Medical Policy: 02.01.03
Original Effective Date: September 2004
Reviewed: September 2016
Revised: September 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Acid reflux is the cause of heartburn, acid regurgitation peptic esophagitis, and Barrett's esophagus, and can cause 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, of at least four weeks in adults and two weeks in infants, prior to the need for esophageal ph monitoring.
Esophageal ph Monitoring
Esophageal monitoring is done through the use of a tube with a pH electrode attached to its tip, which is then passed to 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.
Wireless Esophageal ph Monitoring
More recently, a catheter-free, temporarily implanted device (Bravo™ pH Monitoring System, marketed by 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 96 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.
Impedence ph Monitoring
Another technology closely related to pH monitoring is impedance-pH monitoring, which incorporates pH monitoring with measurement 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. The therapeutic treatment of an abnormal impedance test are unproven at this time. Therefore the need for testing is not proven at this time.
Practice Guidelines and Position Statements
American Gastroenterology Association (2011)
The AGA's medical position statement on the management of Barrett's esophagus (2011) noted that "The guideline developers recommend against attempts to eliminate esophageal acid exposure (proton pump inhibitors [PPIs] in doses greater than once daily, esophageal pH monitoring to titrate PPI dosing, or antireflux surgery) for the prevention of esophageal adenocarcinoma (strong recommendation, moderate-quality evidence)".
American College of Gastroenterology (2007)
The ACG released practice guidelines on esophageal reflux testing. Impedance-pH monitoring was cited as “may be useful” for evaluation of patients with insufficient response to medical therapy. Current interpretation of impedance monitoring relies on use of symptom correlation measures (SI, SSI or SAP). The therapeutic implications of an abnormal impedance test are unproven at this time.
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES 2013)
Ambulatory reflux monitoring is not required in the presence of short or long-segment Barrett’s esophagus to establish a diagnosis of GERD. (Strong recommendation, moderate level of evidence).
Esophageal pH monitoring using a catheter-based system or catheter-free, wireless esophageal monitoring may be considered medically necessary for the following clinical indications in adults and adolescents, or children able to report symptoms:
- Documentation of abnormal acid exposure in endoscopy-negative patients being considered for surgical antireflux repair or
- Evaluation of patients after antireflux surgery who are suspected to have ongoing abnormal reflux or
- Evaluation of patients with either normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor therapy or
- Evaluation of refractory reflux in patients with chest pain after cardiac evaluation and after a one month trial of proton pump inhibitor therapy or
- 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 or
- Evaluation of concomitant GERD in an adult-onset, nonallergic asthmatic suspected of having reflux-induced asthma as a second line
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 at least one of the following clinical indications:
- unexplained apnea
- refractory coughing or wheezing, stridor, or recurrent choking (aspiration)
- persistent or recurrent laryngitis
- recurrent pneumonia
Esophageal pH monitoring is not medically necessary for all other indications, including, but not limited to any of the following indications because its effectiveness has not been established:
- To detect or verify reflux esophagitis or
- To verify GERD with Barrett's asophagus or
- To evaluate “alkaline reflux” or
- To titrate PPI dosing or manage patients that hae already been diagnosed with GERD.
- To titrate PPI dosing in the management of Barrett;s esophagus.
Regular use of catheter-based impedance-pH monitoring is considered not medically necessary. There is not evidence that the results of testing changes treatment. Currently only a very weak recommendation exists regarding further treatment after impedance-pH testing.
Esophageal impedance in combination with pH monitoring in the evaluation of GERD is not medically necessary. Given the lack of a criterion standard, evidence supporting the use of impedance-pH testing is inconclusive. Although impedance-pH testing may increase positive tests or diagnostic yield, the potentially increased sensitivity may be accompanied by a decrease in specificity and the net effect on patient management and patient outcomes is not certain. There is a lack of comparative studies showing that impedance-pH monitoring is more useful than existing techniques to diagnose and/or treat GERD. In patients with GERD symptoms refractory to PPI therapy, 24 hour pH testing, not impedance testing, is considered the gold standard method to diagnose/confirm reflux.
At this time, the limited studies on catheter based-pH monitoring are unable to show outcomes that prove there is an overall impact on clinical management as a first line surveillance tool.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes;
- 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
- 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)
- Pandolfino JE, Richter JE, Ours T, Guardino JM, Chapman J, Kahrilas PJ. Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol. 2003 Apr;98(4):740-9.
- American Gastroenterological Association Medical Position Statement: Guidelines on the Use of Esophageal pH Recording. Gastroenterology 1996 Jun;110(6):1981
- Ergun GA, Kahrilas PJ. Clinical applications of esophageal manometry and pH monitoring. Am J Gastroenterol 1996; 91(6):1077-89.
- Wong WM, Bautista J, et al. Feasibility and tolerability of transnasal/per-oral placement of the wireless pH capsule vs. traditional 24-h oesophageal pH monitoring--a randomized trial. Aliment Pharmacol Ther. 2005 Jan 15;21(2):155-63.
- Prakash C and Clouse RE. Value of extended recording time with wireless pH monitoring in evaluating gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2005 Apr;3(4):329-34.
- Bhat YM, McGrath KM, Bielefeldt K. Wireless esophageal pH monitoring: new technique means new questions. J Clin Gastroenterol. 2006 Feb;40(2):116-21.
- 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. 2011 Jan 16. doi:10.1111/j.1365-2982.
- Hong SK, Vaezi MF. Gastroesophageal reflux monitoring: pH (catheter and capsule) and impedance. Gastrointest Endosc Clin N Am. 2009;19(1):1-22.
- Hess T, Hahn EG, Konturek PC. BRAVO wireless 48 hour pH-metric system. Med Sci Monit. 2009;15(1):RA 17-RA 21.
- Petersen RP, Pellegrini CA, Oelschlager BK. Hiatal Hernia and Gastroesophageal Reflux Disease. In: Townsend: Sabiston Textbook of Surgery, 19th ed. Saunders, an imprint of Elsevier; 2012. Chapter 44.
- Grigolon A, Consonni D, Bravi I, et al. Diagnostic yield of 96-h wireless pH monitoring and usefulness in patients' management. Scand J Gastroenterol. 2011 May;46(5):522-30.
- Kleiman DA, Sporn MJ, Beninato T, Metz Y, et al. Early referral for 24-h esophageal pH monitoring may prevent unnecessary treatment with acid-reducing medications. Surg endosc. 2012 Dec 12. [Epub ahead of print]
- Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, et al. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness placation for the treatment of GERD by using multiple placation implants. Gastrointest Endosc. 2013 Jan;77(1):7-14.
- Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV, American Gastroenterological Association. American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-91.
- Richter, JE. Con: Impedance-pH testing does not commonly alter management of GERD. The American journal of gastroenterology. 104 (11) : 2667-9, 2009.
- Kavitt RT, Saritas E, et al. The role of impedance monitoring in patients with extraesophageal symptoms. 2013 Oct: 123(10):2463-2468.
- Frazzoni, M, Conigliaro, R, et al. The added value of quantitative analysis of on-therapy impedance-pH parameters in distinguishing refractory non-erosive reflux disease from functional heartburn. 2012 Feb: 24(2):141-e87.
- Hirano I., RichterJ., et al. ACG practice guidelines: esophagela reflux testing. (Am J Gastroenterol 2007;102:668–685).
- Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol 2013; 108(3):308-28.
- Philip O. Katz MD1, Lauren B. et al. Division of Gastroenterology, Einstein Medical Center, Philadelphia, Pennsylvania, USA; Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA; Division of Gastroenterology, Baylor College of Medicine & Michael E. DeBakey VA Medical Center, Houston, Texas, USA Am J Gastroenterol 2013; 108:308–328.
- Chen IL, Gao WY, Johnson AP, et al. Proton pump inhibitor use in infants: FDA reviewer experience. J Pediatr Gastroenterol Nutr 2012; 54:8.
- Funderburk A, Nawab U, Abraham S, et al. Temporal Association Between Reflux-like Behaviors and Gastroesophageal Reflux in Preterm and Term Infants. J Pediatr Gastroenterol Nutr 2016; 62:556
- del Genio G, Tolone S, del Genio F, et al. Total fundoplication controls acid and nonacid reflux: evaluation by pre- and postoperative 24-h pH-multichannel intraluminal impedance. Surg Endosc 2008; 22:2518.
- September 2016 - Annual Review, Policy Revised
- October 2015 - Annual Review, Policy Revised
- October 2014 - Annual Review, Policy Revised
- January 2014 - Annual Review, Policy Revised
- October 2013 - Interim Review, Policy Revised
- February 2013 - Annual Review, Policy Renewed
- February 2012 - Annual Review, Policy Revised
- April 2011 - Annual Review, Policy Renewed
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