Bill > HR2542

This bill, known as the "Old Drugs, New Cures Act," aims to create a process for designating and supporting priority research drugs in Medicare and Medicaid. Specifically, the bill establishes a mechanism for drug manufacturers to request designation of a drug as a "priority research drug" if it meets certain criteria: the drug must be at least 10 years old, be under investigation for a new indication that addresses a significant unmet medical need, and target a condition with high prevalence among federal healthcare program beneficiaries. Once designated, these priority research drugs would be excluded from certain calculations related to manufacturer rebates and pricing, such as line extension definitions in Medicaid and Medicare Part D. The goal is to incentivize pharmaceutical companies to continue researching and developing new uses for older drugs, particularly for conditions that significantly impact federal healthcare program participants. The bill requires the Secretary of Health and Human Services to create a process for drug designation within 90 days and to make designation decisions within 60 calendar days of receiving a request. This approach could potentially encourage continued medical research and innovation for existing drugs.

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https://www.congress.gov/bill/119th-congress/house-bill/2542/all-info