Pharmacy Benefit Managers (PBM) reform. Pharmaceutical IP and patent reform. S. 142, Preserve Access to Affordable Generics and Biosimilars Act. S. 150, Affordable Prescriptions for Patients Act of 2023. S. 1214, RARE Act. H.R. 4368, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024. H. Rept. 118-24, S. Rept. 118-44 -- Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations. S. 2131, To provide for a limitation on availability of funds for Independent Agencies, National Historical Publications and Records Commission, Grants Program for fiscal year 2024. Issues related to the Orphan Drug Tax Credit. Issues related to the deduction of research and development expenditures. H.R. 1350, Camerons Law. H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023. 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. Issues pertaining to implementation of the Inflation Reduction Act, H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Medicare patient access to rare disease therapies, Part B and Part D drugs. Value-based payment arrangements. Efforts to improve coding, coverage, and access for rare disease therapies. General issues related to diagnostic reimbursement. S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act. Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to clinical trial diversity. Issues related to lung cancer screening. Issues related to drug shortages. Issues related to workforce development. Issues related to the biopharmaceutical supply chain. Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). Issues related to rare disease patients with employer sponsored insurance. Issues related to Reform of pharmacy benefit managers. Issues related to the Cancer Moonshot Initiative. Issues related to Medicare reimbursement of patient navigators. Issues related to 340B. Issues related to drug shortages. Issues related to electronic prescribing labeling. 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. H.R. 1503, Prescription Information Modernization Act of 2023. H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.
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