ALKERMES, INC. for ALKERMES, INC.

Health Issues HCR

Ensure patient access to appropriate medications by limiting the unnecessary use of utilization management policies, including H.R. 2163/S. 464 the Safe Step Act; Policies impacting pharmaceutical development, reimbursement, and patient access and cost; H.R. 5539 - ORPHAN Cures Act; P.L. 115-97 - Tax Cuts and Jobs Act of 2017, Orphan Drug Tax Credit; Awareness of need for transparency and patient access within the 340B program; H.R. 9029 Labor, Health and Human Services, Education Appropriations, 2025; H.R. 9026 Commerce, Justice, Science, and Related Agencies Appropriations, 2025; H.R. 8580 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2025; H.R. 9747 Continuing Appropriations and Extensions Act, 2025 PDUFA Implementation and efficiency improvements at the FDA;

Contacted: Executive Office of the President (EOP); Substance Abuse & Mental Health Services Administration (SAMHSA); Health & Human Services, Dept of (HHS); Office of Natl Drug Control Policy (NDCP); HOUSE OF REPRESENTATIVES; SENATE; Natl Institutes of Health (NIH)

Bills named: S. 464 (118th), H.R. 8580 (118th), H.R. 9747 (118th), H.R. 5539 (118th), H.R. 9026 (118th), H.R. 9029 (118th), H.R. 2163 (118th)

Alcohol and Drug Abuse ALC

Expand funding and flexibility to address all substance use disorders;

Contacted: SENATE; Veterans Affairs, Dept of (VA); Substance Abuse & Mental Health Services Administration (SAMHSA); Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Justice, Dept of (DOJ)

Medicare/Medicaid MMM

Patient access and maintain six protected classes for depressions and schizophrenia under Medicare Part D; Inflation Reduction Act of 2022 implementation, Part D redesign phase in for small companies; Medicaid Drug Rebate Program proposed rule Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program;

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES