Medicare would auto-cover breakthrough devices for up to four years pending review

What does this do?

S 1717 would require Medicare to automatically cover FDA-designated breakthrough medical devices for up to four years while the government conducts a full review of whether to provide permanent coverage. Coverage would be denied only if the device is used outside its FDA-approved instructions or poses too great a risk to patients. If a manufacturer requests a formal permanent coverage decision, the government must complete that review before the four-year temporary period expires.

Who does it affect?

The bill primarily affects Medicare patients, including adults 65 and older and some younger people with disabilities. It also directly affects companies that manufacture advanced medical devices by creating a faster pathway to Medicare payment for new products.

Why does it matter?

Currently, a significant gap can exist between FDA approval of a new device and Medicare's agreement to cover it, meaning some patients may wait years before their insurance pays for the latest technology. The bill sets deadlines intended to prevent the government from delaying its permanent coverage decisions.

What does it cost, and who pays?

• $10M per year to CMS, 2026–2031
• Covers CMS implementation costs
• Six-year funding window