Aetna’s Denial of ConforMIS Implants Results in Suit

ConforMIS, Inc. and John Michael Schaub, have sued Aetna, Inc. and Aetna Life Insurance Company (Aetna) alleging that Aetna wrongfully denied claims for the use of customized total knee implants for knee replacement patients.

Plaintiffs claim that Aetna violated its duties under the Employee Retirement Income Security Act (ERISA).

According to the complaint, Aetna, a healthcare insurance provider, administers Schaub’s employee-sponsored benefit plan. Schaub, a physical therapist, claims he was wrongfully denied coverage for his ConforMIS iTotal^® Knee Replacement System (ConforMIS System).

ConforMIS’ additional claims against Aetna include product disparagement, tortious interference with a contractual relationship, and unfair trade practices.

ConforMIS is a medical technology company that develops, manufactures, and sells customized joint replacement implants. Customized implants are individually sized and shaped to fit each patient. Its main product offering includes the ConforMIS System. The complaint claims the ConforMIS System received Food and Drug Administration (FDA) clearance on February 2, 2011 and has been used in over 100,000 patients.

Plaintiffs allege that for seven years following FDA clearance, Aetna covered the ConforMIS System for total knee replacement. They assert that at no time during this seven-year period did Aetna ever claim “the ConforMIS System to be ineffective, experimental, or investigational.”

On September 21, 2018, plaintiffs claim Aetna stopped covering customized total knee implants. Aetna purportedly revised its policy to describe customized total knee implants as “experimental and investigational because effectiveness has not been established.”

Plaintiffs argue that customized total knee implants are neither experimental nor investigational. In support of their position, plaintiffs provided a history of the ConforMIS System. In addition to FDA clearance, plaintiffs cite Aetna’s own prior approval of the ConforMIS System. Plaintiffs also claim other organizations and providers approve of the system including the American Associate of Hip and Knee Surgeons (AAHKS), United HealthCare, Cigna, and Anthem Blue Cross Blue Shield.

As of the date of this article Aetna had not filed a response.