COVID-19 Viewpoints

Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.

On March 12, 2020, the IRS issued notice 2020-15, providing that a health plan will not fail to be a High Deductible Health Plan (HDHP) merely because it provides testing for and treatment of COVID-19 without a deductible or subject to a reduced deductible. Therefore, an individual who participates in such a plan may continue to participate in a Health Savings Account (HSA).

This alert reviews USCIS’s requirements for Form I-9 — required for all new hires in the United States — and the special challenges that completing the form poses in light of the spread of the coronavirus, COVID-19.

With the outbreak of coronavirus disease 2019 (“COVID-19”), the disease caused by the novel coronavirus (“SARS-CoV-2”), companies across various industries are taking precautions, some of which already have, and inevitably will result in nonperformance of their contracts.

COVID-19 is not the only virus associated with the global outbreak. As predictably as night follows day, cybercriminals have been using the epidemic as a means to spread their malicious payloads. Companies should include information about cyber hygiene along with the CDC recommendations of hand washing, particularly given the potential for increased remote access to corporate IT systems.

Read about the SEC’s March 4 order granting issuers and other persons relief from some securities law requirements in the event of disruptions due to the coronavirus.

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.

Read about updated CDC and DOS travel guidance for Iran, Italy, China, South Korea, Japan, and Hong Kong and President Trump's entry ban for foreign nationals who have been in Iran within 14 days.

In light of the Coronavirus’s continued impact in the workplace, this post reviews the CDC’s newly issued guidelines for businesses, and dives deeper into how employers can lawfully navigate the Americans with Disabilities Act (ADA), sick time laws, and other leave laws, while maintaining the safety of their workforce.

This alert covers recent State Department and US Consulate notices regarding restrictions on entry into the US related to the spread of the coronavirus.

As the coronavirus remains to be an active outbreak with cases increasing within the United States, this is a good time to review how HIPAA applies in a public health emergency, including its restrictions and flexibility in these types of situations. Accordingly, last week, the Office for Civil Rights (OCR) released a helpful bulletin on how the HIPAA Privacy Rule comes into play with the coronavirus outbreak and other public health emergencies.

Read about the administration's temporary suspension, effective Feb. 2, of the entry of non-US citizens or permanent residents who have been in China, excluding Hong Kong and Macau, during the prior 14 days.

This immigration alert provides details on a proclamation from President Trump extending the travel ban as well as an announcement that the United States is temporarily suspending the entry of foreign nationals who have been in China.

The recent outbreak of the Coronavirus in Wuhan, China, which has spread to the United States with new cases being reported every day, has the global community on high alert. While employers would be wise to leave the containment and treatment of the virus to medical experts, disease outbreaks present a unique set of employment law issues for many businesses, especially for those that require international travel as an essential job function for their employees.  This post addresses some of the employment issues raised by the Coronavirus outbreak.  (Note: we recognize events on the ground are fluid, and therefore will update this post as necessary.)