Vaccine Code Set Release Notes 1/29/2021

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]



  

You are subscribed to one or more CDC code sets email subscription services. Subscription links are available on each of the pages below.

 

Code Set Update Publication Date: January 29, 2021 
The individual file names included in this distribution contain the publication date (20210129)

  

  

Release Notes:  This release includes both the Vaccine Code Set Updates and the Vaccine Information Statement (VIS) codes and maps.  


General Note regarding this release:  Codes included with “Last Update” dates January 13 to February 1, 2021 to reflect the changes and additions in this release.  It includes the following code set updates:

A. Vaccine Code Updates

 

1) COVID-19 Potential Pre-EUA Vaccine Code Additions and Updates:

 

COVID-19 Vaccine Codes and Crosswalks for one additional vaccine have been included in this release in anticipation of potential vaccine availability under Emergency Use Authorization (EUA). These codes will become effective if and only when the Food and Drug Administration (FDA) authorizes use of COVID-19 vaccine(s) under an EUA and ACIP votes to recommend the vaccines. The advance release of these codes is intended to help end user organizations prepare their systems ahead of vaccine distribution. 

 

The CVX codes are listed as active.  If EUA authorization and ACIP recommendations are not received, the codes will be inactivated.  The NDC codes are currently listed by the FDA as “unauthorized” and these NDC codes will be activated upon receipt of an EUA authorization. 

 

A separate downloadable table of just COVID-19 codes is also available on the CDC website vaccine code sets page and has been updated to reflect new NDCs for the COVID-19 vaccine and the new CPT codes.
https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html

 

The AMA COVID-19 CPT codes for these potential EUA vaccines are also available and included in the CPT to CVX crosswalk downloadable file.  American Medical Association (AMA) COVID-19 CPT® vaccine product and administration codes are available on the AMA web site:
https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-vaccine-and-immunization-codes


The codes and crosswalks for candidate COVID-19 vaccines will continue to be released in phases as the late-stage clinical trials for candidate vaccines progress.  

 

One potential new EUA candidate vaccine is included in this release as follows:

 

Product Name:  Janssen (J&J) COVID-19 Vaccine:  The CVX Code, CPT Code, and NDC Codes and Product are new in this release

  • CVX Code = 212, CVX Short Description “COVID-19 vaccine, vector-nr, rS-Ad26, PF, 0.5 mL”
  • MVX Code = JSN, “Janssen”
  • NDC Labeler = Janssen Products, LP
  • NDC Unit of Sale:  NDC10 = 59676-580-15, NDC11 = 59676-0580-15; CARTON, 10 MULTI-DOSE VIALS
    • NDC Unit of Use:  NDC10 = 59676-580-05, NDC11 = 59676-0580-05; VIAL, MULTI-DOSE, 2.5mL
  • CPT to CVX Map – CPT Code = 91303 represents specific AMA CPT vaccine product code associated to this vaccine CVX code
  • Product/Tradename = “Janssen COVID-19 Vaccine”

                     

2) NDC Additions and Updates – Not COVID-19 Related:

 

The following NDC pairs were previously retired by FDA with no replacement NDCs – Status changed to active in this release

 

table one as described in text

 

The following NDC Pair has been retired

 

table 2 as described in text

 

B. COVID-19 Special Release VIS Code Set additions

This special release of the CDC VIS Code Set incorporates new preview codes for COVID-19 vaccine Emergency Use Authorization (EUA) Recipient/Caregiver Fact Sheets in anticipation of Emergency Use Authorization (EUA). 

 

CDC Authored VIS documents will not be available for COVID-19 vaccines while under Emergency Use Authorization.  Under EUA, the FDA requires a vaccine-specific Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) be provided to vaccine recipients or their caregivers (similar to Vaccine Information Statements for licensed vaccines). Each EUA Recipient/Caregiver Fact Sheet is developed by the manufacturer and authorized by the FDA. The COVID-19 vaccine related codes in this code set release are provided in anticipation of potential vaccine availability under Emergency Use Authorization.  If the vaccines are not authorized, these codes will be retired. Additional COVID-19 Special Releases with advance preview codes will be provided as other COVID-19 vaccines near their Emergency Use Authorization request submissions to FDA.

 

Release Notes:  This document provides a summary of the Vaccine Information Statement (VIS) code updates and maps included in this COVID-19 Special Release.  


The COVID-19 Vaccines addressed in this release are:

  • Janssen COVID-19 Vaccine
  • AstraZeneca COVID-19 Vaccine

The release includes additions to each of the following code files and tables:

  • CVX Mapped to VIS
  • VIS Barcode Lookup Table
  • VIS to Current URL Table

Important Considerations: 
The CDC is working to facilitate documentation of having provided an EUA Fact Sheet for Recipients and Caregivers (EUA Recipient/Caregiver Fact Sheet) in electronic medical records/immunization information systems.  As such, the VIS code set is being used to provide the EUA Recipient/Caregiver Fact Sheet codes for EHRs/EMRs for use in a manner analogous to the electronic system and workflow documentation of VIS.  As with VIS documents, the COVID-19 Vaccine Recipient/Caregiver Fact Sheets may incorporate the CDC’s scannable 2D barcode in the Fact Sheet document.  The numeric string for a CDC 2D barcode is included for each EUA Fact Sheet record in the data code set for this release.  Each Barcode String includes a unique Global Document Identifier (GDTI) that identifies the vaccine and the specific EUA Recipient/Caregiver Fact Sheet edition date for the document.


The URL document links provided in the VIS to Current URL Table will not be activated until FDA-issued EUA for COVID-19 vaccine with the FDA-authorized EUA Recipient/Caregiver Fact Sheet is available.

 


[Index of Archives]     [NIH News]     [FDA News]     [USDA News]     [Yosemite News]     [Steve's Art]     [SB Lupus]     [STB]
  Powered by Linux