NEW YORK – Interpace Diagnostics said Friday that starting next month it will no longer accept specimens for its PancraGen test in light of the local coverage determination issued by Medicare administrative contractor Novitas Solutions that ends reimbursement for the assay, as well as several other molecular diagnostics on the market.
The Centers for Medicare & Medicaid Services had delayed implementation of the LCD by 60 days earlier this year but has now confirmed its finalization as of April 24.
The progression of the LCD has been a roller coaster for test makers. Issued as a draft in 2022, an initial LCD was finalized in mid-2023. Interpace had said at that time that it would end testing. However, Novitas rescinded that final LCD and reissued it as a draft a month later after outcry from laboratory organizations, allowing Interpace to continue testing patients through today.
PancraGen is a DNA-based diagnostic test that assesses the risk of progression to cancer in patients with a pancreatic cyst. Because the test is primarily ordered for Medicare patients, Interpace does not believe it can continue offering it without reimbursement. The firm will stop accepting samples after May 2.
"We know that clinicians rely on our testing and understand the challenges this decision imposes on the physicians we serve — and on their patients. We will be working with them to help during this transition as best as possible," Interpace Chief Commercial Officer Rob Renjilian said in a statement.
"The loss of Medicare reimbursement also necessitates the restructuring of Interpace," added CEO Tom Burnell. "As stated previously, we believe the company is sustainable without PancraGen, and we expect that our testing franchise for indeterminate thyroid nodules … will allow us to continue to remain profitable in 2025 and beyond," he said.