Federal COVID-19 Response Announcements: September 10, 2021

This week, the Biden administration announced a six-point plan to combat COVID-19, with the stated goals of getting more people vaccinated, decreasing hospitalizations and deaths, and keeping schools and the economy open. This plan includes – 

  • Vaccination mandates (government employees, government contractors, Medicare/Medicaid supported facilitates AND private sector business over 100 people)
  • Vaccine booster updates 
  • Efforts to increase test capacity and masking
  • Supporting school vaccinations and testing
  • Small business assistance
  • Increasing access to treatment

What It Is

Vaccination Mandates

Today’s moves trump all of these previous announcements on vaccine and testing requirements to date. 

  • Through two Executive Orders, all government employees and government contractors will be required to be vaccinated. No more testing protocol option. 
    • In 7 days, the Safer Federal Workforce Task Force, established by Executive Order 13991 of January 20, 2021 (Protecting the Federal Workforce and Requiring Mask-Wearing) is charged with releasing guidance on implementation
    • “Employee” means an employee as defined in 5 U.S.C. 2105 
    • “Contractor” is defined in Section 5 of the EO 
  • Through an interim final rule with comment period to be issued in October, all staff in Medicare and Medicaid-certified facilities will be required to have vaccinations. 
    • This will impact “workers in most health care settings that receive Medicare or Medicaid reimbursement, including but not limited to hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies… and will apply to nursing home staff as well as staff in hospitals and other CMS-regulated settings, including clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident, or client care.
    • The administration estimates this will impact 50,000 providers and 17 million workers.
  • Through an upcoming emergency temporary standard, the Department of Labor’s Occupational Safety and Health Administration (OSHA) will require employers with more than 100 employees to include a COVID-19 vaccine mandate or testing requirement. Non-complying companies could be fined up to $14,000. OSHA is also developing a rule to require employers with more than 100 employees to provide paid time off for vaccination and if they feel “under the weather” after vaccination.

The administration notes that combined, these actions will impact 100 million Americans, or about 2/3 of all workers.

Booster Roll Out Update

Last month, in a joint HHS statement and press appearance, the administration announced that it has developed a plan to offer booster shots beginning September 20th for individuals who are at least 8 months out from completing their initial regimen with the Pfizer or Moderna vaccines. That was contingent on the Food and Drug Administration (FDA) and the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) giving the green light. Since that announcement, press has reported pushback from government and other scientists

In its announcement, the Biden administration defended its work on boosters in advance of FDA and CDC action, noting that the nation will be better prepared for a booster roll out when compared to the original vaccination roll out. The report also notes that other common vaccines are three doses (Hep B, HPV), which seems to indicate that the messaging is evolving from a “booster” to 3-dose regimen (which is already how the 3rd dose for immunocompromised patients is understood).

They committed that if and when FDA and CDC move forward with issuing an Emergency Use Authorization (EUA) and recommending a booster vaccine, there will be enough for all Americans and it will be available right away for no out-of-pocket cost (i.e. no waiting for certain groups to go first). The administration has launched Vaccines.gov, as well as a toll-free number, 1-800-232-0233, and text code 438829 to provide information about vaccine availability and locations. 

Efforts to Increase Test Capacity and Masking

The administration has committed to increasing test capacity, with an emphasis of rapid and at-home testing. These actions include:

  • Using the Defense Production Act (DPA) to procure $2 billion worth of at home tests (280 million tests) and incentivize the manufacturing base 
  • Expanding free pharmacy testing to 10,000 more sites
  • Sending 20 million free rapid tests to community health centers and food banks
  • Walmart, Amazon, and Kroger commitments to providing at-home tests at cost (~35% discount)
  • Providing Medicaid coverage for at-home tests

There has been a big uptick in reported issues with unruly passengers on flights over the past few months. The Association of Flight Attendants-CWA, AFL-CIO, has been vocal about the need for more action against these passengers to hold people accountable and deter future bad behavior. Today, the administration announced that fines will double for non-compliance with masking, and the masking order will extend through January 18th, 2022.

Increasing School Vaccinations and Testing

The administration continues to press Governors and school district leaders to mandate vaccinations among staff and eligible students, enforce masking, and deploy testing (remember, the federal government has little jurisdiction over local school districts). The administration has committed to paying any teacher or school administrator who has their paycheck withheld by a state for implementing vaccine or mask mandates. They also announced a vaccination requirement that will come via upcoming rulemaking for all Head Start, Department of Defense (DoD) schools, and Bureau of Indian Education Schools teachers and staff. The administration also commits to giving FDA resources to help review data to support an EUA for vaccines for kids under 12 – a move to toe the line between gentle pressure and political influence.   

Small Business Assistance 

The Small Business Administration (SBA) will increase the maximum amount of funding a small business can borrow through the COVID Economic Injury Disaster Loan (EIDL) program, which provides long-term, low-cost loans, from $500,000 to $2 million. SBA will also make it easier for small businesses with multiple locations in hard-hit sectors like restaurants, hotels, and gyms to access these loans. The administration is also establishing the SBA Community Navigator program, which works with small business to connect them to federal, state, and local resources, and will complete the competitive review process to select Community Navigators this Fall.

The administration also announced a new streamlined process for Paycheck Protection Program (PPP) loan forgiveness for small loans.

Treatment

The DoD will be doubling the number of clinicians deployed to around the country to COVID-19 hot spots. The administration will also be increasing the number doses of monoclonal antibody treatments shipped to health care facilities by 50%. HHS will amend the PREP Act declaration to increase the number of providers who can administer these treatments, including pharmacists.

What It Means for You

If you work in a doctor’s office, hospital, nursing home, or other health care facility, you will likely be subject to a mandate to get vaccinated. Without the regulation text, it’s unclear if there will be exceptions to the mandate, or if testing protocols may be substituted (as is the case for the original federal worker mandate and the OSHA employer mandate), but given the sweeping announcements today, we think exemptions for healthcare workers will be unlikely. 

If you work for a large employer, you will likely to be subject to a mandate to get vaccinated or submit to regular testing.

If you work for a small employer, things may not change that much. However, given these new actions, many businesses that are not subject to the OSHA rule, may choose to impose similar protocols. We have already seen this with vaccine and testing requirements imposed by major U.S. employers over the last several weeks. 

If you are government contractor, check the definitions in Section 5 of the EO to see if your contract is included. 

What’s Next?

RULES!!! 

CMS and OSHA both have work to do to implement their respective mandates. We imagine these are mostly drafted and should pop publicly in the next couple of weeks. The standards and rules will include more details of the mandates and the authorities invoked to implement them. Will someone sue? Probably. 

FDA/CDC spotlight 

  • EUA updates –Remember, only one COVID-19 vaccine has been licensed (aka approved) by the FDA – Pfizer’s for ages 16 and up. After the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on the 17th, will FDA act to issue an EUA for Pfizer’s booster shots, and if so, how long will that take? We are also waiting on licensures for Moderna and J&J, and EUAs for kids (across all manufacturers) and EUAs for other boosters. 
  • ACIP Recommendations – These will come after the various FDA decisions above. If you want a sneak peek at their thinking on boosters, take a look at the slides from last month’s ACIP meeting where they began discussion on the topic.  

Resources

Action Plan Website 

CMS Press Release on Provider Mandates

Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors 

Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees