As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
There were big changes in 2020 in the world of restructuring and insolvency legislation with the introduction of two new restructuring tools: the Moratorium and the Restructuring Plan, as well as the reintroduction of Crown preference. However, due to the government-imposed moratorium while the pandemic runs its course, we have seen hardly any real effects of those reforms ...
The outlook for the year ahead is uncertain with the effects of post-Brexit rules to contend with and COVID-19 continuing to restrict the way we live and work. We look at what the year may have in store for the construction industry. COVID-19 There is no doubt that the pandemic has caused challenges for the construction industry and is likely to have a significant impact into 2021 ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) has just published the SyCipLaw TMT and Data Bulletin covering significant Philippine legal and regulatory developments in the technology, media, telecommunications and data space, from late 2022 to the first quarter of 2023. It also notes links to podcasts and materials relating to TMT and dataPLUSa commentary on whether AI can replace a local counsel ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
The U.S. Court of Appeals for the Second Circuit on March 13 issued a highly consequential decision in U.S. Securities andExchange Commission v. Rashid, interpreting and applying the mental state for liability of investment advisers under the Investment Advisers Act. Over a strong dissent, the court reversed a finding of liability of the defendant investment adviser under basic principles of negligence law, and in doing so, provided a road map for future enforcement actions under the act ...
On Aug. 31, 2012, the United States Court of Appeals for the Second Circuit issued its decision in In re Charter Communications Inc., (2d Cir. Aug. 31, 2012), expressly adopting an abuse of discretion standard for reviewing equitable mootness determinations ...
The glacial pace at which the federal government has implemented cannabis policy–particularly in light of the rapid evolution of cannabis laws at the state level–is at the same time predictable and frustrating to those seeking a measure of certainty ...
When not conducted carefully, internal investigations cancause more harm than good. Deciding to investigate a suspected problem is onlythe first of several key determinations. The responsible executive must planand execute the investigation deliberately to avoid self-inflicted harm. Anorganization can protect itself—while still conducting an investigation that isconfidential, full and fair—only by carefully thinking about how best touncover the alleged wrongdoing or compliance issues ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
In the recent decision of Abdul Malek Bin Mohamed v MISC Bhd dated 17 June 2020 [Award 840 of 2020], the Industrial Court recognised that the tenure of service of an employee in an organisation does not shield the employee from having to render satisfactory performance at the level required by the Company. The Industrial Court upheld the dismissal of an employee for poor performance after 32 years of service ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
In 2020, the U.S. Court of Appeals for the Federal Circuit, the U.S. Court of Federal Claims, and the U.S. Government Accountability Office issued five decisions worthy of particular note: Inserso Corp. v. U.S.[1] Teledyne Brown Engineering Inc.[2] Kiewit Infrastructure West Co. v. U.S.[3] LAX Electronics Inc. v. U.S.[4] Centerra Integrated Facilities Services LLC ...
In United States v. United States ex rel. Thrower, No. 18-16408, on November 14, a panel of the Ninth Circuit gave a skeptical reception to the Department of Justice (DOJ) argument that the district court’s denial of the government’s motion to dismiss a False Claims Act (FCA) qui tam complaint against Academy Mortgage Corporation (Academy) invaded the government’s “prosecutorial discretion ...
What is litigation funding and why is it attractive? Also known as legal finance or litigation finance, third party funding – historically – was considered an improper or corrupting influence on litigation. These old offences of champerty and maintenance were first decriminalised in England in 1967 ...
By: Stephen Best, Clayton Barnett, and Brian Adkins August 27, 2024 Introduction As many sports lawyers are aware, there have already been several examples of name, image, and likeliness (“NIL”) litigation throughout the country. In fact, we previously reviewed several groundbreaking cases which stood to fundamentally alter the landscape of college athletics ...
Whether you are a business pushing out an edgy ad campaign, or one with an unsolicited media crisis on your hands, in the age of the Internet you are just keystrokes away from things going “viral”. It is important to be prepared. Like many bad ideas, it started innocuously enough. In late November, Dolce & Gabbana uploaded a series of videos on its social media platforms that starred a young Chinese woman wearing a red sequin dress ...
Pennsylvania law suggests construction defects generally are not considered an "occurrence" under most CGL insurance policies because defects are not true accidents, e.g., a fortuitous event. However, an exception generally exists for products-related claims as opposed to pure defect claims ...
Regional Labor Court Mecklenburg-Vorpommern, ruling of July 30, 2019, 5 Sa 233/18 It is up to the employer to decide how to react to a conflict situation in the company, regardless of the causes and responsibilities of the disputants. FACTS The parties dispute over the validity of transferring the plaintiff to another workplace to resolve an interpersonal conflict ...
