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.
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).
The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.
If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.
If you are only commenting on a single data class or element, you may leave this field blank.
2. Select the Data Class
To specify which data class your comment addresses:
In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
Note that the Data Class field will automatically populate based on your current location in the platform:
If you are on a data class page, the field will be set to that specific data class
If you are on a data element page, the corresponding data class will be pre-selected
3. Select the Data Element
To specify which data element your comment addresses:
In the "Data Element" drop-down menu, select the specific data element you want to comment on.
The drop-down menu will display only the elements available under the data class you selected in the previous step.
You can use the search function within the drop-down to quickly locate a specific data element.
If you are commenting on the data class itself rather than a specific element, you may leave this field blank.
Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
If you cannot find the appropriate data class or element for your comment:
Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
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.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
If you need to comment on multiple data classes or elements:
After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
The platform allows you to upload supporting documentation to enhance your comment:
Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.
Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.
Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
8. Optional: Save and Exit
If you need to pause your work and return to complete your comment later:
Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
Click this button to continue working on your draft.
You will be taken to a review page where you can:
Select "Submit Comment" to officially submit your feedback.
Click "Edit" to return to the comment form and make changes
Select "Discard Draft" to delete the saved draft and start fresh
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.
9. Review and Submit
Once you have completed your comment:
Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
Click "Submit Comment" to officially submit your feedback
Click "Edit" to return to the comment form and make changes
Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Official Website of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT
Submitted by erjones on
Please Include Negation Rationale in USCDI v5
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.