Claire Cleveland, Author at KFF Health News https://kffhealthnews.org Fri, 11 Oct 2024 11:46:45 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 https://kffhealthnews.org/wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Claire Cleveland, Author at KFF Health News https://kffhealthnews.org 32 32 161476233 Colorado’s Naloxone Fund Is Drying Up, Even as Opioid Settlement Money Rolls In https://kffhealthnews.org/news/article/naloxone-colorado-overdose-opioids-settlement-bulk-fund/ Fri, 11 Oct 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1926367 DENVER — On a bustling street corner one recent afternoon outside the offices of the Harm Reduction Action Center, employees of the education and advocacy nonprofit handed out free naloxone kits to passersby.

Distributing the opioid reversal medication is essential to the center’s work to reduce fatal overdoses in the community. But how long the group can continue doing so is in question. The center depends on Colorado’s Opioid Antagonist Bulk Purchase Fund, also known as the Naloxone Bulk Purchase Fund, which now lacks a recurring source of money — despite hundreds of millions of dollars in national opioid lawsuit settlement cash flowing into the state.

“Our concern is that we won’t have access to naloxone, and that means that more people will die of a very preventable overdose,” said Lisa Raville, executive director of the center.

The bulk fund was created in 2019 to provide free naloxone to organizations like the Harm Reduction Action Center. The fund’s annual budget grew from just over $300,000 in fiscal year 2019 to more than $8.5 million in fiscal 2022, according to legislative reports by the state’s Overdose Prevention Unit.

The fund has boosted the availability of the medication throughout Colorado, which passed a law in 2013 that gives legal immunity to medical providers who prescribe the drug and to any person who administers it to someone suffering an overdose. The fund currently provides more than $550,000 worth of naloxone kits to various entities each month.

Despite the increased availability of naloxone, fatal opioid overdoses continued to rise. In 2023, 1,292 people in Colorado died of an opioid overdose, according to data from the Colorado Department of Public Health and Environment. That was 132 more people than the year before.

And now, one of the fund’s major money sources, the American Rescue Plan passed by Congress in response to the covid-19 pandemic, is set to expire next year. As of September, the Colorado fund had $8.6 million left, according to Vanessa Bernal, a spokesperson for the state health department.

The fund got a boost in September when the state’s Behavioral Health Administration provided it with $3 million from a one-time Substance Use Prevention, Treatment, and Recovery Services Block Grant and nearly $850,000 through a State Opioid Response Grant. Colorado Attorney General Phil Weiser said his office will “ensure that the necessary budget remains in place for the next year.”

The amount of that funding and where it will come from has yet to be determined, and long-term solutions are still being weighed, as well. One option to shore up the fund beyond the next year is to use Colorado’s share of settlement funds from the national opioid lawsuits, said Mary Sylla, former director of overdose prevention policy and strategy at the National Harm Reduction Coalition.

“It’s just completely ironic that something that addresses the opioid overdose crisis is underfunded at the very same time that these settlement funds are flowing,” Sylla said. “There couldn’t be a better use for them.”

As of July, Colorado had received and distributed more than $110 million in opioid settlement money to regions, local governments, state entities, and infrastructure projects, according to the Colorado attorney general’s office, and the total is expected to reach more than $750 million by 2038.

However, more than half of the settlement money Colorado has received thus far has already been disbursed to its 19 Regional Opioid Abatement Councils, which have created their own plans to distribute money to programs such as substance abuse treatment centers, public education campaigns, and training for emergency providers.

For example, Denver’s council, which has received more than $18 million since 2022, has disbursed money to organizations in two- and three-year contracts, the majority not including the purchase of naloxone.

“We thought we could all continue to get [naloxone] from the state health department and the Naloxone Bulk Purchase Fund,” Raville said.

The Denver council is working on a plan for the coming years, expected to come out in mid-2025, and is considering the bulk fund’s dwindling money, said Marie Curran, program coordinator for Denver’s opioid abatement funds.

Lawrence Pacheco, a spokesperson for the attorney general’s office, which manages 10% of the state’s opioid settlement dollars, said the office “is working on options to ensure that this lifesaving medication can continue to be part of the state’s effort to abate the opioid crisis.” Those options have not yet been made public.

California, where Sylla works, has used settlement money for a distribution program that’s similar to Colorado’s. In Washington and Kentucky, as part of the states’ settlements with Teva Pharmaceuticals, tens of thousands of free naloxone kits will be available to residents. Each state uses its opioid settlement funds differently, and while many provide naloxone to residents in some manner, including via vending machines, there is no central tracking of naloxone distribution programs.

Over the past five years, Colorado’s fund has distributed more than half a million doses of the opioid reversal drug to hundreds of organizations and schools across the state. Last year, the Harm Reduction Action Center received 7,284 doses from the fund, which Raville estimates helped save more than 4,500 lives.

Unless additional money is found, the bulk fund runs the risk of having to further limit distribution, leaving the hundreds of organizations that rely on it with little or no access to free naloxone. While the medication became available over the counter nationally last fall, the $45 price tag per two-dose package means it can remain out of reach for some who need it most.

In May, the state announced a plan for prioritizing which groups get the medication from the bulk fund, with four categories, from “essential” to “low need,” based on how frequently an entity directly encounters people who are most at risk of experiencing or witnessing an overdose. The Harm Reduction Action Center has been classified in the “essential” category. School districts, as well as colleges and universities, are in the next-highest category.

Another organization, The Naloxone Project, said it was misclassified by not being put at the highest priority level. As a result, it said, it received just 1,200 naloxone doses from the fund this year, instead of the 6,000 it requested.

“We would argue that we would fall under ‘essential’ because many of our programs are public-facing and consistently provide naloxone for people who use drugs and who are at the highest risk of experiencing overdose,” said Rachael Duncan, associate director of The Naloxone Project.

The group, which has chapters in 12 states, provides nasal and injectable forms of naloxone to more than 90% of Colorado’s hospitals, to give to patients before they are discharged from the emergency department or from labor and delivery units. More than half of the 12,000 naloxone kits the project has distributed to Colorado medical entities have come from the bulk fund.

Another organization, UCHealth’s Center for Dependency, Addiction and Rehabilitation, known as CeDAR, which offers residential, outpatient, and telehealth treatment, is no longer eligible to receive free naloxone, because its patients typically are insured or can pay out-of-pocket.

Karli Yarnell, a CeDAR physician assistant, said that even when someone can pay for it, that doesn’t mean they can get to a pharmacy to pick up the medicine.

And Duncan is concerned about what the loss of doses will mean for organizations like The Naloxone Project and CeDAR.

“What I fear will happen is a scarcity mindset of organizations competing for funding,” Duncan said. “But I also worry about places that are used to getting it so reliably running out.”

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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Colorado Becomes the First State to Ban So-Called Abortion Pill Reversals https://kffhealthnews.org/news/article/mifepristone-abortion-pill-reversal-progesterone-colorado-ban/ Thu, 04 May 2023 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1678490 In Glenwood Springs, Colorado, registered nurse Katie Laven answers calls from people who’ve started the two-pill medication abortion regimen and want to stop the process.

“They are just in turmoil,” said Laven, who works at the Abortion Pill Rescue Network and answers some of the roughly 150 calls it says come in each month. “They feel like, ‘Well, maybe an abortion would make it better.’ And then they take the abortion pill and they’re like, ‘I don’t feel better. In fact, I feel much worse that I did that.’”

The Abortion Pill Rescue Network is run by Heartbeat International, an anti-abortion group that promotes a controversial practice called abortion pill reversal, in which a patient is given progesterone within 72 hours of taking mifepristone, the first pill administered in a medication abortion, and before taking misoprostol, the second pill. The organization said more than 4,000 infants have been born since 2013 after people went through the reversal process. KFF Health News couldn’t independently verify that number, which Heartbeat International said is based on internal patient data.

But such interventions may be coming to an end in Colorado, which recently became the first state to ban abortion pill reversals. The Colorado legislature passed a bill to make prescribing any drug in this way medical misconduct, unless three of the state’s medical boards find it is a “generally accepted standard of practice.” Democratic Gov. Jared Polis signed the bill into law on April 14.

The bill also limits advertising by pregnancy resource centers, which do not offer abortions; rather, they are known to try to talk people out of getting an abortion.

The Colorado attorney general’s office, several district attorneys, the Colorado Medical Board, and the Colorado Board of Nursing said they would not enforce the new law until the two medical boards determine whether abortion reversal is “a generally accepted standard of practice,” The Colorado Sun reported.

Pills have emerged as the latest front in the war over abortion since the U.S. Supreme Court overturned Roe v. Wade in June 2022. In early April, a federal judge in Texas ruled to halt access to mifepristone nationwide, a decision later stayed by the Supreme Court.

“The push to promote so-called medication abortion reversal is part of a larger strategy that aims to misinform the public about abortion safety, about the effectiveness of abortion methods, about people who are seeking abortion care and how sure they are of their decision,” said Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH) at the University of California-San Francisco. “All of that misinformation has played an important role in eroding people’s rights to this essential component of health care.”

For Laven, the nurse who works for the Abortion Pill Rescue Network hotline, abortion pill reversal is another aspect of patient choice.

“We should not be forcing them to continue,” she said of pregnant people. “We should give them the choice to stop if they want.”

In 2020, medication abortion accounted for more than half of all documented abortions, according to the Guttmacher Institute, a research organization that supports abortion rights. During the pandemic, the FDA eliminated a long-standing rule that abortion pills be picked up in person, paving the way for patients to receive them in the mail.

There is no comprehensive public data on how often a person takes the first abortion pill then changes their mind. Andrea Trudden, Heartbeat International’s vice president of communications and marketing, said in a statement that about 150 women a month start the reversal process through its network, but she did not respond to requests for more details.

“No woman should be forced to complete an abortion she no longer wants,” Trudden said. “Imagine knowing that there is a way you can try to save your baby and not be allowed to. It’s not right.”

Abortion rights advocates said patients do sometimes change their minds, even though doctors typically counsel patients beforehand that it’s not a reversible process. Doctors can recommend that they induce vomiting if less than an hour has passed since taking mifepristone or else tell them to forgo the second pill, misoprostol. They also cited ANSIRH’s Turnaway Study, which tracked more than 600 people who had abortions in the United States for five years afterward, and found that more than 95% felt abortion had been the right decision for them.

Abortion pill reversal is “not based on science,” according to the American College of Obstetricians and Gynecologists, which says mandates “based on unproven, unethical research” are dangerous to women’s health care. By 2021, 14 states had enacted laws that required patients to receive information on abortion pill reversal, largely during pre-abortion counseling, according to a study in the American Journal of Public Health.

Earlier this month, the Republican-controlled Kansas legislature passed a bill that would require providers to tell patients that medication abortions are reversible once underway. The bill was vetoed by the state’s governor then overridden by the legislature. It goes into effect in July.

The practice is also not supported by the American Medical Association, which filed a lawsuit in North Dakota in 2019 challenging two laws that required physicians to tell patients about abortion pill reversal and that abortion terminates “the life of a whole, separate, unique, living human being.” That case is pending while a separate lawsuit challenging North Dakota’s abortion ban plays out.

Proponents of abortion pill reversal point to a case study led by an anti-abortion physician, George Delgado, president of the Steno Institute, a nonprofit devoted to what the institute calls “pro-life” research. The retrospective analysis reviewed 547 cases and found 64%-68% of patients given progesterone continued their pregnancies after taking mifepristone.

But the study elicited criticism for several reasons, including its methods and lack of safety data. Mifepristone alone is not a very effective abortifacient, according to ANSIRH. In a 1988 study that looked at continued pregnancy in 30 women after they took 200 milligrams of mifepristone, 23% of women continued their pregnancies. The women in that study were no more than seven weeks pregnant.

Delgado’s analysis compared its continued-pregnancy rate, which included women who were anywhere from five to nine weeks pregnant, to that study. Grossman and other authors who reanalyzed the Delgado case series at seven weeks gestation found no significant difference in patients who took progesterone reversal treatment and those who took only mifepristone.

“For now, any use of reversal treatment should be considered experimental and offered only in the context of clinical research supervised by an institutional review board,” Grossman and a co-author wrote in a paper in the New England Journal of Medicine.

In 2020, researchers from the University of California-Davis set out to evaluate abortion pill reversal treatment in a controlled trial. That study ended early due to safety concerns. Three women, two in the control group and one in the experimental group who received progesterone, hemorrhaged.

“It’s a very small study, so it’s hard to draw a definitive conclusion, but it certainly is concerning,” said Grossman. “And it’s surprising that all of the reports that have come from Delgado, including the largest case series, don’t have any reports of patients having heavy bleeding. And that just really makes me concerned that they weren’t adequately capturing those kinds of safety outcomes.”

Delgado, who is a plaintiff in the Texas case against mifepristone, refuted the arguments against his research. He said the case study is one piece of evidence to support abortion pill reversal, alongside other safe uses of progesterone, animal case studies, and the more than 4,000 reversals documented by Heartbeat International.

“Abortion pill reversal has been demonstrated to be safe. It’s been demonstrated to be effective,” he said. “And in my experience in talking to women that I’ve treated, and in talking to other women who have been treated by others, women who are given that opportunity to reverse their chemical abortions have expressed great gratitude. And I’ve never had a woman tell me that she regretted attempting to reverse her chemical abortion.”

Colorado legislators targeted pregnancy resource centers and abortion pill reversal as part of a broader package of abortion rights policy proposals. The other bills in the package protect providers and patients of abortion care and gender-affirming care and expand funding for abortion services, both of which Polis signed into law.

Last year, the Democratic-led legislature passed the Reproductive Health Equity Act, which codified the right to an abortion and contraceptives in state law and declared that an embryo or fetus does not have rights under state law.

As a result of those protections and bans in neighboring states, Colorado has seen an influx of out-of-state patients seeking abortions. In 2022, 3,835 people from out of state received abortions in Colorado, according to provisional data from the state Department of Public Health and Environment. That is 2,275 more people than state officials recorded the year before.

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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Community Resurrects Colorado Birth Center Closed by Private Equity Firm https://kffhealthnews.org/news/article/community-resurrects-colorado-birth-center-closed-by-private-equity-firm/ Thu, 09 Feb 2023 10:00:00 +0000 https://khn.org/?post_type=article&p=1615814 [UPDATED on Feb. 13]

When a private equity firm closed Seasons Midwifery and Birth Center in Thornton, Colorado, in October, the state lost one of its few non-hospital birthing centers and 53 families with pregnancy due dates in November and December were left scrambling to find providers.

But then staffers and community advocacy groups stepped in to fill the void for the suburban Denver community and its patients, many of whom rely on Medicaid, the federal-state insurance program for people with low incomes. They reorganized Seasons as a nonprofit organization and struck a note of triumph and defiance in announcing its reopening in January as the free-standing Seasons Community Birth Center. Seasons has five deliveries scheduled in February and 30 between March and July.

“With the closing, we decided we’re not going to let capitalism take us down,” said Justina Nazario, a Seasons birth assistant. “We’re going to bring these really important qualities that you don’t get in the medical-industrial complex.”

Over the past two decades, the number of at-home and birth center deliveries nationwide was on the rise — until the covid-19 pandemic hit. The number of out-of-hospital births increased 22% from 2019 to 2020 and an additional 12% from 2020 to 2021, according to a Centers for Disease Control and Prevention report.

Nationally, birth centers — medical facilities for labor and childbirth that rely on midwives to help with healthy, low-risk pregnancies — have lower rates of preterm births, low birth weights, and women transferred to hospitals for cesarean sections.

While C-sections can be lifesaving, they are major surgeries that come with significant risk and cost. A 2013 study of about 22,400 women who planned to give birth at a birth center found that 6% of those who entered labor at such a facility were sent to a hospital for a C-section. By contrast, about 26% of healthy, low-risk pregnancies in hospitals end in C-sections.

Before Seasons closed, staffers transferred about 8% of patients to a hospital for a C-section.

The funding model for birthing centers is complicated: In Colorado they are regulated and licensed by the state health department, yet because they’re not hospitals, they can’t bill insurance in the same way as a hospital. So Seasons, for example, receives about $4,000 per birth from private insurance, said Heather Prestridge, the clinic’s administrative director, while a hospital birth costs on average $19,000 and is reimbursed by insurance for about $16,000.

The only option for patients who don’t have private insurance and cannot pay out-of-pocket is to deliver in a hospital. Most birth centers don’t accept Medicaid, but Seasons is different. Before its closure, about 40% of its clients were on Medicaid, which reimburses less than other insurance providers, Prestridge said.

“Every time we take a Medicaid client on, we lose money,” Prestridge said. “It’s so important for everyone to have access to this kind of care, so we continue to do it anyway.”

Medicaid’s restrictions and low reimbursement rates have led to financial problems for birth centers, including Seasons, despite their being inundated with patients. In Colorado, 19% of the population and 36% of births were covered by Medicaid in 2022.

As a nonprofit, Seasons will need to lean on fundraising to fill the gaps, Prestridge said.

Colorado has seven birth centers, including Seasons, which often have rooms that look more like bedrooms than hospital rooms, and bathtubs as an option for delivery.

In 2018, two other Colorado birth centers — associated with hospital groups but owned by a for-profit parent company — closed. The two Denver-area practices primarily served patients who had low incomes or were refugees, according to The Colorado Sun.

“It came as a shock to us, but unfortunately it has become our reality,” Miki Tynan, co-founder and managing director of Colorado Birth and Wellness said of the birth center closures.

When Seasons closed Oct. 4, Colorado Birth and Wellness, a collaboration between two birth centers in the Denver area, took on more than 60 of its clients.

The physicians group that started Seasons in 2019, called Women’s Health Group, partnered with a private equity group, Shore Capital Partners, in late 2020 and became Elevate Women’s Health. Executives there determined that Seasons was unprofitable and closed it, said Aubre Tompkins, clinical director at Seasons Community Birth Center, and others who worked for Seasons at the time.

“It was pretty devastating,” Tompkins said. “There were a lot of tears, there was a lot of anger, there was a lot of confusion.”

After the closure was announced, Elephant Circle, a reproductive justice organization, reached out to Tompkins with a plan to raise money for Seasons to reopen as a nonprofit. The organization’s founder, Indra Lusero, said members wanted to save Seasons but also wanted to invest in making the nonprofit model work more broadly.

“There’s been some investment, there’s been federal studies, there’s great data — all the things saying, ‘Hey, I think this model looks like it could work. We should invest in this model,’” Lusero said.

As a nonprofit, Seasons plans to expand its services to include gender-affirming care and train more people as midwives and doulas to increase diversity in the field. Seasons offers annual gynecological exams, contraceptives, lactation services, and newborn care through the first two weeks of life.

Tompkins is a member of what she described as an emergency and temporary task force that reopened the facility with a reproductive justice mission. Nazario will also sit on the board, along with representatives from the Colorado Organization for Latina Opportunity and Reproductive Rights, or COLOR; Elephant Circle; and Soul 2 Soul Sisters, a racial justice organization.

Nazario, who describes herself as Afro-Latina, has experienced firsthand how essential her identity and experiences are to her work in birthing. Potential clients often reach out to her saying they had been looking for someone like her, someone like them.

Katherine Riley, who gave birth to her daughter at Seasons last year, is policy director at COLOR and a member of the Seasons Community Birth Center board. She said she’s excited to advance Seasons’ mission and expand teaching opportunities for future midwives.

“The practice of midwifery, I think, in itself is an act of resistance,” Riley said. “There’s a long history of racism and patriarchy in ousting midwives, and so I think returning as a community to that is so important.”

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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