Amanda S. Marshall
Former U.S. Attorney
(Local Counsel)
Lynette Byrd
Former Assistant
U.S. Attorney
Roger Bach
Former Special
Agent
(OIG & DEA)
Joe Brown
Former U.S. Attorney
Dr. Nick Oberheiden
Attorney & Founder
Mistakes to Avoid When Setting Up PGX Laboratories
New PGX laboratories often run into regulatory and compliance problems in the early stages of their development. While each lab is different, and their individual issues are unique, this entry addresses some of the most common problem areas for a new laboratory: Establishing an Effective Compliance Department. An engaged and...
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Defending Toxicology Laboratories in PGX Testing Fraud Cases
What Is PGX Testing? PGX testing is an emerging medical technology within the field of clinical laboratories that uses a patient’s DNA to predict how that patient will react to medication. Doctors can use PGX testing to tailor treatment regimens for individual patients as well as to prevent a patient...
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Government Investigations of Research Studies
Federal law enforcement agencies are increasingly scrutinizing medical research studies for violations of healthcare regulations. In particular, investigators are determined to hold physicians, pharmaceutical companies and medical researchers accountable for misuses of medical research studies as a means to violate the Anti-Kickback Statute and commit healthcare fraud. Fraud Allegations in...
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How to Defend PGX Laboratories Against Healthcare Fraud Charges
The Government’s Allegations Over the past few years, the United States government has placed a particular focus on detecting and prosecuting healthcare fraud among laboratories, even issuing several Special Fraud Alerts regarding common types of fraud committed by laboratories. Federal investigators are currently scrutinizing financial relationships between laboratories and referring...
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