CLINICAL POLICY

TOTAL ANKLE REPLACEMENT SURGERY (ARTHROPLASTY)

Policy Number: SURGERY 102.1 T2 Effective Date: April 1, 2012 Table of Contents CONDITIONS OF COVERAGE................................... DESCRIPTION OF SERVICE.. CLINICAL EVIDENCE................................................. POLICY AND RATIONALE................ TREATMENT/APPLICATION GUIDELINES............... PAYMENT GUIDELINES............................................. REFERENCES............................................................ POLICY HISTORY/REVISION INFORMATION.......... Policy History Revision Information Page 1 2 2 7 7 7 11 12 Related Policies: None

The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Members plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern.

CONDITIONS OF COVERAGE Applicable Lines of Business/Products This policy applies to Oxford Commercial plan membership General benefits package No Yes No

Benefit Type Referral Required

(Does not apply to non-gatekeeper products)

Authorization Required
(Precertification always required for inpatient admission)

Precertification with Medical Director Review Required Applicable Site(s) of Service

(If site of service is not listed, Medical Director review is required)

Inpatient, Outpatient

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

DESCRIPTION OF SERVICE/BACKGROUND INFORMATION The ankle joint is made up of 3 bones: the distal tibia, the talus and the distal fibula. The most common causes of degenerative ankle disease are rheumatoid arthritis (RA), primary osteoarthritis and post-traumatic arthritis. RA is a chronic, progressive and disabling autoimmune inflammatory disorder. Primary osteoarthritis of the ankle can occur in older individuals as part of the aging process. Post-traumatic or secondary osteoarthritis occurs as a complication following an ankle injury that does not heal properly. Conservative treatments for ankle arthritis include pain medications, weight loss, activity limitations, ankle braces, use of orthotics and physical therapy. When conservative methods of treatment fail and symptoms are severe or cause loss of function, surgery may be considered. Ankle arthrodesis (fusion), one surgical option, is effective in relieving pain but can limit ankle motion and impact gait. Total ankle replacement (TAR) is the replacement of a damaged ankle joint with an artificial joint. TAR aims to relieve pain without limiting the range of motion of the ankle or affecting other joints in the leg. Initial implant designs from the early 1970's had unacceptably high failure and complication rates and were largely abandoned. Newer designs require less bone removal and avoid the use of cement fixation. In addition, third- and fourth-generation implants are more compatible with the anatomy and biomechanics of the ankle. Contemporary prosthetic designs consist of 2 or 3 components. Two-piece metal designs are referred to as fixed-bearing systems, while three-piece designs are known as mobile-bearing systems. Mobile-bearing implants have a polyethylene bearing that floats between the two metal components. Most contemporary designs are uncemented, three-component, mobile-bearing implants (ECRI, 2010). CLINICAL EVIDENCE Intermediate- and long-term reports of the contemporary TAR systems showed good clinical outcomes with high patient satisfaction rates. However, the overall quality of the evidence was relatively weak and there was insufficient evidence to support conclusions about the outcomes of TAR compared with ankle fusion. Device-related complications were common, necessitating surgical revision or removal of the prosthesis. Revision rates were acceptable for the mobilebearing STAR, Buechel-Pappas and Hintegra designs, but considerable for the fixed-bearing Agility design. Definitive patient selection criteria for TAR have not been established (Hayes, 2010; updated 2011). The National Institute for Health and Clinical Excellence (NICE) considers total ankle replacement surgery standard clinical practice with an efficacy and safety profile that is sufficiently well known (NICE, 2010). Gougoulias et al. (2010) conducted a systematic review of studies reporting outcomes of total ankle arthroplasty. Thirteen studies reporting on 1105 total ankle arthroplasties (234 Agility, 344 STAR, 153 Buechel-Pappas, 152 HINTEGRA, 98 Salto, 70 TNK, 54 Mobility) were included. No randomized trials were identified. Residual pain was common (27%-60%), superficial wound complications occurred in 0% to 14.7% and deep infections occurred in 0% to 4.6% of ankles. Ankle function improved after total ankle arthroplasty in all studies reviewed. The overall failure rate was approximately 10% at 5 years with a wide range (0%-32%) between different centers. Superiority of one implant design over another was not supported by the available data. Haddad et al. (2007) conducted a systematic review and meta-analysis comparing the intermediate and long-term outcomes of total ankle arthroplasty versus ankle arthrodesis. The analysis of the outcomes focused on second-generation ankle implants. Forty-nine primary studies, ten of which evaluated total ankle arthroplasty in a total of 852 patients and thirty-nine of which evaluated ankle arthrodesis in a total of 1262 patients, were identified. The mean AOFAS (American Orthopaedic Foot and Ankle Society) Ankle-Hindfoot Scale score was 78.2 points for
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1996-2012, Oxford Health Plans, LLC

patients treated with total ankle arthroplasty and 75.6 points for those treated with arthrodesis. Meta-analytic mean results showed 38% of the patients treated with total ankle arthroplasty had an excellent result, 30.5% had a good result, 5.5% had a fair result and 24% had a poor result. In the arthrodesis group, the corresponding values were 31%, 37%, 13% and 13%. The five-year implant survival rate was 78% and the ten-year survival rate was 77%. The revision rate following total ankle arthroplasty was 7% with the primary reason for the revisions being loosening and/or subsidence (28%). The revision rate following ankle arthrodesis was 9% with the main reason for the revisions being nonunion (65%). One percent of the patients who had undergone total ankle arthroplasty required a below-the-knee amputation compared with 5% in the ankle arthrodesis group. The authors concluded that the intermediate outcomes of total ankle arthroplasty appear to be similar to that of ankle arthrodesis. Comparative studies are needed to strengthen this conclusion. Henricson et al. (2007) presented the results of a nationwide series of total ankle arthroplasties. All Swedish hospitals that implant or have implanted modern three-component ankle prostheses reported demographic data to a central register. Of the 531 prostheses implanted, 101 had been revised by June 15, 2006. The overall prosthesis survival rate at 5 years was 0.78. For the three surgeons who had inserted the majority of the STAR ankles, the survival rates became significantly higher after the first 30 cases had been performed and was estimated to be 0.86 at 5 years. Lower age at index surgery implied increased risk of revision whereas diagnosis or gender did not. The authors concluded that ankle replacement surgery is a valuable alternative to arthrodesis. However, replacing an ankle is a demanding procedure and results improve with increasing experience. Stengel et al. (2005) conducted a systematic review and meta-analysis of studies exploring the clinical results of three-component total ankle prostheses. Eighteen studies fulfilled the authors' eligibility criteria of at least 1 year of follow-up, a minimum sample size of 20 patients and a clinically relevant endpoint (e.g., ankle scores, range of motion, complications and survival rates). Formal data pooling was possible for 10 trials (n =497). The authors noted that there is some evidence that modern ankle arthroplasty is effective on patient-centered outcomes and may slightly improve the total range of motion. The cumulative infection and revision rates were tolerable, and secondary fusion rates were unexpectedly low. The weighted 5-year prosthesis survival rate averaged 90.6%. The authors concluded that ankle arthroplasty improves pain and joint mobility in end-stage ankle arthritis. The available literature suggests that ankle arthroplasty with meniscal-bearing implants provides an acceptable benefit-risk ratio. Its performance in comparison to the current reference standard (i.e., ankle fusion) remains to be defined in a properly designed randomized trial. Agility Claridge and Sagherian (2009) conducted a retrospective review of 28 total ankle arthroplasty procedures performed over a period of 5 years using the Agility Total Ankle Arthroplasty prosthesis. The American Orthopedic Foot and Ankle Society (AOFAS) questionnaire was used for evaluation. The mean AOFAS hindfoot score improved significantly from 34.9 to 76.4. Pain relief was the main factor in improving the score, followed by improved function. Complications varied from delayed wound healing, wound infection, painful hardware, iatrogenic malleolar fracture and arterial injury, to patients requiring free flap coverage. Despite the high rate of complications, which were successfully treated, most patients were satisfied at the last follow-up. The authors concluded that total ankle arthroplasty using the Agility Total Ankle prosthesis has clinically encouraging outcomes. However, the high complication rate should prompt surgeons to carefully select patients for this procedure. Kopp et al. (2006) retrospectively reviewed the results of total ankle arthroplasty using the Agility prosthesis in 41 consecutive patients (43 ankles). Evaluation included preoperative and postoperative questionnaires, physical examination and radiographs. At the time of follow-up, 38 patients (40 ankles) were available for review. The most common preoperative diagnoses included post-traumatic arthritis (n=24) and rheumatoid arthritis (n=8). Average follow-up was 44.5 months. Preoperative and postoperative AOFAS hindfoot scores averaged 33.6 and 83.3, respectively. Although 34 of 40 ankles demonstrated radiographic lucency or lysis, the degree of
Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

involvement varied. Migration or subsidence of components was noted in 18 ankles. Overall, 37 of 38 patients were satisfied with the outcome of their surgery and would have the same procedure under similar circumstances. The authors concluded that the Agility total ankle prosthesis results in a favorable clinical outcomes and patient satisfaction in most patients at intermediate-term follow-up. Scandinavian Total Ankle Replacement (STAR) Mann et al. (2011) conducted a prospective long-term study evaluating survivorship data in patients with the STAR Ankle prosthesis. Eighty-four total ankle replacements were performed in 80 patients using the STAR Ankle prosthesis. Patients were evaluated for pain and function, and serial radiographs were evaluated for stability and alignment of the prosthesis. Ninety-one percent of prostheses remained implanted at an average follow-up of 9.1 years. The probability of implant survival was 96% at 5 years and 90% at 10 years. The authors noted a statistically significant increase in both average pain and function scores. Ninety-two percent of the patients were satisfied with their outcome. Ten patients (13%) developed osteolytic lesions. The authors reported 21 complications, which included 14 additional surgical procedures. The authors found the STAR Ankle prosthesis to be an excellent long-term option for the treatment of ankle arthritis. Skytt et al. (2010) evaluated the survival of two ankle prosthesis designs and factors associated with survival using data from the nationwide arthroplasty registry in Finland. Of 645 operations, 573 were primary total ankle replacements (TAR) performed due to rheumatic, arthritic or posttraumatic ankle degeneration and 72 were revisions. The authors selected contemporary TAR designs that were each used in more than 40 operations. These included the STAR (n = 217) and AES (n = 298). The 5-year overall survivorship for the whole TAR cohort was 83%. The most frequent reasons for revision were aseptic loosening of one or both of the prosthesis components (39%) and instability (39%). The authors found no difference in survival rate between the STAR and AES designs. Furthermore, age, sex, diagnosis and hospital volume did not affect the TAR survival. Based on findings, the authors did not conclude that any one prosthesis was superior to another. Karantana et al. (2010) retrospectively reviewed 45 patients (52 ankles) who had primary total ankle replacements using the STAR prosthesis to assess survivorship. Prosthesis survival was 90% at 5 years and 84% at 8 years. Six of 52 ankles (11%) had component revision and two were converted to fusion. The mean postoperative AOFAS score was 78. The complication rate was 21%. Subsequent surgery, excluding component revision, was performed in nine of 52 (17%) ankles. Saltzman et al. (2009) performed a non-inferiority multicenter, prospective study comparing the safety and efficacy of the STAR ankle device with arthrodesis for treating end stage ankle arthritis. The Pivotal study groups included Scandinavian Total Ankle Replacement (STAR) patients (n=158 ankles) and a control group of ankle fusion patients (n=66 ankles). A second group of STAR total ankle patients (n=448), whose surgery was performed following the completion of enrollment in the Pivotal study, were also reported on as the Continued Access Group. At 24 months, success was defined as a 40-point improvement in total Buechel-Pappas ankle score, no device failures, revisions, or removals, radiographic success and no major complications. Major complications and the need for secondary surgical intervention were more common in the Pivotal study arthroplasty group than the Pivotal study ankle fusion group. In the Continued Access Group, secondary procedures performed on these arthroplasty patients decreased by half when compared with the Pivotal arthroplasty group. When the Pivotal groups were compared, treatment efficacy was higher for the ankle replacement group due to improvement in functional scores. Pain relief was equivalent between fusion and replacement patients. By 24 months, ankles treated with STAR ankle replacement (in both the Pivotal and Continued Access Groups) had better function and equivalent pain relief as ankles treated with fusion. Wood et al. (2009) reported the results of a randomized, prospective study of 200 ankle replacements comparing the Buechel-Pappas (BP) device (n=100) and the Scandinavian Total
Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

Ankle Replacement (STAR) implant (n=100). The two prostheses were similar in design consisting of three components with a meniscal polyethylene bearing. The minimum follow-up was 36 months with a mean follow-up of 54 months. Sixteen ankles (18%) failed (12 BP and 4 STAR), and of these, 14 ankles underwent fusion and 2 had revision surgery. At the time of review, there were 163 surviving replacements (75 BP and 88 STAR). The mean ankle score for pain and function improved similarly for the 2 groups. The range of motion did not get worse following surgery, but there was also no marked increase. The six-year survivorship of the BP design was 79% and the STAR 95%. The difference did not reach statistical significance. The authors noted that varus or valgus deformity prior to surgery did have a significant effect on survivorship in both groups, with the likelihood of revision being directly proportional to the size of the angular deformity. Forty-seven consecutive patients (49 ankles) treated for ankle arthritis with a Scandinavian total ankle replacement (STAR) were investigated retrospectively. Indications for surgery were endstage arthritis for rheumatoid arthritis (n=29), post-traumatic arthritis (n=12), osteoarthritis (n=5) and arthritis secondary to degenerative flatfoot (n=3). A modification of the Foot Function Index (FFI), which scores pain and task difficulties, was used for evaluation. Failure was defined as revision of the prosthesis or arthrodesis for any reason. At the time of follow-up, 45 prostheses survived, while four replacements had failed. The modified FFI ( 0 to 100, with a high score meaning more pain and disability) improved significantly from 59 before surgery to 35 after surgery. Radiological examination at follow-up showed radiolucent lines, osteolysis and malposition of the components in 31 cases. The authors noted that their results were comparable with those reported in the literature (Schutte and Louwerens, 2008). Salto Talaris Bonnin et al. (2011) analyzed long-term survival and postoperative function of the Salto mobilebearing prosthesis in a cohort of previously studied patients. The authors retrospectively reviewed 96 prospectively followed patients with 98 prostheses implanted between 1997 and 2000. Of those, 85 patients (87 prostheses) had a minimum follow-up of 6.8 years with a mean follow-up of 8.9 years. The survival rate was 65% with any reoperation of the ankle as the end point and 85% with revision of a component as the end point. Six prostheses were removed for arthrodesis, and 18 ankles underwent reoperation without arthrodesis. The authors observed three main causes of reoperations: bone cysts, fracture of the polyethylene and unexplained pain. They also noted that few patients experienced loosening and/or subsidence. The authors concluded that the data suggests a high rate of reoperations but only six revisions with arthrodesis with mid-term followup. Professional Societies American Academy of Orthopaedic Surgeons (AAOS) AAOS published a technology overview of surgical treatment options for patients with ankle arthritis in whom non-operative treatment has failed. The report concluded that based on low and very low quality evidence, treatment of ankle arthritis with either a generation 2 or generation 3 total ankle arthroplasty results in an improvement in pain and function. The literature does not conclusively demonstrate predictors of better or worse patient-oriented outcomes (e.g. device failure, reoperation, pain relief, patient satisfaction, walking ability) for total ankle arthroplasty. There is limited data from multiple studies directly comparing the efficacy of total ankle arthroplasty to arthrodesis in patients with arthritis. The disparate preoperative ankle function scores and demographic characteristics between the groups enrolled in the relevant comparative studies prohibits meaningful comparisons and confounds the interpretation of the data. Analysis of adverse events that corrected for preoperative differences in patients characteristics, provide conflicting results (AAOS, 2010). American College of Foot and Ankle Surgeons (ACFAS) An ACFAS position statement on total ankle replacement states that total ankle replacement surgery is currently a safe and effective treatment option for select patients with end-stage ankle arthritis. Studies have shown that total ankle replacement surgery improves patient function, reduces pain and promotes improved quality of life (ACFAS, 2010).
Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

American Orthopaedic Foot and Ankle Society (AOFAS) Over the past decade, total ankle replacement surgery has evolved as an acceptable and viable alternative to ankle arthrodesis in select patients with ankle arthritis. These include adult patients with primary, post-traumatic and rheumatoid arthritis who have moderate or severe pain, loss of mobility and loss of function of the involved ankle. Before considering total ankle replacement, patients should have completed several months of conservative treatment, should have satisfactory vascular perfusion in the involved extremity and must have adequate soft-tissue coverage about the ankle that affords a safe surgical approach to total ankle replacement. In such patients, high-level evidence indicates that total ankle replacement safely relieves pain and may provide superior functional results when compared to ankle fusion (AOFAS, 2009). U.S. Food and Drug Administration (FDA): Ankle prostheses are regulated by the FDA as Class II or Class III devices. Class III devices require a more stringent review process (premarket approval). See the following web site for more information (use product codes HSN for class II devices and NTG for class III devices). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed October 19, 2011. Mobile-bearing The Scandinavian Total Ankle Replacement System (STAR), manufactured by Small Bone Innovations, received PMA approval (P050050) from the FDA on May 27, 2009. The device is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. Fixed-bearing The Agility LP Total Ankle, manufactured by DePuy, received 510(k) approval (K053569) from the FDA on March 31, 2006. The device was approved as a line extension to the Agility Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The device is intended for use in patients with end stage ankle disorders as an alternative to ankle fusions. The INBONE Total Ankle (formerly the Topez Total Ankle), manufactured by Wright, received 510(k) approval (K103374) from the FDA on December 14, 2010. The devices is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. The INBONE II Total Ankle received 510(k) approval (K100886) on August 26, 2010. The Salto Talaris Total Ankle, manufactured by Tornier, received 510(k) approval (K060544) from the FDA on November 13, 2006. The device is indicated as a total ankle replacement device in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The Eclipse Total Ankle, manufactured by Integra Lifesciences, received 510(k) approval (K061749) from the FDA on November 22, 2006. The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement. Additional product information Buechel-Pappas (Endotec) - pulled from the U.S. market following FDA regulatory action stating that the device is subject to premarket approval Hintegra (Integra LifeSciences) - not approved in the U.S. AES (Biomet) - not approved in the U.S. Mobility (DePuy) - not approved in the U.S.

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

POLICY AND RATIONALE Oxford will cover total ankle replacement surgery (arthroplasty) as indicated in Treatment/Application Guidelines below. TREATMENT/APPLICATION GUIDELINES Total ankle replacement surgery (arthroplasty), using an FDA-approved device, is considered medically necessary for treating patients with the following conditions: Rheumatoid arthritis Osteoarthritis Post-traumatic arthritis

Information Pertaining to Medical Necessity Review Total ankle replacement surgery (arthroplasty), using an FDA-approved device, is medically necessary for treating patients with the following conditions: Rheumatoid arthritis Osteoarthritis Post-traumatic arthritis

when ALL of the following apply: Patient experiences moderate to severe ankle pain Patient experiences loss of ankle mobility and/or function Optimal medical management has been tried and failed Patient is skeletally mature

Note: Total ankle replacement is contraindicated in patients with active infection, osteonecrosis/avascular necrosis of the talus, insufficient blood supply in the involved ankle, Charcot neuropathy or other peripheral neuropathy, insufficient bone or soft tissue to ensure proper implant positioning or peripheral vascular disease. PAYMENT GUIDELINES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the Members plan of benefits or Certificate of Coverage. This list of codes may not be all inclusive. Applicable CPT Codes CPT Code 27700 27702 27703 Description Arthroplasty, ankle Arthroplasty, ankle; with implant (total ankle) Arthroplasty, ankle; revision, total ankle
CPT is a registered trademark of the American Medical Association.

Applicable ICD-9 Diagnosis Codes ICD-9 Code 714.0 714.1 714.2 Description Rheumatoid arthritis Felty's syndrome Other rheumatoid arthritis with visceral or systemic involvement 7

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

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714.30 714.31 714.32 714.33 714.4 715.17 715.27 715.37 715.87 715.97 716.17 716.57 716.67 716.87 716.97 719.47 996.40 996.41 996.42 996.43 996.44 996.45 996.46 996.47 996.49 V43.66

Polyarticular juvenile rheumatoid arthritis, chronic or unspecified Polyarticular juvenile rheumatoid arthritis, acute Pauciarticular juvenile rheumatoid arthritis Monoarticular juvenile rheumatoid arthritis Chronic postrheumatic arthropathy Primary localized osteoarthrosis, ankle and foot Secondary localized osteoarthrosis, ankle and foot Localized osteoarthrosis not specified whether primary or secondary, ankle and foot Osteoarthrosis involving, or with mention of more than one site, but not specified as generalized, ankle and foot Osteoarthrosis, unspecified whether generalized or localized, ankle and foot Traumatic arthropathy, ankle and foot Unspecified polyarthropathy or polyarthritis, ankle and foot Unspecified monoarthrtitis, ankle and foot Other specified arthropathy, ankle and foot Arthropathy, unspecified, ankle and foot Pain in joint, ankle and foot Unspecified mechanical complication of internal orthopedic device, implant, and graft Mechanical loosening of prosthetic joint Dislocation of prosthetic joint Broken prosthetic joint implant Peri-prosthetic fracture around prosthetic joint Peri-prosthetic osteolysis Articular bearing surface wear of prosthetic joint Other mechanical complication of prosthetic joint implant Other mechanical complication of other internal orthopedic device, implant, and graft Organ or tissue replaced by other means, ankle joint

ICD-10 Codes (Preview Draft) In preparation for the transition from ICD-9 to ICD-10 medical coding on October 1, 2014*, a sample listing of the ICD-10 CM and/or ICD-10 PCS codes associated with this policy has been provided below for your reference. This list of codes may not be all inclusive and will be updated to reflect any applicable revisions to the ICD-10 code set and/or clinical guidelines outlined in this policy. *The effective date for ICD-10 code set implementation is subject to change. ICD-10 Diagnosis Code (Effective 10/01/14) M05.071 M05.072 M05.079 M05.271 M05.272 M05.279 M05.371 M05.372 M05.379 M05.471 M05.472 M05.479

Description

Felty's syndrome, right ankle and foot Felty's syndrome, left ankle and foot Felty's syndrome, unspecified ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot 8

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

M05.571 M05.572 M05.579 M05.671 M05.672 M05.679 M05.771 M05.772 M05.779 M05.871 M05.872 M05.879 M06.071 M06.072 M06.079 M06.1 M06.271 M06.272 M06.279 M06.371 M06.372 M06.379 M06.871 M06.872 M06.879 M07.671 M07.672 M07.679 M08.071 M08.072 M08.079 M08.271 M08.272 M08.279 M08.3 M08.471 M08.472 M08.479 M08.871 M08.872 M08.879 M08.971 M08.972 M08.979 M12.071 M12.072 M12.079 M12.571 M12.572

Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement Other rheumatoid arthritis with rheumatoid factor of right ankle and foot Other rheumatoid arthritis with rheumatoid factor of left ankle and foot Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot Rheumatoid arthritis without rheumatoid factor, right ankle and foot Rheumatoid arthritis without rheumatoid factor, left ankle and foot Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot Adult-onset Still's disease Rheumatoid bursitis, right ankle and foot Rheumatoid bursitis, left ankle and foot Rheumatoid bursitis, unspecified ankle and foot Rheumatoid nodule, right ankle and foot Rheumatoid nodule, left ankle and foot Rheumatoid nodule, unspecified ankle and foot Other specified rheumatoid arthritis, right ankle and foot Other specified rheumatoid arthritis, left ankle and foot Other specified rheumatoid arthritis, unspecified ankle and foot Enteropathic arthropathies, right ankle and foot Enteropathic arthropathies, left ankle and foot Enteropathic arthropathies, unspecified ankle and foot Unspecified juvenile rheumatoid arthritis, right ankle and foot Unspecified juvenile rheumatoid arthritis, left ankle and foot Unspecified juvenile rheumatoid arthritis, unspecified ankle and foot Juvenile rheumatoid arthritis with systemic onset, right ankle and foot Juvenile rheumatoid arthritis with systemic onset, left ankle and foot Juvenile rheumatoid arthritis with systemic onset, unspecified ankle and foot Juvenile rheumatoid polyarthritis (seronegative) Pauciarticular juvenile rheumatoid arthritis, right ankle and foot Pauciarticular juvenile rheumatoid arthritis, left ankle and foot Pauciarticular juvenile rheumatoid arthritis, unspecified ankle and foot Other juvenile arthritis, right ankle and foot Other juvenile arthritis, left ankle and foot Other juvenile arthritis, unspecified ankle and foot Juvenile arthritis, unspecified, right ankle and foot Juvenile arthritis, unspecified, left ankle and foot Juvenile arthritis, unspecified, unspecified ankle and foot Chronic postrheumatic arthropathy [Jaccoud], right ankle and foot Chronic postrheumatic arthropathy [Jaccoud], left ankle and foot Chronic postrheumatic arthropathy [Jaccoud], unspecified ankle and foot Traumatic arthropathy, right ankle and foot Traumatic arthropathy, left ankle and foot 9

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

1996-2012, Oxford Health Plans, LLC

M12.579 M12.871 M12.872 M12.879 M13.0 M13.171 M13.172 M13.179 M19.071 M19.072 M19.079 M19.171 M19.172 M19.179 M19.271 M19.272 M19.279 M25.571 M25.572 M25.579 M96.671 M96.672 M96.679 T84.068A T84.116A T84.117A T84.126A T84.127A T84.129A T84.196A T84.197A T84.318A T84.328A T84.398A T84.418A T84.428A T84.498A Z96.661 Z96.662

Traumatic arthropathy, unspecified ankle and foot Other specific arthropathies, not elsewhere classified, right ankle and foot Other specific arthropathies, not elsewhere classified, left ankle and foot Other specific arthropathies, not elsewhere classified, unspecified ankle and foot Polyarthritis, unspecified Monoarthritis, not elsewhere classified, right ankle and foot Monoarthritis, not elsewhere classified, left ankle and foot Monoarthritis, not elsewhere classified, unspecified ankle and foot Primary osteoarthritis, right ankle and foot Primary osteoarthritis, left ankle and foot Primary osteoarthritis, unspecified ankle and foot Post-traumatic osteoarthritis, right ankle and foot Post-traumatic osteoarthritis, left ankle and foot Post-traumatic osteoarthritis, unspecified ankle and foot Secondary osteoarthritis, right ankle and foot Secondary osteoarthritis, left ankle and foot Secondary osteoarthritis, unspecified ankle and foot Pain in right ankle Pain in left ankle Pain in unspecified ankle Fracture of tibia or fibula following insertion of orthopedic implant, joint prosthesis, or bone plate, right leg Fracture of tibia or fibula following insertion of orthopedic implant, joint prosthesis, or bone plate, left leg Fracture of tibia or fibula following insertion of orthopedic implant, joint prosthesis, or bone plate, unspecified leg Wear of articular bearing surface of other internal prosthetic joint, initial encounter Breakdown (mechanical) of internal fixation device of bone of right lower leg, initial encounter Breakdown (mechanical) of internal fixation device of bone of left lower leg, initial encounter Displacement of internal fixation device of bone of right lower leg, initial encounter Displacement of internal fixation device of bone of left lower leg, initial encounter Displacement of internal fixation device of unspecified bone of limb, initial encounter Other mechanical complication of internal fixation device of bone of right lower leg, initial encounter Other mechanical complication of internal fixation device of bone of left lower leg, initial encounter Breakdown (mechanical) of other bone devices, implants and grafts, initial encounter Displacement of other bone devices, implants and grafts, initial encounter Other mechanical complication of other bone devices, implants and grafts, initial encounter Breakdown (mechanical) of other internal orthopedic devices, implants and grafts, initial encounter Displacement of other internal orthopedic devices, implants and grafts, initial encounter Other mechanical complication of other internal orthopedic devices, implants and grafts, initial encounter Presence of right artificial ankle joint Presence of left artificial ankle joint 10

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Z96.669 REFERENCES

Presence of unspecified artificial ankle joint

The foregoing Oxford policy has been adapted from an existing UnitedHealthcare national policy that was researched, developed and approved by UnitedHealthcare Medical Technology Assessment Committee. [2012T0554A] 1. American Academy of Orthopaedic Surgeons (AAOS). Technology Overview. The surgical treatment of ankle arthritis. December 2010. Available at: http://www.aaos.org/research/overviews/AnkleArthritis_surgical.pdf. Accessed October 18, 2011. 2. American College of Foot and Ankle Surgeons (ACFAS). Position Statement. Total ankle replacement surgery. March 2010. Available at: http://www.acfas.org/Physicians/Content.aspx?id=1933. Accessed October 18, 2011. 3. American Orthopaedic Foot and Ankle Society (AOFAS). Position Statement. Total ankle replacement surgery. August 2009. Available at: http://www.aofas.org/medicalcommunity/health-policy/Documents/TAR_0809.pdf. Accessed October 18, 2011. 4. 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. 2011 Jan;469(1):225-36. 5. Claridge RJ, Sagherian BH. Intermediate term outcome of the agility total ankle arthroplasty. Foot Ankle Int. 2009 Sep;30(9):824-35. 6. ECRI Institute. Hotline Service. Total ankle replacement system for degenerative ankle disease. December 2010. 7. ECRI Institute. Emerging Technology Report. Total ankle replacement for degenerative ankle disease. November 2009. 8. Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res. 2010 Jan;468(1):199-208. 9. 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 Sep;89(9):1899-905. 10. Hayes, Inc. Directory. Total ankle replacement. February 2010. Updated February 2011. 11. Henricson A, Skoog A, Carlsson A. The Swedish Ankle Arthroplasty Register: An analysis of 531 arthroplasties between 1993 and 2005. Acta Orthop. 2007 Oct;78(5):569-74. 12. Karantana A, Hobson S, Dhar S. The Scandinavian total ankle replacement: survivorship at 5 and 8 years comparable to other series. Clin Orthop Relat Res. 2010 Apr;468(4):951-7. 13. Kopp FJ, Patel MM, Deland JT, O'Malley MJ. Total ankle arthroplasty with the Agility prosthesis: clinical and radiographic evaluation. Foot Ankle Int. 2006 Feb;27(2):97-103. 14. Mann JA, Mann RA, Horton E. STAR ankle: long-term results. Foot Ankle Int. 2011 May;32(5):S473-84. 15. National Institute for Health and Clinical Excellence (NICE). Total ankle replacement surgery. March 2010. Available at: http://guidance.nice.org.uk/IP/359. Accessed October 18, 2011. 16. 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 Jul;30(7):579-96. 17. Schutte BG, Louwerens JW. Short-term results of our first 49 Scandinavian total ankle replacements (STAR). Foot Ankle Int. 2008 Feb;29(2):124-7. 18. Skytt ET, Koivu H, Eskelinen A, et al. Total ankle replacement: a population-based study of 515 cases from the Finnish Arthroplasty Register. Acta Orthop. 2010 Feb;81(1):114-8. 19. Stengel D, Bauwens K, Ekkernkamp A, Cramer J. Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis. Arch Orthop Trauma Surg. 2005 Mar;125(2):109-19. 20. Wood PL, Sutton C, Mishra V, Suneja R. A randomised, controlled trial of two mobile-bearing total ankle replacements. 9. J Bone Joint Surg Br. 2009 Jan;91(1):69-74.

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POLICY HISTORY/REVISION INFORMATION Date 09/14/2012 04/01/2012 Action/Description Added list of applicable ICD-10 codes (preview draft) in preparation for the transition from ICD-9 to ICD-10 medical coding on 10/01/14 New policy

Total Ankle Replacement Surgery (Arthroplasty): Clinical Policy (Effective 04/01/2012)

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1996-2012, Oxford Health Plans, LLC