Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    Gastrointestinal function testing using the following modalities is considered experimental and investigational:

a.    Cutaneous electrogastrography (EGG);

b.    Colonic motility studies utilizing colonic manometry;

c.    Ambulatory monitoring of gastric motility using, the SmartPill.

2.    There is not yet adequate published evidence that they are capable of adding any meaningful information to other conventional means of measuring gastric or colonic function.

1. Percutaneous Electrogastgrography (EGG) is considered experimental/Investigational as this approach has not been standardized for routine clinical use
2. Colonic manometry is considered experimental/investigational as its use has not been standardized for routine clinical use.
3. Wireless capsule for measuring gastric emptying parameters (SmartPill GI Monitoring System) is considered experimental and investigational because of inadequate published evidence of its diagnostic performance and clinical utility over conventional means of measuring gastric emptying.

Codes Used In This BI:

Cutaneous electrogastrography (EGG) is a noninvasive test that detects gastric arrhythmias by recording the frequency and regularity of gastric myoelectrical activity. It has been used to investigate the mechanisms of gastric motility and sensation in patients with gastric motility disorders or motion sickness. By means of surface electrodes, EGG records gastric myoelectrical activity from the surface of the body. The cutaneous signals are low in amplitude, and thus must be markedly amplified. The resultant signals are heavily contaminated with noise, and visual analysis alone of EGG signals is inadequate. Consequently, EGG recordings require special methodology for acquisition, processing and analysis.

Colonic motility studies are used to assess the flow of intraluminal contents, the motions of the colonic wall that induce flow, and the control systems that integrate and regulate these processes. The approaches employed have consisted of manometric techniques to record colonic contractions, barostatic methods to measure colonic tone, and recordings of myoelectric signals from the colon that initiate and control muscular contractions. However, the study of colonic motility in a clinical setting proves to be difficult. Accurate positioning of the probes via colonoscopy requires pre-procedure cleansing of the colon, which raises the possibility of altered physiology. In contrast to other segments of the gastrointestinal tract, contents move through the colon in hours or days, instead of seconds to minutes; thus, prolonged observations are needed. Moreover, in contrast to the upper gastrointestinal tract, in which reliable manometric recordings can be obtained, the larger diameter of the colon hinders the accurate detection of manometric events. And finally, all of these techniques, which continue to be used extensively in a research context, have not yet been standardized for routine clinical use.

An American Gastroenterological Association guideline on nausea and vomiting (AGA, 2001) concluded that “the place of such tests of motor function as gastric emptying studies, electrogastrography, and manometry have not been defined, and the yield of such diagnostic studies has not been adequately compared with a therapeutic trial of an antiemetic and/or prokinetic agents.” An American Gastroenterological Association guideline on constipation (AGA, 2000) stated that colonic manometry “is not generally available and is not appropriate for most patients, except in research settings.” The consensus opinion of the American Motility Society Clinical GI Motility Testing Task Force on the performance and clinical utility of EGG (Parkman et al, 2003) stated that no therapies have convincingly demonstrated in controlled studies that correcting abnormalities detected by EGG improves upper gastrointestinal symptoms. Proposed clinical indications for performance of EGG in patients with unexplained nausea, vomiting and dyspeptic symptoms must be validated by prospective controlled investigations

New approach for evaluating gastric motility function in patients with functional dyspepsia and other upper functional gastrointestinal disorders is the use of an ambulatory diagnostic test pill, the SmartPill (SmartPill Corporation; Buffalo, NY). On July 20, 2006, the Unites States Food and Drug Administration cleared the SmartPill GI Monitoring System through the 510(k) process for use as an aid in evaluating patients with suspected motility disorders such as gastroparesis. This wireless, ingestible, medical device assesses pH and pressure in the gastrointestinal lumen. When the capsule reaches the duodenum, the change in pH (from acidic to alkaline) indicates this transition, allowing an assessment of gastric emptying.

As it passes through the gastrointestinal tract, miniaturized sensor technology measures pressure, temperature, and pH, as well as real and elapsed time. Acquired data are continuously transmitted over very low power radiofrequencies to a small receiver that can be worn on the patient`s belt. Although the capsule normally has a transit time ranging from 24 to 48 hours, it is capable of transmitting data continuously for more than 72 hours in patients with reduced motility. Once the device has passed, the data set is downloaded from the receiver to a laptop computer, and special software provides tools for data analysis and a graphical user interface that indicates when gastric emptying, small bowel/large bowel transit, and total gastrointestinal tract transit time of the capsule has occurred.

Prospective, randomized, controlled trials are needed to ascertain the clinical value of the SmartPill. Furthermore, since the SmartPill itself does not empty like a meal from the stomach, the technology is likely to only provide an estimate of upper gastrointestinal transit.

Electrogastrography

1. Sanmiguel CP, Mintchev MP, Bowes KL. Electrogastrography: A noninvasive technique to evaluate gastric electrical activity. Can J Gastroenterol. 1998;12(6):423-430.
2. Levanon D, Chen JZ. Electrogastrography: Its role in managing gastric disorders. J Pediatr Gastroenterol Nutr. 1998;27(4):431-443.
3. Di Lorenzo C, Reddy SN, Flores AF, et al. Is electrogastrography a substitute for manometric studies in children with functional gastrointestinal disorders? Dig Dis Sci. 1997;42(11):2310-2316.
4. Atanassova E, Daskalov I, Dotsinsky I, et al. Non-invasive electrogastrography. Part 2. Human electrogastrogram. Arch Physiol Biochem. 1995;103(4):436-441.

Colonic motility studies:

1. American Gastroenterological Association (AGA). American Gastroenterological Association medical position statement: Nausea and vomiting. Gastroenterology. 2001;120(1): 261-263. Available at: http://www2.us.elsevierhealth.com/inst/serve?article=a123066&nav=abs
2. Drossman DA. Review article: An integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999;13(Suppl 2):3-14.
3. Bassotti G, Iantorno G, Fiorella S, et al. Colonic motility in man: Features in normal subjects and in patients with chronic idiopathic constipation. Am J Gastroenterol. 1999;94(7):1760-1770.
4. Altomare DF, Portincasa P, Rinaldi M, et al. Slow-transit constipation: Solitary symptom of a systemic gastrointestinal disease. Dis Colon Rectum. 1999;42(2):231-240.
5. Locke GR, Pemberton JH, Phillips SF. American Gastroenterological Association medical position statement: Guidelines on constipation. Gastroenterology. 2000;119(6):1761-1766.

Wireless Capsule for Measuring Gastric Emptying (SmartPill GI Monitoring System):

1. Kuo B, McCallum R, Kock K, et al. Smartpill, a novel ambulatory diagnostic test for measuring gastric emptying in healthy and disease. Gastroenterology. 2006;130:A-434.

2.      SmartPill Corp. Officially Launches its SmartPill GI Monitoring System. Available at: http://www.smartpillcorp.com/index.cfm?prid=36&pagepath=Home/NEWS_EVENTS/Press_Releases&id=416