[Congressional Record Volume 164, Number 148 (Thursday, September 6, 2018)]
[Senate]
[Pages S6063-S6099]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 4013. Mr. ALEXANDER submitted an amendment intended to be proposed
by him to the bill H.R. 6, to provide for opioid use disorder
prevention, recovery, and treatment, and for other purposes; which was
ordered to lie on the table; as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Opioid
Crisis Response Act of 2018''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--OPIOID CRISIS RESPONSE ACT
Sec. 1001. Definitions.
Subtitle A--Reauthorization of Cures Funding
Sec. 1101. State response to the opioid abuse crisis.
Subtitle B--Research and Innovation
Sec. 1201. Advancing cutting-edge research.
Sec. 1202. Pain research.
Sec. 1203. Report on synthetic drug use.
Subtitle C--Medical Products and Controlled Substances Safety
Sec. 1301. Clarifying FDA regulation of non-addictive pain products.
Sec. 1302. Clarifying FDA packaging authorities.
Sec. 1303. Strengthening FDA and CBP coordination and capacity.
Sec. 1304. Clarifying FDA post-market authorities.
Sec. 1305. Restricting entrance of illicit drugs.
Sec. 1306. First responder training.
Sec. 1307. Disposal of controlled substances of hospice patients.
Sec. 1308. GAO study and report on hospice safe drug management.
Sec. 1309. Delivery of a controlled substance by a pharmacy to be
administered by injection or implantation.
Subtitle D--Treatment and Recovery
Sec. 1401. Comprehensive opioid recovery centers.
Sec. 1402. Program to support coordination and continuation of care for
drug overdose patients.
Sec. 1403. Alternatives to opioids.
Sec. 1404. Building communities of recovery.
Sec. 1405. Peer support technical assistance center.
Sec. 1406. Medication-assisted treatment for recovery from addiction.
Sec. 1407. Grant program.
Sec. 1408. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use disorders.
Sec. 1409. National recovery housing best practices.
Sec. 1410. Addressing economic and workforce impacts of the opioid
crisis.
Sec. 1411. Career Act.
Sec. 1412. Pilot program to help individuals in recovery from a
substance use disorder become stably housed.
Sec. 1413. Youth prevention and recovery.
Sec. 1414. Plans of safe care.
Sec. 1415. Regulations relating to special registration for
telemedicine.
Sec. 1416. National Health Service Corps behavioral and mental health
professionals providing obligated service in schools and
other community-based settings.
Sec. 1417. Loan repayment for substance use disorder treatment
providers.
Sec. 1418. Protecting moms and infants.
Sec. 1419. Early interventions for pregnant women and infants.
Sec. 1420. Report on investigations regarding parity in mental health
and substance use disorder benefits.
Subtitle E--Prevention
Sec. 1501. Study on prescribing limits.
Sec. 1502. Programs for health care workforce.
Sec. 1503. Education and awareness campaigns.
Sec. 1504. Enhanced controlled substance overdoses data collection,
analysis, and dissemination.
Sec. 1505. Preventing overdoses of controlled substances.
Sec. 1506. CDC surveillance and data collection for child, youth, and
adult trauma.
Sec. 1507. Reauthorization of NASPER.
Sec. 1508. Jessie's law.
Sec. 1509. Development and dissemination of model training programs for
substance use disorder patient records.
Sec. 1510. Communication with families during emergencies.
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Sec. 1511. Prenatal and postnatal health.
Sec. 1512. Surveillance and education regarding infections associated
with illicit drug use and other risk factors.
Sec. 1513. Task force to develop best practices for trauma-informed
identification, referral, and support.
Sec. 1514. Grants to improve trauma support services and mental health
care for children and youth in educational settings.
Sec. 1515. National Child Traumatic Stress Initiative.
Sec. 1516. National milestones to measure success in curtailing the
opioid crisis.
TITLE II--FINANCE
Sec. 2001. Short title.
Subtitle A--Medicare
Sec. 2101. Medicare opioid safety education.
Sec. 2102. Expanding the use of telehealth services for the treatment
of opioid use disorder and other substance use disorders.
Sec. 2103. Comprehensive screenings for seniors.
Sec. 2104. Every prescription conveyed securely.
Sec. 2105. Standardizing electronic prior authorization for safe
prescribing.
Sec. 2106. Strengthening partnerships to prevent opioid abuse.
Sec. 2107. Commit to opioid medical prescriber accountability and
safety for seniors.
Sec. 2108. Fighting the opioid epidemic with sunshine.
Sec. 2109. Demonstration testing coverage of certain services furnished
by opioid treatment programs.
Sec. 2110. Encouraging appropriate prescribing under Medicare for
victims of opioid overdose.
Sec. 2111. Automatic escalation to external review under a Medicare
part D drug management program for at-risk beneficiaries.
Sec. 2112. Testing of incentive payments for behavioral health
providers for adoption and use of certified electronic
health record technology.
Sec. 2113. Medicare Improvement Fund.
Subtitle B--Medicaid
Sec. 2201. Caring recovery for infants and babies.
Sec. 2202. Peer support enhancement and evaluation review.
Sec. 2203. Medicaid substance use disorder treatment via telehealth.
Sec. 2204. Enhancing patient access to non-opioid treatment options.
Sec. 2205. Assessing barriers to opioid use disorder treatment.
Sec. 2206. Help for moms and babies.
Sec. 2207. Securing flexibility to treat substance use disorders.
Sec. 2208. MACPAC study and report on MAT utilization controls under
State Medicaid programs.
Sec. 2209. Opioid addiction treatment programs enhancement.
Sec. 2210. Better data sharing to combat the opioid crisis.
Sec. 2211. Mandatory reporting with respect to adult behavioral health
measures.
Sec. 2212. Report on innovative State initiatives and strategies to
provide housing-related services and supports to
individuals struggling with substance use disorders under
Medicaid.
Sec. 2213. Technical assistance and support for innovative State
strategies to provide housing-related supports under
Medicaid.
Subtitle C--Human Services
Sec. 2301. Supporting family-focused residential treatment.
Sec. 2302. Improving recovery and reunifying families.
Sec. 2303. Building capacity for family-focused residential treatment.
Subtitle D--Synthetics Trafficking and Overdose Prevention
Sec. 2401. Short title.
Sec. 2402. Customs fees.
Sec. 2403. Mandatory advance electronic information for postal
shipments.
Sec. 2404. International postal agreements.
Sec. 2405. Cost recoupment.
Sec. 2406. Development of technology to detect illicit narcotics.
Sec. 2407. Civil penalties for postal shipments.
Sec. 2408. Report on violations of arrival, reporting, entry, and
clearance requirements and falsity or lack of manifest.
Sec. 2409. Effective date; regulations.
TITLE III--JUDICIARY
Subtitle A--Access to Increased Drug Disposal
Sec. 3101. Short title.
Sec. 3102. Definitions.
Sec. 3103. Authority to make grants.
Sec. 3104. Application.
Sec. 3105. Use of grant funds.
Sec. 3106. Eligibility for grant.
Sec. 3107. Duration of grants.
Sec. 3108. Accountability and oversight.
Sec. 3109. Duration of program.
Sec. 3110. Authorization of appropriations.
Subtitle B--Using Data To Prevent Opioid Diversion
Sec. 3201. Short title.
Sec. 3202. Purpose.
Sec. 3203. Amendments.
Sec. 3204. Report.
Subtitle C--Substance Abuse Prevention
Sec. 3301. Short title.
Sec. 3302. Reauthorization of the Office of National Drug Control
Policy.
Sec. 3303. Reauthorization of the Drug-Free Communities Program.
Sec. 3304. Reauthorization of the National Community Anti-Drug
Coalition Institute.
Sec. 3305. Reauthorization of the High-Intensity Drug Trafficking Area
Program.
Sec. 3306. Reauthorization of drug court program.
Sec. 3307. Drug court training and technical assistance.
Sec. 3308. Drug overdose response strategy.
Sec. 3309. Protecting law enforcement officers from accidental
exposure.
Sec. 3310. COPS Anti-Meth Program.
Sec. 3311. COPS anti-heroin task force program.
Sec. 3312. Comprehensive Addiction and Recovery Act education and
awareness.
Sec. 3313. Protecting children with addicted parents.
Sec. 3314. Reimbursement of substance use disorder treatment
professionals.
Sec. 3315. Sobriety Treatment and Recovery Teams (START).
Sec. 3316. Provider education.
Sec. 3317. Demand reduction.
Sec. 3318. Anti-drug media campaign.
Sec. 3319. Technical corrections to the office of national drug control
policy reauthorization act of 1998.
Subtitle D--Synthetic Abuse and Labeling of Toxic Substances
Sec. 3401. Short title.
Sec. 3402. Controlled substance analogues.
Subtitle E--Opioid Quota Reform
Sec. 3501. Short title.
Sec. 3502. Strengthening considerations for DEA opioid quotas.
Subtitle F--Preventing Drug Diversion
Sec. 3601. Short title.
Sec. 3602. Improvements to prevent drug diversion.
Subtitle G--Sense of Congress
Sec. 3701. Sense of Congress.
TITLE IV--COMMERCE
Subtitle A--Fighting Opioid Abuse in Transportation
Sec. 4101. Short title.
Sec. 4102. Rail mechanical employee controlled substances and alcohol
testing.
Sec. 4103. Rail yardmaster controlled substances and alcohol testing.
Sec. 4104. Department of Transportation public drug and alcohol testing
database.
Sec. 4105. GAO report on Department of Transportation's collection and
use of drug and alcohol testing data.
Sec. 4106. Transportation Workplace Drug and Alcohol Testing Program;
addition of fentanyl.
Sec. 4107. Status reports on hair testing guidelines.
Sec. 4108. Mandatory Guidelines for Federal Workplace Drug Testing
Programs Using Oral Fluid.
Sec. 4109. Electronic recordkeeping.
Sec. 4110. Status reports on Commercial Driver's License Drug and
Alcohol Clearinghouse.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
Sec. 4201. Short title.
Sec. 4202. Definitions.
Sec. 4203. False or misleading representations with respect to opioid
treatment programs and products.
TITLE I--OPIOID CRISIS RESPONSE ACT
SEC. 1001. DEFINITIONS.
In this title--
(1) the terms ``Indian Tribe'' and ``tribal organization''
have the meanings given the terms ``Indian tribe'' and
``tribal organization'' in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 5304);
and
(2) the term ``Secretary'' means the Secretary of Health
and Human Services, unless otherwise specified.
Subtitle A--Reauthorization of Cures Funding
SEC. 1101. STATE RESPONSE TO THE OPIOID ABUSE CRISIS.
(a) In General.--Section 1003 of the 21st Century Cures Act
(Public Law 114-255) is amended--
(1) in subsection (a)--
(A) by striking ``the authorization of appropriations under
subsection (b) to carry out the grant program described in
subsection (c)'' and inserting ``subsection (h) to carry out
the grant program described in subsection (b)''; and
(B) by inserting ``and Indian Tribes'' after ``States'';
(2) by striking subsection (b);
(3) by redesignating subsections (c) through (e) as
subsections (b) through (d), respectively;
(4) by redesignating subsection (f) as subsection (j);
(5) in subsection (b), as so redesignated--
(A) in paragraph (1)--
(i) in the paragraph heading, by inserting ``and indian
tribe'' after ``State'';
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(ii) by striking ``States for the purpose of addressing the
opioid abuse crisis within such States'' and inserting
``States and Indian Tribes for the purpose of addressing the
opioid abuse crisis within such States and Indian Tribes'';
(iii) by inserting ``or Indian Tribes'' after ``preference
to States''; and
(iv) by inserting before the period of the second sentence
``or other Indian Tribes, as applicable'';
(B) in paragraph (2)--
(i) in the matter preceding subparagraph (A), by striking
``to a State'';
(ii) in subparagraph (A), by striking ``State'';
(iii) in subparagraph (C), by inserting ``preventing
diversion of controlled substances,'' after ``treatment
programs,''; and
(iv) in subparagraph (E), by striking ``as the State
determines appropriate, related to addressing the opioid
abuse crisis within the State'' and inserting ``as the State
or Indian Tribe determines appropriate, related to addressing
the opioid abuse crisis within the State, including directing
resources in accordance with local needs related to substance
use disorders'';
(6) in subsection (c), as so redesignated, by striking
``subsection (c)'' and inserting ``subsection (b)'';
(7) in subsection (d), as so redesignated--
(A) in the matter preceding paragraph (1), by striking
``the authorization of appropriations under subsection (b)''
and inserting ``subsection (h)''; and
(B) in paragraph (1), by striking ``subsection (c)'' and
inserting ``subsection (b)''; and
(8) by inserting after subsection (d), as so redesignated,
the following:
``(e) Indian Tribes.--
``(1) Definition.--For purposes of this section, the term
`Indian Tribe' has the meaning given the term `Indian tribe'
in section 4 of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 5304).
``(2) Appropriate mechanisms.--The Secretary, in
consultation with Indian Tribes, shall identify and establish
appropriate mechanisms for Tribes to demonstrate or report
the information as required under subsections (b), (c), and
(d).
``(f) Report to Congress.--Not later than 1 year after the
date on which amounts are first awarded after the date of
enactment of the Opioid Crisis Response Act of 2018, pursuant
to subsection (b), and annually thereafter, the Secretary
shall submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report summarizing
the information provided to the Secretary in reports made
pursuant to subsection (c), including the purposes for which
grant funds are awarded under this section and the activities
of such grant recipients.
``(g) Technical Assistance.--The Secretary, including
through the Tribal Training and Technical Assistance Center
of the Substance Abuse and Mental Health Services
Administration, shall provide State agencies and Indian
Tribes, as applicable, with technical assistance concerning
grant application and submission procedures under this
section, award management activities, and enhancing outreach
and direct support to rural and underserved communities and
providers in addressing the opioid crisis.
``(h) Authorization of Appropriations.--For purposes of
carrying out the grant program under subsection (b), there is
authorized to be appropriated $500,000,000 for each of fiscal
years 2019 through 2021, to remain available until expended.
``(i) Set Aside.--Of the amounts made available for each
fiscal year to award grants under subsection (b) for a fiscal
year, 5 percent of such amount for such fiscal year shall be
made available to Indian Tribes, and up to 15 percent of such
amount for such fiscal year may be set aside for States with
the highest age-adjusted rate of drug overdose death based on
the ordinal ranking of States according to the Director of
the Centers for Disease Control and Prevention.''.
(b) Conforming Amendment.--Section 1004(c) of the 21st
Century Cures Act (Public Law 114-255) is amended by striking
``, the FDA Innovation Account, or the Account For the State
Response to the Opioid Abuse Crisis'' and inserting ``or the
FDA Innovation Account''.
Subtitle B--Research and Innovation
SEC. 1201. ADVANCING CUTTING-EDGE RESEARCH.
Section 402(n)(1) of the Public Health Service Act (42
U.S.C. 282(n)(1)) is amended--
(1) in subparagraph (A), by striking ``or'';
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(C) high impact cutting-edge research that fosters
scientific creativity and increases fundamental biological
understanding leading to the prevention, diagnosis, or
treatment of diseases and disorders, or research urgently
required to respond to a public health threat.''.
SEC. 1202. PAIN RESEARCH.
Section 409J(b) of the Public Health Service Act (42 U.S.C.
284q(b)) is amended--
(1) in paragraph (5)--
(A) in subparagraph (A), by striking ``and treatment of
pain and diseases and disorders associated with pain'' and
inserting ``treatment, and management of pain and diseases
and disorders associated with pain, including information on
best practices for utilization of non-pharmacologic
treatments, non-addictive medical products, and other drugs
or devices approved or cleared by the Food and Drug
Administration'';
(B) in subparagraph (B), by striking ``on the symptoms and
causes of pain;'' and inserting the following: ``on--
``(i) the symptoms and causes of pain, including the
identification of relevant biomarkers and screening models
and the epidemiology of acute and chronic pain;
``(ii) the diagnosis, prevention, treatment, and management
of acute or chronic pain, including with respect to non-
pharmacologic treatments, non-addictive medical products, and
other drugs or devices approved or cleared by the Food and
Drug Administration; and
``(iii) risk factors for, and early warning signs of,
substance use disorders; and''; and
(C) by striking subparagraphs (C) through (E) and inserting
the following:
``(C) make recommendations to the Director of NIH--
``(i) to ensure that the activities of the National
Institutes of Health and other Federal agencies are free of
unnecessary duplication of effort;
``(ii) on how best to disseminate information on pain care
and epidemiological data related to acute and chronic pain;
and
``(iii) on how to expand partnerships between public
entities and private entities to expand collaborative, cross-
cutting research.'';
(2) by redesignating paragraph (6) as paragraph (7); and
(3) by inserting after paragraph (5) the following:
``(6) Report.--The Director of NIH shall ensure that
recommendations and actions taken by the Director with
respect to the topics discussed at the meetings described in
paragraph (4) are included in appropriate reports to
Congress.''.
SEC. 1203. REPORT ON SYNTHETIC DRUG USE.
(a) In General.--Not later than 3 years after the date of
the enactment of this Act, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report on the health effects of new
psychoactive substances, including synthetic drugs, by
adolescents and young adults.
(b) New Psychoactive Substance Defined.--For purposes of
subsection (a), the term ``new psychoactive substance'' means
a controlled substance analogue (as defined in section
102(32) of the Controlled Substances Act (21 U.S.C.
802(32))).
Subtitle C--Medical Products and Controlled Substances Safety
SEC. 1301. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN
PRODUCTS.
(a) Public Meetings.--Not later than one year after the
date of enactment of this Act, the Secretary, acting through
the Commissioner of Food and Drugs, shall hold not less than
one public meeting to address the challenges and barriers of
developing non-addictive medical products intended to treat
pain or addiction, which may include--
(1) the manner by which the Secretary may incorporate the
risks of misuse and abuse of a controlled substance (as
defined in section 102 of the Controlled Substances Act (21
U.S.C. 802) into the risk benefit assessments under
subsections (d) and (e) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of
such Act (21 U.S.C. 360(k)), or section 515(c) of such Act
(21 U.S.C. 360e(c)), as applicable;
(2) the application of novel clinical trial designs
(consistent with section 3021 of the 21st Century Cures Act
(Public Law 114-255)), use of real world evidence (consistent
with section 505F of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355g)), and use of patient experience data
(consistent with section 569C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8c)) for the development of
non-addictive medical products intended to treat pain or
addiction;
(3) the evidentiary standards and the development of opioid
sparing data for inclusion in the labeling of medical
products; and
(4) the application of eligibility criteria under sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) for non-addictive medical products
intended to treat pain or addiction.
(b) Guidance.--Not less than one year after the public
meetings are conducted under subsection (a) the Secretary
shall issue one or more final guidance documents, or update
existing guidance documents, to help address challenges to
developing non-addictive medical products to treat pain or
addiction. Such guidance documents shall include information
regarding--
(1) how the Food and Drug Administration may apply sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) to non-addictive medical products
intended to treat pain or addiction, including the
circumstances under which the Secretary--
(A) may apply the eligibility criteria under such sections
506 and 515B to non-addictive medical products intended to
treat pain or addiction;
(B) considers the risk of addiction of controlled
substances approved to treat pain when establishing unmet
medical need; and
(C) considers pain, pain control, or pain management in
assessing whether a disease or condition is a serious or
life-threatening disease or condition;
(2) the methods by which sponsors may evaluate acute and
chronic pain, endpoints for non-addictive medical products
intended
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to treat pain, the manner in which endpoints and evaluations
of efficacy will be applied across and within review
divisions, taking into consideration the etiology of the
underlying disease, and the manner in which sponsors may use
surrogate endpoints, intermediate endpoints, and real world
evidence;
(3) the manner in which the Food and Drug Administration
will assess evidence to support the inclusion of opioid
sparing data in the labeling of non-addictive medical
products intended to treat pain, including--
(A) data collection methodologies, including the use of
novel clinical trial designs (consistent with section 3021 of
the 21st Century Cures Act (Public Law 114-255)) and real
world evidence (consistent with section 505F of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), as
appropriate, to support product labeling;
(B) ethical considerations of exposing subjects to
controlled substances in clinical trials to develop opioid
sparing data and considerations on data collection methods
that reduce harm, which may include the reduction of opioid
use as a clinical benefit;
(C) endpoints, including primary, secondary, and surrogate
endpoints, to evaluate the reduction of opioid use;
(D) best practices for communication between sponsors and
the agency on the development of data collection methods,
including the initiation of data collection; and
(E) the appropriate format in which to submit such data
results to the Secretary; and
(4) the circumstances under which the Food and Drug
Administration considers misuse and abuse of a controlled
substance (as defined in section 102 of the Controlled
Substances Act (21 U.S.C. 802) in making the risk benefit
assessment under paragraphs (2) and (4) of subsection (d) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) and in finding that a drug is unsafe under
paragraph (1) or (2) of subsection (e) of such section.
(c) Definitions.--In this section--
(1) the term ``medical product'' means a drug (as defined
in section 201(g)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(g)(1))), biological product (as defined in
section 351(i) of the Public Health Service Act (42 U.S.C.
262(i))), or device (as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and
(2) the term ``opioid sparing'' means reducing, replacing,
or avoiding the use of opioids or other controlled
substances.
SEC. 1302. CLARIFYING FDA PACKAGING AUTHORITIES.
(a) Additional Potential Elements of Strategy.--Section
505-1(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(e)) is amended by adding at the end the
following:
``(4) Packaging and disposal.--The Secretary may require a
risk evaluation mitigation strategy for a drug for which
there is a serious risk of an adverse drug experience
described in subparagraph (B) or (C) of subsection (b)(1),
taking into consideration the factors described in
subparagraphs (C) and (D) of subsection (f)(2) and in
consultation with other relevant Federal agencies with
authorities over drug packaging, which may include requiring
that--
``(A) the drug be made available for dispensing to certain
patients in unit dose packaging, packaging that provides a
set duration, or another packaging system that the Secretary
determines may mitigate such serious risk; or
``(B) the drug be dispensed to certain patients with a safe
disposal packaging or safe disposal system for purposes of
rendering drugs non-retrievable (as defined in section
1300.05 of title 21, Code of Federal Regulations (or any
successor regulation)) if the Secretary has determines that
such safe disposal packaging or system may mitigate such
serious risk and exists in sufficient quantities.''.
(b) Assuring Access and Minimizing Burden.--Section 505-
1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1(f)(2)(C)) is amended--
(1) in clause (i) by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) patients with functional needs; and''.
(c) Application to Abbreviated New Drug Applications.--
Section 505-1(i) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355-1(i)) is amended--
(1) in paragraph (1)--
(A) by redesignating subparagraph (B) as subparagraph (C);
and
(B) inserting after subparagraph (A) the following:
``(B) A packaging or disposal requirement, if required
under subsection (e)(4) for the applicable listed drug.'';
and
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``and'' at the end;
(B) by redesignating subparagraph (B) as subparagraph (C);
and
(C) by inserting after subparagraph (A) the following:
``(B) shall permit packaging systems and safe disposal
packaging or safe disposal systems that are different from
those required for the applicable listed drug under
subsection (e)(4); and''.
SEC. 1303. STRENGTHENING FDA AND CBP COORDINATION AND
CAPACITY.
(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, shall coordinate with the
Secretary of Homeland Security to carry out activities
related to customs and border protection and response to
illegal controlled substances and drug imports, including at
sites of import (such as international mail facilities). Such
Secretaries may carry out such activities through a
memorandum of understanding between the Food and Drug
Administration and the U.S. Customs and Border Protection.
(b) FDA Import Facilities and Inspection Capacity.--
(1) In general.--In carrying out this section, the
Secretary shall, in collaboration with the Secretary of
Homeland Security and the Postmaster General of the United
States Postal Service, provide that import facilities in
which the Food and Drug Administration operates or carries
out activities related to drug imports within the
international mail facilities include--
(A) facility upgrades and improved capacity in order to
increase and improve inspection and detection capabilities,
which may include, as the Secretary determines appropriate--
(i) improvements to facilities, such as upgrades or
renovations, and support for the maintenance of existing
import facilities and sites to improve coordination between
Federal agencies;
(ii) the construction of, or upgrades to, laboratory
capacity for purposes of detection and testing of imported
goods;
(iii) upgrades to the security of import facilities; and
(iv) innovative technology and equipment to facilitate
improved and near-real-time information sharing between the
Food and Drug Administration, the Department of Homeland
Security, and the United States Postal Service; and
(B) innovative technology, including controlled substance
detection and testing equipment and other applicable
technology, in order to collaborate with the U.S. Customs and
Border Protection to share near-real-time information,
including information about test results, as appropriate.
(2) Innovative technology.--Any technology used in
accordance with paragraph (1)(B) shall be interoperable with
technology used by other relevant Federal agencies, including
the U.S. Customs and Border Protection, as the Secretary
determines appropriate.
(c) Report.--Not later than 6 months after the date of
enactment of this Act, the Secretary, in consultation with
the Secretary of Homeland Security and the Postmaster General
of the United States Postal Service, shall report to the
relevant committees of Congress on the implementation of this
section, including a summary of progress made towards near-
real-time information sharing and the interoperability of
such technologies.
(d) Authorization of Appropriations.--Out of amounts
otherwise available to the Secretary, the Secretary may
allocate such sums as may be necessary for purposes of
carrying out this section.
SEC. 1304. CLARIFYING FDA POST-MARKET AUTHORITIES.
Section 505-1(b)(1)(E) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1(b)(1)(E)) is amended by
striking ``of the drug'' and inserting ``of the drug, which
may include reduced effectiveness under the conditions of use
prescribed in the labeling of such drug, but which may not
include reduced effectiveness that is in accordance with such
labeling''.
SEC. 1305. RESTRICTING ENTRANCE OF ILLICIT DRUGS.
(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, upon discovering or
receiving, in a package being offered for import, a
controlled substance that is offered for import in violation
of any requirement of the Controlled Substances Act (21
U.S.C. 801 et seq.), the Controlled Substances Import and
Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), or any other
applicable law, shall transfer such package to the U.S.
Customs and Border Protection. If the Secretary identifies
additional packages that appear to be the same as such
package containing a controlled substance, such additional
packages may also be transferred to U.S. Customs and Border
Protection. The U.S. Customs and Border Protection shall
receive such packages consistent with the requirements of the
Controlled Substances Act (21 U.S.C. 801 et seq.).
(b) Debarment, Temporary Denial of Approval, and
Suspension.--
(1) In general.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by inserting
``or (3)'' after ``paragraph (2)'';
(ii) in subparagraph (A), by striking the comma at the end
and inserting a semicolon;
(iii) in subparagraph (B), by striking ``, or'' and
inserting a semicolon;
(iv) in subparagraph (C), by striking the period and
inserting ``; or''; and
(v) by adding at the end the following:
``(D) a person from importing or offering for import into
the United States a drug.''; and
(B) in paragraph (3)--
(i) in the heading, by striking ``Food'';
(ii) in subparagraph (A), by striking ``; or'' and
inserting a semicolon;
(iii) in subparagraph (B), by striking the period and
inserting a semicolon; and
(iv) by adding at the end the following:
``(C) the person has been convicted of a felony for conduct
relating to the importation
[[Page S6067]]
into the United States of any drug or controlled substance
(as defined in section 102 of the Controlled Substances Act);
``(D) the person has engaged in a pattern of importing or
offering for import--
``(i) controlled substances that are prohibited from
importation under section 401(m) of the Tariff Act of 1930
(19 U.S.C. 1401(m)); or
``(ii) adulterated or misbranded drugs that are--
``(I) not designated in an authorized electronic data
interchange system as a product that is regulated by the
Secretary; or
``(II) knowingly or intentionally falsely designated in an
authorized electronic data interchange system as a product
that is regulated by the Secretary.''.
(2) Prohibited act.--Section 301(cc) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended by
inserting ``or a drug'' after ``food''.
(c) Imports and Exports.--Section 801(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended--
(1) by striking the second sentence;
(2) by striking ``If it appears'' and inserting ``Subject
to subsection (b), if it appears'';
(3) by striking ``regarding such article, then such article
shall be refused'' and inserting the following: ``regarding
such article, or (5) such article is being imported or
offered for import in violation of section 301(cc), then any
such article described in any of clauses (1) through (5) may
be refused admission. If it appears from the examination of
such samples or otherwise that the article is a counterfeit
drug, such article shall be refused admission.'';
(4) by striking ``this Act, then such article shall be
refused admission'' and inserting ``this Act, then such
article may be refused admission''; and
(5) by striking ``Clause (2) of the third sentence'' and
all that follows through the period at the end and inserting
the following: ``Neither clause (2) nor clause (5) of the
second sentence of this subsection shall be construed to
prohibit the admission of narcotic drugs, the importation of
which is permitted under the Controlled Substances Import and
Export Act.''.
(d) Certain Illicit Articles.--Section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by
adding at the end the following--
``(t) Illicit Articles Containing Active Pharmaceutical
Ingredients.--
``(1) In general.--For purposes of this section, an article
that is being imported or offered for import into the United
States may be treated by the Secretary as a drug if the
article--
``(A) is not--
``(i) accompanied by an electronic import entry for such
article submitted using an authorized electronic data
interchange system; and
``(ii) designated in such a system as an article regulated
by the Secretary (which may include regulation as a drug, a
device, or a dietary supplement; and
``(B) is an ingredient that presents significant public
health concern and is, or contains--
``(i) an active ingredient in a drug--
``(I) that is approved under section 505 or licensed under
section 351 of the Public Health Service Act; or
``(II) for which--
``(aa) an investigational use exemption is in effect under
section 505(i) of this Act or section 351(a) of the Public
Health Service Act; and
``(bb) a substantial clinical investigation has been
instituted, and such investigation has been made public; or
``(ii) a substance that has a chemical structure that is
substantially similar to the chemical structure of an active
ingredient in a drug or biological product described in
subclause (I) or (II) of clause (i).
``(2) Effect.--This subsection shall not be construed to
bear upon any determination of whether an article is a drug
within the meaning of section 201(g), other than for the
purposes described in paragraph (1).''.
SEC. 1306. FIRST RESPONDER TRAINING.
Section 546 of the Public Health Service Act (42 U.S.C.
290ee-1) is amended--
(1) in subsection (c)--
(A) in paragraph (2), by striking ``and'' at the end;
(B) in paragraph (3), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(4) train and provide resources for first responders and
members of other key community sectors on safety around
fentanyl, carfentanil, and other dangerous licit and illicit
drugs to protect themselves from exposure to such drugs and
respond appropriately when exposure occurs.'';
(2) in subsection (d), by striking ``and mechanisms for
referral to appropriate treatment for an entity receiving a
grant under this section'' and inserting ``mechanisms for
referral to appropriate treatment, and safety around
fentanyl, carfentanil, and other dangerous licit and illicit
drugs'';
(3) in subsection (f)--
(A) in paragraph (3), by striking ``and'' at the end;
(B) in paragraph (4), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(5) the number of first responders and members of other
key community sectors trained on safety around fentanyl,
carfentanil, and other dangerous licit and illicit drugs.'';
(4) by redesignating subsection (g) as subsection (h);
(5) by inserting after subsection (f) the following:
``(g) Other Key Community Sectors.--In this section, the
term `other key community sectors' includes substance abuse
treatment providers, emergency medical services agencies,
agencies and organizations working with prison and jail
populations and offender reentry programs, health care
providers, harm reduction groups, pharmacies, community
health centers, tribal health facilities, and mental health
providers.''; and
(6) in subsection (h), as so redesignated, by striking
``$12,000,000 for each of fiscal years 2017 through 2021''
and inserting ``$36,000,000 for each of fiscal years 2019
through 2023''.
SEC. 1307. DISPOSAL OF CONTROLLED SUBSTANCES OF HOSPICE
PATIENTS.
(a) In General.--Section 302(g) of the Controlled
Substances Act (21 U.S.C. 822(g)) is amended by adding at the
end the following:
``(5)(A) An employee of a qualified hospice program acting
within the scope of employment may handle, in the place of
residence of a hospice patient, any controlled substance that
was lawfully dispensed to the hospice patient, for the
purpose of assisting in the disposal of the controlled
substance--
``(i) after the hospice patient's death;
``(ii) if the controlled substance is expired; or
``(iii) if--
``(I) the employee is--
``(aa) the physician of the hospice patient; and
``(bb) registered under section 303(f); and
``(II) the hospice patient no longer requires the
controlled substance because the plan of care of the hospice
patient has been modified.
``(B) In this paragraph:
``(i) The term `employee of a qualified hospice program'
means a physician, physician assistant, registered nurse, or
nurse practitioner who--
``(I) is employed by, or is acting pursuant to arrangements
made with, a qualified hospice program; and
``(II) is licensed or certified to perform such employment,
or such activities arranged by the qualified hospice program,
in accordance with applicable State law.
``(ii) The terms `hospice care' and `hospice program' have
the meanings given those terms in section 1861(dd) of the
Social Security Act (42 U.S.C. 1395x(dd)).
``(iii) The term `hospice patient' means an individual
receiving hospice care.
``(iv) The term `qualified hospice program' means a hospice
program that--
``(I) has written policies and procedures for employees of
the hospice program to use when assisting in the disposal of
the controlled substances of a hospice patient in a
circumstance described in clause (i), (ii), or (iii) of
subparagraph (A);
``(II) at the time when the controlled substances are first
ordered--
``(aa) provides a copy of the written policies and
procedures to the hospice patient or hospice patient
representative and the family of the hospice patient;
``(bb) discusses the policies and procedures with the
hospice patient or hospice patient's representative and the
hospice patient's family in a language and manner that such
individuals understand to ensure that such individuals are
informed regarding the safe disposal of controlled
substances; and
``(cc) documents in the clinical record of the hospice
patient that the written policies and procedures were
provided and discussed with the hospice patient or hospice
patient's representative; and
``(III) at the time when an employee of the hospice program
assists in the disposal of controlled substances of a hospice
patient, documents in the clinical record of the hospice
patient a list of all controlled substances disposed of.
``(C) The Attorney General may, by regulation, include
additional types of licensed medical professionals in the
definition of the term `employee of a qualified hospice
program' under subparagraph (B).''.
(b) No Registration Required.--Section 302(c) of the
Controlled Substances Act (21 U.S.C. 822(c)) is amended by
adding at the end the following:
``(4) An employee of a qualified hospice program for the
purpose of assisting in the disposal of a controlled
substance in accordance with subsection (g)(5), except as
provided in subparagraph (A)(iii) of that subsection.''.
(c) Guidance.--The Attorney General may issue guidance to
qualified hospice programs to assist the programs in
satisfying the requirements under paragraph (5) of section
302(g) of the Controlled Substances Act (21 U.S.C. 822(g)),
as added by subsection (a).
(d) State and Local Authority.--Nothing in this section or
the amendments made by this section shall be construed to
prevent a State or local government from imposing additional
controls or restrictions relating to the regulation of the
disposal of controlled substances in hospice care or hospice
programs.
SEC. 1308. GAO STUDY AND REPORT ON HOSPICE SAFE DRUG
MANAGEMENT.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study on the requirements
applicable to and challenges of hospice programs with regard
to the management and disposal of
[[Page S6068]]
controlled substances in the home of an individual.
(2) Contents.--In conducting the study under paragraph (1),
the Comptroller General shall include--
(A) an overview of challenges encountered by hospice
programs regarding the disposal of controlled substances,
such as opioids, in a home setting, including any key changes
in policies, procedures, or best practices for the disposal
of controlled substances over time; and
(B) a description of Federal requirements, including
requirements under the Medicare program, for hospice programs
regarding the disposal of controlled substances in a home
setting, and oversight of compliance with those requirements.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General shall submit
to Congress a report containing the results of the study
conducted under subsection (a), together with
recommendations, if any, for such legislation and
administrative action as the Comptroller General determines
appropriate.
SEC. 1309. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY
TO BE ADMINISTERED BY INJECTION OR
IMPLANTATION.
(a) In General.--The Controlled Substances Act is amended
by inserting after section 309 (21 U.S.C. 829) the following:
``delivery of a controlled substance by a pharmacy to an administering
practitioner
``Sec. 309A. (a) In General.--Notwithstanding section
102(10), a pharmacy may deliver a controlled substance to a
practitioner in accordance with a prescription that meets the
requirements of this title and the regulations issued by the
Attorney General under this title, for the purpose of
administering the controlled substance by the practitioner
if--
``(1) the controlled substance is delivered by the pharmacy
to the prescribing practitioner or the practitioner
administering the controlled substance, as applicable, at the
location listed on the practitioner's certificate of
registration issued under this title;
``(2) in the case of administering of the controlled
substance for the purpose of maintenance or detoxification
treatment under section 303(g)(2)--
``(A) the practitioner who issued the prescription is a
qualifying practitioner authorized under, and acting within
the scope of that section; and
``(B) the controlled substance is to be administered by
injection or implantation;
``(3) the pharmacy and the practitioner are authorized to
conduct the activities specified in this section under the
law of the State in which such activities take place;
``(4) the prescription is not issued to supply any
practitioner with a stock of controlled substances for the
purpose of general dispensing to patients;
``(5) except as provided in subsection (b), the controlled
substance is to be administered only to the patient named on
the prescription not later than 14 days after the date of
receipt of the controlled substance by the practitioner; and
``(6) notwithstanding any exceptions under section 307, the
prescribing practitioner, and the practitioner administering
the controlled substance, as applicable, maintain complete
and accurate records of all controlled substances delivered,
received, administered, or otherwise disposed of under this
section, including the persons to whom controlled substances
were delivered and such other information as may be required
by regulations of the Attorney General.
``(b) Modification of Number of Days Before Which
Controlled Substance Shall Be Administered.--
``(1) Initial 2-year period.--During the 2-year period
beginning on the date of enactment of this section, the
Attorney General, in coordination with the Secretary, may
reduce the number of days described in subsection (a)(5) if
the Attorney General determines that such reduction will--
``(A) reduce the risk of diversion; or
``(B) protect the public health.
``(2) Modifications after submission of report.--After the
date on which the report described in subsection (c) is
submitted, the Attorney General, in coordination with the
Secretary, may modify the number of days described in
subsection (a)(5).
``(3) Minimum number of days.--Any modification under this
subsection shall be for a period of not less than 7 days.''.
(b) Study and Report.--Not later than 2 years after the
date of enactment of this section, the Comptroller General of
the United States shall conduct a study and submit to
Congress a report on access to and potential diversion of
controlled substances administered by injection or
implantation.
(c) Technical and Conforming Amendment.--The table of
contents for the Comprehensive Drug Abuse Prevention and
Control Act of 1970 is amended by inserting after the item
relating to section 309 the following:
``Sec. 309A. Delivery of a controlled substance by a pharmacy to an
administering practitioner.''.
Subtitle D--Treatment and Recovery
SEC. 1401. COMPREHENSIVE OPIOID RECOVERY CENTERS.
(a) In General.--The Secretary shall award grants on a
competitive basis to eligible entities to establish or
operate a comprehensive opioid recovery center (referred to
in this section as a ``Center''). A Center may be a single
entity or an integrated delivery network.
(b) Grant Period.--
(1) In general.--A grant awarded under subsection (a) shall
be for a period not more than 5 years.
(2) Renewal.--A grant awarded under subsection (a) may be
renewed, on a competitive basis, for additional periods of
time, as determined by the Secretary. In determining whether
to renew a grant under this paragraph, the Secretary shall
consider the data submitted under subsection (h).
(c) Minimum Number of Grants.--The Secretary shall allocate
the amounts made available under subsection (j) such that not
fewer than 10 grants may be awarded. Not more than one grant
shall be made to entities in a single State for any one
period.
(d) Application.--
(1) Eligible entity.--An entity is eligible for a grant
under this section if the entity offers treatment and other
services for individuals with a substance use disorder.
(2) Submission of application.--In order to be eligible for
a grant under subsection (a), an entity shall submit an
application to the Secretary at such time and in such manner
as the Secretary may require. Such application shall
include--
(A) evidence that such entity carries out, or is capable of
coordinating with other entities to carry out, the activities
described in subsection (g); and
(B) such other information as the Secretary may require.
(e) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to eligible entities located in
a State or Indian Tribe with an age-adjusted rate of drug
overdose deaths that is above the national overdose mortality
rate, as determined by the Director of the Centers for
Disease Control and Prevention.
(f) Preference.--In awarding grants under subsection (a),
the Secretary may give preference to eligible entities
utilizing technology-enabled collaborative learning and
capacity building models, including such models as defined in
section 2 of the Expanding Capacity for Health Outcomes Act
(Public Law 114-270; 130 Stat. 1395), to conduct the
activities described in this section.
(g) Center Activities.--Each Center shall, at a minimum,
carry out the following activities directly, through
referral, or through contractual arrangements, which may
include carrying out such activities through technology-
enabled collaborative learning and capacity building models
described in subsection (f):
(1) Treatment and recovery services.--Each Center shall--
(A) ensure that intake and evaluations meet the
individualized clinical needs of patients, including by
offering assessments for services and care recommendations
through independent, evidence-based verification processes
for reviewing patient placement in treatment settings;
(B) provide the full continuum of treatment services,
including--
(i) all drugs approved by the Food and Drug Administration
to treat substance use disorders, pursuant to Federal and
State law;
(ii) medically supervised withdrawal management that
includes patient evaluation, stabilization, and readiness for
and entry into treatment;
(iii) counseling provided by a program counselor or other
certified professional who is licensed and qualified by
education, training, or experience to assess the
psychological and sociological background of patients, to
contribute to the appropriate treatment plan for the patient,
and to monitor patient progress;
(iv) treatment, as appropriate, for patients with co-
occurring substance use and mental disorders;
(v) testing, as appropriate, for infections commonly
associated with illicit drug use;
(vi) residential rehabilitation, and outpatient and
intensive outpatient programs;
(vii) recovery housing;
(viii) community-based and peer recovery support services;
(ix) job training, job placement assistance, and continuing
education assistance to support reintegration into the
workforce; and
(x) other best practices to provide the full continuum of
treatment and services, as determined by the Secretary;
(C) ensure that all programs covered by the Center include
medication-assisted treatment, as appropriate, and do not
exclude individuals receiving medication-assisted treatment
from any service;
(D) periodically conduct patient assessments to support
sustained and clinically significant recovery, as defined by
the Assistant Secretary for Mental Health and Substance Use;
(E) administer an onsite pharmacy and provide toxicology
services, for purposes of carrying out this section; and
(F) operate a secure, confidential, and interoperable
electronic health information system.
(2) Outreach.--Each Center shall carry out outreach
activities to publicize the services offered through the
Centers, which may include--
(A) training and supervising outreach staff, as
appropriate, to work with State and local health departments,
health care providers, the Indian Health Service, State and
local educational agencies, schools funded by the Indian
Bureau of Education, institutions of higher education, State
and local workforce
[[Page S6069]]
development boards, State and local community action
agencies, public safety officials, first responders, Indian
Tribes, child welfare agencies, as appropriate, and other
community partners and the public, including patients, to
identify and respond to community needs;
(B) ensuring that the entities described in subparagraph
(A) are aware of the services of the Center; and
(C) disseminating and making publicly available, including
through the internet, evidence-based resources that educate
professionals and the public on opioid use disorder and other
substance use disorders, including co-occurring substance use
and mental disorders.
(h) Data Reporting and Program Oversight.--With respect to
a grant awarded under subsection (a), not later than 90 days
after the end of the first year of the grant period, and
annually thereafter for the duration of the grant period
(including the duration of any renewal period for such
grant), the entity shall submit data, as appropriate, to the
Secretary regarding--
(1) the programs and activities funded by the grant;
(2) health outcomes of the population of individuals with a
substance use disorder who received services from the Center,
evaluated by an independent program evaluator through the use
of outcomes measures, as determined by the Secretary;
(3) the retention rate of program participants; and
(4) any other information that the Secretary may require
for the purpose of ensuring that the Center is complying with
all the requirements of the grant, including providing the
full continuum of services described in subsection (g)(1)(B).
(i) Privacy.--The provisions of this section, including
with respect to data reporting and program oversight, shall
be subject to all applicable Federal and State privacy laws.
(j) Authorization of Appropriations.--There is authorized
to be appropriated $10,000,000 for each of fiscal years 2019
through 2023 for purposes of carrying out this section.
(k) Reports to Congress.--
(1) Preliminary report.--Not later than 3 years after the
date of the enactment of this Act, the Secretary shall submit
to Congress a preliminary report that analyzes data submitted
under subsection (h).
(2) Final report.--Not later than 2 years after submitting
the preliminary report required under paragraph (1), the
Secretary shall submit to Congress a final report that
includes--
(A) an evaluation of the effectiveness of the comprehensive
services provided by the Centers established or operated
pursuant to this section with respect to health outcomes of
the population of individuals with substance use disorder who
receive services from the Center, which shall include an
evaluation of the effectiveness of services for treatment and
recovery support and to reduce relapse, recidivism, and
overdose; and
(B) recommendations, as appropriate, regarding ways to
improve Federal programs related to substance use disorders,
which may include dissemination of best practices for the
treatment of substance use disorders to health care
professionals.
SEC. 1402. PROGRAM TO SUPPORT COORDINATION AND CONTINUATION
OF CARE FOR DRUG OVERDOSE PATIENTS.
(a) In General.--The Secretary shall identify or facilitate
the development of best practices for--
(1) emergency treatment of known or suspected drug
overdose;
(2) the use of recovery coaches, as appropriate, to
encourage individuals who experience a non-fatal overdose to
seek treatment for substance use disorder and to support
coordination and continuation of care;
(3) coordination and continuation of care and treatment,
including, as appropriate, through referrals, of individuals
after an opioid overdose; and
(4) the provision of overdose reversal medication, as
appropriate.
(b) Grant Establishment and Participation.--
(1) In general.--The Secretary shall award grants on a
competitive basis to eligible entities to support
implementation of voluntary programs for care and treatment
of individuals after an opioid overdose, as appropriate,
which may include implementation of the best practices
described in subsection (a).
(2) Eligible entity.--In this section, the term ``eligible
entity'' means--
(A) a State alcohol or drug agency;
(B) an Indian Tribe or tribal organization; or
(C) an entity that offers treatment or other services for
individuals in response to, or following, drug overdoses or a
drug overdose, in consultation with a State alcohol and drug
agency.
(3) Application.--An eligible entity desiring a grant under
this section shall submit an application to the Secretary, at
such time and in such manner as the Secretary may require,
that includes--
(A) evidence that such eligible entity carries out, or is
capable of contracting and coordinating with other community
entities to carry out, the activities described in paragraph
(4);
(B) evidence that such eligible entity will work with a
recovery community organization to recruit, train, hire,
mentor, and supervise recovery coaches and fulfill the
requirements described in paragraph (4)(A); and
(C) such additional information as the Secretary may
require.
(4) Use of grant funds.--An eligible entity awarded a grant
under this section shall use such grant funds to--
(A) hire or utilize recovery coaches to help support
recovery, including by--
(i) connecting patients to a continuum of care services,
such as--
(I) treatment and recovery support programs;
(II) programs that provide non-clinical recovery support
services;
(III) peer support networks;
(IV) recovery community organizations;
(V) health care providers, including physicians and other
providers of behavioral health and primary care;
(VI) education and training providers;
(VII) employers;
(VIII) housing services; and
(IX) child welfare agencies;
(ii) providing education on overdose prevention and
overdose reversal to patients and families, as appropriate;
(iii) providing follow-up services for patients after an
overdose to ensure continued recovery and connection to
support services;
(iv) collecting and evaluating outcome data for patients
receiving recovery coaching services; and
(v) providing other services the Secretary determines
necessary to help ensure continued connection with recovery
support services, including culturally appropriate services,
as applicable;
(B) establish policies and procedures, pursuant to Federal
and State law, that address the provision of overdose
reversal medication, the administration of all drugs approved
by the Food and Drug Administration to treat substance use
disorder, and subsequent continuation of, or referral to,
evidence-based treatment for patients with a substance use
disorder who have experienced a non-fatal drug overdose, in
order to support long-term treatment, prevent relapse, and
reduce recidivism and future overdose; and
(C) establish integrated models of care for individuals who
have experienced a non-fatal drug overdose which may include
patient assessment, follow up, and transportation to and from
treatment facilities.
(5) Additional permissible uses.--In addition to the uses
described in paragraph (4), a grant awarded under this
section may be used, directly or through contractual
arrangements, to provide--
(A) all drugs approved by the Food and Drug Administration
to treat substance use disorders, pursuant to Federal and
State law;
(B) withdrawal and detoxification services that include
patient evaluation, stabilization, and preparation for
treatment of substance use disorder, including treatment
described in subparagraph (A), as appropriate; or
(C) mental health services provided by a program counselor,
social worker, therapist, or other certified professional who
is licensed and qualified by education, training, or
experience to assess the psychosocial background of patients,
to contribute to the appropriate treatment plan for patients
with substance use disorder, and to monitor patient progress.
(6) Preference.--In awarding grants under this section, the
Secretary shall give preference to eligible entities that
meet any or all of the following criteria:
(A) The eligible entity is a critical access hospital (as
defined in section 1861(mm)(1) of the Social Security Act (42
U.S.C. 1395x(mm)(1))), a low volume hospital (as defined in
section 1886(d)(12)(C)(i) of such Act (42 U.S.C.
1395ww(d)(12)(C)(i))), or a sole community hospital (as
defined in section 1886(d)(5)(D)(iii) of such Act (42 U.S.C.
1395ww(d)(5)(D)(iii))).
(B) The eligible entity is located in a State, or under the
jurisdiction of an Indian Tribe, with an age-adjusted rate of
drug overdose deaths that is above the national overdose
mortality rate, as determined by the Director of the Centers
for Disease Control and Prevention.
(C) The eligible entity demonstrates that recovery coaches
will be placed in both health care settings and community
settings.
(7) Period of grant.--A grant awarded to an eligible entity
under this section shall be for a period of not more than 5
years.
(c) Definitions.--In this section:
(1) Recovery coach.--the term ``recovery coach'' means an
individual--
(A) with knowledge of, or experience with, recovery from a
substance use disorder; and
(B) who has completed training from, and is determined to
be in good standing by, a recovery services organization
capable of conducting such training and making such
determination.
(2) Recovery community organization.--The term ``recovery
community organization'' has the meaning given such term in
section 547(a) of the Public Health Service Act (42 U.S.C.
290ee-2(a)).
(3) State alcohol and drug agency.--The term ``State
alcohol and drug agency'' means the principal agency of a
State that is responsible for carrying out the block grant
for prevention and treatment of substance abuse under subpart
II of part B of title XIX of the Public Health Service Act
(42 U.S.C. 300x-21 et seq.)
(d) Reporting Requirements.--
(1) Reports by grantees.--Each eligible entity awarded a
grant under this section
[[Page S6070]]
shall submit to the Secretary an annual report for each year
for which the entity has received such grant that includes
information on--
(A) the number of individuals treated by the entity for
non-fatal overdoses, including the number of non-fatal
overdoses where overdose reversal medication was
administered;
(B) the number of individuals administered medication-
assisted treatment by the entity;
(C) the number of individuals referred by the entity to
other treatment facilities after a non-fatal overdose, the
types of such other facilities, and the number of such
individuals admitted to such other facilities pursuant to
such referrals; and
(D) the frequency and number of patients with
reoccurrences, including readmissions for non-fatal overdoses
and evidence of relapse related to substance use disorder.
(2) Report by secretary.--Not later than 5 years after the
date of enactment of this Act, the Secretary shall submit to
Congress a report that includes an evaluation of the
effectiveness of the grant program carried out under this
section with respect to long term health outcomes of the
population of individuals who have experienced a drug
overdose, the percentage of patients treated or referred to
treatment by grantees, and the frequency and number of
patients who experienced relapse, were readmitted for
treatment, or experienced another overdose.
(e) Privacy.--The requirements of this section, including
with respect to data reporting and program oversight, shall
be subject to all applicable Federal and State privacy laws.
(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2019 through 2023.
SEC. 1403. ALTERNATIVES TO OPIOIDS.
(a) In General.--The Secretary shall, directly or through
grants to, or contracts with, public and private entities,
provide technical assistance to hospitals and other acute
care settings on alternatives to opioids for pain management.
The technical assistance provided shall be for the purpose
of--
(1) utilizing information from acute care providers
including emergency departments and other providers that have
successfully implemented alternatives to opioids programs,
promoting non-addictive protocols and medications while
appropriately limiting the use of opioids;
(2) identifying or facilitating the development of best
practices on the use of alternatives to opioids, which may
include pain-management strategies that involve non-addictive
medical products, non-pharmacologic treatments, and
technologies or techniques to identify patients at risk for
opioid use disorder;
(3) identifying or facilitating the development of best
practices on the use of alternatives to opioids that target
common painful conditions and include certain patient
populations, such as geriatric patients, pregnant women, and
children;
(4) disseminating information on the use of alternatives to
opioids to providers in acute care settings, which may
include emergency departments, outpatient clinics, critical
access hospitals, Federally qualified health centers, Indian
Health Service health facilities, and tribal hospitals; and
(5) collecting data and reporting on health outcomes
associated with the use of alternatives to opioids.
(b) Pain Management and Funding.--
(1) In general.--The Secretary shall award grants to
hospitals and other acute care settings relating to
alternatives to opioids for pain management.
(2) Authorization of appropriations.--There is authorized
to be appropriated $5,000,000 for each of fiscal years 2019
through 2023 for purposes of carrying out this section.
SEC. 1404. BUILDING COMMUNITIES OF RECOVERY.
Section 547 of the Public Health Service Act (42 U.S.C.
290ee-2) is amended to read as follows:
``SEC. 547. BUILDING COMMUNITIES OF RECOVERY.
``(a) Definition.--In this section, the term `recovery
community organization' means an independent nonprofit
organization that--
``(1) mobilizes resources within and outside of the
recovery community, which may include through a peer support
network, to increase the prevalence and quality of long-term
recovery from substance use disorders; and
``(2) is wholly or principally governed by people in
recovery for substance use disorders who reflect the
community served.
``(b) Grants Authorized.--The Secretary shall award grants
to recovery community organizations to enable such
organizations to develop, expand, and enhance recovery
services.
``(c) Federal Share.--The Federal share of the costs of a
program funded by a grant under this section may not exceed
85 percent.
``(d) Use of Funds.--Grants awarded under subsection (b)--
``(1) shall be used to develop, expand, and enhance
community and statewide recovery support services; and
``(2) may be used to--
``(A) build connections between recovery networks,
including between recovery community organizations and peer
support networks, and with other recovery support services,
including--
``(i) behavioral health providers;
``(ii) primary care providers and physicians;
``(iii) educational and vocational schools;
``(iv) employers;
``(v) housing services;
``(vi) child welfare agencies; and
``(vii) other recovery support services that facilitate
recovery from substance use disorders, including non-clinical
community services;
``(B) reduce the stigma associated with substance use
disorders; and
``(C) conduct outreach on issues relating to substance use
disorders and recovery, including--
``(i) identifying the signs of substance use disorder;
``(ii) the resources available to individuals with
substance use disorder and to families of an individual with
a substance use disorder, including programs that mentor and
provide support services to children;
``(iii) the resources available to help support individuals
in recovery; and
``(iv) related medical outcomes of substance use disorders,
the potential of acquiring an infection commonly associated
with illicit drug use, and neonatal abstinence syndrome among
infants exposed to opioids during pregnancy.
``(e) Special Consideration.--In carrying out this section,
the Secretary shall give special consideration to the unique
needs of rural areas, including areas with an age-adjusted
rate of drug overdose deaths that is above the national
average and areas with a shortage of prevention and treatment
services.
``(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2019 through 2023.''.
SEC. 1405. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.
(a) Establishment.--The Secretary, acting through the
Assistant Secretary for Mental Health and Substance Abuse,
shall establish or operate a National Peer-Run Training and
Technical Assistance Center for Addiction Recovery Support
(referred to in this subsection as the ``Center'').
(b) Functions.--The Center established under subsection (a)
shall provide technical assistance and support to recovery
community organizations and peer support networks, including
such assistance and support related to--
(1) training on identifying--
(A) signs of substance use disorder;
(B) resources to assist individuals with a substance use
disorder, or resources for families of an individual with a
substance use disorder; and
(C) best practices for the delivery of recovery support
services;
(2) the provision of translation services, interpretation,
or other such services for clients with limited English
speaking proficiency;
(3) data collection to support research, including for
translational research;
(4) capacity building; and
(5) evaluation and improvement, as necessary, of the
effectiveness of such services provided by recovery community
organizations (as defined in section 547 of the Public Health
Service Act).
(c) Best Practices.--The Center established under
subsection (a) shall periodically issue best practices for
use by recovery community organizations and peer support
networks.
(d) Recovery Community Organization.--In this section, the
term ``recovery community organization'' has the meaning
given such term in section 547 of the Public Health Service
Act.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2019 through 2023.
SEC. 1406. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM
ADDICTION.
(a) Waivers for Maintenance Treatment or Detoxification.--
Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21
U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the
following:
``(VIII) The physician graduated in good standing from an
accredited school of allopathic medicine or osteopathic
medicine in the United States during the 5-year period
immediately preceding the date on which the physician submits
to the Secretary a written notification under subparagraph
(B) and successfully completed a comprehensive allopathic or
osteopathic medicine curriculum or accredited medical
residency that--
``(aa) included not less than 24 hours of training on
treating and managing opioid-dependent patients; and
``(bb) included, at a minimum--
``(AA) the training described in items (aa) through (gg) of
subclause (IV); and
``(BB) training with respect to any other best practice the
Secretary determines should be included in the curriculum,
which may include training on pain management, including
assessment and appropriate use of opioid and non-opioid
alternatives.''.
(b) Treatment for Children.--The Secretary shall consider
ways to ensure that an adequate number of physicians who meet
the requirements under the amendment made by subsection (a)
and have a specialty in pediatrics, or the treatment of
children or of adolescents, are granted a waiver under
section 303(g)(2) of the Controlled Substances Act (21
[[Page S6071]]
U.S.C. 823(g)(2)) to treat children and adolescents with
substance use disorders.
(c) Technical Amendment.--Section 102(24) of the Controlled
Substances Act (21 U.S.C. 802(24)) is amended by striking
``Health, Education, and Welfare'' and inserting ``Health and
Human Services''.
SEC. 1407. GRANT PROGRAM.
(a) In General.--The Secretary shall establish a grant
program under which the Secretary may make grants to
accredited schools of allopathic medicine or osteopathic
medicine and teaching hospitals located in the United States
to support the development of curricula that meet the
requirements under subclause (VIII) of section
303(g)(2)(G)(ii) of the Controlled Substances Act, as added
by section 1406(a) of this Act.
(b) Authorization of Appropriations.--There is authorized
to be appropriated for grants under subsection (a),
$4,000,000 for each of fiscal years 2019 through 2023.
SEC. 1408. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO
MEDICATION-ASSISTED TREATMENT FOR OPIOID USE
DISORDERS.
Subclause (II) of section 303(g)(2)(B)(iii) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is
amended to read as follows:
``(II) The applicable number is--
``(aa) 100 if, not sooner than 1 year after the date on
which the practitioner submitted the initial notification,
the practitioner submits a second notification to the
Secretary of the need and intent of the practitioner to treat
up to 100 patients; or
``(bb) 275 if the practitioner meets the requirements
specified in section 8.610 of title 42, Code of Federal
Regulations (or successor regulations).''.
SEC. 1409. NATIONAL RECOVERY HOUSING BEST PRACTICES.
(a) Best Practices for Operating Recovery Housing.--
(1) In general.--The Secretary, in consultation with the
individuals and entities described in paragraph (2), shall
identify or facilitate the development of best practices,
which may include model laws for implementing suggested
minimum standards, for operating recovery housing.
(2) Consultation.--In carrying out the activities described
in paragraph (1) the Secretary shall consult with, as
appropriate--
(A) relevant divisions of the Department of Health and
Human Services, including the Substance Abuse and Mental
Health Services Administration, the Office of Inspector
General, the Indian Health Service, and the Centers for
Medicare & Medicaid Services;
(B) the Secretary of Housing and Urban Development;
(C) directors or commissioners, as applicable, of State
health departments, tribal health departments, State Medicaid
programs, and State insurance agencies;
(D) representatives of health insurance issuers;
(E) national accrediting entities and reputable providers
of, and analysts of, recovery housing services, including
Indian Tribes, tribal organizations, and tribally designated
housing entities that provide recovery housing services, as
applicable;
(F) individuals with a history of substance use disorder;
and
(G) other stakeholders identified by the Secretary.
(b) Identification of Fraudulent Recovery Housing
Operators.--
(1) In general.--The Secretary, in consultation with the
individuals and entities described in paragraph (2), shall
identify or facilitate the development of common indicators
that could be used to identify potentially fraudulent
recovery housing operators.
(2) Consultation.--In carrying out the activities described
in paragraph (1), the Secretary shall consult with, as
appropriate--
(A) relevant divisions of the Department of Health and
Human Services, including the Substance Abuse and Mental
Health Services Administration, the Office of Inspector
General, the Indian Health Service, and the Centers for
Medicare & Medicaid Services;
(B) the Attorney General;
(C) the Secretary of Housing and Urban Development;
(D) directors or commissioners, as applicable, of State
health departments, tribal health departments, State Medicaid
programs, and State insurance agencies;
(E) representatives of health insurance issuers;
(F) national accrediting entities and reputable providers
of, and analysts of, recovery housing services, including
Indian Tribes, tribal organizations, and tribally designated
housing entities that provide recovery housing services, as
applicable;
(G) individuals with a history of substance use disorder;
and
(H) other stakeholders identified by the Secretary.
(3) Requirements.--
(A) Practices for identification and reporting.--In
carrying out the activities described in this subsection, the
Secretary shall consider how law enforcement, public and
private payers, and the public can best identify and report
fraudulent recovery housing operators.
(B) Factors to be considered.--In carrying out the
activities described in this subsection, the Secretary shall
consider identifying or developing indicators regarding--
(i) unusual billing practices;
(ii) average lengths of stays;
(iii) excessive levels of drug testing (in terms of cost or
frequency);
(iv) unusually high levels of recidivism; and
(v) any other factors identified by the Secretary.
(c) Dissemination.--The Secretary shall, as appropriate,
disseminate the best practices identified or developed under
subsection (a), and the common indicators identified or
developed under subsection (b), to--
(1) State agencies, which may include the provision of
technical assistance to State agencies seeking to adopt or
implement such best practices;
(2) Indian Tribes, tribal organizations, and tribally
designated housing entities;
(3) the Attorney General;
(4) the Secretary of Labor;
(5) the Secretary of Housing and Urban Development;
(6) State and local law enforcement agencies;
(7) health insurance issuers;
(8) recovery housing entities; and
(9) the public.
(d) Requirements.--In carrying out the activities under
subsections (a) and (b), the Secretary, in consultation with
appropriate stakeholders as described in each such
subsection, shall consider how recovery housing is able to
support recovery and prevent relapse, recidivism, or overdose
(including overdose death), including by improving access and
adherence to treatment, including medication-assisted
treatment.
(e) Rule of Construction.--Nothing in this section shall be
construed to provide the Secretary with the authority to
require States to adhere to minimum standards in the State
oversight of recovery housing.
(f) Definitions.--In this section--
(1) the term ``recovery housing'' means a shared living
environment free from alcohol and illicit drug use and
centered on peer support and connection to services that
promote sustained recovery from substance use disorders; and
(2) the term ``tribally designated housing entity'' has the
meaning given such term in section 4 of the Native American
Housing Assistance and Self-Determination Act of 1996 (25
U.S.C. 4103).
SEC. 1410. ADDRESSING ECONOMIC AND WORKFORCE IMPACTS OF THE
OPIOID CRISIS.
(a) Definitions.--Except as otherwise expressly provided,
in this section:
(1) WIOA definitions.--The terms ``core program'',
``individual with a barrier to employment'', ``local area'',
``local board'', ``one-stop operator'', ``outlying area'',
``State'', ``State board'', and ``supportive services'' have
the meanings given the terms in section 3 of the Workforce
Innovation and Opportunity Act (29 U.S.C. 3102).
(2) Education provider.--The term ``education provider''
means--
(A) an institution of higher education, as defined in
section 101 of the Higher Education Act of 1965 (20 U.S.C.
1001); or
(B) a postsecondary vocational institution, as defined in
section 102(c) of such Act (20 U.S.C. 1002(c)).
(3) Eligible entity.--The term ``eligible entity'' means--
(A) a State workforce agency;
(B) an outlying area; or
(C) a Tribal entity.
(4) Participating partnership.--The term ``participating
partnership'' means a partnership--
(A) evidenced by a written contract or agreement; and
(B) including, as members of the partnership, a local board
receiving a subgrant under subsection (d) and 1 or more of
the following:
(i) The eligible entity.
(ii) A treatment provider.
(iii) An employer or industry organization.
(iv) An education provider.
(v) A legal service or law enforcement organization.
(vi) A faith-based or community-based organization.
(vii) Other State or local agencies, including counties or
local governments.
(viii) Other organizations, as determined to be necessary
by the local board.
(ix) Indian Tribes or tribal organizations.
(5) Program participant.--The term ``program participant''
means an individual who--
(A) is a member of a population of workers described in
subsection (e)(2) that is served by a participating
partnership through the pilot program under this section; and
(B) enrolls with the applicable participating partnership
to receive any of the services described in subsection
(e)(3).
(6) Provider of peer recovery support services.--The term
``provider of peer recovery support services'' means a
provider that delivers peer recovery support services through
an organization described in section 547(a) of the Public
Health Service Act (42 U.S.C. 290ee-2(a)).
(7) Secretary.--The term ``Secretary'' means the Secretary
of Labor.
(8) State workforce agency.--The term ``State workforce
agency'' means the lead State agency with responsibility for
the administration of a program under chapter 2 or 3 of
subtitle B of title I of the Workforce Innovation and
Opportunity Act (29 U.S.C. 3161 et seq., 3171 et seq.).
(9) Substance use disorder.--The term ``substance use
disorder'' has the meaning given such term by the Assistant
Secretary for Mental Health and Substance Use.
(10) Treatment provider.--The term ``treatment provider''--
(A) means a health care provider that--
[[Page S6072]]
(i) offers services for treating substance use disorders
and is licensed in accordance with applicable State law to
provide such services; and
(ii) accepts health insurance for such services, including
coverage under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.); and
(B) may include--
(i) a nonprofit provider of peer recovery support services;
(ii) a community health care provider;
(iii) a Federally qualified health center (as defined in
section 1861(aa) of the Social Security Act (42 U.S.C.
1395x));
(iv) an Indian health program (as defined in section 3 of
the Indian Health Care Improvement Act (25 U.S.C. 1603)),
including an Indian health program that serves an urban
center (as defined in such section); and
(v) a Native Hawaiian health center (as defined in section
12 of the Native Hawaiian Health Care Improvement Act (42
U.S.C. 11711)).
(11) Tribal entity.--The term ``Tribal entity'' includes
any Indian Tribe, tribal organization, Indian-controlled
organization serving Indians, Native Hawaiian organization,
or Alaska Native entity, as such terms are defined or used in
section 166 of the Workforce Innovation and Opportunity Act
(29 U.S.C. 3221).
(b) Pilot Program and Grants Authorized.--
(1) In general.--The Secretary, in consultation with the
Secretary of Health and Human Services, shall carry out a
pilot program to address economic and workforce impacts
associated with a high rate of a substance use disorder. In
carrying out the pilot program, the Secretary shall make
grants, on a competitive basis, to eligible entities to
enable such entities to make subgrants to local boards to
address the economic and workforce impacts associated with a
high rate of a substance use disorder.
(2) Grant amounts.--The Secretary shall make each such
grant in an amount that is not less than $500,000, and not
more than $5,000,000, for a fiscal year.
(c) Grant Applications.--
(1) In general.--An eligible entity applying for a grant
under this section shall submit an application to the
Secretary at such time and in such form and manner as the
Secretary may reasonably require, including the information
described in this subsection.
(2) Significant impact on community by opioid and substance
use disorder-related problems.--
(A) Demonstration.--An eligible entity shall include in the
application--
(i) information that demonstrates significant impact on the
community by problems related to opioid abuse or another
substance use disorder, by--
(I) identifying the counties, communities, regions, or
local areas that have been significantly impacted and will be
served through the grant (each referred to in this section as
a ``service area''); and
(II) demonstrating for each such service area, an increase
equal to or greater than the national increase in such
problems, between--
(aa) 1999; and
(bb) 2016 or the latest year for which data are available;
and
(ii) a description of how the eligible entity will
prioritize support for significantly impacted service areas
described in clause (i)(I).
(B) Information.--To meet the requirements described in
subparagraph (A)(i)(II), the eligible entity may use
information including data on--
(i) the incidence or prevalence of opioid abuse and other
substance use disorders;
(ii) the age-adjusted rate of drug overdose deaths, as
determined by the Director of the Centers for Disease Control
and Prevention;
(iii) the rate of non-fatal hospitalizations related to
opioid abuse or other substance use disorders;
(iv) the number of arrests or convictions, or a relevant
law enforcement statistic, that reasonably shows an increase
in opioid abuse or another substance use disorder; or
(v) in the case of an eligible entity described in
subsection (a)(3)(C), other alternative relevant data as
determined appropriate by the Secretary.
(C) Support for state strategy.--The eligible entity may
include in the application information describing how the
proposed services and activities are aligned with the State,
outlying area, or Tribal strategy, as applicable, for
addressing problems described in subparagraph (A) in specific
service areas or across the State, outlying area, or Tribal
land.
(3) Economic and employment conditions demonstrate
additional federal support needed.--
(A) Demonstration.--An eligible entity shall include in the
application information that demonstrates that a high rate of
a substance use disorder has caused, or is coincident to--
(i) an economic or employment downturn in the service area;
or
(ii) persistent economically depressed conditions in such
service area.
(B) Information.--To meet the requirements of subparagraph
(A), an eligible entity may use information including--
(i) documentation of any layoff, announced future layoff,
legacy industry decline, decrease in an employment or labor
market participation rate, or economic impact, whether or not
the result described in this clause is overtly related to a
high rate of a substance use disorder;
(ii) documentation showing decreased economic activity
related to, caused by, or contributing to a high rate of a
substance use disorder, including a description of how the
service area has been impacted, or will be impacted, by such
a decrease;
(iii) information on economic indicators, labor market
analyses, information from public announcements, and
demographic and industry data;
(iv) information on rapid response activities (as defined
in section 3 of the Workforce Innovation and Opportunity Act
(29 U.S.C. 3102)) that have been or will be conducted,
including demographic data gathered by employer or worker
surveys or through other methods;
(v) data or documentation, beyond anecdotal evidence,
showing that employers face challenges filling job vacancies
due to a lack of skilled workers able to pass a drug test; or
(vi) any additional relevant data or information on the
economy, workforce, or another aspect of the service area to
support the application.
(d) Subgrant Authorization and Application Process.--
(1) Subgrants authorized.--
(A) In general.--An eligible entity receiving a grant under
subsection (b)--
(i) may use not more than 5 percent of the grant funds for
the administrative costs of carrying out the grant;
(ii) in the case of an eligible entity described in
subparagraph (A) or (B) of subsection (a)(3), shall use the
remaining grant funds to make subgrants to local entities in
the service area to carry out the services and activities
described in subsection (e); and
(iii) in the case of an eligible entity described in
subsection (a)(3)(C), shall use the remaining grant funds to
carry out the services and activities described in subsection
(e).
(B) Equitable distribution.--In making subgrants under this
subsection, an eligible entity shall ensure, to the extent
practicable, the equitable distribution of subgrants, based
on--
(i) geography (such as urban and rural distribution); and
(ii) significantly impacted service areas as described in
subsection (c)(2).
(C) Timing of subgrant funds distribution.--An eligible
entity making subgrants under this subsection shall disburse
subgrant funds to a local board receiving a subgrant from the
eligible entity by the later of--
(i) the date that is 90 days after the date on which the
Secretary makes the funds available to the eligible entity;
or
(ii) the date that is 15 days after the date that the
eligible entity makes the subgrant under subparagraph
(A)(ii).
(2) Subgrant application.--
(A) In general.--A local board desiring to receive a
subgrant under this subsection from an eligible entity shall
submit an application at such time and in such manner as the
eligible entity may reasonably require, including the
information described in this paragraph.
(B) Contents.--Each application described in subparagraph
(A) shall include--
(i) an analysis of the estimated performance of the local
board in carrying out the proposed services and activities
under the subgrant--
(I) based on--
(aa) primary indicators of performance described in section
116(c)(1)(A)(i) of the Workforce Innovation and Opportunity
Act (29 U.S.C. 3141(c)(1)(A)(i), to assess estimated
effectiveness of the proposed services and activities,
including the estimated number of individuals with a
substance use disorder who may be served by the proposed
services and activities;
(bb) the record of the local board in serving individuals
with a barrier to employment; and
(cc) the ability of the local board to establish a
participating partnership; and
(II) which may include or utilize--
(aa) data from the National Center for Health Statistics of
the Centers for Disease Control and Prevention;
(bb) data from the Center for Behavioral Health Statistics
and Quality of the Substance Abuse and Mental Health Services
Administration;
(cc) State vital statistics;
(dd) municipal police department records;
(ee) reports from local coroners; or
(ff) other relevant data; and
(ii) in the case of a local board proposing to serve a
population described in subsection (e)(2)(B), a demonstration
of the workforce shortage in the professional area to be
addressed under the subgrant (which may include substance use
disorder treatment and related services, non-addictive pain
therapy and pain management services, mental health care
treatment services, emergency response services, or mental
health care), which shall include information that can
demonstrate such a shortage, such as--
(I) the distance between--
(aa) communities affected by opioid abuse or another
substance use disorder; and
(bb) facilities or professionals offering services in the
professional area; or
(II) the maximum capacity of facilities or professionals to
serve individuals in an affected community, or increases in
arrests related to opioid or another substance use disorder,
overdose deaths, or nonfatal overdose emergencies in the
community.
(e) Subgrant Services and Activities.--
[[Page S6073]]
(1) In general.--Each local board that receives a subgrant
under subsection (d) shall carry out the services and
activities described in this subsection through a
participating partnership.
(2) Selection of population to be served.--A participating
partnership shall elect to provide services and activities
under the subgrant to one or both of the following
populations of workers:
(A) Workers, including dislocated workers, individuals with
barriers to employment, new entrants in the workforce, or
incumbent workers (employed or underemployed), each of whom--
(i) is directly or indirectly affected by a high rate of a
substance use disorder; and
(ii) voluntarily confirms that the worker, or a friend or
family member of the worker, has a history of opioid abuse or
another substance use disorder.
(B) Workers, including dislocated workers, individuals with
barriers to employment, new entrants in the workforce, or
incumbent workers (employed or underemployed), who--
(i) seek to transition to professions that support
individuals with a substance use disorder or at risk for
developing such disorder, such as professions that provide--
(I) substance use disorder treatment and related services;
(II) services offered through providers of peer recovery
support services;
(III) non-addictive pain therapy and pain management
services;
(IV) emergency response services; or
(V) mental health care; and
(ii) need new or upgraded skills to better serve such a
population of struggling or at-risk individuals.
(3) Services and activities.--Each participating
partnership shall use funds available through a subgrant
under this subsection to carry out 1 or more of the
following:
(A) Engaging employers.--Engaging with employers to--
(i) learn about the skill and hiring requirements of
employers;
(ii) learn about the support needed by employers to hire
and retain program participants, and other individuals with a
substance use disorder, and the support needed by such
employers to obtain their commitment to testing creative
solutions to employing program participants and such
individuals;
(iii) connect employers and workers to on-the-job or
customized training programs before or after layoff to help
facilitate reemployment;
(iv) connect employers with an education provider to
develop classroom instruction to complement on-the-job
learning for program participants and such individuals;
(v) help employers develop the curriculum design of a work-
based learning program for program participants and such
individuals;
(vi) help employers employ program participants or such
individuals engaging in a work-based learning program for a
transitional period before hiring such a program participant
or individual for full-time employment of not less than 30
hours a week; or
(vii) connect employers to program participants receiving
concurrent outpatient treatment and job training services.
(B) Screening services.--Providing screening services,
which may include--
(i) using an evidence-based screening method to screen each
individual seeking participation in the pilot program to
determine whether the individual has a substance use
disorder;
(ii) conducting an assessment of each such individual to
determine the services needed for such individual to obtain
or retain employment, including an assessment of strengths
and general work readiness; or
(iii) accepting walk-ins or referrals from employers, labor
organizations, or other entities recommending individuals to
participate in such program.
(C) Individual treatment and employment plan.--Developing
an individual treatment and employment plan for each program
participant--
(i) in coordination, as appropriate, with other programs
serving the participant such as the core programs within the
workforce development system under the Workforce Innovation
and Opportunity Act (29 U.S.C. 3101 et seq.); and
(ii) which shall include providing a case manager to work
with each participant to develop the plan, which may
include--
(I) identifying employment and career goals;
(II) exploring career pathways that lead to in-demand
industries and sectors, as determined by the State board and
the head of the State workforce agency or, as applicable, the
Tribal entity;
(III) setting appropriate achievement objectives to attain
the employment and career goals identified under subclause
(I); or
(IV) developing the appropriate combination of services to
enable the participant to achieve the employment and career
goals identified under subclause (I).
(D) Outpatient treatment and recovery care.--In the case of
a participating partnership serving program participants
described in paragraph (2)(A) with a substance use disorder,
providing individualized and group outpatient treatment and
recovery services for such program participants that are
offered during the day and evening, and on weekends. Such
treatment and recovery services--
(i) shall be based on a model that utilizes combined
behavioral interventions and other evidence-based or
evidence-informed interventions; and
(ii) may include additional services such as--
(I) health, mental health, addiction, or other forms of
outpatient treatment that may impact a substance use disorder
and co-occurring conditions;
(II) drug testing for a current substance use disorder
prior to enrollment in career or training services or prior
to employment;
(III) linkages to community services, including services
offered by partner organizations designed to support program
participants; or
(IV) referrals to health care, including referrals to
substance use disorder treatment and mental health services.
(E) Supportive services.--Providing supportive services,
which shall include services such as--
(i) coordinated wraparound services to provide maximum
support for program participants to assist the program
participants in maintaining employment and recovery for not
less than 12 months, as appropriate;
(ii) assistance in establishing eligibility for assistance
under Federal, State, Tribal, and local programs providing
health services, mental health services, vocational services,
housing services, transportation services, social services,
or services through early childhood education programs (as
defined in section 103 of the Higher Education Act of 1965
(20 U.S.C. 1003));
(iii) services offered through providers of peer recovery
support services;
(iv) networking and mentorship opportunities; or
(v) any supportive services determined necessary by the
local board.
(F) Career and job training services.--Offering career
services and training services, and related services,
concurrently or sequentially with the services provided under
subparagraphs (B) through (E). Such services shall include
the following:
(i) Services provided to program participants who are in a
pre-employment stage of the program, which may include--
(I) initial education and skills assessments;
(II) traditional classroom training funded through
individual training accounts under chapter 3 of subtitle B of
title I of the Workforce Innovation and Opportunity Act (29
U.S.C. 3171 et seq.);
(III) services to promote employability skills such as
punctuality, personal maintenance skills, and professional
conduct;
(IV) in-depth interviewing and evaluation to identify
employment barriers and to develop individual employment
plans;
(V) career planning that includes--
(aa) career pathways leading to in-demand, high-wage jobs;
and
(bb) job coaching, job matching, and job placement
services;
(VI) provision of payments and fees for employment and
training-related applications, tests, and certifications; or
(VII) any other appropriate career service or training
service described in section 134(c) of the Workforce
Innovation and Opportunity Act (29 U.S.C. 3174(c)).
(ii) Services provided to program participants during their
first 6 months of employment to ensure job retention, which
may include--
(I) case management and support services, including a
continuation of the services described in clause (i);
(II) a continuation of skills training, and career and
technical education, described in clause (i) that is
conducted in collaboration with the employers of such
participants;
(III) mentorship services and job retention support for
such participants; or
(IV) targeted training for managers and workers working
with such participants (such as mentors), and human resource
representatives in the business in which such participants
are employed.
(iii) Services to assist program participants in
maintaining employment for not less than 12 months, as
appropriate.
(G) Proven and promising practices.--Leading efforts in the
service area to identify and promote proven and promising
strategies and initiatives for meeting the needs of employers
and program participants.
(4) Limitations.--A participating partnership may not use--
(A) more than 10 percent of the funds received under a
subgrant under subsection (d) for the administrative costs of
the partnership;
(B) more than 10 percent of the funds received under such
subgrant for the provision of treatment and recovery
services, as described in paragraph (3)(D); and
(C) more than 10 percent of the funds received under such
subgrant for the provision of supportive services described
in paragraph (3)(E) to program participants.
(f) Performance Accountability.--
(1) Reports.--The Secretary shall establish quarterly
reporting requirements for recipients of grants and subgrants
under this section that, to the extent practicable, are based
on the performance accountability system under section 116 of
the Workforce Innovation and Opportunity Act (29 U.S.C. 3141)
and, in the case of a grant awarded to an eligible entity
described in subsection (a)(3)(C), section 166(h) of such Act
(29 U.S.C. 3221(h)), including the indicators described in
subsection (c)(1)(A)(i) of such section 116 and the
[[Page S6074]]
requirements for local area performance reports under
subsection (d) of such section 116.
(2) Evaluations.--
(A) Authority to enter into agreements.--The Secretary
shall ensure that an independent evaluation is conducted on
the pilot program carried out under this section to determine
the impact of the program on employment of individuals with
substance use disorders. The Secretary shall enter into an
agreement with eligible entities receiving grants under this
section to pay for all or part of such evaluation.
(B) Methodologies to be used.--The independent evaluation
required under this paragraph shall use experimental designs
using random assignment or, when random assignment is not
feasible, other reliable, evidence-based research
methodologies that allow for the strongest possible causal
inferences.
(g) Funding.--
(1) Covered fiscal year.--In this subsection, the term
``covered fiscal year'' means any of fiscal years 2018
through 2023.
(2) Using funding for national dislocated worker grants.--
Subject to paragraph (4) and notwithstanding section
132(a)(2)(A) and subtitle D of the Workforce Innovation and
Opportunity Act (29 U.S.C. 3172(a)(2)(A), 3221 et seq.), the
Secretary may use, to carry out the pilot program under this
section for a covered fiscal year--
(A) funds made available to carry out section 170 of such
Act (29 U.S.C. 3225) for that fiscal year;
(B) funds made available to carry out section 170 of such
Act that remain available for that fiscal year; and
(C) funds that remain available under section 172(f) of
such Act (29 U.S.C. 3227(f)).
(3) Availability of funds.--Funds appropriated under
section 136(c) of such Act (29 U.S.C. 3181(c)) and made
available to carry out section 170 of such Act for a fiscal
year shall remain available for use under paragraph (2) for a
subsequent fiscal year until expended.
(4) Limitation.--The Secretary may not use more than
$100,000,000 of the funds described in paragraph (2) for any
covered fiscal year under this section.
SEC. 1411. CAREER ACT.
(a) In General.--The Secretary, in consultation with the
Secretary of Labor, shall continue or establish a program to
support individuals in recovery from a substance use disorder
transition to independent living and the workforce.
(b) Grants Authorized.--In carrying out the activities
under this section, the Secretary shall, on a competitive
basis, award grants for a period of not more than 5 years to
entities to enable such entities to carry out evidence-based
programs to help individuals in recovery from a substance use
disorder transition from treatment to independent living and
the workforce. Such entities shall coordinate, as applicable,
with Indian tribes or tribal organizations (as applicable),
State boards and local boards (as defined in section 3 of the
Workforce Innovation and Opportunity Act (29 U.S.C. 3102),
lead State agencies with responsibility for a workforce
investment activity (as defined in such section 3), and State
agencies responsible for carrying out substance use disorder
prevention and treatment programs.
(c) Priority.--In awarding grants under this section, the
Secretary shall give priority to entities located in a State
with--
(1) an age-adjusted rate of drug overdose deaths that is
above the national overdose mortality rate, as determined by
the Director of the Centers for Disease Control and
Prevention;
(2) a rate of unemployment, based on data provided by the
Bureau of Labor Statistics for calendar years 2013 through
2017, that is above the national average; and
(3) a rate of labor force participation, based on data
provided by the Bureau of Labor Statistics for calendar years
2013 through 2017, that is below the national average.
(d) Preference.--In awarding grants under this section, the
Secretary shall, as appropriate, give preference to entities
located in an area with an age-adjusted rate of drug overdose
deaths that is above the national overdose mortality rate.
(e) Applications.--An eligible entity shall submit an
application at such time and in such manner as the Secretary
may require. In submitting an application, the entity shall
demonstrate the ability to partner with local stakeholders,
which may include local employers, community stakeholders,
the local workforce development board, and local and State
governments, to--
(1) identify gaps in the workforce due to the prevalence of
substance use disorders;
(2) in coordination with statewide employment and training
activities, including coordination and alignment of
activities carried out by entities provided grant funds under
section 1410, help individuals in recovery from a substance
use disorder transition into the workforce, including by
providing career services, training services as described in
paragraph (2) of section 134(c) of the Workforce Innovation
and Opportunity Act (29 U.S.C. 3174(c)), and related services
described in section 134(a)(3) of such Act (42 U.S.C.
3174(a)); and
(3) assist employers with informing their employees of the
resources, such as resources related to substance use
disorders that are available to their employees.
(f) Use of Funds.--An entity receiving a grant under this
section shall use the funds to conduct one or more of the
following activities:
(1) Hire case managers, care coordinators, providers of
peer recovery support services, as described in section
547(a) of the Public Health Service Act (42 U.S.C. 290ee-
2(a)), or other professionals, as appropriate, to provide
services that support treatment, recovery, and
rehabilitation, and prevent relapse, recidivism, and
overdose, including by encouraging--
(A) the development of daily living skills; and
(B) the use of counseling, care coordination, and other
services, as appropriate, to support recovery from substance
use disorders.
(2) Implement or utilize innovative technologies, which may
include the use of telemedicine.
(3) In coordination with the lead State agency with
responsibility for a workforce investment activity or local
board described in subsection (b), provide--
(A) short-term prevocational training services; and
(B) training services that are directly linked to the
employment opportunities in the local area or the planning
region.
(g) Support for State Strategy.--An eligible entity shall
include in its application under subsection (e) information
describing how the services and activities proposed in such
application are aligned with the State, outlying area, or
Tribal strategy, as applicable, for addressing issues
described in such application and how such entity will
coordinate with existing systems to deliver services as
described in such application.
(h) Authorization of Appropriations.--There is authorized
to be appropriated such sums as may be necessary for each of
fiscal years 2019 through 2023 for purposes of carrying out
this section.
SEC. 1412. PILOT PROGRAM TO HELP INDIVIDUALS IN RECOVERY FROM
A SUBSTANCE USE DISORDER BECOME STABLY HOUSED.
(a) Authorization of Appropriations.--There is authorized
to be appropriated under this section such sums as may be
necessary for each of fiscal years 2019 through 2023 for
assistance to States to provide individuals in recovery from
a substance use disorder stable, temporary housing for a
period of not more than 2 years or until the individual
secures permanent housing, whichever is earlier.
(b) Allocation of Appropriated Amounts.--
(1) In general.--The amounts appropriated or otherwise made
available to States under this section shall be allocated
based on a funding formula established by the Secretary of
Housing and Urban Development (referred to in this section as
the ``Secretary'') not later than 60 days after the date of
enactment of this Act.
(2) Criteria.--The funding formula required under paragraph
(1) shall ensure that any amounts appropriated or otherwise
made available under this section are allocated to States
with an age-adjusted rate of drug overdose deaths that is
above the national overdose mortality rate, according to the
Centers for Disease Control and Prevention. Among such
States, priority shall be given to States with the greatest
need, as such need is determined by the Secretary based on--
(A) the highest average rates of unemployment based on data
provided by the Bureau of Labor Statistics for calendar years
2013 through 2017;
(B) the lowest average labor force participation rates
based on data provided by the Bureau of Labor Statistics for
calendar years 2013 through 2017; and
(C) the highest prevalence of opioid use disorder based on
data provided by the Substance Abuse and Mental Health
Services Administration for calendar years 2013 through 2017.
(3) Distribution.--Amounts appropriated or otherwise made
available under this section shall be distributed according
to the funding formula established by the Secretary under
paragraph (1) not later than 30 days after the establishment
of such formula.
(c) Use of Funds.--
(1) In general.--Any State that receives amounts pursuant
to this section shall expend at least 30 percent of such
funds within one year of the date funds become available to
the grantee for obligation.
(2) Priority.--Any State that receives amounts pursuant to
this section shall distribute such amounts giving priority to
entities with the greatest need and ability to deliver
effective assistance in a timely manner.
(3) Administrative costs.--Any State that receives amounts
pursuant to this section may use up to 5 percent of any grant
for administrative costs.
(d) Rules of Construction.--
(1) In general.--Except as otherwise provided by this
section, amounts appropriated, or amounts otherwise made
available to States under this section shall be treated as
though such funds were community development block grant
funds under title I of the Housing and Community Development
Act of 1974 (42 U.S.C. 5301 et seq.).
(2) No match.--No matching funds shall be required in order
for a State to receive any amounts under this section.
(e) Authority to Waive or Specify Alternative
Requirements.--
(1) In general.--In administering any amounts appropriated
or otherwise made available under this section, the Secretary
may waive or specify alternative requirements for any
provision of any statute or
[[Page S6075]]
regulation in connection with the obligation by the Secretary
or the use of funds except for requirements related to fair
housing, nondiscrimination, labor standards, and the
environment, upon a finding that such a waiver is necessary
to expedite or facilitate the use of such funds.
(2) Notice.--The Secretary shall provide written notice of
its intent to exercise the authority to specify alternative
requirements under paragraph (1) to the Committee on Banking,
Housing, and Urban Affairs of the Senate and the Committee on
Financial Services of the House of Representatives not later
than 5 business days before such exercise of authority
occurs.
(f) Technical Assistance.--For the 2-year period following
the date of enactment of this Act, the Secretary may use not
more than 2 percent of the funds made available under this
section for technical assistance to grantees.
(g) State.--For purposes of this section the term ``State''
includes any State as defined in section 102 of the Housing
and Community Development Act of 1974 (42 U.S.C. 5302) and
the District of Columbia.
SEC. 1413. YOUTH PREVENTION AND RECOVERY.
(a) Substance Abuse Treatment Services for Children,
Adolescents, and Young Adults.--Section 514 of the Public
Health Service Act (42 U.S.C. 290bb-7) is amended--
(1) in the section heading, by striking ``children and
adolescents'' and inserting ``children, adolescents, and
young adults'';
(2) in subsection (a)(2), by striking ``children,
including'' and inserting ``children, adolescents, and young
adults, including''; and
(3) by striking ``children and adolescents'' each place it
appears and inserting ``children, adolescents, and young
adults''.
(b) Resource Center.--The Secretary, acting through the
Assistant Secretary for Mental Health and Substance Use and,
as appropriate, in consultation with the Secretary of
Education and other agencies, shall establish a resource
center to provide technical support to recipients of grants
under subsection (c).
(c) Youth Prevention and Recovery Initiative.--
(1) In general.--The Secretary, in consultation with the
Secretary of Education, shall administer a program to provide
support for communities to support the prevention of,
treatment of, and recovery from, substance use disorders for
children, adolescents, and young adults.
(2) Definitions.--In this subsection:
(A) Eligible entity.--The term ``eligible entity'' means--
(i) a local educational agency that is seeking to establish
or expand substance use prevention or recovery support
services at one or more high schools;
(ii) a State educational agency;
(iii) an institution of higher education (or consortia of
such institutions), which may include a recovery program at
an institution of higher education;
(iv) a local board or one-stop operator;
(v) a nonprofit organization with appropriate expertise in
providing services or programs for children, adolescents, or
young adults, excluding a school;
(vi) a State, political subdivision of a State, Indian
Tribe, or tribal organization; or
(vii) a high school or dormitory serving high school
students that receives funding from the Bureau of Indian
Education.
(B) Evidence-based.--The term ``evidence-based'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act (20 U.S.C. 7801).
(C) Foster care.--The term ``foster care'' has the meaning
given such term in section 1355.20(a) of title 45, Code of
Federal Regulations (or any successor regulations).
(D) High school.--The term ``high school'' has the meaning
given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(E) Homeless youth.--The term ``homeless youth'' has the
meaning given the term ``homeless children or youths'' in
section 725 of the McKinney-Vento Homeless Assistance Act (42
U.S.C. 11434a);
(F) Institution of higher education.--The term
``institution of higher education'' has the meaning given
such term in section 101 of the Higher Education Act of 1965
(20 U.S.C. 1001) and includes a ``postsecondary vocational
institution'' as defined in section 102(c) of such Act (20
U.S.C. 1002(c)).
(G) Local educational agency.--The term ``local educational
agency'' has the meaning given the term in section 8101 of
the Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801).
(H) Local board; one-stop operator.--The terms ``local
board'' and ``one-stop operator'' have the meanings given
such terms in section 3 of the Workforce Innovation and
Opportunity Act (29 U.S.C. 3102).
(I) Out of school youth.--The term ``out-of-school youth''
has the meaning given such term in section 129(a)(1)(B) of
the Workforce Innovation and Opportunity Act (29 U.S.C.
3164(a)(1)(B)).
(J) Recovery program.--The term ``recovery program'' means
a program--
(i) to help children, adolescents, or young adults who are
recovering from substance use disorders to initiate,
stabilize, and maintain healthy and productive lives in the
community; and
(ii) that includes peer-to-peer support delivered by
individuals with lived experience in recovery, and communal
activities to build recovery skills and supportive social
networks.
(K) State educational agency.--The term ``State educational
agency'' has the meaning given the term in section 8101 of
the Elementary and Secondary Education Act (20 U.S.C. 7801).
(3) Best practices.--The Secretary, in consultation with
the Secretary of Education, shall--
(A) identify or facilitate the development of evidence-
based best practices for prevention of substance misuse and
abuse by children, adolescents, and young adults, including
for specific populations such as youth in foster care,
homeless youth, out-of-school youth, and youth who are at
risk of or have experienced trafficking that address--
(i) primary prevention;
(ii) appropriate recovery support services;
(iii) appropriate use of medication-assisted treatment for
such individuals, if applicable, and ways of overcoming
barriers to the use of medication-assisted treatment in such
population; and
(iv) efficient and effective communication, which may
include the use of social media, to maximize outreach
efforts;
(B) disseminate such best practices to State educational
agencies, local educational agencies, schools and dormitories
funded by the Bureau of Indian Education, institutions of
higher education, recovery programs at institutions of higher
education, local boards, one-stop operators, family and youth
homeless providers, and nonprofit organizations, as
appropriate;
(C) conduct a rigorous evaluation of each grant funded
under this subsection, particularly its impact on the
indicators described in paragraph (8)(B); and
(D) provide technical assistance for grantees under this
subsection.
(4) Grants authorized.--The Secretary, in consultation with
the Secretary of Education, shall award 3-year grants, on a
competitive basis, to eligible entities to enable such
entities, in coordination with Indian Tribes, if applicable,
and State agencies responsible for carrying out substance use
disorder prevention and treatment programs, to carry out
evidence-based programs for--
(A) prevention of substance misuse and abuse by children,
adolescents, and young adults, which may include primary
prevention;
(B) recovery support services for children, adolescents,
and young adults, which may include counseling, job training,
linkages to community-based services, family support groups,
peer mentoring, and recovery coaching; or
(C) treatment or referrals for treatment of substance use
disorders, which may include the use of medication-assisted
treatment, as appropriate.
(5) Special consideration.--In awarding grants under this
subsection, the Secretary shall give special consideration to
the unique needs of tribal, urban, suburban, and rural
populations.
(6) Application.--To be eligible for a grant under this
subsection, an entity shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require. Such application
shall include--
(A) a description of--
(i) the impact of substance use disorders in the population
that will be served by the grant program;
(ii) how the eligible entity has solicited input from
relevant stakeholders, which may include faculty, teachers,
staff, families, students, and experts in substance use
prevention and treatment in developing such application;
(iii) the goals of the proposed project, including the
intended outcomes;
(iv) how the eligible entity plans to use grant funds for
evidence-based activities, in accordance with this subsection
to prevent, provide recovery support for, or treat substance
use disorders amongst such individuals, or a combination of
such activities; and
(v) how the eligible entity will collaborate with relevant
partners, which may include State educational agencies, local
educational agencies, institutions of higher education,
juvenile justice agencies, prevention and recovery support
providers, local service providers, including substance use
disorder treatment programs, providers of mental health
services, youth serving organizations, family and youth
homeless providers, child welfare agencies, and primary care
providers, in carrying out the grant program; and
(B) an assurance that the eligible entity will participate
in the evaluation described in paragraph (3)(C).
(7) Priority.--In awarding grants under this subsection,
the Secretary shall give priority to eligible entities that
propose to use grant funds for activities that meet the
criteria described in subclauses (I) and (II) of section
8101(21)(A)(i) of the Elementary and Secondary Education Act
(20 U.S.C. 7801(21)(A)(i)).
(8) Reports to the secretary.--Each eligible entity awarded
a grant under this subsection shall submit to the Secretary a
report at such time and in such manner as the Secretary may
require. Such report shall include--
(A) a description of how the eligible entity used grant
funds, in accordance with this subsection, including the
number of children, adolescents, and young adults reached
through programming; and
[[Page S6076]]
(B) a description, including relevant data, of how the
grant program has made an impact on the intended outcomes
described in paragraph (6)(A)(iii), including--
(i) indicators of student success, which, if the eligible
entity is an educational institution, shall include student
well-being and academic achievement;
(ii) substance use disorders amongst children, adolescents,
and young adults, including the number of overdoses and
deaths amongst children, adolescents, and young adults during
the grant period; and
(iii) other indicators, as the Secretary determines
appropriate.
(9) Report to congress.--The Secretary shall, not later
than October 1, 2022, submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate, and the
Committee on Energy and Commerce and the Committee on
Education and the Workforce of the House of Representatives,
a report summarizing the effectiveness of the grant program
under this subsection, based on the information submitted in
reports required under paragraph (8).
(10) Authorization of appropriations.--There is authorized
to be appropriated such sums as may be necessary to carry out
this subsection for each of fiscal years 2019 through 2023.
SEC. 1414. PLANS OF SAFE CARE.
Section 105(a) of the Child Abuse Prevention and Treatment
Act (42 U.S.C. 5106(a)) is amended by adding at the end the
following:
``(7) Grants to states to improve and coordinate their
response to ensure the safety, permanency, and well-being of
infants affected by substance use.--
``(A) Program authorized.--The Secretary shall make grants
to States for the purpose of assisting child welfare
agencies, social services agencies, substance use disorder
treatment agencies, hospitals with labor and delivery units,
medical staff, public health and mental health agencies, and
maternal and child health agencies to facilitate
collaboration in developing, updating, implementing, and
monitoring plans of safe care described in section
106(b)(2)(B)(iii).
``(B) Distribution of funds.--
``(i) Reservations.--Of the amounts appropriated under
subparagraph (H), the Secretary shall reserve--
``(I) no more than 3 percent for the purposes described in
subparagraph (G); and
``(II) up to 3 percent for grants to Indian Tribes and
tribal organizations to address the needs of infants born
with, and identified as being affected by, substance abuse or
withdrawal symptoms resulting from prenatal drug exposure or
a fetal alcohol spectrum disorder and their families or
caregivers, which to the extent practicable, shall be
consistent with the uses of funds described under
subparagraph (D).
``(ii) Allotments to states and territories.--The Secretary
shall allot the amount appropriated under subparagraph (H)
that remains after application of clause (i) to each State
that applies for such a grant, in an amount equal to the sum
of--
``(I) $500,000; and
``(II) an amount that bears the same relationship to any
funds appropriated under subparagraph (H) and remaining after
application of clause (i), as the number of live births in
the State in the previous calendar year bears to the number
of live births in all States in such year.
``(iii) Ratable reduction.--If the amount appropriated
under subparagraph (H) is insufficient to satisfy the
requirements of clause (ii), the Secretary shall ratably
reduce each allotment to a State.
``(C) Application.--A State desiring a grant under this
paragraph shall submit an application to the Secretary at
such time and in such manner as the Secretary may require.
Such application shall include--
``(i) a description of--
``(I) the impact of substance use disorder in such State,
including with respect to the substance or class of
substances with the highest incidence of abuse in the
previous year in such State, including--
``(aa) the prevalence of substance use disorder in such
State;
``(bb) the aggregate rate of births in the State of infants
affected by substance abuse or withdrawal symptoms or a fetal
alcohol spectrum disorder (as determined by hospitals,
insurance claims, claims submitted to the State Medicaid
program, or other records), if available and to the extent
practicable; and
``(cc) the number of infants identified, for whom a plan of
safe care was developed, and for whom a referral was made for
appropriate services, as reported under section 106(d)(18);
``(II) the challenges the State faces in developing,
implementing, and monitoring plans of safe care in accordance
with section 106(b)(2)(B)(iii);
``(III) the State's lead agency for the grant program and
how that agency will coordinate with relevant State entities
and programs, including the child welfare agency, the
substance use disorder treatment agency, hospitals with labor
and delivery units, health care providers, the public health
and mental health agencies, programs funded by the Substance
Abuse and Mental Health Services Administration that provide
substance use disorder treatment for women, the State
Medicaid program, the State agency administering the block
grant program under title V of the Social Security Act (42
U.S.C. 701 et seq.), the State agency administering the
programs funded under part C of the Individuals with
Disabilities Education Act (20 U.S.C. 1431 et seq.), the
maternal, infant, and early childhood home visiting program
under section 511 of the Social Security Act (42 U.S.C. 711),
the State judicial system, and other agencies, as determined
by the Secretary, and Indian Tribes and tribal organizations,
as appropriate;
``(IV) how the State will monitor local development and
implementation of plans of safe care, in accordance with
section 106(b)(2)(B)(iii)(II), including how the State will
monitor to ensure plans of safe care address differences
between substance use disorder and medically supervised
substance use, including for the treatment of a substance use
disorder;
``(V) how the State meets the requirements of section 1927
of the Public Health Service Act (42 U.S.C. 300x-27);
``(VI) how the State plans to utilize funding authorized
under part E of title IV of the Social Security Act (42
U.S.C. 670 et seq.) to assist in carrying out any plan of
safe care, including such funding authorized under section
471(e) of such Act (as in effect on October 1, 2018) for
mental health and substance abuse prevention and treatment
services and in-home parent skill-based programs and funding
authorized under such section 472(j) (as in effect on October
1, 2018) for children with a parent in a licensed residential
family-based treatment facility for substance abuse; and
``(VII) an assessment of the treatment and other services
and programs available in the State, to effectively carry out
any plan of safe care developed, including identification of
needed treatment, and other services and programs to ensure
the well-being of young children and their families affected
by substance use disorder, such as programs carried out under
part C of the Individuals with Disabilities Education Act and
comprehensive early childhood development services and
programs such as Head Start programs;
``(ii) a description of how the State plans to use funds
for activities described in subparagraph (D) for the purposes
of ensuring State compliance with requirements under clauses
(ii) and (iii) of section 106(b)(2)(B); and
``(iii) an assurance that the State will--
``(I) comply with this Act and parts B and E of title IV of
the Social Security Act (42 U.S.C. 621 et seq., 670 et seq.);
and
``(II) comply with requirements to refer a child identified
as substance-exposed to early intervention services as
required pursuant to a grant under part C of the Individuals
with Disabilities Education Act (20 U.S.C. 1431 et seq.).
``(D) Uses of funds.--Funds awarded to a State under this
paragraph may be used for the following activities, which may
be carried out by the State directly, or through grants or
subgrants, contracts, or cooperative agreements:
``(i) Improving State and local systems with respect to the
development and implementation of plans of safe care, which--
``(I) shall include parent and caregiver engagement, as
required under section 106(b)(2)(B)(iii)(I), regarding
available treatment and service options, which may include
resources available for pregnant, perinatal, and postnatal
women; and
``(II) may include activities such as--
``(aa) developing policies, procedures, or protocols for
the administration or development of evidence-based and
validated screening tools for infants who may be affected by
substance use withdrawal symptoms or a fetal alcohol spectrum
disorder and pregnant, perinatal, and postnatal women whose
infants may be affected by substance use withdrawal symptoms
or a fetal alcohol spectrum disorder;
``(bb) improving assessments used to determine the needs of
the infant and family;
``(cc) improving ongoing case management services; and
``(dd) improving access to treatment services, which may be
prior to the pregnant woman's delivery date.
``(ii) Developing policies, procedures, or protocols in
consultation and coordination with health professionals,
public and private health facilities, and substance use
disorder treatment agencies to ensure that--
``(I) appropriate notification to child protective services
is made in a timely manner;
``(II) a plan of safe care is in place, in accordance with
section 106(b)(2)(B)(iii), before the infant is discharged
from the birth or health care facility; and
``(III) such health and related agency professionals are
trained on how to follow such protocols and are aware of the
supports that may be provided under a plan of safe care.
``(iii) Training health professionals and health system
leaders, child welfare workers, substance use disorder
treatment agencies, and other related professionals such as
home visiting agency staff and law enforcement in relevant
topics including--
``(I) State mandatory reporting laws and the referral and
process requirements for notification to child protective
services when child abuse or neglect reporting is not
mandated;
``(II) the co-occurrence of pregnancy and substance use
disorder, and implications of prenatal exposure;
``(III) the clinical guidance about treating substance use
disorder in pregnant and postpartum women;
``(IV) appropriate screening and interventions for infants
affected by substance use disorder, withdrawal symptoms, or a
fetal alcohol spectrum disorder and the requirements under
section 106(b)(2)(B)(iii); and
[[Page S6077]]
``(V) appropriate multigenerational strategies to address
the mental health needs of the parent and child together.
``(iv) Establishing partnerships, agreements, or memoranda
of understanding between the lead agency and health
professionals, health facilities, child welfare
professionals, juvenile and family court judges, substance
use and mental disorder treatment programs, early childhood
education programs, and maternal and child health and early
intervention professionals, including home visiting
providers, peer-to-peer recovery programs such as parent
mentoring programs, and housing agencies to facilitate the
implementation of, and compliance with section 106(b)(2) and
clause (ii) of this subparagraph, in areas which may
include--
``(I) developing a comprehensive, multi-disciplinary
assessment and intervention process for infants, pregnant
women, and their families who are affected by substance use
disorder, withdrawal symptoms, or a fetal alcohol spectrum
disorder, that includes meaningful engagement with and takes
into account the unique needs of each family and addresses
differences between medically supervised substance use,
including for the treatment of substance use disorder, and
substance use disorder;
``(II) ensuring that treatment approaches for serving
infants, pregnant women, and perinatal and postnatal women
whose infants may be affected by substance use, withdrawal
symptoms, or a fetal alcohol spectrum disorder, are designed
to, where appropriate, keep infants with their mothers during
both inpatient and outpatient treatment; and
``(III) increasing access to all evidence-based medication-
assisted treatment approved by the Food and Drug
Administration, behavioral therapy, and counseling services
for the treatment of substance use disorders, as appropriate.
``(v) Developing and updating systems of technology for
improved data collection and monitoring under section
106(b)(2)(B)(iii), including existing electronic medical
records, to measure the outcomes achieved through the plans
of safe care, including monitoring systems to meet the
requirements of this Act and submission of performance
measures.
``(E) Reporting.--Each State that receives funds under this
paragraph, for each year such funds are received, shall
submit a report to the Secretary, disaggregated by geographic
location, economic status, and major racial and ethnic
groups, except that such disaggregation shall not be required
if the results would reveal personally identifiable
information on, with respect to infants identified under
section 106(b)(2)(B)(ii)--
``(i) the number who experienced removal associated with
parental substance use;
``(ii) the number who experienced removal and subsequently
are reunified with parents, and the length of time between
such removal and reunification;
``(iii) the number who are referred to community providers
without a child protection case;
``(iv) the number who receive services while in the care of
their birth parents;
``(v) the number who receive post-reunification services
within 1 year after a reunification has occurred; and
``(vi) the number who experienced a return to out-of-home
care within 1 year after reunification.
``(F) Secretary's report to congress.--The Secretary shall
submit an annual report to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Education
and the Workforce and the Committee on Appropriations of the
House of Representatives that includes the information
described in subparagraph (E) and recommendations or
observations on the challenges, successes, and lessons
derived from implementation of the grant program.
``(G) Reservation of funds.--The Secretary shall use the
amount reserved under subparagraph (B)(i)(I) for the purposes
of--
``(i) providing technical assistance, including programs of
in-depth technical assistance, to additional States,
territories, and Indian Tribes and tribal organizations in
accordance with the substance-exposed infant initiative
developed by the National Center on Substance Abuse and Child
Welfare;
``(ii) issuing guidance on the requirements of this Act
with respect to infants born with and identified as being
affected by substance use or withdrawal symptoms or fetal
alcohol spectrum disorder, as described in clauses (ii) and
(iii) of section 106(b)(2)(B), including by--
``(I) clarifying key terms; and
``(II) disseminating best practices on implementation of
plans of safe care, on such topics as differential response,
collaboration and coordination, and identification and
delivery of services for different populations;
``(iii) supporting State efforts to develop information
technology systems to manage plans of safe care; and
``(iv) preparing the Secretary's report to Congress
described in subparagraph (F).
``(H) Authorization of appropriations.--To carry out the
program under this paragraph, there is authorized to be
appropriated $60,000,000 for each of fiscal years 2019
through 2023.''.
SEC. 1415. REGULATIONS RELATING TO SPECIAL REGISTRATION FOR
TELEMEDICINE.
Section 311(h) of the Controlled Substances Act (21 U.S.C.
831(h)) is amended by striking paragraph (2) and inserting
the following:
``(2) Regulations.--
``(A) In general.--Not later than 1 year after the date of
enactment of the Opioid Crisis Response Act of 2018, in
consultation with the Secretary, and in accordance with the
procedure described in subparagraph (B), the Attorney General
shall promulgate final regulations specifying--
``(i) the limited circumstances in which a special
registration under this subsection may be issued; and
``(ii) the procedure for obtaining a special registration
under this subsection.
``(B) Procedure.--In promulgating final regulations under
subparagraph (A), the Attorney General shall--
``(i) issue a notice of proposed rulemaking that includes a
copy of the proposed regulations;
``(ii) provide a period of not less than 60 days for
comments on the proposed regulations;
``(iii) finalize the proposed regulation not later than 6
months after the close of the comment period; and
``(iv) publish the final regulations not later than 30 days
before the effective date of the final regulations.''.
SEC. 1416. NATIONAL HEALTH SERVICE CORPS BEHAVIORAL AND
MENTAL HEALTH PROFESSIONALS PROVIDING OBLIGATED
SERVICE IN SCHOOLS AND OTHER COMMUNITY-BASED
SETTINGS.
Subpart III of part D of title III of the Public Health
Service Act (42 U.S.C. 254l et seq.) is amended by adding at
the end the following:
``SEC. 338N. BEHAVIORAL AND MENTAL HEALTH PROFESSIONALS
PROVIDING OBLIGATED SERVICE IN SCHOOLS AND
OTHER COMMUNITY-BASED SETTINGS.
``(a) Schools and Community-based Settings.--An entity to
which a participant in the Scholarship Program or the Loan
Repayment Program (referred to in this section as a
`participant') is assigned under section 333 may direct such
participant to provide service as a behavioral or mental
health professional at a school or other community-based
setting located in a health professional shortage area.
``(b) Obligated Service.--
``(1) In general.--Any service described in subsection (a)
that a participant provides may count towards such
participant's completion of any obligated service
requirements under the Scholarship Program or the Loan
Repayment Program, subject to any limitation imposed under
paragraph (2).
``(2) Limitation.--The Secretary may impose a limitation on
the number of hours of service described in subsection (a)
that a participant may credit towards completing obligated
service requirements, provided that the limitation allows a
member to credit service described in subsection (a) for not
less than 50 percent of the total hours required to complete
such obligated service requirements.
``(c) Rule of Construction.--The authorization under
subsection (a) shall be notwithstanding any other provision
of this subpart or subpart II.''.
SEC. 1417. LOAN REPAYMENT FOR SUBSTANCE USE DISORDER
TREATMENT PROVIDERS.
(a) Loan Repayment for Substance Use Treatment Providers.--
The Secretary shall enter into contracts under section 338B
of the Public Health Service Act (42 U.S.C. 254l-1) with
eligible health professionals providing substance use
disorder treatment services in substance use disorder
treatment facilities, as defined by the Secretary.
(b) Provision of Substance Use Disorder Treatment.--In
carrying out the activities described in subsection (a)--
(1) each such facility shall be located in or serving a
mental health professional shortage area designated under
section 332 of the Public Health Service Act (42 U.S.C.
254e), or, as the Secretary determines appropriate, an area
with an age-adjusted rate of drug overdose deaths that is
above the national overdose mortality rate;
(2) section 331(a)(3)(D) of such Act (42 U.S.C.
254d(a)(3)(D)) shall be applied as if the term ``primary
health services'' includes health services regarding
substance use disorder treatment and infections associated
with illicit drug use;
(3) section 331(a)(3)(E)(i) of such Act (42 U.S.C.
254d(a)(3)(E)(i)) shall be applied as if the term
``behavioral and mental health professionals'' includes
master's level, licensed substance use disorder treatment
counselors, and other relevant professionals or
paraprofessionals, as the Secretary determines appropriate;
and
(4) such professionals and facilities shall provide--
(A) directly, or through the use of telehealth technology,
and pursuant to Federal and State law, counseling by a
program counselor or other certified professional who is
licensed and qualified by education, training, or experience
to assess the psychological and sociological background of
patients, to contribute to the appropriate treatment plan for
the patient, and to monitor progress; and
(B) medication-assisted treatment, including, to the extent
practicable, all drugs approved by the Food and Drug
Administration to treat substance use disorders, pursuant to
Federal and State law.
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $25,000,000 for
each of fiscal years 2019 through 2023.
SEC. 1418. PROTECTING MOMS AND INFANTS.
(a) Report.--
[[Page S6078]]
(1) In general.--Not later than 60 days after the date of
enactment of this Act, the Secretary shall submit to the
appropriate committees of Congress and make available to the
public on the internet website of the Department of Health
and Human Services a report regarding the implementation of
the recommendations in the strategy relating to prenatal
opioid use, including neonatal abstinence syndrome, developed
pursuant to section 2 of the Protecting Our Infants Act of
2015 (Public Law 114-91). Such report shall include--
(A) an update on the implementation of the recommendations
in the strategy, including information regarding the agencies
involved in the implementation; and
(B) information on additional funding or authority the
Secretary requires, if any, to implement the strategy, which
may include authorities needed to coordinate implementation
of such strategy across the Department of Health and Human
Services.
(2) Periodic updates.--The Secretary shall periodically
update the report under paragraph (1).
(b) Residential Treatment Programs for Pregnant and
Postpartum Women.--Section 508(s) of the Public Health
Service Act (42 U.S.C. 290bb-1(s)) is amended by striking
``$16,900,000 for each of fiscal years 2017 through 2021''
and inserting ``$29,931,000 for each of fiscal years 2019
through 2023''.
SEC. 1419. EARLY INTERVENTIONS FOR PREGNANT WOMEN AND
INFANTS.
(a) Development of Educational Materials by Center for
Substance Abuse Prevention.--Section 515(b) of the Public
Health Service Act (42 U.S.C. 290bb-21(b)) is amended--
(1) in paragraph (13), by striking ``and'' at the end;
(2) in paragraph (14), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(15) in cooperation with relevant stakeholders and the
Director of the Centers for Disease Control and Prevention,
develop educational materials for clinicians to use with
pregnant women for shared decisionmaking regarding pain
management during pregnancy.''.
(b) Guidelines and Recommendations by Center for Substance
Abuse Treatment.--Section 507(b) of the Public Health Service
Act (42 U.S.C. 290bb(b)) is amended--
(1) in paragraph (13), by striking ``and'' at the end;
(2) in paragraph (14), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
``(15) in cooperation with the Secretary, implement and
disseminate, as appropriate, the recommendations in the
report entitled `Protecting Our Infants Act: Final Strategy'
issued by the Department of Health and Human Services in
2017; and''.
(c) Support of Partnerships by Center for Substance Abuse
Treatment.--Section 507(b) of the Public Health Service Act
(42 U.S.C. 290bb(b)), as amended by subsection (b), is
further amended by adding at the end the following:
``(16) in cooperation with relevant stakeholders, support
public-private partnerships to assist with education about,
and support with respect to, substance use disorder for
pregnant women and health care providers who treat pregnant
women and babies.''.
SEC. 1420. REPORT ON INVESTIGATIONS REGARDING PARITY IN
MENTAL HEALTH AND SUBSTANCE USE DISORDER
BENEFITS.
(a) In General.--Section 13003 of the 21st Century Cures
Act (Public Law 114-255) is amended--
(1) in subsection (a), by striking ``with findings of any
serious violation regarding'' and inserting ``concerning'';
and
(2) in subsection (b)(1)--
(A) by inserting ``complaints received and number of''
before ``closed''; and
(B) by inserting before the period ``, and, for each such
investigation closed, which agency conducted the
investigation, whether the health plan that is the subject of
the investigation is fully insured or not fully insured and a
summary of any coordination between the applicable State
regulators and the Department of Labor, the Department of
Health and Human Services, or the Department of the Treasury,
and references to any guidance provided by the agencies
addressing the category of violation committed''.
(b) Applicability.--The amendments made by subsection (a)
shall apply with respect to the second annual report required
under such section 13003 and each such annual report
thereafter.
Subtitle E--Prevention
SEC. 1501. STUDY ON PRESCRIBING LIMITS.
Not later than 2 years after the date of enactment of this
Act, the Secretary, in consultation with the Attorney
General, shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
impact of Federal and State laws and regulations that limit
the length, quantity, or dosage of opioid prescriptions. Such
report shall address--
(1) the impact of such limits on--
(A) the incidence and prevalence of overdose related to
prescription opioids;
(B) the incidence and prevalence of overdose related to
illicit opioids;
(C) the prevalence of opioid use disorders;
(D) medically appropriate use of, and access to, opioids,
including any impact on travel expenses and pain management
outcomes for patients, whether such limits are associated
with significantly higher rates of negative health outcomes,
including suicide, and whether the impact of such limits
differs based on the clinical indication for which opioids
are prescribed;
(2) whether such limits lead to a significant increase in
burden for prescribers of opioids or prescribers of
treatments for opioid use disorder, including any impact on
patient access to treatment, and whether any such burden is
mitigated by any factors such as electronic prescribing or
telemedicine; and
(3) the impact of such limits on diversion or misuse of any
controlled substance in schedule II, III, or IV of section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
SEC. 1502. PROGRAMS FOR HEALTH CARE WORKFORCE.
(a) Program for Education and Training in Pain Care.--
Section 759 of the Public Health Service Act (42 U.S.C. 294i)
is amended--
(1) in subsection (a), by striking ``hospices, and other
public and private entities'' and inserting ``hospices,
tribal health programs (as defined in section 4 of the Indian
Health Care Improvement Act), and other public and nonprofit
private entities'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking
``award may be made under subsection (a) only if the
applicant for the award agrees that the program carried out
with the award will include'' and inserting ``entity
receiving an award under this section shall develop a
comprehensive education and training plan that includes'';
(B) in paragraph (1)--
(i) by inserting ``preventing,'' after ``diagnosing,''; and
(ii) by inserting ``non-addictive medical products and non-
pharmacologic treatments and'' after ``including'';
(C) in paragraph (2)--
(i) by inserting ``Federal, State, and local'' after
``applicable''; and
(ii) by striking ``the degree to which'' and all that
follows through ``effective pain care'' and inserting
``opioids'';
(D) in paragraph (3), by inserting ``, integrated,
evidence-based pain management, and, as appropriate, non-
pharmacotherapy'' before the semicolon;
(E) in paragraph (4), by striking ``; and'' and inserting
``;''; and
(F) by striking paragraph (5) and inserting the following:
``(5) recent findings, developments, and advancements in
pain care research and the provision of pain care, which may
include non-addictive medical products and non-pharmacologic
treatments intended to treat pain; and
``(6) the dangers of opioid abuse and misuse, detection of
early warning signs of opioid use disorders (which may
include best practices related to screening for opioid use
disorders, training on screening, brief intervention, and
referral to treatment), and safe disposal options for
prescription medications (including such options provided by
law enforcement or other innovative deactivation
mechanisms).'';
(3) in subsection (d), by inserting ``prevention,'' after
``diagnosis,''; and
(4) in subsection (e), by striking ``2010 through 2012''
and inserting ``2019 through 2023''.
(b) Mental and Behavioral Health Education and Training
Program.--Section 756(a) of the Public Health Service Act (42
U.S.C. 294e-1(a)) is amended--
(1) in paragraph (1), by inserting ``, trauma,'' after
``focus on child and adolescent mental health''; and
(2) in paragraphs (2) and (3), by inserting ``trauma-
informed care and'' before ``substance use disorder
prevention and treatment services''.
SEC. 1503. EDUCATION AND AWARENESS CAMPAIGNS.
Section 102 of the Comprehensive Addiction and Recovery Act
of 2016 (Public Law 114-198) is amended--
(1) by amending subsection (a) to read as follows:
``(a) In General.--The Secretary of Health and Human
Services, acting through the Director of the Centers for
Disease Control and Prevention and in coordination with the
heads of other departments and agencies, shall advance
education and awareness regarding the risks related to misuse
and abuse of opioids, as appropriate, which may include
developing or improving existing programs, conducting
activities, and awarding grants that advance the education
and awareness of--
``(1) the public, including patients and consumers;
``(2) patients, consumers, and other appropriate members of
the public, regarding such risks related to unused opioids
and the dispensing options under section 309(f) of the
Controlled Substances Act, as applicable;
``(3) providers, which may include--
``(A) providing for continuing education on appropriate
prescribing practices;
``(B) education related to applicable State or local
prescriber limit laws, information on the use of non-
addictive alternatives for pain management, and the use of
overdose reversal drugs, as appropriate;
``(C) disseminating and improving the use of evidence-based
opioid prescribing guidelines across relevant health care
settings, as appropriate, and updating guidelines as
necessary;
``(D) implementing strategies, such as best practices, to
encourage and facilitate the use
[[Page S6079]]
of prescriber guidelines, in accordance with State and local
law;
``(E) disseminating information to providers about
prescribing options for controlled substances, including such
options under section 309(f) of the Controlled Substances
Act, as applicable; and
``(F) disseminating information, as appropriate, on the
National Pain Strategy developed by or in consultation with
the Assistant Secretary for Health; and
``(4) other appropriate entities.''; and
(2) in subsection (b)--
(A) by striking ``opioid abuse'' each place such term
appears and inserting ``opioid misuse and abuse''; and
(B) in paragraph (2), by striking ``safe disposal of
prescription medications and other'' and inserting ``non-
addictive treatment options, safe disposal options for
prescription medications, and other applicable''.
SEC. 1504. ENHANCED CONTROLLED SUBSTANCE OVERDOSES DATA
COLLECTION, ANALYSIS, AND DISSEMINATION.
Part J of title III of the Public Health Service Act is
amended by inserting after section 392 (42 U.S.C. 280b-1) the
following:
``SEC. 392A. ENHANCED CONTROLLED SUBSTANCE OVERDOSES DATA
COLLECTION, ANALYSIS, AND DISSEMINATION.
``(a) In General.--The Director of the Centers for Disease
Control and Prevention, using the authority provided to the
Director under section 392, may--
``(1) to the extent practicable, carry out and expand any
controlled substance overdose data collection, analysis, and
dissemination activity described in subsection (b);
``(2) provide training and technical assistance to States,
localities, and Indian Tribes for the purpose of carrying out
any such activity; and
``(3) award grants to States, localities, and Indian Tribes
for the purpose of carrying out any such activity.
``(b) Controlled Substance Overdose Data Collection and
Analysis Activities.--A controlled substance overdose data
collection, analysis, and dissemination activity described in
this subsection is any of the following activities:
``(1) Improving the timeliness of reporting aggregate data
to the public, including data on fatal and nonfatal
controlled substance overdoses.
``(2) Enhancing the comprehensiveness of controlled
substance overdose data by collecting information on such
overdoses from appropriate sources such as toxicology
reports, autopsy reports, death scene investigations, and
emergency department services.
``(3) Modernizing the system for coding causes of death
related to controlled substance overdoses to use an
electronic-based system.
``(4) Using data to help identify risk factors associated
with controlled substance overdoses, including the delivery
of certain health care services.
``(5) Supporting entities involved in reporting information
on controlled substance overdoses, such as coroners and
medical examiners, to improve accurate testing and
standardized reporting of causes and contributing factors of
such overdoses, and analysis of various opioid analogues to
controlled substance overdoses.
``(6) Working to enable and encourage the access, exchange,
and use of data regarding controlled substances overdoses
among data sources and entities.
``(c) Definitions.--In this section--
``(1) the term `controlled substance' has the meaning given
that term in section 102 of the Controlled Substances Act;
and
``(2) the term `Indian Tribe' has the meaning given the
term `Indian tribe' in section 4 of the Indian Self-
Determination and Education Assistance Act.''.
SEC. 1505. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
Part J of title III of the Public Health Service Act (42
U.S.C. 280b et seq.), as amended by section 504, is further
amended by inserting after section 392A the following:
``SEC. 392B. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
``(a) Prevention Activities.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention (referred to in this section as the
`Director'), using the authority provided to the Director
under section 392, may--
``(A) to the extent practicable, carry out and expand any
prevention activity described in paragraph (2);
``(B) provide training and technical assistance to States,
localities, and Indian Tribes to carry out any such activity;
and
``(C) award grants to States, localities, and Indian Tribes
for the purpose of carrying out any such activity.
``(2) Prevention activities.--A prevention activity
described in this paragraph is an activity to improve the
efficiency and use of a new or currently operating
prescription drug monitoring program, such as--
``(A) encouraging all authorized users (as specified by the
State or other entity) to register with and use the program;
``(B) enabling such users to access any data updates in as
close to real-time as practicable;
``(C) providing for a mechanism for the program to notify
authorized users of any potential misuse or abuse of
controlled substances and any detection of inappropriate
prescribing or dispensing practices relating to such
substances;
``(D) encouraging the analysis of prescription drug
monitoring data for purposes of providing de-identified,
aggregate reports based on such analysis to State public
health agencies, State alcohol and drug agencies, State
licensing boards, and other appropriate State agencies, as
permitted under applicable Federal and State law and the
policies of the prescription drug monitoring program and not
containing any protected health information, to prevent
inappropriate prescribing, drug diversion, or abuse and
misuse of controlled substances, and to facilitate better
coordination among agencies;
``(E) enhancing interoperability between the program and
any health information technology (including certified health
information technology), including by integrating program
data into such technology;
``(F) updating program capabilities to respond to
technological innovation for purposes of appropriately
addressing the occurrence and evolution of controlled
substance overdoses;
``(G) developing or enhancing data exchange with other
sources such as the Medicaid agency, the Medicare program,
pharmacy benefit managers, coroners' reports, and workers'
compensation data;
``(H) facilitating and encouraging data exchange between
the program and the prescription drug monitoring programs of
other States;
``(I) enhancing data collection and quality, including
improving patient matching and proactively monitoring data
quality; and
``(J) providing prescriber and dispenser practice tools,
including prescriber practice insight reports for
practitioners to review their prescribing patterns in
comparison to such patters of other practitioners in the
specialty.
``(b) Additional Grants.--The Director may award grants to
States, localities, and Indian Tribes--
``(1) to carry out innovative projects for grantees to
rapidly respond to controlled substance misuse, abuse, and
overdoses, including changes in patterns of controlled
substance use; and
``(2) for any other evidence-based activity for preventing
controlled substance misuse, abuse, and overdoses as the
Director determines appropriate.
``(c) Research.--The Director, in coordination with the
Assistant Secretary for Mental Health and Substance Use and
the National Mental Health and Substance Use Policy
Laboratory established under section 501A, as appropriate and
applicable, may conduct studies and evaluations to address
substance use disorders, including preventing substance use
disorders or other related topics the Director determines
appropriate.
``(d) Public and Prescriber Education.--Pursuant to section
102 of the Comprehensive Addiction and Recovery Act of 2016,
the Director may advance the education and awareness of
prescribers and the public regarding the risk of abuse and
misuse of prescription opioids.
``(e) Definitions.--In this section--
``(1) the term `controlled substance' has the meaning given
that term in section 102 of the Controlled Substances Act;
and
``(2) the term `Indian Tribe' has the meaning given the
term `Indian tribe' in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(f) Authorization of Appropriations.--For purposes of
carrying out this section, section 392A of this Act, and
section 102 of the Comprehensive Addiction and Recovery Act
of 2016, there is authorized to be appropriated $486,000,000
for each of fiscal years 2019 through 2024.''.
SEC. 1506. CDC SURVEILLANCE AND DATA COLLECTION FOR CHILD,
YOUTH, AND ADULT TRAUMA.
(a) Data Collection.--The Director of the Centers for
Disease Control and Prevention (referred to in this section
as the ``Director'') may, in cooperation with the States,
collect and report data on adverse childhood experiences
through the Behavioral Risk Factor Surveillance System, the
Youth Risk Behavior Surveillance System, and other relevant
public health surveys or questionnaires.
(b) Timing.--The collection of data under subsection (a)
may occur in fiscal year 2019 and every 2 years thereafter.
(c) Data From Rural Areas.--The Director shall encourage
each State that participates in collecting and reporting data
under subsection (a) to collect and report data from tribal
and rural areas within such State, in order to generate a
statistically reliable representation of such areas.
(d) Data From Tribal Areas.--The Director may, in
cooperation with Indian Tribes and pursuant to a written
request from an Indian Tribe, provide technical assistance to
such Indian Tribe to collect and report data on adverse
childhood experiences through the Behavioral Risk Factor
Surveillance System, the Youth Risk Behavior Surveillance
System, or another relevant public health survey or
questionnaire.
(e) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated such sums as
may be necessary for the period of fiscal years 2019 through
2021.
SEC. 1507. REAUTHORIZATION OF NASPER.
Section 399O of the Public Health Service Act (42 U.S.C.
280g-3) is amended--
(1) in subsection (a)--
(A) in paragraph (1), in the matter preceding subparagraph
(A), by striking ``in consultation with the Administrator of
the Substance Abuse and Mental Health Services Administration
and Director of the Centers
[[Page S6080]]
for Disease Control and Prevention'' and inserting ``in
coordination with the Director of the Centers for Disease
Control and the heads of other departments and agencies as
appropriate''; and
(B) by adding at the end the following:
``(4) States and local governments.--
``(A) In general.--In the case of a State that does not
have a prescription drug monitoring program, a county or
other unit of local government within the State that has a
prescription drug monitoring program shall be treated as a
State for purposes of this section, including for purposes of
eligibility for grants under paragraph (1).
``(B) Plan for interoperability.--For purposes of meeting
the interoperability requirements under subsection (c)(3), a
county or other unit of local government shall submit a plan
outlining the methods such county or unit of local government
will use to ensure the capability of data sharing with other
counties and units of local government within the State and
with other States, as applicable.'';
(2) in subsection (c)--
(A) in paragraph (1)(A)(iii)--
(i) by inserting ``as such standards become available,''
after ``interoperability standards,''; and
(ii) by striking ``generated or identified by the Secretary
or his or her designee'' and inserting ``recognized by the
Office of the National Coordinator for Health Information
Technology''; and
(B) in paragraph (3)(A), by inserting ``including
electronic health records,'' after ``technology systems,'';
(3) in subsection (d)(1), by striking ``not later than 1
week after the date of such dispensing'' and inserting ``in
as close to real time as practicable'';
(4) in subsection (f)--
(A) in paragraph (1)(D), by striking ``medicaid'' and
inserting ``Medicaid''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``and'' at the end;
(ii) in subparagraph (B), by striking the period and
inserting a semicolon; and
(iii) by adding at the end the following:
``(C) may conduct analyses of controlled substance program
data for purposes of providing appropriate State agencies
with aggregate reports based on such analyses in as close to
real-time as practicable, regarding prescription patterns
flagged as potentially presenting a risk of misuse, abuse,
addiction, overdose, and other aggregate information, as
appropriate and in compliance with applicable Federal and
State laws and provided that such reports shall not include
protected health information; and
``(D) may access information about prescriptions, such as
claims data, to ensure that such prescribing and dispensing
history is updated in as close to real-time as practicable,
in compliance with applicable Federal and State laws and
provided that such information shall not include protected
health information.'';
(5) in subsection (i), by inserting ``, in collaboration
with the National Coordinator for Health Information
Technology and the Director of the National Institute of
Standards and Technology,'' after ``The Secretary''; and
(6) in subsection (n), by striking ``2021'' and inserting
``2026''.
SEC. 1508. JESSIE'S LAW.
(a) Best Practices.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, in consultation with
appropriate stakeholders, including a patient with a history
of opioid use disorder, an expert in electronic health
records, an expert in the confidentiality of patient health
information and records, and a health care provider, shall
identify or facilitate the development of best practices
regarding--
(A) the circumstances under which information that a
patient has provided to a health care provider regarding such
patient's history of opioid use disorder should, only at the
patient's request, be prominently displayed in the medical
records (including electronic health records) of such
patient;
(B) what constitutes the patient's request for the purpose
described in subparagraph (A); and
(C) the process and methods by which the information should
be so displayed.
(2) Dissemination.--The Secretary shall disseminate the
best practices developed under paragraph (1) to health care
providers and State agencies.
(b) Requirements.--In identifying or facilitating the
development of best practices under subsection (a), as
applicable, the Secretary, in consultation with appropriate
stakeholders, shall consider the following:
(1) The potential for addiction relapse or overdose,
including overdose death, when opioid medications are
prescribed to a patient recovering from opioid use disorder.
(2) The benefits of displaying information about a
patient's opioid use disorder history in a manner similar to
other potentially lethal medical concerns, including drug
allergies and contraindications.
(3) The importance of prominently displaying information
about a patient's opioid use disorder when a physician or
medical professional is prescribing medication, including
methods for avoiding alert fatigue in providers.
(4) The importance of a variety of appropriate medical
professionals, including physicians, nurses, and pharmacists,
having access to information described in this section when
prescribing or dispensing opioid medication, consistent with
Federal and State laws and regulations.
(5) The importance of protecting patient privacy, including
the requirements related to consent for disclosure of
substance use disorder information under all applicable laws
and regulations.
(6) All applicable Federal and State laws and regulations.
SEC. 1509. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING
PROGRAMS FOR SUBSTANCE USE DISORDER PATIENT
RECORDS.
(a) Initial Programs and Materials.--Not later than 1 year
after the date of the enactment of this Act, the Secretary,
in consultation with appropriate experts, shall identify the
following model programs and materials (or if no such
programs or materials exist, recognize private or public
entities to develop and disseminate such programs and
materials):
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, psychologists, counselors, therapists, nurse
practitioners, physician assistants, behavioral health
facilities and clinics, care managers, and hospitals,
including individuals such as general counsels or regulatory
compliance staff who are responsible for establishing
provider privacy policies) concerning the permitted uses and
disclosures, consistent with the standards and regulations
governing the privacy and security of substance use disorder
patient records promulgated by the Secretary under section
543 of the Public Health Service Act (42 U.S.C. 290dd-2) for
the confidentiality of patient records.
(2) Model programs and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations described in
paragraph (1).
(b) Requirements.--The model programs and materials
described in paragraphs (1) and (2) of subsection (a) shall
address circumstances under which disclosure of substance use
disorder patient records is needed to--
(1) facilitate communication between substance use disorder
treatment providers and other health care providers to
promote and provide the best possible integrated care;
(2) avoid inappropriate prescribing that can lead to
dangerous drug interactions, overdose, or relapse; and
(3) notify and involve families and caregivers when
individuals experience an overdose.
(c) Periodic Updates.--The Secretary shall--
(1) periodically review and update the model program and
materials identified or developed under subsection (a); and
(2) disseminate such updated programs and materials to the
individuals described in subsection (a)(1).
(d) Input of Certain Entities.--In identifying, reviewing,
or updating the model programs and materials under this
section, the Secretary shall solicit the input of relevant
stakeholders.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, such sums as
may be necessary for each of fiscal years 2019 through 2023.
SEC. 1510. COMMUNICATION WITH FAMILIES DURING EMERGENCIES.
(a) Promoting Awareness of Authorized Disclosures During
Emergencies.--The Secretary shall annually notify health care
providers regarding permitted disclosures during emergencies,
including overdoses, of certain health information to
families and caregivers under Federal health care privacy
laws and regulations.
(b) Use of Material.--For the purposes of carrying out
subsection (a), the Secretary may use material produced under
section 1509 of this Act or under section 11004 of the 21st
Century Cures Act (42 U.S.C. 1320d-2 note).
SEC. 1511. PRENATAL AND POSTNATAL HEALTH.
Section 317L of the Public Health Service Act (42 U.S.C.
247b-13) is amended--
(1) in subsection (a)--
(A) by amending paragraph (1) to read as follows:
``(1) to collect, analyze, and make available data on
prenatal smoking and alcohol and substance abuse and misuse,
including--
``(A) data on--
``(i) the incidence, prevalence, and implications of such
activities; and
``(ii) the incidence and prevalence of implications and
outcomes, including neonatal abstinence syndrome and other
maternal and child health outcomes associated with such
activities; and
``(B) to inform such analysis, additional information or
data on family health history, medication exposures during
pregnancy, demographic information, such as race, ethnicity,
geographic location, and family history, and other relevant
information, as appropriate;'';
(B) in paragraph (2)--
(i) by striking ``prevention of'' and inserting
``prevention and long-term outcomes associated with''; and
(ii) by striking ``illegal drug use'' and inserting
``substance abuse and misuse'';
(C) in paragraph (3), by striking ``and cessation programs;
and'' and inserting ``, treatment, and cessation programs;'';
(D) in paragraph (4), by striking ``illegal drug use.'' and
inserting ``substance abuse and misuse; and''; and
[[Page S6081]]
(E) by adding at the end the following:
``(5) to issue public reports on the analysis of data
described in paragraph (1), including analysis of--
``(A) long-term outcomes of children affected by neonatal
abstinence syndrome;
``(B) health outcomes associated with prenatal smoking,
alcohol, and substance abuse and misuse; and
``(C) relevant studies, evaluations, or information the
Secretary determines to be appropriate.'';
(2) in subsection (b), by inserting ``tribal entities,''
after ``local governments,'';
(3) by redesignating subsection (c) as subsection (d);
(4) by inserting after subsection (b) the following:
``(c) Coordinating Activities.--To carry out this section,
the Secretary may--
``(1) provide technical and consultative assistance to
entities receiving grants under subsection (b);
``(2) ensure a pathway for data sharing between States,
tribal entities, and the Centers for Disease Control and
Prevention;
``(3) ensure data collection under this section is
consistent with applicable State, Federal, and Tribal privacy
laws; and
``(4) coordinate with the National Coordinator for Health
Information Technology, as appropriate, to assist States and
Tribes in implementing systems that use standards recognized
by such National Coordinator, as such recognized standards
are available, in order to facilitate interoperability
between such systems and health information technology
systems, including certified health information
technology.''; and
(5) in subsection (d), as so redesignated, by striking
``2001 through 2005'' and inserting ``2019 through 2023''.
SEC. 1512. SURVEILLANCE AND EDUCATION REGARDING INFECTIONS
ASSOCIATED WITH ILLICIT DRUG USE AND OTHER RISK
FACTORS.
Section 317N of the Public Health Service Act (42 U.S.C.
247b-15) is amended--
(1) by amending the section heading to read as follows:
``surveillance and education regarding infections associated
with illicit drug use and other risk factors'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by inserting
``activities'' before the colon;
(B) in paragraph (1)--
(i) by inserting ``or maintaining'' after ``implementing'';
(ii) by striking ``hepatitis C virus infection (in this
section referred to as `HCV infection')'' and inserting
``infections commonly associated with illicit drug use, which
may include viral hepatitis, human immunodeficiency virus,
and infective endocarditis,''; and
(iii) by striking ``such infection'' and all that follows
through the period at the end and inserting ``such
infections, which may include the reporting of cases of such
infections.'';
(C) in paragraph (2), by striking ``HCV infection'' and all
that follows through the period at the end and inserting
``infections as a result of illicit drug use, receiving blood
transfusions prior to July 1992, or other risk factors.'';
(D) in paragraphs (4) and (5), by striking ``HCV
infection'' each place such term appears and inserting
``infections described in paragraph (1)''; and
(E) in paragraph (5), by striking ``pediatricians and other
primary care physicians, and obstetricians and
gynecologists'' and inserting ``substance use disorder
treatment providers, pediatricians, other primary care
providers, and obstetrician-gynecologists'';
(3) in subsection (b)--
(A) by striking ``directly and'' and inserting ``directly
or''; and
(B) by striking ``hepatitis C,'' and all that follows
through the period at the end and inserting ``infections
described in subsection (a)(1).''; and
(4) in subsection (c), by striking ``such sums as may be
necessary for each of the fiscal years 2001 through 2005''
and inserting ``$40,000,000 for each of fiscal years 2019
through 2023''.
SEC. 1513. TASK FORCE TO DEVELOP BEST PRACTICES FOR TRAUMA-
INFORMED IDENTIFICATION, REFERRAL, AND SUPPORT.
(a) Establishment.--There is established a task force, to
be known as the Interagency Task Force on Trauma-Informed
Care (in this section referred to as the ``task force'') that
shall identify, evaluate, and make recommendations regarding
best practices with respect to children and youth, and their
families as appropriate, who have experienced or are at risk
of experiencing trauma.
(b) Membership.--
(1) Composition.--The task force shall be composed of the
heads of the following Federal departments and agencies, or
their designees:
(A) The Centers for Medicare & Medicaid Services.
(B) The Substance Abuse and Mental Health Services
Administration.
(C) The Agency for Healthcare Research and Quality.
(D) The Centers for Disease Control and Prevention.
(E) The Indian Health Service.
(F) The Department of Veterans Affairs.
(G) The National Institutes of Health.
(H) The Food and Drug Administration.
(I) The Health Resources and Services Administration.
(J) The Department of Defense.
(K) The Office of Minority Health.
(L) The Administration for Children and Families.
(M) The Office of the Assistant Secretary for Planning and
Evaluation.
(N) The Office for Civil Rights of the Department of Health
and Human Services.
(O) The Office of Juvenile Justice and Delinquency
Prevention of the Department of Justice.
(P) The Office of Community Oriented Policing Services of
the Department of Justice.
(Q) The Office on Violence Against Women of the Department
of Justice.
(R) The National Center for Education Evaluation and
Regional Assistance of the Department of Education.
(S) The National Center for Special Education Research of
the Institute of Education Science.
(T) The Office of Elementary and Secondary Education of the
Department of Education.
(U) The Office for Civil Rights of the Department of
Education.
(V) The Office of Special Education and Rehabilitative
Services of the Department of Education.
(W) The Bureau of Indian Affairs of the Department of the
Interior.
(X) The Veterans Health Administration of the Department of
Veterans Affairs.
(Y) The Office of Special Needs Assistance Programs of the
Department of Housing and Urban Development.
(Z) The Office of Head Start of the Administration for
Children and Families.
(AA) The Children's Bureau of the Administration for
Children and Families.
(BB) The Bureau of Indian Education of the Department of
the Interior.
(CC) Such other Federal agencies as the Secretaries
determine to be appropriate.
(2) Date of appointments.--The heads of Federal departments
and agencies shall appoint the corresponding members of the
task force not later than 6 months after the date of
enactment of this Act.
(3) Chairperson.--The task force shall be chaired by the
Assistant Secretary for Mental Health and Substance Use.
(c) Task Force Duties.--The task force shall--
(1) solicit input from stakeholders, including frontline
service providers, educators, mental health professionals,
researchers, experts in infant, child, and youth trauma,
child welfare professionals, and the public, in order to
inform the activities under paragraph (2); and
(2) identify, evaluate, make recommendations, and update
such recommendations not less than annually, to the general
public, the Secretary of Education, the Secretary of Health
and Human Services, the Secretary of Labor, the Secretary of
the Interior, the Attorney General, and other relevant
cabinet Secretaries, and Congress regarding--
(A) a set of evidence-based, evidence-informed, and
promising best practices with respect to--
(i) the identification of infants, children and youth, and
their families as appropriate, who have experienced or are at
risk of experiencing trauma; and
(ii) the expeditious referral to and implementation of
trauma-informed practices and supports that prevent and
mitigate the effects of trauma;
(B) a national strategy on how the task force and member
agencies will collaborate, prioritize options for, and
implement a coordinated approach which may include data
sharing and the awarding of grants that support infants,
children, and youth, and their families as appropriate, who
have experienced or are at risk of experiencing trauma; and
(C) existing Federal authorities at the Department of
Education, Department of Health and Human Services,
Department of Justice, Department of Labor, Department of the
Interior, and other relevant agencies, and specific Federal
grant programs to disseminate best practices on, provide
training in, or deliver services through, trauma-informed
practices, and disseminate such information--
(i) in writing to relevant program offices at such agencies
to encourage grant applicants in writing to use such funds,
where appropriate, for trauma-informed practices; and
(ii) to the general public through the internet website of
the task force.
(d) Best Practices.--In identifying, evaluating, and
recommending the set of best practices under subsection (c),
the task force shall--
(1) include guidelines for providing professional
development for front-line services providers, including
school personnel, early childhood education program
providers, providers from child- or youth-serving
organizations, housing and homeless providers, primary and
behavioral health care providers, child welfare and social
services providers, juvenile and family court personnel,
health care providers, individuals who are mandatory
reporters of child abuse or neglect, trained nonclinical
providers (including peer mentors and clergy), and first
responders, in--
(A) understanding and identifying early signs and risk
factors of trauma in infants, children, and youth, and their
families as appropriate, including through screening
processes;
(B) providing practices to prevent and mitigate the impact
of trauma, including by fostering safe and stable
environments and relationships; and
[[Page S6082]]
(C) developing and implementing policies, procedures, or
systems that--
(i) are designed to quickly refer infants, children, youth,
and their families as appropriate, who have experienced or
are at risk of experiencing trauma to the appropriate trauma-
informed screening and support, including age-appropriate
treatment, and to ensure such infants, children, youth, and
family members receive such support;
(ii) utilize and develop partnerships with early childhood
education programs, local social services organizations, such
as organizations serving youth, and clinical mental health or
health care service providers with expertise in providing
support services (including age-appropriate trauma-informed
and evidence-based treatment) aimed at preventing or
mitigating the effects of trauma;
(iii) educate children and youth to--
(I) understand and identify the signs, effects, or symptoms
of trauma; and
(II) build the resilience and coping skills to mitigate the
effects of experiencing trauma;
(iv) promote and support multi-generational practices that
assist parents, foster parents, and kinship and other
caregivers in accessing resources related to, and developing
environments conducive to, the prevention and mitigation of
trauma; and
(v) collect and utilize data from screenings, referrals, or
the provision of services and supports to evaluate and
improve processes for trauma-informed support and outcomes
that are culturally sensitive, linguistically appropriate,
and specific to age ranges and sex, as applicable; and
(2) recommend best practices that are designed to avoid
unwarranted custody loss or criminal penalties for parents or
guardians in connection with infants, children, and youth who
have experienced or are at risk of experiencing trauma.
(e) Operating Plan.--Not later than 1 year after the date
of enactment of this Act, the task force shall hold the first
meeting. Not later than 2 years after such date of enactment,
the task force shall submit to the Secretary of Education,
Secretary of Health and Human Services, Secretary of Labor,
Secretary of the Interior, the Attorney General, and Congress
an operating plan for carrying out the activities of the task
force described in subsection (c)(2). Such operating plan
shall include--
(1) a list of specific activities that the task force plans
to carry out for purposes of carrying out duties described in
subsection (c)(2), which may include public engagement;
(2) a plan for carrying out the activities under subsection
(c)(2);
(3) a list of members of the task force and other
individuals who are not members of the task force that may be
consulted to carry out such activities;
(4) an explanation of Federal agency involvement and
coordination needed to carry out such activities, including
any statutory or regulatory barriers to such coordination;
(5) a budget for carrying out such activities; and
(6) other information that the task force determines
appropriate.
(f) Final Report.--Not later than 3 years after the date of
the first meeting of the task force, the task force shall
submit to the general public, Secretary of Education,
Secretary of Health and Human Services, Secretary of Labor,
Secretary of the Interior, the Attorney General, and other
relevant cabinet Secretaries, and Congress, a final report
containing all of the findings and recommendations required
under this section.
(g) Definition.--In this section, the term ``early
childhood education program'' has the meaning given such term
in section 103 of the Higher Education Act of 1965 (20 U.S.C.
1003).
(h) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated such sums as
may be necessary for each of fiscal years 2019 through 2022.
(i) Sunset.--The task force shall on the date that is 60
days after the submission of the final report under
subsection (f), but not later than September 30, 2022.
SEC. 1514. GRANTS TO IMPROVE TRAUMA SUPPORT SERVICES AND
MENTAL HEALTH CARE FOR CHILDREN AND YOUTH IN
EDUCATIONAL SETTINGS.
(a) Grants, Contracts, and Cooperative Agreements
Authorized.--The Secretary, in coordination with the
Assistant Secretary for Mental Health and Substance Use, is
authorized to award grants to, or enter into contracts or
cooperative agreements with, State educational agencies,
local educational agencies, Head Start agencies (including
Early Head Start agencies), State or local agencies that
administer public preschool programs, Indian Tribes or their
tribal educational agencies, a school operated by the Bureau
of Indian Education, a Regional Corporation (as defined in
section 3 of the Alaska Native Claims Settlement Act (43
U.S.C. 1602)), or a Native Hawaiian educational organization
(as defined in section 6207 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7517)), for the purpose of
increasing student access to evidence-based trauma support
services and mental health care by developing innovative
initiatives, activities, or programs to link local school
systems with local trauma-informed support and mental health
systems, including those under the Indian Health Service.
(b) Duration.--With respect to a grant, contract, or
cooperative agreement awarded or entered into under this
section, the period during which payments under such grant,
contract or agreement are made to the recipient may not
exceed 4 years.
(c) Use of Funds.--An entity that receives a grant,
contract, or cooperative agreement under this section shall
use amounts made available through such grant, contract, or
cooperative agreement for evidence-based activities, which
shall include any of the following:
(1) Collaborative efforts between school-based service
systems and trauma-informed support and mental health service
systems to provide, develop, or improve prevention,
screening, referral, and treatment and support services to
students, such as by providing universal trauma screenings to
identify students in need of specialized support.
(2) To implement schoolwide multi-tiered positive
behavioral interventions and supports, or other trauma-
informed models of support.
(3) To provide professional development to teachers,
teacher assistants, school leaders, specialized instructional
support personnel, and mental health professionals that--
(A) fosters safe and stable learning environments that
prevent and mitigate the effects of trauma, including through
social and emotional learning;
(B) improves school capacity to identify, refer, and
provide services to students in need of trauma support or
behavioral health services; or
(C) reflects the best practices developed by the
Interagency Task Force on Trauma-Informed Care established
under section 513.
(4) To create or enhance services at a full-service
community school that focuses on trauma-informed supports,
which may include establishing a school-site advisory team,
managing, coordinating, or delivering pipeline services,
hiring a full-time site coordinator, or other activities
consistent with section 4625 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7275).
(5) Engaging families and communities in efforts to
increase awareness of child and youth trauma, which may
include sharing best practices with law enforcement regarding
trauma-informed care and working with mental health
professionals to provide interventions, as well as longer
term coordinated care within the community for children and
youth who have experienced trauma and their families.
(6) To provide technical assistance to school systems and
mental health agencies.
(7) To evaluate the effectiveness of the program carried
out under this section in increasing student access to
evidence-based trauma support services and mental health
care.
(d) Applications.--To be eligible to receive a grant,
contract, or cooperative agreement under this section, an
entity described in subsection (a) shall submit an
application to the Secretary at such time, in such manner,
and containing such information as the Secretary may
reasonably require, which shall include the following:
(1) A description of the innovative initiatives,
activities, or programs to be funded under the grant,
contract, or cooperative agreement, including how such
program will increase access to evidence-based trauma support
services and mental health care for students, and, as
applicable, the families of such students.
(2) A description of how the program will provide
linguistically appropriate and culturally competent services.
(3) A description of how the program will support students
and the school in improving the school climate in order to
support an environment conducive to learning.
(4) An assurance that--
(A) persons providing services under the grant, contract,
or cooperative agreement are adequately trained to provide
such services; and
(B) teachers, school leaders, administrators, specialized
instructional support personnel, representatives of local
Indian Tribes or tribal organizations as appropriate, other
school personnel, and parents or guardians of students
participating in services under this section will be engaged
and involved in the design and implementation of the
services.
(5) A description of how the applicant will support and
integrate existing school-based services with the program in
order to provide mental health services for students, as
appropriate.
(e) Interagency Agreements.--
(1) Designation of lead agency.--A recipient of a grant,
contract, or cooperative agreement under this section shall
designate a lead agency to direct the establishment of an
interagency agreement among local educational agencies,
agencies responsible for early childhood education programs,
juvenile justice authorities, mental health agencies, child
welfare agencies, and other relevant entities in the State or
Indian Tribe, in collaboration with local entities.
(2) Contents.--The interagency agreement shall ensure the
provision of the services described in subsection (c),
specifying with respect to each agency, authority, or
entity--
(A) the financial responsibility for the services;
(B) the conditions and terms of responsibility for the
services, including quality, accountability, and coordination
of the services; and
(C) the conditions and terms of reimbursement among the
agencies, authorities, or entities that are parties to the
interagency agreement, including procedures for dispute
resolution.
(f) Evaluation.--The Secretary shall reserve not to exceed
3 percent of the funds
[[Page S6083]]
made available under subsection (l) for each fiscal year to--
(1) conduct a rigorous, independent evaluation of the
activities funded under this section; and
(2) disseminate and promote the utilization of evidence-
based practices regarding trauma support services and mental
health care.
(g) Distribution of Awards.--The Secretary shall ensure
that grants, contracts, and cooperative agreements awarded or
entered into under this section are equitably distributed
among the geographical regions of the United States and among
tribal, urban, suburban, and rural populations.
(h) Rule of Construction.--Nothing in this section shall be
construed--
(1) to prohibit an entity involved with a program carried
out under this section from reporting a crime that is
committed by a student to appropriate authorities; or
(2) to prevent Federal, State, and tribal law enforcement
and judicial authorities from exercising their
responsibilities with regard to the application of Federal,
tribal, and State law to crimes committed by a student.
(i) Supplement, Not Supplant.--Any services provided
through programs carried out under this section shall
supplement, and not supplant, existing mental health
services, including any special education and related
services provided under the Individuals with Disabilities
Education Act (20 U.S.C. 1400 et seq.).
(j) Consultation With Indian Tribes.--In carrying out
subsection (a), the Secretary shall, in a timely manner,
meaningfully consult, engage, and cooperate with Indian
Tribes and their representatives to ensure notice of
eligibility.
(k) Definitions.--In this section:
(1) Elementary or secondary school.--The term ``elementary
or secondary school'' means a public elementary and secondary
school as such term is defined in section 8101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801).
(2) Evidence-based.--The term ``evidence-based'' has the
meaning given such term in section 8101(21)(A)(i) of the
Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801(21)(A)(i)).
(3) Native hawaiian educational organization.--The term
``Native Hawaiian educational organization'' has the meaning
given such term in section 6207 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7517).
(4) Pipeline services.--The term ``pipeline services'' has
the meaning given such term in section 4622 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 7517).
(5) School leader.--The term ``school leader'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(6) Secretary.--The term ``Secretary'' means the Secretary
of Education.
(7) Specialized instructional support personnel.--The term
``specialized instructional support personnel'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(l) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, such sums as
may be necessary for each of fiscal years 2019 through 2023.
SEC. 1515. NATIONAL CHILD TRAUMATIC STRESS INITIATIVE.
Section 582(j) of the Public Health Service Act (42 U.S.C.
290hh-1(j)) (relating to grants to address the problems of
persons who experience violence-related stress) is amended by
striking ``$46,887,000 for each of fiscal years 2018 through
2022'' and inserting ``$53,887,000 for each of fiscal years
2019 through 2023''.
SEC. 1516. NATIONAL MILESTONES TO MEASURE SUCCESS IN
CURTAILING THE OPIOID CRISIS.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in consultation with
the Administrator of the Drug Enforcement Administration and
the Director of the Office of National Drug Control Policy,
shall develop or identify existing national indicators
(referred to in this section as the ``national milestones'')
to measure success in curtailing the opioid crisis, with the
goal of significantly reversing the incidence and prevalence
of opioid misuse and abuse, and opioid-related morbidity and
mortality in the United States within 5 years of such date of
enactment.
(b) National Milestones to End the Opioid Crisis.--The
national milestones under subsection (a) shall include the
following:
(1) Not fewer than 10 indicators or metrics to accurately
and expediently measure progress in meeting the goal
described in subsection (a), which shall, as appropriate,
include, indicators or metrics related to--
(A) the number of fatal and non-fatal opioid overdoses;
(B) the number of emergency room visits related to opioid
misuse and abuse;
(C) the number of individuals in sustained recovery from
opioid use disorder;
(D) the number of infections associated with illicit drug
use, such as HIV, viral hepatitis, and infective
endocarditis, and available capacity for treating such
infections;
(E) the number of providers prescribing medication assisted
treatment for opioid use disorders, including in primary care
settings, community health centers, jails, and prisons;
(F) the number of individuals receiving treatment for
opioid use disorder; and
(G) additional indicators or metrics, as appropriate, such
as metrics pertaining to specific populations, including
women and children, American Indians and Alaskan Natives,
individuals living in rural and non-urban areas, and justice-
involved populations, that would further clarify the progress
made in addressing the opioid misuse and abuse crisis.
(2) A reasonable goal, such as a percentage decrease or
other specified metric, that signifies progress in meeting
the goal described in subsection (a), and annual targets to
help achieve that goal.
(c) Consideration of Other Substance Use Disorders.--In
developing the national milestones under subsection (b), the
Secretary shall, as appropriate, consider other substance use
disorders in addition to opioid use disorder.
(d) Extension of Period.--If the Secretary determines that
the goal described in subsection (a) will not be achieved
with respect to any indicator or metric established under
subsection (b)(2) within 5 years of the date of enactment of
this Act, the Secretary may extend the timeline for meeting
such goal with respect to that indicator or metric. The
Secretary shall include with any such extension a rationale
for why additional time is needed and information on whether
significant changes are needed in order to achieve such goal
with respect to the indicator or metric.
(e) Annual Status Update.--Not later than one year after
the enactment of this Act, the Secretary shall make available
on the internet website of the Department of Health and Human
Services, and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, an update on
the progress, including expected progress in the subsequent
year, in achieving the goals detailed in the national
milestones. Each such update shall include the progress made
in the first year or since the previous report, as
applicable, in meeting each indicator or metric in the
national milestones.
TITLE II--FINANCE
SEC. 2001. SHORT TITLE.
This title may be cited as the ``Helping to End Addiction
and Lessen Substance Use Disorders Act of 2018'' or the
``HEAL Act of 2018''.
Subtitle A--Medicare
SEC. 2101. MEDICARE OPIOID SAFETY EDUCATION.
(a) In General.--Section 1804 of the Social Security Act
(42 U.S.C. 1395b-2) is amended by adding at the end the
following new subsection:
``(d) The notice provided under subsection (a) shall
include--
``(1) references to educational resources regarding opioid
use and pain management;
``(2) a description of categories of alternative, non-
opioid pain management treatments covered under this title;
and
``(3) a suggestion for the beneficiary to talk to a
physician regarding opioid use and pain management.''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply to notices distributed prior to each Medicare
open enrollment period beginning after January 1, 2019.
SEC. 2102. EXPANDING THE USE OF TELEHEALTH SERVICES FOR THE
TREATMENT OF OPIOID USE DISORDER AND OTHER
SUBSTANCE USE DISORDERS.
(a) In General.--Section 1834(m) of the Social Security Act
(42 U.S.C. 1395m(m)) is amended--
(1) in paragraph (2)(B)--
(A) in clause (i), in the matter preceding subclause (I),
by striking ``clause (ii)'' and inserting ``clause (ii) and
paragraph (6)(C)''; and
(B) in clause (ii), in the heading, by striking ``for home
dialysis therapy'';
(2) in paragraph (4)(C)--
(A) in clause (i), by striking ``paragraph (6)'' and
inserting ``paragraphs (5), (6), and (7)''; and
(B) in clause (ii)(X), by inserting ``or telehealth
services described in paragraph (7)'' before the period at
the end; and
(3) by adding at the end the following new paragraph:
``(7) Treatment of substance use disorder services
furnished through telehealth.--The geographic requirements
described in paragraph (4)(C)(i) shall not apply with respect
to telehealth services furnished on or after January 1, 2019,
to an eligible telehealth individual with a substance use
disorder diagnosis for purposes of treatment of such
disorder, as determined by the Secretary, at an originating
site described in paragraph (4)(C)(ii) (other than an
originating site described in subclause (IX) of such
paragraph).''.
(b) Implementation.--The Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
may implement the amendments made by this section by interim
final rule.
(c) Report.--Not later than 5 years after the date of the
enactment of this Act, the Secretary shall submit to Congress
a report on the impact of the implementation of the
amendments made by this section with respect to telehealth
services under section 1834(m) of the Social Security Act (42
U.S.C. 1395m(m)) on--
(1) the utilization of health care items and services under
title XVIII of such Act (42 U.S.C. 1395 et seq.) related to
substance use disorders, including emergency department
visits; and
[[Page S6084]]
(2) health outcomes related to substance use disorders,
such as opioid overdose deaths.
SEC. 2103. COMPREHENSIVE SCREENINGS FOR SENIORS.
(a) Initial Preventive Physical Examination.--Section
1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is
amended--
(1) in paragraph (1)--
(A) by striking ``paragraph (2) and'' and inserting
``paragraph (2),''; and
(B) by inserting ``and the furnishing of a review of any
current opioid prescriptions (as defined in paragraph (4)),''
after ``upon the agreement with the individual,''; and
(2) in paragraph (2)--
(A) by redesignating subparagraph (N) as subparagraph (O);
and
(B) by inserting after subparagraph (M) the following new
subparagraph:
``(N) Screening for potential substance use disorders.'';
and
(3) by adding at the end the following new paragraph:
``(4) For purposes of paragraph (1), the term `a review of
any current opioid prescriptions' means, with respect to an
individual determined to have a current prescription for
opioids--
``(A) a review of the potential risk factors to the
individual for opioid use disorder;
``(B) an evaluation of the individual's severity of pain
and current treatment plan;
``(C) the provision of information on non-opioid treatment
options; and
``(D) a referral to a pain management specialist, as
appropriate.''.
(b) Annual Wellness Visit.--Section 1861(hhh)(2) of the
Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended--
(1) by redesignating subparagraph (G) as subparagraph (I);
and
(2) by inserting after subparagraph (F) the following new
subparagraphs:
``(G) Screening for potential substance use disorders and
referral for treatment as appropriate.
``(H) The furnishing of a review of any current opioid
prescriptions (as defined in subsection (ww)(4)).''.
(c) Effective Date.--The amendments made by this section
shall apply to examinations and visits furnished on or after
January 1, 2019.
SEC. 2104. EVERY PRESCRIPTION CONVEYED SECURELY.
(a) In General.--Section 1860D-4(e) of the Social Security
Act (42 U.S.C. 1395w-104(e)) is amended by adding at the end
the following:
``(7) Requirement of e-prescribing for controlled
substances.--
``(A) In general.--Subject to subparagraph (B), a
prescription for a covered part D drug under a prescription
drug plan (or under an MA-PD plan) for a schedule II, III,
IV, or V controlled substance shall be transmitted by a
health care practitioner electronically in accordance with an
electronic prescription drug program that meets the
requirements of paragraph (2).
``(B) Exception for certain circumstances.--The Secretary
shall, through rulemaking, specify circumstances and
processes by which the Secretary may waive the requirement
under subparagraph (A), with respect to a covered part D
drug, including in the case of--
``(i) a prescription issued when the practitioner and
dispensing pharmacy are the same entity;
``(ii) a prescription issued that cannot be transmitted
electronically under the most recently implemented version of
the National Council for Prescription Drug Programs SCRIPT
Standard;
``(iii) a prescription issued by a practitioner who
received a waiver or a renewal thereof for a period of time
as determined by the Secretary, not to exceed one year, from
the requirement to use electronic prescribing due to
demonstrated economic hardship, technological limitations
that are not reasonably within the control of the
practitioner, or other exceptional circumstance demonstrated
by the practitioner;
``(iv) a prescription issued by a practitioner under
circumstances in which, notwithstanding the practitioner's
ability to submit a prescription electronically as required
by this subsection, such 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 involved;
``(v) a prescription issued by a practitioner prescribing a
drug under a research protocol;
``(vi) a prescription issued by a practitioner for a drug
for which the Food and Drug Administration requires a
prescription to contain elements that are not able to be
included in electronic prescribing such as, a drug with risk
evaluation and mitigation strategies that include elements to
assure safe use;
``(vii) a prescription issued by a practitioner--
``(I) for an individual who receives hospice care under
this title; and
``(II) that is not covered under the hospice benefit under
this title; and
``(viii) a prescription issued by a practitioner for an
individual who is--
``(I) a resident of a nursing facility (as defined in
section 1919(a)); and
``(II) dually eligible for benefits under this title and
title XIX.
``(C) Dispensing.--(i) Nothing in this paragraph shall be
construed as requiring a sponsor of a prescription drug plan
under this part, MA organization offering an MA-PD plan under
part C, or a pharmacist to verify that a practitioner, with
respect to a prescription for a covered part D drug, has a
waiver (or is otherwise exempt) under subparagraph (B) from
the requirement under subparagraph (A).
``(ii) Nothing in this paragraph shall be construed as
affecting the ability of the plan to cover or the
pharmacists' ability to continue to dispense covered part D
drugs from otherwise valid written, oral or fax prescriptions
that are consistent with laws and regulations.
``(iii) Nothing in this paragraph shall be construed as
affecting the ability of an individual who is being
prescribed a covered part D drug to designate a particular
pharmacy to dispense the covered part D drug to the extent
consistent with the requirements under subsection (b)(1) and
under this paragraph.
``(D) Enforcement.--The Secretary shall, through
rulemaking, have authority to enforce and specify appropriate
penalties for non-compliance with the requirement under
subparagraph (A).''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply to coverage of drugs prescribed on or after
January 1, 2021.
SEC. 2105. STANDARDIZING ELECTRONIC PRIOR AUTHORIZATION FOR
SAFE PRESCRIBING.
Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C.
1395w-104(e)(2)) is amended by adding at the end the
following new subparagraph:
``(E) Electronic prior authorization.--
``(i) In general.--Not later than January 1, 2021, the
program shall provide for the secure electronic transmittal
of--
``(I) a prior authorization request from the prescribing
health care professional for coverage of a covered part D
drug for a part D eligible individual enrolled in a part D
plan (as defined in section 1860D-23(a)(5)) to the PDP
sponsor or Medicare Advantage organization offering such
plan; and
``(II) a response, in accordance with this subparagraph,
from such PDP sponsor or Medicare Advantage organization,
respectively, to such professional.
``(ii) Electronic transmission.--
``(I) Exclusions.--For purposes of this subparagraph, a
facsimile, a proprietary payer portal that does not meet
standards specified by the Secretary, or an electronic form
shall not be treated as an electronic transmission described
in clause (i).
``(II) Standards.--In order to be treated, for purposes of
this subparagraph, as an electronic transmission described in
clause (i), such transmission shall comply with technical
standards adopted by the Secretary in consultation with the
National Council for Prescription Drug Programs, other
standard setting organizations determined appropriate by the
Secretary, and stakeholders including PDP sponsors, Medicare
Advantage organizations, health care professionals, and
health information technology software vendors.
``(III) Application.--Notwithstanding any other provision
of law, for purposes of this subparagraph, the Secretary may
require the use of such standards adopted under subclause
(II) in lieu of any other applicable standards for an
electronic transmission described in clause (i) for a covered
part D drug for a part D eligible individual.''.
SEC. 2106. STRENGTHENING PARTNERSHIPS TO PREVENT OPIOID
ABUSE.
(a) In General.--Section 1859 of the Social Security Act
(42 U.S.C. 1395w-28) is amended by adding at the end the
following new subsection:
``(i) Program Integrity Transparency Measures.--
``(1) Program integrity portal.--
``(A) In general.--Not later than 2 years after the date of
the enactment of this subsection, the Secretary shall, after
consultation with stakeholders, establish a secure Internet
website portal that would allow a secure path for
communication between the Secretary, MA plans under this
part, prescription drug plans under part D, and an eligible
entity with a contract under section 1893 (such as a Medicare
drug integrity contractor or any successor entity to a
Medicare drug integrity contractor), in accordance with
subsection (j)(3) of such section, for the purpose of
enabling through such portal--
``(i) the referral by such plans of suspicious activities
of a provider of services (including a prescriber) or
supplier related to fraud, waste, and abuse for initiating or
assisting investigations conducted by the eligible entity;
and
``(ii) data sharing among such MA plans, prescription drug
plans, and the Secretary.
``(B) Required uses of portal.--The Secretary shall
disseminate the following information to MA plans under this
part and prescription drug plans under part D through the
secure Internet website portal established under subparagraph
(A):
``(i) Providers of services and suppliers that have been
referred pursuant to subparagraph (A)(i) during the previous
12-month period.
``(ii) Providers of services and suppliers who are the
subject of an active exclusion under section 1128 or who are
subject to a suspension of payment under this title pursuant
to section 1862(o) or otherwise.
``(iii) Providers of services and suppliers who are the
subject of an active revocation of participation under this
title, including for not satisfying conditions of
participation.
[[Page S6085]]
``(iv) In the case of such a plan that makes a referral
under subparagraph (A)(i) through the portal with respect to
suspicious activities of a provider of services (including a
prescriber) or supplier, if such provider (or prescriber) or
supplier has been the subject of an administrative action
under this title or title XI with respect to similar
activities, a notification to such plan of such action so
taken.
``(C) Rulemaking.--For purposes of this paragraph, the
Secretary shall, through rulemaking, specify what constitutes
suspicious activities related to fraud, waste, and abuse,
using guidance such as what is provided in the Medicare
Program Integrity Manual 4.7.1.
``(2) Quarterly reports.--Beginning not later than 2 years
after the date of the enactment of this subsection, the
Secretary shall make available to MA plans under this part
and prescription drug plans under part D in a timely manner
(but no less frequently than quarterly) and using information
submitted to an entity described in paragraph (1) through the
portal described in such paragraph or pursuant to section
1893, information on fraud, waste, and abuse schemes and
trends in identifying suspicious activity. Information
included in each such report shall--
``(A) include administrative actions, pertinent information
related to opioid overprescribing, and other data determined
appropriate by the Secretary in consultation with
stakeholders; and
``(B) be anonymized information submitted by plans without
identifying the source of such information.
``(3) Clarification.--Nothing in this subsection shall
preclude or otherwise affect referrals to the Inspector
General of the Department of Health and Human Services or
other law enforcement entities.''.
(b) Contract Requirement to Communicate Plan Corrective
Actions Against Opioids Over-prescribers.--Section
1857(e)(4)(C) of the Social Security Act (42 U.S.C. 1395w-
27(e)(4)(C)) is amended by adding at the end the following
new paragraph:
``(5) Communicating plan corrective actions against opioids
over-prescribers.--
``(A) In general.--Beginning with plan years beginning on
or after January 1, 2021, a contract under this section with
an MA organization shall require the organization to submit
to the Secretary, through the process established under
subparagraph (B), information on credible evidence of
suspicious activities of a provider of services (including a
prescriber) or supplier related to fraud and other actions
taken by such plans related to inappropriate prescribing of
opioids.
``(B) Process.--Not later than January 1, 2021, the
Secretary shall, in consultation with stakeholders, establish
a process under which MA plans and prescription drug plans
shall submit to the Secretary information described in
subparagraph (A).
``(C) Regulations.--For purposes of this paragraph,
including as applied under section 1860D-12(b)(3)(D), the
Secretary shall, pursuant to rulemaking--
``(i) specify a definition for the term `inappropriate
prescribing of opioids' and a method for determining if a
provider of services prescribes such a high volume; and
``(ii) establish the process described in subparagraph (B)
and the types of information that may be submitted through
such process.''.
(c) Reference Under Part D to Program Integrity
Transparency Measures.--Section 1860D-4 of the Social
Security Act (42 U.S.C. 1395w-104) is amended by adding at
the end the following new subsection:
``(m) Program Integrity Transparency Measures.--For program
integrity transparency measures applied with respect to
prescription drug plan and MA plans, see section 1859(i).''.
SEC. 2107. COMMIT TO OPIOID MEDICAL PRESCRIBER ACCOUNTABILITY
AND SAFETY FOR SENIORS.
Section 1860D-4(c)(4) of the Social Security Act (42 U.S.C.
1395w-104(c)(4)) is amended by adding at the end the
following new subparagraph:
``(D) Notification and additional requirements with respect
to statistical outlier prescribers of opioids.--
``(i) Notification.--Not later than January 1, 2021, the
Secretary shall, in the case of a prescriber identified by
the Secretary under clause (ii) to be a statistical outlier
prescriber of opioids, provide, subject to clause (iv), an
annual notification to such prescriber that such prescriber
has been so identified that includes resources on proper
prescribing methods and other information as specified in
accordance with clause (iii).
``(ii) Identification of statistical outlier prescribers of
opioids.--
``(I) In general.--The Secretary shall, subject to
subclause (III), using the valid prescriber National Provider
Identifiers included pursuant to subparagraph (A) on claims
for covered part D drugs for part D eligible individuals
enrolled in prescription drug plans under this part or MA-PD
plans under part C and based on the thresholds established
under subclause (II), identify prescribers that are
statistical outlier opioids prescribers for a period of time
specified by the Secretary.
``(II) Establishment of thresholds.--For purposes of
subclause (I) and subject to subclause (III), the Secretary
shall, after consultation with stakeholders, establish
thresholds, based on prescriber specialty and, as determined
appropriate by the Secretary, geographic area, for
identifying whether a prescriber in a specialty and
geographic area is a statistical outlier prescriber of
opioids as compared to other prescribers of opioids within
such specialty and area.
``(III) Exclusions.--The following shall not be included in
the analysis for identifying statistical outlier prescribers
of opioids under this clause:
``(aa) Claims for covered part D drugs for part D eligible
individuals who are receiving hospice care under this title.
``(bb) Claims for covered part D drugs for part D eligible
individuals who are receiving oncology services under this
title.
``(cc) Prescribers who are the subject of an investigation
by the Centers for Medicare & Medicaid Services or the
Inspector General of the Department of Health and Human
Services.
``(iii) Contents of notification.--The Secretary shall
include the following information in the notifications
provided under clause (i):
``(I) Information on how such prescriber compares to other
prescribers within the same specialty and, if determined
appropriate by the Secretary, geographic area.
``(II) Information on opioid prescribing guidelines, based
on input from stakeholders, that may include the Centers for
Disease Control and Prevention guidelines for prescribing
opioids for chronic pain and guidelines developed by
physician organizations.
``(III) Other information determined appropriate by the
Secretary.
``(iv) Modifications and expansions.--
``(I) Frequency.--Beginning 5 years after the date of the
enactment of this subparagraph, the Secretary may change the
frequency of the notifications described in clause (i) based
on stakeholder input and changes in opioid prescribing
utilization and trends.
``(II) Expansion to other prescriptions.--The Secretary may
expand notifications under this subparagraph to include
identifications and notifications with respect to concurrent
prescriptions of covered Part D drugs used in combination
with opioids that are considered to have adverse side effects
when so used in such combination, as determined by the
Secretary.
``(v) Additional requirements for persistent statistical
outlier prescribers.--In the case of a prescriber who the
Secretary determines is persistently identified under clause
(ii) as a statistical outlier prescriber of opioids, the
following shall apply:
``(I) The Secretary shall provide an opportunity for such
prescriber to receive technical assistance or educational
resources on opioid prescribing guidelines (such as the
guidelines described in clause (iii)(II)) from an entity that
furnishes such assistance or resources, which may include a
quality improvement organization under part B of title XI, as
available and appropriate.
``(II) Such prescriber may be required to enroll in the
program under this title under section 1866(j) if such
prescriber is not otherwise required to enroll. The Secretary
shall determine the length of the period for which such
prescriber is required to maintain such enrollment.
``(III) Not less frequently than annually (and in a form
and manner determined appropriate by the Secretary), the
Secretary shall communicate information on such prescribers
to sponsors of a prescription drug plan and Medicare
Advantage organizations offering an MA-PD plan.
``(vi) Public availability of information.--The Secretary
shall make aggregate information under this subparagraph
available on the Internet website of the Centers for Medicare
& Medicaid Services. Such information shall be in a form and
manner determined appropriate by the Secretary and shall not
identify any specific prescriber. In carrying out this
clause, the Secretary shall consult with interested
stakeholders.
``(vii) Opioids defined.--For purposes of this
subparagraph, the term `opioids' has such meaning as
specified by the Secretary.
``(viii) Other activities.--Nothing in this subparagraph
shall preclude the Secretary from conducting activities that
provide prescribers with information as to how they compare
to other prescribers that are in addition to the activities
under this subparagraph, including activities that were being
conducted as of the date of the enactment of this
subparagraph.''.
SEC. 2108. FIGHTING THE OPIOID EPIDEMIC WITH SUNSHINE.
(a) Inclusion of Information Regarding Payments to Advance
Practice Nurses.--
(1) In general.--Section 1128G(e)(6) of the Social Security
Act (42 U.S.C. 1320a-7h(e)(6)) is amended--
(A) in subparagraph (A), by adding at the end the following
new clauses:
``(iii) A physician assistant, nurse practitioner, or
clinical nurse specialist (as such terms are defined in
section 1861(aa)(5)).
``(iv) A certified registered nurse anesthetist (as defined
in section 1861(bb)(2)).
``(v) A certified nurse-midwife (as defined in section
1861(gg)(2)).''; and
(B) in subparagraph (B), by inserting ``, physician
assistant, nurse practitioner, clinical nurse specialist,
certified nurse anesthetist, or certified nurse-midwife''
after ``physician''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to information required to be
submitted under section 1128G of the Social Security Act (42
U.S.C. 1320a-7h) on or after January 1, 2022.
[[Page S6086]]
(b) Sunset of Exclusion of National Provider Identifier of
Covered Recipient in Information Made Publicly Available.--
Section 1128G(c)(1)(C)(viii) of the Social Security Act (42
U.S.C. 1320a-7h(c)(1)(C)(viii))) is amended by striking
``does not contain'' and inserting ``in the case of
information made available under this subparagraph prior to
January 1, 2022, does not contain''.
(c) Administration.--Chapter 35 of title 44, United States
Code, shall not apply to this section or the amendments made
by this section.
SEC. 2109. DEMONSTRATION TESTING COVERAGE OF CERTAIN SERVICES
FURNISHED BY OPIOID TREATMENT PROGRAMS.
Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended by inserting after section 1866E the
following:
``demonstration testing coverage of certain services furnished by
opioid treatment programs
``Sec. 1866F. (a) Establishment.--
``(1) In general.--The Secretary shall conduct a
demonstration (in this section referred to as the
`demonstration') to test coverage of and payment for opioid
use disorder treatment services (as defined in paragraph
(2)(B)) furnished by opioid treatment programs (as defined in
paragraph (2)(A)) to individuals under part B using a bundled
payment as described in paragraph (3).
``(2) Definitions.--In this section:
``(A) Opioid treatment program.--The term `opioid treatment
program' means an entity that is an opioid treatment program
(as defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(i) is selected for participation in the demonstration;
``(ii) has in effect a certification by the Substance Abuse
and Mental Health Services Administration for such a program;
``(iii) is accredited by an accrediting body approved by
the Substance Abuse and Mental Health Services
Administration;
``(iv) submits to the Secretary data and information needed
to monitor the quality of services furnished and conduct the
evaluation described in subsection (c); and
``(v) meets such additional requirements as the Secretary
may find necessary.
``(B) Opioid use disorder treatment services.--The term
`opioid use disorder treatment services' means items and
services that are furnished by an opioid treatment program
for the treatment of opioid use disorder, including--
``(i) opioid agonist and antagonist treatment medications
(including oral, injected, or implanted versions) that are
approved by the Food and Drug Administration under section
505 of the Federal Food, Drug and Cosmetic Act for use in the
treatment of opioid use disorder;
``(ii) dispensing and administration of such medications,
if applicable;
``(iii) substance use counseling by a professional to the
extent authorized under State law to furnish such services;
``(iv) individual and group therapy with a physician or
psychologist (or other mental health professional to the
extent authorized under State law);
``(v) toxicology testing; and
``(vi) other items and services that the Secretary
determines are appropriate (but in no case to include meals
or transportation).
``(3) Bundled payment under part b.--
``(A) In general.--The Secretary shall pay, from the
Federal Supplementary Medical Insurance Trust Fund under
section 1841, to an opioid treatment program participating in
the demonstration a bundled payment as determined by the
Secretary for opioid use disorder treatment services that are
furnished by such treatment program to an individual under
part B during an episode of care (as defined by the
Secretary).
``(B) Considerations.--The Secretary may implement this
paragraph through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services furnished, the scope of services furnished,
characteristics of the individuals furnished such services,
or other factors as the Secretary determines appropriate. In
developing such bundles, the Secretary may consider payment
rates paid to opioid treatment programs for comparable
services under State plans under title XIX or under the
TRICARE program under chapter 55 of title 10 of the United
States Code.
``(b) Implementation.--
``(1) Duration.--The demonstration shall be conducted for a
period of 5 years, beginning not later than January 1, 2021.
``(2) Scope.--In carrying out the demonstration, the
Secretary shall limit the number of beneficiaries that may
participate at any one time in the demonstration to 2,000.
``(3) Waiver.--The Secretary may waive such provisions of
this title and title XI as the Secretary determines necessary
in order to implement the demonstration.
``(4) Administration.--Chapter 35 of title 44, United
States Code, shall not apply to this section.
``(c) Evaluation and Report.--
``(1) Evaluation.--The Secretary shall conduct an
evaluation of the demonstration. Such evaluation shall
include analyses of--
``(A) the impact of the demonstration on--
``(i) utilization of health care items and services related
to opioid use disorder, including hospitalizations and
emergency department visits;
``(ii) beneficiary health outcomes related to opioid use
disorder, including opioid overdose deaths; and
``(iii) overall expenditures under this title; and
``(B) the performance of opioid treatment programs
participating in the demonstration with respect to applicable
quality and cost metrics, including whether any additional
quality measures related to opioid use disorder treatment are
needed with respect to such programs under this title.
``(2) Report.--Not later than 2 years after the completion
of the demonstration, the Secretary shall submit to Congress
a report containing the results of the evaluation conducted
under paragraph (1), together with recommendations for such
legislation and administrative action as the Secretary
determines appropriate.
``(d) Funding.--For purposes of administering and carrying
out the demonstration, in addition to funds otherwise
appropriated, there shall be transferred to the Secretary for
the Center for Medicare & Medicaid Services Program
Management Account from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 $5,000,000, to remain
available until expended.''.
SEC. 2110. ENCOURAGING APPROPRIATE PRESCRIBING UNDER MEDICARE
FOR VICTIMS OF OPIOID OVERDOSE.
Section 1860D-4(c)(5)(C) of the Social Security Act (42
U.S.C. 1395w-104(c)(5)(C)) is amended--
(1) in clause (i), in the matter preceding subclause (I),
by striking ``For purposes'' and inserting ``Except as
provided in clause (v), for purposes''; and
(2) by adding at the end the following new clause:
``(v) Treatment of enrollees with a history of opioid-
related overdose.--
``(I) In general.--For plan years beginning not later than
January 1, 2021, a part D eligible individual who is not an
exempted individual described in clause (ii) and who is
identified under this clause as a part D eligible individual
with a history of opioid-related overdose (as defined by the
Secretary) shall be included as a potentially at-risk
beneficiary for prescription drug abuse under the drug
management program under this paragraph.
``(II) Identification and notice.--For purposes of this
clause, the Secretary shall--
``(aa) identify part D eligible individuals with a history
of opioid-related overdose (as so defined); and
``(bb) notify the PDP sponsor of the prescription drug plan
in which such an individual is enrolled of such
identification.''.
SEC. 2111. AUTOMATIC ESCALATION TO EXTERNAL REVIEW UNDER A
MEDICARE PART D DRUG MANAGEMENT PROGRAM FOR AT-
RISK BENEFICIARIES.
(a) In General.--Section 1860D-4(c)(5) of the Social
Security Act (42 U.S.C. 1395ww-10(c)(5)) is amended--
(1) in subparagraph (B), in each of clauses (ii)(III) and
(iii)(IV), by striking ``and the option of an automatic
escalation to external review'' and inserting ``, including
notice that if on reconsideration a PDP sponsor affirms its
denial, in whole or in part, the case shall be automatically
forwarded to the independent, outside entity contracted with
the Secretary for review and resolution''; and
(2) in subparagraph (E), by striking ``and the option'' and
all that follows and inserting the following: ``and if on
reconsideration a PDP sponsor affirms its denial, in whole or
in part, the case shall be automatically forwarded to the
independent, outside entity contracted with the Secretary for
review and resolution.''.
(b) Effective Date.--The amendments made by subsection (a)
shall apply beginning not later January 1, 2021.
SEC. 2112. TESTING OF INCENTIVE PAYMENTS FOR BEHAVIORAL
HEALTH PROVIDERS FOR ADOPTION AND USE OF
CERTIFIED ELECTRONIC HEALTH RECORD TECHNOLOGY.
Section 1115A(b)(2)(B) of the Social Security Act (42
U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the
following new clause:
``(xxv) Providing incentive payments to behavioral health
providers for the adoption and use of certified electronic
health record technology (as defined in section 1848(o)(4))
to improve the quality and coordination of care through the
electronic documentation and exchange of health information.
Behavioral health providers may include--
``(I) psychiatric hospitals (as defined in section
1861(f));
``(II) community mental health centers (as defined in
section 1861(ff)(3)(B));
``(III) clinical psychologists (as defined in section
1861(ii));
``(IV) clinical social workers (as defined in section
1861(hh)(1)); and
``(V) hospitals, treatment facilities, and mental health or
substance use disorder providers that participate in a State
plan under title XIX or a waiver of such plan.''.
SEC. 2113. MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``fiscal year 2021,
$0'' and inserting ``fiscal year 2024, $65,000,000''.
Subtitle B--Medicaid
SEC. 2201. CARING RECOVERY FOR INFANTS AND BABIES.
(a) State Plan Amendment.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)) is amended--
(1) in paragraph (82), by striking ``and'' after the
semicolon;
[[Page S6087]]
(2) in paragraph (83), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (83), the following new
paragraph:
``(84) provide, at the option of the State, for making
medical assistance available on an inpatient or outpatient
basis at a residential pediatric recovery center (as defined
in subsection (nn)) to infants with neonatal abstinence
syndrome.''.
(b) Residential Pediatric Recovery Center Defined.--Section
1902 of such Act (42 U.S.C. 1396a) is amended by adding at
the end the following new subsection:
``(nn) Residential Pediatric Recovery Center Defined.--
``(1) In general.--For purposes of section 1902(a)(84), the
term `residential pediatric recovery center' means 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.
``(2) Counseling and services.--A residential pediatric
recovery center may offer counseling and other services to
mothers (and other appropriate family members and caretakers)
of infants receiving treatment at such centers if such
services are otherwise covered under the State plan under
this title or under a waiver of such plan. Such other
services may include the following:
``(A) Counseling or referrals for services.
``(B) Activities to encourage caregiver-infant bonding.
``(C) Training on caring for such infants.''.
(c) Effective Date.--The amendments made by this section
take effect on the date of enactment of this Act and shall
apply to medical assistance furnished on or after that date,
without regard to final regulations to carry out such
amendments being promulgated as of such date.
SEC. 2202. PEER SUPPORT ENHANCEMENT AND EVALUATION REVIEW.
(a) In General.--Not later than 2 years after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Energy and
Commerce of the House of Representatives, the Committee on
Finance of the Senate, and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
provision of peer support services under the Medicaid
program.
(b) Content of Report.--
(1) In general.--The report required under subsection (a)
shall include the following information:
(A) Information on State coverage of peer support services
under Medicaid, including--
(i) the mechanisms through which States may provide such
coverage, including through existing statutory authority or
through waivers;
(ii) the populations to which States have provided such
coverage;
(iii) the payment models, including any alternative payment
models, used by States to pay providers of such services; and
(iv) where available, information on Federal and State
spending under Medicaid for peer support services.
(B) Information on selected State experiences in providing
medical assistance for peer support services under State
Medicaid plans and whether States measure the effects of
providing such assistance with respect to--
(i) improving access to behavioral health services;
(ii) improving early detection, and preventing worsening,
of behavioral health disorders;
(iii) reducing chronic and comorbid conditions; and
(iv) reducing overall health costs.
(2) Recommendations.--The report required under subsection
(a) shall include recommendations, including recommendations
for such legislative and administrative actions related to
improving services, including peer support services, and
access to peer support services under Medicaid as the
Comptroller General of the United States determines
appropriate.
SEC. 2203. MEDICAID SUBSTANCE USE DISORDER TREATMENT VIA
TELEHEALTH.
(a) Definitions.--In this section:
(1) Comptroller general.--The term ``Comptroller General''
means the Comptroller General of the United States.
(2) School-based health center.--The term ``school-based
health center'' has the meaning given that term in section
2110(c)(9) of the Social Security Act (42 U.S.C.
1397jj(c)(9)).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(4) Teleheath services.--The term ``telehealth services''
includes remote patient monitoring and other key modalities
such as live video or synchronous telehealth, store-and-
forward or asynchronous telehealth, mobile health, telephonic
consultation, and electronic consult including provider-to-
provider e-consults.
(5) Underserved area.--The term ``underserved area'' means
a health professional shortage area (as defined in section
332(a)(1)(A) of the Public Health Service Act (42 U.S.C.
254e(a)(1)(A))) and a medically underserved area (according
to a designation under section 330(b)(3)(A) of the Public
Health Service Act (42 U.S.C. 254b(b)(3)(A))).
(b) Guidance to States Regarding Federal Reimbursement for
Furnishing Services and Treatment for Substance Use Disorders
Under Medicaid Using Telehealth Services, Including in
School-based Health Centers.--Not later than 1 year after the
date of enactment of this Act, the Secretary, acting through
the Administrator of the Centers for Medicare & Medicaid
Services, shall issue guidance to States on the following:
(1) State options for Federal reimbursement of expenditures
under Medicaid for furnishing services and treatment for
substance use disorders, including assessment, medication-
assisted treatment, counseling, and medication management,
using telehealth services. Such guidance shall also include
guidance on furnishing services and treatments that address
the needs of high risk individuals, including at least the
following groups:
(A) American Indians and Alaska Natives.
(B) Adults under the age of 40.
(C) Individuals with a history of nonfatal overdose.
(2) State options for Federal reimbursement of expenditures
under Medicaid for education directed to providers serving
Medicaid beneficiaries with substance use disorders using the
hub and spoke model, through contracts with managed care
entities, through administrative claiming for disease
management activities, and under Delivery System Reform
Incentive Payment (``DSRIP'') programs.
(3) State options for Federal reimbursement of expenditures
under Medicaid for furnishing services and treatment for
substance use disorders for individuals enrolled in Medicaid
in a school-based health center using telehealth services.
(c) GAO Evaluation of Children's Access to Services and
Treatment for Substance Use Disorders Under Medicaid.--
(1) Study.--The Comptroller General shall evaluate
children's access to services and treatment for substance use
disorders under Medicaid. The evaluation shall include an
analysis of State options for improving children's access to
such services and treatment and for improving outcomes,
including by increasing the number of Medicaid providers who
offer services or treatment for substance use disorders in a
school-based health center using telehealth services,
particularly in rural and underserved areas. The evaluation
shall include an analysis of Medicaid provider reimbursement
rates for services and treatment for substance use disorders.
(2) Report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General shall submit
to Congress a report containing the results of the evaluation
conducted under paragraph (1), together with recommendations
for such legislation and administrative action as the
Comptroller General determines appropriate.
(d) Report on Reducing Barriers to Using Telehealth
Services and Remote Patient Monitoring for Pediatric
Populations Under Medicaid.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Administrator of the Centers for Medicare & Medicaid
Services, shall issue a report to the Committee on Finance of
the Senate and the Committee on Energy and Commerce of the
House of Representative identifying best practices and
potential solutions for reducing barriers to using telehealth
services to furnish services and treatment for substance use
disorders among pediatric populations under Medicaid. The
report shall include--
(A) analyses of the best practices, barriers, and potential
solutions for using telehealth services to diagnose and
provide services and treatment for children with substance
use disorders, including opioid use disorder; and
(B) identification and analysis of the differences, if any,
in furnishing services and treatment for children with
substance use disorders using telehealth services and using
services delivered in person, such as, and to the extent
feasible, with respect to--
(i) utilization rates;
(ii) costs;
(iii) avoidable inpatient admissions and readmissions;
(iv) quality of care; and
(v) patient, family, and provider satisfaction.
(2) Publication.--The Secretary shall publish the report
required under paragraph (1) on a public Internet website of
the Department of Health and Human Services.
SEC. 2204. ENHANCING PATIENT ACCESS TO NON-OPIOID TREATMENT
OPTIONS.
Not later than January 1, 2019, the Secretary of Health and
Human Services, acting through the Administrator of the
Centers for Medicare & Medicaid Services, shall issue 1 or
more final guidance documents, or update existing guidance
documents, to States regarding mandatory and optional items
and services that may be provided under a State plan under
title XIX of the Social Security Act (42 U.S.C. 1396 et
seq.), or under a waiver of such a plan, for non-opioid
treatment and management of pain, including, but not limited
to, evidence-based non-opioid pharmacological therapies and
non-pharmacological therapies.
SEC. 2205. ASSESSING BARRIERS TO OPIOID USE DISORDER
TREATMENT.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study regarding the barriers to
providing medication used in the treatment of substance use
disorders under Medicaid distribution models such as the
``buy-and-bill'' model, and options for State Medicaid
programs to remove or reduce such barriers.
[[Page S6088]]
The study shall include analyses of each of the following
models of distribution of substance use disorder treatment
medications, particularly buprenorphine, naltrexone, and
buprenorphine-naloxone combinations:
(A) The purchasing, storage, and administration of
substance use disorder treatment medications by providers.
(B) The dispensing of substance use disorder treatment
medications by pharmacists.
(C) The ordering, prescribing, and obtaining substance use
disorder treatment medications on demand from specialty
pharmacies by providers.
(2) Requirements.--For each model of distribution specified
in paragraph (1), the Comptroller General shall evaluate how
each model presents barriers or could be used by selected
State Medicaid programs to reduce the barriers related to the
provision of substance use disorder treatment by examining
what is known about the effects of the model of distribution
on--
(A) Medicaid beneficiaries' access to substance use
disorder treatment medications;
(B) the differential cost to the program between each
distribution model for medication assisted treatment; and
(C) provider willingness to provide or prescribe substance
use disorder treatment medications.
(b) Report.--Not later than 15 months after the date of the
enactment of this Act, the Comptroller General shall submit
to Congress a report containing the results of the study
conducted under subsection (a), together with recommendations
for such legislation and administrative action as the
Comptroller General determines appropriate.
SEC. 2206. HELP FOR MOMS AND BABIES.
(a) Medicaid State Plan.--Section 1905(a) of the Social
Security Act (42 U.S.C. 1396d(a)) is amended by adding at the
end the following new sentence: ``In the case of a woman who
is eligible for medical assistance on the basis of being
pregnant (including through the end of the month in which the
60-day period beginning on the last day of her pregnancy
ends), who is a patient in an institution for mental diseases
for purposes of receiving treatment for a substance use
disorder, and who was enrolled for medical assistance under
the State plan immediately before becoming a patient in an
institution for mental diseases or who becomes eligible to
enroll for such medical assistance while such a patient, the
exclusion from the definition of `medical assistance' set
forth in the subdivision (B) following paragraph (29) of the
first sentence of this subsection shall not be construed as
prohibiting Federal financial participation for medical
assistance for items or services that are provided to the
woman outside of the institution.''.
(b) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendment made by subsection (a) shall take effect on the
date of enactment of this Act.
(2) Rule for changes requiring state legislation.--In the
case of a State plan under title XIX of the Social Security
Act which the Secretary of Health and Human Services
determines requires State legislation (other than legislation
appropriating funds) in order for the plan to meet the
additional requirements imposed by the amendment made by
subsection (a), the State plan shall not be regarded as
failing to comply with the requirements of such title solely
on the basis of its failure to meet these additional
requirements before the first day of the first calendar
quarter beginning after the close of the first regular
session of the State legislature that begins after the date
of the enactment of this Act. For purposes of the previous
sentence, in the case of a State that has a 2-year
legislative session, each year of such session shall be
deemed to be a separate regular session of the State
legislature.
SEC. 2207. SECURING FLEXIBILITY TO TREAT SUBSTANCE USE
DISORDERS.
Section 1903(m) of the Social Security Act (42 U.S.C.
1396b(m)) is amended by adding at the end the following new
paragraph:
``(7) Payment shall be made under this title to a State for
expenditures for capitation payments described in section
438.6(e) of title 42, Code of Federal Regulations (or any
successor regulation).''.
SEC. 2208. MACPAC STUDY AND REPORT ON MAT UTILIZATION
CONTROLS UNDER STATE MEDICAID PROGRAMS.
(a) Study.--The Medicaid and CHIP Payment and Access
Commission shall conduct a study and analysis of utilization
control policies applied to medication-assisted treatment for
substance use disorders under State Medicaid programs,
including policies and procedures applied both in fee-for-
service Medicaid and in risk-based managed care Medicaid,
which shall--
(1) include an inventory of such utilization control
policies and related protocols for ensuring access to
medically necessary treatment;
(2) determine whether managed care utilization control
policies and procedures for medication assisted treatment for
substance use disorders are consistent with section
438.210(a)(4)(ii) of title 42, Code of Federal Regulations;
and
(3) identify policies that--
(A) limit an individual's access to medication-assisted
treatment for a substance use disorder by limiting the
quantity of medication-assisted treatment prescriptions, or
the number of refills for such prescriptions, available to
the individual as part of a prior authorization process or
similar utilization protocols; and
(B) apply without evaluating individual instances of fraud,
waste, or abuse.
(b) Report.--Not later than 1 year after the date of the
enactment of this Act, the Medicaid and CHIP Payment and
Access Commission shall make publicly available a report
containing the results of the study conducted under
subsection (a).
SEC. 2209. OPIOID ADDICTION TREATMENT PROGRAMS ENHANCEMENT.
(a) T-MSIS Substance Use Disorder Data Book.--
(1) In general.--Not later than the date that is 12 months
after the date of enactment of this Act, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall publish on the public website of the
Centers for Medicare & Medicaid Services a report with
comprehensive data on the prevalence of substance use
disorders in the Medicaid beneficiary population and services
provided for the treatment of substance use disorders under
Medicaid.
(2) Content of report.--The report required under paragraph
(1) shall include, at a minimum, the following data for each
State (including, to the extent available, for the District
of Columbia, Puerto Rico, the Virgin Islands, Guam, the
Northern Mariana Islands, and American Samoa):
(A) The number and percentage of individuals enrolled in
the State Medicaid plan or waiver of such plan in each of the
major enrollment categories (as defined in a public letter
from the Medicaid and CHIP Payment and Access Commission to
the Secretary) who have been diagnosed with a substance use
disorder and whether such individuals are enrolled under the
State Medicaid plan or a waiver of such plan, including the
specific waiver authority under which they are enrolled, to
the extent available.
(B) A list of the substance use disorder treatment services
by each major type of service, such as counseling, medication
assisted treatment, peer support, residential treatment, and
inpatient care, for which beneficiaries in each State
received at least 1 service under the State Medicaid plan or
a waiver of such plan.
(C) The number and percentage of individuals with a
substance use disorder diagnosis enrolled in the State
Medicaid plan or waiver of such plan who received substance
use disorder treatment services under such plan or waiver by
each major type of service under subparagraph (B) within each
major setting type, such as outpatient, inpatient,
residential, and other home and community-based settings.
(D) The number of services provided under the State
Medicaid plan or waiver of such plan per individual with a
substance use disorder diagnosis enrolled in such plan or
waiver for each major type of service under subparagraph (B).
(E) The number and percentage of individuals enrolled in
the State Medicaid plan or waiver, by major enrollment
category, who received substance use disorder treatment
through--
(i) a medicaid managed care entity (as defined in section
1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u-
2(a)(1)(B))), including the number of such individuals who
received such assistance through a prepaid inpatient health
plan or a prepaid ambulatory health plan;
(ii) a fee-for-service payment model; or
(iii) an alternative payment model, to the extent
available.
(F) The number and percentage of individuals with a
substance use disorder who receive substance use disorder
treatment services in an outpatient or home and community-
based setting after receiving treatment in an inpatient or
residential setting, and the number of services received by
such individuals in the outpatient or home and community-
based setting.
(3) Annual updates.--The Secretary shall issue an updated
version of the report required under paragraph (1) not later
than January 1 of each calendar year through 2024.
(4) Use of t-msis data.--The report required under
paragraph (1) and updates required under paragraph (3)
shall--
(A) use data and definitions from the Transformed Medicaid
Statistical Information System (``T-MSIS'') data set that is
no more than 12 months old on the date that the report or
update is published; and
(B) as appropriate, include a description with respect to
each State of the quality and completeness of the data and
caveats describing the limitations of the data reported to
the Secretary by the State that is sufficient to communicate
the appropriate uses for the information.
(b) Making T-MSIS Data on Substance Use Disorders Available
to Researchers.--
(1) In general.--The Secretary shall publish in the Federal
Register a system of records notice for the data specified in
paragraph (2) for the Transformed Medicaid Statistical
Information System, in accordance with section 552a(e)(4) of
title 5, United States Code. The notice shall outline
policies that protect the security and privacy of the data
that, at a minimum, meet the security and privacy policies of
SORN 09-70-0541 for the Medicaid Statistical Information
System.
(2) Required data.--The data covered by the systems of
records notice required under paragraph (1) shall be
sufficient for researchers and States to analyze the
prevalence of
[[Page S6089]]
substance use disorders in the Medicaid beneficiary
population and the treatment of substance use disorders under
Medicaid across all States (including the District of
Columbia, Puerto Rico, the Virgin Islands, Guam, the Northern
Mariana Islands, and American Samoa), forms of treatment, and
treatment settings.
(3) Initiation of data-sharing activities.--Not later than
January 1, 2019, the Secretary shall initiate the data-
sharing activities outlined in the notice required under
paragraph (1).
SEC. 2210. BETTER DATA SHARING TO COMBAT THE OPIOID CRISIS.
(a) In General.--Section 1903(m) of the Social Security Act
(42 U.S.C. 1396b(m)), as amended by section 2207, is amended
by adding at the end the following new paragraph:
``(8)(A) The State agency administering the State plan
under this title may have reasonable access, as determined by
the State, to 1 or more prescription drug monitoring program
databases administered or accessed by the State to the extent
the State agency is permitted to access such databases under
State law.
``(B) Such State agency may facilitate reasonable access,
as determined by the State, to 1 or more prescription drug
monitoring program databases administered or accessed by the
State, to same extent that the State agency is permitted
under State law to access such databases, for--
``(i) any provider enrolled under the State plan to provide
services to Medicaid beneficiaries; and
``(ii) any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under this
subsection or under section 1905(t)(3).
``(C) Such State agency may share information in such
databases, to the same extent that the State agency is
permitted under State law to share information in such
databases, with--
``(i) any provider enrolled under the State plan to provide
services to Medicaid beneficiaries; and
``(ii) any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under this
subsection or under section 1905(t)(3).''.
(b) Security and Privacy.--All applicable State and Federal
security and privacy protections and laws shall apply to any
State agency, individual, or entity accessing 1 or more
prescription drug monitoring program databases or obtaining
information in such databases in accordance with section
1903(m)(8) of the Social Security Act (42 U.S.C. 1396b(m)(8))
(as added by subsection (a)).
(c) Effective Date.--The amendment made by subsection (a)
shall take effect on the date of enactment of this Act.
SEC. 2211. MANDATORY REPORTING WITH RESPECT TO ADULT
BEHAVIORAL HEALTH MEASURES.
Section 1139B of the Social Security Act (42 U.S.C. 1320b-
9b) is amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Not later than January 1, 2013'' and
inserting the following:
``(A) Voluntary reporting.--Not later than January 1,
2013''; and
(ii) by adding at the end the following:
``(B) Mandatory reporting with respect to behavioral health
measures.--Beginning with the State report required under
subsection (d)(1) for 2024, the Secretary shall require
States to use all behavioral health measures included in the
core set of adult health quality measures and any updates or
changes to such measures to report information, using the
standardized format for reporting information and procedures
developed under subparagraph (A), regarding the quality of
behavioral health care for Medicaid eligible adults.'';
(B) in paragraph (5), by adding at the end the following
new subparagraph:
``(C) Behavioral health measures.--Beginning with respect
to State reports required under subsection (d)(1) for 2024,
the core set of adult health quality measures maintained
under this paragraph (and any updates or changes to such
measures) shall include behavioral health measures.''; and
(2) in subsection (d)(1)(A)--
(A) by striking ``the such plan'' and inserting ``such
plan''; and
(B) by striking ``subsection (a)(5)'' and inserting
``subsection (b)(5) and, beginning with the report for 2024,
all behavioral health measures included in the core set of
adult health quality measures maintained under such
subsection (b)(5) and any updates or changes to such measures
(as required under subsection (b)(3))''.
SEC. 2212. REPORT ON INNOVATIVE STATE INITIATIVES AND
STRATEGIES TO PROVIDE HOUSING-RELATED SERVICES
AND SUPPORTS TO INDIVIDUALS STRUGGLING WITH
SUBSTANCE USE DISORDERS UNDER MEDICAID.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue a report to Congress describing
innovative State initiatives and strategies for providing
housing-related services and supports under a State Medicaid
program to individuals with substance use disorders who are
experiencing or at risk of experiencing homelessness.
(b) Content of Report.--The report required under
subsection (a) shall describe the following:
(1) Existing methods and innovative strategies developed
and adopted by State Medicaid programs that have achieved
positive outcomes in increasing housing stability among
Medicaid beneficiaries with substance use disorders who are
experiencing or at risk of experiencing homelessness,
including Medicaid beneficiaries with substance use disorders
who are--
(A) receiving treatment for substance use disorders in
inpatient, residential, outpatient, or home and community-
based settings;
(B) transitioning between substance use disorder treatment
settings; or
(C) living in supportive housing or another model of
affordable housing.
(2) Strategies employed by Medicaid managed care
organizations, primary care case managers, hospitals,
accountable care organizations, and other care coordination
providers to deliver housing-related services and supports
and to coordinate services provided under State Medicaid
programs across different treatment settings.
(3) Innovative strategies and lessons learned by States
with Medicaid waivers approved under section 1115 or 1915 of
the Social Security Act (42 U.S.C. 1315, 1396n), including--
(A) challenges experienced by States in designing,
securing, and implementing such waivers or plan amendments;
(B) how States developed partnerships with other
organizations such as behavioral health agencies, State
housing agencies, housing providers, health care services
agencies and providers, community-based organizations, and
health insurance plans to implement waivers or State plan
amendments; and
(C) how and whether States plan to provide Medicaid
coverage for housing-related services and supports in the
future, including by covering such services and supports
under State Medicaid plans or waivers.
(4) Existing opportunities for States to provide housing-
related services and supports through a Medicaid waiver under
sections 1115 or 1915 of the Social Security Act (42 U.S.C.
1315, 1396n) or through a State Medicaid plan amendment, such
as the Assistance in Community Integration Service pilot
program, which promotes supportive housing and other housing-
related supports under Medicaid for individuals with
substance use disorders and for which Maryland has a waiver
approved under such section 1115 to conduct the program.
(5) Innovative strategies and partnerships developed and
implemented by State Medicaid programs or other entities to
identify and enroll eligible individuals with substance use
disorders who are experiencing or at risk of experiencing
homelessness in State Medicaid programs.
SEC. 2213. TECHNICAL ASSISTANCE AND SUPPORT FOR INNOVATIVE
STATE STRATEGIES TO PROVIDE HOUSING-RELATED
SUPPORTS UNDER MEDICAID.
(a) In General.--The Secretary of Health and Human Services
shall provide technical assistance and support to States
regarding the development and expansion of innovative State
strategies (including through State Medicaid demonstration
projects) to provide housing-related supports and services
and care coordination services under Medicaid to individuals
with substance use disorders.
(b) Report.--Not later than 180 days after the date of
enactment of this Act, the Secretary shall issue a report to
Congress detailing a plan of action to carry out the
requirements of subsection (a).
Subtitle C--Human Services
SEC. 2301. SUPPORTING FAMILY-FOCUSED RESIDENTIAL TREATMENT.
(a) Definitions.--In this section:
(1) Family-focused residential treatment program.--The term
``family-focused residential treatment program'' means a
trauma-informed residential program primarily for substance
use disorder treatment for pregnant and postpartum women and
parents and guardians that allows children to reside with
such women or their parents or guardians during treatment to
the extent appropriate and applicable.
(2) Medicaid program.--The term ``Medicaid program'' means
the program established under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(4) Title iv-e program.--The term ``title IV-E program''
means the program for foster care, prevention, and permanency
established under part E of title IV of the Social Security
Act (42 U.S.C. 670 et seq.).
(b) Guidance on Family-focused Residential Treatment
Programs.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in consultation with
divisions of the Department of Health and Human Services
administering substance use disorder or child welfare
programs, shall develop and issue guidance to States
identifying opportunities to support family-focused
residential treatment programs for the provision of substance
use disorder treatment. Before issuing such guidance, the
Secretary shall solicit input from representatives of States,
health care providers with expertise in addiction medicine,
obstetrics and gynecology, neonatology, child trauma, and
child development, health plans, recipients of family-focused
treatment services, and other relevant stakeholders.
(2) Additional requirements.--The guidance required under
paragraph (1) shall include descriptions of the following:
(A) Existing opportunities and flexibilities under the
Medicaid program, including under
[[Page S6090]]
waivers authorized under section 1115 or 1915 of the Social
Security Act (42 U.S.C. 1315, 1396n), for States to receive
Federal Medicaid funding for the provision of substance use
disorder treatment for pregnant and postpartum women and
parents and guardians and, to the extent applicable, their
children, in family-focused residential treatment programs.
(B) How States can employ and coordinate funding provided
under the Medicaid program, the title IV-E program, and other
programs administered by the Secretary to support the
provision of treatment and services provided by a family-
focused residential treatment facility such as substance use
disorder treatment and services, including medication-
assisted treatment, family, group, and individual counseling,
case management, parenting education and skills development,
the provision, assessment, or coordination of care and
services for children, including necessary assessments and
appropriate interventions, non-emergency transportation for
necessary care provided at or away from a program site,
transitional services and supports for families leaving
treatment, and other services.
(C) How States can employ and coordinate funding provided
under the Medicaid program and the title IV-E program
(including as amended by the Family First Prevention Services
Act enacted under title VII of division E of Public Law 115-
123, and particularly with respect to the authority under
subsections (a)(2)(C) and (j) of section 472 and section
474(a)(1) of the Social Security Act (42 U.S.C. 672,
674(a)(1)) (as amended by section 50712 of Public Law 115-
123) to provide foster care maintenance payments for a child
placed with a parent who is receiving treatment in a licensed
residential family-based treatment facility for a substance
use disorder) to support placing children with their parents
in family-focused residential treatment programs.
SEC. 2302. IMPROVING RECOVERY AND REUNIFYING FAMILIES.
(a) Family Recovery and Reunification Program Replication
Project.--Section 435 of the Social Security Act (42 U.S.C.
629e) is amended by adding at the end the following:
``(e) Family Recovery and Reunification Program Replication
Project.--
``(1) Purpose.--The purpose of this subsection is to
provide resources to the Secretary to support the conduct and
evaluation of a family recovery and reunification program
replication project (referred to in this subsection as the
`project') and to determine the extent to which such programs
may be appropriate for use at different intervention points
(such as when a child is at risk of entering foster care or
when a child is living with a guardian while a parent is in
treatment). The family recovery and reunification program
conducted under the project shall use a recovery coach model
that is designed to help reunify families and protect
children by working with parents or guardians with a
substance use disorder who have temporarily lost custody of
their children.
``(2) Program components.--The family recovery and
reunification program conducted under the project shall
adhere closely to the elements and protocol determined to be
most effective in other recovery coaching programs that have
been rigorously evaluated and shown to increase family
reunification and protect children and, consistent with such
elements and protocol, shall provide such items and services
as--
``(A) assessments to evaluate the needs of the parent or
guardian;
``(B) assistance in receiving the appropriate benefits to
aid the parent or guardian in recovery;
``(C) services to assist the parent or guardian in
prioritizing issues identified in assessments, establishing
goals for resolving such issues that are consistent with the
goals of the treatment provider, child welfare agency,
courts, and other agencies involved with the parent or
guardian or their children, and making a coordinated plan for
achieving such goals;
``(D) home visiting services coordinated with the child
welfare agency and treatment provider involved with the
parent or guardian or their children;
``(E) case management services to remove barriers for the
parent or guardian to participate and continue in treatment,
as well as to re-engage a parent or guardian who is not
participating or progressing in treatment;
``(F) access to services needed to monitor the parent's or
guardian's compliance with program requirements;
``(G) frequent reporting between the treatment provider,
child welfare agency, courts, and other agencies involved
with the parent or guardian or their children to ensure
appropriate information on the parent's or guardian's status
is available to inform decision-making; and
``(H) assessments and recommendations provided by a
recovery coach to the child welfare caseworker responsible
for documenting the parent's or guardian's progress in
treatment and recovery as well as the status of other areas
identified in the treatment plan for the parent or guardian,
including a recommendation regarding the expected safety of
the child if the child is returned to the custody of the
parent or guardian that can be used by the caseworker and a
court to make permanency decisions regarding the child.
``(3) Responsibilities of the secretary.--
``(A) In general.--The Secretary shall, through a grant or
contract with 1 or more entities, conduct and evaluate the
family recovery and reunification program under the project.
``(B) Requirements.--In identifying 1 or more entities to
conduct the evaluation of the family recovery and
reunification program, the Secretary shall--
``(i) determine that the area or areas in which the program
will be conducted have sufficient substance use disorder
treatment providers and other resources (other than those
provided with funds made available to carry out the project)
to successfully conduct the program;
``(ii) determine that the area or areas in which the
program will be conducted have enough potential program
participants, and will serve a sufficient number of parents
or guardians and their children, so as to allow for the
formation of a control group, evaluation results to be
adequately powered, and preliminary results of the evaluation
to be available within 4 years of the program's
implementation;
``(iii) provide the entity or entities with technical
assistance for the program design, including by working with
1 or more entities that are or have been involved in recovery
coaching programs that have been rigorously evaluated and
shown to increase family reunification and protect children
so as to make sure the program conducted under the project
adheres closely to the elements and protocol determined to be
most effective in such other recovery coaching programs;
``(iv) assist the entity or entities in securing adequate
coaching, treatment, child welfare, court, and other
resources needed to successfully conduct the family recovery
and reunification program under the project; and
``(v) ensure the entity or entities will be able to monitor
the impacts of the program in the area or areas in which it
is conducted for at least 5 years after parents or guardians
and their children are randomly assigned to participate in
the program or to be part of the program's control group.
``(4) Evaluation requirements.--
``(A) In general.--The Secretary, in consultation with the
entity or entities conducting the family recovery and
reunification program under the project, shall conduct an
evaluation to determine whether the program has been
implemented effectively and resulted in improvements for
children and families. The evaluation shall have 3
components: a pilot phase, an impact study, and an
implementation study.
``(B) Pilot phase.--The pilot phase component of the
evaluation shall consist of the Secretary providing technical
assistance to the entity or entities conducting the family
recovery and reunification program under the project to
ensure--
``(i) the program's implementation adheres closely to the
elements and protocol determined to be most effective in
other recovery coaching programs that have been rigorously
evaluated and shown to increase family reunification and
protect children; and
``(ii) random assignment of parents or guardians and their
children to be participants in the program or to be part of
the program's control group is being carried out.
``(C) Impact study.--The impact study component of the
evaluation shall determine the impacts of the family recovery
and reunification program conducted under the project on the
parents and guardians and their children participating in the
program. The impact study component shall--
``(i) be conducted using an experimental design that uses a
random assignment research methodology;
``(ii) consistent with previous studies of other recovery
coaching programs that have been rigorously evaluated and
shown to increase family reunification and protect children,
measure outcomes for parents and guardians and their children
over multiple time periods, including for a period of 5
years; and
``(iii) include measurements of family stability and
parent, guardian, and child safety for program participants
and the program control group that are consistent with
measurements of such factors for participants and control
groups from previous studies of other recovery coaching
programs so as to allow results of the impact study to be
compared with the results of such prior studies, including
with respect to comparisons between program participants and
the program control group regarding--
``(I) safe family reunification;
``(II) time to reunification;
``(III) permanency (such as through measures of
reunification, adoption, or placement with guardians);
``(IV) safety (such as through measures of subsequent
maltreatment);
``(V) parental or guardian treatment persistence and
engagement;
``(VI) parental or guardian substance use;
``(VII) juvenile delinquency;
``(VIII) cost; and
``(IX) other measurements agreed upon by the Secretary and
the entity or entities operating the family recovery and
reunification program under the project.
``(D) Implementation study.--The implementation study
component of the evaluation shall be conducted concurrently
with the conduct of the impact study component and shall
include, in addition to such other information as the
Secretary may determine, descriptions and analyses of--
``(i) the adherence of the family recovery and
reunification program conducted under the project to other
recovery coaching programs that have been rigorously
evaluated
[[Page S6091]]
and shown to increase family reunification and protect
children; and
``(ii) the difference in services received or proposed to
be received by the program participants and the program
control group.
``(E) Report.--The Secretary shall publish on an internet
website maintained by the Secretary the following
information:
``(i) A report on the pilot phase component of the
evaluation.
``(ii) A report on the impact study component of the
evaluation.
``(iii) A report on the implementation study component of
the evaluation.
``(iv) A report that includes--
``(I) analyses of the extent to which the program has
resulted in increased reunifications, increased permanency,
case closures, net savings to the State or States involved
(taking into account both costs borne by States and the
Federal government), or other outcomes, or if the program did
not produce such outcomes, an analysis of why the replication
of the program did not yield such results;
``(II) if, based on such analyses, the Secretary determines
the program should be replicated, a replication plan; and
``(III) such recommendations for legislation and
administrative action as the Secretary determines
appropriate.
``(5) Appropriation.--In addition to any amounts otherwise
made available to carry out this subpart, out of any money in
the Treasury of the United States not otherwise appropriated,
there are appropriated $15,000,000 for fiscal year 2019 to
carry out the project, which shall remain available through
fiscal year 2026.''.
(b) Clarification of Payer of Last Resort Application to
Child Welfare Prevention and Family Services.--Section
471(e)(10) of the Social Security Act (42 U.S.C. 671(e)(10)),
as added by section 50711(a)(2) of division E of Public Law
115-123, is amended--
(1) in subparagraph (A), by inserting ``, nor shall the
provision of such services or programs be construed to permit
the State to reduce medical or other assistance available to
a recipient of such services or programs'' after ``under this
Act''; and
(2) by adding at the end the following:
``(C) Payer of last resort.--In carrying out its
responsibilities to ensure access to services or programs
under this subsection, the State agency shall not be
considered to be a legally liable third party for purposes of
satisfying a financial commitment for the cost of providing
such services or programs with respect to any individual for
whom such cost would have been paid for from another public
or private source but for the enactment of this subsection
(except that whenever considered necessary to prevent a delay
in the receipt of appropriate early intervention services by
a child or family in a timely fashion, funds provided under
section 474(a)(6) may be used to pay the provider of services
or programs pending reimbursement from the public or private
source that has ultimate responsibility for the payment).''.
(c) Effective Date.--The amendments made by subsection (b)
shall take effect as if included in section 50711 of division
E of Public Law 115-123.
SEC. 2303. BUILDING CAPACITY FOR FAMILY-FOCUSED RESIDENTIAL
TREATMENT.
(a) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means a
State, county, local, or tribal health or child welfare
agency, a private nonprofit organization, a research
organization, a treatment service provider, an institution of
higher education (as defined under section 101 of the Higher
Education Act of 1965 (20 U.S.C. 1001)), or another entity
specified by the Secretary.
(2) Family-focused residential treatment program.--The term
``family-focused residential treatment program'' means a
trauma-informed residential program primarily for substance
use disorder treatment for pregnant and postpartum women and
parents and guardians that allows children to reside with
such women or their parents or guardians during treatment to
the extent appropriate and applicable.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Support for the Development of Evidence-based Family-
focused Residential Treatment Programs.--
(1) Authority to award grants.--The Secretary shall award
grants to eligible entities for purposes of developing,
enhancing, or evaluating family-focused residential treatment
programs to increase the availability of such programs that
meet the requirements for promising, supported, or well-
supported practices specified in section 471(e)(4)(C) of the
Social Security Act (42 U.S.C. 671(e)(4)(C))) (as added by
the Family First Prevention Services Act enacted under title
VII of division E of Public Law 115-123).
(2) Evaluation requirement.--The Secretary shall require
any evaluation of a family-focused residential treatment
program by an eligible entity that uses funds awarded under
this section for all or part of the costs of the evaluation
be designed to assist in the determination of whether the
program may qualify as a promising, supported, or well-
supported practice in accordance with the requirements of
such section 471(e)(4)(C).
(c) Authorization of Appropriations.--There is authorized
to be appropriated to the Secretary to carry out this
section, $20,000,000 for fiscal year 2019, which shall remain
available through fiscal year 2023.
Subtitle D--Synthetics Trafficking and Overdose Prevention
SEC. 2401. SHORT TITLE.
This subtitle may be cited as the ``Synthetics Trafficking
and Overdose Prevention Act of 2018'' or ``STOP Act of
2018''.
SEC. 2402. CUSTOMS FEES.
(a) In General.--Section 13031(b)(9) of the Consolidated
Omnibus Budget Reconciliation Act of 1985 (19 U.S.C.
58c(b)(9)) is amended by adding at the end the following:
``(D)(i) With respect to the processing of items that are
sent to the United States through the international postal
network by `Inbound Express Mail service' or `Inbound EMS'
(as that service is described in the mail classification
schedule referred to in section 3631 of title 39, United
States Code), the following payments are required:
``(I) $1 per Inbound EMS item.
``(II) If an Inbound EMS item is formally entered, the fee
provided for under subsection (a)(9), if applicable.
``(ii) Notwithstanding section 451 of the Tariff Act of
1930 (19 U.S.C. 1451), the payments required by clause (i),
as allocated pursuant to clause (iii)(I), shall be the only
payments required for reimbursement of U.S. Customs and
Border Protection for customs services provided in connection
with the processing of an Inbound EMS item.
``(iii)(I) The payments required by clause (i)(I) shall be
allocated as follows:
``(aa) 50 percent of the amount of the payments shall be
paid on a quarterly basis by the United States Postal Service
to the Commissioner of U.S. Customs and Border Protection in
accordance with regulations prescribed by the Secretary of
the Treasury to reimburse U.S. Customs and Border Protection
for customs services provided in connection with the
processing of Inbound EMS items.
``(bb) 50 percent of the amount of the payments shall be
retained by the Postal Service to reimburse the Postal
Service for services provided in connection with the customs
processing of Inbound EMS items.
``(II) Payments received by U.S. Customs and Border
Protection under subclause (I)(aa) shall, in accordance with
section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be
deposited in the Customs User Fee Account and used to
directly reimburse each appropriation for the amount paid out
of that appropriation for the costs incurred in providing
services to international mail facilities. Amounts deposited
in accordance with the preceding sentence shall be available
until expended for the provision of such services.
``(III) Payments retained by the Postal Service under
subclause (I)(bb) shall be used to directly reimburse the
Postal Service for the costs incurred in providing services
in connection with the customs processing of Inbound EMS
items.
``(iv) Beginning in fiscal year 2021, the Secretary, in
consultation with the Postmaster General, may adjust, not
more frequently than once each fiscal year, the amount
described in clause (i)(I) to an amount commensurate with the
costs of services provided in connection with the customs
processing of Inbound EMS items, consistent with the
obligations of the United States under international
agreements.''.
(b) Conforming Amendments.--Section 13031(a) of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (19
U.S.C. 58c(a)) is amended--
(1) in paragraph (6), by inserting ``(other than an item
subject to a fee under subsection (b)(9)(D))'' after
``customs officer''; and
(2) in paragraph (10)--
(A) in subparagraph (C), in the matter preceding clause
(i), by inserting ``(other than Inbound EMS items described
in subsection (b)(9)(D))'' after ``release''; and
(B) in the flush at the end, by inserting ``or of Inbound
EMS items described in subsection (b)(9)(D),'' after
``(C),''.
(c) Effective Date.--The amendments made by this section
shall take effect on January 1, 2020.
SEC. 2403. MANDATORY ADVANCE ELECTRONIC INFORMATION FOR
POSTAL SHIPMENTS.
(a) Mandatory Advance Electronic Information.--
(1) In general.--Section 343(a)(3)(K) of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended to
read as follows:
``(K)(i) The Secretary shall prescribe regulations
requiring the United States Postal Service to transmit the
information described in paragraphs (1) and (2) to the
Commissioner of U.S. Customs and Border Protection for
international mail shipments by the Postal Service (including
shipments to the Postal Service from foreign postal operators
that are transported by private carrier) consistent with the
requirements of this subparagraph.
``(ii) In prescribing regulations under clause (i), the
Secretary shall impose requirements for the transmission to
the Commissioner of information described in paragraphs (1)
and (2) for mail shipments described in clause (i) that are
comparable to the requirements for the transmission of such
information imposed on similar non-mail shipments of cargo,
taking into account the parameters set forth in subparagraphs
(A) through (J).
``(iii) The regulations prescribed under clause (i) shall
require the transmission of the information described in
paragraphs (1) and (2) with respect to a shipment as soon as
practicable in relation to the transportation
[[Page S6092]]
of the shipment, consistent with subparagraph (H).
``(iv) Regulations prescribed under clause (i) shall allow
for the requirements for the transmission to the Commissioner
of information described in paragraphs (1) and (2) for mail
shipments described in clause (i) to be implemented in
phases, as appropriate, by--
``(I) setting incremental targets for increasing the
percentage of such shipments for which information is
required to be transmitted to the Commissioner; and
``(II) taking into consideration--
``(aa) the risk posed by such shipments;
``(bb) the volume of mail shipped to the United States by
or through a particular country; and
``(cc) the capacities of foreign postal operators to
provide that information to the Postal Service.
``(v)(I) Notwithstanding clause (iv), the Postal Service
shall, not later than December 31, 2018, arrange for the
transmission to the Commissioner of the information described
in paragraphs (1) and (2) for not less than 70 percent of the
aggregate number of mail shipments, including 100 percent of
mail shipments from the People's Republic of China, described
in clause (i).
``(II) If the requirements of subclause (I) are not met,
the Comptroller General of the United States shall submit to
the appropriate congressional committees, not later than June
30, 2019, a report--
``(aa) assessing the reasons for the failure to meet those
requirements; and
``(bb) identifying recommendations to improve the
collection by the Postal Service of the information described
in paragraphs (1) and (2).
``(vi)(I) Notwithstanding clause (iv), the Postal Service
shall, not later than December 31, 2020, arrange for the
transmission to the Commissioner of the information described
in paragraphs (1) and (2) for 100 percent of the aggregate
number of mail shipments described in clause (i).
``(II) The Commissioner, in consultation with the
Postmaster General, may determine to exclude a country from
the requirement described in subclause (I) to transmit
information for mail shipments described in clause (i) from
the country if the Commissioner determines that the country--
``(aa) does not have the capacity to collect and transmit
such information;
``(bb) represents a low risk for mail shipments that
violate relevant United States laws and regulations; and
``(cc) accounts for low volumes of mail shipments that can
be effectively screened for compliance with relevant United
States laws and regulations through an alternate means.
``(III) The Commissioner shall, at a minimum on an annual
basis, re-evaluate any determination made under subclause
(II) to exclude a country from the requirement described in
subclause (I). If, at any time, the Commissioner determines
that a country no longer meets the requirements under
subclause (II), the Commissioner may not further exclude the
country from the requirement described in subclause (I).
``(IV) The Commissioner shall, on an annual basis, submit
to the appropriate congressional committees--
``(aa) a list of countries with respect to which the
Commissioner has made a determination under subclause (II) to
exclude the countries from the requirement described in
subclause (I); and
``(bb) information used to support such determination with
respect to such countries.
``(vii)(I) The Postmaster General shall, in consultation
with the Commissioner, refuse any shipments received after
December 31, 2020, for which the information described in
paragraphs (1) and (2) is not transmitted as required under
this subparagraph, except as provided in subclause (II).
``(II) If remedial action is warranted in lieu of refusal
of shipments pursuant to subclause (I), the Postmaster
General and the Commissioner shall take remedial action with
respect to the shipments, including destruction, seizure,
controlled delivery or other law enforcement initiatives, or
correction of the failure to provide the information
described in paragraphs (1) and (2) with respect to the
shipment.
``(viii) Nothing in this subparagraph shall be construed to
limit the authority of the Secretary to obtain information
relating to international mail shipments from private
carriers or other appropriate parties.
``(ix) In this subparagraph, the term `appropriate
congressional committees' means--
``(I) the Committee on Finance and the Committee on
Homeland Security and Governmental Affairs of the Senate; and
``(II) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.''.
(2) Joint strategic plan on mandatory advance
information.--Not later than 60 days after the date of the
enactment of this Act, the Secretary of Homeland Security and
the Postmaster General shall develop and submit to the
appropriate congressional committees a joint strategic plan
detailing specific performance measures for achieving--
(A) the transmission of information as required by section
343(a)(3)(K) of the Trade Act of 2002, as amended by
paragraph (1); and
(B) the presentation by the Postal Service to U.S. Customs
and Border Protection of all mail targeted by U.S. Customs
and Border Protection for inspection.
(b) Capacity Building.--
(1) In general.--Section 343(a) of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended by
adding at the end the following:
``(5) Capacity building.--
``(A) In general.--The Secretary, with the concurrence of
the Secretary of State, and in coordination with the
Postmaster General and the heads of other Federal agencies,
as appropriate, may provide technical assistance, equipment,
technology, and training to enhance the capacity of foreign
postal operators--
``(i) to gather and provide the information required by
paragraph (3)(K); and
``(ii) to otherwise gather and provide postal shipment
information related to--
``(I) terrorism;
``(II) items the importation or introduction of which into
the United States is prohibited or restricted, including
controlled substances; and
``(III) such other concerns as the Secretary determines
appropriate.
``(B) Provision of equipment and technology.--With respect
to the provision of equipment and technology under
subparagraph (A), the Secretary may lease, loan, provide, or
otherwise assist in the deployment of such equipment and
technology under such terms and conditions as the Secretary
may prescribe, including nonreimbursable loans or the
transfer of ownership of equipment and technology.''.
(2) Joint strategic plan on capacity building.--Not later
than one year after the date of the enactment of this Act,
the Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
develop and submit to the appropriate congressional
committees a joint strategic plan--
(A) detailing the extent to which U.S. Customs and Border
Protection and the United States Postal Service are engaged
in capacity building efforts under section 343(a)(5) of the
Trade Act of 2002, as added by paragraph (1);
(B) describing plans for future capacity building efforts;
and
(C) assessing how capacity building has increased the
ability of U.S. Customs and Border Protection and the Postal
Service to advance the goals of this subtitle and the
amendments made by this subtitle.
(c) Report and Consultations by Secretary of Homeland
Security and Postmaster General.--
(1) Report.--Not later than 180 days after the date of the
enactment of this Act, and annually thereafter until 3 years
after the Postmaster General has met the requirement under
clause (vi) of subparagraph (K) of section 343(a)(3) of the
Trade Act of 2002, as amended by subsection (a)(1), the
Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
submit to the appropriate congressional committees a report
on compliance with that subparagraph that includes the
following:
(A) An assessment of the status of the regulations required
to be promulgated under that subparagraph.
(B) An update regarding new and existing agreements reached
with foreign postal operators for the transmission of the
information required by that subparagraph.
(C) A summary of deliberations between the United States
Postal Service and foreign postal operators with respect to
issues relating to the transmission of that information.
(D) A summary of the progress made in achieving the
transmission of that information for the percentage of
shipments required by that subparagraph.
(E) An assessment of the quality of that information being
received by foreign postal operators, as determined by the
Secretary of Homeland Security, and actions taken to improve
the quality of that information.
(F) A summary of policies established by the Universal
Postal Union that may affect the ability of the Postmaster
General to obtain the transmission of that information.
(G) A summary of the use of technology to detect illicit
synthetic opioids and other illegal substances in
international mail parcels and planned acquisitions and
advancements in such technology.
(H) Such other information as the Secretary of Homeland
Security and the Postmaster General consider appropriate with
respect to obtaining the transmission of information required
by that subparagraph.
(2) Consultations.--Not later than 180 days after the date
of the enactment of this Act, and every 180 days thereafter
until the Postmaster General has met the requirement under
clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002,
as amended by subsection (a)(1), to arrange for the
transmission of information with respect to 100 percent of
the aggregate number of mail shipments described in clause
(i) of that section, the Secretary of Homeland Security and
the Postmaster General shall provide briefings to the
appropriate congressional committees on the progress made in
achieving the transmission of that information for that
percentage of shipments.
(d) Government Accountability Office Report.--Not later
than June 30, 2019, the Comptroller General of the United
States shall submit to the appropriate congressional
committees a report--
(1) assessing the progress of the United States Postal
Service in achieving the transmission of the information
required by subparagraph (K) of section 343(a)(3) of the
[[Page S6093]]
Trade Act of 2002, as amended by subsection (a)(1), for the
percentage of shipments required by that subparagraph;
(2) assessing the quality of the information received from
foreign postal operators for targeting purposes;
(3) assessing the specific percentage of targeted mail
presented by the Postal Service to U.S. Customs and Border
Protection for inspection;
(4) describing the costs of collecting the information
required by such subparagraph (K) from foreign postal
operators and the costs of implementing the use of that
information;
(5) assessing the benefits of receiving that information
with respect to international mail shipments;
(6) assessing the feasibility of assessing a customs fee
under section 13031(b)(9) of the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended by section 2402, on
international mail shipments other than Inbound Express Mail
service in a manner consistent with the obligations of the
United States under international agreements; and
(7) identifying recommendations, including recommendations
for legislation, to improve the compliance of the Postal
Service with such subparagraph (K), including an assessment
of whether the detection of illicit synthetic opioids in the
international mail would be improved by--
(A) requiring the Postal Service to serve as the consignee
for international mail shipments containing goods; or
(B) designating a customs broker to act as an importer of
record for international mail shipments containing goods.
(e) Technical Correction.--Section 343 of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended in
the section heading by striking ``advanced'' and inserting
``advance''.
(f) Appropriate Congressional Committees Defined.--In this
section, the term ``appropriate congressional committees''
means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.
SEC. 2404. INTERNATIONAL POSTAL AGREEMENTS.
(a) Existing Agreements.--
(1) In general.--In the event that any provision of this
subtitle, or any amendment made by this subtitle, is
determined to be in violation of obligations of the United
States under any postal treaty, convention, or other
international agreement related to international postal
services, or any amendment to such an agreement, the
Secretary of State should negotiate to amend the relevant
provisions of the agreement so that the United States is no
longer in violation of the agreement.
(2) Rule of construction.--Nothing in this subsection shall
be construed to permit delay in the implementation of this
subtitle or any amendment made by this subtitle.
(b) Future Agreements.--
(1) Consultations.--Before entering into, on or after the
date of the enactment of this Act, any postal treaty,
convention, or other international agreement related to
international postal services, or any amendment to such an
agreement, that is related to the ability of the United
States to secure the provision of advance electronic
information by foreign postal operators, the Secretary of
State should consult with the appropriate congressional
committees (as defined in section 2403(f)).
(2) Expedited negotiation of new agreement.--To the extent
that any new postal treaty, convention, or other
international agreement related to international postal
services would improve the ability of the United States to
secure the provision of advance electronic information by
foreign postal operators as required by regulations
prescribed under section 343(a)(3)(K) of the Trade Act of
2002, as amended by section 2403(a)(1), the Secretary of
State should expeditiously conclude such an agreement.
SEC. 2405. COST RECOUPMENT.
(a) In General.--The United States Postal Service shall, to
the extent practicable and otherwise recoverable by law,
ensure that all costs associated with complying with this
subtitle and amendments made by this subtitle are charged
directly to foreign shippers or foreign postal operators.
(b) Costs Not Considered Revenue.--The recovery of costs
under subsection (a) shall not be deemed revenue for purposes
of subchapter I and II of chapter 36 of title 39, United
States Code, or regulations prescribed under that chapter.
SEC. 2406. DEVELOPMENT OF TECHNOLOGY TO DETECT ILLICIT
NARCOTICS.
(a) In General.--The Postmaster General and the
Commissioner of U.S. Customs and Border Protection, in
coordination with the heads of other agencies as appropriate,
shall collaborate to identify and develop technology for the
detection of illicit fentanyl, other synthetic opioids, and
other narcotics and psychoactive substances entering the
United States by mail.
(b) Outreach to Private Sector.--The Postmaster General and
the Commissioner shall conduct outreach to private sector
entities to gather information regarding the current state of
technology to identify areas for innovation relating to the
detection of illicit fentanyl, other synthetic opioids, and
other narcotics and psychoactive substances entering the
United States.
SEC. 2407. CIVIL PENALTIES FOR POSTAL SHIPMENTS.
Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is
amended by adding at the end the following new subsection:
``(e) Civil Penalties for Postal Shipments.--
``(1) Civil penalty.--A civil penalty shall be imposed
against the United States Postal Service if the Postal
Service accepts a shipment in violation of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002.
``(2) Modification of civil penalty.--
``(A) In general.--U.S. Customs and Border Protection shall
reduce or dismiss a civil penalty imposed pursuant to
paragraph (1) if U.S. Customs and Border Protection
determines that the United States Postal Service--
``(i) has a low error rate in compliance with section
343(a)(3)(K) of the Trade Act of 2002;
``(ii) is cooperating with U.S. Customs and Border
Protection with respect to the violation of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or
``(iii) has taken remedial action to prevent future
violations of section 343(a)(3)(K)(vii)(I) of the Trade Act
of 2002.
``(B) Written notification.--U.S. Customs and Border
Protection shall issue a written notification to the Postal
Service with respect to each exercise of the authority of
subparagraph (A) to reduce or dismiss a civil penalty imposed
pursuant to paragraph (1).
``(3) Ongoing lack of compliance.--If U.S. Customs and
Border Protection determines that the United States Postal
Service--
``(A) has repeatedly committed violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002,
``(B) has failed to cooperate with U.S. Customs and Border
Protection with respect to violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and
``(C) has an increasing error rate in compliance with
section 343(a)(3)(K) of the Trade Act of 2002,
civil penalties may be imposed against the United States
Postal Service until corrective action, satisfactory to U.S.
Customs and Border Protection, is taken.''.
SEC. 2408. REPORT ON VIOLATIONS OF ARRIVAL, REPORTING, ENTRY,
AND CLEARANCE REQUIREMENTS AND FALSITY OR LACK
OF MANIFEST.
(a) In General.--The Commissioner of U.S. Customs and
Border Protection shall submit to the appropriate
congressional committees an annual report that contains the
information described in subsection (b) with respect to each
violation of section 436 of the Tariff Act of 1930 (19 U.S.C.
1436), as amended by section 7, and section 584 of such Act
(19 U.S.C. 1584) that occurred during the previous year.
(b) Information Described.--The information described in
this subsection is the following:
(1) The name and address of the violator.
(2) The specific violation that was committed.
(3) The location or port of entry through which the items
were transported.
(4) An inventory of the items seized, including a
description of the items and the quantity seized.
(5) The location from which the items originated.
(6) The entity responsible for the apprehension or seizure,
organized by location or port of entry.
(7) The amount of penalties assessed by U.S. Customs and
Border Protection, organized by name of the violator and
location or port of entry.
(8) The amount of penalties that U.S. Customs and Border
Protection could have levied, organized by name of the
violator and location or port of entry.
(9) The rationale for negotiating lower penalties,
organized by name of the violator and location or port of
entry.
(c) Appropriate Congressional Committees Defined.--In this
section, the term ``appropriate congressional committees''
means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.
SEC. 2409. EFFECTIVE DATE; REGULATIONS.
(a) Effective Date.--This subtitle and the amendments made
by this subtitle (other than the amendments made by section
2402) shall take effect on the date of the enactment of this
Act.
(b) Regulations.--Not later than one year after the date of
the enactment of this Act, such regulations as are necessary
to carry out this subtitle and the amendments made by this
subtitle shall be prescribed.
TITLE III--JUDICIARY
Subtitle A--Access to Increased Drug Disposal
SEC. 3101. SHORT TITLE.
This subtitle may be cited as the ``Access to Increased
Drug Disposal Act of 2018''.
SEC. 3102. DEFINITIONS.
In this subtitle--
(1) the term ``Attorney General'' means the Attorney
General, acting through the Assistant Attorney General for
the Office of Justice Programs;
(2) the term ``authorized collector'' means a narcotic
treatment program, a hospital or
[[Page S6094]]
clinic with an on-site pharmacy, a retail pharmacy, or a
reverse distributor, that is authorized as a collector under
section 1317.40 of title 21, Code of Federal Regulations (or
any successor regulation);
(3) the term ``covered grant'' means a grant awarded under
section 3003; and
(4) the term ``eligible collector'' means a person who is
eligible to be an authorized collector.
SEC. 3103. AUTHORITY TO MAKE GRANTS.
The Attorney General shall award grants to States to enable
the States to increase the participation of eligible
collectors as authorized collectors.
SEC. 3104. APPLICATION.
A State desiring a covered grant shall submit to the
Attorney General an application that, at a minimum--
(1) identifies the single State agency that oversees
pharmaceutical care and will be responsible for complying
with the requirements of the grant;
(2) details a plan to increase participation rates of
eligible collectors as authorized collectors; and
(3) describes how the State will select eligible collectors
to be served under the grant.
SEC. 3105. USE OF GRANT FUNDS.
A State that receives a covered grant, and any subrecipient
of the grant, may use the grant amounts only for the costs of
installation, maintenance, training, purchasing, and disposal
of controlled substances associated with the participation of
eligible collectors as authorized collectors.
SEC. 3106. ELIGIBILITY FOR GRANT.
The Attorney General shall award a covered grant to 5
States, not less than 3 of which shall be States in the
lowest quartile of States based on the participation rate of
eligible collectors as authorized collectors, as determined
by the Attorney General.
SEC. 3107. DURATION OF GRANTS.
The Attorney General shall determine the period of years
for which a covered grant is made to a State.
SEC. 3108. ACCOUNTABILITY AND OVERSIGHT.
A State that receives a covered grant shall submit to the
Attorney General a report, at such time and in such manner as
the Attorney General may reasonably require, that--
(1) lists the ultimate recipients of the grant amounts;
(2) describes the activities undertaken by the State using
the grant amounts; and
(3) contains performance measures relating to the
effectiveness of the grant, including changes in the
participation rate of eligible collectors as authorized
collectors.
SEC. 3109. DURATION OF PROGRAM.
The Attorney General may award covered grants for each of
the first 5 fiscal years beginning after the date of
enactment of this Act.
SEC. 3110. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to the Attorney
General such sums as may be necessary to carry out this
subtitle.
Subtitle B--Using Data To Prevent Opioid Diversion
SEC. 3201. SHORT TITLE.
This subtitle may be cited as the ``Using Data to Prevent
Opioid Diversion Act of 2018''.
SEC. 3202. PURPOSE.
(a) In General.--The purpose of this subtitle is to provide
drug manufacturers and distributors with access to anonymized
information through the Automated Reports and Consolidated
Orders System to help drug manufacturers and distributors
identify, report, and stop suspicious orders of opioids and
reduce diversion rates.
(b) Rule of Construction.--Nothing in this subtitle should
be construed to absolve a drug manufacturer, drug
distributor, or other Drug Enforcement Administration
registrant from the responsibility of the manufacturer,
distributor, or other registrant to--
(1) identify, stop, and report suspicious orders; or
(2) maintain effective controls against diversion in
accordance with section 303 of the Controlled Substances Act
(21 U.S.C. 823) or any successor law or associated
regulation.
SEC. 3203. AMENDMENTS.
(a) Records and Reports of Registrants.--Section 307 of the
Controlled Substances Act (21 U.S.C. 827) is amended--
(1) by redesignating subsections (f), (g), and (h) as
subsections (g), (h), and (i), respectively;
(2) by inserting after subsection (e) the following:
``(f)(1) The Attorney General shall, not less frequently
than quarterly, make the following information available to
manufacturer and distributor registrants through the
Automated Reports and Consolidated Orders System, or any
subsequent automated system developed by the Drug Enforcement
Administration to monitor selected controlled substances:
``(A) The total number of distributor registrants that
distribute controlled substances to a pharmacy or
practitioner registrant, aggregated by the name and address
of each pharmacy and practitioner registrant.
``(B) The total quantity and type of opioids distributed,
listed by Administration Controlled Substances Code Number,
to each pharmacy and practitioner registrant described in
subparagraph (A).
``(2) The information required to be made available under
paragraph (1) shall be made available not later than the 15th
day of the first month following the quarter to which the
information relates.
``(3)(A) All registered manufacturers and distributors
shall be responsible for reviewing the information made
available by the Attorney General under this subsection.
``(B) In determining whether to initiate proceedings under
this title against a registered manufacturer or distributor
based on the failure of the registrant to maintain effective
controls against diversion or otherwise comply with the
requirements of this title or the regulations issued
thereunder, the Attorney General may take into account that
the information made available under this subsection was
available to the registrant.''; and
(3) by inserting after subsection (i), as so redesignated,
the following:
``(j) All of the reports required under this section shall
be provided in an electronic format.''.
(b) Cooperative Arrangements.--Section 503 of the
Controlled Substances Act (21 U.S.C. 873) is amended--
(1) by striking subsection (c) and inserting the following:
``(c)(1) The Attorney General shall, once every 6 months,
prepare and make available to regulatory, licensing,
attorneys general, and law enforcement agencies of States a
standardized report containing descriptive and analytic
information on the actual distribution patterns, as gathered
through the Automated Reports and Consolidated Orders System,
or any subsequent automated system, pursuant to section 307
and which includes detailed amounts, outliers, and trends of
distributor and pharmacy registrants, in such States for the
controlled substances contained in schedule II, which, in the
discretion of the Attorney General, are determined to have
the highest abuse.
``(2) If the Attorney General publishes the report
described in paragraph (1) once every 6 months as required
under paragraph (1), nothing in this subsection shall be
construed to bring an action in any court to challenge the
sufficiency of the information or to compel the Attorney
General to produce any documents or reports referred to in
this subsection.''.
(c) Civil and Criminal Penalties.--Section 402 of the
Controlled Substances Act (21 U.S.C. 842) is amended--
(1) in subsection (a)--
(A) in paragraph (15), by striking ``or'' at the end;
(B) in paragraph (16), by striking the period at the end
and inserting ``; or''; and
(C) by inserting after paragraph (16) the following:
``(17) in the case of a registered manufacturer or
distributor of opioids, to fail to review the most recent
information, directly related to the customers of the
manufacturer or distributor, made available by the Attorney
General in accordance with section 307(f).''; and
(2) in subsection (c)--
(A) in paragraph (1), by striking subparagraph (B) and
inserting the following:
``(B)(i) Except as provided in clause (ii), in the case of
a violation of paragraph (5), (10), or (17) of subsection
(a), the penalty shall not exceed $10,000.
``(ii) In the case of a violation described in clause (i)
committed by a registered manufacturer or distributor of
opioids and related to the reporting of suspicious orders for
opioids, failing to maintain effective controls against
diversion of opioids, or failing to review the most recent
information made available by the Attorney General in
accordance with section 307(f), the penalty shall not exceed
$100,000.''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``or (D)'' after
``subparagraph (B)''; and
(ii) by adding at the end the following:
``(D) In the case of a violation described in subparagraph
(A) that was a violation of paragraph (5), (10), or (17) of
subsection (a) committed by a registered manufacturer or
distributor of opioids that relates to the reporting of
suspicious orders for opioids, failing to maintain effective
controls against diversion of opioids, or failing to review
the most recent information made available by the Attorney
General in accordance with section 307(f), the criminal fine
under title 18, United States Code, shall not exceed
$500,000.''.
SEC. 3204. REPORT.
Not later than 1 year after the date of enactment of this
Act, the Attorney General shall submit to Congress a report
that provides information about how the Attorney General is
using data in the Automation of Reports and Consolidated
Orders System to identify and stop suspicious activity,
including whether the Attorney General is looking at
aggregate orders from individual pharmacies to multiple
distributors that in total are suspicious, even if no
individual order rises to the level of a suspicious order to
a given distributor.
Subtitle C--Substance Abuse Prevention
SEC. 3301. SHORT TITLE.
This subtitle may be cited as the ``Substance Abuse
Prevention Act of 2018''.
SEC. 3302. REAUTHORIZATION OF THE OFFICE OF NATIONAL DRUG
CONTROL POLICY.
(a) Office of National Drug Control Policy Reauthorization
Act of 1998.--
(1) In general.--The Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.), as in
effect on September 29, 2003, and as amended by the laws
described in paragraph (2), is revived and restored.
(2) Laws described.--The laws described in this paragraph
are:
[[Page S6095]]
(A) The Office of National Drug Control Policy
Reauthorization Act of 2006 (Public Law 109-469; 120 Stat.
3502).
(B) The Presidential Appointment Efficiency and
Streamlining Act of 2011 (Public Law 112-166; 126 Stat.
1283).
(b) Reauthorization.--Section 715(a) of the Office of
National Drug Control Policy Reauthorization Act of 1998 (21
U.S.C. 1712(a)) is amended by striking ``2010'' and inserting
``2022''.
SEC. 3303. REAUTHORIZATION OF THE DRUG-FREE COMMUNITIES
PROGRAM.
Section 1024 of the National Narcotics Leadership Act of
1988 (21 U.S.C. 1524(a)) is amended by striking subsections
(a) and (b) and inserting the following:
``(a) In General.--There is authorized to be appropriated
to the Office of National Drug Control Policy to carry out
this chapter $99,000,000 for each of fiscal years 2018
through 2022.
``(b) Administrative Costs.--Not more than 8 percent of the
funds appropriated to carry out this chapter may be used by
the Office of National Drug Control Policy to pay
administrative costs associated with the responsibilities of
the Office under this chapter.''.
SEC. 3304. REAUTHORIZATION OF THE NATIONAL COMMUNITY ANTI-
DRUG COALITION INSTITUTE.
Section 4(c)(4) of Public Law 107-82 (21 U.S.C. 1521 note)
is amended by striking ``2008 through 2012'' and inserting
``2018 through 2022''.
SEC. 3305. REAUTHORIZATION OF THE HIGH-INTENSITY DRUG
TRAFFICKING AREA PROGRAM.
Section 707(p) of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1706(p)) is
amended--
(1) in paragraph (4), by striking ``and'' at the end;
(2) in paragraph (5), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(6) $280,000,000 for each of fiscal years 2018 through
2022.''.
SEC. 3306. REAUTHORIZATION OF DRUG COURT PROGRAM.
Section 1001(a)(25)(A) of title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (34 U.S.C.
10261(a)(25)(A)) is amended by striking ``Except as
provided'' and all that follows and inserting the following:
``Except as provided in subparagraph (C), there is authorized
to be appropriated to carry out part EE $75,000,000 for each
of fiscal years 2018 through 2022.''.
SEC. 3307. DRUG COURT TRAINING AND TECHNICAL ASSISTANCE.
Section 705 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1704) is amended by
adding at the end the following--
``(e) Drug Court Training and Technical Assistance
Program.--Using funds appropriated to carry out this title,
the Director may make grants to nonprofit organizations for
the purpose of providing training and technical assistance to
drug courts.''.
SEC. 3308. DRUG OVERDOSE RESPONSE STRATEGY.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706) is amended by
adding at the end the following:
``(r) Drug Overdose Response Strategy Implementation.--The
Director may use funds appropriated to carry out this section
to implement a drug overdose response strategy in high
intensity drug trafficking areas on a nationwide basis by--
``(1) coordinating multi-disciplinary efforts to prevent,
reduce, and respond to drug overdoses, including the uniform
reporting of fatal and non-fatal overdoses to public health
and safety officials;
``(2) increasing data sharing among public safety and
public health officials concerning drug-related abuse trends,
including new psychoactive substances, and related crime; and
``(3) enabling collaborative deployment of prevention,
intervention, and enforcement resources to address substance
use addiction and narcotics trafficking.''.
SEC. 3309. PROTECTING LAW ENFORCEMENT OFFICERS FROM
ACCIDENTAL EXPOSURE.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706), as amended by
section 3308, is amended by adding at the end the following:
``(s) Supplemental Grants.--The Director is authorized to
use not more than $10,000,000 of the amounts otherwise
appropriated to carry out this section to provide
supplemental competitive grants to high intensity drug
trafficking areas that have experienced high seizures of
fentanyl and new psychoactive substances for the purposes
of--
``(1) purchasing portable equipment to test for fentanyl
and other substances;
``(2) training law enforcement officers and other first
responders on best practices for handling fentanyl and other
substances; and
``(3) purchasing protective equipment, including overdose
reversal drugs.''.
SEC. 3310. COPS ANTI-METH PROGRAM.
Section 1701 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (34 U.S.C. 10381) is amended--
(1) by redesignating subsection (k) as subsection (l); and
(2) by inserting after subsection (j) the following:
``(k) COPS Anti-Meth Program.--The Attorney General shall
use amounts otherwise appropriated to carry out this section
to make competitive grants, in amounts of not less than
$1,000,000 for a fiscal year, to State law enforcement
agencies with high seizures of precursor chemicals, finished
methamphetamine, laboratories, and laboratory dump seizures
for the purpose of locating or investigating illicit
activities, such as precursor diversion, laboratories, or
methamphetamine traffickers.''.
SEC. 3311. COPS ANTI-HEROIN TASK FORCE PROGRAM.
Section 1701 of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (34 U.S.C. 10381) is amended--
(1) by redesignating subsection (l), as so redesignated by
section 3310, as subsection (m); and
(2) by inserting after subsection (k), as added by section
3310, the following:
``(l) Cops Anti-heroin Task Force Program.--The Attorney
General shall use amounts otherwise appropriated to carry out
this section, or other amounts as appropriated, to make
competitive grants to State law enforcement agencies in
States with high per capita rates of primary treatment
admissions, for the purpose of locating or investigating
illicit activities, through Statewide collaboration, relating
to the distribution of heroin, fentanyl, or carfentanil or
relating to the unlawful distribution of prescription
opioids.''.
SEC. 3312. COMPREHENSIVE ADDICTION AND RECOVERY ACT EDUCATION
AND AWARENESS.
Title VII of the Comprehensive Addiction and Recovery Act
of 2016 (Public Law 114-198; 130 Stat. 735) is amended by
adding at the end the following:
``SEC. 709. SERVICES FOR FAMILIES AND PATIENTS IN CRISIS.
``(a) In General.--The Attorney General may make grants to
entities that focus on addiction and substance use disorders
and specialize in family and patient services, advocacy for
patients and families, and educational information.
``(b) Allowable Uses.--A grant awarded under this section
may be used for private, nonprofit national organizations
that engage in all of the following activities:
``(1) Expansion of phone line or call center services with
professional, clinical staff that provide, for families and
individuals impacted by a substance use disorder, support,
access to treatment resources, brief assessments, medication
and overdose prevention education, compassionate listening
services, recovery support or peer specialists, bereavement
and grief support, and case management.
``(2) Continued development of health information
technology systems that leverage new and upcoming technology
and techniques for prevention, intervention, and filling
resource gaps in communities that are underserved.
``(3) Enhancement and operation of treatment and recovery
resources, easy-to-read scientific and evidence-based
education on addiction and substance use disorders, and other
informational tools for families and individuals impacted by
a substance use disorder and community stakeholders, such as
law enforcement agencies.
``(4) Provision of training and technical assistance to
State and local governments, law enforcement agencies, health
care systems, research institutions, and other stakeholders.
``(5) Expanding upon and implementing educational
information using evidence-based information on substance use
disorders.
``(6) Expansion of training of community stakeholders, law
enforcement officers, and families across a broad-range of
addiction, health, and related topics on substance use
disorders, local issues and community-specific issues related
to the drug epidemic.
``(7) Program evaluation.
``(c) Authorization of Appropriations.--For each of fiscal
years 2018 through 2022, the Attorney General is authorized
to award not more than $10,000,000 of amounts otherwise
appropriated to the Attorney General for comprehensive opioid
abuse reduction activities for purposes of carrying out this
section.''.
SEC. 3313. PROTECTING CHILDREN WITH ADDICTED PARENTS.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.) is amended by adding at the end the
following:
``SEC. 550. PROTECTING CHILDREN WITH ADDICTED PARENTS.
``(a) Best Practices.--The Secretary, acting through the
Assistant Secretary and in cooperation with the Commissioner
of the Administration on Children, Youth and Families, shall
collect and disseminate best practices for States regarding
interventions and strategies to keep families affected by a
substance use disorder together, when it can be done safely.
Such best practices shall--
``(1) utilize comprehensive family-centered approaches;
``(2) ensure that families have access to drug screening,
substance use disorder treatment, medication-assisted
treatment approved by the Food and Drug Administration, and
parental support; and
``(3) build upon lessons learned from--
``(A) programs such as the maternal, infant, and early
childhood home visiting program under section 511 of the
Social Security Act; and
``(B) identifying substance abuse prevention and treatment
services that meet the requirements for promising, supported,
or
[[Page S6096]]
well-supported practices specified in section 471(e)(4)(C) of
the Social Security Act (as such section shall be in effect
beginning on October 1, 2018).
``(b) Grant Program.--The Secretary shall award grants to
States, units of local government, and tribal governments
to--
``(1) develop programs and models designed to keep pregnant
and post-partum women who have a substance use disorder
together with their newborns, including programs and models
that provide for screenings of pregnant and post-partum women
for substance use disorders, treatment interventions,
supportive housing, nonpharmacological interventions for
children born with neonatal abstinence syndrome, medication
assisted treatment, and other recovery supports; and
``(2) support the attendance of children who have a family
member living with a substance use disorder at therapeutic
camps or other therapeutic programs aimed at addiction
prevention education and delaying the onset of first use,
providing trusted mentors and education on coping strategies
that these children can use in their daily lives, and family
support initiatives aimed at keeping these families
together.''.
SEC. 3314. REIMBURSEMENT OF SUBSTANCE USE DISORDER TREATMENT
PROFESSIONALS.
Not later than January 1, 2020, the Comptroller General of
the United States shall submit to Congress a report examining
how substance use disorder services are reimbursed.
SEC. 3315. SOBRIETY TREATMENT AND RECOVERY TEAMS (START).
Title V of the Public Health Service Act (42 U.S.C. 290dd
et seq.), as amended by section 3313, is further amended by
adding at the end the following:
``SEC. 551. SOBRIETY TREATMENT AND RECOVERY TEAMS.
``(a) In General.--The Secretary may make grants to States,
units of local government, or tribal governments to establish
or expand Sobriety Treatment And Recovery Team (referred to
in this section as `START') or other similar programs to
determine the effectiveness of pairing social workers or
mentors with families that are struggling with a substance
use disorder and child abuse or neglect in order to help
provide peer support, intensive treatment, and child welfare
services to such families.
``(b) Allowable Uses.--A grant awarded under this section
may be used for one or more of the following activities:
``(1) Training eligible staff, including social workers,
social services coordinators, child welfare specialists,
substance use disorder treatment professionals, and mentors.
``(2) Expanding access to substance use disorder treatment
services and drug testing.
``(3) Enhancing data sharing with law enforcement agencies,
child welfare agencies, substance use disorder treatment
providers, judges, and court personnel.
``(4) Program evaluation and technical assistance.
``(c) Program Requirements.--A State, unit of local
government, or tribal government receiving a grant under this
section shall--
``(1) serve only families for which--
``(A) there is an open record with the child welfare
agency; and
``(B) substance use disorder was a reason for the record or
finding described in paragraph (1); and
``(2) coordinate any grants awarded under this section with
any grant awarded under section 437(f) of the Social Security
Act focused on improving outcomes for children affected by
substance abuse.
``(d) Technical Assistance.--The Secretary may reserve not
more than 5 percent of funds provided under this section to
provide technical assistance on the establishment or
expansion of programs funded under this section from the
National Center on Substance Abuse and Child Welfare.
``(e) Authorization of Appropriations.--For each of fiscal
years 2018 through 2022, the Secretary is authorized to award
not more than $10,000,000 of amounts otherwise appropriated
to the Secretary for comprehensive opioid abuse reduction
activities for purposes of carrying out this section.''.
SEC. 3316. PROVIDER EDUCATION.
Not later than 60 days after the date of enactment of this
Act, the Attorney General, in consultation with the Secretary
of Health and Human Services, shall complete the plan related
to medical registration coordination required by Senate
Report 114-239, which accompanied the Veterans Care Financial
Protection Act of 2017 (Public Law 115-131; 132 Stat. 334).
SEC. 3317. DEMAND REDUCTION.
Section 702(1) of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1701(1)) is
amended--
(1) by redesignating subparagraphs (F) through (J) as
subparagraphs (G) through (K), respectively; and
(2) by inserting after subparagraph (E) the following:
``(F) support for long-term recovery from substance use
disorders;''.
SEC. 3318. ANTI-DRUG MEDIA CAMPAIGN.
Section 709 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1708) is amended--
(1) in the section heading, by striking ``youth'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``youth'';
(B) in paragraph (1), by striking ``young'';
(C) in paragraph (2), by striking ``of adults of the impact
of drug abuse on young people'' and inserting ``among the
population about the impact of drug abuse''; and
(D) in paragraph (3), by striking ``parents and other
interested adults to discuss with young people'' and
inserting ``interested persons to discuss''; and
(3) in subsection (b)(2)(C)(ii), by striking ``among
youth''.
SEC. 3319. TECHNICAL CORRECTIONS TO THE OFFICE OF NATIONAL
DRUG CONTROL POLICY REAUTHORIZATION ACT OF
1998.
The Office of National Drug Control Policy Reauthorization
Act of 1998 (21 U.S.C. 1701 et seq.) is amended--
(1) in section 703(b)(3)(E) (21 U.S.C. 1702(b)(3)(E))--
(A) in clause (i), by adding ``and'' at the end;
(B) in clause (ii), by striking ``; and'' and inserting a
period; and
(C) by striking clause (iii);
(2) in section 704 (21 U.S.C. 1703)--
(A) in subsection (c)(3)(C)--
(i) in clause (v), by adding ``and'' at the end;
(ii) in clause (vi), by striking ``; and'' and inserting a
period; and
(iii) by striking clause (vii); and
(B) in subsection (f)--
(i) by striking the first paragraph (5); and
(ii) by striking the second paragraph (4);
(3) in section 706(a)(2)(A) (21 U.S.C. 1705(a)(2)(A))--
(A) by striking clause (ix); and
(B) by redesignating clauses (x) through (xiv) as clauses
(ix) through (xiii), respectively; and
(4) by striking section 708 (21 U.S.C. 1707).
Subtitle D--Synthetic Abuse and Labeling of Toxic Substances
SEC. 3401. SHORT TITLE.
This subtitle may be cited as the ``Synthetic Abuse and
Labeling of Toxic Substances Act of 2017'' or the ``SALTS
Act''.
SEC. 3402. CONTROLLED SUBSTANCE ANALOGUES.
Section 203 of the Controlled Substances Act (21 U.S.C.
813) is amended--
(1) by striking ``A controlled'' and inserting ``(a) In
General.--A controlled''; and
(2) by adding at the end the following:
``(b) Determination.--In determining whether a controlled
substance analogue was intended for human consumption under
subsection (a), evidence related to the following factors may
be considered, along with all other relevant evidence:
``(1) The marketing, advertising, and labeling of the
substance.
``(2) The known efficacy or usefulness of the substance for
the marketed, advertised, or labeled purpose.
``(3) The difference between the price at which the
substance is sold and the price at which the substance it is
purported to be or advertised as is normally sold.
``(4) The diversion of the substance from legitimate
channels and the clandestine importation, manufacture, or
distribution of the substance.
``(5) Whether the defendant knew or should have known the
substance was intended to be consumed by injection,
inhalation, ingestion, or any other immediate means.
``(c) Limitation.--For purposes of this section, the
existence of evidence that a substance was not marketed,
advertised, or labeled for human consumption shall not
preclude the Government from establishing, based on all the
evidence, that the substance was intended for human
consumption.''.
Subtitle E--Opioid Quota Reform
SEC. 3501. SHORT TITLE.
This subtitle may be cited as the ``Opioid Quota Reform
Act''.
SEC. 3502. STRENGTHENING CONSIDERATIONS FOR DEA OPIOID
QUOTAS.
(a) In General.--Section 306 of the Controlled Substances
Act (21 U.S.C. 826) is amended--
(1) in subsection (a)--
(A) by inserting ``(1)'' after ``(a)'';
(B) in the second sentence, by striking ``Production'' and
inserting ``Except as provided in paragraph (2),
production''; and
(C) by adding at the end the following:
``(2) The Attorney General may, if the Attorney General
determines it will assist in avoiding the overproduction,
shortages, or diversion of a controlled substance, establish
an aggregate or individual production quota under this
subsection, or a procurement quota established by the
Attorney General by regulation, in terms of pharmaceutical
dosage forms prepared from or containing the controlled
substance.'';
(2) in subsection (b), in the first sentence, by striking
``production'' and inserting ``manufacturing'';
(3) in subsection (c), by striking ``October'' and
inserting ``December''; and
(4) by adding at the end the following:
``(i)(1)(A) In establishing any quota under this section,
or any procurement quota established by the Attorney General
by regulation, for fentanyl, oxycodone, hydrocodone,
oxymorphone, or hydromorphone (in this subsection referred to
as a `covered controlled substance'), the Attorney General
shall estimate the amount of diversion of the covered
controlled substance that occurs in the United States.
``(B) In estimating diversion under this paragraph, the
Attorney General--
[[Page S6097]]
``(i) shall consider information the Attorney General, in
consultation with the Secretary of Health and Human Services,
determines reliable on rates of overdose deaths and abuse and
overall public health impact related to the covered
controlled substance in the United States; and
``(ii) may take into consideration whatever other sources
of information the Attorney General determines reliable.
``(C) After estimating the amount of diversion of a covered
controlled substance, the Attorney General shall make
appropriate quota reductions, as determined by the Attorney
General, from the quota the Attorney General would have
otherwise established had such diversion not been considered.
``(2)(A) For any year for which the approved aggregate
production quota for a covered controlled substance is higher
than the approved aggregate production quota for the covered
controlled substance for the previous year, the Attorney
General shall include in the final order an explanation of
why the public health benefits of increasing the quota
clearly outweigh the consequences of having an increased
volume of the covered controlled substance available for
sale, and potential diversion, in the United States.
``(B) Not later than 1 year after the date of enactment of
this subsection, and every year thereafter, the Attorney
General shall submit to the Caucus on International Narcotics
Control, the Committee on the Judiciary, the Committee on
Health, Education, Labor, and Pensions, and the Committee on
Appropriations of the Senate and the Committee on the
Judiciary, the Committee on Energy and Commerce, and the
Committee on Appropriations of the House of Representatives
the following information with regard to each covered
controlled substance:
``(i) An anonymized count of the total number of
manufacturers issued individual manufacturing quotas that
year for the covered controlled substance.
``(ii) An anonymized count of how many such manufacturers
were issued an approved manufacturing quota that was higher
than the quota issued to that manufacturer for the covered
controlled substance in the previous year.
``(3) Not later than 1 year after the date of enactment of
this subsection, the Attorney General shall submit to
Congress a report on how the Attorney General, when fixing
and adjusting production and manufacturing quotas under this
section for covered controlled substances, will--
``(A) take into consideration changes in the accepted
medical use of the covered controlled substances; and
``(B) work with the Secretary of Health and Human Services
on methods to appropriately and anonymously estimate the type
and amount of covered controlled substances that are
submitted for collection from approved drug collection
receptacles, mail-back programs, and take-back events.''.
(b) Conforming Change.--The Law Revision Counsel is
directed to amend the heading for subsection (b) of section
826 of title 21, United States Code, by striking
``Production'' and inserting ``Manufacturing''.
Subtitle F--Preventing Drug Diversion
SEC. 3601. SHORT TITLE.
This subtitle may be cited as the ``Preventing Drug
Diversion Act of 2018''.
SEC. 3602. IMPROVEMENTS TO PREVENT DRUG DIVERSION.
(a) Definition.--Section 102 of the Controlled Substances
Act (21 U.S.C. 802) is amended by adding at the end the
following:
``(57) The term `suspicious order' includes--
``(A) an order of a controlled substance of unusual size;
``(B) an order of a controlled substance deviating
substantially from a normal pattern;
``(C) orders of controlled substances of unusual frequency;
and
``(D) an order having any characteristic that would
indicate to a reasonable registrant that it is suspicious or
not legitimate.''.
(b) Suspicious Orders.--Part C of the Controlled Substances
Act (21 U.S.C. 821 et seq.) is amended by adding at the end
the following:
``SEC. 312. SUSPICIOUS ORDERS.
``(a) Reporting.--Each registrant shall--
``(1) design and operate a system to identify suspicious
orders for the registrant;
``(2) ensure that the system designed and operated under
paragraph (1) by the registrant complies with applicable
Federal and State privacy laws; and
``(3) upon discovering a suspicious order or series of
orders, notify the Administrator of the Drug Enforcement
Administration and the Special Agent in Charge of the
Division Office of the Drug Enforcement Administration for
the area in which the registrant is located or conducts
business.
``(b) Suspicious Order Database.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Attorney General shall
establish a centralized database for collecting reports of
suspicious orders.
``(2) Satisfaction of reporting requirements.--If a
registrant reports a suspicious order to the centralized
database established under paragraph (1), the registrant
shall be considered to have complied with the requirement
under subsection (a)(3) to notify the Administrator of the
Drug Enforcement Administration and the Special Agent in
Charge of the Division Office of the Drug Enforcement
Administration for the area in which the registrant is
located or conducts business.
``(c) Sharing Information With the States.--
``(1) In general.--The Attorney General shall prepare and
make available information regarding suspicious orders in a
State, including information in the database established
under subsection (b)(1), to the point of contact for purposes
of administrative, civil, and criminal oversight relating to
the diversion of controlled substances for the State, as
designated by the Governor or chief executive officer of the
State.
``(2) Timing.--The Attorney General shall provide
information in accordance with paragraph (1) within a
reasonable period of time after obtaining the information.
``(3) Coordination.--In establishing the process for the
provision of information under this subsection, the Attorney
General shall coordinate with States to ensure that the
Attorney General has access to information, as permitted
under State law, possessed by the States relating to
prescriptions for controlled substances that will assist in
enforcing Federal law.''.
(c) Reports to Congress.--
(1) Definition.--In this subsection, the term ``suspicious
order'' has the meaning given that term in section 102 of the
Controlled Substances Act, as amended by this subtitle.
(2) One time report.--Not later than 1 year after the date
of enactment of this Act, the Attorney General shall submit
to Congress a report on the reporting of suspicious orders,
which shall include--
(A) a description of the centralized database established
under section 312 of the Controlled Substances Act, as added
by this section, to collect reports of suspicious orders;
(B) a description of the system and reports established
under section 312 of the Controlled Substances Act, as added
by this section, to share information with States;
(C) information regarding how the Attorney General used
reports of suspicious orders before the date of enactment of
this Act and after the date of enactment of this Act,
including how the Attorney General received the reports and
what actions were taken in response to the reports; and
(D) descriptions of the data analyses conducted on reports
of suspicious orders to identify, analyze, and stop
suspicious activity.
(3) Additional reports.--Not later than 1 year after the
date of enactment of this Act, and annually thereafter until
the date that is 5 years after the date of enactment of this
Act, the Attorney General shall submit to Congress a report
providing, for the previous year--
(A) the number of reports of suspicious orders;
(B) a summary of actions taken in response to reports, in
the aggregate, of suspicious orders; and
(C) a description of the information shared with States
based on reports of suspicious orders.
(4) One time gao report.--Not later than 1 year after the
date of enactment of this Act, the Comptroller General of the
United States, in consultation with the Administrator of the
Drug Enforcement Administration, shall submit to Congress a
report on the reporting of suspicious orders, which shall
include an evaluation of the utility of real-time reporting
of potential suspicious orders of opioids on a national level
using computerized algorithms, including the extent to which
such algorithms--
(A) would help ensure that potentially suspicious orders
are more accurately captured, identified, and reported in
real-time to suppliers before orders are filled;
(B) may produce false positives of suspicious order reports
that could result in market disruptions for legitimate orders
of opioids; and
(C) would reduce the overall length of an investigation
that prevents the diversion of suspicious orders of opioids.
Subtitle G--Sense of Congress
SEC. 3701. SENSE OF CONGRESS.
It is the sense of Congress that:
(1) Americans with substance use disorders often seek
treatment through recovery homes and clinical treatment
facilities that offer detoxification, risk reduction,
outpatient treatment, residential treatment, or
rehabilitation for substance use. Most of those facilities
provide a critical function in addressing substance misuse
and abuse, particularly as the incidence and prevalence of
substance use disorders, and drug overdose numbers continue
to rise.
(2) Despite the necessity of such treatment facilities and
the important services most provide, there are some bad
actors in the industry who, through telemarketing and other
schemes, actively recruit patients with private insurance so
that programs can bill the insurers without providing the
necessary treatment services. Often these ``patient brokers''
are paid for each patient successfully recruited. Payments
are also made as a percentage of billings, which incentivizes
brokers to recommend patients even at low risk levels to the
most aggressive and most expensive treatment programs.
(3) Unless the patient is enrolled in a Federal health care
program, a gap in Federal law exists with respect to patient
brokers who are improperly recruiting unsuspecting patients
to defraud insurance companies.
(4) It is important that Congress provide a mechanism to
penalize these bad actors, while minding legitimate entities
who continue to help patients find reputable treatment
programs.
[[Page S6098]]
TITLE IV--COMMERCE
Subtitle A--Fighting Opioid Abuse in Transportation
SEC. 4101. SHORT TITLE.
This subtitle may be cited as the ``Fighting Opioid Abuse
in Transportation Act''.
SEC. 4102. RAIL MECHANICAL EMPLOYEE CONTROLLED SUBSTANCES AND
ALCOHOL TESTING.
(a) Rail Mechanical Employees.--Not later than 2 years
after the date of enactment of this Act, the Secretary of
Transportation shall publish a final rule in the Federal
Register revising the regulations promulgated under section
20140 of title 49, United States Code, to designate a rail
mechanical employee as a railroad employee responsible for
safety-sensitive functions for purposes of that section.
(b) Definition of Rail Mechanical Employee.--The Secretary
shall define the term ``rail mechanical employee'' by
regulation under subsection (a).
(c) Savings Clause.--Nothing in this section may be
construed as limiting or otherwise affecting the discretion
of the Secretary of Transportation to set different
requirements by railroad size or other factors, consistent
with applicable law.
SEC. 4103. RAIL YARDMASTER CONTROLLED SUBSTANCES AND ALCOHOL
TESTING.
(a) Yardmasters.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Transportation shall
publish a final rule in the Federal Register revising the
regulations promulgated under section 20140 of title 49,
United States Code, to designate a yardmaster as a railroad
employee responsible for safety-sensitive functions for
purposes of that section.
(b) Definition of Yardmaster.--The Secretary shall define
the term ``yardmaster'' by regulation under subsection (a).
(c) Savings Clause.--Nothing in this section may be
construed as limiting or otherwise affecting the discretion
of the Secretary of Transportation to set different
requirements by railroad size or other factors, consistent
with applicable law.
SEC. 4104. DEPARTMENT OF TRANSPORTATION PUBLIC DRUG AND
ALCOHOL TESTING DATABASE.
(a) In General.--Subject to subsection (c), the Secretary
of Transportation shall--
(1) not later than March 31, 2019, establish and make
publicly available on its website a database of the drug and
alcohol testing data reported by employers for each mode of
transportation; and
(2) update the database annually.
(b) Contents.--The database under subsection (a) shall
include, for each mode of transportation--
(1) the total number of drug and alcohol tests by type of
substance tested;
(2) the drug and alcohol test results by type of substance
tested;
(3) the reason for the drug or alcohol test, such as pre-
employment, random, post-accident, reasonable suspicion or
cause, return-to-duty, or follow-up, by type of substance
tested; and
(4) the number of individuals who refused testing.
(c) Commercially Sensitive Data.--The Department of
Transportation shall not release any commercially sensitive
data furnished by an employer under this section unless the
data is aggregated or otherwise in a form that does not
identify the employer providing the data.
(d) Savings Clause.--Nothing in this section may be
construed as limiting or otherwise affecting the requirements
of the Secretary of Transportation to adhere to requirements
applicable to confidential business information and sensitive
security information, consistent with applicable law.
SEC. 4105. GAO REPORT ON DEPARTMENT OF TRANSPORTATION'S
COLLECTION AND USE OF DRUG AND ALCOHOL TESTING
DATA.
(a) In General.--Not later than 2 years after the date the
Department of Transportation public drug and alcohol testing
database is established under section 4104, the Comptroller
General of the United States shall--
(1) review the Department of Transportation Drug and
Alcohol Testing Management Information System; and
(2) submit to the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on
Transportation and Infrastructure of the House of
Representatives a report on the review, including
recommendations under subsection (c).
(b) Contents.--The report under subsection (a) shall
include--
(1) a description of the process the Department of
Transportation uses to collect and record drug and alcohol
testing data submitted by employers for each mode of
transportation;
(2) an assessment of whether and, if so, how the Department
of Transportation uses the data described in paragraph (1) in
carrying out its responsibilities; and
(3) an assessment of the Department of Transportation
public drug and alcohol testing database under section 4104.
(c) Recommendations.--The report under subsection (a) may
include recommendations regarding--
(1) how the Department of Transportation can best use the
data described in subsection (b)(1);
(2) any improvements that could be made to the process
described in subsection (b)(1);
(3) whether and, if so, how the Department of
Transportation public drug and alcohol testing database under
section 4104 could be made more effective; and
(4) such other recommendations as the Comptroller General
considers appropriate.
SEC. 4106. TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING
PROGRAM; ADDITION OF FENTANYL.
(a) Mandatory Guidelines for Federal Workplace Drug Testing
Programs.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall determine whether a revision of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs to
expand the opioid category on the list of authorized drug
testing to include fentanyl is justified, based on the
reliability and cost-effectiveness of available testing.
(2) Revision of guidelines.--If the expansion of the opioid
category is determined to be justified under paragraph (1),
the Secretary of Health and Human Services shall--
(A) notify the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on
Transportation and Infrastructure of the House of
Representatives of the determination; and
(B) publish in the Federal Register, not later than 18
months after the date of the determination under that
paragraph, a final notice of the revision of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs to
expand the opioid category on the list of authorized drug
testing to include fentanyl.
(3) Report.--If the expansion of the opioid category is
determined not to be justified under paragraph (1), the
Secretary of Health and Human Services shall submit to the
Committee on Commerce, Science, and Transportation of the
Senate and the Committee on Transportation and Infrastructure
of the House of Representatives a report explaining, in
detail, the reasons the expansion of the opioid category on
the list of authorized drugs to include fentanyl is not
justified.
(b) Department of Transportation Drug-testing Panel.--If
the expansion of the opioid category is determined to be
justified under subsection (a)(1), the Secretary of
Transportation shall publish in the Federal Register, not
later than 18 months after the date the final notice is
published under subsection (a)(2), a final rule revising part
40 of title 49, Code of Federal Regulations, to include
fentanyl in the Department of Transportation's drug-testing
panel, consistent with the Mandatory Guidelines for Federal
Workplace Drug Testing Programs as revised by the Secretary
of Health and Human Services under subsection (a).
(c) Savings Provision.--Nothing in this section may be
construed as--
(1) delaying the publication of the notices described in
sections 4107 and 4108 until the Secretary of Health and
Human Services makes a determination or publishes a notice
under this section; or
(2) limiting or otherwise affecting any authority of the
Secretary of Health and Human Services or the Secretary of
Transportation to expand the list of authorized drug testing
to include an additional substance.
SEC. 4107. STATUS REPORTS ON HAIR TESTING GUIDELINES.
(a) In General.--Not later than 30 days after the date of
enactment of this Act, and every 180 days thereafter until
the date that the Secretary of Health and Human Services
publishes in the Federal Register a final notice of
scientific and technical guidelines for hair testing in
accordance with section 5402(b) of the Fixing America's
Surface Transportation Act (Public Law 114-94; 129 Stat.
1312), the Secretary of Health and Human Services shall
submit to the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on
Transportation and Infrastructure of the House of
Representatives a report on--
(1) the status of the hair testing guidelines;
(2) an explanation for why the hair testing guidelines have
not been issued;
(3) a schedule, including benchmarks, for the completion of
the hair testing guidelines; and
(4) an estimated date of completion of the hair testing
guidelines.
(b) Requirement.--To the extent practicable and consistent
with the objective of the hair testing described in
subsection (a) to detect illegal or unauthorized use of
substances by the individual being tested, the final notice
of scientific and technical guidelines under that subsection,
as determined by the Secretary of Health and Human Services,
shall eliminate the risk of positive test results of the
individual being tested caused solely by the drug use of
others and not caused by the drug use of the individual being
tested.
SEC. 4108. MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG
TESTING PROGRAMS USING ORAL FLUID.
(a) Deadline.--Not later than December 31, 2018, the
Secretary of Health and Human Services shall publish in the
Federal Register a final notice of the Mandatory Guidelines
for Federal Workplace Drug Testing Programs using Oral Fluid,
based on the notice of proposed mandatory guidelines
published in the Federal Register on May 15, 2015 (80 Fed.
Reg. 28054).
(b) Requirement.--To the extent practicable and consistent
with the objective of the testing described in subsection (a)
to detect illegal or unauthorized use of substances by the
individual being tested, the final notice of scientific and
technical guidelines under that subsection, as determined by
the
[[Page S6099]]
Secretary of Health and Human Services, shall eliminate the
risk of positive test results of the individual being tested
caused solely by the drug use of others and not caused by the
drug use of the individual being tested.
(c) Rule of Construction.--Nothing in this section may be
construed as requiring the Secretary of Health and Human
Services to reissue a notice of proposed mandatory guidelines
to carry out subsection (a).
SEC. 4109. ELECTRONIC RECORDKEEPING.
(a) Deadline.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall--
(1) ensure that each certified laboratory that requests
approval for the use of completely paperless electronic
Federal Drug Testing Custody and Control Forms from the
National Laboratory Certification Program's Electronic
Custody and Control Form systems receives approval for those
completely paperless electronic forms instead of forms that
include any combination of electronic traditional handwritten
signatures executed on paper forms; and
(2) establish a deadline for a certified laboratory to
request approval under paragraph (1).
(b) Savings Clause.--Nothing in this section may be
construed as limiting or otherwise affecting any authority of
the Secretary of Health and Human Services to grant approval
to a certified laboratory for use of completely paperless
electronic Federal Drug Testing Custody and Control Forms,
including to grant approval outside of the process under
subsection (a).
(c) Electronic Signatures.--Not later than 18 months after
the date of the deadline under subsection (a)(2), the
Secretary of Transportation shall issue a final rule revising
part 40 of title 49, Code of Federal Regulations, to
authorize, to the extent practicable, the use of electronic
signatures or digital signatures executed to electronic forms
instead of traditional handwritten signatures executed on
paper forms.
SEC. 4110. STATUS REPORTS ON COMMERCIAL DRIVER'S LICENSE DRUG
AND ALCOHOL CLEARINGHOUSE.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, and biannually thereafter until the
compliance date, the Administrator of the Federal Motor
Carrier Safety Administration shall submit to the Committee
on Commerce, Science, and Transportation of the Senate and
the Committee on Transportation and Infrastructure of the
House of Representatives a status report on implementation of
the final rule for the Commercial Driver's License Drug and
Alcohol Clearinghouse (81 Fed. Reg. 87686), including--
(1) an updated schedule, including benchmarks, for
implementing the final rule as soon as practicable, but not
later than the compliance date; and
(2) a description of each action the Federal Motor Carrier
Safety Administration is taking to implement the final rule
before the compliance date.
(b) Definition of Compliance Date.--In this section, the
term ``compliance date'' means the earlier of--
(1) January 6, 2020; or
(2) the date that the national clearinghouse required under
section 31306a of title 49, United States Code, is
operational.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
SEC. 4201. SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction
Recovery Fraud Prevention Act of 2018''.
SEC. 4202. DEFINITIONS.
In this subtitle:
(1) Opioid treatment product.--The term ``opioid treatment
product'' means a product, including any supplement or
medication, for use or marketed for use in the treatment,
cure, or prevention of an opioid use disorder.
(2) Opioid treatment program.--The term ``opioid treatment
program'' means a program that provides treatment for people
diagnosed with, having, or purporting to have an opioid use
disorder.
(3) Opioid use disorder.--The term ``opioid use disorder''
means a cluster of cognitive, behavioral, or physiological
symptoms in which the individual continues use of opioids
despite significant opioid-induced problems, such as adverse
health effects.
SEC. 4203. FALSE OR MISLEADING REPRESENTATIONS WITH RESPECT
TO OPIOID TREATMENT PROGRAMS AND PRODUCTS.
(a) Unlawful Activity.--It is unlawful to make any
deceptive representation with respect to the cost, price,
efficacy, performance, benefit, risk, or safety of any opioid
treatment program or opioid treatment product.
(b) Enforcement by the Federal Trade Commission.--
(1) Unfair or deceptive acts or practices.--A violation of
subsection (a) shall be treated as a violation of a rule
under section 18 of the Federal Trade Commission Act (15
U.S.C. 57a) regarding unfair or deceptive acts or practices.
(2) Powers of the federal trade commission.--
(A) In general.--The Federal Trade Commission shall enforce
this section in the same manner, by the same means, and with
the same jurisdiction, powers, and duties as though all
applicable terms and provisions of the Federal Trade
Commission Act (15 U.S.C. 41 et seq.) were incorporated into
and made a part of this section.
(B) Privileges and immunities.--Any person who violates
subsection (a) shall be subject to the penalties and entitled
to the privileges and immunities provided in the Federal
Trade Commission Act as though all applicable terms and
provisions of the Federal Trade Commission Act (15 U.S.C. 41
et seq.) were incorporated and made part of this section.
(c) Enforcement by States.--
(1) In general.--Except as provided in paragraph (4), in
any case in which the attorney general of a State has reason
to believe that an interest of the residents of the State has
been or is threatened or adversely affected by any person who
violates subsection (a), the attorney general of the State,
as parens patriae, may bring a civil action on behalf of the
residents of the State in an appropriate district court of
the United States to obtain appropriate relief.
(2) Rights of federal trade commission.--
(A) Notice to federal trade commission.--
(i) In general.--Except as provided in clause (iii), the
attorney general of a State shall notify the Federal Trade
Commission in writing that the attorney general intends to
bring a civil action under paragraph (1) before initiating
the civil action.
(ii) Contents.--The notification required by clause (i)
with respect to a civil action shall include a copy of the
complaint to be filed to initiate the civil action.
(iii) Exception.--If it is not feasible for the attorney
general of a State to provide the notification required by
clause (i) before initiating a civil action under paragraph
(1), the attorney general shall notify the Federal Trade
Commission immediately upon instituting the civil action.
(B) Intervention by federal trade commission.--The Federal
Trade Commission may--
(i) intervene in any civil action brought by the attorney
general of a State under paragraph (1); and
(ii) upon intervening--
(I) be heard on all matters arising in the civil action;
and
(II) file petitions for appeal.
(3) Investigatory powers.--Nothing in this subsection shall
be construed to prevent the attorney general of a State from
exercising the powers conferred on the attorney general by
the laws of the State to conduct investigations, to
administer oaths or affirmations, or to compel the attendance
of witnesses or the production of documentary or other
evidence.
(4) Preemptive action by federal trade commission.--If the
Federal Trade Commission or the Attorney General on behalf of
the Commission institutes a civil action, or the Federal
Trade Commission institutes an administrative action, with
respect to a violation of subsection (a), the attorney
general of a State may not, during the pendency of that
action, bring a civil action under paragraph (1) against any
defendant or respondent named in the complaint of the
Commission for the violation with respect to which the
Commission instituted such action.
(5) Venue; service of process.--
(A) Venue.--Any action brought under paragraph (1) may be
brought in any district court of the United States that meets
applicable requirements relating to venue under section 1391
of title 28, United States Code.
(B) Service of process.--In an action brought under
paragraph (1), process may be served in any district in which
the defendant--
(i) is an inhabitant; or
(ii) may be found.
(6) Actions by other state officials.--In addition to civil
actions brought by attorneys general under paragraph (1), any
other consumer protection officer of a State who is
authorized by the State to do so may bring a civil action
under paragraph (1), subject to the same requirements and
limitations that apply under this subsection to civil actions
brought by attorneys general.
(d) Authority Preserved.--Nothing in this title shall be
construed to limit the authority of the Federal Trade
Commission or the Food and Drug Administration under any
other provision of law.
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