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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Supreme Court to Review Plan Reimbursement Provisions

The Supreme Court recently agreed to rule on a case that could limit the ability of plans to recover money under their reimbursement provisions. Employee benefit plans often cover the medical bills of participants, but require full reimbursement to the plan when those participants recover from third parties. Under …

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SCOTUS to Review Health Care Reform

As expected, the Supreme Court has agreed to rule on the constitutionality of key provisions of the Affordable Care Act. Oral arguments are expected to occur in March 2012, with a decision likely in June 2012. The Court will consider the following issues: Anti-Injunction Act: Is the lawsuit challenging the …

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Health Care Reform – Litigation Update

In a decision issued yesterday, yet another appellate court weighed in on the constitutionality of the individual mandate. Here are some highlights: The case was Seven-Sky v. Holder, and it was a 2-1 decision of of the United States Court of Appeals for the District of Columbia Circuit. The panel that decided …

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Supreme Court Decision on Review of Health Care Reform Could Come Within Next Two Weeks

Here is an update on the possibility of Supreme Court review of health care reform since our last post on this matter. The Supreme Court could decide to review the constitutionality of the individual mandate as soon as November 10, 2011. On that date, in a private conference, the justices will determine which …

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