Local Coverage Determination (LCD)

Wireless Capsule Endoscopy

L35089

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Novitas Solutions, Inc.	A and B MAC	04111 - MAC A	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04112 - MAC B	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04211 - MAC A	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04212 - MAC B	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04311 - MAC A	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04312 - MAC B	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04411 - MAC A	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04412 - MAC B	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04911 - MAC A	J - H	Colorado New Mexico Oklahoma Texas
Novitas Solutions, Inc.	A and B MAC	07101 - MAC A	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07102 - MAC B	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07201 - MAC A	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07202 - MAC B	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07301 - MAC A	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	07302 - MAC B	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	12101 - MAC A	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12102 - MAC B	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12201 - MAC A	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12202 - MAC B	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12301 - MAC A	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12302 - MAC B	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12401 - MAC A	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12402 - MAC B	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12501 - MAC A	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12502 - MAC B	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12901 - MAC A	J - L	Delaware District of Columbia Maryland New Jersey Pennsylvania

LCD Information

Document Information

LCD ID
L35089

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 11/21/2019

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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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:

IOM Citations:

CMS IOM 100-02, Medicare Benefit Policy Manual,

Chapter 6 Hospital Services Covered Under Part B, Section 20.4: Outpatient Diagnostic Services.
Chapter 15 Covered Medical and Other Health Services, Section 80: Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests.

CMS IOM 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 100.2: Endoscopy.
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13 Local Coverage Determinations, 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 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
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.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

This LCD pertains to Wireless Capsule Endoscopy (WCE) diagnostic modality in the gastrointestinal tract.

Covered Indications

WCE is indicated for the diagnosis of occult gastrointestinal bleeding (i.e., likely involving the small intestine), the site of which has not previously been identified by any of the following: upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging or radiological procedures.
WCE is limited to those patients who have undergone upper GI endoscopy and colonoscopy and these tests have failed to reveal a source of bleeding. Medicare would not expect to see a WCE provided if upper and lower endoscopy has not previously been performed. Documentation in the medical record must indicate that the beneficiary has suspected GI blood loss with or without anemia. Appropriate differential diagnoses for the evaluation of such bleeding include:

Angiodysplasia
Neoplasm
Iron deficiency anemia, which is unexplained after upper and lower endoscopy
Zollinger-Ellison syndrome
Tuberculosis
Vasculitis
Radiation enteritis
Meckels diverticulum
Jejunal diverticula
Chronic mesenteric ischemia

Other indications include the management of celiac disease (e.g., surveillance for small-intestinal cancer) and of Crohn’s disease (that is, either Crohn’s disease is suspected, but not diagnosed, or colonic involvement of Crohn’s disease is known, but it is necessary to determine whether there is also involvement of the small bowel). In addition, WCE is indicated where an indeterminate type of colitis exists, but where a more specific diagnosis is being sought via small bowel evaluation.
Esophageal capsule endoscopy may be used in the evaluation of esophageal varices in patients with portal hypertension, as an alternative to upper GI endoscopy.

Limitations

In addition to any specific indications noted above, WCE is limited as follows:

Erosive esophagitis and Barrett’s esophagus may be viable clinical indications in the future, but further peer-reviewed literature is being sought before this additional coverage might become available.
This test is not reimbursable for colorectal cancer screening.
The test is payable only for services using FDA-approved devices.
This test is not reimbursable for the confirmation of lesions or pathology normally within the reach of upper or lower endoscopes (lesions proximal to the ligament of Treitz or distal to the ileum).
This test is only covered when performed by physicians trained in endoscopy or for independent diagnostic testing facilities, which are under the general supervision of a physician trained in endoscopy procedures.
Contraindications include: pregnancy, cardiac pacemaker and other implanted electro-medical devices, swallowing disorders, known or suspected GI obstruction, strictures or fistulas based on the clinical picture or preprocedure testing.
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 procedure codes that are used 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.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

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

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

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

Additional ICD-10 Information

General Information

Associated Information

Refer to the Local Coverage Article: Billing and Coding: Wireless Capsule Endoscopy, A57753, for all coding information.

Documentation Requirements

All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
The medical record documentation must support the medical necessity of the services as stated in this policy.
Providers shall maintain the full electronic compendia for wireless capsule endoscopy, rather than only archiving selected images.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Sources of Information

Contractor is not responsible for the continued viability of websites listed.

Other Contractor Policies

Contractor Medical Directors

Original JH ICD-9 Source LCD L32686, Wireless Capsule Endoscopy

Bibliography

ASGE Technology Status Evaluation Report: Wireless Capsule Endoscopy. Gastrointestinal Endoscopy. 2006:63(4).

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
11/21/2019	R5	LCD revised and published on 11/21/2019. Consistent with CMS Change Request 10901, the entire coding section has been removed from the LCD and placed into the related Billing and Coding Article, A57753. Language from the CMS manuals has been removed and replaced with references to the manuals. All CPT codes and coding information within the text of the LCD has been placed in the Billing and Coding Article.	Other (CMS Change Request 10901)
03/08/2018	R4	LCD revised on 04/12/2018 to correct a minor typo. No change has been made to the content of the policy.	Typographical Error
03/08/2018	R3	LCD revised and published on 03/08/2018 to update IOM Citations and policy template per LCD Annual Review. 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; therefore, not all the fields included on the LCD are applicable as noted in this policy.	Other (Annual Review)
10/01/2016	R2	LCD revised and published on 09/29/2016 effective for dates of service on and after 10/01/2016 to reflect the ICD-10 Annual Code Updates. The following ICD-10 codes have been added to the Group 1 diagnosis code list: C49.A3 and C49.A4.	Revisions Due To ICD-10-CM Code Changes
10/01/2015	R1	LCD revised and published on 12/10/2015 effective for dates of service on and after 10/01/2015. The following ICD-10 codes have been added to the group 1 diagnosis codes; D37.2, D50.0, K57.51 and K57.53 to allow for greater specificity.	Other (Additional diagnosis codes added for higher specificity.)

Associated Documents

Attachments
N/A

Related Local Coverage Documents
Articles
A57753 - Billing and Coding: Wireless Capsule Endoscopy

Related National Coverage Documents
NCDs
100.2 - Endoscopy

Public Versions

Updated On	Effective Dates	Status
11/15/2019	11/21/2019 - N/A	Currently in Effect	You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

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Wireless Capsule Endoscopy

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Issue

CMS National Coverage Policy

Coverage Guidance

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

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

Group 1

Additional ICD-10 Information

General Information

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