ARTICLE SUMMARY:
Breakthrough Devices would no longer enjoy a fast track to Medicare inpatient new technology add-on payments (NTAPs) and outpatient pass-through payments under a proposal from CMS. If finalized, the change would likely lead to a massive drop of new awards from the bonus payment programs that have grown in recent years.
Editor’s note: The figure in the article was updated April 22 to include the number of devices proposed for FY 2027 new technology add-on payments.
The Medicare agency plans to beef up clinical evidence requirements for FDA-designated Breakthrough Devices to qualify for bonus payments.
CMS unveiled the proposal in a draft rule published April 10. If finalized, the plan would repeal an “alternative pathway” that was first established in 2021 allowing Breakthrough Devices to win hospital inpatient new technology add-on payments (NTAPs) and outpatient device pass-through payments without demonstrating “substantial clinical improvement” over existing care.
