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Flexible flatfoot is a common disorder, anatomically described as excessive pronation during weight bearing due to anterior and medial displacement of the talus. It may be congenital in nature, or may be acquired in adulthood due to posterior tibial tendon dysfunction, which in turn may be caused by trauma, overuse, and inflammatory disorders, among others. Symptoms include dull, aching and throbbing, cramping pain, which in children may be described as growing pains. Additional symptoms include refusal to participate in athletics or walking long distances. Conservative treatments include orthotics or shoe modifications. Surgical approaches for painful flatfoot deformities include tendon transfers, osteotomy, and arthrodesis. Arthroereisis with a variety of implant designs has also been investigated.
Arthroereisis (also referred to as arthroisis) is the limitation of movement across a joint. Subtalar arthroereisis (STA) 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 calcaneous.
Subtalar arthroereisis has been performed for more than 50 years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis (MBA) implant is the most frequently reported, although other devices such as the HyProCure, STA peg, and Kalix are also described in the medical literature. The MBA 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 MBA 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 received marketing clearance through FDA’s 510(k) process. For example, the HyProCure® Subtalar Implant System/Extra Osseos Fixation Device (GraMedica) received marketing clearance in 2004 (K042030), the SubFix™ arthroereisis implant (Memometal Technologies, Bruz, France) received FDA marketing clearance in 2010 (K093820) and the Arthrex ProStop Plus™ (Arthrex, Naples, FL) received marketing clearance in 2008 (K071456). The MBA® implant (now owned by Integra LifeSciences, Plainsboro, NJ) received 510(k) marketing clearance in 1996 (K960692) because it was substantially equivalent to products on the market prior to device regulation. According to the FDA summary, the primary indication for the Subtalar MBA device is “as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.” The MBAResorb Implant received 510(k) marketing clearance in 2005 (K051611). This implant employs the same basic mechanical features as the predicate MBA implant, but is composed of a material (poly l-lactic acid) that is resorbed by the body. Predicate devices include the Osteomed Talar-Fit™ (K031155), Nexa Orthopedics Subtalar Peg (K032902, K033046), Arthroereisis Implant Talus of Vilex (TOV, K041289), Instrateck (K080280), and Wright Medical Smith Sta-Peg (K792670).
POLICYSubtalar arthroereisis is considered investigational.
POLICY EXCEPTIONSFederal 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 GUIDELINESInvestigative 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
There is no specific CPT code for this procedure.
POLICY HISTORY05/18/2006: 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 added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.104
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.