Lumos Diagnostics Holdings Ltd has achieved a significant milestone in the commercial rollout of its FebriDx® rapid diagnostic test in the United States, securing reimbursement coverage with two of the seven Medicare Administrative Contractors (MACs). The approved reimbursement rate of US$41.38 per test will take effect from April 2025.
Medicare plays a critical role in the US healthcare reimbursement system, accounting for between 20% and 24% of the national payor mix. Securing MAC-level reimbursement is a key gateway to broader market access, including acceptance by private insurers who often follow Medicare’s lead. Lumos is currently in advanced negotiations with three of the remaining five MACs.
The FebriDx® test, manufactured in the United States, provides rapid, point-of-care results to help clinicians differentiate between bacterial and viral causes of acute respiratory infections in approximately 10 minutes. This timely information supports antimicrobial stewardship by reducing unnecessary antibiotic prescribing.
“It is extremely pleasing to achieve some early wins with two of the seven U.S. Medicare Administrative Contractors. This is an important and critical step in building the reimbursement framework to support clinical adoption for FebriDx®,” Lumos Diagnostics CEO Doug Ward said.
“Manufactured proudly in the United States, FebriDx® is not only addressing a critical clinical need in primary care, urgent care, and emergency medicine, but it is also supporting American jobs and innovation in point-of-care diagnostics. Lumos looks forward to the day that FebriDx® has broad US reimbursement coverage across both public and private insurers and the team is working to deliver on that objective.”
The Company continues to pursue broader reimbursement coverage across the remaining MAC regions and anticipates additional updates as discussions progress.
Lumos advances FebriDx® reimbursement pathway with early Medicare momentum
Lumos continues to make headway in securing broad US reimbursement for its FebriDx® test, following its inclusion in the 2025 Clinical Laboratory Fee Schedule (CLFS) under Proprietary Laboratory Analyses (PLA) Code 0442U, effective 1 January 2025. The test carries a national reimbursement rate of US$41.38 per test, as set by the Centers for Medicare & Medicaid Services (CMS), confirming both its clinical utility and economic viability.
As a critical first step, Lumos obtained the PLA code and associated reimbursement rate from CMS. However, actual payment to healthcare providers requires individual approval by Medicare Administrative Contractors (MACs) and private payors. Lumos has since engaged all seven MACs to drive Medicare coverage, which represents approximately 20%–24% of the US payor mix and often shapes private payor adoption.
From April 2025, FebriDx® has been listed on the Medicare Fee Schedule in both the Palmetto and Novitas regions at the approved rate. Negotiations are also progressing with Noridian, WPS, and CGS MACs, with formal inclusion steps underway.
To support broader coverage, Lumos is actively assisting healthcare providers with claim appeals, offering documentation on medical necessity and gathering clinician feedback. These field activities are expected to underpin adoption and reimbursement growth into 2026.
Importantly, the reimbursement framework currently spans both Moderately Complex and Clinical Laboratory Improvement Amendments (CLIA)-Waived settings. A successful CLIA waiver for FebriDx® would allow seamless use across both environments without duplicating the reimbursement process.
As Medicare adoption accelerates, Lumos anticipates increasing interest from private insurers, reinforcing FebriDx®’s value in supporting clinical decision-making, reducing unnecessary antibiotic use, and improving patient outcomes.