ARTICLE SUMMARY:
There is a long way to go, but CMS’ intent to catalyze medtech innovation has been palpable in recent years.
This column appeared in the September 2020 print issue of Market Pathways.
Encouraging medtech innovation has become more central to the Centers for Medicare and Medicaid Services’ mission in recent years. CMS Administrator Seema Verma often emphasizes the value new medical devices can bring to healthcare and the barriers to unlocking that value that she wants to remove. That has translated into specific policy actions ranging from updated guidance for local Medicare contractors, to streamlined payment pathways for Breakthrough Devices, to, most recently, the Medicare Coverage for Innovative Technology proposal covered in this issue of Market Pathways. (See “Medicare’s Breakthrough Coverage Proposal: Innovation, Evidence, and the Valley of Death”.)
These actions are as much about creating a system to stimulate future innovation as they are about addressing challenges faced by today’s technology. As AdvaMed’s Don May said about the potential impact of the MCIT proposal: “From a numbers perspective, it's pretty small. From a budget perspective, it's pretty small. But the impact on the broader community and the healthcare ecosystem and the innovation ecosystem is really big.” Part of the goal of the recent policymaking is to establish a clearer pathway for innovators so they can see the route to a viable market.
That said, these efforts by CMS are by no means a panacea. The reimbursement system is complex and not all devices interact cleanly with how the Medicare coverage, coding, and payment frameworks are designed. In particular, digital health tools, despite relaxed rules for telehealth and remote monitoring that have taken hold during the pandemic, are often still an awkward fit within the Medicare framework. Industry worries, for instance, that the MCIT proposal could leave out many Breakthrough health software tools if CMS approaches the issue too narrowly.
The agency also recently almost twisted itself into knots when considering how an artificial intelligence decision-support tool can fundamentally meet the thresholds for its new technology add-on payment. (See “AI Software Nets a Medicare Win, But CMS Remains Cautious in the Space”.)
But the arc at the Medicare agency appears to be at least bending toward innovation, and that has engendered more optimism in the medtech community about further improvements ahead.
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