Bloomberg Quotes Robert Salcido on DOJ’s “Brand Memo” and Impact on False Claims Act
Akin Gump health care and life sciences partner Robert Salcido has been quoted by Bloomberg for the article “Trump Administration Offers Relief From Agency Guidance,” on a new memorandum from the Department of Justice noting that agency guidance documents should not be relied upon to establish violation in affirmative civil enforcement cases.
Salcido, whose practice focuses on defense of False Claims Act lawsuits, said, “This is, I think, the first administration that has really brought in a particular regulatory viewpoint that differs from prior administrations. And I think the Brand memo is a manifestation of that.”
He said that those doing business with the federal government have an affirmative obligation to ensure the accuracy of the claims they make. Traditionally, this has involved reading statute, regulation and sub-regulatory guidance; however, companies have not always been aware of the sub-regulatory guidance. Notwithstanding, he said, the government’s position is that the company had “constructive knowledge” of that guidance or that it should have been aware of the guidance before submitting a claim.
Salcido said that the “Brand memo” (named for Associate Attorney General Rachel Brand, who issued the document) appears to absolve affected entities, primarily health care companies, of the responsibility of understanding agency and policy statements that have not passed through notice-and-comment rulemaking.
Of the fact that companies can arrive with their own reasonable interpretations of statutes or regulations, Salcido said, “If that’s the existing paradigm we live under, then that’s going to dramatically transform the way the False Claims Act is applied going forward.”
If, however, an agency wants to define obligations and duties, it must do so through binding rules, which require the notice-and-comment process, he added.