Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more
3/28/2025
/ Constitutional Challenges ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Penalties ,
Treble Damages
The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
While hospitals will no longer be formally considered sensitive locations under new immigration directives, health care facilities and providers maintain responsibility to protect access to patient care and confidentiality....more
1/27/2025
/ Data Privacy ,
Department of Homeland Security (DHS) ,
EMTALA ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Immigration and Customs Enforcement (ICE) ,
Immigration Enforcement ,
Patient Access ,
Patient Privacy Rights
New York recently passed new cybersecurity regulations for hospitals licensed in New York to enhance patient safety and cybersecurity....more
11/7/2024
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Information Technology ,
New Legislation ,
New York ,
Personally Identifiable Information ,
PHI ,
Regulatory Reform
In a potentially seismic development, a federal district court held that the False Claims Act's qui tam provisions violate the Constitution's Appointments Clause—a ruling that, if upheld, would upend the landscape of FCA...more
The Development: On August 1, 2024, the Department of Justice's ("DOJ") Criminal Division announced its Corporate Whistleblower Awards Pilot Program ("Pilot Program"), designed to reward whistleblowers who report information...more
8/20/2024
/ CFTC ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Financial Crimes ,
Financial Institutions ,
FinCEN ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare Fraud ,
Money Laundering ,
Pilot Programs ,
Securities and Exchange Commission (SEC) ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
The Situation: The False Claims Act ("FCA") imposes treble damages on defendants, as well as mandatory penalties per false claim. Because alleged false claims often involve much smaller amounts—for example, in cases with a...more
8/19/2024
/ Corporate Counsel ,
Due Process ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Treble Damages
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral for an item or service reimbursable by a...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
4/8/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more
4/1/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
DOJ, FTC, and HHS jointly announced the launching of a cross-government public inquiry into increasing private equity and corporate involvement in health care, the latest announcement in a string of public statements from the...more
Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more
3/4/2024
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Qui Tam ,
Settlement ,
Whistleblowers ,
White Collar Crimes
The Background: In August 2022, the United States Court of Appeals for the Second Circuit held in Murray v. UBS Securities, LLC., et al. ("Murray") that an employee suing his employer under the anti-retaliation provisions of...more
2/19/2024
/ Adverse Employment Action ,
Anti-Retaliation Provisions ,
Burden of Proof ,
Certiorari ,
Employees ,
Employer Liability Issues ,
Murray v UBS Securities LLC ,
Retaliation ,
Sarbanes-Oxley ,
SCOTUS ,
Whistleblower Protection Policies ,
Whistleblowers
The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more
2/19/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Popular ,
Proposed Regulation ,
Public Health
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more
11/28/2023
/ Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Scientific Evidence ,
Scientific Research
In light of the DOJ’s most recent guidance on the use of personal devices and third-party messaging applications by corporate personnel, this White Paper addresses issues and challenges that companies are facing in this area...more
10/18/2023
/ CFTC ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Department of Justice (DOJ) ,
Electronic Communications ,
Financial Industry Regulatory Authority (FINRA) ,
Guidance Update ,
Instant Messaging Apps ,
Mobile Devices ,
Policies and Procedures ,
Securities and Exchange Commission (SEC) ,
White Collar Crimes ,
Workplace Communication
The Consumer Financial Protection Bureau (“CFPB”), Department of Health and Human Services (“HHS”), and United States Treasury have issued an interagency Request for Information (“RFI”) focused on the offering and provision...more
The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more
The False Claims Act's ("FCA") use of qui tam relators (private individuals bringing suit on behalf of the government) has long raised both procedural and substantive challenges....more
The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
The decision should prove helpful for those in the health care and life sciences industries whose daily operations require compliance with the federal Anti-Kickback Statute ("AKS")....more
In Short -
The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...more
In Short: -
The Situation: The United States Department of Justice ("DOJ") recently issued statistics and a related press release regarding its fiscal year ("FY") 2022 enforcement activity under the False Claims Act...more