Friday report

Government Contracting

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • “Affordable Care Act plan premiums will rise by 13% in 2027, the second straight year of double-digit increases in a strained market that is already facing shrinking enrollment.
    • “Next year’s boost follows a 26% surge this year and is the second biggest rise since 2018, according to KFF, the health-research nonprofit that calculated the increase based on federal data released Friday.
    • “The hike means an average monthly premium of about $704 for a 40-year-old buying an ACA “benchmark” plan for 2027, compared with $624 this year and around $497 in 2025. Benchmark plans are midtier products in each region that are used to set federal subsidy amounts.
    • “People can start shopping for next year’s ACA plans on Nov. 1. The latest increase will add to the strain for the slice of ACA consumers who pay the full price for their plans. Most people with ACA coverage get the government subsidies, but federal support was reduced sharply at the start of this year, leading millions of people to drop out of the market.” * * *
    • “For the ACA plans, as with other types of insurance, a main driver of higher premiums for next year is the growth in spending in areas like hospital care and drugs, said Cynthia Cox, a senior vice president at KFF.”
  • Here’s a link to the CMS Fact Sheet on this news.
  • Per a CMS news release,
    • ‘The U.S. Department of Health & Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized a rule to help more donated organs reach patients by strengthening oversight of Organ Procurement Organizations (OPOs). OPOs connect donor hospitals and transplant programs by securing authorization for donations, recovering organs, and coordinating safe, timely delivery for transplantation. This rule builds upon President Trump’s 2019 Executive Order, Advancing American Kidney Health, and helps advance a key goal of the Department’s Kidney Care National Plan to reform organ transplantation
    • “While more than 49,000 transplants were performed in the United States in 2025, over 100,000 Americans are waiting for lifesaving transplants. To improve access to transplants, the final rule allows high-performing OPOs to compete for multiple donation service areas, clarifies OPO recertification procedures, and reinforces longstanding process performance standards.” * * *
    • “The final rule is available in the Federal Register at: https://public-inspection.federalregister.gov/2026-22381.pdf. 
    • “View the final rule fact sheet at: https://www.cms.gov/newsroom/fact-sheets/medicare-medicaid-programs-organ-procurement-organizations-conditions-coverage-revisions-conditions.”
  • Beckers Hospital Review reports,
    • “In the first six months of Medicare’s Wasteful and Inappropriate Service Reduction pilot, the use of targeted services fell in participating states relative to the rest of the country, according to a research letter published Oct. 26 in JAMA.
    • “The study, from researchers at the University of Minnesota School of Public Health and Brown University School of Public Health, gives early insights into WISeR. The pilot, which brings AI-enabled prior authorization to traditional Medicare, is taking place for six years across six states, according to CMS.
    • “Compared with trends in other states, monthly epidural steroid injections declined 15%, while other targeted services declined nearly 20%. Services with delayed WISeR implementation served as a negative control, showing no significant change.” * * *
    • “The key question we can’t yet answer is whether the care not received was wasteful or necessary,” Hannah Neprash, PhD, lead author and University of Minnesota School of Public Health associate professor, said in an Oct. 26 news release.” 
  • GSA announced today,
    • “The Federal Acquisition Regulatory Council has released an update to the FAR Companion as part of the ongoing Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26.
    • “FAR Companion, Version 3.0 was posted on October 30, 2026. FAR Companion, Version 3.0, includes:
      • “Embeds a feedback form directly in the FAR Companion;
      • “Captures best practices for industry engagement across the acquisition lifecycle;
      • “Adds guidance on non-federal past performance, contractor self-assessments, performance monitoring, and reprocurement to the next highest-rated offeror;
      • “Includes annotations that cover all RFO smart accelerators and Periodic Table of Acquisition Innovations techniques;
      • “Moves common acquisition practices into FC 7.102(a) for consistency across buying pathways;
      • “Clarifies outcome-based contracting as a subset of performance-based acquisition;
      • “Clarifies use of modular contracting; updates definitions, procedures, and guidance on commercial contracting, including commercial construction contracting;
      • “Expands guidance on construction and architect-engineer contracting; adds guidance on contract closeout and termination settlements;
      • “Provides context on non-FAR based authorities such as OT, SCO, and the SBIR/STTR program; and
      • “Adds relevant program management concepts for improved cross-functional usability; and includes updates to FC parts 5, 6, 7, 11, 15, 24, 32, and 36 based on practitioner and interagency feedback.
    • “To view the FAR Companion, Version 3.0, visit: https://www.acquisition.gov/sites/default/files/page_file_uploads/far-companion.pdf.
    • “To view all available rewritten FAR Parts and agency deviations, visit: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide.”

From the U.S. Office of Personnel Management front,

  • Federal News Network reports.
    • “With two months left for agencies to conduct a required annual assessment of federal employee satisfaction and engagement, the Office of Personnel Management is finalizing major changes to the structure and distribution of the now-defunct Federal Employee Viewpoint Survey.
    • “Following final regulations published Thursday, OPM has formally moved forward with ending the distribution of FEVS, which it has overseen for more than 20 years. Instead, it’s telling agencies to issue their own versions of the workforce survey by the end of the calendar year.
    • “OPM said the changes are meant to make the engagement survey more useful and actionable. But critics of OPM’s changes contend that removing the governmentwide survey will undermine years of comparable workforce data and reduce transparency into the results.
    • “In its final rule, OPM pointed to three large agencies that have already discontinued using FEVS — NASA, the Department of Veterans Affairs and the Securities and Exchange Commission — as evidence that the engagement survey needed to be individualized.

From the U.S. Food and Drug Administration front,

  • Contemporary OB/GYN reports,
    • “The FDA has approved updated labeling for 3 additional menopausal hormone therapy (MHT) products, removing statements on cardiovascular disease, breast cancer, and probable dementia from their boxed warnings, according to an October 30, 2026, release from the US Department of Health and Human Services (HHS). All 3 products are estradiol transdermal patches from 2 applicants, though the FDA did not provide details on brand or manufacturer names.1
    • “The approvals follow the agency’s February 2026 action on labels for 6 MHT products. The FDA began engaging companies on the changes in November 2025, and 29 drug companies have submitted proposed labeling changes to date, the agency stated. HHS added that the latest actions support the executive order “Advancing Women’s Health to Improve Outcomes in All Phases of Life,” signed October 19, 2026.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) that leads to the formation of small, wart-like growths in the patient’s airways. This approval, the first for a plasmid DNA-based immunotherapy in the U.S., offers patients a new therapeutic option that targets the root cause of RRP and has been shown to reduce the burden of surgical intervention, representing an important step forward for a patient population with limited treatment options.” * * *
    • “The FDA granted Voceryq Breakthrough and Orphan Drug designations. The FDA granted accelerated approval of Voceryq to Inovio Pharmaceuticals, Inc.”
  • Cardiovascular Business relates,
    • “Sotagliflozin has been linked to key cardiovascular benefits for a wide range of patients. In fact, the team behind new research published in The Journal of Clinical Investigation believe it may be a “wonder drug” of sorts with untapped potential.[1]
    • “Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor sold by Lexicon Pharmaceuticals under the brand name Inpefa. It first secured U.S. Food and Drug Administration (FDA) approval in 2023 to reduce the risk of heart failure among high-risk patients, including those with type 2 diabetes.
    • “Multiple studies have linked this drug to a reduced risk of adverse cardiovascular events, including one from 2025 that found it may protect patients from heart attack and stroke. To learn more, a group of researchers with the University of Michigan performed a series of experiments focused on learning how, exactly, sotagliflozin achieves these results.
    • “A drug that can both decrease the risk for diabetes along with the risk for having a heart attack or stroke could be a turning point in our ability to safely treat this growing population in the US and abroad,” co-senior author Michael A. Holinstat, PhD, MS, a professor of pharmacology, internal medicine and surgery at University of Michigan Medical School, said in a statement.
    • “Sotagliflozin appears to be in the sweet spot because compounds that have higher levels of SGLT1-selective inhibitors can cause gastrointestinal issues,” added co-author Bertram Pitt, MD, professor emeritus of internal medicine at University of Michigan Medical School. “We think this could be a wonder drug with potential to offer benefit for many conditions.”

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Departments of Labor, Health and Human Services, the Treasury, and the Office of Personnel Management released guidance Oct. 29 for independent dispute resolution entities on batched and bundled items or services, reflecting changes finalized in the No Surprises Act IDR operations rule in May on how qualified IDR items and services can be batched. The guidance explains how the finalized batching requirements will be used and specifies the permissible current procedural terminology code ranges for anesthesiology, radiology, pathology and laboratory items and services considered to relate to the treatment of a similar condition. It also explains the definition of a bundled payment arrangement and provides examples to guide how disputing parties and certified IDR entities should apply the finalized batching and bundled payment provisions.” =
  • STAT News adds,
    • “It was a simple urinary tract infection. A textbook urgent care visit. 
    • “Kristin Gills knew the drill. She peed in the cup, and the doctor confirmed her suspicion. He prescribed antibiotics. Before she left Methodist Legacy ER & Urgent Care in Allen, Texas, Gills paid her $211 bill and figured that was the end of it.
    • “Then the real bill came, for another $1,756.
    • “I was like, ‘What in the world?’ I immediately tried calling them,” she said. When she couldn’t reach anyone, she sent three MyChart messages. Nothing.” * * *
    • “The facility Gills visited doubles as both an emergency room and an urgent care clinic. Intuitive Health, the private equity-backed company that runs the hybrid facility and nearly 50 others like it, says they’re great for patients because they prevent them from having to guess whether their conditions are emergencies. But patients told STAT they visited for what they thought were obvious urgent care issues — coughs, congestion, flu symptoms — and were shocked when they got bills for ER care instead, often totaling thousands of dollars. 
  • FEHBlog observation — This patient must have been cash only because if she had used health insurance the provider would have collected the cost sharing and then proceeded to the No Surprises Act dispute resolution process. It is ironic

From the judicial front,

  • The American Hospital Association News reports,
    • The U.S. District Court for the District of Massachusetts yesterday ruled in favor of 25 states and the District of Columbia to vacate the Centers for Medicare & Medicaid Services’ definition of “medically frail” from its Medicaid community engagement requirements.
    • “The definition would have required medically frail individuals to demonstrate they had a qualifying condition that significantly impairs their ability to comply with the community engagement requirements. The requirements call for certain adults to complete 80 hours per month of “qualifying activities,” such as employment, education, community service or participation in a work program, or meet equivalent income thresholds. In the decision, District Judge Richard Stearns said CMS went beyond its scope in authorizing the provision and narrowing the definition of “medically frail.”  
    • “Because enforcement of an unlawful definition of ‘medically frail’ may lead to the disenrollment of otherwise eligible vulnerable individuals relying on Medicaid coverage for continuity of care, the States (and public) face potential for great hardship in the absence of an injunction,” Stearns wrote. The remaining provisions under the community engagement requirements will be enforced beginning Jan. 1, 2027.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19, flu, and RSV are key indicators of overall respiratory illness activity
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country.
    • “COVID-19 activity is declining nationally.
    • “Seasonal flu activity remains low nationally but is increasing in many parts of the country.
    • “Rhinovirus/Enterovirus (RV/EV) is elevated but decreasing nationally, and human parainfluenza viruses (PIV) are increasing.”
  • The University of Minnesota’s CIDAR adds,
    • It used to be that 200-plus US measles cases would reflect the total for the year or even for two years, but the Centers for Disease Control and Prevention (CDC) today confirmed 264 new cases in just the past seven days, raising the country’s total to 4,852 cases, by far the highest yearly total in 35 years.
    • “The new data mark the 12th straight week of triple-digit increases nationwide. Rising cases in multiple states have contributed to the escalation, but Pennsylvania continues to be the nation’s hot spot, logging 88 new cases this week, followed closely by Wisconsin.
    • “The United States will very likely lose its measles elimination status—which it gained in 2000—in the coming month. Even an analysis published in May, when the country had only around 1,800 cases, said as much.
    • “The CDC has logged 43 measles outbreaks across the country so far this year, compared with 48 for all of last year, which saw 2,289 cases by year’s end. An outbreak involves three or more people. All but 18 infections this year have been locally acquired, with the rest involving international travelers.
    • “Of the confirmed cases, 17% have been in children under the age of 5 years, and 41% have been in kids and teens ages 5 to 19. Eleven percent of cases overall have required hospitalization, a number that has been slowly climbing and now matches the 2025 rate. Hospitalization rates are highest in preschoolers (16%), with a 14% rate in adults 20 and older.”
  • and
    • “Measles is highly contagious, and quickly identifying who is infected is critical from a public health perspective: Delays lead to additional cases since patients, caregivers, and clinicians won’t know to take precautions to prevent viral spread. 
    • “Yet an estimated 6.9% of patients with measles who sought medical care were misdiagnosed at least once in the two weeks before an accurate diagnosis, according to a study published this week in Infection Control and Hospital Epidemiology. 
    • “While the findings suggest these errors are not common, the University of Iowa authors argue the study shows the need to consider early measles testing among patients with respiratory symptoms.
    • “The risk of transmission is increased when patients spend time in busy waiting rooms or clinics, because virus aerosols remain airborne for hours,” said the authors, led by biostatistician Alan T. Arakkal, PhD.” 
  • The American Medical Association lets us know what doctors want patients to know about sciatica.
    • “A sharp, shooting pain that starts in your lower back can be a sign of sciatica. Learn what causes sciatica, how long it lasts and when to see a doctor.”
  • Contemporary OB/GYN relates,
    • “The American College of Obstetricians and Gynecologists (ACOG) has issued a practice advisory recommending that ob-gyns counsel patients on the lack of sufficient safety data for glucagon-like peptide-1 receptor agonists (GLP-1RAs) in pregnancy, advise considering discontinuation 1 to 2 months before conception, and advise against use during pregnancy. For lactation, the guidance supports shared decision-making on a postpartum care plan that may include GLP-1RAs, with close surveillance of neonatal weight gain, and recommends against use in individuals breastfeeding or chestfeeding preterm infants and neonates.
    • “Prescribing of GLP-1RAs in the perinatal period increased more than 30- between 2019 and 2024, according to a large retrospective cohort study cited in the advisory. The long half-lives of semaglutide, tirzepatide, and dulaglutide make avoiding the medication during pregnancy more challenging, and because GLP-1RA-associated weight loss may improve fertility, patients who can become pregnant should be counseled on effective contraception.
    • “Currently, as many as 1 in 300 women are exposed to GLP-1s prior to pregnancy,” said D. Yvette LaCoursiere, MD, FACOG, lead author of the guidance, in an ACOG news release. “This is a fast-moving area of research, so for now we need to proceed with caution and reassess as more data becomes available.”
  • Beckers Behavioral Health tells us,
    • “The share of U.S. children and adolescents ages 5-17 who have ever received an attention-deficit/hyperactivity disorder diagnosis rose from 9.9% in 2019 to 13.8% in 2025, according to CDC data published Oct. 29.
    • “The CDC’s National Center for Health Statistics released the findings as a QuickStats feature in the Morbidity and Mortality Weekly Report.
    • “Nazik Elgaddal of the National Center for Health Statistics wrote the analysis, which draws on National Health Interview Survey data from 2019 through 2025. The estimates measure whether a child had ever received an ADHD diagnosis, not whether the condition is currently active or under treatment. The CDC also published a supplementary table with year-by-year figures by sex.”
  • and 
    • “Calls to the Washington Poison Center involving kratom and one of its active compounds, 7-hydroxymitragynine, or 7-OH, rose 433% over the past three years, with the sharpest increase in 2026, CBS affiliate KIRO 7 News reported Oct. 29.
    • “The center logged 176 kratom- and 7-OH-related calls through the end of September, ranging from overdoses to withdrawal cases. In September, the center received calls nearly every day.
    • Jimmy Leonard, PharmD, chief clinical officer at the Washington Poison Center, “told KIRO that 7-OH is “essentially an unregulated opioid” that can slow or stop breathing and may cause death. Dr. Leonard said he is particularly concerned about accidental exposures in children because some 7-OH products come as small, candy-like tablets in flavors such as Sour Strawberry and Blue Razz. A few children have required naloxone, he said.
    • “Washington has no statewide kratom regulations and no statewide minimum purchase age. Cities including Bellingham, Mount Vernon and Spokane have enacted local bans. Nationally, 33 states have adopted some form of kratom regulation and nine have banned it, according to the American Kratom Association.
  • Health Day informs us,
    • “Nicotine pouches are catching on in the U.S., as increasing numbers of Americans try and become regular users of the non-tobacco products, a new study says.
    • “More than 1 in 10 Americans (10.2%) have tried a nicotine pouch, researchers reported Oct. 28 in the journal Addiction.
    • “Further, among tobacco users — people who already smoke, vape or use chewing tobacco, for example — about 1 in every 10 were using nicotine pouches in 2024. That’s more than triple the 3% of tobacco users who were using them in 2021, the study says.
    • “That’s a swift increase, given that the pouches only hit U.S. markets a decade ago, in 2016, researchers said.
    • “Our data show that what was once considered a niche nicotine product is becoming a mainstream product among U.S. adult tobacco users,” said lead researcher Ashley Merianos, a professor of human promotion and education at the University of Cincinnati.”
  • Medscape points out,
    • “Waiting times for an initial neurology appointment for memory concerns average more than 4 months, potentially delaying diagnosis and treatment.
    • “In a nationwide telephone survey of 150 neurology clinics nationwide, researchers found that wait times averaged 21.1 weeks at specialized centers and 15.6 weeks at community neurology clinics. Forty-one clinics reported wait times of at least 6 months, and five were not accepting new patients.
    • “A wait of more than 4 months for a first visit is one step in an already long path to diagnosis, and it pushes back the testing, diagnosis, and treatment planning that start at that visit,” study investigators Jennifer C. Knox, MS, and Jeremy J. Pruzin, MD, of the Banner Alzheimer’s Institute in Phoenix, told Medscape Medical News in an email.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Insurers are rolling out commercial offerings for 2027, and many are navigating a landscape of greater affordability pressures on employers and, ultimately, their employees. 
    • “Professional services firm Aon projected that average employer healthcare costs could surpass $19,000 per employee in 2027, a 9.5% increase. Between 2025 and 2026, employee premiums increased by 6.4%.
    • “Some commercial payers are introducing products designed to give employers another option beyond HMOs and PPOs: exclusive provider organizations, or EPOs.
    • “An EPO offers a strong middle ground between a PPO and an HMO,” Chris Fanning, executive vice president and chief commercial officer at Independence Blue Cross, told Becker’s in a statement. “Members have access to a broad network of providers and can see specialists without referrals, while employers can often realize cost savings because coverage is generally limited to in-network care. We already offer a range of PPO and HMO options, and EPOs give employers another choice to meet the needs of their workforce.”
  • Beckers Hospital Review relates,
    • “Sacramento, Calif.-based Sutter Health has scrapped plans to build a hospital on its Emeryville, Calif., property. The system cited regulatory uncertainty and the risk of litigation as the main reasons.
    • “The most significant barrier was the lack of a clear and predictable regulatory path,” Sutter said in an Oct. 30 statement. “Over two years, we pursued relief under the California Environmental Quality Act, or CEQA. Those efforts did not secure the certainty needed to advance the hospital project, leaving it vulnerable to litigation that could delay construction and new hospital services for years.”
  • and
    • “Livonia, Mich.-based Trinity Health is working to make primary care, rather than the emergency department, the main way patients enter its system, executives said during the system’s fiscal 2026 investor call Oct. 26. 
    • “Health systems have historically treated the emergency department as the primary entry point to care, said Ray Anderson, PhD, executive vice president and chief strategy officer. 
    • “We’re looking to flip that pyramid upside down and really have primary care be the most important entry point,” he said.
    • “Dr. Anderson said routing patients from primary care to specialists and then to community-based services brings in more elective patients who are “choosing us,” creates a more balanced payer mix and makes the system less dependent on seasonal swings in emergency volumes.”
  • Fierce Pharma tells us,
    • “Facing looming patent cliffs, AstraZeneca has launched a restructuring initiative aimed at generating $1.5 billion in annual savings by 2029.
    • “Savings from the “Reshaping for Sustainable Growth” program will be reinvested “principally in the pipeline,” AZ said Friday in its third-quarter earnings announcement.
    • “The company expects the three-year initiative to incur up to $2 billion in one-time restructuring costs.”
  • and
    • “Prescriptions for Eli Lilly’s Foundayo and Novo’s Wegovy pill ticked back up last week, although neither matched previous records.
    • “Foundayo enjoyed 63,110 total scripts in its 29th week of launch, still shy of its 64,268-script record set in week 25, according to IQVIA data cited by Citi. 
    • “The Wegovy pill’s roughly 183K scripts also came slightly below the 184K height it had briefly reached five weeks ago. During the week, the oral version of Novo’s obesity med constituted 36% of all Wegovy scripts.
    • “Approximately 4 in 10 patients starting an oral obesity medicine choose Foundayo, and the number of new Foundayo patients in the third quarter doubled from the previous quarter, Lilly’s CFO said on the company’s Q3 earnings call Thursday.
    • “In Q3, Foundayo sales reached $184 million, including $124 million from the U.S., missing consensus estimates by $50 million, according to a Jefferies note. Still, Lilly’s stock price jumped during Thursday’s earnings report, “which to us suggests investors are increasingly focusing on the breadth and depth of [Lilly]’s obesity franchise rather than near-term Foundayo [numbers],” Jefferies’ analysts said. Sales from both of Lilly’s tirzepatide products, Mounjaro and Zepbound, came in above Wall Street’s projections during Q3.”
  • MedTech Dive shares “three highlights from EY’s report on 2026 medtech trends.”
    • “M&A rose, but company valuations declined in the first half of 2026 compared with the year-ago period, according to EY’s Pulse of the Industry report.”
  • MedCity News informs us,
    • “Direct-to-consumer diagnostics are becoming increasingly popular. But what’s driving the rise of consumer diagnostics? This was the topic of conversation during a Thursday panel at the MedCity INVEST Digital Health conference in Dallas.
    • “One panelist — Leo Grady, CEO of gut microbiome testing company Jona — noted that people have been interested in analyzing themselves for a long time. Genetic testing company 23andMe started about 20 years ago, and Everlywell made home testing mainstream, he said. But Covid-19 really drove the rise in at-home diagnostics.
    • “I think it was partly driven by the fact that everybody was home, partly because health became more on your mind, and also partly because of some of the regulatory relaxations that happened that made it more possible to ship tests across state borders, to have more clinical-grade tests prescribed without having them to come from your doctor,” he said. “That really standardized and made more mainstream the ability for people to access tests and to then be able to get those results and even talk to medical professionals online.” * * *
    • “Pita Navarro, chief scientific officer of Evvy, noted that the women’s health space has seen slower growth than other areas. Evvy is a vaginal microbiome testing company.
    • “I think for me as a scientist and going through Covid specifically, I was watching the vaccine develop within months, the causing agent identified within months as well. And yet, I was going to the OB/GYN, and they were counting shapes under a microscope. And so we thought, ‘We have this new technology; why isn’t it being applied in women’s health as it’s being applied across the healthcare system?’”
    • “She added that this was a major driver for the creation of Evvy. Vaginal health is a leading reason that women seek healthcare advice, and if a female goes to an OB/GYN, they’re more likely to get misdiagnosed than correctly diagnosed, Navarro said. The vaginal microbiome is also predictive of numerous outcomes across the lifespan, including cervical cancer, sexually transmitted infection and infertility.”

Thursday report

David Ermer–Agentic & Generative AI, AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue

From Washington, DC

  • The Wall Street Journal reports,
    • “Newly installed Centers for Disease Control and Prevention Director Dr. Erica Schwartz said she wants to change a culture of “paternalism” at her agency.
    • “Americans need to be better informed about how and why the CDC makes its recommendations, and the agency needs to be willing to listen to people’s concerns, she said. 
    • “There is a sense of paternalism that we have had at the CDC,” Schwartz said. “It shouldn’t be this black box that we say, ‘Verily thou shalt, and then that’s the answer.’”
    • Schwartz made the comments Wednesday at a Wall Street Journal Future of Health event in Washington, D.C.
    • “Schwartz said Wednesday that parents should prioritize receiving measles vaccines for their children amid current U.S. outbreaks, saying the shot is “absolutely safe, absolutely effective.” She defended the secretary, a skeptic of vaccines who has said they are a “personal decision,” saying he channels concerns from parents who are wary of the full slate of childhood immunizations.
    • “The secretary does represent the voices of a number of Americans who are asking questions about certain vaccines,” she said, adding that doctors shouldn’t approach vaccine-skeptical parents with “a paternalistic way of thinking.”
  • Casey B. Mulligan, HHS chief economist and chief regulatory officer, writes in STAT News,
    • “Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
    • “Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
    • “A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.” * * *
    • “On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.
    • “For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.” * * *
    • “Medicare patients should not pay coinsurance as though the discount did not exist.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) this week launched a series of actions to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.
    • “To address health problems Americans report after vaccinations, HHS:
      • Opened a new National Institutes of Health (NIH) clinic dedicated to studying and caring for patients experiencing health problems following vaccination;
      • Proposed reimbursing physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new Centers for Medicare & Medicaid Services (CMS) policy, bringing vaccine reporting in Medicare in line with typical Medicare reimbursement policies;
      • Will require electronic health records to capture vaccine-related adverse events so that information can follow patients across the health care system; and
      • Is modernizing the Centers for Disease Control and Prevention’s (CDC) VAERS to make reporting simpler and improve the tools available to researchers and medical professionals investigating potential safety signals.
    • “We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”
  • Beckers Hospital Review informs us,
    • “The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
    • “The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
    • “The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
    • “The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. Safety groups ECRI and ISMP warned after the vote that gaps in safety and efficacy data remain unresolved.”
  • The American Hospital Association News points out,
    • “The Department of Homeland Security Oct. 8 issued a proposed rule that would establish new fees for foreign students seeking Optional Practical Training, a program that allows F-1 students to work in the U.S. in positions related to their field of study after graduation. Specifically, DHS proposes a fee of $70,000 for an initial OPT authorization and $30,000 for any subsequent OPT authorization, citing concerns about fraud, program integrity and protection of U.S. workers. The agency is accepting comments through Nov. 9.
    • “The proposal could have significant implications for hospitals and health systems that rely on international graduates, including nurses, physicians, pharmacists and other healthcare professionals, as OPT often serves as a pathway into the healthcare workforce. The AHA will review the proposed rule and evaluate its potential impact on workforce recruitment and retention.”
  • and
    • “The Agency for Healthcare Research and Quality Oct. 7 announced the launch of the Super Intelligence for Healthcare Improvement Initiative, a two-part artificial intelligence competition focusing on medical evidence reviews and data. The first competition, called the Clinical Evidence Synthesis Transformation Challenge, aims to reduce analysis times from a year or longer to hours. This competition consists of two phases, where up to five finalists will receive $100,000 each after the first, and one winner will receive $5.35 million following the second. The challenge submission period will run from Jan. 11 to March 12, 2027.
    • “The next part of the initiative, called the SI Tech Sprint for Healthcare Research and Implementation Quality and Safety, aims to use AI to leverage AHRQ’s cost, utilization and quality databases to establish an AI-enabled ecosystem of applications for research, quality improvement and public access. The total prize pool is $2.1 million for selected winners. Submissions will be accepted from March 1 to Sept. 9, 2027. AHRQ’s webpage for the competition provides additional details, including information on registration, resources and an FAQ.”

From the U.S. Office of Personnel Management front,

  • FedWeek reports,
    • “Federal employees who have been watching the government’s renewed focus on reductions in force (RIFs) should pay close attention to one development in particular: newly finalized changes that make performance ratings far more important in determining who stays and who goes.
    • “These regulations are now final law and apply to any agency issuing a specific RIF notice on or after September 2, 2026. As a result, many employees will find that their last several performance appraisals carry greater weight in whether they keep their jobs. That means the time to review your record is now, not after an RIF notice arrives.
    • “This article is not legal advice for any individual employee. But it outlines practical steps federal employees can take now to protect their retention standing, preserve appeal rights, and avoid being caught flat-footed under OPM’s finalized RIF framework.”
  • Federal News Network relates,
    • “There’s a new way to look at data about the federal workforce. The Office of Personnel Management has launched an AI chatbot to answer the public’s questions about workforce trends. The new feature has been added to OPM’s “federal workforce data” website, which details employment numbers and other information about the civil service. Users can enter questions and get AI-generated answers about government hires and separations, as well as workforce demographics like age, veteran status and education level. — Drew Friedman(FWD Chat – Office of Personnel Management)”
  • Edward Zurndorfer, writing in My Federal Retirement, discusses “The Biggest Medicare Mistakes That Can Cost Federal Retirees.”
  • Tammy Flanagan, writing in Govexec, advises “Don’t let 5% become your TSP retirement strategy.”
    • “Getting the full agency match is a good baseline, but if retirement is around the corner there’s more to consider before deciding what to do with the rest of your paycheck.”

From the U.S. Food and Drug Administration front,

  • NBC News reports,
    • “The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
    • “In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said. 
    • “Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.” * * *
    • “The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
    • “The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
    • “In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.”
  • Food Safety relates,
    • “The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204),  for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. 
    • “FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”
  • MedPage Today tells us,
    • “The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday.
    • “The notice follows an announcement in April that the agency halted patient enrollment in the phase III ENIGMA-TRS 2 trial after the sudden death of a participant in an evenamide clinical trial. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added.
  • Cardiovascular Business informs us,
    • “Houston-based Leader Formulas is recalling one lot of its Rapture Preworkout dietary supplement due to the presence of 1,3-dimethylamylamine (DMMA), an ingredient not listed on the product label. 
    • “DMMA, often referred to as “geranium extract,” has been linked to a heightened risk of high blood pressure. It is also known to lead to certain cardiovascular problems, including heart attack, shortness of breath and chest pain. Its presence was first identified by the U.S. Food and Drug Administration (FDA) during a routine test. 
    • ‘This voluntary recall includes three different products—Rainbow Twist, Electric Lemonade and Berry Mojito—that were all part of lot 260327-4.
    • “Consumers who have purchased the Rapture Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund,” according to Leader Formulas statement.”
  • Beckers Hospital Review adds,
    • “The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
    • ‘The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
    • “The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.” * * *
    • “Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.”

From the Medicare Advantage front,

  • In a CMS fact sheet, CMS published 2027 Medicare Advantage and Part D Star Ratings.
    • “The information included in this Fact Sheet is based on the 2027 Medicare Advantage (MA) and Part D Star Ratings published on the Medicare Plan Finder on Oct. 8, 2026. For details on the methodology of the MA and Part D Star Ratings, please refer to the 2027 Part C & D Star Ratings Technical Notes available at http://go.cms.gov/partcanddstarratings.”

No Surprises Act News,

  • Bloomberg Law reports,
    • “Insurers and providers share common concerns about ineligible claims under a federal surprise billing law, bolstering Senate HELP Committee Chair Bill Cassidy’s push for a legislative fix before he leaves Congress, Erin Durkin and Victoria Knight report.
    • “The No Surprises Act, a 2020 statute designed to protect patients from unexpectedly large bills from emergency rooms and other out-of-network providers, established an arbitration process for payment disputes between providers and insurers. A flood of ineligible claims is clogging that process — and closed-door meetings convened by Cassidy have put the issue on the table as a shared concern
    • “Cassidy says he’d like to put out legislation before he departs the Senate at the end of the year. While time is running short, the veteran legislator signaled the issue is gaining traction.
    • “Believe it or not, there’s common ground there,” Cassidy said.”
  • STAT News adds,
    • “A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
    • “After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.”
  •  FEHBlog observation — Good luck, Rep. Pallone.

From the fraud, waste and abuse front,

  • NextGov reports,
    • “The Centers for Medicare and Medicaid Services is exploring a new contract operating model and technologies so that the agency can more effectively prevent fraud, instead of chasing after money already in the hands of bad actors, according to documents posted on SAM.gov Monday.
    • “CMS has traditionally contracted with private companies to boost its investigative capabilities and support administrative actions, such as imposing payment suspensions, according to the listing. But under a draft operating model, CMS wants to take a greater role in leading the development, prioritization and direction of those investigations, the website adds.
    • “The old model “worked in the past but new technology and new techniques mean it is time to see if it still works as well,” Kimberly Brandt, a CMS Deputy Administrator, posted on LinkedIn.
    • “Under the draft model, CMS would assign fraud investigations to contractors whose primary role is to develop the investigation and administrative actions under the agency’s oversight, according to a draft Statement of Objectives posted on SAM.gov.”
  • Per a Justice Department news release,
    • “Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division (the Fraud Division) today released Directive 26-13, outlining the Division’s comprehensive approach in the fight against fraud.
    • “Expanding on earlier guidance regarding the Division’s priorities (available here) and corporate enforcement policy (available here), Directive 26-13 sets out the Division’s prosecutorial methodology for investigating, disrupting, and prosecuting fraud. This directive marks a significant operational shift, requiring the Division’s prosecutors to attack fraud from all angles using the Division’s tax, securities fraud, consumer fraud, and cybercrime authorities.
    • ‘This directive also requires Division prosecutors to deploy early, pre‑indictment asset seizures and digital‑infrastructure takedowns to halt fraud schemes and freeze assets in real time. Finally, this directive urges Division prosecutors to develop practice cooperators, zealously prosecute corporate bad actors, seek arrest and detention in appropriate cases, and deliver fulsome advocacy at sentencing. This new, comprehensive approach will drive the Division forward in its mission to preempt, disrupt, and dismantle fraudulent networks before they can inflict widespread harm.
    • “Read the full memo here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Taylor Farms, the produce giant linked to last summer’s deadly cyclospora outbreak, is suspending sales of iceberg lettuce from central Mexico during the parasite’s peak season. 
    • “Chief Executive Bruce Taylor said the company won’t sell iceberg lettuce in the U.S. or Canada that was harvested or processed in the region between May 1 and Aug. 31, starting next year. The period covers central Mexico’s rainy season, Taylor said, and it matches the time when the Centers for Disease Control and Prevention sees an increase in illnesses caused by the cyclospora parasite. 
    • “The company hasn’t determined when the suspension will be lifted.”
  • Reuters relates,
    • “Centers for Disease Control and Prevention Director ​Erica Schwartz said on Wednesday the risk to the US ‌from an unconfirmed pneumonic plague case in Siberia was extremely low, but the agency was prepared to monitor and screen travelers.
    • “We are working with Department of Homeland Security, ​working (with) Department of State, Department of War, and other agencies within ​the government to make sure that we know exactly if ⁠anyone from that area comes into the United States,” Schwartz said at ​the Wall Street Journal’s The Future of Health event in Washington.”
  • and
    • “Using artificial intelligence, researchers may have found a way to make vaccines based ‌on mRNA technology, such as Moderna’s (MRNA.O) and Pfizer’s (PFE.N) COVID shots, storable at room temperature, which would lower costs and make them available in regions where ultra-cold storage is not possible.”
  • and
    • “AI may improve doctors’ ability to detect heart transplant rejection without surgery and appeared to be more accurate than standard blood tests, according to a report in Journal of Heart and Lung Transplantation.”
  • Fierce Healthcare adds,
    • “Utah is expanding the state’s AI regulatory sandbox program with new pilots to test AI-supported prescription renewals, dermatology and physical therapy, while stepping up physician oversight and adding independent third-party evaluators.
    • “Utah is bringing the Utah Department of Health and Human Services, Intermountain Health, University of Utah Health, medical licensing officials and outside experts into the state’s AI policy process. State officials and health systems leaders say the initiative is designed to test AI in real-world clinical settings, generate evidence on its benefits and risks and address key questions around liability, privacy and regulation.”
  • The Washington Post tells us,
    • “Brandon Luu began thinking about the body’s circadian machinery as a teenager, when he was routinely unable to fall asleep until late, sometimes well past 2 a.m. The schedule made mornings miserable and school harder.
    • “But it also left him with a question: What happens when the body’s sense of time falls out of sync with the world around it?
    • “Fifteen years later, Luu is exploring that question through one of psychiatry’s most common disorders: attention-deficit/hyperactivity disorder (ADHD). Sleep problems have long been seen as a consequence of the condition. But now researchers are looking at the possibility that the relationship might run in reverse: that disruptions to circadian rhythms — the biological machinery governing when we sleep and wake — might be a cause.”
  • MedPage Today notes,
    • “Adults with ADHD had substantially higher risks of mild cognitive impairment or dementia.
    • “Genetic ADHD risk predicted cognitive impairment, supporting an association beyond clinical diagnoses.
    • “Findings do not prove a causal link; treatment effects and other variables require further study.”
  • Beckers Clinical Leadership informs us,
    • “Suicide became the 10th-leading cause of death in the U.S. in 2024, up from No. 11 in 2023, according to final mortality data from the CDC’s National Center for Health Statistics. Suicide deaths fell 1% over the same period, from 49,316 in 2023 to 48,824 in 2024, and accounted for 1.6% of all deaths in both years. Suicide’s move into the top 10 happened as COVID-19 deaths declined 37%, dropping COVID-19 from 10th to 15th.
    • “Recent data show patterns that differ by method, age and geography. Gun suicides reached record levels for a fifth straight year even as the overall suicide rate trended down. Emergency department visits for suspected suicide attempts declined among adolescents but rose among adults 26 and older. In 2025, rates ranged from 5.3 per 100,000 in the District of Columbia to 31 in Alaska. At the same time, researchers, children’s hospitals and states are pursuing a range of prevention approaches, from smartphone-based risk forecasting and universal ED screening to firearm access laws.
    • [The article notes] seven things to know about the state of suicide in the U.S.
  • The National Cancer Institute points out,
    • “Mutations in a family of genes called RAS, and the rogue proteins they produce, help drive roughly a third of all cancers, including more than 90% of pancreatic cancers. Yet RAS has long been one of the most elusive drug targets in cancer research. Unlike other proteins targeted by cancer drugs, RAS proteins have relatively smooth surfaces, with no obvious place for a drug molecule to bind. That made RAS notoriously “undruggable.” 
    • “Despite the long odds, federally funded research continued to push the field forward. Researchers eventually revealed the structure of RAS proteins and how they function, and those insights led to new approaches for blocking mutant RAS, particularly KRAS, which is involved in the vast majority of RAS-driven cancers.
    • “Today, three RAS inhibitors—sotorasib (Lumakras), adagrasib (Krazati), and, most recently, daraxonrasib (Rasonque)—are helping patients live longer, and many additional molecules that block mutant RAS are moving through the research pipeline.”
    • “These life-changing drugs would not have been possible without the sustained public investments that laid the groundwork for the field, said Harold E. Varmus, M.D., former Director of the National Cancer Institute (NCI) and the National Institutes of Health, who launched NCI’s RAS Initiative.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Hospitals continue to shift care to outpatient settings, according to a new analysis of data from the first half of the year by Strata Decision Technology.
    • “As a result, hospitals are seeing sicker patients in their inpatient wards as they send lower-acuity patients to outpatient departments. 
    • “Patients in some service lines, like gynecology, had procedures done less in hospitals as minimally invasive surgery options in outpatient settings grew. However, other service lines like breast health saw more, sicker patients in the hospital, likely due to an increase in breast cancer testing and diagnoses, according to the data.”
  • Beckers Hospital Review relates
    • “In early January, Tamar Goldblatt was named vice president of payer revenue strategy and contracting at St. Louis-based Ascension. 
    • “Since then, Ms. Goldblatt has worked closely with system and ministry leaders to understand the distinct needs of each market and align them with Ascension’s broader payer strategy. Her work comes at a time where Medicare Advantage instability, rising denial rates and growing administrative burden have turned once-routine payer discussions into high-stakes negotiations. 
    • “Becker’s connected with Ms. Goldblatt to discuss her top priorities nearly one year into the role, the trends that are reshaping payer partnerships and how she approaches payer collaboration.”
  • and
    • “CVS Health unveiled its first pharmacy-focused CVS Pharmacy in the Boston area Oct. 7. The site is meant to expand access to medications, immunizations and other pharmacist-provided services in the community.
    • “Nearly 20 pharmacy-focused locations will open in select communities across the country in 2026. The sites average about 3,000 square feet and include a full-service pharmacy with a limited selection of over-the-counter products.
    • “CVS has already opened pharmacy-focused locations in Birmingham, Ala., Chicago, Detroit, Houston and Washington, D.C. The company also plans to open more than 40 new CVS Pharmacy locations this year, including traditional stores and pharmacies inside Target stores. CVS cited its 2025 Rx Report, which found 80% of patients prefer face-to-face pharmacy care and 48% would switch pharmacies if limited to digital-only options.”
  • The Wall Street Journal tells us,
    • “Viatris VTRS has agreed to buy pain-drug maker Pacira BioSciences PCRX for $1.65 billion in a deal that expands the healthcare company’s medicines portfolio.
    • “Viatris on Thursday said it would pay $36.50 a share in cash for Pacira, a roughly 45% premium to Wednesday’s closing price of $25.20 for the Brisbane, Calif., company.
    • “The deal is slated to close by the end of the year.
    • “Shares of Pacira were recently up 44% at $36.33 in premarket trading, while shares of Viatris edged down 0.1% to $17.47.
    • “Viatris said the addition of Pacira’s Exparel and Zilretta products to its proposed meloxicam treatment for moderate-to-severe acute pain, positions the Canonsburg, Pa., company as a leader in non-opioid pain-management therapies.”
  • and
    • Argenx ARGX shares fell sharply after the biotech company stopped a late-stage clinical trial of its Vyvgart drug due to lack of efficacy for the treatment of autoimmune condition Sjogren’s disease.
    • “Shares in Argenx were down 18% in European morning trading Thursday, wiping out the stock’s gains in the year to date. If sustained until close, this would be the stock’s biggest one-day percentage drop since December 2023.
    • “The Amsterdam-based company said it would discontinue the study following the recommendation from an independent data-monitoring committee, which concluded that the trial would fall short of its primary goal.
    • “The study evaluated the effects of Vyvgart in subcutaneous formulation in adults with moderate-to-severe Sjogren’s disease, a chronic autoimmune disorder that can cause symptoms including dry eyes and mouth, fatigue and joint pain. No new safety signals were identified in the trial, and safety data were consistent with the drug’s known profile, Argenx said.”
  • BioPharma Dive adds,
    • “On Wall Street, a major search is underway to find struggling public companies that can serve as the raw materials for a niche but booming business. A promising candidate may have just emerged.
    • “This business revolves around “reverse mergers,” a type of deal where a private company combines with a public counterpart, often as a quick way to access the broad and deep-pocketed array of investors found on marketplaces like the Nasdaq. While previously disparaged, reverse mergers have recently become so popular that some deal experts question whether there are enough quality “shell” companies to meet the demand.
    • “Shell hunters could have another option following a Tuesday announcement from Caribou Biosciences, the once high-flying biotechnology startup co-founded by CRISPR gene editing pioneer Jennifer Doudna. In a statement, Caribou CEO Rachel Haurwitz said the current financing environment has made it “increasingly challenging” to secure the money needed to advance the company’s two main research programs, which focus on a hard-to-make form of medicine known as “off-the-shelf” cell therapy.” * * *
    • “To Daina Graybosch, an analyst at Leerink Partners who covers Caribou, the natural end for the company now is either a reverse merger or an acquisition by Tang Capital, a San Diego-based investment firm that made a name for itself by buying up cash-rich biotechs and returning much of their value to shareholders. Caribou ended the second quarter with $114 million worth of cash, cash equivalents and marketable securities.”

Friday report

David Ermer–CDC, CMS, FDA, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Avalere Health offers insights concerning HHS Secretary’s decision to fill out the membership of the U.S. Preventive Services Task Force announced yesterday.
    • “For life sciences companies and health plans, the USPSTF’s ability to resume its work—and potential new approaches to evidence review with its new members—will be consequential. The Task Force’s recommendations influence preventive care practice, clinical quality strategies, and, most notably, health plan preventive service coverage requirements.” * * *
    • “Health plans should prepare for the potential release of delayed recommendations and for a more active USPSTF agenda. This includes maintaining processes to assess coverage requirements, benefit configuration, coding, provider-network capacity, member communications, and implementation timelines once final A or B recommendations are issued. USPSTF last shared a recommendation update in August 2025, with four topics pending final recommendation statements.
    • “As the Task Force resumes activity under new leadership and a substantially different membership profile, transparency, methodological consistency, and implementation relevance will be central to maintaining trust in its recommendations.”
  • Per a Centers for Medicare and Medicaid Services (CMS) news release.
    • “The Centers for Medicare & Medicaid Services (CMS) is working to end skyrocketing drug costs as the agency announces today that all 50 states, plus the District of Columbia and Puerto Rico, have applied to participate in an initiative which provides most-favored-nation pricing for certain prescription drugs to people with Medicaid. Forty states and Puerto Rico have already signed agreements to participate in this historic program that will lower Medicaid drug costs to what other countries pay, saving an estimated $64.3 billion in taxpayer dollars over the next ten years, while preserving or enhancing beneficiaries’ quality of care.” * * *
    • “The GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model is a landmark CMS Innovation Center initiative designed to not only lower drug spending in Medicaid but also improve quality of care and health outcomes by increasing access to critical medications and strengthening the Medicaid program overall. Under the GENEROUS Model: 
      • “Participating manufacturers will make covered outpatient drugs available at most-favored nation pricing to participating state Medicaid programs.
      • “Under agreements with states, participating manufacturers will be invoiced by states for supplemental rebates to effectuate international prices. CMS will monitor pricing accuracy. CMS will share in rebates with states via a reduction in the federal share of Medicaid payments.” * * *
    • “Remaining states have until Sept. 30, 2026, to sign agreements with CMS to participate in the model. The GENEROUS Model launched in January 2026 and runs for five years.
    • “For information on states participating the GENEROUS Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/generous.” 
  • In today’s Federal Register, the Federal Acquisition Council promulgated proposed rules implementing the Revolutionary FAR Overhaul’s (RFO) FAR provision deviations.
  • The FAR Council explains on the acquisition,gov website,
    • “The RFO Phase 2 rule-making process has been organized in 12 FAR Cases, as outlined in the chart. The FAR Council has published Proposed Rules (PR) for the first 4 of 12 RFO-related FAR cases.
    • “With this publication, it’s the perfect time to show how public feedback informed key changes from the model deviations to the proposed rules. Your voice made a difference. The FAR Council received almost 1,600 valuable comments, primarily from industry (80%), but also from industry associations (7%) and federal government employees (13%). The public feedback received informed the FAR Council’s work in preparing the proposed rules. 
    • ‘While all public comments received may not be reflected, the tables below highlight examples of key policy updates that resulted from some of the public feedback submitted via acquisition.gov. The tables are organized by the RFO-related FAR rules, and will be continuously updated as the remaining RFO-related rules are published over the coming months.” 
  • Per Department of Health and Human Services news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Financial Resources (ASFR), today announced a new Department-wide policy establishing the HHS Personal Protective Equipment (PPE) Forecast. This is the first official, recurring process to identify, consolidate, and publish anticipated HHS purchases of personal protective equipment covered by the Make PPE in America Act.
    • “The new forecast will give U.S. PPE manufacturers a clearer and more predictable signal of future HHS demand. By turning the Department’s acquisition plans into actionable market visibility, the initiative will help domestic companies make better-informed decisions about hiring, production, capital investment, and manufacturing capacity while strengthening the supply chains HHS relies on during routine operations and public health emergencies.” * * *
    • American manufacturers and small businesses can review HHS procurement forecast opportunities through the HHS Small Business Customer Experience platform.
  • and

From the U.S. Office of Personnel Management front,

  • OPM Director Scott Kupor resorted to his Secrets of OPM blog [found on Substack) to ably debunk recent challenges to the cost savings created by last year’s massive reduction in federal employment.
    • “GAO estimates that agencies spent about $9.5 billion on all paid administrative leave in 2025 and attributes about $6.7 billion of that to the Deferred Resignation Program. For the sake of argument, let’s charge the entire $9.5 billion to DRP anyway. It was a one-time expense.
    • “What did the taxpayer get for it? Using rough averages, the fully loaded cost of a federal employee is about $150,000 per year. For 270,000 employees, that is more than $40 billion in annual costs. These are not one-time costs, but costs incurred every year in perpetuity.
    • “So, for a one-time expense of at most $9.5 billion, taxpayers save more than $40 billion each year. That’s a 400+% annual return, and the outlay paid for itself in under six months.”
  • Here is a link to Senator Adam Schiff’s (D CA) news release about the letter that he and fifteen other Democrat Senators sent to OPM on October 16 questioning the OPM’s use of FEHB and PSHB protected health information to help OPM’s effort to combat fraud, waste, and abuse in hose programs.
    • “We support responsible efforts to protect the integrity of federal health-benefit programs. However, OPM’s proposals create an unnecessarily broad, decades-long, re-identifiable medical history of millions of workers, retirees, spouses, children, and other family members. We strongly urge OPM to suspend further implementation while these concerns are addressed and to work with Congress, federal employees and retirees, health plans, privacy and civil-rights experts, reproductive-health advocates, and other affected stakeholders to establish safeguards commensurate with the sensitivity of the information at issue. 
    • “We request a written response and briefing by OPM on the office’s efforts related to the above requested actions no later than September 25, 2026.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
    • “The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
    • “Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.”
  • MedTech Dive relates,
    • “Cognita Imaging recently received a $1.29 million research contract from the Food and Drug Administration to test a new method of evaluating artificial intelligence-generated radiology reports. The goal is to assess whether a “jury” of large language models can evaluate another AI model’s report, and which cases need radiologist oversight.
    • “The contract, which started on June 22 and will run for 18 months, is intended to address a core problem with generative AI. Currently, most tools are evaluated against a panel of radiologist experts, but for models that can evaluate a wide variety of cases and generate different outputs, this becomes more challenging and time-consuming.”
  • STAT News tells us,
    • “In January, a paper published in Science analyzed government mortality figures, data on drugs seized by the DEA, and Reddit posts to determine that decreasing fentanyl potency due to Chinese government crackdowns could explain the recent decline in U.S. opioid overdose deaths. But when another research team tried to replicate that study, they didn’t come to the same conclusion.
    • “A simplistic supply shock is not supported by the evidence,” the authors wrote yesterday in Science Advances.
    • “The researchers noted that as fentanyl purity increased across the country, there was no associated national drop in overdose rates. While there did seem to be a broad association between declining purity and overdoses, it was shared with other, unrelated trends. And importantly, the DEA acknowledged at the time that increasing purity in its drug seizures was likely due to a change in its sampling plan.
    • “It’s also critical not to overlook geographic variability in the drug supply, the replication study authors wrote. As one of them told Lev Facher when the first study was published, many regions had declining overdose rates before potency apparently began to drop. — Theresa Gaffney

From the public health and medical /Rx research front,

  • The Centers for Disease Control and Prevention announced today
    • “As of September 18, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low overall.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 177 new cases added today, the US measles count has climbed to 3,471. * * *
    • “Today’s increase marks the sixth straight week of triple-digit increases in cases.
    • “The CDC today noted 39 outbreaks, one more than last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level in July. 
    • “The 2026 total is already 52% higher than the 2025 total, with more than three months left in the year.
    • “All but 17 of this year’s cases have been locally acquired, with the rest tied to international travel. Cases have been confirmed in 45 states plus New York City and Washington, DC.
  • The Washington Post tells us,
    • “Paul Nestadt is about as steeped in suicide prevention as a person can be.” * * *
    • “Nestadt has sought to intervene in ways that don’t require pinpointing people at risk.
    • “Chief among them: making it harder for people to carry out the act of killing themselves.
    • “Instead of asking every doctor to figure out which patient will die by suicide and locking that patient up, it might be that we need to make sure there aren’t loaded guns available,” Nestadt said.
    • “Although medication and therapy are lifesaving measures, many clinicians, researchers and people who have lost loved ones to suicide agree that more is needed. When it comes to firearms, however, broad policy approaches face major constitutional and political challenges.
    • “Research shows that limiting access to lethal means is one of the most promising approaches to save lives. It can involve erecting barriers on buildings and bridges to prevent people from jumping, as well as decreasing the number of pills someone can buy or be prescribed at once.
    • “And reducing access to guns, which are the most common and lethal method used for suicide in the United States.”
  • Beckers Behavioral Health shares summaries of “34 new behavioral health study findings to know.”
  • MedPage Today lets us know,
    • “A quarter of patients with cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD) presented before the age of 50 with distinct risk profiles, data from a prospective study showed.
    • “In models adjusting for demographic and metabolic factors, a high genetic risk score and type 2 diabetes were independently associated with early-onset MASLD cirrhosis.
    • “Reliance on age-dependent first-line liver fibrosis tools can miss cases, the researchers suggested.”
  • Per Health Day,
    • “Wearable sensors might be the key to better tracking and treating a person’s knee arthritis, a new study says.
    • “Strapped to the foot, these sensors work as well as motion capture cameras in tracking a person’s natural stride, researchers reported recently in the journal JMIR Formative Research.
    • “This stride data could be used to track how a person with knee arthritis walks, allowing doctors to track arthritis progression and potentially offer individualized therapy, researchers said.”
  • and
    • “More people are seeking emergency help for gambling problems in the face of expanded online betting markets, a new study says.
    • “ER visits for gambling disorders nearly doubled following the legalization of single-event sports betting and expansion of online gambling markets in Ontario, researchers reported Sept. 15 in the American Journal of Preventive Medicine.
    • “Most people experiencing gambling problems will never seek care, so the concern is that the increases in ED visits for gambling disorders we observed may be revealing much larger increases in gambling-related harm,” senior researcher Dr. Daniel Myran said in a news release. He’s research chair at North York General Hospital in Toronto.”
  • Per Genetic Engineering and Biotechnology News,
    • “Diabetic kidney disease is one of the most common and serious complications of diabetes, yet the chain of events linking high blood sugar to kidney damage remains incompletely understood. Now, a stem cell-based model suggests that glucose itself may help trigger an inflammatory response inside kidney tissue—one that can damage key epithelial cells.
    • “Researchers led by Benjamin S. Freedman, PhD, at the University of Washington and University of Miami, report that human kidney organoids exposed to elevated glucose developed tissue-intrinsic inflammation and epithelial cell detachment, including detachment of podocytes, specialized cells essential for the kidney’s filtration barrier. The study, “Elevated glucose in kidney organoids induces tissue-intrinsic inflammation driving epithelial detachment,” was published recently in Stem Cell Reports.
    • “High sugar causes inflammation in these organoids even though they lack an immune system,” Freedman said. “This was unexpected and gives us a new way to think about how diabetes can affect kidneys and other organs.”
  • Per Beckers Hospital Review,
    • “An investigational immunotherapy was found to almost double median overall survival in patients with previously treated squamous non-small cell lung cancer, according to new trial data.
    • “Gotistobart, developed by BioNTech and OncoC4, showed a median overall survival of 18.5 months, nearly double the 10-month median among patients who received standard of care chemotherapy, according to a Sept. 14 news release from the companies.
    • “The trial results were presented Sept. 14 at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Seoul.”

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

  • Modern Healthcare reports.
    • “Molina Healthcare is pulling its all of its Medicare plans from three states for the 2027 plan year, the company notified third-party marketers Friday.
    • “The health insurer announced in February that it would completely exit the national market for individual Medicare Advantage plans to focus on Dual Eligible Special Needs Plans, or D-SNPs, for people who qualify for both Medicare and Medicaid. The company tried to sell the individual Medicare Advantage business but failed to find a buyer.
    • “In Connecticut, Mississippi and Nevada, Molina Healthcare is going a step further by ending individual, D-SNP and other Medicare plan sales, according to the notice.”
  • Beckers Clinical Leadership relates,
    • “Two UC Health emergency departments avoided more than 3,500 unnecessary head and cervical spine CT scans over 23 months with no missed injuries identified, according to a study published in the Western Journal of Emergency Medicine.
    • “The quality improvement campaign ran at University of Cincinnati Medical Center and West Chester Hospital in West Chester Township, Ohio. The campaign paired continuing education on clinical decision rules for head and cervical spine imaging with decision-support software embedded in the EHR, plus quarterly feedback showing physicians how their own ordering compared with peers’. Teams also created patient handouts to reassure those who expected a scan they did not need.
    • “Physician-researchers estimated the effort eliminated 3,542 scans in low-risk trauma patients, avoiding $6.2 million in patient charges at roughly $1,750 per scan and saving 14,168 hours of patient waiting time. The campaign also avoided 6,021.4 millisieverts of radiation exposure — the equivalent of roughly 2,000 years of background radiation for one person.
    • “A safety review identified no patient harm and no missed injuries.” * * *
    • “View the full study here.”
  • Beckers Hospital Review tells us,
    • “Paul Krakovitz, MD, became CEO of Greensboro, N.C.-based Cone Health on March 16, roughly 15 months after the five-hospital system joined Risant Health, the nonprofit created by Oakland, Calif.-based Kaiser Permanente. Dr. Krakovitz previously held leadership roles at Cressey & Company, Intermountain Health and Cleveland Clinic.
    • “Now, Risant is involved in Cone Health’s value-based care work, bringing tools developed through Kaiser Permanente’s experience with the model to the community health system. Risant is also helping fund Cone Health’s $40 million effort to rebuild its Epic platform after years of technical debt limited the system’s ability to adopt newer capabilities.
    • “Dr. Krakovitz discussed with Becker’s the system’s work with Risant, its Epic investment and Cone Health’s efforts to move away from volume and toward more proactive care.
    • “He said Risant has brought additional resources and focus to Cone Health’s value-based care strategy while the health system remains focused on its local community.
    • “The value-based care tools that Risant brings from a national scale is just something that is incredibly unusual to be able to deploy in a community health system, and it’s a huge benefit, both for our clinicians and for our community,” Dr. Krakovitz said.”
  • Beckers Health IT adds,
    • “Techstars and the Mid-Atlantic Permanente Medical Group selected nine startups for a healthcare accelerator focused on emerging technologies and care delivery.
    • “More than 1,200 startups applied for the 2026 Techstars Healthcare Accelerator powered by Permanente Medicine Mid-Atlantic States, according to a Sept. 18 news release.
    • “The three-month program began Sept. 14 and will connect participating companies with Techstars investors and mentors as well as physicians and healthcare leaders from the Mid-Atlantic Permanente Medical Group.”
  • Beckers Hospital Review points out,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • “Here [in the article] are 60 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1, 2026.
  • Fierce Healthcare informs us,
    • “Angle Health raised $600 million in equity financing, reaching a total valuation of $2.7 billion, to continue expanding its artificial intelligence-native healthcare benefits platform for small businesses.
    • “According to the company, the financing includes a $200 million series C funding round and a $400 million tender offer. The startup’s valuation has more than doubled since its December series B round when it raised $134 million, the Wall Street Journal reported. The company raised a $58 million series A round in January 2023.
    • “Vitruvian Partners led the round, with participation from new investor Town Hall Ventures and existing investors Blumberg Capital, Portage Ventures, PruVen Capital and Y Combinator. They expect to close the round later in September.”
  • and
    • “Oura and Counsel Health are teaming up to participate in CMS’ 10-year chronic condition management program, betting that continuous health data from Oura’s smart ring paired with medical AI can help move the needle on conditions like hypertension.
    • “Counsel Health, an AI-native primary care company, plans to participate in CMS’ Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model under the early cardio-kidney-metabolic (eCKM) track, with smart ring maker Oura serving as the preferred wearable partner.
    • “It is an early example of how the CMS chronic care initiative could become a proving ground for AI-powered, wearable-enabled care delivery.”
  • and
    • “Humana researchers found that cancer patients who received specialty pharmacy care coordination services had fewer hospitalizations and emergency department visits, along with lower medical costs.
    • “The study, conducted by Humana Pharmacy Analytics and Consulting, analyzed health outcomes for people with cancer who are Humana Medicare Advantage members with Part D prescription plan coverage and who received medication adherence care coordination guidance, as compared to those who opted out of coordination. 
    • “Humana’s CenterWell Specialty Pharmacy Oncology Center of Excellence (COE) provided the care coordination services over the course of one year. That COE program provides specialized, personalized clinical care and mail-order delivery for patients managing complex cancer diagnoses and therapies. Within CenterWell, Humana’s health care services organization, CenterWell Pharmacy serves many Humana members as a mail-order pharmacy and also serves patients who are not enrolled in a Humana plan.
    • “The research was published in the Expert Review of Pharmacoeconomics & Outcomes Research.”
  • Fierce Pharma notes,
    • “As expected, the past U.S. Labor Day holiday took a toll on obesity drugs’ prescription numbers. According to IQVIA data cited by Citi, weekly scripts for Novo’s Wegovy pill dropped roughly 12% sequentially to about 161K for the last week. The decline for Foundayo was modest, at just 1%, as the Lilly drug still managed to rake in more than 47K scripts. 
    • “Lilly this week said Foundayo captured more than 30% of new patients in the U.S. market for oral obesity ​treatments, Reuters reported. 
    • “Citing Bloomberg Symphony data, Jefferies analysts suggested in a Friday note that Foundayo’s recent acceleration “has been driven primarily by retail/commercial channels.”
    • “Elsewhere, Lilly’s total Zepbound scripts were down 8.5% week over week, but the GIP/GLP-1 drug expanded its market share by 0.4% versus Novo’s Wegovy franchise, whose scripts decreased 10% during the period.”

Tuesday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion advances the Trump Administration’s Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
    • “HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
    • “Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them,” said HHS Secretary Robert F. Kennedy, Jr. “Under President Trump’s Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.”
    • “Iowa is proud to be first in the nation to adopt new peer-support interventions,” said Iowa Governor Kim Reynolds. “By responding to addiction and supporting struggling families, we’re building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.”
  • Federal News Network relates,
    • “Kevin Rhodes, the administrator of the Office of Federal Procurement Policy, is leaving federal service.
    • “A person with knowledge of the situation confirmed that Rhodes’s last day will be Sept. 4.
    • “The Senate confirmed Rhodes in October 2025, making him the first permanent OFPP administrator since 2019. He started working at OMB as a senior advisor in February 2025.
    • It’s unclear who will be acting OFPP administrator once he leaves.”
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) said Monday it “welcomes” updated guidance from the U.S. Centers for Medicare and Medicaid Services (CMS) that strengthens federal transparency requirements for prior authorization.
    • “The country’s largest physician organization had documented concerns and recommended specific corrective actions to the agency in May (PDF), following the group’s review of how 15 Medicare Advantage contracts were implementing transparency provisions of the CMS Interoperability and Prior Authorization final rule. 
    • “The 2024 final rule requires payers to publicly post prior authorization requirements and outcomes, with a three-day deadline for urgent requests and a seven-day deadline for standard requests.” * * *
    • “The updated metrics reporting framework (PDF) clarifies that posting required metrics only through password-protected portals or “other locations that cannot be reached through ordinary navigation from the payer’s public-facing website” does not satisfy the rule’s “publicly accessible” requirement.
    • “The agency now also specifies that plans must publicly identify all medical items and services requiring prior authorization and identify omission of entire categories of care from disclosures. Moreover, it clarifies disclosures must be understandable and turnaround-time metrics must include a unit of time.”
  • The American Hospital Association informs us,
    • “The Centers for Medicare & Medicaid Services yesterday announced the launch of QualTech, a new event created to identify innovative technology that improves health outcomes. CMS is seeking participants from U.S-based teams, academic institutions, nonprofit organizations, private sector companies, industry associations and other stakeholders to propose technology solutions in advance of the event. Applicants must align proposal submissions to one of four priority opportunity areas: using artificial intelligence to protect patients and strengthen healthcare quality; leveraging AI to increase annual wellness visits in Medicare; proposing a next-generation digital quality measure calculator; and supporting the development of a national quality hospital dashboard. CMS will select finalists to present at QualTech, which will be held at CMS headquarters, to CMS and Center for Clinical Standards and Quality leadership and other attendees. CMS said it may continue engagement with select organizations following the event, which could include future demonstrations, pilots, collaboration discussions and a potential role in the 2027 CMS Quality Conference. Applications must be uploaded to the QualTech submission link by Sept. 4, 2026.” 
  • Managed Healthcare Executive points out,
    • “CMS implemented MFPs for 10 high-volume Part D drugs in January 2026 after 2024 discount announcements, with projected net savings of ~$6 billion (≈22%) across those products. 
    • “Surveyed beneficiaries reported countervailing cost signals: 46% paid more for at least one negotiated drug, 39% saw premium increases, and coverage changes increased out-of-pocket exposure for 29%. 
    • “Access friction intensified, with 30% reporting 2026 barriers versus 25% in 2025, most commonly prior authorization and drug availability constraints. 
    • “Knowledge gaps were substantial, as ~40% were unaware of the $2,100 out-of-pocket cap or the Medicare Prescription Payment Plan, undermining uptake of IRA cost protections. 
    • “Payer responses appear consistent with broader market behavior, including expanded step therapy, higher premiums, and stronger generic/biosimilar preferencing, particularly affecting diabetes, dermatology, and rheumatology.”

From the U.S. Office of Personnel Management front,

  • Fedweek reports,
    • “OPM has told agencies that they “must verify 100 percent of Open Season elections in which a family member is added” in FEHB/PSHB enrollments for calendar year 2027, sending them a survey for them to verify their readiness to do so.
    • “Enrollment of ineligible persons has been a long-running issue, the subject of congressional oversight and reports from the OPM inspector general and the GAO—most recently, in a GAO report on high-priority recommendations to the agency. The cost of claims from ineligible persons is widely estimated at $1 billion a year, raising premium costs for both enrollees and the government.
    • “In a benefits administration letter dated July 15 but only recently posted, OPM noted scrutiny has been tightened in a series of administrative steps, including in a prior letter requiring at least 10 percent of new family member enrollments and recommending review of all. Language in a broader budget measure enacted last year “codifies and elevates this standard by requiring verification of family member eligibility when an enrollee adds a family member during Open Season,” it said.
  • and
    • “Recently finalized rules requiring that employee performance evaluations fit a mandated pattern will apply to the rating cycle closing next month, OPM has said, a process that will involve “calibration” by senior agency officials that potentially will reduce many of the ratings set by employees’ supervisors.
    • “While a recent memo on carrying out the changes does not specify an implementation schedule, in response to questions from FEDweek, OPM said that what it calls “standardized” rating “applies to both the FY26 and FY27 performance appraisal cycles.”
    • “Agencies must establish a calibration program for the FY26 performance appraisal closeout no later than September 20, 2026 (end of FY26 appraisal cycle). Additionally, agencies must design their new GS performance management systems, and have them approved by OPM, prior to October 1, 2026 (for FY27 implementation),” it said.
    • “Applying a standardized distribution of ratings, and designing and implementing a calibration program, is effective for the closeout of the FY26 cycle,” it said, adding that it “will be publishing FY2026 performance appraisal cycle close-out guidance separately. We expect that guidance to be released in the next few weeks.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, according to a person familiar with the matter, after a turbulent year at the agency marked by high-profile staff exits and industry complaints.
    • “Overton is a deputy assistant to the president for domestic policy at the White House working on health issues. She previously worked at the think tank America First Policy Institute. Overton is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University. She was also a White House fellow in the first Trump administration.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said comments must be submitted by Oct. 19.”  
  • MedPage Today adds,
  • Per a corporate news release,
    • “LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence.
    • “The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy.” * * *
    • “LEROCHOL autoinjector is expected to be available by January 2027 with a direct-to-patient cash price to match that of the already available pre-filled syringe at $199 per month.
  • BioPharma Dive explains that an “FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax.”
    • “Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.”

From the judicial front,

  • Beckers ASC Review reports,
    • “The American Association of Nurse Anesthesiology said July 21 that a U.S. Court of Appeals for the Sixth Circuit ruling wrongly declined to force HHS to enforce a provider nondiscrimination provision that protects certified registered nurse anesthetists from reduced insurance reimbursement.
    • “The Sixth Circuit based its ruling on associational standing, upholding a lower court’s finding that AANA lacked standing to bring the case. Mr. Molter said AANA is evaluating what the decision means for how trade associations pursue their members’ interests in federal court and is urging other associations to do the same.
    • “AANA President Jeff Molter, MSN,  MBA, CRNA, said the ruling does not endorse insurers’ practice of reimbursing CRNAs less than physician anesthesiologists for the same services. He called the decision procedural and said AANA maintains that such reduced reimbursement remains unlawful and discriminatory under current statute.”
  • The article points out nine other current anesthesia controversies.
  • Bloomberg Law relates,
    • “A federal judge in Massachusetts mostly upheld a 2025 Trump administration rule tightening oversight of Affordable Care Act exchange enrollment, adding to the legal saga dragging on over a 2026 version of the annual rule.
    • “Judge Nathaniel M. Gorton of the US District Court for the District of Massachusetts on Friday granted summary judgment for the administration in regard to provisions reducing the grace period for premium tax credit recipients to reconcile their income from two years to one year, shortening states’ open enrollment periods, increasing insurers’ flexibility to decrease the value of their plans, and changing the methodology for calculating cost-sharing amounts.
    • “But Gorton sided with the states in determining the administration did not follow the law in excluding certain “sex-trait modification procedures” from the ACA’s essential health benefits, noting that the government refused to issue a mandated report to Congress certifying that the provisions were aligned with a “typical employer plan.”
    • “When asked about the issue at oral argument, the government maintained its position that the Agency is not required to submit such a report, notwithstanding the Court’s clear ruling that it was required to do so,” he wrote in his opinion.” * * *
    • “Gorton’s opinion conflicts with the Maryland court, which rejected CMS’s ability to limit enrollment periods and increase flexibility for insurers to vary the value of their plans.
    • “CMS finalized several of the same provisions in its 2026 rule, prompting Democratic cities and states to sue again. The rule is now mostly frozen by the Maryland court.
    • “The case is California v. Kennedy , D. Mass., No. 1:25-cv-12019, opinion filed 8/14/26.”
  • The AP informs us,
    • “Luigi Mangione’s state murder trial in the killing of UnitedHealthcare CEO Brian Thompson, which was slated to begin Sept. 8, has been postponed indefinitely as his lawyers seek to have the case thrown out on double jeopardy grounds following his guilty plea last week to federal charges.
    • “Judge Gregory Carro issued an order Monday canceling the trial and giving the Manhattan District Attorney’s office, which is prosecuting the state case, until Oct. 9 to respond to the defense’s double jeopardy claims. A hearing will be held on Dec. 10, Carro said, about a week before Mangione is scheduled to be sentenced in the federal case.”

From the public health and medical / Rx research front,

  • The New York Times lets us know,
    • “What the Newest Research on Wildfire Smoke Tells Us
      • “Scientists have found that people are being exposed to more toxins than previously known.”
  • Cardiovascular Business adds,
    • “Long-term exposure to air pollution is associated with more advanced coronary atherosclerosis, including greater plaque burden and obstructive coronary artery disease, according to a large cardiac CT study published in Radiology.[1]
    • “Researchers led by Kate Hanneman, MD, MPH, associate professor and vice chair of research in the department of medical imaging at the University of Toronto, analyzed cardiac CT data from 11,128 adults who underwent clinical scans at three Toronto hospitals between 2012 and 2023. The study linked patients’ residential postal codes with air-quality data to estimate their average exposure to pollution during the 10 years before their CT examinations.
    • “What we found is that higher air pollution exposure, both gaseous and particulate, was associated with higher coronary calcium scores, higher plaque burden, and obstructive coronary disease in unadjusted models,” Hanneman explained a video interview with Cardiovascular Business at SCCT2026, the Society of Cardiovascular Computed Tomography (SCCT) annual meeting. “When we adjusted for age, sex, and traditional cardiovascular risk factors, we found that in women, higher air pollution was also associated with obstructive disease, even in these multi-variable models. So this really builds on the existing literature that tells us that higher air pollution is not good for us and it’s not good for our heart.”
  • Genetic Engineering and Biotechnology News reports,
    • “Mass General Brigham Cancer Institute researchers found that consuming one or more sugar-sweetened beverages every day was associated with an increased risk of developing gastric cancer, while artificially sweetened beverages were not associated with an increased risk. Results from the study were published in Gastro Hep Advances, in an article titled “Association between sugar-sweetened and artificially sweetened beverage intake and gastric cancer incidence.”
    • “Previous research has linked sugar-sweetened beverages with an increased risk of colorectal, breast, and liver cancers, but evidence on gastric cancer has been limited. The study analyzed data from 112,284 participants in the Nurses’ Health Study and Health Professionals Follow-Up Study. Both studies gathered detailed diet, lifestyle, and health information on U.S. adults over many decades. During the follow-up period, which spanned decades, 278 participants developed gastric cancer.
  • MedPage Today adds,
    • “A group of physicians and scientists are calling on the National Collegiate Athletic Association (NCAA) to make changes to its massive collaboration between Big 12 athletics and Monster Energy, citing potential health risks and teen deaths associated with energy-drink consumption.
    • “As part of the partnership announced last month, Big 12 football and basketball athletes will don Monster Energy-branded jerseys during the regular seasons, and the fields and courts where teams play will display the popular energy drink’s logo.
    • “Virginia-based ophthalmologist David Jacobs, MD, noticed the prominent branding of the energy drink when he went to visit his kid’s Big 12 school, and later became concerned about how the campaign could influence children.
    • “Jacobs is an alum of a Big 12 school, as is his friend, Idaho-based cardiologist Matthew Nelson, MD. The two began reaching out to other cardiologists and created the Protect Young Fansopens in a new tab or window public health initiative, which, as of press time, has gathered over 250 signatures on their petitionopens in a new tab or window asking the NCAA to end the Monster Energy partnership.
    • “We’re concerned about an increase in energy drink consumption among children and youth,” Jacobs told MedPage Today. He noted that with high-profile Big 12 sports in particular, impressionable kids will be looking up to and copying their sports idols.
    • “Their concerns are not abstract, according to an email to NCAA leadership from Jacobs, Nelson, and other physicians and scientists that was shared with MedPage Today.”
  • The American Hospital Association News relates,
    • “For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year, according to data released yesterday by the Centers for Disease Control and Prevention. Exemptions rose in 41 states and Washington, D.C. Vaccination coverage declined for all reported vaccines from the previous year. Coverage with the measles, mumps and rubella, or MMR; diphtheria, tetanus, and acellular pertussis, or DTaP; polio and varicella vaccines decreased in more than half of states. The CDC said there were approximately 280,000 kindergartners that attended school in 2025-2026 without documentation of completing the two-dose MMR vaccine.” 
  • MedPage Today adds,
    • :The hepatitis A vaccine is recommended for high-risk children and adults, while the hepatitis B vaccine is recommended for all adults under 60 years.
    • “In this study, researchers estimated that 40% of U.S. adults had immunity to hepatitis A and 27% were immune to hepatitis B virus.
    • “Levels of immunity against hepatitis A and hepatitis B viruses were “suboptimal” and persisted across high-risk groups, according to the researchers.”
  • and
    • “Despite routine rotavirus vaccination in over 140 countries, the virus still causes an estimated 25% of diarrhea deaths in children younger than 5 years.
    • “In a retrospective study of children ages 3 months to 4 years, receiving at least one dose of a rotavirus vaccine was 75.8% effective at preventing rotavirus-positive acute gastroenteritis death.
    • “Rotavirus vaccination was less effective against all-cause acute gastroenteritis mortality, at 20.8%.”
  • Beckers Clincal Leadership tells us,
    • “Blacklegged ticks carrying Lyme disease have expanded into the mountains of western North Carolina, far south of the disease’s traditional Northeast and Upper Midwest range, according to an Aug. 13 CDC report.
    • “Researchers surveilling 22 residential properties in Biltmore Forest, N.C., near Asheville, collected 373 ticks from November 2024 through August 2025, according to the CDC’s “Morbidity and Mortality Weekly Report.” Blacklegged ticks — the primary Lyme vector — made up 287, or 76.9%, of them.
    • “Nearly 40% of the adult blacklegged ticks, or 19 of 48 specimens, tested positive for Borrelia burgdorferi, the bacterium that causes Lyme disease. Three of seven nymphs also carried it.
    • “Nineteen residents across 17 households reported at least one tick-borne illness while living in the town, the CDC report said. Lyme disease was the most common, with 17 cases, followed by two cases of babesiosis and one of ehrlichiosis.
    • “The findings point to an emerging clinical blind spot. Many clinicians across the South have little experience diagnosing or managing tick-borne disease, the report’s authors said, and may not consider Lyme in patients with no travel history to endemic regions.”
  • Beckers Hospital Review informs us,
    • “Nearly every U.S. hospital screens patients for sepsis, but far fewer have dedicated personnel to ensure screening is successful, the CDC found. Moreover, separate research links a lack of specific accountability to higher mortality.
    • “In its latest annual survey of hospital sepsis programs, covering 2025, the CDC found that 93% of 5,430 hospitals have a standard process to screen for sepsis and 87% use order sets tailored to their patients. But only 36% employ a sepsis coordinator to oversee day-to-day operations, and 32% have support from staff with expertise in data, analytics and information technology.
    • “When it comes to reporting, 31% of hospitals share sepsis data with nursing, physician, unit and hospital leadership at routine intervals. At the remaining two-thirds of U.S. hospitals, that data does not reach leaders on a regular basis.
    • “Sepsis accounts for about 1.7 million adult hospitalizations per year, 350,000 of which end in death or discharge to hospice — more than a third of all hospital deaths, according to the CDC.”
  • The American Medical Association lets us know “this superbug’s toll exceeds 3,400. How to protect your loved ones.”
    • “The Candida auris fungus is spreading. Here’s what to know about the superbug, who’s most at risk, symptoms and what your next steps should be.”
  • Health Day points out,
    • “Many smokers still haven’t absorbed the fact that smoking and secondhand smoke cause heart attacks and strokes, despite decades of messaging around tobacco’s health risks, a new study says.
    • “More than 90% know that smoking causes lung cancer, but fewer know about its links to other fatal conditions, researchers report in the journal BMJ Open.
    • “Only about 80% knew smoking contributes to heart disease and heart attacks, and 70% are aware it causes strokes, researchers found.
    • “In fact, across two decades they found almost no progress in knowledge of the health risks associated with smoking.
    • “Knowledge gaps about the major health effects of smoking and secondhand smoke are deeply concerning,” said lead researcher Janet Chung-Hall, a research scientist for the International Tobacco Control Policy Evaluation Project at the University of Waterloo in Canada.”
  • and
    • “There’s been a nearly 400% increase in calls to U.S. poison centers related to liver injuries, mostly related to Tylenol and other medications, a new study says.
    • “Liver injuries caused by foreign substances skyrocketed from an estimated 11 cases per million people to nearly 53 cases per million between 2000 and 2024, researchers reported Aug. 13 in the journal Clinical Gastroenterology and Hepatology.
    • :Medications accounted for most of these liver injuries, including 85% of cases among men and 94% of cases among women, researchers found.
    • “Acetaminophen (Tylenol) was the drug most frequently implicated in liver injuries reported to poison centers, researchers said. About 33% of men and 45% of women reported injuries due solely to Tylenol.”
    • “Liver injuries reported to poison centers have increased substantially over the past 25 years, with acetaminophen emerging as a growing contributor,” researcher Dr. Christopher Holstege, director of the University of Virginia Health’s Blue Ridge Poison Center, said in a news release.”
  • Per BioPharma Dive,
    • A once high-flying Boston-area drug company mounted somewhat of a comeback Tuesday, reporting positive results from a clinical trial testing a potentially first-of-its-kind treatment for the dangerously low blood sugar levels some patients experience after bariatric surgery.
    • Amylyx Pharmaceuticals said its medicine, known as avexitide, hit the main goal of the late-stage study by spurring a 55% reduction in serious to severe hypoglycemic events compared to a placebo. Such events starve the brain of the sugar it needs for fuel, leading to confusion, dizziness, slurred speech and loss of coordination. In more dire cases, patients can faint, have seizures or become comatose.
    • “According to Amylyx, its medicine also appeared safe. Researchers classified a majority of the adverse events seen in the trial as mild or moderate, with the most common being diarrhea and bruising or redness at the injection site. Amylyx now plans to, before the end of the year, formally ask the Food and Drug Administration to approve avexitide.”

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

  • Healthcare Dive reports,
    • “CVS has added Teresa Heitsenrether, JPMorgan Chase’s chief data and analytics officer, to its board of directors as the healthcare behemoth continues to progress on its financial turnaround.
    • “Heitsenrether has spent four decades in financial services, according to Monday press release announcing her appointment. She’ll be joining CVS effective Nov. 18.
    • “CVS also said that Larry Robbins, who served on the board’s audit and public policy and external affairs committees, left earlier this month. Robbins, the CEO of Glenview Capital Management, joined the board in 2024 after the hedge fund pushed for changes at CVS.”
    • “As the leader of JPMorgan’s data and analytics, Heitsenrether sets strategy and governance standards, while driving the bank’s adoption of artificial intelligence.”
  • Beckers Payer Issues relates,
    • “UnitedHealthcare expanded its child and family behavioral coaching program, giving approximately 13 million eligible commercial members access to behavioral health support. 
    • “The 2026 expansion adds access for an additional 5 million members at no added cost for employers with fully insured plans. More than 500 employers now offer the program, according to an Aug. 18 news release from the company. 
    • “The program addresses mild to moderate anxiety, attention-deficit/hyperactivity disorder, bullying, depression and sleep difficulties, with participants being 12 years old on average. It offers up to four virtual coaching sessions per month, appointments within 48 hours, unlimited secure messaging and educational resources, and access to health and wellness coaches. Members can also be referred to licensed clinicians when higher-level care is needed.”
  • and 
    • “Blue Cross Blue Shield of Tennessee has the highest-ranked Medicare Advantage plan for member satisfaction in 2026, according to JD Power’s 12th annual Medicare Advantage study.
    • “The consumer insight firm published its annual ranking of the top MA plans in 12 markets on Aug. 18 after surveying more than 14,500 enrollees and evaluating plans on eight factors, including level of trust, ability to get health services when and how members want, helping save time or money, product and coverage offerings, ease of doing business, customer service representatives, problem resolution and digital channels.
    • “The average member satisfaction rating for MA plans this year is 611 on a 1,000-point scale, down 12 points from 2025 and down 41 points from 2024, marking a second consecutive year of decline.
    • “Satisfaction dropped across all dimensions of the member experience, with the largest two-year declines in areas tied to helping members save time and money, level of trust and whether coverage offerings met member needs. Fewer than half of plan members said they strongly agreed their plan is a trusted partner in their health and wellness. High-performing plans distinguished themselves through stronger new-member onboarding and communication, while special needs plans delivered significantly higher satisfaction and trust scores overall.”
  • Fierce Healthcare tells us,
    • “While operating margins trended upward in June, hospitals’ overall performance still lags 2025 and is seeing “intensifying” uncompensated care pressures and faster-than-inflation expense growth, according to the latest monthly benchmarks from Kaufman Hall. 
    • “The healthcare advisory firm reported a calendar year-to-date operating margin index of 2.5% and a single-month operating margin index of 4.5% (both including health system allocations for the cost of shared services). The former is a 6% lag compared to the first half of 2025, while the latter reflects a 6% bump over this May’s median operating margin.
    • “Echoing commentary from some of its preceding reports this year, Kaufman Hall’s primary red flag was a 2% month-over-month increase in daily bad debt and charity logged by hospitals, which year-to-date is 17% higher than the same cutoff in 2025. As a percentage of hospitals’ gross operating revenue, year to date, uncompensated care is 8% higher than 2025.” 
  • STAT News adds,
    • “For Bon Secours Mercy Health, Ensemble Health Partners is the gift that keeps on giving. 
    • “Seven years after the nonprofit health system sold stakes in its in-house billing and collections company to private equity investors, it still rakes in eye-popping amounts of cash from its minority position, with payments topping $1 billion so far this year.
    • “About two weeks ago, the Cincinnati-based system said it got a hefty $671 million payment from Ensemble Health Partners when the company signed a new private equity sponsor. That’s on top of a $427 million distribution Bon Secours Mercy recorded in February. Both payments were reported on the nonprofit system’s financial report for the second quarter, which ended June 30. 
    • “The $1.1 billion Bon Secours Mercy received from its 41% stake in Ensemble across the two payments far exceeds the system’s operating income in the first half of the year, which was $225 million. The health system generated $7.5 billion in revenue in the first six months of 2026, compared with $6.9 billion in the first half of 2025.” 
  • Beckers Hospital Review adds
    • “After years of high length-of-stay averages, hospitals are reporting significant length-of-stay reductions.”
      ,
  • Beckers Payer Issues notes,
    • “Montgomery, Ala.-based Jackson Hospital has filed to exit bankruptcy and signed a four-year deal with Blue Cross Blue Shield of Alabama, John Quinlivan, CEO of Jackson Hospital, said during an Aug. 17 news conference. 
    • “The BCBS agreement will become active once the exit is complete.
    • “The agreement does not give us everything we felt we needed, but combined with the continued support of Blue Cross Blue Shield of Alabama, Jackson Investment Group, the City of Montgomery, Montgomery County and the State of Alabama, it enables us to execute our strategic plan,” Mr. Quinlivan said. “We will enhance operational discipline, improve quality, expand services and add new services as we grow and innovate to better serve Montgomery and the Central Alabama region.”
  • Per Beckers Physician Leadership,
    • “Corporate entities now employ 82% of U.S. physicians, and about nine out of 10 physicians in employed settings are reporting symptoms of burnout, according to a new survey.
    • “The Physicians Advocacy Institute and Healthsperien’s Center for Health Research, Policy & Strategy surveyed more than 1,000 hospital- and corporate-employed physicians and found widespread burnout, administrative burdens and pressure to put corporate interests ahead of patient care.”
  • Per Fierce Healthcare,
    • “Four health systems are now using real-time prior authorization checks embedded in the Epic electronic health record, tackling a major pain point for providers.
    • “The electronic health record giant collaborated with insurers UnitedHealthcare, Network Health and Aetna to set up the electronic workflows to modernize the manual and time-consuming prior auth process.
    • “Epic launched real-time insurance reviews directly into EHR workflows using an industry-standard application programming interface (API) called Coverage Requirements Discovery (CRD). Epic is testing the API with 16 additional payers to support wider industry adoption, the company announced Monday as its annual Users Group Meeting kicks off in Verona, Wisconsin.”

Pre-holiday weekend report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

Note — The FEHBlog will be writing his weekly cybersecurity report tomorrow and will resume regular FEHBlog posts on Sunday July 5. Happy Independence Day! We are so blessed to be Americans.

From Washington, DC,

  • Roll Call reports,
    • “As America gets ready to celebrate its 250th birthday, Congress is taking a road trip back to the place where it all began — Independence Hall in Philadelphia. 
    • “Led by Pennsylvania Democratic Rep. Brendan F. Boyle, members will gather for a ceremonial event Thursday in his hometown, an effort Boyle said was two years in the making. 
    • “This is going to be truly one of the highlights of my tenure in Congress, to be sitting there where our Founding Fathers sat exactly 250 years prior, to the exact day,” Boyle said, adding he hoped it could be a rare “unifying moment.” 
    • “While July 4 gets most of the fanfare, Boyle said its lesser-known neighbor, July 2, deserves more attention as the day the Second Continental Congress voted to declare independence from Great Britain in 1776. 
    • “It was always the date that John Adams thought would be celebrated as America’s birthday. Unfortunately, this was another instance in which Adams lost to [Thomas] Jefferson — because Americans came to, of course, celebrate two days later the Fourth of July, which is the date Congress adopted the Declaration of Independence,” he said.” 
  • OPM Director Scott Kupor added a third post (OPM.gov link) to his Secrets of OPM blog this week. In this post, Director Kupor commemorates the new paperless federal retirement system by spurning the altar of Michael Scott, the fictious paper czar of Scranton, PA.
  • Healthcare Dive reports,
    • “The CMS proposed a rule on Thursday that would slash Medicare payment rates for a program [known as 340B] that hospitals use to buy discounted drugs and implement site-neutral payments for some imaging services next year.
    • Reforming the 340B drug discount program and better equalizing payments between sites of care have been priorities in the second Trump administration. Thursday’s proposed rule builds upon those agendas, including by expanding the services subject to site-neutral payments and more aggressively tamping down on discounts given to hospitals in the 340B drug program, which regulators previously tried to overhaul before dialing down their efforts in the face of opposition from the industry.
    • Medicare officials said the proposed rule would control costs and ensure Medicare money is directed toward “clinically appropriate” care. * * *
    • “The 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center rule proposes to increase pay for outpatient care by 2.4%, slightly less generous than the 2.6% rate update finalized last year.
    • “The rule would request information from stakeholders about how hospitals post publicly available price data, an ongoing priority for the Trump administration. Additionally, if finalized, the rule would allow certain accrediting organizations to assess hospitals on their compliance with laws regarding emergency care.”
  • The American Hospital Association News tells us,
    • “The House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions July 1 examined whether direct health care contracts between employers and providers could help address rising health care costs. During the hearing, lawmakers from both parties expressed interest in arrangements that bypass traditional insurers, with supporters citing lower costs, reduced administrative burdens and improved access to care. Witnesses highlighted advantages such as simplified billing, price transparency and direct primary care services, while lawmakers also discussed the need for greater insurer transparency and access to health plan data. The committee did not signal specific legislative proposals following the hearing.”
  • and
    • “The Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity published updated standard operating procedures for the individual access services exchange protocol and new FAQs. The revised SOP removed references to “TEFCA IAS Consent” workflows and associated patient matching methodologies, retaining the ability for providers to verify requests for access and use of data. Updates were made based on recommendations that the AHA and other stakeholders provided to SOP proposals. The SOP will be effective Aug. 3, 2026.”

No Surprises Act news

  • Federal Hearings and Appeals Services, which is certified IDR entity, tells us about
    • “The Cooling Off Period: What Providers and Health Plans Need to Know
      • “What is actually changing with the cooling off period under the final rule for the federal IDR program? To help clarify both the ongoing rules, the coming changes, and their timing, FHAS is offering two new tools to support parties.
        • “First, a new guide to the cooling off period explains which claims are subject to the cooling off period, how long it lasts, what will change under the final rule, and when those changes are coming.
        • “Second, FHAS has launched a new Cooling-Off Calculator which parties can use today to determine cooling off period dates and new dispute initiation timeframes. FHAS can help your team understand, anticipate, and implement changes directed by the final rule.”

From the judicial front,

  • Healthcare Dive reports,
    • “Elevance is suing the CMS after the agency recalculated the Medicare Advantage star ratings of a competitor in a more favorable way than it did for other plans.
    • “After losing a lawsuit earlier this year, the CMS reran 2026 quality scores for Clover Health, dropping 20 measures that a judge ruled could not be factored in. Regulators then recalculated stars for other MA insurers last month, but cut out extra measures, too — measures that Elevance performed well on, the insurer argued in its complaint filed Wednesday in Georgia district court.
    • “Elevance says it lost out on $115 million in bonus payments as a result. The company is asking the court to force CMS to redo its own ratings using the same methodology as for Clover.”
  • STAT News relates,
    • “In a victory for the pharmaceutical industry, a federal judge blocked a Colorado state panel from placing a cap on the price of a blockbuster drug sold by Amgen after deciding the company is “likely to be significantly harmed.”
    • “The ruling pauses a controversial, first-in-the-nation move by the Colorado Prescription Drug Affordability Board, which was created four years ago in response to the rising cost of prescription medicines and is permitted to set upper payment limits on what most state residents will pay for selected drugs.” * * *
    • “Last October, the board then voted to limit what health plans in the state will pay for the drug. The board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $30,350 a year per person, effective on January 1, 2027. That compared with roughly $53,000 that the average plan in the state paid in 2023, according to a state claims database.
    • “The drugmaker then quickly filed a second lawsuit, reiterating its earlier arguments. Meanwhile, the company had until July 5 to decide whether to continue selling the treatment, which has a list price exceeding $100,000 a year and generated $2.23 billion in sales last year, in Colorado.
    • “But Judge Daniel Domenico of the U.S. District Court in Denver agreed with the company. In his ruling, which was issued on Wednesday, he noted that the state has a ​legitimate interest in helping patients afford Enbrel, but “capping the price of a patented drug” is not an ​option.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The U.S. overall death rate in 2025 fell to its lowest point on record, even as influenza and pneumonia are now among the nation’s top 10 causes of death for the first time in years, according to new data from the Centers for Disease Control and Prevention.
    • “The death rate fell 4.6% last year, to 689.2 deaths per 100,000 people, down from 722.1 in 2024, according to the CDC’s National Center for Health Statistics. The death rate declined across every age group and nearly every demographic group tracked in the provisional report.
    • “The main driver of the record low was a continued drop in drug overdose deaths, said Farida Ahmad, a health scientist at the CDC and one of the report’s co-authors. Another factor, she added, was that Covid-19 no longer contributed to as many deaths.
    • “Against that backdrop, influenza and pneumonia stood out—moving from 11th to eighth place in all age groups—with 56,511 deaths in 2025 compared with 48,139 in 2024. It is the first time the influenza category has cracked the top 10 since 2020.”
  • AAMC relates,
    • “Patients arrive in the emergency department (ED) doubled over in pain and retching uncontrollably, a brew of symptoms physicians have nicknamed “scromiting” — a combination of screaming and vomiting. The problem: an underrecognized consequence of cannabis use called cannabinoid hyperemesis syndrome (CHS), and emergency medicine physicians say few conditions leave patients more obviously miserable.
    • “My heart breaks for them,” says Kathleen Clem, MD, an emergency medicine physician at Dartmouth Health in Lebanon, New Hampshire, and interim associate dean for faculty affairs at the Geisel School of Medicine at Dartmouth. “They come in because they absolutely cannot keep anything down. They’re dehydrated and their belly is sore from vomiting so much. Sometimes they vomit so much, they’ll break little blood vessels in their esophagus, and little bits of blood come up with that.”
    • “The leading cause of marijuana-related ED visits, CHS is associated with the chronic and long-term use of marijuana products, and it is becoming more prevalent, likely due to the increased legalization of marijuana. Some 24 states have legalized recreational marijuana use since 2012, and 40 states allow its use as a medicinal treatment. An additional eight states allow “limited-access” medical cannabis, which refers to low-THC (tetrahydrocannabinol) products and CBD (cannabinoid) oil.
    • “In the United States, cannabis use has nearly doubled in the past decade, with 22.3% of individuals 12 years and older — 64.2 million people — reporting its use in the past year, up from 12.6% in 2013, according to data from the Substance Abuse and Mental Health Services Administration. And research shows a 15-fold increase in the number of people reporting daily or near daily cannabis use from 1992 to 2022.”
  • The Today Show adds,
    • “Cyclosporiasis, a nasty parasitic infection that causes “explosive” watery diarrhea, has sickened dozens of people in Michigan and other parts of the United States.
    • “Cases of the gastrointestinal illness, caused by a parasite that spreads through contaminated food, have been on the rise in multiple states since May, according to the U.S. Centers for Disease Control and Prevention. At least 20 people have been hospitalized nationwide so far. 
    • “The CDC is working to identify potential sources of the parasitic infection, which is commonly linked to fresh produce.” * * *
    • “The U.S. typically sees several hundred cases of cyclosporiasis annually. In recent years, the number of infections reported in the U.S. has increased significantly.” * * *
    • “The best way to prevent infection is to avoid consuming food or water that may be contaminated with feces, the CDC says. Following proper hand hygiene and safe food handling practices can also lower your risk of foodborne illness.”
  • The New York Times points out,
    • Habitual users of fentanyl have developed such a strong tolerance to the drug that standard doses of medications to manage withdrawal and initiate recovery are no longer working for many patients, a team of researchers in Los Angeles has found.
    • Their study, published in the journal Drug and Alcohol Dependence, presents a picture of the dangerous volatility of the city’s street supply and the capacity of users to tolerate ever greater amounts of pure fentanyl, which is at least 50 times more potent than heroin.
    • “In a summary of the findings, Morgan Godvin, one of the lead authors of the study and a health services researcher at the University of California, Los Angeles, said that a seasoned user’s daily street dose of fentanyl was roughly equivalent to 1,250 hospital doses of 100 micrograms of fentanyl given during and after surgery.
    • “In any other context, that would be unsurvivable,” she wrote. “Among people who use fentanyl every day, it is routine.”
    • “The study reinforces the belief among many addiction experts that, for high-tolerance patients, the standard treatment regimens for opioid addiction have become outdated. Doses of medications such as buprenorphine and methadone, opioids that help satisfy cravings without inducing a high, were calculated to treat addictions to heroin and prescription painkillers. The results of the new research, experts said, support a growing call by clinicians for treatment guidelines to be revised to keep pace with the convulsive drug market.”
  • MedPage Today tells us,
    • “A global study showed that body mass index-associated gaps in blood pressure and cholesterol have diminished from 1990 to 2024.
    • “With more medications being used, older people with obesity were metabolically similar to, and in some countries even lower risk than, people with a normal BMI.
    • “Young adults with obesity remain metabolically higher risk, however, and should be a focus of prevention and treatment, some say.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For nearly half a century, scientists have known that malaria parasites force their way into human red blood cells (RBCs) through a ring-shaped structure called the moving junction (MJ). What no one could work out was what it actually does. The structure assembles, does its job, and dissipates in the space of 60 seconds—gone before anyone can get a close look.
    • “A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.
    • “The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.”
  • The Washington Post lets us know,
    • “When it comes to dementia risk, certain factors, such as genetics, are out of your control. However, plenty of research suggests lifestyle behaviors— things you can change — may help improve your chances of staying sharp as you age. In a new study, people with an elevated risk of dementia were less likely to develop the condition if they followed a healthy dietary pattern, particularly a less inflammatory one.”
  • Per BioPharma Dive,
    • “Roche’s experimental medicine divarasib helped patients with a certain type of lung cancer live longer than two approved treatments in a new study.
    • “The Phase 3 trial compared divarasib with Amgen’s Lumakra and Bristol Myers Squibb’s Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday.
    • “Roche did not release detailed data, saying the results would be presented at an upcoming medical meeting. There were no new safety findings of concern and most treatment-related side effects were “manageable and reversible,” the company said.”

From the U.S. healthcare business front,

  • Healthexec reports,
    • With Election Day only four months away, healthcare is again emerging as a major source of idealistic campaign promises. Many of these are driven by widespread public angst. What sorts of changes can U.S. healthcare stakeholders realistically expect once the results are in? 
    • “Professional prognosticators at the global accounting and consulting firm PricewaterhouseCoopers, aka PwC, have considered the policy possibilities and are sharing their thinking in writing. * * * PwC offers forward-looking insights and advice for organizations across healthcare’s four major subsectors. 
      • “PROVIDERS: Policy drivers are reshaping delivery and access. 
        Healthcare providers will do well to “examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain,” PwC comments. 
        ‘This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.’
      • “PAYERS: Policy drivers are reshaping cost structures. 
        “Healthcare payers will likely need to strengthen care management capabilities as they expand their holistic support to members, the analysts forecast. 
        ‘This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans.’
      • “PHARMA: Policy drivers are reshaping pipeline decisions, regulatory strategy and market access. 
        “In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, “should expand from drug manufacturers to ‘lifespan partners,’ requiring more agile operating models and greater collaboration across technology, and ecosystem players,” the authors write.  
        ‘In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.’
      • “MEDTECH: Policy drivers are reducing federal oversight of AI-powered and wellness devices. 
        “Going forward, the subsector is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home, PwC remarks. 
        ‘MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.’
  • Cardiovascular News relates,
    • “The American College of Cardiology (ACC) reached a major milestone this summer; its highest honor, the HeartCARE Center National Distinction of Excellence, has officially been awarded to 100 U.S. hospitals [all of which are listed in the article]. 
    • “The ACC established the HeartCARE Center designation in 2018 to celebrate hospitals and health systems that “demonstrate ongoing excellence through comprehensive accreditation, data-driven performance measurement and continuous quality improvement initiatives.” Recipients must be “forward-thinking organizations” that participate in ACC Accreditation Services programs, NCDR registries and other quality improvement campaigns focused on cardiovascular health.
    • “Reaching 100 hospitals recognized as ACC HeartCARE Centers marks an important milestone in our ongoing effort to elevate the standard of cardiovascular care,” Steven B. Deitelzweig, MD, chair of the ACC Accreditation Oversight Committee, said in a statement. “Each of these institutions has demonstrated a deep commitment to evidence-based care, continuous quality improvement and measurable outcomes—ensuring that patients receive the highest level of cardiovascular care, no matter where they live.”
  • Beckers Hospital News tells us,
    • “The Kroger Co. will acquire supermarket chain Giant Eagle, Inc. for $1.65 billion, expanding its pharmacy footprint across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.
    • “Giant Eagle operates 11 standalone pharmacies, according to a July 1 news release. Kroger said the acquisition will strengthen its presence in adjacent markets and build on Giant Eagle’s pharmacy business, loyalty program and private label portfolio. 
    • “The deal adds to Kroger’s pharmacy footprint at a time when retail pharmacy access is contracting elsewhere in the industry, with Walgreens restructuring into five standalone companies following multibillion-dollar operating losses and Rite Aid’s footprint largely gone — a gap health systems have increasingly stepped in to fill by opening their own pharmacies.” 
  • MedTech Dive informs us,
    • “Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
    • “The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
    • “Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.”

Monday report

David Ermer–Agentic & Generative AI, CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The solstice this weekend marked the start of astronomical summer — and in Washington, D.C., that means the legislative clock is ticking.
    • “Lawmakers are eager to head home and campaign on a housing bill that’s nearing passage, but progress on several other issues has stalled, and it’s unclear whether a visit from President Donald Trump will break the logjam or cause further obstruction.”
  • Congress.gov finally has updated this week’s Committee hearings list. No hearings were held today. Of note,
    • Senate Committee on Homeland Security and Governmental Affairs
    • Wednesday, June 24, 2026
    • 9:30 AM (EDT) – Senate | 342 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine reforming the U.S. Postal Service’s business model.
    • Meeting Details
  • Federal News Network tells us,
    • “The Federal Regulatory Council is giving the federal community one more chance to speak up before the first set of major revisions to acquisition regulations becomes final.
    • “In Tuesday’s Federal Register, the FAR Council will release the first tranche of proposed rules for 17 sections of the FAR.
    • “Industry and government have largely seen these changes in the deviations, but there are additional differences or changes from what we have in deviations,” said an OMB official, who requested anonymity in order to discuss the proposed rules. “The general premise for each of the rules should already be familiar to most people. This is now to tell us where we missed something or how to refine a particular area.”
  • Kevin Moss, writing in Federal News Network, points out,
    • “Benjamin Franklin famously wrote, “In this world nothing can be said to be certain, except death and taxes.” If Flexible Spending Accounts had existed in his time, he might have added one more certainty: If you use an FSA, you’ll save money on your healthcare expenses.
    • “Yet despite rising healthcare costs and tighter budgets, most federal employees are leaving this guaranteed savings opportunity on the table. In fact, only one in five participate in the FSA program, meaning most employees are paying more than they need to.
    • “The good news? FSAs aren’t complicated, and you don’t have to be a benefits expert to take advantage of them.
    • “In this article, we’ll break down how they work, share a simple strategy to help you use one successfully (even if it’s your first time), and show why this is one of the easiest ways federal employees can immediately reduce their out-of-pocket healthcare costs.”
  • The FEHBlog heartily agrees with Mr. Moss.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort [PDF, 2.10 MB]* to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
    • “For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet in recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.”
  • Beckers Payer Issues relates,
    • “Earlier in June, the HHS Office of Inspector General published two reports shedding light on post-acute care denials and overturned appeals from Medicare Advantage organizations. AHIP is pushing back.
    • “The reports ignore serious, well-documented concerns about wide variations in the cost and quality of post-acute care and skilled nursing facilities. More than 35 million Americans actively choose MA because it provides them with better, more affordable care — including helping seniors transition to high-quality, clinically appropriate care settings to support their rehab and recovery,” an AHIP spokesperson said in a June 11 statement.
    • “AHIP cited previous OIG research from 2018 that raised concerns about spending and quality with post-acute care. Based on a sample, OIG estimated Medicare paid inpatient rehabilitation facilities across the country $5.7 billion for unnecessary or unreasonable beneficiary care. The news release also featured Stanford (Calif.) University research from 2022 on risks of skilled nursing facility overuse based on Medicare’s reimbursement approach.
    • “AHIP also pointed to a lack of context in the OIG reports. Administrative issues — including out-of-network providers, services excluded from coverage and missing documentation — could all contribute to denials, not just denials that did not meet medical necessity standards. AHIP said reports also excluded common rationales for overturned denials, such as providers’ offices adding information that was initially missing from a claim.
    • “When combined with timely clinical information from our provider partners, prior authorization supports safe, effective and affordable care,” a CVS spokesperson previously told Becker’s. “We review requests promptly, offer a clear appeals process and are leading the way for continuous patient-centered improvements.”
    • “AHIP commissioned insights from analytics firm Inovalon, finding that, compared to fee for service, MA patients had 30% fewer inpatient days and 71% fewer preventable hospitalizations.”

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration June 22 announced multiple actions to help accelerate early- and late-stage drug development. The actions are part of a larger Department of Health and Human Services initiative announced June 22 on clinical research efforts, called Operation TrailBlazer. The FDA’s efforts include a request for information on a new drug pilot program that would shorten the period from drug identification to first-in-human studies and protect clinical trial participants. The program would create a network of qualified research institutions, including academic medical centers, healthcare networks, contract research organizations, regulatory advisors and other research organizations, to partner with sponsors and develop and review protocols for first-in-human clinical trials intended for new drug submissions to the FDA.” 
  • The Wall Street Journal relates,
    • “The Food and Drug Administration has agreed to reverse its rejection of Regenxbio’s RGNX experimental gene therapy for a rare and fatal brain disease, the company said, the latest about-face by the agency under new leadership.
    • “The FDA didn’t respond to requests for comment.” * * *
    • “Regenxbio’s Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient’s midteens. 
    • “The disease affects about 2,000 people worldwide—nearly all boys—and about 50 people are diagnosed a year in the U.S.
    • “Navsunli promises to replace a defective gene, allowing boys who take the drug to start producing a protein that prevents the buildup of harmful substances in the brain and tissues.”
  • MedTech Dive tells us,
    • “Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
    • “The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
    • “Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.”
  • and
    • “Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. 
    • “The warning letter focused on MRI compatibility problems with some of Zoll’s portable ventilators. It also cited concerns with automated external defibrillators and electrodes used with the company’s defibrillators.
    • “Zoll, a subsidiary of Asahi Kasei that makes ventilators, defibrillators and other medical devices, received the warning letter on April 30, and the FDA posted the letter on Tuesday. The warning followed an inspection of Zoll’s facility in Chelmsford, Massachusetts, where the company is headquartered, between February and April 2025. 
    • “The FDA uses warning letters to flag significant violations after an inspection.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Utah has spent the past year fighting measles outbreaks — a grim milestone that could affect whether the United States can keep its measles-free designation. 
    • “More than 680 people have gotten sick since the state’s first outbreak began on June 20, 2025.
    • “Unlike measles outbreaks in Texas, South Carolina and Arizona, the spread in Utah has been tough to contain to one region — infecting undervaccinated communities in nearly every county. 
    • “Measles popped up in healthcare settings, big-box stores and restaurants, and youth sporting events. In February, an exposure at a state high school wrestling championship sparked at least 46 cases among attendees.” * * *
    • “More than 16% of the region’s kindergarteners were missing their measles vaccines in the last school year, according to state data. Statewide, 12.8% were missing their vaccine, putting the state far short of the 95% vaccination rate needed to prevent measles outbreaks.”
  • The American Medical Association lets us know what doctors want their patient to know about rib injuries.
    • “Rib injuries can range from bruises and stress injuries to fractures with overlapping symptoms.”
  • The Wall Street Journal tells us,
    • “Elementary school-age children are receiving GLP-1 weight-loss drugs such as Wegovy, despite that the medications aren’t being approved for obesity in this age group.
    • “Doctors prescribing GLP-1s to young children cite the severity of childhood obesity and its complications, seeing significant BMI decreases in some patients.
    • “Some doctors express concern about potential long-term effects on bone growth and brain development, while a guideline recommends medication only for children 12 and older.”
  • MedPage Today informs us,
    • “Adults ages 80 and older with unusually fast gait had about half the cognitive impairment risk as others, data from several studies suggested.
    • “Earlier research showed that super movers — people 80 and older who walk as fast as people 30 years younger — had a lower burden of disease, a healthier lifestyle, and a younger biological age.
    • “Findings suggested that mobility may reflect broad resilience across brain, cardiovascular, and muscle systems.”
  • and
    • “Previous research showed that combining the multicomponent blood-based biomarker Stockholm3 test with an MRI-targeted biopsy approach decreased overdetection of prostate cancers, while still detecting clinically significant cancers.
    • “In this analysis, the Stockholm3 test identified more clinically significant prostate cancers, while missing fewer cases, compared with standard PSA screening.
    • “These results support the use of the Stockholm3 test in the context of a risk-adapted screening approach, researchers said.”
  • and
    • “A major health system tested one multilevel approach to antithrombotic stewardship in the face of antiplatelet overprescribing among [direct oral anticoagulants] DOAC users.
    • “Antiplatelet use dropped following an initial educational outreach and a subsequent clinical pharmacist-facing electronic flag within a DOAC population management tool.
    • “The greatest benefit was observed in patients with stable [cornary artery disease] CAD, a group appropriate for antiplatelet deimplementation.”
  • STAT News notes,
    • “Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial.
    • “Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the upcoming data readout a “major oncology catalyst” and said he had spoken to a doctor who was “optimistic” about its potential.” * * *
    • “The drug is an antibody-drug conjugate targeting integrin beta-6, a protein that is involved in tissue repair and is undetectable in normal cells but upregulated in cancer cells and is expressed in 90% of non-small cell lung cancer tumors. Pfizer was studying it compared to docetaxel in patients with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer.
    • “But the drug did not result in a statistically significant improvement in overall survival over docetaxel. This was the study’s main goal, which means researchers will likely view other potentially encouraging conclusions from the clinical trial as requiring further proof.”

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

  • The Wall Street Journal reports,
    • “AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion to bolster its core immunology franchise.
    • “The deal includes Apogee’s experimental drug zumilokibart, a potential rival to Dupixent for moderate to severe atopic dermatitis.
    • “The acquisition, expected to close in the third quarter, will cut adjusted per-share earnings by 46 cents in 2027.”
  • STAT News adds,
    • “Pharma goes on a spending spree, snapping up biotechs in a hurry.
      • “M&A activity [like the AbbVie deal] has soared in the first half of the year.” * * *
      • “The amount of money put toward M&A in the first three months of 2026 was the highest seen since 2020, according to a report from PwC. 
      • “The flurry of M&A is also a welcome reprieve for biotech startup executives, who have struggled to finance their drug trials or early lab research, as well as venture capitalists searching for investment returns. It’s provided a lifeline to some biotech startups struggling to stay afloat.” 
  • Modern Healthcare relates,
    • “As the federal government expands access to weight-loss drugs for Medicare patients, Walmart and its Sam’s Club subsidiary are ramping up support services for beneficiaries who may be seeking the medications. 
    • “The Medicare GLP-1 Bridge program, which the Centers for Medicare and Medicaid Services is launching July 1, will allow eligible Part D beneficiaries access to certain GLP-1 drugs often used for weight management. 
    • “The retailers noted in a Monday news release Medicare patients may face hurdles understanding eligibility requirements, prescription coverage processes, provider documentation needs and pharmacy fulfillment options.
    • “The initiative, also launching July 1, will offer educational materials, consultations with pharmacists, assistance navigating government and healthcare resources, increased in-store support, digital health tools and connection to additional health services like vision care. 
    • “The retailer said in the release it is not responsible for eligibility determinations, coverage decisions and treatment recommendations.”
  • Beckers Hospital Review adds,
    • “CVS Health is expanding support services for patients using GLP-1 medications, including a new $50 monthly copay option for eligible Medicare beneficiaries and a $49 virtual weight management visit through MinuteClinic.
    • “CVS Pharmacy will begin participating in the CMS’ Medicare GLP-1 Bridge program July 1, according to a June 22 company news release. Established under agreements the Trump administration negotiated with Eli Lilly and Novo Nordisk in November, the program will set a $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound, with patients paying $50 per month out of pocket. 
    • “The company also launched a new MinuteClinic virtual care offering available in 47 states and Washington, D.C. The service connects eligible adults ages 18-64 with licensed clinicians who can evaluate patients for weight loss treatment and, when clinically appropriate, prescribe FDA-approved GLP-1 medications. Visits cost $49 and do not require a recurring membership fee.
    • “CVS said the initiative also includes expanded pharmacist support and over-the-counter products designed to help patients manage common GLP-1 side effects and remain on therapy. The company plans to offer dedicated product displays in select stores focused on nausea, gastrointestinal discomfort, hydration and nutrition support.”
  • HR Dive notes,
    • “SHRM members are shaking up their prescription drug benefits strategies thanks to cost increases that are driven in part by a massive uptake of weight loss medications, analysts for the HR organization said during its 2026 annual conference on Tuesday.
    • “Specifically, GLP-1 drugs have become a “massive line item” for employers, said Kathryn Mayer, senior specialist, content at SHRM. The organization’s 2026 Employee Benefits Survey found that while close to half of the roughly 5,500 employer respondents covered GLP-1s for Type 2 diabetes management, only 15% did so for weight management.
    • “We’re finding that employers are struggling to fund GLPs,” said Calven Engstrom, a SHRM senior researcher. But given strong evidence of the drugs’ effectiveness and high demand from employees — a 2025 KFF poll found that 1 in 8 U.S. adults said they were currently taking a GLP-1 drug— organizations have to weigh competing interests.
    • “Many of these organizations are trying to balance employee health outcomes with the long-term affordability and sustainability of their typical health plan,” Engstrom said, adding that utilization rates for GLP-1s are probably among the most closely monitored by employers at the moment.”
  • Per a Fair Health news release,
    • “The national median total cost for a C-section for commercially insured patients staying in network is $19,911, and for vaginal delivery it is $15,728, according to FAIR Health’s Cost of Giving Birth Tracker. These figures reflect the national median allowed (in-network) amount for the procedures. 
    • ‘The Cost of Giving Birth Tracker is a free, interactive tool, updated today, that tracks the cost of giving birth state by state. Available on FAIR Health’s website fairhealth.org, the Cost of Giving Birth Tracker consists of heat maps that show state-specific and national median charge and allowed amounts for vaginal deliveries and C-sections. The tool draws on the national, independent nonprofit FAIR Health’s database of commercial healthcare claim records—the nation’s largest such repository, which is growing at a rate of more than four billion claim records a year.
    • “The Cost of Giving Birth Tracker includes inpatient and outpatient facility and professional costs. Services include the delivery itself (e.g., pharmacy, nursery, labor and delivery room, medical and surgical supplies, room and board for the mother), anesthesia, fetal nonstress tests, ultrasounds, laboratory work and a breast pump. The data come from the September 2025 release of the vaginal delivery and C-section FH® Total Treatment Cost benchmarks.”
  • Modern Healthcare informs us,
    • “Health systems are investing in remote patient monitoring despite reimbursement rates that often don’t cover technology and staffing costs.
    • “Providers are banking on remote monitoring programs’ long-term, less easily quantified benefits.
    • “Stanford Health Care, UMass Memorial Health, OSF HealthCare and others are using technology to keep an eye on patients outside hospital walls.”
  • Fierce Healthcare notes,
    • “Online portal messages sent to providers more than doubled between 2020 and 2025 as patients now have much more direct access to physicians. But there hasn’t been a corresponding drop-off in clinic visits as digital medicine is adding to clinicians’ workload rather than replacing in-person care, a new study finds.
    • “At least 12% of Americans now communicate with their healthcare providers about appointments, test results and ongoing treatments via secure online patient portals and health apps, according to a study led by researchers at NYU Langone Health and published today in the Journal of the American Medical Association (JAMA) online.
    • “Online portal messages jumped 153% from 2020 to 2025, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025. But these digital messages are not replacing in-office visits, which have returned to an average of between two and three per year per patient. In-person office visits saw a modest 17% increase, going from 2.37 to 2.77 per patient per year, during the study period.
    • “By contrast, total telephone calls decreased by 6% over the same period.”
  • and
    • “Nine months after announcing its seed funding round, Prosper AI banked $30 million to scale its agentic AI platform to power administrative tasks from patient scheduling to insurance verification and patient billing.
    • “While many voice AI companies focus on specific tasks, like patient scheduling or billing, Prosper AI was designed to manage the broader patient journey, according to executives. The platform answers patient calls, schedules appointments directly in the electronic health record, verifies insurance benefits, automates patient billing and contacts insurers on the phone when additional information is needed. 
    • “Prosper AI’s ambition is to build an AI workforce for healthcare operations teams, Xavier de Gracia, the startup’s co-founder and co-CEO, told Fierce Healthcare. Prosper AI first shared the funding news with Fierce Healthcare.
    • “We believe that three to five years from now, larger patient groups and health systems are going to have a layer of workforce that’s going to be AI, not only humans, and it’s going to complement the work that humans are doing, and we believe that EHRs are going to partner and are already partnering to build a layer on top of the electronic health record. Our vision is to be completely agentic.” 

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Federal News Network reports,
    • “Following more than a year of sweeping reductions across the federal workforce, Office of Personnel Management Director Scott Kupor told House lawmakers on Wednesday that he would be open to hiring more federal employees — with one crucial caveat.
    • “Kupor said he would be “perfectly happy” to see an increase in federal workforce staffing if it meant that the number of federal contractors went down. The OPM director described contractors as a “shadow” workforce and argued that creating that type of shift would save taxpayer costs and improve government services.
    • “Contractors, I think, can be very valuable where you have temporary assignments, or you have skill gaps where potentially the government can’t recruit those,” Kupor told the House Appropriations Committee’s subcommittee on financial services and general government. “Instead, we have people who are contractors for five, 10, 15, 20 years. They are basically full-time employees in disguise, and they get paid anywhere from 25% to 100% higher than what a federal employee would.”
  • Payment accuracy.gov commends OPM for being one of the three highest performing agencies. OPM’s annual agency financial report for FY 2025 (p. 112) adds the following detail
    • “In FY 2025, FEHB ERC [experience rated carriers, which includes all nationwide plans] activity is reporting a statistically valid improper and unknown payment estimated amount and rate. The ERC activity reports one year in arrears, based on the time necessary to collect, test, report and aggregate the data. Because the ERC activity reports in arrears, PSHB data is not included in the IP estimate being reported in 2025.
    • “Independent public accountants (IPAs) provide the data by conducting sampling, testing and reporting of transactions performed by carriers as required in the Financial Reporting and Audit Guide’s Agreed Upon Procedures.” * * *
    • Based on the results of the sampling and testing for 2024, the FEHB ERCs properly paid 99.86 percent of payments. The FEHB ERCs had an improper and unknown payment rate of 0.14 percent.
  • That information shows that carriers have strong controls over benefit payments.
  • The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20. 
  • The Wall Street Journal points out,
    • “Indiana is barring Piece by Piece Autism Centers from billing its Medicaid program after a Journal article detailed the company’s practices.
    • “Piece by Piece received the highest per-patient payments in 2023, averaging $340,000, in part by raising list prices up to $640 an hour.
    • “Indiana’s Medicaid director, Mitch Roob, issued an ultimatum to providers to self-report abuses by April 3 or face federal scrutiny.”
  • Modern Healthcare relates,
    • “The Republican congressional majority is weighing further cuts to health programs a year after taking $1 trillion out of the system.
    • “The GOP would use an expedited process called budget reconciliation to prevent Senate Democratic filibusters.
    • ‘The measure could be a vehicle for cuts that didn’t make it into last year’s tax law and for President Donald Trump’s health proposals.
    • “Trump’s demands for Iran war funding and voting restrictions provide the GOP with an opportunity to advance more spending cuts.”
  • Federal News Network further notes,
    • “The U.S. Postal Service is adding a temporary surcharge to most of its standard package shipping options, citing higher fuel and transportation costs.
    • “USPS told its regulatory agency on Wednesday that it plans to implement an 8% across-the-board increase in prices for its core package and shipping services on April 26, and would remain in place until Jan. 17, 2027.
    • “At that time, the Postal Service can determine if a different long-term approach is needed,” USPS said in a press release.
    • “Previously, USPS has only sought limited-time price increases on its package services during its busy holiday peak season, which runs from October through December. But agency officials told the Postal Regulatory Commission that this surcharge is now necessary to account for the higher cost of fuel and contracted transportation services.”
  • Beckers Hospital Review tells us,
    • “The White House has delayed nominating a new CDC director, allowing Jay Bhattacharya, MD, director of the National Institutes of Health, to continue leading the agency past the March 26 deadline, The Washington Post reported March 25.
    • “Dr. Bhattacharya has served as acting CDC director since Feb. 18. Although he will no longer hold that title due to federal rules, he will retain authority over the agency’s delegable duties, an HHS spokesperson told the Post.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20.” 
  • Fierce Pharma relates,
    • “The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates.
    • “In approving Denali’s tividenofusp alfa, now known as Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that can address the condition’s pernicious cognitive symptoms. 
    • “Avlayah is the first product approved to address neurologic complications of Hunter syndrome,” Tracy Beth Høeg, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a March 25 release. “This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah’s clinical benefit.”
  • and
    • “With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year. 
    • “The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin). 
    • “The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.” “

From the public health and medical / Rx research front,

  • Infectious Disease Advisor relates,
    • “The high rate of persistent physical and psychosocial sequelae of mpox suggests clinicians should consider screening affected individuals for symptoms of depression as well as social and occupational disruptions following acute illness.”
  • Health Day adds,
    • “New fathers might be proud poppas, but their mental health might be shaky as they adapt to their increased responsibilities, a new study says.
    • “Men have a 30% increased risk of depression and stress disorders by the end of their first year of fatherhood, researchers reported March 23 in JAMA Network Open.
    • “This follows a mental health boost among men during pregnancy and the first few months following birth, researchers found.”
  • Healio tells us,
    • “Limiting sedentary time and increasing light-intensity physical activity may reduce risk for developing a hypertensive disorder of pregnancy, according to study findings.
    • “Clinicians should consider counseling pregnant patients not only about exercise, but also about their everyday movement patterns. Based on our findings, limiting sedentary time to no more than 10 hours per day, and ideally closer to 8 hours, may help reduce the risk of developing a hypertensive disorder of pregnancy. Encouraging frequent light-intensity movement throughout the day appears to be an important and achievable target for improving pregnancy health,” Kara M. Whitaker, PhD, MPH, FAHA, associate professor in the department of health, sport and human physiology at University of Iowa, told Healio.”
  • Pharmacy Time adds,
    • “Compositional modeling of sedentary time, light activity, moderate-to-vigorous physical activity (MVPA), and sleep quantified insulin-resistance impacts of time reallocation while adjusting for sociodemographic and seasonal covariates. 
    • “Replacing 30 sedentary minutes with MVPA correlated with approximately 15% lower the homeostatic model assessment of insulin resistance, a clinically meaningful shift in a validated proxy for type 2 diabetes risk. 
    • “Shifting sedentary time to sleep also improved insulin resistance, supporting sleep duration as a metabolic cotarget alongside physical activity in adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck MRK has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals TERN and its promising leukemia treatment.
    • If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection [in 2028].
    • Under the terms, Merck would pay $53 a share for Terns, Merck said Wednesday. The deal is worth $5.7 billion including the cash that Terns has on hand.” * * *
    • “Merck said it expects the deal to close by the end of June and result in a second-quarter charge of about $5.8 billion, or about $2.35 a share.”
  • MedTech Dive relates,
    • “Thermo Fisher Scientific said Tuesday that it has closed the $8.9 billion takeover of Clario, expanding its capabilities for handling clinical trial endpoint data.
    • “The buyout, which was announced in October, gives Thermo Fisher a platform for capturing and managing safety data, efficacy results and patient-reported outcomes in clinical trials.
    • “Thermo Fisher will integrate Clario’s platform with its existing capabilities for analyzing biological samples to create a high-growth business, CEO Marc Casper said at a recent investor event.”
  • BioPharma Dive informs us,
    • “Sarepta Therapeutics shares jumped 25% Wednesday morning after the company unveiled promising early clinical data for two medicines that it gained rights to through a deal with Arrowhead Pharmaceuticals worth more than $1 billion.
    • “The experimental drugs, dubbed SRP-1001 and SRP-1003, aim to treat two rare, genetic conditions that cause dangerous muscle deterioration. The therapies work by delivering small interfering strands of RNA, or siRNA, into muscle tissue to target the genetic abnormalities.
    • “Results from two Phase 1/2 studies released Wednesday show both medicines achieved high muscle concentrations without severe side effects, according to Sarepta. The company said it also has proof-of-concept data showing these treatments can hit their genetic targets.”

Tuesday report

David Ermer–CDC, Congress, FDA, Government Contracting, Medical / Rx research, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • STAT News reports,
    • “President Donald Trump said Tuesday he wants Republicans to reach a deal on health care insurance assistance by being willing to bend on a 50-year-old budget policy that bars federal money from being spent on abortion services.
    • “You have to be a little flexible” on the Hyde Amendment, Trump told House Republicans as they gathered in Washington for a caucus retreat to open the midterm election year. “You gotta be a little flexible. You gotta work something. You gotta use ingenuity.”
    • “With his suggestion, Trump, who supported abortion rights before he entered politics in 2015, is asking conservatives to abandon or at least ease up on decades of Republican orthodoxy on abortion and spending policy — something lawmakers and conservatives pushed back on immediately.
    • “At the same time, he is demonstrating his long-standing malleability on abortion and acknowledging that Democrats have the political upper hand on health care after Republicans, who control the White House, the Senate and the House, allowed the expiration of premium subsidies for people buying Affordable Care Act insurance policies. As negotiations on Capitol Hill continue on the matter, some Democrats are pushing to end the Hyde restrictions as part of any new agreements on health care subsidies.”
  • The Wall Street Journal relates,
    • “Republican Rep. Doug LaMalfa, who represented a district in Northern California for 13 years, has died, shocking colleagues and further narrowing the GOP’s slim majority. 
    • “Colleagues of LaMalfa, 65 years old, praised the farmer and former state legislator for his long record of advocating for rural communities and farmers.” * *. *
    • “LaMalfa’s death further shrinks the already thin House GOP majority to 218-213. Rep. Marjorie Taylor Greene (R., Ga.) formally resigned from the House in the middle of her term this week. There are now four empty seats—two in red-leaning districts, and two in blue districts. 
    • “Also, Rep. Jim Baird (R., Ind.) was in a car accident, sidelining him at least temporarily. His office said he was in the hospital and is expected to make a full recovery.”
  • Federal News Network gives us an update on implementation of the Federal Acquisition Regulation overhaul.
    • “The Office of Federal Procurement Policy (OFPP) and the FAR Council have issued FAR Companion guides and practitioner albums to help the training and education of the acquisition workforce on the new rules.
    • “Additionally, OFPP Administrator Kevin Rhodes held a series of roundtables with contractors, industry associations and others to gain their perspectives of the FAR overhaul. OFPP says these contractors and associations “shared feedback on five priority goals: increasing competition, reducing costs, accelerating the acquisition system, changing cultural norms and deploying best practices.”
    • “Rhodes said in a statement that “the feedback we received will help inform our efforts for the next phase of the RFO.”
    • “OFPP is accepting more feedback through Jan. 12 through its IdeaScale on ways to continue to improve the FAR across the five priorities.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released updated resources on the 988 Suicide and Crisis Lifeline. An updated fact sheet features an overview of the 988 hotline and what people can expect when using the service. It also includes testimonials from individuals who have used it and an FAQ. Another resource highlights key differences between 988 and 911 and explains when the use of each service is appropriate. SAMHSA also provides digital assets on the 988 hotline for sharing on social media.” 

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “Amneal Pharmaceuticals received FDA approval for two denosumab biosimilars referencing Prolia and Xgeva.
    • “The approval, announced Dec. 22, covers Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz), both used to treat conditions related to bone loss and cancer. The drugs are administered by a healthcare provider and are intended to improve access to lower-cost biologic therapies.
    • “With the addition of the new products, Amneal expects to commercialize six biosimilars across eight presentations by 2027. U.S. sales for Prolia and Xgeva totaled about $5.3 billion in the 12 months ending October 2025.” 

From the public health and medical / Rx research front,

  • AP reports,
    • “U.S. flu infections surged over the holidays, and health officials are calling it a severe season that is likely to get worse.
    • “New government data posted Monday [January 5] — for flu activity through the week of Christmas — showed that by some measures this season is already surpassing the flu epidemic of last winter, one of the harshest in recent history.
    • “The data was released the same day that the Trump administration said it will no longer recommend flu shots and some other types of vaccines for all children.
    • “Forty-five states were reporting high or very high flu activity during the week of Christmas, up from 30 states the week before.
    • “The higher numbers appear to be driven by the type of flu that’s been spreading, public health experts say.
    • “One type of flu virus, called A H3N2, historically has caused the most hospitalizations and deaths in older people. So far this season, that’s the type most frequently reported. Even more concerning, more than 90% of the H3N2 infections analyzed were a new version — known as the subclade K variant — that differs from the strain in this year’s flu shots.”
  • STAT News adds,
    • “Australia’s 2025 flu season lasted weeks longer than it normally does. Hong Kong’s hit so early that the rollout of seasonal flu shots hadn’t yet started. New York has reported record-breaking flu hospitalizations for the past two weeks. 
    • “Welcome to the winter of subclade K.” * * *
    • “Influenza viruses come in many forms, but the ones that cause the most disease in humans are the flu A viruses H1N1 and H3N2, and influenza B. 
    • “Subclade K is a variant of the H3N2 family of viruses, which can trigger more severe seasons and which seem to be harder on older people, who are among the most vulnerable to flu.” * * *
    • “Subclade K viruses weren’t on the radar when influenza experts from around the globe gathered last February to select the strains the 2025-2026 flu shots should target. 
    • “Even when the vaccine contains viruses that are well matched to those that are circulating, the H3N2 component often under-performs. It offers protection against severe disease, but may not prevent infection.”
  • Beckers Hospital Review informs us,
    • “The U.S. has recorded 7,045 clinical Candida auris cases as of Dec. 20 — a 56.1% increase from the 4,514 cases logged in 2023, according to CDC data. 
    • “About half of those cases are in Nevada and California, which each reported about 1,500 C. auris clinical cases in 2025. 
    • “C. auris is an emerging multidrug-resistant fungus that can cause infections and spread quickly in healthcare settings, particularly among immunocompromised patients.”
    • The article lists the number of 2025 C. auris cases in each State.
  • Health Day lets us know,
    • “Telehealth might not be the best option for a parent with a sick baby or toddler, a new study says.
    • “Children 3 months to 2 years of age are nearly 50% more likely to land in an ER within three days of a virtual doctor’s visit than those who have an in-person visit, researchers recently reported in JAMA Network Open.
    • “Our study showed that children under 2, whose communication of their needs and symptoms is more subtle, should probably be seen in person,” senior investigator Dr. Natasha Saunders said in a news release. She’s a pediatrician and senior associate scientist with The Hospital for Sick Children in Ontario, Canada.”
  • Per a National Institutes of Health news release,
    • “In a world first, a team of researchers at the National Institutes of Health (NIH) and Emory School of Medicine, Atlanta, has successfully performed a coronary artery bypass — a normally open-heart surgery — without cutting the chest wall. The team employed a novel intervention to prevent the blockage of a vital coronary artery, which is a very rare but often lethal complication following a heart-valve replacement. The results suggest that, in the future, a less traumatic alternative to open-heart surgery could become widely available for those at risk of coronary artery obstruction.
    • “Achieving this required some out-of-the-box thinking but I believe we developed a highly practical solution,” said first author of the study Christopher Bruce, MBChB, an interventional cardiologist at WellSpan York Hospital and NIH’s National Heart, Lung, and Blood Institute (NHLBI), as well as an adjunct assistant professor of cardiology at Emory School of Medicine.”
  • The Washington Post relates,
    • “The stimulants Ritalin and Adderall have been used to treat attention-deficit/hyperactivity disorder (ADHD) for decades, but research shows they don’t act on the brain’s attention circuitry as had long been assumed.
    • “Instead, the medications primarily target the brain’s reward and wakefulness centers, according to a new study published in the journal Cell. The research, which used brain imaging data from almost 5,800 children ages 8 to 11, also pointed toward the important role that lack of sleep plays in the disorder.
    • “When I first saw the results, I thought I had just made a mistake because none of the attention systems are changing here,” said Benjamin Kay, one of the study’s authors and a professor of neurology at Washington University School of Medicine in St. Louis.
    • “It’s not that the stimulants are ineffective.
    • “The paper clearly shows that they help,” said Nico Dosenbach, another of the authors and a professor of neurology at the university. “They help kids who have a diagnosis of ADHD do better in school and do better on tests, and they help kids who don’t sleep enough ― and a lot of Americans don’t sleep enough.”
  • STAT News points out,
    • “Arrowhead Pharmaceuticals said Tuesday that its gene-silencing candidates helped people with obesity lose fat, very early results that could intensify the competition among biotechs to develop longer-lasting weight loss drugs.
    • “In an ongoing Phase 1/2 study, a cohort of patients took two doses of a candidate called ARO-INHBE, spaced one month apart, in combination with Eli Lilly’s Zepbound. They lost 9.4% of their weight after 16 weeks, while those on Zepbound alone lost 4.8%. These data were from patients with obesity and diabetes, who typically don’t lose as much weight on treatments as those who don’t have diabetes.”
    • “Participants on the combination also lost 23% of their visceral fat, the most harmful type of fat that’s stored around the organs, as well as 15% of their total fat and 77% of their liver fat. Excess liver fat can lead to inflammation and scarring in the organ. Meanwhile, those taking Zepbound alone lost 7%, 5%, and 20%, respectively.
    • “While the drug was effective in combination with Zepbound, it’s not clear yet if it can be a viable product on its own. Obese patients taking only two doses of ARO-INHBE experienced a 16% placebo-adjusted reduction in visceral fat, but that has not yet translated into significant overall weight loss, CEO Christopher Anzalone said.”
  • Per BioPharma Dive,
    • “Immune drug developer Alumis said on Tuesday that its top prospect has succeeded in two Phase 3 trials, helping people with psoriasis eliminate most of their skin lesions after four months of treatment. 
    • “Called envudeucitinib, the drug is a newer type of medicine aimed at a popular target known as TYK2. The first TYK2 blocker, Bristol Myers Squibb’s Sotyktu, was approved in 2022. But Alumis, Takeda and many other biotechs are working on successor drugs and testing them against psoriasis and other immune disorders. Takeda’s medicine produced positive Phase 3 results in December.
    • “Alumis’ data, though, suggest that envudeucitinib has the potential for “class-leading” TYK2 inhibition and a treatment effect approaching what’s observed with injectable biologics, wrote Leerink Partners analyst Thomas Smith. Company shares more than doubled in morning trading, changing hands at around $17 apiece. The company intends to seek U.S. approval of envudeucitinib later this year.” 
  • Per Fierce Pharma,
    • “Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 showing.
    • “In the phase 3 Tulip-SC trial, 56.2% of patients with systemic lupus erythematosus (SLE) who received a subcutaneous dose of Saphnelo experienced a reduction in disease activity at week 52, the company reported Tuesday. In the placebo group, the result was 37.1%.
    • “The readout adds more detail to the trial’s prior interim analysis, which confirmed a statistically significant result for subcutaneous Saphnelo and a safety profile on par with the currently marketed intravenous infusion version.” 

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

  • The Wall Street Journal reports,
    • “Eli Lilly is in advanced talks to acquire Ventyx Biosciences for over $1 billion.
    • “Ventyx specializes in one of the hottest spaces in drug development, developing pills to treat diseases like Crohn’s and rheumatoid arthritis.
    • “The acquisition would enhance Eli Lilly’s portfolio in autoimmune conditions, obesity, and related disorders.”
  • Modern Healthcare tells us,
    • The University of Alabama at Birmingham Health System acquired Southview Medical Group Jan. 1, the system said Jan. 5. 
    • Under the agreement, UAB Health owns all of Southview Medical’s facilities and will employ its more than 30 providers. 
    • Southview Medical had locations at two UAB facilities, UAB St. Vincent’s Birmingham and UAB Medicine St. Vincent’s One Nineteen, prior to the acquisition.
  • and
    • RWJBarnabas Health announced Jan. 5 that it signed a definitive agreement to make Englewood Health part of its system. 
    • Financial details were not disclosed, but RWJBarnabas said it plans to make “significant capital investments” that will improve care access and quality. The transaction is pending regulatory approval. 
    • A timeline for when the deal would be completed was not disclosed.
  • and
    • “A joint venture between Kaiser Permanente and healthcare investment firm Town Hall Ventures has launched a second integrated program for older adults in California.
    • “Habitat Health opened its Program of All-Inclusive Care for the Elderly center in Compton, California, on Thursday. It began enrolling eligible adults older than age 55 last month, a Habitat Health spokesperson said. 
    • “The company plans to roll out other PACE programs in California and expand to Illinois, the spokesperson said.”
  • Fierce Healthcare informs us,
    • “Health system and hospital executives see the promise of automation and artificial intelligence to customize patient outreach and help address persistent engagement challenges.
    • “AI-powered personalization technology can nudge patients to take action, which could help address long-standing challenges with medication adherence while also reducing no-show rates and closing care gaps. 
    • “According to a recent survey from Lirio and Sage Growth Partners, 60% of executives from U.S. health systems, independent hospitals and physician groups cited automating patient outreach to ease administrative burden as their top priority. Most executives (96%) said AI and automation can reduce administrative burden related to patient engagement. About half of executives said their organizations struggle to personalize engagement content, such as text messages or emails, at the patient level.
    • “But this operational priority doesn’t currently match up with AI investment strategies.
    • “Among the surveyed executives, 35% said their organizations have yet to make investments in AI tools for patient outreach. At the same time, most health systems are channeling AI investment into operational efficiency. The majority of executives (83%) said their organization has invested in AI-based solutions for automated documentation and other tasks to improve clinician workflows.
    • “The disconnect between AI priorities and investments often comes down to the speed at which different technologies demonstrate value,” Amy Bucher, M.D., chief behavioral scientist at Lirio, told Fierce Healthcare.” 

Friday Report

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Government Contracting, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A dispute over a Trump administration plan to consolidate federal firefighting operations may be close to resolution, in a sign of modest progress toward Senate passage of a major fiscal 2026 spending package.
    • “Sen. Tim Sheehy, R-Mont., said Thursday he was prepared to release his hold on the Interior-Environment bill, a prime candidate for the “minibus” spending package, after cutting a deal to remove language that threatened to delay, if not derail, the firefighting reorganization.
    • “Sheehy, a former firefighting pilot and founder of an aerial firefighting and aerospace services company, is a key backer of the plan and rejected any effort to delay it.
    • “But we’ve cleared that language, so we should be good now,” he said.” * * *
    • “While Sheehy’s hold on the spending package may be lifted, Thune continued to negotiate with several other Republicans who have their own holds as they push for various causes, including a concern from some conservatives that spending levels are too high.
    • “Thune, R-S.D., told reporters Thursday that negotiators were still working “through the concerns that our members have,” but added he’s hopeful they “can land something soon.”
    • “A lot of conversations going on around that, but we just need to — we’ve got to get on the package of bills,” Thune said.
    • “Thune wants to add some combination of the Commerce-Justice-Science, Interior-Environment, Labor-HHS-Education and Transportation-HUD bills to the Defense bill in a package he could bring to the floor in coming days.”
  • Fierce Healthcare adds,
    • “As Congress continues to debate next steps on the Affordable Care Act’s enhanced subsidies, insurers are urging legislators to consider an extension with additional program integrity measures in place.
    • “AHIP said in a statement Wednesday that “common sense” steps to promote integrity can help mitigate the risks related to fraudulent enrollment in ACA plans or subsidies. The commentary comes after analysts at the Government Accountability Office were largely able to enroll in coverage and in the tax credits using fake profiles.
    • “GAO notes in the report that when the Centers for Medicare & Medicaid Services took steps to address fraudulent enrollments by improving identity verification and implementing three-way calls to stymie broker misbehavior, which have already had an impact on reducing unauthorized activity, AHIP said.
    • “With open enrollment underway and 24 million Americans facing the largest-ever spike in healthcare costs in 2026, Congress should take bipartisan action to preserve the health care tax credits and further strengthen program integrity,” AHIP said.”
  • The American Hospital Association News tells us,
    • “The Advisory Committee on Immunization Practices Dec. 5 recommended individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. If not receiving the vaccine at birth, ACIP recommended infants receive the initial dose no earlier than 2 months of age. However, ACIP made no change to the existing Centers for Disease Control and Prevention recommendations to vaccinate infants born to women who test positive for the virus or have an unknown virus status. The recommendations also maintain consistency with all current health coverage options for payment, according to the Department of Health and Human Services. ACIP’s recommendations must be formally adopted by the director of the CDC before becoming part of the CDC immunization schedule.”
  • The Wall Street Journal explains what the ACIP recommendations means for readers.
    • “Under these recommendations, parents who wish to have their infants vaccinated at birth, if the mother isn’t infected with hepatitis B, will be able to do so after discussing it with their doctor. Doctors might face additional hurdles in administering the vaccine at birth for some families, including additional time spent counseling. 
    • “Insurers will likely still cover the shots if administered earlier than recommended. AHIP, a group representing insurers, said its members will cover vaccines recommended by ACIP through Sept. 1 until the end of 2026. Insurers typically handle coverage decisions yearly.”
  • Healthcare Dive lets us know,
    • “The HHS on Thursday released its plan to deploy and centralize artificial intelligence use within the agency, as part of a broader push by the Trump administration to cut costs and adopt the technology in the federal government.
    • “The agency said it will prioritize sharing AI resources among HHS departments, create a governance structure for new tools and promote use of the technology for public health initiatives.
    • “Although the strategy is internally focused to start, HHS said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.” 
  • FedWeek calls to our attention a hiccup in the relatively new PSHBP Open Enrollment system that may require enrollee work arounds.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.
    • “Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
    • “We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
  • Per MedTech Dive,
    • “Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications.
    • “Members of the circulatory system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
    • “J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
    • “Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
    • “We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
      • “Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds
    • “Although this year’s flu season could be challenging, fewer adults have been vaccinated against influenza, a new study shows.
    • “Much less than half of US adults have been immunized against any respiratory virus, according to a survey of 1,015 adults released this week by the National Foundation for Infectious Diseases (NFID).
    • “Just 34% of adults have gotten a flu shot; 25% have had a COVID-19 shot; 8% have received a vaccine to prevent pneumococcal disease, caused by bacteria that can lead to pneumonia, meningitis, and sepsis; and 6% have been vaccinated against respiratory syncytial (RSV), a leading cause of hospitalization in infants and older adults.
    • “New data from IQVIA, which provides health care statistics, show similar declines over the past year. Retail pharmacies have seen falling numbers of vaccinations for three major respiratory viruses:
      • “34% decline in RSV vaccinations
      • “27% drop in COVID-19 vaccinations
      • “6% reduction in flu shots
    • “Pneumococcal vaccinations are the one bright spot in IQVIA’s data, with vaccinations rising 27% in the past year. The uptick is likely due to the Centers for Disease Control and Prevention’s (CDC’s) decision last year to lower the age at which people are eligible for pneumococcal vaccine from 65 to 50, said Robert Hopkins, NFID’s medical director.
  • Beckers Clinical Leadership tells us,
    • “Twelve percent of nearly 3,000 norovirus tests during the week ending Nov. 22 came back positive — a notable increase from the 6.82% positivity rate three months earlier, according to CDC data. 
    • “During the week ending Aug. 23, 6.82% of 4,034 norovirus tests were positive. A CDC system that tracks viral activity in the U.S. shows a 12% positivity rate among 2,825 norovirus tests, as of Nov. 22, the most recent data available.” 
  • Per Medscape,
    • “A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.
    • “The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.
    • “The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.
    • “The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.”
  • and
    • “Current cardiac screening tools used to prevent myocardial infarction (MI) failed to identify nearly half of people who are at risk for MI, according to a new study. Those patients had low or borderline risk as per both standard and newer risk calculators for atherosclerotic cardiovascular disease (ASCVD). Most developed symptoms within 48 hours before the event, and many would not have been recommended statins or further testing if evaluated 2 days earlier.”
  • MedPage Today informs us,
    • “In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.
    • “After standardizing characteristics between the two groups, all-cause mortality incidence was 25% lower in those who had received a COVID shot.
    • “Vaccinated people were 74% less likely to die in a hospital because of COVID-19 compared with those who weren’t vaccinated.”
  • and
    • “Three ancillary studies to the U.S. POINTER trial collectively demonstrated that a structured 2-year lifestyle intervention for older adults at increased risk of cognitive decline led to better overall health.
    • “In main results from the U.S. POINTER trial released in July, two lifestyle interventions — one structured, the other self-guided — improved cognitive scores in over 2,000 older adults, said Rema Raman, PhD, of the University of Southern California in Los Angeles, who co-chaired a symposium at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
    • “Both 2-year interventions in U.S. POINTER encouraged physical activity, cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but they differed in structure, intensity, and accountability.
  • Per Health Day,
    • “Your brain health might be linked to how well your kidneys are working, a new study says.
    • “People with impaired kidney function have higher levels of proteins in their blood that are linked to Alzheimer’s disease, researchers reported Dec. 4 in the journal Neurology.
    • “Our study found that when the kidneys are not functioning properly, there may be higher levels of Alzheimer’s biomarkers in the blood,” lead researcher Dr. Francesca Gasparini, a geriatrician with the Karolinska Institutet in Stockholm, Sweden, said in a news release.
    • “While we did not find that having reduced kidney function increased the risk of developing dementia, we did find that impaired kidney function may accelerate the onset of dementia in people who have higher levels of biomarkers.,” Gasparini said. “This highlights the need for doctors to consider kidney function when interpreting results of Alzheimer’s biomarkers in the blood.”
  • STAT News reports,
    • “Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.
    • “Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.”

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

  • Tech Target relates,
    • “Navigating an evolving regulatory landscape is top-of-mind for healthcare payers heading into 2026, with health plan executives saying changing requirements stemming from the Trump tax law has driven new priorities, according to a new HealthEdge report.
    • “The report, based on survey responses from 550 health plan executives in the United States, also flagged rising costs, better member engagement, investment in artificial intelligence (AI) and more collaborative payer-provider relationships as key priorities.”
  • McKinsey & Co. points out,
    • “Women in the United States face steeper barriers to healthcare than men, causing preventable suffering and costing billions each year. The health of women—encompassing the entire care continuum and extending beyond reproductive and sexual health—represents an approximately $50 billion missed annual opportunity for health systems nationally. Addressing the gap in women’s healthcare requires a fundamental transformation in care delivery, with preventive care playing a pivotal role to ensure accessibility, continuity, and comprehensive care.”
  • BioPharma Dive notes,
    • “Hemophilia gene therapies are struggling on the market, even as innovation soars. The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.”
  • Per Fierce Healthcare,
    • “It’s been just over a year since Oura announced a partnership with Medicare Advantage insurer Essence Healthcare, and, now, the partners are looking to continue building on that foundation.
    • “The partnership initially launched for Essence’s PPO plan members, and, over the course of the year, grew into HMO plans as well. Saria Saccocio, M.D., chief medical officer for Essence, told Fierce Healthcare that a third of members who were eligible for an Oura ring chose to sign up, and two-thirds of that group was willing to share biometric data with the insurer.
    • “She said the effort began with sleep health and, over time, has shown members are improving their sleep scores. That’s translating to other areas as well, such as an increase in the amount of time engaging in light exercise.
    • “It’s that level of awareness and nudge that I think is helping improve the overall health of our members,” Saccocio said.”
  • and
    • “Wellvana has struck a 20-year affiliation with Mercy that will offer the system’s nonemployed primary care physicians and advanced practice providers participation in value-based care.
    • “The arrangement will give those independent clinicians access to Wellvana’s electronic-health-record-integrated practice tools and clinical and operational care teams, which the new partners say will reduce administrative burdens and help coordinate patient care.
    • “The providers’ participation in value-based arrangements will also bring financial incentives for better patient outcomes within Mercy’s service area and across Medicare, Medicare Advantage and commercial plans, they said. The organizations expect their clinically integrated network to be among the country’s largest.
    • “Mercy has built one of the nation’s most respected systems, and together we’re creating sustainable paths for independent providers to see the rewards of accountable care,” Wellvana CEO Susan Diamond said in Thursday’s announcement. “The more we grow participation in value-based care, the more patients and communities benefit from a better, more connected health experience.”
  • The Wall Street Journal offers readers six questions to ask their doctors before their doctors use AI to record their visits.

Monday report

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump signaled a willingness to strike a deal on funding healthcare subsidies demanded by Democrats, as the government shutdown entered its second week. 
    • “We have a negotiation going on right now with the Democrats that could lead to very good things,” Trump told reporters in the Oval Office on Monday. 
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) said formal talks hadn’t commenced. “Trump’s claim isn’t true. But if he’s finally ready to work with Democrats, we’ll be at the table,” he said in a statement.” * * *
    • “After Trump’s comments on Monday, Sen. Markwayne Mullin (R., Okla.) said he had spoken with Democrats and the president in an informal way about healthcare, but funding the government must come first. “Once they reopen the government, we’ll be happy to talk about the way we make healthcare better for the American people,” he said.” * * *
    • “At a press conference late Monday, House Minority Leader Hakeem Jeffries (D., N.Y.) said he hadn’t heard from Trump, but it was “an interesting statement that the president has made.” He said that he would be willing to talk with Trump or White House officials at any time.” 
       
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations by the Advisory Committee on Immunization Practices. Patients are now advised to consult their health care provider if they want to receive a COVID-19 vaccine, which would be covered by health insurance like other routine vaccines. In addition, it is now recommended that children through age 3 receive a standalone chickenpox vaccine rather than the combined measles, mumps, rubella and varicella vaccine.”
  • The Washington Post adds,
    • “What does it mean to consult a clinician [/ their health care provider?
    • “The CDC website lists health care providers who can be involved in discussing vaccines with patients. They include anyone else who provides or administers vaccines, including primary care physicians, specialists, pharmacists, physician assistants, nurse practitioners and registered nurses.
    • “That means a person doesn’t necessarily need to make a doctor’s appointment to get a vaccine.
    • “Pharmacists are trained to discuss pros and cons of all medications with patients, including coronavirus vaccines.”
  • Per Health Day,
    • “The U.S. Food and Drug Administration is considering changes to a 20-year-old warning on menopause hormone therapy
    • “Experts say the warning has discouraged safe use of treatment for hot flashes, poor sleep and other symptoms
    • “Research suggests hormone therapy can be safer and more effective when started earlier in menopause.”
  • Bloomberg Law points out,
    • “A new regulatory pilot project from the US Centers for Medicare and Medicaid Services is under review at the White House budget office, suggesting that the Trump administration is seeking to take regulatory action against drugmakers even as it strikes deals with individual companies.
    • “There are no details about the policy CMS plans to test, titled the “Guarding US Medicare Against Rising Drug Costs” pilot, including what drugs or companies could be impacted. Regulatory pilot projects help the government determine if a new regulation will save money, allowing it to experiment with rules before implementing them widely.
    • “The proposed regulation is the agency’s second recent move toward new rules on drug prices; another posted on Sept. 25.”
  • Healthcare Dive informs us,
    • “Arbitration of surprise billing disputes between insurers and providers will continue despite the government shutdown, the CMS said on Friday.
    • “Parties that disagree over how much an out-of-network claim should be reimbursed can still submit disputes via the federal independent dispute resolution portal, and arbiters will continue to process disputes, according to the agency.
    • “However, a prolonged shutdown could throw a wrench in other processes that underlie the implementation of the No Surprises Act, which was passed in 2020 to protect consumers from unexpected out-of-network bills. Since congressional appropriations lapsed last week, Congress has made no progress on a deal to reopen the government.”
  • The Healthcare Financial Management Association lets us know that “No Surprises Act arbitration has been a bonanza for a few provider groups. For-profit provider companies have fared well in the NSA’s independent dispute resolution portal even as the process remains a frequent subject of litigation.”
    • “In a span of 2.5 years through 2024, providers reaped more than $2.2 billion from the No Surprises Act’s arbitration process, relative to the applicable in-network payment rates for the disputed care episodes.
    • “The awards received through the NSA’s independent dispute resolution (IDR) process largely arise from “disputes that are primarily initiated and won by private-equity-backed providers,” said Kennah Watts, research fellow at the Center on Health Insurance Reforms at Georgetown University.
    • “Driven by that handful of groups, the volume of IDR disputes “continues to surpass agency estimates by millions,” Watts said during a webinar presented by Health Affairs.”
    • “Although the involvement of private equity (PE) frequently raises questions in healthcare, some smaller providers might struggle to effectively engage with the IDR process if not for that support, panelists noted during a discussion as part of the webinar.”
  • Per Govexec,
    • “Dr. Kevin Rhodes has received Senate confirmation to lead the White House’s Office of Federal Procurement Policy, a move that designates him as the first permanent leader of that component in six years.
    • “Senate lawmakers approved the nomination of Rhodes on Thursday, five months after the White House announced him as President Trump’s choice for the role.
    • “Rhodes has been acting as a senior adviser to OFPP’s parent agency, the Office of Management and Budget, since February with the responsibility of leading the Trump administration’s push to restructure federal procurement.
    • “All but one section of the Federal Acquisition Regulation has been overhauled since then. OFPP and the FAR Council have collaborated on the effort and gradually rolled out the changes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Immunologists Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi were awarded the Nobel Prize in Physiology or Medicine for uncovering a process that prevents the immune system from attacking our own tissues, called peripheral immune tolerance. The work unlocked a new field of research and potential therapies.
    • “The trio identified a core feature of how the immune system functions and keeps itself in-check: regulatory T-cells. They prevent other immune cells from harming our own bodies and developing autoimmune conditions including Type 1 diabetes and rheumatoid arthritis. Based on this fundamental knowledge, clinical trials are ongoing to test therapies for autoimmune diseases, cancer and post-organ transplantation.
    • “Their discoveries have been decisive for our understanding of how the immune system functions and why we do not all develop serious autoimmune diseases,” said Olle Kämpe, chair of the Nobel Committee on Monday.
    • “Brunkow is now based at the Institute for Systems Biology in Seattle, Ramsdell at the San Francisco and Seattle-based Sonoma Biotherapeutics, while Sakaguchi is a distinguished professor at Japan’s Osaka University. The group will share the 11 million Swedish kronor, or roughly $1.1 million, prize.”
  • Heath Day reports,
    • “An alarming trend is emerging on America’s roads.
    • “More drivers killed in crashes are testing positive for THC, the active ingredient in marijuana.
    • Researchers in Ohio reviewed autopsy records from 246 drivers killed in crashes between 2019 and 2024.
    • “They found that 41.9% had THC in their system — at levels far above what most states consider impairment.
    • “The average blood level was 30.7 nanograms per milliliter. By comparison, many states set legal limits between just 2 and 5.
    • “The researchers say that means the drivers likely used marijuana close to the time of the crash. The study also found the high rate of THC positivity stayed consistent over six years and didn’t change when recreational pot became legal in Ohio in 2023.
    • “The lead author says from a public health standpoint, there hasn’t been enough attention on the dangers of legalization.”
  • and
    • “When someone has whooping cough, the sound can be unmistakable: A deep, gasping “whoop” as they struggle to catch their breath between fits of coughing. 
    • “Now, this once-rare illness, also known as pertussis, is making a comeback across the United States.
    • “Cases have now surpassed pre-pandemic levels, and while the disease can be exhausting for adults, experts warn it can be life-threatening for newborns and infants, especially those under two months old.
    • “Most babies in this age group who contract pertussis are hospitalized, according to a report published Oct. 3 in the journal Pediatrics.”
    • “Pertussis symptoms are different in infants,” said lead author Dr. Caitlin Li, an infectious diseases specialist at Ann & Robert H. Lurie Children’s Hospital of Chicago and assistant professor of pediatrics at Northwestern University Feinberg School of Medicine. “The characteristic whooping cough may be absent, but apnea, or breathing interruption, is common.” * * *
    • “Given that infants are at high risk for complications, pertussis vaccination of mothers during pregnancy is critical, as it protects newborns against this potentially fatal illness,” Li explained in a news release. “Widespread vaccination is also an important tool to protect everyone.”
  • The American Cancer Society lets health plans know “how to address cancer care gaps to improve cost and clinical outcomes at every step.”
  • Genetic Engineering and Biotechnology News discusses the largest genetic map of human metabolism ever created.
    • “The contribution of genetics to the variability in people’s metabolism has remained largely unknown. This is, in part, because genetic studies of human metabolism have been limited in scale and allelic breadth. Now, the largest genetic map of human metabolism has been created, revealing new insights on the role of metabolites in health and disease and creating a blueprint for further research.
    • “This work is published in Nature Genetics in the paper, “A genetic map of human metabolism across the allele frequency spectrum.”
  • Per Healio,
    • “Adults with obesity who reported more intense tastes while receiving semaglutide or tirzepatide had a higher likelihood for increased satiety and decreased appetite and food cravings, according to a presenter.
    • “In a cross-sectional study presented at the European Association for the Study of Diabetes annual meeting and published in Diabetes, Obesity and Metabolism, researchers surveyed adults with obesity who were using semaglutide (Ozempic/Wegovy, Novo Nordisk) or tirzepatide (Mounjaro, Eli Lilly) and asked about changes in their appetite, satiety and sensory perception after starting an incretin-based therapy. Researchers found some adults reported increased intensity of sweet and salty tastes, and increased intensity of both types of tastes were tied with greater odds for increased satiety. However, change in taste did not affect weight-related outcomes.
    • “This means that taste perception changes may serve as markers of appetite response rather than predictors of treatment success,” Othmar Moser, PhD, professor in the division of endocrinology and diabetology in the department of internal medicine at Medical University of Graz in Austria and in the division of exercise physiology and metabolism at the Institute for Sports Science at University of Bayreuth in Germany, told Healio. “The findings highlight the nuanced ways incretin therapies act beyond pure metabolic regulation.”
  • BioPharma Dive relates,
    • “An experimental weight loss drug from Skye Bioscience failed a mid-stage clinical trial, wiping out most of the San Diego biotechnology company’s market value.
    • “Skye said Monday its therapy, an obesity medicine targeting a kind of cannabinoid receptor, didn’t significantly lower weight loss compared to a placebo after 26 weeks of treatment. Patients who received Skye’s drug, nimacimab, achieved only 1.5% weight loss, compared to less than 0.3% for placebo recipients. In a statement, Skye blamed the findings on the dose it chose for the study, arguing an analysis found that a 200 milligram weekly injection is “suboptimal as a monotherapy.”
    • “Nimacimab fared better when paired with semaglutide, the active ingredient in Novo Nordisk’s Wegovy, and tested against semaglutide alone. In that study cohort, patients on the combination lost just over 13% of their body weight, compared to more than 10% for those only on semaglutide. Skye said the findings support the potential for future studies evaluating combinations of nimacimab and other so-called incretin-based therapies widely used for weight loss.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Physician pay is increasing, largely through sign-on bonuses, but higher salaries alone often aren’t enough to retain physicians or attract top-tier talent.
    • “Advanced technology, paid time off and compensation for on-call requirements are just a few of the demands incoming physicians have for potential employers, according to respondents to Modern Healthcare’s 2025 Physician Compensation Survey. This year’s results reflect data from nine staffing and consulting firms, indicating that the trend of rising physician compensation isn’t likely to slow down anytime soon.
    • “If you’re employing physicians or any staff, you’re probably going to have to pay higher wages, particularly now,” said Chad Stutelberg, a managing director at consulting firm Gallagher. “The physicians have more leverage.”
  • Beckers Hospital Review notes,
    • “Rite Aid has closed its final 89 stores, bringing an end to operations after decades as one of the largest pharmacy chains in the U.S.
    • “All Rite Aid stores have now closed. We thank our loyal customers for their many years of support,” the company said on its website.
    • “The company filed for Chapter 11 bankruptcy protection in October 2023 and shuttered 154 stores. It filed again in May after failing to recover. 
    • “The pharmacy chain once operated more than 5,000 stores at its peak and employed about 45,000 people in 2023, including 6,100 pharmacists.”
  • The Washington Post reports,
    • “Popular weight-loss drugs Ozempic and Wegovy are now being sold at below sticker prices at Costco pharmacies across the United States, as rising obesity levels boost demand for the drugs and cheaper copycat versions.
    • “Novo Nordisk’s U.S. president, David Moore, told NBC News that the drugmaker’s push into Costco is a way to “offer the real, authentic Wegovy and Ozempic where patients seek care.”
    • “It comes as the Danish pharmaceutical giant seeks to head off competition from rival manufacturers, after sales of copycat drugs from compound pharmacies soared amid national shortages.
    • “The drugs, which mimic a natural hormone to curb hunger and make people feel full for longer, will be available on prescription to Costco members for an out-of-pocket price of $499 a month.
    • “The current list price of Ozempic is nearly $1,000 per injectable pen while Wegovy is around $1,350.”
  • Beckers Payer Issues tells us nine things to know about confusion among older adults before Medicare open enrollment.
  • Per Fierce Healthcare,
    • “Online therapy provider Talkspace acquired Wisdo Health to integrate peer support and coaching into its mental health services.
    • “Wisdo is an artificial-intelligence-powered coaching and peer-to-peer support platform that gives users 24/7 access to trained peers, moderated communities and group coaching to help combat social isolation and loneliness.
    • “The acquisition will enhance Talkspace’s service line, offering lower-acuity options and complementing existing therapy and psychiatry services. 
    • “Financial terms of the acquisition were not disclosed.”
  • and
    • “Health data company CertifyOS has unveiled its new Provider Hub platform, technology that allows insurers greater insight into key data across their provider network.
    • “Through Provider Hub, payers can tap into unified and real-time provider data that are critical to operations. The company said in an announcement that these data have traditionally been managed in siloed systems, spreadsheets and outdated tools that hinder effective use.
    • “When payers lack access to complete or usable provider data, it can have a negative impact on a slew of key business functions, Certify said, including compliance with key regulations, member experience and claims processing. 
    • “The Provider Hub takes in and cleanses, normalizes and validates key provider data from multiple sources, including credentialing, directories, claims and other internal systems. The platform leans on artificial intelligence to support this effort, according to the announcement.”
  • Per Beckers Health IT,
    • “AI-powered customer engagement company Qualtrics has agreed to acquire healthcare market research firm Press Ganey for $6.75 billion, the Financial Times reported Oct. 6.
    • “Press Ganey, currently owned by investor Ares Management and private equity firm Leonard Green & Partners, conducts surveys on behalf of over 41,000 health systems and other healthcare organizations.
    • “The deal would give Qualtrics, which deploys AI for such uses as ordering food online and rescheduling hotel stays and flights, a foothold in healthcare alongside other tech players including Oracle and Palantir, the Times reported.”