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Printer Friendly Version Ingestible pH and Pressure Capsule

Ingestible pH and Pressure Capsule

 

DESCRIPTION

 An ingestible pH and pressure-sensing capsule (SmartPill® GI Monitoring System) is proposed as a means of evaluating gastric emptying.

Gastroparesis is a chronic disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis are often nonspecific and may mimic other gastrointestinal disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic or postsurgical.

The test considered the reference standard for gastroparesis is called gastric emptying scintigraphy. The patient ingests a radionuclide-labeled standard meal, and then images are performed at 0, 1, 2, and 4 hours postprandially to measure how much of the meal has passed beyond the stomach. A typical threshold to indicate abnormal gastric emptying is more than 10% of the meal remaining at 4 hours after ingestion.

An ingestible capsule (SmartPill® GI Monitoring System) has been cleared for marketing by the U.S. Food and Drug Administration (FDA) via a 510(k) application, with the indication for use to evaluate delayed gastric emptying. Gastric emptying is signaled when the pH monitor in the capsule indicates a change in pH from the acidic environment of the stomach to the alkaline environment of the small intestine. While SmartPill does not measure 50% emptying time, it can be correlated with scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature throughout its transit through the entire gastrointestinal (GI) tract, allowing calculations of total GI transit time. These other functions do not assess delayed gastric emptying, and thus are not evaluated in relation to the approved indication. 

 

POLICY

Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is considered investigational for the evaluation of of suspected gastroparesis, constipation, or other gastrointestinal motility disorders.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics 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.

 

POLICY HISTORY

10/13/2009: Policy added

11/19/2009: Approved by MPAC

04/18/2011: Policy reviewed; no changes.

04/12/2012:  Policy statement revised to state that measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is considered investigational for the evaluation of of suspected gastroparesis, constipation, or other gastrointestinal motility disorders. It previously stated that measurement of gastric emptying using an ingestible pH and pressure capsule is considered investigational for the indication of suspected gastroparesis. Added CPT code 0242T to the Code Reference section.

 

SOURCES

Blue Cross Blue Shield Association Policy # 2.01.81 

 

CODE REFERENCE

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes   

Code Number

Description

CPT

91299

Unlisted diagnostic gastroenterology procedure

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

Investigational for all applicable codes

HCPCS

0242T 

Gastrointestinal tract transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report (Added 04-12-2012) 

 

 

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