CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Transanal radiofrequency therapy (Secca) for fecal incontinence

This policy addresses coverage and clinical stance for transanal radiofrequency therapy (Secca procedure) as a treatment for fecal incontinence for BlueCHiP for Medicare and Commercial members of Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTransanal radiofrequency therapy (Secca) for fecal incontinence

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionConfirm member-specific benefits and eligibility by reviewing the Evidence of Coverage or Subscriber Agreement; benefits may vary by group/contract which could affect coverage of transanal radiofrequency therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance for BlueCHiP for Medicare

Not medically necessaryCoverage stance for Commercial

8Number of nonrandomized studies referenced

510(k) 2002FDA clearance of Secca System

Coverage Determination for Secca (Transanal Radiofrequency Therapy)

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Coverage determination

Transanal radiofrequency therapy (Secca) coverage determinations for fecal incontinence:

ALL of the following

BlueCHiP for Medicare: Transanal radiofrequency therapy is considered not covered as a treatment of fecal incontinence because the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial: Transanal radiofrequency therapy is considered not medically necessary as a treatment of fecal incontinence because the evidence is insufficient to determine the effects of the technology on health outcomes.

Benefits/contract variation note

Plan-specific considerations:

ANY of the following

Benefits may vary between groups/contracts; refer to Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits.

Actions for Providers and Billing Staff

Documentation Required

Benefit verification and subscriber agreement

Confirm member-specific benefits and eligibility by reviewing the Evidence of Coverage or Subscriber Agreement; benefits may vary by group/contract which could affect coverage of transanal radiofrequency therapy.

46999

Clinical and Evidence Summary

Transanal radiofrequency therapy using the Secca System delivers controlled radiofrequency energy to the anal sphincter complex via a transanal approach to create discrete thermal lesions intended to remodel tissue and improve fecal continence. In this outpatient procedure performed with conscious sedation, the thermal lesions heal over months, producing tissue contraction and changes in tissue tone that may improve continence.

The Secca System received U.S. Food and Drug Administration 510(k) clearance in 2002 for use in the electrosurgical coagulation of tissue, 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 therapy.

Available clinical evidence consists largely of small, nonrandomized studies (the policy references 8 nonrandomized studies). Study sample sizes are small, estimates of treatment effect are imprecise, follow-up durations vary and are limited, and some cohorts show decrement in response over time (for example at 3 years). Well-powered multicenter randomized controlled trials with adequate long-term follow-up are lacking; therefore the evidence is insufficient to determine the effects of the technology on health outcomes.

Defined Terms

Definitions

Secca procedureTransanal delivery of temperature-controlled radiofrequency energy to the anal canal sphincter complex intended to create thermal lesions and tissue remodeling to improve fecal continence.

Not medically necessary / Not coveredThe evidence is insufficient to determine that the therapy improves health outcomes; therefore the procedure is not covered under the respective product.

Scope & Related Information

Scope and policy status

Scope summaryThis policy addresses coverage and clinical stance for transanal radiofrequency therapy (Secca procedure) as a treatment for fecal incontinence for BlueCHiP for Medicare and Commercial members of Blue Cross Blue Shield - Rhode Island.

Coverage stanceBlueCHiP for Medicare: Not covered; Commercial: Not medically necessary (evidence is insufficient to determine effects on health outcomes).

Policy statusCURRENT

FDA clearance510(k) cleared (2002)

Number of nonrandomized studies8