On November 6, 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a revised guide for health care compliance as part of its modernization initiative announced earlier this year. This General Compliance Program Guidance (GCPG) document is the first CPG issued since September 2008. OIG has also announced that in 2024, it will begin publishing CPGs for specific types of health care entities and providers. The first industry-specific CPGs published will be related to managed care and nursing homes.

Although the GCPG is a non-binding document, it provides useful compliance guidance applicable to all individuals and entities in the health care industry. OIG and other government agencies have used past CPGs to structure health care compliance programs and evaluate program effectiveness. The GCPG contains summaries of federal laws relevant to the health care industry, including the Health Insurance Portability and Accountability Act (HIPAA), the Physician Self-Referral Law, the Anti-Kickback Statute (AKS), the Stark Law, and criminal Health Care Fraud Statute. The GCPG offers illustrative examples of prohibited conduct under the aforementioned laws, as well as potential penalties for violating them. It also contains discussion of the new 21^st Century Cures Act, specifically conduct constituting information blocking and associated penalties for same.

Further, the GCPG contains in-depth discussion of elements of a compliance program based on industry feedback and prior enforcement actions. The new compliance program elements outlined in the GCPG include written policies and procedures, training and education, enforcement consequence and incentive standards, and risk assessment, among others.  OIG also acknowledges that smaller health care entities may face financial and staffing constraints that larger entities do not, and offers suggested adaptations for structuring compliance programs for smaller entities.

The attorneys at Nicholson & Eastin, LLP advise health care professionals and health care entities large and small in health care regulatory and compliance matters. If you have questions or concerns regarding the new OIG GCPG, the Anti-Kickback Statute, Stark Law, or any other health care regulatory and compliance matters, please contact us.