Kaiser Health News
Psychoactive Drugs Are Having a Moment. The FDA Will Soon Weigh In.
Dawn Megli
Wed, 29 May 2024 09:00:00 +0000
Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives.
Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured layers of trauma that eventually forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years nothing helped, and she began to wonder if she was “unfixable.”
Then she answered an ad for a clinical trial for MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate, and she is convinced the drug could help a lot of people. But even as regulators weigh approval of the first MDMA-based treatment, she’s worried that it won’t reach those who need it most.
“The main thing that I’m always concerned about is just accessibility,” the 43-year-old nonprofit project manager said. “I don’t want to see this become just another expensive add-on therapy for people who can afford it when people are dying every day by their own hand because of PTSD.”
MDMA is part of a new wave of psychoactive drugs that show great potential for treating conditions such as severe depression and PTSD. Investors are piling into the nascent field, and a host of medications based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American plant mixture ayahuasca, and the African plant ibogaine are now under development, and in some cases vying for approval by the Food and Drug Administration.
Proponents hope the efforts could yield the first major new therapies for mental illness since the introduction of modern antidepressants in the 1980s. But not all researchers are convinced that their benefits have been validated, or properly weighed against the risks. And they can be difficult to assess using traditional clinical trials.
The first MDMA-assisted assisted therapy appeared to be on track for FDA approval this August, but a recent report from an independent review committee challenged the integrity of the trial data from the drug’s maker, Lykos Therapeutics, a startup founded by a psychedelic research and advocacy group. The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend the drug’s approval.
Proponents of the new therapies also worry that the FDA will impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for extended periods, that will render them far too expensive for most people.
Tipton’s MDMA-assisted therapy included three eight-hour medication sessions overseen by two therapists, each followed by an overnight stay at the facility and an integration session the following day.
“It does seem that some of these molecules can be administered safely,” said David Olson, director of the University of California-Davis Institute for Psychedelics and Neurotherapeutics. “I think the question is can they be administered safely at the scale needed to really make major improvements in mental health care.”
Breakthrough Therapies?
Psychedelics and other psychoactive substances, among the medicines with the oldest recorded use, have long been recognized for their potential therapeutic benefits. Modern research on them started in the mid-20th century, but clinical trial results didn’t live up to the claims of advocates, and they eventually got a bad name both from their use as party drugs and from rogue CIA experiments that involved dosing unsuspecting individuals.
The 1970 Controlled Substances Act made most psychoactive drugs illegal before any treatments were brought to market, and MDMA was classified as a Schedule 1 substance in 1985, which effectively ended any research. It wasn’t until 2000 that scientists at Johns Hopkins University were granted regulatory approval to study psilocybin anew.
Ketamine was in a different category, having been approved as an anesthetic in 1970. In the early 2000s, researchers discovered its antidepressant effects, and a ketamine-based therapy, Spravato, received FDA approval in 2019. Doctors can also prescribe generic ketamine off-label, and hundreds of clinics have sprung up across the nation. A clinical trial is underway to evaluate ketamine’s effectiveness in treating suicidal depression when used with other psychiatric medications.
Ketamine’s apparent effectiveness sparked renewed interest in the therapeutic potential of other psychoactive substances.
They fall into distinct categories: MDMA is an entactogen, also known as an empathogen, which induces a sense of connectedness and emotional communion, while LSD, psylocibin, and ibogaine are psychedelics, which create altered perceptual states. Ketamine is a dissociative anesthetic, though it can produce hallucinations at the right dose.
Despite the drugs’ differences, Olson said they all create neuroplasticity and allow the brain to heal damaged neural circuits, which imaging shows can be shriveled up in patients with addiction, depression, and PTSD.
“All of these brain conditions are really disorders of neural circuits,” Olson said. “We’re basically looking for medicines that can regrow these neurons.”
Psychedelics are particularly good at doing this, he said, and hold promise for treating diseases including Alzheimer’s.
A number of psychoactive drugs have now received the FDA’s “breakthrough therapy” designation, which expedites development and review of drugs with the potential to treat serious conditions.
But standard clinical trials, in which one group of patients is given the drug and a control group is given a placebo, have proven problematic, for the simple reason that people have no trouble determining whether they’ve gotten the real thing.
The final clinical trial for Lykos’ MDMA treatment showed that 71% of participants no longer met the criteria for PTSD after 18 weeks of taking the drug versus 48% in the control group.
A March report by the Institute for Clinical and Economic Review, an independent research group, questioned the company’s clinical trial results and challenged the objectivity of MDMA advocates who participated in the study as both patients and therapists. The institute also questioned the drug’s cost-effectiveness, which insurers factor into coverage decisions.
Lykos, a public benefit company, was formed in 2014 as an offshoot of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that has invested more than $150 million into psychedelic research and advocacy.
The company said its researchers developed their studies in partnership with the FDA and used independent raters to ensure the reliability and validity of the results.
“We stand behind the design and results of our clinical trials,” a Lykos spokesperson said in an email.
There are other hazards too. Psychoactive substances can put patients in vulnerable states, making them potential victims for financial exploitation or other types of abuse. In Lykos’ second clinical trial, two therapists were found to have spooned, cuddled, blindfolded, and pinned down a female patient who was in distress.
The substances can also cause shallow breathing, heart issues, and hyperthermia.
To mitigate risks, the FDA can put restrictions on how drugs are administered.
“These are incredibly potent molecules and having them available in vending machines is probably a bad idea,” said Hayim Raclaw of Negev Capital, a venture capital fund focused on psychedelic drug development.
But if the protocols are too stringent, access is likely to be limited.
Rachel del Dosso, a trauma therapist in the greater Los Angeles area who offers ketamine-assisted therapy, said she’s been following the research on drugs like MDMA and psilocybin and is excited for their therapeutic potential but has reservations about the practicalities of treatment.
“As a therapist in clinical practice, I’ve been thinking through how could I make that accessible,” she said. “Because it would cost a lot for [patients] to have me with them for the whole thing.”
Del Dosso said a group therapy model, which is sometimes used in ketamine therapy, could help scale the adoption of other psychoactive treatments, too.
Artificial Intelligence and Analogs
Researchers expect plenty of new discoveries in the field. One of the companies Negev has invested in, Mindstate Design Labs, uses artificial intelligence to analyze “trip reports,” or self-reported drug experiences, to identify potentially therapeutic molecules. Mindstate has asked the FDA to green-light a clinical trial of the first molecule identified through this method, 5-MeO-MiPT, also known as moxy.
AlphaFold, an AI program developed by Google’s DeepMind, has identified thousands of potential psychedelic molecules.
There’s also a lot of work going into so-called analog compounds, which have the therapeutic effects of hallucinogens but without the hallucinations. The maker of a psilocybin analog announced in March that the FDA had granted it breakthrough therapy status.
“If you can harness the neuroplasticity-promoting properties of LSD while also creating an antipsychotic version of it, then that can be pretty powerful,” Olson said.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
——————————
By: Dawn Megli
Title: Psychoactive Drugs Are Having a Moment. The FDA Will Soon Weigh In.
Sourced From: kffhealthnews.org/news/article/psychoactive-drugs-popularity-fda-regulation-studies-mdma/
Published Date: Wed, 29 May 2024 09:00:00 +0000
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Kaiser Health News
States Brace for Reversal of Obamacare Coverage Gains Under Trump’s Budget Bill
Shorter enrollment periods. More paperwork. Higher premiums. The sweeping tax and spending bill pushed by President Donald Trump includes provisions that would not only reshape people’s experience with the Affordable Care Act but, according to some policy analysts, also sharply undermine the gains in health insurance coverage associated with it.
The moves affect consumers and have particular resonance for the 19 states (plus Washington, D.C.) that run their own ACA exchanges.
Many of those states fear that the additional red tape — especially requirements that would end automatic reenrollment — would have an outsize impact on their policyholders. That’s because a greater percentage of people in those states use those rollovers versus shopping around each year, which is more commonly done by people in states that use the federal healthcare.gov marketplace.
“The federal marketplace always had a message of, ‘Come back in and shop,’ while the state-based markets, on average, have a message of, ‘Hey, here’s what you’re going to have next year, here’s what it will cost; if you like it, you don’t have to do anything,’” said Ellen Montz, who oversaw the federal ACA marketplace under the Biden administration as deputy administrator and director at the Center for Consumer Information and Insurance Oversight. She is now a managing director with the Manatt Health consulting group.
Millions — perhaps up to half of enrollees in some states — may lose or drop coverage as a result of that and other changes in the legislation combined with a new rule from the Trump administration and the likely expiration at year’s end of enhanced premium subsidies put in place during the covid-19 pandemic. Without an extension of those subsidies, which have been an important driver of Obamacare enrollment in recent years, premiums are expected to rise 75% on average next year. That’s starting to happen already, based on some early state rate requests for next year, which are hitting double digits.
“We estimate a minimum 30% enrollment loss, and, in the worst-case scenario, a 50% loss,” said Devon Trolley, executive director of Pennie, the ACA marketplace in Pennsylvania, which had 496,661 enrollees this year, a record.
Drops of that magnitude nationally, coupled with the expected loss of Medicaid coverage for millions more people under the legislation Trump calls the “One Big Beautiful Bill,” could undo inroads made in the nation’s uninsured rate, which dropped by about half from the time most of the ACA’s provisions went into effect in 2014, when it hovered around 14% to 15% of the population, to just over 8%, according to the most recent data.
Premiums would rise along with the uninsured rate, because older or sicker policyholders are more likely to try to jump enrollment hurdles, while those who rarely use coverage — and are thus less expensive — would not.
After a dramatic all-night session, House Republicans passed the bill, meeting the president’s July 4 deadline. Trump is expected to sign the measure on Independence Day. It would increase the federal deficit by trillions of dollars and cut spending on a variety of programs, including Medicaid and nutrition assistance, to partly offset the cost of extending tax cuts put in place during the first Trump administration.
The administration and its supporters say the GOP-backed changes to the ACA are needed to combat fraud. Democrats and ACA supporters see this effort as the latest in a long history of Republican efforts to weaken or repeal Obamacare. Among other things, the legislation would end several changes put in place by the Biden administration that were credited with making it easier to sign up, such as lengthening the annual open enrollment period and launching a special program for very low-income people that essentially allows them to sign up year-round.
In addition, automatic reenrollment, used by more than 10 million people for 2025 ACA coverage, would end in the 2028 sign-up season. Instead, consumers would have to update their information, starting in August each year, before the close of open enrollment, which would end Dec. 15, a month earlier than currently.
That’s a key change to combat rising enrollment fraud, said Brian Blase, president of the conservative Paragon Health Institute, because it gets at what he calls the Biden era’s “lax verification requirements.”
He blames automatic reenrollment, coupled with the availability of zero-premium plans for people with lower incomes that qualify them for large subsidies, for a sharp uptick in complaints from insurers, consumers, and brokers about fraudulent enrollments in 2023 and 2024. Those complaints centered on consumers’ being enrolled in an ACA plan, or switched from one to another, without authorization, often by commission-seeking brokers.
In testimony to Congress on June 25, Blase wrote that “this simple step will close a massive loophole and significantly reduce improper enrollment and spending.”
States that run their own marketplaces, however, saw few, if any, such problems, which were confined mainly to the 31 states using the federal healthcare.gov.
The state-run marketplaces credit their additional security measures and tighter control over broker access than healthcare.gov for the relative lack of problems.
“If you look at California and the other states that have expanded their Medicaid programs, you don’t see that kind of fraud problem,” said Jessica Altman, executive director of Covered California, the state’s Obamacare marketplace. “I don’t have a single case of a consumer calling Covered California saying, ‘I was enrolled without consent.’”
Such rollovers are common with other forms of health insurance, such as job-based coverage.
“By requiring everyone to come back in and provide additional information, and the fact that they can’t get a tax credit until they take this step, it is essentially making marketplace coverage the most difficult coverage to enroll in,” said Trolley at Pennie, 65% of whose policyholders were automatically reenrolled this year, according to KFF data. KFF is a health information nonprofit that includes KFF Health News.
Federal data shows about 22% of federal sign-ups in 2024 were automatic-reenrollments, versus 58% in state-based plans. Besides Pennsylvania, the states that saw such sign-ups for more than 60% of enrollees include California, New York, Georgia, New Jersey, and Virginia, according to KFF.
States do check income and other eligibility information for all enrollees — including those being automatically renewed, those signing up for the first time, and those enrolling outside the normal open enrollment period because they’ve experienced a loss of coverage or other life event or meet the rules for the low-income enrollment period.
“We have access to many data sources on the back end that we ping, to make sure nothing has changed. Most people sail through and are able to stay covered without taking any proactive step,” Altman said.
If flagged for mismatched data, applicants are asked for additional information. Under current law, “we have 90 days for them to have a tax credit while they submit paperwork,” Altman said.
That would change under the tax and spending plan before Congress, ending presumptive eligibility while a person submits the information.
A white paper written for Capital Policy Analytics, a Washington-based consultancy that specializes in economic analysis, concluded there appears to be little upside to the changes.
While “tighter verification can curb improper enrollments,” the additional paperwork, along with the expiration of higher premiums from the enhanced tax subsidies, “would push four to six million eligible people out of Marketplace plans, trading limited fraud savings for a surge in uninsurance,” wrote free market economists Ike Brannon and Anthony LoSasso.
“Insurers would be left with a smaller, sicker risk pool and heightened pricing uncertainty, making further premium increases and selective market exits [by insurers] likely,” they wrote.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post States Brace for Reversal of Obamacare Coverage Gains Under Trump’s Budget Bill appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content presents a critique of Republican-led changes to the Affordable Care Act, emphasizing potential negative impacts such as increased premiums, reduced enrollment, and the erosion of coverage gains made under the ACA. It highlights the perspective of policy analysts and state officials who express concern over these measures, while also presenting conservative viewpoints, particularly those focusing on fraud reduction. Overall, the tone and framing lean toward protecting the ACA and its expansions, which traditionally aligns with Center-Left media analysis.
Kaiser Health News
Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers
In a top-rated nursing home in Alexandria, Virginia, the Rev. Donald Goodness is cared for by nurses and aides from various parts of Africa. One of them, Jackline Conteh, a naturalized citizen and nurse assistant from Sierra Leone, bathes and helps dress him most days and vigilantly intercepts any meal headed his way that contains gluten, as Goodness has celiac disease.
“We are full of people who come from other countries,” Goodness, 92, said about Goodwin House Alexandria’s staff. Without them, the retired Episcopal priest said, “I would be, and my building would be, desolate.”
The long-term health care industry is facing a double whammy from President Donald Trump’s crackdown on immigrants and the GOP’s proposals to reduce Medicaid spending. The industry is highly dependent on foreign workers: More than 800,000 immigrants and naturalized citizens comprise 28% of direct care employees at home care agencies, nursing homes, assisted living facilities, and other long-term care companies.
But in January, the Trump administration rescinded former President Joe Biden’s 2021 policy that protected health care facilities from Immigration and Customs Enforcement raids. The administration’s broad immigration crackdown threatens to drastically reduce the number of current and future workers for the industry. “People may be here on a green card, and they are afraid ICE is going to show up,” said Katie Smith Sloan, president of LeadingAge, an association of nonprofits that care for older adults.
Existing staffing shortages and quality-of-care problems would be compounded by other policies pushed by Trump and the Republican-led Congress, according to nursing home officials, resident advocates, and academic experts. Federal spending cuts under negotiation may strip nursing homes of some of their largest revenue sources by limiting ways states leverage Medicaid money and making it harder for new nursing home residents to retroactively qualify for Medicaid. Care for 6 in 10 residents is paid for by Medicaid, the state-federal health program for poor or disabled Americans.
“We are facing the collision of two policies here that could further erode staffing in nursing homes and present health outcome challenges,” said Eric Roberts, an associate professor of internal medicine at the University of Pennsylvania.
The industry hasn’t recovered from covid-19, which killed more than 200,000 long-term care facility residents and workers and led to massive staff attrition and turnover. Nursing homes have struggled to replace licensed nurses, who can find better-paying jobs at hospitals and doctors’ offices, as well as nursing assistants, who can earn more working at big-box stores or fast-food joints. Quality issues that preceded the pandemic have expanded: The percentage of nursing homes that federal health inspectors cited for putting residents in jeopardy of immediate harm or death has risen alarmingly from 17% in 2015 to 28% in 2024.
In addition to seeking to reduce Medicaid spending, congressional Republicans have proposed shelving the biggest nursing home reform in decades: a Biden-era rule mandating minimum staffing levels that would require most of the nation’s nearly 15,000 nursing homes to hire more workers.
The long-term care industry expects demand for direct care workers to burgeon with an influx of aging baby boomers needing professional care. The Census Bureau has projected the number of people 65 and older would grow from 63 million this year to 82 million in 2050.
In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.” In a separate email, Tricia McLaughlin, a Department of Homeland Security spokesperson, said foreigners wanting to work as caregivers “need to do that by coming here the legal way” but did not address the effect on the long-term care workforce of deportations of classes of authorized immigrants.
Goodwin Living, a faith-based nonprofit, runs three retirement communities in northern Virginia for people who live independently, need a little assistance each day, have memory issues, or require the availability of around-the-clock nurses. It also operates a retirement community in Washington, D.C. Medicare rates Goodwin House Alexandria as one of the best-staffed nursing homes in the country. Forty percent of the organization’s 1,450 employees are foreign-born and are either seeking citizenship or are already naturalized, according to Lindsay Hutter, a Goodwin spokesperson.
“As an employer, we see they stay on with us, they have longer tenure, they are more committed to the organization,” said Rob Liebreich, Goodwin’s president and CEO.
Jackline Conteh spent much of her youth shuttling between Sierra Leone, Liberia, and Ghana to avoid wars and tribal conflicts. Her mother was killed by a stray bullet in her home country of Liberia, Conteh said. “She was sitting outside,” Conteh, 56, recalled in an interview.
Conteh was working as a nurse in a hospital in Sierra Leone in 2009 when she learned of a lottery for visas to come to the United States. She won, though she couldn’t afford to bring her husband and two children along at the time. After she got a nursing assistant certification, Goodwin hired her in 2012.
Conteh said taking care of elders is embedded in the culture of African families. When she was 9, she helped feed and dress her grandmother, a job that rotated among her and her sisters. She washed her father when he was dying of prostate cancer. Her husband joined her in the United States in 2017; she cares for him because he has heart failure.
“Nearly every one of us from Africa, we know how to care for older adults,” she said.
Her daughter is now in the United States, while her son is still in Africa. Conteh said she sends money to him, her mother-in-law, and one of her sisters.
In the nursing home where Goodness and 89 other residents live, Conteh helps with daily tasks like dressing and eating, checks residents’ skin for signs of swelling or sores, and tries to help them avoid falling or getting disoriented. Of 102 employees in the building, broken up into eight residential wings called “small houses” and a wing for memory care, at least 72 were born abroad, Hutter said.
Donald Goodness grew up in Rochester, New York, and spent 25 years as rector of The Church of the Ascension in New York City, retiring in 1997. He and his late wife moved to Alexandria to be closer to their daughter, and in 2011 they moved into independent living at the Goodwin House. In 2023 he moved into one of the skilled nursing small houses, where Conteh started caring for him.
“I have a bad leg and I can’t stand on it very much, or I’d fall over,” he said. “She’s in there at 7:30 in the morning, and she helps me bathe.” Goodness said Conteh is exacting about cleanliness and will tell the housekeepers if his room is not kept properly.
Conteh said Goodness was withdrawn when he first arrived. “He don’t want to come out, he want to eat in his room,” she said. “He don’t want to be with the other people in the dining room, so I start making friends with him.”
She showed him a photo of Sierra Leone on her phone and told him of the weather there. He told her about his work at the church and how his wife did laundry for the choir. The breakthrough, she said, came one day when he agreed to lunch with her in the dining room. Long out of his shell, Goodness now sits on the community’s resident council and enjoys distributing the mail to other residents on his floor.
“The people that work in my building become so important to us,” Goodness said.
While Trump’s 2024 election campaign focused on foreigners here without authorization, his administration has broadened to target those legally here, including refugees who fled countries beset by wars or natural disasters. This month, the Department of Homeland Security revoked the work permits for migrants and refugees from Cuba, Haiti, Nicaragua, and Venezuela who arrived under a Biden-era program.
“I’ve just spent my morning firing good, honest people because the federal government told us that we had to,” Rachel Blumberg, president of the Toby & Leon Cooperman Sinai Residences of Boca Raton, a Florida retirement community, said in a video posted on LinkedIn. “I am so sick of people saying that we are deporting people because they are criminals. Let me tell you, they are not all criminals.”
At Goodwin House, Conteh is fearful for her fellow immigrants. Foreign workers at Goodwin rarely talk about their backgrounds. “They’re scared,” she said. “Nobody trusts anybody.” Her neighbors in her apartment complex fled the U.S. in December and returned to Sierra Leone after Trump won the election, leaving their children with relatives.
“If all these people leave the United States, they go back to Africa or to their various countries, what will become of our residents?” Conteh asked. “What will become of our old people that we’re taking care of?”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content primarily highlights concerns about the impact of restrictive immigration policies and Medicaid spending cuts proposed by the Trump administration and Republican lawmakers on the long-term care industry. It emphasizes the importance of immigrant workers in healthcare, the challenges that staffing shortages pose to patient care, and the potential negative effects of GOP policy proposals. The tone is critical of these policies while sympathetic toward immigrant workers and advocates for maintaining or increasing government support for healthcare funding. The framing aligns with a center-left perspective, focusing on social welfare, immigrant rights, and concern about the consequences of conservative economic and immigration policies without descending into partisan rhetoric.
Kaiser Health News
California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch
California lawmakers are poised to delay the state’s much-ballyhooed new law mandating in vitro fertilization insurance coverage for millions, set to take effect July 1. Gov. Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo.
The law, SB 729, requires state-regulated health plans offered by large employers to cover infertility diagnosis and treatment, including IVF. Nine million people will qualify for coverage under the law. Advocates have praised the law as “a major win for Californians,” especially in making same-sex couples and aspiring single parents eligible, though cost concerns limited the mandate’s breadth.
People who had been planning fertility care based on the original timeline are now “left in a holding pattern facing more uncertainty, financial strain, and emotional distress,” Alise Powell, a director at Resolve: The National Infertility Association, said in a statement.
During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000, out of reach for many. The California law requires insurers to cover up to three egg retrievals and an unlimited number of embryo transfers.
Not everyone’s coverage would be affected by the delay. Even if the law took effect July 1, it wouldn’t require IVF coverage to start until the month an employer’s contract renews with its insurer. Rachel Arrezola, a spokesperson for the California Department of Managed Health Care, said most of the employers subject to the law renew their contracts in January, so their employees would not be affected by a delay.
She declined to provide data on the percentage of eligible contracts that renew in July or later, which would mean those enrollees wouldn’t get IVF coverage until at least a full year from now, in July 2026 or later.
The proposed new implementation date comes amid heightened national attention on fertility coverage. California is now one of 15 states with an IVF mandate, and in February, President Donald Trump signed an executive order seeking policy recommendations to expand IVF access.
It’s the second time Newsom has asked lawmakers to delay the law. When the Democratic governor signed the bill in September, he asked the legislature to consider delaying implementation by six months. The reason, Newsom said then, was to allow time to reconcile differences between the bill and a broader effort by state regulators to include IVF and other fertility services as an essential health benefit, which would require the marketplace and other individual and small-group plans to provide the coverage.
Newsom spokesperson Elana Ross said the state needs more time to provide guidance to insurers on specific services not addressed in the law to ensure adequate and uniform coverage. Arrezola said embryo storage and donor eggs and sperm were examples of services requiring more guidance.
State Sen. Caroline Menjivar, a Democrat who authored the original IVF mandate, acknowledged a delay could frustrate people yearning to expand their families, but requested patience “a little longer so we can roll this out right.”
Sean Tipton, a lobbyist for the American Society for Reproductive Medicine, contended that the few remaining questions on the mandate did not warrant a long delay.
Lawmakers appear poised to advance the delay to a vote by both houses of the legislature, likely before the end of June. If a delay is approved and signed by the governor, the law would immediately be paused. If this does not happen before July 1, Arrezola said, the Department of Managed Health Care would enforce the mandate as it exists. All plans were required to submit compliance filings to the agency by March. Arrezola was unable to explain what would happen to IVF patients whose coverage had already begun if the delay passes after July 1.
The California Association of Health Plans, which opposed the mandate, declined to comment on where implementation efforts stand, although the group agrees that insurers need more guidance, spokesperson Mary Ellen Grant said.
Kaiser Permanente, the state’s largest insurer, has already sent employers information they can provide to their employees about the new benefit, company spokesperson Kathleen Chambers said. She added that eligible members whose plans renew on or after July 1 would have IVF coverage if implementation of the law is not delayed.
Employers and some fertility care providers appear to be grappling over the uncertainty of the law’s start date. Amy Donovan, a lawyer at insurance brokerage and consulting firm Keenan & Associates, said the firm has fielded many questions from employers about the possibility of delay. Reproductive Science Center and Shady Grove Fertility, major clinics serving different areas of California, posted on their websites that the IVF mandate had been delayed until January 2026, which is not yet the case. They did not respond to requests for comment.
Some infertility patients confused over whether and when they will be covered have run out of patience. Ana Rios and her wife, who live in the Central Valley, had been trying to have a baby for six years, dipping into savings for each failed treatment. Although she was “freaking thrilled” to learn about the new law last fall, Rios could not get clarity from her employer or health plan on whether she was eligible for the coverage and when it would go into effect, she said. The couple decided to go to Mexico to pursue cheaper treatment options.
“You think you finally have a helping hand,” Rios said of learning about the law and then, later, the requested delay. “You reach out, and they take it back.”
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content is presented in a factual, balanced manner typical of center-left public policy reporting. It focuses on a progressive healthcare issue (mandated IVF insurance coverage) favorably highlighting benefits for diverse family structures and individuals, including same-sex couples and single parents, which often aligns with center-left values. At the same time, it includes perspectives from government officials, industry representatives, opponents, and patients, offering a nuanced view without overt ideological framing or partisan rhetoric. The emphasis on healthcare access, social equity, and patient impact situates the coverage within a center-left orientation.
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Mississippi airports working to complete projects
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News from the South - Kentucky News Feed6 days ago
Kentucky State Police takes to the skies in National Cruiser Contest
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News from the South - Arkansas News Feed6 days ago
Beyoncé handles car tilting in air during Houston show
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News from the South - Arkansas News Feed7 days ago
Local Party Leaders Response to Trump's Bill
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News from the South - Louisiana News Feed4 days ago
Attorneys who run public defender offices replaced amid contract turmoil
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News from the South - Oklahoma News Feed6 days ago
Man caught stealing $3K worth of fireworks from stand
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Local News6 days ago
Fourth Annual “Big T Invitational” in memory of Thomas Miller raises 10-thousand dollars for UAB Hospital