Anti-Kickback Statute Defense: Federal Healthcare Kickback Charges Explained

By Elizabeth Franklin-Best, Esq., and Christopher Zoukis, JD, MBA

The federal Anti-Kickback Statute turns ordinary-looking business arrangements — a medical directorship, a lease, a consulting agreement, a marketing contract — into potential felonies whenever federal health care dollars are involved. If you are a physician, pharmacy owner, lab operator, device representative, or health care executive under investigation, the time to bring in an anti-kickback statute lawyer is before you explain anything to anyone — these cases turn on intent, and intent is fought line by line. At Elizabeth Franklin-Best, P.C., we defend clients against AKS allegations across the country.

The Anti-Kickback Statute, codified at 42 U.S.C. § 1320a-7b(b), is one of the most aggressively enforced criminal laws in American health care. The Department of Justice, the Department of Health and Human Services Office of Inspector General, and dozens of Medicare Fraud Strike Force teams use it to prosecute conduct that defendants often believed was lawful — and the statute reaches both sides of every transaction, the payer and the recipient alike.

Our firm brings a federal-court defense practice grounded in detailed statutory analysis and controlling case law. Elizabeth Franklin-Best is a federal criminal and appellate attorney whom Best Lawyers in America selected as the 2026 “Best Lawyer” in Appellate Practice; the firm also carries a 2026 Chambers USA ranking in Litigation: White-Collar Crime & Government Investigations. Our team approaches every kickback case by mapping each element the government must prove and testing whether the evidence actually reaches it. If you are facing scrutiny under the Anti-Kickback Statute, we invite you to schedule a paid, one-hour initial consultation to discuss your situation.

Anti-Kickback Statute: Quick Answer

Question	Answer
What is the Anti-Kickback Statute?	A federal criminal law, 42 U.S.C. § 1320a-7b(b), that bars knowingly and willfully paying or receiving anything of value to induce referrals or the purchase of items or services covered by a federal health care program.
What must the government prove?	That the defendant knowingly and willfully solicited, received, offered, or paid remuneration, and that at least one purpose was to induce a referral or the ordering of federally reimbursable health care items or services.
What penalties can apply?	Up to 10 years in federal prison and a fine of up to $100,000 per violation, plus mandatory exclusion from Medicare, Medicaid, and all federal health care programs.
Is intent required?	Yes. The AKS is a specific-intent crime requiring willful conduct, though the government need not prove the defendant knew of the statute itself.
How do we start?	Through a paid, hour-long initial consultation examining the arrangement under scrutiny — the contract, the compensation, the referral pattern — and the defenses realistically available.

Key Takeaways

• The Anti-Kickback Statute criminalizes both sides of a transaction — the party who offers or pays and the party who solicits or receives.
• “Remuneration” is interpreted broadly: cash, above-market salaries, free rent, discounted services, gifts, and many other things of value can qualify.
• Under the “one purpose” test, an arrangement can violate the statute even if it also served legitimate business purposes, so long as one purpose was to induce referrals.
• The AKS is a criminal, intent-based statute; the Stark Law is a separate civil, strict-liability law that governs physician self-referral.
• A 2010 amendment confirmed that the government does not have to prove the defendant knew the Anti-Kickback Statute existed.
• Statutory exceptions and regulatory “safe harbors” can protect properly structured arrangements, but a near-miss provides no protection.
• An AKS violation can also trigger False Claims Act liability, transforming a criminal exposure into parallel civil and whistleblower litigation.
• Early, careful defense work — before charges are filed — often shapes whether a matter becomes a criminal case at all.

What Is the Anti-Kickback Statute?

The Anti-Kickback Statute is a federal criminal law that prohibits the knowing and willful exchange of anything of value to influence the referral of business reimbursable by a federal health care program. Congress enacted it to protect patients and federal programs from medical decisions driven by financial self-interest rather than clinical judgment. Medicare, Medicaid, TRICARE, and the Department of Veterans Affairs health system all fall within its reach.

The statute is unusually broad. It covers anyone who “solicits or receives” remuneration and, separately, anyone who “offers or pays” it. That means a physician who accepts a payment and the company that made it can both be prosecuted from the same set of facts. The law also reaches indirect arrangements — payments routed through intermediaries, shell entities, or layered contracts are not insulated simply because the money took an indirect path.

Enforcement has expanded steadily. The Department of Justice pairs the Anti-Kickback Statute with the False Claims Act, the health care fraud statute, and money laundering counts to build large, multi-defendant indictments. Laboratories, pharmacies, hospices, durable medical equipment suppliers, telemedicine platforms, and substance abuse treatment centers have all drawn intense federal attention. Understanding where your conduct sits within this framework is the first step in building a defense.

What the Government Must Prove

To convict under 42 U.S.C. § 1320a-7b(b), the government must establish that the defendant (1) knowingly and willfully (2) solicited, received, offered, or paid remuneration (3) to induce a referral, or to induce the purchasing, leasing, ordering, or arranging for any good, facility, service, or item (4) for which payment may be made in whole or in part under a federal health care program. Each element is a separate point of attack.

The “Knowingly and Willfully” Standard

The Anti-Kickback Statute is a specific-intent crime. Courts have described “willfully” as acting voluntarily and purposely, with the specific intent to do something the law forbids — that is, with a bad purpose. A genuine, good-faith belief that an arrangement was lawful is therefore directly relevant to the willfulness element and is often the heart of the defense.

Importantly, a 2010 amendment to the statute settled a long-running dispute among the federal circuits. The law now provides that a person need not have actual knowledge of the Anti-Kickback Statute, or specific intent to violate that particular statute, to be convicted. The government must still prove willful, wrongful conduct — but it does not have to prove the defendant had read or knew of the statute itself. Defense strategy must account for this distinction precisely.

The “One Purpose” Test

Many AKS cases rise or fall on the “one purpose” test. Federal courts, beginning with the Third Circuit’s decision in United States v. Greber, 760 F.2d 68 (3d Cir. 1985), have held that an arrangement violates the statute if even one purpose of a payment is to induce referrals — even when the payment also compensates for genuine, valuable services. In Greber, the court upheld a conviction where “interpretation fees” paid to referring physicians were partly legitimate compensation and partly an inducement.

This doctrine is why a defensible-looking contract is not automatically safe. A consulting agreement, medical directorship, or lease can carry real value and still expose the parties to liability if the government can persuade a jury that a referral motive was woven into it. A capable defense scrutinizes the evidence of purpose: contemporaneous documents, the commercial reasonableness of the terms, fair-market-value analysis, and the actual business need the arrangement met.

Applied Insight: Because the “one purpose” test allows a partly legitimate arrangement to be charged, the contemporaneous record matters enormously. Fair-market-value opinions, written business justifications, and documented need created at the time an arrangement is formed — not reconstructed afterward — are frequently the most persuasive evidence a defense can present.

The Anti-Kickback Statute vs. the Stark Law

The Anti-Kickback Statute is frequently confused with the Stark Law, the federal physician self-referral law at 42 U.S.C. § 1395nn. They overlap in subject matter but differ in critical ways, and the difference shapes both exposure and defense.

The Anti-Kickback Statute is a criminal law. It requires willful intent, applies to referrals of any federally reimbursable item or service, and reaches anyone — physicians, marketers, suppliers, executives. The Stark Law, by contrast, is a civil, strict-liability statute. It applies only to physician referrals for designated health services, requires no proof of intent, and carries civil penalties and repayment obligations rather than prison time. A technical Stark violation can occur with no wrongful state of mind at all.

In practice, the same arrangement can implicate both laws at once, and federal prosecutors often investigate them together. When a matter carries criminal exposure, the Anti-Kickback Statute is almost always the dominant concern, because it is the path to indictment and imprisonment. Sorting out which law actually applies — and how seriously — is one of the first things a defense should do.

What Counts as “Remuneration”

The statute prohibits “any remuneration,” and Congress chose that phrase deliberately to reach beyond simple cash kickbacks. Courts have recognized that the 1977 addition of the word “remuneration” broadened a law that previously addressed only kickbacks, bribes, and rebates. Today, remuneration is understood to include almost anything of value, whether direct or indirect, in cash or in kind.

Forms of remuneration that have drawn federal scrutiny include, among many others:

• Cash payments, bonuses, or “commissions” tied to referral volume.
• Salaries or directorship fees that exceed fair market value, or that pay for little real work.
• Free or below-market rent, office space, equipment, or staffing.
• Discounts, rebates, or waived fees not structured to fit an exception.
• Lavish meals, travel, entertainment, or gifts directed to referral sources.
• Equity interests, profit distributions, or investment opportunities offered to referral sources.
• Waiver of patient copayments or deductibles outside permitted circumstances.

The breadth of “remuneration” is precisely why ordinary business conduct can be recast as a kickback. A defense often focuses on whether the thing of value was actually tied to referrals, whether it reflected fair market value, and whether the government can prove the required link between the payment and an intent to induce.

Safe Harbors and the Statutory Exceptions

Recognizing that many legitimate arrangements involve payments between health care players, Congress and the Department of Health and Human Services created statutory exceptions and regulatory “safe harbors.” An arrangement that fits squarely within a safe harbor is protected from Anti-Kickback Statute liability. Safe harbors exist for, among other things, bona fide employment relationships, personal services and management contracts, space and equipment rentals, certain investment interests, and specified discount arrangements.

The crucial point — and a frequent source of trouble — is that safe harbors are voluntary and exacting. Each one has detailed conditions, and an arrangement must satisfy every condition to be protected. Failing a safe harbor does not automatically make an arrangement illegal; it simply means the arrangement is evaluated on its facts and intent. But a near-miss provides no guaranteed shelter, and prosecutors often point to a failed safe harbor as evidence that participants knew the rules and chose not to follow them.

Applied Insight: In our experience, disputes over safe harbors are rarely about whether one existed — they are about whether every technical condition was met. A defense frequently turns on showing that even if an arrangement fell outside a safe harbor, it was still structured in good faith, at fair market value, and without the willful, referral-driven intent the criminal statute requires.

Penalties for an Anti-Kickback Statute Conviction

A criminal conviction under the Anti-Kickback Statute is a felony. Each violation now carries a statutory maximum of up to 10 years in federal prison and a fine of up to $100,000 — penalties increased by Congress from the prior five-year, $25,000 ceiling. Because indictments typically charge multiple counts spanning many transactions, total exposure can be severe.

The collateral consequences are often just as serious as the prison exposure. They commonly include:

• Program exclusion. A conviction triggers mandatory exclusion from Medicare, Medicaid, and all federal health care programs — frequently fatal to a medical practice or health care business.
• Civil monetary penalties. The government may pursue separate civil penalties for kickback conduct, often in parallel with or instead of criminal charges.
• False Claims Act liability. Claims tainted by a kickback can be treated as false claims, exposing defendants to treble damages and per-claim penalties.
• Licensing and professional discipline. State medical, pharmacy, and other licensing boards routinely act on AKS convictions.
• Forfeiture and restitution. Courts can order forfeiture of proceeds and restitution to the affected programs.

In federal court, the advisory United States Sentencing Guidelines also drive the actual sentence — a subject our federal sentencing practice addresses in depth. For kickback offenses, loss amount, the defendant’s role, abuse of a position of trust, and related factors heavily influence the guideline range. Disputing the government’s loss calculation is often one of the most consequential parts of a sentencing defense.

How AKS Cases Connect to the False Claims Act

Anti-Kickback Statute exposure rarely travels alone. By statute, a claim for payment that results from a kickback is treated as a false or fraudulent claim under the False Claims Act. That linkage means a single arrangement can generate criminal charges, government civil litigation, and a whistleblower (qui tam) lawsuit at the same time.

Many AKS investigations in fact begin with a whistleblower — a former employee, competitor, or business partner who files a sealed qui tam complaint. The government investigates under seal, and the target may not learn of the case for months or years. By the time charges or a civil demand surface, prosecutors and agents have often already gathered documents, interviewed witnesses, and built a theory. Recognizing the civil and criminal threads early lets a defense respond coherently across all of them rather than reacting piecemeal.

On the civil side, one question has become a genuine battleground: how tight the link between a kickback and a claim must be before the claim is “false.” The 2010 amendment says a claim “resulting from” an Anti-Kickback violation is false, and the circuits now disagree about what “resulting from” means. The First and Sixth Circuits read it to require but-for causation — the government or relator must show the claim would not have been submitted absent the kickback. United States v. Regeneron Pharmaceuticals, Inc., 128 F.4th 324 (1st Cir. 2025); United States ex rel. Martin v. Hathaway, 63 F.4th 1043 (6th Cir. 2023). The Third Circuit applies a looser standard, requiring only a sufficient causal connection between the kickback and the claim. United States ex rel. Greenfield v. Medco Health Solutions, Inc., 880 F.3d 89 (3d Cir. 2018). Which rule governs can decide a civil case, and in a but-for jurisdiction it is one of the strongest tools a defense has for narrowing or defeating False Claims Act exposure built on an alleged kickback.

EKRA: The All-Payor Kickback Law (and Its 2025 Expansion)

A second kickback statute now shadows many of the same arrangements. EKRA — the Eliminating Kickbacks in Recovery Act, enacted in 2018 and codified at 18 U.S.C. § 220 — criminalizes remuneration paid to induce referrals to recovery homes, clinical treatment facilities, and clinical laboratories. Its defining feature is scope: where the Anti-Kickback Statute requires a federal health care program, EKRA reaches services covered by any health care benefit program, private insurance included. Each violation carries up to 10 years in prison and a $200,000 fine.

EKRA enforcement matured in 2025. In United States v. Schena, 142 F.4th 1217 (9th Cir. 2025), the Ninth Circuit affirmed EKRA convictions built on a lab’s marketing arrangements and resolved two questions that had divided district courts. First, the statute reaches payments to marketing intermediaries who deal with referring physicians — the marketer does not have to interact with patients at all. Second, a percentage-based compensation structure for marketers, standing alone, does not violate the statute; the line is crossed when remuneration is paid to influence referrals wrongfully, such as by directing marketers to make false or misleading claims about the services. That framework gives prosecutors a road map, and marketing-heavy laboratory and treatment-facility models are squarely in it.

EKRA also sets a trap for the compliance-minded: its statutory exceptions are narrower than the AKS safe harbors and do not mirror them. An employee compensation plan that satisfies the AKS bona fide employment safe harbor can still fall outside EKRA’s exception if the pay varies with the number of tests or procedures performed. When we evaluate a client’s marketing or compensation arrangement, we analyze it under both statutes separately — because the government certainly will.

Defenses to Anti-Kickback Statute Charges

No two kickback cases are the same, and no lawyer can promise an outcome. But several defense themes recur in Anti-Kickback Statute matters, and identifying which apply to a particular set of facts is central to building a strategy.

• Absence of willfulness. The statute demands willful, wrongful intent. Evidence that a defendant relied on counsel, followed compliance advice, or genuinely believed an arrangement was lawful can defeat the intent element.
• No inducement purpose. Where a payment reflects fair market value for genuine services or property and was not made to induce referrals, the government’s “one purpose” theory can be challenged on the facts.
• Fair market value and commercial reasonableness. Independent valuation evidence can show an arrangement was a real, arm’s-length business deal rather than a disguised kickback.
• Safe harbor or exception compliance. Demonstrating that an arrangement met a safe harbor — or substantially conformed to one — undercuts the inference of wrongful intent.
• Advice of counsel. Good-faith reliance on the advice of a qualified attorney, fully informed of the facts, can negate willfulness.
• Insufficient proof of a federal program nexus. The government must tie the conduct to items or services reimbursable by a federal health care program.
• Statute of limitations and procedural defenses. Timing, charging defects, and constitutional issues can narrow or end a case.

The right combination depends entirely on the evidence. Our role is to test the government’s proof element by element, develop the favorable record, and press every legitimate defense — at the investigation stage, in pretrial motions, at trial, and, where necessary, on appeal.

Applied Insight: The most valuable defense work in a kickback case often happens before an indictment exists. A well-prepared written submission to prosecutors — explaining the business rationale, the valuation support, and the absence of willful intent — can sometimes resolve a matter civilly, or end it, before it ever becomes a criminal case.

How Federal Anti-Kickback Investigations Begin

Anti-Kickback investigations surface in several recognizable ways. A subpoena from the Department of Health and Human Services Office of Inspector General or a grand jury, a Civil Investigative Demand, an unsealed qui tam complaint, an unannounced agent interview of an employee, or a request for records from a Medicare contractor can all be the first visible sign. Each signals that the government is already gathering evidence.

What you do in the days after that first contact matters. Preserving documents, avoiding casual statements to investigators, routing communications through counsel, and understanding whether you are a witness, a subject, or a target all shape the trajectory of the case. The Anti-Kickback Statute’s intent requirement means that early, careless explanations can become some of the government’s most damaging evidence. Measured, informed decisions early on protect your options later.

Why Work With Elizabeth Franklin-Best, P.C.

Anti-Kickback Statute cases are document-intensive, intent-driven, and frequently span parallel criminal and civil proceedings. They reward defense lawyers who read the statute and the case law closely and who build the record carefully. That is the practice we bring to every matter.

Elizabeth Franklin-Best, our principal attorney, is admitted to the United States Supreme Court and all twelve federal circuit courts of appeals, and she wrote Reversing Your Criminal Conviction, a practitioner text on post-conviction litigation. Our team — including Christopher Zoukis, our Managing Director, who focuses on federal sentencing and corrections issues — handles federal matters nationwide alongside those standing bar admissions. Across her career, Elizabeth Franklin-Best has handled more than 330 federal proceedings, over 100 of them appeals, and has appeared pro hac vice in district courts from Montana to Florida — the kind of cross-circuit appellate exposure that keeps emerging defenses on the table in a fast-moving enforcement area. We defend health care professionals, executives, and companies at every stage, from the first subpoena through trial and appeal, as part of our wider federal fraud defense practice.

Guaranteeing a result would be dishonest, so we never do it. What you can count on instead is practitioner-grade work: the statute read closely, the evidence assessed without wishful thinking, and a defense fitted to your facts rather than to a template. If an Anti-Kickback Statute investigation or charge has reached you, scheduling a paid, one-hour initial consultation is the place to begin.

Talk With an Anti-Kickback Statute Defense Lawyer

A kickback investigation threatens three things at once: your liberty, your professional license, and the business you spent a career building. Those threats grow as the government’s file grows, which is why timing matters more in these cases than almost any other factor. To put your arrangement in front of our team confidentially, schedule your paid, one-hour initial consultation.

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