H.R. 6 — Enrolled Amendment (Senate)

In the Senate of the United States, September 17, 2018. Amendment: That the bill from the House of Representatives (H.R. 6) entitled An Act to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes., do pass with the following Strike all after the enacting clause and insert the following: 1. Short title; table of contents (a) Short title This Act may be cited as the Opioid Crisis Response Act of 2018. (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents.TITLE I—Opioid Crisis Response ActSec. 1001. Definitions.Subtitle A—Reauthorization of Cures FundingSec. 1101. State response to the opioid abuse crisis.Subtitle B—Research and InnovationSec. 1201. Advancing cutting-edge research.Sec. 1202. Pain research.Sec. 1203. Report on synthetic drug use.Subtitle C—Medical Products and Controlled Substances SafetySec. 1301. Clarifying FDA regulation of non-addictive pain products.Sec. 1302. Clarifying FDA packaging authorities.Sec. 1303. Strengthening FDA and CBP coordination and capacity.Sec. 1304. Clarifying FDA post-market authorities.Sec. 1305. Restricting entrance of illicit drugs.Sec. 1306. First responder training.Sec. 1307. Disposal of controlled substances of hospice patients.Sec. 1308. GAO study and report on hospice safe drug management.Sec. 1309. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation.Subtitle D—Treatment and RecoverySec. 1401. Comprehensive opioid recovery centers.Sec. 1402. Program to support coordination and continuation of care for drug overdose patients.Sec. 1403. Alternatives to opioids.Sec. 1404. Building communities of recovery.Sec. 1405. Peer support technical assistance center.Sec. 1406. Medication-assisted treatment for recovery from addiction.Sec. 1407. Grant program.Sec. 1408. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders.Sec. 1409. National recovery housing best practices.Sec. 1410. Addressing economic and workforce impacts of the opioid crisis.Sec. 1411. Career Act.Sec. 1412. Pilot program to help individuals in recovery from a substance use disorder become stably housed.Sec. 1413. Youth prevention and recovery.Sec. 1414. Plans of safe care.Sec. 1415. Regulations relating to special registration for telemedicine.Sec. 1416. National Health Service Corps behavioral and mental health professionals providing obligated service in schools and other community-based settings.Sec. 1417. Loan repayment for substance use disorder treatment providers.Sec. 1418. Protecting moms and infants.Sec. 1419. Early interventions for pregnant women and infants.Sec. 1420. Report on investigations regarding parity in mental health and substance use disorder benefits.Subtitle E—PreventionSec. 1501. Study on prescribing limits.Sec. 1502. Programs for health care workforce.Sec. 1503. Education and awareness campaigns.Sec. 1504. Enhanced controlled substance overdoses data collection, analysis, and dissemination.Sec. 1505. Preventing overdoses of controlled substances.Sec. 1506. CDC surveillance and data collection for child, youth, and adult trauma.Sec. 1507. Reauthorization of NASPER.Sec. 1508. Jessie’s law.Sec. 1509. Development and dissemination of model training programs for substance use disorder patient records.Sec. 1510. Communication with families during emergencies.Sec. 1511. Prenatal and postnatal health.Sec. 1512. Surveillance and education regarding infections associated with illicit drug use and other risk factors.Sec. 1513. Task force to develop best practices for trauma-informed identification, referral, and support.Sec. 1514. Grants to improve trauma support services and mental health care for children and youth in educational settings.Sec. 1515. National Child Traumatic Stress Initiative.Sec. 1516. National milestones to measure success in curtailing the opioid crisis.TITLE II—FinanceSec. 2001. Short title.Subtitle A—MedicareSec. 2101. Medicare opioid safety education.Sec. 2102. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders.Sec. 2103. Comprehensive screenings for seniors.Sec. 2104. Every prescription conveyed securely.Sec. 2105. Standardizing electronic prior authorization for safe prescribing.Sec. 2106. Strengthening partnerships to prevent opioid abuse.Sec. 2107. Commit to opioid medical prescriber accountability and safety for seniors.Sec. 2108. Fighting the opioid epidemic with sunshine.Sec. 2109. Demonstration testing coverage of certain services furnished by opioid treatment programs.Sec. 2110. Encouraging appropriate prescribing under Medicare for victims of opioid overdose.Sec. 2111. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries.Sec. 2112. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology.Sec. 2113. Medicare Improvement Fund.Subtitle B—MedicaidSec. 2201. Caring recovery for infants and babies.Sec. 2202. Peer support enhancement and evaluation review.Sec. 2203. Medicaid substance use disorder treatment via telehealth.Sec. 2204. Enhancing patient access to non-opioid treatment options.Sec. 2205. Assessing barriers to opioid use disorder treatment.Sec. 2206. Help for moms and babies.Sec. 2207. Securing flexibility to treat substance use disorders.Sec. 2208. MACPAC study and report on MAT utilization controls under State Medicaid programs.Sec. 2209. Opioid addiction treatment programs enhancement.Sec. 2210. Better data sharing to combat the opioid crisis.Sec. 2211. Mandatory reporting with respect to adult behavioral health measures.Sec. 2212. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid.Sec. 2213. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid.Subtitle C—Human ServicesSec. 2301. Supporting family-focused residential treatment.Sec. 2302. Improving recovery and reunifying families.Sec. 2303. Building capacity for family-focused residential treatment.Subtitle D—Synthetics Trafficking and Overdose PreventionSec. 2401. Short title.Sec. 2402. Customs fees.Sec. 2403. Mandatory advance electronic information for postal shipments.Sec. 2404. International postal agreements.Sec. 2405. Cost recoupment.Sec. 2406. Development of technology to detect illicit narcotics.Sec. 2407. Civil penalties for postal shipments.Sec. 2408. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest.Sec. 2409. Effective date; regulations.TITLE III—JudiciarySubtitle A—Access to Increased Drug DisposalSec. 3101. Short title.Sec. 3102. Definitions.Sec. 3103. Authority to make grants.Sec. 3104. Application.Sec. 3105. Use of grant funds.Sec. 3106. Eligibility for grant.Sec. 3107. Duration of grants.Sec. 3108. Accountability and oversight.Sec. 3109. Duration of program.Sec. 3110. Authorization of appropriations.Subtitle B—Using Data To Prevent Opioid DiversionSec. 3201. Short title.Sec. 3202. Purpose.Sec. 3203. Amendments.Sec. 3204. Report.Subtitle C—Substance Abuse PreventionSec. 3301. Short title.Sec. 3302. Reauthorization of the Office of National Drug Control Policy.Sec. 3303. Reauthorization of the Drug-Free Communities Program.Sec. 3304. Reauthorization of the National Community Anti-Drug Coalition Institute.Sec. 3305. Reauthorization of the High-Intensity Drug Trafficking Area Program.Sec. 3306. Reauthorization of drug court program.Sec. 3307. Drug court training and technical assistance.Sec. 3308. Drug overdose response strategy.Sec. 3309. Protecting law enforcement officers from accidental exposure.Sec. 3310. COPS Anti-Meth Program.Sec. 3311. COPS anti-heroin task force program.Sec. 3312. Comprehensive Addiction and Recovery Act education and awareness.Sec. 3313. Protecting children with addicted parents.Sec. 3314. Reimbursement of substance use disorder treatment professionals.Sec. 3315. Sobriety Treatment and Recovery Teams (START).Sec. 3316. Provider education.Sec. 3317. Demand reduction.Sec. 3318. Anti-drug media campaign.Sec. 3319. Technical corrections to the office of national drug control policy reauthorization act of 1998.Subtitle D—Synthetic Abuse and Labeling of Toxic SubstancesSec. 3401. Short title.Sec. 3402. Controlled substance analogues.Subtitle E—Opioid Quota ReformSec. 3501. Short title.Sec. 3502. Strengthening considerations for DEA opioid quotas.Subtitle F—Preventing Drug DiversionSec. 3601. Short title.Sec. 3602. Improvements to prevent drug diversion.Subtitle G—Sense of CongressSec. 3701. Sense of Congress.TITLE IV—CommerceSubtitle A—Fighting Opioid Abuse in TransportationSec. 4101. Short title.Sec. 4102. Rail mechanical employee controlled substances and alcohol testing.Sec. 4103. Rail yardmaster controlled substances and alcohol testing.Sec. 4104. Department of Transportation public drug and alcohol testing database.Sec. 4105. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data.Sec. 4106. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl.Sec. 4107. Status reports on hair testing guidelines.Sec. 4108. Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid.Sec. 4109. Electronic recordkeeping.Sec. 4110. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse.Subtitle B—Opioid Addiction Recovery Fraud PreventionSec. 4201. Short title.Sec. 4202. Definitions.Sec. 4203. False or misleading representations with respect to opioid treatment programs and products. I Opioid Crisis Response Act 1001. Definitions In this title— (1) the terms Indian Tribe and tribal organization have the meanings given the terms Indian tribe and tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); and (2) the term Secretary means the Secretary of Health and Human Services, unless otherwise specified. A Reauthorization of Cures Funding 1101. State response to the opioid abuse crisis (a) In general Section 1003 of the 21st Century Cures Act (Public Law 114–255) is amended— (1) in subsection (a)— (A) by striking the authorization of appropriations under subsection (b) to carry out the grant program described in subsection (c) and inserting subsection (h) to carry out the grant program described in subsection (b); and (B) by inserting and Indian Tribes after States; (2) by striking subsection (b); (3) by redesignating subsections (c) through (e) as subsections (b) through (d), respectively; (4) by redesignating subsection (f) as subsection (j); (5) in subsection (b), as so redesignated— (A) in paragraph (1)— (i) in the paragraph heading, by inserting and Indian Tribe after State; (ii) by striking States for the purpose of addressing the opioid abuse crisis within such States and inserting States and Indian Tribes for the purpose of addressing the opioid abuse crisis within such States and Indian Tribes; (iii) by inserting or Indian Tribes after preference to States; and (iv) by inserting before the period of the second sentence or other Indian Tribes, as applicable; (B) in paragraph (2)— (i) in the matter preceding subparagraph (A), by striking to a State; (ii) in subparagraph (A), by striking State; (iii) in subparagraph (C), by inserting preventing diversion of controlled substances, after treatment programs,; and (iv) in subparagraph (E), by striking as the State determines appropriate, related to addressing the opioid abuse crisis within the State and inserting as the State or Indian Tribe determines appropriate, related to addressing the opioid abuse crisis within the State, including directing resources in accordance with local needs related to substance use disorders; (6) in subsection (c), as so redesignated, by striking subsection (c) and inserting subsection (b); (7) in subsection (d), as so redesignated— (A) in the matter preceding paragraph (1), by striking the authorization of appropriations under subsection (b) and inserting subsection (h); and (B) in paragraph (1), by striking subsection (c) and inserting subsection (b); and (8) by inserting after subsection (d), as so redesignated, the following: (e) Indian Tribes (1) Definition For purposes of this section, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304). (2) Appropriate mechanisms The Secretary, in consultation with Indian Tribes, shall identify and establish appropriate mechanisms for Tribes to demonstrate or report the information as required under subsections (b), (c), and (d). (f) Report to Congress Not later than 1 year after the date on which amounts are first awarded after the date of enactment of the Opioid Crisis Response Act of 2018, pursuant to subsection (b), and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the information provided to the Secretary in reports made pursuant to subsection (c), including the purposes for which grant funds are awarded under this section and the activities of such grant recipients. (g) Technical Assistance The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide State agencies and Indian Tribes, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing the opioid crisis. (h) Authorization of appropriations For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $500,000,000 for each of fiscal years 2019 through 2021, to remain available until expended. (i) Set aside Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, 5 percent of such amount for such fiscal year shall be made available to Indian Tribes, and up to 15 percent of such amount for such fiscal year may be set aside for States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention. . (b) Conforming amendment Section 1004(c) of the 21st Century Cures Act (Public Law 114–255) is amended by striking , the FDA Innovation Account, or the Account For the State Response to the Opioid Abuse Crisis and inserting or the FDA Innovation Account. B Research and Innovation 1201. Advancing cutting-edge research Section 402(n)(1) of the Public Health Service Act (42 U.S.C. 282(n)(1)) is amended— (1) in subparagraph (A), by striking or; (2) in subparagraph (B), by striking the period and inserting ; or; and (3) by adding at the end the following: (C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat. . 1202. Pain research Section 409J(b) of the Public Health Service Act (42 U.S.C. 284q(b)) is amended— (1) in paragraph (5)— (A) in subparagraph (A), by striking and treatment of pain and diseases and disorders associated with pain and inserting treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; (B) in subparagraph (B), by striking on the symptoms and causes of pain; and inserting the following: “on— (i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain; (ii) the diagnosis, prevention, treatment, and management of acute or chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and (iii) risk factors for, and early warning signs of, substance use disorders; and ; and (C) by striking subparagraphs (C) through (E) and inserting the following: (C) make recommendations to the Director of NIH— (i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and (iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research. ; (2) by redesignating paragraph (6) as paragraph (7); and (3) by inserting after paragraph (5) the following: (6) Report The Director of NIH shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress. . 1203. Report on synthetic drug use (a) In general Not later than 3 years after the date of the enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the health effects of new psychoactive substances, including synthetic drugs, by adolescents and young adults. (b) New psychoactive substance defined For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32))). C Medical Products and Controlled Substances Safety 1301. Clarifying FDA regulation of non-addictive pain products (a) Public Meetings Not later than one year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction, which may include— (1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable; (2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction; (3) the evidentiary standards and the development of opioid sparing data for inclusion in the labeling of medical products; and (4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction. (b) Guidance Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding— (1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary— (A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction; (B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and (C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition; (2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence; (3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid sparing data in the labeling of non-addictive medical products intended to treat pain, including— (A) data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), as appropriate, to support product labeling; (B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; (D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and (E) the appropriate format in which to submit such data results to the Secretary; and (4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section. (c) Definitions In this section— (1) the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and (2) the term opioid sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances. 1302. Clarifying FDA packaging authorities (a) Additional potential elements of strategy Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding at the end the following: (4) Packaging and disposal The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug packaging, which may include requiring that— (A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or (B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs non-retrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary has determines that such safe disposal packaging or system may mitigate such serious risk and exists in sufficient quantities. . (b) Assuring access and minimizing burden Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(2)(C)) is amended— (1) in clause (i) by striking and at the end; and (2) by adding at the end the following: (iii) patients with functional needs; and . (c) Application to abbreviated new drug applications Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(i)) is amended— (1) in paragraph (1)— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) inserting after subparagraph (A) the following: (B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug. ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: (B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and . 1303. Strengthening FDA and CBP coordination and capacity (a) In general The Secretary, acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities). Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection. (b) FDA import facilities and inspection capacity (1) In general In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include— (A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate— (i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies; (ii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods; (iii) upgrades to the security of import facilities; and (iv) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and (B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate. (2) Innovative technology Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate. (c) Report Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the relevant committees of Congress on the implementation of this section, including a summary of progress made towards near-real-time information sharing and the interoperability of such technologies. (d) Authorization of appropriations Out of amounts otherwise available to the Secretary, the Secretary may allocate such sums as may be necessary for purposes of carrying out this section. 1304. Clarifying FDA post-market authorities Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling. 1305. Restricting entrance of illicit drugs (a) In general The Secretary, acting through the Commissioner of Food and Drugs, upon discovering or receiving, in a package being offered for import, a controlled substance that is offered for import in violation of any requirement of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law, shall transfer such package to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.). (b) Debarment, temporary denial of approval, and suspension (1) In general Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by inserting or (3) after paragraph (2); (ii) in subparagraph (A), by striking the comma at the end and inserting a semicolon; (iii) in subparagraph (B), by striking , or and inserting a semicolon; (iv) in subparagraph (C), by striking the period and inserting ; or; and (v) by adding at the end the following: (D) a person from importing or offering for import into the United States a drug. ; and (B) in paragraph (3)— (i) in the heading, by striking Food; (ii) in subparagraph (A), by striking ; or and inserting a semicolon; (iii) in subparagraph (B), by striking the period and inserting a semicolon; and (iv) by adding at the end the following: (C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); (D) the person has engaged in a pattern of importing or offering for import— (i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or (ii) adulterated or misbranded drugs that are— (I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or (II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. . (2) Prohibited act Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended by inserting or a drug after food. (c) Imports and exports Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— (1) by striking the second sentence; (2) by striking If it appears and inserting Subject to subsection (b), if it appears; (3) by striking regarding such article, then such article shall be refused and inserting the following: regarding such article, or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) may be refused admission. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.; (4) by striking this Act, then such article shall be refused admission and inserting this Act, then such article may be refused admission; and (5) by striking Clause (2) of the third sentence and all that follows through the period at the end and inserting the following: Neither clause (2) nor clause (5) of the second sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.. (d) Certain illicit articles Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following— (t) Illicit articles containing active pharmaceutical ingredients (1) In general For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— (A) is not— (i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and (ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, or a dietary supplement; and (B) is an ingredient that presents significant public health concern and is, or contains— (i) an active ingredient in a drug— (I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or (II) for which— (aa) an investigational use exemption is in effect under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i). (2) Effect This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). . 1306. First responder training Section 546 of the Public Health Service Act (42 U.S.C. 290ee–1) is amended— (1) in subsection (c)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3), by striking the period and inserting ; and; and (C) by adding at the end the following: (4) train and provide resources for first responders and members of other key community sectors on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure to such drugs and respond appropriately when exposure occurs. ; (2) in subsection (d), by striking and mechanisms for referral to appropriate treatment for an entity receiving a grant under this section and inserting mechanisms for referral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs; (3) in subsection (f)— (A) in paragraph (3), by striking and at the end; (B) in paragraph (4), by striking the period and inserting ; and; and (C) by adding at the end the following: (5) the number of first responders and members of other key community sectors trained on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs. ; (4) by redesignating subsection (g) as subsection (h); (5) by inserting after subsection (f) the following: (g) Other key community sectors In this section, the term other key community sectors includes substance abuse treatment providers, emergency medical services agencies, agencies and organizations working with prison and jail populations and offender reentry programs, health care providers, harm reduction groups, pharmacies, community health centers, tribal health facilities, and mental health providers. ; and (6) in subsection (h), as so redesignated, by striking $12,000,000 for each of fiscal years 2017 through 2021 and inserting $36,000,000 for each of fiscal years 2019 through 2023. 1307. Disposal of controlled substances of hospice patients (a) In general Section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)) is amended by adding at the end the following: (5) (A) An employee of a qualified hospice program acting within the scope of employment may handle, in the place of residence of a hospice patient, any controlled substance that was lawfully dispensed to the hospice patient, for the purpose of assisting in the disposal of the controlled substance— (i) after the hospice patient's death; (ii) if the controlled substance is expired; or (iii) if— (I) the employee is— (aa) the physician of the hospice patient; and (bb) registered under section 303(f); and (II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified. (B) In this paragraph: (i) The term employee of a qualified hospice program means a physician, physician assistant, registered nurse, or nurse practitioner who— (I) is employed by, or is acting pursuant to arrangements made with, a qualified hospice program; and (II) is licensed or certified to perform such employment, or such activities arranged by the qualified hospice program, in accordance with applicable State law. (ii) The terms hospice care and hospice program have the meanings given those terms in section 1861(dd) of the Social Security Act (42 U.S.C. 1395x(dd)). (iii) The term hospice patient means an individual receiving hospice care. (iv) The term qualified hospice program means a hospice program that— (I) has written policies and procedures for employees of the hospice program to use when assisting in the disposal of the controlled substances of a hospice patient in a circumstance described in clause (i), (ii), or (iii) of subparagraph (A); (II) at the time when the controlled substances are first ordered— (aa) provides a copy of the written policies and procedures to the hospice patient or hospice patient representative and the family of the hospice patient; (bb) discusses the policies and procedures with the hospice patient or hospice patient's representative and the hospice patient's family in a language and manner that such individuals understand to ensure that such individuals are informed regarding the safe disposal of controlled substances; and (cc) documents in the clinical record of the hospice patient that the written policies and procedures were provided and discussed with the hospice patient or hospice patient's representative; and (III) at the time when an employee of the hospice program assists in the disposal of controlled substances of a hospice patient, documents in the clinical record of the hospice patient a list of all controlled substances disposed of. (C) The Attorney General may, by regulation, include additional types of licensed medical professionals in the definition of the term employee of a qualified hospice program under subparagraph (B). . (b) No registration required Section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)) is amended by adding at the end the following: (4) An employee of a qualified hospice program for the purpose of assisting in the disposal of a controlled substance in accordance with subsection (g)(5), except as provided in subparagraph (A)(iii) of that subsection. . (c) Guidance The Attorney General may issue guidance to qualified hospice programs to assist the programs in satisfying the requirements under paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a). (d) State and local authority Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs. 1308. GAO study and report on hospice safe drug management (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General) shall conduct a study on the requirements applicable to and challenges of hospice programs with regard to the management and disposal of controlled substances in the home of an individual. (2) Contents In conducting the study under paragraph (1), the Comptroller General shall include— (A) an overview of challenges encountered by hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and (B) a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements. (b) Report Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate. 1309. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation (a) In general The Controlled Substances Act is amended by inserting after section 309 (21 U.S.C. 829) the following: 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner (a) In general Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if— (1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title; (2) in the case of administering of the controlled substance for the purpose of maintenance or detoxification treatment under section 303(g)(2)— (A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and (B) the controlled substance is to be administered by injection or implantation; (3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place; (4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and (6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General. (b) Modification of number of days before which controlled substance shall be administered (1) Initial 2-year period During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will— (A) reduce the risk of diversion; or (B) protect the public health. (2) Modifications after submission of report After the date on which the report described in subsection (c) is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5). (3) Minimum number of days Any modification under this subsection shall be for a period of not less than 7 days. . (b) Study and report Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation. (c) Technical and conforming amendment The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following: Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner. . D Treatment and Recovery 1401. Comprehensive opioid recovery centers (a) In general The Secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center (referred to in this section as a Center). A Center may be a single entity or an integrated delivery network. (b) Grant period (1) In general A grant awarded under subsection (a) shall be for a period not more than 5 years. (2) Renewal A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph, the Secretary shall consider the data submitted under subsection (h). (c) Minimum number of grants The Secretary shall allocate the amounts made available under subsection (j) such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a single State for any one period. (d) Application (1) Eligible entity An entity is eligible for a grant under this section if the entity offers treatment and other services for individuals with a substance use disorder. (2) Submission of application In order to be eligible for a grant under subsection (a), an entity shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activities described in subsection (g); and (B) such other information as the Secretary may require. (e) Priority In awarding grants under subsection (a), the Secretary shall give priority to eligible entities located in a State or Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (f) Preference In awarding grants under subsection (a), the Secretary may give preference to eligible entities utilizing technology-enabled collaborative learning and capacity building models, including such models as defined in section 2 of the Expanding Capacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to conduct the activities described in this section. (g) Center activities Each Center shall, at a minimum, carry out the following activities directly, through referral, or through contractual arrangements, which may include carrying out such activities through technology-enabled collaborative learning and capacity building models described in subsection (f): (1) Treatment and recovery services Each Center shall— (A) ensure that intake and evaluations meet the individualized clinical needs of patients, including by offering assessments for services and care recommendations through independent, evidence-based verification processes for reviewing patient placement in treatment settings; (B) provide the full continuum of treatment services, including— (i) all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law; (ii) medically supervised withdrawal management that includes patient evaluation, stabilization, and readiness for and entry into treatment; (iii) counseling provided by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor patient progress; (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders; (v) testing, as appropriate, for infections commonly associated with illicit drug use; (vi) residential rehabilitation, and outpatient and intensive outpatient programs; (vii) recovery housing; (viii) community-based and peer recovery support services; (ix) job training, job placement assistance, and continuing education assistance to support reintegration into the workforce; and (x) other best practices to provide the full continuum of treatment and services, as determined by the Secretary; (C) ensure that all programs covered by the Center include medication-assisted treatment, as appropriate, and do not exclude individuals receiving medication-assisted treatment from any service; (D) periodically conduct patient assessments to support sustained and clinically significant recovery, as defined by the Assistant Secretary for Mental Health and Substance Use; (E) administer an onsite pharmacy and provide toxicology services, for purposes of carrying out this section; and (F) operate a secure, confidential, and interoperable electronic health information system. (2) Outreach Each Center shall carry out outreach activities to publicize the services offered through the Centers, which may include— (A) training and supervising outreach staff, as appropriate, to work with State and local health departments, health care providers, the Indian Health Service, State and local educational agencies, schools funded by the Indian Bureau of Education, institutions of higher education, State and local workforce development boards, State and local community action agencies, public safety officials, first responders, Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including patients, to identify and respond to community needs; (B) ensuring that the entities described in subparagraph (A) are aware of the services of the Center; and (C) disseminating and making publicly available, including through the internet, evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders, including co-occurring substance use and mental disorders. (h) Data reporting and program oversight With respect to a grant awarded under subsection (a), not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period (including the duration of any renewal period for such grant), the entity shall submit data, as appropriate, to the Secretary regarding— (1) the programs and activities funded by the grant; (2) health outcomes of the population of individuals with a substance use disorder who received services from the Center, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the Secretary; (3) the retention rate of program participants; and (4) any other information that the Secretary may require for the purpose of ensuring that the Center is complying with all the requirements of the grant, including providing the full continuum of services described in subsection (g)(1)(B). (i) Privacy The provisions of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (j) Authorization of appropriations There is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. (k) Reports to Congress (1) Preliminary report Not later than 3 years after the date of the enactment of this Act, the Secretary shall submit to Congress a preliminary report that analyzes data submitted under subsection (h). (2) Final report Not later than 2 years after submitting the preliminary report required under paragraph (1), the Secretary shall submit to Congress a final report that includes— (A) an evaluation of the effectiveness of the comprehensive services provided by the Centers established or operated pursuant to this section with respect to health outcomes of the population of individuals with substance use disorder who receive services from the Center, which shall include an evaluation of the effectiveness of services for treatment and recovery support and to reduce relapse, recidivism, and overdose; and (B) recommendations, as appropriate, regarding ways to improve Federal programs related to substance use disorders, which may include dissemination of best practices for the treatment of substance use disorders to health care professionals. 1402. Program to support coordination and continuation of care for drug overdose patients (a) In general The Secretary shall identify or facilitate the development of best practices for— (1) emergency treatment of known or suspected drug overdose; (2) the use of recovery coaches, as appropriate, to encourage individuals who experience a non-fatal overdose to seek treatment for substance use disorder and to support coordination and continuation of care; (3) coordination and continuation of care and treatment, including, as appropriate, through referrals, of individuals after an opioid overdose; and (4) the provision of overdose reversal medication, as appropriate. (b) Grant establishment and participation (1) In general The Secretary shall award grants on a competitive basis to eligible entities to support implementation of voluntary programs for care and treatment of individuals after an opioid overdose, as appropriate, which may include implementation of the best practices described in subsection (a). (2) Eligible entity In this section, the term eligible entity means— (A) a State alcohol or drug agency; (B) an Indian Tribe or tribal organization; or (C) an entity that offers treatment or other services for individuals in response to, or following, drug overdoses or a drug overdose, in consultation with a State alcohol and drug agency. (3) Application An eligible entity desiring a grant under this section shall submit an application to the Secretary, at such time and in such manner as the Secretary may require, that includes— (A) evidence that such eligible entity carries out, or is capable of contracting and coordinating with other community entities to carry out, the activities described in paragraph (4); (B) evidence that such eligible entity will work with a recovery community organization to recruit, train, hire, mentor, and supervise recovery coaches and fulfill the requirements described in paragraph (4)(A); and (C) such additional information as the Secretary may require. (4) Use of grant funds An eligible entity awarded a grant under this section shall use such grant funds to— (A) hire or utilize recovery coaches to help support recovery, including by— (i) connecting patients to a continuum of care services, such as— (I) treatment and recovery support programs; (II) programs that provide non-clinical recovery support services; (III) peer support networks; (IV) recovery community organizations; (V) health care providers, including physicians and other providers of behavioral health and primary care; (VI) education and training providers; (VII) employers; (VIII) housing services; and (IX) child welfare agencies; (ii) providing education on overdose prevention and overdose reversal to patients and families, as appropriate; (iii) providing follow-up services for patients after an overdose to ensure continued recovery and connection to support services; (iv) collecting and evaluating outcome data for patients receiving recovery coaching services; and (v) providing other services the Secretary determines necessary to help ensure continued connection with recovery support services, including culturally appropriate services, as applicable; (B) establish policies and procedures, pursuant to Federal and State law, that address the provision of overdose reversal medication, the administration of all drugs approved by the Food and Drug Administration to treat substance use disorder, and subsequent continuation of, or referral to, evidence-based treatment for patients with a substance use disorder who have experienced a non-fatal drug overdose, in order to support long-term treatment, prevent relapse, and reduce recidivism and future overdose; and (C) establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment, follow up, and transportation to and from treatment facilities. (5) Additional permissible uses In addition to the uses described in paragraph (4), a grant awarded under this section may be used, directly or through contractual arrangements, to provide— (A) all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law; (B) withdrawal and detoxification services that include patient evaluation, stabilization, and preparation for treatment of substance use disorder, including treatment described in subparagraph (A), as appropriate; or (C) mental health services provided by a program counselor, social worker, therapist, or other certified professional who is licensed and qualified by education, training, or experience to assess the psychosocial background of patients, to contribute to the appropriate treatment plan for patients with substance use disorder, and to monitor patient progress. (6) Preference In awarding grants under this section, the Secretary shall give preference to eligible entities that meet any or all of the following criteria: (A) The eligible entity is a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act (42 U.S.C. 1395x(mm)(1))), a low volume hospital (as defined in section 1886(d)(12)(C)(i) of such Act (42 U.S.C. 1395ww(d)(12)(C)(i))), or a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act (42 U.S.C. 1395ww(d)(5)(D)(iii))). (B) The eligible entity is located in a State, or under the jurisdiction of an Indian Tribe, with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community settings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Recovery coach the term recovery coach means an individual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (2) Recovery community organization The term recovery community organization has the meaning given such term in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)). (3) State alcohol and drug agency The term State alcohol and drug agency means the principal agency of a State that is responsible for carrying out the block grant for prevention and treatment of substance abuse under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.) (d) Reporting requirements (1) Reports by grantees Each eligible entity awarded a grant under this section shall submit to the Secretary an annual report for each year for which the entity has received such grant that includes information on— (A) the number of individuals treated by the entity for non-fatal overdoses, including the number of non-fatal overdoses where overdose reversal medication was administered; (B) the number of individuals administered medication-assisted treatment by the entity; (C) the number of individuals referred by the entity to other treatment facilities after a non-fatal overdose, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals; and (D) the frequency and number of patients with reoccurrences, including readmissions for non-fatal overdoses and evidence of relapse related to substance use disorder. (2) Report by Secretary Not later than 5 years after the date of enactment of this Act, the Secretary shall submit to Congress a report that includes an evaluation of the effectiveness of the grant program carried out under this section with respect to long term health outcomes of the population of individuals who have experienced a drug overdose, the percentage of patients treated or referred to treatment by grantees, and the frequency and number of patients who experienced relapse, were readmitted for treatment, or experienced another overdose. (e) Privacy The requirements of this section, including with respect to data reporting and program oversight, shall be subject to all applicable Federal and State privacy laws. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2019 through 2023. 1403. Alternatives to opioids (a) In general The Secretary shall, directly or through grants to, or contracts with, public and private entities, provide technical assistance to hospitals and other acute care settings on alternatives to opioids for pain management. The technical assistance provided shall be for the purpose of— (1) utilizing information from acute care providers including emergency departments and other providers that have successfully implemented alternatives to opioids programs, promoting non-addictive protocols and medications while appropriately limiting the use of opioids; (2) identifying or facilitating the development of best practices on the use of alternatives to opioids, which may include pain-management strategies that involve non-addictive medical products, non-pharmacologic treatments, and technologies or techniques to identify patients at risk for opioid use disorder; (3) identifying or facilitating the development of best practices on the use of alternatives to opioids that target common painful conditions and include certain patient populations, such as geriatric patients, pregnant women, and children; (4) disseminating information on the use of alternatives to opioids to providers in acute care settings, which may include emergency departments, outpatient clinics, critical access hospitals, Federally qualified health centers, Indian Health Service health facilities, and tribal hospitals; and (5) collecting data and reporting on health outcomes associated with the use of alternatives to opioids. (b) Pain management and funding (1) In general The Secretary shall award grants to hospitals and other acute care settings relating to alternatives to opioids for pain management. (2) Authorization of appropriations There is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023 for purposes of carrying out this section. 1404. Building communities of recovery Section 547 of the Public Health Service Act (42 U.S.C. 290ee–2) is amended to read as follows: 547. Building communities of recovery (a) Definition In this section, the term recovery community organization means an independent nonprofit organization that— (1) mobilizes resources within and outside of the recovery community, which may include through a peer support network, to increase the prevalence and quality of long-term recovery from substance use disorders; and (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community served. (b) Grants authorized The Secretary shall award grants to recovery community organizations to enable such organizations to develop, expand, and enhance recovery services. (c) Federal share The Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent. (d) Use of funds Grants awarded under subsection (b)— (1) shall be used to develop, expand, and enhance community and statewide recovery support services; and (2) may be used to— (A) build connections between recovery networks, including between recovery community organizations and peer support networks, and with other recovery support services, including— (i) behavioral health providers; (ii) primary care providers and physicians; (iii) educational and vocational schools; (iv) employers; (v) housing services; (vi) child welfare agencies; and (vii) other recovery support services that facilitate recovery from substance use disorders, including non-clinical community services; (B) reduce the stigma associated with substance use disorders; and (C) conduct outreach on issues relating to substance use disorders and recovery, including— (i) identifying the signs of substance use disorder; (ii) the resources available to individuals with substance use disorder and to families of an individual with a substance use disorder, including programs that mentor and provide support services to children; (iii) the resources available to help support individuals in recovery; and (iv) related medical outcomes of substance use disorders, the potential of acquiring an infection commonly associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during pregnancy. (e) Special consideration In carrying out this section, the Secretary shall give special consideration to the unique needs of rural areas, including areas with an age-adjusted rate of drug overdose deaths that is above the national average and areas with a shortage of prevention and treatment services. (f) Authorization of appropriations There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2019 through 2023. . 1405. Peer support technical assistance center (a) Establishment The Secretary, acting through the Assistant Secretary for Mental Health and Substance Abuse, shall establish or operate a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this subsection as the Center). (b) Functions The Center established under subsection (a) shall provide technical assistance and support to recovery community organizations and peer support networks, including such assistance and support related to— (1) training on identifying— (A) signs of substance use disorder; (B) resources to assist individuals with a substance use disorder, or resources for families of an individual with a substance use disorder; and (C) best practices for the delivery of recovery support services; (2) the provision of translation services, interpretation, or other such services for clients with limited English speaking proficiency; (3) data collection to support research, including for translational research; (4) capacity building; and (5) evaluation and improvement, as necessary, of the effectiveness of such services provided by recovery community organizations (as defined in section 547 of the Public Health Service Act). (c) Best practices The Center established under subsection (a) shall periodically issue best practices for use by recovery community organizations and peer support networks. (d) Recovery community organization In this section, the term recovery community organization has the meaning given such term in section 547 of the Public Health Service Act. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2019 through 2023. 1406. Medication-assisted treatment for recovery from addiction (a) Waivers for maintenance treatment or detoxification Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following: (VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that— (aa) included not less than 24 hours of training on treating and managing opioid-dependent patients; and (bb) included, at a minimum— (AA) the training described in items (aa) through (gg) of subclause (IV); and (BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives. . (b) Treatment for children The Secretary shall consider ways to ensure that an adequate number of physicians who meet the requirements under the amendment made by subsection (a) and have a specialty in pediatrics, or the treatment of children or of adolescents, are granted a waiver under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) to treat children and adolescents with substance use disorders. (c) Technical amendment Section 102(24) of the Controlled Substances Act (21 U.S.C. 802(24)) is amended by striking Health, Education, and Welfare and inserting Health and Human Services. 1407. Grant program (a) In general The Secretary shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 1406(a) of this Act. (b) Authorization of appropriations There is authorized to be appropriated for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023. 1408. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; or (bb) 275 if the practitioner meets the requirements specified in section 8.610 of title 42, Code of Federal Regulations (or successor regulations). . 1409. National recovery housing best practices (a) Best practices for operating recovery housing (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing. (2) Consultation In carrying out the activities described in paragraph (1) the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Secretary of Housing and Urban Development; (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (D) representatives of health insurance issuers; (E) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian Tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (F) individuals with a history of substance use disorder; and (G) other stakeholders identified by the Secretary. (b) Identification of fraudulent recovery housing operators (1) In general The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators. (2) Consultation In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate— (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services; (B) the Attorney General; (C) the Secretary of Housing and Urban Development; (D) directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies; (E) representatives of health insurance issuers; (F) national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian Tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable; (G) individuals with a history of substance use disorder; and (H) other stakeholders identified by the Secretary. (3) Requirements (A) Practices for identification and reporting In carrying out the activities described in this subsection, the Secretary shall consider how law enforcement, public and private payers, and the public can best identify and report fraudulent recovery housing operators. (B) Factors to be considered In carrying out the activities described in this subsection, the Secretary shall consider identifying or developing indicators regarding— (i) unusual billing practices; (ii) average lengths of stays; (iii) excessive levels of drug testing (in terms of cost or frequency); (iv) unusually high levels of recidivism; and (v) any other factors identified by the Secretary. (c) Dissemination The Secretary shall, as appropriate, disseminate the best practices identified or developed under subsection (a), and the common indicators identified or developed under subsection (b), to— (1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices; (2) Indian Tribes, tribal organizations, and tribally designated housing entities; (3) the Attorney General; (4) the Secretary of Labor; (5) the Secretary of Housing and Urban Development; (6) State and local law enforcement agencies; (7) health insurance issuers; (8) recovery housing entities; and (9) the public. (d) Requirements In carrying out the activities under subsections (a) and (b), the Secretary, in consultation with appropriate stakeholders as described in each such subsection, shall consider how recovery housing is able to support recovery and prevent relapse, recidivism, or overdose (including overdose death), including by improving access and adherence to treatment, including medication-assisted treatment. (e) Rule of construction Nothing in this section shall be construed to provide the Secretary with the authority to require States to adhere to minimum standards in the State oversight of recovery housing. (f) Definitions In this section— (1) the term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders; and (2) the term tribally designated housing entity has the meaning given such term in section 4 of the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4103). 1410. Addressing economic and workforce impacts of the opioid crisis (a) Definitions Except as otherwise expressly provided, in this section: (1) WIOA definitions The terms core program, individual with a barrier to employment, local area, local board, one-stop operator, outlying area, State, State board, and supportive services have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102). (2) Education provider The term education provider means— (A) an institution of higher education, as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001); or (B) a postsecondary vocational institution, as defined in section 102(c) of such Act (20 U.S.C. 1002(c)). (3) Eligible entity The term eligible entity means— (A) a State workforce agency; (B) an outlying area; or (C) a Tribal entity. (4) Participating partnership The term participating partnership means a partnership— (A) evidenced by a written contract or agreement; and (B) including, as members of the partnership, a local board receiving a subgrant under subsection (d) and 1 or more of the following: (i) The eligible entity. (ii) A treatment provider. (iii) An employer or industry organization. (iv) An education provider. (v) A legal service or law enforcement organization. (vi) A faith-based or community-based organization. (vii) Other State or local agencies, including counties or local governments. (viii) Other organizations, as determined to be necessary by the local board. (ix) Indian Tribes or tribal organizations. (5) Program participant The term program participant means an individual who— (A) is a member of a population of workers described in subsection (e)(2) that is served by a participating partnership through the pilot program under this section; and (B) enrolls with the applicable participating partnership to receive any of the services described in subsection (e)(3). (6) Provider of peer recovery support services The term provider of peer recovery support services means a provider that delivers peer recovery support services through an organization described in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)). (7) Secretary The term Secretary means the Secretary of Labor. (8) State workforce agency The term State workforce agency means the lead State agency with responsibility for the administration of a program under chapter 2 or 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act (29 U.S.C. 3161 et seq., 3171 et seq.). (9) Substance use disorder The term substance use disorder has the meaning given such term by the Assistant Secretary for Mental Health and Substance Use. (10) Treatment provider The term treatment provider— (A) means a health care provider that— (i) offers services for treating substance use disorders and is licensed in accordance with applicable State law to provide such services; and (ii) accepts health insurance for such services, including coverage under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.); and (B) may include— (i) a nonprofit provider of peer recovery support services; (ii) a community health care provider; (iii) a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x)); (iv) an Indian health program (as defined in section 3 of the Indian Health Care Improvement Act (25 U.S.C. 1603)), including an Indian health program that serves an urban center (as defined in such section); and (v) a Native Hawaiian health center (as defined in section 12 of the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11711)). (11) Tribal entity The term Tribal entity includes any Indian Tribe, tribal organization, Indian-controlled organization serving Indians, Native Hawaiian organization, or Alaska Native entity, as such terms are defined or used in section 166 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3221). (b) Pilot program and grants authorized (1) In general The Secretary, in consultation with the Secretary of Health and Human Services, shall carry out a pilot program to address economic and workforce impacts associated with a high rate of a substance use disorder. In carrying out the pilot program, the Secretary shall make grants, on a competitive basis, to eligible entities to enable such entities to make subgrants to local boards to address the economic and workforce impacts associated with a high rate of a substance use disorder. (2) Grant amounts The Secretary shall make each such grant in an amount that is not less than $500,000, and not more than $5,000,000, for a fiscal year. (c) Grant applications (1) In general An eligible entity applying for a grant under this section shall submit an application to the Secretary at such time and in such form and manner as the Secretary may reasonably require, including the information described in this subsection. (2) Significant impact on community by opioid and substance use disorder-related problems (A) Demonstration An eligible entity shall include in the application— (i) information that demonstrates significant impact on the community by problems related to opioid abuse or another substance use disorder, by— (I) identifying the counties, communities, regions, or local areas that have been significantly impacted and will be served through the grant (each referred to in this section as a service area); and (II) demonstrating for each such service area, an increase equal to or greater than the national increase in such problems, between— (aa) 1999; and (bb) 2016 or the latest year for which data are available; and (ii) a description of how the eligible entity will prioritize support for significantly impacted service areas described in clause (i)(I). (B) Information To meet the requirements described in subparagraph (A)(i)(II), the eligible entity may use information including data on— (i) the incidence or prevalence of opioid abuse and other substance use disorders; (ii) the age-adjusted rate of drug overdose deaths, as determined by the Director of the Centers for Disease Control and Prevention; (iii) the rate of non-fatal hospitalizations related to opioid abuse or other substance use disorders; (iv) the number of arrests or convictions, or a relevant law enforcement statistic, that reasonably shows an increase in opioid abuse or another substance use disorder; or (v) in the case of an eligible entity described in subsection (a)(3)(C), other alternative relevant data as determined appropriate by the Secretary. (C) Support for state strategy The eligible entity may include in the application information describing how the proposed services and activities are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing problems described in subparagraph (A) in specific service areas or across the State, outlying area, or Tribal land. (3) Economic and employment conditions demonstrate additional Federal support needed (A) Demonstration An eligible entity shall include in the application information that demonstrates that a high rate of a substance use disorder has caused, or is coincident to— (i) an economic or employment downturn in the service area; or (ii) persistent economically depressed conditions in such service area. (B) Information To meet the requirements of subparagraph (A), an eligible entity may use information including— (i) documentation of any layoff, announced future layoff, legacy industry decline, decrease in an employment or labor market participation rate, or economic impact, whether or not the result described in this clause is overtly related to a high rate of a substance use disorder; (ii) documentation showing decreased economic activity related to, caused by, or contributing to a high rate of a substance use disorder, including a description of how the service area has been impacted, or will be impacted, by such a decrease; (iii) information on economic indicators, labor market analyses, information from public announcements, and demographic and industry data; (iv) information on rapid response activities (as defined in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102)) that have been or will be conducted, including demographic data gathered by employer or worker surveys or through other methods; (v) data or documentation, beyond anecdotal evidence, showing that employers face challenges filling job vacancies due to a lack of skilled workers able to pass a drug test; or (vi) any additional relevant data or information on the economy, workforce, or another aspect of the service area to support the application. (d) Subgrant authorization and application process (1) Subgrants authorized (A) In general An eligible entity receiving a grant under subsection (b)— (i) may use not more than 5 percent of the grant funds for the administrative costs of carrying out the grant; (ii) in the case of an eligible entity described in subparagraph (A) or (B) of subsection (a)(3), shall use the remaining grant funds to make subgrants to local entities in the service area to carry out the services and activities described in subsection (e); and (iii) in the case of an eligible entity described in subsection (a)(3)(C), shall use the remaining grant funds to carry out the services and activities described in subsection (e). (B) Equitable distribution In making subgrants under this subsection, an eligible entity shall ensure, to the extent practicable, the equitable distribution of subgrants, based on— (i) geography (such as urban and rural distribution); and (ii) significantly impacted service areas as described in subsection (c)(2). (C) Timing of subgrant funds distribution An eligible entity making subgrants under this subsection shall disburse subgrant funds to a local board receiving a subgrant from the eligible entity by the later of— (i) the date that is 90 days after the date on which the Secretary makes the funds available to the eligible entity; or (ii) the date that is 15 days after the date that the eligible entity makes the subgrant under subparagraph (A)(ii). (2) Subgrant application (A) In general A local board desiring to receive a subgrant under this subsection from an eligible entity shall submit an application at such time and in such manner as the eligible entity may reasonably require, including the information described in this paragraph. (B) Contents Each application described in subparagraph (A) shall include— (i) an analysis of the estimated performance of the local board in carrying out the proposed services and activities under the subgrant— (I) based on— (aa) primary indicators of performance described in section 116(c)(1)(A)(i) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3141(c)(1)(A)(i), to assess estimated effectiveness of the proposed services and activities, including the estimated number of individuals with a substance use disorder who may be served by the proposed services and activities; (bb) the record of the local board in serving individuals with a barrier to employment; and (cc) the ability of the local board to establish a participating partnership; and (II) which may include or utilize— (aa) data from the National Center for Health Statistics of the Centers for Disease Control and Prevention; (bb) data from the Center for Behavioral Health Statistics and Quality of the Substance Abuse and Mental Health Services Administration; (cc) State vital statistics; (dd) municipal police department records; (ee) reports from local coroners; or (ff) other relevant data; and (ii) in the case of a local board proposing to serve a population described in subsection (e)(2)(B), a demonstration of the workforce shortage in the professional area to be addressed under the subgrant (which may include substance use disorder treatment and related services, non-addictive pain therapy and pain management services, mental health care treatment services, emergency response services, or mental health care), which shall include information that can demonstrate such a shortage, such as— (I) the distance between— (aa) communities affected by opioid abuse or another substance use disorder; and (bb) facilities or professionals offering services in the professional area; or (II) the maximum capacity of facilities or professionals to serve individuals in an affected community, or increases in arrests related to opioid or another substance use disorder, overdose deaths, or nonfatal overdose emergencies in the community. (e) Subgrant services and activities (1) In general Each local board that receives a subgrant under subsection (d) shall carry out the services and activities described in this subsection through a participating partnership. (2) Selection of Population to be served A participating partnership shall elect to provide services and activities under the subgrant to one or both of the following populations of workers: (A) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), each of whom— (i) is directly or indirectly affected by a high rate of a substance use disorder; and (ii) voluntarily confirms that the worker, or a friend or family member of the worker, has a history of opioid abuse or another substance use disorder. (B) Workers, including dislocated workers, individuals with barriers to employment, new entrants in the workforce, or incumbent workers (employed or underemployed), who— (i) seek to transition to professions that support individuals with a substance use disorder or at risk for developing such disorder, such as professions that provide— (I) substance use disorder treatment and related services; (II) services offered through providers of peer recovery support services; (III) non-addictive pain therapy and pain management services; (IV) emergency response services; or (V) mental health care; and (ii) need new or upgraded skills to better serve such a population of struggling or at-risk individuals. (3) Services and activities Each participating partnership shall use funds available through a subgrant under this subsection to carry out 1 or more of the following: (A) Engaging employers Engaging with employers to— (i) learn about the skill and hiring requirements of employers; (ii) learn about the support needed by employers to hire and retain program participants, and other individuals with a substance use disorder, and the support needed by such employers to obtain their commitment to testing creative solutions to employing program participants and such individuals; (iii) connect employers and workers to on-the-job or customized training programs before or after layoff to help facilitate reemployment; (iv) connect employers with an education provider to develop classroom instruction to complement on-the-job learning for program participants and such individuals; (v) help employers develop the curriculum design of a work-based learning program for program participants and such individuals; (vi) help employers employ program participants or such individuals engaging in a work-based learning program for a transitional period before hiring such a program participant or individual for full-time employment of not less than 30 hours a week; or (vii) connect employers to program participants receiving concurrent outpatient treatment and job training services. (B) Screening services Providing screening services, which may include— (i) using an evidence-based screening method to screen each individual seeking participation in the pilot program to determine whether the individual has a substance use disorder; (ii) conducting an assessment of each such individual to determine the services needed for such individual to obtain or retain employment, including an assessment of strengths and general work readiness; or (iii) accepting walk-ins or referrals from employers, labor organizations, or other entities recommending individuals to participate in such program. (C) Individual treatment and employment plan Developing an individual treatment and employment plan for each program participant— (i) in coordination, as appropriate, with other programs serving the participant such as the core programs within the workforce development system under the Workforce Innovation and Opportunity Act (29 U.S.C. 3101 et seq.); and (ii) which shall include providing a case manager to work with each participant to develop the plan, which may include— (I) identifying employment and career goals; (II) exploring career pathways that lead to in-demand industries and sectors, as determined by the State board and the head of the State workforce agency or, as applicable, the Tribal entity; (III) setting appropriate achievement objectives to attain the employment and career goals identified under subclause (I); or (IV) developing the appropriate combination of services to enable the participant to achieve the employment and career goals identified under subclause (I). (D) Outpatient treatment and recovery care In the case of a participating partnership serving program participants described in paragraph (2)(A) with a substance use disorder, providing individualized and group outpatient treatment and recovery services for such program participants that are offered during the day and evening, and on weekends. Such treatment and recovery services— (i) shall be based on a model that utilizes combined behavioral interventions and other evidence-based or evidence-informed interventions; and (ii) may include additional services such as— (I) health, mental health, addiction, or other forms of outpatient treatment that may impact a substance use disorder and co-occurring conditions; (II) drug testing for a current substance use disorder prior to enrollment in career or training services or prior to employment; (III) linkages to community services, including services offered by partner organizations designed to support program participants; or (IV) referrals to health care, including referrals to substance use disorder treatment and mental health services. (E) Supportive services Providing supportive services, which shall include services such as— (i) coordinated wraparound services to provide maximum support for program participants to assist the program participants in maintaining employment and recovery for not less than 12 months, as appropriate; (ii) assistance in establishing eligibility for assistance under Federal, State, Tribal, and local programs providing health services, mental health services, vocational services, housing services, transportation services, social services, or services through early childhood education programs (as defined in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003)); (iii) services offered through providers of peer recovery support services; (iv) networking and mentorship opportunities; or (v) any supportive services determined necessary by the local board. (F) Career and job training services Offering career services and training services, and related services, concurrently or sequentially with the services provided under subparagraphs (B) through (E). Such services shall include the following: (i) Services provided to program participants who are in a pre-employment stage of the program, which may include— (I) initial education and skills assessments; (II) traditional classroom training funded through individual training accounts under chapter 3 of subtitle B of title I of the Workforce Innovation and Opportunity Act (29 U.S.C. 3171 et seq.); (III) services to promote employability skills such as punctuality, personal maintenance skills, and professional conduct; (IV) in-depth interviewing and evaluation to identify employment barriers and to develop individual employment plans; (V) career planning that includes— (aa) career pathways leading to in-demand, high-wage jobs; and (bb) job coaching, job matching, and job placement services; (VI) provision of payments and fees for employment and training-related applications, tests, and certifications; or (VII) any other appropriate career service or training service described in section 134(c) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174(c)). (ii) Services provided to program participants during their first 6 months of employment to ensure job retention, which may include— (I) case management and support services, including a continuation of the services described in clause (i); (II) a continuation of skills training, and career and technical education, described in clause (i) that is conducted in collaboration with the employers of such participants; (III) mentorship services and job retention support for such participants; or (IV) targeted training for managers and workers working with such participants (such as mentors), and human resource representatives in the business in which such participants are employed. (iii) Services to assist program participants in maintaining employment for not less than 12 months, as appropriate. (G) Proven and promising practices Leading efforts in the service area to identify and promote proven and promising strategies and initiatives for meeting the needs of employers and program participants. (4) Limitations A participating partnership may not use— (A) more than 10 percent of the funds received under a subgrant under subsection (d) for the administrative costs of the partnership; (B) more than 10 percent of the funds received under such subgrant for the provision of treatment and recovery services, as described in paragraph (3)(D); and (C) more than 10 percent of the funds received under such subgrant for the provision of supportive services described in paragraph (3)(E) to program participants. (f) Performance accountability (1) Reports The Secretary shall establish quarterly reporting requirements for recipients of grants and subgrants under this section that, to the extent practicable, are based on the performance accountability system under section 116 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3141) and, in the case of a grant awarded to an eligible entity described in subsection (a)(3)(C), section 166(h) of such Act (29 U.S.C. 3221(h)), including the indicators described in subsection (c)(1)(A)(i) of such section 116 and the requirements for local area performance reports under subsection (d) of such section 116. (2) Evaluations (A) Authority to enter into agreements The Secretary shall ensure that an independent evaluation is conducted on the pilot program carried out under this section to determine the impact of the program on employment of individuals with substance use disorders. The Secretary shall enter into an agreement with eligible entities receiving grants under this section to pay for all or part of such evaluation. (B) Methodologies to be used The independent evaluation required under this paragraph shall use experimental designs using random assignment or, when random assignment is not feasible, other reliable, evidence-based research methodologies that allow for the strongest possible causal inferences. (g) Funding (1) Covered fiscal year In this subsection, the term covered fiscal year means any of fiscal years 2018 through 2023. (2) Using funding for national dislocated worker grants Subject to paragraph (4) and notwithstanding section 132(a)(2)(A) and subtitle D of the Workforce Innovation and Opportunity Act (29 U.S.C. 3172(a)(2)(A), 3221 et seq.), the Secretary may use, to carry out the pilot program under this section for a covered fiscal year— (A) funds made available to carry out section 170 of such Act (29 U.S.C. 3225) for that fiscal year; (B) funds made available to carry out section 170 of such Act that remain available for that fiscal year; and (C) funds that remain available under section 172(f) of such Act (29 U.S.C. 3227(f)). (3) Availability of funds Funds appropriated under section 136(c) of such Act (29 U.S.C. 3181(c)) and made available to carry out section 170 of such Act for a fiscal year shall remain available for use under paragraph (2) for a subsequent fiscal year until expended. (4) Limitation The Secretary may not use more than $100,000,000 of the funds described in paragraph (2) for any covered fiscal year under this section. 1411. Career Act (a) In general The Secretary, in consultation with the Secretary of Labor, shall continue or establish a program to support individuals in recovery from a substance use disorder transition to independent living and the workforce. (b) Grants authorized In carrying out the activities under this section, the Secretary shall, on a competitive basis, award grants for a period of not more than 5 years to entities to enable such entities to carry out evidence-based programs to help individuals in recovery from a substance use disorder transition from treatment to independent living and the workforce. Such entities shall coordinate, as applicable, with Indian tribes or tribal organizations (as applicable), State boards and local boards (as defined in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102), lead State agencies with responsibility for a workforce investment activity (as defined in such section 3), and State agencies responsible for carrying out substance use disorder prevention and treatment programs. (c) Priority In awarding grants under this section, the Secretary shall give priority to entities located in a State with— (1) an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; (2) a rate of unemployment, based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017, that is above the national average; and (3) a rate of labor force participation, based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017, that is below the national average. (d) Preference In awarding grants under this section, the Secretary shall, as appropriate, give preference to entities located in an area with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate. (e) Applications An eligible entity shall submit an application at such time and in such manner as the Secretary may require. In submitting an application, the entity shall demonstrate the ability to partner with local stakeholders, which may include local employers, community stakeholders, the local workforce development board, and local and State governments, to— (1) identify gaps in the workforce due to the prevalence of substance use disorders; (2) in coordination with statewide employment and training activities, including coordination and alignment of activities carried out by entities provided grant funds under section 1410, help individuals in recovery from a substance use disorder transition into the workforce, including by providing career services, training services as described in paragraph (2) of section 134(c) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174(c)), and related services described in section 134(a)(3) of such Act (42 U.S.C. 3174(a)); and (3) assist employers with informing their employees of the resources, such as resources related to substance use disorders that are available to their employees. (f) Use of funds An entity receiving a grant under this section shall use the funds to conduct one or more of the following activities: (1) Hire case managers, care coordinators, providers of peer recovery support services, as described in section 547(a) of the Public Health Service Act (42 U.S.C. 290ee–2(a)), or other professionals, as appropriate, to provide services that support treatment, recovery, and rehabilitation, and prevent relapse, recidivism, and overdose, including by encouraging— (A) the development of daily living skills; and (B) the use of counseling, care coordination, and other services, as appropriate, to support recovery from substance use disorders. (2) Implement or utilize innovative technologies, which may include the use of telemedicine. (3) In coordination with the lead State agency with responsibility for a workforce investment activity or local board described in subsection (b), provide— (A) short-term prevocational training services; and (B) training services that are directly linked to the employment opportunities in the local area or the planning region. (g) Support for State strategy An eligible entity shall include in its application under subsection (e) information describing how the services and activities proposed in such application are aligned with the State, outlying area, or Tribal strategy, as applicable, for addressing issues described in such application and how such entity will coordinate with existing systems to deliver services as described in such application. (h) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary for each of fiscal years 2019 through 2023 for purposes of carrying out this section. 1412. Pilot program to help individuals in recovery from a substance use disorder become stably housed (a) Authorization of appropriations There is authorized to be appropriated under this section such sums as may be necessary for each of fiscal years 2019 through 2023 for assistance to States to provide individuals in recovery from a substance use disorder stable, temporary housing for a period of not more than 2 years or until the individual secures permanent housing, whichever is earlier. (b) Allocation of appropriated amounts (1) In general The amounts appropriated or otherwise made available to States under this section shall be allocated based on a funding formula established by the Secretary of Housing and Urban Development (referred to in this section as the Secretary) not later than 60 days after the date of enactment of this Act. (2) Criteria The funding formula required under paragraph (1) shall ensure that any amounts appropriated or otherwise made available under this section are allocated to States with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, according to the Centers for Disease Control and Prevention. Among such States, priority shall be given to States with the greatest need, as such need is determined by the Secretary based on— (A) the highest average rates of unemployment based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; (B) the lowest average labor force participation rates based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; and (C) the highest prevalence of opioid use disorder based on data provided by the Substance Abuse and Mental Health Services Administration for calendar years 2013 through 2017. (3) Distribution Amounts appropriated or otherwise made available under this section shall be distributed according to the funding formula established by the Secretary under paragraph (1) not later than 30 days after the establishment of such formula. (c) Use of funds (1) In general Any State that receives amounts pursuant to this section shall expend at least 30 percent of such funds within one year of the date funds become available to the grantee for obligation. (2) Priority Any State that receives amounts pursuant to this section shall distribute such amounts giving priority to entities with the greatest need and ability to deliver effective assistance in a timely manner. (3) Administrative costs Any State that receives amounts pursuant to this section may use up to 5 percent of any grant for administrative costs. (d) Rules of construction (1) In general Except as otherwise provided by this section, amounts appropriated, or amounts otherwise made available to States under this section shall be treated as though such funds were community development block grant funds under title I of the Housing and Community Development Act of 1974 (42 U.S.C. 5301 et seq.). (2) No match No matching funds shall be required in order for a State to receive any amounts under this section. (e) Authority to waive or specify alternative requirements (1) In general In administering any amounts appropriated or otherwise made available under this section, the Secretary may waive or specify alternative requirements for any provision of any statute or regulation in connection with the obligation by the Secretary or the use of funds except for requirements related to fair housing, nondiscrimination, labor standards, and the environment, upon a finding that such a waiver is necessary to expedite or facilitate the use of such funds. (2) Notice The Secretary shall provide written notice of its intent to exercise the authority to specify alternative requirements under paragraph (1) to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives not later than 5 business days before such exercise of authority occurs. (f) Technical assistance For the 2-year period following the date of enactment of this Act, the Secretary may use not more than 2 percent of the funds made available under this section for technical assistance to grantees. (g) State For purposes of this section the term State includes any State as defined in section 102 of the Housing and Community Development Act of 1974 (42 U.S.C. 5302) and the District of Columbia. 1413. Youth prevention and recovery (a) Substance abuse treatment services for children, adolescents, and young adults Section 514 of the Public Health Service Act (42 U.S.C. 290bb–7) is amended— (1) in the section heading, by striking children and adolescents and inserting children, adolescents, and young adults; (2) in subsection (a)(2), by striking children, including and inserting children, adolescents, and young adults, including; and (3) by striking children and adolescents each place it appears and inserting children, adolescents, and young adults. (b) Resource center The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use and, as appropriate, in consultation with the Secretary of Education and other agencies, shall establish a resource center to provide technical support to recipients of grants under subsection (c). (c) Youth prevention and recovery initiative (1) In general The Secretary, in consultation with the Secretary of Education, shall administer a program to provide support for communities to support the prevention of, treatment of, and recovery from, substance use disorders for children, adolescents, and young adults. (2) Definitions In this subsection: (A) Eligible entity The term eligible entity means— (i) a local educational agency that is seeking to establish or expand substance use prevention or recovery support services at one or more high schools; (ii) a State educational agency; (iii) an institution of higher education (or consortia of such institutions), which may include a recovery program at an institution of higher education; (iv) a local board or one-stop operator; (v) a nonprofit organization with appropriate expertise in providing services or programs for children, adolescents, or young adults, excluding a school; (vi) a State, political subdivision of a State, Indian Tribe, or tribal organization; or (vii) a high school or dormitory serving high school students that receives funding from the Bureau of Indian Education. (B) Evidence-based The term evidence-based has the meaning given such term in section 8101 of the Elementary and Secondary Education Act (20 U.S.C. 7801). (C) Foster care The term foster care has the meaning given such term in section 1355.20(a) of title 45, Code of Federal Regulations (or any successor regulations). (D) High school The term high school has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (E) Homeless youth The term homeless youth has the meaning given the term homeless children or youths in section 725 of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11434a); (F) Institution of higher education The term institution of higher education has the meaning given such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001) and includes a postsecondary vocational institution as defined in section 102(c) of such Act (20 U.S.C. 1002(c)). (G) Local educational agency The term local educational agency has the meaning given the term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (H) Local board; one-stop operator The terms local board and one-stop operator have the meanings given such terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102). (I) Out of School Youth The term out-of-school youth has the meaning given such term in section 129(a)(1)(B) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3164(a)(1)(B)). (J) Recovery program The term recovery program means a program— (i) to help children, adolescents, or young adults who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and (ii) that includes peer-to-peer support delivered by individuals with lived experience in recovery, and communal activities to build recovery skills and supportive social networks. (K) State Educational Agency The term State educational agency has the meaning given the term in section 8101 of the Elementary and Secondary Education Act (20 U.S.C. 7801). (3) Best practices The Secretary, in consultation with the Secretary of Education, shall— (A) identify or facilitate the development of evidence-based best practices for prevention of substance misuse and abuse by children, adolescents, and young adults, including for specific populations such as youth in foster care, homeless youth, out-of-school youth, and youth who are at risk of or have experienced trafficking that address— (i) primary prevention; (ii) appropriate recovery support services; (iii) appropriate use of medication-assisted treatment for such individuals, if applicable, and ways of overcoming barriers to the use of medication-assisted treatment in such population; and (iv) efficient and effective communication, which may include the use of social media, to maximize outreach efforts; (B) disseminate such best practices to State educational agencies, local educational agencies, schools and dormitories funded by the Bureau of Indian Education, institutions of higher education, recovery programs at institutions of higher education, local boards, one-stop operators, family and youth homeless providers, and nonprofit organizations, as appropriate; (C) conduct a rigorous evaluation of each grant funded under this subsection, particularly its impact on the indicators described in paragraph (8)(B); and (D) provide technical assistance for grantees under this subsection. (4) Grants authorized The Secretary, in consultation with the Secretary of Education, shall award 3-year grants, on a competitive basis, to eligible entities to enable such entities, in coordination with Indian Tribes, if applicable, and State agencies responsible for carrying out substance use disorder prevention and treatment programs, to carry out evidence-based programs for— (A) prevention of substance misuse and abuse by children, adolescents, and young adults, which may include primary prevention; (B) recovery support services for children, adolescents, and young adults, which may include counseling, job training, linkages to community-based services, family support groups, peer mentoring, and recovery coaching; or (C) treatment or referrals for treatment of substance use disorders, which may include the use of medication-assisted treatment, as appropriate. (5) Special consideration In awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations. (6) Application To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. Such application shall include— (A) a description of— (i) the impact of substance use disorders in the population that will be served by the grant program; (ii) how the eligible entity has solicited input from relevant stakeholders, which may include faculty, teachers, staff, families, students, and experts in substance use prevention and treatment in developing such application; (iii) the goals of the proposed project, including the intended outcomes; (iv) how the eligible entity plans to use grant funds for evidence-based activities, in accordance with this subsection to prevent, provide recovery support for, or treat substance use disorders amongst such individuals, or a combination of such activities; and (v) how the eligible entity will collaborate with relevant partners, which may include State educational agencies, local educational agencies, institutions of higher education, juvenile justice agencies, prevention and recovery support providers, local service providers, including substance use disorder treatment programs, providers of mental health services, youth serving organizations, family and youth homeless providers, child welfare agencies, and primary care providers, in carrying out the grant program; and (B) an assurance that the eligible entity will participate in the evaluation described in paragraph (3)(C). (7) Priority In awarding grants under this subsection, the Secretary shall give priority to eligible entities that propose to use grant funds for activities that meet the criteria described in subclauses (I) and (II) of section 8101(21)(A)(i) of the Elementary and Secondary Education Act (20 U.S.C. 7801(21)(A)(i)). (8) Reports to the Secretary Each eligible entity awarded a grant under this subsection shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include— (A) a description of how the eligible entity used grant funds, in accordance with this subsection, including the number of children, adolescents, and young adults reached through programming; and (B) a description, including relevant data, of how the grant program has made an impact on the intended outcomes described in paragraph (6)(A)(iii), including— (i) indicators of student success, which, if the eligible entity is an educational institution, shall include student well-being and academic achievement; (ii) substance use disorders amongst children, adolescents, and young adults, including the number of overdoses and deaths amongst children, adolescents, and young adults during the grant period; and (iii) other indicators, as the Secretary determines appropriate. (9) Report to Congress The Secretary shall, not later than October 1, 2022, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives, a report summarizing the effectiveness of the grant program under this subsection, based on the information submitted in reports required under paragraph (8). (10) Authorization of appropriations There is authorized to be appropriated such sums as may be necessary to carry out this subsection for each of fiscal years 2019 through 2023. 1414. Plans of safe care Section 105(a) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5106(a)) is amended by adding at the end the following: (7) Grants to States to improve and coordinate their response to ensure the safety, permanency, and well-being of infants affected by substance use (A) Program authorized The Secretary shall make grants to States for the purpose of assisting child welfare agencies, social services agencies, substance use disorder treatment agencies, hospitals with labor and delivery units, medical staff, public health and mental health agencies, and maternal and child health agencies to facilitate collaboration in developing, updating, implementing, and monitoring plans of safe care described in section 106(b)(2)(B)(iii). (B) Distribution of funds (i) Reservations Of the amounts appropriated under subparagraph (H), the Secretary shall reserve— (I) no more than 3 percent for the purposes described in subparagraph (G); and (II) up to 3 percent for grants to Indian Tribes and tribal organizations to address the needs of infants born with, and identified as being affected by, substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder and their families or caregivers, which to the extent practicable, shall be consistent with the uses of funds described under subparagraph (D). (ii) Allotments to States and territories The Secretary shall allot the amount appropriated under subparagraph (H) that remains after application of clause (i) to each State that applies for such a grant, in an amount equal to the sum of— (I) $500,000; and (II) an amount that bears the same relationship to any funds appropriated under subparagraph (H) and remaining after application of clause (i), as the number of live births in the State in the previous calendar year bears to the number of live births in all States in such year. (iii) Ratable reduction If the amount appropriated under subparagraph (H) is insufficient to satisfy the requirements of clause (ii), the Secretary shall ratably reduce each allotment to a State. (C) Application A State desiring a grant under this paragraph shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include— (i) a description of— (I) the impact of substance use disorder in such State, including with respect to the substance or class of substances with the highest incidence of abuse in the previous year in such State, including— (aa) the prevalence of substance use disorder in such State; (bb) the aggregate rate of births in the State of infants affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder (as determined by hospitals, insurance claims, claims submitted to the State Medicaid program, or other records), if available and to the extent practicable; and (cc) the number of infants identified, for whom a plan of safe care was developed, and for whom a referral was made for appropriate services, as reported under section 106(d)(18); (II) the challenges the State faces in developing, implementing, and monitoring plans of safe care in accordance with section 106(b)(2)(B)(iii); (III) the State’s lead agency for the grant program and how that agency will coordinate with relevant State entities and programs, including the child welfare agency, the substance use disorder treatment agency, hospitals with labor and delivery units, health care providers, the public health and mental health agencies, programs funded by the Substance Abuse and Mental Health Services Administration that provide substance use disorder treatment for women, the State Medicaid program, the State agency administering the block grant program under title V of the Social Security Act (42 U.S.C. 701 et seq.), the State agency administering the programs funded under part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431 et seq.), the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act (42 U.S.C. 711), the State judicial system, and other agencies, as determined by the Secretary, and Indian Tribes and tribal organizations, as appropriate; (IV) how the State will monitor local development and implementation of plans of safe care, in accordance with section 106(b)(2)(B)(iii)(II), including how the State will monitor to ensure plans of safe care address differences between substance use disorder and medically supervised substance use, including for the treatment of a substance use disorder; (V) how the State meets the requirements of section 1927 of the Public Health Service Act (42 U.S.C. 300x–27); (VI) how the State plans to utilize funding authorized under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.) to assist in carrying out any plan of safe care, including such funding authorized under section 471(e) of such Act (as in effect on October 1, 2018) for mental health and substance abuse prevention and treatment services and in-home parent skill-based programs and funding authorized under such section 472(j) (as in effect on October 1, 2018) for children with a parent in a licensed residential family-based treatment facility for substance abuse; and (VII) an assessment of the treatment and other services and programs available in the State, to effectively carry out any plan of safe care developed, including identification of needed treatment, and other services and programs to ensure the well-being of young children and their families affected by substance use disorder, such as programs carried out under part C of the Individuals with Disabilities Education Act and comprehensive early childhood development services and programs such as Head Start programs; (ii) a description of how the State plans to use funds for activities described in subparagraph (D) for the purposes of ensuring State compliance with requirements under clauses (ii) and (iii) of section 106(b)(2)(B); and (iii) an assurance that the State will— (I) comply with this Act and parts B and E of title IV of the Social Security Act (42 U.S.C. 621 et seq., 670 et seq.); and (II) comply with requirements to refer a child identified as substance-exposed to early intervention services as required pursuant to a grant under part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431 et seq.). (D) Uses of funds Funds awarded to a State under this paragraph may be used for the following activities, which may be carried out by the State directly, or through grants or subgrants, contracts, or cooperative agreements: (i) Improving State and local systems with respect to the development and implementation of plans of safe care, which— (I) shall include parent and caregiver engagement, as required under section 106(b)(2)(B)(iii)(I), regarding available treatment and service options, which may include resources available for pregnant, perinatal, and postnatal women; and (II) may include activities such as— (aa) developing policies, procedures, or protocols for the administration or development of evidence-based and validated screening tools for infants who may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder and pregnant, perinatal, and postnatal women whose infants may be affected by substance use withdrawal symptoms or a fetal alcohol spectrum disorder; (bb) improving assessments used to determine the needs of the infant and family; (cc) improving ongoing case management services; and (dd) improving access to treatment services, which may be prior to the pregnant woman’s delivery date. (ii) Developing policies, procedures, or protocols in consultation and coordination with health professionals, public and private health facilities, and substance use disorder treatment agencies to ensure that— (I) appropriate notification to child protective services is made in a timely manner; (II) a plan of safe care is in place, in accordance with section 106(b)(2)(B)(iii), before the infant is discharged from the birth or health care facility; and (III) such health and related agency professionals are trained on how to follow such protocols and are aware of the supports that may be provided under a plan of safe care. (iii) Training health professionals and health system leaders, child welfare workers, substance use disorder treatment agencies, and other related professionals such as home visiting agency staff and law enforcement in relevant topics including— (I) State mandatory reporting laws and the referral and process requirements for notification to child protective services when child abuse or neglect reporting is not mandated; (II) the co-occurrence of pregnancy and substance use disorder, and implications of prenatal exposure; (III) the clinical guidance about treating substance use disorder in pregnant and postpartum women; (IV) appropriate screening and interventions for infants affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder and the requirements under section 106(b)(2)(B)(iii); and (V) appropriate multigenerational strategies to address the mental health needs of the parent and child together. (iv) Establishing partnerships, agreements, or memoranda of understanding between the lead agency and health professionals, health facilities, child welfare professionals, juvenile and family court judges, substance use and mental disorder treatment programs, early childhood education programs, and maternal and child health and early intervention professionals, including home visiting providers, peer-to-peer recovery programs such as parent mentoring programs, and housing agencies to facilitate the implementation of, and compliance with section 106(b)(2) and clause (ii) of this subparagraph, in areas which may include— (I) developing a comprehensive, multi-disciplinary assessment and intervention process for infants, pregnant women, and their families who are affected by substance use disorder, withdrawal symptoms, or a fetal alcohol spectrum disorder, that includes meaningful engagement with and takes into account the unique needs of each family and addresses differences between medically supervised substance use, including for the treatment of substance use disorder, and substance use disorder; (II) ensuring that treatment approaches for serving infants, pregnant women, and perinatal and postnatal women whose infants may be affected by substance use, withdrawal symptoms, or a fetal alcohol spectrum disorder, are designed to, where appropriate, keep infants with their mothers during both inpatient and outpatient treatment; and (III) increasing access to all evidence-based medication-assisted treatment approved by the Food and Drug Administration, behavioral therapy, and counseling services for the treatment of substance use disorders, as appropriate. (v) Developing and updating systems of technology for improved data collection and monitoring under section 106(b)(2)(B)(iii), including existing electronic medical records, to measure the outcomes achieved through the plans of safe care, including monitoring systems to meet the requirements of this Act and submission of performance measures. (E) Reporting Each State that receives funds under this paragraph, for each year such funds are received, shall submit a report to the Secretary, disaggregated by geographic location, economic status, and major racial and ethnic groups, except that such disaggregation shall not be required if the results would reveal personally identifiable information on, with respect to infants identified under section 106(b)(2)(B)(ii)— (i) the number who experienced removal associated with parental substance use; (ii) the number who experienced removal and subsequently are reunified with parents, and the length of time between such removal and reunification; (iii) the number who are referred to community providers without a child protection case; (iv) the number who receive services while in the care of their birth parents; (v) the number who receive post-reunification services within 1 year after a reunification has occurred; and (vi) the number who experienced a return to out-of-home care within 1 year after reunification. (F) Secretary’s report to congress The Secretary shall submit an annual report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Education and the Workforce and the Committee on Appropriations of the House of Representatives that includes the information described in subparagraph (E) and recommendations or observations on the challenges, successes, and lessons derived from implementation of the grant program. (G) Reservation of funds The Secretary shall use the amount reserved under subparagraph (B)(i)(I) for the purposes of— (i) providing technical assistance, including programs of in-depth technical assistance, to additional States, territories, and Indian Tribes and tribal organizations in accordance with the substance-exposed infant initiative developed by the National Center on Substance Abuse and Child Welfare; (ii) issuing guidance on the requirements of this Act with respect to infants born with and identified as being affected by substance use or withdrawal symptoms or fetal alcohol spectrum disorder, as described in clauses (ii) and (iii) of section 106(b)(2)(B), including by— (I) clarifying key terms; and (II) disseminating best practices on implementation of plans of safe care, on such topics as differential response, collaboration and coordination, and identification and delivery of services for different populations; (iii) supporting State efforts to develop information technology systems to manage plans of safe care; and (iv) preparing the Secretary’s report to Congress described in subparagraph (F). (H) Authorization of appropriations To carry out the program under this paragraph, there is authorized to be appropriated $60,000,000 for each of fiscal years 2019 through 2023. . 1415. Regulations relating to special registration for telemedicine Section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) is amended by striking paragraph (2) and inserting the following: (2) Regulations (A) In general Not later than 1 year after the date of enactment of the Opioid Crisis Response Act of 2018, in consultation with the Secretary, and in accordance with the procedure described in subparagraph (B), the Attorney General shall promulgate final regulations specifying— (i) the limited circumstances in which a special registration under this subsection may be issued; and (ii) the procedure for obtaining a special registration under this subsection. (B) Procedure In promulgating final regulations under subparagraph (A), the Attorney General shall— (i) issue a notice of proposed rulemaking that includes a copy of the proposed regulations; (ii) provide a period of not less than 60 days for comments on the proposed regulations; (iii) finalize the proposed regulation not later than 6 months after the close of the comment period; and (iv) publish the final regulations not later than 30 days before the effective date of the final regulations. . 1416. National Health Service Corps behavioral and mental health professionals providing obligated service in schools and other community-based settings Subpart III of part D of title III of the Public Health Service Act (42 U.S.C. 254l et seq.) is amended by adding at the end the following: 338N. Behavioral and mental health professionals providing obligated service in schools and other community-based settings (a) Schools and community-based settings An entity to which a participant in the Scholarship Program or the Loan Repayment Program (referred to in this section as a participant) is assigned under section 333 may direct such participant to provide service as a behavioral or mental health professional at a school or other community-based setting located in a health professional shortage area. (b) Obligated service (1) In general Any service described in subsection (a) that a participant provides may count towards such participant's completion of any obligated service requirements under the Scholarship Program or the Loan Repayment Program, subject to any limitation imposed under paragraph (2). (2) Limitation The Secretary may impose a limitation on the number of hours of service described in subsection (a) that a participant may credit towards completing obligated service requirements, provided that the limitation allows a member to credit service described in subsection (a) for not less than 50 percent of the total hours required to complete such obligated service requirements. (c) Rule of construction The authorization under subsection (a) shall be notwithstanding any other provision of this subpart or subpart II. . 1417. Loan repayment for substance use disorder treatment providers (a) Loan repayment for substance use treatment providers The Secretary shall enter into contracts under section 338B of the Public Health Service Act (42 U.S.C. 254l–1) with eligible health professionals providing substance use disorder treatment services in substance use disorder treatment facilities, as defined by the Secretary. (b) Provision of substance use disorder treatment In carrying out the activities described in subsection (a)— (1) each such facility shall be located in or serving a mental health professional shortage area designated under section 332 of the Public Health Service Act (42 U.S.C. 254e), or, as the Secretary determines appropriate, an area with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate; (2) section 331(a)(3)(D) of such Act (42 U.S.C. 254d(a)(3)(D)) shall be applied as if the term primary health services includes health services regarding substance use disorder treatment and infections associated with illicit drug use; (3) section 331(a)(3)(E)(i) of such Act (42 U.S.C. 254d(a)(3)(E)(i)) shall be applied as if the term behavioral and mental health professionals includes master's level, licensed substance use disorder treatment counselors, and other relevant professionals or paraprofessionals, as the Secretary determines appropriate; and (4) such professionals and facilities shall provide— (A) directly, or through the use of telehealth technology, and pursuant to Federal and State law, counseling by a program counselor or other certified professional who is licensed and qualified by education, training, or experience to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan for the patient, and to monitor progress; and (B) medication-assisted treatment, including, to the extent practicable, all drugs approved by the Food and Drug Administration to treat substance use disorders, pursuant to Federal and State law. (c) Authorization of appropriations There is authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2023. 1418. Protecting moms and infants (a) Report (1) In general Not later than 60 days after the date of enactment of this Act, the Secretary shall submit to the appropriate committees of Congress and make available to the public on the internet website of the Department of Health and Human Services a report regarding the implementation of the recommendations in the strategy relating to prenatal opioid use, including neonatal abstinence syndrome, developed pursuant to section 2 of the Protecting Our Infants Act of 2015 (Public Law 114–91). Such report shall include— (A) an update on the implementation of the recommendations in the strategy, including information regarding the agencies involved in the implementation; and (B) information on additional funding or authority the Secretary requires, if any, to implement the strategy, which may include authorities needed to coordinate implementation of such strategy across the Department of Health and Human Services. (2) Periodic updates The Secretary shall periodically update the report under paragraph (1). (b) Residential treatment programs for pregnant and postpartum women Section 508(s) of the Public Health Service Act (42 U.S.C. 290bb–1(s)) is amended by striking $16,900,000 for each of fiscal years 2017 through 2021 and inserting $29,931,000 for each of fiscal years 2019 through 2023. 1419. Early interventions for pregnant women and infants (a) Development of educational materials by Center for Substance Abuse Prevention Section 515(b) of the Public Health Service Act (42 U.S.C. 290bb–21(b)) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting ; and; and (3) by adding at the end the following: (15) in cooperation with relevant stakeholders and the Director of the Centers for Disease Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared decisionmaking regarding pain management during pregnancy. . (b) Guidelines and recommendations by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)) is amended— (1) in paragraph (13), by striking and at the end; (2) in paragraph (14), by striking the period at the end and inserting a semicolon; and (3) by adding at the end the following: (15) in cooperation with the Secretary, implement and disseminate, as appropriate, the recommendations in the report entitled Protecting Our Infants Act: Final Strategy issued by the Department of Health and Human Services in 2017; and . (c) Support of partnerships by Center for Substance Abuse Treatment Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)), as amended by subsection (b), is further amended by adding at the end the following: (16) in cooperation with relevant stakeholders, support public-private partnerships to assist with education about, and support with respect to, substance use disorder for pregnant women and health care providers who treat pregnant women and babies. . 1420. Report on investigations regarding parity in mental health and substance use disorder benefits (a) In general Section 13003 of the 21st Century Cures Act (Public Law 114–255) is amended— (1) in subsection (a), by striking with findings of any serious violation regarding and inserting concerning; and (2) in subsection (b)(1)— (A) by inserting complaints received and number of before closed; and (B) by inserting before the period , and, for each such investigation closed, which agency conducted the investigation, whether the health plan that is the subject of the investigation is fully insured or not fully insured and a summary of any coordination between the applicable State regulators and the Department of Labor, the Department of Health and Human Services, or the Department of the Treasury, and references to any guidance provided by the agencies addressing the category of violation committed. (b) Applicability The amendments made by subsection (a) shall apply with respect to the second annual report required under such section 13003 and each such annual report thereafter. E Prevention 1501. Study on prescribing limits Not later than 2 years after the date of enactment of this Act, the Secretary, in consultation with the Attorney General, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of Federal and State laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. Such report shall address— (1) the impact of such limits on— (A) the incidence and prevalence of overdose related to prescription opioids; (B) the incidence and prevalence of overdose related to illicit opioids; (C) the prevalence of opioid use disorders; (D) medically appropriate use of, and access to, opioids, including any impact on travel expenses and pain management outcomes for patients, whether such limits are associated with significantly higher rates of negative health outcomes, including suicide, and whether the impact of such limits differs based on the clinical indication for which opioids are prescribed; (2) whether such limits lead to a significant increase in burden for prescribers of opioids or prescribers of treatments for opioid use disorder, including any impact on patient access to treatment, and whether any such burden is mitigated by any factors such as electronic prescribing or telemedicine; and (3) the impact of such limits on diversion or misuse of any controlled substance in schedule II, III, or IV of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)). 1502. Programs for health care workforce (a) Program for education and training in pain care Section 759 of the Public Health Service Act (42 U.S.C. 294i) is amended— (1) in subsection (a), by striking hospices, and other public and private entities and inserting hospices, tribal health programs (as defined in section 4 of the Indian Health Care Improvement Act), and other public and nonprofit private entities; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking award may be made under subsection (a) only if the applicant for the award agrees that the program carried out with the award will include and inserting entity receiving an award under this section shall develop a comprehensive education and training plan that includes; (B) in paragraph (1)— (i) by inserting preventing, after diagnosing,; and (ii) by inserting non-addictive medical products and non-pharmacologic treatments and after including; (C) in paragraph (2)— (i) by inserting Federal, State, and local after applicable; and (ii) by striking the degree to which and all that follows through effective pain care and inserting opioids; (D) in paragraph (3), by inserting , integrated, evidence-based pain management, and, as appropriate, non-pharmacotherapy before the semicolon; (E) in paragraph (4), by striking ; and and inserting ;; and (F) by striking paragraph (5) and inserting the following: (5) recent findings, developments, and advancements in pain care research and the provision of pain care, which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which may include best practices related to screening for opioid use disorders, training on screening, brief intervention, and referral to treatment), and safe disposal options for prescription medications (including such options provided by law enforcement or other innovative deactivation mechanisms). ; (3) in subsection (d), by inserting prevention, after diagnosis,; and (4) in subsection (e), by striking 2010 through 2012 and inserting 2019 through 2023. (b) Mental and behavioral health education and training program Section 756(a) of the Public Health Service Act (42 U.S.C. 294e–1(a)) is amended— (1) in paragraph (1), by inserting , trauma, after focus on child and adolescent mental health; and (2) in paragraphs (2) and (3), by inserting trauma-informed care and before substance use disorder prevention and treatment services. 1503. Education and awareness campaigns Section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198) is amended— (1) by amending subsection (a) to read as follows: (a) In general The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the heads of other departments and agencies, shall advance education and awareness regarding the risks related to misuse and abuse of opioids, as appropriate, which may include developing or improving existing programs, conducting activities, and awarding grants that advance the education and awareness of— (1) the public, including patients and consumers; (2) patients, consumers, and other appropriate members of the public, regarding such risks related to unused opioids and the dispensing options under section 309(f) of the Controlled Substances Act, as applicable; (3) providers, which may include— (A) providing for continuing education on appropriate prescribing practices; (B) education related to applicable State or local prescriber limit laws, information on the use of non-addictive alternatives for pain management, and the use of overdose reversal drugs, as appropriate; (C) disseminating and improving the use of evidence-based opioid prescribing guidelines across relevant health care settings, as appropriate, and updating guidelines as necessary; (D) implementing strategies, such as best practices, to encourage and facilitate the use of prescriber guidelines, in accordance with State and local law; (E) disseminating information to providers about prescribing options for controlled substances, including such options under section 309(f) of the Controlled Substances Act, as applicable; and (F) disseminating information, as appropriate, on the National Pain Strategy developed by or in consultation with the Assistant Secretary for Health; and (4) other appropriate entities. ; and (2) in subsection (b)— (A) by striking opioid abuse each place such term appears and inserting opioid misuse and abuse; and (B) in paragraph (2), by striking safe disposal of prescription medications and other and inserting non-addictive treatment options, safe disposal options for prescription medications, and other applicable. 1504. Enhanced controlled substance overdoses data collection, analysis, and dissemination Part J of title III of the Public Health Service Act is amended by inserting after section 392 (42 U.S.C. 280b–1) the following: 392A. Enhanced controlled substance overdoses data collection, analysis, and dissemination (a) In general The Director of the Centers for Disease Control and Prevention, using the authority provided to the Director under section 392, may— (1) to the extent practicable, carry out and expand any controlled substance overdose data collection, analysis, and dissemination activity described in subsection (b); (2) provide training and technical assistance to States, localities, and Indian Tribes for the purpose of carrying out any such activity; and (3) award grants to States, localities, and Indian Tribes for the purpose of carrying out any such activity. (b) Controlled substance overdose data collection and analysis activities A controlled substance overdose data collection, analysis, and dissemination activity described in this subsection is any of the following activities: (1) Improving the timeliness of reporting aggregate data to the public, including data on fatal and nonfatal controlled substance overdoses. (2) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on such overdoses from appropriate sources such as toxicology reports, autopsy reports, death scene investigations, and emergency department services. (3) Modernizing the system for coding causes of death related to controlled substance overdoses to use an electronic-based system. (4) Using data to help identify risk factors associated with controlled substance overdoses, including the delivery of certain health care services. (5) Supporting entities involved in reporting information on controlled substance overdoses, such as coroners and medical examiners, to improve accurate testing and standardized reporting of causes and contributing factors of such overdoses, and analysis of various opioid analogues to controlled substance overdoses. (6) Working to enable and encourage the access, exchange, and use of data regarding controlled substances overdoses among data sources and entities. (c) Definitions In this section— (1) the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act; and (2) the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act. . 1505. Preventing overdoses of controlled substances Part J of title III of the Public Health Service Act (42 U.S.C. 280b et seq.), as amended by section 504, is further amended by inserting after section 392A the following: 392B. Preventing overdoses of controlled substances (a) Prevention activities (1) In general The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director), using the authority provided to the Director under section 392, may— (A) to the extent practicable, carry out and expand any prevention activity described in paragraph (2); (B) provide training and technical assistance to States, localities, and Indian Tribes to carry out any such activity; and (C) award grants to States, localities, and Indian Tribes for the purpose of carrying out any such activity. (2) Prevention activities A prevention activity described in this paragraph is an activity to improve the efficiency and use of a new or currently operating prescription drug monitoring program, such as— (A) encouraging all authorized users (as specified by the State or other entity) to register with and use the program; (B) enabling such users to access any data updates in as close to real-time as practicable; (C) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing or dispensing practices relating to such substances; (D) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identified, aggregate reports based on such analysis to State public health agencies, State alcohol and drug agencies, State licensing boards, and other appropriate State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug monitoring program and not containing any protected health information, to prevent inappropriate prescribing, drug diversion, or abuse and misuse of controlled substances, and to facilitate better coordination among agencies; (E) enhancing interoperability between the program and any health information technology (including certified health information technology), including by integrating program data into such technology; (F) updating program capabilities to respond to technological innovation for purposes of appropriately addressing the occurrence and evolution of controlled substance overdoses; (G) developing or enhancing data exchange with other sources such as the Medicaid agency, the Medicare program, pharmacy benefit managers, coroners’ reports, and workers’ compensation data; (H) facilitating and encouraging data exchange between the program and the prescription drug monitoring programs of other States; (I) enhancing data collection and quality, including improving patient matching and proactively monitoring data quality; and (J) providing prescriber and dispenser practice tools, including prescriber practice insight reports for practitioners to review their prescribing patterns in comparison to such patters of other practitioners in the specialty. (b) Additional grants The Director may award grants to States, localities, and Indian Tribes— (1) to carry out innovative projects for grantees to rapidly respond to controlled substance misuse, abuse, and overdoses, including changes in patterns of controlled substance use; and (2) for any other evidence-based activity for preventing controlled substance misuse, abuse, and overdoses as the Director determines appropriate. (c) Research The Director, in coordination with the Assistant Secretary for Mental Health and Substance Use and the National Mental Health and Substance Use Policy Laboratory established under section 501A, as appropriate and applicable, may conduct studies and evaluations to address substance use disorders, including preventing substance use disorders or other related topics the Director determines appropriate. (d) Public and prescriber education Pursuant to section 102 of the Comprehensive Addiction and Recovery Act of 2016, the Director may advance the education and awareness of prescribers and the public regarding the risk of abuse and misuse of prescription opioids. (e) Definitions In this section— (1) the term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act; and (2) the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act. (f) Authorization of appropriations For purposes of carrying out this section, section 392A of this Act, and section 102 of the Comprehensive Addiction and Recovery Act of 2016, there is authorized to be appropriated $486,000,000 for each of fiscal years 2019 through 2024. . 1506. CDC surveillance and data collection for child, youth, and adult trauma (a) Data collection The Director of the Centers for Disease Control and Prevention (referred to in this section as the Director) may, in cooperation with the States, collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, and other relevant public health surveys or questionnaires. (b) Timing The collection of data under subsection (a) may occur in fiscal year 2019 and every 2 years thereafter. (c) Data from rural areas The Director shall encourage each State that participates in collecting and reporting data under subsection (a) to collect and report data from tribal and rural areas within such State, in order to generate a statistically reliable representation of such areas. (d) Data from tribal areas The Director may, in cooperation with Indian Tribes and pursuant to a written request from an Indian Tribe, provide technical assistance to such Indian Tribe to collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, or another relevant public health survey or questionnaire. (e) Authorization of appropriations To carry out this section, there is authorized to be appropriated such sums as may be necessary for the period of fiscal years 2019 through 2021. 1507. Reauthorization of NASPER Section 399O of the Public Health Service Act (42 U.S.C. 280g–3) is amended— (1) in subsection (a)— (A) in paragraph (1), in the matter preceding subparagraph (A), by striking in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and Prevention and inserting in coordination with the Director of the Centers for Disease Control and the heads of other departments and agencies as appropriate; and (B) by adding at the end the following: (4) States and local governments (A) In general In the case of a State that does not have a prescription drug monitoring program, a county or other unit of local government within the State that has a prescription drug monitoring program shall be treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1). (B) Plan for interoperability For purposes of meeting the interoperability requirements under subsection (c)(3), a county or other unit of local government shall submit a plan outlining the methods such county or unit of local government will use to ensure the capability of data sharing with other counties and units of local government within the State and with other States, as applicable. ; (2) in subsection (c)— (A) in paragraph (1)(A)(iii)— (i) by inserting as such standards become available, after interoperability standards,; and (ii) by striking generated or identified by the Secretary or his or her designee and inserting recognized by the Office of the National Coordinator for Health Information Technology; and (B) in paragraph (3)(A), by inserting including electronic health records, after technology systems,; (3) in subsection (d)(1), by striking not later than 1 week after the date of such dispensing and inserting in as close to real time as practicable; (4) in subsection (f)— (A) in paragraph (1)(D), by striking medicaid and inserting Medicaid; and (B) in paragraph (2)— (i) in subparagraph (A), by striking and at the end; (ii) in subparagraph (B), by striking the period and inserting a semicolon; and (iii) by adding at the end the following: (C) may conduct analyses of controlled substance program data for purposes of providing appropriate State agencies with aggregate reports based on such analyses in as close to real-time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse, addiction, overdose, and other aggregate information, as appropriate and in compliance with applicable Federal and State laws and provided that such reports shall not include protected health information; and (D) may access information about prescriptions, such as claims data, to ensure that such prescribing and dispensing history is updated in as close to real-time as practicable, in compliance with applicable Federal and State laws and provided that such information shall not include protected health information. ; (5) in subsection (i), by inserting , in collaboration with the National Coordinator for Health Information Technology and the Director of the National Institute of Standards and Technology, after The Secretary; and (6) in subsection (n), by striking 2021 and inserting 2026. 1508. Jessie’s law (a) Best practices (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding— (A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient; (B) what constitutes the patient’s request for the purpose described in subparagraph (A); and (C) the process and methods by which the information should be so displayed. (2) Dissemination The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies. (b) Requirements In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following: (1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder. (2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications. (3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers. (4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations. (5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations. (6) All applicable Federal and State laws and regulations. 1509. Development and dissemination of model training programs for substance use disorder patient records (a) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary, in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (1) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) for the confidentiality of patient records. (2) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in paragraph (1). (b) Requirements The model programs and materials described in paragraphs (1) and (2) of subsection (a) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (1) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (2) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (3) notify and involve families and caregivers when individuals experience an overdose. (c) Periodic updates The Secretary shall— (1) periodically review and update the model program and materials identified or developed under subsection (a); and (2) disseminate such updated programs and materials to the individuals described in subsection (a)(1). (d) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2019 through 2023. 1510. Communication with families during emergencies (a) Promoting Awareness of Authorized Disclosures during Emergencies The Secretary shall annually notify health care providers regarding permitted disclosures during emergencies, including overdoses, of certain health information to families and caregivers under Federal health care privacy laws and regulations. (b) Use of material For the purposes of carrying out subsection (a), the Secretary may use material produced under section 1509 of this Act or under section 11004 of the 21st Century Cures Act (42 U.S.C. 1320d–2 note). 1511. Prenatal and postnatal health Section 317L of the Public Health Service Act (42 U.S.C. 247b–13) is amended— (1) in subsection (a)— (A) by amending paragraph (1) to read as follows: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and substance abuse and misuse, including— (A) data on— (i) the incidence, prevalence, and implications of such activities; and (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and (B) to inform such analysis, additional information or data on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, as appropriate; ; (B) in paragraph (2)— (i) by striking prevention of and inserting prevention and long-term outcomes associated with; and (ii) by striking illegal drug use and inserting substance abuse and misuse; (C) in paragraph (3), by striking and cessation programs; and and inserting , treatment, and cessation programs;; (D) in paragraph (4), by striking illegal drug use. and inserting substance abuse and misuse; and; and (E) by adding at the end the following: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of— (A) long-term outcomes of children affected by neonatal abstinence syndrome; (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and (C) relevant studies, evaluations, or information the Secretary determines to be appropriate. ; (2) in subsection (b), by inserting tribal entities, after local governments,; (3) by redesignating subsection (c) as subsection (d); (4) by inserting after subsection (b) the following: (c) Coordinating activities To carry out this section, the Secretary may— (1) provide technical and consultative assistance to entities receiving grants under subsection (b); (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention; (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and (4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology. ; and (5) in subsection (d), as so redesignated, by striking 2001 through 2005 and inserting 2019 through 2023. 1512. Surveillance and education regarding infections associated with illicit drug use and other risk factors Section 317N of the Public Health Service Act (42 U.S.C. 247b–15) is amended— (1) by amending the section heading to read as follows: Surveillance and education regarding infections associated with illicit drug use and other risk factors; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting activities before the colon; (B) in paragraph (1)— (i) by inserting or maintaining after implementing; (ii) by striking hepatitis C virus infection (in this section referred to as HCV infection) and inserting infections commonly associated with illicit drug use, which may include viral hepatitis, human immunodeficiency virus, and infective endocarditis,; and (iii) by striking such infection and all that follows through the period at the end and inserting such infections, which may include the reporting of cases of such infections.; (C) in paragraph (2), by striking HCV infection and all that follows through the period at the end and inserting infections as a result of illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.; (D) in paragraphs (4) and (5), by striking HCV infection each place such term appears and inserting infections described in paragraph (1); and (E) in paragraph (5), by striking pediatricians and other primary care physicians, and obstetricians and gynecologists and inserting substance use disorder treatment providers, pediatricians, other primary care providers, and obstetrician-gynecologists; (3) in subsection (b)— (A) by striking directly and and inserting directly or; and (B) by striking hepatitis C, and all that follows through the period at the end and inserting infections described in subsection (a)(1).; and (4) in subsection (c), by striking such sums as may be necessary for each of the fiscal years 2001 through 2005 and inserting $40,000,000 for each of fiscal years 2019 through 2023. 1513. Task force to develop best practices for trauma-informed identification, referral, and support (a) Establishment There is established a task force, to be known as the Interagency Task Force on Trauma-Informed Care (in this section referred to as the task force) that shall identify, evaluate, and make recommendations regarding best practices with respect to children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma. (b) Membership (1) Composition The task force shall be composed of the heads of the following Federal departments and agencies, or their designees: (A) The Centers for Medicare & Medicaid Services. (B) The Substance Abuse and Mental Health Services Administration. (C) The Agency for Healthcare Research and Quality. (D) The Centers for Disease Control and Prevention. (E) The Indian Health Service. (F) The Department of Veterans Affairs. (G) The National Institutes of Health. (H) The Food and Drug Administration. (I) The Health Resources and Services Administration. (J) The Department of Defense. (K) The Office of Minority Health. (L) The Administration for Children and Families. (M) The Office of the Assistant Secretary for Planning and Evaluation. (N) The Office for Civil Rights of the Department of Health and Human Services. (O) The Office of Juvenile Justice and Delinquency Prevention of the Department of Justice. (P) The Office of Community Oriented Policing Services of the Department of Justice. (Q) The Office on Violence Against Women of the Department of Justice. (R) The National Center for Education Evaluation and Regional Assistance of the Department of Education. (S) The National Center for Special Education Research of the Institute of Education Science. (T) The Office of Elementary and Secondary Education of the Department of Education. (U) The Office for Civil Rights of the Department of Education. (V) The Office of Special Education and Rehabilitative Services of the Department of Education. (W) The Bureau of Indian Affairs of the Department of the Interior. (X) The Veterans Health Administration of the Department of Veterans Affairs. (Y) The Office of Special Needs Assistance Programs of the Department of Housing and Urban Development. (Z) The Office of Head Start of the Administration for Children and Families. (AA) The Children’s Bureau of the Administration for Children and Families. (BB) The Bureau of Indian Education of the Department of the Interior. (CC) Such other Federal agencies as the Secretaries determine to be appropriate. (2) Date of appointments The heads of Federal departments and agencies shall appoint the corresponding members of the task force not later than 6 months after the date of enactment of this Act. (3) Chairperson The task force shall be chaired by the Assistant Secretary for Mental Health and Substance Use. (c) Task force duties The task force shall— (1) solicit input from stakeholders, including frontline service providers, educators, mental health professionals, researchers, experts in infant, child, and youth trauma, child welfare professionals, and the public, in order to inform the activities under paragraph (2); and (2) identify, evaluate, make recommendations, and update such recommendations not less than annually, to the general public, the Secretary of Education, the Secretary of Health and Human Services, the Secretary of Labor, the Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress regarding— (A) a set of evidence-based, evidence-informed, and promising best practices with respect to— (i) the identification of infants, children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (ii) the expeditious referral to and implementation of trauma-informed practices and supports that prevent and mitigate the effects of trauma; (B) a national strategy on how the task force and member agencies will collaborate, prioritize options for, and implement a coordinated approach which may include data sharing and the awarding of grants that support infants, children, and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (C) existing Federal authorities at the Department of Education, Department of Health and Human Services, Department of Justice, Department of Labor, Department of the Interior, and other relevant agencies, and specific Federal grant programs to disseminate best practices on, provide training in, or deliver services through, trauma-informed practices, and disseminate such information— (i) in writing to relevant program offices at such agencies to encourage grant applicants in writing to use such funds, where appropriate, for trauma-informed practices; and (ii) to the general public through the internet website of the task force. (d) Best practices In identifying, evaluating, and recommending the set of best practices under subsection (c), the task force shall— (1) include guidelines for providing professional development for front-line services providers, including school personnel, early childhood education program providers, providers from child- or youth-serving organizations, housing and homeless providers, primary and behavioral health care providers, child welfare and social services providers, juvenile and family court personnel, health care providers, individuals who are mandatory reporters of child abuse or neglect, trained nonclinical providers (including peer mentors and clergy), and first responders, in— (A) understanding and identifying early signs and risk factors of trauma in infants, children, and youth, and their families as appropriate, including through screening processes; (B) providing practices to prevent and mitigate the impact of trauma, including by fostering safe and stable environments and relationships; and (C) developing and implementing policies, procedures, or systems that— (i) are designed to quickly refer infants, children, youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma to the appropriate trauma-informed screening and support, including age-appropriate treatment, and to ensure such infants, children, youth, and family members receive such support; (ii) utilize and develop partnerships with early childhood education programs, local social services organizations, such as organizations serving youth, and clinical mental health or health care service providers with expertise in providing support services (including age-appropriate trauma-informed and evidence-based treatment) aimed at preventing or mitigating the effects of trauma; (iii) educate children and youth to— (I) understand and identify the signs, effects, or symptoms of trauma; and (II) build the resilience and coping skills to mitigate the effects of experiencing trauma; (iv) promote and support multi-generational practices that assist parents, foster parents, and kinship and other caregivers in accessing resources related to, and developing environments conducive to, the prevention and mitigation of trauma; and (v) collect and utilize data from screenings, referrals, or the provision of services and supports to evaluate and improve processes for trauma-informed support and outcomes that are culturally sensitive, linguistically appropriate, and specific to age ranges and sex, as applicable; and (2) recommend best practices that are designed to avoid unwarranted custody loss or criminal penalties for parents or guardians in connection with infants, children, and youth who have experienced or are at risk of experiencing trauma. (e) Operating plan Not later than 1 year after the date of enactment of this Act, the task force shall hold the first meeting. Not later than 2 years after such date of enactment, the task force shall submit to the Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and Congress an operating plan for carrying out the activities of the task force described in subsection (c)(2). Such operating plan shall include— (1) a list of specific activities that the task force plans to carry out for purposes of carrying out duties described in subsection (c)(2), which may include public engagement; (2) a plan for carrying out the activities under subsection (c)(2); (3) a list of members of the task force and other individuals who are not members of the task force that may be consulted to carry out such activities; (4) an explanation of Federal agency involvement and coordination needed to carry out such activities, including any statutory or regulatory barriers to such coordination; (5) a budget for carrying out such activities; and (6) other information that the task force determines appropriate. (f) Final report Not later than 3 years after the date of the first meeting of the task force, the task force shall submit to the general public, Secretary of Education, Secretary of Health and Human Services, Secretary of Labor, Secretary of the Interior, the Attorney General, and other relevant cabinet Secretaries, and Congress, a final report containing all of the findings and recommendations required under this section. (g) Definition In this section, the term early childhood education program has the meaning given such term in section 103 of the Higher Education Act of 1965 (20 U.S.C. 1003). (h) Authorization of appropriations To carry out this section, there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2019 through 2022. (i) Sunset The task force shall on the date that is 60 days after the submission of the final report under subsection (f), but not later than September 30, 2022. 1514. Grants to improve trauma support services and mental health care for children and youth in educational settings (a) Grants, contracts, and cooperative agreements authorized The Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use, is authorized to award grants to, or enter into contracts or cooperative agreements with, State educational agencies, local educational agencies, Head Start agencies (including Early Head Start agencies), State or local agencies that administer public preschool programs, Indian Tribes or their tribal educational agencies, a school operated by the Bureau of Indian Education, a Regional Corporation (as defined in section 3 of the Alaska Native Claims Settlement Act (43 U.S.C. 1602)), or a Native Hawaiian educational organization (as defined in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517)), for the purpose of increasing student access to evidence-based trauma support services and mental health care by developing innovative initiatives, activities, or programs to link local school systems with local trauma-informed support and mental health systems, including those under the Indian Health Service. (b) Duration With respect to a grant, contract, or cooperative agreement awarded or entered into under this section, the period during which payments under such grant, contract or agreement are made to the recipient may not exceed 4 years. (c) Use of funds An entity that receives a grant, contract, or cooperative agreement under this section shall use amounts made available through such grant, contract, or cooperative agreement for evidence-based activities, which shall include any of the following: (1) Collaborative efforts between school-based service systems and trauma-informed support and mental health service systems to provide, develop, or improve prevention, screening, referral, and treatment and support services to students, such as by providing universal trauma screenings to identify students in need of specialized support. (2) To implement schoolwide multi-tiered positive behavioral interventions and supports, or other trauma-informed models of support. (3) To provide professional development to teachers, teacher assistants, school leaders, specialized instructional support personnel, and mental health professionals that— (A) fosters safe and stable learning environments that prevent and mitigate the effects of trauma, including through social and emotional learning; (B) improves school capacity to identify, refer, and provide services to students in need of trauma support or behavioral health services; or (C) reflects the best practices developed by the Interagency Task Force on Trauma-Informed Care established under section 513. (4) To create or enhance services at a full-service community school that focuses on trauma-informed supports, which may include establishing a school-site advisory team, managing, coordinating, or delivering pipeline services, hiring a full-time site coordinator, or other activities consistent with section 4625 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7275). (5) Engaging families and communities in efforts to increase awareness of child and youth trauma, which may include sharing best practices with law enforcement regarding trauma-informed care and working with mental health professionals to provide interventions, as well as longer term coordinated care within the community for children and youth who have experienced trauma and their families. (6) To provide technical assistance to school systems and mental health agencies. (7) To evaluate the effectiveness of the program carried out under this section in increasing student access to evidence-based trauma support services and mental health care. (d) Applications To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity described in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include the following: (1) A description of the innovative initiatives, activities, or programs to be funded under the grant, contract, or cooperative agreement, including how such program will increase access to evidence-based trauma support services and mental health care for students, and, as applicable, the families of such students. (2) A description of how the program will provide linguistically appropriate and culturally competent services. (3) A description of how the program will support students and the school in improving the school climate in order to support an environment conducive to learning. (4) An assurance that— (A) persons providing services under the grant, contract, or cooperative agreement are adequately trained to provide such services; and (B) teachers, school leaders, administrators, specialized instructional support personnel, representatives of local Indian Tribes or tribal organizations as appropriate, other school personnel, and parents or guardians of students participating in services under this section will be engaged and involved in the design and implementation of the services. (5) A description of how the applicant will support and integrate existing school-based services with the program in order to provide mental health services for students, as appropriate. (e) Interagency agreements (1) Designation of lead agency A recipient of a grant, contract, or cooperative agreement under this section shall designate a lead agency to direct the establishment of an interagency agreement among local educational agencies, agencies responsible for early childhood education programs, juvenile justice authorities, mental health agencies, child welfare agencies, and other relevant entities in the State or Indian Tribe, in collaboration with local entities. (2) Contents The interagency agreement shall ensure the provision of the services described in subsection (c), specifying with respect to each agency, authority, or entity— (A) the financial responsibility for the services; (B) the conditions and terms of responsibility for the services, including quality, accountability, and coordination of the services; and (C) the conditions and terms of reimbursement among the agencies, authorities, or entities that are parties to the interagency agreement, including procedures for dispute resolution. (f) Evaluation The Secretary shall reserve not to exceed 3 percent of the funds made available under subsection (l) for each fiscal year to— (1) conduct a rigorous, independent evaluation of the activities funded under this section; and (2) disseminate and promote the utilization of evidence-based practices regarding trauma support services and mental health care. (g) Distribution of awards The Secretary shall ensure that grants, contracts, and cooperative agreements awarded or entered into under this section are equitably distributed among the geographical regions of the United States and among tribal, urban, suburban, and rural populations. (h) Rule of construction Nothing in this section shall be construed— (1) to prohibit an entity involved with a program carried out under this section from reporting a crime that is committed by a student to appropriate authorities; or (2) to prevent Federal, State, and tribal law enforcement and judicial authorities from exercising their responsibilities with regard to the application of Federal, tribal, and State law to crimes committed by a student. (i) Supplement, not supplant Any services provided through programs carried out under this section shall supplement, and not supplant, existing mental health services, including any special education and related services provided under the Individuals with Disabilities Education Act (20 U.S.C. 1400 et seq.). (j) Consultation with indian Tribes In carrying out subsection (a), the Secretary shall, in a timely manner, meaningfully consult, engage, and cooperate with Indian Tribes and their representatives to ensure notice of eligibility. (k) Definitions In this section: (1) Elementary or secondary school The term elementary or secondary school means a public elementary and secondary school as such term is defined in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (2) Evidence-based The term evidence-based has the meaning given such term in section 8101(21)(A)(i) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801(21)(A)(i)). (3) Native Hawaiian educational organization The term Native Hawaiian educational organization has the meaning given such term in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517). (4) Pipeline services The term pipeline services has the meaning given such term in section 4622 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517). (5) School leader The term school leader has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (6) Secretary The term Secretary means the Secretary of Education. (7) Specialized instructional support personnel The term specialized instructional support personnel has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). (l) Authorization of appropriations There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2019 through 2023. 1515. National Child Traumatic Stress Initiative Section 582(j) of the Public Health Service Act (42 U.S.C. 290hh–1(j)) (relating to grants to address the problems of persons who experience violence-related stress) is amended by striking $46,887,000 for each of fiscal years 2018 through 2022 and inserting $53,887,000 for each of fiscal years 2019 through 2023. 1516. National milestones to measure success in curtailing the opioid crisis (a) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall develop or identify existing national indicators (referred to in this section as the national milestones) to measure success in curtailing the opioid crisis, with the goal of significantly reversing the incidence and prevalence of opioid misuse and abuse, and opioid-related morbidity and mortality in the United States within 5 years of such date of enactment. (b) National milestones to end the opioid crisis The national milestones under subsection (a) shall include the following: (1) Not fewer than 10 indicators or metrics to accurately and expediently measure progress in meeting the goal described in subsection (a), which shall, as appropriate, include, indicators or metrics related to— (A) the number of fatal and non-fatal opioid overdoses; (B) the number of emergency room visits related to opioid misuse and abuse; (C) the number of individuals in sustained recovery from opioid use disorder; (D) the number of infections associated with illicit drug use, such as HIV, viral hepatitis, and infective endocarditis, and available capacity for treating such infections; (E) the number of providers prescribing medication assisted treatment for opioid use disorders, including in primary care settings, community health centers, jails, and prisons; (F) the number of individuals receiving treatment for opioid use disorder; and (G) additional indicators or metrics, as appropriate, such as metrics pertaining to specific populations, including women and children, American Indians and Alaskan Natives, individuals living in rural and non-urban areas, and justice-involved populations, that would further clarify the progress made in addressing the opioid misuse and abuse crisis. (2) A reasonable goal, such as a percentage decrease or other specified metric, that signifies progress in meeting the goal described in subsection (a), and annual targets to help achieve that goal. (c) Consideration of other substance use disorders In developing the national milestones under subsection (b), the Secretary shall, as appropriate, consider other substance use disorders in addition to opioid use disorder. (d) Extension of period If the Secretary determines that the goal described in subsection (a) will not be achieved with respect to any indicator or metric established under subsection (b)(2) within 5 years of the date of enactment of this Act, the Secretary may extend the timeline for meeting such goal with respect to that indicator or metric. The Secretary shall include with any such extension a rationale for why additional time is needed and information on whether significant changes are needed in order to achieve such goal with respect to the indicator or metric. (e) Annual status update Not later than one year after the enactment of this Act, the Secretary shall make available on the internet website of the Department of Health and Human Services, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an update on the progress, including expected progress in the subsequent year, in achieving the goals detailed in the national milestones. Each such update shall include the progress made in the first year or since the previous report, as applicable, in meeting each indicator or metric in the national milestones. II Finance 2001. Short title This title may be cited as the Helping to End Addiction and Lessen Substance Use Disorders Act of 2018 or the HEAL Act of 2018. A Medicare 2101. Medicare opioid safety education (a) In general Section 1804 of the Social Security Act (42 U.S.C. 1395b–2) is amended by adding at the end the following new subsection: (d) The notice provided under subsection (a) shall include— (1) references to educational resources regarding opioid use and pain management; (2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and (3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management. . (b) Effective date The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019. 2102. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders (a) In general Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended— (1) in paragraph (2)(B)— (A) in clause (i), in the matter preceding subclause (I), by striking clause (ii) and inserting clause (ii) and paragraph (6)(C); and (B) in clause (ii), in the heading, by striking for home dialysis therapy; (2) in paragraph (4)(C)— (A) in clause (i), by striking paragraph (6) and inserting paragraphs (5), (6), and (7); and (B) in clause (ii)(X), by inserting or telehealth services described in paragraph (7) before the period at the end; and (3) by adding at the end the following new paragraph: (7) Treatment of substance use disorder services furnished through telehealth The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after January 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph). . (b) Implementation The Secretary of Health and Human Services (in this section referred to as the Secretary) may implement the amendments made by this section by interim final rule. (c) Report Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) on— (1) the utilization of health care items and services under title XVIII of such Act (42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and (2) health outcomes related to substance use disorders, such as opioid overdose deaths. 2103. Comprehensive screenings for seniors (a) Initial preventive physical examination Section 1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is amended— (1) in paragraph (1)— (A) by striking paragraph (2) and and inserting paragraph (2),; and (B) by inserting and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), after ‘‘upon the agreement with the individual,”; and (2) in paragraph (2)— (A) by redesignating subparagraph (N) as subparagraph (O); and (B) by inserting after subparagraph (M) the following new subparagraph: (N) Screening for potential substance use disorders. ; and (3) by adding at the end the following new paragraph: (4) For purposes of paragraph (1), the term a review of any current opioid prescriptions means, with respect to an individual determined to have a current prescription for opioids— (A) a review of the potential risk factors to the individual for opioid use disorder; (B) an evaluation of the individual's severity of pain and current treatment plan; (C) the provision of information on non-opioid treatment options; and (D) a referral to a pain management specialist, as appropriate. . (b) Annual wellness visit Section 1861(hhh)(2) of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended— (1) by redesignating subparagraph (G) as subparagraph (I); and (2) by inserting after subparagraph (F) the following new subparagraphs: (G) Screening for potential substance use disorders and referral for treatment as appropriate. (H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)). . (c) Effective date The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2019. 2104. Every prescription conveyed securely (a) In general Section 1860D–4(e) of the Social Security Act (42 U.S.C. 1395w–104(e)) is amended by adding at the end the following: (7) Requirement of e-prescribing for controlled substances (A) In general Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2). (B) Exception for certain circumstances The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of— (i) a prescription issued when the practitioner and dispensing pharmacy are the same entity; (ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; (iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner; (iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved; (v) a prescription issued by a practitioner prescribing a drug under a research protocol; (vi) a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing such as, a drug with risk evaluation and mitigation strategies that include elements to assure safe use; (vii) a prescription issued by a practitioner— (I) for an individual who receives hospice care under this title; and (II) that is not covered under the hospice benefit under this title; and (viii) a prescription issued by a practitioner for an individual who is— (I) a resident of a nursing facility (as defined in section 1919(a)); and (II) dually eligible for benefits under this title and title XIX. (C) Dispensing (i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A). (ii) Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral or fax prescriptions that are consistent with laws and regulations. (iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph. (D) Enforcement The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A). . (b) Effective date The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021. 2105. Standardizing electronic prior authorization for safe prescribing Section 1860D–4(e)(2) of the Social Security Act (42 U.S.C. 1395w–104(e)(2)) is amended by adding at the end the following new subparagraph: (E) Electronic prior authorization (i) In general Not later than January 1, 2021, the program shall provide for the secure electronic transmittal of— (I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and (II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional. (ii) Electronic transmission (I) Exclusions For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i). (II) Standards In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors. (III) Application Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual. . 2106. Strengthening partnerships to prevent opioid abuse (a) In general Section 1859 of the Social Security Act (42 U.S.C. 1395w–28) is amended by adding at the end the following new subsection: (i) Program integrity transparency measures (1) Program integrity portal (A) In general Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure Internet website portal that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or any successor entity to a Medicare drug integrity contractor), in accordance with subsection (j)(3) of such section, for the purpose of enabling through such portal— (i) the referral by such plans of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and (ii) data sharing among such MA plans, prescription drug plans, and the Secretary. (B) Required uses of portal The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure Internet website portal established under subparagraph (A): (i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period. (ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise. (iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation. (iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal with respect to suspicious activities of a provider of services (including a prescriber) or supplier, if such provider (or prescriber) or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken. (C) Rulemaking For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes suspicious activities related to fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.7.1. (2) Quarterly reports Beginning not later than 2 years after the date of the enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall— (A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and (B) be anonymized information submitted by plans without identifying the source of such information. (3) Clarification Nothing in this subsection shall preclude or otherwise affect referrals to the Inspector General of the Department of Health and Human Services or other law enforcement entities. . (b) Contract requirement to communicate plan corrective actions against opioids over-prescribers Section 1857(e)(4)(C) of the Social Security Act (42 U.S.C. 1395w–27(e)(4)(C)) is amended by adding at the end the following new paragraph: (5) Communicating plan corrective actions against opioids over-prescribers (A) In general Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on credible evidence of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud and other actions taken by such plans related to inappropriate prescribing of opioids. (B) Process Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A). (C) Regulations For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking— (i) specify a definition for the term inappropriate prescribing of opioids and a method for determining if a provider of services prescribes such a high volume; and (ii) establish the process described in subparagraph (B) and the types of information that may be submitted through such process. . (c) Reference under part D to program integrity transparency measures Section 1860D–4 of the Social Security Act (42 U.S.C. 1395w–104) is amended by adding at the end the following new subsection: (m) Program integrity transparency measures For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i). . 2107. Commit to opioid medical prescriber accountability and safety for seniors Section 1860D–4(c)(4) of the Social Security Act (42 U.S.C. 1395w–104(c)(4)) is amended by adding at the end the following new subparagraph: (D) Notification and additional requirements with respect to statistical outlier prescribers of opioids (i) Notification Not later than January 1, 2021, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be a statistical outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified that includes resources on proper prescribing methods and other information as specified in accordance with clause (iii). (ii) Identification of statistical outlier prescribers of opioids (I) In general The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the thresholds established under subclause (II), identify prescribers that are statistical outlier opioids prescribers for a period of time specified by the Secretary. (II) Establishment of thresholds For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish thresholds, based on prescriber specialty and, as determined appropriate by the Secretary, geographic area, for identifying whether a prescriber in a specialty and geographic area is a statistical outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area. (III) Exclusions The following shall not be included in the analysis for identifying statistical outlier prescribers of opioids under this clause: (aa) Claims for covered part D drugs for part D eligible individuals who are receiving hospice care under this title. (bb) Claims for covered part D drugs for part D eligible individuals who are receiving oncology services under this title. (cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Inspector General of the Department of Health and Human Services. (iii) Contents of notification The Secretary shall include the following information in the notifications provided under clause (i): (I) Information on how such prescriber compares to other prescribers within the same specialty and, if determined appropriate by the Secretary, geographic area. (II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by physician organizations. (III) Other information determined appropriate by the Secretary. (iv) Modifications and expansions (I) Frequency Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input and changes in opioid prescribing utilization and trends. (II) Expansion to other prescriptions The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary. (v) Additional requirements for persistent statistical outlier prescribers In the case of a prescriber who the Secretary determines is persistently identified under clause (ii) as a statistical outlier prescriber of opioids, the following shall apply: (I) The Secretary shall provide an opportunity for such prescriber to receive technical assistance or educational resources on opioid prescribing guidelines (such as the guidelines described in clause (iii)(II)) from an entity that furnishes such assistance or resources, which may include a quality improvement organization under part B of title XI, as available and appropriate. (II) Such prescriber may be required to enroll in the program under this title under section 1866(j) if such prescriber is not otherwise required to enroll. The Secretary shall determine the length of the period for which such prescriber is required to maintain such enrollment. (III) Not less frequently than annually (and in a form and manner determined appropriate by the Secretary), the Secretary shall communicate information on such prescribers to sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA–PD plan. (vi) Public availability of information The Secretary shall make aggregate information under this subparagraph available on the Internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the Secretary and shall not identify any specific prescriber. In carrying out this clause, the Secretary shall consult with interested stakeholders. (vii) Opioids defined For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary. (viii) Other activities Nothing in this subparagraph shall preclude the Secretary from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, including activities that were being conducted as of the date of the enactment of this subparagraph. . 2108. Fighting the opioid epidemic with sunshine (a) Inclusion of information regarding payments to advance practice nurses (1) In general Section 1128G(e)(6) of the Social Security Act (42 U.S.C. 1320a–7h(e)(6)) is amended— (A) in subparagraph (A), by adding at the end the following new clauses: (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)). (iv) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)). (v) A certified nurse-midwife (as defined in section 1861(gg)(2)). ; and (B) in subparagraph (B), by inserting , physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife after physician. (2) Effective date The amendments made by this subsection shall apply with respect to information required to be submitted under section 1128G of the Social Security Act (42 U.S.C. 1320a–7h) on or after January 1, 2022. (b) Sunset of exclusion of National Provider Identifier of covered recipient in information made publicly available Section 1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a–7h(c)(1)(C)(viii))) is amended by striking does not contain and inserting in the case of information made available under this subparagraph prior to January 1, 2022, does not contain. (c) Administration Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section. 2109. Demonstration testing coverage of certain services furnished by opioid treatment programs Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E the following: 1866F. Demonstration testing coverage of certain services furnished by opioid treatment programs (a) Establishment (1) In general The Secretary shall conduct a demonstration (in this section referred to as the demonstration) to test coverage of and payment for opioid use disorder treatment services (as defined in paragraph (2)(B)) furnished by opioid treatment programs (as defined in paragraph (2)(A)) to individuals under part B using a bundled payment as described in paragraph (3). (2) Definitions In this section: (A) Opioid treatment program The term opioid treatment program means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that— (i) is selected for participation in the demonstration; (ii) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program; (iii) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; (iv) submits to the Secretary data and information needed to monitor the quality of services furnished and conduct the evaluation described in subsection (c); and (v) meets such additional requirements as the Secretary may find necessary. (B) Opioid use disorder treatment services The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including— (i) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder; (ii) dispensing and administration of such medications, if applicable; (iii) substance use counseling by a professional to the extent authorized under State law to furnish such services; (iv) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law); (v) toxicology testing; and (vi) other items and services that the Secretary determines are appropriate (but in no case to include meals or transportation). (3) Bundled payment under part B (A) In general The Secretary shall pay, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, to an opioid treatment program participating in the demonstration a bundled payment as determined by the Secretary for opioid use disorder treatment services that are furnished by such treatment program to an individual under part B during an episode of care (as defined by the Secretary). (B) Considerations The Secretary may implement this paragraph through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services furnished, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determines appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code. (b) Implementation (1) Duration The demonstration shall be conducted for a period of 5 years, beginning not later than January 1, 2021. (2) Scope In carrying out the demonstration, the Secretary shall limit the number of beneficiaries that may participate at any one time in the demonstration to 2,000. (3) Waiver The Secretary may waive such provisions of this title and title XI as the Secretary determines necessary in order to implement the demonstration. (4) Administration Chapter 35 of title 44, United States Code, shall not apply to this section. (c) Evaluation and report (1) Evaluation The Secretary shall conduct an evaluation of the demonstration. Such evaluation shall include analyses of— (A) the impact of the demonstration on— (i) utilization of health care items and services related to opioid use disorder, including hospitalizations and emergency department visits; (ii) beneficiary health outcomes related to opioid use disorder, including opioid overdose deaths; and (iii) overall expenditures under this title; and (B) the performance of opioid treatment programs participating in the demonstration with respect to applicable quality and cost metrics, including whether any additional quality measures related to opioid use disorder treatment are needed with respect to such programs under this title. (2) Report Not later than 2 years after the completion of the demonstration, the Secretary shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Secretary determines appropriate. (d) Funding For purposes of administering and carrying out the demonstration, in addition to funds otherwise appropriated, there shall be transferred to the Secretary for the Center for Medicare & Medicaid Services Program Management Account from the Federal Supplementary Medical Insurance Trust Fund under section 1841 $5,000,000, to remain available until expended. . 2110. Encouraging appropriate prescribing under Medicare for victims of opioid overdose Section 1860D–4(c)(5)(C) of the Social Security Act (42 U.S.C. 1395w–104(c)(5)(C)) is amended— (1) in clause (i), in the matter preceding subclause (I), by striking For purposes and inserting Except as provided in clause (v), for purposes; and (2) by adding at the end the following new clause: (v) Treatment of enrollees with a history of opioid-related overdose (I) In general For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph. (II) Identification and notice For purposes of this clause, the Secretary shall— (aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and (bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification. . 2111. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries (a) In general Section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended— (1) in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking and the option of an automatic escalation to external review and inserting , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution; and (2) in subparagraph (E), by striking and the option and all that follows and inserting the following: and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution.. (b) Effective date The amendments made by subsection (a) shall apply beginning not later January 1, 2021. 2112. Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the following new clause: (xxv) Providing incentive payments to behavioral health providers for the adoption and use of certified electronic health record technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information. Behavioral health providers may include— (I) psychiatric hospitals (as defined in section 1861(f)); (II) community mental health centers (as defined in section 1861(ff)(3)(B)); (III) clinical psychologists (as defined in section 1861(ii)); (IV) clinical social workers (as defined in section 1861(hh)(1)); and (V) hospitals, treatment facilities, and mental health or substance use disorder providers that participate in a State plan under title XIX or a waiver of such plan. . 2113. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking fiscal year 2021, $0 and inserting fiscal year 2024, $65,000,000. B Medicaid 2201. Caring recovery for infants and babies (a) State plan amendment Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended— (1) in paragraph (82), by striking and after the semicolon; (2) in paragraph (83), by striking the period at the end and inserting ; and; and (3) by inserting after paragraph (83), the following new paragraph: (84) provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (nn)) to infants with neonatal abstinence syndrome. . (b) Residential pediatric recovery center defined Section 1902 of such Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection: (nn) Residential pediatric recovery center defined (1) In general For purposes of section 1902(a)(84), the term residential pediatric recovery center means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors. (2) Counseling and services A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following: (A) Counseling or referrals for services. (B) Activities to encourage caregiver-infant bonding. (C) Training on caring for such infants. . (c) Effective date The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date. 2202. Peer support enhancement and evaluation review (a) In general Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the provision of peer support services under the Medicaid program. (b) Content of report (1) In general The report required under subsection (a) shall include the following information: (A) Information on State coverage of peer support services under Medicaid, including— (i) the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers; (ii) the populations to which States have provided such coverage; (iii) the payment models, including any alternative payment models, used by States to pay providers of such services; and (iv) where available, information on Federal and State spending under Medicaid for peer support services. (B) Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to— (i) improving access to behavioral health services; (ii) improving early detection, and preventing worsening, of behavioral health disorders; (iii) reducing chronic and comorbid conditions; and (iv) reducing overall health costs. (2) Recommendations The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate. 2203. Medicaid substance use disorder treatment via telehealth (a) Definitions In this section: (1) Comptroller General The term Comptroller General means the Comptroller General of the United States. (2) School-based health center The term school-based health center has the meaning given that term in section 2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Teleheath services The term telehealth services includes remote patient monitoring and other key modalities such as live video or synchronous telehealth, store-and-forward or asynchronous telehealth, mobile health, telephonic consultation, and electronic consult including provider-to-provider e-consults. (5) Underserved area The term underserved area means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A))) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act (42 U.S.C. 254b(b)(3)(A))). (b) Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using telehealth services, including in school-based health centers Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following: (1) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, and medication management, using telehealth services. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high risk individuals, including at least the following groups: (A) American Indians and Alaska Natives. (B) Adults under the age of 40. (C) Individuals with a history of nonfatal overdose. (2) State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment (DSRIP) programs. (3) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using telehealth services. (c) GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid (1) Study The Comptroller General shall evaluate children's access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using telehealth services, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders. (2) Report Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. (d) Report on reducing barriers to using telehealth services and remote patient monitoring for pediatric populations under Medicaid (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representative identifying best practices and potential solutions for reducing barriers to using telehealth services to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include— (A) analyses of the best practices, barriers, and potential solutions for using telehealth services to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and (B) identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using telehealth services and using services delivered in person, such as, and to the extent feasible, with respect to— (i) utilization rates; (ii) costs; (iii) avoidable inpatient admissions and readmissions; (iv) quality of care; and (v) patient, family, and provider satisfaction. (2) Publication The Secretary shall publish the report required under paragraph (1) on a public Internet website of the Department of Health and Human Services. 2204. Enhancing patient access to non-opioid treatment options Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based non-opioid pharmacological therapies and non-pharmacological therapies. 2205. Assessing barriers to opioid use disorder treatment (a) Study (1) In general The Comptroller General of the United States (in this section referred to as the Comptroller General) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the buy-and-bill model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations: (A) The purchasing, storage, and administration of substance use disorder treatment medications by providers. (B) The dispensing of substance use disorder treatment medications by pharmacists. (C) The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers. (2) Requirements For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on— (A) Medicaid beneficiaries’ access to substance use disorder treatment medications; (B) the differential cost to the program between each distribution model for medication assisted treatment; and (C) provider willingness to provide or prescribe substance use disorder treatment medications. (b) Report Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. 2206. Help for moms and babies (a) Medicaid state plan Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended by adding at the end the following new sentence: In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of medical assistance set forth in the subdivision (B) following paragraph (29) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution.. (b) Effective date (1) In general Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act. (2) Rule for changes requiring state legislation In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. 2207. Securing flexibility to treat substance use disorders Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is amended by adding at the end the following new paragraph: (7) Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation). . 2208. MACPAC study and report on MAT utilization controls under State Medicaid programs (a) Study The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall— (1) include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment; (2) determine whether managed care utilization control policies and procedures for medication assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and (3) identify policies that— (A) limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and (B) apply without evaluating individual instances of fraud, waste, or abuse. (b) Report Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a). 2209. Opioid addiction treatment programs enhancement (a) T–MSIS substance use disorder data book (1) In general Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid. (2) Content of report The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa): (A) The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available. (B) A list of the substance use disorder treatment services by each major type of service, such as counseling, medication assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan. (C) The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home and community-based settings. (D) The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B). (E) The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through— (i) a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u–2(a)(1)(B))), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan; (ii) a fee-for-service payment model; or (iii) an alternative payment model, to the extent available. (F) The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home and community-based setting. (3) Annual updates The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024. (4) Use of T–MSIS data The report required under paragraph (1) and updates required under paragraph (3) shall— (A) use data and definitions from the Transformed Medicaid Statistical Information System (T–MSIS) data set that is no more than 12 months old on the date that the report or update is published; and (B) as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information. (b) Making T–MSIS data on substance use disorders available to researchers (1) In general The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System. (2) Required data The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings. (3) Initiation of data-sharing activities Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1). 2210. Better data sharing to combat the opioid crisis (a) In general Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by section 2207, is amended by adding at the end the following new paragraph: (8) (A) The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law. (B) Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). (C) Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with— (i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and (ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3). . (b) Security and privacy All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (42 U.S.C. 1396b(m)(8)) (as added by subsection (a)). (c) Effective date The amendment made by subsection (a) shall take effect on the date of enactment of this Act. 2211. Mandatory reporting with respect to adult behavioral health measures Section 1139B of the Social Security Act (42 U.S.C. 1320b–9b) is amended— (1) in subsection (b)— (A) in paragraph (3)— (i) by striking Not later than January 1, 2013 and inserting the following: (A) Voluntary reporting Not later than January 1, 2013 ; and (ii) by adding at the end the following: (B) Mandatory reporting with respect to behavioral health measures Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults. ; (B) in paragraph (5), by adding at the end the following new subparagraph: (C) Behavioral health measures Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures. ; and (2) in subsection (d)(1)(A)— (A) by striking the such plan and inserting such plan; and (B) by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)). 2212. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness. (b) Content of report The report required under subsection (a) shall describe the following: (1) Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are— (A) receiving treatment for substance use disorders in inpatient, residential, outpatient, or home and community-based settings; (B) transitioning between substance use disorder treatment settings; or (C) living in supportive housing or another model of affordable housing. (2) Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings. (3) Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), including— (A) challenges experienced by States in designing, securing, and implementing such waivers or plan amendments; (B) how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and (C) how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers. (4) Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program. (5) Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs. 2213. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid (a) In general The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders. (b) Report Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a). C Human Services 2301. Supporting family-focused residential treatment (a) Definitions In this section: (1) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (2) Medicaid program The term Medicaid program means the program established under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.). (3) Secretary The term Secretary means the Secretary of Health and Human Services. (4) Title IV–E program The term title IV–E program means the program for foster care, prevention, and permanency established under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.). (b) Guidance on family-focused residential treatment programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with divisions of the Department of Health and Human Services administering substance use disorder or child welfare programs, shall develop and issue guidance to States identifying opportunities to support family-focused residential treatment programs for the provision of substance use disorder treatment. Before issuing such guidance, the Secretary shall solicit input from representatives of States, health care providers with expertise in addiction medicine, obstetrics and gynecology, neonatology, child trauma, and child development, health plans, recipients of family-focused treatment services, and other relevant stakeholders. (2) Additional requirements The guidance required under paragraph (1) shall include descriptions of the following: (A) Existing opportunities and flexibilities under the Medicaid program, including under waivers authorized under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), for States to receive Federal Medicaid funding for the provision of substance use disorder treatment for pregnant and postpartum women and parents and guardians and, to the extent applicable, their children, in family-focused residential treatment programs. (B) How States can employ and coordinate funding provided under the Medicaid program, the title IV-E program, and other programs administered by the Secretary to support the provision of treatment and services provided by a family-focused residential treatment facility such as substance use disorder treatment and services, including medication-assisted treatment, family, group, and individual counseling, case management, parenting education and skills development, the provision, assessment, or coordination of care and services for children, including necessary assessments and appropriate interventions, non-emergency transportation for necessary care provided at or away from a program site, transitional services and supports for families leaving treatment, and other services. (C) How States can employ and coordinate funding provided under the Medicaid program and the title IV–E program (including as amended by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123, and particularly with respect to the authority under subsections (a)(2)(C) and (j) of section 472 and section 474(a)(1) of the Social Security Act (42 U.S.C. 672, 674(a)(1)) (as amended by section 50712 of Public Law 115–123) to provide foster care maintenance payments for a child placed with a parent who is receiving treatment in a licensed residential family-based treatment facility for a substance use disorder) to support placing children with their parents in family-focused residential treatment programs. 2302. Improving recovery and reunifying families (a) Family Recovery and Reunification Program Replication Project Section 435 of the Social Security Act (42 U.S.C. 629e) is amended by adding at the end the following: (e) Family Recovery and Reunification Program Replication Project (1) Purpose The purpose of this subsection is to provide resources to the Secretary to support the conduct and evaluation of a family recovery and reunification program replication project (referred to in this subsection as the project) and to determine the extent to which such programs may be appropriate for use at different intervention points (such as when a child is at risk of entering foster care or when a child is living with a guardian while a parent is in treatment). The family recovery and reunification program conducted under the project shall use a recovery coach model that is designed to help reunify families and protect children by working with parents or guardians with a substance use disorder who have temporarily lost custody of their children. (2) Program components The family recovery and reunification program conducted under the project shall adhere closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children and, consistent with such elements and protocol, shall provide such items and services as— (A) assessments to evaluate the needs of the parent or guardian; (B) assistance in receiving the appropriate benefits to aid the parent or guardian in recovery; (C) services to assist the parent or guardian in prioritizing issues identified in assessments, establishing goals for resolving such issues that are consistent with the goals of the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children, and making a coordinated plan for achieving such goals; (D) home visiting services coordinated with the child welfare agency and treatment provider involved with the parent or guardian or their children; (E) case management services to remove barriers for the parent or guardian to participate and continue in treatment, as well as to re-engage a parent or guardian who is not participating or progressing in treatment; (F) access to services needed to monitor the parent’s or guardian's compliance with program requirements; (G) frequent reporting between the treatment provider, child welfare agency, courts, and other agencies involved with the parent or guardian or their children to ensure appropriate information on the parent’s or guardian's status is available to inform decision-making; and (H) assessments and recommendations provided by a recovery coach to the child welfare caseworker responsible for documenting the parent’s or guardian's progress in treatment and recovery as well as the status of other areas identified in the treatment plan for the parent or guardian, including a recommendation regarding the expected safety of the child if the child is returned to the custody of the parent or guardian that can be used by the caseworker and a court to make permanency decisions regarding the child. (3) Responsibilities of the secretary (A) In general The Secretary shall, through a grant or contract with 1 or more entities, conduct and evaluate the family recovery and reunification program under the project. (B) Requirements In identifying 1 or more entities to conduct the evaluation of the family recovery and reunification program, the Secretary shall— (i) determine that the area or areas in which the program will be conducted have sufficient substance use disorder treatment providers and other resources (other than those provided with funds made available to carry out the project) to successfully conduct the program; (ii) determine that the area or areas in which the program will be conducted have enough potential program participants, and will serve a sufficient number of parents or guardians and their children, so as to allow for the formation of a control group, evaluation results to be adequately powered, and preliminary results of the evaluation to be available within 4 years of the program's implementation; (iii) provide the entity or entities with technical assistance for the program design, including by working with 1 or more entities that are or have been involved in recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children so as to make sure the program conducted under the project adheres closely to the elements and protocol determined to be most effective in such other recovery coaching programs; (iv) assist the entity or entities in securing adequate coaching, treatment, child welfare, court, and other resources needed to successfully conduct the family recovery and reunification program under the project; and (v) ensure the entity or entities will be able to monitor the impacts of the program in the area or areas in which it is conducted for at least 5 years after parents or guardians and their children are randomly assigned to participate in the program or to be part of the program's control group. (4) Evaluation requirements (A) In general The Secretary, in consultation with the entity or entities conducting the family recovery and reunification program under the project, shall conduct an evaluation to determine whether the program has been implemented effectively and resulted in improvements for children and families. The evaluation shall have 3 components: a pilot phase, an impact study, and an implementation study. (B) Pilot phase The pilot phase component of the evaluation shall consist of the Secretary providing technical assistance to the entity or entities conducting the family recovery and reunification program under the project to ensure— (i) the program's implementation adheres closely to the elements and protocol determined to be most effective in other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) random assignment of parents or guardians and their children to be participants in the program or to be part of the program's control group is being carried out. (C) Impact study The impact study component of the evaluation shall determine the impacts of the family recovery and reunification program conducted under the project on the parents and guardians and their children participating in the program. The impact study component shall— (i) be conducted using an experimental design that uses a random assignment research methodology; (ii) consistent with previous studies of other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children, measure outcomes for parents and guardians and their children over multiple time periods, including for a period of 5 years; and (iii) include measurements of family stability and parent, guardian, and child safety for program participants and the program control group that are consistent with measurements of such factors for participants and control groups from previous studies of other recovery coaching programs so as to allow results of the impact study to be compared with the results of such prior studies, including with respect to comparisons between program participants and the program control group regarding— (I) safe family reunification; (II) time to reunification; (III) permanency (such as through measures of reunification, adoption, or placement with guardians); (IV) safety (such as through measures of subsequent maltreatment); (V) parental or guardian treatment persistence and engagement; (VI) parental or guardian substance use; (VII) juvenile delinquency; (VIII) cost; and (IX) other measurements agreed upon by the Secretary and the entity or entities operating the family recovery and reunification program under the project. (D) Implementation study The implementation study component of the evaluation shall be conducted concurrently with the conduct of the impact study component and shall include, in addition to such other information as the Secretary may determine, descriptions and analyses of— (i) the adherence of the family recovery and reunification program conducted under the project to other recovery coaching programs that have been rigorously evaluated and shown to increase family reunification and protect children; and (ii) the difference in services received or proposed to be received by the program participants and the program control group. (E) Report The Secretary shall publish on an internet website maintained by the Secretary the following information: (i) A report on the pilot phase component of the evaluation. (ii) A report on the impact study component of the evaluation. (iii) A report on the implementation study component of the evaluation. (iv) A report that includes— (I) analyses of the extent to which the program has resulted in increased reunifications, increased permanency, case closures, net savings to the State or States involved (taking into account both costs borne by States and the Federal government), or other outcomes, or if the program did not produce such outcomes, an analysis of why the replication of the program did not yield such results; (II) if, based on such analyses, the Secretary determines the program should be replicated, a replication plan; and (III) such recommendations for legislation and administrative action as the Secretary determines appropriate. (5) Appropriation In addition to any amounts otherwise made available to carry out this subpart, out of any money in the Treasury of the United States not otherwise appropriated, there are appropriated $15,000,000 for fiscal year 2019 to carry out the project, which shall remain available through fiscal year 2026. . (b) Clarification of payer of last resort application to child welfare prevention and family services Section 471(e)(10) of the Social Security Act (42 U.S.C. 671(e)(10)), as added by section 50711(a)(2) of division E of Public Law 115–123, is amended— (1) in subparagraph (A), by inserting , nor shall the provision of such services or programs be construed to permit the State to reduce medical or other assistance available to a recipient of such services or programs after under this Act; and (2) by adding at the end the following: (C) Payer of last resort In carrying out its responsibilities to ensure access to services or programs under this subsection, the State agency shall not be considered to be a legally liable third party for purposes of satisfying a financial commitment for the cost of providing such services or programs with respect to any individual for whom such cost would have been paid for from another public or private source but for the enactment of this subsection (except that whenever considered necessary to prevent a delay in the receipt of appropriate early intervention services by a child or family in a timely fashion, funds provided under section 474(a)(6) may be used to pay the provider of services or programs pending reimbursement from the public or private source that has ultimate responsibility for the payment). . (c) Effective date The amendments made by subsection (b) shall take effect as if included in section 50711 of division E of Public Law 115–123. 2303. Building capacity for family-focused residential treatment (a) Definitions In this section: (1) Eligible entity The term eligible entity means a State, county, local, or tribal health or child welfare agency, a private nonprofit organization, a research organization, a treatment service provider, an institution of higher education (as defined under section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), or another entity specified by the Secretary. (2) Family-focused residential treatment program The term family-focused residential treatment program means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (3) Secretary The term Secretary means the Secretary of Health and Human Services. (b) Support for the development of evidence-based family-focused residential treatment programs (1) Authority to award grants The Secretary shall award grants to eligible entities for purposes of developing, enhancing, or evaluating family-focused residential treatment programs to increase the availability of such programs that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act (42 U.S.C. 671(e)(4)(C))) (as added by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123). (2) Evaluation requirement The Secretary shall require any evaluation of a family-focused residential treatment program by an eligible entity that uses funds awarded under this section for all or part of the costs of the evaluation be designed to assist in the determination of whether the program may qualify as a promising, supported, or well-supported practice in accordance with the requirements of such section 471(e)(4)(C). (c) Authorization of appropriations There is authorized to be appropriated to the Secretary to carry out this section, $20,000,000 for fiscal year 2019, which shall remain available through fiscal year 2023. D Synthetics Trafficking and Overdose Prevention 2401. Short title This subtitle may be cited as the Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018. 2402. Customs fees (a) In general Section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(b)(9)) is amended by adding at the end the following: (D) (i) With respect to the processing of items that are sent to the United States through the international postal network by Inbound Express Mail service or Inbound EMS (as that service is described in the mail classification schedule referred to in section 3631 of title 39, United States Code), the following payments are required: (I) $1 per Inbound EMS item. (II) If an Inbound EMS item is formally entered, the fee provided for under subsection (a)(9), if applicable. (ii) Notwithstanding section 451 of the Tariff Act of 1930 (19 U.S.C. 1451), the payments required by clause (i), as allocated pursuant to clause (iii)(I), shall be the only payments required for reimbursement of U.S. Customs and Border Protection for customs services provided in connection with the processing of an Inbound EMS item. (iii) (I) The payments required by clause (i)(I) shall be allocated as follows: (aa) 50 percent of the amount of the payments shall be paid on a quarterly basis by the United States Postal Service to the Commissioner of U.S. Customs and Border Protection in accordance with regulations prescribed by the Secretary of the Treasury to reimburse U.S. Customs and Border Protection for customs services provided in connection with the processing of Inbound EMS items. (bb) 50 percent of the amount of the payments shall be retained by the Postal Service to reimburse the Postal Service for services provided in connection with the customs processing of Inbound EMS items. (II) Payments received by U.S. Customs and Border Protection under subclause (I)(aa) shall, in accordance with section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be deposited in the Customs User Fee Account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities. Amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services. (III) Payments retained by the Postal Service under subclause (I)(bb) shall be used to directly reimburse the Postal Service for the costs incurred in providing services in connection with the customs processing of Inbound EMS items. (iv) Beginning in fiscal year 2021, the Secretary, in consultation with the Postmaster General, may adjust, not more frequently than once each fiscal year, the amount described in clause (i)(I) to an amount commensurate with the costs of services provided in connection with the customs processing of Inbound EMS items, consistent with the obligations of the United States under international agreements. . (b) Conforming amendments Section 13031(a) of the Consolidated Omnibus Budget Reconciliation Act of 1985 (19 U.S.C. 58c(a)) is amended— (1) in paragraph (6), by inserting (other than an item subject to a fee under subsection (b)(9)(D)) after customs officer; and (2) in paragraph (10)— (A) in subparagraph (C), in the matter preceding clause (i), by inserting (other than Inbound EMS items described in subsection (b)(9)(D)) after release; and (B) in the flush at the end, by inserting or of Inbound EMS items described in subsection (b)(9)(D), after (C),. (c) Effective date The amendments made by this section shall take effect on January 1, 2020. 2403. Mandatory advance electronic information for postal shipments (a) Mandatory advance electronic information (1) In general Section 343(a)(3)(K) of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended to read as follows: (K) (i) The Secretary shall prescribe regulations requiring the United States Postal Service to transmit the information described in paragraphs (1) and (2) to the Commissioner of U.S. Customs and Border Protection for international mail shipments by the Postal Service (including shipments to the Postal Service from foreign postal operators that are transported by private carrier) consistent with the requirements of this subparagraph. (ii) In prescribing regulations under clause (i), the Secretary shall impose requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo, taking into account the parameters set forth in subparagraphs (A) through (J). (iii) The regulations prescribed under clause (i) shall require the transmission of the information described in paragraphs (1) and (2) with respect to a shipment as soon as practicable in relation to the transportation of the shipment, consistent with subparagraph (H). (iv) Regulations prescribed under clause (i) shall allow for the requirements for the transmission to the Commissioner of information described in paragraphs (1) and (2) for mail shipments described in clause (i) to be implemented in phases, as appropriate, by— (I) setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the Commissioner; and (II) taking into consideration— (aa) the risk posed by such shipments; (bb) the volume of mail shipped to the United States by or through a particular country; and (cc) the capacities of foreign postal operators to provide that information to the Postal Service. (v) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2018, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for not less than 70 percent of the aggregate number of mail shipments, including 100 percent of mail shipments from the People’s Republic of China, described in clause (i). (II) If the requirements of subclause (I) are not met, the Comptroller General of the United States shall submit to the appropriate congressional committees, not later than June 30, 2019, a report— (aa) assessing the reasons for the failure to meet those requirements; and (bb) identifying recommendations to improve the collection by the Postal Service of the information described in paragraphs (1) and (2). (vi) (I) Notwithstanding clause (iv), the Postal Service shall, not later than December 31, 2020, arrange for the transmission to the Commissioner of the information described in paragraphs (1) and (2) for 100 percent of the aggregate number of mail shipments described in clause (i). (II) The Commissioner, in consultation with the Postmaster General, may determine to exclude a country from the requirement described in subclause (I) to transmit information for mail shipments described in clause (i) from the country if the Commissioner determines that the country— (aa) does not have the capacity to collect and transmit such information; (bb) represents a low risk for mail shipments that violate relevant United States laws and regulations; and (cc) accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant United States laws and regulations through an alternate means. (III) The Commissioner shall, at a minimum on an annual basis, re-evaluate any determination made under subclause (II) to exclude a country from the requirement described in subclause (I). If, at any time, the Commissioner determines that a country no longer meets the requirements under subclause (II), the Commissioner may not further exclude the country from the requirement described in subclause (I). (IV) The Commissioner shall, on an annual basis, submit to the appropriate congressional committees— (aa) a list of countries with respect to which the Commissioner has made a determination under subclause (II) to exclude the countries from the requirement described in subclause (I); and (bb) information used to support such determination with respect to such countries. (vii) (I) The Postmaster General shall, in consultation with the Commissioner, refuse any shipments received after December 31, 2020, for which the information described in paragraphs (1) and (2) is not transmitted as required under this subparagraph, except as provided in subclause (II). (II) If remedial action is warranted in lieu of refusal of shipments pursuant to subclause (I), the Postmaster General and the Commissioner shall take remedial action with respect to the shipments, including destruction, seizure, controlled delivery or other law enforcement initiatives, or correction of the failure to provide the information described in paragraphs (1) and (2) with respect to the shipment. (viii) Nothing in this subparagraph shall be construed to limit the authority of the Secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties. (ix) In this subparagraph, the term appropriate congressional committees means— (I) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (II) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. . (2) Joint strategic plan on mandatory advance information Not later than 60 days after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving— (A) the transmission of information as required by section 343(a)(3)(K) of the Trade Act of 2002, as amended by paragraph (1); and (B) the presentation by the Postal Service to U.S. Customs and Border Protection of all mail targeted by U.S. Customs and Border Protection for inspection. (b) Capacity building (1) In general Section 343(a) of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended by adding at the end the following: (5) Capacity building (A) In general The Secretary, with the concurrence of the Secretary of State, and in coordination with the Postmaster General and the heads of other Federal agencies, as appropriate, may provide technical assistance, equipment, technology, and training to enhance the capacity of foreign postal operators— (i) to gather and provide the information required by paragraph (3)(K); and (ii) to otherwise gather and provide postal shipment information related to— (I) terrorism; (II) items the importation or introduction of which into the United States is prohibited or restricted, including controlled substances; and (III) such other concerns as the Secretary determines appropriate. (B) Provision of equipment and technology With respect to the provision of equipment and technology under subparagraph (A), the Secretary may lease, loan, provide, or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the Secretary may prescribe, including nonreimbursable loans or the transfer of ownership of equipment and technology. . (2) Joint strategic plan on capacity building Not later than one year after the date of the enactment of this Act, the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly develop and submit to the appropriate congressional committees a joint strategic plan— (A) detailing the extent to which U.S. Customs and Border Protection and the United States Postal Service are engaged in capacity building efforts under section 343(a)(5) of the Trade Act of 2002, as added by paragraph (1); (B) describing plans for future capacity building efforts; and (C) assessing how capacity building has increased the ability of U.S. Customs and Border Protection and the Postal Service to advance the goals of this subtitle and the amendments made by this subtitle. (c) Report and consultations by Secretary of Homeland Security and Postmaster General (1) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 3 years after the Postmaster General has met the requirement under clause (vi) of subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), the Secretary of Homeland Security and the Postmaster General shall, in consultation with the Secretary of State, jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following: (A) An assessment of the status of the regulations required to be promulgated under that subparagraph. (B) An update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph. (C) A summary of deliberations between the United States Postal Service and foreign postal operators with respect to issues relating to the transmission of that information. (D) A summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph. (E) An assessment of the quality of that information being received by foreign postal operators, as determined by the Secretary of Homeland Security, and actions taken to improve the quality of that information. (F) A summary of policies established by the Universal Postal Union that may affect the ability of the Postmaster General to obtain the transmission of that information. (G) A summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology. (H) Such other information as the Secretary of Homeland Security and the Postmaster General consider appropriate with respect to obtaining the transmission of information required by that subparagraph. (2) Consultations Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the Postmaster General has met the requirement under clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002, as amended by subsection (a)(1), to arrange for the transmission of information with respect to 100 percent of the aggregate number of mail shipments described in clause (i) of that section, the Secretary of Homeland Security and the Postmaster General shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments. (d) Government Accountability Office report Not later than June 30, 2019, the Comptroller General of the United States shall submit to the appropriate congressional committees a report— (1) assessing the progress of the United States Postal Service in achieving the transmission of the information required by subparagraph (K) of section 343(a)(3) of the Trade Act of 2002, as amended by subsection (a)(1), for the percentage of shipments required by that subparagraph; (2) assessing the quality of the information received from foreign postal operators for targeting purposes; (3) assessing the specific percentage of targeted mail presented by the Postal Service to U.S. Customs and Border Protection for inspection; (4) describing the costs of collecting the information required by such subparagraph (K) from foreign postal operators and the costs of implementing the use of that information; (5) assessing the benefits of receiving that information with respect to international mail shipments; (6) assessing the feasibility of assessing a customs fee under section 13031(b)(9) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 2402, on international mail shipments other than Inbound Express Mail service in a manner consistent with the obligations of the United States under international agreements; and (7) identifying recommendations, including recommendations for legislation, to improve the compliance of the Postal Service with such subparagraph (K), including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by— (A) requiring the Postal Service to serve as the consignee for international mail shipments containing goods; or (B) designating a customs broker to act as an importer of record for international mail shipments containing goods. (e) Technical correction Section 343 of the Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 note) is amended in the section heading by striking advanced and inserting advance. (f) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 2404. International postal agreements (a) Existing agreements (1) In general In the event that any provision of this subtitle, or any amendment made by this subtitle, is determined to be in violation of obligations of the United States under any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, the Secretary of State should negotiate to amend the relevant provisions of the agreement so that the United States is no longer in violation of the agreement. (2) Rule of construction Nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle. (b) Future agreements (1) Consultations Before entering into, on or after the date of the enactment of this Act, any postal treaty, convention, or other international agreement related to international postal services, or any amendment to such an agreement, that is related to the ability of the United States to secure the provision of advance electronic information by foreign postal operators, the Secretary of State should consult with the appropriate congressional committees (as defined in section 2403(f)). (2) Expedited negotiation of new agreement To the extent that any new postal treaty, convention, or other international agreement related to international postal services would improve the ability of the United States to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section 343(a)(3)(K) of the Trade Act of 2002, as amended by section 2403(a)(1), the Secretary of State should expeditiously conclude such an agreement. 2405. Cost recoupment (a) In general The United States Postal Service shall, to the extent practicable and otherwise recoverable by law, ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators. (b) Costs not considered revenue The recovery of costs under subsection (a) shall not be deemed revenue for purposes of subchapter I and II of chapter 36 of title 39, United States Code, or regulations prescribed under that chapter. 2406. Development of technology to detect illicit narcotics (a) In general The Postmaster General and the Commissioner of U.S. Customs and Border Protection, in coordination with the heads of other agencies as appropriate, shall collaborate to identify and develop technology for the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States by mail. (b) Outreach to private sector The Postmaster General and the Commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl, other synthetic opioids, and other narcotics and psychoactive substances entering the United States. 2407. Civil penalties for postal shipments Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is amended by adding at the end the following new subsection: (e) Civil penalties for postal shipments (1) Civil penalty A civil penalty shall be imposed against the United States Postal Service if the Postal Service accepts a shipment in violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (2) Modification of civil penalty (A) In general U.S. Customs and Border Protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph (1) if U.S. Customs and Border Protection determines that the United States Postal Service— (i) has a low error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002; (ii) is cooperating with U.S. Customs and Border Protection with respect to the violation of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or (iii) has taken remedial action to prevent future violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002. (B) Written notification U.S. Customs and Border Protection shall issue a written notification to the Postal Service with respect to each exercise of the authority of subparagraph (A) to reduce or dismiss a civil penalty imposed pursuant to paragraph (1). (3) Ongoing lack of compliance If U.S. Customs and Border Protection determines that the United States Postal Service— (A) has repeatedly committed violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, (B) has failed to cooperate with U.S. Customs and Border Protection with respect to violations of section 343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and (C) has an increasing error rate in compliance with section 343(a)(3)(K) of the Trade Act of 2002, civil penalties may be imposed against the United States Postal Service until corrective action, satisfactory to U.S. Customs and Border Protection, is taken. . 2408. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest (a) In general The Commissioner of U.S. Customs and Border Protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection (b) with respect to each violation of section 436 of the Tariff Act of 1930 (19 U.S.C. 1436), as amended by section 7, and section 584 of such Act (19 U.S.C. 1584) that occurred during the previous year. (b) Information described The information described in this subsection is the following: (1) The name and address of the violator. (2) The specific violation that was committed. (3) The location or port of entry through which the items were transported. (4) An inventory of the items seized, including a description of the items and the quantity seized. (5) The location from which the items originated. (6) The entity responsible for the apprehension or seizure, organized by location or port of entry. (7) The amount of penalties assessed by U.S. Customs and Border Protection, organized by name of the violator and location or port of entry. (8) The amount of penalties that U.S. Customs and Border Protection could have levied, organized by name of the violator and location or port of entry. (9) The rationale for negotiating lower penalties, organized by name of the violator and location or port of entry. (c) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Finance and the Committee on Homeland Security and Governmental Affairs of the Senate; and (2) the Committee on Ways and Means, the Committee on Oversight and Government Reform, and the Committee on Homeland Security of the House of Representatives. 2409. Effective date; regulations (a) Effective date This subtitle and the amendments made by this subtitle (other than the amendments made by section 2402) shall take effect on the date of the enactment of this Act. (b) Regulations Not later than one year after the date of the enactment of this Act, such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed. III Judiciary A Access to Increased Drug Disposal 3101. Short title This subtitle may be cited as the Access to Increased Drug Disposal Act of 2018. 3102. Definitions In this subtitle— (1) the term Attorney General means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs; (2) the term authorized collector means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation); (3) the term covered grant means a grant awarded under section 3003; and (4) the term eligible collector means a person who is eligible to be an authorized collector. 3103. Authority to make grants The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors. 3104. Application A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum— (1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant; (2) details a plan to increase participation rates of eligible collectors as authorized collectors; and (3) describes how the State will select eligible collectors to be served under the grant. 3105. Use of grant funds A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors. 3106. Eligibility for grant The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General. 3107. Duration of grants The Attorney General shall determine the period of years for which a covered grant is made to a State. 3108. Accountability and oversight A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that— (1) lists the ultimate recipients of the grant amounts; (2) describes the activities undertaken by the State using the grant amounts; and (3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors. 3109. Duration of program The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act. 3110. Authorization of appropriations There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this subtitle. B Using Data To Prevent Opioid Diversion 3201. Short title This subtitle may be cited as the Using Data to Prevent Opioid Diversion Act of 2018. 3202. Purpose (a) In general The purpose of this subtitle is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates. (b) Rule of construction Nothing in this subtitle should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to— (1) identify, stop, and report suspicious orders; or (2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation. 3203. Amendments (a) Records and reports of registrants Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended— (1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively; (2) by inserting after subsection (e) the following: (f) (1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances: (A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant. (B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A). (2) The information required to be made available under paragraph (1) shall be made available not later than the 15th day of the first month following the quarter to which the information relates. (3) (A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection. (B) In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant. ; and (3) by inserting after subsection (i), as so redesignated, the following: (j) All of the reports required under this section shall be provided in an electronic format. . (b) Cooperative arrangements Section 503 of the Controlled Substances Act (21 U.S.C. 873) is amended— (1) by striking subsection (c) and inserting the following: (c) (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse. (2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection. . (c) Civil and criminal penalties Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended— (1) in subsection (a)— (A) in paragraph (15), by striking or at the end; (B) in paragraph (16), by striking the period at the end and inserting ; or; and (C) by inserting after paragraph (16) the following: (17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f). ; and (2) in subsection (c)— (A) in paragraph (1), by striking subparagraph (B) and inserting the following: (B) (i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the penalty shall not exceed $10,000. (ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000. ; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting or (D) after subparagraph (B); and (ii) by adding at the end the following: (D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000. . 3204. Report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor. C Substance Abuse Prevention 3301. Short title This subtitle may be cited as the Substance Abuse Prevention Act of 2018. 3302. Reauthorization of the Office of National Drug Control Policy (a) Office of National Drug Control Policy Reauthorization Act of 1998 (1) In general The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.), as in effect on September 29, 2003, and as amended by the laws described in paragraph (2), is revived and restored. (2) Laws described The laws described in this paragraph are: (A) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469; 120 Stat. 3502). (B) The Presidential Appointment Efficiency and Streamlining Act of 2011 (Public Law 112–166; 126 Stat. 1283). (b) Reauthorization Section 715(a) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1712(a)) is amended by striking 2010 and inserting 2022. 3303. Reauthorization of the Drug-Free Communities Program Section 1024 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1524(a)) is amended by striking subsections (a) and (b) and inserting the following: (a) In general There is authorized to be appropriated to the Office of National Drug Control Policy to carry out this chapter $99,000,000 for each of fiscal years 2018 through 2022. (b) Administrative costs Not more than 8 percent of the funds appropriated to carry out this chapter may be used by the Office of National Drug Control Policy to pay administrative costs associated with the responsibilities of the Office under this chapter. . 3304. Reauthorization of the National Community Anti-Drug Coalition Institute Section 4(c)(4) of Public Law 107–82 (21 U.S.C. 1521 note) is amended by striking 2008 through 2012 and inserting 2018 through 2022. 3305. Reauthorization of the High-Intensity Drug Trafficking Area Program Section 707(p) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706(p)) is amended— (1) in paragraph (4), by striking and at the end; (2) in paragraph (5), by striking the period at the end and inserting ; and; and (3) by adding at the end the following: (6) $280,000,000 for each of fiscal years 2018 through 2022. . 3306. Reauthorization of drug court program Section 1001(a)(25)(A) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10261(a)(25)(A)) is amended by striking Except as provided and all that follows and inserting the following: Except as provided in subparagraph (C), there is authorized to be appropriated to carry out part EE $75,000,000 for each of fiscal years 2018 through 2022.. 3307. Drug court training and technical assistance Section 705 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1704) is amended by adding at the end the following— (e) Drug Court Training and Technical Assistance Program Using funds appropriated to carry out this title, the Director may make grants to nonprofit organizations for the purpose of providing training and technical assistance to drug courts. . 3308. Drug overdose response strategy Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706) is amended by adding at the end the following: (r) Drug overdose response strategy implementation The Director may use funds appropriated to carry out this section to implement a drug overdose response strategy in high intensity drug trafficking areas on a nationwide basis by— (1) coordinating multi-disciplinary efforts to prevent, reduce, and respond to drug overdoses, including the uniform reporting of fatal and non-fatal overdoses to public health and safety officials; (2) increasing data sharing among public safety and public health officials concerning drug-related abuse trends, including new psychoactive substances, and related crime; and (3) enabling collaborative deployment of prevention, intervention, and enforcement resources to address substance use addiction and narcotics trafficking. . 3309. Protecting law enforcement officers from accidental exposure Section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1706), as amended by section 3308, is amended by adding at the end the following: (s) Supplemental grants The Director is authorized to use not more than $10,000,000 of the amounts otherwise appropriated to carry out this section to provide supplemental competitive grants to high intensity drug trafficking areas that have experienced high seizures of fentanyl and new psychoactive substances for the purposes of— (1) purchasing portable equipment to test for fentanyl and other substances; (2) training law enforcement officers and other first responders on best practices for handling fentanyl and other substances; and (3) purchasing protective equipment, including overdose reversal drugs. . 3310. COPS Anti-Meth Program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10381) is amended— (1) by redesignating subsection (k) as subsection (l); and (2) by inserting after subsection (j) the following: (k) COPS Anti-Meth Program The Attorney General shall use amounts otherwise appropriated to carry out this section to make competitive grants, in amounts of not less than $1,000,000 for a fiscal year, to State law enforcement agencies with high seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures for the purpose of locating or investigating illicit activities, such as precursor diversion, laboratories, or methamphetamine traffickers. . 3311. COPS anti-heroin task force program Section 1701 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10381) is amended— (1) by redesignating subsection (l), as so redesignated by section 3310, as subsection (m); and (2) by inserting after subsection (k), as added by section 3310, the following: (l) Cops anti-heroin task force program The Attorney General shall use amounts otherwise appropriated to carry out this section, or other amounts as appropriated, to make competitive grants to State law enforcement agencies in States with high per capita rates of primary treatment admissions, for the purpose of locating or investigating illicit activities, through Statewide collaboration, relating to the distribution of heroin, fentanyl, or carfentanil or relating to the unlawful distribution of prescription opioids. . 3312. Comprehensive Addiction and Recovery Act education and awareness Title VII of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198; 130 Stat. 735) is amended by adding at the end the following: 709. Services for families and patients in crisis (a) In general The Attorney General may make grants to entities that focus on addiction and substance use disorders and specialize in family and patient services, advocacy for patients and families, and educational information. (b) Allowable uses A grant awarded under this section may be used for private, nonprofit national organizations that engage in all of the following activities: (1) Expansion of phone line or call center services with professional, clinical staff that provide, for families and individuals impacted by a substance use disorder, support, access to treatment resources, brief assessments, medication and overdose prevention education, compassionate listening services, recovery support or peer specialists, bereavement and grief support, and case management. (2) Continued development of health information technology systems that leverage new and upcoming technology and techniques for prevention, intervention, and filling resource gaps in communities that are underserved. (3) Enhancement and operation of treatment and recovery resources, easy-to-read scientific and evidence-based education on addiction and substance use disorders, and other informational tools for families and individuals impacted by a substance use disorder and community stakeholders, such as law enforcement agencies. (4) Provision of training and technical assistance to State and local governments, law enforcement agencies, health care systems, research institutions, and other stakeholders. (5) Expanding upon and implementing educational information using evidence-based information on substance use disorders. (6) Expansion of training of community stakeholders, law enforcement officers, and families across a broad-range of addiction, health, and related topics on substance use disorders, local issues and community-specific issues related to the drug epidemic. (7) Program evaluation. (c) Authorization of appropriations For each of fiscal years 2018 through 2022, the Attorney General is authorized to award not more than $10,000,000 of amounts otherwise appropriated to the Attorney General for comprehensive opioid abuse reduction activities for purposes of carrying out this section. . 3313. Protecting children with addicted parents Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following: 550. Protecting children with addicted parents (a) Best practices The Secretary, acting through the Assistant Secretary and in cooperation with the Commissioner of the Administration on Children, Youth and Families, shall collect and disseminate best practices for States regarding interventions and strategies to keep families affected by a substance use disorder together, when it can be done safely. Such best practices shall— (1) utilize comprehensive family-centered approaches; (2) ensure that families have access to drug screening, substance use disorder treatment, medication-assisted treatment approved by the Food and Drug Administration, and parental support; and (3) build upon lessons learned from— (A) programs such as the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act; and (B) identifying substance abuse prevention and treatment services that meet the requirements for promising, supported, or well-supported practices specified in section 471(e)(4)(C) of the Social Security Act (as such section shall be in effect beginning on October 1, 2018). (b) Grant program The Secretary shall award grants to States, units of local government, and tribal governments to— (1) develop programs and models designed to keep pregnant and post-partum women who have a substance use disorder together with their newborns, including programs and models that provide for screenings of pregnant and post-partum women for substance use disorders, treatment interventions, supportive housing, nonpharmacological interventions for children born with neonatal abstinence syndrome, medication assisted treatment, and other recovery supports; and (2) support the attendance of children who have a family member living with a substance use disorder at therapeutic camps or other therapeutic programs aimed at addiction prevention education and delaying the onset of first use, providing trusted mentors and education on coping strategies that these children can use in their daily lives, and family support initiatives aimed at keeping these families together. . 3314. Reimbursement of substance use disorder treatment professionals Not later than January 1, 2020, the Comptroller General of the United States shall submit to Congress a report examining how substance use disorder services are reimbursed. 3315. Sobriety Treatment and Recovery Teams (START) Title V of the Public Health Service Act (42 U.S.C. 290dd et seq.), as amended by section 3313, is further amended by adding at the end the following: 551. Sobriety Treatment and Recovery Teams (a) In general The Secretary may make grants to States, units of local government, or tribal governments to establish or expand Sobriety Treatment And Recovery Team (referred to in this section as START) or other similar programs to determine the effectiveness of pairing social workers or mentors with families that are struggling with a substance use disorder and child abuse or neglect in order to help provide peer support, intensive treatment, and child welfare services to such families. (b) Allowable uses A grant awarded under this section may be used for one or more of the following activities: (1) Training eligible staff, including social workers, social services coordinators, child welfare specialists, substance use disorder treatment professionals, and mentors. (2) Expanding access to substance use disorder treatment services and drug testing. (3) Enhancing data sharing with law enforcement agencies, child welfare agencies, substance use disorder treatment providers, judges, and court personnel. (4) Program evaluation and technical assistance. (c) Program requirements A State, unit of local government, or tribal government receiving a grant under this section shall— (1) serve only families for which— (A) there is an open record with the child welfare agency; and (B) substance use disorder was a reason for the record or finding described in paragraph (1); and (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social Security Act focused on improving outcomes for children affected by substance abuse. (d) Technical assistance The Secretary may reserve not more than 5 percent of funds provided under this section to provide technical assistance on the establishment or expansion of programs funded under this section from the National Center on Substance Abuse and Child Welfare. (e) Authorization of appropriations For each of fiscal years 2018 through 2022, the Secretary is authorized to award not more than $10,000,000 of amounts otherwise appropriated to the Secretary for comprehensive opioid abuse reduction activities for purposes of carrying out this section. . 3316. Provider education Not later than 60 days after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall complete the plan related to medical registration coordination required by Senate Report 114–239, which accompanied the Veterans Care Financial Protection Act of 2017 (Public Law 115–131; 132 Stat. 334). 3317. Demand reduction Section 702(1) of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701(1)) is amended— (1) by redesignating subparagraphs (F) through (J) as subparagraphs (G) through (K), respectively; and (2) by inserting after subparagraph (E) the following: (F) support for long-term recovery from substance use disorders; . 3318. Anti-drug media campaign Section 709 of the Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1708) is amended— (1) in the section heading, by striking youth; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking youth; (B) in paragraph (1), by striking young; (C) in paragraph (2), by striking of adults of the impact of drug abuse on young people and inserting among the population about the impact of drug abuse; and (D) in paragraph (3), by striking parents and other interested adults to discuss with young people and inserting interested persons to discuss; and (3) in subsection (b)(2)(C)(ii), by striking among youth. 3319. Technical corrections to the office of national drug control policy reauthorization act of 1998 The Office of National Drug Control Policy Reauthorization Act of 1998 (21 U.S.C. 1701 et seq.) is amended— (1) in section 703(b)(3)(E) (21 U.S.C. 1702(b)(3)(E))— (A) in clause (i), by adding and at the end; (B) in clause (ii), by striking ; and and inserting a period; and (C) by striking clause (iii); (2) in section 704 (21 U.S.C. 1703)— (A) in subsection (c)(3)(C)— (i) in clause (v), by adding and at the end; (ii) in clause (vi), by striking ; and and inserting a period; and (iii) by striking clause (vii); and (B) in subsection (f)— (i) by striking the first paragraph (5); and (ii) by striking the second paragraph (4); (3) in section 706(a)(2)(A) (21 U.S.C. 1705(a)(2)(A))— (A) by striking clause (ix); and (B) by redesignating clauses (x) through (xiv) as clauses (ix) through (xiii), respectively; and (4) by striking section 708 (21 U.S.C. 1707). D Synthetic Abuse and Labeling of Toxic Substances 3401. Short title This subtitle may be cited as the Synthetic Abuse and Labeling of Toxic Substances Act of 2017 or the SALTS Act. 3402. Controlled substance analogues Section 203 of the Controlled Substances Act (21 U.S.C. 813) is amended— (1) by striking A controlled and inserting (a) In general.—A controlled; and (2) by adding at the end the following: (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), evidence related to the following factors may be considered, along with all other relevant evidence: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (c) Limitation For purposes of this section, the existence of evidence that a substance was not marketed, advertised, or labeled for human consumption shall not preclude the Government from establishing, based on all the evidence, that the substance was intended for human consumption. . E Opioid Quota Reform 3501. Short title This subtitle may be cited as the Opioid Quota Reform Act. 3502. Strengthening considerations for DEA opioid quotas (a) In general Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended— (1) in subsection (a)— (A) by inserting (1) after (a); (B) in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production; and (C) by adding at the end the following: (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. ; (2) in subsection (b), in the first sentence, by striking production and inserting manufacturing; (3) in subsection (c), by striking October and inserting December; and (4) by adding at the end the following: (i) (1) (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States. (B) In estimating diversion under this paragraph, the Attorney General— (i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. (C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. (2) (A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States. (B) Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Caucus on International Narcotics Control, the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance: (i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance. (ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year. (3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will— (A) take into consideration changes in the accepted medical use of the covered controlled substances; and (B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. . (b) Conforming change The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking production and inserting manufacturing. F Preventing Drug Diversion 3601. Short title This subtitle may be cited as the Preventing Drug Diversion Act of 2018. 3602. Improvements to prevent drug diversion (a) Definition Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following: (57) The term suspicious order includes— (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; (C) orders of controlled substances of unusual frequency; and (D) an order having any characteristic that would indicate to a reasonable registrant that it is suspicious or not legitimate. . (b) Suspicious orders Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is amended by adding at the end the following: 312. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database (1) In general Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders. (2) Satisfaction of reporting requirements If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (c) Sharing information with the States (1) In general The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State. (2) Timing The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law. . (c) Reports to Congress (1) Definition In this subsection, the term suspicious order has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this subtitle. (2) One time report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include— (A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders; (B) a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States; (C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and (D) descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity. (3) Additional reports Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year— (A) the number of reports of suspicious orders; (B) a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and (C) a description of the information shared with States based on reports of suspicious orders. (4) One time GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms— (A) would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real-time to suppliers before orders are filled; (B) may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and (C) would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids. G Sense of Congress 3701. Sense of Congress It is the sense of Congress that: (1) Americans with substance use disorders often seek treatment through recovery homes and clinical treatment facilities that offer detoxification, risk reduction, outpatient treatment, residential treatment, or rehabilitation for substance use. Most of those facilities provide a critical function in addressing substance misuse and abuse, particularly as the incidence and prevalence of substance use disorders, and drug overdose numbers continue to rise. (2) Despite the necessity of such treatment facilities and the important services most provide, there are some bad actors in the industry who, through telemarketing and other schemes, actively recruit patients with private insurance so that programs can bill the insurers without providing the necessary treatment services. Often these patient brokers are paid for each patient successfully recruited. Payments are also made as a percentage of billings, which incentivizes brokers to recommend patients even at low risk levels to the most aggressive and most expensive treatment programs. (3) Unless the patient is enrolled in a Federal health care program, a gap in Federal law exists with respect to patient brokers who are improperly recruiting unsuspecting patients to defraud insurance companies. (4) It is important that Congress provide a mechanism to penalize these bad actors, while minding legitimate entities who continue to help patients find reputable treatment programs. IV Commerce A Fighting Opioid Abuse in Transportation 4101. Short title This subtitle may be cited as the Fighting Opioid Abuse in Transportation Act. 4102. Rail mechanical employee controlled substances and alcohol testing (a) Rail mechanical employees Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a final rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to designate a rail mechanical employee as a railroad employee responsible for safety-sensitive functions for purposes of that section. (b) Definition of rail mechanical employee The Secretary shall define the term rail mechanical employee by regulation under subsection (a). (c) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the discretion of the Secretary of Transportation to set different requirements by railroad size or other factors, consistent with applicable law. 4103. Rail yardmaster controlled substances and alcohol testing (a) Yardmasters Not later than 2 years after the date of enactment of this Act, the Secretary of Transportation shall publish a final rule in the Federal Register revising the regulations promulgated under section 20140 of title 49, United States Code, to designate a yardmaster as a railroad employee responsible for safety-sensitive functions for purposes of that section. (b) Definition of yardmaster The Secretary shall define the term yardmaster by regulation under subsection (a). (c) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the discretion of the Secretary of Transportation to set different requirements by railroad size or other factors, consistent with applicable law. 4104. Department of Transportation public drug and alcohol testing database (a) In general Subject to subsection (c), the Secretary of Transportation shall— (1) not later than March 31, 2019, establish and make publicly available on its website a database of the drug and alcohol testing data reported by employers for each mode of transportation; and (2) update the database annually. (b) Contents The database under subsection (a) shall include, for each mode of transportation— (1) the total number of drug and alcohol tests by type of substance tested; (2) the drug and alcohol test results by type of substance tested; (3) the reason for the drug or alcohol test, such as pre-employment, random, post-accident, reasonable suspicion or cause, return-to-duty, or follow-up, by type of substance tested; and (4) the number of individuals who refused testing. (c) Commercially sensitive data The Department of Transportation shall not release any commercially sensitive data furnished by an employer under this section unless the data is aggregated or otherwise in a form that does not identify the employer providing the data. (d) Savings clause Nothing in this section may be construed as limiting or otherwise affecting the requirements of the Secretary of Transportation to adhere to requirements applicable to confidential business information and sensitive security information, consistent with applicable law. 4105. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data (a) In general Not later than 2 years after the date the Department of Transportation public drug and alcohol testing database is established under section 4104, the Comptroller General of the United States shall— (1) review the Department of Transportation Drug and Alcohol Testing Management Information System; and (2) submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on the review, including recommendations under subsection (c). (b) Contents The report under subsection (a) shall include— (1) a description of the process the Department of Transportation uses to collect and record drug and alcohol testing data submitted by employers for each mode of transportation; (2) an assessment of whether and, if so, how the Department of Transportation uses the data described in paragraph (1) in carrying out its responsibilities; and (3) an assessment of the Department of Transportation public drug and alcohol testing database under section 4104. (c) Recommendations The report under subsection (a) may include recommendations regarding— (1) how the Department of Transportation can best use the data described in subsection (b)(1); (2) any improvements that could be made to the process described in subsection (b)(1); (3) whether and, if so, how the Department of Transportation public drug and alcohol testing database under section 4104 could be made more effective; and (4) such other recommendations as the Comptroller General considers appropriate. 4106. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl (a) Mandatory Guidelines for Federal Workplace Drug Testing Programs (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall determine whether a revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opioid category on the list of authorized drug testing to include fentanyl is justified, based on the reliability and cost-effectiveness of available testing. (2) Revision of guidelines If the expansion of the opioid category is determined to be justified under paragraph (1), the Secretary of Health and Human Services shall— (A) notify the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives of the determination; and (B) publish in the Federal Register, not later than 18 months after the date of the determination under that paragraph, a final notice of the revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs to expand the opioid category on the list of authorized drug testing to include fentanyl. (3) Report If the expansion of the opioid category is determined not to be justified under paragraph (1), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report explaining, in detail, the reasons the expansion of the opioid category on the list of authorized drugs to include fentanyl is not justified. (b) Department of Transportation drug-testing panel If the expansion of the opioid category is determined to be justified under subsection (a)(1), the Secretary of Transportation shall publish in the Federal Register, not later than 18 months after the date the final notice is published under subsection (a)(2), a final rule revising part 40 of title 49, Code of Federal Regulations, to include fentanyl in the Department of Transportation's drug-testing panel, consistent with the Mandatory Guidelines for Federal Workplace Drug Testing Programs as revised by the Secretary of Health and Human Services under subsection (a). (c) Savings provision Nothing in this section may be construed as— (1) delaying the publication of the notices described in sections 4107 and 4108 until the Secretary of Health and Human Services makes a determination or publishes a notice under this section; or (2) limiting or otherwise affecting any authority of the Secretary of Health and Human Services or the Secretary of Transportation to expand the list of authorized drug testing to include an additional substance. 4107. Status reports on hair testing guidelines (a) In general Not later than 30 days after the date of enactment of this Act, and every 180 days thereafter until the date that the Secretary of Health and Human Services publishes in the Federal Register a final notice of scientific and technical guidelines for hair testing in accordance with section 5402(b) of the Fixing America's Surface Transportation Act (Public Law 114–94; 129 Stat. 1312), the Secretary of Health and Human Services shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report on— (1) the status of the hair testing guidelines; (2) an explanation for why the hair testing guidelines have not been issued; (3) a schedule, including benchmarks, for the completion of the hair testing guidelines; and (4) an estimated date of completion of the hair testing guidelines. (b) Requirement To the extent practicable and consistent with the objective of the hair testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results of the individual being tested caused solely by the drug use of others and not caused by the drug use of the individual being tested. 4108. Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (a) Deadline Not later than December 31, 2018, the Secretary of Health and Human Services shall publish in the Federal Register a final notice of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, based on the notice of proposed mandatory guidelines published in the Federal Register on May 15, 2015 (80 Fed. Reg. 28054). (b) Requirement To the extent practicable and consistent with the objective of the testing described in subsection (a) to detect illegal or unauthorized use of substances by the individual being tested, the final notice of scientific and technical guidelines under that subsection, as determined by the Secretary of Health and Human Services, shall eliminate the risk of positive test results of the individual being tested caused solely by the drug use of others and not caused by the drug use of the individual being tested. (c) Rule of construction Nothing in this section may be construed as requiring the Secretary of Health and Human Services to reissue a notice of proposed mandatory guidelines to carry out subsection (a). 4109. Electronic recordkeeping (a) Deadline Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) ensure that each certified laboratory that requests approval for the use of completely paperless electronic Federal Drug Testing Custody and Control Forms from the National Laboratory Certification Program’s Electronic Custody and Control Form systems receives approval for those completely paperless electronic forms instead of forms that include any combination of electronic traditional handwritten signatures executed on paper forms; and (2) establish a deadline for a certified laboratory to request approval under paragraph (1). (b) Savings clause Nothing in this section may be construed as limiting or otherwise affecting any authority of the Secretary of Health and Human Services to grant approval to a certified laboratory for use of completely paperless electronic Federal Drug Testing Custody and Control Forms, including to grant approval outside of the process under subsection (a). (c) Electronic signatures Not later than 18 months after the date of the deadline under subsection (a)(2), the Secretary of Transportation shall issue a final rule revising part 40 of title 49, Code of Federal Regulations, to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. 4110. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse (a) In general Not later than 180 days after the date of enactment of this Act, and biannually thereafter until the compliance date, the Administrator of the Federal Motor Carrier Safety Administration shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a status report on implementation of the final rule for the Commercial Driver's License Drug and Alcohol Clearinghouse (81 Fed. Reg. 87686), including— (1) an updated schedule, including benchmarks, for implementing the final rule as soon as practicable, but not later than the compliance date; and (2) a description of each action the Federal Motor Carrier Safety Administration is taking to implement the final rule before the compliance date. (b) Definition of compliance date In this section, the term compliance date means the earlier of— (1) January 6, 2020; or (2) the date that the national clearinghouse required under section 31306a of title 49, United States Code, is operational. B Opioid Addiction Recovery Fraud Prevention 4201. Short title This subtitle may be cited as the Opioid Addiction Recovery Fraud Prevention Act of 2018. 4202. Definitions In this subtitle: (1) Opioid treatment product The term opioid treatment product means a product, including any supplement or medication, for use or marketed for use in the treatment, cure, or prevention of an opioid use disorder. (2) Opioid treatment program The term opioid treatment program means a program that provides treatment for people diagnosed with, having, or purporting to have an opioid use disorder. (3) Opioid use disorder The term opioid use disorder means a cluster of cognitive, behavioral, or physiological symptoms in which the individual continues use of opioids despite significant opioid-induced problems, such as adverse health effects. 4203. False or misleading representations with respect to opioid treatment programs and products (a) Unlawful activity It is unlawful to make any deceptive representation with respect to the cost, price, efficacy, performance, benefit, risk, or safety of any opioid treatment program or opioid treatment product. (b) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of subsection (a) shall be treated as a violation of a rule under section 18 of the Federal Trade Commission Act (15 U.S.C. 57a) regarding unfair or deceptive acts or practices. (2) Powers of the Federal Trade Commission (A) In general The Federal Trade Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this section. (B) Privileges and immunities Any person who violates subsection (a) shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated and made part of this section. (c) Enforcement by States (1) In general Except as provided in paragraph (4), in any case in which the attorney general of a State has reason to believe that an interest of the residents of the State has been or is threatened or adversely affected by any person who violates subsection (a), the attorney general of the State, as parens patriae, may bring a civil action on behalf of the residents of the State in an appropriate district court of the United States to obtain appropriate relief. (2) Rights of Federal Trade Commission (A) Notice to Federal Trade Commission (i) In general Except as provided in clause (iii), the attorney general of a State shall notify the Federal Trade Commission in writing that the attorney general intends to bring a civil action under paragraph (1) before initiating the civil action. (ii) Contents The notification required by clause (i) with respect to a civil action shall include a copy of the complaint to be filed to initiate the civil action. (iii) Exception If it is not feasible for the attorney general of a State to provide the notification required by clause (i) before initiating a civil action under paragraph (1), the attorney general shall notify the Federal Trade Commission immediately upon instituting the civil action. (B) Intervention by Federal Trade Commission The Federal Trade Commission may— (i) intervene in any civil action brought by the attorney general of a State under paragraph (1); and (ii) upon intervening— (I) be heard on all matters arising in the civil action; and (II) file petitions for appeal. (3) Investigatory powers Nothing in this subsection shall be construed to prevent the attorney general of a State from exercising the powers conferred on the attorney general by the laws of the State to conduct investigations, to administer oaths or affirmations, or to compel the attendance of witnesses or the production of documentary or other evidence. (4) Preemptive action by Federal Trade Commission If the Federal Trade Commission or the Attorney General on behalf of the Commission institutes a civil action, or the Federal Trade Commission institutes an administrative action, with respect to a violation of subsection (a), the attorney general of a State may not, during the pendency of that action, bring a civil action under paragraph (1) against any defendant or respondent named in the complaint of the Commission for the violation with respect to which the Commission instituted such action. (5) Venue; service of process (A) Venue Any action brought under paragraph (1) may be brought in any district court of the United States that meets applicable requirements relating to venue under section 1391 of title 28, United States Code. (B) Service of process In an action brought under paragraph (1), process may be served in any district in which the defendant— (i) is an inhabitant; or (ii) may be found. (6) Actions by other State officials In addition to civil actions brought by attorneys general under paragraph (1), any other consumer protection officer of a State who is authorized by the State to do so may bring a civil action under paragraph (1), subject to the same requirements and limitations that apply under this subsection to civil actions brought by attorneys general. (d) Authority preserved Nothing in this title shall be construed to limit the authority of the Federal Trade Commission or the Food and Drug Administration under any other provision of law. Secretary