On September 25, 2026, the United States Department of Justice (DOJ) rejected a petition from the American Clinical Laboratory Association (ACLA) requesting that the Attorney General promulgate regulations through rulemaking for the Eliminating Kickbacks in Recovery Act , 18 U.S.C. § 220 (EKRA), regarding certain arrangements with employed marketing personnel. See DOJ; Response to Correspondence Requesting Rulemaking, 91 Fed. Reg. 60,905, 60,906 (Sept. 25, 2026). Specifically, in September 2024, the ACLA requested that the DOJ promulgate regulations providing that EKRA permits a laboratory or other employer to provide remuneration in any manner (including variable compensation) to a sales representative that it employs, provided that the employee does not knowingly and willfully provide materially false or misleading information to health care providers or patients.
As background, EKRA is a health care fraud and abuse statute established to prohibit certain types of patient brokering arrangements related to services provided to vulnerable individuals with substance use disorders during the opioid epidemic. EKRA prohibits a person from knowingly and willfully soliciting or receiving any remuneration in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory with respect to services covered by a health care benefit program (i.e., either a commercial health insurance plan or a federal health program). EKRA also prohibits a person from paying or offering, with respect to services covered by a health care benefit program, any remuneration (i) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory, or (ii) in exchange for an individual using the services of a recovery home, clinical treatment facility, or laboratory. Each violation of EKRA could result in a $200,000 fine or a ten-year prison sentence.
EKRA has seven statutory exceptions and no regulatory exceptions. EKRA permits the Attorney General, in consultation with the Secretary of Health and Human Services, to promulgate safe harbor regulations for other types of payment arrangements. See 18 U.S.C. § 220(b)(8).
The DOJ declined the ACLA's petition to promulgate EKRA rulemaking for several reasons. First, the DOJ explained that the requested EKRA regulation would limit the scope of EKRA to apply only in situations that involve the knowing and willful provision of false information which, the DOJ noted, would set a high bar for enforcement where clinical laboratories "intentionally implement commission-based payment systems to directly reward referrals."
Second, the DOJ observed that the requested EKRA regulation would be contrary to current legal precedent regarding EKRA, which acknowledges that paying sales representatives percentage-based compensation and directing such sales personnel to provide misleading information is a sufficient set of circumstances to establish a violation of EKRA, but "is not a necessary set of circumstances…although it is sufficient." See United States v. Schena, 142 F.4th 1217, 1226 (9th Cir. 2025).
Third, the DOJ explained that the ACLA's proposed EKRA exception misinterprets the central purpose of EKRA. EKRA is designed to prevent financial incentives that could compromise clinical decision-making and patient care, and arrangements that implicate EKRA could be harmful because they could limit patient choice, promote unfair competition, and cause overutilization of health care items and services.
The DOJ further rationalized that, under EKRA, laboratories may compensate employed sales personnel in a manner that does not reward referrals and that the "laboratory industry also has operated successfully under similar Anti-Kickback Statute restrictions for variable compensation" related to traditional federal health care programs for decades. The DOJ ignores the inconsistency between the bona fide employment safe harbor under the Anti-Kickback Statute and the current EKRA framework related to compensation structures that are permissible under the Anti-Kickback Statute for bona fide employees.
Important Takeaways
There are two important takeaways regarding the DOJ's decision to decline ACLA's petition to issue EKRA regulations. The first important takeaway is that the DOJ embraces a broad interpretation of EKRA consistent with the text of the statute that is not limited to situations that involve marketing personnel who engage in the knowing and willful provision of misleading information. The second important takeaway is that the DOJ endorses the idea that the purpose of EKRA is to prevent financial incentives and payment arrangements that could compromise patient care.
Though no EKRA regulations appear to be forthcoming, this decision by the DOJ is a reminder that clinical laboratories, treatment centers, and recovery homes should review their compensation arrangements with employed sales representatives to ensure compliance with EKRA.
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For more information about the DOJ's decision or how EKRA may affect your organization's compensation arrangements, please contact Alissa D. Fleming, Bernard Miller, or any other member of Baker Donelson's Health Law Group.