II 119th CONGRESS 1st Session S. 665 IN THE SENATE OF THE UNITED STATES February 20, 2025 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 the Health Engagement Hub Demonstration Program to increase access to treatment for opioid use disorder and other substance use disorders, and for other purposes.

1. Short title This Act may be cited as the Fatal Overdose Reduction Act of 2025 . 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 opioid use disorder and other substance use disorders 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)(A) (which may be further defined and interpreted by the Secretary as necessary to carry out the demonstration program) 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 the required items and services described in paragraph (3)(B) (which may be further defined and interpreted by the Secretary as necessary to carry out the demonstration program) that are provided by a certified Health Engagement Hub participating in the demonstration program to individuals who are eligible for medical assistance under a State plan under this title or under a waiver of such plan. Such guidance shall specify that the prospective payment system established by a State shall only apply to the required items and services described in paragraph (3)(B)(i) that are provided in accordance with the requirements applicable under this title to the provision of such services to individuals who are eligible for medical assistance under the State plan under this title or under a waiver of such plan. (C) Clarification regarding payment for furnishing medical assistance for prescribed drugs or covered outpatient drugs Statements that, with respect to the provision of medical assistance for prescribed drugs or covered outpatient drugs (as defined in section 1927(k)) by a certified Health Engagement Hub to individuals who are eligible for medical assistance under the State plan under this title or under a waiver of such plan and in accordance with the requirements applicable under this title— (i) the prospective payment system established by a State for purposes of the demonstration program shall not include payment for such medical assistance (other than with respect to the service of providing a prescription or administering a drug if needed); and (ii) a certified Health Engagement Hub that provides medical assistance for prescribed drugs or covered outpatient drugs (as so defined) shall not be precluded from receiving payment under the State plan under this title or under a waiver of such plan for the provision of such medical assistance, that is in addition to, and separate from, any payment made to the certified Health Engagement Hub under such prospective payment system. (D) Eligibility of an Indian tribe, tribal organization, Urban Indian organization, or consortia Such requirements as the Secretary determines appropriate for an Indian Tribe or Tribal organization, (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), a tribal consortia, or an Urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), to apply for, and be selected to participate in, the demonstration program. To the extent practicable, such requirements shall be similar to the requirements applicable to a State desiring to participate 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 satisfy the following requirements: (i) The organization demonstrates that the organization is equipped to serve individuals who are eligible for medical assistance under a State plan under this title or under a waiver of such plan (including individuals who are eligible for such assistance but are not enrolled in such State plan or waiver), as well as uninsured individuals (as defined in section 1902(ss)), and provide such populations with access to a range of social and medical services, in a drop-in manner and without prior appointment. (ii) The organization provides (in a manner reflecting person-centered care) the services specified in subparagraph (B) which, if not available directly through the organization, are provided or referred through partnerships or formal contracts with other providers. (iii) The organization demonstrates that in selecting the location for the Health Engagement Hub, the organization prioritized placement in communities disproportionately impacted by overdose and other harms related to substance use disorder (as further defined by the Secretary), including rural areas, geographically isolated areas within the State, tribal areas, urban centers with under-resourced behavioral health infrastructure, communities with significant numbers of individuals experiencing homelessness, and communities negatively impacted by the criminal-legal system. (iv) The organization uses evidence-based models to increase engagement and improve outcomes for individuals with opioid use disorder or other substance use disorders, such as social work empowerment models, motivational interviewing models, shared decision-making models, and other evidence-based recovery and support services. (v) The organization demonstrates that the organization is equipped to provide— (I) overdose education and distribution of a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency reversal of known or suspected opioid overdose (such as naloxone); (II) safer substance use education and supplies; (III) safer-sex supplies; (IV) emotional support and counseling services to reduce harms associated with substance use, using a trauma-informed approach; and (V) access, within 4 hours of the arrival of an individual with opioid use disorder or other substance use disorder at a Health Engagement Hub, to drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and biological products licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for treatment of opioid use disorder or substance use disorder with a strong evidence base of significantly reducing mortality, directly or through partnerships or formal contracts with other providers in a manner that insures consistency of care and care coordination. (vi) The organization demonstrates that the organization is equipped to provide, as selected by the organization, 1 or more services to address health-related social needs, which may include— (I) identification services (such as assistance with obtaining a government-recognized form of identification); (II) employment counseling; (III) recovery support services, including services that promote a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential through career, education, or community-building; (IV) family reunification services, including services that help the reunification of family members separated by the legal system or foster system; and (V) criminal-legal services, including the provision of legal clinical consultation, legal information and advice, legal referrals, and legal advocacy or retainer. (vii) The organization demonstrates that the organization is equipped to 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). (viii) The organization agrees to provide services to an uninsured individual (as defined in section 1902(ss)), with fees for such services imposed on a sliding scale basis that— (I) is developed at the discretion of a certified Health Engagement Hub or the State; (II) is based on an individual's ability to pay; and (III) provides that the organization shall not reject or limit services on the basis of an individual's ability to pay or place of residence. (B) Scope of items and services The items and services specified in this subparagraph are the following, subject to the requirements applicable under this title to the provision of such items and services: (i) Required items and services paid for through the prospective payment system (I) Harm reduction services and supplies. (II) 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) primary mental health and substance use disorder services, as defined by the Secretary, including screening, assessment, and referrals to higher levels of care; (bb) shared decision-making for patients and providers for opioid use disorder or substance use disorder under which a patient and provider discuss the patient’s diagnosis and condition together and evaluate treatment options together; (cc) wound care and supplies; (dd) infectious disease vaccination, screening, testing, and, to the extent practicable, treatment (including for HIV, sexually transmitted infections, and hepatitis); (ee) sexual and reproductive health services provided directly or through partnerships or formal contracts with other providers; and (ff) secure medication storage and inventory policies and procedures for patients experiencing homelessness or housing insecurity. (III) Medication management, as specified by the State, including with respect to the types of conditions for which medication management must be at a minimum available. (IV) Targeted case management. (V) Peer support services. (VI) Community health outreach and navigation services, including services that guide patients through social and health care systems to connect with services and service providers that the patients need. (ii) Prescribed drugs and covered outpatient drugs paid separate from the prospective payment system Directly or through partnerships or formal contracts with other providers, prescribed drugs and covered outpatient drugs (as defined in section 1927(k)) for which medical assistance is available under the State plan under this title or under a waiver of such plan that are provided in accordance with requirements applicable under this title and, if applicable, a rebate agreement in effect under section 1927. (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 where the Health Engagement Hub is located 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 nurse or licensed practical nurse who can provide or supervise staff providing medication management, targeted case management, wound care, and vaccine administration. (III) At least 1 part-time or full-time licensed behavioral health staff who is qualified to assess or provide counseling about potential treatment options or about the need for treatment. (IV) At least 1 full-time equivalent staff who is a peer support specialist, community health worker, or recovery coach, with priority for hiring staff for such positions who are individuals with lived and living experience with substance use. (V) Full-time outreach, engagement, and ongoing care navigation staff, including peer support specialists, community health workers, and recovery coaches. At least 50 percent of such staff shall be individuals with lived and living experience with substance use. (ii) Staffing through contractual arrangements with partner agencies An organization may enter into a contractual arrangement with a partner agency, such as a Federally-qualified health center, to satisfy the minimum staffing requirements specified in clause (i) with staff who are on-site at the Health Engagement Hub. (D) Experience An organization shall have a demonstrated history of at least 12 months of providing opioid use disorder or substance use disorder treatment services to individuals. (E) Community advisory board An organization shall have a community advisory board composed of individuals with lived and living experience with substance use that meets, at a minimum— (i) on 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; administration There is appropriated, out of any funds in the Treasury not otherwise appropriated, $60,000,000 to the Secretary for purposes of implementing, administering, and making planning grants to States as soon as practicable for purposes of developing proposals to participate in the demonstration program and obtaining technical assistance from the Secretary with respect to the design and implementation of the demonstration program, for expenditures attributable to collecting and reporting the information and data required under paragraph (6)(B), and for administrative expenses of the Secretary to carry out this subsection, to remain available until expended. (5) State demonstration programs (A) In general Not later than 9 months after the date on which the Secretary first awards a planning grant under paragraph (4), the Secretary shall solicit applications to participate in the demonstration program solely from States awarded such a grant. (B) Application requirements An application to participate in the demonstration program shall include the following: (i) A description of the target population (including the estimated number of individuals in such population) to be served by the State under the demonstration program. (ii) An assurance that at least 50 percent of the Health Engagement Hubs in the State shall be located in— (I) a county (or municipality or other unit of local government, 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 are available from the State, is higher than the most recent available national average overdose death rate per 100,000 people over the past 3 years, 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). (vi) Verification that the State has agreed to pay for the items and services required to be paid for through the prospective payment system at the rate established under the prospective payment system. (vii) 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 up to 10 States to participate in the demonstration program. (ii) Priority In selecting States to participate in the demonstration program, the Secretary shall prioritize selecting States— (I) with the highest opioid- or stimulant-involved overdose death rates; and (II) in a manner that ensures, to the extent practicable, geographic diversity across the United States. (D) Length of demonstration programs A State selected to participate in the demonstration program shall participate in the program for a 5-year period. (E) Waiver of certain requirements The Secretary shall waive section 1902(a)(1) (relating to statewideness) and section 1902(a)(10)(B) (relating to comparability) 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 For each quarter occurring during the period for which the demonstration program is conducted, the Secretary shall pay a State participating in the demonstration program an amount equal to 90 percent (or, if higher, the Federal medical assistance percentage otherwise applicable to the State and year under section 1905 (without regard to this subparagraph)) of the amounts expended by the State for the quarter for items and services provided by certified Health Engagement Hubs (directly or through partnerships or formal contracts with other providers) at the rate established under the prospective payment system established by the State for purposes of the demonstration program to individuals who are eligible for, and enrolled under, the State plan or under a waiver of such plan. (ii) Ensuring no duplicate pps payments The guidance required under paragraph (2)(B) shall include guidance on how the Secretary will determine, if 2 or more prospective payment systems may apply to a service provided by a certified Health Engagement Hub (directly or through partnerships or formal contracts with other providers) to an individual who is eligible for, and enrolled under, the State plan or under a waiver of such plan, which prospective payment systems shall apply for purposes of determining the amount to be paid to a State for a quarter under clause (i). (iii) Application Payments made 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) Initial implementation During the first 2 years in which a State participates in the demonstration program under paragraph (5), the State shall submit to the Secretary such information as the Secretary may require relating to the implementation and initial operation of the demonstration program. (B) Annual state reports (i) In general Beginning with the 3rd year in which a State participates in the demonstration program under paragraph (5), the State 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 opioid use disorder and other substance use disorders, health services for individuals who use drugs, and other social services under the State’s plan under this title or under a waiver of such plan in the area or areas of the State targeted by the demonstration program, as compared to other areas of the State. (II) An assessment of the extent to which Health Engagement Hubs are reducing opioid and stimulant overdose mortality rates and the rate of adherence to prescribed medication for opioid use, hospitalization rates, recovery rates, and housing status for the populations served by the Health Engagement Hubs as compared to populations that are not served by the Health Engagement Hubs. (III) Data and information comparing for populations served by the Health Engagement Hubs the racial and socioeconomic demographics, housing status, employment, and other metrics, as recommended by the Secretary, of such populations. (IV) A description of the successes of the demonstration program. (V) Recommendations for improvements to the demonstration program, including whether the demonstration program should be continued, expanded, modified, or terminated. (ii) Data availability Each State selected to participate in the demonstration program under paragraph (5) shall agree, as a condition of such selection, to cooperate with data collection for purposes of the national implementation evaluation under paragraph (7). (iii) Information and data collection and reporting expenditures From amounts made available under paragraph (4)(A)(i), the Secretary shall make payments to States for expenditures attributable to collecting and reporting the information and data required under this subparagraph. (C) Reports to congress and the Comptroller General (i) In general Beginning with the 3rd year in which a State participates in the demonstration program under paragraph (5), the Secretary shall submit to Congress and the Comptroller General of the United States, and make publicly available, an annual report 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 national implementation evaluation required by paragraph (7). (7) National implementation evaluation (A) In general The Secretary shall contract with an entity that meets the requirements of subparagraph (B)(ii) to solicit public input and conduct a national implementation evaluation of the planning grants awarded under paragraph (4) and the State demonstration programs under paragraph (5) to determine the reach, effectiveness, adoption, and implementation of the demonstration program in each such State and to allow for a complete assessment of the impact of Health Engagement Hubs in each State participating in the demonstration program. (B) Requirements (i) Information The evaluation shall include information on the characteristics of the individuals who received 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— (I) have documented experience conducting implementation evaluations of health and social services programs; and (II) satisfy such additional eligibility criteria as the Secretary may establish. . 3. Government Accountability Office report Not later than 18 months after receipt of the annual State reports and the findings and conclusions of the national implementation evaluation under paragraph (6)(C) of section 1903(cc) of the Social Security Act (as added by section 2), the Comptroller General of the United States shall provide to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the Secretary’s evaluation of the Health Engagement Hub Demonstration Program established under such section.