Sunshine Act Reporting for FDA-Regulated Manufacturers: New Rules

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Comprehend The Current Rules Under The Sunshine Act

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 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

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?

  • Physicians and other prescribers of medical products
  • Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies
  • Financial analysts and investors, venture capitalists, insurance professionals
  • Legal experts involved in assisting physicians and patients alike with medical malpractice
  • Medical accounting companies
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

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 ( 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...   More Info
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