Medical Policy

 

Subject: Total Ankle Replacement
Document #: SURG.00081 Publish Date:    06/28/2017
Status: Revised Last Review Date:    05/04/2017

Description/Scope

This document addresses total ankle replacement (arthroplasty) to replace a painful ankle joint. This procedure is indicated for pain due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.

Note: Please see the following related document for additional information:

Position Statement

Medically Necessary:

Total ankle replacement using a U.S. Food and Drug Administration  approved device* is considered medically necessary to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis when criteria in A, B, and C below are met:

  1. All of the following clinical features are present:
    1. Skeletally mature individual; and
    2. Ankle pain that significantly limits daily activity; and
    3. Completion and failure of at least 6 months of conservative treatment (such as anti-inflammatory medication, physical therapy, splints or orthotic devices as indicated);
      AND
  2. At least 1 of the following clinical conditions are present:
    1. Arthritis in adjacent joints (that is, subtalar or midfoot); or
    2. Arthrodesis of the contralateral ankle; or
    3. Inflammatory (for example, rheumatoid) arthritis; or
    4. Severe arthritis of the contralateral ankle;
      AND
  3. None of the following contraindications to total ankle replacement are present:
    1. Active ankle joint infection
    2. Charcot neuropathy
    3. Compromised bone stock or soft tissue
    4. Extensive avascular necrosis of the talar dome
    5. Malalignment (such as varus or valgus deformity greater than 15 degrees) not correctable by surgery
    6. Peripheral vascular disease

Revision or replacement of an implanted total ankle replacement is considered medically necessary, using a U.S. Food and Drug Administration  approved device*, when the implanted device has failed, and ALL of the criteria outlined above are met, EXCEPT criterion A3 regarding "Completion and failure of at least 6 months of conservative treatment." For replacement or revision, no prior treatment other than previous prosthetic implantation is required.

Investigational and Not Medically Necessary:

Total ankle replacement is considered investigational and not medically necessary when the above criteria are not met and for all other conditions.

*For U.S. Food and Drug Administration approved device, see Rationale section.

Rationale

Ankle arthrodesis (fusion) has been considered to be the preferred surgical procedure for the treatment of ankle arthritis. However, arthrodesis is not without its disadvantages and limitations. Arthrodesis can limit the motion of the ankle, thereby limiting mobility. During the recovery period following ankle arthrodesis, immobilization is usually required until there are signs of clinical and radiographic fusion (this can last 12 to 20 weeks). Some individuals develop a nonunion and require additional surgery. Adjacent joints may become painful due to the development of arthritis. In May 2009, the U.S. Food and Drug Administration (FDA) approved the Scandinavian Total Ankle Replacement (S.T.A.R.) System (Small Bone Innovations, Inc., Morrisville, PA-Small Bone Innovations, Inc. was acquired by Stryker in 2014). Although several other ankle systems have had FDA clearance through the 510(k) process, the S.T.A.R. System is the first approval of an ankle replacement system by the FDA. The researchers followed a group of 224 individuals in a clinical study and found that the ankle replacement system demonstrated similar rates of unfavorable events, surgical interventions and major complications as the alternative of fusion surgery (arthrodesis). With this approval of an ankle replacement system, improvement in prosthesis designs, and longer term outcome studies, total ankle replacement is now being considered as an alternative to ankle arthrodesis for the treatment of ankle arthritis.

Wood (2008) conducted a study of 200 total ankle replacements and reports on the medium-term results, 5 years postoperatively. Of the 200 ankles, 119 individuals had inflammatory arthritis and 81 individuals had osteoarthritis (25 were fracture-related). Using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hindfoot scoring tool to assess pain and function, the authors found that 135 ankles (67.5%) had good relief from pain. The 5-year survival rate of the prosthesis was 93.3% and the 10-year survival rate was 80.3%. Overall, 24 ankles failed at a mean of 48 months. Other complications included 5 ankles with delayed wound healing, 9 ankles had an intra-operative malleolar fracture and 10 ankles had a post-operative fracture within the first 12 months following total ankle replacement. The authors concluded that their survivorship figures were similar to those of early reports of total knee replacement when techniques and designs were being developed.

In order to help ensure the success of the total ankle replacement surgery, only certain individuals would be optimal candidates for this procedure. There is debate in the orthopedic community about what constitutes an optimal candidate for total ankle replacement surgery. Older, thin, sedentary individuals with minimal ankle deformity would be considered the optimal candidates. Some authors define older as greater than 50 years of age and thin as weighing less than 200 pounds. However, there is no clear consensus about what defines older, thin or sedentary. Due to the complexity of the ankle replacement procedure and potential for complications, individuals should have reached skeletal maturity, should have moderate or severe ankle pain, loss of mobility and function of the ankle and should have completion of at least 6 months of conservative treatment (Saltzman, 2009). Experience of the surgeon can also be a contributing factor to the success of a total ankle replacement. The overall incidence of adverse events and the need for subsequent surgeries has been reported to decrease with improved technique and greater surgeon experience (Saltzman, 2009).

In 2010, Slobogean and colleagues reported on quality of life 1 year post either ankle arthrodesis or total ankle replacement for end-stage ankle arthritis. A total of 107 individuals prospectively completed a Short-Form-36 (SF-36) generic health-related quality of life instrument and completed it again 1 year following either ankle arthrodesis or total ankle replacement. At baseline, there was no difference in the values between the two groups. At baseline, the health state value for the total ankle replacement group was 0.67 and for the arthrodesis group it was 0.66. At 1 year post surgery, the health state value for the total ankle replacement group was 0.73 and for the arthrodesis group was also 0.73. There was marked increase in both groups from baseline to 1 year post surgery; however, no significant difference between the two treatment groups. This study suggests that those individuals with end-stage ankle arthritis report lower quality of life and surgical treatment either by arthrodesis or ankle replacement may improve reported quality of life. This study is limited by the small number of participants and the inability to account for comorbidities which may affect the reported health state values. Further study is warranted.

In 2011, Zhao and colleagues reported on the outcomes and failure rates of the S.T.A.R. ankle replacement system. Reporting on a total of 16 studies which encompassed 2088 total ankle replacements and a mean follow-up time of 52 months, the 5-year pooled survival rate was 85.9% and the pooled 10-year survival rate was 71.1%. The mean failure rate of the S.T.A.R. implant was 11.1%. The three most common reasons for failure were aseptic loosening, malalignment, and infection. The authors concluded that an increase in surgeon experience and appropriate candidate selection could help to improve outcomes and decrease failure rate.

Malalignment of greater than 15 degrees has been considered to be a contraindication to total ankle replacement. A study by Queen and colleagues (2013) reported on the varying degrees of malalignment and compared the clinical outcomes and physical performance following total ankle replacement surgery. A total of 103 participants had total ankle replacement surgery; 17 of those participants were noted to have a malalignment of greater than 15 degrees preoperatively. Prior to surgery, participants had a clinician's assessment of function and also completed self-reported pain and function questionnaires. The participants completed the questionnaires again at 12 and 24 months following surgery. The authors report no significant differences in the clinical or functional outcomes on the basis of preoperative malalignment. The authors also note that the participants in their study were only followed for 2 years after ankle replacement surgery and "additional studies following patients for more than two years are necessary to understand the influence of preoperative alignment on the longevity of fixed-bearing total ankle implants."

A meta-analysis by Zaidi and colleagues (2013) looked at 58 studies involving 7942 total ankle replacement surgeries. The majority of the studies were level IV studies. The most commonly reported reason for total ankle replacement was post-traumatic arthritis followed by primary arthritis and rheumatoid arthritis. Overall 10-year survival rate of the implant was 89%. The authors reported intrinsic biases in all of the studies reviewed. But at 10 years postoperatively, the AOFAS and visual analog scores reported showed significant improvements.

A small (n=76) prospective study (Kraal, 2013) suggests that at 15 years follow-up, artificial joint survival remains relatively high, at 80% with sustained improvement in AOFAS scores (mean=80.4%, confidence interval [CI], 72-88). In this small cohort study, all devices were mobile-bearing in design and indication for replacement in all participants was inflammatory joint disease, potentially limiting generalizability of the findings.

Another small cohort study by Jastifer and colleagues (2014) published extended long-term data. Artificial joint survival in 18 participants who underwent revision with S.T.A.R. System was evaluated 10-15 years (mean 12.6 years) post-operation. Overall survival was high, at 94.4%, but 39% (n=7) of ankles required additional procedures (most were performed at 9 years or more). AOFAS scores improved from 32.8 preoperatively to 78 at the most recent follow-up and all participants rated their perceived outcome of total ankle replacement as good or excellent. Visual analog scores pain scores were reduced from a mean of 8.1 preoperatively to 2.1 at last follow-up. Although small, this study provides additional support for the longevity of total ankle replacement.

In a large cohort study, Daniels and colleagues (2014) compared intermediate-term results of total ankle replacement to arthrodesis. Of 388 ankles, 321 were available for follow-up at a mean of 5.5 years post-operation (n=232 replacements and n=89 arthrodesis). Authors found that despite higher rates of complication and reoperation rates in the total ankle replacement group, the primary outcomes of interest (Ankle Osteoarthritis Scale [AOS] and SF-36 scores) were equitable between the procedures. Authors highlight the potentially confounding aspect of this study that the arthrodesis group was younger, more likely to smoke and more likely to have diabetes. An additional short-coming was the lack of stratification by device type (six different total ankle replacement systems were used).

A novel prospective study by Jastifer and colleagues (2015) similarly evaluated the performance of total ankle replacement to arthrodesis; however, the focus of their investigation was performance on uneven surfaces, stairs and inclines. In total, 77 ankles received either total ankle replacement (n=61) or arthrodesis (n=16). Clinical and functional status of participants' ankles was evaluated preoperatively and postoperatively at 6 and 12 months. Both groups improved postoperatively from baseline, but the total ankle replacement group performed significantly better at walking up stairs (p=0.013), down stairs (p=0.012), and uphill (p=0.016). Furthermore the AOFAS scores, ankle dorsiflexion and ankle plantar flexion were also better in the total ankle replacement group (p=0.03, p<0.001, and p<0.001, respectively). This is the first study to investigate ankle joint performance of arthroplasty versus arthrodesis on uneven surfaces and stairs. Further investigation in large, diverse populations with long-term follow-up is warranted given the current recommendation that arthrodesis is more appropriate for younger, active individuals.

The American College of Foot and Ankle Surgeons® (ACFAS) updated their position statement on total ankle replacement surgery in July 2013 and they conclude that "total ankle replacement surgery is currently a safe and effective treatment option for select patients with end stage ankle arthritis. Studies have shown total ankle replacement surgery improves patient function, reduces pain, and promotes improved quality of life."

In 2014, the AOFAS released the following position statement: "The [AOFAS] endorses the use of total ankle replacement surgery for treatment of arthritic conditions of the ankle and does not consider this procedure to be experimental in select patients with this diagnosis who have failed nonoperative treatment."

Background/Overview

Total ankle replacement involves the surgical removal of a dysfunctional and painful ankle joint and its replacement with a prosthetic device. The purpose of a total ankle replacement is to relieve pain and restore joint function in individuals with medically refractory, end-stage degenerative joint disease resulting from conditions such as osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. 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. Total ankle replacement has been investigated since the 1970s, with initially promising results, but the procedure was essentially abandoned in the 1980s due to a high long-term failure rate, both in terms of pain control and improved function. However, researchers have continued to investigate new designs, which can be broadly subdivided into constrained and unconstrained designs. Constrained prostheses offer the advantage of greater stability, but with decreased mobility and increased stress at the bone implant interface, potentially leading to a greater risk of early loosening and failure. Unconstrained designs provide improved range of motion in multiple planes, but at the expense of stability. The first devices investigated were implanted with cement fixation, which in recent years has given way to cementless designs. The main alternative to total ankle replacement is arthrodesis which involves fusing the bones together completely restricting ankle motion. While both procedures are designed to reduce pain, the total ankle replacement is also intended to improve function.

The following outcomes are relevant to the analysis of safety and efficacy of total ankle replacement, compared to ankle arthrodesis, the standard treatment alternative:

For example, if an arthrodesis or ankle replacement is not properly aligned, significant gait abnormalities may result. In addition, an arthrodesis puts additional strain on proximal joints, which may in turn accelerate the development of arthritis in the knee and hip. The principal limitations of past total ankle replacements have been loosening of the prosthesis, requiring revision. If the prosthesis requires removal, the success of a subsequent arthrodesis must be considered. Different prostheses require different amounts of removal of bone stock, potentially compromising the success of a subsequent arthrodesis.

Definitions

Arthrodesis: The surgical fusion of a joint.

Arthroplasty: A procedure in which a joint is removed and replaced with a prosthesis.

Prosthesis: An artificial device to replace or augment a missing or impaired part of the body.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT  
27702 Arthroplasty, ankle; with implant (total ankle)
27703 Arthroplasty, ankle; revision, total ankle
   
ICD-10 Procedure  
0SRF0J9 Replacement of right ankle joint with synthetic substitute, cemented, open approach
0SRF0JA Replacement of right ankle joint with synthetic substitute, uncemented, open approach
0SRF0JZ Replacement of right ankle joint with synthetic substitute, open approach
0SRG0J9 Replacement of left ankle joint with synthetic substitute, cemented, open approach
0SRG0JA Replacement of left ankle joint with synthetic substitute, uncemented, open approach
0SRG0JZ Replacement of left ankle joint with synthetic substitute, open approach
0SWF0JZ-0SWFXJZ Revision of synthetic substitute in right ankle joint [by approach; includes codes 0SWF0JZ, 0SWF3JZ, 0SWF4JZ, 0SWFXJZ]
0SWG0JZ-0SWGXJZ Revision of synthetic substitute in left ankle joint [by approach; includes codes 0SWG0JZ, 0SWG3JZ, 0SWG4JZ, 0SWGXJZ]
   
ICD-10 Diagnosis  
M05.071-M05.079 Felty's syndrome, ankle and foot
M05.171-M05.179 Rheumatoid lung disease with rheumatoid arthritis of ankle and foot
M05.271-M05.279 Rheumatoid vasculitis with rheumatoid arthritis of ankle and foot
M05.371-M05.379 Rheumatoid heart disease with rheumatoid arthritis of ankle and foot
M05.471-M05.479 Rheumatoid myopathy with rheumatoid arthritis of ankle and foot
M05.571-M05.579 Rheumatoid polyneuropathy with rheumatoid arthritis of ankle and foot
M05.671-M05.679 Rheumatoid arthritis of ankle and foot with involvement of other organs and systems
M05.771-M05.779 Rheumatoid arthritis with rheumatoid factor of ankle and foot without organ or systems involvement
M05.871-M05.879 Other rheumatoid arthritis with rheumatoid factor of ankle and foot
M06.071-M06.079 Rheumatoid arthritis without rheumatoid factor, ankle and foot
M06.871-M06.879 Other specified rheumatoid arthritis, ankle and foot
M08.071-M08.079 Unspecified juvenile rheumatoid arthritis, ankle and foot
M08.271-M08.279 Juvenile rheumatoid arthritis with systemic onset, ankle and foot
M08.471-M08.479 Pauciarticular juvenile rheumatoid arthritis, ankle and foot
M08.871-M08.879 Other juvenile arthritis, ankle and foot
M08.971-M08.979 Juvenile arthritis, unspecified
M12.571-M12.579 Traumatic arthropathy, ankle and foot
M12.871-M12.879 Other specific arthropathies, not elsewhere classified, ankle and foot
M13.0 Polyarthritis, unspecified
M13.171-M13.179 Monoarhtritis, not elsewhere classified, ankle and foot
M13.871-M13.879 Other specified arthritis, ankle and foot
M15.0 Primary generalized (osteo)arthritis
M15.3 Secondary multiple arthritis
M19.071-M19.079 Primary osteoarthritis ankle and foot
M19.171-M19.179 Post-traumatic osteoarthritis, ankle and foot
M19.271-M19.279 Secondary osteoarthritis, ankle and foot
M25.571-M25.579 Pain in ankle
T84.018A-T84.018S Broken internal joint prosthesis [when specified as ankle]
T84.028A-T84.028S Dislocation of other internal joint prosthesis [when specified as ankle]
T84.038A-T84.038S Mechanical loosening of other internal prosthetic joint [when specified as ankle]
T84.068A-T84.068S Wear of articular bearing surface of internal prosthetic joint [when specified as ankle]
T84.098A-T84.098S Other mechanical complication of other internal joint prosthesis [when specified as ankle]
Z96.661-Z96.669 Presence of artificial ankle joint

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Anderson T, Montgomery F, Carlsson A. Uncemented STAR total ankle prosthesis. Three to eight-year follow-up of fifty-one consecutive ankles. J Bone Joint Surg Am. 2003; 85-A(7):1321-1329.
  2. Colman AB, Pomeroy GC. Transfibular ankle arthrodesis with rigid internal fixation: an assessment of outcome. Foot Ankle Int. 2007; 28(3):303-307.
  3. Conti SF, Wong YS. Complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):791-807, vii.
  4. 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; 96(2):135-142.
  5. Dyrby C, Chou LB, Andriacchi TP, Mann RA. Functional evaluation of the Scandinavian total ankle replacement. Foot Ankle Int. 2004; 25(6):377-381.
  6. Easley ME, Vertullo CJ, Urban WC, Nunley JA. Total ankle arthroplasty. J Am Acad Orthop Surg. 2002; 10(3):157-167.
  7. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004; 25(4):195-207.
  8. Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle Int. 2008; 29(2):256-264.
  9. Hintermann B, Valderrabano V. Total ankle replacement. Foot Ankle Clin. 2003; 8(2):375-405.
  10. Hopgood P, Kumar R, Wood PL. Ankle arthrodesis for failed total ankle replacement. 2006; 88(8):1032-1038.
  11. Jastifer JR, Coughlin MJ. Long-term follow-up of mobile bearing total ankle arthroplasty in the United States. Foot Ankle Int. 2015; 36(2):143-150.
  12. Jastifer J, Coughlin MJ, Hirose C. Performance of total ankle arthroplasty and ankle arthrodesis on uneven surfaces, stairs, and inclines: a prospective study. Foot Ankle Int. 2015; 36(1):11-17.
  13. Kotnis R, Pasapula C, Anwar F, et al. The management of failed ankle replacement. J Bone Joint Surg Br. 2006; 88(8):1039-1047.
  14. Kraal T, van der Heide HJ, van Poppel BJ, et al. Long-term follow-up of mobile-bearing total ankle replacement in patients with inflammatory joint disease. Bone Joint J. 2013; 95-B(12):1656-1661.
  15. Morse KR, Flemister AS, Baumhauer JF, DiGiovanni BF. Distraction arthroplasty. Foot Ankle Clin. 2007; 12(1):29-39.
  16. Queen RM, Adams SB Jr, Viens NA, et al. Differences in outcomes following total ankle replacement in patients with neutral alignment compared with tibiotalar joint malalignment. J Bone Joint Surg Am. 2013; 95(21):1927-1934.
  17. 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):579-596.
  18. Slobogean GP, Younger A, Apostle KL, et al. Preference-based quality of life of end-stage ankle arthritis treated with arthroplasty or arthrodesis. Foot Ankle Int. 2010; 31(7):563-566.
  19. Smith R, Wood PL. Arthrodesis of the ankle in the presence of a large deformity in the coronal plane. J Bone Joint Surg Br. 2007; 89(5):615-619.
  20. 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):2143-2149.
  21. Spirt AA, Assal M, Hansen ST Jr. Complications and failure after total ankle arthroplasty. J Bone Joint Surg Am. 2004; 86-A(6):1172-1178.
  22. Stamatis ED, Myerson MS. How to avoid specific complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):765-789.
  23. Stengel D, Bauwens K, Ekkernkamp A, Cramer J. Efficacy to total ankle replacement with meniscal-bearing devices: a systemic review and meta-analysis. Arch Orthop Trauma Surg. 2005; 125(2):109-119.
  24. Vickerstaff JA, Miles AW, Cunningham JL. A brief history of total ankle replacement and a review of the current status. Med Eng Phys. 2007; 29(10):1056-1064.
  25. Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003; 85(3):334-341.
  26. 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):605-609.
  27. Zaidi R, Cro S, Gurusamy K, et al. The outcome of total ankle replacement: a systematic review and meta-analysis. Bone Joint J. 2013; 95-B(11):1500-1507.
  28. Zhao H, Yang Y, Yu G, Zhou J. A systematic review of outcome and failure rate of uncemented Scandinavian total ankle replacement. Int Orthop. 2011; 35(12):1751-1758.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Foot and Ankle Surgeons. Position statement on total ankle replacement surgery. July 2013. Available at: http://www.acfas.org/Health-Policy-and-Advocacy/Policy-Statements/Position-Statements/. Accessed on March 20, 2017.
  2. American Orthopaedic Foot & Ankle Society® . Position statement on Total Ankle Replacement Surgery (2014). Available at: http://www.aofas.org/medical-community/health-policy/Documents/Total-Ankle-Replacement-Position-Statement-3-2014-FINAL.pdf. Accessed on March 20, 2017.
  3. STAR Total Ankle Replacement System [Product Information], Morrisville, PA. Small Bone Innovations. Updated on September 18, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050050c.pdf. Accessed on March 20, 2017.
  4. U.S. Food and Drug Administration Premarket Approvals. Scandinavian Total Ankle Replacement System (STAR Ankle). P050050. Rockville, MD: FDA. May 29, 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050050a.pdf. Accessed on March 20, 2017.
Websites for Additional Information
  1. National Institutes of Health (NIH), Medline Plus. Ankle Replacement. Updated on March 5, 2015. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007254.htm. Accessed on March 20, 2017.
Index

Agility® LP Total Ankle System
Ankle Arthroplasty
Ankle Replacement
INBONE® Total Ankle System
SALTO Talaris® Total Ankle Prosthesis
STAR Total Ankle Replacement System
Total Ankle Replacement
Zimmer® Trabecular Metal Total Ankle

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.  Minor typographical change in the Position Statement. Updated Rationale and Reference sections.
Revised 05/05/2016 MPTAC review. Updated References. Removed ICD-9 codes from Coding section.
Revised 05/07/2015 MPTAC review. Clarified medically necessary statement regarding revision or replacement of a previously implanted prosthesis. Updated References.
Reviewed 02/05/2015 MPTAC review. Updated Rationale and References sections.
Reviewed 02/13/2014 MPTAC review. Updated Rationale and References.
Revised 02/14/2013 MPTAC review. Clarification to Position Statement. Updated Rationale, References, and Index.
Revised 02/16/2012 MPTAC review. Clarification of Position Statement. Updated Rationale, Definitions, References and Index.
Reviewed 05/19/2011 MPTAC review. Updated Rationale, References and Index.
Revised 05/13/2010 MPTAC review. Addition to medically necessary statement about revision or replacement. Updated Coding and References.
Revised 11/19/2009 MPTAC review. Added medically necessary criteria for FDA approved device. Updated Rationale, Coding, References and Web Sites.
  06/03/2009 Updated Rationale to include FDA approval of total ankle replacement system.
Reviewed 11/20/2008 MPTAC review. References, Coding, Rationale and Background/Overview sections updated.
Reviewed 11/29/2007 MPTAC review. References, Rationale and Background/Overview sections updated. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
Reviewed 12/07/2006 MPTAC review. Rationale and References updated.
Reviewed 09/14/2006 MPTAC review. References updated.
Revised 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations Last Review Date Document Number Title
Anthem Southeast 11/08/2004 Memo 1179 Total Ankle Replacement
WellPoint Health Networks, Inc. 1/04/2004 3.01.13 Total Ankle Replacement