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
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
Examine a major Ninth Circuit decision affirming dismissal of a Section 14(a) derivative action based on a forum-selection clause; Highlight the Third Circuit’s adoption of the Omnicare standard for securities fraud claims;...more
Strike 3 Holding, LLC is a prolific filer of federal copyright infringement actions. They have filed thousands of lawsuits across the United States in states like Illinois, Pennsylvania, New Jersey, New York, Florida, Texas...more
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more
President Joe Biden signed into law the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (2023 NDAA or Defense Bill) on Dec. 23, 2022. The Defense Bill, which passed the U.S. House of Representatives on...more
As we enter the third year of the pandemic, life with COVID-19 has become the new “normal” for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
The Illinois Biometric Information Privacy Act (BIPA 740 ILCS 14/1 et seq.) requires businesses to notify individuals before collecting their biometric identifiers such as fingerprints (click here to read our previous client...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more
On January 14, the Federal Aviation Administration approved the first fully automated commercial drone flights by granting Massachusetts-based American Robotics, Inc. permission to operate drones without hands-on piloting and...more
On July 15, 2020, the IRS issued interim guidance (IG) providing instructions to examiners on how to inform churches of the option to authorize the Service to consider church claims for refund or requests for abatement...more
IRS Notice 2020-51, released last week, provides additional guidance on the waiver in 2020 of required minimum distributions (RMDs) from defined contribution retirement plans and IRAs, and the interaction of this waiver with...more
In the event of a national disaster or emergency under the Stafford Act or the National Emergencies Act and a Public Health Emergency Declaration by government officials, the Department of Health and Human Services (HHS)...more
On June 4, 2020, the IRS released Notice 2020-39, which provides five key relief provisions for qualified opportunity funds (QOFs) and their investors in response to the ongoing COVID-19 pandemic: •Extends the time period...more
In response to the COVID-19 pandemic, on March 17, 2020, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) issued a notification of enforcement discretion, announcing that it would not...more
The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
If 2018 was a year of elevator music at the National Labor Relations Board, 2019 was symphony of sound. The Board’s initiatives were varied, high-profile and in the vast majority of cases, the developments were positives for...more
I’m not a fan of reporting legislation, but this piqued my interest. Sen. Pat Toomey (R-PA), a member of the Senate Finance Committee, is working on a bill that would allow plan participants to withdraw funds from their...more
Multi-state coalition’s lawsuit challenges Trump EPA withdrawal of California Clean Air Act waiver. EPA formally announced its decision to withdraw California’s 2013 Clean Air Act waiver, which allowed the state to set its...more
With cybercrime on the rise, organizations have increasingly found themselves subject to litigation or regulatory investigations related to breaches. Documents and information created before breaches, such as security...more
Protection of industrial control systems is crucial to the security of our country. The National Cybersecurity Center of Excellence (NCCoE) has announced a project for which it is seeking comment: Detecting and Protecting...more
On May 8, 2019, following Iran's announcement that it intends to suspend certain nuclear proliferation-related commitments under the Joint Comprehensive Plan of Action (JCPOA), the United States issued a new Executive order...more
Health care issues will remain a central focus in Washington throughout 2019. Having gained control of the House following the 2018 mid-term elections, Democrats now have the ability to block President Trump's legislative...more
On December 10, 2018, the California Supreme Court unanimously held in Gerard v. Orange Coast Memorial Medical Hospital that section 11(D) of Industrial Welfare Commission (“IWC”) Wage Order No. 5, which permits health care...more