Aetna is alleging that Conformis joined a patient's denial-of-benefits lawsuit to compel coverage of its customized knee implants, which the insurer has deemed "experimental and investigational."
Aetna levied allegations of impropriety against Conformis in a July 23 motion to dismiss several counts outlined in a complaint by John Michael Schaub and Conformis. The allegations against Aetna are:
- Product disparagement/trade libel
- Tortious interference with contractual/business relationship
- Unfair trade practices/unfair competition
- Failure to pay claim for Employee Retirement and Income Security Act benefits
- Violation of fiduciary duties of loyalty and due care
- Denial of full and fair review in violation of ERISA
Mr. Schaub, a physical therapist assistant diagnosed with osteoarthritis, was scheduled to have a total knee replacement Feb. 18 at the recommendation of Boulder (Colo.) Bone and Joint's Michael Wertz, MD. Mr. Schaub and Dr. Wertz chose to move forward with a Conformis implant.
Aetna contracts with EviCore Healthcare to handle claims under the plan sponsored by Genesis HCC, Mr. Schaub's employer. Although Louisville, Colo.-based Avista Adventist Hospital, where Mr. Schaub's procedure was scheduled to take place, was believed to be in contact with both Aetna and EviCore in the weeks leading up to his surgery, neither gave any indication "that there was any issue with his choice of knee" until Feb. 10.
At that time, Dr. Wertz was notified that Aetna reversed authorization for Mr. Schaub's surgery due to policy No. 0660. This same policy covered Conformis' customized total knee implants for more than seven years before it was revised in September 2018 to deem those implants "experimental and investigational."
After exhausting "all avenues of appeal" to receive coverage for his knee replacement, Mr. Schaub had the procedure March 19, using the Conformis implant, Conformis said. He assigned Conformis the right to recover ERISA benefits from Aetna.
Additionally, Conformis alleged that Aetna's policy No. 0660 contains "false statements and assertions," making the implant-maker entitled to relief. Aetna, however, claims Conformis has no right to sue under the federal ERISA.
"This action is really an attempt by Conformis, a Massachusetts-based medical device manufacturer, to co-opt Mr. Schaub's ERISA denial of benefits claim and turn it into a quasi-class action to force Aetna to cover the Conformis custom total knee replacement device on a nationwide basis," Aetna said in its motion to dismiss. "ERISA is a federal statute with the express purpose of creating uniform rules for employee benefit plans; it is not a vehicle by which well-heeled medical device manufacturers can force insurers and ERISA-covered plans to pay for their products."
Click here to read the original complaint, and click here to view Aetna's motion to dismiss.