CurrentKaiser PermanentePolicy N/A

Capsule Endoscopy (including Patency Capsule / PillCam / PillCam SB / Colon Capsule)

Clinical review criteria governing medical necessity determinations for capsule endoscopy (small bowel and colon) and patency capsule use for Kaiser Foundation Health Plan of Washington members; includes Medicare/LCD references and notes MCG use for non-Medicare determinations. Lists applicable CPT codes and documentation requirements.

Policy Summary

PayerKaiser Permanente

PolicyCapsule Endoscopy (including Patency Capsule / PillCam / PillCam SB / Colon Capsule)

Policy CodePolicy N/A

Change TypeRevised / Added code / Medicare LCD added

Effective DateN/A

Next Review DateN/A

Key ActionWhen requesting capsule endoscopy, submit the last 12 months of clinical notes from the requesting provider and/or gastroenterology specialist and most recent laboratory work to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

03/12/2024 MPC approved the modified hybrid criteria for capsule endoscopy effective August 1, 2024 with 60-day notice required.

10/05/2021 Added Colon Capsule Endoscopy LCD/LCA for Medicare.

12/08/2022 Added applicable new CPT code to criteria; removed applicable deleted CPT code.

3Primary CPT codes listed

1Medicare LCD referenced (CCE L38824)

MCGNon-Medicare criteria source (MCG)

This policy governs medical necessity determinations for capsule endoscopy (swallowable wireless video capsules such as PillCam/M2A and colon capsule) used primarily to evaluate obscure gastrointestinal bleeding (OGIB) and suspected small bowel pathology, and addresses use of the AGILE Patency System to assess gastrointestinal patency in patients at risk for capsule retention. For Medicare members the policy references the applicable Local Coverage Determination for Colon Capsule Endoscopy (L38824) and its Local Coverage Article (A58436), while non‑Medicare determinations refer to MCG guidance per the policy.

Quick facts

Primary CPT codes listed91110, 91111, 91113

Medicare LCD referencedColon Capsule Endoscopy (L38824) and Local Coverage Article A58436

Non‑Medicare criteria sourceMCG Capsule Endoscopy (KP-0134 08012024) used for non‑Medicare determinations

Provider Actions

Documentation Required

Submit supporting clinical documentation

When requesting capsule endoscopy, submit clinical documentation from the last 12 months and the most recent laboratory results to support medical necessity. Include notes from the requesting provider and/or gastroenterology specialist.

Examples: office visit notes, consultation notes, endoscopy reports, recent CBC or iron studies

Prior Authorization

Verify authorization requirements

Verify pre-authorization requirements for capsule endoscopy codes by plan type using the Pre-authorization Code Check before scheduling or billing.

91110
91111
91113

Documentation Required

Medicare-specific LCD/LCA compliance for Colon Capsule Endoscopy

For Medicare members, follow the applicable Local Coverage Determination and Local Coverage Article for Colon Capsule Endoscopy when billing and determining coverage.

LCD L38824
LCA A58436

Background & Evidence

Capsule endoscopy devices (eg, M2A/PillCam) are pill‑sized, swallowable wireless video capsules containing a camera, light source, transmitter and batteries that transmit images of the small bowel to an external recorder for later review; the PillCam received FDA approval in 2001. The AGILE Patency Capsule is a dissolvable lactose‑based capsule with a radiofrequency identification (RFID) tag and radiopaque barium designed to match PillCam dimensions and to disintegrate if retained, allowing assessment of small bowel patency prior to video capsule administration (AGILE received FDA marketing clearance in 2006).

Primary uses described in the policy include evaluation of obscure gastrointestinal bleeding (OGIB), suspected Crohn's disease, polyps, tumors, chronic inflammation, and iron deficiency anemia after prior negative upper endoscopy and colonoscopy; capsule endoscopy cannot obtain biopsies or provide therapy and carries a risk of retention in patients with strictures.

Prior Kaiser MTAC reviews (2001–2011) found variable evidence: early MTAC (2001) concluded insufficient evidence on health outcomes; subsequent MTAC reviews (2003, 2007) found higher diagnostic yield versus push enteroscopy for OGIB but limitations in outcome data; MTAC (2011) concluded limited evidence for the Agile patency capsule and that patency capsule use did not meet Kaiser Permanente assessment criteria for effectiveness.

Evidence	Summary
MTAC Evidence Conclusion (2001)
Insufficient published evidence on health outcomes for M2A capsule endoscopy (no studies of health outcomes; limited early reports and volunteer data).
MTAC Evidence Conclusion (2003)
Prospective comparative studies suggest higher diagnostic yield than push enteroscopy for unexplained GI bleeding; studies did not use gold standard so diagnostic accuracy not calculable.
MTAC Evidence Conclusion (2007)
Capsule endoscopy shows higher diagnostic yield in OGIB versus alternatives but evidence on impact on management and patient outcomes is insufficient; mixed results and need for randomized trials.
MTAC Evidence Conclusion (2011) - Patency Capsule
Limited evidence on Agile patency capsule usefulness and safety; case series suggest potential to identify patients who can safely undergo capsule endoscopy but evidence insufficient to meet effectiveness criteria.

Obscure Gastrointestinal Bleeding (OGIB): Bleeding of unknown origin that persists or recurs after negative initial upper and lower endoscopy; may be overt (visible bleeding) or occult (eg, iron deficiency anemia or positive fecal occult blood test).

Patency Capsule (AGILE Patency System): A dissolvable capsule with an RFID tag and radiopaque component, sized like the PillCam, designed to remain intact up to ~30 hours and to disintegrate if retained so fragments can be excreted; used to assess small bowel patency prior to administering a video capsule.

Document Type	Name	Number
LCD
Colon Capsule Endoscopy (CCE)
L38824
LCA
Billing and Coding: Colon Capsule Endoscopy (CCE)
A58436

OpenPayer

Capsule Endoscopy (including Patency Capsule / PillCam / PillCam SB / Colon Capsule)

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background & Evidence

Medicare Determinations

Revision History

91110	Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, with interpretation and report.
91111	Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with interpretation and report.
91113	Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report.