Medical policy: Esophageal pH Monitoring

Número de política: MP 2.017

Fecha de entrada en vigor: 3/1/2026

Política

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

• Documentation of abnormal acid exposure in endoscopy-negative individuals being considered for surgical anti-reflux repair.
• Evaluation of individuals after anti-reflux surgery who are suspected of having ongoing abnormal reflux.
• Evaluation of individuals with either normal or equivocal endoscopic findings and reflux symptoms refractory to proton pump inhibitor therapy.
• Evaluation of refractory reflux in individuals with chest pain after cardiac evaluation and after a 1-month trial of proton pump inhibitor therapy.
• Evaluation of suspected otolaryngologic manifestations of gastroesophageal reflux disease (i.e., laryngitis, pharyngitis, chronic cough) in individuals that have failed to respond to at least 4 weeks of proton pump inhibitor therapy.
• Evaluation of concomitant gastroesophageal reflux disease in individuals with adult-onset, nonallergic asthma suspected of having reflux-induced asthma.

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

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

Twenty-four-hour catheter-based impedance pH monitoring may be considered investigational in individuals with established gastroesophageal reflux disease (GERD) on proton pump inhibitor (PPI) therapy, whose symptoms have not responded adequately to twice-daily PPI therapy, in order to define refractory GERD. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

*Esophageal pH monitoring systems should be used in accordance with FDA-approved indications and age ranges.

Directrices de la política

Manometry, when used for pH tip placement, should be considered part of the pH recording.

Cross-references:

• MP 2.053 Transesophageal endoscopic therapies for gastroesophageal reflux disease
• MP 5.033 Wireless capsule endoscopy for gastrointestinal (GI) disorders
• MP 5.047 Ingestible pH and pressure capsule

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

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 can also cause or contribute to some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia.

Diagnóstico 

Gastroesophageal reflux disease 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 nondiagnostic, 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 can identify reflux events in which the liquid is only slightly acidic or nonacidic.

Regulatory status

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 the FDA through the 510(k) process. Examples include the Bravo™ pH Monitoring System (Medtronic), the Sandhill Scientific MediaTec™ pH Probe (Sandhill Scientific), the ORION II Ambulatory pH Recorder (MMS), Medical Measurement Systems, and the STRIP ICC Catheter (Tonometrics). FDA product code: FTF. The ZepHr^® Reflux Monitoring System (Diversatek) is an impedance device to detect reflux. FDA product code: FFX.

Fundamento

Summary of evidence

For individuals who have GERD who receive catheter-based pH monitoring, the evidence includes various 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. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

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. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have GERD who receive impedance pH testing, the evidence includes cross-sectional studies evaluating test performance and diagnostic yield in different populations. Relevant outcomes are test validity, symptoms, and functional outcomes. Positive impedance pH 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. Some studies have shown higher positive test rates with impedance pH testing compared with 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 chain of evidence supporting the utility of the test is weak. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Información adicional

Clinical input obtained in 2010 has suggested that catheter-based and wireless pH monitoring may aid in the diagnosis of GERD in patients who have an uncertain diagnosis after clinical evaluation and endoscopy. Esophageal pH monitoring is not considered a standard diagnostic test for most patients with GERD, but there is strong clinical support for its use in selected subpopulations for certain indications. Clinical guidelines support pH testing for patients with GERD being considered for surgical intervention. Wireless pH monitoring measurements appear to correlate closely to catheter-based monitoring and may be more comfortable for patients or may be an option for patients unable to tolerate catheter-based monitoring.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas pólizas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Covered when medically necessary:

Investigational; therefore, not covered:

Referencias

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