CMS Bulletin: CMS Bolsters Payments for At-Home COVID-19 Vaccinations for Medicare Beneficiaries

As part of President Biden’s commitment to increasing access to vaccinations, the Centers for Medicare & Medicaid Services (CMS) today announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach. There are approximately 1.6 million adults 65 or older who may have trouble accessing COVID-19 vaccinations because they have difficulty leaving home. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.

More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

A New Type Of COVID-19 Vaccine Could Debut Soon

A new kind of COVID-19 vaccine could be available as soon as this summer.

It's what's known as a protein subunit vaccine. It works somewhat differently from the current crop of vaccines authorized for use in the U.S. but is based on a well-understood technology and doesn't require special refrigeration.

In general, vaccines work by showing people's immune systems something that looks like the virus but really isn't. Consider it an advance warning; if the real virus ever turns up, the immune system is ready to try to squelch it.

In the case of the coronavirus, that "something" is one of the proteins in the virus — the spike protein.

The vaccines made by Johnson & Johnson, Moderna and Pfizer contain genetic instructions for the spike protein, and it's up to the cells in our bodies to make the protein itself.

The first protein subunit COVID-19 vaccine to become available will likely come from the biotech company, Novavax. In contrast to the three vaccines already authorized in the U.S., it contains the spike protein itself — no need to make it, it's already made — along with an adjuvant that enhances the immune system's response, to make the vaccine even more protective.

Protein subunit vaccines made this way have been around for a while. There are vaccines on the market for hepatitis B and pertussis based on this technology.

A large test of the Novavax COVID-19 vaccine's effectiveness, conducted in tens of thousands of volunteers in the United States and Mexico, is about to wrap up. Dr. Gregory Glenn, president of research and development for Novavax, told an audience at a recent webinar hosted by the International Society for Vaccines that "we anticipate filing for authorization in the U.K., U.S. and Europe in the third quarter."

Turning plants into factories

To make the virus protein, Novavax uses giant vats of cells grown in the lab. But there's another way to make the protein: Get plants in a greenhouse to do it.

That's the approach being used by the Canadian biotech firm Medicago.

The plants used are related to the tobacco plant, and have been modified to contain the genetic instructions to make the viral protein.

The plants do something very valuable — they make a lipid shell that surrounds a bunch of the viral proteins, with the proteins sticking out.

"The plant will assemble the protein in a shape and form that is looking like the virus," says Nathalie Landry, Medicago's executive vice president for scientific and medical affairs. "So, if you look at an image of it, it looks like a virus, but it cannot induce any disease. But when [it's] injected as a vaccine your body will raise a good immune response."

Early studies suggest Medicago's candidate vaccine does just that, and the company is confident enough in those findings that it's already begun a large study in people that could involve as many as 30,000 volunteers in 11 countries.

EEOC Issues COVID-19 Vaccine Guidance for Employers

From SESCO Management Consultants

The U.S. Equal Employment Opportunity Commission (EEOC) has issued new COVID-19 vaccine guidance for employers. The new guidance addresses topics the EEOC either left unclear or did not expressly resolve in earlier publications.

Confidentiality

- Information about an employee’s vaccination status is considered “confidential medical information” under the Americans with Disabilities Act (ADA).

- Like all medical information, information about an employee’s vaccination status must be kept confidential and stored separately from the employee’s personnel file. Unfortunately, with this general rule in mind, the EEOC has not yet offered guidance for employers on how to easily identify the vaccination status of employees at the workplace to enforce ongoing mask mandates for non-vaccinated workers (e.g., via a badge or other outward identifier).

Employer Inquiries

- Employers may ask employees whether they obtained the vaccine from a third party in the community (pharmacy, personal doctor, etc.), and this question is not a “disability-related inquiry.”

- Employers may ask employees to provide documentation or other confirmation of the vaccination from such sources without the request being a “disability-related inquiry.”

Vaccinating Subsets of Employees

- Employers may offer vaccinations to certain groups of employees and not to others (e.g., assembly versus office workers), so long as the employer does not discriminate in the offering based on a protected class.

Vaccine Incentives

- Employers may offer incentives to employees who voluntarily receive the vaccine from a third-party vaccine provider (health department, pharmacy, personal medical provider, etc.).

- Employers may offer incentives to employees to voluntarily provide documentation that they received the vaccine from a third-party vaccine provider.

- Employers may offer incentives to employees who voluntarily receive a vaccination administered by the employer or its agent, so long as the incentive is not “so substantial as to be coercive.” One gap in the guidance provided by the EEOC is any further discussion of what constitutes a "coercive" incentive. What is so substantial as to be coercive and thus no longer voluntary under the ADA? Hopefully, the EEOC will further clarify this question but an incentive under $500 would likely be permissible. This was a central issue in the EEOC’s prior efforts to delineate regulations covering permissible incentives related to employer-sponsored wellness plans under the ADA. Although the EEOC had released new Trump-era wellness regulations in January 2021, they had not yet been published in the Federal Register when President Biden took office, and so they were withdrawn.

- Employers may not offer an incentive to an employee in return for the employee’s family member getting vaccinated by the employer or its agent.

- Employers may offer to vaccinate family members without offering the employee an incentive. However, employers must not require employees to have their family members get vaccinated and must not penalize employees if their family members decide not to do so. Employers must also ensure all medical information obtained from family members during the screening process is used only for the purpose of providing the vaccination, is kept confidential and is not provided to any managers, supervisors or others who make employment decisions for the employees.

SESCO Management Consultants will continue to monitor and report on developments with respect to the COVID-19 pandemic and will post updates in the firm’s COVID-19 Resource Center as additional information becomes available.

SESCO retainer clients and members of select associations can call or email SESCO to discuss specific industry, state and/or company questions and concerns. Those receiving these alerts that are not SESCO clients can contact SESCO by phone, fax or email to explore support options.  https://sescomgt.com/contact 

Vaccinating Our Children 

From the National Institute for Health Care Management (NIHCM)

Vaccination efforts are now focused on young people and as of June 3rd, about 20% of children ages 12-15 have received their first COVID-19 vaccine. Vaccinating children against COVID-19 is essential in reaching herd immunity. Teens should see widespread vaccine availability by the time school starts in the fall, which may also enable some parents to more easily return to the workplace. 

Raising Rates: Increasing vaccination rates among children will require continued communication and outreach, particularly towards the parents who play a critical role in the success of these efforts. 

Younger Children: Children under 12 will likely be eligible for the vaccine in the fall and vaccine trials for children five and younger are currently underway. 

Vaccine Equity: There are nearly half a million foster and migrant children who may not be able to receive the COVID-19 vaccine, which requires a guardian’s consent and vaccine consent laws vary by state.  

Resources:

The CDC has answers to parents’ questions on getting their children and teens the COVID-19 vaccine and evidence of the vaccine’s safety

NIHCM grantee, Journalist’s Resource, has gathered research studies that can provide journalists with background and sources so they can report on COVID-19 vaccines in children.

See the CDC’s recent guidance for summer camps, which says that vaccinated children do not need to wear masks.