On November 6, 2023, the OIG released its New General Compliance Program Guidance (GCPG). The GCPG is intended to serve as a voluntary reference guide for the health care compliance community and other healthcare stakeholders discussing general compliance risks and compliance programs. The GCPG addresses applicable federal healthcare laws, the “seven elements” of a compliance program, adaptions for small and large entities, and other compliance considerations. This is off the heels of the DOJ’s updated guidance issued in March 2023 regarding the DOJ’s Evaluation of Corporate Compliance Programs. Further, the OIG announced its intent to publish industry-specific Compliance Program Guidance.
All healthcare providers are required to have a corporate compliance program that is adequate and effective based on the size and scope of the organization. Providers should evaluate their existing corporate compliance programs as it is clear that these are coming under increased scrutiny by the OIG and DOJ – especially where there is a compliance issue under investigation by an auditing agency.
The “OIG General Compliance Program Guidance” (GCPG) refers to a series of documents issued by the Office of Inspector General (OIG) within the United States Department of Health and Human Services (HHS). The OIG develops these guidelines to help various healthcare organizations comply with federal regulations and prevent fraud, waste, and abuse within healthcare programs.
The OIG’s compliance program guidance documents are tailored for different segments of the healthcare industry, including hospitals, nursing homes, third-party billers, and pharmaceutical manufacturers, among others. These documents typically outline the OIG’s recommendations for establishing an effective internal compliance program.
Key elements of an effective compliance program as recommended by the OIG often include:
- Implementing written policies, procedures, and standards of conduct.
- Designating a compliance officer and compliance committee.
- Conducting effective training and education.
- Developing effective lines of communication.
- Conducting internal monitoring and auditing.
- Enforcing standards through well-publicized disciplinary guidelines.
- Responding promptly to detected offenses and undertaking corrective action.
The goal of these programs is to reduce the risk of unethical or illegal activities and to improve the quality of health care services. By following the OIG’s guidance, healthcare organizations can demonstrate their commitment to lawful and ethical business conduct, potentially reducing their liability and risk of facing penalties for non-compliance with healthcare laws and regulations.
It’s important to note that while the OIG provides these guidelines as a resource for healthcare entities, compliance with these guidelines is voluntary. However, implementing a compliance program in line with the OIG’s guidance can significantly benefit healthcare organizations by helping them avoid the pitfalls of non-compliance and fostering a culture of integrity.