Compliance Program Elements

The Office of the Inspector General believes that every effective compliance program must begin with a formal commitment by the organization’s governing body to include all of the applicable elements listed below. These elements are based on the seven steps of the Federal Sentencing Guidelines. As a first step, a good faith and meaningful commitment on the part of the organization administration, especially the governing body and the CEO, will substantially contribute to a program’s successful implementation. At a minimum, comprehensive compliance programs should include the following seven elements:

(1) The development and distribution of written standards of conduct, as well as written policies and procedures that promote the organization’s commitment to compliance (e.g., by including adherence to compliance as an element in evaluating managers and employees) and that address specific areas of potential noncompliance, such as controlled substances diversion;

(2) The designation of a chief compliance officer and other appropriate bodies, e.g., a corporate compliance committee, charged with the responsibility of operating and monitoring the compliance program, and who report directly to the CEO and the governing body;

(3) The development and implementation of regular, effective education and training programs for all affected employees;

(4) The maintenance of a process, such as a hotline, to receive complaints, and the adoption of procedures to protect the anonymity of complainants and to protect whistleblowers from retaliation;

(5) The development of a system to respond to allegations of improper/ illegal activities and the enforcement of appropriate disciplinary action against employees who have violated internal compliance policies, applicable statutes, regulations or Federal health care program requirements;

(6) The use of audits and/or other evaluation techniques to monitor compliance and assist in the reduction of identified problem area; and;

(7) The investigation and remediation of identified systemic problems and the development of policies addressing the non-employment or retention of sanctioned individuals.