Seven Elements of an Effective Compliance Program

Effective healthcare compliance programs are premised on the seven elements of an effective compliance program as outlined in Chapter 8, § 8B2.1 of the Federal Sentencing Guidelines and are the industry standard for any effective compliance program. The seven elements are also the basis of the compliance program guidance documents published by the Department of Health and Human Services Office of Inspector General for a variety of healthcare industry segments.

An effective compliance program will have each of the following elements implemented in a robust manner to help assure the organization apply appropriate measures to operate in an ethical and legal manner:

  • Established Standards and Procedures

  • Compliance Oversight

  • Education and Training

  • Auditing, Monitoring and Report Systems
  • Appropriate Incentives for Compliance and Discipline for Non-Compliance
  • Response and Corrective Action

Evaluate Compliance Program Effectiveness and Identify Gaps

The ability to demonstrate effectiveness of a compliance program is a key priority for healthcare organizations whether it is to the governing body, senior leadership or federal and state regulators. Having an independent objective assessment of the compliance program’s effectiveness is a means of assuring the organization the resources devoted to the compliance program are justified and appropriate when considering the risk profile of the organization. It also provides the entity with information regarding any gaps in the implementation and ongoing functions of the program.

CynergisTek’s Compliance Program Effectiveness Assessment is designed to evaluate the existing compliance program and provide meaningful feedback on the effectiveness of the various elements and any identified gaps. The assessment will also provide input on industry best practices that might be used to improve the program.

CynergisTek will perform an effectiveness assessment of the organization’s compliance program against the seven elements of an effective compliance program as outlined in the Federal Sentencing Guidelines and the Office of Inspector General’s (OIG) compliance program guidance documents. During this process, CynergisTek’s team of consultants will collect pertinent policies, procedures and documentation related to the organization’s compliance program, as well as interview key stakeholders and various workforce members. The team will also provide feedback and, as appropriate, recommendations to improve the effectiveness of the organization’s implementation and ongoing operation of the compliance program under the seven elements.

Post-Assessment Report of Findings and Interactive Workshop

After the assessment is completed, we provide a detailed report of findings, which includes an executive overview and summary, detailed findings and observations, and recommendations for an effective compliance and/or best practice. In addition, an interactive workshop will be conducted with the client’s internal team to facilitate a mutual understanding of the contents of the Reports of Findings, as well as facilitate discussion around the observations and recommendations for next steps.

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