[Congressional Record Volume 164, Number 161 (Friday, September 28, 2018)]
[House]
[Pages H9174-H9255]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SUBSTANCE USE-DISORDER PREVENTION THAT PROMOTES OPIOID RECOVERY AND
TREATMENT FOR PATIENTS AND COMMUNITIES ACT
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and agree to the
resolution (H. Res. 1099) providing for the concurrence by the House in
the Senate amendment to H.R. 6, with an amendment.
The Clerk read the title of the resolution.
The text of the resolution is as follows:
H. Res. 1099
Resolved, That upon the adoption of this resolution the
House shall be considered to have taken from the Speaker's
table the bill, H.R. 6, with the Senate amendment thereto,
and to have concurred in the Senate amendment with the
following amendment:
In lieu of the matter proposed to be inserted by the
amendment of the Senate to the text of the bill, insert the
following:
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.
[[Page H9175]]
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.
[[Page H9176]]
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.
[[Page H9177]]
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
[[Page H9178]]
``(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
[[Page H9179]]
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:
[[Page H9180]]
``(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
[[Page H9181]]
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
[[Page H9182]]
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.
[[Page H9183]]
(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.
[[Page H9184]]
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--
[[Page H9185]]
(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
[[Page H9186]]
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.
[[Page H9187]]
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--
[[Page H9188]]
``(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)
[[Page H9189]]
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
[[Page H9190]]
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.
[[Page H9191]]
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:
[[Page H9192]]
``(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
[[Page H9193]]
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
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(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
[[Page H9195]]
(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
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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
[[Page H9197]]
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
[[Page H9198]]
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.
[[Page H9199]]
``(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.--
[[Page H9200]]
``(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--
[[Page H9201]]
``(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.
[[Page H9202]]
(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)).
[[Page H9203]]
(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''.
[[Page H9204]]
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.
[[Page H9205]]
(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.
[[Page H9206]]
(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.
[[Page H9207]]
(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
[[Page H9208]]
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
[[Page H9209]]
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,
[[Page H9210]]
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
[[Page H9211]]
``(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.
[[Page H9212]]
``(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--
[[Page H9213]]
(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--
[[Page H9214]]
(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
[[Page H9215]]
(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
[[Page H9216]]
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.
[[Page H9217]]
(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
[[Page H9218]]
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).
[[Page H9219]]
(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:
[[Page H9220]]
``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
[[Page H9221]]
``(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;
[[Page H9222]]
``(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).
[[Page H9223]]
``(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
[[Page H9224]]
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.
[[Page H9225]]
``(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.
[[Page H9226]]
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.
[[Page H9227]]
(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--
[[Page H9228]]
(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.
[[Page H9229]]
(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
[[Page H9230]]
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;
[[Page H9231]]
``(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.
[[Page H9232]]
(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
[[Page H9233]]
(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.''.
[[Page H9234]]
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
[[Page H9235]]
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,
[[Page H9236]]
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--
[[Page H9237]]
(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.''.
[[Page H9238]]
(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.
[[Page H9239]]
``(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.
[[Page H9240]]
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;
[[Page H9241]]
``(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
[[Page H9242]]
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).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous material in the Record on the resolution.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
[[Page H9243]]
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
I have dozens and dozens of letters of support for this legislation;
90 or 100 different letters of support from different groups, 124
names, it looks like, that I will include in the Record.
Statements and Letters of Support from:
U.S. Chamber--Key Vote Alert, American Society of Addiction
Medicine--Statement, Advocates for Opioid Recovery--advocacy
e-mail, Corporate Health Care Coalition--support letter,
First Focus Campaign for Children--statement, National
Association for Behavioral Healthcare--Statement, National
Association of Community Health Centers--Letter, Catholic
Health Association--Letter, American Benefits Council--
Letter, A Coalition letter signed by 124 addiction advocacy
groups:
1. A New PATH, San Diego, California
2. Addiction Policy Forum
3. AIDS United
4. Alabama, Addiction Policy Forum
5. Alaska, Addiction Policy Forum
6. American Correctional Association
7. Arizona, Addiction Policy Forum
8. Association of Prosecuting Attorneys
9. Beyond Addiction Ministry, WI
10. Brave Health
11. CADA of Northwest Louisiana
12. California Consortium of Addiction Programs &
Professionals (CCAPP)
13. California, Addiction Policy Forum
14. Campaign for Youth Justice
15. Caron Treatment Centers
16. CFC Loud N Clear Foundation, Farmingdale, New Jersey
17. Chicago Recovering Communities Coalition, Chicago,
Illinois
18. Colorado, Addiction Policy Forum
19. Community Anti-Drug Coalitions of America (CADCA)
20. Connecticut Certification Board
21. Connecticut Community for Addiction Recovery (CCAR),
Hartford, Connecticut
22. Connecticut, Addiction Policy Forum
23. COPES
24. DarJune Recovery Support Services & Cafe, Green Bay,
Wisconsin
25. Delaware, Addiction Policy Forum
26. Delphi Behavioral Health Group
27. DisposeRx
28. El Paso Alliance, El Paso, Texas
29. Faces & Voices of Recovery
30. FAVOR Low Country, Charleston, South Carolina
31. FAVOR Tri-County, Rock Hill, South Carolina
32. FedCURE
33. Fellowship Foundation Recovery Community Organization,
Margate, Florida
34. Floridians for Recovery, West Palm Beach, Florida
35. Foundation for Recovery, Las Vegas, Nevada
36. Friends of Emmett
37. H.O.P.E.S. Forever
38. Healthcare Leadership Council
39. IC & RC
40. Idaho, Addiction Policy Forum
41. Illinois Association of Behavioral Health
42. Illinois, Addiction Policy Forum
43. Indiana, Addiction Policy Forum
44. Institute for Behavior and Health (IBH)
45. Iowa, Addiction Policy Forum
46. Jackson Area Recovery Community, Jackson, Michigan
47. Kansas, Addiction Policy Forum
48. Kentucky, Addiction Policy Forum
49. Kingston NH Lions Foundation
50. Lifehouse Recovery Connection, San Diego, California
51. Maine Alliance for Addiction Recovery, Augusta, Maine
52. Maine, Addiction Policy Forum
53. Maryland House Detox
54. Maryland, Addiction Policy Forum
55. Massachusetts, Addiction Policy Forum
56. Michigan, Addiction Policy Forum
57. Minnesota Recovery Connection, Minneapolis, Minnesota
58. Minnesota, Addiction Policy Forum
59. Missouri Recovery Network, Jefferson City, Missouri
60. Missouri, Addiction Policy Forum
61. Montana, Addiction Policy Forum
62. National Association of Social Workers (NASW)
63. National Prevention Science Coalition
64. National Safety Council
65. Navigate Recovery Gwinnett, Gwinnett County, Georgia
66. Navigating Recovery of the Lakes Region, Laconia, New
Hampshire
67. Nevada, Addiction Policy Forum
68. New Hampshire, Addiction Policy Forum
69. New Jersey, Addiction Policy Forum
70. New Mexico, Addiction Policy Forum
71. New York, Addiction Policy Forum
72. North Carolina, Addiction Policy Forum
73. North Dakota, Addiction Policy Forum
74. Ohio Citizen Advocates for Addiction Recovery,
Columbus, Ohio
75. Ohio, Addiction Policy Forum
76. Oklahoma, Addiction Policy Forum
77. Oregon, Addiction Policy Forum
78. PEER Wellness Center
79. PEER360 Recovery Alliance, Bay City, Michigan
80. Pennsylvania Recovery Organization, Achieving Community
Together (PRO-ACT), Philadelphia, Pennsylvania
81. Pennsylvania, Addiction Policy Forum
82. People Advocating Recovery, Louisville, Kentucky
83. Phoenix House Recovery Residences
84. PLR Athens, Athens, Georgia
85. Reality Check, Jaffrey, New Hampshire
86. Recover Wyoming, Cheyenne, Wyoming
87. Recovery Communities of North Carolina, Raleigh, North
Carolina
88. Recovery Community Connection, Williamsport,
Pennsylvania
89. Recovery Community of Durham, Durham, North Carolina
90. Recovery Data Solutions
91. Rhode Island, Addiction Policy Forum
92. ROCovery Fitness, Rochester, New York
93. Shatterproof
94. Smart Approaches to Marijuana Action (SAM Action)
95. SMART Recovery, Nationwide
96. Sobriety Matters
97. Solutions Recovery, Oshkosh, Wisconsin
98. South Dakota, Addiction Policy Forum
99. SpiritWorks Foundation, Williamsburg, Virginia
100. Springs Recovery Connection, Colorado Springs,
Colorado
101. Strengthening the Mid-Atlantic Region for Tomorrow
(SMART)
102. Tennessee, Addiction Policy Forum
103. Texas, Addiction Policy Forum
104. The DOOR--DeKalb Open Opportunity for Recovery,
Decatur, Georgia
105. The McShin Foundation, Richmond, Virginia
106. The Moyer Foundation
107. The Phoenix, Nationwide
108. The RASE Project, Harrisburg, Pennsylvania
109. The Solano Project, Fairfield, California
110. Treatment Communities of America
111. Trilogy Recovery Community, Walla Walla, Washington
112. Trust for America's Health
113. Utah, Addiction Policy Forum
114. Vermont, Addiction Policy Forum
115. Virginia, Addiction Policy Forum
116. Voices of Hope Lexington, Lexington, Kentucky
117. Voices of Recovery San Mateo County, San Mateo,
California
118. WAI-IAM, Inc. and RISE Recovery Community, Lansing,
Michigan
119. Washington, Addiction Policy Forum
120. Washtenaw Recovery Advocacy Project (WRAP), Ann Arbor,
Michigan
121. West Virginia, Addiction Policy Forum
122. Wisconsin Voices for Recovery, Madison, Wisconsin
123. Wisconsin, Addiction Policy Forum
124. Wyoming, Addiction Policy Forum
Mr. WALDEN. Mr. Speaker, I rise today in support of H.R. 6. This is
the SUPPORT for Patients and Communities Act that your Energy and
Commerce Committee has worked on diligently for nearly 2 years.
In my own case, in 10 roundtables throughout Oregon, I have heard
from everyday people on the frontlines of this fight in our
communities. They are the victims. They are the families. They are
medical providers and treatment advocates. They are local law
enforcement, and they are first responders. They are our neighbors.
They are our loved ones.
Each of these people puts a name and a face to what I would say is
the worst drug epidemic we have seen in America, the opioid crisis.
I have heard from Oregon families, I have heard from Mike and Winnie,
from Grants Pass, who have seen their loved one struggle with
addiction. Mike's sister who died, she was a nurse, became addicted,
and overdosed. He told me that at a townhall in a community forum.
Their son struggles with his addiction to this day from a sports injury
starting with opioids, ending with heroin.
We will never know what could have become of the 72,000 Americans who
died last year.
Every 24 hours, 1,000 people go to emergency rooms overdosing from
opioids. Roughly 115 die.
I heard it from Paula, whose two sons and stepson struggle with their
opioid addiction today.
As a parent, I can only imagine what parents of children with opioid
addiction must feel every time the phone rings. They think it may be
that call.
For the millions of people currently struggling with addiction,
please know, don't give up. It is never too late to seek help. We stand
with you.
Mr. Speaker, this legislation is a product of months of bipartisan,
bicameral work, eight House committees involved, I think probably every
Member of this House, five Senate committees, dozen and dozens of
Members of Congress.
And the faces that we came to know are the parents and the children
whom they lost, Amanda Beatrice Gray being one of them, a beautiful
young woman, talented, struggling with her issues, overdosed on heroin
heavily laced with fentanyl.
We are here for them, Mr. Speaker. We are here for our neighbors, for
our
[[Page H9244]]
loved ones, who deal with this crisis every day of their life, and in
the great joined cause of those who lost.
Mr. Speaker, because we are going to hear from a lot of our Members
who have put so much work into this, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
I rise today in support of H.R. 6, the SUPPORT for Patients and
Communities Act. This bill is the product of many months of hard work
by several committees in the House and Senate. It is important that we
pass this bill today as another step in addressing the opioid crisis
that is ravaging every community in our Nation.
Last year, a record 72,000 Americans died of drug overdoses; that is
about 200 people dying every day, and this is a national crisis that is
devastating families and that this Congress must act on.
And while this legislation will not solve every problem, I do believe
it includes important policies that will help turn the tide of this
tragic opioid epidemic. It will also improve treatment options for
those battling other substance-use disorders.
I am proud that H.R. 6 builds upon CARA, the Comprehensive Addiction
and Recovery Act, by including a provision championed by my colleague,
Congressman Tonko, that would allow all advanced practice registered
nurses to treat patients with bupe for opioid-use disorder. It also
gives nurse practitioners and physician assistants the authority to
treat patients with bupe permanently, and it codifies the 275 patient
physician cap. This is a critical step in expanding access to the
treatment of these drugs, one of the major challenges that we continue
to face in the fight against this epidemic.
Mr. Speaker, the legislation also expands access to coverage. It
includes an important provision that I worked on with Ways and Means
Committee Ranking Member Neal that expands Medicare coverage of opioid
treatment programs and medication-assisted treatment.
In the Medicaid space, I am pleased to see the inclusion of several
Democratic priorities. This bill requires State Medicaid programs to
cover all forms of medication-assisted treatment, which plays a
critical and lifesaving role in treating opioid use disorder.
It provides grants to State Medicaid programs to help increase the
number of substance use disorder providers and services. It increases
access to mental health and substance use disorder treatment for
children and pregnant women covered by CHIP, and it ensures former
foster youth are able to keep their Medicaid coverage across State
lines up to the age of 26. And it improves the continuity of Medicaid
coverage for juveniles in the justice system.
I am also pleased that we have been able to improve upon the House-
passed IMD policy. This bill adds new safeguards to ensure that States
continue to provide an adequate level of outpatient services and offer
medication-assisted treatment. It does this by making clear that this
policy does not impact the more comprehensive efforts to provide care
in IMDs that is ongoing in many States today.
{time} 1045
H.R. 6 also includes provisions from my legislation, the SCREEN Act,
that would give the Food and Drug Administration the ability to take
action against illicit controlled substances coming in through
international mail facilities across the country.
FDA will now be able to prohibit the importation of drugs by people
who have repeatedly imported illicit drugs. It also allows the agency
to cease distribution of or recall controlled substances, like opioids,
if they are endangering patients.
These provisions also provide FDA expanded authority and capacity
needed to more effectively combat the influx of deadly synthetic
opioids, like fentanyl, from reaching our shores through the mail in
the first place.
It also provides the Federal Trade Commission with stronger
enforcement tools to go after bad actors that are taking advantage of
the suffering of individuals combating addictions.
Mr. Speaker, there is one provision that is concerning and that I do
want to mention. It did not go through regular order and was not
properly vetted. In fact, it was added at the very last minute. That is
a proposal by Senator Rubio to create a new criminal antikickback
statute.
I know this proposal is well-intentioned in addressing the serious
problem of patient brokers who are taking advantage of individuals with
opioid use disorders and referring them to substandard or fraudulent
providers in exchange for kickbacks. This is an issue, but since the
bill was introduced last Tuesday night, multiple stakeholders have
raised concerns that the language does not do what we think it does. It
may have unintended consequences.
Mr. Speaker, I hope this is a good lesson to all of us that passing
legislation that has not been properly vetted, and that the public has
not had an adequate chance to review, is unwise. I hope to get a
commitment from Chairman Walden and Chairman Goodlatte to work to
address any technical problems with this provision in the upcoming
months.
In closing, Mr. Speaker, these are all policies that have the
potential to make a real impact on this epidemic, but our work here is
not complete. An epidemic of this size will take a long-term commitment
to improving health insurance coverage, treatment, access, and
affordability.
This bill is an important step, but I want to stress that we have to
do a lot more. The opioid crisis continues to get worse. A lot more
needs to be done to provide treatment and expand the treatment
infrastructure. More resources are needed to support the families and
communities impacted by this crisis. So what we are doing today is
clearly helpful, but it is not enough.
Mr. Speaker, I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I am honored to yield 1 minute to the
gentleman from Texas (Mr. Brady), the distinguished and talented
chairman of the House Ways and Means Committee.
Mr. BRADY of Texas. Mr. Speaker, I thank Chairman Walden and Ranking
Member Pallone for their work. The opioid crisis, as you know, has
impacted every community in America, has robbed countless individuals
of their full potential. We all know someone who lost a loved one
because they were exposed to opioids and then quickly addicted, and I
know that sometimes, in routine surgery, they didn't even need it.
This can be prevented, and that is why I rise today in support of
H.R. 6. This is bicameral and bipartisan. It addresses this crisis by
putting in place many commonsense measures to reduce the unnecessary
prescribing of opioids and get people treatment once they become
addicted.
Mr. Speaker, I want to thank the ranking member of the Ways and Means
Committee, Mr. Neal; the ranking member of the Health Subcommittee, Mr.
Levin; as well as leaders on our side and Mr. Roskam, Mr. Curbelo, Mr.
Paulsen, and Mr. Bishop for authorizing key provisions of H.R. 6. They
will save lives and heal communities.
Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from
Massachusetts (Mr. Neal), the ranking member of the Ways and Means
Committee who worked so hard on this legislation as well.
Mr. NEAL. Mr. Speaker, I rise in support of H.R. 6, the SUPPORT for
Patients and Communities Act, and I want to acknowledge Mr. Pallone,
Mr. Walden, and Mr. Brady, the chairman of the Ways and Means
Committee, for the good work that they have offered on this as well.
The opioid crisis is not a partisan issue. It is a health, safety,
family, community, and economic issue. Everybody in this Chamber today
has a family member or knows someone close to them who is connected to
the opioid crisis.
H.R. 6 represents the best of bipartisan and bicameral negotiation.
This is, indeed, the way policy can and should be done.
The bill includes a number of Democratic priorities to expand
treatment options for our neighbors, family members, and friends
suffering from opioid use disorders. It includes my bill, with Member
Pallone, that would require Medicare to cover opioid treatment programs
so that our Nation's seniors might have more outpatient options for
treatment.
[[Page H9245]]
Opioid use disorders are rapidly growing among Medicare
beneficiaries. In 13 States, the highest rate of opioid-related
inpatient hospital stays is amongst those over 65. This policy would
give Medicare beneficiaries increased access to a range of medication
and behavioral treatment options, leading to more hope for long-term
recovery.
I am also pleased that H.R. 6 includes the Securing the International
Mail Against Opioids Act, which would help to stop the flow of opioids
through the United States. This legislation stems from the STOP Act, a
bill that I worked on with Mr. Tiberi before his retirement earlier
this year. I want to commend him, in addition to Trade Subcommittee
Ranking Member Pascrell, for their work on this bipartisan legislation.
While the bill before us is a step in the right direction, this
epidemic is not going to turn around overnight. It needs a thoughtful,
long-term, sustainable approach that requires significant Federal
investments. H.R. 6 represents the initial step in addressing this
crisis, but it cannot be the end. Part of that long-term approach must
include protecting and strengthening Medicaid and the Affordable Care
Act.
I want to take a moment to thank the staff on both sides of the aisle
for their usual good work in this Chamber, for the weeks of hard effort
they put in bringing this bill to fruition. The effort exemplifies
bipartisan cooperation, and a particular thanks to House and Senate
legislative counsel who worked long nights and weekends to finish the
bill.
Thanks also to the CMS Office of Legislation and the staff of the
Congressional Budget Office who played a critical role in finalizing
the bill.
This is a complicated issue, and H.R. 6 is not going to solve the
public health epidemic or its impact on society at the moment, but it
certainly is a good step. I encourage all of us here in this Chamber
today and in Congress to continue to work together to develop policy
solutions for members of our community who are suffering from this
terrible epidemic.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentlewoman from
Indiana (Mrs. Brooks), and concur in my colleague's comments in praise
of the staff that we worked with to get this done. The gentlewoman has
been a real leader.
Mrs. BROOKS of Indiana. Mr. Speaker, the opioid and heroin crisis
continues to hit Hoosiers hard. Sadly, we haven't turned the tide yet.
It is robbing the futures of Americans in every State in our Nation.
We must support those battling addiction.
I have met with so many Hoosiers battling addiction. I visited
treatment centers and recovery houses like the La Verna Lodge for men
and Ohana House Sober Living for women. I have talked with addicts and
those battling addiction about what is working and what is not working
with different recovery options.
Passing the strong bipartisan bill before us today is critically
important. It will help ensure that more people have better access to
treatments, and we can try to save more lives across this country.
Mr. PALLONE. Mr. Speaker, I yield 4 minutes the gentleman from
Maryland (Mr. Cummings), the ranking member of the Oversight and
Government Reform Committee.
Mr. CUMMINGS. Mr. Speaker, I want to thank Mr. Pallone for yielding,
and for his great work on this legislation.
Mr. Speaker, I rise in support of provisions in this package
reauthorizing and reforming the Office of National Drug Control Policy
to improve coordination of our national response to the drug crisis.
At my request, the bill creates a demand reduction coordinator
position, parallel to the existing interdiction coordinator, to
strengthen demand reduction initiatives, including efforts to expand
treatment.
Among other critical reforms, this legislation also requires ONDCP to
report whether drug control program agency budgets are adequate to
achieve the goals of the National Drug Control Strategy. It requires
the compilation of essential data on overdoses, deaths, and
interdiction in a data dashboard, so the American people have a clear,
accessible picture of the effectiveness of efforts to combat the drug
crisis.
I thank Chairman Gowdy, Chairman Meadows, and Vice Ranking Member
Connolly for working with me to develop legislation that will reform
ONDCP. I thank Chairman Grassley, Ranking Member Feinstein, and Senator
Cornyn for their leadership.
Let me also give special thanks to the committee staff and, I must
say, to the majority and the minority staff. They did a phenomenal job
working hard in conference and throughout this effort. Without their
extraordinary efforts, this legislation would not be in this package
today.
Mr. Speaker, I close with a simple warning. There are a lot of people
suffering. Almost 198 people die a day--a day. Those are the people who
are dying, but there are a lot of people in the pipeline who are in so
much pain, they don't even know they are in pain.
So while the provisions of H.R. 6 are important, without
significantly expanding access to treatment and wraparound services
through long-term, sustained funding, we continue to nibble at the
edges of our national crisis, and the crisis will continue to worsen.
Mr. Speaker, I thank the gentleman for yielding.
Mr. WALDEN. Mr. Speaker, it is my great honor and high privilege to
yield 1 minute to the gentleman from Wisconsin (Mr. Ryan), the Speaker
of the House and my dear friend and classmate from the class of `98.
Mr. RYAN of Wisconsin. Mr. Speaker, I thank the gentleman for
yielding.
Mr. Speaker, I rise today to talk about something that is really
close to all of our hearts. We have reached a point in this country
where opioid overdoses claim more than 100 lives each and every single
day.
Think about that for a moment, more than 100 lives every day. Mothers
and fathers are burying sons and daughters, or in some cases, sons and
daughters are burying mothers and fathers.
I bring this up simply to impart the gravity of the situation, which
makes our response all the more urgent. But while the situation is
certainly grave, that does not mean that we should ever lose hope.
As we have worked on this legislation we will soon send to the
President, we all had to go out and gain an understanding of the facts
on this issue. Everybody on both sides of the aisle spent so much time
on this bill. In doing that, we have gleaned so much understanding.
And that is, after all, how our Republic works. That is what the
people's House does. We learn from our constituents. We hear their
stories. We see the suffering, and then we act.
This is a fantastic moment of people coming together to solve a
problem. I think, in this process, we gained something very special.
Many of us heard the stories from incredible souls who have known
unspeakable loneliness and who struggle with drug addiction. They made
it through to the other side.
We met family members and friends who have known the pain and the
fear that accompanies loving someone wrestling with addiction. Every
one of us knows somebody or is related to somebody who has gone through
this.
We met those who will never again have the chance to see the ones
that they love so much.
Amid the overwhelming darkness, we have gotten to see their spark,
their strength. From this pain has come something more powerful:
resolve and a passion to make sure that others have a safe place to
turn, that this doesn't happen to their family.
Witnessing this kind of strength, witnessing this kind of resilience,
that is what helped produce this legislation. Through these bills, we
are trying to ensure that anyone who needs help is not too isolated to
receive it.
We are giving our communities the resources that they need to provide
stronger treatment networks and support systems. That is where the
healing happens. That is where Americans are at our best.
If this legislation can save one life and bring help to one person,
that is what matters.
It is going to do far more than that.
{time} 1100
So I want to thank all of those who were brave enough to share their
stories with all of us. I want to thank all of those people who all of
us met with
[[Page H9246]]
for being brave, for coming here, for meeting us, and for testifying
and giving us their stories. And for all of those who are continuing to
struggle in silence, I want them to know that there is no shame in
their trials. In our own ways, we all fall.
In our Catholic tradition, we look to St. Jude as the patron saint of
lost causes, a keeper of those who some in society may have written
off. To me, his guardianship is written in this legislation. There are
no lost causes. No one is permanently down. It is about offering a
helping hand, and it is about opening our hearts.
Mr. Speaker, I am very proud of this legislation. I am so thankful to
my colleagues on both sides of the aisle who came together to put these
families and to put these communities first.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from New
York (Mr. Tonko), a member of the committee.
Mr. TONKO. Mr. Speaker, I thank the gentleman for yielding.
Mr. Speaker, all across my district, I have encountered stories of
individuals and families whose lives have been irrevocably changed by
the scourge of the opioid epidemic: a father who lost his daughter too
young and is pouring his grief into advocacy, a former neighbor and a
dad who left behind two young children, a young man who is walking the
hard path of recovery and showing others how to do the same.
These are the stories I hear day in and day out. They fill my heart;
they fill my voice. And it is because of them that I am so very proud
to cast a vote in favor of H.R. 6 today. It is my hope that this
legislation will be another small step for our Nation on its road of
recovery from this epidemic.
I am particularly proud that this bill incorporates legislation that
I have introduced, along with my good friend Representative Ben Ray
Lujan of New Mexico, which will provide a meaningful expansion to high-
quality addiction treatment by allowing additional healthcare
providers, such as nurse midwives, to prescribe buprenorphine, a
medication-assisted treatment for opioid use disorder.
In addition, this provision will make permanent buprenorphine-
prescribing authority for nurse practitioners and physician assistants
and allow certain providers to treat more patients in the first year of
their license.
These changes will make a big difference for individuals struggling
from addiction across our country, especially in rural areas, and for
vulnerable populations like pregnant and postpartum women and the
13,000 babies born each year with neonatal abstinence syndrome.
I also want to highlight the inclusion of my Medicaid Reentry Act
into this bill, which aims to improve care for individuals who are
leaving jail or prison and reentering a community setting.
The SPEAKER pro tempore (Mr. Jody B. Hice of Georgia). The time of
the gentleman has expired.
Mr. PALLONE. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from New York.
Mr. TONKO. These individuals are highly vulnerable to opioid overdose
due to lack of effective addiction treatment while incarcerated. By
passing this legislation, we will allow States to engage in
demonstration projects to improve medical care and transition-related
services to Medicaid-eligible incarcerated individuals in the 30 days
prior to their release, reducing the risk of overdose as individuals
are coming back into the community for a second chance. I truly believe
that this provision will transform lives.
I thank Ranking Member Pallone, Chairman Walden, and their staffs for
their continued efforts in this process. Without their dedicated,
bipartisan work, we would not be making this progress today.
Mr. Speaker, I urge my colleagues to support H.R. 6.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from Texas (Mr. Burgess). The country is well served by his
chairmanship of the Subcommittee on Health.
Mr. BURGESS. Mr. Speaker, I thank the gentleman for yielding.
Mr. Speaker, H.R. 6 is by far the most comprehensive legislation to
address this national crisis. While more work remains--and I am the
first to admit it--it provides meaningful solutions and vital resources
for our States and localities.
Many of the priorities developed by the Energy and Commerce Committee
are included in H.R. 6, like the 21st Century Tools for Pain and
Addiction Treatment Act, partially repealing the institutions for
mental disease exclusion and strengthening interagency coordination at
our international mail facilities so that, perhaps, once and for all,
we can do something about this poison coming into our country from
eastern Asia to the detriment of our citizens.
I believe H.R. 6 could have been stronger. It could have included
language aligning 42 CFR Part 2 with HIPAA. That stand-alone bill
received 357 votes in this House. And I promise you, you will see it
again. I am concerned about expanding prescriptive authority for
nonphysicians, and I hope we will be able to look at that again in the
future.
But I cannot let the perfect be the enemy of the good. I urge our
Members to support this product today.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Michigan (Mrs. Dingell), also a member of the committee.
Mrs. DINGELL. Mr. Speaker, I thank Ranking Member Pallone for
yielding and Chairman Walden for his leadership in bringing this bill
to the floor.
Mr. Speaker, I rise in strong support of H.R. 6, the SUPPORT for
Patients and Communities Act. This is a critical first step in
addressing the opioid epidemic.
I have lived on all sides of this. I lived in a home with a father
who was an opioid addict before anyone knew what it was. I had a sister
who died of a drug overdose. Yet I also live with a man who has very
serious chronic pain and needs opioids to live his life comfortably.
We cannot let the pendulum swing too far in either direction, and we
cannot be denying medication to those who need it. I am confident that
this legislation strikes the right balance.
This bill has four provisions which I authored included in it:
The ACE Research Act, which I cosponsored with my friend Mr. Upton,
will spur innovative research into nonopioid pain medications at NIH
and will help lead the next big breakthrough and bring benefits to
patients. We need nonaddictive pain drugs.
I am also pleased that Jessie's Law, which I have worked on for years
with Mr. Walberg, is in this. This provision, which is named after a
young woman we lost far too soon, would require HHS to establish best
practices to ensure that medical professionals have full knowledge of
their patient's opioid history.
The Safe Disposal of Unused Medication Act fixes a critical gap in
our laws by permitting hospice employees from disposing of unused
opioids after a patient has passed away or the medication is no longer
needed.
Finally, I was pleased to work on language with Dr. Bucshon to ensure
that the Welcome to Medicare wellness exam includes a review of the
beneficiary's current opioid prescriptions and screening for potential
substance use disorder.
As we pass this legislation to combat this epidemic which has claimed
so many lives, we cannot forget the 25 million people who do live in
pain. We cannot let the pendulum go either way.
Mr. WALDEN. Mr. Speaker, it is now my privilege to yield 30 seconds
to the gentleman from Ohio (Mr. Latta), the very effective chairman of
our Digital Commerce and Consumer Protection Subcommittee.
Mr. LATTA. Mr. Speaker, I thank the gentleman for yielding.
Mr. Speaker, I rise today in support of H.R. 6. This legislation will
make a significant difference to tens of thousands of Americans who are
struggling with addiction.
I am pleased that my bill, the INFO Act, is part of the fight against
the opioid crisis. The INFO Act is essential to ensuring we are
providing behavioral health professionals, advocates, physicians, and
families with the tools, resources, and funding information they need
to prevent, identify, and treat addiction.
Furthermore, H.R. 6 is critically important to stop the flow of
illegal opioids, prevent the misuse of drugs, and help those who are
addicted. With 190 Americans dying every day from overdoses, it is time
to act now.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Texas
[[Page H9247]]
(Mr. Gene Green), the ranking member of our Health Subcommittee.
Mr. GENE GREEN of Texas. Mr. Speaker, I thank the ranking member for
yielding to me.
Mr. Speaker, I rise in support of the SUPPORT for Patients and
Communities Act, bipartisan legislation that will help stem the tide
against the Nation's opioid crisis and support Americans overcoming
opioid addiction.
In 2016 alone, 42,000 Americans died from opioids, including
prescription pain relievers and illicit opioids like fentanyl. This is
a serious national crisis that affects public health and the social and
economic welfare of communities throughout our great country.
The Energy and Commerce Health Subcommittee, which I am proud to
serve on as ranking member, held several hearings on the opioid crisis
last spring. I am proud to see our committee and both Chambers of
Congress come together and support the package before us today that
includes the Comprehensive Opioid Recovery Centers Act that I
introduced, along with my friend Representative Brett Guthrie from
Kentucky, earlier this year.
This legislation would fund designated treatment centers where
Americans suffering from opioid abuse can receive comprehensive
patient-centered care. The bill would allow designated treatment
centers to provide wraparound services, including mental health,
counseling, recovery housing, and job training and placement to support
reintegration into the workforce. These wraparound services have been
shown to help many Americans successfully overcome opioid addition.
The SUPPORT for Patients and Communities Act includes several
provisions to combat this crisis, including strengthening the Federal
Government's authority to restrict illegal drugs entering our country,
and providing Medicaid for at-risk youth and former foster children.
Mr. Speaker, I ask my colleagues to join me and support this
important legislation.
Mr. WALDEN. Mr. Speaker, I am privileged to yield 30 seconds to the
gentleman from New Jersey (Mr. Lance).
Mr. LANCE. Mr. Speaker, I rise in strong support of H.R. 6, which
delivers greater resources, treatment, and mitigation tools to fight
opioid addiction.
I am especially pleased that a bill that I sponsored related to
infectious diseases is included in the final package. I commend the
Congressman from Massachusetts, Mr. Joe Kennedy, for being my lead
cosponsor on this part of the overall whole.
Infectious diseases complicate the lifelong path toward addiction
recovery. H.R. 6 is one of the most important measures to pass this
Congress. It should be supported unanimously.
Mr. PALLONE. Mr. Speaker, may I inquire as to how much time remains
on each side.
The SPEAKER pro tempore. The gentleman from New Jersey has 3 minutes
remaining.
Mr. PALLONE. Mr. Speaker, I yield 1 minute to the gentleman from New
Mexico (Mr. Ben Ray Lujan).
Mr. BEN RAY LUJAN of New Mexico. Mr. Speaker, I rise today in support
of H.R. 6, the SUPPORT for Patients and Communities Act.
This is an important step forward in the fight against the Nation's
opioid epidemic. However, this Congress must acknowledge that this is
not the end.
Healthcare is a right, not a privilege. There is much more work to do
to ensure that families get the help that they deserve.
I am pleased that this package includes language that I have
championed to address gaps in prevention and gaps in access to
treatment. In addition, this bill will create pathways to behavioral
healthcare jobs in communities like New Mexico.
Still, Congress must do more. As we have heard from Representative
Cummings, this is going to take much more money, investment, and
comprehensive legislation.
Mr. WALDEN. Mr. Speaker, I am privileged to yield 30 seconds to the
gentleman from Kentucky (Mr. Guthrie).
Mr. GUTHRIE. Mr. Speaker, I rise in support of the SUPPORT for
Patients and Communities Act.
One of the main things I hear back home is how our Nation's ongoing
opioid crisis has affected either themselves, their loved ones, or
their community.
Mothers, fathers, children, bankers, dentists, bus drivers, or high
school athletes, anyone can fall victim to opioid use disorder. That is
why I am proud to work with my colleagues in support of the act so that
we can help these people who are suffering from this terrible epidemic.
Mr. Speaker, I urge my colleagues to support this critical
legislation so that we can deliver relief to those communities.
{time} 1115
Mr. PALLONE. Mr. Speaker, I yield myself 1 minute.
Mr. Speaker, before we conclude debate, let me just take a moment to
thank everyone for all of their hard work getting this bill across the
finish line.
This bill represents a collection of Member ideas and policies across
the political spectrum. Many people may not know this, but the staff of
the House and Senate committees negotiated this bill in a matter of
weeks, and that is no small feat. It took a lot of effort, long hours
and weekend work to pull this off. It is a product we can all be proud
of.
So let me thank all legislative counsel and CBO for their efforts as
well.
Mr. Speaker, I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Florida (Mr. Bilirakis) to speak about the legislation.
Mr. BILIRAKIS. Mr. Speaker, the SUPPORT for Patients and Communities
Act is the product of a year of hearings and investigations into
America's opioid crisis.
This thoughtful bipartisan legislation will provide more tools to our
communities to help them. I am proud that we included my legislative
efforts to help Medicare beneficiaries, begin reforms to the sober home
industry, and address the problem of patient brokering.
We need to pass this bill and give our constituents the help they
need.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Ohio (Mr. Johnson), who is a leader on this issue.
Mr. JOHNSON of Ohio. Mr. Speaker, today is the culmination of months
of tireless work driven by heartbreaking stories of people whose lives
were destroyed by opioid addiction, and, just as importantly, the
powerful stories of hope and recovery.
I am grateful for the hard work of my colleagues and our Energy and
Commerce staff. I am proud that my legislation to improve how health
professional students are taught to recognize, prevent, and address
addiction, as well as to expand the availability of telehealth and peer
support services for those struggling with addiction is included.
Mr. Speaker, I am looking forward to continuing the hard work ahead
on this very important issue, and I urge support for the bill.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Indiana (Mr. Bucshon), who is a talented physician on our committee.
Mr. BUCSHON: Mr. Speaker, I rise today in support of H.R. 6, the
SUPPORT for Patients and Communities Act.
This bipartisan bill will help our struggling communities to combat
the opioid epidemic by increasing access and improving care to those in
need and preventing new occurrences of opioid misuse and abuse.
Section 2002, which I authored, would provide screening for chronic
pain, address possible non-opioid pain alternatives, and increase early
detection of opioid use disorder in seniors as they enter Medicare.
Mr. Speaker, I am proud to have worked with my colleagues on
solutions to this serious epidemic, and I urge support of H.R. 6.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Michigan (Mr. Walberg) to speak on the measure.
[[Page H9248]]
Mr. WALBERG. Mr. Speaker, I rise today in strong support of this
bipartisan package to address the opioid crisis devastating our
communities.
This legislation includes two provisions authored by myself and my
good friend from Michigan, Congresswoman Debbie Dingell.
One will help safely dispose of unused drugs and prevent their
diversion into the community. The other, Jessie's Law, honors the
memory of Jessie Grubb and will help prevent future overdose tragedies
under medical care.
Mr. Speaker, this critical legislation will help save and rebuild
lives. I urge its passage today, and I look forward to its quickly
advancing to the President's desk.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Georgia (Mr. Carter), who is our resident pharmacist on the Energy and
Commerce Committee.
Mr. CARTER of Georgia. Mr. Speaker, I would like to thank Chairmen
Walden and Burgess for working so hard with our partners across the
aisle as well as across the Capitol to come to a consensus on this
critical legislation necessary to combat the opioid epidemic.
As the only pharmacist currently serving in Congress, I have seen
families saved by pain medications and have seen families torn apart by
the same drugs.
Since this body began tackling the opioid epidemic, I have said there
are three major components to this crisis: prevention, law enforcement,
and treatment.
This legislation touches all three prongs of the opioid crisis with a
number creative solutions in addition to providing offsets to ensure
that solving a public health crisis does not lead to a fiscal one.
This package is not a silver bullet, but as legislators we need to do
everything in our capacity to prevent the addiction and overdoses that
occur every day in the United States.
Mr. Speaker, I would like to thank Chairman Walden and Burgess for
working so hard with our partners across the aisle as well as across
the Capitol to come to a consensus on this critical legislation
necessary to combat the opioid epidemic.
As the only pharmacist in Congress, I have seen families saved by
pain medications and have seen families torn apart by the same drugs.
Since this body began tackling the opioid epidemic, I have said there
are three major parts to the crisis: prevention, law enforcement, and
treatment.
This legislation touches all three prongs of the opioid crisis with a
number of creative solutions in addition to providing offsets to ensure
that solving a public health crisis does not lead to a fiscal one.
I voted for many of these bills when they came before Energy and
Commerce for markup, and once again I want to offer my full support for
this legislation.
I am pleased that this package includes three of my own bills, the
Special Registration for Telemedicine Clarification Act, the Abuse
Deterrent Access Act, and the Empowering Pharmacists in the Fight
Against Opioid Abuse Act.
This package is not a silver bullet--but as legislators we need to do
everything in our capacity to prevent the addiction and overdoses that
occur every day in the United States.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Illinois (Mr. Roskam).
Mr. ROSKAM. Mr. Speaker, what a joy it is to be on the floor today.
What a joy it is to be amongst a group of people who have set aside
partisanship and have come together to address a crisis that is
crushing our constituents. What a joy it is to be a part of the process
and among a group of people who are trying to find common ground.
This is a good day, Mr. Speaker. There is good work that is
happening. I chair the Health Subcommittee, and it was incredible to
see the work that that subcommittee did on the Ways and Means
Committee.
Mr. Speaker, I am pleased to strongly endorse this bill, and I urge
its passage.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I am honored to yield 30 seconds to the
gentleman from Minnesota (Mr. Paulsen), who has worked so hard for
these issues.
Mr. PAULSEN. Mr. Speaker, I am excited to support this legislation.
It is bipartisan.
Minnesotans and those who are on the front lines of the opioid crisis
will be helped, and it will aid the millions of American families who
are affected by this epidemic.
It includes a bipartisan measure that I authored that will help
prevent opioid addiction among seniors by educating them on alternative
pain management treatments, and the proper, safe disposal of
prescription painkillers. It will help more than 90,000 at-risk seniors
from descending into a deadly spiral of addiction.
The end result will be less addiction, fewer overdoses, and safer
Minnesota communities.
Mr. Speaker, I thank the chairman for yielding time.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Ohio (Mr. Renacci) to speak on the measure.
Mr. RENACCI. Mr. Speaker, I rise in support of this legislation which
includes my bipartisan bill, the Strengthening Partnerships to Prevent
Opioid Abuse Act.
The opioid epidemic has hit my home State of Ohio particularly hard,
with thousands of Ohioans dying from drug overdoses every year.
This bill will make it easier for Medicare Advantage Part D drug
plans, and HHS to combat fraud, waste, and abuse and prevent the
overprescribing of opioids to vulnerable seniors.
I would like to thank members of this conference committee as well as
their staff for including my bill in this package and for their hard
work to pass legislation to address the opioid epidemic.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, may I inquire as to how much time each side
has remaining?
The SPEAKER pro tempore. The gentleman from Oregon has 8\1/2\ minutes
remaining. The gentleman from New Jersey has 1\1/2\ minutes remaining.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the distinguished
gentleman from Michigan (Mr. Bishop.)
Mr. BISHOP of Michigan. Mr. Speaker, I rise in strong support of H.R.
6 which will make great strides toward ending the opioid crisis once
and for all.
I am pleased this package includes my bill, the STOP Act, which is
targeted legislation to help stop synthetic opioids like fentanyl and
carfentanil from entering our country through the international mail
system.
I want to make sure I thank all the parents, educators, law
enforcement, emergency response personnel, healthcare professionals,
victims, and those suffering from addiction who have been working with
me to ensure this legislation gets signed into law. Your hard work has
made a real difference.
Mr. Speaker, I also want to thank my colleagues for their support,
and I urge a ``yes'' vote on the underlying bill, H.R. 6.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, few States have been harder hit than
Kentucky in this effort on opioids, a terrible tragedy.
Mr. Speaker, I yield 30 seconds to the distinguished gentleman from
Kentucky (Mr. Barr).
Mr. BARR. Mr. Speaker, on behalf of the families of the Commonwealth
of Kentucky which suffers from the third highest opioid overdose
mortality rate in the Nation, I rise today in support of H.R. 6, and I
thank the chairman for his leadership on this.
This legislation marks a critical investment to help individuals and
families struggling with addiction rise above addiction and transition
back into the workforce.
Specifically, H.R. 6 includes my legislation, the CAREER Act, which
creates a demonstration program to promote evidence-based transitional
housing that pairs recovery support with life skills, workforce
training, and job placement.
I would like to thank the many nonprofits in my home State of
Kentucky for inspiring this legislation.
[[Page H9249]]
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Pennsylvania (Mr. Barletta). There is a lot of enthusiasm for this
legislation, Mr. Speaker. We want to hear from Mr. Barletta about his
thoughts on it. He has been a real leader on it.
Mr. BARLETTA. Mr. Speaker, I rise today in support of H.R. 6 which
includes my bill, the Treating Barriers to Prosperity Act.
The Appalachian region, including much of my home State of
Pennsylvania, has an overdose death rate 65 percent higher than the
rest of the country for people ages 15 to 64.
My legislation will allow communities to use Appalachian Regional
Commission funding for everything from attracting doctors to putting in
broadband for telemedicine. It will spur economic growth in communities
hit hardest by the opioid epidemic, while also helping those struggling
with addiction by breaking down barriers to employment.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentlewoman from
California (Mrs. Mimi Walters) who is from the West Coast and is a real
leader on our committee.
Mrs. MIMI WALTERS of California. Mr. Speaker, I rise in support of
H.R. 6 and the IMD exclusion repeal probation modeled after my bill,
the IMD CARE Act.
I fought to ensure the IMD exclusion repeal was part of this final
agreement because increasing inpatient treatment options is essential
in our fight against the opioid epidemic.
The Orange County Board of Supervisors agrees with leading addiction
treatment groups: the IMD exclusion repeal and the IMD CARE Act are the
most important steps we can take to end drug overdose deaths in Orange
County.
Mr. Speaker, I urge my colleagues to support this legislation to
address this public health crisis.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentlewoman from
Indiana (Mrs. Walorski), who is also a real worker on this legislation,
to speak on the measure.
Mrs. WALORSKI. Mr. Speaker, I rise today in support of H.R. 6, the
SUPPORT for Patients and Communities Act. It includes my bill, named
for Dr. Todd Graham, who was senselessly murdered last year over an
opioid prescription.
With this legislation, we build on Dr. Graham's legacy of treating
patients not only for their pain, but for their underlying causes.
Today we are taking bipartisan action to expand access to nonopioid
alternatives and give our communities better tools to prevent and treat
addiction.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Michigan (Mr. Mitchell).
Mr. MITCHELL. Mr. Speaker, I rise today in support of H.R. 6 as did
my colleagues.
The opioid crisis has impacted nearly every community across this
country, and in order to most effectively combat this crisis, we must
establish a comprehensive response plan.
I am pleased this bill includes a version of my amendment offered in
committee to establish a system to track Federal funding for drug
control efforts, ensuring the government knows exactly where the money
is being spent, how it is being used, and if it is working.
Mr. Speaker, I support this bill, and I ask my colleagues to do so as
well.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, we have heard from doctors, we heard from
pharmacists, and we have heard from many family members. Now we will
hear from somebody who has a distinguished career in law enforcement.
Mr. Speaker, I yield 30 seconds to the gentleman from California (Mr.
Knight) to speak on this legislation.
Mr. KNIGHT. Mr. Speaker, as a police officer and a street cop in
L.A., I have seen the problems that the opioid epidemic has done to our
communities. It has literally destroyed families and hurt our
communities to no end. H.R. 6 is a much-needed display of
bipartisanship to address the ongoing opioid crisis and epidemic.
Many of the issues that have come out of this bill spur development
of national best practices for substance abuse recovery housing and
incorporates my bill, the Eliminating Kickbacks in Recovery Act, to
establish meaningful penalties for profiteering off other people's pain
and addiction through illicit referrals.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 30 seconds to the gentleman from
Virginia (Mr. Brat) to speak on the measure.
Mr. BRAT. Mr. Speaker, I rise today to thank Chairman Brady,
Chairwoman Foxx, and Chairman Walden for addressing opioid and
substance abuse disorders and their work on H.R. 6, the SUPPORT for
Patients and Communities Act. I am grateful to my colleagues for
treating the crisis with the urgency it deserves.
In my district, this crisis has affected way too many. I am also
grateful that my bill, H.R. 5889, the Recognizing Early Childhood
Trauma Related to Substance Abuse Act of 2018 was included in the final
package before us today.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I don't believe I have any other speakers on
my side of the aisle pending, so with that, I reserve the balance of my
time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I do urge support for this legislation. It is a good
bill. It expands access in a number of ways in coverage. But I do also
want to point out that there are limitations to the bill. In other
words, we do need to do a lot more.
{time} 1130
For example, we still haven't expanded Medicaid coverage in many
States. Medicaid coverage is crucial, in terms of providing treatment.
The bottom line is that the treatment infrastructure in our country
is very much inadequate. Many people really do not have access to
treatment in many parts of the country, including my home State.
I want to close by urging everyone to support this bipartisan and
bicameral bill, because it does do a lot. At the same time, I remind my
colleagues that we have a lot more to do if we are going to address
this opioid crisis, which actually is getting worse instead of better.
Mr. Speaker, I yield back the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, before I close, I want to especially thank our staff on
both sides of the aisle for their incredible work. They have worked day
and night, literally, and all through the weekend--also, the folks at
the Congressional Budget Office and Legislative Counsel. But I
especially thank our team: Josh Trent, Kristen Shatynski, Caleb Graff,
Dan Butler, James Paluskiewicz, Danielle Steele, Adam Buckalew, Melissa
Froelich, Bijan Koohmaraie, Ryan Long, Peter Keilty, and Jenn Sherman,
and the whole team at the Energy and Commerce Committee on both sides
of the aisle.
We worked through a lot of difficult issues, issues where we didn't
start on the same side, but we ended on the same page as we listened to
each other, as we listened to our constituents at home.
Seldom are there times when you are legislating that you can say what
you are doing will actually save lives. This is one of those times.
What we are doing here today is saving lives.
We will lift people out of addiction who are trapped there today. We
will prevent people from ending up in that emergency room because they
overdosed. Maybe they will find a better path. We will go after those
who perpetrated this on the country and after those who try to smuggle
in the illicit synthetics and fentanyl that are cut with heroin and
kill our people.
So today's effort is about people like Amanda, who left this world
tragically
[[Page H9250]]
at a very young age through an overdose. And it is about her parents.
It is about Mike and Winnie. It is about Paula, and it is about her
sons and sister. It is about a woman I met in Hermiston who had to
travel 5 hours to find a physician who could oversee her treatment on
Suboxone because nobody was available. We help fix that in this
legislation.
It is about my friends at Winding Waters in Enterprise, Oregon, who I
was with last week, and the sheriff and others, who talked about the
continuing problems and challenges they face and who have given me
great guidance on these and other issues.
From one end of my district to another, from one end of our country
to another, we have all listened. We have heard. Frankly, we have cried
as we have heard the stories of parents who help their children through
addiction, only to drop them off at college and a matter of days later
retrieve a body.
That is what brings us together here today, Mr. Speaker. It is their
stories that are woven deeply into this legislation. It is because of
them that we will make a difference and we will do it right.
We will know that, as we pass this today and the Senate after us,
that more work does remain to be done. We are on a journey together,
though, and we will find solutions.
Mr. Speaker, I thank my colleagues on both sides of the aisle. I
thank our staffs. I thank the American people who have reached out to
us, counseled us, and helped us.
Mr. Speaker, I urge my colleagues to strongly support passage of the
SUPPORT Act. For patients and for communities, H.R. 6 needs to become
law, and it will shortly.
Mr. Speaker, I yield back the balance of my time.
Ms. MAXINE WATERS of California. Mr. Speaker, I rise to support H.R.
6, the SUPPORT for Patients and Communities Act, a bipartisan bill to
address opioid addiction and other forms of substance abuse.
A comprehensive, common-sense, and compassionate approach to
substance use disorders is long overdue. For far too long, many
communities throughout the United States have been devastated by
substance use disorders. However, despite the widespread suffering that
millions of people--particularly African Americans during the crack
cocaine epidemic--endured and still endure today, our federal, state,
and local governments, in many instances, have pursued punitive
measures in lieu of effective solutions to ensure that all communities
can adequately heal from the devastating impacts of addiction.
I am especially pleased that this bill now includes my amendment to
the House version of H.R. 6, which requires the Department of Health
and Human Services (HHS) to conduct a review of the organizations,
government agencies, and other entities that receive federal funding to
provide substance use disorder treatment services. In addition, the
amendment directs HHS to develop, and submit to Congress, a plan to
direct appropriate resources to address the inadequacies in services or
funding identified through the review.
I am also pleased that this bill addresses concerns that I raised
about the opioid legislation in the House that allowed states to use
Medicaid funds to provide treatment to persons with opioid use
disorders in Institutions for Mental Disease (IMDs), but did not allow
similar treatment for persons with other types of substance use
disorders. In order to seriously address substance use disorders in
communities throughout the United States, it is critical that we
include persons who suffer from all types of substance use disorders,
including those that involve alcohol, cocaine, and methamphetamine, as
well as opioids.
I offered an amendment to the legislation in the House aimed at
addressing my concern about the exclusion of non-opioid forms of
substance use disorders from treatment in IMDs. While my amendment was
not accepted, I am pleased that efforts were made to address my
concern. The final version of H.R. 6 allows states to provide Medicaid
coverage in IMDs for persons with all types of substance use disorders
and also includes safeguards to ensure that states do not reduce the
availability of community-based treatment for persons suffering from
substance use disorders.
While I appreciate the work that has been done on many components of
this bill, I still have some important concerns. As the Ranking Member
of the House Committee on Financial Services, which has jurisdiction
over housing programs, I am concerned that this bill falls short when
it comes to providing housing for people with substance use disorders.
The bill includes a provision that creates a new grant program to
provide temporary housing assistance to help people with substance use
disorders, but this new funding will only be available in half of the
states. This will leave the other half of the states continuing to
struggle with the challenges of helping people with substance use
disorders who are in need of housing. Furthermore, this bill does
nothing to address the overly punitive and unfair policies governing
our federal housing programs that create unnecessary barriers to
housing for people who have criminal backgrounds related to substance
use disorders.
I am encouraged that there is bipartisan support for addressing the
housing needs of persons suffering from substance use disorders, but I
am disheartened that Congress continues to fall short in its efforts to
provide comprehensive solutions that will help people suffering from
substance use disorders in every state of the country. As we work to
address the opioid crisis at hand, let's not forget that Congress still
has a lot of work to do in the way of criminal justice reform to
address the ongoing harmful and discriminatory impacts of the war on
drugs era.
Despite these concerns, I believe this bill includes some valuable
bipartisan solutions that represent a step in the right direction. I
urge all of my colleagues to support H.R. 6, and I look forward to
continuing to work with my colleagues to address the scourge of
substance use disorders in communities throughout the United States.
Mr. WALDEN. Mr. Speaker, I include the following letters in the
Record.
Corporate Health Care Coalition,
September 26, 2018.
Hon. Paul Ryan,
Speaker, House of Representatives,
Washington, DC.
Hon. Mitch McConnell,
Majority Leader, U.S. Senate,
Washington, DC.
Hon. Nancy Pelosi,
Minority Leader, House of Representatives,
Washington, DC.
Hon. Charles Schumer,
Minority Leader, House of Representatives,
Washington, DC.
Dear Speaker Ryan, Leader McConnell, Leader Pelosi and
Leader Schumer: The Corporate Health Care Coalition (CHCC) is
writing to commend both the House of Representatives and the
Senate on finalizing the SUPPORT for Patients and Communities
Act (H.R. 6), bipartisan legislation to address the nation's
opioid crisis. CHCC is comprised of companies from varying
industries that compete in the global marketplace and sponsor
health plans for the benefit of our employees and other
beneficiaries. Collectively, CHCC member companies provide
health benefits for nearly 5 million Americans across every
state in the nation.
The depth and devastation associated with the opioid crisis
is being felt by families and communities nationwide. CHCC
therefore applauds lawmakers for working on a bipartisan
basis to reach consensus on H.R. 6, which represents a
critical step forward in providing necessary resources for
treatment and prevention efforts related to opioids.
We urge the House and Senate to pass this important
legislation.
Sincerely,
Corporate Health Care Coalition.
____
[From the First Focus Campaign for Children, Sept. 27, 2018]
Statement: First Focus Campaign for Children Applauds Bipartisan,
Bicameral Agreement on Opioid Legislation
(By Simona Combi)
Washington, D.C., Sept. 27, 2018.--First Focus Campaign for
Children is delighted to see bipartisan agreement on tackling
the opioid addiction epidemic and helping those affected by
it. In June, the House passed H.R. 6, the SUPPORT for
Patients and Communities Act by a vote of 39614. On September
17th, the Senate passed the Opioid Crisis Response Act of
2018 by a vote of 99-1.
``It is crucial that families and foster youth affected by
this devastating crisis get the help they need to overcome
opioid addiction and put their lives back on track,'' said
Bruce Lesley, First Focus president. ``We are particularly
heartened that this bipartisan bill offers substantive help
and hope both sides of the aisle will make children a
priority going forward.''
The opioid crisis affects foster children and youth in two
ways: First, children enter the child welfare and foster
system often as a result of substance abuse by their parents,
and secondly, foster youth who age out of care are at an
increased risk of substance use disorders. We therefore
commend Congress for including numerous provisions in the
bipartisan, bicameral opioid package that will improve the
lives of foster children and youth impacted by the opioid
crisis, including:
Continuous Health Insurance for former foster youth: This
provision, which corrects a glitch in existing law, allows
foster youth who have aged out of care to remain on Medicaid
through age 26, regardless of whether they relocate to other
states. This provision recognizes the critical importance of
health coverage for former foster youth as they transition
into adulthood. Earlier this
[[Page H9251]]
month, First Focus, the State Policy and Advocacy Reform
Center, and FosterClub held a congressional briefing on the
importance of Medicaid to foster children and youth.
Family-Focused Residential Treatment: This provision
promotes family-based residential treatment for substance use
disorders by requiring the HHS Secretary to issue guidance to
states on how they can support such treatment facilities.
Recovery and Reunifying Families: This provision promotes
the replication of effective recovery coach programs to
improve outcomes for children and families in the child
welfare system who are impacted by substance use disorders.
Family-Focused Residential Treatment: This provision
creates a grant program to promote family-based residential
treatment programs, which are critical to helping parents and
families get the treatment they need to overcome addiction.
Plans of Safe Care: This provision provides grants to
states to improve and coordinate their response to ensure the
safety, permanency, and well-being of infants affected by
substance use.
Trauma-Informed Care: This provision gives the Center for
Disease Control (CDC) authority to work with states to
collect and report data on adverse childhood experiences. It
also directs the CDC to form a task force to promote best
practices in treating children impacted by trauma and to
recommend best practices to federal agencies regarding its
coordination and response to substance use disorders and
other forms of trauma that affect children and families.
At-Risk Youth Medicaid Protection: This legislation would
ensure that incarcerated youth are simply suspended, rather
than terminated, from Medicaid while they are incarcerated.
It would require states to automatically restore full
eligibility to youth upon release from incarceration, and to
take any steps necessary to make sure that youth begin
receiving medical assistance benefits immediately.
The Fiscal Year 2019 annual spending bill for the
Departments of Labor, Health and Human Services, Education
and Related Agencies (H.R. 6157) includes $3.8 billion for
combatting the opioid crisis, and the bill should be signed
into law soon. Adequate federal funding for these new
programs benefitting our foster children is critical. Looking
ahead to Fiscal Year 2020, though, these gains for our
children could be jeopardized if Congress fails to lift the
budget cap for non-defense discretionary spending established
by the 2011 Budget Control Act. If budget caps are allowed,
this type of spending will go down by $55 billion. Congress
must prioritize children in our federal budget decisions.
Mr. WALDEN. Mr. Speaker, I include the following letters in the
Record.
American Benefits Council,
Washington, DC, September 27, 2018.
Hon. Mitch McConnell,
Majority Leader, U.S. Senate,
Washington, DC.
Hon. Chuck Schumer,
Minority Leader, U.S. Senate,
Washington, DC.
Hon. Paul Ryan,
Speaker, House of Representatives,
Washington, DC.
Hon. Nancy Pelosi,
Minority Leader, House of Representatives,
Washington, DC.
Dear Leader McConnell, Leader Schumer, Speaker Ryan and
Leader Pelosi: The American Benefits Council (the Council)
supports the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment (SUPPORT) for Patients and
Communities Act (H.R. 6). We urge Congress to approve this
measure as an important step toward addressing the nation's
opioid addiction crisis.
The Council is a public policy organization representing
principally Fortune 500 companies and other organizations
that assist employers of all sizes in providing employee
benefits. Collectively, the Council's members sponsor
directly or provide services to retirement and health plans
covering over 100 million Americans.
The opioid epidemic has touched workers and families across
the country and employers have been on the front lines of
this battle, striving to stem the tide of prescription drug
abuse through innovative plan design and outreach. A Kaiser
Family Foundation analysis found that the use of prescription
opioids among people with employer-based health coverage
declined in 2016 to its lowest levels in over a decade.
Nevertheless, the annual cost of treating addiction and
overdoses has increased more than eight-fold since 2004, from
$0.3 billion dollars to $2.6 billion in 2016, and pain-
related conditions have resulted in up to $635 billion in
medical costs and lost productivity for employers.
H.R. 6 makes a number of important improvements to current
law by reducing the use and supply of opioids, encouraging
recovery, supporting caregivers and families and driving
innovation and long-term solutions to the opioid addiction
epidemic. The bill also imposes tighter control on opioid
prescription and treatment under the Medicare and Medicaid
programs while also clarifying FDA regulation of nonaddictive
pain and addiction therapies and allowing for more
flexibility with respect to medication-assisted treatment.
We are particularly pleased that the conference committee
wisely excluded from the bill a harmful, unrelated provision
that would have revised the Medicare secondary payer rules to
require private insurers--including employer plans--to pay
for an additional three months of care for end-stage renal
disease (ESRD) patients before Medicare assumes
responsibility for the payments.
The Council strongly opposed this provision, as employers
already shoulder significant costs for workers and family
members and should not be required to bear unrelated
additional costs by expanding the length of time plans must
cover ESRD.
We applaud Congress for developing legislation that will
make America healthier, including many of the 181 million
people covered by employer-provided health plans.
Sincerely,
James A. Klein,
President.
____
[From the National Association for Behavioral Healthcare]
NABH Applauds Congress for Reaching Agreement on Opioid-Response
Package
Washington, D.C., Sept. 26, 2018.--On behalf of more than
1,000 mental health hospitals and addiction treatment
centers, the National Association for Behavioral Healthcare
thanks Congress for reaching an agreement to address
America's deadly opioid crisis.
The final package includes many NABH-supported measures and
contains the first substantive change to the Medicaid
program's burdensome Institutions for Mental Diseases (IMD)
exclusion since the early 1970s.
``NABH thanks House Energy and Commerce Chairman Greg
Walden (R-Ore.) for his strong leadership in the House, which
helped ensure that his colleagues paid close attention to the
IMD exclusion, an antiquated regulation that has denied
access to inpatient treatment for those who need it,'' NABH
President and CEO Mark Covall said in a statement. ``We also
thank Reps. Mimi Walters (R-Calif.) and Paul Tonko (D-N.Y.)
and Sens. Rob Portman (R-Ohio) and Ben Cardin (D-Md.) for
their tireless efforts to understand the IMD exclusion--and
do all they can to repeal this provision and remove access
barriers to behavioral healthcare services for millions of
Americans.''
NABH is also pleased with several other provisions in the
final package and urges lawmakers to pass this legislation as
soon as possible. Lives depend on it.
____
National Association of
Community Health Centers,
September 27, 2018.
Hon. Mitch McConnell,
Senate Majority Leader,
Washington, DC.
Hon. Paul Ryan,
Speaker of the United States House of Representatives,
Washington, DC.
Hon. Chuck Schumer
Senate Minority Leader,
Washington, DC.
Hon. Nancy Pelosi,
Minority Leader of the United States House of
Representatives, Washington, DC.
Dear Senators McConnell and Schumer and Representatives
Ryan and Pelosi: The National Association of Community Health
Centers (NACHC) appreciates Congress' ongoing efforts and
dedication to addressing the opioid crisis, and is pleased to
offer our support for H.R. 6, SUPPORT for Patients and
Communities Act, and urge all House and Senate members to
pass this important legislation.
NACHC is the national membership organization for federally
qualified health centers (also known as FQHCs or ``health
centers''). Health centers play a critical role in the health
care system, serving as the health home for over 28 million
people, the majority of whom live under the Federal Poverty
Level. With over 11,000 sites nationwide, FQHCs provide
affordable, high quality comprehensive primary care to
medically underserved individuals, regardless of their
insurance status or ability to pay.
Substance use disorder (SUD), including opioid use disorder
(OUD), is a top public health concern in the United States,
and health centers have firsthand knowledge of the
consequences. As opioid use disorder has become more
prevalent, health centers are on the frontlines working to
address the comprehensive needs of people at risk of
developing SUD, as well as assisting those who are in need of
treatment for existing SUD/OUD. From 2010 to 2017, health
centers experienced a five-fold increase in patients
receiving treatment for opioids or other substance abuse
disorders. Since 2010, health centers have more than doubled
their behavioral health workforce because of the increased
demand for services, with 3,000 health center providers now
authorized to provide Medication-Assisted Treatment (MAT.) In
fact, in 2017, nearly 65,000 health center patients received
MAT from health center providers.
Health centers stand ready to serve their patients who are
struggling with substance use disorder but there is a clear
need for additional support and policy changes to enable them
to do so more effectively.
We appreciate Congress' consideration of a multitude of
critical policy issues in its response to the opioid
epidemic, including several provisions included in H.R. 6 to:
bolster the SUD workforce, including through new loan
repayment opportunities for SUD providers
[[Page H9252]]
create comprehensive opioid recovery centers (CORCs)
Improve access to telehealth services
Streamline Medicaid coverage for incarcerated youth and
former foster youth
Ensure mental health parity for pregnant women and children
within the CHIP program
Codify MAT prescribing regulations allowing Nurse
Practitioners and Physician Assistants to prescribe
buprenorphine as well as increased flexibility for patient
caps, and allowing additional advanced practice nurses to
prescribe for a period of 5 years
We particularly want to highlight our strong support for
Section 6083 of the bill, which authorizes $8 million to
support expanded access to MAT at FQHCs and rural health
clinics under the Medicare program. We believe this provision
will be of great assistance to health centers who are
initiating and expanding opioid use disorder treatment
programs in underserved areas across the country.
Thank you again for all your hard work to bring this bill
to fruition. We know there is more work we can do together to
turn the tide on this public health crisis and look forward
to continuing to work with you to address the needs of
communities across the country.
Sincerely,
Tom Van Coverden,
President and CEO of NACHC.
Mr. WALDEN. Mr. Speaker, I include the following letters in the
Record.
September 26, 2018.
To The Members of the U.S. House of Representatives: The
U.S. Chamber of Commerce strongly supports the bipartisan
H.R. 6, the ``Opioid Crisis Response Act of 2018.'' The
Chamber will consider including votes related to this bill in
our annual How They Voted scorecard.
The opioid epidemic is ravaging families and destroying the
lives of thousands each year, and it is crippling
communities' and employers' efforts to staff workforce needs,
create new jobs, and expand commerce.
We applaud Congress for crafting comprehensive legislation
to tackle the myriad of causes, such as the flood of illicit
drugs into the United States, while removing a litany of
barriers that inhibit prevention, recovery, and treatment
options.
The Chamber is pleased that H.R. 6 does not include the end
stage renal disease (ESRD) provision included in an earlier
version of the bill. That policy would have burdened
employers already struggling to provide robust health
benefits with hundreds of millions of dollars in additional
health care costs.
While H.R. 6 is important, more remains to be done. The
Chamber urges Congress to address the 42 CFR Part 2 statute
as hundreds of health care organizations have called for.
Congress should align currently conflicting protections and
allow providers access to a patient's entire medical record,
including substance use disorder information, at a patient's
request.
We urge you to support H.R. 6.
Sincerely,
Suzanne P. Clark,
Senior Executive Vice President,
U.S. Chamber of Commerce.
____
Advocates for Opioid Recovery (e-mail)
Medicare beneficiaries have the highest and fastest growing
rate of opioid use disorder (OUD), with more than 300,000
Medicare beneficiaries having been diagnosed with OUD.
However, Medicare does not cover the most cost effective,
evidence-based treatment modality--opioid treatment programs
(OTPs).
OTPs are highly-regulated, highly-effective, comprehensive
treatment programs that provide Medication-Assisted Treatment
(MAT)--the combination of medication with behavioral therapy
and support, and the most effective solution to treat OUD.
There are roughly 1,500 OTPs across the United States
providing treatment to approximately 400,000 patients. These
programs are certified by the Substance Abuse and Mental
Health Services Administration (SAMHSA).
Studies have shown that people who receive MAT are 75
percent less likely to have an addiction-related death than
those who do not receive MAT. Most patients in OTPs are
currently treated with methadone, which can only be used for
treatment of addiction through a licensed OTP.
America's seniors and people with disabilities deserve
better. As your constituent, I encourage you to vote for H.R.
6, which would permanently expand Medicare coverage of OTPs.
For more information about why congressional action is
necessary, visit Advocates for Opioid Recovery's website at
opioidrecovery org.
____
Catholic Health Association
of the United States,
Washington, DC, September 26, 2018.
U.S. House,
Washington, DC.
U.S. Senate,
Washington, DC.
On behalf of the Catholic Health Association of the United
States (CHA), the national leadership organization of more
than 2,000 Catholic health care systems, hospitals, long-term
care facilities, sponsors, and related organizations, I
commend the members of the House and Senate for approving
their versions of legislation to address the nation's opioid
crisis and to urge your support for the final bill, the
Support for Patients and Communities Act (HR 6).
Catholic health providers recognize that each human life is
sacred and possesses inalienable worth, and that health care
is essential to promoting and protecting the inherent dignity
of every individual. We also recognize that supportive and
readily available substance use disorder (SUD) treatments are
essential facets of holistic, person-centered and effective
health care. The first principle in our Vision for U.S.
Health Care affirms our call to pay special attention to
those most likely to lack access to health care, many of whom
are in desperate need of SUD services. This commitment is why
the Catholic health ministry strongly supports efforts to
increase access to these services and ensure that they become
fully integrated into our health care system.
CHA has supported many of the provisions included in HR 6,
particularly those that would increase access to care under
Medicaid and care for such vulnerable populations as children
and pregnant women, as well as provisions to increase the use
of telehealth services. We are particularly pleased that the
final version of this legislation includes the IMD Care Act,
to provide state Medicaid programs with the option to cover
care during FY2019-23 in certain Institutions for Mental
Diseases (IMD) that may be otherwise non-federally-
reimbursable under the IMD exclusion. We are also pleased
that the bill includes measures to ensure access to mental
health and substance use disorder services for children and
pregnant women under the Children's Health Insurance Program
(CHIP).
However, we are disappointed that legislation introduced in
the Senate (S. 1850, the Protecting Jessica Grubb's Legacy
Act) and overwhelmingly approved in the House (HR 6082) to
align current regulations for SUD treatment records with
existing patient protections under HIPAA for treatment,
payment and health care operations was not included in HR 6.
For health providers, the alignment of SUD records with other
medical records is essential to providing whole-person care.
It enables the essential flow of patient information among
providers that is critical to the timely and effective
delivery of health care and critical to patient safety and
quality. Given the broad and bipartisan support for HR 6082,
we continue to urge the Senate to approve this bill as well
before the end of the 115th Congress.
Thank you again for your attention to the urgent matter of
opioid and other substance use disorders. We know that you
share the goal of our Catholic health ministry in providing
the best possible care and treatment for those who need it,
and we hope approval of the Support for Patients and
Communities Act will provide effective additional resources
for doing so.
Sincerely,
Sr. Carol Keehan, DC,
President and CEO.
Mr. WALDEN. Mr. Speaker, I include the following letters in the
Record.
[From the American Society of Addiction Medicine]
Rockville, MD, September 26, 2018.
American Society of Addiction Medicine Applauds Inclusion of Key
Provisions in Historic Opioid Legislative Package
Key Provisions to Teach, Standardize, and Cover Addiction Medicine Will
Help Close Treatment Gap and Save Lives, Addiction Medicine Experts Say
The American Society of Addiction Medicine (ASAM) today
applauds US House and Senate leaders for announcing a
bipartisan agreement on an opioid legislative package that
includes key provisions to bolster the country's addiction
treatment workforce, help provide standardized evidence-based
treatment for individuals with a substance use disorder
(SUD), and help ensure coverage and payment models facilitate
comprehensive, coordinated care for patients seeking
treatment for a SUD.
``On behalf of America's addiction medicine physicians and
other clinicians on the frontlines of this crisis, ASAM
applauds our Congressional leaders for working together to
include key provisions that will help close the current
treatment gap, bolster the addiction medicine workforce, and
save more lives,'' said Kelly J. Clark, MD, MBA, DFASAM,
president of ASAM. ``Reversing course on the deadly opioid
overdose crisis requires bold policy solutions that help
teach, standardize, and cover addiction medicine so more
patients benefit from evidence-based treatment. The agreement
reached last night is an important step toward realizing this
critical goal.''
Key provisions in the legislative package to teach,
standardize, and cover evidence-based addiction medicine
include:
Making permanent buprenorphine prescribing authority for
physician assistants and nurse practitioners and allowing
waivered practitioners to treat immediately up to 100
patients at a time (in lieu of 30) if the practitioner is
board certified in addiction medicine or addiction
psychiatry; or if the practitioner provides medication
assisted treatment (MAT) in a qualified practice setting.
Certain qualified physicians would also be allowed to treat
up to 275 patients at a time with buprenorphine, codifying an
existing rule;
Allowing physicians who have recently graduated in good
standing from an accredited school of allopathic or
osteopathic medicine, and who meet the other training
requirements during school to prescribe MAT, to obtain a
waiver to prescribe MAT;
[[Page H9253]]
Providing loan repayment relief to addiction treatment
professionals who practice in high-need areas;
Creating a Medicare demonstration program to increase
access to evidence-based outpatient treatment for
beneficiaries with opioid use disorder that includes
medication as well as psychosocial supports, care management,
and treatment planning;
Partially repealing the Institutions for Mental Diseases
(IMD) exclusion and allowing state Medicaid programs to cover
care in certain IMDs that can deliver services consistent
with certain requirements, including evidence-based
assessments and levels of care;
Directing the Departments of Justice and Health and Human
Services to finalize special registration regulations
concerning the prescribing of medications for addiction via
telemedicine within one year of enactment;
Expanding Medicare coverage to include payment for Opioid
Treatment Programs through bundled payments for wholistic
services;
Convening a stakeholder group to produce a report of best
practices for states to consider in health care related
transitions for inmates of public correctional facilities;
and
Requiring the Substance Abuse and Mental Health Services
Administration (SAMHSA) to provide information to SAMHSA
grantees to encourage the implementation and replication of
evidence-based practices.
``Substance use disorder is both treatable and
preventable--but from where we stand today, delivering high-
quality care to the millions of Americans who live with the
disease of addiction will require significant investments in
our workforce, coverage, and payment models that facilitate
coordinated and comprehensive care, and structural changes
that incentivize the use of evidence-based approaches,'' said
Clark. ``And while we celebrate this bipartisan announcement
today, ASAM knows there is still much more work to be done to
ensure all Americans living with a substance use disorder get
the treatment they need. ASAM will continue to advocate for
building an addiction treatment system that fully integrates
mental health, substance use disorder, and primary care
services in order to produce the best patient outcomes. This
includes supporting final passage of legislation that would
more closely align 42 CFR Part 2 with the Health Insurance
Portability and Accountability Act.''
For more information about the American Society of
Addiction Medicine, please visit www.ASAM.org.
____
September 27, 2018.
Hon. Mitch McConnell,
Majority Leader, U.S. Senate, Washington, DC.
Hon. Chuck Schumer,
Minority Leader, U.S. Senate, Washington, DC.
Hon. Paul Ryan,
Speaker of the House,
House of Representatives, Washington, DC.
Hon. Nancy Pelosi,
Minority Leader,
House of Representatives, Washington. DC.
Dear Majority Leader McConnell, Minority Leader Schumer,
Speaker Ryan and Minority Leader Pelosi: We the undersigned,
representing the major groups across all disciplines working
on a comprehensive response to address addiction, write in
support of the final conference agreement of the Substance
Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act (H.R. 6)
and urge for quick passage of this package.
As you know, the Centers for Disease Control and Prevention
recently reported that more than 72,000 Americans died of a
drug overdose in 2017, a staggering increase from 63,600 in
2016. With nearly 200 Americans dying each day as a result of
drug overdose, the opioid crisis is an urgent and serious
public health and safety issue that needs to be addressed
through a comprehensive response.
We are grateful to Congress for addressing this urgent need
to improve policies and resources to curtail opioid misuse
and to help the millions impacted by addiction nationwide. We
thank Members on both sides of the aisle and the 13
congressional committees for their work to construct this
thoughtful, evidence-based legislation. We strongly support
the SUPPORT for Patients and Communities Act and its
multifaceted, nuanced approach to addressing the opioid
crisis and all substance use disorders.
Key provisions include:
Healthcare Integration
Treatment, Education, and Community Help To Combat
Addiction (Section 7101)--Expands medical education and
training resources for healthcare providers to better address
addiction, pain, and the opioid crisis;
Preventing Overdoses While in Emergency Rooms (Section
7081)--Improves emergency departments ability to effectively
screen, treat, and connect substance use disorder patients
with care;
Alternatives to Opioids in the Emergency Department
(Section 7091)--Explores alternative pain management
protocols in order to limit the use of opioid medications in
emergency departments;
Inclusion of opioid addiction history in patient records
(Section 7051)--Requires HHS to develop best practices for
prominently displaying substance use disorder treatment
information in electronic health records, when requested by
the patient.
Treatment Capacity Expansion
IMD CARE Act (Section 5052)--Expands Medicaid coverage up
to 30 days for individuals between 21 and 65 years old
receiving care in a treatment facility for all substance use
disorders, lifting the 16 bed restriction;
Expansion of Telehealth Services (Section 1009, 2001,
3232)--Expands access to substance use disorder treatment and
other services through the use of telehealth;
Comprehensive Opioid Recovery Centers (Section 7121)--
Establishes model comprehensive treatment and recovery
centers to ensure individuals have access to quality
treatment and recovery services;
Supporting family-focused residential treatment (Section
8081, 8083)--Enhanced family-focused residential treatment;
$20 million in funding for HHS to award to states to develop,
enhance, or evaluate family-focused treatment programs to
increase the number of evidence-based programs.
Treatment Workforce Expansion
Substance Use Disorder Workforce Loan Repayment (Section
7071)--Enhances the substance use disorder treatment
workforce by creating a student loan repayment program for
healthcare professionals;
Addressing economic and workforce impacts of the opioid
crisis (Section 8041)--Awards grants to states to support
substance use disorder and mental health treatment workforce
shortages.
Medication Assisted Treatment
More Flexibility for Prescribing Medication Assisted
Treatment (Section 3201, 3202)--Increases the number of
waivered health care providers that can prescribe or dispense
treatment for substance use disorders, such as certified
nurses and accredited physicians;
Grants to enhance access to substance use disorder
treatment (Section 3203)--Authorizes grants to support the
development of curriculum that will help health care
practitioners obtain a waiver to prescribe MAT;
Delivery of a Controlled Substance by a Pharmacy to be
Administered by Injection or Implantation (Section 3204)--
Allows pharmacies to deliver implantable or injectable
medications to treat substance use disorders directly to
health care providers.
Expanding Access to Medication in In-Patient Facilities
(Section 5052)--Expanded Medicaid coverage up to 30 days for
in-patient facilities applies to providers who provide a
minimum of two types of medicines to treat opioid use
disorder.
Ending Illegal Patient Brokering
Criminal penalties (Section 8122)--This provision makes it
illegal to pay or receive kickbacks in return for referring a
patient to recovery homes or clinical treatment facilities.
Recovery Supports
CAREER Act (Section 7183)--Improves resources and wrap-
around support services for individuals in recovery from a
substance use disorder who are transitioning from treatment
programs to independent living and the workforce;
Ensuring Access to Quality Sober Living (Section 7031)--
Develops and disseminates best practices for operating
recovery housing to ensure individuals are living in a safe
and supportive environment;
Building Communities of Recovery (Section 7151, 7152)--
Awards grants to recovery community organizations to provide
regional training and technical assistance in order to expand
peer recovery support services nationwide;
Improving recovery and reunifying families (Section 8082)--
Provides $15 million to HHS to replicate a ``recovery coach''
program for parents with children in foster care due to
parental substance use.
Prevention
Drug-Free Communities Reauthorization (Section 8203)--
Reauthorizes the Drug-Free Communities Program to mobilize
communities to prevent youth substance use and extends the
National Community Anti-Drug Coalition Institute.
Helping Moms and Babies
Sobriety Treatment and Recovery Teams (START; Section
8214)--Establishes and expands the implementation of the
START program, which pairs social workers and family mentors
with a small number of families, providing peer support,
intensive treatment and child welfare services;
Caring Recovery for Infants and Babies (Section 1007)--
Expands Medicaid coverage for infants with neonatal
abstinence syndrome who are receiving care in residential
pediatric recovery centers;
Health Insurance for Former Foster Youth (Section 1002)--
Allows former foster youth to keep their Medicaid coverage
across state lines until age 26;
Modifies IMD Exclusion for Pregnant and Postpartum Women
(Section 1012)--Allows for pregnant and postpartum women who
are receiving care for substance use disorder in a treatment
facility to receive other Medicaid-covered care, such as
prenatal services;
Report on addressing maternal and infant health in the
opioid crisis (Section 7061)--Studies best practices of pain
management, prevention, identification, and reduction of
opioid and other substance use disorders during pregnancy;
Early interventions for pregnant women and infants (Section
7063)--Develops and disseminates educational materials for
clinicians to use with pregnant women for shared decision-
making regarding pain management during pregnancy;
Prenatal and postnatal health (Section 7064)--Authorizes
data collection and analysis of neonatal abstinence syndrome
and
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other outcomes related to prenatal substance abuse and
misuse, including prenatal opioid abuse and misuse;
Plans of safe care (Section 7065)--Supports states in
collaboration and improving plans of safe care for substance-
exposed infants.
Helping Patients and Families in Crisis
Communication with families during emergencies (Section
7052)--Reminds healthcare providers annually that they are
allowed under current federal privacy laws to notify
families, caregivers, and health care providers of overdose
emergencies involving a loved one;
Families and Patients in Crisis (Section 8212)--Grants to
expand services for patient and families impacted by
substance use disorder and in crisis.
Law Enforcement
Reauthorization of Key Law Enforcement Programs (Section
8205-8212)--Reauthorizes law enforcement programs through the
Office of National Drug Control Policy, such as programs such
as the High Intensity Drug Trafficking Area programs, drug
courts, COPS Anti-Meth Program, and COPS anti-heroin task
force program;
First Responder Training (Section 7002)--Expands first
responder training, authorized through the Comprehensive
Addiction and Recovery Act, to include training on safety
around fentanyl and other synthetic and dangerous substances;
Public Health Laboratories Detecting Fentanyl and Other
Synthetic Opioids (Section 7011)--Improves coordination
between public health laboratories and laboratories operated
by law enforcement to improve detection of fentanyl and other
synthetic opioids;
Synthetics Trafficking and Overdose Prevention (Section
8006, 8007)--Improves Federal agencies ability to detect
synthetic opioids and other substances from entering the
United States through the mail;
Opioid Addiction Recovery Fraud Prevention (Sections 8021-
8023)--Subjects those who engage in unfair or deceptive acts
with respect to substance use disorder treatment services or
substance use disorder treatment products to civil penalties
for first time violations by the FTC; includes a savings
clause for existing FTC and FDA authorities;
Reauthorization of the comprehensive opioid abuse grant
program (Section 8092)--Reauthorize the comprehensive opioid
abuse grant program at the Department of Justice.
Prescription Medication Safety and Disposal
Empowering Pharmacists in the Fight Against Opioid Abuse
(Section 3212)--Develops and disseminates training resources
to help pharmacists better detect fraudulent attempts to fill
prescription medications;
Safe Disposal of Unused Medication (Section 3222)--Allows
hospice workers to dispose of unused medications on site or
in patients homes;
Access to Increased Drug Disposal (Section 3251-3260)--
Awards grants to states to enhances access of prescription
drug disposal programs;
Safety-enhancing Packaging and Disposal Features (Section
3032)--Requires certain opioids to be packaged into 3 or 7
day supplies and requires safe prescription drug disposal
options to be given to patients upon receiving medications.
Prisoner Reentry
Promoting State innovations to ease transitions integration
to the community for certain individuals (Section 5032)--
Requires the HHS Secretary to convene a stakeholder group to
produce a report of best practices for states to consider in
health care related transitions for inmates of public
institutions.
We commend Congress for its leadership and the bipartisan,
bicameral work it has undertaken to address the ever
worsening opioid crisis. We are pleased that this package
contains a truly comprehensive approach to addressing the
opioid crisis, across the entire continuum of care
prevention, treatment and recovery support. In addition, it
fully recognizes addiction as the medical condition that it
is and contains meaningful programs aimed at helping patients
and families struggling with this disease. For all of these
reasons, we urge the quick passage of the final agreement of
the SUPPORT for Patients and Communities Act (H.R. 6).
Sincerely,
1. A New PATH, San Diego, California
2. Addiction Policy Forum
3. AIDS United
4. Alabama, Addiction Policy Forum
5. Alaska, Addiction Policy Forum
6. American Correctional Association
7. Arizona, Addiction Policy Forum
8. Association of Prosecuting Attorneys
9. Beyond Addiction Ministry, WI
10. Brave Health
11. CADA of Northwest Louisiana
12. California Consortium of Addiction Programs &
Professionals (CCAPP)
13. California, Addiction Policy Forum
14. Campaign for Youth Justice
15. Caron Treatment Centers
16. CFC Loud N Clear Foundation, Farmingdale, New Jersey
17. Chicago Recovering Communities Coalition, Chicago,
Illinois
18. Colorado, Addiction Policy Forum
19. Community Anti- Drug Coalitions of America (CADCA)
20. Connecticut Certification Board
21. Connecticut Community for Addiction Recovery (CCAR),
Hartford, Connecticut
22. Connecticut, Addiction Policy Forum
23. COPES
24. DarJune Recovery Support Services & Cafe, Green Bay,
Wisconsin
25. Delaware, Addiction Policy Forum
26. Delphi Behavioral Health Group
27. DisposeRx
28. El Paso Alliance, El Paso, Texas
29. Faces & Voices of Recovery
30. FAVOR Low Country, Charleston, South Carolina
31. FAVOR Tri-County, Rock Hill, South Carolina
32. FedCURE
33. Fellowship Foundation Recovery Community Organization,
Margate. Florida
34. Floridians for Recovery, West Palm Beach, Florida
35. Foundation for Recovery, Las Vegas, Nevada
36. Friends of Emmett
37. H.O.P.E.S. Forever
38. Healthcare Leadership Council
39. IC & RC
40. Idaho, Addiction Policy Forum
41. Illinois Association of Behavioral Health
42. Illinois, Addiction Policy Forum
43. Indiana, Addiction Policy Forum
44. Institute for Behavior and Health (IBH)
45. Iowa, Addiction Policy Forum
46. Jackson Area Recovery Community, Jackson, Michigan
47. Kansas, Addiction Policy Forum
48. Kentucky, Addiction Policy Forum
49. Kingston NH Lions Foundation
50. Lifehouse Recovery Connection, San Diego, California
51. Maine Alliance for Addiction Recovery, Augusta, Maine
52. Maine, Addiction Policy Forum
53. Maryland House Detox
54. Maryland, Addiction Policy Forum
55. Massachusetts, Addiction Policy Forum
56. Michigan, Addiction Policy Forum
57. Minnesota Recovery Connection, Minneapolis, Minnesota
58. Minnesota, Addiction Policy Forum
59. Missouri Recovery Network, Jefferson City, Missouri
60. Missouri, Addiction Policy Forum
61. Montana, Addiction Policy Forum
62. National Association of Social Workers (NASW)
63. National Prevention Science Coalition
64. National Safety Council
65. Navigate Recovery Gwinnett, Gwinnett County, Georgia
66. Navigating Recovery of the Lakes Region, Laconia, New
Hampshire
67. Nevada, Addiction Policy Forum
68. New Hampshire, Addiction Policy Forum
69. New Jersey, Addiction Policy Forum
70. New Mexico, Addiction Policy Forum
71. New York, Addiction Policy Forum
72. North Carolina, Addiction Policy Forum
73. North Dakota, Addiction Policy Forum
74. Ohio Citizen Advocates for Addiction Recovery,
Columbus, Ohio
75. Ohio, Addiction Policy Forum
76. Oklahoma, Addiction Policy Forum
77. Oregon, Addiction Policy Forum
78. PEER Wellness Center
79. PEER360 Recovery Alliance, Bay City, Michigan
80. Pennsylvania Recovery Organization, Achieving Community
Together (PRO-ACT), Philadelphia, Pennsylvania
81. Pennsylvania, Addiction Policy Forum
82. People Advocating Recovery, Louisville, Kentucky
83. Phoenix House Recovery Residences
84. PLR Athens, Athens, Georgia
85. Reality Check, Jaffrey, New Hampshire
86. Recover Wyoming, Cheyenne, Wyoming
87. Recovery Communities of North Carolina, Raleigh, North
Carolina
88. Recovery Community Connection, Williamsport,
Pennsylvania
89. Recovery Community of Durham, Durham, North Carolina
90. Recovery Data Solutions
91. Rhode Island, Addiction Policy Forum
92. ROCovery Fitness, Rochester, New York
93. Shatterproof
94. Smart Approaches to Marijuana Action (SAM Action)
95. SMART Recovery, Nationwide
96. Sobriety Matters
97. Solutions Recovery, Oshkosh, Wisconsin
98. South Dakota, Addiction Policy Forum
99. SpiritWorks Foundation, Williamsburg, Virginia
100. Springs Recovery Connection, Colorado Springs,
Colorado
101. Strengthening the Mid-Atlantic Region for Tomorrow
(SMART)
102. Tennessee, Addiction Policy Forum
103. Texas, Addiction Policy Forum
104. The DOOR--DeKalb Open Opportunity for Recovery,
Decatur, Georgia
105. The McShin Foundation, Richmond, Virginia
106. The Moyer Foundation
107. The Phoenix, Nationwide
108. The RASE Project, Harrisburg, Pennsylvania
109. The Solano Project, Fairfield, California
110. Treatment Communities of America
111. Trilogy Recovery Community, Walla Walla, Washington
112. Trust for America's Health
113. Utah, Addiction Policy Forum
114. Vermont, Addiction Policy Forum
115. Virginia, Addiction Policy Forum
116. Voices of Hope Lexington, Lexington, Kentucky
117. Voices of Recovery San Mateo County, San Mateo,
California
118. WAI-IAM, Inc. and RISE Recovery Community, Lansing,
Michigan
[[Page H9255]]
119. Washington, Addiction Policy Forum
120. Washtenaw Recovery Advocacy Project (WRAP), Ann Arbor,
Michigan
121. West Virginia, Addiction Policy Forum
122. Wisconsin Voices for Recovery, Madison, Wisconsin
123. Wisconsin, Addiction Policy Forum
124. Wyoming, Addiction Policy Forum
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Oregon (Mr. Walden) that the House suspend the rules and
agree to the resolution, H. Res. 1099.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. WALDEN. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this motion will be postponed.
____________________