Total Ankle Arthroplasty denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a 55-year-old male with bilateral ankle arthritis. He underwent left ankle debridement is 2002. The patient has been evaluated by multiple providers who have recommended ankle arthroplasty over fusion. The Health Plan indicates there is insufficient scientific evidence supporting the safety and efficacy of the requested procedure. Therefore, the Health Plan has determined the requested procedure is considered experimental. The standard of care for the surgical treatment of severe osteoarthritis of the ankle joint is fusion therapy. This is clearly and thoroughly supported in the literature. Additionally, the results of ankle fusion are very good for pain relief and restoration of function.

A 63-year-old male enrollee has requested total ankle arthroplasty for the treatment of his end stage arthritis of the right ankle. Findings: Two physician reviewers found that total ankle arthroplasty is approved by the FDA for the treatment of arthritis. Review of the scientific literature demonstrates that the results of total ankle arthroplasty with respect to pain relief are equivalent to the results of ankle fusion, with lower incidence of side effects. Ankle fusion often leads to the development of arthritis in surrounding joints, such as the talonavicular joint and the subtalar joint. This patient's treating physician has already noted that the patient has pain and restricted motion in the subtalar joint and radiographic evidence of early arthritis within the subtalar joint. Ankle fusion is likely to exacerbate the patient's painful subtalar arthrosis and hasten its progression.

Where the denial was upheld

A 55-year-old female enrollee has requested for right total ankle replacement surgery for treatment of her advanced post-traumatic osteoarthritis. Findings: Two physician reviewers found that this patient is not likely to benefit from total ankle arthroplasty as compared to ankle arthrodesis in management of her post-traumatic degenerative osteoarthritis of the ankle. This decision is based upon review of the literature including the study by Saltzman and colleagues, in which the STAR total ankle replacement was studied versus ankle fusion over a two-year period of time. While ankle fusion affects the heel strike and foot flat portion of the gait, there is no discussion as to the efficacy of orthotics in compensating for the negative functional aspects of an ankle arthrodesis.

A 56-year-old female enrollee has requested left total ankle arthroplasty for the treatment of her end stage post-traumatic arthritis. Findings: Three physician reviewers found that the medical literature lacks long-term, controlled double-blind studies validating the safety and efficacy of this procedure. While preliminary studies suggest promise for total ankle arthroplasty, without peer-reviewed literature in support of the procedure, its efficacy remains unproven. SooHoo and colleagues state that, “This study confirms that, compared with ankle fusion, ankle replacement is associated with a higher risk of complications but also potential advantages in terms of a decreased risk of the patient requiring subtalar joint fusion.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Total Ankle Arthroplasty, then check the rights and deadlines that apply to your plan.