THOMAS WEIDA, MD, FAAFP, AND JANE WEIDA, MD, FAAFP
Updated Aug. 2, 2022. See also the AAFP's COVID-19 Vaccine page.
Indications and formulations for the COVID-19 vaccines continue to change. To keep up with the changing requirements related to COVID-19 vaccines — including boosters, coding, and vaccines for children — practice staff can use Table 1 as a quick reference guide. Additionally, the Centers for Disease Control and Prevention (CDC) site for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States has more specific guidelines regarding exceptions and modifications.
On Sept. 22, 2021, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the Pfizer COVID-19 vaccine booster in selected cases, followed by an EUA for Moderna and Janssen boosters on Oct. 20, 2021. On Nov. 2, 2021, the CDC director recommended Pfizer’s low-dose COVID vaccine primary series for children ages 5 to 11, following the Oct. 29 emergency use authorization by the FDA.
On Nov. 9, 2021, the CDC expanded the indications for COVID-19 booster vaccines to include everyone 18 and older. Any of the three available vaccines can be used to booster any primary series (“mix and match” dosing); however, the mRNA vaccines are preferred. The primary series should be given with the same vaccine and not interchanged with another vaccine.
On Jan. 4, 2022, the CDC shortened the recommended time between completing the primary series of the Pfizer vaccine and getting a booster to five months. Three days later, the agency did the same for the Moderna vaccine and booster. On Jan. 5, 2022, the CDC expanded the indications for the Pfizer booster to include children age 12 to 17.
On Feb. 22, 2022, the Centers for Disease Control and Prevention (CDC) extended the interval between the first and second doses of the mRNA COVID-19 vaccines (Moderna and Pfizer) to eight weeks for individuals 12 and older. This change is believed to increase the vaccines' duration of protection and reduce the rare risk of myocarditis. The recommended interval for those 5-11 years of age receiving the low-dose Pfizer vaccine remained at three weeks. Also, for the Pfizer vaccine, those who are moderately to severely immunocompromised, those who are 65 years and older, or those who need rapid protection due to increased community transmission should follow the original three-week interval for their second dose and four-week interval for their third dose (which is included in the primary series for people who are moderately to severely immunocompromised). For those who are 65 years and older or immunocompromised and receiving the Moderna vaccine, the interval between the first and second dose is still 28 days, and the interval between the second and third dose is 4 weeks.
On May 19, 2022, the CDC expanded eligibility of a COVID booster vaccine for children ages 5 through 11 years for the Pfizer vaccine. A COVID booster vaccine is not recommended for children who received the Moderna vaccine as a primary series.
On June 17, 2022, the FDA authorized emergency use authorization of the Moderna vaccine in children 6 months through 17 years of age and the Pfizer vaccine in children 6 months through 4 years of age. On June 18, 2022, the CDC approved the recommendation that children 6 months through 17 years of age should receive a COVID-19 vaccine, which should be either the Pfizer or Moderna vaccine.
On July 13, 2022, the FDA authorized emergency use authorization of the Novavax vaccine as a primary two-shot series in adults. On July 19, 2022, the CDC approved the recommendation that adults 18 years and older may receive a 2-dose primary series given 3-8 weeks apart. It is not allowed as a booster dose. Unlike the other COVID-19 vaccines, which instruct the recipient’s cells to make copies of the spike protein, Novavax uses the more traditional protein vaccine approach. Copies of the spike protein are packaged into nanoparticles and combined with an adjuvant to boost the immune response.
The COVID-19 vaccines available in the U.S. have different age ranges, doses, and dosage schedules, as well as different product CPT codes and different administration codes depending on the dose given. Table 1 provides a summary of the coding for each vaccine. When coding, indicate the product code and the administration code on the claim form.
The Pfizer vaccine is now marketed under the FDA-approved brand name COMIRNATY, and it has the same formulation and indications as the EUA Pfizer vaccine for individuals 12 and older. The vaccine needs to be reconstituted with diluent, and the product code is 91300. The first dose administration is coded as 0001A, the second as 0002A, the third as 0003A, and the booster as 0004A.
Pfizer also has a ready-to-use COVID-19 vaccine for individuals 12 years and older that does not need to be reconstituted, a tris-sucrose formulation, which has the same EUA indications as the reconstituted product. The product code is 91305. The first dose administration is coded as 0051A, the second as 0052A, the third as 0053A, and the booster as 0054A.
For children 6 months through 4 years, Pfizer has an EUA COVID-19 vaccine in a 3 mcg/0.2 mL formulation, which needs to be reconstituted. The product code is 91308. The first dose administration is coded as 0081A, the second as 0082A, and the third as 0083A. This is the only COVID-19 vaccine that requires 3 doses for the primary series in individuals who are not immunocompromised. A booster is not approved yet for this age range.
For children 5 to 11 years old, Pfizer has an EUA COVID-19 vaccine in a 10 mcg/0.2mL formulation which needs to be reconstituted. The product code is 91307. The first dose administration is coded as 0071A, the second as 0072A, and the third, if needed, as 0073A. A booster is not approved yet for this age range.
The Moderna vaccine is now marketed under the FDA-approved brand name SPIKEVAX, and it has the same formulation and indications as the EUA Moderna vaccine for individuals 18 years and older. The product code is 91301. The first dose administration is coded as 0011A, the second as 0012A, and the third as 0013A. The first, second, and third doses are all 100mcg/0.5mL. The booster dose, 50mcg/0.25mL, is coded as 0064A, and it is half the volume and strength of the primary vaccine.
Product code 91301 can also be used full strength for ages 12 through 17 years with administration codes 0011A, 0012A, and if needed 0013A. Boosters are not indicated for individuals in this age range who have received Moderna as the primary series.
Moderna also has a 50 mcg/0.5 mL formulation with a product code of 91309, which alternatively can be used as booster doses for individuals 18 years and older with the administration code of 0094A instead of halving the volume of the 91301 product.
Moderna 50 mcg/0.5 mL formulation with product code 91309 is also used for children 6 through 11 years with administration codes 0091A for the first dose, 0092A for the second dose, and if needed 0093A for the third dose. Boosters are not indicated for individuals in this age range who have received Moderna as the primary series.
For children 6 months through 5 years, Moderna has a 25 mcg/0.25 mL formulation with product code 91311. The administration code for the first dose is 0111A, the second dose is 0112A, and the third dose if needed is 0113A.
Janssen vaccine is indicated for individuals 18 years and older, but it is not preferred. The product code is 91301, and the primary series consists of one dose, administration code 0031A. Pfizer or Moderna are preferable for the first booster; however, a Janssen booster dose may be given as the first booster, administration code 0034A. The Janssen vaccine should not be used as a second booster dose in individuals 50 and over. This second booster dose should be a Pfizer or Moderna booster. Additionally, if the first booster dose was Janssen, then all individuals 18 or older should receive a second booster with Pfizer or Moderna.
The Novavax COVID-19, adjuvanted vaccine has a formulation of 100 mcg/0.5 mL and is given as a two-dose primary series. It does not need to be reconstituted. The product code is 91304. The first dose administration code is 0041A, and the second dose is 0042A. Booster doses are not recommended at this time.
A third dose of COVID-19 vaccine is given when a two-dose primary series is deemed insufficient, such as in individuals who are moderately to severely immunocompromised. Indications for the third dose of the Pfizer or Moderna vaccine, which are given at least 28 days after the second dose, are in Table 2.
For the Janssen vaccines, a second dose of COVID-19 vaccine is given when the initial dose is deemed insufficient, such as in individuals who are moderately to severely immunocompromised. This second dose must be an mRNA vaccine (Pfizer or Moderna), which is given at least 28 days after the first dose and has the same indications as the third dose of the Pfizer or Moderna vaccine. If the Moderna COVID-19 vaccine is used for the second dose after the Janssen primary dose, administer a 100mg/0.5mL dose and not the half-strength booster dose.
Table 2: Indications for third-dose COVID-19 vaccine
|Receiving active cancer treatment for tumors or cancers of the blood|
|Organ transplant recipient taking immune suppression medication|
|Stem cell transplant within last two years or taking immune suppression medication|
|Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich)|
|Advanced or untreated HIV infection|
|Active treatment with high-dose corticosteroids (≥ 20 mg prednisone daily for ≥ two weeks)|
|Alkylating agents, antimetabolites, immunosuppressive cancer chemotherapeutic agents, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory|
A booster dose is given when the initial primary COVID-19 vaccine series was sufficient but immunity has decreased over time. In the case of Pfizer or Moderna vaccines, the booster dose is given at least five months after the primary series for people who received two doses and 12 weeks after the primary series for people who received three doses. In the case of Janssen vaccine, the booster dose is given at least two months after the first dose. All people 12 and older should receive an age-appropriate booster dose even if they were 11 or younger at the time of the primary series. Children ages 5-11 who received the Pfizer vaccine as a primary series should receive a booster. The Moderna booster is not indicated at this time for children 6 months through age 17. The Moderna booster vaccine is half the dose of the initial vaccine, and no more than 20 doses should be given from a 10 mL vial. The Pfizer booster is the same strength as the primary series.
For billing, both the product code and administration code linked to it must be submitted. Medicare payment allowances and effective dates are available from the Centers for Medicare & Medicaid Services. Coverage for the booster shots with no cost sharing is available under Medicare, Medicaid, and the Children's Health Insurance Program, as well as in the commercial health insurance market.
Thomas Weida, MD, FAAFP, is Chief Medical Officer, Associate Dean for Clinical Affairs, Professor, The University of Alabama College of Community Health Sciences. Jane Weida, MD, FAAFP, is Chair, Department of Family, Internal and Rural Medicine, Professor, The University of Alabama College of Community Health Sciences.
Posted on Oct. 26, 2021 by FPM Editors
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