Medicare Coverage for Bladder Cancer Tests Faces Uncertainty Amid Novitas Review

Medicare Coverage Review Initiated

Pacific Edge, a global leader in bladder cancer diagnostics, has announced that Novitas, a Medicare Administrative Contractor, intends to convene an expert panel in early 2026. This panel, known as a Contractor Advisory Committee (CAC), will evaluate coverage for diagnostic tests referenced in the 2025 update to the American Urological Association (AUA) microhematuria guideline, including Pacific Edge’s flagship Cxbladder Triage test.

The formation of this panel signals a significant step in the potential revision of Medicare policy. CAC meetings typically precede the drafting of new or substantially revised Local Coverage Determinations (LCDs), which dictate reimbursement policies for Medicare beneficiaries. Aligning Medicare coverage with the latest clinical guidelines could enhance access to innovative diagnostic tools for patients presenting with microhematuria, a condition characterized by blood in the urine that can be an early indicator of bladder cancer.

Clinical Evidence Driving Policy Consideration

Pacific Edge’s CEO, Dr Peter Meintjes, highlighted the importance of the AUA guideline update and the role of robust clinical evidence in shaping medical policy. The company’s STRATA study, a multicenter prospective randomized controlled trial comparing Cxbladder Triage to cystoscopy, has been instrumental in demonstrating the test’s clinical utility. Published in The Journal of Urology in July 2024, this trial supports the inclusion of Cxbladder Triage in the updated guideline and underscores its potential to improve patient outcomes while optimizing clinical workflow.

Cxbladder is a non-invasive genomic urine test designed to stratify risk in patients with microhematuria and those under surveillance for recurrent bladder cancer. With over 20 years of research and more than 25 peer-reviewed publications backing its efficacy, the test is already widely used across the US, Australasia, Israel, and parts of Asia and South America. In the US alone, over 5,000 urologists have ordered more than 130,000 tests, reflecting growing clinical acceptance.

Implications for Pacific Edge and Medicare Beneficiaries

The Novitas panel’s review could lead to a revised Medicare LCD that formally incorporates the 2025 AUA guideline recommendations, potentially expanding reimbursement for Cxbladder Triage. This would be a meaningful development for Pacific Edge, as Medicare coverage is a critical factor influencing test adoption and revenue growth in the US market.

For patients, updated Medicare policy aligned with the latest clinical guidelines could mean improved access to less invasive, more accurate diagnostic options. This aligns with broader healthcare goals of enhancing patient experience and optimizing resource allocation in urology practices.

While the panel’s convening is a positive signal, the final outcomes and timing of any policy changes remain uncertain. Stakeholders will be watching closely as the CAC deliberates and as Novitas moves toward issuing a draft LCD.