Chapter 2: Healthcare Compliance Program Fundamentals

Introduction to Healthcare Compliance Program Fundamentals

Effective compliance programs are instrumental to successfully run healthcare organizations that engage their workforce and implement ethical systems that contribute and provide patient care and services consistent with healthcare laws, rules, and regulations. The ever-changing regulatory landscape can be daunting. Running the daily operations of an effective program isn’t easy. However, certain basic elements provide a guide to running an effective compliance program and, if monitored and implemented properly, make the job easier and help guide the organization out of harm’s way.

What are the benefits of having an effective compliance program and the risks of not having one? This chapter explains those benefits and risks, and it details the by-now-familiar seven elements that apply to every compliance program. These elements are based on the seven steps outlined in the Federal Sentencing Guidelines issued by the United States Sentencing Commission (USSC). Every effective compliance program should begin with a formal commitment by the governing body/board to these elements. The seven elements drive an organization’s operation and require tailoring to its unique circumstances to ensure that processes are efficient and effective. This chapter also provides a background on government programs and what expectations regulatory enforcement groups have set forth for effective programs, such as the United States Sentencing Commission (USSC), U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG), Department of Justice (DOJ), and the Centers for Medicare & Medicaid Services (CMS), among others.

The compliance profession has evolved and matured over the last 30 years, and much has been learned. This manual provides an overview of the major concepts as a useful refresher for veterans as well as a helpful go-to guide for newcomers. The following sources of information can be consulted on background, regulatory requirements, and reasons for voluntary and mandatory compliance programs. Keep these sources and concepts in mind when updating and maintaining a compliance program.

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