The New “Seventh Element” of Compliance: Screening and Evaluating Employee Suitability!

Co-Founder, Exclusion ScreeningThe recently issued Resource Guide for Measuring Compliance Program Effectiveness, reconfigures the traditional formulation of the “Seven Elements of an Effective Compliance Program by making the “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” an element unto itself – or the new “Seventh Element of Compliance!” The Resource Guide, a product of roundtable discussions by staff members of the Office of Inspector General and compliance professionals and prepared under the auspices of the Health Care Compliance Association (HCCA), serves to once again underscore the critical role of exclusion screening and background checks in compliance

The Importance of the Hiring Process in Health Care

Employee suitability is critically important in healthcare because most of a provider’s operational costs, and almost all of his risks, are directly related to his employees. Whereas most industries are trying to respond to a wide range of risks over which they have little or no forewarning or control (for example, the impact of weather, the availability of supplies or critical equipment, or the failure of equipment they neither own or operate), the majority of risks to health care providers are mostly known and directly related to employee conduct or misconduct (medical malpractice, patient safety, financial fraud, drug diversion, regulatory violations, data and record security, etc.)

The hiring process in healthcare also important because of the value that employees can provide for an organization. “Good” employees enhance the value of organizations; they perceive potential risk and report or fix it, they provide important modeling for new employees, they care for patients in a way that engenders loyalty, they pitch-in, they are honest and show up for work! And so on. Thus, while employees are often the source of loss and cost – they can also represent a sustainable resource that gives an organization a competitive advantage. Viewed in this context, the importance of the hiring process and determining the suitability of employees to a provider’s compliance program becomes clearer still.

Exclusion Screening and Background Checks

An important aspect of determining an applicants overall suitability is “screening” them with Federal and State Exclusion and Sanction Lists. The Resource Guide holds forth that screening should be accomplished upon hire and monthly thereafter, and the importance of thorough screening cannot be overstated as most exclusions are imposed as a result of conduct connected to fraud, patient abuse or neglect, or the sale or abuse of drugs or fraud. Further, regardless of “why” an OIG Exclusion is imposed, persons or entities excluded from Federal Health Care Programs are deemed as a matter of administrative law to “pose unacceptable risks to patient safety and/or to the financial integrity of government programs.”

Exclusion Violation Enforcement

Federal Health Care Programs will not pay for any items or services furnished or provided, directly or indirectly, by an excluded individual or entity. This broad “payment prohibition,” which can extend even to volunteers, renders anyone who is excluded “radioactive“ when it comes to health care. Any claim connected to an excluded person is a potential overpayments, employing or contracting with an excluded person can result in the imposition of civil money penalties, and there have even been False Claims Act cases brought against providers that have used excluded persons.

The OIG signaled that enforcement of exclusion violation was going to be an agency priority in 2013 when it issued its “Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” and revised the “Self-Disclosure Protocol.” Since that time, it has created a special unit tasked with exclusion enforcement as a priority and sought to expand its exclusion authority on several occasions.


The risks and benefits associated with the hiring process are significant; a fact emphasized all the more by the addition of “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” as the new 7th Element for Evaluating the Effectiveness of Compliance Plans. Providers are urged to do thorough screening as part of their hiring process and to take all possible actions toward ensuring a positive work force, and to avail themselves of the assistance of reputable vendors to assist them in this process.

About the Author
Paul Weidenfeld is a long time health care lawyer who has specialized in litigation arising out or, or relating to healthcare fraud and the False Claims Act. A former federal prosecutor and National Health Care Fraud Coordinator for the Department of Justice, Paul is a frequent speaker who has earned recognition both as a Federal Prosecutor and as a member of the private bar.  Paul is also a co-founder of Exclusion Screening, LLC, a company that offers providers a simple, cost effective way to meet their exclusion screening obligations.