Latest Review Date: November 2024

Category: Medical                                                                 

POLICY:

Catheter-based impedance-pH monitoring is considered investigational.

Ambulatory Esophageal pH monitoring using a wireless or catheter based system may be considered medically necessary for the following clinical indications in adults and children or adolescents able to report symptoms:

• Documentation of abnormal acid exposure in endoscopy-negative individuals being considered for surgical antireflux repair;
• Evaluation of individuals after antireflux surgery who are suspected of having ongoing abnormal reflux;
• Evaluation of individuals with either normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor therapy;
• Evaluation of suspected otolaryngologic manifestations of GERD (i.e., laryngitis, pharyngitis, chronic cough) in individuals who have failed to respond to at least four weeks of proton pump inhibitor therapy;
• Evaluation of concomitant GERD in an adult-onset, nonallergic asthmatic suspected of having reflux-induced asthma.

Twenty-four-hour catheter-based esophageal pH monitoring may be considered medically necessary in infants or children who are unable to report or describe symptoms of reflux with:

• Unexplained apnea;
• Bradycardia;
• Refractory coughing or wheezing, stridor, or recurrent choking (aspiration);
• Persistent or recurrent laryngitis; and
• Recurrent pneumonia.

DESCRIPTION OF PROCEDURE OR SERVICE:

Esophageal pH monitoring, using wired or wireless devices, can record the pH of the lower esophagus for a period of several days. Impedance pH monitoring measures electrical impedance in the esophagus to evaluate reflux episodes concurrent with changes in pH. These tests are used for certain clinical indications in the evaluation of gastroesophageal reflux disease (GERD).

Gastroesophageal Reflux Disease

Acid reflux is the cause of heartburn and acid regurgitation esophagitis, which can lead to esophageal stricture. Acid reflux may also be the cause or a contributing factor in some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia.

Diagnosis

Gastroesophageal reflux disease (GERD) is most commonly diagnosed by clinical evaluation and treated empirically with a trial of medical management. For patients who do not respond appropriately to medications, or who have recurrent chronic symptoms, endoscopy is indicated to confirm the diagnosis and assess the severity of reflux esophagitis. In some patients, endoscopy is non-diagnostic, or results are discordant with the clinical evaluation. In these cases, further diagnostic testing may be of benefit.

Monitoring

Esophageal monitoring is done using a tube with a pH electrode attached to its tip, which is then passed into the esophagus to approximately 5 cm above the upper margin of the lower esophageal sphincter. The electrode is attached to a data recorder worn on a waist belt or shoulder strap. Every instance of acid reflux, as well as its duration and pH, is recorded over a 24-hour period. Wireless pH monitoring is achieved using endoscopic or manometric guidance to attach the pH measuring capsule to the esophageal mucosa using a clip. The capsule records pH levels for up to 96 hours and transmits them via radiofrequency telemetry to a receiver worn on the patient’s belt. Data from the recorder are uploaded to a computer for analysis by a nurse or doctor.

Another technology closely related to pH monitoring is impedance-pH monitoring, which incorporates pH monitoring with measurements of impedance, a method of measuring reflux of liquid or gas of any pH. Multiple electrodes are placed along the length of the esophageal catheter. The impedance pattern detected can determine the direction of flow and the substance (liquid or gas). Impedance monitoring is able to identify reflux events in which the liquid is only slightly acidic or non-acidic.

KEY POINTS:

This most recent literature review was updated through September 16, 2024.

Summary of Evidence

For individuals who have gastroesophageal reflux disease (GERD) who receive catheter-based pH monitoring, the evidence includes cross-sectional studies evaluating test performance in different populations. Relevant outcomes are test validity, symptoms, and functional outcomes. Positive pH monitoring tests correlate with endoscopically defined GERD and with GERD symptoms, but because there is no reference standard for clinical GERD, diagnostic characteristics cannot be determined. There are no studies of clinical utility showing improved outcomes, and the chain of evidence supporting the utility of the test is weak. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive wireless pH monitoring, the evidence includes a systematic review and cross-sectional studies evaluating test performance and diagnostic yield in different populations. Relevant outcomes are test validity, symptoms, and functional outcomes. Positive wireless pH monitoring tests correlate with endoscopically defined GERD and GERD symptoms, but because there is no reference standard for clinical GERD, diagnostic characteristics cannot be determined. Some studies have shown higher positive test rates with prolonged wireless monitoring compared with catheter-based pH monitoring, but the effect of this finding on patient outcomes is uncertain. There are no studies of clinical utility showing improved outcomes, and the chain of evidence supporting the utility of the test is weak. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have GERD who receive impedance pH testing, the evidence includes cross-sectional studies in different populations evaluating test performance and diagnostic yield in different populations. Relevant outcomes include test validity, symptoms and functional outcomes. Positive impedance pH tests correlate with endoscopically defined GERD and with GERD symptoms, but since there is no reference standard for clinical GERD, diagnostic characteristics cannot be determined. Some studies show higher test positivity rates with impedance pH testing when compared to pH testing alone, but the effect of this finding on patient outcomes is uncertain. There are no studies of clinical utility showing improved outcomes, and the indirect chain of evidence supporting utility of the test is weak. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Gastroenterology

In 2020, the American College of Gastroenterology (ACG) released a clinical guideline on the clinical use of esophageal physiologic testing. The guideline conditionally recommends using prolonged wireless pH monitoring over catheter-based monitoring to diagnose gastroesophageal reflux disease (GERD) in adults with infrequent or day-to-day variations in esophageal symptoms. The recommendation is based on a very low quality of evidence. Wireless pH monitoring is especially beneficial in patients unable to tolerate a transnasal catheter or if a transnasal catheter yields negative results despite a high suspicion of GERD.

The ACG suggests using ambulatory pH impedance monitoring on proton pump inhibitor therapy over endoscopic evaluation or pH monitoring alone to diagnose persisting GERD in adults with typical esophageal reflux symptoms and previous confirmatory evidence of GERD (conditional recommendation, very low quality of evidence).

The ACG updated the guideline for the diagnosis and management of GERD in 2021 with recommendations supporting the use of pH monitoring to aid in the diagnosis of GERD as well as the management of refractory GERD. In the diagnosis of GERD, the ACG recommendations pertinent to pH testing include:

• "In patients who have chest pain without heartburn and who have had adequate evaluation to exclude heart disease, objective testing for GERD (endoscopy and/or reflux monitoring) is recommended (conditional recommendation, low level of evidence)."
• "In patients for whom the diagnosis of GERD is suspected but not clear, and endoscopy shows no objective evidence of GERD, we recommend reflux monitoring be performed off therapy to establish the diagnosis (strong recommendation, low level of evidence)."
• "We recommend against performing reflux monitoring off therapy solely as a diagnostic test for GERD in patients known to have endoscopic evidence of Los Angeles (LA) grade C or D reflux esophagitis or in patients with long-segment Barrett’s esophagus (strong recommendation, low level of evidence)."

For patients with refractory GERD the ACG recommends:

• "We suggest esophageal pH monitoring (Bravo, catheter-based, or combined impedance-pH monitoring) performed OFF PPIs if the diagnosis of GERD has not been established by a previous pH monitoring study or an endoscopy showing long-segment Barrett’s esophagus or severe reflux esophagitis (LA grade C or D) (conditional recommendation, low level of evidence)."
• "We suggest esophageal impedance-pH monitoring performed on PPIs for patients with an established diagnosis of GERD whose symptoms have not responded adequately to twice-daily PPI therapy (conditional recommendation, low level of evidence)."

American Gastroenterological Association

In 2022 the American Gastroenterological Association (AGA) updated recommendations for GERD and include reflux monitoring in their best practice advice as follows:

• "If PPI therapy is continued in a patient with unproven GERD, clinicians should evaluate the appropriateness and dosing within 12 months after initiation, and offer endoscopy with prolonged wireless reflux monitoring off PPI therapy to establish appropriateness of long-term PPI therapy."
• "If troublesome heartburn, regurgitation, and/or non-cardiac chest pain do not respond adequately to a PPI trial or when alarm symptoms exist, clinicians should investigate with endoscopy and, in the absence of erosive reflux disease (Los Angeles B or greater) or long-segment (≥3 cm) Barrett’s esophagus, perform prolonged wireless pH monitoring off medication (96-hour preferred if available) to confirm and phenotype GERD or to rule out GERD."
• "Clinicians should perform upfront objective reflux testing off medication (rather than an empiric PPI trial) in patients with isolated extra-esophageal symptoms and suspicion for reflux etiology."
• "In symptomatic patients with proven GERD, clinicians should consider ambulatory 24-hour pH impedance monitoring on PPI as an option to determine the mechanism of persisting esophageal symptoms despite therapy (if adequate expertise exists for interpretation)."

No strength of recommendation ratings were provided.

The AGA (2022) also developed recommendations for ambulatory reflux monitoring in patients with undiagnosed GERD persisting despite PPI therapy and in those with GERD who have inadequate PPI response. They recommend 96-hour wireless pH monitoring to determine future therapy and further diagnostic strategy in undiagnosed GERD. There was 100% committee agreement on wireless pH monitoring as the preferred diagnostic tool in patients with unproven GERD not responding to PPIs. In patients with established GERD, 24-hour impedance monitoring on PPI therapy was considered useful to define refractory GERD (88% committee agreement).

In 2023, the AGA released a clinical practice update on diagnosis and management of extraesophageal GERD. Patients with an established GERD diagnosis who do not respond to high-dose acid suppression can be considered for testing. The authors do not state a preference for a specific testing modality (impedance, catheter, and wireless capsule are all mentioned) but highlight that impedance testing can detect weakly acidic, nonacidic, and proximal reflux. Impedance monitoring is also the only specific testing modality that is noted for use while on acid suppression.

The Lyon Consensus

In 2018, an expert panel known as the Lyon Consensus provided GERD diagnosis recommendations that updated a prior consensus (the 2002 Porto consensus, published in 2004) and incorporated several prior consensus statements including Roman et al 2017 and Savarino et al 2017 (both summarized below). The Lyon Consensus was updated in 2023 to the 2.0 version. Changes from the prior version included providing comments on wireless pH monitoring and providing indications, nocturnal thresholds, and guidance for on-treatment use of pH-impedance monitoring. The 2.0 panel stated that prolonged wireless pH monitoring off antisecretory therapy is the preferred diagnostic tool in unproven GERD, and may be most effective when conducted for 96 hours. Diagnosis of unproven GERD may be aided by pH-impedance monitoring (off antisecretory therapy) when atypical symptoms are present (eg, excessive belching, rumination, pulmonary symptoms). pH-impedance testing while in PPI therapy is recommended for individuals with persistent GERD symptoms. The specific wireless pH monitoring acid exposure time threshold that is diagnostic for GERD is >6% on 2 or more days. Similarly, the ambulatory pH-impedance monitoring threshold (off PPI) that is diagnostic for GERD is >6% total acid exposure time. Refractory GERD is diagnosed with acid exposure time >4% and >80 reflux episodes per day while on an optimal antisecretory therapy.

International Consensus Group

In 2017, an international consensus group updated prior recommendations for GERD testing (the 2002 Porto consensus, published in 2004) to include statements on the role of ambulatory reflux monitoring in GERD diagnosis. Recommendations on the choice of GERD testing modality were based on moderate quality evidence or lower (none were supported by high quality evidence) and are as follows:

• Esophageal pH impedance monitoring may be indicated for patients with refractory symptoms despite PPI therapy, before and/or after antireflux surgery, and for some specific symptoms (i.e., cough, frequent belching, rumination syndrome).
• Wireless pH monitoring is indicated for patients who cannot tolerate pH catheters or who have a negative catheter pH study and ongoing symptoms.
• pH monitoring (catheter, wireless, or impedance) should be performed in most individuals at least 7 days after the last PPI dose. Impedance pH monitoring can be performed while the patient is taking a double-dose PPI if there is prior evidence of reflux such as prior pH testing, severe esophagitis, histology-proven Barrett's esophagus >1 cm, or peptic stricture.

International Working Group for Disorders of Gastrointestinal Motility and Function

In 2017, an expert consensus panel authored a statement on physiological assessment and diagnosis of GERD. The group's algorithm for assessing symptoms suggestive of GERD states that patients with atypical or alarming symptoms should first undergo endoscopy. Patients with documented reflux who do not respond to antireflux therapy should undergo ambulatory pH impedance monitoring while taking a PPI. Impedance pH testing is also indicated for patients without evidence of reflux who do not respond to empiric PPI therapy. Wireless pH monitoring is suggested for patients with negative 24-hour impedance pH monitoring who are still suspected of having GERD.

North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, et al

In 2018, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology Hepatology, and Nutrition (ESPGHAN) released a guideline on management of GERD in children.25, Based on expert opinion, the guideline strongly recommends using pH impedance monitoring to correlate troubling symptoms with acid reflux events. The guideline includes weak recommendations for pH impedance monitoring for clarifying the role of acid reflux in esophagitis and other GERD symptoms, clarifying the diagnosis in patients with normal endoscopy findings, and determining the effect of acid suppression therapy. If pH impedance monitoring is not available, the guideline strongly recommends that wireless pH monitoring be used only to correlate troubling symptoms with acid reflux events, confirm whether symptoms occur at the time of acid reflux events, and to determine the effect of acid suppression therapy. There is not enough evidence to support routine use of either pH monitoring technique for diagnosis of GERD in infants and children.

National Institute for Health and Care Excellence

In 2006, NICE released technology appraisal guidance on catheterless esophageal pH monitoring. This guidance indicates catheterless esophageal pH monitoring appears to be safe and effective and is commonly indicated for GERD symptoms refractory to PPIs and for GERD symptom recurrence after antireflux surgery.

In 2019, the Institute updated guidance on the diagnosis and management of GERD in children and young people.  The recommendations specific to esophageal pH monitoring included:

“Consider performing an esophageal pH study (or combined esophageal pH and impedance monitoring if available) in infants, children and young people with:

• suspected recurrent aspiration pneumonia
• unexplained apneas
• unexplained non‑epileptic seizure‑like events
• unexplained upper airway inflammation
• dental erosion associated with a neurodisability
• frequent otitis media
• a possible need for fundoplication
• a suspected diagnosis of Sandifer’s syndrome.

Consider performing an esophageal pH study without impedance monitoring in infants, children and young people if, using clinical judgement, it is thought necessary to ensure effective acid suppression.”

RAND Appropriateness Method Consensus

A National Institutes of Health-funded consensus panel comprised of United States physician experts that used a RAND/University of California Los Angeles appropriateness method (a modified Delphi method) to develop consensus statements regarding the clinical role of ambulatory reflux monitoring in patients with nonresponse to PPIs. The consensus recommendations were published in 2023. Recommendation statements were graded on a 9-point scale (scores of 1 to 3 were inappropriate, scores of 4 to 6 were uncertain appropriateness, and scores of 7 to 9 were appropriate). Recommendations were considered appropriate if the expected health benefit exceeded the expected negative consequences after taking into account the cost. Among the final 15 recommendation statements, 8 were appropriate and 7 were uncertain. The appropriate recommendations were as follows:

• Prolonged wireless pH monitoring off PPI is preferred for the diagnosis of unproven GERD and in patients with typical reflux symptoms not adequately controlled with single-dose PPI therapy.
• The preferred duration of wireless pH monitoring off acid suppression is 96 hours.
• An acid exposure time <4% on all days of monitoring and an overall negative symptom association does not support PPI therapy.
• An acid exposure time >6% across 2 or more days is diagnostic and supports treatment for GERD.
• An acid exposure time >10% across 2 or more days indicates severe acid burden and justifies escalating anti-reflux treatment.
• 24-hour pH impedance on PPI therapy is useful for diagnosing refractory GERD.
• In patients with proven GERD and lack of response to optimal PPI therapy, an acid exposure time <2% (on pH impedance monitoring and double-dose PPI therapy) and an overall negative symptom association, or <40 reflux events, does not support escalating anti-reflux treatment.
• In patients with proven GERD and lack of response to optimal PPI therapy, an acid exposure time >4% (on pH impedance monitoring and double-dose PPI therapy) and an overall positive symptom association supports escalating anti-reflux treatment.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Ambulatory esophageal pH monitoring, gastroesophageal reflux disease (GERD), Bravo capsule, impedance pH monitoring, wireless pH monitoring, Sandhill Scientific PediaTec pH Probe, ORION II Ambulatory pH Recorder, TRIP CIC Catheter

APPROVED BY GOVERNING BODIES:

Esophageal pH electrodes are considered class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements.

Several wireless and catheter-based (wired) esophageal pH monitoring devices have been cleared for marketing by FDA through the 510(k) process. Examples include the Bravo™ pH Monitoring System (Medtronic), the Sandhill Scientific PediaTec™ pH Probe (Sandhill Scientific [Highlands Ranch, CO]), the ORION II Ambulatory pH Recorder (MMS, Medical Measurement Systems [the Netherlands]), and the TRIP CIC Catheter (Tonometrics). The ZepHr® Reflux Monitoring System (Diversatek) is an impedance device to detect reflux.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT codes:

The following CPT code is used for catheter based monitoring:

91034

Esophagus, gastroesophageal reflux test; with nasal catheter pH electrode(s) placement, recording, analysis and interpretation

There is a specific CPT code for catheter free, wireless recording:

91035

Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode placement, recording, analysis and interpretation

Catheter based impedance pH monitoring to test esophageal function is reported with the following CPT codes:

91037	Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation;
91038	Esophageal 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)

                               

REFERENCES:

1. Bajbouj M, Becker V, Neuber M et al. Combined pH-metry/impedance monitoring increases the diagnostic yield in patients with atypical gastroesophageal reflux symptoms. Digestion 2007; 76(3-4):223-8.
2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Special Report: Wireless pH Monitoring. TEC Assessments 2006; 21(2).
3. Bredenoord AJ, Weusten BL, Timmer R et al. Addition of esophageal impedance monitoring to pH monitoring increases the yield of symptom association analysis in patients off PPI therapy. The Am J Gastroenterol Mar 2006; 101(3):453-9.
4. Chen JW, Vela MF, Peterson KA, et al. AGA Clinical Practice Update on the Diagnosis and Management of Extraesophageal Gastroesophageal Reflux Disease: Expert Review. Clin Gastroenterol Hepatol. Jun 2023; 21(6): 1414-1421.e3.
5. Garrean CP, Zhang Q, Gonsalves N et al. Acid reflux detection and symptom-reflux association using 4-day wireless pH recording combining 48-hour periods off and on PPI therapy. Am J Gastroenterol Jul 2008; 103(7):1631-7.
6. Grigolon A, Consonni D, Bravi I et al. Diagnostic yield of 96-h wireless pH monitoring and usefulness in patients' management. Scand J Gastroenterol May 2011; 46(5):522-30.
7. Gyawali CP, Yadlapati R, Fass R, et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. Jan 05 2024; 73(2): 361-371.
8. Gyawali CP, Yadlapati R, Fass R, et al. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. Sep 21 2023.
9. Gyawali CP, Carlson DA, Chen JW, et al. ACG Clinical Guidelines: Clinical Use of Esophageal Physiologic Testing. Am J Gastroenterol. Sep 2020; 115(9): 1412-1428.
10. Gyawali CP, Tutuian R, Zerbib F, et al. Value of pH Impedance Monitoring While on Twice-Daily Proton Pump Inhibitor Therapy to Identify Need for Escalation of Reflux Management. Gastroenterology. Nov 2021; 161(5): 1412-1422.
11. Gyawali CP, Kahrilas PJ, Savarino E, et al. Modern diagnosis of GERD: the Lyon Consensus. Gut. Jul 2018; 67(7): 1351-1362.
12. Hakanson BS, Berggren P, Granqvist S et al. Comparison of wireless 48-h (Bravo) versus traditional ambulatory 24-h esophageal pH monitoring. Scand J Gastroenterol. Dec 2009; 44(3):276-83.
13. Hirano I, Richter JE. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol 2007; 102(3):668-85.
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. Kahrilas PJ, Quigley EM. Clinical esophageal pH recording: a technical review for practice guideline development. Gastroenterology Jun1996; 110(6):1982-96.
16. Kahrilas PJ, Shaheen NJ, Vaezi MF et al. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology 2008; 135(4):1383-91, 91 e1-5.
17. Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. Jan 01 2022; 117(1): 27-56. 
18. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol 2013; 108(3):308-28; quiz 29.
19. Kessels SJM, Newton SS, Morona JK, et al. Safety and efficacy of wireless pH monitoring in patients suspected of gastroesophageal reflux disease: a systematic review. J Clin Gastroenterol. Oct 2017;51(9):777-788.
20. Mainie I, Tutuian R, Shay S et al. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut Oct 2006; 55(10):1398-402.
21. National Institute for Health and Care Excellence (NICE). Catheterless esophageal pH monitoring [IPG187]. 2006; www.nice.org.uk/Guidance/IPG187. 
22. National Institute for Health and Care Excellence (NICE). Gastro-oesophageal reflux disease in children and young people: diagnosis and management [NG1]. Updated October 9, 2019; www.nice.org.uk/guidance/ng1. 
23. Prakash C, Clouse RE. Value of extended recording time with wireless pH monitoring in evaluating gastroesophageal reflux disease. Clin Gastroenterol Hepatol Apr 2005; 3(4):329-34.
24. Roman S, Gyawali CP, Savarino E, et al. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. Oct 2017; 29(10): 1-15.
25. Rosen R, Vandenplas Y, Singendonk M, et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. Mar 2018; 66(3): 516-554.
26. Ruiz D, Pinto RA, Hull TL, et al. Does the radiofrequency procedure for fecal incontinence improve quality of life and incontinence at 1-year follow-up? Dis Colon Rectum. Jul 2010;53(7):1041-1046.
27. Savarino E, Bredenoord AJ, Fox M, et al. Expert consensus document: Advances in the physiological assessment and diagnosis of GERD. Nat Rev Gastroenterol Hepatol. Nov 2017; 14(11): 665-676.
28. Scarpulla G, Camilleri S, Galante P et al. The impact of prolonged pH measurements on the diagnosis of gastroesophageal reflux disease: 4-day wireless pH studies. Am J Gastroenterol Dec 2007; 102(12):2642-7.
29. Schneider JH, Kramer KM, Konigsrainer A et al. Ambulatory pH: monitoring with a wireless system. Surg Endosc Nov 2007; 21(11):2076-80.
30. Sweis R, Fox M, Anggiansah A, et al. Prolonged, wireless pH-studies have a high diagnostic yield in patients with reflux symptoms and negative 24-h catheter-based pH-studies. Neurogastroenterol Motil. May 2011; 23(5): 419-26.
31. Vela MF, Camacho-Lobato L, Srinivasan R et al. Simultaneous intraesophageal impedance and pH measurement of acid and nonacid gastroesophageal reflux: effect of omeprazole. Gastroenterology Jun 2001; 120(7):1599-606.
32. Wenner J, Johansson J, Johnsson F et al. Optimal thresholds and discriminatory power of 48-h wireless esophageal pH monitoring in the diagnosis of GERD. Am J Gastroenterol Sep 2007; 102(9):1862-9.
33. Yadlapati R, Gawron AJ, Gyawali CP, et al. Clinical role of ambulatory reflux monitoring in PPI non-responders: recommendation statements. Aliment Pharmacol Ther. Oct 2022; 56(8): 1274-1283. 
34. Yadlapati R, Gyawali CP, Pandolfino JE, et al. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review. Clin Gastroenterol Hepatol. May 2022; 20(5): 984-994.e1. 

POLICY HISTORY:

Medical Policy Group, September 2003

Medical Review Committee, September 2003

Medical Policy Administration Committee, October 2003

Available for comment October 16-December 1, 2003

Medical Policy Group, May 2004 (1)

Medical Policy Group, May 2005 (3)

Medical Policy Group, July 2006 (1)

Medical Policy Group, July 2008 (1)

Medical Policy Group, July 2010 (1) Policy statement updated for coverage of wireless pH monitoring, Key points updated

Medical Policy Administration Committee, June 2010

Available for comment June 18-August 2, 2010

Medical Policy Group, June 2011; Updated Description, Policy, Key Points, Approved by Gov. Bodies, References, and added codes from Investigational Listing 1/1/2005

Medical Policy Administration Committee, June 2011

Available for comment June 8 – July 25, 2011

Medical Policy Group, July 2012 (4): Updated Description, Policy section to add coverage for wireless and removed criteria for 48/96 hr testing, updated Key Points, References.

Medical Policy Administration Committee, July 2012.  

Available for comment July 26 through September 4, 2012

Medical Policy Panel, June 2013

Medical Policy Group, June 2013 (3): 2013 Updates to Policy, Key Points and References – policy statement wording change only – removed “24-hour” from in front of “catheter-based impedance-pH monitoring…”

Medical Policy Administration Committee July 2013

Available for comment July 12 through September 6, 2013

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (3): Updates to Key Points & References; no change in policy statement

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (4): Update to Key Points.  Moved CPT code 91299 from current coding to the previous coding section.  No change in policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (4): Updates to Description, Key Points, and Key Words.  Removed Effective for dates of service on or after January 1, 2005 through June 12, 2013.  No changes to policy statements.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points and References. Removed unlisted code 91299 from Previous Coding. No changes to policy statement or intent.  

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove “investigational,” no change to policy intent.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. Policy Statement updated to replace the word “patients” with the word “individuals,” and the words “24-hour” with “Twenty-four-hour.” No change in policy intent.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Key Points, Benefit Application, and References.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Key Points, and References. Policy Statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.

Esophageal pH monitoring for 24 hours using catheter-based systems is primarily used in patients with gastroesophageal reflux disease (GERD) that has not responded symptomatically to a program of medical therapy (including proton pump inhibitors [PPI]) or in patients with refractory extra-esophageal symptoms. Although it is an established technology, aspects of its use as a diagnostic test for GERD are problematic and thus make it difficult to determine its utility, as well as the utility of potential alternative tests.