HHS recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI), in an apparent effort to combat prescription drug shortages and price spikes. This announcement essentially walks back FDA’s enforcement approach regarding “marketed unapproved drugs,” allowing them to continue to be sold consistent with the 2006 FDA policy. Although the incoming Biden administration may ultimately decide to reinstitute the UDI program, unapproved drugs may be excluded from coverage by Medicare and Medicaid and by private health plans that follow federal plan coverage standards.
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. The rule changes will transform fraud and abuse compliance and accelerate what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”
The upcoming change in the US presidential administration is expected to significantly alter the landscape of immigration adjudication and enforcement in the United States. Our immigration team will present a one-hour webinar examining some of the changes that President-elect Joseph Biden’s administration could make to US business immigration policy, as well as recent USCIS and DOL regulatory changes and immigration in post-Brexit Europe.
We will discuss how these changes may affect multinational employers and US healthcare organizations with foreign-born healthcare workers residing in the United States.
Thursday, November 19, 2020
12:00–1:00 pm ET
Join Morgan Lewis for the first session of a new webinar series, the Morgan Lewis Global Sponsor Forum. We will discuss potential implications of the 2020 US election results across various private fund targeted industries, including healthcare and life sciences, energy and infrastructure, credit, technology, and education. This new webinar series will examine key trends, terms, and issues across these various industry sectors.
The Morgan Lewis Global Sponsor Forum webinar series is led by a diverse team of investment fund lawyers and will feature key industry participants. We hope to see you at the first session on Wednesday, November 18, 2020 at 12:00 pm ET/9:00 am PT.
Healthcare systems have been on the front lines of the coronavirus (COVID-19) pandemic and may have several questions about how to manage workforce challenges as we look toward the upcoming months.
Join us for a webinar featuring lawyers from our labor and employment, employee benefits, and healthcare regulatory practices to discuss practical approaches to workforce challenges.
We invite you to join Morgan Lewis and the Wharton Center for Human Resources for a post-election series of webinars featuring insights from current and former officials of the US federal agencies that regulate the workplace. Featured speakers from the US Department of Labor (DOL), the Equal Employment Opportunity Commission (EEOC), and the National Labor Relations Board (NLRB) will provide perspectives from each agency on the current challenges facing employers. A final session will focus on the workplace policy outlook for 2021 and will discuss implications of the November 2020 election.
- The EEOC: What’s on the Horizon?
Tuesday, November 10, 2020 | 1:00–2:00 pm ET
- The NLRB at Work: Regulating Labor-Management Relations, Unions, Employers, and More
Tuesday, November 17, 2020 | 1:00–2:00 pm ET
- The DOL and Workplace Compliance Standards: What Does the Future Hold?
Tuesday, December 1, 2020 | 1:00–2:00 pm ET
- Workplace Policy in 2021: The Big Picture
Tuesday, December 8, 2020 | 1:00–2:30 pm ET
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States. EPA maintains a list of pesticide products that should kill the SARS-CoV-2 virus, called List N. EPA recently released new interim guidance allowing it to expedite review of some applications for new and amended registrations for products intended to kill SARS-CoV-2.
EPA now plans to expedite its review of the addition of residual efficacy claims for current or new registrations on List N, products that would qualify for List N, or products that can be used as a residual supplement for disinfecting products already on List N. Residual efficacy claims are essentially claims that a product has antimicrobial effects for extended periods of time—up to days, weeks, or even months.
Healthcare entities should be sure to use only List N products for any surfaces that need to be sanitized for SARS-CoV-2 exposure, and should be on the lookout in the future for any products that may be added to the list with residual sanitizing claims. Providers should also note that some surface sanitizing products may be subject to both EPA and FDA jurisdiction, and may potentially require FDA review. However, this interim guidance does not apply to products that are subject to FDA’s exclusive jurisdiction, like hand sanitizers.
Telehealth is a highly regulated field and legal issues can vary across payers, across states, and even across countries. Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In China, the Chinese government has been actively promoting internet-based medicine, even before the COVID-19 pandemic accelerated the need for telehealth services.
In July 2018, the National Health Committee and the State Administration of Traditional Chinese Medicine jointly issued the three fundamental rules that formed the basic legal framework of China’s internet-based medicine. According to the rules, internet-based medicine in mainland China is classified into three categories: internet-based diagnosis, internet hospitals, and telemedicine services. The Chinese government continues to adjust regulations on internet-based medicine as there are still many issues that have not yet been addressed under the existing legal framework.
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.” The full list of providers eligible for PRF Phase 3 Payment application is listed on the HHS website, and HHS confirmed that these providers may apply “regardless of whether they accept Medicaid or Medicare.” (Read the announcement for more information.)
The coronavirus (COVID-19) pandemic has brought numerous changes and challenges to the healthcare industry. These disruptions have encouraged an increased need for innovation and the development of groundbreaking technology to meet the healthcare industry’s vulnerabilities. Do you have projects or solutions you would like to turn into a viable business for the long term?
Join us for a new and exciting series of webinars aimed at helping entrepreneurs kick off and grow their businesses.
These timely and engaging presentations will provide practical tips and address opportune topics that will be invaluable to entrepreneurs. We will structure the presentations in a discussion format, leaving plenty of time for questions and answers.