[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Enrolled Bill (ENR)]
H.R.6
One Hundred Fifteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, two thousand and eighteen
An Act
To provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act'' or the ``SUPPORT for Patients and
Communities Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 1001. At-risk youth Medicaid protection.
Sec. 1002. Health insurance for former foster youth.
Sec. 1003. Demonstration project to increase substance use provider
capacity under the Medicaid program.
Sec. 1004. Medicaid drug review and utilization.
Sec. 1005. Guidance to improve care for infants with neonatal abstinence
syndrome and their mothers; GAO study on gaps in Medicaid
coverage for pregnant and postpartum women with substance use
disorder.
Sec. 1006. Medicaid health homes for substance-use-disorder Medicaid
enrollees.
Sec. 1007. Caring recovery for infants and babies.
Sec. 1008. Peer support enhancement and evaluation review.
Sec. 1009. Medicaid substance use disorder treatment via telehealth.
Sec. 1010. Enhancing patient access to non-opioid treatment options.
Sec. 1011. Assessing barriers to opioid use disorder treatment.
Sec. 1012. Help for moms and babies.
Sec. 1013. Securing flexibility to treat substance use disorders.
Sec. 1014. MACPAC study and report on MAT utilization controls under
State Medicaid programs.
Sec. 1015. Opioid addiction treatment programs enhancement.
Sec. 1016. Better data sharing to combat the opioid crisis.
Sec. 1017. Report on innovative State initiatives and strategies to
provide housing-related services and supports to individuals
struggling with substance use disorders under Medicaid.
Sec. 1018. Technical assistance and support for innovative State
strategies to provide housing-related supports under Medicaid.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 2001. Expanding the use of telehealth services for the treatment of
opioid use disorder and other substance use disorders.
Sec. 2002. Comprehensive screenings for seniors.
Sec. 2003. Every prescription conveyed securely.
Sec. 2004. Requiring prescription drug plan sponsors under Medicare to
establish drug management programs for at-risk beneficiaries.
Sec. 2005. Medicare coverage of certain services furnished by opioid
treatment programs.
Sec. 2006. Encouraging appropriate prescribing under Medicare for
victims of opioid overdose.
Sec. 2007. Automatic escalation to external review under a Medicare part
D drug management program for at-risk beneficiaries.
Sec. 2008. Suspension of payments by Medicare prescription drug plans
and MA-PD plans pending investigations of credible allegations
of fraud by pharmacies.
TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS
Subtitle A--FDA Provisions
Chapter 1--In General
Sec. 3001. Clarifying FDA regulation of non-addictive pain products.
Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and
report.
Chapter 2--Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now
Sec. 3011. Short title.
Sec. 3012. Notification, nondistribution, and recall of controlled
substances.
Sec. 3013. Single source pattern of imported illegal drugs.
Sec. 3014. Strengthening FDA and CBP coordination and capacity.
Chapter 3--Stop Illicit Drug Importation
Sec. 3021. Short title.
Sec. 3022. Restricting entrance of illicit drugs.
Chapter 4--Securing Opioids and Unused Narcotics With Deliberate
Disposal and Packaging
Sec. 3031. Short title.
Sec. 3032. Safety-enhancing packaging and disposal features.
Chapter 5--Postapproval Study Requirements
Sec. 3041. Clarifying FDA postmarket authorities.
Subtitle B--Controlled Substance Provisions
Chapter 1--More Flexibility With Respect to Medication-Assisted
Treatment for Opioid Use Disorders
Sec. 3201. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use disorders.
Sec. 3202. Medication-assisted treatment for recovery from substance use
disorder.
Sec. 3203. Grants to enhance access to substance use disorder treatment.
Sec. 3204. Delivery of a controlled substance by a pharmacy to be
administered by injection or implantation.
Chapter 2--Empowering Pharmacists in the Fight Against Opioid Abuse
Sec. 3211. Short title.
Sec. 3212. Programs and materials for training on certain circumstances
under which a pharmacist may decline to fill a prescription.
Chapter 3--Safe Disposal of Unused Medication
Sec. 3221. Short title.
Sec. 3222. Disposal of controlled substances of a hospice patient by
employees of a qualified hospice program.
Sec. 3223. GAO study and report on hospice safe drug management.
Chapter 4--Special Registration for Telemedicine Clarification
Sec. 3231. Short title.
Sec. 3232. Regulations relating to a special registration for
telemedicine.
Chapter 5--Synthetic Abuse and Labeling of Toxic Substances
Sec. 3241. Controlled substance analogues.
Chapter 6--Access to Increased Drug Disposal
Sec. 3251. Short title.
Sec. 3252. Definitions.
Sec. 3253. Authority to make grants.
Sec. 3254. Application.
Sec. 3255. Use of grant funds.
Sec. 3256. Eligibility for grant.
Sec. 3257. Duration of grants.
Sec. 3258. Accountability and oversight.
Sec. 3259. Duration of program.
Sec. 3260. Authorization of appropriations.
Chapter 7--Using Data To Prevent Opioid Diversion
Sec. 3271. Short title.
Sec. 3272. Purpose.
Sec. 3273. Amendments.
Sec. 3274. Report.
Chapter 8--Opioid Quota Reform
Sec. 3281. Short title.
Sec. 3282. Strengthening considerations for DEA opioid quotas.
Chapter 9--Preventing Drug Diversion
Sec. 3291. Short title.
Sec. 3292. Improvements to prevent drug diversion.
TITLE IV--OFFSETS
Sec. 4001. Promoting value in Medicaid managed care.
Sec. 4002. Requiring reporting by group health plans of prescription
drug coverage information for purposes of identifying primary
payer situations under the Medicare program.
Sec. 4003. Additional religious exemption from health coverage
responsibility requirement.
Sec. 4004. Modernizing the reporting of biological and biosimilar
products.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
Sec. 5001. Mandatory reporting with respect to adult behavioral health
measures.
Subtitle B--Medicaid IMD Additional Info
Sec. 5011. Short title.
Sec. 5012. MACPAC exploratory study and report on institutions for
mental diseases requirements and practices under Medicaid.
Subtitle C--CHIP Mental Health and Substance Use Disorder Parity
Sec. 5021. Short title.
Sec. 5022. Ensuring access to mental health and substance use disorder
services for children and pregnant women under the Children's
Health Insurance Program.
Subtitle D--Medicaid Reentry
Sec. 5031. Short title.
Sec. 5032. Promoting State innovations to ease transitions integration
to the community for certain individuals.
Subtitle E--Medicaid Partnership
Sec. 5041. Short title.
Sec. 5042. Medicaid providers are required to note experiences in record
systems to help in-need patients.
Subtitle F--IMD CARE Act
Sec. 5051. Short title.
Sec. 5052. State option to provide Medicaid coverage for certain
individuals with substance use disorders who are patients in
certain institutions for mental diseases.
Subtitle G--Medicaid Improvement Fund
Sec. 5061. Medicaid Improvement Fund.
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health
Providers for Adoption and Use of Certified Electronic Health Record
Technology
Sec. 6001. Testing of incentive payments for behavioral health providers
for adoption and use of certified electronic health record
technology.
Subtitle B--Abuse Deterrent Access
Sec. 6011. Short title.
Sec. 6012. Study on abuse-deterrent opioid formulations access barriers
under Medicare.
Subtitle C--Medicare Opioid Safety Education
Sec. 6021. Medicare opioid safety education.
Subtitle D--Opioid Addiction Action Plan
Sec. 6031. Short title.
Sec. 6032. Action plan on recommendations for changes under Medicare and
Medicaid to prevent opioids addictions and enhance access to
medication-assisted treatment.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders in
Medicare
Sec. 6041. Short title.
Sec. 6042. Opioid use disorder treatment demonstration program.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes for
Users' Treatment
Sec. 6051. Short title.
Sec. 6052. Grants to provide technical assistance to outlier prescribers
of opioids.
Subtitle G--Preventing Addiction for Susceptible Seniors
Sec. 6061. Short title.
Sec. 6062. Electronic prior authorization for covered part D drugs.
Sec. 6063. Program integrity transparency measures under Medicare parts
C and D.
Sec. 6064. Expanding eligibility for medication therapy management
programs under part D.
Sec. 6065. Commit to opioid medical prescriber accountability and safety
for seniors.
Sec. 6066. No additional funds authorized.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
Sec. 6071. Short title.
Sec. 6072. Medicare Payment Advisory Commission report on opioid
payment, adverse incentives, and data under the Medicare
program.
Sec. 6073. No additional funds authorized.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
Sec. 6081. Short title.
Sec. 6082. Review and adjustment of payments under the Medicare
outpatient prospective payment system to avoid financial
incentives to use opioids instead of non-opioid alternative
treatments.
Sec. 6083. Expanding access under the Medicare program to addiction
treatment in Federally qualified health centers and rural
health clinics.
Sec. 6084. Studying the availability of supplemental benefits designed
to treat or prevent substance use disorders under Medicare
Advantage plans.
Sec. 6085. Clinical psychologist services models under the Center for
Medicare and Medicaid Innovation; GAO study and report.
Sec. 6086. Dr. Todd Graham pain management study.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
Sec. 6091. Short title.
Sec. 6092. Developing guidance on pain management and opioid use
disorder prevention for hospitals receiving payment under part
A of the Medicare program.
Sec. 6093. Requiring the review of quality measures relating to opioids
and opioid use disorder treatments furnished under the
medicare program and other federal health care programs.
Sec. 6094. Technical expert panel on reducing surgical setting opioid
use; Data collection on perioperative opioid use.
Sec. 6095. Requiring the posting and periodic update of opioid
prescribing guidance for Medicare beneficiaries.
Subtitle K--Providing Reliable Options for Patients and Educational
Resources
Sec. 6101. Short title.
Sec. 6102. Requiring Medicare Advantage plans and part D prescription
drug plans to include information on risks associated with
opioids and coverage of nonpharmacological therapies and
nonopioid medications or devices used to treat pain.
Sec. 6103. Requiring Medicare Advantage plans and prescription drug
plans to provide information on the safe disposal of
prescription drugs.
Sec. 6104. Revising measures used under the Hospital Consumer Assessment
of Healthcare Providers and Systems survey relating to pain
management.
Subtitle L--Fighting the Opioid Epidemic With Sunshine
Sec. 6111. Fighting the opioid epidemic with sunshine.
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle A--Awareness and Training
Sec. 7001. Report on effects on public health of synthetic drug use.
Sec. 7002. First responder training.
Subtitle B--Pilot Program for Public Health Laboratories To Detect
Fentanyl and Other Synthetic Opioids
Sec. 7011. Pilot program for public health laboratories to detect
fentanyl and other synthetic opioids.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
Sec. 7021. Establishment of substance use disorder information
dashboard.
Sec. 7022. Interdepartmental Substance Use Disorders Coordinating
Committee.
Sec. 7023. National milestones to measure success in curtailing the
opioid crisis.
Sec. 7024. Study on prescribing limits.
Subtitle D--Ensuring Access to Quality Sober Living
Sec. 7031. National recovery housing best practices.
Subtitle E--Advancing Cutting Edge Research
Sec. 7041. Unique research initiatives.
Sec. 7042. Pain research.
Subtitle F--Jessie's Law
Sec. 7051. Inclusion of opioid addiction history in patient records.
Sec. 7052. Communication with families during emergencies.
Sec. 7053. Development and dissemination of model training programs for
substance use disorder patient records.
Subtitle G--Protecting Pregnant Women and Infants
Sec. 7061. Report on addressing maternal and infant health in the opioid
crisis.
Sec. 7062. Protecting moms and infants.
Sec. 7063. Early interventions for pregnant women and infants.
Sec. 7064. Prenatal and postnatal health.
Sec. 7065. Plans of safe care.
Subtitle H--Substance Use Disorder Treatment Workforce
Sec. 7071. Loan repayment program for substance use disorder treatment
workforce.
Sec. 7072. Clarification regarding service in schools and other
community-based settings.
Sec. 7073. Programs for health care workforce.
Subtitle I--Preventing Overdoses While in Emergency Rooms
Sec. 7081. Program to support coordination and continuation of care for
drug overdose patients.
Subtitle J--Alternatives to Opioids in the Emergency Department
Sec. 7091. Emergency department alternatives to opioids demonstration
program.
Subtitle K--Treatment, Education, and Community Help To Combat Addiction
Sec. 7101. Establishment of regional centers of excellence in substance
use disorder education.
Sec. 7102. Youth prevention and recovery.
Subtitle L--Information From National Mental Health and Substance Use
Policy Laboratory
Sec. 7111. Information from National Mental Health and Substance Use
Policy Laboratory.
Subtitle M--Comprehensive Opioid Recovery Centers
Sec. 7121. Comprehensive opioid recovery centers.
Subtitle N--Trauma-Informed Care
Sec. 7131. CDC surveillance and data collection for child, youth, and
adult trauma.
Sec. 7132. Task force to develop best practices for trauma-informed
identification, referral, and support.
Sec. 7133. National Child Traumatic Stress Initiative.
Sec. 7134. Grants to improve trauma support services and mental health
care for children and youth in educational settings.
Sec. 7135. Recognizing early childhood trauma related to substance
abuse.
Subtitle O--Eliminating Opioid Related Infectious Diseases
Sec. 7141. Reauthorization and expansion of program of surveillance and
education regarding infections associated with illicit drug
use and other risk factors.
Subtitle P--Peer Support Communities of Recovery
Sec. 7151. Building communities of recovery.
Sec. 7152. Peer support technical assistance center.
Subtitle Q--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
Sec. 7161. Preventing overdoses of controlled substances.
Sec. 7162. Prescription drug monitoring program.
Subtitle R--Review of Substance Use Disorder Treatment Providers
Receiving Federal Funding
Sec. 7171. Review of substance use disorder treatment providers
receiving Federal funding.
Subtitle S--Other Health Provisions
Sec. 7181. State response to the opioid abuse crisis.
Sec. 7182. Report on investigations regarding parity in mental health
and substance use disorder benefits.
Sec. 7183. CAREER Act.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
Sec. 8001. Short title.
Sec. 8002. Customs fees.
Sec. 8003. Mandatory advance electronic information for postal
shipments.
Sec. 8004. International postal agreements.
Sec. 8005. Cost recoupment.
Sec. 8006. Development of technology to detect illicit narcotics.
Sec. 8007. Civil penalties for postal shipments.
Sec. 8008. Report on violations of arrival, reporting, entry, and
clearance requirements and falsity or lack of manifest.
Sec. 8009. Effective date; regulations.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
Sec. 8021. Short title.
Sec. 8022. Definitions.
Sec. 8023. Unfair or deceptive acts or practices with respect to
substance use disorder treatment service and products.
Subtitle C--Addressing Economic and Workforce Impacts of the Opioid
Crisis
Sec. 8041. Addressing economic and workforce impacts of the opioid
crisis.
Subtitle D--Peer Support Counseling Program for Women Veterans
Sec. 8051. Peer support counseling program for women veterans.
Subtitle E--Treating Barriers to Prosperity
Sec. 8061. Short title.
Sec. 8062. Drug abuse mitigation initiative.
Subtitle F--Pilot Program to Help Individuals in Recovery From a
Substance Use Disorder Become Stably Housed
Sec. 8071. Pilot program to help individuals in recovery from a
substance use disorder become stably housed.
Subtitle G--Human Services
Sec. 8081. Supporting family-focused residential treatment.
Sec. 8082. Improving recovery and reunifying families.
Sec. 8083. Building capacity for family-focused residential treatment.
Subtitle H--Reauthorizing and Extending Grants for Recovery From Opioid
Use Programs
Sec. 8091. Short title.
Sec. 8092. Reauthorization of the comprehensive opioid abuse grant
program.
Subtitle I--Fighting Opioid Abuse in Transportation
Sec. 8101. Short title.
Sec. 8102. Alcohol and controlled substance testing of mechanical
employees.
Sec. 8103. Department of Transportation public drug and alcohol testing
database.
Sec. 8104. GAO report on Department of Transportation's collection and
use of drug and alcohol testing data.
Sec. 8105. Transportation Workplace Drug and Alcohol Testing Program;
addition of fentanyl and other substances.
Sec. 8106. Status reports on hair testing guidelines.
Sec. 8107. Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid.
Sec. 8108. Electronic recordkeeping.
Sec. 8109. Status reports on Commercial Driver's License Drug and
Alcohol Clearinghouse.
Subtitle J--Eliminating Kickbacks in Recovery
Sec. 8121. Short title.
Sec. 8122. Criminal penalties.
Subtitle K--Substance Abuse Prevention
Sec. 8201. Short title.
Sec. 8202. Reauthorization of the Office of National Drug Control
Policy.
Sec. 8203. Reauthorization of the Drug-Free Communities Program.
Sec. 8204. Reauthorization of the National Community Anti-Drug Coalition
Institute.
Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area
Program.
Sec. 8206. Reauthorization of drug court program.
Sec. 8207. Drug court training and technical assistance.
Sec. 8208. Drug overdose response strategy.
Sec. 8209. Protecting law enforcement officers from accidental exposure.
Sec. 8210. COPS Anti-Meth Program.
Sec. 8211. COPS anti-heroin task force program.
Sec. 8212. Comprehensive Addiction and Recovery Act education and
awareness.
Sec. 8213. Reimbursement of substance use disorder treatment
professionals.
Sec. 8214. Sobriety Treatment and Recovery Teams (START).
Sec. 8215. Provider education.
Sec. 8216. Definitions.
Sec. 8217. Amendments to administration of the Office.
Sec. 8218. Emerging threats committee, plan, and media campaign.
Sec. 8219. Drug interdiction.
Sec. 8220. GAO Audit.
Sec. 8221. National Drug Control Strategy.
Sec. 8222. Technical and conforming amendments to the Office of National
Drug Control Policy Reauthorization Act of 1998.
Subtitle L--Budgetary Effects
Sec. 8231. Budgetary effect.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 1001. AT-RISK YOUTH MEDICAID PROTECTION.
(a) In General.--Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended--
(1) in subsection (a)--
(A) by striking ``and'' at the end of paragraph (82);
(B) by striking the period at the end of paragraph (83) and
inserting ``; and''; and
(C) by inserting after paragraph (83) the following new
paragraph:
``(84) provide that--
``(A) the State shall not terminate eligibility for medical
assistance under the State plan for an individual who is an
eligible juvenile (as defined in subsection (nn)(2)) because
the juvenile is an inmate of a public institution (as defined
in subsection (nn)(3)), but may suspend coverage during the
period the juvenile is such an inmate;
``(B) in the case of an individual who is an eligible
juvenile described in paragraph (2)(A) of subsection (nn), the
State shall, prior to the individual's release from such a
public institution, conduct a redetermination of eligibility
for such individual with respect to such medical assistance
(without requiring a new application from the individual) and,
if the State determines pursuant to such redetermination that
the individual continues to meet the eligibility requirements
for such medical assistance, the State shall restore coverage
for such medical assistance to such an individual upon the
individual's release from such public institution; and
``(C) in the case of an individual who is an eligible
juvenile described in paragraph (2)(B) of subsection (nn), the
State shall process any application for medical assistance
submitted by, or on behalf of, such individual such that the
State makes a determination of eligibility for such individual
with respect to such medical assistance upon release of such
individual from such public institution.''; and
(2) by adding at the end the following new subsection:
``(nn) Juvenile; Eligible Juvenile; Public Institution.--For
purposes of subsection (a)(84) and this subsection:
``(1) Juvenile.--The term `juvenile' means an individual who
is--
``(A) under 21 years of age; or
``(B) described in subsection (a)(10)(A)(i)(IX).
``(2) Eligible juvenile.--The term `eligible juvenile' means a
juvenile who is an inmate of a public institution and who--
``(A) was determined eligible for medical assistance under
the State plan immediately before becoming an inmate of such a
public institution; or
``(B) is determined eligible for such medical assistance
while an inmate of a public institution.
``(3) Inmate of a public institution.--The term `inmate of a
public institution' has the meaning given such term for purposes of
applying the subdivision (A) following paragraph (30) of section
1905(a), taking into account the exception in such subdivision for
a patient of a medical institution.''.
(b) No Change in Exclusion From Medical Assistance for Inmates of
Public Institutions.--Nothing in this section shall be construed as
changing the exclusion from medical assistance under the subdivision
(A) following paragraph (30) of section 1905(a) of the Social Security
Act (42 U.S.C. 1396d(a)), as redesignated by section 1006(b)(2)(B) of
this Act, including any applicable restrictions on a State submitting
claims for Federal financial participation under title XIX of such Act
for such assistance.
(c) No Change in Continuity of Eligibility Before Adjudication or
Sentencing.--Nothing in this section shall be construed to mandate,
encourage, or suggest that a State suspend or terminate coverage for
individuals before they have been adjudicated or sentenced.
(d) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by subsection (a) shall apply to eligibility of
juveniles who become inmates of public institutions on or after the
date that is 1 year after the date of the enactment of this Act.
(2) Rule for changes requiring state legislation.--In the case
of a State plan for medical assistance 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 amendments 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. 1002. HEALTH INSURANCE FOR FORMER FOSTER YOUTH.
(a) Coverage Continuity for Former Foster Care Children up to Age
26.--
(1) In general.--Section 1902(a)(10)(A)(i)(IX) of the Social
Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is amended--
(A) in item (bb), by striking ``are not described in or
enrolled under'' and inserting ``are not described in and are
not enrolled under'';
(B) in item (cc), by striking ``responsibility of the
State'' and inserting ``responsibility of a State''; and
(C) in item (dd), by striking ``the State plan under this
title or under a waiver of the'' and inserting ``a State plan
under this title or under a waiver of such a''.
(2) Effective date.--The amendments made by this subsection
shall take effect with respect to foster youth who attain 18 years
of age on or after January 1, 2023.
(b) Guidance.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidance to States, with respect to the State Medicaid programs
of such States--
(1) on best practices for--
(A) removing barriers and ensuring streamlined, timely
access to Medicaid coverage for former foster youth up to age
26; and
(B) conducting outreach and raising awareness among such
youth regarding Medicaid coverage options for such youth; and
(2) which shall include examples of States that have
successfully extended Medicaid coverage to former foster youth up
to age 26.
SEC. 1003. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE PROVIDER
CAPACITY UNDER THE MEDICAID PROGRAM.
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is
amended by adding at the end the following new subsection:
``(aa) Demonstration Project To Increase Substance Use Provider
Capacity.--
``(1) In general.--Not later than the date that is 180 days
after the date of the enactment of this subsection, the Secretary
shall, in consultation, as appropriate, with the Director of the
Agency for Healthcare Research and Quality and the Assistant
Secretary for Mental Health and Substance Use, conduct a 54-month
demonstration project for the purpose described in paragraph (2)
under which the Secretary shall--
``(A) for the first 18-month period of such project, award
planning grants described in paragraph (3); and
``(B) for the remaining 36-month period of such project,
provide to each State selected under paragraph (4) payments in
accordance with paragraph (5).
``(2) Purpose.--The purpose described in this paragraph is for
each State selected under paragraph (4) to increase the treatment
capacity of providers participating under the State plan (or a
waiver of such plan) to provide substance use disorder treatment or
recovery services under such plan (or waiver) through the following
activities:
``(A) For the purpose described in paragraph (3)(C)(i),
activities that support an ongoing assessment of the behavioral
health treatment needs of the State, taking into account the
matters described in subclauses (I) through (IV) of such
paragraph.
``(B) Activities that, taking into account the results of
the assessment described in subparagraph (A), support the
recruitment, training, and provision of technical assistance
for providers participating under the State plan (or a waiver
of such plan) that offer substance use disorder treatment or
recovery services.
``(C) Improved reimbursement for and expansion of, through
the provision of education, training, and technical assistance,
the number or treatment capacity of providers participating
under the State plan (or waiver) that--
``(i) are authorized to dispense drugs approved by the
Food and Drug Administration for individuals with a
substance use disorder who need withdrawal management or
maintenance treatment for such disorder;
``(ii) have in effect a registration or waiver under
section 303(g) of the Controlled Substances Act for
purposes of dispensing narcotic drugs to individuals for
maintenance treatment or detoxification treatment and are
in compliance with any regulation promulgated by the
Assistant Secretary for Mental Health and Substance Use for
purposes of carrying out the requirements of such section
303(g); and
``(iii) are qualified under applicable State law to
provide substance use disorder treatment or recovery
services.
``(D) Improved reimbursement for and expansion of, through
the provision of education, training, and technical assistance,
the number or treatment capacity of providers participating
under the State plan (or waiver) that have the qualifications
to address the treatment or recovery needs of--
``(i) individuals enrolled under the State plan (or a
waiver of such plan) who have neonatal abstinence syndrome,
in accordance with guidelines issued by the American
Academy of Pediatrics and American College of Obstetricians
and Gynecologists relating to maternal care and infant care
with respect to neonatal abstinence syndrome;
``(ii) pregnant women, postpartum women, and infants,
particularly the concurrent treatment, as appropriate, and
comprehensive case management of pregnant women, postpartum
women and infants, enrolled under the State plan (or a
waiver of such plan);
``(iii) adolescents and young adults between the ages
of 12 and 21 enrolled under the State plan (or a waiver of
such plan); or
``(iv) American Indian and Alaska Native individuals
enrolled under the State plan (or a waiver of such plan).
``(3) Planning grants.--
``(A) In general.--The Secretary shall, with respect to the
first 18-month period of the demonstration project conducted
under paragraph (1), award planning grants to at least 10
States selected in accordance with subparagraph (B) for
purposes of preparing an application described in paragraph
(4)(C) and carrying out the activities described in
subparagraph (C).
``(B) Selection.--In selecting States for purposes of this
paragraph, the Secretary shall--
``(i) select States that have a State plan (or waiver
of the State plan) approved under this title;
``(ii) select States in a manner that ensures
geographic diversity; and
``(iii) give preference to States with a prevalence of
substance use disorders (in particular opioid use
disorders) that is comparable to or higher than the
national average prevalence, as measured by aggregate per
capita drug overdoses, or any other measure that the
Secretary deems appropriate.
``(C) Activities described.--Activities described in this
subparagraph are, with respect to a State, each of the
following:
``(i) Activities that support the development of an
initial assessment of the behavioral health treatment needs
of the State to determine the extent to which providers are
needed (including the types of such providers and
geographic area of need) to improve the network of
providers that treat substance use disorders under the
State plan (or waiver), including the following:
``(I) An estimate of the number of individuals
enrolled under the State plan (or a waiver of such
plan) who have a substance use disorder.
``(II) Information on the capacity of providers to
provide substance use disorder treatment or recovery
services to individuals enrolled under the State plan
(or waiver), including information on providers who
provide such services and their participation under the
State plan (or waiver).
``(III) Information on the gap in substance use
disorder treatment or recovery services under the State
plan (or waiver) based on the information described in
subclauses (I) and (II).
``(IV) Projections regarding the extent to which
the State participating under the demonstration project
would increase the number of providers offering
substance use disorder treatment or recovery services
under the State plan (or waiver) during the period of
the demonstration project.
``(ii) Activities that, taking into account the results
of the assessment described in clause (i), support the
development of State infrastructure to, with respect to the
provision of substance use disorder treatment or recovery
services under the State plan (or a waiver of such plan),
recruit prospective providers and provide training and
technical assistance to such providers.
``(D) Funding.--For purposes of subparagraph (A), there is
appropriated, out of any funds in the Treasury not otherwise
appropriated, $50,000,000, to remain available until expended.
``(4) Post-planning states.--
``(A) In general.--The Secretary shall, with respect to the
remaining 36-month period of the demonstration project
conducted under paragraph (1), select not more than 5 States in
accordance with subparagraph (B) for purposes of carrying out
the activities described in paragraph (2) and receiving
payments in accordance with paragraph (5).
``(B) Selection.--In selecting States for purposes of this
paragraph, the Secretary shall--
``(i) select States that received a planning grant
under paragraph (3);
``(ii) select States that submit to the Secretary an
application in accordance with the requirements in
subparagraph (C), taking into consideration the quality of
each such application;
``(iii) select States in a manner that ensures
geographic diversity; and
``(iv) give preference to States with a prevalence of
substance use disorders (in particular opioid use
disorders) that is comparable to or higher than the
national average prevalence, as measured by aggregate per
capita drug overdoses, or any other measure that the
Secretary deems appropriate.
``(C) Applications.--
``(i) In general.--A State seeking to be selected for
purposes of this paragraph shall submit to the Secretary,
at such time and in such form and manner as the Secretary
requires, an application that includes such information,
provisions, and assurances, as the Secretary may require,
in addition to the following:
``(I) A proposed process for carrying out the
ongoing assessment described in paragraph (2)(A),
taking into account the results of the initial
assessment described in paragraph (3)(C)(i).
``(II) A review of reimbursement methodologies and
other policies related to substance use disorder
treatment or recovery services under the State plan (or
waiver) that may create barriers to increasing the
number of providers delivering such services.
``(III) The development of a plan, taking into
account activities carried out under paragraph
(3)(C)(ii), that will result in long-term and
sustainable provider networks under the State plan (or
waiver) that will offer a continuum of care for
substance use disorders. Such plan shall include the
following:
``(aa) Specific activities to increase the
number of providers (including providers that
specialize in providing substance use disorder
treatment or recovery services, hospitals, health
care systems, Federally qualified health centers,
and, as applicable, certified community behavioral
health clinics) that offer substance use disorder
treatment, recovery, or support services, including
short-term detoxification services, outpatient
substance use disorder services, and evidence-based
peer recovery services.
``(bb) Strategies that will incentivize
providers described in subparagraphs (C) and (D) of
paragraph (2) to obtain the necessary training,
education, and support to deliver substance use
disorder treatment or recovery services in the
State.
``(cc) Milestones and timeliness for
implementing activities set forth in the plan.
``(dd) Specific measurable targets for
increasing the substance use disorder treatment and
recovery provider network under the State plan (or
a waiver of such plan).
``(IV) A proposed process for reporting the
information required under paragraph (6)(A), including
information to assess the effectiveness of the efforts
of the State to expand the capacity of providers to
deliver substance use disorder treatment or recovery
services during the period of the demonstration project
under this subsection.
``(V) The expected financial impact of the
demonstration project under this subsection on the
State.
``(VI) A description of all funding sources
available to the State to provide substance use
disorder treatment or recovery services in the State.
``(VII) A preliminary plan for how the State will
sustain any increase in the capacity of providers to
deliver substance use disorder treatment or recovery
services resulting from the demonstration project under
this subsection after the termination of such
demonstration project.
``(VIII) A description of how the State will
coordinate the goals of the demonstration project with
any waiver granted (or submitted by the State and
pending) pursuant to section 1115 for the delivery of
substance use services under the State plan, as
applicable.
``(ii) Consultation.--In completing an application
under clause (i), a State shall consult with relevant
stakeholders, including Medicaid managed care plans, health
care providers, and Medicaid beneficiary advocates, and
include in such application a description of such
consultation.
``(5) Payment.--
``(A) In general.--For each quarter occurring during the
period for which the demonstration project is conducted (after
the first 18 months of such period), the Secretary shall pay
under this subsection, subject to subparagraph (C), to each
State selected under paragraph (4) an amount equal to 80
percent of so much of the qualified sums expended during such
quarter.
``(B) Qualified sums defined.--For purposes of subparagraph
(A), the term `qualified sums' means, with respect to a State
and a quarter, the amount equal to the amount (if any) by which
the sums expended by the State during such quarter attributable
to substance use disorder treatment or recovery services
furnished by providers participating under the State plan (or a
waiver of such plan) exceeds 1/4 of such sums expended by the
State during fiscal year 2018 attributable to substance use
disorder treatment or recovery services.
``(C) Non-duplication of payment.--In the case that payment
is made under subparagraph (A) with respect to expenditures for
substance use disorder treatment or recovery services furnished
by providers participating under the State plan (or a waiver of
such plan), payment may not also be made under subsection (a)
with respect to expenditures for the same services so
furnished.
``(6) Reports.--
``(A) State reports.--A State receiving payments under
paragraph (5) shall, for the period of the demonstration
project under this subsection, submit to the Secretary a
quarterly report, with respect to expenditures for substance
use disorder treatment or recovery services for which payment
is made to the State under this subsection, on the following:
``(i) The specific activities with respect to which
payment under this subsection was provided.
``(ii) The number of providers that delivered substance
use disorder treatment or recovery services in the State
under the demonstration project compared to the estimated
number of providers that would have otherwise delivered
such services in the absence of such demonstration project.
``(iii) The number of individuals enrolled under the
State plan (or a waiver of such plan) who received
substance use disorder treatment or recovery services under
the demonstration project compared to the estimated number
of such individuals who would have otherwise received such
services in the absence of such demonstration project.
``(iv) Other matters as determined by the Secretary.
``(B) CMS reports.--
``(i) Initial report.--Not later than October 1, 2020,
the Administrator of the Centers for Medicare & Medicaid
Services shall, in consultation with the Director of the
Agency for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and Substance Use,
submit to Congress an initial report on--
``(I) the States awarded planning grants under
paragraph (3);
``(II) the criteria used in such selection; and
``(III) the activities carried out by such States
under such planning grants.
``(ii) Interim report.--Not later than October 1, 2022,
the Administrator of the Centers for Medicare & Medicaid
Services shall, in consultation with the Director of the
Agency for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and Substance Use,
submit to Congress an interim report--
``(I) on activities carried out under the
demonstration project under this subsection;
``(II) on the extent to which States selected under
paragraph (4) have achieved the stated goals submitted
in their applications under subparagraph (C) of such
paragraph;
``(III) with a description of the strengths and
limitations of such demonstration project; and
``(IV) with a plan for the sustainability of such
project.
``(iii) Final report.--Not later than October 1, 2024,
the Administrator of the Centers for Medicare & Medicaid
Services shall, in consultation with the Director of the
Agency for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and Substance Use,
submit to Congress a final report--
``(I) providing updates on the matters reported in
the interim report under clause (ii);
``(II) including a description of any changes made
with respect to the demonstration project under this
subsection after the submission of such interim report;
and
``(III) evaluating such demonstration project.
``(C) AHRQ report.--Not later than 3 years after the date
of the enactment of this subsection, the Director of the Agency
for Healthcare Research and Quality, in consultation with the
Administrator of the Centers for Medicare & Medicaid Services,
shall submit to Congress a summary on the experiences of States
awarded planning grants under paragraph (3) and States selected
under paragraph (4).
``(7) Data sharing and best practices.--During the period of
the demonstration project under this subsection, the Secretary
shall, in collaboration with States selected under paragraph (4),
facilitate data sharing and the development of best practices
between such States and States that were not so selected.
``(8) CMS funding.--There is appropriated, out of any funds in
the Treasury not otherwise appropriated, $5,000,000 to the Centers
for Medicare & Medicaid Services for purposes of implementing this
subsection. Such amount shall remain available until expended.''.
SEC. 1004. MEDICAID DRUG REVIEW AND UTILIZATION.
(a) Medicaid Drug Utilization Review.--
(1) State plan requirement.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)), as amended by section 1001, is
further amended--
(A) in paragraph (83), at the end, by striking ``and'';
(B) in paragraph (84), at the end, by striking the period
and inserting ``; and''; and
(C) by inserting after paragraph (84) the following new
paragraph:
``(85) provide that the State is in compliance with the drug
review and utilization requirements under subsection (oo)(1).''.
(2) Drug review and utilization requirements.--Section 1902 of
the Social Security Act (42 U.S.C. 1396a), as amended by section
1001, is further amended by adding at the end the following new
subsection:
``(oo) Drug Review and Utilization Requirements.--
``(1) In general.--For purposes of subsection (a)(85), the drug
review and utilization requirements under this subsection are,
subject to paragraph (3) and beginning October 1, 2019, the
following:
``(A) Claims review limitations.--
``(i) In general.--The State has in place--
``(I) safety edits (as specified by the State) for
subsequent fills for opioids and a claims review
automated process (as designed and implemented by the
State) that indicates when an individual enrolled under
the State plan (or under a waiver of the State plan) is
prescribed a subsequent fill of opioids in excess of
any limitation that may be identified by the State;
``(II) safety edits (as specified by the State) on
the maximum daily morphine equivalent that can be
prescribed to an individual enrolled under the State
plan (or under a waiver of the State plan) for
treatment of chronic pain and a claims review automated
process (as designed and implemented by the State) that
indicates when an individual enrolled under the plan
(or waiver) is prescribed the morphine equivalent for
such treatment in excess of any limitation that may be
identified by the State; and
``(III) a claims review automated process (as
designed and implemented by the State) that monitors
when an individual enrolled under the State plan (or
under a waiver of the State plan) is concurrently
prescribed opioids and--
``(aa) benzodiazepines; or
``(bb) antipsychotics.
``(ii) Managed care entities.--The State requires each
managed care entity (as defined in section 1932(a)(1)(B))
with respect to which the State has a contract under
section 1903(m) or under section 1905(t)(3) to have in
place, subject to paragraph (3), with respect to
individuals who are eligible for medical assistance under
the State plan (or under a waiver of the State plan) and
who are enrolled with the entity, the limitations described
in subclauses (I) and (II) of clause (i) and a claims
review automated process described in subclause (III) of
such clause.
``(iii) Rules of construction.--Nothing in this
subparagraph may be construed as prohibiting a State or
managed care entity from designing and implementing a
claims review automated process under this subparagraph
that provides for prospective or retrospective reviews of
claims. Nothing in this subparagraph shall be understood as
prohibiting the exercise of clinical judgment from a
provider enrolled as a participating provider in a State
plan (or waiver of the State plan) or contracting with a
managed care entity regarding the best items and services
for an individual enrolled under such State plan (or
waiver).
``(B) Program to monitor antipsychotic medications by
children.--The State has in place a program (as designed and
implemented by the State) to monitor and manage the appropriate
use of antipsychotic medications by children enrolled under the
State plan (or under a waiver of the State plan) and submits
annually to the Secretary such information as the Secretary may
require on activities carried out under such program for
individuals not more than the age of 18 years generally and
children in foster care specifically.
``(C) Fraud and abuse identification.--The State has in
place a process (as designed and implemented by the State) that
identifies potential fraud or abuse of controlled substances by
individuals enrolled under the State plan (or under a waiver of
the State plan), health care providers prescribing drugs to
individuals so enrolled, and pharmacies dispensing drugs to
individuals so enrolled.
``(D) Reports.--The State shall include in the annual
report submitted to the Secretary under section 1927(g)(3)(D)
information on the limitations, requirement, program, and
processes applied by the State under subparagraphs (A) through
(C) in accordance with such manner and time as specified by the
Secretary.
``(E) Clarification.--Nothing shall prevent a State from
satisfying the requirement--
``(i) described in subparagraph (A) by having safety
edits or a claims review automated process described in
such subparagraph that was in place before October 1, 2019;
``(ii) described in subparagraph (B) by having a
program described in such subparagraph that was in place
before such date; or
``(iii) described in subparagraph (C) by having a
process described in such subparagraph that was in place
before such date.
``(2) Annual report by secretary.--For each fiscal year
beginning with fiscal year 2020, the Secretary shall submit to
Congress a report on the most recent information submitted by
States under paragraph (1)(D).
``(3) Exceptions.--
``(A) Certain individuals exempted.--The drug review and
utilization requirements under this subsection shall not apply
with respect to an individual who--
``(i) is receiving--
``(I) hospice or palliative care; or
``(II) treatment for cancer;
``(ii) is a resident of a long-term care facility, of a
facility described in section 1905(d), or of another
facility for which frequently abused drugs are dispensed
for residents through a contract with a single pharmacy; or
``(iii) the State elects to treat as exempted from such
requirements.
``(B) Exception relating to ensuring access.--In order to
ensure reasonable access to health care, the Secretary shall
waive the drug review and utilization requirements under this
subsection, with respect to a State, in the case of natural
disasters and similar situations, and in the case of the
provision of emergency services (as defined for purposes of
section 1860D-4(c)(5)(D)(ii)(II)).''.
(3) Managed care entities.--Section 1932 of the Social Security
Act (42 U.S.C. 1396u-2) is amended by adding at the end the
following new subsection:
``(i) Drug Utilization Review Activities and Requirements.--
Beginning not later than October 1, 2019, each contract under a State
plan with a managed care entity (other than a primary care case
manager) under section 1903(m) shall provide that the entity is in
compliance with the applicable provisions of section 438.3(s)(2) of
title 42, Code of Federal Regulations, section 483.3(s)(4)) of such
title, and section 483.3(s)(5) of such title, as such provisions were
in effect on March 31, 2018.''.
(b) Identifying and Addressing Inappropriate Prescribing and
Billing Practices Under Medicaid.--
(1) In general.--Section 1927(g) of the Social Security Act (42
U.S.C. 1396r-8(g)) is amended--
(A) in paragraph (1)(A)--
(i) by striking ``of section 1903(i)(10)(B)'' and
inserting ``of section 1902(a)(54)'';
(ii) by striking ``, by not later than January 1,
1993,'';
(iii) by inserting after ``gross overuse,'' the
following: ``excessive utilization,''; and
(iv) by striking ``or inappropriate or medically
unnecessary care'' and inserting ``inappropriate or
medically unnecessary care, or prescribing or billing
practices that indicate abuse or excessive utilization'';
and
(B) in paragraph (2)(B)--
(i) by inserting after ``gross overuse,'' the
following: ``excessive utilization,''; and
(ii) by striking ``or inappropriate or medically
unnecessary care'' and inserting ``inappropriate or
medically unnecessary care, or prescribing or billing
practices that indicate abuse or excessive utilization''.
(2) Effective date.--The amendments made by paragraph (1) shall
take effect with respect to retrospective drug use reviews
conducted on or after October 1, 2020.
SEC. 1005. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL
ABSTINENCE SYNDROME AND THEIR MOTHERS; GAO STUDY ON GAPS IN MEDICAID
COVERAGE FOR PREGNANT AND POSTPARTUM WOMEN WITH SUBSTANCE USE DISORDER.
(a) Guidance.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidance to improve care for infants with neonatal abstinence
syndrome and their families. Such guidance shall include--
(1) best practices from States with respect to innovative or
evidenced-based payment models that focus on prevention, screening,
treatment, plans of safe care, and postdischarge services for
mothers and fathers with substance use disorders and babies with
neonatal abstinence syndrome that improve care and clinical
outcomes;
(2) recommendations for States on available financing options
under the Medicaid program under title XIX of such Act and under
the Children's Health Insurance Program under title XXI of such Act
for Children's Health Insurance Program Health Services Initiative
funds for parents with substance use disorders, infants with
neonatal abstinence syndrome, and home-visiting services;
(3) guidance and technical assistance to State Medicaid
agencies regarding additional flexibilities and incentives related
to screening, prevention, and postdischarge services, including
parenting supports, and infant-caregiver bonding, including
breastfeeding when it is appropriate; and
(4) guidance regarding suggested terminology and ICD codes to
identify infants with neonatal abstinence syndrome and neonatal
opioid withdrawal syndrome, which could include opioid-exposure,
opioid withdrawal not requiring pharmacotherapy, and opioid
withdrawal requiring pharmacotherapy.
(b) GAO Study.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General of the United States
shall conduct a study, and submit to Congress a report, addressing gaps
in coverage for pregnant women with substance use disorder under the
Medicaid program under title XIX of the Social Security Act, and gaps
in coverage for postpartum women with substance use disorder who had
coverage during their pregnancy under the Medicaid program under such
title.
SEC. 1006. MEDICAID HEALTH HOMES FOR SUBSTANCE-USE-DISORDER MEDICAID
ENROLLEES.
(a) Extension of Enhanced FMAP for Certain Health Homes for
Individuals With Substance Use Disorders.--Section 1945(c) of the
Social Security Act (42 U.S.C. 1396w-4(c)) is amended--
(1) in paragraph (1), by inserting ``subject to paragraph
(4),'' after ``except that,''; and
(2) by adding at the end the following new paragraph:
``(4) Special rule relating to substance use disorder health
homes.--
``(A) In general.--In the case of a State with an SUD-
focused State plan amendment approved by the Secretary on or
after October 1, 2018, the Secretary may, at the request of the
State, extend the application of the Federal medical assistance
percentage described in paragraph (1) to payments for the
provision of health home services to SUD-eligible individuals
under such State plan amendment, in addition to the first 8
fiscal year quarters the State plan amendment is in effect, for
the subsequent 2 fiscal year quarters that the State plan
amendment is in effect. Nothing in this section shall be
construed as prohibiting a State with a State plan amendment
that is approved under this section and that is not an SUD-
focused State plan amendment from additionally having approved
on or after such date an SUD-focused State plan amendment under
this section, including for purposes of application of this
paragraph.
``(B) Report requirements.--In the case of a State with an
SUD-focused State plan amendment for which the application of
the Federal medical assistance percentage has been extended
under subparagraph (A), such State shall, at the end of the
period of such State plan amendment, submit to the Secretary a
report on the following, with respect to SUD-eligible
individuals provided health home services under such State plan
amendment:
``(i) The quality of health care provided to such
individuals, with a focus on outcomes relevant to the
recovery of each such individual.
``(ii) The access of such individuals to health care.
``(iii) The total expenditures of such individuals for
health care.
For purposes of this subparagraph, the Secretary shall specify
all applicable measures for determining quality, access, and
expenditures.
``(C) Best practices.--Not later than October 1, 2020, the
Secretary shall make publicly available on the internet website
of the Centers for Medicare & Medicaid Services best practices
for designing and implementing an SUD-focused State plan
amendment, based on the experiences of States that have State
plan amendments approved under this section that include SUD-
eligible individuals.
``(D) Definitions.--For purposes of this paragraph:
``(i) SUD-eligible individuals.--The term `SUD-eligible
individual' means, with respect to a State, an individual
who satisfies all of the following:
``(I) The individual is an eligible individual with
chronic conditions.
``(II) The individual is an individual with a
substance use disorder.
``(III) The individual has not previously received
health home services under any other State plan
amendment approved for the State under this section by
the Secretary.
``(ii) SUD-focused state plan amendment.--The term
`SUD-focused State plan amendment' means a State plan
amendment under this section that is designed to provide
health home services primarily to SUD-eligible
individuals.''.
(b) Requirement for State Medicaid Plans To Provide Coverage for
Medication-Assisted Treatment.--
(1) Requirement for state medicaid plans to provide coverage
for medication-assisted treatment.--Section 1902(a)(10)(A) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended, in the
matter preceding clause (i), by striking ``and (28)'' and inserting
``(28), and (29)''.
(2) Inclusion of medication-assisted treatment as medical
assistance.--Section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) is amended--
(A) in paragraph (28), by striking ``and'' at the end;
(B) by redesignating paragraph (29) as paragraph (30); and
(C) by inserting after paragraph (28) the following new
paragraph:
``(29) subject to paragraph (2) of subsection (ee), for the
period beginning October 1, 2020, and ending September 30, 2025,
medication-assisted treatment (as defined in paragraph (1) of such
subsection); and''.
(3) Medication-assisted treatment defined; waivers.--Section
1905 of the Social Security Act (42 U.S.C. 1396d) is amended by
adding at the end the following new subsection:
``(ee) Medication-Assisted Treatment.--
``(1) Definition.--For purposes of subsection (a)(29), the term
`medication-assisted treatment'--
``(A) means all drugs approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), including
methadone, and all biological products licensed under section
351 of the Public Health Service Act (42 U.S.C. 262) to treat
opioid use disorders; and
``(B) includes, with respect to the provision of such drugs
and biological products, counseling services and behavioral
therapy.
``(2) Exception.--The provisions of paragraph (29) of
subsection (a) shall not apply with respect to a State for the
period specified in such paragraph, if before the beginning of such
period the State certifies to the satisfaction of the Secretary
that implementing such provisions statewide for all individuals
eligible to enroll in the State plan (or waiver of the State plan)
would not be feasible by reason of a shortage of qualified
providers of medication-assisted treatment, or facilities providing
such treatment, that will contract with the State or a managed care
entity with which the State has a contract under section 1903(m) or
under section 1905(t)(3).''.
(4) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with respect to
medical assistance provided on or after October 1, 2020, and
before October 1, 2025.
(B) Exception for state legislation.--In the case of a
State plan under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.) that the Secretary of Health and Human
Services determines requires State legislation in order for the
respective plan to meet any requirement imposed by the
amendments made by this subsection, the respective plan shall
not be regarded as failing to comply with the requirements of
such title solely on the basis of its failure to meet such an
additional requirement 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 the session shall be considered to be a
separate regular session of the State legislature.
SEC. 1007. CARING RECOVERY FOR INFANTS AND BABIES.
(a) State Plan Amendment.--Section 1902(a) of the Social Security
Act (42 U.S.C. 1396a(a)), as amended by sections 1001 and 1004, is
further amended--
(1) in paragraph (84)(C), by striking ``and'' after the
semicolon;
(2) in paragraph (85), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after paragraph (85), the following new
paragraph:
``(86) 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
(pp)) to infants with neonatal abstinence syndrome.''.
(b) Residential Pediatric Recovery Center Defined.--Section 1902 of
such Act (42 U.S.C. 1396a), as amended by sections 1001 and 1004, is
further amended by adding at the end the following new subsection:
``(pp) Residential Pediatric Recovery Center Defined.--
``(1) In general.--For purposes of section 1902(a)(86), 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. 1008. 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. 1009. 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) 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 Services Delivered Via Telehealth, 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, medication management, and medication adherence with
prescribed medication regimes, using services delivered via
telehealth. 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 non-fatal overdose.
(D) Individuals with a co-occurring serious mental illness
and substance use disorder.
(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 services delivered via telehealth.
(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 services
delivered via telehealth, 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 Services Delivered Via
Telehealth 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
Representatives identifying best practices and potential solutions
for reducing barriers to using services delivered via telehealth 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 services delivered via telehealth 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 services delivered via telehealth
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. 1010. 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. 1011. 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. 1012. HELP FOR MOMS AND BABIES.
(a) Medicaid State Plan.--Section 1905(a) of the Social Security
Act (42 U.S.C. 1396d(a)), as amended by section 1006, is further
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 (30) 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. 1013. 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. 1014. 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. 1015. 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 United States 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-based 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-based 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-based
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 United States
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. 1016. 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 1013, is further 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 (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. 1017. 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-based 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. 1018. 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).
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 2001. 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 July 1, 2019, to an eligible
telehealth individual with a substance use disorder diagnosis for
purposes of treatment of such disorder or co-occurring mental
health 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.--
(1) In general.--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--
(A) 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
(B) health outcomes related to substance use disorders,
such as opioid overdose deaths.
(2) Funding.--For purposes of carrying out paragraph (1), in
addition to funds otherwise available, the Secretary shall provide
for the transfer, from the Federal Supplementary Medical Insurance
Trust Fund under section 1841, of $3,000,000 to the Centers for
Medicare & Medicaid Services Program Management Account to remain
available until expended.
SEC. 2002. 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 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) Rule of Construction.--Nothing in the amendments made by
subsection (a) or (b) shall be construed to prohibit separate payment
for structured assessment and intervention services for substance abuse
furnished to an individual on the same day as an initial preventive
physical examination or an annual wellness visit.
(d) Effective Date.--The amendments made by this section shall
apply to examinations and visits furnished on or after January 1, 2020.
SEC. 2003. 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.
(c) Update of Biometric Component of Multifactor Authentication.--
Not later than 1 year after the date of enactment of this Act, the
Attorney General shall update the requirements for the biometric
component of multifactor authentication with respect to electronic
prescriptions of controlled substances.
SEC. 2004. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER MEDICARE TO
ESTABLISH DRUG MANAGEMENT PROGRAMS FOR AT-RISK BENEFICIARIES.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (E) the
following new subparagraph:
``(F) With respect to plan years beginning on or after
January 1, 2022, a drug management program for at-risk
beneficiaries described in paragraph (5).''; and
(2) in paragraph (5)(A), by inserting ``(and for plan years
beginning on or after January 1, 2022, a PDP sponsor shall)'' after
``A PDP sponsor may''.
SEC. 2005. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY OPIOID
TREATMENT PROGRAMS.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (FF), by striking at the end ``and'';
(2) in subparagraph (GG), by inserting at the end ``and''; and
(3) by adding at the end the following new subparagraph:
``(HH) opioid use disorder treatment services (as defined in
subsection (jjj)).''.
(b) Opioid Use Disorder Treatment Services and Opioid Treatment
Program Defined.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended by adding at the end the following new subsection:
``(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment
Program.--
``(1) 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--
``(A) 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;
``(B) dispensing and administration of such medications, if
applicable;
``(C) substance use counseling by a professional to the
extent authorized under State law to furnish such services;
``(D) individual and group therapy with a physician or
psychologist (or other mental health professional to the extent
authorized under State law);
``(E) toxicology testing, and
``(F) other items and services that the Secretary
determines are appropriate (but in no event to include meals or
transportation).
``(2) 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--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the Substance Abuse
and Mental Health Services Administration for such a program;
``(C) is accredited by an accrediting body approved by the
Substance Abuse and Mental Health Services Administration; and
``(D) meets such additional conditions as the Secretary may
find necessary to ensure--
``(i) the health and safety of individuals being
furnished services under such program; and
``(ii) the effective and efficient furnishing of such
services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security Act
(42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (bb)'' and inserting ``(bb)''; and
(B) by inserting before the semicolon at the end the
following ``, and (cc) with respect to opioid use disorder
treatment services furnished during an episode of care, the
amount paid shall be equal to the amount payable under section
1834(w) less any copayment required as specified by the
Secretary''.
(2) Payment determination.--Section 1834 of the Social Security
Act (42 U.S.C. 1395m) is amended by adding at the end the following
new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a bundled
payment under this part for opioid use disorder treatment services
(as defined in paragraph (1) of such section) that are furnished by
such program to an individual during an episode of care (as defined
by the Secretary) beginning on or after January 1, 2020. The
Secretary shall ensure, as determined appropriate by the Secretary,
that no duplicative payments are made under this part or part D for
items and services furnished by an opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection 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, the scope of
services furnished, characteristics of the individuals furnished
such services, or other factors as the Secretary determine
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.
``(3) Annual updates.--The Secretary shall provide an update
each year to the bundled payment amounts under this subsection.''.
(d) Including Opioid Treatment Programs as Medicare Providers.--
Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is
amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph (2) of
section 1861(jjj)), but only with respect to the furnishing of
opioid use disorder treatment services (as defined in paragraph (1)
of such section).''.
SEC. 2006. 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. 2007. 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. 2008. SUSPENSION OF PAYMENTS BY MEDICARE PRESCRIPTION DRUG PLANS
AND MA-PD PLANS PENDING INVESTIGATIONS OF CREDIBLE ALLEGATIONS OF FRAUD
BY PHARMACIES.
(a) In General.--Section 1860D-12(b) of the Social Security Act (42
U.S.C. 1395w-112(b)) is amended by adding at the end the following new
paragraph:
``(7) Suspension of payments pending investigation of credible
allegations of fraud by pharmacies.--
``(A) In general.--Section 1862(o)(1) shall apply with
respect to a PDP sponsor with a contract under this part, a
pharmacy, and payments to such pharmacy under this part in the
same manner as such section applies with respect to the
Secretary, a provider of services or supplier, and payments to
such provider of services or supplier under this title. A PDP
sponsor shall notify the Secretary regarding the imposition of
any payment suspension pursuant to the previous sentence, such
as through the secure internet website portal (or other
successor technology) established under section 1859(i).
``(B) Rule of construction.--Nothing in this paragraph
shall be construed as limiting the authority of a PDP sponsor
to conduct postpayment review.''.
(b) Application to MA-PD Plans.--Section 1857(f)(3) of the Social
Security Act (42 U.S.C. 1395w-27(f)(3)) is amended by adding at the end
the following new subparagraph:
``(D) Suspension of payments pending investigation of
credible allegations of fraud by pharmacies.--Section 1860D-
12(b)(7).''.
(c) Conforming Amendment.--Section 1862(o)(3) of the Social
Security Act (42 U.S.C. 1395y(o)(3)) is amended by inserting ``,
section 1860D-12(b)(7) (including as applied pursuant to section
1857(f)(3)(D)),'' after ``this subsection''.
(d) Clarification Relating to Credible Allegation of Fraud.--
Section 1862(o) of the Social Security Act (42 U.S.C. 1395y(o)) is
amended by adding at the end the following new paragraph:
``(4) Credible allegation of fraud.--In carrying out this
subsection, section 1860D-12(b)(7) (including as applied pursuant
to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud
hotline tip (as defined by the Secretary) without further evidence
shall not be treated as sufficient evidence for a credible
allegation of fraud.''.
(e) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2020.
TITLE III--FDA AND CONTROLLED SUBSTANCE PROVISIONS
Subtitle A--FDA Provisions
CHAPTER 1--IN GENERAL
SEC. 3001. 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 of Health and Human Services
(referred to in this section as 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 acute or chronic 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
intended to treat acute or chronic pain; 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
acute or chronic pain, including--
(A) alternative 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)),
including patient registries and patient reported outcomes, 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 intended
to treat acute or chronic pain.
SEC. 3002. EVIDENCE-BASED OPIOID ANALGESIC PRESCRIBING GUIDELINES AND
REPORT.
(a) Guidelines.--The Commissioner of Food and Drugs shall develop
evidence-based opioid analgesic prescribing guidelines for the
indication-specific treatment of acute pain only for the relevant
therapeutic areas where such guidelines do not exist.
(b) Public Input.--In developing the guidelines under subsection
(a), the Commissioner of Food and Drugs shall--
(1) consult with stakeholders, which may include conducting a
public meeting of medical professional societies (including any
State-based societies), health care providers, State medical
boards, medical specialties including pain medicine specialty
societies, patient groups, pharmacists, academic or medical
research entities, and other entities with experience in health
care, as appropriate;
(2) collaborate with the Director of the Centers for Disease
Control and Prevention, as applicable and appropriate, and other
Federal agencies with relevant expertise as appropriate; and
(3) provide for a notice and comment period consistent with
section 701(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 371(h)) for the submission of comments by the public.
(c) Report.--Not later than 1 year after the date of enactment of
this Act, or, if earlier, at the time the guidelines under subsection
(a) are finalized, the Commissioner of Food and Drugs shall submit to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate, and post on the public website of the Food and Drug
Administration, a report on how the Food and Drug Administration will
utilize the guidelines under subsection (a) to protect the public
health and a description of the public health need with respect to each
such indication-specific treatment guideline.
(d) Updates.--The Commissioner of Food and Drugs shall
periodically--
(1) update the guidelines under subsection (a), informed by
public input described in subsection (b); and
(2) submit to the committees specified in subsection (c) and
post on the public website of the Food and Drug Administration an
updated report under such subsection.
(e) Statement To Accompany Guidelines and Recommendations.--The
Commissioner of Food and Drugs shall ensure that opioid analgesic
prescribing guidelines and other recommendations developed under this
section are accompanied by a clear statement that such guidelines or
recommendations, as applicable--
(1) are intended to help inform clinical decisionmaking by
prescribers and patients; and
(2) are not intended to be used for the purposes of
restricting, limiting, delaying, or denying coverage for, or access
to, a prescription issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional
practice.
CHAPTER 2--STOP COUNTERFEIT DRUGS BY REGULATING AND ENHANCING
ENFORCEMENT NOW
SEC. 3011. SHORT TITLE.
This chapter may be cited as the ``Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act'' or the ``SCREEN Act''.
SEC. 3012. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CONTROLLED
SUBSTANCES.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(eee) The failure to comply with any order issued under section
569D.''.
(b) Notification, Nondistribution, and Recall of Controlled
Substances.--Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end
the following:
``SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CONTROLLED
SUBSTANCES.
``(a) Order To Cease Distribution and Recall.--
``(1) In general.--If the Secretary determines there is a
reasonable probability that a controlled substance would cause
serious adverse health consequences or death, the Secretary may,
after providing the appropriate person with an opportunity to
consult with the agency, issue an order requiring manufacturers,
importers, distributors, or pharmacists, who distribute such
controlled substance to immediately cease distribution of such
controlled substance.
``(2) Hearing.--An order under paragraph (1) shall provide the
person subject to the order with an opportunity for an informal
hearing, to be held not later than 10 days after the date of
issuance of the order, on whether adequate evidence exists to
justify an amendment to the order, and what actions are required by
such amended order pursuant to subparagraph (3).
``(3) Order resolution.--After an order is issued according to
the process under paragraphs (1) and (2), the Secretary shall,
except as provided in paragraph (4)--
``(A) vacate the order, if the Secretary determines that
inadequate grounds exist to support the actions required by the
order;
``(B) continue the order ceasing distribution of the
controlled substance until a date specified in such order; or
``(C) amend the order to require a recall of the controlled
substance, including any requirements to notify appropriate
persons, a timetable for the recall to occur, and a schedule
for updates to be provided to the Secretary regarding such
recall.
``(4) Risk assessment.--If the Secretary determines that the
risk of recalling a controlled substance presents a greater health
risk than the health risk of not recalling such controlled
substance from use, an amended order under subparagraph (B) or (C)
of paragraph (3) shall not include either a recall order for, or an
order to cease distribution of, such controlled substance, as
applicable.
``(5) Action following order.--Any person who is subject to an
order pursuant to subparagraph (B) or (C) of paragraph (3) shall
immediately cease distribution of or recall, as applicable, the
controlled substance and provide notification as required by such
order.
``(b) Notice to Persons Affected.--If the Secretary determines
necessary, the Secretary may require the person subject to an order
pursuant to paragraph (1) or an amended order pursuant to subparagraph
(B) or (C) of paragraph (3) to provide either a notice of a recall
order for, or an order to cease distribution of, such controlled
substance, as applicable, under this section to appropriate persons,
including persons who manufacture, distribute, import, or offer for
sale such product that is the subject of an order and to the public. In
providing such notice, the Secretary may use the assistance of health
professionals who prescribed or dispensed such controlled substances.
``(c) Nondelegation.--An order described in subsection (a)(3) shall
be ordered by the Secretary or an official designated by the Secretary.
An official may not be so designated under this section unless the
official is the Director of the Center for Drug Evaluation and Research
or an official senior to such Director.
``(d) Savings Clause.--Nothing contained in this section shall be
construed as limiting--
``(1) the authority of the Secretary to issue an order to cease
distribution of, or to recall, any drug under any other provision
of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any drug subject to this
Act or the Public Health Service Act.''.
(c) Controlled Substances Subject to Refusal.--The third sentence
of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(a)) is amended by inserting ``, or is a controlled substance
subject to an order under section 569D'' before ``, or (4)''.
(d) Effective Date.--Sections 301(eee) and 569D of the Federal
Food, Drug, and Cosmetic Act, as added by subsections (a) and (b),
shall be effective beginning on the date of enactment of this Act.
SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL DRUGS.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381), as amended by section 3012, is further amended by adding at the
end the following:
``(t) Single Source Pattern of Imported Illegal Drugs.--If the
Secretary determines that a person subject to debarment as a result of
engaging in a pattern of importing or offering for import controlled
substances or drugs as described in section 306(b)(3)(D), and such
pattern is identified by the Secretary as being offered for import from
the same manufacturer, distributor, or importer, the Secretary may by
order determine all drugs being offered for import from such person as
adulterated or misbranded, unless such person can provide evidence
otherwise.''.
SEC. 3014. STRENGTHENING FDA AND CBP COORDINATION AND CAPACITY.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as 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 in response to illegal controlled substances and drug
imports, including at sites of import (such as international mail
facilities), that will provide improvements to such facilities,
technologies, and inspection capacity. 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) improvements in equipment and information
technology enhancement to identify unapproved, counterfeit,
or other unlawful controlled substances for destruction;
(iii) the construction of, or upgrades to, laboratory
capacity for purposes of detection and testing of imported
goods;
(iv) upgrades to the security of import facilities; and
(v) 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 and
practicable.
(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 Committee on Energy and Commerce and the
Committee on Homeland Security of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the Committee
on Homeland Security and Governmental Affairs of the Senate on the
implementation of this section, including a summary of progress made
toward near-real-time information sharing and the interoperability of
such technologies.
CHAPTER 3--STOP ILLICIT DRUG IMPORTATION
SEC. 3021. SHORT TITLE.
This chapter may be cited as the ``Stop Illicit Drug Importation
Act of 2018''.
SEC. 3022. RESTRICTING ENTRANCE OF ILLICIT DRUGS.
(a) Food and Drug Administration and U.S. Customs and Border
Protection Cooperation.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through
the Commissioner of Food and Drugs and in consultation with the
U.S. Customs and Border Protection, shall develop and periodically
update a mutually agreed upon list of the controlled substances
that the Secretary will refer to U.S. Customs and Border
Protection, unless the Secretary and U.S. Customs and Border
Protection agree otherwise, when such substances are offered for
import via international mail and appear to violate 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. The Secretary shall transfer controlled substances
on such list 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.).
(2) Report.--Not later than 9 months after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs and in consultation with the
Secretary of Homeland Security, shall report to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate
on the implementation of this section.
(b) Debarment, Temporary Denial of Approval, and Suspension.--
(1) Prohibited act.--Section 301(cc) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(cc)) is amended--
(A) by inserting ``or a drug'' after ``food''; and
(B) by inserting ``from such activity'' after ``person
debarred''.
(2) Debarment.--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.'';
(B) in paragraph (3)--
(i) in the heading, by inserting ``or drug'' after
``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.''; and
(C) by adding at the end the following:
``(5) Definition.--For purposes of paragraph (3)(D), the term
`pattern of importing or offering for import' means importing or
offering for import a drug described in clause (i) or (ii) of
paragraph (3)(D) in an amount, frequency, or dosage that is
inconsistent with personal or household use by the importer.''.
(c) Imports and Exports.--Section 801(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(a)), as amended, is further amended--
(1) by striking ``, then such article shall be refused
admission'' inserting ``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) shall be
refused admission'';
(2) by inserting ``If it appears from the examination of such
samples or otherwise that the article is a counterfeit drug, such
article shall be refused admission.'' before ``With respect to an
article of food, if importation''; and
(3) 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 third
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), as amended, is amended by
adding at the end the following--
``(u) 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, a dietary supplement, or other product
that is regulated under this Act); 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 has
been authorized 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).''.
CHAPTER 4--SECURING OPIOIDS AND UNUSED NARCOTICS WITH DELIBERATE
DISPOSAL AND PACKAGING
SEC. 3031. SHORT TITLE.
This chapter may be cited as the ``Securing Opioids and Unused
Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the
``SOUND Disposal and Packaging Act''.
SEC. 3032. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.
(a) Deliberate Disposal and Packaging 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 disposal 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 nonretrievable (as defined in section 1300.05
of title 21, Code of Federal Regulations (or any successor
regulation)) if the Secretary determines that such safe
disposal packaging or system may mitigate such serious risk and
is sufficiently available.''.
(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 limitations; 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''.
(d) GAO Report.--Not later than 12 months after the date of
enactment of this Act, the Comptroller General of the United States
shall prepare and submit to Congress a report containing--
(1) a description of available evidence, if any, on the
effectiveness of site-of-use, in-home controlled substance disposal
products and packaging technologies;
(2) an evaluation of existing reference standards with respect
to controlled substance disposal products and packaging
technologies, including any such standards established by a
standards development organization, and how such standards should
be considered in ensuring effectiveness of such products and
technologies;
(3) identification of ways in which such disposal products
intended for use by patients, consumers, and other end users that
are not registrants under the Controlled Substances Act (21 U.S.C.
801 et seq.), are made available to the public and any barriers to
the use of such disposal products;
(4) identification of ways in which packaging technologies are
made available to the public and any barriers to the use of such
technologies;
(5) a description of current Federal oversight, if any, of
site-of-use, in-home controlled substance disposal products,
including--
(A) identification of the Federal agencies that oversee
such products;
(B) identification of the methods of disposal of controlled
substances recommended by such agencies for site-of-use, in-
home disposal; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances;
(6) a description of current Federal oversight, if any, of
controlled substance packaging technologies, including--
(A) identification of the Federal agencies that oversee
such technologies;
(B) identification of the technologies recommended by such
agencies, including unit dose packaging, packaging that
provides a set duration, and other packaging systems that may
mitigate abuse or misuse; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances; and
(7) recommendations, as appropriate, on--
(A) whether site-of-use, in-home controlled substance
disposal products and packaging technologies require Federal
oversight and, if so, which agency or agencies should be
responsible for such oversight and, as applicable, review of
such products or technologies; and
(B) whether there are applicable standards that should be
considered to ensure the effectiveness of such products.
CHAPTER 5--POSTAPPROVAL STUDY REQUIREMENTS
SEC. 3041. CLARIFYING FDA POSTMARKET AUTHORITIES.
(a) Definition of Adverse Drug Experience.--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''.
(b) Safety Labeling Changes.--Section 505(o)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended--
(1) in subparagraph (A) by--
(A) striking ``Safety information'' and inserting ``Safety
or new effectiveness information''; and
(B) by striking ``If the Secretary becomes'' and all that
follows through ``in the labeling of the drug'' and inserting
``If the Secretary becomes aware of new information, including
any new safety information or information related to reduced
effectiveness, that the Secretary determines should be included
in the labeling of the drug'';
(2) in clause (i) of subparagraph (B), by inserting before the
semicolon ``, or new effectiveness information'';
(3) in subparagraph (C) by striking ``safety information'' and
inserting ``safety or new effectiveness information''; and
(4) in subparagraph (E) by striking ``safety information'' and
inserting ``safety or new effectiveness information''.
(c) Guidance.--Not less than one year after the date of enactment
of this Act, the Secretary of Health and Human Services shall issue
guidance regarding the circumstances under which the Food and Drug
Administration may require postmarket studies or clinical trials to
assess the potential reduction in effectiveness of a drug and how such
reduction in effectiveness could result in a change to the benefits of
the drug and the risks to the patient. Such guidance shall also address
how the Food and Drug Administration may apply this section and the
amendments made thereby with respect to circumstances under which the
Food and Drug Administration may require postmarket studies or clinical
trials and safety labeling changes related to the use of controlled
substances for acute or chronic pain.
Subtitle B--Controlled Substance Provisions
CHAPTER 1--MORE FLEXIBILITY WITH RESPECT TO MEDICATION-ASSISTED
TREATMENT FOR OPIOID USE DISORDERS
SEC. 3201. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO MEDICATION-
ASSISTED TREATMENT FOR OPIOID USE DISORDERS.
(a) Conforming Applicable Number.--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;
``(bb) 100 if the practitioner holds additional
credentialing, as defined in section 8.2 of title 42, Code of
Federal Regulations (or successor regulations);
``(cc) 100 if the practitioner provides medication-assisted
treatment (MAT) using covered medications (as such terms are
defined in section 8.2 of title 42, Code of Federal Regulations
(or successor regulations)) in a qualified practice setting (as
described in section 8.615 of title 42, Code of Federal
Regulations (or successor regulations)); or
``(dd) 275 if the practitioner meets the requirements
specified in sections 8.610 through 8.655 of title 42, Code of
Federal Regulations (or successor regulations).''.
(b) Eliminating Any Time Limitation for Nurse Practitioners and
Physician Assistants To Become Qualifying Practitioners.--Clause (iii)
of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)) is amended--
(1) in subclause (I), by striking ``or'' at the end; and
(2) by amending subclause (II) to read as follows:
``(II) a qualifying other practitioner, as defined in
clause (iv), who is a nurse practitioner or physician
assistant; or''.
(c) Imposing a Time Limitation for Clinical Nurse Specialists,
Certified Registered Nurse Anesthetists, and Certified Nurse Midwifes
To Become Qualifying Practitioners.--Clause (iii) of section
303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)),
as amended by subsection (b), is further amended by adding at the end
the following:
``(III) for the period beginning on October 1, 2018, and
ending on October 1, 2023, a qualifying other practitioner, as
defined in clause (iv), who is a clinical nurse specialist,
certified registered nurse anesthetist, or certified nurse
midwife.''.
(d) Definition of Qualifying Other Practitioner.--Section
303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)(iv)) is amended by striking ``nurse practitioner or
physician assistant'' each place it appears and inserting ``nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, certified nurse midwife, or physician assistant''.
(e) Report by Secretary.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human Services,
in consultation with the Drug Enforcement Administration, shall submit
to Congress a report that assesses the care provided by qualifying
practitioners (as defined in section 303(g)(2)(G)(iii) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are
treating, in the case of physicians, more than 100 patients, and in the
case of qualifying practitioners who are not physicians, more than 30
patients. Such report shall include recommendations on future
applicable patient number levels and limits. In preparing such report,
the Secretary shall study, with respect to opioid use disorder
treatment--
(1) the average frequency with which qualifying practitioners
see their patients;
(2) the average frequency with which patients receive
counseling, including the rates by which such counseling is
provided by such a qualifying practitioner directly, or by
referral;
(3) the frequency of toxicology testing, including the average
frequency with which random toxicology testing is administered;
(4) the average monthly patient caseload for each type of
qualifying practitioner;
(5) the treatment retention rates for patients;
(6) overdose and mortality rates; and
(7) any available information regarding the diversion of drugs
by patients receiving such treatment from such a qualifying
practitioner.
SEC. 3202. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM SUBSTANCE
USE DISORDER.
(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 8 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 of Health and Human
Services shall consider ways to ensure that an adequate number of
qualified practitioners, as defined in subparagraph (G)(ii) of section
303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), who
have a specialty in pediatrics or the treatment of children or
adolescents, are granted a waiver under such section 303(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. 3203. GRANTS TO ENHANCE ACCESS TO SUBSTANCE USE DISORDER
TREATMENT.
(a) In General.--The Secretary of Health and Human Services 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 3202(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. 3204. 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) the controlled substance is to be administered for the
purpose of maintenance or detoxification treatment under section
303(g)(2) and--
``(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 section 3204(b) of the SUPPORT for
Patients and Communities Act 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.''.
CHAPTER 2--EMPOWERING PHARMACISTS IN THE FIGHT AGAINST OPIOID ABUSE
SEC. 3211. SHORT TITLE.
This chapter may be cited as the ``Empowering Pharmacists in the
Fight Against Opioid Abuse Act''.
SEC. 3212. PROGRAMS AND MATERIALS FOR TRAINING ON CERTAIN CIRCUMSTANCES
UNDER WHICH A PHARMACIST MAY DECLINE TO FILL A PRESCRIPTION.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, in
consultation with the Administrator of the Drug Enforcement
Administration, Commissioner of Food and Drugs, Director of the Centers
for Disease Control and Prevention, and Assistant Secretary for Mental
Health and Substance Use, shall develop and disseminate, as
appropriate, materials for pharmacists, health care providers, and
patients on--
(1) circumstances under which a pharmacist may, consistent with
section 309 of the Controlled Substances Act (21 U.S.C. 829) and
regulations thereunder, including section 1306.04 of title 21, Code
of Federal Regulations, decline to fill a prescription for a
controlled substance because the pharmacist suspects the
prescription is fraudulent, forged, or of doubtful, questionable,
or suspicious origin; and
(2) other Federal requirements pertaining to declining to fill
a prescription under such circumstances, including the partial fill
of prescriptions for certain controlled substances.
(b) Materials Included.--In developing materials under subsection
(a), the Secretary of Health and Human Services shall include
information for--
(1) pharmacists on how to decline to fill a prescription and
actions to take after declining to fill a prescription; and
(2) other health care practitioners and the public on a
pharmacist's ability to decline to fill prescriptions in certain
circumstances and a description of those circumstances (as
described in the materials developed under subsection (a)(1)).
(c) Stakeholder Input.--In developing the programs and materials
required under subsection (a), the Secretary of Health and Human
Services shall seek input from relevant national, State, and local
associations, boards of pharmacy, medical societies, licensing boards,
health care practitioners, and patients, including individuals with
chronic pain.
CHAPTER 3--SAFE DISPOSAL OF UNUSED MEDICATION
SEC. 3221. SHORT TITLE.
This chapter may be cited as the ``Safe Disposal of Unused
Medication Act''.
SEC. 3222. DISPOSAL OF CONTROLLED SUBSTANCES OF A HOSPICE PATIENT BY
EMPLOYEES OF A QUALIFIED HOSPICE PROGRAM.
(a) In General.--Subsection (g) of section 302 of the Controlled
Substances Act (21 U.S.C. 822) is amended by adding at the end the
following:
``(5)(A) In the case of a person receiving hospice care, an
employee of a qualified hospice program, acting within the scope of
employment, may handle, without being registered under this section,
any controlled substance that was lawfully dispensed to the person
receiving hospice care, for the purpose of disposal of the controlled
substance so long as such disposal occurs onsite in accordance with all
applicable Federal, State, Tribal, and local law and--
``(i) the disposal occurs after the death of a person receiving
hospice care;
``(ii) the controlled substance is expired; or
``(iii)(I) the employee is--
``(aa) the physician of the person receiving hospice
care; 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) For the purposes of this paragraph:
``(i) The terms `hospice care' and `hospice program' have the
meanings given to those terms in section 1861(dd) of the Social
Security Act.
``(ii) The term `employee of a qualified hospice program' means
a physician, physician assistant, nurse, or other person who--
``(I) is employed by, or pursuant to arrangements made by,
a qualified hospice program;
``(II)(aa) is licensed to perform medical or nursing
services by the jurisdiction in which the person receiving
hospice care was located; and
``(bb) is acting within the scope of such employment in
accordance with applicable State law; and
``(III) has completed training through the qualified
hospice program regarding the disposal of controlled substances
in a secure and responsible manner so as to discourage abuse,
misuse, or diversion.
``(iii) The term `qualified hospice program' means a hospice
program that--
``(I) has written policies and procedures for assisting in
the disposal of the controlled substances of a person receiving
hospice care after the person's death;
``(II) at the time when the controlled substances are first
ordered--
``(aa) provides a copy of the written policies and
procedures to the patient or patient representative and
family;
``(bb) discusses the policies and procedures with the
patient or representative and the family in a language and
manner that they understand to ensure that these parties
are educated regarding the safe disposal of controlled
substances; and
``(cc) documents in the patient's clinical record that
the written policies and procedures were provided and
discussed; and
``(III) at the time following the disposal of the
controlled substances--
``(aa) documents in the patient's clinical record the
type of controlled substance, dosage, route of
administration, and quantity so disposed; and
``(bb) the time, date, and manner in which that
disposal occurred.''.
(b) Guidance.--The Attorney General may issue guidance to hospice
programs (as defined in paragraph (5) of section 302(g) of the
Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection
(a)) to assist the programs in satisfying the requirements under such
paragraph (5).
(c) Rule of Construction Relating to State and Local Law.--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. 3223. 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 any challenges encountered by selected
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.
CHAPTER 4--SPECIAL REGISTRATION FOR TELEMEDICINE CLARIFICATION
SEC. 3231. SHORT TITLE.
This chapter may be cited as the ``Special Registration for
Telemedicine Clarification Act of 2018''.
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REGISTRATION FOR
TELEMEDICINE.
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C.
831(h)(2)) is amended to read as follows:
``(2) Regulations.--Not later than 1 year after the date of
enactment of the SUPPORT for Patients and Communities Act, in
consultation with the Secretary, the Attorney General shall
promulgate final regulations specifying--
``(A) the limited circumstances in which a special
registration under this subsection may be issued; and
``(B) the procedure for obtaining a special registration
under this subsection.''.
CHAPTER 5--SYNTHETIC ABUSE AND LABELING OF TOXIC SUBSTANCES
SEC. 3241. 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), the
following factors may be considered, along with any other relevant
factors:
``(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.
``(6) Any controlled substance analogue that is manufactured,
formulated, sold, distributed, or marketed with the intent to avoid
the provisions of existing drug laws.
``(c) Limitation.--For purposes of this section, evidence that a
substance was not marketed, advertised, or labeled for human
consumption, by itself, shall not be sufficient to establish that the
substance was not intended for human consumption.''.
CHAPTER 6--ACCESS TO INCREASED DRUG DISPOSAL
SEC. 3251. SHORT TITLE.
This chapter may be cited as the ``Access to Increased Drug
Disposal Act of 2018''.
SEC. 3252. DEFINITIONS.
In this chapter--
(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. 3253. 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. 3254. 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. 3255. 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. 3256. 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. 3257. DURATION OF GRANTS.
The Attorney General shall determine the period of years for which
a covered grant is made to a State.
SEC. 3258. 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. 3259. 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. 3260. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to the Attorney General such
sums as may be necessary to carry out this chapter.
CHAPTER 7--USING DATA TO PREVENT OPIOID DIVERSION
SEC. 3271. SHORT TITLE.
This chapter may be cited as the ``Using Data To Prevent Opioid
Diversion Act of 2018''.
SEC. 3272. PURPOSE.
(a) In General.--The purpose of this chapter 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 chapter 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. 3273. 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 30th 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 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 civil
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. 3274. 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.
CHAPTER 8--OPIOID QUOTA REFORM
SEC. 3281. SHORT TITLE.
This chapter may be cited as the ``Opioid Quota Reform Act''.
SEC. 3282. 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, in consultation with the Secretary
of Health and Human Services, 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 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''.
CHAPTER 9--PREVENTING DRUG DIVERSION
SEC. 3291. SHORT TITLE.
This chapter may be cited as the ``Preventing Drug Diversion Act of
2018''.
SEC. 3292. 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' may include, but is not
limited to--
``(A) an order of a controlled substance of unusual size;
``(B) an order of a controlled substance deviating
substantially from a normal pattern; and
``(C) orders of controlled substances of unusual
frequency.''.
(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 chapter.
(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.
TITLE IV--OFFSETS
SEC. 4001. PROMOTING VALUE IN MEDICAID MANAGED CARE.
Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as
amended by sections 1013 and 1016, is further amended by adding at the
end the following new paragraph:
``(9)(A) With respect to expenditures described in subparagraph (B)
that are incurred by a State for any fiscal year after fiscal year 2020
(and before fiscal year 2024), in determining the pro rata share to
which the United States is equitably entitled under subsection (d)(3),
the Secretary shall substitute the Federal medical assistance
percentage that applies for such fiscal year to the State under section
1905(b) (without regard to any adjustments to such percentage
applicable under such section or any other provision of law) for the
percentage that applies to such expenditures under section 1905(y).
``(B) Expenditures described in this subparagraph, with respect to
a fiscal year to which subparagraph (A) applies, are expenditures
incurred by a State for payment for medical assistance provided to
individuals described in subclause (VIII) of section 1902(a)(10)(A)(i)
by a managed care entity, or other specified entity (as defined in
subparagraph (D)(iii)), that are treated as remittances because the
State--
``(i) has satisfied the requirement of section 438.8 of title
42, Code of Federal Regulations (or any successor regulation), by
electing--
``(I) in the case of a State described in subparagraph (C),
to apply a minimum medical loss ratio (as defined in
subparagraph (D)(ii)) that is at least 85 percent but not
greater than the minimum medical loss ratio (as so defined)
that such State applied as of May 31, 2018; or
``(II) in the case of a State not described in subparagraph
(C), to apply a minimum medical loss ratio that is equal to 85
percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described in this
subparagraph is a State that as of May 31, 2018, applied a minimum
medical loss ratio (as calculated under subsection (d) of section 438.8
of title 42, Code of Federal Regulations (as in effect on June 1,
2018)) for payment for services provided by entities described in such
subparagraph under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid managed
care organization described in section 1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as calculated
under subsection (d) of section 438.8 of title 42, Code of Federal
Regulations (as in effect on June 1, 2018)) for payment for
services provided by entities described in subparagraph (B) under
the State plan under this title (or a waiver of the plan).
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined in
section 438.2 of title 42, Code of Federal Regulations (or any
successor regulation); and
``(II) a prepaid ambulatory health plan, as defined in such
section (or any successor regulation).''.
SEC. 4002. REQUIRING REPORTING BY GROUP HEALTH PLANS OF PRESCRIPTION
DRUG COVERAGE INFORMATION FOR PURPOSES OF IDENTIFYING PRIMARY PAYER
SITUATIONS UNDER THE MEDICARE PROGRAM.
Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42
U.S.C. 1395y(b)(7)(A)) is amended to read as follows:
``(i) secure from the plan sponsor and plan
participants such information as the Secretary shall
specify for the purpose of identifying situations where the
group health plan is or has been--
``(I) a primary plan to the program under this
title; or
``(II) for calendar quarters beginning on or after
January 1, 2020, a primary payer with respect to
benefits relating to prescription drug coverage under
part D; and''.
SEC. 4003. ADDITIONAL RELIGIOUS EXEMPTION FROM HEALTH COVERAGE
RESPONSIBILITY REQUIREMENT.
(a) In General.--Section 5000A(d)(2)(A) of the Internal Revenue
Code of 1986 is amended to read as follows:
``(A) Religious conscience exemptions.--
``(i) In general.--Such term shall not include any
individual for any month if such individual has in effect
an exemption under section 1311(d)(4)(H) of the Patient
Protection and Affordable Care Act which certifies that--
``(I) such individual is a member of a recognized
religious sect or division thereof which is described
in section 1402(g)(1), and is adherent of established
tenets or teachings of such sect or division as
described in such section; or
``(II) such individual is a member of a religious
sect or division thereof which is not described in
section 1402(g)(1), who relies solely on a religious
method of healing, and for whom the acceptance of
medical health services would be inconsistent with the
religious beliefs of the individual.
``(ii) Special rules.--
``(I) Medical health services defined.--For
purposes of this subparagraph, the term `medical health
services' does not include routine dental, vision and
hearing services, midwifery services, vaccinations,
necessary medical services provided to children,
services required by law or by a third party, and such
other services as the Secretary of Health and Human
Services may provide in implementing section
1311(d)(4)(H) of the Patient Protection and Affordable
Care Act.
``(II) Attestation required.--Clause (i)(II) shall
apply to an individual for months in a taxable year
only if the information provided by the individual
under section 1411(b)(5)(A) of such Act includes an
attestation that the individual has not received
medical health services during the preceding taxable
year.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to taxable years beginning after December 31, 2018.
(c) Construction.--Nothing in the amendment made by subsection (a)
shall preempt any State law requiring the provision of medical
treatment for children, especially those who are seriously ill.
SEC. 4004. MODERNIZING THE REPORTING OF BIOLOGICAL AND BIOSIMILAR
PRODUCTS.
Subtitle B of title XI of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-173) is
amended--
(1) in section 1111, as amended by section 3(1) of the Patient
Right to Know Drug Prices Act--
(A) in the paragraph (3) inserted by such section 3(1), by
striking ``an application'' and inserting ``a biosimilar
biological product application'';
(B) in the paragraph (4) inserted by such section 3(1), by
inserting ``application'' before ``under section 351(k) of the
Public Health Service Act'';
(C) in the paragraph (5) inserted by such section 3(1), by
striking ``for licensure of a biological product under section
351(k) of the Public Health Service Act'' and inserting ``under
section 351(k) of the Public Health Service Act for licensure
of a biological product as biosimilar to, or interchangeable
with, a reference product'';
(D) in paragraph (7), as redesignated and amended by such
section 3(1), by striking ``or under section 351(a) of the
Public Health Service Act'' and inserting ``or the owner, or
exclusive licensee, of a patent included in a list provided
under section 351(l)(3) of the Public Health Service Act''; and
(E) in the paragraph (12) added by such section 3(1), by
striking ``means a brand name drug for which a license is in
effect under section 351(a)'' and inserting ``has the meaning
given such term in section 351(i)''; and
(2) in section 1112, as amended by section 3(2) of the Patient
Right to Know Drug Prices Act--
(A) in subsection (a)--
(i) in paragraph (1), by striking ``for which a
statement under section 351(l)(3)(B)(ii)(I) of the Public
Health Service Act has been provided'';
(ii) in paragraph (2)--
(I) in subparagraph (C)(i), by striking ``brand
name'' and inserting ``listed''; and
(II) by amending clause (ii) of subparagraph (C) to
read as follows:
``(ii) any of the time periods referred to in section
351(k)(6) of the Public Health Service Act as such period
applies to such biosimilar biological product application
or to any other biosimilar biological product application
based on the same reference product.'';
(B) in subsection (b)--
(i) in the subsection heading, by inserting ``or
Biosimilar Biological Product Applicant'' after
``Applicant'';
(ii) in paragraph (1)(B), by striking the first
sentence and inserting the following: ``A biosimilar
biological product applicant that has submitted a
biosimilar biological product application that references a
reference product and another biosimilar biological product
applicant that has submitted a biosimilar biological
product application that references the same reference
product shall each file the agreement in accordance with
subsection (c).''; and
(iii) in paragraph (2)--
(I) by striking ``2 generic drug applicants'' and
inserting ``2 or more generic drug applicants''; and
(II) by striking ``or an agreement between 2
biosimilar biological product applicants regarding the
1-year period referred to in section 351(k)(6)(A) of
the Public Health Service Act as it applies to the
biosimilar biological product applications with which
the agreement is concerned'' and inserting ``, an
agreement between 2 or more biosimilar biological
product applicants regarding a time period referred to
in section 351(k)(6) of the Public Health Service Act
as it applies to the biosimilar biological product, or
an agreement between 2 or more biosimilar biological
product applicants regarding the manufacture,
marketing, or sale of a biosimilar biological
product''; and
(C) in subsection (c)(2), by inserting ``were entered into
within 30 days of,'' after ``condition for,''.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
SEC. 5001. 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.''; and
(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))''.
Subtitle B--Medicaid IMD Additional Info
SEC. 5011. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Institutes for Mental
Disease Are Decisive in Delivering Inpatient Treatment for Individuals
but Opportunities for Needed Access are Limited without Information
Needed about Facility Obligations Act'' or the ``Medicaid IMD
ADDITIONAL INFO Act''.
SEC. 5012. MACPAC EXPLORATORY STUDY AND REPORT ON INSTITUTIONS FOR
MENTAL DISEASES REQUIREMENTS AND PRACTICES UNDER MEDICAID.
(a) In General.--Not later than January 1, 2020, the Medicaid and
CHIP Payment and Access Commission established under section 1900 of
the Social Security Act (42 U.S.C. 1396) shall conduct an exploratory
study, using data from a representative sample of States, and submit to
Congress a report on at least the following information, with respect
to services furnished to individuals enrolled under State plans under
the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et
seq.) (or waivers of such plans) who are patients in institutions for
mental diseases and for which payment is made through fee-for-service
or managed care arrangements under such State plans (or waivers):
(1) A description of such institutions for mental diseases in
each such State, including at a minimum--
(A) the number of such institutions in the State;
(B) the facility type of such institutions in the State;
and
(C) any coverage limitations under each such State plan (or
waiver) on scope, duration, or frequency of such services.
(2) With respect to each such institution for mental diseases
in each such State, a description of--
(A) such services provided at such institution;
(B) the process, including any timeframe, used by such
institution to clinically assess and reassess such individuals;
and
(C) the discharge process used by such institution,
including any care continuum of relevant services or facilities
provided or used in such process.
(3) A description of--
(A) any Federal waiver that each such State has for such
institutions and the Federal statutory authority for such
waiver; and
(B) any other Medicaid funding sources used by each such
State for funding such institutions, such as supplemental
payments.
(4) A summary of State requirements (such as certification,
licensure, and accreditation) applied by each such State to such
institutions in order for such institutions to receive payment
under the State plan (or waiver) and how each such State determines
if such requirements have been met.
(5) A summary of State standards (such as quality standards,
clinical standards, and facility standards) that such institutions
must meet to receive payment under such State plans (or waivers)
and how each such State determines if such standards have been met.
(6) If determined appropriate by the Commission,
recommendations for policies and actions by Congress and the
Centers for Medicare & Medicaid Services, such as on how State
Medicaid programs may improve care and improve standards and
including a recommendation for how the Centers for Medicare &
Medicaid Services can improve data collection from such programs to
address any gaps in information.
(b) Stakeholder Input.--In carrying out subsection (a), the
Medicaid and CHIP Payment and Access Commission shall seek input from
State Medicaid directors and stakeholders, including at a minimum the
Substance Abuse and Mental Health Services Administration, Centers for
Medicare & Medicaid Services, State Medicaid officials, State mental
health authorities, Medicaid beneficiary advocates, health care
providers, and Medicaid managed care organizations.
(c) Definitions.--In this section:
(1) Representative sample of states.--The term ``representative
sample of States'' means a non-probability sample in which at least
two States are selected based on the knowledge and professional
judgment of the selector.
(2) State.--The term ``State'' means each of the 50 States, the
District of Columbia, and any commonwealth or territory of the
United States.
(3) Institution for mental diseases.--The term ``institution
for mental diseases'' has the meaning given such term in section
435.1010 of title 42, Code of Federal Regulations, or any successor
regulation.
Subtitle C--CHIP Mental Health and Substance Use Disorder Parity
SEC. 5021. SHORT TITLE.
This subtitle may be cited as the ``CHIP Mental Health and
Substance Use Disorder Parity Act''.
SEC. 5022. ENSURING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER
SERVICES FOR CHILDREN AND PREGNANT WOMEN UNDER THE CHILDREN'S HEALTH
INSURANCE PROGRAM.
(a) In General.--Section 2103(c)(1) of the Social Security Act (42
U.S.C. 1397cc(c)(1)) is amended by adding at the end the following new
subparagraph:
``(E) Mental health and substance use disorder services (as
defined in paragraph (5)).''.
(b) Mental Health and Substance Use Disorder Services.--
(1) In general.--Section 2103(c) of the Social Security Act (42
U.S.C. 1397cc(c)) is amended--
(A) by redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (6), (7), (8), and (9), respectively; and
(B) by inserting after paragraph (4) the following new
paragraph:
``(5) Mental health and substance use disorder services.--
Regardless of the type of coverage elected by a State under
subsection (a), child health assistance provided under such
coverage for targeted low-income children and, in the case that the
State elects to provide pregnancy-related assistance under such
coverage pursuant to section 2112, such pregnancy-related
assistance for targeted low-income pregnant women (as defined in
section 2112(d)) shall--
``(A) include coverage of mental health services (including
behavioral health treatment) necessary to prevent, diagnose,
and treat a broad range of mental health symptoms and
disorders, including substance use disorders; and
``(B) be delivered in a culturally and linguistically
appropriate manner.''.
(2) Conforming amendments.--
(A) Section 2103(a) of the Social Security Act (42 U.S.C.
1397cc(a)) is amended, in the matter before paragraph (1), by
striking ``paragraphs (5), (6), and (7)'' and inserting
``paragraphs (5), (6), (7), and (8)''.
(B) Section 2110(a) of the Social Security Act (42 U.S.C.
1397jj(a)) is amended--
(i) in paragraph (18), by striking ``substance abuse''
each place it appears and inserting ``substance use''; and
(ii) in paragraph (19), by striking ``substance abuse''
and inserting ``substance use''.
(C) Section 2110(b)(5)(A)(i) of the Social Security Act (42
U.S.C. 1397jj(b)(5)(A)(i)) is amended by striking ``subsection
(c)(5)'' and inserting ``subsection (c)(6)''.
(c) Assuring Access to Care.--Section 2102(a)(7)(B) of the Social
Security Act (42 U.S.C. 1397bb(c)(2)) is amended by striking ``section
2103(c)(5)'' and inserting ``paragraphs (5) and (6) of section
2103(c)''.
(d) Mental Health Services Parity.--Subparagraph (A) of paragraph
(7) of section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c))
(as redesignated by subsection (b)(1)) is amended to read as follows:
``(A) In general.--A State child health plan shall ensure
that the financial requirements and treatment limitations
applicable to mental health and substance use disorder services
(as described in paragraph (5)) provided under such plan comply
with the requirements of section 2726(a) of the Public Health
Service Act in the same manner as such requirements or
limitations apply to a group health plan under such section.''.
(e) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments made
by this section shall take effect with respect to child health
assistance provided on or after the date that is 1 year after the
date of the enactment of this Act.
(2) Exception for state legislation.--In the case of a State
child health plan under title XXI of the Social Security Act (or a
waiver of such plan), which the Secretary of Health and Human
Services determines requires State legislation in order for the
respective plan (or waiver) to meet any requirement imposed by the
amendments made by this section, the respective plan (or waiver)
shall not be regarded as failing to comply with the requirements of
such title solely on the basis of its failure to meet such an
additional requirement 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 enactment of
this section. For purposes of the previous sentence, in the case of
a State that has a 2-year legislative session, each year of the
session shall be considered to be a separate regular session of the
State legislature.
Subtitle D--Medicaid Reentry
SEC. 5031. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Reentry Act''.
SEC. 5032. PROMOTING STATE INNOVATIONS TO EASE TRANSITIONS INTEGRATION
TO THE COMMUNITY FOR CERTAIN INDIVIDUALS.
(a) Stakeholder Group Development of Best Practices; State Medicaid
Program Innovation.--
(1) Stakeholder group best practices.--Not later than 6 months
after the date of the enactment of this Act, the Secretary of
Health and Human Services shall convene a stakeholder group of
representatives of managed care organizations, Medicaid
beneficiaries, health care providers, the National Association of
Medicaid Directors, and other relevant representatives from local,
State, and Federal jail and prison systems to develop best
practices (and submit to the Secretary and Congress a report on
such best practices) for States--
(A) to ease the health care-related transition of an
individual who is an inmate of a public institution from the
public institution to the community, including best practices
for ensuring continuity of health insurance coverage or
coverage under the State Medicaid plan under title XIX of the
Social Security Act, as applicable, and relevant social
services; and
(B) to carry out, with respect to such an individual, such
health care-related transition not later than 30 days after
such individual is released from the public institution.
(2) State medicaid program innovation.--The Secretary of Health
and Human Services shall work with States on innovative strategies
to help individuals who are inmates of public institutions and
otherwise eligible for medical assistance under the Medicaid
program under title XIX of the Social Security Act transition, with
respect to enrollment for medical assistance under such program,
seamlessly to the community.
(b) Guidance on Innovative Service Delivery Systems Demonstration
Project Opportunities.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services,
through the Administrator of the Centers for Medicare & Medicaid
Services, shall issue a State Medicaid Director letter, based on best
practices developed under subsection (a)(1), regarding opportunities to
design demonstration projects under section 1115 of the Social Security
Act (42 U.S.C. 1315) to improve care transitions for certain
individuals who are soon-to-be former inmates of a public institution
and who are otherwise eligible to receive medical assistance under
title XIX of such Act, including systems for, with respect to a period
(not to exceed 30 days) immediately prior to the day on which such
individuals are expected to be released from such institution--
(1) providing assistance and education for enrollment under a
State plan under the Medicaid program under title XIX of such Act
for such individuals during such period; and
(2) providing health care services for such individuals during
such period.
(c) Rule of Construction.--Nothing under title XIX of the Social
Security Act or any other provision of law precludes a State from
reclassifying or suspending (rather than terminating) eligibility of an
individual for medical assistance under title XIX of the Social
Security Act while such individual is an inmate of a public
institution.
Subtitle E--Medicaid Partnership
SEC. 5041. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Providers Are Required
To Note Experiences in Record Systems to Help In-need Patients Act'' or
the ``Medicaid PARTNERSHIP Act''.
SEC. 5042. MEDICAID PROVIDERS ARE REQUIRED TO NOTE EXPERIENCES IN
RECORD SYSTEMS TO HELP IN-NEED PATIENTS.
(a) Requirements Under the Medicaid Program Relating to Qualified
Prescription Drug Monitoring Programs and Prescribing Certain
Controlled Substances.--Title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) is amended by inserting after section 1943 the following
new section:
``SEC. 1944. REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION DRUG
MONITORING PROGRAMS AND PRESCRIBING CERTAIN CONTROLLED SUBSTANCES.
``(a) In General.--Subject to subsection (d), beginning October 1,
2021, a State--
``(1) shall require each covered provider to check, in
accordance with such timing, manner, and form as specified by the
State, the prescription drug history of a covered individual being
treated by the covered provider through a qualified prescription
drug monitoring program described in subsection (b) before
prescribing to such individual a controlled substance; and
``(2) in the case that such a provider is not able to conduct
such a check despite a good faith effort by such provider--
``(A) shall require the provider to document such good
faith effort, including the reasons why the provider was not
able to conduct the check; and
``(B) may require the provider to submit, upon request,
such documentation to the State.
``(b) Qualified Prescription Drug Monitoring Program Described.--A
qualified prescription drug monitoring program described in this
subsection is, with respect to a State, a prescription drug monitoring
program administered by the State that, at a minimum, satisfies each of
the following criteria:
``(1) The program facilitates access by a covered provider to,
at a minimum, the following information with respect to a covered
individual, in as close to real-time as possible:
``(A) Information regarding the prescription drug history
of a covered individual with respect to controlled substances.
``(B) The number and type of controlled substances
prescribed to and filled for the covered individual during at
least the most recent 12-month period.
``(C) The name, location, and contact information (or other
identifying number selected by the State, such as a national
provider identifier issued by the National Plan and Provider
Enumeration System of the Centers for Medicare & Medicaid
Services) of each covered provider who prescribed a controlled
substance to the covered individual during at least the most
recent 12-month period.
``(2) The program facilitates the integration of information
described in paragraph (1) into the workflow of a covered provider,
which may include the electronic system the covered provider uses
to prescribe controlled substances.
A qualified prescription drug monitoring program described in this
subsection, with respect to a State, may have in place, in accordance
with applicable State and Federal law, a data-sharing agreement with
the State Medicaid program that allows the medical director and
pharmacy director of such program (and any designee of such a director
who reports directly to such director) to access the information
described in paragraph (1) in an electronic format. The State Medicaid
program under this title may facilitate reasonable and limited access,
as determined by the State and ensuring documented beneficiary
protections regarding the use of such data, to such qualified
prescription drug monitoring program for the medical director or
pharmacy director of any managed care entity (as defined under section
1932(a)(1)(B)) that has a contract with the State under section 1903(m)
or under section 1905(t)(3), or the medical director or pharmacy
director of any entity that has a contract to manage the pharmaceutical
benefit with respect to individuals enrolled in the State plan (or
under a waiver of the State plan). All applicable State and Federal
security and privacy laws shall apply to the directors or designees of
such directors of any State Medicaid program or entity accessing a
qualified prescription drug monitoring program under this section.
``(c) Application of Privacy Rules Clarification.--The Secretary
shall clarify privacy requirements, including requirements under the
regulations promulgated pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note), related to the sharing of data under subsection (b) in the same
manner as the Secretary is required under subparagraph (J) of section
1860D-4(c)(5) to clarify privacy requirements related to the sharing of
data described in such subparagraph.
``(d) Ensuring Access.--In order to ensure reasonable access to
health care, the Secretary shall waive the application of the
requirement under subsection (a), with respect to a State, in the case
of natural disasters and similar situations, and in the case of the
provision of emergency services (as defined for purposes of section
1860D-4(c)(5)(D)(ii)(II)).
``(e) Reports.--
``(1) State reports.--Each State shall include in the annual
report submitted to the Secretary under section 1927(g)(3)(D),
beginning with such reports submitted for 2023, information
including, at a minimum, the following information for the most
recent 12-month period:
``(A) The percentage of covered providers (as determined
pursuant to a process established by the State) who checked the
prescription drug history of a covered individual through a
qualified prescription drug monitoring program described in
subsection (b) before prescribing to such individual a
controlled substance.
``(B) Aggregate trends with respect to prescribing
controlled substances such as--
``(i) the quantity of daily morphine milligram
equivalents prescribed for controlled substances;
``(ii) the number and quantity of daily morphine
milligram equivalents prescribed for controlled substances
per covered individual; and
``(iii) the types of controlled substances prescribed,
including the dates of such prescriptions, the supplies
authorized (including the duration of such supplies), and
the period of validity of such prescriptions, in different
populations (such as individuals who are elderly,
individuals with disabilities, and individuals who are
enrolled under both this title and title XVIII).
``(C) Whether or not the State requires (and a detailed
explanation as to why the State does or does not require)
pharmacists to check the prescription drug history of a covered
individual through a qualified prescription drug monitoring
program described in subsection (b) before dispensing a
controlled substance to such individual.
``(D) An accounting of any data or privacy breach of a
qualified prescription drug monitoring program described in
subsection (b), the number of covered individuals impacted by
each such breach, and a description of the steps the State has
taken to address each such breach, including, to the extent
required by State or Federal law or otherwise determined
appropriate by the State, alerting any such impacted individual
and law enforcement of the breach.
``(2) Report by cms.--Not later than October 1, 2023, the
Administrator of the Centers for Medicare & Medicaid Services shall
publish on the publicly available website of the Centers for
Medicare & Medicaid Services a report including the following
information:
``(A) Guidance for States on how States can increase the
percentage of covered providers who use qualified prescription
drug monitoring programs described in subsection (b).
``(B) Best practices for how States and covered providers
should use such qualified prescription drug monitoring programs
to reduce the occurrence of abuse of controlled substances.
``(f) Increase to FMAP and Federal Matching Rates for Certain
Expenditures Relating to Qualified Prescription Drug Monitoring
Programs.--
``(1) In general.--With respect to a State that meets the
condition described in paragraph (2) and any quarter occurring
during fiscal year 2019 or fiscal year 2020, the Federal medical
assistance percentage or Federal matching rate that would otherwise
apply to such State under section 1903(a) for such quarter, with
respect to expenditures by the State for activities under the State
plan (or a waiver of such plan) to design, develop, or implement a
prescription drug monitoring program (and to make connections to
such program) that satisfies the criteria described in paragraphs
(1) and (2) of subsection (b), shall be equal to 100 percent.
``(2) Condition.--The condition described in this paragraph,
with respect to a State, is that the State (in this paragraph
referred to as the `administering State') has in place agreements
with all States that are contiguous to such administering State
that, when combined, enable covered providers in all such
contiguous States to access, through the prescription drug
monitoring program, the information that is described in subsection
(b)(1) of covered individuals of such administering State and that
covered providers in such administering State are able to access
through such program.
``(g) Rule of Construction.--Nothing in this section prevents a
State from requiring pharmacists to check the prescription drug history
of covered individuals through a qualified prescription drug monitoring
program before dispensing controlled substances to such individuals.
``(h) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled substance'
means a drug that is included in schedule II of section 202(c) of
the Controlled Substances Act and, at the option of the State
involved, a drug included in schedule III or IV of such section.
``(2) Covered individual.--The term `covered individual' means,
with respect to a State, an individual who is enrolled in the State
plan (or under a waiver of such plan). Such term does not include
an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility, of a
facility described in section 1905(d), or of another facility
for which frequently abused drugs are dispensed for residents
through a contract with a single pharmacy; or
``(C) the State elects to treat as exempted from such term.
``(3) Covered provider.--
``(A) In general.--The term `covered provider' means,
subject to subparagraph (B), with respect to a State, a health
care provider who is participating under the State plan (or
waiver of the State plan) and licensed, registered, or
otherwise permitted by the State to prescribe a controlled
substance (or the designee of such provider).
``(B) Exceptions.--
``(i) In general.--Beginning October 1, 2021, for
purposes of this section, such term does not include a
health care provider included in any type of health care
provider determined by the Secretary to be exempt from
application of this section under clause (ii).
``(ii) Exceptions process.--Not later than October 1,
2020, the Secretary, after consultation with the National
Association of Medicaid Directors, national health care
provider associations, Medicaid beneficiary advocates, and
advocates for individuals with rare diseases, shall
determine, based on such consultations, the types of health
care providers (if any) that should be exempted from the
definition of the term `covered provider' for purposes of
this section.''.
(b) Guidance.--Not later than October 1, 2019, the Administrator of
the Centers for Medicare & Medicaid Services, in consultation with the
Director of the Centers for Disease Control and Prevention, shall issue
guidance on best practices on the uses of prescription drug monitoring
programs required of prescribers and on protecting the privacy of
Medicaid beneficiary information maintained in and accessed through
prescription drug monitoring programs.
(c) Development of Model State Practices.--
(1) In general.--Not later than October 1, 2020, the Secretary
of Health and Human Services shall develop and publish model
practices to assist State Medicaid program operations in
identifying and implementing strategies to utilize data-sharing
agreements described in the matter following paragraph (2) of
section 1944(b) of the Social Security Act, as added by subsection
(a), for the following purposes:
(A) Monitoring and preventing fraud, waste, and abuse.
(B) Improving health care for individuals enrolled in a
State plan under title XIX of such Act (or under a waiver of
such plan) who--
(i) transition in and out of coverage under such title;
(ii) may have sources of health care coverage in
addition to coverage under such title; or
(iii) pay for prescription drugs with cash.
(C) Any other purposes specified by the Secretary.
(2) Elements of model practices.--The model practices described
in paragraph (1)--
(A) shall include strategies for assisting States in
allowing the medical director or pharmacy director (or
designees of such a director) of managed care organizations or
pharmaceutical benefit managers to access information with
respect to all covered individuals served by such managed care
organizations or pharmaceutical benefit managers to access as a
single data set, in an electronic format; and
(B) shall include any appropriate beneficiary protections
and privacy guidelines.
(3) Consultation.--In developing model practices under this
subsection, the Secretary shall consult with the National
Association of Medicaid Directors, managed care entities (as
defined in section 1932(a)(1)(B) of the Social Security Act) with
contracts with States pursuant to section 1903(m) of such Act,
pharmaceutical benefit managers, physicians and other health care
providers, beneficiary advocates, and individuals with expertise in
health care technology related to prescription drug monitoring
programs and electronic health records.
(d) Report by Comptroller General.--Not later than October 1, 2020,
the Comptroller General of the United States shall issue a report
examining the operation of prescription drug monitoring programs
administered by States, including data security and access standards
used by such programs.
Subtitle F--IMD CARE Act
SEC. 5051. SHORT TITLE.
This title may be cited as the ``Individuals in Medicaid Deserve
Care that is Appropriate and Responsible in its Execution Act'' or the
``IMD CARE Act''.
SEC. 5052. STATE OPTION TO PROVIDE MEDICAID COVERAGE FOR CERTAIN
INDIVIDUALS WITH SUBSTANCE USE DISORDERS WHO ARE PATIENTS IN CERTAIN
INSTITUTIONS FOR MENTAL DISEASES.
(a) In General.--Title XIX of the Social Security Act (42 U.S.C.
1396 et seq.), as amended by preceding sections of this Act, is further
amended--
(1) in section 1905(a), in the subdivision (B) that follows
paragraph (30), by inserting ``(except in the case of services
provided under a State plan amendment described in section
1915(l))'' before the period; and
(2) in section 1915, by adding at the end the following new
subsection:
``(l) State Plan Amendment Option to Provide Medical Assistance for
Certain Individuals Who Are Patients in Certain Institutions for Mental
Diseases.--
``(1) In general.--With respect to calendar quarters beginning
during the period beginning October 1, 2019, and ending September
30, 2023, a State may elect, through a State plan amendment, to
provide medical assistance for items and services furnished to an
eligible individual who is a patient in an eligible institution for
mental diseases in accordance with the requirements of this
subsection.
``(2) Payments.--Subject to paragraphs (3) and (4), amounts
expended under a State plan amendment under paragraph (1) for
services described in such paragraph furnished, with respect to a
12-month period, to an eligible individual who is a patient in an
eligible institution for mental diseases shall be treated as
medical assistance for which payment is made under section 1903(a)
but only to the extent that such services are furnished for not
more than a period of 30 days (whether or not consecutive) during
such 12-month period.
``(3) Maintenance of effort.--
``(A) In general.--As a condition for a State receiving
payments under section 1903(a) for medical assistance provided
in accordance with this subsection, the State shall (during the
period in which it so furnished such medical assistance through
a State plan amendment under this subsection) maintain on an
annual basis a level of funding expended by the State (and
political subdivisions thereof) other than under this title
from non-Federal funds for--
``(i) items and services furnished to eligible
individuals who are patients in eligible institutions for
mental diseases that is not less than the level of such
funding for such items and services for the most recently
ended fiscal year as of the date of enactment of this
subsection or, if higher, for the most recently ended
fiscal year as of the date the State submits a State plan
amendment to the Secretary to provide such medical
assistance in accordance with this subsection; and
``(ii) items and services (including services described
in subparagraph (B)) furnished to eligible individuals in
outpatient and community-based settings that is not less
than the level of such funding for such items and services
for the most recently ended fiscal year as of the date of
enactment of this subsection or, if higher, for the most
recently ended fiscal year as of the date the State submits
a State plan amendment to the Secretary to provide such
medical assistance in accordance with this subsection.
``(B) Services described.--For purposes of subparagraph
(A)(ii), services described in this subparagraph are the
following:
``(i) Outpatient and community-based substance use
disorder treatment.
``(ii) Evidence-based recovery and support services.
``(iii) Clinically-directed therapeutic treatment to
facilitate recovery skills, relapse prevention, and
emotional coping strategies.
``(iv) Outpatient medication-assisted treatment,
related therapies, and pharmacology.
``(v) Counseling and clinical monitoring.
``(vi) Outpatient withdrawal management and related
treatment designed to alleviate acute emotional,
behavioral, cognitive, or biomedical distress resulting
from, or occurring with, an individual's use of alcohol and
other drugs.
``(vii) Routine monitoring of medication adherence.
``(viii) Other outpatient and community-based services
for the treatment of substance use disorders, as designated
by the Secretary.
``(C) State reporting requirement.--
``(i) In general.--Prior to approval of a State plan
amendment under this subsection, as a condition for a State
receiving payments under section 1903(a) for medical
assistance provided in accordance with this subsection, the
State shall report to the Secretary, in accordance with the
process established by the Secretary under clause (ii), the
information deemed necessary by the Secretary under such
clause.
``(ii) Process.--Not later than the date that is 8
months after the date of enactment of this subsection, the
Secretary shall establish a process for States to report to
the Secretary, at such time and in such manner as the
Secretary deems appropriate, such information as the
Secretary deems necessary to verify a State's compliance
with subparagraph (A).
``(4) Ensuring a continuum of services.--
``(A) In general.--As a condition for a State receiving
payments under section 1903(a) for medical assistance provided
in accordance with this subsection, the State shall carry out
each of the requirements described in subparagraphs (B) through
(D).
``(B) Notification.--Prior to approval of a State plan
amendment under this subsection, the State shall notify the
Secretary of how the State will ensure that eligible
individuals receive appropriate evidence-based clinical
screening prior to being furnished with items and services in
an eligible institution for mental diseases, including initial
and periodic assessments to determine the appropriate level of
care, length of stay, and setting for such care for each
individual.
``(C) Outpatient services; inpatient and residential
services.--
``(i) Outpatient services.--The State shall, at a
minimum, provide medical assistance for services that could
otherwise be covered under the State plan, consistent with
each of the following outpatient levels of care:
``(I) Early intervention for individuals who, for a
known reason, are at risk of developing substance-
related problems and for individuals for whom there is
not yet sufficient information to document a
diagnosable substance use disorder.
``(II) Outpatient services for less than 9 hours
per week for adults, and for less than 6 hours per week
for adolescents, for recovery or motivational
enhancement therapies and strategies.
``(III) Intensive outpatient services for 9 hours
or more per week for adults, and for 6 hours or more
per week for adolescents, to treat multidimensional
instability.
``(IV) Partial hospitalization services for 20
hours or more per week for adults and adolescents to
treat multidimensional instability that does not
require 24-hour care.
``(ii) Inpatient and residential services.--The State
shall provide medical assistance for services that could
otherwise be covered under the State plan, consistent with
at least 2 of the following inpatient and residential
levels of care:
``(I) Clinically managed, low-intensity residential
services that provide adults and adolescents with 24-
hour living support and structure with trained
personnel and at least 5 hours of clinical service per
week per individual.
``(II) Clinically managed, population-specific,
high-intensity residential services that provide adults
with 24-hour care with trained counselors to stabilize
multidimensional imminent danger along with less
intense milieu and group treatment for those with
cognitive or other impairments unable to use full
active milieu or therapeutic community.
``(III) Clinically managed, medium-intensity
residential services for adolescents, and clinically
managed, high-intensity residential services for
adults, that provide 24-hour care with trained
counselors to stabilize multidimensional imminent
danger and preparation for outpatient treatment.
``(IV) Medically monitored, high-intensity
inpatient services for adolescents, and medically
monitored, intensive inpatient services withdrawal
management for adults, that provide 24-hour nursing
care, make physicians available for significant
problems in Dimensions 1, 2, or 3, and provide
counseling services 16 hours per day.
``(V) Medically managed, intensive inpatient
services for adolescents and adults that provide 24-
hour nursing care and daily physician care for severe,
unstable problems in Dimensions 1, 2 or 3.
``(D) Transition of care.--In order to ensure an
appropriate transition for an eligible individual from
receiving care in an eligible institution for mental diseases
to receiving care at a lower level of clinical intensity within
the continuum of care (including outpatient services), the
State shall ensure that--
``(i) a placement in such eligible institution for
mental diseases would allow for an eligible individual's
successful transition to the community, considering such
factors as proximity to an individual's support network
(such as family members, employment, and counseling and
other services near an individual's residence); and
``(ii) all eligible institutions for mental diseases
that furnish items and services to individuals for which
medical assistance is provided under the State plan--
``(I) are able to provide care at such lower level
of clinical intensity; or
``(II) have an established relationship with
another facility or provider that is able to provide
care at such lower level of clinical intensity and
accepts patients receiving medical assistance under
this title under which the eligible institution for
mental diseases may arrange for individuals to receive
such care from such other facility or provider.
``(5) Application to managed care.--Payments for, and
limitations to, medical assistance furnished in accordance with
this subsection shall be in addition to and shall not be construed
to limit or supersede the ability of States to make monthly
capitation payments to managed care organizations for individuals
receiving treatment in institutions for mental diseases in
accordance with section 438.6(e) of title 42, Code of Federal
Regulations (or any successor regulation).
``(6) Other medical assistance.--The provision of medical
assistance for items and services furnished to an eligible
individual who is a patient in an eligible institution for mental
diseases in accordance with the requirements of this subsection
shall not prohibit Federal financial participation for medical
assistance for items or services that are provided to such eligible
individual in or away from the eligible institution for mental
disease during any period in which the eligible individual is
receiving items or services in accordance with this subsection.
``(7) Definitions.--In this subsection:
``(A) Dimensions 1, 2, or 3.--The term `Dimensions 1, 2, or
3' has the meaning given that term for purposes of the
publication of the American Society of Addiction Medicine
entitled `The ASAM Criteria: Treatment Criteria for Addictive
Substance-Related, and Co-Occurring Conditions, 2013'.
``(B) Eligible individual.--The term `eligible individual'
means an individual who--
``(i) with respect to a State, is enrolled for medical
assistance under the State plan or a waiver of such plan;
``(ii) is at least 21 years of age;
``(iii) has not attained 65 years of age; and
``(iv) has at least 1 substance use disorder.
``(C) Eligible institution for mental diseases.--The term
`eligible institution for mental diseases' means an institution
for mental diseases that--
``(i) follows reliable, evidence-based practices; and
``(ii) offers at least 2 forms of medication-assisted
treatment for substance use disorders on site, including,
in the case of medication-assisted treatment for opioid use
disorder, at least 1 antagonist and 1 partial agonist.
``(D) Institution for mental diseases.--The term
`institution for mental diseases' has the meaning given that
term in section 1905(i).''.
(b) Rule of Construction.--Nothing in the amendments made by
subsection (a) shall be construed as encouraging a State to place an
individual in an inpatient or a residential care setting where a home
or community-based care setting would be more appropriate for the
individual, or as preventing a State from conducting or pursuing a
demonstration project under section 1115 of the Social Security Act to
improve access to, and the quality of, substance use disorder treatment
for eligible populations.
Subtitle G--Medicaid Improvement Fund
SEC. 5061. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w-
1(b)(1)) is amended by striking ``$0'' and inserting ``$31,000,000''.
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health
Providers for Adoption and Use of Certified Electronic Health Record
Technology
SEC. 6001. 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, for the adoption and use of
certified EHR 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, incentive payments to behavioral health
providers (such as psychiatric hospitals (as defined in
section 1861(f)), community mental health centers (as
defined in section 1861(ff)(3)(B)), hospitals that
participate in a State plan under title XIX or a waiver of
such plan, treatment facilities that participate in such a
State plan or such a waiver, mental health or substance use
disorder providers that participate in such a State plan or
such a waiver, clinical psychologists (as defined in
section 1861(ii)), nurse practitioners (as defined in
section 1861(aa)(5)) with respect to the provision of
psychiatric services, and clinical social workers (as
defined in section 1861(hh)(1))).''.
Subtitle B--Abuse Deterrent Access
SEC. 6011. SHORT TITLE.
This subtitle may be cited at the ``Abuse Deterrent Access Act of
2018''.
SEC. 6012. STUDY ON ABUSE-DETERRENT OPIOID FORMULATIONS ACCESS BARRIERS
UNDER MEDICARE.
(a) In General.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
conduct a study and submit to Congress a report on--
(1) the adequacy of access to abuse-deterrent opioid
formulations for individuals with chronic pain enrolled in an MA-PD
plan under part C of title XVIII of the Social Security Act or a
prescription drug plan under part D of such title of such Act,
taking into account any barriers preventing such individuals from
accessing such formulations under such MA-PD or part D plans, such
as cost-sharing tiers, fail-first requirements, the price of such
formulations, and prior authorization requirements; and
(2) the effectiveness of abuse-deterrent opioid formulations in
preventing opioid abuse or misuse; the impact of the use of abuse-
deterrent opioid formulations on the use or abuse of other
prescription or illicit opioids (including changes in deaths from
such opioids); and other public health consequences of the use of
abuse-deterrent opioid formulations, such as an increase in rates
of human immunodeficiency virus.
(b) Definition of Abuse-Deterrent Opioid Formulation.--In this
section, the term ``abuse-deterrent opioid formulation'' means an
opioid that is a prodrug or that has certain abuse-deterrent
properties, such as physical or chemical barriers, agonist or
antagonist combinations, aversion properties, delivery system
mechanisms, or other features designed to prevent abuse of such opioid.
Subtitle C--Medicare Opioid Safety Education
SEC. 6021. 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.
Subtitle D--Opioid Addiction Action Plan
SEC. 6031. SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction Action Plan
Act''.
SEC. 6032. ACTION PLAN ON RECOMMENDATIONS FOR CHANGES UNDER MEDICARE
AND MEDICAID TO PREVENT OPIOIDS ADDICTIONS AND ENHANCE ACCESS TO
MEDICATION-ASSISTED TREATMENT.
(a) In General.--Not later than January 1, 2020, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary''), in collaboration with the Pain Management Best
Practices Inter-Agency Task Force convened under section 101(b) of the
Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-198),
shall develop an action plan as described in subsection (b).
(b) Action Plan Components.--The action plan shall include a review
by the Secretary of Medicare and Medicaid payment and coverage policies
that may be viewed as potential obstacles to an effective response to
the opioid crisis, and recommendations, as determined appropriate by
the Secretary, on the following:
(1) A review of payment and coverage policies under the
Medicare program under title XVIII of the Social Security Act and
the Medicaid program under title XIX of such Act, including a
review of coverage and payment under such programs of all
medication-assisted treatment approved by the Food and Drug
Administration related to the treatment of opioid use disorder and
other therapies that manage chronic and acute pain and treat and
minimize risk of opioid misuse and abuse, including in such review,
payment under the Medicare prospective payment system for inpatient
hospital services under section 1886(d) of such Act (42 U.S.C.
1395ww(d)) and the Medicare prospective payment system for hospital
outpatient department services under section 1833(t) of such Act
(42 U.S.C. 1395I(t)), to determine whether those payment policies
resulted in incentives or disincentives that have contributed to
the opioid crisis.
(2) Recommendations for payment and service delivery models to
be tested as appropriate by the Center for Medicare and Medicaid
Innovation and other federally authorized demonstration projects,
including value-based models, that may encourage the use of
appropriate medication-assisted treatment approved by the Food and
Drug Administration for the treatment of opioid use disorder and
other therapies that manage chronic and acute pain and treat and
minimize risk of opioid misuse and abuse.
(3) Recommendations for data collection that could facilitate
research and policy-making regarding prevention of opioid use
disorder as well as data that would aid the Secretary in making
coverage and payment decisions under the Medicare and Medicaid
programs related to the access to appropriate opioid dependence
treatments.
(4) A review of Medicare and Medicaid beneficiaries' access to
the full range of medication-assisted treatment approved by the
Food and Drug Administration for the treatment of opioid use
disorder and other therapies that manage chronic and acute pain and
treat and minimize risk of opioid misuse and abuse, including
access of beneficiaries residing in rural or medically underserved
communities.
(5) A review of payment and coverage policies under the
Medicare program and the Medicaid program related to medical
devices that are non-opioid based treatments approved by the Food
and Drug Administration for the management of acute pain and
chronic pain, for monitoring substance use withdrawal and
preventing overdoses of controlled substances, and for treating
substance use disorder, including barriers to patient access.
(c) Stakeholder Meetings.--
(1) In general.--Beginning not later than 3 months after the
date of the enactment of this section, the Secretary shall convene
a public stakeholder meeting to solicit public comment on the
components of the action plan described in subsection (b).
(2) Participants.--Participants of meetings described in
paragraph (1) shall include representatives from the Food and Drug
Administration and National Institutes of Health, biopharmaceutical
industry members, medical researchers, health care providers, the
medical device industry, the Medicare program, the Medicaid
program, and patient advocates.
(d) Request for Information.--Not later than 3 months after the
date of the enactment of this section, the Secretary shall issue a
request for information seeking public feedback regarding ways in which
the Centers for Medicare & Medicaid Services can help address the
opioid crisis through the development of and application of the action
plan.
(e) Report to Congress.--Not later than June 1, 2020, the Secretary
shall submit to Congress, and make public, a report that includes--
(1) a summary of the results of the Secretary's review and any
recommendations under the action plan;
(2) the Secretary's planned next steps with respect to the
action plan; and
(3) an evaluation of price trends for drugs used to reverse
opioid overdoses (such as naloxone), including recommendations on
ways to lower such prices for consumers.
(f) Definition of Medication-Assisted Treatment.--In this section,
the term ``medication-assisted treatment'' includes opioid treatment
programs, behavioral therapy, and medications to treat substance abuse
disorder.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders
in Medicare
SEC. 6041. SHORT TITLE.
This subtitle may be cited as the ``Advancing High Quality
Treatment for Opioid Use Disorders in Medicare Act''.
SEC. 6042. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is
amended by inserting after section 1866E (42 U.S.C. 1395cc-5) the
following new section:
``SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
``(a) Implementation of 4-Year Demonstration Program.--
``(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration program under this
title (in this section referred to as the `Program') to increase
access of applicable beneficiaries to opioid use disorder treatment
services, improve physical and mental health outcomes for such
beneficiaries, and to the extent possible, reduce expenditures
under this title. Under the Program, the Secretary shall make
payments under subsection (e) to participants (as defined in
subsection (c)(1)(A)) for furnishing opioid use disorder treatment
services delivered through opioid use disorder care teams, or
arranging for such services to be furnished, to applicable
beneficiaries participating in the Program.
``(2) Opioid use disorder treatment services.--For purposes of
this section, the term `opioid use disorder treatment services'--
``(A) means, with respect to an applicable beneficiary,
services that are furnished for the treatment of opioid use
disorders and that utilize drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act for the treatment of
opioid use disorders in an outpatient setting; and
``(B) includes--
``(i) medication-assisted treatment;
``(ii) treatment planning;
``(iii) psychiatric, psychological, or counseling
services (or any combination of such services), as
appropriate;
``(iv) social support services, as appropriate; and
``(v) care management and care coordination services,
including coordination with other providers of services and
suppliers not on an opioid use disorder care team.
``(b) Program Design.--
``(1) In general.--The Secretary shall design the Program in
such a manner to allow for the evaluation of the extent to which
the Program accomplishes the following purposes:
``(A) Reduces hospitalizations and emergency department
visits.
``(B) Increases use of medication-assisted treatment for
opioid use disorders.
``(C) Improves health outcomes of individuals with opioid
use disorders, including by reducing the incidence of
infectious diseases (such as hepatitis C and HIV).
``(D) Does not increase the total spending on items and
services under this title.
``(E) Reduces deaths from opioid overdose.
``(F) Reduces the utilization of inpatient residential
treatment.
``(2) Consultation.--In designing the Program, including the
criteria under subsection (e)(2)(A), the Secretary shall, not later
than 3 months after the date of the enactment of this section,
consult with specialists in the field of addiction, clinicians in
the primary care community, and beneficiary groups.
``(c) Participants; Opioid Use Disorder Care Teams.--
``(1) Participants.--
``(A) Definition.--In this section, the term `participant'
means an entity or individual--
``(i) that is otherwise enrolled under this title and
that is--
``(I) a physician (as defined in section
1861(r)(1));
``(II) a group practice comprised of at least one
physician described in subclause (I);
``(III) a hospital outpatient department;
``(IV) a federally qualified health center (as
defined in section 1861(aa)(4));
``(V) a rural health clinic (as defined in section
1861(aa)(2));
``(VI) a community mental health center (as defined
in section 1861(ff)(3)(B));
``(VII) a clinic certified as a certified community
behavioral health clinic pursuant to section 223 of the
Protecting Access to Medicare Act of 2014; or
``(VIII) any other individual or entity specified
by the Secretary;
``(ii) that applied for and was selected to participate
in the Program pursuant to an application and selection
process established by the Secretary; and
``(iii) that establishes an opioid use disorder care
team (as defined in paragraph (2)) through employing or
contracting with health care practitioners described in
paragraph (2)(A), and uses such team to furnish or arrange
for opioid use disorder treatment services in the
outpatient setting under the Program.
``(B) Preference.--In selecting participants for the
Program, the Secretary shall give preference to individuals and
entities that are located in areas with a prevalence of opioid
use disorders that is higher than the national average
prevalence.
``(2) Opioid use disorder care teams.--
``(A) In general.--For purposes of this section, the term
`opioid use disorder care team' means a team of health care
practitioners established by a participant described in
paragraph (1)(A) that--
``(i) shall include--
``(I) at least one physician (as defined in section
1861(r)(1)) furnishing primary care services or
addiction treatment services to an applicable
beneficiary; and
``(II) at least one eligible practitioner (as
defined in paragraph (3)), who may be a physician who
meets the criterion in subclause (I); and
``(ii) may include other practitioners licensed under
State law to furnish psychiatric, psychological,
counseling, and social services to applicable
beneficiaries.
``(B) Requirements for receipt of payment under program.--
In order to receive payments under subsection (e), each
participant in the Program shall--
``(i) furnish opioid use disorder treatment services
through opioid use disorder care teams to applicable
beneficiaries who agree to receive the services;
``(ii) meet minimum criteria, as established by the
Secretary; and
``(iii) submit to the Secretary, in such form, manner,
and frequency as specified by the Secretary, with respect
to each applicable beneficiary for whom opioid use disorder
treatment services are furnished by the opioid use disorder
care team, data and such other information as the Secretary
determines appropriate to--
``(I) monitor and evaluate the Program;
``(II) determine if minimum criteria are met under
clause (ii); and
``(III) determine the incentive payment under
subsection (e).
``(3) Eligible practitioner defined.--For purposes of this
section, the term `eligible practitioner' means a physician or
other health care practitioner, such as a nurse practitioner,
that--
``(A) is enrolled under section 1866(j)(1);
``(B) is authorized to prescribe or dispense narcotic drugs
to individuals for maintenance treatment or detoxification
treatment; and
``(C) has in effect a waiver in accordance with section
303(g) of the Controlled Substances Act for such purpose and is
otherwise in compliance with regulations promulgated by the
Substance Abuse and Mental Health Services Administration to
carry out such section.
``(d) Participation of Applicable Beneficiaries.--
``(1) Applicable beneficiary defined.--In this section, the
term `applicable beneficiary' means an individual who--
``(A) is entitled to, or enrolled for, benefits under part
A and enrolled for benefits under part B;
``(B) is not enrolled in a Medicare Advantage plan under
part C;
``(C) has a current diagnosis for an opioid use disorder;
and
``(D) meets such other criteria as the Secretary determines
appropriate.
Such term shall include an individual who is dually eligible for
benefits under this title and title XIX if such individual
satisfies the criteria described in subparagraphs (A) through (D).
``(2) Voluntary beneficiary participation; limitation on number
of beneficiaries.--An applicable beneficiary may participate in the
Program on a voluntary basis and may terminate participation in the
Program at any time. Not more than 20,000 applicable beneficiaries
may participate in the Program at any time.
``(3) Services.--In order to participate in the Program, an
applicable beneficiary shall agree to receive opioid use disorder
treatment services from a participant. Participation under the
Program shall not affect coverage of or payment for any other item
or service under this title for the applicable beneficiary.
``(4) Beneficiary access to services.--Nothing in this section
shall be construed as encouraging providers to limit applicable
beneficiary access to services covered under this title, and
applicable beneficiaries shall not be required to relinquish access
to any benefit under this title as a condition of receiving
services from a participant in the Program.
``(e) Payments.--
``(1) Per applicable beneficiary per month care management
fee.--
``(A) In general.--The Secretary shall establish a schedule
of per applicable beneficiary per month care management fees.
Such a per applicable beneficiary per month care management fee
shall be paid to a participant in addition to any other amount
otherwise payable under this title to the health care
practitioners in the participant's opioid use disorder care
team or, if applicable, to the participant. A participant may
use such per applicable beneficiary per month care management
fee to deliver additional services to applicable beneficiaries,
including services not otherwise eligible for payment under
this title.
``(B) Payment amounts.--In carrying out subparagraph (A),
the Secretary may--
``(i) consider payments otherwise payable under this
title for opioid use disorder treatment services and the
needs of applicable beneficiaries;
``(ii) pay a higher per applicable beneficiary per
month care management fee for an applicable beneficiary who
receives more intensive treatment services from a
participant and for whom those services are appropriate
based on clinical guidelines for opioid use disorder care;
``(iii) pay a higher per applicable beneficiary per
month care management fee for the month in which the
applicable beneficiary begins treatment with a participant
than in subsequent months, to reflect the greater time and
costs required for the planning and initiation of
treatment, as compared to maintenance of treatment; and
``(iv) take into account whether a participant's opioid
use disorder care team refers applicable beneficiaries to
other suppliers or providers for any opioid use disorder
treatment services.
``(C) No duplicate payment.--The Secretary shall make
payments under this paragraph to only one participant for
services furnished to an applicable beneficiary during a
calendar month.
``(2) Incentive payments.--
``(A) In general.--Under the Program, the Secretary shall
establish a performance-based incentive payment, which shall be
paid (using a methodology established and at a time determined
appropriate by the Secretary) to participants based on the
performance of participants with respect to criteria, as
determined appropriate by the Secretary, in accordance with
subparagraph (B).
``(B) Criteria.--
``(i) In general.--Criteria described in subparagraph
(A) may include consideration of the following:
``(I) Patient engagement and retention in
treatment.
``(II) Evidence-based medication-assisted
treatment.
``(III) Other criteria established by the
Secretary.
``(ii) Required consultation and consideration.--In
determining criteria described in subparagraph (A), the
Secretary shall--
``(I) consult with stakeholders, including
clinicians in the primary care community and in the
field of addiction medicine; and
``(II) consider existing clinical guidelines for
the treatment of opioid use disorders.
``(C) No duplicate payment.--The Secretary shall ensure
that no duplicate payments under this paragraph are made with
respect to an applicable beneficiary.
``(f) Multipayer Strategy.--In carrying out the Program, the
Secretary shall encourage other payers to provide similar payments and
to use similar criteria as applied under the Program under subsection
(e)(2)(C). The Secretary may enter into a memorandum of understanding
with other payers to align the methodology for payment provided by such
a payer related to opioid use disorder treatment services with such
methodology for payment under the Program.
``(g) Evaluation.--
``(1) In general.--The Secretary shall conduct an intermediate
and final evaluation of the program. Each such evaluation shall
determine the extent to which each of the purposes described in
subsection (b) have been accomplished under the Program.
``(2) Reports.--The Secretary shall submit to Congress--
``(A) a report with respect to the intermediate evaluation
under paragraph (1) not later than 3 years after the date of
the implementation of the Program; and
``(B) a report with respect to the final evaluation under
paragraph (1) not later than 6 years after such date.
``(h) Funding.--
``(1) Administrative funding.--For the purposes of
implementing, administering, and carrying out the Program (other
than for purposes described in paragraph (2)), $5,000,000 shall be
available from the Federal Supplementary Medical Insurance Trust
Fund under section 1841.
``(2) Care management fees and incentives.--For the purposes of
making payments under subsection (e), $10,000,000 shall be
available from the Federal Supplementary Medical Insurance Trust
Fund under section 1841 for each of fiscal years 2021 through 2024.
``(3) Availability.--Amounts transferred under this subsection
for a fiscal year shall be available until expended.
``(i) Waivers.--The Secretary may waive any provision of this title
as may be necessary to carry out the Program under this section.''.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes
for Users' Treatment
SEC. 6051. SHORT TITLE.
This subtitle may be cited as the ``Responsible Education Achieves
Care and Healthy Outcomes for Users' Treatment Act of 2018'' or the
``REACH OUT Act of 2018''.
SEC. 6052. GRANTS TO PROVIDE TECHNICAL ASSISTANCE TO OUTLIER
PRESCRIBERS OF OPIOIDS.
(a) Grants Authorized.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall, through the
Centers for Medicare & Medicaid Services, award grants, contracts, or
cooperative agreements to eligible entities for the purposes described
in subsection (b).
(b) Use of Funds.--Grants, contracts, and cooperative agreements
awarded under subsection (a) shall be used to support eligible entities
through technical assistance--
(1) to educate and provide outreach to outlier prescribers of
opioids about best practices for prescribing opioids;
(2) to educate and provide outreach to outlier prescribers of
opioids about non-opioid pain management therapies; and
(3) to reduce the amount of opioid prescriptions prescribed by
outlier prescribers of opioids.
(c) Application.--Each eligible entity seeking to receive a grant,
contract, or cooperative agreement under subsection (a) shall submit to
the Secretary an application, at such time, in such manner, and
containing such information as the Secretary may require.
(d) Geographic Distribution.--In awarding grants, contracts, and
cooperative agreements under this section, the Secretary shall
prioritize establishing technical assistance resources in each State.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means--
(A) an organization--
(i) that has demonstrated experience providing
technical assistance to health care professionals on a
State or regional basis; and
(ii) that has at least--
(I) one individual who is a representative of
consumers on its governing body; and
(II) one individual who is a representative of
health care providers on its governing body; or
(B) an entity that is a quality improvement entity with a
contract under part B of title XI of the Social Security Act
(42 U.S.C. 1320c et seq.).
(2) Outlier prescriber of opioids.--The term ``outlier
prescriber of opioids'' means, with respect to a period, a
prescriber identified by the Secretary under subparagraph (D)(ii)
of section 1860D-4(c)(4) of the Social Security Act (42 U.S.C.
1395w-104(c)(4)), as added by section 6065 of this Act, to be an
outlier prescriber of opioids for such period.
(3) Prescribers.--The term ``prescriber'' means any health care
professional, including a nurse practitioner or physician
assistant, who is licensed to prescribe opioids by the State or
territory in which such professional practices.
(f) Funding.--For purposes of implementing this section,
$75,000,000 shall be available from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 of the Social Security Act (42
U.S.C. 1395t), to remain available until expended.
Subtitle G--Preventing Addiction for Susceptible Seniors
SEC. 6061. SHORT TITLE.
This subtitle may be cited as the ``Preventing Addiction for
Susceptible Seniors Act of 2018'' or the ``PASS Act of 2018''.
SEC. 6062. ELECTRONIC PRIOR AUTHORIZATION FOR COVERED PART D DRUGS.
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
transmission 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. 6063. PROGRAM INTEGRITY TRANSPARENCY MEASURES UNDER MEDICARE PARTS
C AND D.
(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 (or other successor technology) 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 an entity responsible for
carrying out program integrity activities under this part and
part D) for the purpose of enabling through such portal (or
other successor technology)--
``(i) the referral by such plans of substantiated or
suspicious activities, as defined by the Secretary, 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 (or other successor technology)
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 (or other
successor technology) with respect to activities of
substantiated or suspicious activities of fraud, waste, or
abuse of a provider of services (including a prescriber) or
supplier, if such provider (including a 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
substantiated or suspicious activities of fraud, waste, and
abuse, using guidance such as what is provided in the Medicare
Program Integrity Manual 4.8. In carrying out this subsection,
a fraud hotline tip (as defined by the Secretary) without
further evidence shall not be treated as sufficient evidence
for substantiated fraud, waste, or abuse.
``(D) HIPAA compliant information only.--For purposes of
this subsection, communications may only occur if the
communications are permitted under the Federal regulations
(concerning the privacy of individually identifiable health
information) promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996.
``(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 (or other successor
technology) 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) of the Social
Security Act (42 U.S.C. 1395w-27(e)) 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 the investigations, 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' and a method for determining if a provider of
services prescribes inappropriate prescribing; and
``(ii) establish the process described in subparagraph
(B) and the types of information that shall 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. 6064. EXPANDING ELIGIBILITY FOR MEDICATION THERAPY MANAGEMENT
PROGRAMS UNDER PART D.
Section 1860D-4(c)(2)(A)(ii) of the Social Security Act (42 U.S.C.
1395w-104(c)(2)(A)(ii)) is amended--
(1) by redesignating subclauses (I) through (III) as items (aa)
through (cc), respectively, and adjusting the margins accordingly;
(2) by striking ``are part D eligible individuals who--'' and
inserting ``are the following:
``(I) Part D eligible individuals who--''; and
(3) by adding at the end the following new subclause:
``(II) Beginning January 1, 2021, at-risk
beneficiaries for prescription drug abuse (as defined
in paragraph (5)(C)).''.
SEC. 6065. 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 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 an outlier
prescriber of opioids, provide, subject to clause (iv), an
annual notification to such prescriber that such prescriber
has been so identified and that includes resources on
proper prescribing methods and other information as
specified in accordance with clause (iii).
``(ii) Identification of 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 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
geographic area, for identifying whether a prescriber
in a specialty and geographic area is an 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 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
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 outlier
prescribers.--In the case of a prescriber who the Secretary
determines is persistently identified under clause (ii) as
an outlier prescriber of opioids, the following shall
apply:
``(I) 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,
but only after other appropriate remedies have been
provided, such as the provision of education funded
through section 6052 of the SUPPORT for Patients and
Communities Act, for a period determined by the
Secretary as sufficient to correct the prescribing
patterns that lead to identification of such prescriber
as a persistent outlier prescriber of opioids. The
Secretary shall determine the length of the period for
which such prescriber is required to maintain such
enrollment, which shall be the minimum period necessary
to correct such prescribing patterns.
``(II) Not less frequently than annually (and in a
form and manner determined appropriate by the
Secretary), the Secretary, consistent with
clause(iv)(I), 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. 6066. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle and the amendments made by this
subtitle. Such requirements shall be carried out using amounts
otherwise authorized to be appropriated.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
SEC. 6071. SHORT TITLE.
This subtitle may be cited as the ``Expanding Oversight of Opioid
Prescribing and Payment Act of 2018''.
SEC. 6072. MEDICARE PAYMENT ADVISORY COMMISSION REPORT ON OPIOID
PAYMENT, ADVERSE INCENTIVES, AND DATA UNDER THE MEDICARE PROGRAM.
Not later than March 15, 2019, the Medicare Payment Advisory
Commission shall submit to Congress a report on, with respect to the
Medicare program under title XVIII of the Social Security Act, the
following:
(1) A description of how the Medicare program pays for pain
management treatments (both opioid and non-opioid pain management
alternatives) in both inpatient and outpatient hospital settings.
(2) The identification of incentives under the hospital
inpatient prospective payment system under section 1886 of the
Social Security Act (42 U.S.C. 1395ww) and incentives under the
hospital outpatient prospective payment system under section
1833(t) of such Act (42 U.S.C. 1395l(t)) for prescribing opioids
and incentives under each such system for prescribing non-opioid
treatments, and recommendations as the Commission deems appropriate
for addressing any of such incentives that are adverse incentives.
(3) A description of how opioid use is tracked and monitored
through Medicare claims data and other mechanisms and the
identification of any areas in which further data and methods are
needed for improving data and understanding of opioid use.
SEC. 6073. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle. Such requirements shall be carried
out using amounts otherwise authorized to be appropriated.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
SEC. 6081. SHORT TITLE.
This subtitle may be cited as the ``Dr. Todd Graham Pain
Management, Treatment, and Recovery Act of 2018''.
SEC. 6082. REVIEW AND ADJUSTMENT OF PAYMENTS UNDER THE MEDICARE
OUTPATIENT PROSPECTIVE PAYMENT SYSTEM TO AVOID FINANCIAL INCENTIVES TO
USE OPIOIDS INSTEAD OF NON-OPIOID ALTERNATIVE TREATMENTS.
(a) Outpatient Prospective Payment System.--Section 1833(t) of the
Social Security Act (42 U.S.C. 1395l(t)) is amended by adding at the
end the following new paragraph:
``(22) Review and revisions of payments for non-opioid
alternative treatments.--
``(A) In general.--With respect to payments made under this
subsection for covered OPD services (or groups of services),
including covered OPD services assigned to a comprehensive
ambulatory payment classification, the Secretary--
``(i) shall, as soon as practicable, conduct a review
(part of which may include a request for information) of
payments for opioids and evidence-based non-opioid
alternatives for pain management (including drugs and
devices, nerve blocks, surgical injections, and
neuromodulation) with a goal of ensuring that there are not
financial incentives to use opioids instead of non-opioid
alternatives;
``(ii) may, as the Secretary determines appropriate,
conduct subsequent reviews of such payments; and
``(iii) shall consider the extent to which revisions
under this subsection to such payments (such as the
creation of additional groups of covered OPD services to
classify separately those procedures that utilize opioids
and non-opioid alternatives for pain management) would
reduce payment incentives to use opioids instead of non-
opioid alternatives for pain management.
``(B) Priority.--In conducting the review under clause (i)
of subparagraph (A) and considering revisions under clause
(iii) of such subparagraph, the Secretary shall focus on
covered OPD services (or groups of services) assigned to a
comprehensive ambulatory payment classification, ambulatory
payment classifications that primarily include surgical
services, and other services determined by the Secretary which
generally involve treatment for pain management.
``(C) Revisions.--If the Secretary identifies revisions to
payments pursuant to subparagraph (A)(iii), the Secretary
shall, as determined appropriate, begin making such revisions
for services furnished on or after January 1, 2020. Revisions
under the previous sentence shall be treated as adjustments for
purposes of application of paragraph (9)(B).
``(D) Rules of construction.--Nothing in this paragraph
shall be construed to preclude the Secretary--
``(i) from conducting a demonstration before making the
revisions described in subparagraph (C); or
``(ii) prior to implementation of this paragraph, from
changing payments under this subsection for covered OPD
services (or groups of services) which include opioids or
non-opioid alternatives for pain management.''.
(b) Ambulatory Surgical Centers.--Section 1833(i) of the Social
Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the
following new paragraph:
``(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including the second
sentence of subparagraph (C) of such paragraph, to payment for services
under this subsection, and make such revisions under this paragraph, in
an appropriate manner (as determined by the Secretary).''.
SEC. 6083. EXPANDING ACCESS UNDER THE MEDICARE PROGRAM TO ADDICTION
TREATMENT IN FEDERALLY QUALIFIED HEALTH CENTERS AND RURAL HEALTH
CLINICS.
(a) Federally Qualified Health Centers.--Section 1834(o) of the
Social Security Act (42 U.S.C. 1395m(o)) is amended by adding at the
end the following new paragraph:
``(3) Additional payments for certain fqhcs with physicians or
other practitioners receiving data 2000 waivers.--
``(A) In general.--In the case of a Federally qualified
health center with respect to which, beginning on or after
January 1, 2019, Federally qualified health center services (as
defined in section 1861(aa)(3)) are furnished for the treatment
of opioid use disorder by a physician or practitioner who meets
the requirements described in subparagraph (C), the Secretary
shall, subject to availability of funds under subparagraph (D),
make a payment (at such time and in such manner as specified by
the Secretary) to such Federally qualified health center after
receiving and approving an application submitted by such
Federally qualified health center under subparagraph (B). Such
a payment shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training for
purposes of receiving a waiver described in subparagraph
(C)(ii). Such a payment may be made only one time with respect
to each such physician or practitioner.
``(B) Application.--In order to receive a payment described
in subparagraph (A), a Federally qualified health center shall
submit to the Secretary an application for such a payment at
such time, in such manner, and containing such information as
specified by the Secretary. A Federally qualified health center
may apply for such a payment for each physician or practitioner
described in subparagraph (A) furnishing services described in
such subparagraph at such center.
``(C) Requirements.--For purposes of subparagraph (A), the
requirements described in this subparagraph, with respect to a
physician or practitioner, are the following:
``(i) The physician or practitioner is employed by or
working under contract with a Federally qualified health
center described in subparagraph (A) that submits an
application under subparagraph (B).
``(ii) The physician or practitioner first receives a
waiver under section 303(g) of the Controlled Substances
Act on or after January 1, 2019.
``(D) Funding.--For purposes of making payments under this
paragraph, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $6,000,000, which shall
remain available until expended.''.
(b) Rural Health Clinic.--Section 1833 of the Social Security Act
(42 U.S.C. 1395l) is amended--
(1) by redesignating the subsection (z) relating to medical
review of spinal subluxation services as subsection (aa); and
(2) by adding at the end the following new subsection:
``(bb) Additional Payments for Certain Rural Health Clinics With
Physicians or Practitioners Receiving DATA 2000 Waivers.--
``(1) In general.--In the case of a rural health clinic with
respect to which, beginning on or after January 1, 2019, rural
health clinic services (as defined in section 1861(aa)(1)) are
furnished for the treatment of opioid use disorder by a physician
or practitioner who meets the requirements described in paragraph
(3), the Secretary shall, subject to availability of funds under
paragraph (4), make a payment (at such time and in such manner as
specified by the Secretary) to such rural health clinic after
receiving and approving an application described in paragraph (2).
Such payment shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training for purposes
of receiving a waiver described in paragraph (3)(B). Such payment
may be made only one time with respect to each such physician or
practitioner.
``(2) Application.--In order to receive a payment described in
paragraph (1), a rural health clinic shall submit to the Secretary
an application for such a payment at such time, in such manner, and
containing such information as specified by the Secretary. A rural
health clinic may apply for such a payment for each physician or
practitioner described in paragraph (1) furnishing services
described in such paragraph at such clinic.
``(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect to a
physician or practitioner, are the following:
``(A) The physician or practitioner is employed by or
working under contract with a rural health clinic described in
paragraph (1) that submits an application under paragraph (2).
``(B) The physician or practitioner first receives a waiver
under section 303(g) of the Controlled Substances Act on or
after January 1, 2019.
``(4) Funding.--For purposes of making payments under this
subsection, there are appropriated, out of amounts in the Treasury
not otherwise appropriated, $2,000,000, which shall remain
available until expended.''.
SEC. 6084. STUDYING THE AVAILABILITY OF SUPPLEMENTAL BENEFITS DESIGNED
TO TREAT OR PREVENT SUBSTANCE USE DISORDERS UNDER MEDICARE ADVANTAGE
PLANS.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall submit to Congress
a report on the availability of supplemental health care benefits (as
described in section 1852(a)(3)(A) of the Social Security Act (42
U.S.C. 1395w-22(a)(3)(A))) designed to treat or prevent substance use
disorders under Medicare Advantage plans offered under part C of title
XVIII of such Act. Such report shall include the analysis described in
subsection (c) and any differences in the availability of such benefits
under specialized MA plans for special needs individuals (as defined in
section 1859(b)(6) of such Act (42 U.S.C. 1395w-28(b)(6))) offered to
individuals entitled to medical assistance under title XIX of such Act
and other such Medicare Advantage plans.
(b) Consultation.--The Secretary shall develop the report described
in subsection (a) in consultation with relevant stakeholders,
including--
(1) individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act;
(2) entities who advocate on behalf of such individuals;
(3) Medicare Advantage organizations;
(4) pharmacy benefit managers; and
(5) providers of services and suppliers (as such terms are
defined in section 1861 of such Act (42 U.S.C. 1395x)).
(c) Contents.--The report described in subsection (a) shall include
an analysis on the following:
(1) The extent to which plans described in such subsection
offer supplemental health care benefits relating to coverage of--
(A) medication-assisted treatments for opioid use,
substance use disorder counseling, peer recovery support
services, or other forms of substance use disorder treatments
(whether furnished in an inpatient or outpatient setting); and
(B) non-opioid alternatives for the treatment of pain.
(2) Challenges associated with such plans offering supplemental
health care benefits relating to coverage of items and services
described in subparagraph (A) or (B) of paragraph (1).
(3) The impact, if any, of increasing the applicable rebate
percentage determined under section 1854(b)(1)(C) of the Social
Security Act (42 U.S.C. 1395w-24(b)(1)(C)) for plans offering such
benefits relating to such coverage would have on the availability
of such benefits relating to such coverage offered under Medicare
Advantage plans.
(4) Potential ways to improve upon such coverage or to
incentivize such plans to offer additional supplemental health care
benefits relating to such coverage.
SEC. 6085. CLINICAL PSYCHOLOGIST SERVICES MODELS UNDER THE CENTER FOR
MEDICARE AND MEDICAID INNOVATION; GAO STUDY AND REPORT.
(a) CMI Models.--Section 1115A(b)(2)(B) of the Social Security Act
(42 U.S.C. 1315a(b)(2)(B)), as amended by section 6001, is further
amended by adding at the end the following new clauses:
``(xxvi) Supporting ways to familiarize individuals
with the availability of coverage under part B of title
XVIII for qualified psychologist services (as defined in
section 1861(ii)).
``(xxvii) Exploring ways to avoid unnecessary
hospitalizations or emergency department visits for mental
and behavioral health services (such as for treating
depression) through use of a 24-hour, 7-day a week help
line that may inform individuals about the availability of
treatment options, including the availability of qualified
psychologist services (as defined in section 1861(ii)).''.
(b) GAO Study and Report.--Not later than 18 months after the date
of the enactment of this Act, the Comptroller General of the United
States shall conduct a study, and submit to Congress a report, on
mental and behavioral health services under the Medicare program under
title XVIII of the Social Security Act, including an examination of the
following:
(1) Information about services furnished by psychiatrists,
clinical psychologists, and other professionals.
(2) Information about ways that Medicare beneficiaries
familiarize themselves about the availability of Medicare payment
for qualified psychologist services (as defined in section 1861(ii)
of the Social Security Act (42 U.S.C. 1395x(ii)) and ways that the
provision of such information could be improved.
SEC. 6086. DR. TODD GRAHAM PAIN MANAGEMENT STUDY.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall conduct a study analyzing best
practices as well as payment and coverage for pain management services
under title XVIII of the Social Security Act and submit to the
Committee on Ways and Means and the Committee on Energy and Commerce of
the House of Representatives and the Committee on Finance of the Senate
a report containing options for revising payment to providers and
suppliers of services and coverage related to the use of multi-
disciplinary, evidence-based, non-opioid treatments for acute and
chronic pain management for individuals entitled to benefits under part
A or enrolled under part B of title XVIII of the Social Security Act.
The Secretary shall make such report available on the public website of
the Centers for Medicare & Medicaid Services.
(b) Consultation.--In developing the report described in subsection
(a), the Secretary shall consult with--
(1) relevant agencies within the Department of Health and Human
Services;
(2) licensed and practicing osteopathic and allopathic
physicians, behavioral health practitioners, physician assistants,
nurse practitioners, dentists, pharmacists, and other providers of
health services;
(3) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(4) substance abuse and mental health professional
organizations;
(5) pain management professional organizations and advocacy
entities, including individuals who personally suffer chronic pain;
(6) medical professional organizations and medical specialty
organizations;
(7) licensed health care providers who furnish alternative pain
management services;
(8) organizations with expertise in the development of
innovative medical technologies for pain management;
(9) beneficiary advocacy organizations; and
(10) other organizations with expertise in the assessment,
diagnosis, treatment, and management of pain, as determined
appropriate by the Secretary.
(c) Contents.--The report described in subsection (a) shall include
the following:
(1) An analysis of payment and coverage under title XVIII of
the Social Security Act with respect to the following:
(A) Evidence-based treatments and technologies for chronic
or acute pain, including such treatments that are covered, not
covered, or have limited coverage under such title.
(B) Evidence-based treatments and technologies that monitor
substance use withdrawal and prevent overdoses of opioids.
(C) Evidence-based treatments and technologies that treat
substance use disorders.
(D) Items and services furnished by practitioners through a
multi-disciplinary treatment model for pain management,
including the patient-centered medical home.
(E) Items and services furnished to beneficiaries with
psychiatric disorders, substance use disorders, or who are at
risk of suicide, or have comorbidities and require consultation
or management of pain with one or more specialists in pain
management, mental health, or addiction treatment.
(2) An evaluation of the following:
(A) Barriers inhibiting individuals entitled to benefits
under part A or enrolled under part B of such title from
accessing treatments and technologies described in
subparagraphs (A) through (E) of paragraph (1).
(B) Costs and benefits associated with potential expansion
of coverage under such title to include items and services not
covered under such title that may be used for the treatment of
pain, such as acupuncture, therapeutic massage, and items and
services furnished by integrated pain management programs.
(C) Pain management guidance published by the Federal
Government that may be relevant to coverage determinations or
other coverage requirements under title XVIII of the Social
Security Act.
(3) An assessment of all guidance published by the Department
of Health and Human Services on or after January 1, 2016, relating
to the prescribing of opioids. Such assessment shall consider
incorporating into such guidance relevant elements of the ``Va/DoD
Clinical Practice Guideline for Opioid Therapy for Chronic Pain''
published in February 2017 by the Department of Veterans Affairs
and Department of Defense, including adoption of elements of the
Department of Defense and Department of Veterans Affairs pain
rating scale.
(4) The options described in subsection (d).
(5) The impact analysis described in subsection (e).
(d) Options.--The options described in this subsection are, with
respect to individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act, legislative and
administrative options for accomplishing the following:
(1) Improving coverage of and payment for pain management
therapies without the use of opioids, including interventional pain
therapies, and options to augment opioid therapy with other
clinical and complementary, integrative health services to minimize
the risk of substance use disorder, including in a hospital
setting.
(2) Improving coverage of and payment for medical devices and
non-opioid based pharmacological and non-pharmacological therapies
approved or cleared by the Food and Drug Administration for the
treatment of pain as an alternative or augment to opioid therapy.
(3) Improving and disseminating treatment strategies for
beneficiaries with psychiatric disorders, substance use disorders,
or who are at risk of suicide, and treatment strategies to address
health disparities related to opioid use and opioid abuse
treatment.
(4) Improving and disseminating treatment strategies for
beneficiaries with comorbidities who require a consultation or
comanagement of pain with one or more specialists in pain
management, mental health, or addiction treatment, including in a
hospital setting.
(5) Educating providers on risks of coadministration of opioids
and other drugs, particularly benzodiazepines.
(6) Ensuring appropriate case management for beneficiaries who
transition between inpatient and outpatient hospital settings, or
between opioid therapy to non-opioid therapy, which may include the
use of care transition plans.
(7) Expanding outreach activities designed to educate providers
of services and suppliers under the Medicare program and
individuals entitled to benefits under part A or under part B of
such title on alternative, non-opioid therapies to manage and treat
acute and chronic pain.
(8) Creating a beneficiary education tool on alternatives to
opioids for chronic pain management.
(e) Impact Analysis.--The impact analysis described in this
subsection consists of an analysis of any potential effects
implementing the options described in subsection (d) would have--
(1) on expenditures under the Medicare program; and
(2) on preventing or reducing opioid addiction for individuals
receiving benefits under the Medicare program.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
SEC. 6091. SHORT TITLE.
This subtitle may be cited as the ``Combating Opioid Abuse for Care
in Hospitals Act of 2018'' or the ``COACH Act of 2018''.
SEC. 6092. DEVELOPING GUIDANCE ON PAIN MANAGEMENT AND OPIOID USE
DISORDER PREVENTION FOR HOSPITALS RECEIVING PAYMENT UNDER PART A OF THE
MEDICARE PROGRAM.
(a) In General.--Not later than July 1, 2019, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall develop and publish on the public website of the
Centers for Medicare & Medicaid Services guidance for hospitals
receiving payment under part A of title XVIII of the Social Security
Act (42 U.S.C. 1395c et seq.) on pain management strategies and opioid
use disorder prevention strategies with respect to individuals entitled
to benefits under such part.
(b) Consultation.--In developing the guidance described in
subsection (a), the Secretary shall consult with relevant stakeholders,
including--
(1) medical professional organizations;
(2) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(3) health care consumers or groups representing such
consumers; and
(4) other entities determined appropriate by the Secretary.
(c) Contents.--The guidance described in subsection (a) shall
include, with respect to hospitals and individuals described in such
subsection, the following:
(1) Best practices regarding evidence-based screening and
practitioner education initiatives relating to screening and
treatment protocols for opioid use disorder, including--
(A) methods to identify such individuals at-risk of opioid
use disorder, including risk stratification;
(B) ways to prevent, recognize, and treat opioid overdoses;
and
(C) resources available to such individuals, such as opioid
treatment programs, peer support groups, and other recovery
programs.
(2) Best practices for such hospitals to educate practitioners
furnishing items and services at such hospital with respect to pain
management and substance use disorders, including education on--
(A) the adverse effects of prolonged opioid use;
(B) non-opioid, evidence-based, non-pharmacological pain
management treatments;
(C) monitoring programs for individuals who have been
prescribed opioids; and
(D) the prescribing of naloxone along with an initial
opioid prescription.
(3) Best practices for such hospitals to make such individuals
aware of the risks associated with opioid use (which may include
use of the notification template described in paragraph (4)).
(4) A notification template developed by the Secretary, for use
as appropriate, for such individuals who are prescribed an opioid
that--
(A) explains the risks and side effects associated with
opioid use (including the risks of addiction and overdose) and
the importance of adhering to the prescribed treatment regimen,
avoiding medications that may have an adverse interaction with
such opioid, and storing such opioid safely and securely;
(B) highlights multimodal and evidence-based non-opioid
alternatives for pain management;
(C) encourages such individuals to talk to their health
care providers about such alternatives;
(D) provides for a method (through signature or otherwise)
for such an individual, or person acting on such individual's
behalf, to acknowledge receipt of such notification template;
(E) is worded in an easily understandable manner and made
available in multiple languages determined appropriate by the
Secretary; and
(F) includes any other information determined appropriate
by the Secretary.
(5) Best practices for such hospital to track opioid
prescribing trends by practitioners furnishing items and services
at such hospital, including--
(A) ways for such hospital to establish target levels,
taking into account the specialties of such practitioners and
the geographic area in which such hospital is located, with
respect to opioids prescribed by such practitioners;
(B) guidance on checking the medical records of such
individuals against information included in prescription drug
monitoring programs;
(C) strategies to reduce long-term opioid prescriptions;
and
(D) methods to identify such practitioners who may be over-
prescribing opioids.
(6) Other information the Secretary determines appropriate,
including any such information from the Opioid Safety Initiative
established by the Department of Veterans Affairs or the Opioid
Overdose Prevention Toolkit published by the Substance Abuse and
Mental Health Services Administration.
SEC. 6093. REQUIRING THE REVIEW OF QUALITY MEASURES RELATING TO OPIOIDS
AND OPIOID USE DISORDER TREATMENTS FURNISHED UNDER THE MEDICARE PROGRAM
AND OTHER FEDERAL HEALTH CARE PROGRAMS.
Section 1890A of the Social Security Act (42 U.S.C. 1395aaa-1) is
amended by adding at the end the following new subsection:
``(g) Technical Expert Panel Review of Opioid and Opioid Use
Disorder Quality Measures.--
``(1) In general.--Not later than 180 days after the date of
the enactment of this subsection, the Secretary shall establish a
technical expert panel for purposes of reviewing quality measures
relating to opioids and opioid use disorders, including care,
prevention, diagnosis, health outcomes, and treatment furnished to
individuals with opioid use disorders. The Secretary may use the
entity with a contract under section 1890(a) and amend such
contract as necessary to provide for the establishment of such
technical expert panel.
``(2) Review and assessment.--Not later than 1 year after the
date the technical expert panel described in paragraph (1) is
established (and periodically thereafter as the Secretary
determines appropriate), the technical expert panel shall--
``(A) review quality measures that relate to opioids and
opioid use disorders, including existing measures and those
under development;
``(B) identify gaps in areas of quality measurement that
relate to opioids and opioid use disorders, and identify
measure development priorities for such measure gaps; and
``(C) make recommendations to the Secretary on quality
measures with respect to opioids and opioid use disorders for
purposes of improving care, prevention, diagnosis, health
outcomes, and treatment, including recommendations for
revisions of such measures, need for development of new
measures, and recommendations for including such measures in
the Merit-Based Incentive Payment System under section 1848(q),
the alternative payment models under section 1833(z)(3)(C), the
shared savings program under section 1899, the quality
reporting requirements for inpatient hospitals under section
1886(b)(3)(B)(viii), and the hospital value-based purchasing
program under section 1886(o).
``(3) Consideration of measures by secretary.--The Secretary
shall consider--
``(A) using opioid and opioid use disorder measures
(including measures used under the Merit-Based Incentive
Payment System under section 1848(q), measures recommended
under paragraph (2)(C), and other such measures identified by
the Secretary) in alternative payment models under section
1833(z)(3)(C) and in the shared savings program under section
1899; and
``(B) using opioid measures described in subparagraph (A),
as applicable, in the quality reporting requirements for
inpatient hospitals under section 1886(b)(3)(B)(viii), and in
the hospital value-based purchasing program under section
1886(o).
``(4) Prioritization of measure development.--The Secretary
shall prioritize for measure development the gaps in quality
measures identified under paragraph (2)(B).
``(5) Prioritization of measure endorsement.--The Secretary--
``(A) during the period beginning on the date of the
enactment of this subsection and ending on December 31, 2023,
shall prioritize the endorsement of measures relating to
opioids and opioid use disorders by the entity with a contract
under subsection (a) of section 1890 in connection with
endorsement of measures described in subsection (b)(2) of such
section; and
``(B) on and after January 1, 2024, may prioritize the
endorsement of such measures by such entity.''.
SEC. 6094. TECHNICAL EXPERT PANEL ON REDUCING SURGICAL SETTING OPIOID
USE; DATA COLLECTION ON PERIOPERATIVE OPIOID USE.
(a) Technical Expert Panel on Reducing Surgical Setting Opioid
Use.--
(1) In general.--Not later than 6 months after the date of the
enactment of this Act, the Secretary of Health and Human Services
shall convene a technical expert panel, including medical and
surgical specialty societies and hospital organizations, to provide
recommendations on reducing opioid use in the inpatient and
outpatient surgical settings and on best practices for pain
management, including with respect to the following:
(A) Approaches that limit patient exposure to opioids
during the perioperative period, including pre-surgical and
post-surgical injections, and that identify such patients at
risk of opioid use disorder pre-operation.
(B) Shared decision making with patients and families on
pain management, including a review of payment to ensure
payment under the Medicare program under title XVIII of the
Social Security Act accounts for time spent on shared decision
making.
(C) Education on the safe use, storage, and disposal of
opioids.
(D) Prevention of opioid misuse and abuse after discharge.
(E) Development of a clinical algorithm to identify and
treat at-risk, opiate-tolerant patients and reduce reliance on
opioids for acute pain during the perioperative period.
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to Congress and
make public a report containing the recommendations developed under
paragraph (1) and an action plan for broader implementation of pain
management protocols that limit the use of opioids in the
perioperative setting and upon discharge from such setting.
(b) Data Collection on Perioperative Opioid Use.--Not later than 1
year after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a report that
contains the following:
(1) The diagnosis-related group codes identified by the
Secretary as having the highest volume of surgeries.
(2) With respect to each of such diagnosis-related group codes
so identified, a determination by the Secretary of the data that is
both available and reported on opioid use following such surgeries,
such as with respect to--
(A) surgical volumes, practices, and opioid prescribing
patterns;
(B) opioid consumption, including--
(i) perioperative days of therapy;
(ii) average daily dose at the hospital, including
dosage greater than 90 milligram morphine equivalent;
(iii) post-discharge prescriptions and other
combination drugs that are used before intervention and
after intervention;
(iv) quantity and duration of opioid prescription at
discharge; and
(v) quantity consumed and number of refills;
(C) regional anesthesia and analgesia practices, including
pre-surgical and post-surgical injections;
(D) naloxone reversal;
(E) post-operative respiratory failure;
(F) information about storage and disposal; and
(G) such other information as the Secretary may specify.
(3) Recommendations for improving data collection on
perioperative opioid use, including an analysis to identify and
reduce barriers to collecting, reporting, and analyzing the data
described in paragraph (2), including barriers related to
technological availability.
SEC. 6095. REQUIRING THE POSTING AND PERIODIC UPDATE OF OPIOID
PRESCRIBING GUIDANCE FOR MEDICARE BENEFICIARIES.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall post on the public
website of the Centers for Medicare & Medicaid Services all guidance
published by the Department of Health and Human Services on or after
January 1, 2016, relating to the prescribing of opioids and applicable
to opioid prescriptions for individuals entitled to benefits under part
A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.)
or enrolled under part B of such title of such Act (42 U.S.C. 1395j et
seq.).
(b) Update of Guidance.--
(1) Periodic update.--The Secretary shall, in consultation with
the entities specified in paragraph (2), periodically (as
determined appropriate by the Secretary) update guidance described
in subsection (a) and revise the posting of such guidance on the
website described in such subsection.
(2) Consultation.--The entities specified in this paragraph are
the following:
(A) Medical professional organizations.
(B) Providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x)).
(C) Health care consumers or groups representing such
consumers.
(D) Other entities determined appropriate by the Secretary.
Subtitle K--Providing Reliable Options for Patients and Educational
Resources
SEC. 6101. SHORT TITLE.
This subtitle may be cited as the ``Providing Reliable Options for
Patients and Educational Resources Act of 2018'' or the ``PROPER Act of
2018''.
SEC. 6102. REQUIRING MEDICARE ADVANTAGE PLANS AND PART D PRESCRIPTION
DRUG PLANS TO INCLUDE INFORMATION ON RISKS ASSOCIATED WITH OPIOIDS AND
COVERAGE OF NONPHARMACOLOGICAL THERAPIES AND NONOPIOID MEDICATIONS OR
DEVICES USED TO TREAT PAIN.
Section 1860D-4(a)(1) of the Social Security Act (42 U.S.C. 1395w-
104(a)(1)) is amended--
(1) in subparagraph (A), by inserting ``, subject to
subparagraph (C),'' before ``including'';
(2) in subparagraph (B), by adding at the end the following new
clause:
``(vi) For plan year 2021 and each subsequent plan
year, subject to subparagraph (C), with respect to the
treatment of pain--
``(I) the risks associated with prolonged opioid
use; and
``(II) coverage of nonpharmacological therapies,
devices, and nonopioid medications--
``(aa) in the case of an MA-PD plan under part
C, under such plan; and
``(bb) in the case of a prescription drug plan,
under such plan and under parts A and B.''; and
(3) by adding at the end the following new subparagraph:
``(C) Targeted provision of information.--A PDP sponsor of
a prescription drug plan may, in lieu of disclosing the
information described in subparagraph (B)(vi) to each enrollee
under the plan, disclose such information through mail or
electronic communications to a subset of enrollees under the
plan, such as enrollees who have been prescribed an opioid in
the previous 2-year period.''.
SEC. 6103. REQUIRING MEDICARE ADVANTAGE PLANS AND PRESCRIPTION DRUG
PLANS TO PROVIDE INFORMATION ON THE SAFE DISPOSAL OF PRESCRIPTION
DRUGS.
(a) Medicare Advantage.--Section 1852 of the Social Security Act
(42 U.S.C. 1395w-22) is amended by adding at the end the following new
subsection:
``(n) Provision of Information Relating to the Safe Disposal of
Certain Prescription Drugs.--
``(1) In general.--In the case of an individual enrolled under
an MA or MA-PD plan who is furnished an in-home health risk
assessment on or after January 1, 2021, such plan shall ensure that
such assessment includes information on the safe disposal of
prescription drugs that are controlled substances that meets the
criteria established under paragraph (2). Such information shall
include information on drug takeback programs that meet such
requirements determined appropriate by the Secretary and
information on in-home disposal.
``(2) Criteria.--The Secretary shall, through rulemaking,
establish criteria the Secretary determines appropriate with
respect to information provided to an individual to ensure that
such information sufficiently educates such individual on the safe
disposal of prescription drugs that are controlled substances.''.
(b) Prescription Drug Plans.--Section 1860D-4(c)(2)(B) of the
Social Security Act (42 U.S.C. 1395w-104(c)(2)(B)) is amended--
(1) by striking ``may include elements that promote'';
(2) by redesignating clauses (i) through (iii) as subclauses
(I) through (III) and adjusting the margins accordingly;
(3) by inserting before subclause (I), as so redesignated, the
following new clause:
``(i) may include elements that promote--'';
(4) in subclause (III), as so redesignated, by striking the
period at the end and inserting ``; and''; and
(5) by adding at the end the following new clause:
``(ii) with respect to plan years beginning on or after
January 1, 2021, shall provide for--
``(I) the provision of information to the enrollee
on the safe disposal of prescription drugs that are
controlled substances that meets the criteria
established under section 1852(n)(2), including
information on drug takeback programs that meet such
requirements determined appropriate by the Secretary
and information on in-home disposal; and
``(II) cost-effective means by which an enrollee
may so safely dispose of such drugs.''.
SEC. 6104. REVISING MEASURES USED UNDER THE HOSPITAL CONSUMER
ASSESSMENT OF HEALTHCARE PROVIDERS AND SYSTEMS SURVEY RELATING TO PAIN
MANAGEMENT.
(a) Restriction on the Use of Pain Questions in HCAHPS.--Section
1886(b)(3)(B)(viii) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(viii)) is amended by adding at the end the following
new subclause:
``(XII)(aa) With respect to a Hospital Consumer Assessment of
Healthcare Providers and Systems survey (or a successor survey)
conducted on or after January 1, 2020, such survey may not include
questions about communication by hospital staff with an individual
about such individual's pain unless such questions take into account,
as applicable, whether an individual experiencing pain was informed
about risks associated with the use of opioids and about non-opioid
alternatives for the treatment of pain.
``(bb) The Secretary shall not include on the Hospital Compare
internet website any measures based on the questions appearing on the
Hospital Consumer Assessment of Healthcare Providers and Systems survey
in 2018 or 2019 about communication by hospital staff with an
individual about such individual's pain.''.
(b) Restriction on Use of 2018 and 2019 Pain Questions in the
Hospital Value-based Purchasing Program.--Section 1886(o)(2)(B) of the
Social Security Act (42 U.S.C. 1395ww(o)(2)(B)) is amended by adding at
the end the following new clause:
``(iii) HCAHPS pain questions.--The Secretary may not
include under subparagraph (A) a measure that is based on
the questions appearing on the Hospital Consumer Assessment
of Healthcare Providers and Systems survey in 2018 or 2019
about communication by hospital staff with an individual
about the individual's pain.''.
Subtitle L--Fighting the Opioid Epidemic With Sunshine
SEC. 6111. FIGHTING THE OPIOID EPIDEMIC WITH SUNSHINE.
(a) Inclusion of Information Regarding Payments to Additional
Practitioners.--
(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.
TITLE VII--PUBLIC HEALTH PROVISIONS
Subtitle A--Awareness and Training
SEC. 7001. REPORT ON EFFECTS ON PUBLIC HEALTH OF SYNTHETIC DRUG USE.
(a) In General.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human Services, in
coordination with the Surgeon General of the Public Health Service,
shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the health effects of new
psychoactive substances, including synthetic drugs, used 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)).
SEC. 7002. 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 use disorder 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''.
Subtitle B--Pilot Program for Public Health Laboratories To Detect
Fentanyl and Other Synthetic Opioids
SEC. 7011. PILOT PROGRAM FOR PUBLIC HEALTH LABORATORIES TO DETECT
FENTANYL AND OTHER SYNTHETIC OPIOIDS.
(a) Grants.--The Secretary of Health and Human Services (referred
to in this section as the ``Secretary'') shall award grants to, or
enter into cooperative agreements with, Federal, State, and local
agencies to improve coordination between public health laboratories and
laboratories operated by law enforcement agencies, such as Customs and
Border Protection and the Drug Enforcement Administration, to improve
detection of synthetic opioids, including fentanyl and its analogues,
as described in subsection (b).
(b) Detection Activities.--The Secretary, in consultation with the
Director of the National Institute of Standards and Technology, the
Director of the Centers for Disease Control and Prevention, the
Attorney General of the United States, and the Administrator of the
Drug Enforcement Administration, shall, for purposes of this section,
develop or identify--
(1) best practices for safely handling and testing synthetic
opioids, including fentanyl and its analogues, including with
respect to reference materials, instrument calibration, and quality
control protocols;
(2) reference materials and quality control standards related
to synthetic opioids, including fentanyl and its analogues, to
enhance--
(A) clinical diagnostics;
(B) postmortem data collection; and
(C) portable testing equipment utilized by law enforcement
and public health officials; and
(3) procedures for the identification of new and emerging
synthetic opioid formulations and procedures for reporting those
findings to appropriate law enforcement agencies and Federal,
State, and local public health laboratories and health departments,
as appropriate.
(c) Laboratories.--The Secretary shall require recipients of grants
or cooperative agreements under subsection (a) to--
(1) follow the best practices established under subsection (b)
and have the appropriate capabilities to provide laboratory testing
of controlled substances, such as synthetic fentanyl, and
biospecimens for the purposes of aggregating and reporting public
health information to Federal, State, and local public health
officials, laboratories, and other entities the Secretary deems
appropriate;
(2) work with law enforcement agencies and public health
authorities, as practicable;
(3) provide early warning information to Federal, State, and
local law enforcement agencies and public health authorities
regarding trends or other data related to the supply of synthetic
opioids, including fentanyl and its analogues;
(4) provide biosurveillance capabilities with respect to
identifying trends in adverse health outcomes associated with non-
fatal exposures; and
(5) provide diagnostic testing, as appropriate and practicable,
for non-fatal exposures of emergency personnel, first responders,
and other individuals.
(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $15,000,000 for each of fiscal
years 2019 through 2023.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
SEC. 7021. ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION
DASHBOARD.
Title XVII of the Public Health Service Act (42 U.S.C. 300u et
seq.) is amended by adding at the end the following new section:
``SEC. 1711. ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION
DASHBOARD.
``(a) In General.--Not later than 6 months after the date of the
enactment of this section, the Secretary of Health and Human Services
shall, in consultation with the Director of National Drug Control
Policy, establish and periodically update, on the Internet website of
the Department of Health and Human Services, a public information
dashboard that--
``(1) provides links to information on programs within the
Department of Health and Human Services related to the reduction of
opioid and other substance use disorders;
``(2) provides access, to the extent practicable and
appropriate, to publicly available data, which may include data
from agencies within the Department of Health and Human Services
and--
``(A) other Federal agencies;
``(B) State, local, and Tribal governments;
``(C) nonprofit organizations;
``(D) law enforcement;
``(E) medical experts;
``(F) public health educators; and
``(G) research institutions regarding prevention,
treatment, recovery, and other services for opioid and other
substance use disorders;
``(3) provides data on substance use disorder prevention and
treatment strategies in different regions of and populations in the
United States;
``(4) identifies information on alternatives to controlled
substances for pain management, such as approaches studied by the
National Institutes of Health Pain Consortium, the National Center
for Complimentary and Integrative Health, and other institutes and
centers at the National Institutes of Health, as appropriate; and
``(5) identifies guidelines and best practices for health care
providers regarding treatment of substance use disorders.
``(b) Controlled Substance Defined.--In this section, the term
`controlled substance' has the meaning given that term in section 102
of the Controlled Substances Act (21 U.S.C. 802).''.
SEC. 7022. INTERDEPARTMENTAL SUBSTANCE USE DISORDERS COORDINATING
COMMITTEE.
(a) Establishment.--Not later than 3 months after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall, in coordination
with the Director of National Drug Control Policy, establish a
committee, to be known as the Interdepartmental Substance Use Disorders
Coordinating Committee (in this section referred to as the
``Committee''), to coordinate Federal activities related to substance
use disorders.
(b) Membership.--
(1) Federal members.--The Committee shall be composed of the
following Federal representatives, or the designees of such
representatives:
(A) The Secretary, who shall serve as the Chair of the
Committee.
(B) The Attorney General of the United States.
(C) The Secretary of Labor.
(D) The Secretary of Housing and Urban Development.
(E) The Secretary of Education.
(F) The Secretary of Veterans Affairs.
(G) The Commissioner of Social Security.
(H) The Assistant Secretary for Mental Health and Substance
Use.
(I) The Director of National Drug Control Policy.
(J) Representatives of other Federal agencies that support
or conduct activities or programs related to substance use
disorders, as determined appropriate by the Secretary.
(2) Non-federal members.--The Committee shall include a minimum
of 15 non-Federal members appointed by the Secretary, of which--
(A) at least two such members shall be an individual who
has received treatment for a diagnosis of a substance use
disorder;
(B) at least two such members shall be a director of a
State substance abuse agency;
(C) at least two such members shall be a representative of
a leading research, advocacy, or service organization for
adults with substance use disorder;
(D) at least two such members shall--
(i) be a physician, licensed mental health
professional, advance practice registered nurse, or
physician assistant; and
(ii) have experience in treating individuals with
substance use disorders;
(E) at least one such member shall be a substance use
disorder treatment professional who provides treatment services
at a certified opioid treatment program;
(F) at least one such member shall be a substance use
disorder treatment professional who has research or clinical
experience in working with racial and ethnic minority
populations;
(G) at least one such member shall be a substance use
disorder treatment professional who has research or clinical
mental health experience in working with medically underserved
populations;
(H) at least one such member shall be a State-certified
substance use disorder peer support specialist;
(I) at least one such member shall be a drug court judge or
a judge with experience in adjudicating cases related to
substance use disorder;
(J) at least one such member shall be a public safety
officer with extensive experience in interacting with adults
with a substance use disorder; and
(K) at least one such member shall be an individual with
experience providing services for homeless individuals with a
substance use disorder.
(c) Terms.--
(1) In general.--A member of the Committee appointed under
subsection (b)(2) shall be appointed for a term of 3 years and may
be reappointed for one or more 3-year terms.
(2) Vacancies.--A vacancy on the Committee shall be filled in
the same manner in which the original appointment was made. Any
individual appointed to fill a vacancy for an unexpired term shall
be appointed for the remainder of such term and may serve after the
expiration of such term until a successor has been appointed.
(d) Meetings.--The Committee shall meet not fewer than two times
each year.
(e) Duties.--The Committee shall--
(1) identify areas for improved coordination of activities, if
any, related to substance use disorders, including research,
services, supports, and prevention activities across all relevant
Federal agencies;
(2) identify and provide to the Secretary recommendations for
improving Federal programs for the prevention and treatment of, and
recovery from, substance use disorders, including by expanding
access to prevention, treatment, and recovery services;
(3) analyze substance use disorder prevention and treatment
strategies in different regions of and populations in the United
States and evaluate the extent to which Federal substance use
disorder prevention and treatment strategies are aligned with State
and local substance use disorder prevention and treatment
strategies;
(4) make recommendations to the Secretary regarding any
appropriate changes with respect to the activities and strategies
described in paragraphs (1) through (3);
(5) make recommendations to the Secretary regarding public
participation in decisions relating to substance use disorders and
the process by which public feedback can be better integrated into
such decisions; and
(6) make recommendations to ensure that substance use disorder
research, services, supports, and prevention activities of the
Department of Health and Human Services and other Federal agencies
are not unnecessarily duplicative.
(f) Annual Report.--Not later than 1 year after the date of the
enactment of this Act, and annually thereafter for the life of the
Committee, the Committee shall publish on the Internet website of the
Department of Health and Human Services, which may include the public
information dashboard established under section 1711 of the Public
Health Service Act, as added by section 7021, a report summarizing the
activities carried out by the Committee pursuant to subsection (e),
including any findings resulting from such activities.
(g) Working Groups.--The Committee may establish working groups for
purposes of carrying out the duties described in subsection (e). Any
such working group shall be composed of members of the Committee (or
the designees of such members) and may hold such meetings as are
necessary to enable the working group to carry out the duties delegated
to the working group.
(h) Federal Advisory Committee Act.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Committee only to the extent
that the provisions of such Act do not conflict with the requirements
of this section.
(i) Sunset.--The Committee shall terminate on the date that is 6
years after the date on which the Committee is established under
subsection (a).
SEC. 7023. 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 of Health and Human Services
(referred to in this section as the ``Secretary''), in coordination
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 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 date
of 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.
SEC. 7024. STUDY ON PRESCRIBING LIMITS.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, in consultation with the
Attorney General of the United States, 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)).
Subtitle D--Ensuring Access to Quality Sober Living
SEC. 7031. NATIONAL RECOVERY HOUSING BEST PRACTICES.
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 new section:
``SEC. 550. NATIONAL RECOVERY HOUSING BEST PRACTICES.
``(a) Best Practices for Operating Recovery Housing.--
``(1) In general.--The Secretary, in consultation with the
individuals and entities specified 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,
the individuals and entities specified in subsection (a)(2) and the
Attorney General of the United States.
``(3) Requirements.--
``(A) Practices for identification and reporting.--In
carrying out the activities described in paragraph (1), 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 paragraph (1), the Secretary shall
identify or develop indicators, which may include indicators
related to--
``(i) unusual billing practices;
``(ii) average lengths of stays;
``(iii) excessive levels of drug testing (in terms of
cost or frequency); and
``(iv) unusually high levels of recidivism.
``(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 of the United States;
``(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 described in
subsections (a) and (b), the Secretary, in consultation with
appropriate individuals and entities described in subsections (a)(2)
and (b)(2), 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.
``(2) The terms `Indian tribe' and `tribal organization' have
the meanings given those terms in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 5304).
``(3) The term `tribally designated housing entity' has the
meaning given that term in section 4 of the Native American Housing
Assistance and Self-Determination Act of 1996 (25 U.S.C. 4103).
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $3,000,000 for the period of
fiscal years 2019 through 2021.''.
Subtitle E--Advancing Cutting Edge Research
SEC. 7041. UNIQUE RESEARCH INITIATIVES.
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. 7042. 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 the 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 and 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 in populations with acute and
chronic pain; 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 Secretary 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.''.
Subtitle F--Jessie's Law
SEC. 7051. INCLUSION OF OPIOID ADDICTION HISTORY IN PATIENT RECORDS.
(a) Best Practices.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
(in this section referred to as 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. 7052. COMMUNICATION WITH FAMILIES DURING EMERGENCIES.
(a) Promoting Awareness of Authorized Disclosures During
Emergencies.--The Secretary of Health and Human Services shall annually
notify health care providers regarding permitted disclosures under
Federal health care privacy law during emergencies, including
overdoses, of certain health information to families, caregivers, and
health care providers.
(b) Use of Material.--For the purposes of carrying out subsection
(a), the Secretary of Health and Human Services may use material
produced under section 7053 of this Act or section 11004 of the 21st
Century Cures Act (42 U.S.C. 1320d-2 note).
SEC. 7053. 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 of Health and
Human Services (in this section referred to as 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--
(1) $4,000,000 for fiscal year 2019;
(2) $2,000,000 for each of fiscal years 2020 and 2021; and
(3) $1,000,000 for each of fiscal years 2022 and 2023.
Subtitle G--Protecting Pregnant Women and Infants
SEC. 7061. REPORT ON ADDRESSING MATERNAL AND INFANT HEALTH IN THE
OPIOID CRISIS.
(a) In General.--Not later than 18 months after the date of the
enactment of this Act, the Secretary of Health and Human Services, in
coordination with the Centers for Disease Control and Prevention, the
National Institutes of Health, the Indian Health Service, and the
Substance Abuse and Mental Health Services Administration, shall
develop 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 a report that includes--
(1) information on opioid, non-opioid, and non-pharmacologic
pain management practices during pregnancy and after pregnancy;
(2) recommendations for increasing public awareness and
education about substance use disorders, including opioid use
disorders, during and after pregnancy, including available
treatment resources in urban and rural areas;
(3) recommendations to prevent, identify, and reduce substance
use disorders, including opioid use disorders, during pregnancy to
improve care for pregnant women with substance use disorders and
their infants; and
(4) an identification of areas in need of further research with
respect to acute and chronic pain management during and after
pregnancy.
(b) No Additional Funds.--No additional funds are authorized to be
appropriated for purposes of carrying out subsection (a).
SEC. 7062. PROTECTING MOMS AND INFANTS.
(a) Report.--
(1) In general.--Not later than 60 days after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as 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, 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. 7063. 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 consultation with relevant stakeholders and in
collaboration with the Director of the Centers for Disease Control
and Prevention, develop educational materials for clinicians to use
with pregnant women for shared decision making regarding pain
management and the prevention of substance use disorders 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, and through
public-private partnerships, encourage education about substance
use disorders for pregnant women and health care providers who
treat pregnant women and babies.''.
SEC. 7064. 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 other 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) additional information or data, as appropriate, on
family health history, medication exposures during pregnancy,
demographic information, such as race, ethnicity, geographic
location, and family history, and other relevant information,
to inform such analysis;'';
(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
``other 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 ``other 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. 7065. PLANS OF SAFE CARE.
(a) In General.--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 is authorized to
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). Section 112(a)(2) shall not apply to the
program authorized under this paragraph.
``(B) Distribution of funds.--
``(i) Reservations.--Of the amounts made available to
carry out subparagraph (A), 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 made available to carry
out subparagraph (A) 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 made available to carry out subparagraph
(A) 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 made
available to carry out subparagraph (A) 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, to
implement the activities under this paragraph;
``(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) if applicable, 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
``(VI) 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 (20
U.S.C. 1431 et seq.) 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 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;
``(dd) improving access to treatment services,
which may be prior to the pregnant woman's delivery
date; and
``(ee) keeping families safely together when it
is in the best interest of the child.
``(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, as required under
section 106(b)(2)(B)(ii);
``(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 established
under section 106(b)(2)(B)(i) 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
other entities (including health professionals, health
facilities, child welfare professionals, juvenile and
family court judges, substance use and mental disorder
treatment programs, early childhood education programs,
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) Assisting states' implementation.--The Secretary
shall use the amount reserved under subparagraph (B)(i)(I) to
provide written guidance and technical assistance to support
States in complying with and implementing this paragraph, which
shall include--
``(i) 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) 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) enhancing States' understanding of
requirements and flexibilities under the law, including
by clarifying key terms;
``(II) addressing state-identified challenges with
developing, implementing, and monitoring plans of safe
care, including those reported under subparagraph
(C)(i)(II);
``(III) 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, while recognizing needs of
different populations and varying community approaches
across States; and
``(IV) helping States improve the long-term safety
and well-being of young children and their families;
``(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) Sunset.--The authority under this paragraph shall
sunset on September 30, 2023.''.
(b) Repeal.--The Abandoned Infants Assistance Act of 1988 (42
U.S.C. 5117aa et seq.) is repealed.
Subtitle H--Substance Use Disorder Treatment Workforce
SEC. 7071. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT
WORKFORCE.
Title VII of the Public Health Service Act is amended--
(1) by redesignating part F as part G; and
(2) by inserting after part E (42 U.S.C. 294n et seq.) the
following:
``PART F--SUBSTANCE USE DISORDER TREATMENT WORKFORCE
``SEC. 781. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER
TREATMENT WORKFORCE.
``(a) In General.--The Secretary, acting through the Administrator
of the Health Resources and Services Administration, shall carry out a
program under which--
``(1) the Secretary enters into agreements with individuals to
make payments in accordance with subsection (b) on the principal of
and interest on any eligible loan; and
``(2) the individuals each agree to the requirements of service
in substance use disorder treatment employment, as described in
subsection (d).
``(b) Payments.--For each year of obligated service by an
individual pursuant to an agreement under subsection (a), the Secretary
shall make a payment to such individual as follows:
``(1) Service in a shortage area.--The Secretary shall pay--
``(A) for each year of obligated service by an individual
pursuant to an agreement under subsection (a), \1/6\ of the
principal of and interest on each eligible loan of the
individual which is outstanding on the date the individual
began service pursuant to the agreement; and
``(B) for completion of the sixth and final year of such
service, the remainder of such principal and interest.
``(2) Maximum amount.--The total amount of payments under this
section to any individual shall not exceed $250,000.
``(c) Eligible Loans.--The loans eligible for repayment under this
section are each of the following:
``(1) Any loan for education or training for a substance use
disorder treatment employment.
``(2) Any loan under part E of title VIII (relating to nursing
student loans).
``(3) Any Federal Direct Stafford Loan, Federal Direct PLUS
Loan, Federal Direct Unsubsidized Stafford Loan, or Federal Direct
Consolidation Loan (as such terms are used in section 455 of the
Higher Education Act of 1965).
``(4) Any Federal Perkins Loan under part E of title I of the
Higher Education Act of 1965.
``(5) Any other Federal loan as determined appropriate by the
Secretary.
``(d) Requirements of Service.--Any individual receiving payments
under this program as required by an agreement under subsection (a)
shall agree to an annual commitment to full-time employment, with no
more than 1 year passing between any 2 years of covered employment, in
substance use disorder treatment employment in the United States in--
``(1) a Mental Health Professional Shortage Area, as designated
under section 332; or
``(2) a county (or a municipality, if not contained within any
county) where the mean drug overdose death rate per 100,000 people
over the past 3 years for which official data is available from the
State, is higher than the most recent available national average
overdose death rate per 100,000 people, as reported by the Centers
for Disease Control and Prevention.
``(e) Ineligibility for Double Benefits.--No borrower may, for the
same service, receive a reduction of loan obligations or a loan
repayment under both--
``(1) this section; and
``(2) any Federally supported loan forgiveness program,
including under section 338B, 338I, or 846 of this Act, or section
428J, 428L, 455(m), or 460 of the Higher Education Act of 1965.
``(f) Breach.--
``(1) Liquidated damages formula.--The Secretary may establish
a liquidated damages formula to be used in the event of a breach of
an agreement entered into under subsection (a).
``(2) Limitation.--The failure by an individual to complete the
full period of service obligated pursuant to such an agreement,
taken alone, shall not constitute a breach of the agreement, so
long as the individual completed in good faith the years of service
for which payments were made to the individual under this section.
``(g) Additional Criteria.--The Secretary--
``(1) may establish such criteria and rules to carry out this
section as the Secretary determines are needed and in addition to
the criteria and rules specified in this section; and
``(2) shall give notice to the committees specified in
subsection (h) of any criteria and rules so established.
``(h) Report to Congress.--Not later than 5 years after the date of
enactment of this section, and every other year thereafter, the
Secretary shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on--
``(1) the number and location of borrowers who have qualified
for loan repayments under this section; and
``(2) the impact of this section on the availability of
substance use disorder treatment employees nationally and in
shortage areas and counties described in subsection (d).
``(i) Definition.--In this section:
``(1) The terms `Indian tribe' and `tribal organization' have
the meanings given those terms in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(2) The term `municipality' means a city, town, or other
public body created by or pursuant to State law, or an Indian
tribe.
``(3) The term `substance use disorder treatment employment'
means full-time employment (including a fellowship)--
``(A) where the primary intent and function of the position
is the direct treatment or recovery support of patients with or
in recovery from a substance use disorder, including master's
level social workers, psychologists, counselors, marriage and
family therapists, psychiatric mental health practitioners,
occupational therapists, psychology doctoral interns, and
behavioral health paraprofessionals and physicians, physician
assistants, and nurses, who are licensed or certified in
accordance with applicable State and Federal laws; and
``(B) which is located at a substance use disorder
treatment program, private physician practice, hospital or
health system-affiliated inpatient treatment center or
outpatient clinic (including an academic medical center-
affiliated treatment program), correctional facility or
program, youth detention center or program, inpatient
psychiatric facility, crisis stabilization unit, community
health center, community mental health or other specialty
community behavioral health center, recovery center, school,
community-based organization, telehealth platform, migrant
health center, health program or facility operated by an Indian
tribe or tribal organization, Federal medical facility, or any
other facility as determined appropriate for purposes of this
section by the Secretary.
``(j) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $25,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7072. CLARIFICATION REGARDING 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. CLARIFICATION REGARDING 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. 7073. 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 of the Public Health Service Act (42 U.S.C. 294e-1) is
amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting ``, trauma,'' after
``focus on child and adolescent mental health''; and
(B) in paragraphs (2) and (3), by inserting ``trauma-
informed care and'' before ``substance use disorder prevention
and treatment services''; and
(2) in subsection (f), by striking ``2018 through 2022'' and
inserting ``2019 through 2023''.
Subtitle I--Preventing Overdoses While in Emergency Rooms
SEC. 7081. PROGRAM TO SUPPORT COORDINATION AND CONTINUATION OF CARE FOR
DRUG OVERDOSE PATIENTS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as 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
a drug overdose; and
(4) the provision or prescribing 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 a
drug 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 substance abuse 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, such as an emergency department, in consultation
with a State substance abuse 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 or devices approved
or cleared under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and all biological products licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262) 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 or devices approved or cleared under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
and all biological products licensed under section 351 of the
Public Health Service Act (42 U.S.C. 262) to treat substance
use disorders or reverse overdose, 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 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))), 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))), or a hospital that receives
disproportionate share hospital payments under section
1886(d)(5)(F) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(F)).
(B) The eligible entity is located in a State 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, 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 through appropriate mechanisms as
determined by the Secretary in consultation with Indian Tribes.
(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) Indian tribe; tribal organization.--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).
(2) 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.
(3) 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)).
(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 $10,000,000 for each of fiscal
years 2019 through 2023.
Subtitle J--Alternatives to Opioids in the Emergency Department
SEC. 7091. EMERGENCY DEPARTMENT ALTERNATIVES TO OPIOIDS DEMONSTRATION
PROGRAM.
(a) Demonstration Program Grants.--
(1) In general.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall carry out a
demonstration program for purposes of awarding grants to hospitals
and emergency departments, including freestanding emergency
departments, to develop, implement, enhance, or study alternatives
to opioids for pain management in such settings.
(2) Eligibility.--To be eligible to receive a grant under
paragraph (1), a hospital or emergency department shall submit an
application to the Secretary at such time, in such manner, and
containing such information as the Secretary may require.
(3) Geographic distribution.--In awarding grants under this
section, the Secretary shall seek to ensure geographical
distribution among grant recipients.
(4) Use of funds.--Grants under paragraph (1) shall be used
to--
(A) target treatment approaches for painful conditions
frequently treated in such settings;
(B) train providers and other hospital personnel on
protocols or best practices related to the use and prescription
of opioids and alternatives to opioids for pain management in
the emergency department; and
(C) develop or continue strategies to provide alternatives
to opioids, as appropriate.
(b) Additional Demonstration Program.--The Secretary may carry out
a demonstration program similar to the program under subsection (a) for
other acute care settings.
(c) Consultation.--The Secretary shall implement a process for
recipients of grants under subsection (a) or (b) to share evidence-
based and best practices and promote consultation with persons having
robust knowledge, including emergency departments and physicians that
have successfully implemented programs that use alternatives to opioids
for pain management, as appropriate, such as approaches studied through
the National Center for Complimentary and Integrative Health or other
institutes and centers at the National Institutes of Health, as
appropriate. The Secretary shall offer to each recipient of a grant
under subsection (a) or (b) technical assistance as necessary.
(d) Technical Assistance.--The Secretary shall identify or
facilitate the development of best practices on alternatives to opioids
for pain management and 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 recipients of a grant under
subsection (a) or (b) that have successfully implemented
alternatives to opioids programs;
(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; and
(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.
(e) Report to the Secretary.--Each recipient of a grant under this
section shall submit to the Secretary (during the period of such grant)
annual reports on the progress of the program funded through the grant.
These reports shall include, in accordance with all applicable State
and Federal privacy laws--
(1) a description of and specific information about the opioid
alternative pain management programs, including the demographic
characteristics of patients who were treated with an alternative
pain management protocol, implemented in hospitals, emergency
departments, and other acute care settings;
(2) data on the opioid alternative pain management strategies
used, including the number of opioid prescriptions written--
(A) during a baseline period before the program began; or
(B) at various stages of the program; and
(3) data on patients who were eventually prescribed opioids
after alternative pain management protocols and treatments were
utilized; and
(4) any other information the Secretary determines appropriate.
(f) Report to Congress.--Not later than 1 year after completion of
the demonstration program under this section, the Secretary shall
submit a report to the Congress on the results of the demonstration
program and include in the report--
(1) the number of applications received and the number funded;
(2) a summary of the reports described in subsection (e),
including data that allows for comparison of programs; and
(3) recommendations for broader implementation of pain
management strategies that encourage the use of alternatives to
opioids in hospitals, emergency departments, or other acute care
settings.
(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2019 through 2021.
Subtitle K--Treatment, Education, and Community Help To Combat
Addiction
SEC. 7101. ESTABLISHMENT OF REGIONAL CENTERS OF EXCELLENCE IN SUBSTANCE
USE DISORDER EDUCATION.
Part D of title V of the Public Health Service Act, as amended by
section 7031, is further amended by adding at the end the following new
section:
``SEC. 551. REGIONAL CENTERS OF EXCELLENCE IN SUBSTANCE USE
DISORDER EDUCATION.
``(a) In General.--The Secretary, in consultation with appropriate
agencies, shall award cooperative agreements to eligible entities for
the designation of such entities as Regional Centers of Excellence in
Substance Use Disorder Education for purposes of improving health
professional training resources with respect to substance use disorder
prevention, treatment, and recovery.
``(b) Eligibility.--To be eligible to receive a cooperative
agreement under subsection (a), an entity shall--
``(1) be an accredited entity that offers education to students
in various health professions, which may include--
``(A) a teaching hospital;
``(B) a medical school;
``(C) a certified behavioral health clinic; or
``(D) any other health professions school, school of public
health, or Cooperative Extension Program at institutions of
higher education, as defined in section 101 of the Higher
Education Act of 1965, engaged in the prevention, treatment, or
recovery of substance use disorders;
``(2) demonstrate community engagement and partnerships with
community stakeholders, including entities that train health
professionals, mental health counselors, social workers, peer
recovery specialists, substance use treatment programs, community
health centers, physician offices, certified behavioral health
clinics, research institutions, and law enforcement; and
``(3) submit to the Secretary an application containing such
information, at such time, and in such manner, as the Secretary may
require.
``(c) Activities.--An entity receiving an award under this section
shall develop, evaluate, and distribute evidence-based resources
regarding the prevention and treatment of, and recovery from, substance
use disorders. Such resources may include information on--
``(1) the neurology and pathology of substance use disorders;
``(2) advancements in the treatment of substance use disorders;
``(3) techniques and best practices to support recovery from
substance use disorders;
``(4) strategies for the prevention and treatment of, and
recovery from substance use disorders across patient populations;
and
``(5) other topic areas that are relevant to the objectives
described in subsection (a).
``(d) Geographic Distribution.--In awarding cooperative agreements
under subsection (a), the Secretary shall take into account regional
differences among eligible entities and shall make an effort to ensure
geographic distribution.
``(e) Evaluation.--The Secretary shall evaluate each project
carried out by an entity receiving an award under this section and
shall disseminate the findings with respect to each such evaluation to
appropriate public and private entities.
``(f) Funding.--There is authorized to be appropriated to carry out
this section, $4,000,000 for each of fiscal years 2019 through 2023.''.
SEC. 7102. 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 of Health and Human Services
(referred to in this section as the ``Secretary'', except as otherwise
provided), in consultation with the Secretary of Education and other
heads of agencies, including the Assistant Secretary for Mental Health
and Substance Use and the Administrator of the Health Resources and
Services Administration, as appropriate, 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) 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).
(C) 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).
(D) 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).
(E) Indian tribe; tribal organization.--The terms ``Indian
tribe'' and ``tribal organization'' have the meanings given
such terms in section 4 of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 5304).
(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 such 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 such 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 (7)(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
disorder prevention, treatment, and recovery 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) 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 served by the grant during the grant period;
and
(iii) other indicators, as the Secretary determines
appropriate.
(8) 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 (7).
(9) Authorization of appropriations.--There is authorized to be
appropriated $10,000,000 to carry out this subsection for each of
fiscal years 2019 through 2023.
Subtitle L--Information From National Mental Health and Substance Use
Policy Laboratory
SEC. 7111. INFORMATION FROM NATIONAL MENTAL HEALTH AND SUBSTANCE USE
POLICY LABORATORY.
Section 501A(b) of the Public Health Service Act (42 U.S.C. 290aa-
0(b)) is amended--
(1) in paragraph (5)(C), by striking ``; and'' at the end and
inserting a semicolon;
(2) by redesignating paragraph (6) as paragraph (7); and
(3) by inserting after paragraph (5) the following:
``(6) issue and periodically update information for entities
applying for grants or cooperative agreements from the Substance
Abuse and Mental Health Services Administration in order to--
``(A) encourage the implementation and replication of
evidence-based practices; and
``(B) provide technical assistance to applicants for
funding, including with respect to justifications for such
programs and activities; and''.
Subtitle M--Comprehensive Opioid Recovery Centers
SEC. 7121. COMPREHENSIVE OPIOID RECOVERY CENTERS.
(a) In General.--Part D of title V of the Public Health Service Act
(42 U.S.C. 290dd et seq.), as amended by sections 7031 and 7101, is
further amended by adding at the end the following new section:
``SEC. 552. 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 of not less than 3 years and 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 Centers.--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--
``(1) located in a State 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; or
``(2) serving an Indian Tribe (as defined in section 4 of the
Indian Self-Determination and Education Assistance Act) with an
age-adjusted rate of drug overdose deaths that is above the
national overdose mortality rate, as determined through appropriate
mechanisms determined by the Secretary in consultation with Indian
Tribes.
``(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, evaluations, and periodic patient
assessments meet the individualized clinical needs of patients,
including by reviewing patient placement in treatment settings
to support meaningful recovery.
``(B) Provide the full continuum of treatment services,
including--
``(i) all drugs and devices approved or cleared under
the Federal Food, Drug, and Cosmetic Act and all biological
products licensed under section 351 of this Act to treat
substance use disorders or reverse overdoses, 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) Provide onsite access to medication, as appropriate,
and toxicology services; for purposes of carrying out this
section.
``(F) Operate a secure, confidential, and interoperable
electronic health information system.
``(G) Offer family support services such as child care,
family counseling, and parenting interventions to help
stabilize families impacted by substance use disorder, as
appropriate.
``(2) Outreach.--Each Center shall carry out outreach
activities regarding 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.''.
(b) Reports to Congress.--
(1) Preliminary report.--Not later than 3 years after the date
of the enactment of this Act, the Secretary of Health and Human
Services shall submit to Congress a preliminary report that
analyzes data submitted under section 552(h) of the Public Health
Service Act, as added by subsection (a).
(2) Final report.--Not later than 2 years after submitting the
preliminary report required under paragraph (1), the Secretary of
Health and Human Services 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 section 552 of the Public Health Service Act, as
added by subsection (a), 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.
Subtitle N--Trauma-Informed Care
SEC. 7131. 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
biennially.
(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 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 (as defined in section 4 of the Indian Self-Determination
and Education Assistance Act) 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 $2,000,000 for each of fiscal
years 2019 through 2023.
SEC. 7132. 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--
(1) best practices with respect to children and youth, and
their families as appropriate, who have experienced or are at risk
of experiencing trauma; and
(2) ways in which Federal agencies can better coordinate to
improve the Federal response to families impacted by substance use
disorders and other forms of 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 of the Department of
Health and Human Services.
(L) The Administration for Children and Families.
(M) The Office of the Assistant Secretary for Planning and
Evaluation of the Department of Health and Human Services.
(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 60 days 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, or the
Assistant Secretary's designee.
(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) prevention strategies for individuals at risk of
experiencing or being exposed to trauma, including trauma
as a result of exposure to substance use;
(ii) the identification of infants, children and youth,
and their families as appropriate, who have experienced or
are at risk of experiencing trauma;
(iii) the expeditious referral to and implementation of
trauma-informed practices and supports that prevent and
mitigate the effects of trauma, which may include whole-
family and multi-generational approaches; and
(iv) community based or multi-generational practices
that support children and their families;
(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--
(i) data sharing;
(ii) providing support to infants, children, and youth,
and their families as appropriate, who have experienced or
are at risk of experiencing trauma;
(iii) identifying options for coordinating existing
grants that support infants, children, and youth, and their
families as appropriate, who have experienced, or are at
risk of experiencing, exposure to substance use or other
trauma, including trauma related to substance use; and
(iv) other ways to improve coordination, planning, and
communication within and across Federal agencies, offices,
and programs, to better serve children and families
impacted by substance use disorders; 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
and education 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
and services;
(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 and 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 other health care providers with
expertise in providing support services and 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 outcomes and improve processes for trauma-informed
services and supports that are culturally sensitive,
linguistically appropriate, and specific to age ranges and
sex, as applicable;
(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; and
(3) recommend opportunities for local- and State-level
partnerships that--
(A) are designed to quickly identify and refer children and
families, as appropriate, who have experienced or are at risk
of experiencing exposure to trauma, including related to
substance use;
(B) utilize and develop partnerships with early childhood
education programs, local social services organizations, and
health care services aimed at preventing or mitigating the
effects of exposure to trauma, including related to substance
use;
(C) offer community-based prevention activities, including
educating families and children on the effects of exposure to
trauma, such as trauma related to substance use, and how to
build resilience and coping skills to mitigate those effects;
(D) in accordance with Federal privacy protections, utilize
non-personally-identifiable data from screenings, referrals, or
the provision of services and supports to evaluate and improve
processes addressing exposure to trauma, including related to
substance use; and
(E) are designed to prevent separation and support
reunification of families if in the best interest of the child.
(e) Operating Plan.--Not later than 120 days 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;
(6) a proposed timeline for implementing recommendations and
efforts identified under subsection (c); and
(7) other information that the task force determines
appropriate as related to its duties.
(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, other relevant cabinet Secretaries, the Committee on Energy
and Commerce and the Committee on Education and the Workforce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate, and Congress, a final report containing all
of the findings and recommendations required under this section, and
shall make such report available online in an accessible format.
(g) Additional Reports.--In addition to the final report under
subsection (f). the task force shall submit--
(1) a report to Congress identifying any recommendations
identified under subsection (c) that require additional legislative
authority to implement; and
(2) a report to the Governors describing the opportunities for
local- and State-level partnerships, professional development, or
best practices recommended under subsection (d)(3).
(h) Definitions.--In this section--
(1) 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);
(2) The term ``Governor'' means the chief executive officer of
a State; and
(3) the term ``State'' means each of the several States, the
District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, Guam, American Samoa, and the Commonwealth of the Northern
Mariana Islands.
(i) Sunset.--The task force shall sunset on the date that is 60
days after the submission of the final report under subsection (f), but
not later than September 30, 2023.
SEC. 7133. 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 ``$63,887,000 for each of fiscal years 2019 through 2023''.
SEC. 7134. 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, Indian Tribes (as defined in
section 4 of the Indian Self-Determination and Education Assistance
Act) or their tribal educational agencies, a school operated by the
Bureau of Indian Education, a Regional Corporation, or a Native
Hawaiian educational organization, 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 providing
trauma screenings to identify students in need of specialized
support.
(2) To implement schoolwide 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 for trauma-informed
identification, referral, and support developed by the Task
Force under section 7132.
(4) Services at a full-service community school that focuses on
trauma-informed supports, which may include 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.
(8) To establish partnerships with or provide subgrants to Head
Start agencies (including Early Head Start agencies), public and
private preschool programs, child care programs (including home-
based providers), or other entities described in subsection (a), to
include such entities described in this paragraph in the evidence-
based trauma initiatives, activities, support services, and mental
health systems established under this section in order to provide,
develop, or improve prevention, screening, referral, and treatment
and support services to young children and their families.
(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.
(6) A description of the entities in the community with which
the applicant will partner or to which the applicant will provide
subgrants in accordance with subsection (c)(8).
(e) Interagency Agreements.--
(1) Local interagency agreements.--To ensure the provision of
the services described in subsection (c), a recipient of a grant,
contract, or cooperative agreement under this section, or their
designee, shall establish a local interagency agreement among local
educational agencies, agencies responsible for early childhood
education programs, Head Start agencies (including Early Head Start
agencies), juvenile justice authorities, mental health agencies,
child welfare agencies, and other relevant agencies, authorities,
or entities in the community that will be involved in the provision
of such services.
(2) Contents.--In ensuring the provision of the services
described in subsection (c), the local interagency agreement shall
specify with respect to each agency, authority, or entity that is a
party to such agreement--
(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 such
agencies, authorities, or entities, including procedures for
dispute resolution.
(f) Evaluation.--The Secretary shall reserve not more than 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 with
Indian Tribes and their representatives to ensure notice of
eligibility.
(k) Definitions.--In this section:
(1) Elementary school.--The term ``elementary school'' has the
meaning given such term 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) Local educational agency.--The term ``local educational
agency'' has the meaning given such term in section 8101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(5) Regional corporation.--The term ``Regional Corporation''
has the meaning given the term in section 3 of the Alaska Native
Claims Settlement Act (43 U.S.C. 1602)).
(6) School.--The term ``school'' means a public elementary
school or public secondary school.
(7) 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).
(8) Secondary school.--The term ``secondary school'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(9) Secretary.--The term ``Secretary'' means the Secretary of
Education.
(10) 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).
(11) State educational agency.--The term ``State educational
agency'' 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, $50,000,000 for each of fiscal
years 2019 through 2023.
SEC. 7135. RECOGNIZING EARLY CHILDHOOD TRAUMA RELATED TO SUBSTANCE
ABUSE.
(a) Dissemination of Information.--The Secretary of Health and
Human Services shall disseminate information, resources, and, if
requested, technical assistance to early childhood care and education
providers and professionals working with young children on--
(1) ways to properly recognize children who may be impacted by
trauma, including trauma related to substance use by a family
member or other adult; and
(2) how to respond appropriately in order to provide for the
safety and well-being of young children and their families.
(b) Goals.--The information, resources, and technical assistance
provided under subsection (a) shall--
(1) educate early childhood care and education providers and
professionals working with young children on understanding and
identifying the early signs and risk factors of children who might
be impacted by trauma, including trauma due to exposure to
substance use;
(2) suggest age-appropriate communication tools, procedures,
and practices for trauma-informed care, including ways to prevent
or mitigate the effects of trauma;
(3) provide options for responding to children impacted by
trauma, including due to exposure to substance use, that consider
the needs of the child and family, including recommending resources
and referrals for evidence-based services to support such family;
and
(4) promote whole-family and multi-generational approaches to
keep families safely together when it is in the best interest of
the child.
(c) Coordination.--The Secretary of Health and Human Services shall
coordinate with the task force to develop best practices for trauma-
informed identification, referral, and support authorized under section
7132 in disseminating the information, resources, and technical
assistance described under subsection (b).
(d) Rule of Construction.--Such information, resources, and if
applicable, technical assistance, shall not be construed to amend the
requirements under--
(1) the Child Care and Development Block Grant Act of 1990 (42
U.S.C. 9858 et seq.);
(2) the Head Start Act (42 U.S.C. 9831 et seq.); or
(3) the Individuals with Disabilities Education Act (20 U.S.C.
1400 et seq.).
Subtitle O--Eliminating Opioid Related Infectious Diseases
SEC. 7141. REAUTHORIZATION AND EXPANSION OF PROGRAM OF 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 to read as follows:
``SEC. 317N. SURVEILLANCE AND EDUCATION REGARDING INFECTIONS ASSOCIATED
WITH ILLICIT DRUG USE AND OTHER RISK FACTORS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may (directly or
through grants to public and nonprofit private entities) provide for
programs for the following:
``(1) To cooperate with States and Indian tribes in
implementing or maintaining a national system to determine the
incidence of infections commonly associated with illicit drug use,
such as viral hepatitis, human immunodeficiency virus, and
infective endocarditis, and to assist the States in determining the
prevalence of such infections, which may include the reporting of
cases of such infections.
``(2) To identify, counsel, and offer testing to individuals
who are at risk of infections described in paragraph (1) resulting
from illicit drug use, receiving blood transfusions prior to July
1992, or other risk factors.
``(3) To provide appropriate referrals for counseling, testing,
and medical treatment of individuals identified under paragraph (2)
and to ensure, to the extent practicable, the provision of
appropriate follow-up services.
``(4) To develop and disseminate public information and
education programs for the detection and control of infections
described in paragraph (1), with priority given to high-risk
populations as determined by the Secretary.
``(5) To improve the education, training, and skills of health
professionals in the detection and control of infections described
in paragraph (1), including to improve coordination of treatment of
substance use disorders and infectious diseases, with priority
given to substance use disorder treatment providers, pediatricians
and other primary care providers, obstetrician-gynecologists, and
infectious disease clinicians, including HIV clinicians.
``(b) Laboratory Procedures.--The Secretary may (directly or
through grants to public and nonprofit private entities) carry out
programs to provide for improvements in the quality of clinical-
laboratory procedures regarding infections described in subsection
(a)(1).
``(c) Definition.--In this section, the term `Indian tribe' has the
meaning given that term in section 4 of the Indian Self-Determination
and Education Assistance Act.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $40,000,000
for each of the fiscal years 2019 through 2023.''.
Subtitle P--Peer Support Communities of Recovery
SEC. 7151. 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 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. 7152. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.
Title V of the Public Health Service Act (42 U.S.C. 290dd et seq.)
is amended by inserting after section 547 the following:
``SEC. 547A. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.
``(a) Establishment.--The Secretary, acting through the Assistant
Secretary, shall establish or operate a National Peer-Run Training and
Technical Assistance Center for Addiction Recovery Support (referred to
in this section 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.
``(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.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $1,000,000 for each of fiscal
years 2019 through 2023.''.
Subtitle Q--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
SEC. 7161. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
(a) In General.--Part J of title III of the Public Health Service
Act (42 U.S.C. 280b et seq.) is amended by inserting after section 392
(42 U.S.C. 280b-1) the following:
``SEC. 392A. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
``(a) Evidence-Based Prevention Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out and expand any
evidence-based prevention activities described in paragraph
(2);
``(B) provide training and technical assistance to States,
localities, and Indian tribes for purposes of carrying out such
activity; and
``(C) award grants to States, localities, and Indian tribes
for purposes of carrying out such activity.
``(2) Evidence-based prevention activities.--An evidence-based
prevention activity described in this paragraph is any of the
following activities:
``(A) Improving the efficiency and use of a new or
currently operating prescription drug monitoring program,
including by--
``(i) encouraging all authorized users (as specified by
the State or other entity) to register with and use the
program;
``(ii) enabling such users to access any updates to
information collected by the program in as close to real-
time as possible;
``(iii) improving the ease of use of such program;
``(iv) 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;
``(v) 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 substance abuse 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;
``(vi) enhancing interoperability between the program
and any health information technology (including certified
health information technology), including by integrating
program data into such technology;
``(vii) updating program capabilities to respond to
technological innovation for purposes of appropriately
addressing the occurrence and evolution of controlled
substance overdoses;
``(viii) facilitating and encouraging data exchange
between the program and the prescription drug monitoring
programs of other States;
``(ix) enhancing data collection and quality, including
improving patient matching and proactively monitoring data
quality;
``(x) providing prescriber and dispenser practice
tools, including prescriber practice insight reports for
practitioners to review their prescribing patterns in
comparison to such patterns of other practitioners in the
specialty; and
``(xi) meeting the purpose of the program established
under section 399O, as described in section 399O(a).
``(B) Promoting community or health system interventions.
``(C) Evaluating interventions to prevent controlled
substance overdoses.
``(D) Implementing projects to advance an innovative
prevention approach with respect to new and emerging public
health crises and opportunities to address such crises, such as
enhancing public education and awareness on the risks
associated with opioids.
``(3) Additional grants.--The Director may award grants to
States, localities, and Indian Tribes--
``(A) 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
``(B) for any other evidence-based activity for preventing
controlled substance misuse, abuse, and overdoses as the
Director determines appropriate.
``(4) 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.
``(b) Enhanced Controlled Substance Overdose Data Collection,
Analysis, and Dissemination Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any controlled
substance overdose data collection activities described in
paragraph (2);
``(B) provide training and technical assistance to States,
localities, and Indian tribes for purposes of carrying out such
activity;
``(C) award grants to States, localities, and Indian tribes
for purposes of carrying out such activity; and
``(D) coordinate with the Assistant Secretary for Mental
Health and Substance Use to collect data pursuant to section
505(d)(1)(A) (relating to the number of individuals admitted to
emergency departments as a result of the abuse of alcohol or
other drugs).
``(2) Controlled substance overdose data collection and
analysis activities.--A controlled substance overdose data
collection, analysis, and dissemination activity described in this
paragraph is any of the following activities:
``(A) Improving the timeliness of reporting data to the
public, including data on fatal and nonfatal overdoses of
controlled substances.
``(B) 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
departments.
``(C) Modernizing the system for coding causes of death
related to controlled substance overdoses to use an electronic-
based system.
``(D) Using data to help identify risk factors associated
with controlled substance overdoses.
``(E) Supporting entities involved in providing information
on controlled substance overdoses, such as coroners, medical
examiners, and public health laboratories to improve accurate
testing and standardized reporting of causes and contributing
factors to controlled substances overdoses and analysis of
various opioid analogues to controlled substance overdoses.
``(F) Working to enable and encourage the access, exchange,
and use of information regarding controlled substance overdoses
among data sources and entities.
``(c) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled substance'
has the meaning given that term in section 102 of the Controlled
Substances Act.
``(2) Indian tribe.--The term `Indian tribe' has the meaning
given that term in section 4 of the Indian Self-Determination and
Education Assistance Act.
``(d) Authorization of Appropriations.--For purposes of carrying
out this section, section 399O of this Act, and section 102 of the
Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-198),
there is authorized to be appropriated $496,000,000 for each of fiscal
years 2019 through 2023.''.
(b) Education and Awareness.--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--
``(A) generally; and
``(B) regarding such risks related to unused opioids and
the dispensing options under section 309(f) of the Controlled
Substances Act, as applicable; and
``(2) 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
``(3) 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. 7162. PRESCRIPTION DRUG MONITORING PROGRAM.
Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is
amended to read as follows:
``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.
``(a) Program.--
``(1) In general.--Each fiscal year, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, in coordination with the heads of other departments and
agencies as appropriate, shall support States or localities for the
purpose of improving the efficiency and use of PDMPs, including--
``(A) establishment and implementation of a PDMP;
``(B) maintenance of a PDMP;
``(C) improvements to a PDMP by--
``(i) enhancing functional components to work toward--
``(I) universal use of PDMPs among providers and
their delegates, to the extent that State laws allow;
``(II) more timely inclusion of data within a PDMP;
``(III) active management of the PDMP, in part by
sending proactive or unsolicited reports to providers
to inform prescribing; and
``(IV) ensuring the highest level of ease in use of
and access to PDMPs by providers and their delegates,
to the extent that State laws allow;
``(ii) in consultation with the Office of the National
Coordinator for Health Information Technology, improving
the intrastate interoperability of PDMPs by--
``(I) making PDMPs more actionable by integrating
PDMPs within electronic health records and health
information technology infrastructure; and
``(II) linking PDMP data to other data systems
within the State, including--
``(aa) the data of pharmacy benefit managers,
medical examiners and coroners, and the State's
Medicaid program;
``(bb) worker's compensation data; and
``(cc) prescribing data of providers of the
Department of Veterans Affairs and the Indian
Health Service within the State;
``(iii) in consultation with the Office of the National
Coordinator for Health Information Technology, improving
the interstate interoperability of PDMPs through--
``(I) sharing of dispensing data in near-real time
across State lines; and
``(II) integration of automated queries for
multistate PDMP data and analytics into clinical
workflow to improve the use of such data and analytics
by practitioners and dispensers; or
``(iv) improving the ability to include treatment
availability resources and referral capabilities within the
PDMP.
``(2) Legislation.--As a condition on the receipt of support
under this section, the Secretary shall require a State or locality
to demonstrate that it has enacted legislation or regulations--
``(A) to provide for the implementation of the PDMP; and
``(B) to permit the imposition of appropriate penalties for
the unauthorized use and disclosure of information maintained
by the PDMP.
``(b) PDMP Strategies.--The Secretary shall encourage a State or
locality, in establishing, improving, or maintaining a PDMP, to
implement strategies that improve--
``(1) the reporting of dispensing in the State or locality of a
controlled substance to an ultimate user so the reporting occurs
not later than 24 hours after the dispensing event;
``(2) the consultation of the PDMP by each prescribing
practitioner, or their designee, in the State or locality before
initiating treatment with a controlled substance, or any substance
as required by the State to be reported to the PDMP, and over the
course of ongoing treatment for each prescribing event;
``(3) the consultation of the PDMP before dispensing a
controlled substance, or any substance as required by the State to
be reported to the PDMP;
``(4) the proactive notification to a practitioner when
patterns indicative of controlled substance misuse by a patient,
including opioid misuse, are detected;
``(5) the availability of data in the PDMP to other States, as
allowable under State law; and
``(6) the availability of nonidentifiable information to the
Centers for Disease Control and Prevention for surveillance,
epidemiology, statistical research, or educational purposes.
``(c) Drug Misuse and Abuse.--In consultation with practitioners,
dispensers, and other relevant and interested stakeholders, a State
receiving support under this section--
``(1) shall establish a program to notify practitioners and
dispensers of information that will help to identify and prevent
the unlawful diversion or misuse of controlled substances;
``(2) may, to the extent permitted under State law, notify the
appropriate authorities responsible for carrying out drug diversion
investigations if the State determines that information in the PDMP
maintained by the State indicates an unlawful diversion or abuse of
a controlled substance;
``(3) 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
``(4) 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.
``(d) Evaluation and Reporting.--As a condition on receipt of
support under this section, the State shall report on interoperability
with PDMPs of other States and Federal agencies, where appropriate,
intrastate interoperability with health information technology systems
such as electronic health records, health information exchanges, and e-
prescribing, where appropriate, and whether or not the State provides
automatic, up-to-date, or daily information about a patient when a
practitioner (or the designee of a practitioner, where permitted)
requests information about such patient.
``(e) Evaluation and Reporting.--A State receiving support under
this section shall provide the Secretary with aggregate nonidentifiable
information, as permitted by State law, to enable the Secretary--
``(1) to evaluate the success of the State's program in
achieving the purpose described in subsection (a); or
``(2) to prepare and submit to the Congress the report required
by subsection (i)(2).
``(f) Education and Access to the Monitoring System.--A State
receiving support under this section shall take steps to--
``(1) facilitate prescribers and dispensers, and their
delegates, as permitted by State law, to use the PDMP, to the
extent practicable; and
``(2) educate prescribers and dispensers, and their delegates
on the benefits of the use of PDMPs.
``(g) Electronic Format.--The Secretary may issue guidelines
specifying a uniform electronic format for the reporting, sharing, and
disclosure of information pursuant to PDMPs. To the extent possible,
such guidelines shall be consistent with standards recognized by the
Office of the National Coordinator for Health Information Technology.
``(h) Rules of Construction.--
``(1) Functions otherwise authorized by law.--Nothing in this
section shall be construed to restrict the ability of any
authority, including any local, State, or Federal law enforcement,
narcotics control, licensure, disciplinary, or program authority,
to perform functions otherwise authorized by law.
``(2) Additional privacy protections.--Nothing in this section
shall be construed as preempting any State from imposing any
additional privacy protections.
``(3) Federal privacy requirements.--Nothing in this section
shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat. 2033) and
section 543 of this Act.
``(4) No federal private cause of action.--Nothing in this
section shall be construed to create a Federal private cause of
action.
``(i) Progress Report.--Not later than 3 years after the date of
enactment of this section, the Secretary shall--
``(1) complete a study that--
``(A) determines the progress of grantees in establishing
and implementing PDMPs consistent with this section;
``(B) provides an analysis of the extent to which the
operation of PDMPs has--
``(i) reduced inappropriate use, abuse, diversion of,
and overdose with, controlled substances;
``(ii) established or strengthened initiatives to
ensure linkages to substance use disorder treatment
services; or
``(iii) affected patient access to appropriate care in
States operating PDMPs;
``(C) determine the progress of grantees in achieving
interstate interoperability and intrastate interoperability of
PDMPs, including an assessment of technical, legal, and
financial barriers to such progress and recommendations for
addressing these barriers;
``(D) determines the progress of grantees in implementing
near real-time electronic PDMPs;
``(E) provides an analysis of the privacy protections in
place for the information reported to the PDMP in each State or
locality receiving support under this section and any
recommendations of the Secretary for additional Federal or
State requirements for protection of this information;
``(F) determines the progress of States or localities in
implementing technological alternatives to centralized data
storage, such as peer-to-peer file sharing or data pointer
systems, in PDMPs and the potential for such alternatives to
enhance the privacy and security of individually identifiable
data; and
``(G) evaluates the penalties that States or localities
have enacted for the unauthorized use and disclosure of
information maintained in PDMPs, and the criteria used by the
Secretary to determine whether such penalties qualify as
appropriate for purposes of subsection (a)(2); and
``(2) submit a report to the Congress on the results of the
study.
``(j) Advisory Council.--
``(1) Establishment.--A State or locality may establish an
advisory council to assist in the establishment, improvement, or
maintenance of a PDMP consistent with this section.
``(2) Limitation.--A State or locality may not use Federal
funds for the operations of an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP.
``(3) Sense of congress.--It is the sense of the Congress that,
in establishing an advisory council to assist in the establishment,
improvement, or maintenance of a PDMP, a State or locality should
consult with appropriate professional boards and other interested
parties.
``(k) Definitions.--For purposes of this section:
``(1) The term `controlled substance' means a controlled
substance (as defined in section 102 of the Controlled Substances
Act) in schedule II, III, or IV of section 202 of such Act.
``(2) The term `dispense' means to deliver a controlled
substance to an ultimate user by, or pursuant to the lawful order
of, a practitioner, irrespective of whether the dispenser uses the
Internet or other means to effect such delivery.
``(3) The term `dispenser' means a physician, pharmacist, or
other person that dispenses a controlled substance to an ultimate
user.
``(4) The term `interstate interoperability' with respect to a
PDMP means the ability of the PDMP to electronically share reported
information with another State if the information concerns either
the dispensing of a controlled substance to an ultimate user who
resides in such other State, or the dispensing of a controlled
substance prescribed by a practitioner whose principal place of
business is located in such other State.
``(5) The term `intrastate interoperability' with respect to a
PDMP means the integration of PDMP data within electronic health
records and health information technology infrastructure or linking
of a PDMP to other data systems within the State, including the
State's Medicaid program, workers' compensation programs, and
medical examiners or coroners.
``(6) The term `nonidentifiable information' means information
that does not identify a practitioner, dispenser, or an ultimate
user and with respect to which there is no reasonable basis to
believe that the information can be used to identify a
practitioner, dispenser, or an ultimate user.
``(7) The term `PDMP' means a prescription drug monitoring
program that is State-controlled.
``(8) The term `practitioner' means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which the individual practices or
does research, to distribute, dispense, conduct research with
respect to, administer, or use in teaching or chemical analysis, a
controlled substance in the course of professional practice or
research.
``(9) The term `State' means each of the 50 States, the
District of Columbia, and any commonwealth or territory of the
United States.
``(10) The term `ultimate user' means a person who has obtained
from a dispenser, and who possesses, a controlled substance for the
person's own use, for the use of a member of the person's
household, or for the use of an animal owned by the person or by a
member of the person's household.
``(11) The term `clinical workflow' means the integration of
automated queries for prescription drug monitoring programs data
and analytics into health information technologies such as
electronic health record systems, health information exchanges,
and/or pharmacy dispensing software systems, thus streamlining
provider access through automated queries.''.
Subtitle R--Review of Substance Use Disorder Treatment Providers
Receiving Federal Funding
SEC. 7171. REVIEW OF SUBSTANCE USE DISORDER TREATMENT PROVIDERS
RECEIVING FEDERAL FUNDING.
(a) In General.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall conduct a review
of entities that receive Federal funding for the provision of substance
use disorder treatment services. The review shall include:
(1) The length of time the entity has provided substance use
disorder treatment services and the geographic area served by the
entity.
(2) A detailed analysis of the patient population served by the
entity, including but not limited to the number of patients, types
of diagnosed substance use disorders and the demographic
information of such patients, including sex, race, ethnicity, and
socioeconomic status.
(3) Detailed information on the types of substance use
disorders for which the entity has the experience, capability, and
capacity to provide such services.
(4) An analysis of how the entity handles patients requiring
treatment for a substance use disorder that the organization is not
able to treat.
(5) An analysis of what is needed in order to improve the
entity's ability to meet the addiction treatment needs of the
communities served by that entity.
(6) Based on the identified needs of the communities served, a
description of unmet needs and inadequate services and how such
needs and services could be better addressed to treat individuals
with methamphetamine, cocaine, including crack cocaine, heroin,
opioid, and other substance use disorders.
(b) Report.--Not later than 2 years after the date of the enactment
of this Act, the Secretary shall develop and submit to Congress a plan
to direct appropriate resources to entities that provide substance use
disorder treatment services in order to address inadequacies in
services or funding identified through the survey described in
subsection (a).
Subtitle S--Other Health Provisions
SEC. 7181. 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
tribal'' 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''; and
(B) in paragraph (2)--
(i) in the matter preceding subparagraph (A), by
striking ``to a State'';
(ii) in subparagraph (A), by striking ``Improving
State'' and inserting ``Establishing or improving'';
(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 or
Indian Tribe, 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 this
subsection, 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''.
SEC. 7182. 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)--
(A) by striking ``with findings of any serious violation
regarding'' and inserting ``concerning''; and
(B) by inserting ``and the Committee on Education and the
Workforce'' after ``Energy and Commerce''; 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.
SEC. 7183. CAREER ACT.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in consultation
with the Secretary of Labor, shall continue or establish a program to
support individuals in substance use disorder treatment and recovery to
live independently and participate in 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 substance
use disorder treatment and recovery to live independently and
participate in 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.--
(1) In general.--In awarding grants under this section, the
Secretary shall give priority based on the State in which the
entity is located. Priority shall be given among States according
to a formula based on the rates described in paragraph (2) and
weighted as described in paragraph (3).
(2) Rates.--The rates described in this paragraph are the
following:
(A) The amount by which the rate of drug overdose deaths in
the State, adjusted for age, is above the national overdose
mortality rate, as determined by the Director of the Centers
for Disease Control and Prevention.
(B) The amount by which the rate of unemployment for the
State, based on data provided by the Bureau of Labor Statistics
for the preceding 5 calendar years for which there is available
data, is above the national average.
(C) The amount by which rate of labor force participation
in the State, based on data provided by the Bureau of Labor
Statistics for the preceding 5 calendar years for which there
is available data, is below the national average.
(3) Weighting.--The rates described in paragraph (2) shall be
weighted as follows:
(A) The rate described in paragraph (2)(A) shall be
weighted 70 percent.
(B) The rate described in paragraph (2)(B) shall be
weighted 15 percent.
(C) The rate described in paragraph (2)(C) shall be
weighted 15 percent.
(d) Preference.--In awarding grants under this section, the
Secretary shall give preference to entities located in areas within
States with the greatest need, with such need based on the highest
mortality rate related to substance use disorder.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means an
entity that offers treatment or recovery services for individuals
with substance use disorders, and partners with one or more local
or State stakeholders, which may include local employers, community
organizations, the local workforce development board, local and
State governments, and Indian Tribes or tribal organizations, to
support recovery, independent living, and participation in the
workforce.
(2) Indian tribes; tribal organization.--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).
(3) State.--The term ``State'' includes only the several States
and the District of Columbia.
(f) 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, local
and State governments, and Indian Tribes or tribal organizations, as
applicable, 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 8041,
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.
(g) 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 and strengthening 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.
(h) Support for State Strategy.--An eligible entity shall include
in its application under subsection (f) 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.
(i) Data Reporting and Program Oversight.--Each eligible entity
awarded a grant under this section shall submit to the Secretary a
report at such time and in such manner as the Secretary may require.
Such report shall include a description of--
(1) the programs and activities funded by the grant;
(2) outcomes of the population of individuals with a substance
use disorder the grantee served through activities described in
subsection (g); and
(3) any other information that the Secretary may require for
the purpose of ensuring that the grantee is complying with all of
the requirements of the grant.
(j) Reports to Congress.--
(1) Preliminary report.--Not later than 2 years after the end
of the first year of the grant period under this section, the
Secretary shall submit to Congress a preliminary report that
analyzes reports submitted under subsection (i).
(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) a description of how the grant funding was used,
including the number of individuals who received services under
subsection (g)(3) and an evaluation of the effectiveness of the
activities conducted by the grantee with respect to outcomes of
the population of individuals with substance use disorder who
receive services from the grantee; and
(B) recommendations related to best practices for health
care professionals to support individuals in substance use
disorder treatment or recovery to live independently and
participate in the workforce.
(k) 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.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
SEC. 8001. SHORT TITLE.
This subtitle may be cited as the ``Synthetics Trafficking and
Overdose Prevention Act of 2018'' or ``STOP Act of 2018''.
SEC. 8002. 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. 8003. 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 shipments.
``(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
1 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 8002, 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. 8004. 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 8003(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 8003(a)(1), the Secretary of State should
expeditiously conclude such an agreement.
SEC. 8005. 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. 8006. 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. 8007. 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. 8008. 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 8007, 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. 8009. EFFECTIVE DATE; REGULATIONS.
(a) Effective Date.--This subtitle and the amendments made by this
subtitle (other than the amendments made by section 8002) shall take
effect on the date of the enactment of this Act.
(b) Regulations.--Not later than 1 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.
Subtitle B--Opioid Addiction Recovery Fraud Prevention
SEC. 8021. SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction Recovery Fraud
Prevention Act of 2018''.
SEC. 8022. DEFINITIONS.
For purposes of this subtitle only, and not be construed or applied
as to challenge or affect the characterization, definition, or
treatment under any other statute, regulation, or rule:
(1) Substance use disorder treatment product.--The term
``substance use disorder treatment product'' means a product for
use or marketed for use in the treatment, cure, or prevention of a
substance use disorder, including an opioid use disorder.
(2) Substance use disorder treatment service.--The term
``substance use disorder treatment service'' means a service that
purports to provide referrals to treatment, treatment, or recovery
housing for people diagnosed with, having, or purporting to have a
substance use disorder, including an opioid use disorder.
SEC. 8023. UNFAIR OR DECEPTIVE ACTS OR PRACTICES WITH RESPECT TO
SUBSTANCE USE DISORDER TREATMENT SERVICE AND PRODUCTS.
(a) Unlawful Activity.--It is unlawful to engage in an unfair or
deceptive act or practice with respect to any substance use disorder
treatment service or substance use disorder 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) Authority Preserved.--Nothing in this subtitle shall be
construed to limit the authority of the Federal Trade Commission or the
Food and Drug Administration under any other provision of law.
Subtitle C--Addressing Economic and Workforce Impacts of the Opioid
Crisis
SEC. 8041. 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 2019 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.
Subtitle D--Peer Support Counseling Program for Women Veterans
SEC. 8051. PEER SUPPORT COUNSELING PROGRAM FOR WOMEN VETERANS.
(a) In General.--Section 1720F(j) of title 38, United States Code,
is amended by adding at the end the following new paragraph:
``(4)(A) As part of the counseling program under this subsection,
the Secretary shall emphasize appointing peer support counselors for
women veterans. To the degree practicable, the Secretary shall seek to
recruit women peer support counselors with expertise in--
``(i) female gender-specific issues and services;
``(ii) the provision of information about services and benefits
provided under laws administered by the Secretary; or
``(iii) employment mentoring.
``(B) To the degree practicable, the Secretary shall emphasize
facilitating peer support counseling for women veterans who are
eligible for counseling and services under section 1720D of this title,
have post-traumatic stress disorder or suffer from another mental
health condition, are homeless or at risk of becoming homeless, or are
otherwise at increased risk of suicide, as determined by the Secretary.
``(C) The Secretary shall conduct outreach to inform women veterans
about the program and the assistance available under this paragraph.
``(D) In carrying out this paragraph, the Secretary shall
coordinate with such community organizations, State and local
governments, institutions of higher education, chambers of commerce,
local business organizations, organizations that provide legal
assistance, and other organizations as the Secretary considers
appropriate.
``(E) In carrying out this paragraph, the Secretary shall provide
adequate training for peer support counselors, including training
carried out under the national program of training required by section
304(c) of the Caregivers and Veterans Omnibus Health Services Act of
2010 (38 U.S.C. 1712A note).''.
(b) Funding.--The Secretary of Veterans Affairs shall carry out
paragraph (4) of section 1720F(j) of title 38, United States Code, as
added by subsection (a), using funds otherwise made available to the
Secretary. No additional funds are authorized to be appropriated by
reason of such paragraph.
(c) Report to Congress.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Veterans Affairs shall
submit to the Committees on Veterans' Affairs of the Senate and House
of Representatives a report on the peer support counseling program
under section 1720F(j) of title 38, United States Code, as amended by
this section. Such report shall include--
(1) the number of peer support counselors in the program;
(2) an assessment of the effectiveness of the program; and
(3) a description of the oversight of the program.
Subtitle E--Treating Barriers to Prosperity
SEC. 8061. SHORT TITLE.
This subtitle may be cited as the ``Treating Barriers to Prosperity
Act of 2018''.
SEC. 8062. DRUG ABUSE MITIGATION INITIATIVE.
(a) In General.--Chapter 145 of title 40, United States Code, is
amended by inserting after section 14509 the following:
``Sec. 14510. Drug abuse mitigation initiative
``(a) In General.--The Appalachian Regional Commission may provide
technical assistance to, make grants to, enter into contracts with, or
otherwise provide amounts to individuals or entities in the Appalachian
region for projects and activities to address drug abuse, including
opioid abuse, in the region, including projects and activities--
``(1) to facilitate the sharing of best practices among States,
counties, and other experts in the region with respect to reducing
such abuse;
``(2) to initiate or expand programs designed to eliminate or
reduce the harm to the workforce and economic growth of the region
that results from such abuse;
``(3) to attract and retain relevant health care services,
businesses, and workers; and
``(4) to develop relevant infrastructure, including broadband
infrastructure that supports the use of telemedicine.
``(b) Limitation on Available Amounts.--Of the cost of any activity
eligible for a grant under this section--
``(1) not more than 50 percent may be provided from amounts
appropriated to carry out this section; and
``(2) notwithstanding paragraph (1)--
``(A) in the case of a project to be carried out in a
county for which a distressed county designation is in effect
under section 14526, not more than 80 percent may be provided
from amounts appropriated to carry out this section; and
``(B) in the case of a project to be carried out in a
county for which an at-risk designation is in effect under
section 14526, not more than 70 percent may be provided from
amounts appropriated to carry out this section.
``(c) Sources of Assistance.--Subject to subsection (b), a grant
provided under this section may be provided from amounts made available
to carry out this section in combination with amounts made available--
``(1) under any other Federal program (subject to the
availability of subsequent appropriations); or
``(2) from any other source.
``(d) Federal Share.--Notwithstanding any provision of law limiting
the Federal share under any other Federal program, amounts made
available to carry out this section may be used to increase that
Federal share, as the Appalachian Regional Commission determines to be
appropriate.''.
(b) Clerical Amendment.--The analysis for chapter 145 of title 40,
United States Code, is amended by inserting after the item relating to
section 14509 the following:
``14510. Drug abuse mitigation initiative.''.
Subtitle F--Pilot Program to Help Individuals in Recovery From a
Substance Use Disorder Become Stably Housed
SEC. 8071. 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.--
(A) In general.--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.
(B) Priority.--
(i) In general.--Among such States, priority shall be
given to States with the greatest need, as such need is
determined by the Secretary based on the following factors,
and weighting such factors as described in clause (ii):
(I) The highest average rates of unemployment based
on data provided by the Bureau of Labor Statistics for
calendar years 2013 through 2017.
(II) The lowest average labor force participation
rates based on data provided by the Bureau of Labor
Statistics for calendar years 2013 through 2017.
(III) The highest age-adjusted rates of drug
overdose deaths based on data from the Centers for
Disease Control and Prevention.
(ii) Weighting.--The factors described in clause (i)
shall be weighted as follows:
(I) The rate described in clause (i)(I) shall be
weighted at 15 percent.
(II) The rate described in clause (i)(II) shall be
weighted at 15 percent.
(III) The rate described in clause (i)(III) shall
be weighted at 70 percent.
(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 to any provision under
title I of the Housing and Community Development Act of 1974 (42
U.S.C. 5301 et seq.) except for requirements related to fair
housing, nondiscrimination, labor standards, the environment, and
requirements that activities benefit persons of low- and moderate-
income, upon a finding that such a waiver is necessary to expedite
or facilitate the use of such funds.
(2) Notice of intent.--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 15 business days before such exercise of authority occurs.
(3) Notice to the public.--The Secretary shall provide written
notice of its intent to exercise the authority to specify
alternative requirements under paragraph (1) to the public via
notice, on the internet website of the Department of Housing and
Urban Development, and by other appropriate means, not later than
15 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.
Subtitle G--Human Services
SEC. 8081. 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. 8082. 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. 8083. 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 H--Reauthorizing and Extending Grants for Recovery From Opioid
Use Programs
SEC. 8091. SHORT TITLE.
This subtitle may be cited as the ``Reauthorizing and Extending
Grants for Recovery from Opioid Use Programs Act of 2018'' or the
``REGROUP Act of 2018''.
SEC. 8092. REAUTHORIZATION OF THE COMPREHENSIVE OPIOID ABUSE GRANT
PROGRAM.
Section 1001(a)(27) of the Omnibus Crime Control and Safe Streets
Act of 1968 (34 U.S.C. 10261(a)(27)) is amended by striking ``through
2021'' and inserting ``and 2018, and $330,000,000 for each of fiscal
years 2019 through 2023''.
Subtitle I--Fighting Opioid Abuse in Transportation
SEC. 8101. SHORT TITLE.
This subtitle may be cited as the ``Fighting Opioid Abuse in
Transportation Act''.
SEC. 8102. ALCOHOL AND CONTROLLED SUBSTANCE TESTING OF MECHANICAL
EMPLOYEES.
(a) In General.--Not later than 2 years after the date of enactment
of this Act, the Secretary of Transportation shall publish a rule in
the Federal Register revising the regulations promulgated under section
20140 of title 49, United States Code, to cover all employees of
railroad carriers who perform mechanical activities.
(b) Definition of Mechanical Activities.--For the purposes of the
rule under subsection (a), the Secretary shall define the term
``mechanical activities'' by regulation.
SEC. 8103. 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 or personally
identifiable 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. 8104. 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 8103, 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 8103.
(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 8103 could
be made more effective; and
(4) such other recommendations as the Comptroller General
considers appropriate.
SEC. 8105. TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAM;
ADDITION OF FENTANYL AND OTHER SUBSTANCES.
(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--
(A) determine whether a revision of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs to
expand the opiate category on the list of authorized substance
testing to include fentanyl is justified, based on the
reliability and cost-effectiveness of available testing; and
(B) consider whether to include with the determination
under subparagraph (A) a separate determination on whether a
revision of the Mandatory Guidelines for Federal Workplace Drug
Testing Programs to expand the list of substances authorized
for testing to include any other drugs or other substances
listed in schedule I and II of section 202 of the Controlled
Substances Act (21 U.S.C. 812) is justified based on the
criteria described in subparagraph (A).
(2) Revision of guidelines.--If an expansion of the substance
list 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 list of substances authorized to be tested to
include the substance or substances determined to be justified
for inclusion.
(3) Report.--If an expansion of the substance list 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 list of authorized substances is not justified.
(b) Department of Transportation Drug-testing Panel.--If an
expansion 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 such substances 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 8106 and 8107 of this Act 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 substance testing
to include an additional substance.
SEC. 8106. STATUS REPORTS ON HAIR TESTING GUIDELINES.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, and annually 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; and
(3) 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. 8107. 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 (94 FR
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. 8108. 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. 8109. STATUS REPORTS ON COMMERCIAL DRIVER'S LICENSE DRUG AND
ALCOHOL CLEARINGHOUSE.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, and annually 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 FR 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 J--Eliminating Kickbacks in Recovery
SEC. 8121. SHORT TITLE.
This subtitle may be cited as the ``Eliminating Kickbacks in
Recovery Act of 2018''.
SEC. 8122. CRIMINAL PENALTIES.
(a) In General.--Chapter 11 of title 18, United States Code, is
amended by inserting after section 219 the following:
``Sec. 220. Illegal remunerations for referrals to recovery homes,
clinical treatment facilities, and laboratories
``(a) Offense.--Except as provided in subsection (b), whoever, with
respect to services covered by a health care benefit program, in or
affecting interstate or foreign commerce, knowingly and willfully--
``(1) solicits or receives any remuneration (including any
kickback, bribe, or rebate) directly or indirectly, overtly or
covertly, in cash or in kind, in return for referring a patient or
patronage to a recovery home, clinical treatment facility, or
laboratory; or
``(2) pays or offers any remuneration (including any kickback,
bribe, or rebate) directly or indirectly, overtly or covertly, in
cash or in kind--
``(A) to induce a referral of an individual to a recovery
home, clinical treatment facility, or laboratory; or
``(B) in exchange for an individual using the services of
that recovery home, clinical treatment facility, or laboratory,
shall be fined not more than $200,000, imprisoned not more than 10
years, or both, for each occurrence.
``(b) Applicability.--Subsection (a) shall not apply to--
``(1) a discount or other reduction in price obtained by a
provider of services or other entity under a health care benefit
program if the reduction in price is properly disclosed and
appropriately reflected in the costs claimed or charges made by the
provider or entity;
``(2) a payment made by an employer to an employee or
independent contractor (who has a bona fide employment or
contractual relationship with such employer) for employment, if the
employee's payment is not determined by or does not vary by--
``(A) the number of individuals referred to a particular
recovery home, clinical treatment facility, or laboratory;
``(B) the number of tests or procedures performed; or
``(C) the amount billed to or received from, in part or in
whole, the health care benefit program from the individuals
referred to a particular recovery home, clinical treatment
facility, or laboratory;
``(3) a discount in the price of an applicable drug of a
manufacturer that is furnished to an applicable beneficiary under
the Medicare coverage gap discount program under section 1860D-
14A(g) of the Social Security Act (42 U.S.C. 1395w-114a(g));
``(4) a payment made by a principal to an agent as compensation
for the services of the agent under a personal services and
management contract that meets the requirements of section
1001.952(d) of title 42, Code of Federal Regulations, as in effect
on the date of enactment of this section;
``(5) a waiver or discount (as defined in section
1001.952(h)(5) of title 42, Code of Federal Regulations, or any
successor regulation) of any coinsurance or copayment by a health
care benefit program if--
``(A) the waiver or discount is not routinely provided; and
``(B) the waiver or discount is provided in good faith;
``(6) a remuneration described in section 1128B(b)(3)(I) of the
Social Security Act (42 U.S.C. 1320a-7b(b)(3)(I));
``(7) a remuneration made pursuant to an alternative payment
model (as defined in section 1833(z)(3)(C) of the Social Security
Act) or pursuant to a payment arrangement used by a State, health
insurance issuer, or group health plan if the Secretary of Health
and Human Services has determined that such arrangement is
necessary for care coordination or value-based care; or
``(8) any other payment, remuneration, discount, or reduction
as determined by the Attorney General, in consultation with the
Secretary of Health and Human Services, by regulation.
``(c) Regulations.--The Attorney General, in consultation with the
Secretary of Health and Human Services, may promulgate regulations to
clarify the exceptions described in subsection (b).
``(d) Preemption.--
``(1) Federal law.--This section shall not apply to conduct
that is prohibited under section 1128B of the Social Security Act
(42 U.S.C. 1320a-7b).
``(2) State law.--Nothing in this section shall be construed to
occupy the field in which any provisions of this section operate to
the exclusion of State laws on the same subject matter.
``(e) Definitions.--In this section--
``(1) the terms `applicable beneficiary' and `applicable drug'
have the meanings given those terms in section 1860D-14A(g) of the
Social Security Act (42 U.S.C. 1395w-114a(g));
``(2) the term `clinical treatment facility' means a medical
setting , other than a hospital, that provides detoxification, risk
reduction, outpatient treatment and care, residential treatment, or
rehabilitation for substance use, pursuant to licensure or
certification under State law;
``(3) the term `health care benefit program' has the meaning
given the term in section 24(b);
``(4) the term `laboratory' has the meaning given the term in
section 353 of the Public Health Service Act (42 U.S.C. 263a); and
``(5) the term `recovery home' means a shared living
environment that is, or purports to be, free from alcohol and
illicit drug use and centered on peer support and connection to
services that promote sustained recovery from substance use
disorders.''.
(b) Clerical Amendment.--The table of sections for chapter 11 of
title 18, United States Code, is amended by inserting after the item
related to section 219 the following:
``220. Illegal remunerations for referrals to recovery homes, clinical
treatment facilities, and laboratories.''.
Subtitle K--Substance Abuse Prevention
SEC. 8201. SHORT TITLE.
This subtitle may be cited as the ``Substance Abuse Prevention Act
of 2018''.
SEC. 8202. 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.--
(1) In general.--Section 714 of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1711) is
amended by striking ``such sums as may be necessary for each of
fiscal years 2006 through 2010'' and inserting ``$18,400,000 for
each of fiscal years 2018 through 2023''.
(2) Repeal of termination.--The Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.) is
amended by striking section 715 (21 U.S.C. 1712).
SEC. 8203. REAUTHORIZATION OF THE DRUG-FREE COMMUNITIES PROGRAM.
(a) Revival of National Narcotics Leadership Act of 1988.--
(1) In general.--Chapter 2 of the National Narcotics Leadership
Act of 1988 (21 U.S.C. 1521 et seq.), except for subchapter II (21
U.S.C. 1541 et seq.), as in effect on September 29, 1997, 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) Public Law 107-82 (115 Stat. 814).
(B) The Office of National Drug Control Policy
Reauthorization Act of 2006 (Public Law 109-469: 120 Stat.
3502), as amended by paragraph (4).
(3) Amendment to termination provision.--Section 1009 of the
National Narcotics Leadership Act of 1988 (21 U.S.C. 1056) is
amended by inserting ``and sections 1021 through 1035'' after
``section 1007''.
(4) Technical correction.--
(A) In general.--Title VIII of the Office of National Drug
Control Policy Reauthorization Act of 2006 (Public Law 109-469;
120 Stat. 3535) is amended by striking ``Drug-Free Communities
Act of 1997'' each place it appears and inserting ``National
Narcotics Leadership Act of 1988''.
(B) Effective date.--The amendments made by subparagraph
(A) shall take effect as though enacted as part of the Office
of National Drug Control Policy Reauthorization Act of 2006
(Public Law 109-469; 120 Stat. 3502).
(b) Amendment to National Narcotics Leadership Act of 1988.--
Chapter 2 of subtitle A of title I of the National Narcotics Leadership
Act of 1988 (21 U.S.C. 1521 et seq.) is amended--
(1) in section 1022 (21 U.S.C. 1522), by striking ``substance
abuse'' each place it appears and inserting ``substance use and
misuse'';
(2) in section 1023 (21 U.S.C. 1523), by striking paragraph (9)
and inserting the following:
``(9) Substance use and misuse.--The term `substance use and
misuse' means--
``(A) the illegal use or misuse of drugs, including
substances for which a listing is effect under any of schedules
I through V under section 202 of the Controlled Substances Act
(21 U.S.C. 812);
``(B) the misuse of inhalants or over-the-counter drugs; or
``(C) the use of alcohol, tobacco, or other related product
as such use is prohibited by State or local law.'';
(3) in section 1024 (21 U.S.C. 1524), 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 2023.
``(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.'';
(4) in subchapter I (21 U.S.C. 1531 et seq.)--
(A) by striking ``substance abuse'' each place it appears
and inserting ``substance use and misuse''; and
(B) in section 1032(b)(1)(A) (21 U.S.C. 1532(b)(1)(A)), by
striking clause (iii) and inserting the following:
``(iii) Renewal grants.--Subject to clause (iv), the
Administrator may award a renewal grant to a grant
recipient under this subparagraph for each fiscal year of
the 4-fiscal-year period following the first fiscal year
for which the initial additional grant is awarded in an
amount not to exceed the following:
``(I) For the first and second fiscal years of the
4-fiscal-year period, the amount of the non-Federal
funds, including in-kind contributions, raised by the
coalition for the applicable fiscal year is not less
than 125 percent of the amount awarded.
``(II) For the third and fourth fiscal tears of the
4-fiscal-year period, the amount of the non-Federal
funds, including in-kind contributions, raised by the
coalition for the applicable fiscal year is not less
than 150 percent of the amount awarded.''; and
(5) by striking subchapter II (21 U.S.C. 1541 et seq.).
SEC. 8204. REAUTHORIZATION OF THE NATIONAL COMMUNITY ANTI-DRUG
COALITION INSTITUTE.
Section 4 of Public Law 107-82 (21 U.S.C. 1521 note) is amended to
read as follows:
``SEC. 4. AUTHORIZATION FOR NATIONAL COMMUNITY ANTIDRUG COALITION
INSTITUTE.
``(a) In General.--The Director shall, using amounts authorized to
be appropriated by subsection (d), make a competitive grant to provide
for the continuation of the National Community Anti-drug Coalition
Institute.
``(b) Eligible Organizations.--An organization eligible for the
grant under subsection (a) is any national nonprofit organization that
represents, provides technical assistance and training to, and has
special expertise and broad, national-level experience in community
antidrug coalitions under this subchapter.
``(c) Use of Grant Amount.--The organization that receives the
grant under subsection (a) shall continue a National Community Anti-
Drug Coalition Institute to--
``(1) provide education, training, and technical assistance for
coalition leaders and community teams, with emphasis on the
development of coalitions serving economically disadvantaged areas;
``(2) develop and disseminate evaluation tools, mechanisms, and
measures to better assess and document coalition performance
measures and outcomes; and
``(3) bridge the gap between research and practice by
translating knowledge from research into practical information.
``(d) Authorization of Appropriations.--The Director shall, using
amounts authorized to be appropriated by section 1032 of the National
Narcotics Leadership Act of 1988 (15 U.S.C. 1532), make a grant of $2
million under subsection (a), for each of the fiscal years 2018 through
2023.''.
SEC. 8205. REAUTHORIZATION OF THE HIGH-INTENSITY DRUG TRAFFICKING AREA
PROGRAM.
Section 707 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1706) is amended--
(1) in subsection (f), by striking ``no Federal'' and all that
follows through ``programs.'' and inserting the following: ``not
more than a total of 5 percent of Federal funds appropriated for
the Program are expended for substance use disorder treatment
programs and drug prevention programs.'';
(2) in subsection (p)--
(A) in paragraph (4), by striking ``and'' at the end;
(B) in paragraph (5), by striking the period at the end and
inserting ``; and''; and
(C) by adding at the end the following:
``(6) $280,000,000 for each of fiscal years 2018 through
2023.''; and
(3) in subsection (q)--
(A) by striking paragraph (2) and inserting the following:
``(2) Required uses.--The funds used under paragraph (1) shall
be used to ensure the safety of neighborhoods and the protection of
communities, including the prevention of the intimidation of
witnesses of illegal drug distribution and related activities and
the establishment of, or support for, programs that provide
protection or assistance to witnesses in court proceedings.''; and
(B) by adding at the end the following:
``(3) Best practice models.--The Director shall work with
HIDTAs to develop and maintain best practice models to assist
State, local, and Tribal governments in addressing witness safety,
relocation, financial and housing assistance, or any other services
related to witness protection or assistance in cases of illegal
drug distribution and related activities. The Director shall ensure
dissemination of the best practice models to each HIDTA.''.
SEC. 8206. 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 2023.''.
SEC. 8207. 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.--
``(1) Grants authorized.--The Director may make a grant to a
nonprofit organization for the purpose of providing training and
technical assistance to drug courts.
``(2) Authorization of appropriations.--There is authorized to
be appropriated to carry out this subsection $2,000,000 for each of
fiscal years 2018 through 2023.''.
SEC. 8208. 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. 8209. 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
8208, 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. 8210. 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 for a fiscal
year (beginning with fiscal year 2019) to make competitive grants, in
amounts of not less than $1,000,000 for such 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. 8211. 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 8210, as subsection (m); and
(2) by inserting after subsection (k), as added by section
8210, 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, for a fiscal year (beginning with fiscal
year 2019) 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. 8212. 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 Secretary of Health and Human Services 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 nonprofit national, State, or local organizations that engage
in the following activities:
``(1) Expansion of resource 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.''.
SEC. 8213. 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. 8214. SOBRIETY TREATMENT AND RECOVERY TEAMS (START).
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. 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.''.
SEC. 8215. 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. 8216. DEFINITIONS.
Section 702 of the Office of National Drug Control Policy
Reauthorization Act of 1998 (21 U.S.C. 1701) is amended--
(1) by striking paragraphs (5), (12), and (13);
(2) by redesignating paragraph (11) as paragraph (17);
(3) by redesignating paragraphs (9) and (10) as paragraphs (14)
and (15), respectively;
(4) by redesignating paragraphs (6), (7), and (8) as paragraphs
(10), (11), and (12), respectively;
(5) by redesignating paragraphs (1), (2), (3), and (4) as
paragraphs (3), (4), (5), and (6), respectively;
(6) by inserting before paragraph (3), as so redesignated, the
following:
``(1) Agency.--The term `agency' has the meaning given the term
`executive agency' in section 102 of title 31, United States Code.
``(2) Appropriate congressional committees.--
``(A) In general.--The term `appropriate congressional
committees' means--
``(i) the Committee on the Judiciary, the Committee on
Appropriations, and the Committee on Health, Education,
Labor, and Pensions of the Senate; and
``(ii) the Committee on Oversight and Government
Reform, the Committee on the Judiciary, the Committee on
Energy and Commerce, and the Committee on Appropriations of
the House of Representatives.
``(B) Submission to congress.--Any submission to Congress
shall mean submission to the appropriate congressional
committees.'';
(7) by amending paragraph (3), as so redesignated, to read as
follows:
``(3) Demand reduction.--The term `demand reduction' means any
activity conducted by a National Drug Control Program Agency, other
than an enforcement activity, that is intended to reduce or prevent
the use of drugs or support, expand, or provide treatment and
recovery efforts, including--
``(A) education about the dangers of illicit drug use;
``(B) services, programs, or strategies to prevent
substance use disorder, including evidence-based education
campaigns, community-based prevention programs, collection and
disposal of unused prescription drugs, and services to at-risk
populations to prevent or delay initial use of an illicit drug;
``(C) substance use disorder treatment;
``(D) support for long-term recovery from substance use
disorders;
``(E) drug-free workplace programs;
``(F) drug testing, including the testing of employees;
``(G) interventions for illicit drug use and dependence;
``(H) expanding availability of access to health care
services for the treatment of substance use disorders;
``(I) international drug control coordination and
cooperation with respect to activities described in this
paragraph;
``(J) pre- and post-arrest criminal justice interventions
such as diversion programs, drug courts, and the provision of
evidence-based treatment to individuals with substance use
disorders who are arrested or under some form of criminal
justice supervision, including medication assisted treatment;
``(K) other coordinated and joint initiatives among
Federal, State, local, and Tribal agencies to promote
comprehensive drug control strategies designed to reduce the
demand for, and the availability of, illegal drugs;
``(L) international illicit drug use education, prevention,
treatment, recovery, research, rehabilitation activities, and
interventions for illicit drug use and dependence; and
``(M) research related to illicit drug use and any of the
activities described in this paragraph.'';
(8) by inserting after paragraph (6), as so redesignated, the
following:
``(7) Emerging drug threat.--The term `emerging drug threat'
means the occurrence of a new and growing trend in the use of an
illicit drug or class of drugs, including rapid expansion in the
supply of or demand for such drug.
``(8) Illicit drug use; illicit drugs; illegal drugs.--The
terms `illicit drug use', `illicit drugs', and `illegal drugs'
include the illegal or illicit use of prescription drugs.
``(9) Law enforcement.--The term `law enforcement' or `drug law
enforcement' means all efforts by a Federal, State, local, or
Tribal government agency to enforce the drug laws of the United
States or any State, including investigation, arrest, prosecution,
and incarceration or other punishments or penalties.'';
(9) by amending paragraph (11), as so redesignated, to read as
follows:
``(11) National drug control program agency.--The term
`National Drug Control Program Agency' means any agency (or bureau,
office, independent agency, board, division, commission,
subdivision, unit, or other component thereof) that is responsible
for implementing any aspect of the National Drug Control Strategy,
including any agency that receives Federal funds to implement any
aspect of the National Drug Control Strategy, but does not include
any agency that receives funds for drug control activity solely
under the National Intelligence Program or the Joint Military
Intelligence Program.'';
(10) in paragraph (12), as so redesignated--
(A) by inserting ``or `Strategy''' before ``means''; and
(B) by inserting ``, including any report, plan, or
strategy required to be incorporated into or issued
concurrently with such strategy'' before the period at the end;
(11) by inserting after paragraph (12), as so redesignated, the
following:
``(13) Nonprofit organization.--The term `nonprofit
organization' means an organization that is described in section
501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax
under section 501(a) of such Code.'';
(12) in paragraph (14), as so redesignated, by striking
``Unless the context clearly indicates otherwise, the'' and
inserting ``The'';
(13) by inserting after paragraph (15), as so redesignated, the
following:
``(16) Substance use disorder treatment.--The term `substance
use disorder treatment' means an evidence-based, professionally
directed, deliberate, and planned regimen including evaluation,
observation, medical monitoring, and rehabilitative services and
interventions such as pharmacotherapy, behavioral therapy, and
individual and group counseling, on an inpatient or outpatient
basis, to help patients with substance use disorder reach
recovery.''; and
(14) in paragraph (17), as so redesignated--
(A) by redesignating subparagraphs (B), (C), (D), and (E),
as subparagraphs (C), (D), (E), and (F), respectively;
(B) by inserting after subparagraph (A) the following:
``(B) domestic law enforcement;'';
(C) in subparagraph (E), as so redesignated, by striking
``and'' at the end;
(D) in subparagraph (F), as so redesignated, by striking
the period at the end and inserting a semicolon; and
(E) by adding at the end the following:
``(G) activities to prevent the diversion of drugs for
their illicit use; and
``(H) research related to any of the activities described
in this paragraph.''.
SEC. 8217. AMENDMENTS TO ADMINISTRATION OF THE OFFICE.
(a) Responsibilities of Office.--Section 703(a) of the Office of
National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C.
1702(a)) is amended--
(1) by striking paragraph (1) and inserting the following:
``(1) lead the national drug control effort, including
coordinating with the National Drug Control Program Agencies;'';
(2) in paragraph (2), by inserting before the semicolon the
following: ``, including the National Drug Control Strategy'';
(3) in paragraph (3), by striking ``and'' at the end; and
(4) by striking paragraph (4) and all that follows through
``the National Academy of Sciences.'' and inserting the following:
``(4) evaluate the effectiveness of national drug control
policy efforts, including the National Drug Control Program
Agencies' program, by developing and applying specific goals and
performance measurements and monitoring the agencies' program-level
spending;
``(5) identify and respond to emerging drug threats related to
illicit drug use;
``(6) administer the Drug-Free Communities Program, the High-
Intensity Drug Trafficking Areas Program, and other grant programs
directly authorized to be administered by the Office in furtherance
of the National Drug Control Strategy; and
``(7) facilitate broad-scale information sharing and data
standardization among Federal, State, and local entities to support
the national drug control efforts.''.
(b) Ethics Guidelines.--Section 703(d) of the Office of National
Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1702(d)) is
amended by adding at the end the following:
``(4) Ethics guidelines.--The Director shall establish written
guidelines setting forth the criteria to be used in determining
whether a gift or donation should be declined under this subsection
because the acceptance of the gift or donation would--
``(A) reflect unfavorably upon the ability of the Director
or the Office, or any employee of the Office, to carry out
responsibilities or official duties under this chapter in a
fair and objective manner; or
``(B) compromise the integrity or the appearance of
integrity of programs or services provided under this chapter
or of any official involved in those programs or services.
``(5) Registry of gifts.--The Director shall maintain a list
of--
``(A) the source and amount of each gift or donation
accepted by the Office; and
``(B) the source and amount of each gift or donation
accepted by a contractor to be used in its performance of a
contract for the Office.
``(6) Report to congress.--The Director shall include in the
annual assessment under section 706(g) a copy of the registry
maintained under paragraph (5).''.
(c) Appointment of Director and Deputy Director.--Section 704(a) of
the Office of National Drug Control Policy Reauthorization Act of 1998
(21 U.S.C. 1703(a)) is amended--
(1) in paragraph (1), by striking subparagraphs (A), (B), and
(C), and inserting the following:
``(A) Director.--
``(i) In general.--There shall be at the head of the
Office a Director who shall hold the same rank and status
as the head of an executive department listed in section
101 of title 5, United States Code.
``(ii) Appointment.--The Director shall be appointed by
the President, by and with the advice and consent of the
Senate, and shall serve at the pleasure of the President.
``(B) Deputy director.--There shall be a Deputy Director
who shall report directly to the Director, and who shall be
appointed by the President, and shall serve at the pleasure of
the President.
``(C) Coordinators.--The following coordinators shall be
appointed by the Director:
``(i) Performance Budget Coordinator, as described in
section 704(c)(4).
``(ii) Interdiction Coordinator, as described in
section 711.
``(iii) Emerging and Continuing Threats Coordinator, as
described in section 709.
``(iv) State, Local, and Tribal Affairs Coordinator, to
carry out the activities described in section 704(j).
``(v) Demand Reduction Coordinator, as described in
subparagraph (D).
``(D) Demand reduction coordinator.--The Director shall
designate or appoint a United States Demand Reduction
Coordinator to be responsible for the activities described in
section 702(3). The Director shall determine whether the
coordinator position is a noncareer appointee in the Senior
Executive Service or a career appointee in a position at level
15 of the General Schedule (or equivalent).'';
(2) in paragraph (5), by striking ``such official'' and
inserting ``such officer or employee''; and
(3) by adding at the end the following:
``(6) Prohibition on the use of funds for ballot initiatives.--
No funds authorized under this title may be obligated for the
purpose of expressly advocating the passage or defeat of a State or
local ballot initiative.''.
(d) Consultation.--Section 704(b) of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1703(b)) is
amended--
(1) in paragraph (19), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (20), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(21) in order to formulate the national drug control
policies, goals, objectives, and priorities--
``(A) shall consult with and assist--
``(i) State and local governments;
``(ii) National Drug Control Program Agencies;
``(iii) each committee, working group, council, or
other entity established under this chapter, as
appropriate;
``(iv) the public;
``(v) appropriate congressional committees; and
``(vi) any other person in the discretion of the
Director; and
``(B) may--
``(i) establish advisory councils;
``(ii) acquire data from agencies; and
``(iii) request data from any other entity.''.
(e) National Drug Control Program Budget.--Section 704(c) of the
Office of National Drug Control Policy Reauthorization Act of 1998 (21
U.S.C. 1703(c)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A), by striking ``paragraph (1)(C);''
and inserting the following: ``paragraph (1)(C) and include--
``(i) the funding level for each National Drug Control
Program agency; and
``(ii) alternative funding structures that could
improve progress on achieving the goals fo the National
Drug Control Strategy; and'';
(B) in subparagraph (B), strike ``the President; and'' and
inserting ``the President and Congress.''; and
(C) by striking subparagraph (C);
(2) in paragraph (3)(E), by striking clause (ii) and inserting
the following:
``(ii) Certification.--The Director shall--
``(I) review each budget submission submitted under
subparagraph (A);
``(II) based on the review under clause (i), make a
determination as to whether the budget submission of a
National Drug Control Program agency includes the
funding levels and initiatives described in
subparagraph (B); and
``(III) submit to the appropriate congressional
committees--
``(aa) a written statement that either--
``(AA) certifies that the budget submission
includes sufficient funding; or
``(BB) decertifies the budget submission as
not including sufficient funding;
``(bb) a copy of the description made under
subparagraph (B); and
``(cc) the budget recommendations made under
subsection (b)(8).''; and
(3) by adding at the end the following:
``(5) Performance-budget coordinator.--
``(A) Designation.--The Director shall designate or appoint
a United States Performance-Budget Coordinator to--
``(i) ensure the Director has sufficient information
necessary to analyze the performance of each National Drug
Control Program Agency, the impact Federal funding has had
on the goals in the Strategy, and the likely contributions
to the goals of the Strategy based on funding levels of
each National Drug Control Program Agency, to make an
independent assessment of the budget request of each agency
under this subsection;
``(ii) advise the Director on agency budgets,
performance measures and targets, and additional data and
research needed to make informed policy decisions under
this section and section 706; and
``(iii) other duties as may be determined by the
Director with respect to measuring or assessing performance
or agency budgets.
``(B) Determination of position.--The Director shall
determine whether the coordinator position is a noncareer
appointee in the Senior Executive Service or a career appointee
in a position at level 15 of the General Schedule (or
equivalent).
``(6) Budget estimate or request submission to congress.--
Whenever the Director submits any budget estimate or request to the
President or the Office of Management and Budget, the Director
shall concurrently transmit to the appropriate congressional
committees a detailed statement of the budgetary needs of the
Office to execute its mission based on the good-faith assessment of
the Director.''.
(f) Powers and Responsibilities of the Director.--Section 704 of
the Office of National Drug Control Policy Reauthorization Act of 1998
(21 U.S.C. 1703) is amended--
(1) in subsection (d)(8)--
(A) in subparagraph (D), by striking ``and'' at the end;
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``Congress, including to the
Committees on Appropriations of the Senate and the
House of Representatives, the authorizing committees
for the Office,'' and inserting ``the appropriate
congressional committees''; and
(II) by striking ``or agencies'';
(ii) in clause (ii)--
(I) by striking ``Congress'' and inserting ``the
appropriate congressional committees''; and
(II) by adding ``and'' at the end; and
(iii) by adding at the end the following:
``(iii) funds may only be used for--
``(I) expansion of demand reduction activities;
``(II) interdiction of illicit drugs on the high
seas, in United States territorial waters, and at
United States ports of entry by officers and employees
of National Drug Control Program Agencies and domestic
and foreign law enforcement officers;
``(III) accurate assessment and monitoring of
international drug production and interdiction programs
and policies;
``(IV) activities to facilitate and enhance the
sharing of domestic and foreign intelligence
information among National Drug Control Program
Agencies related to the production and trafficking of
drugs in the United States and foreign countries; and
``(V) research related to any of these
activities.'';
(2) in subsection (e)(2)(A), by striking ``Notwithstanding any
other provision of law'' and inserting ``Subject to the
availability of appropriations''; and
(3) by adding at the end the following:
``(i) Model Acts Program.--
``(1) In general.--The Director shall provide for or shall
enter into an agreement with a nonprofit organization to--
``(A) advise States on establishing laws and policies to
address illicit drug use issues; and
``(B) revise such model State drug laws and draft
supplementary model State laws to take into consideration
changes in illicit drug use issues in the State involved.
``(2) Authorization of appropriations.--There is authorized to
be appropriated to carry out this subsection $1,250,000 for each of
fiscal years 2018 through 2023.
``(j) State, Local, and Tribal Affairs Coordinator.--The Director
shall designate or appoint a United States State, Local, and Tribal
Affairs Coordinator to perform the duties of the Office outlined in
this section and 706 and such other duties as may be determined by the
Director with respect to coordination of drug control efforts between
agencies and State, local, and Tribal governments. The Director shall
determine whether the coordinator position is a noncareer appointee in
the Senior Executive Service or a career appointee in a position at
level 15 of the General Schedule (or equivalent).
``(k) Harm Reduction Programs.--When developing the national drug
control policy, any policy of the Director, including policies relating
to syringe exchange programs for intravenous drug users, shall be based
on the best available medical and scientific evidence regarding the
effectiveness of such policy in promoting individual health and
preventing the spread of infectious disease and the impact of such
policy on drug addiction and use. In making any policy relating to harm
reduction programs, the Director shall consult with the National
Institutes of Health and the National Academy of Sciences.''.
(g) Accounting of Funds Expended.--Section 705 of the Office of
National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C.
1704(d)), as amended by section 8207 is further amended--
(1) by amending subsection (d) to read as follows:
``(d) Accounting of Funds Expended.--
``(1) In general.--Not later than February 1 of each year, in
accordance with guidance issued by the Director, the head of each
National Drug Control Program Agency shall submit to the Director a
detailed accounting of all funds expended by the agency for
National Drug Control Program activities during the previous fiscal
year and shall ensure such detailed accounting is authenticated for
the previous fiscal year by the Inspector General for such agency
prior to the submission to the Director as frequently as determined
by the Inspector General but not less frequently that every 3
years.
``(2) Submission to congress.--The Director shall submit to
Congress not later than April 1 of each year the information
submitted to the Director under paragraph (1).''; and
(2) by adding at the end the following:
``(f) Tracking System for Federally Funded Grant Programs.--
``(1) Establishment.--The Director, or the head of an agency
designated by the Director, in coordination with the Secretary of
Health and Human Services, shall track federally-funded grant
programs to--
``(A) ensure the public has electronic access to
information identifying:
``(i) all drug control grants and pertinent identifying
information for each grant;
``(ii) any available performance metrics, evaluations,
or other information indicating the effectiveness of such
programs;
``(B) facilitate efforts to identify duplication, overlap,
or gaps in funding to provide increased accountability of
Federally-funded grants for substance use disorder treatment,
prevention, and enforcement; and
``(C) identify barriers in the grant application process
impediments that applicants currently have in the grant
application process with applicable agencies.
``(2) National drug control agencies.--The head of each
National Drug Control Program Agency shall provide to the Director
a complete list of all drug control program grant programs and any
other relevant information for inclusion in the system developed
under paragraph (1) and annually update such list.
``(3) Updating existing systems.--The Director may meet the
requirements of this subsection by utilizing, updating, or
improving existing Federal information systems to ensure they meet
the requirements of this subsection.
``(4) Report.--Not later than 3 years after the date of
enactment of this subsection, the Comptroller General of the United
States shall submit to Congress a report examining implementation
of this subsection.''.
(h) Technical and Conforming Amendment.--Section 1105 of the Office
of National Drug Control Policy Reauthorization Act of 2006 (21 U.S.C.
1701 note) is repealed.
SEC. 8218. EMERGING THREATS COMMITTEE, PLAN, AND MEDIA CAMPAIGN.
(a) In General.--Section 709 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1708) is amended to read
as follows:
``SEC. 709. EMERGING THREATS COMMITTEE, PLAN, AND MEDIA CAMPAIGN.
``(a) Emerging Threats Coordinator.--The Director shall designate
or appoint a United States Emerging and Continuing Threats Coordinator
to perform the duties of that position described in this section and
such other duties as may be determined by the Director. The Director
shall determine whether the coordinator position is a noncareer
appointee in the Senior Executive Service or a career appointee in a
position at level 15 of the General Schedule (or equivalent).
``(b) Emerging Threats Committee.--
``(1) In general.--The Emerging Threats Committee shall--
``(A) monitor evolving and emerging drug threats in the
United States;
``(B) identify and discuss evolving and emerging drug
trends in the United States using the criteria required to be
established under paragraph (6);
``(C) assist in the formulation of and oversee
implementation of any plan described in subsection (d);
``(D) provide such other advice to the Coordinator and
Director concerning strategy and policies for emerging drug
threats and trends as the Committee determines to be
appropriate; and
``(E) disseminate and facilitate the sharing with Federal,
State, local, and Tribal officials and other entities as
determined by the Director of pertinent information and data
relating to--
``(i) recent trends in drug supply and demand;
``(ii) fatal and nonfatal overdoses;
``(iii) demand for and availability of evidence-based
substance use disorder treatment, including the extent of
the unmet treatment need, and treatment admission trends;
``(iv) recent trends in drug interdiction, supply, and
demand from State, local, and Tribal law enforcement
agencies; and
``(v) other subject matter as determined necessary by
the Director.
``(2) Chairperson.--The Director shall designate one of the
members of the Emerging Threats Committee to serve as Chairperson.
``(3) Members.--The Director shall appoint other members of the
Committee, which shall include--
``(A) representatives from National Drug Control Program
Agencies or other agencies;
``(B) representatives from State, local, and Tribal
governments; and
``(C) representatives from other entities as designated by
the Director.
``(4) Meetings.--The members of the Emerging Threats Committee
shall meet, in person and not through any delegate or
representative, not less frequently than once per calendar year,
before June 1. At the call of the Director or the Chairperson, the
Emerging Threats Committee may hold additional meetings as the
members may choose.
``(5) Contract, agreement, and other authority.--The Director
may award contracts, enter into interagency agreements, manage
individual projects, and conduct other activities in support of the
identification of emerging drug threats and in support of the
development, implementation, and assessment of any Emerging Threat
Response Plan.
``(6) Criteria to identify emerging drug threats.--Not later
than 180 days after the date on which the Committee first meets,
the Committee shall develop and recommend to the Director criteria
to be used to identify an emerging drug threat or the termination
of an emerging drug threat designation based on information
gathered by the Committee, statistical data, and other evidence.
``(c) Designation.--
``(1) In general.--The Director, in consultation with the
Coordinator, the Committee, and the head of each National Drug
Control Program Agency, may designate an emerging drug threat in
the United States.
``(2) Standards for designation.--The Director, in consultation
with the Coordinator, shall promulgate and make publicly available
standards by which a designation under paragraph (1) and the
termination of such designation may be made. In developing such
standards, the Director shall consider the recommendations of the
committee and other criteria the Director considers to be
appropriate.
``(3) Public statement required.--The Director shall publish a
public written statement on the portal of the Office explaining the
designation of an emerging drug threat or the termination of such
designation and shall notify the appropriate congressional
committees of the availability of such statement when a designation
or termination of such designation has been made.
``(d) Plan.--
``(1) Public availability of plan.--Not later than 90 days
after making a designation under subsection (c), the Director shall
publish and make publicly available an Emerging Threat Response
Plan and notify the President and the appropriate congressional
committees of such plan's availability.
``(2) Timing.--Concurrently with the annual submissions under
section 706(g), the Director shall update the plan and report on
implementation of the plan, until the Director issues the public
statement required under subsection (c)(3) to terminate the
emerging drug threat designation.
``(3) Contents of an emerging threat response plan.--The
Director shall include in the plan required under this subsection--
``(A) a comprehensive strategic assessment of the emerging
drug threat, including the current availability of, demand for,
and effectiveness of evidence-based prevention, treatment, and
enforcement programs and efforts to respond to the emerging
drug threat;
``(B) comprehensive, research-based, short- and long-term,
quantifiable goals for addressing the emerging drug threat,
including for reducing the supply of the drug designated as the
emerging drug threat and for expanding the availability and
effectiveness of evidence-based substance use disorder
treatment and prevention programs to reduce the demand for the
emerging drug threat;
``(C) performance measures pertaining to the plan's goals,
including quantifiable and measurable objectives and specific
targets;
``(D) the level of funding needed to implement the plan,
including whether funding is available to be reprogrammed or
transferred to support implementation of the plan or whether
additional appropriations are necessary to implement the plan;
``(E) an implementation strategy for the media campaign
under subsection (f), including goals as described under
subparagraph (B) of this paragraph and performance measures,
objectives, and targets, as described under subparagraph (C) of
this paragraph; and
``(F) any other information necessary to inform the public
of the status, progress, or response of an emerging drug
threat.
``(4) Implementation.--
``(A) In general.--Not later than 120 days after the date
on which a designation is made under subsection (c), the
Director, in consultation with the President, the appropriate
congressional committees, and the head of each National Drug
Control Program Agency, shall issue guidance on implementation
of the plan described in this subsection to the National Drug
Control Program Agencies and any other relevant agency
determined to be necessary by the Director.
``(B) Coordinator's responsibilities.--The Coordinator
shall--
``(i) direct the implementation of the plan among the
agencies identified in the plan, State, local, and Tribal
governments, and other relevant entities;
``(ii) facilitate information-sharing between agencies
identified in the plan, State, local, and Tribal
governments, and other relevant entities; and
``(iii) monitor implementation of the plan by
coordinating the development and implementation of
collection and reporting systems to support performance
measurement and adherence to the plan by agencies
identified in plan, where appropriate.
``(C) Reporting.--Not later than 180 days after the date on
which a designation is made under subsection (c) and in
accordance with subparagraph (A), the head of each agency
identified in the plan shall submit to the Coordinator a report
on implementation of the plan.
``(e) Evaluation of Media Campaign.--Upon designation of an
emerging drug threat, the Director shall evaluate whether a media
campaign would be appropriate to address that threat.
``(f) National Anti-drug Media Campaign.--
``(1) In general.--The Director shall, to the extent feasible
and appropriate, conduct a national anti-drug media campaign
(referred to in this subtitle as the `national media campaign') in
accordance with this subsection for the purposes of--
``(A) preventing substance abuse among people in the United
States;
``(B) educating the public about the dangers and negative
consequences of substance use and abuse, including patient and
family education about the characteristics and hazards of
substance abuse and methods to safeguard against substance use,
to include the safe disposal of prescription medications;
``(C) supporting evidence-based prevention programs
targeting the attitudes, perception, and beliefs of persons
concerning substance use and intentions to initiate or continue
such use;
``(D) encouraging individuals affected by substance use
disorders to seek treatment and providing such individuals with
information on--
``(i) how to recognize addiction issues;
``(ii) what forms of evidence-based treatment options
are available; and
``(iii) how to access such treatment;
``(E) combating the stigma of addiction and substance use
disorders, including the stigma of treating such disorders with
medication-assisted treatment therapies; and
``(F) informing the public about the dangers of any drug
identified by the Director as an emerging drug threat as
appropriate.
``(2) Use of funds.--
``(A) In general.--Amounts made available to carry out this
subsection for the national media campaign may only be used for
the following:
``(i) The purchase of media time and space, including
the strategic planning for, tracking, and accounting of,
such purchases.
``(ii) Creative and talent costs, consistent with
subparagraph (B)(i).
``(iii) Advertising production costs, which may include
television, radio, internet, social media, and other
commercial marketing venues.
``(iv) Testing and evaluation of advertising.
``(v) Evaluation of the effectiveness of the national
media campaign.
``(vi) Costs of contracts to carry out activities
authorized by this subsection.
``(vii) Partnerships with professional and civic
groups, community-based organizations, including faith-
based organizations, and government organizations related
to the national media campaign.
``(viii) Entertainment industry outreach, interactive
outreach, media projects and activities, public
information, news media outreach, and corporate sponsorship
and participation.
``(ix) Operational and management expenses.
``(B) Specific requirements.--
``(i) Creative services.--In using amounts for creative
and talent costs under subparagraph (A)(ii), the Director
shall use creative services donated at no cost to the
Government wherever feasible and may only procure creative
services for advertising--
``(I) responding to high-priority or emergent
campaign needs that cannot timely be obtained at no
cost; or
``(II) intended to reach a minority, ethnic, or
other special audience that cannot reasonably be
obtained at no cost.
``(ii) Testing and evaluation of advertising.--In using
amounts for testing and evaluation of advertising under
subparagraph (A)(iv), the Director shall test all
advertisements prior to use in the national media campaign
to ensure that the advertisements are effective with the
target audience and meet industry-accepted standards. The
Director may waive this requirement for advertisements
using no more than 10 percent of the purchase of
advertising time purchased under this subsection in a
fiscal year and no more than 10 percent of the advertising
space purchased under this subsection in a fiscal year, if
the advertisements respond to emergent and time-sensitive
campaign needs or the advertisements will not be widely
utilized in the national media campaign.
``(iii) Consultation.--For the planning of the campaign
under paragraph (1), the Director may consult with--
``(I) the head of any appropriate National Drug
Control Program Agency;
``(II) experts on the designated drug;
``(III) State, local, and Tribal government
officials and relevant agencies;
``(IV) communications professionals;
``(V) the public; and
``(VI) appropriate congressional committees.
``(iv) Evaluation of effectiveness of national media
campaign.--In using amounts for the evaluation of the
effectiveness of the national media campaign under
subparagraph (A)(v), the Director shall--
``(I) designate an independent entity to evaluate
by April 20 of each year the effectiveness of the
national media campaign based on data from--
``(aa) the Monitoring the Future Study
published by the Department of Health and Human
Services;
``(bb) the National Survey on Drug Use and
Health; and
``(cc) other relevant studies or publications,
as determined by the Director, including tracking
and evaluation data collected according to
marketing and advertising industry standards; and
``(II) ensure that the effectiveness of the
national media campaign is evaluated in a manner that
enables consideration of whether the national media
campaign has contributed to changes in attitude or
behaviors among the target audience with respect to
substance use and such other measures of evaluation as
the Director determines are appropriate.
``(3) Advertising.--In carrying out this subsection, the
Director shall ensure that sufficient funds are allocated to meet
the stated goals of the national media campaign.
``(4) Responsibilities and functions under the program.--
``(A) In general.--The Director shall determine the overall
purposes and strategy of the national media campaign.
``(B) Director.--
``(i) In general.--The Director shall approve--
``(I) the strategy of the national media campaign;
``(II) all advertising and promotional material
used in the national media campaign; and
``(III) the plan for the purchase of advertising
time and space for the national media campaign.
``(ii) Implementation.--The Director shall be
responsible for implementing a focused national media
campaign to meet the purposes set forth in paragraph (1)
and shall ensure--
``(I) information disseminated through the campaign
is accurate and scientifically valid; and
``(II) the campaign is designed using strategies
demonstrated to be the most effective at achieving the
goals and requirements of paragraph (1), which may
include--
``(aa) a media campaign, as described in
paragraph (2);
``(bb) local, regional, or population specific
messaging;
``(cc) the development of websites to publicize
and disseminate information;
``(dd) conducting outreach and providing
educational resources for parents;
``(ee) collaborating with law enforcement
agencies; and
``(ff) providing support for school-based
public health education classes to improve teen
knowledge about the effects of substance use.
``(5) Prohibitions.--None of the amounts made available under
paragraph (2) may be obligated or expended for any of the
following:
``(A) To supplant current anti-drug community-based
coalitions.
``(B) To supplant pro bono public service time donated by
national and local broadcasting networks for other public
service campaigns.
``(C) For partisan political purposes, or to express
advocacy in support of or to defeat any clearly identified
candidate, clearly identified ballot initiative, or clearly
identified legislative or regulatory proposal.
``(D) To fund advertising that features any elected
officials, persons seeking elected office, cabinet level
officials, or other Federal officials employed pursuant to
section 213 of Schedule C of title 5, Code of Federal
Regulations.
``(E) To fund advertising that does not contain a primary
message intended to reduce or prevent substance use.
``(F) To fund advertising containing a primary message
intended to promote support for the national media campaign or
private sector contributions to the national media campaign.
``(6) Matching requirement.--
``(A) In general.--Amounts made available under paragraph
(2) for media time and space shall be matched by an equal
amount of non-Federal funds for the national media campaign, or
be matched with in-kind contributions of the same value.
``(B) No-cost match advertising direct relationship
requirement.--The Director shall ensure that not less than 85
percent of no-cost match advertising directly relates to
substance abuse prevention consistent with the specific
purposes of the national media campaign.
``(C) No-cost match advertising not directly related.--The
Director shall ensure that no-cost match advertising that does
not directly relate to substance abuse prevention consistent
with the purposes of the national media campaign includes a
clear anti-drug message. Such message is not required to be the
primary message of the match advertising.
``(7) Financial and performance accountability.--The Director
shall cause to be performed--
``(A) audits and reviews of costs of the national media
campaign pursuant to section 4706 of title 41, United States
Code; and
``(B) an audit to determine whether the costs of the
national media campaign are allowable under chapter 43 of title
41, United States Code.
``(8) Report to congress.--The Director shall submit on an
annual basis a report to Congress that describes--
``(A) the strategy of the national media campaign and
whether specific objectives of the national media campaign were
accomplished;
``(B) steps taken to ensure that the national media
campaign operates in an effective and efficient manner
consistent with the overall strategy and focus of the national
media campaign;
``(C) plans to purchase advertising time and space;
``(D) policies and practices implemented to ensure that
Federal funds are used responsibly to purchase advertising time
and space and eliminate the potential for waste, fraud, and
abuse;
``(E) all contracts entered into with a corporation,
partnership, or individual working on behalf of the national
media campaign;
``(F) the results of any financial audit of the national
media campaign;
``(G) a description of any evidence used to develop the
national media campaign;
``(H) specific policies and steps implemented to ensure
compliance with this section;
``(I) a detailed accounting of the amount of funds
obligated during the previous fiscal year for carrying out the
national media campaign, including each recipient of funds, the
purpose of each expenditure, the amount of each expenditure,
any available outcome information, and any other information
necessary to provide a complete accounting of the funds
expended; and
``(J) a review and evaluation of the effectiveness of the
national media campaign strategy for the past year.
``(9) Required notice for communication from the office.--Any
communication, including an advertisement, paid for or otherwise
disseminated by the Office directly or through a contract awarded
by the Office shall include a prominent notice informing the
audience that the communication was paid for by the Office.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to the Office to carry out this section, $25,000,000 for
each of fiscal years 2018 through 2023.''.
(b) Technical and Conforming Amendment.--Subsection (a) of section
203 of the Office of National Drug Control Policy Reauthorization Act
of 2006 (21 U.S.C. 1708a) is repealed.
SEC. 8219. DRUG INTERDICTION.
(a) Repeal.--This first section 711 of the Office of National Drug
Control Policy Reauthorization Act of 1998 (21 U.S.C. 1710) is
repealed.
(b) Amendments.--Section 711 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1710), as added by Public
Law 109-469 (120 Stat. 3507), is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``The United'' and inserting ``The
Director shall designate or appoint an appointee in the
Senior Executive Service or an appointee in a position at
level 15 of the General Schedule (or equivalent) as the
United''; and
(ii) by striking ``shall'' and inserting ``to'';
(B) in paragraph (2)(B)--
(i) by striking ``March 1'' and inserting ``September
1''; and
(ii) by striking ``paragraph (3)'' and inserting
``paragraph (4)'';
(C) in paragraph (3)--
(i) by striking ``also, at his discretion,''; and
(ii) by striking ``the Office of Supply Reduction for
that purpose'' and inserting ``assist in carrying out such
responsibilities''; and
(D) in paragraph (4)--
(i) in subparagraph (B), by striking ``The United'' and
inserting ``Before submission of the National Drug Control
Strategy or annual assessment required under section 706,
as applicable, the United'';
(ii) by striking subparagraphs (C) and (E);
(iii) by redesignating subparagraph (D) as subparagraph
(C);
(iv) in subparagraph (C), as so redesignated--
(I) in the matter preceding clause (i)--
(aa) by striking ``March 1'' and inserting
``September 1'';
(bb) by inserting ``the Director, acting
through'' before ``the United States'';
(cc) by inserting a comma after
``Coordinator'';
(dd) by striking ``a report on behalf of the
Director''; and
(ee) by striking ``, which shall include'' and
inserting ``a report that'';
(II) by redesignating clauses (i), (ii), and (iii)
as subclauses (I), (II), and (III), and adjusting the
margins accordingly;
(III) by inserting before subclause (I), as so
redesignated, the following:
``(i) includes--'';
(IV) in clause (i), as so redesignated--
(aa) in subclause (I), as so redesignated, by
inserting ``, including information about how each
National Drug Control Program agency conducting
drug interdiction activities is engaging with
relevant international partners'' after ``Plan'';
(bb) in subclause (II), as so redesignated, by
striking ``, as well as'' and inserting ``and'';
(cc) in subclause III, as so redesignated--
(AA) by striking ``, as well as'' and
inserting ``and''; and
(BB) by striking the period at the end and
inserting ``; and''; and
(V) by adding at the end the following:
``(ii) may include recommendations for changes to
existing agency authorities or laws governing interagency
relationships.''; and
(v) by adding at the end the following:
``(D) Classified annex.--Each report required to be
submitted under subparagraph (C) shall be in unclassified form,
but may include a classified annex.'';
(2) in subsection (b)--
(A) in paragraph (1)(B), by inserting ``and how to
strengthen international partnerships to better achieve the
goals of that plan'' after ``that plan'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking ``Chairman''
and inserting ``Chairperson''; and
(ii) by striking ``chairman'' and inserting
``Chairperson'';
(C) in paragraph (3)--
(i) by striking ``prior to March 1'' and inserting
``before June 1'';
(ii) by striking ``either'' each place it appears;
(iii) by striking ``current chairman'' and inserting
``Chairperson''; and
(iv) by striking ``they'' and inserting ``the
members''; and
(D) in paragraph (4)--
(i) by striking ``chairman'' each place it appears and
inserting ``Chairperson'';
(ii) in the first sentence, by striking ``a report'';
(iii) by inserting ``a report'' after ``committees'';
and
(iv) by striking the second sentence and inserting the
following: ``The report required under this paragraph shall
be in unclassified form, but may include a classified
annex.''; and
(3) by adding at the end the following:
``(c) International Coordination.--The Director may facilitate
international drug control coordination efforts.''.
SEC. 8220. GAO AUDIT.
Not later than 4 years after the date of enactment of this Act, and
every 4 years thereafter, the Comptroller General of the United States
shall--
(1) conduct an audit relating to the programs and operations
of--
(A) the Office; and
(B) certain programs within the Office, including--
(i) the High Intensity Drug Trafficking Areas Program;
(ii) the Drug-Free Communities Program; and
(iii) the campaign under section 709(f) of the Office
of National Drug Control Policy Reauthorization Act of 1998
(21 U.S.C. 1708(f)); and
(2) submit to the Director and the appropriate congressional
committees a report containing an evaluation of and recommendations
on the--
(A) policies and activities of the programs and operations
subject to the audit;
(B) economy, efficiency, and effectiveness in the
administration of the reviewed programs and operations; and
(C) policy or management changes needed to prevent and
detect fraud and abuse in such programs and operations.
SEC. 8221. NATIONAL DRUG CONTROL STRATEGY.
(a) In General.--Section 706 of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1705) is amended to read
as follows:
``SEC. 706. NATIONAL DRUG CONTROL STRATEGY.
``(a) In General.--
``(1) Statement of drug policy priorities.--The Director shall
release a statement of drug control policy priorities in the
calendar year of a Presidential inauguration following the
inauguration, but not later than April 1.
``(2) National drug control strategy submitted by the
president.--Not later than the first Monday in February following
the year in which the term of the President commences, and every 2
years thereafter, the President shall submit to Congress a National
Drug Control Strategy.
``(b) Development of the National Drug Control Strategy.--
``(1) Promulgation.--The Director shall promulgate the National
Drug Control Strategy, which shall set forth a comprehensive plan
to reduce illicit drug use and the consequences of such illicit
drug use in the United States by limiting the availability of and
reducing the demand for illegal drugs and promoting prevention,
early intervention, treatment, and recovery support for individuals
with substance use disorders.
``(2) State and local commitment.--The Director shall seek the
support and commitment of State, local, and Tribal officials in the
formulation and implementation of the National Drug Control
Strategy.
``(3) Strategy based on evidence.--The Director shall ensure
the National Drug Control Strategy is based on the best available
evidence regarding the policies that are most effective in reducing
the demand for and supply of illegal drugs.
``(4) Process for development and submission of national drug
control strategy.--In developing and effectively implementing the
National Drug Control Strategy, the Director--
``(A) shall consult with--
``(i) the heads of the National Drug Control Program
Agencies;
``(ii) each Coordinator listed in section 704;
``(iii) the Interdiction Committee and the Emerging
Threats Committee;
``(iv) the appropriate congressional committees and any
other committee of jurisdiction;
``(v) State, local, and Tribal officials;
``(vi) private citizens and organizations, including
community and faith-based organizations, with experience
and expertise in demand reduction;
``(vii) private citizens and organizations with
experience and expertise in supply reduction; and
``(viii) appropriate representatives of foreign
governments; and
``(B) in satisfying the requirements of subparagraph (A),
shall ensure, to the maximum extent possible, that State,
local, and Tribal officials and relevant private organizations
commit to support and take steps to achieve the goals and
objectives of the National Drug Control Strategy.
``(c) Contents of the National Drug Control Strategy.--
``(1) In general.--The National Drug Control Strategy submitted
under subsection (a)(2) shall include the following:
``(A) A mission statement detailing the major functions of
the National Drug Control Program.
``(B) Comprehensive, research-based, long-range,
quantifiable goals for reducing illicit drug use, and the
consequences of illicit drug use in the United States.
``(C) Annual quantifiable and measurable objectives and
specific targets to accomplish long-term quantifiable goals
that the Director determines may be achieved during each year
beginning on the date on which the National Drug Control
Strategy is submitted.
``(D) A 5-year projection for the National Drug Control
Program and budget priorities.
``(E) A review of international, State, local, and private
sector drug control activities to ensure that the United States
pursues coordinated and effective drug control at all levels of
government.
``(F) A description of how each goal established under
subparagraph (B) will be achieved, including for each goal--
``(i) a list of each relevant National Drug Control
Program Agency and each such agency's related programs,
activities, and available assets and the role of each such
program, activity, and asset in achieving such goal;
``(ii) a list of relevant stakeholders and each such
stakeholder's role in achieving such goal;
``(iii) an estimate of Federal funding and other
resources needed to achieve such goal;
``(iv) a list of each existing or new coordinating
mechanism needed to achieve such goal; and
``(v) a description of the Office's role in
facilitating the achievement of such goal.
``(G) For each year covered by the Strategy, a performance
evaluation plan for each goal established under subparagraph
(B) for each National Drug Control Program Agency, including--
``(i) specific performance measures for each National
Drug Control Program Agency;
``(ii) annual and, to the extent practicable, quarterly
objectives and targets for each performance measure; and
``(iii) an estimate of Federal funding and other
resources needed to achieve each performance objective and
target.
``(H) A list identifying existing data sources or a
description of data collection needed to evaluate performance,
including a description of how the Director will obtain such
data.
``(I) A list of any anticipated challenges to achieving the
National Drug Control Strategy goals and planned actions to
address such challenges.
``(J) A description of how each goal established under
subparagraph (B) was determined, including--
``(i) a description of each required consultation and a
description of how such consultation was incorporated; and
``(ii) data, research, or other information used to
inform the determination to establish the goal.
``(K) A description of the current prevalence of illicit
drug use in the United States, including both the availability
of illicit drugs and the prevalence of substance use disorders.
``(L) Such other statistical data and information as the
Director considers appropriate to demonstrate and assess trends
relating to illicit drug use, the effects and consequences of
illicit drug use (including the effects on children), supply
reduction, demand reduction, drug-related law enforcement, and
the implementation of the National Drug Control Strategy.
``(M) A systematic plan for increasing data collection to
enable real time surveillance of drug control threats,
developing analysis and monitoring capabilities, and
identifying and addressing policy questions related to the
National Drug Control Strategy and Program, which shall
include--
``(i) a list of policy-relevant questions for which the
Director and each National Drug Control Program Agency
intends to develop evidence to support the National Drug
Control Program and Strategy;
``(ii) a list of data the Director and each National
Drug Control Program Agency intends to collect, use, or
acquire to facilitate the use of evidence in drug control
policymaking and monitoring;
``(iii) a list of methods and analytical approaches
that may be used to develop evidence to support the
National Drug Control Program and Strategy and related
policy;
``(iv) a list of any challenges to developing evidence
to support policymaking, including any barriers to
accessing, collecting, or using relevant data;
``(v) a description of the steps the Director and the
head of each National Drug Control Program Agency will take
to effectuate the plan; and
``(vi) any other relevant information as determined by
the Director.
``(N) A plan to expand treatment of substance use
disorders, which shall--
``(i) identify unmet needs for treatment for substance
use disorders and a strategy for closing the gap between
available and needed treatment;
``(ii) describe the specific roles and responsibilities
of the relevant National Drug Control Programs for
implementing the plan;
``(iii) identify the specific resources required to
enable the relevant National Drug Control Agencies to
implement that strategy; and
``(iv) identify the resources, including private
sources, required to eliminate the unmet need for evidence-
based substance use disorder treatment.
``(2) Consultation.--In developing the plan required under
paragraph (1), the Director shall consult with the following:
``(A) The public.
``(B) Any evaluation or analysis units and personnel of the
Office.
``(C) Office officials responsible for implementing privacy
policy.
``(D) Office officials responsible for data governance.
``(E) The appropriate congressional committees.
``(F) Any other individual or entity as determined by the
Director.
``(3) Additional strategies.--
``(A) In general.--The Director shall include in the
National Drug Control Strategy the additional strategies
described under this paragraph and shall comply with the
following:
``(i) Provide a copy of the additional strategies to
the appropriate congressional committees and to the
Committee on Armed Services and the Committee on Homeland
Security of the House of Representatives, and the Committee
on Homeland Security and Governmental Affairs and the
Committee on Armed Services of the Senate.
``(ii) Issue the additional strategies in consultation
with the head of each relevant National Drug Control
Program Agency, any relevant official of a State, local, or
Tribal government, and the government of other relevant
countries.
``(iii) Not change any existing agency authority or
construe any strategy described under this paragraph to
amend or modify any law governing interagency relationship
but may include recommendations about changes to such
authority or law.
``(iv) Present separately from the rest of any strategy
described under this paragraph any information classified
under criteria established by an Executive order, or whose
public disclosure, as determined by the Director or the
head of any relevant National Drug Control Program Agency,
would be detrimental to the law enforcement or national
security activities of any Federal, State, local, or Tribal
agency.
``(B) Requirement for southwest border counternarcotics
strategy.--
``(i) Purposes.--The Southwest Border Counternarcotics
Strategy shall--
``(I) set forth the Government's strategy for
preventing the illegal trafficking of drugs across the
international border between the United States and
Mexico, including through ports of entry and between
ports of entry on that border;
``(II) state the specific roles and
responsibilities of the relevant National Drug Control
Program Agencies for implementing that strategy; and
``(III) identify the specific resources required to
enable the relevant National Drug Control Program
Agencies to implement that strategy.
``(ii) Specific content related to drug tunnels between
the united states and mexico.--The Southwest Border
Counternarcotics Strategy shall include--
``(I) a strategy to end the construction and use of
tunnels and subterranean passages that cross the
international border between the United States and
Mexico for the purpose of illegal trafficking of drugs
across such border; and
``(II) recommendations for criminal penalties for
persons who construct or use such a tunnel or
subterranean passage for such a purpose.
``(C) Requirement for northern border counternarcotics
strategy.--
``(i) Purposes.--The Northern Border Counternarcotics
Strategy shall--
``(I) set forth the strategy of the Federal
Government for preventing the illegal trafficking of
drugs across the international border between the
United States and Canada, including through ports of
entry and between ports of entry on the border;
``(II) state the specific roles and
responsibilities of each relevant National Drug Control
Program Agency for implementing the strategy;
``(III) identify the specific resources required to
enable the relevant National Drug Control Program
Agencies to implement the strategy;
``(IV) be designed to promote, and not hinder,
legitimate trade and travel; and
``(V) reflect the unique nature of small
communities along the international border between the
United States and Canada, ongoing cooperation and
coordination with Canadian law, enforcement
authorities, and variations in the volumes of vehicles
and pedestrians crossing through ports of entry along
the international border between the United States and
Canada.
``(ii) Specific content related to cross-border indian
reservations.--The Northern Border Counternarcotics
Strategy shall include--
``(I) a strategy to end the illegal trafficking of
drugs to or through Indian reservations on or near the
international border between the United States and
Canada; and
``(II) recommendations for additional assistance,
if any, needed by Tribal law enforcement agencies
relating to the strategy, including an evaluation of
Federal technical and financial assistance,
infrastructure capacity building, and interoperability
deficiencies.
``(4) Classified information.--Any contents of the National
Drug Control Strategy that involve information properly classified
under criteria established by an Executive order shall be presented
to Congress separately from the rest of the National Drug Control
Strategy.
``(5) Selection of data and information.--In selecting data and
information for inclusion in the Strategy, the Director shall
ensure--
``(A) the inclusion of data and information that will
permit analysis of current trends against previously compiled
data and information where the Director believes such analysis
enhances long-term assessment of the National Drug Control
Strategy; and
``(B) the inclusion of data and information to permit a
standardized and uniform assessment of the effectiveness of
drug treatment programs in the United States.
``(d) Submission of Revised Strategy.--The President may submit to
Congress a revised National Drug Control Strategy that meets the
requirements of this section--
``(1) at any time, upon a determination of the President, in
consultation with the Director, that the National Drug Control
Strategy in effect is not sufficiently effective; or
``(2) if a new President or Director takes office.
``(e) Failure of Director to Submit National Drug Control
Strategy.--If the Director does not submit a National Drug Control
Strategy to Congress in accordance with subsection (a)(2), not later
than five days after the first Monday in February following the year in
which the term of the President commences, the Director shall send a
notification to the appropriate congressional committees--
``(1) explaining why the Strategy was not submitted; and
``(2) specifying the date by which the Strategy will be
submitted.
``(f) Drug Control Data Dashboard.--
``(1) In general.--The Director shall collect and disseminate,
as appropriate, such information as the Director determines is
appropriate, but not less than the information described in this
subsection. The data shall be publicly available in a machine-
readable format on the online portal of the Office, and to the
extent practicable on the Drug Control Data Dashboard.
``(2) Establishment.--The Director shall publish to the online
portal of the office in a machine-readable, sortable, and
searchable format, or to the extent practicable, establish and
maintain a data dashboard on the online portal of the Office to be
known as the `Drug Control Data Dashboard'. To the extent
practicable, when establishing the Drug Control Dashboard, the
Director shall ensure the user interface of the dashboard is
constructed with modern design standards. To the extent
practicable, the data made available on the dashboard shall be
publicly available in a machine-readable format and searchable by
year, agency, drug, and location.
``(3) Data.--The data included in the Drug Control Data
Dashboard shall be updated quarterly to the extent practicable, but
not less frequently than annually and shall include, at a minimum,
the following:
``(A) For each substance identified by the Director as
having a significant impact on the prevalence of illicit drug
use--
``(i) data sufficient to show the quantities of such
substance available in the United States, including--
``(I) the total amount seized and disrupted in the
calendar year and each of the previous 3 calendar
years, including to the extent practicable the amount
seized by State, local, and Tribal governments;
``(II) the known and estimated flows into the
United States from all sources in the calendar year and
each of the previous 3 calendar years;
``(III) the total amount of known flows that could
not be interdicted or disrupted in the calendar year
and each of the previous 3 calendar years;
``(IV) the known and estimated levels of domestic
production in the calendar year and each of the
previous three calendar years, including the levels of
domestic production if the drug is a prescription drug,
as determined under the Federal Food, Drug, and
Cosmetic Act, for which a listing is in effect under
section 202 of the Controlled Substances Act (21 U.S.C.
812);
``(V) the average street price for the calendar
year and the highest known street price during the
preceding 10-year period; and
``(VI) to the extent practicable, related
prosecutions by State, local, and Tribal governments;
``(ii) data sufficient to show the frequency of use of
such substance, including--
``(I) use of such substance in the workplace and
productivity lost by such use;
``(II) use of such substance by arrestees,
probationers, and parolees;
``(III) crime and criminal activity related to such
substance;
``(IV) to the extent practicable, related
prosecutions by State, local, and Tribal governments;
``(B) For the calendar year and each of the previous three
years data sufficient to show, disaggregated by State and, to
the extent feasible, by region within a State, county, or city,
the following:
``(i) The number of fatal and non-fatal overdoses
caused by each drug identified under subparagraph (A)(i).
``(ii) The prevalence of substance use disorders.
``(iii) The number of individuals who have received
substance use disorder treatment, including medication
assisted treatment, for a substance use disorder, including
treatment provided through publicly-financed health care
programs.
``(iv) The extent of the unmet need for substance use
disorder treatment, including the unmet need for
medication-assisted treatment.
``(C) Data sufficient to show the extent of prescription
drug diversion, trafficking, and misuse in the calendar year
and each of the previous 3 calendar years.
``(D) Any quantifiable measures the Director determines to
be appropriate to detail progress toward the achievement of the
goals of the National Drug Control Strategy.
``(g) Development of an Annual National Drug Control Assessment.--
``(1) Timing.--Not later than the first Monday in February of
each year, the Director shall submit to the President, Congress,
and the appropriate congressional committees, a report assessing
the progress of each National Drug Control Program Agency toward
achieving each goal, objective, and target contained in the
National Drug Control Strategy applicable to the prior fiscal year.
``(2) Process for development of the annual assessment.--Not
later than November 1 of each year, the head of each National Drug
Control Program Agency shall submit, in accordance with guidance
issued by the Director, to the Director an evaluation of progress
by the agency with respect to the National Drug Control Strategy
goals using the performance measures for the agency developed under
this title, including progress with respect to--
``(A) success in achieving the goals of the National Drug
Control Strategy;
``(B) success in reducing domestic and foreign sources of
illegal drugs;
``(C) success in expanding access to and increasing the
effectiveness of substance use disorder treatment;
``(D) success in protecting the borders of the United
States (and in particular the Southwestern border of the United
States) from penetration by illegal narcotics;
``(E) success in reducing crime associated with drug use in
the United States;
``(F) success in reducing the negative health and social
consequences of drug use in the United States;
``(G) implementation of evidence-based substance use
disorder treatment and prevention programs in the United States
and improvements in the adequacy and effectiveness of such
programs; and
``(H) success in increasing the prevention of illicit drug
use.
``(3) Contents of the annual assessment.--The Director shall
include in the annual assessment required under paragraph (1)--
``(A) a summary of each evaluation received by the Director
under paragraph (2);
``(B) a summary of the progress of each National Drug
Control Program Agency toward the National Drug Control
Strategy goals of the agency using the performance measures for
the agency developed under this chapter;
``(C) an assessment of the effectiveness of each National
Drug Control Program Agency and program in achieving the
National Drug Control Strategy for the previous year, including
a specific evaluation of whether the applicable goals,
measures, objectives, and targets for the previous year were
met; and
``(D) the assessments required under this subsection shall
be based on the Performance Measurement System.''.
(b) Technical and Conforming Amendments.--
(1) Section 704(b) of the Office of National Drug Control
Policy Reauthorization Act of 1998 (21 U.S.C. 1703(b)) is amended--
(A) by striking paragraphs (13) and (17); and
(B) in paragraph (14)(A), by striking ``paragraph (13)''
and inserting ``section 706(g)(2)''.
(2) The Office of National Drug Control Policy Reauthorization
Act of 2006 (Public Law 109-469; 120 Stat. 3502) is amended by
striking sections 1110 and 1110A.
SEC. 8222. TECHNICAL AND CONFORMING AMENDMENTS 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) by striking section 703(b) (21 U.S.C. 1702(b));
(2) in section 704 (21 U.S.C. 1703)--
(A) in subsection (c)--
(i) in paragraph (3)(C)--
(I) in the matter before clause (i), by inserting
``requests a level of funding that will not enable
achievement of the goals of the National Drug Control
Strategy, including'' after ``request that'';
(II) in clause (iii)--
(aa) by striking ``drug treatment'' and
inserting ``substance use disorder prevention and
treatment''; and
(bb) by striking the semicolon at the end and
inserting ``; and'';
(III) by striking clauses (iv), (vi), and (vii);
(IV) by redesignating clause (v) as clause (iv);
and
(V) in clause (iv), as so redesignated, by striking
the semicolon and inserting a period;
(ii) in paragraph (4)(A), by striking ``$1,000,000''
and inserting ``$5,000,000 or 10 percent of a specific
program or account''; and
(B) in subsection (f)--
(i) by striking the first paragraph (5); and
(ii) by striking the second paragraph (4); and
(3) by striking section 708 (21 U.S.C. 1707).
Subtitle L--Budgetary Effects
SEC. 8231. BUDGETARY EFFECT.
(a) In General.--The budgetary effects of this Act shall not be
entered on either PAYGO scorecard maintained pursuant to section 4(d)
of the Statutory Pay-As-You-Go Act of 2010 (2 U.S.C. 933(d)).
(b) Senate PAYGO Scorecards.--The budgetary effects of this Act
shall not be entered on any PAYGO scorecard maintained for purposes of
section 4106 of H. Con. Res. 71 (115th Congress).
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.