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
A recent update and clarification from the Department of State (DOS) on waiver eligibility expands opportunities for visa applicants facing difficulties in obtaining visa stamps for entry to the U.S. This clarification,...more
Imagine that your company has just been sued by a competitor for patent infringement, deceptive advertising, unfair competition, or any number of other business torts. The news of the lawsuit has been reported in various...more
Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more
Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81. The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more
In Lithko Contr., LLC v. XL Ins. Am. Inc., No. 31, Sept. Term, 2023, 2024 Md. LEXIS 256, the Supreme Court of Maryland considered whether a tenant who contracted for the construction of a large warehouse facility waived its...more
Typically, in order to modify support or custody/parenting time provisions in an agreement or judgment/order, the party seeking a modification must show a substantial and continuing change of circumstances. Given the goal of...more
On August 15, 2024, the United States District Court for the Northern District of Texas vacated a Medicare regulation excluding from the Medicare DSH payment days attributable to inpatients covered by a section 1115 waiver...more
In litigation underlying Satcher v. Columbia County, 2024 WL 3802370 (Ga. Aug. 13, 2024), property owners sued the County related to damage caused by their privately-owned 48-inch pipe that had been used as part of the...more
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
In a recent decision, the North Carolina Court of Appeals held that a general contractor’s execution of partial lien waivers did not prejudice a supplier’s lien rights on the construction project. The case is Atlantech...more
On April 12, 2024, the Texas Supreme Court handed down two decisions clarifying its interpretation of governmental immunity and waiver under Section 271.152 of the Texas Local Government Code. Governmental units, including...more
On July 19, the US District Court for the Northern District of Texas denied a motion to dismiss Blue Cross Blue Shield of Texas (BCBSTX), which claimed sovereign immunity in a suit brought by a group of providers. In so...more
California courts, like most federal courts, have historically held that a party does not waive its contractual right to compel arbitration unless the party opposing arbitration has been prejudiced by the moving party’s delay...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
In this issue we discuss the new Labour government’s proposals to strengthen protections for employees; an Employment Appeal Tribunal decision that affirmed that an employee’s waiver of future claims that were unknown at the...more
In June 2024, the Biden Administration announced several immigration actions using the authority of the executive branch. Within a political landscape of stalemate on virtually all things immigration, it has not been unusual...more
In the backdrop of uncertainties surrounding Deferred Action for Childhood Arrival (DACA) and the ongoing congressional deadlock, hundreds of thousands of DACA recipients, often referred to as ‘Dreamers’, continue to make...more
Wise or not, parties have a right to waive discovery from the other party and settle their matter. Sometimes, both parties have access to and/or knowledge of all of the finances. Sometimes, the rely on the parties sworn Case...more
A Céspedes for the Rest of Us! Ex-New York Met Has Himself a Day, Winning a Critical Preliminary Injunction, as Chandler Bats Founder Finds Himself in a Pickle - The companies of ex-MLB player Yoenis Céspedes—La Potencia,...more
In Ohio Sec. Ins. Co v. Brakefire, Inc., CA. No. 5:24-cv-267, 2024 U.S. Dist. LEXIS 97606 (Brakefire), the United States District Court for the Northern District of Ohio considered whether a subrogating plaintiff’s negligence...more
California’s ambitious zero-emission, heavy-duty truck regulations face new legal challenges. Our Environment, Land Use & Natural Resources Group outlines the status of California’s Advanced Clean Fleet (ACF) Regulation,...more
On June 18, 2024, the Media Bureau of the Federal Communications Commission (FCC or Commission) released a Memorandum Opinion and Order (Order) granting a rare waiver of its Top-Four Prohibition to allow Marquee Broadcasting...more
A recent Commonwealth Court decision provides important lessons about the challenges developers face when seeking a waiver from provisions of a municipality’s subdivision and land development ordinance (SALDO). In M&D...more
To avoid delays, U.S. Customs and Border Protection (CBP) wants to remind everyone who will be traveling this summer about its technologies, including lots of mobile apps, that will help streamline the reentry process for...more
While it is not novel to see administrator registration requirements for vehicle service contracts or other vehicle protection products, Oklahoma recently enacted SB 541 which now requires the registration of debt waiver...more