Local Coverage Determination (LCD)

Wireless Capsule Endoscopy

L33774

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33774
Original ICD-9 LCD ID
Not Applicable
LCD Title
Wireless Capsule Endoscopy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 07/11/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Wireless Capsule Endoscopy. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Wireless Capsule Endoscopy and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, 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 resistant 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.

Covered Indications

Wireless capsule endoscopy of the small bowel is considered 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;
  • intraoperative 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.

Wireless capsule endoscopy of the esophagus is considered 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 “Covered 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 Food and Drug Administration (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.

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.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications

Wireless Capsule Endoscopy is covered 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.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Wireless Capsule Endoscopy (A56704) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.


Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Wireless Capsule Endoscopy (A56704) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number(s) – L29040, L29310, L29409

Bibliography

Appleyard M, Glukhovsky A, Swain P. Wireless-capsule diagnostic endoscopy for recurrent small-bowel bleeding. N Engl J Med. 2001; 344:232-233.

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

Eisen G, Dominitz J, Faigel D, et al. Guidelines for advanced endoscopic training. Gastrointest Endosc. 2001; 53:846-848.

Eliakim R, Fischer D, Suissa A, et al. 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. Eur J Gastroenterol and Radiol. 2003; 15(4):363-367.

Eliakim R, Yassin K, Shlomi I, Suissa A, Eisen GM. A novel diagnostic tool for detecting esophageal pathology: the PillCam oesophageal video capsule. Aliment Pharmacol Ther. 2004; 20(10):1083-1089.

Eliakim R, Sharma VK, Yassin K, et al. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gatroesophageal reflux diseases. J Clin Gastroenterol. 2005; 39(7):572-8.

Elsen GM, Eliakim R, Zaman A, et al. The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endosc. 2006; 38(1):31-35. 

Hara AK, Leighton JA, Sharma VK, Fleischer DE. Small bowel: preliminary comparison of capsule endoscopy with barium study and CT. Radiol. 2003.

Herrerias JM, Caunedo A, Tellez M, Pellicer F. Capsule endoscopy in patients with suspected Crohn’s disease and negative endoscopy. Endosc. 2003; 35(7):564-568.

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

Lapalus MG, Dumortier J, Fumex F, et al. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endosc. 2006; 38(1):36-41.

Standards of Practice Committee. ASGE Guidelines; the role of endoscopy in management of variceal hemorrhage. Gastrointest Endosc. Updated July 2005; 62(5):651-655.

Technology Assessment Committee. ASGE technology status evaluation report: wireless capsule endoscopy. Gastrointest Endosc. 2006; 63(4):539-545.

Triester SL, Leighton JA, Leontiadis GI, et al. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005; 100(11):2407-2418.

U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Class II special controls guidance document: ingestible telemetric gastrointestinal capsule imaging systems; final guidance for industry and FDA. 2001. FDA Website. Accessed July 24, 2002.

Zuckerman GR, Prakash C, Askin MP and Lewis BS. American gastroenterological association practice guidelines: AGA technical review on the evaluation and management of occult and obscure gastrointestinal bleeding. Gastroenterol. 2000; 118(1):201-221.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
07/11/2019 R4

12/06/2019: The content in the LCD was revised to be consistent with the new format supported by CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1.

  • Other
07/11/2019 R3

Revision Number: 3
Publication: July 2019 Connection
LCR A/B2019-041

Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, any ICD-10-CM diagnosis codes listed in ranges were broken out and listed individually. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

07/11/2019:  At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revisions based on CR 10901)
01/22/2019 R2

Revision Number: 2
Publication: February 2019 Connection
LCR A/B2019-005

Explanation of Revision: Based on review of the LCD, typographical and grammatical errors were corrected. The effective date of this revision is based on process date. In addition, based on CR 10901, the “CMS National Coverage Policy” section of the LCD was revised to update the section number for Pub. 100-08, Chapter 13 from 5.1 to 13.5.4. The effective date of this revision is for claims processed on or after 01/08/2019, for dates of service on or after 09/26/2018.

01/22/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revisions based on review)
02/08/2018 R1

Revision Number: 7

Publication: February 2018 Connection

LCR A/B2018-012

Explanation of Revision: This LCD was revised in the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation:” to include an explanation that all the codes within the asterisked range from the first code to the last code apply. In addition, the procedure codes in the “CPT/HCPCS Codes” section of the LCD were put in groups to be consistent with the groups in the “ICD-10 Codes that Support Medical Necessity” section of the LCD. The effective date of this revision is based onprocess date.

02/08/2018:  At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice.  This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Public Education/Guidance
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Associated Documents

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Public Versions
Updated On Effective Dates Status
12/06/2019 07/11/2019 - N/A Currently in Effect You are here
07/15/2019 07/11/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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