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HHS Clarifies NPDB Reporting Obligations

Client Alert | 1 min read | 09.24.03

Some health care entities have expressed concern that the National Practitioner Data Bank regulations require health care entities to report adverse actions taken against practitioners to both the NPDB and the applicable State Board of Medical Examiners, while the NPDB Guidebook directs health care entities to report directly to the NPDB first, and then subsequently to send to the State Board the Report Verification Document that the NPDB sends to the plan confirming receipt of the adverse action report in satisfaction of the plan's Board reporting obligation. We requested confirmation of health care entity obligations from the NPDB, and received the attached letter from HRSA Deputy Administrator Cynthia Grubbs in response. The letter confirms the process set forth in the Guidebook, and should provide additional comfort to health care entities who may have been unsure of their obligations.

Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA), We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....