Updated: A Survey Of Health Care Anti-Kickback Law At The State Level

• Jurisdiction: United States,Federal
• Law Firm: Lowenstein Sandler
• Subject Matter: Food, Drugs, Healthcare, Life Sciences
• Author: Scott B. McBride, Jarrett R. Schindler, Rachel Moseson Dikovics, Marc L. Rein and Jessica M. Terry
• Published date: 21 April 2023

The federal health care Anti-Kickback Statute (Federal AKS) targets bribery and corruption in the health care industry. There are two core provisions of the Federal AKS: one targeting the bribe recipient and one targeting the bribe payer. Specifically, the statute prohibits receiving "any remuneration . . . in return for" health care referrals or purchases reimbursable under a federal health insurance program, such as Medicare.¹ And it prohibits paying any remuneration "to induce" health care referrals or purchases reimbursable under such a federal program.²

The Federal AKS is an incredibly far-reaching law giving federal enforcement agencies an arsenal of weapons to target questionable business arrangements in the health care industry. The term "remuneration" is defined open-endedly to mean "anything of value."³ And "anything of value" means just that: There is no de minimis remuneration under the Federal AKS.⁴ To prove a violation of the statute, the government need only demonstrate that one of the many possible purposes of paying remuneration was the inducement of the purchase of the federally reimbursable goods or services.⁵ Additionally, courts generally will not engage in a "splitting of hairs" when it comes to discerning the meaning of words such as "refer" and "recommend," relying instead on the broad, prophylactic purposes of the statute.⁶ Also, the plain language of the Federal AKS suggests that a quid pro quo is unnecessary for a payer of remuneration (i.e., a bribe payer) to violate the statute, raising the possibility that a health care company, provider, or individual could violate the statute simply by paying money to induce product usage, even if the recipient has not agreed to use the product in return for the money (i.e., even if the recipient of the "bribe" does not know he or she is being bribed).⁷

Given the expansive reach of the Federal AKS, there are a number of statutory and regulatory exceptions and "safe harbors" to the law. For example, the statute's restrictions do not apply to "a discount or other reduction in price" if a number of requirements are met.⁸ Likewise, "bona fide employment relationship[s]" are insulated from the statute's prohibitions,⁹ as are "personal services and management contracts,"¹⁰ as well as formal "referral services."¹¹ But even these safe harbors typically have numerous and cumbersome requirements, and if each such requirement is not strictly met, the conduct is subject to criminal prosecution or other...