HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...more
Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more
The U.S. Department of Justice (DOJ) announced in a Nov. 12, 2024, press release that an ophthalmology practice with offices located in West Central Florida (the Provider) entered into an approximately $1.3 million settlement...more
As value-based care (VBC) models continue to grow across our nation’s health system and specifically within different specialties like nephrology, the costs and challenges of maintaining these models continue to rise. In...more
The U.S. Department of Justice (DOJ) announced recently that settlements and judgments under the False Claims Act, 31 U.S.C. § 3729, et seq. (FCA) totaled approximately $2.7 billion in FY 2023 (October 1, 2022 – September 30,...more
Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more
Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...more
The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for...more
A recent U.S. District Court decision provides a good example of how federal courts will apply the public disclosure/original source rules in whistleblower cases alleging that health care providers violated the False Claims...more
On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more
SCOTUS Denies Cert In Cases Addressing FCA Pleadings Requirements - On Monday, October 17, 2022, the US Supreme Court rejected three petitions asking the Court to resolve a circuit split regarding the Rule 9(b)...more
The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers....more
This is the seventh post in this year’s series examining important trends in white collar law and investigations. Our previous post discussed SEC Enforcement in 2022: A Look Ahead. Up next: ESG and the SEC: What’s Next on the...more
The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more
On February 1, the U.S. Department of Justice (DOJ) announced the second-largest annual total recoveries in the history of the False Claims Act (FCA)—$5.6 billion—for FY 2021 (October 2020 – September 2021)...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of...more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more
Seyfarth Synopsis: The United States Department of Justice recently filed a seismic motion to dismiss in a series of healthcare fraud-related cases. ...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Healthcare Management Associates (HMA) settled criminal and civil charges with the Justice Department for illegal fraud and kickback schemes. HMA billed federal government healthcare programs for inpatient services that...more
Operating in the long term care (LTC) industry is undoubtedly challenging. On top of limited reimbursement from government payors, there are stringent regulations, surveys and other forms of regulatory scrutiny, malpractice...more
In February, the Department of Justice (DOJ) intervened in a False Claims Act case alleging healthcare fraud, a common enough event. The case in question, originally began in 2015 as a whistleblower case brought by two...more