Medications

CMS-CCSQ Supports Medication Admin Reason Reference for USCDI v6

Recommendation: CMS CCSQ recommends the Date Medication Administered, Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference data elements be advanced to Level 2 and added to final USCDI v6.

Rationale: CMS CCSQ, CDC, and the Council of State and Territorial Epidemiologists (CSTE) requests the inclusion of the Date Medication Administered (Level 0), Medication Administered Code (Level 0), Medication Administration Dose (Level 0), and Medication Administered Reason Reference (Level 0) data elements in USCDI to fill critical gaps in patient safety and care quality. Medication administration remains a key priority for CMS and CDC programs as it’s essential for quality improvement and public health surveillance. Moving these data elements to USCDI v6 would support access to critical information to care providers. These data elements are important for medication reconciliation and continuity of care especially during transitions of care between acute and post-acute settings. Existing Medications Class data elements in USCDI record when a medication has been ordered or dispensed, but they do not reflect the data associated with the actual administration of the medication to the patient. These medication administration data elements are critical for providing this clarification. They are also supported by RxNorm. Including Medication Administration data elements in USCDI v6 would also facilitate documentation and use of medication related data already being collected in health care settings, including on the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) (CMS IRF-PAI Manual Version 42; Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) and IRF-PAI Manual), the Minimum Data Set (MDS) (Long-Term Care Facility (LTCF) Resident Assessment Instrument (RAI) 3.0 User Manual Version 1.19.1;  MDS 3.0 RAI Manual), OASIS (OASIS User Manuals), and Long-Term Care Hospital (LTCH) Continuity Assessment Record and Evaluation (CARE) (LTCH CARE Data Set (LCDS) & LCDS Manual).

Several technical and practical considerations also support this recommendation:

    i. The Medication Administered Code data element is represented in both the PACIO Standard Medication Profile (SMP) IG and the Vulcan Real World Data (RWD) IG. It can be captured, stored, and exchanged electronically in all EHRs, supporting use cases like prior authorization application programming interfaces (APIs) and provider-payer APIs. This data element applies across all healthcare settings and diagnoses.

    ii. The Medication Administered Dose data element is similarly represented in the PACIO SMP IG and the HL7 Clinical Document Architecture (CDA) IG.

Applicable standards: 

    i. Date Medication Prescribed and Date Medication Administered: dateTime Data Type

    ii. Time Medication Prescribed Code and Medication Administered Code: RxNorm

    iii. Medication Prescribed Dose Units and Medication Administration Dose Units: Unified Code for Units of Measure

Together, these data elements fill essential gaps in medication reconciliation, facilitate smoother care transitions, and contribute to better patient outcomes through improved medication administration tracking and coordination across care settings.

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

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.

CDC's Comment for draft USCDI v5

CDC supports the inclusion of this data element in USCDI v5 as it is an element that may be necessary for calculation of our digital quality metrics from FHIR data.

CDC's comment on behalf of CSTE for USCDI v5

 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.

CDC's Consolidated Comment for USCDI v5

• ** ADD THIS USE CASE TO SUBMISSION **

1. "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.
2. "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.

NACCHO supports CDC's recommendations.

Please include Medication Administration elements in USCDI v4

• The record of an actual administration of a medication to a patient is one of the most central healthcare use cases.  Currently a suite of Medication administration-related concepts are in the Level 2 section of USCDI.   All of these are central healthcare components so the longer the data for these concepts remain wildly unstandardized in US EHRs, the longer there will be no realistic expectation of interoperability. There are many strong justifications for need of standardized structured data of this concept the clinical research/regulatory sphere, one of which I make below. 
• However, I want to emphasize these elements are not niche needs for a few research requirements.  These are the center of patient-provider data exchange and the continued lack of standardized representation of these concepts should be the single driving reason for their inclusion in USCDI version 4.
• Healthcare use case: The lack of any standardized representation of administration of medications inherently prevents interoperability of this information and restricts critical sharing of this information across health systems (such us in those qHINs participating in TEFCA).  Lack of easy sharing of administered drugs can result in serious, sometimes lethal, misjudgments on patient medication usage.
• An FDA/clinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for safety or efficacy for new indications of existing medications. In such analyses there may be one or more “exposure” drugs (ie, the drug of interest) and one or many “concomitant” medications. Researchers and regulatory reviewers will need to know enough information of the status of a drug administration where applicable. This information will supply critical differential information with which a researcher or regulatory reviewer can assess the relative probability of the listed drug record actually resulting in consumption by the patient. They can then determine the utility of the information in the context of the specific research and evidence generation needs of any given clinical study.

CDC's Consolidated Comment for USCDI v4

CDC strongly supports inclusion of this element in USCDI v4.

Also, please add the following use case:  

• Birth reporting use case: Healthcare facilities are required to report to state vital records offices if antibiotics were administered under two circumstances:       

1. for the mom during labor and delivery and 
2. 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. 

CDC's Consolidated Comment

Reason for medication prescription or administration is particularly important as medications can be used for multiple conditions, and for off-label use. Documentation of the specific reason a medication is administered is integral to understanding a patient’s specific condition.

Collected as part of antiretroviral history for routine HIV surveillance.

Additional Technical Specifications: HL7 FHIR Health Care Surveys Content Implementation Guide (http://hl7.org/fhir/us/health-care-surveys-reporting/2022Jan/); HL7 FHIR Central Cancer Registry Reporting Content Implementation Guide (http://hl7.org/fhir/us/central-cancer-registry-reporting/2022Jan/).