US HHS OIG and HCCA Release Compliance Program Effectiveness Resource Guide

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide on March 27, 2017 (“the Guide). The Guide was created by the HCCA-OIG Compliance Effectiveness Roundtable which convened in Washington, D.C., in January 2017 to explore ways to evaluate a corporate compliance program. 

The Guide discusses seven elements of an effective compliance program and how to measure them. The seven elements addressed in the Guide are as follows:

1. Standards, Policies, and Procedures, which includes conducting periodic reviews of policies, procedures, and controls;
2. Compliance Program Administration, including maintenance of a compliance budget, as well as maintaining knowledge of current regulatory changes;
3. Screening and Evaluation of Employees, Physicians, Vendors and other Agents, including assuring the inclusion of compliance obligations in all job descriptions, and verifying that background checks are conducted in accordance with applicable rules and laws;
4. Communication, Education, and Training on Compliance Issues, which includes dissemination of regulatory compliance materials and assuring that compliance training occurs;
5. Monitoring, Auditing, and Internal Reporting Systems, which encompasses conducting organizational risk assessments and compliance audits, and recognizing the need for attorney consultation in the auditing process;
6. Discipline for Non-Compliance, which includes comprehensive recommendations for disciplinary action when noncompliance within the organization is confirmed; and
7. Investigations and Remedial Measures, including monitoring the effectiveness of corrective action plans in response to noncompliance.

According to the Guide, the list of elements above is meant “to give health care organizations as many ideas as possible, be broad enough to help any type of organization, and let the organization choose which ones best suit its needs.

The Certified Healthcare Compliance (CHC) Candidate Handbook (“the Handbook) served as a primary resource for the development of the Guide. The Handbook addresses the process for becoming CHC certified. Being CHC certified means possessing a strong knowledge of the regulations and compliance processes that are prevalent in the healthcare industry, as well as the ability to understand and address the legal obligations of an organization via effective compliance programs.

The Guide emphasizes that organizations are not expected to adopt all, or even a large number, of its suggestions at any given time. Rather, the Guide encourages organizations to select measures that suit the needs of their specific organization, as well as consider available resources and risks that confront the organization. Based on these, the organization can better define what their compliance program needs will be going forward.

However, it must be noted that in the State of New York, providers that are subject to the mandatory compliance program requirements in Social Services Law § 363-d and 18 N.Y.C.R.R. Part 521 are required to adhere to all of the requirements found therein, and must also comply with the related guidance available on the New York State Office of the Medicaid Inspector General’s website.

For more information about the contents of the Resource Guide, please contact David R. Ross, Esq. or Mary T. Connolly, Esq.

David R. Ross is a Shareholder of the firm. Prior to joining the firm, and under former Governors Pataki and Spitzer, Mr. Ross served as the Acting Medicaid Inspector General for New York State. He also served as General Counsel, Deputy Medicaid Inspector General and Director of Audits and Investigations for the Office of the Medicaid Inspector General. Prior to his service at the Office of the Medicaid Inspector General, Mr. Ross held several positions at the New York State Office of Alcoholism and Substance Abuse Services (OASAS), including Acting General Counsel, Deputy Counsel, and Associate Counsel. Mr. Ross handles Medicaid compliance matters of all kinds, as well as both Medicare and Medicaid audits and investigations for providers of all types and sizes. He can be reached at (518) 462-5601 or via e-mail at dross@oalaw.com.

Mary T. Connolly is an Associate of the firm and contributed to this article.  Her primary practice areas include health law and litigation. She can be reached at (518) 462-5601 or via e-mail at mconnolly@oalaw.com.