3A325-Wireless Capsule Endoscopy: Medical Necessity and Documentation Review.

Dynamic List Information
Dynamic List Data
Issue Name
3A325-Wireless Capsule Endoscopy: Medical Necessity and Documentation Review.
Review Type
Complex
Provider Type
Outpatient Hospital (OP), Ambulatory Surgical Center (ASC), Professional Services
MAC Jurisdiction
JN, JJ, JH, JL
Date
2024-11-12
RAC Type
Proposed

Description

Wireless capsule endoscopic (WCE) 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. Documentation will be reviewed to determine whether capsule endoscopy services met Medicare coverage criteria and were reasonable and necessary.

Affected Code(s)

91110, 91111

Applicable Policy References

1.    Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer
2.    Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(7)-This section excludes routine physical examinations
3.    Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits
4.    42 CFR §405.929- Post-Payment Review
5.    42 CFR §405.930- Failure to Respond to Additional Documentation Request
6.    42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Initiated by a Contractor; and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party
7.    42 CFR §405.986- Good Cause for Reopening
8.    42 CFR §410.32(d)(3)- Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
9.    42 CFR §410.33- Independent diagnostic testing facility
10.    42 CFR §414.50- Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier
11.    42 CFR §414.510- Laboratory date of service for clinical laboratory and pathology specimens
12.    Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §210.3 Colorectal Cancer Screening Tests
13.    Medicare Benefit Policy Manual, Chapter 14, §10- Coverage of Medical Devices

14.    Medicare Claims Processing Manual, Chapter 23, §30- Services paid under the Medicare Physicians Fee Schedule
15.    Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §§3.1- 3.6.6
16.    Medicare Program Integrity Manual, Chapter 13, §5.1- Reasonable and necessary provisions in LCDs
17.    FCSO, Inc., Local Coverage Determination L33774 – Wireless Capsule Endoscopy; Effective 10/01/2015; Revised 07/11/2019
18.    FCSO, Inc., Local Coverage Article A56704 – Billing and Coding: Wireless Capsule Endoscopy; Effective 10/03/2018; Revised 03/10/2022
19.    Palmetto GBA Local Coverage Determination L36427 – Wireless Capsule Endoscopy; Effective 01/25/2016; Revised 10/28/2021
20.    Palmetto GBA Local Coverage Article A56727 – Billing and Coding: Wireless Capsule Endoscopy; Effective 07/25/2019; Revised 10/01/2023
21.    Novitas Local Coverage Determination L35089 – Wireless Capsule Endoscopy; Effective 10/01/2015; Revised 11/21/2019
22.    Novitas Local Coverage Article A57753 - Billing and Coding: Wireless Capsule Endoscopy; Effective 11/21/2019; Revised 01/01/2022 
23.    AMA CPT Codebook