For decades, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has advised that an effective compliance program begins at the top with the Board of Directors and flows down through the executive leadership and the Compliance Officer to all employees. The OIG and American Health Lawyers Association (AHLA) issued three communications that underscore the duties and responsibilities of the Board in overseeing an organization’s compliance program.
The first was in 2003, “An Integrated Approach to Corporate Compliance: A Resource for Health Care Organization Boards of Directors,” followed in 2007 with “Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors.” The most recent publication, published in 2015, is titled “Practical Guidance for Health Care Governing Boards on Compliance Oversight,” and was developed in conjunction with the OIG, AHLA, Health Care Compliance Association, and the Association of Healthcare Internal Auditors. The Practical Guidance clearly promotes the use of independent compliance experts by Boards and organizations to assist in evidencing an effective Compliance Program. It goes further in stating that compliance experts can assist Boards and management in a variety of ways beyond evaluation of the Compliance Program, including identification of high risk areas, insight into best practices in governance, and consultation on investigation or other substantive matters. It further advises that Boards should have compliance expertise available to make sure they meet all of their fiduciary duties and obligations in overseeing Corporate Compliance, whether or not a Corporate Integrity Agreement (CIA) is involved.
CIA Mandated Use of Health Care Compliance Experts
As noted in the Practical Guidance, the OIG has moved to enhance provisions in CIAs that increase oversight and accountability of those who agree to settlement terms. The Practical Guidance provides almost identical language about Boards’ use of compliance experts as can be found in recent CIAs. The OIG urges Boards to use the advice of experts in fulfilling their duties. Further, the OIG has been very clear that it sometimes requires entities under a CIA to retain an expert to assist the Board in fulfilling its compliance program oversight responsibilities under the CIA.
Any compliance expert engaged by an organization must be independent and certify that he or she will adhere to the independence and objectivity standards of the General Accountability Office’s “Generally Accepted Government Audit Standards” for operational reviews. All compliance experts must have expertise in Federal health care program compliance requirements. Once engaged, the expert is obligated to create a work plan and conduct a review that results in a formal report. The report should focus on the mandated review and recommendations. A copy of the compliance program review report should be included in each Annual Report under the CIA. Copies of materials provided by the compliance expert to the Board and minutes of Board meetings must be made available to the OIG monitor upon request.
Unparalleled Expertise, Qualifications, and Experience
Strategic Management’s health care compliance experts have been assisting health care organizations for over 25 years. We have worked with over 2,000 organizations and have conducted more than 500 compliance program reviews. Strategic Management uses its proprietary Comprehensive Compliance Program Evaluation Protocol©, developed and enhanced over 20 years, which uses over 150 elements to measure compliance program effectiveness; and the Compliance Knowledge Survey© that measures effectiveness through a validated and independently administered survey of employees.
When CIAs began mandating engaging independent compliance experts in Federal health care program compliance requirements, Strategic Management was among the first firms selected by Boards to assist them in meeting this mandate. Having such extensive experience in this area, Strategic Management is able to assist organizations with meeting the important deadlines imposed by CIA in developing timely and credible compliance expert review reports.