Healthcare fraud enforcement trends: What to expect under the new administration

Despite administration changes, healthcare fraud enforcement is likely to remain a priority for the DOJ, expert says.

Lee Cortes, partner at Arnold & Porter, discussed the future of healthcare fraud enforcement under the Trump administration at the recent Pharmaceutical Compliance Congress.

Drawing upon his experience as the former chief of the Health Care Fraud Unit and executive assistant US Attorney in New Jersey, Cortes emphasized the importance of healthcare fraud enforcement across administrations, noting its prominence during President Trump’s first administration and its likely continuation under the current one.

“Healthcare fraud and life sciences, any kickback statute, False Claims Act enforcement—all of those were a significant priority, not only for my U.S. Attorney but for our counterparts at Main Justice in both the criminal side and on the civil side.

“There were significant expansions in the number of prosecutors that were doing this kind of work in Trump one, and they really cared about, the types of cases we were doing, about moving them faster, about not only corporate but individual accountability,” he continued.

Annual announcements of recoveries under the False Claims Act and large healthcare fraud takedowns further underscored the DOJ’s commitment to combating fraud, waste, and abuse, he noted.

He pointed to developments in the last couple months, such as the healthcare Strike Force’s announcement of four trial victories, as indication that enforcement efforts will remain robust.

In June, the Justice Department announced the results of its 2025 National Health Care Fraud Takedown, which resulted in criminal charges against 324 defendants, including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals for their alleged participation in various healthcare fraud schemes involving over $14.6 billion in intended loss (the pecuniary harm that the defendant purposely sought to inflict).

Cortes stressed the lengthy timeline of healthcare fraud cases, which ensures that ongoing investigations will persist regardless of political changes.

“These cases take time from the initial subpoena or CID [Civil Investigative Demand] to resolution. They don’t just stop. Cases that are in progress today started a couple years ago and aren’t going to finish for a couple of years hence.”

This continuity reflects the DOJ’s commitment to seeing cases through to resolution, he further noted.

Key enforcement areas

Laboratory testing

Cortez identified labs, including recovery homes, clinical treatment facilities, and clinical laboratories, as a significant focus for enforcement, citing criminal charges and False Claims Act resolutions involving lab principals and entities. He explained the DOJ’s focus on relationships between large companies and third parties, noting that labs often have less robust compliance programs.

“Labs are one of those [third parties]. They tend to be smaller. They tend to have less defined compliance programs,” Cortes explained.

He also highlighted the Eliminating Kickbacks in Recovery Act, a “new tool” for federal prosecutors targeting kickbacks in the lab space. “I think labs are a very, very important touch point for folks to expect that this is something that is going to be that federal prosecutors or/and False Claims Act practitioners are going to be thinking about.”

Digital health/telehealth

Digital health and telehealth are also “evergreen topics” that have been under scrutiny since the first Trump administration and that is “going to continue,” according to Cortes.

He pointed to telehealth-related schemes involving kickbacks for referrals and highlighted a notable case involving Done Global, a digital health company.

“That is a case where two executives behind the company, the CEO and the chief medical officer, are both facing criminal charges brought by the US Attorney's Office in Central District of California, and Main Justice for healthcare fraud and controlled substance violations related to telehealth,” he explained.

Cortes explained that this case combines enforcement priorities around controlled substances (e.g., Adderall) and telehealth, signaling heightened scrutiny in areas with overlapping risks.
“Where a company is dealing with two enforcement areas that the government is looking at, the scrutiny of that is going to be pretty high,” he further added.

Anti-Kickback Statute

Cortes briefly summarized the DOJ’s ongoing focus on anti-kickback statute enforcement, particularly in relationships between companies, healthcare practitioners, pharmacies, and others, noting that “this is an area that they are always going to continue to focus on.”

“This is a topic federal prosecutors will continue to prioritize,” he said.

Medicare Advantage

Another priority area Cortes noted is Medicare Advantage. He said the Health and Human Services Office of the Inspector General (OIG) issued a special fraud alert about marketing arrangements that the OIG was finding suspect.

“Typically speaking, when OIG issues a special fraud alert, there’s a reason that they’re doing that, and it is a bit of a signal that enforcement in those areas is going to come … something that they are going to be prioritizing.”

Other enforcement areas to watch

Although the Foreign Corrupt Practices Act (FCPA) enforcement has reportedly slowed, Cortes advised against making significant changes to compliance programs due to inconsistent enforcement. He noted that while some cases have been adjourned or dismissed, “others have gone on like they haven’t just pulled the plug on every case.”

Additionally, he emphasized the lengthy statute of limitations for FCPA cases and the uncertainty surrounding future enforcement priorities.

“It’s way too early to really be making broad changes about how you’re going to deal with these risks,” Cortes said.

Meanwhile, the president has issued an executive order emphasizing the importance of not penalizing American companies under the FCPA, Cortes further noted. However, he explained that the FCPA applies broadly to American companies, American subsidiaries of foreign companies, and foreign companies, raising questions about whether enforcement priorities will differentiate between these groups.

Lastly, there is an anticipated rise in foreign bribery enforcement by other countries, “in the wake of the government’s announcement [executive order],” Cortes stated.

The DOJ is shifting its approach to case initiation under statutes like the Foreign Agents Registration Act (FARA), which “has been suspended.”

Historically, US Attorney’s offices required approval from Main Justice to open cases under certain statutes. However, Cortes noted a trend toward decentralizing this process, with individual U.S. Attorneys gaining more discretion, as “there’s a bit of a signal that that is going to loosen up a bit.”

Learn more about the latest enforcement at our upcoming conference.

DepositPhotos/aruba2000