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. 2024 Mar 24;9(1):24730114241239310. doi: 10.1177/24730114241239310

Evidence Guiding Commercial Payer Coverage Criteria for Total Ankle Arthroplasty

Jacob L Kotlier 1, Amir Fathi 1, Meng-Yung Ong 1, Josh M Yazditabar 1, Ethan E Panoussi 1, Cory K Mayfield 1, Frank A Petrigliano 1,, Joseph N Liu 1, Alexander B Peterson 1, Eric W Tan 1
PMCID: PMC10962051  PMID: 38529013

Abstract

Background:

Total ankle arthroplasty (TAA), first developed as an alternative to ankle arthrodesis, has become an increasingly popular management option for end-stage ankle arthritis. Prior studies have shown commercial insurance payers base their coverage criteria on limited and low level of evidence research. This study aims to quantify and describe the evidence insurance companies use to support TAA coverage policies.

Methods:

The top 11 national commercial health insurance payers for TAA were identified. A google search was performed to identify payer coverage policies. Policy documents were examined and cited references were classified by type of reference as well as reviewed for level of evidence (LOE). Specific coverage criteria for each individual payer were then extracted. Criteria were compared to assess for similarities among commercial payers. Finally, all references cited by each payer were examined to determine whether they mentioned the specific payer criteria.

Results:

Six of the 11 payers had accessible coverage policies. The majority of cited references were primary journal articles (145, 60.9%) and the majority of references cited (179, 75.2%) were level III or level IV evidence. We found significant homogeneity in coverage criteria among payers. In addition, cited sources inconsistently mentioned specific payer coverage criteria.

Conclusion:

This study demonstrates that commercial insurance payers rely on the relatively low level of currently available scientific evidence when formulating coverage policies for TAA use and adopt criteria that have not been thoroughly analyzed in the literature. More high level of evidence research is needed to help clinicians and insurance companies further refine indications for TAA so that patients who might benefit from the procedure are adequately covered.

Level of Evidence:

Level IV, review.

Keywords: total ankle replacement, total ankle arthroplasty, commercial payer, coverage policy, coverage criteria, indications, references

Introduction

Total ankle arthroplasty (TAA) was first developed in the 1970s as an alternative to ankle arthrodesis for end-stage ankle arthritis. 11 Although early attempts at TAA had high complication rates, better implant design has led to improvements in outcomes.2,9,13 As such, utilization of TAA has continued to rise. Analysis of the Medicare database from 2005 to 2012 has shown a 16.37% annual growth rate in TAA utilization. 8 As utilization of TAA increases, payment and coverage become increasingly important topics for surgeons, hospitals, and commercial payers.

A variety of strategies have been employed by commercial payers to control the costs of medical services. In 2006, the Tax Relief and Health Care Act allowed Centers for Medicare and Medicaid Services (CMS) to retrospectively review claims of medical necessity for services based on region-specific Local Coverage Determinations (LCDs). 1 If claims were retrospectively found to not fulfill LCD criteria, compensation could be demanded in the form of physician payments and/or deductions from future reimbursements. 3 However, an analysis of LCD criteria for hip and knee arthroplasty in Florida found minimal and low level of evidence (LOE) references used to support criteria recommending conservative management and duration of conservative management. 3

Current commercial payers are forced to prospectively utilize coverage policies to determine medical necessity of procedures. However, this can limit and/or delay treatment for patients with severe pain or loss of functionality. This is especially true as coverage criteria for arthroplasty almost always specify that patients must have failed a period of conservative treatment. Previous studies in the total joint arthroplasty (TJA) and total shoulder arthroplasty (TSA) literature have found that such requirements for attempted nonoperative management are poorly supported both by the references in the coverage policy document and by available literature on the subject.1,17 More generally, these same studies have shown that the references used to support all commercial insurance coverage criteria for TJA and TSA tend to be of low level of evidence.1,17

The purpose of this study was to analyze commercial payer coverage policies for TAA in the United States and to characterize the references used to support these policies. To our knowledge, this is the first such study. We hypothesized that payer coverage documents would be supported by primarily low LOE references and would offer limited support for specific payer coverage criteria.

Materials and Methods

The top 11 national commercial health insurance payers for TAA were identified. A Google search was performed for each payer to find publicly available coverage policies pertaining to TAA. Search terms included “total ankle replacement” and “total ankle arthroplasty” followed by the individual payer name and the term “coverage policy.” For policies unable to be found through Google search, a phone call and email was sent to the company asking for coverage policy for TAA. A standardized review process was implemented for each policy. Policy documents were examined for references supporting coverage policies. Supporting references were then screened by title and/or abstract for relevance to TAA (as policy documents may cover multiple procedures). Exclusion criteria for references were irrelevance to TAA, full-text unavailable, and not in English language. Selected references were then categorized into type of reference, reviewed for level of evidence (LOE) per accepted published criteria, 19 and assessed for mention of specific coverage criteria. References were categorized into the following types of references: primary journal article, review article, expert opinion article, society guideline, governmental report or guideline, website, textbook, miscellaneous, or not found. Policy documents were analyzed for coverage criteria related to TAA, and a combined list of coverage criteria was created. The references were assessed for mention of criteria according to this combined list.

Results

Overall

The TAA coverage policies and associated references were obtained for 6 commercial payers (Aetna, Anthem, Cigna, Health Care Services Corporation, Highmark, United Healthcare). Coverage policies were not publicly accessible for the remaining 5 (Centene, Humana, Kaiser Permanente, The UPMC Health Plan, WellCare Health Plans). After screening of references and removal of duplicates, 278 unique references were analyzed, of which 40 full-texts were unavailable. One-hundred forty-five references (60.9%) were classified as primary journal articles, 65 (27.3%) were classified as review articles, 6 (2.5%) were classified as expert opinion, 7 (2.9%) were classified as society guidelines, 3 (1.3%) were classified as government reports/guidelines, 2 (0.8%) were classified as websites, and 10 (4.2%) were classified as miscellaneous (Table 1). LOE was level I in 4 references (1.7%), level II in 24 references (10.1%), level III in 71 references (29.8%), level IV in 108 references (45.4%), level V in 17 references (7.1%), and unable to be determined in 14 references (5.9%) (Table 2, Figure 1).

Table 1.

Reference Types by Payer and in Sum.

Commercial Payer Total References Primary Journal Articles Review Articles Expert Opinion Society Guidelines Government Report/Guideline Website Miscellaneous
Aetna 115 71 33 2 0 2 1 6
Anthem 50 35 13 1 0 1 0 0
Cigna 59 33 17 2 2 0 2 3
HCSC 33 17 13 1 2 0 0 0
Highmark 15 12 2 0 0 0 0 1
United Healthcare 6 1 1 0 3 0 0 1
Totals, n (%) 238 145 (60.9) 65 (27.3) 6 (2.5) 7 (2.9) 3 (1.3) 2 (0.8) 10 (4.2)

Abbreviation: HCSC, Health Care Services Corporation.

Table 2.

Reference Level of Evidence by Payer and in Sum.

Commercial Payer LOE I LOE II LOE III LOE IV LOE V Unable to be Determined
Aetna 1 9 36 55 8 6
Anthem 1 10 19 19 0 1
Cigna 2 6 22 20 6 3
HCSC 0 2 3 24 4 0
Highmark 1 1 2 10 0 1
United Healthcare 1 0 1 0 0 4
Totals, n (%) 4 (1.7) 24 (10.1) 71 (29.8) 108 (45.4) 17 (7.1) 14 (5.9)

Abbreviations: HCSC, Health Care Services Corporation; LOE, level of evidence.

Figure 1.

Figure 1.

Reference level of evidence by payer.

After analysis of all 6 commercial payer coverage criteria, the following combined list of coverage criteria was created: US Food and Drug Administration (FDA)-approved implant, skeletal maturity, failure of conservative management, severe pain, loss of function or mobility, advanced ankle arthritis, arthritis of adjacent joints, severe arthritis of contralateral ankle, arthrodesis of contralateral ankle, presence of inflammatory arthritis, and good lower extremity vascular perfusion. Table 3 displays the specific coverage criteria included by each commercial payer. References were examined for mention of these criteria. For failure of conservative management, references were examined for mention of duration of conservative management. Of the 238 references, 135 references (56.7%) mentioned an FDA-approved implant, 22 references (9.2%) mentioned skeletal maturity, 80 references (33.6%) mentioned severe pain, 74 references (31.1%) mentioned loss of function or mobility, 199 references (83.6%) mentioned advanced ankle arthritis, 22 references (9.2%) mentioned arthritis of adjacent joints, 18 references (7.6%) mentioned severe arthritis of contralateral ankle, 23 references (9.7%) mentioned arthrodesis of contralateral ankle, 139 references (58.4%) mentioned presence of inflammatory arthritis, 86 references (36.1%) mentioned good lower extremity vascular perfusion, and 91 references (38.2%) specified surgical candidacy. Only 6 references (2.5%) mentioned the duration of conservative treatment. Four references (1.7%) specified 6 months as length of conservative treatment, whereas 2 references (0.8%) specified 12 weeks as length of conservative treatment (Table 4, Figure 2).

Table 3.

Inclusion of Common Coverage Criteria by Commercial Payer.

Criteria FDA-Approved Implant Skeletal Maturity Failure of Conservative Management Severe Pain Loss of Function or Mobility Advanced Ankle Arthritis Arthritis of Adjacent Joints Severe Arthritis of Contralateral Ankle Arthrodesis (Fusion) of Contralateral Ankle Presence of Inflammatory Arthritis
Aetna 6 mo
Anthem 3 mo
Cigna 6 mo
HCSC 6 mo
Highmark 6 mo

Abbreviations: FDA, US Food and Drug Administration; HCSC, Health Care Services Corporation.

Table 4.

Number and Percentage of References Cited by Each Payer That Mention Their Specific Coverage Criteria.

FDA Approved Implant, n (%) Mentions Skeletal Maturity, n (%) Failure of Conservative Management, n (%) Severe Pain, n (%) Loss of Function or Mobility, n (%) Advanced Ankle Arthritis, n (%) Arthritis of Adjacent Joints, n (%) Severe Arthritis of Contralateral Ankle, n (%) Arthrodesis (Fusion) of Contralateral Ankle, n (%) Presence of Inflammatory Arthritis (eg, Rheumatoid), n (%) Adequate Lower-Extremity Vascular Perfusion, n (%)
Aetna 61 (53.0) 10 (8.7) 2 (1.7) 44 (38.3) 35 (30.4) 104 (90.4) 10 (8.7) 16 (13.9) 11 (9.6) 81 (70.4) 35 (30.4)
Anthem 31 (62.0) 5 (10.0) 1 (2.0) 7 (14.0) 11 (22.0) 37 (74.0) 5 (10.0) 0 (0.0) 8 (16.0) 18 (36.0) 19 (38.0)
Cigna 38 (64.4) 7 (11.9) 2 (3.4) 16 (27.1) 20 (33.9) 46 (78.0) 3 (5.1) 4 (6.8) 2 (3.4) 25 (42.4) 26 (44.1)
HCSC 23 (69.7) 0 (0.0) 2 (6.1) 13 (39.4) 10 (30.3) 25 (75.8) 3 (9.1) 3 (9.1) 5 (15.2) 26 (78.8) 12 (36.4)
Highmark 4 (26.7) 1 (6.7) 1 (6.7) 6 (40.0) 4 (26.7) 14 (93.3) 1 (6.7) 0 (0.0) 0 (0.0) 12 (80.0) 3 (20.0)
United 0 (0.0) 2 (33.3) 1 (16.7) 6 (100.0) 5 (83.3) 6 (100.0) 2 (33.3) 0 (0.0) 0 (0.0) 1 (16.7) 1 (16.7)
Total 135 (56.7) 22 (9.2) 6 (2.5) 80 (33.6) 74 (31.1) 199 (83.6) 22 (9.2) 18 (7.6) 23 (9.7) 139 (58.4) 86 (36.1)

Abbreviations: FDA, US Food and Drug Administration; HCSC, Health Care Services Corporation.

Figure 2.

Figure 2.

Number and percentage of references cited by each payer that mention their specific coverage criteria.

Aetna

Aetna had 115 references that were analyzed. Reference type and level of evidence can be found in Tables 1 and 2, respectively. Ten references (8.7%) mentioned arthritis of adjacent joints, 16 references (13.9%) mentioned severe arthritis of contralateral ankle, and 11 references (9.6%) mentioned arthrodesis of the contralateral ankle (Table 4, Figure 2). Two references (1.7%) mentioned the duration of conservative treatment, with both specifying 6 months (Table 4, Figure 2).

Anthem

Anthem had 50 references that were analyzed, none of which were cited within the text of the coverage policy. Five references (10.0%) mentioned arthritis of adjacent joints, 0 references (0%) mentioned severe arthritis of contralateral ankle, and 8 references (16.0%) mentioned arthrodesis of contralateral ankle (Table 4, Figure 2). One reference (2.0%) mentioned duration of conservative treatment of 6 months (Table 4, Figure 2).

Cigna

Cigna had 59 references that were analyzed, of which 10 were cited in the text of their coverage policy. Three references (5.1%) mentioned arthritis of adjacent joints, 4 references (6.8%) mentioned severe arthritis of the contralateral ankle, and 2 references (3.4%) mentioned arthrodesis of the contralateral ankle (Table 4, Figure 2). Two references (3.4%) mentioned the duration of conservative treatment, with both specifying 6 months (Table 4, Figure 2).

Health Care Services Corporation

Health Care Services Corporation had 33 references that were analyzed. Eight of these references were cited in the full text of their coverage policy. Three references (9.1%) mentioned arthritis of adjacent joints, 3 references (9.1%) mentioned severe arthritis of contralateral ankle (Table 4, Figure 2). Two references (6.1%) mentioned the duration of conservative treatment, with both specifying 12 weeks (Table 4, Figure 2).

Highmark

Highmark had 15 references that were analyzed. None were cited in the full text of the coverage policy. The most recent reference was published in 2010. One reference (6.7%) mentioned arthritis of adjacent joints, 0 references (0%) mentioned severe arthritis of the contralateral ankle, and 0 references (0%) mentioned arthrodesis of the contralateral ankle (Table 4, Figure 2). One reference (6.7%) mentioned duration of conservative treatment of 6 months (Table 4, Figure 2).

United Healthcare

United Healthcare had 6 references that were analyzed, all of which were cited in the full text of the coverage policy. United Healthcare did not provide coverage criteria within their coverage policy. Rather, in their coverage policy, they referenced an independent contractor who provides their coverage criteria; however, this document was not publicly accessible. Two references (33.3%) mentioned arthritis of adjacent joints, 0 references (0%) mentioned severe arthritis of the contralateral ankle, and 0 references (0%) mentioned arthrodesis of the contralateral ankle (Table 4, Figure 2). One reference (16.7%) mentioned duration of conservative treatment of 6 months (Table 4, Figure 2).

Discussion

The results of this study demonstrate that in their coverage policies for TAA, commercial insurance payers cite poor quality references, occasionally cite their references improperly in the policy document, and are forced to rely on low–level of evidence studies to formulate their specific coverage criteria. This study found that of the 238 unique articles screened, most (60.9%) were primary journal articles and only 11.8% were level I or level II evidence. Analysis of payer coverage criteria demonstrated a high degree of homogeny among payers. Finally, this study found that the references cited by commercial payers rarely investigate their specific coverage criteria.

Our results show that insurance companies cite primary journal articles most frequently in their coverage policies for TAA and that they most frequently cite studies of level IV evidence (45.4%). Our findings are consistent with prior studies in the total joint arthroplasty (TJA) and total shoulder arthroplasty (TSA) literature. In a 2021 study by Austin et al 1 examining commercial insurance payer coverage policies for TJA, the authors found that of the 282 documents reviewed, 45.8% were primary journal articles, 14.2% were level I or II evidence, and only 41.2% of sources were applicable to patients who were candidates for TJA. Sudah et al conducted a similar study in the TSA literature. They also found that primary journal articles (n = 70; 59.3%) were the most frequently cited and that most references were of level IV evidence (n = 60; 52.2%). 17 Only 6 (5.2%) of the sources they analyzed were level I or II evidence. 17 Of the 238 unique references analyzed in our study, only 4 (1.7%) were level I evidence and 24 (10.1%) were level II. Thus, it appears that commercial payers tend to support their coverage policies for TAA with low level evidence. Although there have been several recent high–level of evidence studies,5,6,12,14,16 level I and II studies on TAA do remain relatively scarce, which could explain this finding.

By examining coverage criteria among the 6 payers analyzed, this study demonstrated close similarities across the different commercial insurance payers. This could be ascribed to a common consensus on indications for the procedure; however, given the lack of high–level of evidence studies on TAA, there is some concern that insurance companies may not have the necessary information to justify both their specific indications and such broad consensus. These adopted criteria have the potential to perpetuate inaccurate indications for TAA; nevertheless, the solution to this problem lies in more high–level of evidence studies on the subject.

As in hip, knee, and shoulder arthroplasty, osteoarthritis is the most common condition requiring TAA. Analysis of insurance coverage criteria for these arthroplasty procedures reveals they are closely related and all require some period of conservative treatment before insurance companies with coverage arthroplasty.1,17 Previous research has shown that this period of conservative management is not well supported in the hip, knee, and shoulder arthroplasty literature.1,17 The same appears to be true for TAA.

All of the payers analyzed included a criterion specifying the need to have failed conservative management. Four payers (Aetna, Cigna, HCSC, Highmark) require patients to have failed 6 months of conservative management and 1 payer (Anthem) requires they fail 3 months. However, there is little support for the efficacy of conservative management in severe ankle arthritis. A 2013 paper by Labib et al 7 found, after an extensive review of the literature, that there were no articles specifically investigating the nonoperative management of ankle arthritis. A review of literature for this study also revealed a lack of studies on conservative management of ankle arthritis. The results of our study also support the notion that failure of conservative management is not a common consideration when investigating ankle arthritis, because among the 238 articles analyzed for this study, only 6 mentioned that patients included in the study had failed nonoperative management. Four of these articles had a time period of 6 months and two a time period of 3 months.

Another common coverage criterion required patients to have documented severe arthritis of the contralateral ankle or arthrodesis of the contralateral ankle; however, this criterion is rarely mentioned in the text of coverage policy references. In combination with the fact that around 70% of ankle arthritis cases are posttraumatic, this criterion makes it seem as if patients with unilateral posttraumatic ankle arthritis will not be covered for TAA 10 and instead forced to undergo arthrodesis of the affected joint. Although, in reality, many of these patients end up receiving TAA, this criterion remains somewhat misleading.

Research comparing outcomes between ankle arthrodesis and TAA have demonstrated similar patient-reported outcomes between the two with slightly high rates of reoperation in TAA patients.6,18 However, TAA does appear to offer certain advantages that may be beneficial for some patients. A 2020 study by Sanders et al 15 comparing gait and stair ascent between patients with TAA and arthrodesis found sagittal ankle range of motion during level walking, forefoot-tibia motion, and hindfoot-tibia motion were significantly greater in the TAA group (all P < .05). During stair ascent, sagittal ankle ROM, forefoot-tibia, and hindfoot-tibia motion were also all significantly greater (all P < .05) in the TAA group. 15 Analyzing gait in TAA patients and ankle arthrodesis patients, Flavin et al 4 found TAA patients had better sagittal dorsiflexion (P = .001) and vertical ground force reaction curve more similar to controls; however, arthrodesis had superior coronal plane eversion (P = .01). Given the apparent biomechanical differences produced by the 2 procedures, patients and physicians should be able to choose between the two and select the better procedure for each individual patient.

This study had several limitations. The first was that we were only able to access the coverage policy document for 6 of the 11 investigated payers. Nevertheless, the 6 included payers cover more than 100 million patients in the United States, which makes the results of this study relevant to a substantial proportion of the population. We also believe it is possible, given the homogeneity of criteria among payers, that findings for the payers analyzed may be representative of those payers we did not analyze. Another limitation is that we were unable to access the specific coverage criteria for United Healthcare. United Healthcare contracts its coverage criteria to an independent contractor and the criteria were thus locked behind a paywall and not accessible to the public. Given the relative lack of level I and II studies investigating TAA, we were also limited in our ability to draw conclusions based on study level of evidence referenced by commercial payers. Finally, we were unable to access the full texts for 40 of the sources found in the references of the commercial payer documents; however, the majority of these sources were either published prior to 1990 or not published in English.

This study demonstrates that commercial insurance payer coverage policies for TAA cite primarily low-level evidence and must rely on these studies when formulating their coverage criteria for the procedure. This study also shows that coverage criteria are highly similar among the included payers. Our analysis highlights the importance of continuing to pursue high–level of evidence research on TAA in order to allow physicians and insurance companies to make better-informed decisions as to the appropriate indications for the procedure. Given the improved success of third-generation ankle implants, it is key that we both identify appropriate candidates and work to ensure their insurance covers the procedure.

Supplemental Material

sj-pdf-1-fao-10.1177_24730114241239310 – Supplemental material for Evidence Guiding Commercial Payer Coverage Criteria for Total Ankle Arthroplasty

Supplemental material, sj-pdf-1-fao-10.1177_24730114241239310 for Evidence Guiding Commercial Payer Coverage Criteria for Total Ankle Arthroplasty by Jacob L. Kotlier, Amir Fathi, Meng-Yung Ong, Josh M. Yazditabar, Ethan E. Panoussi, Cory K. Mayfield, Frank A. Petrigliano, Joseph N. Liu, Alexander B. Peterson and Eric W. Tan in Foot & Ankle Orthopaedics

Appendix 1.

Commercial Payer Reference (Title) Year Type of Reference
Aetna Total ankle arthroplasty 2010 Expert opinion
Aetna Design comparison of the INBONE I versus INBONE II total ankle system 2013 Expert opinion
Aetna Total ankle replacements: clinical effectiveness and a review of the guidelines 2008 Government guideline
Aetna Eclipse total ankle implant: summary of safety and effectiveness 2006 Government report
Aetna Scandinavian Total Ankle Replacement System: summary of safety and effectiveness 2009 Miscellaneous
Aetna Topez total ankle replacement 2005 Miscellaneous
Aetna Salto Talaris total ankle prosthesis 2009 Miscellaneous
Aetna Inbone II Total Ankle System: summary of safety and effectiveness 2010 Miscellaneous
Aetna Infinity total ankle replacement 2014 Miscellaneous
Aetna Zimmer trabecular metal total ankle 2012 Miscellaneous
Aetna The INBONE II total ankle system 2013 Primary journal article
Aetna Comparison of total ankle arthroplasty and ankle arthrodesis in end-stage hemophilic arthropathy 2020 Primary journal article
Aetna Total ankle arthroplasty: new concepts and approaches 1991 Primary journal article
Aetna Total ankle replacement in obese patients: component stability, weight change, and functional outcome in 118 consecutive patients 2011 Primary journal article
Aetna The Agility total ankle arthroplasty: a concise follow-up at a minimum of 20 years 2021 Primary journal article
Aetna Functional outcome of meniscal-bearing total ankle replacement: a gait analysis study 2008 Primary journal article
Aetna Long-term follow-up of Bologna-Oxford (BOX) total ankle arthroplasty 2021 Primary journal article
Aetna The Salto total ankle arthroplasty: survivorship and analysis of failures at 7 to 11 years 2011 Primary journal article
Aetna Ankle function and sports activity after total ankle arthroplasty 2009 Primary journal article
Aetna The impact of obesity on the outcome of total ankle replacement 2015 Primary journal article
Aetna Ten-year evaluation of cementless Buechel-Pappas meniscal bearing total ankle replacement 2003 Primary journal article
Aetna New Jersey low contact stress total ankle replacement: Biomechanical rationale and review of 23 cementless cases 1988 Primary journal article
Aetna Radiostereometric analysis of the double-coated STAR total ankle prosthesis: a 3-5 year follow-up of 5 cases with rheumatoid arthritis and 5 cases with osteoarthrosis 2005 Primary journal article
Aetna The surgical treatment for degenerative disease of the ankle 2000 Primary journal article
Aetna Complications of total ankle replacement 2002 Primary journal article
Aetna Relationship between body mass index and complications in total ankle arthroplasty: A single surgeon’s experience in ninety-seven replacements 2018 Primary journal article
Aetna Quality of life in bilateral vs. unilateral end-stage ankle arthritis and outcomes of bilateral vs. unilateral total ankle replacement 2017 Primary journal article
Aetna Evaluation of the early result of Smith total ankle replacement 1980 Primary journal article
Aetna Total ankle replacement versus ankle arthrodesis for patients aged 50-85 years with end-stage ankle osteoarthritis: the TARVA RCT 2023 Primary journal article
Aetna The effect of obesity on functional outcomes and complications in total ankle arthroplasty 2015 Primary journal article
Aetna Ankle arthroplasty with preoperative coronal plane deformity: short-term results 2004 Primary journal article
Aetna Patient-specific instrumentation vs standard referencing in total ankle arthroplasty: a comparison of the radiologic outcome 2022 Primary journal article
Aetna Long-term results of total ankle replacement 1986 Primary journal article
Aetna The Swedish Ankle Arthroplasty Register: an analysis of 531 arthroplasties between 1993 and 2005 2006 Primary journal article
Aetna HINTEGRA revision arthroplasty for failed total ankle prostheses 2013 Primary journal article
Aetna A New Zealand national joint registry review of 202 total ankle replacements followed for up to 6 years 2007 Primary journal article
Aetna Clinical outcomes of total ankle arthroplasty with total talar prosthesis 2019 Primary journal article
Aetna The Scandinavian Total Ankle Replacement: survivorship at 5 and 8 years comparable to other series 2010 Primary journal article
Aetna Revision of STAR total ankle replacement to hybrid AES-STAR total ankle replacement - a report of two cases 2009 Primary journal article
Aetna Ankle arthroplasty in patients younger and older than 50 years: a prospective series with long-term follow-up 2000 Primary journal article
Aetna Severe periprosthetic osteolytic lesions after the Ankle Evolutive System total ankle replacement 2009 Primary journal article
Aetna Total ankle arthroplasty incorporating a total talar prosthesis: a comparative study against the standard total ankle arthroplasty 2019 Primary journal article
Aetna Revision rates after total ankle arthroplasty in sample-based clinical studies and national registries 2011 Primary journal article
Aetna Total ankle replacement in rheumatoid arthritis 1984 Primary journal article
Aetna Analysis of ankle range of motion and functional outcome following total ankle arthroplasty 2010 Primary journal article
Aetna Total ankle arthroplasty versus ankle arthrodesis—a comparison of outcomes over the last decade 2017 Primary journal article
Aetna Comparison of intermediate-term outcomes of total ankle arthroplasty in patients younger and older than 55 years 2019 Primary journal article
Aetna Transfibular total ankle arthroplasty: a new reliable procedure at five-year follow-up 2022 Primary journal article
Aetna Malleolar fracture after total ankle arthroplasty: a comparison of two designs 2004 Primary journal article
Aetna Total ankle replacement by the Ankle Evolution System: medium-term outcome 2010 Primary journal article
Aetna Clinical-radiological outcomes and complications after total ankle replacement through a lateral transfibular approach: a retrospective evaluation at a mid-term follow-up 2021 Primary journal article
Aetna Safety of outpatient total ankle arthroplasty vs traditional inpatient admission or overnight observation 2017 Primary journal article
Aetna Total ankle replacement: early experiences with STAR prosthesis. 2005 Primary journal article
Aetna Habitual physical activity and sports participation after total ankle arthroplasty 2008 Primary journal article
Aetna Total ankle arthroplasty versus ankle arthrodesis: a comparative analysis of arc of movement and functional outcomes 2016 Primary journal article
Aetna Ankle replacement versus arthrodesis: a comparative gait analysis study 2008 Primary journal article
Aetna Trends in the use of total ankle replacement and ankle arthrodesis in the United States Medicare population 2013 Primary journal article
Aetna Total ankle arthroplasty: a unique design. Two to twelve-year follow-up 1998 Primary journal article
Aetna Trends in treatment of advanced ankle arthropathy by total ankle replacement or ankle fusion 2014 Primary journal article
Aetna Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results 2009 Primary journal article
Aetna Effect of Obesity on Total Ankle Arthroplasty Outcomes 2016 Primary journal article
Aetna Total ankle arthroplasty using biological fixation components compared to ankle arthrodesis 1987 Primary journal article
Aetna Perioperative complications of the Agility total ankle replacement in 50 initial, consecutive cases 2006 Primary journal article
Aetna Total ankle arthroplasty versus ankle arthrodesis. Comparison of sports, recreational activities and functional outcome 2011 Primary journal article
Aetna Short-term results of our first 49 Scandinavian Total Ankle Replacements (STAR) 2008 Primary journal article
Aetna Early prospective clinical results of a modern fixed-bearing total ankle arthroplasty 2013 Primary journal article
Aetna Polyethylene fracture following STAR ankle arthroplasty: a report of three cases 2009 Primary journal article
Aetna Preference-based quality of life of end-stage ankle arthritis treated with arthroplasty or arthrodesis 2010 Primary journal article
Aetna Cost-effectiveness analysis of total ankle arthroplasty 2004 Primary journal article
Aetna Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty 2007 Primary journal article
Aetna Complications and failure after total ankle arthroplasty 2004 Primary journal article
Aetna Intermediate to long-term clinical outcomes and survival analysis of the Salto Mobile Bearing total ankle prothesis 2022 Primary journal article
Aetna Reoperation and patient satisfaction after the Mobility total ankle arthroplasty 2012 Primary journal article
Aetna Ankle arthroplasty: a comparative study of cemented metal and uncemented ceramic prostheses 1990 Primary journal article
Aetna Total ankle arthroplasty in rheumatoid arthritis: a long-term follow-up study 1988 Primary journal article
Aetna Clinical and radiological outcomes of transfibular total ankle arthroplasty 2019 Primary journal article
Aetna Sports and recreation activity of ankle arthritis patients before and after total ankle replacement 2006 Primary journal article
Aetna The feasibility of total ankle prosthesis for severe arthropathy in hemophilia and prothrombin deficiency 2006 Primary journal article
Aetna Total ankle replacement: medium-term results in 200 Scandinavian total ankle replacements 2008 Primary journal article
Aetna A randomized, controlled trial of two mobile-bearing total ankle replacements 2009 Primary journal article
Aetna Clinical comparison of two total ankle replacements 2000 Primary journal article
Aetna Long-term follow-up of the Conaxial (Beck-Steffee) total ankle arthroplasty 1992 Primary journal article
Aetna A systematic review of intermediate-term outcomes and failure rates for total ankle replacements: an Asian perspective 2013 Review
Aetna Surgical procedures in patients with hemophilic arthropathy of the ankle 2016 Review
Aetna Total ankle replacement 2015 Review
Aetna Total ankle arthroplasty in France 2010 Review
Aetna Current concepts in the management of ankle osteoarthritis: a systematic review 2015 Review
Aetna Total ankle arthroplasty: a long-term review of the London Hospital experience 1985 Review
Aetna Total ankle replacement: why, when and how 2010 Review
Aetna Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis 2006 Review
Aetna Cost-effectiveness analysis of total ankle arthroplasty 2005 Review
Aetna High revision and reoperation rates using the Agility™ total ankle system 2012 Review
Aetna Revision total ankle replacement: An early look at agility to INBONE 2011 Review
Aetna Total ankle arthroplasty in the rheumatoid patient 2010 Review
Aetna Management of failures of total ankle replacement with the agility total ankle arthroplasty 2013 Review
Aetna Ankle arthritis: review of diagnosis and operative management 2014 Review
Aetna Current concepts review: total ankle arthroplasty 2008 Review
Aetna Total ankle replacement 2003 Review
Aetna Total ankle arthroplasty versus ankle arthrodesis for the treatment of end-stage ankle arthritis: a meta-analysis of comparative studies 2016 Review
Aetna Total ankle arthroplasty with the Agility prosthesis: Clinical and radiographic evaluation 2006 Review
Aetna Modern total ankle arthroplasty versus ankle arthrodesis: a systematic review and meta-analysis 2020 Review
Aetna Posttraumatic ankle arthritis: an update on conservative and surgical management 2007 Review
Aetna Patient-specific instrumentation in total ankle arthroplasty 2022 Review
Aetna Post-operative management after total ankle arthroplasty: a systematic review of the literature 2022 Review
Aetna Total ankle arthroplasty 2011 Review
Aetna Avoiding and managing complications of the Agility Total Ankle Replacement system 2006 Review
Aetna Total ankle replacement revisited 2000 Review
Aetna Physical therapy management of patients with total ankle replacement 1980 Review
Aetna Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis 2005 Review
Aetna Total ankle replacement. Design evolution and results 2010 Review
Aetna The mid-term outcome of total ankle arthroplasty and ankle fusion in rheumatoid arthritis: a systematic review 2013 Review
Aetna A brief history of total ankle replacement and a review of the current status 2007 Review
Aetna Patient-specific instrumentation (PSI) in total ankle arthroplasty: a systematic review 2021 Review
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Cigna Total ankle replacement options 2019 Expert opinion
Cigna Consensus statement of the American College of Foot and Ankle Surgeons: diagnosis and treatment of ankle arthritis 2020 Expert opinion
Cigna Centers for Medicare and Medicaid Services (CMS). Local coverage determinations (LCDs) alphabetical index 2022 Government report
Cigna Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) alphabetical index 2022 Government report
Cigna US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Humanitarian Device Exemption (HDE) database. H200001. Patient specific talus spacer 2020 Miscellaneous
Cigna US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket approval (PMA). P050050. Scandinavian Total Ankle Replacement System (STAR Ankle) 2005 Miscellaneous
Cigna US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket Approval (PMA). P160036. The Hintermann Series H3™ total ankle replacement system 2016 Miscellaneous
Cigna Early clinical and radiographic outcomes of trabecular metal total ankle replacement using a transfibular approach 2018 Primary journal article
Cigna Trends and reported complications in ankle arthroplasty and ankle arthrodesis in the state of New York, 2009-2018 2018 Primary journal article
Cigna Fixed-bearing trabecular metal total ankle arthroplasty using the transfibular approach for end-stage ankle osteoarthritis: an international non-designer multicenter prospective cohort study 2022 Primary journal article
Cigna Intermediate-term results of total ankle replacement and ankle arthrodesis: a COFAS multicenter study 2014 Primary journal article
Cigna Outcomes of total ankle arthroplasty in moderate and severe valgus deformity 2018 Primary journal article
Cigna A controlled, comparative study of a fixed-bearing versus mobile-bearing ankle arthroplasty 2013 Primary journal article
Cigna Clinical outcome results of total ankle replacement and ankle arthrodesis: a pilot randomized controlled trial 2020 Primary journal article
Cigna Clinical outcomes of total ankle arthroplasty with total talar prosthesis 2019 Primary journal article
Cigna Early outcomes and radiographic alignment of the Infinity total ankle replacement with a minimum of two-year follow-up data 2018 Primary journal article
Cigna The Salto total ankle arthroplasty—clinical and radiological outcomes at five years 2019 Primary journal article
Cigna Total ankle arthroplasty incorporating a total talar prosthesis: a comparative study against the standard total ankle arthroplasty 2019 Primary journal article
Cigna Incidence and predictors of early complications following primary and revision total ankle arthroplasty 2018 Primary journal article
Cigna Total ankle arthroplasty versus ankle arthrodesis—a comparison of outcomes over the last decade 2017 Primary journal article
Cigna Comparison of intermediate-term outcomes of total ankle arthroplasty in primary and ligamentous post-traumatic osteoarthritis 2019 Primary journal article
Cigna Comparison of intermediate-term outcomes of total ankle arthroplasty in patients younger and older than 55 years 2019 Primary journal article
Cigna STAR™ ankle: long-term results 2011 Primary journal article
Cigna Mid-term prospective clinical and radiographic outcomes of a modern fixed-bearing total ankle arthroplasty 2019 Primary journal article
Cigna Patient-specific instrumentation in total ankle arthroplasty 2022 Primary journal article
Cigna Comparison of 25 ankle arthrodesis and 25 replacements at 67 months’ follow-up 2019 Primary journal article
Cigna Application of a customized total talar prosthesis for revision total ankle arthroplasty 2020 Primary journal article
Cigna Effectiveness and safety of ankle arthrodesis versus arthroplasty: a prospective multicenter study 2019 Primary journal article
Cigna Scandinavian total ankle replacement: 15-year follow-up 2018 Primary journal article
Cigna Are there differences in gait mechanics in patients with a fixed versus mobile bearing total ankle arthroplasty? A randomized trial 2017 Primary journal article
Cigna Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results 2009 Primary journal article
Cigna A three-year prospective comparative gait study between patients with ankle arthrodesis and arthroplasty 2018 Primary journal article
Cigna 3D printed total talar replacement: a promising treatment option for advanced arthritis, avascular osteonecrosis, and osteomyelitis of the ankle 2018 Primary journal article
Cigna Age, race, comorbidity, and insurance payer type are associated with outcomes after total ankle arthroplasty 2019 Primary journal article
Cigna An alumina ceramic total talar prosthesis for osteonecrosis of the talus 2015 Primary journal article
Cigna An alumina ceramic total talar prosthesis for avascular necrosis of the talus 2018 Primary journal article
Cigna Total ankle replacement: is pre-operative varus deformity a predictor of poor survival rate and clinical and radiological outcomes? 2018 Primary journal article
Cigna Outcomes of total ankle replacement, arthroscopic ankle arthrodesis, and open ankle arthrodesis for isolated non-deformed end-stage ankle arthritis 2019 Primary journal article
Cigna Effect of total ankle arthroplasty and ankle arthrodesis for ankle osteoarthritis: a comparative study 2019 Primary journal article
Cigna A randomized, controlled trial of two mobile-bearing total ankle replacements 2009 Primary journal article
Cigna Current concepts in the management of ankle arthritis 2020 Review
Cigna Complications following total ankle arthroplasty: a systematic literature review and meta-analysis 2022 Review
Cigna Outcomes following total ankle arthroplasty: a review of the registry data and current literature 2019 Review
Cigna Outcomes following total talus replacement: a systematic review 2022 Review
Cigna Total ankle arthroplasty versus ankle arthrodesis for the treatment of end-stage ankle arthritis: a meta-analysis of comparative studies 2016 Review
Cigna Modern total ankle arthroplasty versus ankle arthrodesis: a systematic review and meta-analysis 2020 Review
Cigna Comparison of the efficiency and safety of total ankle replacement and ankle arthrodesis in the treatment of osteoarthritis: an updated systematic review and meta-analysis 2020 Review
Cigna Outcome of ankle arthrodesis and ankle prosthesis: a review of the current status 2017 Review
Cigna Total ankle arthroplasty survivorship: a meta-analysis 2020 Review
Cigna Comparing 30-day all-cause readmission rates between tibiotalar fusion and total ankle replacement 2019 Review
Cigna Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis 2019 Review
Cigna A systematic review and meta-analysis of total ankle arthroplasty or ankle arthrodesis for treatment of osteoarthritis in patients with diabetes 2022 Review
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Cigna DT MedTech. Products, USA. ©2016-2022 Vilex LLC 2022 Website
Cigna Total joint replacement for severe rheumatoid arthritis 2022 Website
HCSC Current and emerging insight on total ankle replacement 2018 Expert opinion
HCSC Custom 3D-printed total talar prostheses restores normal joint anatomy throughout the hindfoot 2018 Primary journal article
HCSC Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature 2007 Primary journal article
HCSC Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty 2007 Primary journal article
HCSC Complications and failure after total ankle arthroplasty 2004 Primary journal article
HCSC Are there differences in gait mechanics in patients with a fixed versus mobile bearing trial 2017 Primary journal article
HCSC Total ankle replacement: the results in 200 ankles 2003 Primary journal article
HCSC Total ankle replacement: medium term results: in 200 Scandinavian total ankle replacements 2008 Primary journal article
HCSC STAR Ankle: long-term results 2011 Primary journal article
HCSC 257 ankle arthroplasties performed in Norway between 1994 and 2005 2007 Primary journal article
HCSC Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles 2011 Primary journal article
HCSC Total ankle replacement: the results of 100 mobility total ankle replacements 2010 Primary journal article
HCSC High rate of osteolytic lesions in medium-term follow-up after the AES total ankle replacement 2011 Primary journal article
HCSC Medium term follow-up of the AES ankle prosthesis: High rate of asymptomatic osteolysis 2009 Primary journal article
HCSC Ten-year evaluation of cementless BuechelPappas meniscal bearing total ankle replacement 2003 Primary journal article
HCSC Twenty-year evaluation of cementless mobile-bearing total ankle replacements 2004 Primary journal article
HCSC Total ankle arthroplasty in inflammatory joint disease with use of two mobile-bearing designs 2006 Primary journal article
HCSC Clinical outcomes of total ankle arthroplasty with total talar prosthesis 2019 Primary journal article
HCSC Advances in ankle replacement: a review 2014 Review
HCSC Current concepts review: total ankle arthroplasty 2008 Review
HCSC How successful are current ankle replacements? A systematic review of the literature 2009 Review
HCSC Incidence of revision after primary implantation of the Agility total ankle replacement system: a systematic review 2012 Review
HCSC Total ankle arthroplasty with the Agility prosthesis: clinical and radiographic evaluation 2006 Review
HCSC A systematic review of outcome and failure rate of uncemented Scandinavian total ankle replacement 2011 Review
HCSC Intermediate to long-term outcomes of the STAR Total Ankle Replacement: the patient perspective 2012 Review
HCSC 10-year survival of total ankle arthroplasties: a report on 780 cases from the Swedish Ankle Register 2011 Review
HCSC The Scandinavian total ankle replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventy-two consecutive patients 2013 Review
HCSC Ankle arthroplasty in patients younger and older than 50 years: a prospective series with long-term follow-up 1999 Review
HCSC The Salto Total Ankle Arthroplasty: survivorship and analysis of failures at 7 to 11 years 2011 Review
HCSC Total ankle replacement with use of a new three component implant 2011 Review
HCSC Eight-year results of a minimally constrained total ankle arthroplasty 2006 Review
HCSC American College of Foot and Ankle Surgeons (ACFAS). position statement on total ankle replacement surgery 2021 Society guideline
HCSC American Orthopaedic Foot & Ankle Society (AOFAS) position statement: the use of total ankle replacement for the treatment of arthritic conditions of the ankle 2021 Society guideline
HCSC Total ankle arthroplasty: a unique design. Two to twelve-year follow-up 1998 Unable to access
Highmark Position statement. The use of total ankle replacement for the treatment of arthritic conditions of the ankle. 2022 Miscellaneous
Highmark Perioperative complications of HINTEGRA total ankle replacement: our initial 50 cases 2008 Primary journal article
Highmark Short-term results of our first 49 Scandinavian total ankle replacements (STAR) 2008 Primary journal article
Highmark Total ankle replacement: medium-term results in 200 Scandinavian total ankle replacements 2008 Primary journal article
Highmark Clinical evaluation and radiographic assessment of bone lysis of the AES total ankle replacement 2009 Primary journal article
Highmark Intermediate term outcome of the agility total ankle arthroplasty 2009 Primary journal article
Highmark Long-term follow-up on 33 TPR ankle joint replacements in 26 patients with rheumatoid arthritis 2009 Primary journal article
Highmark Total ankle replacement in moderate to severe varus deformity of the ankle 2009 Primary journal article
Highmark Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results 2009 Primary journal article
Highmark A randomized, controlled trial of two mobile-bearing total ankle replacements 2009 Primary journal article
Highmark The Scandinavian total ankle replacement: survivorship at 5 and 8 years comparable to other series 2010 Primary journal article
Highmark Total ankle replacement by the Ankle Evolution System: medium-term outcome 2010 Primary journal article
Highmark Wound breakdown after total ankle arthroplasty 2010 Primary journal article
Highmark Evidence-based classification of complications in total ankle arthroplasty 2009 Review
Highmark How successful are current ankle replacements? A systematic review of the literature 2010 Review
Highmark Blue Cross Blue Shield Association Medical Policy Unable to access
Highmark InterQual Level of Care Criteria 2010 Unable to access
United Healthcare Position statement: the use of total ankle replacement for the treatment of arthritic conditions of the ankle. 2022 Miscellaneous
United Healthcare Total ankle replacement versus arthrodesis for end-stage ankle osteoarthritis: a randomized controlled trial 2022 Primary journal article
United Healthcare Comparing the results of total ankle arthroplasty vs tibiotalar fusion (ankle arthrodesis) in patients with ankle osteoarthritis since 2006 to 2020—a systematic review 2022 Review
United Healthcare Osteoarthritis in over 16s: diagnosis and management 2022 Society guideline
United Healthcare Osteoarthritis: care and management 2020 Society guideline
United Healthcare Joint distraction for ankle osteoarthritis 2015 Society guideline

Abbreviation: HCSC, Health Care Services Corporation.

Footnotes

Ethical Approval: Ethical approval was not sought for the present study because this manuscript did not involve human subjects research.

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Disclosure forms for all authors are available online.

Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD: Frank A. Petrigliano, MD, Inline graphic https://orcid.org/0000-0001-8816-6256

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

sj-pdf-1-fao-10.1177_24730114241239310 – Supplemental material for Evidence Guiding Commercial Payer Coverage Criteria for Total Ankle Arthroplasty

Supplemental material, sj-pdf-1-fao-10.1177_24730114241239310 for Evidence Guiding Commercial Payer Coverage Criteria for Total Ankle Arthroplasty by Jacob L. Kotlier, Amir Fathi, Meng-Yung Ong, Josh M. Yazditabar, Ethan E. Panoussi, Cory K. Mayfield, Frank A. Petrigliano, Joseph N. Liu, Alexander B. Peterson and Eric W. Tan in Foot & Ankle Orthopaedics


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