On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare until September 30, 2025. These were originally scheduled to end...more
In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more
Massachusetts has expanded regulatory oversight of health care transactions by imposing False Claims Act liability on health care owners and investors for changes including failure to disclose violations. On January 8, 2025,...more
Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura...more
On December 6, 2024, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) released the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2023 (the Report). The Report...more
12/18/2024
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Investigations ,
Medicaid ,
Medicare ,
OIG ,
Private Equity ,
Telemedicine
On August 1, 2024, the Department of Justice (DOJ) issued final guidance on its Corporate Whistleblower Awards Pilot Program (Program), offering financial incentives to qualifying individuals who report certain criminal...more
8/8/2024
/ Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Internal Investigations ,
New Guidance ,
Pilot Programs ,
Qui Tam ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical...more
On April 19, 2024, the Department of Education released final Title IX regulations. The significant revisions expand the definition of sexual harassment, attempt to remove barriers to reporting sexual harassment and extend...more
4/24/2024
/ Department of Education ,
Educational Institutions ,
Gender Identity ,
Gender-Based Violence ,
New Regulations ,
Regulatory Reform ,
Sex Discrimination ,
Sexual Harassment ,
Sexual Orientation Discrimination ,
Sexual Violence Policies ,
Students ,
Title IX
On March 7, 2024, Deputy Attorney General (DAG) Lisa Monaco announced the contours of a new Department of Justice (DOJ) pilot program (Pilot) offering financial incentives to individual whistleblowers who report certain...more
On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in the highest-profile False Claims Act (FCA) case for many years, concluding that a party’s subjective belief as to whether it overcharged Medicare and...more
6/2/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The U.S. Department of Justice (DOJ) recently announced several new policies and programs aimed at incentivizing corporate compliance. These programs underscore the need for companies to investigate, mitigate and resolve...more
A recent federal court Title IX decision could affect private and independent schools nationwide. In Buttner-Hartsoe v. Balt. Lutheran High Sch. Ass’n, No. RDB-20-3229 (D. Md. July 21, 2022), five women brought a Title IX...more
Last month, a federal court in North Carolina held in Karanik et al. v. Cape Fear Academy, Inc., No. 7:21- CV-169D (E.D.N.C.June 17, 2022), that a private secondary school’s receipt of a Paycheck Protection Program (PPP) loan...more
7/19/2022
/ CARES Act ,
Coronavirus/COVID-19 ,
Federal Jurisdiction ,
Financial Assistance Policies ,
Gender-Based Violence ,
Infectious Diseases ,
Paycheck Protection Program (PPP) ,
Private Schools ,
Relief Measures ,
Sexual Assault ,
Sexual Harassment ,
Sexual Violence Policies ,
Title IX
What To Do When The Government Knocks On Your Lab’s Door -
The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
7/15/2022
/ Clinical Laboratories ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Price Transparency ,
Virus Testing
On June 23, 2022, the 50th anniversary of the passage of Title IX, the Department of Education (DOE) released proposed major changes to the current Title IX regulations made effective in August 2020. The proposed revisions...more
6/28/2022
/ Biden Administration ,
Department of Education ,
Disciplinary Proceedings ,
Educational Institutions ,
Gender Identity ,
Gender-Based Violence ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Sexual Assault ,
Sexual Harassment ,
Sexual Orientation Discrimination ,
Sexual Violence Policies ,
Students ,
Title IX
Nearly forty-five years after its decision in Regents of the University of California v. Bakke, the Supreme Court appears poised to overturn or significantly depart from its prior approval of the use of race as a “plus...more
4/13/2022
/ Affirmative Action ,
Case Consolidation ,
Certiorari ,
Civil Rights Act ,
College Admissions ,
Colleges ,
Diversity ,
Harvard University ,
Race Discrimination ,
SCOTUS ,
Statutory Violations ,
Students ,
Title VI ,
Universities ,
University of Texas
CYBERSECURITY -
Another Win for Justice Department: Slilpp Marketplace Takedown -
People always ask me if law enforcement is having any luck in combatting cyber criminals. Let me be clear: it is a very tough job to take...more
6/18/2021
/ Ancestry.com ,
Beyond Visual Line Of Sight (BVLOS) ,
Car Rentals ,
Computer Fraud and Abuse Act (CFAA) ,
Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Department of Justice (DOJ) ,
Drones ,
Enforcement Actions ,
Federal Aviation Administration (FAA) ,
Hackers ,
Popular ,
Ransomware ,
SCOTUS ,
Van Buren v United States
On June 3, 2021, the U.S. Supreme Court issued its first-ever interpretation of the Computer Fraud and Abuse Act (CFAA), the federal criminal and civil statute intended to deter and punish unauthorized access to computer...more
Last month, the president signed Executive Order 14021, directing the Department of Education (DOE) to review the Trump administration’s controversial Title IX regulations and provide findings within 100 days. As we noted in...more
During the presidential campaign, President Biden indicated that he would revive Obama-era guidance to schools on how to investigate sexual harassment and assault under Title IX, including the 2011 “Dear Colleague Letter”...more
3/9/2021
/ Anti-Discrimination Policies ,
Biden Administration ,
Colleges ,
Disciplinary Proceedings ,
Educational Institutions ,
Gender-Based Violence ,
LGBTQ ,
Regulatory Oversight ,
Regulatory Reform ,
Sex Discrimination ,
Sexual Assault ,
Sexual Harassment ,
Sexual Violence Policies ,
Students ,
Title IX ,
Universities
CYBERSECURITY -
NYDFS -
Cybersecurity Certificate of Compliance Due April 15, 2021
The New York Department of Financial Services (DFS), which regulates certain covered entities and licensed persons in the financial...more
1/22/2021
/ Blockchain ,
California Consumer Privacy Act (CCPA) ,
CARES Act ,
Class Action ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Financial Services Industry ,
Hackers ,
HIPAA Breach ,
Malware ,
Marriott ,
NYDFS ,
Paycheck Protection Program (PPP) ,
Personal Data ,
Personally Identifiable Information ,
Russia ,
SolarWinds ,
Vaccinations
The U.S. Attorney’s Office for the District of Massachusetts is warning small businesses that received loans through the Paycheck Protection Program (PPP) of a dramatic increase in reports of business email-compromise schemes...more