eCQM QICore Content Implementation Guide
2024.0.0 - CI Build

eCQM QICore Content Implementation Guide, published by cqframework. This guide is not an authorized publication; it is the continuous build for version 2024.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cqframework/ecqm-content-qicore-2024/ and changes regularly. See the Directory of published versions

Measure: Hospital Harm - Opioid-Related Adverse EventsFHIR

Official URL: https://madie.cms.gov/Measure/HospitalHarmOpioidRelatedAdverseEventsFHIR Version: 0.1.000
Draft as of 2024-07-09 Responsible: Centers for Medicare & Medicaid Services (CMS) Computable Name: HospitalHarmOpioidRelatedAdverseEventsFHIR
Other Identifiers: Short Name (use: usual, ), UUID:30256069-ee4f-45b8-895a-5452cf8e9e4e (use: official, ), UUID:8f15b4f6-b1b5-41a0-b158-282ff051a62d (use: official, ), Endorser (use: official, ), Publisher (use: official, )

Copyright/Legal: Limited proprietary coding is contained in the Measure specifications for user convenience. Users of proprietary code sets should obtain all necessary licenses from the owners of the code sets. American Institutes for Research(R), formerly IMPAQ International, disclaims all liability for use or accuracy of any third party codes contained in the specifications.

LOINC(R) copyright 2004-2023 Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms(R) (SNOMED CT[R]) copyright 2004-2023 International Health Terminology Standards Development Organisation. ICD-10 copyright 2023 World Health Organization. All Rights Reserved.

This measure assesses the number of inpatient hospitalizations for patients age 18 and older who have been administered an opioid medication and are subsequently administered an opioid antagonist within 12 hours, an indication of an opioid-related adverse event

UNKNOWN

Title: Hospital Harm - Opioid-Related Adverse EventsFHIR
Id: HospitalHarmOpioidRelatedAdverseEventsFHIR
Version: 0.1.000
Url: Hospital Harm - Opioid-Related Adverse EventsFHIR
short-name identifier:

CMS819FHIR

version-independent identifier:

urn:uuid:30256069-ee4f-45b8-895a-5452cf8e9e4e

version-specific identifier:

urn:uuid:8f15b4f6-b1b5-41a0-b158-282ff051a62d

endorser (CMS Consensus Based Entity) identifier:

3501e

publisher (CMS) identifier:

819FHIR

Effective Period: 2025-01-01..2025-12-31
Status: draft
Publisher: Centers for Medicare & Medicaid Services (CMS)
Author: American Institutes for Research (AIR)
Description:

This measure assesses the number of inpatient hospitalizations for patients age 18 and older who have been administered an opioid medication and are subsequently administered an opioid antagonist within 12 hours, an indication of an opioid-related adverse event

Purpose:

UNKNOWN

Copyright:

Limited proprietary coding is contained in the Measure specifications for user convenience. Users of proprietary code sets should obtain all necessary licenses from the owners of the code sets. American Institutes for Research(R), formerly IMPAQ International, disclaims all liability for use or accuracy of any third party codes contained in the specifications.

LOINC(R) copyright 2004-2023 Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms(R) (SNOMED CT[R]) copyright 2004-2023 International Health Terminology Standards Development Organisation. ICD-10 copyright 2023 World Health Organization. All Rights Reserved.

Disclaimer:

This performance measure is not a clinical guideline, does not establish a standard of medical care and has not been tested for all potential applications.

THE MEASURES AND SPECIFICATIONS ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND.

Due to technical limitations, registered trademarks are indicated by (R) or [R] and unregistered trademarks are indicated by (TM) or [TM].

Scoring:

Proportion

Rationale:

Opioids are often the foundation for sedation and pain relief. Opioid-based analgesia continues to be the most commonly used treatment in postoperative pain management, with more than 95% of surgical patients receiving opioids during their hospitalization (Baker et al., 2020). However, use of opioids can also lead to serious adverse events, including constipation, over sedation, delirium, and respiratory depression (Urman, 2021a). Opioid-related adverse events (ORADE) have both patient-level and financial implications. The presence of an ORADE was associated with a 55% longer postoperative length of stay, 29% lower odds of discharge home, and 2.9 times the odds of death (Urman, 2021b). For surgical patients, occurrence of opioid-related adverse events was associated with an increase of 1.6 days in LOS and $8225 more in cost for the index hospitalization. Patients who experienced ORADEs while in a hospitalized setting were more likely to have received a higher total dose of opioids during hospitalization (Cone et al., 2023; Shafi et al., 2018). Numerous studies report the additive (risk-adjusted) hospitalization cost burden of surgical patients with ORADEs to be between $4350–$8225, representing a 27–47% increase in (risk-adjusted) admission costs (Khanna et al., 2021).

Most opioid-related adverse events are preventable. Each year, adverse drug events (ADE) account for nearly 700,000 emergency department visits and 100,000 hospitalizations (AHRQ, 2019). An estimated one-third of all adverse events that occur in the inpatient setting are adverse drug events (ODPHP, 2020). Additionally, in a closed-claims analysis, 97% of adverse events were judged preventable with better monitoring and response (Lee et al., 2015). Naloxone administration is often used as an indicator of a severe opioid-related adverse event, and implementation of this measure can advance safe use of opioids in hospitals and prevent these serious and potentially lethal adverse drug events.

Clinical recommendation statement:

Naloxone is an opioid reversal agent typically used for severe opioid-related adverse events. Naloxone administration has been used in a number of studies as an indicator of opioid-related adverse events (Yiu, et al., 2022; Lynn et al., 2017; Nwulu et al., 2013).

From Section 10 of the 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Lavonas et al., 2015), the following recommendation is listed for use of naloxone:

Naloxone is a potent opioid receptor antagonist in the brain, spinal cord, and gastrointestinal system. Naloxone has an excellent safety profile and can rapidly reverse central nervous system (CNS) and respiratory depression in a patient with an opioid-associated resuscitative emergency.

2020 American Heart Association guidelines update for cardiopulmonary resuscitation continue to recommend naloxone for a patient with suspected opioid overdose who has a definite pulse but no normal breathing or only gasping (i.e., a respiratory arrest), in addition to providing standard Pediatric Basic Life Support (PBLS) or Pediatric Advanced Life Support (PALS), it is reasonable for responders to administer intramuscular or intranasal naloxone. These recommendations are identical for adults.

In February 2022, FDA approved its abbreviated new drug application for nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL). Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose (FDA, 2022). In contrast to naloxone, the long half-life of nalmefene is similar to or greater than that of many opioid receptor agonists (Britch et al., 2022), which could decrease the need for repeat drug administration. In May 2023, FDA approved nalmefene hydrochloride nasal spray that delivers 2.7 milligrams (mg) of nalmefene into the nasal cavity.

Guidance (Usage): Qualifying encounters (denominator) include all patients 18 years of age or older at the start of the encounter with at least one opioid medication administered outside of the operating room. To create the numerator: 1. First, start with those encounters meeting denominator criteria 2. Next, remove all events where an opioid or opioid antagonist was administered in the operating room. Opioid antagonist administrations in the operating room are excluded because they could be part of the sedation plan as administered by an anesthesiologist. Encounters that include use of opioid antagonists for procedures and recovery outside of the operating room (e.g., bone marrow biopsy and PACU) are included in the numerator, as it would indicate the patient was over-sedated. Note that should a facility not utilize temporary patient locations, alternative times may be used to determine whether a patient is in the operating room during opioid antagonist administration. Since anesthesia end time could represent the time the anesthesiologist signed off, and thus may include the patient’s time in the PACU, this should be avoided. 3. Next, remove all events where the opioid antagonist was administered via an enteral route. Only opioid antagonists given by a non-enteral (i.e., intravenous, intramuscular, subcutaneous, intranasal, inhalation) route are considered. 4. Finally, remove all administrations of opioid antagonists that were given greater than 12 hours following hospital administration of an opioid medication. This eCQM is an episode-based measure. An episode is defined as each inpatient hospitalization or encounter that ends during the measurement period. This FHIR-based measure has been derived from the QDM-based measure: CMS819v3. Please refer to the HL7 QI-Core Implementation Guide(https://hl7.org/fhir/us/qicore/STU4.1.1/) for more information on QI-Core and mapping recommendations from QDM to QI-Core4.1.1 (https://hl7.org/fhir/us/qicore/STU4.1.1/qdm-to-qicore.html).
Population Criteria:
6501fc94da013638e7b3dc06
Initial Population: Inpatient hospitalizations for patients age 18 years and older during which at least one opioid medication was administered outside of the operating room
Denominator: Equals Initial Population
Numerator: Inpatient hospitalizations where an opioid antagonist was administered outside of the operating room and within 12 hours following an opioid medication administered outside of the operating room. The route of administration of the opioid antagonist must be by intranasal spray, inhalation, intramuscular, subcutaneous, or intravenous injection. Only one numerator event is counted per encounter.
Supplemental Data Elements:

SDE Ethnicity

SDE Payer

SDE Race

SDE Sex

Supplemental Data Guidance : For every patient evaluated by this measure also identify payer, race, ethnicity and sex; SDE Ethnicity SDE Payer SDE Race SDE Sex
Libraries:
HospitalHarmOpioidRelatedAdverseEventsFHIR
Terminology and Other Dependencies:
  • Library/SupplementalDataElements|3.5.000
  • Library/FHIRHelpers|4.4.000
  • Library/QICoreCommon|2.1.000
  • Library/CQMCommon|2.2.000
  • AdministrativeGender
  • http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1248.119
  • Opioids, All
  • Encounter Inpatient
  • Observation Services
  • Emergency Department Visit
  • http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1248.141
  • http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1248.187
  • Payer
  • Parameters:
    name use min max type
    Measurement Period In 0 1 Period
    SDE Sex Out 0 1 Coding
    Numerator Out 0 * Resource
    Denominator Out 0 * Resource
    SDE Payer Out 0 * Resource
    Initial Population Out 0 * Resource
    SDE Ethnicity Out 0 1 Resource
    SDE Race Out 0 1 Resource
    DataRequirements:
    Resource Type Resource Elements Valueset Name Valueset
    Patient(QICorePatient) ethnicity race
    MedicationAdministration(QICoreMedicationAdministration) medication status status.value effective dosage dosage.route Opioid Antagonist http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1248.119
    MedicationAdministration(QICoreMedicationAdministration) medication status status.value effective dosage dosage.route Opioids, All Opioids, All
    Encounter(QICoreEncounter) type status status.value period location Observation Services Observation Services
    Encounter(QICoreEncounter) type status status.value period location Emergency Department Visit Emergency Department Visit
    Encounter(QICoreEncounter) type period status status.value location Encounter Inpatient Encounter Inpatient
    Location(QICoreLocation) id id.value
    Coverage(QICoreCoverage) type period Payer Type Payer
    Direct Reference Codes:
    display code system
    Male M http://hl7.org/fhir/administrative-gender
    Female F http://hl7.org/fhir/administrative-gender
    Logic Definitions:
    Group Scoring Population Criteria Expression
    6501fc94da013638e7b3dc06 Group scoring: proportion Measure scoring:

    Proportion

    Type:

    Outcome

    Rate Aggregation: None
    Improvement Notation:

    decrease

    Initial Population
    define "Initial Population":
      "Encounter with Opioid Administration Outside of Operating Room"
    Denominator
    define "Denominator":
      "Initial Population"
    Numerator
    define "Numerator":
      "Encounter with Non Enteral Opioid Antagonist Administration Outside of Operating Room and within 12 Hrs After Opioid"
    Library Name Name
    SupplementalDataElements SDE Sex
    define "SDE Sex":
      case
        when Patient.gender = 'male' then "M"
        when Patient.gender = 'female' then "F"
        else null
      end
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR SDE Sex
    define "SDE Sex":
      SDE."SDE Sex"
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Opioid Antagonist Administration
    define "Opioid Antagonist Administration":
      ["MedicationAdministration": "Opioid Antagonist"] AntagonistGiven
        where AntagonistGiven.status = 'completed'
          and AntagonistGiven.status != 'not-done'
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Opioid Administration
    define "Opioid Administration":
      ["MedicationAdministration": "Opioids, All"] Opioids
        where Opioids.status = 'completed'
          and Opioids.status != 'not-done'
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Qualifying Encounter
    define "Qualifying Encounter":
      ["Encounter": "Encounter Inpatient"] InpatientEncounter
        where AgeInYearsAt(date from start of InpatientEncounter.period) >= 18
          and InpatientEncounter.period ends during day of "Measurement Period"
          and InpatientEncounter.status = 'finished'
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Encounter with Opioid Administration Outside of Operating Room
    define "Encounter with Opioid Administration Outside of Operating Room":
      "Qualifying Encounter" InpatientEncounter
        with "Opioid Administration" OpioidGiven
          such that QICoreCommon."ToInterval" ( OpioidGiven.effective ) starts during CQMCommon."HospitalizationWithObservation" ( InpatientEncounter )
            and not exists ( InpatientEncounter.location EncounterLocation
                where CQMCommon.GetLocation ( EncounterLocation.location ).type in "Operating Room Suite"
                  and QICoreCommon."ToInterval" ( OpioidGiven.effective ) starts during EncounterLocation.period
            )
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Initial Population
    define "Initial Population":
      "Encounter with Opioid Administration Outside of Operating Room"
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Denominator
    define "Denominator":
      "Initial Population"
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Encounter with Non Enteral Opioid Antagonist Administration Outside of Operating Room and within 12 Hrs After Opioid
    define "Encounter with Non Enteral Opioid Antagonist Administration Outside of Operating Room and within 12 Hrs After Opioid":
      // Opioids administered before opioid antagonist AND excludes opioid antagonist administered in operating room AND limits opioid antagonist to non-enteral routes//
      
      from
        "Opioid Antagonist Administration" OpioidAntagonistGiven,
        "Opioid Administration" OpioidGiven,
        "Denominator" EncounterWithQualifyingAge
        where not exists ( EncounterWithQualifyingAge.location EncounterLocation
            where CQMCommon.GetLocation ( EncounterLocation.location ).type in "Operating Room Suite"
              and QICoreCommon."ToInterval" ( OpioidAntagonistGiven.effective ) starts during EncounterLocation.period
        )
          and ( QICoreCommon."ToInterval" ( OpioidAntagonistGiven.effective ) starts during CQMCommon."HospitalizationWithObservation" ( EncounterWithQualifyingAge )
              and QICoreCommon."ToInterval" ( OpioidGiven.effective ) starts during CQMCommon."HospitalizationWithObservation" ( EncounterWithQualifyingAge )
              and QICoreCommon."ToInterval" ( OpioidGiven.effective ) ends 12 hours or less before start of QICoreCommon."ToInterval" ( OpioidAntagonistGiven.effective )
              and OpioidAntagonistGiven.dosage.route in "Routes of Administration for Opioid Antagonists"
          )
        return EncounterWithQualifyingAge
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR Numerator
    define "Numerator":
      "Encounter with Non Enteral Opioid Antagonist Administration Outside of Operating Room and within 12 Hrs After Opioid"
    Library Name Name
    SupplementalDataElements SDE Payer
    define "SDE Payer":
      [Coverage: type in "Payer Type"] Payer
        return {
          code: Payer.type,
          period: Payer.period
        }
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR SDE Payer
    define "SDE Payer":
      SDE."SDE Payer"
    Library Name Name
    SupplementalDataElements SDE Ethnicity
    define "SDE Ethnicity":
      Patient.ethnicity E
        return Tuple {
          codes: { E.ombCategory } union E.detailed,
          display: E.text
        }
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR SDE Ethnicity
    define "SDE Ethnicity":
      SDE."SDE Ethnicity"
    Library Name Name
    SupplementalDataElements SDE Race
    define "SDE Race":
      Patient.race R
        return Tuple {
          codes: R.ombCategory union R.detailed,
          display: R.text
        }
    Library Name Name
    HospitalHarmOpioidRelatedAdverseEventsFHIR SDE Race
    define "SDE Race":
      SDE."SDE Race"
    Library Name Name
    CQMCommon HospitalizationWithObservation
    /*
    @description: Hospitalization with Observation returns the total interval from the start of any immediately prior emergency department visit through the observation visit to the discharge of the given encounter
    @deprecated: This function is deprecated. Use the fluent function `hospitalizationWithObservation()` instead.
    */
    define function "HospitalizationWithObservation"(TheEncounter Encounter ):
      TheEncounter Visit
      		let ObsVisit: Last([Encounter: "Observation Services"] LastObs
      				where LastObs.status = 'finished'
                and LastObs.period ends 1 hour or less on or before start of Visit.period
      				sort by end of period
      			),
      			VisitStart: Coalesce(start of ObsVisit.period, start of Visit.period),
      			EDVisit: Last([Encounter: "Emergency Department Visit"] LastED
      				where LastED.status = 'finished'
                and LastED.period ends 1 hour or less on or before VisitStart
      				sort by end of period
      			)
      		return Interval[Coalesce(start of EDVisit.period, VisitStart), end of Visit.period]
    Library Name Name
    CQMCommon GetLocation
    /*
    @description: Returns the Location resource specified by the given reference
    @deprecated: This function is deprecated. Use the fluent function `getLocation()` instead.
    */
    define function "GetLocation"(reference Reference ):
      singleton from (
        [Location] L where L.id = reference.reference.getId()
      )
    Library Name Name
    QICoreCommon getId
    /*
    @description: Returns the tail of the given uri (i.e. everything after the last slash in the URI).
    @comment: This function can be used to determine the logical id of a given resource. It can be used in
    a single-server environment to trace references. However, this function does not attempt to resolve
    or distinguish the base of the given url, and so cannot be used safely in multi-server environments.
    */
    define fluent function getId(uri String):
      Last(Split(uri, '/'))
    Library Name Name
    FHIRHelpers ToConcept
    /*
    @description: Converts the given FHIR [CodeableConcept](https://hl7.org/fhir/datatypes.html#CodeableConcept) value to a CQL Concept.
    */
    define function ToConcept(concept FHIR.CodeableConcept):
        if concept is null then
            null
        else
            System.Concept {
                codes: concept.coding C return ToCode(C),
                display: concept.text.value
            }
    Library Name Name
    FHIRHelpers ToString
    define function ToString(value uri): value.value
    Library Name Name
    FHIRHelpers ToCode
    /*
    @description: Converts the given FHIR [Coding](https://hl7.org/fhir/datatypes.html#Coding) value to a CQL Code.
    */
    define function ToCode(coding FHIR.Coding):
        if coding is null then
            null
        else
            System.Code {
              code: coding.code.value,
              system: coding.system.value,
              version: coding.version.value,
              display: coding.display.value
            }