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Keeping you afloat amidst the rising sea of regulations

What the Department of Justice Expects in a Compliance Program

In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness.

Mylan Agrees to $465 Million Settlement with DOJ Over EpiPen Medicaid Drug Rebate Reporting Classification

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.),  an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).