There's a pandemic spreading across the U.S., and amid ongoing struggles to scale up testing, it's still unclear how many people are actually infected.
In the absence of real numbers, projections have filled the void, and I've been struggling as a reporter to know which forecasts to trust. Last week, the Ohio Department of Health said that over 100,000 people were infected, at a time when there were five confirmed cases in the state. Some epidemiology experts critiqued that estimate as too high, and the department's director later said she was "guesstimating."
Should reporters second-guess their health department's figures? When is it safe for me to retweet? I set out to talk to some experts and learned just how fuzzy those forecasts can be. But there are ways we can think about them that help give us more clarity.
It's impossible to know how many people are infected right now. Just know that the number is far higher than the running case count.
It's easier to do big, sweeping projections on a question like how many people will be infected by the time this is all over and done with. Marc Lipsitch, head of the Harvard T.H. Chan School of Public Health's Center for Communicable Disease Dynamics, has been running projections to figure out how many adults across the world will be infected before a vaccine hits the market (one won't be available for at least a year) or herd immunity kicks in — when enough people have developed immunity to the virus, from having caught it, so that it can't easily be transmitted any more. He concluded that between 20% and 60% of adults worldwide will ultimately get infected. (ProPublica has created a tool based on his models and it's worth checking out.)
It's much harder to figure out how many Americans are infected at this very moment. Some states have little information because they've barely started testing and don't know when community transmission began in specific places. Many people with symptoms consistent with COVID-19 were turned away from getting tests.
Caitlin Rivers, a computational epidemiologist at Johns Hopkins Center for Health Security, said she's "not sure we're in a place where we're able to estimate that," though she's confident that there are far more infected people than the number of reported cases at this time. Computational epidemiologist Maia Majumder said that without widespread testing, this is a "really challenging question to pin down."
In short, the best way to actually know is with hard evidence — which means testing. As World Health Organization director general Tedros Adhanom Ghebreyesus saidon Monday: "You cannot fight a fire blindfolded, and we cannot stop this pandemic if we don't know who is infected. We have a simple message for all countries: Test, test, test."
Think in orders of magnitude. The numbers are less precise than they seem.
Of course, computational epidemiologists do have ways of coming up with ballpark estimates. I asked the experts to discuss this sentence with me, from a March 14 postabout New York City's looming crisis by a Facebook data scientist:
"We estimate that between 1,281 and 2,280 people are infected as of yesterday."
That range seems to be both wide yet oddly specific. What is a reader supposed to take away from a sentence like that?
Reporting precise numbers allows epidemiologists to replicate each others' work; rerunning the same equations and arriving at the same results helps to validate findings. Public health officials also need as much information as possible because it's helpful for decision-making about preparing hospital beds or closing schools.
My concern, however, is that a sentence like that can give readers a false sense of precision, as if it's possible to know down to a difference of one or two people. When I asked Rivers what a regular person should take from these counts, she said people should focus on the order of magnitude: "This means there's a couple of thousand people, it's not 200 or 4 million. It means we're in the low thousands."
"If the forecast doesn't state its assumptions, I'd be wary," Majumder said. For example, a popular modeling approach, called the SIR model, assumes that each individual is equally likely to come into contact with any other individual in the population; you don't have to have a Ph.D. to see how that's not very realistic.
Majumder also noted that just because someone is good at math doesn't mean that they're equipped to do epidemiological forecasting, which comes with its own nuances. "Has the author published epidemiological modeling studies – preferably of other emerging infectious diseases – before in peer-reviewed literature?"
My advice: Check who the numbers are coming from before repeating them.
Don't get hung up on the specifics. The big picture is clear.
Trying to get clarity on exactly how many people are infected in your city shouldn't be your goal, if you're a regular member of the public. Rivers and Majumder agreed on this: There's no difference in what action you need to take, whether the models say there will be 10,000 or 20,000 infections in your state within a certain number of days or weeks.
There isn't a single expert I've talked to who said case counts won't continue to soar. There are two reasons for this: As testing becomes more available, cases that already exist will be revealed. Secondly, of course, the virus is continuing to spread. The trends are crystal clear, and the call to action is indisputable. "If your state has reported community transmission, the message is the same no matter the number of cases: engage in social distancing immediately," Majumder said.
Public health experts agree that Americans need to stay home as much as possible, but the Trump administration has not yet issued clear guidance to federal workers.
In some ways, the United States is lucky, because the disease arrived here later than it did in China or Italy. We don't need to rely on computer models to guess what we have to do. We can look to other countries that have been dealing with the virus longer than us.
Rivers points to some countries in Asia that have taken sweeping measures, including closing schools, testing en masse and even publishingthe past whereabouts (without names) of people who tested positive, as in South Korea — from the restaurants people visited to the specific seats they sat in at movie theaters.
"They took these interventions really seriously and were really committed in order to avoid a scenario like Italy," she said. "That's really what we should be focusing on as a country."
For reporters, this means two things: Of course, we should continue to ask public officials to explain where they get their numbers from and run them by experts before publication whenever possible. But more crucially, the press needs to hold those in power accountable for their actions — or lack thereof. While it's forgivable to put out a bad estimate, it's unforgivable to not act in the face of a pandemic that is not just at our doorstep, but already inside our house.
Each of us has the power to help flatten the curve.
I'm sure by now you've already heard about this notion, which comes with its own hashtag. In a nutshell, to avoid a spike of critical cases that will overload our hospitals, we need to implement mitigation strategies to slow down disease transmission.
For the past week, my email inbox has been a sea of panic. A woman in California wrote that she is the full-time caregiver for her elderly mother and is terrified of infecting her. Should she wear gloves at all times, even to touch the mail? Should she never leave the house? A New England retail worker described her fear while ringing people up all day, but said: "I need the money for my bills. I don't know what to do." A hospital administrator trying to secure supplies for her facility told me: "I can't lose my job. I can't lose my life insurance. If I die, I need my child taken care of."
How soon regions run out of hospital beds depends on how fast the novel coronavirus spreads and how many open beds they had to begin with. Here's a look at the whole country. You can also search for your region.
On Saturday night, after reading too many of these messages in one go, I cried, knowing there was so little I could do to actually help and feeling overwhelmed by how large the problem felt.
But the next morning, I woke up to Berlin-based reporter Kai Kupferschmidt's suggestion that we all share "positive or practical things" that we'd seen or done, big or small, "to adapt to this new world we find ourselves in." For the first time in a while, bright spots illuminated my computer screen. A member of my book club emailed everyone offering to help buy food and supplies. Dr. Esther Choo, an associate professor of emergency medicine, tweeted: "Medical students around the country, taken off clinical rotations due to #COVID, have set up babysitting networks to support essential hospital staff." All these stories cheered me immensely and encouraged me that I didn't have to sit back helplessly; I could take small actions myself.
When forecast figures are being thrown around — thousands and hundreds of thousands and millions of people — it can be hard for them to feel real. But when I remind myself that all these fearful and anxious and generous and compassionate people are who we're all fighting for, it's a no-brainer as to why I should stay at home, even if I am young and healthy.
The curve will certainly rise for the next few weeks. There will be more fear-inducing headlines that give us reason to doubt the level of preparedness. But know that our individual actions — staying home, enabling health care workers by not hoarding supplies like masks, doing what we can to take care of the most vulnerable in our society — can all help flatten that curve. I hope that our collective efforts mean that it will not rise for too long, and it will not be too steep. In the meantime, take care, and be well.
A federal directive that's supposed to speed up the response to a pandemic is actually slowing down the government's rollout of coronavirus tests.
The directive, issued by the U.S. Food and Drug Administration, requires that the Centers for Disease Control and Prevention, a sister agency, retest every positive coronavirus test run by a public health lab to confirm its accuracy. The result, experts say, is wasting limited resources at a time when thousands of Americans are waiting in line to get tested for COVID-19.
The duplicative effort is the latest obstacle that is slowing the federal response to COVID-19, which has infected more than 1,300 people and resulted in 38 deaths in the United States. Progress was already delayed because the CDC decided to make its own test rather than adopting the design endorsed by the World Health Organization. The test then didn't work properly and had to be fixed. The problems were further compounded by delays in certifying tests by private laboratories as well as a shortage of supplies and raw materials used for testing.
On Feb. 4, the FDA, which regulates devices as well as drugs, released a document called an Emergency Use Authorization to govern the use of the test. The goal of the emergency authorization is to short-circuit the typically onerous regulatory review that the agency imposes on new diagnostic devices — a process that can take months to years.
In the face of an imminent outbreak, however, the stringently written EUA appears to have become more of a hindrance than a help. Because of the requirement that the CDC rerun tests conducted by public health labs, as of two weeks ago the CDC's website was lagging in its tally because it was only reporting confirmed cases. The CDC is now reporting both presumptive positives, which have been tested only by local labs, as well as cases it has confirmed.
"This is the time when we need as many tests as we can very quickly, because we need to know what is happening in this country," said Dr. Leana Wen, an emergency physician and former health commissioner for the city of Baltimore. "Right now we are in the dark about the degree of COVID-19 spread. It's hard for us to proceed to do our work in public health without concrete information."
The CDC says it is simply following the process set out by federal regulations, though it couldn't say how many false positives, if any, have shown up in the verification process.
"The regulatory language of the EUA dictated that," CDC spokesman Richard Quartarone said. "We have to follow the rules. If we don't follow the rules, FDA could shut us down. That is a real thing."
The CDC is designed to serve as a short-term bridge to widespread testing while it analyzes a new disease and makes sure diagnostic tests are working correctly before handing the role off to the private sector, Quartarone said. If duplication hadn't been required, the CDC may have been able to help with more front-line testing before private-sector labs took over, he said.
The emergency authorization also slowed the process of tests offered by private labs, which became available last week. The FDA initially required private labs to copy the CDC's test design and have the agency review their tests before allowing them to begin testing. It took more than three weeks and growing criticism for the FDA to update its guidelines to allow certain academic labs to start testing once they had validated their tests internally.
In response to questions, FDA spokeswoman Stephanie Caccomo referred a reporter to a speech by FDA Commissioner Stephen Hahn on March 7, in which he defended the agency's process.
"In the U.S., we have policies in place that strike the right balance during public health emergencies of ensuring critical independent review by the scientific and public health experts and timely test availability," Hahn said. "The CDC test is a high-quality test, and it's important to remember that false negatives or positives can be detrimental to making sure we are treating patients early, without delay, and also not quarantining healthy individuals."
Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins' School of Public Health, said the FDA's high standards might have been appropriate for smaller outbreaks. The FDA issued EUAs for diagnostics during the 2014 Ebola crisis and in 2016 for the mosquito-borne Zika virus. The coronavirus, however, is moving too fast to maintain absolute control — and the FDA could have ordered up a more flexible process, Scharfstein said.
"If you were to go back in time and tell the FDA 'you've got a month to get a million tests ready,' I imagine they wouldn't have chosen this strategy," said Sharfstein, who oversaw EUAs while he served as deputy commissioner of the FDA during the Obama administration.
The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn't trust the test's accuracy.
Requiring confirmatory tests not only adds time to the process but also uses crucial chemicals needed to set up the tests. "You need some of the reagents that now are in short supply to prepare the tests," said CDC Director Robert Redfield in ahearing before the House Oversight Committee on Thursday, explaining the difficulty in expanding capacity even as private labs received green lights to start testing.
Private labs need only get confirmation for their first five positive and first five negative clinical specimens, according to the FDA's Feb. 29 guidance. Commercial giants like LabCorp and Quest Diagnostics say they are now able to run thousands of tests a day.
"We want them to come online, because we don't have the manufacturing capacity; our system in place is not designed for that massive amount," Quartarone said of the private labs. "In general, CDC testing is a drop in the bucket for the overall testing that happens."
According to the American Enterprise Institute, as of Thursday afternoon, nationwide testing capacity was at about 20,695 people a day. California public and private labs accounted for 39% of capacity, and the CDC and public health labs together accounted for about 17% of available tests.
That's only testing capacity, however. According to Redfield, actual testing is still hampered by shortages of essential equipment and manpower.
An outbreak would demand peak performance from America's medical professionals — especially in hospitals. But many of the facilities that may be on the front lines have well-documented histories of failing to prevent the spread of infectious diseases.
This article was first published on Tuesday, March 3, 2020 in ProPublica.
In early February, Royal Caribbean's Anthem of the Seas docked in Bayonne, New Jersey, in need of a hospital. The cruise ship was carrying patients who had traveled from China, where an outbreak of COVID-19 had taken root. Four passengers needed to go somewhere for further medical observation.
The obvious next step was University Hospital in Newark, a major academic medical center equipped with isolation rooms. "The hospital is following proper infection control protocols while evaluating these individuals," Gov. Phil Murphy said in a statement. The patients tested negative, but the governor was clear. The state's first coronavirus cases would go to University.
That's a hospital that has struggled in recent years with a critical skill essential to battling COVID-19: controlling the spread of infection.
Less than two years ago, a deadly bacteria made its way through the facility. Three babies in the neonatal intensive care unit got infected and died. Government inspectors cited the hospital for being short of staff; failing to maintain a sanitary environment, including improper hand hygiene and sterilization; and inadequately isolating patients with respiratory conditions. They determined the hospital had put patients in "immediate jeopardy."
Today, the state's former health commissioner, Dr. Shereef Elnahal, is in charge of the hospital. He told ProPublica its infection control problems are a thing of the past. The violations cited in the report were corrected with increased screening of patients, improved handwashing and equipment and focused leadership, Elnahal said. "I'm proud of our progress since then," he said. Murphy's office directed inquiries to the state's Department of Health, where a spokeswoman said there is "complete confidence" in the hospital's ability to manage the coronavirus response.
But infection control has been a recurring problem at some of the very hospitals that would likely be called upon to treat COVID-19 patients, a ProPublica review of hundreds of hospital inspection reports found. This raises concerns that they could become hotbeds for disease, putting patients at risk and rendering infected workers unable to care for others.
"Health care workers are my top worry," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. He noted that in China, so far, about 15% of infected hospital workers have become severely ill. "If this takes place in the U.S., and we see those numbers of workers sent home or in the ICU, being taken care of by their colleagues, things will start to unravel. This is the soft underbelly of our preparedness system right now."
At least two health care workers in Northern California had preliminary positive tests for COVID-19 at NorthBay VacaValley Hospital, pending CDC confirmation. The hospital had treated a patient who later tested positive for the disease. Other health care workers who came into contact with the patient are also in quarantine.
There is no list of designated centers to handle the most critical COVID-19 patients, experts said. But the Centers for Disease Control and Prevention, during the 2014-16 Ebola outbreak, named 55 hospitals it considered to be in the first tier of treatment centers to handle that kind of crisis — mostly large, urban teaching hospitals capable of complex care like blood transfusions and ventilation.
ProPublica analyzed five years of federal hospital inspection reports for these facilities and found violations for infection control failures or other factors that could hamper the response to an outbreak at more than half of them. About 1 in 5 of the facilities had four or more violations; the analysis found more than a hundred overall. It's not clear by looking at the reports how many of the violations led to patient infections. Problems that get cited on the inspection reports are required to be corrected as part of the regulation process.
But it's also true that inspections only flag a small number of the actual problems in hospitals. American hospitals, overall, are so bad at preventing infections that hospital-acquired infections are considered a leading cause of death in the United States. The hope would be that the sites designated as specialized infection-control centers would do better.
MedStar Washington Hospital Center in Washington, D.C., says it's ready to screen coronavirus patients. Inspectors have cited the facility more than a dozen times since 2017, including for infection control failures. Among the violations: Staff did not wear and dispose of masks according to federal guidelines. Short staffing caused scores of patients to go without respiratory treatments. There were sewage leaks in operating rooms.
In an email, a spokeswoman said the hospital has addressed the failures: "We maintain a constant state of readiness for treating complex illnesses, including the coronavirus."
Montefiore Medical Center in the Bronx, New York, says on its website COVID-19 patients will be immediately isolated. But it got written up back-to-back, in 2016 and 2017, for violating infection control protocol. Among the shortcomings: "Chronic overcrowding" in its emergency room, not isolating a Hepatitis B-positive patient and contaminated supplies. Infection control breaches put patients and staff at risk, one inspection report said. Hospital officials did not respond to requests for comment.
Medical experts say they wonder: if hospitals can't control the spread of pathogens under normal conditions, what happens if they face a rush of patients with a disease as contagious and serious as the one caused by COVID-19?
During the SARS outbreak in the greater Toronto area, 44% of the total cases were among health care workers. A retrospective study, published in the journal Emerging Infectious Diseases in 2004, hypothesized that "lapses in infection control measures may be responsible," noting that caregivers were particularly at risk during procedures like intubation.
Though COVID-19, with its estimated 2% fatality rate, is far milder than SARS, which killed about 10%, it is thought to have a similar methodof transmissionand will require similar methods of protection to prevent the disease from spreading throughout hospitals. Without a proven treatment or vaccine, infected patients would need to be handled with the utmost caution. They would be isolated, and caregivers would don protective gear, including gloves, goggles, gowns and masks.
Medical providers across the country told ProPublica that they're worried about their safety and their hospitals' lack of preparation. They spoke on the condition of anonymity because they were not authorized to speak on behalf of their hospitals.
The coronavirus arrived in Washington state "like a slap in the face," a nurse in the Seattle area told ProPublica. Two weeks ago, her hospital was talking about the virus as something it was "watching, but with no big alarm." Now, the state has had the first deaths in the United States and 18 confirmed cases as of Monday. The hospital is "desperately trying to get more supplies," she said, particularly of masks and gowns. She fears that morale will drop. Already, she's heard staff grumbling that only certain units are being allocated higher-protection masks.
An acute-care nurse in Rockford, Illinois, said that just last week, a severely ill patient on her floor initially tested negative for the flu but after nearly a week retested positive. In that period, nurses were in and out of his room, and what's known as "droplet precautions" weren't always taken — for example, sometimes the patient didn't have a mask on, meaning staff members were exposed. "How easily this happened gives me serious concerns about the much more serious infection we face with COVID-19," she said.
Another nurse, at a high-level hospital in western New York that is likely to handle severely ill patients, said the only information he's received is via the hospital's internal newsletter. "Management has just said, 'We're monitoring the situation and we'll keep you updated.' It's ridiculous. They haven't verbalized a specific plan, and that increases the anxiety of a lot of the care providers." He said he and his co-workers are "resigned to the fact that we're all going to get the coronavirus."
The risk to hospital workers could have a dangerous cascading effect, said Dr. Lance Peterson, the recently retired director of clinical microbiology and infectious disease research at the NorthShore University Health System in Evanston, Illinois. He said that hospitals often keep staffing to a minimum, and that could become a problem if there's prolonged spread of the virus. "If hospital workers start getting sick," he said, "you don't want them to come to work."
Some hospitals are more prepared than others for a potential outbreak, said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. Some have spent recent weeks running drills. Officials at University Hospital in Newark and MedStar in Washington, D.C., count themselves among those.
In many ways, the United States is better prepared than many other countries for an outbreak, Peterson said. Individual patient rooms are common, which makes it easier to isolate infected patients. The SARS and Ebola outbreaks prompted many hospitals to stock up on supplies like gloves and gowns and masks, he said. And The Joint Commission, which accredits hospitals, has been monitoring their level of preparation.
But it is true there are also going to be infection control problems, he said. "Whenever you have humans in the system, there will be lapses."
The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn't trust the test's accuracy.
This article was first published on Friday, February 28, 2020 in ProPublica.
As the highly infectious coronavirus jumped from China to country after country in January and February, the U.S. Centers for Disease Control and Prevention lost valuable weeks that could have been used to track its possible spread in the United States because it insisted upon devising its own test.
The federal agency shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn't work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.
As a result, until Wednesday the CDC and the Food and Drug Administration only allowed those state labs to use the test — a decision with potentially significant consequences. The lack of a reliable test prevented local officials from taking a crucial first step in coping with a possible outbreak — "surveillance testing" of hundreds of people in possible hotspots. Epidemiologists in other countries have used this sort of testing to track the spread of the disease before large numbers of people turn up at hospitals.
This story is based on interviews with state and local public health officials and scientists across the country, which, taken together, describe a frustrating, bewildering bureaucratic process that seemed at odds with the urgency of the growing threat. The CDC and Vice President Mike Pence's office, which is coordinating the government's response to the virus, did not respond to questions for this story. It's unclear who in the government originally made the decision to design a more complicated test, or to depart from the WHO guidance.
"We're weeks behind because we had this problem," said Scott Becker, chief executive officer of the Association of Public Health Laboratories, which represents 100 state and local public laboratories. "We're usually up-front and center and ready."
The CDC announced on Feb. 14 that surveillance testing would begin in five key cities, New York, Chicago, Los Angeles, San Francisco and Seattle. That effort has not yet begun.
On Wednesday, under pressure from health experts and public officials, the CDC and the FDA told labs they no longer had to worry about the portion of the test intended "for the universal detectionof SARS-like coronaviruses." After three weeks of struggle, they could now use the test purely to check for the presence of COVID-19.
It remains unclear whether the CDC's move on Wednesday will resolve all of the problems around the test. Some local labs have raised concerns about whether the CDC's test is fully reliable for detecting COVID-19.
In New York, scientists at both the city's and state's laboratories have seen false positives even when following the CDC's latest directions, according to a person familiar with their discussions.
"Testing for coronavirus is not available yet in New York City," city Department of Health spokeswoman Stephanie Buhle said in an email late Thursday. "The kits that were sent to us have demonstrated performance issues and cannot be relied upon to provide an accurate result."
Until the middle of this week, only the CDC and the six state labs — in Illinois, Idaho, Tennessee, California, Nevada and Nebraska — were testing patients for the virus, according to Peter Kyriacopoulos, APHL's senior director of public policy. Now, as many more state and local labs are in the process of setting up the testing kits, this capacity is expected to increase rapidly.
So far, the United States has had only 15 confirmed cases, a dozen of them travel-related, according to the CDC. An additional 45 confirmed cases involve people returning to the U.S. having gotten sick abroad. But many public health experts and officials believe that without wider testing the true number of infected Americans remains hidden.
"The basic tenet of public health is to know the situation so you can deal with it appropriately," said Marc Lipsitch, professor of epidemiology at the Harvard T. H. Chan School of Public Health. He noted that Guangdong, a province in China, conducted surveillance testing of 300,000 people in fever clinics to find about 420 positive cases. Overall, Guangdong has more than 1,000 confirmed cases. "If you don't look, you won't find cases," he said.
Janet Hamilton, senior director of Policy and Science at Council of State and Territorial Epidemiologists, said that with the virus spreading through multiple countries, "now is the time" for widespread surveillance testing.
"The disease," she said, "is moving faster than the data."
It remains to be seen what effect the delay in producing a working test will have on the health of Americans. If the United States dodges the rapidly spreading outbreaks now seen in Iran and South Korea, the impact will be negligible. But if it emerges that the disease is already circulating undetected in communities across the country, health officials will have missed a valuable chance to lessen the harm.
The need to have testing capacity distributed across local health departments became even more apparent Wednesday, when the CDC said it was investigating a case in California in which the patient may be the first infected in the United States without traveling to affected areas or known exposure to someone with the illness.
Doctors at the University of California, Davis Medical Center, where the patient is being treated, said testing was delayed for nearly a week because the patient didn't fit restrictive federal criteria, which limits tests only to symptomatic patients who recently traveled to China.
"Upon admission, our team asked public health officials if this case could be COVID-19," UC Davis said in a statement. UC Davis officials said because neither the California Department of Public Health nor Sacramento County could test for the virus, they asked the CDC to do so. But, the officials said, "since the patient did not fit the existing CDC criteria for COVID-19, a test was not immediately administered."
After this case, and under pressure from public officials, the CDC broadened its guidelines Thursday for identifying suspected patients to include people who had traveled to Iran, Italy, Japan or South Korea.
The debate over whether federal, state and local officials should have already been engaged in widespread surveillance testing has become more heated as the virus has spread globally. The CDC had said the purpose of its five-city surveillance program was to provide the U.S. with an "early warning signal" to help direct its response. The cities were selected based on the likelihood that infection would be present, Hamilton said.
But Mark Pandori, director of the Nevada State Public Health Laboratory, which began offering testing on Feb.11, said surveillance testing may not be the best use of resources right now. "A lot of people look at lab tests like they are magic," Pandori said. "But when you run lab tests, the more chances you have for getting false answers."
There are other ways to expand the country's testing capacity. Beyond the CDC and state labs, hospitals are also able to develop their own tests for diseases like COVID-19 and internally validate their effectiveness, with some oversight from the federal Centers for Medicare and Medicaid Services. But because the CDC declared the virus a public health emergency, it triggered a set of federal rules that raises the bar for all tests, including those devised by local hospitals.
So now, hospitals must validate their tests with the FDA — even if they copied the CDC protocol exactly. Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities.
Alexander Greninger, an assistant professor in laboratory medicine at the University of Washington Medical Center, said after he submitted his COVID-19 test, which copies the CDC protocol, to the FDA, a reviewer asked him to prove that his test would not show a positive result for someone infected with the SARS coronavirus or the MERS coronavirus — an almost ridiculous challenge. The SARS virus, which appeared in November 2002, affected 26 countries, disappeared in mid-2003 and hasn't been seen since. The MERS coronavirus primarily affects the Middle East, and the only two cases that have been recorded in the U.S., in 2014, were both imported.
There are labs that can create parts of a SARS virus, but the FDA's recommended supplier of such materials said it would need one to two months to provide a sample, Greninger said. He spent two days on the phone making dozens of calls, scrambling to find a lab that would provide what he needed.
Greninger said the FDA was treating labs as if they were trying to make a commercially distributed product. "I think it makes sense to have this regulation,'' he said, when "you're going to sell 100,000 widgets across the U.S. That's not who we are."
Commercial manufacturers are working to mass-produce coronavirus tests, but there isn't a precise timeline for their release. The drug company Cepheid, based in California, is targeting the second quarter of this year for the release of its test, a company spokeswoman said in an email. Massachusetts-based Hologic didn't have an estimated release date for its test, a company spokesman said. "We're responding to the public health need as rapidly as possible," the spokesman said.
Correction, Feb. 28, 2020: This story originally misstated the number of positive COVID-19 cases found via surveillance testing in the Chinese province of Guangdong. The testing found 420 positive cases, not 1,000.
The bipartisan proposal comes in response to a ProPublica story that showed how a personal trainer posed as a doctor to defraud prominent health insurers.
This article was first published on Friday, February 14, 2020 inProPublica.
Four United States senators have introduced a bipartisan bill to close a little-known, but gaping, loophole that allows scammers to plunder commercial insurers by posing as licensed medical providers.
The Medical License Verification Act, introduced Thursday, comes in response to a July ProPublica story that showed how absurdly easy it is to commit health care fraud, which experts say could be costing Americans hundreds of billions of dollars a year. ProPublica told the story of David Williams, a Texas personal trainer and convicted felon, who represented himself as a licensed physician when he applied for National Provider Identifiers, the unique numbers required by the federal government to bill insurance plans.
The Centers for Medicare and Medicaid Services administers the NPI program. But ProPublica found that it did not verify whether applicants had valid medical licenses, which could be done easily by checking with state licensing boards. That missing step allowed Williams to collect at least 20 different NPI numbers and bill some of the nation's most prominent health insurers, Aetna, Cigna and UnitedHealthcare, for millions of dollars in bogus medical services.
The insurance companies auto-paid the claims without checking to see if Williams had a license. Over more than four years, Williams filed more than $25 million in false claims with the companies, reaping more than $4 million. Some insurers actually sent him letters noting he wasn't a doctor and was filing false claims, but they continued to pay new claims anyway. In 2018, a jury convicted him of health care fraud and he's now in federal prison.
At his trial, investigators for the insurers said that their companies assume people are being honest when they file claims. The insurers told ProPublica it wasn't easy to stop the fraud because Williams billed them using different organization names and tax identification numbers.
The proposed Medical License Verification Act would require Medicare to verify that an NPI applicant's license is valid and in good standing before approving an NPI number. Sen. Rick Scott, R-Fla., called it a "commonsense step" in a statement released by the legislators. Consumers pay for fraud losses, Scott said, so the proposal will "prevent bad actors from defrauding families."
Cracking down on unlicensed providers will prevent fraud and lower health care costs across the board, Sen. Chris Van Hollen, D-Md., said in the statement. The bill was also signed by Sen. John Cornyn, R-Texas, and Sen. Catherine Cortez Masto, D-Nev. The bill's next step is to be assigned to a committee, where it will be considered, according to Scott's spokeswoman.
A Medicare official said the agency does not comment on proposed legislation. The trade group America's Health Insurance Plans, better known as AHIP, did not reply to a request for comment about the proposed legislation.
In the Williams case, the insurers and regulators were slow to stop the personal trainer's fraud even though his ex-wife and her father, Jim Pratte, had been reporting the criminal activity to them. Pratte said Thursday that he was pleased to hear about lawmakers' proposal to block scammers like Williams from easily getting NPI numbers. Politicians have talked for years about how to pay for the high cost of health care, Pratte said. "One major thing you can do without hurting anybody is cut out the fraud," he said.
The failure of insurers to take prompt action against Williams, and the ease of his fraud, led ProPublica to look at how aggressively such scams are pursued. Across the country, ProPublica foundthat insurance carriers not only made it easy for fraud to happen, they seldom pursued the fraudsters or referred them for prosecution.
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A government investigation found that the New Jersey hospital's transplant team was failing to learn from surgical errors.
This article was first published on Tuesday, January 21, 2020 in ProPublica.
Newark Beth Israel Medical Center's heart and lung transplant program was putting patients in "immediate jeopardy" before the hospital began to implement corrective measures, according to federal regulators.
In a pair of reports sent to the Newark, New Jersey, hospital on Dec. 12, the Centers for Medicare and Medicaid Services found that the transplant program repeatedly failed to fix mistakes. Spurred by ProPublica articles, the CMS investigation uncovered a series of incidents in which the hospital identified areas for improvement following botched surgeries but didn't carry out its own recommendations, allowing "subsequent adverse events to occur."
As a result, CMS determined that patients were in "immediate jeopardy," which is the regulator's most serious level of violation. It is invoked when "noncompliance has placed the health and safety" of patients "at risk for serious injury, serious harm, serious impairment or death."
Newark Beth Israel spokeswoman Linda Kamateh said in a statement that the hospital does not agree with all of CMS' findings, and that they did not warrant the "immediate jeopardy" designation. It will send a letter identifying "certain objections" to CMS, she said.
In particular, Kamateh criticized findings that attributed adverse events to "compliance failures in the transplant program." CMS' survey team, she said, lacks the "evidence, expertise and experience" to assess and diagnose patient outcomes. "Root cause analysis is a complicated exercise requiring much more extensive training, and much greater analysis than is reflected" in the CMS reports, she said.
On Dec. 15, three days after the hospital received the findings, it submitted a plan to remove the "immediate jeopardy" label by making certain policy changes, Kamateh said. The New Jersey Department of Health, which works in coordination with federal regulators, determined that those measures were enough to lift the designation, according to the hospital and CMS.
CMS also required the hospital to submit plans of correction, which are "under various stages of review and implementation," Kamateh said. As part of the plans, which the hospital sharedwith ProPublica, Newark Beth Israel has created a transplant steering committee to oversee the transplant program. Staff responsible for quality review in the transplant program will report directly to hospital management and not to the program's leaders.
Nevertheless, the hospital remains out of compliance with federal rules for quality assessment and performance improvement, surgical services, and patient rights, as well as special requirements for transplant centers, according to a CMS letter to the hospital on Jan. 12. In the letter, CMS warned Newark Beth Israel that, unless the issues are resolved by March 21, it will take steps to terminate the hospital from the Medicare program, which means the federal insurer would end reimbursements for Medicare patients. Medicare primarily insures people who are 65 or older.
CMS' December reports also cited violations of patient rights, including failures to obtain informed consent and to seek information from patients and family members on advance directives such as do not resuscitate orders. Although the reports do not identify patients or doctors by name, surgery dates and other specifics indicate that at least two of the cases were those brought to light by ProPublica articles last year.
CMS' findings may help to explain why the heart transplant program's one-year survival rate fell to 84.2% in 2018, well below the national average. The concern for statistics prompted the transplant team to keep Darryl Young, a patient in a vegetative state, alive without offering palliative options such as hospice care to the family, ProPublica reported last October.
Besides CMS and the New Jersey Department of Health, the FBI and New Jersey's Board of Medical Examiners are also investigating the hospital in the wake of ProPublica's reporting. Newark Beth Israel has placed Dr. Mark Zucker, the head of the transplant program, on administrative leave while it conducts an internal investigation.
Darryl Young suffered brain damage during a heart transplant at Newark Beth Israel and never woke up. But, hardly consulting his family, doctors kept him alive for a year to avoid federal scrutiny.
Legislators are seeking answers as well. On Jan. 14, citing ProPublica's "concerning reports," three members of New Jersey's congressional delegation asked CMS how it planned to hold Newark Beth Israel "and other programs that may engage in similar behavior" responsible and improve oversight "to ensure that this does not happen in New Jersey or any other state," according to aletter obtained by ProPublica.
"This lack of transparency, compassion, and communication" in the cases exposed by ProPublica "was cruel," wrote U.S. Sen. Robert Menendez, and U.S. Reps. Bill Pascrell Jr. and Donald M. Payne Jr., adding, "Both cases show a serious breach of the trust we place in health care providers and a clear violation of the Hippocratic Oath." CMS is working on a response, according to a spokeswoman.
The CMS reports focused mainly on Newark Beth Israel's heart and lung transplant programs, though one case involved patient safety in a psychiatric unit. Newark's heart program is one of the 20 largest in the country by volume, having transplanted more than 1,000 patients over the last three decades. Its lung transplant program is smaller.
Three patients suffered brain damage within a seven month span, apparently due to similar causes, according to the reports. In March 2018, a patient suffereda "neurological deficit" after a heart transplant operation. The hospital's own outcome report recommended a review of its blood pressure monitoring equipment, but CMS couldn't find evidence that any review took place. Less than a month later, another heart transplant patient suffered a "severe neurological deficit" during surgery. The outcome report gave the same recommendation. Again, CMS found no review occurred.
Then in September 2018, Darryl Young suffered brain damage during his heart transplant and never woke up again, ProPublica reported last year. CMS found that an unnamed patient — whose surgery date matches Young's — had a heart transplant resulting in "altered mental status." The hospital's outcome report recommended more frequent blood pressure monitoring, but CMS said it was unable to find evidence that staff were educated or that the change was implemented.
Before and after Young's surgery, in August and October 2018, a heart transplant patient and a lung transplant patient suffered complications during their operations that resulted in kidney failure. After the first incident, the hospital recommended increasing the frequency of blood pressure readings. In the second incident, the hospital report said the complication was "likely due to hypotension" — low blood pressure — in the operating room, and recommended monitoring for future occurrences. CMS said it could not find evidence that the recommendations were implemented.
Other improvement suggestions were also ignored. In January 2018, after a heart transplant patient died after surgery, the hospital's outcome report recommended having "a 2nd surgeon available for difficult and prolonged cases." The following May, after a complication occurred in another heart transplant operation, a similar note called for a "plan to encourage transplant physicians to ask and offer assistance for difficult and lengthy cases." However, CMS said it found no evidence that Newark Beth Israel educated its physicians to do so.
ECMO machines, which temporarily replace a patient's heart and lung function by pumping and oxygenating blood outside the body, malfunctioned during a lung transplant in December 2018, CMS found. The patient wasn't harmed, but the hospital noted it was a "near miss event" and recommendedusing what is known as a primed cardiopulmonary bypass machine in the event of problems with ECMO machines. "Perfusionists will be informed," the note said. However, CMS said it found no evidence that perfusionists — who operate bypass machines — were told. Then, the following February and April, ECMO equipment issues led to two other mishaps during lung transplant surgeries. The first patient ended up with a "neurological compromise," CMS found, and the second died in the operating room.
As part of its plans of correction, Newark Beth Israel said it has implemented a policy that makes sure backup equipment is available for any transplant procedure that involves an ECMO. It has has educated all perfusion and anesthesia staff, it said. It is also planning to review and monitor its blood pressure equipment, with the anesthesia department observing all transplant cases to make sure the equipment is properly placed "until 100% compliance has been achieved for three consecutive months."
In total, CMS detailed 10 "adverse events" from January 2018 to April 2019. As ProPublica reported last year, the heart transplant team became worried that its slipping survival rates — specifically, the proportion of patients who reached the one-year anniversary of their surgeries — would attract federal scrutiny. Zucker said at a staff meeting in May 2019 that Darryl Young "unfortunately became the seventh potential death in a very bad year, all right, and that puts us into a very difficult spot," according to an audio recording of the meeting obtained by ProPublica. Treating Young aggressively without offering other options to the family, Zucker said, "is a very, very unethical, immoral but unfortunately very practical solution, because the reality here is that you haven't saved anybody if your program gets shut down."
Young's sister and health proxy, Andrea Young, had told ProPublica that she felt doctors at Newark Beth Israel were "hiding something" from her, that her brother's prognosis wasn't fully explained to her and that she wasn't asked about her goals for his care until 10 months after his transplant surgery.
CMS' report corroborated this lack of candor. In the case of an unnamed patient, whose details, including transplant date and hospital admission date, matched Young's, the federal inspectors found that physicians wrote information including "prognosis is not great" in medical records in March and "overall prognosis is poor" in June. But CMS found no evidence that the patient's next of kin was given this information.
CMS located a social worker's note that Andrea Young had requested weekly updates on her brother's condition. The medical record "lacked documented evidence that the physicians contacted … next-of-kin on a regular basis, or a weekly basis as requested, regarding the progress of the patient," CMS said.
The hospital "is developing and will implement a standard for communications with patients and their authorized representatives," according to its plans of correction. Its spokeswoman, Kamateh, said medical records show that doctors and staff communicated repeatedly with Young's family and that family members "were contemporaneously informed of his status, his expected clinical trajectory, and his treatment options."
Told of CMS' findings in her brother's case, Andrea Young said in a statement: "It is my hope that NBI's Transplant Unit will implement the appropriate corrective measures to address the many existing deficiencies that plague their transplant program. Trust is especially paramount in the medical profession and restoration of that trust is essential to every patient and every family."
ProPublica reported in December on Andrey Jurtschenko, a heart transplant recipient at Newark Beth Israel who suffered brain damage during his operation. In earlier conversations, Jurtschenko had made clear to his children, Chris and Megan, that he didn't want to be a burden on them. The children told ProPublica that, when they sought a DNR order for their father after his surgery, they were initially rebuffed. The family continued to press the issue and secured a DNR more than a month after his surgery.
Again, the CMS investigation bore out the family's concerns, though it focused on a later incident when Jurtschenko was readmitted to the hospital from a rehabilitation facility. Describing a patient whose details — including transplant surgery and other procedure dates, as well as quotes from medical records — matched Jurtschenko's, CMS found that Newark Beth Israel violated its own policy on advance directives. The hospital's policy states that "an inquiry will be made of each adult patient, at the time of admission … concerning the existence and location of an Advance Directive for Health Care. If the patient is incapable of responding to this inquiry, the medical center will ask the family or person with knowledge of the patient." Yet, when the hospital admitted Jurtschenko, it marked "NO" in his paperwork to the question of whether he had an advance directive, even though his children, who were his health proxies, would have requested a DNR order if it had consulted them.
Kamateh said that families "make these very personal decisions following a dialogue with the clinical team taking into consideration the best medical advice," adding, "Mr. Jurtschenko's medical record confirms that his family's decision to implement a DNR in June rather in April did not change his outcome."
CMS alsofound that Newark Beth Israel "failed to ensure a patient's right to have a family member notified of his/her admission to the hospital" because it had admitted Jurtschenko to the hospital from the rehabilitation facility without informing family members.
The hospital will train staff in obtaining information about advance directives, health care proxies, and surrogate decision-makers, according to the correction plans.
Andy Jurtschenko told his children that he didn't want to be a burden on them. But after he suffered brain damage during a heart transplant at a New Jersey hospital, his medical team deflected their request for a DNR.
In a reference to ProPublica's reporting, CMSfound that hospital staff members violated patients' rights by sharing patients' information with a journalist "for purposes other than treatment, payment and health care operation." It noted that Newark Beth Israel had an internal compliance hotline and ethics consultation team, which did not receive any complaints or reports of concerns regarding transplant patients.
Unrelated to the transplant program, CMS also found that a 14-year-old patient was left unsupervised in October 2019 in the presence of an adult patient "with a history of aggressive, violent and erratic behavior," accordingto the report. The minor, who wanted to use the bathroom, was brought there by a staff member and left there. Afterward, she told the staff that "a patient walked into the bathroom and kissed" her. The incident violated a patient's right to receive care in a safe setting, CMS said.
Immediately after the incident, Newark Beth Israel interviewed the patient and notified the parent, the Newark Police Department and the New Jersey Division of Mental Health Addiction Services, according to the hospital. According to its correction plans, the hospital has adopted a new policy to minimize contact between minor and adult patients in its psychiatric emergency screening services unit. "Policies around the monitoring of minor patients were immediately strengthened," Kamateh said.
Andy Jurtschenko told his children that he didn't want to be a burden on them. But after he suffered brain damage during a heart transplant at a New Jersey hospital, his medical team deflected their request for a DNR.
This article was first published on Tuesday, December 31, 2019 in MedPage Today.
Three weeks after his heart transplant, Andrey Jurtschenko still had not woken up.
A towering figure at 6 feet, 3 inches, with salt-and-pepper hair and matching mustache, Jurtschenko — known to one and all as Andy — delighted friends and family with his seemingly endless supply of wisecracks and goofball humor. On April 5, 2018, he went into surgery at Newark Beth Israel Medical Center in Newark, New Jersey, for a new heart and what he hoped would be renewed energy. He dreamed of returning to his carpet business and to enjoying New York Mets games on the weekends after years of exhaustion and strain caused by congestive heart failure.
Typically, patients begin reviving within 24 hours after transplant surgery. Andy didn't. As the days passed, his children, Chris and Megan Jurtschenko, became increasingly concerned. On April 26, a neurologist called Chris and explained what an MRI the day before had shown: Andy's brain had likely been deprived of oxygen during the procedure. The doctor said he "would basically be in a vegetative state," Chris recalled in an interview. Chris asked to meet with the medical team the next day.
The devastated family took some comfort in knowing what Andy would have wanted. In several conversations before the surgery, he had made clear that "he did not want to be a burden on us, he did not want to live in an incapacitated form," Andy's older sister, Anna DeMarinis, said.
Now that their father could not speak for himself, Chris and Megan, as Andy's next of kin, had to be his voice. On April 27, they went to the hospital for the meeting. Still hoping Andy might recover, they did not seek to withdraw his feeding tube or medications. But they asked for a do not resuscitate order. If he were to stop breathing or have no pulse, a DNR order would direct doctors not to compress his chest, use a machine to force air into his lungs or give electric shocks to restart his heart.
If his heart stopped, "we weren't going to force him to stay," Megan said.
Dr. Margarita Camacho, the surgeon who had performed the transplant, deflected their request, the siblings said. She told them that it was too early for a DNR, and that they shouldn't give up hope because their father might recover, his children said. At Camacho's urging, Megan and Chris said, they let it go. No DNR order was signed that day. The family would continue to press the issue and finally secure a DNR more than a month later.
Megan and Chris Jurtschenko waived their privacy rights to allow the hospital to discuss their father's case with ProPublica. Asked directly about the meeting with the surgeon and why the family's wishes were not followed at the time, Linda Kamateh, a spokeswoman for Newark Beth Israel and Camacho said in an email: "Physicians are obliged to give their best medical advice based on a patient's medical condition. However, ultimately the decision to have a DNR resides with the patient. The hospital believes that it adhered to those principles in its discussions with the Jurtschenko family."
Except for "a very specific set of dire medical circumstances, in which a patient may require resuscitation," a DNR "does not otherwise affect ongoing care and treatment," Kamateh wrote in a separate email. "... These decisions are often revisited and reassessed within the course of treatment."
Andy's medical record doesn't mention the children's request for a DNR. "The family was able to express their concerns and decided to continue to see how PT [patient] progresses over the next few weeks," a social worker wrote.
Bearing out Camacho's prognosis, Andy would awaken and recover some cognitive ability — but only enough to attain the incapacitated state he had dreaded, not to become again the man that his children knew and loved. They remained adamant that, if his heart stopped, he would have preferred to die than to be resuscitated for such an existence.
The American Medical Association's code of medical ethics states, "The ethical obligation to respect patient autonomy and self-determination requires that the physician respect decisions to refuse care." Yet Newark Beth Israel's transplant team was often reluctant to sign DNR orders, according to four former employees and an audio recording of a staff meeting. While the team wouldn't outright refuse, especially when patients or their family members repeatedly asked, it often delayed or discouraged DNRs, especially before key dates tied to performance metrics such as the one-year survival rate, or the proportion of people undergoing transplants who are still alive a year after their operations, three of the ex-employees said.
The team also lacked a process for discussing beforehand whether patients would want CPR if their pulse or breathing stopped after their operations, the former employees said. Typically, the staff addressed the issue only if a patient's condition became critical and family members were insisting on a DNR.
Newark Beth Israel's DNR policies are consistent with best practices, Kamateh said. "These policies guide our clinical teams in support of the treatment decisions of our patients and their families, from the most routine procedures to the most complex and stressful situations," she said. "We strive to explain care options and deliver sound medical advice in ways that are timely and clear, yet also respectful and sensitive."
At least indirectly, the concern about DNRs may have stemmed from Newark Beth Israel's aggressive approach to transplants. Newark Beth Israel's heart transplant program is one of the top 20 in the U.S. by volume, having grown under Dr. Mark Zucker, its director for three decades, and Camacho, the main surgeon. As of November, the hospital had performed 1,096 heart transplants.
The program is known for taking on sicker patients who might be rejected at other programs. From 2014 through 2017, compared with its counterparts in New Jersey and nearby states, Newark Beth Israel's transplant team operated on a higher percentage of patients who were older, more overweight or obese, and who had been in an intensive care unit while awaiting transplant, according to the Scientific Registry of Transplant Recipients. (The registry is funded by the U.S. Department of Health and Human Services to track and analyze transplant outcomes.) In those years, Newark Beth Israel also had a higher percentage of patients who had been on a pump or some other support before transplant, which increases the difficulty of surgery. This stance filled an important gap in care and helped the program grow both in size and revenue; hospitals typically bill insurers about$1.4 million for a heart transplant.
"While the Advanced Heart Failure Treatment and Transplant Program at NBI does not seek out cases that are more complex than those handled by other prestigious transplant programs, patients from other programs have been referred to our care and been successfully transplanted," Kamateh said. "Our clinical decisions are driven by the best interest of our patients, including their personal preferences, not by statistical results."
Scores of grateful patients say they owe their lives to Zucker and Camacho.
"Dr. Zucker has saved my life again and again," said Mark Reagan, a retired AIG executive in Bluffton, South Carolina. Reagan received his heart transplant at Newark Beth Israel in March 2003 after suffering from congestive heart failure for eight years. Reagan said his arteries were initially too narrow for a transplant, but Zucker opened his arteries with an experimental treatment so he could get onto the waitlist. After his surgery, Reagan became part of the "Hearty Hearts" volunteers at the hospital who advocate for organ donations and lift the spirits of other transplant recipients. Through "Hearty Hearts," he said, he has met several transplant candidates who were turned away by other hospitals but "walked out of Newark Beth Israel with a new heart, because of Mark."
Accepting more difficult cases, though, can raise the risk of adverse outcomes. According to former employees and audio recordings of staff meetings, Newark Beth Israel's transplant team worried about its one-year survival rate, which would drop below the national average in 2019. That anxiety, the employees said, appeared to underlie the team's unwillingness to sign DNR orders, since resuscitation might be needed to keep a patient alive.
Besides Andy Jurtschenko's children, two former NBI employees, including one with firsthand knowledge, said that the transplant team initially balked at a DNR order for him. By ruling out extreme measures to revive him, a DNR could conceivably have hastened Andy's death and lowered the program's one-year survival rate. Whether or how much metrics influenced Camacho's rebuff of the DNR request is unclear. While DNR orders are documented in the medical record, unapproved requests — and the reasons behind those decisions — generally aren't.
There can be few greater points of contention between physicians and families, few so infused with emotion and anguish on both sides, than whether to resuscitate someone on the verge of death. Hospitals have been suedand nursing homes finedfor resuscitating patients who had a DNR order on file. Or families may urge a medical team to initiate resuscitation that a physician believes is futile, or even torture, for a patient with a terminal diagnosis. The decision is inherently subjective, and ultimately, doctors are supposed to respect the wishes of patients — or, if they can't speak for themselves, their health care proxy.
A heart transplant itself is an act of resuscitation; there is a moment, after the old heart has been removed and the new organ not yet implanted, when the patient is only kept alive by a machine. If a surgery goes badly and a patient suffers serious complications, a request for a DNR can become a flashpoint, revealing the pressures that transplant teams are under to save patients, make sure that scarce donated organs don't go to waste and meet performance metrics.
More so than almost any other field of medicine, organ transplantation in the United States is tightly regulated. The U.S. Centers for Medicare and Medicaid Services can halt reimbursement if they find a program falling short of their standards. Transplant programs in the U.S. are constantly aware of the importance of keeping their survival rates at or above national medians, said a heart transplant surgeon at another hospital in the Northeast. "We are only judged on the numbers, on the results," said the surgeon, who requested anonymity to avoid jeopardizing future job opportunities. "My main job is to treat percentages, not patients."
In that context, medical staff can be reluctant to relinquish the option of resuscitation. "The 365-day problem is real, and if you gave truth serum to every transplant doctor in America, including me, and you asked if we didn't all keep an eye on it, and if we said we didn't, that would be a lie," said Dr. David Weill, a consultant to transplant programs and former director of the heart-lung transplant program at Stanford University Medical Center. As the one-year anniversary approaches, Weill added, he's seen doctors tell patients, "'It's too early [for a DNR], I've seen people recover, she has a strong will to live,' these kind of things."
Such attitudes extend beyond transplant wards to other types of cardiovascular surgery that judge success by survival metrics, though their key target is typically 30 days, not a year. An acute care nurse practitioner with more than two decades of experience in open-heart surgery care told ProPublica she's worked in several cardiac wards where families were discouraged from withdrawing life support or asking for a DNR before 30 days had elapsed.
"Families are lied to, they'll be told, 'It's too soon,' then after 30 days, doctors will say, 'Make them a DNR, go ahead,'" said the nurse, who requested anonymity because she feared retaliation from her employer. (She hasn't worked at Newark Beth Israel.) "Unless you have a medical directive and, if you're unable to speak for yourself, a relative with power of attorney, the hospital's driving the bus."
Metrics aren't the only reason that surgeons balk at DNR requests. They are trained to do everything they can to save lives. When a patient dies, while other doctors might blame a treatment protocol or the deceased's lifestyle, surgeons often feel personally responsible, according to Dr. Gretchen Schwarze, associate professor of vascular surgery at the University of Wisconsin School of Medicine and Public Health. In a 2010 study, Schwarze posed hypothetical scenarios to 10 surgeons, including a transplant specialist. One scenario described a patient who remained intubated and on a feeding tube a week after surgery. A family member then produces a previously undisclosed directive from the patient, asking not to be sustained by life support.
The surgeons "expressed significant emotional reaction," including "betrayal, unhappiness, disappointment," Schwarze reported. They felt that there was an implicit contract that patients entered into when signing up for surgery. One surgeon put it this way: "There is a commitment made by both the patient and the surgeon to get through the operation, as well as all of the post-operative issues that come up." While acknowledging that they were being "paternalistic" and contradicting the patient's directives, several of the surgeons in the study said they would refuse to withdraw life support in Schwarze's scenario.
One reason for conflicts over DNRs is that most patients aren't asked ahead of time about their desires for post-operative care. A 2010 study of admissions at two U.S. hospitals found that only one-third of seriously ill patients were asked what code status they wanted if they went into cardiac or respiratory arrest, and those conversations on average lasted one minute.
"We tend to wait too long to have a meaningful conversation. We wait until someone's been in the ICU for a while, until the point that the patient cannot participate in the conversation," said Luke Adams, a critical care nurse in Pennsylvania who founded a company called Advanced Care Solutions, which helps people write advance directives and navigate end-of-life decisions.
During a heart transplant operation, a patient cannot have a DNR order in place. The new heart may need to be shocked or stimulated with chest compressions to help it function properly. These actions would be considered "resuscitation."
After surgery, however, a patient should be able to ask for a DNR order at any time, and in the case of patients who can't speak for themselves, the request can come from a surrogate, usually the closest relative. A DNR order must be signed by a physician and put in the medical record. In New Jersey, DNR orders are typically entered as part of a form called a POLST, short for Practitioner Orders for Life-Sustaining Treatment, which also includes sections for other medical directives, including whether to use artificial nutrition and antibiotics.
Resuscitation is no assurance of either immediate or long-term improvement. A 2003 study of in-hospital resuscitation tracked 14,720 cardiac arrests and found that 44% of patients regained circulation, but only 17% recovered enough to be discharged from the hospital.
Darryl Young suffered brain damage during a heart transplant at Newark Beth Israel and never woke up. But, hardly consulting his family, doctors kept him alive for a year to avoid federal scrutiny.
Sometimes a DNR order is the obvious choice, said Dr. Perla Macip-Rodriguez, assistant professor of internal medicine at the Boston University School of Medicine, who specializes in palliative care and geriatrics. She gave the example of a patient with late-stage cancer that is no longer treatable. If the patient's heart stopped, CPR would not affect the terminal diagnosis. "It's just going to prolong their dying process."
Other cases are murkier. Andy Jurtschenko's brain was severely damaged. If his heart stopped and he was resuscitated, nobody could know what the outcome would be.
When the prognosis is uncertain, the medical team should focus on the patient's individual goals, said Dr. Jessica Zitter, an internist at Highland Hospital in Oakland, California, who practices both critical care and palliative care. "We should never, ever force treatment on a patient or their surrogate," she said. "There's no way you can ever insist on someone remaining on a machine or being resuscitated so long as the family has the patient's best interest in mind. That's called autonomy."
Megan Jurtschenko's fondest childhood memories involve visiting her father's carpet store, climbing on the stacks of samples and running her fingers over soft rugs while listening to him bantering and laughing with his clients.
The U.S.-born son of Eastern European immigrants, Andy Jurtschenko worked his way up through local furniture chains until he was able to open his own store, Route 46 Carpet, in West Paterson, New Jersey. His gift for patter made him a natural salesman. Divorced, he stayed close to his children. On his Facebook page, he described himself as "a caring American."
But in 2012, Andy began to feel tired and short of breath. Doctors diagnosed him with congestive heart failure. By 2014, as his heart became weaker, Andy had to stop working and go on disability. He was 57 years old. It frustrated him to rely on the government for financial support.
"All he ever wanted was to care for himself and his family. Losing that was not easy for him," Megan said.
Megan and Chris knew Andy would not want to be kept alive by extraordinary means. Just surviving wasn't his goal. His children wanted his caregivers to understand this as well.
On May 21, Andy was transferred from Newark Beth Israel to a rehab facility, JFK Johnson Rehabilitation Institute. Within a few days, a staff member of the facility called, asking for medical directives.
"They described him as very high risk for code, and they wanted to establish what we wanted," Megan recalled. If his heart were to stop, she instructed them, "they would not do any chest compressions, no electric shock. And if his lungs stopped functioning they would not put in a breathing tube. We wanted no artificial care."
Chris noted the difference between the rehab facility and the hospital. JFK "came to us and said we need to put this in place, where Newark kind of avoided it," he said.
Hackensack Meridian Health, a New Jersey network that includes JFK Johnson, "has comprehensive DNR policies that we consider an essential part of providing high-quality patient care," spokeswoman Mary Jo Layton said in an email. "Our teams work collaboratively with patients, their families and loved ones to ensure our patients' wishes are honored."
In September 2018, five months after Andy's surgery, another Newark Beth Israel patient, Darryl Young, suffered brain damage during a heart transplant. As ProPublica has reported, Zucker instructed his staff to keep Young alive and not to discuss palliative care options, such as hospice, with his family until the one-year anniversary of his surgery.
If Young were to die, the hospital's annual one-year survival rate, already at its lowest in a decade, would drop even further. In a previously unreported audio recording obtained by ProPublica, Zucker told his staff at a meeting in April 2019, "You can send him back to a rehab facility, but if you make him DNR at the rehab facility — they will make him DNR — it'll be a problem for us."
Zucker continued, "So, I don't really know what to do except to tell you that I recognize what I'm asking, I said myself I'm not sure that this is ethical, moral or right, but for the global good of the future transplant recipients, the others who come along, this program can't be put into an SIA."
SIA stands for systems improvement agreement, a process through which CMS can force a transplant program to get back into compliance. It typically costs a hospital at least $2 million. After the April meeting, Zucker's team never released Young to a rehab center, and he remains at the hospital. Young's sister, Andrea, did not request a DNR, and the team only discussed the option with her after ProPublica's article was published, she said.
The Centers for Medicare and Medicaid Services, the FBI, the New Jersey Department of Health and the State Board of Medical Examiners are investigating the hospital's treatment of Young. The hospital has placed Zucker on leave pending the results of its own review.
Newark Beth Israel and Zucker did not respond to questions about his comments regarding a DNR for Young.
On June 1, 2018, Megan Jurtschenko went to visit her father at the rehab facility, but his room was empty. After being transported to Newark Beth Israel the previous day for a checkup, he hadn't returned to JFK Johnson.
Panicked, Megan grabbed an Uber to the hospital. There, she raced to the fourth floor, sneakers pounding against the floor as she beelined for the cardiology unit. By that point, Andy had regained consciousness and could sometimes nod yes or no, but he easily became agitated, according to his children. Andy's medical record from that day described him as "non-verbal."
Megan went to her father's room first "to let him know that he wasn't alone" and then to the nurse's station, where two physicians met her. She said they told her that her father had a fever when he arrived for his checkup, so they kept him overnight and started a course of antibiotics. The hospital suspected pneumonia, according to his medical record.
Nobody at the hospital had called Megan, Chris or anyone else in the family to let them know that Andy was being admitted or treated, his children said. A few days later, a handwritten note in Andy's medical record said that the family was "upset" that they weren't informed.
Megan said she turned to a nurse to ask, "What's his code status?"
"Oh don't worry, he is at full code," the nurse responded, meaning that if Andy stopped breathing or his heart stopped, they would do everything possible to resuscitate him.
Her words riveted Megan to the floor.
"I said, 'Oh, no, that is the complete opposite of what we want.'"
Newark Beth Israel didn't respond to questions about this incident.
Andy needed to stay in the hospital until his infection cleared. That Friday, Megan refused to leave the hospital until she got a DNR order, so a cardiologist signed one. "Extensive discussion with daughter — Patient is DNR," a note in the medical record states. The family scheduled a formal meeting to discuss the order on the following Monday with a palliative care nurse practitioner and Zucker, the transplant program's director.
Chris was out of town, so Megan and her aunt, Anna DeMarinis, attended the meeting. Megan reminded Zucker that her father's goals for the transplant had been to resume his normal life, she said. She reiterated that the family wasn't asking to withdraw his feeding tube or medications. They just didn't want Andy to endure what they saw as extraordinary measures.
As Camacho had, Zucker urged caution. "He looked at me and said: 'You know, this is a very serious document. It's very extreme. Are you sure you want to do this?'" Megan recalled.
She wondered if Zucker was appealing to her emotions. "I got the impression he thought I was going to be the one who was going to say, 'No, I don't want to lose my Dad, let's keep trying!'"
Megan wasn't swayed. "I could see what was actually happening, which is — he was suffering and that's the only thing I saw." The palliative care nurse at the meeting revised and signed Andy's POLST form, indicating that Andy would continue full medical treatment unless he stopped breathing or had no pulse. In the CPR section, she checked the box for "Do not attempt resuscitation."
Even then, Zucker wouldn't let it go. After returning from his trip, Chris was sitting by his father's bedside when Zucker came by. Unprompted, Zucker brought up the DNR.
"He said, 'So, you're giving up on him.'" Chris recalled.
Chris didn't respond. "I was shocked, for a doctor to throw that in my face," he said.
Newark Beth Israel and Zucker did not respond to questions about the meeting with Megan or Zucker's conversation with Chris. "Mr. Jurtschenko's medical record confirms that his family's decision to implement a DNR in June rather than in April did not change his outcome," Kamateh said.
Andy Jurtschenko eventually returned to JFK Johnson. Over the next few months, during which he was moved to a different long-term care facility, Andy's condition improved modestly, until he was able to track people with his eyes and have short conversations.
But his gains soon plateaued. He was never able to stand, sit or eat on his own. He started hallucinating, seeing people who weren't there. Over time, his hands began to atrophy and curl in on themselves, despite attempts at physical therapy.
Andy's family members took turns visiting, making sure he had company nearly every day. Sitting by his side, they tried to engage him by flipping through photo albums, playing music from his favorite band, AC/DC, and watching sports on TV. They ached to see his misery. The spark in her younger brother's eyes was gone, DeMarinis said. Holding back tears, she said, "When he did become cogent, he just kept reiterating what we already knew — he was suffering. He was suffering terribly."
On the morning of Oct. 31, 2018, the rehab facility phoned Chris. Andy had died at sunrise. When his heart stopped, and his breathing faded, there was no attempt to resuscitate him.
CMS terminated an agreement and federal funding for Chicago Lakeshore Hospital, and the Illinois Department of Public Health is moving forward with plans to revoke the facility's license.
The article was first published on Friday, December 27, 2019 in ProPublica.
After more than a year of lawsuits and government extensions, federal authorities this week ended their Medicare agreement with a Chicago psychiatric hospital plagued by allegations of abuse and safety violations. The Illinois Department of Public Health said Thursday it is moving forward with plans to revoke the hospital's license.
The Centers for Medicare and Medicaid Services terminated the agreement and accompanying federal funding for Chicago Lakeshore Hospital on Monday after seven inspections since July 2018 found deficiencies that threatened the health and safety of the patients, federal records show.
The federal government will continue payment for up to 30 days for patients admitted to the hospital in Chicago's Uptown neighborhood before midnight Monday, a federal spokesman said. Hospital officials said Monday that Lakeshore, formerly known as Aurora Chicago Lakeshore Hospital, will remain open as they work with authorities and examine their options.
Meanwhile, IDPH has taken steps with the Illinois Hospital Licensing Board to begin an administrative proceeding to "revoke Chicago Lakeshore's state license imminently," department spokesman Cris Martinez said Thursday.
"Chicago Lakeshore Hospital has demonstrated a continued failure to comply with regulations," Martinez said.
Gov. J.B. Pritzker's office said Thursday that IDPH worked with the hospital to take corrective action, but that the facility has not only failed to comply with regulations but also "jeopardized patient health and safety," Pritzker press secretary Jordan Abudayyeh said. The governor's office is working with state agencies to "ensure patients can receive the care they need without interruptions," she said.
Payments from Medicaid, a joint state and federal program, also were terminated. Lakeshore officials have previously said the hospital will be forced to close if its Medicare and Medicaid payments were ended. Last year, more than 80% of its patients were insured through one of the two programs, court records show. Those patients and hospital employees would suffer, Lakeshore officials have argued, as the facility is one of the largest behavioral health providers in the state, serving about 5,000 patients annually.
In anticipation of the termination of payments, officials began to halt Medicaid admissions to Lakeshore earlier this month. There are currently about 40 Medicaid patients there, who will be discharged or transferred, according to a spokesman for the Illinois Department of Human Services.
Last month, IDPH inspectors, acting on behalf of federal authorities, found that Lakeshore had failed to implement proper safety precautions after a suicidal patient notified a nurse she wanted to hurt herself, according to records. The patient was later found unresponsive with a sheet wrapped around her neck. The nursing staff was able to revive her, records show, and she was transferred to another hospital. Inspectors also cited the hospital for failing to monitor a patient who was known to sexually act out and who allegedly abused another patient.
Lakeshore officials said in their statement Monday that the hospital has a decadeslong history of providing critical mental health services to patients, especially those with "nowhere else to go."
"Quality patient care has always been a top priority for our dedicated staff," the statement read. "In light of all that has been taken out of context, distorted, or exaggerated, it has been difficult over the last year to give justice to the great care Chicago Lakeshore Hospital provides every day, every work shift to a population of patients who have been forgotten by so many before landing at our door."
Hospital officials said they will continue to provide services for their patients and work with state and federal authorities over the next month to safely transition all Medicare and Medicaid patients out of the facility.
A new lawsuit calls Chicago Lakeshore a "hospital of horrors," where children as young as 7 were allegedly sexually abused and others were injected with sedatives and physically attacked — all while officials covered it up.
ProPublica Illinois and the Chicago Tribune last year separately reported troubling conditions at the hospital, including allegations of sexual and physical abuse against children in the state's child welfare system. At the time, the Illinois Department of Children and Family Services relied heavily on the psychiatric hospital but, following the news reports and subsequent pressure from lawmakers and the American Civil Liberties Union of Illinois, the agency late last year stopped sending children in its care there.
Over the past 15 months, Lakeshore has filed multiple lawsuits and administrative appeals in an attempt to halt the Medicare termination initially set to take effect August 2018. U.S. District Judge Sharon Johnson Coleman last December approved the hospital's request to keep federal officials from immediately pulling funding, but Coleman vacated that order last week. She also denied the hospital's latest effort to avert the termination.
In her Dec. 19 ruling, Coleman wrote that federal officials have offered Lakeshore numerous opportunities to correct the deficiencies. Officials were not required to to give the hospital yet another opportunity, she wrote, "especially in light of (the hospital's) inability to provide a safer environment for its young patients."
Also last week, the Cook County public guardian filed a lawsuit that called Lakeshore a "hospital of horrors" where children as young as 7 had been abused.
In response to the Medicare termination, a spokeswoman for Blue Cross and Blue Shield of Illinois said the insurer had removed the hospital from its networks on Tuesday. In recent court filings, Lakeshore said Blue Cross was the hospital's third-largest source of revenue in 2018, at around 9%, after Medicaid and Medicare.
Lakeshore can file an administrative appeal with federal authorities, but the termination will remain in place during that time. Federal regulations also allow the hospital to reapply for its Medicare certification, but it must provide "reasonable assurance" that the cause for the termination no longer exists and will not recur.
Drug companies have paid doctors billions of dollars for consulting, promotional talks, meals and more. A new ProPublica analysis finds doctors who received payments linked to specific drugs prescribed more of those drugs.
This article first appeared on Friday, December 20, 2019 in ProPublica.
Doctors who receive money from drugmakers related to a specific drug prescribe that drug more heavily than doctors without such financial ties, a new ProPublica analysis found. The pattern is consistent for almost all of the most widely prescribed brand-name drugs in Medicare, including drugs that treat diabetes, asthma and more.
The financial interactions include payments for delivering promotional talks, consulting and receiving sponsored meals and travel.
The 50 drugs in our analysis include many popular and expensive ones. Thirty-eight of the drugs have yearly costs exceeding $1,000 per patient, and many topped the list that are most costly for the Medicare Part D drug program.
Take Linzess, a drug to treat irritable bowel syndrome and severe constipation. From 2014 to 2018, the drug's makers, Allergan and Ironwood, spent nearly $29 million on payments to doctors related to Linzess, mostly for meals and promotional speaking fees.
ProPublica's analysis found that doctors who received payments related to Linzess in 2016 wrote 45% more prescriptions for the drug, on average, than doctors who received no payments.
Those findings were repeated for drug after drug. In 2016, doctors who received payments related to Myrbetriq, which treats overactive bladder, wrote 64% more prescriptions for the drug than those who did not. For Restasis, used to treat chronic dry eye, doctors who received payments wrote 141% more prescriptions. The pattern holds true for 46 of the 50 drugs.
On average, across all drugs, providers who received payments specifically tied to a drug prescribed it 58% more than providers who did not receive payments.
Other research, including our own, has found a correlation between payments and overall prescribing. This new analysis expands upon past work by looking individually at a variety of popular drugs. "What clearly jumps out is how consistent the association is across drugs," said Aaron Mitchell, a medical oncologist at Memorial Sloan Kettering Cancer Center who has studied pharmaceutical payments for oncology drugs.
Our analysis looked at the relationship in two ways: whether those who received payments prescribed more of a drug, as well as whether those who prescribed a drug received higher payments than those who did not. We found that, on average, physicians who prescribed a drug received higher payments related to the drug that same year than those who didn't prescribe it. For Linzess, the value of payments was more than four times higher for providers who prescribed the drug than among those who did not. For Myrbetriq, it was three times higher, and for Restasis, it was twice as much. (Read our methodology for more about the analysis.)
Holly Campbell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, an industry trade group, said it stands to reason that doctors who have interactions with a company about a drug may prescribe more of it "because they have more information about the appropriate uses for the products."
Through spokespeople, Allergan (maker of Linzess as well as Alphagan P, Bystolic, Combigan, Lumigan, Namenda and Restasis), Janssen (maker of Invega, Invokana, Xarelto and Zytiga) and Novo Nordisk (maker of Levemir, Novolog and Victoza) described their interactions with physicians as important for sharing medical information.
Novo Nordisk added that prescribing data is not used to target physicians for speaking or other promotional interactions. Eli Lilly said in a statement that meals can take place in many contexts, including in doctors' offices, at speaker events and at conferences, but didn't answer other questions. GlaxoSmithKline, Ironwood, Astellas and Purdue declined to comment.
For some drugs that are household names, it was more common for prescribers to receive a payment than not to. More than half of doctors who prescribed Breo, an expensive asthma drug, to Medicare patients received payments involving the drug in 2016. This was also true for Invokana and Victoza, both of which are diabetes medications. For Linzess, nearly half of doctors who prescribed the drug had interactions with its maker.
More than one in five doctors who prescribed OxyContin under Medicare in 2016 had a promotional interaction with the drug's manufacturer, Purdue Pharma. The company did not respond to a request for comment.
"If there are physicians out there that deny that there is a relationship, they are starting to look more and more like climate deniers in the face of the growing evidence," said Aaron Kesselheim, a professor of medicine at Harvard Medical School and an expert in pharmaceutical costs and regulation. "The association is consistent across the different types of payments. It's also consistent across numerous drug specialties and drug types, across multiple different fields of medicine. And for small and large payments. It's a remarkably durable effect. No specialty is immune from this phenomenon."
Huey Nguyen, a gastroenterologist in southern Indiana, increased his prescribing of Linzess in recent years. From 2013 to 2015, Nguyen's Medicare patients had fewer than 60 claims per year for Linzess. In 2016 and 2017, that jumped to over 110 claims per year.
Over that time, Nguyen was a promotional speaker for Linzess. Allergan paid him $1,000 in 2013, over $4,000 in both 2016 and 2017, and $2,000 in 2018 to speak about the drug.
Though Linzess has been on the market since 2012, Ironwood and Allergan made a big push to promote the drug in 2016 and 2017. Spending on doctors reached $10 million in 2016 and nearly $8 million the following year, up from under $4 million in both 2014 and 2015.
In total, Nguyen has earned $25,000 from 2014 to 2018 related to six drugs from four pharmaceutical companies, excluding meals. In 2018, he was paid by two companies to promote competing drugs that treat irritable bowel syndrome.
ProPublica's analysis did not set out to examine, nor did it resolve, whether industry payments change doctors' behavior, or if patients receive inferior care from doctors who receive payments. Many factors can influence doctors' prescribing choices. Some patients, for instance, have conditions for which only brand-name treatments are available or for which other drugs have failed.
Nguyen said promotional speaking educates doctors about how a drug works, whether insurance covers it and when not to prescribe it.
"It's a way for the primary care physicians to have access to a gastroenterologist where they can ask one-on-one questions," Nguyen said. "I'm more educated towards the drug, because I have to be trained to speak on it, so I'm more comfortable prescribing it."
Experts are skeptical that interactions between companies and doctors benefit patients. "If there really were innovations and real benefits that were accruing to patients for a new treatment, it shouldn't take so much spending by the company to get the word out," said Stacie B. Dusetzina, associate professor of health policy at Vanderbilt University Medical Center, who advised ProPublica on the design of its analysis. "I wonder if promotion is really to try to push products that have a much less substantial benefit because they're not gaining the market share naturally."
Nguyen said he takes many things into account when prescribing a drug, including its approved uses, cost and side effects. "In my day-to-day practice, my patients still come first," Nguyen said. He said the speaking engagements do not influence his prescribing, "at least not consciously. Unconsciously, I don't know." He sees the public disclosure of industry payments to doctors as a way to help patients be active participants in their care.
Nguyen said he works with companies for the extra compensation but acknowledged that "it's perfectly reasonable for people to question my motives."
ProPublica's analysis matched doctors' prescribing in Medicare's prescription drug program to the industry payments doctors received. Drug and medical device companies are required to report these payments annually through the federal Open Payments program, and they are made public on a government website. More than 600,000 doctors receive payments annually. (Companies also report research payments and ownership interests, but these were excluded from our analysis.)
Some providers were paid thousands of dollars, often for promotional speaking. But the typical doctor took in much less. Most only received meals, typically worth less than $100 per year.
In 2016, ProPublica found a relationship between the total dollar value of a doctor's interactions with drug and device companies and the overall percentage of brand-name drugs he or she prescribed.
Brand-name drugs are more expensive than generic options, both for patients and for Medicare. A recent report from the Department of Health and Human Services found that Medicare Part D and its beneficiaries could have saved almost $3 billion by switching from brand-name drugs to generics.
Linzess is an expensive drug, costing Medicare and patients an average of about $1,500 annually. A common alternative is the laxative Miralax, available over the counter as generic polyethylene glycol, which costs less than $200 annually if taken every day. Nguyen said he recommends Miralax to many patients, but that wouldn't show up in Medicare's data because Medicare doesn't cover over-the-counter drugs. He said he often prescribes Linzess to patients who have tried Miralax and not seen the symptom relief they hoped for.
For brand-name drugs that have good generic alternatives, "every time a doctor prescribes one of these brand-name medications, it's extra money transferred from the Medicare program to the manufacturer," said Michael Barnett, assistant professor of health policy at Harvard T. H. Chan School of Public Health. "Medicare spending is out of control. And drug costs are one of the major reasons."
Drug cost can have major consequences, not just for Medicare balance sheets but also for patients' well-being. "The newest, latest drug is often not any better than the old drugs" that treat the same condition, Mitchell said. "But the new drugs are always more expensive. That really hurts patients' pocketbooks. You've got physicians prescribing more expensive drugs and patients who aren't taking them as a result. A generic medicine that's cheaper that a patient does take is a whole lot more effective than an on-brand, expensive medicine that they don't take.
Last year, the federal government promised to improve vetting of doctors who administer immigration medical exams. But ProPublica found doctors with records of unprofessional behavior, including sexual misconduct, drug abuse and fraud, still have the federal government's approval.
This article first appeared on Thursday, December 12, 2019 in ProPublica.
Last year, government investigators found that the federal program for vetting the health of green card applicants included scores of doctors with histories of professional misconduct. Physicians who had been disciplined by state medical boards for abusing patients, and in some cases had faced criminal charges, had the government's blessing to conduct screenings that can decide the fate of an immigrant's petition for permanent residency.
The investigators found one doctor who had been convicted of hiring a hitman to kill a disgruntled patient, and in the same sample, found more than a hundred other physicians with serious disciplinary histories. The review concluded that U.S. Citizenship and Immigration Services, the agency that maintains the list of more than 5,000 doctors, inadequately vets the physicians, and that it often fails to follow its own standards. "As a result of these deficiencies, USCIS may be placing foreign nationals at risk of abuse by physicians performing medical examinations," investigators concluded.
Fifteen months after the audit was released, the list still includes scores of doctors with histories of professional misconduct similar to those flagged in the audit. In the directory of so-called civil surgeons, ProPublica found at least 150 doctors accused of patient abuse and negligence as of early December, and we determined that many of them are still offering the exam.Bottom of Form
One is James Richard Luu, of San Jose, California, who allowed his sister, an acupuncturist, to use his prescription pad and to treat patients with hemorrhoids in his office, misdiagnosing them and causing pain. Luu, 53, came to the United States as a refugee from Vietnam, and he and his sister placed ads in Vietnamese-language media to recruit patients from the immigrant population in San Jose. In 2011, Luu was charged with aiding and abetting the unlicensed practice of medicine in relation to his sister. He pleaded guilty, was sentenced to one day in jail and one year of probation. In 2014, the medical board put him on professional probation for three years.
He is currently offering immigration exams, and he said he has had no issues since he was put on probation in 2014. "Everything has been cleared."
Another doctor who was in the good graces of USCIS for years is Alvaro Genao, of New York City, who forged another physician's name to prescribe medications, including a potentially addictive sleep aid, to himself and others. After an investigation, the state medical board suspended his license in 2014, for professional misconduct and fraudulent practice. In 2017, the medical board withdrew the suspension, putting him on probation for 10 years.
Genao, 49, was still listed on the USCIS website until last week when he was removed after ProPublica contacted the agency. He did not respond to emails or text messages and hung up when a ProPublica reporter called him.
After the audit last year, USCIS promised to clean up the list and take actions to prevent green card applicants from being exposed to potential harm. But USCIS does not require any consideration of doctors' disciplinary histories when they apply for the program. The agency requires only that applicants have an active medical license, and almost all of the doctors on the list who have serious records do.
The audit noted that doctors who have had issues with misconduct in the past could still present a risk to patients. "Although some disciplinary conduct may have occurred years ago, the nature of the offense may continue to render these physicians a risk to those applying for immigration benefits," the report said.
It recommended that USCIS, which is part of the Department of Homeland Security, develop stricter standards, like those used by the Department of Health and Human Services, under which many of the physicians on the agency's directory could be disqualified. But the agency has already missed several self-imposed deadlines to make fixes. The audit also suggested using the National Practitioner Data Bank, a federal database, to bolster the vetting of doctors.
The doctor who was convicted of hiring the hitman was removed from the USCIS website this summer, along with about two dozen others. But our analysis found that as of early last week, more than a hundred doctors with records of unprofessional and sometimes dangerous behavior are still listed online.
After ProPublica contacted USCIS on Dec. 4 — and before it provided any response to our inquiry — the agency removed 16 more doctors with a history of misconduct from the website. In an email, the USCIS press office said, "Due to a computer glitch, civil surgeon revocations made in the past few weeks were not reflected online. USCIS has corrected the issue." But many of the doctors who were removed last week, including Genao, were disciplined several years ago.
Look Up Doctor Disciplinary Records
The list of doctors changes week to week, as it has in the course of our reporting.
One of the doctors with the USCIS stamp of approval admitted to a state medical board that in the early 1990s he had "sexual relations" with at least 16 of his patients. He is still listed online. Another doctor, who investigators found provided substandard care to green card seekers in a makeshift office without an exam table, was specifically barred from doing work related to USCIS. He was removed from the directory last week after ProPublica's inquiry.
To assess the state of the USCIS list, ProPublica analyzed the disciplinary records of doctors in the top five states for green card applications. In 2017, 57% of green card applications filed within the U.S. were sent from California, Florida, Texas, New York and New Jersey. We entered every ZIP code from those five states into the USCIS Find a Doctor website, and we looked up the medical board disciplinary record of each doctor who appeared in the search results.
We considered doctors to have a history of unprofessional or dangerous behavior if they had been disciplined for sexual misconduct, drug abuse, negligent patient care, inappropriate prescribing of controlled substances or deceptive practices. We did not include doctors who were disciplined for administrative errors like failing to submit a death certificate or not updating a practice's address with the medical board.
We found dozens of doctors who improperly prescribed controlled substances to themselves, friends or family members; some who violated patient privacy by revealing medical records to unauthorized people; some who failed to supervise assistants and technicians; and others who improperly diagnosed and documented medical conditions.
"It is horrible to know that there are doctors out there that have been disciplined for this type of action, and that they're responsible as gatekeepers to these immigrants," said Mario Urizar, an immigration lawyer in Miami whose firm handles more than 100 cases of green card applications annually.
The audit, issued in September 2018, was conducted by the inspector general for the Department of Homeland Security. It listed eight recommendations, including stricter requirements for doctors and improved training for the USCIS staff reviewing doctors' applications. USCIS agreed and set projected completion dates. Two of those dates have passed and two more are at the end of this year.
In an email, USCIS's press office wrote that the agency has "begun implementing the recommendations."
"USCIS concurred with last year's Inspector General report and continues toward implementation of recommendations, including drafting updated policy to develop stricter eligibility requirements for civil surgeons and strengthening the health-related inadmissibility training program," a spokeswoman, Marilu Cabrera, said in a statement.
While the Trump administration's focus on illegal immigration has captured the nation's attention, the federal government has also made the pathways to legal immigration more challenging. Immigration lawyers told ProPublica that recent changes in USCIS policies have made it difficult to correct mistakes in green card applications, raising the stakes for the immigrants, doctors and attorneys who fill out the forms.
The case of Fernando Romero illustrates how a single mistake by a USCIS-designated doctor — even one without a disciplinary record — can upend a petition for permanent residency. Romero, 41, traveled to Miami from Argentina almost two decades ago, when Argentine tourists could enter the U.S. with a visa waiver. He overstayed his visa waiver and was undocumented for several years. In 2016, he applied for a green card through his wife, also an Argentine immigrant, who had become a U.S. citizen years earlier. Last July, the petition was denied. In a letter, USCIS said it had turned down Romero's application because the doctor who examined him didn't include her contact information in the medical form. (The doctor who examined Romero is not on ProPublica's list of doctors with serious disciplinary records and declined to comment for this story.)
The letter from USCIS instructed Romero to make arrangements to leave the United States "as soon as possible." If he didn't, he could be barred from entering the country or receiving any immigration benefits, the letter said.
"When we got the letter, we panicked. My wife and I started wondering, what are we going to do? Are we going to have to return to Argentina?" said Romero, who installs wood flooring for a living. "I feared that the feds were going to knock on my door any day."
Under a past policy, implemented during the Obama administration, the USCIS officer working on Romero's case would have been likely to notify Romero about the missing contact information. But last September, the agency changed its policy. Now, officers aren't required to send a notification, although they can. The agency has said that it made the change to cut down on "frivolous" green card applications, and that it was not intended to penalize applicants for "innocent mistakes" or misunderstandings.
In October 2018, USCIS also changed the appointment system for many of its field offices, limiting in-person meetings between applicants or their attorneys and the agency's officers. In a press release, USCIS said the change was part of an effort to move more services online and reduce case processing times.
But attorneys say that these changes leave immigrants like Romero with few options to address issues with their applications.
In its letter denying Romero's green card petition, USCIS advised him that his only other option was to file a "motion to reopen or a motion to reconsider" his case, which carries a $675 filing fee. Even if that succeeded, it would have likely meant starting the costly and lengthy green card process all over again. In the meantime, neither his driver's license nor his work permit would be valid.
"The whole time while they do that, I essentially would have gone back to zero… as if I was here illegally again," said Romero, who had already spent more than $4,000 on the application and legal fees.
Romero said he called the agency dozens of times, hoping to correct the doctor's mistake by submitting a new medical form, instead of restarting the application process. But he said everyone he reached at USCIS referred him to the letter. He said that he and his wife talked to nearly 20 attorneys, but all of them offered only to file the motion. Eventually he reached Urizar, the lawyer in Miami, who suggested Romero sue USCIS. The lawsuit, filed in August, claimed that the USCIS was arbitrarily punishing Romero for a mistake by a doctor who was working on behalf of the agency. Two weeks later, the USCIS agreed to allow Romero to submit the corrected form and approved his green card.
The immigration medical forms are only valid for two years. If the process takes longer, an applicant would have to see a USCIS-designated doctor again and pay another exam charge. The medical exam, which is not covered by insurance, has no fixed price. In phone calls to doctors' offices, ProPublica was given prices ranging from $100 to $1,000.
Immigrants "are completely vulnerable because the doctor gives them the report in a sealed envelope to provide immigration with," Urizar said. "So not only are they not privy to their documents unless they ask for a copy, they have no say as to what immigration will decide on it."
According to USCIS, the purpose of the immigration medical exam is to protect public health. A green card applicant may be deemed inadmissible on medical grounds, a power established in the Immigration Act of 1891, which stated that entry could be denied to all "idiots, insane persons, paupers or persons likely to become a public charge," as well as "persons afflicted with tuberculosis or with a loathsome or dangerous contagious disease."
Although the conditions that could render a person inadmissible today are no longer described as loathsome, the same principles apply to current immigration exams. Tuberculosis remains a part of the screening, along with communicable diseases such as syphilis, gonorrhea and leprosy. Drug addiction, considered a disorder "associated with harmful behavior," is also listed as grounds for denying an immigrant entry.
Last year, just over 2,700 immigrant visa applications were rejected for medical reasons, according to data from the State Department. Nearly 1,000 of these applications cited communicable disease as the cause for ineligibility. The data does not show how many of these immigrant visas are connected to green card applications.
The list of conditions that could make an immigrant inadmissible has been the subject of controversy. The Centers for Disease Control and Prevention removed HIV from the list in 2010, stating that including HIV was "at odds with human rights considerations," after Congress repealed a travel ban on tourists and immigrants who were HIV-positive. Until 1973, when homosexuality was removed from the official list of mental illnesses in the U.S., the medical exam could be used to bar LGBTQ applicants.
The term civil surgeon is a holdover from the days of Ellis Island. The original screeners were officers of the U.S. Public Health Service, led by the surgeon general. Civil surgeons today do not have to be civil servants or surgeons. Most are private doctors, and the process to become certified is simple: Any physician who is authorized to work in the United States, has four years of professional experience and is licensed without restriction in the state where they work can apply by filling out a form and paying a $785 filing fee. State and local health department physicians and military physicians are automatically eligible.
Francisco Velazquez, an internist in the Houston area, said he became a USCIS-designated doctor to serve the immigrant community. Velazquez said he was motivated to join the program after hearing about clinics that were charging a lot and prescribing unnecessary vaccines.
"It's just a numbers game," Velazquez said. "It adds up, and if you're very greedy and you charge a little bit more here and there, the demand is there."
Velazquez, who became a civil surgeon last October, sees 30 to 40 patients a month for the immigration exam. He said that most of the immigrants who come to his office are working-class people who are referred by immigration attorneys. Others have found his office while calling different doctors looking for a price they can afford. He charges $265 per exam, plus the cost of any vaccinations the applicants need. To avoid mistakes, he says he types the information in the form, instead of writing by hand, and gives a copy to the patient to review.
Physicians in the program are required to follow the CDC's instructions for administering and evaluating the exams. The CDC also runs conferences and workshops for the doctors on how to administer the exams properly, but attendance is voluntary.
USCIS has a history of significant lags in updating and maintaining its list of approved doctors. In May 2017, the inspector general sent a list of 48 doctors to USCIS whose licenses were restricted or expired. It took several months for the agency to act, and in the end 11 of them were never removed.
Physicians are required to notify USCIS within 15 days if they stop practicing or stop administering immigration exams. The agency's press office said that when USCIS revokes a civil surgeon's designation, it removes that doctor from the directory. But ProPublica found at least a dozen physicians whose offices said they were no longer giving green card exams in mid November, even though they were still listed as doing so online.
According to the inspector general's report, USCIS relies on a contractor specializing in health care compliance to review the list of doctors twice a year and identify those with inactive or restricted licenses. Then, a USCIS employee manually reviews the results.
Last year, the inspector general's audit recommended that USCIS stop using the contractor, Evercheck. The audit called the agency's process inefficient and suggested that USCIS use the National Practitioner Data Bank, which is run by Health and Human Services.
USCIS's press office said in an email that the agency is still using Evercheck to confirm that physicians are licensed and to identify any restrictions on the licenses. The agency said it has increased license reviews to four times a year. The office also wrote that the agency is still "determining how best to utilize the National Practitioners Data Bank (NPDB) in a manner that is feasible, cost effective, and appropriate for the agency's needs."
In an email, Brian Solano, the CEO of Evercheck, said that the company has had the same contract with USCIS for several years, and that the terms have not changed. He said that he was not aware of the audit.
Solano wrote that Evercheck provides monthly reports of doctors' license statuses, including disciplinary actions taken against them. But it's up to USCIS to decide what to do with those reports.
"We're just alerting them of any changes on the license," Solano said. "And then they can make the business decision of what to do about it."
Of the audit's eight recommendations, all but one — creating a training program and quality control for the designation of physicians — remain open, according to Tanya Alridge, a spokeswoman for the inspector general. The inspector general's office said that agency liaisons check in on the status of open recommendations every 90 days, and that progress is reported to Congress twice a year.
How We Reported This Story
To assess the doctors authorized to perform immigration exams, ProPublica analyzed the disciplinary records of more than 4,000 doctors who are designated as civil surgeons. We scraped USCIS'Find a Doctor website, which is the public list of civil surgeons, according to USCIS's policy manual. We entered every ZIP code from the top five states for green card applications (California, Florida, Texas, New York and New Jersey) and scraped and saved those search results. For each doctor that showed up in the search results, we looked up their disciplinary record from the state medical board website, which is public information. We matched the doctors on their first and last name (and middle name, if one was listed), and the state in which they were listed as practicing on USCIS' website. If multiple doctors had the same name in the same state, we cross-checked the name of their practice and ZIP code.
We read through the medical board findings on each doctor's misconduct. We considered doctors to have a record of unprofessional behavior if they had been disciplined for sexual misconduct, drug abuse, negligent patient care, inappropriate prescribing of controlled substances or deceptive practices. For example, we included doctors that prescribed controlled substances to their friends and family members, posted false advertisements about their treatments, administered watered down or expired vaccines and medications, sexually assaulted and harassed patients, and allowed staff members who were not medically trained to treat patients. We did not include doctors that were disciplined for administrative errors, such as failing to submit a death certificate or neglecting to update information such as their address or phone number with the medical board.
Lexi Churchill, Nate Schweber and John Surico contributed reporting.