Digestion GI Rx denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient is a 13-year-old female with a diagnosis of irritable bowel syndrome-constipation subtype. She also has a history of dysautonomia and vasovagal syncope, dizziness, and postural orthostatic tachycardia syndrome. The medical records note the patient has struggled with constipation since she was six months of age and has been treated with MiraLAX since that time. An esophagogastroduodenoscopy (EGD) and colonoscopy in showed focal active ileitis with a single ill-defined granuloma. A magnetic resonance elastography (MRE) in was noted to be normal. The patient was treated with budesonide for a couple months, but symptoms persisted/worsened. Despite MiraLAX, one cap daily, the patient was noted to have bowel movements from twice daily to (more commonly) once weekly. She also takes senna as needed. Imaging showed moderate constipation.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for increasing the dosage of the medication, budesonide. Muir and Falk describe eosinophilic esophagitis as an immune-mediated chronic esophageal disorder that is diagnosed using both clinical and pathologic information. Patients commonly have high rates of concurrent allergic diseases, especially food sensitization, compared with the general population. Standard therapies for eosinophilic esophagitis include dietary modification, acid suppression using PPIs, topical fluticasone, topical budesonide, and dilatation for esophageal stricture. Swallowed topical-acting corticosteroids are effective in bringing active eosinophilic esophagitis into remission. The U.S. Food and Drug Administration (FDA) designates budesonide as an orphan drug for the treatment of eosinophilic esophagitis.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parents of the patient requested Inflectra® infusions to be administered at a site that is part of a hospital (hospital outpatient facility infusion center).Inflammatory bowel disease (IBD) therapy often requires biologic medications delivered by intravenous infusion. Fenster and colleagues indicated that intravenous infusions of infliximab in patients with IBD are routinely delivered under the direct supervision of clinicians in infusion centers at both hospitals and clinics. Hospital-based infusions are not proven to be safer or more effective than those provided outside the hospital setting (Polinski et al.). The authors concluded that patients receiving infusions outside the hospital setting were no more likely to experience adverse drug events or side effects and had as good or better clinical outcomes.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for Pentasa. 5-aminosalicylates (5-ASA) act as topical anti-inflammatory agents that have efficacy within the lumen of the intestine. Although the use of 5-ASA for the treatment of ulcerative colitis is well established and evidence-based, Atia and colleagues explain, “5-ASA are widely used in Crohn's disease (CD) despite guidelines advising otherwise.” The American College of Gastroenterology guidelines on the management of Crohn’s disease notes that oral mesalamine has not consistently been demonstrated to be effective compared with placebo for the induction of remission and for achieving mucosal healing in patients with active Crohn's disease.

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 Digestion GI Rx, then check the rights and deadlines that apply to your plan.