DAAG Brenna Jenny Warns Heightened FCA Enforcement Is “The New Normal,” Addresses Enforcement Priorities and Policies

During her keynote speech at the Federal Bar Association’s Qui Tam Conference, Brenna Jenny,  Deputy Assistant Attorney General for the Commercial Litigation Branch, stated that robust FCA enforcement is “the new normal.” Key statistics, including those we discussed here, back her up: she revealed that DOJ has issued more than 1,000 Civil Investigative Demands (“CIDs”) in each of the last four years, noted that qui tam actions increased by 33% last year, and that 480 qui tam actions have already been filed so far in fiscal year 2026.  She attributed this dramatic increase at least in part to enhanced data mining being conducted by DOJ and whistleblowers.  Describing the FCA as a “flexible tool,” Jenny left no doubt that FCA enforcement will remain high even as she acknowledged that it is not “an all-purpose anti-fraud statute.”

Jenny addressed the current administration’s enforcement policies and priorities, also discussing her personal approach to evaluating cases and when she will get involved.

Enforcement Policies and Perspectives

Harm to Individuals and Programs Drive Enforcement

Jenny first made clear what is not unique to this Administration:  DOJ will prioritize FCA enforcement in cases that involve items or services that are dangerous, defective, or otherwise endanger patient health and safety. Cases where there is no harm, or the harm is speculative or theoretical, will be less of a priority. However, Jenny noted that conduct which places patients in harm’s way is problematic, even if that harm never comes to pass. In other words, a defendant’s “luck” is no defense.  In this regard, Jenny warned that she does not find arguments that damages are hard to quantify to be persuasive.  Finally, she noted that DOJ will also act where there is evidence of harm to federal program integrity or taxpayers, including in the context of cases addressing discrimination.

Continued Payment and Common Practices Will Not Insulate Companies from Liability

Jenny also addressed some frequently-advanced arguments addressing FCA materiality and scienter. First, she warned that arguments that conduct is old or a case is “stale” carry little weight because the statutes of limitations already serve as adequate guardrails. That being said, she stated that under her watch DOJ is interested in arguments that the law has developed since the conduct at issue, the law was ambiguous at the time, or that changes in the law or availability of evidence would make a case difficult to prove at trial.

As to materiality, Jenny stated that the government’s continued payment of claims is not dispositive of materiality, which is of course consistent with Escobar.  Jenny noted that continued payment does not necessarily equate to approval and, drawing on her prior experience as the Chief Legal Officer of CMS and Principal Deputy General Counsel of HHS, stated that CMS often pays claims without adequate information. She will need to see evidence of affirmative, informed acceptance by an agency to be persuaded of immateriality, and noted that it may require defendants to engage in discovery in FCA litigation to obtain that evidence.

She also explained that arguments that a practice is common in the industry will fall flat, and may in fact increase enforcement focus because systemic noncompliance is a bigger risk to government programs. She distinguished such arguments from more compelling evidence that the government had knowledge of the practice, the industry believed that the government had knowledge, or there was regulatory ambiguity surrounding the practice.

No Enforcement Based on Sub-Regulatory Guidance

Jenny also reiterated DOJ’s commitment not to rely on sub-regulatory guidance to drive FCA enforcement.  Consistent with views she expressed in an HHS-OGC Advisory Opinion she issued in 2020, the Supreme Court’s decision in Allina, and Attorney General Bondi’s 2025 Memo Reinstating the Prohibition on Improper Guidance Documents, Jenny noted that sub-regulatory guidance “does not have the force and effect of law,” and therefore is an improper basis for enforcement action. She clarified that this remains DOJ’s policy despite the fact that the DOJ Manual provision reflecting this commitment, repealed by the Biden Administration, has not been reinstated.

DOJ’s Increased Exercise of its (c)(2)(A) Dismissal Authority

In 2025, DOJ moved to dismiss 25 qui tam cases under its statutory authority, according to Jenny.  As she noted, that is a small percentage of the 1200+ new cases filed last year (and a vanishingly small percentage of the many thousands of qui tams currently pending and under seal).  Despite those realities, Jenny emphasized that DOJ it is not reluctant to exercise its authority to dismiss and committed to doing so where cases are proven to be meritless or inconsistent with current law and where the allegedly defrauded agency does not support the case. Jenny noted that she evaluates whether dismissal is appropriate at the declination stage of each case, rather than on an ad hoc basis like her predecessors.

Current FCA Enforcement Priorities

Jenny then addressed certain key FCA enforcement priorities.

Healthcare

Jenny touched on three areas of FCA enforcement in the healthcare industry, all of which were previously announced as areas of focus for the DOJ-HHS FCA Working Group, as discussed here:

• Managed Care.DOJ intends to prioritize cases that involve alleged fraud on the Medicare Advantage program and unsupported risk adjustment diagnosis codes, including “one-way adds” based on chart reviews, failures to delete unsupported codes, improper use of queries and addenda to add codes, and unsupported codes added based on home health assessments. Additionally, she underscored her commitment to pursuing FCA enforcement against health plans and brokers, including in cases involving alleged fraudulent enrollment, kickbacks to brokers, denials of care through prior authorization criteria, “cherry-picking”, marketing misrepresentations, and abuse of medical loss ratios.
• Drug Pricing.DOJ will also focus on investigating allegations of non-compliance with rules related to drug pricing and price reporting. Jenny noted that while pricing rules are complex, DOJ will focus on candidness and consistency, especially when statements about pricing to the government differ from external representations. FCA enforcement will also continue to focus on other practices that may contribute to allegedly inflated drug prices, and Jenny called out improper copay assistance practices as one such source of potential liability.
• Unnecessary Services and Substandard Care. Jenny also made clear that DOJ will always focus on allegations involving the government being billed for medically unnecessary services and defective items. She clarified that DOJ will not second-guess legitimate medical decision-making, but it will review services conducted in a matter inconsistent with medical standards. It will also look at whether companies manufactured and sold defective medical products and if, while doing so, manufacturers knowingly misrepresented their compliance with applicable rules.

Violations of Federal Discrimination Laws

Jenny reiterated DOJ’s commitment to enforcement of illegal discrimination through the FCA, clarifying this is targeted at practices that resulted in discrimination on the basis of race, sex, or other protected characteristics, and not merely at diversity, equity and inclusion programs. A further summary of Jenny’s comments on this topic can be found here.

Customs/Tariff Fraud

Jenny noted a 50% increase in trade and customs-based FCA cases in 2025 compared to the prior five-year average. She discussed three primary sources of FCA exposure for importers: misclassification, undervaluation to reduce duties owed, and misstating the country of origin on products to avoid duties. This topic was addressed by another panel at the conference, and a summary of that can be found here.

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