ASTRAZENECA PHARMACEUTICALS LP

Health Issues

FDA modernization policy issues Reauthorization of newborn screening programs General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA

TargetedSENATE · HOUSE OF REPRESENTATIVES · White House Office · Food & Drug Administration (FDA) · Centers For Medicare and Medicaid Services (CMS)

Medicare/Medicaid

Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act