CurrentBlue Cross Blue Shield - IowaPolicy 07.01.34

Subtalar Arthroereisis

Wellmark Blue Cross and Blue Shield Iowa evidence review and policy determining coverage status for subtalar arthroereisis/extra‑osseous subtalar joint implants (sinus tarsi implants) for all indications; excludes subtalar arthrodesis (fusion). Policy addresses investigational determination, evidence summary, coding, and NA prior authorization.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySubtalar Arthroereisis

Policy CodePolicy 07.01.34

Change TypePolicy Renewed (Jul 2025); Revised (Jun 2023)

Effective DateDec 1, 2006

Next Review DateJul 1, 202625d

Key ActionVerify individual member benefits and contract exclusions; Wellmark determines medical necessity only if the benefit exists and no contract exclusions apply.

POLICY UPDATE CHANGES

Policy renewed at July 2025 annual review; policy was revised in June 2023 and previously revised multiple times.

InvestigationalCoverage status

FDA 510(k) cleared devicesRegulatory status

LimitedEvidence strength

Complication/removal rates ↑Reported adverse events

Coverage Summary

Wellmark Blue Cross and Blue Shield policy 07.01.34 addresses subtalar arthroereisis (sinus tarsi implants) and determines the procedure is investigational for all indications. The policy excludes subtalar arthrodesis (fusion) from its scope. Effective date: 2006-12-01; last review: 2025-07-01.

Policy metadata

Policy number07.01.34

SubjectSubtalar arthroereisis (sinus tarsi implant)

Coverage statusInvestigational for all indications

Effective date2006-12-01

Last review2025-07-01

Next review2026-07-01

Coverage status: Investigational for all indications. Regulatory status: multiple sinus tarsi implants have been cleared via FDA 510(k). Evidence strength: overall limited — principally single-arm studies, systematic reviews of observational data, and a small nonrandomized comparative trial, with methodological limitations and insufficient long-term data. Reported adverse events and implant removal rates vary widely across series, with unplanned removal and complication rates reported from low single digits up to approximately ~46% in some reports.

Policy Medical Necessity Determination

Policy coverage statement

Policy determination:

ALL of the following

Subtalar arthroereisis/extra-osseous subtalar joint implant is considered investigational for all indications because the evidence is insufficient to determine the technology results in an improvement in net health outcomes.
This evidence review addresses subtalar arthroereisis (implant in the sinus tarsi). Subtalar arthrodesis (joint fusion) is not addressed in this policy.

Provider Actions & Billing

Prior Authorization

Prior approval

Prior approval: Not applicable (policy states 'Prior Approval Not applicable').

Documentation Required

Benefit verification and medical necessity

Verify individual member benefits and contract exclusions; Wellmark determines medical necessity only if the benefit exists and no contract exclusions apply.

Verify member benefits and contract exclusions prior to services.

Billing Rule

Use appropriate procedure and diagnosis codes

Report appropriate CPT/HCPCS/Revenue/ICD codes for provider services; policy lists specific CPT and HCPCS codes for insertion/removal of sinus tarsi implants.

28899
0335T
0510T
0511T
S2117

Background & Evidence Summary

Subtalar arthroereisis places an implant into the sinus tarsi (canal between the talus and calcaneus) to limit subtalar joint pronation and correct talar displacement and calcaneal eversion. Multiple implant designs have been used for >50 years (for example, the Maxwell‑Brancheau implant, HyProCure, Kalix, subtalar peg), and devices vary in composition and insertion technique. The procedure is sometimes performed as a stand‑alone operation but frequently is combined with adjunctive bone or soft‑tissue procedures, and reported outcomes vary across studies and device types.

Study / Source	Key findings
Systematic review (Galan-Olleros 2024)
Improved pain in 93.5% (95% CI 89–97.99); heel valgus correction 95.21% (95% CI 91.14–99.28); overall complications 7.8% (Calcaneo-stop pooled; 20 studies, N=2394 feet)
Nonrandomized comparative trial (Chong 2015)
Prospective N=24 feet comparing arthroereisis vs lateral column lengthening: no between-group differences in clinical or functional outcomes at ~12.7 months; small sample, preliminary; 2 complications per group with some implant removals
Prospective single-arm (Bresnahan 2013)
HyProCure in talotarsal dislocation (46 feet): Maryland Foot Score improved from 69.53 to 89.17 at 1 year; foot pain decreased 37.0%; implants removed from 2 feet
Safety signal
Reports of implant reactions, sinus tarsi pain, implant migration, under/overcorrection, and implant removal; complication rates vary across series (examples: overall complications 7.8% in pooled Calcaneo-stop; other series report explantation/removal rates from ~7–39% and occasional rates up to 46%)
Health technology assessments
Hayes HTA (2020, updated 2023) rated evidence insufficient (D2) for adult-acquired flatfoot; pediatric HTA rated overall current evidence very low

Subtalar arthroereisis: Surgical procedure placing an implant in the sinus tarsi to limit subtalar joint motion and reduce excessive pronation; also called extraosseous talotarsal stabilization.

Talotarsal joint dislocation: Abnormal alignment of the talus with the heel and/or navicular bones.

Not Covered / Investigational

Policy determination: subtalar arthroereisis/extra‑osseous subtalar joint implants (sinus tarsi implants) are considered investigational for all indications because the evidence is insufficient to demonstrate an improvement in net health outcomes. Consequently, these implants are not covered. This policy explicitly does not address subtalar arthrodesis (joint fusion), which is excluded from this policy.

Safety and adverse events

Safety signalPublished reports of implant reactions, persistent sinus tarsi pain, implant migration/displacement, under/overcorrection

Complication/removal ratesOverall complication rates reported 4.8%–46% across series; unplanned implant removal/explantation reported ~7%–39% (series-dependent); pooled pediatric Calcaneo‑stop complications ~7.8%