Quality Improvement or Unintended Consequences?*

Ongoing improvement in the quality of care is an important and essential goal for the healthcare system. Reporting of outcome measures, such as 30-day postoperative mortality, is a common measure used by medical societies, collaborative quality improvement programs, and regulatory agencies as one tool to improve quality and transparency. However, concern is often raised about the possible unintended consequences of many policies or regulations. Of particular concern to critical care is the potential for inappropriate prolongation of life, with limited or no benefit to the patient, to meet the 30-day survival goal (1,2). Although such unintended consequences remain unconfirmed (3,4), a potential decrease in the willingness of cardiac surgeons to operate on high-risk patients has been identified as an unintended effect of the public reporting of 30-day postoperative mortality (5). Although the validity of the 30-day mortality rate as a quality indicator has been questioned as it does not capture all surgical mortalities (6–8), 30-day postoperative mortality remains a widely used quality measure in surgical patients.

Regulations whose compliance is linked to increases in reimbursement are common as they have been shown to be effective in altering physician and hospital behavior (9). The Medicare Access and Children’s Health Insurance Program Reauthorization Act (MACRA) was passed in 2015 with the goal of incentivizing quality improvement through reimbursement tied to reporting of quality measures (10). Indeed, some outcomes have been shown to improve following the implementation of MACRA (11).

In this issue of Critical Care Medicine, Olanepikun et al (12) report their study using the National Inpatient Sample (NIS) database to investigate an association between the implementation of MACRA and 30-day postoperative mortality, with palliative care consultation being the secondary outcome. The authors compared mortality on postoperative day (POD) 1–30 with that during POD 31–60 (primary outcome), as well as palliative care consultations for those intervals, in the pre-MACRA period of 2011–2014 compared with the post-MACRA period of 2016–2019. Patients who underwent one of 19 standard major surgical procedures on the first hospital day comprised the study population (3), and daily mortality hazard rates were calculated to compare changes in mortality pre-POD-30 versus post-POD-30. The authors also compared mortality on POD 31–35 with that on POD 26–30 for both time periods. Nearly 5 million patients were included in this study, 2.1 million pre-MACRA and 2.8 million post-MACRA. There were some differences in demographics between the two groups, and in the aggregate, there was a higher burden of comorbidities in the post-MACRA cohort as measured by the Charlson comorbidity score. Although mortality increased in both groups over the 60-day period, there was no difference in mortality between the pre-MACRA and post-MACRA groups on days 31–35 compared with days 26–30. However, the authors also found a significant increase in palliative care consults over time, with a marked increase after 30 days in both cohorts, with a greater increase in the rate of palliative care consults on days 31–60 in the post-MACRA cohort when compared to the pre-MACRA cohort over the same POD interval.

The authors have provided us with a thoughtful study, raising concerns that are important to critical care clinicians. The greatest strength of this study is the large number of patients included. However, while the NIS database does not allow the comparison of different hospitals nor changes in the same hospital over time, the large number of patients analyzed makes it unlikely that any single hospital or group of hospitals could drive the data to a misleading conclusion. Other quality measures that were active and may have influenced clinical care over this time period may represent confounding factors, weakening the conclusions one can draw. The authors provide a thorough discussion of the limitations of their study.

The authors suggest that the greater increase in palliative care consults post-MACRA may represent an indicator of a delay in initiating goals of care discussions as a potential unintended consequence of MACRA. Although this concern is important and merits our attention, the data presented support an alternative explanation for the noted increase in palliative care consults post-MACRA. The recognition of the importance of palliative care in critically ill patients increased over the time period encompassing this study resulting in a general increase in palliative care consults. In fact, Figure 3 (12) in the article shows the greatest increase in palliative care consults during days 50–60 in both groups, arguing against a delay in consults related to a 30-day mortality measure. This study does not allow us to determine the reasons for increased palliative care consults post-MACRA. The authors suggest that one way to address the reason for increased palliative care consults after 30 days would be to interview the stakeholders regarding the rationale and timing for the palliative care consult, a reasonable research approach that could only be done in a much smaller number of patients and providers but that could provide useful information. They further suggest that palliative care be considered for integration into MACRA as a quality measure, perhaps including preoperative consultation. There is documented variability in the availability of palliative care across hospitals, with greater availability in not-for-profit and metropolitan hospitals compared to private and rural hospitals (13). Palliative care has been shown to be underutilized in a cardiac surgery population, a finding that is likely true in other critical care settings (14). Adding palliative care consultation to the MACRA measures might improve the availability of palliative care more broadly.

The analysis of the POD 31–35 versus POD 26–30 cohorts is particularly important as it focuses on the specific time period of concern. The lack of a mortality difference between the pre-MACRA and post-MACRA groups, especially in the POD 31–35 versus POD 26–30 cohorts, is reassuring that the issuing of the MACRA regulations did not routinely reduce the incidence of palliative care consultation and end-of-life decision-making. In fact, as the overall mortality was lower in the post-MACRA group despite more comorbidities and potentially sicker patients, one might have anticipated palliative care consultations to be fewer in the post-MACRA cohort. An increase in palliative care consultation is likely a good thing but delaying goals of care discussions and palliative care consults until after 30 days in response to regulations affecting reimbursement would be neither appropriate nor desirable. The authors raise this question, and it is certainly one we should all think about, but this study cannot answer it. The increase in palliative care consults after the implementation of MACRA is an improvement in quality, but not likely one that is related to the specific regulations. The issue of unintended consequences of changes in reimbursement intended to improve the quality of care remains important and deserves clinician awareness, consideration, and further research.

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