Subtalar Arthroereisis

POLICY NUMBER

A.7.01.104

DESCRIPTION

Arthroereisis is a surgical procedure that purposely limits movement across a joint. Subtalar arthroereisis or extraosseous talotarsal stabilization is designed to correct excessive talar displacement and calcaneal eversion by reducing pronation across the subtalar joint. Extraosseous talotarsal stabilization is also being evaluated as a treatment of talotarsal joint dislocation. It is performed by placing an implant in the sinus tarsi, which is a canal located between the talus and the calcaneus.

Subtalar arthroereisis has been performed for more than 50 years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis implant is the most frequently reported, although other devices such as the HyProCure, subtalar arthroereisis peg, and Kalix are also described in the medical literature. The Maxwell-Brancheau Arthroereisis implant is described as reversible and easy to insert, with the additional advantage that it does not require bone cement. In children, insertion of the Maxwell-Brancheau Arthroereisis implant may be offered as a stand-alone procedure, although children and adults often require adjunctive surgical procedures on bone and soft tissue to correct additional deformities.

A number of implants have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, a sampling of which are summarized in the table below. In general, these devices are indicated for insertion into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation.

Representative Subtalar Implant Devices Cleared by the FDA^a

^a FDA 510(k) database search product code HWC

POLICY

Subtalar arthroereisis is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

05/18/2006: Approved by Medical Policy Advisory Committee (MPAC).

5/16/2007: Policy reviewed, MBAResorb Implant added to description.

5/21/08: Policy reviewed, no changes.

04/09/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Added the flat foot ICD-9 codes, 734 and 754.61.

10/21/2010: Policy reviewed; no changes.

10/05/2011: Policy reviewed; no changes.

11/30/2012: Policy reviewed; no changes.

11/15/2013: Policy reviewed; no changes.

11/12/2014: Policy reviewed; description updated. Policy statement unchanged.

08/27/2015: Code Reference section updated to add ICD-10 codes.

11/06/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.104 added.

09/13/2017: Policy description updated regarding arthroereisis and devices. Policy statement unchanged.

05/08/2018: Policy description updated regarding devices. Policy statement unchanged.

05/09/2019: Policy description revised. Policy statement unchanged.

05/27/2020: Policy reviewed; no changes.

07/23/2021: Policy reviewed; no changes.

05/26/2022: Policy reviewed; no changes.

05/10/2023: Policy description updated. Policy statement unchanged. Policy Guidelines updated.

05/14/2024: Policy description updated regarding devices. Policy statement unchanged.

05/07/2025: Policy description updated regarding devices. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.104

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.