Representing Immunizations

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	Clinical Vaccines Administered (CVX)	Final	Production		Yes	Free	N/A
Standard	National Drug Code (NDC)	Final	Production		Yes	Free	N/A
Standard	Manufacturing Vaccine Formulation (MVX)	Final	Production		No	Free	N/A
Standard	Current Procedural Terminology (CPT®)	Final	Production		No	$	No
Standard	RxNorm	Final	Production	Feedback Requested	No	Free	N/A

Limitations, Dependencies, and Preconditions for Consideration	Applicable Value Set(s) and Starter Set(s)
General considerations: The list above includes any vocabulary used to record immunizations in any health IT system including IIS, pharmacy, billing, etc. NDC has been used by pharmacies to report historical doses for billing purposes, so it is included here in that context. The CDC's National Center for Immunization and Respiratory Diseases (NCIRD) developed and maintains the CVX and MVX code systems, and developed and maintains the NDC vaccine tables based on information published by the FDA. RxNorm is an acceptable alternative code set for use at the local level. RxNorm is not utilized for reporting of previous dispensing. For Immunization Information System (IIS) consideration: The CDC's National Center for Immunization and Respiratory Diseases (NCIRD) developed and maintains the CVX and MVX code systems, and developed and maintains the NDC vaccine tables based on information published by the FDA. CVX codes are designed to represent administered and historical immunizations and will not contain manufacturer-specific information. If an MVX code is paired with a CVX (vaccine administered) code, the specific trade named vaccine may be indicated providing further specificity as to the vaccines administered. There is a potential issue with use of the National Drug Code regarding which code to use when there are multiple active ingredients in a single package or multiple separate ingredients that need to be mixed together. CDC has published guidance on NDC Unit of Use and Unit of Sale; it can be found at: https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf. The lot number is used in conjunction with the NDC when reporting immunizations to IIS. There is no standard codification for lot numbers. The IIS community does not utilize RxNorm as a code set and thus it may have limitations for interoperability across systems.	CVX: Vaccines Administered MVX: entire code set NDC concepts used to represent vaccines

Limitations, Dependencies, and Preconditions for Consideration

Applicable Value Set(s) and Starter Set(s)

General considerations:

The list above includes any vocabulary used to record immunizations in any health IT system including IIS, pharmacy, billing, etc.
NDC has been used by pharmacies to report historical doses for billing purposes, so it is included here in that context.
The CDC's National Center for Immunization and Respiratory Diseases (NCIRD) developed and maintains the CVX and MVX code systems, and developed and maintains the NDC vaccine tables based on information published by the FDA.
RxNorm is an acceptable alternative code set for use at the local level.
RxNorm is not utilized for reporting of previous dispensing.

For Immunization Information System (IIS) consideration:

The CDC's National Center for Immunization and Respiratory Diseases (NCIRD) developed and maintains the CVX and MVX code systems, and developed and maintains the NDC vaccine tables based on information published by the FDA.
CVX codes are designed to represent administered and historical immunizations and will not contain manufacturer-specific information.
If an MVX code is paired with a CVX (vaccine administered) code, the specific trade named vaccine may be indicated providing further specificity as to the vaccines administered.
There is a potential issue with use of the National Drug Code regarding which code to use when there are multiple active ingredients in a single package or multiple separate ingredients that need to be mixed together. CDC has published guidance on NDC Unit of Use and Unit of Sale; it can be found at: https://www.cdc.gov/vaccines/programs/iis/2d-barcodes/downloads/guidance-documenting-ndc.pdf.
The lot number is used in conjunction with the NDC when reporting immunizations to IIS. There is no standard codification for lot numbers.
The IIS community does not utilize RxNorm as a code set and thus it may have limitations for interoperability across systems.

Comment

Submitted by mbkurilo@immre… on 2023-10-06

Representing Immunizations

The American Immunization Registry Association (AIRA) appreciates the structure and organization of this section. We do have one formatting recommendation; both “Immunization Information System (IIS)” and “State Registry” are used above and throughout the ISA to refer to IIS. We prefer the term Immunization Information System as it is more inclusive of the broad functionality encompassed within these systems. Additionally, some IIS are operated at the city level, rather than the state level, so state registry would be better referred to as jurisdictional IIS.

Submitted by mbkurilo@immre… on 2022-05-06

AIRA Comments - Administered and Historical Immunizations

The "Representing Immunizations - Historical" page is very similar to the administered page. It includes the same 5 code sets and mostly the same considerations (in blue). AIRA proposes these be consolidated into a single page and deal with the nuanced differences in the blue Considerations section rather than retain and maintain two nearly identical pages.

Submitted by pwilson@ncpdp.org on 2021-09-29

NCPDP Comments

RxNorm – is not utilized for reporting of previous dispensing.

Submitted by pwilson@ncpdp.org on 2020-11-07

NCPDP Comment

NCPDP supports ONC’s recommendations.

Submitted by gldickinson on 2020-10-23

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements

Resolving to myriad de-coupled fragments
With vanishingly little focus on:
- Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
- Elements and context + purpose of capture: e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...

It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI. The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user. Only the source EHR/HIT system can structure clinical content and context properly. Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

Submitted by mattreid on 2019-10-08

The American Medical…

The American Medical Association requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Immunizations - Historical. The CPT code set is identified as a terminology standard for Representing Immunizations – Administered, so therefore, it should be included as a standard for historical immunizations. CPT was created over 50 years ago and is a uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

Submitted by pwilson@ncpdp.org on 2019-09-23

NCPDP Comment

Request ONC to add NDC as a value. NDC has historically been used by pharmacy to report immunizations.
Add the following:

Type-Implementation Specification

Standard Implementation/Specification- National Drug Code

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 5

Federally Required – Yes

Cost – Free

Test Tool Availability – N/A

Submitted by mbkurilo@immre… on 2018-10-01

Comments on Immunization Topics

Thank you for the opportunity to comment on these and other immunization topics related to the ISA. Our member feedback from the American Immunization Registry Association is attached.

AIRA Letter and Comments - ONC 2018 Standards Advisory - Oct 2018.pdf

Submitted by cmcdonald on 2018-10-01