• EBR submits New Technology Add-On Payment (NTAP) application for its WiSE CRT System to the Centers for Medicare & Medicaid Services (CMS) in US
  • Application is a key milestone in EBR’s strategy to achieve US reimbursement and reduce costs of WiSE for patients
  • EBR is confident with its FDA breakthrough device designation WiSE will meet criteria for NTAP

 

EBR Systems (ASX:EBR) has announced a key milestone in its strategy to achieve US reimbursement for its WiSE CRT System, which holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.

The company has submitted a New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services (CMS) for WiSE.

EBR said the NTAP was designed to bridge the financial gap between costs of innovative technologies and the standard Medicare Severity Diagnosis Related Groups (MS-DRG) payment structure, encouraging early adoption of breakthrough medical advancements used in inpatient settings for Medicare patients.

The company said three specific criteria apply including:

  • Newness – The medical service or technology must be new
  • Cost – The medical service or technology must be sufficiently priced so that the standard MS-DRG rate otherwise applicable is determined inadequate
  • Substantial Clinical Improvement – The medical service or technology must demonstrate a substantial clinical improvement over existing services or technologies

EBR said FDA breakthrough device designation ensures that the WiSE CRT System automatically met the newness and substantial clinical improvement criteria.

EBR said it was confident the cost criterion would be met based on its pricing strategy for the WiSE CRT System.

 

Reducing costs for patients

EBR said the submission marked a significant milestone in EBR’s commercialisation strategy to achieve US reimbursement, supporting patient access to its unique technology and accelerating adoption in the US market.

EBR said achieving NTAP designation would enable reimbursement for in-patient procedures for Medicare patients. The Company will also seek additional reimbursement for Medicare outpatients when it receives FDA approval.

NTAP payments are limited to the lesser of 65% of the technology’s costs or 65% of the amount by which case costs exceed the standard MS-DRG payment.

EBR said this reimbursement would significantly reduce financial barriers for patients. The company said it would support EBR’s commercialisation strategy by improving patient access and accelerating market adoption in the US.

The company recently announced the FDA had accepted its final premarket approval (PMA) application for the WiSE CRT System.

EBR is anticipating receiving FDA approval for the WiSE CRT System in Q1 2025, ahead of CMS’s May 1, 2025 deadline.

The company said this would enable NTAP coverage to take effect from October 2025, the start of CMS’s FY26.

 

‘Significant milestone in the final regulatory phase’

EBR president and CEO John McCutcheon said submission of the NTAP application to CMS marked a significant milestone in the final regulatory phase as the company moved toward FDA approval early next year.

“This achievement brings us closer to delivering our unique technology to patients in need,” he said.

“We remain focused on executing our broader commercialisation strategy to accelerate market adoption and ensure widespread access in 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.

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