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DOJ Memo Limits the Use of Agency Guidance in FCA Enforcement

Client Alert | 1 min read | 02.22.18

A recent memorandum issued by Associate Attorney General Rachel Brand (Brand Memo) prevents Department of Justice (DOJ) civil litigators from relying on agency guidance documents to demonstrate violations of the False Claims Act (FCA).  Specifically, the Brand Memo prohibits using noncompliance with agency guidance documents to presumptively or conclusively establish violation of the underlying law or regulation.  The Brand Memo references an earlier memorandum issued by Attorney General Jeff Sessions (Sessions Memo) that prohibits DOJ agencies from creating binding standards in guidance documents without engaging in notice-and-comment rulemaking.  The Brand Memo reiterates the core premise of the Sessions Memo – that guidance documents cannot create legal obligations.  It also expands on the Sessions Memo by directing DOJ litigators to apply that premise when interpreting other agencies’ guidance documents in civil enforcement actions.  While DOJ litigators may continue using agency guidance for “proper purposes,” such as to establish that a party had the requisite knowledge of a legal mandate because the party was familiar with a guidance document that explained it, this new policy represents a distinct limitation on the use of agency guidance in FCA enforcement.    

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Client Alert | 6 min read | 03.26.24

California Office of Health Care Affordability Notice Requirement for Material Change Transactions Closing on or After April 1, 2024

Starting next week, on April 1st, health care entities in California closing “material change transactions” will be required to notify California’s new Office of Health Care Affordability (“OHCA”) and potentially undergo an extensive review process prior to closing. The new review process will impact a broad range of providers, payers, delivery systems, and pharmacy benefit managers with either a current California footprint or a plan to expand into the California market. While health care service plans in California are already subject to an extensive transaction approval process by the Department of Managed Health Care, other health care entities in California have not been required to file notices of transactions historically, and so the notice requirement will have a significant impact on how health care entities need to structure and close deals in California, and the timing on which closing is permitted to occur....