Irritable Bowel denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Linzess capsules. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s chronic idiopathic constipation. A review of the records indicates that the enrollee has been diagnosed with chronic idiopathic constipation, gastroesophageal reflux disease with esophagitis, with a history of anorexia. The records indicated ongoing constipation issues despite referral to the registered dietician and eating disorder coach, as well as use of fiber, Colace, and administration of enemas several times per week. The enrollee is noted to have adequate hydration and activity level.The submitted documentation supports the medical necessity of the requested medication.

The patient is a 36-year-old female with constipation predominant irritable bowel syndrome (IBS). Although the patient has responded to therapy with Zelnorm, she quickly relapses once therapy is discontinued. Relapse of her IBS has resulted in painful perianal disease that has required surgery in the past. The Health Plan has denied authorization for Zelnorm therapy on the basis that it is not medically necessary for treatment of the patient’s IBS.Though it has been suggested that the Food and Drug Administration (FDA) has approved the use of Zelnorm for 4-6 weeks with one repeat, the FDA actually suggests that therapy for 12 weeks should be considered in those patients who respond by 4-6 weeks. The FDA approval never discusses repeat dosing. Furthermore, labeled indications for any drug do not necessarily reflect standard of care or prudent use.

Where the denial was upheld

Physician 1: This patient is a 54-year-old female who has irritable bowel syndrome, constipation predominant subtype (IBS-C) and apparently was tested for small bowel bacteria with positive results. Her treating physician is now recommending treatment with a recently described antimicrobial regimen of Xifaxan and neomycin in an effort to resolve her bacterial overgrowth and symptoms of IBS-C. The Health Plan has denied coverage for Xifaxan on the basis it is considered investigational for treatment of the patient’s medical condition.The issue of the prevalence and putative association of small intestinal bacterial overgrowth with IBS and functional dyspepsia have been and remain controversial.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the amount of a type of drug (tumor necrosis factor antagonists (TNF)) in the blood for evaluation of the enrollee’s inflammatory bowel disease (IBD). Findings: The physician reviewer found that There is not currently sufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management this patient’s medical condition. The published studies on the use of anti-adalimumab antibodies and serum levels are small, retrospective, and/or observational rather than controlled in nature, preventing firm conclusions about cause and effect. These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect.

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 irritable bowel, then check the rights and deadlines that apply to your plan.