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 September 27, 2022 and October 3, 2022, CMS announced additional resources and flexibilities available for Florida and South Carolina in response to the aftermath of Hurricane Ian. Following the President’s...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
A few weeks back, as remote working and social distancing were becoming the order of the day (and interesting phrase, given what quickly became the norm in many US states and cities, as executive orders abounded), my son...more
In times of emergency, the Secretary of Health and Human Services (the "Secretary") has authority to issue temporary waivers or modifications of certain Medicare, Medicaid, CHIP, and HIPAA requirements. The Centers for...more
On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the...more
On March 30, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a compilation of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (each, a “Blanket Waiver”). Section 1135 of the...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
On March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services...more
Amid the economic shocks caused by the Coronavirus (COVID-19) crisis, many industries are facing reduced demand for their products and services. Other industries—notably healthcare and food—are adjusting rapidly to expanding...more
On March 25, 2020, the Senate voted 96-0 to approve the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The House is expected to vote on this bill on Friday, March 27....more
Responding to the Coronavirus public health emergency, the Secretary of Health and Human Services (HHS) has waived certain requirements of the Medicare, Medicaid and Children’s Health Insurance Program (CHIP), including...more
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more
The nation’s healthcare system is preparing to reach record capacity in the coming weeks. Much focus has been on the limited capacities of the nation’s acute care hospitals....more
The federal government granted North Carolina permission on March 23 for health care providers across the state to temporarily avoid compliance with certain federal Medicaid requirements. The idea is to reduce bureaucracy...more
In response to the global Coronavirus (COVID-19) pandemic, US state and federal government agencies have worked to promote utilization of telehealth. Prior to and following President Trump’s declaration of a national...more
On March 18, 2020, Governor Jim Justice suspended the rule prohibiting bars and restaurants from providing beer and wine for off-premises consumption. Restaurants and bars with Class A licenses are now permitted to sell...more
In response to disruptions to Virginia taxpayers caused by the COVID-19 crisis, the Virginia Department of Taxation (the “Department”) has extended the deadline for Virginia taxpayers to pay their income taxes. This relief...more
President Donald Trump declared the coronavirus pandemic a National Emergency on March 13, 2020. This declaration granted the Department of Health and Human Services (HHS) Secretary Alex Azar authority to relax certain...more
As the number of confirmed cases of the novel coronavirus disease (COVID-19) continues to tick upward in the United States, administrative agencies are taking steps on a national scale to ensure that adequate healthcare items...more
On March 17, 2020, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a Policy Statement addressing the ability of physicians and other practitioners to reduce or waive patient...more
COVID-19 Grips Federal Policymakers. Like the rest of the country, lawmakers and regulators spent much of this week grappling with the effects of the COVID-19 virus. Below is a quick rundown of the various responses from...more
Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak. Several of those announcements...more
Following President Trump’s proclamation on March 13, 2020, that the COVID-19 pandemic in the United States constitutes a national emergency, the Department of Health and Human Services (HHS) issued a Waiver or Modification...more
Effective March 15, 2020, certain hospitals that fail to comply with specific HIPAA Privacy Rule requirements will not be subject to HIPAA sanctions and penalties, according to a “COVID-19 & HIPAA Bulletin” issued by U.S....more
On March 13, 2020, President Trump declared a national state of emergency as a result of the coronavirus (COVID-19) outbreak. Regardless of the intensity of the emergency from COVID-19 in a particular area, the President’s...more