Medications

CMS-CCSQ Supports Medication Administered Code 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.

This must be included in USCDI

• This MUST finally be included in USCDI.  Multiple agencies have made a STRONG case for this. Continued lack of inclusion in USCDI is difficult to comprehend as at is a basic healthcare component used widely around the globe.  Additionally, relegation all the way to Level 0 contradicts all fact:
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• Not represented by a terminology standard or SDO-balloted technical specification or implementation guide:  FALSE: Represented by many FHIR IG's including Vulcan RWD IG (https://build.fhir.org/ig/HL7/vulcan-rwd/) , AU Base Medication Administration - AU Base Implementation Guide v4.2.2-ci-build (fhir.org), Home - Epic on FHIR, etc)
• In the Vulcan RWD IG, the IG does not ask for very much, but it does expect Administered Medication to be standardized in HL7 FHIR.  The minimum the RWD IG requires is 
• ... status        code    in-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
  ... medication[x]    CodeableConcept, Reference(Medication)    What was administered
  ... subject    S    1..1        Who received medication
  ... effective[x]    dateTime, Period    Start and end time of administration
• Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
• Data element is electronically exchanged in limited environments, such as connectathons or pilots: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
• Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
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• Level 2 at minimum is more accurate, and it used to be in Level 2.  And it really should be part of USCDI
• Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
• Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
• Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
• Use cases apply to most care settings or specialties.

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-CMS Joint Priority Data Element. 

See letter here (submitted on 1/29/2024): https://www.healthit.gov/isa/sites/isa/files/2024-02/FINAL_CDC%20and%20CMS-CCSQ%20Joint%20USCDI%20v5%20submission%20letter_012924.pdf

CDC and CMS-CCSQ Joint Support for Medication Admin. Code

Thank you for opportunity to comment on this data element. The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) emphasize the importance of patient safety being reflected in the USCDI standards. As an integral aspect of patient safety, medication management is critical to patient care and coordination between providers, and related quality and public health enterprises. Medication administration, specifically, is a critical concept for CMS and CDC programs that support quality improvement and public health surveillance. We continue to emphasize the need for greater specificity in the USCDI Medications data class. The medications data class in USCDI is currently inadequate to support patient safety, quality improvement, or public health. The medication data elements do not differentiate among medications that are active, ordered, and administered/prescribed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care and promote patient safety. CMS and CDC strongly recommend the Medication Administration (Level 2)/Medication Administered Code (Level 0) in the Medications data class be added to USCDI.

CDC's comment on behalf of CSTE for USCDI v5

• CSTE strongly agrees with CDC.
• 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 Consolidated Comment for USCDI v5

• CDC-CMS joint priority justification: CMS and CDC urge 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 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. Specifically on medication administration, the completion of an administration is important clinical information to ensure appropriate clinical care, and is used in quality measurement and across public health reporting systems, including vital records, electronic case reporting (e.g. routine HIV and LTBI/TB surveillance), and the antibiotic use and resistance (AUR) module of CDC's National Healthcare Safety Network. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/prescribed to the patient. And this lack of differentiation presents significant challenges to joint agency enterprises such as patient safety surveillance and quality measurement in inpatient settings. For example, measurements for hypoglycemia (an important quality measure) rely on patients having received a certain medication -- not solely having the medication ordered. Orders are insufficient for this purpose because orders may be PRN or range orders and therefore not reflect what the patient actually received. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. Medication details 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. FHIR Resource: Medication Administration

• ** 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 Comment.

Additional comment from CDC for USCDI v4

• Additional Use Cases from Department of Oral Health

1. Medication - Opioid Overdose: 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. Medication - Antibiotic Overuse: 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.

CDC's Consolidated Comment for USCDI v4

• CDC-CMS joint priority 

CMS and CDC urge 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 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. Specifically on medication administration, the completion of an administration is important clinical information to ensure appropriate clinical care and is used in quality measurement and across public health reporting systems, including vital records, electronic case reporting (e.g., routine HIV and LTBI/TB surveillance), and the antibiotic use and resistance (AUR) module of CDC's National Healthcare Safety Network. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and administered/prescribed to the patient. And this lack of differentiation presents significant challenges to joint agency enterprises such as patient safety surveillance and quality measurement in inpatient settings. For example, measurements for hypoglycemia (an important quality measure) rely on patients having received a certain medication -- not solely having the medication ordered. Orders are insufficient for this purpose because orders may be PRN or range orders and therefore not reflect what the patient received.
Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. Medication details 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.
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 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 and are routinely exchanged when prior authorization is required

• Additional use case: Patient safety quality measurement and public health surveillance via NHSN
• Comments from NACCHO: NACCHO is looking for more information on completion of medication status codes and types of order codes representing various scenarios such as when a patient is not in care. It is necessary to be accurately differentiated for quality clinical care. While it has added benefits to the public health, there is a necessity of more clarity on this data element
• Comments from CSTE: CSTE agrees with CDC. 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.