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  4. DOJ’s First Healthcare Declination Under the Corporate Enforcement Policy — and What It Signals for Compliance Priorities
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DOJ’s First Healthcare Declination Under the Corporate Enforcement Policy — and What It Signals for Compliance Priorities

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Aug 4 2026

On July 29, 2026, the U.S. Department of Justice (DOJ) announced its first declination of a health care company under DOJ’s March 2026 Corporate Enforcement Policy (CEP), which applies across corporate criminal matters.  DOJ closed its investigation into Campus Eye Management Holdings LLC and its wholly owned subsidiary, Campus Eye Management LLC (together, Campus Eye), arising from an alleged scheme involving Medicare billing for medically unnecessary diagnostic tests and kickbacks to referring physicians, while simultaneously charging the company’s founder and former chief executive officer based on the same underlying conduct.

The Campus Eye resolution provides an early example of how healthcare companies may mitigate corporate enforcement risk under the CEP.  At the same time, the matter underscores DOJ’s continued emphasis on individual accountability and its broader focus on protecting federally funded healthcare and other government benefit programs from fraud. 

The Allegations 

DOJ alleged that, from approximately 2015 through March 2023, E. Bruce DiDonato, Campus Eye’s founder and former CEO, engaged in a scheme to bill Medicare and other insurers for duplicative or medically unnecessary diagnostic tests and to pay kickbacks to ophthalmologists in exchange for patient referrals.  DOJ alleged that patients for certain eye surgeries were referred and subjected to diagnostic testing that either duplicated testing previously performed or was unnecessary for the relevant surgical procedures. 

DOJ further alleged that the kickback arrangements were concealed through purported consulting agreements that characterized the payments as monthly consulting fees, when in reality the payments allegedly were calculated based on a percentage of Medicare reimbursements generated through the referrals. 

According to DOJ, the alleged conduct resulted in approximately $3.4 million in fraudulent claims submitted to Medicare, of which Medicare paid approximately $1 million.  DOJ also alleged that DiDonato marketed and sold Campus Eye to private equity investors at a valuation that reflected, at least in part, revenues generated through the alleged misconduct. 

Declination Pursuant to CEP & Individual Prosecution

As we have previously discussed, DOJ introduced a department-wide Corporate Enforcement Policy in March 2026 to encourage the voluntary self-disclosure of criminal misconduct, cooperation, and remediation, while promoting consistent treatment across corporate criminal matters. 

Under the CEP, a company may be eligible for a declination where it: (i) voluntarily self-discloses misconduct; (ii) fully cooperates with DOJ’s investigation, including by identifying individuals involved in or responsible for the misconduct; (iii) timely and appropriately remediates the misconduct; and (iv) does not present the policy’s identified aggravating circumstances.  

In announcing the declination, DOJ concluded that Campus Eye satisfied these requirements.  DOJ highlighted several factors supporting that determination, including the company’s voluntary self-disclosure, proactive cooperation, remediation efforts, and agreement to continue assisting ongoing investigations and prosecutions. More specifically, DOJ noted that Campus Eye: 

  • conducted an internal review and provided relevant facts concerning the misconduct and individuals involved;
  • retrieved and analyzed historical data relating to affected beneficiaries and insurers;
  • enhanced its compliance program through ongoing risk assessments and monitoring, the addition of compliance personnel, and targeted compliance training;
  • agreed to disgorge ill-gotten gains and compensate victims; and
  • committed to continuing cooperation, including by providing information and making relevant personnel available for interviews and testimony. 

The resolution also provides insight into DOJ's approach to disgorgement.  DOJ stated that Medicare and other insurers paid approximately $3.7 million for duplicative and medically unnecessary diagnostic tests procured through the alleged kickback arrangements.  However, after conducting an independent inability-to-pay analysis with the assistance of a forensic accounting expert, DOJ concluded that requiring payment of the full amount would “substantially threaten the continued viability” of the Campus Eye entities.  Accordingly, DOJ accepted a $1 million disgorgement payment in victim compensation.

The resolution therefore provides a recent example of DOJ’s willingness, in appropriate circumstances, to apply its inability-to-pay guidance and analytical framework when determining the financial terms of a corporate resolution.

Separately, DOJ announced a seven-count indictment against DiDonato.  The pairing of a corporate declination with charges against the individual allegedly responsible for the misconduct is consistent with DOJ’s longstanding emphasis on individual accountability in corporate enforcement matters.[1]  

The Campus Eye resolution provides an early indication of how DOJ may apply the revised CEP where a company voluntarily discloses misconduct, provides substantial cooperation, undertakes meaningful remediation, and demonstrates an ability to separate itself from the individuals allegedly responsible for the misconduct.

Key Takeaways

The Campus Eye resolution is unlikely to be a one-off event. The Trump Administration has repeatedly identified fraud involving federal programs and government spending as a significant enforcement priority. Consistent with that focus, DOJ and its enforcement partners have continued to devote substantial resources to healthcare fraud enforcement, including through the 2026 National Health Care Fraud Takedown, which resulted in charges against hundreds of defendants in connection with alleged fraud schemes involving billions of dollars. 

Against that backdrop, the Campus Eye declination highlights several practical compliance considerations for healthcare companies and other organizations operating in highly regulated industries: 

  • Robust Policies and Controls: companies should consider maintaining risk-based controls tailored to their business model and regulatory risk profile; depending on the nature of the business, those controls may address referral relationships, consulting and compensation arrangements, discounting and rebate practices, marketing activities, and interactions with healthcare professional and government program beneficiaries.
  • Effective Compliance Programs: ongoing monitoring, auditing, and periodic risk assessments remain important tools for identifying and addressing potential compliance concerns before they develop into more significant legal or regulatory issues.
  • Targeted Compliance Training: companies should consider providing periodic, risk-based training to personnel operating in higher-risk functions and updating training materials to reflect evolving enforcement priorities and developments under healthcare fraud statutes, anti-kickback laws, anti-bribery laws, and the False Claims Act.
  • Prompt Evaluation of Potential Misconduct: clear procedures for escalating concerns, preserving relevant information, conducting internal reviews, and implementing remedial measures can be critical when potential misconduct is identified. 

Although decisions regarding voluntary self-disclosure, cooperation, and remediation necessarily depend on the specific facts and circumstances, the Campus Eye resolution demonstrates that DOJ continues to offer meaningful incentives under the CEP for companies that voluntarily disclose misconduct, cooperate with government investigations, and undertake appropriate remedial measures.  The matter also provides a recent example of DOJ’s willingness to apply its inability-to-pay framework when assessing the financial terms of a corporate resolution. 
 


[1]              See, e.g., Memorandum of the Head of the Criminal Division, Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime, (May 12, 2025). https://www.justice.gov/criminal/media/1400046/dl?inline

 

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Tags

corporate liabilityinvestigationslife scienceshealthcarerisk mitigationdue diligenceanti-kickbackfcacomplianceusregulatory frameworkwhite-collar defense and corporate crime

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Timothy Howard

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