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 the 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.
Join Dr. Mukesh Kumar in this 90 minute session to get a summary of the rules under the Sunshine Act, and tips for assuring compliance to protect both the manufacturers and physicians. He will discuss the practical strategies for complying with the current rules using case studies and examples of scenarios. At the end the attendees would be provided with useful web-links and suggestions for templates for reporting to CMS.
Topics covered in the session:
The Sunshine Act exposes the physicians and manufacturers to new reporting requirements which are unprecedented in their scope and detail noncompliance which would lead to hefty fines. Dr. Mukesh Kumar 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 also be discussed.
Who should attend?
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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