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
On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on...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
Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...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
This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more
Binance to Pay Historic $4 Billion Fine - Binance Holdings Limited, the operator of the world’s largest cryptocurrency exchange, agreed to pay $4.3 billion to resolve allegations that it violated the Bank Secrecy Act (BSA)...more
Harris Beach invites you to register for its 7 Element compliance program series addressing New York’s 2020 and 2022 updates to Medicaid Compliance Program requirements. Starting on August 16th, each live program will be no...more
On July 20, 2022, the Department of Justice announced charges against 36 criminal defendants across 13 different federal districts for healthcare fraud violations resulting in Government losses in excess of $1.2 billion. The...more
The following is a summary of the federal Health and Human Services agency’s Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are based...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - Medtronic USA Inc., a medical device maker, has agreed to pay $8.1 million to settle allegations it violated the False Claims Act by paying kickbacks to induce...more
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more
Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million. The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...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
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
I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more
Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more
David Chandler was appointed to serve as chairman of Tri-Lakes Medical Center (TLMC), a community hospital in Panola County, Mississippi. As chairman, Chandler set board meeting agendas, regularly dealt with the administrator...more
Federal prosecutors recently announced a $12.6 million False Claims Act (FCA) settlement with a major New Jersey health system to resolve allegations that the system paid outside physicians in order to increase referrals....more