CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Transanal radiofrequency therapy (Secca) for fecal incontinence

Defines coverage stance for transanal radiofrequency therapy (Secca procedure) for treatment of fecal incontinence for Medicare Advantage and commercial products, including coding guidance and evidence summary. Notes benefits may vary by contract.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTransanal radiofrequency therapy (Secca) for fecal incontinence

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionVerify member-specific benefits and coverage under the Evidence of Coverage or Subscriber Agreement because benefits may vary between groups/contracts.

POLICY UPDATE CHANGES

No material changes to clinical evidence or coverage determinations.

Not coveredCoverage summary

8Nonrandomized studies cited

2002FDA 510(k) clearance year

Coverage Summary

Overview: This policy defines coverage for transanal radiofrequency therapy (Secca procedure) for treatment of fecal incontinence. The Secca System received FDA 510(k) clearance in 2002. Evidence includes 8 nonrandomized studies. Coverage stance: Not covered for Medicare Advantage; Not medically necessary for Commercial. Medicare Advantage plans note: transanal radiofrequency therapy is considered not covered due to insufficient evidence.

Medical Necessity / Coverage Determinations

Medicare Advantage Plans - Coverage Determination

Transanal radiofrequency therapy is considered not covered when used to treat fecal incontinence because evidence is insufficient to determine effects on health outcomes.

Procedure: Transanal (anal canal) radiofrequency energy delivery (Secca procedure) for fecal incontinence

Not covered due to insufficient evidence of clinical benefit

Commercial Plans - Coverage Determination

Transanal radiofrequency therapy is considered not medically necessary for treatment of fecal incontinence.

Procedure: Transanal radiofrequency therapy (Secca) for fecal incontinence

Not medically necessary due to insufficient evidence of clinical benefit

Provider Actions

Documentation Required

Benefits and contract variation

Verify member-specific benefits and coverage under the Evidence of Coverage or Subscriber Agreement because benefits may vary between groups/contracts.

Denial Risk

Claim denial / not covered service

Transanal radiofrequency therapy for fecal incontinence is considered not covered for Medicare Advantage and not medically necessary for commercial products; claims may be denied accordingly.

46999

Billing Rule

Coding guidance

Report the procedure with CPT 46999 (unlisted procedure, anus) as there is no specific CPT code for the Secca procedure.

46999

Background & Evidence Summary

Background: The Secca procedure delivers nonablative radiofrequency energy to the anal sphincter complex in an outpatient procedure (typically with conscious sedation) to create discrete thermal lesions that heal with tissue contraction and may change tissue tone to improve continence. The Secca System was cleared by the FDA in 2002 via the 510(k) process for general electrosurgical coagulation and specifically for fecal incontinence in patients with incontinence at least once per week who have failed conservative therapy. Benefits may vary by contract; refer to the Evidence of Coverage or Subscriber Agreement for applicable coverage rules.

Quality/quantity of clinical evidence8 nonrandomized studies; small sample sizes; imprecise estimates; variable and limited follow-up

Long-term outcomesSome small cohort 3-year follow-up showed decrement in response over time

Definition — Secca procedure: Transanal radiofrequency energy delivery to the anal sphincter complex intended to create thermal lesions that heal with tissue contraction to improve fecal continence.

Not Covered / Experimental Rationale

Rationale for noncoverage / not medically necessary: The procedure is considered not covered or not medically necessary because the evidence is insufficient to determine effects on health outcomes. Available data come from small, nonrandomized studies (totaling 8 studies) with imprecise estimates and variable, limited follow-up; a small cohort with 3-year follow-up showed decrement in response over time. Larger, longer, multicenter randomized controlled trials with adequate power are required to assess clinical benefit.