Commercial

Medical Policy

Notification

Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders

Notification Issue Date:

The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon.

Title:

Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders

Policy #:

07.05.02t

Policy

WIRELESS CAPSULE ENDOSCOPY (WCE) FOR VISUALIZATION OF THE SMALL BOWEL OR ESOPHAGEAL MUCOSA

Wireless capsule endoscopy (WCE) for visualization of the small bowel or esophageal mucosa using a US Food and Drug Administration (FDA)–approved device is considered medically necessary and, therefore, covered for any of the indications listed below:

OCCULT/OBSCURE GASTROINTESTINAL (GI) BLEEDING

Occult/obscure GI bleeding (defined as recurrent or persistent iron-deficiency anemia, positive fecal occult blood test, or visible bleeding with no bleeding source found) suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower GI endoscopy, push endoscopy, nuclear imaging, or radiological procedures.

Appropriate differential diagnoses for the evaluation of such bleeding include:

Angiodysplasia
Neoplasm
Iron deficiency anemia, which is unexplained after upper and lower endoscopy
Zollinger-Ellison syndrome
Tuberculosis
Vasculitis
Radiation enteritis
Meckel diverticulum
Jejunal diverticula
Chronic mesenteric ischemia

NOTE: Documentation must indicate that the individual has suspected GI blood loss with or without anemia.

SMALL BOWEL NEOPLASM

Detection of neoplasms of the small bowel, when the diagnosis has not been previously confirmed by any of the following: upper GI endoscopy, colonoscopy, push enteroscopy, nuclear imaging, or radiological procedures. The individual must also be symptomatic for a neoplasm (e.g., GI bleeding), have a documented hereditary GI polyposis syndrome (including familial adenomatous polyposis and Peutz-Jeghers) that is associated with small bowel neoplasia, or have other history suggesting the presence of small bowel neoplasia. Other diagnostic testing to assess these symptoms (i.e., upper GI endoscopy and/or colonoscopy) must have been performed.

CROHN DISEASE

For initial diagnosis in individuals with suspected, but unconfirmed, Crohn disease or for Crohn disease without evidence of the disease on a conventional diagnostic test, such as small bowel follow-through (SBFT) and upper and lower endoscopy.
In individuals with an established diagnosis of Crohn disease, when there are unexpected changes in the course of disease or response to treatment, suggesting the initial diagnosis may be incorrect and re-examination may be indicated.

EVALUATION PRIOR TO SURGERY

Evaluation of the extent of small bowel involvement with arteriovenous malformations or lymphangiectasia for individuals who are being considered for surgical resection of the small bowel to control recurrent bleeding or protein loss is appropriate.

EVALUATION OF ESOPHAGEAL VARICES

Evaluation of esophageal varices in individuals with cirrhosis and portal hypertension as an alternative to upper GI endoscopy

OTHER CONDITIONS

Evaluation of suspected or refractory malabsorption syndromes (e.g., celiac disease), chronic diarrhea, or protein-losing enteropathy of obscure origin when the condition is suspected to originate in the small intestinal mucosa. Prior negative or nondiagnostic evaluations of the esophagus, stomach, duodenum/small intestine, and colon by flexible endoscopy and complementary radiologic procedures and/or microbiologic studies must be documented.
In individuals in whom indeterminate type of colitis exists, but a more specific diagnosis is being sought via small bowel evaluation

LIMITATIONS
Typically, the administration of a second capsule would not be expected during the same examination, unless it was to ensure an adequate examination (e.g., the initial capsule does not penetrate the pylorus).

Any repeat use of the WCE for an individual must be considered medically necessary for coverage.

EXPERIMENTAL/INVESTIGATIONAL

WCE is considered experimental/investigational and, therefore, not covered for all other indications, including but not limited to the following:

Evaluation of the colon, including, but not limited to, detection of colonic polyps or colorectal cancer
Evaluation of the extent of involvement of known Crohn disease or ulcerative colitis
Evaluation of the esophagus in individuals with gastroesophageal reflux disease (GERD) or other esophageal pathologies, except as noted above
Current history of dysphagia suggestive of esophageal stricture or swallowing disorders
Initial evaluation of other GI diseases not presenting with GI bleeding, including, but not limited to, celiac sprue and small bowel neoplasm
- Note: If results are equivocal for presentations discussed in the above bullet after other previously performed diagnostic testing has been completed, WCE is approvable for follow-up evaluation
Evaluation of other GI diseases and conditions not presenting with GI bleeding, including, but not limited to, irritable bowel syndrome, Lynch syndrome, portal hypertensive enteropathy, and unexplained chronic abdominal pain
Initial evaluation of individuals with acute upper GI bleeding

MAGNETIC CAPSULE ENDOSCOPY

Magnetic capsule endoscopy (e.g., NaviCam™ Stomach Capsule Endoscopy System [AnX Robotica, Inc., Plano, Texas]) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

PATENCY CAPSULE TESTING

The use of the Given™ AGILE Patency System (Given Imaging Ltd., Yokneam, Israel) or similar devices is considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

GASTROINTESTINAL BLOOD DETECTION CAPSULE

EXPERIMENTAL/INVESTIGATIONAL
Ingestible GI blood detection capsule (e.g., PillSense) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, wireless capsule endoscopy (WCE) is covered under the medical benefits of the Company’s products when medical necessity criteria in the medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The NaviCam™ Stomach Capsule Endoscopy System (AnX Robotica, Inc., Plano, Texas) was approved by the FDA on May 22, 2020. The system is intended for visualization of the stomach of adults 22 years and older with a body mass index (BMI) less than 38. The system can be used in clinics and hospitals, including emergency room settings.

The Given® Diagnostic Imaging System and The PillCam™ SB Capsule (Given Imaging Ltd., Yokneam, Israel) were approved by the FDA on August 1, 2001. The system is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel.

On October 29, 2003, the FDA expanded the indications for use of the Given® Diagnostic Imaging System and the PillCam™ SB Capsule as a tool in the detection of abnormalities of the small bowel mucosa to include adults and children 10 years of age and older.

The Given® Diagnostic Imaging System and the PillCam™ ESO Capsule were approved by the FDA on November 24, 2004. The system is intended for visualization of the esophageal mucosa.

The Given® AGILE Patency System (an optional accessory to the Given® Diagnostic System with PillCam™ Capsules) was approved by the FDA on May 8, 2006. The system is intended for verification of adequate patency of the gastrointestinal (GI) tract prior to administration of the PillCam™ video capsule.

On September 14, 2007, the FDA approved the Olympus Capsule Endoscope System, including the Endo Capsule®, as substantially equivalent to predicate devices. It is intended to be used for visualization of the small bowel mucosa.

On September 28, 2009, the FDA expanded the indications for the Given® PillCam® Platform with PillCam® SB Capsules and the Given® AGILE Patency System to include children from 2 years of age and older.

On May 18, 2012, the FDA approved the MicroCam® Capsule Endoscope System as substantially equivalent to predicate devices. It is intended for use to visualize the small bowel mucosa as a tool in the detection of abnormalities of the small bowel in adults.

In 2014, the FDA approved PillCam COLON under the direct de novo classification for devices with low to moderate risk that have no predicate on the market. PillCam COLON is intended to visualize the colon in patients who have had an incomplete colonoscopy due to a technical impossibility and not incomplete evacuation.

In 2022, the FDA approved PillSense. It is intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB).

Description

Wireless capsule endoscopy (WCE) of the small bowel mucosa requires the use of an ingestible, telemetric, gastrointestinal (GI) capsule that is used as an adjunctive tool to visualize the area of the small bowel that is not accessible through standard upper endoscopy and colonoscopy. The capsule is swallowed and propelled through the GI tract by peristalsis. It has a camera on one end that transmits video images via radio telemetry for up to 72 hours. The video images are transmitted to sensors taped to the body and then stored on a portable recorder. The strength of the signal is used to calculate the position of the capsule as it passes through the GI tract. The stored video images are later downloaded from the portable recorder to a computer, from which they may be viewed in real time. The capsule passes naturally from the body with the stool and, because it is disposable, is not recovered.

Because direct imaging of the small bowel mucosa with an endoscope is limited, WCE of the small bowel mucosa fills a small niche in diagnostic endoscopic procedures for individuals in whom a GI bleeding workup has failed to reveal a source of bleeding and/or a diagnosis. In these instances, WCE is used as an alternative test.

There are several WCE systems currently available. The Given® Diagnostic Imaging System with the PillCam™SB Capsule (Given Diagnostic Ltd., Yokneam, Israel) is intended to evaluate the portion of the small bowel that is not accessible by standard upper and lower GI evaluation. The Given™ Agile Patency System is an optional accessory to the PillCam™ video capsule and is intended to verify adequate patency of the GI tract prior to administration of the PillCam™ video capsule in individuals with known or suspected strictures. There is an insufficiency of peer-reviewed literature supporting the use of the Given™ Agile Patency System or similar systems at this time.

Also intended for diagnostic use, the PillCam™ ESO Capsule is designed to view only the esophagus. It is not intended to replace conventional endoscopy. The PillCam™ ESO Capsule is also swallowed, and it travels through the esophagus by peristalsis. Flashing 14 times per second, the camera in the capsule captures images of the inner lining of the esophagus over a 5-minute period. These images are transmitted to sensors attached to the chest wall, and from the sensors they are sent to a data collection device worn by the individual. The entire procedure lasts approximately 20 minutes. The capsule passes naturally from the body with the stool and, because it is disposable, is not recovered.

In contrast to WCE with the PillCam™ ESO Capsule, conventional esophageal endoscopy is routinely performed to evaluate potential abnormalities in the esophagus and allows for adequate visualization in order for the physician to obtain a biopsy, if necessary. The usefulness of WCE as an alternative method of esophageal assessment has yet to be determined by clinical studies that compare its diagnostic performance and accuracy with that of conventional esophageal endoscopy. However, esophageal WCE has been utilized in individuals with a diagnosis of hepatic cirrhosis to identify medium-to-large varices. WCE is an alternative to conventional endoscopy in individuals with cirrhosis who are anticipated to tolerate adequate doses of beta-blockers.

Since 2007, other wireless endoscopy systems have been approved by the US Food and Drug Administration (FDA) via the 510K pathway for use in visualization of the small bowel mucosa. Olympus America (Center Valley, PA) has developed the Olympus Capsule Endoscope System, including the Endo Capsule®, a device that comes with microtechnology, automatic brightness control, and adjustable illumination to maintain optimal imaging. Similarly, the MiroCam® Endoscope system (IntroMedic Co., LTD, North Attleboro, MA) is designed for use in evaluation of the small bowel mucosa and includes a feature called the Suspected GI Bleeding Indicator (SGIB), intended to mark frames of the video suspected of containing blood or having a "red" appearance. Images are sent at three frames per second, stored on the device's receiver, and uploaded for review.

An ingestible wireless endoscopy capsule intended for small bowel or esophageal visualization should not be confused with an ingestible capsule for GI monitoring through portions of the GI tract (the Smart Pill® GI). Distinctly different from the PillCam™SB Capsule or similar devices, the Smart Pill® GI Monitoring System measures the intestinal pH, and senses pressures and temperature changes as it traverses through portions of the GI tract. The SmartPill® does not provide video images. The Smart Pill® GI Monitoring System is proposed as a way to evaluate gastric emptying for a diagnosis of gastroparesis and to evaluate colonic transit times for chronic constipation.

OBSCURE GI BLEEDING

Obscure GI bleeding is bleeding coming from the GI tract that is persistent or recurring despite upper and lower endoscopy and radiologic evaluation of the small bowel where an obvious etiology cannot be found. Often, there is a level of anemia consistent with blood loss. Much of obscure GI bleeding is caused by lesions in the esophagus, stomach, and colon, with a low percentage found in the small intestine. At this time, there are a large number of uncontrolled studies that reviewed the use of WCE in the evaluation of individuals with occult GI bleeding, which are not useful in the development of criteria for the diagnostic use of WCE.

ACUTE UPPER GI BLEEDING

Studies indicate that WCE does provide useful information for many individuals and permits for risk stratification; however, the yield of WCE in localizing the bleeding source was lower than for esophagogastroduodenoscopy, which is the standard initial evaluation for acute upper GI bleeding. For this reason, it is unlikely that WCE can take the place of upper endoscopy for initial evaluation of acute upper GI bleeding. Controlled studies are needed to further assess the impact of WCE on health outcomes compared to standard management.

ULCERATIVE COLITIS

Ulcerative colitis (UC) is an inflammatory disease of the large intestine and is typically diagnosed with colonoscopy and biopsy. WCE has been proposed in known ulcerative colitis as an alternative method for assessing the extent and severity of disease. Data from 100 individuals with suspected or known UC were evaluated by Sung et al. (2012) via use of WCE and colonoscopy done on the same day. Results indicate that the use of WCE does not appear to be an adequate alternative method of assessing disease activity.

SUSPECTED CROHN DISEASE

Crohn disease, an inflammatory disease of the small intestine, is typically confirmed by small bowel imaging studies and ileocolonoscopy. When these studies are negative or equivocal, WCE has been proposed as a method for identifying Crohn disease. At this time, however, there is no single gold standard diagnostic test for Crohn disease. A Crohn diagnosis is based on a variety of findings, making it difficult to determine which tests in particular determine the positive diagnostic traits needed to confirm a Crohn diagnosis, let alone which test can be considered comparable with WCE. There are no validated diagnostic criteria for interpreting WCE for a diagnosis of Crohn disease, offering a possible explanation about the variability of the diagnostic performance of WCE. However, despite these issues, published literature tends to indicate that when compared with other diagnostic modalities, WCE has at least an equivalent or higher yield of positive findings.

In a patient previously diagnosed with Crohn disease, the utility of WCE is not as certain. Radiographic imaging is preferred over WCE because of the capability to detect obstructive strictures and active disease. An analysis of an international consensus statement indicated that some studies found that WCE had a higher percentage of positive findings than alternative tests in individuals with established Crohn disease. However, it is not clear how these findings correlated with either symptoms or the outcome of therapeutic intervention.

SUSPECTED CELIAC DISEASE

Celiac disease, or gluten-sensitive enteropathy, is an immune-mediated condition of the small intestine. Serologic markers of the disease have good sensitivity and specificity; however, the gold standard for diagnosis of celiac disease is obtained through small-bowel biopsy specimens obtained during endoscopy. WCE has been evaluated as an alternative method of diagnosing celiac disease or in assessing the extent of disease to improve management of individuals, but at this time other methods for diagnosis are considered much more reliable. Small bowel biopsy, celiac serologies, and HLA typing remain the standard tests for confirming celiac disease and have a higher sensitivity and specificity for this purpose. However, when the workup for diagnosis of celiac disease produces equivocal results, WCE can sometimes show morphologic changes in the small bowel consistent with celiac disease.

ESOPHAGEAL CONDITIONS

WCE allows for the ability to visualize several types of esophageal conditions, potentially being a substitute for traditional upper endoscopy for several indications. However, interventional procedures and biopsies cannot be performed. Most studies have shown that WCE has inferior diagnostic characteristics compared to traditional upper endoscopy for a variety of esophageal conditions. A meta-analysis of nine studies comparing WCE to traditional endoscopy for detecting esophageal varices calculated a sensitivity of 83% and a specificity of 85%. Another meta-analysis of nine studies comparing WCE to traditional endoscopy for detecting Barrett esophagus showed a sensitivity and specificity of 77% and 86%, respectively, which is not good enough to substitute for endoscopy.

COLON CANCER SCREENING

WCE has been investigated as a method of colon cancer screening; however, nearly all the published studies have evaluated its use in individuals with a clinical indication for colonoscopy rather than a screening population. Based on the low sensitivity for colonic polyps, WCE is unlikely to be an effective screening test for colon cancer unless it is repeated more frequently than colonoscopy. The specificity of the test is not optimal either, meaning that individuals will undergo unnecessary follow-up colonoscopy.

HEREDITARY GI POLYPOSIS SYNDROMES

Any individual with a family history of familial adenomatous polyposis and Peutz-Jeghers syndrome are at genetically high risk for small bowel polyps and tumors. In a study referenced by Mata et al. (2005), the role of WCE in 24 individuals with hereditary GI polyposis syndromes was examined, and the subjects included those with familial adenomatous polyposis (n=20) or Peutz-Jeghers syndrome (n=4). When those results were compared to barium studies using small bowel enteroclysis, WCE confirmed four additional individuals with small bowel polyps, which were subsequently removed with endoscopic polypectomy. Similarly, in a study by Brown et al. (2006), 19 individuals showed a greater number of polyps identified with WCE than with barium follow-through examinations. Urquhart et al. (2014) compared WCE to magnetic resonance enterography (MRE) for the detection of small bowel polyps in individuals (n=20) with Peutz-Jeghers syndrome, an autosomal dominant disorder characterized by extensive GI hamartomatous polyposis. The authors reported that WCE identified more polyps ≥10 mm than MRE (47 vs. 14 polyps, respectively; P=0.02). However, subsequent balloon enteroscopy (n=12) showed poor correlation of findings between techniques with a 100% positive predictive value of finding a polyp on balloon enteroscopy with MRE versus 60% for capsule endoscopy. Although the studies are small, they do demonstrate that WCE can identify additional lesions in persons with disease syndromes at high risk for such lesions.

There is a paucity of evidence on the use of WCE for small bowel screening in Lynch syndrome. These data are insufficient to determine the prevalence and/or natural history of small bowel polyps in individuals with Lynch syndrome. In addition, surveillance of the small bowel is not generally recommended as a routine intervention for individuals with Lynch syndrome. For this reason, it is not possible to determine whether WCE improves outcomes for individuals with Lynch syndrome.

PORTAL HYPERTENSIVE ENTEROPATHY

Portal hypertensive enteropathy, which may lead to GI bleeding, can develop in individuals with liver cirrhosis and portal hypertension. WCE has been considered as a diagnostic tool for portal hypertensive enteropathy. Analysis of WCE registry data of 45 individuals by Jeon et al. (2014) showed that WCE identified angiodysplasia and varices in 55.7% and 38.9% of individuals with portal hypertensive enteropathy (n=18) versus 7.4% and 0% in individuals without portal hypertensive enteropathy (n=27). Available data are not sufficient to determine whether WCE evaluation of cirrhosis in individuals with portal hypertension can lead to management changes that improve health outcomes.

UNEXPLAINED CHRONIC ABDOMINAL PAIN
Wireless capsule endoscopy has been proposed as a diagnostic tool for unexplained chronic abdominal pain. A systematic review of 21 studies (N=1520) by Xue et al. (2015) found a pooled diagnostic yield of 20.9% (95% confidence interval [CI], 15.9%–25.9%), with the most commonly identified findings of inflammatory lesions (78.3%) and tumors (9.0%). While the studies in the review were highly heterogeneous, limitations in interpreting the findings include retrospective study design, varied duration of abdominal pain, and the use of different tests before WCE.

A study by Yang et al. (2014), which was not included in the systematic review, reported a diagnostic yield of 23% of the 243 individuals evaluated with WCE for unexplained chronic abdominal pain. The authors reported most commonly identified findings of Crohn disease (7.8%), enteritis (6.2%), idiopathic intestinal lymphangiectasia (4.5%), uncinariasis (2.1%), and abnormal transit time (2.1%). Although WCE may yield a diagnosis in individuals with unexplained chronic abdominal pain, several limitations remain: the accuracy of the findings are unclear and the chronology of testing and treatment recommended prior to WCE is undefined. Therefore, the current evidence is insufficient to determine whether WCE is necessary to alter a course of treatment for unexplained chronic abdominal pain to improve health outcomes.

USE OF MAGNETIC CAPSULE ENDOSCOPY

The 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 noninvasive, 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 individuals with GI obstruction, stenosis, fistula, or those with dysphagia. Other contraindications include individuals 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.

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 individual 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 individuals 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.

USE OF THE PATENCY CAPSULE

Limited data exist on the performance of the patency capsules proposed as a technique to evaluate individuals with known or suspected strictures prior to using the wireless WCE system. The published studies are small and do not provide comparative data about the incremental value of this capsule over standard clinical evaluation. Sometimes the use of the patency capsule produced symptoms that caused the individual to be hospitalized and some persons required surgery to retrieve the capsule. There are also direct contraindications for the use of the patency capsule, including known obstruction, stricture, and diverticulum and intestinal motility problems.

In sum, WCE is a procedure that allows for visualization of intestinal mucosa that is not accessible by traditional upper or lower endoscopy. It has been most extensively studied in individuals with obscure GI bleeding. For this population, the evidence demonstrates that WCE can identify a bleeding source in a substantial number of individuals in whom a diagnosis is not possible by other methods, with a low incidence of adverse events. Because there are no other options for diagnosing obscure small bowel bleeding in individuals who have negative upper and lower endoscopy, this technique will likely improve health outcomes by directing specific treatment when a bleeding source is identified.

Similarly, for individuals with suspected small bowel Crohn disease and for individuals with familial polyposis syndromes who require surveillance of the small bowel, other methods are not available for visualizing the small bowel. Although the performance characteristics of the capsule for these indications are uncertain, it is likely to improve health outcomes by identifying some cases of these disorders and directing specific treatment.

For other conditions, including acute upper GI bleeding, determining the extent of involvement in Crohn disease, ulcerative colitis, celiac disease, esophageal conditions, Lynch syndrome, colon cancer screening, and for determination of patency of the GI tract, the evidence is not sufficient to conclude that health outcomes are improved. For persons with esophageal conditions or the need for colon cancer screening, other modalities are available that are superior to WCE. In determining the extent of Crohn disease, the accuracy of the device must be determined before it can be established that health outcomes are improved.

For individuals with established Crohn disease, small bowel WCE is better at identifying small-bowel mucosal lesions than barium and may be better than CT or MR enterography or enteroclysis, but the clinical significance of this potential difference remains to be defined. There are no validated diagnostic criteria for small bowel WCE for the diagnosis of Crohn disease.

The use of WCE for colorectal cancer screening and diagnosis is not recommended in published European guidelines in 2010. These guidelines discuss the superiority of the diagnostic performance of colonoscopy to WCE in the studies reported in these guidelines.

GASTROINTESTINAL BLOOD DETECTION CAPSULE

In September 2022, the FDA approved an ingestible GI blood detection capsule (e.g., PillSense). The system consists of a PillSense capsule and PillSense receiver. The capsule and receiver components are packaged and sold separately or as a system. The capsule is a single-patient use, battery-powered capsule that features sensors that detect blood and wirelessly transmit data to an external receiver. The capsule makes its way through the GI tract and is then passed naturally from the body. The reusable receiver collects and displays real-time information gathered by the capsule. The receiver interprets the data and displays a sensor output value. These values are plotted on a chart using data acquisition and when completed displays a "blood detected" or "no blood detected" message. The software supports entering of patient information, pairing of the receiver and capsule, and data interpretation and display. The device is contraindicated for patients with known GI obstructions or strictures. GI blood detection capsule (PillSense) is not a standalone diagnostic device, but an adjunct for clinical decision making. A negative or normal result obtained by the PillSense system does not exclude presence of pathology; if symptoms persist, further evaluation should be performed.

Although the FDA has approved devices for PillSense gastrointestinal blood detection capsule, the Company has determined that the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. Therefore, PillSense is considered experimental/investigational by the Company and not covered.

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Eliakim R, Sharma VK, Yassin K, et al. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005:39(7):572-578.

Eliakim R, Yassin K, Shlomi I, et al. A novel diagnostic tool for detecting oesophageal pathology: the Pillcam oesophageal video capsule. Aliment Pharmacol Ther. 2004;20(10):1083-1089.

El-Matary W, Huynh H, Vandermeer B. Diagnostic characteristics of given video capsule endoscopy in diagnosis of celiac disease: a meta-analysis. J Laparoendosc Adv Surg Tech A. 2009;19(6):815-820.

Ell C, Remke S, May A, et al. The first prospective controlled trial comparing wireless capsule endoscopy with push enteroscopy in chronic gastrointestinal bleeding. Endoscopy. 2002;34(9):685-689.

Elosua A, Rullan M, Rubio S, et al. Does capsule endoscopy impact clinical management in established Crohn's disease? Dig Liver Dis. 2022;54(1):118-124.

Enns R. Clinical Practice Guidelines for the Use of Video Capsule Endoscopy. Gastroenterology. 2017;152:497-514.

Fireman Z, Mahajna E, Broide E, et al. Diagnosing small bowel Crohn’s disease with wireless capsule endoscopy. Gut. 2003;52(3):390-392.

Galmiche JP, Sacher-Huvelin S, Coron E, et al. Screening for esophagitis and Barrett's esophagus with wireless esophageal capsule endoscopy: a multicenter prospective trial in patients with reflux symptoms. Am J Gastroenterol. 2008;103(3):538-545.

Gerson LB, Fidler JL, Cave DR, et al. ACG Clinical Guideline: diagnosis and management of small bowel bleeding. Am J Gastroenterol. 2015;110(9):1265-1287; quiz 1288.

Gilani N, Stipho S, Shaukat MS, et al. The yield and safety of string capsule endoscopy in patients with dysphagia. Gastrointest Endosc. 2007;66(6):1091-1095.

Gong F, Swain P, Mills T. Wireless endoscopy. Gastrointest Endosc. 2000;51(6):725-729.

Gostout CJ. Capsule Endoscopy. Clinical Update, American Society for Gastrointestinal Endoscopy; Vol. 10. No. 2 October 2002.

Gralnek IM, Ching JY, Maza I, et al. Capsule endoscopy in acute upper gastrointestinal hemorrhage: a prospective cohort study. Endoscopy. 2013;45(1):12-199.

Gutkin E, Shalomov A, Hussain SA, et al. Pillcam ESO® is more accurate than clinical scoring systems in risk stratifying emergency room patients with acute upper gastrointestinal bleeding. Therap Adv Gastroenterol. 2013;6(3):193-198.

Guturu P, Sagi SV, Ahn D, et al. Capsule endoscopy with PILLCAM ESO for detecting esophageal varices: a meta-analysis. Minerva Gastroenterol Dietol. 2011;57(1):1-11.

Hahne M, Adamek HE, Schilling D, Riemann JF. Wireless capsule endoscopy in a patient with obscure occult bleeding. Endoscopy. 2002;34(7):588-590.

Haanstra JF, Al-Toma A, Dekker E, et al. Prevalence of small-bowel neoplasia in Lynch syndrome assessed by video capsule endoscopy. Gut. 2015;64(10):1578-1583.

Hartmann D, Schmidt H, Bolz G, et al. A prospective two-center study comparing wireless capsule endoscopy with intraoperative enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2005;61(7):826-832.

Herrerías JM, Caunedo A, Rodríguez-Telléz M, Pellicer F, Herrerías JM Jr. Capsule endoscopy in patients with suspected Crohn's disease and negative endoscopy. Endoscopy. 2003;35(7):564-568.

Herrerias JM, Leighton JA, Costamagna G, et al. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008;67(6):902-909.

Jeon SR, Kim JO, Kim JB, et al. Portal hypertensive enteropathy diagnosed by capsule endoscopy in cirrhotic patients: a nationwide multicenter study. Dig Dis Sci. 2014;59(5):1036-1041.

Kalantzis N, Papanikolaou IS, Giannakoulopoulou E, et al. Capsule endoscopy; the cumulative experience from its use in 193 patients with suspected small bowel disease. Hepatogastroenterology. 2005;52(62):414-419.

Kjolhede T, Olholm AM, Kaalby L, et al. Diagnostic accuracy of capsule endoscopy compared with colonoscopy for polyp detection: systematic review and meta-analyses. Endoscopy. 2021; 53(7): 713-721.

Koornstra JJ. Small bowel endoscopy in familial adenomatous polyposis and Lynch syndrome. Best Pract Res Clin Gastroenterol. 2012;26(3):359-368.

Kopylov U, Yung DE, Engel T, et al. Diagnostic yield of capsule endoscopy versus magnetic resonance enterography and small bowel contrast ultrasound in the evaluation of small bowel Crohn's disease: Systematic review and meta-analysis. Dig Liver Dis. 2017;49(8):854-863.

Koulaouzidis A, Rondonotti E, Giannakou A, et al. Diagnostic yield of small-bowel capsule endoscopy in patients with iron-deficiency anemia: a systematic review. Gastrointest Endosc. 2012;76(5):983-992.

Kurien M, Evans KE, Aziz I, et al. Capsule endoscopy in adult celiac disease: a potential role in equivocal cases of celiac disease? Gastrointest Endosc. 2013;77(2):227-232.

Lansdorp-Vogelaar I, von Karsa L; International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Introduction. Endoscopy. 2012;44(Suppl3):SE15-30.

Leung WK, Ho SS, Suen BY, et al. Capsule endoscopy or angiography in patients with acute overt obscure gastrointestinal bleeding: a prospective randomized study with long-term follow-up. Am J Gastroenterol. 2012;107(9):1370-1376.

Lewis BS. Small intestinal bleeding. Gastroenterol Clin North Am. 2000;29(1):67-95.

Lewis BS, Swain P. Capsule endoscopy in the evaluation of patients with suspected small intestinal bleeding: results of a pilot study. Gastrointest Endosc. 2002;56(3):349-53.

Liao Z, Hou X, Lin-Hu EQ, et al. Accuracy of magnetically controlled capsule endoscopy, compared with conventional gastroscopy, in detection of gastric diseases. Clin Gastroenterol Hepatol. 2016;14(9):1266-1273.e1.

Lichtenstein GR, Loftus EV, Isaacs KL et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4).

Lima Capela T, Cúrdia Gonçalves T, Rosa B, Cotter J. Best Approach for Incomplete Colonoscopy: Colon Capsule Endoscopy or Repeat Conventional Colonoscopy?. GE Port J Gastroenterol. 2024;32(5):320-328.

Lin OS, Schembre DB, Mergener K, et al. Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux. Gastrointest Endos. 2007;65(4):577-583.

Marijnissen FE, Moen S, van Enckevort CCG, et al. Applicability of colon capsule endoscopy in FIT-positive individuals unable or unwilling to undergo colonoscopy within a colorectal cancer screening programme: a prospective multicentre study. Ther Adv Gastrointest Endosc. 2026;19:26317745251415118.

Marmo R, Rotondano G, Piscopo R, et al. Capsule endoscopy versus enteroclysis in the detection of small-bowel involvement in Crohn’s disease: a prospective trial. Clin Gastroenterol Hepatol. 2005;3(8):772-776.

Mata A, Llach J, Castells A, et al. A prospective trial comparing wireless capsule endoscopy and barium contrast series for small-bowel surveillance in hereditary GI polyposis syndromes. Gastrointest Endosc. 2005;61(6):721-725.

Mishkin DS, Chuttani R, Croffie J, et al. ASGE Technology Status Evaluation Report: Wireless Capsule Endoscopy. Gastrointest Endosc. 2006;63(4):539-545.

Novitas Solutions, Inc. Local Coverage Determination (LCD).L35089: Billing and Coding: Wireless Capsule Endoscopy. [Novitas Solutions, Inc. Web site]. 11/21/2019. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35089&ver=30&Keyword=wireless+capsule&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=BC|SAD|RTC|Reg&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA&. Accessed February 16, 2026.

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Oliva S, Di Nardo G, Hassan C, et al. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study. Endoscopy. 2014;46(6):485-492.

Pennazio M, Santucci R, Rondonotti E, et al. Outcome of patients with obscure gastrointestinal bleeding after capsule endoscopy; report of 100 consecutive cases. Gastroenterology. 2004;126(3):643-653.

Perez-Cuadrado-Robles E. The role of capsule endoscopy in alarm features and non-responsive celiac disease: a European multi-centre study. Dig Endosc. 2018;30(4):461-466.

Pilz JB, Portmann S, Peter S, et al. Colon capsule endoscopy compared to conventional colonoscopy under routine screening conditions. BMC Gastroenterol. 2010;10:66.

Postgate AJ, Burling D, Gupta A, et al. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008;53(10):2732-2738.

Raju GS, Gerson L, Das A, et al. American Gastroenterological Association (AGA) Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology. 2007;133(5):1694-1696.

Raju GS, Gerson L, Das A, et al. American Gastroenterological Association (AGA) Institute technical review on obscure gastrointestinal bleeding. Gastroenterology. 2007;133(5):1697-1717.

Ramirez FC, Akins R, Shaukat M. Screening of Barrett's esophagus with string-capsule endoscopy: a prospective blinded study of 100 consecutive patients using histology as the criterion standard. Gastrointest Endosc. 2008;8(1):25-31.

Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015;148(5):948-957.

Rokkas T, Niv Y. The role of video capsule endoscopy in the diagnosis of celiac disease: a meta-analysis. Eur J Gastroenterol Hepatol. 2012;24(3):303-308.

San Juan-Acosta M, Caunedo-Alvarez A, Arguelles-Arias F, et al. Colon capsule endoscopy is a safe and useful tool to assess disease parameters in patients with ulcerative colitis. Eur J Gastroenterol Hepatol. 2014;26(8):894-901.

Schoofs N, Devière J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study. Endoscopy. 2006;38(10):971-977.

Sihag S, O'Hara F, McNamara D. Toward an expanded role for video capsule endoscopy in patients with gastrointestinal bleeding: A review of the literature. World J Gastrointest Endosc. 2025;17(11):108788.

Spada C, Hassan C, Marmo R, et al. Meta-analysis shows colon capsule endoscopy is effective in detecting colorectal polyps. Clin Gastroenterol Hepatol. 2010;8(6):516-522.

Spada C, Shah SK, Riccioni ME, et al. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007;41(6):576-582.

Sung J, Ho KY, Chiu HM, et al. The use of Pillcam Colon in assessing mucosal inflammation in ulcerative colitis: a multicenter study. Endoscopy. 2012;44(8):754-758.

Urquhart P, Grimpen F, Lim GJ, et al. Capsule endoscopy versus magnetic resonance enterography for the detection of small bowel polyps in Peutz-Jeghers syndrome. Fam Cancer. 2014;13(2):249-255.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

91110, 91111

EXPERIMENTAL/INVESTIGATIONAL

0651T, 0977T, 91113

THE FOLLOWING CODE REPRESENTS THE GIVEN AGILE PATENCY SYSTEM OR SIMILAR DEVICES

91299

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment A.

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.05.02t:

04/01/2026	This policy has been reviewed and reissued to communicate the Company’s continuing position on wireless capsule endoscopy for gastrointestinal (GI) disorders.
10/20/2025	This version of the policy will become effective 10/20/2025. The policy was updated to include the continuation of noncovered gastrointestinal blood detection capsule as experimental/investigational. The following CPT code has been added to the policy as Experimental/Investigational: 0977T.

Revisions From 07.05.02s:

10/01/2024

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the ICD-10 code update, effective 10/01/2024.

The following ICD-10 code has been added to Attachment A of this policy:

Z83.72 Family history of familial adenomatous polyposis

Revisions From 07.05.02r:

02/07/2024	This policy has been reissued in accordance with the Company's annual review process.
10/01/2023	Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. This policy has been identified for the ICD-10 code update, effective 10/01/2023. The following ICD-10 code narrative has been revised: FROM: Q85.81 PTEN tumor syndrome TO: Q85.81 PTEN hamartoma tumor syndrome

02/07/2024

This policy has been reissued in accordance with the Company's annual review process.

10/01/2023

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the ICD-10 code update, effective 10/01/2023.

The following ICD-10 code narrative has been revised:

FROM: Q85.81 PTEN tumor syndrome

TO: Q85.81 PTEN hamartoma tumor syndrome

Revisions From 07.05.02q:

05/17/2023	The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders.
01/01/2023	This version of the policy will become effective 01/01/2023. The title of the policy has changed to Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders. The policy was updated to include a statement for Magnetic Capsule Endoscopy as Experimental/Investigational. The following CPT codes has been added to the policy as Experimental/Investigational: 0651T

Revisions From 07.05.02p:

10/01/2022

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the ICD-10 code update, effective 10/01/2022.

The following ICD-10 code has been termed and removed from the policy:

Q85.8 Other phakomatoses, not elsewhere classified

The following ICD-10 code has been added to Attachment A of this policy:

Q85.81 PTEN tumor syndrome

Q85.82 Other Cowden syndrome

Q85.89 Other phakomatoses, not elsewhere classified

Revisions From 07.05.02o:

01/01/2022

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the CPT code update, effective 01/01/2022.

The following CPT code has been added to the policy as Experimental/Investigational: 91113.

The following CPT code has been termed from the policy: 0355T.

The following CPT narrative has been revised in this policy: 91110.

Revisions From 07.05.02n:

06/16/2021	The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon.
02/12/2020	The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon.
01/31/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

10/20/2025

Version Issued Date:

10/20/2025

Version Reissued Date:

4/1/2026