Subject:
Total Ankle Replacement (Arthroplasty)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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A variety of total ankle replacement (TAR) system designs, including fixed-bearing and mobile-bearing, are being investigated for the management of moderate-to-severe tibiotalar pain. TAR (arthroplasty) is being evaluated as an alternative to tibiotalar fusion (arthrodesis) in patients with arthritis.
Background
The ankle joint is a comparatively small joint relative to the weight bearing and torque it must withstand. These factors have made the design of total ankle joint replacements technically challenging. The alternative to total ankle replacement (TAR) is arthrodesis, which may lead to alterations in gait and onset of arthrosis in joints adjacent to the fusion. While both procedures are designed to reduce pain, TAR is also intended to improve function and reduce stress on adjacent joints. TAR has been investigated since the 1970s, but in the 1980s the procedure was essentially abandoned due to a high long-term failure rate, both in terms of pain control and function. Newer models have since been developed, which can be broadly subdivided into 2 design types, fixed-bearing and mobile-bearing. More than 20 different ankle replacement systems are being evaluated worldwide.
Regulatory Status
Fixed-bearing designs lock the polyethylene component into the baseplate, which provides greater stability but increases constraint and edge-loading stress at the bone implant interface, potentially increasing risk of early loosening and failure. The first fixed-bearing devices were implanted with cement fixation (cement fixation requires more removal of bone). In 2002, the U.S. Food and Drug Administration (FDA) approved the Agility® Ankle Revision Prosthesis (DePuy Orthopaedics, Warsaw, IN), which is intended for cemented use only in patients with a failed previous ankle surgery. In 2005, FDA reviewed a 510(k) marketing clearance application for the Topez™ Total Ankle Replacement (Topez Orthopedics Inc., Boulder, CO) and determined that it was substantially equivalent to the existing DePuy Agility device. The Topez Ankle is now called the Inbone™ Total Ankle (Wright Medical Technology, Arlington, TN) and is also intended for cemented use only. The Agility LP (DePuy Orthopaedics) and the Eclipse (Kinetikos Medical, Carlsbad, CA) received 510(k) marketing clearance in 2006. The Salto Talaris® (Tornier, Edina, MN) received 510(k) marketing clearance in 2006 and 2009. These semi-constrained cemented prostheses are indicated in patients with end-stage ankle disorders (eg, affected with severe rheumatoid, posttraumatic, or degenerative arthritis) as an alternative to ankle fusion.
Three-piece mobile-bearing systems have a polyethylene component that is unattached and articulates independently with both the tibial and talar components. The 3-piece mobile-bearing prostheses are designed to reduce constraint and edge-loading but are less stable than fixed-bearing designs and have the potential for dislocation and increased wear of the polyethylene component. Mobile-bearing designs are intended for uncemented implantation and have a porous coating on the components to encourage osseointegration. They include the Ankle Evolution System (AES; Biomet, Whippany, NJ), Buechel-Pappas system, HINTEGRA® Total Ankle Prosthesis (New Deal), Mobility™ Total Ankle System (DePuy), Salto Total Ankle Prosthesis (Tornier), Scandinavian Total Ankle Replacement (STAR; Small Bone Innovations, Morrisville, PA), Bologna and Oxford Universities (BOX) Ankle (MAT Ortho), CCI Evolution Ankle (Van Straten), Zenith (Corin) and the TNK ankle (Kyocera Corp., Kyoto, Japan). Three-component mobile-bearing systems are Class III devices and are considered under a different regulatory pathway (premarket approval) than the fixed component devices described above, which were cleared for marketing under the 510(k) regulatory pathway. Premarket approval (PMA) requires demonstration of clinical efficacy in FDA-regulated trials conducted under an investigational device exemption (IDE). In May 2009, the FDA approved the STAR ankle as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis, or posttraumatic arthritis. As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next 8 years. The Mobility™ Total Ankle System is currently being evaluated in an FDA-regulated IDE trial. The AES, Buechel-Pappas, Mobility, Salto Total Ankle, BOX Ankle, CCI Evolution Ankle, Zenith and the TNK ankle are not currently used in the U.S.
Total ankle replacement has been performed in patients with severe rheumatoid arthritis, severe osteoarthritis, or posttraumatic osteoarthrosis.
Related Policy
- Subtalar Arthroereisis (Policy #076 in the Surgery Section)
Policy:
(NOTE: Effective December 3, 2018, Horizon Blue Cross Blue Shield of New Jersey (“Horizon BCBSNJ”) contracted with TurningPoint Healthcare Solutions, LLC (TurningPoint) to manage our Surgical and Implantable Device Management Program (“the Program”). TurningPoint conducts Prior Authorization and Medical Necessity Determination reviews of certain orthopedic services to be provided to members included in the scope of the Program. The scope of the program includes members enrolled in the Horizon BCBSNJ plans for the effective dates noted below.
For services rendered December 3, 2018 and after, the Program includes members enrolled in Horizon BCBSNJ Fully Insured plans.
For services rendered July 15, 2019 and after, the Program includes members enrolled in Horizon BCBSNJ Medicare Advantage plans.
For services to be rendered January 20, 2020 and after, the Program will also include members enrolled in New Jersey State Health Benefits Program (SHBP)/School Employees’ Health Benefits Program (SEHBP) plans.
Please note that this policy’s criteria and guidelines only apply to members enrolled in plans that DO NOT participate in the Program. Visit our TurningPoint webpage for instructions on accessing the policy criteria and guidelines that TurningPoint will follow as they conduct PA/MND reviews as part of the Program. You may also call TurningPoint at 1-833-436-4083, Monday through Friday between 8 a.m. and 5 p.m., Eastern Time to request policy content.)
For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Total ankle replacement using an FDA-approved device is considered medically necessary in skeletally mature members with moderate to severe ankle (tibiotalar) pain that limits daily activity, who have failed at least 6 months of conservative treatment including physical therapy, NSAIDs and orthoses as indicated, and who have the following conditions:
• Arthritis in adjacent joints (i.e., subtalar or midfoot); OR
• Severe arthritis of the contralateral ankle; OR
• Arthrodesis of the contralateral ankle; OR
• Inflammatory (e.g., rheumatoid) arthritis
2. Contraindications to total ankle replacement include, but are not limited to, the following conditions and thus, when present, total ankle replacement is not considered medically necessary:
• Extensive avascular necrosis of the talar dome;
• Compromised bone stock or soft tissue (including skin and muscle);
• Severe malalignment (e.g., > 15 degrees) not correctable by surgery;
• Active ankle joint infection;
• Peripheral vascular disease;
• Charcot neuroarthropathy:
• Peripheral neuropathy;
• Hindfoot or forefoot malalignment precluding plantigrade foot;
• Insufficient ligament support, irreparable with soft tissue stabilization;
• Neuromuscular disease resulting in lack of normal muscle function about the affected ankle;
• Prior fusion (conversion of fusion to arthrodesis);
• Cognitive/psychiatric issues that hinder adequate cooperation during perioperative period.
3. Total ankle replacement is considered investigational for all other indications.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Total Ankle Replacement
Total Ankle Arthroplasty
Ankle Replacement
Ankle Arthroplasty
TAR
References:
1. Coetzee JC, Deorio JK. Total ankle replacement systems available in the United States. Instr Course Lect 2010; 59:367-74.
2. Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle Int 2008; 29(2):256-64.
3. Haddad SL, Coetzee JC, Estok R et al. Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature. J Bone Joint Surg Am 2007; 89(9):1899-905.
4. SooHoo NF, Zingmond DS, Ko CY. Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty. J Bone Joint Surg Am 2007; 89(10):2143-9.
5. Krause FG, Windolf M, Bora B et al. Impact of complications in total ankle replacement and ankle arthrodesis analyzed with a validated outcome measurement. J Bone Joint Surg Am 2011; 93(9):830-9.
6. Schuh R, Hofstaetter J, Krismer M et al. Total ankle arthroplasty versus ankle arthrodesis. Comparison of sports, recreational activities and functional outcome. Int Orthop 2012; 36(6):1207-14.
7. Coester LM, Saltzman CL, Leupold J et al. Long-term results following ankle arthrodesis for post-traumatic arthritis. J Bone Joint Surg Am 2001; 83-A(2):219-28.
8. Buchner M, Sabo D. Ankle fusion attributable to posttraumatic arthrosis: a long-term followup of 48 patients. Clin Orthop Relat Res 2003; (406):155-64.
9. Takakura Y, Tanaka Y, Sugimoto K et al. Long-term results of arthrodesis for osteoarthritis of the ankle. Clin Orthop Relat Res 1999; (361):178-85.
10. Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res 2010; 468(1):199-208.
11. Roukis TS. Incidence of revision after primary implantation of the Agility total ankle replacement system: a systematic review. J Foot Ankle Surg 2012; 51(2):198-204.
12. Spirt AA, Assal M, Hansen ST, Jr. Complications and failure after total ankle arthroplasty. J Bone Joint Surg Am 2004; 86-A(6):1172-8.
13. Pyevich MT, Saltzman CL, Callaghan JJ et al. Total ankle arthroplasty: a unique design. Two to twelve-year follow-up. J Bone Joint Surg Am 1998; 80(10):1410-20.
14. Conti SF, Bisignani G, Martin R. Update on total ankle replacement. Semin Arthroplasty 1999; 10(2):62-71.
15. Kopp FJ, Patel MM, Deland JT et al. Total ankle arthroplasty with the Agility prosthesis: clinical and radiographic evaluation. Foot Ankle Int 2006; 27(2):97-103.
16. Glazebrook MA, Arsenault K, Dunbar M. Evidence-based classification of complications in total ankle arthroplasty. Foot Ankle Int 2009; 30(10):945-9.
17. Jensen NC, Linde F. Long-term follow-up on 33 TPR ankle joint replacements in 26 patients with rheumatoid arthritis. Foot Ankle Surg 2009; 15(3):123-6.
18. U.S. Food and Drug Administration. STAR Ankle Premarket Approval Panel Meeting Presentation 4-24-07. 2007. Available online at: http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4299s1-01.pdf. Last accessed July, 2013.
19. Saltzman CL, Mann RA, Ahrens JE et al. Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results. Foot Ankle Int 2009; 30(7):579-96.
20. Wood PL, Sutton C, Mishra V et al. A randomised, controlled trial of two mobile-bearing total ankle replacements. J Bone Joint Surg Br 2009; 91(1):69-74.
21. Zhao H, Yang Y, Yu G et al. A systematic review of outcome and failure rate of uncemented Scandinavian total ankle replacement. Int Orthop 2011; 35(12):1751-8.
22. Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br 2003; 85(3):334-41.
23. Wood PL, Prem H, Sutton C. Total ankle replacement: medium-term results in 200 Scandinavian total ankle replacements. J Bone Joint Surg Br 2008; 90(5):605-9.
24. Mann JA, Mann RA, Horton E. STAR Ankle: Long-Term Results. Foot Ankle Int 2011; 32(5):473-84.
25. Fevang BT, Lie SA, Havelin LI et al. 257 ankle arthroplasties performed in Norway between 1994 and 2005. Acta Orthop 2007; 78(5):575-83.
26. Nunley JA, Caputo AM, Easley ME et al. Intermediate to long-term outcomes of the STAR Total Ankle Replacement: the patient perspective. J Bone Joint Surg Am 2012; 94(1):43-8.
27. Henricson A, Nilsson JA, Carlsson A. 10-year survival of total ankle arthroplasties: a report on 780 cases from the Swedish Ankle Register. Acta Orthop 2011; 82(6):655-9.
28. Brunner S, Barg A, Knupp M et al. The Scandinavian total ankle replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventy-two consecutive patients. J Bone Joint Surg Am 2013; 95(8):711-8.
29. Kofoed H, Lundberg-Jensen A. Ankle arthroplasty in patients younger and older than 50 years: a prospective series with long-term follow-up. Foot Ankle Int 1999; 20(8):501-6.
30. Bonnin M, Gaudot F, Laurent JR et al. The Salto Total Ankle Arthroplasty: Survivorship and Analysis of Failures at 7 to 11 years. Clin Orthop Relat Res 2010; 469(1):225-36.
31. Giannini S, Romagnoli M, O'Connor JJ et al. Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles. J Foot Ankle Surg 2011; 50(6):641-7.
32. Wood PL, Karski MT, Watmough P. Total ankle replacement: the results of 100 mobility total ankle replacements. J Bone Joint Surg Br 2010; 92(7):958-62.
33. Rippstein PF, Huber M, Coetzee JC et al. Total ankle replacement with use of a new three-component implant. J Bone Joint Surg Am 2011; 93(15):1426-35.
34. Kokkonen A, Ikavalko M, Tiihonen R et al. High rate of osteolytic lesions in medium-term followup after the AES total ankle replacement. Foot Ankle Int 2011; 32(2):168-75.
35. Rodriguez D, Bevernage BD, Maldague P et al. Medium term follow-up of the AES ankle prosthesis: High rate of asymptomatic osteolysis. Foot Ankle Surg 2010; 16(2):54-60.
36. Buechel FF, Sr., Buechel FF, Jr., Pappas MJ. Ten-year evaluation of cementless Buechel-Pappas meniscal bearing total ankle replacement. Foot Ankle Int 2003; 24(6):462-72.
37. Buechel FF, Sr., Buechel FF, Jr., Pappas MJ. Twenty-year evaluation of cementless mobile-bearing total ankle replacements. Clin Orthop Relat Res 2004; (424):19-26.
38. Doets HC, Brand R, Nelissen RG. Total ankle arthroplasty in inflammatory joint disease with use of two mobile-bearing designs. J Bone Joint Surg Am 2006; 88(6):1272-84.
39. San Giovanni TP, Keblish DJ, Thomas WH et al. Eight-year results of a minimally constrained total ankle arthroplasty. Foot Ankle Int 2006; 27(6):418-26.
40. American Academy of Orthopaedic Surgeons (AAOS). Technology Overview. The surgical treatment of ankle arthritis. 2010. Available online at: http://www.aaos.org/research/overviews/AnkleArthritis_surgical.pdf. Last accessed July, 2013.
41. American College of Foot and Ankle Surgeons (ACFAS). 2010. Available online at: http://www.acfas.org/Physicians/Content.aspx?id=1933. Last accessed July, 2013.
42. American Orthopaedic Foot and Ankle Society (AOFAS). Position statement: Total ankle replacement surgery. 2009. Available online at: http://www.aofas.org/medical-community/health-policy/Documents/TAR_0809.pdf. Last accessed July, 2013.
43. National Institute for Health and Clinical Excellence (NICE). Total ankle replacement surgery. 2010. Available online at: http://guidance.nice.org.uk/IP/359. Last accessed July, 2013.
44. Zaidi R, Cro S, Gurusamy K et al. The outcome of total ankle replacement: a systematic review and meta-analysis. Bone Joint J. 2013 Nov;95-B(11):1500-7. doi: 10.1302/0301-620X.95B11.31633. Review.
45. Roselló Añón A, Martinez Garrido I, Cervera Deval J et al.Total ankle replacement in patients with end-stage ankle osteoarthritis: Clinical results and kinetic gait analysis. Foot Ankle Surg. 2014 Sep;20(3):195-200. doi: 10.1016/j.fas.2014.04.002. Epub 2014 Apr 18.
46. Queen RM, Sparling TL, Butler RJ et al. Patient-Reported Outcomes, Function, and Gait Mechanics After Fixed and Mobile-Bearing Total Ankle Replacement. J Bone Joint Surg Am. 2014 Jun 18;96(12):987-993. [Epub ahead of print]
47. Ramaskandhan JR, Kakwani R, Kometa S et al. MSTwo-year outcomes of MOBILITY Total Ankle Replacement. J Bone Joint Surg Am. 2014 Apr 2;96(7):e53. doi: 10.2106/JBJS.L.00536.
48. Daniels TR, Younger AS, Penner M et al. Intermediate-term results of total ankle replacement and ankle arthrodesis: a COFAS multicenter study. J Bone Joint Surg Am. 2014 Jan 15;96(2):135-42. doi: 10.2106/JBJS.L.01597.
49. Pugely AJ, Lu X, Amendola A et al. Trends in the use of total ankle replacement and ankle arthrodesis in the United States Medicare population. Foot Ankle Int. 2014 Mar;35(3):207-15. doi: 10.1177/1071100713511606. Epub 2013 Oct 31.
50. UpToDate. Total joint replacement for severe rheumatoid arthritis. Literature review current through July 2016. Topic last updated December 1, 2014.
51. Bloch B, Srinivasan S, Mangwani J. Current Concepts in the Management of Ankle Osteoarthritis: A Systematic Review. J Foot Ankle Surg. 2015 Sep-Oct;54(5):932-9.
52. Mulcahy H, Chew FS. Current Concepts in Total Ankle Replacement for Radiologists: Complications. AJR Am J Roentgenol 2015 Dec;205(6):1244-50.
53. Latham WC, Lau JT. Total Ankle Arthroplasty: An Overview of the Canadian Experience. Foot Ankle Clin 2016 Jun;21(2):267-81.
54. American Orthopaedic Foot and Ankle Society (AOFAS). Position statement: Total ankle replacement surgery. Available online at: https://www.aofas.org/medical-community/health-policy/Documents/Total-Ankle-Replacement-Position-Statement-3-2014-FINAL.pdf. Last accessed August 5, 2017.
55. Weisman MH, Rinaldi RZ. Total joint replacement for severe rheumatoid arthritis. In: UpToDate, Maini RN, Romian PL (Eds), UpToDate, Waltham, MA. (Accessed August 06/2017.)
56. Rinaldi RZ. Total joint replacement for severe rheumatoid arthritis. In: UpToDate, St Clair EW, Romian PL (Eds), UpToDate, Waltham, MA. (Accessed August 5, 2019.)
57. Rinaldi RZ. Total joint replacement for severe rheumatoid arthritis. In: UpToDate, St Clair EW, Romian PL (Eds), UpToDate, Waltham, MA. (Accessed July 23, 2020.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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