Acid reflux is the cause of heartburn, acid regurgitation peptic esophagitis, and Barrett’s esophagus, as well as esophageal stricture, some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia. Gastroesophageal reflux disease (GERD) is usually diagnosed by clinical history and endoscopy, and is treated empirically with a trial of medical management.

Esophageal monitoring is done through the use of a tube with a pH electrode attached to its tip, which is then passed to almost exactly 5 cm above the upper margin of the lower esophageal sphincter (LES). The electrode is attached to a data logger 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. More recently, a catheter-free, temporarily implanted device (Bravo™ pH Monitoring System, Medtronic) has been approved by the U.S. Food and Drug Administration (FDA) for the purposes of esophageal monitoring. Using endoscopic or manometric guidance, the capsule is temporarily implanted in the esophageal mucosa using a pin. The capsule records pH levels for up to 48 hours and transmits them via radio frequency telemetry to a receiver worn in the patient’s belt. Data from the recorder are uploaded to a computer for analysis by a nurse or doctor.

Esophageal pH monitoring using a 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 patients being considered for surgical antireflux repair
• Evaluation of patients after antireflux surgery who are suspected of having ongoing abnormal reflux
• Evaluation of patients with either normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor therapy
• Evaluation of refractory reflux in patients with chest pain after cardiac evaluation and after a 1-month trial of proton pump inhibitor therapy
• Evaluation of suspected otolaryngologic manifestations of GERD (i.e., laryngitis, pharyngitis, chronic cough) that have failed to respond to at least 4 weeks of proton pump inhibitor therapy
• Evaluation of concomitant GERD in an adult-onset, nonallergic asthmatic suspected of having reflux-induced asthma

24-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.

48-hour, catheter-free, wireless esophageal monitoring is considered medically necessary for use in esophageal pH monitoring.

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

Beginning in 2005, 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.

The device may be placed with either endoscopic or manometry guidance.

In addition, a new code was developed for catheter-based monitoring:

91034: Esophagus, gastroesophageal reflux test; with nasal catheter pH electrode(s) placement, recording, analysis and interpretation

Prior to 2005, CPT codes 43235 (endoscopy) or 91010 (manometry) might be used, followed on a subsequent day with the code 91033 (esophageal pH monitoring), which represents the interpretation of the recorded measurements.

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity (i.e., 48-hour wireless pH monitoring)

Esophageal pH monitoring for 24 hours using catheter-based systems has been an established technology, primarily used in patients with gastroesophageal reflux disease (GERD) that has not responded symptomatically to a program of medical therapy (including proton pump inhibitors) or in patients with refractory extraesophageal symptoms. (1) This policy had been revised in 2003, with a specific focus on the availability of a wireless, catheter-free symptom, i.e., the Bravo pH monitoring system.

A 2006 TEC Special Report on Wireless Esophageal pH Monitoring  made the following conclusions on wireless monitoring:

• The procedure is successfully performed and produces successful measurement of esophageal acid in a high proportion of cases.
• Overall, it is more comfortable than traditional wired monitoring.

References:

1. ErgunGA, Kahrilas PJ. Clinical applications of esophageal manometry and pH monitoring. Am J Gastroenterol 1996; 91(6):1077-89.

Acid Reflux Test
Bravo pH Monitoring System
Esophageal pH Monitoring
Gastroesophageal Reflux Monitoring
Monitoring, Esophageal pH
pH Monitoring, Esophageal