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Local Coverage Determination (LCD)

Wireless Capsule Endoscopy

L36427

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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
L36427
Original ICD-9 LCD ID
Not Applicable
LCD Title
Wireless Capsule Endoscopy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36427
Original Effective Date
For services performed on or after 01/25/2016
Revision Effective Date
For services performed on or after 10/28/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
04/20/2017
Notice Period End Date
06/04/2017

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Issue

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

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

42 CFR 410.32(a) indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements)

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §100.2 Endoscopy

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Wireless capsule endoscopic imaging is intended as an adjunctive tool in the detection of certain gastrointestinal (GI) conditions. This procedure requires that a 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 GI tract. Following ingestion of the capsule, natural contraction and relaxation of the GI tract propels the camera forward. The camera contained in the capsule records images of the intestinal mucosa as it travels the length of the digestive system. During the entire procedure, which normally takes approximately 8 hours, the patient wears a data recorder around the waist, which captures and stores the 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 capsule is designed to be disposable and is excreted naturally from the body.

Indications for wireless capsule endoscopy:

• For investigating suspected small intestinal bleeding in persons with objective evidence of recurrent, obscure GI bleeding (e.g., persistent or recurrent iron-deficiency anemia and/or persistent or recurrent positive fecal occult blood test (FOBT), or visible bleeding) who have had upper and lower GI endoscopies within the past 12 months (esophagogastroduodenoscopy (EGD) and colonoscopy) that have failed to identify a bleeding source;

• For evaluation of regional non-metastatic carcinoid tumors of the small bowel in persons with carcinoid syndrome;

• For evaluation of persons with celiac disease with a positive serology and negative biopsy;

• For re-evaluation of persons with celiac disease who remain symptomatic despite treatment and there is no suspected or confirmed GI obstruction, stricture, or fistulae;

• For initial diagnosis in persons with suspected Crohn's disease (abdominal pain or diarrhea plus 1 or more signs of inflammation (e.g., fever, elevated white blood cell (WBC) count, elevated erythrocyte sedimentation rate, or bleeding) without evidence of disease on conventional diagnostic tests, including small-bowel follow-through or abdominal computed tomography (CT) scan/CT enterography and upper and lower endoscopy (EGD and colonoscopy);

• For re-evaluation of persons with Crohn's disease who remain symptomatic despite treatment and there is no suspected or confirmed GI obstruction, stricture, or fistulae;

• For surveillance of small intestinal tumors in persons with Lynch syndrome, Peutz-Jeghers syndrome and other polyposis syndromes affecting the small bowel; or

• For screening or surveillance of esophageal varices.

Limitations of use:

Wireless capsule endoscopy:

• is NOT indicated for repeat use to verify the effectiveness of surgery.

• is NOT indicated for use as a screening test (other than esophageal varices) and is NOT reimbursable for colorectal cancer screening.

• is NOT indicated for use as an initial test in diagnosing GI bleeding.

• is NOT indicated for use for evaluating intussusception.

• is NOT indicated for use for evaluating the colon, as it is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (lesions proximal to the ligament of Treitz, or distal to the ileum).

• is NOT indicated for use for evaluating diseases involving the esophagus other than esophageal varices.

• is NOT indicated for use for follow-up of persons with known small bowel disease other than Crohn's disease.

• is NOT indicated for use in confirming pathology identified by other diagnostic means.

• is NOT indicated for use in evaluating the stomach, as it is not indicated for the confirmation of lesions of pathology normally within the reach of upper and lower endoscopes (lesions proximal to the ligament of Treitz, or distal to the ileum).

• is NOT indicated for use in investigating duodenal lymphocytosis, small bowel neoplasm, or suspected irritable bowel syndrome (IBS).

Wireless capsule endoscopy is covered only for services using United States (U.S.) Food and Drug Administration (FDA) approved devices and is not indicated for patients in whom a GI blockage is known or suspected, who have a significantly narrow small bowel, or have a known or suspected abnormal connection between the bowel and/or another organ (e.g., strictures or fistulas). 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 through.

Wireless capsule endoscopy should not be employed in patients with a cardiac pacemaker, or other implanted electromedical devices, or in patients who are pregnant.

In addition to any specific limitations noted above, wireless capsule endoscopy is limited as follows:

• This test is only covered when performed by physicians trained in endoscopy or for independent diagnostic testing facilities (IDTF), which are under the general supervision of a physician trained in endoscopy procedures.

• The capsule should be ingested at least 12 hours after the last meal, and the patient should not be allowed to eat for an additional 3 hours after the capsule is swallowed. Stool in the bowel may cause obstruction of images and result in failure of the study.

Medicare would not expect to see a second capsule administered per episode of illness unless it was to guarantee an adequate examination (e.g., the initial capsule does not penetrate the pylorus). Please note that any other procedures that are employed to ensure proper passage of the capsule must be reasonable and necessary and documented appropriately.

Medicare expects repeat wireless capsule endoscopic studies for any patient to be for medically reasonable and necessary clinical circumstances consistent with accepted standards of medical practice and that the medical records demonstrate such.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
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
View Letter
N/A
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

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

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

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.
Sources of Information

N/A
Bibliography

Bhardwaj A, Hollenbeak CS, Pooran N, Mathew A. A meta-analysis of the diagnostic accuracy of esophageal capsule endoscopy for Barrett's esophagus in patients with gastroesophageal reflux disease. The American Journal of Gastroenterology. 2009;104(6):1533-1539.

Bordeianou L, Yeh DD. Epidemiology, clinical features, and diagnosis of mechanical small bowel obstruction in adults. UptoDate; 2017.

de Franchis R, Eisen GM, Eliakim AR, et al. Esophageal capsule endoscopy (Pillcam ESO) is comparable to traditional endoscopy for detection of esophageal varices - an international multi-center trial. Gastrointestinal Endoscopy. 2007;65(5):AB107.

Dionisio PM, Gurudu SR, Leighton JA, et al. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel crohn's disease: A meta-analysis. The American Journal of Gastroenterology. 2010;105(6):1240-1248.

Koornstra JJ, Kleibeuker JH, Vasen HF. Small-bowel cancer in lynch syndrome: Is it time for surveillance? Lancet Oncology. 2008;9(9):901-905.

Lewis B, Swain P. Capsule endoscopy in the evaluation of patients with suspected small intestinal bleeding: Results of a pilot study. Gastrointestinal Endoscopy. 2002;56(3):349-353.

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. Gastrointestinal Endoscopy. 2007;65(4):577-583.

Mishkin DS, Chuttani R, Croffie J, et al. ASGE technology status evaluation report: Wireless capsule endoscopy. Gastrointestinal Endoscopy. 2006;63(4):539-545.

Raju GS, Gerson L, Das A, Lewis B. American Gastroenterological Association (AGA) Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology. 2007;133(5):1694-1696.

Rokkas T, Niv Y. The role of video capsule endoscopy in the diagnosis of celiac disease: A meta-analysis. European Journal of Gastroenterology & Hepatology. 2012;24(3):303-308.

Scapa E, Jacob H, Lewkowicz S, et al. Initial experience of wireless-capsule endoscopy for evaluating occult gastrointestinal bleeding and suspected small bowel pathology. The American Journal of Gastroenterology. 2002;97(11):2776-2779.

Sharma P, Wani S, Rastogi A, et al. The diagnostic accuracy of esophageal capsule endoscopy in patients with gastroesophageal reflux disease and Barrett’s esophagus: A blinded, prospective study. The American Journal of Gastroenterology. 2008;103(3):525-532.

Triantafyllou K, Tsibouris P, Kalantzis C, et al. PillCam colon capsule endoscopy does not always complement incomplete colonoscopy. Gastrointestinal Endoscopy. 2009;69(3 Pt 1):572-576.

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. The American Journal of Gastroenterology. 2005;100(11):2407-2418.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/28/2021 R12

Under CMS National Coverage Policy updated section headings for regulations. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Typographical errors were corrected throughout the LCD.
  • Provider Education/Guidance
10/24/2019 R11

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Wireless Capsule Endoscopy A56727 article.

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
07/25/2019 R10

All coding located in the Coding Information section has been moved into the related Billing and Coding: Wireless Capsule Endoscopy A56727 article and removed from the LCD.

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
07/11/2019 R9

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD. CPT® was inserted throughout the LCD where applicable. 

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
04/19/2018 R8

Under Coverage Indications, Limitations and/or Medical Necessity added (GI) after the word “gastrointestinal” in the first sentence and subsequently replaced this word with “GI” each time the word was used. Under Coverage Indications, Limitations and/or Medical – Indications for wireless capsule endoscopy replaced “EGD” with “esophagogastroduodenoscopy (EGD)”, and removed “or” from the end of each bullet with the exception of the seventh bullet. Under Coverage Indications, Limitations and/or Medical – Limitations of use corrected the spelling for intussusception. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The first reference was replaced with the current citation information. The authors’ names were corrected on the fourth and eighth reference, and the titles were corrected on the fifth, sixth and seventh reference.

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
  • Typographical Error
02/26/2018 R7 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R6 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R5

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes K56.51, K56.600, K56.690 and K91.31. This revision is due to the 2017 Annual ICD-10 Code Updates.

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
  • Revisions Due To ICD-10-CM Code Changes
06/05/2017 R4 Under ICD-10 Codes that Support Medical Necessity Group 1: Paragraph deleted Covered if criteria are met for 91110 only and added Covered if criteria are met for 91110. If the procedure is performed for a covered diagnosis in Group 1 but the study cannot be completed in a circumstance where the capsule is unable to pass the pyloric junction, the incomplete study should be billed as CPT 91111 with a Group 1 ICD-10 code. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph deleted Covered if criteria are met for 91111 only and added CPT 91111 should be billed with a Group 2 ICD-10 code when the purpose of the study is to examine only the esophagus to the level of the gastroesophageal junction.
  • Provider Education/Guidance
05/05/2017 R3 Under ICD-10 Codes that Support Medical Necessity- added Q85.8 to Group 1.
  • Provider Education/Guidance
10/01/2016 R2 Annual validation performed on 12/1/16. No revisions were required.
  • Other (Annual Validation)
10/01/2016 R1 Under ICD-10 Codes That Support Medical Necessity: Group 1 added K55.011, K55.012, K55.019, K55.021, K55.022, K55.029, K55.051, K55.052, K55.059, K55.061, K55.062, K55.069, K55.30, K55.31, K55.32, and K55.33. Under ICD-10 Codes That Support Medical Necessity: Group 1 deleted K52.2. This revision is due to the Annual ICD-10 Code Update.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
N/A

Associated Documents

Attachments
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Related National Coverage Documents
NCDs
100.2 - Endoscopy
Public Versions
Updated On Effective Dates Status
10/22/2021 10/28/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Wireless Capsule Endoscopy
  • Capsule Endoscopy

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