Clinical UM Guideline


Subject:Esophageal pH Monitoring
Guideline #:  CG-MED-02Current Effective Date:  01/14/2014
Status:Revised Last Review Date:  11/14/2013

Description

This document addresses the use of standard catheter-based 24 hour and wireless– based 48 hour esophageal pH monitoring for all indications.

Clinical Indications

Medically Necessary:

Esophageal pH monitoring is considered medically necessary for the following adults, children or adolescents who are able to report their symptoms in the following clinical situations:

Esophageal pH monitoring is considered medically necessary in infants or children who are unable to report or describe symptoms of reflux with:

Not Medically Necessary:  

Esophageal pH monitoring is considered not medically necessary for any one of the following:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
91034Esophagus, gastroesophageal reflux test; with nasal catheter pH electrode(s) placement, recording, analysis and interpretation
91035Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode placement, recording, analysis and interpretation
91038Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation; prolonged (greater than 1 hour, up to 24 hours)
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
 All diagnoses
  
Discussion/General Information

Gastroesophageal reflux disease (GERD) is a disease where the lower esophageal sphincter that separates the esophagus from the stomach becomes weakened and allows acidic stomach contents to flow backwards into the esophagus. GERD is associated with heartburn, Barrett's esophagus, esophageal stricture, some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia.  GERD is usually diagnosed by clinical history and is typically treated initially with an empiric trial of PPI.  Individuals who do not respond to PPI therapy or present with more complex symptoms are often referred to endoscopy with pH monitoring for further evaluation.  The pH monitoring provides quantitative data on both esophageal acid exposure and on the temporal correlation between individual symptoms and reflux events. 

Conventional catheter-based pH monitoring involves the placement of a catheter with a pH electrode attached to its tip within the esophagus at 5 cm above the upper margin of the lower esophageal sphincter (LES).  The electrode is attached to an electronic data recorder worn on a waist belt or shoulder strap.  Every instance of acid reflux as well as its duration and pH is recorded, indicating gastric acid reflux over a 24-hour period.  Subjective symptoms are also manually reported in a patient log; these symptoms can then be temporally related to acid reflux events.

Non catheter based (i.e. wireless) devices have become available.  One such device is the Bravo™ capsule, which is attached to the esophageal wall during an endoscopy procedure.  The Bravo capsule contains a sensor that transmits pH data via radio waves to a small data collection device worn on the belt.  The Bravo capsule is naturally dislodged from the esophagus in a short period of time.  The sensor is then passed through the digestive tract.

Definitions

Endoscopy: An examination of the interior of a canal or hollow viscus by means of a special instrument, such as an endoscope. 

Esophageal pH Monitoring: A medical test that measures the acidity in the esophagus.

References

Peer Reviewed Publications:

  1. Ang D, Teo EK, Ang TL, et al. To Bravo or not? A comparison of wireless esophageal pH monitoring and conventional pH catheter to evaluate non-erosive gastroesophageal reflux disease in a multiracial Asian cohort. J Dig Dis. 2010; 11(1):19-27.
  2. Belafsky PC, Allen K, Castro-Del Rosario L, Roseman D. Wireless pH testing as an adjunct to unsedated transnasal esophagoscopy: the safety and efficacy of transnasal telemetry capsule placement. Otolaryngol Head Neck Surg. 2004; 131(1):26-28.
  3. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005; 100(1):190-200. Available at: http://www.acg.gi.org/physicians/guidelines/GERDTreatment.pdf. Accessed on September 12, 2013.
  4. Ergun GA, Kahrilas PJ. Clinical applications of esophageal manometry and pH monitoring. Am J Gastroenterol. 1996; 91(6):1077-1089.
  5. Pandolfino JE, Bianchi LK, Lee TJ, et al. Esophagogastric junction morphology predicts susceptibility to exercise-induced reflux. Am J Gastroenterol. 2004; 99(8):1430-1436.
  6. Pandolfino JE, Richter JE, Ours T, et al. Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol. 2003; 98(4):740-749.
  7. Pandolfino JE, Schreiner MA, Lee TJ, et al. Comparison of the Bravo wireless and Digitrapper catheter-based pH monitoring systems for measuring esophageal acid exposure. Am J Gastroenterol. 2005; 100(7):1466-1476.
  8. Prakash C, Clouse RE.  Value of extended recording time with wireless pH monitoring in evaluating gastroesophageal reflux disease.  Clin Gastroenterol Hepatol. 2005; 3(4):329-334.
  9. Tu CH, Lee YC, Wang HP, et al. Ambulatory esophageal pH monitoring by using a wireless system: a pilot study in Taiwan. Hepatogastroenterology. 2004; 51(60):1586-1589.
  10. Ward EM, Devault KR, Bouras EP, et al. Successful oesophageal pH monitoring with a catheter-free system. Aliment Pharmacol Ther. 2004; 19(4):449-454.
  11. Wenner J, Johnsson F, Johansson J, Oberg S. Wireless esophageal pH monitoring is better tolerated than the catheter-based technique: results from a randomized cross-over trial. Am J Gastroenterol. 2007: 102(2):239-245.
  12. Wong WM, Bautista J, Dekel R, et al. Feasibility and tolerability of transnasal/per-oral placement of the wireless pH capsule vs traditional 24-h oesophageal pH monitoring- a randomized trial. Aliment Pharmacol Ther. 2005 15; 21(2):155-163.

Government Agency, Medical Society, and Other Authoritative Publications: 

  1. American College of Gastroenterology (ACG). ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol. 2007; 102(3):668-685. Available at: http://www.gi.org/physicians/guidelines/EsophagealRefluxTesting.pdf. Accessed on September 12, 2013.
  2. American Gastroenterological Association Medical Position Statement: Guidelines on the use of esophageal pH recording. Gastroenterology. 1996; 110(6):1981. Available at: http://www.gastrojournal.org/article/S0016-5085(96)00240-5/abstract. Accessed on September 12, 2013.
  3. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008; 135(4):1383-1391. Available at: http://www.gastrojournal.org/article/S0016-5085(08)01606-5/fulltext. Accessed on September 12, 2013.
  4. Centers for Medicare and Medicaid Services. National Coverage Determination for 24-Hour Ambulatory Esophageal pH Monitoring. NCD #100.3. Effective June 11, 1985. Available at: http://www.cms.hhs.gov. Accessed on September 12, 2013.
  5. Chotiprashidi P, Liu J, Carpenter S, et al. ASGE Technology Status Evaluation Report: wireless esophageal pH monitoring system. Gastrointest Endosc. 2005; 62(4):485-487. Available at: http://www.asge.org/uploadedFiles/Publications_and_Products/Technology_Reviews/2005_wireless.pdf. Accessed on September 12, 2013. 
  6. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013; 108(3):308-328.
Web Sites for Additional Information
  1. National Library of Medicine. Medical encyclopedia: Gastroesophageal reflux disease. Last update:  08/11/2011. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000265.htm. Accessed on September 12, 2013.
Index

Bravo Capsule
Bravo pH Monitoring System
Esophageal pH Monitoring
Gastroesophageal Reflux Disease,
GERD
pH Monitoring, Esophageal

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.

History

Status

Date

Action

Revised

11/14/2013

Medical Policy & Technology Assessment Committee (MPTAC) review. In the not medically necessary criteria, added language to indicate esophageal pH monitoring is not medically necessary to establish a diagnosis of GERD in individuals with Barrett's esophagus. Updated review date, References and History sections.
Reviewed

11/08/2012

MPTAC review. Updated review date, References and History sections.
Reviewed

11/17/2011

MPTAC review. Updated review date, Coding, References and History sections.
Reviewed

11/18/2010

MPTAC review. Updated review date, References and History sections.
Reviewed

11/19/2009

MPTAC review.  Typographical error corrected in third bullet of the medical necessity criteria.  No change to the intent of the document.  Updated review date, Description, References and History sections. Removed Place of Service/Duration section.
Reviewed

11/20/2008

MPTAC review.  Updated review date, references and history sections.
Revised

11/29/2007

MPTAC review.  As a result of MED.00045 (Wireless Esohageal pH Monitoring) being archived, CG-MED-02 revised to address both catheter-based and wireless esophageal pH monitoring. Updated review date, Discussion/General Information, Coding, References and History sections. Title changed to "Esophageal pH Monitoring" in order to address both wireless and catheter-based esophageal pH monitoring.
 

10/01/2007

Updated coding section with 10/01/2007 ICD-9 changes.

Reviewed

05/17/2007

MPTAC review. No change to guideline position statement.  Updated Coding section; removed CPT 91033 deleted 12/31/2004.
Reviewed06/08/2006MPTAC review. No change to position statement. Added reference to MED.00045 Wireless Esophageal pH Monitoring. Updated Reference and Coding sections. 
 11/17/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised07/14/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 
Pre-Merger Organizations

Last Review Date

  Document Number

Title

Anthem, Inc.

 

 No document
WellPoint Health Networks, Inc.

09/23/2004

2.06.01Esophageal pH Monitoring