Employers — including companies, state governments and universities — purchase health care on behalf of roughly 150 million Americans. The cost of that care has continued to climb for both businesses and their workers.
For many years, employers saw wasteful care as the primary driver of their rising costs. They made benefits changes like adding wellness programs and raising deductibles to reduce unnecessary care, but costs continued to rise. Now, driven by a combination of new research and changing market forces — especially hospital consolidation — more employers see prices as their primary problem.
By amassing and analyzing employers’ claims data in innovative ways, academics and researchers at organizations like the Health Care Cost Institute (HCCI) and RAND have helped illuminate for employers two key truths about the hospital-based health care they purchase:
1) PRICES VARY WIDELY FOR THE SAME SERVICES
Data show that providers charge private payers very different prices for the exact same services — even within the same geographic area.
For example, HCCI found the price of a C-section delivery in the San Francisco Bay Area varies between hospitals by as much as:$24,107
Data show that hospitals charge employers and private insurers, on average, roughly twice what they charge Medicare for the exact same services. A recent RAND study analyzed more than 3,000 hospitals’ prices and found the most expensive facility in the country charged employers:4.1xMedicare
Hospitals claim this price difference is necessary because public payers like Medicare do not pay enough. However, there is a wide gap between the amount hospitals lose on Medicare (around -9% for inpatient care) and the amount more they charge employers compared to Medicare (200% or more).
A small but growing group of companies, public employers (like state governments and universities) and unions is using new data and tactics to tackle these high prices. (Learn more about who’s leading this work, how and why by listening to our full podcast episode in the player above.)
Note that the employers leading this charge tend to be large and self-funded, meaning they shoulder the risk for the insurance they provide employees, giving them extra flexibility and motivation to purchase health care differently. The approaches they are taking include:
Some employers are implementing so-called tiered networks, where employees pay more if they want to continue seeing certain, more expensive providers. Others are trying to strongly steer employees to particular hospitals, sometimes know as centers of excellence, where employers have made special deals for particular services.
Purdue University, for example, covers travel and lodging and offers a $500 stipend to employees that get hip or knee replacements done at one Indiana hospital.
Negotiating New Deals
There is a movement among some employers to renegotiate hospital deals using Medicare rates as the baseline — since they are transparent and account for hospitals’ unique attributes like location and patient mix — as opposed to negotiating down from charges set by hospitals, which are seen by many as opaque and arbitrary. Other employers are pressuring their insurance carriers to renegotiate the contracts they have with hospitals.
In 2016, the Montana state employee health plan, led by Marilyn Bartlett, got all of the state’s hospitals to agree to a payment rate based on a multiple of Medicare. They saved more than $30 million in just three years. Bartlett is now advising other states trying to follow her playbook.
In 2020, several large Indiana employers urged insurance carrier Anthem to renegotiate their contract with Parkview Health, a hospital system RAND researchers identified as one of the most expensive in the country. After months of tense back-and-forth, the pair reached a five-year deal expected to save Anthem customers $700 million.
Legislating, Regulating, Litigating
Some employer coalitions are advocating for more intervention by policymakers to cap health care prices or at least make them more transparent. States like Colorado and Indiana have passed price transparency legislation, and new federal rules now require more hospital price transparency on a national level. Advocates expect strong industry opposition to stiffer measures, like price caps, which recently failed in the Montana legislature.
Other advocates are calling for more scrutiny by state and federal officials of hospital mergers and other anticompetitive practices. Some employers and unions have even resorted to suing hospitals like Sutter Health in California.
Employers face a few key barriers to purchasing health care in different and more efficient ways:
Hospitals tend to have much more market power than individual employers, and that power has grown in recent years, enabling them to raise prices. Even very large employers have geographically dispersed workforces, making it hard to exert much leverage over any given hospital. Some employers have tried forming purchasing coalitions to pool their buying power, but they face tricky organizational dynamics and laws that prohibit collusion.
Employers can attempt to lower prices by renegotiating contracts with hospitals or tailoring provider networks, but the work is complicated and rife with tradeoffs. Few employers are sophisticated enough, for example, to assess a provider’s quality or to structure hospital payments in new ways.Employers looking for insurers to help them have limited options, as that industry has also become highly consolidated.
Employers say they primarily provide benefits to recruit and retain happy and healthy employees. Many are reluctant to risk upsetting employees by cutting out expensive providers or redesigning benefits in other ways. A recent KFF survey found just 4% of employers had dropped a hospital in order to cut costs.
Employers play a unique role in the United States health care system, and in the lives of the 150 million Americans who get insurance through work. For years, critics have questioned the wisdom of an employer-based health care system, and massive job losses created by the pandemic have reinforced those doubts for many.
Assuming employers do continue to purchase insurance on behalf of millions of Americans, though, focusing on lowering the prices they pay is one promising path to lowering total costs. However, as noted above, hospitals have expressed concern over the financial pressures they may face under these new deals. Complex benefit design strategies, like narrow or tiered networks, also run the risk of harming employees, who may make suboptimal choices or experience cost surprises. Finally, these strategies do not necessarily address other drivers of high costs including drug prices and wasteful care.
Fourteen of the nation’s largest health systems announced this week that they have joined together to form a new, for-profit data company aimed at aggregating and mining their clinical data. Called Truveta, the company will draw on the de-identified health records of millions of patients from thousands of care sites across 40 states, allowing researchers, physicians, biopharma companies, and others to draw insights aimed at “improving the lives of those they serve.”
Health system participants include the multi-state Catholic systems CommonSpirit Health, Trinity Health, Providence, and Bon Secours Mercy, the for-profit system Tenet Healthcare, and a number of regional systems. The new company will be led by former Microsoft executive Terry Myerson, who has been working on the project since March of last year. As large technology companies like Amazon and Google continue to build out healthcare offerings, and national insurers like UnitedHealth Group and Aetna continue to grow their analytical capabilities based on physician, hospital, and pharmacy encounters, it’s surprising that hospital systems are only now mobilizing in a concerted way to monetize the clinical data they generate.
Like Civica, an earlier health system collaboration around pharmaceutical manufacturing, Truveta’s launch signals that large national and regional systems are waking up to the value of scale they’ve amassed over time, moving beyond pricing leverage to capture other benefits from the size of their clinical operations—and exploring non-merger partnerships to create value from collaboration. There will inevitably be questions about how patient data is used by Truveta and its eventual customers, but we believe the venture holds real promise for harnessing the power of massive clinical datasets to drive improvement in how care is delivered.
Anti-inflammatory oral drug colchicine improved COVID-19 outcomes for patients with relatively mild cases, according to certain topline results from the COLCORONA trial announced in a brief press release.
Overall, the drug used for gout and rheumatic diseases reduced risk of death or hospitalizations by 21% versus placebo, which “approached statistical significance.”
However, there was a significant effect among the 4,159 of 4,488 patients who had their diagnosis of COVID-19 confirmed by a positive PCR test:
25% fewer hospitalizations
50% less need for mechanical ventilation
44% fewer deaths
If full data confirm the topline claims — the press release offered no other details, and did not mention plans for publication or conference presentation — colchicine would become the first oral drug proven to benefit non-hospitalized patients with COVID-19.
“Our research shows the efficacy of colchicine treatment in preventing the ‘cytokine storm’ phenomenon and reducing the complications associated with COVID-19,” principal investigator Jean-Claude Tardif, MD, of the Montreal Heart Institute, said in the press release. He predicted its use “could have a significant impact on public health and potentially prevent COVID-19 complications for millions of patients.”
Currently, the “tiny list of outpatient therapies that work” for COVID-19 includes convalescent plasma and monoclonal antibodies, which “are logistically challenging (require infusions, must be started very early after symptom onset),” tweeted Ilan Schwartz, MD, PhD, an infectious diseases researcher at the University of Alberta in Edmonton.
The COLCORONA findings were “very encouraging,” tweeted Martin Landray, MB ChB, PhD, of the Big Data Institute at the University of Oxford in England. His group’s RECOVERY trial has already randomized more than 6,500 hospitalized patients to colchicine versus usual care as one of the arms of the platform trial, though he did not offer any findings from that study.
“Different stage of disease so remains an important question,” he tweeted. “Maybe old drugs can learn new tricks!” Landray added, pointing to dexamethasone.
“I think this is an exciting time. Many groups have been pursuing lots of different questions related to COVID and its complications,” commented Richard Kovacs, MD, immediate past-president of the American College of Cardiology. “We’re now beginning to see the fruit of those studies.”
COLCORONA was conducted remotely, without in-person contact, with participants across Canada, the U.S., Europe, South America, and South Africa. It randomized participants double-blind to colchicine 0.5 mg or a matching placebo twice daily for the first 3 days and then once daily for the last 27 days.
Participants were ages 40 and older, not hospitalized at the time of enrollment, and had at least one risk factor for COVID-19 complications: age 70-plus, obesity, diabetes, uncontrolled hypertension, known asthma or chronic obstructive pulmonary disease, known heart failure, known coronary disease, fever of ≥38.4°C (101.12°F) within the last 48 hours, dyspnea at presentation, or certain blood cell abnormalities.
It had been planned as a 6,000-patient trial, but whether it was stopped for efficacy at a preplanned interim analysis or for some other reason was not spelled out in the press release. Whether the PCR-positive subgroup was preplanned also wasn’t clear. Key details such as confidence intervals, adverse effects, and subgroup results were omitted as well.
While a full manuscript is reportedly underway, “we don’t know enough to bring this into practice yet,” argued Kovacs.
Some physicians also warned about the potential for misuse of the findings and attendant risks.
Dhruv Nayyar, MD, of the University of Toronto, tweeted that he has already had “patients inquiring why we are not starting colchicine for them. Science by press release puts us in a difficult position while providing care. I just want to see the data.”
Angela Rasmussen, MD, a virologist with the Georgetown Center for Global Health Science and Security’s Viral Emergence Research Initiative in Washington, agreed, tweeting:“When HCQ [hydroxychloroquine] was promoted without solid data, there was at least one death from an overdose. We don’t need people self-medicating with colchicine.”
As was the case with hydroxychloroquine before the papers proved little efficacy in COVID-19, Kovacs told MedPage Today: “We always get concerned when these drugs are repurposed that we might see an unintended run on the drug and lessen the supply.”
Citing the well-known diarrheal side effect of colchicine, infectious diseases specialist Edsel Salvana, MD, of the University of Pittsburgh and University of the Philippines in Manila, tweeted a plea for use only in the trial-proven patient population with confirmed COVID-19 — not prophylaxis.
The dose used was on par with that used in cardiovascular prevention and other indications, so the diarrhea incidence would probably follow the roughly 10% rate seen in the COLCOT trial, Kovacs suggested.
In the clinic, too, there are some cautions. As Elin Roddy, MD, a respiratory physician at Shrewsbury and Telford Hospital NHS Trust in England, tweeted: “Lots of drug interactions with colchicine potentially — statins, macrolides, diltiazem — we have literally been running up to the ward to cross off clarithromycin if RECOVERY randomises to colchicine.”
Since the beginning of the coronavirus pandemic, Florida has blocked, obscured, delayed, and at times hidden the COVID-19 data used in making big decisions such as reopening schools and businesses.
And with scientists warning Thanksgiving gatherings could cause an explosion of infections, the shortcomings in the state’s viral reporting have yet to be fixed.
While the state has put out an enormous amount of information, some of its actions have raised concerns among researchers that state officials are being less than transparent.
It started even before the pandemic became a daily concern for millions of residents. Nearly 175 patients tested positive for the disease in January and February, evidence the Florida Department of Health collected but never acknowledged or explained. The state fired its nationally praised chief data manager, she says in a whistleblower lawsuit, after she refused to manipulate data to support premature reopening. The state said she was fired for not following orders.
The health department used to publish coronavirus statistics twice a day before changing to once a day, consistently meeting an 11 a.m. daily deadline for releasing new information that scientists, the media and the public could use to follow the pandemic’s latest twists.
But in the past month the department has routinely and inexplicably failed to meet its own deadline by as much as six hours. On one day in October, it published no update at all.
News outlets were forced to sue the state before it would publish information identifying the number of infections and deaths at individual nursing homes.
Throughout it all, the state has kept up with the rapidly spreading virus by publishing daily updates of the numbers of cases, deaths and hospitalizations.
“Florida makes a lot of data available that is a lot of use in tracking the pandemic,” University of South Florida epidemiologist Jason Salemi said. “They’re one of the only states, if not the only state, that releases daily case line data (showing age, sex and county for each infected person).”
Dr. Terry Adirim, chairwoman of Florida Atlantic University’s Department of Integrated Biomedical Science, agreed, to a point.
“The good side is they do have daily spreadsheets,” Adirim said. “However, it’s the data that they want to put out.”
The state leaves out crucial information that could help the public better understand who the virus is hurting and where it is spreading, Adirim said.
The department, under state Surgeon General Dr. Scott Rivkees, oversees 53? health agencies covering Florida’s 67 counties, such as the one in Palm Beach County headed by Dr. Alina Alonso.
Rivkees was appointed in April 2019. He reports to Gov. Ron DeSantis, a Republican who has supported President Donald Trump’s approach to fighting the coronavirus and pressured local officials to reopen schools and businesses despite a series of spikes indicating rapid spread of the disease.
At several points, the DeSantis administration muzzled local health directors, such as when it told them not to advise school boards on reopening campuses.
DOH Knew Virus Here Since January
The health department’s own coronavirus reports indicated that the pathogen had been infecting Floridians since January, yet health officials never informed the public about it and they did not publicly acknowledge it even after The Palm Beach Post first reported it in May.
In fact, the night before The Post broke the story, the department inexplicably removed from public view the state’s dataset that provided the evidence. Mixed among listings of thousands of cases was evidence that up to 171 people ages 4 to 91 had tested positive for COVID-19 in the months before officials announced in March the disease’s presence in the state.
Were the media reports on the meaning of those 171 cases in error? The state has never said.
No Testing Stats Initially
When positive tests were finally acknowledged in March, all tests had to be confirmed by federal health officials. But Florida health officials refused to even acknowledge how many people in each county had been tested.
State health officials and DeSantis claimed they had to withhold the information to protect patient privacy, but they provided no evidence that stating the number of people tested would reveal personal information.
At the same time, the director of the Hillsborough County branch of the state health department publicly revealed that information to Hillsborough County commissioners.
And during March the state published on a website that wasn’t promoted to the public the ages and genders of those who had been confirmed to be carrying the disease, along with the counties where they claimed residence.
Firing Coronavirus Data Chief
In May, with the media asking about data that revealed the earlier onset of the disease, internal emails show that a department manager ordered the state’s coronavirus data chief to yank the information off the web, even though it had been online for months.
A health department tech supervisor told data manager Rebekah Jones on May 5 to take down the dataset. Jones replied in an email that was the “wrong call,” but complied, only to be ordered an hour later to put it back.
That day, she emailed reporters and researchers following a listserv she created, saying she had been removed from handling coronavirus data because she refused to manipulate datasets to justify DeSantis’ push to begin reopening businesses and public places.
Two weeks later, the health department fired Jones, who in March had created and maintained Florida’s one-stop coronavirus dashboard, which had been viewed by millions of people, and had been praised nationally, including by White House Coronavirus Task Force Coordinator Deborah Birx.
The dashboard allows viewers to explore the total number of coronavirus cases, deaths, tests and other information statewide and by county and across age groups and genders.
DeSantis claimed on May 21 that Jones wanted to upload bad coronavirus data to the state’s website. To further attempt to discredit her, he brought up stalking charges made against her by an ex-lover, stemming from a blog post she wrote, that led to two misdemeanor charges.
Using her technical know-how, Jones launched a competing COVID-19 dashboard website, FloridaCOVIDAction.com in early June. After national media covered Jones’ firing and website launch, people donated more than $200,000 to her through GoFundMe to help pay her bills and maintain the website.
People view her site more than 1 million times a day, she said. The website features the same type of data the state’s dashboard displays, but also includes information not present on the state’s site such as a listing of testing sites and their contact information.
Jones also helped launch TheCOVIDMonitor.com to collect reports of infections in schools across the country.
Jones filed a whistleblower complaint against the state in July, accusing managers of retaliating against her for refusing to change the data to make the coronavirus situation look better.
“The Florida Department of Health needs a data auditor not affiliated with the governor’s office because they cannot be trusted,” Jones said Friday.
Florida Hides Death Details
When coronavirus kills someone, their county’s medical examiner’s office logs their name, age, ethnicity and other information, and sends it to the Florida Department of Law Enforcement.
During March and April, the department refused requests to release that information to the public, even though medical examiners in Florida always have made it public under state law. Many county medical examiners, acknowledging the role that public information can play in combating a pandemic, released the information without dispute.
But it took legal pressure from news outlets, including The Post, before FDLE agreed to release the records it collected from local medical examiners.
When FDLE finally published the document on May 6, it blacked out or excluded crucial information such as each victim’s name or cause of death.
But FDLE’s attempt to obscure some of that information failed when, upon closer examination, the seemingly redacted details could in fact be read by common computer software.
Outlets such as Gannett, which owns The Post, and The New York Times, extracted the data invisible to the naked eye and reported in detail what the state redacted, such as the details on how each patient died.
Reluctantly Revealing Elder Care Deaths, Hospitalizations
It took a lawsuit against the state filed by the Miami Herald, joined by The Post and other news outlets, before the health department began publishing the names of long-term care facilities with the numbers of coronavirus cases and deaths.
The publication provided the only official source for family members to find out how many people had died of COVID-19 at the long-term care facility housing their loved ones.
While the state agreed to publish the information weekly, it has failed to publish several times and as of Nov. 24 had not updated the information since Nov. 6.
It took more pressure from Florida news outlets to pry from the state government the number of beds in each hospital being occupied by coronavirus patients, a key indicator of the disease’s spread, DeSantis said.
That was one issue where USF’s Salemi publicly criticized Florida.
“They were one of the last three states to release that information,” he said. “That to me is a problem because it is a key indicator.”
Confusion Over Positivity Rate
One metric DeSantis touted to justify his decision in May to begin reopening Florida’s economy was the so-called positivity rate, which is the share of tests reported each day with positive results.
But Florida’s daily figures contrasted sharply with calculations made by Johns Hopkins University, prompting a South Florida Sun-Sentinel examination that showed Florida’s methodology underestimated the positivity rate.
The state counts people who have tested positive only once, but counts every negative test a person receives until they test positive, so that there are many more negative tests for every positive one.
John Hopkins University, on the other hand, calculated Florida’s positivity rate by comparing the number of people testing positive with the total number of people who got tested for the first time.
By John Hopkins’ measure, between 10 and 11 percent of Florida’s tests in October came up positive, compared to the state’s reported rate of between 4 and 5 percent.
Health experts such as those at the World Health Organization have said a state’s positivity rate should stay below 5 percent for 14 days straight before it considers the virus under control and go forward with reopening public places and businesses. It’s also an important measure for travelers, who may be required to quarantine if they enter a state with a high positivity rate.
Withholding Detail on Race, Ethnicity
The Post reported in June that the share of tests taken by Black and Hispanic people and in majority minority ZIP codes were twice as likely to come back positive compared to tests conducted on white people and in majority white ZIP codes.
That was based on a Post analysis of internal state data the health department will not share with the public.
The state publishes bar charts showing general racial breakdowns but not for each infected person.
If it wanted to, Florida’s health department could publish detailed data that would shed light on the infection rates among each race and ethnicity or each age group, as well as which neighborhoods are seeing high rates of contagion.
Researchers have been trying to obtain this data but “the state won’t release the data without (making us) undergo an arduous data use agreement application process with no guarantee of release of the data,” Adirim said. Researchers must read and sign a 26-page, nearly 5,700-word agreement before getting a chance at seeing the raw data.
While Florida publishes the ages, genders and counties of residence for each infected person, “there’s no identification for race or ethnicity, no ZIP code or city of the residence of the patient,” Adirim said. “No line item count of negative test data so it’s hard to do your own calculation of test positivity.”
While Florida doesn’t explain its reasoning, one fear of releasing such information is the risk of identifying patients, particularly in tiny, non-diverse counties.
Confusion Over Lab Results
Florida’s daily report shows how many positive results come from each laboratory statewide. Except when it doesn’t.
The report has shown for months that 100 percent of COVID-19 tests conducted by some labs have come back positive despite those labs saying that shouldn’t be the case.
While the department reported in July that all 410 results from a Lee County lab were positive, a lab spokesman told The Post the lab had conducted roughly 30,000 tests. Other labs expressed the same confusion when informed of the state’s reporting.
The state health department said it would work with labs to fix the error. But even as recently as Tuesday, the state’s daily report showed positive result rates of 100 percent or just under it from some labs, comprising hundreds of tests.
Mistakenly Revealing School Infections
As DeSantis pushed in August for reopening schools and universities for students to attend in-person classes, Florida’s health department published a report showing hundreds of infections could be traced back to schools, before pulling that report from public view.
The health department claimed it published that data by mistake, the Miami Herald reported.
The report showed that COVID-19 had infected nearly 900 students and staffers.
The state resumed school infection reporting in September.
A similar publication of cases at day-care centers appeared online briefly in August only to come down permanently.
After shifting in late April to updating the public just once a day at 11 a.m. instead of twice daily, the state met that deadline on most days until it started to falter in October. Pandemic followers could rely on the predictability.
On Oct. 10, the state published no data at all, not informing the public of a problem until 5 p.m.
The state blamed a private lab for the failure but the next day retracted its statement after the private lab disputed the state’s explanation. No further explanation has been offered.
On Oct. 21, the report came out six hours late.
Since Nov. 3, the 11 a.m. deadline has never been met. Now, late afternoon releases have become the norm.
“They have gotten more sloppy and they have really dragged their feet,” Adirim, the FAU scientist, said.
No spokesperson for the health department has answered questions from The Post to explain the lengthy delays. Alberto Moscoso, the spokesman throughout the pandemic, departed without explanation Nov. 6.
The state’s tardiness can trip up researchers trying to track the pandemic in Florida, Adirim said, because if one misses a late-day update, the department could overwrite it with another update the next morning, eliminating critical information and damaging scientists’ analysis.
Hired Sports Blogger to Analyze Data
As if to show disregard for concerns raised by scientists, the DeSantis administration brought in a new data analyst who bragged online that he is no expert and doesn’t need to be.
Kyle Lamb, an Uber driver and sports blogger, sees his lack of experience as a plus.
“Fact is, I’m not an ‘expert’,” Lamb wrote on a website for a subscribers-only podcast he hosts about the coronavirus. “I also don’t need to be. Experts don’t have all the answers, and we’ve learned that the hard way throughout the entire duration of the global pandemic.”
Much of his coronavirus writings can be found on Twitter, where he has said masks and mandatory quarantines don’t stop the virus’ spread, and that hydroxychloroquine, a drug touted by President Donald Trump but rejected by medical researchers, treats it successfully.
While DeSantis says lockdowns aren’t effective in stopping the spread and refuses to enact a statewide mask mandate, scientists point out that quarantines and masks are extremely effective.
The U.S. Food and Drug Administration has said hydroxychloroquine is unlikely to help and poses greater risk to patients than any potential benefits.
Coronavirus researchers have called Lamb’s views “laughable,” and fellow sports bloggers have said he tends to act like he knows much about a subject in which he knows little, the Miami Herald reported.
DeSantis has yet to explain how and why Lamb was hired, nor has his office released Lamb’s application for the $40,000-a-year job. “We generally do not comment on such entry level hirings,” DeSantis spokesman Fred Piccolo said Tuesday by email.
It could be worse.
Texas health department workers have to manually enter data they read from paper faxes into the state’s coronavirus tracking system, The Texas Tribune has reported. And unlike Florida, Texas doesn’t require local health officials to report viral data to the state in a uniform way that would make it easier and faster to process and report.
It could be better.
In Wisconsin, health officials report the number of cases and deaths down to the neighborhood level. They also plainly report racial and ethnic disparities, which show the disease hits Hispanic residents hardest.
Still, Salemi worries that Florida’s lack of answers can undermine residents’ faith.
“My whole thing is the communication, the transparency,” Salemi said. “Just let us know what’s going on. That can stop people from assuming the worst. Even if you make a big error people are a lot more forgiving, whereas if the only time you’re communicating is when bad things happen … people start to wonder.”
A group of health system leaders in Missouri challenged state-reported hospital bed data, saying it could lead to a misunderstanding about hospital capacity, according to a Nov. 19 report in the St. Louis Business Journal.
A consortium of health systems, including St. Louis-based BJC HealthCare, Mercy, SSM Health and St. Luke’s Hospital, released urgent reports warning that hospital and ICU beds are nearing capacity while state data reports show a much different story.
The state reports, based on data from TeleTracking and the CDC-managed National Healthcare Safety Network, show inpatient hospital bed capacity at 35 percent and remaining ICU bed capacity at 29 percent on Nov. 19. However, the consortium reported hospitals are fuller, at 84 percent capacity as of Nov. 18, and ICUs at 90 percent capacity based on staffed bed availability. The consortium says it is using staffed bed data while the state’s numbers are based on licensed bed counts; the state contends it does take staffing into account, according to the report.
Stephanie Zoller Mueller, a spokesperson for the consortium, said the discrepancy between the state’s data and consortium’s data could create a “gross misunderstanding on the part of some and can be a dangerous message to the community.”
Crafting successful public health measures depends on the ability of top scientists to gather data and report their findings unrestricted to policymakers.
State of play: But concern has spiked among health experts and physicians over what they see as an assault on key science protections, particularly during a raging pandemic. And a move last week by President Trump, via an executive order, is triggering even more worries.
What’s happening: If implemented, the order creates a “Schedule F” class of federal employees who are policymakers from certain agencies who would no longer have protection against being easily fired— and would likely include some veteran civil service scientists who offer key guidance to Congress and the White House.
“If you take how it’s written at face value, it has the potential to turn every government employee into a political appointee, who can be hired and fired at the whim of a political appointee or even the president,” says University of Colorado Boulder’s Roger Pielke Jr.
Protections for members of civil service allow them to argue for evidence-based decision-making and enable them to provide the best advice, says CRDF Global’s Julie Fischer, adding that “federal decision-makers really need access to that expertise — quickly and ideally in house.”
Between the lines: Politics plays some role in science, via funding, policymaking and national security issues.
The public health system is a mix of agency leaders who are political appointees, like HHS Secretary Alex Azar, and career civil servants not dependent on the president’s approval, like NIAID director Anthony Fauci.
“Public health is inherently political because it has to do with controlling the way human beings move around,” says University of Pennsylvania’s Jonathan Moreno.
Yes, but: The norm is to have a robust discussion — and what has been happening under the Trump administration is not the norm, some say.
“Schedule F is just remarkable,” Pielke says. “It’s not like political appointees editing a report, [who are] working within the system to kind of subvert the system. This is an effort to completely redefine the system.”
The Center for Strategic and International Studies’ Stephen Morrison says that the administration has been defying normative practices, including statements denigrating scientists, the CDC and FDA.
The big picture: Public trust in scientists,which tends to be high, is taking a hit, not only due to messaging from the administration but also from public confusion over changes in guidance, which vacillated over masks and other suggestions.
Public health institutions “need to have the trust of the American people. In order to have the trust of the American people, they can’t have their autonomy and their credibility compromised, and they have to have a voice,” Morrison says.
“If you deny CDC the ability to have briefings for the public, and you take away control over authoring their guidance, and you attack them and discredit them so public perceptions of them are negative, you are taking them out of the game and leaving the stage completely open for falsehoods,” he adds.
“All scientists don’t agree on all the evidence, every time. But what we do agree on is that there’s a process. We look at what we know, we decide what we can clearly recommend based on what we know, sometimes when we learn more, we change our recommendations, and that’s the scientific process,” Fischer says.
What’s next: The scientific community is going to need to be proactive on rebuilding public trust in how the scientific process works and being clear when guidance changes and why it has changed, Fischer says.
A patchwork approach to contact tracing across state health departments is making it increasingly difficult to know where people are getting exposed to COVID-19.
While some states like Louisiana and Washington state publicly track detailed data related to COVID-19 cases in bars, camps, daycares, churches, worksites and restaurants, most states do not, creating obstacles to preventing future cases.
The extensive spread of the virus, combined with the country’s 50-state approach to pandemic response, has led to a dearth of information about where transmissions are occurring. Those shortcomings are in turn complicating efforts to safely open the economy and to understand the risks associated with certain activities and settings.
Experts know COVID-19 spreads in crowded indoor spaces, but more specifics could help state and local lawmakers strike a better balance between public health needs and those of the economy.
“If you want to take a more targeted approach to public health measures, the more information you have the better,” said Joshua Michaud, an associate director for global health policy at the Kaiser Family Foundation and an infectious disease epidemiologist.
“Rather than have a blunt, close-everything-down approach, you could be a bit more targeted and surgical about how you implement certain measures,” he added.
The Hill asked every state for information about the data they collect and share as part of their contact tracing programs, one of the main tools public health officials have to slow the spread of COVID-19.
Most states release information about outbreaks and cases at congregate settings like nursing homes, meatpacking plants, and prisons, which comprise the majority of cases. But there is less information publicly available about the numbers of cases or outbreaks tied to other settings commonly visited by people.
For example, Louisiana has tied 468 cases to bars in the state, but most of the new cases in the past week have been tied to food processing plants.
In The Hill’s review of publicly available state data, other settings for COVID-19 transmission include restaurants, childcare centers, gyms, colleges and schools, churches, retailers, weddings and other private social events. It is not clear how widely those settings contributed to infections because widespread transmission of the virus means many people who get sick do not get interviewed by contact tracers — over the past week, there has been an average of 42,000 confirmed cases, though many more are likely going undetected.
State health departments in Idaho, Illinois, Massachusetts, Mississippi, Missouri, New Hampshire, North Carolina, South Carolina, Tennessee, Texas, Vermont, Virginia and West Virginia told The Hill they don’t track location data.
Utah tracks outbreaks and cases tied to workplaces and schools, but not restaurants or bars.
Arizona, California, Delaware, Indiana, Oregon and Pennsylvania track infection locations, but don’t release it to the public.
“The number of people getting COVID-19 from isolated, identifiable outbreaks, such as those in long term care facilities, is decreasing, and more people are contracting COVID-19 from being out and about in their community, such as when visiting restaurants and bars,” said Maggi Mumma, a spokeswoman for the Pennsylvania Department of Health.
Bars, indoor dining and gyms are still closed in most of New York and New Jersey, so there is no current data to track for those settings.
But the state health departments also don’t release data on outbreaks or cases tied to other settings like childcare or retail stores.
For example, Minnesota lists nearly 7,000 cases as being tied to “community” exposure, but that includes settings like restaurants, bars and workspaces.
In Iowa, a state health department spokesperson said the agency is working on extracting and sharing this type of data on its website, while Maine would not say if they track by specific location.
The remaining state health departments did not respond to multiple requests for comment from The Hill and don’t have information about outbreaks or exposure settings on their websites.
Several states said local health departments may be tracking infection locations even if the state is not.
Experts said such a decentralized approach can miss outbreaks if local departments aren’t communicating with each other, meaning any data should be public.
“I do think it would be very valuable for states to make that information public,” said Crystal Watson, assistant professor at Johns Hopkins Bloomberg School of Public Health.
“It helps us collectively get a better understanding as policymakers, as people trying to help in the response. It can also help with personal decision making for people to understand … where it’s most dangerous to go related to getting infected,” Watson said.
The disparities between state health departments are partially due to a lack of federal guidance.
There are no federal requirements on the information contact tracers collect; guidelines vary from state to state, and sometimes from county to county.
Tracking data about where people are getting sick would allow states to take a “cluster busting” approach, experts said, by working backwards from confirmed cases to find where patients might have first contracted the disease, potentially stopping future outbreaks.
That approach requires a change in mindset for contact tracers, who typically focus on reaching close contacts of confirmed cases who might have been exposed to the virus. But research shows between 10 and 20 percent of people are responsible for about 80 percent of new infections, mostly through so-called super-spreader events.
“We know that the way this virus has transmitted is highly clustered groups and anytime you have settings where a lot of people are together in one place,” said Kaiser’s Michaud.
“Collecting good information on this — the cluster busting approach — is a good way to find out where your prevention efforts can have the best bang for your buck,” he said.
At the same time, some state programs are still not operating at full force and are struggling to keep up with widespread infections.
“I think that many parts of the country, especially outside of the Northeast … simply have too many cases to use contact tracing as the primary public health measure to control cases,” said Stephen Kissler, a research fellow at the Harvard T.H. School of Public Health.
“It’s just not enough,” he said. “We just don’t have enough resources, and in a lot of these places enough contact tracers, to follow up on all of the cases.”
Problems with the government’s rationale for authorizing use of convalescent plasma in COVID-19 patients go far beyond the dustup over the purported 35% survival benefit cited by top officials on Sunday, numerous researchers say.
Much of it came from the Mayo Clinic and FDA expanded access program (EAP), at this point published only as a preprint manuscript. Although a large number of patients were included, the study was observational only, with no untreated control group. That makes the findings merely hypothesis-generating, and can’t offer any firm conclusions.
That’s fine for issuing an emergency use authorization (EUA), but not so much for making claims about survival benefit, independent researchers said.
“It’s not even a question of overstating,” Adam Gaffney, MD, MPH, a critical care doctor and health policy researcher at Harvard Medical School, told MedPage Today. “You can’t state much at all when you don’t have a randomized controlled trial.”
“People have made a big deal of Hahn referring to relative versus absolute risk reduction, but I think that’s less of a big deal,” Gaffney said. “The biggest problem is that the data they are citing … is not randomized. That’s the source of all the problems.”
Hahn took heat for saying that a “35% improvement in survival is a pretty substantial clinical benefit” further explaining that of “100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”
Critics rapidly took to Twitter, stating that the interpretation was incorrect. Hahn was referring to relative risk reduction, not absolute risk reduction. Thus, calculating the number of lives saved — which isn’t something experts recommend doing based on observational data in the first place — would have translated to somewhere more in the ballpark of 5 out of 100.
Moreover, the “risk reduction” came from a comparison of patients treated with high-titer plasma versus those receiving lower-titer preparations. The study offered no basis for concluding how many patients may have been “saved” relative to standard care.
And the 35% reduction in that analysis was for 7-day mortality; the relative reduction at 30 days was only 23%.
Hahn’s recital of the 35% figure “was just PART of the error,” tweeted Vinay Prasad, MD, MPH, of the University of California San Francisco. “The entire comparison is flawed. It is not a suitable control. The data don’t show anything useful.”
“The much broader problem here is the lack of commitment to performing large, national randomized controlled trials,” Gaffney said. “We could have done it for convalescent plasma. Instead, we did the EAP. I understand why people wanted it, but now we don’t know [if convalescent plasma works]. We have a question mark instead of a period.”
Undermining Trust in FDA?
Critics have charged that serious mistakes like Hahn’s misstatement could undermine FDA’s credibility, especially as it faces challenging decisions about potentially approving a vaccine this fall.
“This is playing out in the context of a hyper-politicized moment,” Gaffney said. “It behooves everyone to be extremely cautious in speaking about these things to avoid the appearance of politicization.”
On CBS This Morning on Tuesday, Hahn addressed concerns about politicization by offering reassurance to the “American people that this decision was made based upon sound science and data.”
In response to questions about the timing of the EUA announcement — it came just a day after President Donald Trump tweeted allegations that the “deep state” was holding back access to COVID-19 treatments with Hahn’s Twitter handle cited, and a day before the Republican National Convention got underway — Hahn said the agency had been working on the application for 3 or 4 weeks and was waiting on additional validation data, which were received at the end of last week and over the weekend.
“We’re going to continue to get data and as we’ve done with any other authorization, we will update that decision as new data come,” Hahn said on the news program. His agency initially issued an EUA for hydroxychloroquine, for instance, but later revoked it when the negative randomized trial data became available.
Lack of Access to FDA’s Data Review
Whether the public will ever see the full convalescent plasma data underlying the EUA is another matter. The “Clinical Memorandum” issued as the evidence behind the FDA’s decision glossed over the statistical analysis conducted by the agency; in particular, it made no mention of the 35% relative reduction in deaths.
Another problem with that is the 35% figure’s source isn’t fully clear. Although the EAP preprint manuscript is the most obvious source, Gaffney noted that HHS Secretary Alex Azar said it referred to a subgroup of patients under age 80 who were not on a ventilator. That is not found in the publicly available data. He also pointed to a tweet by FDA spokesperson Emily Miller that contains an agency slide showing a 37% reduction in mortality for non-intubated patients age 80 or under treated within 72 hours who got high-titer convalescent plasma, compared with low-titer product. Neither of those figures is reflected in the EAP manuscript.
The FDA did not return a request by MedPage Today for the full summary of data reviewed by FDA and any independent statistical analysis done by the agency.
Shmuel Shoham, MD, of Johns Hopkins University in Baltimore, said during a press briefing organized by the Infectious Diseases Society of America that “enormous amounts of data have been generated” from the EAP, in which more than 70,000 patients have been treated.
“Some data have been reported in articles and at meetings, but that’s only part of what the FDA — this is their program — has access to,” he said. “The stuff in the public domain is only a fraction of the data they have collected.”
Shoham is on the scientific advisory board of the EAP and is involved in two convalescent plasma clinical trials at Johns Hopkins.
Gaffney said Mayo researchers and FDA reviewers have noted that physicians were blinded to the dose of antibody given in plasma infusions, which he described as a “pseudo-randomization effect. We could use that to make more causal inferences about the effectiveness of antibody titers.”
However, he said there were some significant differences between those who received high-titer versus low-titer antibody, including differences in P-to-F ratio (a measure of inhaled oxygen to blood oxygen) and in those with five or more severe risk factors, suggesting the low-titer group was sicker to begin with than the high-titer group.
Also, patients in the EAP received a variety of other treatments: about half got steroids and 40% were given remdesivir.
“This is why we do randomized controlled trials,” Gaffney said. “Without them it’s very difficult to ensure that the effect you see is the result of the drug, and not the result of patient characteristics.”
Is an Answer Forthcoming?
Several randomized controlled trials of convalescent plasma are underway in the U.S., but the big concern is that wider access to convalescent plasma will limit enrollment. Will clinicians recommend that their patients enroll in a trial in which they might receive placebo? Will patients agree?
For the Hopkins studies, the prevention trial has enrolled 25 people out of a goal of 500, and its outpatient trial has enrolled 50 people of its 600-patient goal.
Liise-anne Pirofski, MD, of Montefiore Medical Center in New York, started a study at the end of April, looking to enroll 300 people. She said the team enrolled the first 150 people quickly, but “then the pandemic began to wane in New York.” With subsequent funding from the NIH, the trial has managed to enroll 190 patients, and has now expanded to four additional sites: New York University, Yale, the University of Miami, and the University of Texas Houston.
Clifton Callaway, MD, PhD, of the University of Pittsburgh Medical Center and lead investigator on the C3PO trial looking at outpatient convalescent plasma, said he hopes the EUA doesn’t discourage participation.
“To the contrary, I believe it should reassure persons considering participation that the FDA feels that convalescent plasma is safe and potentially useful and that the FDA specifically comments: ‘Current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease.’ Giving high-titer convalescent plasma earlier (before you are sick enough to be in the hospital) is exactly what C3PO is testing.”
In addition to determining whether earlier or prophylactic treatment works, Shoham said other unanswered questions include identifying whether other components in plasma are useful therapies and whether low-titer plasma can work at all.
“What everyone agrees on is that the gaps in knowledge that exist can best be addressed by high-quality randomized controlled trials,” he said.
Pirofski said the science and data should be the focus, “rather than the decision and what drove the decision…. I don’t think anyone knows what drove that decision other than the people in that room. Hopefully they know.”
The order to reroute CDC hospitalization figures raised accuracy concerns. But that’s just one of the problems with how the country collects health data.
TWO WEEKS AGO, the Department of Health and Human Services stripped the Centers for Disease Control and Prevention of control of national data on Covid-19 infections in hospitalized patients. Instead of sending the data to the CDC’s public National Healthcare Safety Network (NHSN), the department ordered hospitals to send it to a new data system, run for the agency by a little-known firm in Tennessee.
The change took effect immediately. First, the hospitalization data collected up until July 13 vanished from the CDC’s site. One day later, it was republished—but topped by a note that the NHSN Covid-19 dashboard would no longer be updated.
Fury over the move was immediate. All the major organizations that represent US public health professionals objected vociferously. A quickly written protest letter addressed to Vice President Mike Pence, HHS secretary Alex Azar, and Deborah Birx, the coordinator of the White House’s Coronavirus Task Force, garnered signatures from more than 100 health associations and research groups. The reactions made visible the groups’ concerns that data could be lost or duplicated, and underlined their continual worry that the CDC is being undercut and sidelined. But it had no other effect. The new HHS portal, called HHS Protect, is up and running.
Behind the crisis lies a difficult reality: Covid-19 data in the US—in fact, almost all public health data—is chaotic: not one pipe, but a tangle. If the nation had a single, seamless system for collecting, storing, and analyzing health data, HHS and the Coronavirus Task Force would have had a much harder time prying the CDC’s Covid-19 data loose. Not having a comprehensive system made the HHS move possible, and however well or badly the department handles the data it will now receive, the lack of a comprehensive data system is harming the US coronavirus response.
“Every health system, every public health department, every jurisdiction really has their own ways of going about things,” says Caitlin Rivers, a senior scholar at the Johns Hopkins Center for Health Security. “It’s very difficult to get an accurate and timely and geographically resolved picture of what’s happening in the US, because there’s such a jumble of data.”
Data systems are wonky objects, so it may help to step back and explain a little history. First, there’s a reason why hospitalization data is important: Knowing whether the demand for beds is rising or falling can help illuminate how hard-hit any area is, and whether reopening in that region is safe.
Second, what the NHSN does is important too. It’s a 15-year-old database, organized in 2005 out of several streams of information that were already flowing to the CDC, which receives data from hospitals and other health care facilities about anything that affects the occurrence of infections once someone is admitted. That includes rates of pneumonia from use of ventilators, infections after surgery, and urinary tract infections from catheters, for instance—but also statistics about usage of antibiotics, adherence to hand hygiene, complications from dialysis, occurrence of the ravaging intestinal infection C. difficile, and rates of health care workers getting flu shots. Broadly, it assembles a portrait of the safety of hospitals, nursing homes, and chronic care institutions in the US, and it shares that data with researchers and with other statistical dashboards published by other HHS agencies such as the Center for Medicare and Medicaid Services.
Because NHSN only collects institutional data, and Covid-19 infections occur both inside institutions such as nursing homes and hospitals, and in the outside world, HHS officials claimed the database was a bad fit for the coronavirus pandemic. But people who have worked with it argue that since the network had already devised channels for receiving all that data from health care systems, it ought to continue to do so—especially since that data isn’t easy to abstract.
“If you are lucky enough to work in a large health care system that has a sophisticated electronic medical record, then possibly you can push one button and have all the data flow up to NHSN,” says Angela Vassallo, an epidemiologist who formerly worked at HHS and is now chief clinical adviser to the infection-prevention firm Covid Smart. “But that’s a rare experience. Most hospitals have an infection preventionist, usually an entire team, responsible for transferring that data by hand.”
There lies the core problem. Despite big efforts back during the Obama administration to funnel all US health care data into one large-bore pipeline, what exists now resembles what you’d find behind the walls of an old house: pipes going everywhere, patched at improbable angles, some of them leaky, and some of them dead ends. To take some examples from the coronavirus response: Covid-19 hospital admissions were measured by the NHSN (before HHS intervened), but cases coming to emergency departments were reported in a different database, and test results were reported first to local or state health departments, and then sent up to the CDC.
Covid-19 data in particular has been so messy that volunteer efforts have sprung up to fix it. These include the COVID Tracking Project—compiled from multiple sources and currently the most comprehensive set of statistics, used by media organizations and apparently by the White House—and Covid Exit Strategy, which uses data from the COVID Tracking Project and the CDC.
Last week, the American Public Health Association, the Johns Hopkins Center, and Resolve to Save Lives, a nonprofit led by former CDC director Tom Frieden, released a comprehensive report on Covid-19 data collection. Pulling no punches, they called the current situation an “information catastrophe.”
The US, they found, does not have national-, state-, county-, or city-level standards for Covid-19 data. Every state maintains some form of coronavirus dashboard (and some have several), but every dashboard is different; no two states present the same data categories, nor visualize them the same way. The data presented by states is “inconsistent, incomplete, and inaccessible,” the group found: Out of 15 key pieces of data that each state should be presenting—things such as new confirmed and probable cases, new tests performed, and percentage of tests that are positive—only 38 percent of the indicators are reported in some way, with limitations, and 60 percent are not reported at all.
“This is not the fault of the states—there was no federal leadership,” Frieden emphasized in an interview with WIRED. “And this is legitimately difficult. But it’s not impossible. It just requires commitment.”
But the problem of incomplete, messy data is older and deeper than this pandemic. Four scholars from the health-policy think tank the Commonwealth Fund called out the broader problem just last week in an essay in The New England Journal of Medicine, naming health data as one of four interlocking health care crises exposed by Covid-19. (The others were reliance on employer-provided health care, financial losses in rural and primary-care practices, and the effect of the pandemic on racial and ethinic minorities.)
“There is no national public health information system—electronic or otherwise—that enables authorities to identify regional variation in the demand for, and supply of, resources critical to managing Covid-19,” they wrote. The fix they recommended: a national public health information system that would record diagnoses in real time, monitor the materials hospitals need, and link hospitals and outpatient care, state and local health departments, and laboratories and manufacturers to maintain real-time reporting on disease occurrence, preventive measures, and equipment production.
They are not the first to say this is needed. In February, 2019, the Council of State and Territorial Epidemiologists launched a campaign to get Congress to appropriate $1 billion in new federal funding over 10 years specifically to improve data flows. “The nation’s public health data systems are antiquated, rely on obsolete surveillance methods, and are in dire need of security upgrades,” the group wrote in its launch statement. “Sluggish, manual processes—paper records, spreadsheets, faxes, and phone calls—still in widespread use, have consequences, most notably delayed detection and response to public health threats.”
Defenders of the HHS decision to switch data away from the CDC say that improving problems like that is what the department was aiming for. (“The CDC’s old hospital data-gathering operation once worked well monitoring hospital information across the country, but it’s an inadequate system today,” HHS assistant secretary for public affairs Michael Caputo told CNN.) If that’s an accurate claim, during a global pandemic is a challenging time to do it.
“We were opposed to this, because trying to do this in the middle of a disaster is not the time,” says Georges Benjamin, a physician and executive director of the American Public Health Association, which was a signatory to the letter protesting moving data from the NHSN. “It was just clearly done without a lot of foresight. I don’t think they understand the way data moves into and through the system.”
The past week has shown how correct that concern was. Immediately after the switch, according to CNBC, states were blacked out from receiving data on their own hospitals, because the hospitals were not able to manage the changeover from the CDC to the HHS system. On Tuesday, Ryan Panchadsaram, cofounder of Covid Exit Strategy and former deputy chief technology officer for the US, highlighted on Twitter that data on the HHS dashboard, advertised as updating daily, was five days old. And Tuesday night, the COVID Tracking Project staff warned in a long analysis: “Hospitalization data from states that was highly stable a few weeks ago is currently fragmented, and appears to be a significant undercount.”
When the Covid-19 crisis is over, as everyone hopes it will be someday, the US will still have to wrestle with the questions it raised. One of those will be how the richest country on the planet, with some of the best clinical care in the world, was content with a health information system that left it so uninformed about a disease affecting so many of its citizens. The answer could involve tearing the public-health data system down and building it again from scratch.
“This is a deeply entrenched problem, where there is no single person who has not done their job,” Rivers says. “Our systems are old. They were not updated. We haven’t invested in them. If you’re trying to imagine a system where everyone reports the same information in the same way and we can push a button and have all the information we might want, that will take a complete overhaul of what we have.”