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Pacific Edge is relieved by Novitas1 and First Coast's decision to delay the implementation of the Local Coverage Determination (LCD, L35396) that would have ceased Medicare coverage for Cxbladder in the US on 17 July 2023.
The LCD will not proceed as planned and will undergo the LCD process again with an open meeting and public comment period, although no specific timeline for this process has been set as of now.
Pacific Edge CEO Dr. Meintjes affirms their support for only paying for genetic testing services that are analytically valid, clinically valid, and clinically useful in the Medicare program, and promises to provide updates on the Medicare coverage status for Cxbladder as more information becomes available.
Pacific Edge modifies its billing policies in the US for Cxbladder tests, enforcing enhanced patient responsibility if their insurance declines to cover the test and also updating its Patient Assistance Program for lower-income patients from 17 July 2023.
Patients not covered by a contracted health insurer will need to sign an Advance Beneficiary Notice of Non-Coverage (ABN), and are encouraged to complete a Patient Assist form to help make their bill more manageable.
Changes follow the potential discontinuation of Medicare coverage for Cxbladder tests from 17 July 2023, although the impact on test demand is unclear, the new policy is expected to improve collections from denied bills from non-contracted insurers, including Medicare.
Medicare coverage of Cxbladder tests is expected to cease from 17 July 2023, affecting Pacific Edge's revenue significantly.
Pacific Edge plans to explore all available legal options, including potential appeals, with US-based lawyers, partners, and impacted companies.
CEO Dr. Peter Meintjes believes Novitas' decision is based on a misunderstanding of biomarkers' role in risk-stratifying patients with hematuria and an unbalanced emphasis on negative comments in Cxbladder publications.