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 Short - The Situation: In 2020, a cruise ship in Australian waters, the Ruby Princess, experienced a COVID‑19 outbreak that resulted in an Australian class action. Part of the class were passengers subject to...more
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
This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20, which authorized the...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 May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s...more
- Federal emergency authorities targeting COVID-19 provide important protections to businesses for certain actions in connection with the national response to the public health crisis. - The protections include immunity...more
As a follow up to our legal alert posted on April 7, 2020, the Federal Communications Commission ("FCC") announced that it is accepting applications for its $200 million COVID-19 Telehealth Program as of April 13, 2020. As a...more
Update 04.10.2020: The FCC has launched an online portal explaining the application process for grants from the $200 million in funding to support telehealth services described in this client update. The FCC will begin...more
The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more
Recognizing the need to make health services available during the current state of emergency, California Governor Gavin Newsom issued Executive Order N-43-20 (the “Order”) on April 3, 2020. The Order temporarily expands the...more
The Program will guide disbursement of $200 million to health care providers for connected care services. Health care providers interested in receiving funds must complete a three-step process that requires advance planning....more
As we previously reported, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) (“CARES Act”) on March 27, 2020. We recently provided guidance on how the CARES Act...more
As the COVID-19 pandemic has emerged over the past month, state insurance departments have issued directives in reaction to the crisis, requiring such actions as a temporary moratorium on cancellations and coverage for...more
The Centers for Medicare & Medicaid Services, (“CMS”) announced this week that it will pay claims for designated health services related to COVID-19 that would ordinarily violate the Stark Law. On March 30, 2020, the...more
The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more
On Monday, the Chairman of the Federal Communications Commission (FCC), Ajit Pai, circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a...more
On March 30, 2020, CMS issued updates to its prior QSO memorandum, expanding its infection control and prevention guidance to include hospitals, critical access hospitals and psychiatric hospitals. The updated QSO memorandum...more
On Monday, March, 30, 2020, CMS released a blanket waiver (the “Waiver”) of the physician self-referral law under section 1135 of the Social Security Act to enable health care provider responses to the COVID-19 outbreak. ...more
On Saturday, March 28th, the Centers for Medicare & Medicaid Services (“CMS”) announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers to help...more
As the 2019 novel coronavirus (COVID-19) pandemic continues to strain the healthcare industry, the Centers for Medicare & Medicaid Services (CMS) eased healthcare provider enrollment rules. CMS has significantly streamlined...more
Since the outbreak of COVID-19, the Department of Health and Human Services Office for Civil Rights (OCR) has issued various guidance documents on compliance with the Health Insurance Portability and Accountability Act of...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
In the midst of the Coronavirus (COVID-19) pandemic, healthcare providers and suppliers will need to make decisions on how to ensure compliance with existing federal fraud and abuse laws while taking swift action to avoid...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
Acknowledging the “additional challenges” on health care providers following the outbreak of COVID-19, the Department of Health and Human Services (HHS) recently issued several waivers for covered entities to address the need...more