Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing.

These federal investigations can be surprising and confusing for lab executives and workers. They also carry severe repercussions if they discover wrongdoing, mismanagement, or even unintentional mistakes.

Here are some of the most frequently asked questions that Dr. Nick Oberheiden, founding partner of the healthcare fraud defense law firm Oberheiden, P.C., gets in his daily work protecting the rights and interests of healthcare providers and laboratories.

1. Which Federal Laws Apply to Laboratories?

Laboratories have to comply with numerous federal laws. Some of the most important to be aware of are the:

• False Claims Act (31 U.S.C. §§ 3729 – 3733)
• Anti-Kickback Statute (42 U.S.C. § 1320a-7b)
• Physician Self-Referral Law, commonly known as the Stark Law (42 U.S.C. § 1395nn)
• Clinical Laboratories Improvement Act (42 U.S.C. § 263a) and the Clinical Laboratories Improvement Amendments and its regulations (42 CFR 493)

Complying with these federal laws is not always easy. A lab defense lawyer can help facilities and providers follow the labyrinth of rules and regulations, and can help them fight against allegations of fraud or wrongdoing.

2. Which Federal Agencies Regulate Laboratories?

Lab owners are generally aware of the regulatory authority that the U.S. Food and Drug Administration (FDA) has over their labs. Many are also aware...

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