AMA Issues Unique CPT Codes for Janssen COVID-19 Vaccine

January 20, 2021 - The American Medical Association (AMA) has added new codes to the Current Procedural Terminology (CPT) code set to account for the COVID-19 vaccine candidate from Janssen Pharmaceutica, a division of Johnson & Johnson.

The codes – 91303* and 0031A – can be used to document and bill for Janssen’s single-dose vaccine and its administration when the Food and Drug Administration (FDA) approves the vaccine candidate or grants it emergency use authorization, according to a recent announcement.

Janssen’s COVID-19 vaccine is the fourth vaccine candidate to get its own CPT code from AMA, following the candidates from Pfizer, Moderna and AstraZeneca. The Association previously issued unique CPT codes for the three vaccine candidates and immunization administration, including the first and second doses of the two-dose vaccines from all three companies.

“Janssen’s single-dose COVID-19 vaccine would mark a big change from the double-dose vaccines currently available,” said Susan R. Bailey, MD, AMA president and CEO, said in the announcement. “The change will place greater importance on accurately reporting COVID-19 immunizations by vaccine type and dose to ensure patients complete the appropriate immunization schedule.”

“Unique CPT codes that clinically distinguish each COVID-19 vaccine provide the needed informational precision to ensure optimal vaccine distribution and administration,” Bailey stated.

An FDA approval for the COVID-19 vaccine from Janssen is still “weeks away,” according to the nation’s top infectious disease expert Anthony Fauci who spoke with NBC’s “Meet the Press” on Sunday.

But the single-dose vaccine candidate is generating positive results, according to Johnson & Johnson.

The pharmaceutical company released data from an interim Phase 1/2a clinical trial late last week showing that the investigational COVID-19 vaccine candidate (JNJ-78436735) provided an immune response for at least 71 days.

JNJ-78436735 was also well-tolerated across all study participants, the data revealed.

Johnson & Johnson, which has funneled development of the vaccine candidate to Janssen, expects more data from a Phase 3 clinical trial in late January 2021, when it plans to submit an application for emergency use authorization to the FDA if results show the vaccine candidate to be safe and effective.

But “time is approximate,” the company stated, since the trial is “dependent on disease events.”

Fauci also expects an emergency use authorization for AstraZeneca’s COVID-19 vaccine candidate in the coming weeks.

AMA developed unique CPT codes for the AstraZeneca vaccine and its administration in December 2020.

The latest codes to be added to the CPT code set are:

• 91303: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x1010 viral particles/0.5mL dosage, for intramuscular use
• 0031A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x1010 viral particles/0.5mL dosage, single dose

Other vaccine-specific CPT codes approved by the AMA include codes 91302, 0021A, and 0022A for AstraZeneca’s vaccine and administration; 91300, 0001A, and 0002A for Pfizer’s vaccine and administration; and 91301, 0011A, and 0012A for Moderna’s vaccine and administration.

Short, medium, and long descriptions for all the new vaccine-specific CPT codes can also be accessed on the AMA website. The Association also offers on its website other recent modifications to the CPT code set related to COVID-19 and the public health response effort.

AMA is also publishing the two new CPT codes now to ensure EHR systems are updated and providers are prepared for any FDA approvals for authorization for the Janssen COVID-19 vaccine.

CORRECTION: In a previous version of this article, the CPT code was incorrect. The article has been corrected to reflect the right CPT code.