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Medical Policy: 02.01.37
Original Effective Date: January 2009
Reviewed: October 2011
Revised:
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.
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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.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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0242T Gastrointestinal tract transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report
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91299 unlisted diagnostic gastroenterology procedure
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Selected References:
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Dickman R, Fass R. Ambulatory Esophageal pH Monitoring: New Directions. Dig Dis 2006; 24(3-4): 313-318.
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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). Also available: http://www.ecri.org.
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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.
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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.
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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.
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ECRI. SmartPill GI Monitoring System for Assessing Gastrointestinal Motility. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2011 May 10. (ECRI Hotline Response). Also available: http://222.ecri.org.
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Policy History:
Date Reason Action
October 2011 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 © 2010 American Medical Association. All Rights Reserved.
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