judge gavel lawsuit medtech medical device Conformis Aetna

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Joint replacement implant maker Conformis (NSDQ:CFMS) is improperly using a Colorado man’s denial of benefits lawsuit to force Aetna to cover its customized knee implants, the health insurer recently argued in a federal court filing.

Billerica, Mass.-based Conformis joined John Michael Schaub of Golden, Colo., in his lawsuit against Aetna, filed in May in U.S. District Court in Massachusetts.

The lawsuit, according to Aetna’s lawyers, turns the federal Employee Retirement and Income Security Act on its head.

“Conformis is a Massachusetts-based medical device manufacturer that has no rights or standing to sue under ERISA. The complaint is Conformis’ novel, but improper, attempt to co-opt Mr. Schaub’s ERISA denial of benefits claim, and convert that claim into something it is not: a quasi-class action intended to force Aetna to cover the Conformis custom total knee replacement device nationwide under Aetna’s commercial health insurance benefits plans,” Aetna’s attorneys at Nixon Peabody and Groom Law Group said in their July 23 motion to dismiss most of the suit.

Conformis in its complaint with Schaub said that it has sustained substantial damages since Aetna in September 2018 declared a new policy that “without warning and for no apparent reason” excluded coverage for customized total knee implants under its health plans and the ones it administers.

Aetna, according to Conformis, misrepresented to physicians and patients that Conformis’ products and the Conformis System are “experimental and investigational.”

Since FDA cleared Conformis implants in 2011, more than 100,000 people have received them, with efficacy well-established, according to Conformis. The Centers for Medicare and Medicaid Services, United Healthcare, Cigna, Anthem Blue Cross Blue Shield and other carriers cover the Conformis system. “Thus, Aetna’s sudden decision to declare the Conformis system ‘experimental’ or ‘investigational’ is as inexplicable as it is unsupportable,” Conformis and Schaub’s attorneys at K&L Gates said in the complaint.

The complaint added: “If Aetna’s conduct is allowed to continue, it threatens irreparable harm to Aetna as well as the patients who depend upon the services Conformis provides.”