Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (PHE) on May 11, 2023. The PHE has been in place for over three years during which time many telehealth and...more
New Congressional Research Service Reports Explain “Holman Rule” By a 220 – 213 essentially party-line vote, the U.S. House of Representatives passed its procedural rules package (H.Res.5) that includes the “Holman Rule.”...more
The Department of Justice (DOJ) announced on September 12, the first-ever False Claims Act (FCA) settlement with a Paycheck Protection Program (PPP) lender. Prosperity Bank, a Texas-based regional bank, agreed to pay...more
Last week, the EDNY and the DOJ Consumer Protection Branch brought a civil enforcement action against defendants who manufacture and sell an herbal tea product called B4B Earth Tea Extra Strength (“Earth Tea”). Earth Tea...more
The U.S. Department of Justice (DOJ) recovered more than $5.6 billion in civil False Claims Act (FCA) judgments and settlements in fiscal year (FY) 2021, the second largest ever annual total in FCA recoveries and the largest...more
The initial effective date of June 4, 2021, for New York’s HERO Act (“HERO”) is rapidly approaching, and soon all employers in New York will be required to adopt and implement model airborne infectious disease standards to be...more
There can be little doubt that the FAA is no longer going to tolerate the disruptions caused by drunken and unruly passengers. Yesterday, the FAA announced large civil penalties against another four travelers for misconduct...more
SCOTUS: No Equitable Monetary Relief for FTC Under § 13(b) - Well, the buck stops here (for now). In AMG Capital Management, LLC v. Federal Trade Commission, the Supreme Court unanimously ruled that Section 13(b) of the...more
The Financial Institutions Reform, Recovery and Enforcement Act of 1989 (“FIRREA”) is a powerful tool in the prosecutorial arsenal. Due to its long statute of limitations, expansive penalty provision, and low civil burden of...more
On January 21, 2021, President Biden signed an Executive Order on Promoting COVID-19 Safety in Domestic and International Travel, which mandated mask wearing on all commercial aircraft. In addition, all domestic United...more
Recently, the Beverly Hills Bar Association in California sponsored a panel presentation on “PPP Enforcement Trends,” whose panelists included a high-level prosecutor from the United States Attorney’s Office and other leading...more
2020 saw continuity in CFTC leadership, programs, and direction from 2019. Overall, the Commission enjoyed an unusually heavy rulemaking calendar and continued the direction of its enforcement program from 2019. On the...more
Report on Medicare Compliance 30, no. 7 (February 22, 2021) - A Michigan woman is the first in the nation to be charged criminally with misappropriating money from the Provider Relief Fund (PRF), the Department of Justice...more
In Washington: The Labor Department on Thursday adjusted last week’s jobless claims numbers upward, showing claims surged to a seasonally adjusted 861,000, a sign that the labor market continues to struggle to recover from...more
On January 14, 2021, the United States Department of Justice (“DOJ”) issued its annual press release highlighting its recoveries from False Claims Act (“FCA”) enforcement over the last fiscal year. Total recoveries in FY2020...more
In its first enforcement action against a public company for misleading disclosures regarding COVID-19’s business impact, the SEC released a December 4 Order Instituting Proceedings against The Cheesecake Factory Inc. and...more
In the News. The Securities and Exchange Commission (SEC) announced that it adopted Rule 12d1-4 under the Investment Company Act of 1940 (the 1940 Act), providing a new regulatory framework for fund-of-funds and final...more
The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has now issued its second set of coronavirus-related citations, this time against an Ohio health-care company. OSHA inspected three of the...more
The U.S. Department of Transportation (DOT) recently issued a consent order assessing a $70,000 civil penalty against Volaris, the Mexican low-cost airline, for alleged violations of DOT’s regulations governing lengthy tarmac...more
Alleging that a Florida company fabricated a pair of press releases to create the false impression of having contracts to supply N95 masks to health care providers, the Securities and Exchange Commission filed suit seeking...more
- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...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
Through the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the federal government has passed an emergency stimulus package that will result in an unprecedented US$2 trillion infusion into the private and...more