OIG Releases Compliance Program Update

April 18, 2017 | Compliance Investigations & White Collar | Health Services

On March 27, 2017, the U.S. Office of Inspector General (“OIG”) released a new compliance program guide, Measuring Compliance Program Effectiveness—A Resource Guide (the “Guide”). The Guide was developed by compliance professionals and staff from the U.S. Department of Health and Human Services and OIG, as an effort to help healthcare organizations measure the effectiveness of their compliance programs by providing them with a broad variety of metrics to assess compliance. The Guide was not designed as a generally applicable “checklist” for all compliance programs, but rather as an expansive list of metrics to evaluate the seven elements of a compliance program which healthcare organizations can tailor to fit their individual compliance and operational needs.

Element 1: Standards, Policies, Procedures

The first element of an effective compliance program is having written policies and procedures, including a Code of Conduct, by which employees, vendors and consultants must abide to ensure compliance with applicable laws and regulations. The effectiveness of a healthcare organization’s policies and procedures can be determined by measuring their accessibility, quality, and clarity. For instance, when measuring the accessibility of the policies and procedures, a healthcare organization should look to whether they are easily located by employees via the organization’s website or intranet and whether the employees actually access and review the policies and procedures. With respect to quality, an organization should consider whether its policies and procedures are consistent with industry standards, appropriate for the type of business it conducts, and useful for employees in conducting their jobs effectively. To review the clarity of the policies and procedures, an organization can consider conducting focus groups to determine whether the policies and procedures are written in plain language, are understood by its employees, and whether employees have appropriate means for communicating any questions or clarifications they may have.

 Element 2: Compliance Program Administration

The next element of a compliance program is its administration. For healthcare organizations to properly administer and oversee a compliance program, organizations should develop a compliance plan, designate a compliance officer, and establish a compliance committee. However, it is not enough to merely have a compliance officer and committee in place. Organizations should verify that the administration of their compliance program is truly proactive and robust. For example, when evaluating the effectiveness of the compliance committee, the organization should look to whether the committee is composed of members from appropriate levels of management, and that members are attending and contributing to meetings.

Element 3: Screening and Evaluation of Employees, Physicians, Vendors and Agents

As part of an effective compliance program, healthcare organizations should also routinely screen and evaluate prospective and current employees, vendors, and other third party agents to ensure that they have no conflicts of interests, they are properly licensed and not excluded from any federal or state healthcare programs, and that, when issues arise, there are corrective procedures in place. To ensure that its screening and evaluation process is effective, organizations can review the performance of employees tasked with screening and vetting candidates, and review conflict of interest disclosure forms to ensure that candidates understand what they must disclose and confirm that they are properly disclosing such conflicts.

Element 4:  Communication, Education, and Training on Compliance Issues

The fourth element of an effective compliance program involves the proper training and education of employees, contractors, and agents. Training should be conducted at the onset of any new employment and routinely thereafter, and should be conducted at all levels of the organization. In evaluating the effectiveness of its training and education programs, an organization should review its training materials, and survey its employees to determine whether they believe there is a culture of compliance within the organization and whether compliance issues are being communicated effectively.

Element 5: Monitoring, Auditing, and Internal Reporting Systems

The fifth element involves a healthcare organization’s ability to properly audit and monitor its compliance program by ensuring that it has an effective reporting system, audit process, and corrective action plans for when compliance issues arise. One simple way that an organization can measure the effectiveness of its monitoring and auditing system is by asking employees if they know how to report compliance issues and whether they understand that they would not be subject to retaliation for reporting any issues.

Element 6: Discipline for Non-Compliance

The sixth element of a compliance program involves the enforcement of a healthcare organization’s compliance policies and procedures through disciplinary measures. For a healthcare organization to properly enforce its compliance program, the organization should have a clear policy regarding disciplinary actions which are communicated to and understood by its employees and agents. Disciplinary actions should be consistent, fair and well documented.

Element 7: Investigations and Remedial Measures

The final element of a successful compliance program is how a healthcare organization responds to and corrects compliance issues. Conducting investigations and taking actions to identify, correct, and prevent future compliance issues are the hallmarks of an effective compliance program. As such, healthcare organizations should have clear guidelines for conducting investigations, properly trained staff to conduct the investigations, and the ability to take remedial actions and ascertain the root cause of any compliance issue. Organizations should review their policies, procedures and protocols for conducting investigations, ensure the investigative process is transparent, and review past investigations to certify that the policies procedures and protocols have been followed consistently.

When compliance issues arise within healthcare organizations, they have the potential to cause a great deal of stress and inconvenience, and may result in financial penalties. To prevent such ramifications, all healthcare organizations, whether small physician practices or major hospital systems, should conduct annual reviews of their compliance programs using the metrics set forth in the Guide.

To see the full Guide and for more information regarding effective compliance programs, visit OIG’s website at: https://oig.hhs.gov/compliance/101/index.asp#measuring.

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