Medications

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.

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.

CMS/CDC Joint USCDIv4 Priority: Medication Administered Code

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 actually 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 routinely exchanged when prior authorization is required.

Maturity: These elements are classified as Level 2 by ONC and continues to have strong standardization and be in wide use.

• Current standards:
  • In FHIR US Core, there is a distinction between "Medication" and "Medication Request”; base FHIR and FHIR Quality Improvement (QI) Core IG includes "Medication Administration" and “Medication Request” profiles.
  • Within Medication Request, the ‘category’ is used to define discharge medications.
• Current uses, exchange, and use cases: Medication data are routinely captured in electronic health record (EHR) systems used by hospitals, providers, and other healthcare stakeholders, including pharmacies, and are routinely exchanged across providers and payers. Medication data are used extensively in CMS quality measurement and public health for surveilling national trends. Additionally, when prior authorization is necessary for a medication, details related to the medication (e.g., why the medication is given, the quantity needed) are exchanged to support the approval process. As noted in the ISWG recommendations report for USCDI v3, many medication data elements are already required for Health Information Technology (IT) Certification via other standards (National Council for Prescription Drug Programs [NCPDP] SCRIPT, Consolidated Clinical Document Architecture [C-CDA]) and are therefore already routinely exchanged, posing little additional burden by adding them to the USCDI.

CDC's comment on behalf of CSTE for USCDI v4

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.