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With other GOP presidential candidates following Donald Trump’s lead in calling for an end to the Affordable Care Act, Democrats are jumping on an issue they think will favor them in the 2024 elections. The Biden administration almost immediately rolled out a controversial proposal that could dramatically decrease the price of drugs developed with federally funded research dollars. The drug industry and the business community at large are vehemently opposed to the proposal, but it is likely to be popular with voters.
Meanwhile, the Supreme Court hears arguments in a case to decide whether the Sackler family should be able to shield billions of dollars taken from its bankrupt drug company, Purdue Pharma, from further lawsuits regarding the company’s highly addictive drug OxyContin.
This week’s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Alice Miranda Ollstein of Politico, and Rachana Pradhan of KFF Health News.
Among the takeaways from this week’s episode:
The ACA may end up back on the proverbial chopping block if Trump is reelected. But as many in both parties know, it is unlikely to be a winning political strategy for Republicans. ACA enrollment numbers are high, as is the law’s popularity, and years after a failed effort during Trump’s presidency, Republicans still have not unified around a proposal to replace it.
Democrats are eager to capitalize on the revival of “repeal and replace.” This week, the Biden administration announced plans to exercise so-called “march-in rights,” which it argues allow the government to seize certain patent-protected drugs whose prices have gotten too high and open them to price competition. The plan, once largely embraced by progressives, could give President Joe Biden another opportunity to claim his administration has proven more effective than Trump’s heading into the 2024 election.
The Senate voted to approve more than 400 military promotions this week, effectively ending the 10-month blockade by Republican Sen. Tommy Tuberville of Alabama over a Pentagon policy that helps service members travel to obtain abortions. At the state level, the Texas courts are considering cases over its exceptions to the state’s abortion ban, while in Ohio, a woman who miscarried after being sent home from the hospital is facing criminal charges.
Meanwhile, the Supreme Court soon could rule on whether EMTALA, or the Emergency Medical Treatment and Labor Act, requires doctors to perform abortions in emergencies. And justices are also considering whether to allow a settlement deal to move forward that does not hold the Sacker family accountable for the harm caused by opioids.
Also this week, Rovner interviews Dan Weissmann, host of KFF Health News’ sister podcast, “An Arm and a Leg,” about his investigation into hospitals suing their patients for unpaid medical bills.
Former president and current 2024 Republican front-runner Donald Trump is aiming to put a repeal of the Affordable Care Act back on the political agenda, much to the delight of Democrats, who point to the health law’s growing popularity.
Meanwhile, in Texas, the all-Republican state Supreme Court this week took up a lawsuit filed by more than two dozen women who said their lives were endangered when they experienced pregnancy complications due to the vague wording of the state’s near-total abortion ban.
This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of Johns Hopkins University and Politico Magazine, Victoria Knight of Axios, and Sarah Karlin-Smith of the Pink Sheet.
Among the takeaways from this week’s episode:
The FDA recently approved another promising weight loss drug, offering another option to meet the huge demand for such drugs that promise notable health benefits. But Medicare and private insurers remain wary of paying the tab for these very expensive drugs.
Speaking of expensive drugs, the courts are weighing in on the use of so-called copay accumulators offered by drug companies and others to reduce the cost of pricey pharmaceuticals for patients. The latest ruling called the federal government’s rules on the subject inconsistent and tied the use of copay accumulators to the availability of cheaper, generic alternatives.
Congress will revisit government spending in January, but that isn’t soon enough to address the end-of-the-year policy changes for some health programs, such as pending cuts to Medicare payments for doctors.
“This Week in Medical Misinformation” highlights a guide by the staff of Stat to help lay people decipher whether clinical study results truly represent a “breakthrough” or not.
Also this week, Rovner interviews KFF Health News’ Rachana Pradhan, who reported and wrote the latest “Bill of the Month” feature, about a woman who visited a hospital lab for basic prenatal tests and ended up owing almost $2,400. If you have an outrageous or baffling medical bill you’d like to share with us, you can do that here.
On the presidential campaign trail, Republican Ron DeSantis touts himself as a champion of medical freedom, outlawing vaccine mandates and protecting doctors who refuse to provide certain medical treatments on moral grounds.
His record as Florida’s governor suggests a presidency that would prioritize individual freedom over public health, but his push for such freedoms ends when it comes to abortion and treatment for gender dysphoria. In Florida, he has pushed restrictions on those medical services.
Critics contend those were the wrong priorities in a state where 7.4% of children had no medical insurance as of 2022. Since then more than 250,000 Florida children have lost the health insurance they had through Medicaid.
The DeSantis campaign did not return multiple requests for comment on the governor’s health policy campaignplans.
As he sets his sights on the White House, here’s a recap of his health care record:
Subscribe to KFF Health News’ free Morning Briefing.
Public Health
At campaign stops, DeSantis talks often of his handling of the covid-19 pandemic even as the issue has largely disappeared from the public’s radar.
DeSantis initially followed federal health guidance and ordered a statewide lockdown in April 2020. But the governor quickly changed course, beginning a phased reopening of Florida just one month later. Around then, Florida’s then-surgeon general, Scott Rivkees, was hustled out of a news conference and hardly seen for months after he said residents might have to socially distance themselves from others and wear masks until vaccines became available.
DeSantis did initially champion covid-19 vaccines, especially for Florida’s older adults. That changed in 2021, when DeSantis appointed Joseph Ladapo as his next surgeon general. A Harvard-trained doctor, Ladapo had gained prominence as a skeptic of the scientific consensus on how to treat and prevent the spread of the virus.
Subsequently, Florida was the only state not to preorder covid-19 vaccine doses for children under 5 when those became available in 2022. At news conferences, DeSantis publicized covid-19 treatments such as monoclonal antibodies but didn’t urge residents to get vaccinated.
Later, DeSantis’ health department recommended against vaccines for young men and against people under 65 getting updated vaccines, guidance that contradicted that of the U.S. Centers for Disease Control and Prevention.
DeSantis as president would likely downplay the importance of the CDC, which is an advisory body, and instead might require states to invest more in public health infrastructure, said Jay Wolfson, a public health professor at the University of South Florida.
The pandemic exposed that Florida’s public health system had been underfunded and largely ignored by successive administrations, including DeSantis’, Wolfson said. Having led Florida through hurricanes Ian and Idalia, DeSantis may want a similar response to public health emergencies like covid-19, where states take the lead and the federal government’s role is to support them, he said.
Abortion
DeSantis has said he supports a “culture of life.” As governor, he’s signed the most anti-abortion modern-day legislation Florida has seen. But he has faced pushback from the anti-abortion crowd for his initial reluctance to endorse a federal ban and from other anti-abortion Republicans for signing a ban on most abortions after six weeks of pregnancy, which some have said is too extreme.
That bill, which DeSantis signed this year, has exceptions for rape, incest, and human trafficking up to 15 weeks into the pregnancy if the woman seeking an abortion has documentation proving her circumstances.
That bill has not taken effect, because of a pending court challenge over Florida’s current 15-week abortion ban, which DeSantis signed in 2022. That law does not have any exceptions for victims of rape or incest but does have exceptions for the health of the mother.
Opponents of Florida’s abortion restrictions say the threat of a felony arrest for violating the law makes it difficult for a doctor to provide an abortion they think is necessary.
After months of declining to directly answer whether he would support a nationwide abortion ban, DeSantis said during the second GOP presidential primary debate that he would sign a 15-week federal abortion ban.
The issue remains a difficult one for Republicans. A recent successful ballot measure in Ohio suggests that preserving abortion rights remains an effective issue for Democrats to drive turnout.
With Florida’s ban held up in legal challenges, the state continues to be one of the biggest providers of abortions in the Southeast. About 65,000 abortions have been recorded by the Florida Agency for Health Care Administration so far this year. Almost 6,000 were for out-of-state residents.
Medicaid
Even as states long opposed to Medicaid expansion such as South Dakota and North Carolina have recently reversed course, Florida remains in a group of 10 holdout states that refuse to expand the program as part of the Affordable Care Act.
The act provides extra federal funding to states that increase eligibility. In Florida’s case, doing so would help an estimated 514,000 residents gain health coverage, according to an October analysis by the Urban Institute.
Florida has had one of the highest child uninsured rates for many years, higher than poorer states such as neighboring Alabama, another state that has refused to expand Medicaid, said Joan Alker, executive director at the Georgetown University Center for Children and Families.
Almost 823,000 Floridians have lost Medicaid coverage since April, when states could remove recipients for the first time since the pandemic began. That includes at least 250,000 children. It’s unknown how many of those children are now covered through their parents’ insurance. But despite the state’s reassurance that kids who lose coverage would be referred to child health insurance programs like KidCare, Democratic state and federal lawmakers point to enrollment in the state program rising by only 25,000 children.
Florida is also the only state that has not taken advantage of federal waivers that would enable the state to keep more people on Medicaid while it transitions back to normal Medicaid operation.
Wolfson said Florida’s position reflects DeSantis’ belief that the program has become “an expensive and overextended giveaway” that discourages people from working hard to better their lives.
“We’re not going to be like California and have massive numbers of people on government programs without work requirements,” DeSantis said during the second Republican debate when asked why Florida’s uninsured rate — 11.2% in 2022, according to U.S Census Bureau estimates — was higher than the national average, which was 8%.
DeSantis has, however, approved bills that expanded Medicaid coverage based on needs, an approach that may be more illustrative of his handling of the health insurance program should he end up in the White House.
In 2021, DeSantis signed a bill to extend postpartum Medicaid coverage to up to 12 months. This year, he approved legislation for Medicaid to cover glucose monitors and for family members who are 18 or older to be able to be trained and paid under Medicaid as home health aides for medically fragile child relatives.
DeSantis also signed a bill to make more lower-income families eligible for KidCare, a set of child health insurance programs.
Gender Dysphoria Care
Like other GOP-led states, Florida has restricted the rights of transgender minors to access treatments such as puberty blockers and hormone therapy.
Florida health officials in 2022 approved rules prohibiting minors from accessing treatment for gender dysphoria. They then in 2023 prohibited minors from accessing that treatment even in clinical trials.
This past legislative session, Florida lawmakers passed a bill codifying that rule, which DeSantis signed into law. The decision runs counter to recommendations from major medical organizations. The legislation also requires that, for adults, gender dysphoria care, which the state calls “sex-reassignment prescriptions or procedures,” can be administered only by a physician.
In 2022, DeSantis’ administration published a report that created the foundation for a rule that prohibited Medicaid from covering gender dysphoria treatments for both minors and adults. To create the report, the Florida health agency veered from its standard protocol and brought in consultants who had known views that ran counter to major medical organizations’ guidance.
A judge has since struck that Medicaid ban down, but lawyers are arguing in court that DeSantis’ administration has been willfully defying the order and has continued to implement the Medicaid ban.
Medical Freedom
Earlier this year, DeSantis declared Florida the “medical freedom” state as he signed into law protections for medical providers who turn away patients on “conscience” grounds.
The law provides similar protections for insurance companies.
Opponents of the legislation worry it will allow doctors to discriminate against LGBTQ+ people or other groups. The legislation does not allow someone to opt out of providing care because of “race, color, religion, sex, or national origin.”
Federal laws protect health care workers from having to provide abortions if doing so goes against their personal beliefs. Florida’s new law is much broader, allowing a medical professional to deny nearly any procedure if it goes against their conscience.
This article was produced in partnership with the Tampa Bay Times.
Midwest KHN correspondent Bram Sable-Smith discussed the Eli Lilly news on insulin prices on “PBS NewsHour” and insulin prices on Slate’s “What Next” on March 1.
KHN contributor Andy Miller discussed Georgia’s legislative wrap-up including Medicaid work requirements on Georgia Public Broadcasting’s “Lawmakers” on Feb. 28. He also discussed health care for foster children on WUGA’s “The Georgia Health Report” on Feb. 3.
Senior KHN correspondent Julie Appleby discussed how the end of the public health emergency will affect costs for covid-19 vaccines, treatments, and masks on KMOX’s “Health Matters” on Feb. 25.
KHN correspondent Cara Anthony discussed the youngest victims of gun violence and those who dig their graves on America’s Heroes Group on Feb. 25.
KHN contributor Eric Berger discussed distracted driving laws and why Missouri still doesn’t have one on St. Louis Public Radio’s “St. Louis on the Air” on Feb 24.
It was the first day of her family’s vacation in the San Juan Islands last June when Danielle Laskey, who was 26 weeks pregnant, thought she was leaking amniotic fluid.
A registered nurse, Laskey called her OB-GYN back home in Seattle, who said to seek immediate care. Staff members at a nearby emergency department found no leakage. But her OB-GYN still wanted to see her as soon as possible.
Laskey and her husband, Jacob, made the three-hour trip to the Swedish Maternal & Fetal Specialty Center-First Hill. Laskey had sought the clinic’s specialized care for this pregnancy, her second, after a dangerous complication with her first: The placenta had become embedded in the uterine muscles.
Back in Seattle, doctors at the clinic found Laskey’s water had broken early, posing a serious risk to her and the fetus, and ordered her immediate admission to Swedish Medical Center/First Hill. She delivered her son after seven weeks in the hospital. Though she was treated for multiple postpartum complications, she was well enough to be discharged the next day. Her son, who is healthy, went home a month later.
Laskey soon developed a fever and body aches, and she was told by her OB-GYN to go to Swedish’s emergency department. She said doctors there wanted to admit her when she arrived Aug. 20 and scheduled a procedure for Aug. 26 to remove a fragment of placenta that her body had not eliminated on its own.
Laskey, who had already spent weeks away from her 3-year-old daughter, chose to go home. She returned for the procedure, which went well, and she was home the same day.
Then the bills came.
The Patient: Danielle Laskey, 31, was covered by a state-sponsored plan offered by her employer, a local school district, and administered by Regence BlueShield.
Medical Service: In-patient hospital services for 51 days, plus a one-day stay that included a second placenta removal procedure.
Service Provider: Swedish Medical Center/First Hill, part of Providence Health & Services, a large, nonprofit, Catholic health system.
Total Bill: Swedish, through Regence, billed about $120,000 in cost sharing for Laskey’s initial hospitalization and about $15,000 for her second visit and procedure.
What Gives: The specialized clinic caring for Laskey before her hospital admission was in her insurance plan’s network. The clinic’s doctors admit patients only to Swedish Medical Center, one of the Seattle area’s only specialized providers for Laskey’s condition — which, given that connection, she assumed was also in the network.
So after being urgently admitted to Swedish, Laskey believed her bills would be largely covered, with the couple expected to pay $2,000 at most for their portion of in-network care because of her plan’s out-of-pocket cost limit.
It turned out Swedish was out of network for Laskey’s plan and, at first, Regence determined that Laskey’s hospitalizations were not emergencies. In November, a Regence case manager initially told Jacob that Laskey’s lengthy hospitalization was an emergency admission and out-of-network charges would not apply. But then she called back and said the charges would apply after all, because Laskey had not come in through the emergency department.
Both Washington state and federal laws prohibit insurers and providers from billing patients for out-of-network charges in emergency situations. The couple said neither Swedish nor Regence told them before or during the two hospitalizations that Swedish was out of network, and that they never knowingly signed anything agreeing to accept out-of-network charges.
Jacob, who works as a psychiatrist at a different hospital, said he mentioned the surprise-billing laws to the case manager, but she replied that the laws did not apply to his family’s situation.
It was only after Regence was contacted by KHN that the insurer explained its reasoning to the reporter: Regence said the Swedish hospital, while out of network for Danielle, had a broader contract with the insurer as a “participating provider” and so the insurer was not in violation of surprise-billing laws by approving Swedish’s out-of-network coinsurance charges.
The broader contract allowed Swedish to bill members of any Regence plan who receive out-of-network services there 50% coinsurance — the patient’s portion of the overall cost the insurer allows the provider to charge — with no out-of-pocket maximum for the patient.
What’s the difference between a hospital that’s “in network” and one that’s a “participating provider”? In this case, by contracting with Regence as an out-of-network but also participating provider, Swedish straddled the line between being in and out of network — designations that traditionally indicate whether a provider has a contract with an insurer or not.
Setting the terms with an insurer for providing its members emergency or other care appears to allow hospitals to sidestep new surprise-billing laws that prevent out-of-network providers from charging high, unpredictable rates in emergencies, according to government and private-sector medical billing experts.
Experts said they had not heard of out-of-network providers evading surprise-billing laws by being contracted as “participating providers” until KHN asked about Laskey’s case.
Ellen Montz, director of the Center for Consumer Information and Insurance Oversight at the Centers for Medicare & Medicaid Services, said that under the federal No Surprises Act the definition of a “participating” emergency facility that’s subject to the law’s surprise billing protections depends on whether the facility has a contract with the insurer specifying the terms and conditions under which an emergency service is provided to a plan member.
Matthew Fiedler, a senior fellow at the University of Southern California-Brookings Schaeffer Initiative for Health Policy who studies out-of-network billing, said Laskey’s case seems to fall into a “weird” gray area of the state and federal laws protecting patients from out-of-network charges in emergency situations.
If there had been no contract between Regence and Swedish, the laws clearly would have prohibited those charges. But since there was a contract specifying a 50% coinsurance rate when Swedish was out of network for a particular Regence plan, those laws legally may not apply, Fiedler said.
After he declined to apply for the hospital’s financial assistance program, Jacob said Swedish also notified the couple in November that they had two months to pay or be sent to collections.
Natalie Kozimor, a spokesperson for Providence Swedish, said the hospital disagreed with “some of the details and characterizations of events” presented by the Laskeys, though she did not specify what those were. She said Swedish assisted Danielle with her appeal to Regence.
“We had no luck with Swedish taking any role or responsibility with regard to our billing or advocating on our behalf,” Jacob said. “They basically just referred us to their financial department to put us on a payment plan.”
Danielle Laskey at her home just outside Seattle, with her infant son.(Ryan Henriksen for KHN)
The Resolution: In December, the couple appealed Regence’s approval of Swedish’s out-of-network charges for the 51-day hospitalization, claiming it was an emergency and that there was no in-network hospital with the expertise to treat her condition. They also filed a complaint with the state insurance commissioner’s office.
The office told KHN that the “participating provider” contract does not override the laws barring out-of-network charges in emergency situations. “Danielle had an emergency and Regence acknowledges it was an emergency, so she cannot be balance-billed,” said Stephanie Marquis, public affairs director for the Washington state Office of the Insurance Commissioner.
On Jan. 13, Regence said it would grant the Laskeys’ appeal to cover the first hospitalization as an in-network service, erasing the biggest part of Swedish’s bill but still leaving the family on the hook for the $15,000 bill for Danielle’s second visit and procedure.
On Jan. 27, two days after KHN contacted Regence and Swedish about Danielle Laskey’s case, a Regence representative called and informed her that her second hospitalization also would be reclassified as an in-network service.
Ashley Bach, a Regence spokesperson, confirmed to KHN that both stays now will be covered as emergency, in-network services, eliminating Swedish’s coinsurance charges. But in what appears to be contrary to the insurance commissioner’s stance, he said the bills had not violated state or federal laws prohibiting out-of-network charges in emergency situations because of the contract with Swedish covering all its plans.
“Under the Washington state and federal balance-billing laws, the definitions of whether a provider is considered in network hinges on whether there is a contract with a specific provider,” Bach said.
The Takeaway: More than a year after the federal surprise-billing law took effect, patients can still get hammered by surprise bills resulting from health plans’ limited provider networks and ambiguities about what is considered emergency medical care. The loopholes are out there, and patients like Laskey are just discovering them.
Washington state Rep. Marcus Riccelli, chair of the House Health Care and Wellness Committee, said he will ask the state’s public and private insurers what steps they could take to avoid provider network gaps and out-of-network billing surprises like this. He said he will also review whether there is a loophole in state law that needs to be closed by the legislature.
Fiedler said policymakers need to consider addressing what looks like a major gap in the new laws protecting consumers from surprise bills, since it’s possible that other insurers across the country have similar contracts with hospitals. “Potentially this is a significant loophole, and it’s not what lawmakers were aiming for,” he said.
Congress might have to fix the problem, since the federal agencies that administer the No Surprises Act may not have authority to do anything about it, he added.
Bruce Alexander, a CMS spokesperson, said the Departments of Health & Human Services, Labor, and Treasury are looking into this issue. While the agencies can’t predict whether a new rule or guidance will be needed to address it, he said, “they remain committed to protecting consumers from surprise medical bills.”
In the meantime, patients, even in emergencies, should ask their doctors before a hospital admission whether the hospital is in their plan network, out of network, or (watch for these words) a “participating provider.”
As the Laskeys discovered, hospital billing departments may offer little help in resolving surprise billing. So, while it is worth contesting questionable charges to the provider, it’s also usually an option to quickly appeal to your state insurance department or commissioner.
Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
Both Republicans and Democrats in Congress reacted with compassion to the news that Sen. John Fetterman (D-Pa.) has checked himself into Walter Reed National Military Medical Center for treatment of clinical depression. The reaction is a far cry from what it would have been 20 or even 10 years ago, as more politicians from both parties are willing to admit they are humans with human frailties.
Meanwhile, former South Carolina governor and GOP presidential candidate Nikki Haley is pushing “competency” tests for politicians over age 75. She has not specified, however, who would determine what the test should include and who would decide if politicians pass or fail.
This week’s panelists are Julie Rovner of KHN, Sarah Karlin-Smith of the Pink Sheet, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Rachel Roubein of The Washington Post.
Among the takeaways from this week’s episode:
Acknowledging a mental health disorder could spell doom for a politician’s career in the past, but rather than raising questions about his fitness to serve, Sen. John Fetterman’s decision to make his depression diagnosis and treatment public raises the possibility that personal experiences with the health system could make lawmakers better representatives.
In Medicare news, Sen. Rick Scott (R-Fla.) dropped Medicare and Social Security from his proposal to require that every federal program be specifically renewed every five years. Scott’s plan has been hammered by Democrats after President Joe Biden criticized it this month in his State of the Union address.
Medicare is not politically “untouchable,” though. Two Biden administration proposals seek to rein in the high cost of the popular Medicare Advantage program. Those are already proving controversial as well, particularly among Medicare beneficiaries who like the additional benefits that often come with the private-sector plans.
New studies on the effectiveness of ivermectin and mask use are drawing attention to pandemic preparedness. The study of ivermectin revealed that the drug is not effective against the covid-19 virus even in higher doses, raising the question about how far researchers must go to convince skeptics fed misinformation about using the drug to treat covid. Also, a new analysis of studies on mask use leaned on pre-pandemic studies, potentially undermining mask recommendations for future health crises.
On the abortion front, abortion rights supporters in Ohio are pushing for a ballot measure enshrining access to the procedure in its state constitution, while a lawyer in Florida is making an unusual “personhood” argument to advocate for a pregnant woman to be released from jail.
Plus for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Tras casi cinco décadas de intentos, la industria farmacéutica está a punto de suministrar vacunas eficaces contra el virus respiratorio sincitial (VRS), que ha llevado al hospital a 90,000 niños en lo que va del invierno.
Sin embargo, solo una de las vacunas está diseñada para administrarse a bebés, y un error en la redacción de la ley puede imposibilitar que los niños de bajos ingresos tengan el mismo acceso a la vacuna que los que tienen un buen seguro.
Desde 1994, la vacunación sistemática es un derecho de la infancia en el marco del programa Vacunas para los Niños, a través del cual el gobierno federal compra millones de vacunas y las suministra gratuitamente a través de pediatras y clínicas a los niños sin seguro, con seguro insuficiente o con Medicaid, que son más de la mitad de todos los menores estadounidenses.
La ley de 1993 por la que se creó el programa no incluye específicamente las inyecciones de anticuerpos, que se utilizaban raramente y solo como terapia de emergencia al momento en que se redactó el proyecto de ley.
Pero la primera inmunización que probablemente esté disponible para los bebés, llamada nirsevimab –se aprobó en Europa en diciembre y se prevé que la Administración de Drogas y Alimentos (FDA) la apruebe este verano–, no es una vacuna sino un anticuerpo monoclonal, que neutraliza los virus del VRS en el torrente sanguíneo.
La doctora Kelly Moore, presidenta del grupo de defensa Immunize.org, dijo que no hay duda que el Comité Asesor sobre Prácticas de Inmunización (ACIP) de Los Centros para el Control y la Prevención de Enfermedades (CDC) recomendará administrar el anticuerpo a los bebés. Ahora los CDC están analizando si nirsevimab sería elegible para el programa Vacunas para los Niños, dijo a KHN Kristen Nordlund, vocera de la agencia.
No hacerlo “condenaría a miles y miles de niños a hospitalizaciones y enfermedades graves por razones semánticas, a pesar de la existencia de una inmunización que funciona igual que una vacuna estacional”, afirmó.
Funcionarios de Sanofi, que está produciendo la inyección de nirsevimab junto con AstraZeneca, se negaron a indicar un precio, pero dijeron que el rango sería similar al de un curso de vacuna pediátrica. Los CDC pagan alrededor de $650 por la vacuna de rutina más costosa, las cuatro inyecciones contra la infección neumocócica. En otras palabras, la aprobación de la FDA convertiría al nirsevimab en un fármaco de gran éxito con un valor de miles de millones anuales si se administra a una gran parte de los aproximadamente 3,7 millones de niños que nacen en el país cada año.
Pfizer y GSK están fabricando vacunas tradicionales contra el VRS y esperan la aprobación de la FDA a finales de este año. La inyección de Pfizer inicialmente se administraría a las mujeres embarazadas, para proteger a sus bebés de la enfermedad, mientras que la de GSK sería para los adultos mayores.
Las vacunas para lactantes se encuentran en fase de desarrollo, pero expertos aún están un poco nerviosos al respecto. En 1966 fracasó estrepitosamente el ensayo de una vacuna contra este virus en el que murieron dos bebés, y los inmunólogos no se ponen totalmente de acuerdo sobre la causa del desastre, según el doctor Barney Graham, científico jubilado de VRS y covid.
Después que los aislamientos y las máscaras por covid ralentizaran su transmisión durante dos años, el VRS estalló este año en todo Estados Unidos, inundando las unidades de cuidados intensivos pediátricos.
Sanofi y AstraZeneca, los fabricantes de nirvisemab, esperan que la FDA lo apruebe, que los CDC lo recomienden y que se aplique en todo el país antes del otoño para prevenir nuevas epidemias del VRS.
Su producto está diseñado para administrarse antes de la primera temporada invernal del VRS de cada bebé. En los ensayos clínicos los anticuerpos ofrecieron una protección de hasta cinco meses; la mayoría de los menores no necesitarían una segunda dosis porque el virus no es un peligro mortal para los niños sanos de más de un año, dijo Jon Heinrichs, miembro principal de la división de vacunas de Sanofi.
Si no se acepta el tratamiento con anticuerpos para el programa Vacunas para Niños, habrá un acceso limitado a la vacuna para los que no tienen seguro médico y para los beneficiarios de Medicaid, la mayoría de los cuales son negros e hispanos (que pueden ser de cualquier raza), indicó Moore. Las farmacéuticas tendrían que negociar con el programa Medicaid de cada estado para incluirlo en sus formularios.
Excluir la vacuna del programa Vacunas para Niños “sólo empeoraría las disparidades sanitarias existentes”, dijo el doctor Sean O’Leary, profesor de pediatría de la Universidad de Colorado y presidente del comité de enfermedades infecciosas de la Academia Americana de Pediatría.
El VRS afecta a bebés de todas las clases sociales, pero tiende a perjudicar más a los hogares pobres y hacinados, dijo Graham. “Los antecedentes familiares de asma o alergia lo empeoran, y si son muy prematuros”, dijo.
Aunque entre el 2% y el 3% de los lactantes son hospitalizados cada año por el virus respiratorio sincitial, hay una alta supervivencia. Pero hasta 10,000 adultos mayores mueren cada año a causa de estas infecciones. Esto cambiará con el fin de pagos de bolsillo para todas las vacunas bajo Medicare, incluida la del VRS, bajo la Ley de Reducción de la Inflación de 2022.
Jennifer Reich, socióloga de la Universidad de Colorado que estudia las actitudes en materia de vacunación, afirmó que es probable que el alto grado de indecisión sobre las vacunas reduzca su aceptación, independientemente de quién las pague.
Los nuevos tipos de vacunas, como los anticuerpos de Sanofi/AstraZeneca, suelen asustar a los padres, y es probable que la vacuna de Pfizer para las mujeres embarazadas también provoque temor.
Los responsables de salud pública “no parecen saber cómo superar la desinformación” de que las vacunas merman la fertilidad o perjudican de algún otro modo a las personas, dijo Reich.
Por otra parte, la epidemia del VRS de este año será significativa para muchas madres, dijo Heidi Larson, líder del Vaccine Confidence Project y profesora de antropología en la Escuela de Higiene y Medicina Tropical de Londres.
“Tener a un hijo hospitalizado por el VRS da miedo”, afirmó.
Aunque desafortunado, “el elevado número de niños que murieron o ingresaron en la UCI en la última temporada con VRS es, en cierto modo, útil”, dijo la doctora Laura Riley, catedrática de obstetricia y ginecología de Weill Cornell Medicine en Nueva York.
Los especialistas de su campo no han empezado realmente a hablar de cómo informar a las mujeres sobre la vacuna, dijo Riley, presidenta del grupo de inmunización del Colegio Americano de Obstetras y Ginecólogos.
“Todo el mundo ha estado esperando a ver si se aprobaba”, señaló. “La educación tiene que empezar pronto, pero es difícil educar antes de lanzar la vacuna”.
A fund championed by Gov. Greg Gianforte to fill gaps in Montana’s substance use and behavioral health treatment programs has spent $5.2 million since last year as the state waits for an additional $19 million in federal funding.
Now, the Republican governor wants to put more state money into the Healing and Ending Addiction Through Recovery and Treatment initiative, but lawmakers and mental health advocates are asking for more accountability and clarity on how the money is spent.
Republican Rep. Jennifer Carlson, chair of the Human Services Committee of the Montana House of Representatives, said her committee has heard bill proposals seeking to use HEART money for child care and suicide prevention programs, among others. She is sponsoring a bill to increase HEART initiative reporting requirements.
“You really have to think, is that what that money is for, or is that just what’s convenient?” said Carlson.
Matt Kuntz, executive director of the Montana chapter of the National Alliance on Mental Illness, said a lot of questions have been floating around about the initiative this legislative session.
“Nobody really knows exactly how this is being spent or the process of how to get it,” Kuntz said.
The legislature passed Gianforte’s HEART initiative soon after he took office. It uses revenue primarily from recreational marijuana taxes for the state’s $6 million annual share to be distributed to programs dedicated to treating substance use and mental health disorders.
A federal match would bring the fund total to $25 million, but the state is waiting for full approval of its Medicaid waiver application from the Centers for Medicare & Medicaid Services. The federal agency approved part of the waiver last year.
“Until CMS approves the full HEART waiver, the state is limited in what we can do,” said Jon Ebelt, spokesperson for the state Department of Public Health and Human Services.
The health department submits a report to CMS four times a year. Department officials did not respond to a request by KHN for the latest report. The department is supposed to receive reports from tribal nations on how their funds were used. It didn’t specify whether it had received any.
Carlson’s House Bill 310 would require the department to report HEART initiative spending to the Children, Families, Health, and Human Services Interim Committee each year. That reporting would allow lawmakers to know what the money had already been used for, and if there might be a better way to spend it, Carlson said.
When Gianforte introduced the HEART initiative during his 2021 State of the State speech, he said it was designed to give directly to local communities, which know their own needs best.
“This is not bigger government,” the governor said at the time.
The HEART money is distributed through grants and Medicaid-funded services. Of the $5.2 million distributed since 2022, $1.5 million has gone to Medicaid for services like inpatient and residential chemical dependency services, Ebelt said.
Eight Indigenous tribal nations have received $1 million covering fiscal year 2022, the first year of the fund, and 2023, the current fiscal year, which ends June 30. Those grants went toward substance use prevention; mental health promotion; mental health crisis, treatment, and recovery services; and tobacco cessation and prevention.
Seven county detention centers received a total of $2.7 million in HEART money through a competitive grant process to provide behavioral health services at those facilities.
Missoula County hired a therapist, jail care coordinator, and mental health transport officer with its share. Gallatin County hired a counselor and two social workers, and Lewis and Clark County hired a therapist, case manager, and education and transport manager.
Jackie Kerry Lemon, program and facilities director at the Gallatin County Detention Center, said the money had to be used for mental health and addiction services. “Our population is often in crisis when they come to us, so having that ability to have a therapist see them really does help with their anxiety and their needs at a good time,” Kerry Lemon said.
Democratic Rep. Mary Caferro said the HEART money could go toward increases in the Medicaid rates paid to health care providers, which a state study found fall short of the cost of care, or mobile crisis response teams, which the health department intends to provide as a Medicaid service.
Caferro is sponsoring a bill on behalf of the National Alliance on Mental Illness to add youth suicide prevention to the list of programs eligible for HEART funding.
Mary Windecker, executive director of the Behavioral Health Alliance of Montana, said the HEART fund initially was meant to support tribes and county jails, and only recently did it start funding community substance use and mental health programs, after last year’s partial Medicaid waiver approval.
That allowed larger substance use disorder treatment centers (more than 17 beds) to receive Medicaid reimbursement for short-term stays at institutions for mental illness, like Rimrock in Billings and the Badlands Treatment Center in Glendive.
From July 2022 to January 2023, Ebelt said, 276 Medicaid recipients were treated in Rimrock and Badlands. A facility in Clinton, the Recovery Centers of Montana, opened in December and will be licensed for 55 additional beds able to serve patients with the new Medicaid benefit, Ebelt said. Gianforte proposed in his state budget to increase the amount going into the HEART fund by changing the funding formula from $6 million a year to 11% of Montana’s annual recreational marijuana tax revenue.
The Behavioral Health Alliance recommended that change, but, as with many of the health-related proposals in this legislative session, a major factor in the HEART initiative’s success will be whether Medicaid provider rates are raised enough, Windecker said. If provider rates aren’t funded at the full cost of care, people won’t be available to provide the care the initiative promises, she said.
The committee that meets to determine the health department’s budget will hear a presentation about the HEART initiative on Feb. 9.
Keely Larson is the KHN fellow for the UM Legislative News Service, a partnership of the University of Montana School of Journalism, the Montana Newspaper Association, and Kaiser Health News. Larson is a graduate student in environmental and natural resources journalism at the University of Montana.
Anti-abortion advocates are pressing for expanded abortion bans and tighter restrictions since the Supreme Court overturned the national right to abortion. But with the debate mostly deadlocked in Washington, the focus is shifting to states convening their first full legislative sessions since Roe v. Wade was overturned.
Although some state GOP lawmakers have filed bills to ban abortion pills or make it more difficult for women to travel out of state for an abortion, others seem split about what their next steps should be. Some are even considering measures to ease their states’ existing bans somewhat, particularly after Republicans’ less-than-stellar showing in the 2022 midterm elections and voters’ widespread support for abortion on state ballot measures.
Meanwhile, Democratic-led states are looking to shore up abortion protections, including Minnesota and Michigan, where Democrats sewed up legislative majorities in the November elections.
Anti-abortion groups said their goal in overturning Roe v. Wade was to turn the decision back to the states, but now they are making clear that what they want is an encompassing national abortion ban.
“Legislation at the state and federal levels should provide the most generous protections possible to life in the womb,” says the “Post-Roe Blueprint” of the anti-abortion group Students for Life.
The new Republican-led House showed its anti-abortion bona fides on its first day of formal legislating, Jan. 11, passing two pieces of anti-abortion legislation that are unlikely to become law with a Senate still controlled by Democrats and President Joe Biden in the White House.
So at the federal level, the fight is taking shape in the courts over the abortion pill mifepristone, which has been used as part of a two-drug regimen for more than two decades, and recently became the way a majority of abortions in the U.S. are conducted.
The Biden administration has moved to make mifepristone more widely available by allowing it to be distributed by pharmacies, as well as clarifying that it is legal to distribute the pills via the U.S. mail. But the conservative legal group Alliance Defending Freedom, on behalf of several anti-abortion groups, filed a federal lawsuit in Texas in November, charging that the FDA never had the authority to approve the drug in the first place.
In Texas, some lawmakers are exploring new ways to chip away at Texans’ remaining sliver of access to abortions. For example, one proposal would prevent local governments from using tax dollars to help people access abortion services out of state, while another would prohibit tax subsidies for businesses that help their local employees obtain abortions out of state.
Those measures could get lost in the shuffle of the state’s frantic 140-day, every-other-year session, if legislative leaders don’t consider them a priority. The state’s trigger law banning almost all abortions that went into effect last year “appears to be working very well,” said Joe Pojman, founder and executive director of Texas Alliance for Life, an anti-abortion group. In August 2022, three abortions were documented in the state, down from more 5,700 reported during the same month a year earlier, according to the most recent state data.
The top state House Republican said his priority is boosting support for new moms, for example, by extending postpartum Medicaid coverage to 12 months.
It’s “an opportunity for the Texas House to focus more than ever on supporting mothers and children,” said Republican House Speaker Dade Phelan.
South Dakota Gov. Kristi Noem, a Republican, struck a similar theme in a Jan. 10 speech, saying she will introduce bills to expand a program for nurses to visit new mothers at home and help state employees pay for adoptions. Previously, Noem said South Dakota needs to focus “on taking care of mothers in crisis and getting them the resources that they need for both them and their child to be successful.”
Some Texas GOP lawmakers indicated they may be open to carving out exceptions to the abortion ban in cases of rape and incest. And a Republican lawmaker plans to attempt to modify South Dakota’s ban, which allows abortions only for life-threatening pregnancies, to clarify when abortions are medically necessary.
“Part of the issue right now is that doctors and providers just don’t know what that line is,” said state Rep. Taylor Rehfeldt, a nurse who has experienced miscarriages and high-risk pregnancies herself.
Rehfeldt wants to reinstate a former law that allows abortions for pregnancies that could cause serious, irreversible physical harm to a “major bodily function.” Rehfeldt said she is also working on bills to allow abortions for people carrying non-viable fetuses, or who became pregnant after rape or incest.
Some anti-abortion activists in Georgia are pushing lawmakers to go further than the state’s ban on most abortions at about six weeks of pregnancy. They want a law to ban telehealth prescriptions of abortion pills and a state constitutional amendment declaring that an embryo or a fetus has all the legal rights of a person at any stage of development.
“Roe is out of the way,” said Zemmie Fleck, executive director of Georgia Right to Life. “There’s no more roadblock to what we can do in our state.”
Republican leaders, however, are biding their time while Georgia’s high court weighs a legal challenge of the six-week ban. “Our focus remains on the case before the Georgia Supreme Court and seeing it across the finish line,” said Andrew Isenhour, spokesperson for Republican Gov. Brian Kemp.
Abortion rights lawmakers and advocates have few options to advance their initiatives in these Republican-controlled statehouses.
A Georgia Democrat filed a bill that would make the state compensate women who are unable to terminate pregnancies because of the state’s abortion ban. State Rep. Dar’shun Kendrick acknowledged her bill likely won’t go far, but she said she hopes it keeps attention on the issue and forces GOP lawmakers to “put their money where their mouth is” in supporting families.
In Missouri, where nearly all abortions are now banned, abortion rights advocates are mulling the idea of circumventing the state’s Republican-dominated legislature by asking voters in 2024 to enshrine the right to an abortion in the state’s constitution.
But those efforts could be upended by a slew of bills filed by Republican lawmakers seeking to make it more difficult to place constitutional initiatives on the ballot, and for those measures that do make it on the ballot, by requiring the approval of at least 60% of voters for passage.
Democrats in Michigan and Minnesota are likely to use their newfound control of both legislative chambers and the governors’ office to protect abortion access. While Michigan voters already passed a ballot measure in November that enshrines the right to abortions in the state constitution, Democrats are trying to repeal a 1931 abortion law from the books.
The November elections brought divided government to Arizona and Nevada, with Arizona now having a Democratic governor and Nevada having a Republican one. Any abortion-related bills that pass the legislatures in those states could be vetoed.
Some Republican-controlled legislatures, including those in Montana, Florida, and Alaska, also are limited in passing sweeping abortion bans because of court rulings that tie abortion access to right-to-privacy provisions in those states’ constitutions.
In Montana, a state judge blocked three anti-abortion laws passed in 2021 on that basis. State government attorneys have asked the Montana Supreme Court to reverse the precedent, and a decision is pending.
In the meantime, Republican state Sen. Keith Regier has filed a bill there seeking to exclude abortion from the state’s definition of a right to privacy. Regier said he believes an individual’s right to privacy should not apply to abortion because an unborn child also is involved.
Democratic leaders said Republicans are out of sync with the people they represent on this issue. In November, Montana voters rejected a “born alive” ballot initiative that would have required doctors to apply medical care to newborns who draw breath or have a heartbeat after a failed abortion or any other birth.
“Montanans said so clearly that they do not want government overreach in their health care decisions,” said Democratic state Rep. Alice Buckley.
KHN correspondents Renuka Rayasam and Sam Whitehead in Atlanta; Arielle Zionts in Rapid City, South Dakota; Bram Sable-Smith in St. Louis; and Katheryn Houghton in Missoula, Montana, contributed to this report.
ELKO, Nev. — When Ruby B. Sutton found out she was pregnant in late 2021, it was hard to envision how her full-time job would fit with having a newborn at home. She faced a three-hour round-trip commute to the mine site where she worked as an environmental engineer, 12-plus-hour workdays, expensive child care, and her desire to be present with her newborn.
Sutton, 32, said the minimal paid maternity leave that her employer offered didn’t seem like enough time for her body to heal from giving birth or to bond with her firstborn. Those concerns were magnified when she needed an emergency cesarean section.
“I’m a very career-driven person,” Sutton said. “It was really difficult to make that decision.”
Sutton quit her job because she felt even additional unpaid time off wouldn’t be enough. She also knew child care following maternity leave would cost a substantial portion of her salary if she returned to work.
Tens of millions of American workers face similar decisions when they need to care for themselves, a family member, or a baby. Wild variations in paid leave regulations from state to state and locally mean those choices are further complicated by financial factors. And workers in rural areas face even more challenges than those in cities, including greater distances to hospitals and fewer medical providers, exacerbating health and income disparities. Companies in rural areas may be less likely to voluntarily offer the benefit because they tend to be smaller and there are fewer employers for workers to choose from.
While a growing number of states, cities, and counties have passed paid sick leave or general paid time off laws in recent years, most states where more than 20% of the population is rural haven’t, leaving workers vulnerable. Vermont and New Mexico are the only states with a sizable rural population that have passed laws requiring some form of paid sick leave.
Experts say the gaps in paid leave requirements mean workers in rural areas often struggle to care for themselves or loved ones while making ends meet.
“The problem is, because it’s a small percentage of the population, it’s often forgotten,” said Anne Lofaso, a professor of law at West Virginia University.
The covid-19 pandemic steered attention toward paid leave policies as millions of people contracted the virus and needed to quarantine for five to 10 days to avoid infecting co-workers. The 2020 Families First Coronavirus Response Act temporarily required employers with fewer than 500 employees and all public employers to give workers a minimum of two weeks of paid sick leave, but that requirement expired at the end of 2020.
The expiration left workers to rely on the Family and Medical Leave Act of 1993, which requires companies with 50 or more employees to provide them with up to 12 weeks of unpaid time off to care for themselves or family members. But many workers can’t afford to go that long without pay.
By March 2022, 77% of workers at private companies had paid sick leave through their employers, according to the Bureau of Labor Statistics — a small increase from 2019, when 73% of workers in private industry had it. But workers in certain industries — like construction, farming, forestry, and extraction — part-time workers, and lower-wage earners are less likely to have paid sick leave.
“Paid leave is presented as a high-cost item,” said Kate Bronfenbrenner, director of labor education research at the School of Industrial and Labor Relations at Cornell University.
But it comes with a payoff: Without it, people who feel pressure to go to work let health conditions fester and deteriorate. And, of course, infectious workers who return too early unnecessarily expose others in the workplace.
Advocates say a stronger federal policy guaranteeing and protecting paid sick and family leave would mean workers wouldn’t have to choose between pushing through illness at work or losing income or jobs.
A recent report by New America, a left-leaning think tank, argues that creating policy to ensure paid leave could boost employment numbers; reduce economic, gender, and racial disparities; and generally lift up local communities.
Support for paid sick and family leave is popular among rural Americans, according to the National Partnership for Women & Families, which found in 2020 polling that 80% of rural voters supported a permanent paid family and medical leave program, allowing people to take time off from work to care for children or other family members.
But lawmakers have been divided on creating a national policy, with opponents worrying that requiring paid leave would be too big a financial burden for small or struggling businesses.
In 2006, voters in San Francisco approved the Paid Sick Leave Ordinance, making it the first U.S. city to mandate paid sick leave. Since then, 14 states, the District of Columbia, and 20 other cities or counties have done so. Two other states, Nevada and Maine, have adopted general paid time off laws that provide time that can be used for illness.
Federal workers are offered 12 weeks of paid parental leave in the Federal Employee Paid Leave Act, adopted in October 2020. It covers more than 2 million civilian workers employed by the U.S. government, though the law must be reapproved each fiscal year and employees are not eligible until they’ve completed one year of service.
The patchwork of laws nationwide leaves workers in several mostly rural states — places like Montana, South Dakota, and West Virginia where more than 40% of residents live outside cities — without mandated paid sick and family leave.
Sutton said she “would have definitely loved” to stay at her job if she could’ve taken a longer paid maternity leave. She said she wants to return to work, but the future is unclear. She has more things to consider, like whether she and her husband want more children and when she might feel healthy enough to try for a second baby after last summer’s C-section.
Sutton recalled a friend she worked with at a gold mine years ago who left the job a few months after having a baby. “And I understand now all the things she was telling me at that time. … She was like, ‘I can’t do this,’ you know?”
