Lumos Diagnostics Holdings Ltd has received approval from the Centers for Medicare and Medicaid Services (CMS) Panel for FebriDx’s PLA code to be reimbursed at a rate of US$41.38/test, which the company hopes will help embed the bacterial-viral diagnostic test in the US health system.
The allocation of a unique PLA code to FebriDx is a cornerstone of the test kit’s commercialisation in the US.
"This reimbursement pathway is another important step towards removing barriers to access and potentially benefitting millions of Americans,” said CEO and managing director Doug Ward.
Ease of adoption and access
The PLA code, 0442U, which was issued by the American Medical (TASE:PMCN) Association, will be published on the Clinical Lab Fee Schedule and take effect on January 1, 2025.
This paves the way for the commercial rollout of the FebriDx point-of-care test.
The PLA code allows reimbursement for FebriDx from government and private insurers.
The approval makes FebriDx more accessible and eases its adoption across medical networks with the code and reimbursement expected to facilitate broader use of the test over time, by making it more affordable.
Combatting antibiotic resistance
FebriDx is a rapid test to distinguish between bacterial and non-bacterial infections at the point of care – a critical distinction given that most acute respiratory infections stem from viruses and do not require antibiotics.
Despite this, antibiotics are prescribed in up to 50% of such cases, contributing to the growing issue of antibiotic resistance.
The US faces particular challenges in this area, with antibiotic resistance leading to some 2.8 million illnesses and 35,000 deaths annually.
What’s next?
Next (LON:NXT) up for Lumos is to engage with US private and government payers, as well as other key stakeholders, to establish reimbursement and coverage policies.
The company will also progress its plans to implement FebriDx in clinical pathways and triage workflows and work to achieve CLIA waiver labelling.