3244 New Exclusions Added to the LEIE in 2017

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its second Semiannual Report to Congress for 2017. The report summarized the OIG’s achievements between April and September of 2017, which included estimated savings, criminal actions, civil and administrative settlements, civil judgments, and administrative actions. The OIG also reported the exclusion of 1,822 individuals and entities from participation in federal health care programs during the semiannual reporting period. All exclusions were added to the OIG’s List of Excluded Individuals/Entities (LEIE) database, against which healthcare organizations must screen their employees, physicians, medical staff, vendors, and contractors.

For several years, Tom Herrmann, JD, was responsible for the imposition of civil monetary penalties (CMPs) on health care providers and entities, and the determination of federal health care program exclusions. He explained that Congress has delegated the authority to impose CMPs and assessments to the OIG. Additionally, the OIG has the authority to exclude health care providers and others that have engaged in defined wrongdoing. Most of the OIG’s exclusions involve individuals or entities that have engaged in crimes against HHS programs. However, about one-third of such actions arise from civil and administrative actions. Also, many sanctions were the result of state-level Medicaid Fraud Control Unit actions. The effect of an OIG exclusion is that no payment may be made for any item or service furnished by the excluded individual or entity, or directed or prescribed by an excluded physician. Any claim involving even a portion of services or items from, or directed or prescribed by, an excluded party may be considered improper, false, and possibly fraudulent. Mr. Herrmann further noted that nearly all appeals of program exclusion or CMPs are upheld by an HHS Administrative Law Judge (ALJ), the HHS Departmental Appeals Board (DAB), or federal courts. As such, he warns that it is absolutely essential to have ongoing sanction screening of anyone engaged by a healthcare organization.

Jillian Bower Concepcion, MPA, CHC, CHPC, has assisted many clients in meeting their sanction-screening obligations through the Compliance Resource Center. She notes that the Centers for Medicare and Medicaid Services (CMS) has been very aggressive in calling for sanction screening against not only the LEIE, but also the Debarments posted by the General Services Administration (GSA) and state Medicaid databases. CMS has pressured state Medicaid directors to establish exclusion databases and mandate monthly screening of their enrolled providers if they have not already done so. Since then, 40 states have moved to comply with this CMS direction, with more on the way. This has greatly increased the sanction-screening burden for the compliance and human resources departments of healthcare organizations. Procurement is also affected by the number of vendors and contractors that must be screened. Additionally, medical credentialing must involve sanction screening in its determination of staff privileges. To meet sanction screening mandates, it is almost a necessity to use a vendor search engine tool. This saves providers the trouble of downloading a multitude of sanctions databases and developing their own search engine. Using a vendor for this purpose is a step in the right direction; however, the bulk of the work remains with the organization because it must conduct the actual screening and resolve potential “hits.” Altogether, this can be a considerable effort, and many organizations must dedicate one or many employees to meet all of these obligations. As a result, many organizations choose to outsource the entire process, including verification and certification of screening results, to a vendor.

Sanction-Screening Tips for Compliance Officers

1. Ensure periodic sanction screening of employees, medical staff, contractors, and vendors against the LEIE, at the time of engagement and annually thereafter. An individual or entity that passes an initial screening may be sanctioned by government entities at a later time.
2. Maintain a complete record of sanction screening to evidence that the organization has met its mandates. Individuals responsible for sanction screening should attest to the results, each time screening occurs. If using a vendor to conduct the sanction screening on behalf of the organization, the vendor should provide a full certified report each time it performs their service.
3. Develop a compliance policy or application that requires individuals or entities to attest that they have not been, nor are they now, the subject of an investigation by any duly authorized regulatory or enforcement agency.  The attestation should be a condition of employment and a requisite for gaining staff privileges or securing an engagement with the organization. Organizations should also require employees, medical staff, or vendors to promptly report any notice of investigation that involves them.
4. Ensure that state Medicaid screening requirements are met, in addition to checking the LEIE. For organizations that cross state lines, it is particularly important to ensure compliance with varying state sanction screening mandates.
5. Verify that health care professionals are duly licensed and not under any restrictions. This is critical to the credentialing process, as most exclusions in the LEIE arise from another underlying court, state agency, or licensure board action. Engaging or giving staff privileges to individuals whose licenses are restricted may constitute violation of CMS’s Conditions of Participation.
6. Educate and inform management and employees of their obligation to promptly report any notification of an adverse action by any duly authorized regulatory or enforcement agency.  The organization should implement policies to reinforce this.
7. Consider using a vendor tool to assist in sanction screening, but compare services and costs to avoid unnecessary expenditures. Also, consider the costs and benefits of outsourcing the entire process to a sanction screening vendor.

Do You Need Help With Your Healthcare Compliance Program?

Strategic Management Services, along with Compliance Resource Center, have years of experience creating, reviewing, and monitoring compliance programs, as well as providing tools to support healthcare compliance needs. If you have questions about the effectiveness of your compliance program or any other compliance concerns, contact us online or get in touch with an expert at (703) 683-9600.