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 MONDAY, APRIL 6, 2020
The Latest News
- U.S. COVID-19 cases exceed 336,776 and 9,655 U.S. deaths. (Source: CDC)
- U.S. stock market: On Friday the markets ended the week with another loss, with the Dow falling 360 points and S&P 500 down 38 points for the day, with each ending the week down over 2%, and the Nasdaq down almost 115 points for the day and ending the week down 1.7%. Weekend trading in stock futures were pointing to gains as of Sunday night.
- Last Friday, as required by the CARES Act emergency loan program the Small Business Administration began its first day accepting applications and documented 245 lenders received 1,926 loan requests within the first two hours and processed 17,503 small business loans valued at more than $5.4 billion by the end of the day.
- The Centers for Disease Control and Prevention announced on Friday its recommendation that everyone use a simple cloth over one’s face to slow the spread of the virus. The cloth does not need to be a face mask (or N95) and can be fashioned from household items.
- The U.S. Supreme Court has extended the briefing schedule through August 2020 in its review of the U.S. Court of Appeals for the Fifth Circuit’s decision about whether the Affordable Care Act’s individual mandate is unconstitutional (California v. Texas, Case No. 19-840). The Supreme Court also postponed additional oral arguments scheduled for this spring, including cases about an Arkansas law imposing new restrictions on the state’s pharmacy benefit managers and whether employers can be required to provide contraceptive coverage in employee health plans.
- For the third time in a week (4/2/20), President Trump has invoked the Defense Production Act and ordered a ban on exports by 3M Co. of scarce supplies, including N95 respirators, surgical masks, and gloves.
- Earlier last week, the President ordered the Secretaries of the Departments of Health and Human Services and Homeland Security to “help domestic manufactures like General Electric, Hill-Rom, Medtronic, ResMed, Royal Philips, and Vyaire Medical secure the supplies they need to build ventilators needed to defeat the virus.”
COVID-19 Related Legislation
- Bill 4.0: The President and congressional leaders expand discussions regarding what components might be in the of the next emergency response bill.
- The President first raised the possibility of including infrastructure priorities earlier in the week, and House Speaker Nancy Pelosi (D-CA) acknowledged last Thursday that the next bill may include infrastructure spending, including water projects, broadband, and transportation.
- Speaker Pelosi stated over the weekend, “We must double down on the down-payment we made in the CARES Act by passing a CARES 2 package, which will extend and expand this bipartisan legislation… must go further in assisting small businesses including farmers, extending and strengthening unemployment benefits and giving families additional direct payments… resources for our state and local governments, hospitals, community health centers, health systems and health workers, first responders and other providers on the frontlines of this crisis.”
- Bill 3.0: Coronavirus Aid, Relief, and Economic Security (CARES) Act, (R. 748) passed on March 27. The CARES Act is a $2.2 trillion-dollar package includes $500 billion in financial assistance for distressed businesses, $349 billion in low-interest small business loans, and $100 billion in financial assistance for Medicare/Medicaid enrolled healthcare providers and suppliers. The bill also includes $1,200 in financial assistance for the lowest income taxpayers, an additional 13 weeks of unemployment compensation benefits, and an employee extension credit.
- A congressional section by section summary is available here.
- A&B detailed summaries are below:
- A&B Summary – CARES Act Health Provisions
- A&B Overview – CARES Act Health Care Grants and Reimbursement Changes
- A&B Overview – CARES Act Key Health Care Appropriations
- A&B Analysis – CARES Act Funding Sources (Updated 4/5/20):
- $367 billion for Small Business Administration
- Paycheck Protection Loan program (updated per the Interim Final Rule)
- $500 billion for the Treasury’s Business Stabilization Loan Fund
- Tax Credits and Other Potentially Beneficial Tax Considerations
- A&B Summary – CARES Act Small Business Provisions
- A&B Summary – CARES Act Educational Provisions and Appropriations
- A&B Summary – CARES Act Individual and Business Tax Provisions
- A&B Summary – CARES Act Unemployment Provisions
- A&B Summary – CARES Act Labor Provisions
- A&B Guide -- how the CARES Act refundable Employer Retention tax credit for employers works (New)
- A&B Hospital Provisions Tracking Document of COVID-19 Provisions Impacting Hospitals from all three bills (Updated on 4/6/20))
- 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.
- Speaker Pelosi announced the formation of a special bipartisan oversight panel to be called the House Select Committee on the Coronavirus Crisis to be chaired by house Majority Whip Jim Clyburn (D-SC) and will be dedicated to ensuring that the $2 trillion already allocated is “spent wisely and effectively.”
Key Administrative and Regulatory Actions
- President Trump declared (3/13/20) a national emergency under the Stafford Act, which allows the federal government to marshal additional resources and authorize greater regulatory flexibility to respond to the coronavirus outbreak.
Department of Commerce
- Department of Commerce (DOC) Bureau of Industry and Security posted a statement describing the structure of the Defense Priorities and Allocations System (DPAS) and the authority delegated to other agencies. The statement links to a DPAS training Course to assist a company that receives priority rated contracts, subcontracts, or purchase order from the U.S. government or its contractors.
Department of Defense
- The Office of the Under Secretary of Defense released a memo (4/2/20) stating that DoD contracts contain clauses that provide “that a contractor will not be in default because of a failure to perform the contract if the failure arises beyond the control and without the fault or negligence of the contractor.”
- The President announced an executive order (3/30/20) to order up to 1 million Ready Reserve members to active duty for up to two years at a time to assist the nation in this national emergency. He authorized 100% federal cost-sharing for the governors of Connecticut, Illinois, Michigan, Florida, Louisiana, Maryland, Massachusetts, New Jersey, Guam, and Puerto Rico to use National Guard to support state and local emergency assistance for 30 days.
- The Army Corps of Engineers released a draft (3/23/20) request for proposals for companies to submit bids with capabilities to convert hotel space to an acute alternate care facility to support treatment for COVID-19 patients.
Environmental Protection Agency
- On April 3, EPA Administrator Wheeler outlined steps to protect against fraudulent disinfectant claims.
- Last Thursday, the EPA revised List N: Disinfectants for Use Against SARS-CoV-2 to include products on EPA’s List G: Products effective against norovirus, and List L: Products effecting against the Ebola virus, as EPA has determined that these products also meet its criteria for use against SARS-CoV-2. There are now 357 disinfectants on List N. EPA has updated the List to include the specific types of surfaces products can be used on, such as hard or soft surfaces; use sites, such as hospital, institutional or residential; and whether a product can be applied by fogging.
- The EPA will temporarily allow (3/31/20) manufacturers of already-registered EPA disinfectants on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 to obtain certain active ingredients from any supplier without checking with the agency for approval.
- EPA issued an enforcement memo, “COVID-19 Implications for EPA’s Enforcement and Compliance Assurance Program” (3/26/20), detailing the Agency’s plan to exercise enforcement discretion for situations related to COVID-19. The policy is retroactive to March 13.
- EPA will not seek fines and penalties for missed deadlines in routine monitoring, testing, and reporting; settlement agreements; and consent decrees, and for excess emissions, so long as the company documents in detail that it was related to COVID-19 and takes every effort to meet compliance obligations. EPA must be notified of emission exceedances.
- EPA is allowing hazardous generators to store additional waste onsite, for longer periods of time, without requiring a permit or changing generator status.
- For animal feeding operations, the inability to transfer animals off-site will not trigger regulation as a CAFO, or a larger-categorized CAFO.
- EPA may offer “No Action Assurance” to operators of some critical infrastructure facilities, on a case-by-case basis. Public water systems are excluded from this policy.
- EPA also issued a warning to pesticide producers, manufacturers, distributors, and importers who claim their products can be used against COVID-19: ensuring companies comply with all applicable requirements for pesticide products – including prohibitions on false and misleading claims – will be the agency’s “focus” in order to protect public health.
- EPA is allowing manufacturers of disinfectants to obtain certain inert ingredients and inactive ingredients from different suppliers without checking with the agency for approval.
- EPA created a website, Coronavirus and Drinking Water and Wastewater, which states that the risk to water supplies from the COVID-19 virus is low, and “Americans can continue to use and drink water from their tap as usual.”
Federal Communications Commission
- The Federal Communications Commission (FCC) provided relief on April 1 to enable rural broadband and phone providers to immediately waive consumer fees, including late payment and installation and cancellation fees, in order to help Americans work from home or access remote learning.
- The FCC adopted a program for $200 million in COVID-19 telehealth grants (the COVID-19 Telehealth Program) and $100 million in grants through the Connected Care Pilot Program to assist hospitals, and other health care providers cover telehealth costs. The funds for both were authorized by the CARES Act.
- The FCC is now accepting applications for COVID-19 Telehealth Program. The Wireline Competition Bureau will review applications, select participants, make funding awards on a rolling basis, and will announce such information.
- To apply, applications must be submitted through the FCC’s Electronic Comment Filing System (ECFS), inputting “20-89” in the “Proceeding(s)” box and completing the form, including the required information described in the Report and Order. Applicants also must send a courtesy copy of the application via email to EmergencyTelehealthSupport@fcc.gov.
- Applicants can obtain an eligibility determination by filing an FCC Form 460 with the Universal Service Administrative Company (USAC). Applicants can still submit an application for the COVID-19 Telehealth Program while the Form 460 application is pending.
- The FCC also provided additional details on the Connected Care Pilot Program. The selected pilot projects will be supported for a three-year funding period, with separate transition periods of up to six months before and after the funding period (up to four years total).
- Applicants must first obtain a USAC eligibility determination (Form 460, noted above). After confirming eligibility, the applicant must submit its pilot project proposal to the FCC.
- The FCC plans to provide an application form (“Connected Care Pilot Program Application”) that must be used when submitting project proposals to the FCC. Submitted applications must reference WC Docket No. 18-213. Applicants may file using the ECFS, but also must send a courtesy copy of the application via email to ConnCarePltProg@fcc.gov.
- The deadline for filing applications will be 45 days from the effective date of the Connected Care Pilot Program rules or 120 days from the release date of the Report and Order (whichever is later).
- Additional details on the application and evaluation process, including key information on eligibility, certain required certifications, and how the FCC will choose participants, are available in the Report and Order.
Department of Health and Human Services
- On March 25, pursuant to the President’s Executive Order, the Department of Health and Human Services (HHS) announced its initial list of health and medical resources that are subject to hoarding prevention measures. The list is subject to review and potential additions later. It includes several varieties of facial masks and other protective equipment, respirators, ventilators, drugs, and disinfectants.
- HHS has unveiled a new COVID-19 Resources page.
- The HHS Office of Civil Rights announced that it will exercise its enforcement discretion and will not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against health care providers or their business associates for the good faith uses and disclosures of protected health information (PHI) by business associates for the public health and health oversight activities during the COVID-19 nationwide public health emergency. This notice is effective immediately.
- HHS announced (3/24/20) $250 million in grants for meal programs for older adults. The program is administered through the Administration of Community Living (ACL), and funding was provided through the FFCRA legislation passed in March.
Assistant Secretary for Preparedness and Response
- ASPR announced (3/24/20) it was providing $100 million in awards for health systems to prepare for COVID-19 patients.
Centers for Disease Control and Prevention
- For the most up to date CDC guidance visit here.
- The CDC updated its recommendations (4/3/20) on optimizing the supply of PPE.
- The CDC also released guidance on the collection and submission of postmortem specimens from deceased person with COVID-19, and last week multiple new areas of information was posted on: health care providers and pregnant women; pediatric providers and children; what law enforcement need to know; what school administrators need to know; and PPE for individuals caring for a COVID-19 patients.
- On March 25, the CDC published two preparedness checklists: one for health care professionals and one for hospitals.
- The CDC released guidance (updated 3/24/20) on COVID-19 testing priorities. Priority 1 is limited to hospitalized patients and symptomatic workers. Priority 2 is limited to symptomatic persons who live in nursing facilities, are 65 or older, have underlying medical conditions, or are first responders.
- The CDC also updated its infection control
- The CDC’s FAQs (3/22/20) for health professionals.
Centers for Medicare & Medicaid Services
- CMS has created a website location for COVID-19 stakeholder call recordings and transcripts, and daily CMS COVID-19 news alerts can be found here.
- Late Thursday, CMS issued recommendations to nursing homes and state and local governments on infection control in long term care. The recommendations include:
- Nursing homes should immediately ensure that they are complying with all CMS and CDC guidance related to infection control.
- CMS/CDC urges State and local leaders to consider the needs of long-term care facilities with respect to supplies of PPE and COVID-19 tests.
- Nursing homes should immediately implement symptom screening for all staff, residents, and visitors – including temperature checks.
- Nursing homes should ensure staff are using appropriate PPE, to the extent PPE is available and per CDC guidance on conservation of PPE.
- CMS announced on Monday (3/30/20) that it will suspend audit activity, stating that, “The agency will continue to engage in oversight activities but will suspend requesting additional information from providers, healthcare facilities, Medicare Advantage and Part D prescription drug plans, and States.”
- On March 30, CMS released an Interim Final Rule, which made numerous regulatory changes to provide additional flexibility for health care providers and temporarily remove certain limitations on care delivery. These changes have retroactive applicability to March 1. While many of these changes were developed prior to the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), significant flexibility has been conferred during the COVID-19 public health emergency, including:
- Expanded use of telehealth; Removing the face-to-face or in-person requirements where required by NCDs and LCDs;
- Changes intended to increase hospital capacity (e.g., allowing hospitals to provide services in other sites of care);
- Additional flexibility to expand the health care workforce, including relaxing teaching physician presence requirements and providing liability protection for health care volunteers;
- Amending the calculations for Medicare Advantage and Part D star ratings; and
- Providing relief for participants in certain CMS demonstration programs, the Quality Payment Program, and the Medicare Shared Savings Program.
CMS CARES Act Guidance
- In response to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), CMS continues to release guidance required under the Act:
- On March 30, CMS announced sweeping changes in response to requirements of the CARES Act. The changes are summarized in this CMS release. The new waivers and flexibilities for health care providers are outlined by CMS in the following:
CMS new waivers and flexibilities:
Provider-specific fact sheets on new waivers and flexibilities:
- Physicians and Other Practitioners (PDF)
- Ambulances (PDF)
- Hospitals (PDF)
- Teaching Hospitals, Teaching Physicians and Medical Residents (PDF)
- Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities) (PDF)
- Home Health Agencies (PDF)
- Hospices (PDF)
- Inpatient Rehabilitation Facilities (PDF)
- Long Term Care Hospitals & Extended Neoplastic Disease Care Hospitals (PDF)
- Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (PDF)
- Laboratories (PDF)
- End Stage Renal Disease (ESRD) Facilities (PDF)
- Durable Medical Equipment (PDF)
- Participants in the Medicare Diabetes Prevention Program (PDF)
- Medicare Advantage and Part D Plans (PDF)
- Need a deeper dive on these new waivers?
- The EMTALA waiver provides greater flexibility for hospitals to manage medical screening examinations (MSEs). For additional analysis, read this A&B advisory (4/1).
- CMS also announced blanket waivers of sanctions imposed under the physician self-referral laws. For a detailed discussion of this issue, read this A&B advisory (4/1)
- The telehealth expansion waiver, which was originally expanded in the Coronavirus Preparedness and Response Supplemental Act (1.0), was further expanded in the CARES
- CMS released an information bulletin (4/2/20) on telehealth for Medicaid substance use disorder services.
- The full details of the latest telehealth changes are discussed in this A&B advisory (3/31/20).
- Telehealth guidance (3/17/20) was announced last week broadening access to Medicare telehealth service regardless of patient residence and covering a wide range of services. The telehealth waiver has been expanded; states can cover telehealth without approval, and HIPAA rules will be relaxed, and penalties waived. Factsheets related to these changes:
- CMS issued an electronic toolkit regarding telehealth and telemedicine for Long Term Care Nursing Home Facilities (3/28/20)
- CMS telehealth FAQs (3/17/20)
- HHS 1135 HIPAA waiver factsheet - HIPAA Security Rule safeguards
- HHS Notice of Enforcement Discretion factsheet
- HHS Office of Civil Rights bulletin
- Guidance on Business Associate Agreements
- The CARES Act required CMS to expand its accelerated and advance payment program, and on March 28 a statement and fact sheet were released providing guidance on the policy. For additional analysis, read this A&B advisory (3/30/20) on the CMS guidance.
- CMS, on behalf of Vice President Mike Pence, sent a letter (3/30/20) to the nation’s hospitals requesting (not requiring) they report data, including on testing, bed capacity, and supplies connection with their efforts to fight the COVID-19 pandemic.
- The CMS Center for Clinical Standards and Quality (CCSQ) issued a memorandum (3/26/20) stating that under the Clinical Laboratory Improvement Act (CLIA) the agency would allow laboratories to utilize temporary testing sites, such as the pathologist’s home, for remote review and reporting of slides/images as long as specific criteria are met.
- On 1135 Waivers: Further information continues to be released on blanket waivers after the initial guidance (3/13/20) response to the national emergency executive order.
- CMS issued provider enrollment FAQs for 1135 blanket waiver, available here (3/22/20).
- In addition, there is an FAQ on telehealth services (Q11) and requirements if a practitioner seeks to furnish Medicare telehealth services from his or her home.
- CMS has approved 42 states for coronavirus 1135 waivers, and for more details and the full list CMS approved 1135 waivers can be found here. And on March 27, CMS announced the approval of 16 state hospital associations in one letter (it can be found here and additional information.)
- The National Uniform Billing Committee has provided guidance on claims for COVID-19 treatment and approved the use of DR (disaster related) condition code for services related to the coronavirus.
- On March 25, CMS announced it did not have the authority to waive Open Payment reporting requirements, and the March 31 deadline remains in place.
- CMS released several other alerts and guidance the week of March 23:
- Medicare Provider Enrollment Relief FAQs (see: FAQs).
- CMS posted guidance on Payment and Grace Period Flexibilities for issuers offering coverage on the federally-facilitated exchanges and state-based exchanges on the federal platform (see: guidance).
- CMS announced it will be exercising enforcement discretion so QHP issuers and SADPs can extend payment deadlines for initial binder payments and ongoing premium payments. CMS released FAQs on availability and usage of telehealth through private health insurance (see: FAQs).
- CMS released FAQs on prescription drugs and COVID-19 for health insurance issuers in individual and small group markets (see: FAQs).
- CMS announced (3/22/20) relief for providers participating in quality reporting programs, including granting exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs for the upcoming measure and data submission for those programs. The release includes tables listing the impacted programs and extensions.
- On April 2, CMS updated their Medicaid FAQs.
- CMS posted notice (3/24/20) that it had withdrawn its proposed rule to tighten Medicaid eligibility
- CMS released guidance (3/24/20) implementing provisions of the FFCRA that provide states with enhanced federal Medicaid funding referred to as the Federal Medical Assistance Percentage (FMAP) funding during the COVID-19 emergency.
- CMS released new tools (3/20/20) for state Medicaid and Children’s Health Insurance Programs (CHIP) and updated FAQs (3/18/20). The tools include:
- 1115 Waiver Opportunity and Application checklist;
- 1135 Medicaid and CHIP Waiver checklist;
- 1915(c) Appendix K template; and
- Medicaid Disaster State Plan Amendment template.
- CMS announced (3/23/20) it will limit its nursing home inspection protocol to focus more specifically on complaint and infection control inspections.
- CMS released guidance (3/17/20) to Program of All-Inclusive Care for the Elderly (PACE) Organizations.
- Health care providers with exposure to COVID-19 raises numerous serious questions and to better understand these considerations for health care workers and their employees, read this A&B advisory (3/24/20).
Food and Drug Administration
- FDA provides a daily roundup on COVID-19 related April 3 actions
- The agency published a public database of drug shortages.
- Last Friday, the FDA announced it will temporarily conduct remote importer inspections under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP).
- FDA has provided updated guidance to address the need for blood donations during the coronavirus crisis, including immediate changes to the eligibility criteria.
- FDA continues to issue emergency use authorizations for ventilators, PPE, diagnostic tests, and on April 1, the first COVID-19 test that looks for antibodies in the blood was authorized for treatment of COVID-19.
- For a deeper dive on FDA accelerated approval process for COVID-19 tests, see this advisory.
- In a press release on Tuesday, FDA announced the Coronavirus Treatment Acceleration Program (CTAP), a new program to expedite the development of potentially safe and effective life-saving treatments.
- On April 1, FDA released a temporarily enforcement discretion policy to provide flexibility to chain restaurants and similar retail food establishment subject to FDA’s menu labeling requirements. Under its policy, FDA will not object if covered establishments do not comply with menu labeling requirements until “conclusion of the public health emergency.”
- FDA has issued enforcement policies to increase the availability of ventilators and accessories, face masks and respirators, gowns, other apparel and gloves, and sterilizers, disinfectants and air purifiers.
- The FDA updated its FAQs (4/2/20) on surgical masks and gown shortages.
- An A&B analysis of the agency’s FAQs regarding the growing shortages of personal protective equipment is available here.
- FDA has provided strategies to assist in the conservation of masks and gowns, as well as glove conservation strategies.
- FDA issued guidance on notifying FDA of permanent discontinuation or interruption in manufacturing.
- The CARES Act includes OTC drug reform that would create an OTC drug user fee system, ensure FDA can approve OTC medicines without going through a full notice and comment rulemaking and allow for 18-month exclusivity for certain OTC drugs.
- In the midst of ongoing food safety concerns, DHS has included the food and agriculture sector as “essential critical infrastructure,” and a full analysis of these issues is available here.
- Both USDA FSIS and FDA have issued enforcement discretion policies to provide labeling flexibilities for products intended for food service going to retail.
- FDA has announced a temporary policy to not enforce Foreign Supplier Verification Program (FSVP) onsite audit requirements under specific circumstances, and both FDA and USDA have also been issuing guidance to industry that addresses food safety concerns. DHS has included the food and agriculture sector as “essential critical infrastructure,” and a full analysis of these issues is available here.
- FDA previously issued, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” to assist sponsors in assuring the continued safety of trial participants, while minimizing risks to trial integrity, and maintaining compliance with good clinical practices (GCPs) during the pandemic. Included in the new guidance are the options for phone contact and virtual visits in clinical trials.
Health Resources and Services Administration
- HRSA updated its FAQs (4/2/20) for health centers with additional questions to address the Federal Tort Claims Act among other flexibilities that have been enacted.
- HRSA awards (3/24/20) $100 million to 1,381 health centers across the country with funding provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The awards, by state, is available here.
- HRSA released guidance (3/27/20) noting the COVID-19 public health emergency warranted additional flexibilities regarding 340B covered entities, including allowing self-reporting of patient identity, condition, and history for purposes of 340B recordkeeping requirements.
- HRSA released waiver (3/25/20) of the Paperwork Reduction Act.
Department of Homeland Security/FEMA
- The Department of Homeland Security (DHS) and Department of Justice announced on Wednesday that they have extended the temporary postponement of Migrant Protection Protocols (MPP) hearings scheduled through May 1, 2020.
- DHS announced (3/26/20) that the deadline to enforce REAL ID requirements would be delayed 12 months to October 1, 2021.
- The Cybersecurity and Infrastructure Agency (CISA) released updated guidance (3/28/20) on essential critical infrastructure workers.
- Federal Emergency Management Agency’s (FEMA) coronavirus website visit here.
- FEMA Supply Chain Task Force has developed a four-pronged approach to securing needed coronavirus supplies. The four prongs are Preservation, Allocation, Acceleration, and Expansion. The details on the March 30 plan can be found here. In a related move, the FEMA Coronavirus Pandemic Supply Chain Stabilization Task Force (a joint FEMA and HHS initiative) has released a fact sheet.
- FEMA has established How to Help website for individuals and organizations interested in helping the effort to combat the spread of COVID-19. Examples of assistance offered include:
- To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011).
- This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at sam.gov. Registration must be “ACTIVE” at the time of award.
- If you have medical supplies or equipment to donate, please provide us details on what you are offering.
- If you are a private company that wants to produce a product related to the COVID-19 response – email firstname.lastname@example.org.
- If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.
- If you are interested in doing business with FEMA and supporting the response to COVID- 19 with your company’s non-medical goods and/or services, please submit your inquiry to the Department of Homeland Security (DHS) Procurement Action Innovative Response Team (PAIR) team at DHSIndustryLiaison@hq.dhs.gov.
- FEMA provides guidance (updated regularly) to companies seeking to import or manufacture medical products to the COVID-19 response. A list of FEMA regional private sector contacts and state contacts can be found here.
Department of Justice/Federal Trade Commission
- On April 1, the Department of Justice (DOJ) announced that it is making $850 million available to help public safety agencies respond to the coronavirus pandemic.
- On March 23, President Donald Trump released an Executive Order on hoarding and price gouging of critical COVID-19 supplies. For guidance and tips on how businesses can respond if they are victims of price gouging, read this A&B advisory (3/26/20).
- On April 2, the FTC and FDA sent letters to three companies for selling fraudulent COVID-19 products, as part of the agencies’ effort to protect consumers. (Letters available here, here, and here). This is the third time the FTC sent warning letters to companies for their actions related to the pandemic.
- On March 27, the FTC sent letters to nine VoIP providers and other companies warning them that “assisting and facilitating” illegal telemarketing or robocalls related to the Coronavirus pandemic, including by providing VoIP services, is against the law. Earlier in March, the FTC and FDA sent warning letters to seven companies about unsupported claims that products can treat or prevent Coronavirus.
- The FTC Chairman Joe Simons issued a statement (3/26/20) outlining the agency’s efforts to protect consumers during the Coronavirus pandemic. Simons also acknowledged the challenges businesses face in getting important goods and services to people across the country, and that the agency would be “flexible and reasonable” in enforcing compliance requirements. He also announced an email address for businesses seeking guidance: email@example.com, noting FTC staff would respond to inquiries as quickly as possible.
- On March 25, the FTC released business guidance warning against various scams seeking to exploit companies’ concerns around COVID-19. Scams the FTC warns against include a variety of robocall and email-related phishing scams (including through emails purporting to come from company CEOs or IT departments, or government agencies), and fraudulent websites that mimic legitimate online retailers. The alert also provides advice on how companies can keep their networks safe.
- DOJ Antitrust Division and Federal Trade Commission (FTC) announced (3/24/20) they will be expediting their usual antitrust business review letter/informal opinion process on competitor collaborations to be done within 7 days (as opposed to the usual many months) of submission of information. It will be available to entities proposing to collaborate on public health projects responding to the virus, including health care providers and other suppliers of relevant goods and services.
- Coronavirus challenges grow for companies responding to issues like the new expedited government review process. For practical advice on avoiding antitrust risk, review this A&B advisory. (3/24/20)
- The DOJ completed its first Business Review Letter under the new expedited review process on April 4, announcing that “it will not challenge collaborative efforts of McKesson Corporation, Owens & Minor Inc., Cardinal Health Inc., Medline Industries Inc., and Henry Schein Inc. to expedite and increase manufacturing, sourcing, and distribution of personal-protective equipment (PPE) and coronavirus-treatment-related medication.”
- In addition to the expedited BRL process, certain joint ventures and standard development organizations can also find some level of reduced antitrust risk through a seldomly used law—the National Cooperative Research and Production Act (“the NCRPA”).
- The DOJ filed its first enforcement action (3/21/20) against COVID-19 fraud, successfully obtaining a temporary restraining order against the operators of the website, “coronavirusmedicalkit.com.”
- Understanding how federal agencies will review merger transactions during the coronavirus outbreak has business and legal implications. The A&B Mergers & Acquisitions Group examines (3/19/20) what you need to know.
Department of Labor
- The Department of Labor (DOL) provided FAQs further clarifying paid leave requirements under the new Families First Coronavirus Response Act (FFCRA).
- On Sunday, published guidance to states for the implementation of the Pandemic Unemployment Assistance (PUA) program. Under PUA, individuals who do not qualify for regulator unemployment compensation and are unable to continue working as a result of COVID-19, are eligible for up to 36 weeks of PUA benefits.
- Last Friday, DOL released additional guidance which includes a comprehensive webinar explaining which employers are covered by the new law, which workers are eligible, and what benefits and protections the law provides. The Wage and Hour Division (WHD) also added additional Questions and Answers to its website in response to the questions most frequently received to-date through its extensive stakeholder engagement. Workplace posters translated into additional languages, which fulfill notice requirements for employers obligated to inform employees about their rights under the FFCRA, have also been added to WHD’s website. To view the webinar and other guidance materials, visit here.
- A&B’s Labor and Employment Group provides an overview of the FFCRA and an updated collection of responses to some of the most common questions about employer obligations in this advisory (3/31/20).
- The DOL posted (3/26/20) the required employee notice that must be provided by covered employers to their employees regarding the new paid leave requirements as required by the FFCRA. The posted page contains the link to the poster itself, as well as a new Q&A that focuses exclusively on guidance about posting the notice, particularly in light of the fact that many employees are working remotely. Covered employers should make sure they get this notice posted appropriately no later than the April 1 effective date of the new leave requirements.
- DOL released its first round of guidance (3/24/20) with fact sheets for employers and employees.
- DOL released a statement (3/9/20) which includes an overview of key COVID-19 related DOL and Occupational Safety and Health Administration (OSHA) documents which includes:
- OSHA’s practical guidance (3/21/20) to prevent the spread of COVID-19
- OSHA’s COVID-19 website (3/20/20)
- Wage and Hour Division (WHD) guidance (3/24/20)on Families First Coronavirus Response Act (FFCRA): Employee Paid Leave Rights
- WHD guidance (3/24/20) on FFCRA: Employer Paid Leave Requirements
- WHD FAQs (3/24/20) on COVID-19 and the Fair Labor Standards Act
- WHD FAQs (3/24/20) on COVID-19 and the Family and Medical Leave Act
- Trying to make sense of all these changes? A&B provides brief overviews of what you need to know:
- DOL has released additional questions and answers as guidance for the provisions required by FFCRA. A&B provides a complete overview and analysis (3/31/20).
- DOL/OSHA updated its website, clarifying that no special precautions (beyond existing requirements) are required for municipal solid waste and recycling suspected or known to contain or be contaminated with COVID-19.
- Large employers are assessing policies and potential liability to ensure a safe and secure workplace. The CDC has released (updated 3/21/20) guidance for employers related to employee information on COVID-19.
Securities and Exchange Commission
- The Securities and Exchange Commission Chairman confirmed in a statement that the June 30, 2020 compliance date for the Regulation Best Interest (Reg BI) and Form CRS remains in effect. The A&B Financial Services & Products Group analyzes compliance with Reg BI and Form CRS mandates in this A&B advisory (4/2/20).
- The SEC issued an amended order (3/25/20) extending the relief available to some companies that cannot timely file their reports due to concerns, including the need to update risk disclosures in response to business threats.
- The A&B Securities Group examines (3/27/20) the SEC’s continued efforts to provide relief to filers whose filing obligations have been affected by the pandemic.
- The SEC issued Disclosure Guidance Topic No. 9 (3/25/20) on the SEC’s current views regarding disclosure and other securities law obligations that companies should consider with respect to COVID-19 and related business and market disruptions.
- The SEC expects filers to disclose the known, likely to be known, and unknown risks they face during the coronavirus pandemic and to better prepare, read these A&B questions to ask yourself (3/30/20).
- The SEC also issued a statement (3/24/20) regarding the authentication document retention requirements under the SEC rules in light of health, transportation, and other logistical issues raised by the spread of COVID-19.
- Companies will need to vigilantly monitor insider trading despite the SEC’s statements on relaxed disclosure and other regulations. These issues are examined in this A&B advisory (3/26/20).
Small Business Administration
- Small Business Administration (SBA) – In response to the CARES Act requirements, the SBA formally launched its Paycheck Protection Program for small businesses on April 3.
- The SBA has guidance (4/1/20) for loans under the Paycheck Protection Program, the Express Bridge Loan Pilot Program, the Economic Injury Disaster Loan Program for qualified entities that are impacted by COVID-19 - the application for its economic injury federal disaster loans can be found here.
- On April 2, the SBA released the interim final rule implementing the Paycheck Protection Program.
- The Paycheck Protection Program authorizes up to $349 billion toward job retention and certain other expenses for small businesses and eligible nonprofit organizations, Veterans organizations, and Tribal businesses described in the Small Business Act, as well as individuals who are self-employed or are independent contractors, are eligible if they also meet program size standards.
- Complete details on the SBA CARES Act programs (Updated 4/4/20):
- For a top-line overview of the program CLICK HERE
- If you’re a lender, more information can be found HERE
- If you’re a borrower, more information can be found HERE
- PPP Borrower Application Form (Updated 4/2/20)
- PPP Lender Application Form
- PPP New Lender Application Form (Federally Insured Depository Institutions, Federally Insured Credit Unions, Farm Credit System Institutions)
- Paycheck Protection Program – Interim Final Rule
- Paycheck Protection Program – Interim Final Rule on Affiliation
- Paycheck Protection Program – Applicable Affiliation Rules
- Find an eligible lender
- Frequently Asked Questions
- For a deeper dive on the funding streams available for SBA loans in the CARES Act, review this A&B publication (4/1/20).
- Businesses large and small are navigating the chaotic economic climate; find some important actions you can take now to better prepare here (3/30/20), and for additional insights on lending and regulatory concerns, read this A&B advisory. (3/30/20)
Department of Treasury
- The Department of Treasury website for CARES Act
- Last Thursday, Treasury Secretary Steven Mnuchin and Small Business Administration Administrator Jovita Carranza announced that the interest rate on what lenders could charge small businesses for loans in the Paycheck Protection Program would be raised from 0.5% to 1%.
- The FFCRA gives businesses with fewer than 500 employees funds to provide employees with paid sick leave and family and medical leave related to COVID-19. On April 1, the Department of Treasury and IRS released FAQs regarding the tax credits available under this Act.
- On April 1, the Treasury Department and the IRS launched the Employee Retention Credit, designed to encourage businesses to keep employees on their payroll. Eligible employers that have been financially impacted by COVID-19 can receive 50% of up to $10,000 in wages paid.
- The CARES Act establishes a $349 billion Paycheck Protection Program and on Tuesday the Department of Treasury jointly with the Small Business Administration announced the details. A brief overview and separate fact sheets for the lenders and the borrower can be found here.
- On Monday, the Treasury Department provided the details on the Economic Impact Payments program up to $1,200 for individuals or $2,400 for married couples. Parents also receive $500 for each qualifying child. This program was also required by the CARES Act.
- On Wednesday, the Department of Treasury and the IRS announced that Social Security beneficiaries who are not typically required to file tax returns will not need to file an abbreviated tax return to receive an Economic Impact Payment. Instead, payments will automatically be deposited into their bank accounts.
- The Treasury Department announced (3/31/20) it was delaying tax payment due dates for wine, beer, distilled spirits, tobacco products, firearms, and ammunition excise taxes, to provide flexibility for businesses that have been negatively affected by COVID-19. The postponement of due dates applies to any tax payment with an original due date falling on or after March 1, 2020, through July 1, 2020.
- The Federal Reserve committed (3/23/20) to using its full range of tools to support households, businesses, and the U.S. economy overall in this challenging time.
- Government required stay-at-home orders have forced people to give significant focus on the use of electronic signatures and the maintenance of electronic records. This A&B advisory (3/27/20) reviews the three main laws that govern electronic signatures.
- In a joint statement (3/22/20), the federal financial institution regulatory agencies and state banking regulators encouraged financial institutions to work constructively with borrowers affected by COVID-19 and provided additional information regarding loan modifications.
- To understand the federal regulators guidance on loan modifications and reporting, see this A&B advisory. (3/24/20)
- Internal Revenue Service (IRS) granted further COVID-19 emergency relief in Notice 2020-18 (superseding its prior announcement) delaying the due date for filing Federal income tax returns and making Federal income tax payments from April 15, 2020 to July 15, 2020. The deadline is automatically postponed with no need for taxpayers to file Forms 4868 or 7004. Unlike prior guidance, there is no limitation on the amount of tax payments that may be deferred until July 15, 2020. Read here for both guidance and FAQs.
- The CARES Act provides a refundable tax credit for businesses of all seizes that experience economic hardship due to COVID-19. Click here for A&B’s guide to how the credit works.
- The IRS has issued the following tax season guidance:
- Coronavirus Tax Relief. (3/13/20)
- IRS Operations During COVID-19: Functions continue guidance. (3/24/20)
- Filing and payment deadlines FAQs. (3/13/20)
- The Department of Housing and Urban Development (HUD) announced (4/1/20) set of mortgage payment relief options for single family homeowners with FHA-insured mortgages who are experiencing financial hardship as a result of the coronavirus pandemic. Mortgage servicers are instructed to:
- Offer forbearance—deferred or reduced mortgage payment options—for up to six months to affected borrowers;
- Delay submitting Due and Payable requests for Home Equity Conversion Mortgages by six months; and
- Extend any flexibility they may have under the Fair Credit Reporting Act relative to negative credit reporting actions.
- The Department of Transportation’s (DOT) Federal Transit Administration issued an Enforcement Notice on Friday clarifying airline refund requirements.
- The DOT announced (4/2/20) $25 billion in federal grant funding to help the nation’s public transportation systems under the CARES Act.
- The Department of Education (DOE) released a proposed regulation on Thursday (4/2/20) amending eligibility requirements for faculty and student interactions in online college programs. Members of the public will have 30 days to submit comments on the Education Department’s proposal before it issues a final rule.
- The Department of Education also announced new federal deadline flexibility for Career and Technical Education leaders on Wednesday.
- On March 31, the S. Patent and Trademark Office (USPTO) announced extensions to the time allowed to file certain patent-related and trademark-related documents and to pay certain required fees. For additional details on this topic, review this A&B advisory (4/2/20).
- The Department of Veterans Affairs (VA) announced on April 3 that financial relief actions would be extended to veterans with COVID-19, include suspending all actions on Veteran debts under the jurisdiction of the Treasury Department and suspending collection action or extending repayment terms on preexisting VA debts, as the Veteran prefers.
- The VA released a statement (3/31/20) that veterans continue to receive benefits and services after the Veterans Benefits Administration (VBA) temporarily closed its 56 regional offices to the public in response to COVID-19.
- The Department of Agriculture (USDA) Rural Development Division has launched a resource page to help rural residents, farmers, and businesses stay current on the Agency actions related to COVID-19.
- On Friday, the Rural Development Division announced it was opening a second application window for the Distance Learning and Telemedicine Grant program funding.
- The Commodity Futures Trading Commission (CFTC) issued a no-action letter (3/20/20) offering temporary relief to commodity pool operators (CPOs) from certain obligations under the Commodity Exchange Act and CFTC regulations. A deeper dive on whether this guidance to allow commodity pool operators to delay their reporting obligations during the coronavirus pandemic can be found here. (3/23/20)
- Construction Industry: The coronavirus pandemic creates special problems for the construction industry which include site safety and contractor and subcontractor responsibilities for such. These issues and more are examined in this A&B advisory.
- Construction contracts: The availability of force majeure and other related doctrines to excuse contractual performance is examined here (3/23/20).
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
- The WTO has released a report on trade in medical products critical for the global response to the COVID-19 Imports and exports of medical products totaled about $2 trillion, approximately 5% of total world merchandise trade in 2019. Trade of critical products and in severe shortage in COVID-19 crisis totaled about $597 billion, or 1.7% of total world trade in 2019. Tariffs on some medical products remain ‘very high’.
- S. Uses Defense Production Act for the Purchase of Ventilators and Respirators. President Donald Trump invoked the wartime Defense Production Act (“DPA”) twice on April 2 (i) to bolster private manufacturers' ventilator production, (ii) and requiring 3M Co. to supply N95 respirators, recognizing the threat that COVID-19 poses to U.S. health care systems.
- S. CBP cargo operations. CBP Local Port Downtime for the Port of Anchorage, Alaska (Port Code 3126) – Effective on 04/02/2020 to Until Further Notice. Due to an employee testing positive for COVID-19, the Port of Anchorage, Alaska will be closed for at least the remainder of this week. At this time, CBP is unsure of the duration of the closure, possibly 14 days. See CSMS message here.
- Coronavirus Affecting Air, Sea and Warehousing Services. About 35% of air cargo capacity worldwide has disappeared with the sharp drop in international passenger flights, according to UPS VP for supply chain operations, in a webinar on April 3 on how the COVID-19 pandemic response is affecting cargo shipments. “Demand has significantly exceeded available capacity, especially on the trans-Pacific trade lane,” said Vito Losurdo, VP of procurement, referring to the Federal Emergency Management Agency’s “air bridge” effort to rush PPE to the New York region.
- The European Commission has adopted a Temporary Framework that allows Member States to grant subsidies to firms with key business sectors at the forefront of these measures. To understand the implications of these actions read this A&B advisory.
- G20 trade leaders commit to WTO-consistent measures in response to COVID-19. Trade ministers from G20 countries on Monday, March 30 said any “emergency measures” to address the coronavirus pandemic must be temporary and consistent with World Trade Organization rules. In a March 30 joint statement following a virtual meeting, trade officials pledged to “take immediate necessary measures to facilitate trade” in medical supplies and equipment as well as critical agriculture products.
- A The Blue Cross and Blue Shield Association and its independent affiliates released a statement last Thursday that they would waive cost-sharing for the treatment of COVID-19 (including testing and treatment administered) through May 31.
- A Pandemic Risk Insurance Act, modeled after the TRIA, has been under consideration by the US House Financial Services Committee since Mid-March. Thus far, a draft bill is unavailable.
- On March 31 bills were proposed in both the Louisiana House and Senate purporting to require insurers to provide business interruption coverage for losses relating to the COVID-19 pandemic. While the House bill tracks the New York, New Jersey and Ohio proposals, the Louisiana Senate proposal would be more expansive—it places no employee-number limitations on the insureds to which it would apply. This even exceeds the Massachusetts proposal, which would apply to insureds with fewer than 150 employees. Neither the Louisiana House nor the Senate proposal expressly purports override policy exclusions for infectious diseases or virus contamination, though it is likely that all of the proposed bills thus far are intended to achieve that result.
- On March 25, Washington joined other state lawmakers, including those in California and New York, in requiring insurers to: (1) submit data regarding the volume of business interruption coverage, contingent business interruption coverage, and supply chain coverage written by the insurer that was in effect as of March 15, 2020; (2) explain the coverage each policy provides relating to COVID-19; and (3) provide an explanation of benefits to policyholders and the Commissioner’s office. Responses are due on or before April 1, 2020.
- New York City and New Orleans have both issued civil authority shutdown orders that explicitly provide that COVID-19 may spread from “surface to person . . . causing property loss and damage in certain circumstances.” These provisions appear calculated to provide future litigants with a plausible hook to argue for business interruption coverage where such coverage is contingent on the existence of “physical damage.”
- The West Virginia Insurance Commissioner published a bulletin on March 26, 2020 explaining that though business interruption policies are governed by contract law that may vary state-by state, they “were generally not designed or priced to provide coverage against communicable diseases, such as COVID-19, and therefore usually include exclusion for that risk.” The Commissioner directs insureds and policyholders to contract their insurer regarding availability of coverage, and explicitly prohibits insurers from reporting “negative claims activity or a claim denial when an insured or policyholder contacts the company or its agent or broker to inquire about business interruption coverage for COVID-19 under its policy.”
- Two additional lawsuits have been filed against insurers challenging denials of claims filed for business interruption coverage in connection with the COVID-19 pandemic. These suits follow several other actions filed in South Carolina, Louisiana, Oklahoma, California and Illinois seeking declaratory judgment regarding the availability of business interruption and civil authority coverage in the wake of COVID-19.
- On March 31, 2020, Billy Goat Tavern filed a Complaint in the Northern District of Illinois against its insurer Society Insurance. The lawsuit mirrors others filed across the country claiming wrongful denial of business interruption coverage for COVID-19 related losses, except that it includes class allegations and seeks to recover for breach of contract and declaratory relief on behalf of both Billy Goat Tavern and “all other similarly situated Illinois businesses that offer food or beverages for on-premises consumption.”
- On April 2, 2020, Sean Boutros, M.D. filed a lawsuit against Sentinel Insurance Co d/b/a The Hartford in Texas seeking declaratory judgment as to whether The Hartford has a duty to indemnify Plaintiff for business interruption losses related to the COVID-19 pandemic.
Additional Workplace (Stay-at-Home) Issues
- Government Closure/Stay-at-Home orders have been released in multiple state and local jurisdictions. To date, states issuing these orders include Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, and Vermont.
- For the key Stay-at-Home order details in one document, view this A&B COVID-19 50-State Closure Tracker (Updated 4/5/20).
- For Government required stay-at-home orders have forced people to give significant focus on the use of electronic signatures and the maintenance of electronic records. This A&B advisory (3/27/20) reviews the three main laws that govern electronic signatures.
- For those asking how to define “federal crucial infrastructure sectors” the Department of Homeland Security’s Cyber Infrastructures division outlines (last update 3/28/20) 16 sectors and provides additional guidance for businesses.
Cyber Security & Privacy
- Government contractors and Federal employeesare part of the newly remote workforce. The Department of Defense has issued new guidance (4/2/20) for its workers.
- The COVID-19 pandemic provides an opening for a variety of malicious cyber-attacks. The FBI details threats and ways to protect yourself (4/1/20)
- Go Video teleconferencing is the new normal for the remote workforce. But is it secure? The FBI offers tips (3/30/20) on how to protect yourself from being hijacked.
- Governments are increasingly seeking to leverage consumer geolocation data collected by industry as a tool to assist with fighting the spread of COVID-19. To see how the U.S. compares with the rest of the world, read this post on our Privacy and Security Blog (3/23/20).
- The Cybersecurity and Infrastructure Security Agency (CISA) released guidance (3/19/20) to help state and local jurisdictions and the private sector identify and manage their essential workforce while responding to COVID-19.
- The World Health Organization (WHO) provides daily “situation” reports.
- The Joint Commission on Accreditation for Healthcare Organizations (The Joint Commission) announced (3/17/20) it was suspending surveying in response to the coronavirus outbreak. The suspension is expected to last through April. For additional information and additional resources visit the joint Commission Coronavirus website.
- The Joint Commission released a statement for healthcare workers regarding the use of face masks brought from home.
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 Families and Households:
Information for Schools and Childcare Providers:
Information for Community Events and Gatherings:
Information for Military Response:
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