Key Highlights

  • AVITA Medical reported third-quarter Revenue of US$26.1 million, up 53%, and raised 2026 revenue guidance to US$92 million to US$94 million.
  • Epiminder said CMS set a 2027 national payment rate of US$31,265 for the Minder System implant procedure, up 13%.
  • Pacific Edge said the final Medicare LCD confirms coverage for Cxbladder Triage and Triage Plus, effective 20 December 2026.
  • The three updates all relate to reimbursement or payment decisions published in early November 2026.

Reimbursement decisions in the United States featured in updates from three healthcare companies listed on the ASX. AVITA Medical (ASX:AVH), Epiminder (ASX:EPI) and Pacific Edge (ASX:PEB) each described developments linked to the Centers for Medicare & Medicaid Services.

AVITA Medical Reports Third-Quarter Results

AVITA Medical reported total revenue of US$26.1 million for the quarter ended 30 September 2026, up 53% year on year and 20% sequentially. RECELL generated US$22.4 million of US revenue, Cohealyx contributed US$2.1 million and PermeaDerm US$0.6 million. Gross Margin was 84.0%, up 270 basis points, and operating expenses were US$24.6 million. The net loss narrowed to US$6.2 million, or US$0.20 per share, from US$13.2 million a year earlier.

Net cash use improved to about US$0.6 million from US$3.2 million in the second quarter, and cash and marketable securities totalled about US$10.5 million. The company raised 2026 revenue guidance to US$92 million to US$94 million from US$86 million to US$89 million, reaffirmed an expectation of Cash Flow breakeven in the fourth quarter, and drew a further US$10 million under its Perceptive Advisors Credit Facility after meeting a trailing revenue milestone. The going-concern qualification was removed in its Form 10-Q. CMS also finalised national physician payment values and simplified billing codes for RECELL procedures, effective 1 January 2027.

RECELL product gross margin was 88.4% and is expected to stay between 86% and 90%. The company receives 50% of the average sales price for Cohealyx and up to 55% for PermeaDerm, which lowers the blended margin. The new guidance implies fourth-quarter revenue of US$24.9 million to US$26.9 million. PermeaDerm I met its primary endpoint, showing comparable outcomes to allograft with 70% lower product cost and 95.7% less preparation time.

Epiminder Receives a Higher Payment Rate

Epiminder said CMS finalised its CY2027 Hospital Outpatient Prospective Payment System rule, assigning the Minder System implant procedure to Ambulatory Payment Classification 5117 with a national rate of US$31,265. This compares with US$27,700 in 2026, an increase of 13%, and takes effect on 1 January 2027. The payment covers the hospital's costs, including the implanted device, and is adjusted for local wage levels.

The decision follows an expanded paediatric clearance from the FDA issued the previous week and enrolment of the 100th participant in the DETECT study in mid-October. The company expects to reach 125 participants by December 2026. Chief Executive Rohan Hoare said the rate gives hospitals a defined basis for evaluating the device as the company plans to expand access across US epilepsy centres in 2027.

Pacific Edge Confirms Medicare Coverage

Pacific Edge said the final Local Coverage Determination for urine-based biomarkers in microhematuria patients, L40378, has been published and takes effect on 20 December 2026. Cxbladder Triage and Triage Plus are covered for intermediate-risk patients, a group representing about 1.14 million testing opportunities a year by management estimate. Competing tests and generic billing codes are non-covered under the determination.

The company cited recent PAMA pricing of US$1,057 per test for Triage, US$1,026 for Monitor and US$1,328 for Triage Plus. Commercially contracted lives for its hematuria tests total 12.9 million in addition to Medicare, which covers more than 71 million lives. Pacific Edge said it is making selective investments in its commercial team and digital technologies.

The final determination closely resembles the draft published in May 2026. Pacific Edge said Geisinger, owned by Kaiser Permanente, recently set a commercial policy for all-risk microhematuria patients, and it expects Medicare Advantage payers to reimburse in line with Medicare policy. The company also plans to use the coverage decision in discussions with commercial payers, which collectively insure about 223 million lives.

A Common Thread

Each announcement links a clinical or commercial product to a defined US payment framework. The effective dates fall between 20 December 2026 and 1 January 2027, and the companies indicated that their commercial plans for 2027 will be shaped by how those frameworks are applied in practice.