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Dr. Nick Oberheiden
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Aaron Wiley
Former State &
Federal Prosecutor

S. Amanda Marshall
Former U.S. Attorney

Lynette Byrd
Former Assistant
U.S. Attorney

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Defending Toxicology Laboratories in PGX Testing Fraud Cases

Categories: DNA Testing

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.

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
(800) 810-0259
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.

Who Will Handle Your Case

When you hire us, you will not work with paralegals or junior lawyers. Each lawyer in our Health Care Practice Group has handled at least one hundred (100) matters in the health care industry. So, when you call, you can expect a lawyer that immediately connects with your concerns and who brings in a wealth of experience and competence. For example, you need someone like Lynette S. Byrd, a former federal prosecutor in health care matters, who recently left the government and who is now sharing the valuable insights she gained as a health care prosecutor with our clients.

Dr. Nick Oberheiden

Dr. Nick
OBERHEIDEN

Lynette S. Byrd

Lynette S.
BYRD

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