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DESCRIPTIONAn 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.
POLICYMeasurement 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 EXCEPTIONSFederal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY10/13/2009: 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.
10/30/2013: Policy reviewed; policy statement unchanged. Added CPT code 91112 to the Code Reference section. Removed unlisted code 91299 and deleted code 0242T from the Code Reference section.
SOURCESBlue Cross Blue Shield Association Policy # 2.01.81
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.