DESCRIPTION
An ingestible pH and pressure-sensing capsule (e.g., SmartPillŪ GI Monitoring System) has been developed as a means of evaluating 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 the pH and pressure-sensing capsule does not measure 50% emptying time, it can be correlated with the scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature throughout its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal transit time. These other functions do not assess delayed gastric emptying, and are not evaluated in this policy.
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 post-surgical. 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 postprandial 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. Currently protocol and parameters are yet to be standardized for the gastric emptying scintigraphy.
POLICY
Measurement obtained via ingestible pH and pressure capsule for evaluations of conditions including but not limited to the following is considered investigational:
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Current literature does not determine the health outcome or efficacy and safety of using the pH pressure sensing capsule for the diagnosis of gastroparesis. Larger studies are needed that compare the results of the current conventional standard test for gastroparesis with those of the ingestible pH and pressure capsule.
SOURCES
Abell, T. L., Camilleri, M., Donohoe, K., Hasler, W. L., Lin, H. C., Maurer, A. H., et al. (2008). Consensus recommendations for gastric emptying scintigraphy: A joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Journal of Nuclear Medicine Technology, 36 (1), 44-54.
American Gastroenterological Association. (2004). American Gastroenterological Association medical position statement: Diagnosis and treatment of gastroparesis. Retrieved August 16, 2011 from http://www.gastrojournal.org/article/S0016-5085(04)01633-6/fulltext.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2011). Ingestible pH and pressure capsule. (2.01.81). Retrieved August 15, 2011 from BlueWeb. (8 articles and/or guidelines reviewed)
Camilleri, M. (2007). Clinical practice. Diabetic gastroparesis. The New England Journal of Medicine, 356 (8), 820-829.
Camilleri, M., Thorne, N. K., Ringel, Y., Hasler, W. L., Kuo, B., Esfandyari, T., et al. (2010). Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterology and Motility, 22 (8), 874-882. (Level 2 Evidence - Industry sponsored)
Cassilly, D., Kantor, S., Knight, L. C., Maurer, A. H., Fisher, R. S., Semler, J., et al. (2008). Gastric emptying of a non-digestible solid: Assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterology and Motility, 20 (4), 311-319. (Level 4 Evidence - Industry sponsored)
Donohoe, K., Maurer, A., Ziessman, H., Urbain, J., Royal, H., & Martin-Comin, J. (2009). Procedure guideline for adult solid-meal gastric-emptying study 3.0. Journal of Nuclear Medical Technology, 37 (3), 196-200.
Friedenberg, F. K. & Parkman, H. P. (2008). Persistent nausea and abdominal pain in a patient with delayed gastric emptying. Clinical Gastroenterology and Hepatology, 6 (12), 1309-1314.
Hasler, W. (2007). Gastroparesis: Symptoms, evaluation, and treatment. Gastroenterology Clinic of North America, 36 (3), 619-647.
Hasler, W. L. (2008). Gastroparesis - Current concepts and considerations. Medscape Journal of Medicine, 10 (1), 1-16.
Hasler, W. L. (2011). Gastroparesis: Pathogenesis, diagnosis and management. Nature reviews. Gastroenterology & Hepatology, 8 (8), 438-453.
Hasler, W. L., Coleski, R., Chey, W. D., Koch, K. L., McCallum, R. W., Wo, J. M., et al. (2008). Differences in intragastric pH in diabetic vs. idiopathic gastroparesis: Relation to degree of gastric retention. American Journal of Physiology. Gastrointestinal and Liver Physiology, 294 (6), G1384-G1391. (Level 2 Evidence - Industry sponsored)
Hasler, W. L., Saad, R. J., Rao, S. S., Wilding, G. E., Parkman, H. P., Koch, K. L., et al. (2009). Heightened colon motor activity measured by a wireless capsule in patients with constipation: Relation to colon transit and IBS. American Journal of Physiology. Gastrointestinal and Liver Physiology, 297 (6), G1107-G1114. (Level 3 Evidence - Industry sponsored)
Hyett, B., Martinez, F. J., Gill, B. M., Mehra, S., Lembo, A., Kelly, C. P., et al. (2009). Delayed radionucleotide gastric emptying studies predict morbidity in diabetics with symptoms of gastroparesis. Gastroenterology, 137 (2), 445-452. (Level 4 Evidence - Independent study)
Kloetzer, L., Chey, W. D., McCallum, R. W., Koch, K. L., Wo, J. M., Sitrin, M., et al. (2010). Motility of the antroduodenum in healthy and gastroparetics characterized by wireless motility capsule. Neurogastroenterology and Motility, 22 (5), 527-533. (Level 2 Evidence - Industry sponsored)
Kuo, B., McCallum, R., Koch, K., Sitrin, M., Wo, J., Chey, W., et al. (2008). Comparison of gastric emptying of a non digestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Ailment Pharmacology Therapy, 27 (2), 186-196. (Level 3 Evidence - Industry sponsored)
Magbool, S., Parkman, H. P., & Friedenberg, F. K. (2009). Wireless capsule motility: Comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit. Digestive Diseases and Sciences, 54 (10), 2167-2174. (Level 4 Evidence - Industry sponsored)
Rao, S. S., Camilleri, M., Hasler, W. L., Maurer, A. H., Parkman, H. P., Saad, R., et al. Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies. Neurogastroenterology and Motility, 23 (1), 8-23.
Rao, S. S., Kuo, B., McCallum, R. W., Chey, W. D., Dibaise, J. K., Hasler, W. L., et al. (2009). Investigation of colonic and whole gut transit with wireless motility capsule and radioopaque markers in constipation. Clinical Gastroenterology and Hepatology, 7 (5), 537-544. (Level 2 Evidence - Industry sponsored)
Rao, S. S., Mysore, K., Attaluri, A., & Valestin, J. (2011). Diagnostic utility of wireless motility capsule in gastrointestinal dysmotility. Journal of Clinical Gastroenterology, 45 (8), 684-690. (Level 2 Evidence - Industry sponsored)
Rao, S.S. (2007). Constipation: Evaluation and treatment of colonic and anorectal motility disorders. Gastroenterology Clinics of North America, 36 (3), 687-711.
Sarosiek, L., Selover, K. H., Katz, L. A., Semler, J. R., Wilding, G. E., Lackner, J. M., et al. (2010). The assessment of regional gut transit times in healthy controls and patients with gastroparesis using wireless motility technology. Alimentary Pharmacology and Therapeutics, 31 (2), 313-322. (Level 3 Evidence - Industry sponsored)
U.S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053547. Retrieved September 23, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053547.pdf.
U.S. Food and Drug Administration. (2009, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092342. Retrieved August 16, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092342.pdf.
ORIGINAL EFFECTIVE DATE: 3/11/2010
MOST RECENT REVIEW DATE: 9/22/2011
ID_BA
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