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 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.
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.
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.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.