UK regulators recommend iRhythm cardiac arrythmia device - MassDevice

irhythm-logoIRTC) announced that it received a recommendation for adoption from National Institute for Health and Care Excellence (NICE).

San Francisco-based iRhythm said in a news release that it is the first technology to pass through a new digital health tech pilot, resulting in the successful recommendation for adoption from NICE.

The company’s Zio XT service, which is an ambulatory cardiac monitor that uses deep learning algorithms, was positively recommended by NICE as an option for those with suspected cardiac arrhythmias who would benefit from electrocardiograph (ECG) monitoring for more than 24 hours.

NICE’s guidance concluded that Zio XT is “convenient and easy to wear,” while offering greater patient compliance and improved diagnostic yield when compared with standard 24-hour Holter monitoring. Clinical data revealed that patients preferred iRhythm’s technology to current NHS practices, while estimates also suggest that Zio XT is cost-saving or at the very least equal to current practices.

“We are delighted that Zio has received such positive guidance from NICE in this first of its kind evaluation, especially at such a critical time,” iRhythm GM & VP EMEA Justin Hall said in the release. “Throughout the COVID-19 pandemic, we have seen a number of cardiac patients avoiding hospitals and suffering in silence, even when experiencing serious conditions such as strokes. This has led to a backlog of patients requiring care, putting additional pressure on medical staff and services.”

“Fortunately, services like Zio can help ease this backlog, offering clinically-validated services remotely. Patients are not required to expose themselves to high-risk hospital environments, while staff can still offer the same continued level of care. It’s critical, therefore, that patients have access to these technologies and for clinicians to be able to implement them quickly and easily.”

iRhythm also announced today that CMS released a final rule that describes two new code sets related to long-term continuous ECG monitoring and recording, with Category I CPT codes 93241 – 93248 set to replace the current codes iRhythm uses to seek reimbursement for Zio XT.

The company anticipates that the codes, which were established to define the associated time and work for monitoring, detecting and identifying cardiac disease over longer periods of time, will be adopted by all U.S. payors for reporting purposes beginning on Jan. 1, 2021.

In the final rule, CMS did not finalize national pricing for the extended external ECG patch or the medical magnetic tape recorder (SD339) supply. iRhtyhm said in the release that it will be working with medicare administrative contractors to establish pricing for contractor price CPT codes 93241, 93243, 93245 and 93247.

Potentially related to the CMS news, shares of IRTC were down -18.7% at $195.65 per share in mid-morning trading today.

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