Assistance related to Coronavirus vaccines
- Advising employers on potential COVID-19 vaccine scenarios, including whether as an employer work safety program or administered by a HIPAA covered health plan.
- Advising clients, including health plans, on federal and state protocols and payment policies regarding administration of the two-dose COVID-19 vaccines.
- Advising employers on potential issues involved in considering whether a COVID-19 vaccine will be offered as a mandatory or voluntary measure.
- Assisting with the submission of an Investigational New Drug (“IND”) application on behalf of the developer of a SARS-CoV-2 vaccine. Alston & Bird’s work included protocol review, as well as advice regarding the delivery system for the vaccine, and assistance addressing FDA questions regarding the application.
- Advised on IP issues for treatments and/or vaccines relating to COVID-19.
Assistance with SBA loans, CARES Act relief, and state and local relief
- Assisting numerous companies and nonprofits, in a wide range of industries from hospitality to colleges and universities to defense contractors, in determining eligibility for the Paycheck Protection Program and guiding these clients through the application, documentation, and loan forgiveness associated with the PPP.
- Advising multiple banks, including a top 15 bank, on various regulatory aspects associated with lending under the Paycheck Protection Program, including loans to related interests and due diligence on new bank customers.
- Advising private equity firms and their portfolio companies on eligibility and other programmatic requirements and restrictions related to CARES Act Paycheck Protection Program funding.
- Assisting various health care providers, including senior living facilities, behavioral health service providers, and eye care providers, in identifying strategies to secure CARES Act funding, including eligibility, recordkeeping, and reporting requirements.
- Advising clients on compliance with reporting and attestation requirements for the federal Provider Relief Fund.
Assistance with keeping essential businesses open; reopening businesses as closure orders are lifted
- Providing advice and counsel to public and private companies in the development of return-to-work plans, including compliance with CDC and OSHA coronavirus guidelines and varying mandates issued by state and local governments.
- Advising clients on protocols for employee coronavirus testing, risks and obligations for employers and laboratories, and policy issues affecting testing.
- Advising private employers on developing return-to-work site assessments, safety plans, and employee acknowledgements (including consideration of privacy implications under the California Consumer Privacy Act (CCPA) of temperature check programs or other health check attestations); analyzing California’s state and local return-to-work orders to provide advice and counsel on whether employees may properly be returned to work.
- Advising private employers on return-to-work issues involving vulnerable employees, including ADA and reasonable accommodation issues.
- Advising clients on the implications of state shelter-in-place, stay-at-home, or essential-business executive orders, with specific reference to whether they or their employees qualify as “essential” or as part of the “critical infrastructure” as defined by the Department of Homeland Security.
Assistance in response to the COVID-19 pandemic
Health care and FDA
- Working with clinical laboratories as they develop coronavirus testing models and navigate through CDC and FDA approval processes, as well as coding and payment issues that arise during product development.
- Advising on the coronavirus in the workplace and related privacy and HIPAA strategies.
- Advocacy with the Executive Branch on COVID-19-related guidance and implementation.
- Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays because of the coronavirus pandemic.
- Advising commercial manufacturers seeking to develop diagnostic test kits and personal protective equipment (PPE) for health care workers.
- Assisting FDA-regulated entities on emergency use authorizations (EUAs) for coronavirus test kits, hand sanitizers, and surgical masks.
- Assisting companies with personal data and health information in rolling out remote work policies and procedures during the coronavirus pandemic.
- Advising public hospitals and academic medical centers on establishing testing sites and coordinating additional hospital bed capacity for an influx of COVID-19 cases.
- Assisting health care providers and companies with advocacy for coronavirus-related legislative priorities and regulatory implementation.
- Assisting clients with preparing and submitting requests for Section 1135 waivers.
- Providing health system clients with advice on the application and implementation of Physician Self-Referral Law (Stark Law) blanket waivers.
- Advising lodging, hospitality, and timeshare industry clients on various business and legal matters related to the coronavirus pandemic.
- Responding to and managing communications related to employees and customers who are diagnosed with COVID-19 or display flu-like symptoms.
- Advising clients on questions related to insurance coverage during the coronavirus pandemic.
- Advising clients on the operational and financial ramifications of the coronavirus pandemic, including the availability and benefits of a potential bankruptcy filing and the ability to maximize and obtain recoveries for the benefit of creditors.
- Advising medical waste companies and residential waste companies on lifting weight and distance restrictions during the coronavirus pandemic.
- Advising companies on compliance with the EPA’s Emerging Viral Pathogen Guidance for Antimicrobial Pesticides.
- Advising hospitals and other health care providers on medical and hazardous waste characterization, management, transportation, and disposal; the EPA’s new Management Standards for Hazardous Waste Pharmaceuticals; Safe and Secure Drug Disposal Act compliance; and federal and state licensure matters and any special requirements that may arise due to the coronavirus.
- Advising on the SEC’s recent request that U.S.-listed companies with operations in China disclose any coronavirus threats or risks in their financial reporting; assessing coronavirus risks and navigating disclosures pertaining to the coronavirus in financial reporting.
- Advising public companies and their boards of directors on strategic decisions, risk oversight, governance, and SEC disclosure related to COVID-19.
- Advising clients on the impact of the coronavirus pandemic on financing and cross-border acquisitions, joint ventures, supply arrangements, and strategic partnerships.
- Assisting broker-dealers and other financial services companies on governmental restrictions, industry guidance, and marketplace regulations during the coronavirus pandemic, including business continuity planning, regulatory relief, and examination and enforcement inquiries.
Antitrust, cybersecurity, and international trade
- Assisting clients with price-gouging concerns, advertising and claims substantiation, and other consumer-protection issues related to the coronavirus pandemic.
- Assisting companies in cyber preparedness for COVID-19 cyber threats (cyber scams, phishing, and cyber-attacks) and helping mitigate the increase in cyber risk with a review of incident response and business continuity planning.
- Assisting companies responding to new cyber-attacks by actors taking advantage of the COVID-19 pandemic.
- Advising companies on how to mitigate the cyber risk resulting from an increase in employees working remotely, including through implementing policies and technical controls and employee communication strategies.
- Assisting clients on trade regulations during the coronavirus pandemic, including U.S. border cargo operations, tariff suspensions, import and related regulatory requirements for personal protection equipment (PPE) and medical devices, and critical infrastructure status for manufacturing supply chains.
- Advising clients on federal tax issues arising from the coronavirus pandemic, including the tax impact of new federal legislation designed to mitigate the economic effects, business disruption issues, and tax considerations for insolvent and troubled businesses.
- Advising clients on federal tax issues related to the effect of the coronavirus pandemic on supply chains, including deducting expenses, shutdown issues, net operating losses, and the impact on advance pricing agreements.
- Assisting clients with mandated provisions in pending legislation and how they relate to health benefit plans during the coronavirus pandemic.
- Providing advice on price-gouging conduct by competitors.
- Defending company practices targeted for class actions, including subscription-based memberships and tuition.
- Advising clients on the class action risk associated with food and consumer products processing, supply chain, and labeling issues in light of COVID-19.
- Assessing threatened class actions attacking measures employers have taken to combat COVID-19.
- Advising clients on mitigation of Telephone Consumer Protection Act suit risk due to new methods of consumer communication.
- Assisting companies with addressing anticipated privacy class actions arising from cyber-attacks caused by actors taking advantage of the COVID-19 pandemic.