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HR 1922119th CongressIn Committee
Ensuring Access to Essential Drugs Act
Introduced: Mar 6, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs
The Ensuring Access to Essential Drugs Act would change how certain new, orally administered drugs are treated under Medicare Part D. Specifically, it would exempt from the Part D manufacturer discount program those oral drugs that (a) have a new drug application approved by the FDA and (b) CMS has granted a narrow exception allowing them to be reclassified as a noninnovator multiple-source drug under the Medicaid drug rebate program. In short, newly approved oral drugs with this CMS reclassification would not be subject to the Part D manufacturer discount requirements. This could reduce the discount obligations on these drugs for Part D plans and shift some pricing dynamics for these therapies.
Key Points
- 1Exemption target: The exemption applies only to orally administered drugs that are both FDA-approved (NDA) and have received a CMS narrow exception to be treated as noninnovator multiple-source drugs under the Medicaid rebate program.
- 2Scope: The exemption is limited to drugs taken by mouth (orally administered); other drug forms (injectables, inhaled, etc.) are not addressed by this specific change.
- 3Mechanism: The bill amends Section 1860D-14C(g)(2) of the Social Security Act to add a new subparagraph (C) establishing the exemption criteria.
- 4Policy intent: The sponsor’s title suggests a goal of “Ensuring Access to Essential Drugs,” though the immediate effect is a relaxation of Part D discount requirements for certain new oral drugs.
- 5Administration: The change would be implemented through CMS and Medicare program rules, without new funding in the bill, relying on existing statutory processes to designate the Medicaid rebate reclassification.
Impact Areas
Primary group/area affected: Medicare Part D beneficiaries who use newly approved oral drugs that meet the CMS reclassification criteria; their cost-sharing and access dynamics in the Part D program could change for those specific drugs.Secondary group/area affected: Pharmaceutical manufacturers of eligible oral drugs (potentially facing reduced mandatory discounts under Part D for these drugs); payers and Part D plans' drug formularies and pricing negotiations may be affected.Additional impacts: Could influence overall drug pricing strategies, the interplay between Medicare and Medicaid rebate policies, and the broader discussion about incentives for developing new oral therapies versus generic alternatives.
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