The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
A federal district court judge in the Eastern District of Kentucky has enforced an ESOP’s arbitration clause, sending P.L. Marketing Inc. employees’ breach of fiduciary duty claims on behalf of a putative class to individual...more
Delaware Court of Chancery holds contractual waivers of fiduciary duties are facially valid when they are both narrowly tailored to authorize specific transactions and satisfy the Court’s review for reasonableness. Court...more
“The provision of health care services via telemedicine has been growing in popularity over the last several years. With the arrival of the COVID-19 pandemic, healthcare providers were able to rely on a variety of temporary...more
The Eleventh Circuit Court of Appeals has recently clarified the legal standard necessary to strip government officials of their entitlement to statutory immunity. The ruling clarifies the misunderstanding reflected in...more
Arbitration agreements and class-action waivers have been important tools for employers seeking to reduce expense and exposure in cases brought by employees. These legal instruments have begun to be limited, though. ...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
In one of her first official actions as Acting Chair of the Securities and Exchange Commission (SEC or Commission), Allison Herren Lee reversed a major policy implemented by recently departed SEC Chairman Jay Clayton...more
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more
In an effort to flatten New York State’s infection and hospitalization rate due to the COVID-19 pandemic, Governor Cuomo signed an executive order in March 2020, mandating statewide lockdown measures. Those measures appear...more
For the first 72 hours after a hospital institutes its disaster protocol for the COVID-19 emergency, HIPAA sanctions and penalties will be waived for: - Failure to obtain a patient’s agreement to speak with family/friends...more
Topics to be presented: HIPAA, Telehealth, and Other Compliance Flexibilities Presented by Patricia A. Markus Stark Waivers and Medicare Advance Payments Presented by Lester J. Perling Compliance and Enforcement ...more
Amid the economic shocks caused by the Coronavirus (COVID-19) crisis, many industries are facing reduced demand for their products and services. Other industries—notably healthcare and food—are adjusting rapidly to expanding...more
The CFPB published for comment in today’s Federal Register a proposed policy on issuing “no-action” letters for innovative financial products or services. Like those issued by the SEC and CFTC, the no-action letters would...more
Introduction - In a recent award enforcement decision, the US Court of Appeals for the Ninth Circuit ruled that parties cannot contractually eliminate judicial review of arbitral awards under the US Federal Arbitration...more
Mandatory arbitration provisions are not always enforced....more