An ingestible pH and pressure-sensing capsule (e.g., SmartPill® GI Monitoring System) has been developed as a means of evaluating gastric emptying. The primary component is an ingestible wireless device that is equipped with pH, pressure, and temperature sensors. Once ingested, the device transmits pH, pressure, and temperature data to an external receiver that the individual wears as a belt. This device does not collect pictures. 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 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 gastrointestinal tract, allowing calculations of total gastrointestinal transit time. These other functions do not assess delayed gastric emptying, and are not evaluated in this policy. 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 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 individual 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.
Measurement obtained via ingestible pH and pressure capsule for evaluations of conditions including, but not limited to, the following is considered investigational:
Gastric emptying (e.g., gastroparesis)
Colonic transit times (e.g., gastric motility disorders, constipation)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The evidence to date is lacking on the clinical utility of testing. It is not possible to determine whether there is net improvement in health outcomes using wireless ingestible pH and pressure-sensing capsules versus standard diagnostic tests. Larger studies are needed that compare the results of the current conventional standard test for gastroparesis with those of the pH and pressure capsule.
Agency for Healthcare Research and Quality. (2013, May). Wireless motility capsule versus other diagnostic technologies for evaluating gastroparesis and constipation: a comparative effectiveness review. Retrieved February 17, 2016 fromwww.ahrq.gov.
American College of Gastroenterology. (2013, January).Clinical guideline: management of gastroparesis. Retrieved February 17, 2016 from http://gi.org/guideline/management-of-gastroparesis/.
American Gastroenterological Association. (2013). American Gastroenterological Association medical position statement on constipation. Retrieved October 18, 2017 from the http://www.gastrojournal.org/article/S0016-5085(12)01545-4/pdf.
Arora, Z., Parungao, J.M., Lopez, R., Heinlein, C., Santisi, J., & Birgisson, S. (2015). Clinical utility of wireless motility capsule in patients with suspected multiregional gastrointestinal dysmotility. Digestive Diseases and Sciences, 60 (5), 1350-1357. Abstract retrieved February 17, 2016 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2016). Ingestible pH and pressure capsule. (2.01.81). Retrieved November 23, 2016 from BlueWeb. (16 articles and/or guidelines reviewed)
Green, A.D., Belkind-Gerson, J., Surjanhata, B.C., Mousa, H., Kuo, B., & Di Lorenzo, C. (2013). Wireless motility capsule test in children with upper gastrointestinal symptoms. The Journal of Pediatrics, 162 (6), 1181-1187. Abstract retrieved February 17, 2016 from PubMed database.
Triadafilopoulos, G. (2016). Utility of wireless motility capsule and lactulose breath testing in the evaluation of patients with chronic functional bloating. BMJ Open Gastroenterology, 2016, 3: e000110. Doi:10.1136/bmjgast-2016-000110. (Level 4 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.
U.S. Food and Drug Administration. (2009, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092342. Retrieved August 16, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092342.pdf.
U.S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091405. Retrieved November 28, 2016 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K091405.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, September). Wireless capsule systems for diagnosis of gastroparesis and monitoring of gastrointestinal motility. Retrieved October 19, 2017 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines reviewed)
MOST RECENT REVIEW DATE: 11/9/2017
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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