Compliance Program Check-Up: OIG’s Seven Elements of Compliance
by Elizabeth “Issie” Karan

For decades, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has provided its perspective on the most important elements to consider when developing and implementing an effective compliance program. Hospitals are required to implement these elements, but any health care entity can benefit from considering them as they update and augment their programs. Please keep in mind that these elements apply to general compliance programs. While they may be useful in ensuring 340B Program compliance, they are intended to apply broadly to all potential areas of risk for health care organizations (e.g., billing, fraud, financial relationships with physicians and other healthcare professionals, etc.).

The OIG believes that the following are important components of compliance:

1. Implementation of written policies, procedures and standards of conduct;
2. Designation of a compliance officer and compliance committee;
3. Conducting effective training and education;
4. Development of effective lines of communication;
5. Conducting internal monitoring and auditing;
6. Enforcement of standards through well-publicized disciplinary guidelines; and
7. Responding promptly to detected offenses and undertaking corrective action.

HTCs should consider whether their compliance programs include these features. For example, is there any open line of communication between all staff and the person in charge of compliance, without interruption from supervisors or other personnel, to enable reporting of any cases of fraud, abuse, or waste? Employees should not be concerned about retaliation for reporting concerns of non-compliance which may necessitate that they can report outside of the managerial chain. Additionally, is the HTC conducting training at regular intervals (likely at least for new employees and annually) to staff and its Board of Directors on potential areas of risk? Training and education demonstrate a proactive approach to compliance and may help avoid problems before they develop.

The Hemophilia Alliance teams stands ready to assist HTCs however possible and answer any questions that you may have regarding high-quality compliance programs.