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The Countdown Begins – Sunshine Act Data Collection

Written by Kate Stewart

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers of value.  As discussed in previous posts, the Act requires that applicable manufactures (“Manufacturers”) begin collecting data on payments and other transfers of value to physicians and teaching hospitals on August 1, 2013, and make initial reports to CMS by March 31, 2014.

Both the industry App and the physician App are free to download for iOS (Apple) and Android platforms.  Once downloaded, the physician App allows a physician to input information to track payments from vendors, including drop-down menus to select the form and nature of each payment. Similarly, the industry App allows the input of required physician information (including NPI and state license number) and then allows separate inputs for each payment made to a physician.  Both Apps also incorporate a QR code reader.  Manufacturers may wish to consider how they can incorporate QR codes into certain payments and transfers of value to help track payments.  Users can export the data from the Apps, but the Apps cannot be used to send annual reports directly to CMS.

Updated Sunshine Act FAQs

CMS has continued to issue additional implementation guidance in Frequently Asked Questions (“FAQs”) on the Open Payments website.  The new FAQs address a number of questions that have been raised by affected entities since the Act’s Final Rule was issued in February.

provide a list of potential speakers to conference organizers.  The FAQ clarifies that, so long as these three requirements are met, the cost of lodging, travel, and meals for speakers at accredited CME conferences is also exempt from reporting.  However, the cost of lodging,

CME Conferences

How payments and transfers of value related to accredited continuing medical education (CME) conferences are to be reported has been a vexing issue for Manufacturers. The FAQs provide clarification on reporting transfers of value to conference speakers and on reporting the value of slides and handouts made available to conference attendees. The Final Rule provides an exemption from reporting fees paid to speakers at accredited CME conferences, provided that three criteria are met: (i) the conference is accredited, (ii) the Manufacturer does not pay the speaker directly, and (iii) the Manufacturer does not select the speaker or travel, and meals for non-speaker attendees must be reported using the appropriate category.  Additionally, if an accredited CME conference (meeting the exemption criteria above) provides slides or handouts to attendees are part of their tuition fee, the value of those materials need not be reported, so long as (i) the content is related to the CME program and does not include any sponsor information, (ii) the value of the materials is de minimis, and (iii) the funds used to create the materials came from the same CME grant.

Journal Reprints

Manufacturers have also questioned how to assign a value to reprints of journal articles that they provide to physicians.  An FAQ clarifies that the value to be reported is the value the Manufacturer pays to acquire the reprints from the publisher.  Manufacturers can submit an assumptions document to CMS demonstrating how they determine this value.

Correcting Records

The process for correcting records after submission to CMS has also raised a number of questions.  An FAQ explains that if a Manufacturer or GPO needs to correct a submission, it will not have to retract and resubmit an entire report if an error needs to be corrected.  Instead, a group or records can be corrected and resubmitted or, if new data must be reported, it can be appended and submitted.

Other Sunshine Act Updates

A second National Provider Call from the Center for Program Integrity has been scheduled for August 8, 2013 from 2:30pm to 4:00pm.  Registration is not yet available, but information will be made available at CMS’s Open Payments website.



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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.