Old Drugs, New Cures Act

This bill amends the Social Security Act to create a new category of "priority research drugs" that are excluded from being treated as line extensions of existing drugs for manufacturer rebate calculations under Medicare and Medicaid.

Sec. 2, Priority research drugs: The bill requires the Secretary of Health and Human Services to establish a process for drug manufacturers to request designation of a covered outpatient drug as a priority research drug. To qualify, at least 10 years must have passed since the drug's original approval, the manufacturer must be investigating the drug for a new indication that addresses a significant unmet medical need with no approved alternative, and that new indication must be for a disease or condition with high prevalence among federal health care program beneficiaries (defined as at least 33% of claims in the target population paid for by Medicaid, CHIP, Medicare Part D with subsidies, the 340B drug discount program, or VA health programs). The bill then excludes priority research drugs from the Medicaid definition of line extension, from the Medicaid best price special rule for selected drugs, and from the Medicare definition of line extension.