Cancer diagnostics company Pacific Edge has released a new proposed Local Coverage Determination (LCD) governing the reimbursement of its Cxbladder tests by Medicare, the US National Health Insurance provider.

The proposed LCD, released by the Medicare Administrative Contractor (MAC) Novitas, notes the Cxbladder tests are 'not considered medically reasonable and necessary', the threshold required for coverage under the US Social Security Act.

Novitas has provided for a 45-day notice and comment period, during which time all interested stakeholders may submit comments, and an Open Public Meeting on 11 August 2023.

Pacific Edge Chief Executive Dr Peter Meintjes believes the evidentiary review of the LCD misunderstands the intended use of the Cxbladder tests and will present Novitas with important bladder cancer-specific medical knowledge at the Open Meeting.

Pacific Edge is continuing to bill and receive reimbursement by Medicare and Medicare Advantage for its tests.

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