NEW YORK – Interpace Biosciences announced on Monday that it will stop offering its PancraGen test for risk stratification of pancreatic cancer after the Centers for Medicare and Medicaid Services rescinded coverage and reimbursement of the assay.
The molecular diagnostic test assesses the risk of pancreatic cancer posed by pancreatic cysts and integrates the results of first-line tests and procedures — such as imaging, fluid chemistry, and cytology — with its molecular test results, the company said in a statement. It is intended to help clinicians diagnose pancreatic cancer and inform optimal management of patients.
Interpace President and CEO Tom Burnell said in a statement that the test has been reimbursed by CMS for 10 years and that nearly 70,000 patients have been tested with the assay. Because the test is primarily ordered for Medicare patients, without reimbursement from CMS the company will not be able to continue offering PancraGen, he added.
According to the local coverage determination released last week by Medicare Administrative Contractor Novitas that analyzed peer-reviewed literature about the test, there has been no proposed process for combining PancraGen's results with consensus guidelines for decision-making, and that the data reporting outcomes in patients where the test results and consensus guidelines disagreed was limited. Novitas added that there are no prospective studies with a simultaneous control population that prove the test can affect patient-relevant outcomes, such as survival or reduction in unnecessary surgeries.
"The evidence reviewed moreover does not demonstrate that PancraGen has incremental clinical value in the prognosis of pancreatic cysts and associated cancer," Novitas said.
The MAC also noted that despite its claim that the assay is meant as an adjunct to first-line testing for pancreatic cysts, the firm has not effectively tested or assessed how PancraGen performs for solid pancreaticobiliary lesions, and, as a result, the evidence reviewed doesn't demonstrate that the assay has incremental clinical value for the diagnosis of those lesions.
Novitas said that there are no studies assessing the analytical validity of the test and that without such data, the technical performance of the test cannot truly be determined. Another MAC, First Coast Service Options, has aligned its coverage with Novitas and will not cover the test.
The coverage determination goes into effect on July 17. Burnell said that the company will "pursue every available option to reverse this decision" before it goes into effect and that the test will remain available until it's no longer economically feasible to offer it.