EBR WiSE Coverage Review Shows How Medicare's TCET Pathway Works

CMS has opened a national coverage review of leadless left ventricular endocardial pacing, the therapy delivered by EBR Systems' WiSE System, according to an announcement EBR filed with the Australian Securities Exchange on June 4, 2026. EBR said the review, which began on June 3, is a result of its work with CMS through the Transitional Coverage for Emerging Technologies pathway, known as TCET, and that the WiSE System was the first technology accepted into the program, about 18 months ago.

The timeline EBR quoted from CMS's tracking sheet runs as follows:

• June 3 to July 3, 2026: first public comment period;
• Dec. 3, 2026: proposed decision memo due, followed by a second 30-day comment period;
• March 3, 2027: final national coverage determination expected.

The device received FDA approval in April 2025, according to the company. EBR said CMS has also granted it a New Technology Add-on Payment for inpatient procedures and Transitional Pass-Through payment for outpatient procedures, both effective Oct. 1, 2025, and both based on a selling price of $63,300.

What TCET is

CMS finalized TCET in August 2024. Its fact sheet on the final notice describes a voluntary pathway that "uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain FDA-designated Breakthrough Devices." CMS said it anticipated accepting up to five candidates a year, with a goal of finalizing a national coverage determination within six months after FDA market authorization.

To be a candidate, a device must have breakthrough device designation from FDA, fall within a Medicare benefit category, not already be the subject of a national coverage determination and not be excluded from coverage by law or regulation. The fact sheet says most in vitro diagnostic tests with the designation should continue to be reviewed by Medicare Administrative Contractors instead.

How the evidence review works

Two steps come before a coverage decision, according to CMS. An Evidence Preview, a focused literature review intended to be done by a contractor, identifies the strengths and weaknesses of the available evidence and any gaps. If a national coverage review is then opened, an evidence summary is posted with the tracking sheet for public comment.

Where gaps exist, the manufacturer writes an Evidence Development Plan to close them. CMS says these plans may use traditional clinical studies or "fit-for-purpose" designs, including studies that rely on secondary use of real-world data, and that CMS and the Agency for Healthcare Research and Quality review them. The non-proprietary parts of an approved plan are published when a proposed decision is posted.

Under the national coverage process, CMS evaluates whether a technology meets the statutory standard of being reasonable and necessary for Medicare beneficiaries, EBR's announcement notes.

A pathway being paused

TCET is closing to newcomers. When CMS and FDA announced a separate pathway called RAPID on April 23, 2026, they said TCET "will be paused for new candidates" while CMS focuses on implementing the new pathway. RAPID aims to issue a proposed national coverage decision on the day FDA authorizes an eligible device. The pause applies to new candidates; the WiSE review was opened in June under TCET.