Becker's ASC Review

25 ORTHOPEDICS 'They're on really thin ice': Why 1 insurer has drawn spine surgeons' ire By Carly Behm A rtificial disc replacement technolo- gy 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 ap- proved in the U.S. for two-level replace- ment in the lumbar spine. In recent months, the device has received strong support. e American Medical As- sociation 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 cervi- cal 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 replace- ment, and another lawsuit has been filed against the insurer. In both cases, Aetna denied coverage of artificial disc replace- ment, 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. e 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. "ey're on really thin ice," Dr. Zigler said of Aetna. "It's really indefensible at this point for [Aetna] to say that it's experi- mental and investigational when it's been FDA approved since 2004. ere 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. ey'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 artifi- cial 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. n Johnson & Johnson orthopedics wants to be more competitive in ASCs By Laura Dyrda J ohnson & Johnson plans to step up its focus on the ASC market as surgery centers become a larger part of the healthcare ecosystem, Ashley McEvoy, executive vice president and worldwide chair of medical devices, said April 19 during the company's first-quarter earnings call. Ms. McEvoy said the company's ASC penetration is still relatively low at less than 20 percent, but it's quickly growing. "In a COVID environment, we've seen the model evolve to create a safe, more patient-friendly experience that addresses a patient sentiment of not wanting to go to a hospital setting," she said on the call, as transcribed by The Motley Fool. "Certain procedures have gone there early, sooner than later. … We've done a lot of work recently to modify our business model to make it a capital-efficient flow, if you will, in inventory management, on the personalization of care using digital assets [to make the] pre-op and post- op experience less full of friction." The company is particularly focused on bringing its orthopedics business into ASCs. During the first quarter, worldwide orthopedics grew 5.6 percent amid the recovery from COVID-19 and continued adoption in surgery centers. Ms. McEvoy said the company's strong performance in the hip and knee markets was partially due to expanding to new sites such as ASCs. Johnson & Johnson also launched enhancements to its Velys hip navigation and robotic-assisted solution, and the Attune knee system. Johnson & Johnson is also taking its experience at U.S.-based ASCs to China in the tier 2 and tier 3 cities for care delivery. n

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