Pacific Edge Welcomes Stay of Novitas LCD

Pacific Edge Welcomes Stay of Novitas LCD

Pacific Edge today welcomes a decision from Novitas1 and First Coast to delay the implementation of the Local Coverage Determination (LCD, L35396) released in early June that would have seen Medicare coverage of Cxbladder cease in the US on 17 July 2023.

In an email received by Pacific Edge from our US lawyers, the US Department of Health and Human Services Associate General Counsel Janice L Hoffman said: "Details are being worked out but there is a commitment from these two MACs (same parent company) that the LCD will not proceed as is and that the LCD will go through the LCD process again with an open meeting and public comment period”.

No time frame has been provided for the process.

Pacific Edge Chief Executive Dr Meintjes said Pacific Edge was pleased with the outcome. Speaking from the USA, he said “we are confirmed in our position that a more robust procedure that includes open meeting and public comment was needed and thank Novitas for the opportunity to discuss the substance of their evidentiary review of Cxbladder products with them.

“We support efforts to ensure the Medicare program only pays for genetic testing services that are analytically valid, clinically valid, and clinically useful,” Dr Meintjes said.

“We will update investors as we gain further information on Cxbladder’s Medicare coverage status.”


Novitas is the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US laboratory.


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