First do no harm: Can eCQMs hurt patients?

The Hippocratic Oath has been in existence since anywhere from 200-500 AD. One translation (which has been modified in a version with which we are more familiar) states:

“I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing. Neither will I administer a poison to anybody when asked to do so, nor will I suggest such a course…Into whatsoever houses I enter, I will enter to help the sick, and I will abstain from all intentional wrong-doing and harm…”

In light of the above text, how much quality measures have improved patient care and outcomes has been hotly debated. Note it has been 20 years since publication of “To Err is Human” by the Institute of Medicine and many have questioned how far we have come in reducing medical errors since its publication and spotlight on preventable medical errors. But there has not been nearly enough discussion about quality measures actually causing harm.

I have previously discussed the FY 2020 finalized and proposed electronic Clinical Quality Measures (eCQMs). All of the existing and new eCQMs (Safe Use of Opioids and the new Hybrid Hospital All-Cause Readmission measure) as well as the three proposed and not finalized (severe hypoglycemic events, rate of C-sections for nulliparous women with single vertex presentation, and pressure injuries) have one thing in common: they are all process measures. This means that a hospital must report on the number of patients qualifying for reporting per the criteria for the eCQMs (either required or self-selected). These are considered process measures as hospitals are not penalized under the Inpatient Quality Reporting Program (IQR) unless they fail to report. This is also described as “pay for reporting” as compared to “pay for performance.”

There was one additional proposed eCQM that was not finalized.  It is unique, as it is the first outcome eCQM as compared to all of the other eCQMs which are process related. There was a great deal of discussion from NQF and stakeholders in the final rule about this proposed eCQM and whether or not this measure would inadvertently cause harm to patients.

CMS’s rationale for the proposed eCQM includes the following:

• Opioids are among the most frequently implicated medications in adverse drug events among hospitalized patients, with the most serious adverse events including respiratory depression which can lead to brain damage and death.
• Patients with opioid-related adverse events are noted to have 55 percent longer lengths of stay, 47 percent higher costs, 36 percent higher risk of 30-day readmission and 3.4 times higher payments than patients without these adverse events.
• The Joint Commission’s Sentinel Event data base noted in those patients with opioid-related drug events, 47 percent were due to a wrong dose, 29 percent due to improper monitoring and 11 percent due to other causes.
• Hospital interventions including proper dosing, monitoring and attention to potential interactions vary widely across hospitals as well as the quality of opioids administered (anywhere from 5 to 72 percent).

The proposed but not finalized eCQM is the Hospital Harm–Opioid-Related Adverse Events eCQM. Per the Final Rule, this eCQM is designed to reduce adverse events associated with administration of opioids in the hospital setting. The measure is intended to lead to safer care by incentivizing hospitals to track and improve monitoring of patients receiving opioids during their hospitalization. This measure is in alignment with the Meaningful Measures quality priority “Making Care Safer by Reducing Harm Caused in the Delivery of Care” in the area of “Preventable Healthcare Harm.”

The eCQM is not meant to measure preventability, but to assess the overall rate of harm within a hospital by incorporating a definition of harm that is likely to be reduced as a result of hospital best practice. CMS noted they are setting no benchmarks and are also not expecting a zero rate.

The eCQM would be measured by assessing administration of naloxone as an indicator of harm. Naloxone is utilized as a proxy of administration of excessive doses of opioid medications. The measure is not risk-adjusted for chronic opioid use as the standard of care should not be any different and the data element (chronic opioid) use is hard to capture consistently. The data source is entirely EHR data and patient level data submitted by hospitals to CMS.

The numerator is number of patients receiving naloxone outside of the operating room either 1) after 24 hours from hospital arrival or 2) during the first 24 hours after hospital arrival with evidence of hospital opioid administration prior to the naloxone administration. The time period of the first 24 hours after admission was set to reduce hospital reporting burden and the requirement of being after the first 24 hours was to ensure the harm was hospital acquired and not due to an out-of-hospital encounter.

The denominator is all hospitalized patients over age of 18, whether or not they were prescribed an opioid.

This measure was submitted to the National Quality Forum MAP Hospital workgroup and received a recommendation to refine and resubmit in 2017. It was refined by CMS and resubmitted in 2018. NQF re-reviewed and expressed concern that the measure may trigger numerator cases not intended, such as for diagnostic purposes, opioid side effects, or to reverse overdoses caused by administration of opioids that were not hospital-prescribed. NQF also expressed concerns about the denominator being all hospitalized patients as compared to just those being administered opioids by the hospital.  This would result in calculation of very low rates of adverse events. Because of the above concerns, NQF has not endorsed the measure.

Other stakeholders expressed concern that this measure could deter or delay clinically appropriate naloxone administration or result in underprescribing of opioids for pain control when clinically necessary. Concern was also voiced that hospitals may turn to BiPAP or intubation instead of administering naloxone. The stakeholders and CMS noted it would be unethical to withhold administration but were concerned that providers ad institutions may be overly concerned with hospital performance.

A final stakeholder concern was with monitoring only between the first 24 and 48 hours as this would not capture those patients who experienced opioid induced harm beyond the initial time period.

As a final note, stakeholders also made recommendations for potential refinements including:

• Considering multiple doses of naloxone or multiple opioid-related adverse events for the same patient
• Specific thresholds for the administration of naloxone
• Restricting the measure to documented respiratory failure tied to opioid administration and/or then transfer to a higher level of care with IV use

CMS did not indicate the potential next steps for this measure, so stay tuned to see what the future holds for this unique eCQM.

Speaking of doing no harm, the holidays are rapidly approaching. Be kind to yourself and to those around you! Also, view my latest webinar where I discuss the results for FY20 Value Based Purchasing as well as discuss upcoming changes to the program in future years.

Cheryl Manchenton is a senior inpatient consultant and project manager for 3M Health Information Systems.

References

Hippocrates of Cos (1923). "The Oath". Loeb Classical Library. 147: 298–299. doi:10.4159/DLCL.hippocrates_cos-oath.1923. Retrieved 20 November 2020.

Kessler, E.R., Shah, M., Gruschkkus, S.K., et al. (2013). Cost and quality implications of opioid -based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy, 33(4): 383-91.

The Joint Commission. (2012.) Safe Use of Opioids in Hospitals. The Joint Commission Sentinel Event Alert, 49:1-5.