AKS, Stark, EKRA, and Self-Disclosure Walked Into a Panel …

Healthcare enforcement took center stage during a panel at the 2026 ABA White Collar Crime Institute in San Diego earlier today. The panel dug into the latest developments under the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark Law), and the Eliminating Kickbacks in Recovery Act (EKRA), along with how self-disclosure is reshaping the way companies resolve healthcare fraud issues.

Arnold & Porter partner Lisa Re joined fellow panelists to discuss these trends, including what may be the most thorny questions that keep healthcare lawyers up at night: what are the practical consequences of exclusion, and what are the strategic considerations companies face when deciding whether to disclose potential violations to the U.S. Department of Health and Human Services Office of Inspector General (OIG)?

Anti-Kickback Statute: Familiar Risks, Expanding Scrutiny

The panel kicked off with AKS enforcement trends, and the familiar themes are still front and center. Enforcement authorities continue to focus on speaker program arrangements, recruiting and marketing, and compensation structures tied to referrals.

Recent court decisions also are worth watching. Panelists discussed decisions that narrow the traditional “one purpose” test in certain contexts, along with cases that examine marketing arrangements under the lens of the AKS.

One practical takeaway: federal agencies are not the only enforcement players that companies should pay attention to. State attorneys general and Medicaid fraud control units are becoming increasingly active in healthcare fraud investigations. Companies should evaluate state enforcement risk alongside potential actions by the U.S. Department of Justice (DOJ), OIG, and Centers for Medicare & Medicaid Services.

Stark Law and FCA Theories

Though the Stark Law is a civil statute, it keeps showing up in False Claims Act (FCA) cases — often in matters where physician compensation arrangements allegedly drove referrals they shouldn't have.

The panel highlighted several recent enforcement actions, including cases involving alleged sham medical directorship arrangements and settlements involving home health providers. The takeaway: regulators continue to focus on referral relationships and how physicians get paid.

At the same time, the panel noted that CMS guidance has modernized aspects of the Stark Law framework. For example, CMS has clarified that percentage-based compensation arrangements are not automatically prohibited, reflecting how CMS now reads the statute more flexibly in light of evolving healthcare payment models.

EKRA and the First Appellate Decision

The conversation then shifted to EKRA, a statute that keeps raising questions for providers, laboratories, and life sciences companies.

Panelists focused on the Ninth Circuit’s decision in United States v. Schena, the first appellate interpretation of EKRA. The court concluded that the statute can apply beyond federal healthcare programs and sweep in conduct involving private insurers.

The decision also took on commission-based marketing compensation. According to the panelists, the court in Schena suggested that such compensation alone does not necessarily violate EKRA, as long as it doesn’t improperly influence referrals.

Panelists noted that courts frequently look to AKS precedent when interpreting EKRA. That means existing AKS case law could help shape arguments in future EKRA cases.

OIG Exclusion Authority

The panelists then discussed the administrative consequences that can arise in healthcare enforcement matters. Lisa Re discussed OIG’s exclusion authority and why white collar defense attorneys representing healthcare providers need to pay attention.

Under Section 1128 of the Social Security Act, OIG may exclude individuals and entities from participating in federal healthcare programs. Some offenses trigger mandatory exclusion, while others give OIG discretion to impose exclusion, including conduct involving unlawful kickbacks.

The stakes are high for providers. Once excluded, individuals and entities cannot receive payment from Medicare, Medicaid, or other federal healthcare programs. As Re emphasized, counsel advising healthcare clients must carefully consider these risks when negotiating plea agreements or other resolutions.

The OIG Self-Disclosure Protocol

The panel wrapped up with a discussion of the OIG Health Care Fraud Self-Disclosure Protocol (SDP). Re walked through how the protocol came about, what it's designed to do, and how it differs from DOJ’s voluntary self-disclosure policies familiar to many white collar practitioners.

The SDP gives companies a structured process to disclose potential violations involving federal healthcare programs directly to OIG. The goal is to resolve issues before the government comes knocking.

But it’s not a simple call. Healthcare companies weighing disclosure need to consider potential criminal exposure under the AKS, civil liability under the FCA, and administrative sanctions like exclusion. For many providers, avoiding exclusion or a Corporate Integrity Agreement is a central consideration.

The protocol can also provide predictability. Companies that disclose through the SDP may resolve liability for approximately 1.5 times damages and may avoid both exclusion and a Corporate Integrity Agreement. That's a real incentive to come forward.

Recent settlements show the protocol in practice. Several companies disclosed compensation arrangements tied to the volume or value of referrals. Others flagged in-kind benefits provided to referral sources, such as free access to laboratory systems. These matters were resolved through the SDP after companies voluntarily reported the conduct to OIG.

Key Takeaway

The panel highlighted several themes shaping healthcare enforcement today. Financial relationships that may influence referrals remain a central focus for regulators and prosecutors. At the same time, newer areas like digital health and cybersecurity are drawing increasing scrutiny.

For practitioners advising healthcare clients, understanding the full range of enforcement consequences — and knowing the when and how to use self-disclosure — remains essential.

More to come here from San Diego! Continue to follow Enforcement Edge for updates.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.