November of this new year will mark the 20th anniversary of To Err Is Human, the first of two landmark Institute of Medicine reports castigating the nation's hospitals and physicians for unnecessary lapses in safety and quality.
The initial book-length study estimated medical errors claimed 98,000 lives a year. The second, Crossing the Quality Chasm, laid out a detailed road map for providers to improve the quality of care.
After nearly two decades of concerted efforts, it's time for the National Academies to judge whether quality and safety have improved and where new work is needed most.
Exhibit A on the need for a new report: a shocking study published last month in JAMA. It claimed Medicare's hospital readmissions reduction program caused a statistically significant increase in mortality among patients with heart failure and pneumonia—two of the three conditions initially covered by the program.
The authors suggested that CMS penalties for excessive 30-day readmissions had led hospitals to stint on post-discharge care. They went so far as to claim in a New York Times op-ed that the program may have cost 10,000 seniors their lives, a conclusion that's diametrically opposite of a recent Medicare Payment Advisory Commission report. An accompanying editorial called on Congress and the CMS to immediately revise the program.
The readmissions program isn't the only quality-and-safety incentive program to come under fire in recent years. Rewards and penalties based on quality measures have been under attack for their excess focus on processes, not outcomes. Penalties for hospital-acquired infections have been lambasted for undermining the finances of safety-net facilities with poorer, sicker clientele.
Yet if one steps back from the Sturm und Drang over individual programs, there's evidence to suggest hospitals have made substantial progress in the post-Quality Chasm era. Although the decline has stalled in recent years, overall hospital mortality fell 27% between 2000 and 2015. Among the Medicare-eligible population, it fell 33%, according to data from the Agency for Healthcare Research and Quality.
The Centers for Disease Control and Prevention recently analyzed progress on preventing hospital-acquired infections over the past decade. It found large reductions in central line-associated blood stream infections, catheter-associated urinary tract infections and surgical site infections.
The battle isn't over, of course. One in 31 hospital patients still gets at least one healthcare-associated infection. “There is much more work to be done,” the CDC concluded. That's why a wide-ranging, objective analysis of where things now stand, what works and what doesn't is in order. Post hoc analyses like the JAMA study, which identified an association between a single penalty and negative outcomes, may be missing underlying trends driving the data. As statisticians like to say, correlation is not causation.
For instance, between the pre- and post-penalty periods, there was a sharp decline in overall hospital admissions for heart failure, heart attacks and pneumonia. There were also marked changes in the co-morbidities of the admitted patients. The number of hospitalized patients with dementia was cut in half in the post-penalty period.
Moreover, the number with respiratory difficulties nearly doubled and those with kidney failure increased by 50% to 1 in 5 admissions. While the authors adjusted their data for disease severity and hospice use, even they recognized that the nation's changing attitudes and directives on end-of-life care may have influenced who gets admitted or readmitted to the hospital and, therefore, the outcomes.
That's why we need a study that looks at quality-and-safety progress as a whole and brings that context to its analysis of individual programs.
One final thought on how to structure such a review. Both the editorialist and the corresponding author of the JAMA study worked as consultants for companies that make drugs and devices to treat the studied conditions. The new evaluators must be completely free of conflicts of interest.