ARTICLE SUMMARY:
CMS reiterates its plan to cancel the streamlined path. Excerpted from Pathways’ Picks June 8: MDUFA Agreement, Medicare Plans, EU Parliament Response, and More.
CMS showed no signs of reversing its plan to repeal the streamlined path for FDA-designated breakthrough devices to qualify for add-on payments in a recent draft rule. In April, the agency proposed to end the “alternative pathways” for inpatient New Technology Add-on Payments and outpatient device pass-through payments, which have allowed more innovative devices to benefit from bonus payments to support early-stage adoption over the past six years. Under the proposal, starting next application cycle, companies with breakthrough devices will have to submit evidence of “substantial clinical improvement” to qualify for the bonus payments just like non-breakthrough devices. CMS floated the plan in April as part of its 2027 inpatient payment proposal. Last month, industry groups asked the agency to rethink the approach and suggested the upcoming outpatient payment proposal, since published on July 2, could offer an opportunity for CMS to seek more feedback. Instead, the agency simply reiterated its plan to cancel the alternative path for pass-through payments in the proposal.
Demonstrating the impact of the alternative pathway, in the outpatient proposal, CMS slated seven devices to start receiving pass-through payments in 2027, and all of them are breakthrough devices benefiting from the streamlined route. Another three breakthrough devices didn’t make the cut and none of the three non-breakthrough devices were able to qualify via the traditional route requiring evidence of substantial clinical improvement.