Comment/Response Document

Comment Response

In response to the 60-day comment period, CMS received one comment concerning reporting entity burden estimates presented in this information collection package. The comment came from an industry association representing a number of applicable manufacturers covered by Open Payments reporting requirements. The commenter indicated that their organization conducted an informal survey of approximately 30 reporting entities and that their results suggested that the actual burden experienced by reporting entities is substantially higher than CMS’s estimates. The commenter acknowledged the informal nature of their survey as well as the small sample size. The commenter recommended that CMS conducts a scientifically designed survey of a larger sample of reporting entities to get more accurate estimates of industry burden. CMS will explore the feasibility of conducting such survey within the constraints of available program budget. Given the admittedly unscientific nature of the survey conducted by the commenter, CMS believes that our burden estimates are accurate therefore at time no revisions will be made.