Case Study

CFS Clinical Helps Top 20 Pharma Improve Investigator Payment And Budget Management While Addressing Sunshine & FMV Compliance

Source: DrugDev
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Presented By Jim DiCesare, VP and General Manager, Contract and Regulatory Services

Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009.

Signed into law on March 23, 2010 with final guidance issued February 1, 2013, the “Sunshine Act” within PPACA requires drug and medical device manufacturers to publicly report gifts and payments made to “covered recipients.” Such recipients include physicians and teaching hospitals.

While many clinical trial sponsors are still grappling with how to accurately and efficiently prepare PPSP reports, which are due to be submitted electronically to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014, this company is well prepared. Partnering with CFS Clinical, the company had already taken proactive steps to address its goals around investigator payment management.
 

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