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.
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UPDATED 9:00 AM ET ON MONDAY, JULY 20, 2020
The Latest News
- U.S. COVID-19 cases exceed 3,754,255 and 137,696 U.S. deaths. (Source: CDC) (Updated 7/20/20)
- U.S. stock market: On Friday the markets posted mixed results for the day, with the Dow dropping 62 points, while the S&P 500 gained 9 points and the Nasdaq rose 29 points. (New)
- The FDA authorizes the first “pooled testing” by reissuing an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. This is the first test approved for use with pooled samples. (7/18/20) (New)
- The Kaiser Family Foundation released new analysis on COVID-19 test list prices showing that COVID-19 diagnostic and antibody test list prices range from $20 to $850 at large hospitals nationwide. The analysis looked for pricing at the 2 largest hospitals in each state plus DC and of those 102 hospitals, 78 have posted prices for COVID-19 diagnostic tests. There were 134 distinct prices for diagnostic tests, which ranged between $20 and $850 (median of $127). 51% of test chargers were between $100 and $199, with 19% priced above $200. 29 of the 102 hospitals posted prices of COVID-19 antibody tests. There were 38 distinct prices for antibody tests, which ranged between $36 and $300. 82% of posted prices were less than $150. (7/13/20) (New)
- The Department of Treasury has approved the expansion of the Main Street Lending Program to nonprofit organizations including educational institutions, hospitals, and social service organizations. The Main Street nonprofit loan terms generally mirror those for Main Street for-profit business loans, including the interest rate, principal and interest payment deferral, five-year term, and minimum and maximum loan sizes. Nonprofits will be eligible for two loan options, and the chart below has additional details on the final terms. There are two loan options listed below: (7/17/20) (New)
- Nonprofit Organization New Loan Facility Term Sheet (7/17/20) (New)
- Nonprofit Organization Expanded Loan Facility Term Sheet (7/17/20) (New)
- HHS announced $10 billion in a second round of Provider Relief Fund aid to high impact COVID-19 hospitals. Distributions will start to go out next week. (7/17/20) (New)
- Methodology has changed from Round 1. Eligible hospitals are those:
- With over 161 COVID-19 admissions between 1/1 and 6/10/2020; or
- With one admission per day; or
- That experienced “a disproportionate intensity of COVID admissions” (exceeding the average ratio of COVID admissions per bed).
- Hospitals will be paid $50,000 per eligible admission (reduced from $76,975 per eligible admission).
- State-by-state breakdown (7/17/20) (New)
- List of recipients (7/17/20) (New)
- Bill 4.0: The clock is ticking with the Senate returning this week with 8 days before its scheduled August break, and the House is due to start its August recess in four days. This creates an extremely narrow window to enact a 4.0 emergency stimulus package before the August congressional recess departure which the leadership of both bodies have said is their goal. These scheduled departures may slip, but probably not by much since both parties have their presidential nominating conventions later in August. If necessary, the final negotiations could be delayed to September, but neither party wants to leave important emergency legislation to the final legislative weeks before the fall election. (New)
- Since the House of Representatives passed its 4.0 proposal, the HEROES Act, in May, the focus is on Senate Majority Leader Mitch McConnell, who has stated he will release his proposal this week. Leader McConnell has indicated his proposal will include school funding to aid in reopening, liability protections for businesses, hospitals, and schools, an extension of the Paycheck Protection Program, and a payroll tax cut. McConnell has also stated the proposal will include additional funding for COVID-19 testing, but the Administration signaled over the weekend that they might oppose additional testing funds. Once the Senate GOP proposal has been released, the negotiations between the two bodies will begin in earnest. (7/20/20) (New)
- The HEROES Act was the first formal offer on a new emergency stimulus bill, 4.0: For the full details on the HEROES Act, H.R. 6800, which passed the House on May 15:
- The HEROES Act text is available here.
- A 1-pager and 71 page section-by-section summary are available here.
- And an outline of the state and local funding provisions is here.
- The Paycheck Protection Flexibility Act, H.R. 7010, was enacted on June 5. To learn more, see this A&B Summary of the Paycheck Protection Flexibility Act. (6/5/20)
- 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:
- 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.
- 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
Transition to “Reopening”
- Administration Actions
- The Administration has reversed its position on allowing international students to study in the U.S. (7/15/20) (New)
- The CDC updated or released guidance for reopening:
- Discontinuing Isolation for Individuals with COVID-19 in Non-Healthcare Settings (7/17/20) (New)
- Toolkit and guidance for colleges and universities (7/17/20) (New)
- When to wear gloves for the general public (7/16/20) (New)
- When to quarantine if you have been exposed (Updated 7/15/20)
- Operators of Public Pools, Hot Tubs, and Water Playgrounds (7/15/20) (New)
- Social distancing for indoor and outdoor spaces (7/14/20) (New)
- Reopening graphics and buttons (7/14/20) (New)
- Reopening Toolkits:
- General Public (7/10/20) (New)
- Young Adults (7/10/20) (New)
- School Administrators (7/10/20) (New)
- Youth Sports (7/10/20) (New)
- Shared and Congregate Housing (7/10/20) (New)
- Businesses and Workplaces (7/10/20) (New)
- Travelers (7/10/20) (New)
- State/Other Actions
- For the latest information on state reopening decisions, see A&B 50-State Reopening Tracker - updated in each A&B Coronavirus Flash. (Updated 7/17/20)
- Business Insurance News
- The Maryland Insurance Administration issued Bulletin 20-28, which recognizes that while the Administration has requested that property & casualty insurers make reasonable accommodations to avoid cancellation of policies for non-payment of premiums due to COVID-19, that most admitted insurers have complied with the Administration’s request, but insurers cannot be expected to provide coverage in the absence of premium payments indefinitely. An upcoming Bulletin will provide additional information regarding this required filing. (7/2/20)
- Pagnol et Cie., Inc dba Chez Panisse, a well-known Berkeley restaurant filed suit against its insurer AMCO Insurance Company, an affiliate of Nationwide Mutual Insurance Co. in the Northern District of California. The Complaint alleges AMCO “swiftly denied” its claim for business interruption coverage relating to its suspension of in-house dining in compliance with certain statewide closure orders. Plaintiff alleges that compliance with the state “orders has caused direct physical loss of Chez Panisse’s insured property in that the property has been made useless and/or uninhabitable. The case is Pagnol et Cie., Inc. v. AMCO Ins. Co., No. 4:20-cv-04488 (N.D. Cal.). (7/7/20)
Department of Health and Human Services
- HHS has a tracking feature that allows public viewing of all COVID-19 HHS grants 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 7/16/20)
- HHS released information and FAQs on its new hospital data reporting protocols. (7/10/20) (New)
- HHS announced a large-scale procurement of FDA-authorized rapid point-of-care diagnostic test instruments and tests to be distributed to nursing homes. (7/14/20) (New)
- The HHS Office of Biomedical Advanced Research and Development Authority (BARDA) announced jointly with the Department of Defense a partnership with Smiths Medical, Inc. to expand the capacity to manufacture safety needles and syringes. (7/14/20) (New)
- HHS Substance Abuse and Mental Health & Safety Administration (SAMHSA) announced the adoption of the revised Confidentiality of Substance Use Disorder Patient Records regulation, 42, CFR Part 2. (7/13/20) (New)
- HHS released May and June testing plans for each state, territory, and some localities. (7/10/20)
- HHS has released a summary chart to understand what private insurance plans are required to cover when it comes to COVID-19 testing. (7/7/20) (New)
- Vice President Mike Pence and HHS Secretary Alex Azar reassured governors recently that the Administration planned to extend the public health emergency (PHE) declaration when it expires on July 25. If extended it will be the second extension since the coronavirus emergency was declared in January. Public health emergency declarations are often extended (each extension is for 90 days) months beyond the dates of initial disasters, but the coronavirus emergency has been unique due to its nationwide impact and the number of waivers and regulatory flexibilities extended for the duration of the PHE. Confirming the pledges made by Vice President Pence and Sec. Azar, the HHS communications director, Michael Caputo tweeted "Enough already. @HHSGov expects to renew the Public Health Emergency due to COVID-19 before it expires." (7/7/20)
- The HHS Office of Civil Rights maintains a list of COVID-19 complaint resolutions. (Updated 7/8/20)
HHS/CDC/CMS/HRSA CARES Act Provider Relief Funds
- HHS - the CARES Act Provider Relief Fund (PRF) webpage (Updated 7/17/20)
- And the PRF FAQs (Updated 7/17/20) have been updated and capture numerous modifications.
- HHS announced $10 billion in a second round of Provider Relief Fund aid to high impact COVID-19 hospitals. Distributions will start to go out next week. (7/17/20) (New)
- Methodology has changed from Round 1. Eligible hospitals are those:
- With over 161 COVID-19 admissions between 1/1 and 6/10/2020; or
- With one admission per day; or
- That experienced “a disproportionate intensity of COVID admissions” (exceeding the average ratio of COVID admissions per bed).
- Hospitals will be paid $50,000 per eligible admission (reduced from $76,975 per eligible admission).
- State-by-state breakdown (7/17/20) (New)
- List of recipients (7/17/20) (New)
- The CDC has posted an updated dataset of provider recipient specific payment from the Provider Relief Fund general distribution high impact targeted allocation and/or rural targeted allocation. The dataset includes who has attested to receiving one or more payments and agreed to the terms and conditions as of July 160. (Updated 7/15/20)
- A&B Hospital provisions from all 4 bills tracker (Updated 7/19/20)
- A&B Provider Relief Fund Disbursements tracker (Updated 7/192/20)
Centers for Disease Control and Prevention
- The Centers for Disease Control and Prevention (CDC) COVIDView Weekly Summary is available. (Updated 7/17/20)
- The CDC weekly COVID forecast. (Updated 7/15/20)
- The CDC S. testing data. (Updated 7/18/20)
- The CDC FAQs on testing for SARS-CoV-2. (7/18/20) (New)
- The FAQs include a full list of laboratories that have been removed from the list of laboratories that had notified FDA that they had developed and validated diagnostic tests. Any laboratory on this list has been removed from the notification list because FDA has determined that there are significant problems with its test that cannot be, or have not been, addressed in a timely manner and should no longer be used. (7/18/20) (New)
- CDC webpage for all COVID-19 toolkits, videos, print resources, PSAs, FAQs and web resources. (7/17/20) (New)
- CDC updated its FAQs for laboratories. (Updated 7/16/20)
- CDC Director Robert Redfield and HHS Chief Information Officer Jose Arrieta provide an update on the COVID-19 hospital data collection. (7/15/20) (New)
- The CDC has released new guidance for:
- Optimizing the supply of eye protection in healthcare settings (7/15/20) (New)
- Interim guidance for EMS and Emergency Communications Centers (Updated 7/15/20)
- Healthcare worker guidance on testing (7/14/20) (New)
- Infection control recommendations for healthcare personnel (Updated 7/14/20)
- Fact Sheet on PPE best practices for healthcare personnel (7/13/20)
- How to use PPE (Updated 7/13/20)
- Graphic on how to collect anterior nasal swab sample (7/12/20) (New)
- Transferring Patients and Supplies between facilities (7/12/20) (New)
Centers for Medicare & Medicaid Services
- The Centers for Medicare and Medicaid Services (CMS) latest news alerts. (Updated 7/10/20)
- For the latest COVID-19 related CMS guidance and FAQs visit the CMS Current Emergencies webpage. (Updated 7/15/20)
- CMS updated its COVID-19 toolkit for nursing homes. (Updated 7/15/20)
- CMS updated its FAQs on Medicare Fee-for-Service Billing (Updated 7/15/20)
- CMS State Medicaid Director letter on extension of the deadline for ensuring compliance with the Home and Community-Based Settings regulation. (7/14/20) (New)
- CMS updated its FAQs on exceptions for dialysis facilities affected by COVID-19. (Updated 7/14/20)
Food and Drug Administration
- FDA provides a daily roundup on COVID-19 related actions. (Updated 7/17/20)
- FDA updated its FAQs on Testing for SARS-CoV-2 relating to the development and performance of tests for SARS-CoV-2. (Updated 7/10/20)
- FDA maintains its COVID-19 FAQs for the general public. (Updated 7/10/20)
- FDA webpage for health professionals. (Updated 7/6/20)
- The agency also maintains a public database of drug shortages. (Updated 7/10/20)
- FDA webpage on Coronavirus Treatment Acceleration Program (CTAP) (Updated 7/14/20)
- The FDA reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. This is the first test approved for use with pooled samples. (7/18/20) (New)
- The FDA has added Dexamethasone Sodium Phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacy compounders. (7/14/20) (New)
- The FDA has issued warning letters for unapproved products COVID-19 products to:
- Health Beauty Love (New)
- Kegan Wellness (New)
- The FDA issued new emergency use authorizations (EUA) for:
- electroCare, Inc. (7/10/20) (New)
- University of California-San Francisco's Health Clinical Laboratories (7/9/20) (New)
- BioSewoom, Inc. (7/9/20) (New)
Small Business Administration
- The President signed into law 4116 which reauthorizes the Paycheck Protection Program (PPP) through August 8. This extends the PPP loan assistance for small businesses which had been set to expire on June 30 for another 6 weeks. (7/4/20)
- The SBA Paycheck Protection Program (PPP):
- The SBA updated its PPP process for 1502 reporting and lender processing fee payment protocols. (Updated 7/13/20)
- The SBA detailed data on PPP loans, including recipient names. (7/6/20)
Other Federal Agencies
- The US Department of Agriculture announced $153 million in grants for rural communities. (7/15/20) (New)
- The Federal Housing Administration announced streamlined single family servicing policy revisions. (7/14/20) (New)
- The Department of Justice (DOJ) announced a Texas man was charged with COVID-19 relief fraud having fraudulently obtained $1.1 million in Paycheck Protection Program (PPP) loans. (7/14/20) (New)
- The DOJ announced a general contractor was charged with COVID-19 relief fraud with allegedly submitting fraudulent PPP bank loan documents. (7/13/20) (New)
- The Department of Labor’s (DOL) Wage and Hour Division announced an enhancement to streamline the process for employers and employees using the Family and Medical Leave Act. (7/16/20) (New)
- The DOL Wage and Hour Division investigated the County of Carver, Minnesota for wrongfully denying paid leave due to a Coronavirus-related daycare closure. (7/16/20) (New)
- The DOL announced a series of July webinars on COVID-19 related sick leave for employers: (6/29/20)
- July 21, 1:00pm – 3:00pm EDT
- July 28, 1:00pm – 3:00pm EDT
- A&B offers a timely update on COVID-19 and what businesses need to know about corporate governance and the Insolvency Act of 2020. (7/6/20)
- The Department of Treasury has approved the expansion of the Main Street Lending Program to nonprofit organizations including educational institutions, hospitals, and social service organizations. The Main Street nonprofit loan terms generally mirror those for Main Street for-profit business loans, including the interest rate, principal and interest payment deferral, five-year term, and minimum and maximum loan sizes. Nonprofits will be eligible for two loan options, and the chart below has additional details on the final terms. There are two loan options listed below: (7/17/20) (New)
- Nonprofit Organization New Loan Facility Term Sheet (7/17/20) (New)
- Nonprofit Organization Expanded Loan Facility Term Sheet (7/17/20) (New)
- The IRS has released resources for securing tax data while working from home. (7/17/20) (New)
- The Department of Veterans Affairs announced an additional $400 million in relief funding for veterans at risk of homelessness. (7/16/20) (New)
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: What You Should Know:
- How to Protect Yourself & Others
- What to Do If You Are Sick with COVID-19
- Symptoms
- Facts about COVID-19
- Guidance Documents
- Information for Communities, Schools, and Businesses
- Workplaces during the COVID-19 Pandemic
- Cleaning and Disinfecting Your Facility
- Worker Safety and Support
- COVID-19 Critical Infrastructure Sector Response Planning
- General Business Frequently Asked Questions
- Information for Small Businesses
- SBA: COVID-19 Resources
- Treasury: Assistance for Small Businesses
- DOL: Guidance for Preparing Workplaces for Coronavirus
- DOL: COVID-19 and the American Workplace
- DOL: OHSA Resources for Workers and Employers on COVID-19
- WHO: Get Your Workplace Ready for COVID-19
- CISA: Risk Management for COVID-19
- CISA: Telework Guidance and Resources
- CISA: Guidance on the Essential Critical Infrastructure Workforce
Information for Travel and Transportation:
- Information for Travel
- Travel in the United States
- Public Health Considerations for Reopening Mass Transit During the Covid-19 Pandemic
- COVID-19 Travel Recommendations by Country
- Travel Restrictions to Prevent the Spread of Disease
- Airline Guidance
- Cargo Ship Guidance
- Maritime Resources
- Returning from International Travel
- Travelers Returning from Cruise Ship and River Cruise Voyages
- Travel: Frequently Asked Questions and Answers
- Travelers Prohibited from Entry to the United States
- Communication Resources for Travelers
- State: Travel Advisories
- State: Traveler’s Checklist
- State: Smart Traveler Enrollment Program
- DOT: FAQs from FTA Grantees Regarding COVID-19
- DOT: Expanded Emergency Declaration
- FAA: Guidance for Air Carriers and Crews
Alston & Bird Coronavirus Links
- Alston & Bird Coronavirus Response & Relief Web page
- To Subscribe to Alston & Bird Advisories
- For Alston & Bird COVID-19 Insights and Events
- Previous Alston & Bird Coronavirus Advisories (not included in the above)
- July 2
- July 1
- June 30
- June 15
- June 8
- June 5
- June 3
- June 1
- May 29
- May 22
- May 21
- May 18
- May 15
- May 12
- May 8
- Finance Advisory: ESG During the Coronavirus Crisis -- Should You Care?
- Health Care / Privacy & Data Security Advisory: Expansive Interoperability and Data-Sharing Requirements Require Attention Despite Delays in Enforcement
- Financial Restructuring & Reorganization Advisory: Delaware Courts Leery of Shareholder Obstruction
- May 6
- May 5
- May 4
- April 30
- April 29
- April 28
- April 24
- April 23
- April 22
- April 21
- Financial Advisory: Forbearance Agreements in the age of COVID-19 and National Shelter-in-Place Orders
- Antitrust / Mergers & Acquisitions / International Trade & Regulatory Advisory: COVID-19 Affect European Foreign Direct Investment Reviews: New EU Guidance Potentially Heralds Increased Protectionism
- April 20
- April 17
- "INSIGHT: Businesses Better Brace for Post-Coronavirus Lawsuits" Bloomberg Law
- Antitrust / Labor & Employment Advisory: Federal Antitrust Agencies Remind Businesses That Colluding on Labor Issues Remains Illegal During Pandemic
- Labor & Employment / Health Care / Corporate & Finance Advisory: Ramping Up: What Does Restarting Look Like?
- April 16
- April 15
- April 14
- April 13
- "As Pandemic Triggers Continuity Plans, What RIAs and BDs Should Ask Themselves," Financial Planning
- FDA & Environment Advisory: Cleaning Up After COVID-19? What You Need to Know Before You Manufacture, Import, or Sell Sterilizers, Sanitizers, Purifiers, and Disinfectants
- Securities Law Advisory: SEC Reminds Companies to Keep Their Disclosures Looking Forward
- April 10
- April 9
- Federal Tax Advisory: IRS Provides Partnerships a Mechanism to Claim Benefit of Retroactive CARES Act Provisions
- Financial Services Advisory: Agencies Update Their Interagency Statement on Reporting Loan Modifications
- Early Securities Class Actions Highlight COVID-19 Litigation Risk (Law360)
- FDA Compliance & Enforcement Advisory: FDA Issues New Guidance on Supply-Chain Disruption Notifications During COVID-19 Emergency
- Financial Restructuring & Reorganization Advisory: Protecting Recoveries in a Pandemic: What Creditors Can Do Right Now
- April 7
- April 6
- Antirust Advisory: Production and R&D Joint Ventures in a Pandemic: Reducing Antitrust Risk
- Financial Services Advisory: Regulatory Agencies Issue Mortgage Servicing Guidance and FAQs for the CARES Act
- White Collar, Government Investigations Advisory: CARES Act Follows Familiar Blueprint for Oversight and Enforcement
- April 3
- April 2
- April 1
- March 31
- March 30
- March 27
- Utilization of Electronic Signatures and Records: What You Need to Know
- SEC Extends Conditional Filing Relief to Companies Affected by COVID-19
- COVID-19: What It May Mean for Landlords and Lenders Under Their CRE Facility Agreements
- Congress Further Expands Medicare Telehealth Benefits with the CARES Act
- March 26
- March 25
- Is the COVID-19 Outbreak an “Act of God”? Why It May Matter for Your Contracts
- FDA and USDA Food Safety Response to COVID-19 & DHS “Critical Infrastructure” Classification of Food and Agriculture Sector
- Does Your Force Majeure Provision Extend to the Coronavirus?
- Competition Authorities Across Europe Relax Competition Law Enforcement During COVID-19 Outbreak
- COVID-19 Impacts Antitrust Deal Reviews: New Procedures and Delays
- March 24
- March 23
- March 20
- Employee Benefits & Executive Compensation Advisory: Coronavirus Impact on Health Benefits: A Deeper Dive
- FDA Compliance & Enforcement Advisory: FDA Temporarily Postpones Routine Domestic Inspections
- March 19
- Antitrust / Mergers & Acquisitions Advisory: COVID-19 Impacts Antitrust Deal Reviews: New Procedures and Delays
- Construction Advisory: Five Best Practices for Construction Industry Stakeholders During the Coronavirus Pandemic
- Labor & Employment Advisory: Employee Leave Requirements Under the Families First Coronavirus Response Act
- Labor & Employment / Health Care Advisory: Coronavirus (COVID-19) FAQs for Employers
- March 18
- March 17
- March 16
- March 13
- March 12
- March 10
- March 6
- March 5
- February 28