Major US reimbursement milestone achieved by Pacific Edge

Cancer diagnostics company Pacific Edge (NZX: PEB) is pleased to advise that the preliminary national CMS reimbursement rate of US$760 (NZ$1,166) has been publicly notified. The national reimbursement rate covers the Cxbladder tests awarded national CPT codes in the USA earlier this year.

The national CMS reimbursement rate is for all patients covered under the Centers for Medicare and Medicaid Services (CMS) and will apply to Cxbladder test claims submitted to CMS once Pacific Edge receives inclusion in the Local Coverage Determination (LCD) for Medicare coverage.

The rate, set by the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, will be open for public comment until 22 October 2018 and will be published in the Clinical Laboratory Fee Schedule in November 2018 and effective from 1 January 2019.

CEO of Pacific Edge, David Darling, said: “This is a major reimbursement milestone and the second of the three significant components of the US reimbursement process which Pacific Edge has now achieved. The reimbursement rate of US$760 per test is within an acceptable commercial range and in line with other similar molecular diagnostic laboratory tests in the US.”

The first component in the reimbursement process was the granting of dedicated CPT codes by the American Medical Association, which was achieved earlier in 2018. These national codes are only issued for tests that have entered the mainstream, where the volume of tests used by physicians has been shown to be indicative of significant adoption and for which the clinical efficacy of the test is well established and documented in peer reviewed literature.

The second component is the notification of the national reimbursement rate associated with the Codes, and the third is inclusion in the Local Coverage Determination (LCD) for CMS coverage. The national reimbursement rate will set the reimbursement rate for tests ordered by physicians for CMS patients, once the LCD inclusion is received.

David Darling said: “We have been working hard to complete the reimbursement milestones in the US and we are delighted with this achievement. Once the LCD is attained, we will receive more consistent reimbursement for CMS claims. Having the national CMS reimbursement rate in place on the Clinical Laboratory Test Fee Schedule is expected to positively impact negotiations with private insurers and funders in the USA to gain coverage for our tests in their insurance plans.”