ClearNote Health, a cancer detection company focused on enabling people at risk for high-mortality cancers to live healthier lives, announced the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for the Avantect Pancreatic Cancer Test. 

Effective Oct. 1, 2023, the new CPT code, 0410U, establishes a reimbursement pathway for increased patient access and broader test adoption. The Avantect test is intended for patients at high risk for pancreatic cancer, such as those recently diagnosed with Type 2 diabetes or with a family history of pancreatic cancer.

In addition, the Centers for Medicare and Medicaid Services (CMS) announced that it has proposed preliminary reimbursement rate determinations for new and revised CPT codes issued by the AMA, including 0410U for the Avantect Pancreatic Cancer Detection Test. ClearNote Health is aligned with CMS on their reimbursement recommendation of $1,160.00 as this rate is similar to methods and procedures currently reimbursed on the existing Clinical Laboratory Fee Schedule. CMS is expected to issue a final determination on the rate for 0410U later this year. Final rates established by CMS for the clinical laboratory fee schedule will be effective on January 1, 2024.

Further reading: NCI Grant to Improve Early Detection of Pancreatic Cancer

“Receiving a CPT code and CMS preliminary rate recommendation mark important milestones for our organization and will expand patient access to early detection of pancreatic cancer,” says Dave Mullarkey, CEO of ClearNote Health. “Pancreatic cancer can be challenging to detect early. Detecting this disease in high-risk populations during Stage I can increase five-year survival rates to 80 percent or more and enable patients the best chance to access treatment options as soon as possible.”

Research from the National Institutes of Health (NIH) has proven patients newly diagnosed with Type 2 diabetes are almost eight times more likely to develop pancreatic cancer, and ClearNote Health aims to directly address the unmet need for early disease detection in high-risk patients. Its proprietary epigenomic methods use a standard blood draw to identify pancreatic cancer signals at its earliest stages by measuring levels of the 5-hydroxymethylcytosine (5hmC) in cell-free DNA.