​In the constantly evolving climate of health care enforcement, maintaining a comprehensive and effective internal compliance program has taken on added significance, especially in the past few years. While detailed coverage of the elements, drafting, and implementation of a hospital compliance program cannot be provided by this article, this overview serves as a broad summary of what hospital leadership and compliance teams should be focusing on as we see the advent of mandatory compliance programs. The resources referenced in this article, along with the assistance of experienced legal counsel, should assist your facility in its review and development of a robust compliance program and related compliance plans, policies, procedures, training, and internal compliance audit functions.

The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services, along with various other federal and state enforcement agencies, have increasingly focused on self-regulation of health care providers’ compliance as one of their top priorities. That increased focus is underscored by Section 6401 of the Patient Protection and Affordable Care Act (ACA), which provides that the implementation of compliance programs by hospitals will soon be mandatory as a condition of enrollment in Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). As often is the case, CMS has not yet been able to provide a firm date when the implementation of hospital compliance programs will be mandatory.  However, a review of the OIG’s annual work plans and its sentencing commission guidelines over the years arguably show that the OIG essentially views compliance programs as already mandatory for hospitals, independent of the conditions of participation in the ACA referenced above.

The various government agencies that oversee and enforce government health care program integrity and compliance provide many valuable resources online. We encourage you to review the available online resources, some of which are listed below, as well as the resources in our recent publication from July 2015,The Health Law Guide to Hospital Operations.

An effective compliance program is essential in today’s enforcement environment and can be a hospital’s most valuable tool in planning for, preventing, and addressing the abundant, and often unpredictable, operational issues confronted each day. As your hospital continues to assess, develop, and ultimately operate its compliance program, the role of legal counsel as a member of the compliance team is critical to ensuring the quality and effectiveness of the processes in place within your organization and addressing compliance-related issues as they arise.