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Legal Insights and Perspectives for the Healthcare Industry

In a recent LawFlash, our colleagues in the white collar practice discussed the US Department of Justice’s (DOJ’s) Criminal Division’s update to its Evaluation of Corporate Compliance Programs guidance, which is used by its prosecutors to assess the adequacy and effectiveness of corporate compliance programs in corporate criminal resolutions. The updated guidance retains nearly all of the language and questions contained in the previous guidance released in April 2019, but the new update provides clarifications and refinements in key areas, including with regard to access to compliance-related data. Healthcare companies may be interested to review the recent updates that provide insights and useful clarification that can aid legal and compliance departments.

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The Office of Management and Budget’s (OMB’s) policy statement emphasizes the role of the Congressional Review Act in the rulemaking process and incorporates rulemaking actions that were not consistently subject to prepublication review under standing executive orders. Questions remain regarding the prospects for regulatory gridlock and burdensome delays.

A recent OMB memorandum instructs departments and agencies of the executive branch to submit “guidance documents, general statements of policy, and interpretive rules” to the OMB’s Office of Information and Regulatory Affairs (OIRA) for prepublication review. The April 11 memorandum, which also expands OIRA review to agency rules historically submitted through the centralized process designated in Executive Order 12866, is effective May 11, 2019. Regulatory watchers caution that the OMB’s action could increase the volume of rules that require OIRA review and potentially result in regulatory gridlock and rulemaking delays.