Six of the top 10 fastest-growing jobs in the decade leading up to 2029 are projected to be in healthcare, including home health and personal care aides.
This article was published on Tuesday, July 13, 2021 in Kaiser Health News.
Jasmine De Moya, 17, has dreamed for years of working in the medical field, and she yearned to spend time with older people, missing her grandparents, who live in the Dominican Republic. A program sponsored by the New Jewish Home health system in New York City that combines volunteering and free training for entry-level health jobs, career coaching and assistance on her college prep is helping make her hopes come alive.
Over the past three years, Jasmine has learned a lot about caring for older people, from the importance of speaking slowly and being gentle with frail residents who may have hearing or comprehension problems to how to brush their teeth or bathe them.
"We practiced first with mannequins, so when we actually [worked on residents] I was in shock," she said. "Cleaning a body and their private areas, I never expected I would do that. But then I got used to it."
Last summer, Jasmine completed a certified nursing assistant training course. She has also researched and applied for colleges and student loans with help from an organization that the geriatrics career development program provides to volunteers like her. After graduating from high school last month, Jasmine will start nursing school at Lehman College in the Bronx in the fall. She'll be the first in her family to attend college.
Since it launched in 2006, the geriatrics career development program has helped more than 700 high school students from 10 underserved schools in New York City get hands-on experience with geriatric care at the New Jewish Home in Manhattan and the Harry and Jeanette Weinberg Gardens senior living facility in the Bronx. Ninety-nine percent of program participants graduate from high school, and more than 150 have gone on to college.
The advantages of the program are also evident for the New Jewish Home, which operates two nursing homes, senior housing and assisted living facilities and a home care business in the New York City area. By familiarizing young people with geriatric care careers, the system aims to address its growing need for workers as the tide of baby boomers enter their later years.
Six of the top 10 fastest-growing jobs in the decade leading up to 2029 are projected to be in healthcare, according to the federal Bureau of Labor Statistics, including home health and personal care aides.
"One of our biggest challenges is that there aren't enough people who want to work in this industry," said Dr. Jeffrey Farber, president and CEO of the New Jewish Home system. "People don't want to work with older adults."
The New Jewish Home began its career development program for teens 15 years ago with the idea of training and hiring them as nursing assistants, Farber said.
But it has become more than that. Working a few afternoons a week for three years with older adults, students gain insights into aging and develop relationships with residents, some of whom are assigned as mentors. It also gives students assistance with figuring out career goals and putting the pieces in place to get there.
"I think the students would be successful without us, but we provide the structure and resources to help them succeed," said John Cruz, senior director of workforce initiatives at the New Jewish Home, who oversees the program.
Students generally must devote two afternoons after school every week and several weeks during the summer, said Cruz. The program curriculum, developed with Columbia University Teachers College, initially teaches students basics about patient privacy, Medicare/Medicaid and overcoming stereotypes about older people. By the time they're seniors in high school, students can train as certified nursing assistants and work as paid interns supporting the residents on the days they spend at the facility.
As part of the program, students may also become certified in other jobs, including patient care technician, phlebotomist, EKG technician, and medical coding and billing staff.
The pandemic, however, changed things. The New Jewish Home in Manhattan was hit hard, with dozens of COVID deaths at the 514-bed facility.
Since volunteers weren't permitted inside the facility, the home instead hired many of them as part-time employees so they could continue to help seniors. This also gave students a chance to complete the clinical training portion of their certified nursing assistant coursework.
In addition to the program for high school students, the health system created a program in 2014 for people ages 18 to 24 who are unemployed and out of school, training them to become certified home health aides and nursing assistants. Nearly 200 have completed the program and the New Jewish Home has hired three-quarters of them, at a starting wage of $15 to $19 an hour.
Both programs are supported primarily by grants from foundations.
In February, the state announced that nursing homes could accept visitors again, following federal guidelines. But many nursing home residents still rely on virtual visits, and during the spring Jasmine spent her time helping them connect with their families and other loved ones by iPad or phone.
The isolation was hard on the residents, and students provided sorely missed company. Asked how the students helped her, resident Dominga Marquez, 78, said, "Just talk."
"We are lonely," said Marquez. "I have a lot of friends that used to come every week to visit but, with the pandemic, nobody came."
Kennedy Johnson, 17, said helping seniors experience virtual visits with their families during the pandemic made him realize how much he takes for granted.
"With the pandemic and doing the virtual calls, seeing how these families don't get to interact with their loved ones every day, that really opened my eyes," he said.
Working at the New Jewish Home was the first time Kennedy had ever been in a nursing home or seen the kinds of work that staff members do.
In the fall, he will start at Morehouse College in Atlanta and plans to major in political science. His goal: "I want to be a healthcare attorney so I can represent people … like this."
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.
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.
Abortion will remain front and center for both parties as the Supreme Court prepares to review a Mississippi law that bans the procedure after 15 weeks and allows no exceptions for cases of rape or incest.
This article was published on Monday, July 12, 2021 in Kaiser Health News.
It took five months for the Biden administration to make a substantive policy change to advance abortion rights. And even that change was buried in a 61-page regulation setting rules for 2022's Affordable Care Act enrollment.
The policy would reverse a Trump administration rule requiring insurers that cover abortion to send separate bills for that coverage. Abortion opponents had hoped the extra paperwork would persuade insurers to stop offering the coverage.
But the new administration's effort also highlights the frustrations abortion-rights advocates have with the slow pace of change from a president they strongly supported — and who courted their votes. "Biden will work to codify Roe v. Wade, and his Justice Department will do everything in its power to stop the rash of state laws that so blatantly violate Roe v. Wade," said his campaign platform.
The late-June action was technically Biden's second move on reproductive rights. Following a recent custom in which presidents taking office from the opposite party have reversed each other's abortion policies, Biden in January gave an initial nod to that campaign promise. He issued an executive order that overturned the so-called Mexico City policy that prohibited U.S. funding of foreign organizations that perform abortions or even lobby for looser abortion laws. It also instructed the Department of Health and Human Services to rewrite a Trump regulation that has effectively shut Planned Parenthood out of the federal family planning program, Title X.
But those Title X changes haven't happened yet, nor has the administration formally moved to undo rules that make it easier for employers to opt out of the ACA mandate to provide no-cost contraception. Also so far unchanged are Trump administration modifications to Medicaid guidance that allow states to ban Planned Parenthood from Medicaid. And abortion rights supporters' concerns are growing after the Supreme Court accepted a Mississippi case that could significantly weaken or even overturn Roe v. Wade, the 1973 ruling that legalized abortion nationwide.
In fact, to the consternation of reproductive rights advocates, Biden has apparently not even uttered the word "abortion" as president. A website is keeping track.
None of that, however, has stopped abortion opponents from painting the president and his administration as pro-abortion crusaders. "Once a supporter of policies that protect the lives of the unborn and their mothers, President Biden today caters to the most extreme voices within his party," said a statement from the Susan B. Anthony List in May. The statement was in response to Biden's keeping a campaign pledge to submit a budget calling for Congress to eliminate the Hyde Amendment, which for years has forbidden most federal abortion funding, particularly affecting low-income women in the Medicaid health program. It's named after former Republican Rep. Henry Hyde of Illinois.
It's true that Biden, a practicing Roman Catholic whose stance is criticized by many U.S. bishops, used to be much less supportive of abortion than he is today. But abortion moderates are a disappearing species in both political parties.
As recently as the 1990s, Democrats and Republicans jointly led "pro-life" and "pro-choice" caucuses in Congress. In 1991 an estimated third of Democrats in the U.S. House voted with anti-abortion advocates. A smaller but still significant minority of Republican House members voted with abortion-rights backers. The Senate was similarly divided. The divisions through the '90s helped explain why Democrats, even when they controlled both houses of Congress and the White House, were unable to eliminate the Hyde Amendment or codify abortion rights (they tried both).
Since then, though, both parties have retreated more firmly to their respective corners on reproductive health. Despite some complaints, the 2020 Democratic platform calls for repealing the Hyde Amendment, and the 2016 GOP platform (there was no formal platform in 2020) asserts that "the unborn child has a fundamental right to life which cannot be infringed." Anti-abortion Democrats in each chamber of Congress can be counted on one hand, as can Republican abortion-rights supporters.
The shift clearly has a lot to do with the replacement of Democratic conservatives in the South — many of whom opposed abortion — with Republicans. Along with that came redistricting, which has created more reliably red and blue districts. In a heavily Democratic or Republican district, politicians out of alignment with the majority of their party on issues such as abortion are more likely to draw primary opposition and less likely to raise money from activists.
But it's not just Democrats who are retreating from the middle of the abortion debate. In 1992, the Senate approved a bill by an overwhelming margin that would specifically allow federal funding of research on fetal tissue left over from elective abortions. Among the Republicans who voted for that measure who are still in the Senate are current Minority Leader Mitch McConnell and Chuck Grassley (R-Iowa).
By the time the issue returned to the political agenda in 2015, McConnell and Grassley had changed their positions.
Abortion will remain front and center for both parties as the Supreme Court prepares to review a Mississippi law that bans the procedure after 15 weeks and allows no exceptions for cases of rape or incest.
But Democrats will be tested most immediately. Progressives are determined to vote to eliminate the Hyde Amendment. Yet direct federal abortion funding makes even some abortion-rights backers squeamish, as Biden was until 2020 when, under some duress, he promised to sign the repeal if it came to his desk. As always, abortion remains a political high wire.
HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN's chief Washington correspondent, Julie Rovner, who has covered healthcare for more than 30 years.
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 andwork 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 nowActivePure 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 someair 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.
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.
Though patients will start taking it, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.
This article was published on Monday, July 12, 2021 in Kaiser Health News.
The Food and Drug Administration's approval in June of a drug purporting to slow the progression of Alzheimer's disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug's mixed results in studies — the FDA's own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid.
But lost in this discussion is the underlying problem with using the FDA's "accelerated" pathway to approve drugs for conditions such as Alzheimer's, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.
The accelerated approval process, begun in 1992, is an outgrowth of the HIV/AIDS crisis. The process was designed to approve for sale — temporarily — drugs that studies had shown might be promising but that had not yet met the agency's gold standard of "safe and effective," in situations where the drug offered potential benefit and where there was no other option.
Unfortunately, the process has too often amounted to a commercial end run around the agency.
The FDA explained its controversial decision to greenlight the Biogen pharmaceutical company's latest product: Families are desperate, and there is no other Alzheimer's treatment. Also, importantly, when drugs receive this type of fast-track approval, manufacturers are required to do further controlled studies "to verify the drug's clinical benefit." If those studies fail "to verify clinical benefit, the FDA may" — may — withdraw them.
But those subsequent studies have often taken years to complete, if they are finished at all. That's in part because of the FDA's notoriously lax follow-up and in part because drugmakers tend to drag their feet. When the drug is in use and profits are good, why would a manufacturer want to find out that a lucrative blockbuster is a failure?
Historically, so far, most of the new drugs that have received accelerated approval treat serious malignancies.
And follow-up studies are far easier to complete when the disease is cancer, not a neurodegenerative disease such as Alzheimer's. In cancer, "no benefit" means tumor progression and death. The mental decline of Alzheimer's often takes years and is much harder to measure. So years, possibly decades, later, Aduhelm studies might not yield a clear answer, even if Biogen manages to enroll a significant number of patients in follow-up trials.
Now that Aduhelm is shipping into the marketplace, enrollment in the required follow-up trials is likely to be difficult, if not impossible. If your loved one has Alzheimer's, with its relentless diminution of mental function, you would want the drug treatment to start right now. How likely would you be to enroll and risk placement in a placebo group?
The FDA gave Biogen nine years for follow-up studies but acknowledged that the timeline was "conservative."
Even when the required additional studies are performed, the FDA historically has been slow to respond to disappointing results.
In a 2015 study of 36 cancer drugs approved by the FDA, only five ultimately showed evidence of extending life. But making that determination took more than four years, and over that time the drugs had been sold, at a handsome profit, to treat countless patients. Few drugs are removed.
It took 17 years after initial approval via the accelerated process for Mylotarg, a drug to treat a form of leukemia, to be removed from the market after subsequent trials failed to show clinical benefit and suggested possible harm. (The FDA permitted the drug to be sold at a lower dose, with less toxicity.)
Avastin received fast-track approval as a breast cancer treatment in 2008, but three years later the FDA revoked the approval after studies showed the drug did more harm than good in that use. (It is still approved for other, generally less common cancers.)
In April, the FDA said it would be a better policeman of cancer drugs that had come to markets via accelerated approval. But time — as in delays — means money to drug manufacturers.
A few years ago, when I was writing a book about the business of U.S. medicine, a consultant who had worked with pharmaceutical companies on marketing drug treatments for hemophilia told me the industry referred to that serious bleeding disorder as a "high-value disease state," since the medicines to treat it can top $1 million a year for a single patient.
Aduhelm, at $56,000 a year, is a relative bargain — but hemophilia is a rare disease, and Alzheimer's is terrifyingly common. Drugs to combat it will be sold and taken. The crucial studies that will define their true benefit will take many years or may never be successfully completed. And from a business perspective, that doesn't really matter.
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.
Contrary to pharmaceutical industry arguments that large profits fund extensive research, the major drug companies plow more of their billions in earnings back into their own stocks, dividends and executive compensation.
This article was published on Friday, July 9, 2021 in Kaiser Health News.
The largest drug companies are far more interested in enriching themselves and investors than in developing new drugs, according to a House committee report released Thursday that argues the industry can afford to charge Medicare less for prescriptions.
The report by the House Oversight and Reform Committee says that contrary to pharmaceutical industry arguments that large profits fund extensive research and innovation, the major drug companies plow more of their billions in earnings back into their own stocks, dividends and executive compensation.
And they can do it largely because Congress has imposed few restrictions on their pricing in the United States — including in the Medicare program, which is not permitted to negotiate drug prices, House Democrats say.
"What we have found is shocking," said Oversight Committee Chair Carolyn Maloney (D-N.Y.). "Drug companies are actively and intentionally targeting the United States for price increases, often while cutting prices in the rest of the world."
According to the data crunched by the committee, the 14 largest drug manufacturers paid themselves and investors $578 billion from 2016 to 2020 through dividends and stock buybacks, while investing $56 billion less — $522 billion — on research and development.
On top of that, the report says, some of that R&D money is spent researching ways to suppress competition, such as by filing hundreds of new, minor patents on older drugs that make it harder to produce generics.
"Despite Big Pharma's lip service about innovation, many drug companies are not actually spending significant portions of their research-and-development budget to discover innovative new treatments," Maloney told reporters in a conference call. "Instead, these companies are spending their research-and-development dollars on finding ways to game the system."
"How can Pharma say with a straight face … that lower drug prices for Americans will have to come at the expense of research and development?" House Speaker Nancy Pelosi asked on the call.
The release of the report during a congressional recess seemed aimed at least partly at boosting support for the House Democrats' Lower Drug Costs Now Act, which, among other things, would allow Medicare to negotiate drug prices, let Americans with private insurance pay those same rates and limit U.S. prices to an average price other countries pay.
Pelosi said she would like to see the measure, numbered H.R. 3, included in a massive bill that Democrats are preparing under what is known as the budget reconciliation process. That process allows taxing and spending bills to be packaged together and get though the Senate on a simple majority vote exempt from a filibuster. Democrats are expected to use the process for a number of key initiatives, including possible changes in Medicare eligibility and benefits, outlined by President Joe Biden and congressional leaders and panned by Republicans.
"With the savings on the lower drug prices, we can invest in transformational improvements in American healthcare," Pelosi said. "We have an historic opportunity to do so as we craft the reconciliation bill. We'll see how we proceed there."
Some more moderate Democrats have raised concerns about H.R. 3, in part echoing industry assertions that curbing drugmakers' revenues might cut their ability to innovate. Pelosi can afford to have only a handful of Democrats defect in the House, and all 50 Democrats in the Senate are needed to pass a reconciliation measure.
Among the starker examples the report highlights, the company Novo Nordisk spent twice as much on executive pay and buying back its own stock as on R&D over the five years.
The drugmaker Amgen especially cashed in on the 2017 tax cuts pushed through a Republican Congress, spending five times as much on buybacks as on research, the report says.
According to the report, if the 14 large companies maintain roughly their current practices, they will pay themselves and investors $1.15 trillion over the next decade, which the committee notes is double the estimated cost of H.R. 3.
The report also singles out internal documents from the pharmaceutical giant AbbVie as an illustration of "research and development" being aimed at suppressing cheaper competition, in this case by seeking new minor patent enhancements on the rheumatoid arthritis drug Humira, which costs $77,000 a year.
"An internal presentation emphasized that one objective of the 'enhancement' strategy was to 'raise barriers to competitor ability to replicate,'" the report says, likely delaying lower-priced biosimilar drugs at least until 2023. It also notes that the company identified about $5.19 billion in R&D for Humira, about 7.4% of the drug's net U.S. revenue.
In another case, the report highlights an internal presentation from Celgene, which makes the $16,744-a-month cancer drug Revlimid and has since been bought by Bristol Myers Squibb.
The report says Celgene targeted the United States for its profitable price hikes and admitted in a presentation that it was because of the country's "highly favorable environment with free-market pricing."
In some other cases, the combined $3.2 billion that the 14 companies' top management earned over the five years was conditioned on U.S. price hikes.
A spokesperson for Novo Nordisk said its buybacks were entirely justified and included them in what he described as the company's overall long-term investments.
"These investments have led to the discovery of innovative treatments that have made substantial impacts on peoples' lives," said Michael Bachner, director of communications for Novo Nordisk.
"Given the complex challenges in the healthcare system, we remain committed to developing solutions in cooperation with policymakers and other stakeholders," he said. "We will continue to work towards maintaining a sustainable business that will foster innovation and provide patients with access to needed new therapies."
Frank Benenati, a spokesperson for AbbVie, took issue with the report's emphasis on Humira's R&D costs. He said the report "is misleading in that it focuses on the R&D spend for one drug, not the total R&D spend, which was approximately $50 billion since 2013."
Other companies did not immediately answer requests for comment, but a spokesperson for the industry's lobbying arm, the Pharmaceutical Research and Manufacturers of America, said the release of the report was political and aimed at backing legislation that PhRMA said would harm Medicare.
"While we can't speak to specific examples cited in the report, this partisan exercise is clearly designed to garner support for an extreme bill that will erode Medicare protections and access to treatments for seniors," said PhRMA spokesperson Brian Newell. "Every year, biopharmaceutical research companies invest tens of billions of dollars in the research and development of new cures and treatments, as well as our significant investments in time and resources creating treatments and vaccines to combat the global pandemic."
Despite the report, he said, net prices on drugs are coming down, when rebates to customers are included. He added that the greater problems are with high deductibles charged by insurers and with profits taken by middlemen such as pharmacy benefit managers.
"We are committed to working with policymakers on commonsense, bipartisan solutions that address the real challenges patients face," Newell said. "Working together we can make sure medicines are affordable and accessible for everyone."
A federal court's decision could mean that hospitals will need to revise their policies barring workers from talking to the news media and posting on social media.
This article was published on Friday, July 9, 2021 in Kaiser Health News.
Karen Jo Young wrote a letter to her local newspaper criticizing executives at the hospital where she worked as an activities coordinator, arguing that their actions led to staffing shortages and other patient safety problems.
Hours after her letter was published in September 2017, officials at Maine Coast Memorial Hospital in Ellsworth, Maine, fired her, citing a policy that no employee may give information to the news media without the direct involvement of the media office.
But a federal appellate court recently said Young's firing violated the law and ordered that she be reinstated. The court's decision could mean that hospitals and other employers will need to revise their policies barring workers from talking to the news media and posting on social media.
Those media policies have been a bitter source of conflict at hospitals over the past year, as physicians, nurses and other health care workers around the country have been fired or disciplined for publicly speaking or posting about what they saw as dangerously inadequate COVID-19 safety precautions. These fights also reflect growing tension between health care workers, including physicians, and the increasingly large, profit-oriented companies that employ them.
On May 26, the 1st U.S. Circuit Court of Appeals unanimously upheld a National Labor Relations Board decision issued last year that the hospital, now known as Northern Light Maine Coast Hospital, violated federal labor law by firing Young for engaging in protected "concerted activity." The NLRB defines it as guaranteeing the right to act with co-workers to address work-related issues, such as circulating petitions for better hours or speaking up about safety issues. It also affirmed the board's finding that the hospital's media policy barring contact between employees and the media was illegal.
"It's great news because I know all hospitals prefer we don't speak with the media," said Cokie Giles, president of the Maine State Nurses Association, a union. "We are careful about what we say and how we say it because we don't want to bring the hammer down on us."
The 1st Circuit opinion is noteworthy because it's one of only a few such employee speech rulings under the National Labor Relations Act ever issued by a federal appellate court, and the first in nearly 20 years, said Frank LoMonte, a University of Florida law professor who heads the Brechner Center for Freedom of Information.
The 1st Circuit and NLRB rulings should force hospitals to "pull out their handbook and make sure it doesn't gag employees from speaking," he said. "If you are fired for violating a 'don't talk to the media' policy, you should be able to get your job back."
The American Hospital Association and the Federation of American Hospitals declined to comment for this article.
While the 1st Circuit's opinion is binding only in four Northeastern states plus Puerto Rico, the NLRB decision carries the force of law nationwide. The case applies to both unionized and non-unionized employees, legal experts say.
Hospitals and health care organizations often have policies requiring employees to clear any public comments about the workplace with the organization's media office. Many also have policies restricting what employees can say on Facebook and other social media.
Hospitals say requiring employees to go through their media office prevents the spread of inaccurate information that could damage the public's confidence. In Young's case, the hospital argued that her letter contained false and disparaging statements. But the 1st Circuit panel agreed with the NLRB that her letter was "not abusive" and that its only false statement was not her fault.
Health care organizations have undisputed legal authority to prohibit employees from disclosing confidential patient information or proprietary business information, legal experts say.
But the 1st Circuit panel made clear that an employer cannot bar an employee from engaging in "concerted actions" — such as outreach to the news media — "in furtherance of a group concern." That's true even if the employee acted on her own, as Young did in writing her letter. The key in her case was that she "acted in support of what had already been established as a group concern," the court said.
"I think employers with a blanket ban on talking to the media need to relook at their policies," said Eric Meyer, a partner at FisherBroyles in Philadelphia who often represents companies on employment law matters. "If you go to the media and say, 'There are unsafe working conditions impacting me and my colleagues,' that's protected concerted activity."
Chad Hansen, Young's attorney in a separate federal lawsuit alleging discrimination based on a disability against the hospital, said she has not yet been reinstated to her job. Young would not comment.
The hospital's parent company, Northern Light Health, said only that its news media policy — which was amended after Young's firing — meets the NLRB and 1st Circuit requirements and will not be further changed. The new policy created an exception allowing employees to speak to the news media related to concerted activities protected by federal law.
Speech rights under the National Labor Relations Act are particularly important for employees of private companies. Although the Constitution protects people who work for public hospitals and other government employers with its guarantee of unrestricted speech, employees at private companies do not have a First Amendment right to speak publicly about workplace issues.
"I hope this case keeps alive the right of health care workers to speak out about something that's dangerous," said Dr. Ming Lin, an emergency physician who lost his job last year at PeaceHealth St. Joseph Medical Center in Bellingham, Washington, after publicly criticizing the hospital's pandemic preparedness.
Lin, who was employed by TeamHealth, which provides emergency physician services at the hospital, lost his assignment at PeaceHealth in March 2020 soon after saying on social media and in interviews with news reporters that PeaceHealth was not taking urgent enough steps to protect staff members from COVID. He had worked at the hospital for 17 years.
In an April 2020 YouTube interview, PeaceHealth's chief operating officer, Richard DeCarlo, said Lin was removed from the hospital's ER schedule because he "continued to post misinformation, which was resulting in people being afraid and being scared to come to the hospital." DeCarlo also alleged that Lin, who was out of town for part of the time he was posting, refused to communicate with his supervisors in Bellingham about the situation. PeaceHealth declined to comment for this article.
PeaceHealth's social media policy at that time stated that the company does not prohibit employees from engaging in federally protected concerted activity and that they "are free to communicate their opinions." TeamHealth's social media policy, dated July 15, 2020, states the company reserves the right to take disciplinary action in response to behavior that adversely affects the company.
Lin, who's now working for the Indian Health Service in South Dakota, has sued PeaceHealth, TeamHealth and DeCarlo in state court in Washington claiming wrongful termination in violation of public policy, breach of contract and defamation.
Dr. Jennifer Bryan, board chair of the Mississippi State Medical Association, who publicly defended two Mississippi physicians fired for posting about the inadequacy of their hospitals' COVID safety policies, said she faced pressure from her hospital for speaking to the news media without approval.
The medical association pushed its members to talk to the media about the science of COVID, while employers insisted doctors' messages had to be approved by the media office. That reflected a conflict, she said, between medical professionals primarily concerned about public health and executives of for-profit systems who were seeking to shield their corporate image.
Bryan predicted the court ruling and NLRB decision will be helpful. "Physicians have to be able to stand up and speak out for what they believe affects the safety and well-being of patients," she said. "Otherwise, there are no checks and balances."
I set out to test that statement by comparing prices in two major California hospital systems. I am sorry to report that, at least for now, that status quo — the tangled web that long has cloaked hospital pricing — is alive and well.
I have spent hours toggling among multiple spreadsheets, each containing thousands of numbers, in an effort to compare prices for 20 common outpatient procedures, such as colonoscopies, cataract surgeries, hernia repair and removal of breast lesions.
After three months of glazed eyes and headaches from banging my head against walls of numbers, I am throwing in the towel. It was a fool's errand. My efforts ultimately yielded just one helpful piece of advice: Don't try this at home.
I was most of the way to that realization when a conversation with Shawn Gremminger helped push me over the line.
"You are a healthcare reporter, I'm a healthcare lobbyist, and the fact that we can't do this ourselves is an indictment of where things stand at this point," said Gremminger, health policy director at the Purchaser Business Group on Health, which represents large employers who pay their employees' medical bills directly and have a big stake in price transparency. "The subset of people who can do this is pretty small, and most of them work for hospitals."
I heard similar comments from other veterans of the healthcare industry, even from the former managed-care executive who inspired the story.
He had come to me with a spreadsheet full of price info that appeared to show that a Kaiser Permanente hospital in the East Bay charged significantly higher prices for numerous procedures than a nearby hospital run by archcompetitor Sutter Health.
That was a compelling assertion, since Sutter is widely viewed in California as the poster child for excessive prices. Nearly two years ago, Sutter settled a high-profile antitrust case that accused the hospital system of using its market dominance in Northern California to illegally drive up prices.
I knew from the outset it would be tricky to compare Kaiser and Sutter because, operationally, they are apples and oranges.
Sutter negotiates separate deals with numerous health plans, and its prices can vary by thousands of dollars for the same service, depending on your insurance. Kaiser's hospitals are integrated with its insurance arm, which collects premiums — so, in effect, it is playing with house money. There is just one Kaiser health plan price for each medical service.
Still, the story seemed worth looking into. Those Sutter and Kaiser prices matter, because they are used to calculate how much patients pay out of their own pockets. And helping patients know what they'll owe in advance is one of the goals of the transparency rule.
The federal rule requires hospitals to report prices for all the medical services they provide in huge spreadsheets that can be processed by computers.
It also obliges them to provide prices in a more "consumer-friendly" format for 300 so-called shoppable services, which are procedures that can be scheduled in advance. And it requires that they report the cost of any "ancillary services," such as anesthesia, typically rendered in concert with those procedures. Of the 300 "shoppables," 70 are specified by the government and the rest are chosen by each hospital.
Most of the 20 common medical procedures I attempted to compare were among those 70. But a few, from lists of top outpatient procedures provided by the Healthcare Cost Institute, were not. I decided to use the more comprehensive, less friendly spreadsheets for my comparisons, since they contained all 20 of the procedures I'd chosen.
Each carried a five-digit medical code known as a CPT, a term trademarked by the American Medical Association that stands for "current procedural terminology." The transparency rule requires hospitals to include billing codes, because they supposedly provide a basis for price comparison, or in the rule's jargony language, "an adequate cross-walk between hospitals for their items and services."
Much to my chagrin, I soon discovered they don't provide an adequate crosswalk even within one hospital.
My first inkling of the insuperable complexity came when I noticed that Sutter's Alta Bates Summit Medical Center in Oakland listed the same outpatient procedure with the same CPT code three times, thousands of rows apart, with entirely different prices. CPT 64483 is the designated code for injection of anesthetics or steroids into a spinal nerve root with the use of imaging, which relieves pain in the lower back, legs and feet caused by sciatica or herniated discs. The spreadsheet showed a maximum negotiated price of $1,912 in row 12,718, $3,650.85 in row 19,014 and $5,475.80 in row 19,559 (let your eyes glaze over for just a few seconds, so you know what it feels like). The reason for the triple listing is tied to Medicare billing guidelines, Sutter later told me. I'll spare you the details.
My head really began to hurt when I decided to double-check some of the prices I had pulled from the big spreadsheets against the same items on the shorter shoppables sheets. Kaiser's prices were generally consistent across the two, but for Alta Bates, there were large discrepancies.
The highest negotiated price for removing a breast lesion, for example, was $6,156 on the big sheet and $23,069 on the shorter one. The difference seems largely attributable to the estimated cost of additional services, some rather nonspecific, that Sutter lists on the smaller sheet as accompaniments to the procedure: anesthesia, EKG/ECG, imaging, laboratory, perioperative, pharmacy and supplies.
But why not include them in both spreadsheets? And what do the two dramatically divergent prices actually encompass?
"How many bills they really represent and what they mean is difficult to interpret," said Dr. Merrit Quarum, CEO of Portland, Oregon-based WellRithms, which helps employers negotiate fair prices with hospitals. "It depends on the timing, it depends on the context, which you don't know."
In some cases, Sutter said, its shoppables spreadsheets show charges not only for ancillary services typically rendered on the day of the procedure, but also for related procedures that may precede or follow it by days or weeks.
The listings for Kaiser's ancillary services do not always match Sutter's, which further clouds the comparison. The problematic fact of the matter is that hospitals performing the same procedures bundle their bills differently, use different medications, estimate varying amounts of time in the operating room, and utilize more or less advanced technology. And physician charges are not even included in the posted prices, at least in California.
All of which makes it almost impossible for mere mortals to anticipate the total cost of their medical procedures, let alone compare prices among hospitals. Even if they could, it might be of limited value, since independent imaging centers and surgery centers, which are increasingly common — and generally less expensive — aren't required to report their prices.
The bottom line, I'm afraid, is that despite my efforts I don't have anything particularly insightful to reveal about how Kaiser's prices compare with Sutter's. The prices I examined were as transparent to me as hieroglyphics, and I'm pretty sure that hospital executives — who unsuccessfully sued to stop implementation of the price transparency rule — are not losing any sleep over that fact.
GRAND JUNCTION, Colo. — Dr. Rachel LaCount grasped a metal hoop at a playground and spun in circles with her 7-year-old son, turning the distant mesas of the Colorado National Monument into a red-tinged blur.
LaCount has lived in this western Colorado city of 64,000 nearly her whole life. As a hospital pathologist, she knows better than most that her hometown has become one of the nation's top breeding grounds for the delta variant of COVID-19.
"The delta variant's super scary," LaCount said.
That highly transmissible variant, first detected in India, is now the dominant COVID strain in the United States. Colorado is among the states with the highest proportion of the delta variant, according to the Centers for Disease Control and Prevention.
Mesa County has the most delta variant cases of any county in Colorado, state health officials report, making the area a hot spot within a hot spot. A CDC team and the state's epidemiologist traveled to Grand Junction to investigate how and why cases of the variant were moving so quickly in Mesa County.
At her hospital, LaCount has put in orders for more rapid COVID tests as the caseload has grown. She's seen the intensive care unit start filling up with COVID patients, so that hospital officials are placing two in a room against normal practices.
Despite these alarming signs, many in Mesa County have let down their guard. The rate of eligible residents fully vaccinated has stalled at about 42%. LaCount has noticed that few people wear masks anymore at the grocery store. Thousands of people recently flocked to Mack, 20 miles from Grand Junction, to attend the Country Jam music festival, which could accelerate the variant's spread to the concertgoers' hometowns.
"We're making national news for our COVID variant and the CDC is here investigating, but we have a huge festival where people aren't masking," said LaCount. "Are we going to get herd immunity over here just because everyone's going to get it? I mean, that's probably going to happen at some point, but at what cost?"
LaCount's worries aren't necessarily for herself or her spouse — they are both vaccinated — but for their son, who can't be vaccinated because he is under 12. She is uneasy about sending him to school in the fall for fear of exposure to the variant. She is reluctant to take him to birthday parties this summer knowing there's a good likelihood he'll be teased for wearing a mask.
A few yards away from LaCount and her son on the playground, a man fished in a still pond with his 10-month-old daughter in a backpack. Garrett Whiting, who works in construction, said he believes COVID is still being "blown out of proportion," especially by the news media.
"They got everybody scared really, really fast," said Whiting, slowly reeling in a sparkly blue lure from the water. "There's no reason to stop living your life just because you're scared of something."
Whiting tested positive for COVID about three months earlier. He said he doesn't plan to get vaccinated, nor does his wife. As for the baby on his back, he said he's not sure whether they'll have her vaccinated when regulators approve the shot for young children.
The delta variant is one of six "variants of concern" circulating in the U.S., according to the CDC, because the delta strain spreads more easily, might be more resistant to treatment and might be better at infecting vaccinated people than other variants.
The delta variant has raised alarms around the world. Parts of Australia have locked down again after the variant leapfrogged its way from an American aircrew to a birthday party where it infected all unvaccinated guests, health officials said, and after it also jumped between shoppers in a "scarily fleeting" moment in which two people walked past each other in a mall. Israel reissued an indoor mask requirement after a spate of new cases linked to schoolchildren. A leading health official there said about a third of the 125 people who were infected were vaccinated, and most of the new infections were delta variant.
A rise in delta variant cases delayed the United Kingdom's planned reopening in June. But public health officials have concluded after studying about 14,000 cases of the delta variant in that country that full vaccination with the Pfizer-BioNTech vaccine is 96% effective against hospitalization. Studies around the world have made similar findings. There is also evidence the Moderna and Johnson & Johnson vaccines are effective against the variant.
Los Angeles County recently recommended that residents resume wearing masks indoors regardless of vaccination status, over concern about the delta variant. The World Health Organization is also urging vaccinated people to wear masks, though the CDC hasn't changed its guidelines allowing vaccinated people to gather indoors without masks.
The variant arrived in Mesa County this spring, when it accounted for just 1% of all cases nationwide, said Jeff Kuhr, executive director of Mesa County Public Health.
"We were winding down just like everyone else. We were down to less than five cases a day. I think we had about two people hospitalized at one point," Kuhr said. "We felt as if we were out of the woods."
He even signed off on Country Jam, which bills itself as the state's "biggest country music party."
But in early May, the delta variant appeared in a burst, with five cases among adults working for the school district.
"It started to hit the children, those that were not of the age to be vaccinated," Kuhr said. "That was telling me that, you know, wearing masks in school was not providing the protection with this new variant that it had previously."
The county then started to see breakthrough cases in fully vaccinated elderly residents in long-term care facilities. The hospitals began to fill once more. Nine vaccinated people died, seven of them since the delta variant's arrival, though it's still unclear whether the variant is to blame. All were at least 75 years old, and seven lived in long-term care facilities. Now, Kuhr estimates, "above 90%" of cases in the county are delta variant.
The county is seeing the same trend as the state: The vast majority of people testing positive for COVID, and people being hospitalized with it, are unvaccinated. "It's a superspreader strain if there ever was one," Eric Topol with the Scripps Research Institution told Scientific American. But he said people fully vaccinated with Pfizer or Moderna shots "should not worry at all." There is less information about the protection offered by Johnson & Johnson's vaccine.
Mesa County health officials considered canceling the music festival, but "it was really too late," Kuhr said. After the announcement that the festival was on, about 23,000 people bought tickets.
Officials weighed banning alcohol or trying to get attendees a Johnson & Johnson single-dose vaccine in the weeks leading up to the festival. In the end, they settled on messaging: signs warning people online and at the venue that the area was a COVID hot spot.
According to CDC guidance, outdoor events were low risk. A sporting event at the end of May in Grand Junction that filled a baseball stadium had resulted in only one known case, which made Kuhr optimistic.
"We put messaging on Country Jam's website, and then in their social media pages, saying, you know, 'Mesa County's a hot spot. Be prepared,'" Kuhr said.
A stormy Friday dampened concert attendance at Country Jam. But on the last day of the festival, the sun was out and throngs of cowboy boot-clad concertgoers stepped around prairie dog burrows and kicked up gray-yellow dust on the path to the venue entrance.
Many reveled in being able to attend a summertime event like an outdoor festival, taking it as another sign that the pandemic was waning.
"COVID is over in Colorado," said Ryan Barkley, a college student from Durango who was playing beer pong in an inflatable pool at his campsite outside the gates.
That day, 39 people in the county were hospitalized with COVID, and a CDC investigative team had arrived just four days earlier.
Inside the gates, an open field was filled with stages, concession stands, and vendors selling cowboy hats, coffee mugs and hunting clothes — and crowds of people. Chelsea Sondgeroth and her 5-year-old daughter took in the scene.
"It's just nice to see people's faces again," said Sondgeroth, who lives in Grand Junction and previously had COVID. She described it as one of the mildest illnesses she's ever had, though her senses of taste and smell have not returned to normal. Watermelon tastes rotten to her, beer tasted like Windex for a while, and her daughter said Sondgeroth can't smell certain flowers anymore.
Sondgeroth said she's holding off on getting vaccinated until more research comes out.
Waiting in line at the daiquiri stand, Alicia Nix was one of the few people in sight wearing a mask. "I've gotten people that say, you know, 'That stuff is over. Get over yourself and take that off,'" said Nix, who is vaccinated. "It isn't over."
Amid the music, beer and dancing, a bus turned into a mobile vaccine clinic was empty. A nurse on duty played Jenga with an Army National Guard soldier. Just six people of the thousands attending were vaccinated on the bus.
"You can lead a horse to water, but you can't make them drink," Nix said from behind her blue surgical mask.