At the American Bar Association’s 39th National Institute on White Collar Crime on March 7, U.S. Deputy Attorney General Lisa Monaco provided updates on criminal enforcement efforts and announced new Department of Justice initiatives, including a new whistleblower program.
Latest from The FCA Insider - Page 6
Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by misleading the FDA regarding the intended use of the device. In
OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued its General Compliance Program Guidance for healthcare providers and other industry stakeholders. The guidance follows OIG’s previous announcement about a modernization initiative
Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models
The U.S. Department of Health and Human Services Office of Inspector General recently issued Advisory Opinion 23-08, continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute and
A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?
This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statute (AKS). In filing a motion for
The Growing Causal Divide: But-For Causation in AKS/FCA Actions
In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to
$12M Default Judgment Results from Purchasing Prescriptions
A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case.
In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal), in the
Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship Allegations
Two ophthalmology practice groups recently reached settlements with the U.S. government totaling nearly $20 million to resolve allegations that their third-party cataract arrangements violated several healthcare laws.
Read on to discover how the settlements offer guidance to vision providers with
HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees
On Oct. 13, the U.S. Department of Health and Human Services Office of Inspector General issued an advisory opinion approving a physician practice’s proposal to pay bonuses to each of its employed physicians based on net profits derived from the
DOJ Settles Self-Reported Referral Incentives With Dermatology Practice Manager
On Sept. 13, the U.S. Attorney’s Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC to resolve self-reported allegations that its acquisition of several dermatology practices violated the Stark Law, the Anti-Kickback Statute