DESCRIPTION
An ingestible pH and pressure-sensing capsule (SmartPillŪ GI Monitoring System) is being developed as a means of evaluating gastric emptying. It has been 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 to diagnose gastroparesis. 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 the pH and pressure-sensing capsule (SmartPillŪ GI Monitoring System) does not measure 50% emptying time, it can be correlated with the 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. These other functions do not assess delayed gastric emptying, and are not evaluated in this policy.
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 disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic or post-surgical. 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 postprandial 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. Currently protocol and parameters are yet to be standardized for the gastric emptying scintigraphy.
POLICY
Measurement of gastric emptying using an Ingestible pH and pressure capsule is considered investigational for the indication of suspected gastroparesis.
ADDITIONAL INFORMATION
The available literature is minimal and does not determine the health outcome or efficacy and safety of using the pH pressure sensing capsule for the diagnosis of gastroparesis. Larger studies are needed that compare the results of the current conventional standard test for gastroparesis with those of the ingestible pH and pressure capsule.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2009). Ingestible pH and Pressure Capsule. (2.01.81). Retrieved October 29, 2009 from BlueWeb.
Donohoe, K., Maurer, A., Ziessman, H., Urbain, J., Royal, H., & Martin-Comin, J. (2009). Procedure guideline for adult solid-meal gastric-emptying study 3.0. Journal of Nuclear Medical Technology, 37 (3), 196 - 200. (Level 5 Evidence)
Hasler, W. (2007). Gastroparesis: symptoms, evalution, and treatment. Gastroenterology Clinic of North America, 36 (3), 619 - 647. (Level 5 Evidence)
Kuo, B., McCallum, R., Koch, K., Sitrin, M., Wo, J., Chey, W., et al. (2008). Comparison of gastric emptying of a non digestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Ailment Pharmacology Therapy, 27 (2), 186 - 196. (Level 2 Evidence)
National Guideline Clearinghouse. National Center for Primary Care. (2004 June). Procedure guideline for gastric emptying and motililty. Retrieved September 23, 2009 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=7084&string=gastroparesis
National Guideline Clearinghouse. National Center for Primary Care. (2004 November). American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Retrieved September 23, 2009 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=5979&string=gastroparesis
Parkman, H., Hasler, W., & Fisher, R. (2004). American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology, 127 (5), 1589 - 1591. (Level 5 Evidence)
Rao, S. (2007). Constipation: evaluation and treatment of colonic and anorectal motility disorders. Gastroenterology Clinic of North America, 36 (3), 687 - 711. (Level 5 Evidence)
U.S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053547. Retrieved September 23, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053547.pdf.
ORIGINAL EFFECTIVE DATE: 3/11/2010
MOST RECENT REVIEW DATE: 3/11/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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