Medically Necessary Small-Bowel Wireless Capsule Endoscopy
Wireless capsule endoscopy of the small bowel may be considered medically necessary when at least one covered indication is met.
ONE or more of the following
Evaluation of suspected small bowel bleeding when prior upper and lower gastrointestinal endoscopic studies performed during the current episode of illness are inconclusive and clinical documentation of suspected gastrointestinal bleeding is provided, including anemia (such as iron-deficiency anemia), a positive fecal occult blood test, or visible bleeding.
Evaluation of Crohn's disease in an established diagnosis when there are unexpected changes in the course of disease or response to treatment suggesting that the initial diagnosis may be incorrect and reexamination may be indicated.
Initial diagnosis of suspected Crohn's disease when clinical documentation shows abdominal pain or diarrhea plus at least one sign of inflammation, such as fever, elevated white blood cell count, elevated erythrocyte sedimentation rate, elevated C-reactive protein, bleeding, terminal ileitis, or another nondiagnostic inflammatory finding, and the diagnosis has not been confirmed by conventional diagnostic tests.
Small-bowel surveillance in patients with hereditary gastrointestinal polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.
Evaluation of celiac disease when there is clinical evidence of celiac disease and positive celiac-specific serology but upper endoscopy with biopsy is not indicated, or re-evaluation of celiac disease in an individual who remains symptomatic despite treatment.
Investigational Uses and Technologies
Wireless capsule endoscopy is investigational when the medically necessary criteria are not met and for the following indications and technologies.
Investigational indications and technologies
Small-bowel evaluation not meeting the medically necessary criteria.
Evaluation of the extent of known Crohn's disease or ulcerative colitis.
Evaluation of the esophagus, including gastroesophageal reflux and other esophageal pathologies.
Evaluation of gastrointestinal diseases and conditions not presenting with gastrointestinal bleeding, including irritable bowel syndrome, hereditary nonpolyposis syndromes such as Lynch syndrome, small-bowel neoplasm, portal hypertensive enteropathy, and unexplained chronic abdominal pain.
Evaluation of the colon, including detection of colonic polyps or colon cancer.
Suspected Small Bowel Bleeding
For suspected small-bowel bleeding, wireless capsule endoscopy is intended to confirm the diagnosis and inform a decision to proceed to appropriate treatment.
ALL of the following
The individual has recurrent or obscure gastrointestinal bleeding with suspected small-bowel bleeding.
Prior upper and lower gastrointestinal endoscopic studies performed during the current episode of illness are inconclusive.
Clinical documentation of suspected gastrointestinal bleeding is provided, including anemia, a positive fecal occult blood test, or visible bleeding.
The examination is used to locate the bleeding source and direct treatment to that source.
Established Crohn's Disease
For established Crohn's disease, wireless capsule endoscopy is intended to inform management decisions based on disease status.
ALL of the following
Crohn's disease has been previously diagnosed.
There is an unexpected change in the course of disease or response to treatment suggesting that the initial diagnosis may be incorrect or that reexamination is indicated.
The results will inform management decisions based on current disease status.
Suspected Crohn's Disease
For suspected Crohn's disease, wireless capsule endoscopy is intended to confirm a diagnosis and inform a decision to proceed to appropriate treatment.
ALL of the following
Clinical documentation shows abdominal pain or diarrhea plus at least one sign of inflammation, such as fever, elevated white blood cell count, elevated erythrocyte sedimentation rate, elevated C-reactive protein, bleeding, terminal ileitis, or another inflammatory finding that is nondiagnostic on conventional tests.
The diagnosis has not been confirmed by conventional diagnostic tests, which may include small-bowel follow-through, upper and lower endoscopy, MR enterography, or CT enterography.
The examination is being performed to confirm the diagnosis and inform treatment planning.
Celiac Disease
Wireless capsule endoscopy may be considered medically necessary for celiac disease in the following circumstances.
ONE of the following
Clinical evidence of celiac disease and positive celiac-specific serology when upper endoscopy with biopsy is not indicated.
Re-evaluation of an individual with celiac disease who remains symptomatic despite treatment.
Unexplained Chronic Abdominal Pain
The purpose of wireless capsule endoscopy for unexplained chronic abdominal pain is to confirm a diagnosis and inform a decision to proceed to appropriate treatment.
ALL of the following
The individual has unexplained chronic abdominal pain.
The examination is intended to confirm a diagnosis and inform treatment.
The sequence and chronology of testing and treatment before capsule endoscopy have been adequately defined to establish clinical utility.
Ulcerative Colitis
The purpose of wireless capsule endoscopy for ulcerative colitis would be to inform management decisions based on disease status.
ALL of the following
The individual has ulcerative colitis.
The examination is intended to assess disease status and inform management decisions.
Hereditary Gastrointestinal Polyposis Syndromes
Wireless capsule endoscopy may be considered medically necessary for small-bowel surveillance in hereditary gastrointestinal polyposis syndromes.
Applicable syndromes
Familial adenomatous polyposis.
Ulcerative Colitis: Evidence Limitations
Evidence for wireless capsule endoscopy in ulcerative colitis is limited.
ALL of the following
Diagnostic-accuracy studies have compared capsule endoscopy with colonoscopy for disease activity, but data are limited; two of four studies included fewer than 50 patients.
No randomized controlled trials assessing the clinical utility of wireless capsule endoscopy for ulcerative colitis were identified.
Additional evidence is needed to determine the impact on net health outcomes.
Esophageal Disorders
Other available modalities are superior to wireless capsule endoscopy for monitoring esophageal disorders.
ALL of the following
Wireless capsule endoscopy has generally demonstrated inferior diagnostic characteristics compared with traditional upper endoscopy for esophageal conditions.
Wireless capsule endoscopy cannot substitute for traditional endoscopy or triage patients to endoscopy because of inadequate sensitivity and specificity.
Portal Hypertensive Enteropathy
Capsule endoscopy has been used to diagnose portal hypertensive enteropathy, but its diagnostic performance and clinical utility are limited.
ALL of the following
Systematic reviews report limited sensitivity and specificity for the relevant findings.
Capsule endoscopy should not be used instead of esophagogastroduodenoscopy or to triage patients to esophagogastroduodenoscopy.
The available diagnostic characteristics do not demonstrate clinical utility.
Acute Upper Gastrointestinal Tract Bleeding
The purpose of wireless capsule endoscopy for acute upper gastrointestinal tract bleeding would be to inform management decisions based on disease status.
ALL of the following
The individual has acute upper gastrointestinal tract bleeding.
The examination is intended to inform management decisions based on disease status.
Because evidence is insufficient and guidelines do not recommend this use, the examination is investigational.
Colon Cancer Screening
The purpose of wireless capsule endoscopy for colon cancer screening would be to confirm a diagnosis and inform a decision to proceed to appropriate treatment.
ALL of the following
The individual is being screened for colon cancer.
The examination is intended to confirm a diagnosis and inform treatment.
The use is investigational because evidence is insufficient and diagnostic performance is worse than standard colonoscopy.
Lower Gastrointestinal Tract Bleeding and Major Risks for Colonoscopy or Moderate Sedation
Wireless capsule endoscopy for lower gastrointestinal bleeding in individuals at major risk for colonoscopy or moderate sedation is investigational.
ALL of the following
There is evidence of gastrointestinal bleeding of lower gastrointestinal origin.
The individual has major risks for colonoscopy or moderate sedation.
The proposed purpose is to visualize the colon for polyps or another source of bleeding and guide further treatment or testing.
Suspected Small-Bowel Bleeding: Required Criteria
Wireless capsule endoscopy may be considered medically necessary for suspected small-bowel bleeding when all of the following are met.
ALL of the following
The individual has recurrent, obscure gastrointestinal bleeding with suspected small-bowel bleeding.
Prior upper and lower gastrointestinal endoscopic studies are inconclusive.
The examination can locate the source of bleeding and direct treatment to that source.
Crohn's Disease: Qualifying Scenarios
Wireless capsule endoscopy may be considered medically necessary for Crohn's disease in either of the following scenarios.
ONE of the following
Initial diagnosis of suspected small-bowel Crohn's disease when clinical signs are present and conventional diagnostic tests do not show the disease.
Established Crohn's disease with unexpected changes in disease course or response to treatment.
Hereditary GI Polyposis Syndromes: Qualifying Criteria
Wireless capsule endoscopy may be considered medically necessary for small-bowel surveillance in hereditary gastrointestinal polyposis syndromes.
Qualifying syndromes
Familial adenomatous polyposis.
Suspected Crohn's Disease: Initial Diagnosis
Initial diagnosis of suspected Crohn's disease requires all of the following.
ALL of the following
Clinical documentation of abdominal pain or diarrhea plus at least one sign of inflammation.
The diagnosis has not been confirmed by conventional diagnostic tests, such as small-bowel follow-through, upper and lower endoscopy, MR enterography, or CT enterography.
The examination is intended to confirm the diagnosis and inform treatment planning.
Established Crohn's Disease: Unexpected Change
In established Crohn's disease, wireless capsule endoscopy may be considered medically necessary when the clinical course or treatment response changes unexpectedly.
ALL of the following
Crohn's disease has been established by prior diagnosis.
There is an unexpected change in the course of disease or response to treatment.
The examination is needed to reassess disease status and inform management.
Hereditary GI Polyposis Syndromes: Medical Necessity
Wireless capsule endoscopy may be considered medically necessary for hereditary gastrointestinal polyposis syndromes when used for small-bowel surveillance.
ALL of the following
The individual has familial adenomatous polyposis, Peutz-Jeghers syndrome, or another qualifying hereditary gastrointestinal polyposis syndrome.
The examination is performed for small-bowel surveillance.
Celiac Disease: Diagnostic or Reassessment Criteria
Wireless capsule endoscopy may be considered medically necessary for celiac disease in either of the following circumstances.
ONE of the following
Clinical evidence of celiac disease and positive celiac-specific serology in an individual unable to undergo upper endoscopy with biopsy.
Re-evaluation of an individual with celiac disease who remains symptomatic despite treatment.
Gastrointestinal tract obstruction is a contraindication because the capsule may fail to pass and may require surgical removal. Individuals at risk for obstruction require careful specialist evaluation before the procedure.
Wireless capsule endoscopy cannot replace upper endoscopy or be used to triage patients to upper endoscopy. Other available modalities are superior for esophageal evaluation.
For portal hypertensive enteropathy or suspected esophageal varices, wireless capsule endoscopy should not be used instead of esophagogastroduodenoscopy or to triage patients to esophagogastroduodenoscopy because diagnostic performance is limited and clinical utility has not been demonstrated.
Routine small-bowel surveillance with wireless capsule endoscopy is not generally recommended for individuals with Lynch syndrome. Evidence is insufficient to establish that surveillance improves outcomes.
Wireless capsule endoscopy cannot substitute for esophagogastroduodenoscopy or triage patients to esophagogastroduodenoscopy when evaluating portal hypertension, esophageal varices, or other upper gastrointestinal disorders.
Wireless capsule endoscopy is contraindicated when small-bowel obstruction or stricture is known or suspected because the capsule may not pass naturally and may require surgical removal.
Routine wireless capsule endoscopy is not indicated for surveillance.
Wireless capsule endoscopy is not the preferred initial workup for suspected small-bowel adenocarcinoma because it cannot obtain tissue for diagnosis. It may be considered only after radiographic imaging and other forms of endoscopy fail to reveal a suspected primary lesion.
Evaluation of the esophagus with wireless capsule endoscopy, including for gastroesophageal reflux or other esophageal pathologies, is investigational.
Wireless capsule endoscopy is investigational for nonqualifying gastrointestinal conditions, including irritable bowel syndrome, hereditary nonpolyposis syndromes such as Lynch syndrome, small-bowel neoplasm, portal hypertensive enteropathy, lower gastrointestinal bleeding, incomplete colonoscopy, and unexplained chronic abdominal pain.
Wireless capsule endoscopy is investigational for colon cancer screening because evidence is insufficient to show improved health outcomes and diagnostic performance is worse than standard colonoscopy.
Wireless capsule endoscopy is investigational for acute upper gastrointestinal tract bleeding because evidence is insufficient to show improved health outcomes and clinical guidelines do not recommend this use.
Patency capsules are investigational for all indications, including evaluation of gastrointestinal tract patency before wireless capsule endoscopy. Evidence does not establish improved net health outcomes compared with other strategies, and adverse events may include small-bowel obstruction and perforation.
Magnetic capsule endoscopy is investigational for all indications because research has not shown improved health outcomes and no evidence-based clinical guidelines recommend it.
An upper gastrointestinal optical sensor capsule, including the PillSense System, is investigational for all indications because research has not shown improved health outcomes and evidence-based clinical guidelines do not recommend it.
Wireless capsule endoscopy for small-bowel evaluation is investigational when the medically necessary criteria are not met.
Wireless capsule endoscopy is investigational for nonqualifying esophageal evaluation, colon evaluation or screening, acute upper gastrointestinal bleeding, lower gastrointestinal bleeding, and evaluation following incomplete colonoscopy.
Portal hypertensive enteropathy lacks demonstrated clinical utility because diagnostic sensitivity and specificity are limited. Wireless capsule endoscopy should not replace or triage to esophagogastroduodenoscopy.
Routine small-bowel surveillance is not generally recommended for Lynch syndrome because available evidence is insufficient regarding lesion prevalence, natural history, and improved patient outcomes.
The American Gastroenterological Association recommends against using capsule endoscopy to diagnose Crohn's disease when chronic abdominal pain or diarrhea are the only symptoms and there is no evidence of biomarkers.
The American Gastroenterological Association recommends against using capsule endoscopy for diagnosing celiac disease.
The American Gastroenterological Association recommends against routine substitution of capsule endoscopy for colonoscopy and against using capsule endoscopy as a substitute for colonoscopy to assess the extent or severity of inflammatory bowel disease.