When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Haanstra JF, Al-Toma A, Dekker E, et al. Prevalence of small-bowel neoplasia in Lynch syndrome assessed by video capsule endoscopy. Gut. 2015;64(10):1578-1583.
Hartmann D, Schmidt H, Bolz G, et al. A prospective two-center study comparing wireless capsule endoscopy with intraoperative enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2005;61(7):826-32.
Herrerías JM, Caunedo A, Rodríguez-Telléz M, Pellicer F, Herrerías JM Jr. Capsule endoscopy in patients with suspected Crohn's disease and negative endoscopy. Endoscopy. 2003;35(7):564-568.
Herrerias JM, Leighton JA, Costamagna G, et al. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008;67(6):902-9.
Jeon SR, Kim JO, Kim JB, et al. Portal hypertensive enteropathy diagnosed by capsule endoscopy in cirrhotic patients: a nationwide multicenter study. Dig Dis Sci. 2014;59(5):1036-1041.
Kalantzis N, Papanikolaou IS, Giannakoulopoulou E, et al. Capsule endoscopy; the cumulative experience from its use in 193 patients with suspected small bowel disease. Hepatogastroenterology. 2005;52(62):414-9.
Koornstra JJ. Small bowel endoscopy in familial adenomatous polyposis and Lynch syndrome. Best Pract Res Clin Gastroenterol. 2012;26(3):359-68.
Kopylov U, Yung DE, Engel T, et al. Diagnostic yield of capsule endoscopy versus magnetic resonance enterography and small bowel contrast ultrasound in the evaluation of small bowel Crohn's disease: Systematic review and meta-analysis. Dig Liver Dis. 2017;49(8):854-863.
Koulaouzidis A, Rondonotti E, Giannakou A, et al. Diagnostic yield of small-bowel capsule endoscopy in patients with iron-deficiency anemia: a systematic review. Gastrointest Endosc. 2012;76(5):983-92.
Kurien M, Evans KE, Aziz I et al. Capsule endoscopy in adult celiac disease: a potential role in equivocal cases of celiac disease? Gastrointest Endosc. 2013;77(2):227-32.
Lansdorp-Vogelaar I, von Karsa L; International Agency for Research on C. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Introduction. Endoscopy. 2012;44Suppl3:SE15-30.
Leung WK, Ho SS, Suen BY, et al. Capsule endoscopy or angiography in patients with acute overt obscure gastrointestinal bleeding: a prospective randomized study with long-term follow-up. Am J Gastroenterol. 2012;107(9):1370-6.
Lewis BS. Small intestinal bleeding. Gastroenterol Clin North Am. 2000;29(1):67-95.
Lewis BS, Swain P. Capsule endoscopy in the evaluation of patients with suspected small intestinal bleeding: results of a pilot study. Gastrointest Endosc. 2002;56(3):349-53.
Lichtenstein GR, Loftus EV, Isaacs KL et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4).
Lin OS, Schembre DB, Mergener K, et al. Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux. Gastrointest Endos. 2007;65(4):577-583.
Marmo R, Rotondano G, Piscopo R, et al. Capsule endoscopy versus enteroclysis in the detection of small-bowel involvement in Crohn’s disease: a prospective trial. Clin Gastroenterol Hepatol. 2005;3(8):772-76.
Mata A, Llach J, Castells A, et al. A prospective trial comparing wireless capsule endoscopy and barium contrast series for small-bowel surveillance in hereditary GI polyposis syndromes. Gastrointest Endosc. 2005;61(6):721-5.
Mishkin, DS, et al. ASGE Technology Status Evaluation Report: Wireless Capsule Endoscopy. Gastrointest Endosc. 2006;63(4):539-45.
Novitas Solutions, Inc. Local Coverage Determination (LCD).L35089: Wireless Capsule Endoscopys. [Novitas Solutions, Inc. Web site]. 11/21/2019. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35089&ver=30&Keyword=wireless+capsule&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=BC%7cSAD%7cRTC%7cReg&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA&. Accessed January 10, 2020.
Oliva S, Di Nardo G, Hassan C, et al. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study. Endoscopy. 2014;46(6):485-492.
Pennazio M, Santucci R, Rondonotti E, et al. Outcome of patients with obscure gastrointestinal bleeding after capsule endoscopy; report of 100 consecutive cases. Gastroenterology. 2004;126(3):643-53.
Perez-Cuadrado-Robles E. The role of capsule endoscopy in alarm features and non-responsive celiac disease: a European multi-centre study. Dig Endosc.2017 Dec 18. [Epub ahead of print].
Pilz JB, Portmann S, Peter S, et al. Colon capsule endoscopy compared to conventional colonoscopy under routine screening conditions. BMC Gastroenterol. 2010;10:66.
Postgate AJ, Burling D, Gupta A, et al. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008;53(10):2732-8.
Raju GS, Gerson L, Das A, et al. American Gastroenterological Association (AGA) Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology. 2007;133(5):1694-1696.
Raju GS, Gerson L, Das A, et al. American Gastroenterological Association (AGA) Institute technical review on obscure gastrointestinal bleeding. Gastroenterology. 2007;133(5):1697-1717.
Ramirez FC, Akins R, Shaukat M. Screening of Barrett's esophagus with string-capsule endoscopy: a prospective blinded study of 100 consecutive patients using histology as the criterion standard. Gastrointest Endosc. 2008;8(1):25-31.
Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015;148(5):948-957.
Rokkas T, Niv Y. The role of video capsule endoscopy in the diagnosis of celiac disease: a meta-analysis. Eur J Gastroenterol Hepatol. 2012;24(3):303-8.
San Juan-Acosta M, Caunedo-Alvarez A, Arguelles-Arias F, et al. Colon capsule endoscopy is a safe and useful tool to assess disease parameters in patients with ulcerative colitis. Eur J Gastroenterol Hepatol. 2014;26(8):894-901.
Schoofs N, Devičre J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study. Endoscopy. 2006;38(10):971-7.
Spada C, Hassan C, Marmo R, et al. Meta-analysis shows colon capsule endoscopy is effective in detecting colorectal polyps. Clin Gastroenterol Hepatol. 2010;8(6):516-522.
Spada C, Shah SK, Riccioni ME, et al. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007;41(6):576-82.
Sung J, Ho KY, Chiu HM, et al. The use of Pillcam Colon in assessing mucosal inflammation in ulcerative colitis: a multicenter study. Endoscopy. 2012;44(8):754-8.
Urquhart P, Grimpen F, Lim GJ, et al. Capsule endoscopy versus magnetic resonance enterography for the detection of small bowel polyps in Peutz-Jeghers syndrome. Fam Cancer. 2014;13(2):249-255.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary. K053639: Given® AGILE Patency System; premarket approval letter. [FDA Web site]. 05/08/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053639.pdf. Accessed January 4, 2018.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary. K063259: Olympus® Capsule Endoscopy System. [FDA Web site]. 09/14/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063259.pdf. Accessed January 4, 2018.
US Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary. K042960: Given® Diagnostic System with PillCam™ ESO Capsule; premarket approval letter. [FDA Web site]. 11/24/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042960.pdf. Accessed January 4, 2018.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Given PillCam® Platform with PillCam® SB Capsules. Given® AGILE Patency System. 510(k) summary. [FDA Web site]. 9/28/2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090557.pdf. Accessed January 4, 2018.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. MicroCam Capsule Endoscope System. 510K Summary. [FDA Web site]. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111450.pdf. Accessed January 4, 2018.
US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564-2575.
Van Gossum A. Obscure digestive bleeding. Best Pract Res Clin Gastroenterol.
Van Gossum A, Munoz-Navas M, Fernandez-Urien I, et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009;361(3):264-270.
Xue M, Chen X, Shi L, et al. Small-bowel capsule endoscopy in patients with unexplained chronic abdominal pain: a systematic review. Gastrointest Endosc. 2015;81(1):186-93.
Yang L, Chen Y, Zhang B, et al. Increased diagnostic yield of capsule endoscopy in patients with chronic abdominal pain. PLoS One. 2014;9(1):e87396.
Yung DE. Capsule endoscopy, magnetic resonance enterography, and small bowel ultrasound for evaluation of postoperative recurrence in Crohn's disease: systematic review and meta-analysis. Inflamm Bowel Dis. 2017;24(1):93-100.
Zuckerman GR, Prakash C, Askin MP, et al. American Gastroenterological Association technical review on the evaluation and management of occult and obscure gastrointestinal bleeding. Gastroenterology. 2000;118(1):201-221.