Reflections on an Era of Increasing Pharmaceutical Regulation: Medicaid Rebates and the Sunshine Act

The long-awaited “Sunshine Act” regulations are the latest in the federal government’s increasing list of regulatory requirements imposed on pharmaceutical manufacturers over the last 20-plus years.  Many questions remain about the scope of the proposed regulations requiring reporting and disclosure of manufacturer payments to physicians and teaching hospitals, as well their practical application.  Nevertheless, manufacturers must take steps now to prepare for their eventuality, including beefing up compliance departments that some in management probably view as already glutted.
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The Sun Rises on a New Era in Health Care Provider Relationships with Pharma and Device Companies

Supreme Court Justice Louis Branders famously said, “Sunshine is the best disinfectant.” In that spirit, Section 6002 of the Patient Protection and Affordable Care Act of 2010 (PPACA) imposes extensive disclosure obligations on pharmaceutical, device, biological and other medical supply companies (referred to as “applicable manufacturers”), if their products are paid for by Medicare or Medicaid.
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