The CPT code for PancreaSure is a Proprietary Laboratory Analyses (PLA) code and becomes effective October 1, 2025 and can then be used for the submission of healthcare claims to third-party payers in the US. It enables payers to efficiently identify, and process claims for PancreaSure, reducing administrative complexity in the billing process.

“Establishing a new CPT code represents an important early step in our US market access strategy,” said Jeff Borcherding, CEO.” We’re very pleased with the progress we’re making, but it is important to understand that this initiates the reimbursement pathway rather than completing it.”

Code assignment represents one of three required steps toward Medicare payment. The second step is to obtain a payment rate at which the PancreaSure test would be reimbursed by Medicare. Immunovia presented its pricing recommendation at a public meeting at the Centers for Medicare and Medicaid Services on June 27, 2025. This recommendation is currently under review. The third step to achieving Medicare reimbursement is to secure a positive coverage decision based on the clinical evidence supporting the use of PancreaSure.

About AMA CPT codes
The AMA CPT Editorial Panel assigns HCPCS (Healthcare Common Procedure Coding System) to report medical, surgical, and diagnostic services performed by healthcare professionals. The PLA code set, which comprises a subset of CPT codes, includes unique alphanumeric identifiers assigned by the AMA to proprietary clinical laboratory tests. These codes enable laboratories to submit claims to government and private payers, with each PLA code uniquely identifying a company's specific proprietary test. While assignment of a PLA code is a key milestone in pursuing reimbursement, it does not guarantee coverage or establish payment rates. Revenue generation depends on successful pricing determination and coverage decisions, processes with timelines outside Immunovia’s direct control.