H.R. 2542: Old Drugs, New Cures Act

This bill exempts manufacturers of certain long-standing drugs from paying specialized rebates under the Medicaid Drug Rebate Program and the Medicare Prescription Drug Inflation Rebate Program. (Under these programs, drug manufacturers pay rebates to state Medicaid programs for certain drugs covered under Medicaid and to the Centers for Medicare & Medicaid Services for certain drugs covered under Medicare.)

Specifically, manufacturers may request that a drug that would otherwise be considered a line extension under the Medicaid and Medicare rebate programs to instead be designated as a priority research drug. (A line extension refers to an oral dose of a new formulation of an existing drug, such as an extended release formulation, that would subject the drug to specialized rebates under the Medicaid and Medicare drug rebate programs.)

Under the bill, a drug qualifies as a priority research drug if (1) at least 10 years have elapsed since the drug was first approved, (2) the manufacturer is investigating a new use of the drug that would address a significant unmet need, and (3) the new use addresses a disease or condition that has a high prevalence among beneficiaries of Medicaid, Medicare, or other federal health care programs.

Written by the Congressional Research Service, Library of Congress.