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DESCRIPTIONCareful monitoring of lifelong immunosuppression is required to insure long-term viability of solid organ allografts without incurring increased risk of infection. Monitoring of immunosuppression attempts to balance the dual risks of rejection and infection. Currently, immunosuppression is determined by testing for clinical toxicity (e.g., leukopenia, renal failure) and by therapeutic drug monitoring (TDM) when available. However, drug levels are not a surrogate for overall drug distribution or efficacy because pharmacokinetics often differs among individuals due to clinical factors such as underlying diagnosis, age, gender and race; circulating drug levels may not reflect the drug concentration in relevant tissues; and levels of an individual immunosuppressant drug may not reflect the cumulative effect of other concomitant immunosuppressants. The main value of TDM is the avoidance of toxic levels and monitoring patient compliance. Further, the appropriate level of immunosuppression may vary from person to person. Individual immune profiles, such as an immune cell function assay, could support clinical decision-making and help to manage the risk of infection from excess immunosuppression and the risk of rejection from inadequate immunosuppression in immunosuppressed patients.
ImmuKnow® (Cylex) is an immune cell function assay cleared for marketing by the FDA in April, 2002 to detect cell-mediated immunity (CMI) in an immunosuppressed patient population. The assay measures the concentration of adenosine triphosphate (ATP) in whole blood following 15-18 hour incubation with the mitogenic stimulant, phytohemagglutinin (PHA). In cells that respond to stimulation, increased ATP synthesis occurs during incubation. Concurrently, whole blood is incubated in the absence of stimulant for the purpose of assessing basal ATP activity. CD4+ T-lymphocytes are immunoselected from both samples using anti-CD4 monoclonal antibody-coated magnetic particles. After washing the selected CD4+ cells on a magnet tray, a lysis reagent is added to release intracellular ATP. A luminescence reagent added to the released ATP produces light measured by a luminometer, which is proportional to the concentration of ATP. The characterization of the cellular immune response of a specimen is made by comparing the ATP concentration for that specimen to fixed ATP level ranges.
On April 2, 2002, Cylex obtained 510(k) clearance from the FDA to market the Immune Cell Function Assay based on substantial equivalence to two flow cytometry reagents (“predicate devices”) manufactured by Becton Dickinson, the TriTest™ CD4 FITC/CD8 PE/CD3 PerCP Reagent and the MultiTest™ CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC Reagent. These reagents are used to determine CD4+ T-lymphocyte counts in immunocompromised patients. The FDA-indicated use of the Cylex Immune Cell Function Assay is for the detection of cell-mediated immunity in an immunosuppressed population.
POLICYUse of the immune cell function assay to monitor and predict immune function after solid organ transplantation is considered investigational.
Use of the immune cell function assay for all other indications, including but not limited to hematopoietic stem cell transplantation, is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/21/2009: Policy added
11/19/2009: Approved by MPAC
3/11/2010: Code section updated. New CPT code 86352 added to non-covered table.
11/17/2010: Policy reviewed; no changes.
02/24/2012: Added the following policy statement: Use of the immune cell function assay for all other indications, including but not limited to hematopoietic stem cell transplantation, is considered investigational.
03/13/2013: Policy reviewed; no changes.
03/05/2014: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association policy # 2.04.56
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.