The Department of Justice revised its manual Sept. 18 to support its fight against fraud under the False Claims Act through more clearly outlined standards to promote fairness and effective enforcement.
The first change in the manual reinstates and expands on the department’s 2017 policy that subregulatory guidance can’t impose legal obligations beyond those established by regulation or statute, according to a Justice Department news release.
“The Department of Justice should enforce the law, not make law through enforcement,” Associate Attorney General Stanley Woodward Jr. said in the release. “These updates reflect the Department’s commitment to fair notice, transparent enforcement and the rule of law.”
For healthcare organizations, agency guidance still carries weight. Prosecutors can use it as evidence of a party’s knowledge or of professional standards. The manual cites CMS’ Medicare Benefit Policy Manual specifically and local coverage determinations as relevant to if services were necessary and reasonable. When a provider agreement or government contract needs compliance with guidance, violating it can expose providers to liability.
The second manual revision flags that the Justice Department should consider exercising its dismissal authority when declining to intervene in a qui tam case. Where it does not look for dismissal, the department should revisit the assessment as needed during litigation.
“The Department will continue to exercise this authority judiciously, with an emphasis on seeking dismissal of qui tam actions that lack legal or factual merit and focusing Department resources on matters that advance the interests of the United States,” the release said.
The full Justice Manual revisions can be found here and here.
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