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Surge In US Enforcement Actions Shows Focus On Diagnostics

 
• By Elizabeth Orr

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.
• Source: Shutterstock

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.

That’s just a sliver of the health care fraud cases announced by the US Department of Justice over the last...

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More from Compliance

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

More from Policy & Regulation

Global Medtech Guidance Tracker: May 2025

 
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More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

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Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.