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Recent Compliance Updates & Tips

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During my term as the Department of Health and Human Services (DHHS) Inspector General, I instituted what has become the “List of Excluded Individuals and Entities” (LEIE). The Office of Inspector General (OIG) calls for screening against the LEIE of all individuals and entities engaged in federal health care program business. CMS makes LEIE screening a condition of participation and enrollment. The OIG has a number of administrative sanction authorities by which to add steadily to the LEIE database. In 2014, the OIG reported exclusions of 4,017 individuals and entities from participation in federal health care programs. In the last three years, the OIG added 10,363 exclusions from federally funded health care programs to the LEIE.

OIG Enforcement Authorities

The exclusion enforcement authority was delegated to the OIG to impose Civil Monetary Penalties (CMPs), assessments, and program exclusion on health care providers and others determined to have engaged in defined wrongdoing. The effect of an OIG exclusion is that no payment may be made for any item or service furnished by an excluded individual or entity, or directed or prescribed by an excluded physician. There are “mandatory” and “discretionary” exclusions from participation in Federal health care programs. Mandatory exclusions are required where entities or individuals are convicted of a criminal offense related to Medicare or a state health care program or related to neglect or abuse of patients. Discretionary exclusions are for other types of misconduct, such as license revocation or suspension, exclusion or suspension from another federal or state health care program, provision of unnecessary or substandard services, fraud or kickbacks, and default on a health education loan. Passage of health care reform amended and expanded the existing authority for the OIG to impose CMPs and exclusions. The fact is that most OIG program exclusions, whether mandatory or discretionary, are derivative of a prior official action, whether it was a court conviction or licensure board revocation. As such, in almost all instances where the OIG’s imposition of program exclusion or CMPs is appealed, it is upheld by a DHHS Administrative Law Judge (“ALJ”), the DHHS Departmental Appeals Board (“DAB”), and Federal Courts.

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Practical Tips for LEIE Screening

  1. Ensure periodic sanction screening of employees, medical staff, contractors and vendors against the LEIE and not just at time of engagement. It is not uncommon for individuals to be the subject of an investigation but not yet sanctioned since final actions can take considerable time. An individual may pass a sanction screen at the time of engagement but later have a sanction imposed.
  2. Ensure maintenance of a complete record of sanction screening to evidence compliance with screening mandates. The individual(s) responsible for sanction screening should sign a note of attestation with the screening file each time screening has taken place. If using a vendor to conduct sanction screening on behalf of the organization, the vendor should provide a full certified report each time they perform their service.
  3. To further guard against engaging someone who may pass a sanction screening today, but not later, it is a best practice to develop a compliance policy and applications requiring that, as a condition of employment, gaining staff privileges or engagement, employees attest that they have not been, nor are they now, the subject of an investigation by any duly authorized regulatory or enforcement agency. It is also advisable to add a condition of engagement that employees must promptly report any notice of investigation that involves them.
  4. At CMS urging, nearly half of states have developed their own exclusion database, many of which mandate monthly screenings. Therefore, care should be taken to meet state screening requirements in addition to checking the LEIE. For those organizations that cross state lines, it is particularly important to ensure compliance with all sanction screening mandates that vary from state to state.
  5. Inasmuch as most exclusions in the LEIE arise from another underlying court, state agency or licensure board action, it is critical to verify that health care professionals are duly licensed and not under any restrictions as part of the credentialing process. CMS may consider engaging or giving staff privileges to individuals who are restricted in their license as a violation of the 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. Policies should be implemented to reinforce this.
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