Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Total ankle replacement (ankle arthroplasty) has limited coverage and requires pre-authorization.

2)    Total ankle replacement is a surgical procedure used to replace an ankle joint that has been severely damaged from either arthritis or trauma.

1)    Total ankle arthroplasty using an FDA-cleared implant is considered medically necessary in: Hayes C

a)    Skeletally mature persons and;

b)    Moderate to severe pain and;

c)    loss of ankle mobility and function due to osteoarthritis, post-traumatic arthritis and rheumatoid arthritis and;

d)    Who have failed at least 6 months of conservative management (including physical therapy, NSAIDs, and orthoses as indicated) and;

2)    Have none of the following conditions:

a)    Active or prior deep infection in the ankle joint or adjacent bones;

b)    Avascular necrosis of the talus;

c)    Charcot joint;

d)    Hindfoot or forefoot malalignment precluding plantigrade foot;

e)    Insufficient ligament support that cannot be repaired with soft tissue stabilization;

f)      Lower extremity vascular insufficiency;

g)    Neuromuscular disease resulting in lack of normal muscle function about the affected ankle;

h)    Peripheral neuropathy (may lead to Charcot joint of the affected ankle);

i)      Poor skin and soft tissue quality about the surgical site;

j)      Prior surgery or injury that has adversely affected ankle bone quality;

k)    Psychiatric problems that hinder adequate cooperation during perioperative period;

l)      Severe ankle deformity (e.g., severe varus or valgus deformity) that would not normally be eligible for ankle arthroplasty;

m)  Severe osteoporosis, osteopenia or other conditions resulting in poor bone quality, as this may result in inadequate bony fixation;

n)    Significant malalignment of the knee joint;

o)    Skeletal maturity not yet reached; or

p)    Weight greater than 250 lbs.

Codes Used In This BI:

1)    Arkansas BlueCross BlueShield, Coverage policy manual; Total Ankle Replacement. At: http://www.arkansasbluecross.com/members/report.aspx?policyNumber=2003028

2)    Hayes Inc, Medical Technology directory; total ankle replacement, Feb 2010

3)    Hintermann B, Valderrabano V. Total ankle replacement. Foot Ankle Clin. 2003; 8(2):375-405.

4)    Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004; 25(4):195-207.

5)    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.

6)    Haskell A, Mann RA. Ankle arthroplasty with preoperative coronal plane deformity: Short-term results. Clin Orthop. 2004 ;( 424):98-103.

7)    SooHoo NF, Zingmond DS, Ko CY. (2007) Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty. J Bone Joint Surg Am 2007; 89(10):2143-9.

8)    Spirit AA, Assal M, Hansen Jr ST. (2004) Complications, and failure after total ankle arthroplasty. J Bone Joint Surg 2004; 86-A: 1172-8.

9)    Stengel D, Bauwens K, et al. (2005) Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis. Arch Orthop Trauma Surg 2005; 125:109-19.

10) Valderrabano V, Hintermann B, Dick W. (2004) Scandinavian total ankle replacement: a 3.7-year average follow-up of 65 patients. Clin Orthop Relat Res 2004; 424:47-56.

11) Wood PL, Sutton C, Mishra V et al. (2009) A randomized, controlled trial of two mobile-bearing total ankle replacements. J Bone Joint Surg Br 2009; 91(1):69-74.

12) Wood PLR, Deakin S. (2003) Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br 2003; 85-B; 334-41.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.