Crohn's Disease denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 36-year-old man with Crohn’s disease of the ileocolon for at least four years with a diagnosis established at surgery. He has been treated with Asacol, prednisolone, methonidazole, mercaptopurine, Entocort, and, most recently, infliximab. In September 2004, the patient underwent a small bowel resection and stricturoplasty and the specimen was examined by the pathologist who thought this again represented active Crohn’s disease. Although the patient had some initial response to infliximab, the response has waned with time. Citing theoretical reasons including antibody production to this agent, the enrollee and his providers have requested that the Health Plan approve adalimumab (Humira) as treatment for Crohn’s disease.

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with Crohn’s disease. In an undated letter, the provider noted that the patient has ileocolonic and perianal Crohn's disease, status post subtotal colectomy and end-ileostomy. Per the provider, an ileostomy revision was performed due to abscess and fistula. The patient has tried and failed multiple medications, including Humira, Remicade, 6-mercaptopurine, and methotrexate. The patient was noted to have had a response to Tysabri, but this medication was stopped after the patient moved abroad. The patient also tried and failed treatment with Entyvio. The patient began treatment with Stelara. The provider noted that an ileoscopy in November showed active Crohn’s disease in the distal ileum.

Where the denial was upheld

Physician 1The patient is a 45-year-old man who was diagnosed with Crohn’s disease in 1988. In addition to bowel manifestations, the patient has experienced pyoderma gangrenosum. He has undergone treatment with Rowasa enemas, sulfasalazine, 6-MP, and Remicade. A diverting ileostomy was performed because of colitis from the rectum to the hepatic flexure with a rectal stricture and anal fistula. The patient has requested authorization for treatment under a protocol for stem cell transplantation after immune ablation. The Health Plan has denied authorization for the requested procedure on the basis that it is considered experimental.The requested procedure is unproven and is being conducted under institutional IRB approval. The technique is a radical departure from standard treatments, and involves a substantial risk of morbidity and mortality.

Physician 1: The patient is a 19-year-old male who consulted his gastroenterologist for a second opinion regarding his diagnosis and treatment of Crohn’s disease. The disease is said to involve the terminal ileum by small bowel x-ray. The patient had previously been found to have perianal swelling, though the only note regarding the physical examination indicates a rectal exam was deferred. At the time of the second opinion the patient was taking Asacol, Flagyl, Imuran (azathioprine), and prednisone. The gastroenterologist recommended the patient undergo Prometheus-PRO-Predict TPMT Genetics testing. The Health Plan has declined coverage for this test on the basis that there is insufficient scientific evidence demonstrating how 6-MP genotype analysis will impact the patient’s management or clinical outcomes. At issue in this case is the clinical utility of TPMT testing.

Fighting a denial for an IBD biologic — Humira, Skyrizi, Stelara, Entyvio, Remicade, Rinvoq? We wrote the full playbook: Crohn’s & colitis biologic denial evidence guide.

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 crohn's disease, then check the rights and deadlines that apply to your plan.