[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Engrossed Amendment Senate (EAS)]
<DOC>
In the Senate of the United States,
September 17, 2018.
Resolved, That the bill from the House of Representatives (H.R. 6)
entitled ``An Act to provide for opioid use disorder prevention,
recovery, and treatment, and for other purposes.'', do pass with the
following
AMENDMENT:
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.
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'';
(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 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 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 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
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 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
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--
(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.--
(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
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 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
(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
``(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.--
(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 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 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
(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
(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 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
(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.
``(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.
(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;
(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. 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
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 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 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 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 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 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:
(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 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--
``(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.
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 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.
Attest:
Secretary.
115th CONGRESS
2d Session
H.R. 6
_______________________________________________________________________
AMENDMENT