Pacific Edge battles out proposed end of US Medicare coverage for Cxbladder tests

New Zealand company Pacific Edge (ASX: PEB) has updated its billing policies in the US for its range of Cxbladder non-invasive genomic urine tests for the detection and management of bladder cancer.

From 17 July, the company will provide for enhanced patient responsibility in cases where a patient’s health insurer declines to pay for a test.

The new process requires doctors to inform their patients of the patient’s responsibility when ordering a test, especially in cases where the patient is not covered by a contracted health insurer.

All patients will be required to sign an Advance Beneficiary Notice of Non-Coverage (ABN) and be encouraged to complete a patient assist form as part of the ordering process.

Pacific Edge said it would also update its patient assistance program to help lower income patients with making their bills more affordable.

End of Medicare coverage

The approach towards enhanced patient responsibility follows a move in June which could see the end of Medicare coverage for Cxbladder tests this month.

It involved the finalising of a local coverage determination (LCD) by Novitas, which is the Medicare administrative contractor (MAC) with jurisdiction for Pacific Edge’s laboratory in Pennsylvania.

The LCD considered the Cxbladder range of tests (including Triage, Detect, Monitor and Resolve) to be not ‘medically reasonable and necessary’ which is the threshold required for coverage under the US Social Security Act (which administers Medicare).

‘Surprised and disappointed’

At the time of the ruling, Pacific Edge chief executive officer Dr Peter Meintjes said the company was “surprised and disappointed” with the LCD outcome.

“The local coverage determination appears to materially misunderstand the important role that biomarkers can play in first line diagnostics for risk-stratifying patients with hematuria into those that would benefit from potentially more invasive medical attention and those that would not,” he said.

“While Novitas appears to have reviewed all available evidence for Cxbladder, we believe its analysis has sought to predominantly emphasise negative comments in Cxbladder publications… likely mischaracterises issues or confounding factors with our evidence that were addressed in subsequent publications and routine commercial testing, while also dismissing the support Cxbladder receives from key opinion leading urologists.”

Clinically-valuable information

Dr Meintjes said that despite Novitas’ decision, “thousands of urologists” across the US and around the world shared the view that Cxbladder offers clinically-valuable and actionable information.

“This information can improve the standard of care for patients suspected of, or previously affected by, bladder cancer… it can offer improved patient management options for physicians and spare patients from unnecessary invasive urinary tract examinations,” he said.

“When clinicians explain to patients that a Cxbladder test may allow them to safely avoid a cystoscopy, we expect many will accept some responsibility for payment if their insurer declines to cover the test.”

Delayed implementation

Earlier this month, Novitas agreed to a delayed implementation of the LCD which would have seen Medicare coverage cease next week.

Dr Meintjes said it was expected to go through a second review process with an open meeting and public comment period over an undisclosed timeframe.

“We are confirmed in our position that a more robust procedure is needed and thank Novitas for the opportunity to consult on the substance of its evidentiary review of Cxbladder products,” he said.

“We support efforts to ensure the Medicare program only pays for genetic testing services which are analytically and clinically valid, and clinically useful.”

In the 12 months to end March, Medicare and Medicare Advantage tests represented 60% (or 13,800) of commercial Cxbladder tests and accounted for 77.7% of Pacific Edge’s operating revenue.