ORPHAN Cures Act

This bill changes how Medicare can negotiate prices for rare-disease drugs. Today, Medicare can start negotiating some drug prices after a drug has been on the market for a number of years (7 years for drugs, 11 for biologics), starting in 2026. But drugs for a single rare disease are already excluded. The bill would expand that exclusion so that rare-disease drugs are kept out of negotiation even if they’re approved for more than one rare disease. It also stops the “age clock” from running during any time a drug is classified as a rare-disease drug, which delays when Medicare could negotiate its price later on .

In short, more rare-disease drugs would be shielded from Medicare price talks, and for a longer time. This could affect what Medicare pays and what patients with rare conditions see on their drug lists .

• Who is affected: Medicare enrollees, people who rely on rare-disease drugs, and drug makers that develop those medicines .
• What changes: Orphan drugs for one or more rare diseases are excluded from negotiation; the market-age timer pauses while a drug has orphan status .
• When: Medicare’s negotiation program begins in 2026; these changes would alter which drugs are included and when they become eligible .