While hospital patients can get the findings back within a day, people getting tested at urgent care centers, community health centers, pharmacies and government-run drive-thru or walk-up sites are often waiting a week or more.
This article was first published on Thursday, July 9, 2020 in Kaiser Health News.
Elliot Truslow went to a CVS drugstore on June 15 in Tucson, Arizona, to get tested for the coronavirus. The drive-thru nasal swab test took less than 15 minutes.
More than 22 days later, the University of Arizona graduate student was still waiting for results.
Truslow was initially told it would take two to four days. Then CVS said five or six days. On the sixth day, the pharmacy estimated it would take 10 days.
“This is outrageous,” said Truslow, 30, who has been quarantining at home since attending a large rally at the school to demonstrate support of Black Lives Matter. Truslow has never had any symptoms. At this point, the test findings hardly matter anymore.
Truslow’s experience is an extreme example of the growing and often excruciating waits for COVID-19 test results in the United States.
While hospital patients can get the findings back within a day, people getting tested at urgent care centers, community health centers, pharmacies and government-run drive-thru or walk-up sites are often waiting a week or more. In the spring, it was generally three or four days.
The problems mean patients and their physicians don’t have information necessary to know whether to change their behavior. Health experts advise people to act as if they have COVID-19 while waiting — meaning to self-quarantine and limit exposure to others. But they acknowledge that’s not realistic if people have to wait a week or more.
Atlanta Mayor Keisha Lance Bottoms, who announced Monday that she had tested positive for the virus, complained she waited eight days for her results in an interview on MSNBC Wednesday. During that time, she held a number of meetings with city officials and constituents — “things that I personally would have done differently had I known there was a positive test result in my house,” she said on “Morning Joe.”
“We’ve been testing for months now in America,” she added. “The fact that we can’t quickly get results back so that other people are not unintentionally exposed is the reason we are continuing in this spiral with COVID-19.”
The slow turnaround for results could also delay students’ return to school campuses this fall. It’s already keeping some professional baseball teams from training for a late July start of the season. The lag times could even foil Hawaii’s plan to welcome more tourists. The state had been requiring visitors to quarantine for 14 days, but it announced last month that starting Aug. 1 that mandate would be lifted for people who could show they tested negative within three days before arriving in the islands.
In California, Gov. Gavin Newsom noted the problem when addressing reporters Wednesday. “We were really making progress as a nation, not just as a state, and now you’re starting to see, because of backlogs with [the lab company] Quest and others, that we’re experiencing multiday delays,” he said.
The delays even apply to people in high-risk, vulnerable populations, he said, citing a massive outbreak at San Quentin State Prison, which has been sending its tests to Quest. The state is now looking at partnering with local labs, hoping they can provide faster turnaround.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said the long waits spell trouble for individuals and complicate the national response to the pandemic.
“It defeats the usefulness of the test,” he said. “We need to find a way to make testing more robust so people can function and know if they can resume normal activities or go back to work.”
The problem is that labs running the tests are overwhelmed as demand has soared in the past month.
“We recognize that these test results contain actionable information necessary to guide treatment and inform public health efforts,” said Julie Khani, president of the American Clinical Laboratory Association, a trade group. “As laboratories respond to unprecedented spikes in demand for testing, we recognize our continued responsibility to deliver accurate and reliable results as quickly as possible.”
Dr. Temple Robinson, CEO of Bond Community Health Center in Tallahassee, Florida, said test results have gone from a three-day turnaround to 10 days in the past several weeks. Many poor patients don’t have the ability to easily isolate from others because they live in smaller homes with other people. “People are trying to play by the rules, but you are not giving them the tools to help them if they do not know if they tested positive or negative,” she said.
“If we are not getting people results for at least seven or eight days, it’s an exercise in futility because either people are much worse or they are better” by then, she said.
Given the lag in testing results from big lab companies, Robinson said her health center this month bought a rapid test machine. She held off buying the machine due to concerns the tests produced a high number of false-negative results but went ahead earlier this month in order to curtail the long waits, she said.
Robinson doesn’t blame the large labs and points instead to the surge in testing. “We are all drinking through a firehose, and none of the labs was prepared for this volume of testing,” she said. “It’s a very scary time.”
Azza Altiraifi, 26, of Vienna, Virginia, knows that all too well. She started feeling sick with respiratory symptoms and had trouble breathing on June 28. Within a few days she had chills, aches and joint pain and then a needling sensation in her feet. She went to her local CVS to get tested on July 1. She was still awaiting the result July 8.
What is most frustrating about her situation is that her husband is a paramedic, and his employer won’t let him work because he may have been exposed to the virus. He was tested July 6 and is still awaiting news.
“This is completely absurd,” Altiraifi said. She also worries that her husband may have unknowingly passed on the virus on one of his ambulance calls to nursing homes and other care facilities before he began isolating at home. He has not shown any symptoms.
Altiraifi, who still has symptoms including fatigue, said she was initially told she would have results in two to four days, but she was suspicious because after using a nasal swab to give herself the test, the box to put it in was so full it was hard to close.
Charlie Rice-Minoso, a spokesperson for CVS Health, said patients are waiting five to seven days on average for test results. “As demand for tests has increased, we’ve seen test result turnaround times vary due to temporary processing capacity limitations with our lab partners, which they are working to address,” he said.
In South Florida, the Health Care District of Palm Beach County, which has tested tens of thousands of patients since March, said findings are taking seven to nine days, several days longer than in the spring.
CityMD, a large urgent care chain in the New York City area, said it now tells patients they will likely wait at least seven days for results because of delays at Quest Diagnostics.
Quest Diagnostics, one of the largest lab companies in the United States, said average turnaround time has increased from three to five days to four to six days in the past two weeks. The company has performed nearly 7 million COVID tests this year.
“Quest is doing everything it can to add testing capacity to reduce turnaround times for patients and providers amid this crisis and the unprecedented demands it places on lab providers,” said spokesperson Kimberly Gorode.
At Treasure Coast Community Health in Vero Beach, Florida, officials are advising patients of a 10- to 12-day wait for results.
CEO Vicki Soule said Treasure Coast is deluged with calls every day from patients wanting to know where their test results are.
“The anxiety on the calls is way up,” she said.
Julie Hall, 48, of Chantilly, Virginia, got tested June 27 at an urgent care center after learning that her husband had tested positive for COVID-19 as he prepared for hip replacement surgery. She was dismayed to have to wait until July 3 to get an answer.
“I was thrilled to be negative, but by that point it likely did not matter,” she said, noting that neither she nor her husband, Chris, showed any symptoms.
“It was awful and terrible because of the unknowns and not knowing if you exposed someone else,” she said of being quarantined at home awaiting results. “Whenever you would sneeze, someone would say ‘COVID’ even though you feel completely fine.”
Senior correspondent Anna Maria Barry-Jester in California contributed to this article.
"If Donald Trump has his way, complications from COVID-19 could become a new preexisting condition," says former Vice President Joe Biden during a campaign speech in Lancaster, Pennsylvania.
This article was first published on Thursday, July 9, 2020 in Kaiser Health News.
The same day the Trump administration reaffirmed its support of a lawsuit that would invalidate all of the Affordable Care Act, Joe Biden sharply warned that the suit endangers millions of Americans.
The presumptive Democratic presidential nominee said the law is even more important now, more than a decade after it was enacted, as the COVID-19 epidemic sweeps the U.S. The virus has killed more than 130,000, and Biden noted that some who survive may have long-lasting health problems.
His speech in the battleground state of Pennsylvania focused on a legal challenge headed to the Supreme Court and the fallout if the court upholds a 2018 U.S. District Court decision that struck down the entire ACA, including preexisting condition protections that bar insurers from rejecting people with medical problems or charging them more.
“And perhaps most cruelly of all, if Donald Trump has his way, complications from COVID-19 could become a new preexisting condition,” Biden said.
The Trump administration has supported the challenge. A decision from the Supreme Court is expected next year, after the November presidential election.
But would a decision against the health law affect COVID-19 patients in the way Biden described?
We decided to check because it’s likely to come up a lot in the presidential electioneering. We reached out to the Biden campaign to find out the basis for his statement. A campaign spokesperson responded by reiterating the points made by the former vice president in his speech and sharing various news stories about COVID-19 and the preexisting condition coverage issue.
Several law and health policy experts noted that Biden is on fairly firm ground, though the issue — like many others in health care — is complicated.
First, A Little History
Before the ACA went into effect in 2014, insurers on the private market could reject applicants for coverage if they had any number of medical conditions, such as cancer, depression, heart disease — even high blood pressure, acne or plantar fasciitis. Consumers had to fill out forms listing their medical conditions when applying for coverage. An estimated 54 million Americans have a preexisting condition that could have led to a denial under pre-ACA rules, researchers estimate.
Also, at the time, some consumers had coverage cancelled retroactively once they fell ill with a serious or costly disease, as insurers would then comb through years of medical records looking for anything the consumer had failed to report as preexisting, even if it seemed to have little or nothing to do with the patient’s current medical concern.
Those rejections and cancellations mainly affected people who bought their own coverage, not those who got insurance through their jobs.
Job-based coverage, which is the main way most insured people get their plans, had some protections prior to the passage of the ACA. For example, the federal Health Insurance Portability and Accountability Act of 1996 said people who held health insurance continuously for at least a year could not face preexisting condition limits when they enrolled in a new employer plan, as long as they didn’t go uninsured for more than 63 days.
Those who didn’t meet that yearlong coverage requirement or went uninsured between jobs could find their medical conditions excluded for up to a year in a new group plan.
Before the ACA, insurers broadly defined preexisting conditions. Many included any condition for which a patient had received treatment, or even undiagnosed conditions for which a reasonable person should have sought treatment.
The ACA changed that. Among other things, it barred insurers from rejecting applicants based on their health, excluding coverage of preexisting medical conditions and charging sick people more than healthier ones. It also ended annual or lifetime dollar limits on coverage and said employers that offer insurance can’t make new workers wait more than 90 days for coverage to kick in.
Could COVID-19 Become A Preexisting Condition?
Biden’s comment raises the question of whether COVID-19 would be considered a preexisting condition in a future without the sweeping health law on the books.
Because the virus is so new, there’s no definitive answer on its long-term health effects.
But media reports note hospitals and physician groups are finding evidence that some recovered COVID patients suffer from lung damage, blood clots, neurological conditions, strokes or fatigue.
Researchers are now starting to follow patients to track long-term effects.
Given insurers’ history, it’s certainly reasonable to assume they would put what are now cropping up as potential COVID complications in the preexisting-condition category, said Sabrina Corlette, who studies the individual insurance market as co-director of the Center on Health Insurance Reforms at Georgetown University.
“There is a real concern that if those preexisting condition protections are overruled or taken down by the Supreme Court, people who have COVID-19 could be medically underwritten, charged more or be denied a policy,” said Corlette.
That is possible, said Joe Antos, resident scholar in health policy at the conservative American Enterprise Institute. But many of the people most likely to suffer complications from the coronavirus likely already had conditions like diabetes, asthma or heart disease that would already have put them in danger of being rejected for coverage under pre-ACA business practices, he added.
In other words, COVID-19 could simply find a place on a long list of other conditions that could disqualify consumers from obtaining insurance.
And even if the high court tossed out the ACA, insurers might choose to keep offering coverage to people with health problems, say some analysts, including Antos.
But this take triggers skepticism.
“Insurance companies have an obligation to shareholders, and that obligation is to maximize profits,” Corlette said. “They don’t do that by covering a lot of sick people when competitors are not doing it.”
The Biggest Unknown
Just how would Congress and the president react if the ACA is struck down?
Under a Biden presidency, coupled with Democrats holding the House and possibly winning the Senate, the ACA would definitely be replaced, the experts all agreed.
Under a second-term Trump administration, Republicans would face a dilemma because — even though the party has called for the law’s repeal since its enactment –— they have been unable to agree on how to replace it. Yet polls have consistently shown that parts of the law, especially the preexisting condition protections, are very popular with a wide swath of voters.
“They don’t want to come across as coming up hard against people who have health conditions,” said Antos.
Private practice attorney Christopher Condeluci, who served as tax and benefit counsel to the Senate Finance Committee when the ACA was drafted, agreed. He thinks Congress or the president would act to save the preexisting condition protections at least.
But how to do so is problematic. That provision is intricately tied with many other parts of the ACA, those aimed at getting as many healthy people to enroll as possible in order to spread costs out among the many, rather than the few.
The ACA did that partly by requiring most Americans to carry insurance coverage — the provision at the heart of the Texas lawsuit seeking to overturn the legislation. Restoring that requirement might be tricky, so the path forward for a split Congress or a second-term Trump presidency to come up with a solution quickly — or at all — if the Supreme Court tosses the entire law is a difficult one.
Our Ruling
Biden said that if Trump had his way, COVID complications could become a preexisting condition. He said this while discussing what might happen if the ACA is overturned by the Supreme Court. Though the statement can’t be definitively proven, there’s a lot of evidence backing it up.
First, some patients are showing at least short-term aftereffects of COVID-19, some of which could be costly. Some may prove long-term.
Second, insurers dislike costly medical conditions. Their business model is designed to have enough healthy enrollees to offset those with costly conditions. Before the ACA, they did that by rejecting people with medical conditions, charging them more or excluding coverage for those conditions. Some also temporarily delayed coverage for specific conditions in group plans offered by employers. Without the ACA, no federal law would prevent them from returning to these practices when selling plans on the individual market.
Hospitals say they are more prepared to handle the crush of patients because they have enough protective gear for their workers and know how to better treat coronavirus patients.
This article was first published on Thursday, July 9, 2020 inKaiser Health News.
Three months ago, the nation watched as COVID-19 patients overwhelmed New York City's intensive care units, forcing some of its hospitals to convert cafeterias into wards and pitch tents in parking lots.
Hospitals elsewhere prepped for a similar surge: They cleared beds, stockpiled scarce protective equipment, and — voluntarily or under government orders — temporarily canceled nonemergency surgeries to save space and supplies for coronavirus patients.
In most places, that surge in patients never materialized.
Now, coronavirus cases are skyrocketing nationally and hospitalizations are climbing at an alarming rate. But the response from hospitals is markedly different.
Most hospitals around the country are not canceling elective surgeries — nor are government officials asking them to.
Instead, hospitals say they are more prepared to handle the crush of patients because they have enough protective gear for their workers and know how to better treat coronavirus patients. They say they will shut down nonessential procedures at hospitals based on local assessments of risk, but not across whole systems or states.
Some hospitals have already done so, including facilities in South Florida, Phoenix and California's Central Valley. And in a few cases, such as in Texas and Mississippi, government officials have ordered hospitals to suspend elective surgeries.
Hospitals' decisions to keep operating rooms open are being guided partly by money. Elective surgeries account for a significant portion of hospital revenue, and the American Hospital Association estimates that the country's hospitals and health care systems lost $202.6 billion between March 1 and June 30.
"What we now realize is that shutting down the entire health care system in anticipation of a surge is not the best option," said Carmela Coyle, president of the California Hospital Association. "It will bankrupt the health care delivery system."
The associationprojects that California hospitals will lose $14.6 billion this year, of which $4.6 billion has so far been reimbursed by the federal government.
But some health care workers fear that continuing elective surgeries amid a surge puts them and their patients at risk. For instance, some nurses are still being asked to reuse protective equipment like N95 masks and gowns, even though hospitals say they have enough gear to perform elective surgeries, said Zenei Cortez, president of the National Nurses United union.
"They continue to put us at risk," Cortez said. "They continue to look at us as if we are disposable material."
Elective surgeries, generally speaking, are procedures that can be delayed without harming patients, such as knee replacements and cataract surgery.
At least 33 states and the District of Columbia temporarily banned elective surgeries this spring, and most hospitals in states that didn't ban them, such as Georgia and California, voluntarily suspended them to make sure they had the beds to accommodate a surge of coronavirus patients. The U.S. surgeon general, the Centers for Disease Control and Prevention and the American College of Surgeons also recommended health care facilities suspend nonemergency surgeries.
The suspension was always intended to be temporary, said Dr. David Hoyt, executive director of the American College of Surgeons. "When this all started, it was simply a matter of overwhelming the system," he said.
Today, case counts are soaring after many states loosened stay-at-home orders and Americans flocked to restaurants, bars and backyards and met up with friends and family for graduation parties and Memorial Day celebrations.
Nationally, confirmed cases of COVID-19 have topped 3 million. In California, cases are spiking, with a 52% jump in the average number of daily cases over the past 14 days, compared with the two previous weeks. Hospitalizations have gone up 44%.
Governors, county supervisors and city councils have responded by requiring people to wear masks, shutting down bars and restaurants — again — and closing beaches on the July Fourth holiday weekend.
But by and large, government leaders are not calling on hospitals to proactively scale back elective surgeries in preparation for a surge.
"Our hospitals are telling us they feel very strongly and competent they can manage their resources," said Holly Ward, director of marketing and communications at the Arizona Hospital and Healthcare Association. If they feel the situation warrants it, "they on their own will delay surgeries."
In some states, like Colorado, public health orders that allowed hospitals to resume nonemergency surgeries in the spring required hospitals to have a stockpile of protective equipment and extra beds that could be used to treat an influx of COVID-19 patients.
States also set up overflow sites should hospitals run out of room. In Maryland, for example, the state is using the Baltimore Convention Center as a field hospital. The state of California last week reactivated four "alternative care sites" — including a hospital that was on the verge of closure in the San Francisco Bay Area — to take COVID-19 patients should hospitals fill up.
But the decision to reduce elective surgeries in California will not come from the state. It will be made by counties in consultation with hospitals, said Rodger Butler, a spokesperson for the California Health and Human Services Agency.
The question is whether hospitals have systems in place to meet a surge in COVID-19 patients when it occurs, said Glenn Melnick, a professor of health economics at the University of Southern California.
"To some extent, elective care is good care," Melnick said "They're providing needed services. They are keeping the system going. They are providing employment and income."
In Los Angeles County, more than 2,000 COVID patients are currently hospitalized, according to county data. While that number is projected to go up by a couple of hundred people over the next few weeks, hospitals believe they can accommodate them, said county Health Services Director Christina Ghaly. In the meantime, hospitals are preparing to bring on additional staff members if needed and informing patients who have scheduled surgeries that they could be delayed.
"There's more patients with COVID in the hospitals than there has been at any point previously in Los Angeles County during the pandemic," Ghaly said. "Hospitals are more prepared now for handling that volume of patients than they were previously."
While hospitals have not stopped elective surgeries, many have not ramped up to the full schedule they had before COVID-19. And they say they are picking and choosing surgeries based on what's happening in their area.
"We were all things COVID when it was just starting," said Joshua Adler, executive vice president for physician services at UCSF Health. "We didn't know what we were facing."
But after a couple of months of treating patients, hospitals have learned how to resupply units, how to transfer patients, how to simultaneously care for other patients and how to improve testing, Adler said.
At Scripps Health in San Diego, which has taken more than 230 patients from hard-hit Imperial County to the east, its hospitals have scaled back how many transfers they will accept as confirmed COVID-19 cases rise in their own community, said Chris Van Gorder, president and CEO of Scripps Health.
A command center set up by the hospital system reviews patient counts and medical supplies and coordinates with county health officials to study how the virus is spreading. Only patients who need urgent surgeries are being scheduled, Van Gorder said.
"We're only allowing our doctors to schedule cases two weeks out," Van Gorder said. "If we see a sudden spike, we have to delay."
In California's Central Valley and in Phoenix, where cases and hospitalizations are surging, Mercy hospitals have suspended elective surgeries to focus resources on COVID-19 patients.
But the other hospitals in the CommonSpirit Health system, which has 137 hospitals in 21 states, are not ending elective surgeries — as they did in the spring — and are treating patients with needs other than COVID, said Marvin O'Quinn, the system's president and chief operating officer.
"In many cases their health deteriorated because they didn't get care that they needed," said O'Quinn, whose hospitals lost close to a $1 billion in two months. "It's not only a disservice to the hospital to not do those cases; it's a disservice to the community."
HOUSTON — The Fourth of July was a little different this year here in Texas’ biggest city. Parades were canceled and some of the region’s beaches were closed. At the city’s biggest fireworks show, “Freedom Over Texas,” fireworks were shot higher in the air to make it easier to watch from a distance. Other fireworks displays encouraged people to stay in their cars.
After weeks of surging COVID-19 cases and dire warnings that Houston’s massive medical infrastructure would not be able to keep pace, Republican Gov. Greg Abbott issued an executive order on July 2 requiring Texans to wear masks in public, after previously reversing course on the state’s reopening by again closing bars and reducing restaurant capacity.
While most Houstonians appear to be taking heed, not everyone is on board. Small protests against the orders occurred over the holiday weekend. Lawsuits have been filed. At least one Houston-area law enforcement agency said it would not enforce the mask requirement. The State Republican Executive Committee plans to hold its mid-July convention downtown, drawing an expected 6,000 people from around the state.
Democratic Mayor Sylvester Turner said he and other local leaders sent a letter to GOP leaders asking them to convert the convention into a virtual event. But the party remains steadfast.
“There simply is no substitute for the in-person debate we value so strongly,” Texas GOP Chairman James Dickey said, adding that the party committee explicitly affirmed it would not voluntarily cancel the convention. He said there would be thermal scanners, social distancing, deep cleaning between meetings, hand sanitizer and thousands of donated masks available for those in attendance.
“My sincerest sympathies go out to anyone who is affected by any severe disease, including this one,” he said. “But on a per capita basis, Harris County, and Texas in general, are both dramatically better than most of the states in the United States.”
However, confirmed cases in Houston’s surrounding county, Harris, more than doubled in a month to reach more than 37,000 positive cases as of July 6. Hospitals in the Texas Medical Center had 2,261 COVID-positive patients that day in intensive care or medical-surgical units, up from 1,747 the week before, according to the center’s tracking website. All told, the nine-county Houston region has had more than 52,000 confirmed cases and 572 deaths.
The Texas Medical Center has predicted that unless the spread of the virus is mitigated, Houston hospitals could exceed existing capacity by mid-July. A federal assessment team came to Houston to determine how the federal government can help the city respond to the current surge.
Local officials had tried to protect Houston. Early in the pandemic, Harris County Judge Lina Hidalgo, a Democrat who serves as the county’s top elected leader, implemented business closures and stay-at-home and masking orders. But Lt. Gov. Dan Patrick and U.S. Rep. Dan Crenshaw, both Republicans, called them an “overreach” that “could lead to unjust tyranny.” On April 27, Abbott overruled the county guidance, and announced plans to reopen businesses and relax social distancing guidelines.
For those who live in Houston, it’s all meant lots of confusion.
“This whole thing has been a messaging nightmare from the beginning,” said Joe Garcia, 50, who works in data management. “When a flood happens, when a hurricane happens, nobody cares what side you’re on — blue, red, whatever else — all you know is it’s a disaster and everybody comes in and helps. That’s just the way things are. This wasn’t treated as a disaster.”
Public discourse about the pandemic has been disheartening, said Norma Ybarbo, 55, who avoids leaving home beyond socially distant visits with her father and attending a lightly populated early morning mass. She said the political arguments and conflicting communication from the Texas Medical Center in June about hospital capacity have made an already stressful situation worse.
“It’s worrisome, for sure,” Ybarbo said. “It’s really hard to determine what is right and what is true.”
Marine veteran S.D. Panter, 44, said it all has deepened his concern about bias in doctors and politicians who are advocating for businesses to be shut down. Panter, who doesn’t deny the virus is troublesome, said he prefers to do his own research because, for him, the dire picture being painted by those in the spotlight doesn’t make sense. He does wear a mask in public, even though he is not sure it is necessary.
“There’s just so much information. Just let me make my own decision, my own informed decision,” said Panter, who helps his parents and his wife’s parents stay socially isolated. “The older population should probably stay indoors, and let’s protect them the best we can.”
The state’s reopening this spring coincided with Mother’s Day, graduations, Memorial Day and Black Lives Matter protests. Once Texans were released from pandemic-induced restrictions, many happily took advantage of the chance to socialize.
Alyssa Guerra, 27, who lost her job when the store she managed closed, said she now knows people who have contracted the virus, and a few who have become sick or lost loved ones. She has friends who went to bars and social events, without masks, when the state reopened. She went out to eat once, but felt so uncomfortable she hasn’t done it since.
“It’s affecting us in greater numbers now because of the selfish decisions we are making,” said Guerra. “At some point, yes, we are going to have to start living our lives again, but we did it so quickly this time that people just had no care in the world.”
While the number of confirmed COVID-19 infections is rising in all age groups here, those seeing the most rapid growth in positive tests and hospitalizations are 20 to 40 years old. Dr. David Persse, public health authority with the Houston Health Department, said recently that 15% of COVID patients being admitted to the hospital are younger than 50, and 30% are younger than 60.
That could explain lower rates of death now than earlier in the pandemic, said Dr. Angela Shippy, chief medical and quality officer at Memorial Hermann Health System. Another reason for the lower death rates could be that providers have learned more effective treatments for the virus, using different respiratory and drug therapies to avoid intensive care units and intubation.
Still, Houston’s hospitals are being challenged by the rapid spike in COVID patients as a whole. Without taking steps to slow the spread of the virus, hospitals could become unable to manage the load. That has been the message from hospitals — including in multiple full-page ads in the Houston Chronicle advising people to stay home or wear a mask in public.
“We still have the ability to grow capacity, but there will come a limit to how much capacity you can grow,” said Roberta Schwartz, executive vice president, chief innovation officer and CEO of Houston Methodist Hospital.
The area’s public hospitals, which had been steadily handling COVID cases since March, have been transferring adult patients the past several weeks to private hospitals, including Texas Children’s Hospital, which had 29 COVID patients as of July 6. Houston Fire Chief Sam Peña said it has been taking an hour, in some cases, to transfer patients from ambulances to some emergency rooms — which Schwartz said have been “inundated.”
The fire and police departments have large numbers of staff in quarantine. Hospitals report staffers are testing positive, which they attribute to contracting the virus outside the hospital. Some area hospitals are bringing in traveling nurses to help.
“We encourage everyone to do their part and always wear a mask when leaving home, wash your hands often and maintain social distance,” Mark A. Wallace, president and CEO of Texas Children’s Hospital, said in an emailed statement. “This is the best way to protect yourself, your loved ones and our health care workers.”
A COVID-19 vaccine will have an actual price tag. And given the prevailing business-centric model of American drug pricing, it could well be budget breaking, perhaps making it unavailable to many.
This article was first published on Wednesday, July 8, 2020 inKaiser Health News.
Yes, of course, Americans' health is priceless, and reining in a deadly virus that has trashed the economy would be invaluable.
But a COVID-19 vaccine will have an actual price tag. And given the prevailing business-centric model of American drug pricing, it could well be budget breaking, perhaps making it unavailable to many.
The last vaccine to quell a global viral scourge was the polio inoculation, which ended outbreaks that killed thousands and paralyzed tens of thousands each year in the United States. The March of Dimes Foundation covered the nominal drug cost for a free national vaccination program.
It came in the mid-1950s, before health insurance for outpatient care was common, before new drugs were protected by multiple patents, before medical research was regarded as a way to become rich. It was not patented because it was not considered patentable under the standards at the time.
Now we are looking for viral deliverance when drug development is one of the world's most lucrative businesses, ownership of drug patents is disputed in endless court battles, and monopoly power often lets manufacturers set any price, no matter how extraordinary. A new cancer treatment can cost a half-million dollars, and old staples like insulin have risen manifold in price to thousands of dollars annually.
And the American government has no effective way to fight back.
Recent vaccines targeting more limited populations, such as a meningitis B vaccine for college students and the shingles vaccine for older adults, have a retail cost of $300 to $400 for a full course.
If a COVID-19 vaccine yields a price of, say, $500 a course, vaccinating the entire population would bring a company over $150 billion, almost all of it profit.
Dr. Kevin Schulman, a physician-economist at the Stanford Graduate School of Business, called that amount "staggering." But Katherine Baicker, dean of the University of Chicago Harris School of Public Policy, said that from society's perspective "$150 billion might not be an unreasonable sum" to pay to tame an epidemic that has left millions unemployed and cost the economy trillions.
Every other developed country has evolved schemes to set or negotiate prices, while balancing cost, efficacy and social good. The United States instead has let business calculations drive drug price tags, forcing us to accept and absorb ever higher costs. That feels particularly galling for treatments and vaccines against COVID-19, whose development and production is being subsidized and incentivized with billions in federal investment.
When AZT, the first effective drug for combating the virus that causes AIDS, was introduced in 1992, it was priced at up to $10,000 a year or about $800 a month. It was the most expensive prescription drug in history, at that time. The price was widely denounced as "inhuman." Today that price gets you some drugs for toenail fungus.
Investors already smell big money for a COVID-19 vaccine.
The market cap of Moderna, a small Boston-area company that has partnered with the National Institutes of Health in the vaccine race, has tripled since Feb. 20, to $23 billion from $7 billion, turning its chief executive into an overnight billionaire. While Moderna's vaccine is regarded as a strong contender, the company has never brought a successful drug to market.
Manufacturers have traditionally claimed that only the lure of windfall profits would encourage them to take the necessary risks, since drug development is expensive and there's no way of knowing whether they're putting their money on a horse that will finish first, or scratch.
More recently they have justified high prices by comparing them with the costs they would prevent. Expensive hepatitis C drugs, they say, avoid the need for a $1 million liver transplant. No matter that the comparison being made is to the highly inflated costs of treating disease in American hospitals.
Such logic would be disastrous if it were applied to a successful COVID vaccine. COVID-19 has shut down countless businesses, creating record-high unemployment. And the medical consequences of severe COVID-19 mean weeks of highly expensive intensive care.
"Maybe the economic value of the COVID vaccine is a trillion — and even if the expense to the company was a billion, that's 1,000 times return on investment," said Schulman. "No economic theory would support that."
In 2015, the Senate Finance Committee came up with a simpler explanation for high drug prices. After reviewing 20,000 pages of company documents, it found that Gilead Sciences had what the committee's ranking Democratic member, Ron Wyden of Oregon, called"a calculated scheme for pricing and marketing its hepatitis C drug based on one primary goal, maximizing revenue."
In setting prices, drugmakers rarely acknowledge the considerable federal funding and research that have helped develop their products; they have not offered taxpayer-investors financial payback.
The Biomedical Advanced Research and Development Authority, a federal agency known as BARDA, is giving Moderna up to $483 million for late-stage development of its vaccine.
The basic science that has allowed the small company to move so rapidly was developed with a huge prior infusion of federal money to come up with a treatment for diseases like Zika.
Francis Collins, the head of the National Institutes of Health, has said the government has some intellectual property rights. Moderna seems to dispute that view, saying it is "not aware of any I.P. that would prevent us from commercializing" a COVID-19 vaccine.
Likewise, AstraZeneca, a top competitor, has received a BARDA promise of up to $1.2 billion for commercializing a product derived from research at the University of Oxford.
There is no simple, direct mechanism for regulators or legislators to control pricing. Our laws, in fact, favor business: Medicare is not allowed to engage in price negotiations for medicines covered by its Part D drug plan. The Food and Drug Administration, which will have to approve the manufacturer's vaccine for use as "safe and effective," is not allowed to consider proposed cost. The panels that recommend approval of new drugs generally have no idea how they will be priced.
"The idea that we would allow ourselves to be held hostage in an emergency is mind-boggling," said David Mitchell, head of Patients for Affordable Drugs, an advocacy group.
That's why a bipartisan coalition in the House recently proposed two new bills to prevent "price gouging" for "taxpayer funded COVID-19 drugs" to ensure affordable pricing.
The exact mechanisms for enacting the provisions therein — such as requiring manufacturers to reveal their development costs — remain unclear. The industry has previously protected development data as a trade secret. The bills would also require "reasonable pricing clauses" be included in agreements between drug companies and agencies funding their work. They propose waiving exclusive licenses for COVID-19 drugs, allowing competitors to sell the same products as long as they pay the patent holder royalties.
Other countries, such as Britain, take a more head-on approach: a national body does a cost-benefit analysis regarding the price at which a new drug is worth being made available to its citizens. Health authorities then use that information to negotiate with a drugmaker on price and to develop a national reimbursement plan.
We could, too, but would need to consider mechanisms outside of our current box — at least for this national emergency.
The federal government could, for example, invoke a never-before-used power called "march-in rights," through which it can override a patent holder's rights if it doesn't make its medicines "available to the public on reasonable terms." (Unfortunately, in already-signed agreements with BARDA, some drugmakers have explicitly watered down or eliminated that proviso.)
We could, alternatively, allow Medicare to negotiate drug prices — a proposal that has been raised by politicians and beaten back by industry again and again. We would then need to restrict markup for a COVID-19 vaccine for the private market. Otherwise, we'd get the kinds of results emerging from the COVID testing industry, where Medicare pays $100 for the test but some labs charge insurers over $2,000.
There is already reason to worry that our deliverance from the coronavirus will cost us plenty. BARDA paid AztraZeneca up to $1.2 billion toward development, production and delivery of its candidate vaccine, in order to secure 300 million doses in October. Britainpaid the equivalent of $80 million to secure 100 million doses in September — one-fifth of what the United States government agreed to pay per dose.
Baicker, the public policy school dean, thinks public scrutiny will prevent outrageous pricing. The industry has made various pledges, trying to balance corporate citizenship against making eager investors happy: Astra Zeneca has promised 1 billion doses for low- and middle-income countries. Johnson & Johnson says it would make the COVID-19 vaccine available on a "not for profit basis" at $10 for "emergency pandemic use."
We've heard such offers before. Pharmaceutical companies routinely provide coupons to cover patient copayments for expensive drugs so that we don't squawk when they charge our insurance company tens of thousands for the medicine, driving up premiums year after year. A naloxone injector to reverse heroin overdoses is given free to some clinics, but priced at thousands for the rest.
And it won't feel like a bargain if we get free or cheap vaccines during a pandemic but pay dearly for annual COVID-19 shots thereafter.
Drug companies deserve a reasonable profit for taking on this urgent task of creating a COVID-19 vaccine. But we deserve a return, too.
So before these invaluable vaccines hit the market, we should talk about an actual price. Otherwise, we will be stuck paying dearly for shots that the rest of the world will get for much less.
Healthcare workers on the front lines of the COVID crisis have spent exhausting months working and self-quarantining off-duty to keep from infecting others. Encountering people who indignantly refuse face coverings can feel like a slap in the face.
This article was first published on Tuesday, July 7, 2020 in Kaiser Health News.
When an employee told a group of 20-somethings they needed face masks to enter his fast-food restaurant, one woman fired off a stream of expletives. "Isn't this Orange County?" snapped a man in the group. "We don't have to wear masks!"
The curses came as a shock, but not really a surprise, to Nilu Patel, a certified registered nurse anesthetist at nearby University of California-Irvine Medical Center, who observed the conflict while waiting for takeout. Health care workers suffer these angry encounters daily as they move between treacherous hospital settings and their communities, where mixed messaging from politicians has muddied common-sense public health precautions.
"Healthcare workers are scared, but we show up to work every single day," Patel said. Wearing masks, she said, "is a very small thing to ask."
Patel administers anesthesia to patients in the operating room, and her husband is also a health care worker. They've suffered sleepless nights worrying about how to keep their two young children safe and schooled at home. The small but vocal chorus of people who view face coverings as a violation of their rights makes it all worse, she said.
That resistance to the public health advice didn't grow in a vacuum. Health care workers blame political leadership at all levels, from President Donald Trump on down, for issuing confusing and contradictory messages.
"Our leaders have not been pushing that this is something really serious," said Jewell Harris Jordan, a 47-year-old registered nurse at the Kaiser Permanente Oakland Medical Center in Oakland, California. She's distraught that some Americans see mandates for face coverings as an infringement upon their rights instead of a show of solidarity with health care workers. (Kaiser Health News produces California Healthline, is not affiliated with Kaiser Permanente.)
"If you come into the hospital and you're sick, I'm going to take care of you," Jordan said. "But damn, you would think you would want to try to protect the people that are trying to keep you safe."
In Orange County, where Patel works, mask orders are particularly controversial. The county's chief health officer, Dr. Nichole Quick, resigned June 8 after being threatened for requiring residents to wearthem in public. Three days later, county officials rescinded the requirement. On June 18, a few days after Patel visited the restaurant, Gov. Gavin Newsom issued a statewide mandate.
The county's flip-flop illustrates the national conflict over masks. When the coronavirus outbreak emerged in February, officials from the U.S. Centers for Disease Control and Prevention discouraged the public from buying masks, which were needed by health care workers. It wasn't until April that federal officials began advising most everyone to wear cloth face coverings in public.
One recent study showed that masks can reduce the risk of coronavirus infection, especially in combination with physical distancing. Another study linked policies in 15 states and Washington, D.C., mandating community use of face coverings with a decline in the daily COVID-19 growth rate and estimated that as many as 450,000 cases had been prevented as of May 22.
But the use of masks has become politicized. Trump's inconsistency and nonchalance about them sowed doubt in the minds of millions who respect him, said Jordan, the Oakland nurse. That has led to "very disheartening and really disrespectful" rejection of masks.
"They truly should have just made masks mandatory throughout the country, period," said Jordan, 47. Out of fear of infecting her family with the virus, she hasn't flown to see her mother or two adult children on the East Coast during the pandemic, Jordan said.
But a mandate doesn't necessarily mean authorities have the ability or will to enforce it. In California, where the governor left enforcement up to local governments, some sheriff's departments have said it would be inappropriate to penalize mask violations. This has prompted some health care workers to make personal appeals to the public.
After the Fresno County Sheriff-Coroner's Office announced it didn't have the resources to enforce Newsom's mandate, Amy Arlund, a 45-year-old nurse at the COVID unit at the Kaiser Permanente Fresno Medical Center, took to her Facebook account to plead with friends and family about the need to wear masks.
"If I'm wrong, you wore a silly mask and you didn't like it," she posted on June 23. "If I'm right and you don't wear a mask, you better pray that all the nurses aren't already out sick or dead because people chose not to wear a mask. Please tell me my life is worth a LITTLE of your discomfort?"
To protect her family, Arlund lives in a "zone" of her house that no other member may enter. When she must interact with her 9-year-old daughter to help her with school assignments, they each wear masks and sit 3 feet apart.
Every negative interaction about masks stings in the light of her family's sacrifices, said Arlund. She cites a woman who approached her husband at a local hardware store to say he looked "ridiculous" in the N95 mask he was wearing.
"It's like mask-shaming, and we're shaming in the wrong direction," Arlund said. "He does it to protect you, you cranky hag!"
After seeing a Facebook comment alleging that face masks can cause low oxygen levels, Dr. Megan Hall decided to publish a small experiment. Hall, a pediatrician at the Conway Medical Center in Myrtle Beach, South Carolina, wore different kinds of medical masks for five minutes and then took photos of her oxygen saturation levels, as measured by her pulse oximeter. As she predicted, there was no appreciable difference in oxygen levels. She posted the photo collection on June 22, and it quickly went viral.
that about 75% of residents in her community do not wear masks in public. She doesn't feel she has the time or energy to educate people about the risk. (Courtesy of Cynthia Butler)
"Some of our officials and leaders have not taken the best precautions," said Hall, who hopes for "a change of heart" about masks among local officials and the public. South Carolina Gov. Henry McMaster has urged residents to wear face coverings in public, but he said a statewide mandate was unenforceable.
In Florida, where Gov. Ron DeSantis has resisted calls for a statewide order on masks despite a massive surge of COVID-19 cases and hospitalizations, Cynthia Butler, 62, recently asked a young man at the register of a pet store why he wasn't wearing a mask.
"His tone was more like, this whole mask thing is ridiculous," said Butler, a registered nurse at Fawcett Memorial Hospital in Port Charlotte. She didn't tell him that she had just recovered from a COVID-19 infection contracted at work. The exchange saddened her, but she hasn't the time to lecture everyone she encounters without a mask — about three-quarters of her community, Butler estimated.
"They may think you're stepping on their rights," she said. "It's not anything I want to get shot over."
For months, Patricia Merryweather-Arges, a health care expert, has fielded questions about the coronavirus pandemic from fellow Rotary Club members in the Midwest.
Recently people have wondered "Is it safe for me to go see my doctor? Should I keep that appointment with my dentist? What about that knee replacement I put on hold: Should I go ahead with that?"
These are pressing concerns as hospitals, outpatient clinics and physicians' practices have started providing elective medical procedures — services that had been suspended for several months.
Late last month, KFF reported that 48% of adults had skipped or postponed medical care because of the pandemic. Physicians are deeply concerned about the consequences, especially for people with serious illnesses or chronic medical conditions.
To feel comfortable, patients need to take stock of the precautions providers are taking. This is especially true for older adults, who are particularly vulnerable to COVID-19. Here are suggestions that can help people think through concerns and decide whether to seek elective care:
Before you go in. Give yourself at least a week to learn about your medical provider's preparations. "You want to know in advance what's expected of you and what you can expect from your providers," said Lisa McGiffert, co-founder of the Patient Safety Action Network.
Merryweather-Arges' organization, Project Patient Care, has developed a guide with recommended questions. Among them: Will I be screened for COVID-19 upon arrival? Do I need to wear a mask and gloves? Are there any restrictions on what I can bring (a laptop, books, a change of clothing)? Are the areas I'll visit cleaned and disinfected between patients?
Also ask whether patients known to have COVID are treated in the same areas you'll use. Will the medical staffers who interact with you also see these patients?
If you're getting care in a hospital, will you be tested for COVID-19 before your procedure? Is the staff being tested and, if so, under what circumstances?
Hospitals, medical clinics and physicians are offering this kind of information to varying degrees. In the New York City metropolitan area, Mount Sinai Health System has launched a comprehensive "Safety Hub" on its website featuring extensive information and videos.
Mount Sinai also encourages physicians to reach out to patients with messages tailored to their conditions. People "want to hear directly from their providers," said Karen Wish, the system's chief marketing officer.
Don't hesitate to press for more details, said Dr. Allen Kachalia, senior vice president of patient safety and quality at Johns Hopkins Medicine: "Where people get in trouble is when they're afraid to bring their concerns forward."
Seeking care. Wendy Hayum-Gross, 57, a counselor who lives in Naperville, Illinois, had been waiting since mid-March to get blood tests that would help doctors diagnose the underlying cause of a new condition, a goiter. A few weeks ago, she decided it was time.
The hospital lab she went to, operated by Edward-Elmhurst Health, told Hayum-Gross to wear a mask and gave her a number to call when she arrived in the parking lot. Outside the front door, she was met by a staffer who took her temperature, asked several screening questions and gave her hand sanitizer.
"Once I passed that, a phlebotomist met me on the other side of the door and took me to a chair that was still wet with disinfectant. She wore a mask and gloves, and there was no one else around," Hayum-Gross said. "When I saw the precautions they had put in place and the almost military precision with which they were carrying them out, I felt much better."
Marjorie Helsel DeWert, 67, of Athens, Ohio, was similarly impressed when she visited her dentist recently and noticed circular yellow signs on the floor of the office, spaced 6 feet apart, indicating where people should stand. Staffers had even put pens used to fill out paperwork in individual containers and arranged to disinfect them after use.
DeWert, a learning scientist, came up with a patient safety checklist and distributed it to family and friends. Among her questions: Can necessary forms be completed online before a medical visit? Can I wait in the car outside until called? What kind of personal protective equipment is the staff using? And is the staff being checked for symptoms daily?
Bringing a caregiver. Some medical centers are allowing caregivers to accompany patients; others are not. Be sure to ask what policies are in place.
If you feel your presence is necessary — for instance, if you want to be there for a relative who is frail or cognitively compromised — be firm but also respectful, said Ilene Corina, president of the Pulse Center for Patient Safety Education & Advocacy.
Be prepared to wear a gown, gloves and mask. "You're not there for yourself: You're there to support the health care team and the patient," said Corina, whose organization offers training to caregivers.
In Orland Park, Illinois, debi Ross, an interior designer, and her sister live with her 101-year-old mother. Eight years ago, when her mother had a tumor removed from her colon, Ross and her sister wiped down every electric socket, cord, surface and door handle in her mother's hospital room.
"Unless Mom absolutely needs [medical] care, we're not going to take her anywhere," Ross said. "But I assure you, if she does have to go see somebody, we're going to clean that place down from top to bottom, I don't care what anybody says."
If you are not allowed into a medical facility, get a phone number for the physician caring for a loved one and make sure they have your number as well, Merryweather-Arges said. Ask that you be contacted immediately if there are any complications.
Afterward. Patients leaving hospitals are fearful these days that they may have become infected with COVID-19, unwittingly. Ask your physician or a nurse what equipment you'll need to monitor yourself. Will a pulse oximeter and a thermometer be necessary? Will you need masks and gloves at home if someone is coming in to help you out with the transition? Can someone provide that equipment?
"Family caregivers need instructions that are clear," said Martin Hatlie, chief executive of Project Patient Care. "They need to know who to call 24/7 if they have a question. And they need clear guidance about infection control in the home."
If home care is being ordered, ask the agency whether they have trained staff to recognize COVID symptoms. And have home care workers been tested for COVID-19 or had symptoms?
If follow-up care is being provided via telehealth, make sure the setup works before your loved one comes home. Ask your physician's office what kind of equipment you will need, which service they use (Zoom? Skype?) and whether you can arrange a test in advance.
Finally, as you resume activities, help protect others against COVID-19 as well as yourself. When you go out into the world again, "mask up, socially distance and wash your hands," said Kachalia of Johns Hopkins. "And if you're sick or have symptoms, by all means, let your doctor's office know before you come in for a checkup."
Without medication to manage her plaque psoriasis, Jennifer Brown's face, scalp, trunk and neck periodically become covered in painful red, flaky patches so dry they crack and bleed.
She has gotten relief from medications, but they come at a high price. For a while she was on Humira, made by AbbVie, with an average retail price of roughly $8,600 for two monthly injections. When that drug stopped working for her, Brown's doctor switched her to a different drug. Today she is using another injectable, Skyrizi, also by AbbVie, which costs about $36,000 for two quarterly injections — nearly 40% more annually than Humira.
The pharmaceutical company offers an assistance program to help consumers like Brown pay their share of the drug, and that has helped her cover her copayments. However, she faces the possibility of higher drug costs under a federal rule finalized this spring by the Trump administration.
The rule, an annual directive that sets health plan standards for 2021, permits employers and insurers not to apply drug company copayment assistance toward enrollees' deductibles and out-of-pocket maximums for any drug. That means only payments made by the patients themselves would factor into the calculations to reach those spending targets and could make individuals responsible for thousands of dollars in drug costs.
Advocates for consumers with chronic conditions say the rule will make it harder for patients with conditions such as cancer and multiple sclerosis who rely on very expensive drugs to afford them.
"I understand that the administration doesn't want to encourage patients to take higher-priced drugs," said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute. "But … these are people who have HIV and other chronic conditions who take drugs that don't have generics."
Patient advocates had hoped the administration would allow employers and insurers to apply these restrictions only if a patient was taking a brand-name drug that had an appropriate generic alternative. In the rule that set standards for 2020, the administration initially seemed to take that approach. But, faced with criticism by employers and insurers, it said last summer that it would reconsider the position.
Drug company programs that provide copayment assistance to consumers have long been controversial. Employers and insurers say they encourage people to take expensive brand-name drugs instead of equally effective but cheaper generics.
Consumer advocates counter that many of the drugs consumers take for chronic conditions have no alternative. Research has shown that generics exist for about half of the drugs that offer copayment assistance.
Drugs to treat patients with hemophilia cost an average $275,000 annually, said Kollet Koulianos, senior director of payer relations at the National Hemophilia Foundation. There are no generic alternatives.
"We're not talking about $5 coupons in the Sunday paper," Koulianos said. "We're talking about high-cost specialty drugs, where they have to take this drug month in and month out for years. [Patients] just can't make the math work" without financial help.
The medication that Jennifer Brown, of Roanoke, Virginia, uses to treat her plaque psoriasis costs about $36,000 for two quarterly injections. The drugmaker offers an assistance program to help consumers pay their share of the expense, but Brown is concerned she could face higher out-of-pocket costs under a new federal rule. (Courtesy of Jennifer Brown)
The Business Group on Health, which represents large employers, supported the provisions in the final rule that allow employers to opt not to apply the value of drug company copayments for any drug toward their employees' out-of-pocket spending limits, said Steve Wojcik, vice president of public policy. About a third of large employers have such programs in place, according to the organization's annual survey.
The final rule gives employers flexibility, Wojcik said.
"If there's not a generic alternative available, a drug coupon may make sense," Wojcik said. "But it also begs the question: Why doesn't the manufacturer just lower the price at the beginning rather than issue a coupon?"
The final rule allows state laws regarding "copay accumulators," as these health plan programs are often called, to supersede the federal rule. Four states — Arizona, Illinois, Virginia and West Virginia — have passed laws that limit or prohibit their use, according to Ben Chandhok, senior director of state legislative affairs at the Arthritis Foundation. Seventeen states have considered similar bills this year, but it's unlikely any will pass given the pressure states are under because of the coronavirus pandemic, he said.
When lawmakers next meet, "they will most likely consider budget-related bills," Chandhok said.
Brown, 44, who works in auto insurance claims settlements, lives in Roanoke, Virginia. Her state is one of the few that require insurers to count payments made by drug companies on consumers' behalf toward their out-of-pocket spending limits. But her company is self-insured, meaning it pays its employees' claims directly instead of buying state-regulated insurance for that purpose. So the company isn't bound by Virginia's law and instead follows federal regulation.
A few years ago, her employer put a copay accumulator feature on her health insurance plan so the copayment assistance she received from the drug company for Humira no longer counted toward her deductible and out-of-pocket maximum spending limit for the year. That meant that once AbbVie's assistance maxed out for the year, she would be on the hook for the drug's full cost until she reached her deductible and then for cost sharing until she reached her plan's annual out-of-pocket limit.
The insurance change made her so anxious that she had a stress-related flare-up of her psoriasis, and for the first time broke out on her legs.
"I can't even describe to you how stressful that was," said Brown.
Fortunately, her doctor was able to provide Brown with drug samples, saving her from paying out-of-pocket for Humira.
There is no generic alternative for Skyrizi, the drug Brown takes now. This year, she aimed to reduce the odds that she'd be responsible for high drug payments by switching to a plan with a $2,000 deductible and a $3,000 maximum out-of-pocket spending limit. It's more expensive than her previous plan, but it reduces how much she may owe in drug copayments.
The AbbVie program will cover up to $16,000 annually in copay assistance for Skyrizi before Brown has to start paying out-of-pocket. She doesn't expect to exceed that level, so she hopes she's off the hook for this year.
But Brown acknowledges this problem isn't going away, and it's a constant source of worry.
"If I don't have the drug, my quality of life would just not be worth living," she said. "So I'll just keep accumulating debt if it comes down to that."
This article was first published on Wednesday, July 1, 2020 in Kaiser Health News.
With a tiny brush, briefly swab the vagina to collect cells. Then slide the swab into a screening kit and drop it into the mail.
Proponents believe a simple test like this, which can be done at home, may help the U.S. move closer to eradicating cervical cancer. The National Cancer Institute plans to launch a multisite study next year involving roughly 5,000 women to assess whether self-sampling at home is comparable to screening in the office by a clinician.
Nearly 14,000 Americans this year will be diagnosed with the highly preventable cancer, and more than 4,000 will die. Women who are uninsured or can't get regular medical care are more likely to miss out on lifesaving screening, said Vikrant Sahasrabuddhe, a program director in the NCI's Division of Cancer Prevention. If women could collect the vaginal and cervical cells to be tested for human papillomavirus (HPV) — the virus that causes virtually all cervical cancers — they could get screened from home, just as home-based stool samples can be used to detect colon cancer, he said.
"What we have seen is this persistent group of women who continue to get cervical cancer every year," said Sahasrabuddhe, who oversees studies involving HPV-related cancers. "And that number is really not going down."
Federal officials hope the research will fast-track a test approved by the Food and Drug Administration that could be part of screening guidelines if self-sampling is proved effective, Sahasrabuddhe said. Rather than wait for self-sampling studies to be done by the individual companies that make the HPV tests for clinicians, federal officials will team up with the companies, academic institutions and others in a public-private partnership, he explained. NCI officials, who expect to spend about $6 million in federal funds, will oversee the study's data and analysis.
"If every company goes and does their own trial, they may take years to achieve it," Sahasrabuddhe said. "We want to accelerate that process."
HPV self-sampling, already promoted in countries such as Australia and the Netherlands, is one of several approaches that U.S. cervical cancer researchers are pursuing. Another key strategy involves vaccinating adolescents against HPV, which is transmitted through sexual activity. As of 2018, nearly 54% of girls had been fully vaccinated by age 17, as had almost 49% of boys, according to the most recent federal data. The countries that have had better success in reducing cervical cancer — one analysis predicts that Australia is on track to eliminate the disease — have emphasized HPV vaccination for adolescents.
Federal officials still advise vaccinated women to get regularly screened, as the vaccine doesn't guard against all the strains that cause cervical cancer. But persuading some women to come into the office for the physical exam is sometimes a tough sell.
For some, access or cost may be an issue. Most insurance plans cover screening and there are also some public programs, but uninsured women who are unaware of them may have to pay for an office visit and test. Besides, women can't always break away from work or find child care, or they may have had "negative emotions or experiences in the past with pelvic exams," said Rachel Winer, a professor of epidemiology at the University of Washington School of Public Health who studies HPV self-sampling.
Reversing The Trend
Roughly 4 out of 5 women get regularly screened for cervical cancer, but the rates peaked around 2000 and have been on a slight decline since, according to federal data. That figure, which is based on patient self-reporting, may be optimistic. Another analysis, which looked at the medical records of 27,418 Minnesota women ages 30 to 65, found that nearly 65% were up to date as of 2016, according to the findings, published last year in the Journal of Women's Health.
"Sadly, I think our data is probably more reflective of what's happening with screening rates in our country," said Dr. Kathy MacLaughlin, a study author and researcher at Mayo Clinic in Rochester, Minnesota.
One hurdle to getting screened may be the complexity of the guidelines, MacLaughlin said. Rather than an easy-to-remember annual exam, screenings occur at intervals of longer than a year. A woman's age helps determine when the HPV test or a Pap smear, which collects cells from the cervix to look for precancerous changes, is recommended by the U.S. Preventive Services Task Force.
"It's just that challenge of, how do any of us remember to do something every three years or every five years?" MacLaughlin said. "That's hard."
At-Home Logistics
While the NCI hasn't yet settled on the precise self-sampling approach it will use, the technique generally requires the woman to insert a tiny brush into her vagina and rotate it several times to collect the cells. Then she slides the brush into a specimen container that has a preservative solution and returns the kit for HPV analysis.
According to a review of studies published in 2018 in the medical journal BMJ, the accuracy of identifying HPV was similar when the samples were collected by women at home as when collected by clinicians. A urine-based HPV test, which may prove easier for women to perform, also is being studied, said Jennifer Smith, a professor of epidemiology at the University of North Carolina's Gillings School of Global Public Health.
Before companies can pursue applications for an FDA-approved home test, self-sampling by women has to be shown comparable to detect HPV, though perhaps it may not be quite as accurate as when a clinician is involved, Sahasrabuddhe said. NCI officials are still finalizing study details. But the plan is to invite four companies that already manufacture HPV tests for clinicians to participate, Sahasrabuddhe said. The companies will pick up the tab for the cost of the tests as well as future fees related to pursuing license applications through the FDA, he said. Sahasrabuddhe expects the study results to be available by 2024, if not sooner.
Any woman who tests positive for HPV will be referred for procedures, including possibly a biopsy, to look for abnormal cells or cervical cancer, Sahasrabuddhe said.
If an FDA-approved home test is developed, it's crucial that uninsured women and others who don't have easy access to medical care be able to get those procedures, Smith said.
"You just don't send random kits out to people's homes," Smith said, "and not ensure that they have someone to talk to about the results and are going to be able to be integrated into a follow-up system."
Carmen Quintero works an early shift as a supervisor at a 3M distribution warehouse that ships N95 masks to a nation under siege from the coronavirus. On March 23, she had developed a severe cough, and her voice, usually quick and enthusiastic, was barely a whisper.
A human resources staff member told Quintero she needed to go home.
“They told me I couldn’t come back until I was tested,” said Quintero, who was also told that she would need to document that she didn’t have the virus.
Her primary care doctor directed her to the nearest emergency room for testing because the practice had no coronavirus tests.
The Corona Regional Medical Center is just around the corner from her house in Corona, California, and there a nurse tested her breathing and gave her a chest X-ray. But the hospital didn’t have any tests either, and the nurse told her to go to Riverside County’s public health department. There, a public health worker gave her an 800 number to call to schedule a test. The earliest the county could test her was April 7, more than two weeks later.
At the hospital, Quintero got a doctor’s note saying she should stay home from work for a week, and she was told to behave as if she had COVID-19, isolating herself from vulnerable household members. That was difficult — Quintero lives with her grandmother and her girlfriend’s parents — but she managed. No one else in her home got sick, and by the time April 7 came, she felt better and decided not to get the coronavirus test.
Then the bill came.
The Patient: Carmen Quintero, 35, a supervisor at a 3M distribution warehouse who lives in Corona, California. She has an Anthem Blue Cross health insurance plan through her job with a $3,500 annual deductible.
Total Bill: Corona Regional Medical Center billed Quintero $1,010, and Corona Regional Emergency Medical Associates billed an additional $830 for physician services. She also paid $50 at Walgreens to fill a prescription for an inhaler.
Service Provider: Corona Regional Medical Center, a for-profit hospital owned by Universal Health Services, a company based in King of Prussia, Pennsylvania, which is one of the largest health care management companies in the nation. The hospital contracts with Corona Regional Emergency Medical Associates, part of Emergent Medical Associates.
Medical Service: Quintero was evaluated in the emergency room for symptoms consistent with COVID-19: a wracking cough and difficulty breathing. She had a chest X-ray and a breathing treatment and was prescribed an inhaler.
What Gives: On that day in late March when her body shook from coughing, Quintero’s immediate worry was infecting her family, especially her girlfriend’s parents, both over 65, and her 84-year-old grandmother.
“If something was to happen to them, I don’t know if I would have been able to live with it,” said Quintero.
Quintero wanted to isolate in a hotel, but she could hardly afford to for the week that she stayed home. She had only three paid sick days and was forced to take vacation time until her symptoms subsided and she was allowed back at work. At the time, few places provided publicly funded hotel rooms for sick people to isolate, and Quintero was not offered any help.
For her medical care, Quintero knew she had a high-deductible plan yet felt she had no choice but to follow her doctor’s advice and go to the nearest emergency room to get tested. She assumed she would get the test and not have to pay. Congress had passed the CARES Act just the week before, with its headlines saying coronavirus testing would be free.
That legislation turned out to be riddled with loopholes, especially for people like Quintero who needed and wanted a coronavirus test but couldn’t get one early in the pandemic.
“I just didn’t think it was fair because I went in there to get tested,” she said.
Some insurance companies are voluntarily reducing copayments for COVID-related emergency room visits. Quintero said her insurer, Anthem Blue Cross, would not reduce her bill. Anthem would not discuss the case until Quintero signed its own privacy waiver; it would not accept a signed standard waiver KHN uses. The hospital would not discuss the bill with a reporter unless Quintero could also be on the phone, something that has yet to be arranged around Quintero’s workday, which begins at 4 a.m. and ends at 3:30 p.m.
Three states have gone further than Congress to waive cost sharing for testing and diagnosis of pneumonia and influenza, given these illnesses are often mistaken for COVID-19. California is not one of them, and because Quintero’s employer is self-insured — the company pays for health services directly from its own funds — it is exempt from state directives anyway. The U.S. Department of Labor regulates all self-funded insurance plans. In 2019, nearly 2 in 3 covered workers were in these types of plans.
Resolution: As lockdown restrictions ease and coronavirus cases rise around the country, public health officials say quickly isolating sick people before the virus spreads through families is essential.
But isolation efforts have gotten little attention in the U.S. Nearly all local health departments, including Riverside County, where Quintero lives, now have these programs, according to the National Association of County and City Health Officials. Many were designed to shelter people experiencing homelessness but can be used to isolate others.
Raymond Niaura, interim chairman of the Department of Epidemiology at New York University, said these programs are used inconsistently and have been poorly promoted to the public.
“No one has done this before and a lot of what’s happening is that people are making it up as they go along,” said Niaura. “We’ve just never been in a circumstance like this.”
Quintero still worries about bringing the virus home to her family and fears being in the same room with her grandmother. Quintero returns from work every day now, puts her clothes in a separate hamper and diligently washes her hands before she interacts with anyone.
The bills have been another constant worry. Quintero called the hospital and her insurance company and complained that she should not have to pay since she was seeking a test on her doctor’s orders. Neither budged, and the bills labeled “payment reminders” soon became “final notices.” She reluctantly agreed to pay $100 a month toward her balance — $50 to the hospital and $50 to the doctors.
“None of them wanted to work with me,” Quintero said. “I just have to give the first payment on each bill so they wouldn’t send me to collections.”
The Takeaway: If you suspect you have COVID-19 and need to isolate to protect vulnerable members of your household, call your local public health department. Most counties have isolation and quarantine programs, but these resources are not well known. You may be placed in a hotel, recreational vehicle or other type of housing while you wait out the infection period. You do not need to have a positive COVID test to qualify for these programs and can use these programs while you await your test result. But this is an area in which public health officials repeatedly offer clear guidance — 14 days of isolation — which most people find impossible to follow.
At this point in the pandemic, tests are more widely available and federal law is very clearly on your side: You should not be charged any cost sharing for a coronavirus test.
Be wary, though, if your doctor directs you to the emergency room for a COVID test, because any additional care you get there could come at a high price. Ask if there are any other testing sites available.
If you do find yourself with a big bill related to suspected COVID, push beyond a telephone call with your insurance company and file a formal appeal. If you feel comfortable, ask your employer’s human resources staff to argue on your behalf. Then, call the help line for your state insurance commissioner and file a separate appeal. Press insurers — and big companies that offer self-insured plans — to follow the spirit of the law, even if the letter of the law seems to let them off the hook.
Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!