What is the Serve You Rx recommendation for coverage?

Pharmacy benefit coverage of COVID-19 vaccines is to be added to all commercial self-funded plans (grandfathered and non-grandfathered) by start of 2021.

Why does Serve You Rx recommend coverage of COVID-19 vaccines?

On October 28, 2020, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued an interim final rule (IFR) to implement the requirement under the Coronavirus Aid, Relief, and Economic Security (CARES) Act for group health plans to cover qualifying COVID-19 preventive services without cost sharing.

Can the Plan delay implementing coverage?

Under the Affordable Care Act’s (ACA) preventive care mandate, a non-grandfathered group health plan typically has at least one year before it must provide first-dollar coverage for a newly issued preventive care requirement or guideline; however, the CARES Act significantly shortens this timing for any qualifying Coronavirus preventive service. Specifically, non-grandfathered group health plans must cover such a service 15 business days after the United States Preventive Services Task Force (USPSTF) or the Advisory Committee on Immunizations Practices (ACIP) designates it as preventive. On December 12, 2020, ACIP issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.

What is the cost to the member for COVID-19 vaccination?

Each vaccine is available to all American people at $0 cost sharing. However, vaccine providers can charge a fee for administering the shot. Vaccine providers can get this fee reimbursed by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund.

What is the cost to the Plan for COVID-19 vaccinations?

The vaccines will be paid for through funding authorized by the CARES Act, but administration of the vaccine by a provider will be paid for by the payer (for example, the private insurance company).

The cost of coverage (administration fee) is expected to be equivalent to the Medicare payment rates. Medicare payment rates for COVID-19 vaccine administration will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of 2 or more doses, the initial dose(s) administration payment rate will be $16.94, and the administration of the final dose in the series will be $28.39. These rates recognize the costs involved in administering the vaccine, including the additional resources involved with required public health reporting, conducting important outreach and patient education, and spending additional time with patients answering any questions they may have about the vaccine. These rates may also be geographically adjusted.

What is the status of FDA approval and guidelines for safe COVID-19 vaccine use?

On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID-19 Vaccine for the prevention of Coronavirus Disease 2019 for individuals 16 years of age and older. The vaccines were not studied in the pediatric population, and ACIP will be convened by the CDC to offer advice on who should get specific vaccines and when. Officials have stated that further guidance would be forthcoming.

What is an Emergency Use Authorization?

An EAU is mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency, to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

What COVID-19 vaccines are expected to be granted EUA and available in December 2020?

Two manufacturers are anticipated to have vaccines approved and distributed before the end of 2020:

Pfizer-BioNTech COVID-19 Vaccine — first shipments likely to occur week of 12/14/20

Moderna, Inc. COVID-19 Vaccine — authorization possible by third week of December 2020

Both vaccines will require a series of two doses to achieve expected efficacy.

What are the plans for vaccine distribution?

On December 1, 2020, the Advisory Committee on Immunization Practices made recommendations on who should be offered COVID-19 vaccination in the initial phase of the U.S. COVID-19 vaccination program while there is limited vaccine supply. During Phase 1 of the COVID-19 vaccination program, the vaccine should be offered to both

Healthcare personnel — paid and unpaid people serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials

Long-term care facility residents — adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently

Beginning in December 2020, COVID-19 vaccines will be available in limited quantities and offered to select groups as determined by federal, state, and local government. You should look to the guidelines issued for your state, locality, or territory and see how your employees fit in.

Will members need a prescription to receive the COVID-19 vaccine at a retail pharmacy?

No. Once the vaccine is widely available, members should contact their local pharmacy or visit the pharmacy’s website to schedule an appointment and/or pre-screen before arriving for the vaccine.

What is the dosing regimen for the COVID-19 vaccines?

The first two vaccines are two-dose regimens:

Pfizer-BioNTech COVID-19 Vaccine — second dose is 21 days (three weeks) after the first dose.

Moderna Inc. COVID-19 Vaccine — second dose is 28 days (four weeks) after the first dose.

***It is very important to get the second dose to receive the full benefit of the vaccine.***

Do member’s need to go back to the same place to get the second dose?

No. However, since the vaccines differ in composition, storage, and time between the two doses, experts say people must take the same vaccine for both doses.

Where can members get the vaccine administered?

Several thousand vaccination providers will be available, including doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers.

Visit CDC’s VaccineFinder at: https://vaccinefinder.org/find-vaccine

VaccineFinder will be updated once COVID-19 vaccination is widely available to the public to help direct people to find a vaccine provider near them.

Where can members get information about the COVID-19 vaccinations?

Member information and FAQs are available on Serve You Rx’s website. We also encouraged members to refer to the CDC website (cdc.gov), local health authority or public health department, and the member’s prescriber or local pharmacist.

As a client or partner of Serve You Rx, where can I get more information? I have a clinical questions, who can help me? (e.g. Should I get vaccinated? What are the side effects?)

For more information, please refer to the CDC website, your local health authority or public health department, your doctor, or your local pharmacist. For a clinical question, please reach out to your Serve You Rx Clinical Account Executive.