Print

Date Printed: June 26, 2017: 11:31 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-05

Original Effective Date: 11/15/02

Reviewed: 09/24/15

Revised: 11/01/15

Subject: Wireless Capsule Endoscopy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Wireless capsule endoscopy is a device intended to visualize portions of the bowel which are not accessible via upper or lower endoscopy, primarily the small bowel. Patients swallow the capsule, and it records images of the intestinal mucosa as it passes through the gastrointestinal (GI) tract. The capsule is collected after being excreted and the images interpreted.

Several systems, devices, and components for gastrointestinal imaging have received U.S. Food and Drug Administration (FDA) 510(k) clearance (e.g., Given® Diagnostic Imaging System, Given® Diagnostic System with the PillCam™ ESO, Given® AGILE Patency System, Olympus Capsule Endoscope System, and PillCam®COLON 2 Capsule Endoscopy System).

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Wireless Capsule Endoscopy - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Wireless capsule endoscopy meets the definition of medical necessity for any of the following indications:

Wireless capsule endoscopy is considered experimental or investigational for all other indications including, but not limited to the following, as there is insufficient clinical evidence in the peer-reviewed medical literature that wireless capsule endoscopy improves health outcomes.

The patency capsule (e.g., Given® AGILE Patency System) is considered experimental or investigational, for all indications, including use to evaluate patency of the gastrointestinal tract prior to wireless capsule endoscopy. There is insufficient evidence in the peer-reviewed medical literature to support safety, efficacy, and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

91110

Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus through ileum, with interpretation and report

91111

Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), esophagus with interpretation and report (investigational)

0355T

Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon with interpretation and report (investigational)

NOTE: 91110 have both a technical and a professional component. 91110 include provision of the capsule, hook-up and recording equipment, downloading of the digital data with processing of the video images, and physician review and interpretation with report.

ICD-10 Diagnoses Codes That Support Medical Necessity for 91110: (Effective 10/01/15)

D13.2

Benign neoplasm of duodenum

D13.30

Benign neoplasm of unspecified part of small intestine

D13.39

Benign neoplasm of other parts of small intestine

K50.00

Crohn’s disease of small intestine without complications

K50.011 – K50.019

Crohn’s disease of small intestine with complications

K50.80

Crohn's disease of both small and large intestine without complications

K50.811 – K50.819

Crohn’s disease of both small and large intestine with complications

K50.90

Crohn's disease, unspecified, without complications

K50.911 – K50.919

Crohn’s disease, unspecified, with complications

K55.21

Angiodysplasia of colon with hemorrhage

K57.01

Diverticulitis of small intestine with perforation and abscess with bleeding

K57.11

Diverticulosis of small intestine without perforation or abscess with bleeding

K57.13

Diverticulitis of small intestine without perforation or abscess with bleeding

K57.41

Diverticulitis of both small and large intestine with perforation and abscess with bleeding

K57.51

Diverticulosis of both small and large intestine without perforation or abscess with bleeding

K57.53

Diverticulitis of both small and large intestine without perforation or abscess with bleeding

K92.0

Hematemesis

K92.1

Melena

K92.2

Gastrointestinal hemorrhage, unspecified

Q85.8

Other phakomatoses, not elsewhere classified

Q85.9

Phakomatosis, unspecified

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Wireless Capsule Endoscopy, (L29310) located at fcso.com.

DEFINITIONS:

Angiodysplasia: small abnormalities of blood or lymphatic vessels.

Celiac sprue: chronic hereditary intestinal disorder in which an inability to absorb the gliadin portion of gluten results in the gliadin triggering an immune response that damages the intestinal mucosa.

Enteritis: inflammation of the intestine, especially of the small intestine.

Familial adenomatous polyposis: a disease of the large intestine that is marked by the formation especially in the colon and rectum of numerous adenomatous polyps which typically become malignant if left untreated, that may be either asymptomatic or accompanied by diarrhea or bleeding, and that is inherited as an autosomal dominant trait – abbreviation FAP.

Lynch syndrome: often called hereditary nonpolyposis colorectal cancer (HNPCC), is an inherited disorder that increases the risk of many types of cancer, particularly cancers of the colon (large intestine) and rectum, which are collectively referred to as colorectal cancer.

Obscure GI bleeding: recurrent or persistent iron-deficiency anemia, positive fecal occult blood test, or visible bleeding with no bleeding source found at original endoscopy.

Peutz-Jeghers syndrome: familial polyposis inherited as an autosomal dominant trait and characterized by numerous polyps in the stomach, small intestine, and colon and by melanin-containing spots on the skin and mucous membranes especially of the lips and gums.

Portal hypertensive enteropathy: a condition that describes the pathologic changes and mucosal abnormalities observed in the small intestine of individuals with portal hypertension.

RELATED GUIDELINES:

Esophageal pH Monitoring, 01-91000-01
Ingestible pH and Pressure Capsule, 01-91000-08

OTHER:

Other names used to report Wireless Capsule Endoscopy:

Capsule Endoscopy
Given Capsule Endoscopy
Ingestible Telemetric Video Endoscopy System
Ingestible Telemetric Video Diagnostic Imaging System
Video Capsule Endoscopy (VCE)
Wireless Motility Capsule (WMC)

REFERENCES:

  1. American Society for Gastrointestinal Endoscopy Guidelines: Technology Status Evaluation Report; Wireless Capsule Endoscopy, (08/02).
  2. Apostolopoulos P, Liatsos C, Gralnek IM et al. The role of wireless capsule endoscopy in investigating unexplained iron deficiency anemia after negative endoscopic evaluation of the upper and lower gastrointestinal tract. Endoscopy 2006; 38(11): 1127-1132.
  3. Blue Cross Blue Shield Association Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus and Colon Medical Policy 6.01.33, 09/14.
  4. Blue Cross Blue Shield Association TEC Assessment Wireless Capsule Endoscopy in Obscure Digestive Tract Bleeding, Vol. 16, No. 18, 04/02.
  5. ECRI. Emerging Technology (TARGET) Evidence Report. Capsule endoscopy for diagnosis of obscure small-bowel bleeding. Plymouth Meeting, PA: ECRI. Feb 2008.
  6. ECRI. Health Technology Assessment Information Service. Windows on Medical Technology™. Capsule Endoscopy to Determine the Cause of Bleeding Suspected to Be of Small Bowel Origin. December 2006. Issue No. 143.
  7. ECRI. Target Database. Target Report 888. Capsule endoscopy of the esophagus. Plymouth Meeting, PA: ECRI. December 2007.
  8. Eisen GM, Eliakim R, Zaman A, Schwartz J, Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K, deFranchis R. The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endoscopy. 2006; (1): 31-5.
  9. Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005; (7): 572-8.
  10. Eliakim R, Yassin K, Shlomi I, Suissa A, Eisen GM. A novel diagnostic tool for detecting oesophageal pathology: the PillCam oesophageal video capsule. Aliment Pharmacol Ther. 2004 ; 20(10): 1083-9.
  11. First Coast Service Options, Inc. Wireless Capsule Endoscopy LCD L29310, 01/01/13.
  12. Giardiello FM, Allen JI, Axilbund JE et al. Guidelines on Genetic Evaluation and Management of Lynch Syndrome: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. American Journal of Gastroenterology 2014; 109(8): 1159-1179.
  13. Goldfarb NI, Pizzi LT, Fuhr JP, Salvador C, Sikirica V, Kornbluth A, Lewis Blair. Diagnosing Crohn’s Disease: An Economic Analysis Comparing Wireless Capsule Endoscopy with Traditional Diagnostic Procedures. Dis Manag. 2004 Winter; 7(4): 292-304.
  14. Hanauer SB,, Sandborn W, and The Practice Parameters Committee of the American College of Gastroenterology. Management of crohn’s disease in adults. American Journal of Gastroenterology 2001; 96(3): 635-643.
  15. Hartmann D, Schmidt H; Bolz G, Schilling D, Kinzel F, Eickhoff A, Huschner W, Moller K, Jakobs R, Reitzig P, Weickert U; Gellert K, Schultz H, Guenther K, Hollerbuhl H, Schoenleben K, Schulz HJ, Riemann JF. 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.
  16. Hayes, Inc. Hayes Medical Technology Directory. Wireless Capsule Endoscopy November 2003. Update performed January 2006.
  17. Hayes, Inc. Medical Technology Directory. Capsule Endoscopy for Diagnostic Imaging of the Small Bowel. Lansdale, PA: Hayes, Inc.; January 2008.
  18. Hayes, Inc. Medical Technology Directory. Capsule Endoscopy for Diagnostic Imaging of the Esophagus. Lansdale, PA: Hayes, Inc.; January 2008.
  19. Hayes, Inc. Health Technology Brief. Wireless Video Capsule Endoscopy (PillCam™ ESO) (Given Imaging Inc.) for Diagnosis of Esophageal Disease. Lansdale, PA: Hayes, Inc; January 2007.
  20. Kopylov U, Seidman EG. Role of capsule endoscopy in inflammatory bowel disease. World Journal of Gastroenterology 2014; 20(5): 1155-1164.
  21. Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006; 38(1): 36-41.
  22. Leighton JA, Legnani P, Seidman EG. Role of capsule endoscopy in inflammatory bowel disease: where we are and where we are going. Inflammatory Bowel Diseases 2007; 13(3): 331-7.
  23. Lichtenstein GR, Hanauer SB, Sandborn WJ. Management of crohn’s disease in adults. American Journal of Gastroenterology 2009.Mata A, Llach J, Castells A, Rovira JM, Pellise M, Gines A, Fernandez-Esparrach G, Andreu M, Bordas JM, Pique JM. 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.
  24. Mekaroonkamol P, Cohn R, Chawla S. Portal hypertensive enteropathy. World Journal of Hepatology 2015; 7(2): 127-138.
  25. Mishkin DS, Chuttani R, Croffie J, Disario J, Liu J, Shah R, Somogyi L, Tierney W, Song LM, Petersen BT; Technology Assessment Committee, American Society for Gastrointestinal Endoscopy. ASGE Technology Status Evaluation Report: wireless capsule endoscopy. Gastrointest Endosc. 2006; 63(4): 539-45.
  26. Mitselos IV, Christodoulou DK, Katsanos KH et al. Role of wireless capsule endoscopy in the follow-up of inflammatory bowel disease. World Journal of Gastroenterology 2015; 7(6): 643-651.
  27. Muhammad A, Pitchumoni CS. Newly detected celiac disease by wireless capsule endoscopy in older adults with iron deficiency anemia. Journal of Clinical Gastroenterology 2008; 42(9): 980-983.
  28. National Institute for Clinical Excellence (NICE). Interventional procedures overview of wireless capsule endoscopy, 06/04.
  29. Pennazio M, Rondonotti E, de Franchis R. Capsule endoscopy in neoplastic diseases. World Journal of Gastroenterology 2008; 14(34): 5245-5253.
  30. Qureshi W, Adler DG, Davila R, Egan J, Hirota W, Leighton J, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Baron TH, Faigel DO; Standards of Practice Committee. ASGE Guideline: the role of endoscopy in the management of variceal hemorrhage, updated July 2005. Gastrointest Endosc. 2005; 62(5): 651-5.
  31. Raju GS, Gerson L, Das A, Lewis B; American Gastroenterological Association. American Gastroenterological Association (AGA) Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology. 2007; 133(5): 1694-6.
  32. Ramirez FC, Shaukat MS, Young MA, Johnson DA, Akins R. Feasibility and safety of string, wireless capsule endoscopy in the diagnosis of Barrett’s esophagus. Gastrointest Endosc. 2005; 61(6): 741-6.
  33. Redondo-Cerezo E, Sanchez-Cepilla AD, De La Torre-Rubio P et al. Wireless capsule endoscopy: perspectives beyond gastrointestinal bleeding. World Journal of Gastroenterology 2014; 20(42): 15664-15673.
  34. Shen B, Remizi FH, Santisi J et al. Application of wireless capsule endoscopy for the evaluation of iron deficiency anemia in patients with ileal pouches. Journal of Clinical Gastroenterology 2008; 42(8): 897-902.
  35. Sieg A, Friedrich K, Sieg U. Is PillCam COLON capsule endoscopy ready for colorectal cancer screening? A prospective feasibility study in a community gastroenterology practice. American Journal of Gastroenterology 2009; 104(4): 848-854.
  36. Stein E, Berger Z, Hutfless S, et al. Wireless Motility Capsule versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: A Comparative Effectiveness Review. Comparative Effectiveness Review No. 110. (Prepared by Johns Hopkins Evidence-based Practice Center under Contract No. 290 2007 10061-I.) AHRQ Publication No. 13-EHC060-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2013.
  37. Triantafyllou K, Beintaris I, Dimitriadis GD. Is there a role for colon capsule endoscopy beyond colorectal cancer screening? A literature review. World Journal of Gastroenterology 2014; 20(36): 13006-13014.
  38. Trifan A, Singeap AM, Cojocariu C, et al. Small bowel tumors in patients undergoing capsule endoscopy: a single center experience. Journal of Gastrointestinal and Liver Diseases 2010; 19(1): 21-25.
  39. Van Gossum A, Munoz-Navas M, Fernandez-Urien I et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. New England Journal of Medicine 2000; 361: 264-270.
  40. Zuckerman GR, Prakash C, Askin MP, Lewis BS. AGA technical review on the evaluation and management of occult and obscure gastrointestinal bleeding. Gastroenterology. 2000; 118(1): 201-21.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/24/15.

GUIDELINE UPDATE INFORMATION:

11/15/02

New Medical Coverage Guideline.

05/15/03

Reviewed and revised; investigational status changed.

09/15/03

Added coding clarification note.

01/01/04

Annual HCPCS coding update.

05/15/04

Scheduled review and revision of guideline; consisting of updated references additional indication for coverage and deletion of G0262.

05/15/05

Scheduled review and revision of guideline; consisting of updated references.

10/15/05

Revision to guideline; consisting of the addition of an investigational statement for wireless capsule endoscopy of the esophagus and updated references.

06/15/06

Scheduled review and revision of guideline consisting of updated references.

10/30/06

Revision to guideline consisting of the addition of Program Exception verbiage for Medicare Advantage products.

01/01/07

HCPCS coding update consisting of the addition of 91111.

03/15/07

Scheduled review and revision of guideline consisting of updated references.

06/15/07

Reformatted guideline; updated references.

07/15/08

Review and revision of guideline consisting of updated references.

11/15/09

Annual review. Added experimental or investigational statement for the Given® Patency System. Added program exception for Medicare, ICD-9 codes that support medical necessity for 91110 and 91111. Updated references.

01/01/11

Revision; added related ICD-10 codes.

03/15/11

Added smart pill to section titled “Other”.

11/15/11

Annual review; maintain medical necessity position statement. Revised description; FDA statement. Updated experimental or investigational position statement, added evaluation of the colon including, but not limited to, detection of colonic polyps or colon cancer. Revised/updated definitions. Updated reference.

01/01/13

Annual HCPCS coding update; revised 91110 and 91111 code descriptor.

7/15/14

Annual review; Updated description section. Added “performed during the current episode of illness” to meets the definition of medical necessity statement; Obscure gastrointestinal (GI) bleeding suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower gastrointestinal endoscopic studies “performed during the current episode of illness”. Added “suspected small bowel tumor” to position statement. Added “ulcerative colitis” and “initial evaluation of patients with acute upper gastrointestinal bleeding (GI) bleeding to experimental or investigational statement. Added ICD-9 diagnoses codes: 211.2, 578.0, 578.1 and 759.6. Added Medicare Advantage products program exception. Updated references for 91110.

10/15/15

Review and revision; added evaluation of members with Crohn’s disease for unexpected change(s) in the course of disease or response to treatment to position statement, added Lynch syndrome, portal hypertensive enteropathy and unexplained chronic abdominal pain to the experimental or investigational position statement, revised experimental or investigational position statement, and updated references.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 26, 2017: 11:31 AM