The agreement was signed on 2 September 2015, but was not published on the website of the Inspector General of the Office of Health and Human Resources until the end of November. “According to the allegations made in today`s transaction agreement, Sanofi used an alleged charity as a channel to give money to patients taking Sanofi`s expensive drug, all at the expense of the Medicare program,” said Andrew E. Lelling, the U.S. Attorney General. “This office will continue to sue drug companies for violations of anti-kickback laws. We commend Sanofi for quickly resolving the government`s accusations. This CIA is a precondition for other agreements reached by Sanofi and the United States to resolve accusations that Sanofi U.S. violated the False Claims Act between 2005 and 2009 by sending doctors to units free of its Hyalgan knee injection ® in violation of the anti-kickback status that led doctors to purchase and prescribe the product. The comparison also resolves accusations that Sanofi US filed false average selling price reports for Hyalgan® that did not take into account free units after Demhyalgan® purchase. The government claimed that these false average sales price reports led government programs to pay excessive amounts for Hyalgan® and a competing product.
CAMBRIDGE, Mass., February 28, 2020 /PRNewswire/ — Sanofi U.S. today announced that it has reached a $11.85 million settlement agreement with the federal government to clarify an investigation into certain financial donations made in 2015 and 2016 to an independent charitable association support foundation that supports patients with multiple sclerosis. On September 10, 2007, the U.S. Department of Justice announced that French pharmaceutical company Sanofi-Aventis (“Aventis”), formerly Aventis Pharmaceuticals Inc., had agreed to pay $190 million to respond to accusations that the company had caused false allegations about Medicare and other federal health programs. The transaction agreement was the result of the alleged fraudulent pricing and marketing of ANZEMET (Dolasetron-Mesylat), an antiemetic drug used primarily in relation to oncology and radiological treatment. The government investigation began after Ven-A-Care of Florida Keys Inc., a home merger, filed a complaint with the Federal False Claims Act (“FCA”). The ACF allows individuals to file legal action on behalf of the government. As part of the comparison, Ven-A-Care whistleblowers receive approximately $32 million. In exchange for the Department of Health and Human Services Office of Inspector General `OIG` agreement not to exclude Aventis from federal health programs, Aventis agreed to enter into a five-year enterprise integrity agreement (“CIA”). The CIA Aventis contains requirements: Save my name, email and website in this browser for the next time I comment.
When a Medicare recipient receives a medically prescribed drug under Medicare`s Part B, the recipient may be required to make a partial payment that may take the form of a co-payment, co-insurance or deductible (cumulative “co-payment”). These co-payment obligations can be important for expensive drugs. Congress has included some co-payment requirements in the Medicare program to encourage market forces to serve as health cost control, including the prices that pharmaceutical companies can charge for their drugs. The anti-kickback status prohibits pharmaceutical companies from offering or paying, directly or indirectly, compensation – which includes money or other valuable materials – to induce Medicare patients to purchase drugs from companies. Merit Medical to pay $18 million through the incorrect claims law and… . On February 28, 2020, the U.S. Department of Justice (DOJ) announced that Sanofi-Aventis U.S., LLC (Sanofi) has agreed to pay $11.85 million to refute allegations that it violated the False Claims Act (FCA) by paying bribes to Medicare patients through a non-profit foundation, the