Immune Cell Function Assay
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Policy governing coverage and medical necessity of immune cell function assays (ImmuKnow and Pleximmune) to monitor immune function after solid organ and hematopoietic stem‑cell transplantation for BCBSRI members.
No material clinical or coverage changes in this revision.
Coverage Determination
Not covered / Not medically necessary
Coverage determination for Medicare Advantage Plans and Commercial Products
Evidence insufficient to determine effects on health outcomes
Some genetic testing services and biomarker testing may be excluded from coverage for certain self-funded groups by contract. These contract exclusions relate to the state Biomarker Testing Mandate (R.I.G.L. §27-19-81) and can limit expanded coverage of biomarker testing for those groups. Providers should consult the member’s Benefit Booklet and the Genetic Testing Services or Proprietary Laboratory Analyses policies for the specific list of genetic testing services that are covered with prior authorization, considered not medically necessary, or are contract exclusions.
Related policies and the member’s employer or subscriber agreement govern whether a particular biomarker or genetic test is excluded; when in doubt, verify plan-specific coverage via the provider call center.
Services determined to be not medically necessary or otherwise non-covered under the member’s plan are excluded from coverage according to the member’s subscriber agreement or employer agreement. For member-specific benefits and eligibility, contact the provider call center.
If a service is determined to be not medically necessary or is a non-covered benefit, providers may not bill the member unless the member was informed and provided written agreement in advance to accept financial liability. Refer to the provider participation agreement for applicable billing provisions.
This policy addresses the use of immune cell function assays (specifically ImmuKnow, CPT 86352, and Pleximmune, CPT 81560) to monitor and predict immune function after solid organ transplantation and hematopoietic stem-cell transplantation. The policy stance is that use of these assays for monitoring or prediction of immune function is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because the evidence is insufficient to demonstrate improved health outcomes.
Providers should note that laboratories are not permitted to obtain clinical authorization or participate in the authorization/appeal process on behalf of the ordering physician; only the ordering physician may engage in those administrative processes.
A determination that a service is not medically necessary or is a non-covered benefit directly affects coverage and potential financial liability. For Commercial Products the immune cell function assays addressed in this policy are considered not medically necessary; for Medicare Advantage they are not covered. Such determinations mean the payer will not reimburse for the service under the member’s plan.
When services are not covered or are deemed not medically necessary, providers must follow the notification and consent rules before collecting payment from members—specifically, members must be informed and agree in writing to accept financial responsibility if the service is provided despite non-coverage.
Coding and Test Thresholds
| 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 |
| 86352 | Cellular function assay involving stimulation (eg, mitogen or antigen) and detection of biomarker (eg, ATP) |
Prior Authorization and Provider Responsibilities
Prior authorization requirement — labs may not obtain authorization
The policy states prior authorization is Not applicable; however, laboratories are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician. Unauthorized laboratory services will be denied and may be billed as the financial liability of the participating laboratory.
- Prior authorization: Not applicable
- Laboratories may not obtain clinical authorization or participate in authorization on behalf of the ordering physician
- Laboratory services without authorization will be denied and may be billed to the laboratory
Verify prior authorization and benefits for the individual member
Verify member-specific prior authorization and coverage requirements through the provider call center or payer portals, since benefits and prior authorization rules are governed by the member's subscriber agreement or employer agreement.
- Coverage and prior authorization requirements are determined by the member's subscriber agreement, member certificate, or employer agreement
- For member-specific benefits or authorization status, call the provider call center
Ordering physician must handle authorization and appeals (action required)
Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to prior authorization or medical necessity; laboratories and their representatives must not obtain authorization or facilitate appeals on the physician’s behalf.
- Ordering physician is sole party permitted to handle authorization and appeals
- Use of a laboratory representative or third party to obtain authorization is prohibited and may be deemed a policy violation
Improper authorization support risks termination and denial
If a laboratory or third party is found to have supported any portion of the authorization process, BCBSRI may take severe action up to termination from the provider network; services provided without proper authorization will be denied as the financial liability of the participating laboratory.
- BCBSRI may terminate a provider found to have improper authorization support by a lab or third party
- Unauthorized lab services will be denied and may not be billed to the member (financial liability of the laboratory)
Ordering physician responsibility for authorization/appeals
Only the ordering physician may request or manage prior authorization, appeals, or other administrative steps related to medical necessity; laboratories and their representatives must not perform these tasks for the ordering physician.
- Do not delegate authorization or appeal tasks to laboratories or their representatives
- Ensure the ordering physician personally handles required documentation and submission
Confirm benefits and eligibility via subscriber/employer agreement and provider call center
Determine benefits and eligibility from the member's subscriber agreement, member certificate, or employer agreement; for member-specific questions about benefits or prior authorization, contact the BCBSRI provider call center.
- Subscriber agreement, member certificate, or employer agreement govern coverage
- Contact the provider call center for member-specific benefits or eligibility
Services without authorization denied; laboratory may be financially liable
Laboratory services provided without proper authorization will be denied and may be billed as the financial liability of the participating laboratory; such services may not be billed to the member.
- Unauthorized laboratory services denied and financial liability rests with the laboratory
- Do not bill members for unauthorized lab services
Denials for non-covered or not medically necessary services; member billing restrictions
If services are determined not medically necessary or are non-covered benefits per the member’s contract, they may be denied. Providers may not charge the member for such services unless the member was informed in advance and agreed in writing.
- Non-covered or not medically necessary services may be denied per subscriber/employer agreement
- Charging the member is only permitted with prior written member agreement; refer to participation agreement provisions
Clinical Background
Therapeutic drug monitoring and assessment of clinical toxicity are commonly used to manage immunosuppression after solid organ and hematopoietic cell transplantation but may not fully reflect overall immune function. Immune cell function assays (for example, ImmuKnow which measures CD4+ ATP after mitogen stimulation, and Pleximmune which measures donor-specific CD154+ T-cytotoxic memory cell responses reported as an Immunoreactivity Index) were developed to characterize individual immune profiles and potentially guide immunosuppression.
However, the evidence regarding the clinical validity and utility of these assays is limited and heterogeneous, and therefore they are not supported for routine clinical use in post-transplant immune monitoring under this policy.
Key Terms and Test Descriptions
Use After Transplant
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