Today, Friday, April 26, Secretary Becerra released the following statement.

The press release announces 12 winners in the first phase of the $1 million Environmental Justice Community Innovator Challenge.

The Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) issued a final rule under Section 1557 of the Affordable Care Act (ACA)

In the 2020 elections, then-candidate Joe Biden and many of his congressional colleagues loudly advocated for a federal “public option” health insurance plan. It was framed, at the time, as part of his incoming administration’s response to the pandemic.

“Low-income Americans will be automatically enrolled in the public option at zero cost to them, though they may choose to opt out at any time,” Democrats promised in their party platform.

But since Biden entered office, it’s been crickets. The president hasn’t uttered the phrase “public option” since December 2020, according to factba.se, which tracks his public remarks.

Why the disappearing act? In a word: politics.

“Out of the gate you’d have a huge powerful lobby against the public option — the hospitals — since providers have the most to lose: lots of money,” said Matthew Fiedler, an economist at the Brookings Institution who has studied payment disparities between insurance plans. The health-care industry is the largest lobbying sector in Washington, with more than $132 million spent annually just by hospitals and nursing homes, according to OpenSecrets.

For those who’ve forgotten, the idea was to create a government-sponsored insurance plan to compete with commercial insurers under the Affordable Care Act. The concept, previously backed by President Barack Obama, didn’t make it into the final version of the ACA due to opposition from pretty much everyone in health care.

In theory, a public option structured like Medicare, Medicaid or the military’s Tricare program could save billions in health-care spending by both the federal government and consumers because (like the existing federal plans) it would pay health providers less than commercial insurers. Fiedler said the public option could possibly save money, relative to commercial insurance, even if it paid as much as double Medicare’s rates.

And without having to earn a profit, such a plan could spend more money on patient care.

Unsurprisingly, insurers opposed the public option, but Fiedler said it’s hospital opposition that keeps it shelved.

As an example, Fiedler points to Medicare drug price negotiation, another long shot Democratic priority. Biden got that across the finish line as part of his 2022 Inflation Reduction Act.

“Congress didn’t want to pick a fight with hospitals, but they’re willing to take on drug companies,” Fiedler said.

Biden’s party hasn’t yet put together its official platform for the 2024 election, so perhaps the public option will reappear on his agenda. Spokespeople for his reelection campaign and the White House didn’t respond to emailed questions about it.

The idea still has many fans: Led by Colorado, some states have sought to create their own versions, though their plans rely on commercial insurers to administer the coverage. Insurers were able to tank public option proposals in Connecticut, and they’ve complained that they would lose money under Colorado’s proposal.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

Private Medicaid health plans lost millions of members in the past year as pandemic protections that prohibited states from dropping anyone from the government program expired.

But despite Medicaid’s unwinding, as it’s known, at least two of the five largest publicly traded companies selling plans have continued to increase revenue from the program, according to their latest earnings reports.

“It’s a very interesting paradox,” said Andy Schneider, a research professor at Georgetown University’s McCourt School of Public Policy, of plans’ Medicaid revenue increasing despite enrollment drops.

Medicaid, the state-federal health program for low-income and disabled people, is administered by states. But most people enrolled in the program get their health care through insurers contracted by states, including UnitedHealthcare, Centene, and Molina.

The companies persuaded states to pay them more money per Medicaid enrollee under the assumption that younger and healthier people were dropping out — presumably for Obamacare coverage or employer-based health insurance, or because they didn’t see the need to get coverage — leaving behind an older and sicker population to cover, their executives have told investors.

Several of the companies reported that states have made midyear and retrospective changes in their payments to plans to account for the worsening health status of members.

In an earnings call with analysts on April 25, Molina Healthcare CEO Joe Zubretsky said 19 states increased their payment rates this year to adjust for sicker Medicaid enrollees. “States have been very responsive,” Zubretsky said. “We couldn’t be more pleased with the way our state customers have responded to having rates be commensurate with normal cost trends and trends that have been influenced by the acuity shift.”

Health plans have faced much uncertainty during the Medicaid unwinding, as states began reassessing enrollees’ eligibility and dropping those deemed no longer qualified or who lost coverage because of procedural errors. Before the unwinding, plans said they expected the overall risk profile of their members to go up because those remaining in the program would be sicker.

UnitedHealthcare, Centene, and Molina had Medicaid revenue increases ranging from 3% to 18% in 2023, according to KFF. The two other large Medicaid insurers, Elevance and CVS Health, do not break out Medicaid-specific revenue.

The Medicaid enrollment of the five companies collectively declined by about 10% from the end of March 2023 through the end of December 2023, from 44.2 million people to 39.9 million, KFF data shows.

In the first quarter of 2024, UnitedHealth’s Medicaid revenue rose to $20.5 billion, up from $18.8 billion in the same quarter of 2023.

Molina on April 24 reported nearly $7.5 billion in Medicaid revenue in the first quarter of 2024, up from $6.3 billion in the same quarter a year earlier.

On April 26, Centene reported that its Medicaid enrollment fell 18.5% to 13.3 million in the first quarter of 2024 compared with the same period a year ago. The company’s Medicaid revenue dipped 3% to $22.2 billion.

Unlike UnitedHealthcare, whose Medicaid enrollment fell to 7.7 million in March 2024 from 8.4 million a year prior, Molina’s Medicaid enrollment rose in the first quarter of 2024 to 5.1 million from 4.8 million in March 2023. Molina’s enrollment jump last year was partly a result of its having bought a Medicaid plan in Wisconsin and gained a new Medicaid contract in Iowa, the company said in its earnings news release.

Molina added 1 million members because states were prohibited from terminating Medicaid coverage during the pandemic. The company has lost 550,000 of those people during the unwinding and expects to lose an additional 50,000 by June.

About 90% of Molina Medicaid members have gone through the redetermination process, Zubretsky said.

The corporate giants also offset the enrollment losses by getting more Medicaid money from states, which they use to pass on higher payments to certain facilities or providers, Schneider said. By holding the money temporarily, the companies can count these “directed payments” as revenue.

Medicaid health plans were big winners during the pandemic after the federal government prohibited states from dropping people from the program, leading to a surge in enrollment to about 93 million Americans.

States made efforts to limit health plans’ profits by clawing back some payments above certain thresholds, said Elizabeth Hinton, an associate director at KFF.

But once the prohibition on dropping Medicaid enrollees was lifted last spring, the plans faced uncertainty. It was unclear how many people would lose coverage or when it would happen. Since the unwinding began, more than 20 million people have been dropped from the rolls.

Medicaid enrollees’ health care costs were lower during the pandemic, and some states decided to exclude pandemic-era cost data as they considered how to set payment rates for 2024. That provided yet another win for the Medicaid health plans.

Most states are expected to complete their Medicaid unwinding processes this year.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

With little pomp, California launched two apps at the start of the year offering free behavioral health services to youths to help them cope with everything from living with anxiety to body acceptance.

Through their phones, young people and some caregivers can meet BrightLife Kids and Soluna coaches, some who specialize in peer support or substance use disorders, for roughly 30-minute virtual counseling sessions that are best suited to those with more mild needs, typically those without a clinical diagnosis. The apps also feature self-directed activities, such as white noise sessions, guided breathing, and videos of ocean waves to help users relax.

“We believe they’re going to have not just great impact, but wide impact across California, especially in places where maybe it’s not so easy to find an in-person behavioral health visit or the kind of coaching and supports that parents and young people need,” said Gov. Gavin Newsom’s health secretary, Mark Ghaly, during the Jan. 16 announcement.

The apps represent one of the Democratic governor’s major forays into health technology and come with four-year contracts valued at $498 million. California is believed to be the first state to offer a mental health app with free coaching to all young residents, according to the Department of Health Care Services, which operates the program.

However, the rollout has been slow. So slow that one of the companies has missed a deadline to make its app available on Android phones. Only about 15,000 of the state’s 12.6 million children and young adults have signed up for the apps, and school counselors say they’ve never heard of them.

Advocates for youth question the wisdom of investing taxpayer dollars in two private companies. Social workers are concerned the companies’ coaches won’t properly identify youths who need referrals for clinical care. And the spending is drawing lawmaker scrutiny amid a state deficit pegged at as much as $73 billion.

An App for That

Newsom’s administration says the apps fill a need for young Californians and their families to access professional telehealth for free, in multiple languages, and outside of standard 9-to-5 hours. It’s part of Newsom’s sweeping $4.7 billion master plan for kids’ mental health, which was introduced in 2022 to increase access to mental health and substance use support services. In addition to launching virtual tools such as the teletherapy apps, the initiative is working to expand workforce capacity, especially in underserved areas.

“The reality is that we are rarely 6 feet away from our devices,” said Sohil Sud, director of Newsom’s Children and Youth Behavioral Health Initiative. “The question is how we can leverage technology as a resource for all California youth and families, not in place of, but in addition to, other behavioral health services that are being developed and expanded.”

The virtual platforms come amid rising depression and suicide rates among youth and a shortage of mental health providers. Nearly half of California youths from the ages of 12 to 17 report having recently struggled with mental health issues, with nearly a third experiencing serious psychological distress, according to a 2021 study by the UCLA Center for Health Policy Research. These rates are even higher for multiracial youths and those from low-income families.

But those supporting youth mental health at the local level question whether the apps will move the needle on climbing depression and suicide rates.

“It’s fair to applaud the state of California for aggressively seeking new tools,” said Alex Briscoe of California Children’s Trust, a statewide initiative that, along with more than 100 local partners, works to improve the social and emotional health of children. “We just don’t see it as fundamental. And we don’t believe the youth mental health crisis will be solved by technology projects built by a professional class who don’t share the lived experience of marginalized communities.”

The apps, BrightLife Kids and Soluna, are operated by two companies: Brightline, a 5-year-old venture capital-backed startup; and Kooth, a London-based publicly traded company that has experience in the U.K. and has also signed on some schools in Kentucky and Pennsylvania and a health plan in Illinois. In the first five months of Kooth’s Pennsylvania pilot, 6% of students who had access to the app signed up.

Brightline and Kooth represent a growing number of health tech firms seeking to profit in this space. They beat out dozens of other bidders including international consulting companies and other youth telehealth platforms that had already snapped up contracts in California.

Although the service is intended to be free with no insurance requirement, Brightline’s app, BrightLife Kids, is folded into and only accessible through the company’s main app, which asks for insurance information and directs users to paid licensed counseling options alongside the free coaching. After KFF Health News questioned why the free coaching was advertised below paid options, Brightline reordered the page so that, even if a child has high-acuity needs, free coaching shows up first.

The apps take an expansive view of behavioral health, making the tools available to all California youth under age 26 as well as caregivers of babies, toddlers, and children 12 and under. When KFF Health News asked to speak with an app user, Brightline connected a reporter with a mother whose 3-year-old daughter was learning to sleep on her own.

‘It’s Like Crickets’

Despite being months into the launch and having millions in marketing funds, the companies don’t have a definitive rollout timeline. Brightline said it hopes to have deployed teams across the state to present the tools in person by midyear. Kooth said developing a strategy to hit every school would be “the main focus for this calendar year.”

“It’s a big state — 58 counties,” Bob McCullough of Kooth said. “It’ll take us a while to get to all of them.”

Brightline’s contract states that the company was required to launch downloadable apps for iOS and Android phones by January, but so far BrightLife Kids is available only on Apple phones. Brightline said it’s aiming to launch the Android version over the summer.

“Nobody’s really done anything like this at this magnitude, I think, in the U.S. before,” said Naomi Allen, a co-founder and the CEO of Brightline. “We’re very much in the early innings. We’re already learning a lot.”

The contracts, obtained by KFF Health News through a records request, show the companies operating the two apps could earn as much as $498 million through the contract term, which ends in June 2027, months after Newsom is set to leave office. And the state is spending hundreds of millions more on Newsom’s virtual behavioral health strategy. The state said it aims to make the apps available long-term, depending on usage.

The state said 15,000 people signed up in the first three months. When KFF Health News asked how many of those users actively engaged with the app, it declined to say, noting that data would be released this summer.

KFF Health News reached out to nearly a dozen California mental health professionals and youths. None of them were aware of the apps.

“I’m not hearing anything,” said Loretta Whitson, executive director of the California Association of School Counselors. “It’s like crickets.”

Whitson said she doesn’t think the apps are on “anyone’s” radar in schools, and she doesn’t know of any schools that are actively advertising them. Brightline will be presenting its tool to the counselor association in May, but Whitson said the company didn’t reach out to plan the meeting; she did.

Concern Over Referrals

Whitson isn’t comfortable promoting the apps just yet. Although both companies said they have a clinical team on staff to assist, Whitson said she’s concerned that the coaches, who aren’t all licensed therapists, won’t have the training to detect when users need more help and refer them to clinical care.

This sentiment was echoed by other school-based social workers, who also noted the apps’ duplicative nature — in some counties, like Los Angeles, youths can access free virtual counseling sessions through Hazel Health, a for-profit company. Nonprofits, too, have entered this space. For example, Teen Line, a peer-to-peer hotline operated by Southern California-based Didi Hirsch Mental Health Services, is free nationwide.

While the state is also funneling money to the schools as part of Newsom’s master plan, students and school-based mental health professionals voiced confusion at the large app investment when, in many school districts, few in-person counseling roles exist, and in some cases are dwindling.

Kelly Merchant, a student at College of the Desert in Palm Desert, noted that it can be hard to access in-person therapy at her school. She believes the community college, which has about 15,000 students, has only one full-time counselor and one part-time bilingual counselor. She and several students interviewed by KFF Health News said they appreciated having engaging content on their phone and the ability to speak to a coach, but all said they’d prefer in-person therapy.

“There are a lot of people who are seeking therapy, and people close to me that I know. But their insurances are taking forever, and they’re on the waitlist,” Merchant said. “And, like, you’re seeing all these people struggle.”

Fiscal conservatives question whether the money could be spent more effectively, like to bolster county efforts and existing youth behavioral health programs.

Republican state Sen. Roger Niello, vice chair of the Senate Budget and Fiscal Review Committee, noted that California is forecasted to face deficits for the next three years, and taxpayer watchdogs worry the apps might cost even more in the long run.

“What starts as a small financial commitment can become uncontrollable expenses down the road,” said Susan Shelley of the Howard Jarvis Taxpayers Association.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

HHS announced today that 20 states have been selected to participate in two technical assistance programs.

The Biden administration wants to make it easier for Americans to get dental care. But don’t try booking an appointment just yet.

A new regulation out this month allows states to include adult dental care as a benefit that health insurers must cover under the Affordable Care Act. Following record ACA enrollment this year, the proposal represents an election-year aspiration for the future of Obamacare: It doesn’t require states to do anything, even as it shows off President Biden’s intention to make the ACA a more robust safety net.

“It’s huge, really significant,” said Colin Reusch, director of policy at Community Catalyst, a health coverage advocacy group. He said the new Biden administration rule represents “one of the first real changes” to coverage provisions of the law since it passed in 2010.

But like so much in health care, expanding access to dental services is a lot more complicated than it sounds.

An estimated 68.5 million U.S. adults lacked dental insurance in 2023, according to the nonprofit CareQuest Institute for Oral Health. That’s more than 2.5 times the roughly 26 million Americans of all ages who lack health insurance.

And millions of Americans lost dental coverage in the past year as part of the Medicaid “unwinding” that dropped low-income people who had been covered by the program during the pandemic.

At the same time, untreated dental disease is estimated to cost the United States more than $45 billion in lost productivity annually, according to the Centers for Disease Control and Prevention, and it’s linked to a long list of even more serious health problems, including heart disease and diabetes.

Still, efforts to expand U.S. dental coverage have long foundered on the shoals of cost. When people have dental insurance, they tend to use it. So including the coverage in a health insurance policy can raise overall premiums.

That’s one reason traditional Medicare coverage explicitly excludes most dental care. (Many private Medicare Advantage plans offer some dental coverage as an enticement for seniors to join.)

An effort to add a dental benefit to Medicare was stripped from Biden’s “Build Back Better” legislation before it was passed in 2022 as the Inflation Reduction Act. Instead, the administration clarified and expanded the limited circumstances in which Medicare can cover dental care. Any progress on oral health — including giving states the option to require coverage for adults — is seen by advocates as a victory. Dental coverage for children is already an essential benefit under the ACA.

But whether they actually get coverage depends on states affirmatively adding dental benefits to benchmark plans in the ACA’s insurance marketplaces. Those plans not only determine what services Affordable Care Act insurance has to cover, but also set parameters for state-employee and many private-employer health plans.

Reusch said a few states are considering the change, but it will be a while until anything is certain. States have until May 2025 to decide whether to add dental care to benchmark ACA plans; the benefit wouldn’t be effective until the 2027 plan year.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

More than 60 years ago, policymakers in Colorado embraced the idea that early intervention could prevent child abuse and save lives. The state’s requirement that certain professionals tell officials when they suspect a child has been abused or neglected was among the first mandatory reporting laws in the nation.

Since then, mandatory reporting laws have expanded nationally to include more types of maltreatment — including neglect, which now accounts for most reports — and have increased the number of professions required to report. In some states, all adults are required to report what they suspect may be abuse or neglect.

But now there are efforts in Colorado and other states to roll back these laws, saying the result has been too many unfounded reports, and that they disproportionately harm families that are poor, Black, or Indigenous, or have members with disabilities.

“There’s a long, depressing history based on the approach that our primary response to a struggling family is reporting,” said Mical Raz, a physician and historian at the University of Rochester in New York. “There’s now a wealth of evidence that demonstrates that more reporting is not associated with better outcomes for children.”

Stephanie Villafuerte, Colorado’s child protection ombudsman, oversees a task force to reexamine the state’s mandatory reporting laws. She said the group is seeking to balance a need to report legitimate cases of abuse and neglect with a desire to weed out inappropriate reports.

“This is designed to help individuals who are disproportionately impacted,” Villafuerte said. “I’m hoping it’s the combination of these efforts that could make a difference.”

Some critics worry that changes to the law could result in missed cases of abuse. Medical and child care workers on the task force have expressed concern about legal liability. While it’s rare for people to be criminally charged for failure to report, they can also face civil liability or professional repercussions, including threats to their licenses.

Being reported to child protective services is becoming increasingly common. More than 1 in 3 children in the United States will be the subject of a child abuse and neglect investigation by the time they turn 18, according to the most frequently cited estimate, a 2017 study funded by the Department of Health and Human Services’ Children’s Bureau.

Black and Native American families, poor families, and parents or children with disabilities experience even more oversight. Research has found that, among these groups, parents are more likely to lose parental rights and children are more likely to wind up in foster care.

In an overwhelming majority of investigations, no abuse or neglect is substantiated. Nonetheless, researchers who study how these investigations affect families describe them as terrifying and isolating.

In Colorado, the number of child abuse and neglect reports has increased 42% in the past decade and reached a record 117,762 last year, according to state data. Roughly 100,000 other calls to the hotline weren’t counted as reports because they were requests for information or were about matters like child support or adult protection, said officials from the Colorado Department of Human Services.

The increase in reports can be traced to a policy of encouraging a broad array of professionals — including school and medical staff, therapists, coaches, clergy members, firefighters, veterinarians, dentists, and social workers — to call a hotline whenever they have a concern.

These calls don’t reflect a surge in mistreatment. More than two-thirds of the reports received by agencies in Colorado don’t meet the threshold for investigation. Of the children whose cases are assessed, 21% are found to have experienced abuse or neglect. The actual number of substantiated cases has not risen over the past decade.

While studies do not demonstrate that mandatory reporting laws keep children safe, the Colorado task force reported in January, there is evidence of harm. “Mandatory reporting disproportionately impacts families of color” — initiating contact between child protection services and families who routinely do not present concerns of abuse or neglect, the task force said.

The task force said it is analyzing whether better screening might mitigate “the disproportionate impact of mandatory reporting on under-resourced communities, communities of color and persons with disabilities.”

The task force pointed out that the only way to report concerns about a child is with a formal report to a hotline. Yet many of those calls are not to report abuse at all but rather attempts to connect children and families with resources like food or housing assistance.

Hotline callers may mean to help, but the families who are the subjects of mistaken reports of abuse and neglect rarely see it that way.

That includes Meighen Lovelace, a rural Colorado resident who asked KFF Health News not to disclose their hometown for fear of attracting unwanted attention from local officials. For Lovelace’s daughter, who is neurodivergent and has physical disabilities, the reports started when she entered preschool at age 4 in 2015. The teachers and medical providers making the reports frequently suggested that the county human services agency could assist Lovelace’s family. But the investigations that followed were invasive and traumatic.

“Our biggest looming fear is, ‘Are you going to take our children away?’” said Lovelace, who is an advocate for the Colorado Cross-Disability Coalition, an organization that lobbies for the civil rights of people with disabilities. “We’re afraid to ask for help. It’s keeping us from entering services because of the fear of child welfare.”

State and county human services officials said they could not comment on specific cases.

The Colorado task force plans to suggest clarifying the definitions of abuse and neglect under the state’s mandatory reporting statute. Mandatory reporters should not “make a report solely due to a family/child’s race, class or gender,” nor because of inadequate housing, furnishings, income or clothing. Also, there should not be a report based solely on the “disability status of the minor, parent or guardian,” according to the group’s draft recommendation.

The task force plans to recommend additional training for mandatory reporters, help for professionals who are deciding whether to make a call, and an alternative phone number, or “warmline,” for cases in which callers believe a family needs material assistance, rather than surveillance.

Critics say such changes could leave more children vulnerable to unreported abuse.

“I’m concerned about adding systems such as the warmline, that kids who are in real danger are going to slip through the cracks and not be helped,” said Hollynd Hoskins, an attorney who represents victims of child abuse. Hoskins has sued professionals who fail to report their suspicions.

The Colorado task force includes health and education officials, prosecutors, victim advocates, county child welfare representatives and attorneys, as well as five people who have experience in the child welfare system. It intends to finalize its recommendations by early next year in the hope that state legislators will consider policy changes in 2025. Implementation of any new laws could take several years.

Colorado is one of several states — including New York and California — that have recently considered changes to restrain, rather than expand, reporting of abuse. In New York City, teachers are being trained to think twice before making a report, while New York state introduced a warmline to help connect families with resources like housing and child care. In California, a state task force aimed at shifting “mandated reporting to community supporting” is planning recommendations similar to Colorado’s.

Among those advocating for change are people with experience in the child welfare system. They include Maleeka Jihad, who leads the Denver-based MJCF Coalition, which advocates for the abolition of mandatory reporting along with the rest of the child welfare system, citing its damage to Black, Native American, and Latino communities.

“Mandatory reporting is another form of keeping us policed and surveillanced by whiteness,” said Jihad, who as a child was taken from the care of a loving parent and placed temporarily into the foster system. Reform isn’t enough, she said. “We know what we need, and it’s usually funding and resources.”

Some of these resources — like affordable housing and child care — don’t exist at a level sufficient for all the Colorado families that need them, Jihad said.

Other services are out there, but it’s a matter of finding them. Lovelace said the reports ebbed after the family got the help it needed, in the form of a Medicaid waiver that paid for specialized care for their daughter’s disabilities. Their daughter is now in seventh grade and doing well.

None of the caseworkers who visited the family ever mentioned the waiver, Lovelace said. “I really think they didn’t know about it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

CHARLESTON, S.C. — When he recently walked into the dental clinic at the Medical University of South Carolina donning a bright-blue pullover with “In Our DNA SC” embroidered prominently on the front, Lee Moultrie said, two Black women stopped him to ask questions.

“It’s a walking billboard,” said Moultrie, a health care advocate who serves on the community advisory board for In Our DNA SC, a study underway at the university that aims to enroll 100,000 South Carolinians — including a representative percentage of Black people — in genetics research. The goal is to better understand how genes affect health risks such as cancer and heart disease.

Moultrie, who is Black and has participated in the research project himself, used the opportunity at the dental clinic to encourage the women to sign up and contribute their DNA. He keeps brochures about the study in his car and at the barbershop he visits weekly for this reason. It’s one way he wants to help solve a problem that has plagued the field of genetics research for decades: The data is based mostly on DNA from white people.

Project leaders in Charleston told KFF Health News in 2022 that they hoped to enroll participants who reflect the demographic diversity of South Carolina, where just under 27% of residents identify as Black or African American. To date, though, they’ve failed to hit that mark. Only about 12% of the project’s participants who provided sociodemographic data identify as Black, while an additional 5% have identified as belonging to another racial minority group.

“We’d like to be a lot more diverse,” acknowledged Daniel Judge, principal investigator for the study and a cardiovascular genetics specialist at the Medical University of South Carolina.

Lack of diversity in genetics research has real health care implications. Since the completion more than 20 years ago of the Human Genome Project, which mapped most human genes for the first time, close to 90% of genomics studies have been conducted using DNA from participants of European descent, research shows. And while human beings of all races and ancestries are more than 99% genetically identical, even small differences in genes can spell big differences in health outcomes.

“Precision medicine” is a term used to describe how genetics can improve the way diseases are diagnosed and treated by considering a person’s DNA, environment, and lifestyle. But if this emerging field of health care is based on research involving mostly white people, “it could lead to mistakes, unknowingly,” said Misa Graff, an associate professor in epidemiology at the University of North Carolina and a genetics researcher.

In fact, that’s already happening. In 2016, for example, research found that some Black patients had been misdiagnosed with a potentially fatal heart condition because they’d tested positive for a genetic variant thought to be harmful. That variant is much more common among Black Americans than white Americans, the research found, and is considered likely harmless among Black people. Misclassifications can be avoided if “even modest numbers of people from diverse populations are included in sequence databases,” the authors wrote.

The genetics research project in Charleston requires participants to complete an online consent form and submit a saliva sample, either in person at a designated lab or collection event or by mail. They are not paid to participate, but they do receive a report outlining their DNA results. Those who test positive for a genetic marker linked to cancer or high cholesterol are offered a virtual appointment with a genetics counselor free of charge.

Some research projects require more time from their volunteers, which can skew the pool of participants, Graff said, because not everyone has the luxury of free time. “We need to be even more creative in how we obtain people to help contribute to studies,” she said.

Moultrie said he recently asked project leaders to reach out to African American media outlets throughout the Palmetto State to explain how the genetics research project works and to encourage Black people to participate. He also suggested that when researchers talk to Black community leaders, such as church pastors, they ought to persuade those leaders to enroll in the study instead of simply passing the message along to their congregations.

“We have new ideas. We have ways we can do this,” Moultrie said. “We’ll get there.”

Other ongoing efforts are already improving diversity in genetics research. At the National Institutes of Health, a program called “All of Us” aims to analyze the DNA of more than 1 million people across the country to build a diverse health database. So far, that program has enrolled more than 790,000 participants. Of these, more than 560,000 have provided DNA samples and about 45% identify as being part of a racial or ethnic minority group.

“Diversity is so important,” said Karriem Watson, chief engagement officer for the All of Us research program. “When you think about groups that carry the greatest burden of disease, we know that those groups are often from minoritized populations.”

Diverse participation in All of Us hasn’t come about by accident. NIH researchers strategically partnered with community health centers, faith-based groups, and Black fraternities and sororities to recruit people who have been historically underrepresented in biomedical research.

In South Carolina, for example, the NIH works with Cooperative Health, a network of federally qualified health centers near the state capital that serve many patients who are uninsured and Black, to recruit patients for All of Us. Eric Schlueter, chief medical officer of Cooperative Health, said the partnership works because their patients trust them.

“We have a strong history of being integrated into the community. Many of our employees grew up and still live in the same communities that we serve,” Schlueter said. “That is what is part of our secret sauce.”

So far, Cooperative Health has enrolled almost 3,000 people in the research program, about 70% of whom are Black.

“Our patients are just like other patients,” Schlueter said. “They want to be able to provide an opportunity for their children and their children’s children to have better health, and they realize this is an opportunity to do that.”

Theoretically, researchers at the NIH and the Medical University of South Carolina may be trying to recruit some of the same people for their separate genetics studies, although nothing would prevent a patient from participating in both efforts.

The researchers in Charleston acknowledge they still have work to do. To date, In Our DNA SC has recruited about half of the 100,000 people it hopes for, and of those, about three-quarters have submitted DNA samples.

Caitlin Allen, a program investigator and a public health researcher at the medical university, acknowledged that some of the program’s tactics haven’t succeeded in recruiting many Black participants.

For example, some patients scheduled to see providers at the Medical University of South Carolina receive an electronic message through their patient portal before an appointment, which includes information about participating in the research project. But studies show that racial and ethnic minorities are less likely to engage with their electronic health records than white patients, Allen said.

“We see low uptake” with that strategy, she said, because many of the people researchers are trying to engage likely aren’t receiving the message.

The study involves four research coordinators trained to take DNA samples, but there’s a limit to how many people they can talk to face-to-face. “We’re not necessarily able to go into every single room,” Allen said.

That said, in-person community events seem to work well for enrolling diverse participants. In March, In Our DNA SC research coordinators collected more than 30 DNA samples at a bicentennial event in Orangeburg, South Carolina, where more than 60% of residents identify as Black. Between the first and second year of the research project, Allen said, In Our DNA SC doubled the number of these community events that research coordinators attended.

“I would love to see it ramp up even more,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

Some justices suggested the Supreme Court had said its piece on abortion law when it overturned Roe v. Wade in 2022. This term, however, the court has agreed to review another abortion case. At issue is whether a federal law requiring emergency care in hospitals overrides Idaho’s near-total abortion ban. A decision is expected by summer.

Meanwhile, the Centers for Medicare & Medicaid finalized the first-ever minimum staffing requirements for nursing homes participating in the programs. But the industry argues that there are not enough workers to hire to meet the standards.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins University’s nursing and public health schools and Politico Magazine, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

Panelists Joanne Kenen Johns Hopkins University and Politico @JoanneKenen Read Joanne's articles. Tami Luhby CNN @Luhby Read Tami's stories. Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories.

Among the takeaways from this week’s episode:

• This week’s Supreme Court hearing on emergency abortion care in Idaho was the first challenge to a state’s abortion ban since the overturn of the constitutional right to an abortion. Unlike previous abortion cases, this one focused on the everyday impacts of bans on abortion care — cases in which pregnant patients experienced medical emergencies.
• Establishment medical groups and doctors themselves are getting more vocal and active as states set laws on abortion access. In a departure from earlier political moments, some major medical groups are campaigning on state ballot measures.
• Medicaid officials this week finalized new rules intended to more closely regulate managed-care plans that enroll Medicaid patients. The rules are intended to ensure, among other things, that patients have prompt access to needed primary care doctors and specialists.
• Also this week, the Federal Trade Commission voted to ban most “noncompete” clauses in employment contracts. Such language has become common in health care and prevents not just doctors but other health workers from changing jobs — often forcing those workers to move or commute to leave a position. Business interests are already suing to block the new rules, claiming they would be too expensive and risk the loss of proprietary information to competitors.
• The fallout from the cyberattack of Change Healthcare continues, as yet another group is demanding ransom from UnitedHealth Group, Change’s owner. UnitedHealth said in a statement this week that the records of “a substantial portion of America” may be involved in the breach.

Plus for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: NBC News’ “Women Are Less Likely To Die When Treated by Female Doctors, Study Suggests,” by Liz Szabo.  

Alice Miranda Ollstein: States Newsroom’s “Loss of Federal Protection in Idaho Spurs Pregnant Patients To Plan for Emergency Air Transport,” by Kelcie Moseley-Morris.  

Tami Luhby: The Associated Press’ “Mississippi Lawmakers Haggle Over Possible Medicaid Expansion as Their Legislative Session Nears End,” by Emily Wagster Pettus.  

Joanne Kenen: States Newsroom’s “Missouri Prison Agency To Pay $60K for Sunshine Law Violations Over Inmate Death Records,” by Rudi Keller.  

Also mentioned on this week’s podcast:

• American Economic Review’s “Is There Too Little Antitrust Enforcement in the U.S. Hospital Sector?” by Zarek Brot-Goldberg, Zack Cooper, Stuart Craig, and Lev Klarnet.
• KFF Health News’ “Medical Providers Still Grappling With UnitedHealth Cyberattack: ‘More Devastating Than Covid,” by Samantha Liss.

Credits Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

Joint Theme for 2024 Asian American, Native Hawaiian, and Pacific Islander Heritage Month

Nearly a decade ago, Medicare launched a program to help the two-thirds of beneficiaries with chronic conditions by paying their doctors an additional monthly fee to coordinate their care.

The strategy has largely failed to live up to its potential; only about 4 percent of potentially eligible beneficiaries in the traditional Medicare program are enrolled, according to a Mathematica analysis.

But thousands of physicians have boosted their pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. An analysis of federal data by my KFF Health News colleague Holly K. Hacker shows that about 4,500 physicians received at least $100,000 each in chronic care management pay in 2021.

“This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy professor and an expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

Centers for Medicare and Medicaid Services spokespeople didn’t respond to questions about the program’s low participation rate, and it’s not clear whether the agency will address the issue.

Under the CCM program, Medicare pays physicians to develop a patient care plan, coordinate treatment with specialists and regularly check in with beneficiaries. Doctors receive an average of $62 per patient per month for at least 20 minutes of work, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care for their patients because they can’t bill Medicare for the work.

A host of factors limit participation in the program, according to Thorpe and other experts. Chief among them is that both doctors and patients must opt into participating.

Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly co-payment, if they don’t have a supplemental policy.

“This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

There’s evidence that wider uptake could generate savings ― as well as happier patients. A federally funded study by Mathematica in 2017 found the CCM program saved Medicare about $888 per patient per year ― owing mostly to decreasing hospital care.

Carrie Lester, 73, looks forward to a phone call every Thursday from her doctors’ medical assistant, who asks how she’s doing and if she needs prescription refills. The assistant counsels her on dealing with anxiety and other health issues.

Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, who lives with her dogs, Sophie and Dolly, in Independence, Kan.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

For decades, concerns about automobile pollution have focused on what comes out of the tailpipe. Now, researchers and regulators say, we need to pay more attention to toxic emissions from tires as vehicles roll down the road.

At the top of the list of worries is a chemical called 6PPD, which is added to rubber tires to help them last longer. When tires wear on pavement, 6PPD is released. It reacts with ozone to become a different chemical, 6PPD-q, which can be extremely toxic — so much so that it has been linked to repeated fish kills in Washington state.

The trouble with tires doesn’t stop there. Tires are made primarily of natural rubber and synthetic rubber, but they contain hundreds of other ingredients, often including steel and heavy metals such as copper, lead, cadmium, and zinc.

As car tires wear, the rubber disappears in particles, both bits that can be seen with the naked eye and microparticles. Testing by a British company, Emissions Analytics, found that a car’s tires emit 1 trillion ultrafine particles per kilometer driven — from 5 to 9 pounds of rubber per internal combustion car per year.

And what’s in those particles is a mystery, because tire ingredients are proprietary.

“You’ve got a chemical cocktail in these tires that no one really understands and is kept highly confidential by the tire manufacturers,” said Nick Molden, CEO of Emissions Analytics. “We struggle to think of another consumer product that is so prevalent in the world and used by virtually everyone, where there is so little known of what is in them.”

Regulators have only begun to address the toxic tire problem, though there has been some action on 6PPD.

The chemical was identified by a team of researchers, led by scientists at Washington State University and the University of Washington, who were trying to determine why coho salmon returning to Seattle-area creeks to spawn were dying in large numbers.

Working for the Washington Stormwater Center, the scientists tested some 2,000 substances to determine which one was causing the die-offs, and in 2020 they announced they’d found the culprit: 6PPD.

The Yurok Tribe in Northern California, along with two other West Coast Native American tribes, have petitioned the Environmental Protection Agency to prohibit the chemical. The EPA said it is considering new rules governing the chemical. “We could not sit idle while 6PPD kills the fish that sustain us,” said Joseph L. James, chairman of the Yurok Tribe, in a statement. “This lethal toxin has no place in any salmon-bearing watershed.”

California has begun taking steps to regulate the chemical, last year classifying tires containing it as a “priority product,” which requires manufacturers to search for and test substitutes.

“6PPD plays a crucial role in the safety of tires on California’s roads and, currently, there are no widely available safer alternatives,” said Karl Palmer, a deputy director at the state’s Department of Toxic Substances Control. “For this reason, our framework is ideally suited for identifying alternatives to 6PPD that ensure the continued safety of tires on California’s roads while protecting California’s fish populations and the communities that rely on them.”

The U.S. Tire Manufacturers Association says it has mobilized a consortium of 16 tire manufacturers to carry out an analysis of alternatives. Anne Forristall Luke, USTMA president and CEO, said it “will yield the most effective and exhaustive review possible of whether a safer alternative to 6PPD in tires currently exists.”

Molden, however, said there is a catch. “If they don’t investigate, they aren’t allowed to sell in the state of California,” he said. “If they investigate and don’t find an alternative, they can go on selling. They don’t have to find a substitute. And today there is no alternative to 6PPD.”

California is also studying a request by the California Stormwater Quality Association to classify tires containing zinc, a heavy metal, as a priority product, requiring manufacturers to search for an alternative. Zinc is used in the vulcanization process to increase the strength of the rubber.

When it comes to tire particles, though, there hasn’t been any action, even as the problem worsens with the proliferation of electric cars. Because of their quicker acceleration and greater torque, electric vehicles wear out tires faster and emit an estimated 20% more tire particles than the average gas-powered car.

A recent study in Southern California found tire and brake emissions in Anaheim accounted for 30% of PM2.5, a small-particulate air pollutant, while exhaust emissions accounted for 19%. Tests by Emissions Analytics have found that tires produce up to 2,000 times as much particle pollution by mass as tailpipes.

These particles end up in water and air and are often ingested. Ultrafine particles, even smaller than PM2.5, are also emitted by tires and can be inhaled and travel directly to the brain. New research suggests tire microparticles should be classified as a pollutant of “high concern.”

In a report issued last year, researchers at Imperial College London said the particles could affect the heart, lungs, and reproductive organs and cause cancer.

People who live or work along roadways, often low-income, are exposed to more of the toxic substances.

Tires are also a major source of microplastics. More than three-quarters of microplastics entering the ocean come from the synthetic rubber in tires, according to a report from the Pew Charitable Trusts and the British company Systemiq.

And there are still a great many unknowns in tire emissions, which can be especially complex to analyze because heat and pressure can transform tire ingredients into other compounds.

One outstanding research question is whether 6PPD-q affects people, and what health problems, if any, it could cause. A recent study published in Environmental Science & Technology Letters found high levels of the chemical in urine samples from a region of South China, with levels highest in pregnant women.

The discovery of 6PPD-q, Molden said, has sparked fresh interest in the health and environmental impacts of tires, and he expects an abundance of new research in the coming years. “The jigsaw pieces are coming together,” he said. “But it’s a thousand-piece jigsaw, not a 200-piece jigsaw.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

Durante décadas, las preocupaciones sobre la contaminación automovilística se han centrado en lo que sale del tubo de escape. Ahora, investigadores y reguladores dicen que se necesita prestar más atención a las emisiones tóxicas de los neumáticos mientras los vehículos circulan por las carreteras.

Y primero en la lista de preocupaciones se encuentra un producto químico llamado 6PPD, que se agrega a los neumáticos para que duren más tiempo. Cuando los neumáticos se van desgastando por el roce con el pavimento, liberan 6PPD.

Al entrar en contacto con el ozono, esta sustancia reacciona y se convierte en un producto químico diferente, el 6PPD-q, que puede ser extremadamente tóxico, tanto que se ha relacionado con muertes de peces en el estado de Washington.

Pero los problemas no terminan ahí.

Los neumáticos están hechos principalmente de goma natural y goma sintética, pero contienen cientos de otros ingredientes, que a menudo incluyen acero y metales pesados como cobre, plomo, cadmio y zinc.

A medida que los neumáticos se desgastan, la goma desaparece en partículas, tanto trozos que se pueden ver a simple vista como micropartículas. Las pruebas realizadas por una empresa británica, Emissions Analytics, encontraron que los neumáticos de un automóvil emiten 1,000 millones de partículas ultrafinas por kilómetro conducido: entre 5 y 9 libras de goma por automóvil de combustión interna por año.

Y lo que hay en esas partículas es un misterio, porque los ingredientes de los neumáticos son de propiedad exclusiva.

“Tienes un cóctel químico en estos neumáticos que nadie realmente entiende y que los fabricantes de neumáticos mantienen en secreto”, dijo Nick Molden, CEO de Emissions Analytics. “Nos resulta difícil pensar en otro producto de consumo tan prevalente en el mundo y utilizado prácticamente por todos, donde se sepa tan poco sobre lo que contiene”.

Los reguladores apenas han comenzado a abordar el problema de la toxicidad en los neumáticos, aunque ha habido algunas acciones sobre el 6PPD.

El producto químico fue identificado por un equipo de investigadores, dirigido por científicos de la Universidad Estatal de Washington y de la Universidad de Washington, que estaban tratando de determinar por qué estaban muriendo masivamente los salmones coho que regresaban a arroyos del área de Seattle para desovar.

Trabajando para el Washington Stormwater Center, los científicos probaron alrededor de 2,000 sustancias para determinar cuál estaba causando las muertes, y en 2020 anunciaron que habían encontrado al culpable: 6PPD.

La Tribu Yurok en el norte de California, junto con otras dos tribus nativas de la costa oeste, han pedido a la Agencia de Protección Ambiental (EPA) que prohíba el producto químico. La EPA dijo que está considerando nuevas normas que lo regulen.

“No podríamos quedarnos de brazos cruzados mientras el 6PPD mata a los peces que nos sostienen”, dijo Joseph L. James, presidente de la Tribu Yurok, en un comunicado. “Esta toxina letal no tiene lugar en ninguna cuenca salmonera”.

California ha comenzado a tomar medidas para regular el producto químico. El año pasado comenzó a calificar a los neumáticos que lo contienen como un “producto prioritario”, lo que requiere que los fabricantes busquen y prueben sustitutos.

“El 6PPD juega un papel crucial en la seguridad de los neumáticos en las carreteras de California y, actualmente, no hay alternativas más seguras ampliamente disponibles”, dijo Karl Palmer, subdirector del Departamento de Control de Sustancias Tóxicas del estado. “Por esta razón, nuestro marco es ideal para identificar alternativas al 6PPD que sigan garantizado la seguridad de los neumáticos en las carreteras de California, protegiendo al mismo tiempo las poblaciones de peces y las comunidades que dependen de ellas”.

La Asociación de Fabricantes de Neumáticos de EE.UU. (USTMA) dice que ha movilizado un consorcio de 16 fabricantes para llevar a cabo un análisis de alternativas. Anne Forristall Luke, presidenta y CEO de la USTMA, dijo que “proporcionará la revisión más efectiva y exhaustiva posible de si existe una alternativa más segura al 6PPD en los neumáticos”.

Sin embargo, Molden dijo que hay un inconveniente. “Si no investigan, no se les permite vender en el estado de California”, dijo. “Si investigan y no encuentran una alternativa, pueden seguir vendiendo. No tienen que encontrar un sustituto. Y hoy no hay alternativa al 6PPD”.

California también está estudiando una solicitud de la California Stormwater Quality Association para clasificar los neumáticos que contienen zinc, un metal pesado, como un producto prioritario, lo que requeriría que los fabricantes busquen una alternativa. El zinc se utiliza en el proceso de vulcanización para aumentar la resistencia del caucho.

Sin embargo, cuando se trata de partículas de neumáticos, no ha habido ninguna acción, incluso cuando el problema empeora con la proliferación de automóviles eléctricos. Debido a su aceleración más rápida, los vehículos eléctricos desgastan los neumáticos más rápido y emiten aproximadamente un 20% más de partículas que los de un automóvil de gasolina promedio.

Un estudio reciente en el sur de California encontró que las emisiones de neumáticos y frenos en Anaheim representaban el 30% de PM2.5, un contaminante atmosférico de partículas pequeñas, mientras que las emisiones de escape representaban el 19%.

Las pruebas realizadas por Emissions Analytics han encontrado que los neumáticos producen hasta 2,000 veces más contaminación por partículas en masa que los tubos de escape. Estas partículas acaban en el agua y el aire y a menudo se ingieren. Los neumáticos también emiten partículas ultrafinas, incluso más pequeñas que PM2.5, que pueden ser inhaladas y viajar directamente al cerebro.

Nuevas investigaciones sugieren que las micropartículas de neumáticos deberían ser clasificadas como un contaminante de “alta preocupación”. En un informe el año pasado, investigadores del Imperial College de Londres dijeron que las partículas podrían afectar al corazón, los pulmones y los órganos reproductivos, y causar cáncer.

Las personas que viven o trabajan junto a carreteras, muchas veces de bajos ingresos, están expuestas a más de estas sustancias tóxicas.

Los neumáticos también son una fuente importante de microplásticos. Más de tres cuartas partes de los microplásticos que llegan al océano provienen de la goma sintética de los neumáticos, según un informe del Pew Charitable Trusts y la empresa británica Systemiq.

Y todavía hay muchas incógnitas sobre las emisiones de neumáticos, que pueden ser especialmente complejas de analizar porque el calor y la presión pueden transformar los ingredientes del neumático en otros compuestos.

Una pregunta pendiente de investigación es si el 6PPD-q afecta a las personas y qué problemas de salud, si los hay, podría causar. Un estudio reciente publicado en Environmental Science & Technology Letters encontró altos niveles del producto químico en muestras de orina de una región del sur de China, con niveles más altos en mujeres embarazadas.

Molden dijo que el descubrimiento del 6PPD-q ha generado un nuevo interés en el impacto sanitario y ambiental de los neumáticos, y espera una gran cantidad de nuevas investigaciones en los próximos años. “Las piezas del rompecabezas se están armando”, dijo. “Pero es un rompecabezas de mil piezas, no de doscientas”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

Un equipo de investigadores de Montana está jugando un papel clave en el desarrollo de una vacuna más efectiva contra la tuberculosis, una enfermedad infecciosa que ha matado a más personas que ninguna otra.

La BCG (Bacille Calmette-Guérin), desarrollada en 1921, sigue siendo la única vacuna contra la tuberculosis (TB). Si bien tiene una eficacia del 40% al 80% en niños pequeños, su efectividad es muy baja en adolescentes y adultos, lo que impulsó un esfuerzo mundial para encontrar una vacuna que sea más potente.

El Centro de Medicina Translacional de la Universidad de Montana está llevando a cabo una iniciativa en este sentido. El Centro se especializa en mejorar y crear vacunas, agregando los que se denominan “adyuvantes novedosos”.

Un adyuvante es una sustancia que se incluye en la vacuna, por ejemplo moléculas grasas o sales de aluminio, y que potencia la respuesta inmunitaria. Los adyuvantes novedosos son los que aún no se han utilizado en humanos. Los científicos están comprobando que estos adyuvantes generan una inmunidad más fuerte, precisa y duradera que los antígenos, que solo crean anticuerpos.

Provocar respuestas específicas del sistema inmunológico, y profundizar y ampliar su efectividad con adyuvantes, es algo que se conoce como “vacunación de precisión”.

“No es una solución única para todos, no se trata de una vacuna única”, explicó Ofer Levy, profesor de Pediatría de la Universidad de Harvard y director del Programa de Vacunas de Precisión del Hospital Infantil de Boston. “Una vacuna puede funcionar de forma diferente en un recién nacido, un adulto mayor o en una persona de mediana edad”, agregó.

Una vacuna de precisión definitiva, según Levy, brindaría protección de por vida contra una enfermedad con un solo pinchazo. “Una protección de una sola dosis que fuera efectiva contra la gripe o contra el covid sería el Santo Grial”, enfatizó Levy.

Jay Evans dirige el Centro de la Universidad de Montana y, a la vez, es cofundador y director científico y de estrategias, de Inimmune, una empresa privada de biotecnología de Missoula. Evans contó que su equipo lleva 15 años trabajando en una vacuna contra la tuberculosis y que aún faltan cinco años para que ésta pueda distribuirse ampliamente. La asociación público-privada está desarrollando vacunas e intentando mejorar las existentes, afirmó.

En el Centro no ha pasado inadvertido que este trabajo de investigación y producción de vacunas de vanguardia se realiza en Montana, el estado que aprobó una de las leyes antivacunas más extremas del país en 2021, durante la pandemia.

La ley prohíbe a empresas y gobiernos dar un trato diferente a las personas que no estén vacunadas contra covid u otras enfermedades. De hecho, prohíbe a los empleadores públicos y privados que les exijan a los trabajadores que se vacunen contra covid o cualquier otra enfermedad. Un juez federal dictaminó después que la ley no puede aplicarse en entornos sanitarios, como hospitales y consultas médicas.

A mediados de marzo, el Instituto de Investigación Médica Bill y Melinda Gates anunció que había iniciado en siete países la tercera y última fase de los ensayos clínicos de la nueva vacuna contra la tuberculosis. Los ensayos tardarán unos cinco años en completarse. La investigación y la producción se están llevando a cabo en varios lugares, incluida una planta de fabricación en Hamilton, propiedad de GSK, un gigante farmacéutico.

Conocida como “la pandemia olvidada”, la tuberculosis, a pesar de que se puede prevenir y tratar, mata hasta a 1,6 millones de personas al año, la mayoría en zonas empobrecidas de Asia y África.

En Estados Unidos se ha producido un aumento de esta enfermendad en la última década. Muchos inmigrantes tienen TB sin saberlo; en 2022 el número de casos aumentó un 16%. La tuberculosis es la principal causa de muerte entre las personas que viven con VIH, cuyo riesgo de contraer esta enfermedad es 20 veces mayor que el de las personas sin el virus.

“La tuberculosis es un patógeno complejo que ha acompañado a los seres humanos durante siglos”, dijo Alemnew Dagnew, que dirige el programa para la nueva vacuna en el Instituto de Investigación Médica Gates. “Debido a esta situación, ha evolucionado y ha podido desarrollar mecanismos para evadir al sistema inmunológico. Y la inmunología de la TB aún no se comprende completamente”.

En conjunto, el Centro de Medicina Translacional de la Universidad de Montana e Inimmune tienen 80 empleados especializados en la investigación de una variedad de adyuvantes con el propósito de comprender los detalles de las respuestas inmunitarias a diferentes sustancias. “Hay que adaptarlos al patógeno contra el que se vacuna, como si fueran un instrumento en una caja de herramientas”, dijo Evans. “Tenemos toda una biblioteca de moléculas y formulaciones de adyuvantes”.

Las vacunas se vuelven en gran medida más precisas mediante el uso de adyuvantes. Hay tres tipos básicos de adyuvantes naturales: sales de aluminio; escualeno, que se obtiene del hígado de tiburón; y algunos tipos de saponinas, que son moléculas grasas. No se sabe muy bien cómo estimulan el sistema inmunitario. El Centro de Missoula también ha creado y patentado un adyuvante sintético, el UM-1098, que induce un tipo específico de respuesta inmunitaria y que se añadirá a las nuevas vacunas.

Una de las moléculas más prometedoras que se están utilizando para potenciar la respuesta del sistema inmunológico a las vacunas es una molécula de saponina de la corteza del árbol de quillay, recolectada en Chile de árboles que tienen por lo menos una década.

Estas moléculas fueron utilizadas por Novavax en su vacuna contra covid y por GSK en Shingrix, su vacuna contra la culebrilla (shingles), de uso generalizado. Estas moléculas también son un componente clave en la nueva vacuna contra la tuberculosis, conocida como la vacuna M72.

Pero hay margen para mejorar.

“La vacuna muestra una eficacia del 50%, lo que no parece mucho, pero como actualmente se carece de otra vacuna más efectiva, el 50% es bastante mejor que lo que hay”, sostuvo Evans. “Buscamos aprovechar lo que aprendimos de ese desarrollo de la vacuna con adyuvantes adicionales para tratar de mejorarla y llevar ese índice desde el 50% hasta el 80% o más”.

Las vacunas contra el sarampión, en cambio, han alcanzado una efectividad del 95%.

Según el sitio web Medscape, en este momento se están desarrollando alrededor de 15 vacunas que son candidatas a reemplazar la BCG, y tres de ellas se encuentran en la fase 3 de ensayos clínicos.

Una alternativa que el Centro de Evans está investigando para mejorar la eficacia de la nueva vacuna es tomar una parte de la bacteria que causa la tuberculosis, sintetizarla y combinarla con el adyuvante QS-21, elaborado a partir del árbol de quillay. “Estimula el sistema inmunológico de una manera específica para la tuberculosis y genera una respuesta inmune que se acerca aún más a lo que obtenemos de las infecciones naturales”, dijo Evans.

Por su parte, el Centro de la Universidad de Montana está investigando el tratamiento de varias afecciones que generalmente no se consideran susceptibles de ser abordadas mediante vacunación. Por ejemplo, están ingresando en la primera fase de ensayos clínicos para una vacuna contra las alergias y para otra, contra el cáncer.

Avanzado este año, comenzarán los ensayos clínicos para obtener vacunas capaces de bloquear los efectos de opioides como la heroína y el fentanilo. La Universidad de Montana recibió la mayor subvención de su historia, $33 millones, para investigar una vacuna contra los opioides. Funciona creando un anticuerpo que se une a la droga en el torrente sanguíneo, evitando que entre al cerebro y produzca el efecto de euforia.

Por ahora, sin embargo, los expertos en salud de todo el mundo tienen sus ojos puestos en los ensayos de las nuevas vacunas contra la tuberculosis, que, si tienen éxito, podrían ayudar a salvar innumerables vidas en las regiones más pobres del mundo.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

Suicide prevention action plan

$700M IHS Infrastructure Investment

Services and Protections for Unaccompanied Children in Its Care

New technologies are making it easier for companies to fix prices and discriminate against individual consumers, the Biden administration’s top consumer watchdog said Tuesday.

Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF.

“I think we could be entering a somewhat novel era of pricing,” Khan told reporters.

Khan is regarded as one of the most aggressive antitrust regulators in recent U.S. history, and she has paid particular attention to the harm that technological advances can pose to consumers. Antitrust regulators at the FTC and the Justice Department set a record for merger challenges in the fiscal year that ended Sept. 30, 2022, according to Bloomberg News.

Last year, the FTC successfully blocked biotech company Illumina’s over $7 billion acquisition of cancer-screening company Grail. The FTC, Justice Department, and Health and Human Services Department launched a website on April 18, healthycompetition.gov, to make it easier for people to report suspected anticompetitive behavior in the health care industry.

The American Hospital Association, the industry’s largest trade group, has often criticized the Biden administration’s approach to antitrust enforcement. In comments in September on proposed guidance the FTC and Justice Department published for companies, the AHA said that “the guidelines reflect a fundamental hostility to mergers.”

Price fixing removes competition from the market and generally makes goods and services more expensive. The agency has argued in court filings that price fixing “is still illegal even if you are achieving it through an algorithm,” Khan said. “There’s no kind of algorithmic exemption to the antitrust laws.”

By simply using the same algorithms to set prices, companies can effectively charge the same “even if they’re not, you know, getting in a back room and kind of shaking hands and setting a price,” Khan said, using the example of residential property managers.

Khan said the commission is also scrutinizing the use of artificial intelligence and algorithms to set prices for individual consumers “based on all of this particular behavioral data about you: the websites you visited, you know, who you had lunch with, where you live.”

And as health care companies change the way they structure their businesses to maximize profits, the FTC is changing the way it analyzes behavior that could hurt consumers, Khan said.

Hiring people who can “help us look under the hood” of some inscrutable algorithms was a priority, Khan said. She said it’s already paid off in the form of legal actions “that are only possible because we had technologists on the team helping us figure out what are these algorithms doing.”

Traditionally, the FTC has policed health care by challenging local or regional hospital mergers that have the potential to reduce competition and raise prices. But consolidation in health care has evolved, Khan said.

Mergers of systems that don’t overlap geographically are increasing, she said. In addition, hospitals now often buy doctor practices, while pharmacy benefit managers start their own insurance companies or mail-order pharmacies — or vice versa — pursuing “vertical integration” that can hurt consumers, she said.

The FTC is hearing increasing complaints “about how these firms are using their monopoly power” and “exercising it in ways that’s resulting in higher prices for patients, less service, as well as worse conditions for health care workers,” Khan said.

Policing Noncompetes

Khan said she was surprised at how many health care workers responded to the commission’s recent proposal to ban “noncompete” clauses — agreements that can prevent employees from moving to new jobs. The FTC issued its final rule banning the practice on Tuesday. She said the ban was aimed at low-wage industries like fast food but that many of the comments in favor of the FTC’s plan came from health professions.

Health workers say noncompete agreements are “both personally devastating and also impeded patient care,” Khan said.

In some cases, doctors wrote that their patients “got really upset because they wanted to stick with me, but my hospital was saying I couldn’t,” Khan said. Some doctors ended up commuting long distances to prevent the rest of their families from having to move after they changed jobs, she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).