Additional Medicare Reporting Under the Sunshine Act Rules of 2013

Instructor: Mukesh Kumar
Product ID: 702998
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.

Why Should You Attend:

The Sunshine Act exposes the physicians and manufacturers to new reporting requirements which are unprecedented in their scope and detail. Non-compliance to these requirements would lead to hefty fines. 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.

This webinar will summarize the new medicare reporting requirements and provide practical solutions to most common situations that are prevalent and necessary between life-science product manufacturers and physicians. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements, and time-lines for compliance and enforcement will be discussed.

Areas Covered in the Webinar:

  • 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.

Who will Benefit:

This webinar will provide valuable information to:

  • 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

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and 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 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

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.

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