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
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...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: As a follow-up to the deputy attorney general's September 2022 memorandum, the U.S. Department of Justice ("DOJ" or "Department") announced in March 2023 significant updates to its corporate...more
On February 22, 2023, the U.S. Department of Justice ("DOJ" or "Department") announced the Voluntary Self-Disclosure Policy ("VSD Policy" or "Policy"), detailing the circumstances under which a company can receive credit for...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
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
Note From the Editors -
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 take an in-depth look at...more
The National Institute of Standards and Technology ("NIST") has released its AI Risk Management Framework ("AI RMF") as a resource to reportedly assist individuals, organizations, and society identify risks associated with...more
In Short -
The Situation: On January 17, 2023, the U.S. Department of Justice ("DOJ" or "Department") announced significant revisions to the Criminal Division's Corporate Enforcement Policy....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
Courts and legislatures both in the United States and abroad continue to prioritize the eradication of labor trafficking in corporate supply chains, including those in the health care industry. For example, in the United...more
The Artificial Intelligence Bill of Rights sets forth voluntary guidelines that companies utilizing or developing technology with artificial intelligence can follow to protect users....more
On August 31, 2022, the California Attorney General delivered letters to 30 hospitals and health systems across California requesting information regarding commercial decision-making technology tools and their potential...more
In Short -
The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...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
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
On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...more