Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating
New tax law may have significant consequences for defendants settling False Claims Act suits
The Tax Cuts and Jobs Act may significantly limit the deductibility of False Claims Act settlements for defendants going forward.
Relator’s pharmacy allegations dismissed; government’s U&C allegations survive
Although a Florida compounding pharmacy has scored a win against a whistleblower’s allegations, it continues to defend against the government’s allegations of improper inflation of its Usual & Customary charges submitted to TRICARE.
The U.S. District Court for the Middle
South Dakota and Colorado strengthen data breach protections
Last week, South Dakota moved closer to implementing a data breach notification law, while Colorado legislators introduced a new bill requiring “reasonable security procedures,” imposing data disposal rules and shortening the time frame in which to alert authorities regarding a
FDA releases 2017 enforcement statistics and recall draft guidance
On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics.
Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters
Court applies Escobar, overturns $350M False Claims Act verdict
In Universal Health Services v. U.S. ex rel Escobar, the United States Supreme Court emphasized the importance of the materiality standard in False Claims Act cases. Since that decision, litigants have anxiously awaited further guidance on how Escobar’s instructions would
Centers for Medicare & Medicaid Services commits to supporting Medicaid work and community engagement requirements
On January 11, 2018, the Centers for Medicare & Medicaid Services (CMS) released a letter to State Medicaid Directors announcing a commitment to support section 1115 demonstration projects that include work or community engagement requirements. This will be the first
FDA relaxes FSMA enforcement
On January 5, 2018, the U.S. Food and Drug Administration (“FDA”) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The
The US Department of Labor proposes expanded access to association health plans
Pursuant to President Donald J. Trump’s October 12, 2017 Executive Order instructing the U.S. Department of Labor (DOL) to consider expanding access to association health plans (AHP), the DOL published a proposed rule on January 5, 2018 that would modify