Latest Medicare Coverage News

PolyNovo Limited reported a robust 25.2% increase in half-year revenue to A$75 million, driven by strong U.S. sales and product growth, despite a near break-even net profit impacted by a manufacturing slowdown and a fire at its R&D lab.

Pacific Edge reports a 13.4% decline in test volumes for Q3 2026 but gains strategic momentum with a key Medicare advisory meeting and clinical endorsements poised to influence reimbursement policy.

PolyNovo reports a robust 26% increase in group sales for 1H FY26, driven by strong U.S. market expansion and a near tripling of NovoSorb MTX sales. The company also completes a new manufacturing facility, positioning itself for sustained growth.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

Pacific Edge reports a 9% decline in Cxbladder test volumes amid Medicare coverage loss but gains momentum with new clinical validation and a CMS pricing boost.

EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

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.

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 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.