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An ingestible pH and pressure-sensing capsule (SmartPill GI Monitoring System) measures pH, pressure, and temperature changes to signify passage of the capsule through portions of the gastrointestinal tract. It is proposed as a means of evaluating gastric emptying for diagnosis of gastroparesis, and colonic transit times for the diagnosis of slow-transit constipation.
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 tract disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic or postsurgical.
Constipation is a chronic disorder involving infrequent bowel movements, sensation of obstruction, and incomplete evacuation. Many medical conditions can cause constipation such as mechanical obstruction, metabolic conditions, myopathies, and neuropathies. Diagnostic testing for constipation can aid in distinguishing between 2 categories of disorders, slow-transit constipation and pelvic floor dysfunction.
Gastric emptying scintigraphy is considered the reference standard for diagnosing gastroparesis. The patient ingests a radionuclide-labeled standard meal, and subsequent imaging is 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.
Standard tests used in the evaluation of constipation include ingestion of radio-opaque markers and colonic transit scintigraphy. In the radio-opaque markers test, small markers are ingested over one or several days, and abdominal radiographs are performed at 4 and/or 7 days. The number of remaining markers correlates with the colonic transit time. In colonic transit scintigraphy, a radio-labeled meal is ingested, followed by scintigraphic imaging at several time intervals. The location of the scintigraphic signals correlates with colonic transit times.
In 2006, an ingestible capsule (SmartPill® GI Monitoring System; Given Imaging) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, for evaluation of 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. For example, an increase of two or more pH units usually indicates gastric emptying, and a subsequent decreaase of one or more pH units usually indicates passage to the ileocecal junction. 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 during its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal tract transit time. In 2009, FDA expanded the use of the SmartPill to determine colonic transit time for the evaluation of chronic constipation and to differentiate between slow- versus normal- transit constipation. When colonic transit time cannot be determined, small and large bowel transit times combined can be used instead. The SmartPill is not for use in pediatric patients.
This differs from esophageal pH monitoring for gastroesophageal reflux disease, which measures pH levels in various ways such as through catheters, impedance, or a temporarily implanted device such as the Bravo™ pH Monitoring System. The ingestible pH and pressure-sensing capsule (ie, SmartPill®) also differs from the wireless capsule endoscopy (ie, PillCam™), which is a swallowed capsule that transmits video images wirelessly.
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 suspected gastroparesis, constipation, or other gastrointestinal motility disorders.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
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.
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.
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.
04/24/2014: Policy reviewed; description updated. Policy statement unchanged.
03/31/2015: Policy reviewed; description and policy statement unchanged. Policy guidelines updated to define investigative.
07/30/2015: Code Reference section updated for ICD-10.
01/07/2016: Policy description updated. Policy statement unchanged.
06/01/2016: Policy number A.2.01.81 added.
12/01/2016: Policy description updated regarding devices. Policy statement unchanged.
Blue Cross Blue Shield Association Policy # 2.01.81
This may not be a comprehensive list of procedure codes applicable to this policy.
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