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Subtalar Arthroereisis

Policy Number: MP-357

Latest Review Date: April 2022

Category:  Surgery                                                               

POLICY:

Subtalar arthroereisis is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Arthroereisis is a surgical procedure that purposely limits 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 calcaneus.

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, subtalar arthroereisis 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.

KEY POINTS:

The most recent literature review was performed through January 17, 2022.

Summary of Evidence

For individuals who have flatfoot or talotarsal joint dislocation who receive STA, the evidence includes mainly single-arm case series and a small nonrandomized controlled trial comparing STA with lateral column calcaneal lengthening. The relevant outcomes are symptoms, functional outcomes, and quality of life. The small nonrandomized comparative trial (n=24 feet) is considered preliminary, and interpretation of the case series evidence is limited by the use of adjunctive procedures in addition to STA, creating difficulties in determining the extent to which each modality contributed to the outcomes. Another limitation of the published data is the lack of long-term outcomes, which is of particular importance because the procedure is often performed in growing children. Also, some studies have reported high rates of complications and implant removal. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have talotarsal joint dislocation who receive subtalar arthroereisis, the evidence consists of one prospective single-arm study of talotarsal stabilization using HyProCure. Relevant outcomes are symptoms, functional outcomes, and quality of life. Although improvements in pain and function were observed, the current evidence on the use of subtalar arthroereisis for treatment of talotarsal joint dislocation is insufficient to draw conclusions about treatment efficacy with certitude. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

Guidance from the National Institute for Health and Care Excellence (2009) concluded that current evidence on the safety and efficacy of sinus tarsi implant insertion for mobile flatfoot was inadequate in quality and quantity.

American College of Foot and Ankle Surgeons

The American College of Foot and Ankle Surgeons (ACFAS) published practice guidelines for the diagnosis and treatment of adult and pediatric flatfoot in 2004 and 2005 (these are not included in the ACFAS library of current clinical practice guidelines).

The ACFAS guidelines on adult flatfoot have stated:

“In the adult, arthroereisis is seldom implemented as an isolated procedure. Because of the long-term compensation and adaptation of the foot and adjunctive structures for flatfoot function, other ancillary procedures are usually used for appropriate stabilization. Long-term results of arthroereisis in the adult flexible flatfoot patient have not been established. Some surgeons advise against the subtalar arthroereisis procedure because of the risks associated with implantation of a foreign material, the potential need for further surgery to remove the implant, and the limited capacity of the implant to stabilize the medial column sag directly.”

The ACFAS guidelines on pediatric flatfoot have stated: “proponents of this procedure (arthroereisis) argue that it is a minimally invasive technique that does not distort the normal anatomy of the foot. Others have expressed concern about placing a permanent foreign body into a mobile segment of a child’s foot. The indication for this procedure remains controversial in the surgical community.”

Piraino et al (2020) published the following Clinical Consensus Statement on the appropriate clinical management of adult-acquired flatfoot deformity: "Subtalar arthroereisis should not be considered as a single corrective procedure for stage IIB AAFD [adult flatfoot]."

U.S. Preventive Services Task Force Recommendations

Not applicable.

Key Words:

Arthroereisis, Subtalar, MBA Implant, Subtalar Arthroereisis, HyProCure, peg, Kalix, Maxwell-Brancheau Arthroereisis (MBA)

APPROVED BY GOVERNING BODIES:

A number of implants have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, and are summarized in Table 1. In general, these devices are indicated for insertion into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation.

Table 1. Representative Subtalar Implant Devices Cleared by FDAa

Device

Manufacturer

Date Cleared

510(k) No.

Subtalar MBA®

Integra LifeSciences

07/96

K960692

OsteoMed Subtalar Implant System

OsteoMed

08/03

K031155

BioPro Subtalar Implant

BioPro

09/04

K041936

HyProCure Subtalar Implant System

Graham Medical Technologies

09/04

K042030

MBA resorb Implant

Kinetikos Medical

09/05

K051611

Metasurg Subtalar Implant

Metasurg

05/07

K070441

Subtalar Implant

Biomet Sports Medicine

07/07

K071498

Arthrex ProStop Plus Arthroereisis Subtalar Implant

Arthrex

01/08

K071456

Trilliant Surgical Subtalar Implant

Trilliant Surgical

02/11

K103183

Metasurg Subtalar Implant

Metasurg

08/11

K111265

NuGait™ Subtalar Implant System

Ascension Orthopedic

08/11

K111799

Disco Subtalar Implant

Trilliant Surgical

12/11

K111834

OsteoSpring FootJack Subtalar Implant System

OsteoSpring Medical

12/11

K112658

IFS Subtalar Implant

Internal Fixation Systems

12/11

K113399

The Life Spine Subtalar Implant System

Life Spine

06/16

K160169

FDA: Food and Drug Administration.

a FDA 510(k) database search product code HWC (03/08/18).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

For the insertion of the HyProCure® device use the following:

0335T

Extra-osseous subtalar joint implant for talotarsal stabilization

 

There are no specific CPT codes for this procedure or any of the other implants.  Physicians may use any of the following codes to file subtalar arthroereisis.

0510T

Removal of sinus tarsi implant

0511T

Removal and reinsertion of sinus tarsi implant 

28725

Arthrodesis, subtalar

28735

Arthrodesis, midtarsal or tarsometatarsal, multiple or transverse; with osteotomy (e.g., flatfoot correction)

28740

Arthrodesis, midtarsal or tarsometatarsal, single joint

29907

Arthroscopy, subtalar joint, surgical; with subtalar arthrodesis

28899

Unlisted procedure, foot or toes

 

HCPCS:

S2117

Arthroereisis, subtalar

 

REFERENCES:

  1. Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis implant. J Foot Ankle Surg 2012; 51(1):3-8.
  2. Bresnahan PJ, Chariton JT, Vedpathak A. Extraosseous talotarsal stabilization using HyProCure(R): preliminary clinical outcomes of a prospective case series. J Foot Ankle Surg. Mar-Apr 2013;52(2):195-202.
  3. 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.
  4. Cicchinelli LD, Pascual Huerta J, Garcia Carmona FJ et al. Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study. J Foot Ankle Surg 2008; 47(5):385-391.
  5. Cook EA, Cook JJ, Basile P. Identifying risk factors in subtalar arthroereisis explantation: a propensity-matched analysis. J Foot Ankle Surg 2011; 50(4):395-401.
  6. Graham ME, Jawrani NT, Chikka A. Extraosseous talotarsal stabilization using HyProCure(R) in adults: a 5-year retrospective follow-up. J Foot Ankle Surg 2012; 51(1):23-29.
  7. Harris EJ, Vanore JV, Thomas JL et al. Clinical Practice Guideline Pediatric Flatfoot Panel: American College of Foot and Ankle Surgeons (ACFAS). Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg 2004; 43(6):341-373.
  8. Lee MS, Vanore JV, Thomas JL et al. Clinical Practice Guideline Adult Flatfoot Panel: American College of Foot and Ankle Surgeons (ACFAS). Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg 2005; 44(2):78-113.
  9. Lucaccini C, Zambianchi N, Zanotti G. Distal osteotomy of the first metatarsal bone in association with sub-talar arthroerisis, for hallux valgus correction in abnormal pronation syndrome. Chir Organi Mov 2008; 92(3):145-148.
  10. 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; 32(12):1127-1139.
  11. National Institute for Clinical Excellence (NICE). Sinus Tarsi Implant Insertion for Mobile Flatfoot: Interventional Procedure Guidance 305. 2009; http://www.guidance.nice.org.uk/IPG305/Guidance/pdf/English.
  12. Needleman RL. A surgical approach for flexible flatfeet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int 2006; 27(1):9-18.
  13. Nelson SC, Haycock DM and Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg 2004; 43(3):144-155.
  14. Piraino JA, Theodoulou MH, Ortiz J, et al. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Appropriate Clinical Management of Adult-Acquired Flatfoot Deformity. J Foot Ankle Surg. Mar 2020; 59(2): 347-355. 
  15. Saxena A and Nguyen A. Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg 2007; 46(3):175-180.
  16. Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec 2010; 3(2):67-72.
  17. Scher DM, Bansal M, Handler-Matasar S et al. Extensive implant reaction in failed subtalar joint arthroereisis: report of two cases. HSS J 2007; 3(2):177-181.
  18. Vedantam R, Capelli AM and Schoenecker PL. Subtalar arthroereisis for the correction of planovalgus foot in children with neuromuscular disorders. J Pediatr Orthop 1998; 18(3):294-298.

POLICY HISTORY:

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Group, August 2009 (3)

Medical Policy Group, September 2010 (3)

Medical Policy Administration Committee October 2010

Available for Review October 21 through December 6, 2010

Medical Policy Group, September 2011(3): Updated Key Points and References

Medical Policy Group, October 2012 (3): 2012 Update to Key Points and References

Medical Policy Panel, September, 2013

Medical Policy Group, September, 2013 (3):  Updates to Description, Key Points, Approval by Governing Bodies; no change in policy statement

Medical Policy Group, December 2013 (1) 2014 Coding Update: added new code 0335T for the insertion of the HyProCure device, effective 01/01/2014

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Panel, September 2015

Medical Policy Group, October 2015 (2): 2015 Updates to Key Points, Current Coding, and References, no change in policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, August 2017 (7): Updates to Key Points. No change in Policy Statement.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (7): Updates to Key Points and Approved by Governing Bodies. No change in Policy Statement.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT codes 0510T and 0511T to the Current coding section.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points. No change in Policy Statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (7): Minor updates to Key Points. No new references added. No change in Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, May 2021 (7): Minor updates to Key Points. No new references added. Policy section updated to remove “not medically necessary” statement. No change in intent.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (7):  Updates to Key Points and References. Added Keywords “HyProCure, peg, Kalix, Maxwell-Brancheau Arthroereisis (MBA).” No change in policy statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.