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COVID-19

CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine. These resources are designed to increase the number of providers that can administer the vaccine and ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID treatments that are approved by the FDA.

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Issued by: Centers for Medicare & Medicaid Services (CMS)

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 29, 2022, the FDA amended emergency use authorizations (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 emergency use authorization (EUA), including: 

  • 2-dose primary series for patients 18 years and older
  • 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 emergency use authorization (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:
The FDA amended the Pfizer-BioNTech EUA on September 22, 2021, and the Moderna EUA on October 20, 2021, to authorize the use of first booster doses for certain populations after completion of a primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The FDA amended both of these EUAs on November 19, 2021, to authorize the use of first booster doses for all patients 18 years and older. On December 9, 2021, the FDA amended the Pfizer-BioNTech EUA to authorize the use of first booster doses for all patients 16 years and older. On January 3, 2022, the FDA amended the Pfizer-BioNTech EUA to authorize the use of first booster doses for all patients 12 years and older and third pediatric doses for 5–11-year-old solid organ transplant patients or patients with a similar level of immunocompromise. On March 29, 2022, the FDA amended the Pfizer-BioNTech EUA to authorize the use of second booster doses for all patients 50 years and older and certain immunocompromised patients 12 years and older, and they amended the Moderna EUA to authorize the use of second booster doses for all patients 50 years and older and certain immunocompromised patients 18 years and older.


Effective April 23, 2021, the CDC and FDA recommended that use of the Janssen COVID-19 vaccine resume in the U.S. However, providers should inform women under 50 years old about:

  • A rare risk of blood clots with low platelets following vaccination
  • The availability of other COVID-19 vaccines where this risk hasn’t been observed

Learn more about the joint CDC and FDA recommendation, and review the Jansen COVID-19 Vaccine Fact Sheet for Health Care Providers.

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:

 

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.