[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Placed on Calendar Senate (PCS)]
<DOC>
Calendar No. 485
115th CONGRESS
2d Session
H. R. 6
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 25, 2018
Received; read the first time
June 26, 2018
Read the second time and placed on the calendar
_______________________________________________________________________
AN ACT
To provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act'' or the ``SUPPORT for Patients and
Communities Act''.
(b) Table of Contents.--The table of contents for 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. Drug management program for at-risk beneficiaries.
Sec. 1005. Medicaid drug review and utilization.
Sec. 1006. 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. 1007. Medicaid health homes for opioid-use-disorder Medicaid
enrollees.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 2001. Authority not to apply certain Medicare telehealth
requirements in the case of certain
treatment of a substance use disorder or
co-occurring mental health disorder.
Sec. 2002. Encouraging the use of non-opioid analgesics for the
management of post-surgical pain.
Sec. 2003. Requiring a review of current opioid prescriptions for
chronic pain and screening for opioid use
disorder to be included in the Welcome to
Medicare initial preventive physical
examination.
Sec. 2004. Modification of payment for certain outpatient surgical
services.
Sec. 2005. Requiring e-prescribing for coverage of covered part D
controlled substances.
Sec. 2006. Requiring prescription drug plan sponsors under Medicare to
establish drug management programs for at-
risk beneficiaries.
Sec. 2007. Medicare coverage of certain services furnished by opioid
treatment programs.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 3001. Clarifying FDA regulation of non-addictive pain and
addiction therapies.
Sec. 3002. Surveillance and Testing of Opioids to Prevent Fentanyl
Deaths.
Sec. 3003. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use
disorders.
Sec. 3004. High-quality, evidence-based opioid analgesic prescribing
guidelines and report.
Sec. 3005. Report on opioids prescribing practices for pregnant women.
Sec. 3006. Guidelines for prescribing naloxone.
Sec. 3007. Requiring a survey of substance use disorder treatment
providers receiving Federal funding.
TITLE IV--OFFSETS
Sec. 4001. Promoting value in Medicaid managed care.
Sec. 4002. Extending period of application of Medicare secondary payer
rules for individuals with end stage renal
disease.
Sec. 4003. Requiring reporting by group health plans of prescription
drug coverage information for purposes of
identifying primary payer situations under
the Medicare program.
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 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.
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. Short title.
Sec. 6022. Provision of information regarding opioid use and pain
management as part of Medicare & You
handbook.
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. Medicare notifications to outlier prescribers of opioids.
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. 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--Stop Excessive Narcotics in Our Retirement Communities
Protection
Sec. 6101. Short title.
Sec. 6102. Suspension of payments by Medicare prescription drug plans
and MA-PD plans pending investigations of
credible allegations of fraud by
pharmacies.
Subtitle L--Providing Reliable Options for Patients and Educational
Resources
Sec. 6111. Short title.
Sec. 6112. Requiring Medicare Advantage plans and part D prescription
drug plans to include information on risks
associated with opioids and coverage of
nonpharmacological therapies and nonopioid
medications or devices used to treat pain.
Sec. 6113. Requiring Medicare Advantage plans and prescription drug
plans to provide information on the safe
disposal of prescription drugs.
Sec. 6114. Revising measures used under the Hospital Consumer
Assessment of Healthcare Providers and
Systems survey relating to pain management.
TITLE VII--OTHER HEALTH PROVISIONS
Subtitle A--Synthetic Drug Awareness
Sec. 7001. Short title.
Sec. 7002. Report on effects on public health of synthetic drug use.
Subtitle B--Empowering Pharmacists in the Fight Against Opioid Abuse
Sec. 7011. Short title.
Sec. 7012. Programs and materials for training on certain circumstances
under which a pharmacist may decline to
fill a prescription.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
Sec. 7021. Short title.
Sec. 7022. Establishment of substance use disorder information
dashboard.
Sec. 7023. Interagency Substance Use Disorder Coordinating Committee.
Subtitle D--Ensuring Access to Quality Sober Living
Sec. 7031. Short title.
Sec. 7032. National recovery housing best practices.
Subtitle E--Advancing Cutting Edge Research
Sec. 7041. Short title.
Sec. 7042. Unique research initiatives.
Subtitle F--Jessie's Law
Sec. 7051. Short title.
Sec. 7052. Inclusion of opioid addiction history in patient records.
Sec. 7053. Communication with families during emergencies.
Subtitle G--Safe Disposal of Unused Medication
Sec. 7061. Short title.
Sec. 7062. Disposal of controlled substances of a deceased hospice
patient by employees of a qualified hospice
program.
Subtitle H--Substance Use Disorder Workforce Loan Repayment
Sec. 7071. Short title.
Sec. 7072. Loan repayment program for substance use disorder treatment
employees.
Subtitle I--Preventing Overdoses While in Emergency Rooms
Sec. 7081. Short title.
Sec. 7082. Program to support emergency room discharge and care
coordination for drug overdose patients.
Subtitle J--Alternatives to Opioids in the Emergency Department
Sec. 7091. Short title.
Sec. 7092. Emergency department alternatives to opioids demonstration
program.
Subtitle K--Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now
Sec. 7101. Short title.
Sec. 7102. Detention, refusal, and destruction of drugs offered for
importation.
Sec. 7103. Notification, nondistribution, and recall of adulterated or
misbranded drug products.
Sec. 7104. Single source pattern of shipments of adulterated or
misbranded drugs.
Sec. 7105. Fund to strengthen efforts of FDA to combat the opioid and
substance use epidemic.
Sec. 7106. Consideration of potential for misuse and abuse required for
drug approval.
Subtitle L--Treatment, Education, and Community Help to Combat
Addiction
Sec. 7111. Short title.
Sec. 7112. Establishment of Regional Centers of Excellence in Substance
Use Disorder Education.
Subtitle M--Guidance From National Mental Health and Substance Use
Policy Laboratory
Sec. 7121. Guidance from National Mental Health and Substance Use
Policy Laboratory.
Subtitle N--Comprehensive Opioid Recovery Centers
Sec. 7131. Short title.
Sec. 7132. Comprehensive opioid recovery centers.
Subtitle O--Poison Center Network Enhancement
Sec. 7141. Short title.
Sec. 7142. Reauthorization of poison control centers national toll-free
number.
Sec. 7143. Reauthorization of nationwide public awareness campaign to
promote poison control center utilization.
Sec. 7144. Reauthorization of the poison control center grant program.
Subtitle P--Eliminating Opioid Related Infectious Diseases
Sec. 7151. Short title.
Sec. 7152. Reauthorization and expansion of program of surveillance and
education regarding infections associated
with illicit drug use and other risk
factors.
Subtitle Q--Better Pain Management Through Better Data
Sec. 7161. Short title.
Sec. 7162. Guidance addressing alternative approaches to data
collection and labeling claims for opioid
sparing.
Subtitle R--Special Registration for Telemedicine Clarification
Sec. 7171. Short title.
Sec. 7172. Deadline for interim final regulations for a special
registration To engage in the practice of
telemedicine.
Subtitle S--Peer Support Communities of Recovery
Sec. 7181. Short title.
Sec. 7182. Building communities of recovery.
Subtitle T--Stop Illicit Drug Importation
Sec. 7191. Short title.
Sec. 7192. Detention, refusal, and destruction of drugs offered for
importation.
Sec. 7193. Seizure.
Sec. 7194. Debarring violative individuals or companies.
Subtitle U--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
Sec. 7201. Short title.
Sec. 7202. Preventing overdoses of controlled substances.
Sec. 7203. Prescription drug monitoring program.
Subtitle V--Securing Opioids and Unused Narcotics With Deliberate
Disposal and Packaging
Sec. 7211. Short title.
Sec. 7212. Improved technologies, controls, or measures with respect to
the packaging or disposal of certain drugs.
Subtitle W--Postapproval Study Requirements
Sec. 7221. Postapproval study requirements.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
Sec. 8001. Short title; table of contents.
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--Recognizing Early Childhood Trauma Related to Substance
Abuse
Sec. 8011. Short title.
Sec. 8012. Recognizing Early Childhood Trauma Related to Substance
Abuse.
Subtitle C--Assisting States' Implementation of Plans of Safe Care
Sec. 8021. Short title.
Sec. 8022. Assisting States with implementation of plans of safe care.
Subtitle D--Improving the Federal Response to Families Impacted by
Substance Use Disorder
Sec. 8031. Short title.
Sec. 8032. Interagency Task Force to Improve the Federal Response to
Families Impacted by Substance Use
Disorders.
Subtitle E--Establishment of an Advisory Committee on Opioids and the
Workplace
Sec. 8041. Establishment of an Advisory Committee on Opioids and the
Workplace.
Subtitle F--Veterans Treatment Court Improvement
Sec. 8051. Short title.
Sec. 8052. Hiring by Department of Veterans Affairs of additional
Veterans Justice Outreach Specialists.
Subtitle G--Peer Support Counseling Program for Women Veterans
Sec. 8061. Peer support counseling program for women veterans.
Subtitle H--Treating Barriers to Prosperity
Sec. 8071. Short title.
Sec. 8072. Drug abuse mitigation initiative.
Subtitle I--Supporting Grandparents Raising Grandchildren
Sec. 8081. Short title.
Sec. 8082. Findings.
Sec. 8083. Advisory Council To Support Grandparents Raising
Grandchildren.
Sec. 8084. Definitions.
Subtitle J--Reauthorizing and Extending Grants for Recovery From Opioid
Use Programs
Sec. 8091. Short title.
Sec. 8092. Reauthorization of the comprehensive opioid abuse grant
program.
TITLE IX--SITSA ACT
Sec. 9001. Short title.
Sec. 9002. Establishment of schedule A.
Sec. 9003. Temporary and permanent scheduling of schedule A substances.
Sec. 9004. Penalties.
Sec. 9005. False labeling of schedule A controlled substances.
Sec. 9006. Registration requirements for handlers of schedule A
substances.
Sec. 9007. Additional conforming amendments.
Sec. 9008. Controlled substance analogues.
Sec. 9009. Rules of construction.
Sec. 9010. Study by Comptroller General.
Sec. 9011. Report on controlled substance analogues sold by means of
the Internet.
Sec. 9012. Controlled substance analogues.
TITLE X--THRIVE ACT
Sec. 10001. Short title.
Sec. 10002. Demonstration program to study the impact of using rental
vouchers for supportive housing for
individuals recovering from opioid use
disorders or other substance use disorders.
Sec. 10003. Repeal of Rental Voucher Demonstration Program.
Sec. 10004. Demonstration Close-Out.
Sec. 10005. No additional funds authorized.
TITLE XI--IMD CARE ACT
Sec. 11001. Short title.
Sec. 11002. Medicaid State plan option to provide services for certain
individuals with targeted SUDs in
institutions for mental diseases.
Sec. 11003. Promoting value in Medicaid managed care.
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
(29) 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 (29) of section 1905(a) of the Social Security
Act (42 U.S.C. 1396d(a)), 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 section, the Secretary
shall, in consultation, as appropriate, with the Director of
the Agency for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and Substance Use,
conduct a 54-month demonstration project for the purpose
described in paragraph (2) under which the Secretary shall--
``(A) for the first 18-month period of such
project, award planning grants described in paragraph
(3); and
``(B) for the remaining 36-month period of such
project, provide to each State selected under paragraph
(4) payments in accordance with paragraph (5).
``(2) Purpose.--The purpose described in this paragraph is
for each State selected under paragraph (4) to increase the
treatment capacity of providers participating under the State
plan (or a waiver of such plan) to provide substance use
disorder treatment or recovery services under such plan (or
waiver) through the following activities:
``(A) For the purpose described in paragraph
(3)(C)(i), activities that support an ongoing
assessment of the behavioral health treatment needs of
the State, taking into account the matters described in
subclauses (I) through (IV) of such paragraph.
``(B) Activities that, taking into account the
results of the assessment described in subparagraph
(A), support the recruitment, training, and provision
of technical assistance for providers participating
under the State plan (or a waiver of such plan) that
offer substance use disorder treatment or recovery
services.
``(C) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that--
``(i) are authorized to dispense drugs
approved by the Food and Drug Administration
for individuals with a substance use disorder
who need withdrawal management or maintenance
treatment for such disorder;
``(ii) have in effect a registration or
waiver under section 303(g) of the Controlled
Substances Act for purposes of dispensing
narcotic drugs to individuals for maintenance
treatment or detoxification treatment and are
in compliance with any regulation promulgated
by the Assistant Secretary for Mental Health
and Substance Use for purposes of carrying out
the requirements of such section 303(g); and
``(iii) are qualified under applicable
State law to provide substance use disorder
treatment or recovery services.
``(D) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that have the qualifications to address the
treatment or recovery needs of--
``(i) individuals enrolled under the State
plan (or a waiver of such plan) who have
neonatal abstinence syndrome, in accordance
with guidelines issued by the American Academy
of Pediatrics and American College of
Obstetricians and Gynecologists relating to
maternal care and infant care with respect to
neonatal abstinence syndrome;
``(ii) pregnant women, postpartum women,
and infants, particularly the concurrent
treatment, as appropriate, and comprehensive
case management of pregnant women, postpartum
women and infants, enrolled under the State
plan (or a waiver of such plan);
``(iii) adolescents and young adults
between the ages of 12 and 21 enrolled under
the State plan (or a waiver of such plan); or
``(iv) American Indian and Alaska Native
individuals enrolled under the State plan (or a
waiver of such plan).
``(3) Planning grants.--
``(A) In general.--The Secretary shall, with
respect to the first 18-month period of the
demonstration project conducted under paragraph (1),
award planning grants to at least 10 States selected in
accordance with subparagraph (B) for purposes of
preparing an application described in paragraph (4)(C)
and carrying out the activities described in
subparagraph (C).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that have a State plan
(or waiver of the State plan) approved under
this title;
``(ii) select States in a manner that
ensures geographic diversity; and
``(iii) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national
average prevalence, as measured by aggregate
per capita drug overdoses, or any other measure
that the Secretary deems appropriate.
``(C) Activities described.--Activities described
in this subparagraph are, with respect to a State, each
of the following:
``(i) Activities that support the
development of an initial assessment of the
behavioral health treatment needs of the State
to determine the extent to which providers are
needed (including the types of such providers
and geographic area of need) to improve the
network of providers that treat substance use
disorders under the State plan (or waiver),
including the following:
``(I) An estimate of the number of
individuals enrolled under the State
plan (or a waiver of such plan) who
have a substance use disorder.
``(II) Information on the capacity
of providers to provide substance use
disorder treatment or recovery services
to individuals enrolled under the State
plan (or waiver), including information
on providers who provide such services
and their participation under the State
plan (or waiver).
``(III) Information on the gap in
substance use disorder treatment or
recovery services under the State plan
(or waiver) based on the information
described in subclauses (I) and (II).
``(IV) Projections regarding the
extent to which the State participating
under the demonstration project would
increase the number of providers
offering substance use disorder
treatment or recovery services under
the State plan (or waiver) during the
period of the demonstration project.
``(ii) Activities that, taking into account
the results of the assessment described in
clause (i), support the development of State
infrastructure to, with respect to the
provision of substance use disorder treatment
or recovery services under the State plan (or a
waiver of such plan), recruit prospective
providers and provide training and technical
assistance to such providers.
``(D) Funding.--For purposes of subparagraph (A),
there is appropriated, out of any funds in the Treasury
not otherwise appropriated, $50,000,000, to remain
available until expended.
``(4) Post-planning states.--
``(A) In general.--The Secretary shall, with
respect to the remaining 36-month period of the
demonstration project conducted under paragraph (1),
select not more than 5 States in accordance with
subparagraph (B) for purposes of carrying out the
activities described in paragraph (2) and receiving
payments in accordance with paragraph (5).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that received a
planning grant under paragraph (3);
``(ii) select States that submit to the
Secretary an application in accordance with the
requirements in subparagraph (C), taking into
consideration the quality of each such
application;
``(iii) select States in a manner that
ensures geographic diversity; and
``(iv) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national
average prevalence, as measured by aggregate
per capita drug overdoses, or any other measure
that the Secretary deems appropriate.
``(C) Applications.--
``(i) In general.--A State seeking to be
selected for purposes of this paragraph shall
submit to the Secretary, at such time and in
such form and manner as the Secretary requires,
an application that includes such information,
provisions, and assurances, as the Secretary
may require, in addition to the following:
``(I) A proposed process for
carrying out the ongoing assessment
described in paragraph (2)(A), taking
into account the results of the initial
assessment described in paragraph
(3)(C)(i).
``(II) A review of reimbursement
methodologies and other policies
related to substance use disorder
treatment or recovery services under
the State plan (or waiver) that may
create barriers to increasing the
number of providers delivering such
services.
``(III) The development of a plan,
taking into account activities carried
out under paragraph (3)(C)(ii), that
will result in long-term and
sustainable provider networks under the
State plan (or waiver) that will offer
a continuum of care for substance use
disorders. Such plan shall include the
following:
``(aa) Specific activities
to increase the number of
providers (including providers
that specialize in providing
substance use disorder
treatment or recovery services,
hospitals, health care systems,
Federally qualified health
centers, and, as applicable,
certified community behavioral
health clinics) that offer
substance use disorder
treatment, recovery, or support
services, including short-term
detoxification services,
outpatient substance use
disorder services, and
evidence-based peer recovery
services.
``(bb) Strategies that will
incentivize providers described
in subparagraphs (C) and (D) of
paragraph (2) to obtain the
necessary training, education,
and support to deliver
substance use disorder
treatment or recovery services
in the State.
``(cc) Milestones and
timeliness for implementing
activities set forth in the
plan.
``(dd) Specific measurable
targets for increasing the
substance use disorder
treatment and recovery provider
network under the State plan
(or a waiver of such plan).
``(IV) A proposed process for
reporting the information required
under paragraph (6)(A), including
information to assess the effectiveness
of the efforts of the State to expand
the capacity of providers to deliver
substance use disorder treatment or
recovery services during the period of
the demonstration project under this
subsection.
``(V) The expected financial impact
of the demonstration project under this
subsection on the State.
``(VI) A description of all funding
sources available to the State to
provide substance use disorder
treatment or recovery services in the
State.
``(VII) A preliminary plan for how
the State will sustain any increase in
the capacity of providers to deliver
substance use disorder treatment or
recovery services resulting from the
demonstration project under this
subsection after the termination of
such demonstration project.
``(VIII) A description of how the
State will coordinate the goals of the
demonstration project with any waiver
granted (or submitted by the State and
pending) pursuant to section 1115 for
the delivery of substance use services
under the State plan, as applicable.
``(ii) Consultation.--In completing an
application under clause (i), a State shall
consult with relevant stakeholders, including
Medicaid managed care plans, health care
providers, and Medicaid beneficiary advocates,
and include in such application a description
of such consultation.
``(5) Payment.--
``(A) In general.--For each quarter occurring
during the period for which the demonstration project
is conducted (after the first 18 months of such
period), the Secretary shall pay under this subsection,
subject to subparagraph (C), to each State selected
under paragraph (4) an amount equal to 80 percent of so
much of the qualified sums expended during such
quarter.
``(B) Qualified sums defined.--For purposes of
subparagraph (A), the term `qualified sums' means, with
respect to a State and a quarter, the amount equal to
the amount (if any) by which the sums expended by the
State during such quarter attributable to substance use
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
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 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 treatment or recovery
services for which payment is made to the State under
this subsection, on the following:
``(i) The specific activities with respect
to which payment under this subsection was
provided.
``(ii) The number of providers that
delivered substance use disorder treatment or
recovery services in the State under the
demonstration project compared to the estimated
number of providers that would have otherwise
delivered such services in the absence of such
demonstration project.
``(iii) The number of individuals enrolled
under the State plan (or a waiver of such plan)
who received substance use disorder treatment
or recovery services under the demonstration
project compared to the estimated number of
such individuals who would have otherwise
received such services in the absence of such
demonstration project.
``(iv) Other matters as determined by the
Secretary.
``(B) CMS reports.--
``(i) Initial report.--Not later than
October 1, 2020, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress an initial
report on--
``(I) the States awarded planning
grants under paragraph (3);
``(II) the criteria used in such
selection; and
``(III) the activities carried out
by such States under such planning
grants.
``(ii) Interim report.--Not later than
October 1, 2022, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress an interim
report--
``(I) on activities carried out
under the demonstration project under
this subsection;
``(II) on the extent to which
States selected under paragraph (4)
have achieved the stated goals
submitted in their applications under
subparagraph (C) of such paragraph;
``(III) with a description of the
strengths and limitations of such
demonstration project; and
``(IV) with a plan for the
sustainability of such project.
``(iii) Final report.--Not later than
October 1, 2024, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress a final
report--
``(I) providing updates on the
matters reported in the interim report
under clause (ii);
``(II) including a description of
any changes made with respect to the
demonstration project under this
subsection after the submission of such
interim report; and
``(III) evaluating such
demonstration project.
``(C) AHRQ report.--Not later than 3 years after
the date of the enactment of this subsection, the
Director of the Agency for Healthcare Research and
Quality, on 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. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
(a) In General.--Title XIX of the Social Security Act is amended by
inserting after section 1927 (42 U.S.C. 1396r-8) the following new
section:
``SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
``(a) In General.--Beginning January 1, 2020, a State shall operate
a qualified drug management program under which a State may enroll
certain at-risk beneficiaries identified by the State under the
program.
``(b) Qualified Drug Management Program.--For purposes of this
section, the term `qualified drug management program' means, with
respect to a State, a program carried out by the State (including
through a contract with a pharmacy benefit manager) that provides at
least for the following:
``(1) Identification of at-risk individuals.--Under the
program, the State identifies, in accordance with subsection
(c), individuals enrolled under the State plan (or waiver of
the State plan) who are at-risk beneficiaries.
``(2) Elements of program.--
``(A) In general.--Under the program, the State,
with respect to each individual identified under
paragraph (1) and enrolled under the program under
paragraph (5)--
``(i) subject to subparagraphs (B) and (C),
selects at least one, but not more than three,
health care providers and at least one, but not
more than three, pharmacies for each such
individual for purposes of clause (ii), in
accordance with a selection process that takes
into account reasonable factors such as the
individual's previous utilization of items and
services from health care providers and
pharmacies, geographic proximity of the
individual to such health care providers and
pharmacies, access of the individual to health
care, reasonable travel time, information
regarding housing status, and any known
preference of the individual for a certain
health care provider or pharmacy; and
``(ii) requires that any controlled
substance furnished to such individual during
the period for which such individual is
enrolled under the program be prescribed by a
health care provider selected under clause (i)
for such individual and dispensed by a pharmacy
selected under clause (i) for such individual
in order for such controlled substance to be
covered under the State plan (or waiver).
``(B) Beneficiary preference.--In the case of an
individual receiving a notice under paragraph (3)(A) of
being identified as potentially being an at-risk
beneficiary described in such paragraph, such
individual may submit, during the 30-day period
following receipt of such notice, preferences for which
health care providers and pharmacies the individual
would prefer the State to select under subparagraph
(A). The State shall select or change the selection of
health care providers and pharmacies under subparagraph
(A) for the individuals based on such preferences,
except that in the case that State determines that such
selection (or change of selection) of a health care
provider or pharmacy under subparagraph (A) is
contributing or would contribute to prescription drug
abuse or drug diversion by the individual, the State
may select or change the selection of health care
provider or pharmacy for the individual without regard
to the preferences of the individual described in this
subparagraph. If the State selects or changes the
selection pursuant to the preceding sentence without
regard to the preferences of the individual, the State
shall provide the individual with at least 30 days
written notice of the selection or change of selection
and a rationale for the selection or change.
``(C) Treatment of pharmacy with multiple
locations.--For purposes of subparagraph (A)(i), in the
case of a pharmacy that has multiple locations that
share real-time electronic prescription data, all such
locations of the pharmacy shall collectively be treated
as one pharmacy.
``(D) Treatment of existing ffs drug management
programs.--In the case of a patient review and
restriction program (as identified in the annual report
submitted to the Secretary under section 1927(g)(3)(D))
operated by a State pursuant to section 1915(a)(2)
before the date of the enactment of this section, such
program shall be treated as a qualified drug management
program.
``(E) Reasonable access.--The program shall ensure,
including through waiver of elements of the program
(including under subparagraph (A)(ii)), reasonable
access to health care (including access to health care
providers and pharmacies with respect to prescription
drugs described in subparagraph (A)) in the case of
individuals with multiple residences, 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) Notification to identified individuals.--Under the
program, the State provides each individual who is identified
under paragraph (1), prior to enrolling such individual under
the program, at least one notification of each of the
following:
``(A) Notice that the State has identified the
individual as potentially being an at-risk beneficiary
for abuse or misuse of a controlled substance.
``(B) The name, address, and contact information of
each health care provider and pharmacy that may be
selected for the individual under paragraph (2)(A).
``(C) Information describing all State and Federal
public health resources that are designed to address
such abuse or misuse to which the individual has
access, including mental health services, substance use
disorder and recovery services, and other counseling
services.
``(D) Notice of, and information about, the right
of the individual to--
``(i) submit preferences of the individual
for health care providers and pharmacies to be
selected under paragraph (2)(A), including as
described in paragraph (2)(B);
``(ii) appeal under paragraph (4)--
``(I) such identification described
in subparagraph (A); and
``(II) the selection of health care
providers and pharmacies under
paragraph (2)(A).
``(E) An explanation of the meaning and
consequences of the identification of the individual as
potentially being an at-risk beneficiary for abuse or
misuse of a controlled substance, including an
explanation of the program.
``(F) Information, including a contact list and
clear instructions, that explain how the individual can
contact the appropriate entities administering the
program in order to submit preferences described in
paragraph (2)(B) and any other communications relating
to the program.
``(4) Appeals process.--Under the program, the State
provides for an appeals process under which, with respect to an
individual identified under paragraph (1)--
``(A) such individual may appeal--
``(i) such identification; and
``(ii) the selection of a health care
provider or pharmacy under paragraph (2)(A);
``(B) in the case of an appeal described in
subparagraph (A)(ii), the State shall accommodate the
health care provider or pharmacy preferred by the
individual for selection for purposes of paragraph
(2)(A), unless the State determines that a change to
the selection of health care provider or pharmacy under
such paragraph is contributing or would contribute to
prescription drug abuse or drug diversion by the
individual;
``(C) such individual is provided a period of not
less than 30 days following the date of receipt of the
notice described in paragraph (3) to submit such
appeal; and
``(D) the State must make a determination with
respect to an appeal described in subparagraph (A), and
notify the individual of such determination, prior to
enrollment of such individual in the program.
``(5) Enrollment.--Under the program, the State initially
enrolls individuals who are identified under paragraph (1) in
the program for a 12-month period--
``(A) in the case of such an individual who does
not submit an appeal under paragraph (4) within the
period applied by the State pursuant to subparagraph
(C) of such paragraph, beginning on the day after the
last day of such period; and
``(B) in the case of such an individual who does
submit an appeal under paragraph (4) within the period
applied by the State pursuant to subparagraph (C) of
such paragraph but such appeal is denied, beginning not
later than 30 days after the date of such denial.
``(6) Notification of health care providers and
pharmacies.--Under the program, the State provides to each
health care provider and pharmacy selected for an individual
under paragraph (2)--
``(A) notification that the individual is an at-
risk beneficiary enrolled under the program and that
the provider or pharmacy has been selected for the
individual under paragraph (2);
``(B) information on such program and the role of
being so selected; and
``(C) a process through which the provider or
pharmacy can submit a concern or complaint with respect
to being so selected.
``(7) Continuation of enrollment.--Under the program, the
State, with respect to an individual enrolled under the
program, provides for a process to--
``(A) not later than 30 days before the end of the
12-month period for which the individual is so enrolled
pursuant to paragraph (5)--
``(i) assess, in accordance with publicly
available evidence-based guidelines, whether or
not such individual should continue to be
enrolled under the program; and
``(ii) notify such individual of the
results of the assessment under clause (i);
``(B) continue, subject to subparagraph (C),
enrollment of such individual if such assessment
recommends such continuation; and
``(C) appeal the continuation of enrollment in
accordance with the appeals process described in
paragraph (4).
``(c) At-Risk Beneficiary.--
``(1) Identification.--For purposes of this section, a
State shall identify an individual enrolled under the State
plan (or waiver of the State plan) as an at-risk beneficiary if
the individual is not an exempted individual described in
paragraph (2) and--
``(A) is identified as such an at-risk beneficiary
through the use of publicly available evidence-based
guidelines that indicate misuse or abuse of a
controlled substance; or
``(B) the State received notification from a PDP
sponsor or Medicare Advantage organization that such
individual was identified as being an at-risk
beneficiary for prescription drug abuse for enrollment
in a drug management program established by the sponsor
or organization pursuant to section 1860D-4(c)(5) and
such identification has not been terminated under
subparagraph (F) of such section.
``(2) Exempted individual described.--For purposes of
paragraph (1), an exempted individual described in this
paragraph is 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 an exempted
individual for purposes of paragraph (1).
``(d) 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)(6) 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.
``(e) Reports.--
``(1) Annual reports.--A State operating a qualified drug
management program shall include in the annual report submitted
to the Secretary under section 1927(g)(3)(D), beginning with
such reports submitted for 2021, the following information:
``(A) The number of individuals enrolled under the
State plan (or waiver of the State plan) who are
enrolled under the program and the percentage of
individuals enrolled under the State plan (or waiver)
who are enrolled under such program.
``(B) The number of prescriptions for controlled
substances that were dispensed per month during each
such year per individual enrolled under the program,
including the daily morphine milligram equivalents and
the quantity prescribed for each such prescription.
``(C) The number of pharmacies filling
prescriptions for controlled substances for individuals
enrolled under such program.
``(D) The number of health care providers writing
prescriptions for controlled substances (other than
prescriptions for a refill) for individuals enrolled
under such program.
``(E) Any other data that the Secretary may
require.
``(F) Any report submitted by a managed care entity
under subsection (f)(1)(B) with respect to the year
involved.
For each such report for a year after 2021, the information
described in this paragraph shall be provided in a manner that
compares such information with respect to the prior calendar
year to such information with respect to the second prior
calendar year.
``(2) MACPAC reports and review.--Not later than 2 years
after the date of the enactment of this section, the Medicaid
and CHIP Payment and Access Commission (in this section
referred to as `MACPAC'), in consultation with the National
Association of Medicaid Directors, pharmacy benefit managers,
managed care organizations, health care providers (including
pharmacists), beneficiary advocates, and other stakeholders,
shall publish a report that includes--
``(A) best practices for operating drug management
programs, based on a review of a representative sample
of States administering such a program;
``(B) a summary of the experience of the appeals
process under drug management programs operated by
several States, such as the frequency at which
individuals appealed the identification of being an at-
risk individual, the frequency at which individuals
appealed the selection of a health care provider or
pharmacy under such a program, the timeframes for such
appeals, a summary of the reasons for such appeals, and
the design of such appeals processes;
``(C) a summary of trends and the effectiveness of
qualified drug management programs operated under this
section; and
``(D) recommendations to States on how improvements
can be made with respect to the operation of such
programs.
In reporting on State practices, the MACPAC shall consider how
such programs have been implemented in rural areas, under fee-
for-service as well as managed care arrangements, and the
extent to which such programs have resulted in increased
efficiencies to such States or to the Federal Government under
this title.
``(3) Report on plan for coordinated care.--Not later than
January 1, 2021, each State operating a qualified drug
management program shall submit to the Administrator of the
Centers for Medicare & Medicaid Services a report on how such
State plans to provide coordinated care for individuals
enrolled under the State plan (or waiver of the State plan)
and--
``(A) who are enrolled under the program; or
``(B) who are enrolled with a managed care entity
and enrolled under such a qualified drug management
program operated by such entity.
``(f) Applicability to Managed Care Entities.--
``(1) In general.--With respect to any contract that a
State enters into on or after January 1, 2020, with a managed
care entity (as defined in section 1932(a)(1)(B)) pursuant to
section 1903(m), the State shall, as a condition of the
contract, require the managed care entity--
``(A) to operate a qualified drug management
program (as defined in subsection (b)) for at-risk
beneficiaries who are enrolled with such entity and
identified by the managed care entity by means of
application of paragraph (2);
``(B) to submit to the State an annual report on
the matters described in subparagraphs (A) through (E)
of subsection (e)(1); and
``(C) to submit to the State a list (and as
necessary update such list) of individuals enrolled
with such entity under the qualified drug management
program operated by such entity under subparagraph (A)
for purposes of allowing State plans for which medical
assistance is paid on a fee-for-service basis to have
access to such information.
``(2) Application.--For purposes of applying, with respect
to a managed care entity--
``(A) under paragraph (1)(A)--
``(i) the definition of the term `qualified
drug management program' under subsection (b),
other than paragraph (2)(D) of such subsection;
and
``(ii) the provisions of paragraphs (1) and
(2) of subsection (c); and
``(B) under paragraph (1)(B), the report
requirements described in subparagraphs (A) through (E)
of subsection (e)(1);
each reference in such subsection (b) and paragraphs of
subsection (c) to `a State' or `the State' (other than to `a
State plan' or `the State plan') shall be deemed a reference to
the managed care entity, each reference under such subsection,
paragraphs, or subparagraphs to individuals enrolled under the
State plan (or waiver of the State plan) shall be deemed a
reference to individuals enrolled with such entity, and each
reference under such subsection, paragraphs, or subparagraphs
to individuals enrolled under the qualified drug management
program operated by the State shall be deemed a reference to
individuals enrolled under the qualified drug management
program operated by the managed care entity.
``(g) Controlled Substance Defined.--For purposes of this section,
the term `controlled substance' means a drug that is included in
schedule II, III, or IV of section 202(c) of the Controlled Substances
Act, or any combination thereof, as specified by the State.''.
(b) Guidance on At-Risk Population Transitioning Between Medicaid
FFS and Managed Care.--Not later than October 1, 2019, the Secretary of
Health and Human Services shall issue guidance for State Medicaid
programs, with respect to individuals who are enrolled under a State
plan (or waiver of such plan) under title XIX of the Social Security
Act and under a drug management program, for purposes of providing best
practices--
(1) for transitioning, as applicable, such individuals from
fee-for-service Medicaid (and such a program operated by the
State) to receiving medical assistance under such title through
a managed care entity (as defined in section 1932(a)(1)(B) of
the Social Security Act) with a contract that with the State
pursuant to section 1903(m) of such Act (and such a program
operated by such entity); and
(2) for transitioning, as applicable, such individuals from
receiving medical assistance under such title through a managed
care entity (as defined in section 1932(a)(1)(B) of the Social
Security Act) with a contract that with the State pursuant to
section 1903(m) of such Act (and such a program operated by
such entity) to fee-for-service Medicaid (and such a program
operated by the State).
(c) Guidance on At-Risk Population Transitioning to Medicare.--
(1) In general.--Not later than January 1, 2020, the
Secretary of Health and Human Services, after consultation with
the Federal Coordinated Health Care Office established under
section 2602 of the Patient Protection and Affordable Care Act
(42 U.S.C. 1315b), shall issue guidance for State Medicaid
programs, with respect to transitioning individuals, providing
for--
(A) notification to be submitted by the State to
the Centers for Medicare & Medicaid Services and such
individuals of the status of such individuals as
transitioning individuals;
(B) notification to such individuals about
enrollment under a prescription drug plan under part D
of such title or under a MA-PD plan under part C of
such title;
(C) best practices for transitioning such
individuals to such a plan; and
(D) best practices for coordination between the
qualified drug management program (as described in
section 1927A(b) of the Social Security Act, as added
by subsection (a)) carried out by the State and a drug
management program carried out under such a plan
pursuant to section 1860D-4(c)(5) of the Social
Security Act (42 U.S.C. 1395w-10(c)(5)).
(2) Transitioning individuals.--For purposes of paragraph
(1), a transitioning individual is an individual who, with
respect to a month--
(A) is enrolled under the State plan (or waiver of
the State plan) and under the qualified drug management
program (as described in section 1927A(b) of the Social
Security Act, as added by subsection (a)) carried out
by the State; and
(B) is expected to become eligible for the Medicare
program under title XVIII of such Act during the
subsequent 12-month period.
SEC. 1005. 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 101,
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 101, is further amended by adding at the end the
following new subsection:
``(oo) Drug Review and Utilization Requirements.--
``(1) In general.--For purposes of subsection (a)(85), the
drug review and utilization requirements under this subsection
are, subject to paragraph (3) and beginning October 1, 2019,
the following:
``(A) Claims review limitations.--
``(i) In general.--The State has in place--
``(I) safety edits (as specified by
the State) for subsequent fills for
opioids and a claims review automated
process (as designed and implemented by
the State) that indicates when an
individual enrolled under the State
plan (or under a waiver of the State
plan) is prescribed a subsequent fill
of opioids in excess of any limitation
that may be identified by the State;
``(II) safety edits (as specified
by the State) on the maximum daily
morphine equivalent that can be
prescribed to an individual enrolled
under the State plan (or under a waiver
of the State plan) for treatment of
chronic pain and a claims review
automated process (as designed and
implemented by the State) that
indicates when an individual enrolled
under the plan (or waiver) is
prescribed the morphine equivalent for
such treatment in excess of any
limitation that may be identified by
the State; and
``(III) a claims review automated
process (as designed and implemented by
the State) that monitors when an
individual enrolled under the State
plan (or under a waiver of the State
plan) is concurrently prescribed
opioids and--
``(aa) benzodiazepines; or
``(bb) antipsychotics.
``(ii) Managed care entities.--The State
requires each managed care entity (as defined
in section 1932(a)(1)(B)) with respect to which
the State has a contract under section 1903(m)
or under section 1905(t)(3) to have in place,
subject to paragraph (3), with respect to
individuals who are eligible for medical
assistance under the State plan (or under a
waiver of the State plan) and who are enrolled
with the entity, the limitations described in
subclauses (I) and (II) of clause (i) and a
claims review automated process described in
subclause (III) of such clause.
``(iii) Rules of construction.--Nothing in
this subparagraph may be construed as
prohibiting a State or managed care entity from
designing and implementing a claims review
automated process under this subparagraph that
provides for prospective or retrospective
reviews of claims. Nothing in this subparagraph
shall be understood as prohibiting the exercise
of clinical judgment from a provider enrolled
as a participating provider in a State plan (or
waiver of the State plan) or contracting with a
managed care entity regarding the best items
and services for an individual enrolled under
such State plan (or waiver).
``(B) Program to monitor antipsychotic medications
by children.--The State has in place a program (as
designed and implemented by the State) to monitor and
manage the appropriate use of antipsychotic medications
by children enrolled under the State plan (or under a
waiver of the State plan) and submits annually to the
Secretary such information as the Secretary may require
on activities carried out under such program for
individuals not more than the age of 18 years generally
and children in foster care specifically.
``(C) Fraud and abuse identification.--The State
has in place a process (as designed and implemented by
the State) that identifies potential fraud or abuse of
controlled substances by individuals enrolled under the
State plan (or under a waiver of the State plan),
health care providers prescribing drugs to individuals
so enrolled, and pharmacies dispensing drugs to
individuals so enrolled.
``(D) Reports.--The State shall include in the
annual report submitted to the Secretary under section
1927(g)(3)(D) information on the limitations,
requirement, program, and processes applied by the
State under subparagraphs (A) through (C) in accordance
with such manner and time as specified by the
Secretary.
``(E) Clarification.--Nothing shall prevent a State
from satisfying the requirement--
``(i) described in subparagraph (A) by
having safety edits or a claims review
automated process described in such
subparagraph that was in place before October
1, 2019;
``(ii) described in subparagraph (B) by
having a program described in such subparagraph
that was in place before such date; or
``(iii) described in subparagraph (C) by
having a process described in such subparagraph
that was in place before such date.
``(2) Annual report by secretary.--For each fiscal year
beginning with fiscal year 2020, the Secretary shall submit to
Congress a report on the most recent information submitted by
States under paragraph (1)(D).
``(3) Exceptions.--
``(A) Certain individuals exempted.--The drug
review and utilization requirements under this
subsection shall not apply with respect to an
individual who--
``(i) is receiving--
``(I) hospice or palliative care;
or
``(II) treatment for cancer;
``(ii) is a resident of a long-term care
facility, of a facility described in section
1905(d), or of another facility for which
frequently abused drugs are dispensed for
residents through a contract with a single
pharmacy; or
``(iii) the State elects to treat as
exempted from such requirements.
``(B) Exception relating to ensuring access.--In
order to ensure reasonable access to health care, the
Secretary shall waive the drug review and utilization
requirements under this subsection, with respect to a
State, in the case of natural disasters and similar
situations, and in the case of the provision of
emergency services (as defined for purposes of section
1860D-4(c)(5)(D)(ii)(II)).''.
(3) Managed care entities.--Section 1932 of the Social
Security Act (42 U.S.C. 1396u-2) is amended by adding at the
end the following new subsection:
``(i) Drug Utilization Review Activities and Requirements.--
Beginning not later than October 1, 2019, each contract under a State
plan with a managed care entity (other than a primary care case
manager) under section 1903(m) shall provide that the entity is in
compliance with the applicable provisions of section 438.3(s)(2) of
title 42 of the 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. 1006. 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) the types of services, including post-discharge
services and parenting supports, for families of babies with
neonatal abstinence syndrome that States may cover under the
Medicaid program under title XIX of the Social Security Act;
(2) best practices from States with respect to innovative
or evidenced-based payment models that focus on prevention,
screening, treatment, plans of safe care, and post-discharge
services for mothers and fathers with substance use disorders
and babies with neonatal abstinence syndrome that improve care
and clinical outcomes;
(3) 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; and
(4) guidance and technical assistance to State Medicaid
agencies regarding additional flexibilities and incentives
related to screening, prevention, and post-discharge services,
including parenting supports.
(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. 1007. MEDICAID HEALTH HOMES FOR OPIOID-USE-DISORDER MEDICAID
ENROLLEES.
(a) Extension of Enhanced FMAP for Certain Health Homes for
Individuals With Substance Use Disorders.--Section 1945 of the Social
Security Act (42 U.S.C. 1396w-4) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by inserting ``subject to
paragraph (4),'' after ``except that,''; and
(B) by adding at the end the following new
paragraph:
``(4) Special rule relating to substance use disorder
health homes.--
``(A) In general.--In the case of a State with an
SUD-focused State plan amendment approved by the
Secretary on or after October 1, 2018, the Secretary
may, at the request of the State, extend the
application of the Federal medical assistance
percentage described in paragraph (1) to payments for
the provision of health home services to SUD-eligible
individuals under such State plan amendment, in
addition to the first 8 fiscal year quarters the State
plan amendment is in effect, for the subsequent 2
fiscal year quarters that the State plan amendment is
in effect. Nothing in this section shall be construed
as prohibiting a State with a State plan amendment that
is approved under this section and that is not an SUD-
focused State plan amendment from additionally having
approved on or after such date an SUD-focused State
plan amendment under this section, including for
purposes of application of this paragraph.
``(B) Report requirements.--In the case of a State
with an SUD-focused State plan amendment for which the
application of the Federal medical assistance
percentage has been extended under subparagraph (A),
such State shall, at the end of the period of such
State plan amendment, submit to the Secretary a report
on the following, with respect to SUD-eligible
individuals provided health home services under such
State plan amendment:
``(i) The quality of health care provided
to such individuals, with a focus on outcomes
relevant to the recovery of each such
individual.
``(ii) The access of such individuals to
health care.
``(iii) The total expenditures of such
individuals for health care.
For purposes of this subparagraph, the Secretary shall
specify all applicable measures for determining
quality, access, and expenditures.
``(C) Best practices.--Not later than October 1,
2020, the Secretary shall make publicly available on
the Internet website of the Centers for Medicare &
Medicaid Services best practices for designing and
implementing an SUD-focused State plan amendment, based
on the experiences of States that have State plan
amendments approved under this section that include
SUD-eligible individuals.
``(D) Definitions.--For purposes of this paragraph:
``(i) SUD-eligible individuals.--The term
`SUD-eligible individual' means, with respect
to a State, an individual who satisfies all of
the following:
``(I) The individual is an eligible
individual with chronic conditions.
``(II) The individual is an
individual with a substance use
disorder.
``(III) The individual has not
previously received health home
services under any other State plan
amendment approved for the State under
this section by the Secretary.
``(ii) SUD-focused state plan amendment.--
The term `SUD-focused State plan amendment'
means a State plan amendment under this section
that is designed to provide health home
services primarily to SUD-eligible
individuals.''.
(b) Requirement for State Medicaid Plans to Provide Coverage for
Medication-assisted Treatment.--
(1) Requirement for state medicaid plans to provide
coverage for medication-assisted treatment.--Section
1902(a)(10)(A) of the Social Security Act (42 U.S.C.
1396a(a)(10)(A)) is amended, in the matter preceding clause
(i), by striking ``and (28)'' and inserting ``(28), and (29)''.
(2) Inclusion of medication-assisted treatment as medical
assistance.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) is amended--
(A) in paragraph (28), by striking ``and'' at the
end;
(B) by redesignating paragraph (29) as paragraph
(30); and
(C) by inserting after paragraph (28) the following
new paragraph:
``(29) subject to paragraph (2) of subsection (ee), for the
period beginning October 1, 2020, and ending September 30,
2025, medication-assisted treatment (as defined in paragraph
(1) of such subsection); and''.
(3) Medication-assisted treatment defined; waivers.--
Section 1905 of the Social Security Act (42 U.S.C. 1396d) is
amended by adding at the end the following new subsection:
``(ee) Medication-assisted Treatment.--
``(1) Definition.--For purposes of subsection (a)(29), the
term `medication-assisted treatment'--
``(A) means all drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), including methadone, and all biological products
licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262) to treat opioid use disorders; and
``(B) includes, with respect to the provision of
such drugs and biological products, counseling services
and behavioral therapy.
``(2) Exception.--The provisions of paragraph (29) of
subsection (a) shall not apply with respect to a State for the
period specified in such paragraph, if before the beginning of
such period the State certifies to the satisfaction of the
Secretary that implementing such provisions statewide for all
individuals eligible to enroll in the State plan (or waiver of
the State plan) would not be feasible by reason of a shortage
of qualified providers of medication-assisted treatment, or
facilities providing such treatment, that will contract with
the State or a managed care entity with which the State has a
contract under section 1903(m) or under section 1905(t)(3).''.
(4) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with
respect to medical assistance provided on or after
October 1, 2020, and before October 1, 2025.
(B) Exception for state legislation.--In the case
of a State plan under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) that the Secretary of
Health and Human Services determines requires State
legislation in order for the respective plan to meet
any requirement imposed by the amendments made by this
subsection, the respective plan shall not be regarded
as failing to comply with the requirements of such
title solely on the basis of its failure to meet such
an additional requirement before the first day of the
first calendar quarter beginning after the close of the
first regular session of the State legislature that
begins after the date of the enactment of this Act. For
purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year
of the session shall be considered to be a separate
regular session of the State legislature.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 2001. AUTHORITY NOT TO APPLY CERTAIN MEDICARE TELEHEALTH
REQUIREMENTS IN THE CASE OF CERTAIN TREATMENT OF A
SUBSTANCE USE DISORDER OR CO-OCCURRING MENTAL HEALTH
DISORDER.
Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is
amended--
(1) in paragraph (2)(B)(i), by inserting ``and paragraph
(7)(E)'' after ``Subject to clause (ii)''; and
(2) by adding at the end the following new paragraphs:
``(7) Authority not to apply certain requirements in the
case of certain treatment of substance use disorder or co-
occurring mental health disorder.--
``(A) In general.--For purposes of payment under
this subsection, in the case of telehealth services
described in subparagraph (C) furnished on or after
January 1, 2020, to an eligible beneficiary (as defined
in subparagraph (F)) for the treatment of a substance
use disorder or a mental health disorder that is co-
occurring with a substance use disorder, the Secretary
is authorized to, through rulemaking, not apply any of
the requirements described in subparagraph (B).
``(B) Requirements described.--For purposes of this
paragraph, the requirements described in this
subparagraph are any of the following:
``(i) Qualifications for an originating
site under paragraph (4)(C)(ii).
``(ii) Geographic limitations under
paragraph (4)(C)(i).
``(C) Telehealth services described.--For purposes
of this paragraph, the telehealth services described in
this subparagraph are services that are both telehealth
services (as described in paragraph (4)(F)) and
identified by the Secretary, through rulemaking, as
services that are the most commonly furnished (as
defined by the Secretary) under this part to
individuals diagnosed with a substance use disorder or
a mental health disorder that is co-occurring with a
substance use disorder.
``(D) Clarification.--Nothing in this paragraph
shall be construed as limiting or otherwise affecting
the authority of the Secretary to limit or eliminate
the non-application pursuant to this paragraph of any
of the requirements under subparagraph (B).
``(E) Treatment of originating site facility fee.--
No facility fee shall be paid under paragraph (2)(B) to
an originating site with respect to a telehealth
service described in subparagraph (B) for which payment
is made under this subsection by reason of the non-
application of a requirement described in subparagraph
(B) pursuant to this paragraph if payment for such
service would not otherwise be permitted under this
subsection if such requirement were applied.
``(F) Eligible beneficiary defined.--For purposes
of this paragraph, the term `eligible beneficiary'
means an individual who--
``(i) is entitled to, or enrolled for,
benefits under part A and enrolled for benefits
under this part;
``(ii) has a diagnosis for a substance use
disorder; and
``(iii) meets such other criteria as the
Secretary determines appropriate.
``(G) Report.--Not later than 5 years after the
date of the enactment of this paragraph, the Secretary
shall submit to Congress a report on the impact of any
non-application under this paragraph of any of the
requirements described in subparagraph (B) on
``(i) the utilization of health care
services related to substance use disorder,
such as behavioral health services and
emergency department visits; and
``(ii) health outcomes related to substance
use disorder, such as substance use overdose
deaths.
``(H) Funding.--For purposes of carrying out this
paragraph, 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.
``(8) Rule of construction.--Nothing in this subsection may
be construed as waiving requirements under this title to comply
with applicable State law, including State licensure
requirements.''.
SEC. 2002. ENCOURAGING THE USE OF NON-OPIOID ANALGESICS FOR THE
MANAGEMENT OF POST-SURGICAL PAIN.
Section 1833(t)(6) of the Social Security Act (42 U.S.C.
1395l(t)(6)) is amended--
(1) in subparagraph (C)(i), by inserting ``or, in the case
of an eligible non-opioid analgesic (as defined in subparagraph
(J)), during a period of 5 years,'' after ``3 years,''; and
(2) by adding at the end the following new subparagraph:
``(J) Eligible non-opioid analgesic defined.--In
this paragraph, the term `eligible non-opioid
analgesic' means a drug or biological--
``(i) that is an analgesic that is not an
opioid;
``(ii) that demonstrated substantial
clinical improvement, as determined by the
Secretary; and
``(iii) for which payment--
``(I) as an outpatient hospital
service under this part was not being
made as of the date of the enactment of
this subparagraph; or
``(II) was being made under this
paragraph as of such date.''.
SEC. 2003. REQUIRING A REVIEW OF CURRENT OPIOID PRESCRIPTIONS FOR
CHRONIC PAIN AND SCREENING FOR OPIOID USE DISORDER TO BE
INCLUDED IN THE WELCOME TO MEDICARE INITIAL PREVENTIVE
PHYSICAL EXAMINATION.
(a) In General.--Section 1861(ww) of the Social Security Act (42
U.S.C. 1395x(ww)) is amended--
(1) in paragraph (1), by inserting ``and a review of
current opioid prescriptions and screening for opioid use
disorder (as defined in paragraph (4)),'' before ``but does not
include''; and
(2) by adding at the end the following new paragraph:
``(4)(A) For purposes of paragraph (1), the term `a review of
current opioid prescriptions and screening for opioid use disorder'
means, with respect to an individual--
``(i) a review by a physician or qualified non-physician
practitioner of all current prescriptions of the individual;
and
``(ii) in the case of an individual determined by the
review of a physician or qualified non-physician practitioner
under subparagraph (A) to have a current prescription for
opioids for chronic pain that has been prescribed for a minimum
period of time (as specified by the Secretary)--
``(I) a review by the physician or practitioner of
the potential risk factors to the individual for opioid
use disorder;
``(II) an evaluation by the physician or
practitioner of pain of the individual;
``(III) the provision of information regarding non-
opioid treatment options for the treatment and
management of any chronic pain of the individual; and
``(IV) if determined necessary by the physician or
practitioner based on the results of the review and
evaluation conducted as described in this paragraph, an
appropriate referral by the physician or practitioner
for additional treatment.
``(B) For purposes of this paragraph, the term `qualified non-
physician practitioner' means a physician assistant, nurse
practitioner, or clinical nurse specialist.''.
(b) Clarification.--Nothing in the amendments made by subsection
(a) 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.
(c) Effective Date.--The amendments made by subsection (a) shall
apply with respect to initial preventive physical examinations
furnished on or after January 1, 2020.
SEC. 2004. MODIFICATION OF PAYMENT FOR CERTAIN OUTPATIENT SURGICAL
SERVICES.
(a) Freeze of Payment for Certain Services Furnished in Ambulatory
Surgical Centers.--Section 1833(i)(2) of the Social Security Act (42
U.S.C. 1395l(i)(2)) is amended by adding at the end the following new
subparagraph:
``(F)(i) With respect to a targeted procedure (as defined
in clause (ii)) furnished during 2020 or a subsequent year
(before 2024) to an individual in an ambulatory surgical
center, the payment amount for such procedure that would
otherwise be determined under the revised payment system under
subparagraph (D), without application of this subparagraph,
shall be equal to the payment amount for such procedure
furnished in 2016.
``(ii) For purposes of clause (i), the term `targeted
procedure' means a procedure to which Healthcare Common
Procedure Coding System code 62310 (or, for years beginning
after 2016, 62321), 62311 (or, for years beginning after 2016,
62323), 62264, 64490, 64493, or G0260, or any successor code,
apply.
``(iii) This subparagraph shall not be applied in a budget-
neutral manner.''.
(b) Data Collection.--
(1) In general.--The Comptroller General shall collect data
relating to the cost differential between targeted procedures
(as defined in section 1833(i)(2)(F)(ii) of the Social Security
Act, as added by subsection (a)) that are performed in a
hospital operating room and such procedures that are performed
in an office setting within a hospital in order to determine
whether such procedures are being properly coded for claims,
based on setting, for payment under section 1833(i)(2)(D) of
the Social Security Act (42 U.S.C. 1395l(i)(2)(D)) and to
determine if further changes are needed in the classification
system for covered outpatient department services (as described
in section 1833(t)(2)(A) of the Social Security Act (42 U.S.C.
1395l(t)(2)(A)).
(2) Report.--Not later than 4 years after the date of the
enactment of this Act, the Comptroller General shall submit a
report to the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of Representatives and
the Committee on Finance of the Senate containing--
(A) a determination of whether procedures described
in paragraph (1) are being properly coded for claims,
based on setting, for payment under section
1833(i)(2)(D) of the Social Security Act (42 U.S.C.
1395l(i)(2)(D)); and
(B) recommendations on any changes the Comptroller
General determines are needed in the classification
system for covered outpatient department services (as
described in section 1833(t)(2)(A) of the Social
Security Act (42 U.S.C. 1395l(t)(2)(A)).
(c) Study.--Not later than 3 years 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 the extent to which procedures
described in section 1833(i)(2)(F)(ii) of the Social Security Act, as
added by subsection (a), are effective at preventing the need for
opioids for individuals furnished such procedures.
SEC. 2005. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D
CONTROLLED SUBSTANCES.
(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, pursuant to rulemaking, specify
circumstances with respect to 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 dispenser 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 has received a waiver or a
renewal thereof for a specified period
determined by the Secretary, not to exceed 1
year, from the requirement to use electronic
prescribing, pursuant to a process established
by regulation by the Secretary, 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 allowing for the dispensing of a
non-patient specific prescription pursuant to a
standing order, approved protocol for drug
therapy, collaborative drug management, or
comprehensive medication management, in
response to a public health emergency, or other
circumstances where the practitioner may issue
a non-patient specific prescription;
``(vi) a prescription issued by a
practitioner prescribing a drug under a
research protocol;
``(vii) 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; and
``(viii) a prescription issued by a
practitioner for an individual who--
``(I) receives hospice care under
this title; or
``(II) is a resident of a skilled
nursing facility (as defined in section
1819(a)), or a medical institution or
nursing facility for which payment is
made for an institutionalized
individual under section 1902(q)(1)(B),
for which frequently abused drugs are
dispensed for residents through a
contract with a single pharmacy, as
determined by the Secretary in
accordance with this paragraph.
``(C) Dispensing.--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). 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. Nothing in this paragraph
shall be construed as affecting the ability of the
beneficiary involved to designate a particular pharmacy
to dispense a prescribed drug to the extent consistent
with the requirements under subsection (b)(1) and under
this paragraph.
``(D) Enforcement.--The Secretary shall, pursuant
to rulemaking, have authority to enforce and specify
appropriate penalties for non-compliance with the
requirement under subparagraph (A).''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to coverage of drugs prescribed on or after January 1, 2021.
SEC. 2006. 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, 2021, 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, 2021, a PDP sponsor shall)''
after ``A PDP sponsor may''.
SEC. 2007. 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 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 opioid treatment program (as
defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the
Substance Abuse and Mental Health Services
Administration for such a program;
``(C) is accredited by an accrediting body approved
by the Substance Abuse and Mental Health Services
Administration; and
``(D) meets such additional conditions as the
Secretary may find necessary to ensure--
``(i) the health and safety of individuals
being furnished services under such program;
and
``(ii) the effective and efficient
furnishing of such services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (BB)'' and inserting
``(BB)''; and
(B) by inserting before the semicolon at the end
the following ``, and (CC) with respect to opioid use
disorder treatment services furnished during an episode
of care, the amount paid shall be equal to the amount
payable under section 1834(w) less any copayment
required as specified by the Secretary''.
(2) Payment determination.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the end
the following new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a bundled
payment under this part for opioid use disorder treatment
services (as defined in paragraph (1) of such section) that are
furnished by such program to an individual during an episode of
care (as defined by the Secretary) beginning on or after
January 1, 2020. The Secretary shall ensure, as determined
appropriate by the Secretary, that no duplicative payments are
made under this part or part D for items and services furnished
by an opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services, the scope of services furnished, characteristics of
the individuals furnished such services, or other factors as
the Secretary determine appropriate. In developing such
bundles, the Secretary may consider payment rates paid to
opioid treatment programs for comparable services under State
plans under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
``(3) Annual updates.--The Secretary shall provide an
update each year to the bundled payment amounts under this
subsection.''.
(d) Including Opioid Treatment Programs as Medicare Providers.--
Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is
amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph
(2) of section 1861(jjj)), but only with respect to the
furnishing of opioid use disorder treatment services (as
defined in paragraph (1) of such section).''.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 3001. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN AND
ADDICTION THERAPIES.
(a) Public Meetings.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall hold not less
than one public meeting to address the challenges and barriers of
developing non-addictive medical products intended to treat pain or
addiction, which may include--
(1) the 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;
and
(2) 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 later than 1 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-opioid or 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;
and
(2) the methods by which sponsors may evaluate acute and
chronic pain, endpoints for non-addictive medical products
intended to treat pain, the manner in which endpoints and
evaluations of efficacy will be applied across and within
review divisions, taking into consideration the etiology of the
underlying disease, and the manner in which sponsors may use
surrogate endpoints, intermediate endpoints, and real world
evidence.
(c) Medical Product Defined.--In this section, 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))).
SEC. 3002. SURVEILLANCE AND TESTING OF OPIOIDS TO PREVENT FENTANYL
DEATHS.
(a) Public Health Laboratories to Detect Fentanyl.--Part F of title
III of the Public Health Service Act (42 U.S.C. 262 et seq.) is
amended--
(1) in the heading of part F, by striking ``and Clinical
Laboratories'' and inserting ``, Clinical Laboratories, and
Public Health Laboratories''; and
(2) by adding at the end the following new subpart:
``Subpart 4--Public Health Laboratories
``SEC. 355. PUBLIC HEALTH LABORATORIES TO DETECT FENTANYL.
``(a) In General.--The Secretary shall establish a program to award
grants to Federal, State, and local agencies to support the
establishment or operation of public health laboratories to detect
fentanyl, its analogues, and other synthetic opioids, as described in
subsection (b).
``(b) Standards.--The Secretary, in consultation with the Director
of the National Institute of Standards and Technology, shall--
``(1) develop standards for safely and effectively handling
and testing fentanyl, its analogues, and other synthetic
opioids;
``(2) develop fentanyl and fentanyl analog reference
materials and quality control standards and protocols to
calibrate instrumentation for clinical diagnostics and
postmortem surveillance; and
``(3) include in the standards developed pursuant to
paragraph (1) procedures for encountering new and emerging
synthetic opioid formulations and reporting those findings to
other Federal, State, and local public health laboratories.
``(c) Laboratories.--The Secretary shall require grantees under
subsection (a) to--
``(1) follow the standards established under subsection (b)
and be capable of providing systematic and routine laboratory
testing of drugs for the purposes of obtaining and
disseminating 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 feasible, to develop real-time information on
the purity and movement of fentanyl, its analogues, and other
synthetic opioids;
``(3) assist State and local law enforcement agencies in
testing seized drugs when State and local forensic laboratories
request additional assistance;
``(4) provide early warning information and advice to
Federal, State, and local law enforcement agencies and public
health authorities regarding potential significant changes in
the supply of fentanyl, its analogues, and other synthetic
opioids;
``(5) provide biosurveillance for non-fatal exposures; and
``(6) provide diagnostic testing for non-fatal exposures of
emergency personnel.
``(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.''.
(b) Enhanced Fentanyl Surveillance.--Title III of the Public Health
Service Act is amended by inserting after section 317T of such Act (42
U.S.C. 247b-22) the following new section:
``SEC. 317U. ENHANCED FENTANYL SURVEILLANCE.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention shall enhance its drug surveillance program by--
``(1) expanding its surveillance program to include all 50
States and the territories of the United States;
``(2) increasing and accelerating the collection of data on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including related overdose data from
medical examiners and drug treatment admissions; and
``(3) utilizing available and emerging information on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including information from--
``(A) the National Drug Early Warning System;
``(B) State and local public health authorities;
and
``(C) Federal, State, and local public health
laboratories.
``(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2019 through 2023.''.
(c) Pilot Program for Point-of-Use Testing of Illicit Drugs for
Dangerous Contaminants.--Part P of title III of the Public Health
Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end
the following new section:
``SEC. 399V-7. PILOT PROGRAM FOR POINT-OF-USE TESTING OF ILLICIT DRUGS
FOR DANGEROUS CONTAMINANTS.
``(a) In General.--The Secretary shall--
``(1) establish a pilot program through which 5 State or
local agencies conduct, in 5 States, point-of-use testing of
illicit drugs for dangerous contaminants;
``(2) establish metrics to evaluate the success of the
pilot program in reducing drug overdose rates; and
``(3) based on such metrics, conduct an annual evaluation
of the pilot program and submit an annual report to the
Congress containing the results of such evaluation.
``(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 3003. 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);
or
``(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)).''.
(b) Eliminating Any Time Limitation for Nurse Practitioners and
Physician Assistants To Become Qualifying Practitioners.--Clause (iii)
of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)) is amended--
(1) in subclause (I), by striking ``or'' at the end; and
(2) by amending subclause (II) to read as follows:
``(II) a qualifying other practitioner, as defined
in clause (iv), who is a nurse practitioner or
physician assistant; or''.
(c) Imposing a Time Limitation for Clinical Nurse Specialists,
Certified Registered Nurse Anesthetists, and Certified Nurse Midwifes
To Become Qualifying Practitioners.--Clause (iii) of section
303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)),
as amended by subsection (b), is further amended by adding at the end
the following:
``(III) for the period beginning on October 1,
2018, and ending on October 1, 2023, a qualifying other
practitioner, as defined in clause (iv), who is a
clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife.''.
(d) Definition of Qualifying Other Practitioner.--Section
303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)(iv)) is amended by striking ``nurse practitioner or
physician assistant'' each place it appears and inserting ``nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, certified nurse midwife, or physician assistant''.
(e) Report by Secretary.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human Services,
in consultation with the Drug Enforcement Administration, shall submit
to Congress a report that assesses the care provided by qualifying
practitioners (as defined in section 303(g)(2)(G)(iii) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are
treating, in the case of physicians, more than 100 patients, and in the
case of qualifying practitioners who are not physicians, more than 30
patients. Such report shall include recommendations on future
applicable patient number levels and limits. In preparing such report,
the Secretary shall study, with respect to opioid use disorder
treatment--
(1) the average frequency with which qualifying
practitioners see their patients;
(2) the average frequency with which patients receive
counseling, including the rates by which such counseling is
provided by such a qualifying practitioner directly, or by
referral;
(3) the frequency of toxicology testing, including the
average frequency with which random toxicology testing is
administered;
(4) the average monthly patient caseload for each type of
qualifying practitioner;
(5) the treatment retention rates for patients;
(6) overdose and mortality rates; and
(7) any available information regarding the diversion of
drugs by patients receiving such treatment from such a
qualifying practitioner.
SEC. 3004. HIGH-QUALITY, EVIDENCE-BASED OPIOID ANALGESIC PRESCRIBING
GUIDELINES AND REPORT.
(a) Guidelines.--The Commissioner of Food and Drugs shall develop
high-quality, evidence-based opioid analgesic prescribing guidelines
for the indication-specific treatment of acute pain in 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) conduct a public workshop, open to representatives of
State medical societies and medical boards, various medical
specialties including pain medicine specialty societies,
patient groups, pharmacists, universities, and others; and
(2) provide a period for the submission of comments by the
public.
(c) Report.--Not later than the date that is 2 years after the date
of enactment of this Act, 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 guidelines under subsection
(a) will be utilized to protect the public health.
(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 subsection (c).
(e) Statement To Accompany Guidelines and Recommendations.--The
Commissioner of Food and Drugs shall ensure that any 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) should not be used by other parties, including pharmacy
benefit management companies, retail or community pharmacies,
or public and private payors, 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.
(f) Definition.--In this section, the term ``evidence-based'' means
informed by a robust and systemic review of treatment efficacy and
clinical evidence.
SEC. 3005. REPORT ON OPIOIDS PRESCRIBING PRACTICES FOR PREGNANT WOMEN.
(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
coordination with the Centers for Disease Control and Prevention, the
National Institutes of Health, and the Substance Abuse and Mental
Health Services Administration shall develop and submit to the Congress
a report--
(1) on opioids prescribing practices for pregnant women and
recommendations for such practices;
(2) that provides recommendations for identifying and
reducing opioids misuse during pregnancy;
(3) on prescription opioid misuse during pregnancy in urban
and rural areas;
(4) on prescription opioid use during pregnancy for the
purpose of medication-assisted treatment in urban and rural
areas;
(5) evaluating current utilization of non-opiate pain
management practices in place of prescription opioids during
pregnancy;
(6) providing guidelines encouraging the use of non-opioid
pain management practices during pregnancy when safe and
effective; and
(7) that provides recommendations for increasing public
awareness and education of opioid use disorder in pregnancy,
including available treatment resources in urban and rural
areas.
(b) No Additional Funds.--No additional funds are authorized to be
appropriated for purposes of carrying out subsection (a).
SEC. 3006. GUIDELINES FOR PRESCRIBING NALOXONE.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidelines for prescribing an opioid overdose reversal drug.
(b) Contents.--In issuing guidelines under subsection (a), the
Secretary shall address the following:
(1) Co-prescribing an opioid overdose reversal drug in
conjunction with any prescribed opioid.
(2) Dosage safety.
(3) Prescribing an opioid overdose reversal drug to an
individual other than a patient.
(4) Standing orders.
(5) Other distribution, education, and safety measures as
determined necessary.
SEC. 3007. REQUIRING A SURVEY 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 survey
of all entities that receive Federal funding for the purpose of
providing substance use disorder treatment services. The survey shall
direct such entities to provide the following information:
(1) The length of time the entity has provided substance
use disorder treatment services.
(2) A detailed description of the patient population served
by the entity, including but not limited to the number of
patients, type of addictions, geographic area served, as well
as gender, racial, ethnic and socioeconomic demographics of
such patients.
(3) A detailed description of the types of addiction for
which the entity has the experience, capability, and capacity
to provide such services.
(4) An explanation of how the entity handles patients
requiring treatment for a substance use disorder that the
organization is not able to treat.
(5) A description of what is needed, in the opinion of the
entity, 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
through additional Federal, State, or local government
resources or funding to treat addiction to methamphetamine,
crack cocaine, other types of cocaine, heroin, opioids, and
other commonly abused drugs.
(b) Report.--Not later than 1 year 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).
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)) is
amended by adding at the end the following new paragraph:
``(7)(A) With respect to expenditures described in subparagraph (B)
that are incurred by a State for any fiscal year after fiscal year 2020
(and before fiscal year 2024), in determining the pro rata share to
which the United States is equitably entitled under subsection (d)(3),
the Secretary shall substitute the Federal medical assistance
percentage that applies for such fiscal year to the State under section
1905(b) (without regard to any adjustments to such percentage
applicable under such section or any other provision of law) for the
percentage that applies to such expenditures under section 1905(y).
``(B) Expenditures described in this subparagraph, with respect to
a fiscal year to which subparagraph (A) applies, are expenditures
incurred by a State for payment for medical assistance provided to
individuals described in subclause (VIII) of section 1902(a)(10)(A)(i)
by a managed care entity, or other specified entity (as defined in
subparagraph (D)(iii)), that are treated as remittances because the
State--
``(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
``(I) in the case of a State described in
subparagraph (C), to apply a minimum medical loss ratio
(as defined in subparagraph (D)(ii)) that is at least
85 percent but not greater than the minimum medical
loss ratio (as so defined) that such State applied as
of May 31, 2018; or
``(II) in the case of a State not described in
subparagraph (C), to apply a minimum medical loss ratio
that is equal to 85 percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described in this
subparagraph is a State that as of May 31, 2018, applied a minimum
medical loss ratio (as calculated under subsection (d) of section 438.8
of title 42, Code of Federal Regulations (as in effect on June 1,
2018)) for payment for services provided by entities described in such
subparagraph under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid
managed care organization described in section
1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as calculated
under subsection (d) of section 438.8 of title 42, Code of
Federal Regulations (as in effect on June 1, 2018)) for payment
for services provided by entities described in subparagraph (B)
under the State plan under this title (or a waiver of the
plan).
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined
in section 438.2 of title 42, Code of Federal
Regulations (or any successor regulation); and
``(II) a prepaid ambulatory health plan, as defined
in such section (or any successor regulation).''.
SEC. 4002. EXTENDING PERIOD OF APPLICATION OF MEDICARE SECONDARY PAYER
RULES FOR INDIVIDUALS WITH END STAGE RENAL DISEASE.
Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C.
1395y(b)(1)(C)) is amended--
(1) in the last sentence, by inserting ``and before January
1, 2020'' after ``date of enactment of the Balanced Budget Act
of 1997''; and
(2) by adding at the end the following new sentence:
``Effective for items and services furnished on or after
January 1, 2020 (with respect to periods beginning on or after
July 1, 2018), clauses (i) and (ii) shall be applied by
substituting `33-month' for `12-month' each place it
appears.''.
SEC. 4003. 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''.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
SEC. 5001. MANDATORY REPORTING WITH RESPECT TO ADULT BEHAVIORAL HEALTH
MEASURES.
Section 1139B of the Social Security Act (42 U.S.C. 1320b-9b) is
amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Not later than January 1,
2013'' and inserting the following:
``(A) Voluntary reporting.--Not later than January
1, 2013''; and
(ii) by adding at the end the following:
``(B) Mandatory reporting with respect to
behavioral health measures.--Beginning with the State
report required under subsection (d)(1) for 2024, the
Secretary shall require States to use all behavioral
health measures included in the core set of adult
health quality measures and any updates or changes to
such measures to report information, using the
standardized format for reporting information and
procedures developed under subparagraph (A), regarding
the quality of behavioral health care for Medicaid
eligible adults.''; and
(B) in paragraph (5), by adding at the end the
following new subparagraph:
``(C) Behavioral health measures.--Beginning with
respect to State reports required under subsection
(d)(1) for 2024, the core set of adult health quality
measures maintained under this paragraph (and any
updates or changes to such measures) shall include
behavioral health measures.''; and
(2) in subsection (d)(1)(A)--
(A) by striking ``the such plan'' and inserting
``such plan''; and
(B) by striking ``subsection (a)(5)'' and inserting
``subsection (b)(5) and, beginning with the report for
2024, all behavioral health measures included in the
core set of adult health quality measures maintained
under such subsection (b)(5) and any updates or changes
to such measures (as required under subsection
(b)(3))''.
Subtitle B--Medicaid IMD Additional Info
SEC. 5011. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Institutes for Mental
Disease Are Decisive in Delivering Inpatient Treatment for Individuals
but Opportunities for Needed Access are Limited without Information
Needed about Facility Obligations Act'' or the ``Medicaid IMD
ADDITIONAL INFO Act''.
SEC. 5012. MACPAC EXPLORATORY STUDY AND REPORT ON INSTITUTIONS FOR
MENTAL DISEASES REQUIREMENTS AND PRACTICES UNDER
MEDICAID.
(a) In General.--Not later than January 1, 2020, the Medicaid and
CHIP Payment and Access Commission established under section 1900 of
the Social Security Act (42 U.S.C. 1396) shall conduct an exploratory
study, using data from a representative sample of States, and submit to
Congress a report on at least the following information, with respect
to services furnished to individuals enrolled under State plans under
the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et
seq.) (or waivers of such plans) who are patients in institutions for
mental diseases and for which payment is made through fee-for-service
or managed care arrangements under such State plans (or waivers):
(1) A description of such institutions for mental diseases
in each such State, including at a minimum--
(A) the number of such institutions in the State;
(B) the facility type of such institutions in the
State; and
(C) any coverage limitations under each such State
plan (or waiver) on scope, duration, or frequency of
such services.
(2) With respect to each such institution for mental
diseases in each such State, a description of--
(A) such services provided at such institution;
(B) the process, including any timeframe, used by
such institution to clinically assess and reassess such
individuals; and
(C) the discharge process used by such institution,
including any care continuum of relevant services or
facilities provided or used in such process.
(3) A description of--
(A) any Federal waiver that each such State has for
such institutions and the Federal statutory authority
for such waiver; and
(B) any other Medicaid funding sources used by each
such State for funding such institutions, such as
supplemental payments.
(4) A summary of State requirements (such as certification,
licensure, and accreditation) applied by each such State to
such institutions in order for such institutions to receive
payment under the State plan (or waiver) and how each such
State determines if such requirements have been met.
(5) A summary of State standards (such as quality
standards, clinical standards, and facility standards) that
such institutions must meet to receive payment under such State
plans (or waivers) and how each such State determines if such
standards have been met.
(6) Recommendations for actions by Congress and the Centers
for Medicare & Medicaid Services. such as 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 435.1009 of title 42, Code of Federal
Regulations, or any successor regulation.
Subtitle C--CHIP Mental Health Parity
SEC. 5021. SHORT TITLE.
This subtitle may be cited as the ``CHIP Mental Health 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 women (as defined in section
2112(d)) shall--
``(A) include coverage of mental health services
(including behavioral health treatment) necessary to
prevent, diagnose, and treat a broad range of mental
health symptoms and disorders, including substance use
disorders; and
``(B) be delivered in a culturally and
linguistically appropriate manner.''.
(2) Conforming amendments.--
(A) Section 2103(a) of the Social Security Act (42
U.S.C. 1397cc(a)) is amended, in the matter before
paragraph (1), by striking ``paragraphs (5), (6), and
(7)'' and inserting ``paragraphs (5), (6), (7), and
(8)''.
(B) Section 2110(a) of the Social Security Act (42
U.S.C. 1397jj(a)) is amended--
(i) in paragraph (18), by striking
``substance abuse'' each place it appears and
inserting ``substance use''; and
(ii) in paragraph (19), by striking
``substance abuse'' and inserting ``substance
use''.
(C) Section 2110(b)(5)(A)(i) of the Social Security
Act (42 U.S.C. 1397jj(b)(5)(A)(i)) is amended by
striking ``subsection (c)(5)'' and inserting
``subsection (c)(6)''.
(c) Assuring Access to Care.--Section 2102(a)(7)(B) of the Social
Security Act (42 U.S.C. 1397bb(c)(2)) is amended by striking ``section
2103(c)(5)'' and inserting ``paragraphs (5) and (6) of section
2103(c)''.
(d) Mental Health Services Parity.--Subparagraph (A) of paragraph
(7) of section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c))
(as redesignated by subsection (b)(1)) is amended to read as follows:
``(A) In general.--A State child health plan shall
ensure that the financial requirements and treatment
limitations applicable to mental health and substance
use disorder services (as described in paragraph (5))
provided under such plan comply with the requirements
of section 2726(a) of the Public Health Service Act in
the same manner as such requirements or limitations
apply to a group health plan under such section.''.
(e) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect with respect to child
health assistance provided on or after the date that is 1 year
after the date of the enactment of this Act.
(2) Exception for state legislation.--In the case of a
State child health plan under title XXI of the Social Security
Act (or a waiver of such plan), which the Secretary of Health
and Human Services determines requires State legislation in
order for the respective plan (or waiver) to meet any
requirement imposed by the amendments made by this section, the
respective plan (or waiver) shall not be regarded as failing to
comply with the requirements of such title solely on the basis
of its failure to meet such an additional requirement before
the first day of the first calendar quarter beginning after the
close of the first regular session of the State legislature
that begins after the date of enactment of this section. For
purposes of the previous sentence, in the case of a State that
has a 2-year legislative session, each year of the session
shall be considered to be a separate regular session of the
State legislature.
Subtitle D--Medicaid Reentry
SEC. 5031. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Reentry Act''.
SEC. 5032. PROMOTING STATE INNOVATIONS TO EASE TRANSITIONS INTEGRATION
TO THE COMMUNITY FOR CERTAIN INDIVIDUALS.
(a) Stakeholder Group Development of Best Practices; State Medicaid
Program Innovation.--
(1) Stakeholder group best practices.--Not later than 6
months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall convene a
stakeholder group of representatives of managed care
organizations, Medicaid beneficiaries, health care providers,
the National Association of Medicaid Directors, and other
relevant representatives from local, State, and Federal jail
and prison systems to develop best practices (and submit to the
Secretary and Congress a report on such best practices) for
States--
(A) to ease the health care-related transition of
an individual who is an inmate of a public institution
from the public institution to the community, including
best practices for ensuring continuity of health
insurance coverage or coverage under the State Medicaid
plan under title XIX of the Social Security Act, as
applicable, and relevant social services; and
(B) to carry out, with respect to such an
individual, such health care-related transition not
later than 30 days after such individual is released
from the public institution.
(2) State medicaid program innovation.--The Secretary of
Health and Human Services shall work with States on innovative
strategies to help individuals who are inmates of public
institutions and otherwise eligible for medical assistance
under the Medicaid program under title XIX of the Social
Security Act transition, with respect to enrollment for medical
assistance under such program, seamlessly to the community.
(b) Guidance on Innovative Service Delivery Systems Demonstration
Project Opportunities.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services,
through the Administrator of the Centers for Medicare & Medicaid
Services, shall issue a State Medicaid Director letter, based on best
practices developed under subsection (a)(1), regarding opportunities to
design demonstration projects under section 1115 of the Social Security
Act (42 U.S.C. 1315) to improve care transitions for certain
individuals who are soon-to-be former inmates of a public institution
and who are otherwise eligible to receive medical assistance under
title XIX of such Act, including systems for, with respect to a period
(not to exceed 30 days) immediately prior to the day on which such
individuals are expected to be released from such institution--
(1) providing assistance and education for enrollment under
a State plan under the Medicaid program under title XIX of such
Act for such individuals during such period; and
(2) providing health care services for such individuals
during such period.
(c) Rule of Construction.--Nothing under title XIX of the Social
Security Act or any other provision of law precludes a State from
reclassifying or suspending (rather than terminating) eligibility of an
individual for medical assistance under title XIX of the Social
Security Act while such individual is an inmate of a public
institution.
Subtitle E--Medicaid Partnership
SEC. 5041. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Providers Are Required
To Note Experiences in Record Systems to Help In-need Patients Act'' or
the ``Medicaid PARTNERSHIP Act''.
SEC. 5042. MEDICAID PROVIDERS ARE REQUIRED TO NOTE EXPERIENCES IN
RECORD SYSTEMS TO HELP IN-NEED PATIENTS.
(a) Requirements Under the Medicaid Program Relating to Qualified
Prescription Drug Monitoring Programs and Prescribing Certain
Controlled Substances.--Title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) is amended by inserting after section 1943 the following
new section:
``SEC. 1944. REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION DRUG
MONITORING PROGRAMS AND PRESCRIBING CERTAIN CONTROLLED
SUBSTANCES.
``(a) In General.--Beginning October 1, 2021, a State shall,
subject to subsection (d), 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.
``(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 has a contract to manage the pharmaceutical
benefit with respect to individuals enrolled in the State plan (or
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
drug management program before dispensing a controlled
substance to such individual.
``(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 Federal Matching Rate for Certain Expenditures
Relating to Qualified Prescription Drug Management Programs.--The
Secretary shall increase the Federal medical assistance percentage or
Federal matching rate that would otherwise apply to a State under
section 1903(a) for a calendar quarter occurring during the period
beginning October 1, 2018, and ending September 30, 2021, for
expenditures by the State for activities under the State plan (or
waiver of the State plan) to implement a prescription drug management
program that satisfies the criteria described in paragraphs (1) and (2)
of subsection (b) if the State (in this subsection 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 management 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. In no case shall an increase under this
subsection result in a Federal medical assistance percentage or Federal
matching rate that exceeds 100 percent.
``(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 drug management 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 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.
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 the adequacy of
access to abuse-deterrent opioid formulations for individuals with
chronic pain enrolled in an MA-PD plan under part C of title XVIII of
the Social Security Act or a prescription drug plan under part D of
such title of such Act, taking into account any barriers preventing
such individuals from accessing such formulations under such MA-PD or
part D plans, such as cost-sharing tiers, fail-first requirements, the
price of such formulations, and prior authorization requirements.
(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. SHORT TITLE.
This subtitle may be cited as the ``Medicare Opioid Safety
Education Act of 2018''.
SEC. 6022. PROVISION OF INFORMATION REGARDING OPIOID USE AND PAIN
MANAGEMENT AS PART OF MEDICARE & YOU HANDBOOK.
(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) educational resources, compiled by the Secretary,
regarding opioid use and pain management; and
``(2) a description of alternative, non-opioid pain
management treatments covered under this title.''.
(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, 2019, 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 that provides recommendations described in
subsection (b).
(b) Action Plan Components.--Recommendations described in this
subsection are, based on an examination by the Secretary of potential
obstacles to an effective response to the opioid crisis,
recommendations, as determined appropriate by the Secretary, on the
following:
(1) Recommendations on changes to the Medicare program
under title XVIII of the Social Security Act and the Medicaid
program under title XIX of such Act that would enhance coverage
and payment under such programs of all medication-assisted
treatment approved by the Food and Drug Administration for the
treatment of opioid addiction and other therapies that manage
chronic and acute pain and treat and minimize risk of opioid
addiction, including recommendations on changes to the Medicare
prospective payment system for hospital inpatient department
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. 1395l(t)) that would allow for separate
payment for such therapies, if medically appropriate and if
necessary to encourage development and adoption of such
therapies.
(2) Recommendations for payment and service delivery models
to be tested 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 addiction
and other therapies that manage chronic and acute pain and
treat and minimize risk of opioid addiction.
(3) Recommendations for data collection that could
facilitate research and policy making regarding prevention of
opioid addiction and coverage and payment under the Medicare
and Medicaid programs of appropriate opioid addiction
treatments.
(4) Recommendations for policies under the Medicare program
and under the Medicaid program that can expand access for
rural, or medically underserved communities to the full range
of medication-assisted treatment approved by the Food and Drug
Administration for the treatment of opioid addiction and other
therapies that manage chronic and acute pain and treatment and
minimize risk of opioid addiction.
(5) Recommendations on changes to the Medicare program and
the Medicaid program to address coverage or payment barriers to
patient access 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.
(c) Stakeholder Meetings.--
(1) In general.--Beginning not later than 3 months after
the date of the enactment of this Act, the Secretary shall
convene a public stakeholder meeting to solicit public comment
on the components of the action plan recommendations 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, 2019, the Secretary
shall submit to Congress, and make public, a report that includes--
(1) a summary of recommendations that have emerged under
the action plan;
(2) the Secretary's planned next steps with respect to the
action plan; and
(3) an evaluation of price trends for drugs used to reverse
opioid overdoses (such as naloxone), including recommendations
on ways to lower such prices for consumers.
(f) Definition of Medication-Assisted Treatment.--In this section,
the term ``medication-assisted treatment'' includes opioid treatment
programs, behavioral therapy, and medications to treat substance abuse
disorder.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders
in Medicare
SEC. 6041. SHORT TITLE.
This subtitle may be cited as the ``Advancing High Quality
Treatment for Opioid Use Disorders in Medicare Act''.
SEC. 6042. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is
amended by inserting after section 1866E (42 U.S.C. 1395cc-5) the
following new section:
``SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.
``(a) Implementation of 4-year Demonstration Program.--
``(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration program under
this title (in this section referred to as the `Program') to
increase access of applicable beneficiaries to opioid use
disorder treatment services, improve physical and mental health
outcomes for such beneficiaries, and to the extent possible,
reduce expenditures under this title. Under the Program, the
Secretary shall make payments under subsection (e) to
participants (as defined in subsection (c)(1)(A)) for
furnishing opioid use disorder treatment services delivered
through opioid use disorder care teams, or arranging for such
services to be furnished, to applicable beneficiaries
participating in the Program.
``(2) Opioid use disorder treatment services.--For purposes
of this section, the term `opioid use disorder treatment
services'--
``(A) means, with respect to an applicable
beneficiary, services that are furnished for the
treatment of opioid use disorders and that utilize
drugs approved under section 505 of the Federal Food,
Drug, and Cosmetic Act for the treatment of opioid use
disorders in an outpatient setting; and
``(B) includes--
``(i) medication assisted treatment;
``(ii) treatment planning;
``(iii) psychiatric, psychological, or
counseling services (or any combination of such
services), as appropriate;
``(iv) social support services, as
appropriate; and
``(v) care management and care coordination
services, including coordination with other
providers of services and suppliers not on an
opioid use disorder care team.
``(b) Program Design.--
``(1) In general.--The Secretary shall design the Program
in such a manner to allow for the evaluation of the extent to
which the Program accomplishes the following purposes:
``(A) Reduces hospitalizations and emergency
department visits.
``(B) Increases use of medication-assisted
treatment for opioid use disorders.
``(C) Improves health outcomes of individuals with
opioid use disorders, including by reducing the
incidence of infectious diseases (such as hepatitis C
and HIV).
``(D) Does not increase the total spending on items
and services under this title.
``(E) Reduces deaths from opioid overdose.
``(F) Reduces the utilization of inpatient
residential treatment.
``(2) Consultation.--In designing the Program, including
the criteria under subsection (e)(2)(A), the Secretary shall,
not later than 3 months after the date of the enactment of this
section, consult with specialists in the field of addiction,
clinicians in the primary care community, and beneficiary
groups.
``(c) Participants; Opioid Use Disorder Care Teams.--
``(1) Participants.--
``(A) Definition.--In this section, the term
`participant' means an entity or individual--
``(i) that is otherwise enrolled under this
title and that is--
``(I) a physician (as defined in
section 1861(r)(1));
``(II) a group practice comprised
of at least one physician described in
subclause (I);
``(III) a hospital outpatient
department;
``(IV) a federally qualified health
center (as defined in section
1861(aa)(4));
``(V) a rural health clinic (as
defined in section 1861(aa)(2));
``(VI) a community mental health
center (as defined in section
1861(ff)(3)(B));
``(VII) a clinic certified as a
certified community behavioral health
clinic pursuant to section 223 of the
Protecting Access to Medicare Act of
2014; or
``(VIII) any other individual or
entity specified by the Secretary;
``(ii) that applied for and was selected to
participate in the Program pursuant to an
application and selection process established
by the Secretary; and
``(iii) that establishes an opioid use
disorder care team (as defined in paragraph
(2)) through employing or contracting with
health care practitioners described in
paragraph (2)(A), and uses such team to furnish
or arrange for opioid use disorder treatment
services in the outpatient setting under the
Program.
``(B) Preference.--In selecting participants for
the Program, the Secretary shall give preference to
individuals and entities that are located in areas with
a prevalence of opioid use disorders that is higher
than the national average prevalence.
``(2) Opioid use disorder care teams.--
``(A) In general.--For purposes of this section,
the term `opioid use disorder care team' means a team
of health care practitioners established by a
participant described in paragraph (1)(A) that--
``(i) shall include--
``(I) at least one physician (as
defined in section 1861(r)(1))
furnishing primary care services or
addiction treatment services to an
applicable beneficiary; and
``(II) at least one eligible
practitioner (as defined in paragraph
(3)(A)), 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 practitioners; other provider-related
definitions and application provisions.--
``(A) Eligible practitioners.--For purposes of this
section, the term `eligible practitioner' means a
physician or other health care practitioner, such as a
nurse practitioner, that--
``(i) is enrolled under section 1866(j)(1);
``(ii) is authorized to prescribe or
dispense narcotic drugs to individuals for
maintenance treatment or detoxification
treatment; and
``(iii) 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.
``(B) Addiction specialists.--For purposes of
subsection (e)(1)(B)(iv), the term `addiction
specialist' means a physician that possesses expert
knowledge and skills in addiction medicine, as
evidenced by appropriate certification from a specialty
body, a certificate of advanced qualification in
addiction medicine, or completion of an accredited
residency or fellowship in addiction medicine or
addiction psychiatry, as determined by the Secretary.
``(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 shall--
``(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;
``(iv) pay higher per applicable
beneficiary per month care management fees for
participants that have established opioid use
disorder care teams that include an addiction
specialist (as defined in subsection
(c)(3)(B)); and
``(v) 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 the Secretary
and Congress--
``(A) a report with respect to the intermediate
evaluation under paragraph (1) not later than 3 years
after the date of the implementation of the Program;
and
``(B) a report with respect to the final evaluation
under paragraph (1) not later than 6 years after such
date.
``(h) Funding.--
``(1) Administrative funding.--For the purposes of
implementing, administering, and carrying out the Program
(other than for purposes described in paragraph (2)),
$5,000,000 shall be available from the Federal Supplementary
Medical Insurance Trust Fund under section 1841.
``(2) Care management fees and incentives.--For the
purposes of making payments under subsection (e), $10,000,000
shall be available from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 for each of fiscal
years 2021 through 2024.
``(3) Availability.--Amounts transferred under this
subsection for a fiscal year shall be available until expended.
``(i) Waivers.--The Secretary may waive any provision of this title
as may be necessary to carry out the Program under this section.''.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes
for Users' Treatment
SEC. 6051. SHORT TITLE.
This subtitle may be cited as the ``Responsible Education Achieves
Care and Healthy Outcomes for Users' Treatment Act of 2018'' or the
``REACH OUT Act of 2018''.
SEC. 6052. GRANTS TO PROVIDE TECHNICAL ASSISTANCE TO OUTLIER
PRESCRIBERS OF OPIOIDS.
(a) Grants Authorized.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall, through the
Centers for Medicare & Medicaid Services, award grants, contracts, or
cooperative agreements to eligible entities for the purposes described
in subsection (b).
(b) Use of Funds.--Grants, contracts, and cooperative agreements
awarded under subsection (a) shall be used to support eligible entities
through technical assistance--
(1) to educate and provide outreach to outlier prescribers
of opioids about best practices for prescribing opioids;
(2) to educate and provide outreach to outlier prescribers
of opioids about non-opioid pain management therapies; and
(3) to reduce the amount of opioid prescriptions prescribed
by outlier prescribers of opioids.
(c) Application.--Each eligible entity seeking to receive a grant,
contract, or cooperative agreement under subsection (a) shall submit to
the Secretary an application, at such time, in such manner, and
containing such information as the Secretary may require.
(d) Geographic Distribution.--In awarding grants, contracts, and
cooperative agreements under this section, the Secretary shall
prioritize establishing technical assistance resources in each State.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means--
(A) an organization--
(i) that has demonstrated experience
providing technical assistance to health care
professionals on a State or regional basis; and
(ii) that has at least--
(I) one individual who is a
representative of consumers on its
governing body; and
(II) one individual who is a
representative of health care providers
on its governing body; or
(B) an entity that is a quality improvement entity
with a contract under part B of title XI of the Social
Security Act (42 U.S.C. 1320c et seq.).
(2) Outlier prescriber of opioids.--The term ``outlier
prescriber of opioids'' means a prescriber, identified by the
Secretary of Health and Human Services (through use of
prescriber information provided by prescriber National Provider
Identifiers included pursuant to section 1860D-4(c)(4)(A) of
the Social Security Act (42 U.S.C. 1395w-104(c)(4)(A)) on
claims for covered part D drugs for part D eligible individuals
enrolled in prescription drug plans under part D of title XVIII
of such Act (42 U.S.C. 1395w-101 et seq.) and MA-PD plans under
part C of such title (42 U.S.C. 1395w-21 et seq.)) as
prescribing, as compared to other prescribers in the specialty
of the prescriber and geographic area, amounts of opioids in
excess of a threshold (and other criteria) specified by the
Secretary, after consultation with stakeholders.
(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.
(a) Inclusion in Electronic Prescription Program.--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.''.
(b) Sense of Congress Regarding Electronic Prior Authorization.--It
is the sense of the Congress that--
(1) there should be increased use of electronic prior
authorizations for coverage of covered part D drugs for part D
eligible individuals enrolled in prescription drug plans under
part D of title XVIII of the Social Security Act and MA-PD
plans under part C of such title to reduce access delays by
resolving coverage issues before prescriptions for such drugs
are transmitted; and
(2) greater priority should be placed on increasing the
adoption of use of such electronic prior authorizations among
prescribers of such drugs, pharmacies, PDP sponsors, and
Medicare Advantage organizations.
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 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 fraud, waste, or abuse of a
provider of services or supplier, if such
provider 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 fraud, waste, and abuse,
using guidance such as what is provided in the Medicare
Program Integrity Manual 4.7.1. 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 2 years after the date
of enactment of this subsection, the Secretary shall make
available to MA plans under this part and prescription drug
plans under part D in a timely manner (but no less frequently
than quarterly) and using information submitted to an entity
described in paragraph (1) through the portal (or other
successor technology) described in such paragraph or pursuant
to section 1893, information on fraud, waste, and abuse schemes
and trends in identifying suspicious activity. Information
included in each such report shall--
``(A) include administrative actions, pertinent
information related to opioid overprescribing, and
other data determined appropriate by the Secretary in
consultation with stakeholders; and
``(B) be anonymized information submitted by plans
without identifying the source of such information.
``(3) Clarification.--Nothing in this subsection shall be
construed as precluding or otherwise affecting referrals
described in subparagraph (A) that may otherwise be made to law
enforcement entities or to the Secretary.''.
(b) Contract Requirement to Communicate Plan Corrective Actions
Against Opioid 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 and other actions taken by such
plans related to providers of services who prescribe a
high volume 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
`high volume of opioids' and a method for
determining if a provider of services
prescribes such a high volume; and
``(ii) establish the process described in
subparagraph (B) and the types of information
that 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. MEDICARE NOTIFICATIONS TO OUTLIER PRESCRIBERS OF OPIOIDS.
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) Outlier prescriber notification.--
``(i) Notification.--Beginning not later
than 2 years after the date of the enactment of
this subparagraph, 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 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 threshold established under
subclause (II), conduct an analysis to
identify prescribers that are outlier
opioid prescribers for a period
specified by the Secretary.
``(II) Establishment of
threshold.--For purposes of subclause
(I) and subject to subclause (III), the
Secretary shall, after consultation
with stakeholders, establish a
threshold, 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 Secretary
may exclude the following individuals
and prescribers from the analysis under
this clause:
``(aa) Individuals
receiving hospice services.
``(bb) Individuals with a
cancer diagnosis.
``(cc) Prescribers who are
the subject of an investigation
by the Centers for Medicare &
Medicaid Services or the Office
of Inspector General of the
Department of Health and Human
Services.
``(iii) Contents of notification.--The
Secretary shall, based on input from
stakeholders, specify the resources and other
information to be included in notifications
provided under clause (i).
``(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.
``(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) Opioids defined.--For purposes of
this subparagraph, the term `opioids' has such
meaning as specified by the Secretary through
program instruction or otherwise.''.
SEC. 6066. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle and the amendments made by this
subtitle. Such requirements shall be carried out using amounts
otherwise authorized to be appropriated.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
SEC. 6071. SHORT TITLE.
This subtitle may be cited as the ``Expanding Oversight of Opioid
Prescribing and Payment Act of 2018''.
SEC. 6072. MEDICARE PAYMENT ADVISORY COMMISSION REPORT ON OPIOID
PAYMENT, ADVERSE INCENTIVES, AND DATA UNDER THE MEDICARE
PROGRAM.
Not later than March 15, 2019, the Medicare Payment Advisory
Commission shall submit to Congress a report on, with respect to the
Medicare program under title XVIII of the Social Security Act, the
following:
(1) A description of how the Medicare program pays for pain
management treatments (both opioid and non-opioid pain
management alternatives) in both inpatient and outpatient
hospital settings.
(2) The identification of incentives under the hospital
inpatient prospective payment system under section 1886 of the
Social Security Act (42 U.S.C. 1395ww) and incentives under the
hospital outpatient prospective payment system under section
1833(t) of such Act (42 U.S.C. 1395l(t)) for prescribing
opioids and incentives under each such system for prescribing
non-opioid treatments, and recommendations as the Commission
deems appropriate for addressing any of such incentives that
are adverse incentives.
(3) A description of how opioid use is tracked and
monitored through Medicare claims data and other mechanisms and
the identification of any areas in which further data and
methods are needed for improving data and understanding of
opioid use.
SEC. 6073. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this subtitle. Such requirements shall be carried
out using amounts otherwise authorized to be appropriated.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
SEC. 6081. SHORT TITLE.
This subtitle may be cited as the ``Dr. Todd Graham Pain
Management, Treatment, and Recovery Act of 2018''.
SEC. 6082. REVIEW AND ADJUSTMENT OF PAYMENTS UNDER THE MEDICARE
OUTPATIENT PROSPECTIVE PAYMENT SYSTEM TO AVOID FINANCIAL
INCENTIVES TO USE OPIOIDS INSTEAD OF NON-OPIOID
ALTERNATIVE TREATMENTS.
(a) Outpatient Prospective Payment System.--Section 1833(t) of the
Social Security Act (42 U.S.C. 1395l(t)) is amended by adding at the
end the following new paragraph:
``(22) Review and revisions of payments for non-opioid
alternative treatments.--
``(A) In general.--With respect to payments made
under this subsection for covered OPD services (or
groups of services), including covered OPD services
assigned to a comprehensive ambulatory payment
classification, the Secretary--
``(i) shall, as soon as practicable,
conduct a review (part of which may include a
request for information) of payments for
opioids and evidence-based non-opioid
alternatives for pain management (including
drugs and devices, nerve blocks, surgical
injections, and neuromodulation) with a goal of
ensuring that there are not financial
incentives to use opioids instead of non-opioid
alternatives;
``(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews of such
payments; and
``(iii) shall consider the extent to which
revisions under this subsection to such
payments (such as the creation of additional
groups of covered OPD services to classify
separately those procedures that utilize
opioids and non-opioid alternatives for pain
management) would reduce payment incentives to
use opioids instead of non-opioid alternatives
for pain management.
``(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering
revisions under clause (iii) of such subparagraph, the
Secretary shall focus on covered OPD services (or
groups of services) assigned to a comprehensive
ambulatory payment classification, ambulatory payment
classifications that primarily include surgical
services, and other services determined by the
Secretary which generally involve treatment for pain
management.
``(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph
(A)(iii), the Secretary shall, as determined
appropriate, begin making such revisions for services
furnished on or after January 1, 2020. Revisions under
the previous sentence shall be treated as adjustments
for purposes of application of paragraph (9)(B).
``(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the
Secretary--
``(i) from conducting a demonstration
before making the revisions described in
subparagraph (C); or
``(ii) prior to implementation of this
paragraph, from changing payments under this
subsection for covered OPD services (or groups
of services) which include opioids or non-
opioid alternatives for pain management.''.
(b) Ambulatory Surgical Centers.--Section 1833(i) of the Social
Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the
following new paragraph:
``(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including the second
sentence of subparagraph (C) of such paragraph, to payment for services
under this subsection, and make such revisions under this paragraph, in
an appropriate manner (as determined by the Secretary).''.
SEC. 6083. EXPANDING ACCESS UNDER THE MEDICARE PROGRAM TO ADDICTION
TREATMENT IN FEDERALLY QUALIFIED HEALTH CENTERS AND RURAL
HEALTH CLINICS.
(a) Federally Qualified Health Centers.--Section 1834(o) of the
Social Security Act (42 U.S.C. 1395m(o)) is amended by adding at the
end the following new paragraph:
``(3) Additional payments for certain fqhcs with physicians
or other practitioners receiving data 2000 waivers.--
``(A) In general.--In the case of a Federally
qualified health center with respect to which,
beginning on or after January 1, 2019, Federally-
qualified health center services (as defined in section
1861(aa)(3)) are furnished for the treatment of opioid
use disorder by a physician or practitioner who meets
the requirements described in subparagraph (C) the
Secretary shall, subject to availability of funds under
subparagraph (D), make a payment (at such time and in
such manner as specified by the Secretary) to such
Federally qualified health center after receiving and
approving an application submitted by such Federally
qualified health center under subparagraph (B). Such a
payment shall be in an amount determined by the
Secretary, based on an estimate of the average costs of
training for purposes of receiving a waiver described
in subparagraph (C)(ii). Such a payment may be made
only one time with respect to each such physician or
practitioner.
``(B) Application.--In order to receive a payment
described in subparagraph (A), a Federally-qualified
health center shall submit to the Secretary an
application for such a payment at such time, in such
manner, and containing such information as specified by
the Secretary. A Federally-qualified health center may
apply for such a payment for each physician or
practitioner described in subparagraph (A) furnishing
services described in such subparagraph at such center.
``(C) Requirements.--For purposes of subparagraph
(A), the requirements described in this subparagraph,
with respect to a physician or practitioner, are the
following:
``(i) The physician or practitioner is
employed by or working under contract with a
Federally qualified health center described in
subparagraph (A) that submits an application
under subparagraph (B).
``(ii) The physician or practitioner first
receives a waiver under section 303(g) of the
Controlled Substances Acton 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 Acton or after January 1, 2019.
``(4) Funding.--For purposes of making payments under this
subsection, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $2,000,000, which shall
remain available until expended.''.
SEC. 6084. STUDYING THE AVAILABILITY OF SUPPLEMENTAL BENEFITS DESIGNED
TO TREAT OR PREVENT SUBSTANCE USE DISORDERS UNDER
MEDICARE ADVANTAGE PLANS.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall submit to Congress
a report on the availability of supplemental health care benefits (as
described in section 1852(a)(3)(A) of the Social Security Act (42
U.S.C. 1395w-22(a)(3)(A))) designed to treat or prevent substance use
disorders under Medicare Advantage plans offered under part C of title
XVIII of such Act. Such report shall include the analysis described in
subsection (c) and any differences in the availability of such benefits
under specialized MA plans for special needs individuals (as defined in
section 1859(b)(6) of such Act (42 U.S.C. 1395w-28(b)(6))) offered to
individuals entitled to medical assistance under title XIX of such Act
and other such Medicare Advantage plans.
(b) Consultation.--The Secretary shall develop the report described
in subsection (a) in consultation with relevant stakeholders,
including--
(1) individuals entitled to benefits under part A or
enrolled under part B of title XVIII of the Social Security
Act;
(2) entities who advocate on behalf of such individuals;
(3) Medicare Advantage organizations;
(4) pharmacy benefit managers; and
(5) providers of services and suppliers (as such terms are
defined in section 1861 of such Act (42 U.S.C. 1395x)).
(c) Contents.--The report described in subsection (a) shall include
an analysis on the following:
(1) The extent to which plans described in such subsection
offer supplemental health care benefits relating to coverage
of--
(A) medication-assisted treatments for opioid use,
substance use disorder counseling, peer recovery
support services, or other forms of substance use
disorder treatments (whether furnished in an inpatient
or outpatient setting); and
(B) non-opioid alternatives for the treatment of
pain.
(2) Challenges associated with such plans offering
supplemental health care benefits relating to coverage of items
and services described in subparagraph (A) or (B) of paragraph
(1).
(3) The impact, if any, of increasing the applicable rebate
percentage determined under section 1854(b)(1)(C) of the Social
Security Act (42 U.S.C. 1395w-24(b)(1)(C)) for plans offering
such benefits relating to such coverage would have on the
availability of such benefits relating to such coverage offered
under Medicare Advantage plans.
(4) Potential ways to improve upon such coverage or to
incentivize such plans to offer additional supplemental health
care benefits relating to such coverage.
SEC. 6085. CLINICAL PSYCHOLOGIST SERVICES MODELS UNDER THE CENTER FOR
MEDICARE AND MEDICAID INNOVATION; GAO STUDY AND REPORT.
(a) CMI Models.--Section 1115A(b)(2)(B) of the Social Security Act
(42 U.S.C. 1315a(b)(2)(B) is amended by adding at the end the following
new clauses:
``(xxv) 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)).
``(xxvi) 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. 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) Medical devices, non-opioid based drugs, and
other therapies (including interventional and
integrative pain therapies) approved or cleared by the
Food and Drug Administration for the treatment of pain.
(F) 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 (F) of paragraph
(1).
(B) Costs and benefits associated with potential
expansion of coverage under such title to include items
and services not covered under such title that may be
used for the treatment of pain, such as acupuncture,
therapeutic massage, and items and services furnished
by integrated pain management programs.
(C) Pain management guidance published by the
Federal Government that may be relevant to coverage
determinations or other coverage requirements under
title XVIII of the Social Security Act.
(3) An assessment of all guidance published by the
Department of Health and Human Services on or after January 1,
2016, relating to the prescribing of opioids. Such assessment
shall consider incorporating into such guidance relevant
elements of the ``Va/DoD Clinical Practice Guideline for Opioid
Therapy for Chronic Pain'' published in February 2017 by the
Department of Veterans Affairs and Department of Defense,
including adoption of elements of the Department of Defense and
Department of Veterans Affairs pain rating scale.
(4) The options described in subsection (d).
(5) The impact analysis described in subsection (e).
(d) Options.--The options described in this subsection are, with
respect to individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act, legislative and
administrative options for accomplishing the following:
(1) Improving coverage of and payment for pain management
therapies without the use of opioids, including interventional
pain therapies, and options to augment opioid therapy with
other clinical and complementary, integrative health services
to minimize the risk of substance use disorder, including in a
hospital setting.
(2) Improving coverage of and payment for medical devices
and non-opioid based pharmacological and non-pharmacological
therapies approved or cleared by the Food and Drug
Administration for the treatment of pain as an alternative or
augment to opioid therapy.
(3) Improving and disseminating treatment strategies for
beneficiaries with psychiatric disorders, substance use
disorders, or who are at risk of suicide, and treatment
strategies to address health disparities related to opioid use
and opioid abuse treatment.
(4) Improving and disseminating treatment strategies for
beneficiaries with comorbidities who require a consultation or
comanagement of pain with one or more specialists in pain
management, mental health, or addiction treatment, including in
a hospital setting.
(5) Educating providers on risks of coadministration of
opioids and other drugs, particularly benzodiazepines.
(6) Ensuring appropriate case management for beneficiaries
who transition between inpatient and outpatient hospital
settings, or between opioid therapy to non-opioid therapy,
which may include the use of care transition plans.
(7) Expanding outreach activities designed to educate
providers of services and suppliers under the Medicare program
and individuals entitled to benefits under part A or under part
B of such title on alternative, non-opioid therapies to manage
and treat acute and chronic pain.
(8) Creating a beneficiary education tool on alternatives
to opioids for chronic pain management.
(e) Impact Analysis.--The impact analysis described in this
subsection consists of an analysis of any potential effects
implementing the options described in subsection (d) would have--
(1) on expenditures under the Medicare program; and
(2) on preventing or reducing opioid addiction for
individuals receiving benefits under the Medicare program.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
SEC. 6091. SHORT TITLE.
This subtitle may be cited as the ``Combating Opioid Abuse for Care
in Hospitals Act of 2018'' or the ``COACH Act of 2018''.
SEC. 6092. DEVELOPING GUIDANCE ON PAIN MANAGEMENT AND OPIOID USE
DISORDER PREVENTION FOR HOSPITALS RECEIVING PAYMENT UNDER
PART A OF THE MEDICARE PROGRAM.
(a) In General.--Not later than January 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.
(a) In General.--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).''.
(b) Expedited Endorsement Process for Opioid Measures.--Section
1890(b)(2) of the Social Security Act (42 U.S.C. 1395aaa(b)(2)) is
amended by adding at the end the following new flush sentence:
``Such endorsement process shall, as determined practicable by
the entity, provide for an expedited process with respect to
the endorsement of such measures relating to opioids and opioid
use disorders.''.
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 recommendations
for the development of an evaluation and management
code for purposes of payment under the Medicare program
under title XVIII of the Social Security Act that would
account for time spent on shared decision making.
(C) Education on the safe use, storage, and
disposal of opioids.
(D) Prevention of opioid misuse and abuse after
discharge.
(E) Development of a clinical algorithm to identify
and treat at-risk, opiate-tolerant patients and reduce
reliance on opioids for acute pain during the
perioperative period.
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to Congress
and make public a report containing the recommendations
developed under paragraph (1) and an action plan for broader
implementation of pain management protocols that limit the use
of opioids in the perioperative setting and upon discharge from
such setting.
(b) Data Collection on Perioperative Opioid Use.--Not later than 1
year after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a report that
contains the following:
(1) The diagnosis-related group codes identified by the
Secretary as having the highest volume of surgeries.
(2) With respect to each of such diagnosis-related group
codes so identified, a determination by the Secretary of the
data that is both available and reported on opioid use
following such surgeries, such as with respect to--
(A) surgical volumes, practices, and opioid
prescribing patterns;
(B) opioid consumption, including--
(i) perioperative days of therapy;
(ii) average daily dose at the hospital,
including dosage greater than 90 milligram
morphine equivalent;
(iii) post-discharge prescriptions and
other combination drugs that are used before
intervention and after intervention;
(iv) quantity and duration of opioid
prescription at discharge; and
(v) quantity consumed and number of
refills;
(C) regional anesthesia and analgesia practices,
including pre-surgical and post-surgical injections;
(D) naloxone reversal;
(E) post-operative respiratory failure;
(F) information about storage and disposal; and
(G) such other information as the Secretary may
specify.
(3) Recommendations for improving data collection on
perioperative opioid use, including an analysis to identify and
reduce barriers to collecting, reporting, and analyzing the
data described in paragraph (2), including barriers related to
technological availability.
SEC. 6095. REQUIRING THE POSTING AND PERIODIC UPDATE OF OPIOID
PRESCRIBING GUIDANCE FOR MEDICARE BENEFICIARIES.
(a) In General.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall post on the public
website of the Centers for Medicare & Medicaid Services all guidance
published by the Department of Health and Human Services on or after
January 1, 2016, relating to the prescribing of opioids and applicable
to opioid prescriptions for individuals entitled to benefits under part
A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.)
or enrolled under part B of such title of such Act (42 U.S.C. 1395j et
seq.).
(b) Update of Guidance.--
(1) Periodic update.--The Secretary shall, in consultation
with the entities specified in paragraph (2), periodically (as
determined appropriate by the Secretary) update guidance
described in subsection (a) and revise the posting of such
guidance on the website described in such subsection.
(2) Consultation.--The entities specified in this paragraph
are the following:
(A) Medical professional organizations.
(B) Providers and suppliers of services (as such
terms are defined in section 1861 of the Social
Security Act (42 U.S.C. 1395x)).
(C) Health care consumers or groups representing
such consumers.
(D) Other entities determined appropriate by the
Secretary.
Subtitle K--Stop Excessive Narcotics in Our Retirement Communities
Protection
SEC. 6101. SHORT TITLE.
This subtitle may be cited as the ``Stop Excessive Narcotics in our
Retirement Communities Protection Act of 2018'' or the ``SENIOR
Communities Protection Act of 2018''.
SEC. 6102. 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.--The provisions of section
1862(o) 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 provisions apply with respect to the Secretary, a
provider of services or supplier, and payments to such
provider of services or supplier under this title.
``(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.
Subtitle L--Providing Reliable Options for Patients and Educational
Resources
SEC. 6111. 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. 6112. 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. 6113. 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. 6114. 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, 2019, 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 about communication by hospital staff with an individual about
such individual's pain.''.
(b) Restriction on Use of 2018 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 about communication by hospital staff with
an individual about the individual's pain.''.
TITLE VII--OTHER HEALTH PROVISIONS
Subtitle A--Synthetic Drug Awareness
SEC. 7001. SHORT TITLE.
This subtitle may be cited as the ``Synthetic Drug Awareness Act of
2018''.
SEC. 7002. 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 Surgeon General of the Public Health Service
shall submit to Congress a report on the health effects of new
psychoactive substances (including synthetic drugs) used since January
2010 by persons who are at least 12 years of age but no more than 18
years of age.
(b) New Psychoactive Substance Defined.--For purposes of subsection
(a), the term ``new psychoactive substance'' means a controlled
substance analogue (as defined in section 102(32) of the Controlled
Substances Act (21 U.S.C. 802(32)).
Subtitle B--Empowering Pharmacists in the Fight Against Opioid Abuse
SEC. 7011. SHORT TITLE.
This subtitle may be cited as the ``Empowering Pharmacists in the
Fight Against Opioid Abuse Act''.
SEC. 7012. 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, the Commissioner of Food and Drugs, the Director of the
Centers for Disease Control and Prevention, and the Assistant Secretary
for Mental Health and Substance Use, shall develop and disseminate
programs and materials for training pharmacists, health care providers,
and patients on--
(1) circumstances under which a pharmacist may, consistent
with section 201 of the Controlled Substances Act (21 U.S.C.
811) and regulations thereunder, including section 1306.04 of
title 21, Code of Federal Regulations, decline to fill a
prescription for a controlled substance because the pharmacist
suspects the prescription is fraudulent, forged, or otherwise
indicative of abuse or diversion; and
(2) any Federal requirements pertaining to declining to
fill a prescription under such circumstances.
(b) Materials Included.--In developing materials under subsection
(a), the Secretary of Health and Human Services shall include
information educating--
(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 responsibility to decline to fill prescriptions in
certain circumstances.
(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.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
SEC. 7021. SHORT TITLE.
This subtitle may be cited as the ``Indexing Narcotics, Fentanyl,
and Opioids Act of 2018'' or the ``INFO Act''.
SEC. 7022. 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 a public information
dashboard that--
``(1) coordinates information on programs within the
Department of Health and Human Services related to the
reduction of opioid abuse and other substance use disorders;
``(2) provides access to publicly available data from other
Federal agencies; State, local, and Tribal governments;
nonprofit organizations; law enforcement; medical experts;
public health educators; and research institutions regarding
prevention, treatment, recovery, and other services for opioid
use disorder and other substance use disorders;
``(3) provides comparable data on substance use disorder
prevention and treatment strategies in different regions and
population of the United States;
``(4) provides recommendations for health care providers on
alternatives to controlled substances for pain management,
including approaches studied by the National Institutes of
Health Pain Consortium and the National Center for
Complimentary and Integrative Health; and
``(5) provides 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. 7023. INTERAGENCY SUBSTANCE USE DISORDER 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 consultation
with the Director of National Drug Control Policy, establish a
committee, to be known as the Interagency Substance Use Disorder
Coordinating Committee (in this section referred to as the
``Committee'' ), to coordinate all efforts within the Department of
Health and Human Services concerning substance use disorder.
(b) Membership.--
(1) Federal members.--The following individuals shall be
the Federal members of the Committee:
(A) The Secretary, who shall service as the Chair
of the Committee.
(B) The Attorney General of the United States.
(C) The Secretary of Labor.
(D) The Secretary of Housing and Urban Development.
(E) The Secretary of Education.
(F) The Secretary of Veterans Affairs.
(G) The Commissioner of Social Security.
(H) The Assistant Secretary for Mental Health and
Substance Use.
(I) The Director of the Centers for Disease Control
and Prevention.
(J) The Director of the National Institutes of
Health and the Directors of such national research
institutes of the National Institutes of Health as the
Secretary determines appropriate.
(K) The Administrator of the Centers for Medicare &
Medicaid Services.
(L) The Director of National Drug Control Policy.
(M) Representatives of other Federal agencies that
serve individuals with substance use disorder.
(2) Non-federal members.--The Committee shall include a
minimum of 17 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 an opioid use disorder;
(B) at least two such members shall be an
individual who has received treatment for a diagnosis
of a substance use disorder other than an opioid use
disorder;
(C) at least two such members shall be a State
Alcohol and Substance Abuse Director;
(D) at least two such members shall be a
representative of a leading research, advocacy, or
service organization for adults with substance use
disorder;
(E) 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 opioid use disorder or other
substance use disorders;
(F) at least one such member shall be a substance
use disorder treatment professional who is employed
with an opioid treatment program;
(G) 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;
(H) 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;
(I) at least one such member shall be a State-
certified substance use disorder peer support
specialist;
(J) at least one such member shall be a drug court
judge or a judge with experience in adjudicating cases
related to substance use disorder;
(K) at least one such member shall be a law
enforcement officer or correctional officer with
extensive experience in interacting with adults with a
substance use disorder; and
(L) at least one such member shall be an individual
with experience providing services for homeless
individuals and working with adults 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) monitor opioid use disorder and other substance use
disorder research, services, and support and prevention
activities across all relevant Federal agencies, including
coordination of Federal activities with respect to opioid use
disorder and other substance use disorders;
(2) identify and provide to the Secretary recommendations
for improving Federal grants and programs for the prevention
and treatment of, and recovery from, opioid use disorder and
other substance use disorders;
(3) review substance use disorder prevention and treatment
strategies in different regions 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 opioid use disorder and
other substance use disorders and the process by which public
feedback can be better integrated into such decisions; and
(6) make recommendations to ensure that opioid use disorder
and other substance use disorder research, services, and
support and prevention activities of the Department of Health
and Human Services and other Federal agencies are not
unnecessarily duplicative.
(f) Annual Report.--
(1) In general.--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 public
information dashboard established under section 7022(a) a
report summarizing the activities carried out by the Committee
pursuant to subsection (e), including any findings resulting
from such activities.
(2) Recommendation for committee extension.--After the
publication of the second report of the Committee under
paragraph (1), the Secretary shall submit to Congress a
recommendation on whether or not the operations of the
Committee should continue after the termination date described
in subsection (i).
(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).
Subtitle D--Ensuring Access to Quality Sober Living
SEC. 7031. SHORT TITLE.
This subtitle may be cited as the ``Ensuring Access to Quality
Sober Living Act of 2018''.
SEC. 7032. NATIONAL RECOVERY HOUSING BEST PRACTICES.
Part P of title III of the Public Health Service Act is amended by
adding at the end the following new section:
``SEC. 399V-7. NATIONAL RECOVERY HOUSING BEST PRACTICES.
``(a) Best Practices.--The Secretary of Health and Human Services,
in consultation with the Secretary for Housing and Urban Development,
patients with a history of opioid use disorder, and other stakeholders,
which may include State accrediting entities and reputable providers,
analysts, and stakeholders of recovery housing services, such as the
National Alliance for Recovery Residences, shall identify or facilitate
the development of best practices, which may include model laws for
implementing suggested minimum standards, for operating recovery
housing.
``(b) Dissemination.--The Secretary shall disseminate the best
practices identified or developed under subsection (a) to--
``(1) State agencies, which may include the provision of
technical assistance to State agencies seeking to adopt or
implement such best practices;
``(2) recovery housing entities; and
``(3) the public, as appropriate.
``(c) 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, including
medication-assisted treatment services, that promote sustained
recovery from substance use disorders.
``(2) The term `State' includes any of the several States,
the District of Columbia, each Indian tribe or tribal
organization (as those terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act), and
any territory or possession of the United States.
``(d) 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. SHORT TITLE.
This subtitle may be cited as the ``Advancing Cutting Edge Research
Act'' or the ``ACE Research Act''.
SEC. 7042. 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.''.
Subtitle F--Jessie's Law
SEC. 7051. SHORT TITLE.
This subtitle may be cited as ``Jessie's Law''.
SEC. 7052. 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 consultation with appropriate stakeholders,
including a patient with a history of opioid use disorder, an
expert in electronic health records, an expert in the
confidentiality of patient health information and records, and
a health care provider, shall identify or facilitate the
development of best practices regarding--
(A) the circumstances under which information that
a patient has provided to a health care provider
regarding such patient's history of opioid use disorder
should, only at the patient's request, be prominently
displayed in the medical records (including electronic
health records) of such patient;
(B) what constitutes the patient's request for the
purpose described in subparagraph (A); and
(C) the process and methods by which the
information should be so displayed.
(2) Dissemination.--The Secretary shall disseminate the
best practices developed under paragraph (1) to health care
providers and State agencies.
(b) Requirements.--In identifying or facilitating the development
of best practices under subsection (a), as applicable, the Secretary,
in consultation with appropriate stakeholders, shall consider the
following:
(1) The potential for addiction relapse or overdose,
including overdose death, when opioid medications are
prescribed to a patient recovering from opioid use disorder.
(2) The benefits of displaying information about a
patient's opioid use disorder history in a manner similar to
other potentially lethal medical concerns, including drug
allergies and contraindications.
(3) The importance of prominently displaying information
about a patient's opioid use disorder when a physician or
medical professional is prescribing medication, including
methods for avoiding alert fatigue in providers.
(4) The importance of a variety of appropriate medical
professionals, including physicians, nurses, and pharmacists,
to have 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. 7053. COMMUNICATION WITH FAMILIES DURING EMERGENCIES.
(a) Promoting Awareness of Authorized Disclosures During
Emergencies.--The Secretary of Health and Human Services, acting
through the Administrator of the Centers for Medicare & Medicaid
Services and the Administrator of the Health Resources and Services
Administration, shall annually develop and disseminate written
materials (electronically or by other means) to 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 11004 of the 21st Century Cures Act (42 U.S.C.
1320d-2 note).
Subtitle G--Safe Disposal of Unused Medication
SEC. 7061. SHORT TITLE.
This subtitle may be cited as the ``Safe Disposal of Unused
Medication Act''.
SEC. 7062. DISPOSAL OF CONTROLLED SUBSTANCES OF A DECEASED HOSPICE
PATIENT BY EMPLOYEES OF A QUALIFIED HOSPICE PROGRAM.
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 after the death of such person, so long as such disposal
occurs onsite in accordance with all applicable Federal, State, Tribal,
and local law.
``(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, 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.''.
Subtitle H--Substance Use Disorder Workforce Loan Repayment
SEC. 7071. SHORT TITLE.
This subtitle may be cited as the ``Substance Use Disorder
Workforce Loan Repayment Act of 2018''.
SEC. 7072. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT
EMPLOYEES.
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 EMPLOYEES
``SEC. 781. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT
EMPLOYEES.
``(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 complete a period of
service in a substance use disorder treatment job, 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 job.
``(2) Any loan under part E of title VIII (relating to
nursing student loans).
``(3) Any Federal Direct Stafford Loan, Federal Direct PLUS
Loan, or 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) Period of Service.--The period of service required by an
agreement under subsection (a) shall consist of up to 6 years of full-
time employment, with no more than 1 year passing between any 2 years
of covered employment, in a substance use disorder treatment job in the
United States in--
``(1) a Mental Health Professional Shortage Area, as
designated under section 332; or
``(2) a county (or a municipality, if not contained within
any county) where the mean drug overdose death rate per 100,000
people over the past 3 years for which official data is
available from the State, is higher than the most recent
available national average overdose death rate per 100,000
people, as reported by the Centers for Disease Control and
Prevention.
``(e) Ineligibility for Double Benefits.--No borrower may, for the
same service, receive a reduction of loan obligations or a loan
repayment under both--
``(1) this subsection; 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 the Substance Use Disorder Workforce Loan Repayment Act of
2018, 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 term `municipality' means a city, town, or other
public body created by or pursuant to State law, or an Indian
Tribe.
``(2) The term `substance use disorder treatment job' means
a full-time job (including a fellowship)--
``(A) where the primary intent and function of the
job is the direct treatment or recovery support of
patients with or in recovery from a substance use
disorder, such as a physician, physician assistant,
registered nurse, nurse practitioner, advanced practice
registered nurse, social worker, recovery coach, mental
health counselor, addictions counselor, psychologist or
other behavioral health professional, or any other
relevant professional as determine by the Secretary;
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 a 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 2028.''.
Subtitle I--Preventing Overdoses While in Emergency Rooms
SEC. 7081. SHORT TITLE.
This subtitle may be cited as the ``Preventing Overdoses While in
Emergency Rooms Act of 2018''.
SEC. 7082. PROGRAM TO SUPPORT EMERGENCY ROOM DISCHARGE AND CARE
COORDINATION FOR DRUG OVERDOSE PATIENTS.
(a) In General.--The Secretary of Health and Human Services shall
establish a program (in this subtitle referred to as the ``Program'')
to develop protocols for discharging patients who have presented with a
drug overdose and enhance the integration and coordination of care and
treatment options for individuals with substance use disorder after
discharge.
(b) Grant Establishment and Participation.--
(1) In general.--In carrying out the Program, the Secretary
shall award grants on a competitive basis to not more than 20
eligible entities described in paragraph (2).
(2) Eligibility.--
(A) In general.--To be eligible for a grant under
this subsection, an entity shall be--
(i) a health care site described in
subparagraph (B); or
(ii) a health care site coordinator
described in subparagraph (C).
(B) Health care sites.--To be eligible for a grant
under this section, a health care site shall--
(i) submit an application to the Secretary
at such time, in such manner, and containing
such information as specified by the Secretary;
(ii) have an emergency department;
(iii)(I) have a licensed health care
professional onsite who has a waiver under
section 303(g) of the Controlled Substances Act
(21 U.S.C. 823(g)) to dispense or prescribe
covered drugs; or
(II) have a demonstrable plan to hire a
sufficient number of full-time licensed health
care professionals who have waivers described
in subclause (I) to administer such treatment
onsite;
(iv) have in place an agreement with a
sufficient number and range of entities
certified under applicable State and Federal
law, such as pursuant to registration or a
waiver under section 303(g) of the Controlled
Substances Act (21 U.S.C. 823(g)) or
certification as described in section 8.2 of
title 42 of the Code of Federal Regulations, to
provide treatment for substance use disorder
such that the entity or the resulting network
of entities with an agreement with the hospital
cumulatively are capable of providing all
evidence-based services for the treatment of
substance use disorder, as medically
appropriate for the individual involved,
including--
(I) medication-assisted treatment;
(II) withdrawal and detoxification
services that include patient
evaluation, stabilization, and
readiness for and entry into treatment;
and
(III) counseling;
(v) deploy onsite peer recovery specialists
to help connect patients with treatment and
recovery support services; and
(vi) include the provision of overdose
reversal medication in discharge protocols for
opioid overdose patients.
(C) Health care site coordinators.--To be eligible
for a grant under this section, a health care site
coordinator shall--
(i) be an organization described in section
501(c)(3) of the Internal Revenue Code of 1986
(and exempt from tax under section 501(a) of
such Code) or a State, local, or Tribal
government;
(ii) submit an application to the Secretary
at such time, in such manner, and containing
such information as specified by the Secretary;
and
(iii) have an agreement with multiple
eligible health care sites described in
subparagraph (B).
(3) Preference.--In awarding grants under this section, the
Secretary may give preference to eligible entities described in
paragraph (2) that meet either or both of the following
criteria:
(A) The eligible health care site is, or the
eligible health care site coordinator has an agreement
described in paragraph (2)(C)(iii) with a site that is,
a critical access hospital (as defined in section
1861(mm)(1) of the Social Security Act (42 U.S.C.
1395x(mm)(1))), a low-volume hospital (as defined in
section 1886(d)(12)(C)(i) of such Act (42 U.S.C.
1395ww(d)(12)(C)(i))), or a sole community hospital (as
defined in section 1886(d)(5)(D)(iii) of such Act (42
U.S.C. 1395ww(d)(5)(D)(iii))).
(B) The eligible health care site or the eligible
health care site coordinator is located in a geographic
area with a drug overdose rate that is higher than the
national rate, or in a geographic area with a rate of
emergency department visits for overdoses that is
higher than the national rate, as determined by the
Secretary based on the most recent data from the
Centers for Disease Control and Prevention.
(4) Medication-assisted treatment defined.--For purposes of
this section, the term ``medication-assisted treatment'' means
the use of a drug approved under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological
product licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262), in combination with behavioral health
services, to provide an individualized approach to the
treatment of substance use disorders, including opioid use
disorders.
(c) Period of Grant.--A grant awarded to an eligible entity under
this section shall be for a period of at least 2 years.
(d) Grant Uses.--
(1) Required uses.--A grant awarded under this section to
an eligible entity shall be used for both of the following
purposes:
(A) To establish policies and procedures that
address the provision of overdose reversal medication,
prescription and dispensing of medication-assisted
treatment to an emergency department patient who has
had a non-fatal overdose or who is at risk of a drug
overdose, and the subsequent referral to evidence-based
treatment upon discharge for patients who have
experienced a non-fatal drug overdose or who are at
risk of a drug overdose.
(B) To develop best practices for treating non-
fatal drug overdoses, including with respect to care
coordination and integrated care models for long term
treatment and recovery options for individuals who have
experienced a non-fatal drug overdose.
(2) Additional permissible uses.--A grant awarded under
this section to an eligible entity may be used for any of the
following purposes:
(A) To hire emergency department peer recovery
specialists; counselors; therapists; social workers; or
other licensed medical professionals specializing in
the treatment of substance use disorder.
(B) To 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 treatment facilities.
(C) To provide for options for increasing the
availability and access of medication-assisted
treatment and other evidence-based treatment for
individuals with substance use disorders.
(D) To offer consultation with and referral to
other supportive services that help in treatment and
recovery.
(e) 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 at the site
(or, in the case of an eligible health care site
coordinator, at sites covered by the agreement referred
to in subsection (b)(2)(C)(iii)) for non-fatal
overdoses in the emergency department;
(B) the number of individuals administered each
medication-assisted treatment at such site or sites in
the emergency department;
(C) the number of individuals referred by such site
or sites 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;
(D) the frequency and number of patient
readmissions for non-fatal overdoses and substance use
disorder;
(E) for what the grant funding was used; and
(F) the effectiveness of, and any other relevant
additional data regarding, having an onsite health care
professional to administer and begin medication-
assisted treatment for substance use disorders.
(2) Report by secretary.--Not less than 1 year after the
conclusion of the Program, the Secretary shall submit to
Congress a report that includes--
(A) findings of the Program;
(B) overall patient outcomes under the Program,
such as with respect to hospital readmission;
(C) what percentage of patients treated by a site
funded through a grant under this section were
readmitted to a hospital for non-fatal or fatal
overdose;
(D) an evaluation determining the effectiveness of
having a practitioner onsite to administer and begin
medication-assisted treatment for substance use
disorder; and
(E) a compilation of voluntary guidelines and best
practices from the reports submitted under paragraph
(1).
(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this subtitle $50,000,000 for the period of
fiscal years 2019 through 2023.
Subtitle J--Alternatives to Opioids in the Emergency Department
SEC. 7091. SHORT TITLE.
This subtitle may be cited as the ``Alternatives to Opioids in the
Emergency Department Act'' or the ``ALTO Act''.
SEC. 7092. EMERGENCY DEPARTMENT ALTERNATIVES TO OPIOIDS DEMONSTRATION
PROGRAM.
(a) Demonstration Program Grants.--The Secretary of Health and
Human Services (in this section referred to as the ``Secretary'') shall
carry out a demonstration program under which the Secretary shall award
grants to hospitals and emergency departments, including freestanding
emergency departments, to develop, implement, enhance, or study
alternative pain management protocols and treatments that limit the use
and prescription of opioids in emergency departments.
(b) Eligibility.--To be eligible to receive a grant under
subsection (a), 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.
(c) Geographic Diversity.--In awarding grants under this section,
the Secretary shall seek to ensure geographical diversity among grant
recipients.
(d) Use of Funds.--Grants under subsection (a) shall be used to--
(1) target common painful conditions, such as renal colic,
sciatica, headaches, musculoskeletal pain, and extremity
fractures;
(2) train providers and other hospital personnel on
protocols and the use of treatments that limit the use and
prescription of opioids in the emergency department; and
(3) provide alternatives to opioids to patients with
painful conditions, not including patients who present with
pain related to cancer, end-of-life symptom palliation, or
complex multisystem trauma.
(e) Consultation.--The Secretary shall implement a process for
recipients of grants under subsection (a) to consult (in a manner that
allows for sharing of evidence-based best practices) with each other
and with persons having robust knowledge, including emergency
departments and physicians that have successfully deployed alternative
pain management protocols, such as non-drug approaches studied through
the National Center for Complimentary and Integrative Health including
acupuncture that limit the use of opioids. The Secretary shall offer to
each recipient of a grant under subsection (a) technical support as
necessary.
(f) 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 State and Federal
statutes and regulations regarding disclosure of patient information--
(1) a description of and specific information about the
alternative pain management protocols employed;
(2) data on the alternative pain management protocols and
treatments employed, including--
(A) during a baseline period before the program
began, as defined by the Secretary;
(B) at various stages of the program, as determined
by the Secretary; and
(C) the conditions for which the alternative pain
management protocols and treatments were employed;
(3) the success of each specific alternative pain
management protocol;
(4) data on the opioid prescriptions written, including--
(A) during a baseline period before the program
began, as defined by the Secretary;
(B) at various stages of the program, as determined
by the Secretary; and
(C) the conditions for which the opioids were
prescribed;
(5) the demographic characteristics of patients who were
treated with an alternative pain management protocol, including
age, sex, race, ethnicity, and insurance status and type;
(6) data on patients who were eventually prescribed opioids
after alternative pain management protocols and treatments were
employed; and
(7) any other information the Secretary deems necessary.
(g) 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 (f),
including standardized data; and
(3) recommendations for broader implementation of pain
management protocols that limit the use and prescription of
opioids in emergency departments or other areas of the health
care delivery system.
(h) 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--Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now
SEC. 7101. SHORT TITLE.
This subtitle may be cited as the ``Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act'' or the ``SCREEN Act''.
SEC. 7102. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED FOR
IMPORTATION.
(a) Increasing the Maximum Dollar Amount of Drugs Subject to
Destruction.--The sixth sentence in section 801(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking
``except that the Secretary'' and all that follows through the two
periods at the end and inserting ``except that the Secretary of Health
and Human Services may destroy, without the opportunity for export, any
drug refused admission under this section, if such drug is declared to
be valued at an amount that is $2,500 or less (or such higher amount as
the Secretary of the Treasury may set by regulation pursuant to section
498(a)(1) of the Tariff Act of 1930 or such higher amount as the
Commissioner of Food and Drugs may set based on a finding by the
Commissioner that the higher amount is in the interest of public
health), or if such drug is entering the United States by mail, and was
not brought into compliance as described under subsection (b).''.
(b) Destruction of Articles of Concern.--The sixth sentence of
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)), as amended by subsection (a), is further amended by inserting
before the period at the end the following: ``; and the Secretary of
Health and Human Services may destroy, without the opportunity for
export, any article refused admission under clause (6) of the third
sentence of this subsection''.
(c) Technical Amendments.--The seventh, eighth, and ninth sentences
of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(a)) are amended--
(1) by striking ``a drug'' each place it appears and
inserting ``an article''; and
(2) by striking ``the drug'' each place it appears and
inserting ``the article''.
(d) Rule of Construction.--The last sentence in section 801(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended
to read as follows: ``Clauses (2), (5), and (6) of the third sentence
of this subsection shall not be construed to prohibit the admission of
narcotic or nonnarcotic drugs or other substances, the importation of
which is permitted under the Controlled Substances Import and Export
Act.''.
SEC. 7103. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED DRUG PRODUCTS.
(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 Adulterated or
Misbranded Drugs.--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 ADULTERATED
OR MISBRANDED DRUGS.
``(a) Order To Cease Distribution and Recall.--
``(1) In general.--Upon a determination that the use or
consumption of, or exposure to, a drug may present an imminent
or substantial hazard to the public health, the Secretary shall
issue an order requiring any person who distributes the drug to
immediately cease distribution of the drug.
``(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--
``(A) the actions required by the order; and
``(B) whether the order should be amended to
require a recall of the drug.
``(3) Inadequate grounds.--If, after providing an
opportunity for a hearing under paragraph (2), the Secretary
determines that inadequate grounds exist to support the actions
required by the order, the Secretary shall vacate the order.
``(4) Amendment to order to require recall.--If, after
providing an opportunity for an informal hearing under
paragraph (2), the Secretary determines that the order should
be amended to include a recall of the drug with respect to
which the order was issued, the Secretary shall--
``(A) amend the order to require a recall; and
``(B) after consultation with the drug sponsor,
specify a timetable in which the recall will occur.
``(5) Notice to persons affected.--An order under this
subsection shall require any person who distributes the drug to
provide for notice, including to individuals as appropriate, to
persons who may be affected by the order to cease distribution
of or recall the drug, as applicable.
``(6) Action following order.--Any person who is subject to
an order under paragraph (1) or (4) shall immediately cease
distribution of or recall, as applicable, the drug and provide
notification as required by such order.
``(b) Notice to Consumers and Health Officials.--The Secretary
shall, as the Secretary determines to be necessary, provide notice of a
recall order under this section to--
``(1) consumers to whom the drug was, or may have been,
distributed; and
``(2) appropriate State and local health officials.
``(c) Order To Recall.--
``(1) Contents.--An order to recall a drug under subsection
(a) shall--
``(A) require periodic reports to the Secretary
describing the progress of the recall; and
``(B) provide for notice, including to individuals
as appropriate, to persons who may be affected by the
recall.
``(2) Assistance allowed.--In providing for notice under
paragraph (1)(B), the Secretary may allow for the assistance of
health professionals, State or local officials, or other
individuals designated by the Secretary.
``(3) Nondelegation.--An order under this section 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, is an official senior to such
Director, or is so designated by 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, an 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) Drugs Subject to Refusal.--The third sentence of subsection (a)
of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381) is amended by inserting ``or (5) in the case of a drug, such drug
is subject to an order under section 568 to cease distribution of or
recall the drug,'' before ``then such article shall be refused
admission''.
(d) Application.--Sections 301(eee) and 569D of the Federal Food,
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall
apply with respect to a drug as of such date, not later than 1 year
after the date of the enactment of this Act, as the Secretary of Health
and Human Services shall specify.
SEC. 7104. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADULTERATED OR
MISBRANDED DRUGS.
Section 801 of the Federal Food, Drug, and Cosmetic Act is amended
by adding at the end the following:
``(t) Single Source Pattern of Shipments of Adulterated or
Misbranded Drugs.--If the Secretary identifies a pattern of adulterated
or misbranded drugs being offered for import from the same
manufacturer, distributor, or importer, the Secretary may by order
choose to treat all drugs being offered for import from such
manufacturer, distributor, or importer as adulterated or misbranded
unless otherwise demonstrated.''.
SEC. 7105. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE OPIOID AND
SUBSTANCE USE EPIDEMIC.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE OPIOID AND
SUBSTANCE USE EPIDEMIC.
``(a) In General.--The Commissioner of Food and Drugs shall use any
funds appropriated pursuant to the authorization of appropriations
under subsection (c) to carry out the programs and activities described
in subsection (d) to strengthen and facilitate the Food and Drug
Administration's efforts to address the opioid and substance use
epidemic. Such funds shall be in addition to any funds which are
otherwise available to carry out such programs and activities.
``(b) FDA Opioid and Substance Use Epidemic Response Fund.--
``(1) Establishment of fund.--There is established in the
Treasury a fund, to be known as the FDA Opioid and Substance
Use Epidemic Response Fund (referred to in this subsection as
the `Fund'), for purposes of funding the programs and
activities described in subsection (d).
``(2) Transfer.--For the period of fiscal years 2019
through 2023, $110,000,000 shall be transferred to the Fund
from the general fund of the Treasury.
``(3) Amounts deposited.--Any amounts transferred under
paragraph (2) shall remain unavailable in the Fund until such
amounts are appropriated pursuant to subsection (c).
``(c) Appropriations.--
``(1) Authorization of appropriations.--For the period of
fiscal years 2019 through 2023, there is authorized to be
appropriated from the Fund to the Food and Drug Administration,
for the purpose of carrying out the programs and activities
described in subsection (d), an amount not to exceed the total
amount transferred to the Fund under subsection (b)(2).
Notwithstanding subsection (g), such funds shall remain
available until expended.
``(2) Offsetting future appropriations.--For any of fiscal
years 2019 through 2023, for any discretionary appropriation
out of the Fund to the Food and Drug Administration pursuant to
the authorization of appropriations under paragraph (1) for the
purpose of carrying out the programs and activities described
in subsection (d), the total amount of such appropriations for
the applicable fiscal year (not to exceed the total amount
remaining in the Fund) shall be subtracted from the estimate of
discretionary budget authority and the resulting outlays for
any estimate under the Congressional Budget and Impoundment
Control Act of 1974 or the Balanced Budget and Emergency
Deficit Control Act of 1985, and the amount transferred to the
Fund shall be reduced by the same amount.
``(d) Food and Drug Administration.--The entirety of the funds made
available pursuant to subsection (c)(1) shall be for the Commissioner
of Food and Drugs, pursuant to applicable authorities in the Public
Health Service Act (42 U.S.C. 201 et seq.) or this Act and other
applicable Federal law, to support widespread innovation in non-opioid
and non-addictive medical products for pain treatment, access to opioid
addiction treatments, appropriate use of approved opioids, and efforts
to reduce illicit importation of opioids. Such support may include the
following programs and activities:
``(1) Obligating contract funds beginning in fiscal year
2019 for an educational campaign that will--
``(A) educate patients and their families to
differentiate opioid medications;
``(B) raise awareness about preferred storage and
disposal methods; and
``(C) inform patients, families, and communities
about medication-assisted treatment options.
``(2) Building the Food and Drug Administration's presence
in international mail facilities, including through--
``(A) improvements in equipment and information
technology enhancements to identify unapproved,
counterfeit, or other unlawful pharmaceuticals for
destruction;
``(B) increased and improved surveillance;
``(C) renovations at international mail facility
locations; and
``(D) the purchase of laboratory equipment.
``(3) Enhancing the identification and targeting of
entities offering products and products being offered by such
entities for import into the United States through review and
analysis of Internet websites, import data, and other sources
of intelligence for purposes of making the best use of the Food
and Drug Administration's inspection and analytical resources.
``(4) Increasing the number of staff of the Food and Drug
Administration to increase the number of packages being
examined, ensuring the safety of the staff undertaking such
examinations, and ensuring that packages identified as illegal,
counterfeit, misbranded, or adulterated are removed from
commerce through available authorities, including
administrative destruction.
``(5) Enhancing the Food and Drug Administration's criminal
investigations resources (including full-time equivalent
employees and equipment), imports surveillance, and
international work.
``(6) Obtaining for the Food and Drug Administration
equipment and full-time equivalent employees needed to
efficiently screen and analyze products offered for import,
including by building data libraries of new substances and
analogues to facilitate identification and evaluation of
pharmaceutical-based agents and by purchasing screening
technologies for use at international mail facilities.
``(7) Operating the Food and Drug Administration's forensic
laboratory facility to ensure adequate laboratory space and
functionality for additional work and full-time equivalent
employees.
``(e) Accountability and Oversight.--
``(1) Work plan.--
``(A) In general.--Not later than 180 days after
the date of enactment of this Act, the Commissioner of
Food and Drugs 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 work plan including the proposed
allocation of funds appropriated pursuant to the
authorization of appropriations under subsection (c)
for each of fiscal years 2019 through 2023 and the
contents described in subparagraph (B).
``(B) Contents.--The work plan submitted under
subparagraph (A) shall include--
``(i) the amount of money to be obligated
or expended out of the Fund in each fiscal year
for each program and activity described in
subsection (d); and
``(ii) a description and justification of
each such program and activity.
``(2) Reports.--
``(A) Annual reports.--Not later than October 1 of
each of fiscal years 2020 through 2024, the Secretary
of Health and Human Services 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 that includes--
``(i) the amount of money obligated or
expended out of the Fund in the prior fiscal
year for each program and activity described in
subsection (d);
``(ii) a description of all programs and
activities using funds provided pursuant to the
authorization of appropriations under
subsection (c); and
``(iii) how the programs and activities are
advancing public health.
``(B) Additional reports.--At the request of the
Committee on Health, Education, Labor and Pensions of
the Senate or the Committee on Energy and Commerce of
the House of Representatives, the Commissioner shall
provide an update in the form of testimony and any
additional reports to the respective congressional
committee regarding the allocation of funding under
this section or the description of the programs and
activities undertaken with such funding.
``(f) Limitations.--Notwithstanding any transfer authority
authorized by this section or any appropriations Act, any funds made
available pursuant to the authorization of appropriations under
subsection (c) may not be used for any purpose other than the programs
and activities described in subsection (d) to strengthen and facilitate
the Food and Drug Administration's efforts to address the opioid and
substance use epidemic.
``(g) Sunset.--This section shall expire on September 30, 2022,
except that--
``(1) this subsection does not apply to reporting under
subsection (e)(2); and
``(2) this section shall remain in effect until such time,
and to such extent, as may be necessary for the funds
transferred by subsection (b)(2) to be fully expended.''.
SEC. 7106. CONSIDERATION OF POTENTIAL FOR MISUSE AND ABUSE REQUIRED FOR
DRUG APPROVAL.
(a) In General.--Section 505(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(d)) is amended--
(1) in the first sentence--
(A) by striking ``or (7)'' and inserting ``(7)'';
and
(B) by inserting ``or (8) if the drug is or
contains a controlled substance for which a listing in
any schedule is in effect under the Controlled
Substances Act or that is permanently scheduled
pursuant to section 201 of such Act, on the basis of
information submitted to him as part of the
application, or upon the basis of any other information
before him with respect to such drug, the drug is
unsafe for use due to the risks of abuse or misuse or
there is insufficient information to show that the drug
is safe for use considering such risks;'' before ``he
shall issue an order refusing to approve the
application''; and
(2) in the second sentence, by striking ``(6)'' and
inserting ``(8)''.
(b) Withdrawal Authority.--Section 505(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended in the first
sentence--
(1) by striking ``or (5)'' and inserting ``(5)''; and
(2) by inserting the following: ``; or (6) that, in the
case of a drug that is or contains a controlled substance for
which a listing in any schedule is in effect under the
Controlled Substances Act or that is permanently scheduled
pursuant to section 201 of such Act, on the basis of new
information before him with respect to such drug, evaluated
together with the information available to him when the
application was approved, that the drug is unsafe for use due
to the risks of abuse or misuse'' after ``of a material fact''.
(c) Rule of Construction.--Nothing in the amendments made by this
section shall be construed to limit or narrow, in any manner, the
meaning or application of the provisions of paragraphs (1), (2), (3),
(4), (5), and (7) of section 505(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and (2) of section
505(e) of such Act (21 U.S.C. 355(e)).
Subtitle L--Treatment, Education, and Community Help to Combat
Addiction
SEC. 7111. SHORT TITLE.
This subtitle may be cited as the ``Treatment, Education, and
Community Help to Combat Addiction Act of 2018'' or the ``TEACH to
Combat Addiction Act of 2018''.
SEC. 7112. ESTABLISHMENT OF REGIONAL CENTERS OF EXCELLENCE IN SUBSTANCE
USE DISORDER EDUCATION.
Part D of title V of the Public Health Service Act is amended by
inserting after section 549 (42 U.S.C. 290ee-4) the following new
section:
``SEC. 550. REGIONAL CENTERS OF EXCELLENCE IN SUBSTANCE USE DISORDER
EDUCATION.
``(a) In General.--The Secretary, in consultation with such other
agencies as are appropriate, shall, subject to the availability of
appropriations, establish a solicitation process and award cooperative
agreements to eligible entities for the designation of such entities as
Regional Centers of Excellence in Substance Use Disorder Education and
support of such regional centers of excellence to enhance and improve
how health professionals are educated in substance use disorder
prevention, treatment, and recovery through development, evaluation,
and distribution of evidence-based curricula for health profession
schools. An eligible entity designated by the Secretary as a Regional
Center of Excellence in Substance Use Disorder Education shall carry
out the activities described in subsection (b).
``(b) Selection of Centers of Excellence.--
``(1) Eligible entities.--To be eligible to receive a
cooperative agreement under subsection (a), an entity shall--
``(A) be an entity specified by the Secretary that
offers education to students in various health
professions, which may include--
``(i) a health system;
``(ii) a teaching hospital;
``(iii) a medical school;
``(iv) a certified behavioral health
clinic; or
``(v) any other health profession school,
school of public health, or Cooperative
Extension Program at institutions of higher
education engaged in an aspect of the
prevention, treatment, or recovery of substance
use disorders;
``(B) be accredited by the appropriate educational
accreditation body;
``(C) demonstrate an existing strategy, and have in
place a plan for continuing such strategy, or a
proposed strategy to implement a curriculum based on
best practices for substance use disorder prevention,
treatment, and recovery;
``(D) demonstrate community engagement and
participation through community partners, including
other health profession schools, mental health
counselors, social workers, peer recovery specialists,
substance use treatment programs, community health
centers, physicians' offices, certified behavioral
health clinics, law enforcement, and the business
community; and
``(E) provide to the Secretary such information, at
such time, and in such manner, as the Secretary may
require.
``(2) Diversity.--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 diversity.
``(c) Dissemination of Information.--
``(1) Public posting.--The Secretary shall make information
provided to the Secretary under subsection (b)(1)(E) publically
available on the Internet website of the Department of Health
and Human Services.
``(2) Evaluation.--The Secretary shall evaluate each
project carried out by a Regional Center of Excellence in
Substance Use Disorder Education under this section and shall
disseminate the findings with respect to each such evaluation
to appropriate public and private entities.
``(d) Funding.--There is authorized to be appropriated to carry out
this section, $4,000,000 for each of fiscal years 2019 through 2023.''.
Subtitle M--Guidance From National Mental Health and Substance Use
Policy Laboratory
SEC. 7121. GUIDANCE 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), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(7) issue and periodically update guidance for entities
applying for grants from the Substance Abuse and Mental Health
Services Administration in order to--
``(A) encourage the funding of evidence-based
practices;
``(B) encourage the replication of promising or
effective practices; and
``(C) inform applicants on how to best articulate
the rationale for the funding of a program or
activity.''.
Subtitle N--Comprehensive Opioid Recovery Centers
SEC. 7131. SHORT TITLE.
This subtitle may be cited as the ``Comprehensive Opioid Recovery
Centers Act of 2018''.
SEC. 7132. COMPREHENSIVE OPIOID RECOVERY CENTERS.
(a) In General.--Part D of title V of the Public Health Service Act
is amended by adding at the end the following new section:
``SEC. 550. 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').
``(b) Grant Period.--
``(1) In general.--A grant awarded under subsection (a)
shall be for a period 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 (i) in such amounts that not
fewer than 10 Centers will be established across the United States.
``(d) 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--
``(1) evidence that such entity carries out, or is capable
of coordinating with other entities to carry out, the
activities described in subsection (g); and
``(2) such other information as the Secretary may require.
``(e) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to eligible entities located in a State
or Indian country (as defined in section 1151 of title 18, United
States Code)--
``(1) with a high per capita drug overdose mortality rate,
as determined by the Director of the Centers for Disease
Control and Prevention; or
``(2) based on any other criteria or need, as determined by
the Secretary.
``(f) Use of Grant Funds.--An eligible entity awarded a grant under
subsection (a) shall use the grant funds to establish or operate a
Center to carry out the activities described in subsection (g).
``(g) Center Activities and Services.--Each Center shall, at a
minimum, carry out the activities described in this subsection. In the
case of a Center that determines that a service described in paragraph
(2) cannot reasonably be carried out by the Center, such Center shall
contract with such other entities as may be necessary to ensure that
patients have access to the full range of services described in such
paragraph.
``(1) Community outreach.--Each Center shall carry out the
following outreach activities:
``(A) Train and supervise outreach staff to work
with schools, workplaces, faith-based organizations,
State and local health departments, law enforcement,
and first responders to ensure that such institutions
are aware of the services of the Center.
``(B) Disseminate and make available online
evidence-based resources that educate professionals and
the public on opioid use disorder and other substance
use disorders.
``(2) Treatment and recovery services.--Each Center shall
provide the following treatment and recovery services:
``(A) Ensure that intake evaluations meet the
clinical needs of patients.
``(B) Periodically conduct patient assessments to
ensure continued and meaningful recovery, as defined by
the Assistant Secretary for Mental Health and Substance
Use.
``(C) Provide the full continuum of treatment
services, including--
``(i) all drugs approved under section 505
of the Federal Food, Drug, and Cosmetic Act and
all biological products licensed under section
351 of this Act, including methadone, to treat
substance use disorders, including opioid use
disorder and alcohol use disorder;
``(ii) withdrawal management, which shall
include medically supervised detoxification
that includes patient evaluation,
stabilization, and readiness for and entry into
treatment;
``(iii) counseling and case management,
including counseling and recovery services for
any possible co-occurring mental illness;
``(iv) residential rehabilitation;
``(v) recovery housing;
``(vi) community-based and peer recovery
support services;
``(vii) job training and placement
assistance to support reintegration into the
workforce; and
``(viii) other best practices, as
determined by the Secretary.
``(D) Administer an onsite pharmacy and provide
toxicology services.
``(E) Establish and operate a secure and
confidential electronic health information system.
``(F) Offer family support services such as child
care, family counseling, and parenting interventions to
help stabilize families impacted by substance use
disorder.
``(h) Data Reporting and Program Oversight.--With respect to a
grant awarded under subsection (a) to an eligible entity for a Center,
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 individuals with a substance use
disorder who received services from the Center;
``(3) the effectiveness of interventions designed, tested,
and evaluated by the Center; and
``(4) any other information that the Secretary may require
for the purpose of--
``(A) evaluating the effectiveness of the Center;
and
``(B) ensuring that the Center is complying with
all the requirements of the grant, including providing
the full continuum of services described in subsection
(g)(2)(C) and providing drugs and devices for overdose
reversal under such subsection.
``(i) 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 550(h) of the Public
Health Service Act, as added by subsection (a).
(2) Final report.--Not later than 1 year 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
comprehensive opioid recovery centers established or
operated pursuant to section 550 of the Public Health
Service Act, as added by subsection (a);
(B) recommendations on whether the grant program
established under such section 550 should be
reauthorized and expanded; and
(C) standards and best practices for the treatment
of substance use disorders, as identified through such
grant program.
Subtitle O--Poison Center Network Enhancement
SEC. 7141. SHORT TITLE.
This subtitle may be cited as the ``Poison Center Network
Enhancement Act of 2018''.
SEC. 7142. REAUTHORIZATION OF POISON CONTROL CENTERS NATIONAL TOLL-FREE
NUMBER.
Section 1271 of the Public Health Service Act (42 U.S.C. 300d-71)
is amended to read as follows:
``SEC. 1271. ESTABLISHMENT AND MAINTENANCE OF THE NATIONAL TOLL-FREE
NUMBER AND ENHANCED COMMUNICATIONS CAPABILITIES.
``(a) In General.--The Secretary shall provide coordination and
assistance to poison control centers for--
``(1) the development, establishment, implementation, and
maintenance of a nationwide toll-free phone number; and
``(2) the enhancement of communications capabilities, which
may include text capabilities.
``(b) Consultation.--The Secretary may consult with nationally
recognized professional organizations in the field of poison control to
determine the best and most effective means of achieving the goals
described in paragraphs (1) and (2) of subsection (a).
``(c) Rule of Construction.--In assisting with public health
emergencies, responses, or preparedness, nothing in this section shall
be construed to restrict the work of poison control centers or the use
of their resources by the Secretary or other governmental agencies.
``(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $700,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7143. REAUTHORIZATION OF NATIONWIDE PUBLIC AWARENESS CAMPAIGN TO
PROMOTE POISON CONTROL CENTER UTILIZATION.
Section 1272 of the Public Health Service Act (42 U.S.C. 300d-72)
is amended to read as follows:
``SEC. 1272. NATIONWIDE PUBLIC AWARENESS CAMPAIGN TO PROMOTE POISON
CONTROL CENTER UTILIZATION AND THEIR PUBLIC HEALTH
EMERGENCY RESPONSE CAPABILITIES.
``(a) In General.--The Secretary shall--
``(1) carry out, and expand upon, a national public
awareness campaign to educate the public and health care
providers about--
``(A) poisoning, toxic exposure, and drug misuse
prevention; and
``(B) the availability of poison control center
resources in local communities; and
``(2) as part of such campaign, highlight the nationwide
toll-free number and enhanced communications capabilities
supported under section 1271.
``(b) Consultation.--In carrying out and expanding upon the
national campaign under subsection (a), the Secretary may consult with
nationally recognized professional organizations in the field of poison
control response for the purpose of determining the best and most
effective methods for achieving public awareness.
``(c) Contract With Entity.--The Secretary may carry out subsection
(a) by entering into contracts with one or more public or private
entities, including nationally recognized professional organizations in
the field of poison control and national media firms, for the
development and implementation of the awareness campaign under
subsection (a), which may include--
``(1) the development and distribution of poisoning and
toxic exposure prevention, poison control center, and public
health emergency awareness and response materials;
``(2) television, radio, internet, and newspaper public
service announcements; and
``(3) other means and activities to provide for public and
professional awareness and education.
``(d) Evaluation.--The Secretary shall--
``(1) establish baseline measures and benchmarks to
quantitatively evaluate the impact of the nationwide public
awareness campaign carried out under this section; and
``(2) on a biennial basis, prepare and submit to the
appropriate committees of Congress an evaluation of the
nationwide public awareness campaign.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $800,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7144. REAUTHORIZATION OF THE POISON CONTROL CENTER GRANT PROGRAM.
Section 1273 of the Public Health Service Act (42 U.S.C. 300d-73)
is amended to read as follows:
``SEC. 1273. MAINTENANCE OF THE POISON CONTROL CENTER GRANT PROGRAM.
``(a) Authorization of Program.--The Secretary shall award grants
to poison control centers accredited under subsection (c) (or granted a
waiver under subsection (d)) and nationally recognized professional
organizations in the field of poison control for the purposes of--
``(1) preventing, and providing treatment recommendations
for, poisonings and toxic exposures including opioid and drug
misuse;
``(2) assisting with public health emergencies, responses,
and preparedness; and
``(3) complying with the operational requirements needed to
sustain the accreditation of the center under subsection (c).
``(b) Additional Uses of Funds.--In addition to the purposes
described in subsection (a), a poison center or professional
organization awarded a grant under such subsection may also use amounts
received under such grant--
``(1) to research, establish, implement, and evaluate best
practices in the United States for poisoning prevention, poison
control center outreach, opioid and drug misuse information and
response, and public health emergency, response, and
preparedness programs;
``(2) to research, develop, implement, revise, and
communicate standard patient management guidelines for commonly
encountered toxic exposures;
``(3) to improve national toxic exposure and opioid misuse
surveillance by enhancing cooperative activities between poison
control centers in the United States and the Centers for
Disease Control and Prevention and other governmental agencies;
``(4) to research, improve, and enhance the communications
and response capability and capacity of the Nation's network of
poison control centers to facilitate increased access to the
centers through the integration and modernization of the
current poison control centers communications and data system,
including enhancing the network's telephony, internet, data,
and social networking technologies;
``(5) to develop, support, and enhance technology and
capabilities of nationally recognized professional
organizations in the field of poison control to collect
national poisoning, toxic occurrence, and related public health
data;
``(6) to develop initiatives to foster the enhanced public
health utilization of national poison data collected by such
organizations;
``(7) to support and expand the toxicologic expertise
within poison control centers; and
``(8) to improve the capacity of poison control centers to
answer high volumes of contacts and internet communications,
and to sustain and enhance the poison control center's network
capability to respond during times of national crisis or other
public health emergencies.
``(c) Accreditation.--Except as provided in subsection (d), the
Secretary may award a grant to a poison control center under subsection
(a) only if--
``(1) the center has been accredited by a nationally
recognized professional organization in the field of poison
control, and the Secretary has approved the organization as
having in effect standards for accreditation that reasonably
provide for the protection of the public health with respect to
poisoning; or
``(2) the center has been accredited by a State government,
and the Secretary has approved the State government as having
in effect standards for accreditation that reasonably provide
for the protection of the public health with respect to
poisoning.
``(d) Waiver of Accreditation Requirements.--
``(1) In general.--The Secretary may grant a waiver of the
accreditation requirements of subsection (c) with respect to a
nonaccredited poison control center that applies for a grant
under this section if such center can reasonably demonstrate
that the center will obtain such an accreditation within a
reasonable period of time as determined appropriate by the
Secretary.
``(2) Renewal.--The Secretary may renew a waiver under
paragraph (1).
``(3) Limitation.--The Secretary may not, after the date of
enactment of the Poison Control Network Enhancement Act of
2018, grant to a poison control center waivers or renewals that
total more than 5 years.
``(e) Supplement Not Supplant.--Amounts made available to a poison
control center under this section shall be used to supplement and not
supplant other Federal, State, or local funds provided for such center.
``(f) Maintenance of Effort.--A poison control center, in utilizing
the proceeds of a grant under this section, shall maintain the annual
recurring expenditures of the center for its activities at a level that
is not less than 80 percent of the average level of such recurring
expenditures maintained by the center for the preceding 3 fiscal years
for which a grant is received.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $28,600,000 for each of fiscal
years 2019 through 2023. The Secretary may utilize an amount not to
exceed 6 percent of the amount appropriated pursuant to the preceding
sentence for each fiscal year for coordination, dissemination,
technical assistance, program evaluation, data activities, and other
program administration functions, which are determined by the Secretary
to be appropriate for carrying out the program under this section.''.
Subtitle P--Eliminating Opioid Related Infectious Diseases
SEC. 7151. SHORT TITLE.
This subtitle may be cited as the ``Eliminating Opioid Related
Infectious Diseases Act of 2018''.
SEC. 7152. 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 may (directly and through grants
to public and nonprofit private entities) provide for programs for the
following:
``(1) To cooperate with the States and Indian tribes in
implementing or maintaining a surveillance system to determine
the incidence of infections commonly associated with illicit
drug use, including infections commonly associated with
injection 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 as a result of
injection 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
and the coordination of treatment of addiction and infectious
diseases described in paragraph (1), with priority given to
substance use disorder treatment providers, pediatricians and
other primary care providers, obstetrician-gynecologists,
infectious diseases clinicians, and 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) Definitions.--In this section:
``(1) The term `Indian tribe' has the meaning given that
term in section 4 of the Indian Self-Determination and
Education Assistance Act.
``(2) The term `injection drug use' means--
``(A) intravenous administration of a substance in
schedule I under section 202 of the Controlled
Substances Act;
``(B) intravenous administration of a substance in
schedule II, III, IV, or V under section 202 of the
Controlled Substances Act that has not been approved
for intravenous use under--
``(i) section 505 of the Federal Food, Drug
and Cosmetic Act; or
``(ii) section 351 of the Public Health
Service Act; or
``(C) intravenous administration of a substance in
schedule II, III, IV, or V under section 202 of the
Controlled Substances Act that has not been prescribed
to the person using the substance.
``(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 Q--Better Pain Management Through Better Data
SEC. 7161. SHORT TITLE.
This subtitle may be cited as the ``Better Pain Management Through
Better Data Act of 2018''.
SEC. 7162. GUIDANCE ADDRESSING ALTERNATIVE APPROACHES TO DATA
COLLECTION AND LABELING CLAIMS FOR OPIOID SPARING.
(a) In General.--For purposes of assisting sponsors in collecting
and incorporating opioid-sparing data in product labeling, the
Secretary of Health and Human Services (referred to in this section as
the ``Secretary'') shall conduct a public meeting and update or issue
one or more guidances in accordance with subsection (b).
(b) Guidance.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall update or issue one or more guidances addressing--
(A) alternative methods for data collection on
opioid sparing;
(B) alternative methods for inclusion of such data
in product labeling; and
(C) investigations other than clinical trials,
including partially controlled studies and objective
trials without matched controls such as historically
controlled analyses, open-label studies, and meta-
analyses, on opioid sparing for inclusion in product
labeling.
(2) Contents.--The guidances under paragraph (1) shall
address--
(A) innovative clinical trial designs for ethically
and efficiently collecting data on opioid sparing for
inclusion in product labeling;
(B) primary and secondary endpoints for the
reduction of opioid use while maintaining adequate pain
control;
(C) use of real world evidence, including patient
registries, and patient reported outcomes to support
inclusion of opioid-sparing data in product labeling;
and
(D) how sponsors may obtain feedback from the
Secretary relating to such issues prior to--
(i) commencement of such data collection;
or
(ii) the submission of resulting data to
the Secretary.
(3) Public meeting.--Prior to updating or issuing the
guidances required by paragraph (1), the Secretary shall
consult with stakeholders, including representatives of
regulated industry, academia, patients, and provider
organizations, through a public meeting to be held not later
than 12 months after the date of enactment of this Act.
(4) Timing.--The Secretary shall--
(A) not later than 12 months after the date of the
public meeting required by paragraph (3), update or
issue the one or more draft guidances required by
paragraph (1); and
(B) not later than 12 months after the date on
which the public comment period for such draft
guidances closes, finalize such guidances.
(c) Definition.--In this section:
(1) The terms ``opioid sparing'' and ``opioid-sparing''
refer to the use of drugs or devices (as defined in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321))
that reduce pain while enabling the reduction, replacement, or
avoidance of oral opioids.
(2) The term ``Secretary'' means the Secretary of Health
and Human Services.
Subtitle R--Special Registration for Telemedicine Clarification
SEC. 7171. SHORT TITLE.
This subtitle may be cited as the ``Special Registration for
Telemedicine Clarification Act of 2018''.
SEC. 7172. DEADLINE FOR INTERIM FINAL REGULATIONS FOR A SPECIAL
REGISTRATION TO ENGAGE IN THE PRACTICE OF TELEMEDICINE.
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C.
831(h)(2)) is amended by striking ``The Attorney General shall, with
the concurrence of the Secretary, promulgate regulations'' and
inserting ``Not later than 1 year after the date of enactment of the
Special Registration for Telemedicine Clarification Act of 2018, the
Attorney General shall, with the concurrence of the Secretary,
promulgate interim final regulations''.
Subtitle S--Peer Support Communities of Recovery
SEC. 7181. SHORT TITLE.
This subtitle may be cited as the ``Peer Support Communities of
Recovery Act''.
SEC. 7182. BUILDING COMMUNITIES OF RECOVERY.
Section 547 of the Public Health Service Act (42 U.S.C. 290ee-2) is
amended--
(1) in subsection (a)--
(A) in the heading, by striking ``Definition'' and
inserting ``Definitions'';
(B) in the matter preceding paragraph (1), by
striking ``In this section, the term `recovery
community organization' means an independent nonprofit
organization that--'' and inserting ``In this
section:'';
(C) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving
such subparagraphs (as so redesignated) 2 ems to the
right;
(D) by inserting before subparagraph (A) (as so
redesignated) the following:
``(1) Recovery community organization.--The term `recovery
community organization' means an independent nonprofit
organization that--''; and
(E) by adding at the end the following:
``(2) Eligible entity.--The term `eligible entity' means--
``(A) a national nonprofit entity focused on
substance use disorder with a network of local
affiliates and partners that are geographically and
organizationally diverse; or
``(B) a nonprofit organization--
``(i) focused on substance use disorder;
``(ii) established by individuals in
personal or family recovery; and
``(iii) serving prevention, treatment,
recovery, payor, faith-based, and criminal
justice stakeholders in the implementation of
local addiction and recovery initiatives.'';
(2) in subsection (b)--
(A) by striking ``The Secretary shall award grants
to recovery community organizations'' and inserting
``The Secretary--
``(1) shall award grants to recovery community
organizations'';
(B) by striking ``services.'' and inserting
``services and allow such organizations to use such
grant funds to carry out the activities described in
subparagraphs (A) through (C) of subsection (c)(2);
and''; and
(C) by adding at the end the following:
``(2) may award grants to eligible entities for purposes of
establishing regional technical assistance centers, in
accordance with subsection (c)(2)(D).'';
(3) by striking subsection (c);
(4) by redesignating subsections (d) and (e) as subsections
(c) and (d), respectively;
(5) in subsection (c) (as so redesignated)--
(A) in paragraph (1), by striking ``shall be used''
and inserting ``to a recovery community organization
shall be used'';
(B) in paragraph (2)--
(i) in subparagraph (A), in the matter
preceding clause (i), by inserting before
``build'' the following: ``in the case of a
grant awarded to a recovery community
organization,'';
(ii) in subparagraph (B)--
(I) by inserting before ``reduce''
the following: ``in the case of a grant
awarded to a recovery community
organization,''; and
(II) by striking ``and'' at the
end;
(iii) in subparagraph (C)--
(I) by inserting before ``conduct''
the following: ``in the case of a grant
awarded to a recovery community
organization,''; and
(II) by striking the period at the
end and inserting ``; and''; and
(iv) by adding at the end the following:
``(D) in the case of a grant awarded to an eligible
entity, provide for the establishment of regional
technical assistance centers to provide regional
technical assistance for the following:
``(i) Implementation of regionally driven,
peer-delivered addiction recovery support
services before, during, after, or in
conjunction with addiction treatment.
``(ii) Establishment of recovery community
organizations.
``(iii) Establishment of recovery community
centers.''; and
(6) in subsection (d) (as so redesignated), by inserting
before the period the following: ``, and $15,000,000 for each
of fiscal years 2019 through 2023''.
Subtitle T--Stop Illicit Drug Importation
SEC. 7191. SHORT TITLE.
This short title may be cited as the ``Stop Illicit Drug
Importation Act of 2018''.
SEC. 7192. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED FOR
IMPORTATION.
(a) Articles Treated as Drugs for Purposes of Importation.--Section
801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is
amended by adding at the end the following:
``(t) Articles Treated as Drugs for Purposes of This Section.--
``(1) Labeled articles.--An article shall not be treated as
a drug pursuant to this subsection if--
``(A) an electronic import entry for such article
is submitted using an authorized electronic data
interchange system; and
``(B) such article is designated in such system as
a drug, device, dietary supplement, or other product
that is regulated under this Act.
``(2) Articles covered.--Subject to paragraph (1), for
purposes of this section, an article described in this
paragraph may be treated by the Secretary as a drug if it--
``(A) is or contains an ingredient that is an
active ingredient that is contained within--
``(i) a drug that has been approved under
section 505 of this Act; or
``(ii) a biological product that has been
approved under section 351 of the Public Health
Service Act;
``(B) is or contains an ingredient that is an
active ingredient in a drug or biological product if--
``(i) an investigational use exemption has
been authorized for such drug or biological
product under section 505(i) of this Act or
section 351(a) of the Public Health Service
Act;
``(ii) substantial clinical investigation
has been instituted for such drug or biological
product; and
``(iii) the existence of such clinical
investigation has been made public; or
``(C) is or contains 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 subparagraph (A) or
(B).
``(3) Effect.--Except to the extent that an article may be
treated as a drug pursuant to paragraph (2), this subsection
shall not be construed as bearing on or being relevant to the
question of whether any article is a drug as defined in section
201(g).''.
(b) Articles of Concern.--
(1) Delivery by treasury to hhs.--The first sentence of
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(a)) is amended by striking ``and cosmetics'' and
inserting ``cosmetics, and potential articles of concern (as
defined in subsection (u))''.
(2) Refused admission.--The third sentence of section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended by striking ``then such article shall be
refused admission'' and inserting ``or (5) such article is an
article of concern (as defined in subsection (u)), or (6) such
article is a drug that is being imported or offered for import
in violation of section 301(cc), then such article shall be
refused admission''.
(3) Definition of article of concern.--Section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as
amended, is further amended by adding at the end the following:
``(u) Article of Concern Defined.--For purposes of subsection (a),
the term `article of concern' means an article that is or contains a
drug or other substance--
``(1) for which, during the 24-month period prior to the
article being imported or offered for import, the Secretary of
Health and Human Services--
``(A) has requested that, based on a determination
that the drug or other substance appears to meet the
requirements for temporary or permanent scheduling
pursuant to section 201 of the Controlled Substances
Act, the Attorney General initiate the process to
control the drug or other substance in accordance with
such Act; or
``(B) has, following the publication by the
Attorney General of a notice in the Federal Register of
the intention to issue an order temporarily scheduling
such drug or substance in schedule I of section 202 of
the Controlled Substances Act pursuant to section
201(h) of such Act, made a determination that such
article presents an imminent hazard to public safety;
and
``(2) with respect to which the Attorney General has not--
``(A) scheduled the drug or other substance under
such Act; or
``(B) notified the Secretary of Health and Human
Services that the Attorney General has made a
determination not to schedule the drug or other
substance under such Act.''.
SEC. 7193. SEIZURE.
Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 334(b)) is amended by striking the first sentence and inserting
the following: ``The article, equipment, or other thing proceeded
against shall be liable to seizure by process pursuant to the libel,
and the procedure in cases under this section shall conform, as nearly
as may be, to the procedure in admiralty rather than the procedure used
for civil asset forfeiture proceedings set forth in section 983 of
title 18, United States Code. On demand of either party any issue of
fact joined in any such a case brought under this section shall be
tried by jury. A seizure brought under this section is not governed by
Rule G of the Supplemental Rules of Admiralty or Maritime Claims and
Asset Forfeiture Actions. Exigent circumstances shall be deemed to
exist for all seizures brought under this section, and in such cases,
the summons and arrest warrant shall be issued by the clerk of the
court without court review.''.
SEC. 7194. DEBARRING VIOLATIVE INDIVIDUALS OR COMPANIES.
(a) Prohibited Act.--Section 301(cc) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(cc)) is amended--
(1) by inserting after ``an article of food'' the
following: ``or a drug''; and
(2) by inserting after ``a person debarred'' the following:
``from such activity''.
(b) Debarment.--Section 306(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
striking ``paragraph (2)'' and inserting ``paragraph
(2) or (3)'';
(B) in subparagraph (B), by striking ``or'' at the
end;
(C) in subparagraph (C), by striking the period at
the end and inserting ``, or''; and
(D) by adding at the end the following:
``(D) a person from importing or offering to import
into the United States--
``(i) a controlled substance as defined in
section 102(6) of the Controlled Substances
Act; or
``(ii) any drug, if such drug is declared
to be valued at an amount that is $2,500 or
less (or such higher amount as the Secretary of
the Treasury may set by regulation pursuant to
section 498(a)(1) of the Tariff Act of 1930),
or if such drug is entering the United States
by mail.''; and
(2) in paragraph (3)--
(A) in the paragraph heading after ``food'' by
inserting ``or drug'';
(B) by redesignating subparagraphs (A) and (B) as
clauses (i) and (ii), respectively, and moving the
indentation of each such clause 2 ems to the right;
(C) after making the amendments required by
subparagraph (B), by striking ``A person is subject''
and inserting the following:
``(A) Food.--A person is subject''; and
(D) by adding at the end the following:
``(B) Importation of drugs.--A person is subject to
debarment under paragraph (1)(D) if--
``(i) 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); or
``(ii) the person has engaged in a pattern
of importing or offering for import articles of
drug that are--
``(I)(aa) adulterated, misbranded,
or in violation of section 505; and
``(bb) present a threat of serious
adverse health consequences or death to
humans or animals; or
``(II) controlled substances whose
importation is prohibited pursuant to
section 401(m) of the Tariff Act of
1930.
``(C) Definition.--For purposes of subparagraph
(B), the term `pattern of importing or offering for
import articles of drug' means importing or offering
for import articles of drug described in subclause (I)
or (II) of subparagraph (B)(ii) in an amount,
frequency, or dosage that is inconsistent with personal
or household use by the importer.''.
Subtitle U--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
SEC. 7201. SHORT TITLE.
This subtitle may be cited as the ``Creating Opportunities that
Necessitate New and Enhanced Connections That Improve Opioid Navigation
Strategies Act of 2018'' or the ``CONNECTIONS Act''.
SEC. 7202. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following new
section:
``SEC. 399V-7. 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 any
evidence-based prevention activity described in
paragraph (2);
``(B) provide training and technical assistance to
States, localities, and Indian tribes for purposes of
carrying out any such activity; and
``(C) award grants to States, localities, and
Indian tribes for purposes of carrying out any such
activity.
``(2) Evidence-based prevention activities.--An evidence-
based prevention activity described in this paragraph is any of
the following activities:
``(A) With respect to a State, improving the
efficiency and use of the State prescription drug
monitoring program by--
``(i) encouraging all authorized users (as
specified by the State) to register with and
use the program and making the program easier
to use;
``(ii) enabling such users to access any
updates to information collected by the program
in as close to real-time as possible;
``(iii) providing for a mechanism for the
program to automatically flag any potential
misuse or abuse of controlled substances and
any detection of inappropriate prescribing
practices relating to such substances;
``(iv) enhancing interoperability between
the program and any electronic health records
system, including by integrating the use of
electronic health records into the program for
purposes of improving clinical decisionmaking;
``(v) continually updating program
capabilities to respond to technological
innovation for purposes of appropriately
addressing a controlled substance overdose
epidemic as such epidemic may occur and evolve;
``(vi) facilitating data sharing between
the program and the prescription drug
monitoring programs of neighboring States; and
``(vii) meeting the purpose of the program
established under section 399O, as described in
section 399O(a).
``(B) Achieving community or health system
interventions through activities such as--
``(i) establishing or improving controlled
substances prescribing interventions for
insurers and health systems;
``(ii) enhancing the use of evidence-based
controlled substances prescribing guidelines
across sectors and health care settings; and
``(iii) implementing strategies to align
the prescription of controlled substances with
the guidelines described in clause (ii).
``(C) Evaluating interventions to better understand
what works to prevent overdoses, including those
involving prescription and illicit controlled
substances.
``(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.
``(b) Enhanced Surveillance of Controlled Substance Overdose
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 surveillance activity
described in paragraph (2);
``(B) provide training and technical assistance to
States for purposes of carrying out any such activity;
``(C) award grants to States for purposes of
carrying out any 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 the emergency rooms
of hospitals as a result of the abuse of alcohol or
other drugs).
``(2) Controlled substance overdose surveillance
activities.--A controlled substance overdose surveillance
activity described in this paragraph is any of the following
activities:
``(A) Enhancing the timeliness of reporting data to
the public, including data on fatal and nonfatal
overdoses of controlled substances.
``(B) Enhancing comprehensiveness of data on
controlled substances overdoses by collecting
information on such overdoses from appropriate sources
such as toxicology reports, autopsy reports, death
scene investigations, and other risk factors.
``(C) Using data to help identify risk factors
associated with controlled substances overdoses.
``(D) With respect to a State, supporting entities
involved in providing information to inform efforts
within the State, such as by coroners and medical
examiners, to improve accurate testing and reporting of
causes and contributing factors to controlled
substances overdoses.
``(E) Working to enable information sharing
regarding controlled substances overdoses among data
sources.
``(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 and section 399O, there is authorized to be
appropriated $486,000,000 for each of fiscal years 2019 through
2023.''.
SEC. 7203. 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, in
consultation with the Director of National Drug Control Policy,
acting through the Director of the Centers for Disease Control
and Prevention, the Assistant Secretary for Mental Health and
Substance Use, and the National Coordinator for Health
Information Technology, shall support States 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, within a
State;
``(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 and access of PDMPs by
providers and their delegates, to the
extent that State laws allow;
``(ii) 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) 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) State legislation.--As a condition on the receipt of
support under this section, the Secretary shall require a State
to demonstrate that the State 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, in
establishing, improving, or maintaining a PDMP, to implement strategies
that improve--
``(1) the reporting of dispensing in the State 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 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; and
``(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.
``(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.
``(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 the CONNECTIONS Act, the Secretary shall--
``(1) complete a study that--
``(A) determines the progress of States in
establishing and implementing PDMPs consistent with
this section;
``(B) provides an analysis of the extent to which
the operation of PDMPs has--
``(i) reduced inappropriate use, abuse,
diversion of, and overdose with, controlled
substances;
``(ii) established or strengthened
initiatives to ensure linkages to substance use
disorder treatment services; or
``(iii) affected patient access to
appropriate care in States operating PDMPs;
``(C) determine the progress of States 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 States 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 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 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 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 may establish an advisory
council to assist in the establishment, improvement, or
maintenance of a PDMP consistent with this section.
``(2) Limitation.--A State 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
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 V--Securing Opioids and Unused Narcotics With Deliberate
Disposal and Packaging
SEC. 7211. SHORT TITLE.
This subtitle 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. 7212. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH RESPECT TO
THE PACKAGING OR DISPOSAL OF CERTAIN DRUGS.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 505-1 (21 U.S.C. 355-1) the
following new section:
``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.
``(a) Orders.--
``(1) In general.--The Secretary may issue an order
requiring the holder of a covered application to implement or
modify one or more technologies, controls, or measures with
respect to the packaging or disposal of one or more drugs
identified in the covered application, if the Secretary
determines such technologies, controls, or measures to be
appropriate to help mitigate the risk of abuse or misuse of
such drug or drugs, which may include by reducing the
availability of unused drugs.
``(2) Prior consultation.--The Secretary may not issue an
order under paragraph (1) unless the Secretary has consulted
with relevant stakeholders, through a public meeting, workshop,
or otherwise, about matters that are relevant to the subject of
the order.
``(3) Assuring access and minimizing burden.--Technologies,
controls, or measures required under paragraph (1) shall--
``(A) be commensurate with the specific risk of
abuse or misuse of the drug listed in the covered
application;
``(B) considering such risk, not be unduly
burdensome on patient access to the drug, considering
in particular any available evidence regarding the
expected or demonstrated public health impact of such
technologies, controls, or measures; and
``(C) reduce the risk of abuse or misuse of such
drug.
``(4) Order contents.--An order issued under paragraph (1)
may--
``(A) provide for a range of options for
implementing or modifying the technologies, controls,
or measures required to be implemented by such order;
and
``(B) incorporate by reference standards regarding
packaging or disposal set forth in an official
compendium, established by a nationally or
internationally recognized standard development
organization, or described on the public website of the
Food and Drug Administration, so long as the order
includes the rationale for incorporation of such
standard.
``(5) Orders applicable to drug class.--When a concern
about the risk of abuse or misuse of a drug relates to a
pharmacological class, the Secretary may, after consultation
with relevant stakeholders, issue an order under paragraph (1)
which applies to the pharmacological class.
``(b) Compliance.--The holder of a covered application shall--
``(1) submit a supplement containing proposed changes to
the covered application to comply with an order issued under
subsection (a) not later than--
``(A) 180 calendar days after the date on which the
order is issued; or
``(B)(i) such longer time period as specified by
the Secretary in such order; or
``(ii) if a request for an alternative date is
submitted by the holder of such application not later
than 60 calendar days after the date on which such
order is issued--
``(I) such requested alternative date if
agreed to by the Secretary; or
``(II) another date as specified by the
Secretary; and
``(2) implement the changes approved pursuant to such
supplement not later than the later of--
``(A) 90 calendar days after the date on which the
supplement is approved; or
``(B) the end of such longer period as is--
``(i) determined to be appropriate by the
Secretary; or
``(ii) approved by the Secretary pursuant
to a request by the holder of the covered
application that explains why such longer
period is needed, including to satisfy any
other applicable Federal statutory or
regulatory requirements.
``(c) Alternative Measures.--The holder of the covered application
may propose, and the Secretary shall approve, technologies, controls,
or measures regarding packaging, storage, or disposal other than those
specified in the applicable order issued under subsection (a), if such
technologies, controls, or measures are supported by data and
information demonstrating that such alternative technologies, controls,
or measures can be expected to mitigate the risk of abuse or misuse of
the drug or drugs involved, including by reducing the availability of
unused drugs, to at least the same extent as the technologies,
controls, or measures specified in such order.
``(d) Dispute Resolution.--If a dispute arises in connection with a
supplement submitted under subsection (b), the holder of the covered
application may appeal a determination made with respect to such
supplement using applicable dispute resolution procedures specified by
the Secretary in regulations or guidance.
``(e) Definitions.--In this section--
``(1) the term `covered application' means an application
submitted under subsection (b) or (j) of section 505 for
approval under such section or an application submitted under
section 351 of Public Health Service Act for approval under
such section, with respect to a drug that is or contains an
opioid for which a listing in schedule II or III (on a
temporary or permanent basis) is in effect under section 202 of
the Controlled Substances Act; and
``(2) the term `relevant stakeholders' may include
scientific experts within the drug manufacturing industry;
brand and generic drug manufacturers; standard development
organizations; wholesalers and distributors; payers; health
care providers; pharmacists; pharmacies; manufacturers; poison
centers; and representatives of the National Institute on Drug
Abuse, the National Institutes of Health, the Centers for
Disease Control and Prevention, the Centers for Medicare &
Medicaid Services, the Drug Enforcement Agency, the Consumer
Product Safety Commission, individuals who specialize in
treating addiction, and patient and caregiver groups.''.
(b) Prohibited Acts.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
``(k) If it is a drug approved under a covered application (as
defined in section 505-2(e)), the holder of which does not meet the
requirements of paragraphs (1) and (2) of subsection (b) of such
section.''.
(c) Required Content of an Abbreviated New Drug Application.--
Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(A)) is amended--
(1) in clause (vii)(IV), by striking ``and'' at the end;
(2) in clause (viii), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(ix) if the drug is or contains an opioid for which a
listing in schedule II or III (on a temporary or permanent
basis) is in effect under section 202 of the Controlled
Substances Act, information to show that the applicant has
proposed technologies, controls, or measures related to the
packaging or disposal of the drug that provide protections
comparable to those provided by the technologies, controls, or
measures required for the applicable listed drug under section
505-2, if applicable.''.
(d) Grounds for Refusing To Approve an Abbreviated New Drug
Application.--Section 505(j)(4) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(4)), is amended--
(1) in subparagraph (J), by striking ``or'' at the end;
(2) in subparagraph (K), by striking the period at the end
and inserting ``; or''; and
(3) by adding at the end the following:
``(L) if the drug is a drug described in paragraph
(2)(A)(ix) and the applicant has not proposed
technologies, controls, or measures related to the
packaging or disposal of such drug that the Secretary
determines provide protections comparable to those
provided by the technologies, controls, or measures
required for the applicable listed drug under section
505-2.''.
(e) Rules of Construction.--
(1) Any labeling describing technologies, controls, or
measures related to packaging or disposal intended to mitigate
the risk of abuse or misuse of a drug product that is subject
to an abbreviated new drug application, including labeling
describing differences from the reference listed drug resulting
from the application of section 505-2 of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), shall not
be construed--
(A) as changes to labeling not permissible under
clause (v) of section 505(j)(2)(A) of such Act (21
U.S.C. 355(j)(2)(A)), or a change in the conditions of
use prescribed, recommended, or suggested in the
labeling proposed for the new drug under clause (i) of
such section; or
(B) to preclude approval of an abbreviated new drug
application under subparagraph (B) or (G) of section
505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
(2) For a covered application that is an application
submitted under subsection (j) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection
(j)(2)(A) of such section 505 shall not be construed to limit
the type of data or information the Secretary of Health and
Human Services may request or consider in connection with
making any determination under section 505-2.
(f) 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 the 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) 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,
are made available to the public and barriers to the use of
such disposal products;
(3) identification of ways in which packaging technologies
are made available to the public and barriers to the use of
such technologies;
(4) a description of 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 these 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;
(5) a description of 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 these agencies, including unit dose packaging,
packaging that provides a set duration, or 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
(6) recommendations on--
(A) whether site-of-use, in-home controlled
substance disposal products and packaging technologies
require Federal oversight and, if so, which agencies
should be responsible for such oversight and, as
applicable, approval of such products or technologies;
and
(B) the potential role of the Federal Government in
evaluating such products to ensure product efficacy.
Subtitle W--Postapproval Study Requirements
SEC. 7221. POSTAPPROVAL STUDY REQUIREMENTS.
(a) Purposes of Study.--Section 505(o)(3)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is amended by adding at
the end the following:
``(iv) To assess a potential reduction in
effectiveness of the drug for the conditions of
use prescribed, recommended, or suggested in
the labeling thereof if--
``(I) the drug involved--
``(aa) is or contains a
substance for which a listing
in any schedule is in effect
(on a temporary or permanent
basis) under section 201 of the
Controlled Substances Act; or
``(bb) is a drug that has
not been approved under this
section or licensed under
section 351 of the Public
Health Service Act, for which
an application for such
approval or licensure is
pending or anticipated, and for
which the Secretary provides
notice to the sponsor that the
Secretary intends to issue a
scientific and medical
evaluation and recommend
controls under the Controlled
Substances Act; and
``(II) the potential reduction in
effectiveness could result in the
benefits of the drug no longer
outweighing the risks.''.
(b) Establishment of Requirement.--Section 505(o)(3)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(C)) is
amended by striking ``such requirement'' and all that follows through
``safety information.'' and inserting the following: ``such
requirement--
``(i) in the case of a purpose described in
clause (i), (ii), or (iii) of subparagraph (B),
only if the Secretary becomes aware of new
safety information; and
``(ii) in the case of a purpose described
in clause (iv) of such subparagraph, if the
Secretary determines that new effectiveness
information exists.''.
(c) Applicability.--Section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by adding at the end
the following new subparagraph:
``(G) Applicability.--The conduct of a study or
clinical trial required pursuant to this paragraph for
the purpose specified in subparagraph (B)(iv) shall not
be considered a new clinical investigation for the
purpose of a period of exclusivity under clause (iii)
or (iv) of subsection (c)(3)(E) or clause (iii) or (iv)
of subsection (j)(5)(F).''.
(d) New Effectiveness Information Defined.--Section 505(o)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(2)) is
amended by adding at the end the following new subparagraph:
``(D) New effectiveness information.--The term `new
effectiveness information', with respect to a drug that
is or contains a controlled substance for which a
listing in any schedule is in effect (on a temporary or
permanent basis) under section 201 of the Controlled
Substances Act, means new information about the
effectiveness of the drug, including a new analysis of
existing information, derived from--
``(i) a clinical trial; an adverse event
report; a postapproval study or clinical trial
(including a study or clinical trial under
paragraph (3));
``(ii) peer-reviewed biomedical literature;
``(iii) data derived from the postmarket
risk identification and analysis system under
subsection (k); or
``(iv) other scientific data determined to
be appropriate by the Secretary.''.
(e) Conforming Amendments With Respect to 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)--
(A) in the heading, by inserting ``or new
effectiveness'' after ``safety'';
(B) by striking ``safety information'' and
inserting ``new safety information or new effectiveness
information such''; and
(C) by striking ``believes should be'' and
inserting ``believes changes should be made to'';
(2) in subparagraph (B)(i)--
(A) by striking ``new safety information'' and by
inserting ``new safety information or new effectiveness
information''; and
(B) by inserting ``indications,'' after ``boxed
warnings,'';
(3) in subparagraph (C), by inserting ``or new
effectiveness information'' after ``safety information''; and
(4) in subparagraph (E), by inserting ``or new
effectiveness information'' after ``safety information''.
(f) Rule of Construction.--Nothing in the amendments made by this
section shall be construed to alter, in any manner, the meaning or
application of the provisions of paragraph (3) of section 505(o) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) with respect to
the authority of the Secretary of Health and Human Services to require
a postapproval study or clinical trial for a purpose specified in
clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or
paragraph (4) of such section 505(o) with respect to the Secretary's
authority to require safety labeling changes.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
SEC. 8001. SHORT TITLE; TABLE OF CONTENTS.
This subtitle may be cited as the ``Synthetics Trafficking and
Overdose Prevention Act of 2018'' or ``STOP Act of 2018''.
SEC. 8002. CUSTOMS FEES.
(a) In General.--Section 13031(b)(9) of the Consolidated Omnibus
Budget Reconciliation Act of 1985 (19 U.S.C. 58c(b)(9)) is amended by
adding at the end the following:
``(D)(i) With respect to the processing of items that are
sent to the United States through the international postal
network by `Inbound Express Mail service' or `Inbound EMS' (as
that service is described in the mail classification schedule
referred to in section 3631 of title 39, United States Code),
the following payments are required:
``(I) $1 per Inbound EMS item.
``(II) If an Inbound EMS item is formally entered,
the fee provided for under subsection (a)(9), if
applicable.
``(ii) Notwithstanding section 451 of the Tariff Act of
1930 (19 U.S.C. 1451), the payments required by clause (i), as
allocated pursuant to clause (iii)(I), shall be the only
payments required for reimbursement of U.S. Customs and Border
Protection for customs services provided in connection with the
processing of an Inbound EMS item.
``(iii)(I) The payments required by clause (i)(I) shall be
allocated as follows:
``(aa) 50 percent of the amount of the payments
shall be paid on a quarterly basis by the United States
Postal Service to the Commissioner of U.S. Customs and
Border Protection in accordance with regulations
prescribed by the Secretary of the Treasury to
reimburse U.S. Customs and Border Protection for
customs services provided in connection with the
processing of Inbound EMS items.
``(bb) 50 percent of the amount of the payments
shall be retained by the Postal Service to reimburse
the Postal Service for services provided in connection
with the customs processing of Inbound EMS items.
``(II) Payments received by U.S. Customs and Border
Protection under subclause (I)(aa) shall, in accordance with
section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be
deposited in the Customs User Fee Account and used to directly
reimburse each appropriation for the amount paid out of that
appropriation for the costs incurred in providing services to
international mail facilities. Amounts deposited in accordance
with the preceding sentence shall be available until expended
for the provision of such services.
``(III) Payments retained by the Postal Service under
subclause (I)(bb) shall be used to directly reimburse the
Postal Service for the costs incurred in providing services in
connection with the customs processing of Inbound EMS items.
``(iv) Beginning in fiscal year 2021, the Secretary, in
consultation with the Postmaster General, may adjust, not more
frequently than once each fiscal year, the amount described in
clause (i)(I) to an amount commensurate with the costs of
services provided in connection with the customs processing of
Inbound EMS items, consistent with the obligations of the
United States under international agreements.''.
(b) Conforming Amendments.--Section 13031(a) of the Consolidated
Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(a)) is
amended--
(1) in paragraph (6), by inserting ``(other than an item
subject to a fee under subsection (b)(9)(D))'' after ``customs
officer''; and
(2) in paragraph (10)--
(A) in subparagraph (C), in the matter preceding
clause (i), by inserting ``(other than Inbound EMS
items described in subsection (b)(9)(D))'' after
``release''; and
(B) in the flush at the end, by inserting ``or of
Inbound EMS items described in subsection (b)(9)(D),''
after ``(C),''.
(c) Effective Date.--The amendments made by this section shall take
effect on January 1, 2020.
SEC. 8003. MANDATORY ADVANCE ELECTRONIC INFORMATION FOR POSTAL
SHIPMENTS.
(a) Mandatory Advance Electronic Information.--
(1) In general.--Section 343(a)(3)(K) of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended to
read as follows:
``(K)(i) The Secretary shall prescribe regulations
requiring the United States Postal Service to transmit
the information described in paragraphs (1) and (2) to
the Commissioner of U.S. Customs and Border Protection
for international mail shipments by the Postal Service
(including shipments to the Postal Service from foreign
postal operators that are transported by private
carrier) consistent with the requirements of this
subparagraph.
``(ii) In prescribing regulations under clause (i),
the Secretary shall impose requirements for the
transmission to the Commissioner of information
described in paragraphs (1) and (2) for mail shipments
described in clause (i) that are comparable to the
requirements for the transmission of such information
imposed on similar non-mail shipments of cargo, taking
into account the parameters set forth in subparagraphs
(A) through (J).
``(iii) The regulations prescribed under clause (i)
shall require the transmission of the information
described in paragraphs (1) and (2) with respect to a
shipment as soon as practicable in relation to the
transportation of the shipment, consistent with
subparagraph (H).
``(iv) Regulations prescribed under clause (i)
shall allow for the requirements for the transmission
to the Commissioner of information described in
paragraphs (1) and (2) for mail shipments described in
clause (i) to be implemented in phases, as appropriate,
by--
``(I) setting incremental targets for
increasing the percentage of such shipments for
which information is required to be transmitted
to the Commissioner; and
``(II) taking into consideration--
``(aa) the risk posed by such
shipments;
``(bb) the volume of mail shipped
to the United States by or through a
particular country; and
``(cc) the capacities of foreign
postal operators to provide that
information to the Postal Service.
``(v)(I) Notwithstanding clause (iv), the Postal
Service shall, not later than December 31, 2018,
arrange for the transmission to the Commissioner of the
information described in paragraphs (1) and (2) for not
less than 70 percent of the aggregate number of mail
shipments, including 100 percent of mail shipments from
the People's Republic of China, described in clause
(i).
``(II) If the requirements of subclause (I) are not
met, the Comptroller General of the United States shall
submit to the appropriate congressional committees, not
later than June 30, 2019, a report--
``(aa) assessing the reasons for the
failure to meet those requirements; and
``(bb) identifying recommendations to
improve the collection by the Postal Service of
the information described in paragraphs (1) and
(2).
``(vi)(I) Notwithstanding clause (iv), the Postal
Service shall, not later than December 31, 2020,
arrange for the transmission to the Commissioner of the
information described in paragraphs (1) and (2) for 100
percent of the aggregate number of mail shipments
described in clause (i).
``(II) The Commissioner, in consultation with the
Postmaster General, may determine to exclude a country
from the requirement described in subclause (I) to
transmit information for mail shipments described in
clause (i) from the country if the Commissioner
determines that the country--
``(aa) does not have the capacity to
collect and transmit such information;
``(bb) represents a low risk for mail
shipments that violate relevant United States
laws and regulations; and
``(cc) accounts for low volumes of mail
shipments that can be effectively screened for
compliance with relevant United States laws and
regulations through an alternate means.
``(III) The Commissioner shall, at a minimum on an
annual basis, re-evaluate any determination made under
subclause (II) to exclude a country from the
requirement described in subclause (I). If, at any
time, the Commissioner determines that a country no
longer meets the requirements under subclause (II), the
Commissioner may not further exclude the country from
the requirement described in subclause (I).
``(IV) The Commissioner shall, on an annual basis,
submit to the appropriate congressional committees--
``(aa) a list of countries with respect to
which the Commissioner has made a determination
under subclause (II) to exclude the countries
from the requirement described in subclause
(I); and
``(bb) information used to support such
determination with respect to such countries.
``(vii)(I) The Postmaster General shall, in
consultation with the Commissioner, refuse any
shipments received after December 31, 2020, for which
the information described in paragraphs (1) and (2) is
not transmitted as required under this subparagraph,
except as provided in subclause (II).
``(II) If remedial action is warranted in lieu of
refusal of shipments pursuant to subclause (I), the
Postmaster General and the Commissioner shall take
remedial action with respect to the shipments,
including destruction, seizure, controlled delivery or
other law enforcement initiatives, or correction of the
failure to provide the information described in
paragraphs (1) and (2) with respect to the shipments.
``(viii) Nothing in this subparagraph shall be
construed to limit the authority of the Secretary to
obtain information relating to international mail
shipments from private carriers or other appropriate
parties.
``(ix) In this subparagraph, the term `appropriate
congressional committees' means--
``(I) the Committee on Finance and the
Committee on Homeland Security and Governmental
Affairs of the Senate; and
``(II) the Committee on Ways and Means, the
Committee on Oversight and Government Reform,
and the Committee on Homeland Security of the
House of Representatives.''.
(2) Joint strategic plan on mandatory advance
information.--Not later than 60 days after the date of the
enactment of this Act, the Secretary of Homeland Security and
the Postmaster General shall develop and submit to the
appropriate congressional committees a joint strategic plan
detailing specific performance measures for achieving--
(A) the transmission of information as required by
section 343(a)(3)(K) of the Trade Act of 2002, as
amended by paragraph (1); and
(B) the presentation by the Postal Service to U.S.
Customs and Border Protection of all mail targeted by
U.S. Customs and Border Protection for inspection.
(b) Capacity Building.--
(1) In general.--Section 343(a) of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended by adding
at the end the following:
``(5) Capacity building.--
``(A) In general.--The Secretary, with the
concurrence of the Secretary of State, and in
coordination with the Postmaster General and the heads
of other Federal agencies, as appropriate, may provide
technical assistance, equipment, technology, and
training to enhance the capacity of foreign postal
operators--
``(i) to gather and provide the information
required by paragraph (3)(K); and
``(ii) to otherwise gather and provide
postal shipment information related to--
``(I) terrorism;
``(II) items the importation or
introduction of which into the United
States is prohibited or restricted,
including controlled substances; and
``(III) such other concerns as the
Secretary determines appropriate.
``(B) Provision of equipment and technology.--With
respect to the provision of equipment and technology
under subparagraph (A), the Secretary may lease, loan,
provide, or otherwise assist in the deployment of such
equipment and technology under such terms and
conditions as the Secretary may prescribe, including
nonreimbursable loans or the transfer of ownership of
equipment and technology.''.
(2) Joint strategic plan on capacity building.--Not later
than 1 year after the date of the enactment of this Act, the
Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
develop and submit to the appropriate congressional committees
a joint strategic plan--
(A) detailing the extent to which U.S. Customs and
Border Protection and the United States Postal Service
are engaged in capacity building efforts under section
343(a)(5) of the Trade Act of 2002, as added by
paragraph (1);
(B) describing plans for future capacity building
efforts; and
(C) assessing how capacity building has increased
the ability of U.S. Customs and Border Protection and
the Postal Service to advance the goals of this
subtitle and the amendments made by this subtitle.
(c) Report and Consultations by Secretary of Homeland Security and
Postmaster General.--
(1) Report.--Not later than 180 days after the date of the
enactment of this Act, and annually thereafter until 3 years
after the Postmaster General has met the requirement under
clause (vi) of subparagraph (K) of section 343(a)(3) of the
Trade Act of 2002, as amended by subsection (a)(1), the
Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
submit to the appropriate congressional committees a report on
compliance with that subparagraph that includes the following:
(A) An assessment of the status of the regulations
required to be promulgated under that subparagraph.
(B) An update regarding new and existing agreements
reached with foreign postal operators for the
transmission of the information required by that
subparagraph.
(C) A summary of deliberations between the United
States Postal Service and foreign postal operators with
respect to issues relating to the transmission of that
information.
(D) A summary of the progress made in achieving the
transmission of that information for the percentage of
shipments required by that subparagraph.
(E) An assessment of the quality of that
information being received by foreign postal operators,
as determined by the Secretary of Homeland Security,
and actions taken to improve the quality of that
information.
(F) A summary of policies established by the
Universal Postal Union that may affect the ability of
the Postmaster General to obtain the transmission of
that information.
(G) A summary of the use of technology to detect
illicit synthetic opioids and other illegal substances
in international mail parcels and planned acquisitions
and advancements in such technology.
(H) Such other information as the Secretary of
Homeland Security and the Postmaster General consider
appropriate with respect to obtaining the transmission
of information required by that subparagraph.
(2) Consultations.--Not later than 180 days after the date
of the enactment of this Act, and every 180 days thereafter
until the Postmaster General has met the requirement under
clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002,
as amended by subsection (a)(1), to arrange for the
transmission of information with respect to 100 percent of the
aggregate number of mail shipments described in clause (i) of
that section, the Secretary of Homeland Security and the
Postmaster General shall provide briefings to the appropriate
congressional committees on the progress made in achieving the
transmission of that information for that percentage of
shipments.
(d) Government Accountability Office Report.--Not later than June
30, 2019, the Comptroller General of the United States shall submit to
the appropriate congressional committees a report--
(1) assessing the progress of the United States Postal
Service in achieving the transmission of the information
required by subparagraph (K) of section 343(a)(3) of the Trade
Act of 2002, as amended by subsection (a)(1), for the
percentage of shipments required by that subparagraph;
(2) assessing the quality of the information received from
foreign postal operators for targeting purposes;
(3) assessing the specific percentage of targeted mail
presented by the Postal Service to U.S. Customs and Border
Protection for inspection;
(4) describing the costs of collecting the information
required by such subparagraph (K) from foreign postal operators
and the costs of implementing the use of that information;
(5) assessing the benefits of receiving that information
with respect to international mail shipments;
(6) assessing the feasibility of assessing a customs fee
under section 13031(b)(9) of the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended by section 8002, on
international mail shipments other than Inbound Express Mail
service in a manner consistent with the obligations of the
United States under international agreements; and
(7) identifying recommendations, including recommendations
for legislation, to improve the compliance of the Postal
Service with such subparagraph (K), including an assessment of
whether the detection of illicit synthetic opioids in the
international mail would be improved by--
(A) requiring the Postal Service to serve as the
consignee for international mail shipments containing
goods; or
(B) designating a customs broker to act as an
importer of record for international mail shipments
containing goods.
(e) Technical Correction.--Section 343 of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended in the section
heading by striking ``advanced'' and inserting ``advance''.
(f) Appropriate Congressional Committees Defined.--In this section,
the term ``appropriate congressional committees'' means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on Homeland
Security of the House of Representatives.
SEC. 8004. INTERNATIONAL POSTAL AGREEMENTS.
(a) Existing Agreements.--
(1) In general.--In the event that any provision of this
subtitle, or any amendment made by this Act, is determined to
be in violation of obligations of the United States under any
postal treaty, convention, or other international agreement
related to international postal services, or any amendment to
such an agreement, the Secretary of State should negotiate to
amend the relevant provisions of the agreement so that the
United States is no longer in violation of the agreement.
(2) Rule of construction.--Nothing in this subsection shall
be construed to permit delay in the implementation of this
subtitle or any amendment made by this subtitle.
(b) Future Agreements.--
(1) Consultations.--Before entering into, on or after the
date of the enactment of this Act, any postal treaty,
convention, or other international agreement related to
international postal services, or any amendment to such an
agreement, that is related to the ability of the United States
to secure the provision of advance electronic information by
foreign postal operators, the Secretary of State should consult
with the appropriate congressional committees (as defined in
section 8003(f)).
(2) Expedited negotiation of new agreement.--To the extent
that any new postal treaty, convention, or other international
agreement related to international postal services would
improve the ability of the United States to secure the
provision of advance electronic information by foreign postal
operators as required by regulations prescribed under section
343(a)(3)(K) of the Trade Act of 2002, as amended by section
8003(a)(1), the Secretary of State should expeditiously
conclude such an agreement.
SEC. 8005. COST RECOUPMENT.
(a) In General.--The United States Postal Service shall, to the
extent practicable and otherwise recoverable by law, ensure that all
costs associated with complying with this subtitle and amendments made
by this subtitle are charged directly to foreign shippers or foreign
postal operators.
(b) Costs Not Considered Revenue.--The recovery of costs under
subsection (a) shall not be deemed revenue for purposes of subchapter I
and II of chapter 36 of title 39, United States Code, or regulations
prescribed under that chapter.
SEC. 8006. DEVELOPMENT OF TECHNOLOGY TO DETECT ILLICIT NARCOTICS.
(a) In General.--The Postmaster General and the Commissioner of
U.S. Customs and Border Protection, in coordination with the heads of
other agencies as appropriate, shall collaborate to identify and
develop technology for the detection of illicit fentanyl, other
synthetic opioids, and other narcotics and psychoactive substances
entering the United States by mail.
(b) Outreach to Private Sector.--The Postmaster General and the
Commissioner shall conduct outreach to private sector entities to
gather information regarding the current state of technology to
identify areas for innovation relating to the detection of illicit
fentanyl, other synthetic opioids, and other narcotics and psychoactive
substances entering the United States.
SEC. 8007. CIVIL PENALTIES FOR POSTAL SHIPMENTS.
Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is amended
by adding at the end the following new subsection:
``(e) Civil Penalties for Postal Shipments.--
``(1) Civil penalty.--A civil penalty shall be imposed
against the United States Postal Service if the Postal Service
accepts a shipment in violation of section 343(a)(3)(K)(vii)(I)
of the Trade Act of 2002.
``(2) Modification of civil penalty.--
``(A) In general.--U.S. Customs and Border
Protection shall reduce or dismiss a civil penalty
imposed pursuant to paragraph (1) if U.S. Customs and
Border Protection determines that the United States
Postal Service--
``(i) has a low error rate in compliance
with section 343(a)(3)(K) of the Trade Act of
2002;
``(ii) is cooperating with U.S. Customs and
Border Protection with respect to the violation
of section 343(a)(3)(K)(vii)(I) of the Trade
Act of 2002; or
``(iii) has taken remedial action to
prevent future violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002.
``(B) Written notification.--U.S. Customs and
Border Protection shall issue a written notification to
the Postal Service with respect to each exercise of the
authority of subparagraph (A) to reduce or dismiss a
civil penalty imposed pursuant to paragraph (1).
``(3) Ongoing lack of compliance.--If U.S. Customs and
Border Protection determines that the United States Postal
Service--
``(A) has repeatedly committed violations of
section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002,
``(B) has failed to cooperate with U.S. Customs and
Border Protection with respect to violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and
``(C) has an increasing error rate in compliance
with section 343(a)(3)(K) of the Trade Act of 2002,
civil penalties may be imposed against the United States Postal
Service until corrective action, satisfactory to U.S. Customs
and Border Protection, is taken.''.
SEC. 8008. REPORT ON VIOLATIONS OF ARRIVAL, REPORTING, ENTRY, AND
CLEARANCE REQUIREMENTS AND FALSITY OR LACK OF MANIFEST.
(a) In General.--The Commissioner of U.S. Customs and Border
Protection shall submit to the appropriate congressional committees an
annual report that contains the information described in subsection (b)
with respect to each violation of section 436 of the Tariff Act of 1930
(19 U.S.C. 1436), as amended by section 8007, and section 584 of such
Act (19 U.S.C. 1584) that occurred during the previous year.
(b) Information Described.--The information described in this
subsection is the following:
(1) The name and address of the violator.
(2) The specific violation that was committed.
(3) The location or port of entry through which the items
were transported.
(4) An inventory of the items seized, including a
description of the items and the quantity seized.
(5) The location from which the items originated.
(6) The entity responsible for the apprehension or seizure,
organized by location or port of entry.
(7) The amount of penalties assessed by U.S. Customs and
Border Protection, organized by name of the violator and
location or port of entry.
(8) The amount of penalties that U.S. Customs and Border
Protection could have levied, organized by name of the violator
and location or port of entry.
(9) The rationale for negotiating lower penalties,
organized by name of the violator and location or port of
entry.
(c) Appropriate Congressional Committees Defined.--In this section,
the term ``appropriate congressional committees'' means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on Homeland
Security of the House of Representatives.
SEC. 8009. EFFECTIVE DATE; REGULATIONS.
(a) Effective Date.--This subtitle and the amendments made by this
subtitle (other than the amendments made by section 8002) shall take
effect on the date of the enactment of this Act.
(b) Regulations.--Not later than 1 year after the date of the
enactment of this Act, such regulations as are necessary to carry out
this subtitle and the amendments made by this subtitle shall be
prescribed.
Subtitle B--Recognizing Early Childhood Trauma Related to Substance
Abuse
SEC. 8011. SHORT TITLE.
This subtitle may be cited as the ``Recognizing Early Childhood
Trauma Related to Substance Abuse Act of 2018''.
SEC. 8012. 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 related to substance abuse 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 due to exposure to substance
abuse;
(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 due to exposure to substance abuse 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 prevent separation and support re-unification of families
whenever possible and in the best interest of the child.
(c) 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 C--Assisting States' Implementation of Plans of Safe Care
SEC. 8021. SHORT TITLE.
This subtitle may be cited as the ``Assisting States'
Implementation of Plans of Safe Care Act''.
SEC. 8022. ASSISTING STATES WITH IMPLEMENTATION OF PLANS OF SAFE CARE.
(a) In General.--The Secretary of Health and Human Services shall
provide written guidance and, if appropriate, technical assistance to
support States in complying with, and implementing, subsections
(b)(2)(B)(iii) and (d)(18) of section 106 of the Child Abuse Prevention
and Treatment Act (42 U.S.C. 5106a) in order to promote better
protections for young children and family-centered responses.
(b) Requirements.--The guidance and technical assistance shall--
(1) enhance States' understanding of requirements and
flexibilities under the law, including clarifying key terms;
(2) address State-identified challenges with developing,
implementing, and monitoring plans of safe care;
(3) disseminate best practices related to developing and
implementing plans of safe care, including differential
response, collaboration and coordination, and identification
and delivery of services, while recognizing needs of different
populations and varying community approaches across States;
(4) support collaboration between health care providers,
social service agencies, public health agencies, and the child
welfare system, to promote a family-centered treatment
approach;
(5) prevent separation and support reunification of
families if in the best interests of the child;
(6) recommend treatment approaches for serving infants,
pregnant women, and postpartum women whose infants may be
affected by substance use that are designed to keep infants
with their mothers and families whenever appropriate, including
recommendations to encourage pregnant women to receive health
and other support services during pregnancy;
(7) support State efforts to develop technology systems to
manage and monitor implementation of plans of safe care; and
(8) help States improve the long-term safety and well-being
of young children and their families.
(c) Construction.--The guidance and technical assistance shall not
be construed to amend the requirements of the Child Abuse Prevention
and Treatment Act (42 U.S.C. 5101 et seq.).
(d) Definition.--For purposes of this section, the term ``State''
has the meaning given such term in section 3 of the Child Abuse
Prevention and Treatment Act (42 U.S.C. 5101 note).
Subtitle D--Improving the Federal Response to Families Impacted by
Substance Use Disorder
SEC. 8031. SHORT TITLE.
This subtitle may be cited as the ``Improving the Federal Response
to Families Impacted by Substance Use Disorder Act''.
SEC. 8032. INTERAGENCY TASK FORCE TO IMPROVE THE FEDERAL RESPONSE TO
FAMILIES IMPACTED BY SUBSTANCE USE DISORDERS.
(a) Establishment.--There is established a task force, to be known
as the ``Interagency Task Force to Improve the Federal Response to
Families Impacted by Substance Use Disorders'' (in this section
referred to as ``Task Force'').
(b) Responsibilities.--The Task Force--
(1) shall identify, evaluate, and recommend ways in which
Federal agencies can better coordinate responses to substance
use disorders and the opioid crisis; and
(2) shall carry out the additional duties described in
subsection (d).
(c) Membership.--
(1) Number and appointment.--The Task Force shall be
composed of 12 Federal officials having responsibility for, or
administering programs related to, the duties of the Task
Force. The Secretary of Health and Human Services, the
Secretary of Education, the Secretary of Agriculture, and the
Secretary of Labor shall each appoint two members to the Task
Force from among the Federal officials employed by the
Department of which they are the head. Additional Federal
agency officials appointed by the Secretary of Health and Human
Services shall fill the remaining positions of the Task Force.
(2) Chairperson.--The Secretary of Health and Human
Services shall designate a Federal official employed by the
Department of Health and Human Services to serve as the
chairperson of the Task Force.
(3) Deadline for appointment.--Each member shall be
appointed to the Task Force not later than 60 days after the
date of the enactment of this Act.
(4) Additional agency input.--The Task Force may seek input
from other Federal agencies and offices with experience,
expertise, or information relevant in responding to the opioid
crisis.
(5) Vacancies.--A vacancy in the Task Force shall be filled
in the manner in which the original appointment was made.
(6) Prohibition of compensation.--Members of the Task Force
may not receive pay, allowances, or benefits by reason of their
service on the Task Force.
(d) Duties.--The Task Force shall carry out the following duties:
(1) Solicit input from stakeholders, including frontline
service providers, medical professionals, educators, mental
health professionals, researchers, experts in infant, child,
and youth trauma, child welfare professionals, and the public,
in order to inform the activities of the Task Force.
(2) Develop a strategy on how the Task Force and
participating Federal agencies will collaborate, prioritize,
and implement a coordinated Federal approach with regard to
responding to substance use disorders, including opioid misuse,
that shall include--
(A) identifying options for the coordination of
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 abuse disorders, including opioid misuse;
and
(B) 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, including
opioid misuse.
(3) Based off the strategy developed under paragraph (2),
evaluate and recommend opportunities for local- and State-level
partnerships, professional development, or best practices
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
substance abuse;
(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
substance use disorders, including opioid misuse;
(C) offer community-based prevention activities,
including educating families and children on the
effects of exposure to substance use disorders,
including opioid misuse, 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 substance use disorders, including opioid
misuse; and
(E) are designed to prevent separation and support
reunification of families if in the best interest of
the child.
(4) In fulfilling the requirements of paragraphs (2) and
(3), consider evidence-based, evidence-informed, and promising
best practices related to identifying, referring, and
supporting children and families at risk of experiencing
exposure to substance abuse or experiencing substance use
disorder, including opioid misuse, including--
(A) prevention strategies for those at risk of
experiencing or being exposed to substance abuse,
including misuse of opioids;
(B) whole-family and multi-generational approaches;
(C) community-based initiatives;
(D) referral to, and implementation of, trauma-
informed practices and supports; and
(E) multi-generational practices that assist
parents, foster parents, and kinship and other
caregivers
(e) FACA.--The Federal Advisory Committee Act (5 U.S.C. App. 2)
shall not apply to the Task Force.
(f) Action Plan; Reports.--The Task Force--
(1) shall prepare a detailed action plan to be implemented
by participating Federal agencies to create a collaborative,
coordinated response to the opioid crisis, which shall
include--
(A) relevant information identified and collected
under subsection (d);
(B) a proposed timeline for implementing
recommendations and efforts identified under subsection
(d); and
(C) a description of how other Federal agencies and
offices with experience, expertise, or information
relevant in responding to the opioid crisis that have
provided input under subsection (c)(4) will be
participating in the coordinated approach;
(2) shall submit to the Congress a report describing the
action plan prepared under paragraph (1), including, where
applicable, identification of any recommendations included in
such plan that require additional legislative authority to
implement; and
(3) shall submit a report to the Governors describing the
opportunities for local- and State-level partnerships,
professional development, or best practices recommended under
subsection (d)(3).
(g) Dissemination.--
(1) In general.--The action plan and reports required under
subsection (f) shall be--
(A) disseminated widely, including among the
participating Federal agencies and the Governors; and
(B) be made publicly available online in an
accessible format.
(2) Deadline.--The action plan and reports required under
subsection (f) may be released on separate dates but shall be
released not later than 9 months after the date of the
enactment of this Act.
(h) Termination.--The Task Force shall terminate 30 days after the
dissemination of the action plan and reports under subsection (g).
(i) Funding.--The administrative expenses of the Task Force shall
be paid out of existing Department of Health and Human Services funds
or appropriations.
(j) Definitions.--For purposes of this section:
(1) The term ``Governor'' means the chief executive officer
of a State.
(2) The term ``participating Federal agencies'' means all
the Executive agencies (as defined in section 105 of title 5,
United States Code) whose officials have been appointed to the
Task Force.
(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.
Subtitle E--Establishment of an Advisory Committee on Opioids and the
Workplace
SEC. 8041. ESTABLISHMENT OF AN ADVISORY COMMITTEE ON OPIOIDS AND THE
WORKPLACE.
(a) Establishment.--Not later than 90 days after enactment of this
Act, the Secretary of Labor shall establish an Advisory Committee on
Opioids and the Workplace (referred to in this subtitle as the
``Advisory Committee'') to advise the Secretary on actions the
Department of Labor can take to provide informational resources and
best practices on how to appropriately address the impact of opioid
abuse on the workplace and support workers abusing opioids.
(b) Membership.--
(1) Composition.--The Secretary of Labor shall appoint as
members of the Advisory Committee 19 individuals with expertise
in employment, workplace health programs, human resources,
substance use disorder, and other relevant fields. The Advisory
Committee shall be composed as follows:
(A) Four of the members shall be individuals
representative of employers or other organizations
representing employers.
(B) Four of the members shall be individuals
representative of workers or other organizations
representing workers, of which at least two must be
representatives designated by labor organizations.
(C) Three of the members shall be individuals
representative of health benefit plans, employee
assistance plan providers, workers' compensation
program administrators, and workplace safety and health
professionals.
(D) Eight of the members shall be individuals
representative of substance abuse treatment and
recovery experts, including medical doctors, licensed
addiction therapists, and scientific and academic
researchers, of which one individual may be a
representative of a local or State government agency
that oversees or coordinates programs that address
substance use disorder.
(2) Chair.--From the members appointed under paragraph (1),
the Secretary of Labor shall appoint a chairperson.
(3) Terms.--Each member of the Advisory Committee shall
serve for a term of 3 years. A member appointed to fill a
vacancy shall be appointed only for the remainder of such term.
(4) Quorum.--A majority of members of the Advisory
Committee shall constitute a quorum and action shall be taken
only by a majority vote of the members.
(5) Voting.--The Advisory Committee shall establish voting
procedures.
(6) No compensation.--Members of the Advisory Committee
shall serve without compensation.
(7) Disclosure.--Every member of the Advisory Committee
must disclose the entity, if applicable, that he or she is
representing.
(c) Duties.--
(1) Advisement.--
(A) In general.--The Advisory Committee established
under subsection (a) shall advise the Secretary of
Labor on actions the Department of Labor can take to
provide informational resources and best practices on
how to appropriately address the impact of opioid abuse
on the workplace and support workers abusing opioids.
(B) Considerations.--In providing such advice, the
Advisory Committee shall take into account--
(i) evidence-based and other employer
substance abuse policies and best practices
regarding opioid use or abuse, including
benefits provided by employee assistance
programs or other employer-provided benefits,
programs, or resources;
(ii) the effect of opioid use or abuse on
the safety of the workplace as well as policies
and procedures addressing workplace safety and
health;
(iii) the impact of opioid abuse on
productivity and absenteeism, and assessments
of model human resources policies that support
workers abusing opioids, such as policies that
facilitate seeking and receiving treatment and
returning to work;
(iv) the extent to which alternative pain
management treatments other than opioids are or
should be covered by employer-sponsored health
plans;
(v) the legal requirements protecting
employee privacy and health information in the
workplace, as well as the legal requirements
related to nondiscrimination;
(vi) potential interactions of opioid abuse
with other substance use disorders;
(vii) any additional benefits or resources
available to an employee abusing opioids that
promote retaining employment or reentering the
workforce;
(viii) evidence-based initiatives that
engage employers, employees, and community
leaders to promote early identification of
opioid abuse, intervention, treatment, and
recovery;
(ix) workplace policies regarding opioid
abuse that reduce stigmatization among fellow
employees and management; and
(x) the legal requirements of the Mental
Health Parity and Addiction Equity Act and
other laws related to health coverage of
substance abuse and mental health services and
medications.
(2) Report.--Prior to its termination as provided in
subsection (j), the Advisory Committee shall issue a report to
the Secretary of Labor and to the Committee on Education and
the Workforce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate,
detailing successful programs and policies involving workplace
resources and benefits, including recommendations or examples
of best practices for how employers can support and respond to
employees impacted by opioid abuse.
(d) Meetings.--The Advisory Committee shall meet at least twice a
year at the call of the chairperson.
(e) Staff Support.--The Secretary of Labor shall make available
staff necessary for the Advisory Committee to carry out its
responsibilities.
(f) Federal Advisory Committee Act.--The Federal Advisory Committee
Act shall apply to the Advisory Committee established under this
subtitle.
(g) No Appropriated Funds.--No additional funds are authorized to
be appropriated to carry out this subtitle. Expenses of the Advisory
Committee shall be paid with funds otherwise appropriated to
Departmental Management within the Department of Labor.
(h) Ex Officio.--Three nonvoting representatives from agencies
within the Department of Health and Human Services whose
responsibilities include opioid prescribing guidelines, workplace
safety, and monitoring of substance abuse and prevention programs shall
be appointed by the Secretary of Labor and designated as ex officio
members.
(i) Agenda.--The Secretary of Labor or a representative of the
Secretary shall consult with the Chair in establishing the agenda for
Committee meetings.
(j) Termination.--The Advisory Committee established under this
subtitle shall terminate 3 years after the date of enactment of this
Act.
Subtitle F--Veterans Treatment Court Improvement
SEC. 8051. SHORT TITLE.
This subtitle may be cited as the ``Veterans Treatment Court
Improvement Act of 2018''.
SEC. 8052. HIRING BY DEPARTMENT OF VETERANS AFFAIRS OF ADDITIONAL
VETERANS JUSTICE OUTREACH SPECIALISTS.
(a) Hiring of Additional Veterans Justice Outreach Specialists.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, the Secretary of Veterans Affairs
shall hire not fewer than 50 Veterans Justice Outreach
Specialists and place each such Veterans Justice Outreach
Specialist at an eligible Department of Veterans Affairs
medical center in accordance with this section.
(2) Requirements.--The Secretary shall ensure that each
Veterans Justice Outreach Specialist employed under paragraph
(1)--
(A) serves, either exclusively or in addition to
other duties, as part of a justice team in a veterans
treatment court or other veteran-focused court; and
(B) otherwise meets Department hiring guidelines
for Veterans Justice Outreach Specialists.
(b) Eligible Department of Veterans Affairs Medical Centers.--For
purposes of this section, an eligible Department of Veterans Affairs
medical center is any Department of Veterans Affairs medical center
that--
(1) complies with all Department guidelines and regulations
for placement of a Veterans Justice Outreach Specialist;
(2) works within a local criminal justice system with
justice-involved veterans;
(3) maintains an affiliation with one or more veterans
treatment courts or other veteran-focused courts; and
(4) either--
(A) routinely provides Veterans Justice Outreach
Specialists to serve as part of a justice team in a
veterans treatment court or other veteran-focused
court; or
(B) establishes a plan that is approved by the
Secretary to provide Veterans Justice Outreach
Specialists employed under subsection (a)(1) to serve
as part of a justice team in a veterans treatment court
or other veteran-focused court.
(c) Placement Priority.--The Secretary shall prioritize the
placement of Veterans Justice Outreach Specialists employed under
subsection (a)(1) at eligible Department of Veterans Affairs medical
centers that have or intend to establish an affiliation, for the
purpose of carrying out the Veterans Justice Outreach Program, with a
veterans treatment court, or other veteran-focused court, that--
(1) was established on or after the date of the enactment
of this Act; or
(2)(A) was established before the date of the enactment of
this Act; and
(B) is not fully staffed with Veterans Justice Outreach
Specialists.
(d) Reports.--
(1) Report by secretary of veterans affairs.--
(A) In general.--Not later than 1 year after the
date of the enactment of this Act, the Secretary of
Veterans Affairs shall submit to Congress a report on
the implementation of this section and its effect on
the Veterans Justice Outreach Program.
(B) Contents.--The report submitted under paragraph
(1) shall include the following:
(i) The status of the efforts of the
Secretary to hire Veterans Justice Outreach
Specialists pursuant to subsection (a)(1),
including the total number of Veterans Justice
Outreach Specialists hired by the Secretary
pursuant to such subsection and the number that
the Secretary expects to hire pursuant to such
subsection.
(ii) The total number of Veterans Justice
Outreach Specialists assigned to each
Department of Veterans Affairs medical center
that participates in the Veterans Justice
Outreach Program, including the number of
Veterans Justice Outreach Specialists hired
under subsection (a)(1) disaggregated by
Department of Veterans Affairs medical center.
(iii) The total number of eligible
Department of Veterans Affairs medical centers
that sought placement of a Veterans Justice
Outreach Specialist under subsection (a)(1),
how many Veterans Justice Outreach Specialists
each such center sought, and how many of such
medical centers received no placement of a
Veterans Justice Outreach Specialist under
subsection (a)(1).
(iv) For each eligible Department of
Veterans Affairs medical center--
(I) the number of justice-involved
veterans who were served or are
expected to be served by a Veterans
Justice Outreach Specialist hired under
subsection (a)(1); and
(II) the number of justice-involved
veterans who do not have access to a
Veterans Justice Outreach Specialist.
(2) Report by comptroller general of the united states.--
(A) In general.--Not later than 3 years after the
date of the enactment of this Act, the Comptroller
General of the United States shall submit to Congress a
report on the implementation of this section and the
effectiveness of the Veterans Justice Outreach Program.
(B) Contents.--The report required by subparagraph
(A) shall include the following:
(i) An assessment of whether the Secretary
has fulfilled the Secretary's obligations under
this section.
(ii) The number of veterans who are served
by Veterans Justice Outreach Specialists hired
under subsection (a)(1), disaggregated by
demographics (including discharge status).
(iii) An identification of any subgroups of
veterans who underutilize services provided
under laws administered by the Secretary,
including an assessment of whether these
veterans have access to Veterans Justice
Outreach Specialists under the Veterans Justice
Outreach Program.
(iv) Such recommendations as the
Comptroller General may have for the Secretary
to improve the effectiveness of the Veterans
Justice Outreach Program.
(e) Definitions.--In this section:
(1) Justice team.--The term ``justice team'' means the
group of individuals, which may include a judge, court
coordinator, prosecutor, public defender, treatment provider,
probation or other law enforcement officer, program mentor, and
Veterans Justice Outreach Specialist, who assist justice-
involved veterans in a veterans treatment court or other
veteran-focused court.
(2) Justice-involved veteran.--The term ``justice-involved
veteran'' means a veteran with active, ongoing, or recent
contact with some component of a local criminal justice system.
(3) Local criminal justice system.--The term ``local
criminal justice system'' means law enforcement, jails,
prisons, and Federal, State, and local courts.
(4) Veterans justice outreach program.--The term ``Veterans
Justice Outreach Program'' means the program through which the
Department of Veterans Affairs identifies justice-involved
veterans and provides such veterans with access to Department
services.
(5) Veterans justice outreach specialist.--The term
``Veterans Justice Outreach Specialist'' means an employee of
the Department of Veterans Affairs who serves as a liaison
between the Department and the local criminal justice system on
behalf of a justice-involved veteran.
(6) Veterans treatment court.--The term ``veterans
treatment court'' means a State or local court that is
participating in the veterans treatment court program (as
defined in section 2991(i)(1) of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3797aa(i)(1))).
Subtitle G--Peer Support Counseling Program for Women Veterans
SEC. 8061. 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 H--Treating Barriers to Prosperity
SEC. 8071. SHORT TITLE.
This subtitle may be cited as the ``Treating Barriers to Prosperity
Act of 2018''.
SEC. 8072. 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 I--Supporting Grandparents Raising Grandchildren
SEC. 8081. SHORT TITLE.
This subtitle may be cited as the ``Supporting Grandparents Raising
Grandchildren Act''.
SEC. 8082. FINDINGS.
Congress finds the following:
(1) More than 2,500,000 grandparents in the United States
are the primary caretaker of their grandchildren, and experts
report that such numbers are increasing as the opioid epidemic
expands.
(2) Between 2009 and 2016, the incidence of parental
alcohol or other drug use as a contributing factor for
children's out-of-home placement rose from 25.4 to 37.4
percent.
(3) When children cannot remain safely with their parents,
placement with relatives is preferred over placement in foster
care with nonrelatives because placement with relatives
provides stability for children and helps them maintain family
connections.
(4) The number of foster children placed with a grandparent
or other relative increased from 24 percent in 2006 to 32
percent in 2016, according to data from the Department of
Health and Human Services.
(5) Grandparents' lives are enhanced by caring for their
grandchildren; the overwhelming majority of grandparents report
experiencing significant benefits in serving as their
grandchildren's primary caregivers.
(6) Providing full-time care to their grandchildren may
decrease grandparents' ability to address their own physical
and mental health needs and personal well-being.
(7) Grandparents would benefit from better coordination and
dissemination of information and resources available to support
them in their caregiving responsibilities.
SEC. 8083. ADVISORY COUNCIL TO SUPPORT GRANDPARENTS RAISING
GRANDCHILDREN.
(a) Establishment.--There is established an Advisory Council to
Support Grandparents Raising Grandchildren.
(b) Membership.--
(1) In general.--The Advisory Council shall be composed of
the following members, or their designee:
(A) The Secretary of Health and Human Services.
(B) The Secretary of Education.
(C) The Administrator of the Administration for
Community Living.
(D) The Director of the Centers for Disease Control
and Prevention.
(E) The Assistant Secretary for Mental Health and
Substance Use.
(F) The Assistant Secretary for the Administration
for Children and Families.
(G) A grandparent raising a grandchild.
(H) An older relative caregiver of children.
(I) As appropriate, the head of other Federal
departments, or agencies, identified by the Secretary
of Health and Human Services as having
responsibilities, or administering programs, relating
to current issues affecting grandparents or other older
relatives raising children.
(2) Lead agency.--The Department of Health and Human
Services shall be the lead agency for the Advisory Council.
(c) Duties.--
(1) In general.--
(A) Information.--The Advisory Council shall
identify, promote, coordinate, and disseminate to the
public information, resources, and the best practices
available to help grandparents and other older
relatives--
(i) meet the health, educational,
nutritional, and other needs of the children in
their care; and
(ii) maintain their own physical and mental
health and emotional well-being.
(B) Opioids.--In carrying out the duties described
in subparagraph (A), the Advisory Council shall
consider the needs of those affected by the opioid
crisis.
(C) Native americans.--In carrying out the duties
described in subparagraph (A), the Advisory Council
shall consider the needs of members of Native American
tribes.
(2) Report.--
(A) In general.--Not later than 180 days after the
date of enactment of this Act, the Advisory Council
shall submit a report to--
(i) the appropriate committees;
(ii) the State agencies that are
responsible for carrying out family caregiver
programs; and
(iii) the public online in an accessible
format.
(B) Report format.--The report shall include--
(i) best practices, resources, and other
useful information for grandparents and other
older relatives raising children identified
under paragraph (1)(A) including, if
applicable, any information related to the
needs of children who have been impacted by the
opioid epidemic;
(ii) an identification of any gaps in items
under clause (i); and
(iii) where applicable, identification of
any additional Federal legislative authority
necessary to implement the activities described
in clause (i) and (ii).
(3) Follow-up report.--Not later than 2 years after the
date on which the report required under paragraph (2)(A) is
submitted, the Advisory Council shall submit a follow-up report
that includes the information identified in paragraph (2)(B)
to--
(A) the appropriate committees;
(B) the State agencies that are responsible for
carrying out family caregiver programs; and
(C) the public online in an accessible format.
(4) Public input.--
(A) In general.--The Advisory Council shall
establish a process for public input to inform the
development of, and provide updates to, the best
practices, resources, and other information described
in paragraph (1) that shall include--
(i) outreach to States, local entities, and
organizations that provide information to, or
support for, grandparents or other older
relatives raising children; and
(ii) outreach to grandparents and other
older relatives with experience raising
children.
(B) Nature of outreach.--Such outreach shall ask
individuals to provide input on--
(i) information, resources, and best
practices available, including identification
of any gaps and unmet needs; and
(ii) recommendations that would help
grandparents and other older relatives better
meet the health, educational, nutritional, and
other needs of the children in their care, as
well as maintain their own physical and mental
health and emotional well-being.
(d) FACA.--The Advisory Council shall be exempt from the
requirements of the Federal Advisory Committee Act (5 U.S.C. App.).
(e) Funding.--No additional funds are authorized to be appropriated
to carry out this subtitle.
(f) Sunset.--The Advisory Council shall terminate on the date that
is 3 years after the date of enactment of this Act.
SEC. 8084. DEFINITIONS.
In this subtitle:
(1) Advisory council.--In this subtitle, the term
``Advisory Council'' means the Advisory Council to Support
Grandparents Raising Grandchildren that is established under
section 8083.
(2) Appropriate committees.--In this subtitle, the term
``appropriate committees'' means the following:
(A) The Special Committee on Aging of the Senate.
(B) The Committee on Health, Education, Labor, and
Pensions of the Senate.
(C) The Committee on Education and the Workforce of
the House of Representatives.
(D) The Committee on Energy and Commerce of the
House of Representatives.
Subtitle J--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''.
TITLE IX--SITSA ACT
SEC. 9001. SHORT TITLE.
This title may be cited as the ``Stop the Importation and
Trafficking of Synthetic Analogues Act of 2017'' or the ``SITSA Act''.
SEC. 9002. ESTABLISHMENT OF SCHEDULE A.
Section 202 of the Controlled Substances Act (21 U.S.C. 812) is
amended--
(1) in subsection (a), by striking ``five schedules of
controlled substances, to be known as schedules I, II, III, IV,
and V'' and inserting ``six schedules of controlled substances,
to be known as schedules I, II, III, IV, V, and A'';
(2) in subsection (b), by adding at the end the following:
``(6) Schedule A.--
``(A) In general.--The drug or substance--
``(i) has--
``(I) a chemical structure that is
substantially similar to the chemical structure
of a controlled substance in schedule I, II,
III, IV, or V; and
``(II) an actual or predicted stimulant,
depressant, or hallucinogenic effect on the
central nervous system that is substantially
similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the
central nervous system of a controlled
substance in schedule I, II, III, IV, or V; and
``(ii) is not--
``(I) listed or otherwise included in any
other schedule in this section or by regulation
of the Attorney General; and
``(II) with respect to a particular person,
subject to an exemption that is in effect for
investigational use, for that person, under
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) to the extent
conduct with respect to such substance is
pursuant to such exemption.
``(B) Predicted stimulant, depressant, or hallucinogenic
effect.--For purpose of this paragraph, a predicted stimulant,
depressant, or hallucinogenic effect on the central nervous
system may be based on--
``(i) the chemical structure and--
``(I) the structure activity relationships;
or
``(II) binding receptor assays and other
relevant scientific information about the
substance;
``(ii)(I) the current or relative potential for
abuse of the substance; and
``(II) the clandestine importation, manufacture, or
distribution, or diversion from legitimate channels, of
the substance; or
``(iii) the capacity of the substance to cause a
state of dependence, including physical or
psychological dependence that is similar to or greater
than that of a controlled substance in schedule I, II,
III, IV, or V.''; and
(3) in subsection (c), in the matter preceding schedule I,
by striking ``IV, and V'' and inserting ``IV, V, and A''.
SEC. 9003. TEMPORARY AND PERMANENT SCHEDULING OF SCHEDULE A SUBSTANCES.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by adding at the end the following:
``(k) Temporary and Permanent Scheduling of Schedule A
Substances.--
``(1) The Attorney General may issue a temporary order
adding a drug or substance to schedule A if the Attorney
General finds that--
``(A) the drug or other substance satisfies the
criteria for being considered a schedule A substance;
and
``(B) adding such drug or substance to schedule A
will assist in preventing abuse of the drug or other
substance.
``(2) A temporary scheduling order issued under paragraph
(1) shall not take effect until 30 days after the date of the
publication by the Attorney General of a notice in the Federal
Register of the intention to issue such order and the grounds
upon which such order is to be issued. The temporary scheduling
order shall expire not later than 5 years after the date it
becomes effective, except that the Attorney General may, during
the pendency of proceedings under paragraph (5), extend the
temporary scheduling order for up to 180 days.
``(3) A temporary scheduling order issued under paragraph
(1) shall be vacated upon the issuance of a permanent order
issued under paragraph (5) with regard to the same substance,
or upon the subsequent issuance of any scheduling order under
this section.
``(4) A temporary scheduling order issued under paragraph
(1) shall not be subject to judicial review.
``(5)(A) Beginning no earlier than 3 years after issuing an
order temporarily scheduling a drug or other substance under
this subsection, the Attorney General may, by rule, issue a
permanent order adding a drug or other substance to schedule A
if such drug or substance satisfies the criteria for being
considered a controlled substance in schedule A under this
subsection, except as provided in subparagraph (B).
``(B) If the Secretary has determined, based on relevant
scientific studies and necessary data requested by the
Secretary and gathered by the Attorney General, that a drug or
other substance that has been temporarily placed in schedule A
does not have sufficient potential for abuse to warrant control
in any schedule, and so advises the Attorney General in
writing, the Attorney General may not issue a permanent
scheduling order under subparagraph (A) and shall, within 30
days of receiving the Secretary's advice issue an order
immediately terminating the temporary scheduling order.
``(6) Before initiating proceedings under paragraph (1),
the Attorney General shall transmit notice of a temporary order
proposed to be issued to the Secretary of Health and Human
Services. In issuing an order under paragraph (1), the Attorney
General shall take into consideration any comments submitted by
the Secretary of Health and Human Services in response to a
notice transmitted pursuant to this paragraph.
``(7) On the date of the publication of a notice in the
Federal Register pursuant to paragraph (2), the Attorney
General shall transmit the same notice to Congress. The
temporary scheduling order shall take effect according to
paragraph (2), except that the temporary scheduling order may
be disapproved by an Act of Congress within 180 days from the
date of publication of the notice in the Federal Register.''.
SEC. 9004. PENALTIES.
(a) Controlled Substances Act.--The Controlled Substances Act (21
U.S.C. 801 et seq.) is amended--
(1) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding
at the end the following:
``(F)(i) In the case of any controlled substance in schedule A,
such person shall be sentenced to a term of imprisonment of not more
than 10 years and if death or serious bodily injury results from the
use of such substance shall be sentenced to a term of imprisonment of
not more than 15 years, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18, United States
Code, or $500,000 if the defendant is an individual or $2.5 million if
the defendant is other than an individual, or both.
``(ii) If any person commits such a violation after a prior
conviction for a felony drug offense has become final, such person
shall be sentenced to a term of imprisonment of not more than 20 years
and if death or serious bodily injury results from the use of such
substance shall be sentenced to a term of imprisonment of not more than
30 years, a fine not to exceed the greater of twice that authorized in
accordance with the provisions of title 18, United States Code, or $1
million if the defendant is an individual or $5 million if the
defendant is other than an individual, or both.
``(iii) Any sentence imposing a term of imprisonment under this
subparagraph shall, in the absence of such a prior conviction, impose a
term of supervised release of not less than 2 years in addition to such
term of imprisonment and shall, if there was such a prior conviction,
impose a term of supervised release of not less than 4 years in
addition to such term of imprisonment.'';
(2) in section 403(a) (21 U.S.C. 843(a))--
(A) in paragraph (8), by striking ``or'' at the
end;
(B) in paragraph (9), by striking the period at the
end and inserting ``; or''; and
(C) by inserting after paragraph (9) the following:
``(10) to export a substance in violation of the controlled
substance laws of the country to which the substance is
exported.''; and
(3) in section 404 (21 U.S.C. 844), by inserting after
subsection (a) the following:
``(b) A person shall not be subject to a criminal or civil penalty
under this title or under any other Federal law solely for possession
of a schedule A controlled substance.''.
(b) Controlled Substances Import and Export Act.--Section 1010(b)
of the Controlled Substances Import and Export Act (21 U.S.C. 960(b))
is amended by adding at the end the following:
``(8) In the case of a violation under subsection (a) involving a
controlled substance in schedule A, the person committing such
violation shall be sentenced to a term of imprisonment of not more than
20 years and if death or serious bodily injury results from the use of
such substance shall be sentenced to a term of imprisonment of not more
than life, a fine not to exceed the greater of that authorized in
accordance with the provisions of title 18, United States Code, or $1
million if the defendant is an individual or $5 million if the
defendant is other than an individual, or both. If any person commits
such a violation after a prior conviction for a felony drug offense has
become final, such person shall be sentenced to a term of imprisonment
of not more than 30 years and if death or serious bodily injury results
from the use of such substance shall be sentenced to not more than life
imprisonment, a fine not to exceed the greater of twice that authorized
in accordance with the provisions of title 18, United States Code, or
$2 million if the defendant is an individual or $10 million if the
defendant is other than an individual, or both. Notwithstanding section
3583 of title 18, United States Code, any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a prior
conviction, impose a term of supervised release of not less than 3
years in addition to such term of imprisonment and shall, if there was
such a prior conviction, impose a term of supervised release of not
less than 6 years in addition to such term of imprisonment.
Notwithstanding the prior sentence, and notwithstanding any other
provision of law, the court shall not place on probation or suspend the
sentence of any person sentenced under the provisions of this paragraph
which provide for a mandatory term of imprisonment if death or serious
bodily injury results.''.
SEC. 9005. FALSE LABELING OF SCHEDULE A CONTROLLED SUBSTANCES.
(a) In General.--Section 305 of the Controlled Substances Act (21
U.S.C. 825) is amended by adding at the end the following:
``(f) False Labeling of Schedule A Controlled Substances.--
``(1) It shall be unlawful to import, export, manufacture,
distribute, dispense, or possess with intent to manufacture,
distribute, or dispense, a schedule A substance or product
containing a schedule A substance, unless the substance or
product bears a label clearly identifying a schedule A
substance or product containing a schedule A substance by the
nomenclature used by the International Union of Pure and
Applied Chemistry (IUPAC).
``(2)(A) A product described in subparagraph (B) is exempt
from the International Union of Pure and Applied Chemistry
nomenclature requirement of this subsection if such product is
labeled in the manner required under the Federal Food, Drug,
and Cosmetic Act.
``(B) A product is described in this subparagraph if the
product--
``(i) is the subject of an approved application as
described in section 505(b) or (j) of the Federal Food,
Drug, and Cosmetic Act; or
``(ii) is exempt from the provisions of section 505
of such Act relating to new drugs because--
``(I) it is intended solely for
investigational use as described in section
505(i) of such Act; and
``(II) such product is being used
exclusively for purposes of a clinical trial
that is the subject of an effective
investigational new drug application.''.
(b) Penalties.--Section 402 of the Controlled Substances Act (21
U.S.C. 842) is amended--
(1) in subsection (a)(16), by inserting ``or subsection
(f)'' after ``subsection (e)''; and
(2) in subsection (c)(1)(D), by inserting ``or a schedule A
substance'' after ``anabolic steroid''.
SEC. 9006. REGISTRATION REQUIREMENTS FOR HANDLERS OF SCHEDULE A
SUBSTANCES.
(a) Controlled Substances Act.--Section 303 of the Controlled
Substances Act (21 U.S.C. 823) is amended by adding at the end the
following:
``(k)(1) The Attorney General shall register an applicant to
manufacture schedule A substances if--
``(A) the applicant demonstrates that the schedule A
substances will be used for research, analytical, or industrial
purposes approved by the Attorney General; and
``(B) the Attorney General determines that such
registration is consistent with the public interest and with
the United States obligations under international treaties,
conventions, or protocols in effect on the date of enactment of
this subsection.
``(2) In determining the public interest under paragraph (1)(B),
the Attorney General shall consider--
``(A) maintenance of effective controls against diversion
of particular controlled substances and any controlled
substance in schedule A compounded therefrom into other than
legitimate medical, scientific, research, or industrial
channels, by limiting the importation and bulk manufacture of
such controlled substances to a number of establishments which
can produce an adequate and uninterrupted supply of these
substances under adequately competitive conditions for
legitimate medical, scientific, research, and industrial
purposes;
``(B) compliance with applicable State and local law;
``(C) promotion of technical advances in the art of
manufacturing substances described in subparagraph (A) and the
development of new substances;
``(D) prior conviction record of applicant under Federal
and State laws relating to the manufacture, distribution, or
dispensing of substances described in paragraph (A);
``(E) past experience in the manufacture of controlled
substances, and the existence in the establishment of effective
control against diversion; and
``(F) such other factors as may be relevant to and
consistent with the public health and safety.
``(3) If an applicant is registered to manufacture controlled
substances in schedule I or II under subsection (a), the applicant
shall not be required to apply for a separate registration under this
subsection.
``(l)(1) The Attorney General shall register an applicant to
distribute schedule A substances--
``(A) if the applicant demonstrates that the schedule A
substances will be used for research, analytical, or industrial
purposes approved by the Attorney General; and
``(B) unless the Attorney General determines that the
issuance of such registration is inconsistent with the public
interest.
``(2) In determining the public interest under paragraph (1)(B),
the Attorney General shall consider--
``(A) maintenance of effective control against diversion of
particular controlled substances into other than legitimate
medical, scientific, and industrial channels;
``(B) compliance with applicable State and local law;
``(C) prior conviction record of applicant under Federal or
State laws relating to the manufacture, distribution, or
dispensing of substances described in subparagraph (A);
``(D) past experience in the distribution of controlled
substances; and
``(E) such other factors as may be relevant to and
consistent with the public health and safety.
``(3) If an applicant is registered to distribute a controlled
substance in schedule I or II under subsection (b), the applicant shall
not be required to apply for a separate registration under this
subsection.
``(m)(1)(A) Not later than 90 days after the date on which a
substance is placed in schedule A, any practitioner who was engaged in
research on the substance before the placement of the substance in
schedule A and any manufacturer or distributor who was handling the
substance before the placement of the substance in schedule A shall
register with the Attorney General.
``(B)(i) If an applicant described in subparagraph (A) is
registered pursuant to subsection (f) to conduct research with a
controlled substance in schedule I or II on the date on which another
substance is placed in schedule A, the applicant may, subject to clause
(iii), conduct research with that other controlled substance in
schedule A while the application for registration pursuant to
subparagraph (A) is pending.
``(ii) If an applicant described in subparagraph (A) is registered
pursuant to subsection (f) as described in clause (i) to conduct
research with a controlled substance in schedule III, IV, or V on the
date on which another substance is placed in schedule A, the applicant
may, subject to clause (iii), conduct research with that other
controlled substance in schedule A while the application for
registration pursuant to subparagraph (A) is pending, provided the
substance for which the applicant is registered to conduct research is
in the same schedule as, or a less-restricted schedule than, the
controlled substance whose similarity in chemical structure and actual
or predicted effect to the controlled substance in schedule A formed
the basis for placement of the substance in schedule A, as set forth in
the order published in the Federal Register placing the substance in
schedule A.
``(iii) The permission to conduct research pursuant to clause (i)
or clause (ii) is conditional on the applicant's complying with the
registration and other requirements for controlled substances in
schedule A.
``(iv) This subparagraph does not apply to applicants registered
pursuant to subsection (f) whose authorization to conduct research with
any controlled substances is limited to doing so as a coincident
activity pursuant to applicable regulations of the Attorney General.
``(2)(A) Not later than 60 days after the date on which the
Attorney General receives an application for registration to conduct
research on a schedule A substance, the Attorney General shall--
``(i) grant, or initiate proceedings under section 304(c)
to deny, the application; or
``(ii) request supplemental information from the applicant.
``(B) Not later than 30 days after the date on which the Attorney
General receives supplemental information requested under subparagraph
(A)(ii) in connection with an application described in subparagraph
(A), the Attorney General shall grant or deny the application.
``(n)(1) The Attorney General shall register a scientific
investigator or a qualified research institution to conduct research
with controlled substances in schedule A in accordance with this
subsection. In evaluating applications for such registration, the
Attorney General shall apply the criteria set forth in subsection (f)
of this section that apply to practitioners seeking a registration to
conduct research with a schedule I controlled substance, except that
the applicant shall not be required to submit a research protocol.
``(2) If the applicant is not currently registered under subsection
(f) to conduct research with a schedule I controlled substance, the
Attorney General shall refer the application to the Secretary, who
shall determine whether the applicant will be engaged in bona fide
research and is qualified to conduct such research. The 60-day period
under subsection (m)(2)(A) shall be tolled during the period beginning
on the date on which the Attorney General refers an application to the
Secretary under this paragraph, and ending on the date on which the
Secretary submits a determination related to such referral to the
Attorney General.
``(3) An applicant who meets the criteria under subsection
(m)(1)(B) with respect to a particular schedule A controlled substance
shall be considered qualified to conduct research with that substance.
The Attorney General shall modify such applicant's registration to
include such schedule A controlled substance in accordance with this
paragraph. The applicant shall notify the Attorney General of his
intent to conduct research with a controlled substance in schedule A.
Upon receiving such notification, the Attorney General shall modify the
practitioner's existing registration to authorize research with
schedule A controlled substances, unless the Attorney General
determines that the registration modification would be inconsistent
with the public interest based on the criteria of subsection (f).
``(4) Registrations issued under this subsection to a qualified
research institution will apply to all agents and employees of that
institution acting within the scope of their professional practice.
``(5) At least 30 days prior to conducting any research with a
controlled substance in schedule A, the registrant shall provide the
Attorney General with written notification of the following:
``(A) The name of and drug code for each substance.
``(B) The name of each individual with access to each
substance.
``(C) The amount of each substance.
``(D) Other similar information the Attorney General may
require.
``(6) The quantity of a schedule A controlled substance possessed
by a person registered under this subsection shall be appropriate for
the research being conducted, subject to the additional limitations set
forth in this paragraph. To reduce the risk of diversion, the Attorney
General may establish limitations on the quantity of schedule A
controlled substances that may be manufactured or possessed for
purposes of research under this subsection and shall publish such
limitations on the website of the Drug Enforcement Administration. A
person registered under this subsection may, based on legitimate
research needs, apply to the Attorney General to manufacture or possess
an amount greater than that so specified by the Attorney General. The
Attorney General shall specify the manner in which such applications
shall be submitted. The Attorney General shall act on an application
filed under this subparagraph within 30 days of receipt of such
application. If the Attorney General fails to act within 30 days, the
registrant shall be allowed to manufacture and possess up to the amount
requested. The Attorney General shall have the authority to reverse the
increase for cause.
``(7) The Attorney General shall by regulation specify the manner
in which applications for registration under this subsection shall be
submitted.
``(8) Registrants authorized under this subsection may manufacture
and possess schedule A controlled substances up to the approved amounts
only for use in their own research setting or institution.
Manufacturing for use in any other setting or institution shall require
a manufacturer's registration under section 303(a).''.
(b) Controlled Substances Import and Export Act.--Section 1008 of
the Controlled Substances Import and Export Act (21 U.S.C. 958) is
amended by adding at the end the following:
``(j)(1) The Attorney General shall register an applicant to import
or export a schedule A substance if--
``(A) the applicant demonstrates that the schedule A
substances will be used for research, analytical, or industrial
purposes approved by the Attorney General; and
``(B) the Attorney General determines that such
registration is consistent with the public interest and with
the United States obligations under international treaties,
conventions, or protocols in effect on the date of enactment of
this subsection.
``(2) In determining the public interest under paragraph (1)(B),
the Attorney General shall consider the factors described in
subparagraphs (A) through (F) of section 303(k)(2).
``(3) If an applicant is registered to import or export a
controlled substance in schedule I or II under subsection (a), the
applicant shall not be required to apply for a separate registration
under this subsection.''.
SEC. 9007. ADDITIONAL CONFORMING AMENDMENTS.
(a) Controlled Substances Act.--The Controlled Substances Act (21
U.S.C. 801 et seq.) is amended--
(1) in section 303(c) (21 U.S.C. 823(c))--
(A) by striking ``subsections (a) and (b)'' and
inserting ``subsection (a), (b), (k), or (l)''; and
(B) by striking ``schedule I or II'' and inserting
``schedule I, II, or A'';
(2) in section 306 (21 U.S.C. 826)--
(A) in subsection (a), in the first sentence, by
striking ``schedules I and II'' and inserting
``schedules I, II, and A'';
(B) in subsection (b), in the second sentence, by
striking ``schedule I or II'' and inserting ``schedule
I, II, or A'';
(C) in subsection (c), in the first sentence, by
striking ``schedules I and II'' and inserting
``schedules I, II, and A'';
(D) in subsection (d), in the first sentence, by
striking ``schedule I or II'' and inserting ``schedule
I, II, or A'';
(E) in subsection (e), in the first sentence, by
striking ``schedule I or II'' and inserting ``schedule
I, II, or A''; and
(F) in subsection (f), in the first sentence, by
striking ``schedules I and II'' and inserting
``schedules I, II, and A'';
(3) in section 308(a) (21 U.S.C. 828(a)), by striking
``schedule I or II'' and inserting ``schedule I, II, or A'';
(4) in section 402(b) (21 U.S.C. 842(b)), in the matter
preceding paragraph (1), by striking ``schedule I or II'' and
inserting ``schedule I, II, or A'';
(5) in section 403(a)(1) (21 U.S.C. 843(a)(1)), by striking
``schedule I or II'' and inserting ``schedule I, II, or A'';
and
(6) in section 511(f) (21 U.S.C. 881(f)), by striking
``schedule I or II'' each place it appears and inserting
``schedule I, II, or A''.
(b) Controlled Substances Import Export Act.--The Controlled
Substances Import and Export Act (21 U.S.C. 951 et seq.) is amended--
(1) in section 1002(a) (21 U.S.C. 952(a))--
(A) in the matter preceding paragraph (1), by
striking ``schedule I or II'' and inserting ``schedule
I, II, or A''; and
(B) in paragraph (2), by striking ``schedule I or
II'' and inserting ``schedule I, II, or A'';
(2) in section 1003 (21 U.S.C. 953)--
(A) in subsection (c), in the matter preceding
paragraph (1), by striking ``schedule I or II'' and
inserting ``schedule I, II, or A''; and
(B) in subsection (d), by striking ``schedule I or
II'' and inserting ``schedule I, II, or A'';
(3) in section 1004(1) (21 U.S.C. 954(1)), by striking
``schedule I'' and inserting ``schedule I or A'';
(4) in section 1005 (21 U.S.C. 955), by striking ``schedule
I or II'' and inserting ``schedule I, II, or A''; and
(5) in section 1009(a) (21 U.S.C. 959(a)), by striking
``schedule I or II'' and inserting ``schedule I, II, or A''.
SEC. 9008. CONTROLLED SUBSTANCE ANALOGUES.
Section 102 of the Controlled Substances Act (21 U.S.C. 802) is
amended--
(1) in paragraph (6), by striking ``or V'' and inserting
``V, or A'';
(2) in paragraph (14)--
(A) by striking ``schedule I(c) and'' and inserting
``schedule I(c), schedule A, and''; and
(B) by striking ``schedule I(c),'' and inserting
``schedule I(c) and schedule A,''; and
(3) in paragraph (32)(A), by striking ``(32)(A)'' and all
that follows through clause (iii) and inserting the following:
``(32)(A) Except as provided in subparagraph (C), the term
`controlled substance analogue' means a substance whose chemical
structure is substantially similar to the chemical structure of a
controlled substance in schedule I or II--
``(i) which has a stimulant, depressant, or hallucinogenic
effect on the central nervous system that is substantially
similar to or greater than the stimulant, depressant, or
hallucinogenic effect on the central nervous system of a
controlled substance in schedule I or II; or
``(ii) with respect to a particular person, which such
person represents or intends to have a stimulant, depressant,
or hallucinogenic effect on the central nervous system that is
substantially similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the central nervous
system of a controlled substance in schedule I or II.''.
SEC. 9009. RULES OF CONSTRUCTION.
Nothing in this title, or the amendments made by this title, may be
construed to limit--
(1) the prosecution of offenses involving controlled
substance analogues under the Controlled Substances Act (21
U.S.C. 801 et seq.); or
(2) the authority of the Attorney General to temporarily or
permanently schedule, reschedule, or decontrol controlled
substances under provisions of section 201 of the Controlled
Substances Act (21 U.S.C. 811) that are in effect on the day
before the date of enactment of this title.
SEC. 9010. STUDY BY COMPTROLLER GENERAL.
Not later than 2 years after the date of enactment of this title,
the Comptroller General of the United States shall complete a study and
submit a report to the Committees on the Judiciary of the House of
Representatives and of the Senate regarding the costs associated with
the amendments made by section 4, including--
(1) the annual amounts expended by Federal agencies in
carrying out the amendments;
(2) the costs associated with arrests, trials, convictions,
imprisonment, or imposition of other sanctions in accordance
with the amendments; and
(3) the impact (including the fiscal impact) of the
amendments on existing correctional facilities and the
likelihood that those amendments will create a need for
additional capacity for housing prisoners.
SEC. 9011. REPORT ON CONTROLLED SUBSTANCE ANALOGUES SOLD BY MEANS OF
THE INTERNET.
Not later than 1 year after the date of the enactment of this
title, and annually thereafter, the Administrator of the Drug
Enforcement Administration shall make publicly available on the website
of the Drug Enforcement Administration a report on, for the previous
year, the lawful and unlawful sale of controlled substance analogues
(as defined in section 102 of the Controlled Substances Act (21 U.S.C.
802)) by means of the Internet, including the following information:
(1) The types of controlled substance analogues that were
sold, and the number of sales for each such substance.
(2) The name of each person, entity, or Internet site,
whether in the United States or abroad, that knowingly or
intentionally delivers, distributes, or dispenses, or offers or
attempts to deliver, distribute, or dispense, a controlled
substance analogue by means of the Internet, whether lawfully
or unlawfully.
(3) An estimate of the total revenue for all of the vendors
described in paragraph (2) for all of the sales described in
paragraph (1).
SEC. 9012. 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.''.
TITLE X--THRIVE ACT
SEC. 10001. SHORT TITLE.
This title may be cited as the ``Transitional Housing for Recovery
in Viable Environments Demonstration Program Act'' or the ``THRIVE
Act''.
SEC. 10002. DEMONSTRATION PROGRAM TO STUDY THE IMPACT OF USING RENTAL
VOUCHERS FOR SUPPORTIVE HOUSING FOR INDIVIDUALS
RECOVERING FROM OPIOID USE DISORDERS OR OTHER SUBSTANCE
USE DISORDERS.
Section 8(o) of the United States Housing Act of 1937 (42 U.S.C.
1437f(o)) is amended by adding at the end the following new paragraph:
``(21) Rental voucher demonstration program for supportive
housing for individuals recovering from opioid use disorders or
other substance use disorders.--
``(A) Establishment.--The Secretary shall establish
a demonstration program under which the Secretary shall
set aside, allocate, and distribute directly to
eligible entities, from amounts made available for
rental assistance under this subsection, the amounts
specified in subparagraph (B) for an eligible entity to
provide a voucher for such assistance to a covered
individual through a supportive housing program that
provides treatment for opioid use disorders or other
substance use disorders (as applicable), coordination
with workforce development providers, and such
assistance, as determined by the entity.
``(B) Amount.--The amount specified in this
subparagraph is, for fiscal year 2019, the amount
necessary to provide the lesser of--
``(i) 0.5 percent of the total number of
vouchers renewed under this subsection during
the fiscal year ending immediately before the
date of the enactment of this paragraph; or
``(ii) 10,000 vouchers.
``(C) Criteria for eligible entities.--An eligible
entity shall--
``(i) provide an evidence-based treatment
program and demonstrate the ability to
coordinate with workforce development providers
for individuals recovering from an opioid use
disorder or other substance use disorder, as
applicable, that meet standards established by
the Secretary; and
``(ii) demonstrate prior experience
administering rental assistance vouchers,
demonstrate prior experience administering
supportive housing programs under the McKinney-
Vento Homeless Act, or demonstrate a
partnership with a public housing agency or a
housing program of a State, unit of local
government, or Indian tribe (as such term is
defined in section 4 of the Native American
Housing and Self-Determination Act of 1996 (25
U.S.C. 4103)) that ensures effective
administration of rental assistance vouchers.
``(D) Application.--To receive a rental assistance
voucher under this paragraph, an eligible entity shall
submit an application to the Secretary that shall
include--
``(i) a description of the terms of
treatment program, coordination with workforce
development providers, and rental assistance to
be provided to a covered individual, and
assurances that such description shall be
communicated to covered individuals that
receive vouchers pursuant to the demonstration
program established under this paragraph;
``(ii) a transitional plan that begins on
the date on which a covered individual
completes the treatment program of the eligible
entity that includes information on additional
treatment, coordination with workforce
development opportunities, and housing
resources and services available to such
covered individual; and
``(iii) evidence sufficient to demonstrate
that the local government having jurisdiction
over the location of any supportive housing
facility to be used by the eligible entity in
connection with the demonstration program under
this paragraph permits such facilities in such
location.
``(E) Selection.--In selecting eligible entities to
receive rental assistance vouchers under this
paragraph, the Secretary shall--
``(i) ensure that such eligible entities--
``(I) are diverse;
``(II) represent an appropriate
balance of eligible entities located in
urban and rural areas, including tribal
communities;
``(III) have adequate resources for
treatment, recovery, and supportive
services;
``(IV) fully comply with the Fair
Housing Act (42 U.S.C. 3601 et seq.)
and the Civil Rights Act of 1964 (42
U.S.C. 2000a et seq.);
``(V) appropriately reflect the
impact that opioids are having in
tribal communities; and
``(VI) provide supportive and
transitional housing programs in
diverse geographic regions with high
rates of mortality due to opioid use
disorders or other substance use
disorders, as applicable, based on data
of the Centers for Disease Control and
Prevention; and
``(ii) consider, in consultation with the
Secretary of Health and Human Services and the
Secretary of Labor--
``(I) the success of each recipient
eligible entity at helping individuals
complete the treatment program of the
eligible entity and refrain from
illicit opioid or other substance
usage, as applicable;
``(II) the coordination with
workforce development providers by the
eligible entity;
``(III) the percentage of
participants in unsubsidized employment
during the second and fourth calendar
quarter after exit from the program;
and
``(IV) the percentage of
participants in the treatment program
of the eligible entity that do not
relapse into opioid or other substance
usage, as applicable.
``(F) Reissuance of voucher.--Upon termination of
the provision of rental assistance through a voucher to
a covered individual, the eligible entity that
initially offered such voucher may use such voucher to
provide rental assistance to another covered
individual.
``(G) Duration.--The Secretary shall not make
rental assistance available under this paragraph after
the expiration of the 5-year period beginning on the
date of the enactment of this paragraph.
``(H) Waivers.--The Secretary may, through
publication of a notice in the Federal Register, waive
or specify alternative requirements for any provision
of statue or regulation governing the use of vouchers
under this subsection (except for requirements relating
to fair housing, nondiscrimination, labor standards, or
the environment) upon a finding by the Secretary that
such waiver or alternative requirement is necessary for
the purposes of this paragraph.
``(I) Reports.--
``(i) By the eligible entity.--An eligible
entity that receives a rental assistance
voucher under this paragraph shall submit to
the Secretary--
``(I) annually, the transitional
plan described in subparagraph (D)(ii)
and information on each covered
individual's housing upon termination
of the provision of rental assistance
through a voucher to such covered
individual in a manner that protects
the privacy of such covered individual;
and
``(II) not later than 4 years after
the date of the enactment of this
paragraph, a plan describing the
treatment and housing options for any
covered individual assisted by such
voucher who will not have completed the
program before the day that is 5 years
after such date of enactment.
``(ii) By the secretary.--The Secretary
shall submit to Congress a report that analyzes
the impact of rental assistance provided under
this paragraph--
``(I) not later than 2 years after
the date of the enactment of this
paragraph; and
``(II) not later than 4 years after
the date of the enactment of this
paragraph.
``(J) Definitions.--In this paragraph:
``(i) Eligible entity.--The term `eligible
entity' means a tribally designated housing
entity (as such term is defined in section 4 of
the Native American Housing and Self-
Determination Act of 1996 (24 U.S.C. 4103)), or
a nonprofit organization, that meets the
criteria described under subparagraph (C).
``(ii) Covered individual.--The term
`covered individual' means an individual
recovering from an opioid use disorder or other
substance use disorder.''.
SEC. 10003. REPEAL OF RENTAL VOUCHER DEMONSTRATION PROGRAM.
Effective the day that is 5 years after the date of the enactment
of this title, paragraph (21) of section 8(o) of the United States
Housing Act of 1937 (42 U.S.C. 1437f(o)), as added by this title, is
repealed.
SEC. 10004. DEMONSTRATION CLOSE-OUT.
An eligible entity that provided vouchers for rental assistance
under paragraph (21) of section 8(o) of the United States Housing Act
of 1937 (42 U.S.C. 1437f(o)), as added by this title, shall return any
such vouchers to the Secretary of Housing and Urban Development not
later than the day that is 5 years after the date of the enactment of
this title for use only for renewals of expiring contracts for such
assistance.
SEC. 10005. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to carry out
the requirements of this title and the amendments made by this title.
Such requirements shall be carried out using amounts otherwise
authorized to be appropriated.
TITLE XI--IMD CARE ACT
SEC. 11001. 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. 11002. MEDICAID STATE PLAN OPTION TO PROVIDE SERVICES FOR CERTAIN
INDIVIDUALS WITH TARGETED SUDS IN INSTITUTIONS FOR MENTAL
DISEASES.
Section 1915 of the Social Security Act (42 U.S.C. 1396n) is
amended by adding at the end the following new subsection:
``(l) State Plan Option To Provide Services for Certain Individuals
in Institutions for Mental Diseases.--
``(1) In general.--With respect to calendar quarters
beginning during the period beginning January 1, 2019, and
ending December 31, 2023, a State may elect, through a State
plan amendment, to, notwithstanding section 1905(a), provide
medical assistance for services furnished in institutions for
mental diseases and for other medically necessary services
furnished to eligible individuals with targeted SUDs, in
accordance with the requirements of this subsection.
``(2) Payments.--
``(A) In general.--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 with a
targeted SUD who is a patient in an 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.
``(B) Clarification.--Payment made under this
paragraph for expenditures under a State plan amendment
under this subsection with respect to services
described in paragraph (1) furnished to an eligible
individual with a targeted SUD shall not affect payment
that would otherwise be made under section 1903(a) for
expenditures under the State plan (or waiver of such
plan) for medical assistance for such individual.
``(3) Information required in state plan amendment.--
``(A) In general.--A State electing to provide
medical assistance pursuant to this subsection shall
include with the submission of the State plan amendment
under paragraph (1) to the Secretary--
``(i) a plan on how the State will improve
access to outpatient care during the period of
the State plan amendment, including a
description of--
``(I) the process by which eligible
individuals with targeted SUDs will
make the transition from receiving
inpatient services in an institution
for mental diseases to appropriate
outpatient care; and
``(II) the process the State will
undertake to ensure eligible
individuals with targeted SUDs are
provided care in the most integrated
setting appropriate to the needs of the
individuals; and
``(ii) a description of how the State plan
amendment ensures an appropriate clinical
screening of eligible individuals with targeted
SUDs, including assessments to determine level
of care and length of stay recommendations
based upon the multidimensional assessment
criteria of the American Society of Addiction
Medicine and to determine the appropriate
setting for such care.
``(B) Report.--Not later than the sooner of
December 31, 2024, or 1 year after the date of the
termination of a State plan amendment under this
subsection, the State shall submit to the Secretary a
report that includes at least--
``(i) the number of eligible individuals
with targeted SUDs who received services
pursuant to such State plan amendment;
``(ii) the length of the stay of each such
individual in an institution for mental
diseases;
``(iii) the type of outpatient treatment,
including medication-assisted treatment, each
such individual received after being discharged
from such institution;
``(iv) the number of eligible individuals
with any co-occuring disorders who received
services pursuant to such State plan amendment
and the co-occuring disorders from which they
suffer; and
``(v) information regarding the effects of
a State plan amendment on access to community
care for individuals suffering from a mental
disease other than substance use disorder.
``(4) Definitions.--In this subsection:
``(A) Eligible individual with a targeted sud.--The
term `eligible individual with a targeted SUD' 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 been diagnosed with at least one
targeted SUD.
``(B) Institution for mental diseases.--The term
`institution for mental diseases' has the meaning given
such term in section 1905(i).
``(C) Opioid prescription pain reliever.--The term
`opioid prescription pain reliever' includes
hydrocodone products, oxycodone products, tramadol
products, codeine products, morphine products, fentanyl
products, buprenorphine products, oxymorphone products,
meperidine products, hydromorphone products, methadone,
and any other prescription pain reliever identified by
the Assistant Secretary for Mental Health and Substance
Use.
``(D) Other medically necessary services.--The term
`other medically necessary services' means, with
respect to an eligible individual with a targeted SUD
who is a patient in an institution for mental diseases,
items and services that are provided to such individual
outside of such institution to the extent that such
items and services would be treated as medical
assistance for such individual if such individual were
not a patient in such institution.
``(E) Targeted sud.--
``(i) In general.--The term `targeted SUD'
means an opioid use disorder or a cocaine use
disorder.
``(ii) Cocaine use disorder.--The term
`cocaine use disorder' means a disorder that
meets the criteria of the Diagnostic and
Statistical Manual of Mental Disorders, 4th
Edition (or a successor edition), for either
dependence or abuse for cocaine, including
cocaine base (commonly referred to as `crack
cocaine').
``(iii) Opioid use disorder.--The term
`opioid use disorder' means a disorder that
meets the criteria of the Diagnostic and
Statistical Manual of Mental Disorders, 4th
Edition (or a successor edition), for heroin
use disorder or pain reliever use disorder
(including with respect to opioid prescription
pain relievers).''.
SEC. 11003. PROMOTING VALUE IN MEDICAID MANAGED CARE.
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)(A) With respect to expenditures described in subparagraph (B)
that are incurred by a State for any fiscal year after fiscal year 2020
(and before fiscal year 2024), in determining the pro rata share to
which the United States is equitably entitled under subsection (d)(3),
the Secretary shall substitute the Federal medical assistance
percentage that applies for such fiscal year to the State under section
1905(b) (without regard to any adjustments to such percentage
applicable under such section or any other provision of law) for the
percentage that applies to such expenditures under section 1905(y).
``(B) Expenditures described in this subparagraph, with respect to
a fiscal year to which subparagraph (A) applies, are expenditures
incurred by a State for payment for medical assistance provided to
individuals described in subclause (VIII) of section 1902(a)(10)(A)(i)
by a managed care entity, or other specified entity (as defined in
subparagraph (D)(iii)), that are treated as remittances because the
State--
``(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
``(I) in the case of a State described in
subparagraph (C), to apply a minimum medical loss ratio
(as defined in subparagraph (D)(ii)) that is at least
85 percent but not greater than the minimum medical
loss ratio (as so defined) that such State applied as
of May 31, 2018; or
``(II) in the case of a State not described in
subparagraph (C), to apply a minimum medical loss ratio
that is equal to 85 percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described in this
subparagraph is a State that as of May 31, 2018, applied a minimum
medical loss ratio (as calculated under subsection (d) of section 438.8
of title 42, Code of Federal Regulations (as in effect on June 1,
2018)) for payment for services provided by entities described in such
subparagraph under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid
managed care organization described in section
1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as calculated
under subsection (d) of section 438.8 of title 42, Code of
Federal Regulations (as in effect on June 1, 2018)) for payment
for services provided by entities described in subparagraph (B)
under the State plan under this title (or a waiver of the
plan).
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined
in section 438.2 of title 42, Code of Federal
Regulations (or any successor regulation); and
``(II) a prepaid ambulatory health plan, as defined
in such section (or any successor regulation).''.
Passed the House of Representatives June 22, 2018.
Attest:
KAREN L. HAAS,
Clerk.
Calendar No. 485
115th CONGRESS
2d Session
H. R. 6
_______________________________________________________________________
AN ACT
To provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes.
_______________________________________________________________________
June 26, 2018
Read the second time and placed on the calendar