As the world has moved towards globalization, competition has increased in the marketplace. Healthcare related companies such as pharmaceuticals and healthcare device manufactures (collectively herein referred to as healthcare industry) are moving towards creative ways of advertising and communication as a strategic marketing tool to increase their market share. However, the healthcare industry is subject to complex laws and regulations, not being compliant can lead to severe penalties. Marketing practices that may be acceptable in other industries are not so in healthcare industry as the products from healthcare industries may pose significant health risks.
This paper discusses the Anti-Kickback statue as it applies to Clinical Research …show more content…
1320a-7b provides that one may not knowingly or willingly pay, solicit, or receive remuneration (direct or indirect) of any kind (bribe, kickback, rebate) to induce business reimbursed under a federal health care program (includes both Medicare and Medicaid programs). The essence of the violation is the inducement meaning, to lead or move by influence or persuasion. Of special note is that the law can be violated even if inducement is not the sole purpose for remuneration. It is enough that only one purpose, out of several, is to induce future Medicare/Medicaid reimbursable business. In this context, a kickback is equivalent to a bribe.
Brief of Biovail Pharmaceuticals case
Through a disguise of clinical research, Biovail Pharmaceuticals conducted a study titled “Proving LA through Clinical Experience” or PLACE, where physicians were asked to prescribe or recommend company’s product Cardizem and fill out some forms for which, the physicians who participated in the study received payments in excess of fair market value. In addition, Biovail’s salesforce was heavily involved in recruiting investigators, and PLACE was not designed in a manner that would provide new or meaningful scientific data about the drug.
How does the Biovail’s case relate to Anti-Kickback
This paper discusses the Anti-Kickback statue as it applies to Clinical Research …show more content…
1320a-7b provides that one may not knowingly or willingly pay, solicit, or receive remuneration (direct or indirect) of any kind (bribe, kickback, rebate) to induce business reimbursed under a federal health care program (includes both Medicare and Medicaid programs). The essence of the violation is the inducement meaning, to lead or move by influence or persuasion. Of special note is that the law can be violated even if inducement is not the sole purpose for remuneration. It is enough that only one purpose, out of several, is to induce future Medicare/Medicaid reimbursable business. In this context, a kickback is equivalent to a bribe.
Brief of Biovail Pharmaceuticals case
Through a disguise of clinical research, Biovail Pharmaceuticals conducted a study titled “Proving LA through Clinical Experience” or PLACE, where physicians were asked to prescribe or recommend company’s product Cardizem and fill out some forms for which, the physicians who participated in the study received payments in excess of fair market value. In addition, Biovail’s salesforce was heavily involved in recruiting investigators, and PLACE was not designed in a manner that would provide new or meaningful scientific data about the drug.
How does the Biovail’s case relate to Anti-Kickback