Coverage Policy Manual
Policy #: 2009031
Category: Medicine
Initiated: September 2009
Last Review: February 2024
  Ingestible pH and Pressure Capsule and Gastric Emptying Breath Testing

Description:
An ingestible pH and pressure-sensing capsule (SmartPill® GI Monitoring System) is proposed as a means of evaluating gastric emptying - small bowel, colonic, and whole gut transit times. This technology is used to evaluate suspected gastrointestinal (GI) motility disorders such as gastroparesis, intestinal dysmotility, and constipation.
 
Gastroparesis is a chronic disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis are often nonspecific and may mimic other gastrointestinal (GI) tract disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic, or postsurgical.
 
The test considered the reference standard for gastroparesis is called gastric emptying scintigraphy. The patient ingests a radionuclide-labeled standard meal, and then images are performed at 0, 1, 2, and 4 hours postprandially to measure how much of the meal has passed beyond the stomach. A typical threshold to indicate abnormal gastric emptying is more than 10% of the meal remaining at 4 hours after ingestion.
 
Many patients with gastroparesis or symptoms of gastroparesis also have coexisting lower gut involvement. Testing for small and large bowel motility disorders includes manometry, colonic transit study, whole gut or colonic transit scintigraphy, radio-opaque markers and orocecal breath tests. These tests are often used in combination to assess symptoms of gastrointestinal dysmotility and for diagnostic evaluation.
 
Constipation is a chronic disorder involving infrequent bowel movements, sensation of obstruction, and incomplete evacuation. Many medical conditions can cause constipation such as mechanical obstruction, metabolic conditions, myopathies, and neuropathies. Diagnostic testing for constipation can aid in distinguishing between two categories of disorders, slow-transit constipation and pelvic floor dysfunction.
 
Standard tests used in the evaluation of constipation include ingestion of radio-opaque markers and colonic transit scintigraphy. In the radio-opaque markers test, small markers are ingested over one or several days, and abdominal x-rays are performed at 4 and/or 7 days. The number of remaining markers correlates with the colonic transit time. In colonic transit scintigraphy, a radio-labeled meal is ingested, followed by scintigraphic imaging at several time intervals. The location of the scintigraphic signals correlates with colonic transit times.
  
In 2006, an ingestible capsule (SmartPill® GI Monitoring System) was cleared for marketing by the U.S. Food and Drug Administration (FDA) via a 510(k) application, with the indication for use to evaluate delayed gastric emptying. Gastric emptying is signaled when the pH monitor in the capsule indicates a change in pH from the acidic environment of the stomach to the alkaline environment of the small intestine. While SmartPill does not measure 50% emptying time, it can be correlated with scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature throughout its transit through the entire GI tract, allowing calculations of total GI transit time. In 2009, the FDA expanded the use of the SmartPill to determine colonic transit time for the evaluation of chronic constipation and to differentiate between slow versus normal transit constipation. When colonic transit time cannot be determined, small and large bowel transit times combined can be used instead. The SmartPill is not for use in pediatric patients.
 
Note: The ingestible pH and pressure capsule (i.e., SmartPill®) measures pH, pressure and temperature changes to signify passage of the capsule through portions of the gastrointestinal tract. For example, an increase of 2 or more pH units usually indicates gastric emptying and a subsequent decrease of 1 or more pH units usually indicates passage to the ileocecal junction. This differs from esophageal pH monitoring for gastroesophageal reflux disease which measures pH levels in various ways such as through catheters, impedance or a temporarily implanted device such as the Bravo. The ingestible pH and pressure capsule (i.e., SmartPill®) also differs from the wireless capsule endoscopy (i.e., PillCam™) which is a capsule swallowed by the patient that transmits video images wirelessly.
 
Carbon-13 (denoted as 13C) breath testing has been used as an alternative to scintigraphy to assess and measure gastric emptying. The test is non-invasive and non-radioactive. The test is performed by ingestion of a test meal that includes Spirulina platensis, a naturally occurring plant-protein that is enriched with carbon-13.  Carbon-13 is normally found in exhaled carbon dioxide and can be measured in breath samples. After ingestion of the 13C labeled test meal, the expiratory 13-CO2 concentration is measured (by mass spectrometry or infrared spectroscopy) to determine the rate of gastric emptying.
 
Regulatory Status
In 2006, an ingestible capsule (SmartPill® GI Monitoring System; Given Imaging) was cleared for marketing by FDA via a 510(k) application, with the indication for use to evaluate delayed gastric emptying. Gastric emptying is signaled when the pH monitor in the capsule indicates a change in pH from the acidic environment of the stomach to the alkaline environment of the small intestine. While SmartPill does not measure 50% emptying time, it can be correlated with scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature throughout its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal tract transit time. In 2009, FDA expanded the use of the SmartPill to determine colonic transit time for the evaluation of chronic constipation and to differentiate between slow versus normal transit constipation. When colonic transit time cannot be determined, small and large bowel transit times combined can be used instead. The SmartPill is not for use in pediatric patients.
 
The ingestible pH and pressure capsule (ie, SmartPill®) measures pH, pressure, and temperature changes to signify passage of the capsule through portions of the gastrointestinal tract. For example, an increase of 2 or more pH units usually indicates gastric emptying, and a subsequent decrease of 1 or more pH units usually indicates passage to the ileocecal junction. This differs from esophageal pH monitoring for gastroesophageal reflux disease, which measures pH levels in various ways such as through catheters, impedance or a temporarily implanted device such as the Bravo. The ingestible pH and pressure capsule (ie, SmartPill®) also differs from the wireless capsule endoscopy (ie, PillCam™), which is a capsule swallowed by the patient that transmits video images wirelessly. FDA product code: NYV.
 
In April 2015, the spirulina 13C breath test was approved by the US Food and Drug Administration to diagnose gastroparesis. The Gastric Emptying Breath Test is conducted over a four-hour period after an overnight fast and is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. Patients have baseline breath tests conducted at the beginning of the test. They then eat a special test meal that includes a scrambled egg-mix and Spirulina platensis, a type of protein that has been enriched with carbon-13, which can be measured in breath samples
 
 
Wireless capsule endoscopy is discussed in the following separate policies:
 
2009021 Wireless Capsule Endoscopy in the Evaluation of Disorders of the Colon
2006018 Wireless Capsule Endoscopy in the Evaluation of Esophageal Disorders
2002008 Wireless Capsule Endoscopy, Small Bowel Study
 
Coding
Effective in 2013, there is a CPT category I code specific to this procedure:
 
91112: Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report.
  

Policy/
Coverage:
Effective February 2020
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule for the indication of suspected gastroparesis, constipation or other gastrointestinal motility disorders does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without Primary Coverage Criteria, measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule for the indication of suspected gastroparesis, constipation or other gastrointestinal motility disorders is considered investigational. Investigational services are exclusions in the member benefit certificate of coverage.
 
Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using gastric emptying breath testing (e.g., 13C Spirulina ®) for gastrointestinal motility disorders does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using gastric emptying breath testing (e.g., 13C Spirulina ®) for gastrointestinal motility disorders is considered investigational. Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective January 2012 - January 2020
Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule for the indication of suspected gastroparesis, constipation or other gastrointestinal motility disorders does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without Primary Coverage Criteria, measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule for the indication of suspected gastroparesis, constipation or other gastrointestinal motility disorders is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective prior to January 2012
Measurement of gastric emptying using an ingestible pH and pressure capsule for the indication of suspected gastroparesis does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without Primary Coverage Criteria, measurement of gastric emptying using an ingestible pH and pressure capsule for the indication of suspected gastroparesis is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.

Rationale:
Although gastric emptying scintigraphy is considered the reference standard for evaluating gastric emptying, several issues complicate its use as a reference test. Until recently, there has been a lack of standardization of the test (Abell, 2008).  Differences in the test meal used, patient positioning, frequency,  duration, and interpretation of imaging all limit the clinical utility of the test. Significant day-to-day variability in the rate of gastric emptying has been noted (Parkman, 2004).
 
There is limited knowledge regarding the capability of the gastric emptying test to discriminate between healthy individuals and those with known gastroparesis due to lack of standardization of the test and small patient samples in published studies. The study, which proposed a threshold of normality at 10% meal retention at 4 hours, included only 123 healthy subjects (Tougas, 2000).  The cutoff point was set to include 95% of normal persons. However, it appears to be unknown if this same threshold identifies adequately persons who would otherwise be classified as having gastroparesis and who are candidates or responders to treatment.
 
There are 2 published studies that evaluate the ingestible capsule in relation to another measure of gastric emptying. Cassilly et al evaluated the SmartPill and simultaneous gastric emptying scintigraphy in 15 healthy subjects (Cassilly, 2008).  The capsule was ingested immediately after ingesting the radiolabeled test meal. In this study, the mean time for 50% gastric emptying by scintigraphy was 95 minutes, 90% gastric emptying by scintigraphy was 194 minutes, and gastric residence time by SmartPill was 261 minutes. The correlation of SmartPill to 50% gastric emptying time was 0.606 and to 90% gastric emptying time was 0.565. The average amount of meal remaining in the stomach at the time the SmartPill exited the stomach was 5.4%. This study only shows modest correlation of the SmartPill and gastric emptying scintigraphy. The study is too small to establish reference values for the SmartPill.
 
In the other study by Kuo et al, 87 healthy subjects and 61 subjects with symptoms and prior positive test results for gastroparesis were evaluated with both the SmartPill and gastric emptying scintigraphy (Kuo, 2008).  In this study, subjects ingested the capsule just before ingesting the standard meal. This resulted in 5 subjects who passed the SmartPill in less than 30 minutes, who were then subsequently considered to have invalid tests. Sixteen other subjects had equipment malfunctions, and 2 others dropped out.
 
Among the remaining 125 subjects, the correlation of SmartPill emptying time and scintigraphy at 2 hours was 0.63, and between SmartPill emptying time and scintigraphy at 4 hours was 0.73. In terms of the capability to discriminate between gastroparetic patients and healthy subjects, the area under the curve (AUC) was 0.83 for SmartPill, 0.82 for scintigraphy at 4 hours, and 0.79 for scintigraphy at 2 hours (all p>0.05 for statistical significance), indicating similar capability for discriminating between the two patient groups. At a cutoff point of 300 minutes for the SmartPill, which was established by calculating the ideal cutoff point from the data, the sensitivity was 65% and specificity was 87%. The sensitivity and specificity for scintigraphy using an established cutoff point from the literature of 10% at 4 hours was 44% and 93%.
 
In terms of adverse events reported in the study by Kuo et al, 5 subjects of 67 who did not retrieve the capsule required a second additional plain x-ray beyond 5 days to demonstrate that the capsule had been passed. Another patient had ingested a laxative that caused the capsule to be entrapped in a viscous mass. An unsuccessful endoscopy and treatment with intravenous erythromycin was required to pass the capsule from the stomach.
 
These data have several shortcomings regarding the use of the SmartPill. Because of the change in the protocol for use of the SmartPill from ingesting the capsule before the standard meal to after the standard meal to avoid fast exit of the SmartPill from the stomach, the results of Kuo et al may no longer represent the performance of the device as it is now intended to be used. The cutoff point for sensitivity and specificity was not prespecified; using visual inspection to identify a cutoff point overestimates the diagnostic characteristics of the test. Although overall, the AUCs between the SmartPill and scintigraphy are similar, the modest correlation between the two tests means that there are often discordant results. What such discordant results mean in terms of diagnosis and treatment are uncertain. Overall, the data are scant regarding the diagnostic performance of the SmartPill.
 
Larger studies are needed that compare results with use of this device (using an established protocol and cutoff values) with the current standard test; such studies must define an appropriate gold standard for the diagnosis of gastroparesis. Evaluation of cases with discordant results would be of particular value. Ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes.
 
The U.S. Food and Drug Administration (FDA) has received one adverse event report according to their Web site, where the capsule was trapped in the stomach of a patient, which required endoscopic removal.
 
A 2008 consensus statement of the American Neurogastroenterology and Motility Society stated that the impact of wireless pressure and pH capsule on the management of patients with presumed upper GI dysmotility has not been studied (Camilleri, 2008).
 
The impact of this technology on net health outcome is unknown and does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
2012 Update
A review of the medical literature was conducted through November 2011. The following is a summary of the literature identified in this review.
 
Diagnostic Accuracy
One study was identified evaluating the diagnostic accuracy of the wireless pressure and pH capsule on colonic transit time. In 2010, Camilleri and colleagues compared the wireless motility capsule to radio-opaque markers in 158 patients with chronic functional constipation (Camilleri, 2010). In this multicenter validation study, the authors reported positive percent agreement between the wireless motility capsule and radio-opaque markers was approximately 80% for colon transit time (95% confidence interval [CI]: 0.67 – 0.98) and small and large bowel transit time (95% CI: 0.67 – 0.89). No serious adverse events occurred in the study.
 
Clinical Utility
Demonstration of clinical utility requires that the technology be associated with change(s) in management that lead to improved health outcomes. The evidence on the clinical utility of wireless pressure capsule is very limited, consisting of 2 retrospective analyses.
 
In a retrospective study of 83 patients evaluated for gastroparesis, small intestinal dysmotility and constipation, Kuo and colleagues found wireless motility capsule testing resulted in a new diagnosis in 44 patients (53%) (Kuo, 2011). Clinical management changes were recommended in 65 patients. These included changes in medication regimens in 39 patients (60%) and in nutrition programs in 9 patients (13.8%). Four patients (6.2%) were referred to surgery for colectomy. Abnormal gastric emptying or small intestinal transit times did not influence patient management at all (p=NS). Abnormal colon transit times did not influence nutritional program changes (p=0.72) but did influence medication changes (p=0.02) and resulted in a trend toward increased surgical referrals (p=0.12). The authors believe wireless motility capsule testing eliminated the need for nuclear gastric emptying testing in 9 of 52 patients (17.3%), barium radiography testing in 7 of 13 patients (53.8%), and radio-opaque marker testing in 41 of 60 patients (68.3%). The authors noted a need for prospective studies to further understand wireless motility capsule testing and its role in patient management.
 
In a retrospective study of 86 patients with persistent symptoms of gastrointestinal dysmotility, despite normal endoscopic and radiologic test results, Rao and colleagues found evaluations with wireless motility capsule testing resulted in new diagnostic information in 26 of 50 patients (53%) with lower gastrointestinal symptoms (LGI) and 17 of 36 patients (47%) with upper gastrointestinal symptoms (UGI) (Rao, 2011). Clinical management was influenced by wireless motility capsule testing in 30% of patients with LGI symptoms and in 50% of patients with UGI symptoms. The authors indicated the retrospective nature of this study limits interpretation of results.
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov in December 2011 found 3 open studies using a wireless motility capsule (SmartPill): the Colonic Transit Time Validation (CTT) study (NCT00857363), a study to assess gastric emptying speed in patients with diarrhea (NCT01114113) and a study to assess gastric acid output (NCT00702533).
 
Practice Guidelines and Position Statements
The American and European Neurogastroenterology and Motility Societies issued a position paper on gastrointestinal transit evaluation in 2011 (2011). In this position paper, the wireless motility capsule is recommended by consensus for assessing gastric emptying, small bowel, colonic, and whole gut transit times in patients with suspected gastroparesis or gastrointestinal dysmotility in multiple regions. However, the position paper notes the clinical utility of identifying delays in small bowel transit times is unknown.
 
The American Gastroenterological Association’s (AGA) medical position on gastroparesis diagnosis and treatment does not mention the wireless motility capsule (Parkman, 2004). Gastric emptying scintigraphy is considered the best accepted method to test for delays in gastric emptying. This position statement was created in 2004 and has not been updated. The AGA’s medical position on gastroesophageal reflux disease (GERD) indicates wireless pH monitoring may be used to evaluate suspected GERD when endoscopy is normal and manometry does not show any major abnormalities (Grade B: indicates recommended with fair evidence that it improves important outcomes) (Kahrilas, 2008).
 
Summary
An ingestible pH and pressure-sensing capsule (SmartPill® GI Monitoring System) is proposed as a means of evaluating gastric emptying time and small bowel, colonic, and whole gut transit times. This technology is used to evaluate suspected gastrointestinal motility disorders such as gastroparesis, intestinal dysmotility, and constipation. Available studies provide some information regarding the comparison of SmartPill to other techniques for measuring gastric emptying and whole-gut transit times, but this evidence primarily consists of concordance with available tests. Since the available tests, such as nuclear scintigraphy, are imperfect gold standards, it is not possible to determine the true sensitivity and specificity of SmartPill. The results of the concordance studies reveal a moderate correlation with alternative tests but provide only limited further information on the true accuracy of the test in clinical care. Evaluation of cases with discordant results would be of particular value, and ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes. The evidence to date on clinical utility of testing is lacking, consisting of a small number of retrospective studies. This does not provide sufficient information to determine whether health outcomes are improved as a result of the information provided by the SmartPill.
 
2013 Update
A literature search was conducted using the MEDLINE database through February 2013. There were no randomized controlled trials identified that would prompt a change in the coverage statement. A summary of the key identified literature is included below.
 
Gastric Emptying
A study by Maqbool et al. assessed SmartPill and gastric emptying scintigraphy in 10 healthy asymptomatic subjects (Maqbool, 2009). Emptying time assessed by SmartPill was correlated with the percent meal retained at 2 and 4 hours. The correlation between SmartPill and 2 hour scintigraphy was 0.95. The correlation between SmartPill and 4-hour scintigraphy was 0.70.
 
Colon Transit Time
Two studies evaluating the use of SmartPill for evaluating colonic transit times were identified. In one study by Maqbool et al., healthy asymptomatic individuals underwent simultaneous whole-gut scintigraphy and SmartPill assessment of whole gut transit times (Maqbool, 2009). The 2 techniques correlated with each other reasonably well. In another study by Rao et al., normal subjects and subjects with constipation had whole gut transit times assessed with radio-opaque markers and the SmartPill (Rao, 2009). The diagnostic accuracy of the 2 techniques in differentiating the 2 groups of patients was similar.
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov in February 2013 found 3 open studies evaluating the wireless motility capsule (SmartPill) as a diagnostic device: the Colonic Transit Time Validation (CTT) study (NCT00857363), a a study to assess gastric acid output (NCT00702533), and a study of gastrointestinal pressure patterns in children (NCT01026922). Some other studies were found in which SmartPill was used as a measurement instrument but its use was not the objective of the study. A study to assess gastric emptying speed in patients with diarrhea (NCT01114113), mentioned in the last policy update, has been withdrawn.
 
2014 Update
This policy was reviewed with a literature search through February 2014. The key identified literature is summarized below.
 
A 2013 systematic review of 12 studies on the ingestible capsule was published by the Agency for Healthcare Research and Quality (AHRQ) (Stein, 2013). While studies that included only healthy participants were excluded from the AHRQ review, studies were included in the review that used comparison groups consisting of healthy, asymptomatic (ie, without symptoms of gastroparesis or constipation) participants as controls, thus limiting interpretation of the comparisons. Overall, the strength of evidence in the available studies on the ingestible capsule was found to be low. Diagnostic accuracy with the ingestible capsule was considered comparable with gastric scintigraphy in 7 studies with diagnostic agreement ranging from 58% to 86% for test agreement when results were positive and 64% to 81% when test results were negative. There was moderate correlation between the ingestible capsule and gastric emptying scintigraphy on transit data and device agreement in 5 studies. Three studies that evaluated transit time reported similar sensitivity and specificity for the ingestible capsule and scintigraphy. The accuracy of the ingestible capsule in diagnosing slow-transit constipation was similar to tests using radiopaque markers and scintigraphy. Moderate correlation between colon transit times with the ingestible capsule and tests with radiopaque markers was shown in 5 studies with correlation coefficients ranging from 0.69 to 0.71. In addition the review found there was limited evidence available on the clinical impact of testing with the ingestible capsule (Stein, 2013). Therefore, the evidence was insufficient to draw conclusions regarding the impact of ingestible capsule testing results on treatment and management decisions.
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov on February 19, 2014 found 1 open study evaluating the wireless motility capsule (SmartPill) as a diagnostic device to assess gastric acid output (NCT00702533). The Colonic Transit Time Validation study (NCT00857363) and a study of gastrointestinal pressure patterns in children (NCT01026922) are listed as having an unknown recruitment status and have not been updated since 2010. Some other studies were found in which SmartPill was used as a measurement instrument, but its use was not the objective of the study.
 
Practice Guidelines and Position Statements
The American Gastroenterological Association’s 2013 (Camilleri, 2013). Gastric emptying scintigraphy is considered the best accepted method to test for delays in gastric emptying. medical position guidelines on gastroparesis diagnosis and treatment does not mention the indicate wireless motility capsule testing requires validation before it can be considered as an alternative to scintigraphy for diagnosing gastroparesis. (This position statement was created in 2004 and has not been updated).
   
2015 Update
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov on February 6, 2015 identified 1 ongoing clinical trial evaluating the diagnostic accuracy and/or clinical validity of an ingestible pH and pressure capsule:
 
Clinical Management with SPM (SmartPill Monitoring) System and Validation of the SPM 5 Hour Cutoff in Patients with Symptoms of Gastroparesis (NCT02022826): In this industry-sponsored trial, patients with gastroparesis for at least 12 weeks will undergo concurrent gastric scintigraphy and SmartPill monitoring. The primary study outcomes are per patient agreement between gastric emptying time with the 2 tests and per patient  greement for the diagnosis of delayed gastric emptying time. The  estimated date of study completion is July 2016.
 
The American College of Gastroenterology’s 2013 guideline on the management of gastroparesis stated T at wireless capsule motility testing and 13C breath testing require further validation before they can be considered alternates. (Conditional recommendation, moderate level of evidence) (Camilleri, 2013).
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2013 study by Green and colleagues assessed SmartPill and gastric emptying scintigraphy in 22 pediatric patients with severe upper gastrointestinal symptoms (green, 2013). Of 20 evaluable patients who had both tests, 9 patients had delayed gastric emptying identified by scintigraphy. SmartPill was 100% sensitive and 50% specific for delayed gastric emptying. Patients also underwent antroduodenal manometry (ADM) for detection of motor abnormalities. SmartPill identified motor abnormalities in 17 patients, compared with 10 detected by ADM. However, there does not appear to be a reference standard for motor abnormalities. Thus it cannot be determined whether SmartPill is more sensitive or has a higher false-positive rate for detection of motor abnormalities.
 
In a retrospective review of patients who underwent evaluation with SmartPill for suspected multiregional GI dysmotility, Arora and colleagues (2015) found abnormal test results in 109/161 (67.7%) of subjects (Arora, 2015). Multiregional dysmotility was diagnosed in 54 (49.5%) of patients. Although this study demonstrates a high yield of diagnosis among patients with a particular suspected condition, it does not demonstrate improved patient outcomes compared to standard tests.
 
February 2017
A literature search conducted using the MEDLINE database through February 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted using the MEDLINE database through February 2018. There was no new information added that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2020. The key identified literature is summarized below.
 
13C Breath Testing
Szarka et al (2008) published the results of a prospective, open-label comparative validation study of the [13C]-Spirulina platensis gastric emptying (GE) breath test (GEBT) with scintigraphy.  In this observational study, thirty-eight healthy volunteers and 129 patients with clinically suspected delayed gastric emptying underwent measurements at 45, 90, 120, 150, 180, and 240 minutes after a [13C]-S platensis and 0.5 mCi 99mTc labelled test meal. Normal ranges for scintigraphy were established for this test meal.  Intra- and inter-individual coefficients of variation (COVs), and the ability of the [13C] GEBT breath percent dose excreted *1000 values to predict scintigraphic half-life and to categorize GE as delayed, normal, or accelerated were also established. The researchers concluded that the 13C-Spiruline GEBT was as reproducible as scintigraphy.
 
American College of Gastroenterology (ACG)
The American College of Gastroenterology’s clinical guideline on “Management of gastroparesis” (Camilleri et al, 2013) noted that “Alternative approaches for assessment of gastric emptying include wireless capsule motility testing and 13C breath testing using octanoate or spirulina incorporated into a solid meal; they require further validation before they can be considered as alternates to scintigraphy for the diagnosis of gastroparesis”. (Conditional recommendation, moderate level of evidence).
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
0106UGastric emptying, serial collection of 7 timed breath specimens, non radioisotope carbon 13 (13C) spirulina substrate, analysis of each specimen by gas isotope ratio mass spectrometry, reported as rate of 13CO2 excretion
84999Unlisted chemistry procedure
91112Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report

References: Abell TL, Camilleri M, Donohoe K et al.(2008) Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol 2008; 36(1):44-54.

American College of Gastroenterology (ACG).(2013) Clinical guideline: management of gastroparesis. http://www.gi.org.

Arora Z, Parungao JM, Lopez R, et al.(2015) Clinical utility of wireless motility capsule in patients with suspected multiregional gastrointestinal dysmotility. Dig Dis Sci. May 2015;60(5):1350-1357. PMID 25399332

Camilleri M, Bharucha AE, di Lorenzo C et al.(2008) American Neurogastroenterology and Motility Society consensus statement on intraluminal measurement of gastrointestinal and colonic motility in clinical practice Neurogastroenterol Motil 2008; 20(12):1269-82.

Camilleri M, Parkman HP, Shafi MA et al.(2013) Clinical guideline: management of gastroparesis. Am J Gastroenterol 2013; 108(1):18-37; quiz 38.

Camilleri M, Parkman HP, Shafi MA, et al.(2013) American College of Gastroenterology Clinical Guideline: Management of Gastroparesis. AM J Gastroenterol 2013; 108: 18-37; . 2012. PMID

Camilleri M, Thorne NK, Ringel Y et al.(2010) Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil 2010; 22(8):874-82, e233.

Cassilly D, Kantor S, Knight LC et al.(2008) Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil 2008; 20(4):311-9.

Kuo B, Maneerattanaporn M, Lee AA et al.(2011) Generalized transit delay on wireless motility capsule testing in patients with clinical suspicion of gastroparesis, small intestinal dysmotility, or slow transit constipation. Dig Dis Sci 2011; 56(10):2928-38.

Kuo B, McCallum RW, Koch KL et al.(2008) Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther 2008; 27(2):186-96.

Maqbool S, Parkman HP, Friedenberg FK.(2009) Wireless capsule motility: comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit. Dig Dis Sci 2009; 54(10):2167-74.

Parkman HP, Hasler WL, Fisher RS et al.(2004) American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology 2004; 127(5):1592-622.

Parkman HP, Hasler WL, Fisher RS.(2004) American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology 2004; 127(5):1589-91.

Rao SS, Camilleri M, Hasler WL et al.(2011) Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies. Neurogastroenterol Motil 2011; 23(1):8-23.

Rao SS, Kuo B, McCallum RW et al.(2009) Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol 2009; 7(5):537-44.

Rao SS, Mysore K, Attaluri A et al.(2011) Diagnostic utility of wireless motility capsule in gastrointestinal dysmotility. J Clin Gastroenterol 2011; 45(8):684-90.

Stein E, Berger Z, Hutfless S et al.(2013) Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: A Comparative Effectiveness Review. Rockville (MD): Agency for Healthcare Research and Quality; 2013.

Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR.(2008) A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.PMID: 18406670

Tougas G, Eaker EY, Abell TL et al.(2000) Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol 2000; 95(6):1456-62.

US Food and Drug Administration (FDA).(2015) Summary and effectiveness data: Gastric Emptying Breath Test (GEBT). http://www.fda.gov.


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