On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
9/25/2024
/ Appeals ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Documentation ,
False Claims Act (FCA) ,
Final Rules ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
New Regulations ,
Plagiarism ,
Public Health Service (PHS) ,
Statute of Limitations ,
Transcripts ,
Willful Misconduct
The Health Resources and Services Administration (HRSA) Uninsured Program (UIP), which reimbursed providers for provision of COVID-19 related services to uninsured individuals, paid out more than $24.5 billion in claims....more
8/18/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
Fraud ,
HRSA ,
Medicaid ,
Medicare ,
Noncompliance ,
OIG
In times of crisis, there are heroes, villains, victims, and everyone in between. Amidst the COVID-19 crisis, many valiant efforts are under immense time pressure—to care for the ill, to protect the vulnerable, to find and...more
Federal enforcers typically announce (formally as well as informally) work plans or focus areas for the upcoming year that can provide some guidance as to where providers might anticipate enforcement action and, where they...more
In a memo leaked last year (the Granston Memo), the U.S. Department of Justice (DOJ) instructed its prosecutors to more seriously consider dismissing meritless whistleblower False Claims Act (FCA) cases when it is in the...more
On May 7, 2019, the Department of Justice (DOJ) released guidance for civil prosecutors in determining how to assess cooperation in False Claims Act (FCA) cases. See DOJ’s press release and its revised manual. In particular,...more
Most busy scientific research laboratories have a spectrum of projects underway at any given time. Some projects are producing exciting results, and others seem to be heading nowhere. Why not shift personnel from the losers...more
On May 9, 2018, the U.S. Department of Justice (DOJ) announced a policy related to resolutions of criminal and civil corporate enforcement. The new “Policy on Coordination of Corporate Resolution Penalties” was issued by...more
For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services. After a lengthy and confidential review, an institution...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
In a January 10, 2018 memo that leaked last week (the “Granston Memo”), the U.S. Department of Justice (“DOJ”) directs its prosecutors to more seriously consider dismissing meritless False Claims Act (“FCA”) cases brought by...more