Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision
The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years after the complaint was filed, a Special Master recommended granting United’s motion for summary judgment. U.S. ex rel. Poehling v. UnitedHealth Group, Inc., 2025 U.S. Dist. LEXIS 40921 (CD CA). Both the litigation and the Special Master’s report contain valuable insights for all FCA defendants, and especially for those matters involving allegations related to diagnosis coding.
The government alleged that United violated the FCA’s “reverse false claim” provision by failing to return overpayments related to the submission of allegedly invalid diagnosis codes in connection with the MA program. The Special Master recommended summary judgment in United’s favor due to the government’s inability to prove both that United was actually overpaid, and that it improperly avoided an obligation to repay the government. In doing so, the ruling highlights the government’s burden to prove that 1) a diagnosis code is false; and 2) that a defendant “deceived” the government in “improperly” withholding an overpayment. It also confirms that materiality is an essential element of a “reverse” FCA violation.
Lesson #1: The Government Must Prove Its Case
The Special Master found that the government did not prove the diagnosis codes were unsupported by medical records because the government did not actually review the medical records. Instead, the government identified nearly 28 million diagnosis codes that it argued were invalid, but “did not compare the diagnosis codes submitted by United’s doctors against the underlying medical records to identify unsupported diagnosis codes.” Rather, “if United’s coders did not identify a diagnosis code during chart review as supported by a medical record, the government assume[d] the diagnosis code was, in fact, not supported.” (Emphasis in original). The Special Master found that assumption woefully insufficient.
The Special Master also found it compelling that CMS’s own RADV audits “found support in medical records for diagnosis codes that the government has alleged were unsupported based solely on such codes not having been coded during United’s chart review. These findings undercut the government’s theory that any diagnosis code submitted by United to CMS but not identified by coders in chart review is presumptively invalid.”
The Special Master further pointed out that “the government has repeatedly attempted to shift the burden to United to disprove the government’s allegations. Rather than review medical records itself, the government served discovery asking United to identify which of the approximately 28 million diagnosis codes, if any, United contends were supported by medical records and to produce the medical records providing such support.” (Emphases in original). United properly objected to this as “‘an improper contention interrogatory that impermissibly seeks to shift the burden of proving an essential element of the government’s False Claims Act case on to UnitedHealth . . .’” but offered to produce the 21 million underlying medical records in order to resolve the discovery dispute. The government rejected that offer, apparently, due to the volume of documents. The Special Master wryly noted that “the government was responsible for placing that volume of records in dispute.” Defendants should push back on government attempts to force them to prove their innocence, and to take on the government’s own investigatory and evidentiary obligations.
Lesson #2: The FCA Is A Fraud Statute
At base, the False Claims Act is a “fraud statute.” See e.g., United States ex rel. Schutte v. SuperValu, Inc., 598 U.S. 739, 750-51 (2023). As such, the Special Master appropriately focused on the government’s position that “mere avoidance of an obligation to repay money to the government is enough to create liability under the FCA, without the need to prove any deceptive conduct” and found that this position obviates the nature of a fraud statute. The Special Master ruled that “the impropriety of a defendant’s retention of an overpayment cannot be grounded in the mere fact of the defendant having received the overpayment, or even of being obligated to return it. Otherwise, the requirement of ‘improper’ conduct would introduce circularity and surplusage into a statute where Congress clearly intended nothing of the kind.” Quite simply, “a reverse FCA claim requires proof that the defendant engaged in conduct that deceived the government about an obligation to repay funds.”
Here, the government did not allege “any sort of deception.” Even if United had retained an overpayment, “[t]he mere retention of overpayments may deprive the government of funds it is owed, but that is not fraud.” While the failure to allege deception was fatal by itself, here there was also evidence that “the government knew of the very chart review practices of which it now claims United prevented it from learning, and thus the government cannot have been duped into relying on any action or inaction by United in determining whether it had been the victim of overpayments.”
The bar for both pleading and proving fraud is high. Fed. R. Civ. Pro. 9(b). Here, the Special Master correctly recognized that “[i]n relying upon only the ‘knowing and improper avoidance’ formulation of reverse FCA liability, the government must establish that United knew it had received overpayments and acted in a way that kept the government from learning of the overpayment.” Defendants should hold the government to those requirements. Quite simply, fraud and breach of contract are radically different, and proving fraud is, and should be, hard.
Lesson #3: Materiality Matters
In the eight years since the publication of Universal Health Services v. United States ex rel. Escobar, 579 U.S. 176 (2016), this blog has written extensively about materiality. More than 1,100 court decisions cite to Escobar. Escobar’s impact is significant and pervasive. Here, the government argued that “materiality is not a required element of establishing liability under the second prong of the reverse false claim provision.” The Special Master disagreed:
Escobar and subsequent Ninth Circuit cases recognize that, like the FCA as a whole, its reverse false claims provision incorporates the elements of common law fraud (although the provision expands the notion of what constitutes a “false claim” under the statute). Accordingly, a materiality element must apply to that provision, regardless of which of its two prongs is the basis for the government’s claim in a given case, because of the inconceivability of fraud absent a materiality element.
(Emphasis added, citations omitted). FCA defendants should continue to hold the government to its burden to prove materiality as well.
Conclusion
While the threat of treble damages, per claim penalties, and a variety of administrative remedies (including, but not limited to, suspension and debarment) are intimidating, FCA defendants should take comfort in this decision, which underscores the value of investing in a good defense and litigation strategy. Courts will hold the government’s feet to the fire and require it to meet its burden to prove fraud which, as here, it often simply cannot do.
Listen to this post
Another CTA Freeze: Treasury Department Announces Suspension of Enforcement Against Domestic Reporting Companies
If you have been following our reports on the subject, you know that the Corporate Transparency Act (CTA) had a tumultuous end to 2024 and start to 2025, with a series of court actions leading to oscillating reports about whether the CTA was enforceable. Now, the elements of the executive branch of government that were pushing courts to allow for enforcement of the CTA have announced a self-initiated freeze on enforcement until the CTA reporting regime can be reformed through their further rulemaking.
FinCEN’s February 27 Release
On February 27, 2025, the Financial Crimes Enforcement Network (FinCEN), a bureau of the US Department of Treasury (Treasury), announced: “that it would not issue any fines or penalties or take any other enforcement actions against any companies based on any failure to file or update beneficial ownership information (BOI) reports pursuant to the Corporate Transparency Act by the current deadlines…until a forthcoming interim final rule becomes effective and the new relevant due dates in the interim final rule have passed.”
FinCEN also stated that it intends to issue an interim final rule no later than March 21, 2025, that extends BOI reporting deadlines and recognized “the need to provide new guidance and clarity as quickly as possible, while ensuring that BOI that is highly useful to important national security, intelligence, and law enforcement activities is reported.”
Treasury’s March 2 Release
Then, on March 2, 2025, Treasury went a step further than FinCEN, stating that it will not enforce any penalties or fines against US citizens or domestic reporting companies or their beneficial owners after the forthcoming FinCEN interim rule takes effect.
Treasury also stated that it will issue a proposed rule that will narrow the scope of the CTA to foreign reporting companies only. The CTA defines a foreign reporting company as a corporation, limited liability company or other entity formed under the law of a foreign country and registered to do business in any state or tribal jurisdiction by filing of a document.
As of the time of this release neither FinCEN’s interim final rule nor Treasury’s proposed rule had been made publicly available.
State Corporate Transparency Laws
As a reminder, certain states have adopted regimes modeled on, and in some cases referencing, the provisions of the CTA. For example, the New York LLC Transparency Act will start requiring beneficial ownership reporting as of January 1, 2026, for limited liability companies organized or registered to do business in New York. It will be interesting to see what, if any, changes are made by New York and other states based on future CTA rulemaking.
The Bracewell CTA Task Force will continue to monitor and report on developments regarding the CTA.
FinCEN Suspends Enforcement of CTA Against U.S. Citizens and Domestic Reporting Companies
Article highlights:• Treasury Dept. will no longer enforce CTA reporting requirements against U.S. citizens and domestic companies• Future rule changes expected to limit reporting requirements to foreign entities• March 21, 2025, filing deadline no longer relevant for U.S. businesses
The Corporate Transparency Act (CTA) has taken yet another dramatic turn. As previously reported, the final nationwide injunction against enforcement of the CTA was lifted on February 17th. Days later, FinCEN announced another 30-day extension of the filing due date, making the new deadline March 21, 2025. However, on March 2, 2025, the Treasury Department announced it would suspend enforcement of the CTA’s beneficial ownership information (BOI) reporting requirements for U.S. citizens and domestic reporting companies, even if those companies failed to meet the previously extended March 21st filing deadline. The agency said that it intends to issue new rulemaking proposals to focus the CTA’s enforcement solely on “foreign reporting companies.” It remains to be seen whether enforcement would include foreign individuals/entities holding ownership interests in domestic reporting companies — as presumably intended by the original law.
What does this mean?Because FinCEN will not enforce the CTA reporting rules against domestic businesses, the March 21 deadline for BOI filings is effectively no longer relevant for most entities. The Treasury Department has not yet provided a timeline for issuing its proposed rule changes. However, even though the Treasury has decided not to enforce the CTA right now, the underlying statute remains in effect — meaning Congress will still need to take some action to repeal or modify the existing law. How and when that might happen remains to be seen.
We will continue to monitor and provide updates as new information becomes available. In the meantime, for those who still have questions about their reporting obligations, stay up to date by monitoring the Chuhak Newsroom regularly or contact a member of our CTA team for the latest guidance.
Corporate Transparency Act Enforcement Suspended Once Again!
On March 2, 2025, the U.S. Treasury Department announced it would not enforce any penalties or fines associated with the Beneficial Ownership Information (“BOI”) reporting rule, a key requirement under the Corporate Transparency Act (“CTA”).
In a press release, Treasury officials confirmed they would not impose fines on U.S. citizens or domestic reporting companies, effectively pausing the reporting obligations for the time being.
Relief for Domestic Businesses
Under the original CTA guidelines, most companies with fewer than 20 full-time employees and less than $5 million in annual revenue—as well as community associations—would have been required to file their BOI reports with the Financial Crimes Enforcement Network (FinCEN).
After weeks of legal back-and-forth, with temporary injunctions followed by stays of those injunctions, a U.S. District Court ultimately stayed the nationwide injunction, extending the compliance deadline to March 21, 2025. Now, with the Treasury’s latest move, domestic businesses are temporarily off the hook from meeting the CTA’s reporting requirements, offering much-needed breathing room for companies struggling with compliance.
A Shift in Focus: Foreign Companies Under Scrutiny
Perhaps the biggest takeaway from the Treasury’s announcement is a shift in enforcement priorities. Moving forward, the agency plans to limit BOI reporting obligations to foreign reporting companies, signaling a departure from the previous broad enforcement approach. Treasury officials said they intend to issue new regulations to formally adjust the CTA’s scope, concentrating efforts on international entities rather than U.S.-based businesses.
While the full implications of this change remain to be seen, the decision is expected to ease compliance concerns for American companies. Meanwhile, foreign businesses should prepare for heightened scrutiny as the Treasury reshapes its corporate transparency policies.
For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron Pharmaceuticals Inc. on False Claims Act Litigation
The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). At issue in Wisconsin Bell was whether reimbursement requests submitted to the FCC’s “E-Rate Program” are considered “claims” under the FCA. The U.S. Supreme Court agreed that they were, finding that the plaintiff’s liability theory could move forward.
While the issues presented in Wisconsin Bell occurred in the context of the FCC, the implications of the Court’s decision appear to extend far beyond—reaching industries frequently targeted for FCA enforcement, such as health care, aerospace, defense, energy and others involving government contracts (like cybersecurity). As in years past, SCOTUS’s docket and Wisconsin Bell reflects the continued significance of FCA litigation and its importance to the government’s recovery of funds. Therefore, all companies that receive federal funds, particularly in highly regulated industries such as health care, should be interested in understanding this ruling and its impact.
Wisconsin Bell had argued that it could not be exposed to FCA liability because the E-rate program, congressionally mandated to help certain schools and libraries afford internet and telecommunications, is administered by a private nonprofit organization and funded by government-mandated payments from private telecommunications carriers into the Universal Service Fund (USF). But the Court ruled narrowly that, because the U.S. Treasury itself had provided $100 million to the USF, through its collection of delinquent debts to the USF and related penalties and interest, as well as other settlements and criminal restitution payments, the federal government did “provide” a portion of the funds at issue, so the whistleblower’s allegations are thus covered under the FCA.
One thing of interest is seen in the concurrence from Justice Kavanaugh (with Thomas concurring) who renewed their questions about the constitutionality of the FCA’s qui tam provisions (and thereby invited future challenges), writing in Wisconsin Bell that “the [False Claims] Act’s qui tam provisions raise substantial constitutional questions under Article II. … [I]n an appropriate case, the Court should consider the competing arguments on the Article II issue.” Ultimately though, it was a unanimous decision, where the Supreme Court found that that E-Rate reimbursement requests were “claims” under the FCA.
Another interesting aspect is that the Court’s decision was notably narrow, relying on the U.S. Treasury’s supply of a $100 million ancillary sliver of overall USF funding, which totals nearly $10 billion annually. Justice Thomas’s concurrence (with Justice Kavanaugh concurring, and Justice Alito concurring in part) highlights the limits of this approach, observing that, “the Government paid scant attention to the fact that courts historically have not applied the FCA to cover fraud on nongovernment entities unless the Government itself will face a financial loss.” And, the Court’s opinion itself forewarns that issues of, “whether (and, if so, how) the amount of money the Government deposited should limit the damages Heath can recover” are likely to emerge if Heath ultimately prevails.
The narrow holding was necessary because, as the Court explained, larger questions as to the constitutionality of the USF under the nondelegation doctrine are looming in a separate case, Consumers’ Research v FCC, Docket Nos. 24-354, 24-422 (set for oral argument on March 26, 2025). Notably, Justice Thomas’s concurrence sends a warning shot for the Government in that case, questioning the implications of its other two arguments – either that the entire USF constitutes government funds, or that the private, non-profit USF administrator is an agent of the United States – for those constitutional questions, and for compliance with a separate statute, the Government Corporation Control Act. Those answers are likely to affect Heath’s potential for eventual recovery. (The fact that Justice Kavanaugh – seen as a potential swing vote in Consumers’ Research – joined this concurrence may also be an ominous portent for the future of the USF as currently constituted. See our recent Client Alert for more details about the issues presented in the Consumers’ Research case.)
In another recent and important FCA decision, United States v. Regeneron Pharmaceuticals Inc., the First Circuit joined some other courts of appeal in holding that the “but-for” causation standard applies when purported Anti-Kickback Statute (AKS) violations result in FCA violations. This is a commonly used theory because it allows plaintiffs to allege that when a relationship becomes tainted by kickbacks then all reimbursement claims to a federal payor that follow are tainted and fraudulent, triggering FCA liability.
In Regeneron Pharmaceuticals Inc., the First Circuit had to evaluate competing arguments from the government and defendant about whether the 2010 amendments to the AKS effectively changed the proof requirements under this theory. As the court explained,
Regeneron argued that, under the 2010 amendment, the government “b[ore] the burden of proving that an AKS violation … actually caused [a] physician to provide different medical treatment (and thus caused the false claims).” United States v. Regeneron Pharms., Inc., No. 20-11217, 2023 WL 6296393, at *10 (D. Mass. Sept. 27, 2023). In other words, Regeneron asserted that the phrase “resulting from” in the 2010 amendment imposed a “ ‘but-for’ causation standard.” Id. The government disagreed, and it urged the district court to adopt the Third Circuit’s view that “all that is required to prove a causal link [under the 2010 amendment] is that ‘a particular patient is exposed to an illegal recommendation or referral and a provider submits a claim for reimbursement pertaining to that patient.’ ” Id. (quoting United States ex rel. Greenfield v. Medco Health Sols., Inc.,880 F.3d 89, 100 (3d Cir. 2018)).
After evaluating various textual arguments asserted by the government, the First Circuit found that was no good reason “to deviate from the default presumption that the phrase ‘resulting from’ as used in the 2010 amendment imposes a but-for causation standard” and that “to demonstrate falsity under the 2010 amendment, the government must show that an illicit kickback was the but-for cause of a submitted claim.”
Since there is a clear circuit court split on this issue, it is ripe for certiorari by the Supreme Court.
Since False Claims Act plaintiffs are motivated by the potential of obtaining significant bounties by suing companies and individuals that do business with government agencies and affiliates, these and other recent decisions underscore the continued importance for companies that receive federal funds to have robust compliance plans and take appropriate steps to avoid becoming embroiled in these bet-the-company cases.
Texas Federal Court Holds that Dodd-Frank Act Whistleblower Protection Law Does Not Authorize Jury Trials [Video]
On February 20, 2025, Judge Horan held in Edwards v. First Trust Portfolios LP that a Dodd-Frank whistleblower retaliation plaintiff is not entitled to a jury trial. This opinion underscores the importance of bringing additional claims that can be heard by a jury, including a Sarbanes-Oxley (SOX) whistleblower retaliation claim.
Aaron Edwards filed suit against his former employer, First Trust, alleging that he was terminated in retaliation for raising concerns about a gift program. Edwards claimed that First Trust’s practice of only awarding gifts to financial advisors at the end of the year who sold the most First Trust products during that year constituted an illegal sales contest under SEC regulations. He brought claims under the whistleblower protection provisions of SOX, the Dodd-Frank Act, and the Consumer Financial Protection Act (CFPA). After Judge Horan denied First Trust’s motion for summary judgment, First Trust moved to strike Edwards’ jury demand for his Dodd-Frank retaliation claim.
In contrast to an express provision in SOX clarifying that a SOX plaintiff “shall be entitled to trial by jury,” the whistleblower protection provision of the Dodd-Frank Act does not expressly provide for a right to a jury trial, so this dispute hinges on whether Dodd-Frank Act retaliation remedies are legal or equitable in nature (if the remedies are legal, then there is a right to a jury trial under the Seventh Amendment). Per the Supreme Court’s decision in SEC v. Jarkesy, the key factor determining “whether a monetary remedy is legal is if it is designed to punish or deter the wrongdoer, or, on the other hand, solely to restore the status quo.” 603 U.S. 109, 123 (2024).
A prevailing whistleblower in a Dodd-Frank whistleblower retaliation action is entitled to reinstatement, double back pay with interest, and litigation costs, including attorneys’ fees. Edwards argued that double back pay damages are legal in nature because they “go beyond restoring the status quo to deter and punish Dodd-Frank violators” and that Dodd-Frank’s doubling of back pay transmutes it from an equitable to legal remedy because it “serves to deter future misconduct by litigants.”
First Trust, however, asserted that under Fifth Circuit precedent, Dodd-Frank retaliation remedies, including reinstatement and back pay, are equitable in nature. Relying on a Georgia district judge decision, Judge Horan held that reinstatement and back pay are generally recognized as equitable remedies and that the automatic doubling of back pay does not change it from an equitable remedy to a legal one. See Pruett v. BlueLinx Holdings, Inc., No. 1:13-cv-02607-JOF, 2013 WL 6335887 (N.D. Ga. Nov. 12, 2013).
Since Edwards is already trying his SOX claim before a jury, and the motion to strike was filed close to trial, Judge Horan held that a binding jury will be empaneled for Edwards’s SOX claim and the same jury will serve as an advisory jury for Edwards’s Dodd-Frank claim.
Strategic Considerations: Why a Whistleblower Should Bring Both SOX and Dodd-Frank Whistleblower Retaliation Claims
Where a whistleblower that suffered retaliation qualifies for protection both under SOX and the Dodd-Frank Act, we recommend bringing both claims uto maximize the potential recovery. There are four advantages to bringing a SOX claim in addition to a Dodd-Frank claim:
Uncapped special damages: The Dodd-Frank Act authorizes economic damages and equitable relief but does not authorize non-economic damages. In contrast, SOX authorizes uncapped “special damages” for emotional distress and reputational harm.
Exemption from mandatory arbitration: SOX provides an unequivocal exemption from mandatory arbitration, but Dodd-Frank claims are subject to arbitration.
Preliminary reinstatement: If an OSHA investigation concludes that an employer violated the whistleblower protection provision of SOX, OSHA can order the employer to reinstate the whistleblower. However, there is some dispute as to whether an OSHA order of reinstatement is enforceable. See, e.g., Gulden v. Exxon Mobil Corp., 119 F.4th 299 (3d Cir. 2024).
Favorable causation standard: A far more generous burden of proof (“contributing factor” causation under SOX, rather than “but for” causation under Dodd-Frank).
There are four advantages to bringing a Dodd-Frank claim in addition to a SOX claim:
Double back pay: Dodd-Frank authorizes an award of double back pay (double lost wages) plus interest, whereas SOX authorizes ordinary back pay with interest along with other damages. Both statutes authorize reinstatement and attorney fees.
Longer statute of limitations: Whereas the statute of limitations for a SOX retaliation claim is just 180 days, the statute of limitations for a Dodd-Frank retaliation claim is a minimum of 3 years after the date when facts material to the right of action are known or reasonably should have been known by the whistleblower.
Broader scope of coverage: SOX whistleblower protection applies primarily to employees of public companies and contractors of public companies. The Dodd-Frank prohibition against whistleblower retaliation applies to “any employer,” not just public companies.
No administrative exhaustion: In contrast to SOX, Dodd-Frank permits a whistleblower to sue a current or former employer directly in federal district court without first exhausting administrative remedies at DOL.
Whistleblower Protections for SEC Whistleblowers
Read More Here
Corporate Transparency Act : Enforcement Suspended and New Rules to Come
FinCEN and the Department of the Treasury both provided updates this week regarding the Corporate Transparency Act.
On February 27, FinCEN announced that it would release an interim final rule before the current filing deadline of March 21. It will not issue any fines, penalties, or other enforcement actions against any companies (foreign or domestic) for failing to file or update their BOI reports by March 21. Any fines, penalties, or other enforcement actions will only proceed once the interim final rule becomes effective and the new deadlines in the interim final rule have passed.
On March 2, the Treasury Department provided a further update regarding the upcoming rule changes. The proposed rule is expected to narrow the CTA’s scope so that U.S. citizens and domestic reporting companies are exempt, and only foreign reporting companies will be required to comply.
SuperValu Wins False Claims Act Case with a “No Harm, No Foul” Jury Verdict
On March 5, 2025, SuperValu, Inc. (SuperValu), a grocery store chain that operates in-store pharmacies, was cleared of liability by a Central District of Illinois federal jury—finally quashing whistleblower claims that the company improperly over-billed the government and violated the False Claims Act (FCA). This jury verdict came after a long 14-year battle, which included a Supreme Court reversal of lower court decisions on the FCA’s scienter standard.
In 2006, SuperValu’s pharmacies began discounting generic drugs through a price-matching system (if a customer provided evidence of a cheaper price for certain drugs available at another pharmacy, SuperValu would match that price) and other loyalty programs. Many of SuperValu’s customers took advantage of these programs. However, when the company reported its “usual and customary” price to federal and state governments for reimbursement, SuperValu reported the much higher retail price of the drugs. After these programs ended, whistleblowers brought suit against SuperValu under the FCA’s qui tam provision. In the qui tam actions, plaintiffs alleged that SuperValu offered discounted pricing through these programs to so many customers that the discounted price was effectively their “usual and customary” price. As SuperValu did not offer the discounted pricing to Medicare and Medicaid, which were required by law to be charged the “usual and customary price,” the whistleblowers alleged SuperValu overcharged the government for years when seeking reimbursements for prescription drugs.
In 2020, the District Court granted SuperValu’s motion for summary judgment, holding that SuperValu had submitted false claims as defined under the FCA, but concluding that SuperValu did not possess the required scienter necessary to establish FCA liability. The government appealed to the Seventh Circuit, which affirmed the lower court’s decision. The Seventh Circuit applied a two-part test to determine if SuperValu knowingly or recklessly submitted false claims:
Was the defendant’s interpretation of law objectively reasonable (including not being ruled out by prior precedent); and
If the defendant’s interpretation was not objectively reasonable, did the defendant have a subjective belief the claims they were submitting were false?
If the defendant’s interpretation was not objectively reasonable, and the defendant had a subjective belief it was submitting false claims, the defendant knowingly or recklessly submitted false claims. The Seventh Circuit held that SuperValu’s interpretation of the law was objectively reasonable and, therefore, SuperValu did not possess the required scienter under the FCA.
In 2023, the Supreme Court reversed the Seventh Circuit, holding that, whether a defendant possessed scienter sufficient to satisfy the FCA requirements depended solely on that defendant’s subjective knowledge—doing away with the Seventh Circuit’s “objectiveness” test. Focusing on the plain language of the FCA, the Supreme Court held that, to prove a false claim, two elements must be satisfied: (1) the claim that was submitted was, in fact, false and (2) the defendant subjectively believed the claim was false.
Nearly fourteen years after its initial filing, the case returned to the District Court on remand from the Supreme Court for a jury trial. While the jury ultimately found that SuperValu did knowingly submit false claims under the Supreme Court’s scienter standard, the question of whether the jury would impose liability came down to whether the federal or state governments suffered damages due to SuperValu’s false claims. In a pre-trial motion, SuperValu argued that any evidence the plaintiffs offered of the alleged overpayments was evidence only of a gain to SuperValu—not a loss to the government. Because the government determines reimbursement rates under Medicare Part D plans, SuperValu argued that plaintiffs would have to prove that the alleged false claims changed the amount government actually paid and, thus, caused damages. It appears the jury accepted this argument. The jury unanimously decided the plaintiffs had not proved that either the federal or state governments suffered damages and, as a result, SuperValu was found “not liable.” After a long and tortured history, the whistleblowers’ claims were finally put to rest. The case ultimately ended with a “no harm, no foul” verdict, and SuperValu avoided liability under the FCA. The case suggests a potent line of defense for companies defending against FCA allegations.
What Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a False Claim
Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction which implies that the legislature was ignorant of the meaning of the language it employed.”[1]
However, there’s currently a split among the federal courts regarding how to interpret a phrase in a 15-year-old amendment to the Anti-Kickback Statute (AKS).[2] In 2010, Congress amended the AKS to provide that where the statute is violated, in addition to criminal penalties, any “claim that includes items or services resulting from [that] violation of [the AKS] constitutes a false or fraudulent claim for purposes of the [False Claims Act (FCA)].”[3] The circuit courts disagree over what it means for a claim to “result from” a violation of the AKS.
On February 18, 2025, the U.S. Court of Appeals for the First Circuit, in United States v. Regeneron Pharmaceuticals, held that to show a claim “results from” a violation of the AKS, the government must prove that a claim would not have been submitted “but for” the illegal kickback. [4] While this ruling aligns with recent decisions by the Sixth[5] and Eighth[6] Circuits, it conflicts with a Third Circuit decision[7] holding that the government must merely prove a “causal connection” between an illegal kickback and a claim being submitted for reimbursement. This Insight explores the courts’ approaches to evaluating what the words “resulting from” mean in the context of the AKS.
History of the Relationship Between the AKS and the FCA
The AKS makes it a crime to knowingly and willingly offer, pay, solicit, or receive any remuneration to induce referrals or services reimbursable by a federal health care program (e.g., Medicare, Medicaid). Each offense under the AKS is punishable by a fine of up to $100,000 and imprisonment for up to 10 years. Violators of the AKS can also be excluded from federal health care programs and face civil monetary penalties: (i) up to $50,000 and (ii) three times the amount of the remuneration in question.[8] Significantly, the 2010 amendment to the AKS clarified that a person or entity must act willfully to violate the statute, even though “a person need not have actual knowledge of [the AKS] or specific intent to commit a violation of [the AKS].” [9]
The FCA is the primary vehicle through which the government (on its own behalf and by virtue of the FCA private right of action provision) pursues fraud, waste, and abuse in the health care industry. Generally, the statute imposes liability on anyone who knowingly presents, or causes to be presented or conspires to present, a false or fraudulent claim for payment or approval.[10]
To establish a violation of the FCA, the government must prove by a “preponderance of the evidence”—a lesser standard than the criminal “beyond a reasonable doubt” standard—that a defendant “knowingly” violated the statute. The FCA defines the terms “knowing” and “knowingly” to mean that a person “(i) has actual knowledge of the information; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (ii) acts in reckless disregard of the truth or falsity of the information.” The statute further clarifies that proof of specific intent to defraud is not required.[11]
Before 2010, federal law did not specifically address whether a violation of the AKS could result in a claim being considered false for purposes of the FCA. For almost two decades, the government and qui tam relators attempted to “bootstrap” anti-kickback claims to the FCA to obtain civil penalties based on alleged AKS violations. This bootstrapping theory was premised on the argument that when a provider submits a claim to a federal health care program, the claim includes an implicit certification that the provider was in compliance with applicable laws, including the AKS.
For instance, in Roy v. Anthony,[12] a whistleblower sued under the FCA alleging that physicians in a medical practice referred patients to diagnostic centers in violation of the AKS. The defendants settled the case for more than $1.5 million following a district court decision holding that the plaintiff could prove that the charged claims were false because they were submitted in violation of the AKS. Similarly, the district court in Pogue v. American Healthcorp held that a violation of the AKS could constitute a false claim under the FCA if the whistleblower or the government could show that the defendants engaged in fraudulent conduct with the purpose of inducing payment from the government.[13]
In 2010, as part of the Patient Protection and Affordable Care Act,[14] Congress attempted to resolve the highly litigated issue of whether a violation of the AKS can serve as a basis for liability under the FCA by amending the AKS to state that a “claim that includes items or services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for purposes of the [FCA].”[15]
Split Among the Courts Interpreting the Causation Standard
Despite the 2010 amendment, the debate has not ended regarding the relationship between the AKS and the FCA, with the courts splitting on what it means for a claim to “result from” a violation of the AKS. The Third Circuit has held that the government must merely prove a “causal connection” between an illegal kickback and a claim being submitted for reimbursement, while the First, Sixth, and Eighth Circuits have adopted the stricter “but-for” standard of causation.
Third Circuit: The “Causal Connection” Standard
In 2017, in United States ex rel. Greenfield v. Medco Health Solutions Inc., the Third Circuit first examined this issue in a case where the qui tam relator argued that the defendant’s alleged kickback scheme amounted to a violation of the FCA because at least some referrals or recommendations were for Medicare beneficiaries and because the defendant falsely certified compliance with the AKS.[16]
Relying on the U.S. Supreme Court’s ruling in Burrage v. United States, the defendant argued that “resulting from” requires “proof the harm would not have occurred in the absence of—that is, but for—the defendant’s conduct.”[17] The government/qui tam relator responded that requiring but-for causation would lead to the “incongruous” result that a defendant could be convicted of criminal conduct under the AKS but be insulated from civil liability under the FCA.
In interpreting the 2010 amendment, the Third Circuit examined the legislative history surrounding its passage. Specifically, the court referenced language from the congressional record in which one senator explained that Congress wanted to “strengthen” actions under the FCA and “ensure that all claims resulting from illegal kickbacks are considered false claims for the purpose of civil action[s] under the False Claims Act.”[18] The court agreed with the government’s position, concluding that imposing a “but-for” standard “would hamper FCA cases under the provision even though Congress enacted it to strengthen[] whistleblower actions based on medical care kickbacks.”
While the Third Circuit sided with the government by rejecting a but-for causation standard, the court, nevertheless, held in favor of the defendant. The complaint alleged that (1) the defendant paid illegal kickbacks to Party A, (2) Party A forwarded that money to Party B, (3) Party B included the defendant as an approved provider for Party B’s members, (4) the defendant filed claims on behalf of 24 federally insured patients, and (5) the defendant violated the FCA because the defendant incorrectly certified that it did not pay any illegal kickbacks. The Third Circuit disagreed, relying on an Eleventh Circuit case holding that a plaintiff cannot “merely … describe a private scheme in detail but then … allege … that claims requesting illegal payments must have been submitted, were likely submitted[,] or should have been submitted to the Government.”[19] Instead, the government/relator must provide evidence of the actual submission of a false claim. In Medco, the Third Circuit held that even if it were to assume the defendant paid illegal kickbacks, “that is not enough to establish that the underlying care to any of the 24 patients was connected to a breach of the AKS; we must have some record evidence that shows a link between the alleged kickback and the medical received by at least one” of the patients.
First, Sixth, and Eighth Circuits: The “But-For” Causation Standard
While the Third Circuit refused to find the Supreme Court’s Burrage decision controlling, the First, Sixth, and Eighth Circuits relied on Burrage to support the but-for causation standard.
In 2022, in United States ex rel. Cairns v. DS Medical LLC,[20] the Eighth Circuit relied on Burrage, as well as on several dictionary definitions of the words/phrases “resulting” and “results from,” and concluded that these words require a “but-for” causal connection. The Eighth Circuit addressed the Third Circuit’s holding in Medco and declined to follow that case, rejecting the Third Circuit’s approach of relying on legislative history and “the drafters’ intentions.” The Eighth Circuit held that if Congress had not intended to impose this “but-for” causation standard, then it could have adopted a different standard such as “tainted by” or “provided in violation of.”
The following year, the Sixth Circuit, relying on Burrage and United States ex rel. Cairns v. DS Medical LLC, held that the government/whistleblowers needed to satisfy the but-for causation standard and ruled in favor of the defendants where there was no evidence that the alleged kickback arrangement changed any of the parties’ behaviors. In other words, regardless of the improper payments, the same referrals would have occurred, and the same claims would have been submitted to the federal government. [21]
The First Circuit recently joined the Eighth and Sixth Circuits in adopting the but-for causation standard. The First Circuit noted that while the Supreme Court has held that “as a result from” imposes a requirement of causality—meaning that the harm would not have occurred but for the conduct—“that reading serves as a default assumption, not an immutable rule.” Nevertheless, the First Circuit determined that nothing in the 2010 amendment contradicts the notion that “resulting from” requires proof of but-for causation.
While it agreed that the criminal provisions of the AKS do not include a causation requirement, the First Circuit observed that different evidentiary burdens can exist for claims being brought for purposes of criminal versus civil liability. The First Circuit concluded that although the AKS may criminalize kickbacks that do not ultimately cause a referral, a different evidentiary standard can and should be applied when the FCA is triggered. As a result, the First Circuit affirmed the lower court’s decision that “to demonstrate falsity under the 2010 amendment, the government must show that an illicit kickback was the but-for cause of a submitted claim.”
In light of this decision, a majority of the Circuits that have addressed this issue have adopted the “but-for” causation standard based on the 2010 amendment, leaving the Third Circuit as the only circuit court to adopt the more lenient “causal connection” standard. Notably, while three Circuits have now aligned on interpreting the “resulting from” language in the 2010 amendment to require but-for causation, this standard applies to those FCA cases based upon AKS violations that do not involve a false certification theory. These but-for cause decisions do not address causation in AKS-based FCA cases where the alleged falsity is a false certification of compliance with the AKS. This false certification theory remains viable, which the First Circuit specifically addressed in Regeneron.
Conclusion
Entities in the health care and life sciences industries facing allegations of AKS and FCA violations should be aware of the current state of the law and be prepared to vigorously challenge efforts by the government, or qui tam relators, to seek to deviate from the but-for causation standard.
Although the U.S. Supreme Court denied a petition to review this specific issue in 2023, it may once again be called upon to weigh in, as there inevitably will continue to be a division in how the courts interpret this “resulting from” language.
ENDNOTES
[1] Montclair v. Ramsdell, 107 U.S. 147 (1883).
[2] See 42 USC § 1320a-7b(b).
[3] See 42 USC § 1320a-7b(g) (emphasis added). The federal False Claims Act (FCA) can be found at 31 U.S.C. § 3729 et seq.
[4] United States v. Regeneron Pharmaceuticals, 2025 WL 520466 (1st Cir. Feb. 18, 2025).
[5] United States ex rel. Martin v. Hathaway, 63 F.4th 1043, 1052–55 (6th Cir. 2023).
[6] United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828, 834–35 (8th Cir. 2022).
[7] United States ex rel. Greenfield v. Medco Health Solutions Inc., 880 F.3d 89, 100 (3d Cir. 2018).
[8] See 42 U.S.C. § 1320a-7b(b).
[9] See 42 U.S.C. § 1320a-7b(h).
[10] See 31 U.S.C. § 3729(a)(1).
[11] See 31 U.S.C. § 3729(b)(1).
[12] See United States ex rel. Roy v. Anthony, No. C-1-93-0559 (S.D. Ohio 1994).
[13] See United States ex rel. Pogue v. American Healthcorp., Inc., 1995 WL 626514 (M.D. Tenn. Sept. 14, 1995); United States ex rel. Pogue v. American Healthcorp., Inc., 914 F. Supp. 1507 (1996).
[14] Patient Protection and Affordable Care Act (PL 111-148).
[15] Id. at § 6402(f)(1) codified at 42 U.S.C. § 1320a-7b(g).
[16] United States ex rel. Greenfield v. Medco Health Solutions Inc., 880 F.3d 89, 100 (3d Cir. 2018). It should be noted that, in this case, the government originally declined to intervene.
[17] Id. quoting Burrage v. United States, 134 S. Ct. 881, 887-888 (2014).
[18] Id. citing 155 Cong. Rec S10852, S10853 (daily ed October 28, 2009).
[19] Id. citing United States ex rel. Clausen v. Lab Corp. of Am., 290 F3d 1301, 1311 (11th Cir. 2002).
[20] United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828, 834–35 (8th Cir. 2022).
[21] United States ex rel. Martin v. Hathaway, 63 F.4th 1043, 1052–55 (6th Cir. 2023).
What DOJ’s New Focus on Immigration Enforcement Means for Businesses
The Department of Justice (DOJ) has announced its intention to expand the use of criminal statutes to address illegal immigration. This move underscores the administration’s commitment to enforcement initiatives that hold employers accountable for compliance failures.
This policy shift may result in companies facing criminal charges in cases that the DOJ has not previously pursued. This includes charges for harboring undocumented individuals, engaging in unlawful employment practices, and committing document fraud in the I-9 process.
Information will be gathered through various methods, including raids, I-9 Notices of Inspection, and document subpoenas. The directive mandates that DOJ prosecutors accept and pursue the most serious criminal violations referred by law enforcement agencies, with limited discretion to decline cases.
Employers should be prepared for site visits from the USCIS Fraud Detection and National Security (FDNS) Directorate. These visits are conducted to investigate compliance related to sponsored visas, typically H-1B visas. Although FDNS visits are nothing new, any form of misrepresentation now may be referred for further DOJ investigation. Companies should consider preparing their businesses and employees for site visits, conducting regular internal audits of their verification records, and ensuring their compliance practices are sound.
Employers can expect increased scrutiny and should be prepared for potential inspections and investigations.
China’s Supreme People’s Procuratorate Releases 2025 Work Report – 21,000 People Prosecuted For IP Crimes
On March 8, 2025, China’s Supreme People’s Procuratorate (SPP) released its 2025 Work Report at the 14th National People’s Congress. Regarding intellectual property, the SPC states that 21,000 people we prosecuted for IP crimes in 2024 and highlighted the trade secret case of Zhang, who was prosecuted under China’s version of the Economic Espionage Act. Other significant criminal IP cases were surprisingly not highlighted, like the 9-year prison sentence for criminal copyright infringement of Lego bricks.
The opening ceremony of the third session of the 14th National People’s Congress was held in the Great Hall of the People in Beijing.
The IP section from the SPP’s work report follows:
Serve innovation-driven development. Strengthen judicial protection of intellectual property rights, promote the cultivation and growth of emerging industries such as artificial intelligence and biomedicine, assist in the transformation and upgrading of traditional industries, and protect the development of new quality productivity in accordance with local conditions. We prosecuted 21,000 people for crimes such as infringement of trademark rights, patent rights, copyrights and trade secrets. In one case, Zhang and others illegally obtained a company’s core chip technology, and the Shanghai Procuratorate filed a public prosecution for suspected infringement of trade secrets. We handled 4,219 civil, administrative and public interest litigation cases involving intellectual property rights, protect the legitimate rights and interests of scientific and technological innovation entities in accordance with the law, and serve high-level scientific and technological self-reliance.
The full text is available here (Chinese only)
CTA Enforcement Halted Again: Treasury Department Suspends CTA Requirements for Domestic Reporting Companies
In yet another update to the ongoing saga of the Corporate Transparency Act (CTA), the Financial Crimes Enforcement Network (FinCEN), the agency of the U.S. Department of the Treasury (“Treasury Department”) that enforces the CTA, announced on February 27, 2025, that it would not issue any fines or penalties or take any other enforcement actions against companies for a failure to provide beneficial ownership information (BOI) until a new interim final rule on the CTA is released.
On March 2, 2025, the Treasury Department provided further guidance on the CTA, announcing that it would halt enforcement of the CTA with respect to U.S. citizens and domestic reporting companies.
In its press release announcing this update, the Treasury Department stated that it will not enforce any penalties or fines associated with the BOI reporting requirements under the existing CTA rules; however, it will also issue a new proposed rule (to be released no later than March 21, 2025, according to FinCEN’s February 27, 2025, announcement) that will narrow the scope of the reporting requirements under the CTA to “foreign reporting companies only.”
Under the CTA, a “foreign reporting company” is any entity that is formed under the law of a foreign country and has registered to do business in the United States by the filing of a document with a secretary of state or any similar office, while a “domestic reporting company” is any entity that is formed in the United States by the filing of a document with a secretary of state or any similar office. We note, however, that the Treasury Department could seek to modify these definitions as part of its new proposed rule.
The immediate takeaway, based on this guidance from the Treasury Department, is that all domestic reporting companies are no longer required to file BOI and will not be subject to liability for not filing.
We will continue to monitor additional developments regarding the CTA, including the expected further guidance from the Treasury Department, to determine what the CTA filing requirements and deadlines will be for foreign reporting companies.