The US Department of Health and Human Services Office of Inspector General (OIG) released its new General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG is designed to serve as a reference guide for the healthcare compliance community and other healthcare stakeholders.

The GCPG addresses applicable federal laws (including the Anti-Kickback Statute, Stark Law, False Claims Act, and HIPAA), the “seven elements” of an effective compliance program and other compliance considerations, and helpful OIG resources, such as Advisory Opinions and Special Fraud Alerts, among other topics.

In keeping with its historical approach, OIG reminds users that the GCPG is voluntary guidance that discusses compliance risks and effective compliance program infrastructures generally; it is not binding on any individual or entity.

Nonetheless, since this is the first compliance program guidance OIG has issued in 15 years, it will garner significant industry attention and may impact healthcare and life sciences sector compliance program assessments and corporate due diligence in connection with mergers and acquisitions, joint ventures, and other collaborations. Additionally, organizations looking to benchmark their compliance programs in connection with the resolutions of healthcare government investigations will undoubtedly be looking to this new GCPG closely.

In April 2023 OIG announced that its compliance program guidances (CPGs) would be updated, including by introducing a new bifurcated format for CPGs—the more general GCPG in addition to industry-specific CPGs. Read this Health Law Scan post for more information on OIG’s overhaul of its CPGs, and contact your Morgan Lewis healthcare lawyer if you have any questions on the new GCPG.