No CRS summary available for this bill.
This section establishes definitions for terms used in the Act, including "(1) correctional facility," "(2) hepatitis C treatment" (i.e., a direct-acting antiviral drug approved under the Federal Food, Drug, and Cosmetic Act for treating hepatitis C virus infection), "(3) Indian health program," "(4) Secretary" (i.e., Secretary of Health and Human Services), "(5) State" (i.e., the 50 states, District of Columbia, Puerto Rico, Guam, American Samoa, Northern Mariana Islands, Federated States of Micronesia, Republic of the Marshall Islands, Republic of Palau, and U.S. Virgin Islands), and "(6) State or local correctional system."
This section establishes the Hepatitis C Elimination Program to coordinate federal activities aimed at eliminating hepatitis C virus (HCV), with implementation required not later than 90 days after enactment. Within 180 days of enactment, the Secretary of Health and Human Services must issue a national strategy and implementation plan that (1) identifies priority populations with higher HCV rates; (2) inventories relevant federal strategies, plans, policies, and programs, assessing gaps or duplications; (3) sets specific goals, objectives, and strategies for HCV prevention, detection, and treatment; and (4) defines performance metrics. The section further requires an advisory committee composed of individuals with HCV lived experience, clinicians, state and local public health officials, pharmacists, drug and diagnostic manufacturers, health plans and issuers, and others; an interagency working group including the heads (or designees) of CDC, HRSA, CMS, the Assistant Secretary for Mental Health and Substance Use, IHS, FDA, Assistant Secretary for Health, Bureau of Prisons, and other agencies; a public dashboard tracking progress via the metrics; stakeholder consultations; and reports to specified congressional committees not later than 90 days after the strategy's issuance and annually thereafter through September 30, 2032.
This section establishes a subscription program for hepatitis C treatments under which the Secretary of Health and Human Services (HHS) enters into agreements with drug manufacturers to purchase such treatments and provides for their distribution—without cost-sharing—to registered pharmacies and sites of dispensing, participating state and local correctional systems, Bureau of Prisons facilities, and Indian Health Service facilities for individuals in the covered population. The covered population consists of individuals diagnosed with hepatitis C who (1) are enrolled in a participating state Medicaid or CHIP program; (2) are confined (or were confined and released with incomplete treatment) in a participating state or local correctional facility or a Bureau of Prisons facility; (3) lack minimum essential coverage; or (4) receive care through an Indian health program. Participating states and programs must verify enrollment prior to dispensing. The section prohibits health care providers, pharmacies, and sites of dispensing from using other federal drug discount programs, including the 340B program, for hepatitis C treatments obtained through this program and directs HHS to enforce compliance through data sharing, audits, and supplemental guidance. Covered 340B entities may purchase hepatitis C treatments separately under 340B agreements if compliant.
This section establishes public health activities to support hepatitis C virus (HCV) elimination, including grants to states and political subdivisions for outreach, screening, diagnosis, treatment, and wraparound services for covered individuals (i.e., those within the covered population at increased risk of HCV infection), with funds allocated via a formula considering HCV incidence, morbidity, mortality, and anticipated covered population. The section further directs the Secretary to make awards to (1) opioid treatment programs and certified community behavioral health clinics for HCV testing and treatment; (2) Indian health programs and facilities in Tribal areas for testing, linkage to care, and treatment; (3) community health centers under section 330 of the Public Health Service Act to expand HCV testing, case management, and treatment and to build capacity for tracking referrals; (4) state, local, or territorial health departments, correctional systems, and community-based organizations to provide HCV testing and treatment in correctional facilities and continued care post-release; and (5) not more than 25 eligible entities under a pilot program for HCV care at Ryan White HIV/AIDS Program-funded facilities (title XXVI of the Public Health Service Act). (Thus, these activities supplement and coordinate with the Hepatitis C Elimination Program under section 3(a) and extend HCV services to high-risk settings such as prisons, tribal areas, and substance use treatment sites.)
This section appropriates $4,283,000,000 for FY2025, to remain available through FY2031, to the Secretary of Health and Human Services to carry out the Hepatitis C Elimination Program (established under section 3(a)) and related provisions in sections 3 and 5. It (1) limits the Secretary's administrative expenses for the program to 5% of the amount and (2) requires a $25 million transfer to the Federal Bureau of Prisons for related expenses.
This section eliminates the Part D deductible and all coinsurance or other cost-sharing for covered Part D drugs that are direct-acting antivirals for treating hepatitis C (i.e., highly effective curative oral medications) for plan years 2027 through 2031, subject to the Secretary's authority to delay implementation to 2028 if not feasible for 2027. The elimination applies to both standard Part D coverage under SSA section 1860D–2(b) and the low-income cost-sharing subsidy program under SSA section 1860D–14(a).
This section (1) subjects amounts appropriated pursuant to this Act and the amendments made by this Act to the requirements contained in Public Law 118-47 for funds provided under division D of such law; and (2) specifies that nothing in this Act supersedes section 416 of the Controlled Substances Act (21 U.S.C. 856), which prohibits knowingly opening, using, renting, or maintaining any place for manufacturing, distributing, or using a controlled substance (with criminal penalties of up to 20 years imprisonment and $500,000 fine for individuals, civil penalties up to $250,000 or twice gross receipts, and injunctive remedies).
This section limits the use of amounts appropriated pursuant to this Act and its amendments, notwithstanding section 4(b)(2), to carrying out the Act's provisions with respect to (1) U.S. citizens or (2) aliens in specified immigration categories, including lawful permanent residents, aliens paroled for at least one year, refugees, asylees, victims of a severe form of trafficking in persons, certain special immigrants and unaccompanied alien children, Afghan and Ukrainian parolees or special immigrants, and others as listed in subparagraphs (A) through (Q). (Thus, the restriction precludes funding for programs under 22 U.S.C. 7105(a) assisting integration or reintegration of foreign trafficking victims lacking such U.S. status.)