Latest Medicare Coverage News

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

Pacific Edge has successfully raised NZ$16 million through an upsized equity placement, surpassing its initial target and setting the stage for a planned NZ$5 million Share Purchase Plan. The funds aim to accelerate clinical and commercial milestones, including regaining Medicare coverage for its cancer diagnostic tests.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Pacific Edge Limited reported a resilient FY25 performance despite losing Medicare coverage for its Cxbladder tests in the US, announcing a $20 million equity raise to support commercialization and growth.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a fifth contractor, covering more than 70% of US Medicare payments and advancing its commercial reach.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.

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.