LCD delay welcomed by Pacific Edge

Pacific Edge Cxbladder tests. PHOTO: ODT FILES
Pacific Edge Cxbladder tests. PHOTO: ODT FILES
Pacific Edge has welcomed a decision to delay the implementation of the local coverage determination [LCD] that would have resulted in Medicare coverage of its Cxbladder tests ceasing in the United States on July 17.

In an email to its US lawyers, the US Department of Health and Human Services associate general counsel Janice Hoffman said details were being worked out but there was commitment from Novitas and First Coast - the two Medicare administrative contractors - that the LCD would not proceed as is and that it would go through the process again with an open meeting and public comment period.

Medicare and Medicare Advantage tests represented about 60% of commercial Cxbladder tests performed in the year to March 31, accounting for 77.7% of operating revenue. No timeframe was provided for the process.

Pacific Edge chief executive Dr Peter Meintjes was pleased with the outcome.

"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 programme only pays for genetic testing services that are analytically valid, clinically valid and clinically useful."

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