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CMMI GENEROUS Demo Medicare Part B ASP compliance 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 direct-to-consumer drug delivery policy options 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 next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel th

Issues around drug pricing. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act. Education about 340b program.

federal budget issues Medicare and Medicaid drug and coverage issues, orphan drugs IRA, drug pricing in federal programs, orphan drug issues, oncology, transparency

340B Program. Home Infusion for Part B Products. S.864: HELP Copays Act. Medicare Reimbursement for New Technologies. Pediatric Priority Review Voucher Program. General issues related to rare disease and orphan drugs. Diagnostics for patients with rare disease. Multi-Cancer Early Detection. H.R.1672: Maintaining Investments in New Innovation Act. H.R.946: ORPHAN Cures Act. Prescription drug pricing policy.

Issues related to Medicare Part D and Part B Pricing Reform; Issues related to the Medicaid Pricing reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act. Issues related to the 340B Program - Public Health Service Act (PL 78-410).

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mit

Issues related to the 340B Program - Public Health Service Act (P.L. 78-410). Issues related to Medicare Part D and Part B Pricing Reform; Issues related to the Medicaid Pricing reform; Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act.

Issues around drug pricing. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act.

federal budget issues Medicare and Medicaid drug and coverage issues, orphan drugs IRA, drug pricing in federal programs, orphan drug issues, oncology, transparency

340B Program. Home Infusion for Part B Products. S.864 - HELP Copays Act. Medicare Reimbursement for New Technologies. General issues related to rare disease and orphan drugs. Diagnostics for patients with rare disease. Multi-Cancer Early Detection. H.R.1672 - Maintaining Investments in New Innovation Act. H.R.946 - ORPHAN Cures Act. Prescription drug pricing policy.