Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction...more
In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more
On January 21, 2025, President Trump issued an executive order titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” (the “EO”), which aims to eliminate diversity, equity, and inclusion (DEI) policies...more
What may have seemed like an out-of-the-blue question to the casual observer was no surprise to those who represent individuals and entities in the health care and life sciences industries: U.S. Attorney General (AG) nominee...more
On January 6, 2025, the U.S. District Court for the District of Massachusetts granted a defendant laboratory’s motion for summary judgment in a False Claims Act (FCA)/Anti-Kickback Statute (AKS) case brought by a physician...more
On January 15, 2025, the U.S. Department of Justice (DOJ) issued a press release announcing its fiscal year (FY) 2024 False Claims Act (FCA) recoveries and reported that settlements and judgments exceeded $2.9 billion in...more
1/17/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Life Sciences ,
Medicare Fraud ,
Qui Tam ,
Settlement ,
Trump Administration ,
Whistleblowers
In August, the United States filed a Complaint-in-Intervention in a False Claims Act (FCA) whistleblower suit alleging that the Georgia Institute of Technology (“Georgia Tech”) and an affiliate, Georgia Tech Research Corp....more
Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more
8/13/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Reform
On February 22, 2024, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2023, which ended on September 30, 2023. While the $2.68 billion in total...more
2/28/2024
/ Civil Investigation Demand ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Investigations ,
Healthcare ,
Healthcare Fraud ,
Medicare Advantage ,
Opioid ,
Private Equity ,
Qui Tam ,
Whistleblowers
On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022. While total recoveries exceeded $2.2...more
On February 1, 2022, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2021....more
On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud....more
In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma...more
On March 26, 2021, the U.S. Department of Justice (“DOJ”) reported on the agency’s heightened criminal and civil enforcement activities in connection with COVID-19-related fraud.[1] As of that date, DOJ had publicly charged...more
On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest...more
The Department of Justice (DOJ) announced on January 12, 2021, the first civil settlement to resolve allegations of fraud against the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief, and Economic Security...more
Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related...more
8/28/2020
/ CARES Act ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Litigation Funding ,
Multidistrict Litigation ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Relators ,
SBA Lending Programs ,
The Granston Memo ,
Trump Administration
Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more
1/13/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Statistical Analysis
On June 16, 2016, the Supreme Court of the United States rendered a unanimous decision in the highly anticipated False Claims Act (“FCA”) case of Universal Health Services, Inc. v. United States ex rel. Escobar.[1] In its...more
On April 18, 2016, the Office of Inspector General (“OIG”) of the Department of Health and Human Services issued a revised policy statement applicable to exclusions imposed under Section 1128(b)(7) of the Social Security Act...more
On August 3, 2015, in United States ex rel. Kane v. Healthfirst, Inc., et al., No. 1:11-cv-02325 (S.D.N.Y. Aug. 3, 2015), the United States District Court for the Southern District of New York issued the first reported...more
On Nov. 20, 2014, the U.S. Department of Justice (“DOJ”) announced settlements and judgments for False Claims Act (“FCA”) cases totaling $5.7 billion (compared to $3.8 billion in fiscal year 2013), $2.3 billion of which was...more
12/12/2014
/ Affordable Care Act ,
Anti-Kickback Statute ,
Anti-Retaliation Provisions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Overpayment ,
Popular ,
Retaliation ,
Settlement ,
Whistleblowers
Especially in the District of Columbia Circuit, the home base for many fraud cases in which the government is opposed to health care providers and defense contractors, there had been considerable doubt that the...more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more
6/7/2014
/ Certiorari ,
Dismissals ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Off-Label Use ,
Pharmaceutical Industry ,
Pleading Standards ,
Popular ,
Qui Tam ,
Rule 9(b) ,
SCOTUS ,
Split of Authority ,
Takeda Pharmaceuticals ,
Whistleblowers
On March 15, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released the Updated OIG Guidelines for Evaluating State False Claims Acts (“2013 Guidelines”), which replaces the...more