This blog post explores the CMS and AHRQ's proposed TCET pathway, which aims to improve beneficiary access, reduce coverage uncertainty, encourage evidence development and coordinate benefit categories for emerging technologies. It also discusses eligibility criteria for breakthrough devices and the self-nomination process for manufacturers.

Transitional Coverage for Emerging Technologies

On 22 June 2023, the Centers for Medicare and Medicaid Services (CMS) issued a notice with comment period regarding the process CMS proposes to use for providing Transitional Coverage for Emerging Technologies (TCET) through the National Coverage Determination (NCD). 

CMS will accept comments from the public on the proposed TCET pathway for 60 days after the date of publication.

The newly proposed TCET pathway, developed in partnership with the Agency for Healthcare Research and Quality (AHRQ), is intended to balance multiple considerations when making coverage determinations. 

These include:

  • Facilitating early, predictable and safe beneficiary access to new technologies
  • Reducing uncertainty about coverage by evaluating the potential benefits and harms of technologies with innovators early on
  • Encouraging evidence development if notable evidence gaps exist for coverage purposes

In addition, the TCET pathway will allow any evidence gaps to be addressed through fit-for-purpose studies.

Fit-for-purpose studies are those where the study design, analysis plan, and study data can appropriately answer the research question(s). 

The TCET pathway will also assist in coordination of benefit category determination, coding and payment reviews.

Breakthrough Devices

CMS is coordinating with the Food and Drug Administration (FDA) and manufacturers of Breakthrough Devices to ensure timely Medicare coverage decisions following the FDA market authorization. Not all devices are eligible for the TCET pathway.  

Candidates for the TCET pathway includes devices that are: 

  • Certain FDA-designated Breakthrough Devices 
  • Fall within a Medicare benefit category
  • Not already coverage of an existing Medicare NCD
  • Not excluded from coverage through law or regulation  

For the TCET pathway, CMS is using the current NCD and Coverage with Evidence Development (CED) processes. Coordination with the AHRQ will continue. Evidence development to support Medicare coverage is a key component of the TCET pathway.

TCET Nomination

Manufacturers can self-nominate for voluntary participation in the TCET pathway. CMS will review the nomination, which includes an initial meeting with the manufacturer, discussions with FDA and a benefit category determination. CMS will notify the manufacturer if it accepts the manufacturer’s nomination for the TCET pathway.  In those cases where CMS does not accept a nomination, CMS will meet with the manufacturer and discuss other coverage pathways.  

CMS and manufacturers have the option to withdraw from TCET anytime up until CMS opens the NCD by posting the tracking sheet.

How RQM+ Can Help

At RQM+, we know that the path to reimbursement is not linear, and we have the experience to guide clients to the best solution from day one. We have expertise across a broad range of devices and throughout the entire reimbursement product lifecycle. Our reimbursement services range from initial reimbursement strategy development to post-approval market access support.

If you'd like to begin a conversation about how we can help, please complete our contact form below.

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