[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Engrossed in House (EH)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
115th CONGRESS
  2d Session
                                 H. R. 6

_______________________________________________________________________

                                 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:

                                                                 Clerk.
115th CONGRESS

  2d Session

                                H. R. 6

_______________________________________________________________________

                                 AN ACT

To provide for opioid use disorder prevention, recovery, and treatment, 
                        and for other purposes.