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LCD L38807: Colon Capsule Endoscopy (CCE)

LCD L38807, Colon Capsule Endoscopy (CCE), is the Local Coverage Determination that Novitas Solutions, Inc. applies to claims from 12 states (AR, CO, DC, DE, LA, MD, MS, NJ and others), effective 2021-03-28. The policy text runs 539 words, and its billing and coding article A58414 lists 6 ICD-10-CM codes that support medical necessity for 1 procedure codes. 6 other contractors publish a policy with the same title, so the criteria that apply depend on where the service is furnished.

QuickIntell editorial content · Legacy registry date · Review not verified

Data effective
Data currency: Medicare Coverage Database LCD export release of September 24, 2026 (effective September 20, 2026). Next CMS release: weekly (Thursdays) for the MCD.
Contractor
Novitas Solutions, Inc.
States and territories
12
AR CO DC DE LA MD MS NJ NM OK PA TX
Revision effective
2021-03-28
Original effective
2021-03-28
Policy text
539 words
Covered ICD-10 codes (articles)
6

Where this LCD applies

Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.

Contracts that apply LCD L38807
ContractContractorTypeStates
12101Novitas Solutions, Inc.A and B MACDE
12201Novitas Solutions, Inc.A and B MACDC
12301Novitas Solutions, Inc.A and B MACMD
12401Novitas Solutions, Inc.A and B MACNJ
12501Novitas Solutions, Inc.A and B MACPA
12102Novitas Solutions, Inc.A and B MACDE
12202Novitas Solutions, Inc.A and B MACDC
12302Novitas Solutions, Inc.A and B MACMD
12402Novitas Solutions, Inc.A and B MACNJ
12502Novitas Solutions, Inc.A and B MACPA
12901Novitas Solutions, Inc.A and B MACDC DE MD NJ PA
07102Novitas Solutions, Inc.A and B MACAR
07202Novitas Solutions, Inc.A and B MACLA
07101Novitas Solutions, Inc.A and B MACAR
07201Novitas Solutions, Inc.A and B MACLA
07301Novitas Solutions, Inc.A and B MACMS
07302Novitas Solutions, Inc.A and B MACMS
04111Novitas Solutions, Inc.A and B MACCO
04211Novitas Solutions, Inc.A and B MACNM
04311Novitas Solutions, Inc.A and B MACOK
04411Novitas Solutions, Inc.A and B MACTX
04112Novitas Solutions, Inc.A and B MACCO
04212Novitas Solutions, Inc.A and B MACNM
04312Novitas Solutions, Inc.A and B MACOK
04412Novitas Solutions, Inc.A and B MACTX
04911Novitas Solutions, Inc.A and B MACCO NM OK TX

Billing and coding: diagnoses and procedure codes

Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A58414 (Billing and Coding: Colon Capsule Endoscopy (CCE)) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.

A58414: Billing and Coding: Colon Capsule Endoscopy (CCE) (Billing and Coding, effective 2022-01-01)

Covered ICD-10-CM codes
6
1 group
Non-covered ICD-10-CM codes
0
Procedure codes listed
1
Full article
cms.gov record
First 6 covered ICD-10-CM codes in A58414
ICD-10-CMDescription (FY2027)
K63.5—
K92.1—
K92.2—
R19.5—
Z53.09—
Z53.8—

Procedure codes: 91113.

Coverage indications, limitations and 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

Colon Capsule Endoscopy (CCE) is a noninvasive procedure that does not require air inflation or sedation and allows for minimally invasive and painless colonic evaluation. CCE utilizes a tiny wireless camera that takes pictures of the gastrointestinal tract. The wireless camera is housed inside a vitamin-size capsule that is swallowed with water. As the capsule travels through the digestive tract, the camera system takes pictures. The images are then transmitted to a computer with special software where the images are strung together to create a video. The provider reviews the video to look for any abnormalities within the gastrointestinal tract.

Definitions (U.S. Multisociety Taskforce)

Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such. 1

Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. 1

Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. 1

Covered Indications

For diagnostic and/or surveillance purposes, Colon Capsule Endoscopy (CCE) is medically necessary when EITHER of the following criteria are met:

• Primary procedure in patients with major risks for Optical Colonoscopy (OC) or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training and EITHER of the following criteria are met 2 :

• Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR

• Multitarget Stool DNA (sDNA) Test positive OR

• Other evidence of lower GI bleeding in hemodynamically stable patients

• Secondary procedure:

• For the detection or surveillance of colon polyp(s) if the diagnostic OC was incomplete OR

• When an incomplete diagnostic OC was performed for either:

• Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR

• Multitarget Stool DNA (sDNA) Test positive OR

• Other evidence of lower GI bleeding in hemodynamically stable patients

Limitations

The following are considered not medically reasonable and necessary:

• Patients with known or suspected gastrointestinal obstruction, stricture, or fistula.

• Patients with a cardiac pacemaker or another implanted electro-medical device that emits a radiofrequency or other interfering signal.

• Patients with swallowing disorder(s).

• Patients with a known contraindication or allergy to any medication or preparation agent used before or during the procedure.

• When performed in conjunction with CT Colonography (CTC).

• CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease. Please refer to NCD 210.3 for colorectal cancer screening coverage.

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 (opening)

Clinical Literature

The first-generation device had low sensitivity and specificity for polyps in the colon, however, a second-generation device received FDA clearance in January 2014 and expanded use in January 2016. 3,4 The improved design is slightly bigger with two cameras and an increased angle of view, allowing nearly 360-degree coverage of the colon. The capsule battery lasts 10 hours with a slower frame rate. Improvements in software allow estimation of polyp size and improved mucosal surface evaluation. Unless indicated, a reference to CCE is specific to the second-generation device. Both FDA indications are specific to colon polyp detection, but whereas the original restricted to use as a secondary procedure after failed OC, the expanded indication included use as a primary procedure in patients at major risk for colonoscopy or moderate sedation, and with evidence of lower GI bleeding.

The pivotal trial that led to FDA clearance was a prospective blinded study of 884 asymptomatic patients classified as average colorectal cancer (CRC) risk. 5 Technical failures (short transit time plus poor preparation) occurred in 9% of patients. The authors conclude based on polyp detection sensitivity and specificity data that: “capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies.”

Two studies comparing CCE to CTC demonstrated at least non-inferiority in terms of sensitivity and specificity. 6,7 One found improved sensitivity and specificity for CCE, but both studies had methodological flaws with low-quality evidence. The advantages of CTC include the ability to use when obstruction or stricture is a concern and to obtain visualization of other abdominal structures. Advantages to CCE are the lack of radiation exposure and direct visualization of colorectal mucosa. Patient preference and availability of the technology also may play a role in test selection.

The contractor cites 23 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.

Dates, lineage and related policies

Original determination effective
2021-03-28
Current revision effective
2021-03-28
MCD version
7

The contractor lists 2 National Coverage Determinations as related: NCD 210.3 Colorectal Cancer Screening Tests, NCD 100.2 Endoscopy. Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.

Using this policy on a claim

Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Novitas Solutions, Inc. hub lists every other active policy from the same contractor.

The same policy title at other contractors

Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.

Frequently asked questions

What does LCD L38807 cover?

Colon Capsule Endoscopy (CCE) is a noninvasive procedure that does not require air inflation or sedation and allows for minimally invasive and painless colonic evaluation. CCE utilizes a tiny wireless camera that takes pictures of the gastrointestinal tract. The wireless camera is housed inside a vitamin-size capsule that is swallowed with water. As the capsule travels through the digestive tract, the camera system… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.

Which states does LCD L38807 apply to?

Novitas Solutions, Inc. applies it to Medicare claims in AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.

Which diagnosis codes support medical necessity under LCD L38807?

The companion billing and coding article A58414 lists 6 ICD-10-CM codes in 1 group that support medical necessity; the first 6 appear on this page and the complete list is in the article on cms.gov.

How do I appeal a denial under LCD L38807?

The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.

Disclaimer

The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.