Key court decisions in 2024 about prescription drug prices, abortion bans, gender-affirming care and the Affordable Care Act could change the way health care is delivered in America.
Health care policy experts are keeping close tabs on the courts in 2024. Judges are poised to weigh in on health policies — new ones, like Medicare’s power to negotiate drug prices, and old ones, like the Affordable Care Act’s insurance rules.
The ramifications of these decisions, some on politically charged issues such as abortion bans and gender-affirming care, are especially important during an election year.
Here are five legal battles experts will be watching closely in the coming months:
1. High Court Could Sharply Limit Medical Abortions
The Supreme Court of the United States will hear oral arguments in March in a case involving the Alliance for Hippocratic Medicine, a group of anti-abortion physicians who are challenging the availability of a drug routinely used in medical abortions. This will be the first abortion-related case the justices will hear since SCOTUS voted to overturn the constitutional right to abortion in 2022.
The court will consider whether a group of physicians has the legal standing to challenge the FDA approvals of mifepristone, one of two drugs used to end a pregnancy. Although mifepristone has been FDA-approved and prescribed in clinics and doctors’ offices for more than two decades, the regulatory agency has increased access dating back to 2016. Currently federal rules allow to women get their prescriptions via telehealth appointments and can take the pills at home anytime in the first 10 weeks of pregnancy.
Medication abortions now account for more than half of abortions nationwide. With nearly 50% of states now restricting access to surgical abortions, experts expect even more women will turn to mifepristone; they say that’s why the drug has come under heightened scrutiny by anti-abortion groups.
The Alliance of Hippocratic Medicine filed its lawsuit in 2022, arguing that since its members may have to treat medication side effects, they should be able to challenge the drug’s use and approval. The FDA and major medical associations including the American College of Obstetricians and Gynecologists and the American Medical Association counter that Alliance members don’t have to prescribe the drug, and point out that decades of research and real world evidence have shown mifepristone to be safe and effective. Of the nearly 6 million women who have taken the medication in the U.S., less than 1% have reported complications.
A federal district court judge in Texas agreed with the Alliance in 2023 (though any changes to mifepristone access are on hold until the case is resolved by SCOTUS). The trial court ruling marked the first time an FDA stamp of approval was overturned because a judge disagreed with the agency’s scientific judgment.
The case is drawing interest from physicians, patient advocates, drugmakers and state lawmakers who worry this challenge to the FDA’s authority could undo FDA decisions on other drugs. Laurie Sobel, an associate director for women’s health policy at KFF, said medications disfavored by the religious right — like PrEP, a preventive treatment that counters HIV infection — could be targeted. “It’s definitely in the crosshairs of cultural wars, much in the way that medication abortion is,” Sobel said. “But it’s highly effective, and it’s been a game changer in terms of changing the spread of HIV.”
2. State Abortion Restrictions Get New Scrutiny
In April, the Supreme Court is scheduled to hear a second abortion case — that tests whether state bans on abortion must include exceptions, and if so, which ones.
In 2022, the Justice Department sued Idaho claiming its restrictive abortion ban violated a longstanding federal law requiring hospitals to stabilize patients in medical emergencies.
Today 14 states have total bans and 11 others block the procedure at certain points in pregnancy. The Idaho law, for example, permits abortion only to save the life of the pregnant person, or in other very narrow instances. Doctors who violate Idaho’s law can lose their state medical license and/or face prison.
Meanwhile, the federal government threatens that if Idaho doctors (or health providers in any state) fail to perform an abortion when a mother’s health is at risk, doctors and hospitals could be fined or lose federal reimbursement for other medical services. The Centers for Medicare and Medicaid Services is investigating complaints, and has already found facilities in Kansas and Missouri violated the law when they denied emergency abortion services to a woman who was at risk of serious infection and losing her life when her water broke at 18 weeks of pregnancy.
This conflict between federal and state law prevents doctors from relying on their own medical judgment, said KFF’s Laurie Sobel. “Doctors are consulting lawyers for the hospital to say, OK, can I do it now?… Can I do it now?”
Sobel said states with very narrow exceptions are forcing doctors to ask themselves “how close to death do you need to be to get an abortion?”
A SCOTUS decision in the Idaho case, expected this summer, could define “health exceptions” to abortion bans across the country. Or the court could decide to allow some states to continue with only “life of the mother” exceptions.
3. Religious Right Takes Aim at the Affordable Care Act
Since the Affordable Care Act’s inception in 2010, more than 2,000 court cases have tried — to challenge parts of the law. The latest attempt, Braidwood Management v Becerra, is now before the Fifth Circuit Court of Appeals in New Orleans, and expected to wind its way to the U.S. Supreme Court.
In this case, a Christian-owned business and six other plaintiffs are challenging one of the most popular provisions of the ACA — a stipulation that nearly all insurers must offer members certain preventive care for free, including contraception and the anti-HIV treatment known as PrEP, as well as certain vaccines and cancer screenings.
The plaintiffs complain that the federal requirement forces them to pay for some medical products and services that violate their religious beliefs about sexuality. The case was decided in their favor in 2023, but any changes to the law based on that decision are on hold while the appeal proceeds.
Zach Baron, co-director of the Health Policy and the Law Initiative at O’Neill Institute at Georgetown Law School, warns that if Braidwood wins that would return the country to pre-ACA days.
“They want to make it so that insurers and employers can pick and choose which of these benefits to cover and how much to charge for them,” said Baron.
Legal experts expect this case to wind up at the Supreme Court — the fourth ACA case SCOTUS will hear.
4. Parents Sue Over State Bans on Gender-Affirming Care for Teens
At least 23 states have passed laws in recent years that limit or ban gender-affirming care for minors. UCLA’s Williams Institute, a public policy organization focused on LGBTQ issues, estimates such bans affect about 100,000 transgender teens.
Many parents and major medical associations, including the American Academy of Pediatrics and the American Medical Association, say research supports the idea that gender-affirming surgery and medication can be beneficial for the mental health of trans young people.
Families challenging state bans in courts argue the laws are a form of sex discrimination, and target transgender people.
Federal judges in multiple states — including Arkansas and Idaho — agree, noting these same states allow doctors to prescribe the same hormones to other teens for different medical reasons, including birth defects and certain medical conditions that affect the ovaries.
But appellate courts governing Alabama, Kentucky and Tennessee ruled that the prohibitions against gender-affirming care in those states aren’t discriminatory based on sex, because the laws ban care for males and females alike.
The families in Tennessee, Kentucky and the U.S. Justice Department have asked the Supreme Court to take up their case challenging Tennessee’s ban. If the court sides with such bans, says Katie Eyer, a Rutgers University expert in anti-discrimination law, it could undermine other civil rights protections for transgender people.
“I think it is very clear that we are at a moment where the courts are very much involved in deciding the constitutional rights of the transgender community,” Eyer said, adding that any decisions in this case, “would be clearly significant to all of the other discriminatory laws that have recently been enacted targeting transgender people.”
5. Big Pharma Challenges Medicare’s New Drug Negotiation Powers
Medicare is expected to kick off negotiations with drugmakers Thursday, releasing its opening bids on lower prices for 10 of the most expensive, commonly prescribed drugs. These negotiations are part of the Centers for Medicare and Medicaid Services’ new powers to secure lower drug prices for 66 million older Americans.
Leading manufacturers, including Merck, Novo Nordisk and AstraZeneca have challenged this new program in recent months, filing at least nine lawsuits.
The drug firms argue that these negotiations are unprecedented and that the federal government is forcing them to accept low prices. CMS responds that it has been setting rates for physicians, labs and hospitals for decades, and if drugmakers don’t like the prices, they can drop out of Medicare.
The first ruling, from an Ohio judge appointed by President Trump, sided with the government; the other court decisions are still pending.
Georgetown’s Zach Baron says the drugmakers’ strategy is to draw judges’ attention away from the program’s details, and instead focus on whether federal bureaucrats are overstepping.
If Medicare ultimately carries the day, the new, negotiated prices for these drugs will go into effect in 2026, with further negotiations over other drugs to follow. Policy analysts say the negotiations could save Medicare close to $100 billion over the next decade, and save individual patients substantial amounts of money, too. On the other hand, if judges side with drugmakers, the federal government and older Americans could be stuck with stubbornly high prices.
A recent national poll from KFF shows issues like health care prices, the future of Medicare and Medicaid and abortion rights are among the top 10 things on voters’ minds. In a too-close-to-call clash of politics and the legal system, some of the most controversial of these court cases could be decided a few months ahead of the November elections.
Episode Transcript and Resources
Episode Transcript
Dan Gorenstein: This year comes with a packed docket of important court cases about health care.
Litigation about drug prices, abortion bans, gender affirming care and of course the old standby the Affordable Care Act.
Many of these cases have the potential to change Americans’ costs and access to care, and restrict the power of federal health agencies. Today we run through the cases we’re watching in 2024.
From the studio at the Leonard Davis Institute at the University of Pennsylvania, I’m Dan Gorenstein. This is Tradeoffs.
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DG: Health care policy experts are keeping close tabs on the courts this year.
Judges are ready to weigh in on health policies – new ones – like Medicare’s power to negotiate drug prices. And old – like Obamacare’s insurance rules. The ramifications of these decisions, some on politically charged issues, are especially important during an election year.
Reporter Producer Alex Olgin joins me to talk through the details of the cases.
Hi Alex.
Alex Olgin: Hi Dan.
DG: Alright Alex what is the first case you have for us?
AO: It’s actually nine cases. But they’re all about the same thing. Drugmakers want to stop Medicare from using it’s new power to negotiate drug prices for 66 million older Americans.
Congress gave Medicare this authority in 2022. The agency has spent the last year and a half coming up with the rules.
And Dan, basically the pharmaceutical companies are trying to shut the program down before it even starts.
News clip: AstraZeneca joining the likes of J&J, Merck, Bristol Myers as well as the not for profit AARP in the battle over drug pricing.
DG: Got it. So what are drugmakers like Merck, AstraZeneca and Janssen claiming.
News clip: Saying that being forced to negotiate drug prices with Medicare is, quote, tantamount to extortion.
AO: In short they are claiming this new program is unconstitutional.
They are saying how Medicare has picked the drugs to negotiate and the rules around this policy exceeds the authority Congress gave them. They argue the program is really government price setting dressed up as a negotiation.
Merck called the program a “gun to the head” to pharmaceutical companies.
DG: What’s the government’s defense?
AO: The government’s defense is that negotiating prices is really just business as usual.
Medicare has set rates for doctor visits, labs and hospital stays for decades. And the government says if companies find these rates too low, they can stop selling drugs to Medicare.
DG: Setting the overheated rhetoric aside, Alex. What have courts said about these arguments?
AO: Well we only have one ruling so far from a federal judge in Ohio. He agreed with the government, saying no matter how important Medicare is to a drug company’s business, drug makers are not compelled to sell to the program.
Zach Baron is a co-director of the Health Policy and the Law Initiative at the O’Neill Institute at Georgetown Law School.
Zach says drugmakers’ seem to be trying to leverage the view among some judges that federal bureaucrats have too much power.
Zach Baron: I think the general headwinds that we’re seeing [is that] the, The Supreme Court is more hostile to, , giving agencies, as much authority to, to carry out these programs without the close eye of the courts. That’s where. I do think those those headwinds could certainly create some, some issues in the drug negotiation cases.
AO: Basically, Zach says, drugmakers’ best hope may be riling up judges’ concerns over the so-called ‘Administrative state.’
DG: And how are these other cases looking, Alex?
AO: These cases are in the early stages so it’s hard to read the tea leaves.
Even if this first wave of cases are unsuccessful the lobbying group PhRMA warns more lawsuits may be on the way.
Final note on this, Dan. These negotiations are expected to save Medicare close to $100 billion over the next decade. And patients substantial amounts of money.
So if judges agree with drugmakers that means —- federal government and older Americans will be stuck with stubbornly high prices.
DG: Ok, Alex, we’ll keep watching that space. What’s the next case you’ve got for us?
AO: Believe it or not Dan. The Affordable Care Act.
DG: More than a decade’s worth of litigation on this law. Wow.
AO: As of September 2020 the ACA was the most challenged law in all of American history!
DG: Are you serious?
AO: Oh yes, I’m not kidding. More than 2000 cases challenging this one law.
DG: Damn, Alex. So I know the Supreme Court ruled three times on different parts of the law including the mandate to buy insurance, the tax penalty and contraception. What’s this one about?
AO: It’s actually about one of the most popular parts of the law.
The provision that gives us preventive care for free. Things like vaccines, mammograms, and medication to prevent HIV called PrEP. Again, all for free. The idea is to make it super easy to get the care we all know has a very positive effect on people’s health.
Now, a Texas business, Braidwood Management is challenging this rule.
Braidwood calls itself a Christian business and says, this rule forces them to pay for some PrEP and that violates their religious beliefs about sexuality.
Last year, a federal court in Texas agreed. The Biden administration has appealed and the courts have put any widespread changes are on hold at least until the appeals court hears the case. No date has been set.
DG: Ok good so my colon cancer screening is still free.
AO: Yea for now. But you know how we’ve been talking about agency authority, right? So this case raises that question, too.
The US Department of Health and Human Services picks experts to decide which medical care qualifies to be free.
One of the arguments is that those experts lack the power to make decisions because they were not confirmed by Congress.
DG: Ok this all sounds pretty technical, Alex. Getting into whether these experts have the proper authority or not.
AO: Yeah, Dan, it’s weedy for sure. But if the court sides with Braidwood, there are very real implications for patients, doctors and Congress.
Going forward, anytime this group of experts – who are called the United States Preventive Services Task Force – decides a new kind of medication should be free Congress would have to pass a law saying so.
DG: You mean the same Congress that struggles to pass our budget bills?
AO: Right exactly.
Legal experts I’ve spoken to, Dan, say this case could have bigger ramifications than that.
If courts limit agency authority like with the task force Zach Baron from Georgetown says it could gum up the federal government’s ability to function.
ZB: Think of Covid 19 and think of the importance of having, HHS and others to be able to make sure that, um, you know, that that that people are able to get the treatment they need to respond to evolving situations.
AO: Right now this case is before the Fifth Circuit appeals court in New Orleans. But the people I am talking to Dan expect it could end up before the Supreme Court.
DG: Another potential chance for justices to weigh in on Obamacare. After the break we dive into two abortion cases on the Supreme Court’s docket and the debate over gender affirming care.
MIDROLL
DG: We’re back talking about some of the most high-profile health policy court cases this year.
Reporter producer Alex Olgin joins me with more about the fights over regulating two controversial types of medical care. Abortions and gender affirming care for kids.
First abortion. Right after the Supreme Court overturned the constitutional right to abortion in June 2022 – conservative lawmakers focused on banning the procedure.
Today there are 14 states with total bans and 11 others that block the procedure at certain points in pregnancy. Alex, I’m curious, how has the fight over abortion access shifted in 2024?
AO: Well, Dan as you mentioned over the last two years – there has been lots of legislation focused on the point in pregnancy the bans would take effect: 6 weeks, 10 weeks, 15 weeks. And also for what kinds of exceptions – like rape or to keep the mom alive.
The fight now has moved to how these exceptions work in practice. Laurie Sobel is an Associate Director of Women’s Health Policy at KFF.
Laurie Sobel: The question in states is. How close to death do you need to be to get an abortion?
DG: That’s a question that stops you in your tracks.
AO: Yeah, and as we move into this more practical phase – when these laws are being tested – we need to remember these exemptions were written by lawmakers –not doctors and nurses.
So we are seeing instances now when clinicians are unsure what to do, how to care for pregnant people in medical distress. Based on reports – and these court cases – docs and nurses are scared and confused.
And it makes sense, the penalties for not following the law are big, like losing your medical license and prison time.
In some cases women and doctors are asking the courts what health problems count under the exceptions. Laurie says the doctors want assurance that the courts will let doctors have the last word.
LS: They want deference to their medical judgment. And anything short of that will not, um, allow doctors and hospitals to comfortably provide care without fear of prosecution.
AO: Adding another wrinkle here, Dan, doctors and even hospitals have to also think about federal law.
DG: Right, federal law says providers must stabilize patients in emergencies.
AO: Yeah, and the Biden administration has come out, saying that if that means a person needs an abortion, providers must give them an abortion.
DG: Even in states with these bans?
AO: So that’s the thing. One of the two cases in front of the Supreme Court this year asks that question. Does federal law supersede state law?
And Dan, this is not a hypothetical.
CMS determined last May two hospitals. One in Missouri and another in Kansas refused to provide an abortion to one woman who was at risk of losing her life.
DG: A violation of federal law.
AO: Exactly. This woman, Mylissa Farmer, had gone into premature labor meaning her fetus would definitely die and she could die.
But because doctors in both hospitals detected the baby’s heartbeat they declined to perform the procedure.
DG: What did the woman do?
AO: She ended up going to Illinois to get the abortion.
Laurie Sobel from KFF said these scenarios are antithetical to practicing medicine.
LS: I mean, can you imagine any other situation in which you’re told by your doctor, come back when you’re sicker? We know you’re going to get sicker, but you’re not sick enough right now for us to prevent you from getting sicker.
AO: So, Dan, we’re seeing instances like this pop up more and more because of the bans.
DG: And why is the Supreme Court getting involved?
Because one federal appeals court ruled Idaho must follow federal law in these emergencies and a different federal appeals court ruled the opposite for Texas.
So the Supreme Court will decide which law doctors and hospitals must follow.
DG: It’s interesting, Alex, when the Dobbs decision came down, Justice Alito wrote about how the ruling puts the question of abortion squarely in the hands of states.
Yet here we are back at the Supreme Court with two abortion cases this year. What’s the second one about?
AO: Essentially, how easily can people get mifepristone – the so-called abortion pill.
The ramifications could be huge Dan, because more than half of abortions are done with medication.
DG: Ok so Alex, what are the plaintiffs, a group of anti-abortion doctors in Texas, arguing.
AO: They say the FDA ignored safety concerns when the agency made it easier to get the drug over the last eight years, like getting a prescription after just one telehealth visit and or even having it delivered in the mail
DG: Ok Alex, as you’re saying, going back to the old medication rules would make it much harder to get the drugs. Earlier this year lower courts agreed with the plaintiffs and second guessed the FDA’s safety judgment. Has that ever happened before?
AO: Yeah it is. I mean the FDA’s approval has been considered the gold standard.
And Dan, more than 20 years of real world evidence show mifepristone is safe. Nearly 6 million women have taken it and less than 1 percent reported complications.
DG: Ok Alex, so the Supreme Court decision will determine if current rules for mifepristone stay or if we go back to more restrictive ones.
AO: Right Dan. And they’re also considering this bigger question of – can doctors even go to court to overrule FDA decisions.
This is the question that experts like Laurie at KFF worry about. Because it could open the door to people challenging all kinds of drugs. Maybe even common painkillers.
LS: “More likely it won’t be Tylenol. It will be PrEP… it’s highly effective, and it’s been a game changer in terms of changing the spread of HIV…and It’s definitely in the crosshairs of cultural wars, much in the way that medication abortion is.”
DG: Ok. So that’s abortion. Let’s tee up another type of medical care that’s part of the culture war. Gender-affirming care for kids.
Over the last few years at least 23 states have passed laws limiting or banning gender-affirming care for minors. Alex, we know families and doctors have gone to state courts around the country to block these bans. What’s the landscape like out there?
AO: Sure, so these bans prohibit things like medications or surgeries for transgender people under 18.
But some of these state laws go even further. Idaho and Alabama made it a felony to offer this care. For a little context, Dan, about a third of all transgender kids live in states with these bans, that’s about 100,000 people.
DG: What are those states arguing?
AO: Many lawmakers have talked about the dangers of getting this care – arguing minors are too young to make these decisions and could one day regret it.
Texas Governor Greg Abbott has gone farther. He directed state officials to label it child abuse if parents let their kids get this care.
But parents and professional groups like the The American Medical Association American Academy of Pediatrics say this is necessary and actually not getting it could even harm kids mental health.
DG: Alex I’ve heard about families either traveling out of state even moving to get these treatments. So Alex, what arguments are families making to challenge the bans?
AO: Transgender minors and their families argue that these bans are a form of sex discrimination.
Because they only ban these treatments for people who are transgender whereas the states allow these exact same medications for other medical problems like conditions with the ovaries and birth defects.
Judges in Arkansas and Idaho found that argument compelling.
DG: Ok Alex, and how are states defending themselves?
AO: States including Kentucky and Tennessee say since their laws apply equally to teens born male and female. They aren’t discriminating on sex.
Katie Eyer is a professor at Rutgers Law School and an expert in anti-discrimination law. She says that reasoning flies in the face of how courts have viewed equal rights laws for decades.
Katie Eyer: I think that argument relies on a sort of a separate but equal rationale, the idea that it equally burdens both groups….[but] that argument is simply wrong
AO: Katie says these are the same separate but equal arguments that states used back in the 1950’s to defend school segregation.
But appellate judges agreed with that reasoning and let bans stand in Alabama, Kentucky and Tennessee.
DG: Got it. Both families and the federal government have asked the Supreme Court to hear the case. Based on your reporting, do experts think that’s likely?
AO: The split decisions are placing pressure on the high court to settle this issue.
I want to point out legal experts and transgender rights activists say there’s more to this case than families seeking care for their teens.
Katie told me, these cases could end up being huge for health care access and even the civil rights of transgender people.
KE: I think it is very clear that we are at a moment where, uh, the courts are very much involved in deciding the constitutional rights of the transgender community… And that would be clearly significant to all of the other discriminatory laws that have recently been enacted targeting transgender people.
AO: Basically, if the courts side with states that have the bans, the thinking is that could undermine civil rights protections for transgender people.
We’ve already seen some states limit health insurance coverage for transgender adults and we’ve all heard about state laws barring kids from using bathrooms and joining sports teams that match their identity. These are the kinds of threats to people’s civil rights we’re talking about, Dan.
DG: Thanks for your reporting on this Alex.
AO: You’re welcome.
DG: Certainly a busy year for judges.
A national poll from KFF shows issues like health care prices, the future of Medicare and Medicaid and abortion rights are among the top 10 things on voters’ minds.
And it sounds like some of these decisions – some, maybe controversial – could be decided right around the election.
I’m Dan Gorenstein, This is Tradeoffs.
Episode Resources
Selected Research and Reporting on Court Cases
The Curious Rise of a Supreme Court Doctrine That Threatens Biden’s Agenda (Adam Liptak, New York Times, 03/06/2023)
What to Know About the Federal Law at the Heart of the Latest Supreme Court Abortion Case (Pam Belluck, New York Times, 01/19/2024)
SCOTUS is under pressure to weigh gender-affirming care bans for minors (McKenzie Beard, Washington Post, 11/27/2023)
The 19th Explains: The groundwork for a Supreme Court case on gender-affirming care is being laid now (Orion Rummler, The 19th, 10/12/2023)
Current And Future Legal Attacks Against The Medicare Drug Price Negotiation Program (Zachary Baron, Andrew Twinamatsiko, Health Affairs, 06/07/2023)
Clinical Implications Of The Braidwood Ruling: Use Of Pre-ACA Task Force Recommendations (Zoey Chopra, A. Mark Fendrick, Health Affairs, 05/02/2023)
Legal Challenges to the FDA Approval of Medication Abortion Pills (Laurie Sobel, Alina Salganicoff, and Mabel Felix, KFF, 03/13/2023)
Episode Credits
Guests:
- Zach Baron, JD, Co-director of Health Policy and the Law Initiative, O’Neill Institute for National and Global Health at Georgetown University Law Center
- Katie Eyer, JD, Professor at Rutgers Law School
- Laurie Sobel, JD, Associate Director of Women’s Health Policy at KFF
- Alex Olgin, Reporter/Producer, Tradeoffs
The Tradeoffs theme song was composed by Ty Citerman, with additional music this episode from Blue Dot Sessions and Epidemic Sound.
This episode was reported by Alex Olgin, edited by Deborah Franklin and Dan Gorenstein, and mixed by Andrew Parrella and Cedric Wilson.
Thanks to the Tradeoffs Advisory Board and our stellar staff!