Becerra also said he will support efforts to bring down drug prices, including allowing importation from such countries as Canada and giving Medicare the ability to negotiate prices.

This article was published on Wednesday, July 14, 2021 in Kaiser Health News.

By Julie Rovner

The Biden administration will support whatever expansions to Medicare Congress is willing to make, Health and Human Services Secretary Xavier Becerra said Tuesday.

Democratic lawmakers on Capitol Hill are working on plans both to add benefits to the health program for seniors and to lower its eligibility age from 65 to 60. But the efforts are mired in competing priorities among different wings of the party as they try to push through a spending plan this year that Republicans have vowed to oppose. President Joe Biden called for the change in Medicare age eligibility while campaigning in 2020.

But asked if the administration has a preference on which Medicare provisions Congress takes up, Becerra said, "Our preference is to get it done. What's the 'it'? We'll take everything we can get."

In a wide-ranging sit-down interview for KHN's "What the Health?" podcast, Becerra also said he will support efforts to bring down drug prices, including allowing importation from such countries as Canada that have lower prices and giving Medicare the ability to negotiate prices.

In addition, he said he's looking forward to efforts to expand the Affordable Care Act, now that it has been upheld — again — by the Supreme Court last month.

As California's attorney general for the previous four years, Becerra led a coalition of Democratic state officials that defended the 2010 health law in that case from efforts by Republican state officials and the Trump administration to have it declared unconstitutional.

"Now we're playing offense," he said. "We've got the ball and we've got to march it down the field, and we intend to because there are many Americans who still need good coverage."

Among the top priorities for the ACA, he said, is maintaining the COVID relief law's temporary increases in subsidies for people who purchase coverage on the health law's marketplaces. Those new subsidies, he said, "have made it possible for countless American families to stay on those affordable health plans."

HHS is ready to engage in the fight over prescription drug prices, according to Becerra. "The president has been pretty explicit," he said. "He is supportive of negotiation of drug prices, so when we get a price for our tens of millions of Medicare recipients and our tens of millions of Medicaid recipients, [we know] that it's the best price we could have bargained for." At the same time, Becerra said, Biden "has supported efforts to import the same drug that cost too much here from another country if it costs less, if we can do it safely."

Becerra, who has been on the job since late March, said his top priority as secretary is to work on health equity issues. "I love that President Biden has said he wants everyone to feel treated equally," he said. "There are a whole bunch of Black and brown communities that have never had the kind of access to care that others have. And when they come to the doctor, they come with the kind of conditions that show they didn't have healthcare before."

Within that broader priority, Becerra said he wants to pay particular attention to the Indian Health Service: "It's time we really focus on our tribal communities and let Indian Country know we really are serious about being good partners."

Another priority is maternal mortality, given in the U.S. "there are women dying in childbirth at greater numbers than in developing countries," he said, and African American mothers die "in some cases at three or four times the rate of white mothers."

Still high on Becerra's to-do list is battling COVID and, particularly, vaccine hesitancy in states where new variants are spreading fast. Of the people who are dying, he said, "more than 99% are unvaccinated. I don't know how you can spin that any other way than to say: If you're vaccinated, you're probably going to live. And if you're unvaccinated, you've done yourself and a lot of other folks a disservice."

But Becerra, who drew criticism from conservatives last week after saying "it is absolutely the government's business" to know who has been vaccinated, continued to shrug off the idea of any sort of federal vaccine registry. The secretary has said those comments were taken out of context and on Tuesday added, "We want to work with our state and local partners."

To hear the conversation or see a transcript, go to KHN's "What the Health?" podcast.

Julie Rovner: jrovner@kff.org, @jrovner

The cost of the proposed expansion, starting in 2023, was put at about $550 million a year.

This article was published on Tuesday, July 13, 2021 in Kaiser Health News.

By Anna Almendrala

SANTA ANA, Calif. — One week the food pantry had frozen crabmeat; other weeks, deli meat or plant-based "meat." The week before the Fourth of July, there was no meat at all, and a reminder that the pantry would be closed the next two weeks.

Even though she never knows exactly what she'll get, Lesli Pastrana is grateful for the Mercado El Sol food pantry. She has frequented it ever since she lost her job in January. On a recent Friday, she walked away with produce, eggs and staples like ramen noodles, pasta and oats.

She and her husband are both in the United States without legal authorization. Before the pandemic, they got by with their wages and the food stamps they received for their two young children — both U.S. citizens.

But now that Pastrana has lost her job at a bowling supplies factory where she worked 10 years, and her husband has been downgraded to part-time work at a warehouse, the couple must save every dollar for their $1,500-a-month, two-bedroom apartment in Tustin. Pastrana is looking for a single room to rent for her family of four. She's worried about her kids.

"I don't want them to focus on the fact that I don't have a job right now," she said. "They don't know the magnitude of the situation, but they can sense the worry."

Additional food stamps could help lighten Pastrana's load and cut down on trips to the food pantry, but like all undocumented immigrants in the U.S., she and her husband are not eligible for these benefits, despite having worked and paid taxes here.

Democrats in the state legislature this year proposed opening California's state-funded food stamp program — which serves about 35,000 authorized immigrants who don't qualify for federal food stamps — to all income-eligible Californians, regardless of immigration status. The cost of the proposed expansion, starting in 2023, was put at about $550 million a year.

But after negotiations with Gov. Gavin Newsom's administration, the proposal was pared down to a two-year, $30 million project to update the state food aid program so it can accept applications from some of the more than 2 million undocumented people in California, should the program be extended to them in the future.

A bill under consideration in the legislature would expand the food stamp benefit to the undocumented once the system is updated and the legislature has appropriated funds for the expansion.

For now, the state has not committed to expanding the program. But the legislature's efforts this year put California at the forefront of extending food aid to unauthorized residents. Advocates say the state has a responsibility to help feed them, especially since hundreds of thousands of undocumented farmworkers toil in California's fields, feeding the state and the rest of the country.

"They're working and risking their lives, not just through the pandemic, but right now through a heat wave," said state Sen. Melissa Hurtado (D-Sanger), co-author of the bill, whose district is in the Central Valley. "They're risking their lives to provide food for us. Why wouldn't we invest in them as well?"

The program would be expensive, and the state would have to foot the whole bill. Right now, California is flush with a $76 billion surplus, but state revenue can swing wildly. For instance, the pandemic's economic restrictions had the Newsom administration projecting a $54 billion deficit just the year before.

California has already expanded eligibility to undocumented immigrants for its Medicaid health coverage program. Since last year it has allowed people under age 26 to participate if they meet income guidelines, at a cost of roughly $450 million annually. Starting in 2022, unauthorized immigrants age 50 and over will be eligible, and the state's annual costs are expected to grow to $1.3 billion by fiscal year 2024.

Up to 1 million unauthorized immigrants would meet the income requirements for food stamps, according to advocate Jared Call of Nourish California, which co-sponsored Hurtado's bill. But the program would likely begin by offering the benefit to subgroups such as children and seniors.

To qualify for food stamps in California, most families would have to earn 200% or less of the federal poverty level for their household size. For a family of four, this would mean grossing no more than $4,368 per month.

The governor's office declined to comment on the "Food for All" proposal and its funding, citing ongoing discussions with the legislature to finalize the budget.

Conservatives have expressed caution. Republican state senators voted as a bloc against Hurtado's bill. In an email explaining his "no" vote, Sen. Brian Jones (R-Santee) said it asks California taxpayers to "bear the burden of a chaotic border situation that is a federal responsibility."

In the Assembly, where committees are debating the bill, member Steven Choi (R-Irvine) suggested the program's generosity would compound problems at the U.S.-Mexico border by encouraging people to try to immigrate to California.

Even Democrats, who hold supermajorities in both houses of the state legislature, are wary of making commitments they can't keep. Food for All would need to be phased in incrementally in case revenues lag or other spending increases, according to an Assembly budget report.

The 2021-22 state budget, which Newsom was expected to sign Monday, includes other measures to make food available to poor people, regardless of immigration status, including more investment in food banks and a program to expand free breakfast and lunch to all California public school students, regardless of income.

The crushing demand for emergency food assistance during the pandemic put a spotlight on food insecurity. In California, more than 3 million residents said they went without sufficient food during the first three months of the pandemic lockdown, up 22% from before it began in March 2020, according to a study by researchers at UCLA's Fielding School of Public Health and Luskin School of Public Affairs.

Food banks in response doubled or tripled their food distribution. Schools, closed for classes, kept cafeterias running so families could drop by every week for free breakfasts and lunches. Nonprofits scrambled to organize emergency grocery deliveries for those sick with COVID-19.

But people behind these efforts say charity food giveaways are stopgap solutions that often distribute unhealthy food, result in massive waste and rob people of choice.

"Food banks get — I don't want to say 'hand-me-down food' — but they often get food near its expiration date," said Claudia Keller, chief mission officer of Second Harvest Food Bank in Orange County. "Food that might be high in sugar, salt and fat. And that, to us, is a disservice to the most vulnerable in our community."

Advocates say there is a better solution to hunger: Simply give families cash or stamps to buy their own food.

Vanessa Terán of Mixteco Indígena Community Organizing Project, on California's Central Coast, said this is why her organization, which primarily serves undocumented immigrant farmworkers, switched from organizing food drives to raising money for prepaid grocery cards.

"People are able to buy what they need, and also there's a shopper's dignity," she said. "They can make choices for their own families that best meet their needs."

The same approach was taken by the federal benefits program — known nationally as SNAP and in California as CalFresh and often called food stamps — which mails beneficiaries grocery-usable cash cards that automatically reload each month.

Undocumented immigrants make up an estimated 8.1% of California's workforce, according to a 2019 summary of data from the Center for Migration Studies think tank. A 2019 analysis by the nonpartisan California Budget & Policy Center estimated the state's undocumented immigrants contribute $3.2 billion annually in state and local taxes.

Hurtado praised her colleagues' decision to expand Medi-Cal to more groups of undocumented immigrants, saying "hunger and health go hand in hand."

"The foundation for good health is having access to adequate food, and healthy food," she said. "But I think that something is better than nothing, and I'm happy with the progress that we're making."

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Academic air quality experts say the technology can be ineffective or potentially create harmful byproducts.

This article was posted on Monday, July 12, 2021 in Kaiser Health News.

By Lauren Weber and Christina Jewett

Stephen Matthew Shumaker counted on in-home, in-person demonstrations to drive his water filtration business, which serves the Atlanta area. So when COVID-19 hit and no one was inviting people indoors, he turned to the air-cleaning part of his operation.

He sent cards in the mail advertising air purifiers using ActivePure technology to new homeowners: "KILL COVID-19, CORONAVIRUS IN YOUR HOME!!"

One card landed on the desk of a postal inspector, who called it false and misleading in a court record. Shumaker then told an undercover agent on the phone on April 24, 2020, that the air purifier "kills the Coronavirus Virus on the spot," according to a criminal complaint.

Weeks later, as Shumaker was heading out the door to his daughter's tennis tournament, eight law enforcement officers detained him. In August, he pleaded guilty to distributing "a pesticide device that was misbranded in that the product label was missing an EPA establishment number." In other words, he failed to follow the letter of a little-known law.

Shumaker told KHN he was just a salesperson and the devices were being shipped straight from the manufacturer. "So I don't know — what am I supposed to do?" he asked. "How do I know if there's a sticker on there or not? I don't have a clue."

The company that makes the devices, ActivePure Technologies, said Shumaker was not an authorized or known salesperson of its products.

The sting is a rare example of enforcement in an arena where money is gushing like a geyser but oversight is nearly nonexistent. Electronic air cleaners, heavily marketed to gyms, doctors' offices and hospitals, companies and schools awash in federal COVID relief funds, tend to use high-voltage charges to alter molecules in the air. The companies selling the devices say they can destroy pathogens and clean the air.

But academic air quality experts say the technology can be ineffective or potentially create harmful byproducts. Companies that make the devices are subject to virtually no standardized testing or evaluation of their marketing claims. A KHN investigation this spring found that over 2,000 schools across the country have bought such technology.

"That's one of the reasons these companies thrive, is that there's nobody, nobody checking every aspect of what they do," said Delphine Farmer, a Colorado State University associate professor who specializes in atmospheric and indoor chemistry.

Regulatory Patchwork

An alphabet soup of federal agencies have truth-in-advertising or product medical device oversight powers but have done little about air cleaners or left broad loopholes. That has left a handful of states to take the most decisive action on the industry.

The Centers for Disease Control and Prevention does not regulate the devices but, like academic air quality experts, recommends time-tested portable HEPA filters to clean the air in rooms. In comparison, ionizing and dry hydrogen peroxide air purifiers have a "less-documented track record" in air cleaning, the CDC says.

The CDC also urges consumers to research the technology and "request testing data." Those reports, though, can be difficult to parse. They include arcane terms like "natural decay" and test conditions that only an expert could spot as different from those that prevail in real life.

The Food and Drug Administration regulates medical devices. But only air purifiers for a direct medical use or that make a medical claim, like relieving allergies, qualify. The FDA doesn't consider ads saying a device can kill a microorganism a "medical claim," spokesperson Shirley Simson said in an email.

Instead, the air purifiers fall under the Environmental Protection Agency's authority as devices marketed to destroy "pests," which include bacteria or viruses. But "unlike chemical pesticides, the EPA does not register devices and, therefore, does not routinely review their safety or efficacy," the agency said.

Trying to fill the gaps, California bans the sale of air purifiers that emit more than a certain level of the toxic ozone gas. The New York State Education Department is "not recommending" that schools buy air purifiers it describes as "ion generators" or "corona discharge technology."

Jeffrey Siegel, a University of Toronto civil engineering professor who studies indoor air quality, said more meaningful national regulation might clarify for consumers how the devices would work in an actual room.

"If you get any serious government oversight, a big chunk of this industry will go away," said Siegel.

'I Was Alone'

While "pesticide" might evoke the idea of a roach killer, the EPA applies the term more broadly: A pesticide is any substance that claims to kill or mitigate pests. Technologies that claim to do the same through physical means — including air purifiers that inactivate bacteria and viruses — are considered pesticide devices.

And while the agency requires proof that pesticides such as some types of Clorox wipes are safe and work in its premarket review, it has no such requirement for so-called pesticide devices — such as electronic air cleaners that deploy ions or "reactive oxygen" to purify the air.

Instead, manufacturers need to obtain what's known as an establishment number indicating where the device is made, and then they and their sellers must label their products with it. That's the step Shumaker pleaded guilty to skipping.

"There is no review associated with that," said James Votaw, a lawyer who specializes in chemical regulation law at Keller and Heckman in Washington, D.C. "That is automatic. It's like trying to get license plates for your car."

So Shumaker told KHN he was baffled as to why he was targeted instead of the corporate level, which in this case would be the company, Aerus, which is now ActivePure Technologies. Dr. Deborah Birx, former adviser to President Donald Trump, joined ActivePure in March as chief medical and science adviser.

"I was alone," Shumaker said in an interview about facing charges. "Nobody backed me up."

Joe Urso, CEO of ActivePure Technologies, told KHN that its studies showing its devices inactivate the virus that causes COVID were not completed until the fall, long after the postcards were sent. Urso said in a statement that his company's devices do have establishment numbers, and that he supports the ruling against Shumaker.

Federal Trade Commission officials have written warning letters to some air cleaner companies during the pandemic. The commission requires claims about a product's safety and efficacy to be supported with "competent and reliable scientific evidence."

One of the last high-profile actions the FTC took against an air purifier company was in 1997, when the Justice Department filed an action on its behalf against Alpine Industries, which made ozone-generating air purifiers. In 2001, a judge fined Alpine $1.49 million for failing to stop making unsubstantiated claims about its devices, which it had said relieved allergies and removed indoor pollutants.

Alpine is a related company to EcoQuest International, according to the FTC. And a majority of EcoQuest International assets were bought in 2009 by ActivePure Technologies, according to its 2021 press kit. ActivePure makes the device Shumaker got into trouble for selling.

Siegel, of the University of Toronto, consulted with U.S. government agencies targeting the misleading marketing claims of some air-cleaner companies about 10 years ago. He finds the company-by-company approach to be a game of "whack-a-mole."

"A company goes away because they have regulatory scrutiny and reinvent themselves a few months later," he said. "The only solution I see to this problem is a government agency really takes ownership of this — the information dissemination to consumers and the claims by manufacturers. I see no other path forward."

'It's Just Buyer Beware'

The Federal Insecticide, Fungicide, and Rodenticide Act, which regulates pesticide devices, was written decades ago and applied to things such as flypaper, long before anyone anticipated machines that would blast ions to clean the air.

"We're just pushing EPA to try and get updated," said Patrick Jones, president of the Association of American Pesticide Control Officials. "It's just buyer beware."

Even before the COVID pandemic, Jones' group was ringing the alarm over the increasing public health claims around pesticide devices. The pesticide control association wrote in a 2019 public comment to the EPA of its concern about the growing use in healthcare facilities of "non-government evaluated pesticide devices that make unsubstantiated human health claims … with no scientific data being submitted to EPA to prove their effectiveness."

EPA spokesperson Tim Carroll said in an email that the agency is developing more outreach materials for schools on air purifiers.

But as few independent authorities assess the effectiveness of the devices, school officials have been snapping them up.

Last summer, the private St. Thomas More School in Kansas City, Missouri, bought ionizing air purifiers to fight COVID. Scott Dulle, the director of building and grounds, said he went with technology he saw health leaders buying.

"We followed the doctors and the hospitals and the government," he said. "They would not put their patients and staff in harm's way."

AAPCO's Jones said changes to federal oversight are needed to better deal with the flood of devices. His solution: If a pesticide device makes a public health claim, it should be evaluated with the same rigor used for pesticides like ant spray.

But to alter the law fundamentally would take congressional action, EPA's Carroll said.

The EPA can prosecute pesticide device companies and sellers under existing laws if a product makes misleading or false claims — and fines can reach into the millions, according to Brandon Neuschafer, a lawyer who specializes in agricultural regulations at the St. Louis-based firm Bryan Cave Leighton Paisner. He noted companies are often turned in by their competitors.

Last fiscal year, Carroll said, the agency issued 19 import refusal notices and sent six advisory letters for COVID-related air-purifying products — a small fraction of its 2020 pesticide actions. Carroll said such investigations are ongoing and a high priority.

But EPA's resources were not the same as they were many years ago, Neuschafer said, as the agency is working with smaller staffing and budgets.

'Worse Indoor Air Quality'

Almost a decade before COVID emerged, New York's education department asked state health officials to test an AtmosAir bipolar ionization unit to see if it would improve the air quality.

During a test in an empty classroom, they found that levels of harmful ozone gas and "ultrafine particles" that can cause cardiovascular problems were elevated, indicating "worse indoor air quality when the AtmosAir Bipolar ionization unit is operating," the 2013 state Bureau of Toxic Substance Assessment report said.

New York State Department of Health officials released the study in response to a KHN public records request about the education department's COVID-era guidance, which urges schools not to buy ionizers.

AtmosAir spokesperson Sarah Berman said the device studied in 2013 is discontinued and "all current products have no affiliation to" it. She also said in an email that tests by third-party labs found that "our bipolar ionization products do not contribute to unacceptable levels" of volatile organic compounds, which are potentially harmful substances.

The California Department of Public Health advised in September against using "air cleaning devices that generate harmful pollutants (i.e., ionization devices or ozone generators)" on the third page of a single-spaced, 44-page document. That guidance was widely overlooked. Districts from Berkeley to Fontana to Culver City bought ionization systems.

But the state does have a one-of-a-kind law: It bans air purifiers that emit anything above a certain level of ozone.

New Jersey doesn't have the same kind of regulation: KHN reported that a public school district there bought thousands of ozone-emitting Odorox devices on the California Air Resources Board's list of "potentially hazardous" air purifiers. Since then, the New Jersey health department posted guidance warning schools about the air purifiers "that may harm health," listing the specific hazards of ozone to children's health.

Back in Georgia, Shumaker was fined more than $9,000 and is on two years' probation.

And the postcards that got him into trouble? Those led to only a handful of sales.

"So it was just like setting money on fire," he said.

Lauren Weber: LaurenW@kff.org, @LaurenWeberHP

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

Faced with criticism over insufficient guidance, the FDA has revised the drug's label to narrow its potential use.

This article was published on Friday, July 9, 2021 in Kaiser Health News.

By Judith Graham

As physicians and health policy experts debate the merits of Aduhelm, the first new drug for Alzheimer's disease approved in 18 years, patients want to know: "Will this medication help me — and how much?"

Doctors explaining the pros and cons of Aduhelm won't have a definitive answer. "On an individual basis, it will be absolutely impossible to predict," said Dr. Allan Levey, director of the Goizueta Alzheimer's Disease Research Center at Emory University.

Cognitive decline varies widely among people who have started experiencing memory and thinking problems or who are in the earliest stage of Alzheimer's — the patients in whom Aduhelm was tested, Levey noted.

"The nature and rate of progression varies tremendously, and we're not going to know when we treat somebody [with Aduhelm] if their progression will be fast or slow or average — we just won't be able to say," Levey explained.

Nor will it be possible to specify how much difference this drug would make for a given patient. "To try to tell an individual how much delay in progression they'll experience [if they take Aduhelm] is simply something we cannot do," said Dr. Jason Karlawish, a professor at the University of Pennsylvania Perelman School of Medicine and co-director of the Penn Memory Center.

Uncertainty about the potential benefits of Aduhelm, which received conditional approval from the Food and Drug Administration on June 7, is considerable. One phase 3 drug trial found that a high dose taken over the course of 18 months slowed cognitive decline by about four months; a second clinical trial failed to show any effect. The FDA is requiring a post-approval trial from drugmakers Biogen and Eisai Inc. to supply more data, but final results might not be available until February 2030.

With many unanswered questions about Aduhelm's approval, the House Committee on Oversight and Reform has opened an investigation. Faced with criticism over insufficient guidance, the FDA on Thursday revised the drug's label to narrow its potential use. "Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials," it now reads.

These developments make the job of educating patients and families about Aduhelm and recommending for or against it extraordinarily difficult for physicians.

Conversations are going to be "very challenging, given the complexity of the information that needs be conveyed." Karlawish said. Here are key points experts aim to explain.

Effectiveness has not been proven. Aduhelm has been shown to be very effective at removing beta-amyloid protein, a hallmark of Alzheimer's, from patients' brains. Clumps of this protein, known as amyloid plaques, are thought to be implicated in the underlying disease process. But clinical trials of other drugs that remove amyloid plaques have not demonstrated effectiveness in stopping Alzheimer's progression.

Although data from two Aduhelm clinical trials was inconsistent, the FDA granted accelerated approval to the drug noting it was "reasonably likely to result in clinical benefit." But this is speculative, not a proven result.

Potential benefits are small. Dr. G. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, was on the FDA advisory committee that reviewed Aduhelm, a group that recommended against approving the medication.

He characterized positive results from one clinical trial of Aduhelm as "a tiny clinical change." On an 18-point scale used to evaluate cognition and functioning, patients who responded to the drug experienced a 0.39 slowing in the rate of decline over 18 months. Roughly, this translates into a four-month delay in subtle symptoms.

Neuropsychological tests to evaluate cognition typically ask patients to copy a diagram, subtract 7 from 100 and spell a word backward, among other tasks. "But navigating your daily life is much more complicated, and it's not at all clear whether Aduhelm's purported benefit would be enough to impact an individual's daily living," said Dr. Samuel Gandy, a professor of neurology and psychiatry at Mount Sinai's Icahn School of Medicine in New York City.

Disease progression will continue. "Let's say someone has cognitive impairment or other functional impairments and decides to take Aduhelm. Will they return to normal? There's no evidence that this will happen," said Dr. Henry Paulson, a professor of neurology and director of the Michigan Alzheimer's Disease Center.

"The expectation has to be that disease progression will continue," agreed Levey of Emory.

Potential side effects are common. Brain bleeds and swelling occurred in 41% of patients treated with the highest dose (10 milligrams) of Aduhelm, the subgroup that showed some response in one clinical trial, according to a document released by the FDA. Brain scans identified these as mild in 30% of cases, moderate in 58% and severe in 13%. Most cases resolved, without serious incident, within three months.

The FDA recommends that patients taking Aduhelm get at least three MRI scans of the brain in the first year to check for side effects. Physicians and health systems are discussing what kind of safety protocols are needed beyond these scans.

Other tests will be necessary. Aduhelm was tested on patients with beta-amyloid deposits in their brain that had been confirmed by positron emission tomography (PET) brain imaging.

In clinical practice, only patients who have those deposits should take Aduhelm and imaging to confirm that should be required, experts agreed. But that presents a problem for many patients. Because of their age, most are covered by Medicare, which doesn't pay for PET imaging outside of research settings. Instead, most medical centers will rely on amyloid cerebrospinal fluid tests, obtained through spinal taps.

Genetic tests for a form of the apolipoprotein E gene known as APOE4, whose presence raises the risk of Alzheimer's, will also probably be in order, Gandy suggested. Patients were more likely to respond to Aduhelm if they carried an APOE4 gene; at the same time, they were more likely to experience brain bleeding and swelling, he noted. But Medicare doesn't pay for APOE4 testing or related counseling, and a positive test could significantly affect patients' families. "Once you find the APOE4 genotype, all those person's first-degree relatives are at risk," Gandy noted, "and you change the psychology of a family immediately."

Therapy will be expensive. Medicare and private insurers have not yet decided whether to impose restrictions on who can get coverage for Aduhelm, which will be administered through monthly infusions at medical centers. Considering an annual list price of $56,000 for the drug alone, KFF researchers estimate that some Medicare beneficiaries could pay as much as $11,500 out-of-pocket to cover their coinsurance obligation.

Add to that the costs for brain scans, monthly infusions, physician services, amyloid tests and APOE4 genetic testing and expenses could approach $100,000 a year, some experts suggest.

"The most pressing thing we need is an understanding of payment for this medication," said Dr. Aaron Ritter, a dementia expert with the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. "Many patients are going to be on a fixed income with limited capacity to pay large amounts." More than 1,000 patients at the clinic are good candidates for Aduhelm, he noted.

Specialists will not prescribe to all Alzheimer's patients. Although physicians can prescribe an approved drug to whomever they think it will help, dementia experts say Aduhelm should be considered only for patients similar to those in the clinical trials: individuals with mild cognitive impairment (memory and thinking concerns that don't interfere with their functioning) and with early-stage Alzheimer's (when symptoms are still mild but functioning becomes impaired).

"We are going to start small and go slow until we understand more" about the medication and how patients respond, said Dr. Maria Torroella Carney, chief of geriatrics and palliative medicine at Northwell Health, New York's largest healthcare system.

Since Aduhelm was not tested on people with moderate or severe Alzheimer's, it shouldn't be given to these patients, several experts said. "If patients in these later stages ask for the drug, we'll say we don't have any evidence that it will work in you and we can't justifiably give it to you," said Paulson of the University of Michigan.

Physicians will respect patients' wishes. Even physicians who worry that Aduhelm's potential harms might outweigh potential benefits said they will prescribe the medication with caution and careful consideration. Karlawish of the University of Pennsylvania is among them.

"Now that this medication is available, I have to adhere to a core ethic of the practice of medicine, which is respect for patient autonomy," he said. "If patients and family caregivers ask for Aduhelm after a thorough discussion, I'll be a reluctant prescriber."

We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the healthcare system. Visit khn.org/columnists to submit your requests or tips.

Judith Graham: khn.navigatingaging@gmail.com, @judith_graham