To amend title XI of the Social Security Act to provide for the treatment of orphan drugs under the Medicare Drug Price Negotiation Program.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
Raises the orphan-drug exemption threshold under the Medicare Drug Price Negotiation Program for drugs whose only approved indications are for rare diseases or conditions.
Who Benefits and How
Manufacturers of qualifying single-indication orphan drugs could more easily remain outside the Medicare negotiation program.
Who Bears the Burden and How
Medicare and beneficiaries could lose some negotiation leverage and potential savings for qualifying orphan drugs.
Key Provisions
- Raises the relevant orphan-drug threshold from $200 million to $400 million for qualifying drugs.
- Applies the change to initial price applicability years beginning on or after January 1, 2028.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Raises the orphan-drug exemption threshold under the Medicare Drug Price Negotiation Program for drugs whose only approved indications are for rare diseases or conditions.
Key Policy Areas
Healthcare, Finance
Primary Purpose
Raises the orphan-drug exemption threshold under the Medicare Drug Price Negotiation Program for drugs whose only approved indications are for rare diseases or conditions.
Policy Domains
Main Provisions
Identified Gains
Contextual inference, no direct clause citation- Manufacturers of qualifying single-indication orphan drugs
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- Medicare and beneficiaries losing some negotiation leverage and potential savings
Contextual inference, no direct clause citation
Sponsors
Legislative Progress
IntroducedMr. Welch (for himself, Mr. Wyden, and Ms. Cortez Masto) …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Manufacturers of qualifying single-indication orphan drugs
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology