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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 03/01/2009 Title: Ankle Arthroplasty (Total Ankle Replacement)
Revision Date: 10/02/2013 Document: BI236:00
CPT Code(s): 27702, 27703
Public Statement

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.


Medical Statement

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:

27702

Reconstruct ankle joint

27703

Reconstruction ankle joint


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. Total ankle replacements have 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. Newer models have since been developed, which can be broadly subdivided into two design types, fixed bearing and mobile bearing.

1)    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 fixed-bearing devices are implanted with cement fixation (e.g., the Agility Ankle Revision; the Topez Total Ankle Replacement; the Eclipse Total Ankle Implant; the Inbone™ Total Ankle System; the Salto Talaris Total Ankle Prosthesis).

2)    Mobile-bearing systems have a polyethelene 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 (e.g., Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)) and have a porous coating on the components to encourage osseo-integration. The Buechel-Pappas device and the TNK ankle are additional mobile bearing devices, however they not approved for use by the FDA.

3)    Encouraged by the excellent results attained by total joint arthroplasty of the hip and knee, several surgeon-engineer teams designed and developed total joint prostheses for the ankle. In the early and middle 1970`s reports appeared of early success with these implants in 80% to 85% of patients. In 11 reports that included 346 arthroplasties, good or fair results were reported in 83% and failures in 17% at a mean follow-up of less than 5 years. A wave of enthusiasm developed for total ankle arthroplasty, and the indications for the procedure were expanded, often to include young people engaged in strenuous work or recreational activities. After further experience and longer periods of observation, reviews of most series of total ankle arthroplasties revealed extremely poor long-term results, especially in younger patients with isolated traumatic arthritis. In later reports in which the average follow-up was longer than 5 years, failure occurred in 35% to 76% of arthroplasties.

4)    Comparison of long-term series of total ankle arthroplasty are difficult because of variability in diagnosis, patient age, length of follow-up, prosthesis design, and absence of a uniform scoring system. The largest series of total ankle arthroplasties is that of Kitaoka et al. (1994, 1996), who reported their experience with 204 primary Mayo total ankle replacements. The overall cumulative rate of implant survival was 79% at 5 years, 65% at 10 years, and 61% at 15 years. The probability of an implant being in place at 10 years was 42% for patients 57 years of age or younger and who had previous operative treatment of the ipsilateral ankle or foot and 73% for those older than 57 years of age who had no such previous operative treatment. Because of these poor long-term results, they do not recommend the use of the Mayo total ankle arthroplasty, especially in younger patients who have had a previous operative procedure on the ipsilateral ankle or foot. In a series of 36 constrained Conaxial (Beck-Steffee) ankle replacements, Wynn and Wilde (1992) found that 27% were loose at 2 years, 60% at 5 years, and 90% at 10 years; they recommend that this ankle prosthesis not be implanted.

5)    Complications other than implant loosening also are more frequent after total ankle arthroplasty than after total hip or knee replacement. Delayed wound healing has been reported to occur in as many as 40% of patients, and most long-term series cite rates of deep infection of 3% to 5%. Loosening has been reported in 6% to 25% of implants after 3 to 5 years; usually the talar component is involved. Demottaz, et al. (1979) reported radiolucent zones of 2 mm or more at the cement-bone interface in 88% of prostheses at 1 year, and Unger et al. (1988) reported talar subsidence in 14 of 15 arthroplasties and tibial component tilting in 12 of 15 at an average 6-year follow-up. Wynn and Wilde (1992) reported an overall complication rate of 60%, including wound dehiscence (39%), deep wound infection (6%), fractures of the medial or lateral malleolus (22%), and painful talofibular impingement (14%).

6)    Although some more recent reports of uncemented, unconstrained replacements have shown better short-term results, currently no ankle implants are available that provide consistently good long-term results. There are no prospective randomized controlled clinical trials comparing total ankle replacement to fusion or other alternatives. In a review of total ankle arthroplasty, Saltzman (1999) concluded that despite efforts to develop a workable total ankle replacement the long-term results of most new designs are unknown. Saltzman concluded that prospective clinical trials are needed to determine which factors lead to successful and unsuccessful outcomes.

7)    In a review on total ankle replacement, Hintermann and Valderrabano (2003) stated that although the results of the different design approaches are encouraging in limited clinical series, there is still the need for careful, long-term analyses to estimate to what extent the current designs are mimicking the biomechanics of the ankle joint. More attention must be paid to more accurate implantation techniques that result in a well-balanced ligament and allow the ligaments to act together with the replaced surfaces in a most physiological manner. Gill (2004) noted that there is a need for further basic science research in total ankle arthroplasty. The lessons learned from other arthroplasty should be considered in ankle arthroplasty design.

8)    Van den Heuvel and colleagues (2010) stated that the ankle joint has unique anatomical, biomechanical and cartilaginous structural characteristics that allow the joint to withstand the very high mechanical stresses and strains over years. Any minor changes to any of these features predispose the joint to osteoarthritis. Total ankle replacement is evolving as an alternative to ankle arthrodesis for the treatment of end-stage ankle osteoarthritis. Initial implant designs from the early 1970s had unacceptably high failure and complication rates. As a result many orthopedic surgeons have restricted the use of TAR in favor of ankle arthrodesis. Long-term follow-up studies following ankle arthrodesis show risks of developing adjacent joint osteoarthritis. Thus, research towards a successful ankle replacement continues. Newer designs and longer-term outcome studies have renewed the interest in ankle joint replacement.


Reference

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.


Application to Products

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.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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