Latest Review Date: December 2023

Category: Radiology                                                             

POLICY:

Effective for dates of service on and after July 1, 2021:

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 ALL of the following:

• Must be experiencing gastrointestinal blood loss and anemia secondary to bleeding.
• Clinical documentation indicating less than normal hemoglobin and hematocrit values.
• 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 individuals 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 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.
4. For surveillance of the small bowel in individuals 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 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 individuals 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 individuals with acute upper GI bleeding.
• Evaluation of individuals with evidence of lower GI bleeding and major risks for colonoscopy or moderate sedation.
• Evaluation of individuals 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 investigational.

Magnetic capsule is considered investigational for the evaluation of individuals with unexplained upper abdominal complaints.

Effective for dates of service December 16, 2020 through June 30, 2021:

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.
• Clinical documentation indicating less than normal hemoglobin and hematocrit values.
• 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.
• 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 investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

The wireless capsule endoscopy (CE) uses a noninvasive device to visualize segments of the gastrointestinal (GI) tract. Patients 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 are interpreted.

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 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.

Magnetic Capsule Endoscopy

The U.S. Food and Drug Administration (FDA) approved a novel magnetically maneuvered CE system (NaviCam™; AnX Robotica, Inc.) in May 2020.2, 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.

KEY POINTS:

The most recent literature review was updated through November 6, 2023.

Summary of Evidence

Patients With Suspected GI Disorders

For individuals who have suspected small bowel bleeding (previously referred to as obscure gastrointestinal (GI) bleeding) who receive wireless capsule endoscopy (CE), the evidence includes numerous case series evaluating patients with a nondiagnostic standard workup and a randomized controlled trial (RCT). 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 Crohn disease (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, a systematic review, and a retrospective cohort study. 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. A retrospective cohort study demonstrated therapeutic management changes based on CE results. 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 the 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. Relevant outcomes are test validity, other test performance measures, symptoms, and change in disease status. Systematic reviews of studies of CE’s diagnostic performance for this indication have 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 that the technology results in an improvement in the net health outcome.

Acute Upper GI Bleeding

For individuals who have acute upper GI tract bleeding who receive wireless CE, the evidence includes RCTs and several cohort studies. Relevant outcomes are test validity, 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. Relevant outcomes are overall survival, disease-specific survival, test validity, test accuracy, 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 test accuracy, test validity, other test performance measures, symptoms, change in disease status, and resource utilization. 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 test accuracy,test validity, other test performance measures, symptoms, change in disease status, and resource utilization. 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.

Magnetic Capsule Endoscopy for Patients with Suspected Gastrointestinal Disorders

For individuals who have unexplained upper abdominal complaints who receive magnetic CE, the evidence includes diagnostic accuracy studies. Relevant outcomes are test validity, symptoms, change in disease status, and treatment-related morbidity. Studies evaluating the diagnostic characteristics of magnetic CE as compared to conventional gastroscopy in the target population have generally demonstrated similar accuracy, sensitivity, and specificity, with increases in patient preference and an acceptable safety profile with the magnetic CE approach. However, the diagnostic characteristics of magnetic CE are inadequate to substitute for other modalities or to triage patients to other modalities based on the current literature. Direct evidence of improved outcomes or a strong chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Gastroenterology

In 2013, the American College of Gastroenterology (ACG) 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). These guidelines were updated in 2023, with no mention of CE.

In 2018, the ACG updated its guidelines on the management of Crohn disease (CD) in adults. It makes 2 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%.”

In 2015, the ACG 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). As of November 2023, a guideline update is in progress. The 2015 guidelines made the following statements related to video CE  (see Table 1).

Table 1. 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.

In 2021, the ACG issued guidelines on colorectal cancer screening. They "suggest consideration of the following screening tests for individuals unable or unwilling to undergo a colonoscopy or FIT [fecal immunochemical testing]: flexible sigmoidoscopy, multitarget stool DNA test, CT [computed tomography] colongraphy, or colon capsule [capsule endoscopy]" (conditional recommendation, very low quality of evidence).

American Gastroenterological Association Institute

In 2017, the American Gastroenterological Association Institute issued guidelines on the use of CE. Table 2 summarizes themost relevant recommendations (not all recommendations are included).

Table 2. AGA 2017 Capsule Endoscopy Recommendations Statement number	Recommendation	Grade	QOE
Recommendations supporting the use of CE
1	For suspected 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 GI bleeding (excluding hematoemesis) and negative findings on high-quality 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 the 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 IBD, as substitute for colonoscopy to assess extent and severity of disease	Strong	Very low (efficacy) Low (safety)

AGA: American Gastroenterological Association; CD: Crohn disease; CE: capsule endoscopy; EGD: esophagogastroduodenoscopy; GI: gastrointestinal; IBD: inflammatorybowel disease; QOE: quality of evidence.

American Society of Gastrointestinal Endoscopy

In 2017, the American Society of Gastrointestinal Endoscopy 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 3).

Table 3. 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.

U.S. Multi-Society Task Force

The U.S. Multi-Society Task Force (2017) issued recommendations for colorectal cancer screening with representation from the ACG, 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)."

In tandem with the U.S. Preventative Services Task Force (USPSTF) 2021 recommendations, the Multi-Society Task Force released a focused update to these guidelines in 2021, however, no changes were made regarding CE.

U.S. Preventive Services Task Force Recommendations

The USPSTF published its most recent recommendations for colorectal cancer screening in 2021. Colorectal cancer screening was recommended starting at age 50 years and continuing until age 75 years (A recommendation) and in adults aged 45 to 49 years (B recommendation). The USPSTF recommendation for screening for colorectal cancer does not include serum tests, urine tests, or CE for colorectal cancer screening because of the limited available evidence on these tests and because other effective tests are available.

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, NaviCam, Magnetic Capsule Endoscopy

APPROVED BY GOVERNING BODIES:

Table 4 summarizes various wireless CE devices with clearance by the U.S. Food and Drug Administration.

Table 4. Wireless Capsule Endoscopy Devices Cleared by the Food and Drug Administration

Device	Manufacturer	Date Cleared	510(k) No.	Indication
Pillcam SB 3 Capsule Endoscopy System, Pillcam Software 9.0e	Given Imaging Ltd.	8/27/2021	K211684	For visualization of the small bowel mucosa. It may be used in the visualization and monitoring of: lesions that may indicate Crohn's disease not detected by upper and lower endoscopy; lesions that may be a source of obscure bleeding not detected by upper and lower endoscopy; lesions that may be potential causes of iron deficiency anemia not detected by upper and lower endoscopy.
NaviCam Stomach Capsule System	AnX Robotica, Inc.	5/22/2020	K203192	For visualization of the stomach of adults (≥22 years) with a body mass index <38. The system can be used in clinics and hospitals, including emergency room settings.
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: Special benefit consideration may apply.  Refer to member’s benefit plan. 

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
91113	Gastrointestinal tract imaging, intraluminal colon
0651T	Magnetically controlled capsule endoscopy, esophagus through stomach, including intraprocedural positioning of capsule, with interpretation and report

PREVIOUS CODING:

0355T

Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report (Deleted 12/31/2021)

REFERENCES:

1. American College of Gastroenterology (ACG). Guidelines: Diagnosis and management of Celiac disease. 2013; //gi.org/guideline/diagnosis-and-management-of-celiac-disease/.
2. American College of Gastroenterology Guidelines. 2023. //gi.org/guidelines/. 
3. Annese V, Daperno M, Rutter MD, et al. European evidence based consensus for endoscopy in inflammatory bowel disease. J Crohns Colitis. Dec 15 2013; 7(12):982-1018.
4. Appleyard, M., et al. Wireless-capsule diagnostic endoscopy for recurrent small bowel bleeding, The New England Journal of Medicine, Vol. 344:232-233, January 18, 2001.
5. ASGE Standards of Practice Committee, Gurudu SR, Bruining DH, et al. The role of endoscopy in the management of suspected smallbowel bleeding. Gastrointest Endosc. Jan 2017;85(1):22-31.
6. Baltes P, Bota M, Albert J, et al. PillCamColon2 after incomplete colonoscopy - A prospective multicenter study. World JGastroenterol. Aug 21 2018; 24(31): 3556-3566.
7. 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.
8. Bruining DH, Oliva S, Fleisher MR, et al. Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study. BMJ Open Gastroenterol. Jun 2020; 7(1).
9. Cash BD, Fleisher MR, Fern S, et al. Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study). Gut. Nov 2021; 70(11): 2115-2122.
10. Chandran S, Testro A, Urquhart P et al. Risk stratification of upper GI bleeding with an esophageal capsule. Gastrointest Endosc Jun 2013; 77(6):891-8.
11. Choi M, Lim S, Choi MG, et al. Effectiveness of capsule endoscopy compared with other diagnostic modalities in patients with small bowel Crohn's disease: a meta-analysis. Gut Liver. Jan 15 2017;11(1):62-72
12. Colli A, Gana JC, Turner D, et al. Capsule endoscopy for the diagnosis of oesophageal varices in people with chronic liver disease or portal vein thrombosis. Cochrane Database Syst Rev. Oct 01 2014;10:CD008760.
13. Cross A, Szoka N. SAGES NaviCam stomach capsule system. March 10, 2021. www.sages.org/publications/tavac/navicam-stomach-capsule-system/.
14. Davidson KW, Barry MJ, Mangione CM, et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. May 18 2021; 325(19): 1965-1977.
15. Denzer UW, Rösch T, Hoytat B, et al. Magnetically guided capsule versus conventional gastroscopy for upper abdominalcomplaints: a prospective blinded study. J Clin Gastroenterol. Feb 2015; 49(2): 101-7.
16. D'Haens G, Lowenberg M, Samaan MA, et al. Safety and Feasibility of Using the Second-Generation Pillcam Colon Capsule to Assess Active Colonic Crohn's Disease. Clin Gastroenterol Hepatol. Aug 2015;13(8):1480-1486 e3.
17. Elosua A, Rullan M, Rubio S, et al. Does capsule endoscopy impact clinical management in established Crohn's disease?. Dig Liver Dis. Jan 2022; 54(1): 118-124. 
18. 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.
19. Franco DL, Leighton JA, Gurudu SR. Approach to Incomplete Colonoscopy: New Techniques and Technologies.Gastroenterol Hepatol (N Y). Aug 2017; 13(8): 476-483.
20. 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.
21. 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.
22. Gurudu SR, Bruining DH, Acosta RD, et al. The role of endoscopy in the management of suspected small bowel bleeding. Gastrointest Endosc. Jan 2017; 85(1): 22-31.
23. 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 May 2013; 6(3):193-8.
24. Guturu P, Sagi SV, Ahn D et al. Capsule endoscopy with PILLCAM ESO for detecting esophageal varices: a meta-analysis. Minerva Gastroenterol Dietol Mar 2011; 57(1):1-11.
25. 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.
26. Hussey M, Holleran G, Stack R, et al. Same-day colon capsule endoscopy is a viable means to assess unexplored colonic segments after incomplete colonoscopy in selected patients. United European Gastroenterol J. Dec 2018; 6(10):1556-1562.
27. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. 
28. 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.
29. Joseph DA, King JB, Dowling NF, et al. Vital Signs: Colorectal Cancer Screening Test Use - United States, 2018. MMWRMorb Mortal Wkly Rep. Mar 13 2020; 69(10): 253-259.
30. 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. Jul 2021; 53(7): 713-721.
31. Kobaek-Larsen M, Kroijer R, Dyrvig AK, et al. Back-to-back colon capsule endoscopy and optical colonoscopy incolorectal cancer screening individuals. Colorectal Dis. Jun 2018; 20(6): 479-485.
32. Koornstra JJ. Small bowel endoscopy in familial adenomatous polyposis and Lynch syndrome. Best Pract Res Clin Gastroenterol. Jun 2012; 26(3):359-368.
33. 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.
34. 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 Nov 2012; 76(5):983-92.
35. 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 Feb 2013; 77(2):227-32.
36. 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.
37. 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 Sep 2012; 107(9):1370-6.
38. Liao Z, Hou X, Lin-Hu EQ, et al. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With ConventionalGastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. Sep 2016; 14(9): 1266-1273.e1.
39. 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); 481-517.
40. 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.
41. 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.
42. Negreanu L, Babiuc R, Bengus A, et al. PillCam Colon 2 capsule in patients unable or unwilling to undergo colonoscopy.World J Gastrointest Endosc. Nov 16 2013; 5(11): 559-67.
43. Nogales Ó, García-Lledó J, Luján M, et al. Therapeutic impact of colon capsule endoscopy with PillCam™ COLON 2 afterincomplete standard colonoscopy: a Spanish multicenter study. Rev Esp Enferm Dig. May 2017; 109(5): 322-327.
44. 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.
45. 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. Mar 2018; 87(3): 695-704.
46. Patel SG, May FP, Anderson JC, et al. Updates on Age to Start and Stop Colorectal Cancer Screening: RecommendationsFrom the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. Jan 2022; 162(1): 285-299.
47. Pioche M, de Leusse A, Filoche B, et al. Prospective multicenter evaluation of colon capsule examination indicated bycolonoscopy failure or anesthesia contraindication. Endoscopy. Oct 2012; 44(10): 911-6.
48. Rex DK, Boland CR, Dominitz JA, et al. Colorectal Cancer Screening: Recommendations for Physicians and PatientsFrom the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. Jul 2017; 153(1): 307-323.
49. 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 e2.
50. Rokkas T, Niv Y. The role of video capsule endoscopy in the diagnosis of celiac disease: a meta-analysis. Eur J Gastroenterol Hepatol Mar 2012; 24(3):303-8.
51. Rondonotti E, Borghi C, Mandelli G, et al. Accuracy of capsule colonoscopy and computed tomographic colonography inindividuals with positive results from the fecal occult blood test. Clin Gastroenterol Hepatol. Aug 2014; 12(8): 1303-10.
52. Rubio-Tapia A, Hill ID, Semrad C, et al. American College of Gastroenterology Guidelines Update: Diagnosis andManagement of Celiac Disease. Am J Gastroenterol. Jan 01 2023; 118(1): 59-76.
53. 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.
54. 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.
55. 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.
56. Shaukat A, Kahi CJ, Burke CA, et al. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. Mar 01 2021; 116(3): 458-479. 
57. Shi HY, Chan FKL, Higashimori A, et al. A prospective study on second-generation colon capsule endoscopy to detect mucosal lesions and disease activity in ulcerative colitis (with video). Gastrointest Endosc. Dec 2017;86(6):1139-1146 e1136.
58. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. May 2020; 70(3): 145-164.
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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.

Medical Policy Group, July 2021 (5): Policy Statement updated to include the following clarifying statement: Clinical documentation indicating less than normal hemoglobin and hematocrit values, no change to policy intent. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2021: 2022 Annual Coding Update. Added CPT code 91113 to the Current Coding section. Created Previous Coding section to include CPT 0355T.

Medical Policy Panel, December 2021

Medical Policy Group, December 2021 (5): Updates to Description, Key Points, Approved by Governing Bodies, U.S. Preventive Services Task Force Recommendations, and References. Current Coding Section updated to include CPT 0651T. Policy Statement updated to remove “not medically necessary,” no change to policy intent. Created a new policy statement for Magnetic capsule endoscopy (NaviCam). This procedure (0651T) was previously investigational effective for dates of service on or after 07/01/2021 per MP#495: Investigational Criteria. Available for Comment: January 01, 2022- February 15, 2022.

Medical Policy Group, March 2022 (5): Policy statement related to suspected small bowel bleeding updated to include “ALL of” for clarification. No change to policy intent.

Medical Policy Panel, December 2022

Medical Policy Group, December 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, U.S. Preventive Services Task Force Recommendations, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.

Medical Policy Panel, December 2023

Medical Policy Group, December 2023 (11): Updates to Policy section (removed old policy dates) Description, Key Points, Benefit Application, and References.

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.