OIG Special Fraud Alert Warns Physician Owned Distributors of Enforcement Actions

The Department of Health and Human Services’ Office of Inspector General (OIG) recently released long-awaited guidance on Physician Owned Distributors.  In a Special Fraud Alert released on March 26, 2013, OIG reiterated its long-standing position that physician-owned distributors (PODs) are inherently …

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CMS Releases Sunshine Law Final Rule

As is customary in Washington, a major announcement was made late on a Friday afternoon.  CMS issued the long-awaited, 15-months-overdue (see here) Final Rule implementing section 6002 of the Affordable Care Act, which added section 1128G to the Social Security Act, better known as the Sunshine Law.   CMS is …

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Is Off-Label Enforcement Off Limits?

On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …

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The RAC Wars – The Latest Shot

The latest shot in the war between hospitals and RACs has been fired.  The American Hospital Association (AHA) and four hospital systems brought a lawsuit against the Department of Health and Human Services (HHS), alleging that the government’s recovery audit contractor (RAC) program improperly demands …

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With Boehringer Ingelheim FCA Settlement, Government Continues To Expand Off-Label Enforcement and Enhance CIAs

Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) is the latest pharmaceutical manufacturer to enter into a False Claims Act settlement with the Department of Justice (“DOJ”) predicated on off-label marketing and promotion.  Last Friday, October 26, 2012, BIPI agreed to pay $95 million to resolve …

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More Problems With ZPICs

A recent OEI report found troubling conflicts of interest and financial relationships among potential Zone Program Integrity Contractors (ZPICs) used by the Centers for Medicare & Medicaid Services (CMS) in their controversial new National Fraud Prevention Program.  Medicare fraud costs the government an …

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