Description (*Please confirm or update this field for the new USCDI version*)
Explanation or justification provided when an order or practice guideline is not carried out.
Usage note: Should be included with a procedure, immunization, and medication.
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.
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.
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
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.
The Alliance for Nursing Informatics (ANI) strongly supports the addition of Reason Not Performed to the Healthcare Information Attributes data class and considers it one of the most critical additions in Draft v7 for nursing documentation integrity. Nurses routinely document clinical omissions, including medications refused by patients, procedures deferred due to clinical deterioration, and immunizations contraindicated, yet this documentation has historically been captured as free text in nursing notes or not at all in a structured, interoperable format. The absence of a standardized Reason Not Performed element systematically distorts quality measure performance reporting, causing clinically justified omissions to appear as failures of care and creating inequitable quality measurement outcomes for providers and health systems with higher-acuity or more complex patient populations. ANI advocates for explicit vocabulary specification for this element and requests that the reference value set include nursing-specific reason codes such as patient refusal, clinical contraindication, patient not present, and patient condition precluding the intervention.
The SNOMED CT Situation hierarchy has coding for Procedure declined (situation): 1296859006, and all its descendants.
The SNOMED CT Situation hierarchy has coding for Vaccine declined by patient (situation): 591000119102, and all its descendants.
The SNOMED CT Situation hierarchy has coding for Medication declined (situation): 406149000, and all its descendants.
SNOMED CT needs to be a required standard for Reason Not Performed to remain consistent with the CMS Quality Payment Program (QPP) technical specifications.
Recommendation: The PACIO Project* community supports inclusion of Reason Not Performed in the final version of USCDI v7.
Rationale: This information is useful to providers and in-the-moment decisions that are not consistent with documented advance healthcare directive information, given than much of this information is buried within notes or unstructured components of advance healthcare directive documents. Providers could use this as a means of substantiating why treatment decisions were made that are not consistent with available information to support measurement of quality and expressed individual treatment preferences.
* The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, that aims to advance interoperable health information exchange between post-acute care (PAC) providers, patients, and other key stakeholders across health care.
SHIELD supports the inclusion of this data element, but notes that clarification is needed if this covers cancelations of orders as well as providing reasons why results could not be obtained. There are a variety of reasons why tests are not performed, in some cases it may be due to the condition of a specimen. Other words that could be used to describe some of these situations are cancelation reason or specimen reject reason.
SHIELD suggests to update the usage note to state: "Usage note: Should be included with procedures, immunizations, medications, laboratory results and orders when they are not performed."
APHL supports the inclusion of this data element but notes that clarification is needed that this covers cancelations of orders as well as providing reasons why results could not be obtained. There are a variety of reasons why tests are not performed, in some cases it may be due to the condition of a specimen. We request that ONC update the usage notes to make these clarifications. We also suggest updating the usage notes to give examples of use cases in which Reason Not Performed would be used, such as with procedures, immunizations, medications, laboratory results and orders.
Draft USCDI v7 introduces the new data class of “Healthcare Information Attributes” that contains the “Reason Not Performed” data element.[1]Vizient supports the addition of this data element, as it has the potential to improve clarity around clinical decision‑making and the additional reasons why an order or practice guideline is not carried out.
[1] This specifies structured information about why an ordered test, procedure, immunization, or other planned intervention did not occur, such as patient refusal, clinical contraindication, or logistical constraints.
Vizient recommends adding the Negation Rationale data element to USCDI v5 as this element will allow for analyses as to what medication orders are being placed and then subsequently cancelled on a regular basis in addition to why they are being cancelled.
Vizient recommends adding the Negation Rationale data element to USCDI v4 as this element will allow for analyses as to what medication orders are being placed and then subsequently cancelled on a regular basis in addition to why they are being cancelled.
Collected as part of antiretroviral history for routine HIV surveillance.
Collected for Tuberculosis (TB) and Latent Tuberculosis Infection (LTBI) Surveillance and are included in the TB and LTBI Message Mapping Guides (MMG). https://ndc.services.cdc.gov/mmgpage/tuberculosis-and-latent-tb-infection-message-mapping-guide/
Important for National Healthcare Safety Network (NHSN) measures, including hypoglycemia and Clostridioides difficile (C Diff).
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Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
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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.
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Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
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Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
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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.
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Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by mturchioe on
ANI's comment on USCDI draft v7: Reason Not Performed
The Alliance for Nursing Informatics (ANI) strongly supports the addition of Reason Not Performed to the Healthcare Information Attributes data class and considers it one of the most critical additions in Draft v7 for nursing documentation integrity. Nurses routinely document clinical omissions, including medications refused by patients, procedures deferred due to clinical deterioration, and immunizations contraindicated, yet this documentation has historically been captured as free text in nursing notes or not at all in a structured, interoperable format. The absence of a standardized Reason Not Performed element systematically distorts quality measure performance reporting, causing clinically justified omissions to appear as failures of care and creating inequitable quality measurement outcomes for providers and health systems with higher-acuity or more complex patient populations. ANI advocates for explicit vocabulary specification for this element and requests that the reference value set include nursing-specific reason codes such as patient refusal, clinical contraindication, patient not present, and patient condition precluding the intervention.