S. 1717119th CongressIn committeeLatest action May 12, 2025Decoded by AI · checked against the record
Official title: Ensuring Patient Access to Critical Breakthrough Products Act of 2025
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
Senate bill S 1717 would give FDA-designated breakthrough medical devices automatic Medicare coverage for up to four years while a permanent coverage decision is made.
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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.
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.
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.
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Right now: a Senate committee is reviewing it. If the House changes it, it goes back to the Senate before reaching the President.
Latest action: — Read twice and referred to the Committee on Finance.