ARTICLE SUMMARY:
CMS’ final Transitional Coverage for Emerging Technologies program looks very similar to what the agency proposed last June: that is, from the device industry’s perspective, insufficient to address the market access challenges at hand. Still, the TCET path, now open for nominations, shouldn’t be ignored as a tool for developers of big-ticket medtech to leverage. Here’s a first look at the ups, downs, and question marks for the new policy.
Health officials and medtech companies have been negotiating on developing a streamlined path to Medicare coverage for new devices for decades, so when CMS published its final notice establishing the Transitional Coverage for Emerging Technologies pathway in early August it was an important milestone. From the device industry’s standpoint, however, the results are underwhelming.
TCET in a nutshell is CMS’ effort to jumpstart the existing national coverage determination/coverage with evidence development (NCD/CED) process for select FDA Breakthrough Devices. It is designed to start the national coverage analysis process sooner, in advance of FDA authorization; enhance interactions between CMS, manufacturers, and FDA; and offer companies a clearer picture of the evidence that will be needed to support long-term Medicare coverage for a new technology.
The goal, CMS says, is to finalize NCDs for TCET-selected technologies, typically linked to an evidence-collection requirement, within six months of FDA go-ahead. “TCET represents a substantial transformation of how CMS conducts coverage reviews and is responsive to extensive feedback from interested parties,” the agency contends in the August 7 notice.
But many in industry, while expressing appreciation that CMS is taking steps to improve the current NCD/CED process, see it as too limited, and as a missed opportunity to establish a completely novel fast-track pathway that more seamlessly fills the gap between FDA authorization and sufficient reimbursement for a larger swath of devices.
