EBR Systems Wins Maximum $41,145 NTAP Reimbursement for WiSE System
EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.
- CMS grants NTAP reimbursement for WiSE System at maximum rate
- Reimbursement adds up to $41,145 on top of standard Medicare payments
- NTAP coverage effective for three years from October 1, 2025
- Supports EBR’s initial limited market release and commercialisation strategy
- Pending final approval for outpatient Transitional Pass-Through payments
A Milestone in Cardiac Care Reimbursement
EBR Systems, a Silicon Valley-based medical device innovator, has achieved a significant regulatory milestone with the U.S. Centers for Medicare & Medicaid Services (CMS) confirming final approval for New Technology Add-On Payment (NTAP) reimbursement for its WiSE cardiac resynchronisation therapy (CRT) system. This approval, effective from October 1, 2025, marks a critical step in bridging the financial gap for hospitals adopting this cutting-edge wireless pacing technology.
The NTAP program is designed to encourage early adoption of breakthrough medical devices by supplementing the standard Diagnosis Related Groups (DRG) payments that Medicare provides for inpatient procedures. For EBR’s WiSE System, CMS has approved the maximum NTAP reimbursement rate of up to US$41,145, based on an average device selling price of US$63,300. This payment is in addition to the usual DRG payments, which cover other procedural and device costs.
Commercial Implications and Market Entry
This reimbursement approval aligns with EBR’s commercialisation strategy, enabling the company to launch a limited market release of the WiSE System concurrently with the start of NTAP coverage. The financial support from Medicare is expected to accelerate hospital adoption by alleviating cost concerns, thereby expanding patient access to this novel wireless cardiac pacing technology.
John McCutcheon, EBR’s CEO, highlighted the importance of this milestone, noting that NTAP reimbursement not only addresses payment gaps but also enhances the commercial attractiveness of the WiSE System. The technology itself represents a leap forward in cardiac care by eliminating the need for traditional pacing leads, which have historically been a source of complications and reliability issues.
Looking Ahead – Reimbursement and Regulatory Pathways
The NTAP reimbursement will remain in effect for three years, during which CMS will collect real-world cost data from Medicare claims. EBR plans to petition CMS in the second year to transition WiSE procedures into a DRG category that fully covers the device and procedural costs, aiming for sustainable reimbursement beyond the NTAP period.
Additionally, EBR is awaiting final approval for Transitional Pass-Through (TPT) payments for outpatient settings, which CMS has preliminarily recommended. Securing TPT reimbursement would further broaden the WiSE System’s market potential by facilitating outpatient procedures.
Overall, this CMS approval represents a pivotal moment for EBR Systems, validating the clinical and economic value of its wireless cardiac pacing technology and setting the stage for broader adoption in the U.S. healthcare system.
Bottom Line?
With NTAP reimbursement secured, EBR Systems is poised to transform cardiac pacing adoption; but the next reimbursement phase will be critical.
Questions in the middle?
- Will EBR successfully transition WiSE procedures to full DRG coverage after the NTAP period?
- How quickly will hospitals adopt the WiSE System given the new reimbursement incentives?
- What impact will outpatient TPT approval have on the device’s market penetration?
