Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Data Element
Medication Administered Code
Description

A code (or set of codes) that specify the medication that was administered.
Submitted By: Maria Michaels / CDC
Data Element Information
Data Element Description A code (or set of codes) that specify the medication that was administered.
Rationale for Separate Consideration USCDI data element is "Medication". In FHIR US Core, there is a distinction between "Medication" and "Medication Request"; base FHIR has "Medication Administration". Both concepts, prescribed and administered, should be explicitly included in USCDI.
Use Case Description(s)
Use Case Description Actively monitoring diseases, making decisions about public health threats, identifying trends in healthcare services utilization and other public health matters depend on accessible and accurate data. EHRs are a data source that can provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to more rapid disease detection, tracking, and treatment and innovation in healthcare delivery.

Medication information, including the date the medication is prescribed or administered, coded identification, and dosage of the medication prescribed or administered are important to multiple public health reporting and research use cases to track and analyze information about treatment for various health conditions. The reason code for the medication provides information to identify which particular condition the medication was used to treat.

The Making EHR Data More Available for Research and Public Health (MedMorph) project's goal is to create a reliable, scalable, and interoperable method to get electronic health record data for multiple public health and research scenarios (use cases). MedMorph has identified Cancer Registry Reporting, Healthcare Surveys, Electronic Initial Case Reporting (eCR), Hepatitis C Reporting, and Research (PCORnet) use cases that support the adoption of some or all of these data elements. These specific use cases are described in more depth on their respective web pages.
Estimate the breadth of applicability of the use case(s) for this data element All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.

All hospitals and physicians who diagnose or treat cancer are required to provide cancer related medication (treatment) information to state cancer registries.

Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. 

There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here.

Supporting Links:
MedMorph: https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html

Cancer Reporting: https://www.cdc.gov/cancer/npcr/

Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf

Health Care Survey: https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm

eCR: https://www.cdc.gov/ecr/index.html

PCORnet: https://pcornet.org/
Link to use case project page https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html Cancer Reporting: https://www.cdc.gov/cancer/npcr/ Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf
Supporting Attachments MedMorph-HealthCareSurveyReportingUseCase-DRAFT.pdf
MedMorph-CancerReportingUseCase-DRAFT.pdf
MedMorph-ChronicHepatitisCSurveillanceUseCase-DRAFT.pdf
Use Case Description A foundational goal of MedMorph is generalizability beyond the 10 use cases that are actively informing the MedMorph project, in order to support many more public health and research use cases. Therefore, other public health and research use cases that use the MedMorph architecture will also benefit from adoption of these data elements.
Estimate the breadth of applicability of the use case(s) for this data element All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.

All hospitals and physicians who diagnose or treat cancer are required to provide cancer related medication (treatment) information to state cancer registries.

Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. 

There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here.
Use Case Description Birth reporting use case: Healthcare facilities are required to report to state vital records offices if antibiotics were administered under two circumstances: 1) for the mom during labor and delivery and 2) for the newborn for suspected neonatal sepsis. At the point of clinical care these elements identify suspected neonatal sepsis of the newborn and if the mother received antibiotics during labor. These medications must be properly identify, and if they were administered in order to complete facility worksheets and birth certification. It is required to report the administration of these medications to the State VROs electronic birth registration systems (EBRS), and to the National Vital Statistics System (NVSS). This medical information is collected within the Facility Worksheet for the Live Birth Certificate (cdc.gov), and reported within the US Standard Certificate of Live Birth for national level reporting. At the population level the state VROs and the NVSS provide aggregate data on births and risk factors that may impact the mother or newborn during labor and delivery and throughout life.
Use Case Description The CDC has requested that ONC adds the following Use case in support of this data element being added to USCDI:

"Medication Opioids": Unintentional injuries are the leading cause of death for Americans aged 1–44 years. The leading cause of death for unintentional injury is poisoning, specifically drug overdose. Overdose deaths continue to climb each year and accelerated during the COVID-19 pandemic. The majority of national overdose deaths involve opioids. Many patients receive their first exposure to opioids following surgery, and dentists are the leading prescriber of opioids among adolescents aged 10-19 and second-leading prescriber among young adults aged 20–29. In 2004, an estimated 3.5 million patients had wisdom teeth extracted. Filled opioid prescriptions after wisdom tooth extraction is associated with higher odds of persistent opioid use among opioid-naïve patients. Better understanding prescribing habits can help identify risk factors and particularly vulnerable populations.
"Medications Antibiotics": More than 2.8 million antimicrobial-resistant infections occur in the United States each year, and more than 35,000 people die as a result. When Clostridioides difficile is added to these, the US toll exceeds 3 million infections and 48,000 deaths. The threat of antibiotic resistance undermines progress in health care, food production, and life expectancy. Addressing this threat requires preventing infections in the first place, slowing the development of resistance through better antibiotic use, and stopping the spread of resistance when it develops. Research shows that dentists overuse antibiotics, particularly for patients who are underinsured. Dentists prescribe 10% of all outpatient antibiotics, although there is significant geographical variability. Better understanding prescribing practices, knowledge, and beliefs can aid in the development of meaningful antimicrobial stewardship efforts addressing case selection and areas of practice.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Date Medication Prescribed and Date Medication Administered: dateTime Data Type (FHIR): http://hl7.org/fhir/datatypes.html#dateTime

Medication Prescribed Code and Medication Administered Code: RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html

Medication Prescribed Dose Units and Medication Administration Dose Units: UCUM: http://unitsofmeasure.org
http://hl7.org/fhir/datatypes.html#dateTime https://www.nlm.nih.gov/research/umls/rxnorm/index.html http://unitsofmeasure.org
Additional Specifications HL7 CDA ® Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398. SHALL for the following elements: Date Medication Administered, Medication Administered Code, Medication Administered Reason Reference, Medication Administration Dose.
SHOULD for the following elements: Medication Administration Dose Units

HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385

HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492). SHALL for the following elements: Date Medication Administered, Medication Administered Code, Medication Administered Reason Reference, Medication Administration Dose. SHOULD for the following elements: Medication Administration Dose Units

HL7 FHIR® US Core Implementation Guide STU3 Release 3.1.1 (https://www.hl7.org/fhir/us/core/index.html)

HL7 FHIR US Core Medication Request (http://hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html). MustSupport for the following elements: Medication Prescribed Code, Medication Prescribed Dose, Medication Prescribed Dose Units

HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm (http://hl7.org/fhir/us/ecr/STU1/Electronic_Initial_Case_Report_(eICR)_Transaction_and_Profiles.html)

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436)
Current Use Extensively used in production environments
Supporting Artifacts Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems.

Widely available in EHR systems.

These data elements exist in FHIR with a FHIR Maturity level of 2 for MedicationAdministration and 3 for MedicationRequest. FHIR MedicationAdministration: http://hl7.org/fhir/medicationadministration.html. FHIR MedicationRequest: http://hl7.org/fhir/medicationrequest.html.

ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies: https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies.

Part of Core EHR Certification since at least 2014.
Specified in Meaningful Use/Promoting Interoperability since Stage 1.
Part of EHR Certification for Transmission to Cancer Registries (2015 and 2014 Editions).

Promoting Interoperability Programs Eligible Hospitals and Critical Access Hospitals are required to, and Merit-based Incentive Payment System (MIPS) participants may optionally, report on any two measures under the Public Health and Clinical Data Exchange objective of these programs. The § 170.315(f)(5) – Transmission to public health agencies – electronic case reporting certification criteria in the 2015 Edition Final Rule and the ONC Cures Act Final Rule, the § 170.315(f)(7) – Transmission to public health agencies – health care surveys, and the § 170.315 (f)(4) – Transmission to Cancer Registries are three such options to meet these measures.

The current standard for § 170.315(f)(5), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: Public Health Case Report, Release 2: the Electronic Initial Case Report (eICR), Release 1, STU Release 1.1. ONC’s Certified Health IT Product List (CHPL) lists 73 EHR or HIT Module products certified to (f)(5) using this standard. eCR IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436.

The current standard for § 170.315(f)(7), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 116 EHR or HIT Module products certified to (f)(5) using this standard. NHCS IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385.

The current standard for § 170.315 (f)(4), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7 CDA® R2 IG: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, R1, DSTU Release 1.1 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 288 EHR or HIT Module products certified to (f)(4) using this standard. Cancer Reporting IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398.

These three widely adopted CDA standards have many of the Medication data elements contained on this form as Shall (required) or Should (best practice to include if available) conformance criteria, which demonstrates the maturity of these commonly exchanged data elements.                         

Supporting Links:
EPIC Medication Request API: https://fhir.epic.com/Specifications?api=996

Cerner Medication Request API: https://fhir.cerner.com/millennium/r4/medications/medication-request/

Allscripts API: https://developer.allscripts.com/FHIR?PageTitle=Resources

Evident API: https://api.evident.com/dstu2/medication-order

Cancer Test Procedures: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure

2014 Edition Test Methods: https://www.healthit.gov/sites/default/files/2014_test_methods/2014_edition_test_methods_archived.zip
http://hl7.org/fhir/medicationadministration.html FHIR MedicationRequest: http://hl7.org/fhir/medicationrequest.html EPIC Medication Request API: https://fhir.epic.com/Specifications?api=996
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Level 2 – exchanged between 4 or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to the next draft version.

At least 38 state cancer registries have received cancer reports from at least one provider (per internal technical and programmatic documentation) that include these data elements: Date Medication Prescribed, Medication Prescribed Code, Medication Prescribed Dose, Medication Prescribed Dose Units, Date Medication Administered, Medication Administered Code, Medication Administration Dose, and Medication Administration Dose Units.

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) - the Electronic Initial Case Report (eICR) is currently implemented in 5,400+ reporting sites nationally and exchanges all the Medication described in this submission.

As part of Cancer Reporting CDA IGs:
IHE Connectathons 2010-2020
HIMSS Interoperability Showcase 2010-19
Public Health Informatics Conference Interoperability Showcase 2014, 2016, 2018
NACCHO 360X Interoperability Demonstrations, 2020

As part of National Health Care Surveys CDA IGs:
IHE Connectathons 2019-2020

ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies: https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies.

Supporting Links:
https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries
Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information
Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries)

IHE Connectathon: https://connectathon-results.ihe.net/
https://chpl.healthit.gov/#/search
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden Low.

All providers need to capture medication prescription and administration information as a basic component of patient care.

Several existing IGs, as listed, require the exchange of this data element. The Promoting Interoperability Programs Objective 8 - Public Health and Clinical Data Registry Reporting, Measures 1: Immunization Registry Reporting, 2: Syndromic Surveillance Reporting, 3: Electronic Case Reporting and 4: Public Health Registry Reporting all require these data elements.

This information is routinely communicated in HL7 CDA Documents and some FHIR API transactions.
Other Implementation Challenges None
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is a specialized use or subset of an existing data element Medication, in the Medications data class in USCDI v4

Comment

Submitted by BLampkins_CSTE on

Medication Administered Code - CSTE Comment

Medication data are critical for exchange with public health and is included in eCR standards. They are particularly important for STI programs, HIV and TB surveillance, as well as for public health response and surveillance for antimicrobial resistant pathogen infections. The ability to exchange data on prescribing of opioid medications in particular is of great importance to public health programs which aim to reduce opioid overdoses and deaths.

Submitted by CDC_DSMH_WG on

CDC's support for CMS comment for USCDI v7

CDC supports CMS CCSQ recommendation for Date Medication Administered (Level 0), Medication Administered Code (Level 0), Medication Administration Dose (Level 0), and Medication Administered Reason Reference (Level 0) these elements be advanced to Level 2 and added to final USCDI v7.

Submitted by rdillaire on

CMS-CCSQ Supports Medication Administered Code for USCDI v7

Recommendation:  CMS CCSQ recommends Date Medication Administered, Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference be advanced to Level 2 and added to final USCDI v7.

Rationale:  CMS CCSQ, CDC, and the Council of State and Territorial Epidemiologists (CSTE) requests the inclusion of the Date Medication Administered (Level 0), Medication Administered Code (Level 0), Medication Administration Dose (Level 0), and Medication Administered Reason Reference (Level 0) data elements in USCDI to fill critical gaps in patient safety and care quality. Medication Administration data elements are also supported by RxNorm and are currently collected and exchanged by at least one national EHR vendor. 

Medication administration remains a key priority for CMS and CDC programs as it is essential for quality improvement and public health surveillance. Moving these data elements to USCDI v7 would support access to critical information to care providers. These data elements are important for medication reconciliation and continuity of care, especially during transitions of care between acute and post-acute settings. Existing Medications class data elements in USCDI record when a medication has been ordered or dispensed, but they do not reflect the data associated with the actual administration of the medication to the patient. These medication administration data elements are critical for providing this clarification. Including Medication Administration data elements in USCDI v7 would also facilitate documentation and use of medication related data already being collected in health care settings, including on the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) (CMS IRF-PAI Manual Version 42; Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) and IRF-PAI Manual), the Minimum Data Set (MDS) (Long-Term Care Facility (LTCF) Resident Assessment Instrument (RAI) 3.0 User Manual Version 1.19.1;  MDS 3.0 RAI Manual), OASIS (OASIS User Manuals), and Long-Term Care Hospital (LTCH) Continuity Assessment Record and Evaluation (CARE) (LTCH CARE Data Set (LCDS) & LCDS Manual). Additionally, as shown in this crosswalk of QI-Core, US Core and FHIR resources, there is currently a gap in US Core with the exclusion of Medication Administration data elements which could be addressed by their inclusion in USCDI v7. 

Several technical and practical considerations also support this recommendation:

  1. The Medication Administered Code data element is represented in both the PACIO Standard Medication Profile (SMP) IG and the Vulcan Real World Data (RWD) IG. It can be captured, stored, and exchanged electronically in all EHRs, supporting use cases like prior authorization application programming interfaces (APIs) and provider-payer APIs. This data element applies across all healthcare settings and diagnoses.
  2. The Medication Administered Dose data element is similarly represented in the PACIO SMP IG and the HL7 Clinical Document Architecture (CDA) IG.

Applicable standards: 

  1. Date Medication Prescribed and Date Medication Administered: dateTime Data Type (FHIR; 2.1.28.0 Datatypes).
  2. Time Medication Prescribed Code and Medication Administered Code: RxNorm (National Library of Medicine (NLM) Unified Medical Language System (UMLS) RxNorm).
  3. Medication Prescribed Dose Units and Medication Administration Dose Units: Unified Code for Units of Measure (UCUM).

Together, these data elements fill essential gaps in medication reconciliation, facilitate smoother care transitions, and contribute to better patient outcomes through improved medication administration tracking and coordination across care settings.

Submitted by rdillaire on

CMS-CCSQ Supports Medication Administered Code for USCDI v6

Recommendation: CMS CCSQ recommends the Date Medication Administered, Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference data elements be advanced to Level 2 and added to final USCDI v6.

Rationale: CMS CCSQ, CDC, and the Council of State and Territorial Epidemiologists (CSTE) requests the inclusion of the Date Medication Administered (Level 0), Medication Administered Code (Level 0), Medication Administration Dose (Level 0), and Medication Administered Reason Reference (Level 0) data elements in USCDI to fill critical gaps in patient safety and care quality. Medication administration remains a key priority for CMS and CDC programs as it’s essential for quality improvement and public health surveillance. Moving these data elements to USCDI v6 would support access to critical information to care providers. These data elements are important for medication reconciliation and continuity of care especially during transitions of care between acute and post-acute settings. Existing Medications Class data elements in USCDI record when a medication has been ordered or dispensed, but they do not reflect the data associated with the actual administration of the medication to the patient. These medication administration data elements are critical for providing this clarification. They are also supported by RxNorm. Including Medication Administration data elements in USCDI v6 would also facilitate documentation and use of medication related data already being collected in health care settings, including on the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) (CMS IRF-PAI Manual Version 42; Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) and IRF-PAI Manual), the Minimum Data Set (MDS) (Long-Term Care Facility (LTCF) Resident Assessment Instrument (RAI) 3.0 User Manual Version 1.19.1;  MDS 3.0 RAI Manual), OASIS (OASIS User Manuals), and Long-Term Care Hospital (LTCH) Continuity Assessment Record and Evaluation (CARE) (LTCH CARE Data Set (LCDS) & LCDS Manual).

Several technical and practical considerations also support this recommendation:

    i. The Medication Administered Code data element is represented in both the PACIO Standard Medication Profile (SMP) IG and the Vulcan Real World Data (RWD) IG. It can be captured, stored, and exchanged electronically in all EHRs, supporting use cases like prior authorization application programming interfaces (APIs) and provider-payer APIs. This data element applies across all healthcare settings and diagnoses.

    ii. The Medication Administered Dose data element is similarly represented in the PACIO SMP IG and the HL7 Clinical Document Architecture (CDA) IG.

Applicable standards: 

    i. Date Medication Prescribed and Date Medication Administered: dateTime Data Type

    ii. Time Medication Prescribed Code and Medication Administered Code: RxNorm

    iii. Medication Prescribed Dose Units and Medication Administration Dose Units: Unified Code for Units of Measure

Together, these data elements fill essential gaps in medication reconciliation, facilitate smoother care transitions, and contribute to better patient outcomes through improved medication administration tracking and coordination across care settings.

Submitted by BLampkins_CSTE on

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

Submitted by gsgordon on

This must be included in USCDI

  • This MUST finally be included in USCDI.  Multiple agencies have made a STRONG case for this. Continued lack of inclusion in USCDI is difficult to comprehend as at is a basic healthcare component used widely around the globe.  Additionally, relegation all the way to Level 0 contradicts all fact:
  •  
  • Not represented by a terminology standard or SDO-balloted technical specification or implementation guide:  FALSE: Represented by many FHIR IG's including Vulcan RWD IG (https://build.fhir.org/ig/HL7/vulcan-rwd/) , AU Base Medication Administration - AU Base Implementation Guide v4.2.2-ci-build (fhir.org), Home - Epic on FHIR, etc)
  • In the Vulcan RWD IG, the IG does not ask for very much, but it does expect Administered Medication to be standardized in HL7 FHIR.  The minimum the RWD IG requires is 
  • ... status        code    in-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
    ... medication[x]    CodeableConcept, Reference(Medication)    What was administered
    ... subject    S    1..1        Who received medication
    ... effective[x]    dateTime, Period    Start and end time of administration
  • Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
  • Data element is electronically exchanged in limited environments, such as connectathons or pilots: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
  • Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
  •  
  •  
  • Level 2 at minimum is more accurate, and it used to be in Level 2.  And it really should be part of USCDI
  • Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
  • Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
  • Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
  • Use cases apply to most care settings or specialties.

Submitted by BLampkins_CSTE on

CSTE Comment - v5

Medication data is critical for exchange with public health and is included in eCR standards. It is especially important for STI programs, HIV and TB surveillance as well as for public health response and surveillance for antimicrobial resistant pathogen infections.   CSTE also strongly agrees that the ability to exchange data on prescribing of opioid medications in particular is of great importance to public health programs which aim to reduce opioid overdoses and deaths.

Submitted by CDC_DSMH_WG on

CDC's Comment for draft USCDI v5

CDC-CMS Joint Priority Data Element. 

See letter here (submitted on 1/29/2024): https://www.healthit.gov/isa/sites/isa/files/2024-02/FINAL_CDC%20and%20CMS-CCSQ%20Joint%20USCDI%20v5%20submission%20letter_012924.pdf

Submitted by yale-coredQMRoadmap on

CDC and CMS-CCSQ Joint Support for Medication Admin. Code

Thank you for opportunity to comment on this data element. The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) emphasize the importance of patient safety being reflected in the USCDI standards. As an integral aspect of patient safety, medication management is critical to patient care and coordination between providers, and related quality and public health enterprises. Medication administration, specifically, is a critical concept for CMS and CDC programs that support quality improvement and public health surveillance. We continue to emphasize the need for greater specificity in the USCDI Medications data class. The medications data class in USCDI is currently inadequate to support patient safety, quality improvement, or public health. The medication data elements do not differentiate among medications that are active, ordered, and administered/prescribed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care and promote patient safety. CMS and CDC strongly recommend the Medication Administration (Level 2)/Medication Administered Code (Level 0) in the Medications data class be added to USCDI.

Submitted by CDC_DSMH_WG on

CDC's comment on behalf of CSTE for USCDI v5

  • CSTE strongly agrees with CDC.
  • Medication data is critical for exchange with public health and is included in eCR standards. It is especially important for STI programs, HIV and TB surveillance as well as for public health response and surveillance for antimicrobial resistant pathogen infections.   CSTE also strongly agrees that the ability to exchange data on prescribing of opioid medications in particular is of great importance to public health programs which aim to reduce opioid overdoses and deaths.

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The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.

If you are only commenting on a single data class or element, you may leave this field blank.

2. Select the Data Class

To specify which data class your comment addresses:

  1. In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
  2. If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
  3. Note that the Data Class field will automatically populate based on your current location in the platform:
    1. If you are on a data class page, the field will be set to that specific data class
    2. If you are on a data element page, the corresponding data class will be pre-selected
       

3. Select the Data Element

To specify which data element your comment addresses:

  1. In the "Data Element" drop-down menu, select the specific data element you want to comment on.
  2. The drop-down menu will display only the elements available under the data class you selected in the previous step.
  3. You can use the search function within the drop-down to quickly locate a specific data element.
  4. If you are commenting on the data class itself rather than a specific element, you may leave this field blank.

Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
 

Data Class and Data Element

Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.

4. Optional: Propose New Data Class or Element

If you cannot find the appropriate data class or element for your comment:

  1. Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
  2. This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
  3. In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
  4. Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Propose New Data Class or Element

Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.

5. Complete the Comment Form

Fill out the required fields in the comment form:

Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.

6. Optional: Add Additional Comments

If you need to comment on multiple data classes or elements:

  1. After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
  2. A new comment section will appear, allowing you to enter details for your additional comment.
  3. For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
  4. Complete the Subject and Comment fields for your additional comment.
  5. Repeat this process for each additional comment you wish to submit.

Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

7. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

  • Locate the "File Upload" section at the bottom of the comment form.
  • Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

Upload Supporting Files

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

8. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

  1. Click the "Save and Exit" button at the bottom of the form.
  2. Your comment will be saved as a draft that you can access and complete later.
  3. When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
  4. Click this button to continue working on your draft.
  5. You will be taken to a review page where you can:
    1. Select "Submit Comment" to officially submit your feedback.
    2. Click "Edit" to return to the comment form and make changes
    3. Select "Discard Draft" to delete the saved draft and start fresh

Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.

9. Review and Submit

Once you have completed your comment:

  1. Click the "Review and Submit" button at the bottom of the form.
  2. This will take you to a review screen displaying your comment(s) in full.
  3. Review all information for accuracy and completeness.
  4. On this review screen, you have three options: 
    1. Click "Submit Comment" to officially submit your feedback
    2. Click "Edit" to return to the comment form and make changes
    3. Click "Discard Draft" to delete the comment and start fresh
  5. The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records. 
  6. If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Review and Submit

Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

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