Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021. Catch up on what you may have missed below.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
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.
Please join us for a webinar on Thursday, January 14 at 3:00 pm ET to discuss the refreshed Paycheck Protection Program (PPP) and the new PPP Second Draw program. This program will highlight key provisions and guidance for businesses seeking to participate in the revived PPP under the Consolidated Appropriations Act, which may be of interest to readers of Health Law Scan.
Our employee benefits team recently published a LawFlash discussing the Consolidated Appropriations Act, 2021, which contains provisions impacting employer sponsored group health plans, including to protect group health plan participants from surprise medical bills, ensure health plan price transparency, and offer relief related to health and dependent care flexible spending accounts.
Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the FDA made to prioritize its review of rapid and at-home test solutions.
On December 8, 2020, Judge Gerald Pappert in the US District Court for the Eastern District of Pennsylvania denied a request from the Federal Trade Commission (FTC) and Pennsylvania attorney general (AG) to preliminarily enjoin a proposed merger between Thomas Jefferson University (TJU) and Albert Einstein Healthcare Network (Einstein). The case was widely watched as the FTC sought to show that the combination of these two urban hospital systems would harm consumers.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. Companies and healthcare providers that develop, manufacture, distribute, or use COVID-19 countermeasures, such as diagnostic tests, ventilators, and personal protective equipment, have had the benefit of potential broad liability protection under the federal Public Readiness and Emergency Preparedness (PREP) Act. Early on in the pandemic, the US Department of Health and Human Services (HHS) issued a declaration to provide liability protection for COVID-19 countermeasures.
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.