TALEEN MEKHDJAVAKIAN

H.R. 9599 The SECURE 340B Act Pharmaceutical supply chain manufacturing Policies related to the use of international reference pricing in Medicare/Medicaid 340B rebate model Part B and Part D drugs Medicare drug price negotiation Medicare Part D reform Definition of Qualified Single Source Drug (QSSD) for purposes of Medicare drug price negotiation Medicare patient access to cancer screening Medicare patient access to rare disease therapies Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to the US manufacturing of pharmaceuticals Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals