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 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
We are still reviewing the just-released draft waiver from Oklahoma, but wanted to share with our readers in the meantime. As we’ve discussed... we expected Oklahoma to be the first-mover after release of the Trump...more
UPDATED: It’s out! The much anticipated guidance, entitled the “Healthy Adult Opportunity” (HAO), from CMS introducing ways to revamp Medicaid financing has been out for nearly a week and we have had some time to review the...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
Yesterday President Trump announced on Twitter that the U.S. was revoking California’s waiver under the Clean Air Act (CAA) which allowed it to impose stricter tailpipe emission standards than the federal ones. California’s...more
According to its text, the Trump Administration’s travel ban is not absolute. It currently prohibits entry into the United States by all immigrants and certain nonimmigrants from Iran, Libya, North Korea, Somalia, Syria, and...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
Companies in the banking/financial, energy, logistics, and shipping sectors should assess their operations to mitigate sanctions compliance risks. On Monday, April 22, 2019, the Trump Administration announced that, in the...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 January 25, 2019, President Donald Trump signed into law a continuing resolution that immediately reopened the federal government through February 15, 2019. The three-week continuing resolution is a welcome development,...more
U.S. to Give Eight Nations Oil Waivers Under Iran Sanctions, Official Says - "The U.S. has agreed to let eight countries - including Japan, India and South Korea - keep buying Iranian oil after it reimposes sanctions on the...more
On May 8, 2018, the United States withdrew from the Joint Comprehensive Plan of Action and reimposed all pre-JCPOA sanctions against Iran... After a prescribed wind-down period, all U.S. sanctions on Iran are now in force....more
Following the U.S. decision to withdraw from the Joint Comprehensive Plan of Action (JCPOA) and reimpose sanctions on Iran, the EU has confirmed its full commitment to keep the agreement alive for the remaining parties, as...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