Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's ileitis

Treatment: the laboratory test for the measurement of serum concentrations of Ustekinumab (UTS) levels and antibodies of Ustekinumab (ATU) (lab test that measures antibodies) code 84999

The insurer denied coverage for the laboratory test for the measurement of serum concentrations of Ustekinumab (UTS) levels and antibodies of Ustekinumab (ATU) (lab test that measures antibodies) code 84999

The denial is upheld

According to the medical records, the patient had a history of Crohn's disease. He was diagnosed with elevated C-reactive protein and terminal ileal stenotic inflammation revealed on an abdominal computed tomography scan. A colonoscopy also revealed a deformed, fibrotic and stenotic ileocecal valve. The patient's treating physician ordered a laboratory test for the measurement of serum concentrations of Ustekinumab (UTS) levels and antibodies of Ustekinumab (ATU). As per the report from Prometheus Biosciences, there was detectable serum Ustekinumab but undetectable antibodies to Ustekinumab. The patient had the diagnosis of Crohn's ileitis. The patient was treated with prednisone for two weeks due to complaints of intermittent exacerbations of symptoms with abdominal cramping, pain, nausea and vomiting. At a visit, the patient stated he was feeling okay. it was noted the patient's treatment plan included Stelara, Pepcid, Omeprazole, Ondansetron, Vitamin D and Vitamin B. 

Per Freeman et. al., "The available evidence suggests that these tests have modest predictive accuracy for clinical status; direct test accuracy comparisons in the same population are needed. More clinical trial evidence from test-treat studies is required before the clinical utility of the tests can be reliably evaluated."      

The testing for the drug and antibody levels for ATU is FDA approved.     

There continues to be insufficient evidence in the peer-reviewed published medical literature to clearly determine the role of the measurement of antibodies to Stelara, whether performed separately or combined with testing blood levels. There is insufficient evidence to demonstrate the use of these tests results in improved health outcomes compared to usual clinical management.     

The management of inflammatory bowel disease with biologic therapy is directed by the patient's clinical response to the medication. If the therapy proves less than beneficial, the dose can be increased. If benefit is not seen, then the therapy is discontinued, regardless of the presence of an antibody. Furthermore, if there is presence of an antibody but the patient is tolerating and benefiting from the therapy, there is no indication to discontinue the treatment based solely on a laboratory result such as the ATU drug and antibody tests. As such, the balance of the scientific literature does not demonstrate that the ATU drug and antibody tests is more likely to be beneficial to this patient than the available approach for the management of inflammatory bowel disease with biologic therapy.     

There are no adverse risks associated with blood testing in general or this test in specific.     

The carrier's denial of the laboratory test for the measurement of serum concentrations of Ustekinumab (UTS) levels and antibodies of Ustekinumab (ATU) (lab test that measures antibodies) code 84999 performed should be upheld.