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Esophageal pH monitoring using wired or wireless devices can record the pH of the lower esophagus for a period of one to several days. These devices may aid in the diagnosis of gastroesophageal reflux disease (GERD) in patients who have an uncertain diagnosis after clinical evaluation and endoscopy.
Acid reflux is the cause of heartburn and acid regurgitation esophagitis, which can lead to esophageal stricture. Acid reflux may also be the cause or a contributing factor in some cases of asthma, posterior laryngitis, chronic cough, dental erosions, chronic hoarseness, pharyngitis, subglottic stenosis or stricture, nocturnal choking, and recurrent pneumonia.
GERD 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.
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. 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, indicating gastric acid reflux over a 24-hour period. Using endoscopic or manometric guidance, the capsule is temporarily implanted in 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 in 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 is able to identify reflux events in which the liquid is only slightly acidic or non-acidic.
Esophageal pH electrodes are U.S. Food and Drug Administration (FDA) 510(k) exempt Class I devices. A catheter-free, temporarily implanted device (BravoTM pH Monitoring System, Medtronic) has been cleared for marketing by the FDA 510(k) process for the purpose of “gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.”
A number of wireless and catheter-based (wired) esophageal pH monitoring devices have been cleared through the 510(k) process. Some examples are the Bravo pH Monitoring System (Given Imaging), the Sandhill Scientific PediaTec™ pH Probe (Sandhill Scientific), the ORION II Ambulatory pH Recorder (MMS, Medical Measurement Systems) and the TRIP CIC Catheter (Tonometrics).
POLICYEsophageal pH monitoring using a wireless or catheter-based system may be considered medically necessary for the following clinical indications in adults and children or adolescents able to report symptoms*:
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:
Catheter-based impedance-pH monitoring is considered not medically necessary.
*Esophageal pH monitoring systems should be used in accordance with FDA-approved indications and age ranges.
POLICY EXCEPTIONSFor 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.
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)
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 Nervous/Mental Conditions, 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 Medically Necessary, “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 HISTORY9/1993: 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, BRAVOTM 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.20
CODE REFERENCEThis 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.
Not Medically Necessary Codes
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