The Centers for Medicare and Medicaid Services (CMS) released a final procedural notice outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies. uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain U.S. Food and Drug Administration (FDA)-designated breakthrough devices. In addition to the TCET procedural notice, CMS finalized updated criteria in its .
The 黑料网® (黑料网®) tracked the proposed procedure notice since July 2023, developed a detailed summary and submitted comments to CMS in August 2023. The College continues to review the final procedure notice and associated coverage documents and will soon provide a detailed summary.
TCET is voluntary for manufacturers with intent to reduce uncertainty about coverage options through a pre-market evaluation of potential harms and benefits of technologies while identifying any important evidence gaps.
CMS, in its , says the new TCET pathway increases the number of NCDs it will conduct per year, and supports both improved patient care and innovation by providing a clear, transparent and consistent coverage process while maintaining robust safeguards for the Medicare population. CMS anticipates accepting up to five TCET candidates per year and, for technologies accepted into and continuing in the TCET pathway, its goal is to finalize an NCD within six months after FDA market authorization.
Congress recently re-introduced legislation () that would expedite access to breakthrough devices for Medicare beneficiaries. The bill would allow designated devices to be covered temporarily by Medicare during a four-year transitional period. CMS would have to assign payment codes for the devices within three months of FDA approval and establish a process for continued coverage after the transitional period expires.
CMS for anyone interested in submitting a nomination for the TCET pathway. The agency will review nominations quarterly, with the first submission deadline Oct. 31.
For more information or if you have questions, contact Alicia Blakey, 黑料网 Principal Economic Policy Analyst.