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Compliance Audits and Reviews: A Step-by-Step Guide

In today’s complex regulatory landscape, ensuring compliance with federal and state laws is crucial for healthcare organizations. A well-designed compliance audit and review program can help identify and mitigate risks, prevent non-compliant conduct, and protect the organization from potential penalties and reputational damage.

Best Practices in Compliance

A recent report highlights key recommendations for effective compliance programs:

• Utilize outside resources: Contract tracking mechanisms, rapid response protocols, and independent legal counsel can enhance compliance.
• Formalize compliance processes: Incorporate compliance into annual reviews, employee evaluations, and 360-degree feedback.
• Communicate effectively: Establish multiple channels for reporting concerns, provide training and education, and track progress.
• Implement a compliance management plan: Conduct regular risk assessments, monitor auditing activities, and document everything.

Step-by-Step Guide

Establishing a Compliance Committee

1. Enhance charters, agendas, and minutes to ensure transparency and accountability.

Annual Compliance Education Plan

1. Train all employees within 30 days of hire and annually thereafter.

Communication Strategy

1. Establish multiple channels for reporting concerns, provide training and education, and track progress.

Risk Assessments

1. Identify potential risks and develop strategies to mitigate them.

Audit and Monitoring Program

1. Conduct regular audits, monitor compliance, and document everything.

Practical Considerations

Scope of Review

• Determine the scope of review based on division, department, or organization-wide concerns.

Frequency and Number of Reviews

• Conduct reviews regularly to ensure ongoing compliance.

Criteria for Review

• Establish clear criteria for reviewing specific areas or programs.

Process for Conducting Reviews

• Identify who will conduct reviews (Legal/Compliance, Outside Counsel, or Combination).

Use of Results

• Use review results to suggest process improvements, remediation, and tangible steps.

Best Practices in Compliance

While there is no one-size-fits-all approach to compliance, Katten’s experience highlights key takeaways:

• National healthcare practice with pulse on areas of risk: Representing health systems, hospitals, and life science companies.
• Don’t be the first: Represent clients in internal investigations, government investigations, and qui tam suits.

Questions?

For more information or to schedule a consultation, please contact:

Ethan E. Rii, Esq. Partner Katten Muchin Rosenman LLP ethan.rii@kattenlaw.com