The Renewed Focus on Conflicts of Interest in Healthcare

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

Regarding a brief Conflicts of Interest overview, the U.S. Department of Justice (DOJ) updated its guidance in June 2021, introducing stricter expectations for COI and disclosure management, including foreign donations and political contributions, on top of traditional compliance elements like reporting and third-party risk management. Additionally, increased audits from the Centers for Medicare & Medicaid Services (CMS) and state boards are intensifying pressure on healthcare institutions.

A significant development came with the expansion of the Sunshine Act on January 1, 2022, which now requires reporting for mid-level practitioners like physician assistants and nursing specialists. Healthcare organizations must comply with a range of regulations, including the Stark Law, False Claims Act (FCA), and the Anti-Kickback Statute, to avoid serious legal and reputational damage. In response, organizations are advised to revise their COI policies, educate staff, and ensure processes for disclosure and reporting are in place. Leveraging technology to automate COI management and maintain centralized, audit-ready records can enhance compliance efforts and mitigate risks.

More about What’s Happened Prior

The DOJ released guidance for prosecutors to assess compliance program effectiveness in June 2021. The DOJ’s guidance included additional requirements 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.

Additional resources: 

• On-demand webinar: Are You Prepared for Updated 2022 Conflict-of-Interest Regulations?
• Infographic: Ensuring Health Plan Compliance with Federal Regulations

Set up a time to talk with an expert at SAI360 about conflict-of-interest management best practices, supporting technologies and handling COI-related risks.