On May 15, 2026, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 26-11 (the “Opinion”), a favorable opinion for a proposed arrangement that involved providing patients a free supplemental cancer screening report (the “Proposed Arrangement”). The Opinion provides guidance for healthcare companies navigating the intersection of innovative diagnostic offerings and federal fraud and abuse laws.
Across the healthcare industry, providers are increasingly relying on AI-assisted billing tools to automate medical coding, prior authorization workflows, and the submission of claims to Medicare, Medicaid and other federal payors. The efficiency gains can be substantial, as can the heightened False Claims Act (FCA) exposure these systems can create. As AI continues to develop and becomes more widely integrated into healthcare billing, relators and prosecutors are likely to explore new avenues for evaluating, and litigating, how these tools are deployed, monitored and overseen.
Like every billing system, AI-assisted billing tools can make mistakes. However, AI-assisted systems can scale those mistakes across thousands of claims, and the records those systems generate may make it easier for the government or relators to argue that a provider’s submission of those claims violated the FCA.
Read on to learn what healthcare companies should know when deploying AI-assisted billing, and best practices for getting ahead of FCA risk.
As part of the Trump administration’s efforts to implement a broad range of executive orders targeting diversity programs and other policy priorities in federal grantmaking, OMB published a proposed rule on May 29, 2026, that would substantially revise the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards (2 C.F.R. part 200). Organizations that receive federal funds should start considering a host of actions to prepare for these changes if implemented, including determining whether any current programs and policies that exhibit DEI characteristics should continue and, if so, documenting their business rationale and legal basis. Organizations will also be required to ensure that they, subrecipients, and downstream contractors update and maintain policies that follow the new requirements, especially as agencies may have broader powers to terminate funding deemed no longer to advance “the national interest.” Finally, organizations should consider submitting public comments to alert the government of provisions that would benefit from more clarity or may cause undue burdens.
Read on to learn more about the background and implementation of these policies.
On May 20, 2026, the DOJ announced a settlement under the False Claims Act (FCA) with two Canada-based steel companies, Farjess Inc. and Royal Canadian Steel Inc., and their part-owner and president, Feroz Jessani. They agreed to pay $19 million to resolve allegations that they knowingly and improperly misrepresented the country of origin and failed to pay duties owed on flat-rolled steel manufactured in Europe and Asia. The settlement underscores the government’s continued and aggressive use of the FCA to pursue Trump administration policy priorities, including the active implementation of tariffs and customs duties, and reinforces the importance of accurate country-of-origin declarations when importing foreign materials and products.
Read on to learn more about the settlement and its implications for companies engaged in importing goods into the United States.
The DOJ’s National Fraud Enforcement Division announced on April 30, 2026, the formation of the West Coast Health Care Fraud Strike Force, a multi-district enforcement initiative spanning Arizona, Nevada and the Northern District of California. Announced by Assistant Attorney General Colin McDonald, the new Strike Force signals a significant escalation of federal healthcare fraud enforcement in the broader West Coast region and warrants close attention from healthcare providers, technology companies and other industry participants operating in the area.
Read on to learn more about the Strike Force and what industry participants should do to prepare.
The U.S. Department of Health and Human Services Office of Inspector General (OIG) updated its FAQs on Fraud and Abuse Authorities to add a new answer on fair market value (FMV) in FAQ 17 and revise the answer on how the physician self-referral law (Stark Law) overlaps with the federal Anti-Kickback Statute (AKS) in FAQ 4. The takeaway from FAQ 4 and FAQ 17 is clear: An arrangement can violate the AKS even if the compensation is FMV or the arrangement fits within a Stark Law exception.
This update is not new law, but it is a strong reminder that AKS liability turns on intent, not on FMV or Stark Law compliance alone.
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.
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.
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.
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.