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 April 20, 2022, the Department of Justice (DOJ) announced a nationwide coordinated enforcement action targeting COVID-19-related fraud involving charges against 21 individuals across nine federal districts, and over $149...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 April 8, 2021, the U.S. Department of Justice (“DOJ”) announced the first charges brought in connection with alleged fraud on the Accelerated and Advance Payment Program, administered by the Centers for Medicare & Medicaid...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
Advances in artificial intelligence (“AI”) continue to present exciting opportunities to transform decision-making and targeted marketing within the world of consumer products. While AI has been touted for its capabilities in...more
You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more
2/12/2021
/ Algorithms ,
Artificial Intelligence ,
Bias ,
Biometric Information ,
Chief Compliance Officers ,
Chief Information Officers (CIO) ,
Clinical Trials ,
Corporate Counsel ,
Employer Liability Issues ,
FDA Approval ,
Health Care Providers ,
Hiring & Firing ,
Human Resources Professionals ,
Life Sciences ,
Popular ,
Recruitment Policies ,
Risk Mitigation ,
Targeted Digital Advertising ,
Webinars
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 October 14, 2015, the Federal Trade Commission (“FTC”) issued guidance on how state regulatory boards can regulate their professions without running afoul of the antitrust laws (“Guidance”). The Guidance was issued in...more
On September 9, 2015, the Department of Justice (“DOJ”) issued new guidance on individual accountability for corporate wrongdoing. In the memorandum and an accompanying speech by the Deputy Attorney General Sally Q. Yates,...more
9/29/2015
/ Attorney-Client Privilege ,
Board of Directors ,
C-Suite Executives ,
Chief Compliance Officers ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Government Investigations ,
Healthcare ,
New Guidance ,
Yates Memorandum
On August 13, 2015, the Federal Trade Commission (“FTC” or “Commission”), by a 4-1 vote, approved a bipartisan “Statement of Enforcement Principles” (“Statement of Enforcement”),[1] which purports to shed light on the...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 April 20, 2015, the Federal Trade Commission (“FTC”) announced that Cardinal Health, Inc. (“Cardinal”), agreed to pay $26.8 million to resolve allegations that it violated Section 2 of the Sherman Act by monopolizing the...more
On February 24-25, 2015, the Federal Trade Commission (“FTC”) and Antitrust Division of the Department of Justice (“DOJ”) co-hosted a second public workshop as part of the “Examining Health Care Competition” series to study...more
4/15/2015
/ ACOs ,
Affordable Care Act ,
Antitrust Division ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Fee-for-Service ,
Health Care Providers ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare ,
Hospitals
On February 25, 2015, the Supreme Court of the United States held that the North Carolina Dental Board (“Board”) was not insulated from federal antitrust liability under the so-called “state action” doctrine when it engaged...more
On November 7, 2014, the Antitrust Division of the U.S. Department of Justice (“DOJ”) reached a $5 million settlement with Flakeboard America Limited (“Flakeboard”), its foreign parents, and SierraPine to settle allegations...more
1/8/2015
/ Antitrust Provisions ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Disgorgement ,
Due Diligence ,
Enforcement Actions ,
Flakeboard America ,
Gun-Jumping ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Hospitals ,
Sherman Act ,
Waiting Periods
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
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 January 24, 2014, in Federal Trade Commission v. St. Luke's Health System, Ltd. & Saltzer Medical Group, P.A., the U.S. District Court for the District of Idaho found that the acquisition of Saltzer Medical Group...more
On June 30, 2013, the governor of the State of Delaware signed legislation that amends the Delaware General Corporation Law ("DGCL"). Among the amendments are two new sections of the DGCL, Section 204 and Section 205, which...more
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