Aetna sued for policy switch excluding customized knee implants

Angie Stewart -   Print  |

Aetna allegedly violated its duties under state law and the Employee Retirement Income Security Act by suddenly refusing to cover customized total knee implants, according to a lawsuit filed May 8 in the United States District Court for the District of Massachusetts.

In September 2019, Aetna revised Policy No. 0660 to exclude coverage for customized total knee implants, including the Conformis knee implant system. The revision deemed customized total knee implants "experimental and investigational because [their] effectiveness has not been established."

As a result, Aetna has been denying patients coverage for "medically necessary knee replacement services from Conformis," Conformis and Aetna beneficiary John Michael Schaub allege. For instance, Aetna allegedly denied coverage for Mr. Schaub's Conformis knee implant days before his scheduled procedure, despite having been aware of the surgery for months.

The plaintiffs allege Aetna's sudden decision to label customized implants as experimental is "inexplicable" and "unsupportable." Conformis also claims it has sustained "substantial" damages from Aetna's refusal to cover its knee system.

Aetna's website says "experimental services or procedures … are often newer drugs, treatments or tests. They are not yet accepted by doctors or by insurance plans as standard treatment. They may not be proven as effective or safe for most people," according to the lawsuit, which outlines reasons the Conformis implant doesn't fall under this category.

The FDA-approved Conformis System has been in use for several years, implanted in over 100,000 patients and endorsed by the American Association of Hip and Knee Surgeons, showing it is accepted by physicians and regulators, the lawsuit states.

Aetna also provided full coverage for the Conformis System for seven years after it gained FDA clearance, and at no point claimed that the system was ineffective, experimental or investigational, according to the lawsuit.

Today, Conformis implants are covered by more than 90 percent of commercial payers, including UnitedHealthcare, Cigna and Anthem Blue Cross Blue Shield, the plaintiffs allege. They also say many of the same studies cited as reasons for exclusion from Aetna's coverage are cited on Conformis' website as evidence that the company's implant is a proven and effective device.

Aetna's revised policy fails to explain why the FDA clearance, coverage by other payers, years of use and clinical research aren't enough to establish effectiveness of the implants — or what else is needed to make that determination, the plaintiffs allege.

Suing Aetna on six counts, the plaintiffs are seeking to recoup unpaid benefits, lost profits and other financial relief. They asked the court to deliver a judgment preventing Aetna from continuing to treat the Conformis system as experimental and investigational.

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