[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 665 Introduced in Senate (IS)]

<DOC>






119th CONGRESS
  1st Session
                                 S. 665

 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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fatal Overdose Reduction Act of 
2025''.

SEC. 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.''.

SEC. 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.
                                 <all>