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
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
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
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
11/27/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Privacy ,
Data Security ,
DEA ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Popular ,
Public Health ,
Telehealth
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...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
In a momentous event for False Claims Act cases throughout the country, the Supreme Court has granted certiorari to decide the applicable scienter standard....more
In Short -
The Situation: The federal False Claims Act ("FCA") allows the United States to dismiss the action if the qui tam relator "has been notified by the Government of the filing of the motion and the court has...more
The Situation: The practice of manufacturers making available to customers favorable and even zero-interest financing for significant purchases of medical devices is understood to be common and often expected by customers...more
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more
DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. -
The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more
2/23/2022
/ Anti-Kickback Statute ,
Cyber Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare Advantage ,
Paycheck Protection Program (PPP) ,
Qui Tam
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
2/14/2022
/ False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Liability ,
Qui Tam ,
Regulatory Standards ,
Regulatory Violations ,
Relators ,
Scienter ,
Statutory Interpretation
A defendant who violates the FCA can be liable for treble damages plus a civil penalty of $5,500 to $11,000 (adjusted for inflation) for each false claim. Meanwhile, FCA lawsuits often involve tens of thousands of alleged...more
2/3/2022
/ Civil Monetary Penalty ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Fines ,
Health Care Providers ,
Medicare ,
Qui Tam ,
Reimbursements ,
Relators ,
Statutory Violations ,
Treble Damages