Pacific Edge has posted another record quarter in laboratory testing throughput for its Cxbladder products — ironically the announcement on the same day it would have lost Medicare coverage in its key United States market.
Novitas recently announced it would not make Local Coverage Determination effective on July 17 but would republish with the opportunity for open meetings and public comment.
In Pacific Edge’s quarterly update released yesterday, chief executive Dr Peter Meintjes said that was the best possible result that the cancer diagnostic company could have expected from its intense efforts since Novitas announced on June 2 what it believed was a substantially flawed LCD.
"Now, Pacific Edge will have the opportunity to address Novitas’ concerns and convey our confidence that our primary clinical evidence is sufficient to support continued Medicare coverage of the tests we currently have in the US market," he said.
Since the finalisation of the adverse LCD, Pacific Edge’s focus, in conjunction with various partners, had been on pursuing a range of actions aimed at retiring or delaying its implementation on the grounds that Novitas did not follow statutorily regulated procedure.
"We now appear to have prevailed on these procedural matters. Consequently, until we are further advised, and until we have concluded the notice and comment period and a new LCD is finalised, Pacific Edge expects to continue to bill and receive reimbursement for our tests from Medicare and Medicare Advantage," Dr Meintjes said.
Pacific Edge would continue to argue the new approach in the LCD to use third-party databases to preemptively non-cover diagnostic tests without evidentiary review was unprecedented, not statutorily supported and possibly unlawful.
However, it would focus more heavily on the evidentiary review in the LCD of Cxbladder products, rebutting what its medical team and many prominent urology opinion leaders perceived "as a flawed analysis that lacks understanding of how to use our test and lacks knowledge of the standard of care in urology", he said.
Test volumes processed rose to a new record in the first quarter of the 2024 financial year rising to 9,706, a 9% rise on the 8,8773 tests in the previous quarter.
The volume processed in Q1 24 represented a 38% increase on the 7,056 tests processed in the same quarter of the previous year (Q1 23). US volumes led the growth rising to 8,627 in Q1 24, a 10% increase on the 7,816 tests in Q4 23.
The figure also represented a 42% increase on the 6,073 tests processed in Q1 23.
Pacific Edge’s annual meeting would be held in Auckland and online next Thursday.
