CMS proposes expedited coverage pathway for new medical technologies

Wednesday, July 5, 2023

CMS is proposing a coverage pathway to achieve expedited and more predictable access to new medical technologies for Medicare beneficiaries. The Transitional Coverage for Emerging Technologies (TCET) pathway is designed to facilitate coverage for new treatments that usually need time to develop data proving their value, HealthLeaders reported.

Developed in partnership with the Agency for Healthcare Research and Quality, the new pathway uses current national coverage determination (NCD) and coverage with evidence development processes to expedite coverage of certain breakthrough devices, according to a CMS fact sheet.

CMS said the TCET pathway is intended to balance the following considerations when making coverage determinations:

  • Facilitating early, predictable, and safe beneficiary access to new technologies
  • Reducing manufacturers’ and innovators’ uncertainty about coverage by evaluating the potential benefits and harms of technologies early
  • Encouraging evidence development if evidence gaps exist

The new pathway will also help coordinate benefit category determination, coding, and payment reviews, according to the fact sheet.

Key elements to the TCET pathway include an evidence preview, or focused literature review, and an evidence development plan (EDP), which would be drafted by the developer to address any evidence gaps spotted in the evidence preview, HealthLeaders reported.

CMS said that candidates for the TCET pathway will include certain FDA-designated breakthrough devices that meet the following criteria:

  • Determined to be within a Medicare benefit category
  • Not already the subject of an existing Medicare NCD
  • Not otherwise excluded from coverage through law or regulation

Once a treatment has qualified for this pathway, Medicare coverage will remain in place as long as needed for the timely generation of evidence to inform clinicians’ and patients’ decisions, along with an additional year to allow manufacturers to finish their analysis, HealthLeaders reported.

CMS would then conduct an updated evidence review within six calendar months of the review date specified in the EDP to determine transitional coverage.

The agency is accepting comments on the pathway proposal until August 28.