On May 8, 2025, the Boston Bar Association hosted its annual White Collar Crime Conference, a reoccurring theme of which was the recognition of changing times, while also maintaining that the core principles of criminal and civil fraud enforcement remain the same. An anticipated highlight from the conference came from the panel addressing federal and state False Claims Act (FCA) and Anti-Kickback Statute (AKS) enforcement priorities.
The conference featured judges from the US District Court for the District of Massachusetts, prosecutors from the US Attorney’s Office for the District of Massachusetts (the Office) and the Office of the Massachusetts Attorney General (the AG’s Office), and lawyers from the whistleblower and defense bars. Panelists included key leaders from the Office’s Civil Enforcement Unit, Healthcare Fraud Unit, and Securities, Financial, and Cyber Fraud Unit and from the AG’s Office, Medicaid Fraud Division.
Same Difference, According to the FCA/AKS Panel
The FCA/AKS panel kicked off with a robust discussion of enforcement priorities and the impact of certain major FCA/AKS case decisions. Kickbacks involving broker arrangements and private equity investments in healthcare are likely to be areas of focus. Several panelists foreshadowed potential future logistical problems resulting from staffing shortages. The panelists also expect an increase in certain nonhealthcare-related FCA cases (e.g., Paycheck Protection Program (PPP) loans, cyberfraud), but the Office emphasized continued commitment to investigating fraud in the life sciences and healthcare industries.
Enforcement Priorities
Assistant US Attorney Abraham George, the Chief of the Office’s Civil Division, observed that the Office has a longstanding skillset and interest in healthcare fraud enforcement, which still makes up the bulk of the Office’s focus. Mr. George commented that the Office’s Affirmative Civil Enforcement Unit is fully staffed and FCA enforcement is still going strong, which he expects will continue. In fact, the Office collected $20 million in the first few months of 2025.
Mr. George also reported that the administration backs the FCA, including the constitutionality of the qui tam provision, and will continue to support FCA enforcement, citing as evidence a recent case against three major Medicare Advantage plans.
The original complaint in the case, United States et al. v. eHealth, Inc. et al., Case No. 1:21-cv-11777, which was filed by a whistleblower in 2021 and unsealed on May 1 by the US District Court for the District of Massachusetts, alleges that broker agents sold Medicare Advantage plans between 2016 and 2021 that involved kickbacks from the plans and resulted in patient steering, while the agents simultaneously blocked the sale of other insurance plans that did not pay. Mr. George noted that the Office could not have moved forward with filing a complaint in intervention in a case of this magnitude without the approval of the US Department of Justice, which intervened in the matter along with the Office.
Gregg Shapiro, a panelist from the whistleblower bar and recent Office alumnus, indicated an industrywide practice to engage in improper broker arrangements and forecasted future cases against other plans and brokers. Mr. Shapiro also observed that the administration’s recent executive orders and memoranda regarding DEI and gender affirming care that encourage FCA whistleblowers to come forward are further evidence of the administration’s support of the FCA.
Assistant US Attorney Kelly Begg Lawrence, Chief of the Office’s Healthcare Fraud Unit, characterized as “good news” the fact that there was “no news” in the healthcare space and confirmed that the directives and the Office’s priorities are essentially the same. She indicated that the Office’s mission had not changed and that, in addition to protecting patients, its focus on reducing fraud, waste, and abuse in healthcare is in clear alignment with the administration’s priorities.
At the state level, Kevin Lownds, Deputy Chief of the Medicaid Fraud Division of the AG’s Office, described a good working relationship with the federal government that he did not anticipate would change. He said that, as it has in the past, the AG’s Office will collaborate with the United States when appropriate and make independent decisions when appropriate. Mr. Lownds cited as examples a recent upcoding risk adjustment case filed against certain nursing homes by both the Office and the AG’s Office and another case filed by the AG’s Office, without DOJ intervention, against a retail pharmacy chain for failure to comply with Massachusetts Medicaid prescription drug pricing regulations.
As far as new developments, Ms. Lawrence noted an enforcement trend related to “incautious” investments by private equity firms in healthcare. Mr. Lownds similarly observed that Massachusetts recently amended the Commonwealth’s FCA to focus specifically on private equity and corporate ownership in healthcare and impose FCA liability on investors. Mr. George stated that there has been a recent flood of PPP cases and matters involving cybersecurity fraud. Finally, the defense bar noted an uptick in cases related to customs and trade, artificial intelligence, and pharmaceutical data sharing.
Recent FCA/AKS Cases
Beyond the discussion about the current enforcement environment under the US administration, the FCA/AKS panel focused on the impact of two major FCA/AKS cases, United States v. Regeneron Pharmaceuticals Inc. and United States ex rel. Zafirov v. Florida Medical Associates, LLC. The Office indicated that neither decision would significantly impact cases it will bring under the FCA, while the defense bar insisted that the decisions should result in higher standards on the government to show that the underlying conduct “matters” from a materiality standpoint.
In United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 WL 520466 (1st Cir. Feb. 18, 2025), the US Court of Appeals for the First Circuit held that when the government seeks to establish FCA liability under the 2010 amendments to the AKS, it must show the kickbacks were the “but-for” cause of claims submitted to federal healthcare programs (see our February 2025 Lawflash).
Mr. George, who represented the United States in the Regeneron case, reflected that he did not consider the decision to be as much of a boon for the defense bar as it was portrayed to be in public commentary, in part because “but-for” causation can be established by circumstantial evidence. Mr. Shapiro agreed that but-for causation is not insurmountable and the courts do not expect proof for each fraudulent claim. He also stated, however, that he may take a step back from cases where “all you have is a tainted claim theory.”
Mr. George also reminded attendees that the decision affirmed the false certification theory of liability, which does not require but-for causation between kickbacks and claims and, in his view, is not difficult to prove. Rather than pulling back as a result of the Regeneron case, the Office will prosecute cases in the same manner it did prior to the 2010 amendment by proving false certification and materiality; prosecutors will simply call a witness from CMS to testify.
Finally, the AG’s Office emphasized that Regeneron does not apply to the state AKS because Massachusetts never adopted a state analog to the federal 2010 amendment, and Mr. Lownds commented that the AG’s Office has always brought false certification cases. The defense bar nevertheless maintained that the decision was a victory that would affect the “framework for discussion” in FCA cases where, under either a certification or causation theory of liability, the “message is that it has to matter.”
In United States ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, Case No. 8:19-cv-01236 (M.D. Fla. Sept. 30, 2024), US District Court Judge Kathryn Kimball Mizelle of the Middle District of Florida held that the qui tam provisions of the FCA create self-appointed “officers” of the United States in violation of the Appointments Clause of Article II of the Constitution (see our October 2024 Lawflash). The Zafirov case is pending in the Eleventh Circuit, and the constitutional question remains open.
The FCA panel debated whether interest was waning from the US Supreme Court to take up the issue of the constitutionality of the FCA qui tam provision. The defense bar expressed that whistleblowers have too much power because, even when the government decides not to intervene, it does not adequately use its authority to dismiss frivolous cases. The whistleblower bar unsurprisingly disagreed. Mr. George confirmed that he has never dismissed a case, although he later regretted that decision with respect to a couple of decisions. Mr. Lownds added that a state court would not overturn the state FCA based on the state constitution: “That’s not going to happen.”
Key Takeaways
Despite discussion around Office staffing shortages due to departures and the government’s current hiring freeze, US Attorney Leah B. Foley pledged in her fireside chat at the conference’s close that the Office will continue to lead in healthcare fraud and collaborate with other US Attorney’s Offices and the DOJ. She also confirmed that she does not anticipate any changes with respect to the Office’s interactions with whistleblowers; the Office will continue to be open to all whistleblower cases.
Despite what many acknowledged as atypical times, panelists throughout the conference maintained that law enforcement priorities for the life sciences and healthcare industries had not changed. Medicare Advantage plans in particular should be prepared to respond to inquiries from the Office related to broker agreements and risk adjustment. Similarly, private equity firms should ensure robust diligence around investments in the healthcare sector and carefully monitor the ongoing operations of any acquisitions. Finally, plans and providers can expect that whistleblower complaints will continue in full force and are unlikely to be declared unconstitutional.
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