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
The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...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
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...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
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business...more
The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...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
Volumes have been written about the False Claims Act as a tool to pursue fraud against the government in circumstances where the defendant has allegedly made false statements to receive money from the government. For...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
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
A nationwide telemedicine kickback scheme led to fraudulent Medicare reimbursements for durable medical equipment and genetic testing. The full Department of Justice press release can be found here... ...more
DOJ announced a False Claims Act settlement with Universal Health (“UHS”) and related companies for $122 million for billing for medically unnecessary inpatient behavioral health services, failing to provide adequate services...more
Compliance Today (March 2020) - In January, Assistant Attorney General Jody Hunt of the U.S. Department of Justice’s Civil Division announced that it “obtained more than $3 billion in settlements and judgments from civil...more
The Department of Justice (DOJ) recently released its report detailing the settlements and judgments obtained in 2019 from civil cases involving fraud and abuse claims. As in years past, the substantial majority of these...more
The Department of Health and Human Services (DHHS) Office of Inspector General (OIG) announced yesterday a revamped hotline for reporting fraud, waste, abuse and mismanagement involving DHHS programs. ...more
Podiatrist Sentenced to Prison for Fraudulent Billing Scheme - On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more
Over the past year, we have seen a new trend in healthcare fraud cases in which the government has chosen to target private equity firms (PEFs). Traditionally, the government has chosen to name the healthcare company and its...more
In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
If you’re a surgical device distributor and you want to reward a surgeon for using your products on Medicare and Medicaid patients, you may want to choose a reward that’s less conspicuous than a yacht. That’s one lesson in...more