ModifiedKaiser PermanentePolicy N/A

Capsule endoscopy (small bowel and patency capsule) coverage criteria

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Clinical review criteria governing medical necessity determinations for capsule endoscopy (including PillCam/PillCam SB and Given/AGILE patency system) for Kaiser Permanente Washington members; guidance differs for Medicare vs non‑Medicare members.

Policy Summary

PayerKaiser Permanente

PolicyCapsule endoscopy (small bowel and patency capsule) coverage criteria

Policy CodePolicy N/A

Change TypeModified hybrid criteriacoding updates

Effective DateAug 1, 2024

Last ReviewMar 12, 2024

Next Review DateN/A

Key ActionVerify medical necessity and obtain prior authorization per plan type; submit recent labs and 12 months of clinical notes to support the request.

SourceLink

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ModifiedKaiser PermanentePolicy N/A

Capsule endoscopy (small bowel and patency capsule) coverage criteria

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Policy Summary

PayerKaiser Permanente

PolicyCapsule endoscopy (small bowel and patency capsule) coverage criteria

Policy CodePolicy N/A

Change TypeModified hybrid criteriacoding updates

Effective DateAug 1, 2024

Last ReviewMar 12, 2024

Next Review DateN/A

Key ActionVerify medical necessity and obtain prior authorization per plan type; submit recent labs and 12 months of clinical notes to support the request.

SourceLink

POLICY UPDATE CHANGES

MPC approved the modified hybrid criteria for capsule endoscopy effective August 1st, 2024, with a 60-day notice requirement.

Added Colon Capsule Endoscopy LCD/ILCA for Medicare.

Added applicable new CPT code to criteria and removed deleted CPT code.

5-10%OGIB proportion

1%capsule retention (overall)

5-13%retention in Crohn's

21%retention if obstruction suspected

56%patency excreted and proceeded

Medical Necessity & Coverage Criteria

Criteria source

Coverage determinations reference external criteria sources.

Criteria source selection: For Medicare members, applicable CMS/LCD guidance applies (for colon pathology use Colon Capsule Endoscopy LCD L38826). For non‑Medicare members, Kaiser Permanente Washington uses the MCG Capsule Endoscopy (KP-0134 08012024) criteria to determine medical necessity.

MCG criteria are proprietary and may be requested from Kaiser Permanente Clinical Review staff.

General coverage conditions

Covered when ALL of the following are met:

Indication and prior evaluation: Patient has an appropriate indication such as obscure gastrointestinal bleeding (OGIB) or suspected small‑bowel pathology (for example suspected Crohn's disease) after negative adequate upper endoscopy and colonoscopy, or other indications per applicable MCG/CMS criteria.

Safety and patency: There is no evidence of small‑bowel obstruction/stricture, OR luminal patency has been demonstrated prior to capsule administration (for example radiographic evaluation or a patency capsule/AGILE system where appropriate). Wireless capsule endoscopy is contraindicated in patients with suspected small bowel strictures.

Patency verification methods include SB follow‑through, CT enteroclysis, or patency capsule/RFID scanner as clinically indicated.

Documentation: Required supporting documentation is submitted with the request, including most recent relevant laboratory results and up to 12 months of clinical notes from the requesting provider or gastroenterology specialist to justify the indication and demonstrate prior evaluation and safety assessment.

Ensure documentation supports the specific MCG or CMS/LCD criteria used for the determination.

General coverage considerations

Covered when ALL of the following evidence‑based considerations are met (policy details and exact criteria located in the full MCG/CMS guidance):

Evidence and typical indications: Indication is typically OGIB or unexplained iron deficiency anemia after negative upper and lower endoscopy; capsule endoscopy has higher diagnostic yield versus several alternative diagnostic modalities but evidence of improved patient‑oriented outcomes is limited.

Multiple meta‑analyses and prospective studies inform diagnostic yield conclusions.

Retention risk and contraindications: Recognize risk of capsule retention (overall ~1% but higher in at‑risk groups; reported 5–13% in known Crohn's disease and up to 21% in suspected bowel obstruction). Capsule endoscopy is contraindicated in patients with intestinal blockage, strictures, fistulas, pregnancy, swallowing disorders, or certain implanted electromagnetic devices.

Retention may require endoscopic or surgical retrieval; weigh risks when considering testing.

Patency capsule performance and limitations: Patency (AGILE) capsule may be used to assess functional small bowel patency prior to video capsule administration, but published evidence on its usefulness and safety is limited and does not meet prior MTAC effectiveness criteria; intact excretion or non‑detection of the RFID at ~32–38 hours is generally considered evidence of patency in key series, though many capsules may be excreted after 38 hours.

Capsule endoscopy is contraindicated in patients with known or suspected intestinal blockage, strictures, or fistulas, in pregnant women, in patients with swallowing disorders, or in those with implanted electromagnetic devices such as cardiac pacemakers. The procedure carries a risk of capsule retention that may require endoscopic or surgical retrieval; documented retention rates are generally low (~1% overall) but substantially higher in at‑risk populations (for example, 5–13% with known Crohn’s disease and up to 21% in suspected bowel obstruction).

The policy does not support use of the M2A/Given Imaging capsule for routine evaluation of unexplained iron deficiency anemia because this application was judged by the Medical Technology Assessment reviews to not meet Kaiser Permanente Medical Technology Assessment criteria for effectiveness. In patients at risk for small‑bowel strictures, demonstrate luminal patency prior to capsule endoscopy — commonly by radiographic evaluation or with a patency capsule (AGILE Patency System) — but evidence supporting routine use of the patency capsule is limited.

Historical MTAC reviews concluded there is insufficient published evidence to support some specific uses of capsule endoscopy. For non‑Medicare members, Kaiser Permanente relies on proprietary MCG (KP‑0134) criteria for medical necessity determinations; when those proprietary MCG criteria are not met, the service may be considered not medically necessary per internal determinations.

Separate MTAC evidence reviews concluded that the AGILE patency capsule and the M2A (Given Imaging) capsule did not meet the Kaiser Permanente Medical Technology Assessment Criteria for effectiveness based on available published evidence. The patency capsule case series suggest it may identify some patients who can safely proceed to video capsule endoscopy, but randomized trials and direct comparisons to radiographic methods are lacking.

Devices & Billing Codes

Device names referencedmixed

MZA TM	Capsule endoscopy device name (Given/PillCam)
PillCam TM SB	Small bowel capsule endoscopy device
AGILE Patency System	Patency capsule and external scanner

(source listing)mixed

No codes listed

Applicable HCPCS/CPT CodesHCPCSCovered

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.

Patency capsule observation window — RFID/intact excretion timing details

Patency criteria (timing)RFID not detected or intact patency capsule excreted by 32–38 hours is considered evidence of luminal patency

Design-intended residence timeAgile patency capsule designed to remain intact for ~30 hours (first generation ~40 hours)

Late excretion noteMany patency capsules are excreted after the 38‑hour window; >25% in one series were excreted after 60 hours

Verification methodsPersistence can be verified by radiography or with an external radiofrequency detector locating the RFID

Clinical implicationIntact excretion or absent RFID at 32–38 hours supports proceeding with video capsule endoscopy to reduce retention risk

Authorization, Documentation & Operational Steps

Prior Authorization

Prior authorization and criteria source

For non‑Medicare members, KPWA applies the proprietary MCG Capsule Endoscopy (KP-0134 08012024) criteria for medical necessity determinations; for Medicare members use applicable CMS/LCD guidance for colon capsule endoscopy (eg, CCE LCD L38826) and KPWA clinical review criteria for non‑colon pathology. MCG criteria are proprietary and may be requested for individual utilization decisions by contacting Kaiser Permanente Clinical Review staff.

Non‑Medicare determinations: MCG Capsule Endoscopy (KP-0134 08012024).
Medicare determinations: follow applicable CMS/LCD (eg, Colon Capsule Endoscopy L38826) for colon pathology; KPWA criteria for other pathology.
MCG is proprietary; request a copy via Kaiser Permanente Clinical Review (1-800-289-1363).

Prior Authorization

Authorization required when medically necessary (HCPCS 91110/91111/91113)

Capsule endoscopy services billed with HCPCS/CPT codes 91110, 91111, or 91113 require that the medical necessity criteria in this policy are met and authorization requirements be verified by plan type using the Pre-authorization Code Check before scheduling.

Clinical Background & Evidence Summary

Obscure gastrointestinal bleeding (OGIB) accounts for about 5–10% of gastrointestinal bleeding and may present as overt bleeding or as occult iron deficiency anemia. Capsule endoscopy is a swallowable, battery‑powered video capsule that provides noninvasive visualization of the small bowel mucosa where conventional upper endoscopy and colonoscopy may not reach. It cannot obtain biopsies or provide therapy, and its principal procedural risk is capsule retention, particularly in patients with strictures or known Crohn’s disease.

Terms & Device Definitions

Capsule endoscopy (PillCam/MZA) — device definition and brief description

DefinitionCapsule endoscopy (e.g., PillCam/MZA): a swallowable, battery-powered disposable capsule containing a video camera, lights, transmitter and batteries that transmits images as it moves through the GI tract

Typical usePrimarily used to evaluate obscure gastrointestinal bleeding and suspected small-bowel pathology after negative upper and lower endoscopy

Recording durationProvides approximately five hours of continuous imaging captured on an external recorder

LimitationsNoninvasive visualization only — cannot obtain biopsies or perform therapy and carries risk of capsule retention in patients with strictures

Patency capsule (AGILE) — dissolvable capsule with RFID used to assess patency

Device description

Policy Changes & Effective Dates

2024-08-01operational_effective_dateLatest

MPC approved modified hybrid criteria for capsule endoscopy with an operational effective date of August 1, 2024 (60-day notice period).

2022-12-08coding_update

Added an applicable new CPT code to the criteria and removed a deleted CPT code.

2021-10-05medicare_coverage_addition

Policy Summary

PayerKaiser Permanente

PolicyCapsule endoscopy (small bowel and patency capsule) coverage criteria

Policy CodePolicy N/A

Change TypeModified hybrid criteriacoding updates

Effective DateAug 1, 2024

Last ReviewMar 12, 2024

Next Review DateN/A

Key ActionVerify medical necessity and obtain prior authorization per plan type; submit recent labs and 12 months of clinical notes to support the request.

SourceLink

On This Page

Passing the patency capsule intact in series (e.g., Herrerias 2008) allowed subsequent CE without retention, but trials comparing patency capsule to radiographic methods are lacking.

Decision logic and coverage stance: When MCG criteria (for non‑Medicare members) or applicable CMS/LCD guidance (for Medicare members) are met, capsule endoscopy is considered medically necessary; uses not supported by the evidence or not meeting proprietary MCG criteria may be considered not medically necessary.

Specific MCG criteria are proprietary and must be consulted for individual utilization decisions.

Verify authorization requirements for the specific code and plan using the Pre-authorization Code Check.
Services are considered medically necessary only when policy criteria are documented as met.

Step Therapy

Demonstrate luminal patency before capsule endoscopy

In patients at risk for small‑bowel strictures, demonstrate luminal patency before administering the diagnostic video capsule—commonly via the AGILE Patency Capsule (patency capsule) with external RFID detection or by radiographic small‑bowel evaluation.

AGILE Patency Capsule is designed to remain intact ~30 hours and can be verified by radiology or external RF detector; intact excretion indicates patency.
Radiographic techniques (SB follow‑through, enteroclysis, CT enteroclysis) are alternatives but may miss short stenoses.

Denial Risk

Do not perform CE when strictures suspected without patency evidence

Capsule endoscopy is contraindicated in patients with suspected small‑bowel strictures; do not proceed without documented patency. Failure to demonstrate patency or to address suspected strictures may lead to denial and exposes the patient to retention risk.

Contraindication: suspected small‑bowel strictures due to risk of capsule retention and possible obstruction.
If strictures are suspected, obtain patency evidence (patency capsule or radiographic) or manage stricture before CE.

Documentation Required

Required documentation to support medical necessity

Submit supporting clinical documentation with the authorization/claim: most recent laboratory results and the last 12 months of clinical notes from the requesting provider and/or gastroenterology specialist to establish medical necessity.

Include most recent lab work (eg, hemoglobin, iron studies when relevant).
Provide up to 12 months of clinical notes detailing prior endoscopic evaluations and indication for CE.

Billing Rule

Coding and documentation must support policy criteria

Use the applicable HCPCS/CPT codes (eg, 91110, 91111, 91113) when billing and ensure the clinical documentation clearly demonstrates that the policy criteria for medical necessity were met at the time of service.

Confirm codes are current and applicable; deleted or out‑of‑effect codes may not be covered.
Documentation must tie the chosen code to the clinical indication and policy criteria.

Denial Risk

Address retention/stricture risk before proceeding

Capsule retention risk is elevated in patients with known or suspected strictures (eg, Crohn’s disease, prior obstruction); if suspected strictures are not evaluated or patency is not demonstrated, the procedure is contraindicated and claims may be denied.

Reported retention rates: ~1% overall; 5–13% with known Crohn’s disease; up to 21% in suspected obstruction populations.
A retained capsule may require endoscopic or surgical retrieval and can cause obstruction or other complications.

Denial Risk

Denial risk for non‑supported indications or missing documentation

Claims for capsule endoscopy codes may be denied if the medical necessity criteria in this policy are not met or if required documentation (including patency evidence when indicated) is not submitted.

Denial risk if indication is not supported by documentation or if proprietary MCG criteria (for non‑Medicare members) are not met.
Verify plan‑specific authorization requirements and include requested supporting records to reduce denial risk.

AGILE Patency Capsule: a dissolvable capsule composed of a lactose body with 5% barium surrounding an RFID tag, coated with an impermeable membrane and sealed with wax timer plugs

PurposeDesigned to assess functional small-bowel patency prior to administering the diagnostic video capsule to reduce retention risk

Failure/disintegration behaviorIf passage is delayed beyond ~30 hours the capsule disintegrates (except the identification tag), allowing fragments to pass

Detection methodPresence or absence is determined by radiography or by scanning for the RFID with an external detector

OGIB — definition of obscure gastrointestinal bleeding

DefinitionObscure gastrointestinal bleeding (OGIB): bleeding of unknown origin that persists or recurs after negative initial upper endoscopy and colonoscopy; may be overt (visible bleeding) or occult (presenting as iron deficiency anemia)

PrevalenceAccounts for approximately 5–10% of all GI bleeds

Clinical challengeOGIB often arises from small lesions in the small bowel not accessible by standard endoscopy, frequently requiring additional diagnostic modalities

Diagnostic yield — definition and note on reporting in CE studies

DefinitionDiagnostic yield: the proportion of examinations that identify a lesion or finding

Literature noteMuch of the capsule endoscopy literature reports diagnostic yield rather than sensitivity and specificity due to lack of a consistent gold standard

Interpretation cautionHigher diagnostic yield indicates more lesions detected compared with alternative modalities but does not directly measure test sensitivity or false positives

Patency capsule (Agile/PillCam patency system) — dissolvable ingestible device used pre-CE to reduce retention risk

Device purposeAgile / PillCam Patency System: a dissolvable ingestible device used to assess small‑bowel patency before capsule endoscopy to reduce retention risk

Composition and featuresLactose body with barium for radiopacity, internal RFID tag, impermeable membrane, and wax timer plugs to control disintegration timing

Intended behaviorDesigned to remain intact for ~30 hours and to disintegrate if retained, permitting passage of fragments while leaving the RFID tag

Clinical roleUsed in patients at risk for small-bowel strictures to demonstrate luminal patency (via excretion or absent RFID) prior to administering the diagnostic video capsule

Added Colon Capsule Endoscopy LCD/ILCA reference for Medicare members.

2017-07-11indication_revision

MPC approved adoption of a revised indication for capsule endoscopy.

2016-08-31lcd_note_added

Added retired LCD language notation to the policy.

2015-05-05policy_modification

Minor policy modifications to include esophageal varices and allowance for approval of NSAIDs when aspirin is used for anticoagulation.