On July 29, 2021, the California insurance law firm Gianelli & Morris filed a class action complaint in the United States District Court for the Central District of California. The case is Brenda Honeycutt v. Anthem, Inc. (Case No.: 2:21-cv-6124). The complaint seeks benefits due under the insurance policy at issue, clarification of rights and future benefits, a class-wide injunction, and disgorgement of profits from the alleged wrongful denial of policy benefits, among other relief.

The complaint alleges that Anthem, Inc. and its subsidiaries improperly denied claims for surgery with Coflex, an interlaminar stabilization device to treat lumbar spinal stenosis.

According to court documents, lumbar spinal stenosis is a debilitating and degenerative disease affecting 1.6 million patients annually. The disease causes significant leg and back pain, numbness and weakness. Traditional surgical treatment options include decompression by removing bone and soft tissue, sometimes accompanied by a fusion of vertebrae to stabilize the spine.

Coflex is an “interlaminar stabilization device” that is inserted through a minimal incision to keep the decompressed area of the spine open and table. When combined with Coflex, decompression procedures are alleged to be more durable and sustainable, with patients less likely to need a reoperation or other future intervention. Court documents allege that Coflex obtains improved results over decompression alone, causes less trauma and a faster recovery period than fusion, and is not inferior to decompression with fusion.

Lawsuit Says Requests to Use Coflex Are Categorically Denied

Documents filed with the court allege that Anthem categorically denies all requests for Coflex as investigational and not medically necessary. Specifically, the plaintiffs’ complaint quotes from Anthem’s Medical Policy for Implanted Devices for Spinal Stenosis, SURG.00092, an internal company guideline that deems the use of Coflex “investigational and not medically necessary.”

According to the complaint, in denying Ms. Honeycutt’s request for Coflex, Anthem relied on its coverage guideline to say Coflex was not needed to keep the decompressed space open and to claim that not enough studies have been conducted to show Coflex is safe and effective. The complaint alleges that Anthem has a practice of relying on this guideline to deny all claims for Coflex without regard to the individual patient’s medical condition, need, or qualification for the device.

The complaint quotes from the plaintiff’s Anthem plan that defines an investigational procedure as one that lacks final approval from the appropriate government regulatory body, lacks credible scientific evidence published in peer-reviewed medical literature, has not been proven materially to improve the patient’s net health outcome, has not shown to be as beneficial as any established alternative, and has not shown improvement outside investigational settings.

In response to Anthem’s assertions of Coflex as investigational, the complaint alleges that Coflex is a Class III medical device approved by the FDA in 2012 through the agency’s premarket approval process that requires clinical human trials and numerous studies and investigations of the device’s safety and effectiveness. The complaint further alleges that Coflex has been the subject of additional peer-reviewed clinical studies, has received wide adoption by spine surgeons nationwide, and has garnered positive coverage recommendations from the International Society for the Advancement of Spine Surgery, the North American Spine Society, the American Pain Society and the National Institute for Health and Care Excellence.

Lead plaintiff’s attorney Rob Gianelli stated, “Anthem has denied necessary medical treatment for its members with serious back conditions who need surgery with Coflex. Despite the fact that surgery with Coflex has been FDA-approved for years, is recommended by top spine surgeons across the country, and frees patients from chronic pain and disability, Anthem categorically denies it as “investigational.” This class action lawsuit seeks to remedy that injustice.”

This class-action complaint is filed on behalf of all persons covered under ERISA health plans, self-funded or fully insured, that are administered by Anthem and whose claims for Coflex were denied on the basis the treatment is investigational and not medically necessary. The lawsuit seeks clarification that Coflex is covered and is not investigational or non medically necessary. The plaintiff further seeks a reevaluation of all the denied claims without the allegedly erroneous denial bases, along with a clarification of the members’ rights to future benefits. Plaintiff is also seeking a judicial order declaring that the denials at issue were wrong and improper and requiring Anthem to retract the allegedly erroneous medical policy language and notify all class members of the retraction. The lawsuit requests a surcharge in the form of an accounting and disgorgement of any profits made and retained through the improper denial of claims, along with payment of attorneys’ fees and such other equitable and remedial relief as the court may deem just and proper.