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The Old Drugs, New Cures Act amends Medicare and Medicaid law to create a new designation for "priority research drugs"—drugs approved at least 10 years ago that manufacturers are investigating for new indications addressing significant unmet medical needs. Drugs receiving this designation would be excluded from "line extension" classifications for purposes of calculating manufacturer rebates under both programs, potentially reducing rebate obligations for qualifying drugs. The bill requires the Secretary of Health and Human Services to establish a process for manufacturers to request this designation and to approve requests within 60 days if specified criteria are met.
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