CurrentBlue KCPolicy POL-PP-288

Immune Cell Function Assay Payment Policy

Defines Blue KC's reimbursement stance on immune cell function assays (e.g., Pleximmune™, Pleximark) and which provider lines of business and settings are impacted.

Policy Summary

PayerBlue KC

PolicyImmune Cell Function Assay Payment Policy

Policy CodePolicy POL-PP-288

Change TypeInitial publication

Effective Date07/01/2025

Next Review Date07/01/2026

Key ActionImmune cell function assays (e.g., Pleximmune™, Pleximark) are not reimbursed.

SourceLink

POLICY UPDATE CHANGES

Initial version published.

001Version

07/01/2025Effective

07/01/2026Next review

ActiveStatus

Commercial; Medicare AdvantageLines impacted

Coverage Determination

Coverage determination

Coverage is determined by the member's benefits and applicability at the time of the request. The following assays do not meet coverage criteria because available published scientific literature does not confirm they are required and beneficial for diagnosis or treatment.

Immune cell function assays (e.g., Pleximmune™, Pleximark) are considered not medically necessary/not covered due to a lack of available published scientific literature confirming clinical benefit.

Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request.

For all situations, an immune cell function assay (e.g., Pleximmune™, Pleximark) may not be reimbursed.

Assay Codes and Reimbursement

Listed assay codesCPTNot Covered

81560	Transplantation medicine (allograft rejection, pediatric liver and small bowel), measurement of donor and third-party-induced CD154+T-cytotoxic memory cells, utilizing whole peripheral blood, algorithm reported as a rejection risk score; Proprietary test: Pleximmune™; Lab/Manufacturer: Plexision, Inc.
86352	Cellular function assay involving stimulation (eg, mitogen or antigen) and detection of biomarker (eg, ATP).
0018M	Transplantation medicine (allograft rejection, renal), measurement of donor and third-party-induced CD154+T-cytotoxic memory cells, utilizing whole peripheral blood, algorithm reported as a rejection risk score; Proprietary test: Pleximark; Lab/Manufacturer: Plexision, Inc.

Policy Summary

PayerBlue KC

PolicyImmune Cell Function Assay Payment Policy

Policy CodePolicy POL-PP-288

Change TypeInitial publication

Effective Date07/01/2025

Next Review Date07/01/2026

Key ActionImmune cell function assays (e.g., Pleximmune™, Pleximark) are not reimbursed.

SourceLink

On This Page

Prior Authorization / Coverage Stance

Prior Authorization

Prior authorization / coverage stance — Immune cell function assays not reimbursed

Immune cell function assays (for example, Pleximmune™ and Pleximark) are not reimbursed under this policy. Coverage is determined by member benefits and applicability at the time of request; these tests do not meet coverage criteria due to insufficient published scientific literature demonstrating clinical benefit.

Applies to assays such as Pleximmune™ (proprietary test: Plexision, Inc.) and Pleximark (proprietary test: Plexision, Inc.).
Relevant CPT/HCPCS codes include 81560, 86352, and 0018M which are listed as not covered.

Key Definitions

Immune cell function assay

DefinitionImmune cell function assays involve measurement of peripheral blood lymphocyte response following stimulation to assess functionality of the cell-mediated immune response.

What is measuredIntracellular ATP levels and lymphocyte proliferation after stimulation.

Clinical purposeAssess degree of functionality of cell-mediated immune response (e.g., in transplant medicine contexts).

Proprietary assays

Example: Pleximmune™Proprietary test described with CPT 81560; Lab/Manufacturer: Plexision, Inc.

Example: PleximarkProprietary test described with CPT 0018M; Lab/Manufacturer: Plexision, Inc.

ManufacturerPlexision, Inc. listed as lab/manufacturer for both Pleximmune™ and Pleximark.