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Date Printed: August 18, 2017: 08:01 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative 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.

01-91000-08

Original Effective Date: 01/15/10

Reviewed: 04/27/17

Revised: 05/15/17

Next Review: No Longer Scheduled for Routine Review (NLR)

Subject: Ingestible pH and Pressure Capsule

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update    
           

DESCRIPTION:

An ingestible pH and pressure capsule (e.g., SmartPill GI Monitoring System) is proposed as a means of evaluating gastric emptying, small bowel, colonic and whole gut transit times. This technology is used to evaluate suspected gastrointestinal motility disorders such as gastroparesis, intestinal dysmotility and constipation.

The U.S. Food and Drug Administration (FDA) cleared the SmartPill GI Monitoring System for marketing via a 510(k) application. Indications for used states the SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis) and for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation.

The American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine consensus recommendations for gastric emptying scintigraphy state that gastric emptying scintigraphy is the standard for measurement of gastric emptying (2009).

The American Gastroenterological Association medical position statement for diagnosis and treatment of gastroparesis (2004), states that gastric emptying scintigraphy of a radiolabeled solid meal is the best accepted method to test for delayed gastric emptying.

POSITION STATEMENT:

Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule (e.g., SmartPill Monitoring System) is considered experimental or investigational for all indications, including the evaluation of gastroparesis, constipation and gastrointestinal motility disorders. The impact of measuring gastric emptying using an ingestible pH and pressure capsule on health outcome is unknown. The evidence is insufficient to determine whether health outcomes are improved as a result of the information provided by an ingestible pH and pressure capsule (e.g. SmartPill Monitoring System).

BILLING/CODING INFORMATION:

The following code may be used to describe gastrointestinal tract transit and pressure measurement via use of a wireless capsule.

CPT Coding:

91112

Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Gastroparesis: delayed gastric emptying.

RELATED GUIDELINES:

Esophageal pH Monitoring, 01-91000-01
Wireless Capsule Endoscopy, 01-91000-35

OTHER:

Other names use to describe SmartPill GI Monitoring System:

Note: The use of specific product names is illustrative 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.

Gastrointestinal motility system
Gastrointestinal pH and pressure monitoring equipment
SmartPill
Wireless GI motility monitoring
Wireless motility capsule

REFERENCES:

  1. Abell TL, Camilleri M, Donohoe K et al. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Journal of Nuclear Medicine Technology 2008; 36(1):44-54.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual-Ingestible pH and Pressure Capsule 2.01.81, 11/16.
  3. Camilleri M, Parkman HP,Shafi MA et al 2013. Clinical guideline: management of gastroparesis. American Journal of Gastroenterology 2013; 108(1): 18-37.
  4. Camilleri M, Thorne NK, Ringel Y et al. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterology & Motility 2010; 22(8): 874-882.
  5. Cassilly D, Kantor S, Knight LC, et al. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterology and Motility 2008 Apr; 20(4): 311-319.
  6. Kuo B, Maneerattanaporn M, Lee AA et al. Generalized transit delay on wireless motility capsule testing in patients with clinical suspicion of gastroparesis, small intestinal dysmotility, or slow transit constipation. Digestive Disease Science 2011; 56(10): 2928-38.
  7. Kuo B, McCallum RW, Koch KL et al. Comparison of gastric emptying of a nondigestible capsule to a radio-labeled meal in healthy and gastroparetic subjects. Alimentary Pharmacology & Therapeutics 2008; 27(2): 186-196.
  8. Maqbool S, Parkman HP, Friedenberg FK. Wireless capsule motility: comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit. Digestive Diseases and Sciences 2009; 54(10): 2167-2174.
  9. Parkman HP, Hasler WL, Fisher RS et al. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology 2004; 127(5): 1592-622.
  10. Parkman HP. Assessment of gastric emptying and small-bowel motility: scintigraphy, breath tests, manometry, and SmartPill. Gastrointestinal Endoscopy Clinics of North America 2009; 19(1): 49-55.
  11. Rao SS, Mysore K, Attaluri A et al. Diagnostic utility of wireless motility capsule in gastrointestinal dysmotility. Journal of Clinical Gastroenterology 2011; 45(8): 684-90.
  12. Rao SS, Camilleri M, Hasler WL et al. Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies. Neurogastroenterology and Motility 2011; 23(1): 8-23.
  13. Rao SS, Kuo B, McCallum RW et al. Investigation of colonic and whole gut transit with wireless motility capsule and radioopaque markers in constipation. Clinical Gastroenterology Hepatology 2009; 7(5):537-544.
  14. Sarosiek I, Selover KH, Katz LA et al. The assessment of regional gut transit times in health controls and patients with gastroparesis using wireless motility technology. Alimentary Pharmacolaogy and Therapeutics 2010; 31(2):313-322.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

01/15/10

New Medical Coverage Guideline.

12/15/10

Annual review. Maintain position statement. Updated references.

01/01/11

Annual HCPCS coding update; added 0242T.

02/15/12

Annual review. Maintain position statement (experimental or investigational); revised to include constipation and other gastrointestinal motility disorders and added statement “the impact of measuring gastric emptying using an ingestible pH and pressure capsule on health outcome is unknown.” Updated description and references.

01/01/13

Annual HCPCS coding update; deleted 0242T and added 91112.

03/15/13

Annual review; no change in position statement. Updated references.

06/15/14

Annual review; no change in position statement. Added Medicare Advantage products program exception Updated references.

05/15/17

Review; no change in position statement. Updated references.

Date Printed: August 18, 2017: 08:01 PM