Tagged Women’s Health

High Court Allows Employers To Opt Out Of ACA’s Mandate On Birth Control Coverage

The Supreme Court Wednesday settled — at least for now — a decade’s worth of litigation over the women’s health provisions of the Affordable Care Act, ruling 7-2 that employers with a “religious or moral objection” to providing contraceptive coverage to their employees may opt out without penalty.

The Trump administration was within its rights to exempt religious nonprofit agencies, like the lead plaintiff in the case – the Catholic order Little Sisters of the Poor – from having to participate in any way from facilitating contraceptive coverage for their employees. Wrote Justice Clarence Thomas in the majority opinion, “We hold today that the Departments had the statutory authority to craft that exemption, as well as the contemporaneously issued moral exemption

Women’s health groups were quick to decry the ruling – even though liberal Justices Stephen Breyer and Elena Kagan agreed with the outcome.

“The Supreme Court just ruled that your boss or your university can, based on their own objections, take away your birth control coverage,” tweeted Planned Parenthood Action Fund, the political arm of Planned Parenthood. “The fact that the Court allowed this attack birth control coverage under the ACA in 2020 — and which has benefitted over 62 million people — shows the war on our reproductive health care isn’t just about access to abortion. It’s everything.

The ACA itself did not require that contraceptives be covered. Rather, it called for preventive health services for women to be included in most insurance plans and left it to the Department of Health and Human Services to figure out which ones. In the Obama administration, HHS asked the Institute of Medicine (now the National Academy of Medicine) to recommend which services had enough scientific evidence backing them to be added, and FDA-approved methods of contraception were named by the institute.

That spurred bitter controversy, with some religious groups and business owners who object to certain types of contraceptives arguing that they should not be forced to provide the services to workers.

The Supreme Court ruled in 2014 that “closely held corporations” like the craft chain Hobby Lobby did not have to abide by the contraceptive coverage requirement. But that did not settle the issue completely.

From the start, the Obama administration exempted churches and other religious entities from the coverage requirement. Still, there was an outcry for relief from religious nonprofit groups such as hospitals and universities. And that battle has raged since Obama officials tried to find compromise after compromise, to no avail.

The last Obama rule allowed religious nonprofits to opt out of providing coverage directly by signing a form that would transfer the financial and administrative responsibility for coverage to their health insurer. But the organizations — including the Little Sisters of the Poor, which operates long-term care homes for low-income seniors — insist that the act of signing the form facilitates the coverage and makes them “complicit in sin.”

The Supreme Court took up the case — actually seven cases bundled together — in 2016. But with only eight justices on the bench following the death of Justice Antonin Scalia earlier that year, the court deadlocked 4-4 and sent the cases back to the lower courts, with orders to try to find a compromise that would allow employees to receive coverage without compromising the religious beliefs of the employers.

With the election of Donald Trump, the controversy continued, but in reverse. The Trump administration issued rules to give organizations with not just religious, but also moral, objections to birth control the ability to opt out. And it was sued by those who believe women should have the right to no-cost contraception, including state governments, whose leaders fear that if employers opt out, the states will end up paying more for state contraceptive programs and costs associated with unwanted pregnancies.

The addition of moral objection is a dramatic expansion, said Michael Fisher, who argued the case on behalf of Pennsylvania during the court’s oral arguments in May. Fisher said the provision was so broad that employers could deny contraceptive coverage because they morally object to women being in the workplace.

The decision is likely to have a political impact larger than its actual consequence – the loss of no-cost birth control for perhaps hundreds of thousands of women. While the court will not decide its broader case challenging the constitutionality of the Affordable Care Act before November’s election, it could boost the law’s fate back onto the electoral front burner.

Related Topics

Courts Public Health The Health Law

Pruebas para el VPH y el cáncer cervical podrían hacerse en casa

Pasa un pequeño hisopo por la vagina para recoger células. Luego lo colocas en un kit de detección y lo envías por correo.

Una prueba sencilla como ésta, que se puede hacer en casa, ayudaría a los Estados Unidos a acercarse a la erradicación del cáncer de cuello uterino o cáncer cervical.

El año que viene, el Instituto Nacional del Cáncer (NCI) lanzará un estudio en diferentes localidades que involucrará a unas 5,000 mujeres para evaluar si la autoprueba casera puede equivaler a la que realiza el médico en un consultorio.

Casi 14,000 estadounidenses este año serán diagnosticadas con un cáncer que es prevenible, y más de 4,000 morirán. Las mujeres que no tienen seguro o que no pueden acceder a servicios médicos regulares tienen más probabilidades de no hacerse pruebas de detección que salvan vidas, dijo Vikrant Sahasrabuddhe, de la División de Prevención del Cáncer del NCI.

Sin salir de sus casas, las mujeres podrían recolectar células vaginales y cervicales para analizarlas en la detección del virus del papiloma humano (VPH), que causa virtualmente todos los cánceres cervicales, de la misma manera que las muestras de heces en casa pueden usarse para detectar el cáncer de colon, añadió.

“Sigue existiendo un número constante de mujeres que padece cáncer cervical cada año”, explicó Sahasrabuddhe, que supervisa los estudios sobre los cánceres relacionados con el VPH. “Y ese número no va a bajar”.

Las autoridades federales esperan que la investigación acelere un test aprobado por la Administración de Alimentos y Medicamentos (FDA) que podría formar parte de las directrices de evaluación si se demuestra que tomar la muestra en casa es eficaz, señaló Sahasrabuddhe.

En lugar de esperar a que las empresas que realizan las pruebas de VPH para los médicos hagan estudios de automuestreo, los funcionarios federales se unirán a empresas, instituciones académicas y otros en una asociación público-privada, explicó. Los funcionarios del NCI, que esperan gastar unos $6 millones en fondos federales, supervisarán los datos y el análisis del estudio.

“Queremos acelerar ese proceso”, indicó Sahasrabuddhe.

El automuestreo del VPH, existente en países como Australia y los Países Bajos, es uno de los enfoques de los investigadores del cáncer cervical en los Estados Unidos. Otra estrategia clave consiste en vacunar a las adolescentes contra el VPH, que se transmite a través de la actividad sexual. En 2018, casi el 54% de las niñas habían sido vacunadas al llegar a los 17 años, al igual que casi el 49% de los niños, según los datos federales más recientes.

Los países que han tenido más éxito en la reducción del cáncer cervical —un análisis predice que Australia está en vías de eliminar la enfermedad— han hecho hincapié en la vacunación contra el VPH en adolescentes.

Las autoridades siguen aconsejando a las mujeres vacunadas que se sometan regularmente a pruebas de detección, ya que la vacuna no protege contra todas las cepas que causan el cáncer de cuello uterino.

Sin embargo, a veces es un desafío.

Para algunas, el acceso o el costo puede ser un problema. La mayoría de los planes médicos cubren los exámenes y también hay algunos programas públicos, pero las mujeres sin seguro que no los conocen tienen que pagar por la consulta y la prueba.

Además, las mujeres no siempre salir del trabajo o encontrar una guardería, o pueden haber tenido “emociones o experiencias negativas en el pasado con los exámenes pélvicos”, señaló Rachel Winer, profesora de epidemiología de la Escuela de Salud Pública de la Universidad de Washington que estudia el automuestreo del VPH.

Invertir la tendencia

Unas 4 de cada 5 mujeres se someten regularmente a pruebas de detección de cáncer cervical, pero los índices alcanzaron su punto máximo alrededor del año 2000 y han disminuido ligeramente desde entonces, según datos federales.

Otro análisis de registros médicos de 27,418 mujeres de Minnesota, de entre 30 y 65 años, encontró que casi el 65% se había hecho la prueba en 2016, según publicó el año pasado el Journal of Women’s Health.

“Lamentablemente, creo que nuestros datos probablemente reflejan mejor lo que está sucediendo con los índices de evaluación en nuestro país”, expresó la doctora Kathy MacLaughlin, autora del estudio e investigadora de la Clínica Mayo en Rochester, Minnesota.

Un obstáculo para la prueba podría ser la complejidad de las directrices, dijo MacLaughlin. En lugar de un examen anual fácil de recordar, las evaluaciones ocurren en intervalos de más de un año. La edad de la mujer ayuda a determinar cuándo se recomienda la prueba de VPH o la citología vaginal (el Papanicolau), que recoge células del cuello uterino para buscar cambios precancerosos.

“El reto es cómo recordar que debemos hacer algo cada tres o cada cinco años”, comentó MacLaughlin.

Logística en casa

Si bien el NCI aún no ha decidido el tipo de automuestreo que utilizará, la técnica generalmente requiere que la mujer inserte un pequeño hisopo en su vagina y lo rote varias veces para recolectar las células.

Luego desliza el hisopo en un contenedor de muestras que tiene una solución conservante y devuelve el kit para el análisis del VPH.

Según un informe publicado en 2018 en la revista médica BMJ, la precisión de la identificación del VPH era similar cuando las muestras eran recogidas por las mujeres en casa que cuando lo hacía un médico.

También se estudia una prueba de VPH en orina, que podría resultar más fácil de realizar para las mujeres, dijo Jennifer Smith, profesora de epidemiología de la Escuela Gillings de Salud Pública Global de la Universidad de Carolina del Norte.

Antes que las compañías puedan aplicar para pruebas caseras aprobadas por la FDA, el automuestreo de las mujeres debe ser comparable en la detección del VPH, aunque no sea tan preciso, como cuando lo hace un médico, señaló Sahasrabuddhe.

Los funcionarios del NCI aún están ultimando los detalles del estudio. Pero el plan es invitar a participar a cuatro compañías que ya fabrican pruebas de VPH para médicos, dijo Sahasrabuddhe.

Las empresas pagarán el costo de las pruebas y las futuras tarifas relacionadas con la solicitud de licencias a través de la FDA. Sahasrabuddhe espera que los resultados del estudio estén disponibles para 2024, si no antes.

Si una mujer da positivo en las pruebas de VPH podría necesitar una biopsia, para buscar células anormales o cáncer cervical, indicó Sahasrabuddhe.

Si se desarrolla un test casero aprobado por la FDA, es crucial que las mujeres sin seguro y otras que no tienen acceso fácil a la atención médica puedan conseguirlo, enfatizó Smith.

“Porque no se envían kits al azar a los hogares”, dijo Smith, “y nadie se asegura que tengan a alguien con quien hablar sobre los resultados y que puedan tener un seguimiento”.

Related Topics

Insurance Noticias En Español Uninsured

NIH Spearheads Study To Test At-Home Screening For HPV And Cervical Cancer

With a tiny brush, briefly swab the vagina to collect cells. Then slide the swab into a screening kit and drop it into the mail.

Proponents believe a simple test like this, which can be done at home, may help the U.S. move closer to eradicating cervical cancer. The National Cancer Institute plans to launch a multisite study next year involving roughly 5,000 women to assess whether self-sampling at home is comparable to screening in the office by a clinician.

Nearly 14,000 Americans this year will be diagnosed with the highly preventable cancer, and more than 4,000 will die. Women who are uninsured or can’t get regular medical care are more likely to miss out on lifesaving screening, said Vikrant Sahasrabuddhe, a program director in the NCI’s Division of Cancer Prevention. If women could collect the vaginal and cervical cells to be tested for human papillomavirus (HPV) — the virus that causes virtually all cervical cancers — they could get screened from home, just as home-based stool samples can be used to detect colon cancer, he said.

“What we have seen is this persistent group of women who continue to get cervical cancer every year,” said Sahasrabuddhe, who oversees studies involving HPV-related cancers. “And that number is really not going down.”

Federal officials hope the research will fast-track a test approved by the Food and Drug Administration that could be part of screening guidelines if self-sampling is proved effective, Sahasrabuddhe said. Rather than wait for self-sampling studies to be done by the individual companies that make the HPV tests for clinicians, federal officials will team up with the companies, academic institutions and others in a public-private partnership, he explained. NCI officials, who expect to spend about $6 million in federal funds, will oversee the study’s data and analysis.

“If every company goes and does their own trial, they may take years to achieve it,” Sahasrabuddhe said. “We want to accelerate that process.”

HPV self-sampling, already promoted in countries such as Australia and the Netherlands, is one of several approaches that U.S. cervical cancer researchers are pursuing. Another key strategy involves vaccinating adolescents against HPV, which is transmitted through sexual activity. As of 2018, nearly 54% of girls had been fully vaccinated by age 17, as had almost 49% of boys, according to the most recent federal data. The countries that have had better success in reducing cervical cancer — one analysis predicts that Australia is on track to eliminate the disease — have emphasized HPV vaccination for adolescents.

Federal officials still advise vaccinated women to get regularly screened, as the vaccine doesn’t guard against all the strains that cause cervical cancer. But persuading some women to come into the office for the physical exam is sometimes a tough sell.

For some, access or cost may be an issue. Most insurance plans cover screening and there are also some public programs, but uninsured women who are unaware of them may have to pay for an office visit and test. Besides, women can’t always break away from work or find child care, or they may have had “negative emotions or experiences in the past with pelvic exams,” said Rachel Winer, a professor of epidemiology at the University of Washington School of Public Health who studies HPV self-sampling.

Reversing The Trend

Roughly 4 out of 5 women get regularly screened for cervical cancer, but the rates peaked around 2000 and have been on a slight decline since, according to federal data. That figure, which is based on patient self-reporting, may be optimistic. Another analysis, which looked at the medical records of 27,418 Minnesota women ages 30 to 65, found that nearly 65% were up to date as of 2016, according to the findings, published last year in the Journal of Women’s Health.

“Sadly, I think our data is probably more reflective of what’s happening with screening rates in our country,” said Dr. Kathy MacLaughlin, a study author and researcher at Mayo Clinic in Rochester, Minnesota.

One hurdle to getting screened may be the complexity of the guidelines, MacLaughlin said. Rather than an easy-to-remember annual exam, screenings occur at intervals of longer than a year. A woman’s age helps determine when the HPV test or a Pap smear, which collects cells from the cervix to look for precancerous changes, is recommended by the U.S. Preventive Services Task Force.

“It’s just that challenge of, how do any of us remember to do something every three years or every five years?” MacLaughlin said. “That’s hard.”

At-Home Logistics

While the NCI hasn’t yet settled on the precise self-sampling approach it will use, the technique generally requires the woman to insert a tiny brush into her vagina and rotate it several times to collect the cells. Then she slides the brush into a specimen container that has a preservative solution and returns the kit for HPV analysis.

According to a review of studies published in 2018 in the medical journal BMJ, the accuracy of identifying HPV was similar when the samples were collected by women at home as when collected by clinicians. A urine-based HPV test, which may prove easier for women to perform, also is being studied, said Jennifer Smith, a professor of epidemiology at the University of North Carolina’s Gillings School of Global Public Health.

Before companies can pursue applications for an FDA-approved home test, self-sampling by women has to be shown comparable to detect HPV, though perhaps it may not be quite as accurate as when a clinician is involved, Sahasrabuddhe said. NCI officials are still finalizing study details. But the plan is to invite four companies that already manufacture HPV tests for clinicians to participate, Sahasrabuddhe said. The companies will pick up the tab for the cost of the tests as well as future fees related to pursuing license applications through the FDA, he said. Sahasrabuddhe expects the study results to be available by 2024, if not sooner.

Any woman who tests positive for HPV will be referred for procedures, including possibly a biopsy, to look for abnormal cells or cervical cancer, Sahasrabuddhe said.

If an FDA-approved home test is developed, it’s crucial that uninsured women and others who don’t have easy access to medical care be able to get those procedures, Smith said.

“You just don’t send random kits out to people’s homes,” Smith said, “and not ensure that they have someone to talk to about the results and are going to be able to be integrated into a follow-up system.”

Related Topics

Insurance Uninsured