DESCRIPTION
An ingestible pH and pressure-sensing capsule (e.g., SmartPill GI Monitoring System) measures pH, pressure, and temperature changes to signify the passage of the capsule through portions of the gastrointestinal tract. It is proposed as a means of evaluating gastric emptying for the diagnosis of gastroparesis, and colonic transit times for the diagnosis of slow transit constipation.
Once ingested, the device transmits data to an external receiver. 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. The capsule also measures pressure and temperature throughout its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal transit time. This technology is evaluated as a method to diagnosis suspected gastrointestinal (GI) motility disorders such as gastroparesis, intestinal dysmotility, and constipation.
POLICY
Measurements obtained via ingestible pH and pressure capsule for evaluation 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)
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
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.
SOURCES
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 from www.ahrq.gov.
American College of Gastroenterology. (2022, June). Clinical guideline: gastroparesis. Retrieved June 22, 2023 from http://gi.org.
American Gastroenterological Association. (2013). American Gastroenterological Association medical position statement on constipation. Retrieved October 18, 2017 from the http://www.gastrojournal.org.
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.
Bekkelund, M., Sangnes, D., Søfteland, E., Aabakken, L., Biermann, M., & Steinsvik, E., et al. (2021). Gastroparesis symptoms associated with intestinal hypomotility: an explorative study using wireless motility capsule. Clinical and Experimental Gastroenterology, 14, 133–144. (Level 4 evidence)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2021, September). Wireless gastrointestinal motility monitoring systems (LCD ID L33455). Retrieved April 11, 2022 from https://www.cms.gov.
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.
Sangnes, D.A., Søfteland, E., Bekkelund, M., Frey, J., Biermann, M., Gilja, O.H., et al. (2020). Wireless motility capsule compared with scintigraphy in the assessment of diabetic gastroparesis. Neurogastroenterology and Motility, 32 (4), e13771. (Level 4 evidence)
Triadafilopoulos, G. (2016). Utility of wireless motility capsule and lactulose breath testing in the evaluation of patients with chronic functional bloating. BMJ Open Gastroenterology, 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.
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.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, September; last update search October 2021). Wireless capsule systems for diagnosis of gastroparesis and monitoring of gastrointestinal motility. Retrieved April 11, 2022 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/11/2010
MOST RECENT REVIEW DATE: 8/10/2023
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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