The focus on compliance oversight by organizational leaders and governing boards has increased substantially. The expectations for oversight have been the spotlight of new guidance from OIG and a strongly worded memorandum from the Department of Justice, and those expectations have been set high. The April 2015 collaborative guidance issued by the OIG, the American Health Lawyers Association, the Association of Healthcare Internal Auditors, and the Health Care Compliance Association was intended to be an educational resource for health care organization governing boards in carrying out their compliance obligations. The guidance document provides practical ideas for ensuring the appropriate level of Board involvement and emphasizes the need for a meaningful understanding of compliance.
To achieve the appropriate level of understanding, the guidance recommends having someone with compliance expertise serve as a member of, or a consultant to, the Board. Athena’s partners are well-versed in health care compliance matters and Compliance Program maintenance. We can provide the compliance expertise your Board needs on an ongoing or “as needed” basis. Utilizing an external compliance expert as a Board resource allows the members to independently evaluate risk and the compliance efforts used to address that risk.
Conducting human subjects research is a privilege that comes with its own set of unique compliance requirements. Whether your research compliance program falls under the umbrella of Corporate Compliance or functions independently, continuous oversight of human subjects research requires a great deal of time and expertise. From managing conflicts of interest to auditing the informed consent process to ensuring accurate research billing practices, Athena can help you manage your research compliance obligations. Those involved in conducting research are held to the highest ethical standards. It is important to periodically evaluate your organization’s:
- Protocol submission and IRB review process,
- Conflict of interest management process,
- Documentation practices,
- Policies and procedures,
- Reporting processes and
- Research billing practices.
Whether you are assessing your organization’s overall adherence to the ethical principles and guidelines for the protection of human subjects of research or addressing an identified area of improvement, Athena can help you meeting your research compliance obligations.
Athena Compliance Partners has standing relationships with subject matter experts in the areas of coding and documentation, medical necessity, and statistics. These subject matter experts have a deep knowledge base in their areas of expertise and work with Athena to ensure that your compliance needs are met.