Document Requests in Kickback Investigations

Document Requests in Kickback Investigations at a Glance

Document requests are a critical component of kickback investigations, especially in cases involving the Anti-Kickback Statute (AKS), the Eliminating Kickbacks in Recovery Act (EKRA), and related federal laws. These requests often seek to uncover evidence of illegal remuneration, referral patterns, and financial arrangements that may violate anti-kickback laws. Investigators and prosecutors rely on extensive documentation to build cases against individuals or entities alleged to have engaged in improper referral schemes.

The Legal Framework

The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), prohibits the knowing and willful offer, payment, solicitation, or receipt of remuneration to induce or reward referrals of items or services payable by a federal health care program. Violations can result in criminal penalties, including fines of up to $100,000 and imprisonment of up to 10 years.

31 U.S.C. §§ 3729–3733, the False Claims Act, provides a qui tam mechanism that allows private citizens to bring lawsuits on behalf of the government. A successful qui tam relator may receive between 15-25% of the proceeds if the government intervenes, 25-30% if it does not, and no more than 10% if the case is based primarily on public disclosures.

18 U.S.C. § 220, known as EKRA, expands the scope of anti-kickback prohibitions to include recovery homes, clinical treatment facilities, and laboratories. EKRA is an all-payor statute, meaning it applies to any health care benefit program, not just federal programs. Violations can result in fines of up to $200,000 and imprisonment of up to 10 years per occurrence.

Enforcement and Cases

Recent enforcement actions under these statutes highlight the seriousness with which federal authorities treat kickback violations. In United States v. Schena, No. 23-2989 (9th Cir. 2025), the Ninth Circuit affirmed the conviction of Mark Schena, operator of Arrayit, for paying marketers percentage commissions to induce laboratory referrals. Schena was sentenced to eight years in prison and ordered to pay over $24 million in restitution. This case marked the first federal appellate decision under EKRA.

Additionally, in 2024, clinical laboratory RDx Bioscience Inc. and its owner and CEO agreed to pay over $13 million to resolve allegations of volume-based commissions to marketers and disguised consulting and medical-director fees to induce laboratory referrals.

The Federal Overlay

The federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), makes it a felony to knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward referrals of items or services payable by a federal health care program. The Stark Law, 42 U.S.C. § 1395nn, separately prohibits physician self-referrals for designated health services payable by Medicare or Medicaid, on strict-liability terms. Both regimes carry safe harbors and exceptions published at 42 C.F.R. § 1001.952. State referral and fee-splitting statutes operate alongside these federal prohibitions and can apply even where no federal program payment is involved.

Reading the Research Desk

For further exploration, see related research topics including practice areas, an explanation of the AKS, safe harbors under the AKS, how AKS and Stark Law overlap, recent decisions, and FAQs.