Ensuring Access to Essential Drugs Act
Sponsored By: Representative Garbarino
Introduced
Summary
Exempts certain orally administered drugs from the Medicare Part D manufacturer discount program. Drugs qualify only if they have a Food and Drug Administration new drug application (NDA) approval under section 505 and a Centers for Medicare & Medicaid Services (CMS) narrow exception that reclassifies them as noninnovator multiple‑source drugs for Medicaid rebates.
Show full summary
- Drug manufacturers: Makers of orally administered drugs that meet both the FDA NDA and the CMS narrow reclassification exception are no longer required to participate in the Part D manufacturer discount program for those products.
- Medicare Part D plans and program rules: The list of drugs that trigger manufacturer discounts in Part D is narrowed so that specified orally administered drugs are excluded from the discount calculations.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Fewer Medicare discounts on some oral drugs
If enacted, this bill would remove some oral drugs from Medicare Part D’s manufacturer discount program. The carve-out would apply only to pills approved by the FDA as new drugs and given a narrow CMS exception to be treated like a non‑innovator, multiple‑source drug under Medicaid rules. If your Part D plan covers one of these drugs, plan costs could rise. That could mean higher premiums or copays for some enrollees. The change would take effect upon enactment.
Sponsors & CoSponsors
Sponsor
Garbarino
NY • R
Cosponsors
Harshbarger
TN • R
Sponsored 3/6/2025
Suozzi
NY • D
Sponsored 3/6/2025
Roll Call Votes
No roll call votes available for this bill.
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