CurrentBlue Cross Blue Shield - IowaPolicy N/A

Orally Ingested Transient Device for Constipation

Wellmark Blue Cross Blue Shield Iowa policy evaluating the use of the Vibrant System (orally ingested vibrating capsule) for treatment of adults with chronic idiopathic constipation (CIC); defines coverage stance, summarizes evidence, regulatory status, coding guidance, and policy history.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOrally Ingested Transient Device for Constipation

Policy CodePolicy N/A

Change TypeNew Policy

Effective DateOct 1, 2025

Next Review DateOct 1, 2025

Key ActionDocument diagnosis of chronic idiopathic constipation and prior standard therapies if coverage determination or appeals are pursued.

POLICY UPDATE CHANGES

New policy created in October 2025 establishing investigational status for orally ingested transient devices for constipation.

1Policy stance (investigational)

510(k) K232830FDA clearance reference

605Total participants across RCTs cited

4RCTs included in systematic review

Coverage Summary

This policy (02.01.83), effective October 1, 2025 and last reviewed on October 1, 2025, defines Wellmark Blue Cross Blue Shield Iowa's coverage position for the Vibrant System, an orally ingested vibrating capsule intended to treat adults with chronic idiopathic constipation (CIC). The document summarizes regulatory status, evidence, coding guidance, and policy history.

The policy purpose is to evaluate the Vibrant System for adults with CIC refractory to laxative therapy and, based on the evidence review, the overall coverage stance is that the technology is considered investigational / not covered (new policy created October 2025).

Key Statistics

Policy stanceInvestigational

FDA clearance reference510(k) K232830

Total participants across RCTs cited605

RCTs included in systematic review4

Coverage Determinations & Clinical Criteria

Coverage Determination

Policy statement:

Investigational statement: The use of an orally ingested transient device for the treatment of constipation is considered investigational
Evidence is insufficient to determine effects on net health outcomes

Policy reference: The use of an orally ingested transient device for the treatment of constipation is considered investigational because the evidence is insufficient to determine the effects of this technology on net health outcomes.

(Policy: investigational; evidence insufficient)

FDA Clearance / Indication (context only)

Device regulatory status (informational only):

Regulatory (informational): Vibrant System received 510(k) clearance on December 8, 2022 (K232830) for treatment of adults with chronic idiopathic constipation refractory to recommended-dose laxative therapy for at least one month

Included for context; does not imply coverage

Evidence & Background

The Vibrant System is an orally administered, battery-powered, drug-free capsule that mechanically stimulates the intestinal wall via programmed vibrations as it transits the gastrointestinal tract; capsules are activated prior to ingestion, begin vibrating in the large intestine at about 14 hours post-swallow in timed ~2-hour cycles, and are typically taken five days per week.

The device is intended for adults with CIC who have not achieved adequate relief with lifestyle measures and recommended-dose laxative therapy, positioned as an alternative after initial management with dietary and behavioral modifications and laxatives has failed.

Outcome / Study	Result
Phase 3 RCT (Rao 2023) primary endpoints after 8 weeks
CSBM ≥1/week: 39.3% vs 22.1% (p=0.001); CSBM ≥2/week: 22.7% vs 11.4% (p=0.008); rates of any adverse event 27% vs 17.4% (not statistically significant)

Definitions

Chronic Idiopathic Constipation (CIC)Functional gastrointestinal disorder with persistent difficult, infrequent, or incomplete bowel movements without an identifiable underlying structural, metabolic, or secondary cause.

Vibrant SystemAn FDA-cleared orally ingested vibrating capsule system designed to mechanically stimulate the colon to promote bowel movements; activated prior to ingestion, programmed to begin vibrating in the large intestine ~14 hours after swallowing in timed ~2-hour cycles; taken five days per week.

Coding Guidance

HCPCS Codes (device/programmer)HCPCS

A9268	Programmer for transient, orally ingested capsule.
A9269	Programmable, transient, orally ingested capsule, for use with external programmer, per month.

CPT CodesCPT

No specific CPT codes.

Place of Service / Type of Servicemixed

Outpatient	Place of Service = Outpatient
Medicine	Type of Service = Medicine

Provider Actions & Billing Impact

Documentation Required

Medical necessity documentation if requested

Although prior authorization is listed as Not applicable, providers should be prepared to document diagnosis of chronic idiopathic constipation and prior standard therapies if coverage determination or appeals are pursued.

Billing Rule

Use specified HCPCS codes for device billing

If reporting provider services related to the device, use HCPCS A9268 (programmer) and A9269 (programmable capsule per month) as appropriate; no specific CPT codes identified.

A9268
A9269

Denial Risk

Service considered investigational

Claims for orally ingested transient devices for constipation are likely to be denied as investigational per this policy.

Claims likely to be denied as investigational per this policy
A9268
A9269

Not Covered / Experimental Services

Policy decision: the use of an orally ingested transient device (e.g., the Vibrant System) for the treatment of constipation is considered investigational and therefore not covered by this policy.

Rationale: systematic reviews and randomized trials show mixed or limited findings (some short-term improvements in bowel movements but inconsistent effects on complete evacuation and limited durability beyond 8 weeks), and evidence is judged insufficient to determine an improvement in net health outcomes; because of this insufficiency, the technology does not meet coverage determination criteria.

Revision History

2025-10-01policy_creationLatest

Policy created and effective October 2025; labeled as New Policy in policy history. New policy created in October 2025 establishing investigational status for orally ingested transient devices for constipation.