ARTICLE SUMMARY:
CMS’ proposed repeal of its planned automatic temporary coverage pathway for FDA Breakthrough Devices sends a bad signal to medtech investors and innovators. But it’s worth taking time to see what the agency does next on this issue, and other policy matters with an even more expansive impact on the device industry, before coming to any final conclusions about CMS’ plans for the sector, opines Executive Editor David Filmore.
CMS said this month it plans to repeal the Medicare Coverage of Innovative Technology (MCIT) program before the expedited coverage pathway even gets started. That decision has led some in the device industry to feel burned. After years of talks with CMS under several presidential administrations about the prospect of a quicker, more predictable coverage pathway for practice-changing innovations, having a final rule pulled back at the last moment was a “stunning reversal,” one executive told me.
At the same time, the practical impact of the reversal will likely be minimal for many medtech firms. At most, a handful of devices each year would have been able to access the MCIT pathway, offering four years of automatic national Medicare coverage for FDA-approved Breakthrough Devices. And fewer still would be in the bucket of gaining coverage only due to the presence of MCIT, as opposed to already-existing local or national coverage pathways, or claim-by-claim coverage.
What MCIT offers is more surety, more predictability for most potentially paradigm-shifting innovations that are also inherently the most risky propositions. The promise of MCIT is the positive signal it would send to innovators and to investors of a more supportive reimbursement environment for these projects (and the expanded access to treatments for patients in need). It is the type of policy that could lead investors to greenlight more potentially disruptive medtech efforts, rather than play it safer with more incremental updates, advocates of the program say.
The MCIT repeal proposal could be viewed as the opposite sort of signal, warning prospective investors off of big-time projects. That’s what medtech executives and the start-up community fear.
