Through its Clinical Lab Fee Schedule (CLFS) annual payment determination process, CMS sets the price for lab tests provided to beneficiaries of Medicare, the U.S. government-funded health insurance program for people age 65 and older. The CLFS rate set by CMS also provides an important benchmark price for reimbursement by private insurance companies.

“The price of $897 fairly reflects the clinical and economic value of the PancreaSure test and we are very pleased that CMS agreed with our pricing recommendation,” said Jeff Borcherding, Immunovia’s CEO. “This is an important milestone in our efforts to secure reimbursement for the PancreaSure test.”

The preliminary payment determination is not yet final. After a period of public comment, CMS will finalize its basis for payment decision in November and it will be effective January 1, 2026.

Setting the CLFS payment rate at which the PancreaSure test would be reimbursed by Medicare represents the second of three required steps toward Medicare payment. On July 1, Immunovia announced that it had achieved the first step: obtaining a Current Procedural Terminology (CPT) code from the American Medical Association (AMA) to submit claims to healthcare insurers in the US. The CPT code, which becomes effective October 1, 2025, enables insurance companies and government payers to efficiently identify and process claims for PancreaSure. The third step to achieving Medicare reimbursement is to secure a positive coverage decision based on the clinical evidence supporting the use of the PancreaSure test.