AUA Micro-Hematuria Guideline and Medicare Timelines

Pacific Edge today notes the American Urological Association (AUA) is seeking urologist feedback on a draft standard of care guideline for the evaluation of microhematuria. The consultation is taking place under strict conditions of non-disclosure with the process commencing after 15 September 2024.  

Pacific Edge also notes the Centers for Medicare & Medicaid Services (CMS) has indicated - through a meeting with stakeholders that included The Coalition for 21st Century Medicine (C21) - that it had agreed to an extension to deliberations on the draft Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365) to ensure Pacific Edge’s Medicare Administrative Contractor, Novitas, had time to respond to a large volume of detailed comments and because the LCD raises unique issues. Novitas confirmed it had been granted an extension to finalize, retire or start over on the draft LCD in late July.

Given these developments Pacific Edge does not expect these matters to be resolved ahead of the company’s Annual Shareholder Meeting (ASM) in Auckland on 24 September 2024, which contrasts to the previous expectations communicated in Pacific Edge’s Q1 24 investor update released to the NZX and ASX on 10 July 2024.

The review of the AUA microhematuria guideline, which was last amended 2020, is potentially significant as guidelines play a substantial role in medical reimbursement policy for Medicare and all other payers. They also have a significant influence over the practices of individual urologists.

Pacific Edge Chief Medical Officer Dr Tamer Aboushwareb is contributing to the AUA’s consultation on the microhematuria guideline. Dr Aboushwareb’s contribution to the process is subject to the terms of the strict and personal AUA confidentiality agreement.

Despite the deliberations over the draft LCD, Pacific Edge continues to receive reimbursement for tests performed for Medicare and Medicaid patients – as it has without interruption since July 2020 including more than two years since the draft LCD was first published. In the event of a total or partial non-coverage determination, reimbursement will continue until at least 45 days after the LCD is publicly notified.

In the Q1 24 investor update Pacific Edge also noted CMS could make a pricing decision on the company’s Cxbladder Detect⁺ test before the ASM on September 24. That remains a possibility. 

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Pacific Edge welcomes you to attend its Annual Shareholder Meeting on Tuesday 24 September. Learn more and RSVP via Eventbrite