The Open Payments reporting period for payments made in calendar year 2015 by applicable pharmaceutical, device, biological, and medical supply manufacturers to physicians and teaching hospitals ended on March 31, 2016. CMS made only minor changes and enhancements to the reporting system, mostly to improve user experience. One more significant change was requiring reporting entities to provide at least one contact person for the review and dispute period, which runs from April to mid-May. The contact information will be made available to covered recipients to assist with the dispute resolution process and will be displayed on each individual payment record page.
Now that three cycles of Open Payments reporting have been completed, it is a good time for applicable manufacturers to review policies and procedures that were initially developed in anticipation of transparency reporting requirements and determine whether any changes are needed. In particular, while CMS still seems to be focusing on education rather than enforcement, applicable manufacturers should ensure that payments and transfers of value are being captured and recorded accurately. In addition, assumptions statements should be reviewed and updated accordingly, especially in light of the fact that the Open Payments system limits attestation statements to 4,000 characters (about one page). Finally, the following changes to reporting requirements for calendar year 2016 should be incorporated into policies:
- Indirect payments or other transfers of value to physician speakers at accredited or certified continuing medical education events now must be reported, provided that the applicable manufacturer knows or learns the identity of the physician speakers within the reporting year or by the end of the second quarter of the following reporting year. The exemption for reporting these payments or other transfers of value has been removed, effective beginning with the 2016 program year.
- Device and medical supplies manufacturers must now report, in conjunction with a payment or other transfer of value, the marketed name and therapeutic area or product category of the related device or medical supply, unless the payment or other transfer of value is not related to a particular item. This change brings the requirements for reporting for devices and medical supplies in line with the requirements already in place for drugs and biologicals.
- Stocks, stock options, and any other ownership interests must now be reported as distinct forms of payment. In prior years, stocks, stock options, and any other ownership interests were reported collectively in one category.
Physicians and teaching hospitals should be sure to review information reported about them for accuracy and file disputes as may be necessary. CMS is providing a free presentation on April 12, 2016 at 2:30 pm ET to educate physicians and teaching hospitals on how to access Open Payments and review data before it is published this summer.
For assistance with Open Payments matters – from developing policies to disputing data – contact Health Sciences Law Group.