Novitas Extends Medicare Coverage Review for Pacific Edge

Highlights:

• Medicare Review Extension: Novitas has received an extension from CMS to finalize or withdraw the Local Coverage Determination (LCD) for Pacific Edge's 'Genetic Testing for Oncology'.
• Continued Reimbursement: Pacific Edge’s Cxbladder tests will continue to receive Medicare and Medicare Advantage reimbursements at historical rates, adhering to medical necessity guidelines during the extended review period.
• Awaiting Final Decision: Pacific Edge will keep shareholders updated on the status and timeline of the LCD, with no further comments until a final decision is reached.

Extension Confirmed

Pacific Edge (NZX: PEB), a cancer diagnostics company, announced that Novitas, the Medicare Administrative Contractor (MAC) responsible for their US lab, has received an extension to finalize or withdraw the Local Coverage Determination (LCD) for 'Genetic Testing for Oncology' (DL 39365). The update was shared on the Novitas website, noting the extension was granted to allow thorough consideration of all feedback from interested parties.

Implications for Cxbladder Tests

The LCD review, which impacts Medicare coverage for Pacific Edge's Cxbladder Triage, Detect, and Monitor tests, was initially expected to be concluded within 365 days of its posting. However, the extended deliberation period means these tests will continue to be reimbursed by Medicare and Medicare Advantage payers at historical rates, as long as they meet medical necessity guidelines.

Awaiting Final Decision

Pacific Edge CEO, David Darling, expressed that while the company anticipates a final decision on the LCD, the exact timeline remains uncertain. The company reassured shareholders that they will be informed of any updates regarding the LCD status and resolution timeline. Until a final decision is made, Pacific Edge will not provide further comments on the matter.

This development underscores the complexities of securing Medicare coverage and the importance of thorough review processes to ensure all stakeholder feedback is considered. As Pacific Edge continues to navigate this process, the company remains committed to providing innovative cancer diagnostic solutions and maintaining transparency with its shareholders.

Looking Ahead

The outcome of the LCD review is critical for Pacific Edge as it determines the future reimbursement framework for its diagnostic tests. Stakeholders and investors are advised to stay tuned for further updates from the company, as the extension granted by Novitas signifies an ongoing commitment to a comprehensive review process.

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