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
The FCA Insider
Insights and updates on False Claims Act Litigation
The FCA Insider, published by McGuireWoods LLP, focuses on legal developments and compliance issues related to healthcare fraud and abuse, particularly under statutes like the False Claims Act, Anti-Kickback Statute, and the Eliminating Kickbacks in Recovery Act (EKRA). The blog covers enforcement actions, regulatory guidance, and court decisions affecting healthcare providers, payors, and related entities. Topics include Medicare and Medicaid billing practices, fraud investigations, compliance risks in remote patient monitoring, marketing and referral arrangements, and settlements involving healthcare providers. It also addresses the implications of government audits and whistleblower actions in the healthcare sector.
Latest from The FCA Insider - Page 2
Long Anticipated Medicare Advantage Compliance Guidance Heightens Investor and Provider Scrutiny
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…
CMS Reaches $100 Million in Stark Self-Disclosure Settlements
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…
Ninth Circuit Ruling in FCA Case Predicated on 340B Pricing Violations Has Significant Implications for Pharma Manufacturers
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…
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…
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.…
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…
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,…
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…
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…