Recently, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) published General Compliance Program Guidance (GCPG), a reference guide for healthcare compliance professionals and other healthcare stakeholders. The GCPG is a source of information regarding Federal laws, compliance program infrastructure, OIG resources, and other information that may be helpful in understanding healthcare compliance.
The GCPG covers myriad topics, including the federal anti-kickback statute, the role of the compliance officer, and quality considerations. It also includes links to other websites or the HHS OIG website that may have useful information. Certain terms are uniquely defined in the GCPG and the terms are hyperlinked to their definition for help in understanding. This means that if a user prints part of the GCPG, definitions of the terms may not be included in the printed sections.
The GCPG applies to all individuals and entities within the healthcare industry and addresses key Federal authorities for entities engaged in health care business; the seven elements of a compliance program; adaptations for small and large entities; other compliance considerations; and OIG processes and resources.
Under the section about the federal anti-kickback statute, HHS OIG outlines relevant inquiries to explore and consider when attempting to identify problematic arrangements, such as the nature of the relationship between the parties and the manner in which participants were selected. The document then provides guidance on what to do if a problem is identified. The document also goes in greater detail about civil monetary penalty authorities, the criminal health care fraud statute, and HIPAA Privacy and Security rules.
The third section of the document goes through the seven elements of a successful compliance program: written policies and procedures; compliance leadership and oversight; training and education; effective lines of communication with the compliance officer and disclosure program; consequences and incentives in enforcing standards; risk assessment, auditing, and monitoring; and responding to detected offenses and developing corrective action initiatives.
The fourth section outlines some compliance program adaptations for small and large entities. Included in the section is guidance on how small entities can implement a compliance program that meets the seven elements (even with limited resources) while also providing guidance on how large entities may want to consider the roles of the compliance officer, compliance committee, and the board in developing and monitoring a compliance program that meets the organization’s goals and needs.
What Next?
The GCPG also noted that HHS OIG will no longer publish updated or new compliance program guidance documents in the Federal Register but instead all current, updated, and new compliance program guidance documents will be available online with interactive links to resources.
The GCPG is voluntary and not binding on any individual or entity and HHS OIG uses the word “should” throughout the document to present voluntary and non-binding guidance. Additionally, it is not intended to be one-size-fits-all, completely comprehensive, or all-inclusive of compliance considerations and fraud and abuse risks for every organization. The complete guidance can be downloaded here, or you can elect to download specific individual sections using the same link.
Starting in 2024, HHS OIG will publish industry segment-specific compliance program guidance documents for different types of providers, suppliers, and other healthcare industry participants (and ancillary industries). These guidance documents will be focused on fraud and abuse risk areas for each industry subsector and address compliance measures that participants can take to reduce risks.