The Anti-Kickback Statute and the False Claims Act in the Eleventh Circuit: Elements, Standards, and the Open Causation Question

When the government or a relator brings an Anti-Kickback or False Claims Act case in Florida, Georgia, or Alabama, it has to satisfy a specific set of elements the Eleventh Circuit has spelled out case by case, sitting under a few Supreme Court holdings that control everywhere. Counsel who knows those elements can see early where a case is strong for the government and where it is exposed. This article lays out the framework the Eleventh Circuit actually applies to the Anti-Kickback Statute and to the False Claims Act theories built on it, then isolates the one causation question the Circuit has still not answered.

A word on authority levels, because they decide how much weight each case carries. A United States Supreme Court holding controls everywhere. An Eleventh Circuit decision controls in the Eleventh Circuit and is only persuasive elsewhere. A decision from another circuit is persuasive here, never binding. The map below keeps those levels marked, because a rule that binds a court in Boston may be worth little to a court in Miami.

The Anti-Kickback elements the Eleventh Circuit applies

The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), criminalizes paying or receiving remuneration to induce referrals of items or services covered by a federal health care program. The Eleventh Circuit has reduced the paying-side offense to four elements a jury must find. In United States v. Vernon, 723 F.3d 1234 (11th Cir. 2013), the court held that to convict, the government had to prove the defendant "(1) knowingly and willfully, (2) paid money, directly or indirectly, ... (3) to induce [the recipient] to refer individuals ... for the furnishing of [the item or service], (4) paid for by Medicaid." Vernon, 723 F.3d at 1252-53. Those four elements are what the government must establish and what the defense tests.

The inducement element carries a rule that catches many defendants by surprise. A payment violates the statute even if securing referrals was not its only purpose. Affirming the jury instruction in Vernon, the Eleventh Circuit approved a charge allowing conviction where the remuneration "was offered, paid, solicited, or received at least in part to induce or in exchange for the referral" of a federally insured patient. Vernon, 723 F.3d at 1262-63. This is the "one purpose" principle. A payment that has a legitimate business rationale still violates the statute if inducing referrals was one of its purposes. A defense built on the deal's ordinary commercial features has to reckon with that standard head-on.

That focus on the decisionmaker also explains why the statute reaches non-physicians. In Vernon the court rejected the argument that only a physician can "refer" a patient, holding that the statute reaches anyone who is the relevant decisionmaker over where a patient's business goes. Vernon, 723 F.3d at 1253-56. That reading matters for marketing arrangements, patient-navigator roles, and any structure that routes federally reimbursed patients through a paid intermediary.

Willfulness: what the government must prove, and what it need not

The mental state is where Anti-Kickback cases are often won or lost, and the Eleventh Circuit's standard is more favorable to the government than defendants expect. In United States v. Starks, 157 F.3d 833 (11th Cir. 1998), the court adopted the Supreme Court's formulation from Bryan v. United States, 524 U.S. 184 (1998), and held that "knowledge that conduct is unlawful is all that is required." Starks, 157 F.3d at 838. The government does not have to prove the defendant knew of the Anti-Kickback Statute specifically or understood that a particular arrangement violated it. It has to prove the defendant knew the conduct was unlawful in a general sense.

Starks explained why the Anti-Kickback Statute does not get the more forgiving mens rea reserved for technical regulatory crimes. The statute "is not a highly technical tax or financial regulation that poses a danger of ensnaring persons engaged in apparently innocent conduct," because "the giving or taking of kickbacks for medical referrals is hardly the sort of activity a person might expect to be legal." Starks, 157 F.3d at 838. The court placed medical kickbacks in the category of conduct that is wrong in itself, not merely wrong because a rule prohibits it. A good-faith defense therefore has to attack knowledge of unlawfulness, not knowledge of the statute.

The standard has held. In United States v. Grow, 977 F.3d 1310 (11th Cir. 2020), the court affirmed kickback convictions on evidence that the defendant "knew it was illegal to pay and receive illegal kickbacks," pointing to his having read the statute, signed compliance agreements, and told his own representatives the conduct was unlawful. Grow, 977 F.3d at 1328-29. Grow is a recent, concrete illustration of the proof the government marshals to meet the willfulness element, and a useful checklist of the documents a defendant's own files may supply against him.

Common Anti-Kickback prosecution schemes

The elements above stay abstract until you see how the government actually charges an Anti-Kickback case. Most modern prosecutions share a shape. A party who controls or generates federally reimbursable business is paid for steering it, and the payment is dressed up as marketing, a consulting arrangement, a speaking fee, or a commission. The labels vary; the theory does not.

A handful of scheme types recur.

• Compounding-pharmacy and prescription schemes. Marketers are paid a cut of the reimbursement on each prescription they steer to a pharmacy, often for high-margin compounds of dubious medical value billed to Medicare or TRICARE. The Eleventh Circuit affirmed kickback and health-care-fraud convictions on exactly this structure in United States v. Grow, 977 F.3d 1310 (11th Cir. 2020), where the marketer took his cut of paid claims and paid recruiters below him. Grow, 977 F.3d at 1327-29.
• Telemedicine paired with durable medical equipment or genetic testing. Call centers and "patient recruiters" solicit beneficiaries, telemedicine practitioners are paid to sign orders they never meaningfully evaluate, and suppliers or labs pay for the signed orders. OIG singled out this model in its 2022 telemedicine Special Fraud Alert, warning of arrangements where a practitioner is compensated "based on the volume of items or services ordered."
• Clinical and toxicology laboratory marketing. Labs pay independent-contractor sales reps a percentage of the revenue the lab collects on the testing those reps arrange. That percentage-of-lab-revenue structure paid to non-employee marketers is a paradigm kickback theory, and in the laboratory setting it also implicates EKRA (below).
• Pharmaceutical speaker programs and sham consulting. Honoraria, "advisory" fees, and speaking payments function as rewards for prescribing rather than payment for real services. OIG's 2020 Special Fraud Alert on speaker programs flagged compensation that "takes into account the volume or value of past business generated."
• Patient recruiting and brokering. Paying non-clinicians a per-head fee to deliver patients is one of the oldest forms of the offense. The Eleventh Circuit affirmed convictions of this kind in United States v. Starks, 157 F.3d 833 (11th Cir. 1998), where a treatment-center operator paid community aides a flat sum for each patient referred. Starks, 157 F.3d at 836.

Does paying a marketer constitute a kickback?

This is the question defense counsel hears most, and the honest answer is that it depends on what the marketer does and how the marketer is paid. Paying for legitimate advertising is lawful. Paying someone to deliver or steer federally reimbursable business is not, and the line runs through two ideas the courts have made concrete.

The first is the "one purpose" rule. A payment violates the statute if inducing referrals was one of its purposes, even where it also compensated for real work. The Third Circuit set the rule down in United States v. Greber, 760 F.2d 68 (3d Cir. 1985), holding that "if one purpose of the payment was to induce future referrals, the medicare statute has been violated." Greber, 760 F.2d at 69. The payment there was a percentage-of-reimbursement "interpretation fee" to referring physicians, and it did not matter that the physicians performed some service for it. Greber, 760 F.2d at 71-72. The Eleventh Circuit applies the same standard, approving a charge that reached remuneration paid "at least in part to induce or in exchange for the referral" of a federally insured patient. United States v. Vernon, 723 F.3d 1234, 1262-63 (11th Cir. 2013). A marketing label on the check does not defeat the theory if one purpose of the payment was to move patients.

The second idea sorts lawful marketing from an illegal kickback, and it turns on whether the marketer is the person who actually controls where the business goes. Two decisions frame the contrast. In United States v. Polin, 194 F.3d 863 (7th Cir. 1999), a monitoring service paid a pacemaker sales representative fifty dollars for each Medicare patient he steered its way. Because the representative directed which service got the patient, with the physician's sign-off amounting to a "rubber stamping," the Seventh Circuit called it "a classic case of an illegal kickback" and rejected the argument that only a physician can "refer." Polin, 194 F.3d at 866-67. In United States v. Miles, 360 F.3d 472 (5th Cir. 2004), by contrast, a company paid a public-relations firm to advertise its services to physicians who then independently chose the provider. The Fifth Circuit reversed the kickback convictions because "the payments... were not made to the relevant decisionmaker as an inducement or kickback for sending patients," while acknowledging that in other situations "payments to non-doctors would fall within the scope of the statute." Miles, 360 F.3d at 480. The Eleventh Circuit lands with Polin. In Vernon it treated a commission paid to the third party who controlled the referrals as a kickback. Vernon, 723 F.3d at 1253-56.

Put together, the two ideas answer the question. Paying a marketer to advertise to independent decision-makers is defensible. Paying a marketer who himself directs or generates the reimbursable business, especially on a per-referral or percentage basis, is the paradigm kickback. Grow is the illustration, where the marketer was paid a percentage of the reimbursement on the prescriptions he steered. Grow, 977 F.3d at 1327-29. And because the government need only prove the defendant knew the conduct was unlawful, not that he knew the Anti-Kickback Statute, a marketer's own compliance files, contracts, and emails often supply the willfulness proof. Starks, 157 F.3d at 838; Grow, 977 F.3d at 1328-29.

Common safe harbors

Congress and the Department of Health and Human Services built a set of exceptions and "safe harbors" precisely because many ordinary business arrangements involve payments that could otherwise be read as inducements. Two points frame all of them. An arrangement that fits a safe harbor is protected. An arrangement that misses one is not automatically illegal; it is judged on its facts and on intent.

The safe harbors most relevant to marketing and compensation arrangements are these.

• The employee exception. Payments by an employer to a bona fide employee for the furnishing of covered items or services are excepted from the statute. 42 U.S.C. § 1320a-7b(b)(3)(B); 42 C.F.R. § 1001.952(i). This is why a genuine W-2 sales employee can be paid commissions on reimbursable business and remain protected, while the same commission paid to an independent contractor is not.
• Personal services and management contracts. Payments to an agent for services can be protected where the agreement is written and signed, runs at least a year, specifies the services, and, critically, sets the compensation methodology in advance at fair market value in a way that does "not take into account the volume or value of any referrals." 42 C.F.R. § 1001.952(d). The 2020 "Regulatory Sprint" rulemaking relaxed the old requirement that the aggregate compensation be fixed in advance, replacing it with a set-in-advance methodology, but it kept the bar on volume-or-value-based pay.
• Space and equipment rental ((b), (c)) and discounts ((h)) round out the arrangements marketers and providers most often invoke, each on parallel conditions of written terms, fair market value set in advance, and no tie to referral volume.

The gap in that list is the point. No safe harbor protects percentage-of-revenue or per-referral compensation paid to an independent-contractor marketer. OIG has said as much directly, concluding that a percentage arrangement falls outside the personal-services harbor and is "at least a potential technical violation" of the statute. A percentage deal fails the personal-services harbor on the volume-or-value prong, and the employee harbor is unavailable because the marketer is not an employee. That is why the structure recurs in the prosecutions above.

One further statute reshapes this analysis for laboratories, recovery homes, and clinical treatment facilities. The Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220, enacted in 2018, reaches referrals paid for by any payer, federal or commercial, and its exception for employee and contractor pay is narrower than the Anti-Kickback Statute's. It bars compensation that varies with the volume of referrals or tests even for a bona fide employee, so a commission structure that survives the Anti-Kickback employee safe harbor can still violate EKRA.

For any specific arrangement, the practical questions track the doctrine. Is the marketer a bona fide employee, or an independent contractor? Is the pay a fixed, fair-market-value fee for defined services, or a share of the reimbursement? Does the marketer influence or generate the reimbursable business? And in the laboratory or recovery setting, does EKRA impose the stricter, all-payer standard? Counsel evaluating a marketing arrangement, or defending one, starts there.

When an Anti-Kickback violation makes a claim "false": the open causation question

A separate statute converts an Anti-Kickback violation into False Claims Act exposure. Since 2010, a claim that "results from" a kickback is a false claim for False Claims Act purposes. 42 U.S.C. § 1320a-7b(g). What "results from" requires is the live, unsettled question, and it is where jurisdiction matters most.

The Supreme Court has held, in a different statutory setting, that "results from" ordinarily imports actual, but-for causation. Burrage v. United States, 571 U.S. 204 (2014). Whether that reading governs the Anti-Kickback link is the point on which the circuits have divided.

The discipline here is to resist flattening this into a two-sided split. Three things are happening at once. The First, Sixth, and Eighth Circuits require but-for causation. The Third Circuit accepts a lesser "some connection" showing. The Fourth and Seventh Circuits have looked at the question and declined to resolve it, which is not a vote for either side. A reserved question is an open question in that circuit.

For the Eleventh Circuit the practical point is direct. The court has not decided the standard, and no clear district-court trend has settled it. An older Eleventh Circuit decision predates the 2010 amendment and does not construe § 1320a-7b(g), so it does not fill the gap. Counsel should treat the governing causation standard in this Circuit as unresolved and brief it as a question of first impression rather than assume an answer in either direction.

Falsity is a separate element, and here the Eleventh Circuit gives defendants a rule

Causation and falsity are not the same inquiry, and they get argued as one at the defense's peril. On the civil side, where the dispute is about a reasonable clinical or medical-necessity judgment, the Eleventh Circuit requires objective falsity. In United States v. AseraCare, Inc., 938 F.3d 1278 (11th Cir. 2019), the court held that a clinical judgment of terminal illness "cannot be deemed false, for purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of that conclusion, with no other evidence to prove the falsity of the assessment." AseraCare, 938 F.3d at 1281. A mere battle of experts does not establish falsity; the government must point to something more, facts inconsistent with the exercise of the clinical judgment claimed.

AseraCare is controlling authority a defendant in this Circuit can use and a defendant elsewhere may lack. It should not be assumed to travel outside the Eleventh Circuit, and it is addressed to reasonable clinical judgment, not to coding or factual-accuracy disputes, which run on a different track. Like the causation standard, the strength of a falsity defense turns on the forum.

Scienter: settled as subjective

The knowledge element under the False Claims Act is settled at the framework level. In United States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739 (2023), the Supreme Court held that scienter turns on the defendant's own "knowledge and subjective beliefs," not on what an objectively reasonable person might have believed. Schutte, 598 U.S. at 740-41. A defendant who actually believed a claim was false does not escape liability because the governing language could, after the fact, bear an innocent reading. Schutte resolved scienter, not falsity, and the two remain distinct elements that should be argued separately.

Materiality: demanding, with a government-knowledge defense

Materiality is the element that most often defeats an implied-certification theory. In Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016), the Supreme Court held that "[t]he materiality standard is demanding." Escobar, 579 U.S. at 194. A requirement is not material merely because the government labeled compliance a condition of payment. And where the government "pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material." Escobar, 579 U.S. at 195. The government-knowledge defense flows directly from that language. It is fact-specific, and it fails where the government lacked actual knowledge or where the requirement really was central to the payment decision.

What this means for an Eleventh Circuit defendant

The framework above turns into a short list of questions counsel should ask when evaluating exposure in this Circuit.

• Do the facts meet each of the four Vernon elements?
• What did the defendant actually know about the lawfulness of the arrangement, the willfulness question under Starks and Grow?
• Was inducing referrals one purpose of the payment, even alongside a legitimate business rationale?
• Does the falsity theory rest on a reasonable clinical judgment that AseraCare protects?
• Was the alleged violation material to payment under Escobar, and did the government keep paying with knowledge of it?
• Which causation standard will the forum apply to the "resulting from" question the Eleventh Circuit has left open?

The firm's Federal Health Care Fraud Defense Report 2026 develops these questions in its core-defense and special-topics sections, and our companion article on how a False Claims Act case works covers the procedural bars that often end these cases before the merits. If you are analyzing an Anti-Kickback or False Claims Act matter, we are available to discuss the specifics.

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Daniel FridmanManaging PartnerView profile →