| 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 |
Birth reporting use case: Healthcare facilities are required to report to state vital records offices if antibiotics were administered under two circumstances:
for the mom during labor and delivery and
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 |
CDC has requested the following use case be added to this data element in support of its 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
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| 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.
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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 component or specialization of the published data element Medication - Indication https://www.healthit.gov/isa/taxonomy/term/1546/uscdi-v4 in USCDI v4 |
|
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.