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Date Printed: October 23, 2017: 02:18 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-99221-15

Original Effective Date: 02/15/10

Reviewed: 04/23/15

Revised: 10/01/16

Subject: Total Ankle Replacement

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update    
           

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). Some fixed-bearing designs have received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).

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. 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.

POSITION STATEMENT:

Total ankle replacement using an FDA-approved device meets the definition of medical necessity in skeletally mature patients with ankle pain that limits activities of daily living, documented failure of at least 6 consecutive months of conservative treatment (such as physical therapy, anti-inflammatory medication, splints or orthotic devices), and ONE of the following conditions:

AND NO evidence of the following:

NOTE: Optimal candidates for total ankle replacement are considered to be older (age older than 50), thin, low-demand individuals with minimal deformity. Patients should have no functional barriers to participation in a rehabilitation program.

Total ankle replacement is considered experimental or investigational for all other indications as there is a lack of clinical scientific evidence published in peer-reviewed literature to permit conclusions on safety and net health outcomes.

Revision or replacement of a total ankle device meets the definition of medical necessity when the device has failed and all medical necessity criteria outlined above are met.

BILLING/CODING INFORMATION:

CPT Coding:

27702

Arthroplasty ankle, with implant, total ankle

27703

Arthroplasty, ankle, revision total ankle

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

M05.071 – M05.079

Felty’s Syndrome, ankle and foot

M05.171 – M05.179

Rheumatoid lung disease with rheumatoid arthritis of ankle and foot

M05.271 – M05.279

Rheumatoid vasculitis with rheumatoid arthritis of ankle and foot

M05.371 – M05.379

Rheumatoid heart disease with rheumatoid arthritis of ankle and foot

M05.471 – M05.479

Rheumatoid myopathy with rheumatoid arthritis of ankle and foot

M05.571 – M05.579

Rheumatoid polyneuropathy with rheumatoid arthritis of ankle and foot

M05.671 – M05.679

Rheumatoid arthritis of ankle and foot with involvement of other organs and systems

M05.771 – M05.779

Rheumatoid arthritis with rheumatoid factor of ankle and foot without organ or systems involvement

M05.871 – M05.879

Other rheumatoid arthritis with rheumatoid factor of ankle and foot

M06.071 – M06.079

Rheumatoid arthritis without rheumatoid factor, ankle and foot

M06.871 – M06.879

Other specified rheumatoid arthritis, ankle and foot

M07.671 – M07.679

Enteropathic arthropathies, ankle and foot

M12.071

Chronic postrheumatic arthropathy [Jaccoud], right ankle and foot

M12.072

Chronic postrheumatic arthropathy [Jaccoud], left ankle and foot

M12.571 – M12.579

Traumatic arthropathy, ankle and foot

M12.871 – M12.879

Other specific arthropathies, not elsewhere classified, ankle and foot

M13.171 – M13.179

Monoarthritis, not elsewhere classified, ankle and foot

M19.071 – M19.079

Primary osteoarthritis ankle and foot

M19.171 – M19.179

Post-traumatic osteoarthritis, ankle and foot

M19.271 – M19.279

Secondary osteoarthritis, ankle and foot

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, attending physician treatment plan, progress notes, and treatment notes including documentation of symptoms, failure of at least 6 consecutive months of conservative treatment, and radiology reports (if applicable).

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Radiology

18726-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Current, discharge, or administered medications

34483-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

REIMBURSEMENT INFORMATION:

Reimbursement for the revision or replacement of a total ankle device is made only if the procedure was initially allowed.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Arthrodesis: The surgical fixation of a joint to promote bone fusion.

Charcot neuroarthropathy: Charcot's joint (neuropathic osteoarthropathy) is a progressive condition affecting the musculoskeletal system and is characterized by joint dislocation, pathologic fractures, and often debilitating deformities.

RELATED GUIDELINES:

Subtalar Arthroereisis, 02-99221-17

OTHER:

Other names used to report total ankle replacement:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Agility LP Ankle Replacement
Buechel-Pappas System|
Eclipse
Inbone Total Ankle
Salto Talaris
Scandinavian Total Ankle Replacement (STAR)
Topez Total Ankle Replacement

REFERENCES:

  1. American Academy of Orthopaedic Surgeons (AAOS). Technology Overview. The surgical treatment of ankle arthritis. 2010. Accessed at aaos.org 03/27/15.
  2. American College of Foot and Ankle Surgeons (ACFAS), Position Statement: Total Ankle Replacement Surgery, July 2013. Accessed at acfas.org, 03/27/15.
  3. American Orthopaedic Foot & Ankle Society, Position Statement: The Use of Total Ankle Replacement for the Treatment of Arthritic Conditions of the Ankle.Accessed at aofas.org, 03/27/15.
  4. Barg A, Knupp M, et al, Total ankle Replacement in Patients with Gouty Arthritis, J Bone Joint Surg Am. 2011; 93:357-66.
  5. Besse JL, et al, Total Ankle Arthroplasty in France, Orthopaedics & Traumatology: Surgery & Research (2010 96, 291-303.)
  6. Blue Cross Blue Shield Association, Total Ankle Replacement, 7.01.77, 08/13 (archived 2014).
  7. Bonnin M, et al, The Salto Total Ankle Arthroplasy, Clin Orthop Relat Res, 07/01/10.
  8. ClinicalTrials.gov, A Study of the Scandinavian Total Ankle Replacement (STAR) Versus Fusion for the Treatment of Degenerative Ankle Disease (Pivotal), sponsored by Link America, Inc. Accessed 11/03/10.
  9. ClinicalTrials.gov, Ankle Joint Replacement Outcomes Study, sponsored by Tornier. Accessed 11/03/10.
  10. ClinicalTrials.gov, Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study, sponsored by Capital District Health Authority, Canada. Accessed 11/05/09.
  11. ClinicalTrials.gov, Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion, sponsored by St. Michael’s Hospital, Toronto. Accessed 11/03/10.
  12. Doets HC, Zurcher AW, Salvage Arthrodesis for Failed Total Ankle Arthroplasty – clinical Outcome and Influence of Method of Fixation on Union Rate in 18 Ankles Followed for 3-12 Years, Acta Orthopaedica 2010; 81(1): 142-147.
  13. Giannini S, et al, Total Ankle Replacement Compatible with Ligament Function Produces Mobility, Good Clinical Scores, and Low Complication Rates, Clin Orthop Relat Res (2010) 468:2746-2753.
  14. Gougoulias N, et al, How Successful are Current Ankle Replacements? Clin Orthop Relat Res (2010) 468: 199-208.
  15. Guyer AJ, Richardson G, Current Concepts Review: Total Ankle Arthroplasty, Foot Ankle Int 2008: 29(2): 256-64.
  16. Karantana A, et al, The Scandinavian Total Ankle Replacement, Clin Orthop Relat Res (2010) 468: 951-957.
  17. Koivu H, Kohonen I, Sipola E, et al, Severe Periprosthetic Osteolytic Lesions After the Ankle Evolutive System Total Ankle Replacement, J Bone Joint Surg Br. 2009 Jul; 91(7): 907-14.
  18. Krause FG, et al, Impact of Complications in Total Ankle Replacement and Ankle Arthrodesis Analyzed with a Validated Outcome Measurement, J Bone Joint Surg Am. 2011; 93:830-9.
  19. Mann JA, et al, STAR™ Ankle: Long-Term Results, Foot & Ankle International, Vol. 32, No. 5, May 2011.
  20. Saltzman CL, Mann RA, Ahrens JE, et al, Prospective Controlled Trial of STAR Total Ankle Replacement Versus Ankle Fusion: Initial Results, Foot & Ankle International, American Orthopaedic Foot & Ankle Society, 2009.
  21. Skytta ET, et al, Total Ankle Replacement: A Population-Based Study of 515 Cases from the Finnish Arthroplasty Register, Acta Orthopaedica 2010; 81(1): 114-118.
  22. U.S. Food and Drug Administration, Scandinavian Total Ankle Replacement System (STAR Ankle) - P050050, accessed at accessdata.fda.gov 08/19/13.
  23. Wood PL, Sutton C, Mishra V, et al, A Randomised, Controlled Trial of Two Mobile-Bearing Total Ankle Replacements, 2009 Journal of bone and Joint Surgery, British Volume, Vol 91-B, Issue 1, 69-74.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/23/15.

GUIDELINE UPDATE INFORMATION:

02/15/10

New Medical Coverage Guideline.

12/15/10

Annual review; revised position statement to include medical necessity criteria; updated coding section, reimbursement section and references; related ICD-10 codes added; and formatting changes.

09/15/11

Annual review; position statements maintained, references updated, and formatting changes.

10/15/12

Annual review: position statements maintained and references updated.

10/15/13

Annual review; position statements maintained, program exception section and references updated.

10/15/14

Annual review; position statements maintained and references updated.

05/15/15

Annual review; position statements maintained and references updated.

10/01/15

Revision; ICD9 & ICD10 coding sections updated.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision; formatting changes.

Date Printed: October 23, 2017: 02:18 AM