March 30, 2020 –
The global pandemic caused by the Coronavirus has made policymakers within the Centers for Medicare & Medicaid Services (CMS) reevaluate their Open Payments submission deadline. Drug manufacturers had until Tuesday March 31, 2020 to submit their payment data for the year of 2019. But, given the enormous strain that the novel virus has put on the healthcare system and life science manufacturers, the ability to report payments within this window has been compromised.
In response to this challenge, CMS announced on March 26 that their reporting deadline, “cannot be extended past March 31, 2020, therefore, CMS will exercise enforcement discretion for submissions completed after the statutory deadline due to circumstances beyond the reporting entity’s control related to the pandemic.”
CMS’ response signals that each instance of a late submission would be reviewed in a case-by-case manner. And while some leniency will be given, the wording of CMS’ announcement definitely encourages organizations to submit their payment data within the predetermined window.
What manufacturers will be most affected? In all likelihood, most companies had their payments reports ready before the larger effects of the pandemic were felt. However, some organizations that manufacture respiratory, cardiovascular and other medications and devices associated with the lungs may have a challenging time organizing their payments data. Additionally, manufacturers that employ the services of epidemiologists or vaccine specialists may experience similar complications.
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ABOUT THE AUTHOR
Todd Middleton is a senior research analyst at Cutting Edge Information. In this position, he provides qualitative FMV information for in-house and external use to ensure compliant HCP engagements. As an analyst, Mr. Middleton affirms that accurate data, in combination with topical research, can ensure successful life science company compliance. He is a graduate of the College of Charleston.