Members of our healthcare team recently published a LawFlash highlighting the American Rescue Plan Act of 2021 (ARPA). ARPA provides $1.9 trillion in relief funding to address the COVID-19 pandemic, support the US economy, and provide relief for impacted Americans, and includes provisions specifically affecting healthcare providers remaining on the frontlines.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Members of our financial services and banking teams recently published a LawFlash discussing the Biden administration’s recent changes to the Paycheck Protection Program aimed at providing greater access to funds for small businesses in need and in underserved communities. The LawFlash highlights key provisions and guidance for businesses seeking to participate in the program before it officially expires on March 31, 2021 (pending any additional legislation from Congress).
Members of our labor and employment team published a LawFlash discussing the Biden administration’s Centers for Disease Control and Prevention’s (CDC’s) updated COVID-19 guidance. The LawFlash dives into the significant new guidance, including testing, quarantining, and mask-wearing. This may be of particular interest to Health Law Scan readers who are considering return to work issues.
On the heels of the US Department of Justice’s (DOJ’s) Criminal Division Fraud Section releasing its annual Year in Review, our white collar team published a LawFlash discussing the report, which highlights DOJ’s sustained aggressive enforcement efforts despite the COVID-19 pandemic.
The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE). As part of this increased scrutiny, OIG has made a number of statements critical of the telehealth industry and the perceived lack of controls over virtual services. Telehealth stakeholders, meanwhile, have pushed back that OIG’s concerns about so-called “telefraud” are overly broad. In light of these concerns, OIG issued a statement on February 26, 2021 clarifying its perspective with respect to this new technology. OIG’s statement should be welcome relief for telehealth providers.
Our labor and employment team recently published a LawFlash covering the Occupational Safety and Health Administration’s new employer guidance on workplace safety during the COVID-19 pandemic. This new guidance, released on January 29, recommends that employers implement a COVID-19 prevention program, explores key measures for limiting the spread of COVID-19, and highlights other new and noteworthy recommendations.
Members of our vaccine taskforce recently published an important Insight outlining a selection of key legal considerations and updates as the COVID-19 vaccine rollout continues to take shape, including the status of the US Food and Drug Administration’s vaccine products, distribution, key legal issues at the state level, employer mandates and employee incentives, and important liability concerns.
The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act). HHS has been working to provide updated reporting requirements that comply with this recently passed legislation.
Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.
Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.