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.
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) emergency use authorization (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 a single booster dose, as follows:
- October 20, 2021: Janssen COVID-19 vaccine (Johnson & Johnson) (all patients 18 years and older)
- November 19, 2021: Moderna COVID-19 vaccine (PDF) (all patients 18 years and older)
- January 3, 2022: Pfizer-BioNTech COVID-19 vaccine (PDF) (all patients 12 years and older)
|The FDA amended the Pfizer-BioNTech EUA on September 22, 2021, and the Moderna EUA on October 20, 2021, to authorize the use of a single booster dose 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 again on November 19, 2021, to authorize the use of such a single booster dose for all patients 18 years and older. On December 9, 2021, the FDA amended the Pfizer-BioNTech EUA to authorize the use of the single booster dose for all patients 16 years and older. On January 3, 2022, the FDA amended the Pfizer-BioNTech EUA to authorize the use of the single booster dose 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.|
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
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:
- Call 1-800-HHS-TIPS
- Submit an online complaint
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 can request reimbursement for the administration of the COVID-19 vaccine through the Health Resources & Services Administration (HRSA) COVID-19 Uninsured Program.
- Providers administering the vaccine to underinsured individuals can request reimbursement for the administration of the COVID-19 vaccine through the HRSA COVID-19 Coverage Assistance Fund for people in these situations:
- 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:
- How you can enroll in Medicare to bill for administering COVID-19 vaccines
- The COVID-19 vaccine Medicare coding structure
- Medicare payment rates for administering COVID-19 vaccines
- How to bill correctly for administering vaccines, including roster and centralized billing
- Monoclonal antibody infusion for treating COVID-19
- New COVID-19 Treatments Add-on Payment (NCTAP)