ARTICLE SUMMARY:
In this week’s roundup: A House Ways and Means subcommittee heard about barriers to medical innovation including device reimbursement; implications from the imminent end of the COVID-19 Public Health Emergency; updates from Europe, including a crucial document from notified bodies and a clinical trials report guidance; and news from FDA, EPA, UK NICE, and Singapore.
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What we’re watching for:
[Updated to incorporate discussion points that were addressed during the May 10 Ways and Means subcommittee hearing]
Innovation hearing. Serial device entrepreneur and Stanford Byers Center for BioDesign Director Josh Makower, MD, was among those testifying at a House subcommittee hearing May 10 to examine “policies that will have negative effects on medical innovation and reduce patient access to therapies.” Makower spotlighted challenges to securing Medicare reimbursement for innovative medical technologies and the need for a streamlined pathway. He, along with several members of the Ways and Means Health Subcommittee, urged CMS to release a meaningful alternative the Medicare Coverage of Innovative Technology (MCIT) automatic coverage pathway for FDA Breakthrough Devices, which was repealed in 2021. The hearing comes as device firms are anxiously waiting for CMS to release that alternative, the Transitional Coverage for Emerging Technologies (TCET) proposal. But privately, in recent weeks, some industry advocates have lowered their expectations that the TCET plan will entail much more than small tweaks to current Medicare coverage/Coverage with Evidence Development policies. Industry groups also support legislation that has been introduced in Congress to codify an enhanced version of MCIT. Several sponsors of the bill spoke in support of more predictable, streamlined medtech coverage during the hearing (although most of the session focused on discussion of drug coverage and pricing controversies). “We do remain hopeful that CMS will act soon, but any further delay would not feel like a commitment to the Medicare patients who may be waiting for new, breakthrough treatments to help alleviate their suffering,” AdvaMed CEO Scott Whitaker said in response to the hearing. “However, we will continue our work with CMS, as well as Members of Congress, to move this important medical breakthrough program forward.”
