The U.S. Department of Health and Human Services Office of Inspector General (OIG) has issued numerous compliance program guidance documents. These compliance program guidance documents include recommended compliance activities and advisory information. The recommendations are not necessarily mandatory requirements for healthcare providers but instead strongly advised by the OIG. However, there are some exceptions. One such exception is the OIG’s position on sanction screening.
Sanction and exclusion is not advisory, nor a nice to have compliance activity. The OIG makes it clear that healthcare organizations are obligated to screen employees, physicians, vendors and contractors against their List of Excluded Individuals and Entities, known simply as the LEIE. Failing to screen the LEIE can result in all claims and costs associated with that excluded party being viewed as false and fraudulent. As result, the healthcare organization could face significant financial penalties.
This obligation for healthcare organizations began during my watch as the Inspector General. I developed what is now referred to as the LEIE. Since then CMS has included sanction and exclusion screening a condition of payment, as well as a condition of enrollment. Additionally, CMS mandated that state Medicaid directors develop their own sanction and exclusion databases and mandate their enrolled providers to screen the database on a monthly basis. Thirty-six states have already moved to establish their own Medicaid sanction and exclusion list; with many states now mandating monthly screening against the Medicaid list and the LEIE.
Sanction Screening Made SimpleGet Free Quote & Demo
All this increased activity around sanctions and exclusions has greatly increased the burden on compliance officers. It also leads to many questions about best practice and costs. I am frequently asked by compliance officers for best practices and tips to improve their screening process and lower costs. I have compiled my top tips for you to consider.
Analytical Steps To Evaluate Your Sanction and Exclusion Screening Process
- Identify staff who will have the responsibility for controlling the entire process.
- Identity all the federal sanction and exclusion databases that should be screened (e.g. OIG LEIE, GSA SAM, OFAC SDNL, FDA, DEA, etc.)
- Identify the specific state’s that maintain a Medicaid sanction and exclusion databases, and know what is required by those Medicaid programs.
- Determine how frequent you must screen the identified databases (e.g. monthly, quarterly, annually, at time of engagement)
- Identify all business areas involved in screening efforts (e.g. procurement, compliance office, HRM, medical credentialing)
- Assess the level of time and effort spent supporting the screening process by each function and business area.
- Assess and monitor the time and effort spent by those resolving potential “hits.”
- Evaluate how sanction and exclusion screening reports and related documents will be maintained and by who.
- Identify staff assigned to sign off on sanction and exclusion screening reports and results.
- Review policies and procedures that provide guidance on the entire process.
After conducting an evaluation of the current process, consideration may be given to revise the process in a more economical means to accomplish the same or better ends by employing a vendor. There are generally two types of services: (1) subscribe to a tool to conduct sanction and exclusion screening across multiple databases; and (2) outsource the entire process to a vendor.
Today, thousands of healthcare providers rely on vendor search engine tools to carry out sanction and exclusion screenings in-house. It saves time and money from developing their own search engine, as well as maintaining and collecting sanction data on a monthly basis. If you opt to subscribe to a vendor’s tool then the cost should be a fixed rate, which can be easily budgeted. Avoid costs that are calculated on a per search rate; those are difficult to budget and can become costly. Using a vendor’s tool is only a small part of the sanction and exclusion screening burden because the bulk of the screening effort is handled by the organization, including conducting the monthly screenings, resolving potential matches and drafting reports to evidence the screening was done correctly. The alternative approach is to outsource the entire process to a vendor. Vendors are able to:
- Keep all sanctioned data up-to-date
- Continue servicing and improving their search engine technology and capabilities
- Perform the screening as often as needed (preferably monthly)
- Use their own professionally trained staff to resolve potential hits
- Provide a certified report for the record
The cost to using a vendor tool is typically less than what it costs the organization to do the same work without a tool. The same holds true for outsourcing the sanction and exclusion process, which typically is less than what the organization is spending on internal costs, time and resources. Ultimately, no matter how the compliance officers meet this obligation they should undertake analysis of the process to determine their needs and costs.