Tuesday, June 17, 2025

Health law issues at the Supreme Court

There's a handful of cases before SCOTUS that have been argued and, with only a couple of weeks left in the Term, are still awaiting decision. At the bottom of this post, I've listed health law cases that will be argued during the 2025 Term.

  1. Ker:r v. Planned Parenthood South Atlantic, No. 23-1275: Whether the Medicaid Act's any-qualified-provider provision unambiguously confers a private right upon a Medicaid beneficiary to choose a specific provider. Argued: April 2, 2025.
  2. United States v. Skrmetti, No. 23-477Whether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow "a minor to identify with, or live as, a purported identity inconsistent with the minor's sex" or to treat "purported discomfort or distress from a discordance between the minor's sex and asserted identity," violates the equal protection clause of the 14th Amendment. Argued: Dec. 4, 2024.
  • There's an FDA case on the list of cases awaiting decision, but the issue is a technical, federal procedure one: Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer's products that is located within that circuit. FDA v. R.J. Reynolds Vapor Co., No. 23-1187.
The Court has granted review in 19 cases to be heard in the next Term, of which XX have a health law angle:
  1. Chiles v. Salazar, No. 24-539: In this conversion-therapy case, the issue is whether a law that censors certain conversations between counselors and their clients based on the viewpoints expressed regulates conduct or violates the free speech clause of the First Amendment. At least 20 states have similar laws. Review granted: March 10, 2025.
  2. First Choice Women's Resource v. Platkin, No. 24-781: (From SCOTUSBlog:) "Whether a group of crisis pregnancy centers – faith-based nonprofits that hold themselves out as healthcare clinics and often provide material support to pregnant women, but try to persuade them not to have an abortion – can go to federal court to challenge the constitutionality of a subpoena from a state attorney general, or whether they must instead pursue those claims in state court. . . . This case arose from an investigation by the state’s Division of Consumer Affairs into whether First Choice Women’s Resource Centers was misleading donors and potential clients – by, for example, omitting information about its mission on its client-facing websites and by indicating that ultrasounds are 'generally required' before a medication abortion, although they are not." Review granted: June 16, 2025. 

Monday, June 16, 2025

New VA Rules Allow Denials of Treatment Based on Political Party Affiliation, Marital Status

It sounds like a headline from The Onion, but it appears to be real. As reported by the Latin Times and others (cited below), "The VA, which serves over 9 million veterans across more than 170 hospitals and 1,000 clinics, revised its internal bylaws to strip longstanding protections against discrimination based on political party, marital status, sexual orientation and national origin."

I'm looking for copies of the old policy and the new one, which reportedly eliminated certain protections against discrimination in treatment. Meanwhile, you can get the gist of the changes in these early reports:

From The New Republic:

The new rule changes apply to professionals across disciplines, including doctors, certified nurse practitioners, psychologists, dentists, chiropractors, optometrists, podiatrists, licensed clinical social workers, and speech therapists.

Dr. Arthur Caplan, founding head of the division of medical ethics at New York University’s Grossman School of Medicine, told The Guardian that the VA’s new rules were “extremely disturbing and unethical.”

“It seems on its face an effort to exert political control over the VA medical staff,” Caplan said. “What we typically tell people in healthcare is: ‘You keep your politics at home and take care of your patients.’

“Those views aren’t relevant to caring for patients. So why would we put anyone at risk of losing care that way?” Caplan added.

The VA's explanation is no explanation at all: 

VA press secretary Peter Kasperowicz told The Guardian that the changes were just a “formality” made in order to comply with Trump’s executive order “defending women from gender ideology extremism and restoring biological truth to the federal government.” 

Thursday, June 12, 2025

"Four Ways Trump’s ‘One Big Beautiful Bill’ Would Undermine Access to Obamacare"

The nonpartisan Kasier Family Foundation (KFF) News service highlights some of the changes that won House approval and await consideration in the Senate. Presumably convinced that Obamacare won't get repealed anytime soon (after 60+ attempts to do so have failed), the GOP intends to kill it with a thousand cuts. Here are four:

1. Tax Credits Are Jeopardized by Enrollment Hassles

The House-passed bill, which runs more than 1,000 pages, would create paperwork requirements that could delay access to tax credits for some enrollees, potentially raising the cost of their insurance.

More than 90% of ACA enrollees receive tax credits to defray monthly premiums for their coverage. There are two key provisions for them to watch.

One would end automatic reenrollment for most ACA policyholders each year. More than 10 million people were automatically reenrolled in their coverage for the 2025 plan year, with their eligibility for tax credits confirmed via a system that allows ACA marketplaces to check government or other data sources.

The House bill would instead require every new or returning policyholder each year to provide information on income, household size, immigration status, and other factors, starting in 2028. If they don’t, they won’t get a premium tax credit, which could put the price of coverage out of reach.

“Everyone who wants to either purchase or renew a marketplace plan will have to come with a shoebox filled with documents, scan in and upload them or mail them in, and sit and wait while someone reviews and confirms them,” said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University.

She and other policy experts fear that many consumers will become uninsured because they don’t understand the requirements or find them burdensome. If too many young and healthy people, for example, decide it’s not worth the hassle, that could leave more older and sicker people for ACA insurers to cover — potentially raising premiums for everyone.

But supporters of the House bill say the current approach needs changing because it is vulnerable to waste, fraud, and abuse.

“This would ensure that enrollees need to return to the exchange to update their information and obtain an updated eligibility determination for a subsidy — best protecting the public against excess subsidies paid to insurers that can never be recovered,” the conservative Paragon Institute wrote in an April letter to top Department of Health and Human Services officials. 

 2. Having a Baby? Getting Married? Expect Coverage Delays

Today, people who experience life changes — losing a job, getting married or divorced, or having a baby, for instance — are considered provisionally eligible for tax credits to reduce their premiums if they sign up or change their ACA plans. That means they would be eligible to receive these subsidies for at least 90 days while their applications are checked against government data or other sources, or marketplaces follow up with requests for additional information.

The House bill would end that, requiring documentation before receiving tax credits. That could create particular hardship for new parents, who can’t confirm that babies are eligible for premium subsidies until they receive Social Security numbers weeks after they’re born.

Policy experts following the debate “did not expect the end to provisional eligibility,” Corlette said. “I don’t know what the reaction in the Senate will be, as I’m not sure everyone understands the full implications of these provisions because they are so new.”

It can take up to six weeks for the Social Security Administration to process a number for a newborn, and an additional two weeks for parents to get the card, according to a white paper that analyzed provisions of the House bill and was co-authored by Jason Levitis, a senior fellow at the Urban Institute, and Christen Linke Young, a visiting fellow with Brookings’ Center on Health Policy.

Without a Social Security number, any application to add a newborn to an ACA policy would automatically generate a hold on premium tax credits for that family, they wrote — increasing their out-of-pocket costs, at least temporarily.

“It puts consumers on the hook for any delays the marketplace is taking,” while the Centers for Medicare & Medicaid Services, which administers the ACA marketplaces, “is cutting staff and adding a lot more paperwork to burden the staff they have,” Levitis said.

Provisions in the House bill that would require ACA enrollees to provide information each year that they reenroll — or when seeking to add or change a policy due to a life circumstance — would increase the number of people without health insurance by 700,000 in 2034, according to the latest CBO estimate.

3. Less Time To Sign Up

The House bill would turn into law a Trump proposal to shorten the ACA open enrollment period. The start date would continue to be Nov. 1. But the window would be shortened by about a month, with an end date of Dec. 15. This affects people in states that use the federal marketplace as well as the 19 states and the District of Columbia that run their own, most of which offer open enrollment into at least mid-January.

Also, as soon as the end of this year, a special enrollment period the Biden administration created would be done away with. It allowed people with lower incomes — those who earn up to 1.5 times the 2024 federal poverty level, or about $38,730 for a family of three — to sign up anytime during the year.

Critics, including the Paragon Institute, argue that this enrollment opening led to fraud, partly blaming it for a steep increase last year in instances of insurance agents seeking commissions by enrolling or switching consumers into plans without their consent, or fudging their incomes to qualify them for tax credits so large they paid no monthly premiums at all.

But supporters — including some states that run their own ACA exchange — say there are other ways to address fraud.

We anticipate that much of the improper activity can be prevented by security and integrity upgrades to the federal marketplace, which we understand the Centers for Medicare and Medicaid Services (CMS) is implementing,” the National Association of Insurance Commissioners wrote in a May 29 letter to congressional leaders

4. Premiums and Out-of-Pocket Costs Will Likely Increase 

The reason? Enhanced tax credits created during the pandemic expire at the end of the year. The House bill doesn’t extend them. Those more generous payments are credited with helping double ACA enrollment since 2020.

The CBO estimates that extending the subsidies would cost $335 billion over 10 years. The House bill instead funds an extension of Trump’s tax cuts, which largely benefit wealthier families.

If the enhanced credits are allowed to expire, not only would premium subsidies be smaller for many people, but there would also be an abrupt eligibility cutoff — an income cliff — for households above four times the federal poverty rate, or about $103,280 for a family of three for this plan year.

Taking into account the smaller subsidies and the cliff, KFF estimates a national average premium increase of 75% for enrollees if the enhanced subsidies expire. The CBO expects that about 4.2 million more people will be uninsured in 2034 as a result.

KFF continues: "Additional, potentiallu devastating, changes also would come from regulations the Trump administration proposed in March and the potential expiration of larger premium subsidies put in place during the covid-19 pandemic.

"Millions of people might drop or lose coverage by 2034 as a result, according to the nonpartisan Congressional Budget Office.

"Combined, the moves by Trump and his allies could “devastate access” to ACA plans, said Katie Keith, director of the Center for Health Policy and the Law at the O’Neill Institute, a health policy research group at Georgetown University. 

Wednesday, June 11, 2025

"Live Free. Kids Die?"

That's the title of a blog post from The Boston Globe. Here's the entry:

Live free, kids die? The rate of childhood firearm fatalities in New Hampshire has doubled since a 2010 Supreme Court ruling in McDonald v. Chicago expanded the Second Amendment right to keep firearms in the home, according to a new JAMA Pediatrics study released this week. That gives the Granite State, which has among the most permissive gun laws in the nation, the distinction of also having the country’s highest-rising firearm child mortality rate since the ruling. “It’s a really important study that shows … that permissive firearm laws are associated with greater pediatric firearm death,” Kelly Drane, research director at the Giffords Law Center, told the Globe’s Amanda Gokee. “It shows the benefit of states taking action to protect children.” A reminder to everyone, including the justices and Health and Human Services Secretary Robert F Kenney [sic], Jr.: Guns are the top killer of children in America, and remain a public health crisis crying out for attention.

That last sentence is exactly what I and many others have been saying for years. The availability of guns has led to thousands upon thousands of premature deaths, just as surely as killer microbes, car accidents, and lousy genetic luck, and public health responses -- sometimes with difficulty -- have met the challenge. The difference is there's nothing in the U.S. Constitution that embraces these causes of injury and death, but there is the Second Amendment's statement that "the right of the people to keep and bear Arms, shall not be infringed." There are sensible ways to read this provision.* When will the states, Congress, and the Justices of the U.S. Supreme Court come to their senses? 

__________

* See, e.g., Blocher & Ruben, Originalism-by-Analogy and Second Amendment Adjudication," Yale L.J. (2023-24) {https://www.yalelawjournal.org/article/originalism-by-analogy-and-second-amendment-adjudication}; Ruben, "Law of the Gun: Unrepresentative Cases and Distorted Doctrine," Iowa L. Rev (2021) {https://ilr.law.uiowa.edu/sites/ilr.law.uiowa.edu/files/2023-02/A4_Ruben.pdf}. 

 

Tuesday, June 10, 2025

New Article on Regulation of Abortion and Federal/State Divide

My colleagues, Profs. Joanna Grossman and Nathan Cortez, have published an important article: "Who Regulates Abortion Now?," 110 Iowa L. Rev. 1579 (2025). Their article dispels the notion -- promulgated by the Supreme Court in its Dobbs decision and widely accepted -- that abortion regulation has been returned to the states. Not so fast, they argue, in light of the Food & Drug Administration's regulatory control of the means by which a substantial majority of abortions are now obtained: abortion drugs such as mifepristone.

The authors argue, quite convincingly, that federal regulation of abortion medications plays a substantial role in the day-to-day reality of abortion medicine and that federal law has been superior to state law in this regard:

We argue that most patients want medicine to be evidence-based (applying the best scientific and medical knowledge available at the time), ethical (adhering to the ethical standards adopted by professional societies), consistent (encouraging similar care for similarly-situated patients), and individualized (accounting for each patient’s specific needs, preferences, and circumstances). Our laws and regulations should prioritize, not frustrate, these values. We then show that federal regulation has been superior at encouraging these values, while state regulation in abortion-restrictive states undermines these values, resulting in medical care that is less evidence-based, less ethical, less consistent, and less individualized in service of “winning” deeply-contested moral and ideological debates.

The entire article is indispensable reading for anyone who wants to understand not only the ongoing abortion debate, but much more:

Just as before Dobbs, federal authorities continue to determine which drugs can be prescribed while state authorities help define the permissible scope of medical practice. However, since Dobbs, several states have tried to ban the use of a medication approved as safe and effective by federal regulators. What should we do when concurrent oversight over “medicine” by state and federal authorities clashes in this way?

In the long term, these disputes are about more than just preemption; they are about how we regulate medicine in a world of telehealth, remote prescribing, and health care delivery models that increasingly blur the line between medical practice (regulated by states) and medical products (regulated at the federal level). These disputes also speak to ongoing battles over the permissibility of gender-affirming care, the regulation of laboratory-developed tests (“LDTs”), and other evolutions in medicine. Thus, the question “Who regulates abortion now?” is also a question of “Who regulates medicine now?” 

Tuesday, May 06, 2025

LGBTQ+ in the Supreme Court: Today's Order

Much will be made in the press of today's brief, unsigned order (to which Justices Sotomayo, Kagan, and Jackson dissented without opinion). The case involved Pres. Trump's Jan. 27 Executive Order 14183 with the Orwellian title, "Prioritizing Military Excellence and Readiness." 

Seven transgender serivce personnel challenged the EO in federal district court. Lead plaintiff is Commander Emily Shilling, a veteran Navy combat pilot who served in two wars and is now a Navy test pilot. The trial judge issued an preliminary injunction against enforcement of the EO until there could be a deision on the merits of the challengers' claims, and the Ninth Circuit Court of Appeals declined to stay the lower court's order. (Click here.) Today's Supreme Court order granted that stay:

This is not your usual procedural order to preserve the status quo pendente lite:
  1. By lifting the lower court's injunction, the Court has allowed the DOD to proceed with its purge of transgender service members. 
  2. That purge began on Feb. 26 and can now resume:

    "On Feb. 26, the Department of Defense issued that ban, which generally disqualifies anyone who either has gender dysphoria or has undergone medical interventions to treat gender dysphoria from serving in the military. The department explained that 'the medical, surgical, and mental health constraints on individuals who have a current diagnosis or history of, or exhibit symptoms with, gender dysphoria are incompatible with the high mental and physical standards necessary for military service.'" (SCOTUSBlog, May 6)

  3. It is a little unclear exactly what standard the Court is using these days to decide on stay motions on its emergency docket. Ordinarily a major factor is whether the party seeking relief is likely to prevail on the merits of the underlying litigation. If this order is based upon such a weighing of probabilities, it's bad news for the challengers.
Why cover this development in HealthLawBlog? Because also pending on the Court's calendar is United States v. Skrmetti, No. 23-477, in which this is the issue: Whether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow "a minor to identify with, or live as, a purported identity inconsistent with the minor's sex" or to treat "purported discomfort or distress from a discordance between the minor's sex and asserted identity," violates the equal protection clause of the 14th Amendment. Oral argument was held on Dec. 4, after which it was reported that the Court appears ready to uphold Tennessee's ban. 

Friday, May 02, 2025

Krugman: MAGA's War on Science

My last final exam is finally ready for prime time (Mon., May 5, at 1:30: Legislation and Regulation, a required 1L course; I wish my students good luck on the exam).

Grading will begin Tuesday morning.

So this is a perfect time to blog a little something, which I haven't done since February. After my grades are in, I will be on sabbatical for a year, followed by retirement on May 31, 2026. This year I'll be finishing a student treatise on health law regulation and compliance (state and federal), public health law, bioethics, and medical malpractice. Not sure whether blogging fits into that task, at least until September when my draft is due to the publisher.

If it hadn't been for an eye-catching email from Paul Krugman this morning, I probably wouldn't be blogging this afternoon, but his thoughts are compelling for anyone who cares about scientific research in general or medical research in particular. I republishing his email below in the hope that he won't find out won't mind, because his email starts with this: "Forwarded this email? Subscribe here for more." In lieu of literally forwarding his email to you (impossible to do), I'm forwarding in the best way available to me. But definitely subscribe. In my perennially overstuffed Inbox, his messages are among the handful that I genuinely look forward to reading.

So much for the prelude. Now comes Krugman, unvarnished.

Many of us have long noted the growing hostility of the G.O.P. to science. But my experience was that many people viewed those raising the alarm — like Chris Mooney, who wrote a 2005 book titled The Republican War on Science — as over the top scaremongers.

But at this point, can we acknowledge that MAGA is indeed waging war on science? Not just “woke” stuff, but science in general.

Nature tells us that National Science Foundation funds have been frozen, and that even if some money eventually flows again, funding will be heavily politicized:

Staff members at the US National Science Foundation (NSF) were told on 30 April to “stop awarding all funding actions until further notice,” according to an email seen by Nature.

The policy prevents the NSF, one of the world’s biggest supporters of basic research, from awarding new research grants and from supplying allotted funds for existing grants, such as those that receive yearly increments of money. The email does not provide a reason for the freeze and says that it will last “until further notice”.

Earlier this week, NSF leadership also introduced a new policy directing staff members to screen grant proposals for “topics or activities that may not be in alignment with agency priorities”. Proposals judged not “in alignment” must be returned to the applicants by NSF employees. The policy has not been made public but was described in documents seen by Nature.

In effect, NSF, if it supports research at all, will only support research that tells MAGA what it wants to hear. Add in RFK Jr.’s savage cuts at the National Institutes of Health, budget cuts at the National Oceanic and Atmospheric Administration and the Trump administration’s attacks on research universities, and we’re looking at a near-collapse of U.S. science. I don’t mean a hypothetical collapse a few years down the road, but the destruction of large parts of the American scientific enterprise — the envy of the world just a few months ago — this year.

Why should those who aren’t scientists care? In the 21st century, science isn’t some esoteric intellectual affair. It’s the foundation of social and economic progress. And no, we can’t expect the private sector to fill the gap left by loss of government support. Basic research is a public good: it generates real benefits, but those benefits can’t be monetized because everyone can make use of the knowledge gained. So government support is the only way to sustain science. And that support is being rapidly ended.

But why do our new rulers want to destroy science in America? Sadly, the answer is obvious: Science has a tendency to tell you things you may not want to hear. Medical research may tell you that vaccines work and don’t cause autism. Energy research may tell wind power works and doesn’t massacre birds.

And one thing we know about MAGA types is that they are determined to hold on to their prejudices. If science conflicts with those prejudices, they don’t want to know, and they don’t want anyone else to know either. So they really want to destroy science.

Again, this isn’t hyperbole, and it’s not about the long run. American science is being gutted as you read this.

Monday, February 03, 2025

I Really Didn't Plan to Post Anything Until My Next Sabbatical, But It's Time to Get Real (Part II)

The new administration is systematically undoing years and decades of support for the sorts of health- and medicine-related web posts and publications, as I described  in yesterday's blog post. A few concrete examples to illustrate the author's claims:

-- ABC News: Multiple Health Agency Websites On HIV, Contraception Taken Down To Comply With Executive Orders (KFF News, 2/3/2025):

Government agency webpages about HIV, LGBTQ+ people and multiple other public health topics were down as of Friday evening due to President Donald Trump's executive orders aimed at gender ideology and diversity, equity and inclusion. Some of the terms being flagged for removal include pregnant people, chestfeeding, diversity, DEI and references to vaccines, health and gender equity, according to officials at the Centers for Disease Control and Prevention who spoke to ABC News on the condition of anonymity. Entire databases have also been temporarily removed. (Wang, Portnoy, Haslett, Brownstein and Benadjaoud, 1/31)

-- One day after the inauguration, OMB instructed staff at agencies inside the Department of Health and Human Services to stop all external communications. The affected agencies included the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health. As reported by the Washington Post, "The pause on communications includes scientific reports issued by the CDC, known as the Morbidity and Mortality Weekly Report (MMWR); advisories sent out to clinicians on CDC’s health alert network about public health incidents; data updates to the CDC website; and public health data releases from the National Center for Health Statistics, which tracks myriad health trends, including drug overdose deaths."

Sunday, February 02, 2025

I Really Didn't Plan to Post Anything Until My Next Sabbatical, But It's Time to Get Real (Part I)

A niece of a retired law-school colleague is a Clinical Professor of Emergency Medicine at UCLA Medical School. She reposted a message from a colleague that deserves to be heard far and wide. Please read carefully:

Shared from a colleague (Sunny Smith):

For those who may not be a physician or aren’t in physician communities - yes, it’s true, it’s actually true.  

The United States government has required our leading health agencies to remove basic information on guidelines and best practices used every day for medical care and public health.   For treatment and prevention.   Every day clinical care.  

This has to be one of the most surreal (and terrifying) times in modern history. 

They have taken down information on antibiotics, antivirals, sexually transmitted infections, contraception, vaccines, and gender related issues.  

Physicians are outraged and alarmed.   

Physicians are banding together to obtain and share the information they need to treat patients.     They are literally saying “i have the guidelines for this, does anyone have guidelines for that”.  

Emergency physicians. Pediatricians.  OB Gyns.  Primary care.  

Real physicians.  Real conversations.  

This is not a dress rehearsal.  

We won't keep quiet and many are screaming from the rooftops.  

If you are not alarmed, you should be.  

11 days into this administration and by 5pm Friday our nation's health organizations have been forced to take down crucial health information. 

This is “Defending women from gender ideology” ?!?!?!!!!!!!! 

Let’s be very very very clear - this is NOT defending women.  

Do not be gaslit for one second that any of this is to protect women.   

That is the absolute antithesis of what this does to women.  And the whole population. 

This Executive Order alongside DEI EOs and blaming DEI for plane crashes. 

DO. NOT. BELIEVE. THESE. LIES.  

DEI did not cause plane crashes. 

Helping physicians treat infections or prevent pregnancies is not bad. 

The shock and awe and overwhelm and division and othering and inciting fear is intentional. 

Please speak up.  Anywhere and everywhere.   The compound effect of real people talking to other real people matters.  

You are not powerless.  They just want you to think you are.  Who wins when you think that? 

They can not paralyze over 300 milllion people.   

The way out of learned helplessness is to take small actions over and over again.  To take control anywhere within your own locus of control.   

And - Even if you were on the fence before or voted for him or are in a red state - PLEASE - consider having a tiny bit more opennness to start to question what is happening right now.  Look at data.  (May we all become increasingly aware of and question our own internalized bias, implicit or explicit bias, assumptions, racism, misogyny).

If you trust your LIFE to physicians, during any truly imminently life-threatening emergency for you or your loved ones, please listen when we say this is NOT okay.

Edited to add (after a physician colleague shared this immediately)  ->  Feel free to share.

In Part II I will provide some links to the Executive Orders and missing web pages.