After 35 days of the government shutdown, one of the (many) issues currently facing companies who contract with government agencies affected by the shutdown is if, when, and how, they must pay their employees upon the reopening of the government. Continue Reading
The United States District Court of the Eastern District of Pennsylvania recently issued a decision unsealing a False Claims Act case over the objections of the government, the relator and the defendant. In United States ex. Rel. Brasher v. Pentec Health, Inc. No. 13-05745, 2018 WL 5003474 (E.D.P.A. Oct. 16, 2018), a case initially filed five years ago, the government filed a motion to continue the seal – which happened to be its eleventh such motion – arguing that additional time was necessary, in part, to finalize its decision whether to intervene in the action, as well as to pursue settlement options. The Court disagreed. Continue Reading
On January 22, 2019, the Financial Industry Regulatory Authority, Inc. (“FINRA”) released its annual priorities letter highlighting its regulatory program’s points of emphasis for the coming year. The most immediately recognizable difference between this year’s edition and previous ones is that its traditional title, “Examination Priorities,” has been updated to include “Risk Monitoring,” the process by which the self-regulatory organization initially identifies problem areas through surveillance, firm reporting, surveys, questionnaires, and examination findings.
FINRA’s 2019 “Risk Monitoring and Examination Priorities Letter” (the “Letter”) also discusses three entirely new priorities: online distribution platforms, fixed income mark-up disclosure, and regulatory technology. Finally, the Letter lists ongoing areas of focus, and alerts firms that it will continue to assess protocols to handle the risks posed by “bad actors” with problematic regulatory histories. Continue Reading
The Defense Health Agency (DHA), which manages the TRICARE health care benefits, has issued a Request for Information (RFI) regarding inpatient-clinic administered pharmaceuticals formulary management. In other words, responding vendors have the opportunity to shape the standard list of drugs prescribed across all military medical treatment facilities (MTFs), as well as the broader program administering the list. Responses are due February 5, 2019. The RFI seeks commercial best practices in formulary management focusing on inpatient and medical benefit drugs, but also opens the door for responding vendors to describe their capabilities to train a formulary management staff, to develop approaches to formulary management, to compare program results, to maximize acceptance of an implemented program, and to utilize pharmacists in an inpatient setting. Continue Reading
On November 27, 2018, the U.S. Government Accountability Office (“GAO”) released its Bid Protest Annual Report to Congress for Fiscal Year 2018.
Under the Competition in Contracting Act of 1984 (“CICA”), GAO is required to report annually to Congress on each instance in which (1) a federal agency did not fully implement a recommendation made by GAO in connection with a bid protest decision, or (2) a final decision in a protest was not rendered within 100 days after the date the protest was submitted to the Comptroller General, during the prior fiscal year. GAO reported no such instances for Fiscal Year 2018. Continue Reading
The Enforcement Division of the United States Securities and Exchange Commission (“SEC”) recently released its annual enforcement report (“Report”) for fiscal year 2018. The Report reflects an increased focus on retail investors, cryptocurrency, cybercrime, and individual accountability. Further, it showcases that SEC enforcement continues to be robust under the Trump administration, despite industry and media expectations to the contrary.
In fiscal year 2018, the SEC brought 821 enforcement actions, an approximately 8.8% increase from last year. The SEC collected approximately $3.9 billion in monetary penalties, a 4% increase from last year. Notably, however, a significant portion of this amount came from a single case, in which $1.8 billion in disgorgement and penalties were awarded for a large-scale corruption scheme. Moreover, while total monetary penalties rose, there was a decrease in the total amount of disgorgement imposed. This is likely due in part to the Supreme Court’s 2017 Kokesh decision, which held that SEC claims for disgorgement are subject to a five-year statute of limitations. Continue Reading
The 2019 National Defense Authorization Act (“NDAA”) imposes new restrictions on procurements for telecommunications equipment or services based on ties to certain Chinese entities, thereby growing the list of forbidden products for contractors. Specifically, Section 889 prohibits executive-branch agencies from initiating procurements or entering into contracts for certain telecommunications equipment or services from companies associated with, owned, or controlled by the People’s Republic of China, that are to be used “as a substantial or essential component of any system, or as critical technology as part of any system.” Continue Reading
In the aftermath of the Securities and Exchange Commission’s (“SEC”) latest Report of Investigation (“Report”) regarding cyberattacks via “spoofed or manipulated electronic communications,” companies should prepare to adjust and update their internal controls or face possible enforcement actions for violation of federal securities law. Released as a warning to public companies about recent cyberattacks, the Report’s emphasis that companies maintain proper internal controls to combat cybersecurity issues indicates SEC enforcement actions for lack of proper cybersecurity procedures and supervision are on the horizon. Continue Reading
As the Democrats in Washington prepare to assume control of the House of Representatives following the 2018 midterm elections, “pundits” and “experts” are speculating about the Congressional oversight that will occur over the next two years. While it is definitely true that Washington will experience far more – and far more vigorous – Congressional oversight in the next Congress, there is a lot of misinformation out there about what that means, and how it will work. It is important to understand how Congressional oversight works. The following are seven key myths regarding Congressional oversight: Continue Reading
On October 24, 2018, President Trump signed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT Act”) into law (See, “Congress Passes ‘SUPPORT for Patients and Communities Act’ – A Rare Example of Bi-Partisanship” Sheppard Mullin Healthcare Law Blog, October 12, 2018). The SUPPORT Act is wide-ranging legislation comprised of over 120 separate bills aimed at combatting the opioid crisis and impacting every corner of the healthcare continuum. Continue Reading