Yesterday, the Dunedin-based listed cancer diagnostic company announced an update to its billing policies in the wake of an unfavourable decision from Novitas, the Medicare administrative contractor with jurisdiction for Pacific Edge’s laboratory in Hershey, Pennsylvania.
The enhanced patient responsibility approach followed the finalisation in early June of a local coverage determination (LCD) that could result in Medicare coverage of Cxbladder tests ceasing on July 17.
Medicare and Medicare Advantage tests represented about 60% of commercial Cxbladder tests performed in the year to March 31, 2023, accounting for 77.7% of operating revenue.
Since the announcement, the company has been working through the issue, particularly the legal aspects.
From July 17, Pacific Edge will provide for enhanced patient responsibility where a patient’s insurer declines to pay for a Cxbladder test.
Pacific Edge will also update its patient assistance programme to assist lower-income patients with making their bill more affordable.
The new process requires all patients not covered by a contracted health insurer to be informed by the ordering physician of the patient’s responsibility when ordering the test.
Chief executive Dr Peter Meintjes said "thousands" of urologists across the United States and around the world shared the company’s view that Cxbladder offered clinically valuable and actionable information, despite the Novitas determination.
"This information can improve the standard of care for patients suspected of or previously affected by bladder cancer, can offer improved patient management options for physicians and spare patients from unnecessary invasive urinary tract examinations," he said.
When clinicians explained to patients that a Cxbladder test might allow them to safely avoid a cystoscopy, Pacific Edge expected many would accept some patient responsibility for payment if their insurer declined to cover the test.
"While the impact on demand for our tests in the US is uncertain, we expect the new approach to improve collections in the event of denial from any non-contracted insurer, including Medicare, and make some contribution to revenues after July 17", Dr Meintjes said.
Pacific Edge’s annual meeting is being held in Auckland on July 27.