Regulatory April 14, 2026

GSA AI Procurement Rules Would Introduce New Disclosure and Use-Rights Requirements for Federal Contractors

By Jason M. Vespoli, Edwin O. Childs, Andrew Konia, Abram J. Pafford, John Sullivan and Sophie Marsh

The General Services Administration Federal Acquisition Service has released draft contract terms and conditions related to AI-related procurements through a new proposed GSAR clause 552.239-7001, “Basic Safeguarding of Artificial Intelligence Systems” (February 2026), that would impose material new requirements on contractors and service providers supplying AI capabilities to the federal government. If adopted, the clause would be inserted into all solicitations and contracts for AI capabilities and would govern data rights, disclosure obligations, security protocols and performance standards for AI systems used in federal operations. Federal contractors, technology vendors, and their in-house operations and counsel teams should closely review the proposed terms, as they represent one of the most comprehensive efforts to date to regulate the procurement and use of AI systems across the federal enterprise.

The proposed clause would significantly alter the landscape for companies providing AI capabilities to the federal government. Read on to learn more about the proposed rule and its implications.

CMS Guidance, OIG, Regulatory April 9, 2026

Long Anticipated Medicare Advantage Compliance Guidance Heightens Investor and Provider Scrutiny

By Francesca Ozinal and Timothy Fry

In February 2026, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued its highly anticipated Industry Compliance Program Guidance for Medicare Advantage (MA ICPG), the first such compliance guidance for the MA industry in over 25 years. The MA ICPG is the second industry segment-specific compliance guidance published in a series for providers, suppliers, and other participants in the health care industry. The first was a 2024 nursing facility ICPG.

The guidance comes as MA now covers more than half of all Medicare enrollees. The program’s capitated payment structure generally pays Medicare Advantage Organizations a fixed monthly amount per enrollee. This model creates financial incentives that run throughout the entire MA ecosystem, touching plans, providers, investors and vendors alike, but in a manner different from traditional fee-for-service. While the MA ICPG is voluntary, nonbinding guidance, it carries significant practical weight.

Read on to learn more about the guidance and why investors, owners and operators of MA-related businesses as well as providers contracting with MA plans should treat the MA ICPG as a signal of HHS-OIG’s current enforcement priorities and a benchmark against which their compliance programs will be measured.

CMS Guidance, Stark Law April 6, 2026

CMS Reaches $100 Million in Stark Self-Disclosure Settlements

By Kristen H. Chang, Timothy Fry, Gretchen Heinze Townshend and Varsha Gadani

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2025 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). Generally, two notable items arise from our annual review of CMS’ settlement data. First, CMS has now reported aggregate settlements reaching $105,090,031. Second, CMS reported the largest Stark Law settlement: $2,683,066 more than doubling the previous record high of a single settlement from 2018. Read on for more with respect to the CMS settlement data and potential lessons.

Defense Arguments, FCA Litigation April 6, 2026

Ninth Circuit Ruling in FCA Case Predicated on 340B Pricing Violations Has Significant Implications for Pharma Manufacturers

By Craig B. Bleifer, Michael J. Podberesky and Jessica L. Vaughn, Ph.D.

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.

DOJ, FCA Litigation, Uncategorized April 2, 2026

New Executive Order Targets DEI Practices by Federal Contractors, Imposes Mandatory Contract Clause and FCA Liability

By Edwin O. Childs, Abram J. Pafford, Jack White, John Adams, Elissa Baur, James Dougherty, Brett Barnett, Michael J. Podberesky, David Greenspan, John E. Thomas, Jr., William Doyle, Elena Marcuss, Michael R. Phillips, Jason M. Vespoli, John Sullivan and Sophie Marsh

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.

Regulatory March 23, 2026

New GSA Proposal Could Expose Federally Funded Institutions With Programs Perceived as DEI-Related

By Brandi G. Howard, Farnaz Farkish Thompson, Jack White, Sarah Wake, Michael J. Podberesky, Edwin O. Childs, Maricris Prendingue and John Sullivan

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.

DOJ February 26, 2026

DAAG Provides Views on FCA Enforcement Focus: Targeting Discrimination, Not DEI Programs Per Se

By Edwin O. Childs, Brett Barnett, John Adams, Jack White, Brandi G. Howard, Elissa Baur, John S. Moran, Michael J. Podberesky, Jason M. Vespoli, Sophie Marsh and John Sullivan

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.

OIG, Regulatory February 5, 2026

HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch

By Craig B. Bleifer and Jessica L. Vaughn, Ph.D.

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.

DOJ January 22, 2026

DoW Announces Line-by-Line Review of Certain 8(a) Contracts Amid Government-wide Scrutiny of the 8(a) Program

By Edwin O. Childs, Brett Barnett, Michael J. Podberesky, Abram J. Pafford, John Adams, Jack White, Elissa Baur, Benjamin L. Hatch, Michael Scoville, John S. Moran, James Dougherty, Jason M. Vespoli and McGuireWoods LLP

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.

DOJ January 12, 2026

Creation of DOJ Fraud Division Signals Increased White-Collar Enforcement

By Brett Barnett, Edwin O. Childs, John Adams, Ryan Buchanan, Alex J. Brackett, M. Cole Davidson, Mindy Sauter, Michael J. Podberesky, Stephen Weiss, David Pivnick, Shalika Shah Kotiya, Brandi G. Howard, Jack White and Steven McCool

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.”

The FCA Insider

Insights and updates on False Claims Act Litigation