Becker's ASC Review

18 ORTHOPEDICS Aetna revises lumbar disc replacement policy By Carly Behm Aetna updated its Clinical Policy Bulletin Feb. 8 following a class- action settlement related to its lumbar disc replacement coverage. e new review said FDA-approved total disc implants are "medically necessary" for treating lumbar degenerative disc disease at one level under certain criteria. Criteria for coverage include being 18 to 60 years old, having failed conservative treatment for at least six months, and confirmation of single-level disease through imaging. is change comes just over two months aer Aetna settled a 239-person class-action lawsuit calling out the insurer's coverage policy previously labeling lumbar disc replacement as "experimental and investigational." Lumbar partial disc prosthetics and multilevel lumbar disc replacement still have that label, according to Aetna's policy. Jack Zigler, MD, a spine surgeon at Plano-based Texas Back Institute, told Becker's he was happy with the update. "As a clinician intimately involved in the evolution of disc arthroplasty, it is gratifying to see that Aetna has finally recognized the value of lumbar disc replacement for the appropriately-indicated patient," Dr. Zigler said. "A strong database collected over the past 20 years has consistently demonstrated the value of this technology in improving outcomes in these patients over fusion or continued conservative care." Scott Blumenthal, MD, who performed the first disc replacement in the U.S. at TBI, said while the update is important, he wished Aetna would follow other insurers and cover two-level lumbar disc replacement. "I think obviously it's a good thing," Dr. Blumenthal said. "[e update] took way, way, way too long, and it's unfortunate that it took a class-action lawsuit to confirm what we have of 20 years-plus of really good science. I am disappointed that they ignored two-level lumbar disc replacement, which has just as good data. … [Aetna] wrote a very cookie-cutter, straight off the one-level trial criteria. What I found is there's a lot more gray-zone patients than perfect FDA trial patients, and it's going to be [important how] they enforce some of the gray- zone stuff." Richard Guyer, MD, a spine surgeon at TBI, said the change was a long time coming as the practice enters its 23rd year of performing lumbar disc replacement. "Now Aetna is almost on even ground with the other major insurance carriers but is still behind as many of them are now paying for 2-level lumbar disc replacement," Dr. Guyer said. "I feel most badly for those patients who were denied this treatment and ended up having fusion. We now consider all patients with degenerative disc disease as candidates for lumbar TDR and look for reasons why they may not be." Jessica Shellock, MD, a spine surgeon performing total disc replacement at TBI, said the policy change would benefit patients' access to the procedure. "It's a shame that it took a class-action lawsuit to finally get this addressed but, at the same time, it shows that there is power when patients rally together and finally make their voices heard," Dr. Shellock said. n Stryker has ambitious robotics plans. Here's how 2 competitors are responding By Carly Behm I n its fourth quarter earnings call, Stryker laid out its timeline for new Mako robot applications. Since, executives at other medtech companies have addressed those plans. Stryker's vice president of investor relations, Jason Beach, said there is "good progress" on Mako spine and shoulder's development, according to a Jan. 31 call transcribed by Seeking Alpha. Mako spine is expected to launch in the second half of 2024, and the initial shoulder launch is aimed toward the end of 2024. A few days later, Zimmer Biomet's COO Ivan Tornos said the company expects to beat Stryker to the shoulder application. Mr. Tornos didn't give specifics but said a launch could be soon. "I'll tell you frankly, I'll be very surprised if we're not first to market, given where we are in the development cycle," Mr. Tornos said, as transcribed by Seeking Alpha. "My expectation remains that we're going to be ahead." Globus Medical, which has its ExcelsiusGPS and Excelsius3D spine systems, also has its eye on Stryker. In its Feb. 21 fourth quarter earnings call, CEO Dan Scavilla said he wasn't worried about competition with Stryker. "We've been talking continuously about our development of the ecosystem of multiple things that all fit together," Mr. Scavilla said, as transcribed by Motley Fool. "We've talked about our procedural applications from pre-op planning through to post-op data and feedback loops. All of those items were well ahead of the curve. We're pushing out. We're driving. That will not only keep us relevant but actually keep us as a leader here. Competition will come as natural. They're coming because of our success, and we're going to continue to innovate." n

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