Comprehensive Addiction Resources Emergency Act of 2021

Bill: 117-s-3418
Sponsor: full_name: Sen. Warren, Elizabeth [D-MA]
Introduced: 2021-12-16
Policy area: Health
Latest action: action_date: 2021-12-16
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-12-16
action_desc: Introduced in Senate
text: <p><strong>Comprehensive Addiction Resources Emergency Act of 2021</strong></p> <p>This bill establishes programs, grants, and other activities to address substance use disorders.</p> <p>Specifically, the Department of Health and Human Services (HHS) must establish a program for purchasing and distributing opioid overdose reversal drugs for states and Indian tribes.</p> <p>HHS must also award grants for and otherwise support</p> <ul> <li>addressing substance use, particularly in states, tribes, territories, and localities with disproportionately high drug overdose rates;</li> <li>increasing access to preventive, medical, recovery, and related services;</li> <li>developing innovative models of delivering treatment and harm reduction services; and</li> <li>expanding the treatment capacity of Medicaid providers.</li> </ul> <p>In addition, HHS must issue model standards of care for treatment services and recovery residences and may award grants for training health care professionals. The bill also supports prevention and treatment services for workers, addiction and pain management research, and data collection on substance use disorders.</p> <p>Further, dispensers, distributors, and manufacturers of schedule II controlled substances (e.g., oxycodone), with the exception of opioid treatment programs, must certify that they maintain effective drug diversion controls. Violators are subject to specified civil and criminal penalties. Collected penalties shall be used for the grant programs and other substance use disorder activities established under the bill.</p>

tv_txt: II 117th CONGRESS 1st Session S. 3418 IN THE SENATE OF THE UNITED STATES December 16, 2021 Ms. Warren (for herself, Ms. Baldwin , Mr. Van Hollen , Mr. Casey , Ms. Klobuchar , Mr. Sanders , Mr. Markey , Mr. Blumenthal , Mr. Padilla , Mr. Booker , Ms. Smith , Mr. Brown , Mr. Heinrich , and Mr. Merkley ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide emergency assistance to States, territories, Tribal nations, and local areas affected by substance use disorder, including the use of opioids and stimulants, and to make financial assistance available to States, territories, Tribal nations, local areas, public or private nonprofit entities, and certain health providers, to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families.

1. Short title; table of contents (a) Short title This Act may be cited as the Comprehensive Addiction Resources Emergency Act of 2021 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Purpose. Sec. 3. Amendment to the Public Health Service Act. TITLE XXXIV—Substance use resources Subtitle A—Local substance use emergency relief grant program Sec. 3401. Establishment of program of grants. Sec. 3402. Planning council. Sec. 3403. Amount of grant, use of amounts, and funding agreement. Sec. 3404. Application. Sec. 3405. Technical assistance. Sec. 3406. Authorization of appropriations. Subtitle B—State and tribal substance use disorder prevention and intervention grant program Sec. 3411. Establishment of program of grants. Sec. 3412. Amount of grant, use of amounts, and funding agreement. Sec. 3413. Application. Sec. 3414. Technical assistance. Sec. 3415. Authorization of appropriations. Subtitle C—Other grant program Sec. 3421. Establishment of grant program. Sec. 3422. Use of amounts. Sec. 3423. Technical assistance. Sec. 3424. Planning and development grants. Sec. 3425. Authorization of appropriations. Subtitle D—Innovation, training, and health systems strengthening Sec. 3431. Special projects of national significance. Sec. 3432. Education and training centers. Sec. 3433. Substance use disorder treatment provider capacity under the Medicaid program. Sec. 3434. Programs to support employees. Sec. 3435. Improving and expanding care. Sec. 3436. Naloxone distribution program. Sec. 3437. Additional funding for the National Institutes of Health. Sec. 3438. Additional funding for the Centers for Disease Control and Prevention. Sec. 3439. Definitions. Sec. 4. Amendments to the Controlled Substances Act. Sec. 5. General limitation on use of funds. Sec. 6. Federal drug demand reduction activities. 2. Purpose It is the purpose of this Act to provide emergency assistance to States, territories, Tribal nations, and local areas that are disproportionately affected substance use disorder, including the use of opioids and stimulants, and to make financial assistance available to States, territories, Tribal nations, local areas, public or private nonprofit entities, and certain health providers, to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder, including with co-occurring mental health and substance use disorders, and their families. 3. Amendment to the Public Health Service Act The Public Health Service Act ( 42 U.S.C. 201 et seq. ) is amended by adding at the end the following: XXXIV Substance use resources A Local substance use emergency relief grant program 3401. Establishment of program of grants (a) In general The Secretary shall award grants to eligible localities for the purpose of addressing substance use within such localities. (b) Eligibility (1) In general To be eligible to receive a grant under subsection (a) a locality shall— (A) be— (i) a county that can demonstrate that the rate of drug overdose deaths per 100,000 population in the county during the most recent 3-year period for which such data are available was not less than the rate of such deaths for the county that ranked at the 67th percentile of all counties, as determined by the Secretary; (ii) a county that can demonstrate that the number of drug overdose deaths during the most recent 3-year period for which such data are available was not less than the number of such deaths for the county that ranked at the 90th percentile of all counties, as determined by the Secretary; (iii) a county that encompasses an undeserved area, defined as a health professional shortage area (as defined in section 332(a)(1)(A)) and a medically underserved area (according to a designation under section 330(b)(3)(A)), that can demonstrate a high burden of both fatal and non-fatal drug overdoses in a manner determined by the Secretary; or (iv) a city that is located within a county described in clause (i), (ii), or (iii) that meets the requirements of paragraph (3); and (B) submit to the Secretary an application in accordance with section 3404. (2) Multiple contiguous counties In the case of an eligible county that is contiguous to one or more other eligible counties within the same State, the group of counties shall— (A) be considered as a single eligible county for purposes of a grant under this section; (B) submit a single application under section 3404; (C) form a joint planning council (for the purposes of section 3402); and (D) establish, through intergovernmental agreements, an administrative mechanism to allocate funds and substance use disorder treatment services under the grant based on— (i) the number and rate of drug overdose deaths and nonfatal drug overdoses in each of the counties that compose the eligible county; (ii) the severity of need for services in each such county; and (iii) the health and support personnel needs of each such county. (3) Cities and counties within multiple contiguous counties (A) In general A city that is within an eligible county described in paragraph (1), or a county or group of counties that is within a group of counties determined to be an eligible county under paragraph (2), shall be eligible to receive a grant under section 3401 if such city or county or group of counties meets the requirements of subparagraph (B). (B) Requirements A city or county meets the requirements of this subparagraph if such city or county— (i) except as provided in subparagraph (C), has a population of not less than 50,000 residents; (ii) meets the requirements of paragraph (1)(A); (iii) submits an application under section 3404; (iv) establishes a planning council (for purposes of section 3402); and (v) establishes an administrative mechanism to allocate funds and services under the grant based on— (I) the number and rate of drug overdose deaths and nonfatal drug overdoses in the city or county; (II) the severity of need for substance use disorder treatment services in the city or county; and (III) the health and support personnel needs of the city or county. (C) Population exception A city or county or group of counties that does not meet the requirements of subparagraph (B)(i) may apply to the Secretary for a waiver of such requirement. Such application shall demonstrate— (i) that the needs of the population to be served are distinct or that addressing substance use in the service area would be best served by the formation of an independent council; and (ii) that the city or county or group of counties has the capacity to administer the funding received under this subtitle. (D) Minimum funding A city or county that meets the requirement of this paragraph and receives a grant under section 3401 shall be entitled to an amount of funding under the grant in an amount that is not less than the amount determined under section 3403(a) with respect to such city or county. (4) Independent city Independent cities that are not located within the territory of a county shall be treated as eligible counties for purposes of this subtitle. (5) Political subdivisions With respect to States that do not have a local county system of governance, the Secretary shall determine the local political subdivisions within such States that are eligible to receive a grant under section 3401 and such subdivisions shall be treated as eligible counties for purposes of this subtitle. (6) Determinations where there is a lack of data The Secretary shall establish eligibility and allocation criteria related to the prevalence of drug overdose deaths, the mortality rate from drug overdoses, and that provides an equivalent measure of need for funding for cities and counties for which the data described in paragraph (1)(A) or (2)(D)(i) is not available. (7) Data from tribal areas The Secretary, acting through the Indian Health Service, shall consult with Indian Tribes and confer with urban Indian organizations to establish eligibility and allocation criteria that provide an equivalent measure of need for Tribal and urban Indian areas for which the data described in paragraph (1)(A) or (2)(D)(i) are not available or do not apply. (8) Study Not later than 3 years after the date of enactment of this title, the Comptroller General shall conduct a study to determine whether the data utilized for purposes of paragraph (1)(A) provide the most precise measure of local area need related to substance use and addiction prevalence and whether additional data would provide more precise measures of substance use and addiction prevalence in local areas. Such study shall identify barriers to collecting or analyzing such data, and make recommendations for revising the indicators used under such paragraph to determine eligibility in order to direct funds to the local areas in most need of funding to provide assistance related to substance use and addiction. (9) Reference For purposes of this subtitle, the term eligible local area includes— (A) a city or county described in paragraph (1); (B) multiple contiguous counties described in paragraph (2); (C) cities or counties within multiple contiguous counties described in paragraph (3); (D) an independent city described in paragraph (4); and (E) a political subdivision described in paragraph (5). (c) Administration (1) In general Assistance made available under a grant awarded under this section shall be directed to the chief elected official of the eligible local area who shall administer the grant funds. (2) Multiple contiguous counties (A) In general Except as provided in subparagraph (B), in the case of an eligible county described in subsection (b)(2), assistance made available under a grant awarded under this section shall be directed to the chief elected official of the particular county designated in the application submitted for the grant under section 3404. Such chief elected official shall be the administrator of the grant. (B) State administration Notwithstanding subparagraph (A), the eligible county described in subsection (b)(2) may elect to designate the chief elected State official of the State in which the eligible county is located as the administrator of the grant funds. 3402. Planning council (a) Establishment To be eligible to receive a grant under section 3401, the chief elected official of the eligible local area shall establish or designate a substance use disorder treatment and services planning council that shall, to the maximum extent practicable— (1) be representative of the demographics of the population of individuals with substance use disorder in the area; and (2) include representatives of— (A) health care providers, including Federally-qualified health centers, rural health clinics, Indian health programs as defined in section 4 of the Indian Health Care Improvement Act, urban Indian organizations as defined in section 4 of the Indian Health Care Improvement Act, and facilities operated by the Department of Veterans Affairs; (B) Native Hawaiian organizations as defined in section 11 of the Native Hawaiian Health Care Act of 1988; (C) community-based health, harm reduction, or addiction service organizations, including, where applicable, representatives of Drug Free Communities Coalition grantees; (D) social service providers, including providers of housing and homelessness services and recovery residence providers; (E) mental health care providers; (F) local public health agencies; (G) individuals with substance use disorder and individuals who use drugs; (H) individuals in recovery from substance use disorders; (I) State governments, including the State Medicaid agency and the Single State Agency for Substance Abuse Services; (J) local governments; (K) non-elected community leaders; (L) substance use disorder treatment providers, including physician addiction specialists; (M) Indian tribes and tribal organizations as defined in section 4 of the Indian Self-Determination and Education Assistance Act; (N) Urban Indians as defined in section 4 of the Indian Health Care Improvement Act; (O) historically underserved groups and subpopulations; (P) individuals who were formerly incarcerated; (Q) organizations serving individuals who are currently incarcerated or in pre-trial detention or were formerly incarcerated; (R) Federal agencies; (S) organizations that provide drug prevention programs and services to youth at risk of substance use; (T) medical examiners or coroners; (U) labor unions and the workplace community; (V) local fire departments and emergency medical services; (W) the lesbian, gay, bisexual, transgender, queer (LGBTQ) community; and (X) certified or accredited addiction recovery community organizations. (b) Method of providing for council (1) In general In providing for a council for purposes of subsection (a), the chief elected official of the eligible local area may establish the council directly or designate an existing entity to serve as the council, subject to paragraph (2). (2) Consideration regarding designation of council In making a determination of whether to establish or designate a council under paragraph (1), the chief elected official shall give priority to the designation of an existing entity that has demonstrated experience in the provision of health and support services to individuals with substance use disorder within the eligible local area, that has a structure that recognizes the Federal trust responsibility when spending Federal health care dollars, and that has demonstrated a commitment to respecting the obligation of government agencies using Federal dollars to consult with Indian tribes and confer with urban Indian organizations. (3) Designation of existing entity If an existing entity is designated to serve as the council under this section, the membership of the entity shall comply with the requirements of subsection (a)(1) before it performs any of the duties set forth in subsection (e). (4) Joint council The Secretary shall establish a process to permit an eligible local area that is not contiguous with any other eligible local area to form a joint planning council with such other eligible local area or areas, as long as such areas are located in geographical proximity to each other, as determined by the Secretary, and submit a joint application under section 3404. (5) Joint council across State lines Eligible local areas may form a joint planning council with other eligible local areas across State lines if such areas are located in geographical proximity to each other, as determined by the Secretary, submit a joint application under section 3404, and establish intergovernmental agreements to allow the administration of the grant across State lines. (c) Membership Members of the planning council established or designated under subsection (a) shall— (1) be nominated and selected through an open process; (2) elect from among their membership a chair and vice chair; (3) include at least one representative from Indian tribes located within any eligible local area that receives funding under the grant program established in section 3401; (4) include at least 1 individual with a history of substance use disorder; (5) include at least 1 representative from a nonprofit substance use disorder service provider, at least 1 representative of an urban Indian organization, at least 1 physician addiction specialist, and at least 1 representative from an organization providing harm reduction services; (6) include at least 1 representative of a Native Hawaiian organization (as defined in section 11 of the Native Hawaiian Health Care Act of 1988) when the Native Hawaiian population exceeds 10 percent; and (7) serve not more than 3 consecutive years on the planning council. (d) Membership terms Members of the planning council established or designated under subsection (a) may serve additional terms if nominated and selected through the process established in subsection (c)(1). (e) Duties The planning council established or designated under subsection (a) shall— (1) establish priorities for the allocation of grant funds within the eligible local area that emphasize reducing drug use rates, overdose, substance use disorder, and health conditions associated with drug use such as human immunodeficiency virus, hepatitis B, and hepatitis C through evidence-based interventions in both community and criminal justice settings and that are based on— (A) the use by the grantee of substance use disorder prevention, intervention, treatment, and recovery strategies that comply with best practices identified by the Secretary; (B) the demonstrated or probable cost-effectiveness of proposed substance use disorder prevention, intervention, treatment, and recovery services; (C) the health priorities of the communities within the eligible local area that are affected by substance use; (D) the priorities and needs of individuals with substance use disorder; and (E) the availability of other governmental and non-governmental services; (2) ensure the use of grant funds will advance any existing State or local plan regarding the provision of substance use disorder treatment services to individuals with substance use disorder; (3) in the absence of a State or local plan, work with local public health agencies to develop a comprehensive plan for the organization and delivery of substance use disorder prevention and treatment services; (4) regularly assess the efficiency of the administrative mechanism in rapidly allocating funds to support evidence-based substance use disorder prevention and treatment services in the areas of greatest need within the eligible local area; (5) work with local public health agencies to determine the size and demographics of the population of individuals with substance use disorders and the types of substance use that are most prevalent in the eligible local area; (6) work with local public health agencies to determine the needs of such population, including the need for substance use disorder prevention, intervention, treatment, harm reduction, and recovery services; (7) work with local public agencies to determine the disparities in access to services among affected subpopulations and historically underserved communities, including infrastructure and capacity shortcomings of providers that contribute to these disparities; (8) work with local public agencies to establish methods for obtaining input on community needs and priorities, including by partnering with organizations that serve targeted communities experiencing high addictive substance-related health disparities to gather data using culturally attuned data collection methodologies; (9) coordinate with Federal grantees that provide substance use disorder prevention and treatment services within the eligible local area; and (10) annually assess the effectiveness of the substance use disorder prevention and treatment services being supported by the grant received by the eligible local area, including, to the extent possible— (A) reductions in the rates of substance use, overdose, and death from substance use; (B) rates of discontinuation from substance use disorder treatment services and rates of sustained recovery; (C) long-term outcomes among individuals receiving treatment for substance use disorders; and (D) the availability and use of substance use disorder treatment services needed by individuals with substance use disorders over their lifetimes. (f) Conflicts of interest (1) In general The planning council under subsection (a) may not be directly involved in the administration of a grant under section 3401. (2) Required agreements An individual may serve on the planning council under subsection (a) only if the individual agrees that if the individual has a financial interest in an entity, if the individual is an employee of a public or private entity, or if the individual is a member of a public or private organization, and such entity or organization is seeking amounts from a grant under section 3401, the individual will not, with respect to the purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the process of selecting entities to receive such amounts for such purpose. (g) Grievance procedures A planning council under subsection (a) shall develop procedures for addressing grievances with respect to funding under this subtitle, including procedures for submitting grievances that cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning council. (h) Public deliberations With respect to a planning council under subsection (a), in accordance with criteria established by the Secretary, the following applies: (1) The meetings of the council shall be open to the public and shall be held only after adequate notice to the public. (2) The records, reports, transcripts, minutes, agenda, or other documents which were made available to or prepared for or by the council shall be available for public inspection and copying at a single location. (3) Detailed minutes of each meeting of the council shall be kept. The accuracy of all minutes shall be certified to by the chair of the council. (4) This subparagraph does not apply to any disclosure of information of a personal nature that would constitute a clearly unwarranted invasion of personal privacy, including any disclosure of medical information or personnel matters. (i) Neutrality towards organized labor (1) In general In carrying out duties under subsection (e), planning councils shall, to the extent practicable, prioritize the distribution of grant funds to grantees that have— (A) (i) a collective bargaining agreement; or (ii) an explicit policy not to deter employees with respect to— (I) labor organizing for the employees engaged in the covered activities; and (II) such employees’ choice to form and join labor organizations; and (B) policies that require— (i) the posting and maintenance of notices in the workplace to such employees of their rights under the National Labor Relations Act ( 29 U.S.C. 151 et seq. ); (ii) that such employees are, at the beginning of their employment, provided notice and information regarding the employees’ rights under such Act; and (iii) the employer to voluntarily recognize a union in cases where a majority of such workers of the employer have joined and requested representation. (2) Limitation This subsection does not apply to Indian tribes. 3403. Amount of grant, use of amounts, and funding agreement (a) Amount of grant (1) Grants based on relative need of area (A) In general In carrying out this subtitle, the Secretary shall make a grant for each eligible local area for which an application under section 3404 has been approved. Each such grant shall be made in an amount determined in accordance with paragraph (3). (B) Expedited distribution Not later than 90 days after an appropriation becomes available to carry out this subtitle for a fiscal year, the Secretary shall disburse 53 percent of the amount made available under section 3406 for carrying out this subtitle for such fiscal year through grants to eligible local areas under section 3401, in accordance with subparagraphs (C) and (D). (C) Amount (i) In general Subject to the extent of amounts made available in appropriations Acts, a grant made for purposes of this subparagraph to an eligible local area shall be made in an amount equal to the product of— (I) an amount equal to the amount available for distribution under subparagraph (B) for the fiscal year involved; and (II) the percentage constituted by the ratio of the distribution factor for the eligible local area to the sum of the respective distribution factors for all eligible local areas, which product shall then, as applicable, be increased under subparagraph (D). (ii) Distribution factor For purposes of clause (i)(II), the term distribution factor means— (I) an amount equal to— (aa) the estimated number of drug overdose deaths in the eligible local area, as determined under clause (iii); or (bb) the estimated number of non-fatal drug overdoses in the eligible local area, as determined under clause (iv), as determined by the Secretary based on which distribution factor (item (aa) or (bb)) will result in the eligible local area receiving the greatest amount of funds; or (II) in the case of an eligible local area for which the data described in subclause (I) are not available, an amount determined by the Secretary— (aa) based on other data the Secretary determines appropriate; and (bb) that is related to the prevalence of non-fatal drug overdoses, drug overdose deaths, and the mortality rate from drug overdoses and provides an equivalent measure of need for funding. (iii) Number of drug overdose deaths The number of drug overdose deaths determined under this clause for an eligible county for a fiscal year for purposes of clause (ii) is the number of drug overdose deaths during the most recent 3-year period for which such data are available. (iv) Number of non-fatal drug overdoses The number of non-fatal drug overdose deaths determined under this clause for an eligible county for a fiscal year for purposes of clause (ii) may be determined by using data including emergency department syndromic data, visits, other emergency medical services for drug-related causes, or Overdose Detection Mapping Application Program (ODMAP) data during the most recent 3-year period for which such data are available. (v) Study Not later than 3 years after the date of enactment of this title, the Comptroller General shall conduct a study to determine whether the data utilized for purposes of clause (ii) provide the most precise measure of local area need related to substance use and addiction prevalence in local areas and whether additional data would provide more precise measures of substance use and addiction prevalence in local areas. Such study shall identify barriers to collecting or analyzing such data, and make recommendations for revising the distribution factors used under such clause to determine funding levels in order to direct funds to the local areas in most need of funding to provide substance use disorder treatment services. (vi) Reductions in amounts If a local area that is an eligible local area for a year loses such eligibility in a subsequent year based on the failure to meet the requirements of paragraph (1)(A) or (6) of section 3401(b), such area will remain eligible to receive— (I) for such subsequent year, an amount equal to 80 percent of the amount received under the grant in the previous year; and (II) for the second such subsequent year, an amount equal to 50 percent of the amount received in the previous year. (2) Supplemental grants (A) In general The Secretary shall disburse the remainder of amounts not disbursed under paragraph (1) for such fiscal year for the purpose of making grants to cities and counties whose application under section 3404— (i) contains a report concerning the dissemination of emergency relief funds under paragraph (1) and the plan for utilization of such funds, if applicable; (ii) demonstrates the need in such local area, on an objective and quantified basis, for supplemental financial assistance to combat substance use disorder; (iii) demonstrates the existing commitment of local resources of the area, both financial and in-kind, to preventing, treating, and managing substance use disorder and supporting sustained recovery; (iv) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective; (v) demonstrates that resources will be allocated in accordance with the local demographic incidence of substance use disorders and drug overdose mortality; (vi) demonstrates the inclusiveness of affected communities and individuals with substance use disorders, including those communities and individuals that are disproportionately affected or historically underserved; (vii) demonstrates the manner in which the proposed services are consistent with the local needs assessment and the State plan approved by the Secretary pursuant to section 1932(b); (viii) demonstrates success in identifying individuals with substance use disorders; and (ix) demonstrates that support for substance use disorder prevention and treatment services is organized to maximize the value to the population to be served with an appropriate mix of substance use disorder prevention and treatment services and attention to transition in care. (B) Amount (i) In general The amount of each grant made for purposes of this paragraph shall be determined by the Secretary. In making such determination, the Secretary shall consider— (I) the rate of drug overdose deaths per 100,000 population in the eligible local area; and (II) the increasing need for substance use disorder treatment services, including relative rates of increase in the number of drug overdoses or drug overdose deaths, or recent increases in drug overdoses or drug overdose deaths since data were provided under section 3401(b), if applicable. (ii) Demonstrated need The factors considered by the Secretary in determining whether a local area has a demonstrated need for purposes of clause (i)(II) may include any or all of the following: (I) The unmet need for substance use disorder treatment services, including factors identified in subparagraph (B)(i)(II). (II) Relative rates of increase in the number of drug overdoses or drug overdose deaths. (III) The relative rates of increase in the number of drug overdoses or drug overdose deaths within new or emerging subpopulations. (IV) The current prevalence of substance use disorders. (V) Relevant factors related to the cost and complexity of delivering substance use disorder treatment services to individuals in the eligible local area. (VI) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary. (VII) The prevalence of homelessness among individuals with substance use disorders. (VIII) The relevant factors that limit access to health care, including geographic variation, adequacy of health insurance coverage, and language barriers. (IX) The impact of a decline in the amount received pursuant to paragraph (1) on substance use disorder treatment services available to all individuals with substance use disorders identified and eligible under this subtitle. (X) The increasing incidence in conditions related to substance use, including hepatitis C, human immunodeficiency virus, hepatitis B and other infections associated with injection drug use. (C) Application of provisions A local area that receives a grant under this paragraph— (i) shall use amounts received in accordance with subsection (b); (ii) shall not have to meet the eligible criteria in section 3401(b); and (iii) shall not have to establish a planning council under section 3402. (3) Amount of grant to tribal governments (A) Indian tribes In this section, the term Indian tribe has the meaning given such term in section 4 of the Indian Self-Determination and Education Assistance Act. (B) Formula funds The Secretary, acting through the Indian Health Service, shall use 10 percent of the amount available under section 3406 for each fiscal year to provide formula funds to Indian tribes disproportionately affected by substance use, in an amount determined pursuant to a formula and eligibility criteria developed by the Secretary in consultation with Indian tribes, for the purposes of addressing substance use. (C) Payment of funds At the option of an Indian tribe the Secretary shall pay funds under this section through a contract, cooperative agreement, or compact under, as applicable, title I or V of the Indian Self-Determination and Education Assistance Act. (D) Use of amounts Notwithstanding any requirements in this section, an Indian tribe may use amounts provided under funds awarded under this paragraph for the uses identified in subsection (b) and any other activities determined appropriate by the Secretary, in consultation with Indian tribes. An Indian tribe shall not be required to allocate funds and services in accordance with the goals, priorities, or objectives established by a planning council under section 3402. (b) Use of amounts (1) Requirements The Secretary may not make a grant under section 3401 to an eligible local area unless the chief elected official of the area agrees that— (A) the allocation of funds and services within the area under the grant will be made in accordance with the priorities established by the planning council; and (B) funds provided under this grant will be expended for— (i) prevention services described in paragraph (3); (ii) core medical services described in paragraph (4); (iii) recovery and support services described in paragraph (5); (iv) early intervention services described in paragraph (6); (v) harm reduction services described in paragraph (7); (vi) financial assistance with health insurance described in paragraph (8); and (vii) administrative expenses described in paragraph (9). (2) Direct financial assistance (A) In general An eligible local area shall use amounts received under a grant under section 3401 to provide direct financial assistance to eligible entities or providers for the purpose of providing prevention services, core medical services, recovery and support services, early intervention services, and harm reduction services. (B) Appropriate entities Direct financial assistance may be provided under subparagraph (A) to public or nonprofit entities, other eligible Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid, or other private for-profit entities if such entities are the only available provider of quality substance use disorder treatment services in the area. (C) Limitation An eligible local area (not including tribal areas) may not provide direct financial assistance to any entity or provider that provides medication for addiction treatment if that entity or provider does not also offer mental health services or psychotherapy by licensed clinicians through a referral or onsite. (D) Neutrality towards organized labor (i) In general In carrying out duties under this section, eligible local areas shall, to the extent practicable, prioritize the distribution of grant funds to grantees that have— (I) (aa) a collective bargaining agreement; or (bb) an explicit policy not to deter employees with respect to— (AA) labor organizing for the employees engaged in the covered activities; and (BB) such employees’ choice to form and join labor organizations; and (II) policies that require— (aa) the posting and maintenance of notices in the workplace to such employees of their rights under the National Labor Relations Act ( 29 U.S.C. 151 et seq. ); (bb) that such employees are, at the beginning of their employment, provided notice and information regarding the employees’ rights under such Act; and (cc) the employer to voluntarily recognize a union in cases where a majority of such workers of the employer have joined and requested representation. (ii) Limitation This subsection does not apply to Indian tribes. (3) Prevention services (A) In general For purposes of this section, the term prevention services means evidence-based services, programs, or multi-sector strategies to prevent substance use disorder (including education campaigns, community-based prevention programs, risk identification programs, opioid diversion, collection and disposal of unused opioids, services to at-risk populations, and trauma support services). (B) Limit An eligible local area may use not to exceed 20 percent of the amount of the grant under section 3401 for prevention services. An eligible local area may apply to the Secretary for a waiver of this subparagraph. (4) Core medical services For purposes of this section, the term core medical services means the following evidence-based services provided to individuals with substance use disorder or at risk for developing substance use disorder, including through the use of telemedicine or a hub and spoke model: (A) Substance use disorder treatments, as more fully described in section 3439, including assessment of disease presence, severity, and co-occurring conditions, treatment planning, clinical stabilization services, withdrawal management and detoxification, intensive inpatient treatment, intensive outpatient treatment, outpatient treatment, residential inpatient services, treatment for co-occurring mental health and substance use disorders, and all drugs approved by the Food and Drug Administration for the treatment of substance use disorder. (B) Outpatient and ambulatory health services, including those administered by Federally-qualified health centers, rural health clinics, tribal clinics and hospitals, urban Indian organizations, certified community behavioral health clinics (as described in section 223 of the Protecting Access to Medicare Act), Native Hawaiian organizations (as defined in section 11 of the Native Hawaiian Health Care Act of 1988), and comprehensive opioid recovery centers (as described in section 552 of this Act). (C) Hospice services. (D) Mental health services. (E) Opioid overdose reversal drug products procurement, distribution, and training. (F) Pharmaceutical assistance and diagnostic testing related to the management of substance use disorders and co-morbid conditions. (G) Home- and community-based health services. (H) Comprehensive Case Management and care coordination, including substance use disorder treatment adherence services. (I) Health insurance enrollment and cost-sharing assistance in accordance with paragraph (8). (J) Programs that hire, employ, train, and dispatch licensed health care professionals, mental health professionals, harm reduction providers, or community health workers to respond in lieu of law enforcement officers in emergencies and that ensure a licensed health care professional is a member of the team that responds in lieu of law enforcement officers in emergencies in which— (i) an individual calling 911, the National Suicide Hotline, or another emergency hotlines states that a person is experiencing a drug overdose or is otherwise under the influence of a legal or illegal substance; or (ii) a law enforcement officer, other first responder, or other individual identifies a person as being (or possibly being) under the influence of a legal or illegal substance. (5) Recovery and support services For purposes of this section, the term recovery and support services means services that are provided to individuals with substance use disorder, including residential recovery housing, mental health services, long term recovery services, 24/7 hotline crisis center support, medical transportation services, respite care for persons caring for individuals with substance use disorder, child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services, outreach services, peer recovery services, nutrition services, and referrals for job training and career services, housing, legal services, and child care and family services. The entities through which such services may be provided include local and tribal authorities that provide child care, housing, community development, and other recovery and support services, so long as they do not exclude individuals on the basis that such individuals receive medication for addiction treatment. (6) Early intervention services For purposes of this section, the term early intervention services means services to provide screening and connection to the appropriate level of substance use disorder and mental health treatment (including same-day connection), counseling provided to individuals who have misused substances, who have experienced an overdose, or are at risk of developing substance use disorder, the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services for substance use disorder, and rapid access to medication for addiction treatment in the setting of recent overdose. The entities through which such services may be provided include emergency rooms, fire departments and emergency medical services, detention facilities, prisons and jails, homeless shelters, health care points of entry specified by eligible local areas, Federally-qualified health centers, workforce agencies and job centers, youth development centers, tribal clinics and hospitals, urban Indian organizations, and rural health clinics. (7) Harm reduction services For purposes of this section, the term harm reduction services means services provided to individuals engaging in substance use scientifically accepted to reduce the risk of infectious disease transmission, overdose, or death, including by increasing access to health care, housing, and recovery and support services, including syringe services programs. Such term includes evidence-based services. (8) Affordable health insurance coverage An eligible local area may use amounts provided under a grant awarded under section 3401 to establish a program of financial assistance to assist eligible individuals with substance use disorder in— (A) enrolling in health insurance coverage; or (B) affording health care services, including assistance paying cost-sharing amounts, including premiums. (9) Administration and planning An eligible local area (not including tribal areas) shall not use in excess of 15 percent of amounts received under a grant under section 3401 for administration, accounting, reporting, and program oversight functions, including the development of systems to improve data collection and data sharing, in the first year of receiving the grant, and shall not use in excess of 10 percent of amounts received under a grant under section 3401 for such activities in subsequent years. (10) Incarcerated individuals Amounts received under a grant under section 3401 may be used to provide substance use disorder treatment services, including medication for addiction treatment, to individuals who are currently incarcerated or in pre-trial detention. (c) Required terms (1) Requirement of status as medicaid provider (A) Provision of service Subject to subparagraph (B), the Secretary may not make a grant under section 3401 for the provision of substance use disorder treatment services under this section in an eligible local area unless, in the case of any such service that is available pursuant to the State plan approved under title XIX of the Social Security Act for the State— (i) the political subdivision involved will provide the service directly, and the political subdivision has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (ii) the eligible local area involved— (I) will enter into agreements with public or nonprofit entities, or other Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid, under which such entities and other providers will provide the service, and such entities and other providers have entered into such a participation agreement and are qualified to receive such payments; and (II) demonstrates that it will ensure that such entities and other providers providing the service will seek payment for each such service rendered in accordance with the usual payment schedule under the State plan. (B) Waiver (i) In general In the case of an entity making an agreement pursuant to subparagraph (A)(ii) regarding the provision of substance use disorder treatment services, the requirement established in such subparagraph shall be waived by the substance use planning council for the area involved if the entity does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. A waiver under this subparagraph shall not be longer than 2 years in duration and shall not be renewed. (ii) Determination A determination by the substance use planning council of whether an entity referred to in clause (i) meets the criteria for a waiver under such clause shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public. (2) Required terms for expanding and improving care A funding agreement for a grant under this section shall— (A) ensure that funds received under the grant will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service under a State compensation program, under an insurance policy, or under any Federal or State health benefits program (except for a program administered by, or providing the services of, the Indian Health Service); and (B) ensure that all entities providing substance use disorder treatment services with assistance made available under the grant offer all drugs approved by the Food and Drug Administration for the treatment of substance use disorder for which the applicant offers treatment, in accordance with section 3435. (3) Additional required terms A funding agreement for a grant under this section is that— (A) funds received under the grant will be utilized to supplement not supplant other Federal, State, or local funds made available in the year for which the grant is awarded to provide substance use disorder treatment services to individuals with substance use disorder, including funds for each of prevention services, core medical services, recovery and support services, early intervention services, harm reduction services, mental health services, and administrative expenses; (B) political subdivisions within the eligible local area will maintain the level of expenditures by such political subdivisions for substance use disorder treatment services at a level that is at least equal to the level of such expenditures by such political subdivisions for the preceding fiscal year, including expenditures for each of prevention services, core medical services, recovery and support services, early intervention services, harm reduction services, mental health services, and administrative expenses; (C) political subdivisions within the eligible local area will not use funds received under a grant awarded under section 3401 in maintaining the level of substance use disorder treatment services as required in subparagraph (B); (D) substance use disorder treatment services provided with assistance made available under the grant will be provided without regard— (i) to the ability of the individual to pay for such services; and (ii) to the current or past health condition of the individual to be served; (E) substance use disorder treatment services will be provided in a setting that is accessible to low-income individuals with substance use disorders and to individuals with substance use disorders residing in rural areas; (F) a program of outreach will be provided to low-income individuals with substance use disorders to inform such individuals of substance use disorder treatment services and to individuals with substance use disorders residing in rural areas; (G) Indian tribes are included in planning for the use of grant funds and the Federal trust responsibility is upheld at all levels of program administration; and (H) the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law. 3404. Application (a) Application To be eligible to receive a grant under section 3401, an eligible local area shall prepare and submit to the Secretary an application in such form, and containing such information, as the Secretary shall require, including— (1) a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved by these expenditures and a demonstration that funds received from a grant under this subtitle in the prior year were expended in accordance with local priorities developed by the local planning council established under section 3402, except that the planning council requirement shall not apply with respect to areas receiving supplemental grant funds under section 3403(a)(2); (2) establishment of goals and objectives to be achieved with grant funds provided under this subtitle, including targets and milestones that are intended to be met, the activities that will be undertaken to achieve those targets, the number of individuals likely to be served by the funds sought, including demographic data on the populations to be served, and an explanation of how these goals and objectives advance the State plan approved by the Secretary pursuant to section 1932(b); (3) a demonstration that the local area will use funds in a manner that provides substance use disorder treatment services in compliance with the evidence-based standards developed in accordance with section 3435, including providing all drugs approved by the Food and Drug Administration for the treatment of substance use disorder; (4) a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use, including allocations for services for children, youths, and women; (5) an explanation of how income, asset, and medical expense criteria will be established and applied to those who qualify for assistance under the program; (6) where practical, an explanation of how an eligible local area shall coordinate with local public health departments in the distribution of funding; and (7) for any prior funding received under this section, data provided in such form as the Secretary shall require detailing, at a minimum, the extent to which the activities supported by the funding met the goals and objectives specified in the application for the funding, the number of individuals who accessed medication for treatment by age, gender, sexual orientation, race, disability status, and other demographic criteria relevant to the program, and the effect of the program on overdose rates and rates of death due to overdose in the local area served by the program. (b) Requirements regarding imposition of charges for services (1) In general The Secretary may not make a grant under section 3401 to an eligible local area unless the eligible local area provides assurances that in the provision of substance use disorder treatment services with assistance provided under the grant— (A) in the case of individuals with an income less than or equal to 150 percent of the official poverty level, the provider will not impose charges on any such individual for the services provided under the grant; (B) in the case of individuals with an income greater than 150 percent of the official poverty level, the provider will impose a charge on each such individual according to a schedule of charges made available to the public; (C) in the case of individuals with an income greater than 150 percent of the official poverty level but not exceeding 200 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 2 percent of the annual gross income of the individual; (D) in the case of individuals with an income greater than 200 percent of the official poverty level but not exceeding 250 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 4 percent of the annual gross income of the individual involved; (E) in the case of individuals with an income greater than 250 percent of the official poverty level but not exceeding 300 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 6 percent of the annual gross income of the individual involved; (F) in the case of individuals with an income greater than 300 percent of the official poverty level but not exceeding 400 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 8.5 percent of the annual gross income of the individual involved; (G) in the case of individuals with an income greater than 400 percent of the official poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 8.5 percent of the annual gross income of the individual involved; and (H) in the case of eligible American Indian and Alaska Native individuals as defined by section 447.50 of title 42, Code of Federal Regulations (as in effect on July 1, 2010), the provider will not impose any charges for substance use disorder treatment services, including any charges or cost-sharing prohibited by section 1402(d) of the Patient Protection and Affordable Care Act. (2) Charges With respect to compliance with the assurances made under paragraph (1), an eligible local area may, in the case of individuals subject to a charge— (A) assess the amount of the charge in the discretion of the area, including imposing only a nominal charge for the provision of substance use disorder treatment services, subject to the provisions of the paragraph regarding public schedules and regarding limitations on the maximum amount of charges; and (B) take into consideration the total medical expenses of individuals in assessing the amount of the charge, subject to such provisions. (3) Aggregate charges The Secretary may not make a grant under section 3401 to an eligible local area unless the area agrees that the limitations on charges for substance use disorder treatment services under this subsection applies to the annual aggregate of charges imposed for such services, however the charges are characterized, includes enrollment fees, premiums, deductibles, cost sharing, co-payments, co-insurance costs, or any other charges. (c) Indian tribes Any application requirements for grants distributed in accordance with section 3403(a)(3) shall be developed by the Secretary in consultation with Indian tribes. 3405. Technical assistance The Secretary shall, beginning on the date of enactment of this title, provide technical assistance, including assistance from other grantees, contractors or subcontractors under this title to assist newly eligible local areas in the establishment of planning councils and, to assist entities in complying with the requirements of this subtitle in order to make such areas eligible to receive a grant under this subtitle. The Secretary may make planning grants available to eligible local areas, in an amount not to exceed $75,000, for any area that is projected to be eligible for funding under section 3401 in the following fiscal year. Such grant amounts shall be deducted from the first year formula award to eligible local areas accepting such grants. 3406. Authorization of appropriations There is authorized to be appropriated to carry out this subtitle— (1) $3,300,000,000 for fiscal year 2022; (2) $3,300,000,000 for fiscal year 2023; (3) $3,300,000,000 for fiscal year 2024; (4) $3,300,000,000 for fiscal year 2025; (5) $3,300,000,000 for fiscal year 2026; (6) $3,300,000,000 for fiscal year 2027; (7) $3,300,000,000 for fiscal year 2028; (8) $3,300,000,000 for fiscal year 2029; (9) $3,300,000,000 for fiscal year 2030; and (10) $3,300,000,000 for fiscal year 2031. B State and tribal substance use disorder prevention and intervention grant program 3411. Establishment of program of grants The Secretary shall award grants to States, territories, and tribal governments for the purpose of addressing substance use within such States. 3412. Amount of grant, use of amounts, and funding agreement (a) Amount of grant to States and territories (1) In general (A) Expedited distribution Not later than 90 days after an appropriation becomes available, the Secretary shall disburse 50 percent of the amount made available under section 3415 for carrying out this subtitle for such fiscal year through grants to States under section 3411, in accordance with subparagraphs (B) and (C). (B) Minimum allotment Subject to the amount made available under section 3415, the amount of a grant under section 3411 for— (i) each of the 50 States, the District of Columbia, and Puerto Rico for a fiscal year shall be the greater of— (I) $2,000,000; or (II) an amount determined under the subparagraph (C); and (ii) each territory other than Puerto Rico for a fiscal year shall be the greater of— (I) $500,000; or (II) an amount determined under the subparagraph (C). (C) Determination (i) Formula For purposes of subparagraph (B), the amount referred to in this subparagraph for a State (including a territory) for a fiscal year is— (I) an amount equal to the amount made available under section 3415 for the fiscal year involved for grants pursuant to subparagraph (B); and (II) the percentage constituted by the sum of— (aa) the product of 0.85 and the ratio of the State distribution factor for the State or territory to the sum of the respective distribution factors for all States; and (bb) the product of 0.15 and the ratio of the non-local distribution factor for the State or territory (as determined under clause (iv)) to the sum of the respective non-local distribution factors for all States or territories. (ii) State distribution factor For purposes of clause (i)(II)(aa), the term State distribution factor means an amount equal to— (I) the estimated number of drug overdose deaths in the State, as determined under clause (iii); or (II) the number of non-fatal drug overdoses in the State, as determined under clause (iv), as determined by the Secretary based on which distribution factor (subclause (I) or (II)) will result in the State receiving the greatest amount of funds. (iii) Number of drug overdoses For purposes of clause (ii), the number of drug overdose deaths determined under this clause for a State for a fiscal year is the number of drug overdose deaths during the most recent 3-year period for which such data are available. (iv) Number of non-fatal drug overdoses The number of non-fatal drug overdose deaths determined under this clause for a State for a fiscal year for purposes of clause (ii) may be determined by using data including emergency department syndromic data, visits, other emergency medical services for drug-related causes, or Overdose Detection Mapping Application Program (ODMAP) data during the most recent 3-year period for which such data are available. (v) Non-local distribution factors For purposes of clause (i)(II)(bb), the term non-local distribution factor means an amount equal to the sum of— (I) the number of drug overdose deaths in the State involved, as determined under clause (iii), or the number of non-fatal drug overdoses in the State, based on the criteria used by the State under clause (ii); less (II) the total number of drug overdose deaths or non-fatal drug overdoses that are within areas in such State or territory that are eligible counties under section 3401. (vi) Study Not later than 3 years after the date of enactment of this title, the Comptroller General shall conduct a study to determine whether the data utilized for purposes of clause (ii) provide the most precise measure of State need related to substance use and addiction prevalence and whether additional data would provide more precise measures the levels of substance use and addiction prevalent in States. Such study shall identify barriers to collecting or analyzing such data, and make recommendations for revising the distribution factors used under such clause to determine funding levels in order to direct funds to the States in most need of funding to provide substance use disorder treatment services. (2) Supplemental grants (A) In general Subject to subparagraph (C), the Secretary shall disburse the remainder of amounts not disbursed under paragraph (1) for such fiscal year for the purpose of making grants to States whose application— (i) contains a report concerning the dissemination of emergency relief funds under paragraph (1) and the plan for utilization of such funds, if applicable; (ii) demonstrates the need in such State, on an objective and quantified basis, for supplemental financial assistance to combat substance use disorder; (iii) demonstrates the existing commitment of local resources of the State, both financial and in-kind, to preventing, treating, and managing substance use disorder and supporting sustained recovery; (iv) demonstrates the ability of the State to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective; (v) demonstrates that resources will be allocated in accordance with the local demographic incidence of substances use disorders and drug overdose mortality; (vi) demonstrates the inclusiveness of affected communities and individuals with substance use disorders, including those communities and individuals that are disproportionately affected or historically underserved; (vii) demonstrates the manner in which the proposed services are consistent with the local needs assessment and the State plan approved by the Secretary pursuant to section 1932(b); (viii) demonstrates success in identifying individuals with substance use disorders; and (ix) demonstrates that support for substance use disorder prevention and treatment services is organized to maximize the value to the population to be served with an appropriate mix of substance use disorder treatment services and attention to transition in care. (B) Amount (i) In general The amount of each grant made for purposes of this paragraph shall be determined by the Secretary. In making such determination, the Secretary shall consider— (I) the rate of drug overdose deaths per 100,000 population in the State; and (II) the increasing need for substance use disorder treatment services, including relative rates of increase in the number of drug overdoses or drug overdose deaths, or recent increases in drug overdoses or drug overdose deaths since the data were reported under section 3413, if applicable. (ii) Demonstrated need The factors considered by the Secretary in determining whether a State has a demonstrated need for purposes of subparagraph (A)(ii) may include any or all of the following: (I) The unmet need for such services, including the factors identified in clause (i)(II). (II) Relative rates of increase in the number of drug overdoses or drug overdose deaths. (III) The relative rates of increase in the number of drug overdoses or drug overdose deaths within new or emerging subpopulations. (IV) The current prevalence of substance use disorders. (V) Relevant factors related to the cost and complexity of delivering substance use disorder treatment services to individuals in the State. (VI) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary. (VII) The prevalence of homelessness among individuals with substance use disorder. (VIII) The relevant factors that limit access to health care, including geographic variation, adequacy of health insurance coverage, and language barriers. (IX) The impact of a decline in the amount received pursuant to paragraph (1) on substance use disorder treatment services available to all individuals with substance use disorders identified and eligible under this subtitle. (X) The increasing incidence in conditions related to substance use, including hepatitis C, human immunodeficiency virus, hepatitis B and other infections associated with injection drug use. (C) Model standards (i) Preference In determining whether a State will receive funds under this paragraph, except as provided in clause (ii), the Secretary shall give preference to States that have adopted the model standards for each substance use disorder treatment service and recovery residence developed in accordance with subsections (a) and (b) of section 3435. (ii) Requirement Effective beginning in fiscal year 2024, the Secretary shall not award a grant under this paragraph to a State unless that State has adopted the model standards for each of substance use disorder treatment services and recovery residences developed in accordance with subsections (a) and (b) of section 3435. (D) Continuum of care (i) Preference In determining whether a State will receive funds under this paragraph, except as provided in clause (ii), the Secretary shall give preference to States that have carried out the requirements to ensure a continuum of services in accordance with section 3435(d). (ii) Requirement Effective beginning in fiscal year 2024, the Secretary shall not award a grant under this paragraph to a State unless that State has carried out the requirements to ensure a continuum of services in accordance with section 3435(d). (E) Utilization management for medication for addiction treatment (i) Preference In determining whether a State will receive funds under this paragraph, the Secretary shall give preference to States that have prohibited prior authorization and step therapy requirements for at least 1 drug in each class approved by the Food and Drug Administration for the treatment of substance use disorder. (ii) Additional preferences Additional preference shall be given to States that have prohibited prior authorization and step therapy requirements for 2 or more drugs in each class approved by the Food and Drug Administration for the treatment of substance use disorder. (iii) Definitions In this subparagraph: (I) Prior authorization The term prior authorization means the process by which a health insurance issuer or pharmacy benefit management company determines the medical necessity of otherwise covered health care services prior to the rendering of such health care services. Such term includes any health insurance issuer’s or utilization review entity’s requirement that a subscriber or health care provider notify the issuer or entity prior to providing a health care service. (II) Step therapy The term step therapy means a protocol or program that establishes the specific sequence in which prescription drugs for a medical condition that are medically appropriate for a particular patient are authorized by a health insurance issuer or prescription drug management company. (3) Amount of grant to tribal governments (A) Indian tribes In this section, the term Indian tribe has the meaning given such term in section 4 of the Indian Self-Determination and Education Assistance Act. (B) Formula funds The Secretary, acting through the Indian Health Service, shall use 10 percent of the amount available under section 3415 for each fiscal year to provide formula funds to Indian tribes in an amount determined pursuant to a formula and eligibility criteria developed by the Secretary in consultation with Indian tribes, for the purposes of addressing substance use. (C) Payment of funds At the option of an Indian tribe the Secretary shall pay funds under this section through a contract, cooperative agreement, or compact under, as applicable, title I or V of the Indian Self-Determination and Education Assistance Act. (D) Use of amounts Notwithstanding any requirements in this section, an Indian tribe may use amounts provided under funds awarded under this paragraph for the uses identified in subsection (b) and any other activities determined appropriate by the Secretary, in consultation with Indian tribes. (b) Use of amounts (1) In general A State or tribe may use amounts provided under grants awarded under section 3411 for— (A) prevention services described in paragraph (3); (B) core medical services described in paragraph (4); (C) recovery and support services described in paragraph (5); (D) early intervention services described in paragraph (6); (E) harm reduction services described in paragraph (7); (F) financial assistance with health insurance as described in paragraph (8); and (G) administrative expenses described in paragraph (9). (2) Direct financial assistance (A) In general A State or tribe may use amounts received under a grant under section 3411 to provide direct financial assistance to eligible entities or other eligible Medicaid providers for the purpose of providing prevention services, core medical services, recovery and support services, early intervention services, and harm reduction services. (B) Appropriate entities Direct financial assistance may be provided under subparagraph (A) to public or nonprofit entities, other Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid, or other private for-profit entities if such entities are the only available provider of quality substance use disorder treatment services in the area. (C) Limitation A State may not provide direct financial assistance to any entity or provider that provides medication for addiction treatment if that entity or provider does not also offer mental health services or psychotherapy by licensed clinicians through a referral or onsite. (D) Neutrality towards organized labor (i) In general In carrying out duties under this section, States shall, to the extent practicable, prioritize the distribution of grant funds to grantees that have— (I) (aa) a collective bargaining agreement; or (bb) an explicit policy not to deter employees with respect to— (AA) labor organizing for the employees engaged in the covered activities; and (BB) such employees’ choice to form and join labor organizations; and (II) policies that require— (aa) the posting and maintenance of notices in the workplace to such employees of their rights under the National Labor Relations Act ( 29 U.S.C. 151 et seq. ); (bb) that such employees are, at the beginning of their employment, provided notice and information regarding the employees’ rights under such Act; and (cc) the employer to voluntarily recognize a union in cases where a majority of such workers of the employer have joined and requested representation. (ii) Limitation This subsection does not apply to Indian tribes. (3) Prevention services (A) In general For purposes of this section, the term prevention services means evidence-based services, programs, or multi-sector strategies to prevent substance use disorder (including education campaigns, community-based prevention programs, risk-identification programs, opioid diversion, collection and disposal of unused opioids, services to at-risk populations, and trauma support services). (B) Limit A State may use not to exceed 20 percent of the amount of the grant under section 3411 for prevention services. A State may apply to the Secretary for a waiver of this subparagraph. (4) Core medical services For purposes of this section, the term core medical services means the following evidence-based services when provided to individuals with substance use disorder or at risk for developing substance use disorder, including through the use of telemedicine or a hub and spoke model: (A) Substance use disorder treatment, as described in section 3439(4), including assessment of disease presence, severity, and co-occurring conditions, treatment planning, clinical stabilization services, withdrawal management and detoxification, intensive inpatient treatment, intensive outpatient treatment, outpatient treatment, residential inpatient services, treatment for co-occurring mental health and substance use disorders, and all drugs approved by the Food and Drug Administration for the treatment of substance use disorder. (B) Outpatient and ambulatory health services, including those administered by Federally-qualified health centers, rural health clinics, tribal clinics and hospitals, urban Indian organizations, certified community behavioral health clinics (as described in section 223 of the Protecting Access to Medicare Act), and comprehensive opioid recovery centers (as described in section 552 of this Act). (C) Hospice services. (D) Mental health services. (E) Opioid overdose reversal drug products procurement, distribution, and training. (F) Pharmaceutical assistance related to the management of substance-use disorders and co-morbid conditions. (G) Home- and community-based health services. (H) Comprehensive Case Management and care coordination, including substance use disorder treatment adherence services. (I) Health insurance enrollment and cost-sharing assistance in accordance with paragraph (8). (J) Programs that hire, employ, train, and dispatch licensed health care professionals, mental health professionals, harm reduction providers, or community health workers to respond in lieu of law enforcement officers in emergencies and that ensure a licensed health care professional is a member of the team that responds in lieu of law enforcement officers in emergencies in which— (i) an individual calling 911, the National Suicide Hotline, or another emergency hotlines states that a person is experiencing a drug overdose or is otherwise under the influence of a legal or illegal substance; or (ii) a law enforcement officer, other first responder, or other individual identifies a person as being (or possibly being) under the influence of a legal or illegal substance. (5) Recovery and support services For purposes of this section, the term recovery and support services means services including residential recovery housing, mental health services, long term recovery services, 24/7 hotline crisis center services, medical transportation services, respite care for persons caring for individuals with substance use disorder, child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services, outreach services, peer recovery services, nutrition services, and referrals for job training and career services, housing, legal services, and child care and family services. The entities through which such services may be provided include State, local, and tribal authorities that provide child care, housing, community development, and other recovery and support services, so long as they do not exclude individuals on the basis that such individuals receive medication for addiction treatment. (6) Early intervention services For purposes of this section, the term early intervention services means services to provide screening and connection to the appropriate level of substance use disorder and mental health treatment (including same-day connection), counseling provided to individuals who have misused substances, who have experienced an overdose, or are at risk of developing substance use disorder, the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services for substance use disorder, and rapid access to medication for addiction treatment in the setting of recent overdose. The entities through which such services may be provided include emergency rooms, fire departments and emergency medical services, detention facilities, prisons and jails, homeless shelters, health care points of entry specified by eligible local areas, Federally-qualified health centers, workforce agencies and job centers, youth development centers, tribal clinics and hospitals, urban Indian organizations, and rural health clinics. (7) Harm reduction services For purposes of this section, the term harm reduction services means services provided to individuals engaging in substance use scientifically accepted to reduce the risk of infectious disease transmission, overdose, or death, including by increasing access to health care, housing, recovery, and support services, including syringe services programs. Such term includes evidence-based services. (8) Affordable health insurance coverage A State may use amounts provided under a grant awarded under section 3411 to establish a program of financial assistance to assist eligible individuals with substance use disorder in— (A) enrolling in health insurance coverage; or (B) affording health care services, including assistance paying cost-sharing amounts, including premiums. (9) Administration and planning A State shall not use in excess of 10 percent of amounts received under a grant under section 3411 for administration, accounting, reporting, and program oversight functions, including the development of systems to improve data collection and data sharing. (10) Incarcerated individuals Amounts received under a grant under section 3411 may be used to provide substance use disorder treatment services, including medication for addiction treatment, to individuals who are currently incarcerated or in pre-trial detention. (c) Required terms (1) Requirement of status as medicaid provider (A) Provision of service Subject to subparagraph (B), the Secretary may not make a grant under section 3411 for the provision of substance use disorder treatment services under this section in a State unless, in the case of any such service that is available pursuant to the State plan approved under title XIX of the Social Security Act for the State— (i) (I) the State will enter into an agreement with a political subdivision, under which the political subdivision will provide the service directly, and the political subdivision has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (II) the State will enter into agreements with public or nonprofit entities, or other Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid, under which such entities and other providers will provide the service, and such entities and other providers have entered into such a participation agreement and are qualified to receive such payments; and (III) the State ensures the political subdivision under clause (i)(I) or the public or nonprofit private entities and other providers under clause (i)(II) will seek payment for each such service rendered in accordance with the usual payment schedule under the State plan. (B) Waiver (i) In general In the case of an entity making an agreement pursuant to subparagraph (A)(ii) regarding the provision of substance use disorder treatment services, the requirement established in such subparagraph shall be waived by the State if the entity does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. A waiver under this subparagraph shall not be longer than 2 years in duration and shall not be renewed. (ii) Determination A determination by the State of whether an entity referred to in clause (i) meets the criteria for a waiver under such clause shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public. (2) Required terms for expanding and improving care A funding agreement for a grant under this section shall— (A) ensure that funds received under the grant will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service under a State compensation program, under an insurance policy, or under any Federal or State health benefits program (except for a program administered by, or providing the services of, the Indian Health Service); and (B) ensure that all entities providing substance use disorder treatment services with assistance made available under the grant shall offer all drugs approved by the Food and Drug Administration for the treatment of substance use disorder for which the applicant offers treatment, in accordance with section 3435. (3) Additional required terms A funding agreement for a grant under this section is that— (A) funds received under the grant will be utilized to supplement not supplant other Federal, State, or local funds made available in the year for which the grant is awarded to provide substance use disorder treatment services to individuals with substance use disorder, including funds for each of prevention services, core medical services, recovery and support services, early intervention services, harm reduction services, mental health services, and administrative expenses; (B) political subdivisions within the State will maintain the level of expenditures by such political subdivisions for substance use disorder treatment services at a level that is at least equal to the level of such expenditures by such political subdivisions for the preceding fiscal year including expenditures for each of prevention services, core medical services, recovery and support services, early intervention services, harm reduction services, mental health services, and administrative expenses; (C) political subdivisions within the State will not use funds received under a grant awarded under section 3411 in maintaining the level of substance use disorder treatment services as required in subparagraph (B); (D) substance use disorder treatment services provided with assistance made available under the grant will be provided without regard— (i) to the ability of the individual to pay for such services; and (ii) to the current or past health condition of the individual to be served; (E) substance use disorder treatment services will be provided in a setting that is accessible to low-income individuals with substance use disorders and to individuals with substance use disorders residing in rural areas; (F) a program of outreach will be provided to low-income individuals with substance use disorders to inform such individuals of substance use disorder treatment services and to individuals with substance use disorders residing in rural areas; (G) Indian tribes are included in planning for the use of grant funds and the Federal trust responsibility is upheld at all levels of program administration; and (H) the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law. 3413. Application (a) Application To be eligible to receive a grant under section 3411, a State shall have in effect a State plan approved by the Secretary pursuant to section 1932(b), and shall prepare and submit to the Secretary an application in such form, and containing such information, as the Secretary shall require, including— (1) a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved by these expenditures and a demonstration that funds received from a grant under this subtitle in the prior year were expended in accordance with State priorities; (2) establishment of goals and objectives to be achieved with grant funds provided under this subtitle, including targets and milestones that are intended to be met, the activities that will be undertaken to achieve those targets, and the number of individuals likely to be served by the funds sought, including demographic data on the populations to be served; (3) a demonstration that the State will use funds in a manner that provides substance use disorder treatment services in compliance with the evidence-based standards developed in accordance with section 3435, including all drugs approved by the Food and Drug Administration for the treatment of substance use disorder; (4) a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use, including allocations for services for children, youths, and women; (5) an explanation of how income, asset, and medical expense criteria will be established and applied to those who qualify for assistance under the program; and (6) for any prior funding received under this section, data provided in such form as the Secretary shall require detailing, at a minimum, the extent to which the activities supported by the funding met the goals and objectives specified in the application for the funding, the number of individuals who accessed medication for addiction treatment by age, gender, sexual orientation, race, disability status, and other demographic criteria relevant to the program, and the effect of the program on overdose rates and rates of death due to overdose in the region served by the program. (b) Requirements regarding imposition of charges for services (1) In general The Secretary may not make a grant under section 3411 to a State unless the State provides assurances that in the provision of services with assistance provided under the grant— (A) in the case of individuals with an income less than or equal to 150 percent of the official poverty level, the provider will not impose charges on any such individual for the services provided under the grant; (B) in the case of individuals with an income greater than 150 percent of the official poverty level, the provider will impose a charge on each such individual according to a schedule of charges made available to the public; (C) in the case of individuals with an income greater than 150 percent of the official poverty level but not exceeding 200 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 2 percent of the annual gross income of the individual; (D) in the case of individuals with an income greater than 200 percent of the official poverty level but not exceeding 250 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 4 percent of the annual gross income of the individual involved; (E) in the case of individuals with an income greater than 250 percent of the official poverty level but not exceeding 300 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 6 percent of the annual gross income of the individual involved; (F) in the case of individuals with an income greater than 300 percent of the official poverty level but not exceeding 400 percent of such poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 8.5 percent of the annual gross income of the individual involved; (G) in the case of individuals with an income greater than 400 percent of the official poverty level, the provider will not, for any calendar year, impose charges in an amount exceeding 8.5 percent of the annual gross income of the individual involved; and (H) in the case of eligible American Indian and Alaska Native and urban Indian individuals as defined by section 447.50 of title 42, Code of Federal Regulations (as in effect on July 1, 2010), the provider will not impose any charges for substance use disorder treatment services, including any charges or cost-sharing prohibited by section 1402(d) of the Patient Protection and Affordable Care Act. (2) Charges With respect to compliance with the assurances made under paragraph (1), a State may, in the case of individuals subject to a charge— (A) assess the amount of the charge in the discretion of the State, including imposing only a nominal charge for the provision of services, subject to the provisions of the paragraph regarding public schedules and regarding limitations on the maximum amount of charges; and (B) take into consideration the total medical expenses of individuals in assessing the amount of the charge, subject to such provisions. (3) Aggregate charges The Secretary may not make a grant under section 3411 to a State unless the State agrees that the limitations on charges for substance use disorder treatment services under this subsection applies to the annual aggregate of charges imposed for such services, however the charges are characterized, includes enrollment fees, premiums, deductibles, cost sharing, co-payments, co-insurance costs, or any other charges. (c) Indian tribes Any application requirements applying to grants distributed in accordance with section 3412(b) shall be developed by the Secretary in consultation with Indian tribes. 3414. Technical assistance The Secretary shall, directly or through grants or contracts, provide technical assistance in administering and coordinating the activities authorized under section 3412, including technical assistance for the development of State applications for supplementary grants authorized in section 3412(a)(2). 3415. Authorization of appropriations There is authorized to be appropriated to carry out this subtitle— (1) $4,600,000,000 for fiscal year 2022; (2) $4,600,000,000 for fiscal year 2023; (3) $4,600,000,000 for fiscal year 2024; (4) $4,600,000,000 for fiscal year 2025; (5) $4,600,000,000 for fiscal year 2026; (6) $4,600,000,000 for fiscal year 2027; (7) $4,600,000,000 for fiscal year 2028; (8) $4,600,000,000 for fiscal year 2029; (9) $4,600,000,000 for fiscal year 2030; and (10) $4,600,000,000 for fiscal year 2031. C Other grant program 3421. Establishment of grant program (a) Grants (1) In general The Secretary shall award grants to public entities, nonprofit entities, Indian entities, and other eligible Medicaid providers for the purpose of funding prevention services, core medical services, recovery and support services, early intervention services, harm reduction services, and administrative expenses in accordance with this section. (2) Prioritization (A) In general In awarding grants under this section, the Secretary shall, to the extent practicable, prioritize the distribution of grant funds to grantees that have— (i) an explicit policy not to deter employees with respect to— (I) labor organizing for the employees engaged in the covered activities; and (II) such employees’ choice to form and join labor organizations; or (ii) policies that require— (I) the posting and maintenance of notices in the workplace to such employees of their rights under the National Labor Relations Act ( 29 U.S.C. 151 et seq. ); (II) that such employees are, at the beginning of their employment, provided notice and information regarding the employees’ rights under such Act; and (III) the employer to voluntarily recognize a union in cases where such workers of the employer have joined and requested representation. (B) Exception This paragraph shall not apply to Indian tribes. (b) Eligibility (1) Entities Public entities, nonprofit entities, urban Indian organizations, and other Medicaid providers eligible to receive a grant under subsection (a) may include— (A) Federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act; (B) family planning clinics; (C) rural health clinics; (D) Indian entities, including Indian health programs as defined in section 4 of the Indian Health Care Improvement Act, urban Indian organizations as defined in section 4 of the Indian Health Care Improvement Act, and Native Hawaiian organizations as defined in section 11 of the Native Hawaiian Health Care Act of 1988; (E) community-based organizations, clinics, hospitals, and other health facilities that provide substance use disorder treatment services; (F) other nonprofit entities that provide substance use disorder treatment services; (G) certified community behavioral health clinics and certified community behavioral health clinic expansion grant recipients, under section 223 of the Protecting Access to Medicare Act ( 42 U.S.C. 1396a note); and (H) other Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid. (2) Underserved populations Entities described in paragraph (1) shall serve underserved populations which may include— (A) minority populations and Indian populations; (B) formerly incarcerated individuals; (C) individuals with comorbidities including human immunodeficiency virus, hepatitis B, hepatitis C, mental health disorder or other behavioral health disorders; (D) low-income populations; (E) people with disabilities; (F) urban populations; (G) rural populations; (H) the lesbian, gay, bisexual, transgender, queer (LGBTQ) community; and (I) pregnant individuals with, or at risk of developing, substance use disorder and infants with neonatal abstinence syndrome. (3) Application To be eligible to receive a grant under this section, public entities, nonprofit entities, and other Medicaid providers described in this subsection shall prepare and submit to the Secretary an application in such form, and containing such information, as the Secretary shall require, including— (A) a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved by these expenditures; (B) a comprehensive plan for the use of the grant, including— (i) a demonstration of the extent of local need for the funds sought; (ii) a plan for providing substance use disorder treatment services that is consistent with local needs; and (iii) goals and objectives to be achieved with grant funds provided under this section, including targets and milestones that are intended to be met and a description of the activities that will be undertaken to achieve those targets; (C) a demonstration that the grantee will use funds in a manner that provides substance use disorder treatment services compliant with the evidence-based standards developed in accordance with section 3435, including all drugs approved by the Food and Drug Administration for the treatment of substance use disorder for which the applicant offers treatment, in accordance with section 3435(c); (D) information on the number of individuals to be served by the funds sought, including demographic data on the populations to be served; (E) a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use, including allocations for services for children, youths, and women; (F) an explanation of how income, asset, and medical expense criteria will be established and applied to those who qualify for assistance under the program; and (G) for any prior funding received under this section, data provided in such form as the Secretary shall require detailing, at a minimum, the extent to which the activities supported by the funding met the goals and objectives specified in the application for the funding, the number of individuals who accessed medication for addiction treatment by age, gender, race, sexual orientation, disability status, and other demographic criteria relevant to the program, and the effect of the program on overdose rates and rates of death due to overdose in the region served by the program. (4) Requirement of status as medicaid provider (A) Provision of service Subject to subparagraph (B), the Secretary may not make a grant under this section for the provision of substance use disorder treatment services under this section in a State unless, in the case of any such service that is available pursuant to the State plan approved under title XIX of the Social Security Act for the State— (i) (I) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (II) the applicant for the grant will enter into an agreement with public or nonprofit entities, Indian entities, or other Medicaid providers if more than half of their patients are diagnosed with a substance use disorder and covered by Medicaid, under which such entities and other providers will provide the substance use disorder treatment service, and such entities and other providers have entered into such a participation agreement and are qualified to receive such payments; and (ii) the applicant ensures that payment will be sought for each such service rendered in accordance with the usual payment schedule under the State plan. (B) Waiver In the case of an entity making an agreement pursuant to subparagraph (A) regarding the provision of substance use disorder treatment services, the requirement established in such paragraph shall be waived by the State if the entity does not, in providing such services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. A waiver under this subparagraph shall not be longer than 2 years in duration and shall not be renewed. (C) Determination A determination by the State of whether an entity referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public. (5) Required terms for expanding and improving care A funding agreement for a grant under this section is that— (A) funds received under the grant will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service under a State compensation program, under an insurance policy, or under any Federal or State health benefits program (except for a program administered by, or providing the services of, the Indian Health Service); (B) entities providing substance use disorder treatment services with assistance made available under the grant shall offer all drugs approved by the Food and Drug Administration for the treatment of substance use disorder for which the applicant offers treatment, in accordance with section 3435(c); (C) substance use disorder treatment services provided with assistance made available under the grant will be provided without regard— (i) to the ability of the individual to pay for such services; and (ii) to the current or past health condition of the individual to be served; (D) substance use disorder treatment services will be provided in a setting that is accessible to low-income individuals with substance use disorders and to individuals with substance use disorders residing in rural areas; and (E) the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law. (c) Amount of grant to Indian entities (1) Indian Tribes In this section, the term Indian Tribe has the meaning given such term in section 4 of the Indian Self-Determination and Education Assistance Act. (2) Formula grants The Secretary, acting through the Indian Health Service, shall use 10 percent of the amount available under section 3425 for each fiscal year to provide grants to Indian entities in an amount determined pursuant to criteria developed by the Secretary in consultation with Indian Tribes and after conferring with urban Indian organizations, for the purposes of addressing substance use. (3) Use of amounts Notwithstanding any requirements in this section, Native entities may use amounts provided under grants awarded under this section for the uses identified in section 3422 and any other activities determined appropriate by the Secretary, in consultation with Indian Tribes. 3422. Use of amounts (a) Use of funds An entity shall use amounts received under a grant under section 3421 to provide direct financial assistance to eligible entities for the purpose of delivering or enhancing— (1) prevention services described in subsection (b); (2) core medical services described in subsection (c); (3) recovery and support services described in subsection (d); (4) early intervention and engagement services described in subsection (e); (5) harm reduction services described in subsection (f); and (6) administrative expenses described in subsection (g). (b) Prevention services For purposes of this section, the term prevention services means evidence-based services, programs, or multi-sector strategies to prevent substance use disorder (including education campaigns, community-based prevention programs, risk identification programs, opioid diversion, collection and disposal of unused opioids, services to at-risk populations, and trauma support services). (c) Core medical services For purposes of this section, the term core medical services means the following evidence-based services provided to individuals with substance use disorder or at risk for developing substance use disorder, including through the use of telemedicine or a hub and spoke model: (1) Substance use disorder treatment, as more fully described in section 3439(4), including assessment of disease presence, severity, and co-occurring conditions, treatment planning, clinical stabilization services, withdrawal management and detoxification, intensive inpatient treatment, intensive outpatient treatment, outpatient treatment, residential inpatient services, treatment for co-occurring mental health and substance use disorders, and all drugs approved by the Food and Drug Administration for the treatment of substance use disorder. (2) Outpatient and ambulatory health services, including those administered by Federally-qualified health centers, rural health clinics, tribal clinics and hospitals, urban Indian organizations, certified community behavioral health clinics (as described in section 223 of the Protecting Access to Medicare Act), and comprehensive opioid recovery centers (as described in section 552 of this Act). (3) Hospice services. (4) Mental health services. (5) Opioid overdose reversal drug products procurement, distribution, and training. (6) Pharmaceutical assistance related to the management of substance-use disorder and co-morbid conditions. (7) Home- and community-based health services. (8) Comprehensive Case Management and care coordination, including substance use disorder treatment adherence services. (9) Health insurance enrollment and cost-sharing assistance in accordance with section 3412. (10) Programs that hire, employ, train, and dispatch mental health professionals, harm reduction providers, or community health workers to respond in lieu of law enforcement officers in emergencies in which— (A) an individual calling 911, the National Suicide Hotline, or another emergency hotlines states that a person is experiencing a drug overdose or is otherwise under the influence of a legal or illegal substance; and (B) a law enforcement officer, other first responder, or other individual identifies a person as being (or possibly being) under the influence of a legal or illegal substance. (d) Recovery and support services For purposes of this section, the term recovery and support services means services that are provided to individuals with substance use disorder, including residential recovery housing, mental health services, long term recovery services, 24/7 hotline crisis center support, medical transportation services, respite care for persons caring for individuals with substance use disorder, child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services, outreach services, peer recovery services, nutrition services, and referrals for job training and career services, housing, legal services, and child care and family services. The entities through which such services may be provided include local and tribal authorities that provide child care, housing, community development, and other recovery and support services, so long as they do not exclude individuals on the basis that such individuals receive medication for addiction treatment. (e) Early intervention services For purposes of this section, the term early intervention services means services to provide screening and connection to the appropriate level of substance use disorder and mental health treatment (including same-day connection), counseling provided to individuals who have misused substances, who have experienced an overdose, or are at risk of developing substance use disorder, the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services for substance use disorder, and rapid access to medication for addiction treatment in the setting of recent overdose. The entities through which such services may be provided include emergency rooms, fire departments and emergency medical services, detention facilities, prisons and jails homeless shelters, health care points of entry specified by eligible local areas, Federally-qualified health centers, workforce agencies and job centers, youth development centers, tribal clinics and hospitals, urban Indian organizations, and rural health clinics. (f) Harm reduction services For purposes of this section, the term harm reduction services means services provided to individuals engaging in substance use that are scientifically accepted to reduce the risk of infectious disease transmission, overdose, or death, including by increasing access to health care, housing, and recovery and support services, including syringe services programs. Such term includes evidence-based services. (g) Administration and planning An entity (not including tribal entities) shall not use in excess of 10 percent of amounts received under a grant under section 3421 for administration, accounting, reporting, and program oversight functions, including for the purposes of developing systems to improve data collection and data sharing. (h) Relation to existing emergency medical services Nothing in this section shall be construed to diminish or alter the rights, privileges, remedies, or obligations of any provider or any Federal, State, or local government to provide emergency medical services. 3423. Technical assistance The Secretary may, directly or through grants or contracts, provide technical assistance to public or nonprofit entities, Indian entities, and other eligible Medicaid providers regarding the process of submitting to the Secretary applications for grants under section 3421, and may provide technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to such section. 3424. Planning and development grants (a) In general The Secretary may provide planning grants to public or nonprofit entities, Indian entities, and other eligible Medicaid providers for purposes of assisting such entities and providers in expanding their capacity to provide substance use disorder treatment services in low-income communities and affected subpopulations that are underserviced with respect to such services. (b) Amount A grant under this section may be made in an amount not to exceed $150,000. 3425. Authorization of appropriations There is authorized to be appropriated to carry out this subtitle— (1) $1,000,000,000 for fiscal year 2022; (2) $1,000,000,000 for fiscal year 2023; (3) $1,000,000,000 for fiscal year 2024; (4) $1,000,000,000 for fiscal year 2025; (5) $1,000,000,000 for fiscal year 2026; (6) $1,000,000,000 for fiscal year 2027; (7) $1,000,000,000 for fiscal year 2028; (8) $1,000,000,000 for fiscal year 2029; (9) $1,000,000,000 for fiscal year 2030; and (10) $1,000,000,000 for fiscal year 2031. D Innovation, training, and health systems strengthening 3431. Special projects of national significance (a) In general The Secretary shall award grants to entities to administer special projects of national significance to support the development of innovative and original models for the delivery of substance use disorder treatment and harm reduction services. (b) Grants The Secretary shall award grants under a project under subsection (a) to entities eligible for grants under subtitles A, B, and C based on newly emerging needs of individuals receiving assistance under this title. (c) Replication The Secretary shall make information concerning successful models or programs developed under this section available to grantees under this title for the purpose of coordination, replication, and integration. To facilitate efforts under this section, the Secretary may provide for peer-based technical assistance for grantees funded under this section. (d) Grants to tribal governments (1) Indian tribes In this section, the term Indian tribe has the meaning given such term in section 4 of the Indian Self-Determination and Education Assistance Act. (2) Use of funds The Secretary, acting through the Indian Health Service, shall use 10 percent of the amount available under this section for each fiscal year to provide grants to Indian tribes for the purposes of supporting the development of innovative and original models for the delivery of substance use disorder treatment services, including the development of culturally informed care models. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $500,000,000 for fiscal year 2022; (2) $500,000,000 for fiscal year 2023; (3) $500,000,000 for fiscal year 2024; (4) $500,000,000 for fiscal year 2025; (5) $500,000,000 for fiscal year 2026; (6) $500,000,000 for fiscal year 2027; (7) $500,000,000 for fiscal year 2028; (8) $500,000,000 for fiscal year 2029; (9) $500,000,000 for fiscal year 2030; and (10) $500,000,000 for fiscal year 2031. 3432. Education and training centers (a) In general The Secretary may make grants and enter into contracts to assist public or nonprofit entities, public or nonprofit schools, and academic health centers in meeting the cost of projects— (1) to train health professionals, including practitioners in programs under this title and other community providers, including physician addiction specialists, psychologists, counselors, case managers, social workers, peer recovery coaches, harm reduction workers, public health workers, and community health workers, and paraprofessionals, such as peer support specialists and recovery coaches, in the diagnosis, treatment, and prevention of substance use disorders and drug use-related health issues, including measures for the prevention and treatment of co-occurring infectious diseases, mental health disorders, and other conditions, and including (as applicable to the type of health professional involved), care for women, pregnant women, and children; (2) to train the faculty of schools of medicine, nursing, public health, osteopathic medicine, dentistry, allied health, social work, and mental health practice to teach health professions students to screen for and provide for the needs of individuals with substance use disorders or at risk of substance use; and (3) to develop and disseminate curricula and resource materials relating to evidence-based practices for the screening, prevention, and treatment of substance use disorders and drug use-related health issues, including information about combating stigma, prescribing best practices, overdose reversal, alternative pain therapies, and all drugs approved by the Food and Drug Administration for the treatment of substance use disorders, including for the purposes authorized under the amendments made by section 3203 of the SUPPORT for Patients and Communities Act. (b) Preference in making grants In making grants under subsection (a), the Secretary shall give preference to qualified projects that will— (1) train, or result in the training of, health professionals and other community providers described in subsection (a)(1), to provide substance use disorder treatments for underserved groups, including minority individuals and Indians with substance use disorder and other individuals who are at a high risk of substance use; (2) train, or result in the training of, minority health professionals and minority allied health professionals, to provide substance use disorder treatment for individuals with such disease; (3) train or result in the training of individuals who will provide substance use disorder treatment in rural or other areas that are underserved by current treatment structures; (4) train or result in the training of health professionals and allied health professionals, including counselors, case managers, social workers, peer recovery coaches, and harm reduction workers, public health workers, and community health workers, to provide treatment for infectious diseases and mental health disorders co-occurring with substance use disorder; and (5) train or result in the training of health professionals and other community providers to provide substance use disorder treatments for pregnant women, children, and adolescents. (c) Native education and training centers The Secretary shall use 10 percent of the amount available under subsection (d) for each fiscal year to provide grants authorized under this subtitle to— (1) tribal colleges and universities; (2) Indian Health Service grant funded institutions; and (3) Native partner institutions, including institutions of higher education with medical training programs that partner with one or more Indian tribes, tribal organizations, Native Hawaiian organizations, or tribal colleges and universities to train Native health professionals that will provide substance use disorder treatment services in Native communities. (d) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $500,000,000 for fiscal year 2022; (2) $500,000,000 for fiscal year 2023; (3) $500,000,000 for fiscal year 2024; (4) $500,000,000 for fiscal year 2025; (5) $500,000,000 for fiscal year 2026; (6) $500,000,000 for fiscal year 2027; (7) $500,000,000 for fiscal year 2028; (8) $500,000,000 for fiscal year 2029; (9) $500,000,000 for fiscal year 2030; and (10) $500,000,000 for fiscal year 2031. 3433. Substance use disorder treatment provider capacity under the Medicaid program (a) Projects (1) In general The Secretary shall use amounts appropriated under this section to provide funding for projects in any State or territory to increase substance use provider capacity, as provided for in section 1903(aa) of the Social Security Act. (2) Prioritizations (A) In general In awarding grants under this section, the Secretary shall, to the extent practicable, prioritize the distribution of grant funds to grantees that have— (i) an explicit policy not to deter employees with respect to— (I) labor organizing for the employees engaged in the covered activities; and (II) such employees’ choice to form and join labor organizations; and (ii) policies that require— (I) the posting and maintenance of notices in the workplace to such employees of their rights under the National Labor Relations Act ( 29 U.S.C. 151 et seq. ); (II) that such employees are, at the beginning of their employment, provided notice and information regarding the employees’ rights under such Act; and (III) the employer to voluntarily recognize a union in cases where such workers of the employer have joined and requested representation. (B) Exception This paragraph shall not apply to Indian tribes. (b) Amount of grant to Indian entities (1) Indian tribes In this section, the term Indian tribe has the meaning given such term in section 4 of the Indian Self-Determination and Education Assistance Act. (2) Urban indian organization In this section, the term urban Indian organization has the meaning given such in section 4 of the Indian Health Care Improvement Act. (3) Grants The Secretary, acting through the Indian Health Service, shall use 10 percent of the amount appropriated under this section for each fiscal year to award grants to Indian tribes and urban Indian organizations in an amount determined pursuant to criteria developed by the Secretary in consultation with Indian tribes and in conference with urban Indian organizations. (c) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $50,000,000 for fiscal year 2022; (2) $50,000,000 for fiscal year 2023; (3) $50,000,000 for fiscal year 2024; (4) $50,000,000 for fiscal year 2025; (5) $50,000,000 for fiscal year 2026; (6) $50,000,000 for fiscal year 2027; (7) $50,000,000 for fiscal year 2028; (8) $50,000,000 for fiscal year 2029; (9) $50,000,000 for fiscal year 2030; and (10) $50,000,000 for fiscal year 2031. 3434. Programs to support employees (a) Grant program for workers (1) In general The Secretary, acting through the Director of the National Institute for Occupational Safety and Health, shall award grants to non-profit entities that meet the requirements of this section to fund programs and projects to assist workers who are at risk of substance use disorder, who have substance use disorder, or who are recovering from substance use disorder to maintain or gain employment. (2) Grants for workers (A) In general The Secretary shall, on a competitive basis, award grants for a period of not more than 3 years to non-profit entities that submit an application under paragraph (3) to enable such entities to implement, conduct, continue, and expand evidence-based programs and projects to assist individuals described in subparagraph (G). (B) Use of amounts An entity may use amounts provided under this subsection for— (i) prevention services described in subparagraph (C), including providing education and information to workers regarding the dangers of illicit and licit drug use, non-opioid pain management and non-drug pain management, or occupational injury and illness prevention; (ii) early intervention services described in subparagraph (D) to enable individuals to maintain or gain employment; (iii) recovery and support services described in subparagraph (E) to enable individuals to maintain or gain employment; (iv) harm reduction services described in subparagraph (F) to enable individuals to maintain or gain employment; (v) hiring case managers, care coordinators, and peer support specialists to assist employed individuals who are experiencing substance use disorder, or who are recovering from substance use disorder, in accessing substance use disorder treatment services; or (vi) providing vocational, life skills, and other forms of job training to workers who are receiving substance use disorder treatment services to enable such workers to maintain or gain employment. (C) Prevention services For purposes of this section, the term prevention services means evidence-based services, programs, or multi-sector strategies to prevent substance use disorder (including education campaigns, community-based prevention programs, risk identification programs, opioid diversion, collection and disposal of unused opioids, services to at-risk populations, and trauma support services). (D) Recovery and support services For purposes of this section, the term recovery and support services means services including residential recovery housing, mental health services, long term recovery services, 24/7 hotline crisis center services, medical transportation services, respite care for persons caring for individuals with substance use disorder, child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services, outreach services, peer recovery services, nutrition services, and referrals for job training and career services, housing, legal services, and child care and family services so long as they do not exclude individuals on the basis that such individuals receive medication for addiction treatment. (E) Early intervention services For purposes of this section, the term early intervention services means services to provide screening and connection to the appropriate level of substance use disorder and mental health treatment (including same-day connection), counseling provided to individuals who have misused substances, who have experienced an overdose, or are at risk of developing substance use disorder, the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services for substance use disorder, and rapid access to medication for addiction treatment in the setting of recent overdose. (F) Harm reduction services For purposes of this section, the term harm reduction services means services provided to individuals engaging in substance use scientifically accepted to reduce the risk of infectious disease transmission, overdose, or death, including by increasing access to health care, housing, and recovery and support services, including syringe services programs. Such term includes evidence-based services. (G) Individuals described Individuals described in this subparagraph are individuals who— (i) (I) have been employed in the 12-month period immediately preceding the date on which the determination is being made, or who are participating in an employee training or apprenticeship program; and (II) are at high risk of developing substance use disorder, including as a result of employment in industries that experience high rates of occupational injuries and illness; or (ii) are experiencing a substance use disorder or are in recovery from a substance use disorder. (3) Applications To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including— (A) a complete accounting of the disbursement of any prior grants received under this title by the applicant and the results achieved by such expenditures; (B) a description of the population to be served with grant funds provided under this section, including a description of the unique risks the population faces for experiencing occupational injuries or exposure to illicit substances; (C) the goals and objectives to be achieved with grant funds provided under this section, including targets and milestones that are intended to be met, the activities that will be undertaken to achieve those targets, and the number of individuals likely to be served by the grant funds, including demographic data on the populations to be served; (D) a demonstration of the ability of the applicant to reach the individuals described in paragraph (2)(G) and to provide services described in paragraph (2)(B) included in the applicant’s grant application, including by partnering with local stakeholders; (E) for any prior funding received under this subsection, data provided in such form as the Secretary shall require detailing, at a minimum, the extent to which the activities supported by the funding met the goals, objectives, targets, and milestones specified in the application for the funding, and the number of individuals with and without substance use disorder who received services supported by the funding, including the services provided to these individuals, the industries in which the individuals were employed when they received services, and whether the individuals were still employed in that same industry or in any industry when the individuals ceased receiving services supported by the funding; and (F) any other information the Secretary shall require. (4) Data reporting and oversight An entity awarded a grant under this subsection shall submit to the Secretary an annual report at such time and in such manner as the Secretary shall require. Such report shall include, at a minimum, a description of— (A) the activities funded by the grant; (B) the number of individuals with and without substance use disorder served through activities funded by the grant, including the services provided to those individuals and the industries in which those individuals were employed at the time they received services supported by the grant; (C) for workers experiencing substance use disorder or recovering from substance use disorder served by activities funded by the grant, the number of individuals who maintained employment, the number of individuals who gained employment, and the number of individuals who failed to maintain employment over the course of the reporting period; and (D) any other information required by the Secretary. (5) Authorization of appropriations There is authorized to be appropriated to carry out this subsection— (A) $40,000,000 for fiscal year 2022; (B) $40,000,000 for fiscal year 2023; (C) $40,000,000 for fiscal year 2024; (D) $40,000,000 for fiscal year 2025; (E) $40,000,000 for fiscal year 2026; (F) $40,000,000 for fiscal year 2027; (G) $40,000,000 for fiscal year 2028; (H) $40,000,000 for fiscal year 2029; (I) $40,000,000 for fiscal year 2030; and (J) $40,000,000 for fiscal year 2031. (b) Research on the impact of substance use disorder in the workplace and on direct service providers (1) Risks of substance use disorder The Secretary, in consultation with the Director of the National Institute for Occupational Safety and Health, shall conduct (directly or through grants or contracts) research, experiments, and demonstrations, and publish studies relating to— (A) the risks faced by employees in various occupations of developing substance use disorder and of drug overdose deaths and non-fatal drug overdoses, and the formulation of prevention activities tailored to the risks identified in these occupations, including occupational injury and illness prevention; (B) the prevalence of substance use disorder among employees in various occupations; (C) efforts that employers may undertake to assist employees who are undergoing substance use disorder treatment services in maintaining employment while ensuring workplaces are safe and healthful; (D) risks of occupational exposure to opioids and other illicit substances and the formulation of prevention activities tailored to the risks identified; and (E) other subjects related to substance use disorder in the workplace as the Secretary determines. (2) Direct service providers The Secretary shall conduct (directly or through grants or contracts) research, experiments, and demonstrations, and publish studies relating to the occupational health and safety, recruitment, and retention of behavioral health providers who, as part of their job responsibilities, provide direct services to individuals who are at risk of experiencing substance use disorder or who are experiencing or recovering from substance use disorder, including— (A) identifying factors that the Secretary believes may endanger the health or safety of such workers, including factors that affect the risks such workers face of developing substance use disorder; (B) motivational and behavioral factors relating to the field of behavioral health providers; (C) strategies to support the recruitment and retention of behavioral health providers; and (D) other subjects related to behavioral health providers engaged in direct provision of substance use disorder prevention and treatment services as the Secretary determines appropriate. (3) Authorization of appropriations There is authorized to be appropriated to carry out this subsection— (A) $10,000,000 for fiscal year 2022; (B) $10,000,000 for fiscal year 2023; (C) $10,000,000 for fiscal year 2024; (D) $10,000,000 for fiscal year 2025; (E) $10,000,000 for fiscal year 2026; (F) $10,000,000 for fiscal year 2027; (G) $10,000,000 for fiscal year 2028; (H) $10,000,000 for fiscal year 2029; (I) $10,000,000 for fiscal year 2030; and (J) $10,000,000 for fiscal year 2031. 3435. Improving and expanding care (a) Level of care standards for substance use disorder treatment services (1) In general Not later than 1 year after the date of enactment of this title, the Secretary, in consultation with the American Society of Addiction Medicine, State and tribal officials selected by the Secretary, and other stakeholders as the Secretary determines necessary, and after seeking public input, shall promulgate model standards for the regulation of substance use disorder treatment services. (2) Substance use disorder treatment services The model standards promulgated under paragraph (1) shall, at a minimum— (A) identify the types of substance use disorder treatment services intended to be covered without regard to whether they participate in any Federal health care program (as defined in section 1128B(f) of the Social Security Act) and shall not include— (i) a private practitioner who is already licensed by a State licensing board and whose practice is limited to non-intensive outpatient care; or (ii) any substance use disorder treatment service provided on a non-intensive outpatient basis in the office of a private practitioner who is licensed by a State licensing board; (B) require the designation of a single State agency to serve as the primary regulator in the State for substance use disorder treatment services; (C) subject to paragraph (3), require that substance use disorder treatment services identified in accordance with subparagraph (A), be licensed by the respective States according to the standards for levels of care set forth by the American Society of Addiction Medicine in 2013 or an equivalent set of standards; (D) require implementation of a process to ensure that substance use disorder treatment program qualifications are verified by means of an onsite inspection not less frequently than every 3 years by the State agency serving as the primary regulator in the State for substance use disorder treatment services or by an independent third party that is approved by the State’s primary regulator; and (E) require that all patients leaving a residential treatment program receive a written transition plan prior to discharge from that level of care. (3) Annual assessment Beginning with respect to fiscal year 2022, the Secretary shall make a determination with respect to each State on whether the State has adopted, for each of the substance use disorder treatment services identified in accordance with paragraph (2)(A), licensure standards that are in compliance in all material respects with the model standards promulgated in accordance with this subsection. In the event the American Society of Addiction Medicine revises its criteria, the Secretary shall revise the national model level of care standards accordingly and disseminate any such update to the States, and the States may adopt any such updates to be in compliance with this subsection. (b) Standards for other specified matters related to substance use disorder treatment services and recovery residences (1) In general Not later than 2 years after the date of enactment of this title, the Secretary, in consultation with representatives of nonprofit service providers and State and tribal officials as the Secretary determines necessary, shall promulgate model standards for the regulation of— (A) other specified matters related to substance use disorder treatment services; and (B) recovery residences. (2) Other specified matters related to substance use disorder treatment services The model standards promulgated under paragraph (1)(A) shall, at a minimum— (A) identify the professional credentials needed by each type of substance use disorder treatment professional; (B) include standards for data reporting and require compilation of statewide reports; (C) require the establishment and maintenance within each State of a toll-free telephone number to receive complaints from the public regarding substance use disorder treatment service providers; and (D) require the establishment and maintenance on a publicly accessible internet website of a list of all substance use disorder treatment services in the State that have a certification in effect in accordance with this section. (3) Recovery residences (A) Economic relationship The model standards promulgated under paragraph (1)(B) shall, at a minimum, be applied to recovery residences that have an ongoing economic relationship with any commercial substance use disorder treatment service. (B) Minimum requirements The model standards promulgated under paragraph (1)(B), which may include any model laws developed under section 550(a) shall, at a minimum, identify requirements for— (i) the designation of a single State agency to certify recovery residences; (ii) the implementation of a process to ensure that the qualifications of recovery residences in which not fewer than 10 individuals may lawfully reside are verified by means of an onsite inspection not less frequently than every 3 years by the State agency serving as the primary regulator in the State or by an independent third party that is approved by the State’s primary regulator; (iii) fire, safety, and health standards; (iv) equipping residences with opioid overdose reversal drug products, such as naloxone and training residence owners, operators, and employees in the administration of naloxone; (v) recovery residence owners and operators; (vi) a written policy that prohibits the exclusion of individuals on the basis that such individuals receive drugs approved by the Food and Drug Administration for the treatment of substance use disorder; (vii) the establishment and maintenance within each State of a toll-free telephone number to receive complaints from the public regarding recovery residences; and (viii) the establishment and maintenance on a publicly accessible internet website of a list of all recovery residences in the State that have a certification in effect in accordance with this section. (4) Annual assessment Beginning with respect to fiscal year 2023, the Secretary shall make a determination with respect to each State on whether the State has adopted, for each of the other specified substance use disorder treatment services identified in this section and for recovery residences, standards that are in compliance in all material respects with the model standards promulgated in accordance with this subsection. (c) Ensuring access to medication for addiction treatment (1) Medication for addiction treatment The Secretary may not make a grant under this section unless the applicant for the grant agrees to require all entities offering substance use disorder treatment services under the grant to offer all drugs approved by the Food and Drug Administration for the treatment of substance use disorder for which the applicant offers treatment. (2) Waiver The Secretary may grant a waiver with respect to any requirement of this section if the grant applicant involved— (A) submits to the Secretary a justification for such waiver containing such information as the Secretary shall require; and (B) agrees to require all entities offering substance use disorder treatment services under the grant to— (i) offer, on site, at least 2 drugs approved by the Food and Drug Administration for the treatment of substance use disorder; (ii) provide counseling to patients on the benefits and risks of all drugs approved by the Food and Drug Administration for the treatment of substance use disorder; and (iii) maintain an affiliation agreement with a provider that can prescribe or otherwise dispense all other forms of drugs approved by the Food and Drug Administration for the treatment of substance use disorder. (3) GAO study Not later than 1 year after the date of enactment of this title, the Comptroller General of the United States shall submit to Congress a comprehensive report describing any relationship between substance use rates, pain management practices of the Indian Health Service, and patient request denials through the purchased/referred care program of the Indian Health Service. (d) Ensuring a full continuum of services (1) In general Not later than 6 months after the date of the enactment of this title, the Administrator of the Centers for Medicare & Medicaid Services shall issue a State Medicaid Director letter and tribal leader letter explaining how States and tribes can ensure access to a continuum of services for adults with substance use disorders who are receiving medical assistance under title XIX of the Social Security Act. Such letter shall describe how States can cover the continuum of community-based, residential, and inpatient substance use disorder services and care coordination between different levels of care as medical assistance, as defined in section 1905(a) of such Act, including through section 1915 of such Act and through demonstration projects under section 1115 of such Act. (2) MACPAC Analysis Not later than 1 year after the date of the enactment of this title, the Medicaid and CHIP Payment and Access Commission shall conduct an analysis, and make publicly available a report containing the results of such analysis, of States’ coverage of substance use services for Medicaid beneficiaries. Such report shall include examples of promising strategies States use to cover a continuum of community-based substance use services. (3) Annual assessment Beginning with respect to fiscal year 2022, the Secretary shall make a determination with respect to each State on whether the State has carried out the requirements to ensure a continuum of services as described in section 1915(l)(4)(C) of the Social Security Act. 3436. Naloxone distribution program (a) Establishment of program (1) In general The Secretary shall provide for the purchase and delivery of federally approved opioid overdose reversal drug products on behalf of each State (or Indian tribe as defined in section 4 of the Indian Health Care Improvement Act) that receives a grant under subtitle B. This paragraph constitutes budget authority in advance of appropriations Acts, and represents the obligation of the Federal Government to provide for the purchase and delivery to States and Indian tribes of the opioid overdose reversal drug products in accordance with this paragraph. (2) Special rules where opioid overdose reversal drug products are unavailable To the extent that a sufficient quantity of opioid overdose reversal drug products are not available for purchase or delivery under paragraph (1), the Secretary shall provide for the purchase and delivery of the available opioid overdose reversal drug products in accordance with priorities established by the Secretary, with priority given to States with at least one local area eligible for funding under section 3401(a). (b) Negotiation of contracts with manufacturers (1) In general For the purpose of carrying out this section, the Secretary shall negotiate and enter into contracts with manufacturers of opioid overdose reversal drug products consistent with the requirements of this subsection and, to the maximum extent practicable, consolidate such contracting with any other contracting activities conducted by the Secretary to purchase opioid overdose reversal drug products. The Secretary may enter into such contracts under which the Federal Government is obligated to make outlays, the budget authority for which is not provided for in advance in appropriations Acts, for the purchase and delivery of opioid overdose reversal drug products under subsection (a). (2) Authority to decline contracts The Secretary may decline to enter into contracts under this subsection and may modify or extend such contracts. (3) Contract price (A) In general The Secretary, in negotiating the prices at which opioid overdose reversal drug products will be purchased and delivered from a manufacturer under this subsection, shall take into account quantities of opioid overdose reversal drug products to be purchased by States under the option under paragraph (4)(B). (B) Negotiation of discounted price for opioid overdose reversal drug products With respect to contracts entered into for the purchase of opioid overdose reversal drug products on behalf of States under this subsection, the price for the purchase of such drug product shall be a discounted price negotiated by the Secretary. (4) Product dosage All opioid overdose reversal products purchased under this section shall contain— (A) for each dose, the maximum amount of active pharmaceutical ingredient that acts as an opioid receptor antagonist as recommended by the Food and Drug Administration as an initial dose when administered by one of the approved, labeled routes of administration in adults; and (B) a minimum of two doses packaged together. (5) Quantities and terms of delivery Under contracts under this subsection— (A) the Secretary shall provide, consistent with paragraph (6), for the purchase and delivery on behalf of States and Indian tribes of quantities of opioid overdose reversal drug products; and (B) each State and Indian tribe, at the option of the State or tribe, shall be permitted to obtain additional quantities of opioid overdose reversal drug products (subject to amounts specified to the Secretary by the State or tribe in advance of negotiations) through purchasing the opioid overdose reversal drug products from the manufacturers at the applicable price negotiated by the Secretary consistent with paragraph (3), if the State or tribe provides to the Secretary such information (at a time and manner specified by the Secretary, including in advance of negotiations under paragraph (1)) as the Secretary determines to be necessary, to provide for quantities of opioid overdose reversal drug products for the State or tribe to purchase pursuant to this subsection and to determine annually the percentage of the opioid overdose reversal drug market that is purchased pursuant to this section and this subparagraph. The Secretary shall enter into the initial negotiations not later than 180 days after the date of the enactment of this title. (6) Charges for shipping and handling The Secretary may enter into a contract referred to in paragraph (1) only if the manufacturer involved agrees to submit to the Secretary such reports as the Secretary determines to be appropriate to assure compliance with the contract and if, with respect to a State program under this section that does not provide for the direct delivery of qualified opioid overdose reversal drug products, the manufacturer involved agrees that the manufacturer will provide for the delivery of the opioid overdose reversal drug products on behalf of the State in accordance with such program and will not impose any charges for the costs of such delivery (except to the extent such costs are provided for in the price established under paragraph (3)). (7) Multiple suppliers In the case of the opioid overdose reversal drug product involved, the Secretary may, as appropriate, enter into a contract referred to in paragraph (1) with each manufacturer of the opioid overdose reversal drug product that meets the terms and conditions of the Secretary for an award of such a contract (including terms and conditions regarding safety and quality). With respect to multiple contracts entered into pursuant to this paragraph, the Secretary may have in effect different prices under each of such contracts and, with respect to a purchase by States pursuant to paragraph (4)(B), each eligible State may choose which of such contracts will be applicable to the purchase. (c) Use of opioid overdose reversal drug product list Beginning not later than one year after the first contract has been entered into under this section, the Secretary shall use, for the purpose of the purchase, delivery, and administration of opioid overdose reversal drug products under this section, the list established (and periodically reviewed and, as appropriate, revised) by an advisory committee, established by the Secretary and located within the Centers for Disease Control and Prevention, which considers the cost effectiveness of each opioid overdose reversal drug product. (d) State distribution of opioid overdose reversal drug products States shall distribute opioid overdose reversal drug products received under this section to the following: (1) First responders and local emergency medical services organizations, including volunteer emergency medical services organizations. (2) Public entities with authority to administer local public health services, including all local health departments, for the purposes of making opioid overdose reversal drug products available to— (A) nonprofit entities, including— (i) community-based organizations that provide substance use disorder treatments or harm reduction services; (ii) nonprofit entities that provide substance use disorder treatments or harm reduction services; and (iii) faith based organizations that provide substance use disorder treatments or harm reduction services; (B) other areas of high need; and (C) the general public. (e) State requirements To be eligible to receive opioid overdose reversal drugs under this section, each State shall— (1) establish a program for distributing opioid overdose reversal drug products to first responders, the general public, and entities with authority to administer local public health services, including local health departments; (2) beginning in the second year of the program, demonstrate a distribution rate of a minimum of 90 percent of the opioid overdose reversal drug products received under this program; (3) certify to the Secretary that the State has in place a Good Samaritan Law that ensures immunity from arrest and prosecution, including from parole and probation violations, except that the State may apply to the Secretary for a waiver of the requirement of this paragraph, and such waiver if granted shall not be longer than 3 years in duration and may not be renewed unless the State can show progress being made towards instituting a Good Samaritan Law; and (4) certify to the Secretary that the State has in place additional measures that enhance access to opioid overdose reversal drug products, such as laws that provide civil or disciplinary immunity for medical personnel who prescribe an opioid overdose reversal drug product, Third Party Prescription Laws, Collaborative Practice Agreements, and Standing Orders. (f) Indian tribe requirements The Indian Health Service, in consultation with Indian tribes, shall determine any requirements that shall apply to Indian tribes receiving opioid overdose reversal drug products made available under this section. (g) Definitions For purposes of this section: (1) Collaborative practice agreement The term Collaborative Practice Agreement means an agreement under which a pharmacist operates under authority delegated by another licensed practitioner with prescribing authority. (2) Emergency medical service The term emergency medical service means resources used by a public or private licensed entity to deliver medical care outside of a medical facility under emergency conditions that occur as a result of the condition of the patient and includes services delivered (either on a compensated or volunteer basis) by an emergency medical services provider or other provider that is licensed or certified by the State involved as an emergency medical technician, a paramedic, or an equivalent professional (as determined by the State). (3) Good samaritan law The term Good Samaritan Law means a law that provides criminal immunity for a person who administers an opioid overdose reversal drug product, a person who, in good faith, seeks medical assistance for someone experiencing a drug-related overdose, or a person who experiences a drug-related overdose and is in need of medical assistance and, in good faith, seeks such medical assistance, or is the subject of such a good faith request for medical assistance. (4) Indians The terms Indian , Indian tribe , tribal organization , and urban Indian organization have the meanings given such terms in section 4 of the Indian Health Care Improvement Act. (5) Manufacturer The term manufacturer means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any opioid overdose reversal drug product. The term manufacture means to manufacture, import, process, or distribute an opioid overdose reversal drug. (6) Opioid overdose reversal drug product The term opioid overdose reversal drug product means a finished dosage form that has been approved by the Food and Drug Administration and that contains an active pharmaceutical ingredient that acts as an opioid receptor antagonist. The term opioid overdose reversal drug product includes a combination product, as defined in section 3.2(e) of title 21, Code of Federal Regulations. (7) Standing order The term standing order means a non-patient-specific order covering administration of medication by others to a patient who may be unknown to the prescriber at the time of the order. (8) Third party prescription The term third party prescription means an order written for medication dispensed to one person with the intention that it will be administered to another person. (h) Authorization of appropriations There is authorized to be appropriated to carry out this suction— (1) $1,000,000,000 for fiscal year 2022; (2) $1,000,000,000 for fiscal year 2023; (3) $1,000,000,000 for fiscal year 2024; (4) $1,000,000,000 for fiscal year 2025; (5) $1,000,000,000 for fiscal year 2026; (6) $1,000,000,000 for fiscal year 2027; (7) $1,000,000,000 for fiscal year 2028; (8) $1,000,000,000 for fiscal year 2029; (9) $1,000,000,000 for fiscal year 2030; and (10) $1,000,000,000 for fiscal year 2031. 3437. Additional funding for the National Institutes of Health There is authorized to be appropriated to the National Institutes of Health for the purpose of conducting research on addiction and pain, including research to develop overdose reversal drug products, non-opioid drug products and non-pharmacological treatments for addressing pain and substance use disorder, and drug products used to treat substance use disorder— (1) $1,000,000,000 for fiscal year 2022; (2) $1,000,000,000 for fiscal year 2023; (3) $1,000,000,000 for fiscal year 2024; (4) $1,000,000,000 for fiscal year 2025; (5) $1,000,000,000 for fiscal year 2026; (6) $1,000,000,000 for fiscal year 2027; (7) $1,000,000,000 for fiscal year 2028; (8) $1,000,000,000 for fiscal year 2029; (9) $1,000,000,000 for fiscal year 2030; and (10) $1,000,000,000 for fiscal year 2031. 3438. Additional funding for the Centers for Disease Control and Prevention (a) Improved data collection and prevention of infectious disease transmission (1) Data collection The Centers for Disease Control and Prevention shall use a portion of the funding appropriated under this section to ensure that all States participate in the Enhanced State Opioid Overdose Surveillance program and to provide technical assistance to medical examiners and coroners to facilitate improved data collection on fatal overdoses through such program. (2) Centers for Disease Control and Prevention The Centers for Disease Control and Prevention shall use amounts appropriated under this section for the purpose of improving data on drug overdose deaths and non-fatal drug overdoses, surveillance related to addiction and substance use disorder, and the prevention of transmission of infectious diseases related to substance use. (3) Tribal data Not later than 6 months after the date of enactment of this title, the Director of the Centers for Disease Control and Prevention shall consult with Indian tribes and confer with urban Indian organizations to develop and implement strategies that improve surveillance and reporting of fatal overdose deaths among American Indians and Alaska Natives, including strategies that reduce the underestimation of fatal overdose deaths among American Indians and Alaska Natives due to undersampling or racial misclassification in State and Federal public health surveillance systems. (b) Childhood trauma The Centers for Disease Control and Prevention shall use a portion of the funding appropriated under this section to fund the surveillance and data collection activities described in section 7131 of the SUPPORT for Patients and Communities Act, including to encourage all States to participate in collecting and reporting 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. (c) Worker health risks The Centers for Disease Control and Prevention shall use a portion of the funding appropriated under this section for data collection and surveillance activities on substance use, substance use disorders, drug overdose deaths, and non-fatal drug overdoses among workers, and the factors and practices that contribute to such use, disorders, and overdoses, including occupational injuries and illness as well as occupational exposure to opioids and other illicit and licit drugs. (d) Tribal epidemiology centers There shall be made available to the Indian Health Service for the purpose of funding efforts by Indian tribes and tribal epidemiology centers to improve data on drug overdose deaths and non-fatal drug overdoses, surveillance related to addiction and substance use disorder, and prevention of childhood trauma, not less than 1.5 percent of the total amount appropriated under this section for each fiscal year. (e) Authorization of appropriations There is authorized to be appropriated to carry out this section— (1) $500,000,000 for fiscal year 2022; (2) $500,000,000 for fiscal year 2023; (3) $500,000,000 for fiscal year 2024; (4) $500,000,000 for fiscal year 2025; (5) $500,000,000 for fiscal year 2026; (6) $500,000,000 for fiscal year 2027; (7) $500,000,000 for fiscal year 2028; (8) $500,000,000 for fiscal year 2029; (9) $500,000,000 for fiscal year 2030; and (10) $500,000,000 for fiscal year 2031. 3439. Definitions In this title: (1) Planning council The term planning council means the substance use planning council established under section 3402. (2) Recovery residence The term recovery residence means a residential dwelling unit, or other form of group housing, that is offered or advertised through any means, including oral, written, electronic, or printed means, by any individual or entity as a residence that provides an evidence-based, peer-supported living environment for individuals undergoing any type of substance use disorder treatment or who have received any type of substance use disorder treatment in the past 3 years, including medication for addiction treatment. (3) State (A) In general The term State means each of the 50 States, the District of Columbia, and each of the territories. (B) Territories The term territory means each of American Samoa, Guam, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau. (4) Substance use disorder treatment (A) In general The term substance use disorder treatment means an evidence-based, professionally directed, deliberate, and planned regimen including evaluation, observation, medical monitoring, and rehabilitative services and interventions such as pharmacotherapy, mental health services, and individual and group counseling, on an inpatient or outpatient basis, to help patients with substance use disorder reach remission and maintain recovery. (B) Types of treatment Substance use disorder treatments shall include the following: (i) Clinical stabilization services, which are evidence-based services provided in secure, acute care facilities (which may be referred to as addictions receiving facilities ) that, at a minimum— (I) provide intoxication management and stabilization services; (II) are operated 24 hours per day, 7 days per week; and (III) that serve individuals found to be substance use impaired. These can also be referred to as Addictions receiving facilities . (ii) Withdrawal management and detoxification, which is a medical service that is provided on an inpatient or an outpatient basis to assist an individual in managing the process of withdrawal from the physiological and psychological effects of substance use disorder. (iii) All outpatient, residential, and inpatient services described in section 1915(l)(4)(c) of the Social Security Act. (C) Limitation Substance use disorder treatment providers shall not include— (i) prevention only providers; and (ii) a private practitioner who is licensed by a State licensing board and whose practice is limited to non-intensive outpatient care. (5) Substance use disorder treatment services The term substance use disorder treatment services means any prevention services, core medical services, recovery and support services, early intervention services, and harm reduction services authorized under this title. . 4. Amendments to the Controlled Substances Act (a) Certifications Part C of the Controlled Substances Act ( 21 U.S.C. 821 et seq. ) is amended by adding at the end the following: 313. Certifications relating to diversion controls and misbranding (a) Definitions In this section— (1) the term covered dispenser — (A) means a dispenser— (i) that is required to register under section 302(a)(2); and (ii) dispenses a controlled substance in schedule II; and (B) does not include a dispenser that is— (i) registered to dispense opioid agonist treatment medication under section 303(g)(1); and (ii) operating in that capacity; (2) the term covered distributor means a distributor— (A) that is required to register under section 302(a)(1); and (B) distributes a controlled substance in schedule II; (3) the term covered manufacturer means a manufacturer— (A) that is required to register under section 302(a)(1); and (B) manufactures a controlled substance in schedule II; (4) the term covered officer , with respect to a covered person means— (A) in the case of a covered person that is not an individual— (i) the chief executive officer of the covered person; (ii) the president of the covered person; (iii) the chief medical officer of the covered person; or (iv) the chief counsel of the covered person; and (B) in the case of a covered person that is an individual, that individual; and (5) the term covered person means— (A) a covered dispenser; (B) a covered distributor; or (C) a covered manufacturer. (b) Certifications relating to diversion controls Not later than 180 days after the date of enactment of this section, and each year thereafter, each covered officer of a covered person shall submit to the Attorney General, for each controlled substance in schedule II dispensed, distributed, or manufactured by the covered person, a certification— (1) signed by the covered officer; and (2) certifying that— (A) the covered person maintains effective controls against diversion of the controlled substance into channels other than legitimate medical, scientific, research, or industrial channels; (B) all information contained in any record, inventory, or report required to be kept or submitted to the Attorney General by the covered person under section 307, or under any regulation issued under that section, is accurate; and (C) the covered person is in compliance with all applicable requirements under Federal law relating to reporting suspicious orders for controlled substances. (c) Certifications relating to misbranding (1) In general Not later than 180 days after the date of enactment of this section, and each year thereafter, each covered officer of a covered manufacturer shall submit to the Secretary, for each controlled substance in schedule II manufactured by the covered manufacturer, a certification— (A) signed by the covered officer; and (B) certifying that the controlled substance is not misbranded, as described in section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ). (2) Notification to the Attorney General (A) Failure to submit certifications Not later than 30 days after the date on which a covered officer of a covered manufacturer is required to submit a certification under paragraph (1) and fails to do so, the Secretary shall notify the Attorney General of the failure by the covered officer to submit the certification. (B) False certifications relating to misbranding Not later than 30 days after the date on which the Secretary becomes aware that a certification submitted under paragraph (1) contains a materially false statement or representation relating to the misbranding of a controlled substance with respect to the year for which the certification is submitted, the Secretary shall notify the Attorney General that the certification contains the materially false statement or representation. . (b) Offenses Part D of title II of the Controlled Substances Act ( 21 U.S.C. 841 et seq. ) is amended by adding at the end the following: 424. Certifications by covered officers (a) Definitions In this section, the terms covered dispenser , covered distributor , covered manufacturer , covered officer , and covered person have the meanings given those terms in section 313. (b) Offenses (1) Failure to submit certifications (A) Certifications relating to diversion controls It shall be unlawful for a covered officer of a covered person to fail to submit a certification required under section 313(b), without regard to the state of mind of the covered officer. (B) Certifications relating to misbranding It shall be unlawful for a covered officer of a covered manufacturer to fail to submit a certification required under section 313(c)(1), without regard to the state of mind of the covered officer. (2) Submission of false certifications (A) False certifications relating to diversion controls It shall be unlawful for a covered officer of a covered person to submit a certification required under section 313(b), without regard to the state of mind of the covered officer, that contains a materially false statement or representation relating to the information required to be certified under that section for the year for which the certification is submitted. (B) False certifications relating to misbranding It shall be unlawful for a covered officer of a covered manufacturer to submit a certification required under section 313(c)(1), without regard to the state of mind of the covered officer, that contains a materially false statement or representation relating to the misbranding of a controlled substance with respect to the year for which the certification is submitted. (c) Penalties (1) Civil penalties Except as provided in paragraph (2), a covered officer who violates subsection (b) shall be subject to a civil penalty of not more than $25,000. (2) Criminal penalties A covered officer who knowingly violates subsection (b)(2) shall be subject to criminal penalties under section 403(d). (d) Comprehensive Addiction Resources Fund (1) Establishment There is established in the Treasury a fund to be known as the Comprehensive Addiction Resources Fund . (2) Transfer of amounts There shall be transferred to the Comprehensive Addiction Resources Fund 100 percent of— (A) any civil penalty paid to the United States under this section; and (B) any fine paid to the United States under section 403(d) for a knowing violation of subsection (b)(2) of this section. (3) Availability and use of funds Amounts transferred to the Comprehensive Addiction Fund under paragraph (2) shall— (A) remain available until expended; and (B) be made available to supplement amounts appropriated to carry out title XXXIV of the Public Health Service Act. . (c) Criminal penalties Section 403 of the Controlled Substances Act ( 21 U.S.C. 843 ) is amended— (1) in subsection (d)(1)— (A) by inserting or knowingly violates section 424(b)(2) after any person who violates this section ; and (B) by striking violation of this section and inserting such a violation ; and (2) in subsection (f)— (A) in paragraph (1), by striking or 416 and inserting or section 416, or knowing violations of section 424(b)(2) ; and (B) in paragraph (3), by inserting or knowing violations of section 424(b)(2) before the period at the end. (d) Technical and conforming amendments The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 ( Public Law 91–513 ; 84 Stat. 1236) is amended— (1) by inserting after the item relating to section 311 the following: Sec. 312. Suspicious orders. Sec. 313. Certifications relating to diversion controls and misbranding. ; and (2) by inserting after the item relating to section 423 the following: Sec. 424. Certifications by covered officers. . (e) Effective date The amendments made by subsections (b) and (c) of this section shall take effect on the date that is 180 days after the date of enactment of this Act. 5. General limitation on use of funds Amounts appropriated or provided under this Act, or an amendment made by this Act, shall be used only for the public health purposes described in this Act (or amendments) and shall not be used to increase the incarceration or institutionalization of individuals with substance use disorder. 6. Federal drug demand reduction activities (a) Publication of list (1) Amendment Section 705(f) of the Office of National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1704(f) ) is amended by inserting at the end the following new paragraph: (5) Publication of list The Director shall publish online a complete list of all drug control program grant programs and any other relevant information included in the system developed under paragraph (1). . (2) Deadline and frequency Not later than one year after the date of the enactment of this Act, and annually thereafter, the Director of National Drug Control Policy shall publish the list required under section 705(f)(5) of the National Drug Control Act of 1998, as added by paragraph (1). (b) National Drug Control Strategy Section 706(c)(1) of the National Drug Control Act of 1998 ( 21 U.S.C. 1705(c)(1) ) is amended by adding at the end the following new subparagraph: (O) A review of all federally funded demand reduction activities, including an evaluation of— (i) the effectiveness of those activities; (ii) the contribution of those activities to demand reduction activities funded by State, local, and Tribal governments; and (iii) whether any duplication or inefficiency in federally funded demand reduction activities needs to be addressed. .