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Private Payor Laboratory Audits

During the COVID-19 crisis, many audits by private payors had been paused, but as of the last week, it seems that private payors have resumed auditing. Specifically, Wachler & Associates is aware of private payers initiating audits of laboratories. The laboratories being audited are seemingly ones doing COVID-19 GenX tests, but all laboratories doing any type of COVID-19 test should still be on notice of potential audits coming.

In addition to requesting information regarding the COVID-19 tests, the private payors have also requested a large volume of other materials in these audits. These other materials have included: Copies of CLIA certificates, CMS-116 Applications, lists of testing equipment, invoices, lists of reference labs, shipment logs, credentials for all laboratory staff, lists of daily test volume performed onsite and sent out, hours of operation, specimen processing policies, proficiency test reports, patient service center permits, and emergency use authorizations. These materials being requested go above and beyond what would normally be requested in an audit prior to the COVID-19 crisis.

Laboratories, specifically ones that have performed COVID-19 testing, should begin to review their own records for the above-listed materials in the event an audit occurs. For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in audits. Please contact Wachler & Associates if your facility has recently gotten notice of an audit, or if your facility would like to implement a compliance plan. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or

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