Medical Policy: 07.01.34 
Original Effective Date: December 2006 
Reviewed: July 2016 
Revised: September 2014 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description:

Flatfoot (also known as pes planus) is often a complex disorder, with diverse symptoms and varying degrees of deformity and disability - with the common characteristic of partial or total collapse of the arch.  Flexible flatfoot is one of the most common types, anatomically described as excessive pronation during weight bearing due to anterior and medial displacement of the talus. (The term flexible means the foot is flat when standing (weight-bearing) and the arch returns when not standing.)  It may be congenital in nature, or may be acquired in adulthood due to posterior tibial tendon dysfunction.

 

Conservative treatments include orthotics or shoe modifications, stretching exercises and medication. Various surgical techniques of subtalar arthroereisis have been used in the treatment of patients who have failed conservative treatment.

 

Arthroereisis is the limitation of excessive movement across the joint. Subtalar arthroereisis is designed to correct the excessive talar displacement and calcaneal eversion by placing an implant in the sinus tarsi, a canal located between the talus and the calcaneus. Subtalar arthroereisis has been performed for a number of years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis (MBA) implant is currently favored due to the simple and reversible implantation procedure. The value of subtalar arthroereisis in the management and treatment of flatfoot deformity has not been established.

 

The HyProCure device (extra-osseous subtalar joint implant) from GraMedica is an implantable device indicated for the correction of talotarsal displacement. The device is inserted into the sinus tarsi and thereby reorientates the talocalcaneonavicular joint. The focus and primary diagnosis of the procedure is to properly realign and stabilize the talus of the tarsal mechanism, thereby restoring the talotarsal joint and talotarsal mechanism to normal function and triplane motion.

 

Other subtalar implants include:

  • Arthrex Prostop and Arthrex Prostop Plus Subtalar Arthroeresis Implant
  • Bioarch Subtalar Arthroereisis Implant
  • bioBLOCK Resorbable Subtalar Implant
  • BioPro Horizon Subtalar Implant
  • Futura Angled Subtalar Implant
  • Futura Conical Subtalar Implant
  • Kalix II
  • Lundeen Subtalar Implant
  • MetaSurg BioArch Subtalar Implant System
  • OsteoMed Talar-Fit Subtalar Implant System
  • Smith Subtalar Arthroereisis Implant
  • Sub-Talar Lok Arthroereisis Subtalar Implant System
  • Twist Subtalar Implant. 

2009 Guidance from the United Kingdom’s National Institute for Clinical Excellence concluded that current evidence on the safety and efficacy of sinus tarsi implant insertion for mobile flatfoot is inadequate in quality and quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit, or research.


Prior Approval:

 

Not applicable


Policy:

Subtalar arthroereisis is considered investigational. Data in the published medical literature are inadequate to permit scientific conclusions. One limitation of the published data is the lack of long-term outcomes, particularly important since the procedure is often performed in growing children. Another limitation is the lack of controlled studies comparing use of the implants with other surgical procedures (alone or in combination).

 

Currently there are not published control trials comparing talotarsal stabilization with extra-osseous subtalar joint implant and  nonsurgical treatment or alternative surgical techniques.  There are currently no randomized, prospective controlled studies that evaluate the safety and efficacy of subtalar arthroereisis in combination with other surgical procedures.  Limitations of the published data is the lack of longterm outcomes, particularly important since the procedure is often performed in growing children, and the difficulty in separating the effect of this procedure from that of other adjunctive treatments. In addition, some publications report high rates of complications and implant removal.  Extra-osseous subtalar joint implant is considered investigational.



Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • S2117 Arthroereisis, subtalar
  • 0335T Extra-osseous subtalar joint implant for talotarsal stabilization 

Selected References:

  • Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004;43(3):144-55. PubMed 15181430 [PMID].
  • Husain ZS, Fallat LM. Biomechanical analysis of Maxwell-Brancheau arthroereisis implants. J Foot ankle Surf. 2002 Nov-Dec;41(6):352-8.
  • Needleman RL. Current Topic Review: Subtalar Arthroereisis for the Correction of Flexible Flatfoot. Foot & Ankle Int. 2005 April;26(4):336-346.
  • Vora AN, Tien TR, Parks BG. Correction of moderate and severe acquired flexible flatfoot with medializing calcaneal osteotomy and flexor digitorum longus transfer. J Bone & Joint Sug. AM. 88:1726-1734, 2006.
  • Harris EJ, Vanore JV, Thomas JL, Kravitz SR, Mendelson SA, Mendicino RW, Silvani SH, Gassen SC; Clinical Practice Guideline Pediatric Flatfoot Panel. Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg. 2004. Nov-Dec;43(6):341-73.
  • Lee MS, Vanore JV, Thomas JL, Catanzariti AR, Kogler G, Kravitz SR, Miller SJ, Gassen SC. Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg 2005 Mar-Apr;44(2):78-113.
  • Needleman RL, A surgical approach for flexible flatfeet in adults including a subtalar arthroeresis with the MBA sinus tarsi implant. Foot Ankle Int. 2006 Jan;(1)9-18.
  • ECRI Institute. Subtalar Arthroereisis Implants for Treatment of Flexible Flatfoot Deformity. Plymouth Meeting (PA): ECRI Institute; 2006 Dec 28. 8p. [ECRI hotline response. Also available: http://www.ecri.org.
  • Saxena A, Nguyen A, Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroeresis. J Foot Ankle Surg. 2007 May-June;46(3)175-80.
  • National Institute for Health and Clinical Excellence (NICE). Sinus tarsi implant insertion for mobile flatfoot. Interventional Procedure Guidance 305. July 2009.
  • Metcalfe SA, Bowling FL, Reeves ND. Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int. 2011 Dec;21(12):1127-39.
  • ECRI. Subtalar Arthroereisis Implants for Treatment of Flexible Flatfoot. Plymouth Meeting (PA): ECRI InstituteExternal Site 2011 July 19. [Hotline Response].
  • Gross C, Erickson BJ, Adams SB, Parekh SG. Ankle arthrodesis after failed total ankle replacement: A systematic review of the literature. Foot Ankle Spec. 2015;8(2):143-151.
  • Chong DY, Macwilliams BA, Hennessey TA, et al. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. Jul 2015;24(4):345-353. PMID 25856275

Policy History:

  • July 2016 - Annual Review, Policy Renewed
  • August 2015 - Annual Review, Policy Renewed
  • September 2014 - Annual Review, Policy Revised
  • October 2013 - Interim Review, Policy Revised
  • May 2013 - Annual Review, Policy Renewed
  • May 2012 - Annual Review, Policy Renewed
  • June 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.