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Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent

Kaiser Health News - 10 hours 26 min ago

SACRAMENTO, Calif. — Gov. Gavin Newsom, whose administration is struggling to contain a worsening homelessness crisis despite record spending, is trying something bold: tapping federal health care funding to cover rent for homeless people and those at risk of losing their housing.

States are barred from using federal Medicaid dollars to pay directly for rent, but California’s governor is asking the administration of President Joe Biden, a fellow Democrat, to authorize a new program called “transitional rent,” which would provide up to six months of rent or temporary housing for low-income enrollees who rely on the state’s health care safety net — a new initiative in his arsenal of programs to fight and prevent homelessness.

“I’ve been talking to the president. We cannot do this alone,” Newsom told KHN.

The governor is pushing California’s version of Medicaid, called Medi-Cal, to fund experimental housing subsidies for homeless people, betting that it’s cheaper for taxpayers to cover rent than to allow people to fall into crisis or costly institutional care in hospitals, nursing homes, and jails. Early in his tenure, Newsom proclaimed that “doctors should be able to write prescriptions for housing the same way they do for insulin or antibiotics.”

But it’s a risky endeavor in a high-cost state where median rent is nearly $3,000 a month, and even higher in coastal regions, where most of California’s homeless people reside. Experts expect the Biden administration to scrutinize the plan to use health care money to pay rent; and also question its potential effectiveness in light of the state’s housing crisis.

“Part of the question is whether this is really Medicaid’s job,” said Vikki Wachino, who served as national Medicaid director in the Obama administration. “But there is a recognition that social factors like inadequate housing are driving health outcomes, and I think the federal government is open to developing approaches to try and address that.”

Bruce Alexander, a spokesperson for the Centers for Medicare & Medicaid Services, declined to say whether the federal government would approve California’s request. Yet, Biden’s Medicaid officials have approved similar experimental programs in Oregon and Arizona, and California is modeling its program after them.

California is home to an estimated 30% of the homeless people in the U.S., despite representing just 12% of the country’s overall population. And Newsom has acknowledged that the numbers are likely far greater than official homeless tallies show. Top health officials say that, to contain soaring safety-net spending and help homeless people get healthy, Medi-Cal has no choice but to combine social services with housing.

Statewide, 5% of Medi-Cal patients account for a staggering 44% of the program’s spending, according to state data. And many of the costliest patients lack stable housing: Nearly half of patients experiencing homelessness visited the emergency room four times or more in 2019 and were more likely than other low-income adults to be admitted to the hospital, and a large majority of visits were covered by Medi-Cal, according to the Public Policy Institute of California.

“What we have today doesn’t work,” said Dr. Mark Ghaly, secretary of the California Health and Human Services Agency, explaining his argument that housing is a critical component of health care. “Why do we have to wait so long for people to be so sick?”

The federal government has already approved a massive social experiment in California, known as CalAIM, which is transforming Medi-Cal. Over five years, the initiative is expected to pour $12 billion into new Medi-Cal services delivered outside of traditional health care. In communities across the state, it is already funding services for some low-income patients, including paying rental security deposits for homeless people and those facing eviction; delivering prepared healthy meals for people with diabetes; and helping formerly incarcerated people find jobs.

The transitional rent program would add another service to those already available, though only a sliver of the 15.4 million Medi-Cal enrollees actually receive those new and expensive social services.

Rent payments could begin as soon as 2025 and cost roughly $117 million per year once fully implemented. And while state officials say anyone who is homeless or at risk of becoming homeless would be eligible, not everyone who qualifies will receive new services due to capacity limits. Among those who stand to benefit are nearly 11,000 people already enrolled in Medi-Cal housing services.

“The ongoing conversation is how do we convince the federal government that housing is a health care issue,” said Mari Cantwell, who served as Medi-Cal director from 2015 to 2020. “You have to convince them that you’re going to save money because you’re not going to have as many people showing up at the emergency room and in long-term hospitalizations.”

Health care experiments in California and around the country that funded housing supports have demonstrated early success in reducing costs and making people healthier. But while some programs paid for housing security deposits or participants’ first month of rent, none directly covered rent for an extended period.

“Without that foundational support, we are playing in the margins,” Newsom said.

State health officials argue that paying for six months of rent will be even more successful at reducing health care costs and improving enrollees’ health, but experts say that, to work, the initiative must have strict accountability and be bundled with an array of social services.

In a precursor to the state’s current initiative, California experimented with a mix of housing assistance programs and social services through its “Whole Person Care” pilot program. Nadereh Pourat, of the UCLA Center for Health Policy Research, evaluated the program for the state concluding that local trials reduced emergency visits and hospitalizations, saving an average of $383 per Medi-Cal beneficiary per year — a meager amount compared with the program’s cost.

Over five years, the state spent $3.6 billion serving about 250,000 patients enrolled in local experiments, Pourat said.

And a randomized control trial in Santa Clara County that provided supportive housing for homeless people showed reductions in psychiatric emergency room visits and improvements in care. “Lives stabilized and we saw a huge uptick in substance use care and mental health care, the things that everybody wants people to use to get healthier,” said Dr. Margot Kushel, director of the University of California-San Francisco’s Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, who worked on the study.

But insurers implementing the broader Medi-Cal initiative say they are skeptical that spending health care money on housing will save the system money. And health care experts say that, while six months of rent can be a bridge while people wait for permanent housing, there’s a bigger obstacle: California’s affordable housing shortage.

“We can design incredible Medicaid policies to alleviate homelessness and pay for all the necessary supportive services, but without the adequate housing, frankly, it’s not going to work,” Kushel said.

Newsom acknowledges that criticism. “The crisis of homelessness will never be solved without first solving the crisis of housing,” he said last week, arguing California should plow more money into housing for homeless people with severe mental health conditions or addiction disorders.

He will ask the legislature to put before voters a 2024 ballot initiative that would infuse California’s mental health system with at least 6,000 new treatment beds and supportive housing units for people struggling with mental health and addiction disorders, many of whom are homeless. The proposed bond measure would generate from $3 billion to $5 billion for psychiatric housing and treatment villages aimed at serving more than 10,000 additional people a year. The initiative also would ask voters to set aside at least $1 billion a year for supportive housing from an existing tax on California millionaires that funds local mental health programs. 

“People who are struggling with these issues, especially those who are on the streets or in other vulnerable conditions, will have more resources to get the help they need,” Newsom said.

For transitional rent, six months of payments would be available for select high-need residents enrolled in Medi-Cal, particularly those who are homeless or at risk of becoming homeless — and those transitioning from more costly institutions such as mental health crisis centers, jails and prisons, and foster care. Medi-Cal patients at risk of inpatient hospitalization or who frequent the emergency room would also be eligible.

“It’s a pretty big challenge; I’m not going to lie,” said Jacey Cooper, the Medi-Cal director. “But we know that people experiencing homelessness cycle in and out of emergency rooms, so we have a real role to play in both preventing and ending homelessness.”

Public health experts say the problem will continue to explode without creative thinking about how to fund housing in health care, but they warn the state must be wary of potential abuses of the program.

“It has to be designed carefully because, unfortunately, there are always people looking to game the system,” said Dr. Tony Iton, a public health expert who is now a senior vice president at the California Endowment. “Decisions must be made by clinicians — not housing organizations just looking for another source of revenue.”

For Stephen Morton, who lives in the Orange County community of Laguna Woods, the journey from homelessness into permanent housing illustrates the amount of public spending it can take for the effort to pay off.

Morton, 60, bounced between shelters and his car for nearly two years and racked up extraordinary Medi-Cal costs due to prolonged hospitalizations and repeated emergency room trips to treat chronic heart disease, asthma, and diabetes.

Medi-Cal covered Morton’s open-heart surgery and hospital stays, which lasted weeks. He landed temporary housing through a state-sponsored program called Project Roomkey before getting permanent housing through a federal low-income housing voucher — an ongoing benefit that covers all but $50 of his rent.

Since getting his apartment, Morton said, he’s been able to stop taking one diabetes medication and lose weight. He attributes improvements in his blood sugar levels to his housing and the healthy, home-delivered meals he receives via Medi-Cal.

“It’s usually scrambled eggs for breakfast and the fish menu for dinner. I’m shocked it’s so good,” Morton said. “Now I have a microwave and I’m indoors. I’m so grateful and so much healthier.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is 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.

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Categories: Health Care

End of Covid Emergency Will Usher in Changes Across the US Health System

Kaiser Health News - 10 hours 26 min ago

The Biden administration’s decision to end the covid-19 public health emergency in May will institute sweeping changes across the health care system that go far beyond many people having to pay more for covid tests.

In response to the pandemic, the federal government in 2020 suspended many of its rules on how care is delivered. That transformed essentially every corner of American health care — from hospitals and nursing homes to public health and treatment for people recovering from addiction.

Now, as the government prepares to reverse some of those steps, here’s a glimpse at ways patients will be affected:

Training Rules for Nursing Home Staff Get Stricter

The end of the emergency means nursing homes will have to meet higher standards for training workers.

Advocates for nursing home residents are eager to see the old, tougher training requirements reinstated, but the industry says that move could worsen staffing shortages plaguing facilities nationwide.

In the early days of the pandemic, to help nursing homes function under the virus’s onslaught, the federal government relaxed training requirements. The Centers for Medicare & Medicaid Services instituted a national policy saying nursing homes needn’t follow regulations requiring nurse aides to undergo at least 75 hours of state-approved training. Normally, a nursing home couldn’t employ aides for more than four months unless they met those requirements.

Last year, CMS decided the relaxed training rules would no longer apply nationwide, but states and facilities could ask for permission to be held to the lower standards. As of March, 17 states had such exemptions, according to CMS — Georgia, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, and Washington — as did 356 individual nursing homes in Arizona, California, Delaware, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New Hampshire, North Carolina, Ohio, Oregon, Virginia, Wisconsin, and Washington, D.C.

Nurse aides often provide the most direct and labor-intensive care for residents, including bathing and other hygiene-related tasks, feeding, monitoring vital signs, and keeping rooms clean. Research has shown that nursing homes with staffing instability maintain a lower quality of care.

Advocates for nursing home residents are pleased the training exceptions will end but fear that the quality of care could nevertheless deteriorate. That’s because CMS has signaled that, after the looser standards expire, some of the hours that nurse aides logged during the pandemic could count toward their 75 hours of required training. On-the-job experience, however, is not necessarily a sound substitute for the training workers missed, advocates argue.

Adequate training of aides is crucial so “they know what they’re doing before they provide care, for their own good as well as for the residents,” said Toby Edelman, a senior policy attorney for the Center for Medicare Advocacy.

The American Health Care Association, the largest nursing home lobbying group, released a December survey finding that roughly 4 in 5 facilities were dealing with moderate to high levels of staff shortages.

Treatment Threatened for People Recovering From Addiction

A looming rollback of broader access to buprenorphine, an important medication for people in recovery from opioid addiction, is alarming patients and doctors.

During the public health emergency, the Drug Enforcement Administration said providers could prescribe certain controlled substances virtually or over the phone without first conducting an in-person medical evaluation. One of those drugs, buprenorphine, is an opioid that can prevent debilitating withdrawal symptoms for people trying to recover from addiction to other opioids. Research has shown using it more than halves the risk of overdose.

Amid a national epidemic of opioid addiction, if the expanded policy for buprenorphine ends, “thousands of people are going to die,” said Ryan Hampton, an activist who is in recovery.

The DEA in late February proposed regulations that would partly roll back the prescribing of controlled substances through telemedicine. A clinician could use telemedicine to order an initial 30-day supply of medications such as buprenorphine, Ambien, Valium, and Xanax, but patients would need an in-person evaluation to get a refill.

For another group of drugs, including Adderall, Ritalin, and oxycodone, the DEA proposal would institute tighter controls. Patients seeking those medications would need to see a doctor in person for an initial prescription.

David Herzberg, a historian of drugs at the University at Buffalo, said the DEA’s approach reflects a fundamental challenge in developing drug policy: meeting the needs of people who rely on a drug that can be abused without making that drug too readily available to others.

The DEA, he added, is “clearly seriously wrestling with this problem.”

Hospitals Return to Normal, Somewhat

During the pandemic, CMS has tried to limit problems that could arise if there weren’t enough health care workers to treat patients — especially before there were covid vaccines when workers were at greater risk of getting sick.

For example, CMS allowed hospitals to make broader use of nurse practitioners and physician assistants when caring for Medicare patients. And new physicians not yet credentialed to work at a particular hospital — for example, because governing bodies lacked time to conduct their reviews — could nonetheless practice there.

Other changes during the public health emergency were meant to shore up hospital capacity. Critical access hospitals, small hospitals located in rural areas, didn’t have to comply with federal rules for Medicare stating they were limited to 25 inpatient beds and patients’ stays could not exceed 96 hours, on average.

Once the emergency ends, those exceptions will disappear.

Hospitals are trying to persuade federal officials to maintain multiple covid-era policies beyond the emergency or work with Congress to change the law.

Surveillance of Infectious Diseases Splinters

The way state and local public health departments monitor the spread of disease will change after the emergency ends, because the Department of Health and Human Services won’t be able to require labs to report covid testing data.

Without a uniform, federal requirement, how states and counties track the spread of the coronavirus will vary. In addition, though hospitals will still provide covid data to the federal government, they may do so less frequently.

Public health departments are still getting their arms around the scope of the changes, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

In some ways, the end of the emergency provides public health officials an opportunity to rethink covid surveillance. Compared with the pandemic’s early days, when at-home tests were unavailable and people relied heavily on labs to determine whether they were infected, testing data from labs now reveals less about how the virus is spreading.

Public health officials don’t think “getting all test results from all lab tests is potentially the right strategy anymore,” Hamilton said. Flu surveillance provides a potential alternative model: For influenza, public health departments seek test results from a sampling of labs.

“We’re still trying to work out what’s the best, consistent strategy. And I don’t think we have that yet,” Hamilton said.

KHN (Kaiser Health News) is 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.

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A Lot of Thought, Little Action: Proposals About Mental Health Go Unheeded

Kaiser Health News - 10 hours 26 min ago

Thousands of people struggle to access mental health services in Florida. The treatment system is disjointed and complex. Some residents bounce between providers and are prescribed different medications with clinicians unaware of what happened. Jails and prisons have become de facto homes for many who need care.

These problems and more were identified in a scathing report released earlier this year by the Commission on Mental Health and Substance Abuse, a 19-person panel that Florida lawmakers created in 2021 to push for reforms of the state’s patchwork of behavioral health services for uninsured people and low-income families.

What’s most troubling about the group’s findings? They aren’t new.

More than 20 years ago, the Florida Legislature set up a commission with the same name to examine the same issues and publish recommendations on how to improve mental health care in the publicly funded system.

The echoes between the two groups — over two decades apart — are unmistakable. And Florida isn’t the only state struggling with the criminalization of mental illness, a lack of coordination between providers, and insufficient access to treatment.

Last year, the national advocacy group Mental Health America said Florida ranked 46th among the 50 states and the District of Columbia for access to such care. Arizona, Kansas, Georgia, Alabama, and Texas were worse off, according to the nonprofit, which based its rankings on access to insurance, treatment, and special education, along with the cost and quality of insurance and the number of mental health providers.

Conversations about mental health are at the forefront nationwide amid the proliferation of mass shootings, pandemic-related stress, rising suicide rates, and shifting viewpoints on the role of police in handling 911 calls.

“It comes down to how much investment, financially, legislators are willing to put into building a system that works,” said Caren Howard, director of policy and advocacy at Mental Health America, a nonprofit just outside Washington, D.C.

In Florida, the 1999 Commission on Mental Health and Substance Abuse was launched when Jeb Bush was governor. In a 74-page report released in 2001, the group called the state’s treatment system “complex, fragmented, uncoordinated and often ineffective.”

The commission found that jails and prisons were Florida’s “largest mental hospitals” after “deinstitutionalization” began — the 20th-century movement to shutter state psychiatric facilities and treat people instead through community services.

The report also blasted Florida agencies for not sharing patient data with one another and being unable to track whether those with severe mental illnesses like schizophrenia were truly getting needed help.

“A lot of the things that we’re finding now, they found back then,” said Charlotte County Sheriff Bill Prummell, a member of the latest commission who served as the chairperson for about 18 months.

The similarities raise questions for the group about whether its work will also end up on a shelf, collecting dust, as Florida lawmakers continue to wrestle with the same challenges again and again.

“Are they really going to take us seriously?” Prummell asked.

Dropping the Ball

After hosting public meetings across Florida, the 1999 commission urged a slate of reforms, including expanding jail diversion programs like mental health courts.

But the group’s key recommendation was to set up a “coordinating council” in the governor’s office to lead the system and develop a strategy for care.

That never happened.

David Shern, chairperson of the 1999 group and former dean of the University of South Florida’s Louis de la Parte Florida Mental Health Institute, said he thinks Bush’s office dropped the ball.

The Republican governor, known for his spending cuts, didn’t want to add staff to his office, so the coordinating council was never created, said Shern.

That’s “where the plan really fell apart,” he said.

Instead, lawmakers established a work group in the Department of Children and Families to review how Florida could improve its behavioral health system and submit a report to Bush, among other leaders.

The work group disbanded in 2003. That same year, the legislature created a not-for-profit corporation to oversee the system, but it was dissolved in 2011, according to state business records. When the Tampa Bay Times recently asked for the work group’s report, Laura Walthall, a spokesperson for the Department of Children and Families, said it couldn’t be found. Bush didn’t respond to emailed questions.

Former state Rep. Sandra Murman, however, said that what happened is just a reality of bureaucracy.

“It’s the same with all commissions,” said Murman, a Tampa Republican who was part of the 1999 group. “The life cycle of any big report that comes out is probably about five years.”

Lawmakers leave Tallahassee because of term limits. Agency heads step down. New officials get elected. Priorities shift.

“They come in with their agenda, and you won’t see social services ever at the top,” she said of Florida legislative leaders.

But some state lawmakers focused on mental illness in the wake of the 2018 shooting that left 17 students and staff members dead at Marjory Stoneman Douglas High School in Parkland. Amid mounting public demand for more drastic gun control measures, such as an assault weapons ban, the Republican-controlled legislature instead approved more limited restrictions, like Florida’s “red flag” law, along with steps unrelated to gun control, allocating about $400 million for mental health and school safety initiatives.

Before the massacre, Parkland shooter Nikolas Cruz received mental health services through several public and private providers, splitting the future gunman’s medical history, according to a 2019 report from the Marjory Stoneman Douglas High School Public Safety Commission.

“No single health professional or entity had the entire ‘story’ regarding Cruz’s mental health and family issues, due, in part, to an absence of communication between providers and a lack of disclosure by the Cruz family,” the report said.

The vast majority of people with a mental illness are not violent, according to the nonprofit National Council for Mental Wellbeing in Washington, D.C. And they are more likely to be victims of violent crime than perpetrators.

In 2020, a grand jury investigating school safety issues related to the shooting called Florida’s mental health care system “a mess.”

“Deficiencies in funding, leadership and services,” the grand jury said, “tend to turn up everywhere like bad pennies.”

The panel said it didn’t have enough time to conduct a full review of the system and urged state lawmakers to set up a commission to do so.

The latest commission reported that the system remains splintered and suffers from “enormous gaps in treatment.” And there’s still no centralized database on patients.

The group, just like its predecessor over two decades ago, has suggested that Florida create more jail diversion programs and that state agencies share patient data. The commission has pitched new ideas, too, like a pilot program in which one agency manages all public behavioral health funding in a geographic area, including state money and local dollars, so providers can focus more on care and less on complicated billing processes.

“This isn’t going away, and if we don’t address it, it’s going to get worse,” Prummell told a House subcommittee last month.

Solutions to Florida’s problems are not headline grabbers, which makes it tough to generate political support, said Holly Bullard, chief strategy and development officer at the Florida Policy Institute, an Orlando nonprofit.

“Building good government, it can get technical,” she said, “and sometimes it’s hard to communicate the importance of it.”

Will Anything Change?

There’s been some progress in Florida’s mental health care system since 2001, said Jay Reeve, the new chairperson of the latest commission and CEO of Apalachee Center, a behavioral health provider in Tallahassee.

The system is more responsive to regional issues, partly because of state contracts with seven “managing entities” — nonprofits that oversee safety-net services for the uninsured, he said.

There’s also been an increase in initiatives like mobile response teams, which help people in mental health emergencies, and crisis intervention training for police officers, in which they get trained on de-escalation techniques and psychiatric diagnoses so they know when to get residents into treatment instead of arresting them, Reeve said.

The Department of Children and Families used to spend about $500 million a year on community-based behavioral health services such as outpatient treatment, case management, and crisis stabilization units, the 1999 commission reported. Now, its budget for such care is $1.1 billion.

Pockets of innovation exist at the local level, too, as in Palm Beach County, where an initiative called BeWellPBC aims to boost the area’s mental health care workforce, among other things, said Shern, senior associate in the department of mental health at the Johns Hopkins Bloomberg School of Public Health.

But challenges remain.

Nearly 3 million Florida adults have a mental illness, according to Mental Health America. That’s about 17% of the state’s population of those 18 and up. An estimated 225,000 youths experienced at least one major depressive episode in the past year, the nonprofit reported in October.

In 2020, Florida ranked last among states for per capita mental health care funding, the Parkland grand jury said. In 2021, the Miami-Dade County jail system was the largest psychiatric institution in the state, according to the 11th Judicial Circuit.

“As long as you keep things siloed, accountability is easier to dodge,” said Ann Berner, a member of the 2021 commission and CEO of Southeast Florida Behavioral Health Network, a managing entity.

Political will is needed to enact major reforms, Shern said. So is follow-up on the commission’s work, said Murman, who works at Shumaker Advisors Florida, a lobbying firm.

“In this case, it probably is something that has to be revived every five years to really make an impact,” she said.

Rep. Christine Hunschofsky, a Parkland Democrat on the 2021 commission, said there’s bipartisan support to improve the system.

But during the current legislative session, the Tampa Bay Times on March 13 could find only one House bill and a matching Senate bill based on the commission’s 35-page interim report: a proposal to study Medicaid expansion for some young adults age 26 and under. (Republican leaders in Florida have refused to expand the federal-state health care program under the Affordable Care Act, which became law in 2010.)

Hunschofsky said she thinks the legislature will take more action once the commission releases its final report, which is due by Sept. 1.

Republican Gov. Ron DeSantis’ office referred questions to the Department of Children and Families, where officials didn’t answer them.

Senate President Kathleen Passidomo didn’t respond to a voicemail and interview requests made through a spokesperson. Nor could House Speaker Paul Renner be reached for comment.

After more than 20 years, Shern is frustrated.

“It’s time to move on these issues,” he said. “We’ve spent literally decades thinking about them, talking about them.”

This article was produced in partnership with the Tampa Bay Times.

KHN (Kaiser Health News) is 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.

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Categories: Health Care

Some Roadblocks to Lifesaving Addiction Treatment Are Gone. Now What?

Kaiser Health News - Tue, 03/21/2023 - 5:00am

For two decades — as opioid overdose deaths rose steadily — the federal government limited access to buprenorphine, a medication that addiction experts consider the gold standard for treating patients with opioid use disorder. Study after study shows it helps people continue addiction treatment while reducing the risk of overdose and death.

Clinicians who wanted to prescribe the medicine had to complete an eight-hour training. They could treat only a limited number of patients and had to keep special records. They were given a Drug Enforcement Administration registration number starting with X, a designation many doctors say made them a target for drug-enforcement audits.

“Just the process associated with taking care of our patients with a substance use disorder made us feel like, ‘Boy, this is dangerous stuff,'” said Dr. Bobby Mukkamala, who chairs an American Medical Association task force addressing substance use disorder.

“The science doesn’t support that but the rigamarole suggested that.”

That rigamarole is mostly gone. Congress eliminated what became known as the “X-waiver” in legislation President Joe Biden signed late last year. Now begins what some addiction experts are calling a “truth serum moment.”

Were the X-waiver and the burdens that came with it the real reason only about 7% of clinicians in the U.S. were cleared to prescribe buprenorphine? Or were they an excuse that masked hesitation about treating addiction, if not outright disdain for these patients?

There’s great optimism among some leaders in the field that getting rid of the X-waiver will expand access to buprenorphine and reduce overdoses. One study from 2021 shows taking buprenorphine or methadone, another opioid agonist treatment, reduces the mortality risk for people with opioid dependence by 50%. The medication is an opioid that produces much weaker effects than heroin or fentanyl and reduces cravings for those deadlier drugs.

The nation’s drug czar, Dr. Rahul Gupta, said getting rid of the X-waiver would ultimately prevent millions of deaths.

“The impact of this will be felt for years to come,” Gupta said. “It is a true historic change that, frankly, I could only dream of being possible.”

Gupta and others envision obstetricians prescribing buprenorphine to their pregnant patients, infectious disease doctors adding it to their medical toolbox, and lots more patients starting buprenorphine when they come to emergency rooms, primary care clinics, and rehabilitation facilities.

We are “transforming the way we think to make every moment an opportunity to start this treatment and save someone’s life,” said Dr. Sarah Wakeman, the medical director for substance use disorder at Mass General Brigham in Boston.

Wakeman said clinicians she has been contacting for the past decade are finally willing to consider treating patients with buprenorphine. Still, she knows stigma and discrimination could undermine efforts to help those who aren’t being served. In 2021, a national survey showed just 22% of people with opioid use disorder received medications such as buprenorphine and methadone.

The test of whether clinicians will step up and if prescribing will become more widespread is underway in hospitals and clinics across the country as patients struggling with addiction queue up for treatment. A woman named Kim, 65, is among them.

Kim’s recent visit to the Greater New Bedford Community Health Center in southern Massachusetts began in an exam room with Jamie Simmons, a registered nurse who runs the center’s addiction treatment program but doesn’t have prescribing powers. KHN agreed to use only Kim’s first name to limit potential discrimination linked to her drug use.

Kim told Simmons that buprenorphine had helped her stay off heroin and avoid an overdose for nearly 20 years. Kim takes a medication called Suboxone, a combination of buprenorphine and naloxone, which comes in the form of thin, filmlike strips she dissolves under her tongue.

“It’s the best thing they could have ever come out with,” Kim said. “I don’t think I ever even had a desire to use heroin since I’ve been taking them.”

Buprenorphine can produce mild euphoria and slow breathing but there’s a ceiling on the effects. Patients like Kim may develop a tolerance and not experience any effects.

“I don’t get high on Suboxones,” Kim said. “They just keep me normal.”

Still, many clinicians have been hesitant to use buprenorphine — known as a partial opioid agonist — to treat an addiction to more deadly forms of the drug.

Kim’s primary care doctor at the health center never applied for an X-waiver. So for years Kim bounced from one treatment program to another, seeking a prescription. During lapses in her access to buprenorphine, the cravings returned — an especially scary prospect after the powerful opioid fentanyl largely replaced heroin on the streets of Massachusetts, where Kim lives.

“I’ve seen so many people fall out in the last month,” Kim said, using a slang term for overdosing. “That stuff is so strong that within a couple minutes, boom.”

Because fentanyl can kill so quickly, the benefits of taking buprenorphine and other medications to treat opioid use disorder have increased as deaths linked to even stronger types of fentanyl rise.

Buprenorphine is present in a small percentage of overdose deaths nationwide, 2.6%. Of those, 93% involved a mix of one or more other drugs, often benzodiazepines. Fentanyl is in 94% of overdose deaths in Massachusetts.

“Bottom line is, fentanyl kills people, buprenorphine doesn’t,” Simmons said.

That reality added urgency to Kim’s health center visit because Kim took her last Suboxone before arriving; her latest prescription had run out.

Cravings for heroin could have returned in about a day if she didn’t get more Suboxone. Simmons confirmed the dose and told Kim that her primary care doctor might be willing to renew the prescription now that the X-waiver is not required. But Dr. Than Win had some concerns after reviewing Kim’s most recent urine test. It showed traces of cocaine, fentanyl, marijuana, and Xanax, and Win said she was worried about how the street drugs might interact with buprenorphine.

“I don’t want my patients to die from an overdose,” Win said. “But I’m not comfortable with the fentanyl and a lot of narcotics in the system.”

Kim was adamant that she did not intentionally ingest fentanyl, saying it might have been in the cocaine she said her roommate shares occasionally. Kim said she takes the Xanax to sleep. Her drug use presents complications that many primary care doctors don’t have experience managing. Some clinicians are apprehensive about using an opioid to treat an addiction to opioids, despite compelling evidence that doing so can save patients’ lives.

Win was worried about writing her first prescription for Suboxone. But she agreed to help Kim stay on the medication.

“I wanted to start with someone a little bit easier,” Win said. “It’s hard for me; that’s the reality and truth.”

About half of the providers at the Greater New Bedford health center had an X-waiver when it was still required. Attributing some of the resistance to having the waiver to stigma or misunderstanding about addiction, Simmons urged doctors to treat addiction as they would any other disease.

“You wouldn’t not treat a diabetic; you wouldn’t not treat a patient who is hypertensive,” Simmons said. “People can’t control that they formed an addiction to an opiate, alcohol, or a benzo.”

Searching for Solutions to Soften Stigma

Although the restrictions on buprenorphine prescribing are no longer in place, Mukkamala said the perception created by the X-waiver lingers.

“That legacy of elevating this to a level of scrutiny and caution —that needs to be sort of walked back,” Mukkamala said. “That’s going to come from education.”

Mukkamala sees promise in the next generation of doctors, nurse practitioners, and physician assistants coming out of schools that have added addiction training. The AMA and the American Society of Addiction Medicine have online resources for clinicians who want to learn on their own.

Some of these resources may help fulfill a new training requirement for clinicians who prescribe buprenorphine and other controlled narcotics. It will take effect in June. The DEA has not issued details about the training.

But training alone may not shift behavior, as Rhode Island’s experience shows.

The number of Rhode Island practitioners approved to prescribe buprenorphine increased roughly threefold from 2016 to 2022 after the state said physicians in training should obtain an X-waiver. Still, having the option to prescribe buprenorphine “didn’t open the floodgates” for patients in need of treatment, said Dr. Jody Rich, an addiction specialist who teaches at Brown University. From 2016 to 2022, when the number of qualified prescribers increased, the number of patients taking buprenorphine also increased, but by a much smaller percentage.

“It all comes back to stigma,” Rich said.

He said long-standing resistance among some providers to treating addiction is shifting as younger people enter medicine. But tackling the opioid crisis can’t wait for a generational change, he said. To expand buprenorphine access now, states could use pharmacists, partnered with doctors, to help manage the care of more patients with opioid use disorder, Rich’s research shows.

Wakeman, at Mass General Brigham, said it might be time to hold clinicians who don’t provide addiction care accountable through quality measures tied to payments.

“We’re expected to care for patients with diabetes or to care for patients with heart attack in a certain way and the same should be true for patients with an opioid use disorder,” Wakeman said.

One quality measure to track could be how often prescribers start and continue buprenorphine treatment. Wakeman said it would help also if insurers reimbursed clinics for the cost of staff who aren’t traditional clinicians but are critical in addiction care, like recovery coaches and case managers.

Will Ending the X-Waiver Close Racial Gaps?

Wakeman and others are paying especially close attention to whether eliminating the X-waiver helps narrow racial gaps in buprenorphine treatment. The medication is much more commonly prescribed to white patients with private insurance or who can pay cash. But there are also stark differences by race at some health centers where most patients are on Medicaid and would seem to have equal access to the addiction treatment.

At the New Bedford health center, Black patients represent 15% of all patients but only 6% of those taking buprenorphine. For Hispanics, it is 30% to 23%. Most of the health center patients prescribed buprenorphine, 61%, are white, though white patients make up just 36% of patients overall.

Dr. Helena Hansen, who co-authored a book on race in the opioid epidemic, said access to buprenorphine doesn’t guarantee that patients will benefit from it.

“People are not able to stay on a lifesaving medication unless the immense instability in housing, employment, social supports — the very fabric of their communities — is addressed,” Hansen said. “That’s where we fall incredibly short in the United States.”

Hansen said expanding access to buprenorphine has helped reduce overdose deaths dramatically among all drug users in France, including those with low incomes and immigrants. There, patients with opioid use disorder are seen in their communities and offered a wide range of social services.

“Removing the X-waiver,” Hansen said, “is not in itself going to revolutionize the opioid overdose crisis in our country. We would need to do much more.”

This article is part of a partnership that includes WBURNPR, and KHN.

KHN (Kaiser Health News) is 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.

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Mental Health Care by Video Fills Gaps in Rural Nursing Homes

Kaiser Health News - Tue, 03/21/2023 - 5:00am

KNOXVILLE, Iowa ― Bette Helm was glad to have someone to talk with about her insomnia.

Helm lives in a nursing home in this central Iowa town of about 7,500 people, where mental health services are sparse. On a recent morning, she had an appointment with a psychiatric nurse practitioner about 800 miles away in Austin, Texas. They spoke via video, with Helm using an iPad she held on her lap while sitting in her bed.

Video visits are an increasingly common way for residents of small-town nursing homes to receive mental health care. Patients don’t have to travel to a clinic. They don’t even have to get cleaned up and leave their bedrooms, which can be daunting for people with depression or anxiety. Online care providers face fewer appointment cancellations, and they often can work from home. While use of some other telehealth services may dwindle as the covid-19 pandemic winds down, providers predict demand for remote mental health services will continue to increase in rural nursing homes.

“Are you anxious when you try to fall asleep? Is your mind racing?” asked the nurse practitioner, Ayesha Macon.

“Yeah, that’s sort of my time to think,” Helm said. Her thoughts can keep her up past 3 a.m., she said.

They discussed the anxiety Helm sometimes feels during the day and her routine of watching the TV news at 10 p.m. Macon suggested the news might wind Helm up, and she wondered if the 71-year-old patient could ease stress by skipping the news before going to bed.

“No,” Helm said. “I find it interesting. I want to know what’s going on in the world. I’ve always been a bit of a newshound.”

Macon smiled and said she understood. So they talked about other approaches, including using online meditation programs and spending quiet time reading the dozens of novels Helm keeps stacked in her room. “If I couldn’t read, I think I would go absolutely bananas,” she told Macon, who agreed it was a good habit.

Telemedicine visits became much more common throughout the American health care system during the pandemic, as guidelines on “social distancing” curtailed in-person appointments and insurers eased restrictions on what they would cover. The number of telehealth visits paid for by Medicare jumped tenfold in the last nine months of 2020 compared with the same period a year before.

Supporters of online treatment say it’s a good match for mental health care, especially in settings where in-person services have been hard to arrange. They cite small-town nursing homes as prime examples. The company that arranged Helm’s recent appointment, Encounter Telehealth, serves more than 200 nursing homes and assisted living centers, mostly in the Midwest. About 95% of those facilities are in rural areas, said Jen Amis, president of the company, which is based in Omaha, Nebraska.

Encounter Telehealth uses about 20 mental health professionals, many of whom are psychiatric nurse practitioners living in cities. The practitioners read the patients’ electronic medical records through a secure computer system, and they review symptoms and medications with nursing home staff members before each appointment. They complete up to 2,000 visits a month.

It’s important for seniors to have expert support as they face stress and uncertainty in aging, Amis said. “We’re all going to be there at some point,” she said. “Don’t you want that last chapter to be peaceful?”

The company saw demand for its services surge in care facilities when the pandemic hit. Nursing homes were closed to visitors for months at a time while the coronavirus caused thousands of illnesses and deaths among residents and employees. The stress could be overwhelming for everyone involved. “Oh, my gosh, the isolation and fear,” Amis said.

Amis said several developments have made her company’s services possible. Electronic medical records and video systems are crucial. Also, she said, many states have given more independent authority to nurse practitioners and other nonphysicians, and it has become easier to bill public and private insurance plans for mental health treatment.

The federal government could tighten rules for some kinds of telehealth care as the pandemic wanes. But Medicare paid for many remote mental health visits to rural areas before covid, and Amis expects the support to continue.

Jonathan Neufeld, program director of the Great Plains Telehealth Resource and Assistance Center at the University of Minnesota, said in-person mental health care can be hard to arrange in rural care facilities.

“You’ve got a double or even triple whammy going right now,” said Neufeld, a psychologist whose center is supported by federal grants.

He noted the number of mental health professionals nationally has been insufficient for many years, even before the pandemic. And all kinds of rural employers, including nursing homes, face critical staffing shortages.

Neufeld said telehealth visits can be a challenge for some care-facility residents, including those with dementia, who might not understand how a video feed works. But he said it also can be difficult to treat people with dementia in person. Either way, a staff member or relative needs to accompany them during appointments and the mental health professional generally consults with facility staff about a patient’s treatment.

Before telemedicine was available, more residents of rural nursing homes needed to be driven to a clinic in another town to see a mental health professional. That could eat up hours of staff time and add stress to the patients’ lives.

Seleta Stewart, a certified nursing assistant at the Accura HealthCare nursing home where Helm lives, said the facility’s need for the telehealth service is increasing, partly because the facility is home to several younger residents with mental illnesses. In the past, she said, many such Iowans would have been served by specialized facilities, such as two state mental hospitals that closed in 2015. But more now live in nursing homes.

“Iowa is just not a great state for mental health,” Stewart said.

Neufeld said that, even with telemedicine’s efficiencies, staffing can be a challenge for companies providing the service in nursing homes. Many mental health professionals already have more patients than they can handle, and they might not have time to pitch in online. He added that Medicare, which insures most seniors, pays lower rates than private insurers or patients paying on their own.

Amis, Encounter Telehealth’s president, said Medicare pays about $172 for an initial appointment and about $107 for a follow-up appointment; care providers collect roughly 30% to 75% more from patients who use private insurance or pay their own bills, she said. She added that nursing homes pay a fee to Encounter for the convenience of having mental health professionals visit by video.

Several patients and care providers said the shift to video appointments is usually smooth, despite seniors’ reputation for being uncomfortable with new technology.

Dr. Terry Rabinowitz, a psychiatrist and professor at the University of Vermont, has been providing telemedicine services to a rural nursing home in upstate New York since 2002. He said many patients quickly adjust to video visits, even if it’s not their initial preference.

“I think most people, if they had their druthers, would rather see me in person,” he said. “And if I had my druthers, I’d rather see them in person.” Online visits can have special challenges, including for patients who don’t hear or see well, he said. But those complications can be addressed.

Nancy Bennett, another resident of Helm’s Iowa nursing home, can attest to the benefits. Bennett had a video appointment with Macon on a recent morning. She told the nurse practitioner she’d been feeling stressed. “I’m 72, I’m in a nursing home, I’ve got no family around, so yeah, I’m a little depressed,” she said. “I do get sad sometimes.”

“That’s normal,” Macon assured her.

Bennett said she dislikes taking a lot of pills. Macon said she could taper some of Bennett’s medication.

In an interview afterward, Bennett said she’d gone to a clinic for mental health care in the past. That was before physical issues forced her into the nursing home, where she spends much of her time sitting in a blue recliner in her room.

If she’d had to get dressed and travel for her appointment with Macon, she said, she probably would have canceled. “There are days when I don’t want to be bothered,” she said.

But on this day, the mental health professional came to her on an iPad ― and helped Bennett feel a little better.

KHN (Kaiser Health News) is 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.

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Mobile Clinics Really Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

Kaiser Health News - Mon, 03/20/2023 - 5:00am

Nearly 12 years ago, a nonprofit centered on substance abuse prevention in Lyon County, Nevada, broadened its services to dental care.

Leaders with the Healthy Communities Coalition were shocked into action after two of their food pantry volunteers used pliers to pull each other’s abscessed teeth. The volunteers saw no other option to relieve their overwhelming pain in the small town where they lived, 40 miles southeast of Reno, because of a dearth of dental care providers.

That drastic act, said Wendy Madson, executive director for the coalition, prompted her organization to use mobile clinics to offer health and dental services in rural communities where there aren’t enough patients to support brick-and-mortar offices.

The coalition now sends a van outfitted with dental equipment to county schools to treat hundreds of students per stop a few times each year. They also host events for adults in the region. The response has been overwhelming.

“Dental is the hot ticket,” Madson said. “Everybody wants dental. Availability of those services is what runs out first in those large mobile events.”

The coalition’s mobile programs mirror efforts nationwide to dispatch services to patients experiencing gaps in the health care system, especially in rural areas.

Rural residents face more significant health care provider shortages, including dentists, compared with their counterparts in larger cities. Since the beginning of the pandemic, mobile clinics have increased access to a range of services in hard-to-reach places with sparse populations.

A recently passed law, which makes it easier for rural communities to pay for new mobile clinics, could expand this trend. In the past, clinics that serve low-income rural residents couldn’t spend federal grant money, called new access point grants, on mobile services in communities where they didn’t already have facilities.

Then last fall, Congress passed the MOBILE Health Care Act, sponsored by Sens. Jacky Rosen (D-Nev.) and Susan Collins (R-Maine), which gives federally qualified health centers — health clinics serving medically underserved areas — greater flexibility to use federal funding to create and operate mobile units.

Since 2019, the number of mobile clinics on the road has expanded, according to the National Association of Community Health Centers. Many had been used for covid-19 testing and vaccinations. And health and community organizations have started using mobile units to bring primary care, behavioral health, and reproductive services to out-of-the-way patients. The new funding pathway could soon put even more mobile health vans on the road.

For now, the law is dependent on congressional funding, and experts predict it could be at least a year before health centers can access the grant money.

More than 2,000 health center advocates went to Washington, D.C., in early March to ask lawmakers to support multiyear grant funding, said Amy Simmons Farber, associate vice president of media relations for the National Association of Community Health Centers.

Once funded, the regulatory shift will allow health centers to collaborate with independent organizations like Madson’s Health Communities Coalition in Nevada to expand services in underserved regions. Because the coalition is not a federally qualified health center, it has relied on a mix of other federal and state grants.

Nearly 1,400 federally qualified health centers nationwide receive federal funding for providing comprehensive health services in underserved areas. The previous requirement that health centers establish brick-and-mortar clinics before expanding mobile clinics prevented many from applying, said Steve Messinger, policy director for the Nevada Primary Care Association. It was burdensome and costly for health centers.

But in rural areas with small populations, served well by mobile clinics, it wouldn’t make sense to first establish a building with a full-time provider, he said. That could eat up the budget of a federally qualified health center.

While health center advocates lobby Congress for base funding, the Healthy Communities Coalition is forging ahead with three dental events this year funded by a grant from the Health Resources and Services Administration, part of the Department of Health and Human Services.

At the first medical outreach event the coalition organized in 2012 in Lyon County, where 61,400 residents are spread across more than 2,000 square miles, more than 200 people showed up to receive free care and 150 teeth were pulled, Madson said. Since then, the organization has hosted several events a year — except in 2020, when the pandemic paused work.

Many of the dental events are school-focused and provide children with such services as screenings, X-rays, sealings, varnish, and cleanings. But an overwhelming need for care also exists among area adults, said Madson, because Medicare and Nevada’s Medicaid do not include comprehensive dental coverage for adults. It’s harder to fund those events, she said.

Of the five communities in Lyon County, at least one, Silver Springs, does not have a single dentist. There are 10 dentists total in Fernley and Dayton, communities with a combined population of 38,600 people, but only two of those practices accept Medicaid, which covers low-income people younger than 21 and limited dental services for adults.

Traci Rothman, who manages the coalition’s food pantries, said the dental outreach events made a difference for her 29-year-old son, who moved to Silver Springs last year. He went to two mobile clinics to receive free care, which Rothman said was a big relief because he’s uninsured and needed dental care badly.

“Otherwise, you’re going to somebody that you’re paying cash,” she said. “Oftentimes I cannot pay, honestly; it’s just out of reach for some people, or most people … in rural areas.”

Madson said the coalition stepped in to help a young student in desperate need of a root canal. The coalition is helping the girl’s family apply for Medicaid or Nevada Check Up, the state Children’s Health Insurance Program, and is paying $1,600 to cover the service with federal grant money. Another student had to be referred to several specialists before she had her decayed baby teeth surgically removed and received restorative treatment for adult teeth that had begun to decay.

“Her mom was so thankful, she was in tears,” Madson said. “She told me that her daughter woke up without instant pain for the first time in years.”

Madson said her organization has enough grant funding for three events through May, but she hopes the MOBILE Health Care Act will help expand services. Besides dental care, the group provides primary care mobile clinics for immigrant workers in Yerington, a small town in an agricultural region about 70 miles southeast of Reno.

Sara Rich, CEO of Choptank Community Health in Maryland, said she shares Madson’s hope.

Choptank serves five counties in Maryland, including small towns between the Chesapeake Bay and the Delmarva Peninsula. Amid the pandemic, the health organization struck an unlikely partnership with a car dealership and used federal covid relief money to buy a Ford Transit cargo van for mobile clinics.

Choptank used its new van to provide vaccines but has since started using it to provide primary care to immigrant workers and dental services to children at 36 schools. The mobile clinics have been so successful that the health center is working on purchasing more vans to expand its services.

Rich said the mobile clinics are “breaking down barriers that a lot of us have been working on for a long time.”

Among the new services Choptank seeks to provide are behavioral health, preventing and treating substance use disorders, and skin screenings for people working on the shores of Maryland.

“Flexibility has been a theme over the last few years,” Rich said. “I think this MOBILE Health Care Act will help us do that even more into the future.”

KHN (Kaiser Health News) is 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.

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Judge Signals He Could Rule to Halt Sales of Common Abortion Pill

Kaiser Health News - Mon, 03/20/2023 - 5:00am

During a four-hour hearing last week that could eliminate nationwide access to a common and widely used abortion pill, federal Judge Matthew Kacsmaryk, of the Northern District of Texas, signaled his conservative Christian beliefs early and often.

Speaking from the bench in a courtroom in Amarillo, Texas, Kacsmaryk repeatedly used language that mimicked the vocabulary of anti-abortion activists. It also reflected the wording of the lawyers seeking to overturn the FDA’s two-decade-old approval of mifepristone, one of the drugs in the two-pill regimen approved for early pregnancy termination.

Each time a lawyer from the Department of Justice, representing the FDA, referred to “medication abortion,” Kacsmaryk returned to the language of conservative Christian activists, using monikers like “chemical abortion” and “mail-in abortion,” phrases at odds with conventional medical terminology.

The stakes in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, are high: Abortion rights advocates fear that Kacsmaryk, an appointee of then-President Donald Trump and a former lawyer at the First Liberty Institute, a conservative Christian legal group, could rule within days to force manufacturers to pull mifepristone from the market nationwide. If that happens, clinics and obstetricians and gynecologists across the country will be able to prescribe only misoprostol, the second drug in the two-pill regimen, for miscarriages and early abortion care. Misoprostol is still extremely safe but less effective and comes with more side effects.

The ruling would be unprecedented in the history of approved drugs and could affect the health care of millions of women, even those in states where abortion is still legal.

“One conservative judge is impacting the rights of women in California and New York,” said Greer Donley, an associate professor of law at the University of Pittsburgh Law School and expert on reproductive health law. “The endgame is to stop as many abortions as possible by any means necessary.”

When the conservative majority on the Supreme Court eliminated the federal right to abortion, Justice Brett Kavanaugh, a Catholic, wrote that the court was not outlawing abortion throughout the United States. “On the contrary,” Kavanaugh wrote, “the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process.”

But in the nine months since the announcement of the decision in Dobbs v. Jackson Women’s Health Organization, Christian legal groups have made their strategy clear: eliminate abortion nationwide by filing lawsuits in federal courts that make scientific claims, unsupported by mainstream medical organizations, to raise doubts about the safety of abortion pills and contraception.

These legal decisions, which conservatives might once have decried as “judicial activism,” are partially necessary because abortion rights continually poll positively, with voters even in solidly conservative states like Kansas and Kentucky refusing to enact bans.

“After Dobbs, there have been more and more efforts to move things away from the popular majority and into the hands of judges like Kacsmaryk,” said Mary Ziegler, a law professor and abortion historian at the University of California-Davis School of Law. “Because voters are not sold on fetal rights and because the only way to a national ban on abortion is likely to come from the conservative courts,” she said.

Ziegler added of anti-abortion campaigners, “They don’t want solutions that work only in Tennessee and Texas.”

The strategy of casting doubt on established and accepted science is not new in conservative circles, nor is it limited to abortion.

For decades, conservative Christian legal groups have introduced scientific uncertainty where there had been none: Claims that abortion causes breast cancer or infertility are unsupported by medical and scientific research but nevertheless made their way into state laws, requiring physicians in certain states to tell patients about risks from abortion that do not exist.

And in a recent opinion that ended birth control access for teens without parental consent in Texas, the same judge as in the mifepristone case — Kacsmaryk — exaggerated the health risks of prescription birth control in his decision, asserting that states have an interest in protecting the health of girls.

“Several popular methods of birth control carry serious side effects,” Kacsmaryk wrote, later quoting from Planned Parenthood educational material that read, “Complications are rare, but they can be serious. In very rare cases, they can lead to death.”

That case, Deanda v. Becerra, was filed by a Christian father who cited religious objections to a federal family planning program. And in the mifepristone case, fundamentalist Christian groups have argued that the drug is unsafe, despite ample research and decades of use testifying to the contrary.

Alliance Defending Freedom, which describes itself as the world’s largest legal organization committed to protecting “God’s design for marriage and family,” is pushing to outlaw abortion pills. Erik Baptist, an attorney for the group, said in a statement following the March 15 hearing that the “the FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground.”

He added, “It’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”

Conservative legal groups like ADF have been savvy about exploiting small wins in the courts and building on them, such as the 2007 decision Gonzales v. Carhart, which upheld a federal ban on a rarely used method of abortion.

The decision had minimal practical impact, as the procedure in question was rarely performed, but it established an important legal principle: When scientific uncertainty arises in legal disputes — is a medical procedure, device, or medication safe or not? — legislatures get to decide.

“The court said when there is scientific uncertainty the tiebreaker goes to the legislature,” said Ziegler.

But there is little question that mifepristone is safe: More than 5.6 million women have successfully used medication abortion since 2000, according to the FDA. In 2008, the Government Accountability Office investigated the FDA’s approval of mifepristone and concluded the process was consistent with FDA regulations.

In the courtroom, Baptist acknowledged that no court had ever ordered the FDA to remove a drug from the market over the agency’s objections, and legal observers say there remains a huge question whether the court can order the secretary of the Department of Health and Human Services, who oversees the FDA, to do so.

But Laurie Sobel, an associate director for women’s health policy at KFF, who listened to the hearing in a Dallas courtroom, said anti-abortion attorneys argued that the mailing of abortion medications strips states of their ability to protect women and children. (The hearing, which Kacsmaryk did not, initially, publicly announce, was not streamed to the public, and the court has yet to release a transcript.)

But Jessica Ellsworth, an attorney representing Danco Laboratories, a manufacturer of mifepristone, told the court that abortion remained legal in all states because it was allowed for preventing a patient’s death or serious bodily injury. Using mifepristone is the safest method of abortion, she argued, noting the judge’s decision in the case could ban it in every state.

“If Kavanaugh said, ‘We’re going to send it back to the states to be decided by their elected representatives,’ this is the exact opposite,” said Donley.

Kacsmaryk appeared ready to grant a preliminary injunction in favor of anti-abortion groups, asking ADF’s Baptist what kind of remedy he was seeking.

Baptist responded, “The court has an interest in preventing dangerous drugs from entering the marketplace.” He added, “Any relief you grant must be complete. The harm of chemical drugs knows no bound.”

KHN (Kaiser Health News) is 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.

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California eligió a la compañía de genéricos Civica para producir insulina de bajo costo

Kaiser Health News - Sat, 03/18/2023 - 12:37pm

SACRAMENTO, CA. — El gobernador Gavin Newsom anunció el sábado 18 de marzo que se había seleccionado al fabricante de medicamentos genéricos Civica, con sede en Utah, para producir insulina de bajo costo para el estado, una medida sin precedentes que cumple su promesa de poner al gobierno estatal en competencia directa con las versiones de marca de las farmaceúticas que dominan el mercado.

“La gente no debería verse obligada a endeudarse para obtener recetas que salvan vidas”, dijo Newsom. “Los californianos tendrán acceso a algunas de las insulinas más económicas disponibles, lo que les ayudará a ahorrar miles de dólares cada año”.

El contrato, con un costo inicial de $50 millones que Newsom y los legisladores demócratas aprobaron el año pasado, estipula que Civica produzca insulina de marca estatal y ponga el medicamento a disposición de cualquier californiano que lo necesite, por correo y en las farmacias locales, independientemente de si tenga o no seguro de salud.

Y la insulina es solo el comienzo. Newsom dijo que el estado también buscará producir naloxona, el fármaco que revierte las sobredosis de opioides.

Allan Coukell, vicepresidente sénior de políticas públicas de Civica, le dijo a California Healthline que el fabricante de medicamentos sin fines de lucro también está en conversaciones con la administración de Newsom para producir potencialmente otros medicamentos genéricos. Pero se negó a dar más detalles y dijo que la compañía se enfoca primero en hacer que la insulina económica esté ampliamente disponible.

“Estamos muy entusiasmados con esta asociación con el estado de California”, dijo Coukell. “No buscamos tener el 100% del mercado, pero sí queremos que el 100% de las personas tenga acceso a insulina a un precio justo”.

A medida que los costos de la insulina para los consumidores se han disparado, los legisladores y activistas demócratas han pedido a la industria que los controle. Apenas unas semanas después que el presidente Joe Biden atacara a las grandes farmacéuticas por aumentar los precios de la insulina, los tres fabricantes de medicamentos que controlan ese mercado, Eli Lilly and Co., Novo Nordisk y Sanofi, anunciaron que reducirían drásticamente los precios de lista de algunos productos.

Newsom, quien anteriormente acusó a la industria farmacéutica de estafar a los californianos con “precios altísimos”, argumentó que el lanzamiento de la marca de genéricos estatal, CalRx, sumará competencia y ejercerá presión sobre la industria.

Funcionarios de la administración no dijeron cuándo estarían disponibles los productos de insulina de California, pero expertos dicen que podría ser tan pronto como en 2025. Coukell remarcó que el medicamento de marca estatal aún requerirá la aprobación de la Administración de Drogas y Alimentos (FDA), lo que puede demorar unos 10 meses.

La Pharmaceutical Research and Manufacturers of America, que cabildea en nombre de las empresas de marca, criticó la medida de California. Reid Porter, director senior de asuntos públicos estatales de PhRMA, dijo que Newsom solo “quiere sumar puntos políticos”.

“Si el gobernador quiere tener un impacto significativo en lo que los pacientes pagan por las insulinas y otros medicamentos, debería expandir su enfoque a otros en el sistema que a menudo hace que los pacientes paguen más por los medicamentos”, dijo Porter, culpando a las empresas intermediarias, conocidas como administradores de beneficios de farmacia, que negocian con los fabricantes en nombre de las aseguradoras para reembolsos y descuentos.

La Pharmaceutical Care Management Association, que representa a estos administradores, argumentó a su vez que son las compañías farmacéuticas las culpables de los altos precios.

Expertos en precios dicen que los administradores de beneficios farmacéuticos y los fabricantes de medicamentos comparten la culpa.

Funcionarios de la administración Newsom dicen que los costos inflados de la insulina obligan a algunos a pagar hasta $300 por vial o $500 por una caja de plumas inyectables, y que demasiados californianos con diabetes se saltan o racionan sus medicamentos. Esto puede provocar ceguera, amputaciones y afecciones potencialmente mortales, como enfermedades cardíacas e insuficiencia renal. Casi el 10% de los adultos de California tienen diabetes.

Civica está desarrollando tres tipos de insulina genérica, conocida como biosimilar, que estarán disponibles tanto en viales como en plumas inyectables. Se espera que sean intercambiables con productos de marca, incluidos Lantus, Humalog y NovoLog. Coukell dijo que la compañía pondría a disposición el medicamento por no más de $30 por vial, o $55 por cinco plumas inyectables.

Newsom dijo que la insulina estatal le ahorrará a muchos pacientes entre $2,000 y $4,000 al año, aunque siguen sin respuesta preguntas críticas sobre cómo California pondrá los productos en manos de los consumidores, incluida la forma en que persuadiría a las farmacias, las aseguradoras y los minoristas para que distribuyan los medicamentos.

El año pasado, Newsom también obtuvo $50 millones en capital inicial para construir una instalación para fabricar insulina; Coukell dijo que Civica está explorando la construcción de una planta en California.

El movimiento de California, aunque nunca antes lo había intentado un gobierno estatal, podría verse afectado por las recientes decisiones de la industria para reducir los precios de la insulina. En marzo, Lilly, Novo Nordisk y Sanofi se comprometieron a reducir los precios. Con Lilly ofreciendo un vial a $25 por mes, Novo Nordisk prometió importantes reducciones que llevarían el precio de un vial genérico particular a $48, y Sanofi fijó un vial a $64.

La oficina del gobernador dijo que le costará al estado $30 por vial para fabricar y distribuir insulina y se venderá a ese precio. Si lo hace, argumenta la administración, “evitará el atroz cambio de costos que ocurre en los juegos de precios farmacéuticos tradicionales”.

Expertos en precios de medicamentos dijeron que la producción de genéricos en California podría reducir aún más los costos de la insulina y beneficiar a las personas con planes médicos con deducibles altos o sin seguro.

“Este es un movimiento extraordinario en la industria farmacéutica, no solo para la insulina, sino potencialmente para todo tipo de medicamentos”, dijo Robin Feldman, profesor de la Facultad de Derecho de la Universidad de California en San Francisco. “Es una industria muy difícil de quebrantar, pero California está lista para hacer precisamente eso”.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

KHN (Kaiser Health News) is 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.

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California Picks Generic Drug Company Civica to Produce Low-Cost Insulin

Kaiser Health News - Sat, 03/18/2023 - 9:01am

SACRAMENTO, Calif. — Gov. Gavin Newsom on Saturday announced the selection of Utah-based generic drug manufacturer Civica to produce low-cost insulin for California, an unprecedented move that makes good on his promise to put state government in direct competition with the brand-name drug companies that dominate the market.

“People should not be forced to go into debt to get lifesaving prescriptions,” Newsom said. “Californians will have access to some of the most inexpensive insulin available, helping them save thousands of dollars each year.”

The contract, with an initial cost of $50 million that Newsom and his fellow Democratic lawmakers approved last year, calls for Civica to manufacture state-branded insulin and make the lifesaving drug available to any Californian who needs it, regardless of insurance coverage, by mail order and at local pharmacies. But insulin is just the beginning. Newsom said the state will also look to produce the opioid overdose reversal drug naloxone.

Allan Coukell, Civica’s senior vice president of public policy, told KHN that the nonprofit drugmaker is also in talks with the Newsom administration to potentially produce other generic medications, but he declined to elaborate, saying the company is focused on making cheap insulin widely available first.

“We are very excited about this partnership with the state of California,” Coukell said. “We’re not looking to have 100% of the market, but we do want 100% of people to have access to fair insulin prices.”

As insulin costs for consumers have soared, Democratic lawmakers and activists have called on the industry to rein in prices. Just weeks after President Joe Biden attacked Big Pharma for jacking up insulin prices, the three drugmakers that control the insulin market — Eli Lilly and Co., Novo Nordisk, and Sanofi — announced they would slash the list prices of some products.

Newsom, who has previously accused the pharmaceutical industry of gouging Californians with “sky-high prices,” argued that the launch of the state’s generic drug label, CalRx, will add competition and apply pressure on the industry. Administration officials declined to say when California’s insulin products would be available, but experts say it could be as soon as 2025. Coukell said the state-branded medication will still require approval from the FDA, which can take roughly 10 months.

The Pharmaceutical Research and Manufacturers of America, which lobbies on behalf of brand-name companies, blasted California’s move. Reid Porter, senior director of state public affairs for PhRMA, said Newsom just “wants to score political points.”

“If the governor wants to impact what patients pay for insulins and other medicines meaningfully, he should expand his focus to others in the system that often make patients pay more than they do for medicines,” Porter said, blaming pharmaceutical go-between companies, known as pharmacy benefit managers, that negotiate with manufacturers on behalf of insurers for rebates and discounts on drugs.

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers argued in turn that it’s pharmaceutical companies that are to blame for high prices.

Drug pricing experts, however, say pharmacy benefit managers and drugmakers share the blame.

Newsom administration officials say that inflated insulin costs force some to pay as much as $300 per vial or $500 for a box of injectable pens, and that too many Californians with diabetes skip or ration their medication. Doing so can lead to blindness, amputations, and life-threatening conditions such as heart disease and kidney failure. Nearly 10% of California adults have diabetes.

Civica is developing three types of generic insulin, known as a biosimilar, which will be available both in vials and in injectable pens. They are expected to be interchangeable with brand-name products including Lantus, Humalog, and NovoLog. Coukell said the company would make the drug available for no more than $30 a vial, or $55 for five injectable pens.

Newsom said the state’s insulin will save many patients $2,000 to $4,000 a year, though critical questions about how California would get the products into the hands of consumers remain unanswered, including how it would persuade pharmacies, insurers, and retailers to distribute the drugs.

Last year, Newsom also secured $50 million in seed money to build a facility to manufacture insulin; Coukell said Civica is exploring building a plant in California.

California’s move, though never been tried by a state government, could be blunted by recent industry decisions to lower insulin prices. In March, Lilly, Novo Nordisk, and Sanofi vowed to cut prices, with Lilly offering a vial at $25 per month; Novo Nordisk promising major reductions to bring the price of a particular generic vial to $48; and Sanofi also slashing prices, with one vial pegged at $64.

The governor’s office said it will cost the state $30 per vial to manufacture and distribute insulin and it will be sold at that price. Doing so, the administration argues, “will prevent the egregious cost-shifting that happens in traditional pharmaceutical price games.”

Drug pricing experts said generic production in California could further lower costs for insulin, and benefit people with high-deductible health insurance plans or no insurance.

“This is an extraordinary move in the pharmaceutical industry, not just for insulin but potentially for all kinds of drugs,” said Robin Feldman, a professor at the University of California College of the Law-San Francisco. “It’s a very difficult industry to disrupt, but California is poised to do just that.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is 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.

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Journalists Discuss Medicaid Unwinding and Clawbacks

Kaiser Health News - Sat, 03/18/2023 - 5:00am

KHN correspondent Rachana Pradhan untangled Medicaid unwinding on PBS’ “PBS News Weekend” on March 11.

KHN senior editor Andy Miller discussed virtual visits on WUGA’s “The Georgia Health Report” on March 10.

KHN rural editor and correspondent Tony Leys discussed how Medicaid clawbacks drain patients’ estates after they die on NPR’s “Weekend Edition Sunday” on March 5.

KHN (Kaiser Health News) is 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.

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Temp Nurses Cost Hospitals Big During Pandemic. Lawmakers Are Now Mulling Limits.

Kaiser Health News - Fri, 03/17/2023 - 5:00am

To crack down on price gouging, proposed legislation in Missouri calls for allowing felony charges against health care staffing agencies that substantially raise their prices during a declared emergency.

A New York bill includes a cap on the amount staffing agencies can charge health care facilities. And a Texas measure would allow civil penalties against such agencies.

These proposed regulations — and others in at least 11 more states, according to the American Staffing Association industry trade group — come after demand for travel nurses, who work temporary assignments at different facilities, surged to unprecedented levels during the worst of the covid-19 pandemic.

Hospitals have long used temporary workers, who are often employed by third-party agencies, to help fill their staffing needs. But by December 2021, the average weekly travel nurse pay in the country had soared to $3,782, up from $1,896 in January 2020, according to a Becker’s Hospital Review analysis of data from hiring platform Vivian Health. That platform alone listed over 645,000 active travel nurse jobs in the final three months of 2022.

Some traveling intensive care unit nurses commanded $10,000 a week during the worst of the pandemic, prompting burned-out nurses across the country to leave their hospital staff jobs for more lucrative temporary assignments. Desperate hospitals that could afford it offered signing bonuses as high as $40,000 for nurses willing to make multiyear commitments to join their staff instead.

The escalating costs led hospitals and their allies around the country to rally against what they saw as price gouging by staffing agencies. In February 2021, the American Hospital Association urged the Federal Trade Commission to investigate “anticompetitive pricing” by agencies, and, a year later, hundreds of lawmakers urged the White House to do the same.

No substantial federal action has occurred, so states are trying to take the next step. But the resulting regulatory patchwork could pose a different challenge to hospitals in states with rate caps or other restrictive measures, according to Hannah Neprash, a University of Minnesota health care economics professor. Such facilities could find it difficult to hire travel nurses or could face a lower-quality hiring pool during a national crisis than those in neighboring states without such measures, she said.

For example, Massachusetts and Minnesota already had rate caps for temporary nurses before the pandemic but raised and even waived their caps for some staffing agencies during the crisis.

And any new restrictions may meet stiff resistance, as proposed rate caps did in Missouri last year.

As the covid omicron variant wave began to subside, Missouri legislators considered a proposal that would have set the maximum rate staffing agencies could charge at 150% of the average wage rate of the prior three years plus necessary taxes.

The Missouri Hospital Association, a trade group that represents 140 hospitals across the state, supported the bill as a crackdown on underhanded staffing firms, not on nurses being able to command higher wages, spokesperson Dave Dillon said.

“During the pandemic there were staffing companies who were making a lot of promises and not necessarily delivering,” Dillon said. “It created an opportunity for both profiteering and for bad actors to be able to play in that space.”

Nurses, though, decried what they called government overreach and argued the bill could make the state’s existing nursing shortage worse.

Theresa Newbanks, a nurse practitioner, asked legislators to imagine the government attempting to dictate how much a lawyer, electrician, or plumber could make in Missouri. “This would never be allowed,” she testified to the committee considering the bill. “Yet, this is exactly what is happening, right now, to nurses.”

Another of the nearly 30 people who testified against the bill was Michelle Hall, a longtime nurse and hospital nursing leader who started her own staffing agency in 2021, in part, she said, because she was tired of seeing her peers leave the industry over concerns about unsafe staffing ratios and low pay.

“I felt like I had to defend my nurses,” Hall later told KHN. Her nurses usually receive about 80% of the amount she charges, she said.

Typically about 75% of the price charged by a staffing agency to a health care facility goes to costs such as salary, payroll taxes, workers’ compensation programs, unemployment insurance, recruiting, training, certification, and credential verification, said Toby Malara, a vice president at the American Staffing Association trade group.

He said hospital executives have, “without understanding how a staffing firm works,” wrongly assumed price gouging has been occurring. In fact, he said many of his trade group’s members reported decreased profits during the pandemic because of the high compensation nurses were able to command.

While Missouri lawmakers did not pass the rate cap, they did make changes to the regulations governing staffing agencies, including requiring them to report the average amounts charged per health care worker for each personnel category and the average amount paid to those workers. Those reports will not be public, although the state will use them to prepare its own aggregate reports that don’t identify individual agencies. The public comment period on the proposed regulations was scheduled to begin March 15.

Hall was not concerned about the reporting requirements but said another of the changes might prompt her to close shop or move her business out of state: Agencies will be barred from collecting compensation when their employees get recruited to work for the facility where they temp.

“It doesn’t matter all the money that I have put out prior, to onboard and train that person,” Hall said.

Dillon called that complaint “pretty rich,” noting that agencies routinely recruit hospital staff members by offering higher pay. “Considering the premium agencies charge for staff, I find it hard to believe that this risk isn’t built into their business model,” he said.

Of course, as the pandemic has waned, the demand for travel nursing has subsided. But pay has yet to drop back to pre-pandemic levels. Average weekly travel nurse pay was $3,077 in January, down 20% year over year but still 62% higher in January 2020, according to reporting on Vivian Health data by Becker’s.

With the acute challenges of the pandemic behind hospitals, Dillon said, health system leaders are eyeing proactive solutions to meet their ongoing workforce challenges, such as raising pay and investing in the nursing workforce pipeline.

A hospital in South Carolina, for example, is offering day care for staffers’ children to help retain them. California lawmakers are considering a $25-per-hour minimum wage for health care workers. And some hospitals have even created their own staffing agencies to reduce their reliance on third-party agencies.

But the momentum to directly address high travel nurse rates hasn’t gone away, as evidenced by the legislative push in Missouri this year.

The latest proposal would apply to certain agencies if a “gross disparity” exists between the prices they charge during an emergency and what they charged prior to it or what other agencies are currently charging for similar services and if their earnings are at least 15% higher than before the emergency.

Malara said he doesn’t have much of a problem with this year’s bill because it gives agencies the ability to defend their practices and pricing.

Kentucky last year applied its existing price gouging rules to health care staffing agencies. The rules, which set criteria for acceptable prices, allow increases driven by higher labor costs. Malara said if the Missouri bill gains momentum he will point its sponsor to that language and ask her to clarify what constitutes a “gross disparity” in prices.

The sponsor of the bill, Missouri state Sen. Karla Eslinger, a Republican, did not respond to requests for comment on the legislation.

Hall said she is opposed to any rate caps but is ambivalent about Missouri’s new proposal. She said she saw agencies raising their prices from $70 an hour to over $300 while she worked as a hospital nursing leader at the height of the pandemic.

“All these agencies that were price gouging,” Hall said, “all they were doing was putting that money in their own pockets. They weren’t doing anything different or special for their nurses.”

KHN (Kaiser Health News) is 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.

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California’s Covid Misinformation Law Is Entangled in Lawsuits, Conflicting Rulings

Kaiser Health News - Fri, 03/17/2023 - 5:00am

Gov. Gavin Newsom may have been prescient when he acknowledged free speech concerns as he signed California’s covid misinformation bill last fall. In a message to lawmakers, the governor warned of “the chilling effect other potential laws may have” on the ability of doctors to speak frankly with patients but expressed confidence that the one he was signing did not cross that line.

Yet the law — meant to discipline doctors who give patients false information about covid-19 — is now in legal limbo after two federal judges issued conflicting rulings in recent lawsuits that say it violates free speech and is too vague for doctors to know what it bars them from telling patients.

In two of the lawsuits, Senior U.S. District Judge William Shubb in Sacramento issued a temporary halt on enforcing the law, but it applies only to the plaintiffs in those cases. Shubb said the law was “unconstitutionally vague,” in part because it “fails to provide a person of ordinary intelligence fair notice of what is prohibited.” His ruling last month clashed with one handed down in Santa Ana in December; in that case, U.S. District Judge Fred Slaughter refused to halt the law and said it was “likely to promote the health and safety of California covid-19 patients.”

The legal fight in the nation’s most populous state is to some extent a perpetuation of the pandemic-era tussle pitting supporters of public health guidelines against groups and individuals who resisted masking orders, school shutdowns, and vaccine mandates.

California’s covid misinformation law, which took effect Jan. 1, is being challenged by vaccine skeptics and civil liberties groups. Among those suing to get the law declared unconstitutional is a group founded by Robert F. Kennedy Jr., who has questioned the science and safety of vaccines for years.

But doubts about the law are not confined to those who have battled the scientific mainstream.

Dr. Leana Wen, a health policy professor at George Washington University who previously served as president of Planned Parenthood and as Baltimore’s health commissioner, wrote in an op-ed a few weeks before Newsom signed the law that it would exert “a chilling effect on medical practice, with widespread repercussions that could paradoxically worsen patient care.”

The Northern California affiliate of the American Civil Liberties Union has weighed in against the law on free speech grounds, though the national organization has affirmed the constitutionality of covid vaccine mandates.

“If doctors are scared of losing their licenses for giving advice that they think is helpful and appropriate, but they don’t quite know what the law means, they will be less likely to speak openly and frankly with their patients,” said Hannah Kieschnick, an attorney with the ACLU of Northern California.

The law establishes that doctors who give false information about covid to patients are engaging in unprofessional conduct, which could subject them to discipline by the Medical Board of California or the Osteopathic Medical Board of California.

Proponents of the law sought to crack down on what they believe are the most clear-cut cases: Doctors who tout treatments such as ivermectin, an anti-parasitic agent that is unproven as a covid treatment and can be dangerous; who exaggerate the risk of getting vaccinated compared with the dangers of the disease; or who spread unfounded theories about the vaccines, including that they can cause infertility or harm DNA.

But the law lacks such specifics, defining misinformation only as “false information that is contradicted by contemporary scientific consensus contrary to the standard of care.”

Michelle Mello, a professor of law and health policy at Stanford University, said the wording is confusing.

“On a matter like covid, science is changing all the time, so what does it mean to say there is scientific consensus?” she asked. “To me, there are lots of examples of statements that clearly, with no vagueness involved, meet the definition of the kind of conduct that the legislature was going after. The problem is that there are all kinds of other hypothetical things that people can say that don’t clearly violate it.”

Dr. Christine Cassel, a professor of medicine at the University of California-San Francisco, said she expects the law to be applied only in the most flagrant cases. “I trust scientists enough to know where there’s a legitimate dispute,” she said.

Cassel’s view mirrors Newsom’s rationale for signing the legislation despite his awareness of potential free speech concerns. “I am confident,” he wrote in his message to lawmakers, “that discussing emerging ideas or treatments including the subsequent risks and benefits does not constitute misinformation or disinformation under this bill’s criteria.”

Plaintiffs in the Santa Ana case, two doctors who have sometimes diverged from public health guidelines, appealed Slaughter’s ruling allowing the law to stand. The case has been combined in the 9th U.S. Circuit Court of Appeals with another case in which a San Diego judge declined to rule on a similar request to temporarily halt the law.

Newsom spokesperson Brandon Richards said in early February that the administration would not appeal the two Sacramento cases in which Shubb issued the narrow injunction. The plaintiffs’ lawyers had expected the state to appeal the decision, thinking all four lawsuits would then be decided by the appeals court, providing greater clarity for all parties.

Richard Jaffe, lead attorney in one of the Sacramento cases — brought by a doctor, Kennedy’s Children’s Health Defense, and a group called Physicians for Informed Consent — said Newsom’s decision not to appeal is “just going to increase the level of chaos in terms of who the law applies to.”

But the Newsom administration has decided to wait for the appeals court to rule on the other two judges’ decisions that left the law intact for now.

Jenin Younes, a lawyer with the New Civil Liberties Alliance who is lead counsel in the other Sacramento case in which Shubb issued his injunction, said Newsom may be calculating that “you’re in a stronger position going up on a win than on a loss.”

A victory for Newsom in the appeals court, Jaffe and others said, could dampen the impact of the two Sacramento cases.

Opponents of California’s covid misinformation law question why it is needed at all, since the medical boards already have authority to discipline doctors for unprofessional conduct. Yet only about 3% of the nearly 90,000 complaints the Medical Board of California received over a decade resulted in doctors being disciplined, according to a 2021 investigation by the Los Angeles Times.

That could be good news for doctors who worry the new law could constrain their ability to advise patients.

“I don’t see medical boards being particularly vigorous in policing physicians’ competence in general,” said Stanford’s Mello. “You have to be really bad to get their attention.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is 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.

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Judging the Abortion Pill

Kaiser Health News - Thu, 03/16/2023 - 3:00pm
The Host Julie Rovner KHN @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KHN’s 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.

This week, the eyes of the nation are on Texas, where a federal judge who formerly worked for a conservative Christian advocacy group is set to decide whether the abortion pill mifepristone can stay on the market. Mifepristone is half of a two-pill regimen that now accounts for more than half of the abortions in the United States.

Meanwhile, Novo Nordisk, another of the three large drug companies that dominate the market for diabetes treatments, has announced it will cut the price of many of its insulin products. Eli Lilly announced its cuts early this month. But the push for more affordable insulin from activists and members of Congress is not the only reason for the change: Because of quirks in the way the drug market works, cutting prices could actually save the companies money in the long run.

This week’s panelists are Julie Rovner of KHN, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.

Panelists Jessie Hellmann CQ Roll Call @jessiehellmann Read Jessie's stories Sarah Karlin-Smith Pink Sheet @SarahKarlin Read Sarah's stories Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories

Among the takeaways from this week’s episode:

  • The federal judge examining the decades-old approval of mifepristone could issue a decision at any time after a hearing largely behind closed doors, during which he appeared open to restricting access to the drug.
  • Democratic governors seek to counter the chill of Republican states’ warnings to pharmacies about distributing mifepristone, and a separate lawsuit in Texas seeks to set a precedent for punishing people who aren’t medical providers for assisting someone in obtaining an abortion.
  • In pandemic news, Congress is moving forward with legislation that would force the Biden administration to declassify intelligence related to the origins of covid-19, while the editor of Cochrane Reviews posted a clarification of its recently published masking study, noting it is “inaccurate” to say it found that masks are not effective.
  • Top federal health officials sent an unusual letter to Florida’s surgeon general, warning that his embrace of vaccination misinformation is harmful, even deadly, to Americans. While covid vaccines come with some risk of negative health effects, contracting covid carries a higher risk of poor outcomes.
  • Novo Nordisk’s announcement that it will cut insulin prices puts pressure on Sanofi, the remaining insulin maker that has yet to adjust its prices.
  • The Veterans Health Administration will cover Leqembi, a new Alzheimer’s drug. The decision comes as Medicare considers whether it will also cover the drug. Experts caution that new drugs shaking up the weight-loss market could prove costly for Medicare.
  • Washington is eyeing changes to federal rules that would affect the practice of medicine. One change would force health plans to speed up “prior authorization” decisions by health insurers and increase transparency around denials, which supporters say would help patients better access needed care. Another proposal would ban noncompete clauses in contracts, including in health care. Arguments for and against the change both cite the issue of physician burnout — though they disagree on whether the ban would make the problem better or worse.

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

Julie Rovner: “Tradeoffs” podcast’s “The Conservative Clash Over Abortion Bans,” by Alice Miranda Ollstein and Dan Gorenstein

Alice Miranda Ollstein: Politico’s “Sharpton Dodges the Spotlight on Latest Push to Ban Menthol Cigarettes,” by Julia Marsh

Sarah Karlin-Smith: Allure’s “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry,” by Elizabeth Siegel and Deanna Pai

Jessie Hellmann: The New York Times’ “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs,” by Christina Jewett and Ellen Gabler

Also mentioned in this week’s podcast:

Credits Francis Ying Audio producer Emmarie Huetteman Editor

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KHN (Kaiser Health News) is 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.

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Estados Unidos sigue siendo uno de los países con más partos prematuros. ¿Se puede solucionar?

Kaiser Health News - Thu, 03/16/2023 - 12:31pm

El segundo embarazo de Tamara Etienne estuvo lleno de riesgos y preocupaciones desde el principio, exacerbado porque ya había sufrido un aborto espontáneo.

Como maestra de tercer grado en una escuela pública del condado de Miami-Dade, pasaba todo el día parada. Le pesaban las preocupaciones financieras, incluso teniendo seguro de salud y algo de licencia paga.

Y, como mujer negra, toda una vida de racismo la volvió desconfiada de las reacciones impredecibles en la vida diaria. Estaba agotada por el trato despectivo y desigual en el trabajo. Justamente el tipo de estrés que puede liberar cortisol, que, según estudios, aumenta el riesgo de parto prematuro.

“Lo experimento todo el tiempo, no camino sola, o lo hago con alguien a quien debo proteger. Sí, el nivel de cortisol en mi cuerpo es incontable”, expresó.

A los dos meses de embarazo, las náuseas implacables cesaron de repente. “Empecé a sentir que mis síntomas de embarazo estaban desapareciendo”, dijo. Entonces comenzó un extraño dolor de espalda.

Etienne y su esposo corrieron a la sala de emergencias, donde confirmaron que corría un grave riesgo de aborto espontáneo. Una cascada de intervenciones médicas —inyecciones de progesterona, monitoreo fetal en el hogar y reposo en cama— salvó a la niña, que nació a las 37 semanas.

Las mujeres en Estados Unidos tienen más probabilidades de dar a luz prematuramente que las de la mayoría de los países desarrollados. Esto coincide con tasas más altas de mortalidad materno infantil, miles de millones de gastos en cuidado intensivo y a menudo una vida de discapacidad para los prematuros que sobreviven.

Aproximadamente uno de cada 10 nacimientos vivos en 2021 ocurrió antes de las 37 semanas de gestación, según un informe de March of Dimes publicado en 2022. En comparación, investigaciones recientes citan tasas de nacimientos prematuros del 7,4% en Inglaterra y Gales, del 6% en Francia y del 5,8% en Suecia.

En su informe, March of Dimes encontró que las tasas de nacimientos prematuros aumentaron en casi todos los estados de 2020 a 2021. Vermont, con una tasa del 8%, tuvo la calificación más alta del país: una “A-”. Los resultados más sombríos se concentraron en los estados del sur, que obtuvieron calificaciones equivalentes a una “F”, con tasas de nacimientos prematuros del 11,5% o más.

Mississippi (15 %), Louisiana (13,5 %) y Alabama (13,1 %) fueron los estados con peor desempeño. El informe encontró que, en 2021, el 10,9% de los nacidos vivos en Florida fueron partos prematuros, por lo que obtuvo una “D”.

Desde que la Corte Suprema anulara Roe vs. Wade, muchos especialistas temen que la incidencia de nacimientos prematuros se dispare. El aborto ahora está prohibido en al menos 13 estados y estrictamente restringido en otros 12: los estados que restringen el aborto tienen menos proveedores de atención materna, según un reciente análisis de Commonwealth Fund.

Eso incluye Florida, donde los legisladores republicanos han promulgado leyes contra el aborto, incluida la prohibición de realizarlo después de las 15 semanas de gestación.

Florida es uno de los estados menos generosos cuando se trata de seguro médico público. Aproximadamente una de cada 6 mujeres en edad fértil no tiene seguro, lo que dificulta mantener un embarazo saludable. Las mujeres de Florida tienen el doble de probabilidades de morir por causas relacionadas con el embarazo y el parto que las de California.

“Me quita el sueño”, dijo la doctora Elvire Jacques, especialista en medicina materno-fetal del Memorial Hospital en Miramar, Florida.

Jacques explicó que las causas de los partos prematuros son variadas. Alrededor del 25% se inducen médicamente, por condiciones como la preeclampsia. Pero la investigación sugiere que muchos más tendrían sus raíces en una misteriosa constelación de condiciones fisiológicas.

“Es muy difícil identificar que una paciente tendrá un parto prematuro”, dijo Jacques. “Pero sí puedes identificar los factores estresantes en sus embarazos”.

Los médicos dicen que aproximadamente la mitad de todos los nacimientos prematuros debido a factores sociales, económicos y ambientales, y al acceso inadecuado a la atención médica prenatal, se pueden prevenir.

En el Memorial Hospital en Miramar, parte de un gran sistema de atención médica pública, Jacques recibe embarazos de alto riesgo referidos por otros obstetras del sur de Florida.

En la primera cita les pregunta: ¿Con quién vives? ¿Donde duermes? ¿Tienes adicciones? ¿Dónde trabajas? “Si no supiera que trabajan en una fábrica paradas cómo les podría recomendar que usaran medias de compresión para prevenir coágulos de sangre?”.

Jacques instó al gerente de una tienda a que permitiera a su empleada embarazada trabajar sentada. Persuadió a un imán para que le concediera a una futura mamá con diabetes un aplazamiento del ayuno religioso.

Debido a que la diabetes es un factor de riesgo importante, a menudo habla con los pacientes sobre cómo comer de manera saludable. Les pregunta: “De los alimentos que estamos discutiendo, ¿cuál crees que puedes pagar?”.

El acceso a una atención asequible separa a Florida de estados como California y Massachusetts, que tienen licencia familiar paga y bajas tasas de residentes sin seguro; y a Estados Unidos de otros países, dicen expertos en políticas de salud.

En países con atención médica socializada, “las mujeres no tienen que preocuparse por el costo financiero de la atención”, apuntó la doctora Delisa Skeete-Henry, jefa del departamento de obstetricia y ginecología de Broward Health en Fort Lauderdale. Y tienen licencias por maternidad pagas.

Sin embargo, a medida que aumentan los nacimientos prematuros en Estados Unidos, la riqueza no garantiza mejores resultados.

Nuevas investigaciones revelan que, sorprendentemente, en todos los niveles de ingresos, las mujeres negras y sus bebés experimentan resultados de parto mucho peores que sus contrapartes blancas. En otras palabras, todos los recursos que ofrece la riqueza no protegen a las mujeres negras ni a sus bebés de complicaciones prematuras, según el estudio, publicado por la Oficina Nacional de Investigación Económica.

Jamarah Amani es testigo de esto como directora ejecutiva de Southern Birth Justice Network y defensora de la atención de parteras y doulas en el sur de Florida. A medida que evalúa nuevos pacientes, busca pistas sobre los riesgos de nacimiento en los antecedentes familiares, análisis de laboratorio y ecografías. Y se centra en el estrés relacionado con el trabajo, las relaciones, la comida, la familia y el racismo.

“Las mujeres negras que trabajan en ambientes de alto estrés, incluso si no tienen problemas económicos, pueden enfrentar un parto prematuro”, dijo.

Recientemente, cuando una paciente mostró signos de trabajo de parto prematuro, Amani descubrió que su factura de electricidad estaba vencida, y que la empresa amenazaba con cortar el servicio. Amani encontró una organización que pagó la deuda.

De los seis embarazos de Tamara Etienne, dos terminaron en aborto espontáneo y cuatro fueron de riesgo de parto prematuro. Harta de la avalancha de intervenciones médicas, encontró una doula y una partera locales que la ayudaron en el nacimiento de sus dos hijos más pequeños.

“Pudieron guiarme a través de formas saludables y naturales para mitigar todas esas complicaciones”, dijo.

Sus propias experiencias con el embarazo dejaron un profundo impacto en Etienne. Desde entonces, ella misma se ha convertido en una doula.

KHN (Kaiser Health News) is 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.

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The US Remains a Grim Leader in Preterm Births. Why? And Can We Fix It?

Kaiser Health News - Thu, 03/16/2023 - 5:00am

Tamara Etienne’s second pregnancy was freighted with risk and worry from its earliest days — exacerbated by a first pregnancy that had ended in miscarriage.

A third-grade teacher at an overcrowded Miami-Dade County public school, she spent harried days on her feet. Financial worries weighed heavy, even with health insurance and some paid time off through her job.

And as a Black woman, a lifetime of racism had left her wary of unpredictable reactions in daily life and drained by derogatory and unequal treatment at work. It’s the sort of stress that can release cortisol, which studies have shown heighten the risk for premature labor.

“I’m experiencing it every day, not walking alone, walking with someone I have to protect,” she said. “So the level of cortisol in my body when I’m pregnant? Immeasurable.”

Two months into the pregnancy, the unrelenting nausea suddenly stopped. “I started to feel like my pregnancy symptoms were going away,” she said. Then strange back pain started.

Etienne and her husband rushed to an emergency room, where a doctor confirmed she was at grave risk for a miscarriage. A cascade of medical interventions — progesterone injections, fetal monitoring at home, and bed rest while she took months off work — saved the child, who was born at 37 weeks.

Women in the U.S. are more likely to deliver their babies prematurely than those in most developed countries. It’s a distinction that coincides with high rates of maternal and infant death, billions of dollars in intensive care costs, and often lifelong disabilities for the children who survive.

About 1 in 10 live births in 2021 occurred before 37 weeks of gestation, according to a March of Dimes report released last year. By comparison, research in recent years has cited preterm birth rates of 7.4% in England and Wales, 6% in France, and 5.8% in Sweden.

In its 2022 report card, the March of Dimes found the preterm birth rates increased in nearly every U.S. state from 2020 to 2021. Vermont, with a rate of 8%, merited the nation’s highest grade: an “A-.” The grimmest outcomes were concentrated in the Southern states, which largely earned “F” ratings, with preterm birth rates of 11.5% or higher. Mississippi (15%), Louisiana (13.5%), and Alabama (13.1%) were the worst performers. The March of Dimes report found 10.9% of live births in Florida were delivered preterm in 2021, earning the state a “D” rating.

Since the U.S. Supreme Court overturned Roe v. Wade, many maternal-fetal specialists worry that the incidence of premature birth will soar. Abortion is now banned in at least 13 states and sharply restricted in 12 others — states that restrict abortion have fewer maternal care providers than states with abortion access, according to a recent analysis by the Commonwealth Fund.

That includes Florida, where Etienne lives, and where Republican lawmakers have enacted a series of anti-abortion laws, including a ban on abortion after 15 weeks of gestation. Florida is one of the least generous states when it comes to public health insurance. About 1 in 6 women of childbearing age in Florida are uninsured, making it more difficult to begin a healthy pregnancy. Women are twice as likely to die from pregnancy and childbirth-related causes in Florida than in California.

“I lose sleep over this,” said Dr. Elvire Jacques, a maternal-fetal medicine specialist at Memorial Hospital in Miramar, Florida. “It’s hard to say, I expect [better birth outcomes] when I’m not investing anything from the beginning.”

***

The causes of preterm births are varied. About 25% are medically induced, Jacques said, when the woman or fetus is in distress because of conditions like preeclampsia, a pregnancy-related hypertensive disorder. But research suggests that far more early births are thought to be rooted in a mysterious constellation of physiological conditions.

“It’s very hard to identify that a patient will automatically have a preterm birth,” Jacques said. “But you can definitely identify stressors for their pregnancies.”

Physicians say that roughly half of all preterm births are preventable, caused by social, economic, and environmental factors, as well as inadequate access to prenatal health care. Risk factors include conditions such as diabetes and obesity, as well as more-hidden issues like stress or even dehydration.

At Memorial Hospital in Miramar, part of a large public health care system, Jacques takes on high-risk pregnancies referred from other OB-GYNs in South Florida.

When meeting a patient for the first time she asks: Who else is in your household? Where do you sleep? Do you have substance abuse issues? Where do you work? “If you don’t know that your patient works in a factory [standing] on an assembly line,” she said, “then how are you going to tell her to wear compression socks because that may help her prevent blood clots?”

Jacques has urged a store manager to let her pregnant patient sit while working. She persuaded an imam to grant a mom-to-be with diabetes a reprieve from religious fasting.

Because diabetes is a major risk factor, she often talks with patients about eating healthfully. For those who eat fast food, she asks them to try cooking at home. Instead of, “Can you pay for food?” she asks, “Of the foods we’re discussing, which one do you think you can afford?”

Access to affordable care separates Florida from states like California and Massachusetts — which have paid family leave and low rates of uninsured residents — and separates the U.S. from other countries, health policy experts say.

In countries with socialized health care, “women don’t have to worry about the financial cost of care,” said Dr. Delisa Skeete-Henry, chair of the obstetrics and gynecology department at Broward Health in Fort Lauderdale. “A lot of places have paid leave, [and pregnant patients] don’t have to worry about not being at work.”

Yet, as preterm births rise in the U.S., wealth does not ensure better pregnancy outcomes.

Startling new research shows that at every U.S. income level, Black women and their infants experience far worse birth outcomes than their white counterparts. In other words, all the resources that come with wealth do not protect Black women or their babies from preterm complications, according to the study, published by the National Bureau of Economic Research.

Jamarah Amani has seen this firsthand as executive director of the Southern Birth Justice Network and an advocate for midwifery and doula care in South Florida. As she evaluates new clients, she looks for clues about birth risks in a patient’s family history, lab work, and ultrasounds. She homes in quickly on stress related to work, relationships, food, family, and racism.

“I find Black women working in high-stress environments, even if they are not financially struggling, can face preterm birth,” she said. She develops “wellness plans” that include breathing, meditation, stretching, and walking.

Recently, when a patient showed signs of preterm labor, Amani discovered that her electricity bill was overdue and the utility was threatening to cut service. Amani found an organization to pay off the debt.

Of Tamara Etienne’s six pregnancies, two ended in miscarriage and four were threatened by preterm labor. Fed up with the onslaught of medical interventions, she found a local doula and midwife who helped guide her through the birth of her two youngest children.

“They were able to walk me through healthy, natural ways to mitigate all of those complications,” she said.

Her own pregnancy experiences left a profound impact on Etienne. She has since become a fertility doula herself.

KHN (Kaiser Health News) is 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.

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Listen to ‘Tradeoffs’: Medical Debt Delivers ‘A Shocking Amount of Misery’

Kaiser Health News - Thu, 03/16/2023 - 5:00am

The numbers that tell the story of medical debt in the U.S. are staggering: Around 100 million Americans have health care debt, and together they owe at least $140 billion. And research suggests this debt can have striking consequences on people’s financial, physical, and mental health.

In this episode of the “Tradeoffs” podcast, Dan Gorenstein talks about the pain and possible solutions to medical debt with KHN senior correspondent Noam N. Levey and UCLA researcher Wes Yin.

“About a third of people who have medical debt owe less than $1,000,” Levey said. “But a quarter of people owe, I think, more than $5,000. More than half say they’ve had to make a difficult sacrifice, like using up all their savings, moving in with friends and family, or losing their homes. So I don’t think it’s hyperbole to say that there’s a shocking amount of misery out there.”

KHN (Kaiser Health News) is 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.

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FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm

Kaiser Health News - Wed, 03/15/2023 - 7:45am

In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.

Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the AGGA, now trains dentists to use another device it has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.

The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.

Tenenbaum said that after KHN and CBS News published their report, she was contacted by “very concerned” FDA officials who said they have begun “looking into” the AGGA but have yet to determine how much legal authority the agency has to regulate it.

“The FDA is looking at what authorities they may have around this device — what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”

KHN and CBS News have reviewed online messages verifying that an FDA official has communicated with Tenenbaum about the AGGA. The FDA declined to comment on the AGGA or confirm whether it was evaluating the device.

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 others — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices.

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the device was never submitted to the FDA, which he believes doesn’t have jurisdiction over it. Tenenbaum has said the lack of registration is “incredibly problematic” because that is one method by which the FDA collects reports of a device’s negative effects.

She encouraged anyone who has witnessed complications from the AGGA to assist the FDA by submitting a report through its MedWatch portal.

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”

Victor Krauthamer, a former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency’s authority, ensuring any future action has a solid legal foundation.

Krauthamer said he expects the FDA to take regulatory action against the AGGA, including sending a warning letter to the manufacturer and potentially taking custody of the devices.

“At this point, I would be surprised if there wasn’t some sort of compliance action, such as a seizure,” Krauthamer said, adding later, “I think that’s probably where the FDA is — trying to make a case that will hold in court and won’t be thrown out.”

Jeffrey Oberlies, an attorney for AGGA manufacturer Johns Dental Laboratories, said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on the AGGA or the FDA’s interest in the device.

Galella said in his deposition he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use the appliance. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments like sleep apnea and temporomandibular joint disorder, or TMJ.

“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

Dentists across the country have drawn from Galella’s teachings on their websites, often saying the AGGA can “grow,” “remodel,” or “expand” an adult’s jaw without surgery. At least 11 of those dentists’ websites appear to have removed any mention of the AGGA since the KHN-CBS News investigation was published March 1.

“I think that’s good to hear,” said Boja Kragulj, a former professional clarinetist who has alleged in a lawsuit that the AGGA did catastrophic harm to her teeth. “I think when you take away this information from patients that are searching for the appliance and seeing these claims, that’s generally a good thing.”

Kragulj is one of at least 20 AGGA patients who have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not — and cannot — work. The plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Some allege in lawsuits they will lose teeth because of the device and added in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.

“I can take my finger now and I can literally wiggle my front teeth,” said Melanie Pappalardi, 28, who said she wore an AGGA for a year and filed a lawsuit in Indiana. “I can’t bite into absolutely anything.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, has said in a written statement that the AGGA “is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Attorneys for Galella and his company, the Facial Beauty Institute, have denied liability in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount but continues to fight allegations in the other cases. The Las Vegas Institute, which previously held AGGA classes for dentists and promoted the device on Facebook, denied liability in court and has a pending motion to end claims in one lawsuit in which it is named as a defendant.

In a sworn deposition filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson said that in 2020 he began to question the claims about what the AGGA could accomplish, then severed all ties with Galella.

However, that same year the Las Vegas Institute pivoted to the Anterior Remodeling Appliance, or ARA, according to Facebook posts by Dickerson. Dickerson has said in multiple Facebook posts over the past three years that the AGGA and ARA are very similar, including in a June 2021 post that described ARA as “almost exactly the same appliance.” He also said that most dentists associated with the Las Vegas Institute have switched to the ARA, which is made by a different dental laboratory than AGGA’s manufacturer.

“Different lab. Same thing,” Dickerson said in another Facebook post.

The Las Vegas Institute did not respond to requests for comment on the ARA. Institute attorney William Schuller has previously declined to discuss the ARA.

Dental specialists who have warned about the AGGA said they are also alarmed by the ARA.

Dr. Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, each of whom have said they’ve examined multiple patients harmed by the AGGA, said after looking at a photo of the ARA from the manufacturer’s website, it appears to be very similar to the AGGA.

“It is very similar to the AGGA,” Mandelaris said in an email. “Almost identical.”

KHN (Kaiser Health News) is 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.

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New CDC Opioid Guidelines: Too Little, Too Late for Chronic Pain Patients?

Kaiser Health News - Wed, 03/15/2023 - 6:00am

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

KHN (Kaiser Health News) is 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.

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Two Counties Square Off With California Over Mental Health Duties

Kaiser Health News - Wed, 03/15/2023 - 5:00am

SACRAMENTO, Calif. — Sacramento and Solano counties are in a standoff with the state over mental health coverage for a portion of Medicaid patients in those counties — a dispute that threatens to disrupt care for nearly 50,000 low-income residents receiving treatment for severe mental illness.

The Department of Health Care Services, which administers Medi-Cal, the state’s Medicaid program, says Sacramento and Solano counties must take over managing and providing specialty mental health care for thousands of Medi-Cal patients enrolled in Kaiser Permanente plans. It insists on shifting the responsibility because California’s remaining 56 counties already operate this way. State officials argue the switch would simplify the state’s disjointed mental health system and is needed to implement a larger transformation of Medi-Cal, an initiative known as CalAIM.

State health officials gave counties until March 15 to accept Kaiser Permanente patients, so California can properly transfer their specialty mental health care to counties by July 1. But the two counties are rebuffing the transfer, arguing that without more funding they can’t adequately care for a major influx of Medi-Cal patients with severe mental health conditions, such as schizophrenia or bipolar disorder. Medi-Cal officials, meanwhile, are threatening steep penalties or potentially terminating mental health contracts with those counties.

Local officials warn that if the state follows through with its plan, about 39,000 patients in Sacramento County and about 8,000 in Solano County could see their care disrupted and, for instance, may be forced to find a new psychiatrist.

“For someone who has schizophrenia or another serious mental health disorder, it has taken a long time to build a trusted relationship with their provider, and now they are going to see that care disrupted or have to find a different provider,” said Debbie Vaughn, assistant county administrator for Solano County. “There will be risks of people going into crisis.”

Ryan Quist, director of behavioral health services for Sacramento County, said the counties need not only more funding, but also more time to transfer the patients’ care. “The state is playing chicken with their lives,” he said.

Under state law, counties are responsible for administering and delivering specialty care to Medi-Cal patients with severe mental illness. Medi-Cal managed-care insurers are responsible for providing treatment for mild or moderate mental health conditions, such as anxiety or low-level depression.

But under a decades-old arrangement between the state and the counties of Sacramento and Solano, California has been paying Kaiser Permanente to provide all mental health care for the health care giant’s Medi-Cal enrollees. Now the state is dissolving that arrangement, forcing roughly 7,000 specialty mental health patients in those two counties to move out of Kaiser Permanente and into county-run mental health plans.

State officials argue that the two counties are legally obligated to provide care for Medi-Cal patients with severe mental illness and that county behavioral health agencies would be the ones putting patients in danger if the counties continue refusing the shift. Medi-Cal patients enrolled in health plans other than Kaiser Permanente get their specialized mental health care directly from counties.

“Sacramento and Solano counties’ failure to engage in this process places Medi-Cal members at risk of losing access to critical Medi-Cal entitlement services,” said Tony Cava, a spokesperson for the Department of Health Care Services. “DHCS will have no choice but to take action if the counties continue to refuse to fulfill their obligations.”

The state is considering sanctions or terminating the counties’ contracts, but Cava said that “contract termination is not DHCS’ preferred approach.” He declined to elaborate, adding only that the agency would “identify solutions to continue coverage” for Kaiser Permanente patients.

He said transferring patients to the counties will provide “a more consistent and seamless health system by reducing complexity and increasing flexibility.”

Counties currently receive a portion of state sales tax revenue and vehicle license fees to fund specialty mental health care, but under the agreement in Sacramento and Solano, the state has been paying Kaiser Permanente from its general fund to serve a portion of the insurer’s overall Medi-Cal enrollees’ mental health needs.

Under the shift, California would stop distributing general-fund money to the counties. Instead, counties would receive a greater share of existing sales tax and vehicle license fee revenues set aside by a 2011 arrangement. But Kaiser Permanente’s specialty mental health patients, the counties argue, were not under their purview at the time that agreement was reached, underscoring their legal argument that the state should cover the costs of their care.

The state is offering an additional $11.6 million a year to Sacramento and $7.7 million a year to Solano, which would draw down additional federal funding. That money would be siphoned from revenue other counties rely on for behavioral health treatment.

“The insult to injury is this takes money from other counties,” said Michelle Doty Cabrera, executive director of the County Behavioral Health Directors Association, “and across California we’re seeing a greater demand for services, especially after the pandemic.”

Sacramento County wants $36 million more each year to cover a 16% increase in patients, or 4,836 people. Solano County seeks nearly $17 million more each year for increasing its load by 50%, or 2,091 patients.

Behavioral health officials say counties are also struggling to recruit and retain mental health professionals willing to serve Medi-Cal patients.

“Our system is already bursting at the seams,” said Le Ondra Clark Harvey, CEO of the California Council of Community Behavioral Health Agencies, which represents local mental health providers.

State officials believe that both counties have an adequate number of mental health providers, with the small exception of Sacramento County’s need for two to three additional psychiatrists to serve kids.

Kaiser Permanente told KHN that it did not ask to move patients out of its network of care and that it told the state it wanted to continue serving them. Yet it ultimately agreed to transfer care to the counties.

“While we had expressed our preference to continue to provide specialty care to this vulnerable population,” said spokesperson Gerri Ginsburg, “we respect the state’s long-term objectives.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is 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.

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Estrés pandémico, pandillas y miedo impulsaron un aumento de tiroteos adolescentes

Kaiser Health News - Tue, 03/14/2023 - 1:14pm

Diego nunca imaginó que portaría un arma.

No lo pensó cuando niño, o durante un tiroteo fuera de su casa en el área de Chicago. Tampoco a los 12 años, cuando uno de sus amigos fue baleado.

La mente de Diego cambió a los 14, cuando él y sus amigos estaban listos para ir a la vigilia de Nuestra Señora de Guadalupe. Esa noche, en lugar de cánticos religiosos, escuchó disparos y gritos. Un pandillero le había disparado a dos personas, una de ellas un amigo suyo, quien recibió nueve balazos.

“Mi amigo se estaba desangrando”, dijo Diego, quien le pidió a KHN no utilizar su apellido para proteger su seguridad y privacidad. Mientras su amigo yacía en el suelo, “se estaba ahogando en su propia sangre”.

El ataque dejó al amigo de Diego paralizado de la cintura para abajo. Y a Diego, uno de un número creciente de adolescentes que son testigos de la violencia armada, traumatizado y con miedo de salir a la calle sin un arma.

Investigaciones muestran que los adolescentes expuestos a la violencia armada tienen el doble de probabilidades que otros de cometer un delito violento grave dentro de los dos años luego del trauma, lo que perpetúa un ciclo difícil de romper.

Diego pidió ayuda a sus amigos para tener una pistola y, en un país sobrecargado con armas de fuego, no tuvieron problemas para conseguirle una, que le dieron gratis.

“Me sentí más seguro con el arma”, dijo Diego, que ahora tiene 21 años. “Esperaba no usarla”.

Durante dos años, Diego mantuvo el arma solo como elemento de disuasión. Cuando finalmente apretó el gatillo, cambió su vida para siempre.

Tendencias inquietantes

Los medios de comunicación se centran en gran medida en los tiroteos masivos y el estado mental de las personas que los cometen.

Pero hay una epidemia mucho mayor de violencia armada —particularmente entre los jóvenes negros no hispanos, hispanos (que pueden ser de cualquier raza) y nativos americanos— que atrapa a muchos que ni siquiera tienen edad suficiente para obtener una licencia de conducir.

Estudios muestran que la exposición crónica al trauma puede cambiar la forma en que se desarrolla el cerebro de un niño. El trauma también puede desempeñar un papel central en la explicación de por qué algunos jóvenes buscan protección en las armas y terminan usándolas contra sus compañeros.

La cantidad de niños menores de 18 años que mataron a alguien con un arma de fuego aumentó de 836 en 2019 a 1,150 en 2020.

En la ciudad de Nueva York, la cantidad de jóvenes que mataron a alguien con un arma aumentó más del doble, pasando de 48 delincuentes juveniles en 2019 a 124 en 2022, según datos del departamento de policía de la ciudad.

La violencia armada juvenil aumentó más modestamente en otras ciudades; en muchos lugares, la cantidad de homicidios de adolescentes con armas de fuego subió en 2020, pero desde entonces se ha acercado a los niveles previos a la pandemia.

Investigadores que analizan las estadísticas del crimen enfatizan que los adolescentes no están impulsando el aumento general de la violencia armada, que ha aumentado en todas las edades. En 2020, el 7,5% de los arrestos por homicidio involucraron a menores de 18 años, una proporción ligeramente menor que en años anteriores.

A líderes locales les cuesta encontrar la mejor manera de responder a los tiroteos adolescentes.

Un puñado de comunidades, incluidas Pittsburgh; el condado de Fulton, en Georgia; y el condado de Prince George, en Maryland, han debatido o implementado toques de queda juveniles para frenar la violencia adolescente. Lo que no está en discusión: más personas de 1 a 19 años mueren por violencia armada que por cualquier otra causa.

Una vida de límites

El número devastador de la violencia armada se revela a diario en las salas de emergencia.

En el centro de trauma de UChicago Medicine, la cantidad de heridas de bala en menores de 16 años se ha duplicado en los últimos seis años, dijo el doctor Selwyn Rogers, director fundador del centro. La víctima más joven tenía 2 años.

“Escuchas a la madre gemir o al hermano decir: ‘No es cierto’”, dijo Rogers, quien trabaja con jóvenes locales como vicepresidente ejecutivo del hospital para salud comunitaria. “Tienes que estar presente en ese momento, pero luego salir por la puerta y lidiar con todo de nuevo”.

En los últimos años, el sistema judicial ha luchado por equilibrar la necesidad de seguridad pública con la compasión por los menores, según investigaciones que muestran que el cerebro de una persona joven no madura por completo hasta los 25 años.

La mayoría de los delincuentes jóvenes “superan la edad” del comportamiento delictivo o violento casi al mismo tiempo, a medida que desarrollan más autocontrol y habilidades de pensamiento de largo alcance.

Sin embargo, los adolescentes acusados de tiroteos a menudo son enjuiciados​​ como adultos, lo que significa que enfrentan castigos más severos, dijo Josh Rovner, director de justicia juvenil en Sentencing Project, que aboga por la reforma del sistema judicial.

En 2019, aproximadamente 53,000 menores fueron acusados como adultos, lo que puede tener graves repercusiones para la salud. Estos adolescentes tienen más probabilidades de ser victimizados mientras están presos, dijo Rovner, y de ser arrestados nuevamente después de quedar libres.

Los jóvenes pueden pasar gran parte de sus vidas en un “aislamiento” impuesto por la pobreza, sin aventurarse más allá de sus vecindarios, aprendiendo poco sobre las oportunidades que existen en el resto del mundo, dijo Rogers. Millones de niños estadounidenses, en particular niños negros no hispanos, latinos y nativos americanos, viven en entornos plagados de pobreza, violencia y consumo de drogas.

La pandemia de covid-19 amplificó todos esos problemas, desde el desempleo hasta la inseguridad alimentaria y de vivienda.

Aunque nadie puede decir con certeza qué provocó el aumento de tiroteos en 2020, la investigación ha relacionado durante mucho tiempo la desesperanza y la falta de confianza en la policía, que aumentó después del asesinato de George Floyd ese año, con un mayor riesgo de violencia comunitaria.

Las ventas de armas se dispararon un 64% entre 2019 y 2020, mientras que se cancelaron muchos programas de prevención de la violencia.

Una de las pérdidas más graves que enfrentaron los niños durante la pandemia fue el cierre de las escuelas durante un año o más, justamente las instituciones que proporcionan tal vez la única fuerza estabilizadora en sus jóvenes vidas.

“La pandemia encendió el fuego debajo de la olla”, dijo Elise White, subdirectora de investigación Center for Justice Innovation, un entidad sin fines de lucro que trabaja con comunidades y sistemas de justicia. “Mirando hacia atrás, es fácil restar importancia ahora a lo incierto que se sintió ese momento [de la pandemia]. Cuanto más insegura se sienta la gente, cuanto más sientan que no hay seguridad a su alrededor, más probable es que porten armas”.

Por supuesto, la mayoría de los niños que experimentan dificultades nunca infringen la ley. Múltiples estudios han encontrado que la mayor parte de la violencia armada es perpetrada por un número relativamente pequeño de personas.

Incluso la presencia de un adulto solidario puede proteger a los niños de involucrarse en la delincuencia, explicó el doctor Abdullah Pratt, médico de emergencias de UChicago Medicine que perdió a su hermano por la violencia con armas de fuego.

Pratt también perdió a cuatro amigos por la violencia con armas durante la pandemia. Los cuatro murieron en su sala de emergencias; uno era el hijo de una enfermera del hospital.

Aunque Pratt creció en una parte de Chicago donde las pandillas callejeras eran comunes, se benefició del apoyo de padres amorosos y fuertes modelos a seguir, como maestros y entrenadores de fútbol americano. A Pratt también lo protegió su hermano mayor, quien lo cuidaba y se aseguraba de que las pandillas dejaran en paz al futuro médico.

“Todo lo que he podido lograr”, dijo Pratt, “es porque alguien me ayudó”.

Crecer en una “zona de guerra”

Diego no tenía adultos en casa que lo ayudaran a sentirse seguro.

A menudo, sus propios padres eran violentos. Una vez, en un ataque de ira por la borrachera, su padre lo agarró por la pierna y lo zarandeó por la habitación, contó Diego; y su madre una vez le arrojó una tostadora a su padre.

A los 12 años, los esfuerzos de Diego para ayudar a la familia a pagar las facturas atrasadas —vendiendo marihuana, y robando autos y apartamentos— llevaron a su padre a echarlo de la casa.

A los 13 años, Diego se unió a una pandilla del barrio. Los pandilleros, que contaron historias similares sobre huir del hogar para escapar del abuso, le dieron comida y un lugar para quedarse. “Éramos como una familia”, dijo Diego. Cuando tenían hambre y no había comida en casa, “íbamos juntos a una gasolinera a robar algo de desayuno”.

Pero Diego, que era más pequeño que la mayoría de los demás, vivía con miedo. A los 16, pesaba solo 100 libras. Los chicos más grandes lo intimidaban y lo golpeaban. Y su exitosa actividad, vender mercadería robada en la calle por dinero en efectivo, llamó la atención de pandilleros rivales, quienes amenazaron con robarle.

Los niños que experimentan violencia crónica pueden desarrollar una “mentalidad de zona de guerra”, volviéndose hipervigilantes ante las amenazas, a veces sintiendo peligro donde no existe, dijo James Garbarino, profesor emérito de psicología en la Universidad de Cornell y la Universidad de Loyola-Chicago.

Los niños que viven con miedo constante tienen más probabilidades de buscar protección en las armas de fuego o en las pandillas. Se puede activar para que tomen medidas preventivas, como disparar un arma sin pensar, contra lo que perciben como una amenaza.

“Sus cuerpos están constantemente listos para pelear”, dijo Gianna Tran, subdirectora ejecutiva del East Bay Asian Youth Center en Oakland, California, que trabaja con jóvenes en riesgo.

A diferencia de los perpetradores de tiroteos masivos, que compran armas y municiones porque tienen la intención de asesinar, la mayor parte de la violencia adolescente no es premeditada, dijo Garbarino.

En las encuestas, la mayoría de los jóvenes que portan armas, incluidos los pandilleros, dicen que lo hacen por miedo o para disuadir ataques, en lugar de perpetrarlos. Pero el miedo a la violencia comunitaria, tanto de los rivales como de la policía, puede avivar una carrera armamentista urbana, en la que los menores sienten que solo los tontos no portan armas.

“Fundamentalmente, la violencia es una enfermedad contagiosa”, dijo el doctor Gary Slutkin, fundador de Cure Violence Global, que trabaja para prevenir la violencia comunitaria.

Aunque un pequeño número de adolescentes se vuelven duros y despiadados, Pratt dijo que ve muchos más tiroteos causados ​​por la “pobre resolución de un conflicto” y la impulsividad de los adolescentes en lugar de un deseo de matar.

De hecho, las armas de fuego y un cerebro adolescente inmaduro son una mezcla peligrosa, enfatizó Garbarino. El alcohol y las drogas pueden aumentar el riesgo. Cuando se enfrentan a una situación potencialmente de vida o muerte, pueden actuar sin pensar.

Cuando Diego tenía 16 años, estaba acompañando a una niña a la escuela y se les acercaron tres jóvenes, incluido un pandillero, quien, usando un lenguaje obsceno y amenazante, le preguntó a Diego si también estaba en una pandilla. Diego dijo que trató de pasar de largo, y uno de ellos parecía tener un arma.

“No sabía cómo disparar un arma”, dijo Diego. “Solo quería que huyeran”.

En las noticias sobre el tiroteo, testigos dijeron que escucharon cinco disparos. “Lo único que recuerdo es el sonido de los disparos”, dijo Diego. “Todo lo demás fue en cámara lenta”.

Diego había disparado a dos de los muchachos en las piernas. La niña corrió por un lado y él por otro. La policía lo arrestó en su casa unas horas después. Fue juzgado como adulto, condenado por dos cargos de intento de homicidio y sentenciado a 12 años.

Una segunda oportunidad

En las últimas dos décadas, el sistema judicial ha realizado cambios importantes en la forma en que trata a los niños.

Los arrestos de jóvenes por delitos violentos bajaron dramáticamente un 67% entre 2006 y 2020, y 40 estados han hecho que sea más difícil acusar a menores como adultos.

Los estados también están adoptando alternativas a la cárcel, como hogares grupales que permiten a los adolescentes permanecer en sus comunidades, al tiempo que brindan tratamiento para ayudarlos a cambiar su conducta.

Debido a que Diego tenía 17 años cuando fue sentenciado, fue enviado a un centro de menores, donde recibió terapia por primera vez.

Diego terminó la escuela secundaria mientras estaba tras las rejas, y obtuvo un título de un colegio comunitario. Con otros jóvenes reclusos fue de excursión a teatros y al acuario, lugares en los que nunca había estado. La directora del centro de detención le pidió que la acompañara a eventos sobre la reforma de la justicia juvenil, donde lo invitaron a contar su historia.

Para Diego, esas fueron experiencias reveladoras: se dio cuenta de que había visto muy poco de Chicago, a pesar de que había pasado su vida allí.

“Mientras estás creciendo, lo único que ves es a tu comunidad”, dijo Diego, quien fue liberado después de cuatro años, cuando el gobernador conmutó su sentencia. “Asumes que el mundo entero es así”.

La editora de datos de KHN Holly K. Hacker y la investigadora Megan Kalata contribuyeron con este informe.

KHN (Kaiser Health News) is 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.

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