Health Law Highlights

Highlights from OIG’s New Compliance Program Guidance

From Gardner Law:

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released the General Compliance Program Guidance (GCPG) in November 2023, a reference guide for health care compliance. It includes information about Federal laws, compliance program infrastructure, OIG resources, and other useful compliance-related information. 

The GCPG highlights primary sources of governing authority in the health care industry, including the Federal Anti-Kickback Statute and Physician Self-Referral Law. It also discusses the HHS OIG’s exclusion authority and potential civil and criminal implications of non-compliance.

The GCPG outlines seven key elements for an effective compliance program:

  1. Written Policies and Procedures
  2. Compliance Leadership and Oversight
  3. Training and Education
  4. Effective Lines of Communication
  5. Enforcing Standards
  6. Risk Assessment, Auditing, and Monitoring
  7. Responding to Detected Offenses and Developing Corrective Action Initiatives

The HHS OIG emphasizes that these elements are nonbinding recommendations, but they cover mandatory compliance obligations. Therefore, health care stakeholders should use the GCPG to identify and address their compliance duties.

Starting in 2024, the HHS OIG will issue industry segment-specific compliance program guidance and will publish new compliance guidance documents online instead of in the Federal Register. The release of the GCPG is an opportunity for health care stakeholders to audit their compliance programs and ensure they meet HHS OIG standards.