Colitis Inflammatory Bowel Disease denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for infliximab (Inflectra), dosed at 22 mg/kg given every two weeks for two to four treatments. Assa and colleagues note that it is common for patients with very early onset inflammatory bowel disease (VEO-IBD) to require higher than standard doses of infliximab. Bramuzzo and colleagues report that while there are very few data regarding the use of infliximab in children with VEO-IBD, compared with older children, VEO-IBD patients have higher rates of infliximab failures, lower remission rates at one year, and more often experience adverse events during induction. In this case, the patient has VEO-IBD that has not responded to steroids, enteral nutrition therapy, or vedolizumab.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Stelara 90 mg every four weeks. The records provided for review document that this patient has failed multiple therapies including conventional therapy and high-dose Entyvio, which are recommended for the treatment of ulcerative colitis (Rubin, et al.; Sands, et al.). Subsequently, the patient experienced good results with Stelara every eight weeks, with return of symptoms and a low trough level. The provider has recommended treatment with Stelara every four weeks. Stelara has been demonstrated to be safe and effective in the treatment of ulcerative colitis.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: Th patient requested authorization and coverage for Percocet.The Centers for Disease Control and Prevention (CDC) guidelines state that when opioid therapy is used, a patient’s regimen should include nonpharmacologic therapy and nonopioid pharmacologic interventions. Additionally, the CDC noted that “Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.” The Federation of State Medical Boards (FSMB) guidelines noted that “continuation, modification or termination of opioid therapy for pain is contingent on the clinician’s evaluation of (1) evidence of the patient’s progress toward treatment objectives and (2) the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion.” The FSMB opined that dosage s…

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for an infliximab (Remicade) anti-body level test (laboratory procedure #80230 and #82542).Findings: Two of the three physician reviewers found the infliximab (Remicade) anti-body level test (laboratory procedure #80230 and #82542) was not likely to have been more beneficial for treatment of the patient’s medical condition than any available standard therapy. The service at issue is a quantitative monitoring assay designed to measure infliximab and antibodies to infliximab levels, intended to provide insight into factors contributing to a patient's loss of response and to guide treatment decisions.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving colitis inflammatory bowel disease, then check the rights and deadlines that apply to your plan.