Alston & Bird’s Coronavirus Flash provides updates on policy and regulatory actions under consideration across many important industries being monitored by our teams. Links to key government and legal resources are provided throughout the report.
UPDATED 9:00 AM ET ON FRIDAY, MAY 15, 2020
The Latest News
- U.S. COVID-19 cases exceed 1,411,002 and 86,571 U.S. deaths. (Source: CDC) (Updated 5/15/20)
- U.S. stock market: On Thursday the major U.S. benchmarks all posted gains, with the Dow rising 377 points, the S&P 500 up 32 points, and the Nasdaq gaining 80 points.(New)
- The Department of Labor released the weekly unemployment report showing that 2.98 million Americans applied for initial unemployment benefits last week, bringing the eight-week total to 36.5 million. (New)
- The President announced changes to the supply and maintenance of the strategic national stockpile (SNS), which will include new requirements for a 90 day supply of testing, ventilators, respirators, and other materials in preparation for future COVID-19 resurgence. The SNS will maintain flow of supplies through contracts with companies and will collect information from manufacturers and hospitals to track need and availability. The President also released an executive order to increase the development of domestic medical supply manufacturing through an International Development Finance Corporation loan program. (5/14/20) (New)
COVID-19 Federal Legislation
- Bill 4.0: The House of Representatives will vote today on the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, it’s $3 trillion aid package which the President described as “dead on arrival” in referencing its chances of consideration in the Senate. Regardless its chances for further action, the HEROES Act serves as the official opening of negotiations for phase 4.0 in emergency relief legislation. Senate Majority Leader Mitch McConnell (R-KY) continues to downplay the need for action any time soon.
- One issue gaining considerable Senate interest is liability protection for employers. The U.S. Chamber of Commerce and other business groups are seeking limits on lawsuits from employees and customers who contract COVID-19 as the nation transitions to reopening. Senate Judiciary Chairman Lindsay Graham has stated that the next relief package must include liability protection, and President Trump has warned of “litigation heaven.”
- For the full details on the HEROES Act, H.R. 6800:
- Bill 3.5: Paycheck Protection Program and Health Care Enhancement Act, (R. 266) was enacted on April 24. Also available are a section-by-section summary and an overview of the health care provisions.
- A&B detailed summaries are below:
- A&B Summary – 5 Small Business Provisions
- A&B Summary – 5 Health Care Enhancement Provisions
- Bill 3.0: Coronavirus Aid, Relief, and Economic Security (CARES) Act, (R. 748) passed on March 27. A congressional section by section summary is available here.
- A&B detailed summaries are below:
- A&B Quick Guide to the health care Provider Relief Fund General Distribution Attestation and Application Process – (New 5/12/20)
- A&B Summary of oversight and enforcement provisions in the CARES Act
- Congress has passed three coronavirus emergency response bills and the first two are below:
- Bill 1.0: Coronavirus Preparedness and Response Supplemental (CPPRS) (R. 6074) passed on March 5
- Bill 2.0: Families First Coronavirus Response Act (FFCRA) (R. 6201) passed on March 18
COVID-19 State Legislation
- New legislative resource to track how states and localities are responding to the COVID-19 pandemic with emergency relief programs for small and medium-sized businesses. Follow our tracker here. (Updated 5/5/20)
Transition to “Reopening”
- State/Other Actions
- For the latest information on state reopening decisions, see A&B 50-State Openings tracker – updated in each A&B Coronavirus Flash Update. (Updated 5/13/20)
- A&B’s Labor & Employment Group identifies issues likely to arise as workers are invited to return to their jobs and that employers may confront in developing return-to-work action plans in this advisory. (4/22/20)
- Administration Actions
- The CDC released (5/14/20) guidelines and decision tools for reopening:
- FEMA released an Exercise Starter Kit with sample documents organizations can use to conduct planning workshops to navigate the complexities of returning to full operations during the COVID-19 pandemic. (5/12/20) (New)
- The FDA announced that it was working with the CDC to develop a process to resume on-site facility surveillance inspections consistent with the criteria announced in the White House Guidelines for Opening Up America Again. (5/11/20)
Federal Communications Commission
- The Federal Communication Commission (FCC) approved the sixth set of COVID-19 Telehealth Program Applications. FCC approved an additional 33 funding applications, totaling $8.36 million. This brings the total COVID-19 Telehealth Program to 82 health care providers in 30 states for a total of $33.26 million in funding. (5/13/20) (New)
- The FCC announced that 774 broadband and telephone providers have extended a pledge to assist residential and small business customers that are impacted by the COVID-19 pandemic. The commitment now extends through June 30. (5/14/20) (New)
- FCC also extended (5/14/20) temporary waivers through June 30 for Telecommunications Relay Service providers. (New)
Department of Health and Human Services
- The Department of Health and Human Services (HHS) Coronavirus toolkit page has been updated. (Updated 5/13/20)
- The Agency for Healthcare Research and Quality (AHRQ) announced a new funding opportunity that will award $5 million to support novel, high-impact studies that evaluate the responsiveness of the U.S. health care system to the COVID-19 pandemic. (5/14/20) (New)
- Substance Abuse and Mental Health Services Administration announced a $40 million grant program to prevent suicide and support states and communities during the COVID-19 pandemic. (5/13/20) (New)
- HHS and the Department of Defense (DOD) announced the award of a $138 million contract to ApiJect Systems America to expand production capability for prefilled syringes for a future COVID-19 vaccine. (5/12/20)
- The HHS Administration for Community Living updated its COVID-19 FAQs for Title VI grantees. (Updated 5/11/20)
- Despite enforcement delays final interoperability rules will have significant impact on health care participants. To learn more about these complex rules read this A&B advisory. (5/8/20)
- HHS has a tracking feature that allows public viewing of all COVID-19 HHS grant and cooperative agreement awards on its website. The grants were distributed through programs in the ACF, ACL, ASPR, CDC, DHHS/OS, HRSA, IHS, NIH, and SAMHSA. (Updated 5/13/20)
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
- The Centers for Medicare and Medicaid Services (CMS) latest news alerts.
- And for the latest COVID-19 related CMS guidance visit the CMS Current Emergencies webpage.
- CMS announced a call for nominations for the new contractor-led Coronavirus Commission on Safety and Quality in Nursing Homes. The Commission will conduct a comprehensive assessment of the overall response to the COVID-19 pandemic in nursing homes and will inform immediate and future actions to address the virus in order to safeguard the health and quality of life for this vulnerable population of Americans. (5/14/20) (New)
- CMS released a new Toolkit on actions by states and other organizations to mitigate COVID-19 prevalence in nursing homes. The toolkit is not CMS guidance but is comprised of best practices from front line health care providers, Governors’ COVID-19 task forces, associations, and experts. (5/14/20) (New)
- CMS provided guidance regarding Medicaid Managed Care Options in responding to COVID-19. (5/14/20) (New)
- CMS released a new FAQ on Price Transparency: Requirements for Providers to Make Public Cash Prices for COVID-19 Diagnostic Testing. (5/13/20) (New)
- CMS has posted a video to review the most common questions regarding telehealth visit benefits under the 1135 waiver authority during the public health emergency. (5/8/20)
- For a better understanding of the COVID-19 telehealth waivers and regulatory flexibilities, review this new A&B Guide. (5/12/20)
- A&B’s Health Care and Litigation Groups explore how to take advantage of remote health care now and prepare for continued telehealth operations after the pandemic ends in this advisory. (4/29/20)
- CMS has updated its list of blanket waivers. (5/11/20)
- A&B Health Care Public Policy Practice provides a detailed summary of the CMS interim final rule. The interim final rule is intended to provide additional flexibilities for individuals and entities that provide health care services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries to assist in the response to threats associated with COVID-19. Comments are due July 7, 2020. (5/6/20)
HHS/CMS/HRSA CARES Act Provider Relief Funds
- HHS announced that HRSA has awarded $15 million in five health workforce programs to 159 organizations to increase telehealth capabilities in response to the COVID-19 pandemic and as authorized by the CARES Act. (5/14/20) (New)
- CMS has released data on providers and suppliers who have received payments through the Accelerated and Advance Payment Program. (5/10/20)
- State by state data and information organized by provider type is posted here. (Updated 5/10/20)
- Specific provider and supplier data, organized by state, is posted here (Zip file).
- HHS announced it was disbursing another $22 billion in CARES Act Provider Relief Funds last Friday for hospitals in “hot spots” or COVID-19 high impact areas ($12 billion) and for rural providers ($10 billion). The CMS Provider Relief Fund webpage has been updated and additional portals opened: (5/2/20)
- A&B Quick Guide to the health care Provider Relief Fund General Distribution Attestation and Application Process – (Update 5/12/20)
- Provider Relief Funds general distribution FAQs (5/8/20)
- The CARES Provider Relief hotline is (866) 569-3522.
- The Health Resources and Services Administration launched the COVID Uninsured Portal allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to request claims reimbursement.
Food and Drug Administration (Drugs and Devices)
- FDA provides a daily roundup on COVID-19 related actions. The latest update is here (Updated 5/14/20), and here is a listing of all announcements.
- FDA maintains its COVID-19 FAQs for the general public. (Updated 5/14/20)
- The agency also maintains a public database of drug shortages. (Updated 5/8/20)
- The FDA will host a Virtual Town Hall on May 15 for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs. (New)
- The FDA issued an emergency use authorization for infusion pumps and infusion pump accessories. (5/13/20) (New)
- The FDA posted a new webpage with information on the use of thermal imaging systems. (5/13/20) (New)
- The FDA announced two new guidance documents to streamline the process for submitting applications to initiate studies for new drugs and biological products related to COVID-19. The first provides information on investigational new drug applications and the second on later stage clinical trials. (5/11/20)
- The FDA announced updated guidance for clinical laboratories, commercial manufacturers, and FDA staff to accelerate the availability of COVID-19 tests. (5/11/20)
- The FDA announced new guidance to provide recommendations regarding post marketing adverse event reporting during the pandemic. (5/11/20)
- The FDA updated its FAQs on manufacturing, purchasing, importing, and donating face masks.
- The FDA has posted FAQs for consumers on Remdesivir and COVID-19. (5/7/20)
- FDA issued guidance to clarify the scope of the public health emergency exemption and exclusion under the Drug Supply Chain Security Act to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19. (4/30/20)
- Review this A&B advisory for more information about the FDA’s new guidance. (5/5/20)
Food and Drug Administration and United States Department of Agriculture (Food-Related)
- USDA announced a partnership with national and regional food suppliers a program to purchase up to $3 billion in produce and products and to assist nonprofit food organizations. (5/8/20)
National Institutes of Health
- The National Institutes of Health (NIH) announced it was beginning clinical trial testing of hydroxychloroquine and azithromycin to treat COVID-19. (5/14/20) (New)
- NIH updated its COVID-19 Treatment Guidelines. (Updated 5/12/20).
Health Resources and Services Administration
- HRSA provides COVID-19-related information, resources, and FAQs here.
Department of Homeland Security/FEMA
- The Department of Homeland Security (DHS) issues a weekly roundup of its response to COVID-19. (Last updated 5/11/20)
- The Department of Defense, in coordination with FEMA and HHS, signed a $134 million contract award with the Federal Resources Supply Company to provide PPE kits for medical personnel at over 15,000 nursing home locations. (5/13/20) (New)
- DHS announced a temporary final rule that will be issued on May 14 that will temporarily remove certain limitations on employers, or U.S. agents, seeking to hire certain H-2B workers already in the United States to provide temporary labor or services essential to the U.S. food supply chain, and certain H-2B workers, who are essential to the U.S. food supply chain, seeking to extend their stay. (5/12/20)
- The DHS Cybersecurity and Infrastructure Security Agency (CISA) issued an announcement with the FBI to raise awareness of the threat to COVID-19-related research. Malicious actors have been observed attempting to identify and illicitly obtain valuable intellectual property (IP) and public health data related to vaccines, treatments, and testing from networks and personnel affiliated with COVID-19-related research. (5/13/20) (New)
- CISA previously released a fact sheet to warn of disinformation related to COVID-19. (5/8/20)
- President Trump signed an executive order temporarily “pausing,” for period of 60 days, certain U.S. immigration processes. The President noted he would revisit the issue after 60 days and depending on the economy may choose to extend the suspension. (4/22/20)
- Review this A&B advisory for more information on the order, who it applies to, who is exempted, and what employment-based visas are affected. (4/28/20)
Department of Justice/Federal Trade Commission/Litigation Consumer Protection/Anti-fraud
- On May 8, the FTC announced it is soliciting comments on whether it should make changes to its 2009 “Health Breach Notification Rule,” which mandates the disclosure of data breaches by firms that handle personal health data but who are not covered by the Health Insurance Portability and Accountability Act, or HIPAA, which has its own breach notification rules. The rule has not been invoked in the past decade, but as consumers are increasingly turning to telehealth, more companies may be covered by this rule. FTC seeks comments on the rule's definition and whether companies should be required to report data breaches sooner as well as whether and how the rule should address any developments in health care products or services related to COVID-19. These comments will be accepted for 90 days after the rule review notice is published in the Federal Register.
- The Department of Justice announced the first enforcement action regarding alleged PPP fraud. The DOJ alleged that two defendants falsely claimed to have dozens of employees at several locations to get more than $500,000 in forgivable loans. (5/5/20)
- The impact of the coronavirus pandemic may be a scheduling challenge for the courts, but bankruptcy cases remain active. For an examination of the implications of a bankruptcy case where the majority shareholder seeks to enforce its blocking rights, read this A&B advisory. (5/8/20)
- Higher education protected students’ and employees’ health by closing their campuses and moving – virtually overnight – to online learning. Now they face high-risk class actions from students and their parents. A&B’s Colleges & Universities Team provides insight into current litigation in this advisory. (4/30/20)
Department of Labor/OSHA
- The Department of Labor’s Employment and Training Administration announced the publication of updated guidance, including FAQs, regarding the Pandemic Emergency Unemployment Compensation program. Under the CARES Act, the DOL created a temporary federal unemployment compensation program that provides funding to states. (5/14/20) (New)
- The Occupational Safety and Health Administration (OSHA) announced an alert for rideshare, taxi, and car service safety during the COVID-19 pandemic. (5/14/20) (New)
- OSHA also announced an alert listing safety tips employers can follow to protect dental industry workers from COVID-19. (5/11/20)
Small Business Administration
- Small Business Administration (SBA) – In response to the CARES Act requirements, the SBA formally launched its Paycheck Protection Program (PPP) for small businesses. (4/3/20)
- The SBA updated its statistics on Round 2 loans showing that it had made 2.71 million loans totaling $193.659 billion. The average loan size is $71,254. (Updated 5/14/20).
- The SBA previously released Round 2 data of the PPP. (5/8/20)
- The SBA and Treasury updated their FAQs on the Paycheck Protection Program. (Updated 5/13/20)
- The FAQs clarified that any borrower that, together with its affiliates, received PPP loans with an original principal amount of less than $2 million will be deemed to have made the required certification concerning the necessity of the loan request in good faith.
- The FAQs also clarified that for borrowers with loans greater than $2 million that are deemed by SBA to lack the requisite necessity, the borrower may repay the loan without penalty.
- The SBA also extended the repayment date for the safe harbor to May 18, 2020.
- The SBA issued an interim final rule for the PPP, relating to electric cooperatives. (5/14/20) (New)
- The SBA issued an interim final rule related to the PPP, covering issues related to partner compensation, seasonal employers, additional loan disbursements, and reporting of disbursements. (5/13/20) (New)
- Review this A&B advisory for information on relief under the CARES Act for fund managers. (5/5/20)
- The SBA and Treasury announced that they would review all PPP loans over $2 million, in addition to other loans as appropriate, to ensure that applicants meet eligibility criteria. (4/28/20)
- A&B’s White Collar, Government & Internal Investigations Team summarizes the latest stimulus addition and emerging enforcement developments related to the certification, receipt, and use of PPP funds, including for banks processing the related loans, in this advisory. (4/30/20)
Department of Treasury/IRS/Federal Reserve
- The Department of Treasury website for CARES Act programs, including specific sections on assistance for American workers and families, small businesses, state and local governments, and preserving jobs for American industry.
- The Federal Reserve Board issued a Report on the Economic Well-Being of U.S. Households. (5/14/20) (New)
- The Department of Treasury announced that the Federal Reserve Bank of New York would begin purchasing shares of eligible US-listed exchange-traded funds and eligible corporate bonds through the Primary and Secondary Market Corporate Credit Facilities (PMCCF and SMCCF). (5/12/20)
- The Department of Treasury announced that it had approved over $25 billion in assistance to 352 applicants under the Payroll Support Program, including all the major passenger air carriers. Details on the recipients and assistance provided is available here. (5/12/20)
- The Federal Reserve announced that it published updates to the term sheet for the Term Asset-Backed Securities Loan Facility (TALF) and identified the information that would be disclosed monthly for TALF and the Paycheck Protection Program Liquidity Facility, including the name of each participant, the amounts borrowed, and the value of pledged collateral. The Federal Reserve also issued FAQs on TALF. (5/12/20)
- The Federal Reserve announced updates to the term sheet for the Municipal Liquidity Facility (MLF) to provide pricing and other information. The Federal Reserve also issued FAQs on MLF.
- The Federal Deposit Insurance Corporation (FDIC) announced a notice of proposed rulemaking to mitigate the deposit insurance assessment effects of participating in the Paycheck Protection Program, the Paycheck Program Lending Facility, or Money Market Mutual Fund Liquidity Facility. (5/12/20)
- The IRS announced guidance to allow temporary changes to cafeteria plans to extend the claims period for health flexible spending arrangements and dependent care programs. (5/12/20)
- The Federal Reserve announced an expansion of the scope and eligibility for the Main Street Lending Program, essentially creating a third option to help credit flow to small and medium-sized businesses. (4/30/20)
- FAQs regarding the Main Street Lending Program were released. (4/30/20)
- For more information on how to chart a course through all three Main Street Lending Program options, read this A&B advisory. (5/6/20)
- The Consumer Financial Protection Bureau issued a statement on supervisory and enforcement practices regarding Regulation Z billing error resolution timeframes in light of the COVID-19 pandemic. (5/13/20) (New)
- The Consumer Financial Protection Bureau, Federal Housing Finance Agency (FHFA), and Department of Housing and Urban Development (HUD) released a website providing consumers information on housing assistance. It includes a tool that allows homeowners and renters to determine if they live in a residence with a federally-backed mortgage. (5/12/20)
- The Environmental Protection Agency (EPA), with the U.S. Department of Agriculture, announced assistance to help 16 communities boost economic opportunities for their local farmers, while promoting clean air, safe water, open space, and healthy food choices. (5/14/20) (New)
- The EPA launched an app to easily identify disinfectants on List N, for use against SARS-CoV-2, and announced an expedited review process for additional disinfectants for List N that require applications and data review. (5/12/20)
- The EPA issued clarifying guidance for ethanol producers that generate tradeable credits (RINs) under EPA’s Renewable Fuel Standard (RFS), and that are also producing hand sanitizer. As RINs cannot be generated for hand sanitizer alcohol, this guidance specifies how producers should allocate energy usage in Efficient Producer Pathway (EP3) calculations for the production of fuel ethanol and hand sanitizer alcohol. (5/11/20)
- The Federal Housing Finance Agency announced that Fannie Mae and Freddie Mac are making available a new payment deferral, allowing borrowers who are able to return to making their normal monthly mortgage payment to repay their missed payments at the time the home is sold, refinanced, or at maturity. (5/13/20) (New)
- HUD announced the allocation of a third wave of CARES Act funding totaling $1 billion through the Community Development Block Grant (CDBG) program. (5/11/20)
- Review this A&B advisory for information regarding the expansion of Ginnie Mae’s Pass-Through Assistance Program to multifamily mortgage-backed securities issuers. (5/12/20)
- For an update on recent key developments in privacy, data security, and all things cyber, read this A&B Digital Download. (5/12/20)
- The S. Patent and Trademark Office announced (4/28/20) that it would further extend certain patent and trademark deadlines to June 1, 2020, given the ongoing effects of the COVID-19 pandemic. These extended deadlines apply to those situations identified in the USPTO’s March 31, 2020, guidance, such as responses to Office Actions.
- For more detail, read Alston & Bird’s advisory explaining how and when to claim these extensions. (4/2/20)
- The Department of Transportation (DOT) Federal Motor Carrier Safety Administration published a final rule updating hours of service rules for commercial motor vehicle drivers to increase safety on America’s roadways. (5/14/20) (New)
- DOT announced that it was issuing a second enforcement notice regarding airline ticket refunds and a notice of adjustments to service obligations to allow carriers to reduce their service obligations. (5/12/20)
- DOT and the Federal Aviation Administration (FAA) updated their interim occupational health and safety guidance for air carriers and crews. (5/11/20)
Trade and International Business Issues COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle
- G20 trade ministers endorse steps to mitigate COVID-19 impacts. G20 trade and investment officials convened virtually on May 14, endorsing short- and long-term “collective actions” countries could take to combat economic harm caused by the COVID-19 pandemic. Short-term recommendations include enhancing trade regulation, facilitation, and transparency and to improve the operation of logistics networks, according to a joint statement. Longer-term actions are initiatives to support the multilateral trading system, “building resilience in global supply chains” and strengthening international investment. (New)
- Travel limitations hitting CBP’s Budget. The travel limitations imposed to slow the spread of COVID-19 has resulted in a big hit to CBP’s budget due to the decrease in corresponding user fees, said Thomas Overacker, CBP executive director, Cargo and Conveyance Security, on a virtual National Association of Foreign-Trade Zones conference on May 12. Also, about $72 million in importers’ payment were deferred according to officials. CBP is actively looking for ways to cut spending as a result. (New)
- WCO, WHO Issue Updated COVID-19 Medical Supplies Classification Guide. The World Customs Organization, with help from the World Health Organization, updated its list of tariff classifications for COVID-19 medical supplies to include priority medicines. The indicative list aims at assisting Customs and economic operators in classifying these medicines. (New)
- FDA Document Submission for Imports During COVID-19 Pandemic. If a request for documents is received from FDA, filers and/or importers are strongly encouraged to submit product labeling along with regularly submitted entry documents (commercial invoice, packing list, way bill, etc.). Submission of labeling will help expedite the admissibility process during this pandemic. This can be done electronically via the FDA Import Trade Auxiliary Communication System (ITACS). See U.S. Customs message here. (5/8/20) (New)
- Examining the strong performance of environmental, social, governance (ESG) funds, the developments in the UK and Europe and more are investigated in the A&B advisory. (5/8/20)
- With everyone focused on COVID-19, this A&B advisory analyzes the implications of Brexit on cross-border litigation in Europe. (5/5/20)
- For a 50-state review of business interruption insurance related issues see this new COVID-19 Insurance Litigation and Regulatory Issues tracker. The tracker is updated weekly. (Updated weekly - 5/10/20)
- The pace of new business income coverage claims flooding state and federal courts nationwide has not slowed over the last few weeks. In addition to new case filings, a group of insurance industry trade groups led by the American Property Casualty Insurance Association has filed an Amici Curiae Brief in Tambellini v. Erie Insurance Exchange, urging the Pennsylvania Supreme Court to deny Plaintiff’s Emergency Application for Extraordinary Relief, which seeks to bypass the ordinary course trial court procedures and catapult Plaintiff’s claims straight to the Pennsylvania Supreme Court under the court’s infrequently-used King’s Bench Powers.
For background and the most up-to-date information, please visit the Centers for Disease Control and Prevention Coronavirus Disease 2019 website: HERE. The additional federal agency links are provided by the White House Coronavirus Task Force: U.S. Department of Health and Human Services:
Centers for Disease Control and Prevention:
What you should know:
Information for Businesses:
Information for Travel and Transportation:
Information for Health Care Providers, First Responders, and Research Facilities:
Information for Law Enforcement:
Information for Families and Households:
Information for Schools and Childcare Providers:
Information for Community Events and Gatherings:
Agency Resources and Information:
Download PDF of the Flash Update