Federal Health Law Enforcement in 2025

Much has been written about the healthcare policy changes implemented by the 2025 Trump administration. President Trump has issued numerous Executive Orders that establish new policies and rescind actions taken by previous administrations. Robert F. Kennedy, Jr. is overhauling and refocusing Health & Human Services. Dr. Mehmet Oz is implementing new policies at the Center for Medicare and Medicaid Services and auditing Medicare Advantage plans (of which he has been a historical proponent). The Food & Drug Administration is revising its Generally Regarded as Safe standards, fast-tracking approvals of new drugs, minimizing animal testing, and increasing its use of Artificial Intelligence. The National Institute of Health is amending its peer review process.

Much less has been said about the Administration’s enforcement activities within the healthcare industry during this time. That may be due to the fact that while healthcare policy is changing almost daily, enforcement activity has not. Just as there was no abatement in regulatory actions from the Obama administration to the first Trump administration, there has not been a reduction from the Biden administration to the second Trump administration. Nevertheless, from a legal perspective, it is just as important to be aware of how the government is enforcing the laws as it is to watch how policy is changing. A summary of some of these activities for three agencies follows.

Department of Justice

United States Attorney General Pam Bondi has a history of healthcare enforcement dating from her time as Florida’s Attorney General. While serving in that role, Ms. Bondi actively targeted pill mills, drug distributors, and implemented prescription monitoring. Further, Deputy Attorney General Todd Blanche and Principal Assistant Deputy Attorney General Emile Bove, both former Assistant US Attorneys from New York, have a history of prosecuting white-collar crime. The foundation of these three DOJ leaders has led to continued aggressive enforcement activity.

Since January 2025, the DOJ has:

• Negotiated numerous False Claims Act settlements, many involving improper Medicare arrangements. Reports indicate these settlements already exceed $1 billion through May 2025, consistent with last year’s $2.9 billion in recoveries.
• Issued a Criminal Division memo (May 2025), identifying healthcare fraud and abuse as the Department’s top white-collar priority, encouraging self-reporting and investigation efficiency.
• Supported the creation of Medicare/Medicaid fraud units within numerous U.S. Attorney’s Offices.
• Maintained an active antitrust stance, continuing the challenge to United Health Group’s proposed acquisition of Amedisys.

Health and Human Services

In March 2025, HHS:

• Consolidated several agencies into the new Administration for a Healthy America.
• Created a new Assistant Secretary for Enforcement role to oversee the Departmental Appeals Board, the Office of Medicare Hearings and Appeals, and the Office for Civil Rights (which enforces HIPAA), aiming to combat waste, fraud, and abuse more efficiently.

Although Christi Grimm, who had served as Inspector General since 2020, was dismissed by President Trump, HHS’s Acting Inspector General and five Deputy Inspectors General continue to aggressively pursue enforcement actions, which are expected to increase under the new leadership structure.

The Spring 2025 Semiannual Report from the HHS Office of Inspector General reflects this focus:

• $16.61 billion in savings and receivables identified, including an estimated $7.5 billion from Medicare Advantage Risk Adjustment fraud and $465 million in improper Medicare Part D payments.
• 1,503 exclusions from federally funded health programs.
• 1,209 referrals for prosecution.
• 349 criminal actions resulting in convictions or pre-trial diversion.
• 395 civil actions resolved.
• 298 new criminal cases initiated.

In addition, HHS is increasing its focus on price transparency, following a February Executive Order that requires enforcement of hospital/insurance price disclosures based on actual pricing.

Federal Trade Commission

FTC Chair Andrew Ferguson, a Commissioner since 2024, has maintained a consistent antitrust agenda:

• Blocking the proposed merger of two medical device coating manufacturers.
• Targeting Pharmacy Benefit Managers over insulin pricing.
• Continuing to apply the 2023 Merger Guidelines, which may lead to more transactions being deemed anticompetitive.

Additionally, as a Commissioner, Ferguson opposed the proposed FTC rule prohibiting non-compete agreements — no further action is currently anticipated on that rule.

Conclusion

The Trump administration is making significant changes to healthcare policy. However, based on activity during the first half of 2025, it is clear that aggressive prosecution and healthcare law enforcement will continue. Compliance should remain a priority for healthcare providers.