We wanted to know whether there was any truth to the idea that the CDC was removing its test because it is faulty and cannot tell one virus from another. So we consulted several laboratory testing experts.
This article was published on Friday, July 30, 2021 in Kaiser Health News.
Posts circulating on Facebook and Instagram claim the Centers for Disease Control and Prevention will stop using its covid-19 test because it cannot differentiate between the covid virus and flu viruses.
“CDC has just announced they will revoke the emergency use authorization of the RT-PCR tests first introduced in 2/20,” reads a July 25 post, which goes on to quote from the agency’s lab directive: “CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS CoV-2 and influenza viruses.” It continues: “Translation: They’ve been adding flu cases to Covid cases when using that test.”
Mike Huckabee, a former Fox News host who was also a Republican presidential candidate and governor of Arkansas, similarly claimed on Facebook that the CDC test cannot tell the difference between coronaviruses and flu viruses.
A July 24 Instagram post went further: “The FDA announced today that the CDC PCR test has failed its full review. Emergency Use Authorization has been REVOKED.”
The posts were flagged as part of Facebook’s efforts to combat false news and misinformation on its news feed. (Read more about PolitiFact’s partnership with Facebook.)
We wanted to know whether there was any truth to the idea that the CDC was removing its test because it is faulty and cannot tell one virus from another. So we consulted several laboratory testing experts.
It is standard practice for the Food and Drug Administration to issue temporary emergency use authorizations for tests and other medical products that have not yet undergone the FDA’s full approval process but need to be used in an emergency to diagnose, treat or prevent serious diseases.
The FDA issued the EUA for the CDC’s 2019-nCoV RT-PCR in February 2020. At that time, no other tests were available in the U.S. to determine whether someone had covid.
But it’s important to remember that what the CDC developed and submitted for its EUA request was not a tangible product but rather a protocol for how to test for covid, said Susan Whittier, a professor of pathology and cell biology at Columbia University Irving Medical Center. That means the CDC wrote out directions specifying which reagents were needed to test the laboratory samples for the presence of the covid virus. The CDC does not distribute covid tests.
“It’s not like they have a test that laboratories can purchase. We borrow their protocol and use the reagents that they say,” said Whittier, who recently retired as director of the clinical microbiology lab at Columbia. So withdrawing the EUA request just “means that protocol will no longer be available.”
In the lab alert, the CDC said it was withdrawing the EUA request because, rather than testing only for the covid virus, it wants labs to test people for multiple viruses simultaneously, using what is known as a “multiplexed method.” The CDC’s 2019-nCoV RT-PCR panel tests only for the covid virus.
“Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season,” noted the alert regarding the multiplexed method.
Dr. Christopher Polage, an associate professor of pathology at Duke University, said his take on the CDC’s message is that, because flu season is on the horizon, a patient might come in with respiratory symptoms that could be attributed to either covid or the flu. Laboratories need to start testing for both covid and various flu viruses.
But the lab alert does not mean the CDC’s test cannot differentiate between covid and the flu.
In fact, the CDC’s 2019-nCoV RT-PCR test was developed to look for the presence of a nucleic acid found only in the covid virus, said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories.
“It is not remotely accurate that the CDC test doesn’t differentiate between flu and SARS-CoV-2. It doesn’t detect influenza. It only detects SARS-CoV-2,” said Wroblewski. “If flu and covid are both circulating, you would be able to detect only SARS-CoV-2 and not flu.”
How the CDC’s 2019-nCoV RT-PCR test (or any other PCR test) works, Wroblewski said, is that primers, which are little bits of a genetic material, are used to identify specific viruses. In this case, the primer is built to identify a nucleic acid found only in the covid virus.
If the covid virus is present in the sample, the primer will attach to the virus’s nucleic acid and make many copies of it. A chemical in the test will then fluoresce, which the polymerase chain reaction, or PCR, machine will interpret as a positive result. If the covid virus is not present, the primer will have nothing to attach to.
When asked about the CDC withdrawing its EUA request, FDA spokesperson Jim McKinney told us PCR tests are considered the “gold standard” for covid diagnosis. He pointed us to data that illustrated the specificity and exclusivity of the CDC’s test. That data shows test results came back negative for samples that contained similar viruses, including different types of flu and other coronaviruses.
All of this means the CDC’s 2019-nCoV RT-PCR test would not erroneously detect flu viruses. Thus, the Facebook posts’ assertions that the test cannot differentiate between covid and flu are demonstrably false.
Even though the CDC is withdrawing its EUA request for this specific test, Wroblewski pointed out, it still has an EUA for a second PCR test, a multiplex one that simultaneously tests for covid and influenza types A and B.
The FDA has issued EUAs to many laboratories and testing companies for hundreds of covid tests that use the same PCR technology the CDC uses — which experts said essentially made the CDC testing protocol moot, since similar tests will still be available.
So, while it is true the CDC is withdrawing its EUA request for its test that tests solely for covid, it is not for the reasons given by the Facebook posts. The assertion that covid case counts were inflated because the test was faulty and was counting flu cases as covid cases is false.
“They didn’t withdraw the EUA because the test wasn’t working,” said Whittier. “They just wanted people to look for other viruses as well.”
Polage agreed.
“The CDC is pulling their test ‘off the market’ as a gesture to encourage labs to use tests that include reagents (primers and probes) for both SARS-CoV-2 and Influenza so providers, labs, states, and CDC will have better data this fall and winter to estimate how much of clinical influenza-like illness is due to SARS-CoV-2 and how much is due to seasonal influenza,” Polage said in an email.
Our Ruling
Social media posts claimed the CDC was revoking its emergency use authorization request for its covid test because it couldn’t differentiate between the covid virus and flu viruses. While the CDC is withdrawing its EUA request for the 2019-nCoV RT-PCR test, it is not because the test is faulty.
Rather, it’s because the agency is concerned that, with flu season approaching, patients with respiratory illness symptoms should be screened for both the flu and covid. The patients shouldn’t be tested for covid alone, because flu cases might be missed.
The statements made in these Facebook posts are not accurate. We rate this claim False.
SACRAMENTO, Calif. — Californians upset with Gov. Gavin Newsom’s pandemic rules — which shuttered businesses, kept schoolkids at home and mandated masks — helped fuel the September recall election that could spell the end of his political career.
But among the allies rushing to Newsom’s defense are doctors, nurses, dentists and other health care interests who credit those pandemic measures for protecting them as front-line workers and saving the lives of countless Californians.
Their unions and trade associations have written checks totaling more than $4.8 million as of 10 a.m. Friday to keep the first-term Democrat in office, according to a KHN analysis of campaign finance filings with the California secretary of state’s office.
Even before covid-19, Newsom had been a steadfast health care advocate and ally, adopting policies that expanded health benefits and coverage to hundreds of thousands of Californians — and lined the pockets of the industry in the process.
“He’s done so much so broadly within the health care sector in California to the benefit of patients and providers of all sorts,” said Andrew Kelly, an assistant professor in the Department of Health Sciences at California State University-East Bay. “That is good for the health care business, as well as our community — improving access to care and outcomes.”
Californians will decide Sept. 14 whether to recall Newsom on a ballot that also asks them to pick his replacement from a list of 46 candidates. If more than 50% of voters choose “yes” to recall Newsom, the candidate who wins the most votes will replace him.
The recall election offers Republicans in blue California — where Democrats hold all statewide offices and control the legislature — their best shot at winning the governor’s office. The GOP candidates with the highest name recognition are businessman John Cox, conservative talk show host Larry Elder, former San Diego Mayor Kevin Faulconer, reality TV star and former Olympian Caitlyn Jenner, suburban Sacramento state Assembly member Kevin Kiley and former congressman Doug Ose.
A poll released Tuesday by the University of California-Berkeley Institute of Governmental Studies found that 47% of likely voters said they favor recalling Newsom, compared with 50% who said they oppose recalling the governor.
Newsom’s supporters have given more than $40 million to fight the recall, compared with nearly $12 million by recall backers, which includes $5 million from Cox for his own campaign.
The health care contributions to fight the recall make up a fraction of the total, but they’re far-reaching: Health care worker unions, dentists, physicians, pharmacists, insurance companies, at least one hospital and others have made big contributions to independent campaign committees created by Newsom’s supporters that can accept unlimited donations.
The health care group that has given the most — $2.25 million — is the union representing California’s nursing home workers and in-home caregivers, Service Employees International Union 2015. Other contributions included $150,000 from the Union of American Physicians and Dentists (whose members include doctors and dentists employed by the state and some counties) and $500,000 from the California Dental Association. These groups either declined telephone interviews or did not respond to requests for comment.
In an emailed statement, SEIU 2015 did not address its sizable contributions but said it intended to mobilize “our mostly black, brown and immigrant caregivers who have been on the front lines of this pandemic to make their voices heard as we go door-to-door, over the phone and online encouraging a vote against the recall.”
An emailed statement from the California Dental Association said its political action committee “puts a great deal of consideration into supporting candidates who are interested in solving the challenges experienced by the dental profession and their patients.”
Republican candidates haven’t received any big donations — defined by the California Fair Political Practices Commission as $1,000 or more — from organized health care groups, which gubernatorial hopeful Kiley said shows just how cozy the governor is with the industry.
“You have vested interests that do whatever it takes to get the governor to do what they want,” said Kiley, one of two Assembly members who sued Newsom last year for using his emergency powers during a pandemic. “He’s taking money from all of them.”
The diverse field of health care interests defending Newsom aren’t always on the same side politically. In fact, they’re often at odds.
But if you’re in health care or public health, the prospect of Newsom being booted from office is worrisome, especially if you want the state to continue combating the pandemic, said Mark Peterson, a professor of public policy and political science at UCLA.
“I don’t think anyone who would be replacing the governor in the recall would be anywhere near as aggressive and might actually put in reverse the public health actions that have been taken,” Peterson said.
Sal Rosselli, president of the National Union of Healthcare Workers, which represents nurses, drug rehab counselors, pharmacists and others, said his union’s 15,000 members are grateful for Newsom’s leadership in the pandemic — citing his first-in-the-nation statewide stay-at-home order, his directive to hospitals last winter to test workers for covid, and other workplace orders that protected essential workers.
“These are all examples of real leadership,” Rosselli said.
In January, the union created a ballot committee to urge Californians not to sign the recall petition — chipping in just over $100,000 of its own money and collecting $10,000 apiece from state Senate leader Toni Atkins and Assembly Speaker Anthony Rendon, among others, to help pay for political ads praising Newsom’s leadership during the pandemic.
Nathan Click, a Newsom campaign spokesperson, did not address the money Newsom has received from the health care industry, but said Californians have a clear choice for governor.
“On one side, you have a governor who has expanded health care for Californians and fought to lower health care costs for families,” Click said via email. “On the other side are a bunch of Trump lackeys who want to repeal Obamacare and take away health care from those who need it most.”
When Newsom campaigned for governor in 2018, he called for a government-backed, single-payer health system at a time when the Trump administration and many Republican lawmakers were trying to dismantle the Affordable Care Act.
He hasn’t delivered on his single-payer pledge, citing insurmountable federal hurdles. But he has signed legislation and advocated for policies that insured more Californians or boosted their benefits, policies that also enrich insurers and providers by bringing them more patients.
For instance, low-income undocumented immigrants ages 19 to 25 became eligible for full benefits under Medi-Cal, California’s Medicaid program for poor residents, last year. Next year, people 50 and older will become eligible regardless of their immigration status.
For the more than 13 million Californians already in the program, Newsom and legislators agreed last year to restore dental, vision and other optional health care benefits that had been cut during the Great Recession. And they boosted the rates the program pays physicians and dentists.
Qualified Californians can also tap into state subsidies to reduce the cost of health insurance premiums sold through Covered California, a benefit approved by Newsom in 2019.
The recall has handed the unions an opportunity to pressure Newsom to act on his single-payer pledge, arguing that the pandemic has laid bare deadly disparities in health care. For example, Latinos in California not only were exposed to covid at much higher rates but also died at 1.5 times the rate of white Californians, according to researchers at Stanford University.
“We trust that Gavin Newsom is the person to lead” on single-payer, said Rosselli, who has known Newsom since he got into politics nearly 20 years ago. “To make California the first state in the nation as an example for the rest of the country on ending these inequities in health care.”
Methodology
Gov. Gavin Newsom is facing a recall election Sept. 14. To find out which health care interests are contributing for and against the recall effort, KHN analyzed campaign finance reports filed with the California secretary of state’s office through 10 a.m. Friday, July 30. Each candidate and campaign committee participating in the recall is required to report how much money they’ve raised and spent. Any donation of $1,000 or more must be reported within 24 hours.
We downloaded and analyzed campaign records from two committees created to support the recall, committees run by the leading Republican candidates, and five committees created to oppose the recall.
The message from Big Bend Regional Medical Center was stark: The only hospital in a sparsely populated region of far West Texas notified local physicians last month that because of a nursing shortage its labor and delivery unit needed to temporarily close its doors and that women in labor should instead be sent to the next closest hospital — an hour’s drive away.
That is, unless the baby’s arrival appears imminent, and the hospital’s unit is shut down at that point. In that case, a woman would deliver in the emergency room, said Dr. Jim Luecke, who has practiced 30-plus years in the area.
But that can be a tough call, he added. Luecke described his concerns for two patients, both nearing their due date, who had previously given birth, boosting the chance of a faster delivery. “They can go from 4 centimeters dilated to completely dilated within a few minutes,” said the family physician, who estimates he’s delivered 3,000 babies.
Some pregnant women already travel an hour and a half or longer to reach the 25-bed Big Bend Regional in Alpine, said Dr. Adrian Billings, another family physician who delivers babies there. “Now to divert these ambulances at least another 60 miles away, it’s asking for more deliveries to happen en route to the hospital, and potentially poor maternal or neonatal outcomes.”
Luecke can’t recall a time when the obstetrics unit at Big Bend Regional has closed.
But it’s happening in other parts of the state: Ten rural hospitals have stopped delivering babies in the past five years or so, leaving 65 out of 157 that still do, according to the Texas Organization of Rural & Community Hospitals.
Hiring and retaining rural nurses has become even more challenging amid the pandemic as nurses have been recruited to work in urban covid-19 hot spots and sometimes don’t return to their communities, said John Henderson, chief executive officer at TORCH. More recently, some Texas hospitals have offered signing bonuses of $10,000 or more as they jockey for nurses, he said. “Covid has caused a resetting of market rates and a reshuffling of nurse staffing.”
The circumstances at Big Bend Regional, which serves a 12,000-square-mile area (about the size of Maryland), illustrates the ripple effects of potentially losing obstetric services across a broader region. The hospital, owned by Quorum Health Corp., serves a swath that extends southwest to the Mexican border and includes Big Bend National Park as well as the communities of Presidio and Candelaria. The nearest hospital, the 25-bed Pecos County Memorial in Fort Stockton, is 68 miles northeast of Alpine.
As of late July, Big Bend Regional’s obstetrics services remained in flux, with the unit closed for four- and five-day stretches, said Billings. Physicians have been told that the unit would typically remain open only Monday morning through Thursday morning of each week until more nurses arrive, he said.
The staffing crisis highlights the need for more state and national efforts to train rural nurses and other clinicians, Billings added. “The big concern that I have is that, if we don’t fix this, this could be the beginning of a rural maternity care desert out here in the Big Bend.”
The hospital, which delivered 136 babies last year, said it is “working feverishly to ensure adequate staffing levels in the coming weeks,” recruiting to fill 10 nursing positions in the labor and delivery unit, according to a statement to KHN. “When our hospital is on diversion for elective OB patients, we communicate in advance with nearby emergency transport services and acute care providers to ensure continuity of care,” the statement said.
Kelly Jones of Alpine, who worried she was having contractions, couldn’t get anyone to pick up the phone for a few hours at Big Bend’s unit in mid-July. She decided to drop off her son at a friend’s house and head to the hospital.
Jones, who is nearly full term, knew the unit had been closed a few days earlier that month but didn’t realize that closures were still occurring. “I went in and said, ‘I think I’m in labor.’ They were like, ‘Well, you can’t go into labor and delivery because they’re closed. So we’re going to take you to the ER.’” In the end, medical personnel determined she wasn’t going to deliver that day and she went home.
Since the hospital first alerted doctors last month, the unit has been on diversion July 5-9, July 14-18 and then again July 22 until Sunday, July 25, according to Billings. Efforts were being made to recruit nurses from Odessa, 150 miles away, to fill in, but the outcome was uncertain, Billings said.
Luecke scheduled an induction for one patient for July 26, when her pregnancy would be at 39 weeks — a week short of full term — and the unit was scheduled to be open. “We are trying to induce them [women] on the days that they [the hospital’s unit] are open,” he said.
Jones, who is being cared for by another physician, is scheduled for induction Aug. 2, at 39 weeks. “For a while, I was not sleeping. I was really stressed. I was panicking about every scenario,” said the 30-year-old, whose pregnancy was initially considered high risk because her son had been born prematurely.
But Jones felt better once her induction date was set. And what if the baby arrives sooner and the unit is closed? She’s been told to go to the ER, to be taken from there by ambulance to the local airport and flown to Fort Stockton.
Malynda Richardson, director of emergency medical services for the town of Presidio, which sits along the Mexican border about 90 miles from Alpine, said its first responders transport more than two dozen women with pregnancy-related issues each year, most of them in labor, including an average of two who deliver en route. First responders, including paramedics, are not typically trained to assess a woman’s cervix for dilation, making it more difficult to gauge imminent delivery, she said.
Also, when responders drive an additional two to three hours round trip to reach Fort Stockton, that affects the Presidio community, which can reliably staff only one ambulance, Richardson said. “What happens when we do have that transport [of a woman in labor] and have to go to Fort Stockton and then we have somebody else down here having a heart attack and we don’t have an ambulance available?”
Rural obstetrics units require far more nurses than doctors to remain open, so diverting women elsewhere in the short term makes sense, said Dr. Tony Ogburn, who chairs the department of obstetrics and gynecology at the University of Texas Rio Grande Valley School of Medicine. “If you don’t have trained nurses there, it doesn’t matter if you have a physician that can do a C-section or do a delivery; you can’t take care of those patients safely,” he said.
Registered nurses who work in labor and delivery have completed specialized training, such as how to read a fetal heart monitor, so a nurse from the ER or another hospital unit can’t easily step in, Billings said. “It’s kind of like having a small football team or a small soccer team and not being able to pull from the bench,” he said.
Billings said he’s reached out to Dr. Michael Galloway, who chairs the department of obstetrics and gynecology at Texas Tech University Health Sciences Center in Odessa and has been helping coordinate efforts to recruit nurses from that city. But even if Odessa nurses agree to pick up some shifts at Big Bend Regional, they are likely a stopgap solution, said Billings, who questions how long they’d be willing to work so far away from home.
Luecke believes Big Bend Regional administrators are doing everything they can to improve nurse staffing. But, like Billings, he’s worried that these July temporary closures could become longer-term.
“We are hoping August will be a different situation,” Luecke said. “But it’s pretty iffy right now.”
Studies have found that older adults with a broad array of "weak" as well as "close" ties enjoy better physical and psychological well-being and live longer than people with narrower, less diverse social networks.
This article was published on Monday, August 2, 2021 in Kaiser Health News.
In May, Vincent Keenan traveled from Chicago to Charlottesville, Virginia, for a wedding — his first trip out of town since the start of the pandemic.
"Hi there!" he called out to customers at a gas station where he'd stopped on his way to the airport. "How's your day going?" he said he asked the Transportation Security Administration agent who checked his ID. "Isn't this wonderful?" he exclaimed to guests at the wedding, most of whom were strangers.
"I was striking up conversations with people I didn't know everywhere I went," said Keenan, 65, who retired in December as chief executive officer of the Illinois Academy of Family Physicians. "Even if they just grunted at me, it was a great day."
It wasn't only close friends Keenan missed seeing during 15 months of staying home and trying to avoid COVID-19. It was also dozens of casual acquaintances and people he ran into at social events, restaurants, church and other venues.
These relationships with people we hardly know or know only superficially are called "weak ties" — a broad and amorphous group that can include anyone from your neighbors or your pharmacist to members of your book group or fellow volunteers at a school.
Like Keenan, who admitted he's an unabashed extrovert, many older adults are renewing these connections with pleasure after losing touch during the pandemic.
Casual relationships have several benefits, according to researchers who've studied them. These ties can cultivate a sense of belonging, provide bursts of positive energy, motivate us to engage in activities, and expose us to new information and opportunities — all without the emotional challenges that often attend close relationships with family and friends.
Multiple studies have found that older adults with a broad array of "weak" as well as "close" ties enjoy better physical and psychological well-being and live longer than people with narrower, less diverse social networks. Also, older adults with broad, diverse social networks have more opportunities to develop new relationships when cherished friends or family members move away or die.
"Feeling connected to other people, not just the people who are closest to you, turns out to be incredibly important," said Gillian Sandstrom, a senior lecturer in the department of psychology at the University of Essex in England.
Sandstrom's research has found that people who talk to more acquaintances daily tend to be happier than people who have fewer of these interactions. Even talking to strangers makes people feel less lonely and more trusting, she has discovered.
Claire Lomax, 76, of Oakland, California, who's unmarried, has made a practice of chatting with strangers all her life. Among her greatest pleasures in recent years was volunteering at the Oakland Police Department, where she would ask patrol officers about their families or what was happening at the station.
"I never wanted a man of my own, but I like to be around them," she explained. "So, I got to have my guy buzz without any complications, and I felt recognized and appreciated," Lomax told me. Since becoming fully vaccinated, she's volunteering in person at the police stations again — a deep source of satisfaction.
Even people who describe themselves as introverts enjoy the positivity that casual interactions can engender.
"In fact, people are more likely to have purely positive experiences with weak ties" because emotional complications are absent, said Katherine Fiori, a prominent researcher and chair of the psychology department at Adelphi University in Garden City, New York.
Lynn Eggers, 75, a retired psychologist in Minneapolis, loved going to coffee shops and the gym before COVID hit. "In both places, you can be in a group and alone," she told me. "You can choose to talk to someone or not. But you feel you're part of the community."
At a light-rail station, Eggers would strike up conversations with strangers: two police officers who told her about growing up in Somalia, a working-class Texan whose daughter won a scholarship to Harvard, a young Vietnamese woman whose parents worried she was abandoning her culture.
When Eggers stopped taking public transportation for fear of COVID, she missed "getting these glimpses into other ways of seeing the world." Instead, she started chatting with neighbors in daily walks around her neighborhood — another way to feel connected.
Many people may have found that neighbors, mail carriers and delivery people became more important during the pandemic — simply because they were around when others were not, said Karen Fingerman, a professor of human ecology at the University of Texas-Austin. As pandemic restrictions lift, "the key is to get out in daily life again" and reengage with a variety of people and activities, she recommended.
Helen Bartos, 69, a retired clinical psychologist, lives in a condominium community in Rochester, New York. "With COVID, a whole group of us started getting together outside," she told me. "We'd bring out chairs and drinks, wear masks, and sit around and talk. It was very bonding. All of these people are neighbors; now I would call some of them friends."
Ellie Mixter-Keller, 66, of Milwaukee, turned to social gatherings sponsored by the activity group Meetup six years ago after a divorce disrupted her life. "It was my salvation. It exposed me to a bunch of new people who I didn't have to date or have to dinner," she said. Now that she's fully vaccinated, she's busy almost every night of the week attending Meetup events and informal get-togethers arranged by people she's met.
In some cases, varying views of COVID vaccines have made casual interactions more difficult. Patty Beemer, 61, of Hermosa Beach, California, used to go swing-dancing two or three times a week before the pandemic. "It'd be 20 seconds of chitchat and just dance" before all those events were canceled, she said.
In the past several months, however, the swing-dance community in and around Los Angeles has split, with some events requiring proof of vaccination and others open to everyone.
"Before, everyone danced with everyone, without really thinking about it. Now, I don't know if it's going to be like that. I'm not sure how much mixing is going to happen," Beemer said. "And that sense of shared humanity, which is so meaningful to all of us, may be harder to find."
We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.
Bryan Keller's health insurance covered much of the cost of his visit to the CityMD clinic. But it didn't cover the physician who stitched his forehead.
This article was published on Monday, August 2, 2021 in Kaiser Health News.
It was a Sunday morning in late November when Bryan Keller hopped on a bike for a routine ride to pick up his groceries, cruising with ease in a relatively empty New York City.
The surprises came fast and hard: a fall that sent his head into the pavement and left him bleeding profusely and in shock, a trip to an urgent care clinic for five stitches and then a $1,039.50 bill.
Keller's health insurance covered much of the cost of his visit to the CityMD clinic on Manhattan's Lower East Side. But it didn't cover the physician who arrived to stitch his forehead ― an out-of-network plastic surgeon with a Park Avenue office.
"The people at CityMD just said [this] sort of thing is covered as part of an emergency procedure," said Keller, a regular cyclist who's lived in New York City for three decades. Even in post-accident "delirium," he said, he asked several times whether the stitches would be covered by his health insurance because it struck him as unusual that a plastic surgeon would do them.
"It really irked me that, it's this classic thing you hear in this country all the time," Keller said. "When you do all the right things, ask all the right questions and you're still hit with a large bill because of some weird technicality that there's absolutely no way for you to understand when you're in the moment."
Under a law Congress passed last year, many surprise medical bills will be banned starting in January. Patients with private insurance will be protected against unexpected charges for emergency out-of-network care, for treatment by out-of-network providers at in-network facilities and for transport in an air ambulance. But one gray area: visits to urgent care clinics, which have proliferated in recent years as patients seek speed and convenience over waiting hours at an emergency room or weeks to get a regular doctor's appointment. There are roughly 10,500 urgent care centers in the U.S., according to the Urgent Care Association, which lobbies on their behalf.
Urgent care clinics were not explicitly addressed in the No Surprises Act, but Keller's experience underscores patients' predicament ― insurers often try to steer patients to urgent care and away from costly emergency rooms, but individuals could still get hit with large bills in the process. The Biden administration has expressed an interest in prohibiting surprise bills in those clinics, which may treat serious conditions but not life-threatening injuries and illnesses.
In July, several federal agencies issued interim regulations that largely would not protect patients from surprise urgent care bills. Regulation varies significantly across states, and data is scarce on how common surprise bills are in those facilities. Before the surprise billing rules are finalized, the Department of Health and Human Services and three other federal agencies have asked for information on issues such as the frequency of such bills at urgent care facilities and how health insurers contract with the clinics.
The current regulatory gap, if left untouched before the new law takes effect in January, is one that healthcare experts say could leave patients at risk.
"There's a real interesting question about whether it should apply to the extent that people perceive these as places to go for an emergency," said Jack Hoadley, research professor emeritus for Georgetown University's McCourt School of Public Policy.
CityMD, which was founded by doctors in 2010 and merged with the large medical practice Summit Medical Group in 2019, operates a massive chain of urgent care clinics in New York and New Jersey. Most of its physicians are emergency doctors. The combined enterprise created Summit Health, which is backed by private equity with investments from well-known firms Warburg Pincus ― which acquired CityMD in 2017 ― and Consonance Capital Partners.
Matt Gove, chief marketing officer of Summit Health, confirmed that the plastic surgeon who treated Keller ― Dr. Michael Wolfeld ― has an agreement with the company that allows him to see patients at certain CityMD clinics. Though he was unable to comment on the specifics of Keller's situation, he said, CityMD's "normal procedure" is to "make the patient aware that this is available to them and that they can then make the choice as to whether or not it's important to them to be seen by a plastic surgeon."
"This is a patient choice," Gove said. "We certainly don't require that a patient be seen by Dr. Wolfeld or any other provider."
But Keller said it was never put to him as an option. "It was framed to me as 'This is how we do things,'" he said. "In order to have a preference I would have to know that there is an alternative." Wolfeld did not respond to a request for comment.
"It really irked me that, it's this classic
Last month the Biden administration proposed prohibiting surprise bills at urgent care centers licensed to perform emergency procedures, essentially treating them as free-standing emergency rooms. Some states, like Arizona, allow urgent care centers to provide emergency services, but they then are considered free-standing ERs, a spokesperson for the state Department of Health Services said. But urgent care centers aren't licensed as healthcare facilities in most states, let alone encouraged to provide emergency services, according to healthcare advocates that have tracked the issue and have pushed for greater government oversight of the industry.
New York, where Keller lives, doesn't consistently regulate urgent care providers, requiring licenses for some companies but not for CityMD clinics.
Regardless of what's prescribed in state regulations, what's considered an "emergency" versus "urgent" can vary by patient. That potentially creates confusion about whether patients would be protected from certain kinds of out-of-network bills if they show up at an urgent care facility for an acute illness or injury.
KHN also found that the urgent care clinic where Keller was treated describes several of its services as emergency care even though many are not meant to treat emergency conditions as envisioned in federal law. For example, the clinic characterizes physical exams, flu shots and vaccinations as emergency medical services. Under federal law, an emergency medical condition is defined as one where the absence of immediate medical attention could seriously jeopardize a patient's health.
Summit Health spokesperson Gove said the use of the term "emergency" is meant to be "patient-facing and patient-centric, and not having to do with miscategorizing or misrepresenting the nature of the services we provide."
The provider is "just making it clear to people that when you have something you need done quickly, which you might call personally an emergency, we're here to do that." CityMD has never marketed itself as an emergency room designed to treat all emergency conditions, Gove said.
Lou Ellen Horwitz, CEO of the Urgent Care Association, said urgent care clinics are akin to private doctor practices rather than an emergency room or hospital facility that would be subject to broad bans on surprising billing. She said that, even as urgent care clinics grow more common, there's "no data" to suggest consumer confusion about what they treat.
The association would oppose any federal push to classify these clinics as something akin to independent emergency departments, Horwitz said. Indeed, she said, such a move "contradicts" their very purpose: to treat non-life-threatening injuries and illnesses.
"The standard practice of the industry as well is that we don't hold ourselves out to be emergency departments," she said. "The likelihood of this being misunderstood is very low."
Nationwide, under the Biden administration's interim regulations, patients needing care for nonemergencies will not be protected if treated by an out-of-network provider at an in-network urgent care facility, according to healthcare experts. "You don't have protections if it turns out the doctor or the physician assistant was out of network," Hoadley said.
A March report from Community Catalyst, a Boston-based healthcare advocacy organization focused on consumer issues, and the National Health Law Program, a civil rights advocacy group, found that fewer than 10 states issue facility licenses for urgent care clinics. Those licenses give state officials greater leeway to set standards for care, staffing levels, inspections or price transparency, but could also make care more expensive by increasing providers' expenses.
Without being licensed as a healthcare facility ― something that exists for hospitals, ambulatory surgery centers and critical access hospitals ― urgent care clinics are generally treated as private physician practices subject to less regulation. "They're really flying under the radar now in many cases," said Lois Uttley, director of the Women's Health Program at Community Catalyst.
Horwitz, however, said the clinics should not be lumped in with those providers because their operations are fundamentally different.
Unlike hospitals and other practices that include facility fees in their charges to patients, "we don't charge or receive payments as a facility," she said.
In the midst of an injury, however, making such distinctions can be difficult. Keller said his motivation in going to urgent care was to get his wounds treated quickly instead of waiting hours in an ER, amid a spike in COVID-19 cases that would presage the country's deadly winter. He had also been to that particular CityMD clinic for a COVID test, so he knew it accepted his insurance.
Keller hadn't been wearing a helmet the day of his accident, caused by trying to prevent a bag of groceries from falling off his bike. With a bleeding forehead and banged-up knees and wrists ― Keller brushed a parked car and went off the bike himself ― he was given a tetanus shot and had elevated blood pressure from the shock of the accident. Still, in that moment, he thought it was odd that a plastic surgeon was being called in to give him a handful of stitches, he said.
"It sounds expensive and it sounds like something optional," he said. "I said, 'OK, is this going to be covered?' And they said, 'Oh, yeah, they should be covered. He does this, he comes here all the time.'"
In New York, CityMD is not subject to facility licensure requirements because it's considered a private physician practice, said Jeffrey Hammond, a spokesperson for the New York State Department of Health. As a result, rather than more sweeping regulations that would govern the practices of urgent care clinics, state health officials oversee individual practitioners and investigate complaints related to misconduct.
On its website for the location Keller visited, CityMD advertised many of the services it provides as "emergency medical services." They include physical exams, vaccinations, pediatric care, lab tests, X-rays, and treatment for sore throats and ear infections.
"Just stop by the CityMD walk-in clinic located on 138 Delancey St. between Norfolk and Suffolk St, where quick, reliable, emergency care service is available 365 days a year," the website reads.
About six weeks after receiving his stitches, Keller said, he went to the same plastic surgeon to get them removed. His health insurer, Aetna, has denied an appeal to fully cover the cost.
"It's so clear that getting stitches for a wound, for an open bleeding wound, is an emergency procedure to the normal world," Keller said.
As for his forehead, eight months later, Keller still has a visible scar.
The long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want.
So it's no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.
One that recently hit the market — winning Food and Drug Administration approval in June — is Novo Nordisk's Wegovy, a higher-dose version of the company's injectable diabetes drug, Ozempic.
Ozempic's peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it "is not a weight loss drug." Now — with a new name — it is. And clinical trials showed using it leads to significant weight loss for many patients.
"People who go on this medication lose more weight than with any drug we've seen, ever," said Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School who was not involved with any of the clinical trials.
But that leaves employers and insurers in the uncomfortable position of deciding if it's worth it.
Wegovy's monthly wholesale price tag — set at $1,349 — is about 58% more than Ozempic's, although, the company points out, the drug's injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight loss treatments are not universally covered by insurance policies.
The arrival of this new class of weight loss drugs — one from Lilly may soon follow — has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.
"The metric we try to use is value," said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, or ERIC, which represents large, self-insured employers. "If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?"
Weight loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.
New drugs like Wegovy, more effective but also pricier than previous weight loss treatments, will add more fuel to that debate.
Past treatments were shown to prompt weight loss in the range of 5% to 10% of body weight. But many had relatively serious or unpleasant side effects.
Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.
Side effects, generally considered mild, included nausea, diarrhea, vomiting and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.
Weight loss in those taking Wegovy puts it close to the 20% to 25% losses seen with bariatric surgery, said Stanford at Mass General, and well above the 3% to 4% seen with diet and other lifestyle changes alone.
Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won't develop diabetes, said Dr. Sean Wharton, an internal medicine specialist and adjunct professor at York University in Toronto who was among the co-authors of the report outlining the results of the first clinical trial on Wegovy.
Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?
Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for "anorexia, weight loss or weight gain," although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.
Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.
"Employers are going to have a bit of a challenge" deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.
The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Maryland, woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.
Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.
"I definitely feel the drug was it for me," said Pannell, who also followed the trial's guidance on diet and exercise.
The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.
After the trial ended, and the COVID-19 pandemic hit, Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.
Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk's once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk's director of media relations.
He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.
Still, that is more than the $851 monthly wholesale price of Ozempic. But, he points out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.
"There's more drug in the pen," Bachner said. "That drives the price up."
He added: "This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It's a whole different clinical program," which required new trials.
Now scientists, employers, physicians and patients will have to decide whether the new drugs are worth it.
Earlier estimates — some commissioned by Novo Nordisk — of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.
Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy's cost.
West Virginia raced ahead of the country last winter to get people in nursing homes vaccinated against COVID-19, but with cases and hospitalizations on the rise again, state officials want to know whether immunity levels are falling for residents who had their shots.
Starting in August, the state plans to begin measuring the levels of disease-fighting antibodies in the blood of vaccinated nursing home residents, which could help indicate whether they need a booster shot. The process will be voluntary and the data will be shared with federal health agencies evaluating the need for boosters.
Some experts question the strategy, particularly since the federal government has not yet authorized the extra shots.
COVID cases in West Virginia and nationally have more than tripled in the past month. Much of that surge is blamed on the delta variant, a highly contagious form of the virus sweeping the country. In June, about 10% of hospitalized COVID patients in West Virginia and 12% of COVID deaths were among fully vaccinated people, said Dr. Clay Marsh, executive dean for health sciences at West Virginia University and the state's coronavirus response coordinator. Nationally, about 3% of hospitalizations and 1% of deaths in July have been among people vaccinated for COVID.
Still, deaths attributed to COVID remain very rare in West Virginia, which is averaging two fatalities a day. Hospitalizations have risen from 65 COVID patients on July 1 to 133 as of July 28, according to state data.
"In West Virginia, we were very aggressive in vaccinating our long-term care population, but we now worry and are paying more attention about whether we have sufficient immunity in those fully vaccinated," said Marsh, often referred to as the state's coronavirus czar.
The question of the need for a booster has gained much attention lately. On Thursday, Israel announced plans to start providing booster shots this weekend to adults over 60 years old who have received their second shot at least five months earlier. The decision comes a day after the release of a paper by executives at Pfizer, one of the companies producing a vaccine, that shows a slight dip in efficacy against any symptomatic cases of COVID four months after immunization is completed. The paper, which has not been peer-reviewed, predicted that a third shot could boost disease-fighting antibodies many times higher than the level achieved from a two-shot regimen.
Pfizer said it plans to seek Food and Drug Administration authorization for a booster shot by mid-August.
Some health experts cautioned that information on antibody levels may not be helpful.
Dr. Michael Wasserman, a California geriatrician and member of the California vaccine advisory committee, said lower antibody levels don't automatically mean less immunity. "The fact that antibodies are going down is normal and it doesn't mean that those people are not immune to the virus," he said.
Antibodies do decrease over time, "but that doesn't tell us if you're exposed to COVID whether your body will move into gear and produce more. … The question of whether antibodies are a marker of adequate immunity is one we have not answered yet," Wasserman said.
West Virginia officials say their nursing home antibody testing could help FDA and other regulators evaluate the need for boosters.
"We want to gather this information and, pending what we find, work with Centers for Disease Control and Prevention and the Food and Drug Administration on an appropriate response," said Marsh. "This is a complicated issue as antibodies are not the only defense against COVID."
An antibody test will be used to measure levels against what was expected after immunization and whether it is a high-enough level to neutralize the delta variant, he said.
The state will also look at breakthrough infections and how many vaccinated people have ended up hospitalized or dead.
The state's nursing home industry supports the initiative, although officials say they've seen no increase in vaccinated COVID residents getting sick. "Our goal is to advance knowledge and information that exists about the vaccines," said Marty Wright, CEO of the West Virginia Healthcare Association, which represents nursing homes. He said antibody testing will offer one indicator of how well vaccines are still working.
Dr. David Wohl, professor of medicine and director of the vaccine clinics at the University of North Carolina School of Medicine, pointed out that even if the West Virginia initiative shows antibody levels have dropped, states can't provide booster shots until the federal government authorizes them. "You do not do a test unless there is something you can do with the information that you get from the test," he said.
Wohl said he anticipates that booster shots are likely to be needed eventually and that higher-risk populations — such as those who are immunocompromised or those in nursing homes — would likely be first to get them.
Dr. Mark Roberts, professor and former chair of the health policy and management department at the University of Pittsburgh Graduate School of Public Health, said immunity protection is much more complicated than just the level of antibodies. "It looks like protection from the vaccine wanes, but we don't know exactly how fast, and if protection wanes it may still protect people from getting sick and dying," he said.
Wasserman said a bigger question is whether officials are seeing more breakthrough infections in nursing homes and whether unvaccinated staff members are to blame.
"I argued strongly against vaccine mandates when the vaccine came out, but I am in favor of them now" for nursing home workers, Wasserman said.
California requires unvaccinated nursing home staffers to be tested regularly, requiring them to wear N95s. West Virginia requires all nursing home employees to get vaccinated or face twice-a-week testing.
In a joint statement in July, the FDA, the CDC and the National Institutes of Health said the government is analyzing laboratory data, clinical trial data and other data — which can include data from specific pharmaceutical companies — as they evaluate the need for booster shots.
"We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed."
In a press call with reporters, state health officials in Maine, Louisiana and Delaware on Thursday said they are paying attention to the booster shot issue and waiting for CDC guidance, but it's not their top priority.
"Right now our focus is getting folks first doses, not third doses," said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.
"There will be a time for booster shots, but there are still folks who do not have a first dose and that is where our team is focused," said Shah, also president of the Association of State and Territorial Health Officials.
KHN senior correspondents Jenny Gold and Markian Hawryluk contributed to this story.
Mobile clinics are part of a new push by Denver-area public health officials to find the neighborhoods where vaccinations lag behind state or county averages.
This article was published on Friday, July 30, 2021 in Kaiser Health News.
AURORA, Colo. — John Letson had seen too many apocalyptic movies to feel comfortable getting a COVID-19 vaccine initially.
"I was completely against it," the 40-year-old movie buff said, referencing "I Am Legend" and "Children of Men," in which humanity is in jeopardy, as examples of what could go wrong. "I think an untested thing during a pandemic has later effects that we don't know yet."
After discussing with a doctor the various myths that have arisen about the vaccines, his opposition softened. On the way to get pizza in late June, he happened upon a mobile vaccination clinic behind a bus stop on Colfax Avenue in this Denver suburb and got his first dose.
"I was here. They were here," he explained, as a nurse gave him a shot of the Pfizer-BioNTech vaccine.
The mobile clinic in the East Colfax neighborhood is part of a new push by Denver-area public health officials to find the neighborhoods where vaccinations lag behind state or county averages. Using detailed maps that show vaccines given by ZIP code or census tract, the health departments highlight underperforming areas being masked by a county's overall vaccination rate. They then partner with community organizations with intimate knowledge of those neighborhoods to determine strategies to address the specific barriers keeping residents from being inoculated.
As the Biden administration seeks to boost the nation's vaccine rate by going "neighborhood by neighborhood," in the president's words, the approach taken on Colfax Avenue could become a model for the rest of the country. According to the National Association of County and City Health Officials, such efforts depend on the accuracy of the data and the willingness of jurisdictions to work together, which can be difficult for some regions to accomplish. The Denver-area effort has managed to use granular data across seven counties to help raise the vaccination rate by an estimated 4 percentage points in one troubled Colfax area in about a month.
"We have to do the dirty work to be with the community and listen to what their actual concerns are," Nicole Steffens, a program manager with the nonprofit Colorado Health Institute, said in a presentation on the mapping tool. "We can take all the data that we want based on large, mass groups of people on surveys with vaccine hesitancy or why people aren't getting vaccinations, but that might not actually apply to that very specific location."
The public health agencies cooperating in the Denver region represent 3 million Coloradans, about 60% of the state's population. They overlay data from the state vaccine database with the COVID caseload, poverty rates and racial demographics to highlight areas of concern.
"We weren't very surprised to see the areas that lit up," said Meghan Prentiss, with the Tri-County Health Department, which serves Adams, Arapahoe and Douglas counties east and south of Denver. "They all kind of followed those common trends of other health indicators."
East Colfax topped the department's priority list. The neighborhood, which spans the border between Denver and Aurora, is one of the more impoverished in the metro area, with large numbers of immigrants and minorities, many of whom speak neither English nor Spanish.
Two-thirds of the city of Denver's eligible residents were fully vaccinated by the end of June, compared with just above 30% in the East Colfax neighborhood. In the 80010 and 80011 ZIP codes, which include the Colfax corridor, fewer than half of those ages 30 to 39 were vaccinated, compared with more than 75% in more affluent Washington Park or City Park.
Part of the problem, people in the community told health officials, was transportation.
Initially, the state had set up mass vaccination clinics in the center of Denver. But many East Colfax residents have no car, relying primarily on public transit. It's about a 50-minute ride one way on the Route 15 bus to the Ball Arena vaccine site. For many, that was too far to venture.
"It looks great on TV to have these mass clinics where people drive through," said Judy Shlay, an associate director who runs the immunization program for Denver Public Health, which operates the mobile vaccine clinic. "But we have to be more agile and flexible for people who are maybe more hesitant to go downtown, or because they have to take three buses to get there."
Moreover, people in the East Colfax area often work hourly jobs as independent contractors or gig workers and get no time off to get vaccinated. And if they fall ill after getting vaccinated, they might miss another day's pay.
So public health officials worked with transit authorities to identify where high-ridership bus lines intersected in the corridor, settling on a location by a Walmart, a Sprouts grocery store and the Little Caesars restaurant where Letson had gone to buy pizza.
On two days in late June, the mobile clinic vaccinated a total of 150 people, most receiving their first shots. Among them was Marley Sosa, 18, whose sister is a nurse who worked at the clinic.
"She made me feel safe about it," he said. "People are just hesitant because it's a new vaccine."
Ira Milhouse, 40, who is homeless, said he got vaccinated so he could receive a $50 grocery gift card provided as an incentive. Stephanie Aguilar, 18, came after clinic staffers walked through the shopping plaza where the van was parked, informing everyone they could get vaccinated that day.
Others inquired about the incentives but walked away unvaccinated.
Janice Robinson, 53, had come to the bus stop, part of her daily routine of "taking a ride" with no particular destination. "I don't want the vaccine," she said. "I don't think I need it. I don't really go anywhere."
Desiree Mister, 45, had just finished a shift at Sprouts. She was tired of wearing a mask and wanted to get vaccinated. But she wasn't sure if she could sell her plasma if she got vaccinated. She decided she'd come back the following week after a plasma draw. (The Food and Drug Administration says people who have received COVID vaccines can continue to donate blood or sell plasma without a waiting period, although rules at plasma collection sites can vary.)
Early data, Shlay said, showed that vaccine access was highly correlated with income, and those able to connect digitally had an easier time tracking down shots. It proved much more difficult for East Colfax residents with language barriers.
That meant the vaccine had to come to East Colfax, which has few police or fire stations, libraries or rec centers that could host vaccine clinics. "We couldn't anchor something in there," Shlay said. "So we had to use small organizations that maybe aren't reaching everybody."
One of those was the Village Exchange Center, a nonprofit just a block off Colfax Avenue. The center offers benefits to immigrants, including a food bank that serves 4,000 people a day. Workers there inserted flyers about the vaccines into the bags of food they distributed and held information sessions.
"We have several pastors that have just said, 'This is evil, and we're not going to do it,'" said Amanda Blaurock, the center's executive director. "And we respect that. We don't go around decisions that community members have made. We just say, 'We're hosting it, and if you want it, we're trying to make it as accessible as possible.'"
One census tract in the area has a recorded population of 4,389, and as of mid-June, slightly more than 1,300, or about 30%, were fully vaccinated. Health officials would need to get roughly 1,700 more vaccinated to reach their 70% goal. A month later, the rate had climbed to 34%, and health officials expect more dramatic gains in the coming weeks after people receive their second doses.
The initial success has buoyed interest in more transit-based vaccine clinics. Shontel Lewis, who represents the East Colfax area on the Regional Transportation District mass transit agency's board of directors and spearheaded its involvement, said future clinics might be held at park-and-ride locations and other bus stops in underserved areas.
"The approach is often cookie-cutter. We tend to go with the same strategies, and then, when no one comes, we just throw our hands up," Lewis said.
If the goal is to get everybody vaccinated, she said, the interventions need to be tailored to specific communities. "Our approach might be different," she said, "but our goal is the same."
BOULDER, Mont. — Twice a year, Brian Tichenor makes the 1,200-mile drive each way from his home in Kansas to a defunct uranium mine in Montana, where he takes an elevator 85 feet below the surface to sit amid radioactive radon gas to ease the pain from his chronic eye condition.
"I found it like I think a lot of people do," said Tichenor, 67. "It's a point of desperation with conventional treatment."
While radon is commonly known as a hazardous gas removed from basements, people in pain travel to Montana and pay to breathe, drink and bathe in its radioactive particles. The travelers view the radon exposure as low-dose radiation therapy for a long list of health issues. But the Environmental Protection Agency and the World Health Organization, among others, blame the gas as the second-leading cause of lung cancer. Although cancer doctors use radiation as a front-line treatment to destroy dangerous cells, its role in the U.S. in low doses for other ailments is disputed. The pandemic has recharged that debate as clinical trials across the world test whether low doses of radiation can help treat COVID-19 patients.
But radon gas isn't the same radiation U.S. doctors use, radiation experts caution. Radon is just one of the radioactive chemical elements and, because it's a gas, it can be inhaled, making it particularly dangerous. Sitting in a radon-filled room and targeted radiation treatment in a medical facility are as different as "chalk and cheese," said Brian Marples, a professor of radiation oncology at the University of Rochester.
"In clinical therapy, we know exactly what the dose is, we know exactly where it's going," he said.
Marples said much of the argument for radon's therapeutic use relies on historical reports, unlike evidence-based research on clinical radiation. Still, some radiation experts are split on what level of radon should be deemed dangerous and whether it could have positive health effects.
Another concern: The radon treatment in the mines is largely unregulated. The Montana Department of Public Health and Human Services doesn't have the authority to permit or license the mines, though department spokesperson Jon Ebelt said the adverse health risk from exposure is well known. The EPA also doesn't have the power to mandate limits on radon.
Nonetheless, each year travelers head to western Montana, where four inactive mines flush with radon are within 11 miles of one another near the rural communities of Basin and Boulder. Day passes range from $7 to $15. The gas naturally forms when radioactive elements in the mountains' bedrock decay.
Outside the Merry Widow Health Mine, a billboard-like banner announces "Fountain of Youth. FEEL YOUNG AGAIN!" Inside its tunnels, water seeps from the rock walls. Those who want full immersion can slip into a clawfoot tub filled with radon-tainted water. People soak their feet and hands in water or simply sit and work on a puzzle. On a bench sits a printout of a Forbes article on clinical trials that show low-dose radiation could be a treatment for COVID-19.
To owner Chang Kim, 69, his business is a mission, especially for those with chronic medical conditions such as arthritis or diabetes. Those who swear by radon therapy say that, in low doses, a little stress on the body triggers the immune system to readapt and reduces inflammation.
"The people coming to the mines, they're not stupid," Kim said. "People's lives are made better by them."
He learned about the mines 14 years ago when he and his wife, Veronica Kim, lived in Seattle and a connective tissue disease crumpled Veronica's hands and feet. Traditional medicine wasn't working. After two sessions a year in the mines ever since, Veronica smiles when she shows her hands.
"They're not deformed anymore," she said, adding she's been able to cut down on her use of meloxicam, a medication to reduce pain and swelling.
Tichenor said going to a mine with radon over six years has been one of the few things to calm his scleritis, a disorder that causes pain he describes as ice picks stabbing his eyes. As for its potential danger, he said radon treatment is just like any medication: Too much can cause harm.
In the U.S., the EPA maintains that no level of radon exposure is risk-free even though everyone encounters the element in their lives. The agency notes radon is responsible for about 21,000 lung cancer deaths every year. It recommends that homeowners with radon levels of 4 picocuries per liter or more should add a radon-reduction system. By contrast, the owners of Montana's oldest radon therapy mine, Free Enterprise Radon Health Mine, said their mine averages around 1,700.
Monique Mandali said the federal guidelines are "a bunch of baloney." Mandali lives in Helena, about 40 minutes from the mines, and tries to fit in three sessions at Free Enterprise a year — 25 hours of exposure spread out over 10 days for arthritis in her back.
"People say, 'Well, you know, but you could get lung cancer.' And I respond, 'I'm 74. Who cares at this point?'" she said. "I'd rather take my chances with radon in terms of living with arthritis than with other Western medication."
Antone Brooks, formerly a U.S. Department of Energy scientist who studied low-dose radiation, is among those who believe the federal government's no-level-of-radon-exposure stance goes too far. He pointed to research that indicates low doses of radiation potentially turn on pathways within bodies that could be protective. Though what's considered a "low dose" depends on who's talking.
"If you want to go into a radon mine twice a year, I'd say, OK, that's not too much," he said. "If you want to live down there, I'd say that's too much."
In the early 1900s, before antibiotics were popularized, small doses of radiation were used to treat pneumonia with reports it relieved respiratory symptoms. Since then, fear has largely kept the therapeutic potential of low-dose radiation untapped, said Dr. Mohammad Khan, an associate professor with the Winship Cancer Institute at Emory University. But amid the pandemic, healthcare providers struggling to find treatments as hospital patients lie dying have been giving clinical radiation another look.
So far, the trials Khan has led show that patients who received targeted low-dose radiation to their lungs got off oxygen and out of the hospital sooner than those without the treatment. Khan said more research is necessary, but it could eventually expand clinical radiation's role for other illnesses.
"Some people think all radiation is the same thing, that all radiation is like the Hiroshima, Nagasaki bombs, but that's clearly not the case," Khan said. "If you put radiation in the hands of the experts and the right people — we use it wisely, we use it carefully — that balances risk and benefits."
The logo for Free Enterprise Radon Health Mine is a miner skipping with crutches in the air. Roughly 70 years ago, a woman said her bursitis disappeared after visiting the mine several times. Thousands of others followed suit.
"We believe in it," said Leah Lewis, who co-owns the mine with her husband, Ryan Lewis, and has relied on it to help treat her Crohn's disease.
The couple live on-site and grew up in Boulder, going into the tunnels just as their 5-year-old daughter does now. Her husband's great-grandfather owned the mine, and the business has been in the family ever since.
"Not one person has come back and said they've gotten lung cancer here," Ryan Lewis said. "If they did, they would shut us down so fast."
Aside from a billboard outside Helena, the family doesn't really advertise the business. Clients tend to find them. Like many companies, Ryan Lewis said, Free Enterprise took a hit last year as people canceled plans because of the pandemic. Before that, he said, the business broke about even, adding that radon can be "a hard sell."
But he said the family of cattle ranchers plans to keep it running as long as it doesn't cost them money.
"The land is an investment, and we want to keep it in the family," he said. "And there are a lot of people who use this, and there's some responsibility there."
A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices.
This article was published on Thursday, July 29, 2021 in Kaiser Health News.
Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.
By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.
Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.
A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge's ruling is expected any day.
"If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush," government lawyer Jacob Lillywhite said in oral arguments last month.
Pfizer's legal argument "is aggressive," said Chris Robertson, a professor of health law at Boston University. "But I think they've got such a political tailwind behind them" because of pocketbook pain over prescription medicine — even though it's caused by pharma manufacturers. Pfizer's message, "'We're just trying to help people afford their drugs,' is pretty attractive," he said.
That's not all that's working in Pfizer's favor. Courts and regulations have been moving pharma's way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.
Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.
"It's infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts," said Michelle Mello, a professor of law and medicine at Stanford University. "Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights."
Pfizer's lawsuit, in the Southern District of New York, seeks a judge's permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.
Letting pharma companies put money directly into patients' pockets to pay for their own expensive medicines "does induce people to get a specific product" instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. "It's kind of the definition of a kickback."
Government rule-makers have warned against such payments since the launch of Medicare's Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.
Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.
At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are "bona fide, independent" organizations that don't match drugmaker money with specific drugs.
Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.
Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.
Under such arrangements, every $1 million channeled through a charity "has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government," Andrew Baum, a Citi pharma stock analyst, wrote in 2017.
Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its "desire to put this legal matter behind us."
The PAN Foundation and three othercharities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.
PAN's settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.
The 2019 PAN agreement related to "legacy matters" and "did not involve any of PAN's current operations or disease funds," organization CEO Dan Klein said via a spokesperson. "Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy."
But legal troubles have hardly slowed the pharma-funded patient assistance business.
Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.
Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.
Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.
If Pfizer's lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University's Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department's inspector general estimated.
Pharma companies can "learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient," Anderson said. "You get a huge return."
Pfizer argues that its proposal, which the HHS inspector general called "highly suspect" in an advisory opinion before the company filed its lawsuit, is legal and sensible.
"Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs," company spokesperson Steven Danehy said.
But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS' Office of Inspector General declined to comment.)
Pfizer has "priced itself out of the market," he said. The company is seeking to "do something that's unprecedented, to upend decades of settled law and agency guidance" to boost sales of "what is the most expensive cardiovascular drug ever launched in the United States."
After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company's contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.
But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.
A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren't identified.
A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.
Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.
The federal kickback law doesn't mention copay assistance charities "and wasn't designed with these programs in mind," said Mello, of Stanford. Pfizer's lawsuit "should be a loud, clanging call to Congress" to explicitly define drug assistance subsidies as illegal kickbacks, she said.