EBR gains key US reimbursement for WiSE cardiac device

• US Centers for Medicare & Medicaid Services approves EBR’s WiSE CRT System for Medicare inpatients under new technology add-on payment
• Payments will be provided in addition to standard Diagnosis Related Groups payments for the procedure
• Reimbursement to start on October 1, coinciding with EBR’s initial limited market release of WiSE CRT system for heart failure

Special Report: EBR Systems has achieved a major milestone in the US commercialisation strategy of its WiSE CRT system, with key reimbursement for the world’s only wireless cardiac pacing device for heart failure.

The US Centers for Medicare & Medicaid Services (CMS) has granted new technology add-on payment (NTAP) approval for EBR Systems’ (ASX:EBR) WiSE CRT System, which received US Food and Drug Administration approval in April.

The NTAP program is designed to offset the cost of innovative medical technologies beyond the standard Diagnosis Related Groups (DRG) payment structure, encouraging early adoption of breakthrough devices for Medicare inpatients.

Under the approval, hospitals will receive the maximum reimbursement rate of up to US$41,145 per procedure, based on an average WiSE selling price of US$63,300.

This is in addition to existing DRG payments that cover procedure and remaining device costs.

NTAP reimbursement will remain in place for three years while CMS collects actual costs for the device and procedure based on Medicare claims data.

EBR said during the second year it intends to petition for WiSE procedures to be assigned to a DRG that fully reflects system and procedural costs.

The reimbursement will start on October 1, aligning with EBR’s planned limited market release of the WiSE CRT system.

The company also expects to secure transitional pass-through (TPT) payment approval for outpatient use before the same date, with CMS already recommending approval subject to a final ruling.

Watch: Commercial progress for WISE CRT 

‘Enhances the commercial attractiveness of our product’

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 and 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  need for a pacing wire on the outside of the heart’s left ventricle along with the accompanying complications from an external wire.

President and CEO John McCutcheon said EBR was thrilled that the WiSE System had received NTAP reimbursement approval.

“The NTAP program supports innovative technologies by addressing gaps in existing DRG payments, ensuring that hospitals can adopt important, cutting-edge solutions.

“This milestone enhances the commercial attractiveness of our product, accelerates hospital adoption, and expands patient access to our groundbreaking cardiac pacing technology 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.