Pacific Edge (ASX:PEB) has confirmed that the final Local Coverage Determination (LCD) for urine-based biomarkers in patients with microhematuria has been published to the Medicare Coverage Database, establishing Medicare coverage for its Cxbladder Triage and Triage Plus tests, with the determination scheduled to become effective on 20 December 2026.

Key Points

  • Final LCD (L40378) confirms Medicare coverage for Cxbladder Triage and Triage Plus for intermediate-risk microhematuria patients, representing approximately 1.14 million testing opportunities per year
  • Competing tests and generic billing codes are non-covered under the final LCD
  • Triage and Monitor are priced at US$1,057/test and US$1,026/test respectively under PAMA, with Triage Plus priced at US$1,328/test
  • Geisinger, owned by Kaiser Permanente, has recently established commercial policy for all-risk microhematuria patients, bringing commercially contracted lives for hematuria tests to 12.9 million

Final LCD Details and Effective Date

The final LCD, titled "Urine-based Biomarkers in Patients with Microhematuria" (L40378), establishes hematuria evaluation as a covered Medicare benefit and provides foundational medical policy for the use of validated urine-based biomarkers in the evaluation of intermediate-risk microhematuria patients. The determination is scheduled to become effective in 45 days on 20 December 2026. According to the filing, the final LCD substantially resembles the draft LCD published in May 2026. Medicare covers more than 71 million lives in the United States.

Pricing and Commercial Payer Coverage

Cxbladder Triage and Monitor were recently re-priced under the Protecting Access to Medicare Act (PAMA) at US$1,057/test and US$1,026/test respectively, with Triage Plus priced at US$1,328/test. The company said its key focus remains migrating all hematuria evaluation testing to Triage Plus, focusing on intermediate-risk patients, implementing clinical pathways at integrated delivery networks, and improving average selling price through commercial payer activities. Pacific Edge expects Medicare Advantage payers to reimburse for Triage and Triage Plus in accordance with Medicare policy. US commercial payers collectively insure approximately 223 million lives.

Chief Executive Commentary and Commercial Strategy

Pacific Edge Chief Executive Dr Peter Meintjes described the final LCD as a significant milestone for Medicare patients, urologists, and the broader healthcare system. Dr Meintjes said the LCD confirms Pacific Edge as the market leader, with only Triage and Triage Plus tests covered under the policy. He added the company is making selective investments in its commercial team and digital technologies to support commercial and laboratory operations. The filing states Pacific Edge expects the final policy to provide a reference point for US commercial payers as they consider their own medical policies for urine-based biomarkers in microhematuria evaluation.