Health Law Advisor

On June 23, 2026, the U.S. Department of Justice (“DOJ”) announced the results of the annual National Health Care Fraud Takedown (“2026 Takedown”)—the first under DOJ’s new National Fraud Enforcement Division (“NFED”) announced on April 7. This year, the 2026 Takedown charged 455 defendants in connection with more than $6.5 billion in alleged fraud.

Although much of the content of the prosecutions is the same as in past years (e.g. wound care, opioids), Medicaid fraud—long the province of state Medicaid Fraud Control Units (“MFCUs”)—featured prominently in the 2026 Takedown. DOJ claims to have charged the largest number of Medicaid fraud defendants and Medicaid fraud loss in DOJ history: 295 defendants and over $518 million in alleged false claims submitted to Medicaid. Per the DOJ press release, the MFCUs of all 50 states participated, the highest number ever.

The Highlights

• Accelerated FCA Investigative Timeline: The U.S. Department of Justice (DOJ) is taking new steps to implement the directives of Executive Order 14395 of March 16, 2026, “Establishing the Task Force To Eliminate Fraud,” by expediting the review for newly filed False Claims Act (FCA) qui tam actions involving federally funded state-administered benefits programs. The May 27, 2026, memorandum from Assistant Attorney General Brett A. Shumate (“Shumate Memo”) states that all newly filed state-administered benefits program fraud qui tam actions will now be reviewed by DOJ in 60 to 120 days after filing to determine if the government will continue its investigation, permit the whistleblower to proceed, or act to dismiss the case.
• DOJ Reaffirmation of Relator Authority: The Shumate Memo reaffirms DOJ’s position that whistleblowers may “stand in the shoes” of the government and indicates that the agency will let relators lead litigation subject to DOJ’s “oversight and ultimate control.”
• Automatic Criminal and Administrative Referrals: New benefits program fraud qui tam matters will be automatically referred to the Criminal Division and/or the National Fraud Enforcement Division for evaluation of potential criminal violations and to the affected agency for potential administrative action, including payment suspension.

On April 3, 2026, the director of the Office of Management and Budget submitted to Congress President Donald Trump’s budget for 2027—proposing $111.1 billion in discretionary budget authority for the U.S. Department of Health and Human Services (HHS) for Fiscal Year 2027, beginning October 1, 2026, and ending September 30, 2027. The number represents a $15.8 billion or 12.5 percent decrease from the 2026 enacted level and suggests ongoing emphasis on combatting improper payments and practices in health care. The proposed budget investments also signal potential shifts that will impact service delivery for certain communities and business operations for entities that contract with the federal government or federal government grantees. We’ve noted the following key takeaways from the HHS Budget in Brief on these points, below.

On January 16, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-01, offering clarity as to whether a manufacturer may waive patient cost-sharing amounts for certain insured individuals receiving its clinical diagnostic test without triggering liability under the Federal health care fraud and abuse laws.

On August 29, 2025, the U.S. Department of Justice (DOJ) announced the creation of a new Trade Fraud Task Force (“Task Force”).

DOJ touts this cross-agency initiative as being designed “to aggressively pursue enforcement actions against any parties who seek to evade tariffs and other duties”—promising “robust enforcement against importers and other parties who seek to defraud the United States.”

Created to further the administration’s “America First Trade Policy” announced on January 20, 2025, the Task Force will consist of civil and criminal components of the DOJ along with U.S. Customs and Border Protection and Homeland Security Investigations. It will focus on ensuring compliance with trade laws, including payment of all tariffs and duties (e.g., antidumping and countervailing duties, Section 301 tariffs, and other customs obligations). DOJ promises increased parallel civil and criminal actions under the False Claims Act (FCA), Tariff Act, and federal criminal statutes related to trade fraud and conspiracy.

On May 12, 2025, the U.S. Department of Justice’s Criminal Division released a new guidance memo on white-collar enforcement priorities in the Trump Administration entitled “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime.” In this memo, and the accompanying speech by Matthew R. Galeotti, the Trump  Administration’s appointed Head of the Criminal Division, the DOJ reiterated its previously stated commitment to prosecuting illegal immigration, drug cartels, and transnational criminal organizations. For the first time in the new Administration, however, the DOJ clearly articulated new white-collar enforcement priorities, directing Criminal Division white-collar prosecutors to follow three core tenets: focus, fairness, and efficiency. As detailed below, the new memo sets forth the following three priorities:

1. Focus on High-Impact Waste, Fraud, and Abuse Harming Vulnerable Taxpayers

It should be no surprise that the administration is targeting actors that profit through “waste, fraud, and abuse.” The memo sets clear priorities for its prosecutors to investigate, listing as the #1 priority health care fraud and federal program and procurement fraud.  The memo goes on to provide a top 10 list of “high-impact areas”, with “trade and customs fraud, including tariff evasion” as #2.  Heavy focus is given to fraud perpetrated by foreign actors and conduct threatening U.S. national security. Also listed is fraud victimizing U.S. investors, including elder fraud and Ponzi schemes. Appearing as #8 on the list is violations of the Controlled Substances Act and the Federal Food, Drug and Cosmetic Act, including the creation of counterfeit pills laced with fentanyl and the “unlawful distribution of opioids by medical professionals and companies.”

Despite recent welcome news to the home health agency (“HHA”) industry in Florida, Illinois, Michigan, and Texas following an end to Centers for Medicare & Medicaid Services’ ("CMS’s") long-standing HHA provider enrollment moratoria, CMS subsequently announced that it would place some newly enrolled HHAs in a provisional period of enhanced oversight. The purpose of the enhanced oversight period and the corresponding additional restrictions placed on certain HHAs is to help CMS address and closely monitor fraud, waste, and abuse concerns in the HHA industry, thus ...

A recent settlement demonstrates the importance of compliant structuring of lending arrangements in the health care industry. The failure to consider health care fraud and abuse risks in connection with lending arrangements can lead to extremely costly consequences.

On April 27, 2017, the Department of Justice ("DOJ") announced that it reached an $18 Million settlement with a hospital operated by Indiana University Health and a federally qualified health center ("FQHC") operated by HealthNet. United States et al. ex rel. Robinson v. Indiana University Health, Inc. et al., Case No. 1:13-cv-2009-TWP-MJD (S.D. Ind.).  As alleged by Judith Robinson, the qui tam relator ("Relator"), from May 1, 2013 through Aug. 30, 2016, Indiana University Health provided HealthNet with an interest free line of credit, which consistently exceeded $10 million.  It was further alleged that HealthNet was not expected to repay a substantial portion of the loan and that the transaction was intended to induce HealthNet to refer its OB/GYN patients to Indiana University.

While neither Indiana University Health nor HealthNet have made any admissions of wrongdoing, each will pay approximately $5.1 million to the United States and $3.9 million to the State of Indiana. According to the DOJ and the Relator, the alleged conduct violated the Federal Anti-Kickback Statute and the Federal False Claims Act.

For more details on the underlying arrangement and practical takeaways . . .

Healthcare Fraud and Abuse is an ever growing problem.  The Federal government has taken several steps in its enforcement efforts to cut down on health care fraud.  It is estimated that health care fraud costs the United States about $80 billion per year.  And it continues to rise in an alarming manner, as total U.S. health care spending continues to rise, currently topping $2.7 trillion.

In the last year, spending on home health care has increased over 5 percent from previous years.  Since 2000, the senior population has increased by 15.1% versus 9.7% for the population as a whole.  According ...