The Biden administration and Congress are embroiled in high-stakes haggling over what urgent priorities will make it into the ever-shrinking social spending bill. But for the pharmaceutical industry there is one agenda: Heading off Medicare drug price negotiation, which it considers an existential threat to its business model.
The siren call to contain rising drug costs helped catapult Democrats to power, and the idea is popular among voters regardless of their politics. Yet granting Medicare broad authority to intervene in setting prices has nonetheless divided the party.
And so, as it normally does, the drug industry gave generously to members of Congress, according to new data from KHN's Pharma Cash to Congress database. Contributions covering the first half of this year show that some of its biggest donations were delivered with surgical-strike precision to sympathetic or moderate Democratic lawmakers the industry needs to remain in its corner.
Campaign donations to members of Congress — which must be reported to the Federal Election Commission — are the tip of the iceberg, signaling far greater activity in influence peddling that includes spending millions on lobbying activities and advertising campaigns.
Unusually, in the first half of this year Republicans and Democrats in Congress were virtually neck and neck in pulling in drug industry money, according to a KHN analysis of campaign contributions. In prior years, Republicans dominated giving from that sector, often by huge margins.
Pharmaceutical companies and their lobbying groups gave roughly $1.6 million to lawmakers during the first six months of 2021, with Republicans accepting $785,000 and Democrats $776,200, the Pharma Cash to Congress database shows. Since the 2008 cycle, the industry has generally favored Republicans. The exception was 2009-10, the last time Democrats controlled both chambers of Congress and the White House.
Democrats again narrowly hold both the House and Senate, and political scientists and other money-in-politics experts said the contributions likely reflect who is in power, which lawmakers face tougher reelection bids next year, and who has outsize sway over legislation affecting the industry's bottom line.
Several pharmaceutical companies paused contributions to Republican lawmakers who voted against certifying the results of the 2020 election, blunting the GOP's total fundraising haul and overall industry giving compared with other years.
The drug industry's campaign contributions are markedly strategic, said Steven Billet, an associate professor at the Graduate School of Political Management at George Washington University.
"This is a really well-organized commercial sector," Billet said. "If I'm one of these PACs, I've surveyed the landscape at the front end of the process, decided on our agenda and budget, and figured out who I may be able to get to and who I wouldn't be able to get to."
Of the top 10 recipients of funding, Republican lawmakers accounted for six; Democrats, four. Rep. Scott Peters (D-Calif.) received the most money of any member of Congress, with $63,900 in contributions in the first half of the year. Peters, whose San Diego-area district includes multiple drug companies, has consistently accepted money from drugmakers since he took office in 2013, according to KHN's database. Right behind Peters was Rep. Cathy McMorris Rodgers (R-Wash.), who received $50,000 from the industry in the first six months of 2021. McMorris Rodgers was chosen this year to be the most senior Republican on the House Energy and Commerce Committee, which has significant influence on pharmaceutical issues. Peters sits on the same committee.
"They're typically going to saturate the committees that are relevant to their industry," said Nick Penniman, CEO of Issue One, a nonprofit that advocates reforming money's influence in politics.
Next in line was Sen. Robert Menendez (D-N.J.), who accepted $49,300, the most of any senator this year despite not facing reelection until 2024. The vote of Menendez, a longtime ally of the industry, would be crucial for Democrats to pass any proposal giving the government greater control over drug prices. The pharmaceutical industry is a major employer in New Jersey, home to headquarters of behemoths like Johnson & Johnson, Merck, Novo Nordisk and Sanofi.
Menendez said he's waiting to see the proposal, "which I expect will include language to allow Medicare to negotiate drug prices."
"The focus of any proposal must be lowering patient costs," he said, "and that will drive my analysis."
Among other moderate Democrats is Sen. Kyrsten Sinema (D-Ariz.), whose vote also is critical to passage. She received $108,500 in pharma contributions in 2019-20, according to the KHN database. However, in the first half of this year, she received only $8,000. She has not said publicly where she stands on the current pricing proposal.
As Billet sees it, the pharmaceutical industry knew allowing Medicare to negotiate drug prices would likely be on the table, and drug companies shored up members, such as Peters and Menendez, who have sided with them in the past. Plus, "right now, the Democrats are driving the train, and because of that they're going to get a few more contributions," Billet added.
Peters received funds from nearly two dozen companies or industry groups, including Eli Lilly, Takeda Pharmaceutical, Pfizer, Merck, GlaxoSmithKline, EMD Serono and Amgen. Menendez's donors included Boehringer Ingelheim, Sanofi, Pfizer, Merck, Gilead Sciences, Eli Lilly, Teva and Novo Nordisk. A spokesperson for Peters did not respond to request for comment.
Controlling drug prices has broad support among adults regardless of political party, according to polling from KFF (KHN is an editorially independent program of KFF). But facing industry opposition, Democrats have yet to agree on a plan as lawmakers weigh which policies make it into a massive domestic spending bill to expand the social safety net and address climate change. Central to the industry's argument is that greater government intervention in setting prices would harm new drug development; however, drug pricing experts generally say this argument is overblown. Republicans remain unanimously opposed, which means Senate Democrats can't afford any defections to advance legislation.
Fourth in industry contributions was Sen. Catherine Cortez Masto (D-Nev.), a freshman lawmaker on the powerful Senate Finance Committee, which oversees legislation pertaining to federal health programs like Medicare. Cortez Masto received $46,000, with cash flowing in from companies like Eli Lilly, Merck, Pfizer, Johnson & Johnson and Mallinckrodt Pharmaceuticals, the latter of which filed for bankruptcy in 2020 after being swamped with litigation over its alleged role in the opioid crisis. One of her recent aides, Eben DuRoss, was hired as a lobbyist this year by the Pharmaceutical Research and Manufacturers of America, or PhRMA, federal disclosures show.
Cortez Masto is up for reelection next year in a battleground state that's been competitive between Republicans and Democrats in recent elections. She was narrowly elected in 2016, and recent polling showed she held a small lead against her expected Republican challenger in 2022, former Nevada attorney general Adam Laxalt.
But her contributions dwarf those of other Senate Democrats in close races. For example, in the first half of this year, Sen. Maggie Hassan (D-N.H.), who also sits on the Senate Finance Committee, reported having accepted $6,000.
Two other lawmakers in competitive seats, Sen. Raphael Warnock (D-Ga.) and Sen. Mark Kelly (D-Ariz.), didn't receive funding from the pharmaceutical sector.
Sarah Bryner, research director of OpenSecrets, a nonprofit that tracks money in politics, noted several reasons Cortez Masto would pull in more money. In addition to her committee seat and competitive race, politically she's more moderate than progressive lawmakers who have been bigger agitators against the drug industry.
"She's not seen as an extremist, which is the kind of person who would typically take in more money" from political action committees, Bryner said.
Cortez Masto was also a recent past chair of the Democratic Senatorial Campaign Committee and therefore heavily involved in the party's national fundraising efforts to preserve Democrats' Senate majority. Those relationships with corporate and other donors could be leveraged for her own race, Bryner said. "Once you've made all the relationships, it's not like they just disappear," she said.
Still, the freshman Democrat has openly supported allowing Medicare to negotiate prescription drug prices, in contrast to Menendez, who voted against the idea in 2019. The Nevada senator recently told KHN that she "absolutely" backs the policy and that the pharma cash flowing into her campaign coffers doesn't influence her decisions.
"I've already supported it in Finance and actually voted to pass legislation to do just that," Cortez Masto said. "We need to reduce the healthcare costs for so many in this country, and that's what I'm focused on doing, including reducing prescription drug costs."
Peters — who unseated a Republican in 2012 — was one of four moderate House Democrats who in September voted against a plan to give Medicare broad authority to negotiate prescription drug prices. They backed a narrower alternative that includes caps on out-of-pocket spending and limits the scope of Medicare's negotiating authority to a smaller set of medications.
The money Peters and McMorris Rodgers got from drugmakers ($63,900 and $50,000, respectively) significantly jumped from the same periods in past cycles. In the first half of 2019, Peters received $19,500, and during those same quarters in 2017 he got $36,000. McMorris Rodgers' haul for the first six months of 2019 was $2,500, and two years earlier it was $3,000. However, Menendez received more funding in the first half of 2019 ($52,000) than this year.
That some drugmakers — including Pfizer, Johnson & Johnson, Gilead and Eli Lilly — as well as PhRMA and the Biotechnology Innovation Organization, another lobbying group for the industry, paused contributions to Republicans after the events of Jan. 6 seems at least in part to account for overall pharma contributions dropping in comparison with other years. In the first half of 2019 drugmakers gave $3.7 million, and in the first half of 2017 they gave about $4.4 million, versus 2021's $1.6 million.
However, other drug company PACs and their industry groups kept up contributions or failed to void checks they'd issued to those who refused to certify the election results, according to a KHN analysis of the FEC data.
They include Merck, Novo Nordisk, GlaxoSmithKline, AstraZeneca, Genentech, Boehringer Ingelheim, Amgen, Teva, EMD Serono and the Association for Accessible Medicines, which all gave $1,000 or more to at least one of the 147 Republicans who voted to overturn the election results.
Direct contributions to lawmakers' political accounts are only one way for the industry to channel cash to Congress. Companies also give money to trade associations and 501(C)(4)s, which are nonprofits that often function as "dark money" groups because they are not required to disclose their donors.
"We know that they're giving; they didn't stop giving. Their giving went underground," said Carlos Holguin, research director for the Center for Political Accountability, a nonprofit that tracks money in politics.
Groups also funnel money into advertising — in September, PhRMA announced a seven-figure ad campaign opposing Democrats' drug pricing plan — or into advocacy groups from which it may eventually trickle down to political candidates.
Another factor? Hail Mary COVID-19 vaccines, developed and distributed in record time, that may have shored up goodwill with lawmakers. Or that, despite everything lawmakers have said about lowering drug costs, the industry suspects drug pricing legislation will stall once again and don't want to spend their political capital on the issue.
"I think, frankly, drugmakers know they've won the match when it comes to drug pricing. This whole question of the cost of pharmaceuticals, it has come up for literally decades now and they have successfully shut it down, year after year," Penniman said. "At a certain point, they know they have driven the nail far enough in the wood and they don't need to do much more."
For the past 18 months, while I was undergoing intensive physical therapy and many neurological tests after a complicated head injury, my friends would point to a silver lining: "Now you'll be able to write about your own bills." After all, I'd spent the past decade as a journalist covering the often-bankrupting cost of U.S. medical care.
But my bills were, in fact, mostly totally reasonable.
That's largely because I live in Washington, D.C., and received the majority of my care in next-door Maryland, the one state in the nation that controls what hospitals can charge for services and has a cap on spending growth.
Players in the healthcare world — from hospitals to pharmaceutical manufacturers to doctors' groups — act as if the sky would fall if healthcare prices were regulated or spending capped. Instead, healthcare prices are determined by a dysfunctional market in which providers charge whatever they want and insurers or middlemen like pharmacy benefit managers negotiate them down to slightly less stratospheric levels.
But for decades, an independent state commission of healthcare experts in Maryland, appointed by the governor, has effectively told hospitals what each of them may charge, with a bit of leeway, requiring every insurer to reimburse a hospital at the same rate for a medical intervention in a system called "all-payer rate setting." In 2014, Maryland also instituted a global cap and budget for each hospital in the state. Rather than being paid per test and procedure, hospitals would get a set amount of money for the entire year for patient care. The per capita hospital cost could rise only a small amount annually, forcing price increases to be circumspect.
If the care in the Baltimore-based Johns Hopkins Medicine system ensured my recovery, Maryland's financial guardrails for hospitals effectively protected my wallet.
During my months of treatment, I got a second opinion at a similarly prestigious hospital in New York, giving me the opportunity to see how medical centers without such financial constraints bill for similar kinds of services.
Visits at Johns Hopkins with a top neurologist were billed at $350 to $400, which was reasonable, and arguably a bargain. In New York, the same type of appointment was $1,775. My first spinal tap, at Johns Hopkins, was done in an exam room by a neurology fellow and billed as an office visit. The second hospital had spinal taps done in a procedure suite under ultrasound guidance by neuroradiologists. It was billed as "surgery," for a price of $6,244.38. The physician charge was $3,782.
I got terrific care at both hospitals, and the doctors who provided my care did not set these prices. All the charges were reduced after insurance negotiations, and I generally owed very little. But since the price charged is often the starting point, hospitals that charge a lot get a lot, adding to America's sky-high healthcare costs and our rising insurance premiums to cover them.
It wasn't easy for Maryland to enact its unique healthcare system. The state-imposed rate setting in the mid-1970s because hospital charges per patient were rising fast, and the system was in financial trouble. Hospitals supported the deal — which required a federal waiver to experiment with the new system — because even though the hospitals could no longer bill high rates for patients with commercial insurance, the state guaranteed they would get a reasonable, consistent rate for all their services, regardless of insurer.
The rate was more generous than Medicare's usual payment, which (in theory at least) is calculated to allow hospitals to deliver high-quality care. The hospitals also got funds for teaching doctors in training and taking care of the uninsured — services that could previously go uncompensated.
In subsequent decades, however, hospitals did end runs around price controls by simply ordering more hospital visits and tests. Spending was growing. Maryland risked losing the federal waiver that had long underpinned its system. Also, under the waiver's terms, Maryland's hospitals were at risk for paying a hefty penalty to the federal government for the excessive growth in cost per patient.
That's why in 2014 the state worked with the federal Centers for Medicare & Medicaid Services to institute the global cap and budget system in place today. Dr. Joshua Sharfstein, who was the state's health and mental hygiene secretary, met skeptical hospital administrators to "sell the concept," as he described it, assuring them the hospitals would still get reasonable revenue while gaining new opportunities to improve the health of their communities with money to invest in preventive services.
Studies show the program, which was further revised in 2019, generally worked at keeping costs down and generated savings of $365 million for Medicare in 2019 and over $1 billion in the prior four years. What's more, working with a fixed budget has provided incentives for hospitals to keep patients out, resulting in programs like better outpatient efforts to manage chronic illnesses and putting doctors in senior housing to keep residents out of hospitals through on-site care.
Instituting this type of plan may be politically unacceptable statewide in other places today, given the much greater power now of hospital trade groups and large consolidated hospital networks. "Where hospitals are making money hand over fist, it's a hard sell to switch," Sharfstein said. "But where hospitals are facing economic pressure, there is much more openness to financial stability and the opportunity to promote community health."
Sharfstein thinks the Maryland approach can be especially attractive for financially strapped rural and urban hospitals that treat mostly people on Medicaid and the uninsured.
Though Maryland is an oddity in the United States (the few other states that tried price controls in the 1970s abandoned the experimentlong ago), many countries successfully use price guidelines and budget limits to control medical spending. Notable among them is Germany, whose health system is otherwise similar to the United States', with multiple insurers. A landmark 1994study comparing efforts here and abroad did find that the German system, for example, can be stingier at providing care that is expensive or elective.
But, referring in part to that issue, the study's author concluded that costs are so high in the United States that the country "could probably lower our expenditures and see none of the problems that we found in our study for a number of years."
Data also shows that operating margins, a measure of profit, are generally slimmer in Maryland than those of big health systems in the rest of the country. Johns Hopkins' margin was 1.2% in fiscal year 2019, compared with 6.9% at the Mayo Clinic in Minnesota and 5.8% at the University of Pennsylvania Health System; Stanford Healthcare's was 7.1%.
But those margins can also reflect how much of its income a hospital chooses to spend on things like amenities and executive pay. Living with financial constraints may be at least partly why Johns Hopkins Hospital's main entrance is pleasant but functional, lacking the elegant art-filled marble lobbies I often encounter at its peer hospitals.
My experience demonstrates that excellent care can be delivered to patients by a system that works within financial limits. And that's something America needs.
Many patients dealing with mental health crises are having to wait several days in an ER until a bed becomes available at one of Georgia's five state psychiatric hospitals, as public facilities nationwide feel the pinch of the pandemic.
"We're in crisis mode,'' said Dr. John Sy, an emergency medicine physician in Savannah. "Two weeks ago, we were probably holding eight to 10 patients. Some of them had been there for days."
The shortage of beds in Georgia's state psychiatric facilities reflects a national trend linked to staffing deficits that are cramping services in the public mental health system. The bed capacity problem, which has existed for years, has worsened during the COVID-19 pandemic, creating backlogs of poor or uninsured patients as well as people in jails who are awaiting placement in state facilities.
Many state workers, such as nurses, are leaving those psychiatric units for much higher pay — with temp agencies or other employers — and less stressful conditions. The departures have limited the capacity of state-run psychiatric units for patients, who often are poor or uninsured, forcing some people with serious mental illness to languish in hospital emergency rooms or jails until beds open up in the state systems, according to local leaders of the National Alliance on Mental Illness.
Nationally, the shortage of beds and mental health workers has collided with an increasing, pandemic-driven demand for mental health treatment.
"ERs have been flooded with patients needing psychiatric care," said Dr. Robert Trestman, chairperson of the American Psychiatric Association's Council on Healthcare Systems and Financing. "The current crisis is unprecedented in the extent, severity and sweep of its national impact."
Virginia has severely curtailed admissions to state mental hospitals because of staffing shortages amid increased demand for services. "I have never seen an entire system bottleneck this bad," said Kathy Harkey, executive director of the National Alliance on Mental Illness' Virginia chapter. The strain is spilling over into the private system, she added.
A Texas advisory committee reported in July that a near-record number of people were on the waitlist for state hospital beds for forensic patients, meaning those involved in the court system who have mental illness.
Last month, National Guard soldiers returned to Oregon's largest public psychiatric facility to shore up the workforce there.
In Maine, a committee of criminal justice and mental health officials has been working on adding state psychiatric beds and finding placements for people who need treatment for mental illness but are being held in jails.
The well-insured normally can choose private facilities or general hospital psychiatric wards, Trestman said. But in many cases, those beds are now filled, too.
Like the medical system overall, the behavioral health system is "under a great deal of strain," said Dr. Brian Hepburn, head of the National Association of State Mental Health Program Directors. The workforce shortage is especially acute at inpatient or residential behavioral health facilities, he said, and that pressure extends to private providers.
States are now focused on suicide prevention and crisis services to reduce pressure on emergency rooms and inpatient services, Hepburn added.
In Georgia, roughly 100 beds in the state's five psychiatric hospitals — or about 10% — are empty because there's no one to take care of the patients who would occupy them. Space in short-term crisis units is also squeezed. The turnover rate for hospital workers was 38% over the past fiscal year, according to the state Department of Behavioral Health and Developmental Disabilities.
Beyond hospitals, Melanie Dallas, CEO of Highland Rivers Health, which delivers behavioral health services in northern Georgia, said the challenge of dealing with higher demand amid such a diminished number of staffers is unprecedented in her 33 years in the field. "Everybody is exhausted."
Nationally, scores of nurses and other mental health workers have left state jobs.
A state hospital nurse in the U.S. typically makes $40 to $48 an hour, while the rate for a temp agency nurse runs $120 to $200, Trestman said.
"A lot of people are chasing the COVID money," said Netha Carter, a nurse practitioner who works in an Augusta, Georgia, state facility for developmentally disabled people. She said that temp agencies are offering "triple the pay" given by state facilities, though she's staying put because she likes the kind of work she's doing.
Kim Jones, executive director of NAMI in Georgia, said she has received more calls about people with mental health needs who can't get long-term hospital services as the bed backlog increases.
Such waits for care can worsen patients' conditions. Several years ago, Tommie Thompson's son Cameron waited 11 months to get a state hospital bed in Atlanta while in jail. "By the time he got to the hospital, he was totally psychotic," Thompson said.
The backlog in public services is playing out in jails across Georgia, with more people being kept behind bars because mental health facilities are swamped.
The Georgia Sheriffs' Association said its members have relayed their difficulties in placing people in state-run treatment. "A lot of these folks don't need to be in jail, but they're stuck in there," said Bill Hallsworth, the association's coordinator of jail and court services. "There's no place to put them."
Hospital ERs also are feeling the shortage of state beds, said Anna Adams, a senior vice president of the Georgia Hospital Association. People with mental illness arriving in the ER "tend to be at the end of the line," said Robin Rau, CEO of Miller County Hospital in rural southwestern Georgia.
Rau said the bed backlog is horrible. "COVID has just exacerbated everything."
Need Help?
If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-8255 or text HOME to the Crisis Text Line at 741741.
St. Luke's, a clinic with a staff of four in a nondescript shopping center, offers an unorthodox combination of concierge-style medicine for the well-off and charity care for the uninsured.
This article was published on Tuesday, October 26, 2021 in Kaiser Health News.
MODESTO, Calif. — Britta Foster and Minerva Tiznado are in different leagues as far as healthcare is concerned.
Foster, who married into the family that owns the $2.5 billion Foster Farms chicken company, has Blue Shield coverage as well as a high-octane primary care plan that gives her 24/7 digital access to her doctor for a $5,900 annual fee that also covers her husband and two of their children.
Tiznado is from Nayarit, Mexico, and has no insurance. She gets free primary care visits and steep discounts on prescription drugs, lab tests and imaging.
But Tiznado, 32, and Foster, 48, go to the same place for their care: St. Luke's Family Practice, in this Central Valley city of about 217,000. St. Luke's, a clinic with a staff of four in a nondescript shopping center, offers an unorthodox combination of concierge-style medicine for the well-off and charity care for the uninsured.
The annual fees that St. Luke's collects from Foster's family and some 550 other paying patients help cover free care for a somewhat larger number of uninsured patients, many of them, like Tiznado, Spanish-speaking immigrants who can't get Medicaid because they lack documents.
The clinic does not accept insurance of any kind but requires its paying patients to have coverage for major medical expenses outside its scope of care.
The paying patients, whom St. Luke's calls "benefactors," say they are happy to participate in this "Robin Hood" model. It gives them highly personalized care with great access to their doctors and the emotional satisfaction of supporting those less privileged, the "recipients."
Foster said it's been a "huge, huge benefit" for her family to be able to text or call their doctor at any time and be seen on short notice: "Knowing that their group is here also to serve our community makes it all feel even more important."
Tiznado, who visited the clinic one September morning for a scheduled monitoring of ovarian cysts, said St Luke's "has helped us a lot — economically and in every way. I think if we moved somewhere else, I would continue coming here."
But Tiznado and the other uninsured patients don't get the same 24/7 access that benefactors do. The two groups used separate waiting rooms until the pandemic hit.
St. Luke's is a local response to systemic U.S. healthcare problems including physician burnout, patient dissatisfaction and the fact that millions still lack care. Nearly 3.2 million Californians, including 1.3 million undocumented people, will be uninsured in 2022, although the state is gradually expanding Medicaid coverage to many immigrants. St. Luke's is part of the movement for direct primary care, an alternative for doctors fleeing insurance-dominated medical groups.
Roughly 200 direct primary care practices start up each year in the United States, and there are currently 1,581 of them employing an estimated 3,000 doctors, according to Dr. Philip Eskew, founder of DPC Frontier, which provides resources for doctors who want to make the switch. That's a tiny fraction of the nearly 209,000 primary care doctors in the U.S.
"We are indeed a small movement at this time," Eskew said.
Their biggest challenges are regulatory. If the clinics take fees from people enrolled in Medicare, for example, their doctors must forgo Medicare reimbursement anywhere they practice. And some state regulators may consider direct primary care practices to be health plans and impose terms or restrictions that make it difficult or impossible for them to operate.
Doctors in direct primary care typically charge patients a monthly or annual fee in exchange for enhanced access via phone, text or video, shorter wait times and longer face-to-face visits. And they generally don't accept insurance, thus eliminating the need to chase bills and treatment authorizations.
"In my old practice, we spent almost half our time collecting payments. I thought if we could just get rid of all that overhead, we could spend more time with patients — and it proved true," said Dr. Bob Forester, the conceptual father and co-founder of St. Luke's, who retired earlier this year.
Many direct primary care docs scoff at the high-tech investor-owned firms such as One Medical and Forward Health. They are widely viewed as direct primary care companies, but critics say they are more focused on expanding volume than on offering personalized service.
"Direct primary care is where a physician has a relationship with a patient. We do not have to be accountable to an investor, because our investors are our patients," said Dr. Maryal Concepcion, a family doctor in the remote mountain town of Arnold, California, who recently left a commercial practice to launch her own one-woman direct primary care practice.
St. Luke's paid patients must have insurance to cover hospitalization, surgeries, specialty care, imaging and prescription drugs.
The clinic is often able to find steep discounts for its uninsured patients. For example, Quest Diagnostics charges them only 10% to 15% of its regular price for lab work, said Dr. R.J. Heck, one of the two family physicians at St. Luke's and co-founder of the clinic. It often refers uninsured patients who need operations to Cirugía sin Fronteras, a reduced-rate surgery center in Bakersfield.
St. Luke's recently got a $75,000 grant for imaging, lab tests, X-rays and some prescription drugs from the Legacy Health Endowment, a local foundation. And it works with several radiology groups that provide discounts, Heck said.
Tiznado, who needs periodic ultrasounds for her ovarian cysts, said she pays around $150 for them. "If I did it in another place, it would cost between $900 and $1,200," she said.
St. Luke's nonprofit tax-exempt status encourages donations, including from local corporate benefactors such as Foster Farms and winemaker E. & J. Gallo. Some workers at donor companies are among St. Luke's uninsured patients.
Tax-exempt status also confers a benefit on paying patients: They can take a tax deduction on the portion of their annual fees they don't use for medical care. Every year, St. Luke's sends them a statement that puts a dollar value, based on Medicare prices, on the services they received.
Forester said St. Luke's arose from his concern for the uninsured and his disdain for bureaucratic systems. But "the bottom line," he said, "is that the idea for St. Luke's came in an inspired moment of prayer." He and Heck launched it over 17 years ago as a Catholic-inspired medical office.
However, while Catholic symbols adorn the walls of St. Luke's, many of its patients are not Christian, and Catholic medical doctrine is not central to its practice.
"There's nobody coming in here and looking or telling us what we should or shouldn't do," said Dr. Erin Kiesel, the clinic's other family doctor.
Kiesel said she wouldn't prescribe an abortion, but she would tell somebody where to go if they asked — which nobody has.
Heck and Kiesel took big pay cuts to come to St. Luke's. Kiesel makes about $60,000 less a year than in her previous practice. Having more time with patients, less paperwork and better work-life balance more than offsets the lower pay, she said.
Patients cited the personal relationships they've built with their St. Luke's providers.
Paul Neumann, a patient of Heck's for 25 years who followed him to St. Luke's, said that relationship has been a godsend.
He told of returning from a trip to Rome in 2009 with a case of walking pneumonia. When his wife called Heck the next morning, he came to the house immediately.
Neumann, 84, pays St. Luke's well north of $10,000 a year for himself, his wife and his son's family.
"I'd be happy to write a check twice as large," he said.
On a recent morning, Jerrad Dinsmore and Kevin LeCaptain of Waldoboro EMS in rural Maine drove their ambulance to a secluded house near the ocean, to measure the clotting levels of a woman in her 90s.
They told the woman, bundled under blankets to keep warm, they would contact her doctor with the result.
"Is there anything else we can do?" Dinsmore asked.
"No," she said. "I'm all set."
This wellness check, which took about 10 minutes, is one of the duties Dinsmore and LeCaptain perform in addition to the emergency calls they respond to as staffers with Waldoboro Emergency Medical Service.
EMS crews have been busier than ever this year, as people who delayed getting care during the COVID-19 pandemic have grown progressively sicker.
But there's limited workforce to meet the demand. Both nationally and in Maine, staffing issues have plagued the EMS system for years. It's intense work that takes a lot of training and offers low pay. The requirement in Maine and elsewhere that paramedics and emergency medical technicians be vaccinated against COVID is another stress on the workforce.
Dinsmore and LeCaptain spend more than 20 hours a week working for Waldoboro on top of their full-time EMS jobs in other towns. It's common in Maine for EMS staffers to work for multiple departments, because most EMS crews need the help — and Waldoboro may soon need even more of it.
The department has already lost one EMS worker who quit because of Maine's COVID vaccine mandate for healthcare workers, and may lose two more.
The stress of filling those vacancies keeps Town Manager Julie Keizer awake at night.
"So, we're a 24-hour service," Keizer said. "If I lose three people who were putting in 40 hours or over, that's 120 hours I can't cover. In Lincoln County, we already have a stressed system."
The labor shortage almost forced Waldoboro to shut down ambulance service for a recent weekend. Keizer said she supports vaccination but believes Maine's decision to mandate it threatens the ability of some EMS departments to function.
Maine is one of 10 states that require healthcare workers to get vaccinated against COVID or risk losing their jobs. Along with Oregon, Washington and Washington, D.C., it also explicitly includes the EMTs and paramedics who respond to 911 calls in that mandate. Some ambulance crews say it's making an ongoing staffing crisis even worse.
Two hundred miles north of Waldoboro, on the border with Canada, is Fort Fairfield, a town of 3,200. Deputy Fire Chief Cody Fenderson explained that two workers got vaccinated after the mandate was issued in mid-August, but eight quit.
"That was extremely frustrating," Fenderson said.
Now Fort Fairfield has only five full-time staffers available to fill 10 slots. Its roster of per-diem workers all have full-time jobs elsewhere, many with other EMS departments that are also facing shortages.
"You know, anybody who does ambulances is suffering," said Fenderson. "It's tough. I'm not sure what we're going to do, and I don't know what the answer is."
In Maine's largest city, Portland, the municipal first-responder workforce is around 200 people, and eight are expected to quit because of the vaccine mandate, according to the union president for firefighters, Chris Thomson.
That may not seem like a significant loss, but Thomson said those are full-time positions and those vacancies will have to be covered by other employees who are already exhausted by the pandemic and working overtime.
"You know, the union encourages people to get their vaccine. I personally got the vaccine. And we're not in denial of how serious the pandemic is," Thomson said. "But the firefighters and the nurses have been doing this for a year and a half, and I think that we've done it safely. And I think the only thing that really threatens the health of the public is short staffing."
Thomson maintains that unvaccinated staffers should be allowed to stay on the job because they're experts in infection control and wear personal protective equipment such as masks and gloves.
But Maine's public safety commissioner, Mike Sauschuck, said EMS departments also risk staff shortages if workers are exposed to COVID and have to isolate or quarantine.
"Win-win scenarios are often talked about but seldom realized," he said. "So sure, you may have a situation where staffing concerns are a reality in communities. But for us, we do believe the broader impact, the safer impact on our system is through vaccination."
Some EMS departments in Maine have complied fully with the mandate, with no one quitting. Andrew Turcotte, the fire chief and director of EMS for the city of Westbrook, said all 70 members of his staff are now vaccinated. He doesn't see the new mandate as being any different from the vaccine requirements to attend school or enter the healthcare field.
"I think that we all have not only a social responsibility but a moral one," Turcotte said. "We chose to get into the healthcare field, and with that comes responsibilities and accountabilities. That includes ensuring that you're vaccinated."
Statewide numbers released last week show close to 97% of EMS workers in Maine have gotten vaccinated. But that varies by county: Rural Piscataquis and Franklin counties reported that 18% and 10% of EMS employees, respectively, were still unvaccinated as of mid-October.
Not all EMS departments have reported their vaccination rates to the state. Waldoboro is in Lincoln County, where only eight of 12 departments have reported their rates. Among those eight, the rate of noncompliance was just 1.6%.
But in small departments like Waldoboro, the loss of even one staff member can create a huge logistical problem. Over the past few months, Waldoboro's EMS director, Richard Lash, started working extra long days to help cover the vacancies. He's 65 and is planning to retire next year.
"I've told my town manager that we'll do the best we can do. But, you know, I can't continue to work 120 hours a week to fill shifts," said Lash. "I'm getting old. And I just can't keep doing that."
Nursing homes receive billions of taxpayers' dollars every year to care for chronically ill frail elders, but until now, there was no guarantee that's how the money would be spent.
Massachusetts, New Jersey and New York are taking unprecedented steps to ensure they get what they pay for, after the devastating impact of COVID-19 exposed problems with staffing and infection control in nursing homes. The states have set requirements for how much nursing homes must spend on residents' direct care and imposed limits on what they can spend elsewhere, including administrative expenses, executive salaries and advertising and even how much they can pocket as profit. Facilities that exceed those limits will have to refund the difference to the state or the state will deduct that amount before paying the bill.
The states' mandates mark the first time nursing homes have been told how to spend payments from the government programs and residents, according to Cindy Mann, who served as Medicaid chief in the Obama administration.
With this strategy, advocates believe, residents won't be shortchanged on care, and violations of federal quality standards should decrease because money will be required to be spent on residents' needs. At least that's the theory.
"If they're not able to pull so much money away from care and spend it on staffing and actual services, it should make a big difference," said Charlene Harrington, professor emeritus at the University of California-San Francisco's School of Nursing who has spent four decades studying nursing home reimbursement and regulation. "I would expect the quality of care would improve substantially."
"The actual effect will be just the opposite," said Andrew Aronson, president and CEO of the Healthcare Association of New Jersey. "By trying to force providers to put more money into direct care, you're creating a disincentive for people to invest in their buildings, which is going to drive the quality down."
Next year, New York's nursing facilities will have to spend at least 70% of their total revenue —including payments from Medicaid, Medicare and private insurers — on resident care and at least 40% of that direct-care spending must pay for staff members involved in hands-on care. In Massachusetts, Gov. Charlie Baker issued rules requiring nursing homes have to spend at least 75% of all revenue on residents' care. New Jersey's law requires its nursing homes to spend at least 90% of revenue on patient care. But its state regulators have proposed that the requirement apply only to Medicaid funding. No final determination has been made.
All three states promise a boost in Medicaid payments to facilities that comply with the laws.
Harrington and other advocates say the measures are well overdue, but they are watching how regulators in each state define direct care, who qualifies as a direct care worker, what counts as revenue and whether it is reported accurately.
Jim Clyne, president and CEO of LeadingAge New York, which represents nonprofit nursing facilities, questions the legality of some provisions in New York's law. "I don't think there's any doubt that it will end up in court," he said.
Aronson said the mandate is based on a misconception — that nursing homes could have kept COVID-19 out of their facilities if they had only marshaled their resources properly. "As long as COVID is in our communities, it will also find its way into our facilities," he said.
But poor infection control practices resulting from inadequate staffing have been the most common violation cited by nursing home inspectors over the years, according to a study released last year by the federal Government Accountability Office. The pandemic did little to change that trend. In August 2020, a frustrated Seema Verma, then-administrator of the Centers for Medicare & Medicaid Services, warned nursing home operators that "significant deficiencies in infection control practices" were responsible for increases in COVID deaths and pleaded with them "to really double down on those practices."
"Philosophically, if a payer wants to tell the provider how to use their funds within certain parameters, I understand that, but that's not what the [New York] law does," said Clyne. "The law goes beyond that. The state is telling the provider how much of other people's money they have to spend on care also, not just the state's money."
Bills paid by Medicare or individuals should be excluded from the state mandate, along with Medicaid funds earmarked for certain purposes such as mortgage expenses, he said.
Medicaid, funded under a state and federal government partnership, provides health insurance to low-income people and typically pays for about 60% of the nursing home care nationwide, usually for long-term residents with chronic health problems. Medicare, funded by federal dollars, insures older or disabled adults, and provides about 16% of facilities' revenue. The rest comes from private Medicare Advantage and other health insurance companies, and individuals who pay for their own care.
"Nursing homes are primarily funded by public tax dollars, Medicaid or Medicare — and the public has a reason to care about how our dollars are being spent," said Milly Silva, executive vice president of 1199SEIU, the union that represents 45,000 nursing home workers in New York and New Jersey, and backed the legislation in both states.
The spending mandates are not a new idea for healthcare. The Affordable Care Act directs health insurers to spend at least 80 cents of every dollar in premiums to pay for beneficiaries' healthcare needs. What remains can be spent on administrative costs, executive salaries, advertising and profits. Companies that exceed the limit must refund the difference to beneficiaries.
Harrington disagrees with industry officials who want to exclude Medicare dollars from the calculation of how much nursing homes must spend on direct care. That would leave a large source of profits untouched, she said, and allow them to use that money "however you want."
Medicare paid nursing homes $27.8 billion in fiscal year 2019, according to the Medicare Advisory Payment Commission, an independent panel appointed by Congress.
Even if only the Medicaid money is affected, though, there's still a big problem in the direct care spending mandate, said Aronson. "Ninety percent of facilities are losing money," he said, because Medicaid payments don't cover the cost of care. In New Jersey, he added, the shortfall is $40 a day per resident.
But some state lawmakers are not convinced. "Medicaid payments may not fully cover the cost of care, but somehow for-profit nursing homes are making money," said New York state lawmaker Richard Gottfried, who has chaired the Assembly health committee since 1987. More than two-thirds of the state's nursing homes operate as for-profit businesses and have been able to hide some of those profits in associated businesses they also own and then hire, he said. They can "use real estate gimmicks and shell contracts to make it look like they're spending money when what they are really doing is just siphoning income into their own pockets," he said. The use of such "related parties" payments has occurred across the country for several years.
To uncover the facilities' true income and expenses, the state mandates require accurate documentation. "If they file false documentation, that will be a felony," said Gottfried.
The spending mandates come at a challenging time for the industry, which is still recovering from the worst of the pandemic and facing a staffing shortage and low occupancy. But New York Assembly member Ron Kim, whose uncle died in a nursing home from presumed COVID, said lawmakers should be able to tell nursing home operators how to spend taxpayers' money. "If they choose to rely on public dollars to deliver care, they take on a greater responsibility," he said. "It's not like running a hotel."
This article was published on Monday, October 25, 2021 in Kaiser Health News.
VIRGINIA CITY, Mont. — Emilie Sayler's roots run deep in southwestern Montana. She serves on a nearby town council and the board of the local Little League. She went to college in a neighboring county and regularly volunteers in the schools of her three kids.
Just a few months into her new job as public health director for Madison County, she had hoped that those local connections might make a difference, that the fewer than 10,000 residents spread out across this agricultural region would see her familiar face and support her efforts to curtail the COVID-19 pandemic raging here.
That largely hasn't happened. School boards have rebuffed even minor measures to prevent outbreaks, vaccination rates languish and the Centers for Disease Control and Prevention categorizes infection levels in the rural county as high. Parents, Sayler said, are sending sick kids to school.
On top of that, a resident phoned her office and told a member of her staff, "I wish that you would get COVID and die."
"People have used the term 'free-for-all,' and I really hate to admit that that's what it kind of feels like," Sayler said.
Nationally, KHN and The Associated Press have documented that more than 300 public health leaders, weary of abuse and of their expertise being questioned, have resigned or retired as the country struggles to recover from the worst pandemic in a century. They have been replaced by people like Sayler, often inexperienced yet tasked with repairing the trust of a polarized and fatigued public.
At least 26 states have passed laws or regulations limiting the powers of public health officers this year, meaning these replacements have fewer tools and less authority than their predecessors to enforce their orders and recommendations.
Lori Christenson is the new health officer for Gallatin County, Madison County's neighbor to the east and home of the city of Bozeman and Montana State University. In June, she replaced Matt Kelley, who before resigning had become a political punching bag as the county mandated masks in public places and restricted business hours and the size of crowds. Protesters on social media demanded his ouster; a few picketed outside his home. Christenson had served in the health department for seven years before her promotion and worked closely with Kelley.
While her office still hears daily from frustrated citizens "on both sides," she said the vitriol is not quite as malicious as in the past. That's in large part, she believes, because the new laws that gutted her department's power shifted criticism to other entities like local school boards that still have the authority to mandate measures such as wearing masks.
"Sometimes it can be pretty frustrating not having the ability to make some immediate changes that previously helped to slow transmission," Christenson said. "We just don't have the tools at our disposal in the same way that we did before."
That reality, she said, has been "morally challenging."
"I have a duty to protect the community. You want to do what is right, but you also want to do what is lawful. In this situation, it didn't mesh."
Joe Russell does not envy health officers new to their positions. He retired as head of the Flathead City-County Health Department in 2017 but returned in December after the interim director resigned over what she called a "toxic environment" inflamed by the "ideological biases" of local politicians.
"Think about going into a brand-new profession, in a leadership role that you've never held, in a crisis like COVID-19," Russell said. "It would be miserable."
He said his experience — 30 years in the Flathead health department, including 20 as its leader — has eased navigating through the pandemic in one of the state's most populous and conservative counties, although the rate of cases there remains high and its vaccination rate low.
His tenure, he said, has given him the credibility to confront officials who question the seriousness of COVID or the safety and effectiveness of vaccines.
"When someone spouts this nonsense, who better to stand up and give them the science-based evidence and tell them that they are full of crap?" Russell said. "I love it when that happens at a public meeting."
Although Montana laws essentially prevent public health officials from following many CDC guidelines, Christenson said they still have useful tools available to combat the virus: testing, contact tracing, vaccination, communicating with the public.
"That is what I focus on," she said. "That is what we can do."
Christenson believes she has the community's support. She noted that while a few people protested outside of Kelley's home, crowds countered that criticism by lining Bozeman's Main Street, offering cheers of support on his drive home.
"Not to say that every day is rosy," she said. "That would be naive. But you can feel the staff here continue to try to move forward, and that to me is a success."
In Madison County, Sayler said she is taking an "olive branch" approach to turning things around, advancing recommendations rather than orders, as her staff works to nudge vaccination rates up from the current 48%. She's doubtful that will quickly reduce COVID.
In September, the county saw approximately 200 new cases — roughly 20% of all its infections since the pandemic began — and had more residents hospitalized with the virus than ever before.
While the pandemic has filled Sayler's first months on the job, she said she looks forward to focusing on other ways the health department can restore the public's faith and help Madison County, such as offering car seats for babies or nutrition advice for expectant mothers.
"There is a lot of rebuilding to do here, because this whole office has been consumed by COVID for so long," she said. "I can still see long-term goals for us and what we can do for this community. That's not just a goal. That's a need."
Her office has on occasion persuaded those sick with COVID, even those who insisted the virus is not serious, to seek medical help. "Tell your story," Sayler said she advises those COVID survivors. "Make sure everybody knows how sick you were."
But then there are more difficult encounters, such as when a mother cursed her out over the phone about the recommendation that her child be quarantined. A week later, she saw the woman at her daughter's volleyball game.
"She was sitting there and looked directly at me and then looked away," Sayler said. "That made me feel better. You truly don't feel that way. You were just expressing frustration in that moment."
That experience left her with cautious optimism about the difficult task she has ahead with the pandemic set to enter its second winter.
"It is reassuring that there is potential here. We can still work with these people," she said. "We just really don't want to be a punching bag, either."
After four people were murdered in one week in early September — all in the same Washington, D.C., neighborhood — residents made a plea for help.
"We've been at funerals all week," said Janeese Lewis George, a City Council member who represents the neighborhood. "What can we do as a community?"
She was speaking to dozens of people at a vigil site, a tree adorned with teddy bears and candles along a street lined with rowhouses. According to police, the area, known as Brightwood Park, has been plagued by several dozen violent, gun-related crimes over the past year. When Lewis George asked whether the crowd had known anyone who'd been shot, most people raised their hands.
Earlier that day, five council members joined Lewis George in asking Mayor Muriel Bowser for assistance — not in the form of more police, but from the city's first-ever gun violence prevention director, Linda Harllee Harper.
Harllee Harper knows Brightwood Park, having grown up near the heavily Black and Latino neighborhood, which has recently begun to attract white residents, too. She knows the local stories, both good and bad. Some families have lived there for decades, witnessing generational poverty and government neglect. During the 1990s, parts of it were considered a "war zone" because of rampant drug- and gang-related activity. She still lives in the same ward with her husband and son, who plays basketball at the local recreation center with the children of a recent murder victim.
Her investment in finding a solution is clear. "It's not a new development," Harllee Harper told KHN. "My view of gun violence is shaped by how much loss I've experienced. I've had friends who have been killed and I also have had young people that I have worked with be killed."
D.C. began 2021 with two crises: the coronavirus pandemic and a gun violence epidemic. To respond to the latter, Bowser advanced plans to draw on lessons learned from the former. She started by creating a position, one that anti-gun violence groups had long requested and became too urgent to ignore: gun violence prevention director. Enter Harllee Harper, who was appointed Jan. 28.
About three weeks later, the mayor declared a public health emergency over gun violence and created an "emergency operations center" that mirrored the city's COVID-19 response. No part of the U.S. has been spared from an increase in murders during the pandemic. And in the nation's capital the murder toll is outpacing last year's, which reached 198, a 16-year high. Per capita, that's about 29 murders per 100,000 residents.
Harllee Harper, 56, started her 20-plus-year career at D.C. Public Schools as a substance abuse prevention and intervention coordinator. Most recently, she was senior deputy director for the D.C. Department of Youth Rehabilitation Services, where she helped overhaul the agency.
"I've run programs before, but this was a different level of limelight" than something she would have signed up for on her own, she said.
Nine months into this new role, Harllee Harper's most powerful tool is the mayor's initiative, Building Blocks. Drawing on public health strategies to contain the spread of gun violence, it's designed to treat the immediate symptoms and root causes of community violence.
Its workers operate almost as contact tracers, whose methods have become familiar during the pandemic. They enter targeted communities to form relationships and connect high-risk residents to violence interrupters, who are trained to de-escalate conflict. They also arrange for resources, like drug addiction treatment and housing assistance. The idea is to reach the small number of people who engage in dangerous behavior and invest in them and their neighborhood.
"Hopelessness combined with a gun, combined with substance abuse, is a really bad combination. And I think that's what we are seeing right now," said Harllee Harper.
Building Blocks is up and running in about a third of its targeted 151 blocks — 2% of the city — that were connected to 41% of last year's gunshot-related crimes last year. (Brightwood Park is not on this list but is included in the city's fall crime prevention initiative run by the police department.)
These diverse neighborhoods are home to people who tend to be poorer and lack access to resources and opportunities. Statistics among COVID and murder victims look similar: The same neighborhoods were hit hardest and the vast majority of deaths have befallen Black people.
D.C. stemmed the spread of COVID far more efficiently than the nation as a whole, in part through government action. The city's crash course on public health during the pandemic could mean it's better situated to address gun violence. "We can explain certain things through this public health lens and people can understand it a bit better," said David Muhammad, executive director of the National Institute for Criminal Justice Reform.
He said D.C.'s approach is unique and Harllee Harper's position is rare. "If you claim to want to reduce gun violence in your city, prove it. Whose full-time job is it in your city to do that? In most cities, it is zero," he said. "Don't tell me the police chief. That's a small portion of their job."
For the few dozen cities that have some sort of anti-violence czar, the position is relatively new. Richmond, California, is an exception, with an agency dedicated to reducing gun violence since 2008. Richmond's Office of Neighborhood Safetyhas been heralded as a model. By 2013, Richmond went from more than 40 homicides a year to 16, according to Giffords Law Center to Prevent Gun Violence — its lowest number in three decades.
Harllee Harper's position is housed not within the public safety agency but the city administrator's office, presumably affording her more authority and oversight of government programs.
And Building Blocks created a mobile app with which its employees can flag requests during walk-throughs of select neighborhoods. An employee could make a request using the city's "311" service line to repair a streetlight that is out, for example, and the agency responsible would prioritize it because it came from Building Blocks.
There's no guarantee these interventions will work, though multiple studies have shown positive outcomes of violenceinterrupters or infrastructure improvements, such as cleaning and transforming vacant lots and abandoned buildings.
But Daniel Webster, director of the Johns Hopkins Center for Gun Violence Prevention and Policy in Baltimore, said it's important to track successes and failures because efforts like the one Harllee Harper is spearheading don't "always work in all places" and there are lessons to learn when they don't.
"We can't expect the workers to just perform miracles," said Webster.
While expectations are high, Harllee Harper's success depends on whether government and business leaders will respond with the same urgency as they did when the health director requested action.
"The biggest hurdle really is getting all of government to buy into a new day and a new way to get things done," said council member Charles Allen, who chairs a committee that created Harllee Harper's position. "Bureaucracy is not nimble."
"My colleagues in the sister agencies across the city, when Building Blocks calls, they are very, very responsive," said Harllee Harper. "We're working together to create performance metrics for agencies related to gun violence prevention."
Some residents remain skeptical. Residents of the first Building Blocks neighborhood said the follow-up continues to lag. Jamila White, an elected member of the Advisory Neighborhood Commission, said she had several conversations with Harllee Harper and gave her a tour to point out the needs, including quick fixes like adding or fixing streetlights and regular street-sweeping. White has yet to see expedited results, she said, but respects Harllee Harper and admits that no one could address all the issues, many rooted in poverty, alone.
"There's a lot of shared agreement. But you know, having a shared agreement and having political will and power to do something is a different thing," said White.
ATHENS, Ga. — Melissa Lee had more to deal with than funeral planning when her husband, Dan Lee, died by suicide in January. She also was faced with continuing Dan's 1,400-member Facebook group, "Athens, GA Mask Grades 2.0," designed to help residents of Athens protect themselves from COVID-19 by grading local businesses on their safety measures.
The group follows a strict template that Melissa Lee compares to a Yelp review. The review includes information about a company's physical distancing provisions, the availability of outdoor services, vaccination requirements, and the percentages of masked employees and customers.
"A mask is like a visible sign of whether or not you're listening to the same information," said Lee, who works in donor relations at the University of Georgia. "There is some beauty in supporting those that are aligned with you. But it's also just kind of sad that there's two sides to that."
COVID vigilantes like the Lees have cropped up in multiple cities, appearing where safety guidelines are lax despite high numbers of positive cases.
Some states, such as Florida, go as far as preventing local safety mandates, though the Sunshine State has been sued by a group of parents for banning strict mask mandates in schools.
In Georgia, although Republican Gov. Brian Kemp declared a state of emergency due to COVID, no state mask mandate exists. An executive order allows businesses to disregard the COVID safety ordinances created by local governments requiring masks.
Similarly, in Tennessee, Republican Gov. Bill Lee issued an executive order that prevents local mask orders in 89 counties.
These states stand in sharp contrast to those with definitive policies, such as California, where masks are required in hospitals, schools and correctional facilities, regardless of vaccination status.
The lack of government action in some communities is forcing everyday people to fill the void, according to Imran Ahmed, CEO of the Center for Countering Digital Hate, an international nonprofit organization designed to disrupt online misinformation.
"You can see here that people are taking action collectively, essentially replicating what governments should be doing, but in a private fashion out of sheer desperation," Ahmed said.
With about 6,800 members, Alabama-based "Mask Up Huntsville" says its mission is to track the mask compliance of local businesses. Alabama currently recommends wearing a mask indoors but has no mandate. In the public Facebook group, people can also ask for recommendations from others about which doctors and dentists follow responsible COVID guidelines, and they can share personal anecdotes about pandemic life. But what isn't allowed: political statements of any kind.
In Tennessee, a perceived lack of information from government authorities led to a private Facebook group called "Knoxville Parents Against COVID." Amanda Jamison Gillen created the group to allow parents to report if their child tests positive for COVID, as an alert to other parents amid a vacuum of information at the time from the schools.
Knox County Schools recommended the use of face masks in 2020 but did not require them when classes resumed in August. In late September, however, the school district updated its COVID policy following an injunction by a district judge. It now requires masks for all students, staffers and visitors, and students are required to isolate if they test positive for COVID.
Chyna Brackeen joined the Knoxville group the day it was created. She became one of the group's administrators about a week later to help handle its rapid growth and check for misinformation.
"One of the major reasons we decided to require moderator approval of posts was so that conspiracy theories wouldn't run rampant," Brackeen said.
Misinformation about COVID is persistent online, but Ahmed said it is not the impetus for creating such groups. The sheer amount of information online can make it hard to tell what's true. This overabundance of information has "trapped tens of millions of Americans in an alternative world in which horse dewormer shoved up your bum can fix COVID," he said.
Arthur Caplan, a professor of bioethics at New York University's Grossman School of Medicine in New York City, said community-based COVID-safety social media groups help provide balance.
"Social media has become a kind of cesspool for the crazy," Caplan said. "I like using it as a place where you could really protect yourself, your kids, try to form communities that are trying to do the right thing, rather than undermine public health efforts."
Dan Lee started the Athens page after being inspired by the efforts in Huntsville. His public page reached over 2,000 members before being reported by Facebook users who disagreed with the group's messaging. He created a private "2.0" version as a workaround.
Dan had a history of mental health issues, and the pandemic may have made matters worse, Melissa Lee said. "That year of boiling society could have very well affected his mental health," she said. "It clearly bothered him."
Dan and Melissa Lee, with dog Hubble, outside their Athens, Georgia, home in 2020. Until Dan's death in January, the two served as initial moderators for the "Athens, GA Mask Grades 2.0" Facebook group, designed to compile information on local businesses' COVID safety measures.(George Lee)
But members continued his work, stepping up as volunteer administrators for the site after his suicide, she said. While it's difficult to track, the Facebook group may be having a larger impact.
For example, in August, a group member posted about Earth Fare, a grocery store chain that did not support mask mandates. Two days after being called out on social media, Earth Fare Athens posted the following on Facebook: "We whole heartedly agree with the concerns mentioned. Effective immediately, we will be following all locally mandated guidelines." The company declined to comment for this story.
Facebook and other social media platforms may be valuable in amplifying and endorsing public health recommendations, said Glen Nowak, co-director of the Center for Health & Risk Communication at the University of Georgia. "The broad idea is to show people who are in favor of something that there are other people who are also in favor, that you're not alone."
Still, Nowak said, there is a need to proceed with caution, especially when it comes to specific scientific questions. "The value of these groups is in sharing experiences," he said. "It's hard to rely on non-expert sources for questions that really mostly involve science or medicine."
There's also concern that online groups are not widely accessible beyond communities that are white, educated and savvy with social media, Caplan noted.
"The usual obstacles are out there for poor people who might be sympathetic but don't have internet access," he said. Or those who "don't feel comfortable getting into a discussion group that's almost exclusively white."
Yet in the absence of COVID safety mandates, groups like these prove useful to consumers such as Travis Henry. It helps him make informed decisions.
"I don't want to know about aggregate trends about every grocery store in America," Henry said. "I want to know about the half-dozen that I can drive to, and which one has the largest percentage of people who are masked, or which one has put up plexiglass windows."
Need Help?
If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-8255 or text HOME to the Crisis Text Line at 741741.
Like most other kids with COVID, Dante and Michael DeMaino seemed to have no serious symptoms.
Infected in mid-February, both lost their senses of taste and smell. Dante, 9, had a low-grade fever for a day or so. Michael, 13, had a "tickle in his throat," said their mother, Michele DeMaino, of Danvers, Massachusetts.
At a follow-up appointment, "the pediatrician checked their hearts, their lungs, and everything sounded perfect," DeMaino said.
Then, in late March, Dante developed another fever. After examining him, Dante's doctor said his illness was likely "nothing to worry about" but told DeMaino to take him to the emergency room if his fever climbed above 104.
Two days later, Dante remained feverish, with a headache, and began throwing up. His mother took him to the ER, where his fever spiked to 104.5. In the hospital, Dante's eyes became puffy, his eyelids turned red, his hands began to swell and a bright red rash spread across his body.
More than 5,200 of the 6.2 million U.S. children diagnosed with COVID have developed MIS-C. About 80% of MIS-C patients are treated in intensive care units, 20% require mechanical ventilation, and 46 have died.
Throughout the pandemic, MIS-C has followed a predictable pattern, sending waves of children to the hospital about a month after a COVID surge. Pediatric intensive care units — which treated thousands of young patients during the late-summer delta surge — are now struggling to save the latest round of extremely sick children.
Doctors have no way to prevent MIS-C, because they still don't know exactly what causes it, said Dr. Michael Chang, an assistant professor of pediatrics at Children's Memorial Hermann Hospital in Houston. All doctors can do is urge parents to vaccinate eligible children and surround younger children with vaccinated people.
Although most children who develop MIS-C were previously healthy,80% develop heart complications. Dante's coronary arteries became dilated, making it harder for his heart to pump blood and deliver nutrients to his organs. If not treated quickly, a child could go into shock. Some patients develop heart rhythm abnormalities or aneurysms, in which artery walls balloon out and threaten to burst.
"It was traumatic," DeMaino said. "I stayed with him at the hospital the whole time."
Such stories raise important questions about what causes MIS-C.
"It's the same virus and the same family, so why does one child get MIS-C and the other doesn't?" asked Dr. Natasha Halasa of the Vanderbilt Institute for Infection, Immunology and Inflammation.
Researchers at Boston Children's Hospital and other institutions are looking for clues in children's genes.
In a July study, the researchers identified rare genetic variants in three of 18 children studied. Significantly, the genes are all involved in "removing the brakes" from the immune system, which could contribute to the hyperinflammation seen in MIS-C, said Dr. Janet Chou, chief of clinical immunology at Boston Children's, who led the study.
Chou acknowledges that her study — which found genetic variants in just 17% of patients — doesn't solve the puzzle. And it raises new questions: If these children are genetically susceptible to immune problems, why didn't they become seriously ill from earlier childhood infections?
Others note that rates of MIS-C mirror the higher COVID rates in these communities, which have been driven by socioeconomic factors such as high-risk working and living conditions.
"I don't know why some kids get this and some don't," said Dr. Dusan Bogunovic, a researcher at the Icahn School of Medicine at Mount Sinai who has studied antibody responses in MIS-C. "Is it due to genetics or environmental exposure? The truth may lie somewhere in between."
A Hidden Enemy and a Leaky Gut
Most children with MIS-C test negative for COVID, suggesting that the body has already cleared the novel coronavirus from the nose and upper airways.
That led doctors to assume MIS-C was a "postinfectious" disease, developing after "the virus has completely gone away," said Dr. Hamid Bassiri, a pediatric infectious diseases specialist and co-director of the immune dysregulation program at Children's Hospital of Philadelphia.
Now, however, "there is emerging evidence that perhaps that is not the case," Bassiri said.
Even if the virus has disappeared from a child's nose, it could be lurking — and shedding — elsewhere in the body, Chou said. That might explain why symptoms occur so long after a child's initial infection.
Dr. Lael Yonker noticed that children with MIS-C are far more likely to develop gastrointestinal symptoms — such as stomach pain, diarrhea and vomiting — than the breathing problems often seen in acute COVID.
In some children with MIS-C, abdominal pain has been so severe that doctors misdiagnosed them with appendicitis; some actually underwent surgery before their doctors realized the true source of their pain.
Yonker, a pediatric pulmonologist at Boston's MassGeneral Hospital for Children, recently found evidence that the source of those symptoms could be the coronavirus, which can survive in the gut for weeks after it disappears from the nasal passages, Yonker said.
In a May study in The Journal of Clinical Investigation, Yonker and her colleagues showed that more than half of patients with MIS-C had genetic material — called RNA — from the coronavirus in their stool.
The body breaks down viral RNA very quickly, Chou said, so it's unlikely that genetic material from a COVID infection would still be found in a child's stool one month later. If it is, it's most likely because the coronavirus has set up shop inside an organ, such as the gut.
While the coronavirus may thrive in our gut, it's a terrible houseguest.
In some children, the virus irritates the intestinal lining, creating microscopic gaps that allow viral particles to escape into the bloodstream, Yonker said.
Blood tests in children with MIS-C found that they had a high level of the coronavirus spike antigen — an important protein that allows the virus to enter human cells. Scientists have devoted more time to studying the spike antigen than any other part of the virus; it's the target of COVID vaccines, as well as antibodies made naturally during infection.
"We don't see live virus replicating in the blood," Yonker said. "But spike proteins are breaking off and leaking into the blood."
Viral particles in the blood could cause problems far beyond upset stomachs, Yonker said. It's possible they stimulate the immune system into overdrive.
In her study, Yonker describes treating a critically ill 17-month-old boy who grew sicker despite standard treatments. She received regulatory permission to treat him with an experimental drug, larazotide, designed to heal leaky guts. It worked.
Yonker prescribed larazotide for four other children, including Dante, who also received a drug used to treat rheumatoid arthritis. He got better.
But most kids with MIS-C get better, even without experimental drugs. Without a comparison group, there's no way to know if larazotide really works. That's why Yonker is enrolling 20 children in a small randomized clinical trial of larazotide, which will provide stronger evidence.
Rogue Soldiers
Dr. Moshe Arditi has also drawn connections between children's symptoms and what might be causing them.
Although the first doctors to treat MIS-C compared it to Kawasaki disease — which also causes red eyes, rashes and high fevers — Arditi notes that MIS-C more closely resembles toxic shock syndrome, a life-threatening condition caused by particular types of strep or staph bacteria releasing toxins into the blood. Both syndromes cause high fever, gastrointestinal distress, heart muscle dysfunction, plummeting blood pressure and neurological symptoms, such as headache and confusion.
Toxic shock can occur after childbirth or a wound infection, although the best-known cases occurred in the 1970s and '80s in women who used a type of tampon no longer in use.
Toxins released by these bacteria can trigger a massive overreaction from key immune system fighters called T cells, which coordinate the immune system's response, said Arditi, director of the pediatric infectious diseases division at Cedars-Sinai Medical Center.
T cells are tremendously powerful, so the body normally activates them in precise and controlled ways, Bassiri said. One of the most important lessons T cells need to learn is to target specific bad guys and leave civilians alone. In fact, a healthy immune system normally destroys many T cells that can't distinguish between germs and healthy tissue in order to prevent autoimmune disease.
In a typical response to a foreign substance — known as an antigen — the immune system activates only about 0.01% of all T cells, Arditi said.
Toxins produced by certain viruses and the bacteria that cause toxic shock, however, contain "superantigens," which bypass the body's normal safeguards and attach directly to T cells. That allows superantigens to activate 20% to 30% of T cells at once, generating a dangerous swarm of white blood cells and inflammatory proteins called cytokines, Arditi said.
This massive inflammatory response causes damage throughout the body, from the heart to the blood vessels to the kidneys.
Although multiple studies have found that children with MIS-C have fewer total T cells than normal, Arditi's team has found an explosive increase in a subtype of T cells capable of interacting with a superantigen.
Several independent research groups — including researchers at Yale School of Medicine, the National Institutes of Health and France's University of Lyon — have confirmed Arditi's findings, suggesting that something, most likely a superantigen, caused a huge increase in this T cell subtype.
Although Arditi has proposed that parts of the coronavirus spike protein could act like a superantigen, other scientists say the superantigen could come from other microbes, such as bacteria.
"People are now urgently looking for the source of the superantigen," said Dr. Carrie Lucas, an assistant professor of immunobiology at Yale, whose team has identified changes in immune cells and proteins in the blood of children with MIS-C.
Uncertain Futures
One month after Dante left the hospital, doctors examined his heart with an echocardiogram to see if he had lingering damage.
To his mother's relief, his heart had returned to normal.
Today, Dante is an energetic 10-year-old who has resumed playing hockey and baseball, swimming and rollerblading.
"He's back to all these activities," said DeMaino, noting that Dante's doctors rechecked his heart six months after his illness and will check again after a year.
Such rapid recoveries suggest that MIS-C-related cardiovascular problems result from "severe inflammation and acute stress" rather than underlying heart disease, according to the authors of the study, called Overcoming COVID-19.
DeMaino said she remains far more worried about Dante's health than he is.
"He doesn't have a care in the world," she said. "I was worried about the latest cardiology appointment, but he said, 'Mom, I don't have any problems breathing. I feel totally fine.'"