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Wireless Capsule Endoscopy (Given® Video Capsule)

Policy Number: MP-017

Latest Review Date: December 2020

Category:  Radiology                                                             

Policy Grade:  B

DRAFT

POLICY:

Effective for dates of service on and after December 16, 2020:

Wireless Capsule Endoscopy/Given® Imaging System including the disposable Pillcam SB capsule and interpretation of the data by the Given® data recorder may be considered medically necessary for the following indications:

  1. Suspected small bowel bleeding as evidenced by the following:
  • Must be experiencing gastrointestinal blood loss and anemia secondary to bleeding.
  • Must have a negative diagnostic work-up (e.g., upper GI, EGD, or colonoscopy). A negative diagnostic work up is defined as one which did not identify the source or condition which caused the blood loss. Positive findings which could not attribute to the blood loss would still constitute a negative diagnostic work up since the cause of blood loss was not identified (i.e. inconclusive).
  1. In the initial diagnosis in patients with suspected Crohn’s disease without evidence of disease on conventional diagnostic tests such as but not limited to:
    1. Upper GI,
    2. EGD,
    3. Small Bowel Follow Through, or
    4. Colonoscopy
  2. In patients with an established diagnosis of Crohn 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.
  3. For surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.

Wireless Capsule Endoscopy/Given® Imaging System including the disposable PillCam SB capsule and interpretation of the data by the Given® data recorder is considered not medically necessary and investigational for other than above 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 patients with gastroesophageal reflux (GERD) or other esophageal pathologies
  • Abdominal pain in the absence of gastrointestinal bleeding
  • Confirmation of lesion/pathology found by other diagnostic means
  • As initial procedure in the diagnosis of gastrointestinal bleeding where upper or lower endoscopies have not been performed
  • Evaluation of other gastrointestinal 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 patients with acute upper GI bleeding.
  • Evaluation of patients with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation.
  • Evaluation of patients following incomplete colonoscopy.

The Given® AGILE Patency System including the patency capsule and the patency scanner, used to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy, is considered not medically necessary and investigational.

Effective for dates of service prior to December 15, 2020:

Wireless Capsule Endoscopy/Given® Imaging System including the disposable Pillcam SB capsule and interpretation of the data by the Given® data recorder may be considered medically necessary for the following indications:

      1. Suspected small bowel bleeding as evidenced by the following:

  • Must be experiencing gastrointestinal blood loss and anemia secondary to bleeding.
  • Must have a negative diagnostic work-up (e.g., upper GI, EGD, or colonoscopy). A negative diagnostic work up is defined as one which did not identify the source or condition which caused the blood loss. Positive findings which could not attribute to the blood loss would still constitute a negative diagnostic work up since the cause of blood loss was not identified (i.e. inconclusive).

     2. In the initial diagnosis in patients with suspected Crohn’s disease without evidence of disease on conventional diagnostic tests such as but not limited to:

  1. Upper GI,
  2. EGD,
  3. Small Bowel Follow Through, or
  4. Colonoscopy

     3. In patients with an established diagnosis of Crohn 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.

     4. For surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome.

Wireless Capsule Endoscopy/Given® Imaging System including the disposable PillCam SB capsule and interpretation of the data by the Given® data recorder is considered not medically necessary and investigational for other than above 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 patients with gastroesophageal reflux (GERD) or other esophageal pathologies
  • Abdominal pain in the absence of gastrointestinal bleeding
  • Confirmation of lesion/pathology found by other diagnostic means
  • As initial procedure in the diagnosis of gastrointestinal bleeding where upper or lower endoscopies have not been performed
  • Evaluation of other gastrointestinal 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 patients with acute upper GI bleeding.

The Given® AGILE Patency System including the patency capsule and the patency scanner, used to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy, is considered not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

The wireless capsule endoscopy (CE) uses a device to visualize segments of the gastrointesinal tract. Patients swallow a capsule that records images of the intestinal mucosa as it passes through the gastrointestinal (GI) tract. The capsule is collected after being excreted and images interpreted.

Wireless Capsule Endoscopy

Wireless CE 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 two 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 localizing antennae sensors that can roughly gage where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.

CE 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.

KEY POINTS:

The most recent literature review was updated through September 21, 2020.

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 nondiagnostic standard workup. The 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 a meaningful improvement in the net health outcome.

For individuals who have suspected small bowel CD who receive wireless CE, the evidence includes case series. The 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 these indications 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 a meaningful 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. The relevant outcomes are test 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 (eg, determining the extent of CD), direct evidence of improved outcomes or a strong indirect chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine the effects of technology on net health outcomes.

For individuals who have unexplained chronic abdominal pain who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. The 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 the effects of technology on net health outcomes.

Patients With Confirmed GI Disorders

For individuals who have an established diagnosis of CD who receive wireless CE, the evidence includes diagnostic accuracy studies and a systematic review. The 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 compared 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. The evidence is sufficient to determine that the technology results in a meaningful 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. The 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 or a strong chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine the effects of technology on net health outcomes.

For individuals who have esophageal disorders who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. The 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 the effects of technology on net health outcomes.

For individuals who have hereditary GI polyposis syndromes who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. The 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 the effects of technology on net health outcomes.

For individuals who have portal hypertensive enteropathy who receive wireless CE, the evidence includes case series and diagnostic accuracy studies. The relevant outcomes are test validity, and other test performance measures, symptoms, and change in disease status. Systematic reviews of studies of its diagnostic performance for this purpose 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 the effects of technology on net health outcomes.

Acute Upper GI Bleeding

For individuals who have acute upper GI tract bleeding who receive wireless CE, the evidence includes an RCT and several cohort studies. The relevant outcomes are test validity, and other test performance measures, symptoms, change in disease status, 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 the effects of technology on net health outcomes.

Colon Cancer Screening

For individuals who are screened for colon cancer who receive wireless CE, the evidence includes diagnostic accuracy studies and systematic reviews. The 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 potentially. 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 the effects of technology on net health outcomes.

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 overall survival, disease-specific survival, resource utilization, test validity, and other test performance measures. 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 the effects of the technology on 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 overall survival, disease-specific survival, resource utilization, test validity, and other test performance measures. 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 the effects of the technology on net health outcomes.

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. The 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 the effects of technology on net health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American College of Gastroenterology

The ACG (2013) issued guidelines on the diagnosis and management of celiac disease. The guidelines recommended that capsule endoscopy (CE) not be used for initial diagnosis, except for patients with positive celiac-specific serology who are unwilling or unable to undergo upper endoscopy with biopsy (strong recommendation, moderate level of evidence).

CE should be considered for the evaluation of small bowel mucosa in patients with complicated Crohn disease (CD; strong recommendation, moderate level of evidence). 

The ACG (2018) updated its guidelines on the management of CD in adults. It makes two2 recommendations specific to video capsule endoscopy:

“Video capsule endoscopy (VCE) is a useful adjunct in the diagnosis of patients with small bowel Crohn’s disease in patients in whom there is a high index of suspicion of disease.”

“Patients with obstructive symptoms should have small bowel imaging and/or patency capsule evaluation before VCE to decrease risk of capsule retention.”

These recommendations are based on multiple studies. Capsule endoscopy was found to be “superior to small bowel barium studies, computed tomography enterography (CTE) and ileocolonoscopy in patients with suspected CD, with incremental yield of diagnosis of 32%, 47%, and 22%, respectively….Capsule endoscopy has a high negative predictive value of 96%.”

“However, some studies have questioned the specificity of capsule endoscopy findings for CD, and to date there is no consensus as to exactly which capsule endoscopy findings constitute a diagnosis of CD.”

The ACG (2015) issued guidelines on the diagnosis and management of small bowel bleeding (including using “small bowel bleeding” to replace “obscure GI [gastrointestinal] bleeding,” which should be reserved for patients in whom a source of bleeding cannot be identified anywhere in the GI tract). These guidelines made the following statements related to video CE (see Table 15).

Table 15. Recommendations on Diagnosis and Management of Small Bowel Bleeding

Recommendation

SOR

LOE

“… VCE should be considered as a first-line procedure for SB evaluation after upper and lower GI sources have been excluded, including second-look endoscopy when indicated”

Strong

Moderate

“VCE should be performed before deep enteroscopy to increase diagnostic yield. Initial deep enteroscopy can be considered in cases of massive hemorrhage or when VCE is contraindicated”

Strong

High

GI: gastrointestinal; LOE: level of evidence; SB: small bowel; SOR: strength of recommendation; VCE: video capsule endoscopy.

American Society of Gastrointestinal Endoscopy

The American Society of Gastrointestinal Endoscopy (2016) published guidelines for the use of endoscopy in the management of suspected small bowel bleeding. These guidelines made the following recommendations on capsule endoscopy (VCE) (see Table 16).

Table 16. Recommendations on Use of Endoscopy to Manage Suspected Small Bowel Bleeding

Recommendation

QOE

We suggest VCE as the initial test for patients with overt or occult small-bowel bleeding. Positive VCE results should be followed with push enteroscopy if within reach or DAE.”

Moderate

“We suggest DAE or push enteroscopy if VCE is unavailable or nondiagnostic in patients with overt small bowel bleeding.”

Moderate

DAE: device-assisted enteroscopy; QOE: quality of evidence; VCE: video capsule endoscopy.

American Gastroenterological Association Institute

The American Gastroenterological Institute (AGA)(2017) issued guidelines on the use of capsule endoscopy. Table 17. summarizes the most relevant recommendations (not all recommendations are included).

Table 17. AGA 2017 Capsule Endoscopy Recommendations

Stmt No.     

Recommendation

Grade

QOE

 

Recommendations Supporting the Use of Capsule Endoscopy (CE)

1

For suspected Crohn’s disease (CD), with negative ileocolonoscopy and imaging studies (CE of small bowel)

Strong

Very low

2

For CD and clinical features unexplained by ileocolonoscopy or imaging studies

Strong

Very low

3

For CD, when assessment of small-bowel mucosal healing (beyond reach of ileocolonoscopy) is needed

Conditional

Very low

4

For suspected small-bowel recurrence of CD after colectomy, undiagnosed by ileocolonoscopy or imaging studies

Strong

Very low

7

For celiac disease with unexplained symptoms despite treatment and appropriate investigations

Strong

Very low (efficacy) Low (safety)

8

For documented overt gastrointestinal (GI) bleeding (excluding hemoatemesis) and negative findings on high-quality esophagogastroduodenoscopy (EGD) and colonoscopy

Strong

Very low

9

For overt, obscure bleeding episode, as soon as possible

Strong

Very low

10

With prior negative CE with repeated obscure bleeding, repeated studies (endoscopy, colonoscopy and/or CE)

Strong

Very low

11

For suspected obscure bleeding and unexplained mild chronic iron-deficiency anemia, in selected cases

Strong

Very low

12

For polyposis syndromes, which require small bowel studies, for ongoing surveillance

Conditional

Very low (efficacy) Low (safety)

 

Recommendations Against Use of CE

5

For diagnosing CD when chronic abdominal pain or diarrhea are only symptoms, and with no evidence of biomarkers associated with CD

Conditional

Low

6

For diagnosing celiac disease

Strong

Very low (efficacy) Low (safety)

13

For routine substitution of colonoscopy

Strong

Very low

14

For inflammatory bowel disease (IBD), as substitute for colonoscopy to assess extent and severity of disease

Strong

Very low (efficacy) Low (safety)

QOE: quality of evidence; Stmt: statement.

U.S. Multi-Society Task Force

The U.S. Multi-Society Task Force (2017) issued recommendations for colorectal cancer screening with representation from the American College of Gastroenterology, the American Gastroenterological Association, and The American Society for Gastrointestinal Endoscopy. Capsule endoscopy every 5 years received a tier 3 ranking with the following recommendation:

"We suggest that capsule colonoscopy (if available) is an appropriate screening test when patients decline colonoscopy, FIT, FIT-fecal DNA, CT colonography, and flexible sigmoidoscopy (weak recommendation, low-quality evidence)."

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force published its most recent recommendations for colorectal cancer screening in 2016. Colorectal cancer screening was recommended starting at age 50 years and continuing until age 75 years (A recommendation). Studies evaluating CE were not included in the evidence reviews in this report.

The U.S. Preventive Services Task Force is in the process of updating its recommendations for colorectal cancer screening.  The proposed analytic framework in the Draft Research Plan includes the evaluation of CE as a triage test for colonoscopy.

KEY WORDS:

Wireless capsule endoscopy, Given® Imaging System, camera endoscopy, ingestible video capsule, PillCam ESO, PillCam SB, Given® AGILE Patency System, patency capsule, CapsoCam Plus, Olympus Small Intestinal Capsule Endoscope System, MiroCam Capsule Endoscope System

APPROVED BY GOVERNING BODIES:

Table 18 summarizes various wireless CE devices with clearance by the U.S. Food and Drug Administration.

Table 18. Wireless Capsule Endoscopy Devices Cleared by the Food and Drug Administration

Device

Manufacturer

Date

Cleared

510(k)

No.

Indication

CapsoCam Plus (SV-3)

CapsoVision Inc.

4/19/2019

K183192

For visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

Olympus Small Intestinal Capsule Endoscope System

Olympus Medical Systems Corp

3/5/2019

K183053

For visualization of the small intestine mucosa.

MiroCam Capsule Endoscope System

IntroMedic Co. Ltd.

11/8/2018

K180732

May be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults and children from two years of age.

Olympus Small Intestinal Capsule Endoscope System

Olympus Medical Systems Corp.

3/13/2018

K173459

May be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.

PillCam Patency System

Given Imaging Ltd.

3/8/2018

K180171

Intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.

MiroCam Capsule Endoscope System

IntroMedic Co. Ltd.

1/30/2018

K170438

For visualization of the small intestine mucosa.

PillCam SBC capsule endoscopy system PilCam Desktop Software 9.0

Given Imaging Ltd.

9/1/2017

K170210

For visualization of the small intestine mucosa.

RAPID Web

Given Imaging Ltd.

5/26/2017

K170839

Intended for visualization of the small bowel mucosa.

AdvanCE capsule endoscope delivery device

United States Endoscopy Group Inc.

3/10/2017

K163495

Intended for visualization of the small bowel mucosa.

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

OLYMPUS MEDICAL SYSTEMS CORP.

1/19/2017

K163069

Intended for visualization of the small bowel mucosa.

CapsoCam Plus (SV-3) Capsule Endoscope System

CapsoVision Inc

10/21/2016

K161773

Intended for visualization of the small bowel mucosa.

CapsoCam (SV-1)

CapsoVision Inc.

2/9/2016

K151635

For use in diagnosing disorders of the small bowel, esophagus, and colon.

PillCam TM COLON 2

Given® Imaging

01/14/2016

K153466

Detection of colon polyps in patients after an incomplete colonoscopy and a complete evaluation of the colon was not technically possible, and for detection of colon polyps in patients with evidence of GI bleeding of lower GI origin with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy or moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

MiroCam Capsule Endoscope System

INTROMEDIC CO. LTD

3/17/2015

K143663

Intended for visualization of the small bowel mucosa.

ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT

OLYMPUS MEDICAL SYSTEMS CORP.

2/8/2015

K142680

Intended for visualization of the small bowel mucosa.

GI: gastrointestinal

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits, group specific policy will supersede this policy when applicable.

ITS Home: Policy provisions apply.

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

91110              Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus through ileum, with interpretation and report
91111              Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus with interpretation and report
0355T            

Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report

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  33. 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.
  34. Enns RA, Hookey L, Armstrong D et al. Clinical Practice Guidelines for the Use of Video Capsule Endoscopy.. Gastroenterology, 2017 Jan 8;152(3).
  35. Enns RA, Hookey L, Armstrong D, et al. Clinical practice guidelines for the use of video capsule endoscopy. Gastroenterology. Feb 2017; 152(3):497-514.
  36. Force USPST, Bibbins-Domingo K, Grossman DC, et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. Jun 21 2016;315(23):2564-2575.
  37. 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):538-45.
  38. Gerson LB, Fidler JL, Cave DR, et al. ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding. Am J Gastroenterol. Sep 2015;110(9):1265-1287; quiz 1288.
  39. Gong, F., et al. Wireless Endoscopy, Gastrointest Endosc 2000; 51(6): 725-9.
  40. Gralnek IM, Ching JY, Maza I et al. Capsule endoscopy in acute upper gastrointestinal hemorrhage: a prospective cohort study. Endoscopy 2013; 45(1):12-9.
  41. Gurudu SR, Bruining DH, Acosta RD, et al. The role of endoscopy in the management of suspected small bowel bleeding. Gastrointest Endosc. Jun 30 2016.
  42. Gutkin E, Shalomov A, Hussain SA et al. Pillcam ESO((R)) is more accurate than clinical scoring systems in risk stratifying emergency room patients with acute upper gastrointestinal bleeding. Therap Adv Gastroenterol 2013; 6(3):193-8.
  43. 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.
  44. Haanstra JF, Al-Toma A, Dekker E, et al. Prevalance of small-bowel neoplasia in Lynch syndrome assessed by video capsule endoscopy. Gut. Oct 2015; 64(10):1578-1583.
  45. 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):826-32.
  46. Herrerias JM, et al. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointestinal Endoscopy, May 2008; 67(6): 902-909.
  47. Iddan, G., et al. Wireless Capsule Endoscopy, NATURE 2000; 405(6785); 417.
  48. 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. May 2014; 59(5):1036-1041.
  49. 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. Aug 28 2020.
  50. Koornstra JJ. Small bowel endoscopy in familial adenomatous polyposis and Lynch syndrome. Best Pract Res Clin Gastroenterol. Jun 2012; 26(3):359-368.
  51. 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. Aug 2017; 49(8):854-863.
  52. 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):983-92.
  53. 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.
  54. 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. Sep 2012; 44 Suppl 3:SE15-30.
  55. Lapalus MG, et al. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: A prospective comparative study of performance and tolerance. Endoscopy 2006; 38: 36-41.
  56. 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.
  57. Lewis BS. Small intestinal bleeding. Gastroenterol Clin North Am 2000; 29(1):67-95.
  58. Lichtenstein GR, Hanauer SB, Sandborn WJ, et al. Management of Crohn’s desease in adults. AM J Gastroenterol. Feb 2009; 104(2):465-483.;quiz 464, 484.
  59. Lichtenstein GR, Loftus EV, Isaacs KL et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults.. Am. J. Gastroenterol., 2018 Apr 4;113(4).
  60. 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.
  61. McCarty TR, Afinogenova Y, Njei B. Use of Wireless Capsule Endoscopy for the Diagnosis and Grading of Esophageal Varices in Patients With Portal Hypertension: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. Feb 2017; 51(2):174-182.
  62. Meron, Gavriel D. The development of the swallowable video capsule (M2A), Gastrointestinal Endoscopy, Vol. 52, No. 6, December 2000.
  63. Morgan DR, Malik PR, Romeo DP et al. Initial US evaluation of second generation capsule colonoscopy for detecting colon polyps. BMJ Open Gastroenterol. 2016; 3(1):e000089.
  64. Oliva S, Di Nardo G, Hassan C, et al. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot stydy. Endoscopy. Jun 2014; 46(6): 485-492.
  65. Parodi A, Vanbiervliet G, Hassan C, et al. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. May 26 2017.
  66. 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.
  67. Pilz JB, Portmann S, Peter S et al. Colon capsule endoscopy compared to conventional colonoscopy under routine screening conditions. BMC Gastroenterol 2010; 10:66.
  68. 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 three-year technical review.  Dig Dis Sci 2008; 53(10):2732-8.
  69. Raju GS, Gerson L, Das A et al. American Gastroenterological Association (AGA) Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology 2007; 133(5):1694-6.
  70. Raju GS, Gerson L, Das A et al. American Gastroenterological Association (AGA) Institute technical review on obscure gastrointestinal bleeding. Gastroenterology 2007; 133(5):1697-717.
  71. Ramirez FC, Akins R and 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; 68(1):25-31.
  72. Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. May 2015; 148(5):948-957 e942.
  73. 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):303-8.
  74. Rubio-Tapia A, Hill ID, Kelly CP, et al. ACG clinical guidelines: diagnosis and management of celiac disease. AM J Gastroenterol. May 2013; 108(5):656-676.
  75. Saito Y, Saito S, Oka S, et al. Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon: prospective, multicenter, open study. Gastrointest Endosc. Nov 2015; 82(5): 861-869.
  76. 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. Aug 2014; 26(8):894-901.
  77. Saurin JC, Pilleul F, Soussan EB, et al. Small-bowel capsule endoscopy diagnoses early and advanced neoplasms in asymptomatic patients with Lynch syndrome. Endoscopy. Dec 2010; 42(12):1057-1062.
  78. Schoofs N, Devière J and Van Gossum A.  PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: A prospective pilot study. Endoscopy 2006; 38(10):971-7.
  79. Sharma VK, et al. ICCE concensus for esophageal capsule endoscopy. Endoscopy 2005; 37(10): 1060-1064.
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  82. Spada C, et al. A novel diagnostic tool for detecting functional patency of the small bowel:  the Given Patency capsule. Endoscopy, September 2005; 37(9): 793-800.
  83. Spada C, et al. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. Journal of Clinical Gastroenterology, July 2007; 41(6): 576-582.
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POLICY HISTORY:

Medical Policy Group, September 7, 2001

Medical Policy Group, January 2003 (1)

Medical Policy Administration Committee, January 2003

Available for comment February 6-March 24, 2003

Available for comment December 16, 2003-January 29, 2004

Medical Policy Group, November 2005 (3)

Medical Review Committee, December 2005

Medical Policy Administration Committee, December 2005

Available for comment December 27, 2005-February 9, 2006

Medical Policy Group, December 2006 (3)

Medical Policy Group, October 2007 (3)

Medical Policy Administration Committee, October 2007

Available for comment October 20-December 3, 2007

Medical Policy Group, October 2008 (3)

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Group, June 2011 (3): Updated Policy Section

Medical Policy Administration Committee, June 2011

Available for comment June 23 – August 8, 2011

Medical Policy Group, October 2012 (3): 2012 Update to Key Points and References

Medical Policy Group, December 2012 (3): 2013 Coding Update – Verbiage change to Codes 91110 & 91111

Medical Policy Group, May 2013(3):  Updated References; no change in policy statement

Medical Policy Panel, August 2013

Medical Policy Group, August 2013 (3):  2013 Updates to Description, Policy Statement, Key Points and References; added additional investigational/non-covered indications; no changes in covered indications

Medical Policy Administration Committee, September 2013

Available for comment August 30 through October 13, 2013

Medical Policy Group, June 2014 (5): Added new code 0355T for 2014 quarterly coding update effective 7/1/2014.

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; policy statement updated to reflect expanding coverage for patients with an established diagnosis of Crohn 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 and adding portal hypertensive enteropathy and unexplained chronic abdominal pain to list of investigational indications

Medical Policy Administration Committee, November 2014

Available for comment October 27 through December 9, 2014

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4): Updates to Key Points, Approved Governing Bodies, and References. Policy statement clarified by including “recurrent or persistent” after obscure and also clarified a policy statement by adding “inconclusive”. Policy intent unchanged.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (4): Updates to Key Points, Approved Governing Bodies, and References.  Updated obscure GI bleeding verbiage in policy statements and throughout policy to suspected small bowel bleeding. Added small bowel follow through to list of diagnostics tests for Crohn’s disease. Updates did not change intent of policy.

Medical Policy Panel, November 2017

Medical Policy Group, December 2017 (4): Updates to Description, Key Points, and References. Removed policy statement for dates of service prior to October 1, 2014, Removed previous coding for CPT code G0262 deleted effective 01/01/2004, No change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018(4): Updates to Description, Key Points, and References.  No change to policy statements.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. Added Key Words: CapsoCam Plus, Olympus Small Intestinal Capsule Endoscope System, MiroCam Capsule Endoscope System. No change to Policy Statement.

Medical Policy Panel, December 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to include the following investigational indications: Evaluation of patients with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation, and Evaluation of patients following incomplete colonoscopy. Available for Comment: December 16, 2020 through January 30, 2021.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the

    patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

   4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent    

      therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.