Medical Policy: 02.01.37
Original Effective Date: January 2009
Reviewed: August 2015
Revised: January 2014
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The SmartPill GI Monitoring System® is manufactured by the SmartPill Corporation (Buffalo, NY, USA). It is an ingestible, wireless capsule approximately the size of a large vitamin pill equipped with sensors to measure pH, pressure, and temperature from the entire length of the gastrointestinal tract. The capsule, after being swallowed in the doctor's office, collects and transmits data using radiofrequency to a special external receiver worn by the patient. The disposable capsule is naturally excreted from the body within a day or two after ingestion and the study is completed. The patient returns the receiver to the physician, who can download the data to a computer to assess gastric acidity, gastric emptying and total gastrointestinal tract transit time.
The SmartPill GI Monitoring System® was approved in 2006 by the U.S. by the Food and Drug Administration (FDA) under the 510(k) process for the evaluation of patients with suspected delayed gastric emptying (gastroparesis). In 2009, the SmartPill version 2.0 was cleared for marketing to evaluate suspected motility disorders, to evaluate suspected gastroparesis, to evaluate for abnormalities in transit time in patients with chronic constipation, and to enable calculation of motility indices. It is not indicated for pediatric patients.
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 ( 2000) stated that colonic manometry "is not generally available and is not appropriate for most patients, except in research settings."
Evaluation of gastrointestinal motility using the SmartPill GI Monitoring System® is considered investigational for all conditions, including but not limited to gastroparesis.
The evidence to date on the clinical utility of this 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.
Colonic motility studies (colonic manometry) is considered investigational because the clinical utility has not been established.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
91112 Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report
- 91117: Colon motility (manometric) study, minimum 6 hours continuous recording (including provocation tests, eg, meal, intracolonic balloon distension, pharmacologic agents, if performed), with interpretation and report
Dickman R, Fass R. Ambulatory Esophageal pH Monitoring: New Directions. Dig Dis 2006; 24(3-4): 313-318.
Maqbool S, Parkman HP, Friendenberg FK. Wireless capsule motility: a comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit. Dig Dis Sci. 2009; 54(10):2167-74.
Rao SS, Kuo B, McCallum RW et al. Investigation of colonic and whole gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May; 7(5):537-44.
Camilleri M, Thorne NK, Ringel Y, et al. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010 Aug;22(8):874-82.
Tran K, Brun R, Kuo B. Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice. Ther Adv Gastroenterol. 2012 Jul;5(4):249-260.
BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Wireless motility capsule in the diagnosis and evaluation of gastroparesis or slow-transit constipation. June 2012 Medical Advisory Panel Meeting. Chicago, IL: BCBSA; June 2012.
- Bharucha A, Dorn S, et al. Americal Gastroenterological Association medical position statement on constipation. Gastroenterology. Jan 2013: 144(1):211-217.
Date Reason Action
October 2011 Annual review Policy renewed
October 2012 Annual review Policy renewed
September 2013 Annual review Policy revised
January 2014 Gastric Electrical Stimulation Content moved to 07.01.62
August 2014 Annual review Policy renewed
August 2015 Annual review Policy renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.