Lobbyist used their political clout and close ties with the governor to devise a friendlier alternative that doctors, hospitals and insurance companies could live with.
This article was published on Wednesday, October 13, 2021 in Kaiser Health News.
SACRAMENTO — Gavin Newsom put California's healthcare industry on notice when he was a candidate for governor, vowing in 2018 to go after the insurance companies, doctors and hospitals that leave many Californians struggling with enormous medical bills and rising insurance premiums.
He pledged to lead California's single-payer movement, a high-stakes liberal dream that would eliminate private health insurance and slash how much providers are paid. The tough rhetoric continued after he was elected, when Newsom told insurers to "do their damn job" to improve mental health treatment or face fines, and he vowed to cut the healthcare industry's soaring revenues.
"We've got to get serious about reducing healthcare costs," the first-term Democrat said in January 2020 as he unveiled his proposal to establish an Office of Healthcare Affordability that would do the unthinkable in a system powered by profits: set caps on healthcare spending and require doctors and hospitals to work for less money. "We mean business."
Industry leaders were rattled. But rather than mobilize a full-throttle defense to sink Newsom's effort to regulate them, they have used their political clout and close ties with the governor to devise a friendlier alternative that doctors, hospitals and insurance companies could live with.
When Newsom ultimately drafted legislation for the office, he took an idea healthcare executives had pitched and made it his own: Instead of capping prices or cutting revenues, he would allow industry spending to grow — but with limits.
Political infighting killed the legislation this year, but it is expected to come back in January and spark one of next year's blockbuster healthcare battles.
"They're fearful of what might happen to them, and they're trying to protect their interests because they're threatened," David Panush, a veteran Sacramento health policy consultant, said about healthcare industry players. They know "there's blood in the water and the sharks are coming."
If Newsom's plan to rein in healthcare spending succeeds, it could provide him some political cover as he campaigns for reelection next year, giving him a major healthcare win even as he sidesteps progressive demands such as creating a single-payer system.
But it could also cement the power of an industry that continues to wield immense influence — negotiating behind the scenes to protect its massive revenues and secure exemptions and side deals in exchange for its support.
"Every time we try to do something to reduce healthcare costs, it meets with huge opposition," said state Assembly member Jim Wood (D-Santa Rosa), head of the Assembly Health Committee, who is working closely with the Newsom administration on this proposal.
Industry power players have only pushed back harder as lawmakers have tried to take them on, Wood said. "Anybody or anything that disrupts the status quo is met with huge resistance and huge resources to fight it," he said.
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When Newsom took office in 2019, he knew public sentiment was turning against the healthcare industry. On average, healthcare costs were around $11,600 per person that year, up from $4,600 in 1999, according to federal data. In California, hospitals account for the biggest share of spending, nearly one-third, while 20% of healthcare dollars goes to doctors.
California consumers are demanding action, with 82% of state residents saying it's "extremely" or "very" important for the governor and legislature to make healthcare more affordable, according to a 2021 poll from the California Healthcare Foundation.
Much of Newsom's tough talk on industry spending came early in his term. "We're going to create specific cost targets for all sectors to achieve, and we are going to assess penalties if they don't achieve those targets," Newsom said in January 2020. "If that didn't wake up members of the system, I don't know what will."
Newsom's wake-up call came on the heels of tense legislative debates on bills that would have empowered the state to set healthcare prices and created a single-payer system. The measures gained surprising momentum but ultimately buckled under opposition from healthcare giants.
Then the COVID-19 crisis hit and propelled the recall effort to oust him from office — and the wake-up call was met with a slap of the snooze button. The governor and his health industry allies nestled closer. Just as he needed them to be the state's front line of defense, they needed him to keep hospitals from overflowing, to secure protective gear and to push vaccinations.
Healthcare titans became regular fixtures in Newsom's orbit. His calendars, obtained by KHN, show that doctors, hospitals and health insurance leaders have routinely received access to the governor.
Carmela Coyle, head of the California Hospital Association, stood beside Newsom at the state emergency operations center in the early days of the COVID crisis, and Paul Markovich, CEO of Blue Shield of California, obtained a lucrative no-bid state vaccination contract to implement Newsom's vaccination effort.
The coziness of the industry's relationship with Newsom burst into public view in late 2020 when he was photographed dining at the ritzy French Laundry restaurant with Dustin Corcoran and Janus Norman, the CEO and top lobbyist, respectively, of the state doctors' lobby, the California Medical Association.
"There is no possible way we could have come out of this COVID crisis where the healthcare industry was given so much power without influence coming along with that," said Carmen Balber, executive director of the advocacy group Consumer Watchdog.
Newsom did not respond to questions about the industry's influence, but spokesperson Alex Stack said his proposal to regulate healthcare spending "is a priority for this administration, and we look forward to continuing to work on this issue to get it done."
Doctors and Blue Shield have given Newsom millions of dollars to support his political career over many years, including a $20 million donation in September 2020 from Blue Shield for his homelessness initiatives.
The recall effort earlier this year only solidified Newsom's relationship with healthcare executives. Industry groups wrote checks to the California Democratic Party, which fought to keep Newsom in office. It received $1 million each from Blue Shield and the hospital lobby and $875,000 from the doctors' lobby, according to state campaign finance records.
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Though Newsom vowed to go after the industry, he hasn't aggressively taken it on, and healthcare executives and lobbyists continue to wield their influence as they shape the debate over the Office of Healthcare Affordability.
That could put Newsom in a political bind as he runs for reelection — first in the June 2022 primary and then the November general election — because he will face intense opposing political pressure from liberal Democrats who want him to keep his campaign promise and adopt single-payer.
Health and political experts say Newsom can help alleviate that pressure by adopting a strict law going after spiraling healthcare spending.
"This issue isn't going away — it does need to be addressed," acknowledged Corcoran. The push to control costs "should be uncomfortable for everybody, but not horribly so."
But it won't be easy. After powerful industry leaders joined forces with organized labor and consumer advocates to propose a plan to the governor, they jammed negotiations with their demands, splintering the coalition and killing the effort this year.
Coyle, with the hospital association, had left the coalition early out of concern that hospitals were the primary target, and approached the Newsom administration independently. She is also asking Newsom to relax stringent earthquake safety standards for hospitals.
Corcoran wants to exempt "small" doctor practices — which he defines as practices with up to 100 doctors — from regulation, arguing that restrictive government cost controls could put them out of business, leading to increased industry consolidation and higher prices.
"The goal posts were constantly shifting," said Yasmin Peled, a lobbyist for the advocacy group Health Access California, which was involved in negotiations. "The asks were constantly changing."
Before negotiations completely broke down, Newsom embraced the idea floated by Coyle: The state should control growth, not impose revenue cuts. And it should not focus only on hospitals, but apply to all healthcare sectors, including doctors and insurers. (The pharmaceutical industry would not be subject to the cost control provisions of the measure because of restrictions in federal law, according to Wood's office.)
With battle lines drawn, industry groups are poised for a major fight next year as Newsom and state Democratic lawmakers muscle through legislation. Their primary goal will be to protect their interests, said Mark Peterson, a professor of public policy, political science and law at UCLA.
"There's no question this industry has power. The real question is what they do with it," Peterson said. "They're getting wins, and important ones."
My primary care doctor and I were saying goodbye after nearly 30 years together.
"You are a kind and a good person," he told me after the physical exam, as we wished each other good luck and good health.
"I trust you completely — and always have," I told him, my eyes overflowing.
"That means so much to me," he responded, bowing his head.
Will I ever have another relationship like the one with this physician, who took time to ask me how I was doing each time he saw me? Who knew me from my first months as a young mother, when my thyroid went haywire, and who since oversaw all my medical concerns, both large and small?
It feels like an essential lifeline is being severed. I'll miss him dearly.
This isn't my story alone; many people in their 50s, 60s and 70s are similarly undergoing this kind of wrenching transition. A decade from now, at least 40% of the physician workforce will be 65 or older, according to data from the Association of American Medical Colleges. If significant numbers of doctors retire, as expected, physician shortages will swell. Earlier this year, the AAMC projected an unmet need for up to 55,200 primary care physicians and 86,700 specialists by 2033, amid the rapid growth of the elderly population.
Stress from the COVID pandemic has made the outlook even worse, at least in the near term. When the Physicians Foundation, a nonprofit research organization, surveyed 2,504 doctors in May and June, 61% reported "often experiencing" burnout associated with financial and emotional strain. Two percent said they had retired because of the pandemic; another 2% had closed their practices.
Twenty-three percent of the doctors surveyed said they'd like to retire during the next year.
Baby boomers, like me, whose medical needs are intensifying even as their longtime doctors bow out of practice, are most likely to be affected.
"There's a lot of benefit to having someone who's known your medical history for a long time," especially for older adults, said Dr. Janis Orlowski, AAMC's chief healthcare officer. When relationships with physicians are disrupted, medical issues that need attention can be overlooked and people can become less engaged in their care, said Dr. Gary Price, president of the Physicians Foundation.
My doctor, who's survived two bouts of cancer, didn't mention the pandemic during our recent visit. Instead, he told me he's turning 75 a week before he closes the practice at the end of October. Having practiced medicine for 52 years, 40 as a solo practitioner, "it's time for me to spend more time with family," he explained.
An intensely private man who's averse to publicity, he didn't want his name used for this article. I know I'm lucky to have had a doctor I could rely on with complete confidence for so long. Many people don't have this privilege because of where they live, their insurance coverage, differences in professional competence, and other factors.
With a skeletal staff — his wife is the office manager — my doctor has been responsible for 3,000 patients, many of them for decades. One woman sobbed miserably during a recent visit, saying she couldn't imagine starting over with another physician, he told me.
At one point, when my thyroid levels were out of control, I saw my physician monthly. After my second pregnancy, when this problem recurred, I brought the baby and her toddler brother in a double stroller into the exam room. One or the other would often cry sympathetically when he drew my blood.
I remember once asking when a medical issue I was having — the flu? a sore throat? — would resolve. He pointed upward and said, "Only Hashem knows." A deeply religious man, he wasn't afraid to acknowledge the body's mysteries or the limits of medical knowledge.
"Give it a few days and see if you get better," he frequently advised me. "Call if you get worse."
At each visit, my doctor would open a large folder and scribble notes by hand. My file is more than 4 inches thick. He never signed up for electronic medical records. He's not monetizing his practice by selling it. For him, medicine was never about money.
"Do you know the profit margins this hospital makes?" he asked at our last visit, knowing my interest in healthcare policy and finance. "And how do you think they do it? They cut costs wherever they can and keep the nursing staff as small as possible."
Before a physical exam, he'd tell a joke — a way to defuse tension and connect with a smile. "Do you know the one about …" he'd begin before placing his fingers on my throat (where the thyroid gland is located) and squeezing hard.
Which isn't to say that my doctor was easygoing. He wasn't. Once, he insisted I go to the emergency room after I returned from a long trip to South Asia with a very sore leg and strange pulsing sensations in my chest. An ultrasound was done and a blood clot discovered.
The young doctors in the ER wanted to give me intravenous blood thinner and send me home with a prescription. My doctor would have nothing of it. I was to stay in the hospital overnight and be monitored every few hours, efficiency and financial considerations be damned. He was formidable and intransigent, and the younger physicians backed down.
At that last meeting, my doctor scribbled the names of two physicians on a small sheet of paper before we said our goodbyes. Both would take good care of me, he said. When I called, neither was accepting new patients. Often, I hear this from older friends: They can't find physician practices that are taking new patients.
Price, who's 68, went through this when his family physician announced she was retiring and met with him in January to work out who might take over his care. Price was admitted into the practice of a younger physician with a good reputation only because he asked a medical colleague to intervene on his behalf. Even then, the first available appointment was in June.
Orlowski had a similar experience two years ago when searching for a new primary care doctor for her elderly parents. "Most of the practices I contacted weren't accepting new patients," she told me. It took six months to find a physician willing to see her parents — again, with the help of medical colleagues.
I'm lucky. A friend of mine has a physician daughter, part of an all-women medical practice at a nearby university hospital. One of her colleagues had openings and I got on her schedule in December. My friend's daughter recommends her highly.
Still, it will mean starting over, with all the dislocation that entails. And these transitions are hard, for patients and doctors alike.
Several weeks ago, I received a letter from my doctor, likely his last communication, which I read with a lump in my throat.
"To my beloved patients," he wrote. "I feel so grateful for the opportunity to treat you and develop relationships with you and your families that I will always treasure. … I bid you all adieu. I hope and pray for your good health. I will miss each and every one of you and express to you my appreciation for so many wonderful years of doing what I love, caring for and helping people."
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 healthcare system. Visit khn.org/columnists to submit your requests or tips.
A widespread practice requires patients with alcoholic liver disease to complete a period of sobriety before they can get on the waiting list for a liver.
This article was published on Tuesday, October 12, 2021 in Kaiser Health News.
When he arrived at the rehab facility in North Kansas City, Missouri, they sent him directly to the adjoining hospital. There, Gorzney, then 50, and his family learned he had severe alcoholic hepatitis, an inflammation of the liver typically associated with excessive alcohol use.
Gorzney had been drinking heavily on and off for years and, by February 2020, was having as many as a dozen drinks a day. His only chance of survival was a liver transplant, doctors said.
"So let's do that," his daughter Cameron Gorzney, now 22, told them. She was ready for anything that would save her dad, the man who had coached her softball team until high school and later cheered from the stands at every game.
But Gorzney wasn't eligible for a transplant, the doctors said. He hadn't been six months sober.
In the U.S., a widespread practice requires patients with alcoholic liver disease to complete a period of sobriety before they can get on the waiting list for a liver.
This informal policy, often called "the 6-month rule," can be traced to the 1980s. The thinking then — and among proponents of the practice today — was that six months of abstinence gave a patient's liver time to heal and, thus, avoid a transplant. If that didn't work, the patient would have proven they can stay sober and would not return to drinking after a transplant.
However, a landmark European study published in 2011 and several American studies in the decade since have exposed flaws in that premise. Six months of abstinence is not a good predictor of long-term sobriety, and for people with conditions like Gorzney's, more than half die within that time. Now, as the understanding of addiction evolves — viewing it as a disease rather than a personal failing — many surgeons and families say the six-month hold unfairly penalizes those with substance use disorder. And with alcoholic liver disease rising among young adults and pandemic-related drinking exacerbating those numbers, it has become a pressing concern.
"We have to move beyond denying people lifesaving therapy because we think they don't deserve it," said Dr. Andrew Cameron, head of the liver transplant program at Johns Hopkins Medicine in Baltimore. Doctors don't withhold treatment from people with diabetes who are obese or people with sexually transmitted infections who had unprotected sex, he said.
Cameron and his colleagues published a study this August, which found that among patients with alcoholic liver disease who were made to wait six months and those who were not, about 20% in each group returned to drinking one year after their transplants. That means about 80% stayed sober, regardless of how long they abstained from alcohol before the surgery.
"There was nothing at all helpful or predictive about a six-month waiting period," Cameron said.
No national regulation determines how long a patient needs to be abstinent before being added to the waitlist; each transplant center sets its own policies. As of 2019, only about one-third of liver transplant hospitals in the U.S. had performed a transplant without one. Patients who don't live near those hospitals — or don't have the knowledge and resources to get to them — can die without ever making it onto the waitlist, Cameron said.
On the other hand, some physicians worry abandoning the six-month rule could overwhelm the limited supply of donor organs. With nearly 12,000 people on the waiting list for a liver, it's crucial to ensure patients who receive transplants are ready to care for themselves and the "gift of the donated organ," said Dr. Kenneth Andreoni, a transplant surgeon and past president of the United Network for Organ Sharing, which manages the nation's transplant system. (UNOS determines who ultimately receives a donor organ, but it does not determine who can or cannot be put on the waitlist.)
Since 2016, alcoholic liver disease has been the most commonly identified justification for a liver transplant, and since these patients often have dire prognoses with little time to live, they can quickly jump to the top of the waiting list, surpassing those with liver cancer or other diseases. When one patient receives a liver, "someone else is not getting that organ," Andreoni said. "It's just math."
He said more long-term research is needed. "If all these people [who receive transplants without the waiting period] are doing great and living 15 years, then that's the right answer." Only time and statistics will tell.
Dr. Josh Levitsky, treasurer of the American Society of Transplantation, said some hospitals may worry that transplanting organs into patients with a higher risk of relapse could result in poor outcomes and threaten their accreditation or insurance contracts.
In fact, some insurance companies require patients to provide documentation of a sobriety period before agreeing to cover the cost of surgery. A study examining Medicaid policies in 2017 found 24 states had such policies, while 14 did not. (Twelve states didn't perform any liver transplants that year.)
In Brian Gorzney's case, insurance wasn't the issue. Finding a hospital to say yes was.
When the team at North Kansas City Hospital, which is not a transplant center, suggested Gorzney look into hospice options, his family refused. They took him across state lines to the University of Kansas Health System for a second opinion.
There, Gorzney's daughter Cameron, his ex-wife (Cameron's mom), his then-girlfriend and his sister teamed up to explain why they knew Gorzney would stay sober and care for a new liver responsibly. He had held steady jobs throughout his life, they said. He had never had a DUI. He coached his daughters' softball teams and was like a father figure to his sister, who is 10 years younger. He was headed to rehab before this crisis started, and he had a supportive family to help him sustain sobriety after surgery.
But, ultimately, the hospital's transplant committee said no.
In a statement about the general transplant process, Dr. Ryan Taylor, medical director of liver transplantation at the hospital, said each candidate is reviewed by a committee of more than 30 members. "High risk transplant patients may be required to complete 6 months of counseling to demonstrate an ongoing commitment to sobriety," he wrote, but there is an "expedited pathway" for people with alcoholic hepatitis who also have a "low risk for recidivism."
Gorzney was considered for this pathway, but the committee didn't approve him, his daughter Cameron said.
She was devastated by the no. But she's stubborn, she said, just like her dad. So, she and the rest of the family frantically scoured news articles and academic studies and called transplant hospitals across the country for another option.
"My dad was really deteriorating each day," she said.
They finally settled on the University of Iowa, where Cameron Gorzney had attended her first year of college and heard of its renowned medical system. The family made their case on Gorzney's behalf again. This time, they got a yes. The family's group text exploded, Cameron recalled.
Dr. Alan Gunderson, medical director of liver transplantation at the University of Iowa Hospitals and Clinics, said most hospitals that allow transplants without the six-month wait look at similar factors: the patient's medical need, financial stability, social support, understanding of their addiction and desire to recover. But the subjectivity of these measures means different transplant committees can come to different decisions.
In a letter to Gorzney, the Iowa transplant team explained they'd typically recommend a six-month waiting period but were approving him for the waiting list immediately because he wouldn't survive otherwise. In return, Gorzney agreed to attend counseling and treatment programs after the transplant.
Within 24 hours of being put on the waitlist, Gorzney received a new liver.
Today, more than a year and a half later, Gorzney, 52, is still sober and embracing the "opportunity to be somebody that I haven't been in a while," he said.
He and his girlfriend are engaged, and he's grateful to see his daughters, Cameron and Carson, grow into young adults. A lifelong Illinois Fighting Illini football fan, he even considers rooting for the Iowa Hawkeyes now.
But it worries him that the six-month rule, which led his family to travel to three hospitals in three states, still stymies others.
"People are, unfortunately, passing away … not knowing that there may be other options for them because they don't have a support group that I had that was aggressive enough and strong enough to reach out and not accept no on the first response they got."
As Congress debates cutting prescription drug costs, a poll released Tuesday found the vast majority of adults — regardless of their political party or age — support letting the federal government negotiate drug prices for Medicare beneficiaries and those in private health insurance plans.
The argument that pharmaceutical companies need to charge high prices to invest in research and develop new drugs does little to change that sentiment, according to the new KFF poll. Most respondents agreed the negotiation strategy is needed because Americans pay more than people in other countries and because companies' profits are too high.
Variouspolls, in addition to KFF's, have found the plan to allow Medicare to negotiate prescription drug prices to be very popular. (KHN is an editorially independent program of KFF.) The policy has polled favorably for at least the past six years, according to Ashley Kirzinger, associate director of public opinion and survey research at KFF.
Still, congressional lawmakers have yet to reach a consensus on whether to include such a provision in the major reconciliation bill aimed at funding President Joe Biden's domestic policy agenda and enhancing social programs. Republican lawmakers generally oppose efforts to impose price restraints on prescription drugs. Democrats in the House are pushing a bill that would allow changes in Medicare drug policies, including negotiations of prices for some medications. The bill passed the House last year but has run into opposition this fall. A few moderate Democrats have introduced a narrower approach.
The KFF poll found 83% of the public — including 91% of Democrats, 85% of Independents, 76% of Republicans and 84% of seniors — initially favored the federal government negotiating lower drug prices for both Medicare and private insurance. These opinions were relatively unchanged by the arguments in favor or against the policy, the poll found. Even Republican support remained relatively steady, at 71%, after hearing concerns about how negotiations could upend the pharmaceutical industry. However, the share of Republicans who "strongly" favored the plan dipped from 44% to 28%.
For example, large majorities regardless of party identification and age found the following argument convincing: "Those in favor say negotiation is needed because Americans pay higher prices than people in other countries, many can't afford their prescriptions, and drug company profits are too high."
A third, including a slight majority of Republicans 65 or older, found the following argument convincing: "Those opposed say it would have the government too involved and will lead to fewer new drugs being available in the future."
In addition, 93% — including 90% of Republicans — said that even if prescription prices were lower "drug companies would still make enough money to invest in the research needed to develop new drugs," while just 6% said "drug companies need to charge high prices in order to fund the innovative research necessary for developing new drugs."
These findings represent a change from a June KFF poll, which found attitudes changed after hearing assertions that allowing the federal government to negotiate Medicare prescription drug prices could lead to less research and development or limited access to newer prescriptions.
"This [latest] poll did a better job of representing what's happening in the debate," said Kirzinger. "The public is hearing both sides of the argument."
Pharmaceutical companies have spent a lot of money on messaging. PhRMA, the industry's trade group, launched a seven-figure ad campaign against legislation to lower drug prices through negotiation. Pharmaceutical companies have spent the most of any single industry on federal lobbying this year and donated sizable sums to House Democrats opposed to the plan, according to Open Secrets.
But the Medicare drug-pricing negotiation plan outlined in H.R. 3 (or the "Elijah E. Cummings Lower Drug Costs Now Act") is estimated to save roughly $500 billion in federal spending for Medicare drugs over 10 years, according to a Congressional Budget Office estimate. Many Democrats hope to use the savings to expand coverage in Medicare and Medicaid as they piece together their larger spending plan.
The KFF poll also found most people have little or no confidence that Biden or Congress will "recommend the right thing" for the country on prescription drug prices. The vast majority expressed the same about drug companies. A slight majority reported confidence in what AARP recommends — and the advocacy group backs the negotiated Medicare prices.
The KFF Health Tracking Poll was conducted from Sept. 23 to Oct. 4 among a nationally representative sample of 1,146 adults, including an oversample of adults 65 and older. The margin of sampling error is plus or minus 4 percentage points for the full sample.
Community clinics in California say they haven't been paid for at least 1 million COVID-19 vaccine doses given since January, creating a "massive cash flow problem" for some and complicating efforts to retain staff. Clinics in other states, including Michigan and Mississippi, are also awaiting payment.
The delays stem from the distinct way federally qualified health centers are reimbursed for care under Medicaid, the joint federal-state program providing health coverage for low-income people. Some centers are not even billing for the shots because they say it's too complicated.
Clinics are owed tens of millions of dollars, at minimum, for shots they've given since the vaccines received emergency authorization.
Of the roughly 70,000 doses administered by La Clínica de la Raza, an organization with more than 30 Bay Area locations, almost none of those costs have been reimbursed, chief financial officer Susan Moore said. And the clinics don't expect to receive reimbursement for around half of those shots because they were administered to the community without collecting insurance information. The extra staff time and supplies were covered with grant money.
"We were monitoring our cash very closely," Moore said. "Early in the pandemic I was very concerned, but by the time the vaccine came out, it was clear to me that we were going to have enough cash in the short term."
The Biden administration has relied on the clinics to boost vaccination rates among racial and ethnic minorities and people living in poverty. Health centers have administered nearly 15 million vaccine doses, federal data shows, although it is unclear how many of those were given during a patient visit.
Under federal law, the government pays health centers a set rate for patient visits, each potentially costing hundreds of dollars. Many state Medicaid agencies have said that if a patient receives a COVID shot along with other care, the clinic's cost to give the vaccine is covered as part of its normal payment rate.
Troubles getting paid occur when the COVID vaccination is the only service provided, officials say, such as during a mass immunization clinic.
During large-scale vaccine events, "we're usually administering vaccines without that broader service," said Phillip Bergquist, chief operating officer of the Michigan Primary Care Association, which lobbies for health centers.
Some states have told health centers they can bill Medicaid separately for each dose administered in that situation, such as at the Medicare payment level of approximately $40 per shot. But others, like Michigan and California, have endured a months-long process with the Centers for Medicare & Medicaid Services to devise a payment formula for how much it costs a clinic to give a shot.
CMS said it is reviewing proposals from 13 states to pay clinics for the vaccinations. "We are continuing to work with states on their proposals," a CMS spokesperson said. If they are approved, the clinics would be paid retroactively.
Michigan has been working with CMS to figure out reimbursement "when those vaccines are administered as a stand-alone service," said Bob Wheaton, spokesperson for the state's health department. Bergquist said the calculated cost in Michigan was just shy of $40 a dose.
California devised a plan that "meets federal requirements that reimbursement to these clinics be based on cost to provide services," said Carol Sloan, spokesperson for the California Department of Healthcare Services.
California's average cost to provide each dose is about $67, based on data clinics provided.
Because of the short shelf life of an open vial of vaccine, health centers opted for dedicated vaccination clinics instead of individual appointments, to avoid wasting doses, said Andie Martinez Patterson, a senior vice president at the California Primary Care Association, which lobbies for the state's health centers.
Lack of payment is "untenable given these providers' financial restraints and tremendous outlay of resources during this historic pandemic response," Barbara Ferrer, director of the Los Angeles County Department of Public Health, wrote in a Sept. 22 letter to CMS Administrator Chiquita Brooks-LaSure. In interviews, clinics cited high expenses related to vaccination, including running community-based clinics and targeted social media campaigns.
"There's a tremendous amount of misinformation and disinformation out there," said Jim Mangia, CEO of the St. John's Well Child & Family Center in Los Angeles, which opened 26 vaccination sites and operates three mobile units. "You kind of have to do double the work to counter it."
Angel Greer, CEO of Coastal Family Health Center on Mississippi's Gulf Coast, said not receiving payment to help cover the clinic's staffing costs is detrimental. More than 50% of the health center's patients are uninsured — and 14% each are on Medicare or Medicaid. The federal Health Resources and Services Administration separately reimburses clinics for vaccines administered to uninsured people.
In Mississippi, state officials initially proposed a plan that would have reimbursed health centers at the Medicare rate for stand-alone vaccinations. CMS has not approved it.
"I'm sure, across the nation is no different than Mississippi in our struggles to maintain adequate workforce. It's extremely difficult to be competitive with these workforce constraints when we're not being reimbursed for these services," Greer said. The health center administered 1,000 COVID vaccine doses in September, with the "overwhelming majority" occurring outside a regular medical visit, Greer said.
In winter 2020, it became clear California clinics were going to have to eat the costs of vaccination for a while, Martinez Patterson said. They were "hoping on a prayer that most of their costs would be reimbursed" but went ahead and vaccinated patients anyway.
Scott McFarland, CEO of MCHC Health Centers, said his staff at four clinics in rural Lake and Mendocino counties have administered 3,500 shots without reimbursement.
"I'm fairly confident that we will eventually get paid, but this is one of the downsides to being a community health center," McFarland said, a sentiment others expressed. The clinic is still giving shots, and he thinks the money will come eventually. "It's just a timing issue, I guess."
Health centers are pulling from different pots to stay afloat: The American Rescue Plan Act provided $7.6 billion to clinics to support COVID vaccination, testing and treatment. Clinics relied on small-business loans from the Paycheck Protection Program, as well as state money, for vaccination efforts. "I do think because of the federal relief, there is not a fire," Martinez Patterson said.
Health centers in other states echoed that.
"We do not have an issue with reimbursement," said Dr. Andrea Caracostis, CEO of the Hope Clinic in Houston. She noted that the federal government paid for vaccines and that some health centers' payment rates cover vaccines.
Fifty-one federally qualified health centers in California earlier this year reported unpaid claims for 1 million doses. The actual total is probably higher; California has 188 health centers.
"We don't view this small subset, nor the data provided, as sufficiently representative" to accurately estimate the extent of unpaid vaccination claims, Sloan said.
Health centers in California have administered 4.8 million doses, according to federal data.
"We're just whittling away at it," said Mangia, of St. John's.
St. John's anticipates getting reimbursed for doses under Medicaid in November or December, the clinic said through a spokesperson.
"We know they're good for it. We know it's coming," Louise McCarthy, CEO of the Community Clinic Association of Los Angeles County, said of the Medicaid payments. "But it's really hard to hire people when you don't have cash flow."
The San Leandro Hospital emergency department, where nurse Mawata Kamara works, went into lockdown recently when a visitor, agitated about being barred from seeing a patient due to COVID-19 restrictions, threatened to bring a gun to the California facility.
It wasn't the first time the department faced a gun threat during the pandemic. Earlier in the year, a psychiatric patient well known at the department became increasingly violent, spewing racial slurs, spitting toward staffers and lobbing punches before eventually threatening to shoot Kamara in the face.
"Violence has always been a problem," Kamara said. "This pandemic really just added a magnifying glass."
In the earliest days of the pandemic, nightly celebrations lauded the bravery of front-line healthcare workers. Eighteen months later, those same workers say they are experiencing an alarming rise in violence in their workplaces.
A nurse testified before a Georgia Senate study committee in September that she was attacked by a patient so severely last spring she landed in the ER of her own hospital.
At Research Medical Center in Kansas City, Missouri, security was called to the COVID unit, said nurse Jenn Caldwell, when a visitor aggressively yelled at the nursing staff about the condition of his wife, who was a patient.
In Missouri, a tripling of physical assaults against nurses prompted Cox Medical Center Branson to issue panic buttons that can be worn on employees' identification badges.
Hospital executives were already attuned to workplace violence before the pandemic struck. But stresses from COVID have exacerbated the problem, they say, prompting increased security, de-escalation training and pleas for civility. And while many hospitals work to address the issue on their own, nurses and other workers are pushing federal legislation to create enforceable standards nationwide.
Even so, Michelle Wallace, chief nursing officer at Grady Health System in Georgia, said the violence is likely even higher because many victims of patient assaults don't report them.
"We say, 'This is part of our job,'" said Wallace, who advocates for more reporting.
Caldwell said she had been a nurse for less than three months the first time she was assaulted at work — a patient spit at her. In the four years since, she estimated, she hasn't gone more than three months without being verbally or physically assaulted.
"I wouldn't say that it's expected, but it is accepted," Caldwell said. "We have a lot of people with mental health issues that come through our doors."
Jackie Gatz, vice president of safety and preparedness for the Missouri Hospital Association, said a lack of behavioral health resources can spur violence as patients seek treatment for mental health issues and substance use disorders in ERs. Life can also spill inside to the hospital, with violent episodes that began outside continuing inside or the presence of law enforcement officers escalating tensions.
A February 2021 report from National Nurses United — a union in which both Kamara and Caldwell are representatives — offers another possible factor: staffing levels that don't allow workers sufficient time to recognize and de-escalate possibly volatile situations.
COVID unit nurses also have shouldered extra responsibilities during the pandemic. Duties such as feeding patients, drawing blood and cleaning rooms would typically be conducted by other hospital staffers, but nurses have pitched in on those jobs to minimize the number of workers visiting the negative-pressure rooms where COVID patients are treated. While the workload has increased, the number of patients each nurse oversees is unchanged, leaving little time to hear the concerns of visitors scared for the well-being of their loved ones — like the man who aggressively yelled at the nurses in Caldwell's unit.
In September, 31% of hospital nurses surveyed by that union said they had faced workplace violence, up from 22% in March.
Dr. Bryce Gartland, hospital group president of Atlanta-based Emory Healthcare, said violence has escalated as the pandemic has worn on, particularly during the latest wave of infections, hospitalization and deaths.
"Front-line healthcare workers and first responders have been on the battlefield for 18 months," Garland said. "They're exhausted."
Like the increase in violence on airplanes, at sports arenas and school board meetings, the rising tensions inside hospitals could be a reflection of the mounting tensions outside them.
William Mahoney, president of Cox Medical Center Branson, said national political anger is acted out locally, especially when staffers ask people who come into the hospital to put on a mask.
Caldwell, the nurse in Kansas City, said the physical nature of COVID infections can contribute to an increase in violence. Patients in the COVID unit often have dangerously low oxygen levels.
"People have different political views — they're either CNN or Fox News — and they start yelling at you, screaming at you," Mahoney said.
"When that happens, they become confused and also extremely combative," Caldwell said.
Sarnese said the pandemic has given hospitals an opportunity to revisit their safety protocols. Limiting entry points to enable COVID screening, for example, allows hospitals to funnel visitors past security cameras.
Research Medical Center recently hired additional security officers and provided de-escalation training to supplement its video surveillance, spokesperson Christine Hamele said.
In Branson, Mahoney's hospital has bolstered its security staff, mounted cameras around the facility, brought in dogs ("people don't really want to swing at you when there's a German shepherd sitting there") and conducted de-escalation training — in addition to the panic buttons.
Some of those efforts pre-date the pandemic but the COVID crisis has added urgency in an industry already struggling to recruit employees and maintain adequate staffing levels. "The No. 1 question we started getting asked is, 'Are you going to keep me safe?'" Mahoney said.
While several states, including California, have rules to address violence in hospitals, National Nurses United is calling for the U.S. Senate to pass the Workplace Violence Prevention for Healthcare and Social Service Workers Act that would require hospitals to adopt plans to prevent violence.
"With any standard, at the end of the day you need that to be enforced," said the union's industrial hygienist, Rocelyn de Leon-Minch.
Nurses in states with laws on the books still face violence, but they have an enforceable standard they can point to when asking for that violence to be addressed. De Leon-Minch said the federal bill, which passed the House in April, aims to extend that protection to healthcare workers nationwide.
Destiny, the nurse who testified in Georgia using only her first name, is pressing charges against the patient who attacked her. The state Senate committee is now eyeing legislation for next year.
Kamara said the recent violence helped lead her hospital to provide de-escalation training, although she was dissatisfied with it. San Leandro Hospital spokesperson Victoria Balladares said the hospital had not experienced an increase in workplace violence during the pandemic.
For healthcare workers such as Kamara, all this antagonism toward them is a far cry from the early days of the pandemic when hospital workers were widely hailed as heroes.
"I don't want to be a hero," Kamara said. "I want to be a mom and a nurse. I want to be considered a person who chose a career that they love, and they deserve to go to work and do it in peace. And not feel like they're going to get harmed."
Duluth, Minnesota, is hiring a social worker to help people with addiction and mental health problems.
Pueblo, Colorado, started paying homeless residents to clean city streets.
Palm Beach Gardens, Florida — in Palm Beach County, home to 160 golf courses — is building a new golf course.
These are among the thousands of ways cities and counties have started spending the first tranche of COVID relief money from the American Rescue Plan Act passed by Congress in March.
That economic rescue package provides $130 billion to cities and counties — with few restrictions on how the money can be spent. For many, it was their first economic relief directly received from the federal government.
States received $195 billion from ARPA. They had gotten other stimulus funding in earlier relief packages, including the CARES Act last year.
The infusion of dollars to cities and counties is intended to aid residents and businesses hurt by the COVID-19 pandemic, invest in long-term projects or supplement budgets hit by a drop in tax revenue caused by shutdown restrictions and economic slowdowns.
Half the money was made available in May and the rest will be available next year. The localities have until 2026 to spend it.
The money cannot be used to reduce taxes, add to rainy day funds, pay for legal settlements or buttress pension funds.
Other than that, local governments can spend the money virtually as they will. Many cities, such as Buffalo, New York and Houston, are initially classifying large chunks of the allocation as "revenue replacement," meaning they will use the funds to make up for shortfalls over what would have been expected if the pandemic had not occurred. This gives them the most flexibility, according to a Brookings Institution report.
Many jurisdictions, including West Palm Beach, Florida, and Livonia, Minnesota, have allocated some ARPA money for employee bonuses.
Chautauqua County, New York, approved nearly $95,000 for handguns and bulletproof vests for its sheriff's office. The county, which averages 120 inches of snow a year, also approved $480,000 for two snowplows/dump trucks and $810,000 for a snowblower.
Dubois County, Indiana, is using $350,000 of its $8 million to add campsites and a bathroom and make other improvements to a county park.
ARPA — a $1.9 trillion package that in addition to the relief money for localities included funding for COVID testing, unemployment benefits, child tax credits and a host of other programs — was a top priority of President Joe Biden and congressional Democrats after they took control in Washington earlier this year. The law was passed without support from Republicans, who argued that earlier COVID relief funding had not been fully spent and its effects were still being realized.
The echoes of that argument are still reverberating on Capitol Hill as Republicans fight Democrats on their plans to expand spending for social programs such as Medicare and Medicaid and climate change.
In contrast to past federal fiscal relief efforts — including the CARES Act — ARPA provides support to thousands of cities and counties. Cities with more than 50,000 people get money based on population size, poverty rates and overcrowding. Smaller cities receive money based on population.
The CARES Act provided money to 160 of the country's largest 1,300 counties, but ARPA money goes to all 3,000-plus counties, said Eryn Hurley, deputy director of government affairs for the National Association of Counties. "This money is very vital," she said, noting how the pandemic and economic downturn cost counties billions in revenue. "Counties are working hard to invest these funds as fast as possible for their communities and residents," she said.
Alan Berube, a senior fellow at the Brookings Institution who is tracking the relief dollars, said this is the first new massive grant funding program to city and counties in nearly 50 years with such flexible spending requirements. Most local governments, he added, are still trying to figure out how to spend the cash.
"You have to use this money to address the impact of the pandemic or an underlying condition in the community exacerbated by the pandemic, Berube said.
Some cities, including Seattle and Austin, Texas, are using the money to build affordable housing and programs to deal with the rise in the homeless population.
Berube said the Treasury Department may question whether Palm Beach Gardens, a largely upscale city just north of West Palm Beach, can use $2 million of its $2.9 million ARPA money to help build a golf course.
"That is a very aggressive reading of the regulation," he said.
Palm Beach Gardens officials defend the spending as "an investment in our community." Candice Temple, a city spokesperson, noted the money will go to develop the 115-acre site, which will include a par-3 golf course, clubhouse and bike paths. The total cost of the project is $16.8 million, with the rest of the money coming from a bond financing. The city plans to hire seven people to work at the course.
Pueblo, Colorado, Mayor Nicholas Gradisar said his city was grateful for the money even though sales tax revenue rose 3% last year and is up 30% in 2021. He credits the increase to the federal stimulus checks residents received and used to shop and eat out.
"All in all, it could have been a lot worse," Gradisar said.
His city used some of its ARPA funding to give its employees a $500 incentive payment for getting vaccinated. The money helped improve the vaccination rate from 43% in early August to about 66% when the program ended Sept. 15.
"Obviously, we were pleased more people signed up, but we still have a ways to go," Gradisar said.
Pueblo will also use some of the ARPA funding to address homelessness and lack of child care, he said.
The city put $500,000 into a summer reading program that rewards children with $100 for completing their assignments and targeted $376,000 for mental health specialists to work with the police. It's also paying people at a homeless shelter to clean city streets. So far, Pueblo has committed $2.3 million of the $18 million in ARPA money it expects to receive.
Martin Brown, a program manager for the National League of Cities, said city officials have been contacting the organization to ask how they can use the money. "For the $65 billion in revenue, there's probably 65 billion ways to spend it," he said.
Five New York state and local government agencies agreed to fix COVID-19 vaccine websites to make them accessible for blind users following a Department of Justice investigation spurred by a KHN story.
New York State's Department of Health, the City of New York's Department of Health, New York City Health and Hospitals Corp., Nassau County and Suffolk County entered into written agreements with the U.S. Attorney's Office for the Eastern District of New York, saying they have corrected issues that prevent blind or visually impaired users from accessing forms or navigating vaccine websites. In the agreements announced Tuesday, they pledged to maintain accessibility on those sites.
KHN's February investigation detailed how COVID vaccination registration and information websites at the federal, state and local levels violated disability rights laws and hindered the ability of blind people to sign up for the potentially lifesaving vaccines.
The investigation was cited in a March letter sent to the Departments of Justice and Health and Human Services from several senators, including Sen. Maggie Hassan (D-N.H.), who also asked HHS and Centers for Disease Control and Prevention leadership about the issue in a congressional hearing. The Department of Justice issued a memo the next month highlighting that "civil rights protections and responsibilities still apply" for those with vision disabilities, and HHS did as well.
In response to the KHN investigation, the Department of Justice reached out to WebAIM, according to the group's associate director, Jared Smith. WebAIM, a nonprofit web accessibility organization, ran an analysis at KHN's request that found accessibility issues on nearly all 50 states' vaccine websites, which provide general vaccine information, lists of vaccine providers and registration forms. WebAIM then helped the U.S. attorney's office in its investigation, Smith said.
Clark Rachfal, director of advocacy for the American Council of the Blind, said the public agreements are vital as they put "other jurisdictions on notice that this is a violation of the civil rights of people with disabilities."
Sachin Dev Pavithran, executive director of the U.S. Access Board, an independent agency of the federal government that works to increase accessibility, said he knew the department had investigations in progress in other states.
Inaccessibility for government websites is unlawful under the Rehabilitation Act of 1973 and the 1990 Americans with Disabilities Act, said Albert Elia, a blind attorney who works with the San Francisco-based TRE Legal Practice on accessibility cases.
He hopes the pandemic has shown just how vital online accessibility can be as so many people shifted to ordering their groceries, clothes and even medicine online.
"The notion that it's fine if online things are inaccessible — I hope we're beyond that now," he said. "I hope the general public realizes that to cut people out of online access is effectively cutting them out of life."
The National Federation of the Blind settled this summer with Curative, a startup that has administered COVID vaccines and tests in cities across the country. Curative admitted no wrongdoing but agreed to make its website accessible within 30 days and pay NFB's attorney fees, plus donate $2,500.
One blind California resident, Byran Bashin, who was unable to use Curative to register for his vaccine appointment online, was featured in the KHN investigation. "We hear a lot of lip service about inclusion and respect for diversity," he said Thursday. "Respect for our diversity begins with intelligently designing these processes."
Andy Imparato, a member of the White House's COVID-19 Health Equity Task Force and executive director of Disability Rights California, said he expects a report on inequities from the task force to be given to President Joe Biden within the month. He said the report will likely call for an outside evaluation of access issues in the COVID response, including website accessibility.
"The story that published had an impact across the country," Imparato said. "It was very specific, it was very detailed, and it was hard to ignore. I think it was incredibly helpful."
The National Federation of the Blind is pushing for a legislative fix to codify online accessibility rights, but Rachfal said a fix can be done without Congress.
"What's needed is some leadership from the administration and the Department of Justice to promulgate regulations that they already have the authority to do," Rachfal said.
Many transplant programs have chosen to either bar patients who refuse to take the COVID vaccines from receiving transplants, or give them lower priority on waitlists.
This article was published on Friday, October 8, 2021 in Kaiser Health News.
A Colorado kidney transplant candidate who was bumped to inactive status for failing to get a COVID-19 vaccine has become the most public example of an argument roiling the nation's more than 250 organ transplant centers.
Across the country, growing numbers of transplant programs have chosen to either bar patients who refuse to take the widely available COVID vaccines from receiving transplants, or give them lower priority on crowded organ waitlists. Other programs, however, say they plan no such restrictions — for now.
At issue is whether transplant patients who refuse the shots are not only putting themselves at greater risk for serious illness and death from a COVID infection, but also squandering scarce organs that could benefit others. The argument echoes the demands that smokers quit cigarettes for six months before receiving lung transplants or that addicts refrain from alcohol and drugs before receiving new livers.
"It is a matter of active debate," said Dr. Deepali Kumar, an expert in transplant infectious diseases at the University of Toronto and president-elect of the American Society of Transplantation. "It's really an individual program decision. In many programs, it's in flux."
Leilani Lutali, 56, a late-stage kidney disease patient from Colorado Springs, Colorado, learned in a Sept. 28 letter from UCHealth in Denver that if she didn't begin a COVID vaccine series within 30 days, she would lose her spot on the transplant waiting list. Both she and her living donor, Jaimee Fougner, 45, of Peyton, Colorado, refused to get vaccinated, citing religious objections and uncertainty about the safety and effectiveness of the vaccines.
"I have too many questions that remain unanswered at this point. I feel like I'm being coerced into not being able to wait and see and that I have to take the shot if I want this lifesaving transplant," Lutali said.
She said she offered to be tested for COVID before the surgery or to sign a waiver absolving the hospital of legal risk for her refusal of the vaccine. "At what point do you no longer become a partner in your own care regardless of your own concerns?" she said.
Lutali now hopes to take her transplant quest to Texas, where several hospitals, including Houston Methodist and Baylor University Medical Center in Dallas, said they don't require COVID vaccinations to approve active candidates for the national waiting list.
The difference between policies in Denver and Dallas — and elsewhere — underscore a tense national divide. As of late April, fewer than 7% of transplant programs nationwide reported inactivating patients who were unvaccinated or partially vaccinated against COVID, according to research by Dr. Krista Lentine, a nephrologist at the Saint Louis University School of Medicine.
But that was just a snapshot in late spring, and like all COVID-related practices, it's "rapidly changing," Lentine said.
UCHealth in Denver began requiring COVID vaccinations for transplant patients in late August, citing the American Society of Transplantation's August recommendation that "all solid organ transplant recipients should be vaccinated against SARS-CoV-2."
Patients who undergo transplant surgery have their immune systems artificially suppressed during recovery, to keep their bodies from rejecting the new organ. That leaves unvaccinated transplant patients at "extreme risk" of severe illness if they are infected by COVID, with mortality rates estimated at 20% to 30%, depending on the study, Dan Weaver, a spokesperson for UCHealth said. For the same reason, transplant patients who receive COVID vaccines after surgery may fail to mount a strong immune response, research shows.
UW Medicine in Seattle began mandating COVID vaccines this summer, said Dr. Ajit Limaye, director of the solid organ transplant infectious diseases program. Patients were already required to meet other stringent criteria to be considered for transplantation, including receiving inoculations against several illnesses, such as hepatitis B and influenza.
"For anyone who does not have a medical contraindication, basically, we're requiring it," he said. "There's a very strong sense to make it a requirement, like all the other hoops, straight up."
By contrast, Northwestern Medicine in Chicago, where doctors performed the first double-lung transplant on a COVID patient in June 2020, is encouraging — but not requiring — vaccination against the pandemic disease.
"We don't decline care of transplant based on vaccine status," said Jenny Nowatzke, Northwestern's manager of national media relations. "The patient also doesn't get any lower scores."
The lack of consistent practice across programs sends a mixed message to the public, said Dr. Kapilkumar Patel, director of the lung transplant program at Tampa General Hospital in Florida, where COVID vaccines are not required.
"We mandate hepatitis and influenza vaccines, and nobody has an issue with that," he said. "And now we have this one vaccination that can save lives and make an impact on the post-transplant recovery phase. And we have this huge uproar from the public."
Nearly 107,000 candidates are waiting for organs in the U.S.; dozens die each day still waiting. Transplant centers evaluate which patients are allowed to be placed on the national list, taking into account medical criteria and other factors like financial means and social support to ensure that donor organs won't fail.
"We really make all kinds of selective value judgments," said Dr. David Weill, former director of Stanford University Medical Center's lung and heart-lung transplant program who now works as a consultant. "When we're selecting in the committee room, I hear the most subjective, value-based judgments about people's lives. This is just another thing."
The centers can choose to place candidates on inactive status for a variety of reasons, including medical noncompliance, according to data from the United Network for Organ Sharing, which oversees transplants. As of Sept. 30, that category accounted for 738 of more than 47,000 registrants waiting in inactive status, though it's not clear how many are tied to vaccination status.
A particularly thorny question involves unvaccinated people who need transplants specifically because COVID infections destroyed their organs. As of late September, more than 200 lungs, as well as at least six hearts and two heart-lung combinations, had been transplanted for COVID-related reasons in the U.S., according to UNOS data.
Many of those organs were transplanted earlier in the pandemic, before any COVID vaccine was widely available. That's no longer the case, Weill said. "If you're just now getting vaccinated, you've done it at gunpoint, actually," he said. "It's not just a personal choice; they're making some kind of a statement."
Such patients are usually younger and healthier than other transplant candidates, aside from the COVID-related damage, and they're often acutely ill enough to go to the top of any transplant list. "The sick COVID patient might go ahead of the stable cystic fibrosis patient," Weill said.
Tampa General's Patel said he performed a lung transplant on a patient who was transferred to Florida after being delisted at another center because he wasn't vaccinated for COVID. "I mandated with him basically on a handshake that he will get his vaccine post-transplant," Patel said. "But his family? They haven't agreed."
Eventually, Patel said, he thinks nearly all transplant programs will mandate COVID vaccination, largely because transplant centers are evaluated on the longer-term survival of their patients.
"I think it's going to spread like wildfire across the country," he said. "If you start losing patients in a year due to COVID, it will be mandated sooner rather than later.
Dr. Aaron Kheriaty, a University of California-Irvine psychiatry professor, felt he didn't need to be vaccinated against COVID because he'd fallen ill with the disease in July 2020.
So, in August, he sued to stop the university system's vaccination mandate, saying "natural" immunity had given him and millions of others better protection than any vaccine could.
A judge on Sept. 28 dismissed Kheriaty's request for an injunction against the university over its mandate, which took effect Sept. 3. While Kheriaty intends to pursue the case further, legal experts doubt that his and similar lawsuits filed around the country will ultimately succeed.
That said, evidence is growing that contracting SARS-CoV-2, the virus that causes COVID-19, is generally as effective as vaccination at stimulating your immune system to prevent the disease. Yet federal officials have been reluctant to recognize any equivalency, citing the wide variation in COVID patients' immune response to infection.
Like many disputes during the COVID pandemic, the uncertain value of a prior infection has prompted legal challenges, marketing offers and political grandstanding, even as scientists quietly work in the background to sort out the facts.
For decades, doctors have used blood tests to determine whether people are protected against infectious diseases. Pregnant mothers are tested for antibodies to rubella to help ensure their fetuses won't be infected with the rubella virus, which causes devastating birth defects. Hospital workers are screened for measles and chickenpox antibodies to prevent the spread of those diseases. But immunity to COVID seems trickier to discern than those diseases.
The Food and Drug Administration has authorized the use of COVID antibody tests, which can cost about $70, to detect a past infection. Some tests can distinguish whether the antibodies came from an infection or a vaccine. But neither the FDA nor the Centers for Disease Control and Prevention recommend using the tests to assess whether you're, in fact, immune to COVID. For that, the tests are essentially useless because there's no agreement on the amount or types of antibodies that would signal protection from the disease.
"We don't yet have full understanding of what the presence of antibodies tells us about immunity," said Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories.
By the same token, experts disagree on how much protection an infection delivers.
In the absence of certainty and as vaccination mandates are levied across the country, lawsuits seek to press the issue. Individuals who claim that vaccination mandates violate their civil liberties argue that infection-acquired immunity protects them. In Los Angeles, six police officers have sued the city, claiming they have natural immunity. In August, law professor Todd Zywicki alleged that George Mason University's vaccine mandate violated his constitutional rights given he has natural immunity. He cited a number of antibody tests and an immunologist's medical opinion that it was "medically unnecessary" for him to be vaccinated. Zywicki dropped the lawsuit after the university granted him a medical exemption, which it claims was unrelated to the suit.
Republican legislators have joined the crusade. The GOP Doctors Caucus, which consists of Republican physicians in Congress, has urged people leery of vaccination to instead seek an antibody test, contradicting CDC and FDA recommendations. In Kentucky, the state Senate passed a resolution granting equal immunity status to those who show proof of vaccination or a positive antibody test.
Hospitals were among the first institutions to impose vaccine mandates on their front-line workers because of the danger of them spreading the disease to vulnerable patients. Few have offered exemptions from vaccination to those previously infected. But there are exceptions.
Two Pennsylvania hospital systems allow clinical staff members to defer vaccination for a year after testing positive for COVID. Another, in Michigan, allows employees to opt out of vaccination if they present evidence of previous infection and a positive antibody test in the previous three months. In these cases, the systems indicated they were keen to avoid staffing shortages that could result from the departure of vaccine-shunning nurses.
For Kheriaty, the question is simple. "The research on natural immunity is quite definitive now," he told KHN. "It's better than immunity conferred by vaccines." But such categorical statements are clearly not shared by most in the scientific community.
Dr. Arthur Reingold, an epidemiologist at UC-Berkeley, and Shane Crotty, a virologist at the respected La Jolla Institute for Immunology in San Diego, gave expert witness testimony in Kheriaty's lawsuit, saying the extent of immunity from reinfection, especially against newer variants of COVID, is unknown. They noted that vaccination gives a huge immunity boost to people who've been ill previously.
Yet not all of those pushing for recognition of past infection are vaccine critics or torchbearers of the anti-vaccine movement.
Dr. Jeffrey Klausner, clinical professor of population and public health sciences at the University of Southern California, co-authored an analysis published last week that showed infection generally protects for 10 months or more. "From the public health perspective, denying jobs and access and travel to people who have recovered from infection doesn't make sense," he said.
In his testimony against Kheriaty's case for "natural" immunity to COVID, Crotty cited studies of the massive COVID outbreak that swept through Manaus, Brazil, early this year that involved the gamma variant of the virus. One of the studies estimated, based on tests of blood donations, that three-quarters of the city's population had already been infected before gamma's arrival. That suggested that previous infection might not protect against new variants. But Klausner and others suspect the rate of prior infection presented in the study was a gross overestimate.
A large August study from Israel, which showed better protection from infection than from vaccination, may help turn the tide toward acceptance of prior infection, Klausner said. "Everyone is just waiting for Fauci to say, 'Prior infection provides protection,'" he said.
When Dr. Anthony Fauci, the top federal expert on infectious diseases, was asked during a CNN interview last month whether infected people were as well protected as those who've been vaccinated, he hedged. "There could be an argument" that they are, he said. Fauci did not immediately respond to a KHN request for further comment.
CDC spokesperson Kristen Nordlund said in an email that "current evidence" shows wide variation in antibody responses after COVID infection. "We hope to have some additional information on the protectiveness of vaccine immunity compared to natural immunity in the coming weeks."
A "monumental effort" is underway to determine what level of antibodies is protective, said Dr. Robert Seder, chief of the cellular immunology section at the National Institute of Allergy and Infectious Diseases. Recent studies have taken a stab at a number.
Antibody tests will never provide a yes-or-no answer on COVID protection, said Dr. George Siber, a vaccine industry consultant and co-author of one of the papers. "But there are people who are not going to be immunized. Trying to predict who is at low risk is a worthy undertaking."