CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Subtalar Arthroereisis (Sinus Tarsi Implant) — Coverage Criteria

This policy governs coverage and medical necessity determinations for subtalar arthroereisis (extraosseous talotarsal stabilization / sinus tarsi implant) for treatment of flexible flatfoot and talotarsal joint dislocation for members of Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySubtalar Arthroereisis (Sinus Tarsi Implant) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for subtalar arthroereisis using codes 0335T or S2117; these are identified as not covered/not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance for subtalar arthroereisis

2 codesProcedure codes not covered

ObservationalEvidence

Removal policyRelated policy

Coverage Determination

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General coverage determination

Covered when ALL of the following are met

Overall coverage stance: Subtalar arthroereisis is considered not covered / not medically necessary because the evidence is insufficient to determine the effects on health outcomes.

Applies to treatment of flexible flatfoot and talotarsal joint dislocation based on available evidence.

Subtalar arthroereisis (also called extraosseous talotarsal stabilization or sinus tarsi implant) is not covered / not medically necessary for Commercial Products and is not covered for Medicare Advantage Plans. This determination applies to procedures reported with codes 0335T and S2117. The policy finds the available evidence insufficient to determine that subtalar arthroereisis improves net health outcomes, and claims for these procedures are subject to denial.

The rationale for deeming subtalar arthroereisis not medically necessary is based on limitations in the evidence base. Available data are primarily from single-arm observational studies, systematic reviews of observational data, and a single small nonrandomized comparative trial. Studies are limited by the frequent use of adjunctive procedures, which confounds attribution of outcomes to the implant alone, and by small sample sizes (for example, a comparative trial with N=24 feet).

Additional concerns include a lack of long-term outcome data—particularly important because the procedure is often performed in growing children—and reports of relatively high complication and implant removal rates. For talotarsal joint dislocation, evidence comes mainly from a prospective single-arm study; although some symptom and function improvements were observed, the evidence is insufficient to draw definitive conclusions about treatment efficacy or net health benefit.

Provider Requirements and Billing Impact

Prior Authorization

Prior authorization is not applicable for subtalar arthroereisis.

Denial Risk

Coverage Denial Triggers

Claims for subtalar arthroereisis (including insertion of sinus tarsi implant and arthroereisis, subtalar) are considered not covered / not medically necessary and are subject to denial.

Codes: 0335T, S2117
Not covered for Medicare Advantage Plans; not medically necessary for Commercial Products

Note

Benefit Verification and Member Eligibility

Providers should verify member benefits and eligibility prior to rendering services. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for coverage details and any applicable limitations.

Check group/contract-specific benefits for Medicare Advantage and Commercial Products
Contact the provider call center or refer to the member's plan documents for member-specific coverage

Documentation Required

Provider Action

If services are determined to be not medically necessary or non-covered, providers may not charge the member unless the member has been informed and has provided written agreement to pay. Refer to participation agreements for applicable provisions.

Do not bill members for denied services without prior written agreement
Policy information is for informational purposes and not a guarantee of payment

Clinical Background

Flexible (pediatric) flatfoot is a common disorder characterized by excessive pronation during weight-bearing due to anterior and medial displacement of the talus with associated calcaneal eversion. It may be congenital or acquired (for example, from posterior tibial tendon dysfunction). Symptoms can include activity-related aching or throbbing pain, refusal to participate in athletics or long walks, and functional limitations in children.

Subtalar arthroereisis is a surgical stabilization procedure intended to reduce pronation by placing an implant into the sinus tarsi (the canal between the talus and calcaneus) to limit subtalar joint motion and correct talar displacement and calcaneal eversion. Outcomes of interest include pain, function, and quality of life, but current studies do not provide sufficient high-quality, long-term evidence to establish net clinical benefit.

Definitions

Subtalar arthroereisis / extraosseous talotarsal stabilization — definition and mechanism

TermSubtalar arthroereisis (extraosseous talotarsal stabilization)

DefinitionA surgical procedure that places an implant in the sinus tarsi (the canal between the talus and the calcaneus) to limit subtalar joint motion and reduce excessive talar displacement and calcaneal eversion.

Mechanism of actionCorrection of excessive pronation by mechanically limiting motion across the subtalar joint via an extraosseous implant positioned in the sinus tarsi.

Indications described in policy backgroundEvaluated for treatment of flexible (pediatric) flatfoot and talotarsal joint dislocation.

Key evidence considerationsEvidence base consists mainly of single-arm observational studies, systematic reviews of observational data, and a small nonrandomized comparative trial; limitations include adjunctive procedures, short follow-up in growing children, and reported high complication and implant removal rates.