Category: Fraud and Abuse

FDA “Bad Ads” – Now for CME Credit…

On October 25, 2013, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) updated its “Bad Ad Program” website to add an accredited CME module and case studies, designed to “educate healthcare professionals and students about the role they can play in helping the FDA ensure that […]

Wyeth’s $491 Million Fraud Settlement

The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted […]

OIG Blesses Tiered Rebate Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently determined that a proposed tiered rebate program would not constitute grounds for sanctions under the federal health care program anti-kickback statute (42 U.S.C. § 1320a-7b(b)(7)), or the civil monetary penalty provision of the Social Security Act […]

Electronic Submissions Now Available for OIG Voluntary Disclosures

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released an on-line Provider Self-Disclosure Protocol (“Protocol”) submission form for individuals and entities that seek to disclose to the OIG potential violations of criminal, civil, or administrative law governing health care programs for which exclusion or […]