Originally published September 3, 2021
Updated September 30, 2021
Effective for dates of service on or after August 12, 2021, the US Food and
Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the
Pfizer-BioNTech and Moderna COVID-19 vaccines to permit the administration of a third
dose to certain individuals with compromised immune systems. For the most current
direction regarding guidelines for use of these vaccines, including how to bill for the administration of a third dose, refer to the following
COVID-19 vaccine web pages:
To assist providers, billing guidelines specific to
administration of a third dose are published below.
Providers should note that all billing guidelines included below are only current as of
the publication of this article.
General Policy
- The third dose should be administered no earlier than 28 days following the
two-dose regimen of the same vaccine to individuals who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have an
equivalent level of immunocompromise.
- Age restrictions for use of the vaccine product are not changed with this update.
- The policy for maximum allowable reimbursement is not changed with this update.
Pharmacy Claims
- Use previously published NDCs associated with the Pfizer-BioNTech and Moderna
COVID-19 vaccines to indicate the third dose in claims submitted both electronically
and on paper. In addition,
- When submitting electronic claims utilizing NCPDP D.0, NCPDP 1.2, or RTIP
transactions, providers should use Submission Clarification Code (SCC) 7 to
indicate that a third dose of a COVID-19 vaccine is being administered and
billed.
- When submitting hard copy claims, providers should enter either a 3 or 03 in the
Fill Number field (Box 12) to indicate that the third dose is being administered
and billed.
- Batch (NCPDP 1.2) and paper claims (30-1) may be suspended upon submission until
further system updates required to properly adjudicate those claims are implemented.
Pharmacy providers will be informed when these system updates are implemented.
Medical and Outpatient Claims
- Pfizer-BioNTech: Administration of a third dose must be indicated by using
CPT® code, 0003A.
- Moderna: Administration of a third dose must be indicated by using CPT code, 0013A.
FDA Approval of Pfizer-BioNTech COVID-19 Vaccine
On August 23, 2021, the FDA formally approved the biologics license application
(BLA) for Pfizer-BioNTech’s COVID-19 vaccine, commercially known as Comirnaty. As
of the publication of this article, the FDA approval applies to the administration of
the vaccine in individuals 16 years of age and older.
The original Pfizer-BioNTech COVID-19 vaccine EUA still remains in effect, however, and
allows individuals 12 through 15 years of age to receive the Pfizer-BioNTech COVID-19
vaccine. It also allows for the administration of a third dose to certain
immunocompromised individuals.
Medi-Cal’s policy regarding the Pfizer-BioNTech vaccine and the administration of
the vaccine, with respect to the formal FDA approval of the Comirnaty product and the
existing EUA, remains unchanged as of the original publication of this article.
Providers should refer to the Pfizer-BioNTech COVID-19 Vaccine web page on the Medi-Cal website for the most current billing guidelines that should be followed when submitting a claim to Medi-Cal for the administration of a Pfizer-BioNTech COVID-19 vaccine.
Additional Information
The NCPDP Payer Sheet is updated as of the publication of this
article. Provider manual updates reflecting these changes will be released in a future Medi-Cal Update.
This guidance is only effective for COVID-19 vaccines purchased by the federal government. At a future date, DHCS will provide an end date to this temporary policy and instruct providers on how they should bill for the reimbursement of provider purchased COVID-19 vaccines.
Providers with questions should contact the Telephone Service Center (TSC) Help Desk at 1-800-541-5555, 8 a.m. to 5 p.m., Monday through Friday, except holidays. Border providers and out-of-state billers
billing for in-state providers, should call 1-916-636-1200.
