The Office of Inspector General (OIG) has broad authority to exclude a healthcare organization from participating in federal healthcare programs (e.g. Medicare, Medicaid). Although exclusions commonly arise from violations of the False Claims Act and Anti-Kickback Statute, there are many other violations that could lead to a permissive exclusion. For instance, the OIG can request immediate access to inspect and copy certain records, and can exclude a healthcare entity for failure to produce the demanded records.[1]

The OIG can demand immediate access to records and data in any medium to ensure compliance with federal healthcare program requirements. You may have to produce records within twenty-four hours from receipt of the OIG request, or sooner if the OIG believes the records are at risk of being altered or destroyed. If you can’t produce the requested records, the OIG can immediately exclude you from participating in federal healthcare programs for at least ninety days.[2]

If you cannot produce the records within the time allotted, you can provide a compelling reason for the delay. However, the OIG decides whether a reason for the delay is truly compelling. The regulations are not clear on what a “compelling reason” is, and responses to comments during the rulemaking process provide only limited context. Fortunately, it appears the OIG does not exclude entities that inadvertently fail to provide access to requested records (e.g. because of a clerical error). However, the OIG is also the sole authority that decides whether a failure to produce records is truly inadvertent.[3]

Because the OIG can request immediate access to records, it’s important to be proactive and maintain a current inventory of the types of records relevant to participation in federal healthcare programs. One way you can prepare to respond to a demand for records on short notice is to create a data map that identifies how records are used, stored, and accessed. You can use the data map to identify relevant records, and determine how you would access and produce those records on short notice. This should help you identify and evaluate any pain points that might arise if you do receive a demand from the OIG.

If you do not already have a data map, consider the following tips as you gauge the accessibility of records...

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Author: Travis Futas, Associate General Counsel at Zasio Enterprises, Inc.