L29310-LCD

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Local Coverage Determination (LCD) for Wireless Capsule Endoscopy (L29310)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29310

LCD Title Wireless Capsule Endoscopy

Contractor's Determination Number 91110

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 5.1

Indications and Limitations of Coverage and/or Medical Necessity

Wireless capsule endoscopy (WCE) requires that the patient ingest a small capsule containing a disposable light source, miniature color video camera, battery, antenna and a data transmitter. The self-contained capsule is made of specially sealed biocompatible material that is resistent to the digestive fluids throughout the gastrointestinal (GI) tract. Following ingestion of the capsule, natural contraction and relaxation of the GI tract propels the capsule forward. The camera contained in the capsule records images as it travels through the digestive system. During the entire procedure, the patient wears a data recorder around the waist, which captures and stores images transmitted by the capsule’s camera. After completion of the procedure, the patient data recorder is connected to a computer workstation where the images are downloaded, reviewed, and interpreted by the physician. The procedure lasts approximately five minutes for observing the esophageal mucosa and approximately 8 hours when observing intestinal mucosa. The capsule is designed to be disposable and is excreted naturally from the body.

Indications

Medicare will consider wireless capsule endoscopy of the small bowel to be medically reasonable and necessary when the following conditions have been met:

• documented continuous blood loss and anemia secondary to obscure bleeding of the small bowel;

• the site of bleeding could not be previously identified by colonoscopy, or endoscopy, or;

• radiographic exams of the small bowel have failed to reveal a source, or;

• interaoperative enteroscopy is being considered, or;

• initial diagnosis of suspected Crohn’s Disease when there is no evidence provided by conventional diagnostic tests such as small bowel follow-through (SBFT) and upper and lower endoscopy.

Medicare will consider wireless capsule endoscopy of the esophagus to be medically reasonable and necessary for the following condition, if the criteria have been met:

• Patient diagnosed with portal hypertension who requires immediate evaluation of esophageal varices

• AND the esophageal capsule endoscopy is performed in lieu of conventional endoscopy because the provider who would perform the endoscopy has determined that the patient’s current medical condition prohibits a conventional endoscopy.

• AND the medical record clearly reflects why the patient was not a candidate for conventional endoscopy and how the capsule endoscopy would contribute to the patient’s care.

Limitations

• Wireless capsule endoscopy of the esophagus will be considered medically necessary only as specified under “Indications.” Performance of wireless capsule endoscopy for any other reason will be considered not medically necessary.

• Wireless capsule endoscopy is not reimbursable for colorectal cancer screening.

• This test is covered only for services using FDA approved devices.

• Wireless capsule endoscopy is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (proximal to the ligament of Treitz, or distal to the ileum).

• The use of wireless capsule endoscopy should not be used in patients with a cardiac pacemaker, or other implanted electromagnetic device.

• This test is not indicated for patients in whom a radiological exam of the small bowel has confirmed an intestinal blockage, a significantly narrow small bowel, or an abnormal connection between the bowel and another organ.

• An x-ray exam of the small bowel should be done if there is concern that it may be too narrow for the camera to pass.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

91110 GASTROINTESTINAL TRACT IMAGING, INTRALUMINAL (EG, CAPSULE ENDOSCOPY), ESOPHAGUS THROUGH ILEUM, WITH PHYSICIAN INTERPRETATION AND REPORT

91111 GASTROINTESTINAL TRACT IMAGING, INTRALUMINAL (EG, CAPSULE ENDOSCOPY), ESOPHAGUS WITH PHYSICIAN INTERPRETATION AND REPORT

ICD-9 Codes that Support Medical Necessity

Use for wireless capsule endoscopy of the small bowel (CPT code 91110)

280.0 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

280.9 IRON DEFICIENCY ANEMIA UNSPECIFIED

555.0 REGIONAL ENTERITIS OF SMALL INTESTINE

555.2 REGIONAL ENTERITIS OF SMALL INTESTINE WITH LARGE INTESTINE

555.9 REGIONAL ENTERITIS OF UNSPECIFIED SITE

562.2 DIVERTICULOSIS OF SMALL INTESTINE WITH HEMORRHAGE

562.3 DIVERTICULITIS OF SMALL INTESTINE WITH HEMORRHAGE

569.85 ANGIODYSPLASIA OF INTESTINE WITH HEMORRHAGE

578.9 HEMORRHAGE OF GASTROINTESTINAL TRACT UNSPECIFIED Use for wireless capsule endoscopy of the esophagus (CPT code 91111)

* For billing wireless capsule endoscopy of the esophagus a dual diagnosis of 572.3 and 456.20 or 456.21 is required.

456.20 - 456.21 opens in ESOPHAGEAL VARICES IN DISEASES CLASSIFIED ELSEWHERE WITH BLEEDING - ESOPHAGEAL VARICES IN DISEASES CLASSIFIED ELSEWHERE WITHOUT BLEEDING

572.3 PORTAL HYPERTENSION

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity xx000

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the treating provider must substantiate the medical necessity of the services being billed. In addition, documentation that the service was performed must be included in the patient’s medical record. This information is normally found in the history and physical, office/progress notes, hospital notes, and/or procedure report.

Documentation must support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy.

The record must include documentation that attempts were made to identify the source of the bleeding, but the site of bleeding was not previously identified by colonoscopy, or endoscopy.

The medical record must clearly reflect why the patient was not a candidate for conventional endoscopy. There must be documentation of specific co-morbidities and complicating medical conditions that lead the performing provider of the conventional endoscopy to believe that the risk/benefit ratio of a conventional endoscopy was not maintained. The medical record must also support how the capsule endoscopy would contribute to the patient’scare.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to medical review.

Wireless capsule endoscopy of the small bowel is payable only once per episode of illness for patients who have previously undergone an upper GI endoscopy, and lower GI colonoscopy, but have failed to reveal a source of bleeding. An episode of illness is defined as the time frame from the onset of signs and symptoms until the GI bleeding is resolved.

When performed only by providers of gastroenterology and radiology services or other providers who have specialized training and expertise in performing wireless capsule endoscopy. Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty. If this skill has been acquired as continuing medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit.

Sources of Information and Basis for Decision

Appleyard, M., Glukhovsky, A., Swain, P., (2001). Wireless-capsule diagnostic endoscopy for recurrent small- bowel bleeding. New England Journal of Medicine, 344, 232-233. This source was used to describe the procedure.

Apostolopoulos, P. (2006) The role of wireless capsule endoscopy in investigating unexplained iron deficiency anemia after negative endoscopic evaluation of the upper and lower gastrointestinal tract. Endoscopy 38(11): 1127-1132.

Eisen, G., Dominitz, J., Faigel, D., Goldstein, J., Kallo, A., Peterson, B., Raddawi, H., Ryan, M., Vargo, J., Young, H., Fanelli. R., Hyman, N., Wheeler-Harbaugh, J. (2001). Guidelines for advanced endoscopic training.

Gastrointestinal Endoscopy, 53, 846-848. This source was used to define appropriate medically necessity conditions.

Eliakim, R. et al (2003) Wireless capsule video endoscopy is a superior diagnostic tool in comparison to barium follow-through and computerized tomography in patients with suspected Crohn’s disease. European Journal of Gastroenterology and Radiology, 15: 1-5. This source used to support the use of WCE for initial diagnosis of Crohn’s disease when there is no evidence provided by conventional diagnostic tests.

Eliakim, R et al (2004) A novel diagnostic tool for detecting oesophageal pathology: the PillCam oesophageal video capsule. Aliment Pharmacol Ther Nov 2004; 20: 1083-1089.

Eliakim, R et al (2005) A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gatroesophageal reflux diseases. Journal of Clinical Gastroenterology Aug 39(7): 572-8.

Elsen, GM et al (2005) The accurancy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study Endoscopy 38:1-5. This source used to compare the efficacy of PillCam vs conventional methods.

Hara, A. K. et al (2003) Small bowel: preliminary comparison of capsule endoscopy with barium study and CT. Radiology 2003. This source used to identify the accuracy of WCE when used as a diagnostic tool for small bowel symptoms.

Herrerias, J. M. et al (2003) Capsule endoscopy in patient’s with suspected Crohn’s disease and negative endoscopy. Endoscopy, 53: 564-568. This source used to support the use of WCE for initial diagnosis of Crohn’s disease when not identified with conventional diagnostic tests.

ICCE Consensus for the Esophagus 4th International Conference on Capsule Endoscopy (ICCE) March 5-8, 2005.

Lapalus, M.G., et al. (2006). Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy 38: 36-41. This source used to identify the pros and cons of using wireless capsule endoscopy vs conventional methods.

Standards of Practice Committee (2005). ASGE Guidelines; the role of endoscopy in management of variceal hemorrhage, updated July 2005. Gastrointestinal Endoscopyu 62, 5: 651-655. This source used to compare the use of endoscopic sclerotherapy (EST) to endoscopic variceal ligation (EVL) in the management of variceal hemorrhages.

Technology Assessment Committee (2006). ASGE technology status evaluation report: wireless capsule endoscopy. Gastrointestinal Endoscopy 63, 4: 539-545. This source used to review guideline recommendations from the American Society for Gastrointestinal Endoscopy based on the organization’s technology review.

Triester, S. L., et al (2005) A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. American Journal of Gastroenterology 100: 2407- 2418.

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (2001). Class II special controls guidance document: ingestible telemetric gastrointestinal capsule imaging systems; final guidance for industry and FDA. . (Online) July 24, 2002, Internet, available: http://www.fda.gov/cdrh/ode/guidance/1385.html. This source was used to provide limitations of use.

Zuckerman, G. R., Prakash, C., Askin, M. P. and Lewis, B. S. (2000). American gastroenterological association practice guidelines: AGA technical review on the evaluation and management of occult and obscure gastrointestinal bleeding. Gastroenterology, 118, 201-221. This source was used to define appropriate medical necessity conditions.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29310) replaces LCD L13831 as the policy in notice. This document (L29310) is effective on 02/02/2009.

Reason for Change