Medicare Coverage Decision Looms After Strong Support for Non-Invasive Bladder Cancer Tests
A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.
- Clear expert support for urine-based biomarkers in hematuria evaluation
- Endorsement of Cxbladder Triage and Triage Plus for Medicare coverage
- Panel highlights non-invasive alternatives to cystoscopy
- Potential to improve access in rural areas and reduce invasive procedures
- Novitas to consider policy development with draft coverage expected within six months
Expert Panel Endorses Urine-Based Biomarkers
Pacific Edge, a cancer diagnostics company headquartered in New Zealand, has received a significant boost from a recent Contractor Advisory Committee (CAC) meeting organized by Novitas, the Medicare Administrative Contractor overseeing its US laboratory operations. The panel of urologists and pathologists expressed clear support for the use of urine-based biomarker tests, specifically Pacific Edge’s Cxbladder Triage and Triage Plus, in the evaluation of hematuria; a key symptom that can indicate bladder cancer.
The panel’s consensus was that these tests are medically reasonable and necessary, recommending their inclusion for Medicare coverage. This endorsement is grounded in strong clinical evidence, including pivotal studies like STRATA, the first randomised control trial of a urine biomarker, and the Kaiser Study, the largest real-world comparative analysis.
Broad Clinical Utility and Patient Benefits
Panelists highlighted the versatility of these biomarkers across all risk categories of hematuria, including microhematuria and select cases of gross hematuria. They noted the tests’ potential to serve as non-invasive alternatives to cystoscopy, especially valuable for patients reluctant to undergo invasive procedures. The biomarkers also offer utility as reflexive or adjunctive tools when traditional methods like cystoscopy or cytology yield inconclusive results.
Importantly, the panel underscored the logistical and economic advantages of urine-based testing, particularly in primary care settings. This is critical for improving healthcare access in rural areas, where 63% of counties lack urological services. By prioritising referrals for higher-risk patients and enhancing early detection, these tests could reduce the incidence of muscle-invasive bladder cancer, which is more difficult and costly to treat.
Pathway to Medicare Coverage
Novitas will use the panel’s feedback, alongside published evidence and the updated 2025 American Urological Association (AUA) Microhematuria Guideline, to determine whether to develop a Local Coverage Determination (LCD) policy supporting reimbursement for Cxbladder tests. Pacific Edge estimates a draft LCD could be published within six months, with final coverage potentially effective within a year.
Pacific Edge’s Chief Executive Dr Peter Meintjes expressed optimism about the panel’s endorsement, describing the meeting as constructive and evidence-driven. He emphasised the clinical need and the potential for these biomarkers to transform hematuria management, improving patient outcomes and healthcare efficiency.
Looking Ahead
The expert panel’s strong backing marks a pivotal moment for Pacific Edge, potentially unlocking broader Medicare access and accelerating adoption of non-invasive bladder cancer diagnostics. However, the final reimbursement decision rests with Novitas, and the company will need to continue demonstrating clinical utility and navigating regulatory processes to realise the full market opportunity.
Bottom Line?
With expert endorsement in hand, Pacific Edge awaits Medicare’s next move that could redefine bladder cancer diagnostics.
Questions in the middle?
- When exactly will Novitas publish its draft Local Coverage Determination for Cxbladder tests?
- How will Medicare reimbursement rates impact Pacific Edge’s US market penetration?
- What barriers remain for widespread adoption of urine-based biomarkers in primary care?
