Valuable OIG compliance advice for new healthcare entrants

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In November 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the General Compliance Program Guidance (GCPG). The GCPG is described as a “reference guide for the health care compliance community and other health care stakeholders.”[1] OIG specifically states the Guidance is not meant to “constitute a model compliance program” or be “one-size-fits-all,” but rather it is intended to set forth voluntary guidelines and compliance tips for all individuals and entities that play a role in the healthcare industry.[2]

The GCPG, however, is not a new concept. Since 1998, OIG has been publishing compliance program guidance documents (CPGs), which are described as “voluntary, nonbinding guidance documents to support health care industry stakeholders in their efforts to self-monitor compliance with applicable laws and program requirements.”[3] These CPGs include guidance aimed at specific stakeholders, such as hospitals, home health agencies, Medicare Advantage organizations, nursing facilities, and pharmaceutical manufacturers.

In response to stakeholder feedback, and as a part of OIG’s modernization efforts, OIG published the GCPG, which addresses all of the following topics: (1) key federal authorities for entities engaged in healthcare business; (2) the seven elements of a compliance program; (3) adaptations for small and large entities; (4) other compliance considerations; and (5) OIG processes and resources.[4] In addition, OIG stated that it will no longer publish updated or new CPGs in the Federal Register, but rather will make all current, updated, and new CPGs available on its website in a more user-friendly and accessible format and with interactive links to relevant resources.[5] Further announced efforts include the publication of industry segment-specific CPGs (ICPGs), which will be tailored to fraud and abuse risk areas, for different participants involved in healthcare industry subsectors or ancillary industry sectors relating to federal healthcare programs.[6] OIG plans to release the ICPGs starting in 2024, and will update them periodically in order to address new areas of risk and provide meaningful guidance.[7]

As further explained subsequently, while the GCPC is voluntary and is not binding on any individual or entity, OIG makes clear that its topics and compliance resources apply to all individuals and entities engaged in the healthcare industry.[8] OIG specifically notes the application of the GCPG, its CPGs, and the forthcoming ICPGs to “new entrants” in the healthcare industry and existing healthcare organizations entering new arenas.[9]

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