Aetna Denies Insureds L-ADR Surgery Class Action

At issue in this class action are certain policies of the health insurance offered by Aetna Life Insurance Company. The complaint alleges that Aetna will not pay for its insureds to have lumbar artificial disc replacement (L-ADR) surgery, alleging that it is “experimental and investigational.” But the complaint claims that this is not true, that the Food and Drug Administration (FDA) approved L-ADR fifteen years ago, and that this surgery is a safe procedure that may even be the recommended treatment.

Traditionally, the complaint claims, when a patient had degenerative lumbar disc disease, the recommended treatment was a spinal fusion, which was not entirely satisfactory. Fusion, it says, interfered with the patient’s mobility at that level, which put more stress on the surrounding disc levels, which raised the risk of herniation or disease at those levels.

However, the complaint alleges that when L-ADR is performed, “the diseased disc is replaced with an artificial disc that maintains the integrity of the disc space while providing the flexibility of a natural disc.”

Since 2004, the FDA has approved various discs for this surgery, including the Charité Artificial Disc, the ProDisc-L, and the activL, which received Premarket Approval in 2015.

These artificial discs are Class III medical devices, which present risks to health, so they must meet what the complaint calls “the FDA’s most stringent safety standards before they are approved for commercial sale or distribution. These include sufficient controlled clinical trial evidence to ensure that a given device is safe and effective.”

According to the complaint, peer-reviewed articles on controlled clinical trials have established that the procedure is safe and effective if done with an FDA-approved device. It has been done thousands of times, the complaint alleges, and “[a]ll major health insurers other than Aetna (Anthem, United HealthCare, Humana, Cigna) cover the surgery.”

However, the complaint alleges, Aetna’s policy is to deny this procedure to its insureds, claiming it is “experimental and investigational for lumbosacral degenerative disc disease and for all other indications.”

It therefore has refused this procedure to the plaintiff in this case, Andrew Howard. Howard suffers from disc disease at a certain level of his spine, and his doctor recommended the L-ADR surgery for him, but the complaint claims that Aetna has refused to authorize it, claiming, among other things, “Clinical studies have not proven that this service is effective for treatment of the member’s condition.” In the end, Howard paid for the procedure himself.

The complaint refers to another case against Aetna and California law to define Aetna’s position on claims like Howard’s.

The class for this action is all persons covered by Aetna plans, governed by the Employee Retirement Income Security Act (ERISA), and subject to a de novo standard of review, whose requests for lumbar artificial disc replacement surgery were denied at any time within the applicable statute of limitations, or whose requests for that surgery will be denied in the future, on the grounds that the surgery is experimental or investigational.

Article Type: Lawsuit
Topic: Insurance
Tags: Denial of Benefits, Health Insurance, Insurance