On March 25th, the Centers for Medicare & Medicaid Services (CMS) recognized that the COVID-19 pandemic may impact the ability for pharmaceutical and device manufactures plus distributors to report their Open Payments data by the March 31st deadline. CMS stopped short of extending the deadline and explained that it lacked the statutory authority to do so. However, CMS did state it “will exercise enforcement discretion with respect to submissions completed after the statutory deadline due to circumstances beyond the reporting entity’s control associated with the pandemic.”
CMS did not explain what it meant by “circumstances beyond the reporting entity’s control.” Instead, CMS asked for reporting entities to explain the circumstances within their assumptions statement. In the assumptions statement, reporting entities are asked to include the phrase “COVID-19 Impact,” an explanation of the circumstances, and any related help desk ticket numbers (if applicable).
Companies that have the ability to submit and attest to their data (all or partial) should do so by March 31st. While it is important for companies to submit reports timely, submitting accurate and complete information is essential. The exercise of enforcement discretion provides companies that did not report yet some flexibility in submitting their data after the deadline without penalty. It should be noted that there have been no known enforcement actions taken against companies since the inception of the Open Payments program.
Full Text of the Open Payments COVID-19 Announcement
CMS is aware that the COVID-19 pandemic may impact some reporting entities and may affect their ability to submit records to the Open Payments Program on or before March 31st 2020.
CMS does not have the authority to waive the statutorily mandated requirement that Open Payments reporting be completed by the 90th day of the calendar year (see 42 U.S.C. § 1320a–7h(a)(1)(A) and 42 U.S.C § 1320a–7h(a)(2)) or to postpone the publication deadline of June 30 (42 U.S.C § 1320a–7h(c)(1)(C)). As such, CMS is unable to extend the submission window past the March 31st deadline.
However, CMS is sensitive to the challenges caused by the pandemic and will consider the impact that these circumstances have on reporting entities’ ability to report in a timely, accurate, and complete manner.
CMS will exercise enforcement discretion with respect to submissions completed after the statutory deadline due to circumstances beyond the reporting entity’s control associated with the pandemic. In an assumptions statement, you may explain your organization’s reporting methodologies or reasons for unusual or partial submissions.
If the pandemic has impacted your reporting processes, please include the phrase “COVID-19 Impact” in your assumptions statement alongside the explanation of the circumstances and, if applicable, include reference to any related help desk ticket numbers.