Immune cell function assays for transplant monitoring
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This policy governs coverage determinations for laboratory immune cell function assays (eg, ImmuKnow, Pleximmune) used to monitor or predict immune function in solid organ and hematopoietic stem-cell transplant recipients for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage Determinations
General coverage
Coverage determination
Supported by regulatory summaries and evidence review for ImmuKnow and Pleximmune in the policy.
The following services are explicitly listed as not covered or not medically necessary: CPT 86352 — Cellular function assay involving stimulation (eg, mitogen or antigen) and detection of biomarker (eg, ATP); and CPT 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 (Effective 1/1/2022).
For Commercial Products, use of immune cell function assays to monitor and predict immune function after solid organ transplantation, hematopoietic stem‑cell transplantation, and all other indications is considered not medically necessary because the evidence is insufficient to determine the effects of the technology on health outcomes.
Coding and Billing
| 86352 | Cellular function assay involving stimulation (eg, mitogen or antigen) and detection of biomarker (eg, ATP) |
| 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 (Effective 1/1/2022) |
Provider Responsibilities & Billing Impact
Prior Authorization
No prior authorization is applicable for these tests per the policy.
Benefit Verification
Benefits and eligibility are determined by the member's subscriber agreement, Evidence of Coverage, or employer agreement and may vary by contract. For member-specific benefits and eligibility, providers must contact the provider call center.
Member Responsibility & Denial Risk
Providers should confirm member responsibility before providing services. If a service is determined to be not medically necessary or is a non-covered benefit, the provider may not bill the member unless the member was informed in advance and agreed in writing to accept financial responsibility.
Step Therapy
No step therapy requirements are specified in this policy.
Background and Rationale
Monitoring immunosuppression after solid organ or hematopoietic cell transplantation requires balancing the competing risks of allograft rejection and infection. Therapeutic drug levels do not fully capture overall immune responsiveness, so assays that measure cellular immune function (for example, ATP production in stimulated CD4+ cells or donor‑induced CD154 expression with an Immunoreactivity Index) have been proposed to individualize immunosuppression. However, regulatory clearance or approval (eg, ImmuKnow 510(k); Pleximmune HDE) does not by itself establish clinical utility, and the policy finds the published evidence insufficient and inconsistent to demonstrate improved health outcomes from routine use of these immune function assays for transplant monitoring.
Test Definitions and Terms
Evidence and Evaluation Context
Test evaluation context and evidence summary
Evaluation context: assays are described for pretransplant and posttransplant use to assess rejection and infection risk, and Pleximmune has FDA HDE approval for predicting rejection within 60 days in pediatric liver and small bowel patients, but the policy concludes evidence is insufficient to support coverage.
- ImmuKnow and Pleximmune are described as assays measuring immune response (ATP production for ImmuKnow; CD154/IR for Pleximmune).
- Clinical utility is judged insufficient in the policy despite available regulatory clearances/approvals.
Post-Transplant Testing Context
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