MEDICAL POLICY SUBJECT: ESOPHAGEAL PH MONITORING. POLICY NUMBER: CATEGORY: Technology Assessment

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1 MEDICAL POLICY SUBJECT: ESOPHAGEAL PH MONITORING PAGE: 1 OF: 6 If the member's subscriber contract excludes coverage for a specific service it is not covered under that contract. In such cases, medical policy criteria are not applied. Medical policies apply to commercial and Safety Net products only when a contract benefit for the specific service exists. Medical policies only apply to Medicare products when a contract benefit exists and where there is no National or Local Medicare coverage decision for the specific service. POLICY STATEMENT: I. Based upon our criteria and assessment of peer-reviewed literature, catheter-based esophageal ph monitoring for adults and adolescents, or for children who are able to report symptoms, has been medically proven to be effective and is considered medically appropriate for any of the following indications: A. Documentation of abnormal acid exposure in endoscopy-negative patients who are being considered for surgical antireflux repair; B. Evaluation of patients after antireflux surgery who are suspected to have ongoing abnormal reflux; C. Evaluation of patients with normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor (PPI) therapy after a 4-week trial; D. Evaluation of refractory reflux in patients with chest pain after cardiac evaluation and a 4- week trial of PPI therapy; E. Evaluation of suspected otolaryngologic manifestations of GERD (e.g., laryngitis, pharyngitis, chronic cough) that have failed to respond to 4 weeks of PPI therapy; or F. Evaluation of concomitant GERD in an adult-onset, nonallergic asthmatic suspected of having reflux-induced asthma. II. Based upon our criteria and assessment of peer-reviewed literature, catheter-based esophageal ph monitoring has been medically proven effective and is considered medically appropriate in infants or children who are unable to report or describe symptoms of reflux for any of the following indications: A. Unexplained apnea; B. Bradycardia; C. Refractory coughing, wheezing or stridor; D. Recurrent choking or aspiration; E. Persistent or recurrent laryngitis; or F. Recurrent pneumonia. III. Based upon our criteria and assessment of peer-reviewed literature, a catheter-free or wireless esophageal ph monitoring system (e.g., BRAVO TM system by Medtronic) is considered medically appropriate as an alternative to the conventional, catheter-based method for those patients who meet the indications for the catheter-based monitoring. DESCRIPTION: Recurring reflux, or regurgitation of the stomach contents into the esophagus causes gastroesophageal reflux disease (GERD). GERD can lead to complications such as esophagitis, esophageal erosion, stricture and Barrett s esophagus (a premalignant condition). GERD is usually diagnosed by clinical history and is treated empirically with a trial of medical management. Esophageal ph monitoring is an important diagnostic test in the evaluation of those patients with GERD who require further evaluation if an adequate response to acid suppression therapy has not been achieved. Esophageal ph monitoring provides quantitative data on both esophageal acid exposure and the correlation between patient symptoms and reflux events. Conventional esophageal ph monitoring uses a tube or catheter with a ph electrode attached to its tip, which is passed orally/nasally to 5 cm above the upper margin of the lower esophageal sphincter. The catheter is then connected to a data A nonprofit independent licensee of the BlueCross BlueShield Association

2 PAGE: 2 OF: 6 recorder, which is attached to a waist belt or shoulder strap. The number of reflux events and the esophageal acid exposure time associated with each event is recorded and an event marker is activated in response to symptoms, meals and changes in body position. Additionally, patients are asked to keep a diary of symptoms and activities. The data recorded is compared with the diary information after the 24-hour monitoring period. A catheter-free or wireless diagnostic system for measuring esophageal ph levels has recently been developed. The wireless system consists of a ph sensor that is inserted either orally or nasally and temporarily attached to the esophageal wall with a pin mechanism after an endoscopic procedure for proper anatomical placement. Once activated, the sensor then monitors and transmits esophageal ph levels to an outside receiver worn by the patient for approximately 48 hours. As with the catheter-based method, the patient keeps a diary of symptoms and activities, which can be correlated with the data from the receiver. The sensor is spontaneously released from the esophageal wall and passes through the digestive tract within a few days. The wireless system has been marketed as a replacement for the catheter-based system. Catheter-based ph monitoring can be uncomfortable for some patients and some patients may restrict their activities and diet while the catheter is in place, leading to potentially false negative studies. The wireless system has been proposed to be more comfortable and less conspicuous for patient, thus allowing for more natural patient activities. The wireless system also allows a longer monitoring period of approximately 48 hours. RATIONALE: Esophageal ph monitoring using the catheter-based method: There are numerous catheter-based ph monitoring systems with FDA clearance. 24-hour, catheter-based esophageal monitoring is a well-established technology, primarily used in patients with GERD who have not responded symptomatically to a program of medical therapy, or in patients with refractory extraesophageal symptoms. The American Gastroenterological Association has published guidelines for the clinical use of esophageal ph recording. The sensitivity of the test is close to 96% with a specificity of %. Ambulatory 24-hour esophageal ph monitoring quantifies the degree of reflux in a near physiological setting and relates the patient s symptoms and activities to the occurrence of acid reflux events. Esophageal ph monitoring using the wireless method: BRAVO TM ph Monitoring System by Medtronic, a catheter-free or wireless system, received FDA 510 (k) clearance in September A recent comparison study between the 2 types of devices was conducted using 25 healthy volunteers (Pandolfino et al. 2005). All patients in the study underwent simultaneous ph monitoring using both devices. Of the 25 patients, data could not be analyzed on 7 patients- 6 patients experienced capsule displacement and 1 patient could not tolerate the catheter. Regarding available outcome data, the recorded acid exposure was similar between the 2 systems. Wong, et al. (2005) conducted a randomized study to compare the tolerability of the wireless ph capsule versus the traditional ph probe. 25 patients were randomized to each group. Though patients in the wireless capsule group experienced less nose, throat pain/discomfort then the traditional probe group, the wireless group had more chest and esophageal discomfort during the test. A case series by Ward et al. (2004) evaluated the use of the wireless ph monitoring system in 60 patients with GERD or noncardiac chest pain. All patients underwent esophageal endoscopy and attempted attachment of a wireless Bravo ph system. Immediately after attachment, capsule placement was assessed endoscopically. The results of the study showed that adequate diagnostic data were obtained in 97% of the cases. However, in 12% (n=7) of the patients, the initial implantation attempt failed. A second attempt was successful in 86% of these patients. The researchers concluded that the study was limited by small sample size, retrospective analysis, failure to compare wireless monitoring with conventional transnasal monitoring, and failure to document the sensitivity and specificity of wireless ph monitoring for detection of GERD. Recent studies (SB des Varannes et al. 2005, D Tseng, et al. 2005, JE Pandolfino, et al. 2005, and YM Bhat et al. 2006) demonstrate that the wireless procedure is successfully performed and produces successful measurement of esophageal acid in a high proportion (90%) of cases. Overall, it is more comfortable than traditional wired monitoring. Measurements correlate fairly closely to wired monitoring after adjusting test thresholds; however, because of the lack of an established gold standard, even when the two devices are discrepant, it cannot be determined which device is correct. Also, different studies have produced different cutoff values for a normal test. More data are needed to establish appropriate diagnostic

3 PAGE: 3 OF: 6 thresholds. No studies establish that wireless monitoring is superior to wired monitoring in reaching a GERD diagnosis or optimally managing a patient. CODES: Number Description Eligibility for reimbursement is based upon the benefits set forth in the member s subscriber contract. CODES MAY NOT BE COVERED UNDER ALL CIRCUMSTANCES. PLEASE READ THE POLICY AND GUIDELINES STATEMENTS CAREFULLY. Codes may not be all inclusive as the AMA and CMS code updates may occur more frequently than policy updates. CPT: Upper gastroesophageal endoscopy HCPCS: Esophagus, gastroesophageal reflux test; with nasal catheter ph electrode(s) placement, recording, analysis and interpretation Esophagus, gastroesophageal reflux test; with mucosal attached telemetry ph electrode placement, recording, analysis and interpretation No specific codes ICD9: Bradycardia Copyright 2015 American Medical Association, Chicago, IL Laryngitis, chronic Asthma without mention of status asthmaticus (code range) Aspiration pneumonia Esophageal reflux Respiratory problems, including apnea, originating in the perinatal period (code range) ICD10: I49.8 Other specified cardiac arrhythmias J37.0 Chronic laryngitis J44.0-J44.9 J45.20-J Chronic obstructive pulmonary disease (code range) Asthma (code ranges) J69.0 Pneumonitis due to inhalation of food and vomit K21.9 Gastro-esophageal reflux disease without esophagitis P22.8-P22.9 P24.30-P24.31 P28.2-P28.89 P84 REFERENCES: Respiratory distress of the newborn (code range) Neonatal aspiration of milk and regurgitated food (code range) Other respiratory conditions originating in the perinatal period (code range) Other problems with newborn R00.1 Bradycardia, unspecified Ahlawat SK, et al. Day-to-day variability in acid reflux patterns using the BRAVO ph monitoring system. J Clin Gastroenterol 2006 Jan;40(1):20-4.

4 PAGE: 4 OF: 6 American Gastroenterological Association. Guidelines for the diagnosis and management of gastroesophageal reflux disease. [ accessed 6/13/14. Ang D, et al. To Bravo or not? A comparison of wireless esophageal ph monitoring and conventional ph catheter to evaluate non-erosive gastroesophageal reflux disease in a multiracial Asian cohort. J Dig Dis 2010 Feb;11(1): Ayazi S, et al. Bravo catheter-free ph monitoring: normal values, concordance, optimal diagnostic thresholds, and accuracy. Clin Gastroenterol Hepatol 2009 Jan;7(1):60-7. Bechtold ML, et al. Bravo (wireless) ambulatory esophageal ph monitoring: how do day 1 and day 2 results compare? World J Gastroenterol 2007 Aug 14;13(130): *Belafsky PC, et al. Wireless ph testing as an adjunct to unsedated transnasal esophagoscopy: the safety and efficacy of transnasal telemetry capsule placement. Otolaryngol Head Neck Surg 2004 Jul;131(1):26-8. Bhat YM, et al. Wireless esophageal ph monitoring: a new technique means new questions. J Clin Gastroenterol 2006 Feb;40(2): BlueCross BlueShield Association. Esophageal ph monitoring. Medical Policy Reference Manual # Jun 11. BlueCross BlueShield Association. Technology Evaluation Center (TEC). Special report: Wireless esophageal ph monitoring May;21(2). *Charbel S, et al. The role of ph monitoring in symptomatic patients on PPI therapy. Am J Gastroenterol 2005;100(2): *Chotiprashidi P, et al. ASGE technology status evaluation report: wireless esophageal ph monitoring system. Gastrointest Endosc 2005 Oct;62(4): *des Varannes SB, et al. Simultaneous recordings of oesophageal acid exposure with conventional ph monitoring and a wireless system (Bravo). Gut 2005 Dec;54(12): *De Vault KR, et al. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. American College of Gastroenterology. Am J Gastroenterol 2005 Jan;100(1): Doma S, et al. Wireless capsules for esophageal ph monitoring: are we placing them correctly? Digestion 2010;82(1):54-9. Domingues GR, et al. Impact of prolonged 48-h wireless capsule esophageal ph monitoring on diagnosis of gastroesophageal reflux disease and evaluation of the relationship between symptoms and reflux episodes. Arq Gastroenterol 2011 Mar;48(1):24-9. Friedman M, et al. Wireless upper esophageal monitoring for laryngopharyngeal reflux (LPR). Otolaryngol Head Neck Surg 2007 Sep;137(3): Gawron AJ, et al. Advances in diagnostic testing for gastroesophageal reflux disease. World J Gastroenterol 2010 Aug 14;16(30): Gillies RS, et al. Oesophageal ph monitoring using the Bravo catheter-free radio capsule. Eur J Gastroenterol Hepatol 2007 Jan;19(1): Grigolon A, et al. Wireless ph monitoring: better tolerability and lower impact on daily habits. Dig Liver Dis 2007 Aug;39(8): Grigolon A, et al. Prolonged wireless ph monitoring: importance of how to analyse oesophgeal acid exposure. Scand J Gastroenterol 2010 May 10.[Epub ahead of print]. Grigolon A, et al. Diagnostic yield of 96-h wireless ph monitoring and usefulness in patients management. Scand J Gastroenterol 2011 May;46(5):

5 PAGE: 5 OF: 6 Hakanson BS, et al. Comparison of wireless 48-h (Bravo) versus traditional ambulatory 24-h esophageal ph monitoring. Scand J Gastroenterol 2009;44(3): Hirano I, et al. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol 2007 Mar;102(3): *Hochman JA, et al. Tolerance and reliability of wireless ph monitoring in children. J Pediatr Gastroenterol Nutr 2005 Oct;41(4): Katz PO, et al. Telemetry capsule for ambulatory ph monitoring: is it time for a change? Am J Gastroenterol 2008 Dec;103(12): Lacy BE, et al. Safety and tolerability of transoral Bravo capsule placement after transnasal manometry using a validated conversion factor. Am J Gastroenterol 2007 Jan;102(1): *Lee YC, et al. Patients with functional heartburn are more likely to report retrosternal discomfort during wireless ph monitoring. Gastrointest Endosc 2005 Dec;62(6): Moraes-Filho JP, et al. Guidelines for the diagnosis and management of gastroesophageal reflux disease: an evidencebased consensus. Arq Gastroenterol 2010 Mar;47(1): North American Society for Pediatric Gastroenterology and Nutrition. Pediatric GE Reflux Clinical Practice Guidelines. [ accessed 6/13/14. *Pandolfino JE, et al. Comparison of Bravotrade mark wireless and Digitrap-pertrade mark catheter-based ph monitoring systems for measuring esophageal acid exposure. Am J Gastroenterol 2005 Jul;100(7): *Pandolfino JE, et al. Acid reflux event detection using Bravo wireless versus the Slimline catheter ph systems: why are the numbers so different? Gut 2005 Dec;54(12): Pandolfino JE, et al. Esophageal-reflux monitoring. Gastrointest Endosc 2009 Apr;69(4):930.e1. *Prakash C, et al. Value of extended recording time with wireless ph monitoring in evaluating gastroesophageal reflux disease. Clin Gastroenterol Hepatol 2005 Apr; 3(4): Prakash C, e al. Endoscopic removal of the wireless ph monitoring capsule in patients with severe discomfort. Gastrointest Endosc 2006 Nov;64(5): Prakash C and Clouse RE. Wireless ph monitoring in patients with non-cardiac chest pain. Am J Gastroenterol 2006 Mar;101(3): *Remes-Troche JM, et al Performance, tolerability and symptoms related to prolonged ph monitoring using the Bravo System in Mexico. Am J Gastroenterol 2005 Nov;100(11) Schneider JH, et al. Ambulatory ph: monitoring with a wireless system. Surg Endosc 2007 Nov;(11): *Tseng D, et al. Forty-eight-hour ph monitoring increases sensitivity in detecting abnormal esophageal acid exposure. J Gastrointest Surg 2005 Nov;9(8): Turner BG, et al. Endoscopic ph monitoring for patients with suspected or refractory gastroesophageal reflux disease. Can J Gastroenterol 2007 Nov;21(11): *Ward EM, et al. Successful oesophageal ph monitoring with a catheter-free system. Aliment Pharmacol Ther 2004 Feb 15;19(4): Wenner J, et al. Wireless esophageal ph monitoring is better tolerated than the catheter-based technique: results from a randomized cross-over trial. Am J Gastroenterol 2007 Feb;102(2): Wenner J, et al. Optimal thresholds and discriminatory power of 48-h wireless esophageal ph monitoring in the diagnosis of GERD. Am J Gastroenterol 2007 Sep;102(9):

6 PAGE: 6 OF: 6 Wireless ph recording immediately above the squamocolumnar junction improves the diagnostic performance of esophageal ph studies. Am J Gastroenterol 2008 Dec;103(12): *Wong WM, 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): KEY WORDS: Wireless, Bravo CMS COVERAGE FOR MEDICARE PRODUCT MEMBERS There is currently a National Coverage Determination (NCD) for 24-hour ambulatory esophageal monitoring. Please refer to the following NCD website for Medicare Members: details.aspx?ncdid=108&ncdver=1&coverageselection=both&articletype=all&policytype=final&s=new+york+- +Upstate&CptHcpcsCode=36514&bc=gAAAABAAAAAA&