Resonance Health Ltd announces the development of its newest AI medical device, LiverSmart, which is now undergoing final quality and verification checks prior to its submission to the United States Food & Drug Administration (FDA) for regulatory clearance.
LiverSmart combines two existing regulatory-cleared Resonance Health products, FerriSmart® and HepaFat-AI®, into a single multi-parametric MRI session, avoiding the need for multiple MRI appointments, and delivering a more complete and comprehensive assessment of a person’s liver.
Instead of obtaining individual FerriSmart® and HepaFat-AI® reports via separate scanner sessions, which adds to cost and inconvenience, patients and clinicians will soon be able to obtain both analyses at the same time with one referral, and in one consolidated report. Clinicians seeking both analyses will simply refer for a LiverSmart assessment, by Resonance Health.
LiverSmart’s use remains subject to regulatory clearances including with the US FDA which is expected to take approximately 45 days from submission, or longer if the FDA have queries. LiverSmart is currently undergoing final quality and verification checks and the Company anticipates being in a position to submit LiverSmart’s application for FDA clearance within the coming weeks. The Company’s AI, technical, quality assurance, and regulatory personnel, are focused on achieving this by the end of 2021, and potentially in time for featuring at the RSNA conference in Chicago in early December 2021.
New CPT Codes & Reimbursement
Importantly, the Company believes that LiverSmart may be eligible for two new United States (Category III) Current Procedural Technology (CPT) codes recently published by the American Medical Association (AMA) and which become active on 1 January 2022. The Company is awaiting definitive determination of LiverSmart’s eligibility for these codes, from a US certified CPT coder.
CPT codes are a national procedural coding set maintained by the AMA, and recognised by US government agencies, used to describe medical services for reimbursement by both government payers such as Medicare, Medicaid, and private payers including private health insurers. The codes are used by physicians and health care professionals for reporting and tracking medical services performed by healthcare providers.
CPT codes start as temporary Category III codes and, when there is sufficient reporting of the codes over a period, they are upgraded to Category I, at which point they become permanent and reimbursable. Assuming LiverSmart is eligible for the new codes, hospitals and MRI imaging centres will be able to use the codes when using LiverSmart for clinical purposes and the service will be systematically tracked through the US healthcare system, which is a critical element of demonstrating the clinical need for the service in the US.
If the codes, which become active on 1 January 2022, are confirmed as applicable to LiverSmart it will be another milestone in the pathway to widespread payer and insurer reimbursement in the US and will better facilitate LiverSmart being reimbursed by private payers such as private health insurers, as well as Medicare and Medicaid.
Managing Director Comment
Managing Director of Resonance Health, Mitchell Wells, said the following:
“LiverSmart is an evolution of our existing product offering and it responds to the growing trend in medical imaging for more holistic assessment of human organs using AI for rapid turnaround and enhanced scalability.
The LiverSmart device focusses on our core expertise in the liver and it leverages our global standing in liver-iron and liver-fat assessment through our existing regulatory-cleared liver products. LiverSmart provides a more complete assessment of the liver by combining multiple MRI appointments and assessments into a singular multi-parametric scanning session which will enhance patient convenience and should reduce cost.
Importantly, we believe that LiverSmart may be eligible for two new United States (Category III) CPT Codes, and we are now awaiting a definitive determination from a US code certifier. If the codes are determined to be applicable to LiverSmart this will represent a major milestone on our pathway to more widespread reimbursement in the USA.”