CMS New Technology Proposed Rule Aims to Improve Access to Device Innovations
June 29, 2023 - On June 22nd, CMS released its long-awaited proposed procedural notice that outlines a new voluntary, expedited Medicare coverage pathway for certain FDA-designated Breakthrough Devices. Under the Transitional Coverage for Emerging Technologies (TCET), manufacturers would be able to address any evidence gaps through fit-for-purpose studies, where the study design, analysis plan, and data are appropriate for the question the study aims to answer.
On June 22nd, CMS released its long-awaited proposed procedural notice that outlines a new voluntary, expedited Medicare coverage pathway for certain FDA-designated Breakthrough Devices. Under the Transitional Coverage for Emerging Technologies (TCET), manufacturers would be able to address any evidence gaps through fit-for-purpose studies, where the study design, analysis plan, and data are appropriate for the question the study aims to answer. The notice also includes newly proposed criteria as part of an updated Coverage with Evidence Development (CED) guidance document and a National Coverage Analysis Evidence Review guidance document, both of which "propose a substantial transformation to our approach to coverage reviews and evidence development."
As a reminder, in January 2021, the Trump Administration published a final rule, Medicare Coverage of Innovative Technology (MCIT), that would have allowed Medicare to immediately cover medical devices designated as "breakthrough technology" by the FDA for four years after they received market authorization, and also defined the elusive "reasonable and necessary" standard. After the transition of administrations, the Biden Administration withdrew the rule out of concern that it would lead to coverage of devices without a requirement for evidence that such devices are reasonable and necessary, or improved outcomes, for Medicare beneficiaries.
The Biden Administration's proposed alternative to the MCIT was informed by a series of stakeholder feedback opportunities, including a formal comment period at the time the MCIT was proposed for withdrawal, and two listening sessions on how to improve the Medicare coverage process. Read details on the Procedural Notice for the TCET pathway, including a CMS blog and CMS fact sheet, as well as the new Coverage with Evidence Development and Evidence Review, on the CMS' website.
HRS will continue to analyze the proposed rule and keep members informed prior to the comment deadline.