Immune Cell Function Assay denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested immune cell function assay testing for evaluation of his medical condition. Findings: Three physician reviewers found that the testing in dispute is a measure T-cell function and has been shown to have correlation with the degree of immunosuppression in a patient and associated rejection or infection. It is used in conjunction with drug level monitoring to guide immunosuppressive therapy decisions. There is sufficient support for the services at issue in this clinical setting. Immune cell function assay testing has becoming a standard of patient monitoring and has been used as an adjunct to monitoring the overall immunosuppressive state of the transplant patient. All told, immune cell function assay testing was likely to have been superior over other methods of evaluating this patient.

A 64-year-old female enrollee has requested immune cell function assay lab tests for evaluation of her medical condition. Findings: Two physician reviewers found that the immune cell function assay lab tests performed on the dates of service in dispute were likely to be more effective for this patient than other available options. The patient is status post bilateral lung transplantation and is at risk for both post-transplant lung rejection and opportunistic infections resulting from immunosuppression. Immune status monitoring of transplant recipients assists in identifying patients at risk of acute rejection, infection, and cancer, which are important sources of morbidity and mortality in these patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested an immune cell function assay for evaluation of the enrollee’s behavioral regression, strep pneumonia, cough, and autoimmune disease, not elsewhere classified. Three physician reviewers found that according to the medical literature, certain entities such as PANS and pediatric neuropsychiatric disorders after streptococcus infection (PANDAS) have been described as autoimmune disorders. However, the evidence that entities such as PANDAS are autoimmune has not been definitively established. PANS is a symptom complex whereby draft criteria have been established by experts to describe the entity.

Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement for a laboratory testing service, an immune cell function assay. In this case, the patient had been diagnosed with allergic rhinitis to animal dander, asthma, urticaria, mast cell activation syndrome, and food allergies. The patient’s blood work for urticaria, food allergy, and mast cell activation syndrome was within normal range. The patient’s blood work for environmental allergens was positive to dust mite and weed pollen. Per the records, the patient was overall stable on prescribed medications. Overall, appropriate alternative studies were already completed for this patient to evaluate his urticaria, allergic rhinitis, food allergy, asthma, and mast cell activation syndrome.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Immune Cell Function Assaywhen you appeal: reviewers routinely find that denials like yours didn’t hold up.