Grassley Defends Constitutionality of False Claims Act’s Qui Tam Provisions in Amicus Brief
In an amicus brief filed on January 15, Senator Chuck Grassley (R-IA) urges the Eleventh Circuit to reverse a district court ruling which held that the False Claims Act’s qui tam provisions are unconstitutional.
Grassley, who authored the 1986 amendments which modernized the FCA, states that “the False Claims Act is our nation’s single greatest tool to fight waste, fraud and abuse” and calls the Middle District of Florida’s decision in Zafirov v. Florida Medical Associations a “flawed decision.”
In September, the Middle District of Florida dismissed whistleblower Claire Zafirov’s qui tam lawsuit on the grounds that the FCA’s qui tam provisions are unconstitutional as they violate the Appointments Clause of Article II of the Constitution.
In his brief, Grassley lays out the long-history of qui tam laws and details a number of qui tam provisions enacted by the First Congress. He criticizes the district court for discarding this history despite the Supreme Court’s heavy reliance on it in its decision in Vermont Agency of Nat. Res. v. United States ex rel. Stevens, which held that the FCA’s qui tam provisions do not violate Article III of the Constitution.
“The First Congress that enacted numerous statutes that featured qui tam provisions made clear that, at the time of the founding, the legislature believed that the limited rights granted relators fell within the Constitutional separation of powers many of them had personally fashioned,” Grassley’s brief states.
In the brief, Grassley also notes that “every court to have addressed the issue has concluded that the qui tam provision is in accordance with the Constitutional separation of powers.”
He further emphasizes the immense success of the FCA’s qui tam provisions in incentivizing whistleblowers to come forward and expose otherwise hard-to-detect frauds, deter would-be fraudsters, and protect the public from harm.
As Grassley notes in his brief, “the FCA is a resounding success, as Congress and the Executive Branch have both acknowledged.” According to newly released statistics from the Department of Justice (DOJ), since the FCA was modernized in 1986, qui tam lawsuits have resulted in over $55 billion in recoveries of taxpayer dollars.
Grassley’s brief joins a brief filed by the U.S. government in urging the Eleventh Circuit to reverse the district court ruling. In its brief, the government claims that the Stevens decision “makes clear that relators do not exercise Executive power when they sue under the Act… Rather, they are pursuing a private interest in the money they will obtain if their suit prevails.”
It further states that “the historical record.. suggests that all three branches of the early American government accepted qui tam statutes as an established feature of the legal system.”
During her Senate confirmation hearing on January 15, Senator Grassley asked Pam Bondi, nominee to be the Attorney General, if she would commit to defending the constitutionality of the FCA.
“I would defend the constitutionality of course of the False Claims Act,” Bondi stated. “The False Claims Act is so important, especially by what you said with whistleblowers.”
DOJ’s False Claims Act Recoveries Top $2.9 Billion in FY 2024, but Health Care Numbers Dip—What Could FY 2025 Hold for Health Care Enforcement?
On January 15, 2025, the U.S. Department of Justice (DOJ) issued a press release announcing its fiscal year (FY) 2024 False Claims Act (FCA) recoveries and reported that settlements and judgments exceeded $2.9 billion in 2024—up from $2.68 billion in FY 2023.
Recoveries from entities in the health care and life sciences industries continue to represent the lion’s share of the dollars. However, health care recoveries have dropped year over year, and 2024 saw a decrease in the number of cases pursued by the DOJ on its own. What does the future hold as we look forward to a new administration? History might provide some interesting guidance.
Overview of the Statistics
While the 423 FCA cases filed by the DOJ in FY 2024 represented a marked decrease from the 505 FCA cases filed the previous year, FY 2024 saw the highest number of qui tam actions filed in history. FY 2024, coincidentally, ended on the same day (September 30, 2024) that a Florida judge ruled in U.S. ex rel. Zafirov v. Florida Medical Associates that the qui tam provisions of the FCA were unconstitutional.
Qui tam relators, or whistleblowers, filed 979 suits in FY 2024, up from 713 in FY 2023 and eclipsing the prior record of 757 filings set in FY 2013.
Whistleblower and DOJ cases combined resulted in 558 settlements and judgments, on par with 566 last year.
Counting the $2.9 billion recovered in FY 2024, total recoveries under the FCA since the 1986 amendments now exceed $78 billion and have exceeded $2 billion annually for 16 consecutive years.
Health Care Statistics
While several of the health care statistics dipped slightly, recoveries from the health care sector remained steady at $1.68 billion (compared to $1.86 billion in FY 2023) and drove the overall FCA recovery figures.
While the FCA statistics show overall increases in total fraud recoveries and the number of cases filed by whistleblowers in FY 2024, the health care statistics portray a slightly different picture. While more health care cases were filed by relators in FY 2024 than in FY 2023, the number of cases brought by the DOJ, on its own, dropped by more than 10 percent compared to FY 2023. Other health care statistics that dropped in FY 2024 compared to FY 2023 included:
total health care fraud recoveries,
recoveries in cases pursued by the government,
recoveries in cases in which the government intervened, and
recoveries in cases where relators pursued matters on their own.
In DOJ’s press release announcing the FCA recoveries, the agency reaffirmed its commitment to enforcement in the health care sector, highlighting key recoveries in the following areas:
health care entities contributing to the opioid crisis;
providers billing federal health care programs for medically unnecessary services and substandard care;
cases alleging false claims in the Medicare Advantage program;
matters involving unlawful kickbacks and Stark Law violations;
pandemic-related fraud (including cases involving improper payments under the Paycheck Protection Program and alleged fraud affecting Medicare and other federal health care programs for services related to COVID-19 testing and treatment); and
cybersecurity enforcement and holding contractors accountable for compliance with applicable cybersecurity requirements (one example was a case against the Georgia Institute of Technology and Georgia Tech Research Corp., which we covered in an earlier blog post).
What to Expect in FY 2025
As a general matter, the FY 2024 statistics demonstrate that FCA enforcement continued to be a top DOJ priority, particularly within the health care sector.
As we look ahead to the incoming Trump administration, it is noteworthy that the first Trump administration saw almost 370 more health care FCA cases brought by relators than those filed during the Biden administration. The first Trump administration also saw the highest number of health care-related FCA cases brought in a single year by the DOJ. History would suggest a continued focus on health-care related FCA enforcement during President Trump’s second term.
Epstein Becker Green Attorney Ann W. Parks contributed to the preparation of this post.
2024 False Claims Act Statistics Show More Cases Filed Than Ever Before
The Justice Department released its annual False Claims Act statistics on Wednesday, January 15, detailing the number of cases filed, recoveries made, and relators’ shares awarded in fiscal year 2024. The government recovered $2.9 billion dollars in 2024, with 57% of that total coming from healthcare cases, 3% from defense spending cases, and the remainder from other actions. Seventy-five percent of recoveries came from qui tam actions in which the government intervened and 17% came from cases initiated by the Justice Department, while qui tam actions where the government declined to intervene resulted in only 7% of the year’s recoveries.
2024 also saw more new FCA cases initiated than ever before. There were 1,402 new matters: 423 initiated by the government and a record-shattering 979 initiated by relators.
While the overall total recoveries increased by $133 million from the year prior, the types of cases driving the number have shifted slightly. Healthcare recoveries are down $184 million from last year and are the lowest they have been since 2009. Defense spending recoveries are down $464 million and are the lowest they have been in the last several years, though DOJ noted in its press release that a $428 million defense settlement—the second largest in history—came in just after the close of the fiscal year. While those traditional stalwarts of FCA recoveries lagged in 2024, DOJ more than made up for them in recoveries in non-healthcare or defense cases. Recoveries in other cases increased $781 million over the prior year and were the highest they have been in almost a decade.
It is not immediately clear what drove the uptick in non-healthcare and defense cases, though pandemic-related fraud claims accounted for at least $250 million of the recoveries. A menagerie of claims related to other government agencies, programs, and grants also appear to have contributed, including claims related to General Services Administration contracts, Housing and Urban Development grant funds, underpayment of royalties owed for oil and natural gas on federal lands, and Federal Emergency Management Agency (FEMA) projects.
Though the government increased its recoveries, it shared less of that money with whistleblowers. Relators received $50 million less than they did in fiscal year 2023. For qui tam actions in which DOJ intervened, it provided an average of 15.7% of the recoveries to the relator, which is the second-lowest relator share percentage since 2012.
In its press release touting the year-end statistics, the Justice Department highlighted healthcare recoveries in areas it has focused on in recent years, including opioid-related cases, matters alleging unnecessary services and substandard care, Medicare Advantage cases, kickbacks, and Stark Law violations. Though it did not appear to drive significant numbers in 2024, the government also highlighted its emerging cybersecurity initiative to promote cybersecurity requirements for government contractors.
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DOJ Reports Nearly $3 Billion in FCA Settlements, Judgments for FY 2024
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DOJ Reports Nearly $3 Billion in FCA Settlements, Judgments for FY 2024
On January 15, the US Department of Justice (DOJ) reported that settlements and judgments under the False Claims Act (FCA) totaled more than $2.9 billion in fiscal year 2024. The government and whistleblowers were involved in 558 FCA settlements and judgments, marking the second-highest total after fiscal year 2023’s record of 566 recoveries. Whistleblowers also filed the highest number ever of qui tam lawsuits, totaling 979 this past fiscal year.
Health care fraud accounted for the majority of FCA settlements and judgments. Over $1.67 billion of the FCA settlements and judgments reported in fiscal year 2024 related to health care matters, including managed care providers, hospitals, pharmacies and pharmaceutical companies, and physicians. The cases related to the health care industry involved, among other things, the opioid epidemic, unnecessary services and substandard care, Medicare Advantage matters, and unlawful kickbacks.
The DOJ statistics sheet can be found here and the press release can be found here.
Pharmacy to Pay $625,000 to Resolve FCA Allegations
On January 13, a settlement was finalized between a pharmacy located in New Jersey, Medsinbox Pharmacy LTC LLC, and the federal and New Jersey state governments. Pursuant to the settlement agreement, Medsinbox agreed to pay $625,000 to settle allegations that it violated the FCA by billing Medicare and Medicaid for prescriptions that it never actually distributed.
The government alleged that between 2019 and 2022, Medsinbox knowingly submitted claims for reimbursement to the federal Medicare and Medicaid programs for medications that it never actually gave to beneficiaries. According to the government, Medsinbox inventory records indicate that the pharmacy never purchased the amount of prescriptions that it claims to have filled and billed to Medicare and Medicaid programs.
The settlement is available here and the DOJ press release can be found here.
Firm Founder Pleads Guilty for Role in $9 Million Cryptocurrency Investment Fraud
On January 9, Travis Ford, the founder of a cryptocurrency investment firm, pleaded guilty for his role in a $9 million fraud conspiracy. Ford pleaded guilty to one count of conspiracy to commit wire fraud, for which he faces up to five years in prison.
According to the government, Ford was the co-founder of cryptocurrency investment firm Wolf Capital Crypto Trading LLC. As alleged, Ford made false promises to solicit investments through social media and other internet platforms, including by purporting to be a sophisticated trader able to deliver returns of 1-2% daily despite admitting that those returns were not realistic. The government alleged that Wolf Capital raised $9.4 million through Ford’s conduct and Ford then misappropriated the investor funds for his own use.
The DOJ press release can be found here.
US Department of Justice Announces US$2.9 Billion in Fiscal Year 2024 False Claims Act Recoveries
On 15 January 2025, the US Department of Justice (DOJ) published its report (Report) announcing civil recoveries under the False Claims Act (FCA) for Fiscal Year (FY) 2024. The recoveries for FY 2024 exceeded US$2.9 billion, approximately US$1.7 billion of which involved the health care industry. The US government has now collected over US$78 billion in recoveries under the FCA since the statute was amended in 1986 to allow for treble damages and increased incentives for whistleblowers. Notably, the 979 qui tam lawsuits filed in FY 2024 marked the highest number in a single year; and the 558 settlements and judgments trailed only just behind the record number set in FY 2023.
As with FY 2023, qui tam cases comprised the largest portion of recoveries, with over 83% (US$2.4 billion) stemming from whistleblower actions. The government paid over US$400 million to whistleblowers in relation to these FY 2024 recoveries. Of the record-setting 979 qui tam suits that were filed in FY 2024, 370 were health care focused.
DOJ also highlighted its “key enforcement priorities” for FY 2024 and provided representative examples. The enforcement priorities included health care fraud, military procurement fraud, pandemic fraud, and cybersecurity fraud. As with prior years, health care fraud was the principal source of FCA recoveries, which included recoveries relating to Medicare Advantage fraud, billing for unnecessary services and substandard care, opioid epidemic-related fraud, kickback schemes, and Stark Law violations.
Health Care Fraud
With Medicare Advantage, also known as Medicare Part C, having become the largest component of the Medicare program, the government continued its focus on Medicare Advantage fraud. In FY 2024, the government secured a substantial recovery from a provider that allegedly paid kickbacks to third-party insurance agents in exchange for recruiting senior citizens to the provider’s primary care clinics. DOJ also highlighted that it is continuing to litigate a number of cases against Medicare Advantage Organizations.
DOJ obtained substantial recoveries from providers who allegedly improperly billed for medically unnecessary services and substandard care. Additionally, the government has continued to focus on opioid crisis-related fraud, with several substantial recoveries against pharmaceutical companies and individual physicians.
In a carry-over from FY 2023, some of the largest health care recoveries in FY 2024 resulted from alleged unlawful kickback schemes and Stark Law violations. The kickback schemes ranged from payments to purportedly induce referrals of dialysis patients, to medical directorships that were intended to induce patient referrals. As to the Stark Law, DOJ highlighted a US$345 million settlement to resolve allegations that a health care network paid compensation to certain physician groups far above fair market value and awarded bonuses tied to referral volume.
Other Enforcement Priorities
In addition to health care-specific recoveries, the government recovered significant funds stemming from military procurement fraud, pandemic fraud, and cyber fraud. The military procurement fraud recoveries included a US$70 million settlement against a contractor to resolve allegations that they overcharged the US Navy for spare parts and materials needed to repair and maintain aircraft used to train naval aviators. Of note, military procurement fraud recoveries could have been much higher in FY 2024, however, a US$428 million settlement with a defense contractor occurred on 16 October 2024, putting that recovery in FY 2025.
The government also resolved an estimated 250 cases, totaling over US$250 million, in connection with pandemic-related fraud. As with FY 2023, the pandemic fraud largely stemmed from the submission of inaccurate information in PPP loan applications, though the DOJ also highlighted a US$12 million recovery that resolved allegations of false claims for COVID-19 testing that were billed to the Health Resources and Services Administration’s Uninsured Program.
In October 2021, DOJ announced its Civil Cyber-Fraud Initiative with the goal of pursuing companies who receive federal funds while failing to follow required cybersecurity standards. In FY 2024, the government entered into several recoveries under the Civil Cyber-Fraud Initiative. DOJ also highlighted a complaint-in-intervention that was filed against a research institution alleging that the defendants had failed to meet cybersecurity requirements in connection with Department of Defense contracts.
Whistleblower Suits
Given the record-setting number of qui tam cases filed in FY 2024, it will be important to continue to monitor developments regarding the constitutionality of the qui tam provisions. On 30 September 2024, a judge in the US District Court for the Middle District of Florida held that the qui tam provisions of the FCA violate the Appointments Clause of Article II of the US Constitution. This first-of-its-kind decision has sparked a wave of filings by the defense bar. With the Middle District of Florida’s decision on appeal, there are sure to be many developments on this issue in the coming months.
The FY 2024 settlements and judgments provide an insight into the government’s enforcement priorities and potential future enforcement areas. The firm’s forthcoming article The False Claims Act and Health Care: 2024 Recoveries and 2025 Outlook will provide an in-depth analysis of the 2024 recoveries, as well as some key enforcement areas to look out for in 2025.
Bondi and Bessent Affirm Support for Whistleblowers in Confirmation Hearings
During their Senate confirmation hearings, both Pam Bondi, nominee for Attorney General, and Scott Bessent, nominee for Treasury secretary, affirmed their support for whistleblowers in response to questions from Senator Chuck Grassley.
Bondi Promises to Defend Constitutionality of False Claims Act
During Bondi’s confirmation hearing on January 15, Senate Grassley asked if she believed that the False Claims Act is constitutional and if she would commit to continuing the Department of Justice’s defense of its constitutionality. Grassley spoke about how, thanks in large part to “patriotic whistleblowers,” the False Claims Act has resulted in over $78 billion in collections for the government since 1986.
“I would defend the constitutionality of course of the False Claims Act,” Bondi stated. “The False Claims Act is so important, especially by what you said with whistleblowers.”
The constitutionality of the False Claims Act’s qui tam provisions have faced challenges recently. In September, the U.S. District Court for the Middle District of Florida ruled that the qui tam provisions are unconstitutional because they violate the Appointments Clause of Article II. The court ruled that by filing a qui tam lawsuit alleging Medicare fraud, whistleblower Clarissa Zafirov was granted “core executive power” without any “proper appointment under the Constitution.”
The U.S. government is urging the Eleventh Circuit to reverse the district judge’s “outlier ruling,” noting in a brief that “other than the district court here, every court to have addressed the constitutionality of the False Claims Act’s qui tam provisions has upheld them.”
Under the False Claims Act’s qui tam provisions, individuals may file lawsuits alleging government contracting fraud on behalf of the United States. The government then has the ability to intervene and take over the case, intervene and dismiss the case, or not intervene and let the whistleblower proceed with the suit. In successful qui tam cases, regardless of whether the government intervenes, whistleblowers are eligible to receive between 15 and 30% of the settlement or judgment.
Since the False Claims Act’s qui tam provisions were amended in 1986, the government has recovered over $78 billion, with more than $55 billion stemming from qui tam whistleblower suits. Striking down the constitutionality of qui tam would thus cripple the most important law protecting taxpayer funds from fraud.
Bessent States He will Support IRS Whistleblower Program
During Bessent’s confirmation hearing on January 16, Senator Grassley brought up the importance of the Internal Revenue Service (IRS) Whistleblower Program, noting that since it was established in 2006 ““it’s brought $6 billion back into the federal treasury.”
“This program could raise billions more if the IRS would use it to its full potential,” Grassley stated. “So I hope I can count on you, if you’re confirmed, to be supportive of this whistleblower program and work to ensure its full use to its full potential.”
“Senator Grassley, we are in complete alignment on this program,” Bessent said in response.
Through the IRS Whistleblower Program, qualified whistleblowers, individuals who voluntarily provide original information that leads to a successful IRS action, are eligible to receive monetary awards of 15-30% of the money collected thanks to their disclosure.
The program, which revolutionized tax enforcement by incentivizing insiders to come forward and disclose hard-to-detect misconduct, has struggled in recent years as delays have grown and payouts to whistleblowers have dropped. While recent administrative reforms have strengthened the program, advocates believe that it has even more potential.
EnforceMintz — Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues
In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop the FCA scienter standard addressed in 2023 by the Supreme Court in its important SuperValu decision. We also look at decisions that have accepted the invitation of three Supreme Court justices to reexamine the constitutionality of the FCA’s qui tam provisions. Finally, a circuit split on the interpretation of “causation” for FCA suits based on alleged violations of the Anti-Kickback Statute (AKS) remains unresolved, pending a decision from the First Circuit.
Post-SuperValu Developments Concerning the FCA’s Scienter Standard
An essential element of any FCA claim is “knowledge” that the submission of claims was “false or fraudulent.” By statute, the FCA defines “knowledge” to mean that a person acted with (i) actual knowledge, (ii) deliberate ignorance, or (iii) reckless disregard with respect to the truth or falsity of the information at issue. This is the FCA’s intent or scienter standard. Last year, in SuperValu, the Supreme Court held that the FCA’s “knowledge” element is based on subjective intent and not, as a number of circuits had previously held, on a defendant’s “objectively reasonable” interpretation of an ambiguous legal or regulatory issue.1 We previously discussed the SuperValu case (here and here) and analyzed the decision’s implications in last year’s issue of EnforceMintz.
The Supreme Court explained that the FCA’s scienter requirement could be met by showing (i) “deliberate ignorance,” meaning that a defendant had knowledge of a “substantial risk” that its statements were false but “intentionally avoid[ed]” a relevant legal or regulatory requirement; or (ii) “reckless disregard,” meaning that a defendant understood that there was a “substantial and unjustifiable risk” that its claims were false but submitted the claims anyway. While the Supreme Court did not define how lower courts might determine which risks are “substantial” or “unjustifiable,” these two new glosses on “deliberate ignorance” and “reckless disregard” offer some guidance to providers and companies seeking to avoid exposure to FCA liability through well-designed compliance programs.
SuperValu may have been initially understood as a clear-cut victory for the United States and private whistleblowers who bring actions under the qui tam provisions of the FCA. Generally speaking, in litigation, a defendant’s subjective knowledge is often a question of fact, which makes it difficult for defendants to win a motion to dismiss on the basis of whether a complaint adequately alleges knowledge. But as decisions from the past year demonstrate, that is not the full story, for two reasons.
First, even after SuperValu, courts have been willing to grant motions to dismiss on scienter grounds. For example, in August 2024, a federal district court granted a pharmaceutical manufacturer’s motion to dismiss an FCA complaint for failure to adequately allege scienter.2 In US ex rel. Sheldon v. Forest Laboratories, LLC, the relator alleged that Forest Laboratories overcharged the government in violation of the FCA because it did not include certain price concessions in calculating “best price,” as that term was defined by statute. The court found the “best price” definition “no more informative than the hypothetical instruction in [SuperValu] to drive at a ‘reasonable’ speed.”3 As such, the court found that the defendant’s alleged familiarity with such vague instructions did not provide a basis to attribute a culpable mental state to the drug manufacturer.
Second, in June 2024, the Supreme Court decided Loper Bright Enterprises v. Raimondo, ending the era of “Chevron deference” in which courts deferred to an agency’s interpretation of an ambiguous statute.4 This decision may lend support to FCA defendants in cases where the conduct at issue allegedly violated an ambiguous statutory or regulatory requirement. Often in FCA cases, the United States or a private relator attempts to establish scienter by showing an FCA defendant’s knowledge of statutory or regulatory requirements or agency guidance. After Loper Bright, a provider or company facing ambiguous or complex statutory or regulatory requirements can now demonstrate that it subjectively believed it was not taking “substantial and unjustifiable risk” that its claims were false based on the controlling statutory text, without undue deference to an agency’s interpretation. For example, analyzing Stark Law compliance often requires a review of layers of exceptions to complex statutory or regulatory prohibitions. Loper Bright may help provide a defense as to both scienter and falsity where theories of liability are premised on noncompliance with a web of statutory requirements, regulations, and complex agency guidance.
As we previously discussed (here), these case law developments highlight three implications for health care and life sciences companies seeking to minimize FCA exposure or to defend against an FCA investigation or litigation:
Providers and companies should seek to minimize potential FCA exposure by documenting interpretations of ambiguous legal requirements or regulations based on all available advice, communications with agencies or payors, and any other information when making business decisions that involve claims to federal programs or federal funds.
In the event of an FCA investigation, strong compliance functions and a clear record showing the entity’s lack of a subjective belief that it was submitting false or fraudulent claims, or taking an unjustified risk of doing so, may help persuade the government to decline to intervene in an FCA lawsuit.
As Sheldon demonstrates, once in litigation, a scienter-based motion to dismiss argument as well as summary judgment opportunities may still be available, despite SuperValu’s subjective intent holding.
While scienter issues often raise disputed factual questions, that is not always the case, as demonstrated by developments in FCA case law since SuperValu.
Successful Constitutional Challenges in FCA Cases Under Article II and the Eighth Amendment
For the first time in two decades, the issue of the constitutionality of the FCA’s qui tam provisions is squarely before the federal courts. In 2024, defendants raised successful constitutional challenges in cases involving large FCA penalties. Given these results, constitutional questions will likely remain a hot-button issue in 2025, particularly in cases where the government declines to intervene.
Zafirov and the Constitutionality of the FCA’s Qui Tam Provisions
In September 2024, a federal district court held in US ex rel. Zafirov v. Fla. Med. Assocs., LLC that the FCA’s qui tam provisions violate the Appointments Clause of Article II of the Constitution.5
Public officials who exercise “significant authority” under federal law and “occupy a continuing position established by law” are “Officers” who must be appointed consistent with the requirements of Article II, Section 2. In considering whether FCA relators are “Officers”, the court observed that “[a]n FCA relator’s authority markedly deviates from the constitutional norm.” The court explained that the qui tam provisions permit anyone “wherever situated, however motivated, and however financed” to perform a “traditional, exclusive [state] function by appointing themselves as the federal government’s avatar in litigation.”6 The court thus concluded that arrangement violates the Appointments Clause because it permits unaccountable, unsworn private actors to exercise core executive power with substantial consequences for the public. Finding the relator in Zafirov was unconstitutionally appointed, the court granted the defendants’ motion for judgment on the pleadings and dismissed the case with prejudice.
In our prior discussion (here), we explained how Zafirov followed from Justice Thomas’s dissent in US ex rel. Polansky v. Executive Health Resources, which noted the “substantial arguments” that the FCA’s qui tam provisions may be “inconsistent with Article II.” Two other justices agreed with Justice Thomas’s suggestion that the Court should consider the constitutional question in an appropriate case.
The United States and the relator appealed the Zafirov decision to the Eleventh Circuit. As of the date of this publication, briefing is in progress. The government made four particularly noteworthy arguments in its opening brief. First, the government argued that qui tam relators pursue “private interests” assigned by the FCA but do not exercise executive power. Second, the government argued that the qui tam provisions are not subject to the Appointments Clause because relators are not a part of the federal government. Third, even if the Appointments Clause applies, the government argued that relators (i) do not exercise “significant authority” because they are not part of the government workforce and the government retains supervisory authority over declined FCA cases; and (ii) do not “occupy a continuing position established by law” because the role of a qui tam relator is time-limited, case-specific, and involves interests that are personal in nature. Finally, the government argued that, even if the district court’s ruling in Zafirov is affirmed, the decision should be limited only to declined cases and should not extend to matters where the government has intervened or is considering whether to intervene. The defendants’ brief will be filed in the first quarter of 2025 and a decision is expected by the end of 2025.
If Zafirov is affirmed, that would create a circuit split on the constitutionality of the qui tam provisions, which would greatly increase the odds of Supreme Court review. In cases decided between 1993 and 2002, the Second, Fifth, Sixth, Ninth, and Tenth Circuits rejected Article II constitutional challenges to the FCA’s qui tam provisions, so Zafirov’s impact may be limited in those jurisdictions. But in circuits where the issue has not been decided, and to preserve the argument in circuits that previously rejected Article II challenges, defendants are raising the constitutional arguments via motions to dismiss, motions for judgment on the pleadings, and in affirmative or general defenses.
For example, in one recent declined FCA lawsuit pending in a federal district court within the Eleventh Circuit, a defendant Medicare Advantage Organization moved to dismiss, leading its brief with the argument that such relator-driven qui tam suits violate Article II of the Constitution.7 Defendants have made similar arguments in other jurisdictions as well.8
The success of these arguments remains to be seen. FCA defendants raising the constitutional argument should be aware of the notice requirements of Federal Rule of Civil Procedure 5.1, which requires that a party filing a pleading or motion drawing into question the constitutionality of a federal statute promptly file a “notice of constitutional question” with the court and serve that notice on Attorney General of the United States.
In response to FCA defendants’ emerging reliance on Zafirov, the United States has not hesitated to step in to defend the constitutionality of the FCA’s qui tam provisions in previously declined cases. For example, in US ex rel. Gill v. CVS Health Corp., DOJ initially declined to intervene in an FCA lawsuit involving over $200 million in alleged damages from overpayments and over-billing federal programs and commercial payors.9 After Zafirov was decided, the CVS defendants filed a Rule 5.1 notice of constitutional challenge, arguing that the FCA qui tam provisions violated separation of powers principles and Article II of the US Constitution. The CVS defendants also asserted those defenses in their answer to the complaint. The CVS defendants’ Rule 5.1 notice prompted the government to reverse course and intervene “for the limited purpose of defending the constitutionality of the qui tam provisions” of the FCA.
These Article II challenges to the qui tam provisions could significantly impact FCA cases, especially qui tam litigation where the United States previously declined to intervene. We will continue to monitor this issue as it develops in 2025.
Eighth Amendment Challenges to Excessive FCA Penalties
In July, the Eighth Circuit vacated a roughly $6.5 million FCA award, holding that the amount violated the Eighth Amendment’s Excessive Fines Clause.10 In Grant ex rel. US v. Zorn, a medical practitioner filed a qui tam action against the co-owner of a sleep disorders center, alleging that the defendant overbilled federal and state programs for patient visits and engaged in a kickback scheme. After trial, the district court determined that the 1,050 false claims the defendant had submitted to the government resulted in roughly $86,000 in actual damages, which was then trebled to about $259,000. Then, the court imposed a per-claim civil penalty, which added almost $7.7 million to the total award.
Citing the Eighth Amendment’s Excessive Fines Clause and the Supreme Court’s prior invalidation of punitive damages awards that far outpace actual damages, the district court reduced the penalties to $6.47 million. The district court thus endorsed a ratio in which the penalty amounts were 25 times greater than actual damages.
On appeal, however, the Eighth Circuit in Grant vacated the punitive damages award, holding that the application of both treble damages and per-claim civil penalties violated the Eighth Amendment’s Excessive Fine Clause. The court reasoned that the punitive sanction was “grossly disproportional” to the conduct at issue and that the Eight Circuit had previously rejected double-digit multipliers where there was a small economic loss and no evidence of danger to health and safety.
The Grant decision bolsters defendants’ arguments for lower penalty awards in FCA cases where the penalties imposed far exceed actual damages. These arguments are more likely to succeed in cases where the only harm alleged is purely economic.
The Unresolved Circuit Split on the Causation Standard for AKS-Based FCA Claims
As we discussed in last year’s edition of EnforceMintz, a significant circuit split is developing on the causation standard applicable to FCA claims based on violations of the AKS. Specifically, section (g) of the AKS states 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].”11 The issue in this circuit split is whether the submission of a claim to the government “result[s] from” a kickback only if it would not have been submitted “but for” the kickback.
In July 2024, the First Circuit heard oral argument on the FCA-AKS causation issue in United States v. Regeneron Pharmaceuticals, Inc.12 As of the date of publication of this article, the First Circuit’s decision is pending.
In Regeneron, the government appealed the district court’s holding that a standard of “but for” causation applied to FCA lawsuits premised on AKS violations. The district court’s holding was consistent with recent decisions from the Sixth and Eighth Circuits (which we previously discussed here) applying the plain language of section (g) of the AKS to require a showing of “but for” causation. On appeal, the government argued that a broader proximate cause standard applies, requiring only “some sort of causal connection.” That view, which has been endorsed by the Third Circuit, is based on the legislative history of the 2010 amendment that added the “resulting from” language in section (g) of the AKS.
At oral argument in Regeneron, Judge Kayatta challenged the government’s expansive view of the causation standard based on legislative intent. Judge Kayatta asked whether causation would be met in a situation where a hospital sent a vendor 10,000 claims in one year, then received a kickback, and then sent fewer claims in the following year. In response, the government argued that each and every claim in year two would be tainted by a kickback, even though the volume of claims decreased post-kickback. Perhaps tellingly, Judge Kayatta found that to be an “odd” outcome.
However the First Circuit rules, the circuit split will deepen, thereby increasing the likelihood that the causation standard question will rise to the Supreme Court. In the meantime, health care and life science entities facing FCA scrutiny based on AKS theories should closely monitor this emerging area. The applicable causation standard can have major implications on FCA exposure and potential damages.
ENDNOTES
[1] US ex rel. Schutte v. SuperValu Inc., 143 S. Ct. 1391, 1399 (2023).
[2] US ex rel. Sheldon v. Forest Laboratories, LLC, No. 1:14-cv-02535, 2024 US Dist. LEXIS 129331, at *79-80 (D. Md. July 23, 2024), appeal filed, No. 24-1793 (4th Cir. Aug. 21, 2024).
[3] Id. at 63.
[4] Loper Bright Enters. v. Raimondo, 603 US ___, 144 S. Ct. 2244 (2024).
[5] US ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A., No. 8:19-cv-01236-KKM, 2024 US Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024).
[6] Id. at *58-59 (internal quotations omitted).
[7] See Gonite v. UnitedHealthCare of Ga., Inc., et al., No. 19-246 (M.D. Ga. Oct. 11, 2024), ECF 69.
[8] See, e.g., US ex rel. Kenly Emergency Med. Corp. v. SCP Health, No. 3:20-cv-3274 (N.D. Cal. Dec. 13, 2024), ECF 74; Omni HealthCare Inc., et al v. North Brevard Cty. Hosp. Dist., et al., No. 6:22-cv-00696 (M.D. Fla. Nov. 28, 2024), ECF 87; US ex rel. Sullivan, et al. v. Murphy Med. Ctr., Inc., et al., No. 1:21-cv-219-MR (W.D.N.C. Oct. 25, 2024), ECF 85; US ex rel. Eckert v. Sci Tech. Inc and Sanmina Corp., No. 20-cv-1443 (D.D.C. Oct. 7, 2024), ECF 34-1.
[9] US ex rel. Gill v. CVS Health Corp., et al., No. 1:18-cv-06494 (N.D. Ill. Feb. 25, 2022), ECF 31.
[10] Grant ex rel. US v. Zorn, 107 F.4th 782 (8th Cir. 2024).
[11] 42 USC § 1320a-7b(g) (emphasis added).
[12] United States v. Regeneron Pharms., Inc., No. 23-2086 (1st Cir. filed Dec. 22, 2023).
Record Number of Qui Tam Suits Filed by Whistleblowers in 2024
During the 2024 fiscal year a record 979 qui tam lawsuits were filed by whistleblowers under the False Claims Act and the U.S. government recovered over $2.4 billion in qui tam cases, according to statistics released yesterday by the U.S. Department of Justice (DOJ).
Whistleblowers and the government were party to 558 False Claims Act settlements and judgments in FY 2024, the second highest ever, and total recoveries exceeded $2.9 billion. This means that qui tam whistleblower cases accounted for more than 82% of False Claims Act recoveries during FY 2024.
“Year after year, the DOJ’s False Claims Act statistics reaffirm an undeniable truth: whistleblowing works,” says leading whistleblower attorney Stephen M. Kohn of Kohn, Kohn & Colapinto. “Thanks to their bravery and inside knowledge, whistleblowers recover billions of dollars for taxpayers every year.”
“It is imperative that the DOJ fully supports and empowers whistleblowers,” adds Kohn, who is also Chairman of the Board of National Whistleblower Center (NWC).
Under the False Claims Act, whistleblowers with knowledge of government contracting fraud may file qui tam lawsuits on behalf of the U.S. government. In successful qui tam cases, whistleblowers are eligible to receive between 15 and 30% of the recoveries.
Since the qui tam provisions were modernized in 1986, whistleblowers have allowed the government to recover over $55 billion in taxpayer dollars from fraudsters.
In September, a district court ruled that the False Claims Act’s qui tam provisions are unconstitutional. The U.S. government has urged the U.S. Court of Appeals for the Eleventh Circuit to reverse the district court ruling, noting that “other than the district court here, every court to have addressed the constitutionality of the False Claims Act’s qui tam provisions has upheld them.”
Whistleblower Awarded $1.8 Million for Reporting Hospital Admissions Kickback Scheme
Healthcare professionals play a critical role in ensuring the integrity of the industry. However, unlawful kickbacks and fraudulent claims, if left unreported, undermine the quality of patient care and solvency of government-funded healthcare programs. A recent case involving Oroville Hospital highlights not just the consequences of violating regulations such as the False Claims Act and Anti-Kickback Statute but also the importance of whistleblowers in combatting such schemes.
Oroville Hospital Settlement Details
Oroville Hospital has agreed to pay $10.25 million to resolve allegations of participating in an illegal kickback and self-referral scheme. The settlement is divided, with $9,518,954 going to the federal government and $731,046 to the State of California.
The allegations claim that Oroville Hospital:
Paid Illegal Kickbacks to Physicians – Oroville Hospital allegedly incentivized physicians responsible for inpatient admissions by offering bonuses tied to how many patients they admitted. This practice incentivized unnecessary hospital stays, jeopardizing patient welfare and inflating healthcare costs.
Falsely Billed Medicare and Medi-Cal – The hospital allegedly admitted patients who did not need inpatient care. Furthermore, they also allegedly added false diagnosis codes such as systemic inflammatory response syndrome (SIRS) to claims, inflating reimbursements from Medicare and Medicaid (Medi-Cal in California).
The Vital Role of Whistleblowers in Healthcare Compliance
The Oroville Hospital case underscores the critical importance of whistleblowers in protecting healthcare systems from unlawful practices. The allegations in this case were originally brought forward by a private individual under the qui tam provisions of the False Claims Act.
Under the qui tam provision, whistleblowers can file lawsuits on behalf of the government and potentially receive a portion of any monetary recovery resulting from the case. The whistleblower received approximately $1.8 million or about 17% of the settlement for her role in exposing these unlawful activities.
Why Whistleblowers Are Essential
Whistleblowers are often employees or professionals working within the healthcare system who become aware of illegal or unethical practices. Here is why their role is indispensable:
1. Preventing Patient HarmUnethical behavior, such as unnecessary hospitalizations or improper medical diagnoses, can seriously harm patients. Whistleblowers bring attention to these issues and ensure medical practices prioritize patient health over profit.
2. Protecting Government ResourcesFraudulent claims and improper billing practices drain billions of dollars each year from federal programs such as Medicare, Medicaid, TRICARE, and FEHB. Whistleblowers help uncover these schemes, ensuring that taxpayer funds are used effectively and healthcare remains affordable.
3. Encouraging Transparency and AccountabilityBy exposing unlawful actions, whistleblowers hold organizations accountable and encourage others in the industry to comply with regulations such as the Anti-Kickback Statute and the False Claims Act.
4. Facilitating Internal ImprovementsWhen courts order companies to implement Corporate Integrity Agreements or similar oversight measures as a result of whistleblower actions, healthcare organizations are compelled to implement stronger compliance frameworks, reducing the risk of future violations.
EnforceMintz — Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid supply chain, and two themes dominated the most significant opioid cases and resolutions of 2024. First, two major settlements from the past year highlight examples of allegations that crossed a line, prompting the government to pursue criminal charges. Second, a number of recent cases against pharmacies involve a common theory of liability based on the Controlled Substances Act (CSA), which served as the basis for civil liability under the False Claims Act (FCA).
Opioid-Related Criminal Resolutions
In February 2024, Endo, a pharmaceutical manufacturer that previously filed for bankruptcy, reached a global resolution of various criminal and civil investigations into the company’s sales and marketing of opioid drugs. The company agreed to pay the government $464.9 million over 10 years (though the actual total payment amount will likely be much lower due to bankruptcy).
To resolve the criminal investigation, Endo agreed to plead guilty to a one-count misdemeanor charge for violations of the federal Food, Drug, and Cosmetic Act (FDCA). That charge related to the company’s marketing of the drug’s purported abuse deterrence, tamper-resistant, or crush-resistant properties to prescribers, despite a lack of supporting clinical data. In the plea agreement, the company admitted responsibility for misbranding its opioid drug by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the FDCA.
More recently, in December 2024, McKinsey & Company, a worldwide management consulting firm, agreed to pay $650 million to resolve criminal and civil investigations related to the firm’s consulting work for Purdue Pharma, the maker of OxyContin. As noted in the government’s press release, the McKinsey resolution was the first time a management consulting firm has been held criminally responsible for its advice resulting in a client’s criminal conduct.
The two-count criminal charging document accused McKinsey of conspiring to misbrand a controlled substance and obstruction of justice. The conspiracy charge related to McKinsey’s work to “turbocharge” OxyContin sales by targeting high-volume opioid prescribers. The obstruction charge arose from the alleged deletion by a senior partner of certain documents related to the company’s work for Purdue. To resolve those charges, McKinsey entered into a five-year deferred prosecution agreement (DPA). Under the DPA, McKinsey agreed not to do any consulting work related to the marketing, sale, or distribution of controlled substances and agreed to implement significant changes to its compliance program. Separately, the former McKinsey senior partner who allegedly destroyed records relating to the company’s work for Purdue was charged with obstruction of justice and agreed to plead guilty to that charge.
These two resolutions are relevant to all entities in the opioid supply chain, from manufacturers to consultants and all stakeholders in between. Sales and marketing practices, or abuse deterrence claims or practices targeting prescribers based on volume, can lead to both civil liability and potential criminal exposure.
Pharmacies Face Potential FCA Liability Based on CSA Violations
On the civil side, three opioid enforcement actions were particularly noteworthy. Three years ago, we highlighted some of the first pharmacy-related resolutions, which showed that pharmacies were “next in line” for opioid related enforcement. In 2024, two substantial settlements involved alleged CSA violations giving rise to FCA liability. A third FCA lawsuit filed in December 2024 against the nation’s largest pharmacy shows that this trend will likely continue in 2025 and beyond.
In July 2024, Rite Aid and its affiliates agreed to settle allegations brought by the government related to its opioid dispensing practices. Rite Aid had previously filed for bankruptcy, so the settlement agreement involved a payment of $7.5 million, plus a general unsecured claim of $401.8 million in the bankruptcy case.
The government alleged that Rite Aid pharmacists dispensed unlawful prescriptions and failed to investigate “red flags” before dispensing opioid prescriptions, then improperly submitted claims to the government for reimbursement of those prescriptions. The government alleged that the company dispensed unlawful prescriptions by (1) filling so-called “trinity” prescriptions, which are a combination of opioid, benzodiazepine, and muscle relaxants; (2) filling excessive quantities of opioid prescriptions; and (3) filling prescriptions written by prescribers previously identified as suspicious by pharmacists.
Similarly, in December 2024, Food City, a regional grocery store and pharmacy based in Virginia agreed to pay $8.48 million to resolve allegations that it dispensed opioids and other controlled substances in violation of the CSA and the FCA. Like the Rite Aid case, the government alleged that these prescriptions were medically unnecessary, lacked a legitimate medical purpose, or were not dispensed pursuant to valid prescriptions. The government alleged that Food City ignored “red flags” including, among other things, (1) prescribers who wrote unusually large opioid prescriptions; (2) early refills of opioids; (3) prescriptions for unusual quantities or combinations of opioids; and (4) patients who were filling prescriptions for someone else, driving long distances to fill prescriptions, or paying cash for prescriptions.
Also in December 2024, the Department of Justice announced that it had intervened in a nationwide lawsuit alleging that CVS Pharmacy filled unlawful prescriptions in violation of the CSA and sought reimbursement for those prescriptions in violation of the FCA. The lawsuit is currently pending. The theory of liability asserted against CVS is similar to the Rite Aid and Food City cases: CVS allegedly filled unlawful prescriptions, ignored “red flags” of abuse and diversion, and sought reimbursement from federal health care programs for unlawful prescriptions in violation of the FCA.
Under the CSA and applicable regulations, pharmacists dispensing controlled substances, like opioids, have a “corresponding responsibility” to ensure that the prescription was issued for a legitimate medical purpose. 21 C.F.R. § 1306.04(a). Exercising that corresponding responsibility requires identifying and resolving “red flags” before filling a prescription. There is no defined list of what the government deems to constitute “red flags” and determining the existence of red flags is often context dependent. Because FCA lawsuits based on alleged CSA violations appear to be a growing trend, these three cases provide helpful guidance for companies seeking to mitigate risk by implementing corporate compliance programs designed to identify and resolve “red flags” related to opioid prescriptions.
EnforceMintz — Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come
In last year’s edition of EnforceMintz, we predicted that 2024 would bring an increase in False Claims Act (FCA) enforcement activity related to COVID-19 pandemic fraud. Those predictions proved correct. The COVID-19 Fraud Enforcement Task Force (CFETF), in conjunction with five COVID Fraud Enforcement Strike Forces and other government agencies, has resolved many significant criminal and civil pandemic fraud cases over the past year. In April 2024, the CFETF released a COVID-19 Fraud Enforcement Task Force 2024 Report (the CFETF Report) describing the CFETF’s recent efforts and including a plea for more fraud enforcement funding, which suggests that additional enforcement activity is on the horizon. While that funding request has thus far gone unheeded, we expect more civil pandemic fraud enforcement actions (and continuing criminal actions) in 2025.
Civil and Criminal Paycheck Protection Program (PPP) Fraud Enforcement
Since 2020, criminal PPP fraud has dominated COVID-19 fraud enforcement headlines, and 2024 was no different. Criminal fraud schemes have concerned common fact patterns involving fraudsters who (i) obtained funding to which they were not entitled, (ii) submitted false certifications or inaccurate information in a loan application, or (iii) submitted false certifications or inaccurate information in seeking loan forgiveness. However, in the past year, civil PPP fraud enforcement has begun to evolve.
In 2024, criminal PPP fraud enforcement broke up multiple COVID-19 fraud rings involving actors who fraudulently obtained loans for fictitious businesses, packed PPP applications with false documentation (provided in exchange for kickbacks), and falsely certified information regarding the number of employees and payroll expenses that would entitle them to PPP funding. Typical charges in these cases included wire fraud, bank fraud, making false statements to federally insured financial institutions, conspiracy, and money laundering.
On the civil side, PPP fraud enforcement seemed to increase in 2024. Interestingly, some civil PPP fraud cases involved schemes similar to criminal actions. Often the government’s decision to pursue such cases as civil, criminal, or both depends on the evidence of intentional fraud. For example, in January 2024, a clinic and its owners agreed to a $2 million judgment in connection with multiple fraudulent acts, including PPP fraud arising from their certification that they were not engaged in illegal activity and that their business suffered quarterly or year-over-year losses, therefore entitling them to PPP funding. In October 2024, one FCA recovery totaling $399,990 involved a home health agency and its owner who received two PPP loans after certifying that the company would receive only one. More recently, in December 2024, a private asset management company and its owner agreed to pay $680,000 to settle FCA allegations brought by a relator. The company and its owner allegedly falsely certified that PPP loans were economically necessary and included false statements in the information submitted when seeking forgiveness for the loan. Cases of this nature apparently did not rise to the level of criminal wrongdoing, in the government’s view.
A number of civil PPP fraud FCA cases from the past year involved increasingly complex theories and allegations. These more complicated fact patterns require years of investigation and are expensive. As a result, such fraud enforcement actions may have a “long tail” and continue for years to come.
For example, in May 2024, a private lender of PPP loans agreed to resolve allegations that it knowingly awarded inflated and fraudulent loans to maximize its profits, then sold its assets and bankrupted the company. The lawsuit was initiated by whistleblowers (known under the FCA as “relators”), including an accountant and former analyst in the lender’s collection department. As part of the settlement with the lender, the United States received a general unsecured claim in the bankruptcy proceeding of up to $120 million.
More recently, in December 2024, the United States intervened in a complaint against certain former executives of the lender who allegedly violated the FCA by submitting and causing the submission of false claims for loan forgiveness, loan guarantees, and processing fees to the Small Business Administration (SBA) in connection with lender’s participation in the PPP. When we discussed this case previously, we noted that we expected to see similar cases in the future brought against private lenders who failed to safeguard government funds. More broadly, we expect the trend of increasingly complex civil PPP fraud actions will continue in 2025.
Fraud Enforcement Involving Programs Administrated by the Health Resources and Services Administration (HRSA)
Provider Relief Fund (PRF) and Uninsured Program (UIP) fraud enforcement picked up in 2024. As described in the CFETF Report, the CFETF has leveraged an interagency network to make strategic improvements in how it investigates fraud. (Interagency collaboration is another theme from 2024, which we discuss more here.) The CFETF Report also describes a department-wide effort by the Department of Justice (DOJ) to roll out database tools to all US Attorney’s Offices to detect and investigate fraud. According to the CFETF Report, DOJ has analyzed more than 225 million claims paid by HRSA, the entity that dispensed PRF and UIP loans during the height of the pandemic. Closer investigatory scrutiny has led to increased enforcement actions.
PRF Fraud
Criminal PRF fraud enforcement resembled PPP enforcement from prior years, which was often based on theft or misappropriation theories. These enforcement actions often include charges against PRF recipients who either (i) retained funds to which they were not entitled or (ii) used PRF funds for ineligible expenses, like luxury goods. For example, in April 2024, a defendant who operated a primary care clinic pleaded guilty to theft and misappropriation of PRF funds. The defendant had certified that PRF funds would be used by the clinic only to prevent, prepare for, and respond to COVID-19. Despite making this representation, the clinic operator used the PRF funds for personal purposes, including cash withdrawals and the purchase of personal real estate, a luxury vehicle, a boat, and a trailer.
UIP Fraud
There were a number of noteworthy criminal UIP enforcement actions in 2024. In March 2024, a defendant was charged with filing fraudulent COVID-19 testing reimbursement, through the laboratory he managed, for COVID-19 testing that was never provided. The defendant allegedly obtained and used the personal identifying information of incarcerated or deceased individuals in connection with those claims. The indictment alleged that the defendant received $5.6 million in reimbursement and used those UIP funds to purchase property in South Florida.
Enforcement actions involving UIP funds involved significant alleged losses by the government. In February 2024, a defendant pleaded guilty to mail fraud and identity theft charges in what the government called “one of the largest COVID fraud schemes ever prosecuted.” The defendant and her co-conspirators filed more than 5,000 fraudulent COVID-19 unemployment insurance claims using stolen identities to unlawfully obtain more than $30 million in UIP fund benefits. To execute the scheme, the defendant and others created fake employers and employee lists using the personally identifiable information of identity theft victims. The defendant was sentenced to 12 years in prison, and seven co-conspirators have also pleaded guilty in connection with this large fraudulent scheme.
In one major civil FCA resolution, in June 2024, a group of affiliated urgent care providers agreed to pay $12 million to resolve allegations that they submitted or caused the submission of false claims for COVID-19 testing to the HRSA UIP. The government alleged that the providers knew their patients were insured at the time of testing (and in some instances had insurance cards on file for certain patients), yet they submitted claims (and caused laboratories to submit claims) to HRSA’s UIP for reimbursement. The resolution is noteworthy because the providers received a relatively low FCA damages multiplier as credit for cooperating with the government in its investigation under DOJ’s Guidelines for Taking Disclosure, Cooperation, and Remediation into Account in False Claims Act Matters. More information on DOJ’s efforts to encourage voluntary self-disclosure can be found in our related EnforceMintz article here.
Fraud Schemes Involving Respiratory Pathogen Panels
Fraud involving expensive respiratory pathogen panels (RPPs) has been in the spotlight since the beginning of the pandemic. In 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) warned about laboratories with questionably high billing for tests submitted for reimbursement alongside COVID-19 tests, including RPPs. The OIG deemed this scenario as deserving of “further scrutiny.” Medicare reimbursed some outlier laboratories approximately $666 dollars for COVID-19 testing paired with other add-on tests while Medicare reimbursed approximately $89 for this same testing to the majority of laboratories. The trend in RPP fraud enforcement that we discussed last year continued in 2024: enforcement actions involved a mix of criminal and civil RPP fraud cases involving significant damages.
One laboratory owner was criminally charged with submitting $79 million in fraudulent claims to Medicare and Texas Medicaid for medically unnecessary RPP tests. The laboratory owner used the personal information of a physician — without the physician’s knowledge — to submit the claims even though the physician had no prior relationship with the test recipients, was not treating the recipients, and did not use the test results to treat the recipients. The government seized over $15 million in cash from this defendant.
In another case involving both criminal and civil charges, a Georgia-based laboratory and its owner agreed to pay $14.3 million to resolve claims that they paid independent contractor sales representatives volume-based commissions to recommend RPP testing to senior communities interested only in COVID-19 testing. The independent sales contractors used forged physician signatures and sham diagnosis codes to add RPP testing to requisition forms ordering only COVID-19 testing. The whistleblower in this case — the laboratory’s manager — is set to receive $2.86 million of the recovery.
As the government continues to deploy data analytics to identify outlier cases, we suspect enforcement actions involving COVID-19 companion testing will continue.
Future of COVID-19 Enforcement
Over four years from the enactment of the CARES Act, COVID-19 fraud enforcement continues to evolve. Since the beginning, the government has consistently pursued criminal cases involving misused or fraudulently obtained funds, fake COVID cures, and fake COVID testing. In 2022, the government extended the statute of limitations for PPP fraud from five to ten years, recognizing that more time was needed to investigate and prosecute fraud on these programs.
This past year, a broader range of pandemic fraud schemes were prosecuted criminally and civilly. These often data-heavy or analytics-based cases require a significant investment of time and resources. Recognizing the resources required for these more complicated matters, the CFETF called for increased funding and an extension of the statute of limitations for all pandemic-related fraud in the CFETF Report. As of the date of this publication, that request has not yet been answered. It thus appears the funding request will be determined by the new administration.
Despite uncertainty around future funding for COVID-19 fraud enforcement, we anticipate more criminal and high-dollar civil enforcement actions in 2025. The CFETF Report described 1,200 civil pandemic fraud matters pending as of April 1, 2024, for which DOJ had obtained more than 400 judgments or settlements totaling over $100 million. This leaves approximately 800 pending civil matters, and untold billions in fraudulently obtained funds still in the hands of fraudsters. Despite uncertainty around future fraud enforcement funding, as a general matter, fraud enforcement has bipartisan support. Either way, employees, related parties, and patient relators — with the support of sophisticated relator’s counsel — will likely continue to bring pandemic fraud cases in the coming years. Overall, COVID-19 fraud enforcement is unlikely to slow down in 2025.
EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025
As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D False Claims Act settlement. Year over year, as the number of enrollees in Medicare Advantage plans and Part D plans has steadily increased, the total federal spending on Medicare Advantage and Part D has likewise risen and the spotlight on these programs and those who participate in them has intensified.
As seen in years past, the Department of Justice (DOJ) as well as the two agencies that regulate Medicare Advantage Organizations (MAOs) and Part D plan sponsors (PDP Sponsors), the Centers for Medicare & Medicaid Services (CMS), and the Office of Inspector General for the Department of Health and Human Services (OIG), focused much of their attention on risk adjustment activities. DOJ remained in active litigation against many of the largest MAOs in the country while CMS and the OIG began conducting risk adjustment audits subject to extrapolation. Throughout 2024, the industry challenged CMS’s regulatory actions relating to Star Ratings and rules for communicating with Medicare beneficiaries who are considering Medicare Advantage and Part D plans. Finally, On December 9, 2024, CMS also finalized its updated Overpayment Rule for MAOs and PDP Sponsors in the 2025 Physician Fee Schedule Rule.
With Medicare Advantage expected to remain a top enforcement priority in 2025 and Part D enforcement growing, we anticipate that DOJ and CMS will continue to target the actions not only MAOs and PDP Sponsors, but also vendors and third-party entities that touch the Part C and D programs. In 2025, we will also be closely watching for court decisions in ongoing litigation matters that will undoubtedly influence future theories of liability and test the strength of defenses raised by MAOs, PDP Sponsors, and their vendors.
Recent Settlements Demonstrate that DOJ’s Enforcement Interest Spans the Industry
In 2024, DOJ settled two notable False Claims Act (FCA) matters relating to Medicare Advantage, which demonstrate that DOJ’s enforcement interests are not limited to MAOs, but also include vendors and other third-party entities engaged in risk adjustment practices and more. Plus, DOJ settled a large Part D matter relating to how drug costs are reported to and impact Medicare Part D payments from CMS.
Last year, Principal Deputy Assistant Attorney General Brian M. Boynton underscored DOJ’s “commitment to holding accountable third parties that cause the submission of false claims” and the government’s intention to “expand its focus on the Medicare Part C Program to include an examination of the role that vendors and providers play in the diagnoses that are submitted to the government.” DOJ made good on this promise.
For example, DOJ targeted entities involved in marketing efforts to Medicare Advantage patients. In September, Oak Street Health (Oak Street) agreed to pay $60 million to resolve the government’s allegations that it paid kickbacks to third-party insurance agents in exchange for recruiting Medicare beneficiaries to Oak Street’s primary care clinics in violation of the FCA. More specifically, DOJ alleged that Oak Street violated the Anti-Kickback Statute when, in exchange for referring Medicare beneficiaries to Oak Street, Oak Street paid insurance agents (who were acting as agents for MAOs) $200 per beneficiary referred or recommended to Oak Street’s primary care clinics. DOJ further alleged that the insurance agents delivered targeted messages to eligible seniors designed to generate interest in Oak Street and that the payments received incentivized those agents to base their referrals and recommendations on the financial motivations of Oak Street rather than the best interests of seniors. The complaint was filed by a relator who partnered with insurance agents and was contacted by Oak Street, and DOJ intervened in September for purposes of settlement. Although this settlement was with a provider organization (as explained further in), the conduct focused on Medicare Advantage members and their interactions with agents and brokers. CMS similarly highlighted its concerns regarding misleading communications to Medicare beneficiaries in its updated Medicare Advantage and Part D communication rules discussed below.
DOJ also reached a settlement agreement with a risk adjustment coding vendor this December. DOJ kicked off the holiday season by announcing the long-awaited settlement with MAO Independent Health Association, its wholly owned subsidiary and risk adjustment vendor DxID, and DxID’s former CEO, totaling up to $100 million across the three defendants. The government alleged that DxID improperly coded diagnoses from member medical records to inflate Medicare’s payments to Independent Health, including by coding from improper sources, coding conditions for which patients were not treated, and sending addenda to providers months or years after the service occurred. The parties have seemingly been engaged in settlement discussions for years, jointly requesting continual extensions of time for defendants to answer DOJ’s complaint since 2023.
Under this settlement structured based on Independent Health’s ability to pay, Independent Health will make guaranteed payments of $34.5 million and contingent payments of up to $63.5 million on behalf of itself and DxID, which ceased operations in 2021. DxID’s CEO, Betsy Gaffney, will independently pay $2 million. While Independent Health did not admit fault under the settlement agreement, the MAO also entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG requiring that Independent Health hire an Independent Review Organization to annually review a sample of its Medicare Advantage beneficiary medical records and its internal controls to help ensure appropriate risk adjustment payments.
Additionally, following years of CMS voicing concerns over Part D Direct and Indirect Remuneration (DIR) and beneficiary protections, DOJ for the first time settled a significant matter relating to Part D DIR reporting. In July, DOJ entered into a settlement agreement with Elixir Insurance Company (Part D plan sponsor), Rite Aid Corporation (Parent Organization), and Elixir Rx Solutions (PBM) for a total of $121 million to resolve allegations that the defendants failed to appropriately report drug rebates through the Medicare Part D DIR reporting mechanism that is used by CMS to reconcile and calculate payments to Part D plan sponsors. Because Rite Aid Corporation, the parent organization, had declared bankruptcy, a portion of the settlement ($20 million) was granted as an allowed, unsubordinated, general unsecured claim in Rite Aid’s bankruptcy case in the District of New Jersey.
This is the first substantial Part D settlement focusing on Part D DIR, and it aligns with a theory of liability that DOJ has been considering for almost a decade. DOJ alleged that amounts that should have been reported as DIR (and therefore would have reduced the amount of revenue the government would pay a PDP Sponsor) were instead falsely reported as fees that do not qualify as DIR, and therefore the PDP Sponsor received and retained government payments to which it was not entitled.
Ongoing Litigation is Likely to Shape Risk Adjustment Enforcement in 2025 and Beyond
As previewed in last year’s report, DOJ continued to litigate three large FCA risk adjustment-focused cases last year against United Healthcare, Kaiser Foundation Health Plans and their affiliated medical groups, and Anthem. Because DOJ’s regulatory expectations of MAOs are often borne out through enforcement actions, judicial instruction on this topic is likely to shape future government actions and exemplify the standard of due diligence MAOs are expected to uphold when engaging in risk adjustment coding activities.
We summarized the current status and next steps for these three key cases below:
UnitedHealthcare. Litigation continued last year between the country’s largest MAO and DOJ in US ex rel. Poehling v. UnitedHealth Group, Inc. et al. (C.D. Cal.), reaching a key milestone this summer when the parties filed cross motions for summary judgment. In its Complaint in Intervention filed back in 2017, DOJ alleged that United failed to delete inaccurate diagnosis codes that it knew were unsupported by the medical records and thus resulted in overpayments. As one of the few Medicare Advantage lawsuits to reach this stage of litigation, we are watching closely for a summary judgment decision in the new year focused on the elements required to prove liability under the FCA’s reverse false claims provision.
Anthem. The government raised similar allegations against Anthem in United States v. Anthem, Inc. (S.D.N.Y), arguing that Anthem failed to identify and remove inaccurate diagnosis codes as part of its chart review program. DOJ and Anthem spent 2024 litigating discovery disputes and are set to remain in discovery through 2026.
Kaiser. DOJ also remained in active discovery with Kaiser in the lawsuit US ex rel. Osinek v. Kaiser Permanente (N.D. Cal.). The government’s Complaint in Intervention, filed in 2021, focuses on Kaiser’s use of addenda in medical records. DOJ alleges that Kaiser pressured physicians to create addenda often months after the patient encounter to retroactively add unsupported diagnoses, and that Kaiser used “data mining” programs to identify missed diagnoses and create the addenda. Following the denial of Kaiser’s motion to dismiss, the parties spent 2024 litigating discovery disputes before a magistrate judge. The case will remain in the discovery phase at least through 2025, with dispositive motions not scheduled until 2026, and a trial date currently set over two years out in 2027.
CMS and The OIG Take Active Role in Regulating Medicare Advantage and Part D with New Rules and the Impact of Extrapolation
Similar to DOJ’s expanded enforcement approach discussed above, both CMS and the OIG continued to focus on risk adjustment activities while CMS also began more heavily regulating agents and brokers who communicate with Medicare beneficiaries.
Risk Adjustment, RADV Audits, and Overpayment Rule: As it relates to risk adjustment, the OIG issued a second report concerning MAOs’ alleged use of in-home health risk assessments (IH-HRAs) to drive up payments. IH-HRAs are exams conducted by health care providers (typically nurse practitioners) in a member’s home to collect information regarding that patient’s health. In its report, the OIG identified 20 MAOs that it believes are outliers for their use of IH-HRAs as a tool to report diagnoses of their members to CMS. The OIG published a similar report in 2021 concluding that IH-HRAs and chart reviews are vulnerable to misuse by MAOs, which has likely driven DOJ enforcement action targeting these practices since.
CMS and the OIG regularly conduct audits of the diagnosis codes that MAOs submitted for their members. Critically, in 2024, the OIG finalized and CMS initiated risk adjustment audits that reached Payment Year (PY) 2018, which is the first year that extrapolation under the CMS final rule applies. Under this rule (42 C.F.R. 422.310(e)) which was finalized in February 2023, CMS has the authority to extrapolate risk adjustment audit findings covering diagnosis codes MAOs submitted in PY 2018 and forward. For years prior to PY 2018, MAOs have only had to repay overpayments identified in the actual sample that CMS or the OIG reviewed.
Last year CMS selected the MAOs that will be subject to PY 2018 Risk Adjustment Data Validation (RADV) Audits and has initiated that process with the selected MAOs. The OIG has already completed certain audits that include PY 2018 and the monetary impact of extrapolation of the findings is immediately apparent. For example, Humana’s final report for diagnosis-targeted audits imposed an overpayment obligation of just $274,000 for diagnoses audited from PY 2017 (no extrapolation) as compared to over $6.5 million in estimated overpayments for diagnosis codes audited from PY 2018 (with extrapolation). Similarly, Health Assurance of Pennsylvania’s final report auditing diagnosis codes in PYs 2018 and 2019 with extrapolation totaled $4.2 million in overpayments.
Additionally, in early December, CMS finalized the Overpayment Rule that requires MAOs and Part D plan sponsors to report and return overpayments within 60 days of an identification. The Rule was initially adopted in 2014 and held MAOs and Part D plan sponsors to a “reasonable diligence” standard when determining when an overpayment had been “identified.” The “reasonable diligence” standard was struck down in United Healthcare Insurance Company v. Azar when the district court held that the standard was impermissibly being used to establish False Claims Act liability. The updated Overpayment Rule, proposed in December 2022, has now replaced the “reasonable diligence” standard with the knowledge standard from the False Claims Act. An MAO is now considered to have “identified” an overpayment when it knowingly (either with actual knowledge, or through reckless disregard or deliberate ignorance) receives or retains an overpayment.
Medicare Advantage and Part D Communication Rules: CMS adopted changes to the Medicare Advantage and Part D Communication regulations for 2025 that, according to CMS, seek to increase transparency and protect Medicare beneficiaries from receiving misleading information about coverage options. CMS expressed concern that agents and brokers who were contracted with MAOs and Part D plan sponsors were enrolling beneficiaries into plans based on which plans paid the agents and brokers the most money, rather than the plan that was in each beneficiary’s best interests.
To address this concern, the revised regulations: (1) prohibit MAOs and Part D plan sponsors from having contract provisions that could directly or indirectly create an incentive that would reasonably be expected to inhibit an agent or broker’s ability to objectively assess and recommend which plan best fits the health care needs of the beneficiary, (2) recognize that MAOs and Part D plan sponsors may pay agents and brokers and Third-Party Marketing Organizations (TPMOs) for certain administrative and overhead expenses but limit the payment for such services to $100 per member enrolled by the agent, broker, or TPMO, previously there was no express limit other than that the values of such payments must not exceed those within the market), and (3) adopt more stringent consent requirements needed in order for a beneficiary’s information to be shared by a TPMO with a third party, including related third parties. As described further below, many entities that provide agent and broker services, referred to as field marketing organizations, or FMOs, sued CMS over these rule changes.
Following these regulatory changes and DOJ actions against brokers and agents, the OIG also weighed in when in December it issued a Special Fraud Alert warning the industry regarding its perceived risks of marketing arrangements between MAOs and health care providers or between providers and agents and brokers for MAOs. We discuss this alert further in our article here.
Industry Actions are on the Rise following the Demise of Chevron Deference
As has been widely reported, the US Supreme Court issued in June a landmark decision in Loper Bright Enterprises v. Raimondo, which struck down the longstanding doctrine of so-called “Chevron deference” to federal agency interpretation of ambiguous statutes and substantially expanded judicial review of such statutes. As expected, Loper Bright has already led to increased scrutiny of, and challenges to, agency action, including in the Medicare space. While “enforcement” against agencies is not typical government “enforcement,” it affects government enforcement matters because it impacts how agencies can take enforcement actions and what rules are enforceable.
In May 2024, certain FMOs sued CMS in the United States District Court for the Northern District of Texas, seeking to invalidate certain portions of the 2025 Medicare Advantage and Part D Communications regulations. The FMOs argued that the provision of these rules, summarized above in the Medicare Advantage and Part D Communication Rules section, violated the Administrative Procedure Act (APA). They argued that the rule was arbitrary and capricious under the APA, claiming that CMS finalized the rule based on “pure speculation,” ignored objections from the public, and failed to acknowledge reliance interests of brokers. The FMOs further contended that the rule failed to properly adhere to the notice and comment procedural requirements because CMS relied upon evidence not presented during notice and comment rulemaking. Less than a week after the Loper Bright decision, the court granted the FMOs’ request for a preliminary injunction relating to the regulation that restricted contract terms and limited administrative fee payments, finding that the rules were not reasonable.
Also, last fall four of the largest MAOs, UnitedHealthcare, Centene, Elevance, and Humana, all challenged how CMS calculated their specific Star Ratings, and, more recently, at least two Blues plans have also sued CMS. Star Ratings is the system that CMS uses to rate the performance of MAO and PDP plan sponsors. A plan’s Star Rating impacts how and when it can be marketed, and in Medicare Advantage, impacts how the plan is paid and when CMS can terminate a plan’s contract. United and Centene’s cases were relatively similar, focusing on how CMS evaluated and calculated a certain call center measure. Humana and Elevance each had arguments specific to their circumstances, and also included broader complaints regarding how CMS calculates Stars. Humana specifically challenged CMS’s unwillingness to share industry data with MAOs to ensure appropriate calculations. On November 22, 2024, the Eastern District of Texas granted summary judgment for UnitedHealthcare and ordered CMS to recalculate the MAO’s Star Rating by removing the one call center measure in dispute. In early December, Centene reported that CMS recalculated its Star Rating for 2025 following its challenge. The other cases are ongoing.
The challenges to Star Ratings are an important enforcement development because these lawsuits may force CMS to rethink how it operates the Star Ratings program and may impact whether CMS can terminate contracts that CMS believes are low performing.
Conclusion
Following another year of intense scrutiny, the Medicare Advantage industry is set to remain a government enforcement priority in 2025, and PDP plan sponsors will likely attract similar scrutiny. Both MAOs as well as third-party entities involved in the Part C program should continue to monitor DOJ enforcement activity and decisions in ongoing litigation to evaluate their risk adjustment practices. Moreover, with the danger of extrapolation of risk adjustment audits evident, MAOs must be mindful to engage in robust compliance efforts and to review published OIG reports and related guidance to mitigate enforcement risk. PDP Sponsors and their vendors should expect increased scrutiny following the Elixir settlement, the continued rollout of the Inflation Reduction Act and the intense national discussion regarding prescription drug costs. We will continue to monitor the evolving enforcement actions against MAOs and PDP Sponsors and watch closely for updated guidance whether via agency regulations and reports or court decisions in 2025 and beyond.