Esophageal pH Monitoring

POLICY NUMBER

A.2.01.20

DESCRIPTION

Esophageal pH monitoring, using wired or wireless devices, can record the pH of the lower esophagus for a period of several days. Impedance pH monitoring measures electrical impedance in the esophagus to evaluate reflux episodes concurrent with changes in pH. These tests are used for certain clinical indications in the evaluation of gastroesophageal reflux disease (GERD).

Gastroesophageal Reflux Disease

Acid reflux is the cause of heartburn and acid regurgitation esophagitis, which can lead to esophageal stricture. Acid reflux can also cause or contribute to some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia.

Diagnosis

Gastroesophageal reflux disease is most commonly diagnosed by clinical evaluation and treated empirically with a trial of medical management. For patients who do not respond appropriately to medications, or who have recurrent chronic symptoms, endoscopy is indicated to confirm the diagnosis and assess the severity of reflux esophagitis. In some patients, endoscopy is nondiagnostic, or results are discordant with the clinical evaluation (in these cases, further diagnostic testing may be of benefit).

Monitoring

Esophageal monitoring is done using a tube with a pH electrode attached to its tip, which is then passed into the esophagus to approximately 5 cm above the upper margin of the lower esophageal sphincter. The electrode is attached to a data recorder worn on a waist belt or shoulder strap. Every instance of acid reflux, as well as its duration and pH, is recorded over a 24-hour period. Wireless pH monitoring is achieved using endoscopic or manometric guidance to attach the pH measuring capsule to the esophageal mucosa using a clip. The capsule records pH levels for up to 96 hours and transmits them via radiofrequency telemetry to a receiver worn on the patient’s belt. Data from the recorder are uploaded to a computer for analysis by a nurse or doctor.

Another technology closely related to pH monitoring is impedance pH monitoring, which incorporates pH monitoring with measurements 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 can identify reflux events in which the liquid is only slightly acidic or non-acidic.

Esophageal pH electrodes are considered Class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements.

Several wireless and catheter-based (wired) esophageal pH monitoring devices have been cleared for marketing by the FDA through the 510(k) process. Examples include the Bravo™ pH Monitoring System (Medtronic), the Sandhill Scientific PediaTec™ pH Probe (Sandhill Scientific), the ORION II Ambulatory pH Recorder (MMS, Medical Measurement Systems), and the TRIP CIC Catheter (Tonometrics). FDA product code: FFT. The ZepHr® Reflux Monitoring System (Diversatek) is an impedance device to detect reflux. FDA product code: FFX.

POLICY

Esophageal pH monitoring using a catheter or wireless-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 individuals being considered for surgical antireflux repair;

• Evaluation of individuals after antireflux surgery who are suspected of having ongoing abnormal reflux;

• Evaluation of individuals with either normal or equivocal endoscopic findings and reflux symptoms refractory to proton pump inhibitor therapy;

• Evaluation of refractory reflux in individuals 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(i.e., laryngitis, pharyngitis, chronic cough) in individuals who have failed to respond to atleast 4 weeks of proton pump inhibitor therapy;

• Evaluation of concomitant gastroesophageal reflux disease in individuals with adult-onset, nonallergic asthma 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:

24-hour catheter-based impedance pH monitoring may be considered investigational in individuals with established gastroesophageal reflux disease (GERD) on proton pump inhibitor (PPI) therapy, whose symptoms have not responded adequately to twice-daily PPI therapy, in order to define refractory GERD.

*Esophageal pH monitoring systems should be used in accordance with U.S. FDA-approved indications and age ranges.

POLICY EXCEPTIONS

For the Federal Employee Program (FEP) subscribers only, devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The endoscopy performed for placing the BRAVO capsule is not reimbursed separately. (added 11/2003)

Manometry, when used for pH tip placement, should be considered part of the pH recording.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

9/1993: Approved by Medical Policy Advisory Committee (MPAC)

5/2000: Comprehensive revision approved by MPAC

4/26/2002: Type of Service and Place of Service deleted

11/2003: Reviewed by MPAC, no changes in coverage criteria, BRAVO^TM pH Monitoring System covered at current reimbursement guidelines, "Description" section revised to be consistent with BCBSA, FEP exception added

2/13/2004: Code Reference section updated

3/22/2005: Code Reference section updated, CPT code 91032 deletion date of 12/31/2004 and Note "See CPT code 91034-91035" added, CPT code 91033 description revised, deletion date of 12/31/2004, and Note "See CPT code 91034-91035" added, CPT code 91034, 91035 with effective date of 1/1/2005 added

8/18/2006: Policy section re-written for clarity and 48-hour wireless monitoring changed from investigational to not medically necessary.

12/19/2007: 91035 moved to non-covered table.

1/10/2008: Policy reviewed, no changes

9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied

12/17/2008: Policy reviewed, no changes

9/29/2009: Code Reference section updated. New ICD-9 diagnosis codes 784.42, 784.43 and 784.44 added to covered table. Description revised for ICD-9 code 784.49.

06/03/2010: Policy statement updated to indicate that wireless monitoring may be considered medically necessary in patients who meet criteria for testing but cannot tolerate catheter-based testing. Wireless monitoring in all other situations is considered not medically necessary. The time interval in the policy statement for wireless monitoring was changed from “48-hour” to “48- to 96-hour.” Other policy statements unchanged. Deleted outdated references from the Sources section. Due to the policy statement change, CPT code 91035 was moved from non-covered to covered.

01/24/2011: Added ICD-9 code 530.81 to the Covered Codes table.

06/22/2011: Policy description updated to add information regarding impedance-pH monitoring. Added the following policy statement: 24-hour catheter-based impedance-pH monitoring is considered not medically necessary.

07/12/2012: Added wireless pH monitoring to the first medically necessary policy statement. Deleted the following policy statement: 1) 48- to 96-hour, catheter-free, wireless esophageal monitoring may be considered medically necessary for use in esophageal pH monitoring for patients who are unable to tolerate catheter-based testing (and unable to complete this testing) but meet the criteria listed above for monitoring. 2) 48- to 96-hour, catheter-free, wireless esophageal monitoring is considered not medically necessary for the use in esophageal pH monitoring, except under the specific circumstances noted. Added monitoring must be done in accordance with FDA approved indications and age ranges to policy statement. Added the following ICD-9 codes to the Covered Codes table: 427.89, 476.0,507.0, 770.81-770.89, 780.57, 784.99, 786.03, 786.07, and 786.1. Added a Non-Covered Codes table and added 91037 and 91038 as non-covered procedures as these codes are used to report impedance-pH monitoring.

10/17/2013: Removed “24-hour” from the policy statement on impedance monitoring as catheter-based impedance monitoring for any length of time is considered not medically necessary.

08/01/2014: Policy reviewed; description updated. Policy statement unchanged.

08/26/2015: Medical policy revised to add ICD-10 codes.

11/06/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

06/01/2016: Policy number A.2.01.20 added.

12/01/2016: Policy description updated regarding impedance pH monitoring. Medically necessary policy statement criteria updated to change "systems" to "symptoms." Policy Guidelines updated regarding use of manometry.

01/04/2018: Policy description updated. Policy statements unchanged.

12/27/2018: Policy reviewed; no changes.

12/06/2019: Policy reviewed; no changes.

09/28/2020: Code Reference section updated to add new ICD-10 diagnosis codes K20.80, K20.81, K20.90, K20.91, K21.00, and K21.01, effective 10/01/2020.

12/31/2020: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

10/01/2021: Code Reference section updated to add new ICD-10 diagnosis codes R05.1, R05.2, R05.3, R05.8, and R05.9 effective 10/01/2021.

01/26/2022: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis codes K20.8, K20.9, and K21.0.

09/30/2022: Code Reference section updated to add new ICD-10 diagnosis codes P28.30, P28.31, P28.32, P28.33, P28.39, P28.40, P28.41, P28.42, P28.43, and P28.49, effective 10/01/2022.

03/09/2023: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals." Not medically necessary policy statement revised and changed to investigational. Code Reference section updated to remove deleted ICD-10 diagnosis code R05.

12/11/2023: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis codes P28.3 and P28.4.

01/28/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.20 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes 

Not Medically Necessary Codes

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