ARTICLE SUMMARY:
The Medicare agency finalized plans to cancel its “alternative pathway” to new technology add-on and device pass-through payments for FDA Breakthrough Devices. However, it agreed to add a transitional period allowing firms to access the streamlined route for the next two years if they get a breakthrough designation by September.
Devices under development via FDA’s breakthrough pathway will have two more years to try to qualify for new-technology Medicare bonus payments without meeting the high bar of “substantial clinical improvement.” After that, Breakthrough Devices will be subject to the same clinical standards as all other products, CMS affirmed July 31.
The agency agreed to the transition period but stood firm on its plans to remove for Breakthrough Devices a streamlined path to inpatient new-technology add-on payments (NTAPs) and outpatient device pass-through payments in its final FY 2027 hospital inpatient prospective payment system (IPPS) rule.
