Ingestible pH and Pressure Capsule Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 08|01|2006 POLICY LAST REVIEWED: 01|07|2026 OVERVIEW An ingestible pH and pressure-sensing capsule (SmartPill® GI Monitoring System) measures pH, pressure, and temperature changes to signify the 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. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is not covered for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is considered not medically necessary for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders as the evidence is insufficient to determine the effects of the technology on health outcomes.
COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable diagnostic test benefits/coverage. BACKGROUND 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 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.
Standard tests used in the evaluation of constipation include ingestion of radioopaque markers and colonic transit scintigraphy. In the radioopaque markers test, small markers are ingested over one or several days and Medical Coverage Policy | Ingestible pH and Pressure Capsule

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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 2 or more pH units usually indicates gastric emptying, and a subsequent decrease of 1 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- vs 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.

For individuals who have suspected disorders of gastric emptying or suspected slow-transit constipation who receive diagnostic testing with an ingestible pH and pressure capsule, the evidence includes studies of test characteristics and case series of patients who have undergone the test. Relevant outcomes are test validity, other performance measures, symptoms, functional outcomes, and health status measures. The available studies have provided some comparative data on the SmartPill ingestible pH plus pressure-sensing capsule and other techniques for measuring gastric emptying. This evidence primarily consists of assessments of concordance with available tests. Because the available tests (eg, gastric emptying scintigraphy) are imperfect criterion standards, it is not possible to determine the true sensitivity and specificity of SmartPill. The results of the concordance studies have revealed a moderate correlation with alternative tests, but have provided only limited additional data on the true accuracy of the test in clinical care. Evaluation of cases with discordant results would be of particular value and, ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes. The evidence to date on the clinical utility of testing is lacking, consisting of a small number of retrospective studies. It is not possible to determine whether there is net improvement in health outcomes using SmartPill vs standard diagnostic tests. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Medicare Advantage Plans and Commercial Products The following CPT code is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 91112 Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule,

         with interpretation and report

RELATED POLICIES Not applicable

PUBLISHED Provider Update, March 2026 Provider Update, April 2025 Provider Update, April 2024 Provider Update, April 2023 Provider Update, October 2022

REFERENCES

1. Abell TL, Camilleri M, Donohoe K, et al. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. Mar 2008; 36(1):44-54. PMID 18287197

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

2. Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. Nov 2004; 127(5):1592-1622. PMID 15521026
3. Tougas G, Eaker EY, Abell TL, et al. Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol. Jun 2000; 95(6):1456-1462. PMID 10894578
4. Stein E, Berger Z, Hutfless S, et al. Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: A Comparative Effectiveness Review. Rockville, MD: Agency for Healthcare Research and Quality; 2013.
5. Green AD, Belkind-Gerson J, Surjanhata BC, et al. Wireless motility capsule test in children with upper gastrointestinal symptoms. J Pediatr. Jun 2013; 162(6):1181-1187. PMID 23290514
6. Kuo B, Maneerattanaporn M, Lee AA, et al. Generalized transit delay on wireless motility capsule testing in patients with clinical suspicion of gastroparesis, small intestinal dysmotility, or slow transit constipation. Dig Dis Sci. Oct 2011; 56(10):2928-2938. PMID 21625964
7. Rao SS, Mysore K, Attaluri A, et al. Diagnostic utility of wireless motility capsule in gastrointestinal dysmotility. J Clin Gastroenterol. Sep 2011; 45(8):684-690. PMID 21135705
8. Rao SS, Camilleri M, Hasler WL, et al. Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies. Neurogastroenterol Motil. Jan 2011; 23(1):8-23. PMID 21138500

9. Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. Jan 2013; 108(1):18-37; quiz 38. PMID 23147521

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