the CMS Overutilization 
        Monitoring System.

 SECTION 111: AUTOMATIC ESCALATION TO EXTERNAL REVIEW UNDER A MEDICARE 
        PART D DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES

Present law

    CARA provided authority to prescription drug plan (PDP) 
sponsors to establish a drug management program that limits 
enrollees at risk of prescription drug abuse to receive opioids 
(and potentially other drugs) from one (or more) specific 
prescriber and one (or more) dispensing pharmacy. CARA requires 
that PDPs provide an initial notice when an enrollee is 
identified as potentially at-risk for prescription drug abuse 
and a second notice when the enrollee is identified as at-risk 
and, thus, subject to limited access through a specific 
prescriber and pharmacy. The process generally available for 
enrollees to appeal PDP sponsor determinations involves 
multiple levels, with the initial appeal decision being made by 
the PDP before an appeal is heard by an external review entity. 
CARA provided the discretion to allow an enrollee to ``auto-
escalate'' a PDP sponsor drug management program determination 
to an external entity.

Explanation of provision

    The reported bill would amend Section 1860D-4(c)(5) to 
specify that an enrollee appeal of a PDP sponsor drug 
management program determination would be auto-escalated to an 
external entity if the PDP sponsor affirms its decision at the 
initial appeal level.

                 SECTION 112: MEDICARE IMPROVEMENT FUND

Present law

    Section 188 of the Medicare Improvements for Patient and 
Providers Act (MIPPA) established the Medicare Improvement Fund 
(MIF), available to the Secretary to make improvements under 
the original fee-for-service program under Parts A and B for 
Medicare beneficiaries. Currently, there is no funding in the 
MIF.

Explanation of provision

    The reported bill would deposit $50 million into the MIF.

                           TITLE II--MEDICAID

          SECTION 201: CARING RECOVERY FOR INFANTS AND BABIES

Present law

    Medicaid is a joint federal-state program that finances the 
delivery of primary and acute medical services, as well as 
long-term services and supports, for a diverse low-income 
population. Each state has a Medicaid state plan that describes 
how the state will administer its Medicaid program. The 
benefits covered under Medicaid (medical assistance), described 
generally in SSA Section 1905, include both mandatory and 
optional services.
    One mandatory Medicaid service is the early and periodic 
screening, diagnostic, and treatment services (EPSDT) benefit 
for children under the age of 21. EPSDT is a broad benefit 
including periodic screenings (comprehensive child health 
assessments, including physical examinations, preventive dental 
services, vision and hearing testing, appropriate 
immunizations, and laboratory tests), certain interperiodic 
screenings, diagnosis, and treatment. Treatment under EPSDT 
includes any services included as medical assistance in federal 
law that are necessary to correct or ameliorate physical and 
mental illnesses or conditions identified through the screening 
services.
    Federal law does not specifically require states to furnish 
Medicaid benefits to address neonatal abstinence syndrome 
(NAS), which is a term for withdrawal symptoms an infant may 
experience because of prenatal use of opioids or other 
substances by the mother. A United States Government 
Accountability Office report issued in October 2017, Newborn 
Health: Federal Action Needed to Address Neonatal Abstinence 
Syndrome (GAO-18-32), noted that more than 80% of NAS cases are 
paid for by Medicaid. The report found that most infants with 
NAS in the United States are treated in a hospital setting, 
often in the neonatal intensive care unit. Medicaid pays for 
this care through its inpatient hospital benefit. In addition, 
some state Medicaid programs cover treatment of NAS in 
outpatient clinics and programs or in special neonatal 
withdrawal centers.

Explanation of provision

    The reported bill would amend SSA Section 1902 in order to 
clarify that states have the option to make Medicaid services 
available on an inpatient or outpatient basis at a residential 
pediatric recovery center to infants with NAS. A residential 
pediatric recovery center would be defined as a ``center or 
facility that furnishes items and services for which medical 
assistance is available under the state plan to infants with 
the diagnosis of neonatal abstinence syndrome without any other 
significant medical risk factors.'' Covered services could 
include not only services to infants, but also services to 
mothers or other caretakers provided that those services are 
otherwise covered under the Medicaid state plan or waiver of 
such plan, such as counseling or referrals for services, 
activities to encourage caregiver-infant bonding, or training 
on caring for such infants.
    The reported bill would take effect as of the date of 
enactment, and would apply to Medicaid services furnished on or 
after that date, regardless of whether final regulations 
implementing the provision have been promulgated by that date.

      SECTION 202: PEER SUPPORT ENHANCEMENT AND EVALUATION REVIEW

Present law

    Peer support services are a behavioral health model of care 
that consists of qualified peer support providers helping 
individuals with their recovery including from substance use 
disorders. State Medicaid agencies have the option to offer 
peer support services under Medicaid. CMS' State Medicaid 
Director Letter #07-011 (Aug. 15, 2007) indicated that states 
that have chosen to cover these services have done so either 
under the Medicaid state plan, under the authority of SSA 
Section 1905(a)(13) (``other diagnostic, screening, preventive, 
and rehabilitative services''); or as part of a waiver under 
SSA Section 1915(b) or 1915(c).

Explanation of provision

    Section 202 would create a standalone requirement that the 
Comptroller General of the United States (``Comptroller 
General''), within two years after the date of enactment, 
submit a report on the provision of peer support services in 
Medicaid to Congress. The report must include information on 
state Medicaid programs' coverage of peer support services, 
including (1) the mechanisms (statutory authority or waivers) 
through which states may cover peer support; (2) the 
populations to which such coverage has been provided; (3) 
payment models used by states; and (4) federal and state 
spending. The report must also provide other information 
specified in this section relating to access to care, health 
outcomes, and costs. Finally, the report must include 
recommendations for legislative and administrative actions to 
improve access to peer support services under Medicaid.

 SECTION 203: MEDICAID SUBSTANCE USE DISORDER TREATMENT VIA TELEHEALTH

Present law

    State Medicaid programs provide for a variety of types of 
telehealth services, which can include the use of a broad range 
of electronic information and telecommunications technologies 
to support remote clinical health care, patient and 
professional health-related education, and other health care 
delivery functions.

Explanation of provision

    The reported bill would create standalone requirements for 
CMS and the Comptroller General to conduct various activities 
to evaluate and strengthen the provision of telehealth services 
in Medicaid.
    The reported bill would define various terms for purposes 
of the provision. Telehealth services would be defined broadly 
to include remote patient monitoring and other modalities such 
as live video, store-and-forward, mobile health, telephonic 
consultation, and electronic consultation. School-based health 
center would be defined the same way the term is defined for 
purposes of the State Children's Health Insurance Program 
(CHIP), in SSA Section 2110(c)(9).
    The reported bill would require CMS, within one year after 
enactment, to issue guidance to states on state options for 
federal reimbursement of states' expenditures for substance use 
disorder (SUD) services and treatment using telehealth 
including: (1) services addressing high-risk individuals 
including, at the least, American Indians and Alaska Natives, 
adults under age 40, and individuals with a history of nonfatal 
overdose; (2) provider education on providing SUD services 
using the hub and spoke model, through managed care contracts, 
through administrative claiming for disease management 
activities, and under Delivery System Reform Incentive Payment 
programs; and (3) services furnished through school-based 
health centers.
    The reported bill would require the Comptroller General to 
evaluate children's access to SUD services under Medicaid and 
submit a report summarizing the evaluation and making 
recommendations for appropriate legislative and administrative 
action to Congress within one year after enactment. The 
evaluation must include analysis of (1) options for improving 
access to and outcomes of SUD services, including by expanding 
the use of telehealth in school-based health centers, 
particularly in health professional shortage areas and 
medically underserved areas; and (2) Medicaid provider rates 
for SUD services.
    The reported bill would require CMS to issue a report to 
Congress identifying best practices and potential solutions for 
reducing barriers to the use of telehealth SUD services for 
children under Medicaid and publish it on the HHS website 
within one year after enactment.

 SECTION 204: ENHANCING PATIENT ACCESS TO NON-OPIOID TREATMENT OPTIONS

Present law

    The benefits covered under Medicaid include both mandatory 
and optional services. Examples of mandatory Medicaid services 
include inpatient hospital services, physician services, 
pregnancy-related services, services furnished by federally-
qualified health centers, and services under the EPSDT benefit 
for children under the age of 21. Examples of optional services 
under Medicaid include prescription drugs; physical, 
occupational, and speech therapies; personal care services; and 
other diagnostic, screening, preventive and rehabilitative 
services.
    State Medicaid programs vary in the scope of pain 
management services offered. All states currently offer a 
Medicaid outpatient prescription drug benefit, even though the 
benefit is optional to states. The drug benefit in general is 
broad, encompassing most prescription drugs and many non-
prescription, over-the-counter drugs. Most non-pharmacological 
pain management services, ranging from physical therapy to 
chiropractic services to acupuncture, are optional to states 
under Medicaid.

Explanation of provision

    The reported bill would create a standalone requirement 
that CMS, by January 1, 2019, issue one or more final guidance 
documents to states, or to update existing guidance documents, 
regarding mandatory and optional items and services that state 
Medicaid programs may furnish, under the state plan or a waiver 
of the state plan, for non-opioid treatment and management of 
pain, including evidence-based non-opioid pharmacological 
therapies and non-pharmacological therapies.

    SECTION 205: ASSESSING BARRIERS TO OPIOID USE DISORDER TREATMENT

Present law

    States are required to cover many health care and related 
services and supplies for Medicaid beneficiaries, though some 
services and supplies are optional benefits, such as outpatient 
prescription drugs. Even though Medicaid drug coverage is 
broad, state Medicaid programs may use drug utilization 
management tools to help administer the outpatient drug benefit 
and control drug expenditures. Physician administered drugs are 
covered under Medicaid's medical benefit, rather than the 
outpatient drug benefit. Most state Medicaid programs use a 
buy-and-bill methodology to pay for physician administered 
drugs, where physicians purchase drugs, then bill the state 
Medicaid program after the drugs are administered to Medicaid 
beneficiaries.
    SUD treatment often utilizes prescription drugs or drug 
combinations that block or reduce the effect of controlled 
substances, such as methadone, buprenorphine, and 
buprenorphine-naloxone combinations. State coverage of SUD 
treatment drugs varies, but all states cover some SUD drugs 
under some circumstances, which may be determined by a 
formulary or by prior authorization.

Explanation of provision

    The reported bill would create a standalone requirement 
that the Comptroller General study Medicaid barriers that 
impede beneficiary access to receiving SUD treatment 
medications, in particular, buprenorphine, naltrexone, and 
buprenorphine-naltrexone combination products. The Comptroller 
General would be required to study the barriers to Medicaid 
beneficiaries receiving SUD medications under various drug 
distribution models such as buy-and-bill as well as addressing 
options for Medicaid programs to use in reducing or removing 
SUD drug treatment barriers. The Comptroller General would be 
required to study SUD-treatment drug distribution models on 
purchasing, storage, and administration; pharmacist dispensing 
of SUD drugs; and ordering, prescribing, and obtaining SUD 
treatment drugs from specialty pharmacies. The Comptroller 
General would be required to evaluate how each model presents 
barriers or could be used by state Medicaid programs to reduce 
barriers to providing SUD treatments by examining what is known 
about the effect of each distribution model on Medicaid 
beneficiary access to SUD drugs, differential Medicaid costs, 
and provider willingness to provide SUD drug services. The 
Comptroller General would be required to submit a report to 
Congress on SUD barriers and to include appropriate 
recommendations for legislative and administrative action 
within 15 months of the enactment date.

                 SECTION 206: HELP FOR MOMS AND BABIES

Present law

    The scope and types of pregnancy-related services that are 
offered to pregnant women under Medicaid may vary both within 
and across states by Medicaid eligibility pathway. Pregnancy-
related services can range from pregnancy-related services 
only, to full Medicaid benefit coverage.
    Medicaid's low-income pregnancy-related eligibility 
pathways require states to provide pregnancy-related services 
to pregnant women with incomes up to 133% of the federal 
poverty level, or to pregnant women at higher income levels at 
state option. For these women (i.e., those who are Medicaid-
eligible on the basis of being pregnant), at a minimum benefit 
coverage must include prenatal care, labor and delivery, and 60 
days of postpartum care. Women who are otherwise eligible for 
Medicaid (e.g., under a low-income parent, adult, or disability 
pathway) and who become pregnant are entitled to the Medicaid 
services specified in the state plan. States may also extend 
coverage to pregnant woman through the use of the Section 1115 
waiver authority. Coverage for such women is specified in the 
waiver special terms and conditions.
    The institutions for mental disease (IMD) exclusion is a 
long-standing policy under Medicaid that prohibits the federal 
government from providing federal Medicaid matching funds to 
states for services rendered to certain Medicaid-eligible 
individuals aged 21 through 64, including pregnant women, who 
are patients in IMDs, which are institutions with more than 16 
beds that primarily provide services to persons with mental 
diseases, including substance use disorders. When a Medicaid-
eligible individual aged 21 through 64 is a patient in an IMD, 
he or she cannot receive Medicaid coverage for services 
provided inside or outside the IMD.

Explanation of provision

    The reported bill would amend SSA Section 1905(a) to permit 
states to receive federal Medicaid matching funds for otherwise 
coverable Medicaid items or services that are provided outside 
of the IMD, such as prenatal care, to a woman who (1) is 
eligible for Medicaid on the basis of being pregnant (through 
60 days postpartum); (2) is a patient in an IMD for the purpose 
of receiving treatment for a substance use disorder; and (3) 
was enrolled in Medicaid immediately before becoming a patient 
in an IMD or becomes Medicaid-eligible while a patient in an 
IMD.
    The effective date for this provision would be the date of 
enactment. If the HHS Secretary determines that state 
legislation (other than legislation appropriating funds) would 
be needed in order for the state to meet a specific statutory 
requirement for this provision, then the state plan would not 
be regarded as failing to comply with the requirement before 
the first day of the first calendar quarter beginning after the 
close of the first regular session of the state legislature 
beginning after enactment.

   SECTION 207: SECURING FLEXIBILITY TO TREAT SUBSTANCE USE DISORDERS

Present law

    The IMD exclusion is a long-standing policy under Medicaid 
that prohibits the federal government from providing federal 
Medicaid matching funds to states for services rendered to 
certain Medicaid-eligible individuals aged 21 through 64 who 
are patients in IMDs, which are defined as institutions with 
more than 16 beds, that are primarily engaged in providing 
diagnosis, treatment, or care of persons with mental diseases.
    One exception to the IMD exclusion provided through 
regulation (42 C.F.R. Sec. 438.6(e)) is that states are allowed 
to provide IMD coverage under Medicaid managed care in certain 
circumstances. Specifically, states may make monthly payments 
to managed care organizations for enrollees aged 21 through 64 
who are patients in an IMD ``in lieu of'' other services 
covered under the Medicaid state plan, as long as the length of 
stay in the IMD is no more than 15 days during the month of the 
payment. In setting managed care capitation rates, states may 
include the utilization of services at IMDs, but for the cost 
of these services, the state must use the cost of the same 
services through providers included in the Medicaid state plan 
rather than the cost of the IMD services.

Explanation of provision

    The reported bill would amend SSA Section 1903(m) to allow 
states to receive federal Medicaid payments for expenditures 
included in the development of managed care capitation rates 
for treatment described under 42 C.F.R. Section 438.6(e).

SECTION 208: MACPAC STUDY AND REPORT ON MAT UTILIZATION CONTROLS UNDER 
                        STATE MEDICAID PROGRAMS

Present law

    SUD treatment often relies on prescription drugs or drug 
combinations that block or reduce the effect of controlled 
substances. Medication-assisted treatment (MAT) is a form of 
SUD treatment that requires counseling or therapy in addition 
to prescription drugs. State Medicaid coverage of MAT drugs 
varies, but all states cover some MAT drugs under some 
circumstances. Most state Medicaid programs impose some limits 
on beneficiary access to MAT drugs through formularies or prior 
authorization requirements; states may further impose limits 
that may include restrictions on the maximum daily drug dose 
that beneficiaries may receive, duration of initial treatment, 
requirements for reassessment, and treatment plan adherence. As 
part of such utilization controls, states are required to 
provide a process for accessing a covered drug including MAT if 
otherwise medically necessary.

Explanation of provision

    The reported bill would create a standalone requirement 
that the Medicaid and CHIP Payment and Access Commission 
(MACPAC), within one year after the date of enactment, make 
publicly available a report on states' Medicaid programs for 
utilization control policies for medication-assisted treatment. 
The report must include policies for both fee-for-service and 
managed care delivery systems, and contain an inventory of 
policies related to ensuring beneficiaries' access to medically 
necessary treatment, an analysis of states' compliance with 
regulations on managed care entities' utilization controls, and 
identify states' policies that limit access to medication-
assisted treatment by limiting quantities without evaluating 
the potential for fraud, waste, or abuse.

      SECTION 209: OPIOID ADDICTION TREATMENT PROGRAMS ENHANCEMENT

Present law

    SSA Section 1903(r) requires states to operate Medicaid 
mechanized claims information retrieval systems that allow for 
the efficient and effective administration of the Medicaid 
state plan. The Balanced Budget Act of 1997 (P.L. 105-33) 
required states to submit electronic claims data, enrollee 
encounter data, and other supporting information through the 
Medicaid Statistical Information System (MSIS). The Patient 
Protection and Affordable Care Act (P.L. 111-148, as amended) 
expanded the state Medicaid data reporting requirements to 
include data elements that the HHS Secretary determines 
necessary for program integrity, program oversight, and 
administration. These additional data reporting requirements 
resulted in CMS' transition from MSIS to the Transformed-
Medicaid Statistical Information System (T-MSIS). T-MSIS 
expands the data states are required to submit to CMS to 
include information on providers, third-party payers, and 
managed care plans.
    The Freedom of Information Act (5 U.S.C. 552) requires 
agencies to publish a notice of their systems of records in the 
Federal Register for any records under control of the agency 
whereby information is retrieved by the name of an individual, 
an identifying number, or some other identifier that is 
assigned to an individual. This Federal Register notice 
outlines policies and procedures to protect the security and 
privacy of the data and is generally referred to as a System of 
Records Notice (SORN). The SORN associated with the MSIS system 
is SORN 09-70-0541, and includes information such as the kinds 
of records contained in the data system, the purpose of the 
data system, the categories of data users (e.g. federal or 
state agency or individual or organization for a research 
project), and the purpose of such uses.

Explanation of provision

    The reported bill would create a standalone requirement 
that the HHS Secretary publish a report on the prevalence of 
SUDs among Medicaid enrollees and the SUD treatment services 
provided to Medicaid enrollees, including certain specified 
information. The provision would require CMS to publish this 
report, including information for each state, and to the extent 
available, for the District of Columbia, and the five 
territories (i.e., Puerto Rico, the U.S. Virgin Islands, Guam, 
the Commonwealth of the Northern Mariana Islands, and American 
Samoa), on the agency website not later than 12 months after 
the date of enactment of this Act. CMS would be required to 
issue annual updates not later than January 1 for each calendar 
year through 2024.
    The reports would be required to rely on T-MSIS data that 
is no more than 12 months old as of the report publication 
date, and as appropriate, would be required to include 
information on data quality and completeness, including caveats 
on data limitations to inform the appropriate uses for the 
information.
    The provision would also require the HHS Secretary to 
publish a SORN in the Federal Register for the specified data 
to outline the policies and procedures to protect the security 
and privacy of the data that, at a minimum meet the MSIS system 
privacy and security policies in SORN 09-70-0541. The data 
specified in the SORN would be made available to researchers 
and states and sufficient to analyze the prevalence of SUDs and 
SUD treatment services by service type and by treatment setting 
for Medicaid enrollees in the 50 states, the District of 
Columbia, and the five territories. The HHS Secretary would be 
required to initiate the SUD data sharing activities outlined 
in the SORN no later than January 1, 2019.

      SECTION 210: BETTER DATA SHARING TO COMBAT THE OPIOID CRISIS

Present law

    Prescription drug monitoring programs (PDMPs) are statewide 
electronic databases that compile designated information on 
controlled substances generally dispensed within states. PDMP 
data are made available to individuals or organizations as 
authorized under state law; these may include prescribers, law 
enforcement officials, licensing boards, and others.
    Even though most states have PDMPs, there is no requirement 
for a state to operate a PDMP and there is considerable 
variation in how they are administered, who can access data, 
what data are collected, and other factors. In addition, there 
is variation in the underlying information technology used in 
PDMPs that can make data sharing among states difficult.
    The Health Insurance Portability and Accountability Act of 
1996 (HIPAA, P.L. 104-191) required the HHS Secretary to 
develop regulations to protect the privacy and security of 
certain health information. The privacy rule established 
standards to protect certain individual health information, 
whereas the security rule established national standards to 
protect the privacy of health information that is held or 
transferred electronically. Under HIPAA, certain stricter 
privacy requirements were established to protect individually 
identifiable information received or acquired by federally-
assisted substance abuse programs. State Medicaid programs are 
required to comply with HIPAA privacy and security provisions 
as well as to safeguard the use and disclosure of Medicaid 
beneficiary information.

Explanation of provision

    The reported bill would amend SSA Section 1903(m) to 
clarify state Medicaid programs may have reasonable access to 
one or more state-administered or accessed PDMP databases to 
the extent Medicaid program access is permitted under state 
law. In addition, as permitted under state law, the reported 
bill also clarifies that state Medicaid programs may facilitate 
reasonable access to state administered or accessed PDMP 
databases and to share the PDMP database information with 
Medicaid-enrolled providers and Medicaid managed care entities.
    Any state Medicaid program, individual, or entity that 
accessed or obtained information from PDMP databases would be 
subject to applicable state and federal security and privacy 
protections and laws. This amendment would be effective on the 
date of enactment.

   SECTION 211: MANDATORY REPORTING WITH RESPECT TO ADULT BEHAVIORAL 
                            HEALTH MEASURES

Present law

    SSA Section 1139B requires the Secretary of Health and 
Human Services to publish an initial core set of quality 
measures for adults enrolled in Medicaid, and one year after 
the publication of the core measure set, to establish the 
Medicaid Quality Measurement Program (MQMP) to award grants and 
contracts for the development, testing, and validation of 
evidence-based measures for Medicaid adults. The adult core set 
include measures related to primary care access, chronic 
conditions, and behavioral health, among other things. States 
are not required to report on these measures.

Explanation of provision

    The reported bill would amend SSA Section 1139B to require 
states to report quality measures related to behavioral health 
included in the core set of adult health quality measures 
beginning in 2024. It would also require the HHS Secretary to 
maintain such behavioral health measures within its core set 
for purposes of state reporting requirements.

   SECTION 212: REPORT ON HOUSING-RELATED SERVICES AND SUPPORTS FOR 
        INDIVIDUALS WITH SUBSTANCE USE DISORDERS UNDER MEDICAID

Present law

    States may choose to cover certain optional Medicaid 
benefits related to housing-related services and supports for 
beneficiaries, including housing transition services--such as 
assistance with housing applications and help obtaining 
resources to pay for security and utility deposits or 
furniture, housing--and tenancy sustaining services such as 
intervening when behaviors arise that could lead to eviction 
and advocacy and linkage with community resources to prevent 
eviction when housing is, or may potentially become jeopardized 
In addition, Medicaid waivers provide additional flexibility to 
states to reimburse providers for defined services that would 
otherwise not be reimbursable under Medicaid, with the approval 
of the Secretary.

Explanation of provision

    The reported bill would create a standalone requirement 
that the HHS Secretary, within one year after the date of 
enactment, issue a report on innovative initiatives and 
strategies that states may use under Medicaid to provide 
housing-related services and supports to beneficiaries with 
substance use disorders who are at risk of homelessness. The 
report would focus on successful methods and strategies to 
increase housing stability for beneficiaries with substance use 
disorders, including innovative approaches and lessons learned 
from states providing housing-related services and supports 
under Medicaid waivers, existing opportunities for States to 
provide housing-related services and supports through such 
waivers or state plan amendments, and strategies and 
partnerships developed and implemented by state Medicaid 
programs and other entities to identify and enroll eligible 
individuals with substance use disorders who are experiencing 
or are at risk of experiencing homelessness.

 SECTION 213: TECHNICAL ASSISTANCE AND SUPPORT FOR STATE STRATEGIES TO 
            PROVIDE HOUSING-RELATED SUPPORTS UNDER MEDICAID

Present law

    States may choose to cover certain optional Medicaid 
benefits related to housing-related supports and services for 
beneficiaries, including care coordination. In addition, 
Medicaid waivers provide additional flexibility to states to 
reimburse providers for defined services that would otherwise 
not be reimbursable under Medicaid, with the approval of the 
Secretary. Staff at CMS provide technical assistance to states 
on an ongoing basis on Medicaid topics.

Explanation of provision

    The reported bill would also require the HHS Secretary to 
provide technical assistance and support to states seeking to 
provide housing-related supports and services and care 
coordination services under Medicaid to beneficiaries with 
substance use disorders, and issue a report detailing an action 
plan to do so within 180 days after enactment.

                       TITLE III--HUMAN SERVICES

      SECTION 301: SUPPORTING FAMILY-FOCUSED RESIDENTIAL TREATMENT

Present law

    Under Medicaid, the federal government requires states to 
cover certain mandatory populations and benefits, but allows 
states to cover other optional populations and services. Due to 
this flexibility, there is substantial state variation in 
factors such as Medicaid eligibility and covered benefits. In 
addition, several waiver authorities (included in SSA Sections 
1115 and 1915) allow states to cover additional populations and 
services not otherwise covered under the state plan.
    The Foster Care, Prevention, and Permanency program (Title 
IV-E of the SSA, also known as the Title IV-E program) is a 
joint federal-state program that funds assistance, including 
certain case management activities, for eligible children who 
are removed from their parents and placed in foster care (for 
their safety), as well as ongoing assistance to eligible 
children leaving foster care for new permanent homes via 
adoption or legal guardianship. As amended by the Family First 
Prevention Services Act (Title VII, Division E of P.L. 115-123) 
and beginning with October 1, 2018, children in foster care who 
are residing with their parents in a licensed family-based 
residential treatment center that provides trauma-informed 
substance use disorder treatment, parenting skills training, 
parent education, and individual and family counseling, are 
eligible for Title IV-E foster care support for up to 12 
months.

Explanation of provision

    The reported bill would require the HHS Secretary, within 
180 days of enactment, to issue guidance on how states may use 
existing Medicaid and Title IV-E program authorities (including 
Medicaid waivers) to support substance use disorder treatment 
via family-focused residential treatment programs, including 
the placement of foster children with their parents in such 
programs. It would define a family-focused residential 
treatment program as a trauma-informed residential program that 
primarily provides substance use disorder treatment to pregnant 
and postpartum women, as well as parents and guardians, and 
that ``to the extent appropriate and applicable'' allows 
children to reside with such women, their parents or guardians, 
during the treatment.
    The guidance would need to discuss how funding under 
Medicaid, the Title IV-E program, and other HHS-administered 
programs can be used and coordinated to support SUD treatment 
and related services provided in a family focused residential 
treatment program. These include MAT, counseling, parenting 
training, non-emergency transportation for care of children 
residing in the program, transitional services for families 
leaving the program, and others. Before issuing the guidance, 
the HHS Secretary would need to consult with the various HHS 
divisions that administer substance use disorder or child 
welfare programs, as well as solicit input from a range of 
relevant public and private stakeholders.

        SECTION 302: IMPROVING RECOVERY AND REUNIFYING FAMILIES

Present law

    The Promoting Safe and Stable Families Program (PSSF, Title 
IV-B, Subpart 2 of the SSA) authorizes funding to states for 
the provision of services that support and preserve families, 
aid in reuniting children and their families, and promote and 
support adoption. Under SSA Section 435, the HHS Secretary is 
required to conduct evaluations of programs supported under the 
PSSF program, and may conduct evaluations of other state, 
local, or federally funded programs designed to achieve the 
same purposes as the PSSF program. Funding for this evaluation 
work is annually reserved out of capped mandatory funding, as 
well as any discretionary funding provided for the PSSF 
program.

Explanation of provision

    The reported bill would amend SSA Section 435 to authorize 
a one-time mandatory appropriation of $15 million (to remain 
available across eight years, i.e., Fiscal Year (FY) 2019-
FY2026) for the support of a ``family recovery and 
reunification program replication project.'' In carrying out 
this project, the HHS Secretary would be required to award a 
contract or grant to one or more eligible entities to conduct 
an evaluation of a family recovery and reunification program. 
The program must use a recovery coach model and include 
services and assistance designed to ensure that parents or 
guardians with a substance use disorder (and who have 
temporarily lost custody of their children) receive treatment 
and other services to support their recovery and allow them to 
be reunited with their children. Further, the HHS Secretary 
must ensure the program impacts are evaluated via a random 
assignment experiment that measures multiple relevant 
indicators (e.g., time to recovery, safety of reunifications, 
parental substance use, persistence of parental treatment 
engagement and recovery, costs, and others). Finally, in 
addition to reports on the pilot phase, impact study, and 
implementation of the family recovery and reunification 
program, the HHS Secretary would be required to publish (on an 
HHS-maintained website) a report that analyzes the program's 
impacts, and if warranted, includes a replication plan with any 
recommendations for legislative and administrative actions the 
HHS Secretary determines to be appropriate.

SECTION 303: BUILDING CAPACITY FOR FAMILY-FOCUSED RESIDENTIAL TREATMENT

Present law

    Due to the enactment of the Family First Prevention 
Services Act (Title VII, Division E of P.L. 115-123) and 
effective October 1, 2019, states may elect to use the Foster 
Care, Prevention, and Permanency program (under Title IV-E of 
the SSA) to receive a federal match for the cost of up to 12 
months of trauma-informed services to families with children at 
imminent risk of entering foster care and to pregnant or 
parenting youth in foster care. Prevention services that may be 
supported under this Title IV-E program option are trauma-
informed and evidence-based substance use and mental health 
treatment services and in-home parent skills programs, 
including parent education, parenting skills training, and 
individual and family counseling. However, to be eligible for 
Title IV-E support, the prevention services and programs 
offered must meet certain criteria that define them as 
``promising,'' ``supported'' or ``well-supported.'' Further, 
Title IV-E support for these services and programs will only be 
available to the extent that at least 50% of the total (state 
and federal) prevention spending for these activities meets the 
highest evidence standard (i.e., ``well-supported'').

Explanation of provision

    The reported bill would require the HHS Secretary to make 
grants to eligible public and private entities to develop, 
enhance or evaluate family-focused residential treatment 
programs for the purposes of increasing the availability of 
programs that meet the evidence-based practice criteria for 
Title IV-E prevention services (as added by the Family First 
Prevention Services Act). For this purpose, it would authorize 
a one-time discretionary appropriation of $20 million (to 
remain available across five years, FY2019-FY2023) and would 
require any evaluation funded (in whole or in part with these 
dollars) to be designed to help determine if the family-focused 
residential treatment program being carried out would qualify 
as ``promising,'' ``supported'' or ``well-supported'' under 
Title IV-E.
    For this purpose, the reported bill would define a 
``family-focused residential treatment program'' as a trauma-
informed residential program that primarily provides substance 
use disorder treatment to pregnant and postpartum women, as 
well as parents and guardians, and which, ``to the extent 
appropriate and applicable,'' allows children to reside with 
their parents or guardians during the treatment. Entities 
eligible to receive funding to develop, enhance or evaluate 
such programs would be defined to include state, county, local 
or tribal health or child welfare agencies; private nonprofit 
organizations; research organizations; treatment service 
providers; public or non-profit institutions of higher 
education; or other entities specified by the HHS Secretary.

                    III. BUDGET EFFECTS OF THE BILL

                         A. Committee Estimates

    In compliance with paragraph 11(a) of rule XXVI of the 
Standing Rules of the Senate and section 308(a)(1) of the 
Congressional Budget and Impoundment Control Act of 1974, as 
amended (the ``Budget Act''), the following statement is made 
concerning the estimated budget effects of the revenue 
provisions of the HEAL Act of 2018, as reported. The spending 
effects of the bill will be included in the statement from the 
Congressional Budget Office that will be provided separately, 
as described in Part C below.

                          B. Budget Authority

    In compliance with section 308(a)(1) of the Budget Act, the 
Committee states that the extent to which the provisions of the 
bill as reported involve new or increased budget authority or 
affect levels of tax expenditures will be included in the 
statement from the Congressional Budget Office that will be 
provided separately, as described in Part C below.

            C. Consultation With Congressional Budget Office

    In accordance with section 403 of the Budget Act, the 
Committee advises that the Congressional Budget Office has not 
submitted a statement on the bill. The statement from the 
Congressional Budget Office will be provided separately.

                       IV. VOTES OF THE COMMITTEE

    In compliance with paragraph 7(b) of rule XXVI of the 
Standing Rules of the Senate, the Committee states that, with a 
majority present, the Helping to End Addiction and Lessen 
(HEAL) Substance Use Disorders Act of 2018 was ordered 
favorably reported by a roll call vote of 27 ayes and 0 nays on 
June 12, 2018.

                 V. REGULATORY IMPACT AND OTHER MATTERS

                          A. Regulatory Impact

    Pursuant to paragraph 11(b) of rule XXVI of the Standing 
Rules of the Senate, the Committee makes the following 
statement concerning the regulatory impact that might be 
incurred in carrying out the provisions of the bill.

Impact on individuals and businesses, personal privacy and paperwork

    In carrying out the provisions of the bill, there is no 
expected imposition of additional administrative requirements 
or regulatory burdens on individuals or businesses. The 
provisions of the bill do not impact personal privacy.

                     B. Unfunded 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 of 1995 (P.L. 104-4), which will be provided separately.

       VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    In the opinion of the Committee, it is necessary in order 
to expedite the business of the Senate, to dispense with the 
requirements of paragraph 12 of rule XXVI of the Standing Rules 
of the Senate (relating to the showing of changes in existing 
law made by the bill as reported by the Committee).

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