Practical Advice on Converting Compliance Plans into Compliance Programs.

In its earlier compliance guidance, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) used the term “compliance plan” to refer to an organization’s strategy to detect, address, and prevent ongoing regulatory compliance challenges.  Since then, the OIG has instead used the term “compliance program” to describe these efforts.  Despite this shift in terminology, many professionals in the health care industry continue to refer to compliance programs as “plans” instead of “programs”.  The OIG now uses the term compliance “programs” to emphasize the need for plans to be a living and ongoing part of the organization.  As professionals continue to reference compliance programs as “plans”, they are undermining the scope and significance of these organizational structures.

Compliance experts provide the following observations regarding the conversion of compliance plans into compliance programs:

1. An organization does not have a compliance program until it implements its compliance plan.

• Many organizations have a compliance plan instead of a compliance program. The plan usually consists of a binder containing a written account of what the organization intends for the compliance strategy, along with numerous compliance related form documents.  As a result, the compliance plan is just a physical object instead of an active part of the organization.  In such situations, the organization does not have an actual compliance program; rather, the organization maintains the appearance of having a program in the form of its surface compliance plan.  Organizations should note that a compliance program does not exist until the compliance plan is implemented, reviewed, monitored, and tested for effectiveness.

2. Health care organizations should have a currently functioning compliance program.

• Compliance plans are very common throughout health care organizations. The language in these plans often mimics OIG compliance guidance rhetoric; however, the plans are never actually implemented.  Given that the United States Sentencing Commission, the OIG and the Department of Justice’s compliance program guidance and guidelines have been in existence for some time, organizations should have already translated their compliance plans into operating compliance programs.

3. The inappropriate use of compliance templates can cause significant compliance risk.

• Many organization’s compliance plans often include a description of the intended structure of the program, the role of the Compliance Officer, and a code of conduct (code) that echoes compliance guidance documents. However, taking the structure and converting it into a functioning program that can evidence meeting the objectives requires a significant amount of work.  Further, using improper template codes and compliance policy documents can make the translation process more problematic.  Since these templates are designed for all organizations in the health care sector, they are unlikely to be suitable for any specific organization without additional tailoring.  For example, a code developed for a large hospital system or skilled nursing facility may not work well for a small suburban hospital or clinical lab.  Given the substantial differences among these health care providers, their codes and policies and procedures will also have significant differences.

4. An organization must expend considerable effort to convert a compliance plan into an effective compliance program.

• An organization can certainly benefit from having a compliance plan.  Compliance plans often provide a roadmap to an effective program.  However, the problem arises when an organization tries to embed the plan into the fabric of the organization.  To do so, an organization must understand its operating culture and adapt the OIG compliance guidance to establish an effective program.  The OIG has emphasized that compliance programs are not a one-size-fits-all approach.  Each organization has a unique culture and industry sector.  As a result, each organization must take the OIG’s basic principles and adapt them to apply to their own circumstances.  This translation process requires tremendous effort.