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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CMS Publishes FAQs Limiting SRDP Financial Analysis to Four-Year Reopening Period

CMS has released four new FAQs regarding the applicable reopening period and “look back” period for potential Stark violations disclosed through the voluntary Self-Referral Disclosure Protocol (SRDP).  The new FAQs clarify that a disclosing party may limit both (i) its disclosure of the total amount of …

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Day Three – The Supreme Court Hears Argument on the Severability of the Individual Mandate and State Sovereignty

On Wednesday, the U.S. Supreme Court heard oral argument on the two remaining issues involving the ACA. The morning session concerned the issue of severability–if the Court determines that the individual mandate is unconstitutional, can the mandate be severed from the rest of the ACA, or does it drag down part …

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Day Two – The Supreme Court Hears Argument on the Constitutionality of the ACA’s Individual Mandate

Yesterday, the Supreme Court heard two hours of oral argument on the constitutional issue that lies at the heart of the Affordable Care Act (“ACA”) cases: Does the federal government have the power to require citizens to maintain health insurance? Donald B. Verrilli, Jr., the Solicitor General of the United …

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The first day of Supreme Court arguments on the Affordable Care Act focuses on the Anti-Injunction Act

On Monday, the Supreme Court heard the first of three days of oral argument regarding the Affordable Care Act (“ACA”). This first day addressed a threshold question: Can the Court reach the constitutional challenges, or are the challenges premature under the Anti-Injunction Act of 1867? The Anti-Injunction …

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Schedule of Supreme Court Arguments

We know that many of our clients are eagerly awaiting the Supreme Court arguments regarding health care reform next week. Here’s the schedule for the arguments: Monday: 90 minutes, beginning at 10 a.m. Eastern time. The Court will hear arguments on whether the Anti Injunction Act prevents a challenge to the …

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