Artificial disc replacement technology has advanced dramatically since the FDA approved it in 2004, and many surgeons laud the devices. However, it has its detractors.
Centinel Spine's Prodisc L is one popular device and is the only artificial disc approved in the U.S. for two-level replacement in the lumbar spine.
In recent months, the device has received strong support. The American Medical Association in November accepted a new CPT add-on code for the second level of lumbar total disc replacement procedures that will go into effect in 2023. In April, a third-party payer established coverage for one- and two- level lumbar disc replacement for patients in Utah and Idaho.
Another artificial disc, NuVasive's Simplify, was cleared in April 2021 by the FDA for two-level disc replacement in the cervical spine. Orthofix's M6-C disc has shown positive outcomes at the single level, and two-level trials started in August.
Artificial disc replacement has been lauded by payers and institutions, but Aetna is one prominent opponent.
In October, Aetna was ordered to face a 239-person class-action lawsuit related to its coverage lapse for lumbar disc replacement, and another lawsuit has been filed against the insurer. In both cases, Aetna denied coverage of artificial disc replacement, reasoning that it is "experimental and investigational."
Spine surgeons at the forefront of disc replacement are not buying that claim.
Jack Zigler, MD, and Richard Guyer, MD, are part of the medical team at the Texas Back Institute in Plano. The practice has performed artificial disc replacements for 22 years and recently marked its 3,000th lumbar disc replacement.
Dr. Zigler said FDA backing and thousands of global cases prove artificial discs are not experimental anymore.
"They're on really thin ice," Dr. Zigler said of Aetna. "It's really indefensible at this point for [Aetna] to say that it's experimental and investigational when it's been FDA approved since 2004. There have been almost 150,000 to 200,000 or more global implants already. So they're just posturing. Other insurance companies have tried to do the same thing, but they've had class-action lawsuits by patients who are more educated than the insurance company 'experts,' and those companies have all capitulated. They've all settled those cases on the eve of trial."
Dr. Guyer said he believes lawsuits will push Aetna to come around on its artificial disc coverage.
"It's only a matter of time before they crumble because they'll get tired of getting sued by patients that are good candidates for disc replacement that are forced to get fusions, when in reality they can have an operation that's much longer lasting compared to fusion," Dr. Guyer said. "We looked at all the lumbar artificial disc replacements that we did since March of 2000, and our revision rate is 1.5 percent."
It's unclear if or when Aetna will update their artificial disc coverage policy, but the market and technology will continue to grow. An April market report projected that the global artificial disc market will jump to $6.3 billion by 2027.
Aetna didn't immediately respond to an April 14 request for comment.