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INDUSTRY PERSPECTIVESPharmaVOICE Webcasts - Truth, Misconceptions, Open Issues, and OIG Recommendations
 ARTICLESMeeting the Compliance Challenges of DRA With the passage of the Medicare Modernization Act, TRICARE, and most recently, the Deficit Reduction Act, it has become clear that the climate of regulatory activism gripping the pharmaceutical industry is unlikely to abate any time soon. While the compliance requirements of each of these mandates, and future ones, can certainly be met on a case by case basis, this approach will place companies on a never-ending treadmill. » Read more... INDUSTRY SURVEYThe survey was conducted to highlight key areas of confusion about the Deficit Reduction Act (DRA) and to determine if there is consensus among Pharmaceutical manufacturers as to how those areas should be addressed. The survey also highlights how much of a role manufacturers are playing in influencing these key areas. » Survey Summary |
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DRA will significantly change the calculation and reporting requirements of the Medicaid Drug Rebate Program. Specifically, DRA will change the AMP and BP calculation procedures, the content and timing of CMS submissions and potentially contracting and discounting strategies. Donna Lee Yesner, partner of McKenna Long & Aldridge LLP and I-many will explain the DRA impacts, OIG's recommendations and CMS' response, and the approach to addressing these changes.
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