OSHA Moving Closer to Publishing Vaccination Mandate Rule

The Occupational Safety and Health Administration’s acting administrator, Jim Frederick, submitted an emergency temporary standard (ETS) draft to the White House’s Office of Management and Budget (OMB) on Tuesday, October 12^th. This ETS addresses President Biden’s September 9^th COVID-19 Action Plan mandating that employers ensure their workforces are fully vaccinated or show a negative test at least once a week. The mandates will apply to businesses with 100 or more employees and affect more than 80 million workers. The last COVID-19 related ETS took six weeks for the OMB to approve.

While many employers have already issued vaccination and/or testing requirements for their employees, others are waiting for OSHA to publish the ETS before they pass requirements onto their employees.

Coverage for Employer-Mandated Testing 

With OSHA’s vaccination and testing requirements imminent, we are seeing an increase in questions from employer groups related to plan coverage of employer-mandated COVID-19 testing. Such testing, falls into the same category as other examinations and treatments required to obtain and maintain employment. Such expenses are typically excluded from health plan coverage. We have a small number of clients that have chosen to amend their plan language to cover asymptomatic COVID-testing for all plan members (not just members who are also employees). In these cases, we accept COVID-19 testing claims regardless of the reason that the test is requested and apply the plan’s designated benefit coverage.

New COVID Treatments  

Vaccines remain the most effective treatment to prevent the spread of COVID-19.

Yet, scientists continue the race to develop effective treatments for those facing a fight for their lives with COVID-19 infections. This week showed promise for a potential at-home treatment for those suffering from less aggressive cases.

On October 11^th, pharmaceutical giant, Merck, applied for emergency use authorization (EUA) for its Molupiravir antiviral pill to treat COVID-19. Merck and Ridgeback Biotherapeutics’ phase 3 trial results showed a 50% reduced risk of hospitalization or deaths compared to a placebo group in patients with mild to moderate COVID-19 infections. The New York Times reports that the U.S. government has ordered doses to treat approximately 1.7 million patients at approximately $700 each.

On October 7^th, the National Institutes of Health (NIH) updated its COVID-19 Treatment Guidelines regarding the use of anti-SARS-CoV-2 monoclonal antibodies. In a nutshell, because of supply and logistical constraints making it impossible to offer this treatment to all eligible COVID-19 patients, the NIH panel recommended clinicians prioritize use of anti-SARS-CoV-2 monoclonal antibodies therapy for patients at highest risk of severe COVID-19 progression.

Last month, as the delta variant surged, we saw counties in WA, ID, and AK, invoke crisis standards of care for the first time ever. We have yet to understand fully the toll wreaked by this standard of care crisis. The good news is that as COVID-19 vaccination rates rise, COVID-19 hospitalizations fall and free up some capacity for our overwhelmed hospital systems to treat non-COVID patients at appropriate standards of care.

Our Care Management and Customer Care teams reported a high rate of elective surgeries requiring hospital admission postponed and they worked closely with your people to help them understand the situation and explore their options. We are not yet seeing an uptick in pre-authorization requests for in-patient procedures.

Booster and Vaccine Update

On October 14^th, the FDA’s Advisory Committee on Vaccines and Related Biological Products met to review data from the use of booster doses in Israel relevant to the need for boosters and hear from Moderna Therapeutics about the safety and immunogenicity of a 50 microgram booster dose of its vaccine given at least six months after following completion of the primary series.  The committee voted unanimously to recommend approval by the FDA of the Moderna booster half dose to the same group of older and high risk individuals that it recommended for the Pfizer booster.

Today, October 15^th, the FDA will walk through the same process to evaluate and vote on a Janssen/ Johnson & Johnson booster dose given two to three months after the first dose or as a booster about six months after the first dose. Additionally, the FDA will evaluate and determine recommendations around ‘heterologous boosting’ or intermingling of vaccine initial series and booster brands.

While the Pfizer-BioNTech single booster dose vaccine received FDA emergency use approval on September 22^nd, the FDA limited approval to the highest risk populations six months after the completion of their ‘primary’ two doses:

individuals 65 years of age and older;

individuals 18 through 64 years of age at high risk of severe COVID-19; and

individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Later this month, on October 26^th, the same FDA committee will reconvene to evaluate and vote on the emergency use authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

Following each FDA vaccine approval, the CDC typically conducts a review and issues its own vaccine recommendation.

We will continue to monitor closely the FDA’s vaccine approvals and the CDC’s recommendations for COVID-19 vaccine boosters and treatments. While the federal Public Health Emergency declaration remains in place, plans are required to cover COVID-19 vaccines including boosters that have emergency use approval (EUA) by the FDA and follow CDC recommendations. Additionally, once a vaccine receives full FDA approval it is considered a preventive care covered benefit under the CARES Act which applies to all non-grandfathered group health plans under the ACA rules.

Regular COVID Reporting Continues

All clients currently receive regular reporting on their plan’s COVID-related claims and payments. Please connect with your Account Manager to receive your latest report or you can access this report in BenefitFocus. 

Our focus, dedication, and support remain steadfast as we navigate these unique times with you. Know that our Care Management nurses are reaching out to those members diagnosed with COVID-19 to help them access the care and resources they need to recover safely.

Updated COVID-19 Member Information and Resources on Our Website

We update our COVID-19 information and resource pages for members regularly. Many members call us with questions that are of a more clinical nature. We recommend that members consult their primary care physician for clinical questions. For non-clinical questions, please share this page with members where they will find links to additional resources on self-care, vaccines, and other useful information.