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Monday, April 21, 2025

US FDA suspends milk quality control tests amid workforce cuts

 The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products due to reduced capacity in its food safety and nutrition division, according to an internal email seen by Reuters.

The suspension is another disruption to the nation's food safety programs after the termination and departure of 20,000 employees of the Department of Health and Human Services, which includes the FDA, as part of President Donald Trump's effort to shrink the federal workforce.

The FDA this month also suspended existing and developing programs that ensured accurate testing for bird flu in milk and cheese and pathogens like the parasite Cyclospora in other food products.

Effective Monday, the agency suspended its proficiency testing program for Grade "A" raw milk and finished products, according to the email sent in the morning from the FDA's Division of Dairy Safety and addressed to "Network Laboratories."

Grade "A" milk, or fluid milk, meets the highest sanitary standards.

The testing program was suspended because FDA's Moffett Center Proficiency Testing Laboratory, part of its division overseeing food safety, "is no longer able to provide laboratory support for proficiency testing and data analysis," the email said.

HHS did not immediately respond to a request for comment. The Trump administration has proposed cutting $40 billion from the agency.

The FDA's proficiency testing programs ensure consistency and accuracy across the nation's network of food safety laboratories. Laboratories also rely on those quality control tests to meet standards for accreditation.

"The FDA is actively evaluating alternative approaches for the upcoming fiscal year and will keep all participating laboratories informed as new information becomes available," the email said.

https://www.yahoo.com/news/us-fda-suspends-milk-quality-211319846.html

White House Announces Drug Policy Priorities, Including Expanded Naloxone, Fentanyl Test Access

 A recently released statement on Trump administration’s drug policy priorities called for a focus on stopping illicit drugs from coming into the United States, prosecuting those responsible for overdose deaths, expanded access to naloxone, and new campaigns “to inform the American people of the dangers of illicit drug use, the hope of a life in recovery, and the ways to prevent an overdose death.”

The administration’s plans to address opioid use disorder (OUD) include encouraging state and local authorities to “increase the availability of drug test strips and naloxone” and that it would also support efforts to connect people using drugs to supportive services, diverting them from incarceration.

Released in early April, the Statement of Drug Policy Priorities comes from the Office of National Drug Control Policy, which has traditionally been the locus of addiction policy and has helped guide the response to the opioid epidemic.

The office does not yet have a permanent leader. In late March, President Donald Trump nominated Sara A. Carter, a former Fox News journalist, to the post. Carter, whose appointment requires Senate confirmation, has reported on drug cartels and immigration. 

The White House said in a statement it will seek to ensure that “effective, timely, and evidence-based treatment is available to all Americans who need it,” including expanding access to medications for OUD and strengthening the peer recovery support services workforce.

Brian Hurley, MD, president of the American Society of Addiction Medicine (ASAM), said in a statement that the organization “is pleased to see the Trump Administration prioritize efforts to make evidence-based substance use disorder (SUD) treatment readily available.” 

ASAM urged the White House to also direct the Drug Enforcement Administration (DEA) to modify a regulation that keeps methadone for the treatment of OUD restricted to a single type of federally defined program.

Another priority for drug policy will be drug use prevention. The administration will use evidence-based prevention programs in schools and use social media to promote healthy behaviors, warn of the dangers of illicit drug use, and educate Americans on how to access treatment and recovery services.

In February, the US Centers for Disease Control and Prevention (CDC) reported that it estimates there will be a nearly 24% decline in drug overdose deaths for the 12 months ending in September 2024. Provisional data showed that some 87,000 Americans died from a drug overdose from October 2023 to September 2024, down from 114,000 the previous year. The CDC said that would be the fewest overdose deaths in any 12-month period since June 2020.

Meanwhile, the statement from the Office of National Drug Control Policy did not say whether the Trump administration would pursue or block reclassifying marijuana from a Schedule 1 to a Schedule 3 substance, a process that began under the previous administration. In May 2024, the US Department of Justice proposed the reclassification, as reported by Medscape Medical News.

After a public comment period, the DEA was due to hold hearings on the issue in December 2024. Those hearings were postponed and then delayed again in January as multiple parties sued, alleging that the agency had engaged in misconduct.

Two of the parties to the suits, Village Farms International and Hemp for Victory, “are awaiting action from DEA,” according to their attorney, Shane Pennington, with Blank Rome in Houston.

Thirty-nine states, three territories, and Washington, DC, allow the medical use of cannabis, whereas 24 states, three territories, and the District of Columbia allow or regulate recreational use, according to the National Council of State Legislatures.

https://www.medscape.com/viewarticle/white-house-announces-drug-policy-priorities-including-2025a10009jw

'Chinese Plastics Factories Face Mass Closure As US Ethane Disappears'

 Previously we explained that the US-China trade war has been unique in that the US was hit fast and hard, mostly through capital markets and financial linkages, which travel instantaneously with acute consequences (the recent dump of US treasuries by China and subsequent purchases of the yuan and perhaps gold took effect in milliseconds, and prompted a cottage industry of narratives how the US dollar is losing its reserve currency status). At the same time, the impact to the Chinese economy takes a while to propagate, as supply chains take weeks if not months to normalize to a new status quo; the period is even longer when the frontrunning of tariffs meant China would overproduce in the days leading up to the outbreak of the trade war, and keep economic output artificially inflated, as demonstrated by the paradoxically strong Q1 GDP numbers out of Beijing. Yet once the slowdown hits, as it inevitably will, the consequences for China - which unlike the US has no social safety net - will be far more dire. It also means that the trade war with China will apex only once Beijing suffers max pain, at which point Xi will be far more amenable to talks with Trump. The only question is when will said max pain moment hit.

We don't know yet, although we are keeping a close eye on alternative Chinese economic indicators (one can't trust official Chinese data in normal times, and one certainly can't trust any local "data" at a time when gepolitical leverage is measured in growth basis points, even if they are completely fabricated) for the tipping point. 

Until then, however, there are growing signs that the first wave of pain has already landed, and as Bloomberg reports, Chinese plastics factories that depend on a gas they mainly import from the US are contending with the prospect of widespread shutdowns as the world’s two largest economies bunker down for a prolonged trade war.

The world’s dominant plastics manufacturer gets almost all its ethane, a petrochemical feedstock that is also a component of natural gas, from the US. But eye-watering tariffs on American goods mean plants that cannot process substitute raw materials will bleed money; their only alternative is to mothball production for the near (or not so near) future.  

"The situation is dire for China’s ethane crackers as they have no alternative to US supply,” said Manish Sejwal, an analyst at Rystad Energy AS, using an industry term for such facilities. "Unless they are granted tariff exemptions, they may have to stop production or close shop."

Needless to say, that would be catastrophic for China's plastics industy.

Most so-called crackers in China use naphtha as a feedstock, with processors that solely use ethane as raw material for petrochemicals making up is less than 10% of the total at about 4 million tons, according to Rystad. China is by far the biggest buyer of American supply, according to the US Energy Department.

But with 125% tariffs in place, factories would have lost $184 for every ton of US ethane they processed in the week ending April 11, according to Rystad data. That compares with more than $100 they would have made in profits if there were no tariffs. 

According to Bloomberg, the extra costs are another blow for China’s plastics sector, which is already dealing with a glut as the growth in production capacity exceeds demand. The tussle is also threatening other feedstocks, including natural gas liquids and propane, and has led to sharp drops in US prices, hardly the inflationary shock so many have predicted.

Across China, domestic ethane production won’t be able to plug the gap, with the nation producing around 120,000 tons in 2024, according to industry consultancy JLC International.

Furthermore, the ethane market “is marked by long-term contracts, with little to no opportunity to resell cargoes on the spot market,” Rystad said April 10, making it tough for the Chinese to obtain alternative supplies from non-US sources.

While China has so far avoid widespread closures of production across sectors, it appears likely that the plastics industry in general, and the ethane and propane supply chains in particular, will be among those hit first and hardest. So for those seeking to time the moment of max pain, and greatest malleability of Beijing, keep an eye on Chinese plastic prices and/or labor strikes in the region.

The lower the former goes, the higher the latter will move, and the faster the trade war will come to an end. And come to an end it will, because as even Goldman forecast in its latest China forecast (available to pro subs here), the country's GDP is about to fall off a cliff: the bank now expects China's Q2 GDP growth to crater to just 0.8% QoQ from 4.9% in Q1. And that's just the start, if China is unable to unleash a stimulus similar in size to what it did during covid.

https://www.zerohedge.com/markets/chinese-plastics-factories-face-mass-closure-us-ethane-disappears

Women Don't Want AI as Sole Reader of Breast Cancer Screenings

 

  • Less that 5% of survey respondents accepted the idea of stand-alone mammogram AI interpretation, while 71% supported AI as a second reader.
  • About three-quarters of patients had minimal or no knowledge of AI.
  • Patient race and education level were significantly associated with acceptance of AI.

Few women wanted artificial intelligence (AI) as the sole reader of their screening mammograms, according to a survey, though most respondents generally supported some use of the technology.

Among more than 500 women who presented for a screening mammography during a 6-month period in 2023, just 4% of survey respondents accepted the idea of stand-alone AI interpretation, whereas 71% were comfortable with AI as a second reader, reported Basak Dogan, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues.

However, most patients reported that they had little or no knowledge of AI.

"Although there is an acceptance of AI, especially when used alongside a radiologist, there remain important concerns about its efficacy, potential bias, and the implications for patient-doctor interactions," they wrote in Radiology: Imaging Canceropens in a new tab or window. "As AI technology advances, it is necessary to continue engaging with patients to understand their evolving views and address any concernsopens in a new tab or window through education, transparency, and robust AI validation processes."

Overall, 518 patients who underwent screening at the University of Texas Southwestern Medical Center responded to the 29-question survey.

Most respondents (73%) were ages 40 to 69, two-thirds had attained college-level education or higher, and about half identified as non-Hispanic white. The vast majority (81%) of participants spoke English as their primary language, and 43% had a yearly income of more than $100,000.

Of the participants, 29% were premenopausal, 27% had at least one first-degree relative with breast cancer, 5% were previously diagnosed with breast cancer, 36% reported abnormal mammography results, and 23% had undergone a breast biopsy.

The survey showed that most patients reported they had minimal or no knowledge of AI, with 44% reporting they know "a little bit" about AI and 32% having no knowledge of AI.

About three-quarters of respondents (74%) said they believed consent was necessary before using AI for mammogram interpretationopens in a new tab or window. Participants with a yearly income exceeding $99,000 were less likely to consider permission necessary compared with those with a lower income.

When assessing AI's efficacy compared with radiologistsopens in a new tab or window, 5% believed AI to be "much worse," 21% said "worse," 43% said "same," 14% said "better," and 1% said "much better." There was no difference in the perception of AI's diagnostic accuracy versus a radiologist's based on respondents' age, race and ethnicity, educational attainment, or menopausal status.

Participants were approximately two times more likely to agree with AI usage in reading their mammogram if they had more than a college degree (OR 2.05, 95% CI 1.31-3.20, P=0.002) or a higher knowledge about AI (OR 2.31, 95% CI 1.51-3.53, P<0.001).

Concerning data privacy, 30% of surveyed individuals expressed moderate concern, and 36% were very or extremely concerned.

However, concerns about data privacy and potential AI biases were significantly higher among participants who were Hispanic (ORs of 2.41 and 3.32, respectively) and non-Hispanic Black (ORs of 2.87 and 4.31).

In addition, compared with non-Hispanic white participants, non-Hispanic Black participants were less likely to agree with the use of AI (OR 0.38, 95% CI 0.22-0.65, P=0.005).

"Our findings highlight the critical need to address racial and ethnic disparities within AI healthcare applications, revealing that participants, like researchers, are concerned about potential biases," the study authors observed.

The authors acknowledged several limitations to the study, including the fact that the survey was conducted at an academic center where most patients were covered by private insurance. Attitudes toward AI could vary depending on access to insurance and healthcare accessibility.

Additionally, Dogan and colleagues noted that AI is an inherently complex subject and that respondents might not fully have understood the concept, which could have influenced survey responses.

"However, we believe that the responses we obtained reflect patients' opinions in the absence of detailed prior knowledge, thus capturing perspectives representative of the general public," they said.

Disclosures

Dogan reported relationships with the NCI/NIH, Bracco Medical, Cancer Prevention Institute of Texas, Elsevier, Seno Medical, Massachusetts General Brigham Women's Hospital, and Mount Sinai Icahn Medical School, and for a patent related to predicting breast cancer metastasis.

Primary Source

Radiology: Imaging Cancer

Source Reference: opens in a new tab or windowOzcan BB, et al "Patient perception of artificial intelligence use in interpretation of screening mammograms: A survey study" Radiol Imaging Cancer 2025; DOI: 10.1148/rycan.240290.


https://www.medpagetoday.com/radiology/diagnosticradiology/115213

'More Pharmacies Offer to Speed Prescription Deliveries to Customers'

 America's two largest retailers want to deliver prescriptions to your doorstep in as little as a few hours.

Amazon and Walmart are undergoing national expansions in same-day prescription deliveries. They're joining a trend that has gained momentum since the COVID-19opens in a new tab or window pandemic, with drugstore chains and companies like Instacart and DoorDash rushing to deliver prescriptions as soon as possible.

Fast prescription delivery options are growing as traditional drugstores closeopens in a new tab or window and more people use telemedicineopens in a new tab or window or subscription-based careopens in a new tab or window that encourages regular deliveries.

But this trend may run into limits in the complicated U.S. healthcare system, where drug costs and coverage can outweigh convenience for consumers, some of whom still like visiting a store.

"It takes a lot to change people's behavior when it comes to their healthcare," said Arielle Trzcinski, a principal analyst with the consulting firm Forrester.

Who Can Deliver My Prescriptions?

Independent drugstores have done same-day deliveries for years, especially for patients who are homebound or recovering from surgeries, said Brigid Groves, PharmD, a vice president with the American Pharmacists Association.

CVS Health started same-day deliveries in 2017 and has since expanded its reach. The chain delivered more than 4 million prescriptions through that service in 2023.

Walgreens also does this nationally and offers a service at hundreds of locations that will deliver within 2 hours.

Instacart got into prescription deliveries during the COVID-19 pandemic when it started a partnership with Costco. The grocery delivery company has since launched same-day delivery partnerships with Wegmans and Publix.

How Are Amazon and Walmart Expanding?

Amazon expects to offer same-day prescription deliveries to nearly half of its U.S. customers by the end of this year. It's adding 20 small pharmacies to distribution centers around the country to improve delivery speeds.

Separately, the company also has opened 10 prescription processing centers in the past few years. It can do same-day deliveries from those as well.

"We're building a modern pharmacy, what we like to think of as a pharmacy in your pocket," Amazon executive Hannah McClellan said at a company presentation last fall.

The Amazon Pharmacy vice president added that this included rapid deliveries and around-the-clock access to pharmacists.

Walmart launched same-day deliveries last fall in six states and expanded earlier this year to every state except North Dakota, where it has no pharmacies. The company allows customers to get their medicines along with groceries or other store items.

It offers several levels of service, including some deliveries in a half hour.

Why the Need for Speed?

Customer demand drove Walmart's expansion, said Kevin Host, PharmD, a pharmacy senior vice president. He said prescription deliveries were the top thing customers requested when surveyed by the company.

Host noted that most people pick a pharmacy based on how close it is to their home or whether it has a drive-through window.

"This is just elevating that level of convenience," he said.

Same-day deliveries can help people get started quicker on antibiotics or COVID-19 treatments when they are sick and see a doctor via telemedicine.

McClellan also said that customers who get their prescriptions quickly are more likely to take them. She said Amazon was doubling down on same-day deliveries this year and has "big plans to continue to build and scale those capabilities in the years to come."

What Might Hold Some People Back?

Patients may like convenience, but they like saving money even more.

Same-day deliveries can come with additional fees. People who consider them will want to know whether they are getting a better deal on their medicines, Trzcinski said. She noted that this is especially true with so-called maintenance prescriptions that are refilled repeatedly.

People with insurance who are taking those maintenance drugs may already have them delivered, noted Andrew Mulcahy, PhD, a senior health economist with the nonprofit research organization RAND Corp.

"The practical implications of these kinds of programs will be very muted," he said.

Customers also will have to trust that their regular prescriptions get delivered on time and are covered by their health insurer, especially if they switch pharmacies for deliveries. Some pharmacy benefit managers limit coverage outside certain pharmacies.

Drugstore pharmacists also have started providing more care and working with customers to manage conditions like high blood pressure. These things give people more reasons to visit a store.

Plus, some people just prefer going to drugstores. Don Watson says he might consider prescription deliveries "maybe 10 years from now when I'm not able to do it myself."

The 72-year-old Indianapolis resident said as he left a Walgreens store recently that he has no problem picking up prescriptions.

"Sometimes the wait can be a little long ... that's my only gripe," he said.

https://www.medpagetoday.com/pharmacy/pharmacy/115215

'Ob/Gyns Mostly Stayed Put After SCOTUS Overturned Roe, Study Finds'

 

  • There was no population-level ob/gyn exodus away from abortion-restrictive states post-Roe.
  • Ties to patients and local community and the significant effort and disruption associated with relocation may be at play.
  • Residency trends may be a more apt assessment of abortion bans' influence on workforce trends.

In the post-Roe v. Wade era, ob/gyns continued to practice in similar locations as before, according to a descriptive cohort study.

From the quarter right before the June 2022 Dobbs v. Jackson Women's Health Organization decision through the end of the study in September 2024, 95.8% of ob/gyns remained in states that protect access to abortion, 94.8% remained in states threatening bans, and 94.2% remained in states with abortion bans, reported Becky Staiger, PhD, of the University of California Berkeley, and colleagues.

In this sample of 60,085 ob/gyns, the mean increase in the per-quarter number of ob/gyns from before to after Dobbs was 8.3% in states with total abortion bans, 10.5% in states with gestational age limits or threatened abortion bans, and 7.7% in states with abortion protections, they noted in JAMA Network Openopens in a new tab or window.

"The only statistically significant difference suggested that the share of physicians who are ob/gyns decreased less in threatened states than in protected ones, opposite to the expected finding if ob/gyns were leaving states where abortion is threatened," the authors wrote.

They also found that there were "no appreciable differences among recent ob/gyn residency graduates in the likelihood of moving to total ban states," nor differences by subspecialty or gender.

"These results may suggest that concerns prompting ob/gyns to consider relocation are thus far being offset by other forces, such as ties to patients and local community and the significant effort and disruption associated with relocation," Staiger and team wrote.

They did note that while trends in the number of ob/gyns in each type of state did not meaningfully differ after Dobbs, this study doesn't speak to "the evolution of other aspects of reproductive healthcare" -- like quality of care, practitioners' moral distress, or quality of ob/gyn training.

"Although these findings do not provide insight into changes in the quality of care provided, they suggest that there are no major changes in the supply of ob/gyns associated with the Dobbs decision," they concluded.

In an invited commentaryopens in a new tab or window, Blair Darney, PhD, MPH, of Oregon Health & Science University in Portland, and co-authors argued that residency training is "the central inflection point to track workforce impacts of abortion bans," because it is not an open job market and because residency location determines ob/gyn training on critical skills like abortion and miscarriage management.

Past research has shown that access to abortion trainingopens in a new tab or window is important to ob/gyn residency applicants and that states with abortion bans saw a small decline in the numbers of ob/gyn residency applicationsopens in a new tab or window. Still, ob/gyn residency slots in abortion-restrictive states still get filled because "there are applicants who would prefer training in a ban state to not training at all," Darney and colleagues wrote.

They noted that some programs in abortion-restrictive states have found ways to connect their trainees with programs in other states to learn abortion procedures, though much of the onus and cost falls on the resident -- not their residency program -- and there are still legal and logistical challenges to doing this.

"This resident-driven approach exacerbates disparities in technical skill between residents and programs with resources and institutional support to travel out-of-state and those without," they pointed out.

Darney and team recommended that future research on "the workforce impacts of abortion bans should consider trainees earlier in their careers, [complex family planning] subspecialists, and differentiate the nuances of abortion bans."

For this study, Staiger and colleagues identified all practicing ob/gyns within the National Plan and Provider Enumeration System (NPPES), a registry of healthcare practitioners in the U.S., from January 2018 through September 2024.

Of the 60,085 ob/gyns included in the sample, 59.7% were women, 12.9% were recent residency graduates, and 3.8% were maternal-fetal medicine specialists.

State abortion policies were assigned as either total ban, threatened states with gestational bans, and protected states unlikely to enact an abortion ban.

At the time of analysis, 14 states had total bans (Alabama, Arkansas, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and West Virginia), and 11 were considered threatened states (Arizona, Florida, Georgia, Iowa, North Carolina, Nebraska, Ohio, South Carolina, Utah, Wisconsin, and Wyoming); the rest had abortion protections.

In terms of limitations, the authors noted that the study only looked at the 2 years post-Dobbs, which only captures short-term changes in physician behavior. They didn't have access to physician characteristics like political party affiliation that may impact their choice to move or stay put. Even though NPPES has verified locations for physicians that bill to public or private insurance, it's still possible that some error exists, though there is no evidence it would impact the results in a significant way.

Disclosures

Staiger had no disclosures.

Co-authors reported receiving personal fees from the Planned Parenthood Federation of America, the Center for Reproductive Rights, the U.S. Congressional Budget Office, the Urban Institute, and the Society of Family Planning.

Darney reported grants from the NIH and personal fees from the Society of Family Planning, Contraception, and the American College of Obstetricians and Gynecologists.

Other editorialists reported grants from the NIH, the Society of Family Planning, the Lalor Foundation, and the Collins Foundation.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowStaiger B, et al "Obstetrician and gynecologist physicians' practice locations before and after the Dobbs decision" JAMA Netw Open 2025; DOI: 10.1001/jamanetworkopen.2025.1608.

Secondary Source

JAMA Network Open

Source Reference: opens in a new tab or windowLiberty A, et al "How should we study and interpret workforce impacts of abortion restrictions?" JAMA Netw Open 2025; DOI: 10.1001/jamanetworkopen.2025.6136.


https://www.medpagetoday.com/obgyn/abortion/115212

SCOTUS Gives Mixed Signals on ACA's Preventive Care Coverage Mandate

 The word "independence" was heavily featured in Monday's oral argument

opens in a new tab or window before the Supreme Court on a case questioning the legitimacy of the Affordable Care Act (ACA) requirement that insurers cover certain preventive services free of charge to patients.

"That's an incredibly strained interpretation of the term 'independent,'" Justice Samuel Alito said to Principal Deputy Solicitor General Hashim Mooppan, who had just made an argument on behalf of the federal government. "Explain to me how somebody can be independent and yet subject to removal [from their position] on the whim of the president."

"It's 'independent' in the sense that they have both the duty and power to exercise their own best judgment," Mooppan said. "That doesn't mean that once they've done so, they're free from accountability. It just means that when they are making the decision, they have an obligation to exercise their best scientific judgment."

How Independent is the U.S. Preventive Services Task Force (USPSTF)?

Alito and Mooppan were referring to the independence -- or not -- of the members of the USPSTF, the body at the heart of the discussion. The case, known as Kennedy v. Braidwoodopens in a new tab or window, involves Christian-owned businesses and six individuals in Texas who have challenged the ACA requirement to cover preventive services, according to an issue briefopens in a new tab or window from KFF, a health policy research and news organization. In particular, the court is considering whether the structure of the USPSTF -- an entity convened by the federal government that makes recommendations for preventive services -- violates the U.S. Constitution's Appointments Clause.

Under the Appointments Clause, "officers of the United States" may only be appointed by the president, subject to Senate approval. The plaintiffs argue that the USPSTF is unconstitutional because its members are not presidentially appointed or Senate-confirmed. This is relevant because the ACA requires all insurers -- including private insurers and self-insured employers such as those in the lawsuit -- to cover at no charge any preventive services that are recommended by the USPSTF (including among other care screenings for breast, colon, prostate, and lung cancers; depression; diabetes; obesity; and sexually transmitted infections).

Some of the discussion revolved around just how independent the task force was and who had the power to remove its members. Justice Ketanji Brown Jackson asked Mooppan to opine on why he thought his understanding of the task force's independence was a better one than the opposition's.

"This court obviously reads statutes to avoid constitutional problems, rather than create them," Mooppan replied. "So you shouldn't read the phrase 'independent' to impose a removal restriction that's not there, to impose a bar on review that's not there, or to impose restrictions on who can appoint that aren't there. You should read [that] the statute reinforces that the secretary has adequate supervision, so that the statute as written by Congress can continue to operate."

A Matter of Language

Justice Clarence Thomas noted that Jonathan Mitchell, the attorney for the plaintiffs, had a much broader view of the task force's independence than Mooppan did, and asked Mitchell to address that.

"Well, there are two different words in play here," said Mitchell. "It's not just the word 'independent,' which appears in [two parts of the law]. It's also the phrase in [another section of the law] that says the task force is to be protected from political pressure to the extent practicable. And we don't see any way that statutory language can be squared with the regime envisioned by the government, where the secretary can come in and influence the task force decisions on the front end."

Justice Elena Kagan took issue with Mitchell's interpretation. "It does seem that your argument really does rise and fall on how we read that 'independence' language," she said. "And, you know, just an alternative view of that language is something along the lines of: Look, the members of this task force are going to be subject to some kinds of influence because somebody can remove them and also because they're subject to supervision. But we want them to approach their jobs with a spirit of independent-ness."

"Also Congress is saying to the people who do supervise and who have discharge powers over them: 'You too should think about the fact that this system works best if the task force members are treated as independent,' but it's not saying that nobody can fire them," she continued. "It's not saying that nobody can supervise them and nobody can prevent their recommendations from going forward. It's hortatory. So why shouldn't I read the statute that way?"

On another front, Justice Thomas asked Mooppan about the role of the Reorganization Act of 1949, which allows the president to reorganize the federal government. "The Reorganization Act is a way to confirm that the [HHS] secretary has the direct appointment authority with respect to the task force members," said Mooppan.

"I thought the reorganization dealt with agencies within HHS," said Thomas. "Is the task force an agency?"

"There's not anything that says they are or aren't, but I think the clear best reading of the statute is, when you have an entity that's convened by the Public Health Service, selected by the Public Health Service, supervised by the Public Health Service, and supported by the Public Health Service, it's part of the Public Health Service," Mooppan said.

Justice Brett Kavanaugh seemed somewhat skeptical of Mitchell's arguments. "Your theory, I think, depends on us treating the task force as this massively important agency that operates with unreviewable authority to make really critical decisions that are going to affect the economy, and without any supervision or direction by the secretary," he said. "And, normally, before that kind of thing would happen, Congress would have provided stronger indications that this task force is enormously important in the American economy and would have treated it such. And I just don't see indications of that."

A Mixed Bag

How did the justices appear to be leaning on the case? It was hard to say, according to several experts. "It was very hard to read," said Laurie Sobel, associate director for women's health policy at KFF and one of the co-authors of the organization's brief. "There seem to be enough justices who seem to think that the word 'independent' doesn't mean 'without any oversight of the agency,'" a view that would seem to support the Trump administration's argument that oversight was adequate.

Andrew Twinamatsiko, a director of the Center for Health Policy and the Law at Georgetown University in Washington, D.C., also thought the justices' comments were a mixed bag. "This is a really important health policy that the challengers are trying to kill with technicalities, and there isn't really clarity on where the justices are going to go," he said.

"The technical nature of the case obfuscates what's at stake -- a very popular provision of the ACA, which has tremendous use of preventive services that have averted premature death and [decreased] morbidity and mortality rates," he added. The fact that the plaintiffs' argument is based on a technical question about the independent nature of the task force members "is really telling on how this argument isn't about accountability, but is another strategy to upend the signature legislation health policy in a generation."

Katie Keith, also a director at the Center for Health Policy and the Law, noted in an email that "several of the justices seemed troubled by what Justice [Amy Coney] Barrett referred to as Braidwood Management's 'maximalist' view that the secretary has no role to play."

Andrew Pincus, an attorney at Mayer Brown in Washington, D.C. who wrote a "friend of the court" briefopens in a new tab or window on behalf of several groups supporting the administration's position, had a different take. "It seems to me that a number of the justices were very open -- if not seemingly possibly supportive -- of the Trump and Biden administrations' position that the statute can and should be interpreted to give the secretary enough control over whether the recommendations can become binding on private parties to satisfy the Constitution, and therefore there was no need to invalidate it."

"If the concern is, we need somebody appointed by the president and confirmed by the Senate to make these decisions -- or at least to be overseeing these decisions -- the answer is, we've got that, and that should solve any constitutional problem," he added.

A decision on the case is expected in June.

https://www.medpagetoday.com/publichealthpolicy/publichealth/115218