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HIGHLIGHTS
- EBR Systems has submitted an application for New Technology Add-On Payment (NTAP) to the Centers for Medicare & Medicaid Services (CMS) for its WiSE CRT System.
- To qualify for NTAP, technologies must meet three criteria: being new, having costs that exceed standard Medicare payments, and demonstrating substantial clinical improvement over existing options.
- EBR expects FDA approval for the WiSE CRT System by Q1 2025, which would allow for NTAP coverage to become effective from October 2025.
EBR Systems, Inc. (ASX:EBR), developer of the world’s first wireless cardiac pacing device for heart failure, has submitted a New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services (CMS) for its WiSE CRT System. This system represents a groundbreaking advancement in cardiac pacing technology and has the potential to transform heart failure treatments.
The NTAP program is designed to assist in covering the cost of new, innovative medical technologies not fully reimbursed under the traditional Medicare Severity Diagnosis Related Groups (MS-DRG) payment system. This ensures that pioneering medical advancements are accessible to Medicare patients, while incentivizing hospitals to adopt these technologies early.
Key NTAP Criteria
To qualify for NTAP, three essential criteria must be met:
- Newness: The technology must be novel and recently introduced.
- Cost: The pricing must be high enough that standard MS-DRG payments are insufficient to cover it.
- Substantial Clinical Improvement: The technology must show significant clinical benefits over existing alternatives.
Due to its FDA breakthrough device designation, the WiSE CRT System already satisfies the "Newness" and "Substantial Clinical Improvement" requirements. EBR is confident that the Cost criterion will also be met, given its anticipated pricing strategy.
NTAP Benefits for WiSE CRT System
If NTAP designation is achieved, it will provide hospitals with additional reimbursement for in-patient procedures involving the WiSE CRT System in Medicare patients. The NTAP payment would cover the lesser of 65% of the technology’s cost or 65% of the amount by which the case costs exceed the standard MS-DRG payment. This would help alleviate the financial burden on patients and healthcare providers, facilitating faster adoption of the WiSE CRT System across the U.S.
FDA Approval and Market Launch
EBR anticipates receiving FDA approval for the WiSE CRT System by Q1 2025, ahead of the CMS submission deadline of May 1, 2025. This would make the NTAP coverage effective from October 2025, aligning with the start of CMS’s FY2026.
This strategic move supports EBR's commercial ambitions by improving patient access to this innovative technology, ultimately accelerating its market adoption in the U.S.
