Hospital Harm - Opioid-Related Adverse Events
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| Measure Information | 2024 Reporting Period | 2025 Reporting Period |
|---|---|---|
| Title | Hospital Harm - Opioid-Related Adverse Events | Hospital Harm - Opioid-Related Adverse Events |
| CMS eCQM ID | CMS819v2 | CMS819v3 |
| Short Name |
HH-ORAE |
HH-ORAE |
| CBE ID* | 3501e | 3501e |
| Measure Steward | Centers for Medicare & Medicaid Services (CMS) | Centers for Medicare & Medicaid Services (CMS) |
| 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 |
This measure assesses the number of inpatient hospitalizations for patients age 18 and older who have been administered an opioid medication outside of the operating room and are subsequently administered a non-enteral opioid antagonist outside of the operating room within 12 hours, an indication of an opioid-related adverse event |
| Measure Scoring | Proportion measure | Proportion measure |
| Measure Type | Outcome | Outcome |
| Stratification |
None |
None |
| Risk Adjustment |
None |
None |
| 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, 2022). 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, 2021). Patients who experience this event have been noted to have 55% longer lengths of stay (LOS), 47% higher costs, 36% higher risk of 30-day readmission, and 3.4 times higher payments than patients without these adverse events (Kessler et al., 2013). 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 (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, 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. Nearly 5% of hospitalized patients experience an ADE, making them one of the most common types of inpatient errors (https://psnet.ahrq.gov/primer/medication-errors-and-adverse-drug-events, 2019). 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. |
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 length of stay (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 (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. 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. Data are lacking on use of Nalmefene for reversal of overdose due to fentanyl or its analogues. For emergent reversal of opioid overdose, Naloxone is a safer choice (Med Lett Drugs Ther, 2022). 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 (https://cpr.heart.org/-/media/cpr-files/cpr-guidelines-files/highlights/hghlghts_2020_ecc_guidelines_english.pdf). |
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. The 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 (American Heart Association, 2020). In February 2022, the Food and Drug Administration (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 (FDA, 2023). |
| Improvement Notation |
A lower proportion indicates higher quality |
A lower measure score indicates higher quality |
| Definition |
This measure defines the indication of a harm for an opioid-related adverse event by assessing administration of an opioid antagonist. Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other. |
This measure defines the indication of a harm for an opioid-related adverse event by assessing administration of an opioid antagonist. Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other. |
| Guidance |
To calculate the hospital-level measure result, divide the total numerator events by the total number of qualifying encounters (denominator). Qualifying encounters (denominator) include all patients 18 years of age or older 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 only 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 antagonist 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 version of the eCQM uses QDM version 5.6. Please refer to the eCQI resource center https://ecqi.healthit.gov/qdm) for more information on the QDM. |
Qualifying encounters (denominator) include all patients 18 years of age or older 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 antagonist 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 version of the eCQM uses QDM version 5.6. Please refer to the eCQI resource center https://ecqi.healthit.gov/qdm) for more information on the QDM. |
| Initial Population |
Inpatient hospitalizations for patients age 18 and older during which at least one opioid medication was administered outside of the operating room |
Inpatient hospitalizations that end during the measurement period for patients age 18 and older and at least one opioid medication administration starts during the hospitalization outside of the operating room |
| Denominator |
Equals Initial Population |
Equals Initial Population |
| Denominator Exclusions |
None |
None |
| Numerator |
Inpatient hospitalizations where an opioid antagonist was administered outside of the operating room and within 12 hours following administration of an opioid medication. 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. |
Inpatient hospitalizations where a non-enteral opioid antagonist administration starts during the hospitalization outside of the operating room and 12 hours or less 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. |
| Numerator Exclusions |
Not applicable |
Not Applicable |
| Denominator Exceptions |
None |
None |
| Next Version | No Version Available | |
| Previous Version | No Version Available |
Additional Resources for CMS819v2
Header
Removed duplicative statement regarding opioid antagonist administration in the operating room from the description as it is already in the guidance.
Measure Section: Description
Source of Change: Measure Lead
Updated grammar, wording, and/or formatting to improve readability and consistency.
Measure Section: Description
Source of Change: Annual Update
Updated copyright.
Measure Section: Copyright
Source of Change: Annual Update
Updated disclaimer.
Measure Section: Disclaimer
Source of Change: Annual Update
Updated the rationale to reflect recent evidence supporting the importance of the measure.
Measure Section: Rationale
Source of Change: Measure Lead
Updated the Clinical Recommendation Statement to reflect current evidence.
Measure Section: Clinical Recommendation Statement
Source of Change: Measure Lead
Updated references.
Measure Section: Reference
Source of Change: Measure Lead
Revised the Initial Population narrative to clarify that only opioid medications administered outside of the operating room (OR) will be evaluated.
Measure Section: Initial Population
Source of Change: Measure Lead
Revised the Initial Population narrative to reflect the updated age anchor to 18 years and older at the start of the inpatient hospitalization to harmonize with other hospital measures.
Measure Section: Initial Population
Source of Change: Measure Lead
Revised the narrative to clarify the route of administration of the opioid antagonist must be by intranasal spray, inhalation, intramuscular, subcutaneous, or intravenous injection in order to be evaluated for the numerator.
Measure Section: Numerator
Source of Change: Measure Lead
Revised the narrative to remove 'Naloxone' when describing the opioid antagonists since it is no longer the only opioid antagonist medication in the measure.
Measure Section: Multiple Sections
Source of Change: Measure Lead
Logic
Revised the age anchor to 18 years and older at the start of the inpatient hospitalization to harmonize with other hospital measures.
Measure Section: Initial Population
Source of Change: Measure Lead
Revised the definition name to align with logic content.
Measure Section: Initial Population
Source of Change: Measure Lead
Updated the Initial Population to exclude events where the opioid medication was given in the operating room.
Measure Section: Initial Population
Source of Change: Measure Lead
Updated the Numerator definition to only evaluate opioid antagonists given by a non-enteral (i.e., intravenous, intramuscular, subcutaneous, intranasal, inhalation) route. Revised the definition name to align with logic content.
Measure Section: Numerator
Source of Change: Measure Lead
Updated the names of CQL definitions, functions, and/or aliases for clarification and to align with the CQL Style Guide.
Measure Section: Definitions
Source of Change: Standards/Technical Update
Value Set
The VSAC is the source of truth for the value set content, please visit the VSAC for downloads of current value sets.
Added nalmefene as a new type of opioid antagonist medication to the value set Opioid Antagonist (2.16.840.1.113762.1.4.1248.119) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead
Added value set Routes of Administration for Opioid Antagonists (2.16.840.1.113762.1.4.1248.187) based on change in measure requirements/measure specification.
Measure Section: Terminology
Source of Change: Measure Lead
Value set Opioids, All (2.16.840.1.113762.1.4.1196.226): Added 19 RxNorm codes based on review by technical experts, SMEs, and/or public feedback. Deleted 153 RxNorm codes based on terminology update.
Measure Section: Terminology
Source of Change: Measure Lead
Value set Opioid Antagonist (2.16.840.1.113762.1.4.1248.119): Added 2 RxNorm codes (199059, 2592953) based on updated evidence in published guidelines, published literature, or from published specialty medical society or group recommendations. Added 1 RxNorm code (2596175) based on terminology update. Deleted 2 RxNorm codes (1191212, 1191228) based on terminology update.
Measure Section: Terminology
Source of Change: Measure Lead
Value set Payer (2.16.840.1.114222.4.11.3591): Added 5 SOP codes (1111, 1112, 142, 344, 141) based on review by technical experts, SMEs, and/or public feedback.
Measure Section: Terminology
Source of Change: Measure Lead