Chapter 2: Healthcare Compliance Program Fundamentals

Government Guidance

Several government agencies have issued guidance to aid healthcare organizations in building their compliance programs. The Department of Health & Human Services (HHS) Office of Inspector General (OIG) began issuing voluntary compliance program guidance for a variety of healthcare organizations beginning in 1998. The first compliance program guidance was issued in February 1998 for hospitals. The various compliance program guidance documents are outlined in accordance with the elements the OIG has deemed essential for running an effective program. The OIG guidance has come to be considered the cornerstone of government guidance.

Recently, the Department of Justice (DOJ) revised its Evaluation of Corporate Compliance Programs guidance, first issued in 2017.[5] The guidance is used by federal prosecutors as potential mitigation when evaluating corporate compliance programs and deciding whether to prosecute an organization and what potential penalties and compliance obligations to impose. The revised guidance focuses particularly on whether the organization’s compliance program is well designed in relation to the organization, is being applied in good faith, and works effectively in application and practice by the organization. The guidance offers helpful insight into how the government measures the effectiveness of an organization’s compliance program.

In addition, the following guidance documents and resources listed can help organizations in relation to building their compliance program and identifying and addressing risks that affect their organizations.

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