With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the Department of Justice for years to come. Biopharma companies and manufacturers must carefully consider the facts and safeguards applicable to any sponsored
Second Circuit: Disclosures Made Only to the Government are not “Public Disclosures” Triggering the Public Disclosure Bar
The Second Circuit, in United States ex rel. Foreman v. AECOM, No. 20-2756-cv, 2021 WL 5406437 (2d Cir. Nov. 19, 2021), addressed a question it had not previously decided, namely, whether disclosures made solely to the government are “public disclosures” sufficient to trigger the public disclosure bar under the False Claims Act (FCA).
The public
New FCA Amendments Pass Judiciary Committee and Advance to Floor Vote
On October 28, the Senate Committee on the Judiciary approved for consideration by the full Senate the False Claims Amendments Act of 2021 (“FCA-2021”). The primary sponsor of the bill (S. 2428) is Sen. Chuck Grassley (R-IA), and there are four cosponsors: Sen. Richard Durban (D-IL), Sen. John Kennedy (R-LA), Sen. Patrick Leahy (D-VT) and