Pacific Edge’s Cxbladder Plus and Triage 1 Draft Medicare Prices Set at $1,018 and $1,588
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.
- CMS proposes draft 'Gapfill' prices: US$1,018.44 for Cxbladder Plus, US$1,587.69 for Triage 1
- Proposed prices represent substantial increases over current Medicare reimbursement
- Pricing subject to public comment until June 28, 2025, with expected implementation January 2026
- Triage Plus included in American Urological Association’s microhematuria guideline
- Pacific Edge plans to submit reconsideration request for Triage coverage soon
Medicare’s Draft Pricing Boosts Pacific Edge’s US Diagnostics
Pacific Edge (ASX: PEB) has received a promising signal from the US Centers for Medicare & Medicaid Services (CMS) with the publication of draft 'Gapfill' reimbursement prices for its flagship diagnostic tests, Cxbladder Plus and Triage 1. The proposed prices, US$1,018.44 for Cxbladder Plus and US$1,587.69 for Triage 1, mark a significant uplift from previous Medicare reimbursement levels, potentially enhancing the commercial viability of these tests in the critical US healthcare market.
The draft pricing, published by Novitas and MolDX, the Medicare Administrative Contractors responsible for pricing and coverage decisions, reflects a recognition of the advanced multimodal nature of Triage Plus, which integrates DNA and RNA analysis with algorithmic outputs to stratify risk in patients presenting with hematuria. This complex testing approach justifies the higher reimbursement, according to Pacific Edge’s executive commentary.
Clinical Validation and Guideline Inclusion Strengthen Position
Triage Plus’s inclusion in the American Urological Association’s microhematuria guideline underscores its growing clinical acceptance. Pacific Edge has published analytical and clinical validation studies supporting the test’s performance, which aims to reduce unnecessary invasive procedures and better allocate clinical resources. The company highlights that hematuria-related tests represent approximately 81% of its US laboratory throughput, making the pricing update particularly impactful.
While the draft prices are subject to a public comment period ending June 28, 2025, and potential adjustments before finalisation, the proposed reimbursement rates are expected to take effect from January 1, 2026. This timeline allows Pacific Edge to prepare for broader market adoption and operational scaling in the US.
Strategic Implications and Next Steps
Pacific Edge plans to submit a reconsideration request for Triage coverage shortly, aiming to secure formal Medicare coverage and administrative coding updates. The company’s leadership expressed optimism that the pricing reflects recognition of the substantial resources invested in developing and validating these tests, which combine genomic insights with clinical workflows to improve patient management.
The pricing update also signals a potential margin improvement for Pacific Edge’s US operations, as the new rates represent a meaningful increase over the existing US$760 per test reimbursement. This could translate into enhanced profitability and support for ongoing research and commercialization efforts.
Overall, the CMS draft pricing proposal represents a pivotal moment for Pacific Edge, reinforcing its position in the competitive bladder cancer diagnostics space and setting the stage for expanded Medicare coverage and adoption.
Bottom Line?
As CMS finalises pricing, Pacific Edge stands poised to deepen its US market foothold with improved Medicare reimbursement.
Questions in the middle?
- Will CMS maintain or adjust the proposed draft prices after the public comment period?
- How quickly can Pacific Edge secure full Medicare coverage and administrative coding for Triage Plus?
- What financial impact will the new reimbursement rates have on Pacific Edge’s US revenue and profitability?