II 118th CONGRESS 2d Session S. 4430 IN THE SENATE OF THE UNITED STATES May 23, 2024 Ms. Cantwell (for herself and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XIX of the Social Security Act to establish a Health Engagement Hub demonstration program to increase access to treatment for opiate use disorder and other drug use treatment, and for other purposes.

1. Short title This Act may be cited as the Fatal Overdose Reduction Act of 2024 . 2. Health Engagement Hub demonstration program under Medicaid Section 1903 of the Social Security Act ( 42 U.S.C. 1396b ) is amended by adding at the end the following new subsection: (cc) Health Engagement Hub demonstration program (1) Authority The Secretary shall conduct a demonstration program (referred to in this subsection as the demonstration program ) for the purpose of increasing access to treatment for opiate use disorder and other drug use treatment through the establishment of Health Engagement Hubs that meet the criteria published by the Secretary under paragraph (2)(A). (2) Publication of guidance Not later than 6 months after the date of enactment of this subsection, the Secretary shall publish the following: (A) Certification criteria The criteria described in paragraph (3) for an organization to be certified by a State as a Health Engagement Hub for purposes of participating in the demonstration program. (B) Prospective payment system Guidance for States selected to participate in the demonstration program to use to establish a prospective payment system for services permitted under paragraph (3)(B) that are provided by a certified Health Engagement Hub participating in the demonstration program. (3) Criteria for certification of Health Engagement Hubs (A) General requirements In order to be certified as a Health Engagement Hub, an organization shall— (i) demonstrate that the organization is able to serve as an all-in-one location where individuals who are eligible for medical assistance under a State plan under this title or under a waiver of such plan who seek treatment for opiate use disorder or other drug use may access a range of social and medical services, in a drop-in manner and without prior appointment or proof of payment; (ii) provide the services specified in subparagraph (B) (in a manner reflecting person-centered care) which, if not available directly through the organization, shall be provided through formal relationships with other providers; (iii) demonstrate that in selecting the location for the Health Engagement Hub, the organization prioritized placement in communities disproportionately impacted by overdose, health issues, and other harms related to drug use, as well as areas that are medically underserved, rural, geographically isolated areas, tribal areas, or urban centers with under-resourced behavioral health infrastructure, including disadvantaged communities based on race, individuals experiencing homelessness, and communities negatively impacted by the criminal-legal system; (iv) give priority to establishing or adopting evidence-based models to increase engagement or improve outcomes for individuals with active, ongoing substance use, such as social work empowerment models approved by the Secretary, motivational interviewing models approved by the Secretary, or shared decision making models approved by the Secretary; and (v) meet— (I) the minimum staffing requirements described in subparagraph (C); (II) the experience requirement described in subparagraph (D); and (III) the community advisory board requirement described in subparagraph (E). (B) Scope of services The services specified in this subparagraph are the following: (i) Required services (I) Harm reduction services and supplies provided directly by the organization or under an arrangement with an organization that offers harm reduction services (which may include a syringe service program, a Federally-qualified health center, a community health center, a Tribal health program, or an opioid treatment program that offers such services), that include— (aa) overdose education and naloxone distribution; (bb) safer drug use education and supplies; (cc) safer-sex supplies; (dd) emotional support and counseling services to reduce harms associated with substance use, including trauma-informed care; and (ee) access or referral to medications and drugs approved by the Food and Drug Administration for treatment of opioid use disorder with a strong evidence base of significantly reducing mortality (such as methadone and buprenorphine) and other substances, including stimulants, within 4 hours. (II) Substance use disorder screening and brief intervention. (III) Patient-centered and patient-driven physical and behavioral health care that has walk-in availability, is offered during non-traditional hours, including evenings and weekends, and includes— (aa) shared decision making for patients and providers for opioid use disorder, stimulant use disorder, or both, under which a patient and provider discuss the patient's diagnosis and condition together and evaluate treatment options together; (bb) primary mental health and substance use disorder services, including screening, assessment, and referrals to higher levels of care; (cc) wound care; (dd) infectious disease vaccination, screening, testing, and, to the extent practicable, treatment (including for HIV, sexually transmitted infections, and hepatitis testing and treatment); (ee) access or referral to sexual and reproductive health services; (ff) assessment and linkage or referrals to psychiatric services and other specialty care; and (gg) secure medication storage and inventory policies and procedures for patients experiencing homelessness or housing insecurity. (IV) Care coordination, complex case management, and other case management, care navigation, and care coordination services that may include— (aa) education and assistance with obtaining housing, transportation, and other public assistance benefits, including enrollment in the State plan under this title or under a waiver of such plan; (bb) identification services (such as assistance with obtaining a government-recognized form of identification); (cc) employment counseling; (dd) recovery support counseling; (ee) family reunification services; and (ff) criminal-legal services. (V) All services that may be provided under the Outreach Site/Street Place of Service code (POS Code 27 as of October 1, 2023) (or a successor place of service code). (VI) Community health outreach and navigation services to engage with and conduct outreach to community members that is provided by outreach and engagement staff described in subparagraph (C)(i)(IV). (ii) Optional services (I) Services and supplies to meet basic needs, including food, clothing, and hygiene supplies. (II) Evidence-based and culturally appropriate behavioral health services. (III) Medication management for physical and mental health conditions. (C) Minimum staffing requirements (i) In general The minimum staffing requirements specified in this subparagraph are the following: (I) At least 1 part-time or full-time health care provider who is licensed to practice in the State and is licensed, registered, or otherwise permitted, by the United States to prescribe controlled substances (as defined in section 102 of the Controlled Substances Act) in the course of professional practice. (II) At least 1 part-time or full-time registered professional nurse or licensed practical nurse who can provide medication management, medical case management, care coordination, wound care, vaccine administration, and community-based outreach. (III) At least 1 part-time or full-time licensed behavioral health staff who is qualified to assess and provide counseling and treatment recommendations for substance use and mental health diagnoses. (IV) Full-time outreach, engagement, and ongoing care navigation staff, including peer counselors, community health workers, and recovery coaches. At least 50 percent of such staff shall be individuals with a personal history of drug use. (ii) Staffing through arrangements with partner agencies An organization may enter into an arrangement with a partner agency, such as a Federally-qualified health center, to satisfy the minimum staffing requirements specified in clause (i). (D) Experience An organization shall have a demonstrated history of at least 12 months of service provision to individuals who use drugs, including those who continue with substance use while receiving health and social services. (E) Community advisory board An organization shall have a community advisory board composed of individuals with a history of substance use, or who continue with substance use, that meets, at a minimum, on— (i) a monthly basis, to review program utilization data and provide feedback to the organization; and (ii) on a quarterly basis, with the executives or board of directors of the organization to provide input on service delivery and receive feedback on actions taken based on previous feedback provided by the community advisory board. (4) Planning grants (A) In general Not later than 1 year after the date of enactment of this subsection, the Secretary shall award planning grants to States for the purpose of developing proposals to participate in the demonstration program. (B) Amount of grant The amount of a grant awarded to a State under this paragraph shall be sufficient to pay 100 percent of the actual costs expended by a State to carry out the activities required under subparagraph (C). (C) Use of funds A State awarded a planning grant under this paragraph shall solicit input on the development of a proposal to participate in the demonstration program from patients, providers, harm reduction service providers, social service providers, and other stakeholders, with respect to— (i) identifying and certifying organizations as Health Engagement Hubs for purposes of participating in the demonstration program; and (ii) establishing a prospective payment system for services provided by a certified Health Engagement Hub participating in the demonstration program, in accordance with the guidance issued under paragraph (2)(B). (D) Funding Out of any funds in the Treasury not otherwise appropriated, there are appropriated to the Secretary such sums as are necessary to carry out this paragraph, to remain available until expended. (5) State demonstration programs (A) In general Not later than 2 years after the date of enactment of this subsection, the Secretary shall solicit applications solely from the States awarded a planning grant under paragraph (4) to participate in the demonstration program. (B) Application requirements An application to participate in the demonstration program shall include the following: (i) A description of, including the estimated number of individuals in, the target population to be served by the State under the demonstration program. (ii) An assurance that at least 1/2 of the Health Engagement Hubs in the State shall be located in— (I) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention; or (II) an area of the State that is designated under section 332(a)(1)(A) of the Public Health Service Act as a mental health professional shortage area. (iii) A description of the prospective payment system that is to be tested under the demonstration program. (iv) A list of the certified Health Engagement Hubs located in the State that will participate in the demonstration program. (v) Verification that each such certified Health Engagement Hub satisfies the requirements described in paragraph (3)(A). (vi) A description of the scope of the services that will be paid for under the prospective payment system (which includes at a minimum the required services described in paragraph (3)(B)(i)) that is to be tested under the demonstration program. (vii) Verification that the State has agreed to pay for such services at the at the rate established under the prospective payment system. (viii) Any other information that the Secretary may require relating to the demonstration program with respect to determining the soundness of the proposed prospective payment system. (C) Selection criteria (i) In general The Secretary shall select from among the applications submitted at least 10 States to participate in the demonstration program based on geographic and demographic diversity. (ii) Priority In addition to the criteria specified in clause (i), the Secretary shall prioritize selecting States with the highest rates of opioid- or stimulant-involved overdose death rates. (D) Length of demonstration programs A State selected to participate in the demonstration program shall participate in the program for a 2-year period. (E) Waiver of certain requirements The Secretary shall waive section 1902(a)(1) (relating to statewideness), section 1902(a)(10)(B) (relating to comparability), and any other provision of this title which would be directly contrary to the authority under this subsection as may be necessary for a State to participate in the demonstration program in accordance with this paragraph. (F) Payments to States (i) In general The Secretary shall pay a State participating in the demonstration program the Federal matching percentage specified in clause (ii) for amounts expended by the State for medical assistance for services provided through certified Health Engagement Hubs to individuals enrolled under the State plan (or under a waiver of such plan) consisting of medications and drugs approved by the Food and Drug Administration for treatment of opioid use disorder and other substances, including stimulants, and the services specified by the State in its application under subparagraph (B)(vi), at the rate established under the prospective payment system established by the State for purposes of the demonstration program. (ii) Federal matching percentage The Federal matching percentage specified in this clause is— (I) with respect to medical assistance described in clause (i) that is furnished to a newly eligible individual described in paragraph (2) of section 1905(y), the matching rate applicable under paragraph (1) of that section; and (II) with respect to medical assistance described in clause (i) that is furnished to an individual who is not a newly eligible individual (as so described), but who is eligible for medical assistance under the State plan under this title or under a waiver of such plan, the enhanced FMAP applicable to the State under section 2105(b). (iii) Application Payments to States made under this subparagraph shall be considered to have been made under, and are subject to, the requirements of this section. (6) Reports (A) Annual State reports (i) In general Each State selected to participate in the demonstration program under paragraph (5) shall submit an annual report to the Secretary on the demonstration program that includes the following: (I) An assessment of the extent to which Health Engagement Hubs funded under the demonstration program have increased access to treatment for opiate use disorder and other drug use treatment, health services for individuals who use drugs, and other social services under State plans under this title or under waivers of such plans in the area or areas of States targeted by the demonstration program compared to other areas of the State. (II) An assessment on the impact of Health Engagement Hubs on reducing opioid and stimulant overdose mortality rates and the rate of adherence to prescribed medication for opioid use, hospitalization rates, and housing status for the population served by a Health Engagement Hub as compared to populations that are not served by a Health Engagement Hub. (III) A description of the successes of the demonstration program. (IV) Recommendations for improvements to the demonstration program, including whether the demonstration program should be continued, expanded, modified, or terminated. (ii) Funding Out of any funds in the Treasury not otherwise appropriated, there are appropriated such sums as are necessary, to remain available until expended, for purposes of making payments to States for expenditures attributable to collecting and reporting the information required under this subparagraph. (B) Reports to congress (i) In general The Secretary shall submit an annual report to Congress that describes the information, findings, and recommendations in the annual State reports submitted to the Secretary under subparagraph (A). (ii) Implementation evaluation results The Secretary shall include with the first 3 annual reports submitted by the Secretary under this subparagraph the findings and conclusions of the implementation evaluation required by paragraph (7). (7) Implementation evaluation (A) In general The Secretary shall solicit public input and fund an implementation evaluation of the planning grants awarded under paragraph (4) and the initial set of States selected for the demonstration program under paragraph (5) to determine the reach, effectiveness, adoption, and implementation of the demonstration program in each such State to document the degree to which the services were implemented as intended and allow for a complete assessment of the impact of the Health Engagement Hubs in each such State. (B) Requirements (i) Information The evaluation shall include information on the characteristics of the individuals who receive services, service utilization metrics over time (including by staff role), and input from interviews with such individuals and staff. (ii) Eligible entities In order to be eligible to conduct the evaluation, an entity shall have documented experience conducting implementation evaluations of health and social services programs for individuals who use drugs. (C) Funding Out of any funds in the Treasury not otherwise appropriated, there are appropriated to the Secretary such sums as are necessary to carry out this paragraph, to remain available until expended. . 3. Government Accountability Office report (a) In general Not later than 6 months after the conclusion of the demonstration program established under subsection (cc) of section 1903 of the Social Security Act ( 42 U.S.C. 1396b ), as added by section 2, the Comptroller General of the United States shall conduct and publish a comparative analysis on the impacts of the health engagement hubs certified under such program (in this section referred to as health engagement hubs ) compared to the impacts of other opioid treatment programs and health care organizations that offer behavioral health care or substance use disorder services. (b) Content of analysis The analysis required under this section shall include the following: (1) Data and information analyzing differences in rates among individuals who receive behavioral health care or substance use disorder services through a health engagement hub and among individuals who receive such care or services through a program or organization referred to in subsection (a) for each of the following factors: (A) Changes in rates of mortality. (B) Changes in rates of recidivism. (C) Rates of relapse. (D) Rates of hospital and emergency department utilization. (E) Frequency of visits for care or services. (F) Rates of successful intervention through the administration of buprenorphine or other medication approved by the Food and Drug Administration for the treatment of substance use disorder. (2) Data and information comparing the racial and socioeconomic demographics, housing status, employment, and other metrics, as recommended by the Secretary of Health and Human Services, of the population groups that receive behavioral health care or substance use disorder services through a health engagement hub or through a program or organization referred to in subsection (a).