Del­ery: Fight­ing fraud re­quires more than mon­e­tary set­tle­ments

Modern Healthcare - - LATE NEWS -

In his first ma­jor public speech as head of the U.S. Jus­tice Depart­ment’s civil di­vi­sion, Stu­art Del­ery told an au­di­ence of cor­po­rate at­tor­neys in San Fran­cisco that fight­ing health­care fraud must in­clude sub­stan­tive penal­ties and reme­dies be­yond at­ten­tion­grab­bing mon­e­tary set­tle­ments. Del­ery’s com­ments came a week af­ter the di­vi­sion an­nounced one of its largest-ever set­tle­ments in health­care: a $1.5 bil­lion deal to re­solve crim­i­nal and civil al­le­ga­tions of off-la­bel mar­ket­ing of Depakote by Ab­bott Lab­o­ra­to­ries. That deal in­cluded sev­eral non­mon­e­tary reme­dies that re­quire com­pli­ance ac­tion by Ab­bott’s CEO and board of di­rec­tors. Del­ery was ap­pointed act­ing as­sis­tant at­tor­ney gen­eral for the Jus­tice Depart­ment’s civil di­vi­sion in March, re­plac­ing Tony West, who was pro­moted to act­ing as­so­ci­ate at­tor­ney gen­eral. Del­ery told a gath­er­ing of in-house lawyers who are mem­bers of the Amer­i­can Bar As­so­ci­a­tion how the Ab­bott set­tle­ment man­dates that the com­pany CEO per­son­ally cer­tify com­pli­ance with a re­quire­ment that the com­pany re­port “any prob­a­ble vi­o­la­tions” of the Food, Drug and Cos­metic Act to the in­ter­na­tional drug­maker’s pro­ba­tion of­fi­cer as a con­di­tion of its five-year pro­ba­tion, in ad­di­tion to a five-year cor­po­rate in­tegrity agree­ment that re­quires the com­pany’s board of di­rec­tors to re­view the ef­fec­tive­ness of its com­pli­ance pro­gram. “While we will con­tinue to seek sig­nif­i­cant mon­e­tary penal­ties where ap­pro­pri­ate, we will also seek to im­ple­ment ap­pro­pri­ate non­mon­e­tary mea­sures aimed at en­cour­ag­ing a cul­ture of com­pli­ance from within,” Del­ery said.

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