Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.There are no NCDs and/or LCDs for extraosseous subtalar joint implantation and subtalar arthroereisis.

Extraosseous Subtalar Joint Implantation and Subtalar Arthroereisis

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Description

Subtalar arthroereisis is a surgical procedure that involves placing an implant that has the appearance of a threaded cylinder into the sinus tarsi between the talus bone and calcaneus (heel) to stabilize the foot. It may be performed on both children and adults for congenital and adult-onset flatfoot (eg, pes planus, pes planovalgus and pes valgus) deformities.

Examples of US Food & Drug Administration (FDA) approved implants utilized during subtalar arthroereisis include, but may not be limited to:

• Arthrex ProStop arthroereisis subtalar implant
• Gaitway implant system
• HyProCure subtalar implant systems
• OsteoMed Talar-Fit subtalar implant
• SubFix arthroereisis implant
• SubTalar Lok implant
• Subtalar Maxwell-Brancheau arthroereisis (MBA) system
• Trilliant Twist surgical subtalar implant

Talotarsal joint subluxation/ hypermobility occurs when the ankle bones have become displaced from their correct position on the hindfoot bones creating an imbalance or malalignment. Purportedly, this malalignment is a primary contributing cause to many foot and ankle problems including flatfoot. A subtalar joint implant (HyProCure) is used to correct subluxation during the extraosseous subtalar joint implantation or extraosseous talotarsal stabilization (EOTTS) surgical procedure.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

Extraosseous Subtalar Joint Implantation and Subtalar Arthroereisis

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US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage