Patient-safety advocates issue call for regulation

The late Wilbur Cohen, one of Medicare's chief architects, noted it wasn't a glitch that prevented the federal program from policing the practice of medicine, including its safety and quality. Rather, that was a design feature.

“Sponsors of Medicare, including myself, had to concede in 1965 that there would be no real controls over hospitals and physicians,” Cohen said. “I was required to promise before the final vote ... that the federal agency would exercise no control.”

Nearly a half century after Medicare's founding and 15 years after the Institute of Medicine's landmark report “To Err Is Human” ignited concerns about patient safety, the nation still doesn't have an effective set of regulations to protect people once they have entered the healthcare delivery system. Medicare's watchdog, HHS' Office of the Inspector General, recently said adverse events in hospitals contribute to about 15,000 deaths a month, and another 134,000 less-severe injuries.

And that's only an estimate, since state and federally mandated recordkeeping is spotty and hospitals' internal reporting systems capture only 13% of events, according to an inspector general report. And when patients complain, their concerns often end in bureaucratic paper trails and staff-training videos shown in hospital conference rooms, a troubling response in today's fiscal environment, as unnecessary medical errors add billions of dollars annually to healthcare spending.

The lack of progress has led many safety advocates to call for more aggressive regulatory actions by the government, which picks up half the national healthcare tab. “We need the health equivalent of the Federal Aviation Administration, which sets the rules and then enforces them. And then the National Transportation Safety Board, which investigates accidents,” said Dr. Lucian Leape, the influential Harvard professor and an institute chairman at the National Patient Safety Foundation. “We need to have that in healthcare, and I don't see that happening.”

Related Content Tackling patient-safety complaints, improving outcomes, among topics to be discussed at Modern Healthcare's June 18 virtual conference. Register here.
Dr. Atul Gawande, the Boston Brigham & Women's Hospital surgeon and influential health-policy author, said the nation needs an organization with broad investigation capability to pinpoint poor outcomes. “I think that's fundamentally important, as a starting point,” he said.

Even Anthony Tersigni, president and CEO of the $17 billion hospital system Ascension Health, said the day has come for providers to admit they are not perfect and get behind a national system of public accountability. “I completely support fully disclosing the good and the bad within the system, and I would support a national system of public disclosure of hospital adverse events,” he said. (See editorial, p. 28.)

Most hospitals today are pursuing plans to improve patient safety. The phrase “culture of safety” crosses the lips of nearly every hospital official who speaks about the topic.

Hospitals are required to do root-cause analyses of serious failures. Some hospitals are working in public-private partnerships with quality-of-care groups called hospital engagement networks to spread best practices and improve care systematically.

Medicare has also put federal payment policy in play, tying reimbursement to the overall quality of care. Threats from Medicare to dock payments for quality problems such as readmissions and high rates of healthcare-acquired infections have led to some improvements.

Last month, HHS published data showing what it called “historic” improvements in hospital-care quality between 2010 and 2012, including declines in adverse drug events, falls and infections. All told, the improvements in that timeframe prevented 15,000 deaths in hospitals and saved $4.1 billion in costs.

However, these improvements are only a start, patient-safety advocates say. Patient complaints and adverse events are still falling through gaps in the regulatory system, which often operates in secret.

“Many patients try to report them, but they go into a black hole,” said Rosemary Gibson, a senior adviser at the Hastings Center and co-author of the pioneering 2003 medical-error book, “Wall of Silence.” “Hospitals vastly underreport patient harm. Most ignore it or cover it up. There is no safety oversight system in this country.”

The often opaque response to patient-safety complaints has led the families of many injured or deceased patients to turn to the courts after an injury occurs.

Yet malpractice lawsuits usually offer cold comfort at best. “The problem with the malpractice approach is that it is not aimed at healing, but at getting damages. The lawyer's fee depends on how much damages he can get,” said Dr. Stephen Jencks, who formerly worked in patient-safety programs at the CMS and was assistant U.S. surgeon general when he retired. “This is not the way to get healing.”

The hospital accreditation process, run by the hospital-funded Joint Commission, has also failed to make a major dent in the problem, even though it claims to aggressively monitor patient-safety problems and complaints. State health departments, which inspect hospitals on behalf of Medicare, can issue fines or even strip licenses in extreme cases, but it rarely happens. Medicare even has an NTSB-style entity—or rather, a constellation of agencies known as quality improvement organizations (QIOs)—that are designed to deploy independent doctors to investigate patient complaints and assess the standard of care.

This diffuse system is widely seen as a failure. Just last month the CMS formally began restructuring its QIO contracts to remove conflicts of interest, and make the groups more responsive to patient concerns, a long-delayed response to a critical 500-page assessment of the program put out by the Institute of Medicine in 2006.

“There is immense political pressure to afford (healthcare providers) robust procedural protections before imposing sanctions,” University of Michigan law professor and health policy scholar Nicholas Bagley wrote last year in the Georgetown Law Journal. “In the absence of a coherent constituency pushing for a streamlined sanctions scheme, Congress has bowed to that pressure. The resulting process for sanctioning providers is arcane and cumbersome, even by Medicare standards.”

Providers have their own complaints about the oversight system. Hospital groups complain that the decisions to survey hospitals for patient complaints and then document deficiencies seem arbitrary and vary greatly from state to state. “We have urged CMS to really standardize their approach here,” said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association.

Even CMS officials acknowledge their inspection process contains problems. Responding to an especially egregious case, CMS Chief Medical Officer Dr. Patrick Conway noted “our complaint-investigation process appears not to have functioned as intended.”

Conway vowed to revitalize the QIOs. “The quality of care review is essential to ensure care delivered to all beneficiaries meets professionally recognized standards,” he said.

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