As a result of a qui tam action commenced pursuant to the whistleblower provisions of the False Claims Act, pharmaceutical company Sanofi US Agreed this week to Pay $109 Million to resolve False Claims Act Allegations of free product kickbacks to physicians. Pursuant to the allegations, Sanofi agreed to give free units of Hyalgan, a knee injection, to physicians who agreed to purchase and prescribe the product. By giving these free units, and by throwing the physicians lavish parties, all of which constitutes a kickback pursuant to the anti-kickback statutes, Sanofi enticed physicians to choose its product over another lower priced competitor.
As set forth in the Press Release issued by the Department of Justice, “Kickback schemes subvert the health care marketplace and undermine the integrity of public health care programs.” Further, patients expect their health providers to be concerned solely with their best medical interests. … Kickbacks undermine that all-important patient trust, and taxpayers’ expectation that government health dollars be put only to the wisest of uses.”
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative;, an initiative between the offices of the U.S. Attorney General and the Health and Human Services to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover $10.1 billion since January 2009.
N.B. Many drug and biologic companies provide physicians with free samples that the physicians may give to patients free of charge. It is legal to give these samples to your patients for free, but it is illegal to sell the samples. The Federal Government has prosecuted physicians for billing Medicare for free samples. If you choose to accept samples, you will need reliable systems in place to safely store the samples and ensure that samples are not commingled with your commercial stock.
