CMS Recommends US$1,328 Price for Triage Plus

Pacific Edge notes today that the recommended final ‘Gapfill’ price for Cxbladder Triage Plus¹ has been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price – a higher price than the US$1,018 draft price proposed in April this year.

The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance for Triage Plus subject to Pacific Edge’s Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas’ ‘Genetic Testing in Oncology: Specific Tests (L39365)’ Local Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration request for Triage Plus shortly after the publication of the DRIVE Study² that is currently in peer review.

Hematuria evaluation tests currently represent around 83% of Pacific Edge’s total US laboratory throughput³. The US$1,328.32 price is a meaningful increase compared to the US$760 CMS price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since the February 2025 inclusion of Triage in the American Urological Association’s microhematuria guideline.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are very pleased that MolDX has recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32 and that CMS has recommended this as a final price. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.

“The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus’ performance characteristics⁴ are used in our existing budget impact model⁵ we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.”

The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is typically not expected to change, and is expected to become effective from 1 January 2026.

¹ Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+.

² Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.

³ Half year to 30 September 2024.

⁴ Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126.

⁵ Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.