Thursday report

Medical / Rx research

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–

Happy Lincoln’s Birthday

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Department of Homeland Security is on the verge of a shutdown after Senate Democrats voted to block a bill to fund the agency, saying negotiations with Republicans to put new restrictions on immigration enforcement hadn’t made enough progress.
    • “A bill to fund DHS through September failed to advance with 52 in favor and 47 opposed, short of the 60 votes required. Republicans control the Senate 53-47 but need Democratic support to pass most bills due to the longstanding filibuster rule.
    • “Democratic Sen. John Fetterman of Pennsylvania voted with Republicans to advance the bill, while Senate Majority Leader John Thune (R., S.D.) switched his vote from yes to no to preserve his ability to bring the bill up again. Sen. Mitch McConnell (R., Ky.) was absent.
    • “DHS oversees Immigration and Customs Enforcement and Customs and Border Protection as well as the Federal Emergency Management Agency, the Transportation Security Administration and the U.S. Coast Guard. While the failed vote sets the stage for funding to lapse at DHS for at least a week, there isn’t expected to be any significant impact on border enforcement from the shutdown.”
  • The Washington Post adds,
    • “The Senate is not expected to hold any more votes before a shutdown starts at 12:01 a.m. Eastern time on Saturday, and many senators were set to leave town Thursday to travel to the Munich Security Conference. Schumer and Thune have said they are prepared to bring senators back early if a deal comes together.” * * *
    • “This shutdown would affect only DHS — but it would not shutter U.S. Immigration and Customs Enforcement or Customs and Border Protection, because Republicans sent those agencies tens of billions of dollars in additional funding last year that would allow them to continue to operate.
    • “Instead, the brunt of a shutdown would fall on the Transportation Security Administration, the Federal Emergency Management Agency, the Coast Guard and other agencies within DHS. It would affect about 13 percent of the federal civilian workforce, most of whom would be forced to work without pay, according to data from DHS and the Office of Personnel Management.”
  • The Wall Street Journal tells us
    • “The White House and Health Secretary Robert F. Kennedy Jr. have shaken up the top ranks at his department, a move meant to install more disciplined messengers and smoother operations ahead of the midterm elections.
    • “Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said.
    • “We’re structuring in such a way that we can move faster and we can make sure the quality is uniform,” Klomp said in an interview.” * * *
    • “The three other senior advisers tapped to help Klomp include John Brooks, who currently heads policy at the Centers for Medicare and Medicaid Services; Grace Graham, who leads the Food and Drug Administration’s policy office; and Kyle Diamantas, who heads FDA’s food division. Brooks will oversee CMS matters, while Graham and Diamantas will have roles managing the FDA.”
  • Beckers Payer Issues informs us,
    • “Fourteen health insurers have voluntarily committed to CMS’ “Advancing Chronic Care with Effective, Scalable Solutions” model, according to a Feb. 12 CMS news release shared with Becker’s.
    • “The insurers that are on board will work toward achieving alignment with the model by 2028. The plans represent 165 million Americans.
    • “With a decade-long evaluation period beginning in July, ACCESS will explore whether linking payments to clinical outcomes can facilitate technology in chronic disease management, focusing on Medicare beneficiaries. Targeted conditions include high blood pressure, diabetes, chronic musculoskeletal pain and depression. The agency began accepting applications, which are due in April, on Jan. 12.
    • “The FDA’s “Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot” will operate in conjunction with ACCESS, allowing expanded availability of relevant devices.”
  • The Internal Revenue Service issued a draft of Publication 969 Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2025 Returns.
  • The American Hospital Association News lets us know,
    • “A bipartisan letter supported by the AHA was sent by members of Congress Feb. 11 to the Department of Homeland Security, urging the agency to grant health care workers an exemption from the $100,000 filing fee for H-1B visas. The letter, led by Reps. Yvette D. Clarke, D-N.Y., and Michael Lawler, R-N.Y., was signed by 100 lawmakers. “Imposing a $100,000 fee for new H-1B visa petitions will exacerbate hospitals’ existing staffing challenges and could push chronically underfunded hospitals to their financial brink,” the legislators wrote. “If these hospitals cannot petition for new H-1B visas to address their staffing needs without also having to pay this fee, it will further damage their financial viability. Critically needed open positions will simply go unfilled, leaving rural and high-poverty urban areas without adequate access to care.”
  • and
    • “The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies targeting viruses in the Togaviridae and Flaviviridae families, such as dengue, Zika, West Nile and Chikungunya. The initiative, called the Small Molecule Approaches for Rapid and Robust Treatment Prize, will be coordinated by ASPR’s Biomedical Advanced Research and Development Authority. BARDA plans to include input from experts in drug development, virology, artificial intelligence, medicinal chemistry and public health for the program. A series of virtual information sessions will be held in the coming weeks on the initiative, which has a May 11 application deadline.” 
  • Federal News Radio interviews Tammy Flanagan about federal employee retirement benefits.
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC), together with the Office of Personnel Management (OPM), today provided federal agencies with a joint technical assistance document addressing telework as a reasonable accommodation for federal employees with disabilities.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.
    • “Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.
    • “The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makaryand Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.”
  • and
    • “The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.”

From the judicial front,

  • Fierce Pharma reports,
    • “In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.
    • “While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering.”
    • “When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. 
    • “AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “Interest in lipoprotein(a), or Lp(a), is on the rise thanks to mounting evidence that the genetically inherited lipid particle may be a key missing link in unexplained heart attacks and strokes. While current treatments are limited, experts say that will likely change in the near future when new drugs begin to enter the market.
    • :Nathaniel Lebowitz, MD, who leads preventive cardiology at Hackensack University Medical Center and serves as an assistant professor of internal medicine at Hackensack Meridian School of Medicine, has spent two decades studying this biomarker. He is now part of the American Heart Association (AHA) Lp(a) Discovery Project, a national initiative aimed at expanding physician and patient awareness as new therapies move closer to market. Lebowitz spoke with Cardiovascular Business at length about this important topic.
    • “Lp(a) is a major, major killer. And most of the population, and even most doctors, don’t know the exact degree of how dangerous it really is,” he explained.
    • “Lebowitz noted that Lp(a) is often responsible when patients suffer cardiovascular events despite not showing any of the normal warning signs.
    • “When somebody who you wouldn’t expect to have a stroke or a heart attack has one and does not have traditional risk factors to speak of, check Lp(a), because it will be positive,” he said.
    • “Lp(a) is genetic and present in about 20% of the general population. Guidelines from the AHA, American College of Cardiology and National Lipid Association now emphasize screening in individuals with a family history of premature heart disease, as well as cascade screening of first-degree relatives when Lp(a) is identified. Levels typically do not fluctuate significantly, so testing once is believed to be generally sufficient.
    • “I consider it a risk elevator. It’s a risk multiplier,” Lebowitz said. “So if somebody is considered low risk for cardiovascular disease, but they have Lp(a) now, I would consider them intermediate risk. If they’re intermediate risk, but they have Lp(a), I would now consider them high risk and treatment should ensue accordingly.”
    • “Currently, there are no approved therapies specifically targeting Lp(a), but that may soon change. Several investigational agents are in late-stage clinical trials, including small interfering RNA (siRNA) therapies designed to silence the gene responsible for producing Lp(a).”
  • The New York Times provides a look at what alchohol does to your body.
    • “Dry January has come and gone, but Americans’ relationship with drinking is undergoing a more lasting change. According to one recent poll, just 54 percent of U.S. adults said they consume alcohol, the smallest percentage in nearly 90 years of data collection. That may be because more people are taking alcohol’s negative health consequences seriously.
    • “Drinking alcohol can have profound effects on the brain and body. In the moment, some of those effects can be pleasurable. But in the long term, especially when it’s consumed in large quantities, alcohol can cause serious health harms.”
  • and tells us,
    • “Fertility experts know that the more eggs retrieved from a woman, the better the chances that one of them will lead to a viable embryo that will result in the birth of a baby.
    • “Now, a new study suggests something startling, even to many in the field: the conventional method of searching for eggs often fails to find all of them, and a new technology that automates the process may significantly increase the number recovered.
    • Using the conventional method, embryologists use high-powered microscopes to search the follicular fluid extracted from women in fertility clinics. The fluid is then discarded. The study, published in Nature Medicine on Thursday, reported that a device that uses microfluidic technology to sift through follicular fluid found additional eggs for more than half of the patients.
    • “It’s very, very surprising,” said Dr. Mitchell Rosen, who directs the reproductive laboratories at the University of California, San Francisco and was not involved in the study. “They were finding eggs that we wouldn’t otherwise have had the potential to use.”
  • MedPage Today informs us,
    • “Receiving an mRNA SARS-CoV-2 vaccine during or shortly before pregnancy had no impact on kids’ neurodevelopmental outcomes, a multicenter prospective observational study found.
    • “Kids between ages 18 and 30 months scored similarly on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) (adjusted median difference -3.4, 95% CI -9.7 to 3.0) as well as in each of the five specific ASQ-3 domains, reported George Saade, MD, of Eastern Virginia Medical School in Norfolk, Virginia, during a presentation at the Society for Maternal-Fetal Medicine (SMFM) annual meeting.
    • “Scores on other neurodevelopment assessments that evaluated emotional and behavioral problems, risk for autism spectrum disorder, and temperament were also similar between groups.
    • “We conclude that the primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy, and there was no association with secondary neurodevelopmental outcomes,” Saade said during his presentation.
    • “Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination and pregnancy,” he added.
    • “Indeed, much research has found no link between COVID vaccination in pregnancy and adverse outcomes for children, including at least two studies showing no increase in birth defects.”
  • BioPharma Dive observes,
    • “An experimental medicine from BridgeBio Pharma, the San Francisco-area biotechnology company, has succeeded in a late-stage clinical trialas a treatment for the most common type of dwarfism, results which could tee up an approval and greater competition for two other closely watched therapies.
    • “The trial enrolled around 110 children with achondroplasia, who, over a main treatment period of a year, were given either a placebo or BridgeBio’s drug, called infigratinib. On Thursday, BridgeBio announced that those in the drug arm were growing taller faster. Depending on the measure, this “annualized height velocity” was, on average, between 1.74 and 2.1 centimeters greater per year than what researchers observed in the control group.
    • “Not only did infigratinib meet the trial’s central goal, it also scored so well on a couple other height and growth tests that BridgeBio said it set records for a randomized study of achondroplasia patients. The drug was well tolerated, too, as no serious adverse events were tied to it. No one dropped out of the trial because of side effects either. BridgeBio did disclose three cases of patients having abnormally high levels of phosphate in their blood, but all were mild, transient, asymptomatic, and didn’t require the dose given to be changed or stopped.”
  • Beckers Hospital Review notes,
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s drug shortage database.
    • “Eighty drugs were in shortage as of Feb. 12, down from 194 in mid-June.
    • “The decline reflects updates to the FDA’s database, which is modified daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also points out “12 recent drug shortages, according to the FDA database.”

From the U.S. healthcare business front,

  • Per an Institute of Clinical and Economic Review news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Medication for Smoking Cessation
    • “Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared to varenicline; Manufacturer setting a price for cytisinicline to align with value would help ensure public health goals for smoking cessation are met.”
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • Beckers Payer Issues reports,
    • “Most of the country’s largest insurers reported year-over-year increases in medical cost ratios in 2025.
    • “Centene reported the highest medical loss ratio at 91.9%, driven by higher marketplace medical costs, Medicaid cost pressures in behavioral health and home health, and program changes in the Medicare prescription drug plan business.”
    • The article provides the largest insurers MLRs for 2023, 2025 and 2025.
  • Healthcare Dive relates,
    • “Hospital operator Tenet Healthcare expects the expiration of more generous Affordable Care Act subsidies to lower its earnings growth this year by about $250 million.
    • “Still, Tenet’s expected loss is smaller than those of some of its peers, including HCA Healthcare, which last month said it expects to lose up to $900 million from the lapse of the enhanced tax credits in 2026.
    • “Excluding the ACA headwind and the impact of some Medicaid state supplemental payments, Tenet anticipates it will grow adjusted earnings before taxes and other non-operating expenses by about 10% this year compared to 2025, executives said on a Wednesday call with investors.”
  • BioPharma Dive tells us,
    • “Sanofi on Thursday announced the ouster of CEO Paul Hudson after a six-year tenure that included a major transformation of the French drugmaker and the rise of Dupixent into one of the world’s best-selling medicines.
    • “Hudson will be replaced by current Merck KGaA CEO Belén Garijo, who is leaving her post at the German company at the end of April as part of a planned transition. Olivier Charmeil, executive vice president for general medicines, will serve as interim CEO after Hudson’s departure at the close of business on Feb. 17, Sanofi said.
    • “Belén Garijo will bring an increased rigor to the implementation of Sanofi’s strategy and accelerate the preparation of the group’s future,” Sanofi said. “Her priority will be to strengthen the productivity, governance and innovation capacity of research & development.”
  • Fierce Healthcare informs us,
    • “Maven Clinic, a virtual women’s and family health provider, is teaming up with health tech company Color Health to support family building after a cancer diagnosis. 
    • “The partnership’s goal is to expand access to oncofertility care, helping patients of childbearing age going through the cancer journey to understand and preserve their fertility options. Members will receive access to oncologists, dietitians, mental health providers, fertility preservation specialists and care advocates. The services will be available to cancer patients through employers and payers to start. 
    • “Both of us have seen the attention being paid by employers to what it really looks like for their team members going through a cancer diagnosis, because it’s happening at such a rapid clip now,” Caroline Savello, president at Color, told Fierce Healthcare. A quarter of Color patients are between the ages of 18 and 45.”
  • and
    • “Specialty care company Lantern revealed it will expand its cancer care navigation platform through a new partnership with AccessHope.
    • “Through the partnership, Lantern’s platform will now include expert review at each point in a patient’s care journey, preventing misdiagnoses and ensuring treatments meet clinical guidelines. Reviews will be conducted by experts at National Cancer Institute (NCI)-designated cancer centers, according to the announcement.
    • “Lantern said the reviews will be available for both adult and pediatric cancers as well as solid tumors and blood-based disease.
    • “Dickon Waterfield, president of Lantern, told Fierce Healthcare that the “beauty of this partnership” lies in the ability to allow people to seek care in their local communities while also providing them supports at the standard of an NCI-designated facility.”

Midweek report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Republicans and Democrats sparred Wednesday on the potential real-world harms of a partial shutdown for the Department of Homeland Security, as Congress marched toward a funding deadline for the agency amid a dispute over immigration enforcement policies.
    • “The House Homeland Security Appropriations Subcommittee held a hearing with officials from five national security and emergency management agencies to highlight what would happen if a continuing resolution expires Saturday without further action from Congress.”
  • and
    • “Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. 
    • “At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries.
    • “But Guthrie stressed that further changes could be forthcoming.
    • “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.”
    • “Rep. Morgan Griffith, R-Va., chair of the Health Subcommittee, said after the hearing that he hopes to mark up affordability legislation before Memorial Day, but acknowledged the appetite for bipartisan cooperation will be “tough” given the political climate.” 
  • Beckers Payer Issues adds,
    • “Sens. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., have introduced legislation that would ban health insurers and pharmacy benefit managers from owning medical providers, and would force companies in violation to divest within one year of the bill’s enactment.
    • :The “Break Up Big Medicine Act” would also prohibit a parent company of a prescription drug or medical device wholesaler from owning a medical provider or management services organization.”
  • The American Hospital Association tells us,
    • “The Senate Special Committee on Aging held a hearing Feb. 11 on issues impacting physician burnout. The AHA provided a statement for the hearing and urged Congress to pass legislation to address burnout, including the Improving Seniors’ Timely Access to Care Act (H.R. 3514/S. 1816), legislation that would streamline prior authorization requirements under Medicare Advantage plans by making them simpler and more uniform, and the Save Healthcare Workers Act (H.R. 3178/S. 1600), a bill that would make it a federal crime to assault a hospital employee. The AHA also urged Congress to pass the Resident Physician Shortage Reduction Act of 2025 (H.R. 3890/S. 2439), which would add 14,000 Medicare-funded residency positions over seven years.”
  • Per OPM news releases,
    • [On February 10, 2026], the US Office of Personnel Management (OPM) convened senior administration officials, federal agency leaders, and industry executives at the White House for a US Tech Force (Tech Force) roundtable focused on strengthening the federal government’s technology workforce and accelerating innovation across agencies.
  • and
    • “US Office of Personnel Management (OPM) Director Scott Kupor appeared on Fox Business to discuss the administration’s launch of the U.S. Tech Force, a new initiative aimed at strengthening the federal workforce with top technical talent and modernizing critical government systems.” You can watch the Director’s appearance here.
  • Govexec discusses the tax implications of making Roth IRA conversions in the Thrift Savings Plan.
    • “Beginning Jan. 28, the Thrift Savings Plan now allows participants to convert traditional (pre-tax) balances into Roth (after-tax) balances inside the TSP itself. This long-awaited change gives federal employees and retirees more flexibility over how and when they pay taxes on retirement savings.
    • “While the mechanics of the change are straightforward, the implications are not. A Roth in-plan conversion is a tax event and not just a retirement planning decision. Once it is made, it cannot be reversed. Knowing this beforehand helps you choose effective planning tools and avoid costly errors.”
  • Per an HHS news release,
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “ASTP/ONC released the draft USCDI v7 on January 29, 2026, proposing 29 new data elements and one significantly revised element to strengthen nationwide interoperability. Draft USCDI v7 expands standardized health data to support more efficient adverse event reporting, nutrition information exchange, and quality improvement, ultimately modernizing how health information is used across the entire health care system to Make America Healthy Again.”
    • “In the coming days, ASTP/ONC will launch the EHIgnite Challenge, a two-phase prize competition to improve the usability, readability, and actionability of single-patient electronic health information (EHI) exports. The EHIgnite Challenge will catalyze the development of tools and workflows, focused on the application of AI, that transform raw EHI into clear, usable information to better support care transitions, provider onboarding, and patient understanding and engagement. Awards will support both concept development and prototype solutions through 2027.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.
    • “But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.
    • “With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. 
    • “Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. 
    • “The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago.” 

From the public health and medical / Rx resarch front,

  • STAT News reports,
    • “Food fights pitting low-carbohydrate diets against low-fat diets are off the mark when they aim at heart health, a large new study suggests. To reduce heart disease risk, it’s the quality, not the quantity, of those carbs or fats that matter. Diets high in plant-based foods, whole grains, and unsaturated fats led to better heart health, the researchers found. Low-fat dairy also got a nod when part of a diet featuring whole grains, vegetables, and fruits.
    • “Not all carbs are created alike; nor are all fats. Whole grains, fruits, vegetables, nuts, legumes, and olive oil are associated with lower risk of coronary heart disease (CHD), whether they contain carbohydrates or fats. But diets high in refined carbohydrates and animal proteins and fats were associated with a higher risk of heart disease, according to the new study, published Wednesday in the Journal of the American College of Cardiology.” 
  • MedPage Today relates,
    • “The CDC excludes homicide, suicide, and overdose in defining “maternal mortality,” instead focusing on more medical causes.
    • “An analysis of 2018-2023 data showed that drug overdoses, homicides, and suicides accounted for more than a quarter of all deaths among pregnant and postpartum women.
    • “Violence and overdose accounted for 2,018 deaths, while cardiovascular causes, hypertension, infection, and hemorrhage together accounted for 2,141 deaths [over the period 2018-2023].” * * *
    • “Maeve Wallace, PhD, MPH, of the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson, told MedPage Today that the results were not surprising.
    • “Research dating back decades finds that rates of violent death exceed obstetrical causes of death for pregnant women,” Wallace said. “What is disheartening is that this continues to be the case.”
    • “This analysis “can help policymakers concerned with maternal health understand pregnancy as a dangerous condition,” and can encourage policy-level solutions to promote women and girls’ health and safety, she added.”
  • and
    • “A meta-meta-analysis of randomized trials showed exercise reduced depression and anxiety symptoms.
    • “Group aerobic exercise appeared to be most effective for depression, while exercise of shorter duration and lower intensity was most associated with reductions in anxiety symptoms.
    • “The researchers concluded that tailored exercise programs are an “accessible and cost-effective” treatment option for depression and anxiety.”
  • Healio informs us,
    • “Statin use had a statistically significant protective effect against acute asthma exacerbations in mild asthma among Black adults and adults with obesity, according to data published in Annals of Allergy, Asthma & Immunology. 
    • “The pleiotropic effects of statins may extend beyond cholesterol control due to their anti-inflammatory and immunomodulatory properties, prompting interest in their potential use for chronic airway diseases, William Crawford, MD, physician with the department of allergy, Kaiser Permanente Southern California, and colleagues wrote.
    • “But mixed results in prior research including beneficial and null effects in asthma outcomes indicate that determining the patient subgroups that may benefit most from treatment is vital in determining the role that statins may have in asthma management.” 
  • The American Journal of Managed Care observes,
    • “More than half of patients with long-term conditions (LTCs) surveyed said they preferred a remote consult vs an in-person visit with their referring physician, particularly for discussion of results and medication renewal, according to a new study
       published in JAMA Network Open.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. economy added 130,000 jobs in January, its strongest growth in over a year, and a sign that the labor market may be shaking off its recent stagnation.
    • “January’s robust gains surprised forecasters, blowing far past consensus expectations, while solidifying expectations the Federal Reserve will keep rates on hold for the foreseeable future. The unemployment rate dipped to 4.3% from 4.4% in December, the Labor Department said Wednesday. And workers’ wages rose.
    • “The gains were highly concentrated in healthcare and social-assistance fields, which includes jobs like home health aides and residential care workers. Such jobs tend to grow regardless of the economy’s health and have long been an engine of U.S. job growth.”
  • Fierce Healthcare relates,
    • “Humana CEO Jim Rechtin acknowledged the noise around the latest Medicare Advantage rate notice and said that while the flat proposal is a concern, the company will continue to push forward on its performance improvements.
    • “He said that part of the challenge for policymakers, regardless of political alignment, is managing the program as it “sits at the intersection of U.S. fiscal pressures and a program that is incredibly popular with seniors.”
    • “Every administration wrestles with how to balance these two forces,” Rechtin said.
    • “We are committed to always protecting our consumers the best we can, and we are very aware that we must do that within the constraints of the annual funding environment,” he continued. “If that funding environment cannot fully support our benefit structure, then we will adapt as we have in the past.” * * *
    • “Humana reported a $796 million loss in the fourth quarter of 2025, with its losses growing year over year as increased utilization continues to drag Medicare Advantage (MA) plans.
    • “By comparison, Humana reported a $693 billion loss in the fourth quarter of 2024. The company did post a profit for the full year of $1.2 billion, flat from the company’s $1.2 billion haul in 2024.”
  • and
    • “Hinge Health’s shares were up 13% in after-hours trading Tuesday after the digital health company reported a strong fourth quarter and a bright outlook for 2026.
    • “The digital musculoskeletal (MSK) care provider, which went public in late May, brought in fourth-quarter revenue of $171 million, up 46% from the same period a year ago and easily topping Wall Street analyst estimate of $155 million for fourth-quarter revenue. The company posted fourth-quarter adjusted earnings of 49 cents per share, significantly exceeding analyst estimates of 14 cents per share. Hinge Health’s non-GAAP income from operations increased 124% to $48 million during quarter.
    • “Free cash flow for the quarter was $61.5 million, representing a free cash flow margin of 36%.
    • “The company’s full-year 2025 revenue jumped 51% year over year to reach $588 million compared to revenue of $390 revenue in 2024, according to its fourth-quarter and full-year financial results.” 
  • KFF lets us know,
    • “National spending on health has increased rapidly over time—rising to $5.3 trillion and 18% of GDP in 2024—and is projected to continue to do so into the future. Growth in health spending contributes to higher costs for families, employers, Medicare, Medicaid, and other payers. In 2025, average annual premiums for employer-sponsored family coverage reached $26,993, with workers paying $6,850 for their coverage, according to KFF’s annual survey of employers.  Hospital care accounted for nearly one-third of national health expenditures in 2024, and more than doubled in nominal terms over the preceding two decades, making hospitals a major driver of health spending growth over time.” * * *
    • “National health expenditures increased by $692 billion between 2022 and 2024, from $4.6 trillion to $5.3 trillion. During this period, spending on hospital care alone accounted for $277 billion of spending growth, or 40% of the total increase in national health spending (Figure 1). The large contribution of hospital care to overall health spending growth reflects the fact that hospital spending accounted for nearly a third of national health expenditures in 2022 (30%) and grew more quickly than national health expenditures overall in both 2023 (10.6% versus 7.4%) and 2024 (8.9% versus 7.2%).”
    • FEHBlog note — Hospitals and health systems are not included in the Break Up Big Medicine bill discussed above.
  • Beckers Hospital Review tells us,
    • “Dallas-based Tenet Healthcare reported $21.3 billion in revenue in 2025, up from $20.7 billion in 2024, as the system posted strong fourth-quarter results and outlined a positive outlook for 2026. For the fourth quarter, Tenet reported net operating revenue of $5.5 billion, compared to $5.1 billion during the same period in 2024.
    • “2025 extended Tenet’s track record of strong revenue growth, disciplined operations, improved margins and robust free cash flow generation,” Tenet Chair and CEO Saum Sutaria, MD, said in a Feb. 11 news release. “We see continued demand for acute care and ambulatory surgical services in our markets and are confident in our ability to execute on our strategy and achieve our full-year 2026 expectations.”
  • and
    • “There are 417 rural hospitals that are vulnerable to closure, according to a Feb. 10 report from Chartis, a healthcare advisory services firm. 
    • “Chartis’ Rural Hospital Vulnerability Index assesses more than a dozen indicators to identify which are statistically significant for determining the likelihood of closure.
    • “The number of overall rural hospitals vulnerable is down from 432 last year, but Chartis said there are “notable shifts at the state level.” In Tennessee, the percentage of vulnerable hospitals increased from 44% to 61%. In South Dakota, the percentage increased from 28% to 42%. Mississippi, which Chartis said has long been a “weak spot in the rural health safety net,” saw an improvement from 49% to 42%. Kansas also saw an improvement from 47% to 44%. 
    • “”Chartis’ analysis found that 17 states have 10 or more rural hospitals vulnerable to closure this year. Texas has the most with 50, followed by Kansas (44), Tennessee (27), Georgia (25), and Mississippi (24). These states are receiving a combined $1.1 billion in the first round of CMS’ Rural Health Transformation Fund initiative.”  
  • BioPharma Dive informs us,
    • “Shares of Gilead Sciences slid after the stock market closed Tuesday in spite of a fresh earnings report in which the company’s top products beat Wall Street forecasts.
    • “Gilead recorded $7.9 billion in product sales over the final three months of 2025, a 5% increase from the same period a year prior. Brian Abrahams, an analyst at RBC Capital Markets, called it a “strong commercial quarter” with “major beats” in Gilead’s HIV business, which was up 6% year-over-year.
    • “Biktarvy, a three-in-one pill for HIV treatment, and Descovy, a daily tablet often used to stave off infections from the virus, respectively brought in $4 billion and $819 million during the quarter. That’s higher than the roughly $3.84 billion and $720 million the average analyst had penciled in, according to Abrahams.”
  • MedTech Dive notes,
    • “Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
    • “The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
    • “CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.”

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “Republicans on the House Judiciary Committee have subpoenaed eight insurers for documents outlining their measures to head off fraud related to Affordable Care Act subsidies.
    • “The information demands follow an attempt from the Trump administration over the summer to enact new guardrails on improper enrollments, which was paused by the courts amid ongoing litigation. The Republican committee heads said their inquiries could help unstuck that regulatory effort.: * * *
    • “The insurers who were sent a subpoena are: Blue Shield of California, Centene Corporation, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanente and Oscar Health.”
  • STAT News relates,
    • “File this under “If at first you don’t succeed…”
    • “The Trump administration is planning another attempt at creating a pilot program that would alter payments for medicines purchased through a controversial federal drug discount program.
    • “In a little-noticed posting, the Health Resources and Services Administration indicated it is pursuing a rule for a rebate model, although details were not disclosed.”
  • The American Hospital Association News tells us,
    • “The AHA Feb. 10 released its 2026 Rural Advocacy Agenda, laying out the association’s key priorities for Congress, the administration, regulatory agencies and courts. The agenda is focused on flexible payment models; ensuring fair reimbursement and access to capital; commercial insurer accountability; bolstering the workforce; and protecting the 340B Drug Pricing Program.”
  • The Washington Post informs us,
    • “The American Medical Association and a leading public health research group focused on vaccines are teaming up to create a system to review vaccine safety and effectiveness, mirroring a role long played by the Centers for Disease Control and Prevention.
    • “The groups, which will operate independently from the federal government, say their work is needed because the CDC’s vaccine review process has “effectively collapsed.” The parallel effort will initially focus on reviewing immunizations for influenza, covid-19 and respiratory syncytial virus, or RSV, ahead of the coming fall respiratory season.
    • “The groups will not be making vaccine recommendations but will provide the evidence reviews to state health officials, clinicians and others making vaccine decisions.
    • “The nation’s largest physician organization and the Vaccine Integrity Project at the University of Minnesota will convene leading medical professional societies, public health groups and health care organizations to “ensure a deliberative, evidence-driven approach to produce the data necessary to understand the risks and benefits of vaccine policy decisions for all populations — the approach traditionally used by the federal government,” according to a joint statement announcing the effort Tuesday.”

From the Food and Drug Administration front,

  • Radiology Business lets us know,
    • “A new MRI system designed specifically for imaging of neonates and infants has just been cleared by the U.S. Food and Drug Administration. 
    • “Cincinnati-based Eyas Medical Imaging announced the clearance of its Ascent3T on Thursday. Eyas cited the clearance as the first in the world for a 3T neonate-specific MRI system.  
    • “Cincinnati Children’s Hospital played a pivotal role in the scanner’s design and development. Experts there observed over 1,700 infant MRI scans on prototypes to get a better idea of how to design the system so it could achieve diagnostic quality in real-world settings.
    • “We took great care in the design of the Ascent3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” MR physicist Charles Dumoulin, PhD, a professor of pediatrics and radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging, said in an announcement.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration refused to review Moderna’s application to sell a new seasonal flu vaccine.
    • “The FDA sent Moderna a “refusal-to-file” letter earlier this month, saying the company’s study testing the vaccine wasn’t sufficient, and the agency wouldn’t take up the company’s request for approval to sell the shot, Moderna said Tuesday.
    • “In the letter, the FDA said Moderna failed during testing to compare its experimental flu vaccine to the best available vaccine on the market.
    • “Moderna said the FDA didn’t identify any concerns about the safety or effectiveness of the company’s experimental vaccine. The company said it was asking the agency for a meeting to discuss the matter.”
  • Fierce Pharma adds,
    • “A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi.”
  • Per an HHS news release,
    • “The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider whether BHA is safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information. As part of this re-assessment, the agency issued a Request for Information (RFI) on the use and safety of BHA.
    • “This is part of the FDA’s broader efforts to proactively review chemical additives in the food supply. In May 2025, the FDA launched a strengthened program to review chemicals currently in the food supply. FDA identified BHA as a top priority for review. The FDA’s post-market assessment of BHA used in food is one of several ongoing post-market assessments under the agency’s enhanced systematic process for scrutinizing chemicals in our food supply.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “There are 933 cases in the South Carolina measles outbreak, the state’s Department of Public Health reported Feb. 10. Of those, 859 cases are unvaccinated, 20 are partially vaccinated, 25 are vaccinated and the status of 29 cases is unknown. The agency said last week that in January there were more than 16,800 doses of the measles vaccine administered, a 72% increase compared to January 2025. The department said vaccination continues to be the best way to prevent measles and end the outbreak.”
  • The Wall Street Journal asks “Why Doctors Can’t Agree on How to Diagnose Alzheimer’s Disease.”
    • “Divergent diagnostic criteria is raising concerns that some patients are being misdiagnosed and unnecessarily treated.” * * *
    • “Dr. Gayatri Devi, director of Park Avenue Neurology in New York City, is a neurologist who says over the past year she has seen an increasing number of patients who were told they had Alzheimer’s disease when they didn’t. One patient, a human-resources executive, had erroneously been diagnosed with Alzheimer’s based on a faulty PET scan of his brain that had read positive for amyloid and his own fears of memory issues because he had missed an important meeting.” * * *
    • “Dr. Reisa Sperling is a neurology professor at Harvard Medical School who runs studies testing antiamyloid drugs in asymptomatic people with amyloid in their brain. She says the goal is early intervention. * * *
    • “She says the International Working Group’s criteria requiring cognitive impairment to diagnose Alzheimer’s disease is problematic, likening it to requiring someone with diabetes to wait until they have blindness or kidney failure to be diagnosed. “All disease begins before symptoms, and most diseases are better treated before people walk into your office with clear impairment,” Sperling says. 
    • “Devi says the psychological impact of being told you have Alzheimer’s when you don’t is profound. Until the medical community can better agree on how to both diagnose early Alzheimer’s disease and determine whether early treatment helps, patients should avoid unnecessary testing—especially with the advent of easily accessible blood tests.”
  • MedPage Today tells us,
    • “A large-scale, automated urinary incontinence (UI) screening and education program increased awareness, diagnosis, and treatment of the condition, researchers found.
    • “In a quality improvement study known as Identify, Teach, and Treat (IT2), Sarah Collins, MD, of the University of Chicago Pritzker School of Medicine, and colleagues asked women presenting for routine annual primary care visits a single question: “Do you have bothersome leakage of urine?”
    • “Those who answered “yes” were given the option to engage in an educational and interactive computer-based tool about UI and treatment options. Using the tool led to significant increases in practice-level rates of UI diagnosis and treatment, the researchers reported in JAMA Internal Medicine.”
  • Healio informs us
    • “Adolescents and young adults with type 1 diabetes who reported receiving help with managing their disease may have better glycemic outcomes as they transition from pediatric to adult care, researchers reported.
    • “In a study published in Diabetic Medicine, researchers analyzed baseline data from adolescents and young adults who enrolled in a randomized clinical trial to assess a behavioral intervention to support the transition from pediatric to adult care. After conducting four multiple regression models, researchers found that participants who said they received more help with managing their diabetes had better self-management skills and lower HbA1c.”
  • Per NIH news releases,
    • “National Institutes of Health (NIH) researchers have developed a digital replica of crucial eye cells, providing a new tool for studying how the cells organize themselves when they are healthy and affected by diseases. The platform opens a new door for therapeutic discovery for blinding diseases such as age-related macular degeneration (AMD), a leading cause of vision loss in people over 50.
    • “This work represents the first ever subcellular resolution digital twin of a differentiated human primary cell, demonstrating how the eye is an ideal proving ground for developing methods that could be used more generally in biomedical research,” Kapil Bharti, Ph.D., scientific director at the NIH’s National Eye Institute (NEI).”
  • and
    • “The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study ,following a regular review by the Data Safety and Monitoring Board (DSMB).
    • The DSMB is an independent group of experts that regularly check if the study is safe. NIH’s National Institute of Neurological Disorders and Stroke, the trial’s funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots.
    • All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH’s top priority.
  • Per BioPharma Dive,
    • “In experimental eczema shot from Nektar Therapeutics helped trial enrollees who’d already benefited from treatment maintain and even deepen their response over one year after being switched to a longer-lasting maintenance dose, the company said Tuesday.
    • “The data, if confirmed in additional testing, could give Nektar’s shot a competitive advantage over Regeneron and Sanofi’s Dupixent and Eli Lilly’s Ebglyss by offering deepening effects with less-frequent dosing. But Nektar also faces competition from many others advancing different types of injectables and oral medicines for the condition. 
    • “Nektar is planning a Phase 3 trial with a similar design that will allow responders to transition to a maintenance dose while others continue on with the initial regimen. If successful, the company expects to ask the Food and Drug Administration for approval in 2029.”
  • and
    • “An experimental, dual-acting weight loss pill from Hengrui Pharma and Kailera Therapeutics will advance into further testing after succeeding in a mid-stage study in China.  
    • “The drug is an oral version of ribupatide, an injectable therapy the two have already brought into Phase 3 development. In a Phase 2 study in 166 participants, that pill helped spur an average of as much as roughly 12% weight loss over 26 weeks, compared to about 2% for placebo recipients. More than half of those on the highest dose lost at least 10% of their body weight, and around 38% achieved at least 15% weight loss.
    • “Most treatment-related side effects were gastrointesinal and mild to moderate in nature. At the top two doses tested, vomiting was reported in as many as 11.4% and 7.5% of recipients, and nausea in 22.7% and 20%, respectively. Hengrui will “rapidly” move the drug into a Phase 3 trial in China, while Kailera plans to start a global mid-stage trial this year, the companies said.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS beat Wall Street’s expectations in the fourth quarter, but investors — unhappy that the healthcare giant didn’t change its outlook for 2026 — still sent CVS’ stock down after the company released results early Tuesday morning.
    • “Executives defended CVS’ 2026 guidance as achievable and indicative of the success of the company’s turnaround plan during a difficult time for insurers. The financial growth CVS outlined contrasts with some of its managed care peers, which expect revenue and earnings to contract this year.
    • “CEO David Joyner also said that CVS is in talks with the Federal Trade Commission in the agency’s high-profile lawsuit against major pharmacy benefit managers, following the FTC’s recent settlement with Cigna.” * * *
    • “Moreover, legislation passed earlier this month requiring more transparency and delinking compensation from drug prices in Medicare’s prescription drug benefit is manageable, and could lead to greater adoption of Caremark’s rebate-free model, Joyner said.
    • “What we’ve seen now is more clarity in terms of where the reform is coming from. The good news is, we know at least with the legislation how to operate and how to run our business,” Joyner said. “At least consistent with the PBM legislation, the tools that we’ve seen are essentially leaning into what we’ve been doing over the last couple years.”
  • Fierce Healthcare relates,
    • “With 2025 marking a “reset year for the industry,” Oscar Health put a focus throughout the year on setting the company up for the future, its top brass told investors Tuesday.
    • “Oscar’s insurance business is concentrated in the Affordable Care Act exchange market, and CEO Mark Bertolini said during the company’s fourth-quarter earnings call that plans across this space felt the squeeze as more Medicaid lives entered the pool and integrity measures drove changes in market dynamics.
    • “With that backdrop, Oscar priced its plans for 2026 to account for those program integrity changes, elevated utilization trends and higher morbidity among its membership, Bertolini said. He said the team also baked in an expectation that the advanced premium tax credits would run out as scheduled, which they did Jan. 1.
    • “We took decisive actions with a disciplined pricing, distribution and product strategy to go after profitable growth as competitors pulled back or exited the market,” he said.”
  • Kaufmann Hall tells us,
    • “Hospital performance settled into a “new normal” in 2025. Patient volumes continue to grow, and a persistent gap between gross and net operating revenue indicates an eroding payer mix and more uninsured patients.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Hospital performance settled into a “new normal” in 2025. While margins in 2025 were stronger compared to prior years, hospitals need to be strategic about diversifying services and managing expenses.
      • “Patient volumes continue to grow across all services. While outpatient volumes continue to increase, hospitals will likely have a greater proportion of high acuity patients with elevated costs of care.
      • “There is a persistent gap between gross and net operating revenue, alongside a rise in bad debt and charity care. This imbalance indicates an eroding payer mix, likely a higher proportion of government vs. private payers, and more uninsured patients.”
  • Beckers Hospital Review adds,
    • “The same financial pressures hospitals are facing are increasingly evident at the physician enterprise level, according to Kaufman Hall’s latest quarterly “Physician Flash Report,” which is based on data from more than 200,000 employed providers — physicians and advanced practice providers — across more than 100 specialties.
    • “Provider productivity continues to climb, even as reimbursement and compensation lag behind, according to the report. Provider productivity — measured by work relative value units per full-time equivalent — has increased 7% since 2023. Over the same period, provider compensation rose 6%, while reimbursement declined 1%, as measured by net patient revenue per provider wRVU.
    • “The imbalance is driving higher practice subsidies. 
    • “The median investment — or subsidy — per physician reached $315,358 in the fourth quarter of 2025, a 4% increase since 2023. Labor expenses also remain elevated, accounting for 84.4% of total physician practice costs.
    • “The amount of downstream revenue that a provider needs to generate to cover a practice’s investment is increasingly unsustainable in this current financial environment,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a Feb. 10 news release. “Providers are working more but are being paid less for their work. Patient demand is up, yet reimbursement is falling.”
  • Fierce Pharma points out,
    • “After ending 2025 with a strong fourth quarter, AstraZeneca management has doubled down on its ambitious “$80 billion by 2030” revenue target, outlining a roadmap to have more than 25 blockbuster medicines by the end of the decade.
    • “During AZ’s Q4 earnings call, CEO Pascal Soriot highlighted an “unprecedented catalyst-rich period.” With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AZ’s exec team used a big chunk of their time on the call taking inventory of key clinical programs.
    • “That large portfolio shows the value of diversification, again highlighting what Soriot called “low concentration risk.”
    • “It’s great to have one or two big products. [It] makes you very profitable and makes you look good,” Soriot said. “But if you lose one of those, as we’ve seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions.”
    • “AZ capped 2025 with fourth-quarter revenues of $15.5 billion, which arrived slightly above analysts’ expectations, thanks mainly to the company’s oncology portfolio.”
  • Beckers Payer Issues ranks States by share of mental health treatment facilities that accept commercial insurance.
    • “Overall, 83% of mental health treatment facilities accept private insurance in the United States. 
    • “Wyoming has the greatest percentage of centers that take commercial insurance, whereas California and the District of Columbia have the lowest. 
    • “KFF reported the rate of mental health treatment facilities that accept various insurance types, relying on 2024 data from respondents. While a facility may report participation, not all facilities may be accepting new patients.”

Monday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “The Trump administration on Monday proposed stripping the power of an independent board to review challenges from fired federal workers while barring employees from taking the matter to court.
    • “The new proposed rule would impact federal workers fired through a Reduction in Force (RIF), the process used at 22 different agencies last year as the Trump administration conducted widespread layoffs.
    • “If finalized, any federal worker fired in a future RIF would not be able to plead their case before the quasi-judicial Merit Systems Protection Board (MSPB), which last year found that some agencies had “engaged in a prohibited personnel practice” in firing the workers. 
    • “Instead, any challenges would be reviewed by the Office of Personnel Management (OPM), which last year alongside the Office of Management and Budget instructed agencies to begin RIFs.”
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) proposed regulations to lower health care costs, promote competition, and strengthen program integrity in the Federal and State-Based Health Insurance (Exchanges). The proposed Notice of Benefit and Payment Parameters for 2027 would crack down on fraud and misleading practices by agents and brokers, restore accountability for taxpayer-funded subsidies, and remove federal barriers that have limited plan innovation and driven up premiums—helping ensure coverage is more affordable and works better for consumers, taxpayers, and states.” * * *
    • “To review the proposed rule, visit https://www.federalregister.gov/d/2026-02769. 
    • “Public comments must be submitted by March 11, 2026. 
    • “To review the proposed rule fact sheet, visit https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-payment-parameters-2027-proposed-rule.” 
  • Bloomberg Law adds,
    • “The Notice of Benefit and Payment Parameters from the Centers for Medicare & Medicaid Services would allow certain plans that offer preset dollar amounts for care—such as indemnity plans—to meet the requirements of a “qualified health plan” under the ACA if they demonstrate a sufficient number of doctors would accept the plan’s payment terms.” * * *
    • “The rule likewise expands hardship exemptions to permit more individuals to buy “catastrophic” plans with the lowest level of cost-sharing and coverage, and allows catastrophic plan issuers to offer multi-year terms. The proposal would also permit plans with low deductibles and higher out-of-pocket costs
    • “The rule also reverses changes made under the Biden administration, including requiring insurers to offer standardized plan options that were meant to simplify choices.”
  • Healio observes,
    • “A voluntary program designed to help Medicare Part D beneficiaries manage drug costs[, which took effect last year,] could provide considerable benefit to people with cancer, according to study results.
    • “The Medicare Prescription Payment Plan (M3P) provides flexibility that may ease financial distress — particularly for those with limited or fixed incomes — and reduce the potential for cost-related treatment nonadherence, researchers concluded.”
    • “However, many patients and health care professionals are unaware of the program, according to Aryana Sepassi, PharmD, MAS, assistant professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
    • “After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
    • “The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.”
  • MedPage Today tells us,
    • “Oncology specialists should inform patients about a risk of serious toxicity related to dihydropyrimidine dehydrogenase (DPD) deficiency and should test for DPYD variants before starting treatment with capecitabine (Xeloda) and fluorouracil, the FDA announced.
    • “In a safety update communicationopens in a new tab or window, the agency noted that DPYD encodes DPD, which breaks down more than 80% of fluorouracil. Certain homozygous or compound heterozygous DPYD variants result in complete or near-complete absence of DPD activity, increasing the risk for serious, potentially fatal toxicities when exposed to capecitabine or fluorouracil, which are widely used in cancer treatment. Potential adverse reactions include mucositis, diarrhea, neutropenia, and neurotoxicity. The reactions also can occur in patients who have partial DPD activity.
    • “Capecitabine and fluorouracil, or 5-FU, are routinely used in treatment regimens for breast, colorectal, gastric, and pancreatic cancers.”
  • STAT New informs us,
    • “The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. 
    • “The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments.”
    • “Regenxbio had applied for accelerated approval, a type of conditional market clearance, based on RGX-121’s ability to significantly reduce in the short term a specific biomarker in cerebrospinal fluid believed to correlate with longer-term cognitive improvements in patients with the severe form of Hunter syndrome. 
    • “But the FDA, in its letter rejecting the therapy, raised questions about the appropriateness of using the surrogate biomarker, called CSF HS D2S6, as a predictor of clinical benefit. The agency also questioned the eligibility criteria  Regenxbio used to enroll patients into its clinical trial and the use of a natural history comparator arm, the company said.”  

From the judicial front,

  • Bloomberg Law reports,
    • “Medical providers are testing a new legal strategy to recoup unpaid arbitration awards as health insurers rack up victories in surprise billing disputes.
    • “The shift underscores the difficulties both sides face in arbitration under the No Surprises Act, which requires doctors and insurers to settle most unexpected out-of-network bills themselves rather than balance-billing the patient. The volume of disputes has exposed cracks in the system, leading to a series of lawsuits around ineligible claims, fraud, and unpaid awards.
    • “Courts have largely concluded that the law doesn’t grant doctors the right to sue over unpaid awards in most circumstances. Most recently, the US Supreme Court denied two air ambulance companies’ petition to hear their case after the US Court of Appeals for the Fifth Circuit ruled against them.
    • “Providers are now adapting their legal strategy by arguing insurance companies are guilty of improper denial of benefits under the Employee Retirement Income Security Act and unjust enrichment under common law. Hundreds of cases in the US District Court for the District of New Jersey were paused last month pending a decision on the amended claims in Rowe Plastic Surgery of NJ LLC v. Aetna Life Insurance Co .
    • “But the doctors are likely to face problems, at least in overcoming ERISA preemption on their unjust enrichment claims, said Leslie Howard, co-founder of Cohen Howard, a firm representing out-of-network providers.”
  • The American Hospital Association News relates,
    • “The 5th U.S. Circuit Court of Appeals Feb. 9 affirmed a district court ruling upholding Louisiana’s 340B contract pharmacy law. The state law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. Three drug companies — AbbVie, PhRMA and AstraZeneca — challenged the law, arguing that it was unconstitutional in several ways. “Rejecting those arguments, the appeals court held that Louisiana’s law was not preempted by federal law, did not violate the Fifth Amendment’s Takings Clause, did not violate the Constitution’s Contract Clause and was not unconstitutionally vague. “States regulate pharmacies — and the distribution of drugs to those pharmacies — every day,” the 5th Circuit explained. “Act 358 fits comfortably within that tradition.
    • “The AHA filed friend-of-the-court briefs supporting Louisiana’s law last year.” 
  • The Society for Human Resource Management notes,
    • “On Feb. 6, a federal appeals court vacated a preliminary injunction of two executive orders (EO) — EO 14151 on “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173 on “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — finding they were not unconstitutional on their face. The court had previously stayed the injunction, pending appeal. This ruling was the first by a federal appeals court to find the two EOs facially constitutional. Both EOs focused on infrastructure inside the federal government with an emphasis on contracts and grants.
    • “EO 14173, issued Jan. 21, 2025, “was the most significant EO for the private sector” last year, said W. John Lee, an attorney with Morgan Lewis in Philadelphia. Established on May 19, 2025, the U.S. Department of Justice’s Civil Rights Fraud Initiative “is a direct result of the EO and is a prominent example of how it is reshaping federal enforcement of civil rights law.” EO 14151, issued Jan. 20, 2025, set the tone for EO 14173. EO 14173 reshaped compliance obligations for federal contractors and grantees. It also revoked EO 11246, ending EO-based affirmative action programs for women and minorities.
    • “On Jan. 21, 2025, U.S. Equal Employment Opportunity Commission (EEOC) Chair Andrea Lucas made it clear that the EEOC’s enforcement priorities had shifted in alignment with President Donald Trump’s EOs.
    • “While the 4th U.S. Circuit Court of Appeals vacated the injunction, it sent the case back to the district court for further proceedings and left open the possibility of challenges based on individual application of the EOs.”
  • The Wall Street Journal points out,
    • “A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become.
    • “In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hersof violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines.
    • “The pill from Hims & Hers threatened to undermine Novo Nordisk’s efforts to recapture momentum in the $70 billion weight-loss drug market by providing a lower-cost alternative to a Wegovy pill the Danish company recently launched.
    • “Novo Nordisk has been pulling out the stops to reclaim the momentum it lost to Eli Lilly in the booming market.” 

From the public health and medical / Rx research front,

  • Health Day tells us,
    • “Americans could be facing an uphill battle when it comes to protecting their heart health as they age, a new Cleveland Clinic poll reveals.
    • “Nearly 3 of 4 Americans (72%) feel confident in their ability to maintain heart health as they age, the survey found.
    • “But nearly as many (69%) also report that they have at least one known risk factor for heart disease.
    • “Worse, nearly 1 in 4 (24%) aren’t sure whether they are at increased risk for heart disease, according to the survey.
    • “Healthy aging is about prevention,” said Dr. Samir Kapadia, chair of cardiovascular medicine at the Cleveland Clinic.
    • “Heart disease often develops silently over decades, which is why staying active, understanding your risk factors, and addressing them early can make a profound difference in both quality of life and longevity,” Kapadia said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about the shingles virus.”
    • “If you’ve ever had chickenpox, then the virus that causes shingles is present in your body and can resurface at some point in the future. Find out more.”
  • The New York Times relates,
    • “If you think your daily doses of espresso or Earl Grey sharpen your mind, you just might be right, new science suggests.
    • “A large new study provides evidence of cognitive benefits from coffee and tea — if it’s caffeinated and consumed in moderation: two to three cups of coffee or one to two cups of tea daily.
    • “People who drank that amount for decades had lower chances of developing dementia than people who drank little or no caffeine, the researchers reported. They followed 131,821 participants for up to 43 years.
    • “This is a very large, rigorous study conducted long term among men and women that shows that drinking two or three cups of coffee per day is associated with reduced risk of dementia,” said Aladdin Shadyab, an associate professor of public health and medicine at the University of California, San Diego, who wasn’t involved in the study.”
  • NBC News relates,
    • “Bad,” or LDL, cholesterol is a major risk factor for heart disease and most people are screened for it as part of their yearly physicals.
    • There’s another marker in the blood that may be a better predictor of heart disease risk, a recent large review suggests. But it’s not part of routine blood testing.
    • “Apolipoprotein B (apoB) is a protein that attaches to harmful fat particles in the blood. The apoB protein is found on the surface of harmful lipoproteins like low density lipoprotein, or LDL, that contribute to heart disease. Since each one of the harmful particles contains one apoB molecule, testing for it essentially captures the overall number of harmful plaque-producing compounds.” * * *
    • “ApoB testing is hot among health influencers and increasingly touted in the commercial blood testing market. Recently, the Sweetgreen salad chain — which has tied itself to anti-seed-oil influencers — launched a collaboration with the testing company Function Health and is promoting apoB screening along with its menus.
    • “Dr. Michael Shapiro, a preventive cardiologist and the chair of the American Heart Association Council on Lipidology, Lipoprotein, Metabolism & Thrombosis, said that he typically uses an apoB test in select patients.” * * *
    • “In some cases, insurance may cover the test. If not, it typically costs around $70 at a lab.
    • “There aren’t clear guidelines for what target apoB levels should be. In healthy people, apoB values less than 90 mg/dL are typically considered acceptable, with some saying lower targets closer to 70 mg/dL may be more optimal for preventing heart disease.”
  • MedPage calls attention to
    • “Most women said they preferred clinic-based cervical cancer testing over at-home self-sampling, with demographics and life experiences shaping those preferences, a cross-sectional study indicated.
    • “In a nationally representative survey, 20.4% of women said they would prefer to do their own at-home self-sampling for cervical cancer screening, while 60.8% said they prefer clinic-based testing and 18.8% said they were uncertain on their preference, reported Sanjay Shete, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA.
    • “The survey showed that women who had experienced prejudice or discrimination while receiving medical care had higher odds of preferring self-sampling at home (adjusted OR 1.94, 95% CI 1.16-3.22), while Black women had lower odds of preferring at-home self-sampling compared with their white peers (aOR 0.45, 95% CI 0.21-0.96).
    • “When women were asked why they preferred at-home self-sampling, privacy was the most common reason (54.9%), followed by time constraints (35.1%) and fear of embarrassment (33.4%).”
  • and
    • “The CDC’s Advisory Committee on Immunization Practices recently voted to stop recommending a universal dose of the hepatitis B vaccine at birth.
    • “An evidence review found that universal hepatitis B vaccination at birth is safe, effective, and protective for individual and public health.
    • “There was no improvement in safety or effectiveness with a delayed first dose of the hepatitis B vaccine.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a study using gut microbiome samples from over 11,000 people across 39 countries, a single group of bacteria (CAG-170) has been found in higher numbers in the gut microbiomes of healthy people. CAG-170 remain unculturable in the lab, and are only identifiable from their genetic fingerprints.
    • “Further analysis of CAG-170 revealed the bacteria have the capacity to produce high levels of Vitamin B12 and enzymes that break down a wide range of carbohydrates, sugars, and fibers in our gut. The researchers suggest that Vitamin B12 supports other species of gut bacteria, rather than supporting the humans whose guts it is being produced in. CAG-170 could, in the future, be used as an indicator of our gut microbiome health or serve as the basis for the development of probiotics specifically designed to support and maintain healthy levels of CAG‑170 in the gut.”
  • Per Cardiovascular Business,
    • “An oral PCSK9 inhibitor from Merck is associated with significant reductions in low-density lipoprotein (LDL) cholesterol, according to new data published in The New England Journal of Medicine.[1] All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a major impact on patient care. 
    • “Fewer than half of patients with established atherosclerotic cardiovascular disease currently reach LDL cholesterol goals,” lead author Ann Marie Navar, MD, PhD, an associate professor of cardiology at the University of Texas Southwestern Medical Center in Dallas, said in a statement. “An oral therapy this effective has the potential to dramatically improve our ability to prevent heart attacks and strokes on a population level.”
    • “Back in November, researchers presented initial findings from this study at the American Heart Association’s Scientific Sessions 2025 conference. Now, however, the analysis can be read in full.
    • “The CORALreef Lipids trial focused on nearly 3,000 heart patients with high LDL cholesterol who were randomized to either receive enlicitide, Merck’s experimental oral PCSK9 inhibitor, or a placebo. Two patients received the new drug for every one patient treated with a placebo.”
  • Per Radiology Business,
    • “A new MRI-specific artificial intelligence tool could significantly improve the diagnosis of neurological conditions in busy settings. 
    • “Developed by researchers at the University of Michigan, the tool can read brain scans in just seconds. The tool, named Prima, is a video language model that can simultaneously process video, images and text in real time. Experts involved in its development are hopeful it can help address the rising imaging volumes.
    • “As the global demand for MRI rises and places significant strain on our physicians and health systems, our AI model has potential to reduce burden by improving diagnosis and treatment with fast, accurate information,” said senior study author Todd Hollon, MD, a neurosurgeon at U-M Health. 
    • “Researchers trained Prima using more than 200,000 MRI exams collected at the university over several decades. Imaging data were included alongside patients’ medical histories and clinical indications for the scans. The team tested the model on more than 30,000 brain studies over a one-year period. Unlike earlier AI tools that focus on just one disease, Prima was designed to analyze all available imaging and clinical information at once, similar to how a radiologist reviews a case, giving it broad applicability.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Kaiser Permanente nearly tripled its operating income last year, even as the integrated healthcare conglomerate weathered rising expenses.
    • “Kaiser, which recorded results alongside its subsidiary Risant Health, recorded operating income of $1.4 billion last year, up from $569 million in 2024 as the nonprofit continued to invest in operational improvements, according to earnings results released last week. 
    • “Still, expenses rose by more than $11 billion last year as Kaiser said rising medication costs and other line items made providing care more expensive.”
  • Beckers Hospital Reviews identifies eleven rapidly growing health systems.
  • BioPharma Dive relates,
    • “Eli Lilly will acquire biotechnology startup Orna Therapeutics, saying Monday it will pay up to $2.4 billion to buy the privately owned company and a technology able to reprogram immune cells within the body.
    • “The Indiana-based drugmaker didn’t disclose how much upfront cash it’s shelling out for Orna, which specializes in “circular” RNA medicines that are believed to be more stable and easier to pair with the lipid nanoparticles used for delivery. But it noted in its statement that it intends to use Orna’s technology to develop cell therapies for autoimmune conditions.
    • “In announcing the deal, Lilly cited its interest in Orna’s lead project, which instructs immune cells to latch onto B cells that are attacking patients’ tissue in inflammatory diseases. The company presented data from preclinical studies at the American Society for Hematologymeeting in December that it’s using to support advancing into Phase 1 studies.”
  • and
    • “Japan’s largest drug company is teaming up with an artificial intelligence specialist to find new medicines for cancer and other diseases, through a deal that could be worth more than $1.7 billion.
    • “Announced Monday, the multiyear collaboration grants Takeda Pharmaceutical access to two technologies at Iambic Therapeutics. The first is an AI-driven platform used to discover and develop new drugs. The second is a model meant to predict how proteins will interact with certain receptors.
    • “The companies haven’t disclosed the deal’s upfront cost, nor any specific disease targets. The focus, though, will be on small molecule drugs for cancers and conditions rooted in the digestive or immune systems. Iambic will get milestone payments based on the partnership’s level of success, and is also eligible to receive royalties on net sales of any products it generates.”
  • Per Beckers Payer Issues,
    • “Patients who take advantage of zero-cost preventive screenings see better health outcomes and reduced spending, according to January research from BCBS Association and Blue Health Intelligence.
    • “The groups reviewed claims data of BCBS members with breast or colorectal cancer. The research pointed to lower likelihood of invasive tests and treatment.
    • “Eighty-one percent of members who were diagnosed with colorectal cancer through a preventive screening were classified in an early stage, compared to a 73% rate overall. For breast cancer, that figure was 86% during preventive screening. The early-stage rate was 82% overall.” 
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.”

Weekend update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–

Happy Super Bowl Sunday!

  • The House Energy Commerce Committee health subcommittee holds a hearing on February 11 with Pharma and PBM executives.
  • Fierce Healthcare adds,
    • “In the $1.2 trillion budget package signed Tuesday, a little-known healthcare provision was reauthorized that will allow millions of people on Medicare to access diabetes prevention education online. 
    • “As part of the budget package, Congress passed the PREVENT DIABETES Act, which extends the ability for digital health companies (virtual suppliers) to participate in the Medicare Diabetes Prevention Program (MDPP) through the end of 2029. 
    • “Medicare Part B patients who are at risk for Type 2 diabetes can participate in the program for free, if they meet certain clinical thresholds for weight, blood pressure or blood glucose. The program lasts for a year and consists of 22 sessions on lifestyle changes to prevent diabetes. 
    • “Since the COVID-19 pandemic, virtual providers like Omada Health, 9am Health and Amwell have entered the business on temporary authority, much like other Medicare telehealth services.” 
  • Under the budget package, the Homeland Security appropriations bill remains under a continuing resolution which expires on February 13.
  • Roll Call lets us know,
    • “With no signs of tangible progress in negotiations over changes to immigration enforcement policies, the main question may be whether House members and senators can muster the votes needed for another short-term funding extension just for DHS.
    • “Both chambers of Congress are expected to be on recess next week for Presidents Day. The holiday weekend overlaps with the annual Munich Security Conference, which runs Feb. 13-15 and typically attracts a large congressional delegation.
    • “Senate Majority Leader John Thune, R-S.D., who is not traveling to Munich this week, suggested the Senate may need to be in session if the Homeland Security funding is not resolved.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight loss pill following backlash from U.S. regulators and the threat of a federal investigation. 
    • “In a short statement posted on the social media platform X Saturday, Hims said that, after “constructive conversations with stakeholders across the industry,” it “decided to stop offering access” to the treatment. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.” 
    • “The sudden turn quickly ends, for now, plans by the telehealth company to launch a copycat form of Novo’s “Wegovy” pill. Hims had announced those plans on Thursday and, in doing so, quickly drew legal threats from Novo as well as swift action from the Food and Drug Administration.” 

From the public health and medical / Rx research front,

  • Clinical Advisor reports,
    • “Measles is now extending beyond families with young children, with outbreaks reported on college campuses and communities across the country.
    • “At least 12 people have tested positive for measles at Ave Maria University in Florida, near Naples, since January 29, according to local officials. Three people were taken to the hospital.
    • “A student at the University of Wisconsin-Madison also tested positive after traveling overseas.
    • “Earlier this year, Clemson University in South Carolina confirmed a measles case linked to someone with ties to the school.
    • “It takes only 3 cases of measles for health officials to declare an outbreak.
    • “So far in 2026, at least 17 states have reported infections, according to the US Centers for Disease Control and Prevention (CDC).”
  • CNN tells us,
    • “We often discuss depression and dementia separately, although scientists have long observed a connection between the two: People with depression appear to have a higher likelihood of developing dementia later in life.
    • “A new study published in The Lancet Psychiatry adds an important twistin untangling that relationship and looks beyond depression as a single diagnosis. By focusing on specific symptoms, the research raises a more precise and potentially more useful question: Could certain symptoms in midlife signal greater vulnerability to dementia decades later? And if so, what should people and clinicians do with that information now?”
    • The CNN reporter interviews CNN wellness expert Dr. Leana Wen about the study.
  • Medscape informs us,
    • “As GLP-1s continue to surge in demand, older patients in your practice may inquire about these medications for their weight-loss efforts. Although they are known to improve conditions such as high cholesterol and obesity and help with the management of type 2 diabetes, certain precautions should be considered for patients older than 65 years.
    • “Older adults often do their own research on wellness trends. If they ask about GLP-1 medications, knowing clinical and science-based facts can keep them informed and safe. Some experts say these medications and this patient population should be carefully considered.
    • “[In the article,] Yuval Pinto, MD, DABOM, assistant professor of medicine and part of the Healthful Eating, Activity & Weight Program at Johns Hopkins School of Medicine in Baltimore, laid out some of the risks.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Two years ago, a GLP-1 prescription could cost an uninsured patient more than $1,000 a month. Today, Novo Nordisk’s NOVO.B Wegovy pill starts at just $149 through cash-pay programs. 
    • “In the world of Big Pharma, this is unheard of. 
    • “Typically, drug prices climb or plateau until generics arrive years later. That trend should be even stickier in a duopoly. Yet the obesity market has turned traditional pharma economics upside down. As Leerink analyst David Risinger notes, there isn’t a comparable precedent for this level of price erosion in the industry’s history.” * * *
    • The question both companies [Novo and Lilly] are now racing to answer is just how elastic consumer demand is in the obesity market. Lower prices are clearly unlocking growth in demand, especially in the cash-pay market. As Novo Nordisk Chief Financial Officer Karsten Munk Knudsen argued in an interview this week, this isn’t a price war, so much as a search for the price points that open the floodgates of access.
  • The New York Times lets us know “How to Tell if You Will Save Money Using TrumpRx.”
    • “People may be able to pay less for prescriptions with their insurance rather than via the new government website. The Trump drugstore is meant to help people buy medications using their own money.”
  • Beckers Payer Issues notes,
    • “Elevance Health bid on 11 national accounts in competing Blue Cross Blue Shield markets last year and won nine of them, the company said on its 2025 earnings call with investors, offering the first look at how a landmark antitrust settlement is reshaping competition within the Blues ecosystem.
    • “This is the first year that we’ve had the opportunity for employers in competing geographies against us who could actually quote with our organization if they wanted,” Morgan Kendrick, Elevance’s president of commercial and specialty health benefits, said Jan. 28.
    • “The provision, known as the “second blue bid,” stems from a $2.67 billion settlement that resolved allegations dating back to 2012 that BCBS companies conspired to divide up markets and avoid competing with one another, thereby driving up costs for consumers. Among other changes, the settlement struck down a rule that required large employers to work with the BCBS insurer covering the geography where the employer is headquartered.
    • “Now, for certain large national accounts, employers can solicit bids from any BCBS plan in the country, not just the one licensed in their service area. Elevance’s 9-for-11 record is the first concrete data point on how the settlement is reshaping competition among Blues plans, but industry observers say the effects could stretch beyond one selling season.
    • “Ari Gottlieb, a consultant to insurers and owner of A2 Strategy, told Becker’s the provision will primarily benefit BCBS plans with the existing scale and technology to compete nationally.”

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Govexec reports,
    • “The House Oversight and Reform Committee on Wednesday unanimously advanced legislation aimed at updating the federal government’s buyout programs to encourage employees to leave.
    • “Voluntary Separation Incentive Payments are one of the government’s main tools for reducing agency headcounts, alongside Voluntary Early Retirement Authority and reductions in force. But VSIP offerings max out at $25,000, where the cap has sat since the 1990s.
    • “The Federal Workforce Early Separation Incentives Act (H.R. 7256), introduced by Rep. Nick Langworthy, R-N.Y., would remove the $25,000 hard cap on VSIP payments and replace it with a maximum of six months of a federal worker’s salary, subject to agency head approval. The new model is based off how federal agencies already calculate severance pay for laid-off feds.
    • ‘Langworthy said an update to the federal government’s buyout program was long-overdue, and that the changes will allow agencies to move more agilely—and humanely—in workforce planning.”
  • The Wall Street Journal relates,
    • “The Trump administration is planning to make it easier to discipline—and potentially fire—career officials in senior positions across the government, a move that would affect roughly 50,000 federal workers. 
    • “The U.S. Office of Personnel Management, which oversees the federal workforce, issued a final rule on Thursday that creates a category of worker for high-ranking career employees whose work focuses on executing the administration’s policies. Workers who fall into that category would no longer be subject to rules that for decades have set a high bar for firing federal employees.
    • “While political appointees at agencies are considered at-will employees who serve at the discretion of the president, career employees have long enjoyed strong job protections, including the ability to appeal firings, suspensions, or disciplinary action to an independent board. Workers that fall under the new category wouldn’t be able to appeal to the board.”
  • An OPM news release adds,
    • “The final rule was published for public inspection in the Federal Register on February 5, 2026, and will take effect 30 days after publication. Following the rule’s effective date, specific positions may be placed in Schedule Policy/Career by presidential executive order. Read Director Kupor’s blog post on the rule here.”
  • Tammy Flanagan, writing in Govexec, points out “the federal leave options employees can use when annual and sick time run out.”
    • “From unpaid leave to parental and military leave, federal workers have multiple options for time off under specific circumstances.”
  • STAT News informs us,
    • “President Trump on Thursday night is planning to announce the launch of TrumpRx, the website that he and his aides have touted for months as a platform aimed at lowering prescription drug prices. 
    • “The website, which uses technology from health care company GoodRx, is expected to display the cash prices — that is, the prices available when paying without insurance — for certain drugs and direct patients to other sites where they can buy the therapies. It’s part of Trump’s plan to lower drug prices in the U.S., but some experts are skeptical the platform will meaningfully affect affordability.” * * *
    • “TrumpRx will not sell medications. It is expected to be a searchable website that links to other sites through which patients can directly buy brand drugs. That might be a drug company’s own website, such as Eli Lilly’s LillyDirect or Novo Nordisk’s NovoCare Pharmacy, or an online pharmacy that partners with a drugmaker, such as Amazon Pharmacy and Truepill.”
  • The American Hospital Association News notes,
    • “The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology announced the selection of nine pilots as part of the Behavioral Health Information Technology Initiative to help improve behavioral health data exchange across care settings. The BHIT Initiative is a $20 million effort led by ASTP/ONC in coordination with the Substance Abuse and Mental Health Services Administration to support standard data elements and foster data exchange. The pilots, which will be completed by the end of this year, will be used to inform future standards, technical specifications, guidance and policy considerations. The pilots span across 45 exchange partners and eight states and Washington, D.C. The states are Colorado, Connecticut, Delaware, Florida, Massachusetts, North Carolina, Oregon and Rhode Island.”
  • Healthcare Dive calls our attention to the fact
    • “More than one-fourth of doctors enrolled in Medicaid didn’t actually deliver care to any Medicaid beneficiaries in 2021, according to new research adding to worries about low physician participation in the safety-net insurance program.
    • “Almost 28% of doctors enrolled in Medicaid were “ghost providers” and didn’t treat a single patient that year, the study published in Health Affairs on Monday found. Another 10% treated fewer than 10 patients, while the remaining 62.2% were standard or “core” providers treating the brunt of Medicaid enrollees.
    • “Participation varied widely by specialty, with psychiatrists most likely to be ghost providers and primary care physicians and cardiologists least likely to be ghost providers, the study found.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The nation’s top drug regulator said he wants to do away with pharmaceutical ads that employ “dancing patients, glowing smiles, and catchy jingles that drown out the fine print.” On Super Bowl Sunday, the drug industry will treat him to lounging football stars, a shouting DJ Khaled, and the soothing tones of Enya.
    • “Sunday’s game, the annual zenith of American advertising, is the first since Food and Drug Administration Commissioner Marty Makary began a self-described “crackdown” on drug marketing last year. And, based on the ads released in advance, little has changed in the eyes of the industry.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources. Companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. In the past, companies were generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise.
    • “The agency sent a letter to industry providing notice of the FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Chronic exposure to pollution from wildfires has been linked to tens of thousands of deaths annually in the United States, according to a new study. 
    • “The paper, published Wednesday in the journal Science Advances, found that from 2006 to 2020, long-term exposure to tiny particulates from wildfire smoke contributed to an average of 24,100 deaths a year in the lower 48 states.
    • “Our message is: Wildfire smoke is very dangerous. It is an increasing threat to human health,” said Yaguang Wei, a study author and assistant professor in the department of environmental medicine at Icahn School of Medicine at Mount Sinai. 
    • “Other scientists who have studied the death toll from wildfire smoke were not surprised by the findings. 
    • “The estimates they’re coming up with are reasonable,” said Michael Jerrett, professor of environmental health science at the University of California, Los Angeles who was not involved in the study. “We need more of them. It’s only if we’re doing multiple studies with many different designs that we gain scientific confidence of our outcomes.”
  • Bloomberg Law tells us,
    • “Chris Womack is one of a dwindling number of Texas ranchers who can remember fighting the New World screwworm, a once-vanquished pest threatening to make an unwanted encore in the US after its recent return to northern Mexico. 
    • “You never forget the smell,” Womack, 60, said of his first encounter with a calf being devoured by screwworm maggots. It was one of many he and his father would treat in the early 1970s as an outbreak of the parasite — which can kill cattle in less than two weeks — devastated Texas ranchers.
    • “More than 50 years later, Womack and other Texas cattlemen are bracing for the screwworm’s potential comeback. Cases are proliferating in a Mexican state that borders Texas, with the pest having escaped containment by an international eradication program that banished it for decades. Texas Governor Greg Abbott issued a disaster declaration last week to open up state resources for the screwworm response.
    • “The pest’s resurgence would squeeze the $130 billion US cattle industry, which is already struggling with a record-low herd and rising costs. The screwworm prompted the US to ban cattle imports from Mexico for much of the last 14 months, crimping American beef producers at a time when record prices for the meat are adding to the pressure on shoppers angry about the cost of food.”
  • MedPage Today lets us know,
    • “New research challenged the longstanding belief that autism is much more common in males versus females.
    • “In a Swedish study of 2.7 million people, male-to-female ratios in autism diagnoses were nearly equal by age 20.
    • “Diagnosis rates peaked earlier for males, but females experienced a significant catch-up in adolescence.”
  • Genetic Engineering and BioTechnology News relates,
    • “Some types of CD8+ T cells (killer T cells) may play a role in the development of multiple sclerosis (MS). This is according to data from a new study published in Nature Immunology. Specifically, scientists found specific T cells that are abundant in people with MS, which also target the Epstein-Barr virus (EBV). They suggest that this points to a possible role for the virus in triggering the immune response seen in the autoimmune disease.   
    • “Full details are published in a paper titled “Antigen specificity of clonally enriched CD8+ T cells in multiple sclerosis.” For Joe Sabatino, MD, PhD, senior author on the study and an assistant professor of neurology at University of California, San Francisco’s Weill Institute for Neurosciences, “these understudied CD8+ T cells [connect] a lot of different dots.” That is because scientists have known for several years that EBV, a common virus carried by about 95 percent of adults, is present in virtually everyone who develops MS. This data “gives us a new window on how EBV is likely contributing to this disease,” he said.” 
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian cut the relative likelihood of a repeat stroke by 26% without increasing the risk of internal bleeding, the company said Thursday, boosting hopes that the company might become a new option for “secondary treatment” of the disorder.
    • “The news could also elevate the outlook for medicines like asundexian, which are called Factor XIa inhibitors and are being advanced by a handful of the world’s largest pharmaceutical companies.
    • “Members of that drug class, including asundexian and a similar therapy from Bristol Myers Squibb and Johnson & Johnson, have previously suffered clinical setbacks in different types of cardiovascular illnesses. But asundexian’s success, first announced in November, lifted Bayer shares and indicated the drugs might be able to fulfill at least some of their commercial potential.
    • “The German drugmaker released full data from its positive study, “Oceanic-Stroke,” at the International Stroke Conference in New Orleans on Thursday.” 
  • Per the AP,
    • “A new kind of pill sharply reduced artery-clogging cholesterol in people who remain at high risk of heart attacks despite taking statins, researchers reported Wednesday.
    • “It’s still experimental but the pill helps rid the body of cholesterol in a way that today can be done only with injected medicines. If approved by the Food and Drug Administration, the pill, named enlicitide, could offer an easier-to-use option for millions of people.
    • “Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even taking the highest doses, many people need additional help lowering their LDL, or “bad,” cholesterol enough to meet medical guidelines.
    • “In a major study, more than 2,900 high-risk patients were randomly assigned to add a daily enlicitide pill or a dummy drug to their standard treatment. The enlicitide users saw their LDL cholesterol drop by as much as 60% over six months, researchers reported in the New England Journal of Medicine.”

From the U.S. healthcare business and artificial intelligence front,

  • Healthcare Dive reports,
    • “Cigna posted fourth quarter 2025 results Thursday morning that outperformed analysts’ consensus expectations, with adjusted revenue of $72.5 billion up more than 10% and adjusted operational income of $2.1 billion up 16%.
    • “Cigna Healthcare, the company’s insurance division, saw its revenue drop 16% in the quarter due to the sale of its Medicare Advantage business to Health Care Service Corporation. Cigna Healthcare’s operational income rose 44% year over year, however, after the company jacked up premiums for its stop-loss products after seeing those costs spike in the fourth quarter of 2024.
    • “But the lion’s share of attention on Thursday morning’s call was devoted to Express Scripts, and how the FTC settlement might impact the massive PBM’s profits.
    • “Short answer? It won’t, executives said.”
  • BioPharma Dive relates
    • “Hims & Hers Health is launching a copycat form of Novo Nordisk’s newly launched obesity pill, ushering in the latest contentious battle between the makers of branded weight loss medications and their drug-compounding counterparts. 
    • “Hims said Thursday that it’s now enabling healthcare providers to prescribe a compounded pill with the same active ingredient, semaglutide, as Novo Nordisk’s oral Wegovy. That treatment will be sold as part of treatment plans that begin at $49 for the first month — $100 lower than the price Novo is charging under a deal with the Trump administration. Hims also claimed that its treatment is formulated differently and involves a different delivery method to protect the active ingredient during digestion. 
    • “In a statement issued in response to Hims’ announcement, Novo spokesperson Ambre James-Brown called Hims’ move “illegal mass compounding and deceptive advertising” and threatened litigation. The compounder is “unlawfully” mass-marketing an “unapproved, inauthentic, and untested knockoff” of Novo’s medication, she said.” 
  • Modern Healthcare tells us,
    • “Adtalem Global Education has become Covista, the Chicago-based education company said, with a plan to expand its healthcare career network.
    • “Covista serves nearly 100,000 students and has a community of 385,000 alumni across its five accredited institutions.
    • “Covista touts it puts 24,000 new professionals annually into the healthcare workforce — more than any other U.S. institution — including 10% of America’s new nurses.”
  • Beckers Payer Issues lets us know,
    • “Participating Medicare Part D plans can officially begin covering weight-loss treatment in 2027. 
    • “The initiative falls under CMS’ voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model. The December news followed President Trump’s negotiations with Eli Lilly and Novo Nordisk to secure most-favored-nation pricing for drugs that treat obesity, diabetes and related conditions.
    • “To better understand Medicare usage and spending shifts, KFF analyzed CMS data from 2019 through 2024 [as discussed in the article].
  • and
    • “Here are 12 payer tools that achieved “Best in KLAS” recognition for 2026:
      • “Care management solutions: Cognizant (TriZetto CareAdvance Enterprise) 
      • “Claims & administration platforms: Cognizant (TriZetto Core Claims/Administration Solutions)
      • “CMS payer interoperability: Edifecs (XEngine Server for FHIR)
      • “Data analytics platforms: Innovaccer (Healthcare Data Platform)
      • “Payer/provider data exchange: Moxe (Digital ROI)
      • “Post-payment accuracy & integrity solutions: Trend Health Partners (TRENDConnect) 
      • “Pre-payment accuracy & integrity solutions: HealthEdge (Source)
      • ‘Quality measurement & reporting: Inovalon (Converged Quality) 
      • “Risk adjustment (coding, retrieval & compliance solutions): Datavant (Risk Adjustment Suite)
      • “Risk adjustment (POC & in-home health assessments): Cozeva (PayerOne Risk)
      • “IT consulting services: Huron
      • “Employer-sponsored healthcare services: Premise Health
    • “The full report is accessible from KLAS Research here.“
  • Per Beckers Hospital Review,
    • “Chicago-based CommonSpirit Health now has 242 artificial intelligence applications live across its hospitals, up from 230 last year.
    • “We are expanding our use of AI across CommonSpirit by deploying new capabilities and scaling the most impactful of our existing tools,” CIO Daniel Barchi told Becker’s.
    • “In 2025, the health system generated more than $100 million in annual savings through its use of AI and robotic process automation tools across multiple areas of the organization. Mr. Barchi said the value generated in fiscal year 2026 is expected to exceed last year’s total.
    • “More important than the financial impact is the expanded clinical and operational value we are seeing from these tools — value that is not measured only in dollars,” he said. “Our sepsis surveillance tool has contributed to continued reductions in sepsis-related mortality. Screening tools for colon and breast cancer are helping us identify high-risk patients, leading to thousands of additional screenings. AI tools for imaging are reducing scan times by up to 50%, supporting a better experience for patients and providers.”
    • “As CommonSpirit expands its AI footprint, Mr. Barchi said the health system has also declined or scaled back AI tools that failed to deliver expected value.”

Midweek report

David Ermer–ACA, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Senate negotiators said an effort to renew expired healthcare subsidies had effectively collapsed, likely ending the hopes of 20 million Americans that the tax-credit expansion could be revived and lower their monthly insurance premiums.
    • “Talks had centered on a proposal from Sens. Bernie Moreno (R., Ohio) and Susan Collins (R., Maine) to extend a version of the enlarged Affordable Care Act subsidies for at least two years, while cutting off higher-income people from participating and eventually giving enrollees the option of putting money into health savings accounts. It also would eliminate zero-dollar premium plans. But lawmakers from both parties now say the chances of a deal have all but evaporated.
    • “It’s effectively over,” Moreno said Wednesday. Sen. Bill Cassidy (R., La.)—the architect of an adjacent plan—agreed. While Collins declined to be as definitive, she did say that it was “certainly difficult.”
  • Federal News Network tells us,
    • “Following a year of the Trump administration’s overhauls to the civil service, a bicameral group of lawmakers on Wednesday launched a congressional caucus focused on the federal workforce.
    • “Sens. Chris Van Hollen (D-Md.) and Tim Kaine (D-Va.), along with Reps. James Walkinshaw (D-Va.), Steny Hoyer (D-Md.) and Suhas Subramanyam (D-Va.) joined federal unions and good government organizations to announce the newly formed Federal Workforce Caucus. The group aims to more cohesively advocate for federal employees.” * * *
    • “Members of the new Federal Workforce Caucus, which includes at least some bipartisan support, are expected to meet regularly with leaders from federal unions, employee groups and other organizations. The group plans to propose legislation and workforce policies focused on long-term improvements to the career civil service.
    • “The Partnership for Public Service, American Federation of Government Employees, National Federation of Federal Employees and National Active and Retired Federal Employees Association, among several others, are also partners in the new caucus.”
  • OPM Director Scott Kupor has added another post to his Secrets of OPM blog.
  • Per a CMS news release,
    • “CMS continues to bring accountable care to more people with Medicare in 2026, expanding the benefits of high-quality, whole-person health care to achieve better health outcomes for millions of older Americans.
    • “As of January 2026, 14.3 million Medicare beneficiaries are estimated to receive care coordinated by Accountable Care Organizations (ACOs), up from 13.7 million in 2025, representing a 4.4% increase. This includes patients whose health care providers are in Medicare Shared Savings Program (Shared Savings Program) ACOs and entities participating in Center for Medicare and Medicaid Innovation (CMS Innovation Center) accountable care models, as well as other CMS Innovation Center models focused on total cost of care, advanced primary care, and specialty care.
    • “ACOs are groups of doctors, hospitals, and other health care providers who collaborate and provide coordinated, high-quality care to people with Medicare, and they are a critical tool to help Make America Healthy Again by supporting whole person care that addresses prevention, chronic illness and the root causes of disease.
    • “In addition to improving health care, ACOs save billions of dollars for the Medicare program by focusing on delivering the right care at the right time while avoiding unnecessary services and medical errors. ACOs achieve savings because health care providers are held accountable for saving money and improving health care quality, delivering a win for both patients and the Medicare Trust Funds.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
    • “The Food and Drug Administration, which published an early alertabout the devices on Tuesday, said sensor values in Impella RP heart pumps may drift over time.
    • “Erroneous information on automated Impella controllers has caused users to make inaccurate adjustments to the devices and unnecessary pump exchanges, the FDA said.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels. The FDA said patients with impacted sensors should immediately discontinue use and dispose of any affected products. Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7.” 
  • USA Today relates,
    • “A shortage in estrogen patches because of manufacturing issues and some brand discontinuation has been exacerbated by an increase in prescriptions for estrogen since the Food and Drug Administration removed its black-box warning label last fall. The shortage has left women exhausted, frustrated and scrambling each month to call pharmacies for the medicine they need to treat their menopause symptoms.
    • Some women have switched from generic medication to available brand names, which costs them as much as $300 a month and are not covered by insurance. Others have been forced to use a different brand of estrogen each month, leading to inconsistent care. Women have driven 45 miles to pick up a coveted box of the tiny plastic patch they place near their belly button and change twice a week to help with their symptoms, from frozen shoulders to vaginal dryness.”
  • STAT News adds,
    • “Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.
    • “More than two years after its approval, only about 60 patients across the U.S., Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

From the judicial front,

  • Healthcare Dive reports,
    • “The Federal Trade Commission has agreed to what it called a “landmark” settlement with Express Scripts, allowing the company to bow out of the agency’s lawsuit against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “In return, Express Scripts, which is owned by Cigna and is one of the largest PBMs in the country, has agreed to make major changes to its drug benefit designs, including no longer preferring drugs with high list prices on its standard formularies when there are cheaper equivalents and delinking its compensation from the savings it negotiates with drugmakers, the FTC announced Wednesday.
    • “Express Scripts has also agreed to increase transparency, including reporting more data on drug spending and disclosing any kickbacks to brokers that help employers choose PBMs.
    • “Notably, the company also agreed to reshore its group purchasing organization Ascent from Switzerland back to the U.S.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The measles outbreak in South Carolina has increased to 876 cases, the state’s Department of Public Health reported Feb. 3. Last week, the South Carolina outbreak surpassed last year’s outbreak in Texas, which had 762 cases. The agency said the number of public exposure sites indicates community spread is occurring, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. “Vaccination continues to be the best way to prevent measles and stop this outbreak,” the department said.” 
  • MedPage Today informs us,
    • “In this self-controlled case series, myocardial infarction rates were nearly 9 times greater in the week after an RSV-related hospitalization compared with a control period prior to infection.
    • “Stroke rates were more than 7 times higher compared with the control period.
    • “Recent research has suggested that RSV vaccination lowers the risk of cardiorespiratory hospitalizations.”
  • and
    • The effectiveness of last season’s COVID vaccines among immunocompetent adults reached 40% against hospitalization and 79% against invasive mechanical ventilation or death.
    • Those levels of protection were similar among seniors and sustained through 6 months post-vaccination.
    • This study is a reminder that “vaccines still have a role, even in the current epidemiological landscape,” an expert said.
  • Per an NIH news release,
    • The National Institutes of Health (NIH) has opened the East Palestine Train Derailment Health Research Program Office to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio. The new office is the hub of a five-year, $10 million research initiative funded by NIH.
    • “Federal research experts will engage directly with the community, coordinate studies, and help enroll residents in federally supported health research through the new office.” * * *
    • Three years ago, on Feb. 3, 2023, a Norfolk Southern freight train derailment involving 38 railcars carrying hazardous chemicals — including vinyl chloride, butyl acrylate, ethylene glycol and benzene residue — resulted in prolonged fires and controlled burns in East Palestine. Several railcars burned for more than two days, and emergency responders conducted controlled burns that raised concerns about the potential airborne release of hydrogen chloride and phosgene.
    • “Local residents reported a range of initial health symptoms, including headaches and respiratory, skin and eye irritation. These reports prompted concerns about potential longer-term effects on maternal and child health, as well as psychological, immunological, respiratory and cardiovascular health.”
    • “This research program is designed to bring rigorous, independent science directly to the community,” said NIH Director Jay Bhattacharya. “By establishing a local presence, we can better engage residents, support enrollment in studies, and ensure the research reflects the real experiences and concerns of the people affected.”
  • Genetic Engineering and BioTechnology News observes,
    • “As drug‑resistant hospital infections continue to rise worldwide, a team of Australian researchers has identified a surprising new bacterial vulnerability: a sugar that only microbes make. By designing antibodies that recognize this sugar, the scientists were able to clear lethal infections in mice—offering a potential new strategy for tackling multidrug‑resistant pathogens.
    • “The work, published in Nature Chemical Biology, describes the development of monoclonal antibodies that target pseudaminic acid, a carbohydrate found on the surface of many dangerous bacteria but absent from human cells. The study, titled “Uncovering bacterial pseudaminylation with pan‑specific antibody tools,” demonstrates that this sugar may serve as a highly selective molecular flag for immunotherapy.”
  • Per Healio,
    • “Once-weekly subcutaneous tirzepatide may not raise risk for depression compared with placebo, according to a post hoc analysis of the SURMOUNT trials.
    • “As Healio previously reported, in January the FDA requested that risk for suicidal ideation and behaviors be removed from labels for liraglutide (Saxenda, Novo Nordisk), injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk) and tirzepatide (Zepbound, Eli Lilly). 
    • “In data published in Obesity, researchers found adults receiving tirzepatide in three SURMOUNT trials did not experience worsening of depression throughout the studies.
    • “The low occurrence of these events with tirzepatide is similar to that observed in pooled analyses of semaglutide 2.4 mg and liraglutide 3 mg, both GLP-1 receptor agonists approved for weight management,” Thomas A. Wadden, PhD, professor of psychology in psychiatry at Perelman School of Medicine, University of Pennsylvania in Philadelphia, told Healio. “The present report provides the first detailed analysis of the risk of these psychiatric events with tirzepatide.”

From the U.S. healthcare business and artificial intelligence front,

  • BioPharma Dive reports,
    • “Eli Lilly shares jumped early Wednesday after the company reported better-than-expected fourth-quarter revenue and shared higher forecasts for 2026, buoyed by its obesity and diabetes medicines.
    • “Fourth-quarter revenue soared 43% to $19.3 billion, Lilly said Wednesday. That’s 7% above the Wall Street consensus, Leerink Partners analyst David Risinger wrote in a note to clients. Earnings per share beat estimates by 9% and operating income came in 13% higher than analysts expected, he said.
    • “This year, Lilly expects revenue of between $80 billion and $83 billion, with non-GAAP earnings of $33.50 to $35 a share. Analysts had been expecting midpoint forecasts of $78.5 billion for revenue and $33.30 for EPS, according to Risinger.”
  • Fierce Pharma tells us,
    • “Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.
    • “The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.”
  • MedTech Dive informs us,
    • “Boston Scientific has been one of the big winners of the pulsed field ablation revolution. Over the past two years, the company has reported strong electrophysiology sales growth — sometimes in the triple digits — and declared itself the clear market leader in PFA.
    • “However, on a Wednesday morning earnings call, analysts questioned executives on the electrophysiology unit’s potential after U.S. sales growth stalled in the fourth quarter compared with the third quarter.
    • “CEO Mike Mahoney told investors that the company remains confident in PFA’s potential, even as the market becomes more penetrated and competition in the space ramps up. Mahoney said that the electrophysiology market should grow about 15% in 2026, and the company expects to grow above that rate.
  • Beckers Clinical Leadership notes,
    • [Nurse] workforce projections from HHS’ Health Resources and Services Administration indicate “the gap between the demand for and supply of RN services is expected to shrink over the next decade from 10% in 2027 to 6% in 2037,” according to a January report from the council. 
    • “This forecast is partly due to an increase in first-time examinees of the National Council Licensure Examination, according to the report. 
    • “By comparison, the U.S. supply of licensed practical nurses and licensed vocational nurses is projected to decrease a whopping 36% by 2037, HRSA data shows. These workforces have declined in labor participation and absolute licensure statistics across most states, the report said. 
    • “Although the projected outlook for the RN workforce is more favorable than it is for LPNs/LVNs, maldistribution of providers remains a critical issue, with nonmetropolitan areas projected to face significantly higher shortages than metropolitan areas in the coming years,” the report said. “These issues exacerbate the broader projected shortfall owing to the dual trends of increasing demand due to an aging population and an aging workforce.”
  • Cardiovascular Business lets us know,
    • “Early adopters have been using robotics to perform cardiac surgeries in the United States for years now, but multiple factors—including high costs and early concerns about patient outcomes—have held back widespread implementation.   
    • “According to a new commentary in The Annals of Thoracic Surgery, however, robotic cardiac surgery has gained considerable momentum in the last year. Is now the time for this trend to truly take off?
    • “A convergence of improved training frameworks, maturing technology and increasingly standardized quality processes have supported a broader and more sustainable growth,” wrote co-authors Andrea Amabile, MD, a cardiothoracic surgery resident with the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute, and Johannes Bonatti, MD, director of the cardiac robotic surgery at the UPMC Heart and Vascular Institute. “In this context, the past year has brought forward a set of notable global milestones that collectively illustrate the evolving capabilities of robotic cardiac surgery.”
  • Per Beckers Health IT,
    • “KLAS Research released its annual “Best in KLAS” report Feb. 4, ranking healthcare technology vendors and service providers across more than 140 market segments based on feedback from the clinicians and administrators who use them.
    • “The report, now in its 28th year, draws on tens of thousands of provider evaluations to identify the top-performing solutions in categories spanning electronic health records, revenue cycle, cybersecurity, AI and other areas. This year’s edition arrives as AI — particularly ambient speech technology — continues to reshape clinical workflows, and as health systems navigate tightening finances alongside growing vendor competition.
    • “For the 16th consecutive year, Epic was named the top Overall Health System Suite. Epic also won Best in KLAS recognition in 11 market segments.
    • [The article lists] the winners in some of the report’s most closely watched categories. The full report is accessible from KLAS Research here.
  • Per Beckers Payer Issues,
    • “Optum has launched a pair of AI-driven prior authorization products, one designed to speed up submissions on the provider side and another to accelerate clinical reviews for payers.
    • “The provider-facing product, Digital Auth Complete, went live in January in collaboration with digital health company Humata Health. The payer-facing product, InterQual Auth Accelerator, began piloting with two large health plans in late 2025, with the first payer expected to be fully live by April.
    • “It’s a combination of three things,” John Kontor, MD, senior vice president of clinical technology at Optum Insight, told Becker’s, explaining why the products are coming to market now. “It is the policy changes, including CMS-0057, that have accelerated everyone’s urgency to get this figured out. Two, it’s the readiness now of technology to be able to support solving many of these administrative, burdensome problems in healthcare. And third, the policy changes really reflect both industry frustration and impatience and the public’s real desire to get real and better answers to the problems of prior authorization.”
  • Per Fierce Healthcare,
    • “Epic is rapidly building out artificial intelligence tools integrated into its electronic health record solution as health IT companies strive to keep up with the dizzying speed of AI innovation.
    • “This week, the EHR giant released AI Charting, a built-in feature that ambiently listens during patient visits and drafts the clinician’s note. The AI charting feature also queues up orders based on the conversation. 
    • “Epic CEO Judy Faulkner announced the AI Charting technology during the company’s Users Group Meeting (UGM) in August as part of its collaboration with longtime partner Microsoft.
    • “AI models are advancing at a rapid pace; we continue to work with Microsoft on AI Charting and use a variety of different models through the Microsoft Azure platform,” an Epic spokesperson said Wednesday.”

Tuesday report

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NCQA, Patient safety, SCOTUS, Uncategorized–

From Washington, DC,

  • Federal News Network reports,
    • “The House [of Representatives] passed a spending package to end a short-term partial government shutdown and fund most federal agencies through the end of the fiscal year.
    • “The spending deal, which includes a two-week continuing resolution for the Department of Homeland Security, was passed by the Senate last Friday.
    • “President Donald Trump signed the spending package into law on Tuesday afternoon.” * * *
    • “The spending package includes language guaranteeing back pay to federal employees who were briefly furloughed during the partial shutdown.” * * *
    • “After Trump signed the spending plan into law, OPM directed furloughed employees to return to work.”
  • The Wall Street Journal notes,
    • Twenty-one Republicans voted against the package [on the final vote [217-214] for passage], largely hard-liners who wanted to use the spending package as a vehicle to tighten election procedures. Twenty-one Democrats—mostly a collection of appropriations-committee members and centrists—voted for it.
  • Fierce Healthcare adds,
    • “The legislation finalizes several key healthcare extenders including provisions of the Medicare telehealth program and Acute Hospital Care at Home waiver as well as major supplementary funding programs for rural hospitals and those with high proportions of government-covered patients. The bill provides a five-year extension of the Acute Hospital Care at Home program and a two-year extension for Medicare telehealth flexibilities. The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
    • “The bill also introduces reforms to pharmacy benefit manager (PBM) practices, including elements that would prevent PBMs from tying compensation in Part D to the list price of drugs, and boost price transparency for employers in their PBM contracts.
    • “Other provisions in the bill require that Medicare Advantage plans provide accurate provider lists, addressing so-called “ghost networks” that have come under fire in recent years. It would also require that health systems establish unique identification numbers for outpatient services, allowing the Centers for Medicare & Medicaid Services to track pricing in these facilities.”
  • Rep. Jodey Arrington (R TX), the chairman of the House Budget Committes, writing in Real Clear Health, shares his vision of a second reconciliation bill that would focus on healthcare.
  • The HHS Office of Inspector General posted “Medicare Advantage Industry Segment-Specific Compliance Program Guidance.”
  • Per an AHIP news release,
    • “Public and private payers are delivering greater value to Americans and the health care system by advancing value-based care (VBC). AHIP, in collaboration with the Centers for Medicare & Medicaid Services (CMS), today released the results of the 2025 Alternative Payment Model (APM) Adoption Survey. The findings reaffirm the commitment of the federal government and private health plans to advance VBC and APM models that shift away from fee-for-service (FFS) models toward payment arrangements that reward quality, efficiency and improved patient outcomes.
    • “This year’s survey highlights how health plans continue to work hand-in-hand with providers to advance value-based care and drive meaningful improvement for patients. These innovative payment models reward outcomes, resulting in patient-centered, high-quality, coordinated care that is more affordable for Americans,” said Danielle Lloyd, MPH, AHIP’s senior vice president of private market innovations and quality initiatives for Clinical Affairs.” * * *
    • To view the full 2025 survey findings, click here.
  • NCQA announced today,
    • “Every year, NCQA seeks public comment about proposed changes to HEDIS Volume 2.
    • “Public comment is your opportunity to weigh in on the relevance, scientific soundness and feasibility of new and revised measures for HEDIS. Your feedback helps us determine changes to our programs, procedures and processes.
    • “This year’s public comment is open February 13–March 13.
    • We’d like input on:
      • Seven new HEDIS measures.
      • Revising three HEDIS measures.
    • “This year’s public comment will go live Friday, February 13, at 9:00a.m. ET.
    • “We’ll post the link and more details here, so check back on February 13.”
  • The Washington Post relates,
    • “The American Society of Plastic Surgeons has issued a broad recommendation against gender transition surgeries for youths, becoming the first major medical association in the United States to narrow its guidance on pediatric gender care amid a crackdown by the Trump administration.
    • “A statement sent Tuesday to the group’s 11,000 members and obtained by The Washington Post recommends surgeons delay gender-related chest, genital and facial surgery until a patient is at least 19 years old. Fewer than 1,000 minors in the United States receive such surgeries every year, according to research published in JAMA, the American Medical Association’s journal, and the vast majority of the procedures are mastectomies, not genital surgeries.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices could display inaccurate information due to a malfunction of the differential pressure sensors. The company reported 22 injuries associated with the issue since Jan. 15.” 
  • MedTech Dive relates,
    • “Abbott received a warning letter from the Food and Drug Administration related to its FreeStyle Libre continuous glucose monitors.
    • “The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA.
    • “The warning letter does not affect Abbott’s ability to manufacture, market or distribute Libre products, wrote Leerink Partners analyst Mike Kratky and J.P. Morgan analyst Robbie Marcus.”
  • The Wall Street Journal informs us,
    • “AstraZeneca AZN said the U.S. Food and Drug Administration rejected an initial submission for its Saphnelo lupus drug in injection form, and vowed to work with the regulator to move forward with an updated application.
    • “The U.K. pharmaceutical company said Tuesday that the FDA issued a complete response letter, which indicates that a new drug application can’t be approved in its present form, regarding Saphnelo for subcutaneous administration. The company said it subsequently provided information requested in the letter and that it was committed to working with the FDA to progress the application as quickly as possible.
    • “A decision on the updated application is expected in the first half of 2026, AstraZeneca said.
    • “The drug, a treatment for the autoimmune disease systemic lupus erythematosus, is already approved as an intravenous infusion and that form of administration remains commercially available, AstraZeneca said.”
  • Fierce Biotech tells us,
    • “As the first CAR-T treatment for an autoimmune disease draws ever closer, officials at the FDA have signaled a willingness to support the development of these novel cell therapies with a flexible regulatory approach.
    • “While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the FDA is equally wary of their “unpredictable long-term toxicity,” according to an article published Monday in the Annals of Internal Medicine.
    • “In the article, Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research, and two other regulators said that, recognizing the complexity of autoimmune conditions in terms of seriousness and type, the agency will work with CAR-T makers “on a case-by-case basis to encourage appropriate study populations in rheumatologic autoimmune disease.”
    • “Simultaneously, citing a need to monitor a drug’s effect on fertility, the FDA officials recommended that industry conduct long-term follow-up studies for CAR-T products in the autoimmune setting, “as is standard for genetic therapies and CAR T-cells for oncologic indications.”
    • “While the FDA “shares enthusiasm for this class of products,” it will “carefully shepherd” the advancement of clinical studies “focused on the development, durability, and long-term safety of CAR T-cell therapies,” the regulators wrote.”
  • STAT News lets us know, “AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? Doctronic claims its AI doctor doesn’t need FDA approval. Experts aren’t so sure.”

From the public health and medical / Rx research front,

  • Nature reports,
    • “Nearly 40% of new cancer cases worldwide are potentially preventable, according to one of the first investigations1 of its kind, which analysed dozens of cancer types in almost 200 countries.
    • “The study found that in 2022, roughly seven million cancer diagnoses were linked to modifiable risk factors — those that can be changed, controlled or managed to reduce the likelihood of developing the disease. Overall, tobacco smoking was the leading contributor to worldwide cancer cases, followed by infections and drinking alcohol. The findings suggest that avoiding such risk factors is “one of the most powerful ways that we can potentially reduce the future cancer burden”, says study co-author Hanna Fink, a cancer epidemiologist at the World Health Organization’s International Agency for Research on Cancer in Lyon, France.
    • “The study was published today in Nature Medicine.”
  • The American Journal of Managed Care relates,
    • “The majority (57.5%) of commercially insured patients had at least 1 chronic condition in 2024. The average allowed amount1 for a patient with no chronic conditions was $1590, whereas the average allowed amount for a patient with 1 chronic condition was nearly double ($3039). Of 44 common chronic conditions studied, hyperlipidemia, or high cholesterol, was the most common, with a crude prevalence2 of 21.2%. These and other findings are reported in a new FAIR Health white paper: Chronic Conditions in the United States: A Study of Commercial Claims.” * * *
    • “Many patients had more than 1 chronic condition. For example, 11.5% of patients had 2 conditions, and 9.1% had 3.
    • “Some chronic conditions frequently co-occur. In the commercially insured population, 33.4% of patients had hyperlipidemia, hypertension, obesity, or some combination of these, and 4.3% had all 3.3 Half the patients with any one of these conditions had more than 1.” * * *
    • “For the complete white paper, click here“
  • CNN tells us,
    • “Men develop a greater risk of cardiovascular disease years earlier than women — starting at around age 35, according to a new long-term study.
    • “The report, published Wednesday in the Journal of the American Heart Association, followed more than 5,000 adults from young adulthood and found that men reached clinically significant levels of cardiovascular disease about seven years earlier than women.
    • “Experts advise both men and women to monitor their heart health in early adulthood and to see their doctor regularly.
    • “Heart disease doesn’t happen overnight; it develops over years. One of the things I think oftentimes people aren’t aware of is that it can start really early in your 30s or 40s,” said study coauthor Dr. Sadiya Khan, professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine in Chicago.
    • “Even if you don’t have heart disease at that time, your risk can start at that time.”
  • MedPage Today adds,
    • “National data showed 79% of adults with hypertension didn’t have their blood pressure within the blood pressure goal recommended by guidelines.
    • “Most of those uncontrolled hypertension cases went untreated by blood pressure medication.
    • “These findings highlight a large gap in hypertension control that treating hypertension earlier and more intensively could address.”
  • The New York Times observes,
    • “For much of the 20th century and beyond, social scientists attributed a range of chronic mental health problems to dysfunction between infants and their mothers, who were categorized as overbearing, rejecting, domineering or ambivalent.
    • “But a team of researchers from Pennsylvania State University has found that at times the early parenting behavior of fathers may have a greater impact on children’s health.
    • “For a study published recently in the journal Health Psychology, the scientists observed three-way interactions between 10-month-old infants, their fathers and their mothers, and then checked in on the families when the children were 2 and 7.
    • “They found that fathers who were less attentive to their 10-month-olds were likely to have trouble co-parenting, instead withdrawing or competing with mothers for the children’s attention. And at age 7, the children of those fathers were more likely to have markers of poor heart or metabolic health, such as inflammation and high blood sugar.
    • “Mothers’ behavior did not have the same effect, said Alp Aytuglu, a postdoctoral scholar at Penn State’s College of Health and Human Development and an author of the paper.
    • “We of course expected that family dynamics, everybody in the family, fathers and mothers, would impact child development — but it was only fathers, in this case,” Dr. Aytuglu said.”
  • Per Health Day,
    • “More than one-quarter of young children experience persisting symptoms after concussion (PSaC), according to a study published online Jan. 26 in Pediatrics.
    • “Sean C. Rose, M.D., from The Ohio State University in Columbus, and colleagues assessed the frequency of PSaC after early childhood concussion and identified potential predictors of PSaC. The analysis included 235 young children (ages 6 months to <6 years) with concussion, 108 with orthopedic injury, and 75 community controls.
    • “The researchers found that at one month postinjury, PSaC were documented in 28 percent of children with concussion, higher than in the orthopedic injury group (10 percent) and the community control group (2 percent). PSaC were documented in just under one-quarter of children at three months postconcussion (24 percent) and 16 percent at 12 months. PSaC at one month postconcussion was predicted by total symptom burden in the emergency department (odds ratio, 1.108). There were no associations for age, loss of consciousness, receiving brain imaging in the emergency department, attending daycare or school, or parent education with PSaC.”
  • and
    • “The symptoms women experience on the verge of menopause could be vastly different from what they might expect, a new study says.
    • “Women in perimenopause – the time leading up to their final period, as well as the year after – expect to be plagued with hot flashes and night sweats.
    • “However, these women reported symptoms like exhaustion and fatigue far more frequently than those typically associated with menopause, researchers reported Jan. 28 in the journal Menopause.
    • “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives,” lead researcher Dr. Mary Hedges said in a news release. She’s a community internal medicine physician at the Mayo Clinic in Jacksonville, Florida.”
  • Per BioPharma Dive,
    • “An experimental obesity shot Pfizer got through a buyout of Metsera helped enrollees in a mid-stage trial lose significantly more weight than a placebo, spurring up to an 11% reduction over 28 weeks using a regimen that switched from a weekly to monthly dose after 12 weeks.
    • “When including only participants who completed the trial, the shot helped people lose up to 12 percentage points more of their body weight than those who received a placebo. Though cross-trial comparisons can be misleading, the results “look slightly inferior” to what was seen in testing of Eli Lilly’s blockbuster Zepbound at a similar timepoint, wrote Leerink Partners analyst David Risinger.
    • “Pfizer executives noted on a conference call that, going forward, they intend to test a far higher dose than they did in Phase 2 testing. Phase 3 trials starting later this year will involve a dose that’s double the highest one used in the Phase 2.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente and Renown Health have wrapped the paperwork on a deal forming an insurance and outpatient care joint venture in northern Nevada. 
    • “The arrangement announced last September (see below) represents an entry into the geographic market for Kaiser, the country’s largest nonprofit health system. It brings Hometown Health—an existing health plan run by Renown Health, a Reno-based, two-hospital nonprofit system—plus an existing primary care medical office under joint ownership. The partners have plans to open two more facilities in 2026, plus retail pharmacies in 2027. 
    • “This joint venture with Renown Health allows us to extend our value-based care model and nation-leading health outcomes to northern Nevada, in collaboration with Renown Health’s trusted local teams,” Greg Adams, chair and CEO of Kaiser, said in a Tuesday announcement. “Together, we will improve health outcomes; expand access to affordable, high-quality care; and serve the needs of this growing community.”
    • “Financial terms of the transaction were not disclosed.” 
  • and
    • “Primary care company Carbon Health filed for Chapter 11 bankruptcy relief in Texas. 
    • “The company, which offers both in-person care at nearly 100 clinics and virtual care services, said Monday it reached a restructuring agreement with its existing lenders that establishes a “clear path to recapitalization and new ownership.”
    • “Carbon Health intends to pursue a dual-track, court-supervised process that allows it to enter a Chapter 11 plan premised on a debt-for-equity exchange, and a post-petition marketing and sale process for all or a portion of its assets, the company said in a press release issued Monday.
    • “This structure is intended to maximize value while preserving flexibility as the process moves forward,” Carbon Health executives said.
    • “To implement the restructuring, Carbon Health and certain affiliates have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas.”
  • Healthcare Dive relates,
    • “Humana is launching an artificial intelligence tool that aims to help its call center workers answer beneficiaries’ questions about their coverage, the insurer said Tuesday. 
    • “Agent Assist, developed in partnership with Google Cloud, can summarize conversations between workers and enrollees in real time while highlighting relevant information, like the member’s benefit and eligibility details and important context from the call, Chris Sakalosky, vice president of strategic industries at Google Cloud, said via email.
    • “The insurer began rolling out Agent Assist in October, and plans to implement the tool across Humana’s service centers this year.”
  • Per MedCity News,
    • “About 50 million people in the U.S. are affected by autoimmune disease, and about 80% of them are women. When women give birth, they often experience significant hormonal changes that can trigger new diagnoses or symptoms of autoimmune disease.
    • “That’s why WellTheory, a platform focused on autoimmune disease, launched a new program last week aimed at supporting women in the postpartum period.
    • ‘Atherton, California-based WellTheory treats autoimmune conditions such as Addison’s disease, celiac disease, multiple sclerosis and lupus. Using a collaborative care model, it partners with patients’ physicians to deliver personalized plans focused on nutrition, stress, sleep and movement. The company offers video sessions, unlimited expert messaging and diagnostics. It serves both employers and health plans.
    • “The new postpartum program includes personalized care plans and one-on-one support with autoimmune and hormonal health experts. WellTheory also provides advanced hormonal testing if appropriate, including assessment of sex hormones, cortisol levels and metabolites. This helps identify root causes of conditions like postpartum depression.”
  • Adam Fein writing in his Drug Channels blog lets us know,
    • “The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which track all U.S. spending on healthcare. (Links below.)
    • “We spent an astounding $5,278,588,000,000 on healthcare in 2024. Yes, that’s $5.3 trillion!
    • “Retail outpatient prescription drugs accounted for less than 9% of that total. More than half of net outpatient drug spending was paid by federal, state, and local government programs. Below, we delve into the spending trends, which reveal the impact of the Inflation Reduction Act (IRA) on Medicare spending, the boom in healthcare marketplaces, and the post-pandemic bust in Medicaid. 
    • “Contrary to what you might read, the government’s data show that drug spending growth was not driven by purportedly “skyrocketing” drug prices. In reality, nearly all of the increase in drug spending reflected higher utilization—more people treated, more prescriptions dispensed, and shifts among drugs dispensed—rather than higher net prices.”
  • Per Fierce Pharma,
    • “Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its post-Keytruda future with what it foresees as a host of major sales opportunities over the next decade.
    • “Thanks in part to its recent acquisitions of Verona Pharma and Cidara Therapeutics, the company sees new growth drivers delivering potential annual revenue of more than $70 billion by the “mid-2030s,” Merck said in its fourth-quarter and full-year earnings presentation (PDF).
    • “To put the $70 billion number into context, Davis pointed to the figure as being more than double the $35 billion Keytruda is expected to pick up during its peak sales year in 2028. The oncology superstar is slated for a loss of exclusivity (LOE) in 2028, and a growing pipeline of Keytruda biosimilars is already lining up to take a shot at the drug’s massive market.
    • “Our belief in our ability to have substantial growth once we get closer to the LOE is as high as it’s ever been,” Davis emphasized on a conference call. “And we’re not done.”
  • and
    • “During the first six months of Maziar Mike Doustdar’s tenure as Novo Nordisk’s CEO, the company enjoyed a run of positive momentum highlighted by the launch of its Wegovy pill and a recent stock-price runup. But investor optimism came to a sudden halt Tuesday as the company warned of significant sales and earnings declines in 2026.
    • “Tuesday, Novo put out word that it’s expecting sales and earnings to slide between 5% and 13% this year. In 2025, Novo generated sales growth of 10% and operating profit growth of 6%, the company said.
    • “A few factors are playing into the 2026 guidance. For one, the company said it’s expecting sales to decline in the U.S. amid “intensifying competition” and lower prices in some areas of its business. Novo is also warning of a sales hit from the recent “Most Favored Nation” pricing deal it struck with the Trump administration.
    • “The company is also forecasting a currency hit as the U.S. dollar has lost value against the Danish krone, Novo’s local currency.”
  • Per MedTech Dive,
    • “Medtronic plans to acquire CathWorks, which makes tools to help detect coronary artery disease, the companies announced on Tuesday. Medtronic will pay up to $585 million, with the potential for undisclosed earn-out payments after the acquisition closes.
    • “The companies have worked together since 2022, when Medtronic agreed to co-promote CathWorks’ FFRangio System in the U.S., Europe and Japan.
    • “The FFRangio System uses artificial intelligence and computational science to provide an assessment of the entire coronary tree using routine angiograms, a type of X-ray for imaging blood vessels. The system can provide fractional flow reserve, or FFR, values that help detect what lesions are causing a reduction in blood flow. The system can also help physicians measure the dimensions of a lesion during an operation.”
  • Per Radiology Business,
    • “RadNet Inc. is entering the Midwest by acquiring a 60-year-old private practice’s outpatient imaging assets. 
    • “The Los Angeles company has reached a deal to acquire six freestanding centers, all operated by Indianapolis-based Northwest Radiology, for an undisclosed sum. 
    • “Founded in 1967, NWR is one of Indiana’s largest independent imaging groups, employing 18 physicians. They will continue to provide contracted services across the practice’s former locations. 
    • “The centers are primarily located in Carmel, a growing northern suburb of Indianapolis recently recognized by Travel & Leisure magazine for its livability. RadNet—which, as a publicly traded company, will eventually disclose the purchase price in a future regulatory filing—expects to net $18 million in annual revenue from the sale. 
    • “Steve Forthuber, president and CEO of Eastern Operations for RadNet, said the practice has built “remarkable trust and confidence” among the local physician community. The company plans to work closely with NWR radiologists to further expand their “clinical reach and capabilities.” 

Monday report

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump demanded Monday that House lawmakers back the bipartisan spending deal passed by the Senate last week and set aside policy demands in an effort to quickly end a partial government shutdown. 
    • “We need to get the Government open, and I hope all Republicans and Democrats will join me in supporting this Bill, and send it to my desk WITHOUT DELAY,” Trump posted on Truth Social. “There can be NO CHANGES at this time.”
    • “House Speaker Mike Johnson (R., La.) is trying to pass as soon as Tuesday the $1.2 trillion package that funds large parts of the federal government through the end of the fiscal year while funding the Department of Homeland Security for just two weeks. That short-term extension is designed to provide time for a bipartisan deal to be reached on stricter policies for immigration-enforcement agents.” 
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services today announced a new behavioral health initiativeto assist homeless individuals with substance use treatment and recovery. The program, called the Safety Through Recovery, Engagement, and Evidence-based Treatment and Supports, or STREETS, will focus on psychiatric care, medical stabilization and crisis intervention, HHS said. The initiative is tied to an executive order issued by the administration last week on substance use.” 
  • In January 2024 OPM proposed to create to advance the FEHB / PSHB eligibility date to the first day of employment.  AFHO, the trade association that the FEHBlog represents, used the public comment period to advocate for the HIPAA 820.  Today, in a welcome deregulatory step, OPM withdrew the proposed rule.
  • MedCity News considers whether “It is Time to Change the Independent Dispute Resolution Process of the No Surprises Act.” The FEHBlog thinks so because the current process is opaque.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said Thursday.
    • “The premarket approval filing for Grail’s Galleri test focuses on a U.S. study of more than 25,000 people and a randomized, controlled trial the company is running in the United Kingdom.
    • “Grail President Josh Ofman said at an event in January that approval will be a “major trigger” for evidence-based decisions with U.S. payers and could enable Medicare coverage.”
  • Cardiovascular Business relates,
    • “eMurmur, an Ontario-based artificial intelligence (AI) startup, has received U.S. Food and Drug Administration (FDA)clearance for its suite of algorithms designed to evaluate heart recordings captured by digital stethoscopes. 
    • “The newly approved offering, eMurmur Heart AI, was designed to detect both the presence and absence of heart murmurs. In addition, it can provide hemodynamic data that helps care teams as they develop patient management strategies. eMurmur Heart AI can be accessed through the company’s own standalone software—available as a web platform or mobile app—or through a third-party system.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The Centers for Disease Control and Prevention released its annual progress report on health care-associated infections Jan. 29, which found continued decreases in hospitalizations from multiple infections last year. Among the findings, there was an 11% decrease in hospital-onset Clostridioides difficile, or C. difficile, infection; a 10% decrease in catheter-associated urinary tract infections, or CAUTI; a 9% decrease in central line-associated bloodstream infections, or CLABSI; and a 7% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA. 
    • “Among inpatient rehabilitation facilities, there was an 18% decrease in hospital-onset C. difficile infections and an 8% decrease in CAUTI. For long-term care hospitals, there was a 23% decrease in ventilator-associated events and a 15% decrease in hospital-onset C. difficile. The report recommended providers continue reinforcing prevention practices, review HAI surveillance data to identify areas for improvement and address any gaps in prevention practices.”
  • Cardiovasular Business relates,
    • “Researchers have developed a new injectable therapy that could help protect a patient’s brain after they experience a stroke. The team behind this new treatment shared a look at its early progress in Neurotherapeutics.
    • “The therapy in question was built to cross the blood-brain barrier and help repair brain tissue, limiting the risk of permanent brain damage and encouraging a healthy recovery following an ischemic stroke. Co-author Samuel Stupp, PhD, founding director of Northwestern University’s Center for Regenerative Nanomedicine, previously found that supramolecular therapeutic peptides (STPs) technology could reverse paralysis and repair tissue in mice after a single injection. This analysis took those observations related to the potential benefits of STPs and transferred them to a new area of medicine. 
    • “Current clinical approaches are entirely focused on blood flow restoration,” co-author Ayush Batra, MD, an associate professor with the Northwestern University Feinberg School of Medicine and co-director of the NeuroVascular Inflammation Laboratory at Northwestern, said in a statement. “Any treatment that facilitates neuronal recovery and minimizes injury would be very powerful, but that holy grail doesn’t yet exist. This study is promising because it’s leading us down a pathway to develop these technologies and therapeutics for this unmet need.”
  • MedPage Today informs us,
    • “Use of single maintenance and reliever therapy (SMART) for moderate-to-severe asthma saved money by improving outcomes, according to a meta-analysis.
    • “While SMART is recommended by guidelines, combination inhalers aren’t FDA approved for both rescue and maintenance therapy, and thus insurance coverage has been a struggle in the U.S.
    • “Finding an economic advantage should influence payer decisions, the researchers suggested, calling for broader formulary inclusion of SMART.”
  • and
    • “All hypertensive disorders of pregnancy were tied to increased long-term cardiovascular risk, but superimposed preeclampsia carried the highest risk.
    • “All subtypes were significantly associated with higher risks of heart failure and stroke, and most were associated with higher risk of cardiovascular death.
    • “Unspecified hypertension was associated with myocardial infarction, while chronic and unspecified hypertension were both associated with atrial fibrillation.”
  • The Endocrinology Advisor lets us know that “the fit-fat index (FFI), which calculates the ratio of cardiorespiratory fitness to various adiposity measures (BMI, WHR, or WHtR), is significantly associated with lower risks for cardiovascular and all-cause mortality.”
  • Genetic Engineering and BioTechnology News points out,
    • “Evidence has been rising over the past few years that the gut microbiome can significantly influence how well cancer treatments work, especially immunotherapies. But the underlying mechanism has remained unclear. Now, a new study reveals how bacteria in the gut can help determine whether the amino acid asparagine (obtained from diet) will increase tumor growth or activate immune cells against the cancer​.
    • “The findings, published in Cell Microbe and Host in the paper, “Microbiota utilization of intestinal amino acids modulates cancer progression and anticancer immunity,” could lead to a novel cancer treatment approach and monitoring strategy; instead of targeting tumors directly, clinicians may one day be able to reshape the gut microbiome or diet to starve tumors while supercharging immune cells.
    • “Our study suggests that we need to think about how the interplay of diet, gut microbiota and tumor-infiltrating immune cells could affect cancer growth and response to therapy. We can’t overlook this key level regulation,” said Chunjun Guo, PhD, associate professor of immunology at Weill Cornell.”
  • Per BioPharma Dive,
    • “Novo Nordisk’s experimental combination shot CagriSema helped people with diabetes and obesity lower their blood sugar and lose more weight than the blockbuster drug Wegovy in a Phase 3 trial, the company said Monday, building the case for regulatory approval.
    • “The results come from one of several studies Novo has underway in obesity and diabetes for CagriSema, which adds a second metabolic drug to the active ingredient from Wegovy in a fixed-dose injection. The Denmark-based drugmaker has already asked the Food and Drug Administration to approve the shot in obesity.
    • “The data could sharpen Novo’s rivalry with Eli Lilly and its obesity drug Zepbound, which has overtaken Wegovy to become the biggest-selling obesity treatment in the world. Looking at all participants enrolled in the trial, CagriSema’s weight loss and blood-sugar reductions fall numerically short of Zepbound’s, but a head-to-head trial comparing the two hasn’t been completed yet.”
  • and
    • “An experimental rare disease drug from Sanofi succeeded against one so-called lysosomal storage disorder but failed against another, the French pharmaceutical company said Monday.
    • “According to Sanofi, the drug, dubbed venglustat, missed its primary objective in a Phase 3 study testing it against Fabry disease. However, in another study in a form of Gaucher disease, the drug met its main goal and three out of four key secondary endpoints. Sanofi didn’t provide details — they’ll be shared at medical meeting this week — but said it intends to submit the Gaucher results to global regulatory authorities.”

From the U.S. healthcare business and artificial intelligence front,

  • MedCity News reports,
    • “Access to primary care is collapsing in the U.S., creating an opening for new models that lower costs and improve outcomes.
    • “This week, Premise Health and Crossover Health moved to capitalize on that opportunity, announcing an agreement to merge into a single company focused on scaling primary care access. The combined organization will provide onsite, nearsite and virtual care for more than 400 employers with millions of members, operating nearly 900 wellness centers across the country.
    • “The new entity will be led by Premise CEO Stu Clark. He framed the deal as a convergence of two companies with the same thesis: advanced primary care is the lever to disrupt U.S. healthcare. Both companies define advanced primary care as an integrated bundle of primary care, behavioral health, pharmacy services and care navigation.
    • “Crossover and Premise have proven that a few things happen when you deploy our advanced primary care models: access goes up, health improves and costs go down. Costs go down for the employer as well as for the family,” Clark stated.
    • “The company’s target customers will be large self-insured employers, mainly Fortune 1000 companies, unions, Native tribes and government entities, he said.”
  • Healthcare Dive relates,
    • “Tenet has regained full ownership of Conifer Health Solutions, acquiring the remaining stake in its revenue cycle management business from CommonSpirit Health.
    • “CommonSpirit will pay Tenet almost $1.9 billion over the next three years to get out of its existing services contract, according to the deal announced Monday. That’s offset by $540 million that Conifer will pay CommonSpirit for its almost 24% equity stake and to eliminate CommonSpirit’s capital account.
    • “All told, Tenet executives said the deal creates almost $2.7 billion in total value to the system through the cash payments, the reduction of liability on its balance sheet and the value of the additional Conifer equity. Tenet’s stock rose 2% in morning trade Monday following the news.”
  • Fierce Healthcare informs us,
    • “Community Health Systems (CHS) has wrapped a deal to divest its 80% interest in two joint ventures to Vanderbilt University Medical Center (VUMC), the organizations announced Monday morning.
    • “The joint ventures own and operate Tennova Healthcare – Clarksville, a 270-bed hospital with 1,100 staff, and other ancillary businesses in the major Tennessee city. CHS received $623 million before certain transaction expenses for the interests, with CHS also paying $23 million of owed balances to the subsidiaries upon completion of the transaction. 
    • “VUMC, in its announcement, said it will be renaming the hospital and a freestanding emergency room to Vanderbilt Clarksville Hospital and Vanderbilt Emergency Sango, respectively. It also highlighted physician practices in Clarksville plus nearby Dover, Pleasant View and Tiny Town that were included in the deal.”
  • and
    •  “Community Health Systems (CHS) has sold its Commonwealth Health system to nonprofit Tenor Health Foundation, the for-profit chain announced.
    • “The sale, effective Feb. 1, comes just days after the parties received regulatory clearance from the state and in the wake of community and government efforts to keep the facilities open despite financial losses (see that story below). 
    • “The announcement also makes public the three-hospital system’s price tag: $33 million of cash plus a $15 million promissory note from Tenor, with additional cash considerations possible depending on collections of certain patient accounts receivable during the following 90 days.”
  • Healthcare Dive adds,
    • “Healthcare bankruptcies declined in 2025, even as the sector faces financial headwinds on the horizon, according to an analysis published last week by restructuring advisory firm Gibbins Advisors.
    • “The industry recorded 45 bankruptcy filings for debtors with liabilities of at least $10 million last year, down 21% from 2024 — and a steep drop from the 79 cases logged in 2023. However, hospital bankruptcies rose. 
    • “Another year of falling Chapter 11 bankruptcy filings doesn’t necessarily signal financial health in the sector, the report cautioned. Healthcare remains under “significant pressure” as the industry faces looming challenges like historic cuts to Medicaid, according to Gibbins.” 
  • The New York Times tells us,
    • If you wind up at an urgent care center in America, it’s increasingly likely you will be treated by a P.A. For a long time, P.A. meant the same thing everywhere: “physician assistant,” a licensed medical professional who can perform patient care, including prescribing medicine, under the supervision of a doctor.
    • But that might be changing. In Oregon, New Hampshire and Maine, P.A. now means “physician associate,” and other states may follow this year.
    • “Assistant” versus “associate” might sound like a trivial semantic debate, but to many practitioners, and to the American Academy of Physician Associates (which changed its own name in 2021), it’s an important part of the expanding role of P.A.s in health care. * * *
    • “Since 2000, the number of P.A.s has quadrupled, while many parts of the country face a shortage of doctors. That means P.A.s are becoming more numerous — and visible — in all fields of medicine, from primary care to dermatology. And along with the name change, they are seeking the ability to operate more independently from doctors.”
  • Per The Wall Street Journal,
    • “Eli Lilly plans to open a $3.5 billion weight-loss drug manufacturing plant in Pennsylvania’s Lehigh Valley, creating 850 permanent jobs.
    • “Pennsylvania is investing $100 million in tax credits and grants for the project, plus $5 million for a pharmaceutical training center.
    • “Lehigh Valley manufacturing jobs have grown by 28.8% since 2010, triple the national rate, despite recent U.S. manufacturing job contractions.”
  • Per Beckers Health IT,
    • “Oracle Health is expanding its Clinical AI Agent to help clinicians automate the creation of clinical orders during patient appointments.
    • “The tool now supports automated order creation for laboratory tests, imaging and diagnostic studies, new and refilled prescription medications, follow-up appointments and referrals. Oracle Health said in a Feb. 2 news release that the update builds on the product’s existing note-generation feature and uses ambient listening during visits to draft clinical orders for physician review and approval.
    • “The technology is designed to reduce the administrative burden of repetitive manual tasks, such as order entry, which can pull providers away from direct patient care and contribute to burnout.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Medicare, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “Speaker Mike Johnson (R., La.) faces a tougher-than-expected vote to end a partial government shutdown this week, after House Democrats pushing for sweeping changes to immigration enforcement signaled they wouldn’t help Republicans pass any funding measures through the narrowly divided chamber.
    • “Johnson, with a 218-213 majority, will need to keep almost all Republicans on board or risk the shutdown that started Saturday stretching deep into the week. The measure, endorsed by President Trump, funds swaths of the government for the rest of the fiscal year, while providing a two-week extension for the Department of Homeland Security—which contains immigration-enforcement agencies. The extension is intended to jump-start talks on reining in enforcement officials’ practices.
    • “I’m very optimistic that we will get everyone back in town,” Johnson said Sunday in an interview, referring to GOP lawmakers. “We will convince them that we need to implement the president’s play call,” giving the White House time to discuss changes to DHS with Democrats.” * * *
    • “Johnson’s tiny vote margin gives any one or two GOP members powerful leverage if they want changes or concessions. Johnson as soon as Monday is expected to swear in Christian Menefee, a Democrat who just won a Texas special election to represent Texas’ 18th Congressional District after former Rep. Sylvester Turner’s death last year. That will bring the majority to 218-214.”
  • Here’s a link to Roll Call’s take on what to expect to occur on Capitol Hill this week.
  • The American Medical Association tells us,
    • “The influential Medicare Payment Advisory Commission (MedPAC) voted in January to address inadequate payment for Medicare physician services under current law, once again underscoring a longstanding policy failure that is widely recognized but remains unresolved.
    • “MedPAC voted to recommend an additional 0.5% update on top of the updates specified in current law—0.25% and 0.75%—and will forward that recommendation to Congress. 
    • “The AMA appreciates that last year’s reconciliation bill provided a temporary 2.5% update for 2026; however, that increase expires in 2027. Absent meaningful reform, physicians again will face payment cuts, and Congress will once more be forced into last-minute efforts to avert further disruption,” AMA Board Chair David H. Aizuss, MD, said in a statement.
    • “The AMA is leading the charge to reform the Medicare payment system. That includes strongly urging MedPAC to recommend to Congress that they update 2027 physician payment rates so that they keep pace with the Medicare Economic Index (MEI).” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.
    • “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”
    • “The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “There’s been a small but “alarming” bump in aortic stenosis (AS) deaths among people ages 45 to 74 in recent years, according to nationwide trends.
    • “In this younger group, age-adjusted AS mortality rates had been relatively stable until 2019, when they started climbing from a rate of 3.33 per 100,000 to 3.57 per 100,000 in 2023 — a statistically nonsignificant change that is notable nonetheless, according to Sameer Hirji, MD, MPH, of Brigham and Women’s Hospital in Boston.
    • “In comparison, those ages 75 and older showed a consistent decline in age-adjusted AS mortality rates from 2012 (112.3 per 100,000) to 2023 (104.1 per 100,000) based on the CDC WONDER database, Hirji reported at the Society of Thoracic Surgeons (STS)opens in a new tab or window annual meeting.
    • “This emerging trend — spanning sex, race, and geography — demands urgent evaluation of existing screening practices, timely diagnosis, and equitable access to both transcatheter and surgical therapies,” he concluded.”
  • The Washington Post relates,
    • “For years, scientists have been working to unravel the mystery of patients with failing kidneys dying from heart-related complications.
    • “Researchers now say they’ve uncovered a clue that explains why people with chronic kidney disease have such a high risk of heart failure — and it could have major implications for the diagnosis and treatment of the two common health conditions.
    • “A new study found that diseased kidneys released tiny particles that were toxic to the heart, according to findings published recently in the peer-reviewed journal Circulation.” * * *
    • “That molecular discovery is helping to shed light on one way the kidney and heart are linked — and, in this case, to dangerous effect, said Susmita Sahoo, the study’s senior author and an associate professor of medicine at the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai.
    • “No one has shown this causal relationship before,” Sahoo said.” * * *
    • “Sahoo said her team’s findings could help identify heart disease in kidney patients earlier, before they show symptoms.
    • “By measuring these cardiotoxic microRNAs, you can actually predict or identify or diagnose the patient who are on the way to developing a failing heart,” she said.
    • “The research can also influence treatment recommendations, said Erdbrügger, the study co-author who is also a practicing kidney doctor. For instance, Erdbrügger said if she knew one of her kidney patients had a higher risk of heart disease, she would consider treating more aggressively by increasing drug dosages or using more combinations of medications.”
  • The Wall Street Journal tells us,
    • “Federal regulators issued a safety warning, telling used-car owners in the U.S. to examine their vehicles’ maintenance histories regarding air-bag safety.
    • “NHTSA said nine people have died and two were injured in otherwise-survivable crashes after DTN inflaters ruptured.
    • “NHTSA urged drivers who find that their vehicles experienced an air-bag deployment to have an inspection.” * * *
    • “If a DTN inflater is found, the vehicle should not be driven until you are able to have it replaced with genuine parts,” NHTSA said.
  • NPR Shots informs us,
    • “Building strength and muscle comes with huge payoffs for health and longevity, but most Americans still don’t lift weights or regularly practice any muscle-strengthening activity.
    • “Why? People often blame a lack of time.
    • “Exercise physiologist David Behm says often when he talks to people about resistance training they seem to think they’d need hours in the gym to get results, working through rows of machines targeting each muscle.
    • “They’re like ‘my God, I’m going to be in there for an hour and a half or longer,” says Behm, a professor at Memorial University of Newfoundland in Canada.” * * *
    • “The evidence shows you can make real gains in strength and muscle with as little as one or two quick workouts a week — depending on the approach, you might be able to get away with as little as a half hour in the gym (or even less).
    • “The key is focusing on what are called multi-joint exercises, or compound lifts.”
  • The New York Times points out,
    • “A study published this week in the journal JAMA Pediatrics found that a close, nurturing relationship with parents during middle and high school was associated with a variety of positive social metrics up to two decades later.
    • “Researchers looked at six outcomes, such as having three or more close friends or socializing at least once a week. They found that high social connection in adulthood was more than twice as common among those who had felt the strongest family ties in youth, compared with those who had felt the weakest.
    • “We tend to think of adult loneliness or low social connectedness as byproducts of individual choice or adult social structures,” said Dr. Andrew Garner, a pediatrician and researcher at Case Western Reserve University, who was not involved in the research. This study, on the other hand, “forces us to think developmentally.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “2026 is an “execution year” for Teladoc Health, CEO Chuck Divita told Healthcare Dive.
    • “The telehealth company has spent the past year focusing on a strategy shift, prioritizing international expansion, improving operating efficiency, better leveraging its mental health assets and enhancing its integrated care business.
    • “The goal is to deliver sustainable long-term growth at Teladoc, which has seen its stock price decline significantly from the heights reached during the COVID-19 pandemic. To that end, the virtual care giant completed multiple acquisitions last year, launched new products and began accepting insurance coverage at its direct-to-consumer mental health arm BetterHelp. 
    • “I believe that we have the right strategy, the right priorities, and it’s really about execution now,” said Divita, who took up the role as Teladoc’s chief executive about a year and half ago.”
    • For the full interview, read the article. 
  • McKinsey & Co. discusses the changing contours of health and wellness.
    • “As 2026 takes shape, long-held notions of health and wellness, both in and out of the workplace, are evolving—expanding beyond disease prevention to focus on longevity, performance, and quality of life.
    • “Advances in healthspan science are driving biomedical innovations that contribute to healthy longevity, while the rapidly evolving wellness economy reflects shifting consumer expectations around fitness, nutrition, and healthy aging. McKinsey Health Institute research from Barbara Jeffery, Jacqueline Brassey, Lucy Pérez, and Darshini Mahadevia also shows that workplace health interventions can deliver measurable gains for both individuals and organizations. 
    • “As you navigate your own wellness journey this year, explore these insights on what it means to live a healthier, more fulfilling life.”
  • Per Fierce Healthcare,
    • “Maven Clinic launched a research institute on Thursday to rally further research and collaboration in digital health.
    • “The Clinical Research Institute is based on what Maven claims is the largest public evidence base measuring the impact of virtual care on women’s and family health. Maven has published over 40 peer-reviewed publications. A clinical research team, including Maven’s chief medical officer, is part of the center and driving its research and collaborations with partners.
    • “The goal is to serve as a platform for partnerships across academia and industry while expanding the scope of women’s and family health research. Current and past research partners include Harvard Medical School, Brown University, Posterity and OURA, with additional studies planned.
    • “The Institute also advances research through Maven’s Visiting Scientist program. Visiting Scientists work part-time with Maven for up to one year, contributing to research that informs care delivery and helps translate evidence into practice.”
  • and
    • “Nourish, a virtual nutrition provider, is launching a program that gives patients access to free cardiometabolic lab testing. 
    • “Nourish Labs will integrate blood testing into personalized nutrition care. The free basic panel will include key cardiometabolic markers like cholesterol, A1C and thyroid-stimulating hormone. An enhanced lab panel for insights into heart and hormone health will be available for a small add-on cost. 
    • “The objective measurement will improve treatment plans and strengthen patient engagement, executives say.
    • “We had just really wanted to, for a long time, bring it in-house and to be able to do this ourselves,” Aidan Dewar, co-founder and CEO of Nourish, told Fierce Healthcare in an exclusive advanced interview.”