The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities, and laboratories. EKRA mostly mirrors the Anti-Kickback Statute (AKS) but extends its reach to commercial health insurance as well as federal programs like Medicare and Medicaid. Despite limited regulations and slow enforcement, some guidance emerged in 2025, though significant questions remain unresolved.
National Fraud Takedown and EKRA
EKRA drew some attention but generally remained a secondary focus. That changed in 2025, when an increase in allegations and indictments for EKRA violations occurred. During the 2025 National Fraud Takedown, several cases involved alleged breaches of both EKRA and the AKS. Kimberly Mable Sims, owner of a laboratory company, Francine Sims Super, office manager at a substance abuse treatment facility in North Carolina, and Keke Komeko Johnson, the Compliance Officer, were all indicted. In addition to accusations about gift cards, it was claimed that the substance abuse clinic routinely sent orders to Sims’s lab, which then performed urine drug tests on its patients and billed Medicaid. Allegedly, employees at the treatment center received kickbacks from the lab, while profits from referred specimens were equally split among the office manager, lab owner, and a biller. Earlier in 2025, Sims admitted guilt for EKRA violations. On August 25, 2025, Johnson and Super also pleaded guilty to paying kickbacks, resulting in a six-year sentence for Super.
Ninth Circuit Clarifies EKRA
In July 2025, in United States v. Schena, No. 23-2989 (9th Cir. July 11, 2025), the Court of Appeals for the Ninth Circuit upheld Mark Schena’s conviction for violating EKRA. Schena, who owned a laboratory, had paid marketing intermediaries to encourage referrals for questionable allergy tests. During the original trial, there was disagreement between Schena and the Department of Justice (DOJ) over how EKRA should be interpreted, particularly regarding whether the district court had correctly applied EKRA in S&G Labs Hawaii, LLC v. Graves, No. 1:2019cv00310 (D. Haw. 2021), aff’d, No. 24-823 (9th Cir. Jul 11, 2025) (unpublished).
The Ninth Circuit panel considered two main issues: (1) whether marketing intermediaries were covered by 18 USC § 220(a)(2)(A); and (2) if payments to these intermediaries constituted “inducement” under EKRA. The court concluded that marketing intermediaries who interact with ordering providers can fall under EKRA, further clarifying that payments do not have to go directly to the provider to violate EKRA. Finally, the court addressed the confusion created by the district court’s interpretation of EKRA was incorrect in S&G Labs Hawaii and realigned the Ninth Circuit’s reading of EKRA with other circuits’ approaches to the AKS.
Regarding what “to induce” a referral means, the Ninth Circuit found that simply paying percentage-based compensation is not automatically a violation of EKRA. There must be intent to improperly influence providers’ referrals through false or fraudulent means. However, the court did not define exactly which situations would show wrongful attempts to sway medical professionals’ decisions.
The case isn’t finished yet. Mark Schena has asked the United States Supreme Court to determine whether paying healthcare marketers a commission counts as “remuneration…to induce a referral” under EKRA. The Supreme Court has not yet decided whether it will hear the case.
Other Notable EKRA cases
A relator brought a False Claims Act case against a laboratory consortium of four interrelated companies (one investment firm and three executive), but the government declined to intervene. The relator has proceeded with the case, and the amended complaint alleges violations of the False Claims Act based, in part, on violations of EKRA and the AKS. It is alleged that the laboratory consortium paid sales representatives based on the volume and profitability of laboratory testing specimens based on a percentage of its reimbursement.
The laboratory consortium argued:
[U]nder Fifth Circuit precedent, Thompson’s allegations that defendants paid sales representatives volume- and profitability-based commissions is insufficient to plead a violation of the AKS and the EKRA, and Thompson must allege instead that the sales representatives improperly influenced the clinicians who sent samples to Apollo Labs and Arbor, such as by paying them a kickback or substituting their own judgment for that of the clinician.
U.S. ex. rel Thompson v. Apollo Path LLC, No. 3:20-cv-02917, Dkt. 77, at 8 (N.D. Tex. Mar. 5, 2025). The court agreed, relying on U.S. v. Marchetti¸ 96 F.4th 818(5th Cir. 2024), and stated:
In sum, a defendant’s payments to a third party to procure referrals from clinicians are made with the intent “to induce referrals” within the meaning of the AKS and the EKRA when there is evidence that the defendant intended for the third party to improperly influence the clinicians. Examples of improper influence include exploiting personal access and making the final decision about patient care.
Id. at 14. In April 2025, the Court dismissed both the federal and state law claims. Id., Dkt. 94 (Apr. 30, 2025).
Throughout 2025, there have been several indictments involving EKRA that have not necessarily involved laboratories but have been focused on substance abuse facilities, brokers, and marketing for sober homes and substance abuse facilities. A number of these actions are focused on California. See, e.g., United States v. Patton, No. 2:25-cr-00489 (C.D. Cal. June 17, 2025) (owner of a marketing company was indicted for allegedly referring patients with commercial health insurance to substance abuse treatment facilities); United States v. Mahoney, No. 8:21-cr-00183 (C.D. Cal. Mar. 21, 2025) (owner of addiction treatment facility sentenced to 41 months for violating EKRA) (appeal filed Mar. 2025); United States v. Simons, No. 3:25-cr-02444 (S.D. Cal. June 18, 2025) (CEO of multiple substance use disorder treatment facilities and sober homes was indicted for allegedly paying entities for marketing services). Each of these focus on payment that varies based on referral quotas, a lesson that can be instructive for clinical laboratories navigating EKRA too.
Conclusion
These recent developments in EKRA enforcement and judicial interpretation highlight the statute’s evolving scope and its increasing impact on laboratories, substance abuse facilities, and associated marketing practices.
- New Jersey expanded its patient brokering act to revise the law to specifically address substance user disorder treatment facilities and clinical laboratories. (Approved P.L. 2025, c.121).
- The Ninth Circuit clarified that EKRA can apply to payments made to sales representatives and that intent plays a critical role in determining whether such payments constitute improper inducement. However, Schena applied for certiorari at the Supreme Court.
- Texas dismissed a False Claims Act focusing on the lack of allegations regarding improper influence.
Ultimately, the trajectory of recent cases signals that both regulators and courts are committed to upholding the integrity of clinical decision-making and preventing undue influence through financial incentives.
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