On Friday, May 24, 2013, ISTA Pharmaceuticals, Inc., a pharmaceutical company recently acquired by Bausch & Lomb, Inc., pled guilty to violating the Federal Anti-Kickback Statute and the Food, Drug and Cosmetic Act (FDCA). Under the terms of a civil settlement agreement and ISTA’s guilty plea, the pharmaceutical company has…
On September 4, 2011, the Office of Inspector General (“OIG”) issued an unfavorable advisory opinion (Advisory Opinion No. 12-11), which addressed an ambulance supplier’s proposed agreement with a municipality to waive cost-sharing amounts for emergency medical services (“EMS”). The requestor of the opinion, a for-profit provider of basic life support…
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published an advisory opinion regarding the Anti-Kickback Statute. The OIG concluded that the Anti-Kickback Statute would not be implicated where a charitable donation is made in the name of a healthcare provider, so long as…