Novitas Confirms Medicare Coverage Review Extension

Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, has confirmed that it has been granted an extension to finalise or withdraw the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365).

In a post on its website on Friday (Saturday morning NZDT), the MAC noted: “Novitas is considering all the feedback from interested parties regarding the Genetic Testing for Oncology LCD. An extension has been granted by the [Centers for Medicare & Medicaid Services2] in order for all comments to be considered thoroughly. Future updates will be published to this website and the Medicare Coverage Database.”

Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalised last Thursday evening (NZDT), i.e. within 365 days of the initial posting.

The continued deliberation on the LCD means that Pacific Edge’s tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates, subject to medical necessity guidelines.

Pacific Edge continues to expect Novitas to finalise the LCD, but the timeframe is unknown. It will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution, but will not be making further comment on the matter until then.

1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 The Centers for Medicare and Medicaid Services (CMS) delegates to Novitas the power to make the coverage determination. Novitas is accountable to CMS for the decision.

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