EBR Systems applies for cardiac device reimbursement for outpatients

Having already received a recommendation for inpatients from the CMS, EBR is now applying for reimbursement for its WISE CRT System for outpatients under the same criteria.

If EBR’s TPT reimbursement programs are approved, it will allow both outpatients and inpatients to receive enhanced Medicare payments for up to 2-3 years. Pic: Getty Images.

• EBR Systems has applied for a Transitional Pass-Through (TPT) reimbursement scheme for its WISE CRT System through the US Centers for Medicare & Medicaid Services (CMS)

• The application is for outpatients, following on from a recommendation from the CMS that inpatients be eligible for the New Technology Add-On Payment

• The criteria are the same for both schemes, giving EBR high confidence they will be approved.

Special Report: EBR Systems has applied to the US Centers for Medicare & Medicaid Services (CMS) for the Transitional Pass-Through (TPT) reimbursement scheme for the WISE CRT System for outpatients.

EBR Systems (ASX:EBR) is confident its outpatient application will be well received by the CMS, as the organisation has already recommended EBR’s WISE CRT System for reimbursement under the New Technology Add-On Payment scheme for inpatients.

As both applications fall under the same criteria, the company is confident it will be accepted for both schemes, which become effective from October 1, 2025 should they be approved.

The TPT reimbursement program is designed to facilitate hospital adoption of breakthrough medical technologies – especially those that demonstrate substantial improvements for patients – whose costs are not fully incorporated into standard Medicare repayment rates.

The WISE CRT System

EBR’s WISE CRT System is the world’s only wireless endocardial (placed within the heart) pacing system in clinical use for stimulating the heart’s left ventricle.

Internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location that has long been a goal of cardiac pacing companies.

The cardiac implant is roughly the size of a large grain of rice and has potentially eliminated the need for a pacing wire on the outside of the heart’s left ventricle along with the accompanying complications from an external wire.

Said complications can occur during insertion, use or removal and can include infection, myocardial damage, perforation, fluid accumulation and disruption of coronary connections or openings.

Future products could potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.

The device is an investigational device in most markets, currently only available for sale in the US.

Enhanced financial support

The TPT program provides a clear reimbursement pathway for medical systems like EBR’s WISE, enabling enhanced Medicare payments for up to 2-3 years to support the commercial rollout of the technology.

EBR president and CEO John McCutcheon said the application submission marks another major milestone in the company’s path to securing broad patient access for WISE in the US.

“We are committed to ensuring that hospitals and clinicians have the financial support needed to deliver our innovative therapy to heart failure patients,” McCutcheon said.

“Securing the TPT reimbursement scheme will provide a clear reimbursement pathway to hospitals, supporting our sales team’s efforts across the US.”

This article was developed in collaboration with EBR Systems, a Stockhead advertiser at the time of publishing. 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as EBR Systems applies for cardiac device reimbursement for outpatients