Equity research Immunovia: PancreaSure test achieves CPT code assignment

Immunovia announced on July 1 that it had reached an important milestone: The American Medical Association (AMA) has assigned its Pancreasure test a proprietary laboratory analyses (pla) code. This new CPT code marks a necessary step in the process to eventually obtain reimbursement for PancreaSure.

While the PLA code is required for reimbursement purposes, it does not entail reimbursement coverage or payment rates. Rather, the code has more to do with accurate billing and streamlining claims processing. In the words of the AMA, PLA Codes are an addition to the CPT code set. They are alpha-numeric CPT codes with a corresponding descriptor for labs or manufacturers that want to more specifically identify their tests. Furthermore, tests with PLA codes must be performed on humans.

The CPT code assignment is the first of three major steps required for Medicare reimbursement. Regarding the second step, Immunovia has already presented its pricing recommendation to the Centers for Medicare and Medicaid Services (CMS), and the decision is currently under review. We understand that Immunovia is referring to the previously marketed IMMray PanCan-d test with the aim to achieve similar pricing of some USD 897 (supported by a so-called taxonomy crosswalk). The final more long-term step will be securing a positive coverage determination supported by increasing clinical evidence of PancreaSure’s value. Specifically, clinical utility i.e., demonstrating that the test changes how physicians practise screening and/or improves patient outcomes, is the key element.

Parallel to the efforts to secure reimbursement, Immunovia is preparing for the launch of PancreaSure in the US, which is already planned for this quarter. While initial sales are “out of pocket” and thus likely to be modest in value, the gradual rollout and volume uptake in the targeted screening centres will be important indicators to follow.

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