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Medical Policy: 02.01.03
Original Effective Date: September 2004
Reviewed: March 2008
Revised: March 2006
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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.
Policy:
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 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
48-hour catheter-free, wireless esophageal monitoring may be considered medically necessary when at least one of the above criteria for pH monitoring are met.
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes;
- CPT code 91034 Esophagus, gastroesophageal reflux test; with nasal catheter pH electrodes(s) placement
- CPT code 91035 Esophagus, gastroesophageal reflux test; with mucosal attached telemetry pH electrode placement
- HCPCS code 43235; Upper gastroesophageal endoscopy
- CPT code 91010; Esophageal motility study (Manometric study of esophageal junction)
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Selected References:
- A review of the medical literature and recommendations from the Medical Policy Advisory Council (MPAC), which assists Wellmark's medical directors in the development of medical policies. MPAC is comprised of practicing physicians from Iowa and South Dakota.
- 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.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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.
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