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

Data Element
Negation Rationale
Submitted By: Joel Andress / CMS
Data Element Information
Data Element Description Documentation of a reason an activity (medication ordered, administered, dispensed) is not performed. This may include patient refusal, drug interaction, or situational reasons
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.
Estimate the breadth of applicability of the use case(s) for this data element 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.
Estimate the breadth of applicability of the use case(s) for this data element 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
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
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
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
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
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 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
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.
Other Implementation Challenges N/A

Comment

Submitted by CDC_DSMH_WG on

Unified Comment from CDC

This element is used by CMS Quality Reporting and is marked Required or MustSupport in the FHIR QI Core IG

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