CMS’ move to abolish ‘valley of death’ between FDA approval, Medicare imaging coverage draws praise
Imaging lobbyists are applauding proposed federal legislation that would grant quicker Medicare coverage of “breakthrough” medical devices, including in imaging.
Currently when the Food and Drug Administration approves such products, a lengthy process follows before the federal payment program can grant reimbursement. But a Centers for Medicare and Medicaid Services rule released Monday would instead grant instant coverage that would continue for four years.
Both the Medical Imaging Technology Alliance and Focused Ultrasound Foundation applauded the proposal on Wednesday. Jessica Foley, PhD, chief scientific officer of the latter, said it would create a “more efficient adoption path” for technologies including focused US imaging, while also bolstering outcomes.
“MITA strongly supports this pro-innovation rule that will improve patient care by giving seniors faster access to breakthrough technologies that otherwise perish in the ‘valley of death,” added alliance Executive Director Patrick Hope. “Too often, innovative devices are approved by the FDA but aren’t covered by Medicare until sufficient evidence has been collected. This creates a ‘Catch-22’ scenario in which, without adequate coverage or reimbursement, access to an FDA-approved treatment or therapy is limited to only those who can afford to pay out-of-pocket.”
The Medicare Coverage of Innovative Technology pathway, as it is called, would provide national Medicare coverage on the same day as FDA market authorization, and after the first four years, CMS may reevaluate a device based on clinical evidence that outcomes have improved.
In the Aug. 31 announcement, CMS said that some requests for National Coverage Determinations have languished on waiting lists since 2014. The agency is attempting to work through the backlog more quickly and hopes to reduce last year’s list of 11 down to two by the start of 2021.
“Arcane bureaucratic requirements have no business preventing seniors’ access to a technology that might save their lives,” CMS Administrator Seema Verma said in a statement Monday.
The agency is accepting comments on the proposal until Nov. 2. You can find the full rule here and a shorter fact sheet here.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.