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The Centers for Medicare & Medicaid Services (CMS) recently posted data field templates to assist manufacturers with reporting of required information under the Physician Payments Sunshine Act (Sunshine Act).  CMS requires applicable manufacturers to commence data collection on August 1, 2013.  To assist applicable manufacturers, CMS has published three templates covering the format and specific information field requirements for reporting payments and transfers of value:

1. General Payments Template – This template covers payments made that are not in connection with research.  The template identifies 6 pages of information fields required for completion, including the payment recipient’s identifying and demographic information, the associated medical product, nature of payment made, and other miscellaneous data (e.g., whether it was a charitable payment or if it was made through a third party).
2. Physician Ownership Template – This template addresses reporting obligations for physician ownership of an applicable manufacturer.  The template requires information on the physician owner’s identifying and demographic information as well as a description of the nature of his or her investment interest in an applicable manufacturer.
3. Research Payment Template – This template is the most extensive with 14 pages of information fields as it includes research related data as well as identifying and demographic information on the principal investigator(s).  In addition, data is required on the associated medical product, context of the research, and whether the applicable manufacturer is requesting a delay in the publication of the research payment (i.e., for payments related to research of new products or new uses of marketed products).       

Manufacturer information technology teams should begin reviewing these templates in order to prepare and implement company tracking mechanisms that capture these data throughout the year.  In addition, note that CMS has posted some Frequently Asked Questions to provide guidance on the requirements of the Sunshine Act and its implementing regulations.  Some notable points include clarification of when the “date of payment” occurs.  According to CMS, the date of payment is the date on which a check was postmarked or the date on which funds transferred although there is some flexibility for certain payments (e.g., travel costs – date of ticket purchase vs. date of travel).  There is also additional clarification for manufacturers with less than 10% gross revenue from covered medical products, which have reduced reporting obligations.  CMS clarifies that gross revenue here includes global sales and not merely domestic sales.  Finally, CMS notes that it considers blood centers to be, in many situations, applicable manufacturers under the Sunshine Act.

Julie Tibbets is a partner in the Food, Drug & Device/FDA Practice of Alston & Bird LLP where she focuses her practice on advising manufacturers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related matters and interactions. This publication is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.  Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.