HRS Comments on CMS' Transitional Coverage for Emerging Technologies (TCET) Proposal | Heart Rhythm Society

HRS Comments on CMS' Transitional Coverage for Emerging Technologies (TCET) Proposal

In late August, HRS submitted comments to CMS voicing support for the creation of an alternative, expedited pathway for Medicare coverage of emerging devices and diagnostics in order to improve access to new technologies for Medicare beneficiaries.

Regulatory Updates

HRS' comments were in response to CMS' recently proposed pathway for transitional coverage for emerging technologies (TCET), which would use existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain devices designated as "breakthrough" by the U.S. Food and Drug Administration (FDA). The proposal would provide time-limited coverage to five FDA-designated breakthrough devices annually.

The TCET pathway was introduced as an alternative to a final rule published in 2021, titled the Medicare Coverage of Innovative Technology (MCIT), which would have allowed Medicare to immediately cover medical devices designated as "breakthrough technology" by the FDA for four years after they received market authorization. This rule was subsequently repealed out of concern that it did not sufficiently account for the outcomes of Medicare beneficiaries. 
However, at that time, the Biden Administration noted its commitment to finding alternative ways to improve access to breakthrough technologies and pledged to readdress this issue through future rulemaking.

Despite its overall support for an expedited Medicare coverage pathway for emerging devices and diagnostics, HRS voiced concern that the new TCET proposal is not as expeditious as the previously proposed MCIT pathway and urged CMS to consider ways to make "day 1" coverage possible. HRS also voiced concern about CMS' proposal to limit TCET nominations to five technologies per year and the lack of specific criteria regarding how CMS will select candidates eligible for the pathway. Finally, HRS urged CMS to expand expedited coverage pathways beyond devices to include diagnostics and drugs.

Along with HRS, numerous medical device groups, including the Advanced Medical Technology Association (AdvaMed), also requested that CMS incorporate digital health technologies into this proposed expedited coverage pathway.