AdvaMed, MDMA Comments Show Support and Concern Over CMS Coverage of Breakthrough Devices

AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing that the proposal is limited in nature and doesn’t cover enough innovative devices.

Addressing CMS’ Transitional Coverage for Emerging Technologies (TCET) notice, which when finalized will replace the Medicare Coverage for Innovative Medical Technologies final rule, MDMA said it believes the proposed TCET pathway would “represent a positive, incremental step toward achieving the objectives underlying TCET and we urge CMS to move forward quickly with its implementation.”

But the group also expressed concerns about ongoing coverage delays, highlighting that recent peer-reviewed research from Stanford found that just “44 percent of novel technologies authorized by the FDA between 2016 and 2019 achieved nominal Medicare coverage by the end of 2022, and the median time to achieve this nominal coverage was actually 5.7 years” 

Read the MDMA comments here.

Read the AdvaMed comments here.

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