Immunization Information Systems (IIS) Code Set Release Note

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Title: Immunization Information Systems (IIS) Code Set Release Note

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Release Note (3/12/2019)

1) A new CVX code has been created for a non-US vaccine:

  • 194 – Influenza, Southern Hemisphere, unspecified formulation
  • This CVX code has been assigned to the vaccine group “FLU”

2) A new vaccine product has been added: Vaxelis™ manufactured by Sanofi and packaged/labeled by MCM Vaccine Co. The new vaccine is for DTaP-IPV-Hib-HepB dose for 4 wks to 4 yrs. It is generically described as “Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine”. The following updates to the code set have been made:

  • Two new VAXELIS NDCs have been added to the crosswalk, Unit of Use, Unit of Sale and Linker value sets. Note that the NDC Labeler ID is for is MCM Vaccine Co, but the manufacturer is Sanofi Pasteur, MVX “PMC”. The new NDCs are:
    • Unit of Use NDC 63361-245-58 / Unit of Sale NDC 63361-245-10
  • The status for CVX Code 146 “DTaP-IPV-Hib-HepB“ has been changed from Pending to Active. The new NDCs are mapped to this CVX code
  • New product record “VAXELIS“ has been added and is associated to Sanofi Pasteur MVX (PMC) as the manufacturer
  • Also note that the next release of the CVX to VIS mapping file (not included with this release) will update the VIS associations for CVX code 146

3) A change has been made to the CPT to CVX mapping for CPT Code 90747 “Hepatitis B vaccine (HepB), dialysis or immunosuppressed patient dosage, 4 dose schedule, for intramuscular use” from CVX Code 43 "Hep B, adult" to CVX Code 44 "Hep B, dialysis". This reverses an earlier mapping change that was made to align the NDC codes for Engerix-B and CPT code 90747 to the same CVX. The NDCs for Engerix-B continue to be mapped to CVX code 43 which is not specific to dialysis use. CPT code 90747 is now correctly mapped to the more specific CVX code 44.

4) Sanofi Pasteur acquired Protein Sciences in August 2017. The currently active NDCs (below) for Flublok quadrivalent have been updated to correctly map to Sanofi Pasteur MVX “PMC” instead of Protein Science MVX “PSC”. Inactive older NDCs remain with their original association to PSC. Notations about the acquisition have been made to the MVX records for both PMC and PSC. To correctly reflect the history, a new record has also been added to the product file to associate Flublok quadrivalent to the MVX for PMC. Following is the active NDC pairing affected by this change:

  • Unit of Use NDC 49281-718-88 / Unit of Sale NDC 49281-718-10 for Flublok quadrivalent

5) Updates to GTINs for NDC Units of Use have been made on the NDC Crosswalk table and the Unit of Use download file. GTINs are only added to NDC Unit of Use vaccines if the vaccine is 2D barcoded. GlaxoSmithKline has provided changes for 29 GTINs (1 GTIN removal, 28 changed GTINs), and Dynavax has provided a correction to one GTIN.


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