Establishing a regulatory change management process 

Establishing regulatory change management processes

Repeatability and relationships are key to helping your healthcare organization mitigate risk

You know your healthcare organization’s goals: to save and improve lives while delivering healthy financial returns. As a compliance officer, you’re integral to achieving these goals.

Implementing strong regulatory change management practices can help you contribute to your organization’s success by mitigating risk. But what exactly is regulatory change management? 

In short, it’s about identifying, evaluating, and implementing processes and systems to comply with regulatory changes across your healthcare organization. It’s an ongoing process. And it involves two essential components: strong relationships and repeatable processes.

Develop relationships with departmental and operational leaders 

Healthcare regulations are complex. They frequently change, and new ones are continually introduced, making it tough to keep up.

To effectively manage regulations, a good starting point is to identify and prioritize the highly regulated areas of your organization. 

In hospitals, this generally includes departments like Revenue Cycle, Lab, Physician Services and Pharmacy. These operational areas represent about 70% of the regulations that come out.

Developing relationships with subject matter experts in these areas is critical to shoring up support for compliance activities across the organization. These compliance champions can help make sure you don’t have to do all the heavy lifting as regulations change and new ones come in. 

“Relationship building should be the biggest chunk of where CCOs spend their time,” says Charles Mazer, director of Corporate Compliance at NewYork-Presbyterian. “If people trust you and you have a relationship with them, they immediately believe what you’re saying.” 

He explains how his team approaches nurturing relationships. 

“We have a stakeholder relationship map,” Mazer says. “Everybody in our department has quarterly contacts with anyone who’s VP and above, so that we know what’s going on and if a regulatory change is affecting someone. And our process for regulatory change management is to have a committee that every regulatory change goes through. This gives us a standard process for implementation.” 

Charles Mazer, director of Corporate Compliance NewYork-Presbyterian

Establish repeatable regulatory change management processes 

In addition to strong relationships with operational stakeholders in your organization, process is key. Processes for implementing regulatory changes must be intentional, repeatable, and scalable.

“Rely on your processes,” advises Mazer. “The benefit of having a process is that no matter your size or focus, if you have a process embedded, you’re reducing the regulatory risk your organization faces.”  

Implementing effective regulatory change management processes enables you to: 

  • Know what’s changing and the impact on your organization. This involves three parts. The first is tracking all the necessary regulators so you know what’s changing. Second, know who in your organization is responsible for implementing changes to comply. It’s helpful to have a “regulatory rolodex” of departmental and operational leaders in your organization’s highly regulated areas. Nurturing relationships with these folks will help make sure you have compliance champions to turn to when you need them most. Third, you have to have a good way to know what to change if the regulation is relevant. 
  • Decide if, and how, a change relates to your organization. When a new or updated regulation comes in, you need to decide whether it applies to your organization. Avoid wasting time and resources on changes that don’t affect your organization by having a standard methodology to decide whether a regulation is relevant. 
  • Manage the rollout and accountability of requirements. Once you decide a regulatory change applies to you organization, establish a workflow to manage the work that needs to be done to comply. This means ensuring that all stakeholders who are involved in the process of complying are aware of what they’re supposed to do and when. Make sure all affected departmental and operational leaders are aware of roles, responsibilities, and deadlines.         
  • Verify progress and completion by required dates. Throughout the rollout, track all compliance decisions and activity so that you can verify that required changes were put into effect. Depending on the regulation, you may need to verify that behavior has been changed or verify that a policy has been modified. Whatever you’re verifying, it’s important that you can easily prove how your organization has complied with a change. This way if a regulator has a question, you have a good answer at the ready. 

Repeatable processes are crucial for helping your organization drive better health and business outcomes. Effectively managing regulatory changes enables you to mitigate risk and show the value Compliance delivers to your organization. 

Recently, I moderated a panel at the HCCA’s Annual Compliance Institute to discuss how healthcare compliance officers can effectively manage regulatory change. It was an impactful conversation with three compliance experts: Shawn DeGroot, president of Compliance Vitals; Charles Mazer, director of Corporate Compliance at NewYork-Presbyterian; and Ken Zeko, principal advisor and attorney at Hall Render Advisory Services. 

Our discussion generated useful tips on how compliance officers can establish standard processes and develop influencer skills to help their healthcare organizations mitigate risk. We also explored industry research on compliance professionals’ best practices for lessening organizational risk through regulatory change management.

We’re sharing the takeaways in a white paper, Empowering Compliance Officers to Drive Better Health and Business Outcomes. Download the white paper for insights and guidance on how you can lessen risk and deliver value to your organization through strong regulatory change management.

Empowering Compliance Officers to Drive Better Health and Business Outcomes
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