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GI Monitoring Systems for Assessing Gastric Motility

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 02.01.37 
Original Effective Date: January 2009 
Reviewed: August 2015 
Revised: January 2014 


Benefit Application
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.


Description: 

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."


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Prior Approval: 

 

Not applicable


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Policy: 

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.





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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

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Selected References: 

  • Dickman R, Fass R. Ambulatory Esophageal pH Monitoring: New Directions. Dig Dis 2006; 24(3-4): 313-318.
  • ECRI. SmartPill GI Monitoring System for Assessing Gastric Motility. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 March 14. 8 p. (ECRI Hotline Response).
  • Fox J, Foxx-Orenstein A. Gastroparesis. American College of Gastroenterology (ACG). [cited 2008 Jan 9].
  • 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.
  • ECRI. SmartPill GI Monitoring System for Assessing Gastrointestinal Motility. Plymouth Meeting (PA):ECRI Health Technology Information Service; 2011 May 10. (ECRI Hotline Response).
  • 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.

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Policy History: 

 

 

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


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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.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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