Medical policy: Wireless Capsule Endoscopy for Gastrointestinal Disorders

Policy number: MP 5.033

Effective date: 11/1/2026

Policy

Wireless capsule endoscopy (CE) of the small bowel may be considered medically necessary for the following indications:

• Suspected small bowel bleeding, as evidenced by prior inconclusive upper and lower gastrointestinal (GI) endoscopic studies performed during the current episode of illness.
• Initial diagnosis in individuals with suspected Crohn’s disease without evidence of disease on conventional diagnostic tests such as small bowel follow-through and upper and lower endoscopy.
• In individual with an established diagnosis of Crohn’s disease, when there are unexpected change(s) in the course of disease or response to treatment, suggesting the initial diagnosis may be incorrect and re-examination may be indicated.
• For surveillance of the small bowel in individuals with hereditary gastrointestinal (GI) polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.

Other indications for wireless capsule endoscopy are considered investigational as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Other indications including, but not limited to:

• Evaluation of the extent of involvement of known Crohn’s disease or ulcerative colitis
• Evaluation of the esophagus, in individuals with gastroesophageal reflux (GERD) or other esophageal pathologies
• Evaluation of other GI diseases and conditions not presenting with GI bleeding, including but not limited to, celiac sprue, irritable bowel syndrome, Lynch syndrome (risk for hereditary nonpolyposis colorectal cancer), portal hypertensive enteropathy, small bowel neoplasm, and unexplained chronic abdominal pain.
• Evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer.
• Initial evaluation of individuals with acute upper GI bleeding
• Evaluation of individuals with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation
• Evaluation of individuals following incomplete colonoscopy

The patency capsule is considered investigational, including use to evaluate patency of the GI tract before wireless capsule endoscopy. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

Magnetic capsule endoscopy is considered investigational for the evaluation of individuals with unexplained upper abdominal complaints and all other indications. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Description/Background

The wireless capsule endoscopy uses a noninvasive device to visualize segments of the gastrointestinal (GI) tract. Patients swallow a capsule that records images of the intestinal mucosa as it passes through the GI tract.

Health and health outcome disparities in certain populations

Screening for colon cancer is suboptimal in the U.S., with only 68.8% of Americans age 50 to 75 years up to date with colorectal cancer screening as of 2018. Additionally, screening rates vary considerably by race, ethnicity, and socioeconomic status in the U.S, with highest rates of screening occurring in White Americans (71.1%) and the lowest rates of screening among Hispanic Americans (56.1%). Black Americans (70.1%), American Indian/Native Americans (62.1%), and Asian Americans/Pacific Islanders (64.8%) have lower screening rates than White Americans. These disparities seem to be associated with limited access to care, a lack of knowledge on family history, and adverse social determinants of health.

As of 2018, the mortality rate for colorectal cancer had decreased by 53% among men and by 30% in women since 1990 and 1969, respectively. However, colorectal cancer incidence and mortality rates vary between racial and ethnic groups. Between 2012 and 2016, reported incidence rates were highest in non-Hispanic Black individuals, accounting for 45.7 per 100,000 population, and lowest in Asian/Pacific Islander individuals, accounting for 30.0 per 100,000 population. The magnitude of disparity is more evident in mortality rates. Colorectal cancer death rates in non-Hispanic Black individuals (19.0 per 100,000 population) between 2013 and 2017 were nearly 40% higher than those in non-Hispanic White individuals (13.8 per 100,000) and twice that of Asian/Pacific Islander individuals (9.5 per 100,000). Disparities have been attributed to many socioeconomic and social determinants of health, including low median family income, higher prevalence of risk factors, and lower rates of screening and likelihood of timely follow-up.

Wireless capsule endoscopy

Wireless capsule endoscopy is performed using the PillCam Given Diagnostic Imaging System (previously called M2A), which is a disposable imaging capsule manufactured by Given Imaging. The capsule measures 11 by 30 mm and contains video imaging, self-illumination, and image transmission modules, as well as a battery supply that lasts up to 8 hours. The indwelling camera takes images at a rate of 2 frames per second as peristalsis carries the capsule through the gastrointestinal tract. The average transit time from ingestion to evacuation is 24 hours. The device uses wireless radio transmission to send the images to a receiving recorder device that the patient wears around the waist. This receiving device also contains some localizing antennae sensors that can roughly gauge where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.

Capsule endoscopy has been proposed as a method for identifying Crohn disease. There is no single criterion standard diagnostic test for Crohn disease; rather, diagnosis is based on a constellation of findings. Thus, it is difficult to determine the diagnostic characteristics of various tests used to diagnose the condition and difficult to determine a single comparator diagnostic test to CE.

Magnetic capsule endoscopy

The U.S. Food and Drug Administration (FDA) approved a novel magnetically maneuvered CE system (NaviCam™; AnX Robotica, Inc.) in May 2020. This system consists of a single-use ingestible capsule and magnet linked to a physician-operated console. The capsule contains a camera that wirelessly captures images of the desired anatomy. The console allows the operator to control the motion and direction of the capsule, ensuring visualization of the entire stomach. The system is non-invasive, does not require sedation, and has a procedural time of approximately 15 to 20 minutes. The capsule leaves the body in 24 hours on average but may take as long as 2 weeks. The device is contraindicated for use in patients with gastrointestinal obstruction, stenosis, fistula, or those with dysphagia. Other contraindications include patients with cardiac pacemakers or other implantable electronic medical devices as well as pregnant women, those less than 22 years of age, and those with a body mass index of 38 or greater.

Regulatory status

Table 1 summarizes various wireless CE devices with clearance by the U.S. Food and Drug Administration.

Code used: NEZ

Table 1. Wireless capsule endoscopy devices cleared by the U.S. Food and Drug Administration

GI: gastrointestinal.

Rationale

Summary of evidence

Patients with suspected GI disorders

For individuals who have suspected small bowel bleeding (previously referred to as obscure GI bleeding) who receive wireless CE, the evidence includes numerous case series evaluating patients with a non-diagnostic standard workup and a randomized control trial (RCT). Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. The evidence has demonstrated that CE can identify a bleeding source in a substantial number of patients who cannot be diagnosed by other methods, with a low incidence of adverse events. Because there are few other options for diagnosing obscure small bowel bleeding in patients with negative upper and lower endoscopy, this technique will likely improve health outcomes by directing specific treatment when a bleeding source is identified. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have suspected small bowel Crohn disease (CD) who receive wireless CE, the evidence includes case series. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. Although the test performance characteristics and diagnostic yields of the capsule for this indication are uncertain, the diagnostic yields are as good as or better than other diagnostic options, and these data are likely to improve health outcomes by identifying some cases of CD and directing specific treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have suspected celiac disease who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. The diagnostic characteristics of CE are inadequate to substitute for other modalities or to triage patients to other modalities. For other conditions (e.g., determining the extent of CD), direct evidence of improved outcomes or a strong indirect chain of evidence to improved outcomes or a strong indirect chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have unexplained chronic abdominal pain who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. The diagnostic characteristics of CE are inadequate to substitute for other modalities or to triage patients to other modalities. For other conditions (e.g., determining the extent of CD), direct evidence of improved outcomes or a strong chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Patients with confirmed GI disorders

For individuals who have an established diagnosis of CD who receive wireless CE, the evidence includes diagnostic accuracy studies, a systematic review, and a retrospective cohort study. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. A 2017 systematic review of 11 studies in patients with established CD found a similar diagnostic yield with CE and with radiography. Because there is evidence that the diagnostic yields are as good as or better than other diagnostic options, there is indirect evidence that CE is likely to improve health outcomes by identifying some cases of CD and directing specific treatment. A retrospective cohort study demonstrated therapeutic management changes based on CE results. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have ulcerative colitis who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. Several diagnostic accuracy studies have compared CE with colonoscopy to assess disease activity in patients with ulcerative colitis. Two of 3 studies were small (i.e., <50 patients) and thus data on diagnostic accuracy are limited. Direct evidence of improved outcomes and a strong chain of evidence to improved outcomes are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have esophageal disorders who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. Other available modalities are superior to CE. The diagnostic characteristics of CE are inadequate to substitute for other modalities or to triage patients to other modalities. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have hereditary GI polyposis syndromes who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. The data are insufficient to determine whether evaluation with CE would improve patient outcomes. Further information on the prevalence and natural history of small bowel polyps in Lynch syndrome patients is necessary. At present, surveillance of the small bowel is not generally recommended as a routine intervention for patients with Lynch syndrome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have portal hypertensive enteropathy who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. Relevant outcomes are test validity, and other test performance measures, symptoms, and change in disease status. Systematic reviews of studies of CE’s diagnostic performance for this indication have reported limited sensitivity and specificity. Due to insufficient data on diagnostic accuracy, a chain of evidence on clinical utility cannot be constructed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Acute upper gastrointestinal bleeding

For individuals who have acute upper GI tract bleeding who receive wireless CE, the evidence includes randomized controlled trials (RCTs) and several cohort studies. Relevant outcomes are test validity, and other test performance measures, symptoms, hospitalizations, and resource utilization. The use of CE in the emergency department setting for suspected upper GI bleeding is intended to avoid unnecessary hospitalization or immediate endoscopy. Controlled studies are needed to assess further the impact of CE on health outcomes compared with standard management. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Colon cancer screening

For individuals who are screened for colon cancer who receive wireless CE, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, test validity, and other test performance measures. Studies of CE in screening populations are necessary to determine the diagnostic characteristics of the test in this setting. Studies of diagnostic characteristics alone are insufficient evidence to determine the efficacy of CE for colon cancer screening. Because diagnostic performance is worse than standard colonoscopy, CE would need to be performed more frequently than standard colonoscopy to have comparable efficacy. Without direct evidence of efficacy in a clinical trial of colon cancer screening using CE, modeling studies using established mathematical models of colon precursor incidence and progression to cancer could provide estimates of efficacy in preventing colon cancer mortality. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Lower GI tract bleeding and major risks for colonoscopy or moderate sedation

For individuals who are screened for colon polyps with evidence of lower GI tract bleeding and major risks for colonoscopy or moderate sedation who receive wireless CE, the evidence includes diagnostic accuracy studies. Relevant outcomes are test accuracy, test validity, other test performance measures, symptoms, change in disease status, and resource utilization. Studies of CE in the intended use population are necessary to determine the diagnostic characteristics of the test in the triage setting. Studies of diagnostic characteristics alone are insufficient evidence to determine the clinical utility of CE in this population, and no studies adequately assess the impact of findings on specific health outcomes or patient adherence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Incomplete colonoscopy

For individuals who are screened for colon polyps following an incomplete colonoscopy with adequate preparation who receive wireless CE, the evidence includes case series. Relevant outcomes are test accuracy, test validity, other test performance measures, symptoms, change in disease status, and resource utilization. Studies of CE compared to standard management with repeat colonoscopy in the intended use population are necessary to determine the diagnostic characteristics of the test in the triage setting. Studies of diagnostic characteristics alone are insufficient evidence to determine the clinical utility of CE in this population, and no studies adequately assess the impact of findings on specific health outcomes or patient adherence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Patency capsule for patients with bowel stricture

For individuals who are scheduled to undergo CE for known or suspected small bowel stricture who receive a patency capsule, the evidence includes case series. Relevant outcomes are test validity, symptoms, change in disease status, and treatment-related morbidity. The available studies have reported that CE following a successful patency capsule test results in high rates of success with low rates of adverse events. The capsule is also associated with adverse events. Because of the lack of comparative data to other diagnostic strategies, it is not possible to determine whether the use of the patency capsule improves the net health outcome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Magnetic capsule endoscopy for patients with suspected gastrointestinal disorders

For individuals who have unexplained upper abdominal complaints who receive magnetic CE, the evidence includes diagnostic accuracy studies. Relevant outcomes are test validity, symptoms, change in disease status, and treatment-related morbidity. Studies evaluating the diagnostic characteristics of magnetic CE as compared to conventional gastroscopy in the target population have generally demonstrated similar accuracy, sensitivity, and specificity, with increases in patient preference and an acceptable safety profile with the magnetic CE approach. However, the diagnostic characteristics of magnetic CE are inadequate to substitute for other modalities or to triage patients to other modalities based on the current literature. Direct evidence of improved outcomes or a strong chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Endoscopy refers to inspection of body organs or cavities by use of an endoscope.

510 (k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims.

Peristalsis refers to the progressive wavelike movement that occurs involuntarily in hollow tubes of the body, especially the alimentary canal.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered

Covered when medically necessary (91299 when used for patency capsule)

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