| Submitted By: Joel Andress
/ CMS
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| Data Element Information |
| Rationale for Separate Consideration |
Concept of medications in USCDIv1 does not differentiate those that are active, ordered, administered, or perscribed at discharge. A list of meds at discharge is important clinical information for continuation of care, as well as for quality measurement. |
| Use Case Description(s) |
| Use Case Description |
Medication information, including medications administered with administration details, ordered, dispensed, at discharge, and negation rationale for not using a medication are key data elements currently used in CMS eCQMs across hospital and clinician reporting programs. These data are necessary to confirm appropriate and high quality of care is received for patients across different populations. It is clinically relevant from a care perspective and a quality measurement perspective to distinguish information about medication orders, medications dispensed, medications administered, and medications at discharge.
Additionally, negation rationale, or the reason a medication was not ordered/administered is important to accurately reflect quality of care in measurement, and avoid penalizing providers/hospitals (by a lower measure score). This information is also important for interoperability to ensure relevant clinical information about not taking a medication is clear.
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| Estimate the breadth of applicability of the use case(s) for this data element
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More than 4,000 hospitals and 1 million providers are currently capturing, accessing and exchanging this encounter level information. This information is currently electronically exchanged/submitted by providers and hospitals to CMS for quality measurement purposes.eCQI resource center, includes measure specifications for CMS program eCQMs, many of which (i.e. CMS 506, CMS 108, CMS 128) use these medication details. |
| Link to use case project page |
https://ecqi.healthit.gov/ecqms |
| Use Case Description |
Data exchange of medication information is also critical for clinical care. Each step in the chain of events between a clinician’s request for a medication and the complete administration of that medication is critical for vigilance and surveillance of patient safety. Assessment, improvement and accountability around quality measurement is a consistent and critical focus of human and financial resources throughout the healthcare system. It is important to have the capacity to evaluate the clinician’s intent, the actual administration, and ongoing provision of medications across care settings and across time. Clinician’s need to exchange information about each aspect, medication orders, active medications, and medications administered to guide new treatment decisions and identify near harm and actual harm events. The metadata associated with medications (route, dose) are also critical to clinical care.
Negation rationale provides important clinical information related to deviation of care from guidelines or supported pathways. Because clinicians might be included to implement guideline driven care regardless of the setting, it is important for them to communicate negation rationale for decisions to deviate from guidelines at previous encounters. Additionally, negation rationale can provide information about patient preference that is important to travel with the patient across settings and time to optimize their experience of care.
Medication information including medications administered, discharge medications, medication orders, and medication instructions can be exchanged via C-CDA for patient care coordination.
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| Estimate the breadth of applicability of the use case(s) for this data element
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All healthcare providers using certified electronic health record technology (CEHRT) should be capturing, accessing, using and exchanging these medication data elements. The capture of medication route and dose should also be common in EHR systems. |
| Link to use case project page |
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492 |
| Use Case Description |
CDC requested the following use case be added for consideration of adding this data element to future versions of 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.
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| Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Improving provider experience of care
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| Maturity of Use and Technical Specifications for Data Element |
| Applicable Standard(s) |
Medications (including medications with dose): RxNORM
Medication Route: SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.222)
Negation Rationale (reason codes): SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.93)
https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm
Negation Rationale: https://www.hl7.org/fhir/valueset-reason-medication-not-given-codes.html , http://hl7.org/fhir/us/qicore/ValueSet-qicore-negation-reason.html
https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm
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| Additional Specifications |
HL7 FHIR US Core Implementation Guide STU3 based on FHIR R4, MedicationRequest. (https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html ) This profile supports specification of dose/route, intent (order, plan), status (active), status reason (for not done) and category (discharge)
HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, specifies MedicationAdministration, MedicationDispense profiles (http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationdispense.html ; http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationadministration.html )
HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, MedicationAdministration, MedicationDispense, MedicationRequest, NotDone profiles, for negation rationale: http://hl7.org/fhir/us/qicore/profiles.html
CMS Quality Data Model (QDM) version 5.5 Guidance (https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf)
HL7 C-CDA Release 2.0 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492)
ePrescribing NCPDP SCRIPT Standard Implementation Guide Version 2017071
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| Current Use |
Extensively used in production environments |
| Supporting Artifacts |
Medication data is routinely captured in EHR systems used by hospitals, providers, and other healthcare stakeholders including pharmacies. Medication data used in CMS program eCQMs across IQR, QPP, and Promoting Interoperability and therefore are widely stored in production environments.
Widely available in EHR systems. Medication orders and instructions are most commonly available in FHIR standards:
https://open.epic.com/Interface/FHIR
https://mydata.athenahealth.com/fhirapidoc
https://fhir.cerner.com/millennium/r4/medications/medication-request/
https://developer.allscripts.com/FHIR?PageTitle=Resources
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
https://ecqi.healthit.gov/ecqms
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
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| Extent of exchange
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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 |
Medication data for quality measurement is electronically exchanged from organization’s EHR systems to CMS for reporting and payment quality measurement programs, via QRDA files and other architectures. Negation rationale for medications is particularly relevant in quality measurement and has been used at scale in measurement. Ongoing testing for exchanging these data in FHIR standards via HL7 Connectathons.
Medication data is also routinely electronically exchanges with external organizations via C-CDA, as part of ONC’s CEHRT criteria, and a part of data exchange for electronic prescribing to support the continuum of care, particularly with prescribers, dispensers, intermediaries, and post-acute care settings.
https://ecqi.healthit.gov/qrda
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7
https://www.healthit.gov/isa/section/electronic-prescribing
https://confluence.hl7.org/display/FHIR/2020-09+Clinical+Reasoning
https://ecqi.healthit.gov/qrda
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| Potential Challenges |
| Restrictions on Standardization (e.g. proprietary code) |
No challenges anticipated. This data is available in standard terminology that can be publicly access via the VSAC and HL7. |
| Restrictions on Use (e.g. licensing, user fees) |
We are not aware of any restrictions. |
| Privacy and Security Concerns |
This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data. |
| Estimate of Overall Burden |
Medication data is regularly captured as part of EHR systems. Most hospitals, including critical access hospitals, and providers are already capturing and exchanging these medication data for quality measurement to CMS. Some additional efforts may be necessary to specify negation rationale, for those stakeholders not using for measurement, but the information is clinically relevant for a variety of use cases.
Many Medication FHIR profiles also required by the US Core Capability Statement and therefore will be stood up by those stakeholders complying with the ONC requirement for the Standardized API for patient and population services—some additional efforts to add in profiles to clarify medication administration and dispensing.
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| Other Implementation Challenges |
N/A |
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
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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
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Level 0
- Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
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Criterion #3
Maturity - Current Exchange |
Level 0
- Data element is electronically exchanged in limited environments, such as connectathons or pilots.
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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.
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| Evaluation Comment |
This data element is a specialization or subset of an existing USCDI v4 data element Medications. |
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Official Website of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT
Submitted by Svellanky on
CMS-CCSQ/CDC Joint USCDIv4 Priority - Discharge Medications
CMS urges adding more specificity to the USCDI Medications Data Class as interoperability of medication information and management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises—we continue to support the concept of a USCDI Task Force to appropriately specify and advance this important data class. The highlighted additional data elements serve the ONC USCDI v4 stated priorities related to mitigating health inequities and disparities, addressing needs of underserved populations, and addressing public health reporting needs. Specifically, these medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access.
The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/dispensed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. These detailed medication data were also previously identified as a joint CMS-CDC priority area as they are used extensively in quality measurement and public health —for example, to monitor and respond to antibiotic prescribing patterns that facilitate the emergence of drug-resistant pathogens, but also exposes patients to needless risk for adverse effects. They are also routinely exchanged when prior authorization is required.
Maturity: These elements are classified as Level 2 by ONC and continues to have strong standardization and be in wide use.