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
On July 25, 2025, the U.S. Department of State announced a new policy that will significantly limit the eligibility of visa applicants to obtain visas without consular interviews. The new policy will go into effect on...more
Foley & Lardner provided an update for multinational companies to mitigate risks posed by the Trump administration’s focus on drug cartels and transnational criminal organizations (TCOs). Visit Foley & Lardner’s Trump...more
President Trump took steps to dismantle California’s vehicle emissions standards on June 12, 2025, by signing three Congressional Review Act (“CRA”) resolutions revoking California’s waiver under the Clean Air Act. The waiver...more
The Congressional Review Act (“CRA”), enacted in 1996, allows Congress to disapprove federal regulations promulgated by government agencies within 60 legislative working days after the rule is submitted to Congress. In order...more
In the weeks since Holland & Knight previously reported on challenges to California's Clean Air Act (CAA) preemption waivers on April 30, 2025, Congress has taken decisive action. Following the U.S. House of Representatives'...more
The short-term spending bill President Donald Trump signed into law last month included the extension of several telehealth waivers by entering a new termination date of Sept. 30 into the existing law. These waivers, called...more
In 2023, the Federal Motor Carrier Safety Administration (“FMCSA”) under the Biden administration started accepting public comments about the many petitions for waiver that key stakeholders, including the California Attorney...more
The U.S. Department of State has announced updated guidance restricting eligibility for nonimmigrant visa interview waivers at U.S. Consulates. Under the revised guidance, nonimmigrant visa applicants may be eligible for an...more
Under Clean Air Act (CAA) Section 209(a) (42 U.S.C. § 7543), states are preempted from adopting or enforcing emissions standards for new motor vehicles or new motor vehicle engines. However, because California had adopted its...more
In November 2019, President-elect Donald Trump’s first administration’s withdrawal of California’s emissions waiver went into effect. ...more
On the day of his inauguration, President Joe Biden issued a historic number of executive orders, several of which focused on overturning actions taken by the Trump Administration’s Environmental Protection Agency (EPA). We...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On January 22, 2022, Georgia and the Georgia Department of Community Health filed suit against the Centers for Medicare & Medicaid Services (CMS) seeking to prevent the rescission of the central aspects of Georgia’s 1115...more
Last week, the National Highway Traffic Safety Administration proposed to withdraw Part I of the Trump Administration’s SAFE Rule, in which EPA had concluded that California’s regulation of motor vehicle GHG emissions was...more
CMS approved Georgia’s Section 1115 demonstration project to partially expand Medicaid coverage for adults not otherwise eligible for Medicaid coverage with incomes up to 95 percent of the Federal Poverty Line (FPL)—short of...more
On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was...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
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
In response to President Trump's declaration of a national emergency concerning COVID-19, the U.S. Department of Health and Human Services (HHS) has issued a limited waiver of sanctions and penalties against covered hospitals...more
After first invoking the Defense Production Act (DPA) on March 18, 2020, President Donald Trump has taken several actions to formally deploy the authorities we discussed in our March 20, 2020, client alert, “President Trump...more
In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to...more
The global pandemic caused by the novel corona virus has certainly shaken up our normal way of life and will do so for the foreseeable future. Times like this reinforce the importance of public health insurance programs like...more
On March 13, 2020, President Donald Trump declared a national emergency under the National Emergencies Act and made an emergency determination under the Stafford Act. This announcement follows the January 31, 2020,...more
With the emergency declaration under the National Emergencies Act related to the coronavirus (COVID-19) on March 13, 2020, President Trump paved the way for CMS to temporarily waive certain Medicare, Medicaid, and Children's...more