Covered without prior authorization (high confidence)
Documentation Required
Informed consent documentation that discusses limited long-term durability, complication and revision risks, and alternative (ankle arthrodesis) including potential impact on adjacent joints.
Device-specific requirements where applicable (e.g., manufacturer instructions for use, and, for STAR, participation in post-marketing surveillance as required by FDA — though this is manufacturer obligation, not patient documentation).
If infection is suspected intra-operatively, documentation of intra-operative cultures and any fresh frozen section (FFS) results if performed (FFS sensitivity/specificity discussed in background).
Studies used pre- and post-operative clinical and radiographic examinations (examples: VAS, AOFAS Ankle Hindfoot Score, SF-12, JSSF scale, FAOS) to document outcomes.
Key Coverage Criteria
Total ankle arthroplasty (TAA) using a Food and Drug Administration-cleared implant medically necessary when the following criteria are met: TAA is used to replace an arthritic or severely degenerated ankle
Member is skeletally mature
Member has moderate or severe pain with loss of ankle mobility and function
Arthritic or degenerated ankle is due to osteoarthritis (degenerative arthritis), post-traumatic arthritis and rheumatoid arthritis
Member has have failed at least 6 months of conservative management (including physical therapy, non-steroidal anti-inflammatory drugs, and orthoses as indicated)
End-stage ankle arthritis (end-stage ankle osteoarthritis/OA) — TAR/TAA as a treatment option
Radiological evaluation carried out on ankle radiographs in antero-posterior and lateral views, obtained in orthostasis, measuring parameters suggested by Hintermann (Infinity study).
For PSI and custom cutting guides: 'Cutting guides are customized with respect to each patient's anatomy based on pre-operative ankle computed tomography (CT) scans, and they drive the saw intra-operatively to improve the accuracy of bone resection and implant positioning.'