CurrentCignaPolicy 0576

Transanal radiofrequency therapy (SECCA) for fecal incontinence

This Cigna medical coverage policy addresses the use of transanal radiofrequency therapy (e.g., SECCA System) for treating fecal incontinence and applies to services submitted to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTransanal radiofrequency therapy (SECCA) for fecal incontinence

Policy CodePolicy 0576

Change TypeNo material change

Effective DateOct 15, 2024

Next Review DateOct 15, 2025

Key ActionDo not bill for transanal radiofrequency therapy for fecal incontinence as it is considered experimental/investigational and is not covered; claims using related codes (e.g., CPT 46999) are subject to denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

FDA 510(k) Class IIRegulatory status

46999Code

0576Policy ID

10/15/2025Next review

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Coverage Statement

Policy conclusion

Coverage stance: Transanal radiofrequency therapy (e.g., SECCA procedure) for fecal incontinence is considered experimental, investigational, or unproven.

Policy does not support coverage

Transanal radiofrequency therapy (e.g., the SECCA procedure) for the treatment of fecal incontinence is considered experimental, investigational, or unproven and is excluded from coverage under this policy. Services billed for this therapy (for example, using CPT 46999 — Unlisted procedure, anus) are identified as reporting an experimental or investigational service and are not covered.

Because this therapy is designated experimental, investigational, or unproven by the policy, there are no separate “not medically necessary” (NMN) condition listings applicable; the policy does not enumerate alternative NMN criteria for this service.

Provider Requirements and Billing Guidance

Prior Authorization

Prior authorization / coverage requirement: therapy not covered

Transanal radiofrequency therapy for fecal incontinence (e.g., SECCA procedure) is considered experimental, investigational, or unproven and therefore does not meet the policy's coverage criteria; claims for this therapy reported with related codes (for example, CPT 46999) are subject to denial consistent with the Coverage Policy.

Therapy is explicitly labeled experimental/investigational/unproven in the Coverage Policy.
Services billed with codes such as CPT 46999 for this therapy are identified as considered experimental/investigational.

Step Therapy

Prior conservative therapy context for candidate selection

The SECCA procedure is described as a proposed alternative for patients who have not responded to medical (conservative) therapy and who are not good surgical candidates or who have failed surgical intervention; however, despite this proposed use, the policy still deems the therapy experimental/investigational/unproven.

Intended for patients who have failed conservative measures or are poor surgical candidates.
Procedure is outpatient, takes ~30–45 minutes, and is performed under local anesthesia and sedation.

Billing Rule

Billing and documentation: use appropriate codes and expect denials for non-covered codes

When billing for services, providers must use the most appropriate procedure and diagnosis codes effective on the date of service; services not submitted with covered codes under this Coverage Policy will be denied as not covered.

Use current, appropriate CPT codes as of the submission date.
CPT 46999 (Unlisted procedure, anus) is listed in the policy as the code considered experimental/investigational when used to report transanal radiofrequency therapy.

Denial Risk

Denial triggers: claims subject to denial as not covered

Claims for transanal radiofrequency therapy that are not accompanied by covered procedure/diagnosis codes under this Coverage Policy will be denied as not covered; specifically, services reported with CPT 46999 for this therapy are identified as considered experimental/investigational and are subject to denial.

Submission with CPT 46999 for SECCA-related services is a denial trigger per the policy.
Reimbursement is not allowed for services billed for conditions or diagnoses not covered under this Coverage Policy.

Clinical Background

Fecal incontinence ranges from minor symptoms managed with diet modification, medications, and bowel-training to major incontinence that may require procedural or surgical intervention. Transanal radiofrequency therapy (SECCA) is a minimally invasive outpatient procedure intended to deliver controlled radiofrequency energy to the anal sphincter to induce collagen deposition and tissue remodeling, and it is typically offered for patients who have failed conservative therapies or are not good surgical candidates. Despite this clinical context, the policy concludes the therapy is experimental, investigational, or unproven and therefore not supported for coverage.

Definitions and Device Information

Transanal radiofrequency therapy (SECCA)

Procedure descriptionA minimally invasive transanal procedure that delivers controlled radiofrequency energy via an anoscopic probe to the anal sphincter, producing precise submucosal burn lesions intended to trigger collagen contraction and tissue remodeling to improve sphincter barrier function.

Device interfacePerformed using an anoscopic probe with multiple electrodes that deliver controlled radiofrequency energy to the sphincter muscles surrounding the anal canal.

Mechanism of actionEnergy creates submucosal lesions that are resorbed, leading to collagen deposition, contraction, and remodeling of tissue intended to improve continence.

Setting & durationTypically performed outpatient under local anesthesia and sedation; the procedure usually takes about 30–45 minutes.

Intended patient populationProposed for patients with fecal incontinence who have not responded to medical therapy and who are not good surgical candidates or have failed prior surgical intervention.

Secca System (Curon Medical)

Regulatory statusSecca System (Curon Medical Inc.) cleared by FDA as a 510(k) Class II device.

Cleared intended useCleared for general electrosurgical coagulation and specifically for treatment of fecal incontinence in patients with incontinence to solid or liquid stool at least once per week who have failed more conservative treatment.

ManufacturerCuron Medical Inc., Sunnyvale, CA.