CMS Announces Enforcement Discretion for Physician Payments Sunshine Act Reporting by Applicable Drug and Device Manufacturers

CMS announced today (with the details found here in its answers to Frequently Asked Questions) that in acknowledgment of the extreme circumstances posed by COVID-19, it will exercise enforcement discretion with respect to any Physician Payments Sunshine Act Open Payments reporting that is submitted after the March 31, 2020 deadline. CMS explained that while it does not have authority to delay the submission deadline (since that deadline is set by federal statute), CMS is sensitive to the challenges caused by the COVID-19 pandemic, and will exercise enforcement discretion by considering the impact of these circumstances on an entity’s ability to submit the information on time. Entities that submit data after the deadline should include the phrase “COVID-19 Impact” in an assumption statement along with the explanation about their COVID-19-related circumstances.

If you have any questions about this year’s Open Payments reporting or how to submit data, please contact the author or your regular Dorsey attorney or Dorsey Health Strategies consultant.

Shira Hauschen

Shira is Managing Principal of Dorsey Health Strategies. Shira has advised clients across a wide array of industry segments on topics including compliance with federal and state laws, healthcare IT, Big Data, telemedicine and mobile health, lean transformations (process improvement), vendor management, and integrated delivery systems. As a licensed attorney and via the integrated approach taken by Dorsey’s Health Care Industry Group, Shira’s consulting advice is attuned to and aligned with clients’ legal landscape.

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