New Fed Policy Would Hide CMS Data on Patient Safety Records of Hospitals

by James C. Sherlock

One of the most disturbing commentaries I have read in a long time relating to federal efforts to improve hospital patient safety reports a major step backwards in that program.

I have written here many times of the power of the hospitals over Virginia’s politics. A proposed new federal rule shows that power at the federal level. It would negatively affect your ability to understand and compare the patient safety records of hospitals.

The Biden administration Centers for Medicare/Medicaid Services (CMS) proposes to hide from the public a CMS rating that helps consumers view relative patient safety grades of hospitals. As important to the hospitals, perhaps, no one would be able to report on that information.

It also proposes to waive $350 million in fines for hospitals that violated existing regulations.

CMS for the Secretary of Health and Human Services is, with this rule, exercising the extraordinary powers the Secretary gives himself by constantly extending the Declaration of Public Emergency for COVID.  And yes, that is legal.

Virginia Hospital and Healthcare Association (VHHA) submitted a 17-page letter of comment. It of course supported the waiver of fines.  On the issue of suppressing patient safety data, the VHHA wrote, unsurprisingly:

“VHHA and its members are supportive of the proposed suppression (of data) in the HVBP program.”

The letter also encouraged CMS to also suppress pneumonia mortality measure because of the potential overlap with COVID- related pneumonia.

The only way that could happen since CMS is already suppressing data with a primary or secondary COVID diagnosis is if there was no reported COVID indication in pneumonia cases.

The proposal itself represents a major scandal.  A total of 1,533 comments, now closed, were submitted on the proposed rule.

They comments from doctors and patient safety groups were unsupportive.  Hospitals were very supportive.  The Virginia Department of Health sent a short letter on the larger rule, but did not comment on data suppression.

The result: political healthcare rules courtesy of the Biden administration and the hospital lobby.

The following article is reprinted by permission of Kaiser Health News.

Feds Want a Policy That Advocates Say Would Let Hospitals Off the Hook for Covid-Era Lapses

The Centers for Medicare & Medicaid Services is responding to the chaos of the covid-19 pandemic by proposing to hide from the public a rating that lets consumers compare hospitals’ safety records and to waive approximately $350 million in financial penalties for roughly 750 hospitals with the worst patient-safety track records.

CMS’ chief medical officer, Dr. Lee Fleisher, said those safety metrics were not designed to properly account for how a pandemic, with its patient surges and workforce shortages, might affect hospital systems.

“Safety, transparency, and quality of care of patients is not enhanced by the use of skewed or inaccurate data, and, in fact, could result in negative consequences for patients,” he said. “CMS wants the public to have complete trust in the data and will make data on quality available when we have a high confidence in its credibility and accuracy.”

But patient safety advocates argue CMS is letting hospitals off the hook for their pandemic performances, and many decried the loss of transparency that suppression of such data would cause.

CMS wants to keep “patients, payers, and insurers in the dark on what happened during the pandemic,” said Patricia Kelmar, director of health care campaigns for the nonprofit U.S. Public Interest Research Group. She added that without penalties, hospitals won’t be forced to change ahead of the next crisis that strains health systems.

“There was no comma in the law that says, ‘Unless there’s a pandemic, you don’t have to pay these penalties,’” Kelmar said.

The proposed rule comes after CMS officials publicly acknowledged in the New England Journal of Medicine  that progress on lowering hospital-acquired infections — such as urinary tract and staph infections, as well as bloodstream infections associated with central lines — has faltered significantly during the pandemic. Also, a May federal report that used data from 2018 found that even before the pandemic, 1 in 4 Medicare patients were harmed in the hospital, with nearly half of such events being preventable.

The Leapfrog Group, a nonprofit patient advocacy group, estimates that more than 24,000 people a year die because of the patient safety issues measured by CMS’ ratings.

The metrics that CMS wants to suppress appear on Medicare’s Care Compare website, formerly known as Hospital Compare. The site allows consumers to view a broad range of quality metrics for hospitals, including mortality and readmission rates. Those scores would continue to appear under the CMS proposal, but the site would not report data from what’s known as the PSI 90, or “Patient Safety and Adverse Events Composite,” including how often patients had serious complications from potentially preventable medical harm, such as falls and sepsis. CMS will publicly release other safety data, although the pandemic has complicated that, too.

The penalties CMS wants to waive are issued annually through the Hospital-Acquired Condition Reduction Program, which was created by the Affordable Care Act. But because the PSI 90 won’t be available and CMS officials are wary of counting some other metrics skewed by the pandemic, they said penalizing hospitals, as they have done in the past, would not be reasonable.

The poorest-performing hospitals would be spared the 1% Medicare payment reductions that CMS would otherwise have applied throughout the upcoming federal fiscal year, which begins Oct. 1. CMS plans to resume the penalties in the following fiscal year, which begins in October 2023.

CMS’ proposal to pause such penalties is reasonable, said Andrew Ryan, a professor of health care management at the University of Michigan’s School of Public Health, who has written extensively on the hospital quality program. He pointed out that the metrics that underlie these financial penalties are easily skewed by variations in patient mix — such as those triggered by covid surges or lockdowns.

But Lisa McGiffert, co-founder of and board president for the Patient Safety Action Network, said she’s tired of hearing hospitals talk about the administrative strain that reporting the data would create and of CMS saying that adjusting how it compares hospitals would be difficult.

“It’s a real burden if you die or lose your mom,” McGiffert said.

A 2021 KHN investigative series detailed the gaps in CMS’ oversight in tracking and holding hospitals accountable for patients who were diagnosed with covid after entering the hospital.

As the pandemic continues, the agency has not added hospital-acquired covid infections to its patient safety quality metrics, Fleisher said. Centers for Disease Control and Prevention spokesperson Martha Sharan said a joint effort of the CDC, CMS, and the National Quality Forum, a nonprofit that aims to improve patient care value, that would establish such metrics “could be a consideration after the emergency phase of the pandemic.”

The U.S. Department of Health and Human Services currently maintains public, aggregated state-by-state reporting of covid-19 hospital-onset data, but, as KHN previously reported, such data does not hold individual hospitals accountable. Patient safety experts say the HHS report is likely an undercount because it tracks only hospital-onset covid cases that appeared after 14 days.

Separately, CMS has yet to further regulate the private accrediting agencies that oversee the majority of U.S. hospitals, following an HHS inspector general report from June 2021 that found “CMS could not ensure that accredited hospitals would continue to provide quality care and operate safely during the COVID-19 emergency” and could not guarantee safety going forward. The report cited holes in CMS’ authority to make accrediting agencies execute a special, covid-spurred infection control survey for hospitals to ensure patient safety.

Seema Verma, who served as CMS administrator under President Donald Trump, said hospital-acquired infections are a long-standing issue that covid exacerbated — and one that most Americans are unaware of when they choose where to receive care.

She called for more transparency so patients can decide which hospitals are safe for them. She also called for changes in the accreditation system, which she said is fundamentally flawed because of conflicts of interests between the accrediting organizations’ consulting arms and the hospitals they inspect.

“The American public should have faith that the people that are doing the surveys don’t have a financial interest with the institution they are surveying,” Verma said.

Accrediting agencies have defended their practices during the pandemic, saying they worked with CMS as they could during the emergency.

In the U.S., about 90% of hospitals elect to pay private accrediting agencies, instead of government inspectors, to certify they are safe. But academics have shown that such agencies have not been associated with lower patient mortality, and CMS even has data showing how accrediting agencies fall short compared with government inspectors. A potential CMS rule dealing with conflict-of-interest concerns was slated to be posted in April but has yet to be made public.

Fleisher declined to say when to expect any such rule proposal but did say CMS agreed with last summer’s inspector general report on the failings in CMS authority. Fleisher said his agency would like to require accrediting organizations to perform special surveys of hospitals at CMS’ discretion.

“There will be an opportunity to comment on this issue,” he said. He added that the agency’s top priority is to ensure “patients have access to safe, equitable, quality health care.”

Patient advocates said the agency needs to do better — and the public needs to push it to do so.

“The people who were harmed during the pandemic deserve to be accounted for,” said McGiffert. “Frankly, I’ve been a little shocked at how accepting the American public is that hospitals cannot manage to do the things they must do to keep patients safe during a pandemic.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Updated July 8 at 9:11 AM.