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 30, 2023, President Biden announced that both the COVID-19 national emergency and the public health emergency (PHE) will end May 11, 2023. This announcement has left many healthcare providers considering how the...more
The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020...more
This content was last updated as of Thursday, April 24 at 12:00 p.m. CST- The Centers for Medicare & Medicaid Services (CMS) continues its issuance of Section 1135 waivers, waiving or modifying certain Medicare, Medicaid,...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a 29-page summary of the numerous blanket waivers issued to provide flexibilities to health care providers combating the COVID-19 pandemic....more
The Centers for Medicare & Medicaid Services (CMS) continues its issuance of Section 1135 waivers, waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a series of temporary regulatory waivers in order to aid the response to the 2019 Novel Coronavirus (COVID-19), as follows. Increasing Hospital...more
On March 30, 2020, CMS announced its “Hospitals Without Walls” initiative, which, among other things, invokes the HHS EMTALA waiver effective immediately. Specifically, the CMS Hospitals Without Walls Initiative waives...more
On March 13, 2020, when President Trump declared a national emergency under the Stafford Act, the Secretary of Health and Human Services utilized his authority to take particular actions, such as temporarily waiving or...more
The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to...more
On March 30, 2020, CMS issued numerous additional blanket waivers to give providers greater flexibility in responding to COVID-19. (See https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf)....more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued new blanket 1135 waivers, making what CMS describes as “sweeping regulatory changes” to the health care system....more
When the White House declared a national emergency in mid-March, it allowed the authorization of waivers of certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements, often referred to as Section...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
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
On March 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) Quality, Safety and Oversight Group (“QSO”) issued a memorandum, QSO-20-15, providing guidance to health care providers related to the Emergency Medical...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 a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...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
On March 13, 2020, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers of certain requirements following the President’s National Emergency Declaration. Current waivers are briefly summarized below. ...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
On March 13, 2020, the Secretary of the U.S. Department of Health And Human Services (HHS) issued a series of waivers pursuant to Section 1135 of the Social Security Act, following President Trump’s declaration that the...more
On March 13, 2020, following President Trump’s declaration of a national emergency due to the COVID-19 (coronavirus) pandemic, the Secretary of Health and Human Services (HHS) issued, among others, the following Emergency...more
In response to the spread of COVID-19 infections and questions from the provider community, the Centers for Medicare and Medicaid Services (CMS) Quality, Safety and Oversight Group (QSO) issued a series of three memoranda...more
Hospitals operating in regions affected by the recent hurricanes and other natural disasters may be able to obtain temporary regulatory relief. During times of disasters and emergencies, CMS can provide some flexibility...more