The Department of Health and Human Services recently issued an important new compliance guide, called Measuring Compliance Program Effectiveness: A Resource Guide. The Guide is a combined effort of HHS’s Office of Inspector General and the Health Care Compliance Association and provides guidance on evaluating compliance program effectiveness based on the input of 40 compliance professionals and OIG staff.
For decades, the OIG has instructed health care providers to implement effective compliance programs and has issued voluntary compliance guidance for specific types of health care entities, including hospitals; home health agencies; third-party medical billing companies; the durable medical equipment, prosthetics, orthotics and supply industry; Medicare+Choice (now Medicare Advantage) organizations; individual and small group physician practices; nursing homes; hospices; clinical laboratories; ambulance service providers; and pharmaceutical manufacturers. Section 6401(a)(7) of the Affordable Care Act requires most providers and suppliers to establish compliance plans as a condition of enrollment in Medicare, Medicaid and the Children’s Health Insurance Program, although specific implementing regulations and implementation dates have not yet been issued for most types of providers1. The Guide is noteworthy for being one of the OIG’s only resources specifically focused on practical ways to measure the effectiveness of compliance programs.
The Guide provides an extensive and extremely detailed list of over 400 practical ways to assess whether a compliance program is effectively meeting the seven elements of a compliance program, which are described in the Guide as: (1) standards, policies, and procedures; (2) compliance program administration; (3) screening and evaluation of employees, physicians, vendors, and other agents; (4) communication, education, and training on compliance issues; (5) monitoring, auditing, and internal reporting systems; (6) discipline for non-compliance; and (7) investigations and remedial measures.2 Each element is subdivided into numerous categories, and then organized by program components relating to “what to measure” and corresponding suggestions on “how to measure” effective implementation of each component.
*This alert was originally posted on Arent Fox's Health Care Counsel blog. To read this alert in its entirety, please click here.
2. The voluntary compliance program guidance previously issued by the OIG describe the seven required elements of a compliance program somewhat differently: (1) implementing written policies and procedures; (2) designating a compliance officer and compliance committee; (3) conducting effective training and education; (4) developing effective lines of communication, such as a hotline; (5) conducting internal monitoring and auditing; (6) enforcing standards through well-publicized disciplinary guidelines; and (7) responding promptly to detected problems and undertaking corrective action. See, e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers. One noteworthy difference is that the Guide devotes an entire section, and thus increased emphasis, to the screening and evaluation of employees, physicians, vendors, and other agents. ↩