CMS Tightens Payment Standards for FDA Breakthrough Medical Devices

By Katie Palmer · STAT News · 2026-08-03

CMS Tightens Payment Standards for FDA Breakthrough Medical Devices

According to reporting from STAT News, federal regulators are ending a policy that allowed certain medical devices to receive bonus payments without providing evidence of clinical superiority. Starting in 2028, the Centers for Medicare and Medicaid Services will require products

According to reporting from STAT News, federal regulators are ending a policy that allowed certain medical devices to receive bonus payments without providing evidence of clinical superiority. Starting in 2028, the Centers for Medicare and Medicaid Services will require products