Compliance
Conflict of Interest: What You Need to Know
During first quarter, many organizations begin collecting their annual Conflict of Interest campaign responses. The importance of having a solid Conflict of Interest policy—along with proper education and training—cannot be overstated. It is fundamental to a meaningful compliance program.
The need to know leads to the need to respond. Determining each employee’s or associate’s outside interests ensures an organization is not unintentionally put into a position of compromise or conflict of interest.
Avoiding disclosure surprises and establishing controls where potential conflicts arise protects the organization and the individual from reputational and legal risk.
However, managing this at scale requires preparation, planning, and transparent communication.
According to SAI360’s Director of Solutions, Bruno Araujo, some of a company or organization’s top reasons for Conflict of Interest process enhancements or solution considerations may include:
- Evolving Department of Justice (DOJ) and Office of Inspector General (OIG) regulation guidance
- Reputational damage when a company or organization receives negative press
- Increased scrutiny from stakeholders, including investors and regulatory bodies, which may lead to financial penalties or sanctions
- Social media risks from problematic Tweets or LinkedIn posts
- The need to replace outdated manual processes
Conflict of Interest Keeps Many Up at Night
The Conflict of Interest process is complex. It involves many people working across separate roles—whether disclosers, administrators, reviewers, or committee members—to address organizationally critical situations together.
Having a robust process increases organization-wide awareness about what defines Conflict of Interest situations. Managing a Conflict of Interest effectively and efficiently demands capturing and recording information. For example, perhaps a Board member also works for a competitor, which will require compensating control. However, this individual is unaware documentation of outside professional relationships is necessary. Here, documentation is imperative.
Addressing Conflict of Interest head-on also requires maturing your education processes. And using non-abrasive language to encourage versus dissuade people to declare outside interests. Actions like these will both drive documentation and put the right kind of guardrails in place.
There is indeed no shortage of hidden or overlooked Conflict of Interest audit concerns, such as holding infrequent investigator trainings, failing to post policies on a company website, or not disclosing a certain relationship.
A few common Conflict of Interest questions you may be struggling with include:
- For what reasons do we put ourselves through this each year? Why?
- Should we expand this to other individuals we are not now working with? Why or why not?
- Does everyone clearly know what to disclose? Where are there gaps?
- Is there a better way to get this work done? How do we get there?
Why is there uneasiness surrounding Conflict of Interest campaigns? Often, it is because many people lack an understanding of what types of relationships need to be disclosed. Others have yet to act in accordance with organizational expectations. Additionally, dealing with Conflict of Interest concerns is stressful. After all, this work involves potential compromise of someone’s judgment, purchasing decisions, ability to work, and so on. Of course, further complicating matters are when patient care, patient safety, or patient well-being become jeopardized as a result.
The Importance of OIG Guidelines
In recent years, the Department of Justice has emphasized the importance of proactive conflict of interest management, pushing companies to adopt more stringent policies to avoid legal entanglements and ensure compliance. Understanding the personal and professional relationships individuals have with your organization and outside your organization is not just a good idea. It is a necessity. Some reasons include:
- Providers are required to disclose potential conflicts, particularly around financial interests, to meet several program integrity requirements of federal programs such as Medicare
- Stark Law compliance
- In a research setting, where grants and funding are both critical and subject to stringent scientific and ethical review, it is important to know about researchers’ outside engagements, such as with pharmaceutical companies. This is especially true when relationships overlap with the research subject being completed.
- NIH regulations
- Adherence to your policies
- Adherence to your own State requirements
- When addressing reasons like these, many ask the “newspaper test” question: If the media discloses a relationship, how comfortable will you be with the published story?
For example, the Stark Law prohibits physicians (with some exceptions) from referring patients to get a designated health service like radiology or physical therapy—if this entity is an immediate family member or a financial partner. Therefore, organizations must consider what to do next should this prohibition, or any other, be violated. And if brand reputation and trust among consumers and clients could decline as a result.
The Next Phase
Your organization may soon become overwhelmed when working to reduce the burden of collecting, reviewing, responding, and managing disclosures. This is particularly true if you are relying on manually created spreadsheets, forms, and emails.
It is administratively burdensome to send surveys, gather timely responses, chase down those that have not yet disclosed, log and update spreadsheets, and route agreements or management plans through an email process. Along the way, key items can unintentionally slip through the cracks.
Software Drives Success
For an organization’s program to be successful, it needs to have a process for three workstreams of disclosure:
- A new hire or an individual you are just beginning to build a relationship with
- Annually for everyone in a campaign, preferably tied to training on what to disclose and your policy, and
- Ad-Hoc so that during the year, individuals can disclose new relationships and update previously reported ones
Thankfully, the process is becoming more technologically driven versus human-driven. This removes the likelihood of error and increases efficiency via automation. Technology specifically allows for seamless integration in the flow of learning or training and policy attestation. It also allows for automated workflows so those who need to be aware of an issue are made aware. And they have an appropriate chain of decision flow when responding.
Technology can also provide evidence that a solid process is in place. Importantly, OIG will seek evidence of this process and want to know if you are capturing and mitigating risks to prove compliance evidence as needed. As regulatory expectations rise, leveraging AI-driven compliance solutions can further enhance the detection of potential conflicts by automatically flagging high-risk relationships based on a company’s historical data.
Some helpful software features include:
- An option to carry forward previous declarations
- Branching logic to make form completion easier for individuals
- Single Sign-On (SSO) for easy access
- Seamless integration with Policy Management, OIG compliance management, and other important aspects of a compliance program
- Automatic reminders with escalations to supervisors
- The ability to report out end-of-campaign that you have met requirements and can analyze effectiveness
Creation and management plans can do much of the heavy lifting via automation, nudges, and tracking to flag issues as they demand attention.
For example, a technology solution might offer SSO support to streamline disclosure submissions and access. Smart forms with branching logic may make live-time adjustments about various responses. Applicable data can transition—pre-filled—from older submissions easily. And the right teams can become aware of real-time disclosure review needs.
Software can also assist with understanding legal obligations and managing the policy needs that are necessary to comply. This includes bylaws, OIG requirements, state-wide rules, Medicare rules, Board of Director conflicts, committee policies, and regulations.
Getting Up To Speed
Inappropriate business relationships are now common media headline mentions. The primary culprit is often reputational. For example, when someone fails to understand regulations and rules, they may choose to make assumptions that do not serve an organization.
Information is available to address knowledge gaps. Here are four ways:
- OIG published enforcement actions and trends. This way, each year’s annual process improves with the lessons learned in the industry over the prior year. Regular, scheduled assessment of ethics policies, especially in disclosing potential conflicts of interest.
- Commercially available and professionally written training programs
- Review of Open Payments data provides transparency to your organization (and the public) about payments to physicians
- The recent addition of other healthcare providers to the Open Payments Data has only expanded available information that can be related to your organization
Final Thoughts
During your annual Conflict of Interest campaign, identify ways to refine and improve through technology to prevent human error or omission. Capture pain points throughout the process. As you tie a bow on your Conflict of Interest campaign, retrospectively analyze your process, data, and tools. Determine what worked well and what needs improvement.
Prioritizing Conflict of Interest education and awareness will only improve organizational processes and expectations, ensure sound judgment, promote a positive workplace culture, help meet legal requirements, and improve management decisions, systems, and thresholds.
Be prepared to be both successful and at ease. Know the consequences and seek help when you need it.
If you are ready to add automation and reduce administrative tasks, we have purpose-built software to solve your pain points. For more information:
