GENENTECH

340B Program issues and patient access to pharmaceuticals, including related provisions in H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program." Legislative issues associated with patient access to treatment, including: the CMMI Most Favored Nation and related demonstration initiatives; and step therapy, including related provisions in H.R. 2630/S. 652, the Safe Step Act. Medical Supply Chain, including issues related to a new rating system; targeted action to support the diversification of certain supplies; additional funding to the Strategic National Stockpile (SNS) and more diverse stockpile; increasing flexibility for supply chains. Enhanced FDA reporting and risk mitigation plans for certain medicines. Incentives for antimicrobial and antiviral research, medical countermeasures, and novel product development.

Implementation issues affecting patient access to Medicare covered pharmaceuticals and biologics, including reimbursement adequacy, Medicare Parts B and D benefit parameters, coverage, and reimbursement requirements, including related provisions in H.R. 5376, the Inflation Reduction Act of 2022 (P.L. 117-169): Title 1, Subtitle B - Prescription Drug Pricing Reform: Part 1, Lowering Prices Through Drug Price Negotiation; Part 2, Prescription Drug Inflation Rebates; and Part 3, Part D Improvements and Maximum Out-of-Pocket Cap for Medicare Beneficiaries. Enhance Center for Medicare & Medicaid Innovation quality initiatives and patient access to Medicare Part B covered drugs, including advocacy related to the Most Favored Nation and related demonstration initiatives.

340B Program issues and patient access to pharmaceuticals, including related provisions in H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program." Legislative issues associated with patient access to treatment, including: the CMMI Most Favored Nation and related demonstration initiatives; and step therapy, including related provisions in H.R. 2630/S. 652, the Safe Step Act. Medical Supply Chain, including issues related to a new rating system; targeted action to support the diversification of certain supplies; additional funding to the Strategic National Stockpile (SNS) and more diverse stockpile; increasing flexibility for supply chains. Enhanced FDA reporting and risk mitigation plans for certain medicines. Incentives for antimicrobial and antiviral research and novel product development.