Ensuring Access to Essential Drugs Act

This bill would change Medicare’s Part D rules so that some specific oral medicines do not have to provide the usual manufacturer discount. It applies to drugs that were originally approved like brand-name drugs, but later got a special, narrow reclassification by Medicare/Medicaid as a “non‑innovator multiple source” drug under the Medicaid rebate program. In short, these reclassified oral drugs would be exempt from the Part D manufacturer discount program.

Key points

• Who is affected: People on Medicare who use certain oral drugs; drug manufacturers; Part D plans.
• What changes: These specific reclassified oral drugs would no longer be required to give the standard manufacturer discount under Part D.
• How it’s defined: The exemption applies only if the drug is orally taken, was approved through the standard new drug application process, and got a narrow CMS exception to be treated like a non‑innovator multiple source drug in Medicaid’s rebate program.