ARTICLE
13 September 2018

Vitality Of Employee Exemption To The Anti-Kickback Statute Reaffirmed

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Holland & Knight

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In Carrel v. AIDS Healthcare Found., Inc., No. 17-13185, 2018 WL 3734278 (11th Cir. Aug. 7, 2018), the Eleventh Circuit affirmed the dismissal of a whistleblower case brought under the federal FCA.
United States Food, Drugs, Healthcare, Life Sciences

Benjamin T. Tso is an Associate in Holland & Knight's Boston office

In Carrel v. AIDS Healthcare Found., Inc., No. 17-13185, 2018 WL 3734278 (11th Cir. Aug. 7, 2018), the Eleventh Circuit affirmed the dismissal of a whistleblower case brought under the federal FCA. The court found that the employee exemption to the AKS applied to payments that the defendant, the AIDS Healthcare Foundation (foundation), made to employees (linkage coordinators) to refer HIV patients to healthcare services offered by the foundation. The whistleblowers were three former employees of the foundation who sued the foundation under the FCA, alleging that the bonuses paid to the linkage coordinators were illegal kickbacks. The foundation is a nonprofit group that receives part of its revenue from federal healthcare programs, including Medicare and Medicaid. The foundation provides HIV testing, clinic and pharmacy services to patients with HIV/AIDS and matches HIV positive patients with healthcare providers.

In short, the whistleblowers alleged that the foundation paid some of its linkage coordinators a bonus on a per referral basis to refer HIV/AIDS patients to the foundation for healthcare service, and that these payments are prohibited "referral" payments under the AKS. The whistleblowers unsuccessfully tried to argue that referrals had to be made in a nondiscriminatory fashion, and that payments made solely for referrals were unprotected. The court held that under both the statutory exemption (42 U.S.C. §1320a-7b(b)(3)(B)) and the regulatory safe harbor (42 C.F.R. §1001.952(i)) regarding payments to employees in connection with providing goods or services covered by federal healthcare programs, the foundation was entitled to pay bonuses to its employees for referring patients to the foundation for healthcare services.

While the employee exception/safe harbor to the AKS traditionally has been applied to the model of compensating a sales force for a pharmaceutical or medical device company, the court's holding makes it clear that the employee exception/safe harbor has vitality in a much broader context. The court explained that the exemption covers "any amount paid by employer to an employee," even when certain practices were "unwise or improper."

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