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
At the onset of the COVID-19 PHE, CMS was permitted to issue several temporary emergency statutory and regulatory waivers to help providers appropriately respond to the pandemic. On May 1, 2023, the Secretary released a memo...more
With the COVID-19 Public Health Emergency (PHE) ending on May 11th, providers and practitioners must carefully consider the dates when various telehealth waivers and flexibilities end. This requires understanding the...more
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
Companies who feel the Public Health Emergency (PHE) waivers and exceptions have rendered telemedicine “immune” from compliance oversight might be surprised to learn what federal regulators have in the works. The Office of...more
In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a...more
In a rapid and remarkable response to COVID-19, The Centers for Medicare & Medicaid Services (CMS) has altered a wide range of coverage and payment rules applicable to hospitals, practitioners and suppliers. In an interim...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced additional measures to provide home health agencies (“HHA”) greater flexibility when treating patients during the National Emergency....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
Editor's Note: Faced with mounting evidence about the impact of social factors—such as income, access to food and housing, and employment status—on health outcomes, Medicaid agencies are looking for ways to integrate social...more
The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services just issued a final rule setting forth waivers of specified fraud and abuse laws...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more