Latest Medicare Coverage News

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.

Pacific Edge announces a two-month delay in the Medicare Local Coverage Determination for its genetic oncology tests, extending the effective date to April 24, 2025. This extension follows the company’s active engagement with US regulatory bodies.

Pacific Edge reports stable test volumes in Q3 FY25 despite Medicare reimbursement uncertainties and seasonal slowdowns, while gearing up for legal action against a flawed Medicare coverage decision.

Pacific Edge faces a significant Medicare reimbursement setback as Novitas finalizes a non-coverage decision for its Cxbladder tests, prompting the company to activate legal challenges and operational restructuring.