25% of Medicare patients suffer clinical harm in the hospital, OIG report indicates

One step in addressing in-hospital patient harm would be to improve CMS’s Hospital-Acquired Condition Reduction Program, but a proposal to suppress HAC-related data is in the works for FY23.

A quarter of Medicare patients experienced harm while being treated in hospitals during a single month in 2018, according to a new report from the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS).

Of patients who experienced harm, 23% required treatment that resulted in additional Medicare costs, the report found. Extrapolating that rate to all Medicare patients, OIG said additional costs probably totaled “hundreds of millions of dollars” for the month in question.

“HHS leadership and agencies must work with urgency to reduce patient harm in hospitals,” OIG wrote.

Rates of patient harm

OIG reviewed medical records for a random sample of 770 Medicare patients who were discharged from acute care hospitals in October 2018. In that pool, 12% were found to have experienced adverse events: issues that led to longer hospital stays, permanent harm, life-saving interventions or death.

In addition, 13% of cases fell under the category of temporary harm events: those that required intervention but did not lead to lasting harm, prolonged hospital stays or the need for life-sustaining measures.

The issues that led to harm events generally involved medication (43% of events), patient care (23%), procedures and surgeries (22%) or infections (11%).

However, fewer than half of harm events were considered preventable based on a review by physicians who helped with the study. Specifically, 43% of events were deemed preventable, most frequently because of substandard or inadequate care, while in all likelihood nothing could have been done about the remaining cases due to issues such as the complexity of the patient’s condition.

If only preventable events were calculated in the study results, the harm rate would have been 13%, including 6% for adverse events and 7% for temporary events.

A continuing area of concern

The rate of harmful events is slightly down from October 2008 data, which OIG examined for a 2010 study. That analysis found a harm rate of 27%.

In its response to the new report, CMS questioned whether changes in the Medicare population during the ensuing 10 years were accounted for in the review.

“The prevalence of comorbidities is rising in the Medicare population, and Medicare patients are being treated for more clinically complex conditions and diagnoses than in the past,” the agency stated in a letter signed by Administrator Chiquita Brooks-LaSure.

OIG responded that such differences make direct comparisons between the two reports difficult but don’t detract from the relevance of the latest findings in isolation.

Potential regulatory approaches

During the decade between the data reviewed for the two reports, CMS introduced the Hospital-Acquired Condition (HAC) Reduction Program as an additional incentive for hospitals to emphasize patient safety. Hospitals that rank in the worst-performing quartile for rates of HACs can be penalized 1% of their annual Medicare payments.

OIG’s assessment suggests the program has only a small impact.

“Because the policies use narrowly scoped lists of HACs and employ specific criteria for counting harm events, they have limited effectiveness in broadly promoting patient safety,” the report states.

Only 5% of harm events seen in the study were included in the HAC Reduction Program and only 2% on the Deficit Reduction Act (DRA) HAC List, which prevents hospitals from receiving additional payment for cases in which a condition on the list occurred but was not present at admission.

Among its recommendations for CMS and the Agency for Healthcare Research and Quality, OIG said the HAC Reduction Program and DRA List should be expanded to “capture common, preventable and high-cost harm events.” The former hasn’t been updated since 2017 and the latter since 2013.

CMS agreed with the recommendation and said it would consider additions to the HAC Reduction Program through the annual regulatory process for Medicare inpatient payments. Conditions also can be addressed through the Hospital Inpatient Quality Reporting (IQR) Program, including via the addition of two medication-related adverse-event electronic clinical quality measures (eCQMs) related to glycemic management starting in 2023.

Relevant measures currently under consideration for the HAC Reduction Program and/or the IQR Program include:

• Healthcare-associated clostridioides difficile infection outcomes
• Hospital-onset bacteremia and fungemia outcomes
• Opioid-related adverse events
• Severe obstetric complications

Concern over temporary changes to the HAC

Leapfrog Group, the patient safety advocacy organization, expressed disappointment that CMS has proposed to suppress the PSI 90 composite score in calculations of HAC scores for FY23 as an accommodation for the pandemic’s impact on hospital clinical operations. Performance in the PSI 90 likewise wouldn’t be publicly reported during the coming fiscal year.

 “These dangerous complications, such as sepsis, kidney harm, deep bedsores and lung collapse, are largely preventable yet kill 25,000 people a year and harm 94,000,” Leapfrog Group stated.  “Data on these complications is not available to the public from any other source [aside from PSI 90 scores]. If CMS suppresses this data, all of us will be in the dark on which hospitals put us most at risk, yet we all shoulder the burden of these dangerous preventable complications.”