CMS Increases Momentum of EHR-based Hospital Harm Direction

The Center for Medicare and Medicaid Services (CMS) recently released the FY2023 Inpatient Prospective Payment System (IPPS) Proposed Rule governing payment for the inpatient setting.  Just as CMS foreshadowed last summer in the FY22 IPPS Final Rule, they released yet another EHR-based hospital harm measure targeting opioid-related events. The new proposed EHR-based hospital harm measure is the opioid-related event eCQM measure (NQF #3501e).

The significance is two-fold.  First, this continues CMS’ already-announced release of EHR-based hospital harm measures. This action unmistakably shifts the regulatory regime from claims-based to EHR-based measurement with respect to patient safety. CMS began promulgating EHR-based hospital harm measures last summer in the FY2022 Final Rule.  These measures, unlike the traditional claims-based PSI 90, use data elements from the EHR to identify potential harm – which have also been called “triggers” by those who for many years have developed and published on this method — one which has been validated and for which evidence has been mounting for decades.[1] A selection of citations includes:  Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA. 1991 Nov 27;266(20):2847-51.Resar RK, … Continue reading

Second, this regulatory direction will allow hospitals interested in improving patient safety to use the same measure, workflow, and systems to accomplish two objectives at once for the first time:  invest resources in compliance that — given that compliance activity can often be at odds with operational activity — at the same time can improve safety and quality outcomes. Historically, patient safety and quality programs often have been forced privately to make a tough decision — due to resource constraints — to focus on regulatory compliance (a must) at the cost of improving clinical outcomes for which there is insufficient organizational energy and funding.

Therefore, this release of yet another EHR-based hospital harm measure heralds the advent of the opportunity to do both in an integrated program, workflow, and system:  comply with the adverse event regulation while going upstream to improve outcomes.

Proposed Opioid-Related Adverse Events eCQM (NQF #3501e)

Let’s take a deeper dive by unpacking the proposed rule with respect to the opioid-related events. Key reasons and context provided by CMS for the new measure include:

  • Opioids are among the most frequently occurring adverse drug events (ADEs) among hospital patients 
  • Opioid-related adverse events both harm the patient and result in negative financial impact
  • The most serious opioid-related adverse events (AEs) include those involving respiratory depression, which can lead to brain damage and death
  • Patients suffering from opioid-related AEs have 55% longer lengths of stay, 47% higher costs, 36% higher risk of 30-day readmission, and 3.4 times higher payments than patients without these adverse events — which the largest payor is now targeting
  • While acknowledging limited data, The Joint Commission suggested that “opioid-induced respiratory arrest may contribute substantially to the 350,000 to 750,000 in-hospital cardiac arrests annually”

The proposed measure is an outcome measure based on the opioid-related AEs occurring during a hospital patient stay by assessing the administration of naloxone (often referred to as “narcan”).  Narcan is “a lifesaving emergent therapy with clear and unambiguous applications in the setting of opioid overdose.”

CMS states that the purpose of this measure is for hospitals to “track and improve their monitoring and response to patients administered opioids during hospitalization.”  The goal is to avoid harm, “such as respiratory depression, which can lead to brain damage and death.” In addition, they clarify that the measure’s intention is to focus on inpatient opioid-related AEs and not opioid-related events that happen in the community that then the hospital addressed upon e.g. an emergency department admission.  

Opioid-related Harm:  Preventable

CMS makes clear their position, with significant implications for the field:  “Most opioid-related adverse events are preventable.”

Further, they explain[2] Source:  The Joint Commission Sentinel Event database:

  • 47% were due to a wrong medication dose
  • 29% due to improper monitoring
  • 11% due to other causes, e.g. medication interactions and/or drug reactions)

In addition, in a review of cases from a malpractice claims database “in which there was opioid-induced respiratory depression among post-operative surgical patients”:

  • 97% of these adverse events were judged preventable with better monitoring and response.

CMS continues:  “While hospital quality interventions such as proper dosing, adequate monitoring, and attention to potential drug interactions that can lead to overdose are key to prevention of opioid-related adverse events, the use of these practices can vary substantially across hospitals.” 

Opioid administration varies widely by hospital, ranging from 5% in the lowest-use hospital to 72% in the highest-use hospital. CMS’s measure developer found that hospitals using opioids most frequently have increased adjusted risk of severe opioid-related adverse events.

What This Means

The implications for health systems are many.  Three key takeaways include:

  • AE Monitoring — Future Requirement?  With almost one-third of opioid-related events due to inadequate monitoring, the standard of care in the field is likely to require monitoring of AEs in the future, as opposed to the fragmented, inconsistent, and non-systematic manner in which AEs are identified and tracked today in most hospitals;
  • Data Consistency — Standardization Opportunity.  Variance in practice across hospitals is likely to result in not only standardization of practices and implementation but also going upstream to standardize upon and harmonize definitions, administration, and protocols in the event of responding to an opioid-related event;
  • Operational  Integration — Comply & Improve.  Instead of managing compliance in one “silo” and improving outcomes in another, this measure ushers in the possibility to eliminate duplication by  integrating both compliance fulfillment and also outcomes improvement efforts in an integrated system of goals, processes, workflows, and technology.  


1  A selection of citations includes:  Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA. 1991 Nov 27;266(20):2847-51.Resar RK, Rozich JD, Simmonds T, Haraden CR. A trigger tool to identify adverse events in the intensive care unit. Jt Comm J Qual Patient Saf. 2006 Oct;32(10):585-90. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010 Nov; Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, James BC. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-9. U.S. Department of Health and Human Services, Office of Inspector General. Hospital Incident Reporting Systems Do Not Capture Most Patient Harm, Daniel R. Levinson, Inspector General. January 2012.
2 Source:  The Joint Commission Sentinel Event database