One Compliance Pro’s Regulatory Change Management Process   

amy laufmann regulatory change management

Staying compliant with healthcare regulations is crucial for legal and operational integrity. With new and updated regulations emerging every day, compliance professionals must assess the impact these changes have on the organizations they serve and develop action plans to achieve compliance.   

As a former compliance professional, I’ve worked in a variety of settings from large multi-state health systems to smaller non-profit home health and hospice organizations. Here are the main themes that have guided my career and helped me work through complex regulatory updates.   

Understanding Impact  

Regulations affect various aspects of an organization, from patient care and data privacy to billing practices and staffing requirements. Compliance professionals need to thoroughly understand these impacts to implement effective compliance strategies.   

The process typically involves the following steps:  

  1. Monitoring Regulatory Updates. The first step is to stay informed about new and updated regulations. Compliance professionals use multiple sources to monitor changes, including:  
    • Government Websites for agencies like CMS (Centers for Medicare & Medicaid Services), FDA (Food and Drug Administration), and state health departments.  
    • Industry newsletters, associations, networks, journals, and news sites that report on regulatory changes.  
    • Software solutions like YouCompli® that provide real-time updates, legal analysis, model tools, and procedures for regulatory changes.  
  1. Reviewing the Regulations and Determining Relevance. The next step is evaluating whether those updates require action specific to the services your organization provides. Robust compliance teams track both the services and settings respective to their organization to identify which regulations apply (services, facilities, locations, clinics, etc.).   
  1. Conducting Gap Analysis. Once a new regulation is identified that is relevant, compliance professionals perform a gap analysis to determine where the organization’s current practices fall short. This involves:  
    • Assessing existing policies and procedures to identify areas of non-compliance.  
    • Comparing the new regulatory requirements with the organization’s current practices.  
    • Documenting specific areas that need to be addressed to achieve compliance.  
  1. Risk Assessment. After identifying the gaps, the next step is to evaluate the potential risks associated with non-compliance. This includes:  
    • Assessing potential fines, penalties, and reimbursement issues (financial risks).  
    • Considering how non-compliance could disrupt operations or affect patient care (operational risks).  
    • Evaluating the impact on the organization’s reputation and patient trust (reputational risks).  
  1. Stakeholder Engagement. It’s crucial to understand the broader impact of regulatory changes and to build support for desired compliance initiatives. This involves:  
    • Working with legal, clinical, administrative, IT, and HR departments to gather insights and build a comprehensive compliance plan.  
    • Keeping stakeholders informed about regulatory changes and their implications through meetings, reports, and updates.  

Building a Compliance Plan  

Once professionals thoroughly understand the impact of a change, they can develop a structured plan to achieve compliance. This should include several components:  

  1. Policy and Procedure Updates. Policies may be drafted or updated to meet regulatory requirements. Procedures then can be adjusted to align and ensure consistent implementation across the organization.  
  2. Training and Education. All impacted staff must understand and adhere to new compliance requirements. As such, compliance professionals should design and deliver training sessions tailored to their specific roles and responsibilities. They also should create and distribute manuals, FAQs, e-learning modules, and/or other materials to support ongoing education.  
  3. Implementation Timeline. A realistic timeline for implementing changes is essential for smooth transition and compliance. This should establish clear milestones and deadlines for each phase of the compliance plan and identify/allocate the necessary resources (like personnel, budget, and technology) to achieve them.   
  4. Monitoring and Auditing. Compliance professionals should conduct regular internal and external audits to verify compliance. Utilizing compliance management software can help track compliance activities and identify any deviations. Feedback mechanisms are also helpful, as they enable staff to report issues and the compliance team to provide feedback and corrective actions.  

A clear, structured, and methodical approach to compliance will help professionals navigate regulatory change. The best compliance pros also always seek to improve, so that their organizations are in the best possible position to succeed.   

Amy Laufmann is client success manager at YouCompli. She has 10+ years of experience in healthcare compliance and operations, and is passionate about helping healthcare organizations operate better and deliver better patient outcomes.  

Qualified compliance professionals do the heavy lifting for you, simplifying regulatory change management   

Our in-house team works tirelessly to monitor U.S. regulators, carefully read the regulations in their entirety, and translate the information into simple regulatory intelligence you can use. We deliver model procedures and expert tools that can be used to fulfill your business requirements. Everything is validated by a third-party law firm.  

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