Clarification of Novitas Timeline

Pacific Edge today wishes to clarify the expected timeline for the finalization or withdrawal of the draft Local Coverage Determination (LCD) and the associated Local Coverage Article (LCA) covering the reimbursement of its Cxbladder tests by Medicare, the US national health insurance provider.

As noted most recently in its FY 23 results announcement, released on 25 May 2023, Pacific Edge stated that its understanding was that Novitas, the Medicare Administrative Contractor with responsibility for its US laboratory, must either finalize or withdraw the proposed LCD (DL 39365) and the associated LCA (DA 59125) that cast Cxbladder’s continued Medicare coverage into doubt, by 28 July 2023 (NZT).

Following further review, and discussions with its advisors and other industry participants, Pacific Edge now understands that Novitas must either finalize or withdraw the proposed LCD and LCA by 9 June 2023 (NZT), 12 months after the original date of posting, not 12 months after date of last revision as previously communicated. We understand that there is no required announcement from Novitas upon passing the expiration date.

Pacific Edge continues to receive coverage for Cxbladder tests, has not been notified by Novitas of any intent to finalize or withdraw and will update the market as soon as we are aware of additional information related to the LCD and LCA.