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The Renewed Focus on Conflict of Interest in Healthcare

The breadth of risks related to Conflicts of Interest (COI) events continues to grow, driven by additional regulatory oversight.

The DOJ released guidance for prosecutors to assess compliance program effectiveness in June 2021. This guidance includes additional guidelines for COI and disclosure management, foreign and political donations – alongside traditional policy management training, confidential reporting, and third-party risk management.

  • An increase in COI-related audits from the Centers for Medicare & Medicaid Services (CMS), state boards, and insurance agencies.
  • A new component of the Sunshine Act went into effect on January 1, 2022, expanding the definition of "covered recipients" to include mid-level practitioners, physician's assistants (PAs) and other nursing specialists.

The fallout of a misstep around COI can be damaging for any healthcare organization. Alongside reputational harm, there is the potential to violate laws and regulations, including Federal Stark Law regulations, the False Claims Act (FCA), the Anti-Kickback Statute and IRS regulations.

Based on our experience in helping hundreds of hospitals, managed care organizations, clinics, and administrative centers to identify, manage, and minimize COI, disclosure, and related risks, we recommend the following steps: 

  • Revise or create disclosure policies, including COI policies and procedures
  • Educate your staff and business partners on COI
  • Ensure employees know to report suspected COI risks
  • Identify the individuals, functions within HR, Legal, and Compliance to resolve COI-related issues
  • Implement a COI investigation process with qualified compliance officers
  • Keep all COI reports, management plans, processes, and evidence documents in a central manager for easy access and auditing

Talk to experts such as SAI360 about how to create and automate your COI processes. This includes a centralized audit-ready repository, compliance surveys, automated conflict record creation, automated conflict review workflows, and detailed dashboards and reporting to share insight into the workings and success of your COI program.

 


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