Ongoing clinical trials are primarily designed to show whether COVID-19 vaccines prevent any symptoms of the disease — which could be as minor as a sore throat or cough.
This article was published on Wednesday, October 28, 2020 in Kaiser Health News.
The White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at "warp speed." But some scientific experts warn they're all expecting too much, too soon.
"Everyone thinks COVID-19 will go away with a vaccine," said Dr. William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.
Ongoing clinical trials are primarily designed to show whether COVID-19 vaccines prevent any symptoms of the disease — which could be as minor as a sore throat or cough. But the trials, which will study 30,000 to 60,000 volunteers, will be too short in duration and too small in size to prove that the vaccines will prevent what people fear most — being hospitalized or dying — by the time the first vaccine makers file for emergency authorization, expected to occur later this year, Haseltine said.
The United States should hold out for an optimal vaccine, with more proven capabilities, Haseltine argued. Others say the crushing toll of the pandemic — which has killed at least 225,000 Americans — demands that the country accept the best vaccine it can achieve within the next few months, even if significant questions remain after its release.
"There's a tension between getting every piece of information and getting a vaccine [out] in time to save lives," said Dr. William Schaffner, a professor of preventive medicine and health policy at the Vanderbilt University Medical Cancer.
"Would we like to know if the vaccine reduces illness or mortality? Of course," said Dr. Peter Lurie, a former FDA official and the current president of the Center for Science in the Public Interest. "But there is a real time pressure. This is a pandemic. It's explosive."
"Simply preventing mild cases is not enough and may not justify the risks associated with vaccination," said Peter Doshi, an associate professor at the University of Maryland School of Pharmacy who detailed his concerns in an editorial in The BMJ.
But vaccine experts say there are good reasons to focus on milder cases of COVID-19.
Vaccines that prevent mild disease typically prevent severe disease, as well, said Dr. Arnold Monto, an epidemiologist at the University of Michigan's School of Public Health and temporary chair of the vaccine committee.
For example, the original studies of the measles vaccine showed only that it prevented measles, not hospitalizations or deaths, said Dr. Kathleen Neuzil, director of the University of Maryland's Center for Vaccine Development and Global Health.
Later studies found that measles vaccines dramatically reduce mortality. According to the World Health Organization, worldwide deaths from measles fell by 73% from 2000 to 2018 because of vaccines.
"There simply does not exist an example in vaccinology of vaccines that are effective against mild disease that are not more effective in severe disease," said Dr. Philip Krause, deputy director of the vaccine office at the FDA's Center for Biologics Evaluation and Research, at Thursday's hearing.
Dr. Paul Offit, who developed the rotavirus vaccine, compared preventing the coronavirus to fighting a fire.
"If you put out a small fire in the kitchen, you don't have to worry about the whole house catching fire," said Offit, a member of the FDA advisory committee on vaccines.
Proving that a vaccine prevents severe illness and death is harder than showing it protects against mild illness because hospitalizations and deaths are much rarer. That's especially true among the type of health-conscious people who volunteer for vaccine trials, who are probably more likely than others to wear masks and socially distance, Schaffner said.
"When we looked at hospitalizations in older adults with influenza, those were two-year trials," Neuzil said. In an ongoing study, in which "we're looking at typhoid vaccines in nearly 30,000 children, it's a two-year trial."
The COVID-19 pandemic has officially infected about 8.7 million Americans. Considering that the true number of Americans infected is estimated to be six to 10 times higher than reported, the mortality rate is about 0.6%, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security.
Scientists agree that the ideal vaccine would provide "sterilizing immunity" — which means preventing not only disease symptoms but any infection with the virus, said Dr. Corey Casper, a vaccinologist with the Fred Hutchinson Cancer Research Center and chief executive officer at the Infectious Disease Research Institute in Seattle.
Few expect COVID-19 vaccines to be that effective. "We're trying to lower that bar and determine how much lower is acceptable," Casper said.
Preventing mild disease could curb disease and prevent illness, Casper said.
"We're probably not going to have the perfect vaccine," he said. "But I do think we're likely to have vaccines that, if we can show they're safe, can put an inflection point on this pandemic. … I think it's still important to have a vaccine that has some effect even on mild illness."
Flu shots aren't super effective — with effectiveness each year ranging from 19% to 70% — but they're still extremely useful, Casper said.
During the 2018-19 U.S flu season, vaccination prevented an estimated 4.4 million influenza illnesses, 2.3 million medical visits, 58,000 hospitalizations and 3,500 influenza-associated deaths, according to the Centers for Disease Control and Prevention.
A trial of 30,000 to 60,000 people is already fairly large by historical standards. Dramatically expanding the size beyond that isn't practical in a compressed time frame, Krause said.
"If the endpoint of the trial is severe disease, the trials may need to be almost 10 times as big," he said at the meeting. "And those trials would be infeasible and we would never get a vaccine."
On the other hand, "if there is a vaccine that appears to have high efficacy or appears to be capable of saving lives, one doesn't want to stop that vaccine if there is a significant chance that it will save lives," Krause said.
Although the coronavirus vaccine trials are measuring severe disease or death, these are "secondary endpoints," meaning the current size of the study isn't large enough to produce a statistically significant answer, Neuzil said.
Whether vaccines reduce severe disease and death will become clear in later studies, after vaccines are distributed, Neuzil said.
Offit said the debate revolves around one question: "How much uncertainty are we willing to live with, knowing that we're facing a virus that has brought us to our knees?"
If President Donald Trump wins reelection next week, it seems unlikely he will unveil the health plan he's been promising since before his election in 2016. Still, other aspects of healthcare could be featured in his second-term agenda.
Not having a replacement plan for the Affordable Care Act may be just fine with many of his supporters and conservatives. Most Republicans don't want the federal government to remake the nation's health system, said Grace-Marie Turner, of the conservative Galen Institute. "It's a different philosophy from Democrats, who think it needs to be a big program," she said. "Conservatives, we think of it in a more targeted way."
Trump, of course, repeatedly promises something big. "We will have Healthcare which is FAR BETTER than ObamaCare, at a FAR LOWER COST – BIG PREMIUM REDUCTION,"he tweeted Oct. 12 — hardly the first time he's made a similar promise. "PEOPLE WITH PRE EXISTING CONDITIONS WILL BE PROTECTED AT AN EVEN HIGHER LEVEL THAN NOW. HIGHLY UNPOPULAR AND UNFAIR INDIVIDUAL MANDATE ALREADY TERMINATED. YOU'RE WELCOME!"
But Trump needs a contingency plan if the Supreme Court accepts his argument that the ACA should be overturned. The justices are scheduled to hear the case the week after Election Day. Administration health officials have pledged to have an alternative if the high court does as they ask. But they have refused to publicly share any details.
In September, Trump unveiled a package of healthcare proposals at a speech in North Carolina. The "America First Healthcare Plan" is less than an actual plan, though. It's a vague set of claims about things that have not happened yet — like bringing down prescription drug prices — along with a laundry list of some of his administration's lesser accomplishments on health issues, such as the initiative to help Americans with severe kidney disease and efforts to improve the availability of healthcare in rural areas.
As part of that overall health plan, Trump issued an executive order declaring "it has been and will continue to be the policy of the United States … to ensure that Americans with pre-existing conditions can obtain the insurance of their choice at affordable rates." But there is nothing in the order — or in the broader outline — to ensure that would be the case if the ACA were struck down. It would take congressional action to guarantee that.
The current court controversy over the ACA arose because Congress in its 2017 tax bill eliminated the financial penalty for not having health insurance. But Congress didn't have the votes to get rid of the mandate itself under the rules for the tax bill. Republican state officials then sued, arguing that since the Supreme Court had once upheld the ACA's mandate, calling it a tax, once the penalty was gone, the law should also be invalidated.
Trump frequently heralds his actions, erroneously saying he killed the mandate and arguing that he got rid of the most detested part of the law.
"He likes to use words, but I don't think there's been a substantive policy yet," said Len Nichols, a health policy professor at George Mason University. "I have no clue what he would do" in a second term "other than trying to repeal the ACA."
One thing Trump accomplished in his first term is a set of potentially far-reaching regulatory actions, many of which have been challenged in federal courts. Those include allowing states to implement work requirements for people who receive Medicaid health benefits and requiring hospitals and other health providers to make their negotiated prices available to the public.
Legal analysts have doubted the administration's authority to implement many changes Trump has proposed. But considering Trump has appointed hundreds of federal judges, including Supreme Court justices, the legal landscape may be changing and more of those proposals could be allowed to proceed.
Still, Trump faces uphill battles on some of his preferred health initiatives, even if Republicans control Congress.
For example, said Dan Mendelson of the consulting group Avalere Health, "I would expect that if he's reelected there would be a drug pricing agenda he continues to push." Among his proposals is having Medicare pay for drugs based on what the medicines sell for in countries that negotiate prices. That would be complicated, Mendelson said, by the fact that "the broader Republican Party doesn't want to move to a regulatory model in this country."
But the Galen Institute's Turner said not to discount the changes Trump has made, such as allowing broader sales of short-term health plans that are less expensive but offer fewer benefits than ACA plans. She said to expect actions in a similar vein in a second term. "He really has done a lot, using his executive authority, based on trying to make markets work better and give people more choice," she said. "They are strategic, targeted approaches to specific problems."
He'll certainly have a specific problem if the ACA is struck down. Americans losing their insurance won't want to wait to find out if he has a plan.
HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN's chief Washington correspondent, Julie Rovner, who has covered healthcare for more than 30 years.
As COVID-19 took hold in March, U.S. doctors limited in-person appointments — and many patients avoided them — for fear of infection. The result was a huge increase in the volume of remote medical and behavioral health visits.
Doctors, hospitals and mental health providers across the country reported a 50- to 175-fold rise in the number of virtual visits, according to a reportreleased in May by the consulting firm McKinsey & Co.
The COVID-fueled surge has tapered off as patients venture back to doctors' offices. But medical professionals and health experts predict that when the pandemic is over, telehealth will still play a much larger role than before.
Studies show patientsatisfaction with telehealth is high. And for physicians who previously were skeptical of remote care, necessity has been the mother of invention.
"There are still a few doubting Thomases, but now that we've run our practices this way for three months, people have learned that it's pretty useful," says Dr. Joseph Kvedar, president of the American Telemedicine Association and a practicing dermatologist who teaches at Harvard Medical School in Boston.
For patients, the advantages of telemedicine are clear: You typically can get an appointment sooner, in the safety of your own home or workplace, saving time and money on gas and parking — in some cases, even avoiding a loss in wages for missing work.
James Wolfrom, a 69-year-old retired postal executive in San Francisco, has had mostly virtual healthcare appointments since the pandemic started. He particularly appreciates the video visits.
"It's just like I'm in the room with the doctor, with all of the benefits and none of the disadvantages of having to haul my body over to the facility," says Wolfrom, who has Type 2 diabetes. "Even after the pandemic, I'm going to prefer doing the video conferencing over having to go there."
Telemedicine also provides care for people in rural areas who live far from medical facilities.
The growth of virtual care has been facilitated by Medicare rule changes for the COVID-19 emergency, including one that reimburses doctors for telemedicine at the same rate as in-person care for an expanded list of services. State regulators and commercial health plans also loosened their telehealth policies.
In California, the Department of Managed Healthcare, which regulates health plans covering the vast majority of the state's insured residents, requires commercial plans and most Medi-Cal managed care plans during the pandemic to pay providers for telehealth at parity with regular appointments and limit cost sharing by patients to no more than what they would pay for in-person visits. Starting Jan. 1, a state law — AB-744 — will make that permanent for commercial plans.
Five other states — Delaware, Georgia, Hawaii, Minnesota and New Mexico — have pay-parity laws already in effect, according to Mei Wa Kwong, executive director of the Center for Connected Health Policy. Washington state has one that also will begin Jan. 1.
If you are planning a telehealth appointment, be sure to ask your health plan if it is covered and how much the copay or coinsurance will be. The appointment may be through your in-network provider or a telehealth company your insurer contracts with, such as Teladoc, Doctor On Demand or MD Live.
You can also contact one of those companies directly for a medical consultation if you don't have insurance, and pay between $75 and $82 for a regular doctor visit.
If you are one of the 13 million Californians enrolled in Medi-Cal, the state's Medicaid program, you can get telehealth services at little to no cost.
Large medical offices and health systems usually have their own telemedicine platforms. In other cases, your provider may use a publicly available platform such as FaceTime, Skype or Zoom. Either way, you will need access to a laptop, tablet or smartphone — though, for a phone conversation, a landline or simple cellphone will suffice.
Smartphones with good cameras can be particularly useful in telemedicine because high-resolution photos can help doctors see certain medical problems more clearly. For example, a photo from a good smartphone camera usually provides enough detail for a dermatologist to determine whether a mole requires further attention, Kvedar said.
Relatively inexpensive apps and at-home tools enable you to measure your own blood pressure, pulse rate, oxygen saturation level and blood sugar. It's a good idea to monitor your vitals and have the numbers ready before you start a virtual visit.
Be aware that a remote visit is not right for every situation. In the case of serious injury, severe chest pain or a drug overdose, for example, you should call 911 or get to the ER as quickly as possible.
Virtual visits also are not recommended in other cases for which the doctor needs to lay hands on you.
Wolfrom has had only a few in-person health visits this year, one of them with a podiatrist who checks his feet every six to 12 months for diabetes-related neuropathy. "That can only be done when you are in the room and the podiatrist is touching and feeling your feet," Wolfrom says.
Face-to-face visits are generally better for young children. Kids often require vaccinations, and it's easier for doctors to monitor their growth and development in person, says Dr. Dan Vostrejs, a pediatrician at Santa Clara Valley Medical Center in San Jose.
In general, telemedicine is effective in cases that would typically send you to an urgent care clinic, such as minor injuries or flu-like symptoms, including fever, cough and sore throat.
It is also increasingly used for post-surgical follow-ups. Telemedicine can be a godsend for geriatric or disabled patients with reduced mobility. And it's a no-brainer for mental healthcare, which is mostly talking anyway.
Among the top telehealth adopters are medical specialists who treat chronic illnesses such as diabetes, hypertension, cardiovascular disease and asthma, says Dr. Peter Alperin, a San Francisco internist and vice president of product at Doximity, a kind of LinkedIn for medical professionals.
Providers can monitor patients' vitals remotely and discuss lab results, diet, medications and any symptoms in a video chat or a phone conversation. "If you happen to see something that's awry, you can bring them into your office," Alperin says, adding it's "a better form of triage."
But telemedicine has some serious disadvantages. For one thing, the less formal setting can allow some routine medical practices to slip through the cracks.
In the second quarter of this year, blood pressure was recorded in 70% of doctor office visits compared with about 10% of telemedicine visits, according to a study published early this month.
Elsa Pearson, a resident of Dedham, Massachusetts, had a medical appointment scheduled in March, which was switched to a telephone call because of the pandemic-induced lockdown.
"It was honestly the most efficient appointment I've had in my life," says Pearson, 30. But, "I must admit, without the push of having the labs right there when you leave the appointment, I've yet to get them done."
Perhaps the biggest pitfall in telehealth is the loss of a more intimate and valuable doctor-patient relationship.
In a recent essay, Dr. Paul Hyman, a Maine physician, reflected on the times when an unexpected discovery during an in-person examination had possibly saved a patient's life: "A discovery of an irregular mole, a soft tissue mass, or a new murmur — I do not forget these cases, and I do not think the patients do either."
When Tiffany Qiu heard how much her surgery was going to cost her, she was sure the hospital's financial department had made a mistake. Qiu, who already knew from a breast cancer scare earlier that year that her plan required a 30% coinsurance payment on operations, pressed the person on the phone several times to make sure she had heard correctly: Her coinsurance payment would be only 20% if she had the procedure at Palomar Medical Center in Poway, California, about 38 miles south of where Qiu lives.
"I was kind of in doubt, so I called them a second time," said Qiu. "They gave me the exact same amount."
Qiu had been diagnosed with uterine polyps, a benign condition that was making her periods heavier and more unpredictable. Her OB-GYN proposed removing them but said it was safe to wait. Qiu said that she asked about the possibility of doing it in the doctor's office under local anesthesia to make the procedure cheaper, but that her doctor rebuffed her suggestion because of her preference for general anesthesia.
Because Qiu thought she was getting a deal on her usual 30% share of the bill, she decided to go ahead with the polyp removal on Nov. 5, 2019. As she sat in the waiting room filling out forms, staffers let her know she needed to pay in full before the surgery.
Unease set in. The hospital asked for the 20% coinsurance — $1,656.10 — that she had been quoted over the phone, but Qiu hadn't been told she needed to pay on the day of the procedure. As she handed over her credit card, she confirmed one more time that this would be her total patient responsibility, barring complications.
The surgery was over in less than 30 minutes, and she walked out of the hospital with her husband, feeling perfectly fine.
Then the bill came.
Patient: Tiffany Qiu is a 49-year-old real estate agent and mother of two who lives in Temecula, California. Her family of four is covered by a Blue Shield of California policy that she and her husband purchased on the marketplace. Last year, they paid a $1,455 monthly premium, with an individual annual $1,850 deductible and an individual out-of-pocket maximum of $7,550.
Total Bill: Palomar Health billed Blue Shield $22,219.64 for the polyp removal, which the insurer negotiated down to $8,576.79. Blue Shield paid $5,769.72 and stated in an explanation of benefits document that Qiu was responsible for a $334.32 deductible and $2,472.75 coinsurance.
Because Qiu had already paid $1,873.20 on the day of surgery, the hospital billed her an additional $933.87, which meant Qiu was on the hook for the remainder of her 30% coinsurance.
These figures don't include the fees Qiu paid for anesthesia or her doctor's services.
Service Provider: Palomar Medical Center in Poway is one of three hospitals in the Palomar Health system. Palomar Health is a San Diego County public healthcare district, which means the healthcare facilities are nonprofit and receive property taxes as a portion of their revenue stream. The system is governed by a board of directors elected from within the district's boundaries.
What Gives: Hospitals and surgery centers sometimes offer discounts if patients are uninsured and able to pay with cash or a credit card. Physicians may even offer discounts on a patient's share of the costs if they know the patient is unemployed or has fallen on hard times. But regularly offering discounts to attract patients is not common, and could even be fraudulent if the patients are insured through Medicare, said Paul Ginsburg, director of the USC-Brookings Schaeffer Initiative for Health Policy.
In Qiu's case, the hospital seemed to be offering a discount on the insurer's normally required coinsurance.
"The hospital would be in breach of their contract with the insurance if they did not bill her for that amount," said Martine Brousse, a California-based patient advocate and medical billing consultant for AdvimedPRO. "She owes what the insurance has calculated, and the facility has every right to demand payment."
Copayments and coinsurance exist, in theory, so patients have "skin in the game." They have to pay a clearly defined portion of the cost of their care, according to their policy, so they will shop around and use medical care judiciously (though many health experts say coinsurance amounts have gotten so high that many cannot afford them).
Resolution: If she hadn't been quoted 20%, Qiu said, she would have shopped for a better deal. She flies to China often to visit her mother and was open to getting the surgery done there.
Qiu called the hospital to ask why she was being billed a second time, despite the lack of complications during the surgery. She remembers the back-and-forth over the remaining bill was exhausting, especially because it happened over the holidays.
"I got tired and said, 'I don't want to play this game anymore,'" Qiu recalled. "'If you want to send it to collections, you can do it, but I'm not going to pay for it.'"
The bill landed at a collection agency called IC System. In a May 23 phone call, Qiu said, a representative offered to slash the remaining bill by 25% if she would just pay that day.
But Qiu refused, though she could easily afford to pay. She's undaunted by the risk the unpaid bill poses to her credit score, preferring instead to fight the hospital on behalf of other patients who may not have the time or luxury to persist.
The experience left her feeling as if the hospital offered her a fake discount to reel in her business.
"I double-checked and tripled-checked with them," Qiu said. "They have financial departments that should be verifying this with my insurance company."
Another thing to note is how much the hospital billed Qiu for a simple outpatient procedure: $22,219.64. That amount is "totally laughable," said Dr. Merrit Quarum, founder of WellRithms, a company that works with self-funded employers and other clients to make sense of complex medical claims.
Not only is the charge far out of line with what that procedure typically costs in that region (around $5,500), but Qiu is now stuck paying a larger amount as her share under the terms of her insurance. This is how those "sticker prices" that few people pay still drive up costs for individuals.
After a reporter's call, Palomar Health looked back at phone records, confirmed Qiu's version of events and said a hospital staffer had made a mistake by quoting her a 20% cost-sharing obligation. That percentage then got automatically put into her patient notes and was on the bill of estimated costs she signed and paid on the day of surgery, even though it was incorrect.
They apologized for giving the mistaken impression that Qiu was getting a discount. Staff members are not authorized to offer discounts when providing estimates, said Derryl Acosta, a spokesman for Palomar Health.
Acosta also pointed out other communication breakdowns, like dropping the complaint Qiu phoned in after she received the second bill in late November. Her issue did not get put into the standard customer complaint process, which would have elevated the problem and triggered an investigation into the phone records. That's why Qiu's bill was sent to the collection agency.
"We definitely admit that the call should have been handled differently," Acosta said. "We now have a new call center that we believe will handle this type of call better."
Because Palomar Health was able to see in their phone records that a staffer had confirmed the erroneous 20% coinsurance amount to Qiu, the health system will change her bill to reflect what she was promised. Qiu will get a statement in the mail saying she has a zero balance, Acosta said.
The Takeaway: Multiple medical billing advocates who reviewed Qiu's case praised her for her tenacity in calling the hospital financial department twice before the procedure. But as she herself acknowledged, most people don't have the time or spine to fight.
To avoid such situations, experts advised, patients should check in with their insurer about the discounts offered, as hospital staffers may be poorly trained or ill informed.
If a patient hears conflicting information about charges before a procedure, they need to approach their insurer to confirm the details of their own policy, said Brousse, the patient advocate.
The simple fact that a hospital staffer misinformed a patient isn't a legal reason to force a hospital to lower a bill, Brousse said.
Also, get promises in writing — before the day of surgery. Make sure the offer is explicit about which services are included and what might count as a complication. Ask whether you'll have to pay upfront.
Initial estimated bills can be full of asterisks and "weasel words," said Akshay Gupta, co-founder of CoPatient, a medical bill review and patient advocacy company.
"Even though she tried to be diligent, obviously she still didn't know that she would need to get something that was legally enforceable," said Gupta.
Dan Weissmann, host of the podcast "An Arm and a Leg," reported the radio interview of this story. Joe Neel of NPR produced the interview with KHN Editor-in-Chief Elisabeth Rosenthal on "Morning Edition."
Bill of the Month is a crowdsourced investigation by KHN and NPRthat dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
Verily had two sites in Alameda County, and one was shuttered by May. The second, located at an Oakland church, closed in August and is set to reopen using a different testing vendor.
This article was published on Monday, October 26, 2020 in Kaiser Health News.
OAKLAND, Calif. — Amid fanfare in March, California officials celebrated the launch of a multimillion-dollar contract with Verily — Google’s health-focused sister company — that they said would vastly expand COVID testing among the state’s impoverished and underserved communities.
But seven months later, San Francisco and Alameda counties — two of the state’s most populous — have severed ties with the company’s testing sites amid concerns about patients’ data privacy and complaints that funding intended to boost testing in low-income Black and Latino neighborhoods instead was benefiting higher-income residents in other communities.
San Francisco and Alameda are among at least 28 counties, including Los Angeles, where California has paid Verily to boost testing capacity through contracts collectively worth $55 million, according to a spokesperson for the California Governor’s Office of Emergency Services. About half of them have received COVID tests through six mobile units that travel among rural areas.
Gov. Gavin Newsom has heralded the investment as a game changer in addressing persistent inequities in access to COVID testing across the state that tend to fall along lines of ethnicity and income. The goal, he said in April, touting six new Verily testing sites, was to “make sure we’re truly testing California broadly defined, not just parts of California and those that somehow have the privilege of getting ahead of the line.”
Yet the roadblocks for getting underrepresented populations to use the program soon became apparent to Alameda County officials. In a June letter to California Secretary of Health Mark Ghaly, Oakland Mayor Libby Schaaf and other members of the county’s COVID-19 Racial Disparities Task Force raised numerous concerns about the Verily protocols.
Among their complaints: People signing up for a test through Verily had to do so online, using an existing or newly created Gmail account; the sign-ups were offered only in English or Spanish; and participants were asked to provide sensitive personal information, including their home address and whether they were managing chronic health conditions such as diabetes, obesity or congestive heart failure, which could expose their data to third-party use.
“It is critical in this crisis that we continue to build trust between government and healthcare providers and vulnerable communities,” the task force members wrote.
Verily had two sites in Alameda County, and one was shuttered by May. The second, located at an Oakland church, closed in August and is set to reopen using a different testing vendor. Alameda County testing director Dr. Jocelyn Freeman Garrick said that while the Verily sites helped the county reach testing goals in terms of raw numbers, they were phased out because of long wait times of a week or more for results, and because the tests were not reaching the residents in greatest need.
Verily does not manufacture the COVID tests used at its California sites. It contracts with major corporations such as Quest Diagnostics and Thermo Fisher Scientific to provide the test kits and perform the lab work. What Verily provides is a digital platform where people are screened for symptoms, schedule testing appointments at participating sites and check back for test results.
Dr. Noha Aboelata is CEO of Roots Community Health Center, an East Oakland clinic that serves mostly African Americans and is one of the original Verily sites in Oakland. Her experience with Verily is best described as a tale of two lines.
In May, Aboelata worked with Verily to establish a walk-up site at her clinic, rather than the drive-thru model the company typically uses. There would be two lines: one for people who scheduled their appointments through Verily’s online portal; and a second for people who had not preregistered with Verily. Roots would staff both lines, and Verily would supply test kits and personal protective equipment including masks, which were “like gold” at the time, Aboelata said.
Problems emerged almost immediately, she said. People were suspicious of the requirement that they sign up with a Gmail account, and the request for personal information, such as health status and risk factors. “You don’t necessarily want to share that with Google,” Aboelata said.
Then there was the language in the privacy policy that allows for sharing data with third parties. “That always is going to raise suspicion and concern in our community,” she said.
The people who ended up in the Verily-registered line, she said, tended to be white and to come from wealthier ZIP codes outside East Oakland. And because Verily never changed the website language describing Roots as a drive-thru site, many were angry at having to walk up.
“We had people coming from all over the Bay Area who were frustrated that they had to park in Oakland, where they had probably never been and didn’t seem to want to be,” she said. “They were creating quite a scene, and some were saying, ‘I want to talk to the manager.’” She had to ask a few people to leave. “One of them was saying, ‘This is so Oakland, and I hope you all get the virus.’ It was pretty awful.”
The Roots line for clients who did not register through Verily, on the other hand, was made up mostly of people of color from the community who long had come to the clinic for medical care, she said.
When Aboelata looked at the data, the disparities were obvious: 12.9% of people tested in the non-Verily line were positive for COVID-19, while just 1.5% of people tested in the Verily-registered line were positive. For Aboelata, it was clear that the two lines were testing two entirely different populations.
After just six days of testing, Aboelata asked Verily to leave.
“From where we sit, this is an old story,” she said. “Corporations that are not really invested in the community come helicoptering in, bearing gifts, but what they’re taking away is much more valuable.” That thing of value, Aboelata believes, is the data Verily requests from everyone who signs up for a test.
In San Francisco, Verily mobile testing clinics have also been sidelined. County officials declined to provide an explanation. However, multiple people with knowledge of the testing efforts said the Verily registration process proved chaotic for homeless people and others in the Tenderloin district, one of the city’s poorest neighborhoods.
Kenneth Kim, clinical director of Glide, an outreach center that helped run the Tenderloin site, said many homeless residents coming in for testing had Gmail accounts, as Verily required, but could not remember their passwords. When staffers at the testing site tried to help them retrieve their passwords, they found that Google’s two-factor authentication process required users to have the same phone number as when they signed up, which few of the homeless participants did.
Dr. Jonathan Fuchs, who leads San Francisco County’s testing strategy at the Department of Public Health, confirmed that the partnership with Verily was “currently on hold.” He declined to provide further details.
In response to questions, Verily spokesperson Kathleen Parkes said the program requires users to register with Gmail accounts because Google’s authentication procedures safeguard sensitive data and protect “against unknown individuals sending or receiving information with serious consequences for health or well-being.” Conversations with San Francisco and Alameda remain “active,” Parkes said. The company did not respond to specific questions about the testing disparities cited by community leaders.
Verily’s role in COVID-19 testing has been shadowed by controversy since President Donald Trump told reporters at a Rose Garden news conference in March that “Google” was developing a screening website and testing tool. “Google has 1,700 engineers working on this right now,” he said. “They’ve made tremendous progress.”
At the time, COVID tests were in short supply and Trump was under pressure to increase capacity as infections ballooned in California, New York and other states. But Google was not building such a website. Instead, Verily, another Alphabet Inc. subsidiary focused on life sciences, was in the early stages of developing a website to help triage people in need of COVID testing, Google clarified in a tweet. It planned to unveil a pilot program in two Bay Area counties.
Days later, Newsom announced a California partnership with Verily that so far has paid the company $55 million to establish both mobile and brick-and-mortar testing sites. In addition, Verily has partnered with Rite Aid to manage testing at approximately 300 sites in multiple states under a $122.6 million federal contract between the pharmacy chain and the U.S. Department of Health and Human Services. California’s Verily contracts are in place through Nov. 30; the HHS contract is set to expire in January.
Participants in the Verily initiative sign an authorization form that says their information can be shared with multiple third parties involved in the testing program, including unnamed contractors and state and federal health authorities.
“While the form tells you that Verily may share data with ‘entities that assist with the testing program,’ it doesn’t say who those entities are. If one of those unnamed and unknown entities violates your privacy by misusing your data, you have no way to know and no way to hold them accountable,” said Lee Tien, senior staff attorney for the Electronic Frontier Foundation, a nonprofit that advocates for digital privacy.
The policy states Verily will not use the data collected for its own research or meld it with other Google products without the user’s permission. But it notes participants may be invited to share their data for such research, and the testing portal prominently features links inviting participants to sign up for other Verily research.
In California, as of Oct. 8, the Verily sites had processed an average of 1,583 patient samples per day over the prior seven days, according to the California Department of Public Health. Verily, the state health department and Alameda County all declined requests to provide race and ethnicity data by testing site.
Dr. Kim Rhoads, a UCSF professor and former colorectal surgeon who leads a COVID testing project for Black communities, said Aboelata’s experience with Verily is emblematic of widespread racial disparities in the testing and treatment of COVID-19. “We can’t keep talking about the consequences being unintended,” Rhoads said. “We are six months into this pandemic and anyone who is surprised by the repetitive findings of inequity in testing, the spread of virus and COVID-19 mortality just isn’t paying attention.”
In an interview, Ghaly, California’s health secretary, said he believed the state’s partnerships with Verily and other companies continue to be a national model for addressing problems with testing disparities, including setting up venues for minority and rural populations. For example, in counties in northern parts of the state, sometimes the only regular testing available was through mobile testing set up under the program, he said.
“I think there’s lots of success and lots of lessons learned and we continue to apply them,” Ghaly said. “Until the entire effort is completed, I always look at where we are as part success and part opportunity to keep learning.”
In a September response to the Oakland COVID-19 disparities task force, Ghaly outlined several actions the state had taken or would take in response to the concerns, including having Verily update its platform to include additional languages and work with testing vendors on alternative methods for data collection to address privacy concerns.
“Some of the things we learned specifically in our experience in Alameda and other parts of the Bay Area is language matters,” Ghaly told KHN.
After working with the homeless for 25 years, Dr. Margot Kushel, director of the UCSF Benioff Homelessness and Housing Initiative, said she wasn’t surprised to learn some community leaders ran into problems with Verily.
“It turns out that in public health, the highest-tech solution is usually not the right one,” she said. To bring COVID cases down, she explained, requires a “laser focus” on the highest-risk communities. And people in those communities often don’t want to turn over the protected information Verily asks for, whether because of fears about their immigration status or a history of mistrust of the medical establishment and policing.
“You can imagine a million and a half reasons why people would distrust it,” Kushel said. “The very structure of this is set up to fail. And by failing the communities who need it most, we fail everybody.”
California Healthline correspondent Angela Hart contributed to this report.
The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus.
This article was published on Monday, October 26, 2020 in Kaiser Health News.
COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits healthcare workers, ready reinforcements aren't easy to find.
In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state's capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.
"Just one more person out and we wouldn't be able to keep the surgeries going," said Dr. Shelly Harkins, chief medical officer of St. Peter's Health in Helena, a city of roughly 32,000 where cases continue to spread. "When the virus is just all around you, it's almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye."
In North Dakota, where cases per resident aregrowing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.
"How long can we run at this rate with the workforce that we have?" Blasl said. "You can have all the licensed beds you want, but if you don't have anybody to staff those beds, it doesn't do you any good."
The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a seven-day period, according to an analysis by The New York Times.
Such coronavirus infections — and the quarantines that occur because of them — are exacerbating the healthcare worker shortage that existed in these states well before the pandemic. Unlike in the nation's metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states' biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.
Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter's Health, if the hospital's one kidney doctor gets sick or is told to quarantine, Harkins doesn't expect to find a backup.
"We make a point to not have excessive staff because we have an obligation to keep the cost of healthcare down for a community — we just don't have a lot of slack in our rope," Harkins said. "What we don't account for is a mass exodus of staff for 14 days."
Some hospitals are already at patient capacity or are nearly there. That's not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don't pause for a pandemic.
Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast — and widely — the hope is that their needs don't peak all at once.
Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn't brought in new workers.
"If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team," Bullock said.
This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelinesfor health facilities facing staffing shortages.
"That's very telling for what staffing is going through right now," said Andrea Lueck, a registered nurse at the center. "We're so tight that employees are called off of quarantine."
Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state's second-highest number of active COVID-19 cases.
Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.
But Sharpton said the best way to conserve the hospital's workforce is to stop the disease surge in the community.
Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren't worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn't find housing. And, so far, roughly 40 of the hospital's 322 employees have missed work for reasons connected to COVID-19.
"We're at a critical staffing shortage and have been since the beginning of COVID," said Joanie Slaybaugh, Central Montana Medical Center's director of human resources. "We're small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn't take much to take out our staff."
Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation's highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that's ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Presser can't find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.
"I need someone to do immunizations for my community, and you don't become an immunization nurse in 14 days," Presser said. "We don't have the workforce here to deal with this virus, not even right now, and then I'm going to have my best two people go."
Back in Helena, Harkins said St. Peter's Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.
Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won't help for some specialties, like the hospital's sole kidney doctor.
Every time Harkins' phone rings, she said, she takes a breath and hopes it's not another case that will force a whole division to close.
"Because I think immediately of the hundreds of people that need that service and won't have it for 14 days," she said.
Mountain States editor Matt Volz contributed to this story.
Florida's plan to import cheaper prescription drugs from Canada — designed by Gov. Ron DeSantis and endorsed by President Donald Trump — has tasted its first bitter pill.
No private firms bid on Florida's $30 million contract to set up and operate a drug importation program. Bids were due at the end of September.
The setback is likely to delay by at least several months Florida's effort to become the first state to import drugs.
A spokesperson for the Florida Agency for Healthcare Administration said the state is exploring its options. "The agency remains confident it will find a qualified vendor soon," the spokesperson said. The state had planned to award a contract to a private vendor in December.
The disclosure of no bidders comes less than a month after the Trump administration cleared the way for states to apply for federal permission to set up an importation program — reversing nearly two decades of U.S. policy.
A 2003 law allows drug importation from Canada, but only if the head of the federal Department of Health and Human Services deems it safe and cost-effective. HHS Secretary Alex Azar made that declaration Sept. 24 and approved final rules for such initiatives.
Jane Horvath, a health consultant in College Park, Maryland, said potential bidders on the Florida contract were likely put off because the final federal rules were not set until late September. And private firms didn't want to bid on a contract that would have to change if the Florida rules conflicted with those from Washington, she said.
Several inconsistencies are apparent between the Florida plan and what is allowed under the HHS final rules, she said. For example, Florida aims to give bonus-scoring points to contractors that repackage and relabel drugs in Florida, which is not allowed under the federal rules.
Another problem is that the private contractor has to determine which prescription drugs will produce the most savings for Florida's Medicaid program, which is difficult since Medicaid rebates and other discount pricing are confidential.
"It could be that the $30 million contract is not enough either," Horvath said.
Drug prices are lower in Canada because the country limits how much drugmakers can charge for medicines. The United States lets drugmakers and their distributors dictate prices.
Trump, who made lowering prescription drug prices a key campaign issue in 2016, has promoted importation, especially in messages geared to seniors during his reelection bid.
Even with HHS backing, drug importation faces several challenges. Most notably, Canada has vowed to stop any effort that would exacerbate drug shortages there, which could make it challenging to identify a Canadian exporter. And the pharmaceutical industry opposes the program and is likely to sue to stop it.
Florida plans to set up an importation program to help lower drug prices for people covered by state programs such as Medicaid and the Corrections Department. The state has projected savings of up to $150 million a year.
The federal rules take effect Nov. 30, which is when states can formally apply to HHS to set up their program.
A chief architect of Florida's importation plan, Mary Mayhew, who was secretary of the Florida Agency for Healthcare Administration, resigned in September to become CEO of the Florida Hospital Association.
Mayhew refused to comment for this story.
Vermont, Colorado, Maine, New Hampshire and New Mexico are also devising programs to import drugs from Canada.
Colorado officials plan to seek out private contractors for that state's program in 2021, and they hope to get final federal approval by summer 2022, officials said during a recent call with stakeholder groups.
Colorado plans to allow consumers to get drugs from Canada at their U.S. pharmacy or through mail order. It estimates residents could save an average of 61% off the price of medicines in Colorado today.
It's unclear what impact the outcome of the presidential election will have on drug importation. Democratic nominee Joe Biden said he supports importing drugs from Canada. But, if elected, he is also likely to review many of the Trump administration's actions.
Dale Folwell has tried to persuade hospitals to accept lower payments, but he has struggled to discover the existing rates the plan pays each hospital.
This article was published on Monday, October 26, 2020 inKaiser Health News.
Cartel is a term frequently associated with illegal narcotics syndicates. In North Carolina, it has become the favored word of State Treasurer Dale Folwell to describe the state's hospital industry, the antagonist in his quest to lower healthcare prices for state employees.
The treasurer manages the state employees' health plan, which insures about 727,000 teachers, police officers, current and retired state workers and dependents. Folwell, a Republican, has tried to persuade hospitals to accept lower payments, but he has struggled to discover the existing rates the plan pays each hospital.
"These organizations' business model is secrecy," Folwell said, "from the billing all the way up to the way these hospitals' organizations receive their tax-exempt status."
Now, as Folwell, 62, seeks a second four-year term, the state's hospitals are coming after him.
The North Carolina Healthcare Association, the hospital trade group, has endorsed Folwell's Democratic challenger. It is a rare instance of a healthcare lobby seeking to topple an incumbent. Over 26 years, North Carolina's hospital association donated $2.1 million to sitting officeholders but bestowed just $29,700 to challengers, according to a tally from the National Institute on Money in Politics, a Montana-based nonprofit. All donations made this year will not be fully disclosed until after the election.
In many states, hospital associations are political powerhouses, with stables of lobbyists and the influence that comes with often being the largest employer in many legislative districts. In the previous election cycle of 2018, the hospital industry across the country donated $71 million to local and state candidates, political parties and ballot initiatives, according to the Money in Politics data. That amounted to a fifth of all spending by the healthcare industry and nearly three times that spent by pharmaceuticals and health products companies.
"The hospitals have very strong political clout in North Carolina, and increasingly so as they get bigger," said Aaron McKethan, a resident scholar at the Margolis Center for Health Policy at Duke University's Fuqua School of Business. "They are huge sources of employment. If anything, COVID has reinforced and strengthened them — the job of wagging your finger at hospitals over their prices has gotten harder."
Nationally, hospitals account for a third of healthcare spending. The prices hospitals charge private insurers including the state health plan are driving much of the increase in healthcare premiums. In North Carolina, hospital inpatient prices for private insurers rose by 10% from 2014 to 2018, according to the Healthcare Cost Institute.
Folwell's critics complain that, despite his verbal provocations about hospital power, his efforts to transform healthcare pricing have mostly fizzled. They also lament that he has made no effort to try to persuade the legislature to expand Medicaid, which would help shore up hospital finances.
"The treasurer has, for some reason, insisted on taking a 'my way or the highway' approach, rather than engage in honest conversations and negotiations," Cynthia Charles, the hospital association's spokesperson, said in an email. "As we have repeatedly said, we are willing to work together to redesign the plan in a manner to advance goals for cost reductions, price transparency and provider inclusion."
Folwell's Democratic challenger, Ronnie Chatterji, and the hospital industry insist a better way to bring health costs under control would be to tie payments to the quality of care, an approach Blue Cross and Blue Shield of North Carolina has begun experimenting with. With blunt cuts, "you're just going to put people's healthcare access in jeopardy," said Chatterji, an economist at the Fuqua School who served on former President Barack Obama's Council of Economic Advisers.
The bad blood between Folwell and North Carolina hospitals primarily traces back to 2018, when the treasurer told hospitals, doctors and other medical providers that to avoid having to ask the legislature for more money or raise employee contributions, he wanted to reduce by $300 million the amount the $3.3 billion health plan paid medical providers each year.
Folwell proposed to base prices on Medicare rates, an approach known as reference pricing. His plan offered to pay most hospitals 175% of what Medicare reimbursed them for inpatient services and 225% for outpatient services, on average. Rural hospitals, which tend to be in worse financial shape, would have received more, but their rates would also have been pegged to Medicare.
The plan would have amounted to a pay cut for most hospitals. A recent Rand Corp. study of hospital prices found that North Carolina hospitals in 2018 were paid on average 221% of Medicare rates for inpatient services and 334% of Medicare rates for outpatient services — well above what the treasurer was proposing.
The state's two big nonprofit systems, Atrium Health and Novant Health, earned substantially more, according to the Rand data. For example, Atrium Health Mercy hospital in Charlotte collected 423% of Medicare outpatient prices. Forsyth Medical Center in Winston-Salem, owned by Novant, collected 377% of what Medicare paid for outpatient services.
In its newsletter, the hospital association told its members that it tried to negotiate with the treasurer but that "Folwell has responded with disinterest and hostility towards these overtures and is instead engaging in a public campaign to malign hospitals."
The hospitals warned customers that if no agreement could be reached with the state plan, the hospitals would be classified as out-of-network providers and state employees would end up having to pay far more for their services.
Those arguments about financial penury obscured the fact that North Carolina's major hospital systems run huge surpluses in most years. Financial disclosure documents show that Atrium, which owns 36 hospitals in the state, ended 2019 with a$370 million surplus, a 6% margin. Novant, which owns 12 hospitals in North Carolina, that year earned $155 million, a 3% margin.
UNC Health, which amassed $271 million — a 6.4% margin — in its 2019 fiscal year, said in a statement that the treasurer's plan would have cost it $47 million in its 2020 fiscal year and "jeopardized the financial viability of some of our rural hospitals."
"We're overpaying for no reason but to build multimillion reserves for these hospital corporations," said Ardis Watkins, executive director of the State Employees Association of North Carolina.
Ultimately, the hospitals maintained a solid wall of opposition. Only three of North Carolina's 108 hospitals signed on to the treasurer's plan.
Duke's McKethan said it was "predictable" that the hospitals would refuse to give up the negotiating advantages they held. "On the diagnosis of the problem — we've got these opaque prices that vary — he's on solid ground," he said about Folwell. "But when a good idea runs into the disadvantageous structure of the healthcare market, it doesn't go anywhere."
Apart from hospitals, the treasurer had some success in persuading about 25,000 of the state's 60,000 doctors, therapists and other medical providers to accept the new payment system, which he named the Clear Pricing Project. Dr. Dale Owen, CEO of Tryon Medical Partners, a large independent physicians' group based in Charlotte, said his group's reimbursements will come out about the same under the plan.
"Quite honestly, even if it had been a tiny loss, no big deal because it was the right thing to do for everybody," said Owen, who formed his group with fellow physicians who seceded from Atrium. "What he's doing is, he's opening a sore and a problem that people have not been willing to deal with and pushed under the rug."
The Clear Pricing Project has yet to demonstrate the ability to save the state money. In fact, the effort may be costing the state more because many of the providers that signed on — such as primary care doctors and behavioral health specialists — are getting higher reimbursements than they had been while those that would have lost money, like hospitals, have stayed away.
Asked why he thought the hospitals would volunteer to forgo higher payments, Folwell said he had hoped they would realize that their long-term survival is endangered by the unsustainable increase in healthcare costs.
"I thought they would want to be partnering with a solution instead of the same old way," he said in an interview. "I don't think they accept the notion that they're going to be on the wrong side of history."
The hospital industry has been taking steps to try to make Folwell and his proposal history. During his attempt to get hospitals to agree to the pricing plan, the industry's allies in the legislature introduced a billthat would have blocked the state health plan from instituting any reference pricing plan through 2021. That effort ultimately died.
Folwell has continued to rankle the hospitals with his opposition to further concentration of hospital ownership. He has opposed the pending sale of a county-owned hospital based in Wilmington, which Novant is purchasing. That followed his 2018 attempt to challenge an ultimately unsuccessful merger of Atrium and UNC Health by requesting a $1 billion performance bond if the deal ultimately raised prices for the state health plan.
Last month, the hospital association gave Chatterji its endorsementwith a clear swipe at Folwell. The association's president, Steve Lawler, said in the statement that "it is apparent that Mr. Chatterji genuinely wants to collaborate."
It’s no surprise, then, that in an ad released this month, former Vice President Joe Biden’s campaign played the Medicare card.
“Donald Trump is lying about Medicare and Social Security,” an ominous, mature, male voice warns viewers in the ad. He goes on to say that “Trump’s pushing to slash Medicare benefits.”
Clearly, we’ve heard this dire message before — from candidates of both parties through the years.
We issued a skeptical rating of a claim that Trump promised to gut Social Security and Medicare if re-elected, noting that his deferral of payroll taxes did not mention Medicare at all. But Trump has not mentioned cuts to Medicare benefits on the trail, and he’s promised to make cuts to the program in the future. So what is Biden’s claim talking about?
As a rationale for the statement, a Biden campaign spokesperson pointed us to the Trump administration’s support of Republicans’ efforts in a court case, California v. Texas, which seeks to overturn the Affordable Care Act. But the ad does not include any reference or explanation of how the case would affect Medicare benefits.
The legal challenge, brought by a group of Republican attorneys general, is pegged to the 2017 tax bill, which zeroed out the tax that functioned as a penalty for not having health coverage — known as the individual mandate. Without this linchpin tax, the Republicans argue, the entire law should be struck down. They based that on the Supreme Court decision in 2012 that the law was constitutional because the penalty was a valid use of Congress’ ability to levy taxes.
In the current case, lower courts have found the law unconstitutional, and a group of Democratic attorneys general appealed to the Supreme Court.
Oral arguments are scheduled for Nov. 10. The Trump administration filed a brief in support of invalidating the entire law unconstitutional.
Though best known for its vast expansion of health coverage through marketplace plans and Medicaid, the ACA also included a range of consumer protections — such as the ban on discrimination against people with preexisting conditions — and an estimated 165 Medicare-related provisions.
The Biden spokesperson pointed to one, which ended Medicare’s so-called doughnut hole.
We asked experts for their take. Immediately, we found differences in opinion.
That’s a “perfectly fair claim,” said Nicholas Bagley, a professor at the University of Michigan Law School. Closing the doughnut hole matters to many people, he said.
Case Western Reserve University law professor Jonathan Adler took a different view. The argument that Medicare would be affected “is a very aggressive reading of the filing in this case,” he said, referring to the Trump administration’s brief in support of nullifying the ACA.
The next step seemed to be getting a better grasp of what’s at stake.
A Quick Review of the Doughnut Hole, Other Medicare Provisions
The Medicare doughnut hole refers to the gap in Part D prescription drug coverage that begins after a beneficiary spends a set amount — usually a few thousand dollars. Before the ACA, beneficiaries who reached that threshold were responsible for 100% of their medication costs until they spent enough for catastrophic coverage to kick in, which could be more than $1,000 in additional spending. Even with this coverage, beneficiaries were responsible for 5% of their drug expenditures. (If beneficiaries were responsible for 100% of costs today, people with high drug costs would obviously pay a lot more without the ACA provision.)
The ACA would have gradually ended that coverage gap. But, in 2018, Congress adopted changes to expedite the process. As of 2019, the doughnut hole was closed. Adler pointed to that congressional intervention as a step that could keep the doughnut hole closed if the ACA were overturned. Based on this legislative history, the argument could be made that closing the coverage gap was something Congress had an interest in apart from the ACA. Since the doughnut hole is officially closed, some analysts said this provision may not be vulnerable to the upcoming Supreme Court decision on the ACA.
“You can make a lot of claims,” said Gail Wilensky, a former head of the Centers for Medicare & Medicaid Services. “That one is really a stretch.”
Other ACA provisions tied to Medicare benefits seem more at risk, such as the one that mandated annual wellness visits and certain preventive services, such as mammograms, bone mass measurement for those with osteoporosis, and depression and diabetes screening, with no patient cost sharing.
“It’s not clear that the administration actively supports any change to the Medicare benefits with the case before SCOTUS,” said Tricia Neuman, KFF senior vice president and executive director of the KFF’s program on Medicare policy. “But if they didn’t explicitly seek to wall off certain provisions, it is at least conceivable — though maybe not likely — that Medicare benefits in the ACA could be collateral damage.” (KHN is an editorially independent program of KFF.)
According to an amicus brief filed by the AARP, the Center for Medicare Advocacy and Justice in Aging in 2016, an estimated 40.1 million Medicare beneficiaries received at least one preventive service and 10.3 million had an annual wellness visit with no copay or deductible.
Other experts pointed to a troubling implication for Medicare: the nullification of the ACA provisions related to costs and slowing the growth of the program’s spending. Those efforts had been credited with extending the solvency of the Health Insurance Trust Fund and slowing the growth in Medicare premiums.
It “would impair the financial fitness” of the trust fund, said Paul Van de Water, a senior fellow at the Center on Budget and Policy Priorities.
Trump “may not say it is his intent to slash Medicare benefits,” agreed David Lipschutz, associate director of the Center for Medicare Advocacy, but overturning the ACA entirely would “cause chaos writ large.” And, because of the program’s size, that chaos “would upend the financial markets and the entire health care system,” according to the brief filed by Medicare advocates.
What Comes Next Is Complicated
Enter the concept of severability. Many court watchers are quick to say the high court’s decision could go beyond upholding the entire law or declaring it unconstitutional. Instead, the justices could separate or sever parts of it not directly related to the zeroed-out tax penalty, the so-called individual mandate.
Of course, the Trump administration argued in its brief that the interwoven nature of the ACA’s provisions demanded that the entire law be invalidated.
“If you just go on that basis, they are not arguing for severability,” said Van de Water.
But others point out another layer that warrants consideration.
“Everyone who comments on this focuses on the administration’s argument for inseverability,” Adler said. But he said it was more complicated than that.
The Trump administration’s position is “simultaneously that the entire ACA should be invalidated” and also that relief should be provided only where injury to the plaintiffs is shown. (The administration defines the plaintiffs as the two individuals who signed on to the original challenge.)
Another view is that this point in the administration’s argument is not clear-cut, mostly because it gives no hint as to which programs or provisions would fit into the category of harming the plaintiffs.
Ultimately, the fate of the sweeping health law is in the hands of the Supreme Court.
“Legal analysts didn’t anticipate the case getting as far as it has,” said Lipschutz.
But “the White House threw its weight behind the lawsuit,” said Bagley, at the University of Michigan. “So, they own the consequences. Especially in the context of this presidential campaign.”
Our Ruling
An attack ad by the Biden campaign states that Trump is “pushing to slash Medicare benefits” and ties this charge to the administration’s position on the pending legal challenge to the ACA.
The Biden campaign pointed to an ACA provision that sought to close the Medicare doughnut hole to support this claim. It may not be the best example, though, because some experts suggest it may not be as vulnerable as other parts of the law.
Experts outlined a range of other Medicare provisions that either provided new benefits or shored up the program’s financial fitness. If the whole law were to be nullified, as the administration has advocated, these changes could also be erased — a step that would affect benefits and potentially cause premiums to rise.
Overall, the Biden ad seems plausible, even though the link between Trump’s position on the legal challenge and its impact on Medicare benefits is less straightforward than in similar claims we have checked regarding preexisting conditions.
During the final presidential debate, President Donald Trump claimed that 180 million people would lose their private health insurance to socialized medicine if the Democratic presidential nominee, former Vice President Joe Biden, is elected president.
“They have 180 million people, families under what he wants to do, which will basically be socialized medicine — you won’t even have a choice — they want to terminate 180 million plans,” said Trump.
Trump has repeated this claim throughout the week, and we thought the linkage of Biden’s proposed health care plan with socialism was something we needed to check out. Especially since Biden opposed “Medicare for All,” the proposal by Sen. Bernie Sanders (I-Vt.) that would have created a single-payer health system run completely by the federal government, and has long been attacked by Republicans as “socialist.”
The Trump campaign did not respond to our request asking where the evidence for this claim came from. Experts called it a distortion of Biden’s plan.
Where the Number Comes From
Experts agreed the number of people who have private health insurance either through an employer-sponsored plan or purchased on the Affordable Care Act’s health insurance marketplace is around 180 million people.
KFF, a nonpartisan health policy organization,estimated in 2018 that about 157 million Americans had health insurance through their employer, while almost 20 million had insurance they purchased for themselves. Together, that adds up to about 177 million with private health insurance. (KHN is an editorially independent program of KFF.)
What Does Biden Support?
Biden supports expanding the ACA through several measures, including a public option. Under his plan, this public option would be a health insurance plan run by the federal government that would be offered alongside other private health insurance plans on the insurance marketplace.
“The marketplace is made up of multiple insurers in areas,” said Linda Blumberg, a health policy fellow at the Urban Institute. “Sometimes there are five or more [plans]; sometimes there is only one. Biden is talking about adding a public option in the marketplace. You could pick between these private insurers or you could pick the public option.”
Getting rid of the so-called employer firewall is also part of Biden’s proposal.
This firewall was implemented during the rollout of the ACA. It was designed to maintain balance in the insurance risk pools by preventing too many healthy people who have work-based coverage from opting instead to move to a marketplace plan. And it all came down to who qualified for the subsidies that made these plans more affordable.
Currently, those who are offered a health insurance plan through their employer that meets certain minimum federal standards aren’t eligible to receive these subsidies, which come in the form of tax credits. But that leaves many low-income workers with health care plans that aren’t as affordable or comprehensive as marketplace plans.
Biden’s plan would eliminate that firewall, meaning anyone could choose to get health insurance either through their employer or through the marketplace. That’s where many Republicans argue that we could start to see leakage from private health insurance plans to the public option.
“The problem is healthy people leaving employer plans,” said Joseph Antos, a scholar in health care at the conservative-leaning American Enterprise Institute. That could mean the entire workplace plan’s premiums would go up. “You could easily imagine a plan where it spirals, the premiums go up, and then even more people start leaving the plans to go to the public option.”
Blumberg, though, said that because the marketplace would still include private health insurance plans alongside the public option, it doesn’t mean everyone who chooses to leave their employer plan would go straight to the public option.
She has done estimatesbased on a plan similar to the one Biden is proposing. She estimates that only about 10% to 12% of Americans would choose to leave their employer-sponsored plans, which translates to about 15 million to 18 million Americans.
Source List:
Email interview with Cynthia Cox, vice president and director for the Program on the ACA at KFF, Oct. 22, 2020
Email interview with Larry Levitt, executive vice president for health policy at KFF, Oct. 22, 2020
Email interview with Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University, Oct. 22, 2020
Phone interview with Joseph Antos, Wilson H. Taylor resident scholar in health care and retirement policy at the American Enterprise Institute, Oct. 22, 2020
Phone interview with Linda Blumberg, institute fellow in the Health Policy Center at the Urban Institute, Oct. 22, 2020
KFF also did an estimate and found that 12.3 million people with employer coverage could save money by buying on the exchange under the Biden plan.
But “it’s not clear all of those people would choose to leave their employer coverage, though, as there are other reasons besides costs that people might want to have job-based insurance,” Cynthia Cox, vice president and director of the program on the ACA at KFF, wrote in an email.
Either way, none of the estimates are anywhere close to the 180 million that Trump claimed.
Is This Type of Public Option Socialism?
Overall, experts said no, what Biden supports isn’t socialized medicine.
“Socialized medicine means that the government runs hospitals and employs doctors, and that is not part of Biden’s plan,” Larry Levitt, executive vice president for health policy at KFF, wrote in an email. “Under Biden’s plans, doctors and hospitals would remain in the private sector just like they are today.”
However, Antos said that, in his view, the definition of socialism can really vary when it comes to health care.
“I would argue in one sense, we would already have socialized medicine. We have massive federal subsidies for everybody, so in that sense, we’re already there,” said Antos. “But, if socialized medicine means the government is going to dictate how doctors practice or how health care is delivered, we are obviously not in that situation. I don’t think the Biden plan would lead you that way.”
And in the end, Antos said, invoking socialism is a scare tactic that politicians have been using for years.
“It’s just a political slur,” said Antos. “It’s meant to inflame the emotions of those who will vote for Trump and meant to annoy the people who will vote for Biden.”
Our Ruling
Trump said 180 million people would lose their private health insurance plans to socialized medicine under Biden.
While about 180 million people do have private health insurance, there is no evidence that all of them would lose their private plans if Biden were elected president.
Biden supports implementing a public option on the health insurance marketplace. It would exist alongside private health insurance plans, and Americans would have the option to buy either the private plan or the public plan. While estimates show that a number of Americans would likely leave their employer-sponsored coverage for the public plan, they would be doing that by choice and the estimates are nowhere near Trump’s 180 million figure.
Experts also agree that the public option is not socialized medicine, and it’s ridiculous to conflate Biden’s plan with Medicare for All.