Colon Capsule Endoscopy (CCE)

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR 410.32 indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of their license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter

CMS Publications:

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 23: 10.1 - 10.1.7 ICD-10-CM Coding for Diagnostic Tests.

Diagnostic and/or surveillance* (performed for signs/symptoms of disease) colon capsule colonoscopy (CCE) is medically necessary for the detection of colon polyps when EITHER of the following criteria are met:

1. Secondary procedure after an incomplete diagnostic optical colonoscopy (OC) with adequate preparation, and a complete evaluation of the colon was not technically possible (1,2) when EITHER of the following criteria are met
1. Detection or surveillance of colon polyp(s) OR
2. Diagnostic procedure when ANY of the following criteria are met (3):
1. Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR
2. Multitarget Stool DNA (sDNA) Test positive OR
3. Other evidence of lower GI bleed in hemodynamically stable patients
2. Primary procedure in patients with major risks for OC or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training when EITHER of the following criteria are met:
1. Surveillance of colon polyp(s) in previously diagnosed patients OR
2. Diagnostic procedure when ANY of the following criteria are met (3):
1. Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR
2. Multitarget Stool DNA (sDNA) Test positive OR
3. Other evidence of lower GI bleed in hemodynamically stable patients

Exclusion Criteria (NONE of the below are allowed)

1. Known or suspected gastrointestinal obstruction, stricture, or fistula
2. Cardiac pacemaker or another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency or other interfering signal
3. Swallowing disorder
4. Known contraindication or allergy to any medication or preparation agent used before or during the procedure
5. May not be done in conjunction with CT Colonography (CTC)
6. CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease

* Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such.

CCE is a noninvasive procedure that does not require air inflation or sedation and allows for minimally invasive and painless colonic evaluation. CCE utilizes a tiny wireless camera that takes pictures of the gastrointestinal tract. The wireless camera is housed inside a vitamin-size capsule that is swallowed with water. As the capsule travels through the digestive tract, the camera takes pictures that are transmitted to a recorder worn by the patient. The images are then transmitted to a computer with special software where the images are strung together to create a video. The provider reviews the video to look for any abnormalities within the gastrointestinal tract.

The first-generation device had a low sensitivity and specificity for polyps in the colon, however a second-generation device received FDA clearance January 2014 and expanded use in January 2016 (1,2). The improved design is slightly bigger with two cameras and increased angle of view allowing nearly 360-degree coverage of the colon. The capsule battery last 10 hours with a slower frame rate. Improvements in software allow estimation of polyp size and improved mucosal surface evaluation. Unless indicated, reference to CCE is specific to the second-generation device. Both FDA indications are specific to colon polyp detection, but whereas the original restricted to use as a secondary procedure after failed OC, the expanded indication included use as a primary procedure in patients at major risk for colonoscopy or moderate sedation, and with evidence of lower GI bleeding. See Table 1 for details of the following studies.

The pivotal trial that led to FDA clearance was a prospective blinded study of 884 asymptomatic patients classified as average colorectal cancer (CRC) risk (4). Technical failures (short transit time plus poor preparation) occurred in 9% of patients. The authors conclude based on polyp detection sensitivity and specificity data that: “capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies.”

Two studies comparing CCE to CTC demonstrated at least non-inferiority in terms of sensitivity and specificity (5,6). One found improved sensitivity and specificity for CCE, but both studies had methodological flaws with low quality evidence. Advantages to CTC include the ability to use when obstruction or stricture is a concern and to obtain visualization of other abdominal structures. Advantages to CCE are the lack of radiation exposure and direct visualization of colorectal mucosa. Patient preference and availability of the technology also may play a role in test selection.

Several studies have shown that CCE sensitivity and specificity remain high in detection of polyps in positive fecal occult blood test (FOBT) patients (5,7,8). FOBT sensitivity for small adenomas is reported to be 7% so the majority in these cases will not need referral to OC if the CEE is adequate and negative (9). The authors generally conclude that in patients at high risk for OC, or who have incomplete OC, CCE may be reasonable alternative. Several studies included FOBT positive patients, among other indications (e.g., melena), but did not stratify results (10-12).

Table 1 Clinical Literature

Multiple international papers reported similar findings for sensitivity and specificity (13-16). Completion rate was found to be lower than optical colonoscopy (OC) and incomplete studies (range from 0-46%) were more likely to miss malignancies (8). CCE performance was less accurate than OC confirming that it remains the preferred testing modality.

A 2015 Health Quality Ontario meta-analysis on colon capsule endoscopy for the detection of colorectal polyps included five studies which evaluated CCE with a pooled total of 357 subjects (17). It found a 87% sensitivity and 76% specificity for 6 mm polyps, and 89% sensitivity and 91% specificity for 10 mm polyps, which was described as good sensitivity and specificity. The analysis did not include papers published after 2014. See Table 2 for details.

A 2016 meta-analysis with 2,420 subjects reported the following: for polyps > 6 mm: 86% (82%-89%) sensitivity and 88% (74%-95%) specificity. For polyps > 10 mm: 87% (81%-91%) sensitivity and 95% (92%-98%) specificity (18). The consistency in the findings among the studies over an eight year period, and improved sample size and design in the more recent studies, improve the overall quality of the data from the earlier assessments. Limitations of the technology include poor sensitivity for sessile polyps and high rate of incomplete studies. See Table 2 for details.

Table 2 Systematic Reviews

These systematic review results, combined with the consistent positive safety profile, has led several organizations to consider the CCE a suitable alternative to CTC for incomplete colonoscopy. The European Society of Gastrointestinal Endoscopy (ESGE) considers CCE a reasonable alternative to screening colonoscopy in low cancer risk patients. The Canadian Clinical Practice Guidelines for the Use of Video Capsule endoscopy consensus statement recommends against the routine substitution of CCE for colonoscopy (GRADE: Strong recommendation, low quality evidence), however “In cases in which previous colonoscopy was incomplete or for patient who are unwilling/unable to undergo colonoscopy, CCE has shown to be a reasonable alternative (19).

A 2018 ECRI Technology assessment rates evidence as “somewhat favorable” and concludes: “Evidence from two systematic reviews indicates CCE can detect polyps in patients unable or unwilling to undergo colonoscopy or who had an incomplete colonoscopy” (20). Studies also indicate CCE related adverse events (AEs) are rare. The ECRI report also reviewed FDA MAUDE reports, which was consistent with literature in terms of adverse events and safety profile; the most common complication is capsule retention.

A 2019 Hayes technology assessment assigns CCE a “C” rating for use in diagnosis and surveillance of adults with signs or symptoms of colorectal cancer and risk factors for the disease (21). It concludes: “CCE may be a suitable alternative for patients who cannot tolerate or refuse to undergo conventional colonoscopy (CC) and for patients with an incomplete CC.” The rating was downgraded due to paucity of evidence regarding clinical utility of CCE for this indication. The report calls for further studies to determine the accuracy of CCE verses CTC.

The American Society for Gastrointestinal Endoscopy (ASGE) US Multi-Society Task Force (MSTF) on CRC recommends CCE as “an appropriate screening test when patients decline colonoscopy, FIT, FIT-fecal DNA, CTC, and flexible sigmoidoscopy” (weak recommendation, low quality evidence) (22).

In summary, the evidence supports the recommendation that CCE may be a suitable alternative to OC or CTC in a very select group of patients for whom a diagnostic OC for suspected polyps was either unsuccessful or relatively contraindicated. Ideally, CCE is performed after incomplete colonoscopy (if adequate preparation) to avoid the need for repeat bowel preparation (23).

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