Preamble. IOpioid Crisis Response Act1001.DefinitionsIn this title—(1)the terms Indian Tribe and tribal organization have the m...
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IOpioid Crisis Response Act1001.DefinitionsIn 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.AReauthorization of Cures Funding1101.State response to the opioid abuse crisis(a)In generalSection 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)DefinitionFor 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 mechanismsThe 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 CongressNot 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 AssistanceThe 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 appropriationsFor 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 asideOf 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 amendmentSection 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.BResearch and Innovation1201.Advancing cutting-edge researchSection 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 researchSection 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)ReportThe 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 generalNot 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 definedFor 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))).CMedical Products and Controlled Substances Safety1301.Clarifying FDA regulation of non-addictive pain products(a)Public MeetingsNot 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)GuidanceNot 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)DefinitionsIn 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 strategySection 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 disposalThe 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 burdenSection 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 applicationsSection 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 generalThe 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 generalIn 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 technologyAny 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)ReportNot 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 appropriationsOut 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 authoritiesSection 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 generalThe 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 generalSection 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 actSection 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 exportsSection 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 articlesSection 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 generalFor 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)EffectThis 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 trainingSection 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 sectorsIn 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 generalSection 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 requiredSection 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)GuidanceThe 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 authorityNothing 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 generalThe 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)ContentsIn 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)ReportNot 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 generalThe 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 generalNotwithstanding 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 periodDuring 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 reportAfter 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 daysAny modification under this subsection shall be for a period of not less than 7 days..(b)Study and reportNot 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 amendmentThe 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..DTreatment and Recovery1401.Comprehensive opioid recovery centers(a)In generalThe 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 generalA grant awarded under subsection
(a)shall be for a period not more than 5 years.(2)RenewalA 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 grantsThe 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 entityAn 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 applicationIn 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)PriorityIn 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)PreferenceIn 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 activitiesEach 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 servicesEach 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)OutreachEach 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 oversightWith 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)PrivacyThe 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 appropriationsThere 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 reportNot 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 reportNot 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 generalThe 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 generalThe 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 entityIn 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)ApplicationAn 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 fundsAn 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 usesIn 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)PreferenceIn 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 grantA grant awarded to an eligible entity under this section shall be for a period of not more than 5 years.(c)DefinitionsIn this section:(1)Recovery coachthe 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 organizationThe 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 agencyThe 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 granteesEach 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 SecretaryNot 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)PrivacyThe 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 appropriationsThere 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 generalThe 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 generalThe Secretary shall award grants to hospitals and other acute care settings relating to alternatives to opioids for pain management.(2)Authorization of appropriationsThere 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 recoverySection 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)DefinitionIn 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 authorizedThe Secretary shall award grants to recovery community organizations to enable such organizations to develop, expand, and enhance recovery services.(c)Federal shareThe Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent.(d)Use of fundsGrants 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 considerationIn 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 appropriationsThere 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)EstablishmentThe 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)FunctionsThe 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 practicesThe Center established under subsection
(a)shall periodically issue best practices for use by recovery community organizations and peer support networks.(d)Recovery community organizationIn 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 appropriationsThere 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 detoxificationSection 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 childrenThe 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 amendmentSection 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 generalThe 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 appropriationsThere 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 disordersSubclause
(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 generalThe 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)ConsultationIn 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 generalThe 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)ConsultationIn 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 reportingIn 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 consideredIn 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)DisseminationThe 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)RequirementsIn 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 constructionNothing 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)DefinitionsIn 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)DefinitionsExcept as otherwise expressly provided, in this section:(1)WIOA definitionsThe 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 providerThe 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 entityThe term eligible entity means—(A)a State workforce agency;(B)an outlying area; or(C)a Tribal entity.(4)Participating partnershipThe 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 participantThe 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 servicesThe 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)SecretaryThe term Secretary means the Secretary of Labor.(8)State workforce agencyThe 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 disorderThe term substance use disorder has the meaning given such term by the Assistant Secretary for Mental Health and Substance Use.(10)Treatment providerThe 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 entityThe 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 generalThe 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 amountsThe 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 generalAn 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)DemonstrationAn 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)InformationTo 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 strategyThe 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)DemonstrationAn 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)InformationTo 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 generalAn 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 distributionIn 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 distributionAn 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 generalA 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)ContentsEach 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 generalEach 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 servedA 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 activitiesEach participating partnership shall use funds available through a subgrant under this subsection to carry out 1 or more of the following:(A)Engaging employersEngaging 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 servicesProviding 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 planDeveloping 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 careIn 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 servicesProviding 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 servicesOffering 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 practicesLeading 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)LimitationsA 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)ReportsThe 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 agreementsThe 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 usedThe 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 yearIn this subsection, the term covered fiscal year means any of fiscal years 2018 through 2023.(2)Using funding for national dislocated worker grantsSubject 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 fundsFunds 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)LimitationThe 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 generalThe 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 authorizedIn 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)PriorityIn 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)PreferenceIn 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)ApplicationsAn 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 fundsAn 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 strategyAn 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 appropriationsThere 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 appropriationsThere 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 generalThe 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)CriteriaThe 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)DistributionAmounts 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 generalAny 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)PriorityAny 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 costsAny 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 generalExcept 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 matchNo 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 generalIn 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)NoticeThe 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 assistanceFor 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)StateFor 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 adultsSection 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 centerThe 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 generalThe 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)DefinitionsIn this subsection:(A)Eligible entityThe 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-basedThe 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 careThe 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 schoolThe 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 youthThe 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 educationThe 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 agencyThe 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 operatorThe 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 YouthThe 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 programThe 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 AgencyThe 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 practicesThe 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 authorizedThe 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 considerationIn awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations.(6)ApplicationTo 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)PriorityIn 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 SecretaryEach 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 CongressThe 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 appropriationsThere 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 careSection 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 authorizedThe 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)ReservationsOf 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 territoriesThe 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 reductionIf 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)ApplicationA 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 fundsFunds 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)ReportingEach 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 congressThe 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 fundsThe 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 appropriationsTo 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 telemedicineSection 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 generalNot 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)ProcedureIn 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 settingsSubpart 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 settingsAn 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 generalAny 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)LimitationThe 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 constructionThe 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 providersThe 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 treatmentIn 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 appropriationsThere 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 generalNot 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 updatesThe Secretary shall periodically update the report under paragraph (1).(b)Residential treatment programs for pregnant and postpartum womenSection 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 PreventionSection 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 TreatmentSection 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 TreatmentSection 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 generalSection 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)ApplicabilityThe 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.EPrevention1501.Study on prescribing limitsNot 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 careSection 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 programSection 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 campaignsSection 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 generalThe 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 disseminationPart 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 generalThe 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 activitiesA 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)DefinitionsIn 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 substancesPart 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 generalThe 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 activitiesA 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 grantsThe 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)ResearchThe 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 educationPursuant 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)DefinitionsIn 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 appropriationsFor 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 collectionThe 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)TimingThe collection of data under subsection
(a)may occur in fiscal year 2019 and every 2 years thereafter.(c)Data from rural areasThe 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 areasThe 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 appropriationsTo 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 NASPERSection 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 generalIn 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 interoperabilityFor 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 generalNot 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)DisseminationThe Secretary shall disseminate the best practices developed under paragraph
(1)to health care providers and State agencies.(b)RequirementsIn 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 materialsNot 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)RequirementsThe 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 updatesThe 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 entitiesIn identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders.(e)Authorization of appropriationsThere 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 EmergenciesThe 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 materialFor 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 healthSection 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 activitiesTo 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 factorsSection 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)EstablishmentThere 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)CompositionThe 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 appointmentsThe 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)ChairpersonThe task force shall be chaired by the Assistant Secretary for Mental Health and Substance Use.(c)Task force dutiesThe 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 practicesIn 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 planNot 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 reportNot 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)DefinitionIn 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 appropriationsTo 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)SunsetThe 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 authorizedThe 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)DurationWith 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 fundsAn 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)ApplicationsTo 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 agencyA 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)ContentsThe 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)EvaluationThe 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 awardsThe 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 constructionNothing 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 supplantAny 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 TribesIn 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)DefinitionsIn this section:(1)Elementary or secondary schoolThe 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-basedThe 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 organizationThe 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 servicesThe 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 leaderThe 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)SecretaryThe term Secretary means the Secretary of Education.(7)Specialized instructional support personnelThe 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 appropriationsThere 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 InitiativeSection 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 generalNot 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 crisisThe 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 disordersIn 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 periodIf 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 updateNot 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. — Actions: September 17, 2018.
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U.S. Code
- Definitions§ 5304
- Director of National Institutes of Health§ 282
- Pain research§ 284q
- Definitions§ 802
- New drugs§ 355
- Registration of producers of drugs or devices§ 360
- Premarket approval§ 360e
- Utilizing real world evidence§ 355g
- Expedited approval of drugs for serious or life-threatening diseases or conditions§ 356
- Definitions; generally§ 321
- Regulation of biological products§ 262
- Congressional findings and declarations: controlled substances§ 801
- Definitions§ 951
- Short title§ 301
- Debarment, temporary denial of approval, and suspension§ 335a
- Miscellaneous§ 1401
- Prohibited acts§ 331
- Imports and exports§ 381
- Persons required to register§ 822
- Definitions§ 1395x
- Prescriptions§ 829
- Payments to hospitals for inpatient hospital services§ 1395ww
- Registration requirements§ 823
- Definitions§ 4103
- Definitions§ 3102
- General definition of institution of higher education§ 1001
- Definition of institution of higher education for purposes of student assistance programs§ 1002
- General authorization§ 3161
- Medicaid and CHIP Payment and Access Commission§ 1396
- Definitions§ 1603
- Definitions§ 11711
- Native American programs§ 3221
- Performance accountability system§ 3141
- Purposes§ 3101
- Additional definitions§ 1003
- General authorization§ 3171
- Use of funds for employment and training activities§ 3174
- State allotments§ 3172
- National dislocated worker grants§ 3225
- Authorization of appropriations§ 3227
- Authorization of appropriations§ 3181
- Provision of comprehensive economic development strategies to Regional Commissions§ 3174
- Congressional findings and declaration of purpose§ 5301
- General provisions§ 5302
- Definitions§ 7801
- Definitions§ 11434a
- Use of funds for youth workforce investment activities§ 3164
- Grants to States, Indian tribes or tribal organizations, and public or private agencies and organizations§ 5106
- Authorization of appropriations; purposes; definitions§ 701
- Findings and policy§ 1431
- Maternal, infant, and early childhood home visiting programs§ 711
- Congressional declaration of purpose; authorization of appropriations§ 670
- Purpose§ 621
- Additional requirements relating to online pharmacies and telemedicine§ 831
- National Health Service Corps Scholarship Program§ 254l
- Health professional shortage areas§ 254e
- National Health Service Corps§ 254d
- Center for Substance Abuse Treatment§ 290bb
- Schedules of controlled substances§ 812
- Program for education and training in pain care§ 294i
- Research§ 280b
- Definitions§ 1602
- Definitions§ 7517
- Full-service community schools§ 7275
- Short title; findings; purposes§ 1400
23 references not yet in our index
- 21 USC 360bbb–8c
- 21 USC 355–1(e)
- 21 USC 355–1(f)(2)(C)
- 21 USC 355–1(i)
- 21 USC 355–1(b)(1)(E)
- 42 USC 290ee–1
- 130 Stat. 1395
- 42 USC 290ee–2(a)
- 42 USC 300x–21
- 42 USC 290ee–2
- 42 USC 290bb–7
- 42 USC 300x–27
- 42 USC 254l–1
- 42 USC 290bb–1(s)
- 42 USC 290bb–21(b)
- 42 USC 294e–1(a)
- 42 USC 280b–1
- 42 USC 280g–3
- 42 USC 290dd–2
- 42 USC 1320d–2
- 42 USC 247b–13
- 42 USC 247b–15
- 42 USC 290hh–1(j)
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Preamble
IOpioid Crisis Response Act1001.DefinitionsIn this title—(1)the terms Indian Tribe and tribal organization have the m...
Cite21 USC 360bbb–8c
Cite21 USC 355–1(e)
Cite21 USC 355–1(f)(2)(C)
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