Old Drugs, New Cures Act

This bill sets up a “priority research drug” label for certain older medicines and changes how Medicaid and Medicare count them in drug rebate rules. It aims to encourage testing old drugs for new uses that could help people with big unmet medical needs, especially those in federal health programs. A drug can qualify if it’s been on the market at least 10 years, is being studied for a new use with no approved alternative, and that condition affects many patients in federal programs. The government must create the request process within 90 days and decide within 60 days after a company applies. For these designated drugs, certain rebate and price rules won’t apply the usual way, including rules that treat new versions as “line extensions” under Medicaid and Medicare, and a special “best price” rule in Medicaid for selected drugs.

Key points

• Who is affected: Patients in federal programs (like Medicaid, CHIP, Medicare Part D low-income subsidy, 340B clinics, and VA), and drug makers researching new uses for older drugs.
• What changes: Creates a “priority research drug” designation and excludes these drugs from certain rebate and price formulas, including “line extension” treatment in Medicaid and Medicare and a Medicaid “best price” special rule.
• When: The government must set up the designation process within 90 days of the law taking effect and make decisions within 60 days of each request.