Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Monday, June 30, 2025
Tracking the Changes in the Senate's Reconciliation Bill (Updated Daily)
Sunday, June 29, 2025
The Coming Health Care Apocalypse
After a quick review of what Obamacare did and didn't accomplish, Krugman writes:
[I]t led to a large decline in the number of Americans without health insurance. It also led to a large reduction in anxiety among Americans with preexisting conditions, who no longer had to fear being denied coverage or being trapped in jobs with health benefits for fear of losing coverage.
Essentially all these gains are about to be wiped out.
Apocalyptic sounds about right. Here's a graphic representation of the impact:
Basically, we’re talking about undoing all the progress America has made in expanding health insurance. And as I said, many independent analysts believe it could be substantially worse.Remember, this isn’t happening to save money: If Republicans cared about the deficit, they could forego those tax cuts. It isn’t happening by popular demand: the Big Beautiful Bill is extremely unpopular already, and will become even more unpopular once people see its effects.
So why is this happening? Krugman's take on the situation is hard to resist:
It’s happening because our government has been taken over by fanatics who believe that, one way or another, they can escape the electoral consequences of making millions of Americans’ lives much, much worse.
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* You can follow Krugman for free on Substack or, for a small monthly fee, you can get extended commentary. Either way, it's a good deal.
Friday, June 27, 2025
Trump Administration v. Rule of Law Redux
Professor Austin Sarat (Amherst College) is all over this one, arguing that the DOJ effort in this case shows yet again the disdain this administration has for the rule of law. It's a brief op-ed in Slate and worth the four minutes it takes to read.
As I wrote on Wednesday, respect for the rule of law -- particularly the law of the Constitution -- is exactly what our officials swear to uphold when they take their oath of office. And the Trump lawyers, among and above all others, should know better.
None of this bodes well for future health-law cases, which depend upon a fair reading of constitutional and statutory precedents, not the current DOJ's strong suit.
Thursday, June 26, 2025
The Supreme Court's "Disastrous Decision"
- Sotomayor, J.:
In matters of life and death, it is best to proceed with caution. In this case, the Government took the opposite approach. It wrongfully deported one plaintiff to Guatemala, even though an Immigration Judge found he was likely to face torture there. Then, in clear violation of a court order,
it deported six more to South Sudan, a nation the State Department considers too unsafe for all but its most critical personnel. An attentive District Court’s timely intervention only narrowly prevented a third set of unlawful removals to Libya.
Rather than allowing our lower court colleagues to manage this high-stakes litigation with the care and attention it plainly requires, this Court now intervenes to grant the Government emergency relief from an order it has repeatedly defied. I cannot join so gross an abuse of the Court’s equitable discretion. . . .
It is axiomatic, moreover, that when Congress enacts a statutory entitlement, basic procedural due process protections attach. Mathews v. Eldridge, 424 U. S. 319, 332 (1976). Congress expressly provided noncitizens with the right not to be removed to a country where they are likely to be tortured or killed. See 8 U. S. C. §1231 note. As this Court has explained, the “‘right to be heard before being condemned to suffer grievous loss of any kind . . . is a principle basic to our society.’” Mathews, 424 U. S., at 333 (quoting Joint Anti-Fascist Refugee Comm. v. McGrath, 341 U. S. 123, 168 (1951) (Frankfurter, J., concurring)). Being deprived of the right not to be deported to a country likely to torture or kill you plainly counts. Thus, plaintiffs have a right to be heard. . . .
There is no evidence in this case that the Government ever did determine that the countries it designated (Libya, El Salvador, and South Sudan) “w[ould] not torture” the plaintiffs. Application for Stay of Injunction 29. Plaintiffs merely seek access to notice and process, so that, in the event the Executive makes a determination in their case, they learn about it in time to seek an immigration judge’s review. The Fifth Amendment unambiguously guarantees that right. . . .
The Due Process Clause represents “the principle that ours is a government of laws, not of men, and that we submit ourselves to rulers only if under rules.” Youngstown Sheet & Tube Co. v. Sawyer, 343 U. S. 579, 646 (1952) (Jackson, J., concurring). By rewarding lawlessness, the Court once again undermines that foundational principle. Apparently, the Court finds the idea that thousands will suffer violence in farflung locales more palatable than the remote possibility that a District Court exceeded its remedial powers when it ordered the Government to provide notice and process to which the plaintiffs are constitutionally and statutorily entitled. That use of discretion is as incomprehensible as it is inexcusable. Respectfully, but regretfully, I dissent.
- Vladeck:
As long-time readers of this newsletter know, I’m not prone to hyperbole. But the title of this piece refers to today’s ruling as “disastrous.” In my view, that’s true for two reasons:
First, it is going to have massive effects. Keep in mind that, in a pair of similarly unexplained grants of emergency relief to the Trump administration last month, the Court cleared the way for the government to treat as many as one million migrants as removable who weren’t previously (including those with “temporary protected status” and those covered by a humanitarian parole program started by the Biden administration. Those folks can now not only be placed in removal proceedings, but even if they can’t be removed to their countries of origin, they can apparently be removed to other countries without additional process—at least until and unless something changes.
Second, and even more importantly, here is one of the most stark examples to date of the Trump administration overtly defying rulings by a federal district judge. Indeed, it did so twice in this case. For the Court to not only grant emergency relief in this case, but to offer nary a word of explanation either in criticism of the government’s behavior, or in defense of why it granted relief notwithstanding that behavior, is to invite—if not affirmatively enable—comparable defiance of future district court orders by the government. I would’ve thought that this was a message that this Supreme Court would be ill-inclined to send, even (if not especially) implicitly. But it’s impossible to imagine that the Trump administration will view it any other way. - Stohr:
[T]he Supreme Court’s majority has essentially washed its hands of its role in upholding the rule of law, the foundational principle that laws are meant to be followed by everyone, the government included, if we are to have a just society.
I don’t know how this court comes back from such an astonishing abrogation of its role at the top of a separate, coequal branch of government tasked with, among other things, being a check against tyranny from the executive branch. If last year’s ruling granting Trump broad immunity for illegal acts committed during his presidency was the shot, this week’s order was the bitter chaser.
For all the litigants (present and future) whose legal arguments depend upon the Court's interpretation of the Due Process and Equal Protection Clauses of the Constitution, hold onto your seats. If this case is any indication, it's going to be a bumpy ride.
Wednesday, June 18, 2025
SCOTUS Upholds Tennessee's Prohibition Against Transgender Treatments for Minors
The Chief Justice described rational-basis review this way: "Under this standard, we will uphold a statutory classification so long as there is 'any reasonably conceivable state of facts that could provide a rational basis for the classification.'” He concluded that the Tennessee law "clearly meets this standard." Indeed, you can count on the fingers of one hand the number of Supreme Court cases in which the government's action failed the rational-basis test.
So the real battle in this case was over the correct standard of judicial review, an issue that is often -- as it was here -- dispositive, even if -- as it was here -- it was hotly contested. How wide and deep was the disagreement? Here's the lineup of opinions:
- ROBERTS, C. J., delivered the opinion of the Court, in which THOMAS, GORSUCH, KAVANAUGH, and BARRETT, JJ., joined, and in which ALITO, J., joined as to Parts I and II–B.
- THOMAS, J., filed a concurring opinion.
- BARRETT, J., filed a concurring opinion, in which THOMAS, J., joined.
- ALITO, J., filed an opinion concurring in part and concurring in the judgment.
- SOTOMAYOR, J., filed a dissenting opinion, in which JACKSON, J., joined in full, and in which KAGAN, J., joined as to Parts I–IV.
- KAGAN, J., filed a dissenting opinion.
To give meaning to our Constitution’s bedrock equal protection guarantee, this Court has long subjected to heightened judicial scrutiny any law that treats people differently based on sex. See United States v. Virginia, 518 U. S. 515, 533 (1996). If a State seeks to differentiate on that basis, it must show that the sex classification “serves important governmental objectives and that the discriminatory means employed are substantially related to the achievement of those objectives.” Ibid. (internal quotation marks omitted). Such review (known as intermediate scrutiny) allows courts to ascertain whether the State has a sound, evidence-based reason to distinguish on the basis of sex or whether it does so in reliance on impermissible stereotypes about the sexes. Today, the Court considers a Tennessee law that categorically prohibits doctors from prescribing certain medications to adolescents if (and only if) they will help a patient “identify with, or live as, a purported identity inconsistent with the minor’s sex.” Tenn. Code Ann. §68–33– 103(a)(1)(A) (2023). In addition to discriminating against transgender adolescents, who by definition “identify with” an identity “inconsistent” with their sex, that law conditions the availability of medications on a patient’s sex. Male (but not female) adolescents can receive medicines that help them look like boys, and female (but not male) adolescents can receive medicines that help them look like girls.Tennessee’s law expressly classifies on the basis of sex and transgender status, so the Constitution and settled precedent require the Court to subject it to intermediate scrutiny. The majority contorts logic and precedent to say otherwise, inexplicably declaring it must uphold Tennessee’s categorical ban on lifesaving medical treatment so long as “‘any reasonably conceivable state of facts’” might justify it. Ante, at 21. Thus, the majority subjects a law that plainly discriminates on the basis of sex to mere rational-basis review. By retreating from meaningful judicial review exactly where it matters most, the Court abandonstransgender children and their families to political whims.In sadness, I dissent.
Tuesday, June 17, 2025
Health law issues at the Supreme Court
- 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.
- United States v. Skrmetti, No. 23-477: 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. 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.
- 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.
- 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
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:
- VA Doctors Can Refuse to Treat Dems After Trump Order, Daily Beast, June 16, 11:14 AM EDT
- New VA policy sparks outrage as doctors may refuse treatment to Democrats and unmarried veterans alike, Economic Times (India, English version), June 15, 2025 10:41 PM (-5 GMT)
- ‘Extremely disturbing and unethical’: new rules allow VA doctors to refuse to treat Democrats, unmarried veterans, The Guardian, Jun 16 2025 06.00 EDT
- Trump's 'disturbing' order lets veteran doctors deny care to Democrats or unmarried veterans, Irish Star, 11:53 ET, 16 Jun 2025
- Unhinged Trump Order Lets VA Doctors Refuse to Treat Democratic Vets; Doctors can also refuse treatment to unmarried veterans, The New Republic, June 16, 2025/12:40 p.m. ET
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"
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?"
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?
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* 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
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?”