Webinars >>Sunshine Act
Additional Medicare Reporting Under the Sunshine Act Rules of 2013

Healthcare reforms enacted in 2010, generally referred to as Obamacare, included new provisions for disclosure of financial relationships between manufacturers of prescription products and physicians. These provisions, called as the “Sunshine Reporting Requirements”, include detailed and timely reporting of all payments made by manufacturers to physicians. The new rules, which will be enforced by the Center for Medicare and Medicaid Services (CMS) starting August 2013, would require new accounting practices and disclosures by both the manufactures and physicians, and the findings will be reported in a web-site maintained by the CMS to be available to public. The rules published by CMS provides great details of the kind of relationships, the mode of disclosure, the methods for verifying accuracy of reported information, publication schedule for CMS’s web-site and penalties for non-reporting or erroneous information for both manufacturers and physicians. This webinar will provide a summary of these rules, and tips for assurance compliance to protect both the manufacturers and physicians.
Areas Covered in the Session:
  • The provision and rationale for the Sunshine Act, 2010 and CMS’s Final Rule
  • Definitions of covered products and covered entities
  • Kind of payments covered and exempted for reporting to CMS
  • Format of reporting to CMS
  • Dealing with CMS’s inquiries regarding reported information
  • Acceptable and Unacceptable practices
  • Comparison of Federal reporting requirements with Industry best practices
  • Legal and practical implications of reporting financial information for manufacturers and physicians
  • Regulatory solutions for most common anticipated issues with reporting.
Why should you attend:
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The Sunshine Act exposes the physicians and manufacturers to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This seminar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between manufacturers and physicians. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements, and time-lines for compliance and enforcement will be discussed.
Who will benefit:
  • The provision and rationale for the Sunshine Act, 2010 and CMS’s Final Rule
  • Definitions of covered products and covered entities
  • Kind of payments covered and exempted for reporting to CMS
  • Format of reporting to CMS
  • Dealing with CMS’s inquiries regarding reported information
  • Acceptable and Unacceptable practices
  • Comparison of Federal reporting requirements with Industry best practices
  • Legal and practical implications of reporting financial information for manufacturers and physicians
  • Regulatory solutions for most common anticipated issues with reporting
Date: June 8, 2016
Time: 1 PM ET        
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC, VP (Regulatory Affairs and Quality Assurance), Amarex Clinical Research, USA
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com