The federal government is preparing to crack down aggressively on hospitals for not reporting complete COVID-19 data daily into a federal data system, according to internal documents obtained by NPR.
The draft guidance, expected to be sent to hospitals this week, also adds new reporting requirements, asking hospitals to provide daily information on influenza cases, along with COVID-19. It's the latest twist in what hospitals describe as a maddening flurry of changing requirements as they deal with the strain of caring for patients during a pandemic.
The reporting system drew national attention in July when the Department of Health and Human Services told hospitals to stop reporting information — such as the number of COVID-19 patients and the availability of intensive care beds — to the Centers for Disease Control and Prevention, and instead report it into a new system managed directly by HHS, the CDC's parent agency. The switch raised concerns from politicians and public health experts about the sidelining of the CDC, the nation's public health agency, in the midst of a pandemic.
Hospitals have been waiting for the details on how the federal government would enforce the new data reporting process. Last month, the Centers for Medicare & Medicaid Services (also part of HHS) abruptly issued a rule indicating that failure to comply could cause hospitals to lose their federal Medicare funding.
Now the agency appears to be preparing to follow through on that threat. A draft letter from the agency, obtained by NPR, requires hospitals to report data such as the number of COVID-19 patients and their inventory of the drug remdesivir "for all seven days, including weekends" into the federal data collection system run by HHS. Failure to comply after multiple warnings "will result in a termination of the Medicare provider agreement."
Threatening Medicare funding is "the nuclear option" for the federal health agency, says Dave Dillon of the Missouri Hospital Association. "If what [the Centers for Medicare & Medicaid Services is] proposing were to go into to effect and if, in fact, they were to do that kind of enforcement, that would shut down the health care system in the country."
"The idea of threatening to terminate a hospital from Medicare for not submitting this data every single day seems just very disproportionate," says Erin Fuse Brown, a health law professor at Georgia State University. "Terminating hospitals' Medicare participation is like a death sentence, financially, for a hospital."
The Centers for Medicare & Medicaid Services rule enforcement is a blunt tool that could be intended to fulfill HHS' determination to get each and every hospital to report. As part of the justification for the switch to the new system, then-HHS chief spokesperson Michael Caputo complained that the CDC's voluntary reporting system provided data from only 85% of hospitals. "[T]he President's COVID response requires 100 percent to report," he wrote in a statement to NPR in mid-July.
If the draft enforcement guidance went into effect today, around three-quarters of hospitals could be subject to receiving a warning. Just 24% of America's hospitals met the HHS reporting requirements for the week of Sept. 14, according to an internal CDC presentation given at a daily pandemic response meeting on Wednesday, obtained by NPR. No state was in full compliance.
The July change to data reporting created a large and costly administrative burden for hospitals without providing funding to help them fulfill it. The new draft guidance would further expand the scope.
The data hospitals were asked to provide as of July is complicated and time-consuming to gather, says Carrie Kroll of the Texas Hospital Association. "This required multiple people in different parts of the hospital — we were talking about bedside nursing-type statistics in terms of COVID patients versus adult versus child. Then you're talking about pharmaceuticals, so that's going to come from the pharmacy."
Hospitals have also been asked to provide information on supplies, such as how many single exam gloves they have in the building. According to the internal presentation, data on the supplies of ventilators, gloves and gowns, currently required to be reported three times a week, were frequently missing.
The pending update to the reporting guidelines will only require the supply data once a week. However, draft documents show the newest guidelines would add several questions about influenza patients such as the number admitted to the hospital with flu, the number of flu patients in intensive care unit beds and the number of patients confirmed to have both flu and COVID-19. This information may be required to be reported daily from late October, according to a draft document.
Carrie Williams, also of the Texas Hospital Association, was surprised that flu questions were potentially going to be added. "The constantly changing goal posts are going to be a real challenge for hospitals," she says. "We want to be in compliance, we want to make sure that we're providing the federal government with whatever they need for planning and resources. It's just — another change is a challenge in the middle of a pandemic."
Data scientists have raised concerns about the consequences of the new reporting requirements and the impending enforcement of them.
The added burden and stress could incentivize hospital staff to report inaccurate information, so as not to lose funding, says Lisa M. Lee, former chief science officer for public health surveillance at the CDC, who now works at Virginia Tech.
"I am afraid this will make the data much less accurate and reliable, and that is only going to hurt the American public," Lee says.