H.R. 1922 — Ensuring Access to Essential Drugs Act

This section exempts certain orally administered drugs from the Medicare Part D manufacturer discount program (i.e., the program requiring manufacturers to provide discounts on applicable Part D drugs for beneficiaries in the coverage gap). The exempted drugs are those (1) for which a new drug application was approved under section 505 of the Federal Food, Drug, and Cosmetic Act and (2) that have been granted a narrow exception by the Centers for Medicare & Medicaid Services permitting reclassification as a noninnovator multiple source drug under the Medicaid drug rebate program.