COVID-19 and Regular Vaccine Code Set Release Notes - 5/17/2023

"Centers for Disease Control and Prevention" <no-reply@xxxxxxxxxxxxxxxxxxxx> · Wed, 17 May 2023 14:52:42 -0700

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COVID-19 Vaccine Code  Set Update Publication Date: May  17, 2023 

                      The individual filenames included in  this distribution contain the publication date (20230517)

Release  Notes:  This release includes updates for regular vaccine codes and maps.  It also includes COVID-19 related CVX and NDC  code updates.

Release notes are designed as a guide  to highlight changes that have been made to the vaccine codes since the last  publication.  They should not be used as  the primary source of code information.  The vaccine code files themselves should be  utilized.

General Note Regarding  This Release:  Codes with “Last  Update” dates from 03/17/2023 to 05/16/2023, reflect the changes and additions  in this release.  Summary and detailed  descriptions of the changes are included in the following sections

      Vaccine    Code Set Update Summary
COVID-19    Related Code Updates

On 04/18/2023 the FDA amended the    Emergency Use Authorizations (EUAs) of the Moderna and Pfizer-BioNTech    COVID-19 bivalent mRNA vaccines for ages 6 months and older.  All mRNA COVID-19 vaccine doses are now to    be administered from the currently available bivalent products.  FDA EUA update also rescinded use of the    Pfizer and Moderna EUA monovalent products.   
In this release, three changes have been made in the code    sets related to the above: 
CVX code descriptions for mRNA bivalent vaccine long and    short names have been modified    removing the word booster.   
NDCs for mRNA bivalent vaccine descriptions have been modified removing the word booster.   
The CDC has retired the rescinded EUA authorized monovalent    NDCs for previously active    Pfizer and Moderna vaccines by setting the NDC Unit of Sale and Unit of Use end    dates to 04/18/2023. 
Notes:  
BLA licensed monovalent vaccine NDCs are still technically    licensed and will be retired as manufacturers retire the vaccine NDCs from    the FDA drug file listings.  This may    occur on a rolling basis in future code set publications. 
CVX codes for monovalent mRNA vaccines will be set from a    status of “active” to a status of “inactive” in a later code set release. 
Vaccine    Code Set Updates Not Related to COVID-19
CPT    to CVX Map Correction:  CPT code “Hepatitis    B vaccine (HepB), dialysis or immunosuppressed patient dosage, 4 dose    schedule, for intramuscular use” is now mapped to CVX code 43 “hepatitis B    vaccine, adult dosage”.  It was    previously mapped to CVX code 44.
New NDCs and crosswalks added for MENQUADFI, a meningococcal polysaccharide (groups A, C, Y, W-135) vaccine (manufactured    by Sanofi).  NDCs listed under labeler AS-Medication    Solutions.
NDCs Unit of Sale and Unit of Use retired for    FluMist Medimmune vaccine.
NDC GTINs added for three Units of Sale    and four Units of Use.
NDC end dates were identified and added for historically retired vaccines missing end dates; TWINRIX, and Influenza A    (H5N1) Adjuvanted NDCs.
Other Vaccine Updates:
NDC tradename field for FLUZONE    QUADRIVALENT updated by Sanofi for 9 retired Unit of Sale NDCs and 9 retired    Unit of Use NDCs adding “NORTHERN HEMISPHERE”
Other    last update date changes:  FDA file    changes to fields not published in the CDC code sets have caused date of last    update to be updated in some NDC records.

Vaccine    Code Set Update Details
The core CDC IIS vaccine data code sets    have been updated to reflect the changes in this release.  These can be found at IIS Data Code Sets | CDC.

COVID-19    Related Code Updates

In addition to the FDA’s EUA Fact Sheets    for Recipients/Caregivers, CDC may provide additional or updated clinical    guidance for products under EUA.  See the following link for the latest    CDC COVID-19 vaccine clinical guidance: Clinical Guidance for COVID-19 Vaccination    | CDC
CVX code descriptions for mRNA bivalent vaccine long and    short names have been modified removing    the word booster.  The following codes    have been updated:
      CVX 230 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike    protein, LNP, bivalent, preservative free, 10 mcg/0.2 mL dose” 
CVX 301 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike    protein, LNP, bivalent, preservative free, 10 mcg/0.2 mL dose, tris-sucrose    formulation” 
CVX 302 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike    protein, LNP, bivalent, preservative free, 3 mcg/0.2 mL dose, tris-sucrose    formulation” 
CVX 300 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike    protein, LNP, bivalent, preservative free, 30 mcg/0.3 mL dose, tris-sucrose    formulation” 
CVX 229 “SARS-COV-2 (COVID-19) vaccine, mRNA, spike    protein, LNP, bivalent, preservative free, 50 mcg/0.5 mL or 25 mcg/0.25 mL    dose” 
NDCs for mRNA bivalent vaccine descriptions have been    modified removing the word    booster. The following NDC pair descriptions have been modified:

Sale Proprietary Name Sale      NDC11 Use      NDC11
Moderna COVID-19 Vaccine,      Bivalent 80777-0283-99 80777-0283-02
Moderna COVID-19 Vaccine,      Bivalent 80777-0282-99 80777-0282-05
Pfizer-BioNTech Covid-19 Vaccine,      Bivalent 59267-1404-02 59267-1404-01
Pfizer-BioNTech Covid-19 Vaccine,      Bivalent 59267-0304-02 59267-0304-01
Pfizer-BioNTech Covid-19 Vaccine,      Bivalent 59267-0565-02 59267-0565-01
Pfizer-BioNTech Covid-19 Vaccine,      Bivalent 59267-0609-02 59267-0609-01

The CDC has retired the rescinded EUA authorized monovalent    NDCs for previously active Pfizer and Moderna vaccines by setting the NDC    Unit of Sale and Unit of Use end dates to 04/18/2023.  The    following NDC pairs have been updated: 
Sale Proprietary Name Sale      NDC11 Use      NDC11
Moderna COVID-19 Vaccine 80777-0273-99 80777-0273-10
Moderna COVID-19 Vaccine 80777-0275-99 80777-0275-05
Moderna COVID-19 Vaccine 80777-0273-98 80777-0273-15
Moderna COVID-19 Vaccine 80777-0279-99 80777-0279-05
Pfizer-BioNTech Covid-19 Vaccine 59267-1025-03 59267-1025-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1000-03 59267-1000-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1000-02 59267-1000-01
Pfizer-BioNTech Covid-19 Vaccine 59267-0078-04 59267-0078-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1025-04 59267-1025-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1055-04 59267-1055-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1025-02 59267-1025-01
Pfizer-BioNTech Covid-19 Vaccine 59267-1055-02 59267-1055-01

Vaccine Code Updates Not Related to    COVID-19
CPT to CVX Map Correction:  CPT code 90747 “Hepatitis B vaccine (HepB),    dialysis or immunosuppressed patient dosage, 4 dose schedule, for    intramuscular use” is now mapped to CVX code 43 “hepatitis B vaccine, adult    dosage”.  It was previously mapped to    CVX code 44.  This correctly relates    the CPT code to the 4 dose ENGERIX-B dialysis schedule.  ENGERIX-B NDCs are mapped to CVX code 43.
New NDCs and crosswalks added for    MENQUADFI, a meningococcal polysaccharide (groups A, C, Y, W-135) vaccine    (manufactured by Sanofi).  NDCs listed    under labeler A-S Medication Solutions.

Sale Proprietary Name Sale      Labeler Sale      NDC11 Use      NDC11 CVX      Code CVX      Description MVX      Code Manuf
MENQUADFI A-S      Medication Solutions 50090-6180-00 50090-6180-01 203 meningococcal      conjugate quadrivalent, MenACWY-TT (MCV4) PMC Sanofi
NDCs Unit of Sale and Unit of Use retired for    FluMist Medimmune.  NDC UoS and UoU end    dates set to 03/15/2023.

Sale Proprietary Name Sale      Labeler Sale      NDC11 Use      NDC11
FluMist Quadrivalent MedImmune,      LLC 66019-0309-10 66019-0309-01
NDC GTINs added for three Units of Sale    and four Units of Use.

Sale Proprietary Name Sale Labeler Sale      NDC11 Sale      GTIN Use      NDC11 Use      GTIN
Comirnaty Pfizer Laboratories Div Pfizer      Inc 00069-2025-25 00300692025252 00069-2025-01 10300692025013
Menveo GlaxoSmithKline Biologicals SA 58160-0827-30 00358160827303 58160-0827-03 10358160827034
Rotarix GlaxoSmithKline Biologicals SA 58160-0740-21 00358160740213 58160-0740-02 10358160740029
Comirnaty Pfizer Laboratories Div Pfizer      Inc 00069-2025-10 NA 00069-2025-01 10300692025013
NDC end dates were identified and added for historically retired vaccines missing end dates for TWINRIX, and    Influenza A (H5N1) Adjuvanted NDCs.

Sale Proprietary Name Sale Labeler Sale      NDC11 Sale      End Date Use      NDC11 Use      End Date
Influenza A (H5N1) Monovalent      Vaccine, Adjuvanted GlaxoSmithKline 58160-0808-15 1/18/2018 58160-0804-01 1/18/2018
Influenza A (H5N1) Monovalent Vaccine,      Adjuvanted GlaxoSmithKline 58160-0808-15 1/18/2018 58160-0802-02 1/18/2018
TWINRIX GlaxoSmithKline Biologicals SA 58160-0815-46 2/3/2011 58160-0815-41 2/3/2011
Other Vaccine Updates:NDC tradename field for FLUZONE    QUADRIVALENT updated by Sanofi for 9 retired Unit of Sale NDCs and 9 retired    Unit of Use NDCs adding “NORTHERN HEMISPHERE”.
Other last update date changes:  FDA file changes to fields not published in    the CDC code sets have caused date of last update to be updated in some NDC    records.

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