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Government Investigations of Research Studies

Government Investigations of Research Studies

Federal law enforcement agencies are increasingly scrutinizing medical research studies for violations of health care 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 Research Studies

Disguised Kickback Schemes:  In some cases, pharmaceutical companies have used research studies to disguise the provision of improper compensation to doctors for referring their products to patients.  In this scenario, a pharmaceutical company will set up a research study regarding a medicine and will pay doctors for each patient they monitor taking the medication.  While compensating doctors for the fair market value of their time spent participating in a research study is legal, payments in excess of fair market value are improper kickbacks because that could incentivize doctors to prescribe the medications being researched.

Example:  Merck & Co. paid $399 million to settle allegations that it improperly compensated doctors for referrals by labeling the payments as “medical research fees.” (Source)

Disguised Marketing Schemes:  In this scenario, medical marketers may pay physicians to conduct and publicize studies on off-label uses of their medications to increase sales of those products.  Marketers may also ghost write articles about their products for doctors to publish and then pay doctors large speaking fees to give speeches about those products.  While doctors are legally allowed to prescribe medications and devices for off-label uses, marketers are not allowed to promote off-label uses of their products; this scheme helps medical marketers skirt those regulations.

Example:  AstraZeneca was forced to pay $520 million to resolve claims that it violated the False Claims Act by paying doctors to conduct and promote research studies into off label uses of their medications.  (Source)

Patient Kickback Schemes:  Medical marketers have also used research studies as pretext for providing kickbacks to patients for filling prescriptions for their products.  Although medical researchers are legally allowed to compensate patients for participating in research studies, this scheme involves marketers taking advantage of that loophole by creating bogus research studies that are really meant to encourage patients to fill – and have their healthcare programs pay for – medically unnecessary medications.

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Dr. Nick Oberheiden

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Amanda Marshall

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Lynette S. Byrd

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Aaron L. Wiley

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Subodh Chandra

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Elizabeth K. Stepp

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Roger Bach
Roger Bach
(Non-Lawyer)

Former Special Agent, OIG

Dennis A. Wichern
Dennis A. Wichern
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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

Example: Several Dallas medical marketers were recently indicted for designing a fake medical research study into compound pain and scar creams and then paying Tricare beneficiaries $250 a month for each prescription they filled at the pharmacy the marketers represented.  (Source)
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Healthcare Compliance – Litigation – Defense
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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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