Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 60-year-old woman with Crohns disease who was recently diagnosed with active mucosal disease of her small bowel by capsule endoscopy. She was subsequently treated with steroids and Remicade to induce remission. She has requested authorization and coverage for another capsule study to assess disease activity. The submitted records indicate she currently has few if any symptoms suggestive of active Crohns disease. The Health Plan has denied coverage for the requested endoscopy on the basis it is considered investigational for evaluation of the patients condition. While capsule endoscopy has been shown to be a sensitive test for diagnosing Crohns disease and has gained widespread acceptance as an initial diagnostic test in this regard, there are no data justifying its use as a tool to guide therapeutic decisions. Furthermore, the concept of using imaging of any type (radiographic or endoscopic) to guide therapy in patients with Crohns disease is not an accepted practice. Symptoms drive initial management, and once symptoms are controlled, routine use of maintenance therapy is the norm. This is the case regardless of macroscopic disease activity (which commonly is still present but is not the central issue). The use of repeat capsule endoscopy to assess mucosal activity in the absence of uncontrolled disease has not been studied at this time and cannot be justified outside of clinical studies. Based upon the information set forth above, I have determined that the requested procedure is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 2: The patient is a 60-year-old woman with Crohns disease who is requesting authorization for serial capsule endoscopy to evaluate treatment response to medications for this problem. Her request has been denied by the Health Plan on the basis that the requested use of capsule endoscopy is considered experimental. Capsule endoscopy is a technique for visualizing the small intestinal mucosa with a swallowed video capsule, which transmits images to a radiofrequency receiver worn by the patient during the examination. It has gained some acceptance as an aid to diagnosis of gastrointestinal bleeding of obscure origin after negative esophagogastroduodenoscopy (EGD), colonoscopy, and small bowel follow-through examination. It has also been proposed as a method for diagnosis of Crohns disease in the rare Crohns patient who has a completely normal colonoscopy and small bowel follow-through exam.An initial case series of 17 male and female patients with suspected Crohns was reported investigating the use of capsule endoscopy (Fireman, et al). The patients had iron deficiency anemia, abdominal pain or diarrhea. They had undergone small bowel x-ray and colonoscopy without definitive diagnosis. In this group of patients, 71% had findings suggestive of Crohns disease. A case series of 21 patients with suspected Crohns disease showed similar results (Cave). All had clinical suspicion of Crohns disease with conventional imaging including EGD, colonoscopy, and small bowel follow-through. Capsule endoscopy was normal in 53%; 43% had lesions suspicious for Crohns disease. The most frequent findings were aphthae and ulcerations in the distal ileum. The only blinded comparison of capsule endoscopy to small bowel follow-through examination has thus far showed similar sensitivity with the two techniques. Further, the incidence of small bowel erosions in normal persons in the general population has not been determined so the utility of this technique remains open to discussion at this time. In the case of this patient, however, there is not a question of Crohns disease as the diagnosis and her disease is equivocal on the basis of a long history and operative findings. Crohns disease is not routinely managed by serial endoscopy, conventional or otherwise. The poor correlation between symptoms and endoscopic findings is the reason that instruments such as the Crohns Disease Activity Index or c-reactive protein assays are employed in clinical research and less formal assessments are utilized in daily clinical practice. There is insufficient evidence to support routine endoscopy as a way to follow treatment response in Crohns disease and none to support the use of capsule endoscopy for this purpose. Therefore, there is no evidence that capsule endoscopy is likely to be superior to conventional modalities for evaluation and management of this patients condition.Accordingly, I have determined that the requested procedure is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 3: The patient is a 60-year-old female with Crohns disease. A capsule endoscopy in September 2004 showed evidence of small bowel disease. A repeat procedure is being requested to see if there is any further evidence of inflammation in the small bowel. There are no reported symptoms. The Health Plan has denied coverage for the requested procedure on the basis that its efficacy in this clinical setting has not been shown. There are no published, peer-reviewed studies showing there is benefit in surveillance capsule endoscopy.  The patients disease has already been diagnosed with a capsule endoscopy. Repeating the test in the absence of symptoms is not medically indicated and is not likely to be of clinical benefit. Therefore, I have determined that the requested procedure is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.