Ulcerative Colitis denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Renflexis infusions every four weeks at a hospital infusion center. Renflexis is U.S. Food and Drug Administration (FDA) approved for the treatment of patients with ulcerative colitis. A dosage of Renflexis every four weeks is commonly used during maintenance therapy and has shown to be effective. The American College of Gastroenterology (ACG) guidelines for the management of ulcerative colitis also support an increase in Renflexis dosage for patients with uncontrolled disease. In this case, the patient presents with clinically uncontrolled ulcerative colitis, which places her at risk for disease complications such as toxic megacolon, another hospitalization, need for surgery, and colorectal cancer.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for proton radiation therapy and SpaceOAR treatment in conjunction with the proton radiation therapy. The Health Plan has denied this request indicating that the requested services are not medically necessary for treatment of the patient’s prostate cancer. The submitted documentation supports the medical necessity of a portion of the requested services. Currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. A Surveillance, Epidemiology and End Results (SEER)-Medicare analysis evaluated the comparative effectiveness of intensity-modulated radiation therapy (IMRT,) proton therapy, and conformal radiation therapy for prostate cancer.

Where the denial was upheld

Physician 1This is a patient with apparent left-sided chronic ulcerative colitis who has continued symptoms despite topical and systemic therapy with mesalamine preparations. She is said to have been unresponsive to corticosteroids in the past; however, a review of the medical records provided documents no use of prednisone or other corticosteroids since at least the fall of 2003. Imuran was started in September 2003. The treatment notes from December 2003 indicate the patient was in remission and away from steroids. The patient was no longer on Imuran when she presented with a flare-up of her disease in March 2004, which may be an indication the patient will respond to immunomodulator therapy if maintained on the drug. The treatment notes suggest the patient might have had trouble with nausea while on Imuran but this is not clearly documented.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the measurement of serum tumor necrosis factor (TNF) agents and anti-drug antibodies chemistry testing for evaluation of the enrollee’s ulcerative colitis. Findings: 2/3 of the physician reviewers found that In this case, measurement of serum TNF agents and anti-drug antibodies chemistry testing was recommended to determine the patient’s Remicade level, and whether antibodies to Remicade were present. Loss of response to Remicade can occur for many reasons, although there was not a clear loss of response to Remicade in this case. The presence of antibodies alone has not been demonstrated to result in loss of response to infliximab or infusion reactions, nor have threshold levels been established.

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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 ulcerative colitis, then check the rights and deadlines that apply to your plan.