Becker's ASC Review

40 ORTHOPEDICS Aetna sued for policy switch excluding customized total knee implants By Angie Stewart A etna allegedly violated its duties under state law and the Employee Retirement Income Security Act by suddenly refusing to cover customized total knee implants, according to a lawsuit filed May 8 in the United States District Court for the District of Massachusetts. In September 2019, Aetna revised Policy No. 0660 to exclude coverage for customized total knee implants, including the Conformis knee implant system. e revision deemed customized total knee implants "experimental and investigational because [their] effective- ness has not been established." As a result, Aetna has been denying patients coverage for "medically necessary knee replacement services from Conformis," Con- formis and Aetna beneficiary John Michael Schaub alleged. For instance, Aetna allegedly denied coverage for Mr. Schaub's Confor- mis knee implant days before his scheduled procedure, despite having been aware of the surgery for months. e plaintiffs alleged Aetna's sudden decision to label customized implants as experimental is "inexplicable" and "unsupportable." Con- formis also claims it has sustained "substan- tial" damages from Aetna's refusal to cover its knee system. Aetna's website says "experimental services or procedures … are oen newer drugs, treatments or tests. ey are not yet accepted by doctors or by insurance plans as standard treatment. ey may not be proven as effec- tive or safe for most people," according to the lawsuit, which outlines reasons the Confor- mis implant doesn't fall under this category. e FDA-approved Conformis System has been in use for several years, implanted in over 100,000 patients and endorsed by the American Association of Hip and Knee Sur- geons, showing it is accepted by physicians and regulators, the lawsuit states. Aetna also provided full coverage for the Conformis System for seven years aer it gained FDA clearance, and at no point claimed that the system was ineffective, experimental or investigational, according to the lawsuit. Today, Conformis implants are covered by more than 90 percent of commercial payers, including UnitedHealthcare, Cigna and Anthem Blue Cross Blue Shield, the plaintiffs alleged. ey also say many of the same stud- ies cited as reasons for exclusion from Aetna's coverage are cited on Conformis' website as evidence that the company's implant is a proven and effective device. Aetna's revised policy fails to explain why the FDA clearance, coverage by other pay- ers, years of use and clinical research aren't enough to establish effectiveness of the im- plants — or what else is needed to make that determination, the plaintiffs alleged. Suing Aetna on six counts, the plaintiffs are seeking to recoup unpaid benefits, lost profits and other financial relief. ey asked the court to deliver a judgment preventing Aetna from continuing to treat the Conformis sys- tem as experimental and investigational. n Walmart Health expands as physician practices face cash crunch By Ayla Ellison W almart is moving deeper into the primary care market while physician practices across the country are struggling to stay afloat. Since September, Walmart Health has opened two standalone clinics. One in Dallas, Ga., and another in Calhoun, Ga. This summer, Walmart Health clinics will open in Loganville, Ga., and Newnan, Ga., and the company received approval in late April from the Fayetteville (Ga.) Plan- ning and Zoning Commission to build a 6,500-square-foot clinic, according to The Citizen. Walmart Health is opening more clinics, which offer a variety of services, ranging from primary care to labs to dental, in one facility, while primary care prac- tices are facing financial damage caused by the COVID-19 pan- demic. In mid-April, 20 percent of primary care practices pre- dicted they would close within a month, and nearly half of those surveyed were unsure if they had enough cash to remain open. With more than 5,000 stores and clubs nationwide, Walmart has the potential to upend the way many Americans receive medical care. Walmart wants physicians at its health centers to replace patients' current primary care providers, Marcus Osborne, Walmart's Vice President of Health and Wellness Transfor- mation, told CNN Business in March. n In September 2019, Aetna revised Policy No. 0660 to exclude coverage for customized total knee implants, including the Conformis knee implant system.

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