COVID-19

This toolkit is for health care providers.

If you're a person with Medicare, learn more about your Medicare coverage for COVID-19 vaccines, and find a COVID-19 vaccine near you.

On March 14, 2023, the FDA amended the emergency use authorization (EUA) of the updated (bivalent) Pfizer-BioNTech (PDF) COVID-19 vaccine to include a single booster dose of the vaccine in children 6 months – 4 years old at least 2 months after completion of primary vaccination with 3 doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 vaccine.

On December 8, 2022, the FDA amended the EUAs of the updated (bivalent) Pfizer-BioNTech (PDF) and Moderna (PDF) COVID-19 vaccines to include use in children down to 6 months old. Your patients may know these as “updated COVID-19 vaccines”:

Timeline of Previous COVID-19 Vaccine EUAs

On October 19, 2022, the FDA amended the Novavax COVID-19 vaccine, Adjuvanted EUA to authorize the use of a first booster dose for patients 18 years and older:

  • For whom an FDA-authorized bivalent (updated) booster isn’t accessible or clinically appropriate
  • Who choose to get the Novavax booster because they wouldn’t otherwise get a COVID-19 booster

On October 12, 2022, the FDA amended the Pfizer-BioNTech (PDF) and Moderna (PDF) COVID-19 vaccine EUAs to authorize bivalent formulations of the vaccines for use as a single booster dose in younger age groups. Your patients may know these as “updated COVID-19 vaccines”:

On August 31, 2022, the FDA amended the Pfizer-BioNTech (PDF) and Moderna (PDF) COVID-19 vaccine EUAs to authorize bivalent formulations of the vaccines for use as a single booster dose. Your patients may know these as “updated COVID-19 vaccines”:

  • Pfizer-BioNTech: all patients 12 years and older
  • Moderna: all patients 18 years and older

On August 19, 2022, the FDA amended the Novavax COVID-19 vaccine, Adjuvanted EUA to authorize the use for all patients 12–17 years old.

On July 13, 2022, the FDA authorized emergency use of the Novavax COVID-19 vaccine, Adjuvanted for the prevention of COVID-19 disease in patients 18 years and older.

On June 17, 2022, the FDA authorized emergency use of the Moderna and Pfizer-BioNTech vaccines for the prevention of COVID-19 to include use in children as young as 6 months:

On May 17, 2022, the FDA amended the Pfizer-BioNTech COVID-19 vaccine (PDF) EUA to authorize the use of a single booster pediatric dose (orange cap) for all patients 5-11 years old.

On May 5, 2022, the FDA limited the authorized use of the Janssen COVID-19 vaccine to:

  • Patients 18 years and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate
  • Patients 18 years and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine

On March 29, 2022, the FDA amended EUAs to authorize the use of second booster doses as follows:

On January 31, 2022, the FDA approved the Moderna COVID-19 vaccine, marketed as SPIKEVAX, for the prevention of COVID-19 disease in patients 18 years and older. The vaccine remains available under EUA, including:

  • Third primary series dose in certain immunocompromised patients 18 years and older
  • Single booster dose for patients 18 years and older

The FDA authorized an additional formulation (gray cap) for the Pfizer-BioNTech COVID-19 vaccine (PDF) for patients 12 years and older. This pre-diluted vaccine is effective January 3, 2021.

On January 3, the FDA amended the Pfizer-BioNTech COVID-19 vaccine (PDF) EUA to authorize the use of third pediatric doses (orange cap) for 5–11-year-old solid organ transplant patients or patients with a similar level of immunocompromise.

The FDA amended EUAs to authorize the use of first booster doses, as follows:

On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine, marketed as COMIRNATY®, for the prevention of COVID-19 disease in patients 16 years and older. The vaccine remains available under EUA, including:

  • 2-dose primary series for patients 5 years and older
  • Third primary series dose in certain immunocompromised patients 5 years and older
  • Single booster dose for patients 12 years and older
Note:
Visit Medicare COVID-19 Vaccine Shot Payment for a timeline of FDA approvals and EUA amendments for COVID-19 vaccines.

 

Note:

Patients who are moderately or severely immunocompromised (have a weakened immune system) are at increased risk of severe COVID-19 illness and death. And, the immune response following COVID-19 vaccination may differ for these patients. Learn about COVID-19 vaccine guidance for moderately or severely immunocompromised patients.

 

CMS released this toolkit for providers, and a set of toolkits for states and insurers designed to:

  • Help the health care system quickly administer vaccines as they're available
  • Increase the number of providers who can administer the vaccine
  • Ensure adequate Medicare payment for administering the vaccine
  • Ensure private insurers and Medicaid programs understand their responsibility to cover the vaccine at no cost to patients

We're also taking action to increase payment for any new FDA-approved COVID-19 treatments.

Health care providers play an important role and we're committed to ensuring you have the necessary tools to respond to the COVID-19 public health emergency (PHE). Because the federal government purchased the initial supply of COVID-19 vaccines, this toolkit primarily focuses on coverage for administering the vaccine. Americans can get vaccines purchased with U.S. taxpayer dollars at no cost. HHS issued a letter reminding the following:

  • Health care providers about your signed agreements to administer COVID-19 vaccines to patients free-of-charge
  • Group health plans and health insurers that you’re legally required to cover COVID-19 vaccines and diagnostic testing without patient cost sharing

If you participate in the CDC COVID-19 Vaccination Program, you must:

  • Administer the vaccine with no out-of-pocket cost to your patients for the vaccine or administration of the vaccine
  • Vaccinate everyone, including the uninsured, regardless of coverage or network status

You also can’t:

  • Balance bill for COVID-19 vaccinations
  • Charge your patients for an office visit or other fee if COVID-19 vaccination is the only medical service given
  • Require additional medical or other services during the visit as a condition for getting a COVID-19 vaccination

Report any potential violations of these requirements to the HHS Office of the Inspector General:

Providers who have questions about billing or reimbursement of vaccine administration for patients covered by private insurance or Medicaid should contact the respective health plan or state Medicaid agency. People without health insurance or whose insurance doesn't provide coverage of the vaccine can also get COVID-19 vaccines at no cost.

  • Providers administering the vaccine to people without health insurance were able to request reimbursement for the administration of the COVID-19 vaccine through the Health Resources & Services Administration (HRSA) COVID-19 Uninsured Program. On April 5, 2022, at 11:59 pm ET, the HRSA COVID-19 Uninsured Program stopped accepting vaccination claims due to insufficient funds. If you submitted a claim before the deadline, the claim will be paid subject to eligibility and availability of funds.
  • Providers administering the vaccine to underinsured individuals were able to request reimbursement for the administration of the COVID-19 vaccine through the HRSA COVID-19 Coverage Assistance Fund for people in the situations listed below. On April 5, 2022, at 11:59 pm ET, the Coverage Assistance Fund stopped accepting vaccination claims due to insufficient funds. If you submitted a claim before the deadline, the claim will be paid subject to eligibility and availability of funds.
    • They only have Medicare Part A but not Part B coverage (or supplemental coverage for Part B services, like vaccine administration)
    • Their insurance doesn’t include the COVID-19 vaccine administration fees as a covered benefit (like Medicare Part A only)
    • Their health insurance covers the COVID-19 vaccine administration but with cost sharing
       

What’s in the Toolkit?

We’ll update this toolkit as new information becomes available.

This toolkit includes information to describe:

 

Related Links

Page Last Modified:
03/30/2023 09:16 AM
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