Exclusion Monitoring Requirements

While health centers focus on the compliance requirements required to keep/maintain federal designation and funding, both the HRSA Compliance Manual and HRSA Site Visit Protocol also describe the importance of health centers complying with local, state, and other federal requirements. These requirements may be state specific, conditional of insurance payors or CMS requirements. 

One such requirement is regular exclusion monitoring. As health centers receive federal funding through grants or receive payments from CMS, compliance with grant requirements are crucial. This includes ensuring that any employees, contractors, subrecipients or partners that the health center works with are not listed as excluded or disqualified in the General Services Administration’s System for Award Management (SAM) database or the Office of Inspector’s General’s (OIG) exclusion database. 

Health centers should consider the following when incorporating an exclusion monitoring program:

  1. Ensure exclusion monitoring is part of your corporate compliance program. As part of the overall corporate compliance program, ensure that periodic audits are conducted (at least once a year) to determine whether the health center’s written policies and procedures are being followed and are reflective on the standard of practice. For example, if a policy states that exclusion monitoring is completed monthly, then a health center must follow their policies.
  2. Provide employee education and training on exclusion monitoring. Ensure that individuals completing exclusion monitoring understand the reason behind the function, the methods to complete the monitoring, and the reporting of results ensures that this task is completed smoothly. Health Centers should determine which personnel complete this task. Examples may include, but are not limited to, HR staff, procurement and financial staff and compliance officers. If health centers outsource this duty, ensure that exclusion monitoring is completed with due diligence to ensure reliability, accuracy, and compliance with regulatory requirements. 
  3. Maintain robust documentation and recordkeeping. Keep thorough documentation of exclusion monitoring activities which includes monitoring results, actions taken and any follow up tasks required. Work with appropriate staff and, if needed, legal counsel to ensure documentation meets the requirements set forth by the regulatory body.

Best practice is to exclusion monitor your employees, vendors, subrecipients and partners at hire/time of engagement and monthly thereafter.  Utilizing an automated system such as Compliatric significantly reduces the burden of managing this task, and simplifies the reporting process and demonstrating proof of compliance.

As each federal entity may have different regulations, the following sources may be helpful:

  1. **Code of Federal Regulations (CFR):** The CFR, especially Title 2 (Grants and Agreements), contains regulations and guidelines for federal grants, including compliance requirements. You can access these regulations at https://www.ecfr.gov.
  2. **Office of Management and Budget (OMB) Guidelines:** The OMB issues circulars that provide guidance for federal grant management. For non-profit organizations, OMB Circular A-133 (now superseded by 2 CFR Part 200) is particularly relevant. These guidelines detail compliance requirements for federal grants and can be found at https://www.whitehouse.gov/omb.
  3. **General Services Administration (GSA):** The GSA’s website for the System for Award Management (SAM) provides guidance on how to search for excluded or disqualified entities. This is a critical step in grant management to ensure compliance. Visit https://www.sam.gov for more information and to perform searches.


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