CMS proposes pathway to earlier breakthrough device coverage

Dive Insight:
Device makers and patient advocates have been pushing CMS for a faster pathway for reimbursement of new medical technologies. It takes more than five years for breakthrough medical technologies to gain even partial Medicare coverage after approval from the Food and Drug Administration, according to research from the Stanford Byers Center for Biodesign at Stanford University.

The new CMS proposal aims to facilitate earlier access for Medicare beneficiaries to certain FDA-designated breakthrough devices while encouraging evidence development if gaps exist.

The TCET plan calls for manufacturers to address evidence gaps through studies designed to answer specific questions. The so-called “fit for purpose” studies would address the design, analysis plan and data appropriate to answer those questions.

The pathway would use CMS’ national coverage determination (NCD) and coverage with evidence development processes to expedite Medicare reimbursement of certain breakthrough devices, the agency said.

For breakthrough devices in the new pathway, CMS’ goal is to finalize the TCET NCD within six months after FDA market authorization. The agency said it intends to have that coverage only long enough to facilitate generation of evidence that can lead to a long-term Medicare coverage determination.

The TCET pathway also would help coordinate benefit category determination, coding and payment reviews, CMS said.

AdvaMed’s Whitaker said the group continues to support immediate coverage for FDA-approved technologies, but noted the industry and CMS share a common goal of establishing an expeditious coverage process “based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients.”

In March, U.S. House legislators introduced the Ensuring Patient Access to Critical Breakthrough Products Act that would require Medicare to temporarily cover breakthrough medical devices for four years while the CMS developed a permanent coverage determination.

CMS released three proposed guidance documents in connection with the new pathway: Coverage with Evidence Development, Evidence Review and Clinical Endpoints Guidance for Knee Osteoarthritis. The public has 60 days to comment on the plan.

(Updates with statement from AdvaMed, background on proposed legislation.)