On March 17, 2026, the United States Court of Appeals for the Ninth Circuit issued a significant opinion in United States ex rel. Adventist Health System of West v. AbbVie Inc., [1] reversing the district court’s dismissal of a qui tam complaint brought under the False Claims Act (“FCA”) against four major drug manufacturers. The Ninth Circuit held that the FCA provides an independent mechanism for relators to bring claims alleging fraudulent drug pricing in violation of the Public Health Service Act’s Section 340B Program (“the 340B Program”), [2] even though Section 340B does not provide a private right of action. The ruling has important implications for pharmaceutical manufacturers participating in the Section 340B Program.
New Executive Order Targets DEI Practices by Federal Contractors, Imposes Mandatory Contract Clause and FCA Liability
Continuing his administration’s efforts to eliminate diversity, equity and inclusion (DEI) activities, President Donald Trump signed an executive order, “Addressing DEI Discrimination by Federal Contractors,” on March 26, 2026, that directs all executive departments and agencies to include a new clause in all federal contracts and subcontracts prohibiting what the order defines as “racially discriminatory DEI activities.” The order represents another escalation of the administration’s efforts to restrict DEI programs in the federal contracting space — building on Executive Order 14173 and the Department of Justice’s May 2025 Civil Rights Fraud Initiative — and carries substantial enforcement implications, including potential liability under the False Claims Act (FCA).
Read on for key provisions of the new executive order, analysis of practical implications for federal contractors and subcontractors, and recommended steps for compliance.
New GSA Proposal Could Expose Federally Funded Institutions With Programs Perceived as DEI-Related
The General Services Administration has proposed requiring all federal funding recipients to certify that they do not maintain diversity, equity, inclusion and accessibility programs. Recipients also would also need to certify they are not knowingly hiring or recruiting undocumented staff.
The GSA estimates the proposal would impact approximately 222,760 entities — including colleges and universities. If enacted, the certification requirements would expose grant recipients to potential liability under the False Claims Act. The deadline for public comments is March 30, 2026.
Read on to learn more about the GSA proposal and its potential impacts on federally funded institutions.
DAAG Provides Views on FCA Enforcement Focus: Targeting Discrimination, Not DEI Programs Per Se
At the Federal Bar Association’s 2026 Qui Tam Conference on Feb. 19, 2026, Deputy Assistant Attorney General Brenna Jenny delivered a keynote speech that provided insight into the DOJ’s enforcement priorities and viewpoints on FCA enforcement. From her perspective, the DOJ is not investigating federal contractors and grant recipients for having DEI programs, but for potentially engaging in discrimination through their implementation of those programs. She emphasized that companies could be found to engage in discrimination with or without DEI programs and can also operate DEI programs without engaging in discrimination.
Read on to learn more about the specific programs and practices that, according to Jenny, the DOJ has been reviewing for potential violations of federal antidiscrimination laws.
HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch
In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services released a special advisory bulletin on Jan. 27, 2026, outlining the Federal Anti-Kickback Statute implications for direct-to-consumer drug sales. The OIG concludes that the risk of AKS violations is minimal if certain guidelines are followed, adding that its bulletin “clears the path” for DTC programs including the TrumpRx program. However, a letter from Sens. Richard Durbin, Elizabeth Warren, and Peter Welch to the OIG suggests that not all stakeholders share this confidence in TrumpRx, citing to concerns arising from a recent investigation into other DTC platforms. Pharmaceutical companies and other stakeholders can submit public comments until March 30, 2026. Read on to learn more about the guidance and what the pharmaceutical industry should know.
DoW Announces Line-by-Line Review of Certain 8(a) Contracts Amid Government-wide Scrutiny of the 8(a) Program
The Jan. 16, 2026, announcement by Secretary of War Pete Hegseth that “every small business, sole source, 8(a) contract that is over $20 million” will undergo a “line by line review” raises significant questions and considerations for all government contractors that participate in 8(a) program activities. For example, 8(a) participants that are currently performing – or that recently performed – set-aside or sole-source awards may want to consider developing a complete picture of their program-based portfolio, including awarding agency, contract value, period of performance, applicable small-business and socioeconomic requirements, and any recertification obligations. As part of that analysis, 8(a) participants may want to further assess where on the risk spectrum the company’s participation may sit and, if appropriate, prioritize review readiness.
Read on to learn more about how the policy developed over the past seven months and other considerations for contractors.
Creation of DOJ Fraud Division Signals Increased White-Collar Enforcement
On January 8, 2026, the White House announced the establishment of a new division of the Department of Justice: The Division for National Fraud Enforcement. In a White House Fact Sheet, the Trump Administration stated that the new division will “combat the rampant and pervasive problem of fraud in the United States,” and “enforce the Federal criminal and civil laws against fraud targeting Federal government programs, Federally funded benefits, businesses, nonprofits, and private citizens nationwide.”
OIG Solicits Proposals for AKS Safe Harbors and Special Fraud Alerts
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is accepting public proposals for new or modified safe harbor provisions under the Federal Anti-Kickback Statute, as well as recommendations for new Special Fraud Alerts. The deadline to submit ideas is 5 p.m. ET on February 9, 2026.
OIG Issues Remote Patient Monitoring Report: Billing Pitfalls and Compliance Risks
On August 25, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a report analyzing Medicare billing practices for remote patient monitoring (“RPM”) services during 2024. As RPM technologies have matured and become more accessible, their availability has driven widespread adoption and enhanced patient care by enabling continuous, data-informed management outside the clinic; at the same time, this proliferation has attracted heightened government attention. The report highlights the rapid growth of RPM utilization and payments, identifies patterns that may be indicators of potential fraud and abuse, and reiterates the need for enhanced oversight by the Centers for Medicare & Medicaid (“CMS”). The OIG’s findings assist providers in assessing regulatory and compliance implications.
Marketing, Misconduct and Healthcare: Ninth Circuit Issues First EKRA Appellate Ruling
On July 11, 2025, in United States v. Schena, the U.S. Court of Appeals for the Ninth Circuit issued the first appellate decision interpreting the Eliminating Kickbacks in Recovery Act (“EKRA”). The decision marks a significant development in EKRA’s enforcement, as it represents the first time a federal appeals court has addressed EKRA’s reach and moved toward some clarity in its application to marketing arrangements within the healthcare industry, particularly in the often-discussed lab context.