Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon

Policy #:07.05.02n

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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 U.S. 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's 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'S DISEASE
  • For initial diagnosis in individuals with suspected, but unconfirmed, Crohn's disease or for Crohn's 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's 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 non-diagnostic 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 where an indeterminate type of colitis exists, but where 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's 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 gastrointestinal 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 gastrointestinal 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

PATENCY CAPSULE TESTING

The use of the Given AGILE Patency System (Given Imaging Ltd., Yoqneam, 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.

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 Given® Diagnostic Imaging System and The PillCam SB Capsule (Given Imaging Ltd., Yoqneam, Israel) were approved by the US Food and Drug Administration (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 two 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.

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, since it is disposable, is not recovered.

Since 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., Yoqneam, Israel) is intended to evaluate the portion of the small bowel that is not accessible by standard upper and lower gastrointestinal 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 five-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, since 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-large varices. WCE is an alternative to conventional endoscopy in cirrhotic individuals 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 micro technology, 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 musoca 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 gastrointestinal (GI) monitoring through portions of the GI tract (the Smart Pill® GI). Distinctly different from the PillCamSB 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 gastrointestinal 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 gastrointestinal (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 due to 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 one hundred individuals with suspected or known UC were evaluated by Sung et al 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'S DISEASE

Crohn’s disease is an inflammatory disease of the small intestine and 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’s disease. At this time, however, there is no single gold standard diagnostic test for Crohn’s disease. A Crohn's 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's 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’s 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's 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’s 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 biopsies 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’s 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, 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., 19 individuals showed a greater number of polyps identified with WCE than with barium follow-through examinations Urquhart et al 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 WCE identified more polyps >10mm 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. While 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. This data is 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. showed 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 is 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 found a pooled diagnostic yield of 20.9% (95% 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, 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's disease (7.8%), enteritis (6.2%), idiopathic intestinal lymphangiectasia (4.5%), uncinariasis (2.1%), abnormal transit time (2.1%). While 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 THE PATENCY CAPSULE

Limited data exists 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 who are unable to be diagnosed by other methods, with a low incidence of adverse events. Since 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’s 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’s 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's disease, the accuracy of the device must be determined before it can be established that health outcomes are improved.

For individuals with established Crohn’s 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’s 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.
References


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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):227-32.

Lansdorp-Vogelaar I, von Karsa L; International Agency for Research on C. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Introduction. Endoscopy. 2012;44Suppl3: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):1370-6.

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.

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.

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):772-76.

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):721-5.

Mishkin, DS, et al. ASGE Technology Status Evaluation Report: Wireless Capsule Endoscopy. Gastrointest Endosc. 2006;63(4):539-45.

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):643-53.

Perez-Cuadrado-Robles E. The role of capsule endoscopy in alarm features and non-responsive celiac disease: a European multi-centre study. Dig Endosc.2017 Dec 18. [Epub ahead of print].

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):2732-8.

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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.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
91110, 91111

EXPERIMENTAL/INVESTIGATIONAL
0355T

THE FOLLOWING CODE REPRESENTS THE GIVEN AGILE PATENCY SYSTEM OR SIMILAR DEVICES:
91299


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Wireless Capsule Endoscopy (WCE) as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon
Description: ICD-10-CM Codes




Policy History

Revisions from 07.05.02n:
01/31/2018The 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: 12/16/2016
Version Issued Date: 12/16/2016
Version Reissued Date: 01/31/2018

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