Currentblue cross blue shield - kansasPolicy N/A

Total Ankle Replacement (TAR) Coverage Policy

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This medical policy governs coverage and medical necessity criteria for total ankle replacement (arthroplasty) using FDA‑approved devices for BCBS Kansas members; it outlines indications, contraindications, and the insurer's coverage stance. It applies to providers performing TAR and to members whose benefits are administered by BCBSKS.

Policy Summary

Payerblue cross blue shield - kansas

PolicyTotal Ankle Replacement

Policy CodePolicy N/A

Change TypeArchived — no scheduled review

Effective DateJun 29, 2010

Last ReviewApr 8, 2022

Next Review DateN/A

Key ActionSubmit a predetermination request or contact BCBSKS customer service to verify coverage and member benefits prior to total ankle replacement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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Currentblue cross blue shield - kansasPolicy N/A

Total Ankle Replacement (TAR) Coverage Policy

Customize your policy alerts

Sign up for all blue cross blue shield - kansas policy alerts

Know when blue cross blue shield - kansas releases new policies or updates existing guidance.

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Policy Summary

Payerblue cross blue shield - kansas

PolicyTotal Ankle Replacement

Policy CodePolicy N/A

Change TypeArchived — no scheduled review

Effective DateJun 29, 2010

Last ReviewApr 8, 2022

Next Review DateN/A

Key ActionSubmit a predetermination request or contact BCBSKS customer service to verify coverage and member benefits prior to total ankle replacement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9.8%weighted failure rate

23% vs 11%5-year major revision rates

Older, low-demandoptimal candidate profile

1,105systematic review TARs (2003-2008)

No reviewno further review scheduled

Coverage and Medical Necessity Criteria

inv-01: Medically necessary indications

Covered when ALL of the following are met:

Primary coverage criteria

Qualifying conditions: 1. Arthritis in adjacent joints (i.e., subtalar or midfoot); OR 2. Severe arthritis of the contralateral ankle; OR 3. Arthrodesis of the contralateral ankle; OR 4. Inflammatory (e.g., rheumatoid) arthritis.
Quoted from policy statement (chunk 7).

inv-02: Absolute contraindications

Absolute contraindications (TAR not appropriate if ANY of the following are present):

Absolute contraindications: 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.malalignment >15 degrees

Presence of any absolute contraindication precludes TAR per policy (chunk 7).

inv-03: Relative contraindications

Relative contraindications (factors that may contraindicate TAR or require caution):

Relative contraindications: Peripheral neuropathy; Ligamentous instability; Subluxation of the talus; History of ankle joint infection; Presence of severe deformities above or beneath the ankle.

Relative contraindications may influence candidacy but are not absolute exclusions (chunk 7).

inv-04: Medical necessity stance

Covered when ALL of the following are met (policy summary and clinical input):

General: Total ankle replacement may be considered medically necessary for selected patients with end-stage ankle arthritis when fusion is not indicated (for example, bilateral disease or coexisting subtalar or midfoot arthritis) and when patient selection is appropriate; this position is supported by clinical input from specialty societies and academic medical centers.

Derived from policy summary and clinical input (chunks 30,29).

Conservative treatment: Patients should have completed conservative treatment as used in pivotal trials, including a minimum of 6 months of conservative management with at least a 3-month trial of orthosis and/or analgesic medication.>=3 months orthosis/analgesics; >=6 months conservative care

Pivotal STAR trial inclusion criteria specified these conservative-treatment durations (chunk 23).

Patient selection considerations: Appropriate candidates typically include adults with primary, post-traumatic, or rheumatoid arthritis with moderate-to-severe pain, loss of mobility and function, satisfactory vascular perfusion, and adequate soft-tissue coverage; exclusionary factors from trials include hindfoot or forefoot malalignment, avascular necrosis, severe osteopenia/inadequate bone stock, insufficient ligament support, neuropathy, or neuromuscular impairment.

Total ankle replacement (TAR) is considered experimental/investigational for any indication other than those explicitly listed as medically necessary in this policy. The policy specifies the circumstances under which TAR using an FDA‑approved device may be considered medically necessary; uses outside those stated indications do not meet the policy's coverage criteria.

Pivotal trials and the policy exclude patients with certain conditions. Exclusionary criteria include hindfoot or forefoot malalignment, avascular necrosis (extensive talar dome AVN), severe osteopenia or inadequate bone stock, insufficient ligament support, neuropathy or neuromuscular impairment, and other compromised bone or soft‑tissue conditions. These factors were used as trial exclusion criteria and are cited as contraindications in the policy.

This policy record includes an archival note dated 02-17-2023. The policy states that no further routine review or update is scheduled because additional published literature is unlikely to change the policy position; providers should contact BCBSKS customer service or submit predetermination requests for coverage questions.

Total ankle replacement performed for indications not listed under the policy's medically necessary criteria is classified as experimental/investigational and therefore is not covered by this policy.

The procedure and diagnosis codes listed in the coding section (e.g., CPT 27702, 27703) are deemed medically necessary only if the procedure is performed in accordance with the 'Policy' section. If the clinical circumstances do not meet the policy criteria, the service may be considered not medically necessary and may not be covered.

Procedure and Diagnosis Codes

Procedure CPT CodesCPTCovered

27702	Arthroplasty, ankle; with implant (total ankle)
27703	Arthroplasty, ankle; revision, total ankle

Listed ICD-10 Diagnosis CodesICD-10

M00.071	Staphylococcal arthritis, right ankle and foot
M00.072	Staphylococcal arthritis, left ankle and foot
M00.171	Pneumococcal arthritis, right ankle and foot
M00.172	Pneumococcal arthritis, left ankle and foot
M00.271	Other streptococcal arthritis, right ankle and foot
M00.272	Other streptococcal arthritis, left ankle and foot
M00.871	Arthritis due to other bacteria, right ankle and foot
M00.872	Arthritis due to other bacteria, left ankle and foot
M02.171	Postdysenteric arthropathy, right ankle and foot
M02.172	Postdysenteric arthropathy, left ankle and foot

1–10 of 23

1/3

ICD-10 diagnoses (part 1)ICD-10

M02.171	Postdysenteric arthropathy, right ankle and foot
M02.172	Postdysenteric arthropathy, left ankle and foot
M02.371	Reiter's disease, right ankle and foot
M02.372	Reiter's disease, left ankle and foot
M02.871	Other reactive arthropathies, right ankle and foot
M02.872	Other reactive arthropathies, left ankle and foot
M05.471	Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot
M05.472	Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot
M05.49	Rheumatoid myopathy with rheumatoid arthritis of multiple sites

ICD-10 diagnoses (part 2)ICD-10

M05.571	Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot
M05.572	Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot
M05.59	Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites
M05.771	Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement
M05.772	Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement
M05.79	Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement
M05.871	Other rheumatoid arthritis with rheumatoid factor of right ankle and foot
M05.872	Other rheumatoid arthritis with rheumatoid factor of left ankle and foot
M05.89	Other rheumatoid arthritis with rheumatoid factor of multiple sites
M05.9	Rheumatoid arthritis with rheumatoid factor, unspecified

1–10 of 13

1/2

ICD-10 diagnoses (part 3)ICD-10

M06.271	Rheumatoid bursitis, right ankle and foot
M06.272	Rheumatoid bursitis, left ankle and foot
M06.29	Rheumatoid bursitis, multiple sites
M06.371	Rheumatoid nodule, right ankle and foot
M06.372	Rheumatoid nodule, left ankle and foot
M06.39	Rheumatoid nodule, multiple sites
M06.871	Other specified rheumatoid arthritis, right ankle and foot
M06.872	Other specified rheumatoid arthritis, left ankle and foot
M06.89	Other specified rheumatoid arthritis, multiple sites
M19.071	Primary osteoarthritis, right ankle and foot

1–10 of 11

1/2

ICD-10 diagnoses (part 4)ICD-10

M19.171	Post-traumatic osteoarthritis, right ankle and foot
M19.172	Post-traumatic osteoarthritis, left ankle and foot
M19.271	Secondary osteoarthritis, right ankle and foot
M19.272	Secondary osteoarthritis, left ankle and foot
M19.90	Unspecified osteoarthritis, unspecified site
M35.2	Behcet's disease

Provider Requirements, Prior Authorization, and Documentation

Documentation Required

Benefit verification and clinical documentation

Verify member benefits and eligibility prior to scheduling. Ensure clinical documentation supports indications, prior conservative treatments, and rationale for total ankle replacement.

Documented indications consistent with policy criteria
Records of prior treatments and timelines

Prior Authorization

Predetermination / prior authorization recommended

Predetermination or prior authorization is recommended. Submit a predetermination request or contact Blue Cross and Blue Shield of Kansas prior to performing total ankle replacement when coverage is uncertain.

Predetermination advised for cases not clearly meeting policy criteria
Codes are considered medically necessary only when procedure aligns with Policy

Clinical Background and Evidence Summary

Total ankle replacement (TAR) is presented as an alternative to ankle arthrodesis for patients with moderate‑to‑severe tibiotalar pain from arthritis who meet selection criteria. Device designs include fixed‑bearing systems (polyethylene locked into a baseplate, often cemented, providing stability but greater constraint) and mobile‑bearing (three‑piece) systems with an unattached polyethylene bearing intended to reduce constraint. TAR aims to relieve pain while preserving ankle motion, with the intent of potentially reducing adjacent‑joint degeneration compared with fusion; historically, failure rates were high but newer devices have been developed and studied.

Device Types, Endpoints, and Adverse Events

Fixed-bearing vs Mobile-bearing TAR — device design differences and clinical implications

Fixed-bearing (design)Polyethylene locked into baseplate (often cemented) — greater stability but increased constraint and edge-loading stress; early devices used cement fixation.

Mobile-bearing (design)Three-piece systems with an unattached polyethylene that articulates independently with tibial and talar components — intended to reduce constraint but may be less stable and risk dislocation and increased polyethylene wear.

Clinical implication — stability vs motion trade-offFixed-bearing: increased stability and constraint (potentially higher early loosening risk at bone–implant interface); Mobile-bearing: aims to preserve motion with lower edge-loading but higher risk of instability/dislocation and wear.

Fixation and osseointegrationFixed-bearing frequently implanted with cement; mobile-bearing are intended for uncemented implantation with porous coatings to encourage osseointegration.

Regulatory pathways — PMA/Class III vs other device regulatory context

Policy Summary

Payerblue cross blue shield - kansas

PolicyTotal Ankle Replacement

Policy CodePolicy N/A

Change TypeArchived — no scheduled review

Effective DateJun 29, 2010

Last ReviewApr 8, 2022

Next Review DateN/A

Key ActionSubmit a predetermination request or contact BCBSKS customer service to verify coverage and member benefits prior to total ankle replacement.

SourceLink

On This Page

Based on STAR trial inclusion/exclusion and summary statements (chunks 23,30).

Denial Risk

Denial risk for non‑specified indications

If clinical indications fall outside the specific criteria in this policy, the authorization request or TAR is at high risk for denial.

TARs for non‑specified indications may be denied

Billing Rule

Coverage contingent on member contract

Coverage of listed procedures and codes depends on the member's contract. Inclusion of codes in this policy does not guarantee coverage or reimbursement.

Inclusion of codes does not imply member coverage or provider reimbursement
Verify contract-specific exclusions or limitations

Documentation Required

Conservative treatment prerequisite

A minimum of 6 months of conservative treatment is generally required, including at least a 3-month trial of orthosis and/or analgesic medication as used in pivotal trials supporting total ankle replacement.

Documented 6-month conservative treatment trial
Documented 3-month trial of orthosis and/or analgesic medication

Step Therapy

Step therapy

No specific step-therapy sequence is defined in this policy; however providers should ensure conservative treatments have been attempted and documented before requesting authorization.

No explicit step therapy sequence specified
Ensure prior conservative measures are documented

Note

Contact for coverage questions / Predetermination guidance

For coverage questions or to submit documentation for predetermination, contact Blue Cross and Blue Shield of Kansas customer service, your professional or institutional relations representative, or submit a predetermination request.

Use predetermination when uncertain about coverage
Contact customer service or provider relations for assistance

Class III / PMA pathwayThree-component mobile-bearing systems are Class III devices that have undergone FDA Premarket Approval (PMA) and investigational device exemption (IDE) trials (e.g., STAR received FDA approval in 2009 with post‑approval evaluation requirements).

510(k) clearance pathwaySeveral fixed-bearing devices were cleared for marketing under the 510(k) regulatory pathway (e.g., Agility, Topez/Inbone, Agility LP, Eclipse, Salto Talaris).

Regulatory implications for evidencePMA devices require demonstration of clinical efficacy in FDA‑regulated trials and longer-term post-approval evaluation; 510(k) devices were cleared as substantially equivalent to predicate devices.

Failure (implant) — definition used in pooled studies (revision, arthrodesis, or amputation)

Pooled-study endpoint definitionFailure was defined as revision, arthrodesis, or amputation in pooled studies and systematic reviews.

Reported weighted failure rateIn a systematic review of studies (2003–2008, 1,105 TARs), the failure rate using this endpoint was 9.8% with weighted follow-up ~5.2 years.

Components of failure endpointIncludes any subsequent implant revision, conversion to arthrodesis (fusion), or limb amputation related to the procedure or implant.

Major adverse events — wound problems, infection, bone problems, nerve injury, reoperation, amputation as reported

Wound problemsWound-related complications were commonly reported (e.g., wound problems noted in STAR pivotal trial and continued-access study).

InfectionInfections reported included cases leading to major complications and at least one below‑knee amputation due to infection in the continued-access study.

Bone problems and fracturesImplant-related bone fractures and bony changes were reported among adverse events (e.g., bone fracture ~18% in STAR pivotal trial reporting).

Nerve injuryPerioperative nerve injury was frequently reported (e.g., 98 of 435 patients [22.5%] in the continued-access STAR registry had perioperative nerve injury).

Reoperation (including revision)Events requiring reoperation or revision were tracked as major adverse events (e.g., 8.5% required revision/removal/other intervention in continued-access group at 24 months).

AmputationAmputation was reported as an extreme adverse outcome (one below‑knee amputation occurred in the continued-access study due to infection).

ICD-10 diagnoses listed — summary of diagnosis categories enumerated in the policy

Postdysenteric and reactive arthropathiesM02.171, M02.172 (Postdysenteric arthropathy); M02.371, M02.372; M02.871, M02.872 (Reiter's and other reactive arthropathies).

Rheumatoid arthritis spectrumM05.471, M05.472, M05.49, M05.571, M05.572, M05.59, M05.771, M05.772, M05.79, M05.871, M05.872, M05.89, M05.9, M06.071, M06.072, M06.09, M06.271, M06.272, M06.29, M06.371, M06.372, M06.39, M06.871, M06.872, M06.89 (various rheumatoid classifications).

Osteoarthritis and related diagnosesM19.071, M19.072 (Primary osteoarthritis); M19.171, M19.172 (Post‑traumatic osteoarthritis); M19.271, M19.272 (Secondary osteoarthritis); M19.90 (Unspecified osteoarthritis); M35.2 (Behcet's disease).