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.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Our finance, corporate and business transactions, litigation, and tax teams recently published a LawFlash discussing the new coronavirus (COVID-19) relief stimulus package that is part of the Consolidated Appropriations Act, 2021 (CAA), highlighting key provisions and guidance for small businesses seeking to participate in the revived Paycheck Protection Program (PPP).
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.
Our tax team published a LawFlash on the recently released Internal Revenue Service Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program (PPP).
Our immigration team recently posted a LawFlash to discuss a recent decision by the US District Court for the Northern District of California that set aside two Interim Final Rules (IFRs) that sought to restrict severely eligibility for the H-1B Specialty Occupation nonimmigrant category.
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.
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.”
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.