In 1972, just 18 days after he was selected to run for vice president with Democratic Sen. George McGovern, Thomas Eagleton was forced off the ticket. The issue? Years earlier, Eagleton had been hospitalized and treated with electroshock therapy for depression. The disclosure of his mental health history was a blow from which the Missouri senator could not recover.
Eagleton's torpedoed candidacy has been a cautionary tale for elected officials ever since, says California Superior Court Judge Tim Fall, who serves in Yolo County. But rather than remain quiet as he approached his own reelection season last year, Fall came out with a book that detailed his decades-long struggles with anxiety and depression.
As it turned out, Fall was unopposed for another six-year term in office. But it was a previous challenge for his seat, in 2008, that had triggered his most difficult bout with mental illness. That campaign forms the backdrop of "Running for Judge," which Fall said he wrote to show that struggling with mental illness doesn't disqualify people from high-pressure professions.
Fall, 61, who has a law degree from the University of California-Davis, was 35 when then-Gov. Pete Wilson, a Republican, appointed him as a municipal judge in 1995. Three years later he became a Superior Court judge for Yolo County; the 2008 election was the only time he ran opposed. Fall also teaches judicial ethics to other judges around the state.
He spoke with KHN in his chambers in Woodland, California. The interview has been edited for length and clarity.
Q: When did you realize you had a problem dealing with stress?
I'd been on the bench four or five years. I was leaving a committee meeting in the Bay Area for the California Judges Association, and I got to my car and started the engine, and all of a sudden my left shoulder and arm were numb. My first thought was a heart attack and my second thought was a stroke, but then the numbness diminished. The doctor said it was stress, and I said, "What do you mean, stress?" He said, "You don't get it. Your job is at a stress level that most people don't deal with, and you don't recognize it because you've been dealing with it for a few years now."
Q: That conversation with your doctor was 20-plus years ago.
Right. And it came to a head when I finally got a medical diagnosis regarding mental illness in 2008, after an attorney decided to run against me. The stress went to 11 immediately. It built upon itself and eventually got to where I would wake up at midnight and then stay awake for the night, feeling overwhelmed, feeling some depression, feeling some anxiety.
Q: Was it the idea of having to campaign for yourself that was the stressor?
Exactly. Some judges seem to thrive if challenged, and I'm happy for them. I speak in public regularly, but to do it when I was trying to keep my job was brand-new. The essential diagnosis was generalized anxiety disorder, with depressive episodes. We found some medication that worked for me, and that is important, because there are a lot of medications out there. Finding the right one and the right dosage is key.
Q: You wound up winning that 2008 election.
Handily. And the day after the election, I slept like a baby, and I woke up the next morning with absolutely no anxiety. It was the first time I'd had that kind of night's sleep and that kind of waking moment since the first day someone announced to run against me. But I've had recurring episodes of anxiety since then, mostly having to do with my father's health. Going back to my time in community college, I actually had a panic attack during an algebra final.
Q: Your father passed away in 2019. Then, in 2020, the pandemic hit.
And pandemic stress is real. We have pandemic rules in place, and it is my job to enforce those in my courtroom. Every morning, I'm reminding people how to wear a mask properly, and I am conducting remote appearances or in-court appearances. The level of attention that I have to give to things that people would say aren't normally a part of a judge's job is just very high.
Q: Why did you decide to make your story public?
The common statistics are that 20% to 25% of our population has anxiety or depression — or both. There are a little over 1,700 judges on the bench in California. And what that means is, statistically, 400 of them have anxiety or depression or both. I thought, somebody should speak about this in a way that starts to remove the stigma, that says this is just part of being in our culture, that anxiety and depression are real medical issues. People in all professions deal with these medical conditions: teachers, physicians, journalists, grocery clerks, whatever. I deal with them, and it does not disqualify me from being on the bench.
Q: Considering the political history and Thomas Eagleton's experience, did you hesitate, given the potential stakes?
I did take a moment to count the cost. The benefit of getting my story out in an effort to encourage others, inform families and friends, and work to destigmatize mental illness far outweighed any flak I might have faced in an election campaign.
Q: Do you employ other mental health strategies besides medication?
I exercise six days a week. I run and I lift weights and stay on top of that. Eating right. I had no caffeine for the five or six months that I was dealing with the worst of this, and I love coffee. I'm also very far along the spectrum toward introversion and need to have my alone time to recharge. So that is another tool that I use, especially when stressful things come up, which may mean that I say no to some things that I might normally say yes to.
Q: One thing that didn't change during all this was work. You continue to perform at a high level in a high-stress job, which is one of the things you write about.
Let's say an auto mechanic has a rotator cuff injury that becomes a chronic condition. This person needs to find a way to still do their job while accommodating the fact that one of their shoulders may not be as strong or limber as the other. Nobody goes to the mechanic and says, "You're disqualified from doing your job. Go home." Mental illness is the same. There are tons of ways to get the job done if you have anxiety or depression. It simply requires that same type of attention: This is my condition. This is my job. What do I need to be able to carry out my job that is appropriate? What it does not do is disqualify.
Medicare's annual open-enrollment season is here and millions of beneficiaries — prompted by a massive advertising campaign and aided by a detailed federal website — will choose a private Medicare Advantage plan.
But those who have instead opted for traditional Medicare face a critical decision about private insurance. Too often the import of that choice is not well communicated.
If beneficiaries decide to use traditional Medicare when they first join the program, they can pick a private supplemental plan — a Medigap plan — to help cover Medicare's sizable deductibles and copayments for hospital stays, physician visits and other services.
But many people don't realize that, in most states, beneficiaries have guaranteed access to a Medigap plan for only six months after they enroll in Medicare Part B — either at age 65 or when they leave private health insurance and join Part B.
While the Medicare.gov website offers a guide to these Medigap plans — labeled A through N — it's a complicated decision because each plan provides different kinds of coverage — for 10 categories of benefits. Then there are the variants with high deductibles and limited provider networks. Premiums vary sharply, of course. And because seniors enroll in these plans throughout the year as they reach Medicare eligibility, there is far less publicity about the options.
As long as a beneficiary pays the premiums, they cannot be disenrolled from a Medigap plan.Bottom of Form
For many who opted at some point for Medicare Advantage but decide later to move to traditional Medicare, getting a Medigap policy may be extremely difficult or impossible.
Lots of people making their plan choice this season may have missed their narrow window for Medigap enrollment. That means they may be stuck in Medicare Advantage or their current Medigap plan.
Ken Singer, 68, of Bridgewater, New Jersey, who retired from an investment management firm, didn't know about the limited opportunity to sign up for a Medigap policy. "Nobody told me that," he said. "I did a lot of reading about Medigap, but I found it kind of confusing." He wants a policy because he's leaving his wife's employer-based health plan.
"Not that many people aging into Medicare at 65 fully understand that moment may be their only opportunity to opt into Medigap," said Brian Connell, executive federal affairs director at the Leukemia and Lymphoma Society. "If you miss that short window, you're left without protection from high out-of-pocket costs."
While Medigap plans typically carry higher premiums than Medicare Advantage plans, the more expensive ones offer greater out-of-pocket cost protection.
After a beneficiary's initial six-month window, federal law does not prohibit Medigap insurers from rejecting applicants or charging a very high premium if they have a preexisting medical condition, unlike in the Affordable Care Act insurance market for people under 65. Only four states require insurers to offer Medigap coverage to applicants regardless of age or health. Medigap covers nearly 13 million beneficiaries.
In contrast, federal rules require Medicare Advantage plans to accept all applicants and charge the same premium regardless of their health. Out-of-pocket costs in Medicare Advantage plans are capped at $7,550 this year for in-network care, not counting prescription drugs. Traditional Medicare has no cost cap, but some of the Medigap plans cover the vast majority of those expenses that otherwise would be out-of-pocket.
At least partly because of these unequal consumer protections, 17% of the 33 million people in traditional Medicare have no supplemental insurance, according to Tricia Neuman, executive director for Medicare policy at KFF. Their out-of-pocket costs can reach tens of thousands of dollars a year for serious conditions like cancer or kidney disease.
Linda Ginsburg of Jacksonville, Florida, unknowingly missed her chance to buy a Medigap policy last year when she turned 65.
Because she has cancer, the retired medical office manager qualified for Medicare through Social Security Disability Insurance before turning 65, and she enrolled in a Medicare Advantage plan. She was paying a $385 monthly premium — $4,620 a year — and facing $7,000 a year in out-of-pocket costs, not counting her big prescription drug bills. So last year before her birthday, she called two insurance brokers about switching to traditional Medicare and getting a Medigap plan, which she thought would offer better, cheaper coverage. Medicare rules offer a Medigap open enrollment opportunity for disabled beneficiaries when they turn 65.
Both brokers told her, inaccurately, that she couldn't switch because she has cancer. "They said insurers aren't going to take you, you should stay where you are," Ginsburg recalled. "They absolutely were unaware that was a period when I could have gotten in without being asked about my cancer."
Now she's stuck — and angry. "I thought screening for preexisting conditions is against the law," she lamented. "But it's not true when you hit Medicare age."
Part of the confusion is due to states' very different rules governing Medigap policies. Connecticut, Maine, Massachusetts and New York require insurers to accept any applicant regardless of age or medical history, according to KFF.
In other states, people over 65 receive federally guaranteed access to a Medigap plan only under limited circumstances, such as if they move or switch out of a Medicare Advantage plan in their first year of Medicare. Twenty-eight states ensure people access to a Medigap plan if their employer terminates their retiree health benefits.
Then there are widely varying state rules for how Medigap insurers can price their plans. Eight states bar charging people more because they are older or sicker. The remaining states allow setting premiums based on age, meaning a Medigap policy may well be unaffordable for older seniors.
The situation is worse for the nearly 9 million beneficiaries younger than 65 who qualify for Medicare because of a long-term disability. Just 31 states require insurers to sell a Medigap policy to people in this group.
Members of a subgroup — kidney dialysis patients under 65 — have even more limited access to an affordable Medigap policy. Only 14 states mandate that insurers offer them affordable coverage. Starting last year, the federal government guaranteed them access to Medicare Advantage plans but not to a Medigap policy. But Medicare Advantage plans may not include the providers that dialysis patients need, said Holly Bode, vice president of government affairs at the American Kidney Fund.
Guaranteed access to an affordable Medigap policy is important, consumer advocates say, because beneficiaries who develop serious medical conditions disproportionately want to leave their Medicare Advantage plan for the broader choice of providers available through traditional Medicare.
A Government Accountability Office report in July urged Medicare officials to examine why beneficiaries in their last year of life switched from Medicare Advantage to traditional Medicare at more than twice the rate of other Medicare Advantage enrollees.
Some legislators are already pushing to revamp the Medigap market. The Close the Medigap Act, recently reintroduced by Rep. Lloyd Doggett (D-Texas), chair of the House Ways and Means Health Subcommittee, would ensure that beneficiaries with preexisting conditions could buy a Medigap policy anytime and wouldn't face higher premiums.
Another House bill, sponsored by Rep. Jaime Herrera Beutler (R-Wash.) and Rep. Cindy Axne (D-Iowa), would require Medigap insurers to offer the same plans to kidney dialysis patients under 65 that they offer to beneficiaries 65 and up.
Health insurers generally have opposed bills that require them to guarantee coverage or affordable pricing of Medigap plans, arguing that would raise premiums for current policyholders. AHIP (America's Health Insurance Plans), an industry lobbying group, has taken no position on these two bills.
Neither bill, however, is included in the Democrats' broad legislative package to expand health and social programs. In a written statement, Doggett expressed disappointment, saying that extending preexisting condition protections to the Medigap market is "one of the important pieces of unfinished business remaining from the Affordable Care Act."
When Martin Njoku saw opioid addiction devastate his West Virginia community, he felt compelled to help. This was the place he'd called home for three decades, where he'd raised his two girls and turned his dream of owning a pharmacy into reality.
In 2016, after flooding displaced people in nearby counties, Njoku began dispensing buprenorphine to them and to local customers at his Oak Hill Hometown Pharmacy in Fayette County.
Buprenorphine, a controlled substance sold under the brand names Subutex and Suboxone, is a medication to treat opioid use disorder. Research shows it halves the risk of overdose and doubles people's chances of entering long-term recovery.
"I thought I was doing what was righteous for people who have illness," Njoku said.
But a few years later, the Drug Enforcement Administration raided Njoku's pharmacy and accused the facility of contributing to the opioid epidemic rather than curbing it. The agency revoked the pharmacy's registration to dispense controlled substances, claiming it posed an "imminent danger to public health and safety." Although two judges separately ruled in Njoku's favor, the DEA's actions effectively shuttered his business.
"I lost everything that I worked for," Njoku said.
Lawyers, pharmacists, harm-reduction advocates and a former DEA employee say Njoku's case is emblematic of the DEA's aggressive stance on buprenorphine. An opioid itself, the medication can be misused, so the DEA works to limit its diversion to the streets. But many say the agency's policies are exacerbating the opioid epidemic by scaring pharmacies away from dispensing this medication when it's desperately needed.
Drug overdose deaths hit record highs last year, and despite medical experts considering medications like buprenorphine the gold standard, less than 20% of people with opioid use disorder typically receive them. The federal government has taken steps to increase the number of clinicians who prescribe buprenorphine, but many patients struggle to get those prescriptions filled. A recent study found that 1 in 5 U.S. pharmacies do not provide buprenorphine.
"Pharmacies are terrified they're going to lose their DEA registration and go out of business," said Charles "Buck" Selby, a former inspector and chief compliance officer for the West Virginia Board of Pharmacy, who retired in 2018.
The ramifications can be particularly acute in rural areas, where a dearth of addiction treatment providers, lack of transportation and stigma against these medications already create barriers. If pharmacies decline to provide buprenorphine too, patients will have few options left, Selby said.
The DEA did not respond to requests for comment.
Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who hand out prescriptions and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to misuse and typically has higher street value than Suboxone, a combination of buprenorphine and the overdose-reversal drug naloxone.
In the case against Njoku's pharmacy, an assistant U.S. attorney explained that the DEA "got slapped hard for being asleep at the switch as the opioid crisis ramped up. … They're trying to make sure that Subutex doesn't become the next problem," according to court transcripts.
Buprenorphine is less likely to cause overdoses than other opioids because its effects taper off at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based coalition Project Opioid.
In Njoku's case, the DEA said in court documents that several "red flags" had suggested the pharmacy's actions were irresponsible. First, many of the prescriptions it filled were for Subutex instead of Suboxone. Patients also traveled – sometimes out of state – to get prescriptions, drove long distances within West Virginia to reach Njoku's pharmacy, and often paid in cash.
In traditional prescription drug cases, these are all markers of trouble. But — as Njoku's lawyers argued and two judges later agreed — they can also reflect the difficulty of getting addiction treatment, which is sometimes more challenging than obtaining illicit drugs.
"The practical reality and context of West Virginia turn these additional flags from red to yellow," U.S. District Judge Joseph Goodwin wrote in his opinion. Patients may go out of their way for the drug because there aren't enough nearby doctors who prescribe it or pharmacies that stock it, he wrote. They might pay cash because they're uninsured or Medicaid won't cover prescriptions written by an out-of-network doctor. And they might prefer Subutex because it's often cheaper than Suboxone.
By 2020, Goodwin and an administrative law judge at the DEA had both ruled in Njoku's favor. But several insurers and drug suppliers had already stopped doing business with him. Njoku closed the pharmacy in April 2021.
Across the country, when a pharmacy stops providing buprenorphine, the ripple effects can be far-reaching.
Trish Mashburn works at two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, she began getting five calls a day from prospective customers trying to get their prescriptions filled, she said. Although both her employers stock buprenorphine, they order only a set amount, so Mashburn often must turn patients away.
Research in North Carolina and Kentucky has found that many pharmacists worry that ordering more buprenorphine will trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it requires wholesalers to flag suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed projected need.
They base these limits, in part, on the DEA's enforcement actions, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies and other clients on regulatory compliance. Since pharmacies are not typically privy to how these limits are set, many simply order small batches of buprenorphine out of caution.
That creates a "prescribing cliff," said Bayla Ostrach, lead author of a paper studying this issue in North Carolina. Doctors may prescribe buprenorphine to more patients, but pharmacies order enough for only a certain number of customers. Since many people stay on buprenorphine for years, once the pharmacy hits its self-established quota, it may rarely have openings for new patients.
A Lee County, Florida, man thought he was one of the lucky ones. James, 34, had been filling his Subutex prescription at the supermarket chain Publix for seven years. In that time, he held steady jobs and cared for his wife and children. (James asked KHN to withhold his last name so future employers wouldn't judge him on his addiction history.)
Then, last year, James said, he went to get his prescription refilled and was told Publix no longer stocks Subutex — the medication the DEA considered a "red flag" in Njoku's case.
Publix did not respond to requests for comment.
A decade ago, when James began the medication, he chose Subutex because it was cheaper than Suboxone. Today, most insurance plans cover Suboxone, and the price difference has narrowed somewhat.
James was not eager to change to a potentially pricier medication. And he worried a different drug might disrupt his recovery — a common sentiment among patients in long-term recovery, said Dr. Nathan Mullins, director of addiction medicine fellowship at Mountain Area Health Education Center in North Carolina. Changing their medication is unnecessary and can cause needless anxiety, Mullins said.
Luckily, James found an independent pharmacy that provides Subutex. It's more expensive, since the new place doesn't accept his insurance, he said. He pays about $40 a week, compared with $40 a month previously.
But James said it's worth it.
"I've been in 10 rehabs and a million detoxes, and the only thing that has worked for me was one sublingual tablet," James said. Along with therapy, "this saved my life."
In September, when Texas' near-total abortion ban took effect, Planned Parenthood clinics in the Lone Star State started offering every patient who walked in information on Senate Bill 8, as well as emergency contraception, condoms and two pregnancy tests. The plan is to distribute 22,000 "empowerment kits" this year.
"We felt it was very important for patients to have as many tools on hand to help them meet this really onerous law," said Elizabeth Cardwell, lead clinician at Planned Parenthood of Greater Texas, which has 24 clinics across the northern and central regions of the state and provides care to tens of thousands of people annually.
Most of their patients — who tend to be uninsured and have annual household incomes of less than $25,000 — had not known about SB 8 the first several weeks after implementation, said Cardwell. But once they learned about it, patients seemed to rush to get on birth control, she said.
SB 8 allows private citizens, in Texas or elsewhere, to sue anyone who performs an abortion in the state or who "aided or abetted" someone getting an abortion once fetal cardiac activity is detected. This is generally around six weeks, before most people know they're pregnant. It's had a chilling effect in Texas, where access to abortion was already limited.
Medical staffs are doubling down on educating patients about birth control. They recognize the strategy isn't foolproof but are desperate to prevent unintended pregnancies, nearly half of which nationwide end in abortion.
"It's more important now than it ever has been," said Cardwell. "I've been in abortion care 30-plus years, and my go-to line was 'You've got plenty of time. You don't have to feel rushed. Talk with your partner. Talk with your family,'" she said. "Now we don't have that luxury."
Patients, too, seem to feel a sense of urgency. During September, according to data from Planned Parenthood of Greater Texas, medical staff provided patients with some form of birth control — for example, pill packs, Depo-Provera shots or IUD implant insertions — in more than 3,750 visits, 5% more than in September 2020.
Dr. Jennifer Liedtke, a family physician in West Texas, said she and her nurse practitioners explain SB 8 to every patient who comes to their private practice and saw a 20% increase in requests for long-acting reversible contraceptive methods, known as LARCs, in September.
LARCs, a category that includes intrauterine devices and hormonal implants, have become increasingly appealing because they are 99% effective at preventing pregnancy and last several years. They are also simpler than the pill, which needs to be taken daily, or the vaginal ring, which needs to be changed monthly.
Still, LARCs are not everyone's preferred method. For example, inserting an IUD can be painful.
A doctor's office is one of the few opportunities for reliable birth control education. Texas law doesn't require schools to teach sex education, and if they do, educators must stress abstinence as the preferred birth control method. Some doctors opt to explain abortion access in the state when naming birth control options.
Liedtke is used to having to explain new laws passed by the Texas legislature. "It happens all the time," she said. But the controversy surrounding SB 8 confuses patients all the more as the law works its way through the court system with differing rulings, one of which briefly blocked the measure. The U.S. Supreme Court heard related arguments Nov. 1.
"People just don't understand," said Liedtke. "It was tied up for 48 hours, so they are like, 'It's not a law anymore?' Well, no, technically it is."
Not all providers are able to talk freely about abortion access. In 2019, the Trump administration barred providers that participate in the federally funded family planning program, Title X, from mentioning abortion care to patients, even if patients themselves raise questions. In early October, the Biden administration reversed that rule. The change will kick in this month. Planned Parenthood can discuss SB 8 in Texas because Texas affiliates do not receive Title X dollars.
Dr. Lindsey Vasquez of Legacy Community Health, the largest federally qualified health center in Texas and a recipient of Title X dollars, said she and other staff members have not discussed abortion or SB 8 because they also must juggle a variety of other priorities. Legacy's patients are underserved, she said. A majority live at or below the federal poverty level.
Nearly two years into the COVID-19 pandemic, "we're literally maximizing those visits," Vasquez said. Their jobs go beyond offering reproductive care. "We're making sure they have food resources, that they have their housing stable," she said. "We really are trying to make sure that all of their needs are met because we know for these types of populations — patients that we serve — this may be our only moment that we get to meet them."
Specialized family planning clinics that receive Title X dollars do have proactive conversations about contraceptive methods, according to Every Body Texas, the Title X grantee for the state.
Discussions of long-acting reversible contraception must be handled with sensitivity because these forms of birth control have a questionable history among certain populations, primarily lower-income patients. In the 1990s, lawmakers in several states, including Texas, introduced bills to offer cash assistance recipients financial incentives to get an implant or mandate insertion for people on government benefits, a move seen as reproductive coercion.
"It's important for a client to get on the contraceptive method of their choice," said Mimi Garcia, communications director for Every Body Texas. "Some people will just say, 'Let's get everyone on IUDs' or 'Let's get everybody on hormonal implants' because those are the most effective methods. … That's not something that's going to work for [every] individual. … Either they don't agree with it philosophically or they don't like how it makes their body feel."
It's a nuanced subject for providers to broach, so some suggest starting the conversation by asking the patient about their future.
"The best question to ask is 'When do you want to have another baby?'" said Liedtke. And then if they say, 'Oh, gosh, I'm not even sure I want to have more kids' or 'Five or six years from now,' then we start talking LARCs. … But if it's like, 'Man, I really want to start trying in a year,' then I don't talk to them about putting one of those in."
The Biden administration expected more demand for birth control in Texas, so Health and Human Services Secretary Xavier Becerra announced in mid-September that Every Body Texas would receive additional Title X funding, as would local providers experiencing an influx of clients as a result of SB 8.
But providers said improved access to contraception will not blunt the law's effects. It will not protect patients who want to get pregnant but ultimately decide on abortion because they receive a diagnosis of a serious complication, their relationship status changes, or they lose financial or social support, said Dr. Elissa Serapio, an OB-GYN in the Rio Grande Valley and a fellow with Physicians for Reproductive Health.
"It's the very best that we can do," said Cardwell, of Planned Parenthood of Greater Texas. "There's no 100% effective method of birth control."
When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.
The demands for access to the drug were loud and insistent, despite federal regulators' recent warning against using the drug to treat COVID.
Ivermectin is a generic drug that has been used for decades to treat river blindness, scabies and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.
At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn't discuss it.
"I went every bit as far as I could without getting myself thrown in jail trying to save my father's life," he told the panel, as lawmakers offered condolences.
"What is going on here?" he asked, with the passion in his voice growing. "My dad's dead!"
The pleas to public officials have been building. And now politicians are beginning to act, largely to satisfy their conservative constituents.
After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious "preprint" studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.
On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.
But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.
"If we have medications out here that are working — or seem to be working — I think it's absolutely horrible that we're not trying them," said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.
The doctors challenged the implied insult that they weren't following best practices: "Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession," said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.
Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.
Last year, Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he's not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.
Kory acknowledged his medical opinions have landed him on "an island."
He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.
By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.
Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He'd been giving it to "every patient with COVID," he said.
"After the pharma-geddon that was unleashed, yeah, they shut it down," he told the South Carolina lawmakers. "And I will tell you that many hospitals across the country had already shut it down months ago."
Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.
Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.
In an interview with NPR, Kory said he regrets the flashpoint he helped ignite.
"I feel really bad for the patients, and I feel really bad for the doctors," he told NPR. "Both of them — both the patients and doctors — are trapped."
Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.
Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.
The Montana State News Bureau reported that the state's Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.
In a statement, St. Peter's Hospital said doctors and nurses were "harassed and threatened by three public officials."
"These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC," the statement added.
On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the "off-label" use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.
Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.
Even as they gain powerful political supporters, some ivermectin fans say they're now avoiding the healthcare system — because they've lost faith in it.
Lesa Berry, of Richmond, Virginia, had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Berry and the patient's daughter.
They know better now, she said.
"My first attempt would have been to keep her out of the hospital," Berry said. "Because right now when you go to the hospital, they only give you what's on the CDC protocol."
Berry and her husband have purchased their own supply of ivermectin, which they keep at home.
Earlier this year, the World Health Organization announced a global campaign to combat ageism — discrimination against older adults that is pervasive and harmful but often unrecognized.
"We must change the narrative around age and ageing" and "adopt strategies to counter" ageist attitudes and behaviors, WHO concluded in a major report accompanying the campaign.
Several strategies WHO endorsed — educating people about ageism, fostering intergenerational contacts, and changing policies and laws to promote age equity — are being tried in the United States. But a greater sense of urgency is needed in light of the coronavirus pandemic's shocking death toll, including more than 500,000 older Americans, experts suggest.
"COVID hit us over the head with a two-by-four, [showing that] you can't keep doing the same thing over and over again and expect different results" for seniors, Jess Maurer, executive director of the Maine Council on Aging, said in an October webinar on ageism in healthcare sponsored by KHN and the John A. Hartford Foundation. "You have to address the root cause — and the root cause here is ageism."
Some experts believe there's a unique opportunity to confront this concern because of what the country has been through. Here are some examples of what's being done, particularly in healthcare settings.
Distinguishing old age from disease. In October, a group of experts from the U.S., Canada, India, Portugal, Switzerland and the United Kingdom called for old age to be removed as one of the causes and symptoms of disease in the 11th revision of the International Classification of Diseases, a global resource used to standardize health data worldwide.
Aging is a normal process, and equating old age with disease "is potentially detrimental," the experts wrote in The Lancet. Doing so could result in inadequate clinical evaluation and care and an increase in "societal marginalisation and discrimination" against older adults, they warn.
Identifying ageist beliefs and language. Groundbreaking research published in 2015 by the FrameWorks Institute, an organization that studies social issues, showed that many people associate aging with deterioration, dependency and decline — a stereotype that almost surely contributed to policies that harmed older adults during the pandemic. By contrast, experts understand that older adults vary widely in their abilities and that a significant number are healthy, independent and capable of contributing to society.
Using this and subsequent research, the Reframing Aging Initiative, an effort to advance cultural change, has been working to shift how people think and talk about aging, training organizations across the country. Instead of expressing fatalism about aging ("a silver tsunami that will swamp society"), it emphasizes ingenuity, as in "we can solve any problem if we resolve to do so," said Patricia D'Antonio, project director and vice president of policy and professional affairs at the Gerontological Society of America. Also, the initiative promotes justice as a value, as in "we should treat older adults as equals."
Since it began, the American Medical Association, the American Psychological Association and the Associated Press have adopted bias-free language around aging, and communities in Colorado, New Hampshire, Massachusetts, Connecticut, New York and Texas have signed on as partners.
Tackling ageism at the grassroots level. In Colorado, Changing the Narrative, a strategic awareness campaign, has hosted more than 300 workshops educating the public about ageist language, beliefs and practices in the past three years. Now, it's launching a campaign calling attention to ageism in healthcare, including a 15-minute video set to debut in November.
"Our goal is to teach people about the connections between ageism and poor health outcomes and to mobilize both older people and [health] professionals to advocate for better medical care," said Janine Vanderburg, director of Changing the Narrative.
Faced with the pandemic's horrific impact, the Maine Council on Aging earlier this year launched the Power in Aging Project, which is sponsoring a series of community conversations around ageism and asking organizations to take an "anti-ageism pledge."
The goal is to educate people about their own "age bias" — largely unconscious assumptions about aging — and help them understand "how age bias impacts everything around them," said Maurer. For those interested in assessing their own age bias, a test from Harvard University's Project Implicit is often recommended. (Sign in and choose the "age IAT" on the next page.)
Changing education for health professionals. Two years ago, Harvard Medical School began integrating education in geriatrics and palliative care throughout its curriculum, recognizing that it hadn't been doing enough to prepare future physicians to care for seniors. Despite the rapid growth of the older population, only 55% of U.S. medical schools required education in geriatrics in 2020, according to the latest data from the Association of American Medical Colleges.
Dr. Andrea Schwartz, an assistant professor of medicine, directs Harvard's effort, which teaches students about everything from the sites where older adults receive care (nursing homes, assisted living, home-based programs, community-based settings) to how to manage common geriatric syndromes such as falls and delirium. Also, students learn how to talk with older patients about what's most important to them and what they most want from their care.
Schwartz also chaired a committee of the academic programs in geriatrics that recently published updated minimum competencies in geriatrics that any medical school graduate should have.
Altering professional requirements. Dr. Sharon Inouye, also a professor of medicine at Harvard, suggests additional approaches that could push better care for older adults forward. When a physician seeks board certification in a specialty or doctors, nurses or pharmacists renew their licenses, they should be required to demonstrate training or competency in "the basics of geriatrics," she said. And far more clinical trials should include a representative range of older adults to build a better evidence base for their care.
Inouye, a geriatrician, was particularly horrified during the pandemic when doctors and nurses failed to recognize that seniors with COVID-19 were presenting in hospital emergency rooms with "atypical" symptoms such as loss of appetite and delirium. Such "atypical" presentations are common in older adults, but instead of receiving COVID tests or treatment, these older adults were sent back to nursing homes or community settings where they helped spread infections, she said.
Bringing in geriatrics expertise. If there's a silver lining to the pandemic, it's that medical professionals and health system leaders observed firsthand the problems that ensued and realized that older adults needed special consideration.
"Everything that we as geriatricians have been trying to tell our colleagues suddenly came into sharp focus," said Dr. Rosanne Leipzig, a professor of geriatrics at the Icahn School of Medicine at Mount Sinai in New York City.
Now, more Mount Sinai surgeons are asking geriatricians to help them manage older surgical patients, and orthopedic specialists are discussing establishing a similar program. "I think the value of geriatrics has gone up as institutions see how we care for complicated older adults and how that care improves outcomes," Leipzig said.
Building age-friendly health systems. "I believe we are at an inflection point," said Terry Fulmer, president of the John A. Hartford Foundation, which is supporting the development of age-friendly health systems with the American Hospital Association, the Catholic Health Association of the United States and the Institute for Healthcare Improvement. (The John A. Hartford Foundation is a funder of KHN.)
More than 2,500 health systems, hospitals, medical clinics and other healthcare providers have joined this movement, which sets four priorities ("the 4Ms") in caring for older adults: attending to their mobility, medications, mentation (cognition and mental health) and what matters most to them — the foundation for person-centered care.
Creating a standardized framework for improving care for seniors has helped healthcare providers and systems know how to proceed, even amid the enormous uncertainty of the past couple of years. "We thought [the pandemic] would slow us down, but what we found in most cases was the opposite — people could cling to the 4Ms to have a sense of mastery and accomplishment during a time of such chaos," Fulmer said.
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The Medicare prescription drug pricing plan Democrats unveiled this week is not nearly as ambitious as many lawmakers sought, but they and drug policy experts say the provisions crack open the door to reforms that could have dramatic effects.
Tamping down drug expenses has been a longtime rallying cry for consumers beset by rapidly rising prices. Although people in private plans had some protections, those on Medicare often did not. They had no out-of-pocket caps and frequently complained that federal law kept them from using drugmakers' coupons or other cost-cutting strategies.
A plan offered earlier this year by House Democrats — which included robust negotiation over drug prices in Medicare — was blocked by a handful of moderates who argued that the price curbs would stifle innovation. The legislation also was on a course to hit roadblocks among senators.
The moderates favored more limited negotiation over drugs only in Medicare Part B — those administered in doctors' offices and hospitals. Most people in Medicare get their drugs through Part D, which covers medicine dispensed at a pharmacy.
When it appeared that the bill to fund President Joe Biden's social agenda would move forward without a drug pricing proposal, the pressure built, intense negotiations were held, and a hybrid proposal was unveiled. It includes identifying 100 of the most expensive drugs and targeting 10 of them for negotiations to bring those costs down beginning in 2025. It will also place inflation caps on prescription drug prices for all insurance plans, restrict copays for insulin to no more than $35, and limit Medicare beneficiaries' annual out-of-pocket drug costs to $2,000.
"There was a sense that the government had its hands tied behind its back. Now a precedent is being set," said Senate Finance Committee Chairman Ron Wyden (D-Ore.), who led the talks for the senators. "There's going to be negotiation on the most expensive drugs: cancer drugs, arthritis drugs or the anticoagulants. And that's a precedent, and once you set a precedent that you can actually negotiate, you are really turning an important corner."
Drugmakers say the changes could stymie consumers' options. "Under the guise of 'negotiation,' it gives the government the power to dictate how much a medicine is worth," Stephen Ubl, CEO of the trade group PhRMA, said in a statement, "and leaves many patients facing a future with less access to medicines and fewer new treatments."
But how, exactly, will the changes be felt by most Americans, and who will be helped?
The answers vary, and many details would still have to be worked out by government agencies if the legislation passes. House members warned some minor changes were still being made Thursday night, and it all has to pass both chambers.
Controlling Insulin Costs
One of the most obvious benefits will go to those who need insulin, the lifesaving drug for people with Type 1 diabetes and some with Type 2 diabetes. Although the drug has been around for decades, prices have risen rapidly in recent years. Lawmakers have been galvanized by nightmarish accounts of people dying because they couldn't afford insulin or driving to Canada or Mexico to get it cheaper.
Under the bill, starting in 2023, the maximum out-of-pocket cost for a 30-day supply of insulin would be $35. The benefit would not be limited to Medicare beneficiaries.
That cap is the same as one that was set in a five-year model program in Medicare. In it, the Centers for Medicare & Medicaid Services estimated that the average patient would save about $466 a year.
Detailed analyses of the proposals were not yet available, so it is unclear what the fiscal impact or savings would be for patients outside of Medicare.
Limiting Out-of-Pocket Spending
Another obvious benefit for Medicare beneficiaries is the $2,000 cap on out-of-pocket costs for prescription drugs. Currently, drug costs for people in the Part D prescription drug plans are calculated with a complicated formula that features the infamous "doughnut hole," but there is no limit to how much they might spend.
That has led to consumers with serious diseases such as cancer or multiple sclerosis paying thousands of dollars to cover their medication, a recent KFF analysis found. Under current law, when an individual beneficiary and her plan spend $4,130 this year on drugs, the beneficiary enters the doughnut hole coverage gap and pays up to 25% of the price of the drug. Once she has spent $6,500 on drugs, she is responsible for 5% of the cost through the end of the year.
Limiting that expense is an especially big deal for people who get little low-income assistance and have expensive illnesses, said Dr. Jing Luo, an assistant professor of medicine at the University of Pittsburgh's Center for Research on Healthcare. "The patient pays 5% of all drug costs, and 5% of $160,000 is still a lot of money," he said.
The legislation would alleviate that fear for consumers. "Rather than having a bill at the end of the year, like over $10,000, maybe their bill at the end of that year for that very expensive multiple myeloma treatment is $2,000," he said.
Negotiating Drug Prices
Medicare price negotiation is probably the highest-profile provision in the legislation — and the most controversial. According to the bill, the Department of Health and Human Services would be responsible for identifying the 100 high-cost drugs and choosing the 10 for price negotiations. That effort wouldn't start until 2023, but the new prices would go into effect in 2025. Another 10 drugs could be added by 2028. No drugs have been identified yet.
To meet the concerns of some lawmakers, the legislation lays out specific provisions for how HHS would select the drugs to be included. Only drugs identified as one of a kind or the only remedy for a specific health problem would be included.
The list would also be limited to drugs that have been on the market beyond the period of exclusivity the government grants them to be free from competition and recoup costs. For most regular drugs, the exclusivity can last nine years. For the more complicated biologic drugs, the period would be 12 years. Using the exclusivity timing allowed lawmakers to skirt the issue of whether the drugs were still under patent protection.
The measure allows for prices to be negotiated to a lower level for older drugs chosen for the program. So, for example, the negotiated price for a non-biologic drug that has been available for less than 12 years would be 75% of the average manufacturer price. That would fall to 65% for drugs that are 12 to 16 years past their initial exclusivity, and 40% for drugs more than 16 years past the initial exclusivity.
Drugs from smaller companies with sales under $200 million are excluded because lawmakers were afraid tamping down their prices would harm innovation.
Some experts questioned whether the negotiated prices would be directly felt by consumers.
"It helps Medicare, without question, to reduce their expenditures," said William Comanor, a professor of health policy and management at the UCLA Fielding School of Public Health. "But how does that affect consumers? I bet Medicare doesn't change the copay."
Yet, he added, the copayment is less of an issue if a consumer's prescription expenses are capped at $2,000.
Linking Prices to Inflation
Under the bill, manufacturers would have to report their prices to the HHS secretary, and if the prices increase faster than inflation, the drugmakers would have to pay a rebate to the government. Manufacturers that don't pay the rebate would face a civil penalty of 125% of the value of the rebate.
The provisions would apply to drugs purchased through Medicare and non-Medicare plans.
Over the long term, the idea is to slow the overall inflation of drug prices, which has exceeded general inflation for decades.
Drug prices would be pegged to what they were in March, and the system would go into effect in 2023, so there would be little immediate impact. (Some lawmakers had hoped to peg the program to prices from several years ago — which might produce a bigger effect — but that was changed in the negotiations over the weekend.) The long-term impact is also hard to judge, because under the current complicated system, many people who pay for drugs get assistance from the drug companies, and most generics in the U.S. are relatively inexpensive, Comanor said.
Over the long haul, though, savings are expected to be substantial for the government, as well as for consumers who don't qualify for other programs to help pay drug expenses and need high-end medication.
At the very least, the legislation would move the U.S. in the direction of the rest of the world.
"The longer the drug is on the market, the lower the price," said Gerard Anderson, a professor of health policy at Johns Hopkins' medical school. "In every other country, the price goes down over time, while in the United States, it is common for prices to increase."
Democrats have little room for maneuvering on the bill. They need all 50 Democratic senators to support it and can lose only three members of the House on a vote.
This article was published on Friday, November 5, 2021 in Kaiser Health News.
President Joe Biden's mammoth domestic spending bill would add hearing benefits to the traditional Medicare program — one of three major new benefits Democrats had sought.
The Biden administration appears to have fallen short of its ambition to expand dental and vision along with hearing benefits. Sen. Bernie Sanders (I-Vt.) and other progressives have long pushed for more generous benefits for seniors. Citing the cost, Sen. Joe Manchin (D-W.Va.) opposed such expansion.
Biden and Democratic leaders in Congress pared back the scope of the new benefits after the total budget bill — which funds healthcare and other domestic initiatives — was whittled from a proposed $3.5 trillion to $1.75 trillion to meet demands of the party's moderates. The new hearing benefits would become available in 2023.
Democrats have little room for maneuvering on the bill. They need all 50 Democratic senators to support it and can lose only three members of the House on a vote. Those tight margins have made for difficult negotiations and boosted the ability of any one lawmaker to set terms. The progressive and moderate wings of the party have been at odds on the deal for months, and negotiations are ongoing.
Nonetheless, if the hearing proposal survives, it would be a significant change. Here are answers to questions seniors might have about the benefit.
Q: What does the plan do?
The draft legislation unveiled in the House proposes adding coverage to traditional Medicare that includes hearing assessment services, management of hearing loss and related treatment. About 36 million people are enrolled in original Medicare. Many of the private Medicare Advantage plans other seniors have opted to join already offer similar hearing services. According to the Centers for Medicare & Medicaid Services, roughly 27 million seniors are enrolled in a Medicare Advantage plan this year. CMS projects that number will increase to 29.5 million next year.
The new benefits include coverage of certain hearing aids for "individuals diagnosed with moderately severe, severe, or profound hearing loss," and allows seniors enrolled in traditional Medicare to get a hearing aid for each ear every five years. The new benefits cover devices furnished after a written order from a physician, audiologist, hearing aid professional or other clinician. The Food and Drug Administration separately has moved to make hearing aids available over the counter, in a bid to make them cheaper.
Q: Why are the benefits needed?
Research has shown that hearing loss can undermine seniors' overall quality of life, leading to loneliness, isolation, depression, anxiety, communication disorders and more. According to the Centers for Disease Control and Prevention's National Health Interview Survey, in 2019 nearly 1 in 3 people age 65 and over reported difficulty hearing even with a hearing aid. Biden administration officials said when unveiling the package last week that of seniors who could benefit from hearing aids, only 30% over age 70 have used them.
Hispanic adults 65 and up were more likely than other demographic groups to report having severe hearing problems, the survey found.
A KFF analysis from September found that the 4.6 million Medicare beneficiaries who used hearing services in 2018 paid $914 out-of-pocket on average. That figure includes seniors who receive benefits in traditional Medicare as well as people enrolled in Medicare Advantage plans.
Q: How many people would benefit?
The total is still up in the air as Democrats continue to negotiate details, but it's possible the number of beneficiaries could be in the millions. According to the National Institutes of Health, about 1 in 3 Americans ages 65 to 74 have hearing loss, and nearly half of those older than 75 have difficulty hearing.
To date, there's been an important distinction between seniors enrolled in traditional Medicare and those in Medicare Advantage plans. A research paper published by the Commonwealth Fund in February found that nearly all Medicare Advantage plans offered dental, vision and hearing benefits.
Still, even with Medicare Advantage, seniors can struggle to afford care, and what is covered varies by the plan. The KFF analysis found that seniors in Medicare Advantage plans spent less out-of-pocket for dental and vision care than traditional Medicare enrollees in 2018, but there was no difference in spending on hearing care.
Q: Will dental and vision benefits be added?
Leaving dental and vision benefits on the cutting room floor will disappoint progressive lawmakers.
"In Vermont and all over this country, you've got senior citizens whose teeth are rotting in their mouth, older people who can't talk to their grandchildren because they can't hear them because they can't afford a hearing aid, and people can't read a newspaper because they can't afford glasses," Sanders said on NBC earlier this year. "So to say that dental care and hearing aids and eyeglasses should be a part of Medicare makes all the sense in the world."
According to KFF, the 31.3 million Medicare beneficiaries who needed dental services in 2018 paid $874 out-of-pocket on average. The 20.3 million who needed vision care spent $230.
About 21% of the patients who contracted COVID in the hospital from April to September last year died. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.
This article was published on Thursday, November 4, 2021 in Kaiser Health News.
They went into hospitals with heart attacks, kidney failure or in a psychiatric crisis.
They left with COVID-19 — if they left at all.
More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.
Yet in the scheme of things that can go wrong in a hospital, it is catastrophic: About 21% of the patients who contracted COVID in the hospital from April to September last year died, the data shows. In contrast, nearly 8% of other Medicare patients died in the hospital at the time.
Steven Johnson, 66, was expecting to get an infection cut out of his hip flesh and bone at Blake Medical Center in Bradenton, Florida, last November. The retired pharmacist had survived colon cancer and was meticulous to avoid contracting COVID. He could not have known that, from April through September, 8% of that hospital's Medicare COVID patients were diagnosed with the virus after they were admitted for another concern.
Johnson had tested negative for COVID two days before he was admitted. After 13 days in the hospital, he tested positive, said his wife, Cindy Johnson, also a retired pharmacist.
Soon he was struggling to clear a glue-like phlegm from his lungs. A medical team could hardly control his pain. They prompted Cindy to share his final wishes. She asked: "Honey, do you want to be intubated?" He responded with an emphatic "no." He died three days later.
After her husband tested positive, Cindy Johnson, trained in contact tracing, quickly got a COVID test. She tested negative. Then she thought about the large number of hospital staffers flowing into and out of his room — where he was often unmasked — and suspected a staff member had infected him. That the hospital, part of the HCA Healthcare chain, still has not mandated staff vaccinations is "appalling," she said.
"I'm furious," she said.
"How can they say on their website," she asked, "that the safety precautions 'we've put into place make our facilities among the safest possible places to receive healthcare at this time'?"
Blake Medical Center spokesperson Lisa Kirkland said the hospital is "strongly encouraging vaccination" and noted that it follows Centers for Disease Control and Prevention and federal and state guidelines to protect patients. President Joe Biden has called for all hospital employees to be vaccinated, but the requirement could face resistance in a dozen states, including Florida, that have banned vaccine mandates.
Overall, the rate of in-hospital spread among Medicare and other patients was lower than in other countries, including the United Kingdom, which makes such data public and openly discusses it. On average, about 1.7% of U.S. hospitalized COVID patients were diagnosed with the virus in U.S. hospitals, according to an analysis of Medicare records from April 1 to Sept. 30, 2020, provided by Dr. James Kennedy, founder of CDIMD, a Nashville-based consulting and data analytics company.
Yet the rate of infection was far higher in 38 hospitals where 5% or more of the Medicare COVID cases were documented as hospital-acquired. The data is from a challenging stretch last year when protective gear was in short supply and tests were scarce or slow to produce results. The Medicare data for the fourth quarter of 2020 and this year isn't available yet, and the state data reflects April 1 through Dec. 31, 2020.
A KHN review of work-safety records, medical literature and interviews with staff at high-spread hospitals points to why the virus took hold: Hospital leaders were slow to appreciate its airborne nature, which made coughing patients hazardous to roommates and staff members, who often wore less-protective surgical masks instead of N95s. Hospitals failed to test every admitted patient, enabled by CDC guidance that leaves such testing to the "discretion of the facility." Management often failed to inform workers when they'd been exposed to COVID and so were at risk of spreading it themselves.
Spread among patients and staffers seemed to go hand in hand. At Beaumont Hospital, Taylor, in Michigan, 139 employee COVID infections were logged between April 6 to Oct. 20 last year, a hospital inspection report shows. Nearly 7% of the Medicare patients with COVID tested positive after they were admitted to that hospital for something else, the federal data shows. A hospital spokesperson said tests were not available to screen all patients last year, resulting in some late diagnoses. He said all incoming patients are tested now.
Tracking COVID inside health facilities is no new task to federal officials, who publicly report new staff and resident cases weekly for each U.S. nursing home. Yet the Department of Health and Human Services reports data on COVID's spread in hospitals only on a statewide basis, so patients are in the dark about which facilities have cases.
KHN commissioned analyses of hospital billing records, which are also used more broadly to spot various hospital-acquired infections. For COVID, the data has limitations. It can pick up some community-acquired cases that were slow to show up, as it can take two to 14 days from exposure to the virus for symptoms to appear, with the average being four to five days. The records do not account for cases picked up in an emergency room or diagnosed after a hospital patient was discharged.
Linda Moore, 71, tested positive at least 15 days into a hospital stay for spinal surgery, according to her daughter Trisha Tavolazzi. Her mother was at Havasu Regional Medical Center in Lake Havasu City, Arizona, which did not have a higher-than-average rate of internal spread last summer.
The hospital implemented "rigorous health and safety protocols to protect all of our patients" during the pandemic, said hospital spokesperson Corey Santoriello, who would not comment on Moore's case, citing privacy laws.
Moore was airlifted to another hospital, where her condition only declined further, her daughter said. After the ventilator was removed, she clung to life fitfully for 5½ hours, as her daughter prayed for her mother to find her way to heaven.
"I asked her mom and her dad and her family and prayed to God, 'Please just come show her the way,'" Tavolazzi said. "I relive it every day."
When Tavolazzi sought answers from the hospital about where her mom got the virus, she said, she got none: "No one ever called me back."
Two Negative COVID Tests, Then 'Patient Zero'
As the second surge of COVID subsided last September, doctors from the prestigious Brigham and Women's Hospital published a reassuring study: With careful infection control, only two of 697 COVID patients acquired the virus within the Boston hospital. That is about 0.3% of patients ― about six times lower than the overall Medicare rate. Brigham tested every patient it admitted, exceeding CDC recommendations. It was transparent and open about safety concerns.
But the study, published in the high-profile JAMA Network Open journal, conveyed the wrong message, according to Dr. Manoj Jain, an infectious-disease physician and adjunct professor at the Rollins School of Public Health at Emory University. COVID was spreading in hospitals, he said, and the study buried "the problem under the rug."
Before the virtual ink on the study was dry, the virus began a stealthy streak through the elite hospital. It slipped in with a patient who tested negative twice ― but turned out to be positive. She was "patient zero" in an outbreak affecting 38 staffers and 14 patients, according to a study in Annals of Internal Medicine initially published Feb. 9.
That study's authors sequenced the genome of the virus to confirm which cases were related ― and precisely how it traveled through the hospital.
As patients were moved from room to room in the early days of the outbreak, COVID spread among roommates 8 out of 9 times, likely through aerosol transmission, the study says. A survey of staff members revealed that those caring for coughing patients were more likely to get sick.
The virus also appeared to have breached the CDC-OK'd protective gear. Two staff members who had close patient contact while wearing a surgical mask and face shield still wound up infected. The findings suggested that more-protective N95 respirators could help safeguard staff.
Brigham and Women's now tests every patient upon admission and again soon after. Nurses are encouraged to test again if they see a subtle sign of COVID, said Dr. Erica Shenoy, associate chief of the Infection Control Unit at Massachusetts General Hospital, who helped craft policy at Brigham.
She said nurses and environmental services workers are at the table for policymaking: "I personally make it a point to say, 'Tell me what you're thinking,'" Shenoy said. "'There's no retribution because we need to know.'"
CDC guidelines, though, left wide latitude on protective gear and testing. To this day, Shenoy said, hospitals employ a wide range of policies.
The CDC said in a statement that its guidelines "provide a comprehensive and layered approach to preventing transmission of SARS-CoV-2 in healthcare settings," and include testing patients with "even mild symptoms" or recent exposure to someone with COVID.
Infection control policies are rarely apparent to patients or visitors, beyond whether they're asked to wear a mask. But reviews of public records and interviews with more than a dozen people show that at hospitals with high rates of COVID spread, staff members were often alarmed by the lack of safety practices.
Nurses Sound the Alarm on COVID Spread
As COVID crept into Florida in spring 2020, nurse Victoria Holland clashed with managers at Blake Medical Center in Bradenton, where Steven Johnson died.
She said managers suspended her early in the pandemic after taking part in a protest and "having a hissy fit" when she was denied a new N95 respirator before an "aerosol-generating" procedure. The CDC warns that such procedures can spread the virus through the air. Before the pandemic, nurses were trained to dispose of an N95 after each patient encounter.
When the suspension was over, Holland said, she felt unsafe. "They told us nothing," she said. "It was all a little whisper between the doctors. You had potential COVIDs and you'd get a little surgical mask because [they didn't] want to waste" an N95 unless they knew the patient was positive.
Holland said she quit in mid-April. Her nursing colleagues lodged a complaint with the Occupational Safety and Health Administration in late June alleging that staff "working around possible COVID-19 positive cases" had been denied PPE. Staff members protested outside the hospital in July and filed another OSHA complaint that said the hospital was allowing COVID-exposed employees to keep working.
Kirkland, the Blake spokesperson, said the hospital responded to OSHA and "no deficiencies were identified."
The Medicare analysis shows that 22 of 273 patients with COVID, or 8%, were diagnosed with the virus after they were admitted to Blake. That's about five times as high as the national average.
Kirkland said "there is no standard way for measuring COVID-19 hospital-associated transmissions" and "there is no evidence to suggest the risk of transmission at Blake Medical Center is different than what you would find at other hospitals."
In Washington, D.C., 34 Medicare COVID patients contracted the virus at MedStar Washington Hospital Center, or nearly 6% of its total, the analysis shows.
Unhappy with the safety practices ― which included gas sterilization and reuse of N95s — National Nurses United members protested on the hospital lawn in July 2020. At the protest, nurse Zoe Bendixen said one nurse had died of the virus and 50 had gotten sick: "[Nurses] can become a source for spreading the disease to other patients, co-workers and family members."
Nurse Yuhana Gidey said she caught COVID after treating a patient who turned out to be infected. Another nurse ― not managers doing contact tracing ― told her she'd been exposed, she said.
Nurse Kimberly Walsh said in an interview there was an outbreak in a geriatric unit where she worked in September 2020. She said management blamed nurses for bringing the virus into the unit. But Walsh pointed to another problem: The hospital wasn't COVID-testing patients coming in from nursing homes, where spread was rampant last year.
MedStar declined a request for an interview about its infection control practices and did not respond to specific questions.
While hospitals must track and publicly report rates of persistent infections like C. diff, antibiotic-resistant staph and surgical site infections, similar hospital-acquired COVID rates are not reported.
KHN examined a different source of data that Congress required hospitals to document about "hospital-acquired conditions." The Medicare data, which notes whether each COVID case was "present on admission" or not, becomes available months after a hospitalization in obscure files that require a data-use agreement typically granted to researchers. KHN counted cases, as federal officials do, in some instances in which the documentation is deemed insufficient to categorize a case (see data methodology, below).
For this data, whether to deem a COVID case hospital-acquired lies with medical coders who review doctors' notes and discharge summaries and ask doctors questions if the status is unclear, said Sue Bowman, senior director of coding policy and compliance at American Health Information Management Association.
She said medical coders are aware that the data is used for hospital quality measures and would be careful to review the contract tracing or other information in the medical record.
If a case was in the data KHN used, "that would mean it was acquired during the hospital stay either from a healthcare worker or another patient or maybe if a hospital allowed visitors, from a visitor," Bowman said. "That would be a fair interpretation of the data."
The high death rate for those diagnosed with COVID during a hospital stay — about 21% — mirrors the death rate for other Medicare COVID patients last year, when doctors had few proven methods to help patients. It also highlights the hazard unvaccinated staffers pose to patients, said Jain, the infectious-disease doctor. The American Hospital Association estimates that about 42% of U.S. hospitals have mandated that all staff members be vaccinated.
"We don't need [unvaccinated staff] to be a threat to patients," Jain said. "[Hospital] administration is too afraid to push the nursing staff, and the general public is clueless at what a threat a non-vaccinated person poses to a vulnerable population."
Cindy Johnson said the hospital where she believes her husband contracted COVID faced minimal scrutiny in a state inspection, even after she said she reported that he caught COVID there. She explored suing, but an attorney told her it would be nearly impossible to win such a case. A 2021 state law requires proof of "at least gross negligence" to prevail in court.
Johnson did ask a doctor who sees patients at the hospital for this: Please take down the big "OPEN & SAFE" sign outside.
Within days, the sign was gone.
KHN Midwest correspondent Lauren Weber contributed to this report.
Methodology
KHN requested custom analyses of Medicare, California and Florida inpatient hospital data to examine the number of COVID-19 cases diagnosed after a patient's admission.
The Medicare and Medicare Advantage data, which includes patients who are mostly 65 or older, is from the Medicare Provider Analysis and Review (MedPAR) file and was analyzed by CDIMD, a Nashville-based medical code consulting and data analytics firm. The data is from April 1 through Sept. 30, 2020. The data for the fourth quarter of 2020 is not yet available.
That data shows the number of inpatient Medicare hospital stays in the U.S., including the number of people diagnosed with COVID and the number of admissions for which the COVID diagnosis was not "present on admission." A condition not "present on admission" is presumed to be hospital-acquired. The data is for general acute-care hospitals, which may include a psychiatric floor, and not for other hospitals such as Veterans Affairs or stand-alone psychiatric hospitals.
KHN requested a similar analysis from California's Department of Healthcare Access and Information of its hospital inpatient data. That data was from April 1 through Dec. 31, 2020, and covered patients of all ages and payer types and in general, private psychiatric and long-term acute-care hospitals. Etienne Pracht, a University of South Florida researcher, provided the number of Florida COVID patients who did not have the virus upon hospital admission for all ages at general and psychiatric hospitals from April 1 through Dec. 31, 2020. KHN subtracted the number of Medicare patients in the MedPAR data from the Florida and California all-payer datasets so they would not be counted twice.
To calculate the rate of Medicare patients who got COVID or died, KHN relied on the MedPAR data for April through September. That data includes records for 6,629 seniors, 1,409 of whom, or 21%, died. California data for all ages and payer types from April through December shows a similar rate: Of 2,115 who contracted COVID after hospital admission, 435, or 21%, died. The MedPAR data was also used to calculate the national nosocomial COVID rate of 1.7%, with 6,629 of 394,939 COVID patients diagnosed with the virus that was deemed not present on admission.
Data on whether an inpatient hospital diagnosis was present on admission is used by Medicare for payment determinations and is intended to incentivize hospitals to prevent infections acquired during hospital care. It is also used by the U.S. Agency for Healthcare Research and Quality to "assist in identifying quality of care issues."
Whether COVID is acquired in a hospital or in the community is measured in different ways. Some nations assume the virus is hospital-acquired if it is diagnosed seven or more days after admission, while statewide U.S. data counts cases only after 14 days.
Medical coders who examine medical records for this inpatient billing data focus on the physician's admission, progress and discharge notes to determine whether COVID was present on admission. They do not have a set number of days they look for and are trained to query physicians if the case is unclear, according to Sue Bowman, senior director of coding policy and compliance at the American Health Information Management Association.
KHN tallied the cases in which COVID was logged in the data as not "present on admission" to the hospital. Some COVID cases are coded as "U" for having insufficient documentation to make a determination. Since Medicare and AHRQ consider the "U" to be an "N" (or not present on admission) for the purposes of payment decisions and quality indicators, KHN chose to count those cases in the grand total.
In 409 of 6,629 Medicare cases and in 70 of 2,185 California cases, the "present on admission" indicator was "U." The Florida data did not include patients whose "present on admission" indicator was "U." Medical coders have another code, "W," for "clinically undetermined" cases, which consider a condition present on admission for billing or quality measures. Medical coders use the "U" (leaning toward "not present on admission") and "W" (leaning toward "present on admission") when there is some uncertainty about the case.
The Medicare MedPAR data includes about 2,500 U.S. hospitals that had at least a dozen COVID cases from April through September 2020. Of those, 1,070 reported no cases of hospital-acquired COVID in the Medicare records. Data was suppressed for privacy reasons for about 1,300 hospitals that had between one and 11 hospital-acquired COVID cases. There were 126 hospitals reporting 12 or more cases of COVID that were not present on admission or unknown. For those, we divided the number of hospital-acquired cases by the total number of patients with COVID to arrive at the rate of hospital-acquired cases, as is standard in healthcare.
Trendy-looking websites promise convenience and freedom from networks, at far less than the cost of traditional health insurance.
"Welcome to insurance that's finally fair," says one, in bold lettering. "Take care of your health with one easy app," says another.
It's all part of shopping for health coverage in 2021.
While they're still niche products, these nontraditional options say they aim to soothe consumer frustration with high premiums and deductibles by harnessing the growing availability of price information or patients' newfound comfort with online health services.
One such offering, from insurer Sidecar Health, pays consumers its estimated cash price for each medical visit and lets them shop for the best deal. Another, from Antidote Health, isn't insurance, but offers access to online-only primary care for a small monthly fee.
Still, these plans come with a dose of "buyer beware."
While the image the plans present is one of consumers taking control of their health care costs, the "reality is likely the opposite," said Dania Palanker, assistant research professor at the Center on Health Insurance Reforms at Georgetown University.
That's because they are not Affordable Care Act plans. They are not comprehensive medical insurance, and could leave patients responsible for hundreds or even thousands of dollars, either because benefits cover only part of a medical bill or because of other plan limitations.
What's offered by California-based Sidecar Health and Antidote in New York may appeal to shoppers who are younger or more tech-savvy, the uninsured, or those who don't get subsidies to help them purchase Affordable Care Act plans.
Consumers say ACA plans are "too expensive, or the out-of-pocket costs are too high," or doctors don't accept them, said Mike Smith, president of The Brokerage, a marketing organization in Texas that recruits insurance agents and also sells insurance.
But these plans' lower premiums are possible, in part, because the plans cover less than ACA plans.
Standard benefits do not include maternity care, there's no annual limit on how much patients can pay out-of-pocket, and some decline to enroll people with health conditions, none of which is allowed in an ACA plan. Sidecar customers may find the amounts they receive to pay for care are less than they are charged, while Antidote doesn't cover lab work, X-rays, hospital care or expensive drugs.
Sidecar's Access Plan, licensed for sale in 17 states, adds a layer of pricing information to what's known as fixed-indemnity plans. Such plans pay the policyholder a flat rate, usually a dollar amount, based on the type of care they receive, such as a doctor visit or a day in the hospital.
Unlike typical indemnity plans, Sidecar provides more information, including individual payment calculations for 170,000 services based on its estimates of the average cash price in the patient's area for each service. That encompasses most services associated with regular doctor visits and lab work as well as the line-item charges included in surgeon's fees and hospital care.
But the medical provider might not accept that amount as full payment.
Patients can learn upfront from Sidecar the amount it will pay toward a medical visit — if they know what they need — and then shop around. Patients pay any difference between the Sidecar allowance and the actual charge. Conversely, if the patient can get it for less than Sidecar's rate, the enrollee pockets the difference.
CEO Patrick Quigley sees his company as part of a nascent effort to harness the growing availability of price information, one that may prompt reluctant Americans to comparison shop.
"We're building a product around transparency and control, turning patients into purchasers," he said.
Some policy experts caution that the plan falls far short of comprehensive coverage.
Indemnity insurance can be useful in filling coverage gaps, but "it isn't major medical health insurance," Palanker said.
Consumers must choose a coverage amount for the year, from as little as $5,000 to $2 million. If a person selects, say, $50,000 but faces a $100,000 hospital bill after a car accident or a bad case of COVID-19, they are responsible for the difference.
Because they're based partly on the total annual amount of coverage, premiums vary, but most are $200 to $300 a month, according to Sidecar.
Candidates must answer a series of health questions when applying, and those who weigh more than 300 pounds or have any of 13 specific health conditions are declined.
Quigley says the structure — no network, upfront price information — frees people to go to any doctor, hospital or clinic.
But it also means all services are out of network and there's no guarantee a provider or facility will accept the Sidecar benchmark price as payment in full.
"If the providers you need to see do not fall in line with the median amount paid in your area, you are on the hook," said Joshua Brooker, a principal at PA Health Advocates, an independent brokerage that operates in 11 states. It does not sell Sidecar.
For complex treatments, like surgery, Sidecar directs members to request ahead of time a detailed estimate with all the expected charges, then send it to Sidecar for a calculation of what it would pay.
"Consumers are not used to saying, 'I need every code you are going to bill,'" said Stacey Pogue, senior policy analyst with Every Texan, a policy and research group in Austin. "For a really sophisticated consumer who understands indemnity insurance and cash prices and negotiating, this could be a good product, but I just don't think there are that many such consumers."
There's also no way to shop around in an emergency.
In those cases, Sidecar says, it steps in after the fact and negotiates directly with the hospital, aiming for "a reasonable charge," Quigley said.
Even proponents, including The Brokerage's Smith, said Sidecar may not be the best choice for everyone. Clients who choose it must educate themselves on how it works, especially its limitations, he said.
Consumers buy Sidecar's Access Plan online from the company or through participating brokers like Smith, not through federal or state marketplaces offering ACA insurance, because it isn't major medical coverage.
That may soon change, at least in Ohio.
Sidecar Health said it has state approval to sell an ACA plan there, starting in November for coverage next year.
Because this version must meet all the law's requirements — including accepting applicants with preexisting health conditions, posing no dollar limits on how much care it will cover and capping enrollees' out-of-pocket costs — its premiums in some cases may be higher than the Access Plan's.
Unlike ACA offerings from other carriers, it will have no set network of doctors and hospitals. Consumers will shop around, armed with plan price information.
Antidote, meanwhile, is sold in eight states. Monthly membership fees start at $35 for an individual or $59 for a family.
Co-founder Ben Enosh initially described Antidote's fees as premiums but later corrected himself to say the program has "one monthly fee at a significantly lower price point than insurance, which requires a premium plus deductibles and copays."
And it describes itself as a "digital healthcare company," not insurance, providing technical and administrative support to physicians. That's why, he said, it is not licensed by insurance regulators in several states where it is sold.
The plan resembles "direct primary care," for which patients pay a monthly fee to their local doctor, who then provides all their primary care. Unlike most of these programs, which include in-person office visits, Antidote is all online, the patient may not see the same doctor every time, and the physician may well be in another state.
Antidote has a network of 50 online doctors, some of whom are investors, Enosh said. Before an online visit, patients answer a health questionnaire, which takes about 10 minutes, he added. Analyzed by an algorithm, that data then helps physicians decide what might be going on. The technology has helped shorten online visit time to an average of six minutes, he said.
There are definite coverage limits.
Antidote's service provides primary care visits only, although Enosh said it informs enrollees of cash prices available at nearby labs. The plan's terms of use online show doctor visits are limited to 12 a year for individuals and 20 for families, after which a fee of $15 per visit applies.
Hospitalization, imaging tests and surgery are not covered.
Additionally, its "no extra fee" drug coverage includes only 80 types of medications, which may well take care of run-of-the-mill concerns but not cancer or other major conditions. Patients would need to pay for those themselves.