TAK

FY 2025 Budget Resolution - Pharmaceutical Related Provisions Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflati

Rare Disease Issues. H.R.4299: Protecting Patient Access to Cancer and Complex Therapies Act. General Medicare/Medicaid Issues. Implementation of Inflation Reduction Act of 2022.

General issues related to drug research and innovation.

Issues related to health care, the Food and Drug Administration (FDA), oncology coverage, mental health, opioid abuse, 340B Program, drug pricing, importation of biopharmaceuticals, international pharmaceutical supply chain, plasma therapy, step therapy, and PBM reform; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; S.891, Bipartisan Health Care Act; Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Executive Order. General issues related to Medicare and Medicaid, including: Part D Medicare Program; Medicare Part B reimbursement; CMMI Drug Pricing Demonstration Programs; Drug Pricing; Inflation Reduction Act of 2022 (P.L.117-169) implementation. Issues related to tax reform; R&D tax credit; orphan drug tax credit; Section 899; H.R.1, One Big Beautiful Bill Act (P.L.119-21) implementation. Biopharmaceutical innovation and patent policy issues. Bayh-Dole march-in rights policy issues. Issues related to pharmaceutical IP, supply chai

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to H.R. 4299 - Protecting Patient Access to Cancer and Complex Therapies Act. Issues related to Plasma-Derived Therapies; Issues related to the 340B Program - Public Health Service Act (PL 78-410); Issues related to National Priority Voucher (CNPV) program.

International tax reform.

Issues related to drug pricing.

FY 2025 Budget Resolution - Pharmaceutical Related Provisions Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment p

Issues related to health care, the Food and Drug Administration (FDA), oncology coverage, mental health, opioid abuse, 340B Program, drug pricing, importation of biopharmaceuticals, international pharmaceutical supply chain, plasma therapy, step therapy, and PBM reform; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; S.891, Bipartisan Health Care Act; Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Executive Order. General issues related to Medicare and Medicaid, including: Part D Medicare Program; Medicare Part B reimbursement; CMMI Drug Pricing Demonstration Programs; Drug Pricing; Inflation Reduction Act of 2022 (P.L.117-169) implementation; H.R.1, One Big Beautiful Bill Act (P.L.119-21) implementation. Issues related to tax reform; R&D tax credit; orphan drug tax credit; Section 899. Biopharmaceutical innovation and patent policy issues. Bayh-Dole march-in rights policy issues. Issues related to pharmaceutical IP, supply chai