Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Shoemaker Protocol including office visit with qualified provider experienced with the Shoemaker Protocol once every four to six weeks until the Shoemaker Protocol is completed; Welchol 625 mg; liposomal vitamin C 500 mg; vasoactive intestinal peptide nasal spray; epinastine HCL 0.05% two drops twice daily; neuroquadrant magnetic resonance imaging (MRI) without contrast; macron biofilm analysis; nares culture; Singulair 10 mg once daily; Cromolyn 4 ampules twice daily; and cholestyramine non-saccharine 4 grams. CRIS is a controversial constellation of symptoms, which is not currently accepted as a diagnostic disorder. Mast cell activation syndrome is a recent diagnosis of signs and symptoms related to mast cell release to include urticaria, angioedema, headache, and abdominal pain, as well as fatigue and memory issues. The current recommended therapy includes treatment to inhibit mast cell release and blocking symptoms. Histamine 1 (H1) and histamine 2 (H2) blockers are first-line therapy followed by leukotriene receptor blockers and Cromolyn sodium. This patients records do not document that he has failed treatment, or has a contraindication to H1 and H2 blockers. Therefore, the requested Shoemaker Protocol including office visit with qualified provider experienced with the Shoemaker Protocol once every four to six weeks until the Shoemaker Protocol is completed; Welchol 625 mg; liposomal vitamin C 500 mg; vasoactive intestinal peptide nasal spray; epinastine HCL 0.05% two drops twice daily; neuroquadrant magnetic resonance imaging (MRI) without contrast; macron biofilm analysis; nares culture; Singulair 10 mg once daily; Cromolyn 4 ampules twice daily; and cholestyramine non-saccharine 4 grams, are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the requested Shoemaker Protocol including office visit with qualified provider experienced with the Shoemaker Protocol once every four to six weeks until the Shoemaker Protocol is completed; Welchol 625 mg; liposomal vitamin C 500 mg; vasoactive intestinal peptide nasal spray; epinastine HCL 0.05% two drops twice daily; neuroquadrant magnetic resonance imaging (MRI) without contrast; macron biofilm analysis; nares culture; Singulair 10 mg once daily; Cromolyn 4 ampules twice daily; and cholestyramine non-saccharine 4 grams, are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: The reviewers determined that the requested services and medications are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in internal medicine with subspecialty certification in allergy and immunology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.