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 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
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
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
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
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
Last Friday, the Department of Justice (DOJ) secured another trial court conviction in a Foreign Corrupt Practices Act (FCPA) prosecution involving an individual. Following on the heels of the Hoskins guilty verdict, it...more
This week I have been considering the guilty pleas of the former Unaoil Chief Executive Officer (CEO), Cyrus Ahsani, and former Chief Operations Officer (COO), Saman Ahsani, as was laid out in their Information. Most...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
This week I am mining the guilty pleas of the former Unaoil Chief Executive Officer (CEO), Cyrus Ahsani, and former Chief Operations Officer (COO), Saman Ahsani, for what they might mean for Foreign Corrupt Practices Act...more
The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...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
DOJ settlement signals need for enhanced False Claims Act scrutiny. Private funds continue to face heightened secondary liability risks arising from their portfolio investments....more
After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...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
Well, add another pharmaceutical company to the FCPA healthcare “sweep.” Frankly, the term “sweep” makes it sound like a coordinated enforcement effort – instead, it is more accurate to think of it as multiple prosecutions...more
The Department of Justice finished 2017 with two significant FCPA enforcement actions, and fittingly, one was a corporate settlement and another was an individual criminal guilty plea. The Justice Department’s final FCPA...more
You know this has been a big year in FCPA enforcement when DOJ and the SEC announce two FCPA settlements during the usually sleepy week between Christmas and New Years. And what a year it has been – more to follow in my...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
Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more
The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more
In the wreckage of a corporate FCPA enforcement action, a company has to answer two important questions. First, how did the conduct occur without senior executives and the Board learning or suspecting that such conduct...more
On Aug. 12, 2015, Vincente Garcia (former head of Latin American sales for SAP International Inc.) pled guilty in federal court in San Francisco to violations of the Foreign Corrupt Practices Act. In addition to pleading...more
On this date in 2008 George Carlin died. If you grew up in the late 1960s or early 1970s and you had anti-parental or anti-establishment inklings, which of course all teenagers do, you knew about George Carlin. In the early...more