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ACR Summarizes 2024 Transitional Coverage for Emerging Technologies
Aug. 22, 2024
The American College of Radiology® (ACR®) prepared a detailed summary of the 2024 Transitional Coverage for Emerging Technologies (TCET) Pathway final procedure notice released by the Centers for Medicare and Medicaid Services (CMS) Aug. 7. The TCET pathway uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain Breakthrough Devices. TCET took effect Aug. 12.
CMS reviewed 150 public comments, including from ACR and is finalizing the TCET pathway with modifications and clarifications outlined in its detailed summary. Notably, CMS does not plan to accept more than five candidates into the TCET pathway per year; nominations will be reviewed quarterly. As the agency gains more experience with TCET, CMS will re-evaluate and adjust the pathway based on available resources. CMS will finalize an NCD for technologies accepted into the TCET pathway within six months of U.S. Food and Drug Administration (FDA) market authorization. Interested parties may submit a non-binding letter of intent to CMS to nominate a potentially eligible device for the TCET pathway approximately 18 to 24 months before anticipated FDA marketing authorization. The final notice requires manufacturers to have an approved evidence development plan before CMS initiates a national coverage analysis.
Additionally, CMS agrees that including the number of devices in the TCET pathway, the date of nomination, the date of acceptance and the date the NCD process is initiated, would be helpful and will incorporate this information into future iterations of the NCD Dashboard, which is updated quarterly.
Lastly, CMS intends to provide criteria for prioritizing TCET requests. The agency will hold a public comment period on its proposed approach.
For more information or if you have questions, contact Alicia Blakey, ACR Principal Economic Policy Analyst.
CMS reviewed 150 public comments, including from ACR and is finalizing the TCET pathway with modifications and clarifications outlined in its detailed summary. Notably, CMS does not plan to accept more than five candidates into the TCET pathway per year; nominations will be reviewed quarterly. As the agency gains more experience with TCET, CMS will re-evaluate and adjust the pathway based on available resources. CMS will finalize an NCD for technologies accepted into the TCET pathway within six months of U.S. Food and Drug Administration (FDA) market authorization. Interested parties may submit a non-binding letter of intent to CMS to nominate a potentially eligible device for the TCET pathway approximately 18 to 24 months before anticipated FDA marketing authorization. The final notice requires manufacturers to have an approved evidence development plan before CMS initiates a national coverage analysis.
Additionally, CMS agrees that including the number of devices in the TCET pathway, the date of nomination, the date of acceptance and the date the NCD process is initiated, would be helpful and will incorporate this information into future iterations of the NCD Dashboard, which is updated quarterly.
Lastly, CMS intends to provide criteria for prioritizing TCET requests. The agency will hold a public comment period on its proposed approach.
For more information or if you have questions, contact Alicia Blakey, ACR Principal Economic Policy Analyst.
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