Weekend update

Mental health care

Weekend update

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care–
  • From Washington, DC
  • The Wall Street Journal reports,
    • “The Senate geared up Sunday for an all-night session of debate and amendment votes on the GOP’s “big, beautiful bill” [HR 1], after Republicans narrowly advanced the measure in a 51-49 vote that set up more push-and-pull before final passage.
    • “The 940-page legislation is driving a wedge between the GOP’s two wings, just as the party is racing to pass the measure early this week. Centrists have raised concerns about cutting benefit programs and straining state budgets, while fiscal conservatives are pushing for even more cuts to rein in federal budget deficits. 
    • “Proponents maintain that the opportunity to pass President Trump’s core agenda items—and pressure from Trump on holdouts—would propel the package over the finish line in the Senate, where the GOP has a 53-47 majority. 
    • “It’s a big, beautiful bill if you believe in cutting people’s taxes, securing the border, having a strong military and controlling government spending,” Sen. Lindsey Graham (R., S.C.) said on the Senate floor Sunday. “The bottom line is, we’re about to make history,” he said.”
  • Here’s a link to the Journal’s explanation of the key provisions in the bill under Senate consideration. The Senate press gallery notes “The Senate will convene on Monday at 9:00 a.m. and begin the Vote-A-Rama on H.R. 1.” If the Senate passes the bill, then the Senate bill, which is based on the bill that the House passed in May, will go back to House for a vote. If the House approves the bill, then the bill will go to the President for signature into law.
  • Beckers Payer Issues calls attention to five Medicare Advantage bills pending in Congress.
  • The Wall Street Journal lets us know how “the Supreme Court dipped its toes into Trump 2.0” during its October 2024 term ended last Friday.

From the public health and medical research front,

  • Fortune Well reports,
    • For all of the advancement in treating stroke victims over the past couple of decades, some concerns have remained almost constant. In medicine, we like to say that “time is brain,” meaning that every moment a stroke goes untreated, the potential for long-term brain damage or death escalates. In fact, every minute that the brain goes without blood flow, the average patient loses around 1.9 million neurons and about a week of independent life, experts say.
    • “As the vast majority of strokes are ischemic, with a blood clot blocking the flow of oxygen to the brain, clearing that clot swiftly is critical. This is true whether the clot is small or large and regardless of its density—but reliably removing the densest clots via mechanical means has proved an elusive task.
    • “Though these concerns, time and density, are not necessarily linked, both matter—one reason, researchers suggest, that a newly developed technology from Stanford University holds the potential to reshape how stroke patients are treated.
    • “The device, called a milli-spinner, is a tiny, powerfully rotating hollow tube outfitted with fins and slits. In action, both lab and swine tests demonstrate the ability to dramatically compact and shrink the size of blood clots, making it easier to remove them quickly and effectively—often on the first try.
    • “This has the potential to be a game changer,” says Greg Albers, director of the Stanford University Stroke Center and a longtime expert in the field. “The results are likely to translate well to clinical trials.”
  • The New York Times tells us,
    • “Gary Sergott felt weary all the time. “I’d get tired, short of breath, a sort of malaise,” he said. He was cold even on warm days and looked pale with dark circles under his eyes.
    • “His malady was not mysterious. As a retired nurse-anesthetist, Mr. Sergott knew he had anemia, a deficiency of red blood cells. In his case, it was the consequence of a hereditary condition that caused almost daily nosebleeds and depleted his hemoglobin, the protein in red blood cells that delivers oxygen throughout the body.
    • “But in consulting doctors about his fatigue, he found that many didn’t know how to help. They advised Mr. Sergott, who lives in Westminster, Md., to take iron tablets, usually the first-line treatment for anemia.
    • “But like many older people, he found a daily regimen of four to six tablets hard to tolerate. Some patients taking iron complain of severe constipation or stomach cramps. Mr. Sergott felt “nauseated all the time.” And iron tablets don’t always work.
    • “After almost 15 years, he found a solution. Dr. Michael Auerbach, a hematologist and an oncologist who is the co-director of the Center for Cancer and Blood Disorders in Baltimore, suggested that Mr. Sergott receive iron intravenously instead of orally.
    • ‘Now Mr. Sergott, 78, gets an hourlong infusion when his hemoglobin levels and other markers show that he needs one, usually three times a year. “It’s like filling the gas tank,” he said. His symptoms recede, and “I feel great.”
    • “His story reflects, however, the frequent dismissal of a common condition, one that cannot only diminish older adults’ quality of life but lead to serious health consequences, including falls, fractures and hospital stays.”
  • The Washington Post informs us,
    • In her mid 70s, Argie, a widowed former teacher, began feeling poorly. She was tired. Her stomach hurt. Sometimes she got agitated. And she seemed forgetful.
    • Worried, her grown children urged the woman, who asked that only her first name be used for privacy reasons, to consult a memory specialist in Baltimore, not far from her home.
    • Argie’s cognitive powers, the doctor concluded, were reasonably good. But her medicine cabinet was a real hazard: She was taking 21 different prescription drugs, for diabetes, high blood pressure and her kidneys. After an assessment by a team that included a clinical pharmacy specialist well versed in drug interactions, she’s now down to eight.
    • “Every time I went in to a doctor, they gave me another pill,” Argie said. She’s now less confused. Less agitated. Less nauseated. She said cognitive challenges are manageable, and she’s more energetic and steadier on her feet.
    • “That overload of drugs, known as polypharmacy, can be dangerous at any age but it’s particularly hazardous for elderly people, who often have multiple health conditions and whose bodies may not handle meds the same way they did when they were younger, said Nicole Brandt, a leading expert on geriatric prescribing at the University of Maryland.”
  • Per Medscape,
    • “Posttraumatic headache (PTH) is frequently misdiagnosed and undertreated in nonspecialist settings, highlighting a critical gap in diagnostic accuracy, treatment access, and integrated care for this complex condition, new research showed. 
    • “Investigators found that patients with the condition are frequently misdiagnosed and undertreated in nonspecialist settings. Further, most are only correctly diagnosed with a migraine phenotype after evaluation by a headache specialist.
    • “A central message of our work is that the diagnosis of ‘headache’ is too often treated as a monolith — an endpoint rather than the beginning of a diagnostic journey,” study investigator Natalia Murinova, MD, clinical professor of neurology, and director of the headache clinic at the University of Washington (UW), Seattle, told Medscape Medical News.
    • “The results of the retrospective analysis were presented at the American Headache Society (AHS) Annual Meeting 2025.”

Weekend update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Senate maintains a daily Executive Calendar. There are now eight nominees whose names were reported to the Senate floor before Scott Kupor. According to the unanimous consent resolution page in the front of the calendar, the Senate will consider tomorrow the nominations of the earliest reported nominee David Fotouhi (March 13) and two nominees reported in May after Mr. Kupor (April 9). The FEHBlog think that this is the pattern that the Senate leadership is following, which means that the Senate is likely to take up Mr. Kupor’s nomination later this month. 
  • Roll Call summarizes expected Congressional activities for this week here.
    • As Senate committees continue to release their proposals for the House-passed reconciliation package this week, the House plans to vote on President Donald Trump’s proposals to rescind foreign aid and other spending, including for public broadcasting.
    • “The rescissions request sent to Congress by the Trump Administration takes the federal government in a new direction where we actually cut waste, fraud, and abuse and hold agencies accountable to the American people,” House Majority Leader Steve Scalise, R-La., said in a statement.
  • The Supreme Court will be issuing another batch of opinions this coming Thursday.
  • Last Thursday, HR Dive tells us,
    • “A federal appeals court’s “background circumstances” requirement for majority-group plaintiffs who seek to prove job discrimination cuts against both Title VII of the 1964 Civil Rights Act and U.S. Supreme Court precedent, Justice Ketanji Brown Jackson wrote for a unanimous SCOTUS on Thursday.
    • “The court reversed the 6th U.S. Circuit Court of Appeals’ decision in Ames v. Ohio Department of Youth Services, which had dismissed a heterosexual woman’s claim that she was unlawfully passed over for a promotion in favor of a lesbian woman and subsequently demoted, after which a gay man was hired to fill her original role. The plaintiff alleged that those decisions constituted illegal discrimination on the basis of her sexual orientation, which the Supreme Court has said is a form of sex-based discrimination under Title VII.
    • “The 6th Circuit held that the plaintiff could not show background circumstances to support her suspicion that her employer discriminated against her on the basis of her status as a member of a majority group.
    • “Justice Jackson, however, wrote that such requirements flout the Supreme Court’s case law, which “makes clear that the standard for proving disparate treatment under Title VII does not vary based on whether or not the plaintiff is a member of a majority group.”
    • “The court vacated and remanded the case to the 6th Circuit for further proceedings.”
  • Federal News Network interviews Tammy Flanagan about “what retiring feds need to know about their benefits in transition.”
    • “Timing is everything when thinking about when to drop your retirement paperwork. Understanding what happens to your leave balances, health insurance, and survivor benefits can inform that decision. Hear with more on those key considerations is the Founder and Principal Retirement specialist at Retire Federal, Tammy Flanagan.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “A new gene-tracking study in Nature shows that mpox spread among people in Nigeria for 8 years before it sparked a global outbreak in 2022.
    • “Using genomic tracing, researchers from Nigeria, the United States, Cameroon, Ethiopia, and Belgium estimate that the ancestor of the clade 2 mpox virus (mpxv) that ignited an international outbreak beginning in May 2022 first emerged in southern Nigeria in August 2014 and spread to 11 Nigerian states before human infections were detected in 2017. 
    • “In light of the findings, the authors write, “We need improved surveillance in the wildlife population in the forest systems to better understand the transmission and maintenance of MPXV in animal hosts,” as well as better human surveillance.
    • “We could have very easily prevented the 2022 multi-country outbreak if countries in Africa were given better access to therapeutics, vaccines, and surveillance technologies,” says first author Edyth Parker, PhD, MPhil, a researcher with the Institute of Genomics and Global Health and with the International Biosecurity and Biosafety Initiative for Science, in a Scripps Research news release. “In a vulnerably connected world, we cannot neglect epidemics until they get exported to the Global North.”
  • Medscape offers these reports from the recent American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • Changing the prescribing protocol for low-dose aspirin (LDA) for preeclampsia prevention from risk-based to universal significantly increased aspirin use in pregnant patients, based on new data presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • The use of LDA to reduce the risk for preeclampsia has been well established as an inexpensive and simple intervention, but it has remained underutilized nationwide, said lead author Meryl Y. Grimaldi, MD, of SBH Health System, New York City, in an interview.
    • “Many of the patients we care for at SBH Health are at high risk for preeclampsia, but we wanted to ensure that our eligible patients received the benefits of this intervention,” said Grimaldi, who presented the study at the meeting.
  • and
    • “Clinicians need to discuss and offer all patients a variety of pain management options for in-office gynecologic procedures ranging from intrauterine device (IUD) insertion to biopsies, according to new guidance published by the American College of Obstetricians and Gynecologists (ACOG). The guidelines, published on May 15, are the first formal ones from ACOG to not only acknowledge the range of pain experiences that can be associated with different procedures but also to explicitly lay out recommendations for the conversations providers should have with their patients about what pain management options are available.
    • “This guidance speaks to more than just Ob/Gyns,” Co-Author Genevieve Hofmann, DNP, women’s health nurse practitioner and assistant professor of Ob/Gyn at the University of Colorado School of Medicine in Aurora, Colorado, said during a discussion with the press on May 17 at American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Minneapolis. “It speaks to any physician who’s providing these types of services and certainly to advanced practice registered nurses who work in women’s health and provide these services.”
  • Medscape adds,
    • Regeneron said on Monday [June 2, 2025,] its experimental drug helped patients preserve up to 51% of lean mass and lose more fat when used in combination with Novo Nordisk’s popular obesity drug Wegovy in a mid-stage trial. 
    • In the 599-patient study, those on Wegovy alone lost about 7.9 pounds of muscle, while those on a combination of Regeneron’s trevogrumab and Wegovy lost up to 4.2 pounds. 
    • The combination helped patients shed up to 11.3% of their body weight compared with 10.4% for those on only Wegovy. 
    • The results mark an early win for Regeneron in the race against nearly a dozen companies to develop obesity treatments that preserve muscle, as they vie for a share of the potential $150 billion weight-loss drug market. 

From the U.S. healthcare business front,

  • Medical Economics “spoke with Mark McClellan, M.D., Ph.D., director, Duke-Margolis Institute for Health Policy, and a former administrator at CMS, about why value-based care hasn’t been adopted more quickly.” and let us know that “New Marit Health data from May, 2025, reveal that physicians feel most satisfied where compensation aligns with cost of living, practice expectations and quality of life. These 10 states show that perceived fairness matters just as much as raw earnings.”
  • The Wall Street Journal reports,
    • Unexpected healthcare costs can arise in retirement, such as uncovered drugs, isolation and concierge care.
    • Medicare Part D may not cover all drugs, potentially leading to high out-of-pocket expenses for uncovered medications.
    • Retirees may face unexpected travel costs for medical care based on retirement location or feel compelled to pay for concierge medical care.
  • All PSHB plans and Most FEHB plans offer Medicare Part D plans which are integrated with the regular plan formulary, thereby reducing one of the Journal’s identified risks.
  • Per BioPharma Dive,
    • “Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals.
    • “One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlight at the American Society of Clinical Oncology’s annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.
    • “Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyo’s developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plansto have these five “ADCs” approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.
    • “We’d like to become one of the most important players in oncology,” said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. “Our senior leaders are now talking about not only top 10, but maybe top 5. We’re very much confident in our ADCs.”
  • Per Fierce Healthcare,
    • Neuroscience technology company Brooklyn Health is using artificial intelligence to target a fundamental problem in neurology and psychiatry: the flawed approach to mental health outcomes measurement.
    • The startup aims to modernize mental health measurement and scoring in central nervous system (CNS) drug development, an area of CNS research that faces limitations in objectivity and standardization. 
    • “Clinical interviews, the standard for symptom assessment, are fundamentally unreliable and imprecise,” said Anzar Abbas, Ph.D., a neuroscientist and founder of Brooklyn Health, in an interview.
    • “Brooklyn’s platform uses AI and digital phenotyping methods it developed to evaluate the quality and scoring of clinical interviews in real time.” * * *
    • “Brooklyn’s current focus in on drug development and central nervous system clinical trials to improve outcome measurement, essentially, how well a drug is working. But the company has ambitions beyond clinical trials to support outcome measurement across all forms of behavioral health delivery, including in-clinic psychiatric care and virtual mental health platforms.” 
  • The Washington Post reports on a smartphone app Death Clock AI that predicts how many years a user has left before beginning to push daisies as they day.

Friday report

David Ermer–AHRQ, CDC, Congress, COVID-19, Employee Wellness Programs, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News reports,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Andy Kim, D-N.J., June 5 reintroduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with continuing its efforts addressing sepsis care. The agency’s work would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, and developing and implementing a sepsis outcome measure.
    • “The bill would also require a report on a sepsis outcome measure and a congressional briefing on the CDC’s sepsis activities. Additionally, the legislation includes a voluntary recognition program for hospitals that maintain effective sepsis programs or improve their programs over time.”
  • and
    • “The House June 4 passed the AHA-supported SUPPORT Act (H.R. 2483) by a 366-57 vote. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder, including programs to support the behavioral health workforce.”
  • Federal News Network tells us,
    • “More federal employees filed retirement papers with the Office of Personnel Management in May than in the last three months. OPM said it received more than 15,000 claims last month, driving the backlog up over 21,000. The processing time for these retirement claims remain consistent at 49 days on average in May and 52 days on average for the entire 2025. The increase in applications comes as OPM is requiring agencies to send retirement paperwork only in digital formats by July 15. OPM launched two new tools this week to improve the retirement services process. One is a new platform for agency HR and payroll providers and another to modernize the Electronic Official Personnel Folder (eOPF) platform.”
  • CMS shared “Federal Independent Dispute Resolution (IDR) Technical Assistance for Certified IDR Entities and Disputing Parties –June 2025 — Topic: Errors Identified After Dispute Closure.”
  • BenefitFocus discusses “Health Care Transparency 2.0 – What Might We See in Forthcoming Transparency Regulations.”

From the Food and Drug Administration front,

  • Per BioPharma Dive, “FDA meeting gives window into gene therapy field’s angst. Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.”
  • Per MedTech Dive,
    • “Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. 
    • “The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
    • “Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.”
  • BioPharma Dive relates,
    • “Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera’s therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies’ Farzin Haque cautioned not to “overinterpret the data” and argued the two datasets “are not clinically or statistically different for commercial uptake.” The Food and Drug Administration could approve Otsuka’s drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter.”

From the judicial front,

  • Beckers Hospital Review informs us,
    • “The CEO of a healthcare software company was convicted by a federal jury for his role in operating a platform that generated fraudulent physicians’ orders to defraud Medicare and other payers out of more than $1 billion.
    • “Gary Cox, 79, of Maricopa County, Ariz., was the CEO of Power Mobility Doctor Rx (DMERx), an internet-based platform that generated fraudulent orders for unnecessary orthotic braces, pain creams and other items, according to a June 3 Justice Department news release.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The AHA News lets us know,
    • “There have been 1,168 confirmed cases of measles across 33 states as of June 6 this year, according to the latest data from the Centers for Disease Control and Prevention. This year’s figure is more than four times higher than the 2024 total of 285 cases. There have been 17 outbreaks this year, and 89% of confirmed cases (1,040 of 1,168) are outbreak-associated. The vaccination status of 95% of all cases is classified as “unvaccinated or unknown.” 
  • Of note, Health Day warns us,
    • “An afternoon snooze might seem appealing to middle-aged folks and seniors, but these naps could carry a high cost.
    • “People with certain types of napping patterns have a greater risk of an early death, researchers are slated to report at an upcoming meeting of the American Academy of Sleep Medicine (AASM).
    • “People who slept longer during the day, had irregular daytime sleep patterns, or slept more around midday and early afternoon were at greater risk, even after accounting for health and lifestyle factors,” lead researcher Chenlu Gao, a postdoctoral research fellow at Massachusetts General Hospital in Boston, said in a news release.
    • “The findings call into question the whole concept of the “power nap.”
  • HHS’s AHRQ posted a report about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • Per HR Dive,
    • “Work can either fuel employee well-being or become a source of strain for employees already stressed out by economic volatility and political tension, according to a May 12 survey of employee mental health by Inmar Intelligence.
    • “Of the 1,000 U.S. full- and part-time employees who responded to the May 12 survey, 34% said their job positively impacts their mental health, while 33% reported a negative impact, Inmar found.
    • “This near-even split reinforces the importance of thoughtful leadership and inclusive workplace design to support the full spectrum of employee needs,” the business technology firm stated in a May 29 post.”
  • Cardiovascular Business reports,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first robotic explant of a transcatheter aortic valve replacement (TAVR) device and subsequent aortic valve replacement.
    • “The group already has plenty of experience breaking new ground in the field of robotic-assisted surgery. They developed a robotic aortic valve replacement (RAVR) technique that is now being used all over the world and performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure in 2024.
    • “This latest breakthrough started when Thelma Hyer, a 67-year-old female patient, presented with a failing TAVR valve in addition a leaky mitral valve. She had received her TAVR valve just four years prior, but premature structural valve degeneration had already made a full replacement necessary.
    • “Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute, initially recommended open-heart surgery to remove the failing TAVR valve and then replace her aortic and mitral valves. However, Hyer and her family had hesitations due to her history of scoliosis and arthritis. Badhwar then proposed using robotics as an alternative. 
    • “The technology had never been used in this exact way before, but Badhwar was confident in the abilities of both his team and the robotic surgery platform. The group developed a plan, talked it over with the patient, and went forward with the robotic procedure in late May. 
    • “The operation—including the TAVR explant and the replacement of both heart valves—appears to have been a success. Hyer was discharged after less than a full week of observation.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Omada Health shares jumped after the company made its public-market debut, propelled by Americans’ renewed focus on how weight affects physical health.
    • “Shares of the virtual healthcare platform climbed 35% to $25 on Friday, at one point hitting a high of $28, above the initial offering price of $19. The price gives it a market valuation of around $1.4 billion.
    • “The gains are a sign investors are willing to invest in newly public companies after a volatile stock market pushed some companies like payments platform Klarna to delay its IPO filing. Stablecoin issuer Circle opened on Thursday at $69, more than double its offering price, and was recently trading at $119.15. Hinge Health HNGE 0.83%increase; green up pointing triangle, another digital health company, opened in May at $39 after offering a $32 price.
    • “Omada is trading publicly after 14 years of providing support to patients with weight-related chronic illnesses. Leadership sees the current moment as the perfect time for an IPO, as GLP-1 drugs such as Ozempic, Wegovy and Mounjaro have sparked renewed focus on health problems that can stem from obesity, President Wei-Li Shao said.
    • “We’re entering this unique moment in time where there’s a convergence between what we’ve been working on for over a decade, and then also what society is increasingly caring about,” Shao said.”
  • Becker Hospital Review discusses ten key transactions that created Ascension 2.0.
    • “Over the last 16 months, St. Louis-based Ascension has sold or consolidated about 35 hospitals across the country as it revamps its hospital portfolio, operating model and overall financial performance.
    • “Despite reporting a $466 million operating loss (a -2.4% margin) for the nine months ending March 31, 2025, the Catholic nonprofit system has made notable strides in improving its liquidity position. That progress is largely attributed to the successful collection of accounts receivable that had temporarily spiked due to two major cybersecurity incidents — the May 2024 ransomware attack and the February 2024 Change Healthcare cyberattack.
    • “Since the fourth quarter of fiscal 2024 — the three months ending June 30, 2024 — Ascension has improved recurring operating performance by $1.4 billion, while increasing patient volumes and same-facility revenue.”
  • Beckers Health IT tells us,
    • “California-based Stanford Health Care is piloting an internally developed, AI-backed software designed to revolutionize clinician interaction with the EHR.
    • “Nigam Shah, MBBS, PhD, chief data science officer at Stanford Health Care, is leading the development team for ChatEHR, which allows clinicians to ask questions, request summaries and pull specific information from a patient’s medical record. ChatEHR is built directly into Stanford’s EHR to maximize clinical workflow.
    • “The pilot is available to a small cohort of 33 physicians, nurses and physician assistants. The technology is secure and designed for information gathering; not medical advice.
    • “ChatEHR, which has been in development since 2023, facilitates a more streamlined and efficient way for clinicians to interact with patient records.
    • “This is a unique instance of integrating [large language model] capabilities directly into clinicians’ practice and workflow,” said Michael Pfeffer, MD, chief information and digital officer at Stanford Health Care and School of Medicine, in a news release. “We’re thrilled to bring this to the workforce at Stanford Health Care.”
  • Drug Store News informs us,
    • “Walmart has become the first retailer to scale its drone delivery to five states with its recently announced service expansion in Atlanta, Charlotte, Houston, Orlando and Tampa. The new service will launch at 100 stores throughout Arkansas, Florida, Georgia, North Carolina and Texas, in addition to current operations in Northwest Arkansas and the Dallas-Fort Worth area.
    • “As we look ahead, drone delivery will remain a key part of our commitment to redefining retail,” said Greg Cathey, SVP, Walmart U.S. transformation and innovation. “We’re pushing the boundaries of convenience to better serve our customers, making shopping faster and easier than ever before.”
    • “Continued Cathey: “This expansion of our drone delivery service marks a significant milestone in that journey. As the first retailer to scale drone delivery, Walmart is once again demonstrating its commitment to leveraging technology to enhance our delivery offerings with a focus on speed.” 

Thursday Report

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Senate Republicans are considering cuts to Medicare spending to help pay for Donald Trump’s signature legislative package.
    • “The GOP lawmakers are proceeding cautiously as they expand their search for savings to a popular health insurance program nearly all Americans rely upon in retirement, presenting the move as an effort to root out waste, fraud and abuse. That includes cutting payments to health insurance companies that run private Medicare plans.”
  • The Wall Street Journal adds,
    • “Humana, the second-biggest Medicare insurer, has told congressional staffers that it will support moves that would curtail billing practices worth billions in extra payments to the industry, according to staffers and a document viewed by The Wall Street Journal.
    • “The stance by a leader in the Medicare Advantage business—in which insurers offer privately run Medicare plans—represents an important development in a growing debate over how the companies are paid in the $460 billion program.
    • “Insurers get paid more for covering sicker patients in Medicare Advantage, giving companies an incentive to record more diagnoses. Humana has told congressional staffers that it is willing to back new limits on lucrative payments insurers can gain from diagnoses recorded by nurse practitioners who visit millions of enrollees in their homes, according to a one-page policy overview shared with congressional staffers.
    • “After the Journal published this article Thursday morning, the biggest Medicare insurer, UnitedHealth Group, posted a statement saying that it too would support a new limit on the use of diagnoses from home visits.”
  • Healio points out,
    • HHS has ended a government-funded program that distributed free COVID-19 tests to community organizations, a department spokesperson confirmed to Healio.
    • “With COVID-19 behaving more like the seasonal flu — rising and falling through the year — and tests widely available at retail stores nationwide, continued federal distribution is a significant waste of taxpayers’ dollars,” the spokesperson said. “The COVID-19 pandemic is over.” * * *
    • “The program differed from the mail-based program that was started and stopped several times throughout the pandemic and provided U.S. residents the opportunity to get free COVID-19 tests delivered directly to their homes.”
    • “HHS is in the process of purchasing a supply of tests that can distinguish between COVID-19 and influenza to have on hand for emergencies.”
  • Tammy Flanagan, writing in Govexec, discusses “Should you stay, or should you go? 10 tips for navigating your federal retirement decision. What to consider—financially and emotionally—before leaving government service.”

From the public health and medical research front,

  • Chief Healthcare Executive tells us,
    • Two years ago, the American Diabetes Association and The Leapfrog Group announced that they were joining forces to recognize hospitals for providing excellent care to patients with diabetes.
    • Now, the groups are announcing honors for a second batch of recipients, and they’re recognizing more than twice as many hospitals.
    • The American Diabetes Association and the Leapfrog Group have announced 36 hospitals as 2025 Recognized Leaders in Caring for People Living with Diabetes. A year ago, the groups recognized 17 hospitals [which are listed in the article].
    • The organizations say they want to give public recognition to hospitals, but they are also highlighting the importance of providing proper care for patients with diabetes.
    • Nearly one-third of patients admitted to hospitals (30%) are diagnosed with diabetes. Some of those are patients that are being treated in the hospital for another illness or injury.
  • The New York Times reports,
    • “The technology that powered Covid vaccines may also lead scientists to a cure for H.I.V. Using mRNA, Australian researchers said they were able to trick the virus to come out of hiding, a crucial step in ridding the body of it entirely.
    • “The research, published last week in Nature Communications, is still preliminary, and so far, has been shown to be successful only in a lab. But it suggests that mRNA has potential far beyond its use in vaccines as a means to deliver therapies against stubborn adversaries.
    • “Short for messenger RNA, mRNA is a set of instructions for a gene. In the case of Covid vaccines, the instructions were for a piece of the coronavirus. In the new study, they are for molecules key to targeting H.I.V.
    • “Dr. Sharon Lewin, director of the Cumming Global Center for Pandemic Therapeutics in Melbourne, who led the study, called mRNA a “miraculous” tool “to deliver things that you want into places that were not possible before.”
  • STAT News adds,
    • “People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications.
    • “The research, published Thursday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t. Participants, drawn from health records of nearly 140,000 patients in Canada, were matched for socioeconomic status and a long list of conditions in addition to diabetes.” * * *
    • “Seeing such a clear signal in our study was striking,” co-author Reut Shor of the University of Toronto told STAT. “The absolute risk remains low, but the advanced form of AMD is a condition with serious implications for vision and quality of life. So a doubling of risk is clinically meaningful, particularly for vulnerable populations like older adults who may already be at elevated baseline risk.”
  • Per Health Day,
    • “A quality improvement strategy can improve electronic health record-based screening for depression and anxiety in people with epilepsy, according to a study published online April 16 in the Journal of Clinical and Translational Science.
    • “Heidi M. Munger Clary, M.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues developed an implementation strategy for anxiety and depression screening among people treated at an epilepsy center. Implementation outcomes were evaluated five months postimplementation compared to two three-month preimplementation time frames.”
  • and
    • Dietary patterns seem to be associated with depressive symptoms, according to a study published online June 3 in BMJ Nutrition, Prevention & Health.
    • Gabriella Menniti, M.D., from Unity Health Toronto, and colleagues conducted a cross-sectional study using National Health and Nutrition Examination Survey 2007 to 2018 data to examine the association between restrictive dietary patterns and depressive symptoms stratified by sex and body mass index.
  • Per MedPage Today,
    • High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
    • Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
      • Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
      • Adults with diabetes not realizing it: 27.5% to 28.9%
      • Adults with high total cholesterol not realizing it: 11.5% to 11.9%
    • “Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events,” wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology“

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us,
    • “Nonprofit hospitals are seeing margins improve as patient demand for care soars, according to Kaufman Hall’s “National Hospital Flash Report” released June 5.
    • “Kaufman Hall, a Vizient company, analyzed data from 1,300 hospitals collected by Strata Decision Technology for its monthly report.
    • “Hospital performance from January to April outpaced the first four months of 2024, largely driven by patient volume and hospital efficiency,” said Erik Swanson, managing director and group leader, data and analytics, at Kaufman Hall. “Operating room minutes, ED visits and inpatient revenue are trending upward, demonstrating a strong demand for services. A decline in average length of stay indicates that hospitals are triaging, treating, and discharging patients effectively and appropriately.”
  • Modern Healthcare reports,
    • “Nineteen critical access hospitals in Nebraska have formed a clinically integrated network, the third coalition of its kind created over the past three months.
    • “The Nebraska High Value Network aims to give rural hospitals the scale to lower costs, invest in new technology, improve treatment and expand value-based contracts while remaining independent. The network, announced Thursday, follows similar alliances in Montana, Ohio, Minnesota and North Dakota.” * * *
    • “Cibolo Health, the rural health advisory firm that helped launch these hospital collaborations, will manage daily operations of the Nebraska High Value Network. The network will include clinical and business integration committees led by member hospital executives who will oversee quality and administrative initiatives.”
  • Beckers Clinical Leadership lets us know,
    • “The District of Columbia has the most physicians per 100,000 population, while Idaho has the fewest specialist physicians and Nevada has the fewest primary care physicians per 100,000, KFF data found.
    • “KFF used data from Redi-Data to find the number of MD and DO active state-licensed physicians as of April 2025. Becker’s used Census data from 2025 to find the population of each state.
    • “There are 535,542 primary care physicians and 570,655 specialist physicians in the U.S. this year.
    • “[The article includes a chart with] the number of primary care and specialist physicians per 100,000 people in each state and the District of Columbia.”
  • Per MedTech Dive,
    • “Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company’s expectation that it would suffer a $400 million tariff impact this year.
    • “Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
    • “Weeks before the pause, J&J had predicted on an April’s earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business.
    • “But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future.
    • “Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,” Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration’s Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs.
    • “In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity, emergency department visits, and laboratory percent positivity are at very low levels.
      • Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.

Thursday Report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare relates,
    • “A coalition of healthcare trade associations and companies representing 550 providers and accountable care organizations is pleading with Congress to restore incentive bonuses for Medicare alternative payment models.
    • “The American Medical Association, Boston-based Mass General Brigham and others wrote congressional leaders Thursday expressing concern that failure to renew bonus payments will worsen providers’ financial instability, particularly in underserved regions.
    • “While we have seen steady growth for advanced [alternative payment models] in recent years, 2025 is a pivotal year for Medicare’s value transformation,” the letter says. “The expiration of Medicare’s advanced [alternative payment model] incentive payments and sharp increase in qualifying thresholds is creating significant challenges for physician practices and hospitals as they plan for the years ahead.”
  • BioPharma Dive reports,
    • “The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain.
    • “Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company more than $700 million in total funding. Moderna also reported that an experimental H5 avian influenza vaccine it’s developed showed promising results in an early-stage clinical trial. But without the government’s help, it will now be forced to “explore alternatives for late-stage development and manufacturing.”
    • “While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis,” said CEO Stéphane Bancel, in a statement. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
  • Govexec tells us,
    • “Federal job applicants will soon be quizzed on their favorite Trump administration policy as part of the hiring process, according to the Office of Personnel Management’s new “merit hiring plan.”
    • “How would you help advance the president’s executive orders and policy priorities in this role?” asks one of four essay questions that job seekers must answer if they are seeking any federal position GS-5 or above. “Identify one or two relevant executive orders or policy initiatives that are significant to you, and explain how you would help implement them if hired.”
    • “The federal government’s dedicated HR agency published the plan via a joint memo from Vince Haley, director of President Trump’s Domestic Policy Council and acting OPM Director Charles Ezell. The document is a hodgepodge of bipartisan reforms developed under both Trump and former President Biden to accelerate and improve the hiring process, alongside plans to eradicate longstanding efforts to make the federal workforce more reflective of the American populace.”
  • Tammy Flanagan, writing in Govexec, discusses what the latest FERS changes found in the budget reconciliation bill mean for federal and postal employee retirement benefits.
  • The Congressional Budget Office announced its 2025 panel of health advisors.
  • STAT News informs us,
    • “The White House will fix errors in a much-anticipated federal government report spearheaded by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., which decried America’s food supply, pesticides and prescription drugs.
    • “Kennedy’s wide-ranging “Make America Healthy Again” report, released last week, cited hundreds of studies, but a closer look by the news organization NOTUS found that some of those studies did not actually exist.
    • “Asked about the report’s problems, White House press secretary Karoline Leavitt said the report will be updated.
    • “I understand there was some formatting issues with the MAHA report that are being addressed, and the report will be updated,” Leavitt told reporters during her briefing. “But it does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government.”
  • The International Foundation of Employee Benefits Plans discusses what the President’s April 15 executive order on PBM transparency means for employers and other purchasers of PBM services.
  • Per Fierce Pharma,
    • “Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).
    • “Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. 
    • “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.
    • “There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.”

From the judicial front,

  • Chain Drug Review reports,
    • “Express Scripts, a Cigna-owned pharmacy benefit manager, and CVS Health have filed separate lawsuits against the state of Arkansas, seeking to halt the implementation of a new law that would bar PBMs from owning, managing, or controlling pharmacies within the state. 
    • “In a statement, CVS Health said the “unconstitutional law puts local politics ahead of patients, restricting their access to life-saving medications and undermining fair competition.“
    • “The lawsuits, filed Thursday in the U.S. District Court for the Eastern District of Arkansas, argue that the law, scheduled to take effect in 2026, is unconstitutional under multiple provisions, according to Modern Healthcare. Both companies claim the legislation would lead to significant disruptions in pharmacy access, workforce displacement, and increased medication costs.”
    • FEHBlog note — Good luck, CVS and ESI.
  • The Groom Law Group, which represents ERIC in its federal court lawsuit challenging the problematic to say the least 2024 mental health parity amendments, brings us up to date on the litigation, which so far has been successful.

From the public health and medical research front,

  • The Wall Street Journal lets us know,
    • “Adults diagnosed with autism spectrum disorder experience a range of benefits, including improved self-understanding, reduced self-blame and enhanced communication with others.
    • “The diagnosis can lead to positive changes in relationships, as individuals can now better explain their needs and behaviors to loved ones.
    • “Adults with autism may make adjustments to their routines and social interactions to accommodate their sensory sensitivities and communication challenges.”
  • Cardiovascular Business points out,
    • “Smoking marijuana and eating THC-based gummies have a negative impact on a person’s vascular health, according to new research published in JAMA Cardiology. In fact, the impact appears to be comparable to the damage seen in some tobacco users.
    • “There is a popular belief that marijuana smoke is harmless,” wrote first author Leila Mohammadi, MD, PhD, a vascular specialist with the University of California San Francisco, and colleagues. “However, marijuana smoke contains many of the thousands of chemicals contained in tobacco smoke, along with fine particles that contribute to cardiovascular morbidity and mortality. As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use.” * * *
    • “Click here to review the full analysis.”
  • Per MedPage Today,
    • “Use of the investigational non-opioid analgesic resiniferatoxin appeared to improve pain control in patients with advanced cancer who had intractable pain, though all patients experienced adverse events (AEs), according to an interim analysis of a first-in-human phase I trial.
    • “Among 19 patients with refractory cancer pain localized to the abdomen and/or lower extremities, a total of 213 treatment-emergent AEs were reported with a single intrathecal injection of resiniferatoxin, including 37 serious AEs in 14 patients, and at least one AE in all patients, reported Andrew J. Mannes, MD, of the NIH, and colleagues.” * * *
    • “In an accompanying editorial, Krishna B. Shah, MD, and Bilal Dar, MD, both of the Baylor College of Medicine in Houston, noted that the improvements in efficacy “exceeded thresholds typically considered clinically meaningful,” and that the drug has the potential to provide “durable, opioid-sparing analgesia while preserving functional and cognitive abilities.”
    • “These interim results “represent an important step toward expanding the therapeutic interventional opioid-sparing options for patients with refractory cancer pain,” they wrote.”
  • Medscape notes,
    • “Extreme fatigue, bone loss, and abdominal pain are real-world adverse events noted with the use of glucagon-like peptide 1 receptor agonists (GLP-1s) that may not have been apparent from the clinical trials.
    • “In a wide-ranging “meet the professor” lecture at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025, obesity expert W. Timothy Garvey, MD, the Charles E. Butterworth, Jr. professor and university professor at the University of Alabama (UAB) and director of the UAB Diabetes Research Center at Birmingham, Alabama, said these phenomena all point to the importance of close clinical management of people taking GLP-1s and to the dangers of online prescribing of these medications.
    • “You can’t engage in complications-centric obesity care unless you evaluate the patient for complications, which doesn’t happen with online availability of prescriptions,” said Garvey.”
  • Per BioPharma Dive,
    • “Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress.
    • “Lab tests showed the patient had grade 4 liver transaminase elevations that “appear to be resolving” without hospitalization or medical treatment and have since fallen to less dangerous levels, Intellia said in a filing with the Securities and Exchange Commission late Wednesday. “We continue to monitor these events as the Magnitude study progresses,” the company said.
    • “The Magnitude trial is testing Intellia’s experimental therapy in a type of deadly heart condition known as transthyretin amyloidosis with cardiomyopathy, or ATTR-CM. Intellia has already recruited 365 patients and plans to enroll a total of 765 by early 2027. Though the study is blinded, it’s likely that the patient with the potentially serious liver signals received treatment with Intellia’s therapy, analysts said.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Healthcare C-suite leaders are trying to keep pace with rapid changes in U.S. economic and regulatory policies in the first four months of the second Trump administration.
    • “Among 700 business executives across six industries, nearly half (48%) of business executives rank economic policy among the top three factors driving strategic change over the next one to two years, according to a new PwC May pulse survey. 
    • “For healthcare executives, persistent policy and market volatility is a bigger concern, with six out of 10 (61%) rethinking short-term business strategies due to economic policies.
    • “Leaders at healthcare organizations also cited a number of other factors affecting short-term strategic changes — AI and data regulations (56%), U.S. trade policy (44%) and U.S. federal government spending and budget policy (37%). Healthcare C-suite leaders seem less concerned about corporate tax policy, cited by 34% as a factor driving short-term strategic changes, as well as the U.S. antitrust and competition environment (24%), climate policy (22%) and U.S. immigration policy (22%).
    • “About half (48%) of the business executives surveyed expect the current uncertainty to last less than a year, but many anticipate it could extend through the next presidential election.” 
  • Modern Healthcare reports,
    • “Private practice is slowly fading as a way to do business, going the way of landline phones, bank deposit slips and fax machines.
    • “An analysis by the American Medical Association found the percentage of physicians in a practice wholly owned by physicians last year to be at the lowest level since the survey began in 2012. The AMA examined data from its biennial Physician Practice Benchmark Survey, most recently conducted in 2024.
    • “The percentage of physicians working in private practice has dropped below 45%.
    • “Of the remaining physicians surveyed, the highest percentage are employed by hospitals.
    • “Along with that shift, only 35% of physicians described their employment status as owners in 2024.”
  • The Wall Street Journal explains how Novo Nordisk lost its mojo in the GLP-1 drugs market.
    • “Novo Nordisk, once Europe’s most valuable company, is losing its grip on the anti-obesity market due to production issues and slow marketing.
    • “Eli Lilly’s weight-loss drug Zepbound has surpassed Novo Nordisk’s Wegovy in weekly U.S. prescriptions, and Lilly has a more promising pipeline.
    • “Novo Nordisk’s CEO was ousted, shares have tumbled, and the company faces challenges in R&D and direct-to-consumer marketing.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • ICER publishes Evidence Report on Treatment for Secondary Progressive Multiple Sclerosis
    • There are significant uncertainties regarding long term efficacy of tolebrutinib;
    • ICER estimates that treatment would achieve common thresholds of cost-effectiveness if priced between $3,250 and $5,900 per year.
  • Health Affairs concludes in a recent article,
    • “Because many value-based care programs in the US are fragmented, heterogeneous and complex, none are driving large-scale, systemic change. Clinical care redesign driven by value-based healthcare programs has been halting and has achieved far less than promised.
    • “A rising mood of despair over the ability to achieve a sustainable, high-value healthcare system is causing some to support interventions such as price controls and heavier regulation to drive down spending. However, a key missing ingredient in value-based reforms has been sufficiently nuanced information about the clinical context in which patients are treated. A primary challenge in finally achieving high value healthcare in the US is discovering how to harness the comprehensive and nuanced data generated in the provision of care, which is available in each patient’s EHR, to support systemic care redesign to achieve better outcomes at lower cost. Adding that key ingredient could be transformative.
    • “The system currently used to extract data from EHRs in the US, ICD-10-CM, does not adequately capture clinical detail and nuance. Gaps, limitations, and errors in describing healthcare today lead directly to our inability to accurately measure both the outcomes resulting from the care provided and the cost of that care. The WHO created and released ICD-11 to address these issues, and with an appropriate comprehensive extension such as ICD-11-CCL the ability to measure and attain value in healthcare would be achievable. However, even if the US loses access to ICD-11, there is another viable option. SNOMED CT is a comprehensive clinical terminology, optimized for the capture of clinical nuance, that uses architecture designed for computerized data analytics. It is already used to capture and store clinical content in EHRs and could be leveraged through the creation of a comprehensive code set to also extract and transmit data with all clinical nuance preserved. Such a system would overcome most, if not all, of the current limitations in ICD-10-CM and could empower existing value-based programs to improve the cost-effectiveness of healthcare.”
  • Per Fierce Healthcare,
    • “Retail giant Walmart is rolling out a new platform for insurers and benefit managers that’s designed to make it easier to encourage healthy eating.
    • “The tool, called Everyday Health Signals, is powered by artificial intelligence, analyzing a consumers’ retail history on Walmart.com to surface personalized feedback such as shopping lists and nutrition analyses. Given that the retailer sees 145 million customers each week in stores and online, it has a bevy of data to pull from, according to an announcement.
    • “Eligible customers can opt in to allowing Everyday Health Signals to dig into their shopping history, Walmart said.
    • “The program is initially launching in partnership with NationsBenefits, connecting its members to data they can use to meet key health goals. Walmart intends to expand to other insurers and benefits organizations in the future.”
  • and
    • “Humana is the latest major insurer to partner with digital sleep clinic Dreem Health to improve members’ sleep care.
    • “California-based Dreem Health was acquired by sleep diagnostics company Sunrise in December. The company already has partnerships with the country’s largest payers including Aetna, Blue Cross Blue Shield, Cigna, HealthNet, UnitedHealthcare and Medicare.
    • “Sunrise was built on the back of research conducted by Jean-Benoit Martinot, M.D., the father of Sunrise CEO and founder Laurent Martinot. The company developed a small device that patients are able to use to diagnose sleep disorders from anywhere—without the inconvenience of spending the night hooked up to wires in a lab—while still providing a near-similar level of information.
    • “Our dream today is to become the largest sleep clinic in the country,” said Laurent Martinot in an interview with Fierce Healthcare. “We already have the largest virtual care sleep clinic. We would like to become the No. 1 one place you go if you feel you are not sleeping well and you need some care.”
    • “The Sunrise device is a diagnostic tool that is able to measure jaw movements, muscle contractions and snoring noises (through a built-in mic) from the comfort of a patient’s own bed. It’s disposable and is able to record data for up to three nights. A report is generated after just one night of sleep, allowing a care team to engage and start next steps immediately.”
  • Modern Healthcare reports,
    • “Highmark Health is off to a challenging start to the year as its insurance business dinged the company’s bottom line during the first quarter.
    • “On Thursday, the privately held for-profit Blue Cross and Blue Shield licensee reported net income of $13 million, a steep decline from $194 million the prior year, as revenue rose 11% to $8 billion
    • “As we’ve seen with the nationals on the health plan side, elevated trends are here to stay,” said Carl Daley, chief financial officer and treasurer of Highmark Health.”
  • Per BioPharma Dive,
    • “Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights.
    • “ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug prospect, a TIGIT-targeting treatment developed with GSK.
    • “The immuno-oncology developer is the latest biotechnology company considering merger prospects or liquidatation of its assets this year. Others such as Cargo Therapeutics and Third Harmonic Bio have made their own plans to dissolve.”

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, SCOTUS, Telehealth, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • Bloomberg Law tells us,
    • US Health Secretary Robert F. Kennedy Jr.’s decision to pull the Covid-19 vaccine from the CDC’s recommended immunization list for healthy children and pregnant women means health plans must navigate whether to keep providing coverage for the shot. * * *
    • “Kennedy’s announcement in a video posted on X appeared to skip recommendations from the Advisory Committee on Immunization Practices, a panel of outside medical experts who guide the CDC on vaccine policy and vote for any new or updated recommendations to the schedule.
    • “The ACIP holds weight because the Affordable Care Act and the Inflation Reduction Act tie coverage in the commercial and Medicaid markets to the committee’s recommendations, attorneys say. That committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who can’t to afford them. 
    • “The panel is currently scheduled to meet starting June 26 to consider Covid-19 vaccines.
    • “The HHS did not respond to request for comment on further details of the announcement.”
  • Fierce Pharma informs us,
    • “While the Trump administration’s threat of pharmaceutical import tariffs and most favored nation (MFN) drug pricing has weighed heavily on the pharmaceutical industry in recent months, many branded drugmakers are well-positioned to handle the pressures.
    • “That was the perspective offered in a new report by S&P Global, which suggests that many global pharma companies can endure pricing pressures, trade duties and more, and that some of the most concerning policies floated by President Donald Trump are unlikely to materialize as planned.
    • “Still, Trump’s ambition to impose a most favored nation (MFN) drug pricing policy—which would attempt to close the gap between the costs of U.S. drugs and those in other countries—would be “highly negative” to branded drugmakers’ credit quality if enacted, the S&P team cautioned.”

In Food and Drug Administration news,

  • BioPharma Dive lets us know,
    • “Abbott said Tuesday it received Food and Drug Administration approval for the Tendyne transcatheter mitral valve replacement system to treat calcium buildup in the ring that supports the heart valve.
    • “The device is available for patients with severe mitral annular calcification who are not candidates for open heart surgery or transcatheter mitral valve repair.
    • “Abbott’s MitraClip system for mitral valve repair competes with Edwards Lifesciences’ Pascal repair device. The rivals are now set to compete in mitral valve replacement: Edwards won Europe’s CE mark last month for the Sapien M3 transfemoral system and expects U.S. approval in 2026.”
  • and
    • “Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices. 
    • “Boston Scientific said in a regulatory filing that the decision followed recent discussions with regulators, adding that the products faced increased requirements to maintain approvals in global markets and to obtain approvals in new regions.”

From the judicial front,

  • Yesterday, the U.S. Solicitor General filed with the Supreme Court a requested amicus brief recommending that the Court not review a U.S. Court of Appeals for the 10th Circuit decision that overrode parts of Oklahoma’s PBM reform law based on ERISA and Medicare preemption. The Supreme Court is likely to make a ruling on this issue next month. The FEHBlog is happy about this development.
  • Modern Healthcare reports,
    • “An Elevance Health subsidiary is suing the billing dispute consulting company HaloMD and two hospital-based Georgia providers, alleging they conspired to exploit the No Surprises Act.
    • “Blue Cross Blue Shield Healthcare Plan of Georgia, which operates under Elevance Health’s Anthem brand, filed the suit in the U.S. District Court for the Northern District of Georgia on Tuesday. The company alleges HaloMD and its out-of-network clients inappropriately won higher reimbursements through the No Surprises Act’s independent dispute resolution, or IDR, system.
    • “Defendants procured improper payments from [Blue Cross Blue Shield of Georgia] on thousands of disputes. Indeed, nearly 70% of disputes on which defendants received an IDR payment determination were clearly ineligible for the process. Since 2024, defendants’ scheme has caused millions of dollars in damages, and it continues to harm [Blue Cross Blue Shield of Georgia], employer plan sponsors and other managed care companies,” the insurer wrote in its complaint.
    • “Elevance Health estimates it spent $5.9 million on excess reimbursements and IDR fees from Jan. 3, 2024, to April 29, 2025.”
    • Unquestionably the IDR system needs to become more transparent to the parties.

From the public health and medical research front,

  • ABC News relates,
    • “About a month ago, the rate of new measles cases was accelerating at a seemingly unprecedented rate with more than 100 infections being confirmed every week.
    • “However, over the last couple of weeks, the rate of newly confirmed cases appears to be slowing.
    • “The Centers for Disease Control and Prevention (CDC) confirmed an average of 22 weekly cases over the last two weeks.
    • “Even in western Texas, which had been driving most new cases in the U.S., about 11 cases have been confirmed since May 23.
    • “Public health experts told ABC News they believe measles cases are slowing down due to a mix of vaccination, a build of natural immunity and people staying home when sick.”
  • The Washington Post points out,
    • “Scores of researchers have produced new tools that can deliver genes and selectively activate them in hundreds of different cell types in the brain and spinal cord, a breakthrough that scientists hope advances them toward developing targeted therapies to treat neurodegenerative diseases such as ALS, Parkinson’s disease and Alzheimer’s.
    • “The discoveries, made through the National Institutes of Health’s BRAIN initiative, show with unprecedented clarity and precision how neural cells work together, but also how diseases disrupt their tight choreography. The insight offers the promise that doctors may one day treat diseases by manipulating dysfunctional cells.
    • “Looking ahead, with sustained investment, the advances we can achieve in understanding consciousness — and in repairing neurological and neuropsychiatric disorders — will be nothing short of life-changing,” Gord Fishell, a professor of neurobiology at Harvard Medical School and one of the scientists involved in the discoveries, said in an interview for the BRAIN webpage. “This will revolutionize both our grasp of how the brain works and our ability to treat currently intractable conditions.”
  • Per MedPage Today,
    • “Self-reported maternal mental health declined in recent years, as did maternal physical health, though less drastically, a cross-sectional study suggested.
    • “After adjustments for secular changes in sociodemographic groups, “excellent” physical health decreased by 4.2 percentage points, “excellent” mental health decreased by 12.4 percentage points, and “fair/poor” mental health increased by 3.5 percentage points from 2016 to 2023, reported Jamie Daw, PhD, of the Columbia University Mailman School of Public Health in New York City, and colleagues in JAMA Internal Medicine.
    • “Daw told MedPage Today that this decline in mental health was even greater than what she and her team were expecting to find. Recent research has focused on the impacts of the COVID-19 pandemic on mental health, but this study indicated that the downward population-level trends were happening before 2020.
    • “This is not just a pandemic story — it’s much broader than that,” Daw said. “This study helps us expand our thinking about when we should be caring about the health of mothers, and in pointing out that it is well beyond the perinatal period.”
  • and
    • “For patients with major depression, there was a clinically meaningful but not statistically significant improvement in the primary endpoint with 20-mg azetukalner.
    • “There were significant improvements in secondary endpoints.
    • “A phase III trial of azetukalner in major depressive disorder is now underway.”
  • The McKinsey Health Institute discusses how “the advent of weight management drugs such as GLP-1s have brought the treatment of obesity to the forefront of public attention, provoking a larger opportunity to work toward metabolic health for all.”

From the U.S. healthcare business front,

  • HHS’s Agency for Healthcare Research and Quality notes,
    • “In 2022, the top 1 percent of people ranked by their healthcare expenditures accounted for 21.7 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “People with the top 1 percent of expenses had an average of $147,071 in healthcare expenditures in 2022, which was lower than in 2021.
    • “People ages 65 and older and non-Hispanic Whites were disproportionately represented in the above median expenditure tiers.
    • “Ambulatory events, inpatient stays, and prescribed medicines each accounted for about 30 percent of healthcare expenses for people with the top 5 percent of expenses.
    • “Over three-quarters of expenses for people with the top 5 percent of expenses were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 75.1 percent had two or more of the AHRQ-designated priority conditions.”
  • MedCity News tells us,
    • “Most large employers plan to uphold their well-being benefits in 2025 even though they’re facing increasing healthcare costs and global economic headwinds, according to a recent survey from the Business Group on Health.
    • “The Business Group on Health is a nonprofit advocacy organization for large employers. The survey included responses from 131 employers that employ 11.2 million people across the world. Conducted in January and February, it follows another Business Group on Health survey that projected healthcare costs to rise nearly 8% in 2025, the highest increase in over a decade.
    • “The new survey found that 73% of employers plan to maintain their well-being programs in 2025, while 20% will be expanding their programs. The remainder will either decrease their well-being programs or are unsure.” 
  • Fierce Healthcare informs us,
    • “Customer satisfaction with health plans is on the decline, and the gap between the highest and lowest performers is getting wider, according to a new report.
    • “J.D. Power released its annual study looking at consumers’ attitudes toward commercial health plans, which found that the average satisfaction score for this market is 563 on a 1,000-point scale. But there is notable variation in scores based on geography and plan, with a high of 594 and a low of 523.
    • “The J.D. Power report said this means plan members in different parts of the country are having different experiences and finding varied value in their coverage.
    • “Member experience is a critical differentiator for employers and plan sponsors, with 20% of employers saying they switched plans due to low satisfaction among employees. Plans that separate themselves from the pack have invested in engagement, education and service, according to the study.”
  • STAT News lets us know,
    • “A new digital health care marketplace, launched last week, has a good amount of Amazon in its DNA. General Medicine, with $32 million in funding, came out of stealth with three former Amazon employees as co-founders and investors, a business model that could compete with Amazon’s One Medical — and behind the scenes, a current senior Amazon executive. 
    • “The former employees, including the founders of PillPack — the pharmacy company that Amazon bought in 2018 for about $750 million and grew into Amazon Pharmacy — bill General Medicine as a “one-stop shop for expert care” that connects patients to its own telehealth medical practices and to outside care. Sunita Mishra, Amazon Health Services’ chief medical officer, is the physician owner of one of those practices and advised the company early on, General Medicine and Mishra confirmed.”
  • Modern Healthcare reports,
    • “ChristianaCare plans to assume operations of five Crozer Health outpatient facilities in Pennsylvania after submitting the highest bid of $50.3 million. 
    • “The auction was held as Prospect Medical Holdings, Crozer’s parent company, seeks to sell the system’s assets after filing for Chapter 11 bankruptcy protection in January. The sale to Wilmington, Delaware-based ChristianaCare is subject to court approval, according to a Wednesday news release. 
    • “The sale includes two facilities in Glenn Mills, Pennsylvania as well as single facilities in Havertown, Broomall and Media, Pennsylvania. ChristianaCare said it is evaluating the programs and services offered at each location to determine what will be continued, expanded or revamped.”
  • Per Beckers Hospital Review,
    • “Secaucus, N.J.-based Hudson Regional Health, a four-hospital system, has been created as part of the final step in CarePoint Health’s bankruptcy exit.
    • “U.S. Bankruptcy Judge Kate Stickles approved the plan April 17, which went into effect May 22. The system comprises Secaucus-based Hudson Regional Hospital, Jersey City-based Christ Hospital, Hoboken (N.J.) University Medical Center and Bayonne (N.J.) Medical Center, and more than 70 affiliated locations, according to a May 27 Hudson Regional Health news release shared with Becker’s.”
  • “and provides a list of ten new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Tuesday Report

David Ermer–CDC, CMS, Congress, COVID-19, Electronic health records, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Joshua Hoehne on Unsplash

From Washington, DC,

  • Govexec tells us,
    • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
    • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
    • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
  • RIP, Congressman.
  • The Wall Street Journal reports,
    • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
    • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
    • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
    • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
    • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 
  • Per the New York Times,
    • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
    • “The early morning vote was 215 to 214, mostly along party lines.”
  • Fierce Healthcare adds,
    • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
    • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
    • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
    • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
    • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
  • and
    • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
    • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
    • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
  • Per an CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

  • BioPharma Dive points out,
    • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
    • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
    • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
  • and
    • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
    • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
    • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”
  • MedTech Dive adds,
    • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
    • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
    • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”
  • The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
    • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
    • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
    • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
    • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
    • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”
  • Per STAT News,
    • “In what researchers hope could be a case of 1 + 1 = 3, new research suggests that combining a model to predict 10-year cardiovascular risk with an imaging test of coronary arteries could be better than either method alone at identifying people in danger of their first heart attack.
    • “The model is PREVENT, which computes a risk score based on measures familiar from the primary care office: blood pressure, cholesterol levels, kidney function, age, and BMI, as well as questions about type 2 diabetes, smoking, and social determinants of health. The imaging test is a CT scan that detects calcium buildup in arteries leading to the heart. High amounts of calcium, alone and inside fatty plaques, can lead to blockages and heart attacks.” * * *
    • “It’s not always clear who should be screened for coronary calcium; thus, we decided to see if the PREVENT score could be used in this novel manner,” Morgan Grams of New York University’s Grossman School of Medicine told STAT. She is an author of the study published Wednesday in the Journal of the American Heart Association. “Once we determined that it could, we assessed whether the coronary calcium score could add information to PREVENT in the prediction of incident cardiovascular disease. It did.”
       
  • Per a National Institute of Health news release,
    • Research teams funded by the National Institutes of Health (NIH) have created a versatile set of gene delivery systems that can reach different neural cell types in the human brain and spinal cord with exceptional accuracy. These delivery systems are a significant step toward future precise gene therapy to the brain that could safely control errant brain activity with high precision. In contrast, current therapies for brain disorders mostly treat only symptoms.
    • The new delivery systems carry genetic material into the brain and spinal cord for targeted use by specific cell types. This platform has the potential to transform how scientists can study neural circuits. It provides researchers with gene delivery systems for various species used in research, without the need for genetically modified, or transgenic, animals. Examples include illuminating fine structures of brain cells with fluorescent proteins and activating or silencing circuits that control behavior and cognition.
    • “Imagine this new platform as a delivery truck dropping off specialized genetic packages in specific cell neighborhoods in the brain and spinal cord,” said John Ngai, Director of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “With these delivery systems, we can now access and manipulate specific cells in the brain and spinal cord – access that was not possible before at this scale.”
  • Healio notes,
    • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
    • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
    • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
    • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”
  • Fierce Healthcare reports,
    • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
    • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
    • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
  • Fierce Pharma relates,
    • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
    • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
    • “Evernorth added that the costs will contribute toward a patient’s deductible as well.
  • CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  • Per STAT News,
    • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
    • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
    • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”
  • Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.” 

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”