Congress Reintroduces Bill to Clarify Medicare Biosimilar Delay Rules
1 report, 1 independent
Updated Oct 8
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What happened
The Biosimilars Access and Affordability Act has been reintroduced in both the House of Representatives and the Senate. This bill would alter when biosimilar biological products are eligible for price negotiations under Medicare. Currently, Centers for Medicare & Medicaid Services (CMS) has generally implemented the Inflation Reduction Act’s biosimilar delay provision using narrow and somewhat subjective qualifying criteria.
From natlawreview.com
Why it matters
The proposal seeks to provide greater certainty regarding when the Inflation Reduction Act’s biosimilar delay applies. This clarity would make launch timing more consequential to negotiation exposure and potential rebates for manufacturers.
From natlawreview.com
Who's involved
- MedicareThe US federal health insurance program subject to the bill's changes.
- CMSThe administrative body responsible for implementing Medicare.
- house of representativesOne of the legislative bodies reintroducing the bill.
- CongressThe legislative body reintroducing the bill.
Keep exploring
The entities involved
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