Total Ankle Replacement

POLICY NUMBER

L.7.01.428

DESCRIPTION

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. The alternative to total ankle replacement is arthrodesis, which may lead to alterations in gait and onset of arthrosis in joints adjacent to the fusion. While both procedures are designed to reduce pain, total ankle replacement is also intended to improve function and reduce stress on adjacent joints. Total ankle replacement has been investigated since the 1970s, but in the 1980s the procedure was essentially abandoned due to a high long-term failure rate, both in terms of pain control and function. Newer models have since been developed, which can be broadly subdivided into two design types, fixed bearing and mobile bearing.

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 first fixed-bearing devices were implanted with cement fixation (cement fixation requires more removal of bone). In 2002, the U.S. Food and Drug Administration (FDA) approved the Agility Ankle Revision Prosthesis (DePuy Orthopaedics), which is intended for cemented use only in patients with a failed previous ankle surgery. In 2005, the FDA reviewed a 510(k) marketing clearance application for the Topez Total Ankle Replacement (Topez Orthopedics, Inc., Boulder, Colorado) and determined that it was substantially equivalent to the existing DePuy Agility device. The Topez Ankle is now called the Inbone™ Total Ankle (INBONE Technologies) and is also intended for cemented use only. The Agility™ LP (DePuy Orthopaedics) and the Eclipse (Kinetikos Medical) received 510(k) marketing clearance in 2006. The Salto Talaris™ (Tornier) received 510(k) marketing clearance in 2006 and 2009. These semi-constrained cemented prostheses are indicated in patients with end-stage ankle disorders (e.g., affected with severe rheumatoid, post-traumatic, or degenerative arthritis) as an alternative to ankle fusion.

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 and have a porous coating on the components to encourage osseo-integration. They include the Scandinavian Total Ankle Replacement (STAR®, Small Bone Innovations) the TNK ankle (Kyocera Corporation) and the Buechel-Pappas™ system. Three-component mobile-bearing systems are Class III devices, and are considered under a different regulatory pathway (pre-market approval) than the fixed component devices described above, which were cleared for marketing under the 510(k) regulatory pathway. Pre-market approval (PMA) requires demonstration of clinical efficacy in FDA-regulated trials conducted under an investigational device exemption (IDE). In May 2009, the FDA approved the STAR® ankle as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis or post-traumatic arthritis. As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next eight years. The TNK and Buechel-Pappas™ systems are not currently used in the U.S.

Total ankle replacement has been performed in patients with severe rheumatoid arthritis, severe osteoarthritis, or post-traumatic osteoarthrosis.

POLICY

Total ankle replacement using an FDA-approved device may be considered medically necessary in skeletally mature patients with moderate to severe ankle (tibiotalar) pain that limits daily activity and who have the following conditions:

• Arthritis in adjacent joints (i.e., subtalar or midfoot), or

• Severe arthritis of the contralateral ankle, or

• Arthrodesis of the contralateral ankle, or

• Inflammatory (e.g., rheumatoid) arthritis

The following Guideline may be used for Patient Selection Criteria:

Contraindications to Ankle Arthroplasty include:

Total ankle replacement is considered investigational for all other indications.

POLICY EXCEPTIONS

Federal Employee Program (FEP): FEP may dictate that all devices approved by the FDA, i.e., the Agility Ankle and the Agility Ankle Revision prosthesis, may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/2001: Approved by Medical Policy Advisory Committee (MPAC), CPT code 27702 added, ICD-9 procedure code 81.49 added, ICD-9 diagnosis code 711.07, 711.17, 711.27, 711.37, 711.47, 711.57, 711.67, 711.77, 711.87, 711.97, 714.0-714.89, 715.07-715.97 added

2/7/2002: Investigational definition added

5/8/2002: Type of Service and Place of Service deleted

5/29/2002: Code Reference section updated, ICD-9 procedure code 81.56 added, ICD-9 diagnosis codes 4th and 5th digit added 

3/14/2005: Policy reviewed, Description section revised to be consistent with BCBSA policy # 7.01.77 and Agility FDA marketing approval documents, Sources updated

8/25/2005: Code Reference section updated, CPT code 01486 added, ICD-9 procedure code 81.49 deleted, ICD-9 procedure code 81.59 added, ICD-9 diagnosis code 711.07, 711.17, 711.27, 711.37, 711.47, 711.57, 711.67, 711.77, 711.87, 711.97, 714.0-714.89, 715.07-715.97 deleted

3/15/2006: Coding updated. CPT4 2006 revisions added to policy

11/13/2006: Policy reviewed, no changes

9/18/2007: Policy reviewed, no changes

12/09/2009: Policy Description Section revised with new FDA approved devices information and ankle replacement indications. Policy Statement Section revised as follows: Total ankle replacement is now medically necessary for specific indications and only when used with a FDA-approved device. Guideline for Patient Selection Criteria added. Contraindications added. Total ankle replacement is investigational for all other indications added. Policy Exceptions Section revised to add FEP verbiage. Coding Section revised as follows: A Covered Codes Table added. CPT4 codes 27702 and 01486 moved from Non-Covered Codes Table to Covered. CPT4 code 27703 added to Covered Codes Table. ICD9 procedure codes 81.56 and 81.59 moved from Non-Covered Codes Table to Covered Codes Table. ICD9 diagnosis codes 714.0, 715.17, 715.27, 715.37, and 715.97 added to Covered Codes Table. Non-Covered Codes Table removed. Verbiage, "This is not intended to be comprehensive list of covered codes. Some codes may be variable, and coverage will be based on the clinical indication for the service.", "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." and "*This is not an all inclusive list of non-covered procedure codes." added.

10/21/2010: Policy reviewed; no changes.

10/05/2011: Policy reviewed. Deleted outdated references from the Sources section.

11/30/2012: Policy reviewed; no changes.

10/15/2013: Policy reviewed; no changes.

08/27/2015: Code Reference section updated to add ICD-10 codes.

06/08/2016: Policy number L.7.01.428 added. Investigative definition updated in Policy Guidelines section.

06/30/2023: Policy reviewed. Policy Guidelines updated to add Medically Necessary definition.

06/25/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.77

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.