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
Our newsletter reflects the focus of Akin’s cross-practice autonomous systems and advanced mobility team on developments in the regulatory, policy, trade, intellectual property, and cybersecurity and privacy spaces....more
On September 27, 2023, the Department of Homeland Security (DHS) announced the designation of Israel into the Visa Waiver Program (VWP). By November 30, 2023, the Electronic System for Travel Authorization (ESTA) will be...more
The Department of State, in consultation with the Department of Homeland Security, has authorized consular officers to waive the in-person interview requirement for certain non-immigrant visa applicants with approved...more
The U.S. secretary of state, in consultation with the U.S. Department of Homeland Security (DHS), has authorized consular officers to waive in-person interviews for certain nonimmigrant visa applicants through the end of...more
In March, we wrote about how we still were awaiting guidance from the White House about how the Made in America Office’s waiver process would work under President Biden’s January 25, 2021 EO 14005, Ensuring the Future is Made...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
As a follow up to our legal alert posted on April 7, 2020, the Federal Communications Commission ("FCC") announced that it is accepting applications for its $200 million COVID-19 Telehealth Program as of April 13, 2020. As a...more
Update 04.10.2020: The FCC has launched an online portal explaining the application process for grants from the $200 million in funding to support telehealth services described in this client update. The FCC will begin...more
The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more
Recognizing the need to make health services available during the current state of emergency, California Governor Gavin Newsom issued Executive Order N-43-20 (the “Order”) on April 3, 2020. The Order temporarily expands the...more
As we previously reported, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) (“CARES Act”) on March 27, 2020. We recently provided guidance on how the CARES Act...more
As the COVID-19 pandemic has emerged over the past month, state insurance departments have issued directives in reaction to the crisis, requiring such actions as a temporary moratorium on cancellations and coverage for...more
On Monday, March, 30, 2020, CMS released a blanket waiver (the “Waiver”) of the physician self-referral law under section 1135 of the Social Security Act to enable health care provider responses to the COVID-19 outbreak. ...more
On January 31, 2020, the President signed a Proclamation imposing visa and admission restrictions on Eritrea, Kyrgyzstan, Nigeria, Sudan, Tanzania and Myanmar (Burma). Restrictions for these countries are limited to immigrant...more
The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more
The Center for Biological Diversity, Defenders of Wildlife, and Animal Legal Defense Fund (collectively “CBD”) filed an October 17th Complaint for Declaratory and Injunctive Relief (“Complaint”) challenging the issuance of...more
This is the sixth issue of WilmerHale's 10-in-10 Infrastructure Series. In this series, our attorneys share insights on current and emerging issues affecting infrastructure project developers in the United States. Attorneys...more
• Four bills are currently pending in Congress to repeal or limit the reach of the Jones Act, including three that are focused upon relief efforts to assist Puerto Rico after the disastrous effects of Hurricane Maria. •...more
Action Item: On September 28, 2017, Acting Department of Homeland Security (“DHS”) Secretary Elaine Duke issued a 10-day Jones Act waiver in the interest of national defense and in response to the devastation caused by...more
In response to the Governor of Puerto Rico’s request, the Department of Homeland Security (DHS) waived the Jones Act on Thursday. The waiver covers all products shipped to Puerto Rico laded on board a vessel over the next ten...more
On September 24, 2017, President Trump issued a proclamation entitled, “Enhanced Vetting Capabilities and Processes for Detecting Attempted Entry into the United States by Terrorists or Other Public-Safety Threats” (“the...more
Acting Secretary of Homeland Security Elaine Duke on Sept. 28, 2017, approved a waiver of the Jones Act in response to the severe impact Hurricanes Irma and Maria have had on Puerto Rico. The U.S. Department of Homeland...more
The U.S. Department of Homeland Security (DHS) on Sept. 27, 2017, said that it has not formally denied a Jones Act waiver for Puerto Rico requested on Sept. 25 by Rep. Nydia Velázquez (D-N.Y.) and seven other members of the...more
This edition of the Cozen O’Connor Maritime and Infrastructure Federal Update highlights: (i) the unprecedented nature of the recent Jones Act waiver, (ii) available infrastructure funding through the TIGER program, (iii)...more
Acting Secretary of Homeland Security Elaine Duke has issued an extension of the original Sept. 8 Jones Act waiver to Sept. 22. The extended waiver, dated Sept. 11, 2017, but only recently posted by the U.S. Department of...more