Life science companies are struggling to under-stand the complex reporting requirements and compliance issues presented by existing and new regulations such as the Physician Payments Sunshine Act (PPSA), provisions of which were included in the Patient Protection and Affordable Care Act. While the looming challenge of complying with the Sunshine Act has consumed the attention of the drug and medical device industry, it has tended to obscure other issues of long-term strategic importance, such as the effect of transparency on public perception, and the need for industry to re-structure its spending practices with transparency in mind.
This article reviews the strategic implications of the Sunshine Act and also presents highlights of the draft regulations rule released by the Centers for Medicare and Medicaid Services on December 15, 2011.
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- Will We See Data for 2012?
- Foreign Drug Companies Also Covered
- "Common Ownership" Loophole Closed
- Identifying "Covered Physicians"
- The Multiple Drug Conundrum
- Assumptions About Categories of Information
- CME Lumped Into Speakers' Fees
- Under the Radar Food and Beverage Payments
- What's It Going to Cost?
- Competitive Intelligence Implications
- Ramifications for the Drug Industry
- Ramifications for the Medical Community