Immunization Information Systems (IIS) code set updates

["Centers for Disease Control and Prevention (CDC)" <cdc@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Immunization Information Systems (IIS) code set updates

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Links to all of the code sets can be found on the Code Sets web page.

UPDATES:

Overview

The CDC Vaccine Code Sets are being updated as part of an effort to improve the management processes of the vaccine code sets. In this release, the format of each output remains the same, however, there are some updates and changes to the content resulting from the new methods for content sourcing and curation.  The new process includes systematic sourcing of data directly from the data sources of origin to capture the descriptions, data changes, and new additions to those code sets. The systematic sourcing has identified minor errors and discrepancies which are now being corrected.

In this release, there are six categories of changes to the data sets resulting from the transition to the new process and reconciliation of records.

1. Field Value Changes: Some descriptive field values will change slightly to exactly match the originating data from the FDA or AMA. Specific fields affected are described below.
2. Deletion of NDC Codes: Invalid NDC codes, codes that never came to market, or cannot be validated against the FDA files are no longer included in the data set. Associated linkages to CVX and Linker IDs have also been removed.  The deleted NDC codes are enumerated below.
3. Subset Changes of NDC Codes: A few NDC codes were previously incorrectly identified as either a unit of sale or a unit of use. The specific NDC codes affected are detailed below.  These changes resulted in some changes to Linker ID, Inner ID or Outer ID.
4. Completion of NDC Relationships: In previous published data sets, there were a few NDCs where there was a unit of use but no associated unit of sale or a unit of sale with no associated unit of use. In this release, we have addressed the associated by adding the related NDCs to the appropriate subset and reports. Sometimes the NDC Unit of Sale and the linked NDC Unit of Use are the same code. The policy going forward is that there should be no “orphans” and every vaccine should have at least one unit of sale and at least one unit of use associated to that unit of sale. This will provide a more consistent data set.
5. Consistent Population of NDCs Across Reports: In prior releases, the Lookup table and NDC Linker table displayed NDC codes not included on the Unit of Use or Unit of Sale tables. The NDC codes included on the Lookup and NDC Linker tables will now be included on the Unit of Sale and Unit of Use reports. For this release, this means a few additional NDCs will appear on the Unit of Sale and Unit of Use reports than had been reported previously only through the Lookup or the NDC Linker report.  
6. Report Capitalization Changes: The data conversion process resulted in minor changes to the text case for some fields, either as a change to the capitalization of the field header or the field value.  Examples: For the CPT Mapped to CVX file, the field header “CPT_CODE” is now “CPT_Code”; on the CVX Code file, the field values for field “nonvaccine” were “TRUE” or “FALSE” and are now “True” or “False.”

Detailed Changes

1. Field Value Changes: Code and description fields are now directly populated from published source files. In the past, this information was captured and curated manually, sometimes modifying the original information. As a result, the following fields may have slight variations in the exact content value, text case or punctuation:
   1. NDC Unit of Sale:
      1. OuterPropName/Sale Proprietary Name (this is the tradename) will now be provided exactly as it appears on source files
         Examples include:
         • NDC (58160-0808-15) was “INFLUENZA (H5N1), adjuvanted” on CDC prior file, is now “Influenza A (H5N1) Monovalent Vaccine, Adjuvanted”
         • NDC (63851-0613-01) was Flucelvax, is now FLUCELVAX
      2. OuterLabelerName (the labeler company name listed on the product label) will now be provided exactly as it appears on the FDA’s NDC files for that product. Note: A product will show the last labeler for that NDC while the product was active.
         • Example: (NDC 00006-4963-41) was “Merck” on CDC prior file, is now “Merck Sharp & Dohme Corp.”
   2. NDC Unit of Use:
      1. UseUnitPropName (this is the tradename) will now be provided exactly as it appears on the FDA’s NDC files
         Examples include:
         • NDC (46028-0218-11) was “Meningococcal (Groups A) CRM197 Oligosaccharide Co” on CDC prior file, is now “Menveo”
         • NDC (49281-0517-00) was “Fluzone Quadrivalent, pediatric” on CDC prior file, is now simply “FLUZONE QUADRIVALENT”. Since the CDC will no longer make changes to the tradename, if a distinction exists between an NDC for pediatric versus an NDC for adult or general dosage/form, this should be addressed through the NDC to CVX mapping. In this example, it was already differentiated as follows:
           • CVX code 161 - Influenza, injectable, quadrivalent, preservative free, pediatric
           • CVX code 150 - influenza, injectable, quadrivalent, preservative free
      2. UseUnitLabelerName (this is the labeler company name listed on the product label) will now be provided exactly as it appears on the last published FDA NDC file for this product).
         • Example: NDC (00005-0100-01) was “Pfizer”, is now “Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc.”
   3. NDC Lookup:
      1. Sale Proprietary Name (this is the tradename) will now be provided exactly as it appears on the FDA’s NDC files
         Examples include:
         • NDC (58160-0808-15) was “INFLUENZA (H5N1), adjuvanted” on CDC prior file, is now “Influenza A (H5N1) Monovalent Vaccine, Adjuvanted”
         • NDC (63851-0613-01) was Flucelvax, is now FLUCELVAX
      2. Sale Labeler (the labeler company name listed on the product label) will now be provided exactly as it appears on the FDA’s NDC files for that product. Note: A product will show the last labeler for that NDC while the product was active.
         • Example: (NDC 00006-4963-41) was “Merck” on CDC prior file, is now “Merck Sharp & Dohme Corp.”
   4. CPT Procedure Codes:
      1. CPT_description will now be provided exactly as it appears on the AMA’s published CPT files. It should be noted that the AMA periodically amends the description of an existing CPT code. The prior manual process to capture code descriptions missed some of these updates.
         • Example: (CPT 90649) description was “Human Papilloma virus (HPV) vaccine, types 6, 11, 16, 18 (quadrivalent) 3 dose schedule, for intramuscular use” on the prior CDC file, is now “Human Papillomavirus vaccine, types 6, 11, 16, 18, quadrivalent (4vHPV), 3 dose schedule, for intramuscular use”

2. Deletion of NDC Codes

   The following historic NDC Codes could not be validated against FDA data files or DailyMed archives. They are either invalid codes or never came to market. They are not included in this release.

   Table for Deleted NDCs (unit of sale or use)

   CDC Unit of Sale Deleted NDCs	42874-0116-10 70460-0002-01 70461-0200-02 70461-0614-01
   CDC Unit of Use Deleted NDCs	42874-0116-01 70461-0200-12 49281-0913-58 70461-0119-02 70461-0614-11

3. Subset (Unit of Use or Unit of Sale) Changes to existing NDC Codes
   The following NDCs were found to be incorrectly described as either a unit of use or unit of sale. They have been added to the correct subset and removed from the previously published subset.  Note that new inner or outer IDs (used in the NDC Linker table) have been assigned to some of the NDCs to reflect the change.

   Table for changes to existing NDC codes

   NDC Code/Description	Unit of Sale	Unit of Use
   66019-0303-01	Removed from	Added to
   66019-0303-10	Added to	Removed from
   70461-0119-10	Added to	Removed from
   70461-0119-11	Removed from	Added to
   70461-0119-02	Added to	Removed from
   70461-0119-12	Removed from	Added to
   66521-117-02	Added to	Removed from
   66521-117-12	Removed from	Added to

4. Completion and additions to records and linkages between NDC records
   Some NDC record generic descriptions have been updated or populated where previously missing.  In addition, the following records associations have been completed or corrected.

   Table for changes to NDC record completions, additions, and associations

   NDC Code	Unit of Sale	Unit of Use	Other Updates, Comments to complete records
   58160-0828-03		New-Added Missing UoU. Associated to UoS 58160-0823-11	SHINGRIX, New Linker ID, New Inner ID, mapped to CVX 187 (Zoster Vaccine Recombinant) and MVX code SKB
   49281-0913-01		New-Added 49281-0913-01 as a UoU, associated to same number NDC UoS.  Note previously associated UoU 49281-913-58 was deleted as an invalid NDC (#2 above)	STAMARIL, Packaged as single dose kits. New Linker ID, Inner ID, mapped to CVX 183 and MVX code PMC
   42515-002-01		New-Added 42515-002-01 as a UoU associated to same number NDC UoS.	IXIARO, packaged as single dose.  New Linker ID, Inner ID, mapped to CVX 134 and MVX code VAL

5. Consistent Population Across reports

   The following NDCs have been added to the Unit of Sale or Unit of Use files. These NDCs are valid and were previously reported on the website NDC Crosswalk table, or the NDC Linker file, but not reflected in the Unit of Sale or Unit of Use files.

   Table for NDCs added to unit of sale or use files

   Added to Unit of Sale File	Added to Unit of Use File
   21695-0413-01 76420-0482-01 76420-483-01 00006-4133-41 54868-2219-00 54868-6180-00 54868-2219-01 54868-6177-00	70461-0614-01 54868-2219-00 54868-2219-01 54868-6177-00 76420-0470-10 76420-0471-01

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