Disclosing Medical Errors: In Law and In Practice

While nobody expects a medical error, one in four patients on Medicare will experience some type of preventable harm or “adverse event” while hospitalized and one in ten will acquire an infection during their stay.1,2 Among Medicare patients, the U.S. Department of Health and Human Services Office of the Inspector General (HHS OIG) estimated that costs associated with adverse events totaled $324 million for 1 month alone or $4.4 billion per year.1 Nearly half (44 percent) of these adverse events were deemed preventable.

To address these unsettling statistics, President Bush signed the Deficit Reduction Act3 into law in 2006, which, among other things required the HHS to identify Hospital-Acquired Conditions (HAC) that were:

  • High-cost, high-volume, or both;
  • A secondary diagnosis that would make overall care more expensive; or
  • Preventable, if evidence-based guidelines were followed.

In 2008, CMS released a landmark regulation that changed Medicare payment policy by stopping reimbursement to hospitals for making certain mistakes or for their corrective follow-up care.4 Among these errors were “never events,” that can cause serious injury or death to the patient. This list included:

  • Surgery on a wrong body part;
  • Surgery on a wrong patient; and
  • Wrong surgery on a patient.

The CMS policy change was designed to pay providers based on their performance instead of solely paying for volume of services delivered (known as “fee-for-service”). While the development of the HAC policy is a step in the right direction, many have argued that the so-called “high-cost-high-volume” requirement is too narrowly defined and has excluded important procedures that prevent patient death. Examples include failure to rescue when a patient dies because a complication is not recognized in a timely manner or treated appropriately, and failure to detect critical congenital heart disease in newborns.5,6

The need to update this policy to address preventable patient death was among the recommendations included in Patient Safety Movement Foundation Founder Joe Kiani’s testimony before the Senate Health, Education, Labor, and Pensions (HELP) committee in September 2013.,7

President Obama strengthened CMS’ ability to crack down on HACs with the passage of the Patient Protection and Affordable Care Act.8 Starting in 2015 hospitals will face a one percent penalty for HAC, although some in the hospital community are concerned that overlapping federal incentive programs may mute the impact the policy will ultimately have on improving patient safety.9

In addition to financial penalties, hospitals are required to publicly report adverse events on the HAC list. CMS requires disclosure of any event on the list if it was not “present on admission,” meaning the patient acquired the condition because of their hospital stay. Some states have their own reporting requirements that go beyond the Federal-reporting mandate. Minnesota was the first state to pass public reporting legislation and require hospitals to report on 29 different types of adverse events to the Minnesota Department of Health.10

While there has been extensive legal and regulatory activity about how doctors and hospitals must report or are paid in the event of a preventable medical error, there is no law governing how these errors should be disclosed to patients or their families.

Some healthcare institutions have sought to hide adverse events to limit exposure to penalties or malpractice lawsuits. This was the case with actress and patient advocate Alicia Cole who was diagnosed with multiple HACs, including necrotizing fasciitis, after a routine fibroid procedure. The hospital attempted to hide evidence that the infections were acquired at its institution and was later cited for violation of five state laws and 10 federal laws for patient safety, infection control, and unsanitary conditions in its operating rooms.


Watch Alicia Cole share her experience

Other hospitals, however, have taken a more proactive role in how they approach an adverse event. MedStar Health, based in Maryland, which is represented on the Patient Safety Movement Board of Directors, has implemented a program that emphasizes transparency. In the case of a preventable medical error, representatives from the hospital apologize to the family within 30 minutes, the patient is not charged for any of their care–or subsequent care–until they are fully recovered, and a root-cause analysis is performed to ensure the event never happens again.

Patient and family experiences after an adverse event can vary dramatically. The Patient Safety Movement wants to spur leaders in healthcare to action by creating a platform for storytelling and shared learning.