Clinical UM Guideline

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

1. Documentation of abnormal esophageal acid exposure in endoscopy-negative individuals being considered for surgical antireflux repairs (pH study done after withholding antisecretory drug regimen for at least 1 week); or
2. Evaluation of antireflux surgery in individuals who are suspected to have ongoing abnormal reflux (pH study done after withholding antisecretory drug regimen for at least 1 week); or
3. Evaluation of individuals with either normal or equivocal endoscopic finding and reflux symptoms that are refractory to proton pump inhibitor (PPI) therapy (pH study after withholding antisecretory drug regimen for at least 1 week if the study is done to confirm excessive acid exposure or while taking the antisecretory drug regimen if the symptom-reflux correlation is to be scored); or
4. To detect refractory reflux in individuals with chest pain after cardiac evaluation using a symptom reflux association scheme, preferably the symptoms association probability calculation (pH study done after a trial of PPI therapy for at least 4 weeks); or
5. To evaluate an individual with suspected otolaryngologic manifestations (laryngitis, pharyngitis, chronic cough) of gastroesophageal reflux disease after symptoms have failed to respond to at least 4 weeks of PPI therapy (pH study done while the individual continues taking their antisecretory drug regimen to document the adequacy of therapy); or
6. To document concomitant gastroesophageal reflux disease in an adult onset, non-allergic asthmatic suspected of having reflux-induced asthma (pH study done after withholding antisecretory drugs for at least 1 week).

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

1. Unexplained apnea; or
2. Bradycardia; or
3. Refractory coughing, wheezing, stridor or recurrent choking (aspiration); or
4. Persistent or recurrent laryngitis; or
5. Recurrent pneumonia.

Not Medically Necessary: 

Esophageal pH monitoring is considered not medically necessary when the criteria above have not been met.

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.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or for situations designated in the Clinical Indications section as not medically necessary.

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.

In 2022 the American College of Gastroenterology (ACG) published their clinical guideline for the diagnosis and management of gastroesophageal reflux disease (Katz, 2022). In that document, they make the following suggestions:

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 prior pH monitoring study or an endoscopy showing long-segment Barrett’s esophagus or severe reflux esophagitis (Los Angeles 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)

An issue that frequently arises is whether esophageal pH monitoring should be performed on or off PPI therapy. It is generally recommended to monitor after PPIs are stopped for 7 days if the diagnosis of GERD is not clear, and prior to antireflux surgery or endoscopic therapy for GERD to document abnormal acid reflux [16]. This recommendation includes testing with either the telemetry capsule (48-96 hours) or impedance-pH catheter. Reflux monitoring while on PPI therapy is suggested in patients who have had the diagnosis of GERD established by previous objective evidence (i.e. erosive esophagitis, Barrett’s esophagus, prior pH testing off PPI) but who have symptoms potentially reflux-related that have not responded to PPIs. In these patients, impedance/pH testing is recommended to document reflux hypersensitivity for weakly acidic or non-acidic reflux as well as for acid reflux.

These suggestions are made on the basis of a low level of evidence.

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.

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.
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-hr esophageal pH monitoring- a randomized trial. Aliment Pharmacol Ther. 2005 15; 21(2):155-163.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Gastroenterological Association Medical Position Statement: Guidelines on the use of esophageal pH recording. Gastroenterology. 1996; 110(6):1981.
2. 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: https://www.cms.gov/. Accessed on August 7, 2023.
3. 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.
4. Gyawali CP, Carlson DA, Chen JW, et al. ACG clinical guidelines: Clinical use of esophageal physiologic testing. Am J Gastroenterol. 2020; 115(9):1412-1428.
5. Hirano I, Richter JE; Practice Parameters Committee of the American College of Gastroenterology. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol. 2007; 102(3):668-685.
6. Kahrilas PJ, Shaheen NJ, Vaezi MF, American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008; 135(4):1383-1391.
7. Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022; 117(1):27-56.

1. National Library of Medicine. Medical encyclopedia: Gastroesophageal reflux disease. Last update: June 9, 2021. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000265.htm. Accessed on August 7, 2023.

Bravo Capsule
Esophageal pH Monitoring
Gastroesophageal Reflux Disease (GERD)

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.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.