As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020. Importantly, the Centers for Medicare and Medicaid Services (CMS) does not consider Open Payments data to be completely reported until the final attestation is received by CMS.

As background, the Federal Open Payments program (the “Sunshine Act”) requires certain manufacturers of drugs, medical devices, biologicals, or other medical supplies covered under the Medicare, Medicaid, or CHIP programs (as well as group purchasing organizations (GPOs) who engage in transactions with such products) to annually report the following information to CMS:

1. Direct and indirect payments or other transfers of value made to physicians and teaching hospitals; and

2. Certain ownership or investment interests held by physicians or their immediate family members.

In October 2020, CMS and the U.S. Department of Justice (DOJ) announced their first settlement in relation to the Open Payments program pursuant to which medical device manufacturer, Medtronic USA Inc., was required to pay over $9.2 million to resolve allegations that it violated the Open Payments program. In brief, CMS and DOJ alleged that Medtronic underreported payments it had made to a restaurant owned by a physician that Medtronic used for numerous social events. The Medtronic settlement serves as an important reminder that the federal government is becomingly increasingly savvy in enforcing Open Payments requirements and that manufacturers and other stakeholders must comply with the Open Payments program.

Finally, it is important to note that the 2021 reporting period is the final period in which Open Payments program participants will submit reporting under the current Open Payments reporting regime. Beginning Jan. 1, 2021, the Open Payments program was expanded to include five additional provider types for which manufacturers and other affected entities must track and report Open Payments data. These new provider types include: physician assistants, nurse practitioners, certified nurse-midwives, clinical nurse specialists, and certified registered nurse anesthetists (CRNAs) and anesthesiology assistants. While the 2021 Open Payments reporting cycle will not include data related to these new provider types, Open Payments program participants should currently be tracking and documenting Open Payments data for these provider types in anticipation of the 2022 reporting cycle.

If you or your organization require assistance in reporting Open Payments data for the 2021 or 2022 program years, please contact your Dinsmore attorney to learn more about Open Payments reporting requirements and how we can assist you in tracking, documenting, and reporting such information in order to comply with Open Payments reporting obligations.