The FDA's Breakthrough Devices Program was established in 2008 to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval. Devices must meet specific criteria to be considered for the breakthrough pathway.
The Foundation and our partners – the Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) – have closely followed this initiative since it was proposed in August 2020. In October, we encouraged public comment on the matter from manufacturers and key stakeholders in the focused ultrasound field.
“The lag time between regulatory approval and reimbursement has historically been a major issue for focused ultrasound and many other new therapies,” said the Foundation’s Chief Scientific Officer Jessica Foley, PhD. “This ruling is a big win for the 60 million patients who are covered by Medicare and will now have access to the ‘breakthrough’ procedures that the FDA has deemed safe and effective. There is also now a more efficient adoption path for noninvasive technologies, such as focused ultrasound, to establish themselves among standards of care.”
During the new four-year coverage period, CMS is expected to specify what additional data, if any, would be needed to maintain long-term coverage.
This new rule also presents a great incentive for focused ultrasound manufacturers to apply for breakthrough designation by the FDA for their future or ongoing applications. Sponsors can submit a breakthrough designation request for a device at any time prior to sending their marketing submission. See CMS’s fact sheet for more information, including device eligibility and guidance for manufacturers.
See the CMS Press Release >
See AdvaMed’s Press Release >
MITA and Focused Ultrasound Foundation Voice Support for Medicare Coverage of Innovative Technology Proposed Rule November 2020
MITA and Focused Ultrasound Foundation Support Proposed Rule Eliminating Gap Between FDA Approval and Medicare Coverage September 2020
Focus Feature: Reimbursement for Focused Ultrasound October 2020
CMS Releases Proposed Rule Eliminating Gap between FDA Approval and Medicare Coverage: Comments Welcome October 2020
FDA Pathways to Expedite Patient Access to Innovative Medical Device Therapies October 2020
Foundation’s Partnerships Aim to Achieve Reimbursement October 2020
Patients and Physicians Advocate for Focused Ultrasound in Washington, DC March 2020