Opinion: I Write About America's Absurd Healthcare System. Then I Got Caught Up in It.

KFF Health News, January 25, 2022

A pharmacist in St. Louis said my new employer-provided insurance wouldn't cover insulin without something called a prior authorization.

This article was published on Tuesday, January 25, 2022 in Kaiser Health News.

By Bram Sable-Smith  

I got a hurried voicemail from my pharmacist in Wisconsin the day before Thanksgiving letting me know my insurance was refusing to cover my insulin.  

I had enough of the hormone that keeps me alive to last 17 days.

In my 10 years living with Type 1 diabetes, I've never really struggled to access insulin. But in my job reporting on the people left behind by our country's absurdly complex healthcare system, I've written about how insulin's steep cost leads to deadly rationing and about patients protesting to bring those prices down.

For the most part, though, I've been spared from the problems I cover. Maybe that's why I waited over a week to call my new pharmacy in St. Louis, where I recently moved for this job with KHN.

I'd been waiting since September for an appointment with an endocrinologist in St. Louis; the doctor's office couldn't get me in until Dec. 23 and wouldn't handle my prescriptions before then. When I finally called a pharmacy to sort this out, a pharmacist in St. Louis said my new employer-provided insurance wouldn't cover insulin without something called a prior authorization. I've written about these, too. They're essentially requirements that a physician get approval from an insurance company before prescribing a treatment.

Doctors hate them. The American Medical Association has a website outlining proposed changes to the practice, while the insurance industry defends it as protecting patient safety and saving money. It feels like a lot of paperwork to confirm something we already know: Without insulin, I will die.

I knew right away the prior authorization would be a problem. Since it was a Saturday when I learned about the need for the authorization, my best option was to call my old endocrinologist's practice that Monday morning and beg his staffers to fill out forms for their now former patient.

I had enough insulin to last seven days.

But late that afternoon, I got an automated message from the pharmacy about an insurance issue.

After spending 45 minutes on hold the next morning, I finally got through to the pharmacist, who said my insurer was still waiting for a completed prior authorization form from my physician. I called the doctor's office to give a nudge.

Four days' worth of insulin left.

The price of my prescription without insurance was $339 per vial of insulin, and I use about two vials per month. Normally, I pay a $25 copay. Without the prior authorization, though, I'm exposed to the list price of insulin, as is anyone with diabetes who lacks insurance, even if they live in one of the states with copay caps intended to rein in costs.

I called the pharmacy again on Thursday at 7:30 p.m., figuring it'd be less busy. I got right through to the pharmacist, who told me my insurer was still waiting on the prior authorization form. Friday morning, the diabetes nurse at my doctor's office said she'd check on it and call me back.

I'd be out of insulin the next day.

By this time, I was live-tweeting my attempt to refill my prescription and started to get the kind of messages that are familiar to anyone in what's known as the "diabetes online community." People in Missouri offered me their surplus insulin. Some suggested I go to Walmart for $25 insulin, an older type I have no idea how to safely use.

My new strategy was to use one of the programs that insulin manufacturers started recently to help people get cheaper insulin. The very same day, the U.S. House Committee on Oversight and Reform's Democrats released a report deriding these types of assistance programs as "tools to garner positive public relations, increase sales, and raise revenue."

But before I tried that option, I heard back from the nurse who had called the pharmacy (she had spent 25 minutes on hold) and learned that my new insurance wouldn't cover the brand of insulin I was using. The pharmacist was checking on a different brand.

Soon the pharmacist called: My insurance would cover the other brand. But the pharmacy might not have enough to fill my order. She said I should call a different branch of the chain. The first location I called was also out but pointed me to another one that had it.

With 12 hours' worth of insulin left, I walked out of that third store with my medicine in hand.

It took 17 days and 20 phone calls. But I know I'm lucky. My insurance really is exceptional, recent events aside. My boss insisted that being alive was part of my job as I spent hours on the phone during the workday. And my job is to be persistent as I puzzle through the labyrinth of U.S. healthcare.

The time wasted by me, the pharmacists, the nurses and probably some insurance functionaries is astounding and likely both a cause and a symptom of the high cost of medical care. The problem is also much bigger than that.

Insulin is the single most important resource in my life, and this is what I had to do to get it. But I know not everyone has my good fortune. I've interviewed the loved ones of people with Type 1 diabetes who could not get insulin, and it's not hard to imagine how my story could have ended just as tragically.

On Dec. 23, I finally saw my new doctor, who sent in a new prescription. That night, I got a message that my insurer was waiting on a prior authorization.

I had 17 days' worth of insulin left.

Bram Sable-Smith: brams@kff.org, @besables

Why Medicare Doesn't Pay for Rapid At-Home COVID Tests

KFF Health News, January 24, 2022

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration's new rule doesn't apply to them.

This article was published on Monday, January 24, 2022 in Kaiser Health News.

By Michelle Andrews

What group is especially vulnerable to the ravages of COVID-19 even if fully vaccinated and boosted? Seniors. And who will have an especially tough time getting free at-home COVID tests under the Biden administration's plan? Yes, seniors.

As of Jan. 15, private insurers will cover the cost of eight at-home rapid COVID tests each month for their members — for as long as the public health emergency lasts.

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration's new rule doesn't apply to them.

It turns out that the laws governing traditional Medicare don't provide for coverage of self-administered diagnostic tests, which is precisely what the rapid antigen tests are and why they are an important tool for containing the pandemic.

"While at this time original Medicare cannot pay for at-home tests, testing remains a critical tool to help mitigate the spread of COVID," a statement from the federal Centers for Medicare & Medicaid Services said. Medicaid and CHIP cover at-home COVID tests, with no cost to beneficiaries, based on a 2021 Biden administration mandate.

Medicare patients are left to seek free tests other ways, including through the administration's new website, COVIDtests.gov, and at community centers. The Medicare program does cover rapid antigen or PCR testing done by a lab without charging beneficiaries, but there's a hitch: It's limited to one test per year unless someone has a doctor's order.

More needs to be done, advocates say.

The administration has changed some Medicare rules during the pandemic, including improving access to telehealth services and nursing home care, said David Lipschutz, associate director and senior policy attorney at the Center for Medicare Advocacy.

"We know that the Medicare program has significant flexibility relative to the public health emergency, and it has demonstrated it has the ability to alter the rules," Lipschutz said. "We think they should find the flexibility to offer the COVID at-home tests for free."

Q: Why can't the Medicare program reimburse beneficiaries for the over-the-counter tests or pick up the tab at the pharmacy as commercial health plans will do?

The services the Medicare program pays for are spelled out in federal law.

"It generally excludes over-the-counter things," said Casey Schwarz, senior counsel for education and federal policy at the Medicare Rights Center, an advocacy group. 

The public health emergency was recently extended 90 days, through mid-April, and the administration could yet decide to expand coverage. Some lawmakers in Congress are reportedly urging the administration to cover the tests.

It may not be a simple change, as these tests appear to fall into coverage gaps. Medicare Part A covers hospitalization, and Part B generally covers provider-based services like doctor visits and lab tests. Part D covers drugs.

"So there's a little bit of a question of where this type of benefit would fit," Schwarz said.

People in private plans sometimes pay upfront for services and then are reimbursed by their health plan. But that's not how Medicare works. The program pays providers, not beneficiaries. So that's another wrinkle that would have to be ironed out.

Q: So how can a Medicare beneficiary get free at-home COVID tests?

There are a couple of options. This week, the Biden administration launched a website, COVIDtests.gov, where anyone, including Medicare beneficiaries, can order free at-home COVID tests. One billion tests eventually will be available. Each residence initially can receive four tests.

Four tests is a far cry from the eight monthly tests that people with private insurance can be reimbursed for. But it's better than nothing, experts say, especially when preventing the spread of COVID requires repeated testing over a period of days.

"Four tests is not a lot of tests," said Juliette Cubanski, deputy director of the program on Medicare policy at KFF. "This is one of the most at-risk populations, and to not have the opportunity to buy at-home tests and get reimbursed puts this whole population on their back foot."

The Biden administration is also providing up to 50 million additional free at-home tests to community health centers and Medicare-certified health clinics.

But 50 million tests won't even provide one test apiece to the 62 million Medicare beneficiaries, Lipschutz said.

About 4 in 10 Medicare beneficiaries are in Medicare Advantage managed-care plans. These private plans may offer free at-home tests to members, but it's not required. Enrollees should check with their plans to see whether that's an option.

Q: What other free COVID testing options are available to Medicare beneficiaries?

In traditional Medicare, beneficiaries can get rapid antigen or PCR diagnostic tests without paying anything out-of-pocket if the test is ordered by a doctor or other healthcare provider and performed by a lab.

The federal government has set up more than 10,000 free pharmacy testing sites across the country that Medicare beneficiaries can visit as well.

With the recent extension of the public health emergency, the situation is fluid, and Medicare beneficiaries may yet get coverage for at-home COVID tests that's comparable to what privately insured people now have.

"This is all a moving target," Lipschutz said.

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

Vaccine Wars Ignite in California as Lawmakers Seek Stronger Laws

KFF Health News, January 24, 2022

Vaccine opponents say Democratic-led efforts to adopt stricter vaccine requirements are only helping propel their movement, handing them unparalleled momentum to build their ranks both in California and nationally.

This article was published on Monday, January 24, 2022 in Kaiser Health News.

By Angela Hart

SACRAMENTO — California is poised to become the front line of America's vaccination wars.

State lawmakers are drafting the toughest COVID-19 vaccine legislation in the country, backed by a new pro-vaccine lobbying force promising to counter anti-vaccine activists who have threatened government officials and shut down public meetings across the state. Legislators want to require most Californians to get the shots — not just schoolchildren and healthcare workers — and eliminate the exemptions that would allow many people to get out of them.

But vaccine opponents say Democratic-led efforts to adopt stricter vaccine requirements are only helping propel their movement, handing them unparalleled momentum to build their ranks both in California and nationally.

Vaccine opponents are focusing their ire on Democratic state Sen. Richard Pan of Sacramento, a pediatrician and the driving force behind three state vaccination laws passed since 2012. Prompted by outbreaks of pertussis and measles, the laws make it harder for schoolchildren to get out of childhood vaccinations.

"We have to be willing to take a stand," said Pan, who is developing legislation to crack down on COVID vaccine exemptions. "We need to be able to respond to this pandemic and future pandemics, but there is this asymmetrical warfare going on right now, and we're seeing the anti-vaccine movement trafficking in misinformation, threats, and violence."

The coming fight in California foreshadows looming vaccine battles across the country. President Joe Biden and Democratic governors are pressing vaccination as the most crucial public health measure for combating the coronavirus pandemic — while some prominent Republican governors cast doubt on the safety and value of vaccines, inciting anti-vaccination activists.

In California, the ultimate decision on toughening state vaccination laws will fall to Democratic Gov. Gavin Newsom, who is facing reelection in November after defeating a recall attempt last year.

Newsom has played to both sides recently. He has pushed tough vaccine mandates for groups such as healthcare workers, children, and teachers. But in nearly every pandemic-related press conference since October and on national TV, he has also reassured the public that they can receive medical, religious, and personal belief exemptions from his mandates.

"He's trying to be comforting and non-confrontational, but it sends a message that if you don't want to get the vaccine, don't get it," said Catherine Flores Martin, executive director of the California Immunization Coalition. "Gov. Newsom struggles with this — he's trying to have it both ways."

Pushing Mandates 'Aggressively'

Anti-vaccine demonstrations dominated Sacramento during California's last big vaccination fight, in 2019. In weekly rallies outside the Capitol, hundreds of activists railed against lawmakers, toting a portrait of Pan's face splattered in red. They shouted down lawmakers in legislative hearings and at one point hurled menstrual blood at state senators.

The fight that year was over Pan's bill to crack down on bogus medical exemptions for common childhood vaccinations against measles, polio, and other infectious diseases, which are required to attend in-person public and private school in California. Four years earlier, he spearheaded a law to ban personal belief exemptions for childhood vaccines.

But under state law, personal belief exemptions must be allowed for any newly required childhood vaccine unless the legislature passes a new law banning them.

Newsom issued a directive in October 2021 adding COVID vaccines to the list of required childhood immunizations — once federal officials fully authorize them for children. But because the legislature has not yet acted, Californians will be able to opt out by claiming the vaccines violate personal beliefs.

Pan and other Democratic lawmakers want to close that loophole this year, and potentially eliminate religious exemptions that healthcare workers can claim. They're also considering requiring a broad swath of Californians to get COVID vaccines to participate in much of daily life.

Lawmakers are still hashing out details but are expected to propose legislation requiring COVID vaccines for people to be in workplaces, schools, and public venues like malls, museums, and restaurants — without allowing them to avoid the shots through exemptions. Pan, who is leaving the legislature after this year because of term limits, may also push legislation to hold tech companies more accountable for spreading misinformation on social media platforms.

"Do you have the right to be safe at school? Do people deserve to be safe at work? Are businesses responsible for creating an environment that won't injure or harm you? This has to be part of the conversation," said Pan, who was shoved by a protester near the Capitol in 2019.

Last year, Buffy Wicks, a Democratic Assembly member from Oakland, and Evan Low, a Democratic Assembly member from Campbell, tried but failed to muscle through legislation establishing COVID vaccine mandates for workers and businesses. But the ongoing challenges of the pandemic have "reenergized" Democratic lawmakers this year, said state Sen. Scott Wiener (D-San Francisco), who is carrying legislation to lower the age at which someone can consent to a vaccine without parental permission from 18 to 12.

"It's important that we continue to push for vaccine mandates the most aggressively we possibly can," said Wicks, who faced death threats over her vaccine legislation last year. "We can't let ourselves be held hostage by these right-wing conspiracy theorists who are perpetrating hate and violence."

'The Firestorm Is Here'

Anti-vaccine activists acknowledge they may not succeed at defeating new legislation but welcome state lawmakers' attempts to impose stricter rules — they argue it helps them build a larger movement in California, on social media, and in other states.

"What they don't realize is the point of these rallies and protests is to bring more people into the fold, from all around the country," said Stefanie Fetzer, a chief organizer of the 2019 anti-vaccination demonstrations at the state Capitol. "Senator Pan galvanized a larger anti-vax movement that wouldn't have happened without him."

Scientists and health officials blame California's stagnating COVID vaccination rate largely on the anti-vaccine movement, which is peddling misinformation and lies. The share of Californians who are considered fully vaccinated is 69%, and booster shots are lagging — even though the state and local governments have plowed tens of millions of dollars into vaccination campaigns.

"What you see now is this movement being taken over by Republicans and this libertarian right-wing notion of individual rights and 'get government off my back.' They're believing and spreading this misinformation even though it's disproven," said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia. "Trying to stop it is like trying to stop Niagara Falls."

Vaccine opponents have also shut down government meetings and lobbed violent threats at officials backing mandates.

The Los Angeles Unified School District delayed its student vaccine mandate after anti-vaccine demonstrations, in an effort to keep unvaccinated students from dropping out. In Stockton and elsewhere, vaccine opponents have shouted down proposed school vaccine mandates.

Joshua Coleman, who organized hundreds of protesters in 2019 under his group V Is for Vaccine, has held rallies in Sacramento this year, again targeting Pan with a 10-foot poster and his image smeared in red.

"There will be constant pressure," Coleman said. "This is happening more and more all over the country, but we are building a movement out of California. Being forced to take a vaccine in order to participate in society is absolutely totalitarian."

Vaccine supporters realize they must fight back and are launching a lobbying campaign, led by political heavyweights from Sacramento and Washington, D.C., to combat vaccine opponents with some of their own tactics.

"The firestorm is here. This is ground warfare that the anti-vax extremists are bringing, and I think we need to be able to match it," said Crystal Strait, the former president and CEO of Planned Parenthood Affiliates of California who is leading the campaign under the group ProtectUS.

Campaign leaders are organizing students, parents, and pro-vaccine activists to counter anti-vaccination demonstrators in cities and counties across California and to debunk misinformation while giving state lawmakers political cover to enact tougher laws.

"We need to draw a really bold, bright line and let these extremists know that we will not be silent," Strait said.

The campaign emerged quietly last year, sponsoring a new law to limit protests outside vaccination clinics — which has since been blocked in court — and will launch ground-game political efforts this year.

"The science is on our side, and there's a silent majority on our side, but we're being drowned out in public forums where these decisions are being made," said Rose Kapolczynski, a longtime political consultant to former U.S. Sen. Barbara Boxer, who is working on the campaign. "We're going to activate the pro-vaccine majority when policies are being considered at the state and local levels."

Whither Newsom?

Newsom is also wading into the fray.

His administration has plowed $145 million into a campaign to increase COVID vaccinations and fight misinformation, in part by monitoring social media posts and flagging vaccine myths to social media companies. The administration is also developing a pro-vaccine counternarrative based on the misinformation.

"We want to be proactive about what the truth is and put it out there while debunking misinformation," said Dr. Mark Ghaly, secretary of the state's Health and Human Services Agency.

More than half a dozen public health experts interviewed for this story said that vaccine mandates work and that Newsom can boost the state's faltering vaccination rates by eliminating exemptions.

But since Newsom announced the COVID vaccine mandate for schoolchildren, he has publicly promoted exemptions.

"The mandate we put in place for the state of California includes personal exemptions," Newsom said during an appearance on "Good Morning America" in December. "There's plenty of latitude for families to make decisions."

Newsom has declined to say whether he would support legislation banning exemptions but said he'd work with lawmakers. "We can discuss the merits and demerits" of allowing exemptions, Newsom said this month. "We did what we felt was appropriate."

Barbara Ferrer, the public health director for Los Angeles County, which has recorded nearly 28,000 COVID deaths, more than a third of the state's total, called on Newsom and state lawmakers to adopt mandates without exemptions.

"If you allow that, you may as well not have a vaccine mandate," she said. "If you don't want your child to get vaccinated, then your child doesn't have to go to school. And you don't have to go to a restaurant. I'm not trying to be mean to people. I'm just saying there are some things you shouldn't be able to do if you're not vaccinated."

Angela Hart: ahart@kff.org, @ahartreports

The Doctor Didn't Show Up, but the Hospital ER Still Charged $1,012

KFF Health News, January 24, 2022

Many patients don't understand that they can rack up huge bills almost as soon as they walk through the doors of an ER.

This article was published on Monday, January 24, 2022 in Kaiser Health News.

By Noam N. Levey

Dhaval Bhatt had been warned about hospital emergency rooms.

"People always told me to avoid the ER in America unless you are really dying," said Bhatt, an immigrant from India who got a Ph.D. in pharmacology in the U.S. and is now a research scientist at Washington University in St. Louis.

But when Bhatt's 2-year-old son burned his hand on the kitchen stove on a Wednesday morning in April, the family's pediatrician directed them the next day to the local children's hospital.

Bhatt was traveling. So, his wife, Mansi Bhatt, took their son to the hospital and was sent to the emergency room. A nurse took the toddler's vitals and looked at the wound. She said a surgeon would inspect it more closely.

When the surgeon didn't appear after more than an hour, Bhatt's wife took her son home. The hospital told her to make a follow-up appointment with a doctor, which turned out to be unnecessary because the burn healed quickly.

Then the bill came.

The Patient: Martand Bhatt, a toddler covered by a UnitedHealthcare insurance plan provided by the employer of his father, Dhaval Bhatt.

Medical Service: An emergency room visit for a burn sustained when Martand touched an electric stove.

Total Bill: $1,012. UnitedHealthcare's negotiated rate was $858.92, all of which the Bhatts were responsible for because their plan had a $3,000 deductible.

Service Provider: SSM Health Cardinal Glennon Children's Hospital, one of 23 hospitals owned by SSM Health, a Catholic, nonprofit health system with more than $8 billion in annual revenue.

What Gives: Many patients don't understand that they can rack up huge bills almost as soon as they walk through the doors of an ER.

Unlike a restaurant or a mechanic who won't charge if someone gets tired of waiting for a table or an inspection of a rattling engine, hospital emergency rooms almost invariably charge patients as soon as they check in.

And once they register, patients will be billed — often a lot — whether treatment was rendered or not.

Martand Bhatt received almost no medical service. A nurse practitioner looked over the toddler, listened to his heart and stomach, and looked in his nose, mouth and ears, according to provider notes prepared by the hospital and shared with KHN by Bhatt.

The nurse didn't change the dressing on the wound or order any testing.

"My objection to this is that there was no care provided," Bhatt wrote to Bill of the Month.

"My wife did not drive for 45 minutes to get to an ER and wait for an additional 1½ hours for someone to tell me that our child's vitals — weight, height, temperature and blood pressure — were OK," Bhatt continued. "We already knew that. … It is absolutely ridiculous and unethical."

When the Bhatts left the emergency room, Martand was "alert, active and well-appearing," according to the notes.

The nurse's assessment of Martand cost $192, which was discounted by UnitedHealthcare to a negotiated rate of $38.92. The bulk of the Bhatts' bill — $820 — was something called a facility fee.

Hospital officials defend these fees as necessary to keep the emergency room open 24 hours a day as a community asset.

SSM Health spokesperson Stephanie Zoller Mueller declined to discuss the details of Martand's medical condition even though the Bhatts gave their permission for the hospital to do so.

In an email, Zoller Mueller said the charges were "appropriate" based on the "acuity of condition, discharge instructions, vital sign monitoring, traumatic wound care (and) numerous assessments."

She added: "A patient does not have to receive additional treatment — procedure, labs, x-rays, etc. — to validate an ED [emergency department] level charge."

But some patient advocates say these facility fees are applied much too widely and should be limited to patients who actually receive medical care.

"It's just not appropriate for someone to be charged if they're not provided treatment," said Adam Fox, deputy director of the Colorado Consumer Health Initiative. "Patients aren't availing themselves of a facility if they don't get care."

At the very least, hospitals could communicate more clearly to patients about the fees they may be charged for coming to an emergency room, said Maureen Hensley-Quinn, senior program director at the National Academy for State Health Policy.

"People should know that when they walk in to receive care, there is this fee that they will be assessed," Hensley-Quinn said.

Hospitals could also post at the entrance to the ER standard fees for different levels of emergency care.

Bhatt's fee still could have been lower if the hospital had classified his son's injury as minor. But, again, the hospital billing process worked against the family … and in favor of the hospital's bottom line.

Emergency visits are usually classified for billing on a scale from 1 to 5. Level 1 is minor and routine; Level 5 requires complex care for life-threatening conditions. And hospitals are increasingly using the highest-severity codes to classify emergency visits, research shows.

"There are financial incentives for billing at a higher severity," said Aditi Sen, who directs policy and research at the nonprofit Healthcare Cost Institute, which has studied emergency room coding.

Despite the lack of severity of Martand's wound and the absence of medical care, his visit was classified as Level 3, a moderate severity problem.

Resolution: Incensed that he'd been charged so much, Bhatt made numerous attempts to get the hospital to reduce the charges. He also appealed to UnitedHealthcare to review the charges.

His efforts failed. In August, Bhatt received a letter from an SSM Health "patient advocate" informing him that the hospital would not adjust the bill and instructing him to contact patient billing to arrange for payment.

While Bhatt was trying to reach the patient advocate by phone, his bill was sent to Medicredit, a collection agency, which began sending him notices and calling him.

After KHN contacted SSM Health, Bhatt received a call from someone who worked on "patient financial experience" issues at the hospital.

The hospital agreed to forgive the $820 facility fee. Bhatt agreed to pay the remaining $38.92, the professional fee for the ER nurse's work. Bhatt also received a notice from Medicredit that it would take no further action against him.

The Takeaway: The Bhatts did what most parents would do when a pediatrician advises them to take their child to the hospital.

But emergency rooms are among the most expensive places to get care in the U.S. health system.

If you have a relatively low-level issue, think twice before even registering at the front desk, the act that initiates the billing process. If your doctor doesn't have same-day appointments or after-hours service, think about urgent care, which is often much cheaper if the center isn't attached to a hospital.

And remember that if you go to a hospital emergency room with a relatively minor issue, chances are that you'll have to wait, as the Bhatts did. Patients with more serious problems will be seen first.

Once you're taken past the front desk, you will almost certainly be hit with a substantial facility fee even if you don't receive care.

Appealing that fee to the hospital can occasionally be successful, but there are no guarantees. And, as Bhatt learned, don't expect the health insurer to offer much help. Most insurers won't challenge how a medical visit is coded except on extremely expensive medical claims that will cost them money.

In this case, Bhatt was on the hook for the whole fee because he had a high-deductible plan, so the insurer had little incentive to take up his cause.

For now, patients' best hope, many advocates believe, is to publicize the high prices that hospitals charge for their services, inside and outside the emergency room.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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Noam N. Levey: nlevey@kff.org, @NoamLevey

Patient, Beware: Some States Still Pushing Ineffective COVID Antibody Treatments

KFF Health News, January 21, 2022

Use of the newly ineffective treatments produced by Regeneron Pharmaceuticals and Eli Lilly and Co. is highest in a dozen states.

This article was published on Friday, January 21, 2022 in Kaiser Health News.

By JoNel Aleccia

As the omicron variant completes its sweep across the U.S., states with scarce supplies of monoclonal antibody therapies continue to use two treatments that federal health officials warn no longer work against the highly contagious version of the virus that causes COVID-19. The antibody treatment now most recommended is sotrovimab from GlaxoSmithKline and Vir Biotechnology, and it's in short supply.

Use of the newly ineffective treatments produced by Regeneron Pharmaceuticals and Eli Lilly and Co. is highest in a dozen states. They include several Southern states with some of the nation's lowest vaccination rates, but also California, which ranks in the nation's top 20 for fully vaccinated residents, a KHN analysis of federal data shows. Many hospitals and clinics are still infusing the costly treatments — often charging hundreds of dollars a session — that public health officials now say are almost certainly useless.

That's because of the near-total dominance of omicron, which accounted for 99.5% of new COVID infections in the U.S. during the week that ended Jan. 15, according to the Centers for Disease Control and Prevention.

That point was underscored this week by updated guidelines from the National Institutes of Health that now recommend sotrovimab as the primary monoclonal treatment for the disease.

Unless providers are certain they are still treating patients infected with the delta variant, they shouldn't use the others, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy, who is also a former commissioner of the FDA and former administrator of CMS. And the delta variant is increasingly rare, accounting for 3% of cases in Louisiana, 7% in California, and 10% in Ohio, as examples.

"There's not a medical justification based on the evidence on the Regeneron and Lilly products," McClellan said.

Determining which patients are infected with the delta vs. omicron variant is complicated, said Dr. Christian Ramers, chief of population health and an infectious disease specialist at Family Health Centers of San Diego.

His clinic is one of the few sites in the nation using laboratory screening of positive PCR COVID tests that can tell whether patients are infected with delta vs. omicron — and then treating them accordingly. "Otherwise, you're giving this false sense of security to a patient that they're getting treatment," Ramers said. "I don't think it is ethical, and it goes against the principle of doing no harm."

Overall, U.S. hospitals used about 72,000 doses of the Regeneron and Lilly monoclonal antibody therapies from Jan. 5 through Jan. 18, according to the latest figures from the Department of Health and Human Services. Data regarding hospital-level use of sotrovimab, which became available more recently than the other products, is not yet available on the HHS site.

By comparison, hospitals used about 153,000 courses of the Regeneron and Lilly treatments from Dec. 22 through Jan. 4. They used about 169,000 courses from Aug. 26 through Sept. 8, near the height of the delta surge.

On Jan. 19, hospitals still had about 295,000 doses of the Regeneron and Lilly treatments on hand.

Nationwide, the federal government is distributing more than 50,000 courses of sotrovimab per week, though it remains in short supply. The Biden administration has agreed to buy about 1 million doses, including about 600,000 promised by March, GSK officials said.

Respectively, Michigan, Florida, Indiana, Missouri, Louisiana, California, Oklahoma, Kansas, Georgia, Ohio, New York, and Mississippi used the most courses of the Regeneron and Lilly treatments from Jan. 5 through Jan. 18, KHN's analysis showed.

In Florida, which used more than 5,200 courses of the outdated treatments during that two-week period, Republican Gov. Ron DeSantis has said he is not convinced that the Regeneron and Lilly products don't work against omicron. In Florida, omicron accounted for 97% of cases as of Jan. 20; delta accounted for 3%.

"We have had practitioners give both of those to people with omicron who said the symptoms got resolved," he said in a Jan. 5 speech provided by his spokesperson, Christina Pushaw.

Federal health officials managing allocation of the monoclonal antibody therapies paused shipments of the Regeneron and Lilly treatments on Dec. 23, after laboratory tests showed they were less effective against the surging omicron variant than the delta variant. But the Biden administration resumed shipments on Dec. 31, after complaints from DeSantis and some doctors that those therapies could still help people in places where the delta variant persisted.

Regeneron itself has said its antibody treatments are ineffective against the omicron variant. It contains more than 30 mutations in the virus's spike protein, which makes the variant better at dodging the monoclonal antibody treatments.

"It's really not justified at this point unless there's some other underlying secondary gain, political pressure, or perhaps the providers are truly not in touch with the reality of the variant proportions," Ramers said.

Earlier this month, HHS officials indicated that shipments of the three monoclonal antibody treatments would continue through Jan. 31, despite the growing proportion of omicron cases. A department spokesperson on background said the agency would continue to assess "any impacts to COVID-19's therapeutic allocations."

Monoclonal antibody treatments are lab-based molecules that mimic the body's immune response to infection. They are most often given through IV infusion, though some can be delivered with an injection. The federal government has agreed to purchase millions of doses of the Regeneron and Lilly products at a cost of about $2,100 per dose. The medicines are free to consumers, though hospitals and clinics do charge fees for administering the drugs and monitoring patients during the process.

Other treatments expected to be effective against omicron in high-risk, non-hospitalized patients include AstraZeneca's Evusheld, a long-acting injectable monoclonal antibody for immunocompromised people, and a three-day infusion of Gilead Sciences' remdesivir, which is approved by the FDA. New oral antiviral pills also are expected to be effective, although they, too, remain in short supply.

Providers in several states that have continued to use the Regeneron and Lilly products have offered varied reasons. Some said they believed delta infections continued to circulate locally; others said they felt desperate to try something.

Officials in Michigan, which used more than 5,800 doses of the Regeneron and Lilly products during the most recent two weeks, and California, which used more than 3,400, have allowed healthcare providers to use their clinical judgment about which treatment to prescribe.

But in Mississippi, where omicron is rampant and fewer than half of residents have been fully vaccinated, state health officer Dr. Thomas Dobbs called for an end to the use of the treatments.

"We will be recommending that clinicians and physicians do not use these products right now based on the distribution of omicron vs. delta," he said during a recent press conference.

At Ramers' clinic in San Diego, care providers have been dispensing scarce doses of the monoclonal antibody treatments only when they're confident they'll help. That has meant sending batches of positive PCR tests to a laboratory in nearby Irvine, where they are screened to see whether one of three target genes is not detected, a known marker for an omicron infection.

Patients infected with the delta variant were able to be treated with REGEN-COV, the Regeneron product, preserving sotrovimab for the growing number of omicron cases, said Pauline Lucatero, the clinic's director of nursing.

"Looking into my patients' eyes and seeing fear, just fear, all I could tell them is we believe this treatment works and we're going to do everything we can to save as many people as we can," she said.

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Wildfires and Omicron Prompt a Special Health Insurance Enrollment Period in Colorado

KFF Health News, January 20, 2022

The move underscores how much industry attitudes toward the Affordable Care Act have changed.

This article was published on Thursday, January 20, 2022 in Kaiser Health News.

By Markian Hawryluk

A wildfire displaced thousands of Coloradans just as the omicron surge began sweeping through the state, so health insurance was likely not on many people's minds when the regular enrollment period for the state's health insurance marketplace ended Jan. 15. But now, because of those twin emergencies, everyone in the state will get another chance to sign up.

State officials on Wednesday launched a special marketplace enrollment period, through March 16, open to all uninsured Coloradans regardless of whether they've been directly affected by the fire or the COVID-19 surge.

The Marshall Fire started on Dec. 30, just two weeks before the deadline to sign up for a 2022 plan. The fire destroyed more than 1,000 houses and businesses, quickly becoming the state's most destructive fire by number of structures lost. 

"It's such a disruption to people's lives," Colorado Insurance Commissioner Michael Conway said. "It's not just the people who lost their homes — it's across the board, affecting the entire community."

Meanwhile, the emergence of the omicron variant of the coronavirus caused COVID cases to spike to record levels in January, stressing hospitals and health systems.

"These folks are just trying to put their lives back together," said Kevin Patterson, CEO of Connect for Health Colorado, the state's health insurance marketplace, created under the Affordable Care Act. "So giving them some additional time seemed like a reasonable and thoughtful thing to consider."

In addition to providing immediate relief to Coloradans in a crisis, the move underscores how much industry attitudes toward the Affordable Care Act have changed. Insurance companies were initially skeptical about the financial risks and worried that consumers would game the system. But the insurers have largely embraced the exchanges and are working to sign up as many people as possible. After experiencing few problems during the special enrollment period held last year because of COVID, health plans have agreed to the removal of safeguards — such as a limited window of time to sign up for coverage — that regulators once required.

"Amid the recent COVID-19 surge and tragic wildfires, it is important that people in Colorado have the opportunity to obtain healthcare coverage," Patrick Gordon, CEO of the Rocky Mountain Health Plans, said in an email.

Special enrollment periods have been used in California because of wildfires, in Maine when strong winds knocked down power lines, and in Gulf states hit by Hurricanes Harvey, Irma, and Maria. 

Such periods have often been limited in scope and sometimes required people to provide proof they had been affected.

Colorado state officials are taking a different route. They opted to make signing up for coverage as easy as possible and are not requiring consumers to demonstrate they qualify.

"It didn't seem like something that was necessary, especially when we look at our experience over the last year," Conway said. "The vast majority of the year was effectively a special enrollment period, and there wasn't that much disruption in the market."

Insurance analyst Charles Gaba said there are three primary reasons for limiting health plan sign-ups to an open enrollment period.

The first is that deadlines spur people to sign up. Each year, enrollment numbers spike in the final days of the sign-up period. 

Second, insurance companies need time to analyze their revenue and costs to set premiums for the following year. That process, Gaba said, typically begins in March. 

Third, and most importantly, insurance companies initially lobbied for a limited open enrollment period to keep people from waiting until they are sick to buy insurance. That changed during the pandemic. Colorado and most other states that run their own exchanges held special enrollment periods in 2020 and 2021 because of COVID. When the Trump administration declined to do the same for the federal exchange, health insurance trade groups urged it to reconsider. The incoming Biden administration agreed and extended the enrollment period through August 2021 — and more than 2.8 million additional Americans signed up for coverage.

Conway said no evidence exists that consumers waited until they were sick to buy coverage last year. With so many consumers eligible for no-cost or low-cost plans because of more generous subsidies, there is little reason for them not to sign up immediately.

"As health policy folks, sometimes we get into our heads and we see monsters under the bed that simply are not there because of the complexity of the system," Conway said.

Health plans in Colorado were largely supportive of the move. John Roble, president of Cigna's Mountain States market, said the company is allowing early prescription refills and is working with local hospitals to transfer patients to help alleviate crowding at overwhelmed facilities.

Past special enrollment periods largely attracted a healthier population than standard open enrollment periods. Those with chronic health conditions, who face the potential of high medical bills, usually enroll early in the standard open enrollment period. 

"They are first out of the gate," said Louise Norris, who operates a Colorado health insurance brokerage with her husband. "They're ready to sign up Nov. 1."

The procrastinators are those generally less concerned about their health and more apt to leave things to the last minute, she said. The added time will also help people who chose to go without insurance but then experience a significant medical problem after the standard open enrollment period closes, she said.

State officials said new health concerns stemming from the fires and the omicron surge may also make health coverage more important for some Coloradans.

Consumers benefit when more people, particularly more healthy people, enroll. "The more people that get covered, the more stable the overall risk pool is, the more stable the premiums are for consumers," said Adam Fox, deputy director of the Colorado Consumer Health Initiative, a nonprofit consumer advocacy group. "All of those things help people stay covered."

States that run their own exchanges often extend the deadline for signing up another week or two to give late-comers extra time. But it's not clear whether any other states will follow Colorado's example and provide a two-month or longer window in response to the omicron surge.

"Without the fires, I'm not sure that they would be thinking about it," Conway said.

Markian Hawryluk: MarkianH@kff.org, @MarkianHawryluk

5 Things You Should Know About 'Free' At-Home COVID Tests

KFF Health News, January 19, 2022

You can either get a test without any out-of-pocket expense from retail pharmacies that are part of an insurance company's network or buy it at any store and get reimbursed by the insurer.

This article was published on Wednesday, January 19, 2022 in Kaiser Health News.

By Damon Darlin  

Americans keep hearing that it is important to test frequently for COVID-19 at home. But just try to find an "at-home" rapid COVID test in a store and at a price that makes frequent tests affordable.

Testing, as well as mask-wearing, is an important measure if the country ever hopes to beat COVID, restore normal routines and get the economy running efficiently. To get Americans cheaper tests, the federal government now plans to have insurance companies pay for them.

The Biden administration announced Jan. 10 that every person with private insurance can get full coverage for eight rapid tests a month. You can either get one without any out-of-pocket expense from retail pharmacies that are part of an insurance company's network or buy it at any store and get reimbursed by the insurer.

Congress said private insurers must cover all COVID testing and any associated medical services when it passed the Families First Coronavirus Response Act and the Coronavirus Aid, Relief and Economic Security, or CARES, Act. The have-insurance-pay-for-it solution has been used frequently through the pandemic. Insurance companies have been told to pay for PCR tests, COVID treatments and the administration of vaccines. (Taxpayers are paying for the cost of the vaccines themselves.) It appears to be an elegant solution for a politician because it looks free and isn't using taxpayer money.

1. Are the tests really free?

Well, no. As many an economist will tell you, there ain't no such thing as a free lunch. Someone has to pick up the tab. Initially, the insurance companies bear the cost. Cynthia Cox, a vice president at KFF who studies the Affordable Care Act and private insurers, said the total bill could amount to billions of dollars. Exactly how much depends on "how easy it is to get them, and how many will be reimbursed," she said.

2. Will the insurance company just swallow those imposed costs?

If companies draw from the time-tested insurance giants' playbook, they'll pass along those costs to customers. "This will put upward pressure on premiums," said Emily Gee, vice president and coordinator for health policy at the Center for American Progress.

Major insurance companies like Cigna, Anthem, UnitedHealthcare and Aetna did not respond to requests to discuss this issue.

3. If that's the case, why haven't I been hit with higher premiums already?

Insurance companies had the chance last year to raise premiums but, mostly, they did not.

Why? Perhaps because insurers have so far made so much money during the pandemic they didn't need to. For example, the industry's profits in 2020 increased 41% to $31 billion from $22 billion, according to the National Association of Insurance Commissioners. The NAIC said the industry has continued its "tremendous growth trend" that started before COVID emerged. Companies will be reporting 2021 results soon.

The reason behind these profits is clear. You were paying premiums based on projections your insurance company made about how much healthcare consumers would use that year. Because people stayed home, had fewer accidents, postponed surgeries and, often, avoided going to visit the doctor or the hospital, insurers paid out less. They rebated some of their earnings back to customers, but they pocketed a lot more.

As the companies' actuaries work on predicting 2023 expenditures, premiums could go up if they foresee more claims and expenses. Paying for millions of rapid tests is something they would include in their calculations.

4. Regardless of my premiums, will the tests cost me money directly?

It's quite possible. If your insurance company doesn't have an arrangement with a retailer where you can simply pick up your allotted tests, you'll have to pay for them — at whatever price the store sets. If that's the case, you'll need to fill out a form to request a reimbursement from the insurance company. How many times have you lost receipts or just plain neglected to mail in for rebates on something you bought? A lot, right?

Here's another thing: The reimbursement is set at $12 per test. If you pay $30 for a test — and that is not unheard of — your insurer is only on the hook for $12. You eat the $18.

And by the way, people on Medicare will have to pay for their tests themselves. People who get their healthcare covered by Medicaid can obtain free test kits at community centers.

A few free tests are supposed to arrive at every American home via the U.S. Postal Service. And the Biden administration has activated a website where Americans can order free tests from a cache of a billion the federal government ordered.

5. Will this help bring down the costs of at-home tests and make them easier to find?

The free COVID tests are unlikely to have much immediate impact on general cost and availability. You will still need to search for them. The federal measures likely will stimulate the demand for tests, which in the short term may make them harder to find.

But the demand, and some government guarantees to manufacturers, may induce test makers to make more of them faster. The increased competition and supply theoretically could bring down the price. There is certainly room for prices to decline since the wholesale cost of the test is between $5 and $7, analysts estimate. "It's a big step in the right direction," Gee said.

HHS Proposal for Marketplace Plans Carries a Hefty Dose of Consumer Caution

KFF Health News, January 19, 2022

A consumer's first hint that something is wrong is a big one: a letter from the IRS or a delay in their tax refund.

This article was published on Wednesday, January 19, 2022 in Kaiser Health News.

By Julie Appleby  

Some insurance brokers are enrolling people into Affordable Care Act health plans without their consent, perhaps for the commissions, a move that could put consumers in danger of owing back the subsidies connected with the coverage. The damage could be hundreds or even thousands of dollars.

A consumer's first hint that something is wrong is a big one: a letter from the IRS or a delay in their tax refund.

Although the practice does not appear widespread, it has prompted the Department of Health and Human Services to seek changes to some oversight rules affecting brokers. They would start in 2023.

HHS wants the changes, according to its proposal, because it "has observed several instances in which agents, brokers, and web-brokers have provided inaccurate consumer household income projections" and that "this is problematic in situations when consumers are enrolled without their knowledge or consent."

The changes are part of a 400-page proposed rule governing the federal health insurance marketplace and a few states that use the federal platform for their own exchanges. The new broker provision aims to deter fraudulent sign-ups by clarifying that applicants must attest that the income projections listed are correct. It also would bar brokers or services who help people enroll in coverage from using "disposable" email addresses, which disappear after a set number of days, or listing the brokers' phone numbers instead of the consumers'.

That there is a proposal at all "tells me they had a significant number of cases on this" and that previous actions have not done enough to curb the problem of people getting fraudulently enrolled, said Tara Straw, director of health insurance and marketplace policy at the Center on Budget and Policy Priorities.

A spokesperson for the Centers for Medicare & Medicaid Services said in an email that the agency is not seeing a pervasive problem, but he declined to provide data on how often such cases occur or how the agents or brokers get the personal information needed to enroll unsuspecting people.

Nonetheless, experts in law, policy and enrollment say it has been a recurrent issue. Many cited examples beginning with a 2015 case in which an agent allegedly signed up hundreds of people from North Carolina homeless shelters for plans in which the federal government paid the entire premium, often referred to as "zero-premium plans," by using questionable estimates of their annual income.

Jodi Ray, who oversees a Florida organization that helps people enroll in coverage, said her employees saw cases last year in which clients seeking help with enrollment in a county health plan discovered they were already enrolled in a federal ACA plan but had no idea who had signed them up.

In another example, a partner organization learned that an agent was enrolling people with job-based coverage in subsidized ACA plans, said Ray, director of Florida Covering Kids & Families, a program at the University of South Florida. Such double enrollment is not allowed under the law and could leave the employees on the hook for paying back the subsidies.

"That sets consumers up to be harmed," said Ray, whose office reports these types of findings to state regulators.

She emphasized that the vast majority of brokers and others who help people enroll are honest and protect consumer information carefully but said that the few who do not create distrust among the public. Groups like hers, often called navigators or assisters, have no incentive to falsify enrollments because they are not paid commissions, she said.

But agents, brokers and web-based services are.

"The profit motive is a really important thing to keep in mind as to why this happens at all," said Straw, who noted that insurers pay commissions even on zero-premium plans.

The proposed changes come as government estimates show that at least 42% of people served by the federal health insurance marketplace likely could qualify for a zero-premium plan based on their income.

That might be one factor behind the growing concern about consumers enrolled without their consent — with no monthly bill, consumers have few ways of knowing they're in a plan.

"There are a lot more zero-dollar premium plans available," said Sabrina Corlette, a researcher at Georgetown University's Center on Health Insurance Reforms. Bad actors "can essentially fake an email address or phone number, fake someone's income to say they are eligible for a zero-dollar plan, and the person would never know."

Regulators have seen "several instances where consumers have gone months" without realizing they are enrolled, according to the proposed HHS rule. By that time, their insurers may have been paid hundreds — even thousands — of dollars in subsidies, also called tax credits, which the policyholder might have to pay back if their actual income is above the subsidy threshold.

Under the ACA, sliding-scale subsidies are available to help low- and moderate-income people buy coverage. Those who underestimate their income for the year may owe back all or part of those subsidies, although payback amounts are capped for those in lower income ranges.

Consumers have some recourse. If they are signed up for coverage without their consent, for example, they can appeal to the federal exchange to retroactively cancel their coverage. But they have only 60 days after discovering the fraudulent enrollment to do so.

"It's complicated to fix on the back end," Straw said.

The health insurance marketplaces and insurers, which can lose customers because of such practices, "need to be more proactive on the front end" — for example, asking questions if they notice "a dozen people with the same address or the same telephone number," she said.

Christine Speidel, an associate professor at Villanova University law school and the director of its federal tax clinic, which helps low-income taxpayers with IRS-related concerns, agrees that prevention is better than fixing the problem after the fact.

"When you have a fraudulent enrollment and it's discovered a year or more later, it's a lose-lose situation: The insurer is screaming, and the taxpayer is frustrated and worried that they might be on the hook," said Speidel, who has not seen a recent case of this kind but has previously handled some in which people did not know they had been enrolled in coverage.

Agents who violate the rules set by the federal exchange can be barred from selling coverage through it or face civil monetary penalties, said Kristine Grow, a spokesperson for AHIP, an industry trade group formerly known as America's Health Insurance Plans. States also can revoke agents' licenses.

"Enrolling people in coverage without their consent is fraud, and health insurance providers support protections for consumers against this sort of fraud," she said.

Consumers who seek help when buying insurance should check to make sure the person selling it is licensed because the problems with fraudulent sign-ups "often are from someone not licensed," said Marcy Buckner, senior vice president of government affairs at the National Association of Health Underwriters, which represents brokers.

The group supports additional protections for consumers, she added.

HHS is gathering comments on the proposed rule through Jan. 27.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

As Omicron Surges, Effort to Vaccinate Young Children Stalls

KFF Health News, January 17, 2022

Pediatricians say the slow pace and geographic disparities are alarming, especially against the backdrop of record numbers of cases and pediatric hospitalizations.

This article was published on Friday, January 14, 2022 in Kaiser Health News.

By Rachana Pradhan and Hannah Recht

Two months after Pfizer's COVID vaccine was authorized for children ages 5 to 11, just 27% have received at least one shot, according to Jan. 12 data from the Centers for Disease Control and Prevention. Only 18%, or 5 million kids, have both doses.

The national effort to vaccinate children has stalled even as the omicron variant upends schooling for millions of children and their families amid staffing shortages, shutdowns and heated battles over how to safely operate. Vaccination rates vary substantially across the country, a KHN analysis of the federal data shows. Nearly half of Vermont's 5- to 11-year-olds are fully vaccinated, while fewer than 10% have gotten both shots in nine mostly Southern states.

Pediatricians say the slow pace and geographic disparities are alarming, especially against the backdrop of record numbers of cases and pediatric hospitalizations. School-based vaccine mandates for students, which some pediatricians say are needed to boost rates substantially, remain virtually nonexistent.

"You have these large swaths of vulnerable children who are going to school," said Dr. Samir Shah, a director at Cincinnati Children's Hospital Medical Center. Compounding the problem is that states with low vaccination rates "are less likely to require masking or distancing or other nonpartisan public health precautions," he said.

In Louisiana, where 5% of kids ages 5 to 11 have been fully vaccinated, Gov. John Bel Edwards, a Democrat, added the shot to the list of required school immunizations for the fall, over the objections of state legislators, who are mostly Republicans. The District of Columbia and California, where about 1 in 5 elementary school kids are fully vaccinated, have added similar requirements. But those places are exceptions — 15 states have banned COVID vaccine mandates in K-12 schools, according to the National Academy for State Health Policy.

Mandates are one of multiple "scientifically valid public health strategies," Shah said. "I do think that what would be ideal; I don't think that we as a society have a will to do that."

Vaccine demand surged in November, with an initial wave of enthusiasm after the shot was approved for younger children. But parents have vaccinated younger kids at a slower pace than 12- to 15-year-olds, who became eligible in May. It took nearly six weeks for 1 in 5 younger kids to get their first shot, while adolescents reached that milestone in two weeks.

Experts cite several factors slowing the effort: Because kids are less likely than adults to be hospitalized or die from the virus, some parents are less inclined to vaccinate their children. Misinformation campaigns have fueled concerns about immediate and long-term health risks of the vaccine. And finding appointments at pharmacies or with pediatricians has been a bear.

"One of the problems we've had is this perception that kids aren't at risk for serious illness from this virus," said Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics Committee on Infectious Diseases. "That's obviously not true."

Parents are left to weigh which is more of a threat to their children: the COVID virus or the vaccine to prevent the virus. Overwhelmingly, research shows, the virus itself presents a greater danger.

Kids can develop debilitating long-COVID symptoms or a potentially fatal post-COVID inflammatory condition. And new research from the CDC found that children are at significantly higher risk of developing diabetes in the months after a COVID infection. Other respiratory infections, like the flu, don't carry similar risks.

Katharine Lehmann said she had concerns about myocarditis — a rare but serious side effect that causes inflammation of the heart muscle and is more likely to occur in boys than girls — and considered not vaccinating her two sons because of that risk. But after reading up on the side effects, she realized the condition is more likely to occur from the virus than the vaccine. "I felt safe giving it to my kids," said Lehmann, a physical therapist in Missouri, where 20% of younger kids have gotten at least one dose.

Recent data from scientific advisers to the CDC found that myocarditis was extremely rare among vaccinated 5- to 11-year-olds, identifying 12 reported cases as of Dec. 19 out of 8.7 million administered doses.

The huge variations in where children are getting vaccinated reflect what has occurred with other age groups: Children have been much less likely to get shots in the Deep South, where hesitancy, political views and misinformation have blunted adult vaccination rates as well. Alabama has the lowest vaccination rate for 5- to 11-year-olds, with 5% fully vaccinated. States with high adult vaccine rates such as Vermont, Massachusetts, Connecticut and Maine have inoculated the greatest shares of their children.

Even within states, rates vary dramatically by county based on political leanings, density and access to the shot. More than a quarter of kids in Illinois' populous counties around Chicago and Urbana are fully vaccinated, with rates as high as 38% in DuPage County. But rates are still below 10% in many of the state's rural and Republican-leaning counties. In Maryland, where 1 in 4 kids are fully vaccinated, rates range from more than 40% in Howard and Montgomery counties, wealthy suburban counties, to fewer than 10% along parts of the more rural Eastern Shore.

Nationally, a November KFF poll found that 29% of parents of 5- to 11-year-olds definitely won't vaccinate their children and that an additional 7% would do so only if required. Though rates were similar for Black, white and Hispanic parents, political differences and location divided families. Only 22% of urban parents wouldn't vaccinate their kids, while 49% of rural parents were opposed. Half of Republican parents said they definitely wouldn't vaccinate their kids, compared with just 7% of Democrats.

The White House said officials continue to work with trusted groups to build vaccine confidence and ensure access to shots. "As we've seen with adult vaccinations, we expect confidence to grow and more and more kids to be vaccinated across time," spokesperson Kevin Munoz said in a statement.

The Hunt for Shots

Just before her younger son's 5th birthday, Lehmann was eager to book COVID vaccine appointments for her two boys. But their pediatrician wasn't offering them. Attempts to book time slots at CVS and Walgreens before her son turned 5 were unsuccessful, even if the appointment occurred after his late-November birthday.

"It was not easy," she said. Wanting to avoid separate trips for her 10-year-old and 5-year-old, she nabbed appointments at a hospital a half-hour away.

"Both of my kids have gotten all their vaccines at the pediatrician, so I was kind of shocked. That would have certainly been easier," Lehmann said. "And the kids know those nurses and doctors, so I think it would have helped to not have a stranger doing it."

The Biden administration has pointed parents to retail pharmacies and 122 children's hospitals with vaccine clinics. Nationwide, more than 35,000 sites, including pediatricians, federally qualified health centers and children's hospitals have been set up to vaccinate young kids, according to the administration. Yet administering the COVID vaccine to children presents obstacles that haven't been as prominent for other inoculations.

Enrolling pediatricians in the COVID-19 vaccine program is a challenge because of the application process, reporting requirements for administered doses, and staffing, said Claire Hannan, executive director of the Association of Immunization Managers.

"Many of them are short-staffed right now and don't necessarily have huge capacity to serve," she said. Plus, "it's not as easy to engage the schools in school-based clinics in certain areas just due to the political environment." Health centers, government officials and other groups have set up more than 9,000 school vaccination sites for 5- to 11-year-olds nationwide.

The CDC's long-standing program, Vaccines for Children, provides free shots for influenza, measles, chickenpox and polio, among others. Roughly 44,000 doctors are enrolled in the program, which is designed to immunize children who are eligible for Medicaid, are uninsured or underinsured, or are from Native or Indigenous communities. More than half of the program's providers offer COVID shots, although the rates vary by state.

Pharmacies have been heavily used in Illinois, where 25% of 5- to 11-year-olds are fully vaccinated.

Dr. Ngozi Ezike, a pediatrician and the director of the Illinois Department of Public Health, said 53% of shots administered to younger children as of Jan. 5 were done at pharmacies. Twenty percent occurred at private clinics, 7% at local health departments, 6% at federally qualified health centers and 5% at hospitals.

"You need all pieces of the pie" to get more kids vaccinated, Ezike said.

Kids Respond to 'the Greater Good'

The Levite Jewish Community Center in Birmingham, Alabama, tried to boost vaccinations with a party, offering games and treats, even a photo booth and a DJ, along with shots given by a well-known local pharmacy. Brooke Bowles, the center's director of marketing and fund development, estimated that about half a dozen of the 42 people who got a dose that mid-December day were kids.

Bowles was struck that children were more likely to roll up their sleeves when their parents emphasized the greater good in getting vaccinated. "Those children were just fantastic," she said. In parts of the Deep South like this one, pro-vaccine groups face a tough climb — as of Jan. 12, only 7% of Jefferson County's children had gotten both shots.

The greater good is what pediatricians have emphasized to parents who are on the fence.

"Children are vectors for infectious disease," said Dr. Eileen Costello, chief of ambulatory pediatrics at Boston Medical Center. "They're extremely generous with their microbes," spreading infections to vulnerable relatives and community members who may be more likely to end up in the hospital.

Seventy-eight percent of the hospital's adult patients have received at least one dose. For children 5 and up, the figure is 39%, with younger children having lower rates than adolescents, Costello said. Particularly amid an onslaught of misinformation, "it has been exhausting to have these long conversations with families who are so hesitant and reluctant," she said.

Still, she can point to successes: A mother who lost a grandparent to COVID was nonetheless reluctant to vaccinate her son with obesity and asthma whom Costello was seeing for a physical. The mother ultimately vaccinated all four of her children after Costello told her that her son's weight put him at higher risk for severe illness.

"That felt like a triumph to me," Costello said. "I think her thinking was, 'Well, he's a kid — he's going to be fine.' And I said, 'Well, he might be fine, but he might not.'"

Methodology

Vaccination numbers are from the Centers for Disease Control and Prevention as of Jan. 12.

National vaccination rates are calculated by the CDC and include vaccinations provided by federal programs such as the Indian Health Service and the Department of Defense, as well as U.S. territories. To compare the vaccination rollout for kids and adolescents, we counted day 0 as the day the CDC approved the vaccine for each age group: May 12, 2021, for 12- to 15-year-olds and Nov. 2, 2021, for 5- to 11-year-olds.

The CDC provides vaccination numbers at the state and county level. These numbers do not include the small fraction of children who were vaccinated by federal programs. To calculate rates for 5- to 11-year-olds, we divided by the total number of kids ages 5 to 11 in each state or county.

To calculate the number of children ages 5 to 11 in each state, we used the U.S. Census Bureau's 2019 Population Estimates Program "single year of age" dataset, the latest release available. For county-level data, we used the National Center for Health Statistics' Bridged Race Population Estimates, which contain single-year-of-age county-level estimates. We selected the 2019 estimates from the 2020 vintage release so the data would reflect the same year as the state-level estimates.

Vaccination data by age is unavailable for Idaho, counties in Hawaii and several California counties. For county-level vaccination data, we excluded states in which the county was unknown for at least 10% of the kids vaccinated in that state.

Visit the Github repository to read more about and download the data.

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

Hannah Recht: hrecht@kff.org, @hannah_recht

Justices Block Broad Worker Vaccine Requirement, Allow Health Worker Mandate to Proceed

KFF Health News, January 14, 2022

The justices removed a temporary halt imposed by a lower court late last year that affected healthcare facilities in half the states.

This article was published on Friday, January 14, 2022 in Kaiser Health News.

By Julie Rovner

The Supreme Court on Thursday blocked a key Biden administration COVID-19 initiative — putting a stop, for now, to a rule requiring businesses with more than 100 workers to either mandate that employees be vaccinated against COVID or wear masks and undergo weekly testing. The rule, which covers an estimated 80 million workers, took effect earlier this week.

At the same time, however, the justices said that a separate rule requiring COVID vaccines for an estimated 10 million health workers at facilities that receive funding from Medicare and Medicaid could go forward. The justices removed a temporary halt imposed by a lower court late last year that affected healthcare facilities in half the states.

In emergency oral arguments held Jan. 7, a majority of the justices seemed dubious that the federal government, through the Occupational Safety and Health Administration, had broad enough authority to require vaccines or tests for the bulk of the nation's private workforce, particularly for a threat that is not job-specific.

Said the unsigned majority opinion: "A vaccine mandate is strikingly unlike the workplace regulations that OSHA has typically imposed. A vaccination, after all, 'cannot be undone at the end of the workday.'"

Three of the court's conservatives — Justices Neil Gorsuch, Clarence Thomas and Samuel Alito — concurred with the decision in a signed opinion that laid out their concerns about OSHA's authority. "The agency claims the power to force 84 million Americans to receive a vaccine or undergo regular testing," they wrote. "By any measure, that is a claim of power to resolve a question of vast national significance. Yet Congress has nowhere clearly assigned so much power to OSHA."

Liberals on the court — where anti-COVID policies are even stricter than those up for debate in the case — were outraged at the majority decision, arguing that just because a threat exists outside the workplace as well as inside, that should not prevent the federal safety agency from regulating it.

Justices Stephen Breyer, Elena Kagan and Sonia Sotomayor wrote in a signed opinion, "When we are wise, we know not to displace the judgments of experts, acting within the sphere Congress marked out and under Presidential control, to deal with emergency conditions. Today, we are not wise."

In the second pair of cases also argued Jan. 7, the justices weighed whether the federal government could place conditions on payments for Medicare and Medicaid to help ensure the safety of the patients whose care is being underwritten.

The health worker rule, said the opinion, also unsigned, "fits neatly within the language of the statute. After all, ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm."

Four conservative justices — Thomas, Alito, Gorsuch and Amy Coney Barrett — dissented in the health worker case, arguing in a signed opinion that "to the extent the rule has any connection to the management of Medicare, and Medicaid, it is at most a 'tangential' one."

President Joe Biden lamented the court's decision on the rule for large workplaces. "As a result of the Court's decision, it is now up to States and individual employers to determine whether to make their workplaces as safe as possible for employees, and whether their businesses will be safe for consumers during this pandemic by requiring employees to take the simple and effective step of getting vaccinated," he said in a statement.

The OSHA rules are opposed by many business groups, led by the small business advocacy organization the National Federation of Independent Business. It argued that allowing the rules to take effect would leave businesses "irreparably harmed," both by the costs of compliance and the possibility that workers would quit rather than accept the vaccine.

The challenge to the Medicare and Medicaid rules, by contrast, came mostly from states, rather than the hospitals, nursing homes and other facilities most directly affected. State officials charge that the rules would jeopardize the ability of healthcare providers, particularly those in rural areas, to retain enough staffers to care for patients.

The cases on the OSHA rule are National Federation of Independent Business v. Department of Labor and Ohio v. Department of Labor. The cases involving the CMS rule are Biden v. Missouri and Becerra v. Louisiana.

Julie Rovner: jrovner@kff.org, @jrovner

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