Florida’s COVID Response Includes Missing Deadlines and Data

Blog | Florida's COVID-19 Data: What We Know, What's Wrong, and What's  Missing | The COVID Tracking Project

 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.

Updates Delayed

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.”

The norms around science and politics are cracking

https://www.axios.com/science-politics-norms-cracking-f67bcff2-b399-44f4-8827-085573f5ae52.html

Illustration of a hand holding a cracked microscope slide containing the U.S. flag.

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.

  • Those agencies might handle the order differently, and it is unclear how many positions could fall under Schedule F — but some say possibly thousands.
  • “This much-needed reform will increase accountability in essential policymaking positions within the government,” OMB director Russ Vought tells Axios in a statement.

What they’re saying: Several medical associations, including the Infectious Diseases Society of America, strongly condemned the action, and Democrats on the House oversight panel demanded the administration “immediately cease” implementation.

  • “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.

The COVID Tracking Project

https://covidtracking.com/data/charts/us-daily-positive

The public deserves the most complete data available about COVID-19 in the US. No official source is providing it, so we are.

Every day, our volunteers compile the latest numbers on tests, cases, hospitalizations, and patient outcomes from every US state and territory.

https://covidtracking.com/

Convalescent Plasma: The Unanswered Questions

https://www.medpagetoday.com/infectiousdisease/covid19/88264?xid=fb_o&trw=no&fbclid=IwAR0F6xiRAQ7ngBz4pNozJ2VqWm0-UJqGdlQojfOeyXbPJjbAeYtGL8jbAiw

“The data don’t show anything useful”

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.

That figure quickly came under fire, leading to an apology from Commissioner Stephen Hahn, MD — but that’s not the only criticism leveled at the FDA’s analysis of the available data.

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.”

 

 

 

 

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

Billions in Hospital Virus Aid Rested on Compliance With Private ...

The Department of Health and Human Services told hospitals in April that reporting to the vendor, TeleTracking Technologies, was a “prerequisite to payment.”

The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.

The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.

The office of the health secretary, Alex M. Azar II, laid out the requirement in an April 21 email obtained by The New York Times that instructed hospitals to make a one-time report of their Covid-19 admissions and intensive care unit beds to TeleTracking Technologies, a company in Pittsburgh whose $10.2 million, five-month government contract has drawn scrutiny on Capitol Hill.

“Please be aware that submitting this data will inform the decision-making on targeted Relief Fund payments and is a prerequisite to payment,” the message read.

The financial condition, which has not been previously reported, applied to money from a $100 billion “coronavirus provider relief fund” established by Congress as part of the $2.2 trillion Coronavirus Aid, Relief and Economic Security Act, or CARES Act, signed by President Trump on March 27. Two days later, the administration instructed hospitals to make daily reports to the C.D.C., only to change course.

“Another data reporting ask,” a regional official in the health department informed colleagues in an email exchange obtained by The Times, adding: “It comes with $$ incentive. We really need a consolidated message on the reporting/data requests, this is past ridiculous.”

A colleague replied, “Another wrinkle. What a mess.”

The disclosure of the demand in April is the most striking example to surface of the department’s efforts to expand the role of private companies in health data collection, a practice that critics say infringes on what has long been a central mission of the C.D.C. Last month, the federal health department moved beyond financial incentives and abruptly ordered hospitals to send daily coronavirus reports to TeleTracking, not the C.D.C., raising concerns about transparency and reliability of the data.

Officials at the Department of Health and Human Services say that the moves were necessary to improve and streamline data collection in a crisis, and that the one-time reports collected in April by TeleTracking were not available from any other source.

“The national health system has not been challenged in this way in any time in recent history,” Caitlin Oakley, a department spokeswoman, said in a statement, adding that TeleTracking offered a “standardized national hospital capacity tracking system which provided more real-time, better informed data to make decisions from.”

But critics remain alarmed.

“In the middle of a pandemic, the Trump administration is using funds meant to support hospitals as a tool to coerce them to use an unproven, untrusted and deeply flawed system that sidelines public health experts,” Senator Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, said in a statement.

In a statement, TeleTracking said it has three decades of experience providing health care systems “with actionable data and unprecedented visibility to make better, faster decisions.”

Still, public health experts and hospital executives are puzzled as to why the health agency chose such a difficult time to employ an untested private vendor rather than improve the C.D.C.’s National Healthcare Safety Network, a decades-old disease tracking system that was deeply familiar to hospitals and state health departments.

The N.H.S.N., as it is known, had built up trust over decades of working with hospitals and state health departments. Administrators were reluctant to make the switch.

“People — especially in public health and clinical health — are very protective of their data, so that trust factor is certainly an issue,” said Patina Zarcone, the director of informatics for the Association of Public Health Laboratories. “The fear of having their data leaked or misused or used for a purpose that they weren’t aware of or agreed to — I think that’s the biggest rub.”

Ms. Oakley said the C.D.C.’s system was “not designed for use in a disaster response” and could not adapt quickly in a crisis. Allies of the C.D.C. say withholding taxpayer dollars from the CARES Act in lieu of cooperation was an inappropriate effort to push hospitals into a system they were reluctant to use.

“It’s an absolutely enormous lever,” said William Schaffner, an infectious disease expert at Vanderbilt University. “It’s a compulsion to oblige institutions to report to this TeleTracking system because they knew if it weren’t tied to money, it wouldn’t happen.”

The Pittsburgh company has no obvious ties to the Trump administration. Rather, the push appears to be part of a broader privatization. The Health and Human Services Department has also asked the Minnesota-based manufacturer 3M “to create, and continuously update, a nationwide clinical data set on Covid-19 treatment,” according to documents obtained by The Times.

The effort is separate from the TeleTracking data collection. Tim Post, a company spokesman, said that because 3M already operates hospital information systems, it is “uniquely positioned,” with the permission of its clients, to submit information to the health department to help officials study disease patterns and recommend treatment options.

Some experts say this kind of cooperation with the private sector is long overdue. But the push also appears to be driven at least in part by an intensifying rift between the C.D.C., based in Atlanta, and officials at the White House and Department of Health and Human Services, the parent agency of the disease control centers.

Dr. Deborah L. Birx, the White House coronavirus response coordinator, and Mark Meadows, the president’s chief of staff, have taken a dim view of the C.D.C. and believe its reporting systems were inadequate. In a recent interview, Michael Caputo, the spokesman for Mr. Azar, accused the C.D.C. of having “a tantrum.”

Accurate hospital data — including information about coronavirus caseloads, deaths, bed capacity and personal protective equipment — is essential to tracking the pandemic and guiding government decisions about how to distribute scarce resources, like ventilators and the drug remdesivir, the only approved treatment for hospitalized Covid-19 patients.

The health agency has set up a new database, H.H.S. Protect, to collect and analyze Covid-19 data from a range of sources. TeleTracking feeds hospital data to that system.

But the public rollout of H.H.S. Protect has been rocky. The nonpartisan Covid Tracking Project identified big disparities between hospital data reported by states and the federal government and deemed the federal data “unreliable.”

The tension dates to March, when the novel coronavirus was making its first surge in the United States

On March 29, Vice President Mike Pence, charged by Mr. Trump with overseeing the federal response, informed hospital administrators that the C.D.C. was setting up a “Covid-19 Module,” and asked them to file daily reports which, he said, were “necessary in monitoring the spread of severe Covid-19 illness and death as well as the impact to hospitals.”

But around that time, TeleTracking submitted a proposal for data collection to the Trump administration, through an initiative, ASPR Next, created to promote innovation. On April 10, TeleTracking was awarded its contract.

The health department’s spokeswoman said the intent was to complement the C.D.C., not compete with it. Like the C.D.C.’s network, TeleTracking’s system requires manual reporting on a daily basis. But in June, Ms. Murray demanded the administration provide more information about what she called a “multimillion-dollar contract” for a “duplicative health data system.”

Some hospital officials also objected to the change.

“We have been directing our hospitals to N.H.S.N.,” Jackie Gatz, a vice president of the Missouri Hospital Association, wrote to a regional health and human services official in an email obtained by The Times, “and now this email with a much greater carrot — CARES Act distributions — is routing them to TeleTracking.”

When the order was delivered, flaws had already emerged in the new system.

“H.H.S. has acknowledged long wait times for those calling for technical support, and indicated that TeleTracking recently added 100 staff to respond to call center requests,” the American Hospital Association wrote to its members in a “special bulletin” on April 23. “They also are directing hospitals to leave a message if they are unable to reach someone live.”

At the time, hospitals had the option of making their daily coronavirus reports to TeleTracking or the C.D.C. Few were using the new database.

In June, the administration again used a stick to demand that hospitals report to TeleTracking, this time in order to obtain remdesivir. By July, with Dr. Birx pushing to bolster hospital compliance, the administration instructed hospitals to stop filing daily reports to the C.D.C. and to send them to TeleTracking instead.

One official at a major academic hospital, who spoke on the condition of anonymity for fear of angering officials in Washington, said the switch left her “unable to sleep at night.”

“Ethically, it felt like they had taken a very trusted institution in the C.D.C. and all of that trust built up with many public health people,” she said, then “moved it onto a politically and financially motivated portion of this response.”

Health and human services officials say the government now has a much more complete picture of hospital bed capacity, with more than 90 percent of hospitals reporting. But Dr. Janis M. Orlowski, the chief health officer for the Association of American Medical Colleges, who worked with Dr. Birx and the administration to bolster hospital reporting, said that she was “stunned” by the switch and that the increase in reporting came because of efforts by her group and others, not the TeleTracking system.

Dr. Orlowski said the data and maps now published on the administration’s H.H.S. Protect data hub are “just not as sophisticated as the C.D.C.”

The switch also generated pushback inside the C.D.C., where officials have refused to analyze and publish TeleTracking data, saying they could not be assured of its quality and had continuing questions about its accuracy, according to a senior federal health official.

Administration officials say the C.D.C. is working with a little-known office in the executive branch — the United States Digital Service — to build a “modernized automation process” in which data will continue to flow directly to the Department of Health and Human Services. But the project is in its infancy, one senior federal health official said.

Critics say that if the department believed the C.D.C.’s health network had problems, those should have been fixed.

“We have a public health system that depends upon communication from hospitals to state health departments to the C.D.C.,” said Dr. Schaffner, the Vanderbilt University infectious disease expert. “It’s very well established. Can it be improved? Of course. But to cut out the public health infrastructure and report to a private firm essential public health data is misguided in the extreme.”

 

 

 

Healthcare mergers and acquisitions require sensible data sharing strategies, and a solid analytics framework

https://www.healthcarefinancenews.com/news/healthcare-mergers-and-acquisitions-require-sensible-data-sharing-strategies-and-solid?mkt_tok=eyJpIjoiTmpJME5qVTNOVEU1TXpRdyIsInQiOiJDdUIxQ1NKdng1b0FkQ1wvQlwvNFBTc1JIbmVwYUZOeUhCZ3VlNlZzdmhNbkhBQlhnXC9JeTI4c2NDeE80REk0YWJ1Nk1jSzl4QjFDbjFMTkxKdmVCblY1RUlSYTIwUmlhSEJ6VXpkOUZZdytUWDhaV1poaEljcVh5ZFdEOUdVZlQzZyJ9

While it’s important for disparate EHRs to communicate with one another, organizations need a better handle on analytics and dashboards.

Mergers and acquisitions in healthcare have been going along at a pretty good clip for a number of years now. The volume of deals remains high, and with larger entities primed to scoop up some of their smaller, struggling peers, the trend seems poised to continue.

There’s an issue that consolidating organizations consistently run into, however: data sharing.

Specifically, many organizations that have initiated merger activity fail to consider that not only will the consolidation necessitate integrating multiple electronic health records, but other ancillary systems as well.

These organizations need to produce the analytics that are required to manage what’s essentially a new business, and that starts with the development of some sort of analytics blueprint early on in the merger activity.

As two or more forces join into one, it’s important to have the analytics blueprint in place so leaderships knows which dashboards are going to be needed for success.

“There used to be a trend where everyone was converted onto the same EHR platform,” said John Walton, solutions architect for IT consulting company CTG. “I guess the thought is that if everyone is converted, the problem will go away. Now … they end up in a situation where they can’t produce the kind of dashboards that are needed.”

THE FRAMEWORK

A key component of an effective analytics blueprint is a conceptual data model — basically a visual representation of what domains are needed for the dashboards.

“It sounds difficult to produce, but if it takes more than four to six weeks to produce something like that, you’re overthinking it,” said Walton. “But that’s then starting point. The key component is that analytics framework.”

Failure to have a framework in place can result in the newly merged entity losing out in terms of revenue and productivity. And once the problem becomes manifest, there’s often a lot of manual effort that goes into serving, for example, the financial dashboards that are so needed by CFOs. A lot of the manual effort goes into putting the data into Excel spreadsheets, which only puts a Band-Aid on the problem.

“The framework essentially provides pre-built routines to extract data from multiple data sources, as well as from financial systems,” said Walton. “It also provides, for lack of a better term, the data plumbing to enterprise standards, and most importantly there’s an analytic layer. The endgame is that the dashboards need to sit on top of an analytics layer that is easy to do analytics on. What it contains is pre-computed performance indicators based on approved business rules with multiple levels of aggregation.”

An effective framework, as with so many other things, begins with C-suite leadership. Having executive sponsorship, or at least an understanding of the issue at an executive level, can translate into a vision for how to integrate the data and provide the analytics that are needed to successfully manage the business.

PLANNING PROACTIVELY

Walton once observed a national organization that acquired another entity, and after two years the CEO still didn’t have any executive dashboards — which means a lack of visibility into the performance metrics. The CEO hen issued what was effectively a mandate to the acquiring organization: Get this done within three months, or else.

Thus began a flurry of activity to et the dashboard situation straightened out, which is not where an organization wants to be. Proactive planning is essential, yet Walton doesn’t see a lot of that in healthcare.

“I’ve never seen an organization proactively plan for this,” he said. “That doesn’t mean it’s not happening, but in my experience I haven’t seen it.”

In the meantime, mergers and acquisitions keep happening. Even if merging organizations become aware of the problem and factor that into their decision-making there’s another issue to consider.

“Another extremely significant problem is data quality and information consistency,” said Walton. “That problem really is not universally dealt with, in healthcare or for that matter other industries. It’s almost like they’ve learned to live with it. It’s almost like we need a call to arms or something. You’re almost certainly going to have the need for an analytics framework that will apply the data to your standards.”

The data in question could encompass missing or clinically inappropriate data. Quality, in this case, has to do with the cleanliness of the data. In terms of consistency, a good example would be something like average length of stay. There’s an opportunity to ensure that the right data ownership and stewardship is in place.

Importantly, it’s primarily a business solution. It’s possible that one of the merging entities has a data governance strategy, but all too often that strategy was launched by the IT department — which is not where an organization wants to be, said Walton, because it’s primarily a business problem rather than one that’s purely technical.

Data governance is a very well-known concept, but people struggle with its actual implementation for a number of reasons,” he said. “One, there’s a technical aspect of it, which centers around how we identify data quality issues. What kinds of tools are they going to use to address data quality issues?

“Then there’s establishing ownership of the data, and who are the subject matter experts. And there’s a workflow aspect that most organizations fail to deal with.”

It all starts with the framework. Only then can merging organizations get an appropriate handle on its data and analytics landscape.