Data Element
Submitted By: Maria Michaels / CDC
Data Element Information
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 CDC requested this use case be added in support:
"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
ONC 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 1 - Data element is electronically exchanged between two production EHRs or other HIT modules 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 component or specialization of the data element Medication - Dose Units https://www.healthit.gov/isa/taxonomy/term/1516/uscdi-v4, published in USCDI v4.

Comment

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 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 nedragarrett_CDC on

CDC's Comment for draft USCDI v5

CDC supports the inclusion of this data element in USCDI v5 as it is an element that may be necessary for calculation of our digital quality metrics from FHIR data.

Submitted by gsgordon on

Please include Medication Administration elements in USCDI v4

  • The record of an actual administration of a medication to a patient is one of the most central healthcare use cases.  Currently a suite of Medication administration-related concepts are in the Level 2 section of USCDI.   All of these are central healthcare components so the longer the data for these concepts remain wildly unstandardized in US EHRs, the longer there will be no realistic expectation of interoperability. There are many strong justifications for need of standardized structured data of this concept the clinical research/regulatory sphere, one of which I make below. 
  • However, I want to emphasize these elements are not niche needs for a few research requirements.  These are the center of patient-provider data exchange and the continued lack of standardized representation of these concepts should be the single driving reason for their inclusion in USCDI version 4.
  • Healthcare use case: The lack of any standardized representation of administration of medications inherently prevents interoperability of this information and restricts critical sharing of this information across health systems (such us in those qHINs participating in TEFCA).  Lack of easy sharing of administered drugs can result in serious, sometimes lethal, misjudgments on patient medication usage.
  • An FDA/clinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for safety or efficacy for new indications of existing medications. In such analyses there may be one or more “exposure” drugs (ie, the drug of interest) and one or many “concomitant” medications. Researchers and regulatory reviewers will need to know enough information of the status of a drug administration where applicable. This information will supply critical differential information with which a researcher or regulatory reviewer can assess the relative probability of the listed drug record actually resulting in consumption by the patient. They can then determine the utility of the information in the context of the specific research and evidence generation needs of any given clinical study.

Submitted by nedragarrett_CDC on

CDC's comment on behalf of CSTE for USCDI v4

CSTE 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. 

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment

CSTE Comment:

  • 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.

Submitted by nedragarrett_CDC on

Unified Comment from CDC

  • Additional Use Case: Information about medications prescribed, administered, and reasons for prescribing are collected as part of CDC's routine nationally notifiable condition surveillance for HIV, tuberculosis and sexually transmitted diseases. This information is collected to understand trends in treatment initiation and completion (as applicable), and as part of a health department's case management work.
     
  • Number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of HIV Prevention, Division of TB Elimination and Division of STD Prevention flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.
     
  • Healthcare Aims: Improving patient experience of care, Improving health of populations, Reducing cost of care, Improving provider experience of care
     
  • Use of data element: Extensively used in production environments
     
  • CSTE supports inclusion of this measure into USCDI v3: helpful for PH to know if treatment was administered or prescribed to indicate a need to contact patient and connect with other wraparound services/linkage to care (e.g., STIs, Hepatitis C/B)

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