On March 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Open Payments Program COVID-19 announcement and released an updated comprehensive list of frequently asked questions about the Open Payments Program. CMS stated that the program’s March 31, 2020, deadline for reporting program year 2019 Open Payments data would remain the same, as the agency lacks authority to waive or postpone statutorily mandated deadlines. However, CMS announced that 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 stated that it is sensitive to the challenges caused by the COVID-19 pandemic and will consider the impact that these circumstances have on entities’ ability to report in a timely, accurate and complete manner, in deciding whether to impose civil monetary penalties.
For manufacturers and group purchasing organizations (GPOs) whose reporting process was affected by COVID-19, resulting in untimely, incomplete or inaccurate submissions, CMS instructed those reporting entities to include the phrase “COVID-19 Impact” in the assumptions document entry and “explain [the] organization’s reporting methodologies or reasons for unusual or partial submissions.” Manufacturers and GPOs should also include a reference to any related Open Payments help desk ticket numbers in the assumptions document.
Covered recipients — including U.S. licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse midwives and teaching hospitals — should expect this year’s review and dispute period to begin in April 2020 as scheduled. During that 45-day period, covered recipients will have an opportunity to review and dispute any records before they are initially published. Disputes or changes resulting from data submitted by manufacturers and GPOs after the deadline will be reflected in subsequent data publications.
CMS has the discretion to audit applicable manufacturers and GPOs at any time to ensure the submission of timely, accurate and complete reports on transfers of value to, or ownership or investment interests held by, covered recipients and their immediate family members. CMS may impose civil monetary penalties ranging from $1,176 to $11,766, for each payment or other transfer of value or each ownership or investment interest, as applicable, that is not appropriately reported, up to an annual limit of $176,495 (as adjusted for FY 2020). Knowingly failing to report Open Payments data may subject manufacturers and GPOs to civil monetary penalties ranging from $11,766 to $117,664 per violation, up to an annual limit of $1,176,638 (as adjusted for FY 2020). Applicable manufacturers and GPOs should ensure that they use reasonable efforts to report complete and accurate data on time and note any circumstances resulting in a delay on the assumptions document, identifying “COVID-19 Impact” as the overarching issue.
As the COVID-19 situation continues to evolve, CMS encourages all healthcare providers to monitor the Centers for Disease Control and Prevention website for up-to-date information and resources and to contact local health departments when needed. Please contact the authors for additional guidance on how other COVID-19 considerations may impact healthcare providers. McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues.