The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations.
CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to innovative and beneficial medical devices.
Now, a pathway called the Transitional Coverage for Emerging Technologies (TCET) program could take its place. CMS and medtech industry representatives have discussed the need for Medicare coverage reforms in two listening sessions (transcripts with webinar replay information are here and here).
In an Aug. 1 letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator and COO Jon Blum, AdvaMed called on them to issue a proposed rule this year.
“We believe that CMS, in order to advance its health equity and other goals, can and must play a critical role in advancing access to emerging innovations that would improve health outcomes for the array of Medicare beneficiaries it serves,” AdvaMed SVP Chandra Branham wrote in the letter.
“We also believe that we share a common goal — the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients, including the 42% of Medicare-eligible patients enrolled in Medicare Advantage organizations — which include high numbers of Black, Latino, and dual-eligible enrollees,” Branham continued.
AdvaMed offered a conceptual framework for the program covering participation, evidence generation, beneficiary protections, transparency, system readiness and follow-on devices.
The industry association also offered more detailed recommendations, such as a four-year minimum for national, transitional coverage and a flexible pathway to permanent coverage. Advamed posed the Investigational Device Exemption coverage criteria as a potential model for TCET.
The full letter and its recommendations can be downloaded at AdvaMed’s website (PDF).