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 ...
The technology to “print” three dimensional objects with a 3D printer is not new, but as prices for the technology fall it becomes more readily available for private individuals. The possibilities that open up when individuals get access to 3D printers trigger the imagination, but the accompanying issues are not without complications. The technology, and the new areas of use to which it is put, also raises many questions, particularly regarding intellectual property rights ...
The BBC recently published a piece called ‘3D Printing Will Be the Next Big Copyright Fight’. It said this: ‘That moment we’ve been hearing about for years – the one where futuristic-sounding 3D printing becomes ubiquitous – is actually upon us.’ It dealt with a topic that’s also referred to as ‘additive manufacturing’ ...
The Site Report has extensively discussed the developments of 3-D printing building construction and its impact on the construction industry. 3-D printing structures is becoming more commonplace. Last month, Iowa State University began designing 3-D printed housing for rural Iowa. ICON Technology, Inc., an Austin, Texas company, is currently planning to build an entire subdivision in Texas using its 3-D printing technology ...
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 ...
You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact ...
Amid the unprecedented changes wracking the business world in 2020, one certainty remains: many industries will look very different in future years as strategic responses to COVID-19 gain traction and become permanent. In the healthcare REIT sector, we are beginning to see trends that may shape industry norms long after the dust has settled from the chaos of 2020. 1 ...
The impact of COVID-19 and the economic downturn has pressured independent hospitals, rural hospitals and smaller health systems in particular. Despite the immense challenges, independent facilities and their Boards should take this time to best position for the near- and long-term. In light of this, Waller partnered with Kaufman Hall to develop a guide for healthcare leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...
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 ...
At the forefront of digital revolutionisation Malaysia has launched the DE Rantau programme aimed specifically towards the digital nomad. The programme was launched on 1 October 2022 and all applications received will be screened by the Malaysia Digital Economy Corporation (“MDEC”). Click here to read more. Should you have any enquiries, please contact Suganthi Singam at [email protected] or Chui Siew Xuan at [email protected] ...
With the COP26 climate summit taking place in Glasgow this week, we thought it would be timely to look at the practical challenges facing businesses wishing to reduce their emissions and become sustainable in alignment with the government’s net zero strategy. Setting targets is crucial for companies with complexity across sectors, technologies and business structures ...
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 ...
Clients unfamiliar with patent prosecution are often surprised to learn that few patent applications receive a first-action allowance, or FAA. There are even rankings of law firms that receive the most FAAs each year. But what does an FAA signify? Is it a cause to celebrate, or to conduct a post-mortem? The answer is, of course, “it depends ...
Several significant changes to the UAE Civil Procedure Law (Federal Law No. 11 of 1992 as amended) came into effect in February this year. An overview of these changes, brought about by Regulations promulgated pursuant to Decree by Law No 10 of 2017 and Cabinet Resolution No. 57 of 2018 (the Regulations) can be found in our inBrief of 12 February 2019 ...
On October 20th, the federal government released a final rule and other companion releases relating to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP), a key component of the Affordable Care Act enacted in March 2010. The proposed rule, issued in March 2011, generated extensive comment from the healthcare industry ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
In July 2021, new private law cases received by Cafcass (the Children and Family Court Advisory Support Service) fell by over 16%. According to the latest figures published by Cafcass this week, they received a total of 3,774 new private law cases in July 2021, 740 cases (16.4%) fewer than in July 2020. Private law cases generally consist of applications made to the family court by a parent or carer of a child following a divorce or separation ...
Ransomware has wreaked so much havoc in recent years that many people forget about other cybersecurity risks. For some, not storing personal information makes them feeling immune to hackers and cyber incidents. For others, as long as their computers are woring, they do not feel exposed to no malware. Unfortunately, the reality is quite different ...
