Print

Date Printed: August 18, 2017: 10:33 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-01

Original Effective Date: 08/15/01

Reviewed: 03/23/17

Revised: 04/15/17

Subject: Esophageal pH Monitoring

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Acid reflux is the cause of heartburn, acid regurgitation esophagitis, and Barrett’s esophagus and can be a cause of esophageal stricture, posterior laryngitis, some cases of asthma, chronic cough, chronic hoarseness, dental erosions, 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 pH monitoring is a technique used for diagnosing gastroesophageal reflux disease and the duration of time required for the esophagus to clear the acid. A tube containing a pH (anti-log of hydrogen ion concentration) electrode is passed through the nose and positioned in the esophagus 5 cm above the upper margin of the lower esophageal sphincter (LES). For 24-hour monitoring, the electrode is then connected to a pH meter/recorder that is worn by the patient on a waist belt or shoulder strap. The patient keeps a record of each time reflux symptoms occur. The recorder provides a continuous record (chart) of the pH of the esophagus, which can later be analyzed and correlated with the symptoms recorded by the patient. Esophageal pH monitoring is performed either during esophageal manometry or as a prolonged study in ambulatory patients (24-hour pH monitoring).

A catheter-free, temporarily implanted device (Bravo™ pH Monitoring System, Medtronic) has been cleared for marketing 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.

Several wireless and catheter-based (wired) esophageal pH monitoring devices have been cleared for marketing by FDA through the 510(k) process (e.g., Bravo pH Monitoring System (Given Imaging), the Sandhill Scientific PediaTec™ pH Probe (Sandhill Scientific), TRIP CIC Catheter (Tonometrics)).

POSITION STATEMENT:

Esophageal pH monitoring using a catheter-based system OR wireless system meets the definition of medical necessity for ANY of the following clinical indications in adults and children who are able to report symptoms:

• Documentation of abnormal acid exposure in endoscopy-negative patients being considered for surgical anti-reflux 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 1-month trial of proton pump inhibitor therapy

• Evaluation of suspected otolaryngologic manifestations of gastroesophageal reflux disease (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.

Esophageal pH monitoring (twenty-four hour catheter based) meets the definition of medical necessity for infants or children who are unable to report or describe symptoms of reflux with ANY of the following:

• Unexplained apnea

• Bradycardia

• Refractory coughing or wheezing, stridor, or recurrent choking (aspiration)

• Persistent or recurrent laryngitis

• Recurrent pneumonia.

Catheter based impedance pH monitoring for GERD does not meet the definition of medical necessity. The evidence is insufficient to determine that the technology improves health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe esophageal pH monitoring:

CPT Coding

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

ICD-10 Diagnoses Codes That Support Medical Necessity for 90134 and 90135

G47.30

Sleep apnea, unspecified

I49.8

Other specified cardiac arrhythmias

J02.8

Acute pharyngitis due to other specified organisms

J02.9

Acute pharyngitis, unspecified

J04.0

Acute laryngitis

J31.2

Chronic pharyngitis

J37.0

Chronic laryngitis

J44.0

Chronic obstructive pulmonary disease with acute lower respiratory infection

J44.1

Chronic obstructive pulmonary disease with (acute) exacerbation

J44.9

Chronic obstructive pulmonary disease, unspecified

J45.20

Mild intermittent asthma, uncomplicated

J45.21

Mild intermittent asthma with (acute) exacerbation

J45.22

Mild intermittent asthma, uncomplicated

J45.30

Mild intermittent asthma, uncomplicated

J45.31

Mild persistent asthma with (acute) exacerbation

J45.32

Mild persistent asthma with status asthmaticus

J45.40

Moderate persistent, uncomplicated asthma NOS

J45.41

Moderate persistent with (acute) exacerbation

J45.42

Moderate persistent with status asthmaticus

J45.50

Severe persistent, uncomplicated asthma NOS

J45.51

Severe persistent with (acute) exacerbation

J45.52

Severe persistent with status asthmaticus

J45.901

Unspecified asthma with (acute) exacerbation

J45.902

Unspecified asthma with status asthmaticus

J45.909

Unspecified asthma, uncomplicated

J45.990

Exercise induced bronchospasm

J45.991

Cough variant asthma

J45.998

Other asthma

J69.0

Pneumonitis due to inhalation of food and vomit

K21.9

Gastro-esophageal reflux disease without esophagitis

P22.8

Other respiratory distress of newborn

P22.9

Respiratory distress of newborn, unspecified

P24.30

Neonatal aspiration of milk and regurgitated food without respiratory symptoms

P24.31

Neonatal aspiration of milk and regurgitated food with respiratory symptoms

P28.2

Cyanotic attacks of newborn

P28.3

Primary sleep apnea of newborn

P28.4

Other apnea of newborn

P28.5

Respiratory failure of newborn

P28.81

Respiratory arrest of newborn

P28.89

Other specified respiratory conditions of newborn

P29.12

Neonatal bradycardia

P84

Other problems with newborn

R00.1

Bradycardia, unspecified

R05

Cough

R06.00

Dyspnea NOS

R06.09

Other forms of dyspnea

R06.1

Stridor

R06.2

Wheezing

R06.5

Mouth breathing

R06.7

Sneezing

R06.81

Apnea, not elsewhere classified

R06.89

Other abnormalities of breathing

R19.6

Halitosis

REIMBURSEMENT INFORMATION:

Esophageal manometry, when used for pH tip placement, is considered incidental to the pH recording. There is no specific procedure code for reporting esophageal manometry.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

The following National Coverage Determinations (NCDs) was reviewed on the last guideline reviewed date: 24-Hour Ambulatory Esophageal pH Monitoring, (100.3) located at cms.gov.

DEFINITIONS:

Anti-reflux surgery: surgical procedure of the esophagus and stomach in an attempt to stop or decrease secretions from backing up into the esophagus.

Barrett’s esophagus: metaplasia of the lower esophagus that is characterized by replacement of squamous epithelium with columnar epithelium, occurs especially as a result of chronic gastroesophageal reflux, and is associated with an increased risk for esophageal carcinoma – called also Barrett's epithelium.

Dyspepsia: heartburn.

Dysphagia: difficulty swallowing.

Esophageal manometry: determines the pressure in the upper and lower esophageal sphincters and the effectiveness and coordination of propulsive movements and detects abnormal contractions. It is used to diagnose achalasia, diffuse spasm, scleroderma, and lower esophageal sphincter hypo – and hypertension and to evaluate esophageal function for certain therapeutic procedures (e.g., anti-reflux surgery, pneumatic dilation for achalasia). It is performed by passing a small tube past the throat and into the esophagus. Complications are extremely uncommon but may include trauma to the nasal passages.

Nissen fundoplasty: type of surgical procedure for treating reflux.

Post-cibal: after eating.

Stridor: wheezing heard in the neck area upon inhalation and exhalation.

RELATED GUIDELINES:

Ingestible pH and Pressure Capsule, 01-91000-08

Wireless Capsule Endoscopy, 01-91000-05

OTHER:

Other names used to report esophageal pH monitoring:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Acid reflux test
Catheter based impedance pH monitoring
Esophageal pH monitoring
Esophageal pH recording
Esophagus acid reflux test
Gastroesophageal reflux testing
ORION II Ambulatory pH Recorder (Medical Measurement Systems (MMS))

REFERENCES:

  1. American Gastroenterological Association medical position statement: Guidelines on the use of esophageal pH recording. Gastroenterology 1996; 110(6):1981.
  2. American Gastroenterological Society (AGA): American Gastroenterological Association medical position statement: Clinical use of esophageal manometry. Gastroenterology 2005; 128:207-208.
  3. Belafsky PC, Allen K, Castro-Del Rosario L, Roseman D. Wireless pH testing as an adjunct to unsedated transnasal esophagoscopy: the safety and efficacy of transnasal telemetry capsule placement. Otolaryngol Head Neck Surg. 2004; 131(1): 26-8.
  4. Blue Cross Blue Shield Association TEC. Wireless Esophageal pH Monitoring. TEC Special Report 2006.
  5. Blue Cross Blue Shield Association Medical Policy Esophageal pH Monitoring 2.01.20, 11/16.
  6. British Society of Gastroenterology (BSG). Guidelines for oesophageal manometry and pH monitoring. Clinical Practice Guidelines. London, UK: BSG; 1996.
  7. Bruley des Varannes S, Mion F, Ducrotte P, Zerbib F, Denis P, Ponchon T, Thibault R, Galmiche JP. Simultaneous recordings of oesophageal acid exposure with conventional pH monitoring and a wireless system (Bravo(R)). Gut. 2005 Apr 20.
  8. Centers for Medicare and Medicaid Services (CMS) Manual System NCD for 24-Hour Ambulatory Esophageal pH Monitoring (100.3), 06/11/85.
  9. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 2, Section 100.3 24-Hour Ambulatory Esophageal pH Monitoring, (06/11/05).
  10. Chotiprashidi P, Liu J, Carpenter S, Chuttani R, DiSario J, Hussain N, Somogyi L, Petersen BT; Technology Assessment Committee, American Society for Gastrointestinal Endoscopy. ASGE Technology Status Evaluation Report: wireless esophageal pH monitoring system. Gastrointest Endosc. 2005 Oct; 62(4): 485-7.
  11. DeVault KR, Castell DO; American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005 ; 100(1): 190-200.
  12. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of Gastroesophageal reflux disease. American Journal of Gastroenterology 2013; 108:308-328.
  13. National Guideline Clearinghouse (NGC). Guideline synthesis: Diagnosis and treatment of gastroesophageal reflux disease (GERD). In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2008 May (revised 2016 Feb).
  14. National Guideline Clearinghouse (NGC). Guideline summary: Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2015 Jan 14.
  15. National Institute for Clinical Excellence (NICE). Interventional procedures overview of catheterless oesophageal pH monitoring [ipg187]. London, UK: NICE; January 2006.
  16. Pandolfino JE, Richter JE, Ours T, Guardino JM, Chapman J, Kahrilas PJ. Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol. 2003; 98(4): 740-9.
  17. Pandolfino JE, Schreiner MA, Lee TJ, Zhang Q, Boniquit C, Kahrilas PJ. Comparison of the Bravo™ Wireless and Digitrapper™ Catheter-Based pH Monitoring Systems for Measuring Esophageal Acid Exposure. Am J Gastroenterol. 2005; 100 (7): 1466-76.
  18. Tutuian R, Castell DO. Esophageal pH monitoring: wireless does not mean worry less. J Clin Gastroenterol. 2006 Feb; 40(2): 91-2.
  19. Ward EM, Devault KR, Bouras EP, Stark ME, Wolfsen HC, Davis DM, Nedrow SI, Achem SR. Successful oesophageal pH monitoring with a catheter-free system. Aliment Pharmacol Ther. 2004 ; 19(4): 49-54.
  20. Wong WM, Bautista J, Dekel R, Malagon IB, Tuchinsky I, Green C, Dickman R, Esquivel R, Fass R. Feasibility and tolerability of transnasal/per-oral placement of the wireless pH capsule vs. traditional 24-h esophageal pH monitoring-a randomized trial. Aliment Pharmacol Ther. 2005 ; 21(2): 155-63.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/23/17.

GUIDELINE UPDATE INFORMATION:

08/15/01

Medical Coverage Guideline Revised and Reformatted.

10/15/03

Reviewed; added information regarding 48-hour catheter-free capsule pH monitoring systems (investigational)

01/01/05

Annual HCPCS coding update; consisting of deletion of CPT codes 91032 and 91033 and addition of CPT codes 91034, 91035, 91037 and 91038.

10/15/05

Scheduled review and revision of guideline; consisting of updated references.

08/15/06

Review and revision of guideline consisting of updated references.

07/15/07

Annual review; current coverage and limitations maintained, reformatted guideline, references updated.

07/15/08

Review and revision of guideline consisting of updated references.

06/15/10

Annual review. Updated ICD-9 diagnosis codes; revised descriptor (427.89, 476.0, 780.57, 784.9, 786.09, and 786.2), added 4th digit (493.00 – 493.92), and added diagnosis codes: 779.81, 786.03, and 786.07. Deleted related Internet links. Updated references.

01/15/11

Revision; related ICD-10 codes added.

05/11/14

Revision: Program Exceptions section updated.

10/01/15

Revision; updated ICD9 and ICD10 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

04/15/17

Added catheter based impedance pH monitoring for GERD and deleted esophageal pH recording to detect or verify reflux esophagitis.

Date Printed: August 18, 2017: 10:33 AM