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Friday, May 8, 2026

COVID-19: A Roadmap to Fraud Investigations: Office of Inspector General Targets Labs for Billing COVID-19 Add-On Tests - JD Supra

Introduction

On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high billing for additional tests alongside COVID-19 tests.1 This examination of laboratory billing practices by HHS-OIG and subsequent review by the Centers for Medicare and Medicaid Services (CMS) marks the start of another significant wave of COVID-19 and Public Health Emergency (PHE) related government audits.2

This article will provide an overview of the Report and set forth general best practices for laboratories, including tips for conducting self-auditing.

HHS-OIG’s December 2022 Report

To conduct its review of potential fraud, waste, or abuse associated with laboratory billing practices during the PHE, HHS-OIG analyzed data from Medicare Part B claims for COVID-19 tests billed alongside add-on tests from February through December 2020.3 Specifically, HHS-OIG narrowed its focus to “outlier” labs—laboratories that exceed the thresholds for one or both of the following measures:

  1. Laboratories where a high proportion of the total number of tests were add-on tests; or
  2. Laboratories where a high proportion of the total payment resulted from add-on tests.4

The Report defined “add-on tests” as one of the following diagnostic tests that were billed simultaneously with COVID-19 tests:

  • Individual Respiratory Tests (IRTs);
  • Respiratory Pathogen Panels...


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