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Medical Policy: 02.01.03
Original Effective Date: September 2004
Reviewed: April 2011
Revised: March 2006
Benefit Application
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.
Description:
Acid reflux is the cause of heartburn, acid regurgitation peptic esophagitis, and Barrett’s esophagus, and a cause of 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.
The 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, 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 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.
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Prior Approval:
Not applicable
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Policy:
Esophageal pH monitoring using a catheter-based system or 48-hour, 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
- Evaluation of patients after antireflux surgery who are suspected to have 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 one 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 at least one of the following clinical indications:
- unexplained apnea
- bradycardia
- refractory coughing or wheezing, stridor, or recurrent choking (aspiration)
- persistent or recurrent laryngitis
- recurrent pneumonia
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes;
- CPT 91034 Esophagus, gastroesophageal reflux test; with nasal catheter pH electrodes(s) placement
- CPT 91035 Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode placement
- CPT 43235 Upper gastroesophageal endoscopy
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Selected References:
- 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.
- Bothwell M, Phillips J, Bauer S. Upper esophageal pH monitoring of children with the Bravo pH capsule. Laryngoscope. 2004 Apr;114(4):786-8.
- 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.
- Lacy BE, Edwards S, Paquette L et al. Tolerability and clinical utility of the Bravo pH capsule in children. J Clin Gastroenterol. 2009; 43(6):514-19.
- 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.
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Policy History:
Date Reason Action
April 2011 Annual review Renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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