DOJ Declination Offers Roadmap for Healthcare Companies

On March 10, 2026, the DOJ released its first department-wide CEP, superseding the patchwork of component-specific and U.S. Attorney’s Office-level corporate enforcement programs that had previously governed self-disclosure incentives across the DOJ. As we previously discussed, the CEP establishes a single, nationwide framework intended to provide consistency and predictability for companies evaluating whether to voluntarily disclose corporate misconduct.

Part I of the CEP outlines the DOJ’s “commit[ment] to transparently describing the benefits a company may earn through voluntarily self-disclosing misconduct” and sets forth factors that companies must meet to obtain a declination. Until this week, however, it was unclear how, and more importantly if, companies could realistically reap the benefits of the CEP.

The Significance of the Campus Eye Resolution

On July 29, 2026, the DOJ announced the resolution of a criminal healthcare fraud investigation into Campus Eye Management Holdings, LLC, and its wholly-owned subsidiary, Campus Eye Management, LLC.

According to its declination letter, DOJ claimed that from approximately 2015 through March 2023, Campus Eye’s founder E. Bruce DiDonato orchestrated schemes to (1) bill Medicare and other insurers for duplicative and medically unnecessary diagnostic tests performed in connection with surgeries at an affiliated surgery center, and (2) pay illegal kickbacks and bribes to referring physicians for patient referrals tied to those tests. DiDonato caused the submission of more than $3 million in fraudulent claims to Medicare and other insurers, of which Medicare paid approximately $1 million. After DiDonato received large reimbursements from Medicare, he sold part of the Campus Eye business to private equity investors.

Although DiDonato allegedly used Campus Eye as the mouthpiece through which he perpetuated the fraud, the outcomes for the company and DiDonato are markedly different. DiDonato has been indicted on seven counts of conspiracy to commit healthcare fraud, conspiracy to violate the Anti-Kickback Statute, and healthcare fraud, carrying potential penalties of up to 10 years’ imprisonment per count. Campus Eye, on the other hand, will not be prosecuted and will pay a disgorgement of $1 million (reduced from $3.7 million based on an inability-to-pay analysis).

In resolving its investigation into Campus Eye and announcing its declination, the DOJ prominently credited Campus Eye’s compliance with every factor outlined in the CEP. According to the resolution, Campus Eye timely and voluntarily self-disclosed the misconduct, fully and proactively cooperated, timely and appropriately remediated the misconduct, had no aggravating circumstances, and agreed to disgorge the ill-gotten gains.

This resolution represents the first declination of a healthcare company under the department-wide CEP, signaling DOJ’s willingness to follow through on the policy’s promise of meaningful incentives for self-reporting companies. It is also significant that this resolution comes on the heels of the DOJ’s recent healthcare fraud takedown, where the DOJ charged schemes involving more than $6.5 billion in alleged fraud.

Practical Takeaways for Healthcare Companies

The Campus Eye resolution underscores the importance of:

• Early Internal Assessment: Timely evaluation of allegations is critical, particularly where the DOJ may learn of the conduct through other channels, especially whistleblowers. Companies should ensure they can quickly assess internal reports and determine whether a disclosure is warranted.
• Acquisitions and Diligence: Though the private equity firm that purchased Campus Eye was not charged in relation to DiDonato’s scheme, diligence—both before and after an acquisition is complete—will be paramount when acquiring healthcare companies.
• Accountability Measures: The DOJ continues to emphasize individual accountability and expects companies to take appropriate disciplinary action. A corporate declination does not shield individuals from prosecution. DiDonato’s parallel indictment demonstrates that the DOJ will continue to pursue culpable executives—and lean on a company’s cooperation and production of evidence to make those cases.
• Demonstrating Tangible Remediation: The DOJ evaluated Campus Eye’s remediation efforts including policy revisions, risk assessments, new compliance hires, and training, as key factors supporting the declination.
• Maintain Robust Compliance Programs: Companies should invest in risk assessments, monitoring systems, training, and compliance staffing as an ongoing priority—not a reactive measure deployed after misconduct surfaces. This compliance program should include heightened attention to preservation practices.

Conclusion

This declination gives shape to the DOJ’s intention of encouraging companies to proactively cooperate and self-report misconduct by offering lenient outcomes.

But the decision to disclose misconduct remains complicated and risky. Early consultation with counsel following internal allegations or discovery of potential wrongdoing remains essential to navigating the DOJ’s expectations, protecting the company, and mitigating enforcement risk.

Ballard Spahr’s White Collar Defense and Investigations Group advises clients across industries on DOJ priorities, internal investigations, and enforcement risk. We assist companies in evaluating compliance frameworks, preparing for potential disclosures, and responding to government inquiries. Please contact us if we can support your organization in navigating this evolving enforcement landscape.

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