Surge In US Enforcement Actions Shows Focus On Diagnostics

An apparent spike in health care enforcement actions by the US Department of Justice has led to hundreds of millions of dollars in penalties and multiple jail sentences throughout the sector. The DOJ has announced at least 20 device-related cases since mid-September.

The northern facade of the Department of Justice building in Washington, DC.
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Diagnostic firm Genomics Health, a subsidiary of Exact Sciences Corp. , agreed to pay $32.5m to resolve allegations it had filed Medicare claims for some cancer tests. A North Carolina lab owner was sentenced to almost 17 years in prison for billing Medicaid for unnecessary drug tests for Medicaid beneficiaries. And at least 10 practitioners are facing jail time or massive fines for violations of the False Claims Act.

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