AdvaMed to CMS: “1,138 Days Without Breakthrough Coverage is Harming Seniors”

AdvaMed, the Medtech Association, unveiled a timer on the organization’s website to track the number of days since the Centers for Medicare and Medicaid Services (CMS) ended the coverage pathway for FDA-approved breakthrough medical devices. Beginning with the Agency’s decision to delay implementation of the Medicare Coverage for Innovative Technology (MCIT) rule in March 2021, Medicare beneficiaries have waited 1,138 days for an updated rule giving them and their doctors access to breakthrough medical treatments.

“For three years, AdvaMed, our member companies, and patients across the country have been waiting for CMS to make good on its own promise to ensure Medicare coverage for life-saving FDA-approved breakthrough medical technologies. It has been 1,138 days since the agency first promised to replace the bipartisan policy it repealed. This delay is actively harming seniors who cannot access the tests and treatments they need,” said Scott Whitaker, President and CEO of AdvaMed. “Our industry has provided feedback to CMS, answered countless questions from policymakers, and even testified before Congress about the cost of this inaction. And while HHS Secretary Becerra recently told the Senate Finance Committee that more time was needed to get the policy right, the reality is that CMS has been working on this for more than three years. How much more time does CMS need? Patients are waiting, and many do not have the luxury of waiting long. CMS must act now.”

On March 14 of this year, HHS Secretary Xavier Becerra told the Senate Committee on Finance that he wanted to “make sure that we get [TCET] out as quickly as we can. We’ve got to get it right because we want to make sure people have access.” 
 
A week later on March 20, Secretary Becerra told the U.S. House Committee on Ways & Means in response to a direct question from Rep. Blake Moore (R-Utah) on when TCET would be finalized: “I wish I could give you a specific time frame. You know, this year there is a mad rush in trying to complete a lot of the work that we have. And why don’t I do this—why don’t I get back to you to give you a better sense? But I couldn’t right here today give you a sense of when that rule might come out.”

On March 15, 2021—1,138 days ago—the Centers for Medicare and Medicaid Services (CMS) announced it would delay implementation of the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”). Later that year, CMS rescinded the MCIT final rule, but promised to look into alternative options to improve coverage to breakthrough devices. More than three years later, CMS’s proposed alternative rule, Transitional Coverage for Emerging Technologies (TCET), has still not been finalized.