CG-MED-02 Esophageal pH Monitoring

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

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:

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 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; Katz, 2022) published their clinical guideline for the diagnosis and management of gastroesophageal reflux disease. 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.

In 2022 the American Gastroenterological Association (AGA; Yadlapati, 2022b) published a clinical practice update on the personalized approach to the evaluation and management of GERD. In that document they provided the following:

BEST PRACTICE ADVICE 5: 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.
BEST PRACTICE ADVICE 6: 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.
BEST PRACTICE ADVICE 8: 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.
BEST PRACTICE ADVICE 9: 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).

The AGA published additional recommendations in 2022 for the clinical role of ambulatory reflux monitoring in PPI non-responders (Yadlapati, 2022a). This document was the result of a consensus conference using the RAND Appropriateness Method. The results they reported included:

In 2023, the AGA (Chen, 2023) published a clinical practice update on the diagnosis and management of extraesophageal gastroesophageal reflux disease. In that document that provided the following statements:

BEST PRACTICE ADVICE 3: Currently, there is no single diagnostic tool that can conclusively identify GER as the cause of EER symptoms. Determination of the contribution of GER to EER symptoms should be based on the global clinical impression derived from patients’ symptoms, response to GER therapy, and results of endoscopy and reflux testing.
BEST PRACTICE ADVICE 7: Initial testing to evaluate for reflux should be tailored to patients’ clinical presentation and can include upper endoscopy and ambulatory reflux monitoring studies of acid suppressive therapy.
BEST PRACTICE ADVICE 8: Testing can be considered for those with an established objective diagnosis of GERD who do not respond to high doses of acid suppression. Testing can include pH-impedance monitoring while on acid suppression to evaluate the role of ongoing acid or non-acid reflux.

They also note, “Ambulatory esophageal pH monitoring objectively defines reflux burden to facilitate a GERD diagnosis but does not determine if GERD is the cause of extraesophageal symptoms”

No strength of recommendation ratings were provided in either the Yadlapati (2022b) or the Chen (2023) recommendations.

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.

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Subject: Esophageal pH Monitoring
Guideline #: CG-MED-02	Publish Date: 10/01/2024
Status: Reviewed	Last Review Date: 08/08/2024

CPT
91034	Esophagus, gastroesophageal reflux test; with nasal catheter pH electrode(s) placement, recording, analysis and interpretation
91035	Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode 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)

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
Reviewed	08/08/2024	Medical Policy & Technology Assessment Committee (MPTAC) review. Revised References and Websites sections.
Revised	08/10/2023	MPTAC review. Revised formatting in Clinical Indications section. Added “when the criteria above have not been met” to NMN statement. Revised References sections.
Reviewed	08/11/2022	MPTAC review. Updated review date, References, Websites for Additional Information and History sections.
Reviewed	08/12/2021	MPTAC review. Updated review date, References, Websites for Additional Information and History sections.
Reviewed	08/13/2020	MPTAC review. Updated review date, References, Websites for Additional Information and History sections. Reformatted Coding section.
Reviewed	08/22/2019	MPTAC review. Updated review date, References, Websites for Additional Information and History sections.
Reviewed	09/13/2018	MPTAC review. Updated review date, References, Websites for Additional Information and History sections.
Reviewed	11/02/2017	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Minor format changes to the Clinical Indications section. Updated review date, References and History sections.
Reviewed	11/03/2016	Medical Policy & Technology Assessment Committee (MPTAC) review. Updated review date, References and History sections. Updated formatting in the Position Statement section.
Reviewed	11/05/2015	MPTAC review. Updated review date, References and History sections. Removed ICD-9 codes from Coding section.
Reviewed	11/13/2014	MPTAC review. Updated review date, References and History sections.
Revised	11/14/2013	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 Esophageal 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.
Reviewed	06/08/2006	MPTAC review. No change to position statement. Added reference to MED.00045 Wireless Esophageal pH Monitoring. Updated Reference and Coding sections.
	11/17/2005	Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised	07/14/2005	MPTAC 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	2.06.01	Esophageal pH Monitoring