Legal Insights and Perspectives for the Healthcare Industry
Another year has come to pass, and it seems the federal Public Health Emergency (PHE) will remain in place for at least the next five months. Why? As the US Department of Health and Human Services (HHS) has continuously pledged throughout the COVID-19 pandemic, the federal government intends to give states and healthcare providers at least a 60-day notice before terminating the PHE, which has granted significant flexibilities for furnishing healthcare services covered by Medicare, including in the context of telehealth. That 60-day notice period for the current PHE expiration date came and went on November 12 with no word from Secretary Xavier Becerra that the federal government would seek to wind down PHE flexibilities at the start of 2023. As a result, the PHE in all likelihood will be extended for an additional 90 days in early January 2023, for a revised expiration date of April 11, 2023.
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.
Members of our healthcare and life sciences teams recently published an analysis of key insurance, liability, and enforcement considerations for organizations providing vaccine access. Highlights include the state and federal laws providing protection to organizations during an outbreak of an infectious disease, what is important for private employers contemplating the administration of closed point-of-delivery vaccination programs to know, and current enforcement trends.
We invite Health Law Scan readers to join Morgan Lewis for the 11th Technology May-rathon, our annual series of tailored webinars focused on current technology issues, trends, and developments that are of key importance to our friends and clients.
Members of our digital health and technology, outsourcing, and commercial transactions teams recently published a resource providing analysis of key considerations for tech service providers and life sciences companies collaborating in the digital health space, whether in regards to the development of artificial intelligence or other software, the provision of data hosting and analysis services, or a more complex collaboration.
We invite Health Law Scan readers to join Morgan Lewis for an upcoming webinar series, Privatization of the Vaccine Rollout, which will explore the legal and regulatory issues for businesses that have become increasingly central to rolling out vaccines in the United States and around the globe.
Please join members of our immigration team for a webinar on Wednesday, February 17 at 1:00 pm ET, examining the impact of the Biden administration on US business immigration policy through legislative proposals, redirected agency priorities, and regulatory shifts, and what these initiatives may foretell for US employers that seek to recruit and hire talented foreign nationals.
Healthcare is a highly regulated space, and regulators are continuing to issue new policies and regulations to address the critical needs for goods and services to combat the coronavirus (COVID-19), while also protecting the public health. Companies beyond just healthcare and life sciences should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability requests.
Healthcare partners Al Shay and Howard Young and associate Jake Harper recently contributed to the Health Care Compliance Legal Issues Manual, a publication by the American Health Lawyers Association (AHLA).
The Office of Management and Budget’s (OMB’s) policy statement emphasizes the role of the Congressional Review Act in the rulemaking process and incorporates rulemaking actions that were not consistently subject to prepublication review under standing executive orders. Questions remain regarding the prospects for regulatory gridlock and burdensome delays.