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
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more
On April 12, 2022, Department of Health and Human Services (HHS) Secretary Xavier Becerra again renewed the declaration of a Public Health Emergency (PHE) under the Public Health Service Act, averting an April 16, 2022...more
As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. The Public Health...more
On March 30, 2020, the Secretary of the U.S. Department of Health and Human Services issued a "blanket waiver" impacting the physician self-referral law known as the Stark Law. The blanket waiver—which is retroactively...more
As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more
The COVID-19 emergency presents an unprecedented need to communicate quickly and effectively from a distance. Telehealth and telecommunications applications more broadly are poised to address the potentially crushing demand...more
On March 6, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act (the Act). The Act includes a provision allowing the Secretary of the Department of Health and Human...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
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more
As Hurricane Harvey continues to have a devastating impact throughout Southeast Texas, Louisiana and the Southeast, our thoughts are with the hundreds of thousands struggling through this difficult time....more
Arkansas - Governor Proposes Changes to Medicaid Expansion Waiver as House Passes Bill to Cap Expansion Enrollment - Governor Asa Hutchinson (R) released a proposal to amend the State's Medicaid expansion waiver by...more
New guidance from Centers for Medicare & Medicaid Services (CMS) places the spotlight on the ability of states to seek approval of “State Innovation Waivers” to test new approaches for delivering health insurance reform....more