Latest Medicare Reimbursement News

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

4DMedical has won a crucial US Medicare reimbursement for its CT, VQ™ lung imaging software, paving the way for rapid adoption across American hospitals. This milestone follows FDA clearance and promises to transform lung diagnostics with safer, faster scans.

PolyNovo Limited stands to benefit from proposed U.S. Medicare changes that introduce a flat reimbursement rate for outpatient wound care skin substitutes, potentially reshaping the competitive landscape in favour of cost-effective, clinically proven products.

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

AVITA Medical’s Q2 2025 update reveals a temporary setback in RECELL demand due to Medicare reimbursement delays, offset by strong revenue growth and promising clinical data. The company anticipates recovery and renewed growth in the second half of the year.

AVITA Medical reported a 21% increase in Q2 commercial revenue to $18.4 million and narrowed its net loss, yet faces a reimbursement hurdle that forced a downward revision of full-year guidance. The company highlights clinical progress and strategic board appointments as it navigates payment challenges.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for TR987® despite patient recruitment hurdles, while TR Pro+® sales surge and new distribution deals pave the way for international growth.

Nova Eye Medical has reported a record A$29.2 million revenue for FY25, driven by strong sales growth and improved profitability in its glaucoma segment. The company targets breakeven EBITDA in the first half of FY26 amid promising regulatory and market developments.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.

Pacific Edge reports steady demand for its Cxbladder cancer diagnostic tests despite losing Medicare coverage and transitioning US customers to a new test. The company is advancing clinical evidence and a $21 million capital raise to support growth and regain coverage.