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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.

CMS stated that while it is sensitive to the challenges caused by the coronavirus (COVID-19) pandemic, it does not have the authority to waive the statutory requirement that data be submitted by the March 31, 2020, deadline or to postpone the June 30, 2020, publication deadline. CMS will, however, “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,” and will consider the impact that these circumstances have on reporting entities’ ability to report in a timely, accurate, and complete manner in deciding whether to impose civil monetary penalties.

Any circumstances that result in untimely, inaccurate, or incomplete submissions, even in part, should be documented carefully in an assumptions document by applicable manufacturers and group purchasing organizations. CMS asks that in doing so, reporting entities include the phrase “COVID-19 Impact” in the assumptions document entry.

CMS also instructs applicable manufacturers and group purchasing organizations to include in the assumptions document a reference to any related Open Payments Help Desk ticket numbers, which indicates that despite this announcement, CMS still expects applicable manufacturers to do everything reasonably possible under the circumstances to report complete and accurate data on time.

Covered recipients should expect that this year’s Review and Dispute period will proceed as scheduled, and that it’s likely that covered recipients will have to review corrected Program Year 2019 data submitted after the deadline by some applicable manufacturers that will be published by CMS in later data updates.

Failure to submit timely, accurate, and complete data may subject applicable manufacturers and group purchasing organizations to a monetary civil penalty of $1,000 to $10,000 for each payment or other transfer of value or each ownership or investment interest, as applicable, that is not timely, accurately, or completely reported, up to $150,000 per annual submission (adjusted for percent increases in CPI).

Knowing failures to report are subject to civil monetary penalties of $10,000 to $100,000 per violation up to an annual maximum of $1 million (also adjusted for percent increases in CPI).

Coronavirus COVID-19 Task Force

For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold. If you would like to receive a daily digest of all new updates to the page, please subscribe now to receive our COVID-19 alerts.