Ensuring Access to Essential Drugs Act

This bill exempts certain orally administered drugs from Medicare Part D's manufacturer discount program. Specifically, it excludes drugs that: (1) received FDA approval under the standard new drug application process, and (2) have been granted a narrow CMS exception allowing them to be treated as noninnovator drugs under Medicaid rebates. The exemption applies directly to these specific drugs meeting both criteria, altering how their costs are calculated under Medicare Part D. This change affects drug manufacturers and Medicare beneficiaries by modifying the discount structure for these particular medications.