Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders

POLICY NUMBER

A.6.01.33

DESCRIPTION

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

Health and Health Outcome Disparities in Certain Populations

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

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

Wireless Capsule Endoscopy

Wireless capsule endoscopy (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 2 frames per second as peristalsis carries the capsule through the gastrointestinal tract. The average transit time from ingestion to evacuation is 24 hours. The device uses wireless radio transmission to send the images to a receiving recorder device that the patient wears around the waist. This receiving device also contains localizing antennae sensors that can roughly gauge where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.

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

Magnetic Capsule Endoscopy

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

The table below summarizes various wireless CE devices with clearance by the U.S. Food and Drug Administration (FDA).

Wireless Capsule Endoscopy Devices Cleared by the U.S. Food and Drug Administration

GI: gastrointestinal

POLICY

Wireless capsule endoscopyof the small bowel may be considered medically necessary for the following indications:

• Suspected small bowel bleeding, as evidenced by prior inconclusive upper and lower gastrointestinal (GI) endoscopic studies performed during the current episode of illness.

• Initial diagnosis in individuals with suspected Crohn disease without evidence of disease on conventional diagnostic tests such as small bowel follow-through and upper and lower endoscopy.

• In individuals 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.

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

Other indications for wireless capsule endoscopy are considered investigational, including but not limited to:

• Evaluation of individuals with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation.

• Evaluation of individuals following incomplete colonoscopy.

The patency capsule is considered investigational, including use to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy.

Magnetic capsule endoscopy is considered investigational for the evaluation of individuals with unexplained upper abdominal complaints and all other indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

5/16/2002: Approved by Medical Policy Advisory Committee (MPAC), Code Reference section 'Non-Covered Codes' completed, CPT code 76499 (There are no specific CPT codes for this procedure), ICD-9 diagnosis code 578.0, 578.1, 578.9

3/20/2003: Reviewed by MPAC, investigational status changed to medically necessary, Sources and Code Reference sections updated, HCPCS G0262 added

2/13/2004: Code Reference section updated, ICD-9 diagnosis code 280.0 added.

3/25/2004: Reviewed by MPAC, expanded Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel to medically necessary for the initial diagnosis in patients with suspected Crohn's disease without evidence of disease on conventional diagnostic tests such as small-bowel follow-through (SBFT), and upper and lower endoscopy, Wireless capsule endoscopy remains investigational as a technique to evaluate other gastrointestinal diseases not presenting with gastrointestinal bleeding, including, but not limited to celiac sprue, irritable bowel syndrome, small bowel neoplasm or intestinal polyposis syndrome. Description revised to be consistent with BCBSA policy # 6.01.33, Sources updated

5/18/2004: Code Reference section updated, "There are no specific CPT codes for this procedure" deleted, CPT code 91110 added, CPT code 76499 deleted 12-31-2003 statement added, ICD-9 procedure code 88.90 added, ICD-9 diagnosis codes 555.0, 555.1, 555.2, 555.9 added

9/1/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC) 7/27/2006. HCPC G0262 deleted from covered table

1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.

5/15/2007: Policy reviewed. Added medically necessary indication for surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome. Investigational indications clarified. CPT code 91111 moved to non-covered. ICD-9 code 211.2 added to covered table. Policy name changed to "Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel and Esophagus." Previously named "Wireless Capsule Endoscopy in Obscure Digestive Tract Bleeding"

7/19/2007: Reviewed and approved by MPAC.

7/14/2008: Policy statement added that the patency capsule system is considered investigational.

9/15/2008: Code reference section updated per the annual ICD-9 updates effective 10-1-2008.

8/19/2009: Policy statement updated to include the following indication as investigational: evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer as investigational. ICD-9 diagnosis codes 280.8, 280.9 and 759.6 added to covered table.

07/29/2011: Policy reviewed; no changes to policy statement. Deleted outdated references from Sources section.

09/25/2012: Added "performed during the current episode of illness" to the second bullet of the medically necessary policy statement.

01/07/2013: Added the following new 2013 CPT code to the Code Reference section: 91112.

04/19/2013: Deleted ICD-9 procedure code 88.90 from the Code Reference section.

10/30/2013: Policy statement updated to add ulcerative colitis, Lynch syndrome, and initial evaluation of patient with acute upper GI bleeding as investigational indications. Deleted CPT code 91112 from the Covered Codes table. Code moved to the Ingestible pH and Pressure Capsule medical policy.

02/02/2015: Policy reviewed; description updated regarding devices. Added "of the small bowel" to the medically necessary statement for clarification. Added medically necessary indication for patients with an established diagnosis of Crohn's disease, when there are unexpected change(s) in the course of disease or response to treatment, suggesting the initial diagnosis may be incorrect and re-examination may be indicated. Investigational policy statement updated to include the evaluation of other conditions not presenting with GI bleeding, including portal hypertensive enteropathy and unexplained chronic abdominal pain as investigational indications.

08/26/2015: Code Reference section updated for ICD-10. Added 0355T to the Investigational Codes table.

11/09/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.6.01.33 added.

01/24/2017: Policy title changed from "Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus and Colon" to "Wireless Capsule Endoscopy to Diagnose Disorders of the Small Bowel, Esophagus, and Colon." Policy description updated regarding devices. Medically necessary policy statement criteria updated to change "Obscure gastrointestinal bleeding suspected of being of small bowel origin" to "Suspected small bowel bleeding."

01/09/2018: Policy description updated. Policy statements unchanged.

01/09/2019: Policy title changed from "Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon" to "Wireless Capsule Endoscopy to Diagnose Disorders of the Small Bowel, Esophagus, and Colon." Policy description updated regarding devices. Investigational policy statement for other indications of wireless capsule endoscopy updated to add "risk for hereditary nonpolyposis colorectal cancer."

12/12/2019: Policy description updated regarding devices. Policy statements unchanged.

12/10/2021: Code Reference section updated to add new CPT code 91113, effective 01/01/2022.

01/06/2022: Policy description updated regarding devices. Added investigational criteria regarding patients with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation and for the evaluation of patients following incomplete colonoscopy. Policy Guidelines updated to remove information regarding obscure GI bleeding and to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

09/30/2022: Code Reference section updated to add new ICD-10 diagnosis code Q85.89, effective 10/01/2022.

01/17/2023: Policy title changed from "Wireless Capsule Endoscopy to Diagnose Disorders of the Small Bowel, Esophagus, and Colon" to "Wireless Capsule Endoscopy for Gastrointestinal (GI) Disorders." Policy description updated regarding health and health outcome disparities in certain populations, magnetic capsule endoscopy, and wireless capsule endoscopy devices. Policy section updated with minor wording changes and to add that magnetic capsule endoscopy is considered investigational for the evaluation of individuals with unexplained upper abdominal complaints and all other indications. Code Reference section updated to change "Covered" to "Medically Necessary" and to add CPT code 0651T as investigational. Removed deleted CPT code 0355T.

09/29/2023: Code Reference section updated to add new ICD-10 diagnosis code D13.9, effective 10/01/2023.

01/16/2024: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis code Q85.8.

02/14/2025: Policy description updated. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 6.01.33

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Investigational Codes

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