SPECIAL BULLETIN COVID-19 #198: Pfizer Vaccine for 12 Years and Older

Pfizer-BioNTech COVID-19 Vaccine Billing Guidelines

NOTE: March 8, 2022. The first sentence of this bulletin was edited to change the effective date of service from Sept. 29, 2021, to Jan. 3, 2022. 

Pfizer-BioNTech COVID-19 Vaccine (12 years of age and older) - HCPCS code 91305: Billing Guidelines

Effective with date of service Jan. 3, 2022, the Medicaid and NC Health Choice programs cover Pfizer-BioNTech COVID-19 Vaccine (12 years of age and older) - does not require dilution for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code 91305 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, for intramuscular use.

Strength/Package Size(s): 

Injection: Pfizer-BioNTech COVID-19 Vaccine is a preservative-free, frozen suspension for injection in a multiple dose vial that does not require dilution (gray cap).

Emergency Use Authorizations: 

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an EUA for a single booster dose in individuals:

• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

FDA-Approved Indications:

Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

See code 91307 for information regarding approved uses for individuals five through 11 years of age.
See code 91300 for information regarding approved uses for vials that require dilution for individuals 12 years of age and older.

Recommended Dose:

PRIMARY SERIES:
For individuals 12 years of age or older:

• The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart.
• Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.
• A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
• Notwithstanding the age limitations for use of the different formulations and presentations described, individuals who will turn from 11 years to 12 years of age between their first and second dose in the primary regimen may receive, for either dose, either:
  • the Pfizer-BioNTech COVID-19 Vaccine formulation authorized for use in individuals five through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA) (orange cap); or
  • Comirnaty or one of the PfizerBioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA) (gray and purple caps).

BOOSTER DOSE:
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered intramuscularly at least six months after completing the primary series to individuals:

• 65 years of age and older
• 18 through 64 years of age at high risk of severe COVID-19
• 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

See code 91307 for information regarding recommended dosing for individuals five through 11 years of age.
See code 91300 for information regarding recommended dosing for vials that require dilution for individuals 12 years of age and older.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing:

• The ICD-10-CM diagnosis code required for billing is:  Z23 - Encounter for immunization.
• Providers must bill with HCPCS code:  91305 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, for intramuscular use.
• One Medicaid and NC Health Choice unit of coverage is: 0.3 mL
• The maximum reimbursement rate per unit is: N/A
• Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 59267-1025-01, 59267-1025-02, 59267-1025-03, 59267-1025-04.
• The NDC units should be reported as "UN1"
• For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
• The fee schedule for the PADP is available on Medicaid's PADP web page.

Important Claims Information:

• Medicaid and NC Health Choice will reimburse at the Medicare approved COVID-19 vaccination administration rate at $40.
• Claims must have appropriate NDCs that correspond to the vaccine used for administration and corresponding CPT code.
• Claims must contain both administration codes and vaccine codes to pay.
• Vaccine codes should be reported as $0.00.
• Medicaid and NC Health Choice do not allow copays to be charged for COVID-19 immunization or administrations.
• COVID-19 vaccines are exempt from the Vaccines For Children (VFC) program.
• Pharmacies may administer Pfizer PEDIATRIC COVID-19 Vaccines to any Medicaid and NC Health Choice beneficiary as per FDA age approval. All other vaccines (non-COVID-19 vaccines), that are approved by the NC Board of Pharmacy to be administered by a pharmacist, are only permissible to be administered at a pharmacy for Medicaid beneficiaries 19 years and older. 
• TJ modifier should be appended to all NC Health Choice claims (through 18 years).
• EP modifier should be appended to all non-NC Health Choice (only Medicaid beneficiaries) younger than 21 years of age.
• CG modifier should be appended to ALL COVID-19 vaccine AND administration claims submitted by a pharmacy participating in the immunization program.

COVID-19 Vaccine Billing Codes

Vaccine CPT Codes for COVID-19 Vaccines to Report

Administrative CPT Codes for COVID-19 Vaccines to Bill

Contact

NCTracks Contact Center: 800-688-6696