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Defending Toxicology Laboratories in PGX Testing Fraud Cases

Toxicology Laboratories investigation

 

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 experiencing a bad reaction to a particular medication.  PGX testing is commonly used to determine a patient’s tolerance to narcotic pain medication as well as to address cancer treatments.

What Is PGX Testing Fraud?

PGX testing fraud occurs when a healthcare program is improperly billed for PGX testing.  For example, while Medicare does cover PGX testing for patients with a diagnosed disease or ailment, Medicare does not cover PGX testing when it is used merely for pre-symptomatic screening purposes.  Therefore, laboratories that bill Medicare for PGX screening tests may be violation of the False Claims Act.  Additionally, laboratories that pay kickbacks to physicians for PGX testing referrals may violate the federal Anti-Kickback Statute.  Laboratories may also run afoul of the Stark Law and False Claims Act if they have a financial relationship with any of the physicians who refer patient samples to them.

What Penalties Do Laboratories Face for PGX Testing Fraud?

PGX testing fraud is punishable under the same statutes as most other healthcare fraud – the False Claims Act (31 U.S.C. § 3729 et seq.), the healthcare fraud statute (18 U.S.C. § 1347), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), and the Stark Law (42 U.S.C. § 1395nn).  Each of the aforementioned statutes provide civil penalties for violation, including civil monetary penalties, denial of payment, and exclusion from federal programs.  Additionally, the False Claims Act, the Anti-Kickback Statute and the healthcare fraud statute provide criminal penalties, including criminal charges, indictments, prison sentences, probation, and criminal fines.  Civil or criminal charges may be brought against both the laboratory itself as well as the individuals owning or operating the laboratory.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Attorney-at-Law & Founder

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Lynette S. Byrd
Lynette S. Byrd

Former Federal Prosecutor

Partner

Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Subodh Chandra
Subodh Chandra

Former Federal Prosecutor

Local Counsel

Elizabeth K. Stepp
Elizabeth K. Stepp

Partner

Roger Bach
Roger Bach
(Non-Lawyer)

Former Special Agent, OIG

Dennis A. Wichern
Dennis A. Wichern
(Non-Lawyer)

Former Special Agent-in-Charge

Chris Quick
Chris Quick
(Non-Lawyer)

Former Special Agent, FBI

Kevin M. Sheridan
Kevin M. Sheridan
(Non-Lawyer)

Retired Supervisory Special Agent, FBI

Ray Yuen
Ray Yuen
(Non-Lawyer)

Former Supervisory Special Agent, FBI

Gamal Abdel-Hafiz
Gamal Abdel-Hafiz
(Non-Lawyer)

Former Supervisory Special Agent, FBI

Contact Experienced Attorneys

The former federal prosecutors and experienced defense attorneys at Oberheiden, P.C. represent toxicology laboratories, healthcare providers and business owners throughout the United States facing being investigated for violations of the Anti-Kickback Statute, the Stark Law, the False Claims Act, and other healthcare violations.  With an intimate understanding of the healthcare industry and extensive knowledge of healthcare laws, we know what to expect from federal investigators and how best to negotiate with them.  We have a proven track record of helping our clients successfully defeat charges of laboratory fraud.

  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (Stark Law Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
  • Toxicology Laboratory (False Claims Act Investigation)
    Result: Case concluded with no liability for our client.
Oberheiden, P.C.
Healthcare Compliance – Litigation – Defense
(214) 692-2171
www.federal-lawyer.com
This information has been prepared for informational purposes only and does not constitute legal advice. This information may constitute attorney advertising in some jurisdictions. Reading of this information does not create an attorney-client relationship. Prior results do not guarantee similar future outcomes. Oberheiden, P.C. is a Texas LLP with headquarters in Dallas. Mr. Oberheiden limits his practice to federal law.

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