Friday report

Rx coverage

Friday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital News lets us know,
    • “The Senate Oct. 16 failed for a 10th time to advance the continuing resolution to extend government funding and end the ongoing shutdown. The chamber adjourned until Oct. 20, pushing the shutdown into next week. The House continues to remain out of session with no plans to return. Lawmakers remain at an impasse, and no formal negotiations have resumed.”
  • Govexec informs us,
    • “President Trump on Wednesday signed a new executive order effectively indefinitely extending the ongoing hiring freeze, albeit while creating new requirements for federal agencies to obtain exceptions as well as new opportunities to politicize the federal workforce.
    • “Trump’s hiring freeze, first implemented on Jan. 20, was set to expire Wednesday. The new order, entitled Ensuring Continued Accountability in Federal Hiring, requires agencies to create a strategic hiring committee, whose membership should include the deputy agency head and the agency head’s chief of staff, to approve “the creation or filling” of each vacancy within the organization. It also requires the creation and submission to both the Office of Personnel Management and the Office of Management and Budget of an annual staffing plan.
    • “In these plans, agencies shall seek to improve operational efficiency; eliminate duplicative or unnecessary functions and positions; reduce unnecessary or low-value contractor positions; promote employee accountability; enhance delivery of essential service; appropriately prioritize hiring for national security, homeland security and public safety positions; and implement the recruitment initiatives described in the merit hiring plan,” the order states. “Going forward, agencies shall prepare, in coordination with OPM and OMB, annual staffing plans to implement at the start of each new fiscal year.”
  • OPM Director Scott Kupor discusses the new executive order in this week’s post in his Secrets of OPM blog.
    • “The goal of this exercise is not for OPM nor OMB to question the judgment of our very capable agency heads; without a doubt, the “CEOs” of these organizations know their agencies far better than do we. Rather, the goal is to provide a level of pan-government visibility across resourcing in furtherance of the key initiatives that the president has laid out. And, in doing so, we can look for ways to maximize efficiency and deliver the best possible set of services to the American people.
    • “For example, if we learn that collectively across agencies we are looking to hire 10,000 engineers this year, then OPM can help design an x-government process to facilitate more centralized hiring. Or, if we see that there are core personnel resources that are being duplicated across agencies that could be more effectively done via specialization and centralization, OPM can help drive that as well. And this list goes on.
    • “None of this is rocket science. But President Trump rightfully recognizes that the federal government needs to operate on the same fundamental practices that do all modern organizations writ large.
    • “Rationality prevails – at least for now – in DC.”   
  • 401k Specialist points out,
    • “Assets in health savings accounts (HSAs) climbed to $146 billion in 2024, with an 18% year-over-year increase, according to new data out today from Morningstar.
    • “The investment analyst’s latest Health Savings Account Landscape Report notes that the tax benefits associated with HSAs, along with widespread adoption of high-deductible health plans (HDHPs), has accelerated growth among the savings vehicles.
    • “Growing adoption of HDHPs has coincided with HSA asset growth, Morningstar reports. According to the findings, the percentage of workers in employer-sponsored medical insurance plans that have elected HDHPs increased from 7% in 2006 to 32% by the end of 2024. In that same timeframe, HSA assets rose to $146 billion from close to $5 billion about 20 years ago.
    • “In nearly a decade of research, we’ve seen the HSA industry mature considerably as more individuals take advantage of the powerful tax advantages and long-term savings potential these accounts offer,” said Greg Carlson, senior manager research analyst at Morningstar, in a statement.”
  • Fierce Healthcare relates,
    • “A new evidence-based framework aims to establish a U.S. industry standard for measuring health equity efforts.
    • “Put out by the Institute for Healthcare Improvement (IHI), the white paper has been in the works for two years. It offers a four-step approach to help healthcare teams across settings identify health disparities. Advancing health equity is defined in the paper as reducing and eliminating health disparities that adversely affect historically underserved groups.
    • “We’re hoping that this will be a standardized approach to data and measurement,” Nikki Tennermann, IHI senior project director and an author of the white paper, told Fierce Healthcare. “We wanted to make sure that this framework was accessible to big large integrated health systems but also maybe it’s a small local mental health alliance.”
    • “In healthcare, there is no single standard to identify, quantify, track and report health equity gaps in patients, per the paper. The framework aims to address that. More than 35 subject-matter experts representing clinical, quality, payer, academic and administrative roles contributed to the framework.”  
  • Fierce Pharma notes,
    • “Six years since the FDA blessed Sanofi and Regeneron’s Dupixent as the first biologic to treat chronic rhinosinusitis with nasal polyps (CRSwNP), a second biologic therapy has broken through with a nod in the indication.
    • The U.S. regulator has endorsed Amgen and AstraZeneca’s Tezspire as an add-on maintenance treatment for patients age 12 and older. The first-in-class monoclonal antibody, which is injected monthly, inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine which triggers inflammation.
    • It’s this novel mechanism of action that keys the effectiveness of Tezspire, which has produced clinical results that suggest it could become the top product on the market for CRSwNP.”

From the judicial front,

  • Govexec reports,
    • “The Trump administration on Friday vowed to comply with a judge’s order to halt any layoffs caught up in a court-ordered pause on such reductions, though it left the door open to cuts of personnel not currently party to the lawsuit.” * * *
    • “The plaintiffs on Friday filed an amended complaint seeking to add the National Federation of Federal Employees, the National Association of Government Employees and the Service Employees International Union to the case to ensure protection for those workers as well. In an emergency an emergency hearing for Friday evening, the judge on the case agreed to expand her order to include those employees.”  
  • Beckers Payer Issues relates,
    • “Wellmark Blue Cross and Blue Shield has filed a lawsuit against Iowa’s insurance commissioner, challenging the enforcement of a newly enacted state law that regulates pharmacy benefit managers and the administration of prescription drug benefits.
    • “The lawsuit, filed on Oct. 14 in an Iowa federal court, claims that the legislation violates the First Amendment and the Employee Retirement Income Security Act. The lawsuit stems from the Iowa court’s previous ruling in a case involving the Iowa Association of Business and Industry, which had sought to block the bill, and a ruling in July that partially found the law to be invalid.
    • “While the court granted a preliminary injunction in that case and blocked the law’s enforcement against certain plaintiffs, Wellmark argues that the injunction does not extend to other entities like itself, which were not part of the previous lawsuit. Wellmark claims that the enforcement of the new law would harm its business and members by imposing significant costs and regulatory burdens, especially those tied to provisions the court previously found unconstitutional, including anti-referral and anti-promotion requirements for pharmacies and PBMs.
    • “The complaint also argues that many provisions of the law violate ERISA’s preemption provisions and impose regulations that interfere with the administration of ERISA plans. Wellmark has requested an injunction to block enforcement of the provisions that have been enjoined in the other lawsuit, as well as additional provisions that affect its role in administering ERISA-covered plans.” 
  • The Miller & Chevalier law firm observes,
    • “Air ambulance providers Guardian Flight, LLC, and Med-Trans Corporation, both of whom lost their bids to sue payors in court for payment of No Surprises Act (NSA) Independent Dispute Resolution (IDR) determinations, petitioned the U.S. Supreme Court on October 8, 2025, seeking to overturn a Fifth Circuit decision finding no private right of action under the NSA. Guardian Flight, L.L.C., et al. v Health Care Service Corporation, No. 25-441 (U.S.).” * * *
    • “The majority of federal courts that have addressed the issue of whether the NSA provides a private right of action have decided it does not and the Fifth Circuit is the only federal appellate court to rule on this issue. Without a circuit split, it will be surprising if the Court takes up this issue at this time.” 

From the public health and medical / Rx research front,

  • Per the University of Minnesota’s CIDRAP,
    • “In a precursor to what we might expect in the coming flu season in the United States and across the Northern Hemisphere, a new study shows flu vaccine effectiveness (VE) to be around 50% for both clinic visits and hospital stays for influenza during the 2025 Southern Hemisphere flu season.
    • “The findings, which demonstrate that the vaccine cuts the rate of medical care for flu in half, were published recently in Morbidity and Mortality Weekly Report by researchers with the US Centers for Disease Control and Prevention (CDC), the Pan American Health Organization, and their collaborators in Southern Hemisphere nations.
    • “CDC recommends that all eligible persons aged ≥6 months receive the seasonal influenza vaccine,” the authors note. “The 2025–26 Northern Hemisphere seasonal influenza vaccine composition is the same as that used during the 2025 Southern Hemisphere influenza season and might be similarly effective if the same viruses circulate in the coming season.”
  • Beckers Clinical Leadership tells us,
    • “U.S. adult obesity prevalence has dipped slightly year over year, with fewer states reporting obesity rates at or above 35%. However, the nation continues to face a high overall obesity rate.
    • “That’s according to a new report released Oct. 16 by Trust for America’s Health.
    • “Nineteen states had adult obesity rates at or above 35% last year, down from 23 in 2023, according to “The State of Obesity: 2025,” which is based in part on TFAH’s analysis of 2024 CDC data, and recent data from the 2021-2023 “National Health and Nutrition Examination Survey.”
    • “Still, the analysis found that slightly more than 4 in 10 U.S. adults have obesity, and rates are rising among children and adolescents, with more than 21% of those ages 2 to 19 affected.”
  • Health Day adds,
    • “A new definition of obesity could dramatically increase the number of Americans considered obese.
    • “Under the new definition, the prevalence of obesity rose from around 40% to nearly 70% among more than 300,000 people participating in a long-term health study, researchers reported Oct. 15 in JAMA Network Open.
    • “The new definition takes into account additional measures of excess body fat rather than just relying on body mass index (BMI). BMI is an estimate of body fat based on height and weight.
    • “We already thought we had an obesity epidemic, but this is astounding,” said co-lead researcher Dr. Lindsay Fourman, an endocrinologist at Mass General Brigham in Boston.
    • “With potentially 70% of the adult population now considered to have excess fat, we need to better understand what treatment approaches to prioritize,” she said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “The gut microbiome has been increasingly connected to a myriad of conditions, in part due to the metabolic output of the microbes in the gut. Studies have suggested that exposure to carcinogens or toxins can have a broader impact on health. The brain-gut microbiome connection has also been under investigation. How the gut microbiome impacts the brain’s response to and preference for alcohol has not yet been thoroughly explored.
    • “Researchers at Tufts University have found a connection between a gut fungus, Candida albicans, and the dopamine pathway in the brain. Their paper titled, “Candida albicans colonization modulates murine ethanol consumption and behavioral responses through elevation of serum prostaglandin E2 and impact on the striatal dopamine system,” was published in mBio.” * * *
    • “While many treatments for alcohol use disorder hinge on behavioral modifications, exploration of alternative approaches, including therapies involving the gut microbiome, may be a promising path. “We are excited to learn more about the mechanisms that allow microbes to affect host behavior,” shared [the researchers] Kumamoto and Day with GEN.” 
  • and
    • “Faulty brain circuits seen in Down syndrome may be caused by the lack of a particular molecule essential for the development and function of the nervous system, according to a new study in lab mice. Restoring the molecule, called pleiotrophin, could improve brain function in Down syndrome and other neurological diseases, possibly even in adults, the researchers say.
    • “The scientists conducted their work in mice, rather than in people, so the approach is far from being available as a treatment. But the researchers found that administering pleiotrophin improved brain function in adult mice long after the brain was fully formed. That suggests that the approach could offer major advantages over prior attempts to enhance Down syndrome brain circuits that would have required intervention at extremely precise, and brief, times during pregnancy.
    • “This study is exciting because it serves as proof-of-concept that we can target astrocytes, a cell type in the brain specialized for secreting synapse-modulating molecules, to rewire the brain circuity at adult ages,” said researcher Ashley N. Brandebura, PhD, who was part of the research team while at the Salk Institute for Biological Studies and is now part of the University of Virginia School of Medicine. “This is still far off from use in humans, but it gives us hope that secreted molecules can be delivered with effective gene therapies or potentially protein infusions to improve quality of life in Down syndrome.”
  • The Wall Street Journal reports on human longevity research focused on people living beyond 110 years.
    • “Supercentenarians, a rare group of people older than 110, are tracked and their ages validated by an international nonprofit known as the Gerontology Research Group. Two hundred or so are alive today, the eldest now being a 116-year-old British woman.”
  • Per Radiology Business,
    • “One New York organization recently detailed how it was able to more than double the number of eligible patients who complete lung cancer screenings. 
    • “Over a decade after the U.S. Preventive Services Task Force (USPSTF) recommended lung cancer screening (LCS) in high-risk individuals via low-dose CT scans, utilization of the exam has continued to lag. Less than 20% of eligible patients in the U.S. adhere to LCS recommendations, despite numerous studies highlighting the exam’s ability to spot cancer at its earliest stages. 
    • “A group of providers from the University of Rochester Medical Center (URMC) were able to overcome this statistic, increasing their organization’s LCS rates from 33% in 2022 to 72% in 2025, sharing their findings in the New England Journal of Medicine Catalyst.   
    • “Our biggest success was not only screening a high percentage of eligible patients, but also enrolling those patients in the comprehensive program to ensure they receive the necessary annual follow-up screenings,” noted lead author Robert Fortuna, MD, MPH, professor of primary care and pediatrics at URMC.”

From the U.S. healthcare business front,

  • Beckers Clinical Leadership reports,
    • “Productivity, rather than quality, is gaining prominence in physician bonus structures, according to a recent report from recruiting firm AMN Healthcare. 
    • “Last year, 62% of physician contracts featured a production bonus, the report found. That figure has grown to 66%. In comparison, 16% of contracts included a quality metric in its bonus structure, down from 26% in 2024 and 31% in 2023. 
    • “Productivity metrics include relative value units, net collections, gross billings and patient encounters. Quality ranges from patient satisfaction scores to readmission rates, according to the report. 
    • “Despite initiatives “to steer physician payments toward quality metrics and away from volume-based formulas,” according to the report, “finding the right compensation formula … has been elusive.”
    • “Other industry reports have found a similar trend, with base salary and work RVU productivity remaining the most common aspect of physician compensation plans.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical introduced a pay-per-visit telehealth service for common pediatric conditions like pink eye, skin rashes and asthma prescription medication renewals.
    • “The service offers parents and guardians virtual consultations and expert medical advice for select children’s care needs, Amazon executives said in a blog post.
    • “The telehealth service, available for children ages 2 to 11, can help treat pink eye, lice and more than 10 common skin-related issues such as eczema; bug bites; contact dermatitis; impetigo; fungal rashes (e.g., ringworm); hand, foot and mouth disease; fifth disease; roseola; poison ivy; and diaper rash. This service also covers EpiPen and asthma medication renewals. For any prescriptions that are needed, customers can fulfill those orders through Amazon Pharmacy or the pharmacy of their choice. 
    • “Message-based visits start at $29, and video consultations cost $49. Insurance, Prime memberships or Amazon One Medical memberships are not required to use the service.”
  • and
    • “With the launch of its first direct-to-patient (DTP) program, Genentech is joining the wave of drugmakers setting up direct-to-consumer sales of popular products at steep discounts for cash-paying patients.
    • “The Roche subsidiary’s inaugural DTP program will center on Xofluza, its prescription influenza treatment, according to Thursday’s announcement. The single-dose oral antiviral med will be available to eligible uninsured, underinsured and self-pay patients for $50, down about 70% from its list price, per Genentech.
    • “The program will fulfill Xofluza prescriptions via partnerships with a trio of online pharmacies: Alto Pharmacy, Amazon Pharmacy and Mark Cuban Cost Plus Drug Company. Same-day delivery will be available in some U.S. markets through Alto Pharmacy and Amazon Pharmacy.
    • “The new DTC approach to Xofluza sales “will allow us to reach more patients where they are increasingly interested in seeking their medicines,” Genentech CEO Ashley Magargee said in the announcement.”

Midweek report

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

From Washington, DC

  • SHOCKER — STAT News reports,
    • “The Centers for Medicare and Medicaid Services [CMS)] is pausing Medicare payments to doctors, as negotiations tied to the government shutdown drag on. 
    • “CMS announced the pause in a notice on its website but didn’t say when it would end. It’s happening because Congress needs to reauthorize certain Medicare payment programs related to telehealth and rural providers, and that reauthorization has gotten wrapped up in the overall deal to reopen the government.
    • It’s not clear why all physician payments have been cut off rather than just the programs that need to be renewed. CMS did not immediately respond to a request for comment.
    • “An extended payment pause could eventually cause cash flow concerns for doctors, several groups representing providers told STAT — and there are fears that, in some cases, claims could be left unpaid, should the renewal of programs that have lapsed not be made retroactive. Payments for ground ambulance transport services and Federally Qualified Health Centers are also in limbo.
    • “The paused payments include those going back to Oct. 1, when the government shutdown started and several health care programs lapsed.” 
  • WHIPLASH (again from STAT News) — The Centers for Medicare and Medicaid Services said late last night that it was not pausing all Medicare payments to doctors, after a statement hours earlier had asserted that it would. Instead, the agency will only wait to process claims that are related to programs that have expired, such as some telehealth or rural services. 
  • Per the Senate press gallery,
    • “2:55 p.m. October 15 — By a vote of 51-44, the Senate did not invoke cloture on the motion to proceed to H.R. 5371, [the House passed continuing resolution] upon reconsideration.
    • “Democrats voting in favor: Cortez Masto and Fetterman.
    • “Independent voting in favor: King.
    • “Republican voting against: Paul.
    • “Senators not voting: Blackburn, Duckworth, Hagerty, Marshall and Tillis.”
  • Beckers Hospital Review offers four notes on the extension of the government shutdown into a third week.
  • Govexec adds,
    • “More than 150 lawmakers, led by Sens. Tim Kaine, D-Va., Chris Van Hollen, D-Md., and Lisa Murkowski, R-Alaska, on Wednesday demanded that the Trump administration guarantee that furloughed federal employees are granted backpay at the conclusion of the ongoing federal government shutdown, which has entered its third week.
    • “Last week, the Office of Management and Budget floated a theory that the 2019 Government Employees Fair Treatment Act, which automatically provides backpay to furloughed federal workers following appropriations lapses and was signed by President Trump during the 2018-2019 partial government shutdown, merely authorizes Congress to provide backpay after a shutdown. OMB revised its shutdown FAQ document to remove reference to the law’s guarantee, and the Internal Revenue Service revoked shutdown guidance to employees, issued just days prior, that made reference to backpay.” * * *
    • In their letter to [OMB Director Russell] Vought, the lawmakers insinuated that OMB’s stance may be more motivated by politics than a good-faith legal analysis and urged the White House to reaffirm furloughed workers’ right to backpay.
  • OPM has released a description of Federal Benefits Open Season Highlights 2026 Plan Year, which identifies the plans and plan options withdrawing from the FEHBP, the PSHBP and FEDVIP for the 2026 plan year. The as yet unreleased OPM benefit administration letter on program changes also identifies the plans with service area changes, for example.
  • The American Hospital Association News tells us,
    • “Medicare open enrollment for 2026 began Oct. 15 and runs through Dec. 7. During the annual enrollment period, Medicare-eligible individuals can check their status, choose plans or change plans during the open enrollment period, including switching from Medicare Advantage and prescription drug plans to Traditional Medicare. The Centers for Medicare & Medicaid Services projects the average monthly premium for MA plans will fall by $2.40 in 2026 to $14.00, while the average standalone monthly total premium for a Medicare Part D prescription drug plan will fall by $3.81 to $34.50. Among other changes this year, out-of-pocket costs for prescription drugs will be capped at $2,100.”
  • CMS reminds us,
    • “Medicare’s Open Enrollment Period is here! Visit Medicare.gov/plan-compare now through December 7 to compare all your coverage options. 
    • “Even if you’re happy with your current plan, it’s important to check for any changes next year. You can also check the star ratings to compare the quality of different health and drug plans.”
  • The Wall Street Journal alerts us that “Big changes Are coming for 2026 Medicare Plans. What You Need to Know. Skinnier benefits, higher premiums and fewer options mean more than a million seniors should shop for new coverage during open enrollment.”
  • Healthcare Dive reports,
    • “CMS Administrator Dr. Mehmet Oz highlighted areas where Medicare Advantage could improve — while reaffirming his support for the privatized Medicare program — during an event organized by the top MA lobby on Wednesday.
    • “Oz’s comments reflect the difficult tightrope regulators in the Trump administration walk as they pursue MA reform, especially in the areas of improper overpayments and prior authorizations, without offending the powerful insurance industry.
    • “I came both to celebrate what you’re trying to do, but also be honest about some of the issues that we’re seeing at CMS,” Oz said during the Better Medicare Alliance’s forum in Washington, D.C. “The opportunities we have if we do this correctly are massive. I see Medicare Advantage as this essential lever arm, this tool that we can use for good — and sometimes not — but if we use it correctly and nimbly, we can do all kinds of things to refine and improve the system.”
  • Medscape notes,
    • “Enrollment in Medicare Advantage was associated with an increased likelihood of receiving an Annual Wellness Visit, especially among racial and ethnic minorities, those with dual eligibility, and those with Alzheimer’s disease and related dementias.”
  • Per Fierce Healthcare,
    • “Fifteen governors unveiled Wednesday a new coalition to coordinate public health efforts in the latest sign of distrust in federal health agencies.
    • “The so-called Governors Public Health Alliance is now the largest alternative public health authority run by states, with leaders representing 129 million Americans, and follows the three-state West Coast Health Alliance and the 10-state Northeast Public Health Collaborative. The new effort is described as complementary to the states’ existing public health mechanisms and in line with the two existing coalitions.
    • “Announcements from several of the governors describe the effort as nonpartisan, though all the current participating leaders are Democrats. The alliance itself is supported by GovAct, a nonprofit and nonpartisan platform for gubernatorial collaborations.
    • “Similar to other states’ efforts, the governors said their new alliance will share best practices and expertise, coordinate on disease surveillance, co-draft public health guidelines and purchase supplies such as vaccines. It will also keep an open dialogue with the global health community while “elevating national considerations for vaccine procurement, policy solutions and more,” according to announcements.”

From the judicial front,

  • The Wall Street Journal relates,
    • “A federal judge temporarily blocked the Trump administration from moving ahead with mass firings of federal employees while the government is shut down. 
    • “Judge Susan Illston issued the temporary restraining order in a ruling from the bench on Wednesday, stopping the government from cutting federal workers at multiple agencies. 
    • “The court record suggested that the Trump administration has “taken advantage of the lapse in government spending and government functioning to assume that all bets are off, that the laws don’t apply to them anymore and that they can impose the structures that they like on the government situation that they don’t like,” said Illston, a Bill Clinton appointee. 
    • “The Trump administration moved ahead on threats last week to lay off federal workers, sending reductions in force notices, otherwise known as RIFs, to about 4,000 employees at more than a half-dozen federal agencies, including the departments of Treasury, Health and Human Services, Education and Commerce.”
  • Healthcare Dive informs us,
    • “A federal judge has thrown out a last-ditch effort from Humana to get the government to recalculate its Medicare Advantage star ratings for 2025.
    • “On Tuesday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS acted legally in downgrading Humana’s stars based on unsuccessful customer service calls.
    • “O’Connor dismissed the case with prejudice, meaning it can’t be refiled but could still be appealed. A spokesperson for Humana said the company is “disappointed” with the ruling and is considering “all available legal options.”
  • Sequoia explains how to navigate the legal landscape of gender-affirming care in employer health plans.

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP points out,
    • “A new update from the South Carolina Department of Health (SCDH) says the state’s measles outbreak has grown by 5 cases, to 16 infections since July, including 12 cases that are part of an Upstate outbreak that has seen two schools send hundreds of unvaccinated kids home after exposure to the highly contagious virus.
    • “The cases come as the US total climbs to 1,596 confirmed infections.”
  • Medscape discusses a new COVID variant known as Frankenstein.
    • “According to the World Health Organization (WHO), this rise is associated with the emergence of a new SARS-CoV-2 variant, XFG, also referred to as “Frankenstein,” because it is a recombinant of two other variants, LF.7 and LP.8.1.2.
    • “XFG has been classified by the WHO as a variant under monitoring since 25 June 2025 and is growing globally. Current evidence suggests that the additional public health risk is low worldwide, and approved COVID vaccines are expected to remain effective against this variant to prevent symptomatic and severe disease.”
  • The Washington Post lets us know,
    • “Health officials in New York state confirmed the first locally acquired case of chikungunya in the United States in six years. The virus is rarely fatal, and most patients recover in a week, but in some cases, it can cause prolonged and debilitating joint pain.
    • “It is also the first locally acquired case of chikungunya in New York, the state’s health department said. A resident of Nassau County, who was not named, had not reported any foreign travel before experiencing symptoms in early August, the county’s health department said. County officials said on Tuesday they had not found chikungunya in local mosquitoes, adding: “There is no evidence of ongoing transmission of the virus and the risk to the general public remains low.”
  • Per Healio,
    • “Alcohol-induced deaths increased by 89% from 1999 to 2024, peaking in 2021.
    • “These deaths rose by 255% among women aged 25 to 34 years and by 188% among men aged 25 to 34 years.”
  • and
    • “Mean BMI increased for premenopausal women and postmenopausal women in the U.S. from 1999 to 2018.
    • “The 50th percentile BMI for premenopausal and postmenopausal women peaked at about age 60 years.”
  • Per Medscape,
    • “Egg- and non-egg-based influenza vaccines showed equivalent protection against laboratory-confirmed influenza‑like illness and related hospitalizations among healthy adults in the military health system. However, recombinant influenza vaccine achieved higher seroconversion rates across all influenza subtypes.”
  • and
    • “Penicillin V was as effective as amoxicillin for treating pneumonia in primary care, with similar rates of hospitalization for lower respiratory tract infection or all-cause mortality within 28 days of starting antibiotic therapy, making it a viable alternative in primary care settings with similar resistance patterns.”
  • Per Fierce Pharma,
    • “GSK’s ViiV Healthcare and its bimonthly pre-exposure prophylaxis (PrEP) medicine Apretude had to make room for another long-acting PrEP option this summer, when rival Gilead Sciences rolled out Yeztugo to much fanfare.
    • “But despite Yeztugo’s twice-yearly convenience factor, unprecedented efficacy performance in trials and award-winning pedigree, GSK has long maintained that one aspect of the rival drug’s clinical profile would block it from snatching the entire long-acting PrEP market.
    • “Now, armed with a new open-label crossover study, the company can back up its theory that the injection-site reactions from Gilead’s drug may give some potential users pause.
  • Per BioPharma Dive,
    • “Eli Lilly released the results of two new Phase 3 trials of an experimental GLP-1 pill that the company says could become a “foundational treatment” for type 2 diabetes.
    • “The medicine, orforglipron, succeeded on all primary and key secondary endpoints in the studies of diabetes patients, Lilly said Wednesday. One trial, Achieve-2, compared orforglipron with dapagliflozin, sold by AstraZeneca as Farxiga. The other, Achieve-5, tested orforglipron against a placebo in patients also taking insulin.
    • “The Indianapolis-based drugmaker plans to submit global regulatory applications for orforglipron in the treatment of type 2 diabetes next year. The company said it will seek approval of the drug as an obesity medication by the end of 2025.”
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and American Society of Health-System Pharmacists.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health and the University of Pittsburgh Medical Center have signed a non-binding letter of intent to integrate Steubenville, Ohio-based Trinity Health System into UPMC. 
    • “CommonSpirit and Trinity Health leaders began a search earlier this year to find a regional health system that would add to Trinity’s offerings, according to a Wednesday news release.
    • “The health systems will work toward a definitive agreement over the next several months.” 
       
  • Healthcare Dive informs us,
    • “CVS has completed a deal to buy 63 Rite Aid and Bartell Drugs stores in Idaho, Oregon and Washington. As part of the deal, which comes five months after Rite Aid filed for bankruptcy, CVS will also acquire the customer prescription files of 626 locations across 15 states.
    • “The agreement was first announced in May, though CVS at that time planned to acquire 64 locations and 625 prescription files. The transfer of assets was approved by a bankruptcy judge later that month.
    • “CVS is also bringing on more than 3,500 employees from the defunct chain and has made “targeted investments” in existing CVS locations to meet the needs of new shoppers. That includes adding more support and improving training programs for associates.”
  • The New York Times reports,
    • “For years, Democrats and Republicans have sounded the alarm about America’s dependence on China for medicines. An analysispublished on Wednesday shows just how deep that reliance is at the earliest stage of the drug manufacturing process: Nearly 700 U.S. medicines use at least one chemical solely sourced from China.
    • “As tensions between Washington and Beijing have escalated in recent years, experts fear that this reliance could leave American patients vulnerable, especially if a trade war or future pandemic prompts China to curtail exports. Supply shortages for some generic medicines have already grown common.
    • “The new data, from U.S. Pharmacopeia, a nonprofit that tracks the drug supply, identified the origins of chemicals used to make medicines. The analysis found that China was the sole supplier of at least one chemical in widely used antibiotics, like amoxicillin, and generic drugs for heart problems, seizures, cancer and H.I.V.
    • “One example is the allergy-relief medicine best known by the brand name Benadryl. (Kenvue, the company that sells Benadryl, did not return a request for comment.)
    • “There is almost no production of these chemicals in the United States because making them is dirty and labor and other costs make manufacturing them unprofitable. Chinese factories, by contrast, don’t face the same environmental restrictions and can make these raw materials inexpensively.”
  • Fierce Healthcare notes,
    • “Blue Cross Blue Shield Global Solutions is teaming with Carrot to offer family planning and fertility services to expatriate members across the world.
    • “BCBS Global Solutions, jointly owned by 15 Blue Cross plans and Bupa Global, will connect members globally with Carrot’s array of hormonal and family planning care, ranging from fertility, pregnancy, postpartum, surrogacy, adoption, menopause and low testosterone management. The organization shared the announcement exclusively with Fierce Healthcare.
    • “Through Carrot’s platform, members can access a network of more than 17,000 vetted providers worldwide, plus services that are available in more than 25 languages or through live translation across 300 languages.
    • “Following our recent rebrand, this partnership with Carrot marks another step forward in our commitment to deliver innovative global healthcare solutions,” said Simon Jackson, Chief Growth Officer of BCBS Global Solutions, in the announcement.”
  • Per Fierce Pharma,
    • “With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds.
    • “The investment will increase the capabilities of AZ’s manufacturing facility in Coppell, Texas, which is the company’s lone site in the world that produces Lokelma.
    • ‘AZ will build a new 9,000-square-foot building at the complex and add two production lines, doubling its capacity to manufacture the treatment. The investment also will support upgrades for drug substance production and lab testing, as well as additional warehouse and administrative space, the company said in an Oct. 15 release.”

From the artificial intelligence front,

  • Fierce Healthcare offers a look inside Elevance Health’s AI strategy.
    • “The pace of digital innovation in healthcare is rapidly accelerating, and, for the team at Elevance Health, a simple mantra remains at the heart of its efforts: Keep the member at the center.
    • “Ratnakar Lavu, executive vice president and chief digital information officer at Elevance, told Fierce Healthcare in an interview that the perspective is born from his experience in consumer industries like retail, where many patients form their expectations for digital experiences.
    • “Digital platforms can make things simpler and more personalized for members, he said, but there’s also a risk of deploying new tech just for the sake of it.
    • “My obsession always has been, let’s focus on the consumer, the member, and in our case, the patient, and keep them at the center of how we think about overall transformation,” he said. “Because it’s not technology for the sake of technology, it is really trying to focus on the experiences that we want to bring to life.”
  • STAT News reports,
    • “Lyra launches ‘clinical grade’ chatbot amid growing concern about mental health and AI
    • The company is the largest to launch a generative AI product as a part of ongoing therapy treatment.”
  • and
    • “As more nurses deliver primary care, an AI startup wants to guide their decisions and training> Altitude has raised $5.4 million to develop its platform and expand customer base.
  • MedTech Dive shares “five AI takeaways from AdvaMed’s conference. Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.

Tuesday’s report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Senate returned to Capitol Hill today and is scheduled to hold its eighth vote on the House-passed continuing resolution but is expected to fall short of the 60 votes required to pass the CR. Formal negotiations toward a deal still have yet to take place. The House, which has been out of session since passing the CR Sept. 19, remains out this week with no plans to return.”
  • The FEHBlog adds that today’s Senate eighth vote on the House passed continuing resolution did fall short of the 60 votes required to pass the CR. The vote was 49 ayes and 45 nays. The Majority Leader switched his vote from aye to nay to preserve his ability to bring this cloture motion back to the floor.
  • CNBC informs us,
    • “The government shutdown will delay a key announcement that affects millions of Social Security beneficiaries — just how much their benefit checks will increase in 2026.
    • “The Social Security cost-of-living adjustment for next year will be revealed once September consumer price index data, which was slated for release on Oct. 15, is available. Due to the federal government shutdown, the CPI release has been pushed to Oct. 24.
    • “The Social Security Administration (SSA) will use this release to generate and announce the 2026 cost-of-living adjustment (COLA) on October 24 as well,” a Social Security spokesperson told CNBC.com via email.” * * *
    • “Experts estimate the benefit increase may fall in the range of 2.7% to 2.8%, based on the most recent government inflation data. Such an increase would push the average retirement benefit up by about $54 per month.”
  • Fierce Healthcare relates,
    • “The Purchaser Business Group on Health is launching a massive data project that aims to make it easier for employers to get their arms around what they’re actually paying for healthcare.
    • “The organization unveiled its Health Care Data Demonstration Project on Tuesday morning, which is built on both hospital price transparency data and transparency in coverage information, establishing tools that employers can use to more accurately determine a “fair price” for healthcare services.
    • “The demonstration leans on five large employers, including aerospace company Boeing and technology firm Qualcomm, PBGH said in an announcement. Armed with more accurate pricing data, employers can see where their health plans or third-party administrators may be falling short in managing costs.”
  • WTW identifies ten “surprising expenses” that can be reimbursed from an employee’s health savings account.
  • Life Health Advisor lets us know,
    • “Equitable, a leading financial services organization and principal franchise of Equitable Holdings, Inc. (NYSE: EQH), has announced new findings from a national survey of more than 1,000 consumers, highlighting key financial trends shaping how Americans engage with their workplace benefits.
    • “The survey revealed that 80% of Americans worry that an unexpected medical expense could derail their financial goals, with more than a quarter of this group indicating that a bill under $1,000 would cause financial hardship. Younger generations are especially anxious — 89% of Gen Z and millennials said an unplanned medical cost would disrupt their financial plans, compared to just 56% of baby boomers.
    • “Since employer-sponsored health insurance often does not cover the full cost of medical care, workers frequently pay out of pocket for uncovered expenses. When respondents were asked how they would pay for a costly and unplanned medical bill, 48% said they would set up a payment plan, 31% would use general savings, and 28% would rely on credit cards. Notably, 12% would take a hardship withdrawal from their retirement account, with millennials (20%) and Gen Z (16%) more likely to do so than Gen X (6%) or baby boomers (3%).
    • “Americans’ health and wealth needs are inextricably connected. An unplanned visit to the hospital can put a person’s long-term financial security at risk — especially if they need to tap into retirement savings to cover a costly medical bill,” explained Stephanie Shields, Head of Equitable’s Employee Benefits business. “While some approach open enrollment as a chore each year, it is important to take the time to understand all the benefit options offered by your employer. This investment can protect your health and your financial well-being.”
  • Per a PCMA news release,
    • “After more than seven years leading the Pharmaceutical Care Management Association (PCMA) and in the last year of his contract with the organization, PCMA President and CEO Juan Carlos “JC” Scott today announced his decision to step down before the end of the year.
    • “JC has led PCMA during a critical period of transition in health care. He works tirelessly to advocate for the PBM industry and our mission to lower prescription costs for the patients, businesses, labor unions, health plans, and public partners we’re proud to serve,” said PCMA board chairman Adam Kautzner, PharmD, President, Evernorth Care Management & Express Scripts. “We value JC’s role in leading PCMA to where it is today during a time of dynamic changes on Capitol Hill and in the states. As we begin the search for a new head of the association, it is helpful to have JC’s continued guidance in this transition period.”

From the Food and Drug Administration front,

  • Cardiovascular Business points out,
    • “Medtronic has received an important update from the U.S. Food and Drug Administration (FDA) to the labeling of its Endurant stent graft system.
    • “Going forward, the FDA is allowing Medtronic to include clinical evidence related to the treatment of ruptured abdominal aortic aneurysm (rAAA) in the device’s labeling. In addition, Medtronic can now remove the rAAA treatment warning currently required to be included in the instructions for use (IFU) of the Endurant system and other similar devices.
    • ‘The Endurant stent graft system has been used to treat abdominal aortic aneurysms for more than a decade now. It now stands as the first and only endovascular aneurysm repair (EVAR) system to receive this labeling update from the FDA.” 
  • CNN reports,
    • “The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out.
    • “Roche Diagnostics said Monday that its Elecsys pTau181 test, developed in collaboration with Eli Lilly, could be used by primary care physicians to help identify patients who are unlikely to have Alzheimer’s disease, while those with a positive result would be recommended for further testing.
    • “The test is intended for adults 55 and older in the United States who are showing signs or symptoms of cognitive decline.”
  • Per Fierce Pharma,
    • “It appears problems at Novo Nordisk’s recently acquired manufacturing facility in Indiana aren’t going to be solved any time soon. The FDA has tagged the former Catalent facility with an official action indicated (OAI) label, which is the most severe of the three inspection classifications issued by the agency.
    • “The OAI designation—which identifies facilities that are at “an unacceptable state of compliance,” according to the regulator—is bad news for drugmakers who depend on the massive plant in Bloomington for contract manufacturing.
    • “One of those companies is Scholar Rock, which is bidding for FDA approval of its highly anticipated spinal muscular atrophy (SMA) treatment apitegromab. Another is Regeneron, which has two FDA applications pending for eye disease treatment Eylea, which is produced at the site.
    • “In an email, Novo Nordisk acknowledged receiving the OAI status notification on Oct. 9 and said it is in contact with the FDA and its CDMO partners who are affected.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “More children are getting diagnosed with autism than ever before.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. has promised to find out why. The Trump administration has already touted the active ingredient in Tylenol, acetaminophen, as a possible cause, even as doctors and researchers say the link is unproven.
    • “Autism has a strong genetic component, scientists say, and some known risk factors such as older parental age might have contributed to the increase. Some think environmental exposures that haven’t yet been identified could also have played a role. 
    • “But to explain the bulk of the rise — from one in 150 8-year-old children in 2000 to one in 31 in 2022 — many doctors and scientists point to how the diagnosis itself has morphed over time.” * * *
    • “Some researchers and advocates have started using the term “profound” autism to describe cases among children with an IQ of less than 50 or who are minimally verbal or nonverbal. Around 27% of 8-year-olds with autism in the U.S. fit that description, according to the most recent estimates. 
    • “Profound autism cases have ticked upward, but the much bigger rise has been in the children with fewer impairments. Kids referred for an autism evaluation are now less likely to have intellectual disabilities or major language delays, said Amy Esler, a psychologist and professor in the pediatrics department at the University of Minnesota.” * * *
    • “Clinicians also started screening more kids, after the American Academy of Pediatrics recommended it for all children at 18 and 24 months starting in 2007, researchers said.  
    • Rates vary based on location, with federal data from 2022 showing prevalence ranging from 9.7 per 1,000 8-year-olds in Laredo, Texas, to 53.1 per 1,000 in California.”
  • Health Day tells us,
    • “Heart rate variability biofeedback (HRVB) can reduce negative affect, craving, and substance use among individuals in early recovery from substance use disorder (SUD), according to a study published online Oct. 1 in JAMA Psychiatry.
    • “David Eddie, Ph.D., from Massachusetts General Hospital in Boston, and colleagues examined the efficacy of HRVB in the treatment of SUD. The analysis included 115 adults seeking treatment for SUD who were randomly assigned to receive treatment as usual with or without HRVB as a wearable smart patch.”
  • Cigna, writing in LinkedIn, discusses understanding subclinical mental health conditions and their impact on the workplace.
    • “Subclinical mental health conditions like mental load, daily stressors, and mild anxiety are real challenges for today’s workforce. Though less visible than clinical diagnoses, their impact on productivity, morale, and workplace culture is profound. Recent U.S. data shows these issues are common, making it essential for employers to take notice.
    • “By prioritizing mental health before problems become severe, business leaders and HR managers can create healthier, more engaged teams and a more successful organization. The steps are simple but powerful: open communication, flexibility, education, and access to support. Investing in employee well-being isn’t just about compassion; it’s about building a thriving workplace for everyone.”
  • Gastroenterology Advisor notes,
    • “Patients with ulcerative colitis (UC) and Crohn disease (CD) do not have a higher risk for colonic perforation during colonoscopy than patients without inflammatory bowel diseases (IBDs), according to study results published in Digestive Diseases and Sciences.”
  • The American Journal of Managed Care relates,
    • “A 12-year study in China finds that individuals who dine out often face a higher risk of colon and rectal cancers, with obesity playing a mediating role.
    • “Regularly eating meals away from home may carry more than just financial costs. A large cohort study of over 42,000 adults in China found that frequent dining out was significantly associated with an increased risk of colorectal cancer.1The findings suggest a dose-response relationship, with obesity emerging as a key factor that may partially mediate the link between dining habits and cancer risk.
    • “This cohort study is published in Frontiers in Oncology.
    • “Our findings indicated that over half of the Chinese adult population reported dining out at least once per week,” wrote the researchers of the study. “Furthermore, a significant association was observed between frequent dining out and an elevated risk of both colon and rectal cancers when compared to individuals who dined out rarely or never.” * * *
    • “The study found a 2.23-fold increased risk for colon cancer and a 1.79-fold increased risk for rectal cancer among frequent diners.”
    • “Obesity partially mediates the association between dining out frequency and colorectal cancer risk.”
    • “Limitations include self-reported dining frequency, potential unmeasured confounders, and lack of detailed meal data.”
  • Per a UNC Health news release,
    • “A first-of-its-kind clinical study shows that offering modest monthly grocery cards for produce leads to improvements in blood pressure compared to distributing pre-selected boxes of healthy food.
    • “While the link between nutrition and improved health outcomes is well established, there had previously been limited clinical evidence to guide how best to deliver healthy food to individuals facing food insecurity. Funded by Blue Cross and Blue Shield of North Carolina (Blue Cross NC) and conducted by researchers at UNC Health and UNC Schools of Medicine and Public Health, the Healthy Food First trial offers compelling evidence that empowering people to choose the nutritious foods they want can drive meaningful improvements in health outcomes, helping more North Carolina families take steps toward healthier lifestyles.
    • “High blood pressure affects about half of all adults and can lead to serious heart problems. Even though many people get treatment, UNC researchers say more than 75% of Americans with high blood pressure still have readings that are too high, and food insecurity can cause those numbers to go up.”
  • Per Fierce Pharma,
    • “Pfizer’s oncology portfolio has produced a second positive phase 3 trial in HER2-positive breast cancer in the span of about a year.
    • “This time, the drug that delivered the positive readout is Tukysa, a HER2-targeted tyrosine kinase inhibitor that Pfizer picked up in its $43 billion acquisition of Seagen.
    • “When used as a first-line maintenance therapy in patients with HER2-positive metastatic breast cancer who’ve responded to standard induction therapy, Tukysa significantly prolonged the time before cancer progression or death compared with placebo, Pfizer said Tuesday. Both Tukysa and placebo were given in combination with the standard maintenance regimen of Roche’s Herceptin and Perjeta.
    • “The statistically significant and clinically meaningful improvement in progression-free survival means that the phase 3 HER2CLIMB-05 trial has met its primary endpoint, Pfizer said.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are grappling with a shortage of anesthetists and reimbursement cuts, a combination of factors that could limit patient’s access to care and provider’s expansion plans. 
    • “They hope to stave off service reductions by training more CRNAs and simplifying clinician operations, but those strategies may not overcome mounting financial pressures, hospital executives and staffing experts said. Rural areas could be particularly hard hit.
    • “There is serious financial strain on the cost to keep surgery departments going right now,” said Alex Herbison, vice president of physician solutions at staffing firm AMN. “It doesn’t feel sustainable.”
  • Beckers Hospital Review informs us,
    • “CVS Health released its 2025 “Rx Report: Community Pharmacy Reimagined” Oct. 14, highlighting trends in patient expectations, workforce dynamics and technology adoption across the pharmacy sector.
    • “To devise the report, CVS surveyed more than 2,200 customers and 1,060 pharmacists and pharmacy technicians.”
    • The article offers seven takeaways from the CVS report.
  • Beckers Oncology identifies 50 “hospitals and health systems that are opening cancer centers or expanding cancer care services in 2025.”
  • Healthcare Dive reports,
    • “California Gov. Gavin Newsom signed into law new rules on Monday that will place more restrictions on corporate investors’, including private equity firms’, role in healthcare delivery.
    • “The law, Senate Bill 351, prohibits financial firms from having a hand in medical decisions, including determining how many patients clinicians see per hour or what diagnostic tests are appropriate. 
    • “The legislation was drawn up in response to a growing body of evidence that links private equity firms’ involvement in healthcare to higher costs, lower care quality and reduced services, according to the California Medical Association, which backed the bill.” 
  • The Wall Street Journal relates,
    • “Johnson & Johnson plans to separate its artificial hip and knee business into a stand-alone company to be called DePuy Synthes.
    • “J&J said it expects to complete the separation within 18 to 24 months.
    • “This separation is part of J&J’s strategy to focus on higher-growth and higher-margin businesses.”
  • Per BioPharma Dive,
    • “Obesity startup Kailera Therapeutics has raised one of the year’s largest private funding rounds, securing $600 million to support global, late-stage testing of an injectable drug that works similarly to Eli Lilly’s Zepbound.
    • “Bain Capital Private Equity led the Series B round, which also involved Adage Capital Management, investment funds from the Canadian and Qatari governments, Royalty Pharma and other investors. Multiple so-called crossover investors that back private and public drug companies participated, too. 
    • “Kailera and its partner Hengrui Pharma reported in July that the drug, called KAI-9531 or HRS9531, helped people with obesity lose 18% of their body weight on average in a 48-week Phase 3 trial in China, positioning the company to seek approval there. The Food and Drug Administration will likely require a larger, longer, multi-country study before considering a U.S. clearance.”
  • Per Fierce Healthcare,
    • “Oura, the company behind the personal health tracker the Oura Ring, has raised more than $900 million in series E funding, reflecting the company’s rocketing revenue and sales over the last year. 
    • “The company is now worth $11 billion. 
    • “In 2025, Oura Rings soared in sales. The preventive health company has sold 5.5 million smart rings since 2015, and nearly 3 million of those sales occurred in 2025. Its total sales for the year are expected to reach $1 billion between the devices and app subscriptions, according to the company.
    • “The Oura Ring and corresponding app track health metrics like sleep, fertility windows, heart rate, activity and movement and metabolic health.” 
  • and
    • “Digital health platform Hello Heart is launching a new suite of medication management tools for people at risk of heart disease, including an AI assistant for heart health.
    • “Through a connected blood pressure monitor and app, patients can track their blood pressure, cholesterol and medications. Hello Heart aims to reduce the cost of cardiovascular conditions, which, if left untreated, result in costly hospitalizations. Nearly half of the U.S. adult population has hypertension.
    • “The new suite of tools aims to help patients take their medications and manage side effects. It has three components: Nia, an AI assistant; a connected pill box; and chart reviews of high-risk members’ health records by pharmacists.
    • “Medication is the best way to treat high blood pressure, a major risk factor for heart conditions, Edo Paz, M.D., senior vice president of medical affairs at Hello Heart, said in an interview. However, many patients struggle to remember to take their medication or discontinue medications because they don’t perceive a benefit.”
  • Per Fierce BioTech,
    • “Having already established a commercial infrastructure for its oral hereditary angioedema (HAE) drug Orladeyo and eager to pinpoint the source of its future growth, BioCryst Pharmaceuticals has struck a $700 million deal to buy Astria Therapeutics. 
    • “The deal will give the rare disease specialist control of a phase 3 challenger to Takeda’s HAE therapy Takhzyro.
    • “North Carolina-based BioCryst already sells the daily oral capsule Orladeyo, which won approval in 2020 to prevent HAE attacks in patients 12 and older. Forecasting that Orladeyo sales will peak at $1 billion around the end of the decade, the company has been investing in drug discovery and scouting around for deals to drive its next phase of growth.”
  • Per MedTech Dive,
    • Medtronic said Wednesday [October 9] it has completed the first procedures in a U.S. clinical study assessing the safety and effectiveness of its Hugo robot in gynecological procedures.
    • Gynecology is the focus of Medtronic’s third investigational device exemption study in the U.S., after trials for urology and hernia repair met their primary safety and effectiveness endpoints.
    • The total hysterectomy procedures were performed at AHN West Penn Hospital in Pittsburgh. Medtronic expects to enroll as many as 70 people across up to five U.S. hospitals, and include patients having radical, modified radical or total hysterectomies, as well as those being treated for malignancies.

Friday report

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

From Washington DC,

  • Here is a link to today’s Secrets of OPM blog post by OPM Director Scott Kupor.
  • Here are links to Fedweek and Fedsmith articles about OPM’s 2026 government contribution announcement made yesterday.
  • Yesterday, the FEHBlog posted the Internal Revenues Service’s 2026 inflation adjusted amounts.
    • The Wall Street Journal discusses how the adjustments impact federal income taxation.
    • Newfront discusses how the adjustments impact employee benefits.
  • Healthcare Dive notes,
    • “Average Medicare Advantage star ratings for 2026 are essentially flat after a few consecutive years of declines — a good sign for the industry, which had braced itself for lower quality scores.
    • “Still, there was variation in major insurers’ results. The percentage of members in plans rated 4 stars or above, an important cutoff for payers, stayed stable for UnitedHealthcare, dropped for Humana and Aetna, and improved for Elevance and Centene — the five largest publicly traded payers in the privatized Medicare program.
    • “Perhaps the biggest loser is Clover Health. The insurer’s largest contract covering almost all of its MA members dropped below 4 stars — a slip that could cost Clover tens of millions of dollars in earnings, analysts estimate.”
  • The American Hospital Association News tells us,
    • “The federal government shutdown is expected to continue into next week as the Senate adjourned Oct. 9 after failing to pass spending legislation; senators plan to return Oct. 14. Meanwhile, the House currently has no plans to return to session next week. The Senate Oct. 9 failed to adopt the House-passed continuing resolution to fund the government following a seventh vote on the bill. Senate Republicans and Democrats have yet to begin formal negotiations toward a deal.”
  • Federal News Network points out,
    • “Hundreds of thousands of federal employees are set to receive reduced paychecks, now on day 10 of the partial government shutdown.
    • “While most civilian federal employees are expected to get their paychecks sometime in the next couple days, they’ll only take home the pay they earned up until the shutdown began. Regardless of whether they are excepted or furloughed, federal employees will not be paid for any days worked between Oct. 1 and Oct. 4 — the final few days of the most recent two-week pay period.
    • “With the partial paychecks, many federal employees will lose out on hundreds of dollars. The exact timing of when employees receive their paychecks depends on their agency, but many began going out Friday.
    • “It’s also the last paycheck excepted and furloughed employees will receive until the government shutdown ends. The first fully missed paycheck, if the shutdown continues, will be for the pay period of Oct. 5 through Oct. 18. Only federal employees who are considered “exempt” from the shutdown will continue to be paid as usual.”
  • Roll Call reports,
    • ​”The Trump administration made good on its threat to begin mass firings of federal civilian employees Friday while exploring creative avenues to make sure military personnel don’t miss their paychecks slotted to go out next week.
    • “With no end in sight to the partial government shutdown that began 10 days ago, White House budget director Russ Vought announced on X that he has begun executing mass layoffs across federal agencies.
    • “An Office of Management and Budget official said the layoffs are “substantial,” without elaborating. Details began trickling out ahead of a court-ordered deadline by close of business Friday, however, hitting numerous agencies including Treasury, EPA, Homeland Security, Education, and Housing and Urban Development, among others.
    • “Speaker Mike Johnson, R-La., meanwhile, officially canceled votes in the House next week, meaning there is virtually no chance that Congress could pass a stand-alone bill to provide pay to some 2 million troops whose next paycheck is due Oct. 15.
    • “But in keeping with President Donald Trump’s pledges to “take care of” the military while punishing “Democrat agencies,” his administration is looking at how to make sure the troops are kept whole financially. A senior White House official said the administration is “exploring every legal maneuver and option at our disposal to get our troops paid during the Democrat Shutdown.” 
  • STAT News informs us,
    • “The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants. 
    • “The BIOSECURE Act, which was passed as an amendment to the National Defense Authorization Act, has been a long time coming. A more aggressive version of the bill was introduced in the Senate in December 2023. The House proposed similar legislation the next month.
    • “BIOSECURE is not over the finish line yet, but it’s significant that the Senate included it in the National Defense Authorization Act, because the defense budget bill has passed every year for decades. The House passed its version of the defense bill earlier in the year without the BIOSECURE Act, so the two chambers would need to agree to include BIOSECURE in the final version of the defense budget bill when reconciling differences between their versions of it.”
  • The AHA News adds,
    • “The AHA discussed ways hospitals and health systems are leveraging artificial intelligence for care delivery in a statement submitted to the Senate Committee on Health, Education, Labor and Pensions for a hearing held Oct. 9 titled, “AI’s Potential to Support Patients, Workers, Children, and Families.” The AHA highlighted examples of AI applications in hospitals, such as diagnostic imaging, ambient listening tools and scheduling for patients and staff.
    • “Hospitals recognize that AI tools hold tremendous promise to alleviate administrative burden and enhance clinical care,” the AHA wrote. “Among other benefits, these innovations can improve workflow, enhance the overall patient experience by reducing wait times and support timely medical interventions.”
    • “The AHA also discussed potential risks of AI in health care, such as commercial insurers using it to determine disposition of claims and prior authorizations, which has exacerbated inappropriate denials. The AHA advocated for the use of clinicians to independently review care recommendations.”
  • The University of Minnesota’s CIDRAP relates,
    • “A federal vaccine advisory group has established a panel to review the safety and efficacy of the childhood immunization schedule, according to a document posted yesterday on the Centers for Disease Control and Prevention (CDC) website.
    • “The Childhood and Adolescent Immunization Schedule Workgroup (WG), established within the CDC’s Advisory Committee on Immunization Practices (ACIP), will review data and “clinical and scientific knowledge” and present its findings to help ACIP members make policy recommendations. 
    • “As part of ACIP’s core mission to develop recommendations on the use of vaccines in the civilian population of the United States, the committee is standing up a WG focused on assessing the safety and effectiveness of the childhood and adolescent schedule,” the document states.
    • “Among the topics the group will review are the timing and order of different childhood vaccines, administering different vaccines at the same time, the safety of certain vaccine ingredients, and the different childhood vaccine schedules used in other countries.”

From the Food and Drug Administration front,

  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved another new treatment option for heart-failure related edema. 
    • “Just weeks after its approval of bumetanide nasal spray for the treating edema associated with congestive heart failure, kidney disease and liver disease, the agency has given the greenlight to Lasix ONYU, a new drug-device combination from SQ Innovation, for adult patients with chronic heart failure. 
    • “Lasix ONYU provides patients with injections of a high-concentration formulation of furosemide. The injections are delivered with a small two-in-one device. While the base of the device is reusable, only to be replaced after 48 treatments, the other part of the device is used once and then discarded. According to SQ Innovation, this new-look design helps ensure the delivery device can be manufactured at a low enough price point so the treatment remains affordable.
    • “In one recent analysis published in European Heart Journal – Cardiovascular Pharmacotherapy, researchers found that the Lasix ONYU technology was linked to a bioavailability similar to receiving furosemide through an IV. Treatment was also confirmed to be “feasible and well tolerated.”

From the. public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention is not updating its respiratory illnesses data channel during the shutdown.
  • Dr. Tom Friden, a former CDC Director, writes in the Wall Street Journal about the simple steps that can prevent dementia.
    • “When it comes to healthy aging, personal responsibility matters. But American healthcare also suffers from systemic failures. Despite spending more than $4 trillion annually, we get the most important things, such as blood pressure control, right at most half the time. Our system doesn’t incentivize doctors to deliver the preventive care that matters most. For instance, they are paid little or nothing for making an effort to control a patient’s blood pressure.
    • “The tools for a healthy, dementia-free future exist: blood pressure control, appropriate statin and other therapy, smoking prevention and cessation support, and comprehensive primary care focused on prevention. We need a healthcare system that delivers them reliably, for all our sakes.”
  • Per Health Day,
    • “Heart-related health problems might affect as many as 1 in 7 pregnancies, even among women without any prior heart disease, a new study says.
    • “Researchers found a steady increase in heart-related health problems among more than 56,000 pregnancies between 2001 and 2019 in New England.
    • “Heart attack, stroke, heart failure, blood clots, high blood pressure and heart-related maternal death affected about 15% of pregnancies during that time, researchers reported Oct. 6 in the journal Circulation.
    • “Our findings showcase an alarming trend of rising real-world burden of pregnancy-related cardiovascular complications and highlights pregnancy from preconception to the postpartum period as a crucial window of opportunity to implement primary prevention strategies and optimize cardiovascular health,” concluded a team led by Dr. Emily Lau, a cardiologist at Massachusetts General Hospital in Boston.”
  • Per MedPage Today,
    • “New-onset atrial fibrillation (Afib or AF) was surprisingly common after coronary artery bypass grafting (CABG), but its burden quickly diminished to near zero after 30 days, according to long-term continuous ECG monitoring data.
    • “With a monitor implanted during surgery, patients at two German centers showed a 48% incidence of new-onset Afib in the first year after CABG, with a median Afib burden of 0.07% (or 370 minutes).
    • “It turned out that on days 1-7, the median Afib burden was 3.65% (368 minutes), dropping quickly thereafter to 0.04% (13 minutes) on days 8-30 and 0% (0 minutes) on days 31-365, according to researchers led by Florian Herrmann, MD, of LMU University Hospital in Munich, Germany.
    • “Although the incidence of new-onset AF after CABG in this study was higher than previously reported, the AF burden in these patients was very low, especially after 30 days,” the authors reported in JAMA.
    • “This low burden calls into question whether long-term oral anticoagulation is necessary in patients with new-onset AF after CABG. The very low burden provides a likely explanation for why observational studies have failed to demonstrate reduced stroke rates with oral anticoagulation in this patient group,” Herrmann’s group suggested.”
  • Per the American Journal of Managed Care,
    • “A smartphone app significantly reduced depressive symptoms and improved self-esteem and quality of life in individuals with intellectual disabilities.
    • “The study addressed a research gap, highlighting the app’s potential as an accessible mental health intervention for an underserved population.
    • “Limitations include self-reported data, potential bias, and lack of long-term follow-up, affecting the generalizability of results.
    • “Future research should explore optimal app use, caregiver involvement, and accessibility barriers to enhance mental health support for individuals with IDs.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca is the latest major drugmaker to agree to a deal with the Trump administration on lowering the prices of its drugs, some of which will be available for purchase through a government website next year, President Trump said Friday. 
    • “The agreement, which entails offering “most-favored nation” drug pricing, follows Pfizer’s deal to reduce prices for its drugs sold in the Medicaid program and through a new direct-purchasing service to be branded TrumpRx.
    • “AstraZeneca will similarly offer all prescription drugs on the government website, TrumpRx, which the administration said it will launch in 2026, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.
    • “In addition to the lower drug prices for people on Medicaid, all new AstraZeneca drugs introduced to the market will be launched at most-favored nation pricing, which is tied to comparable prices in other wealthy nations.” 
  • Reuters adds,
    • “Retail pharmacies and prescription drug savings site GoodRx (GDRX.O)
      are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies’ direct discounts.” * * *
    • “The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco (COST.O), said they were also talking with administration officials.”
  • The Wall Street Journal also lets us know,
    • “Johnson & Johnson JNJ is in talks to buy Protagonist Therapeutics in a deal that would solidify the companies’ existing partnership, according to people familiar with the matter.
    • “A deal is not guaranteed and the exact details being discussed couldn’t be learned, the people said. 
    • “Protagonist had a market value of over $4 billion as of Thursday’s close. Including a typical premium, a deal would likely value the company well above that. 
    • “”J&J is already working with Protagonist to develop an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis and has the exclusive rights to commercialize the product. It already owns close to 4% of Protagonist’s shares, according to FactSet.
    • “By acquiring Protagonist, the healthcare conglomerate would also gain access to the drug rusfertide, from Protagonist and partner Takeda Pharmaceutical4502 -2.63%decrease; red down pointing triangle. Rusfertide has shown promise in late-stage testing in treating a rare blood cancer called polycythemia vera. 
    • “Both assets would complement J&J’s portfolio of immune and cancer drugs.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is joining big pharma’s rush into “in vivo” cell therapies, paying $1.5 billion to acquire Orbital Therapeutics for a technology designed to rewire the immune systems of people with inflammatory conditions.
    • “The deal announced Friday gives Bristol Myers ownership of a company that’s been working on ways to genetically modify immune cells inside the body. Orbital’s lead program, OTX-201, does so by sending into cells “circular” RNA instructions training them to seek out cells with a particular protein flag. OTX-201, which is envisioned as an autoimmune disease treatment, could begin human testing next year.
    • “The acquisition expands Bristol Myers’ presence in cell therapies. The company is already one of the field’s leaders, with multiple marketed medicines for blood cancers. But, like its peers, Bristol views autoimmune disorders as a way to potentially broaden use of the complex treatments.”
  • Per MedTech Dive,
    • “Zimmer Biomet has launched two orthopedic devices with Paragon 28, the foot and ankle specialist it bought for $1.1 billion early this year. 
    • “The new products, which Zimmer reported Wednesday, add treatments for a type of shinbone break and hindfoot injuries to the company’s portfolio.
    • “Introducing the devices continues Zimmer’s efforts to maintain Paragon’s double-digit growth and expand its sports medicine, extremities and trauma (SET) business.”
  • The Employee Benefits Research Institute released its 2025 Employer Mental Health Survey.
  • Fierce Healthcare adds,
    • “Most employers offer coverage for mental health services, but where they fall short is in tracking whether those benefits are working, according to a new survey.
    • “The report, conducted by the Employee Benefit Research Institute (EBRI), found that 97% of employers offer mental health coverage and 67% offer coverage for substance abuse treatment. However, only 22% said they actively monitor whether employees are using the benefits.
    • “In addition, there is a significant opportunity for employers to do more in tracking network adequacy, the study found. Forty-seven percent of those surveyed said they receive details from vendors or collect data on provider-to-enrollee ratios, while 44% said they track employees’ distance to providers and 48% said they monitor wait times.
    • “Fewer than one-third (31%) said they collect data on out-of-network care use, which is a major barrier to behavioral health access, per the report.”
  • KFF-Peterson Health System Tracker studies “how much do people with employer plans spend out-of-pocket on cost-sharing?”
    • “By cost-sharing type, average spending on deductibles and coinsurance has increased, while copayments have remained flat relative to inflation since 2013. However, since 2021, inflation (16%) and spending on deductibles (13%) have grown at similar rates. Deductibles rose rapidly before 2019, however starting in about 2019 employers have held deductibles constant.
    • “In 2023, 66% of people with employer coverage spent at least $100 on out-of-pocket health care expenses. Among them, 39.7% spent between $100 and $999 on average, while 26% spent $1,000 or more. Over time, the share of enrollees facing over $1,000 in annual out-of-pocket costs has steadily increased.  Conversely, 18% of people with employer coverage incurred no out-of-pocket costs, and 15.4% spent less than $100 in 2023.
    • “Regarding total health spending, 56% of people with employer coverage spent $1,000 or more, including 41% who spent between $1,000 and $9,999 and 15% who spent $10,000 or more. Meanwhile, 12% of enrollees used no health care billed to their health plan in the year, which further highlights the uneven distribution of health care costs across the insured population under employer plans.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Health Economics Methods Advisory (HEMA) yesterday released its first ever Draft Report focused on the assessment of the benefits of treatment that are appropriate to consider in economic evaluation for health technology assessment (HTA) decision-making.
    • “HEMA has been convened by the leaders of three global HTA organizations to independently assess new methods and processes. The three institutions include ICER, England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC).
    • “This draft report will be open for public comment until October 30, 2025, providing a unique opportunity for all stakeholders to engage in the report development process.
    • “If you are interested in submitting a public comment on the Draft Report, visit https://hemamethods.org/our-research/.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports.
    • “As the government shutdown entered its second week, Democratic lawmakers insisted the tide is shifting toward a deal as some hard-line Republicans express support for extending health insurance subsidies, despite blanket opposition from Republican leadership to any agreement in advance of reopening the government. 
    • “Ending the standoff appears unlikely in the short term — votes aimed at doing so Wednesday yielded similar results as before, with the GOP’s continuing resolution going down for a sixth time, 54-45. The same three Democratic caucus members — Catherine Cortez Masto of Nevada, Angus King of Maine and John Fetterman of Pennsylvania — voted in favor. The Democrats’ continuing resolution was also blocked.
    • “As for the parameters of a potential deal, House Minority Leader Hakeem Jeffries, D-N.Y., once again ruled out a one-year extension of the subsidies. Democrats have called for a permanent extension of the premium tax credits but asked by reporters if a two-year extension was possible, Jeffries didn’t rule it out.”
  • The Wall Street Journal explains who currently gets subsidies in return for receiving coverage under the Affordable Care Act.
  • Because the 2019 shutdown ended due to an air traffic controller walkout, Govexec observes,
    • “The Federal Aviation Administration reported no travel delays due to staffing levels at U.S. air traffic control facilities Wednesday, following a day of some delays related to above-average absences at a handful of facilities.
    • “An FAA operational plan posted about noon Eastern Time on Wednesday, the eighth day of the federal government shutdown, showed no facilities impacted by “staffing triggers.” A day earlier, the same memo showed staffing levels affected operations at major hub airports in Phoenix and Denver, as well as a smaller airport in Burbank, California.
    • “Air traffic controllers are essential to the functioning of the nation’s air transportation system and must continue to work during a shutdown, though they are not paid while it is ongoing.
    • “The group has not yet missed a paycheck during the current lapse in federal funding. The first impact most federal employees will see on their pay will be Friday, when electronic funding transfers are made for the pay period from Sept. 24 to Oct. 7. 
    • “Because Congress has not appropriated money beyond Sept. 30, they would only receive a partial paycheck. Future paychecks would not be allocated until the government reopens.”
  • Per Fierce Healthcare,
    • “The top senator on healthcare policy is taking a hard look at the American Medical Association’s “anti-patient and anti-doctor” handling of the healthcare system’s near-ubiquitous billing and claims processing codes.
    • “Bill Cassidy, M.D., R-Louisiana, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, chastised the nation’s leading physician association for “abusing” the Current Procedural Terminology (CPT) coding system and said he will be “actively reviewing” the issue.
    • “In a letter sent Monday but made public Wednesday, he accused the AMA of “charging exorbitant fees to anyone using the CPT code set, including doctors, hospitals, health plans and health IT vendors. These fees inevitably are passed on by CPT users to patients in the form of higher healthcare costs.”
    • “The letter includes requests for the AMA to detail how it incorporates provider feedback into its process for finalizing codes, and for specific details on revenues and spending related to CPT codes.”
  • The Wall Street Journal relates,
    • “The country’s top drugmakers are set to meet in early December at the Four Seasons hotel in Georgetown with Donald Trump Jr. and senior Trump administration officials that regulate the pharmaceutical industry.
    • “The host: BlinkRx, an online prescription drug delivery company that this year installed Trump Jr. as a board member. The summit will conclude with a dinner at the Executive Branch, the exclusive new club founded by Trump Jr. and his close friends, according to people with knowledge of the event and a copy of the invitation viewed by The Wall Street Journal. 
    • “BlinkRx stands to benefit from a shake-up of how patients buy drugs after President Trump urged pharmaceutical companies to sell their medicines directly to consumers. BlinkRx helps drugmakers do exactly that with a service that promises to set up direct-to-patient sales programs in as little as three weeks. TrumpRx, a new government website set to launch in early 2026, would funnel patients to direct-sale sites.”
  • Healthcare Dive informs us,
    • “The top lobby for pharmacy benefit managers has named Adam Kautzner, the head of major PBM Express Scripts, as chair of its board.
    • “As board chair, Kautzner will oversee the Pharmaceutical Care Management Association’s strategy, including defense of the drug middlemen amid growing scrutiny of their role in rising drug costs. 
    • “The PCMA has also created a new council to represent its mid-market clients, a segment of its membership that’s been growing, the lobby said Tuesday. The council will be represented by a new seat on the PCMA’s board to be held by Jeff Park, president of drug pricing platform Waltz Health.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “More than 10 years after bringing one of the first idiopathic pulmonary fibrosis (IPF) drugs to market, Boehringer Ingelheim is freshening up its leadership in the rare lung disease space with a newly approved treatment option.
    • “Jascayd’s Oct. 7 FDA approval makes it the first new therapy for IPF in more than a decade, following in the footsteps of the company’s own Ofev and Roche’s Esbriet, which won their respective FDA nods back in 2014. Together, those two medicines make up the current therapeutic market for IPF in the U.S. 
    • “With a tolerability edge over the older treatments and proven benefits in lung function, Boehringer’s new option could “shape the future of IPF treatment,” Martin Beck, head of the company’s inflammation disease area, told Fierce Pharma in an interview.”
  • BioPharma Dive adds,
    • “Lexeo Therapeutics on Tuesday said the Food and Drug Administration appears willing to review, and potentially approve, its experimental rare disease gene therapy more quickly than previously anticipated.
    • “According to the company, the agency has “indicated openness” to an accelerated approval filing for its treatment — a gene therapy called LX2006 for the neurodegenerative condition Friedreich’s ataxia — that’s based on pooled data from ongoing studies as well as results from a planned pivotal trial.”

From the judicial front,

  • Reuters reports,
    • “A federal appeals court on Monday rejected Novo Nordisk’s (NOVOb.CO) challenge to the U.S. government’s program that gives its Medicare health insurance plan the power to negotiate lower drug prices, the latest in a barrage of lawsuits brought by drugmakers to fail.
    • “The Philadelphia-based 3rd U.S. Circuit Court of Appeals affirmed a lower court’s ruling dismissing the Danish drugmaker’s challenge to the program and the Centers for Medicare and Medicaid Services’ selection of six of its insulin products for price negotiations.
    • “A unanimous three-judge panel rejected Novo’s constitutional challenges to the program, which was part of Democratic former President Joe Biden’s Inflation Reduction Act, and said the law specifically bars courts from reviewing the drugs selected.
    • “A Novo Nordisk spokesperson said the company was assessing its options to appeal the ruling.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “Today the Centers for Disease Control and Prevention (CDC) updated its measles data for the country, showing a total of 1,563 cases in 2025, an increase in 19 cases since last week. This is the most cases seen in the United States since 2000, the year measles was officially declared eliminated. 
    • “Twenty-seven percent of cases have been in children under the age of 5, and 92% of patients are unvaccinated or have an unknown vaccination status. CDC officials have confirmed 44 outbreaks, which account for 87% of confirmed infections.”
  • and
    • “An international team of researchers today reported promising results from a phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections.
    • “The team, led by investigators from the University of Maryland (UM) School of Medicine, reported that the trivalent (three-strain) Salmonella conjugate vaccine (TSVC) produced a strong immune response, and was safe and well-tolerated, in a small group of healthy US adults. The findings from the trial were published today in Nature Medicine.
    • “The investigators say the findings are encouraging and provide a strong foundation for evaluating the vaccine in children. Typhoid fever and invasive non-typhoidal Salmonella (iNTS), which causes severe bloodstream infections, are leading causes of illness and death in children in Africa.
    • “A single vaccine that protects against both could be a game-changer for global pediatric health,” UM School of Medicine Dean Mark Gladwin, MD, said in a university press release.”
  • MedPage Today notes,
    • “Receipt of the 2024-2025 COVID-19 vaccine was associated with decreased risks of severe outcomes, according to an observational cohort study of U.S. veterans.
    • “Looking at COVID-associated outcomes in nearly 300,000 veterans at 6 months, the estimated vaccine effectiveness was 29.3% against emergency department visits, 39.2% against hospitalizations, and 64% against deaths, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “Overall, vaccine effectiveness for a composite of the three outcomes was 28.3%, with a risk difference per 10,000 people of 18.2 (95% CI 10.7-27.5), they noted in the New England Journal of Medicine.
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
  • The Washington Post lets us know how to stop the No. 1 killer of Americans long before any symptoms. Cardiovascular disease experts propose a new approach to treating heart disease, focusing on atherosclerosis prevention and early detection.
    • To improve your heart health, consider following the American Heart Association’s checklist, said Neha Pagidipati, a cardiovascular disease prevention expert with the American College of Cardiology.
    • The AHA’s “Life’s Essential 8” include:
      • Eating better. Recommendations include whole foods, lots of fruits and vegetables, lean protein, nuts, seeds, and using olive or canola oil for cooking.
      • Staying active.
      • Quitting tobacco and vaping.
      • Getting healthy sleep. For most adults, this is seven to nine hours of sleep each night.
      • Managing weight.
      • Controlling cholesterol. LDL, or “bad” cholesterol, should be 100 milligrams per deciliter or lower, Nissen said.
      • Managing blood sugar. If you have diabetes, pay attention to your hemoglobin A1C levels, which should be below 5.7 percent.
      • Managing blood pressure. For most people, blood pressure should be below 120/80, Nissen said.
  • Medscape adds,
    • “Many people with obesity have chronic pain due to joint stress and inflammation. Speaking to these patients about modifiable lifestyle factors — like diet and exercise — can help improve their pain severity and quality of life.
    • “In a new study published in the European Journal of Nutrition, patients with overweight or obesity who followed a 3-month weight-loss dietary intervention cut chronic musculoskeletal pain scores in half — independent of adiposity changes.”
  • NBC News reports,
    • “Short bursts of purposeful activity — such as walking around the block or lifting small weights — may be the best way to get in the habit of exercising. Bite-sized bits of exercise also improve heart and muscle fitness, a study published Tuesday in BMJ Sports Medicine found.
    • “Less than half of adults in the United States get enough aerobic activity and less than a quarter get the recommended amount of both aerobic and muscle-strengthening exercise. 
    • “When people are asked why they don’t exercise, the answers are almost always the same, no time and no motivation,” Miguel Ángel Rodríguez, a doctoral student in clinical research at the University of Oviedo in Spain, who led the study, said in an email.”
  • Per Health Day,
    • “Memantine improves social impairments in youth with autism spectrum disorder (ASD), according to a study published online Oct. 1 in JAMA Network Open.
    • “Gagan Joshi, M.D., from Massachusetts General Hospital in Boston, and colleagues examined the safety and efficacy of memantine for treating social impairments in youths with ASD in a 12-week placebo-controlled randomized clinical trial. The study population included 42 youths aged 8 to 17 years with ASD without intellectual disability who initiated treatment. The intention-to-treat efficacy analysis included 35 youths (16 treated with memantine and 19 with placebo).”
  • and
    • “More women are choosing to freeze their eggs, but fewer are returning to use them, according to a study published online Aug. 29 in the American Journal of Obstetrics & Gynecology.
    • “Mabel B. Lee, M.D., from the University of California, Los Angeles, and colleagues assessed national trends in planned oocyte cryopreservation, subsequent oocyte utilization, and outcomes of oocyte warming cycles. The analysis included data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (2014 to 2021).”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Medical practice network OneOncology has acquired GenesisCare USA of Florida and is relaunching the practice as SunState Medical Specialists.
    • “The deal adds more than 100 physicians, including urologists, oncologists and surgeons, at 104 clinics throughout Florida to OneOncology’s portfolio, according to a Wednesday news release.
    • “GenesisCare USA of Florida was part of GenesisCare, an Australia-based cancer treatment provider that filed for Chapter 11 bankruptcy protection in 2023. The company, which was backed by private equity firm KKR and China Resources Capital, entered the U.S. in 2020 when it acquired 21st Century Oncology.
    • “As part of bankruptcy proceedings, GenesisCare sought to restructure with about $1.7 billion in debt and separate U.S. operations from those in Australia and Europe. It emerged from the bankruptcy process in 2024 and trimmed its U.S. footprint to Florida and North Carolina markets. 
    • “OneOncology, which is majority owned by TPG Capital, said the latest Florida deal builds on the company’s previous investments in urology. It plans to invest in upgraded technology at SunState Medical and expand access to clinical services such as advanced radiation therapies and interventional radiology, according to the release.”
  • BioPharma Dive tells us,
    • “Having closed a nine-figure fundraising round, a newly launched biotechnology company hopes to rewire the immune system with drugs aimed at a special kind of nerve cell.
    • “Nilo Therapeutics debuted Wednesday, equipped with $101 million from a Series A financing that was co-led by the venture capital firms DCVC Bio, Lux Capital and The Column Group. Alexandria Venture Investments and the Gates Foundation also contributed to the round.
    • “The fresh money, according to Nilo, will go toward growing the biotech’s research and development team, advancing its preclinical drug programs, and establishing laboratories in New York City. Nilo formed through a collaboration between The Column Group and three Ivy League scientists — Charles Zuker, of Columbia University; Ruslan Medzhitov, of Yale University; and Stephen Liberles, of Harvard University.”
  • Per Fierce Healthcare
    • “As pharma giant Eli Lilly builds out its direct-to-consumer care site, LillyDirect, the company has tapped virtual primary care company HealthTap to join its small lineup of independent care providers.
    • “Consumers who come to LillyDirect in search of specific treatments or Lilly-manufactured medications, such as GLP-1s, can find educational materials on common health conditions and access recommendations for in-person or virtual care. 
    • “LillyDirect has been building out its network of independent care providers for a slew of healthcare conditions and specialities, including diabetes, obesity, cancer, dermatology, autoimmune, sleep apnea and migraine.
    • “HealthTap will be listed as a provider for treating type 1 and type 2 diabetes on the LillyDirect site.”
  • and
    • “Allara Health, a virtual women’s health provider, has expanded to all 50 states. 
    • “The provider, specializing in women’s hormonal, metabolic and reproductive health, was in 30 states at the start of the year. Alongside news of the expansion, Allara has also published clinical outcomes data that demonstrate improvements in patient health in a health impact report.
    • “The retrospective analysis included nearly 1,500 patients who either had a PCOS diagnosis or were being seen for other hormonal or metabolic care. It found that in the first nine months of care, patients with a body mass index (BMI) in the obese range (equal to or greater than 30) achieved a 5% mean BMI reduction. A 5% weight reduction is considered clinically significant, the report said.
    • “The analysis also found that after 10 months, two-thirds of prediabetic patients had normalized their A1C levels, and 77% of diabetics reduced their A1C levels out of the diabetic range. Patients with a high level of insulin resistance saw a 12% reduction in those levels.” 
  • and
    • “Amazon Pharmacy is rolling out kiosks stocked with prescription medications to help patients get their meds immediately after appointments. 
    • “The kiosks will launch across One Medical locations in Los Angeles starting December 2025. Expansion to additional One Medical offices is expected soon after. The kiosks will contain commonly prescribed meds like antibiotics, inhalers and blood pressure medications. Controlled substances and medications requiring refrigeration are not available.” 

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.”

Tuesday report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “President Donald Trump abruptly canceled his meeting with top Democratic leaders that had been planned for Thursday to search for a deal that might avert a partial government shutdown next week.”
  • The American Hospital Association News tells us,
    • ‘The Department of Homeland Security today released a proposed rule to amend the process for selecting among prospective applicants — known as registrants — for H-1B visas that are subject to statutory numerical caps. The rule would change the agency’s current process of conducting random selections to a weighted selection process. Weighted selections would be based on an individual’s wage level, with higher wage levels weighted more heavily. The rule would also apply the process to registrations subject to the regular cap and to those asserting eligibility for the H-1B advanced degree exemption. The proposal would require the use of additional wage level information, including the Occupational Employment and Wage Statistics wage level, Standard Occupational Classification code and the area of intended employment.”
  • and
    • “The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury. The product is designed to be used with ultrasound endoscopes for lung cancer biopsies. In response to the reports, Olympus has implemented an automated inspection procedure during assembly to help improve the detection of device damage, which is a step that was previously done through a visual inspection. The FDA said health care personnel treating patients with the product must ensure it is not from an affected lot.”
  • Milliman delves into why “many Medicare beneficiaries will spend less than expected to reach the IRA’s new $2,000 out-of-pocket spending limit.”
    • “Among other changes to the standard Part D benefit design, the IRA introduces a hard MOOP—once the beneficiary attains $2,000 in TrOOP costs in 2025, they are no longer responsible for any cost sharing—aligning the TrOOP more closely with the typical definition of a MOOP.5 Another important change introduced by the IRA is that cost sharing for basic Part D coverage counts toward the MOOP, even if that basic coverage is reduced by certain other payers.6 Federal regulators refer to the amount of drug cost that accumulates (or counts) toward the MOOP in Part D as “TrOOP eligible cost.”7 For enhanced plans,8 TrOOP eligible cost is based on the greater of defined standard benefit cost sharing and the actual patient out-of-pocket (including any cost-sharing subsidies), such that actual patient out-of-pocket will never be higher than TrOOP eligible costs.9 This regulatory guidance has been referred to as the “greater of” logic.
    • “This “greater of” provision is impactful because the defined standard benefit is frequently leaner (i.e., has higher cost sharing) than the benefit a beneficiary may actually have. In fact, around 90% of non-low-income (unsubsidized) beneficiaries are enrolled in plans with enhanced benefits.10 Enhanced plans generally offer fixed copays on generic tiers, either coinsurance or copays on brand tiers, and coinsurance on specialty tiers. Plans are considered “enhanced” if they are meaningfully richer than the defined standard benefit. Other plans are considered “basic” and are roughly equivalent in richness to the defined standard benefit.11
    • “The IRA’s accumulation logic means many beneficiaries who satisfy their MOOP will do so without spending $2,000 out-of-pocket—i.e., their specific MOOP will be less than their $2,000 limit in TrOOP eligible costs. Assuming enhanced benefits similar to 2024, we expect roughly half of non-low-income beneficiaries who reach MOOP will spend less than $1,200 out-of-pocket in 2025.12
    • “Most likely, the only beneficiaries who will pay the full $2,000 to satisfy their MOOPs in 2025 will be non-low-income beneficiaries who are enrolled in a plan with basic Part D coverage13 or who are in an enhanced plan but exclusively utilize drugs with cost sharing greater than or equal to what is under (i.e., leaner than) the defined standard benefit. The most common instance of the latter occurs for specialty drugs on tier 5, which are almost always subject to a coinsurance greater than or equal to the defined standard coinsurance amount. In some cases, this could also occur for non-preferred brand (tier 4) drugs, where the plan offers a coinsurance benefit (typically 40% to 50%, compared to the defined standard 25%).”
  • The HHS Inspector General released a report
    • “Congress appropriated $178 billion to HHS to provide funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19 under the Provider Relief Fund (PRF) program. HHS was responsible for initial PRF program oversight and policy decisions, and HRSA administered the PRF program.
    • “Under the PRF terms and conditions, if a patient had health insurance and sought COVID-19 treatment from an out-of-network provider that received PRF payments, the provider would not seek to collect out-of-pocket payments greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. (We refer to this as the “balance billing requirement.”)
    • “This audit assessed whether selected hospitals that received PRF payments complied with the balance billing requirement for COVID-19 inpatients.
    • “Of the 25 selected hospitals, 17 billed patients an amount that did not comply or may not have complied with the balance billing requirement. For example, one hospital billed a patient $6,000 when the patient’s insurance carrier had waived all patient cost-sharing responsibility.
    • “Hospitals stated that they were uncertain how to comply with the requirement because HRSA did not provide sufficient guidance. If HRSA developed and provided early and detailed guidance, hospitals might not have improperly billed selected patients a total of $637,035 for services provided.”
  • Per a Justice Department news release,
    • “The Justice Department’s Criminal Division today announced the expansion of its Health Care Fraud Unit’s New England Strike Force to the District of Massachusetts. This expansion brings enhanced federal enforcement resources to one of the nation’s most significant health care and life sciences hubs.
    • “The U.S. Attorney’s Office for the District of Massachusetts has a national reputation in health care enforcement and has developed a significant record of success in investigating and prosecuting health care fraud, including complex cases involving pharmaceutical and medical device companies, providers, and executives. In FY 2025 alone, working together on health care fraud enforcement, the U.S. Attorney’s Office’s Health Care Fraud Unit and Affirmative Civil Enforcement Unit recovered more than $450 million in fraudulently obtained funds. Building on the U.S. Attorney’s Office’s historic track record and the success of the Criminal Division’s Health Care Fraud Unit’s specialized prosecutors and data-driven, multi-agency Strike Force model, the Department is deploying a powerful force multiplier, allowing it to accelerate the detection, investigation, and prosecution of complex fraud schemes throughout the District of Massachusetts.”

From the public health and medical/Rx research front,

  • NBC News reports,
    • “One of the largest measles outbreaks in the U.S. is now centered in bordering areas of southwestern Utah and Arizona. 
    • “In Southwest Utah, all but one of the 23 confirmed cases are among unvaccinated, school-age kids, the Southwest Utah Public Health Department reported. In Mohave County, Arizona, which health officials believe is connected to the Utah outbreak, there have been 42 confirmed cases of the highly contagious virus.
    • “An NBC News investigation, done in collaboration with Stanford University, has found that much of the United States doesn’t have the vaccine protection to prevent outbreaks of communicable diseases such as measles.”
  • Cardiovascular Business informs us,
    • “Approximately 6.7 million Americans over the age of 20 have heart failure, according to a new data-driven analysis published by the Heart Failure Society of America (HFSA). That number is expected to rise, the group added and could hit approximately 11.4 million by 2050.
    • “Those were just some of the eye-opening statistics included in a new HFSA report published in the Journal of Cardiac Failure.[1] In addition, the group wrote, approximately one in four Americans will develop HF in their lifetime. And the odds are even greater for Black individuals than those from other racial and ethnic groups.”
  • The Washington Post points out what researchers suspect may be fueling cancer among millenials.
  • Genetic Engineering and Biotechnology News notes,
    • “Neurological disorders, such as schizophrenia and bipolar disorder, remain challenging to diagnose due to the absence of objective biomarkers. Current assessments largely rely on subjective clinical evaluations. 
    • “In a new study published in APL Bioengineering titled, “Machine Learning-Enabled Detection of Electrophysiological Signatures in iPSC-Derived Models of Schizophrenia and Bipolar Disorder,” researchers from Johns Hopkins University (JHU) present a computational analysis pipeline designed to identify disease-specific electrophysiological signatures from patient-derived cerebral organoids and two-dimensional cortical interneuron cultures. The findings may help reduce human error when diagnosing mental health disorders that currently only rely on clinical judgement.”
  • Health Day lets us know,
    • “Tattoos might protect against melanoma
    • “People with more tattoos were less likely to develop melanoma
    • “They might take better care of their skin, or the tats might provide some sort of screen from UV rays, researchers say.”
  • Per the American Journal of Managed Care,
    • “Colorectal cancer (CRC) screening rates remain lower in rural areas compared with urban communities, according to a new analysis of more than 535,000 adults in the US. Although education, income, insurance coverage, and provider access explain part of the disparity, more than 70% of the gap remains unaccounted for, pointing to deeper structural and cultural barriers that require equity-focused interventions.
    • ‘This analysis is published in Cancer Causes & Control.“
  • Per Fierce Pharma,
    • “Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
    • “Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
    • “By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.”
  • Per BioPharma Dive,
    • “A drug combination involving Bristol Myers Squibb’s experimental medicine iberdomide met one of its main goals in a Phase 3 clinical trial, helping to eliminate signs of multiple myeloma in significantly more enrollees than a standard regimen, the company said Tuesday.
    • “The data are from an interim analysis of a study that will continue so trial investigators can measure other goals like an impact on disease progression and survival. Bristol Myers will submit the results to health regulators, although executives have previously said an approval would probably only come if iberdomide meets its other objectives.
    • “Iberdomide is one of three protein-degrading drugs Bristol Myers is positioning as successors to blockbuster blood cancer drugs like Revlimid and Pomalyst, which it acquired through its merger with Celgene. Many of the products in its large portfolio of cancer drugs have either plateaued or are in decline.”
  • Per Medscape,
    • “A compound comprising five agonists that together tackle weight loss, glucose reduction, insulin sensitization, and blood fat normalization has shown promise in mouse models of obesity.
    • “The compound under investigation is called a quintuple agonist because, together with GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, it contains lanifibranor, a molecule that activates three different peroxisome proliferator-activated receptors (PPARs) — the alpha, delta, and gamma variants — all of which are involved in energy regulation.
    • “Notably, this is not a combination therapy — the five agonists are included in a single molecule.
    • “Daniela Liskiewicz, PhD, Institute for Diabetes and Obesity, Helmholtz Zentrum München, Neuherberg, and the German Center for Diabetes Research, both in Munich, Germany, discussed the development of the novel agonist at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.”
  • Here’s a link to the National Institutes of Health’s Research Matters newsletter.
  • Beckers Hospital Review identifies “six new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 
  • Per MedTech Dive,
    • “Multi-cancer blood tests, with the promise of detecting many cancer types from a single sample, have the potential to transform cancer screening.
    • “However, evidence is lacking to support broad use of the tests in people who do not have symptoms, according to research commissioned by the Agency for Healthcare Research and Quality and published last week in Annals of Internal Medicine.
    • “Researchers identified no completed, controlled studies reporting benefits in cancer detection, mortality or quality of life from screening with multi-cancer detection tests. They also found insufficient evidence on the accuracy and potential harm of the tests, mostly due to study limitations and unknown or inconsistent findings.
    • “Researchers from the RTI International – University of North Carolina Evidence-based Practice Center and The Ohio State University College of Medicine conducted the review.”

From the AI front,

  • The Wall Street Journal relates,
    • “AI models are being designed to predict a woman’s near-future risk of breast cancer using mammograms.
    • “Clairity’s AI model received FDA authorization and can predict a woman’s five-year breast-cancer risk.
    • “AI models outperform older risk-score calculators, but some doctors want more evidence of long-term impact.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY said it plans to build a $6.5 billion facility in Houston to make active pharmaceutical ingredients, including for a new oral weight-loss drug.
    • “The plant will bring 615 jobs to the area, including engineers and lab technicians, as well as 4,000 construction jobs while it is being built, the company said Tuesday.
    • “Eli Lilly plans to manufacture orforglipron, its first oral, small molecule GLP-1 receptor agonist, at the facility. The company expects to submit orforglipron to global regulatory agencies as a treatment for people with obesity by the end of this year.”
  • Per Fierce Healthcare,
    • “Compared to their peers, hospitals acquired by private equity reduced salary spending, cut staffing levels and experienced higher mortality rates within their emergency departments, according to a Medicare claims analysis published this week in Annals of Internal Medicine.
    • “The research, which reviewed data from 2009 to 2019, also found salary and staffing cuts among the acquired hospitals’ intensive care units, but, unlike EDs, there was no significant difference in mortality compared to other hospitals. Patient transfer rates increased in both settings among the private-equity-acquired hospitals, particularly among sicker patients, and ICU length of stay decreased.
    • “The analysis from University of Chicago, Harvard Medical School and University of Pittsburgh researchers is the latest contribution to a body of peer-reviewed evidence critical of private equity’s increasing presence among healthcare providers. It also follows a similar analysis from 2023 conducted by many of the same authors that spotted a rise in hospital-acquired adverse events among inpatients receiving care at a private-equity-acquired facility.”
  • and
    • “Pharmacy benefit manager Capital Rx has secured $400 million in fresh funding and announced a rebrand to better reflect its expansion beyond the pharmacy space.
    • “The investments include a $252 million series F round and other funding toward its securities, which is expected to close in October. Wellington Management and General Catalyst led the round, and additional supporters include Generation Investment Management, Growth Equity at Goldman Sachs Alternatives, 9Yards Capital, B Capital, Edison Partners, Prime Health Investments and Transformation Capital.
    • “With the infusion of cash, Capital Rx said it plans to lean more into its broader capabilities as a health benefits technology provider and will rebrand as Judi Health, the name of its proprietary tech stack. The company said the shift “marks a pivotal moment in addressing the fundamental inefficiencies of health benefits administration and the rising cost of care in the U.S.”
    • “The funding will also support the expansion of its PBM operations, Capital Rx said.”
  • and
    • “Health insurance startup Sidecar Health inked a partnership with Carrum Health to bring its specialty care network onto its platform.
    • “Carrum Health, a Fierce 15 of 2025 honoree, launched 10 years ago to develop value-based Centers of Excellence for employers, with the aim to revamp how the healthcare industry pays for and delivers specialty care. 
    • “Sidecar Health members will now have access to more than 1,200 vetted COE providers for surgical, cancer and substance use treatment—accessible to 90% of Americans within 50 miles of a Carrum provider, according to the companies. 
    • “Carrum’s solution makes specialty care services available at bundled prices and connects members to dedicated care navigation. The service also includes a 30-day warranty on surgery and two years on cancer care.”
  • Beckers Hospital Review relates,
    • “Walmart has expanded same-day pharmacy services to include refrigerated and reconstituted medications. 
    • “The expansion includes refrigerated access for medications such as insulin, GLP-1s and pediatric amoxicillin, according to a Sept. 22 news release from the company. Refrigerated medications make up over 30% of Walmart pharmacy sales and the company is the first retailer to deliver refrigerated prescriptions alongside everyday orders. 
    • “Once a prescription is filled, customers are notified through their Walmart pharmacy account and from there, can choose same-day scheduled delivery, on-demand delivery and express delivery with insurance applied.” 
  • BioPharma Dive tells us “why Xoma, a drug royalty firm, is hunting biotech ‘zombies.’ Distressed biotechs are facing rising investor pressure to close down, giving firms like Xoma an opportunity to step in and liquidate them for a profit.”
  • MedTech Dive explains “how SS Innovations is expanding robotic surgery’s reach. Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in over 5,000 surgeries.”

Monday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump is planning to meet with top congressional Democrats this week about the government funding impasse, White House and Capitol Hill officials said Monday, after lawmakers left Capitol Hill for a week on Friday with little movement toward averting a partial shutdown starting Oct. 1.
    • “A date and time haven’t yet been set, and Trump has a packed schedule on most days other than Wednesday.” 
  • Govexec explains the extent to which a government shutdown would affect federal employee pay and benefits. As the FEHBlog has previously noted, because Congress is in session in October, a political compromise is more likely than a government shutdown.
  • The Government Accountability Office released a report titled “Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation.”
    • “Studies show physician practices have increasingly been acquired by hospital systems, insurance companies, private equity firms, and other entities.
    • “At least 47% of physicians were consolidated with hospital systems in 2024—up from less than 30% in 2012. Studies show this consolidation can increase spending and prices, with one finding significant increases for office visits occurring in hospitals. Care quality may be the same or lower. It’s unclear how this type of consolidation affects access to care.
    • “There’s less evidence on the effects of physician consolidation with insurance companies or private equity.”
  • The American Hospital Association News tells us,
    • “The AHA expressed support Sept. 22 to House and Senate sponsors of the Medicare Advantage Prompt Pay Act (H.R. 5454/S. 2879), legislation that would apply a federal prompt payment standard to MA plans to help ensure that health care providers receive timely payments from MA plans for necessary patient services. The measure calls for plans to pay at least 95% of clean claims within 14 days for in-network claims and 30 days for out-of-network claims. MA plans would face civil monetary penalties if they miss any deadlines and also would have to publicly report compliance data, including the number of claims paid on time.”
  • and
    • President Trump Sept. 19 signed a proclamation increasing the fee to $100,000 for new H-1B petitions filed by employers, as well as implementing other restrictions on entry of certain nonimmigrant workers. The restrictions began on Sept. 21 and expire, absent extension, after 12 months. 
    • The proclamation authorizes the Department of Homeland Security and the Department of State to coordinate to take all necessary and appropriate action to implement the policies in the proclamation. 
    • According to an FAQ issued by the U.S. Citizenship and Immigration Services, the proclamation does not apply to any previously issued H-1B visas or any petitions submitted prior to Sept. 21. It also does not change any payments or fees required to be submitted in connection with any H-1B renewals. 
    • The proclamation said that the application fees can be waived if the Secretary of Homeland Security determines the hiring of these workers on an individual basis, or to work for a specific company or industry, is in the national interest. It is currently unclear if health care workers could qualify for the exemption process.” * * * 
      “In a statement shared today with the media, the AHA said, “One of the short-term strategies used by U.S. hospitals to address personnel shortages is the use of foreign-trained health care workers. While we work to educate more health care staff, the H-1B visa program plays a critical role in allowing the hospital field to recruit highly skilled physicians and other health care professionals to ensure access to care for communities and patients, including in rural and other areas where there are well-documented shortages of health care workers. The AHA is reviewing the recent memo from the Department of Homeland Security and evaluating the potential impact of these policy changes on hospitals and the communities they serve. We will also work with the Administration to stress the importance of including health care personnel in potential exemptions to these changes.” 
  • Bloomberg News informs us,
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.
    • “The initiative is part of Trump’s demands that drugmakers reduce their prices to align them with what other developed countries pay, according to the people, who spoke on condition of anonymity to discuss plans that are not yet public. 
    • “The proposed website would allow patients to search for specific medicines and be connected with platforms that sell them, the people said. Officials have discussed creating a Trump brand for the website, with “TrumpRx” one name that’s been considered, they added.
    • “Administration officials are discussing creating a website — potentially branded with President Donald Trump’s own name — that would make it easier for patients to buy prescription medicines at a discount directly from pharmaceutical companies, people familiar with the talks said.”
  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today allocated more than $1.5 billion in FY25 continuation funding awards for the State Opioid Response (SOR) and Tribal Opioid Response (TOR) grants. This funding provides critical resources to states and Tribal communities to address the overdose crisis through prevention, opioid overdose reversal medications, treatment (including medications for opioid use disorder, or MOUD), and recovery support.
    • “America’s addiction and overdose crises are tearing apart families and communities, and meeting this challenge requires honesty, courage, and bold action,” said HHS Secretary Robert F. Kennedy Jr. “We are putting power back in the hands of states and Tribes to build solutions that reflect their people and their traditions. This investment is about saving lives, restoring hope, and making our communities whole again.”
    • “With the rise of polysubstance abuse and increasing role of stimulants in overdose deaths, it has never been more important to comprehensively address the disease of addiction and the root drivers of this crisis,” said SAMHSA Principal Deputy Assistant Secretary Dr. Art Kleinschmidt. “State and Tribal Opioid Response funding provides critical resources to help prevent addiction, provide evidence-based treatment, and support long-term recovery and sobriety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today announced the mobilization of more than 70 Public Health Service officers from the U.S. Public Health Service (USPHS) Commissioned Corps to Indian Health Service (IHS) facilities across the country. This action delivers on Secretary Kennedy’s promise to strengthen the IHS, revitalize tribal health care, and ensure Native communities receive the high-quality medical support they deserve.
    • ‘Public Health Service officers, drawn from both leadership and frontline ranks, will be detailed to priority IHS sites identified as facing the most urgent staffing shortages. Senior Public Health Service officers will be detailed to strengthen leadership and operations, while additional officers will address the most urgent frontline staffing needs at IHS facilities. Today’s announcement represents one of the largest single details of Public Health Service officers to the IHS in recent years and underscores the Trump Administration’s commitment to improving health outcomes in Indian Country.”

From the Food and Drug Administration front,

  • Per FDA News releases,
    • “The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.  
    • “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.” 
  • and
    • “The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
    • “The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data, and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD.  
    • “We have witnessed a tragic four-fold increase in autism over two decades,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”  
    • “The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.”
  • The Wall Street Journal explains “What to Know About Taking Tylenol During Pregnancy”
    • Studies looking at a link between acetaminophen and autism are inconclusive; some show a link between its use during pregnancy and autism risk, while others don’t. 
    • A 2019 study published in JAMA Psychiatry found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birth were linked to greater risk of autism and attention-deficit hyperactivity disorder. 
    • Another in JAMA in 2024 of nearly 2.5 million children in Sweden found no increased risk in children when mothers took acetaminophen during their pregnancy, compared with their siblings who weren’t exposed to the medication in the womb.  
    • Part of the challenge with such studies is wading through the myriad other confounding factors when analyzing the results. 
    • Women take Tylenol during pregnancy because they are running a fever or have pain or an infection. Those problems could be the root of a potential autism risk, rather than the medication used to alleviate them, researchers said. 
    • “All of those factors in fact pose a somewhat higher risk to the developing fetus than does the Tylenol itself,” said Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University. 
    • “For studies that control for that, we see a far reduced or lowered impact of the Tylenol.”
  • STAT News discusses “What the evidence tells us about Tylenol, leucovorin, and autism. The questions of whether acetaminophen can cause the condition, or leucovorin can treat it, have been studied to a fair degree.”
    • “The case of leucovorin is simpler to explain: There are several studies that indicate the medicine can improve the performance of people with autism on standardized tests used to measure verbal ability. But these studies are quite small.
    • “One study, published in the European Journal of Pediatrics, followed 80 patients between the ages of 2 and 10 who were randomly assigned to receive either leucovorin or a placebo. Neither their families nor their doctors knew who received the treatment. At the end of 24 weeks, the children who received leucovorin scored 1.2 points higher on a 60-point scale used to measure autism severity than the children who did not.
    • “The result was statistically significant, but smaller studies are prone to false positive results. The normal course for researchers before making a recommendation would be to conduct a much larger randomized controlled trial to verify that the treatment is beneficial. Most such trials include hundreds or thousands of patients and provide the best evidence of efficacy and safety.
    • “For both acetaminophen and leucovorin, another problem exists: Generally, high-quality studies of medicines are done by pushing manufacturers to test them. But even though Tylenol, the leading brand of acetaminophen, is a big seller, both acetaminophen and leucovorin are available as generics, which means companies are less likely to pay for large observational studies or randomized controlled clinical trials.”
  • Per a related NIH press release,
    • “The National Institutes of Health has launched the Autism Data Science Initiative (ADSI), a landmark research effort that will harness large-scale data resources to explore contributors to the causes and rising prevalence of autism spectrum disorder. More than $50 million in awards will support 13 pioneering projects that draw on genomic, epigenomic, metabolomic, proteomic, clinical, behavioral and autism services data. These projects will integrate, aggregate and analyze existing data resources, generate targeted new data and validate findings through independent replication hubs.
    • “Our Autism Data Science Initiative will unite powerful datasets in ways never before possible,” said NIH Director Jay Bhattacharya, M.D., Ph.D., “By bringing together genetics, biology, and environmental exposures, we are opening the door to breakthroughs that will deepen our understanding of autism and improve lives.”

From the public health and medical/Rx research front,

  • Swiss Re, a life insurance company, considers “The future of metabolic health and weight loss drugs; Projecting mortality reductions in the US and UK populations.
    • “In the US and UK general populations, our modelled baseline scenario projects 4% and 3.2% reductions in cumulative all-cause mortality respectively by 2045, based on GLP-1 drug use. Here we assume majority use in the target overweight and obese population, with some sustained lifestyle changes but variable weight loss outcomes.
    • “Under our pessimistic scenario, in which drug use is limited and impacts are modest, the cumulative reduction would be 2.3% (US) and 1.8% (UK), we project. Yet semaglutide and tirzepatide are not risk-free drugs, and our assessment incorporates many caveats. In real world use, where people do not benefit from support to alter their lifestyle, the risks of discontinuation of the treatment, weight regain and rebound effects are all common. The loss of lean muscle mass and bone density as well as fat is also a risk.”
  • Per Beckers Clinical Leadership,
    • “In 2024, healthcare facilities voluntarily reported 1,575 serious harmful events to The Joint Commission, which has been tracking sentinel events since 1996. 
    • ‘The Joint Commission defines a sentinel event as a patient safety event that results in severe temporary harm, permanent harm or death. Because the reports are voluntary, the organization says its dataset represents a small portion of actual sentinel events and that “no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
    • “Of the 1,575 events, 21% were associated with patient death, 49% with severe harm, 21% with moderate harm, 5% with mild harm, 2% with psychological harm and 2% with no harm, according to the commission’s report. 
    • ‘With 776 voluntarily reported events, patient falls were the most frequently reported sentinel event in 2024. Falls led The Joint Commission’s annual lists in 2021, 2022 and 2023. In 2024, 51 of the reported falls resulted in patient death, 503 in severe harm and 199 in moderate harm.” 
    • The article goes onto list the other ten most common sentinel events last year.
  • Beckers Hospital Review points out,
    • “Sixty-two National Cancer Institute-designated cancer centers are urging health systems, physicians and hospital leaders to promote human papillomavirus vaccination as a form of cancer prevention.
    • “The cancer centers, alongside leading cancer research organizations and advocacy groups, have published a joint statement to raise awareness of lagging HPV vaccination rates.
    • “Even though 90% of HPV-related cancers are preventable through on-time vaccination by a child’s 13th birthday, HPV vaccination coverage has stagnated over the last three years, according to a Sept. 16 news release from MD Anderson.” * * *
    • “Read the full joint statement here.” 
  • Per MedPage Today,
    • “Adenotonsillectomy wasn’t better than just keeping an eye on young children with mild to moderate obstructive sleep apnea (OSA) over 3 years of follow-up in a small, randomized trial.
    • “Watchful waiting did result in many crossovers to surgery during follow-up, particularly among those with large tonsils at baseline.
    • “Researchers suggested that clinical decisions weigh Obstructive Apnea-Hypopnea Index values if available, evaluation of symptoms, tonsil size, the age of the child, risks of surgery, and evaluation of obesity or other comorbidities associated with increased risk of OSA.”
  • The American Medical Association lets us know what doctors wish patients knew about women’s sleep health.
  • Per Health Day,
    • “Type 2 diabetes appears to double a person’s risk for life-threatening sepsis, a new study says.
    • “Men and people under 60 with diabetes are particularly at risk for sepsis, a condition in which the immune system overreacts to infection, researchers reported this week at the annual meeting of the European Association for the Study of Diabetes in Vienna.
    • “The research confirms an association between type 2 diabetes and sepsis that’s been noted in earlier studies, said lead researcher Wendy Davis, a principal research fellow with the University of Western Australia.
    • “The best way to prevent sepsis is to quit smoking, normalize high blood sugar and prevent the onset of the micro- and macrovascular complications of diabetes,” Davis said in a news release. “That’s why this study is important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer PFE has agreed to pay up to $7.3 billion for weight-loss drug developer Metsera MTSR in a deal that gets the New York drugmaker back into the burgeoning market for obesity drugs.
    • “Pfizer on Monday said it would pay an initial $47.50 a share, or about $4.9 billion, for Metsera, a nearly 43% premium to Friday’s closing price of $33.32 for the New York company.
    • “The deal, slated to close by the end of the year, includes up to an additional $22.50 a share tied to milestones that could bring the total consideration to $70 a share, more than double Friday’s closing price.
    • “Pfizer, which earlier this year scrapped its experimental weight-loss pill danuglipron over concerns about potential liver damage, said the Metsera acquisition adds four clinical-stage programs to its pipeline, including a GLP-1 receptor agonist that is in Phase 2 development as both a weekly and monthly injectable treatment.
    • “Metsera also has two weight-loss pill candidates expected to begin clinical trials imminently.”
  • and
    • “Roche plans to move one of its weight-loss treatment candidates to late-stage trials next year, as the Swiss pharmaceutical group aims to become a top-three player in the booming market.
    • “The group said Monday that the experimental drug, called CT-388, showed strong efficacy in early-stage studies and that mid-stage trials were under way. A late-stage, or phase 3, study is set to begin in the first half of 2026, it said.
    • “Roche’s aim is to become a strong entrant in the weight-loss market before 2030 and eventually a top-three competitor in the field, the head of the group’s pharmaceuticals business, Teresa Graham, said at a company event with investors in London.” * * *
    • “CT-388 is a medication injected weekly that, like Lilly’s Mounjaro and Zepbound drugs currently on the market, activates both glucagon-like peptide 1, or GLP-1, hormones and a second class of hormones to help suppress appetite and shed weight.
    • “Roche said the drug stands out by more precisely activating appetite- and metabolism-related pathways while avoiding those linked to side effects such as nausea and vomiting. Phase 1 results showed participants lost an average 18.8% of their body weight over 24 weeks.”
  • Per BioPharma Dive,
    • “MapLight Therapeutics, a biotechnology company making medicines for neurological diseases, filed plans for an initial public offering on Friday.
    • “In outlining an offering, MapLight aims to become the second drugmaker to recently price a sizable IPO following a monthslong drought. LB Pharmaceuticals raised $285 million earlier this month, but the last company to carry out a large offering before that was Aardvark Therapeutics in February, according to BioPharma Dive data. 
    • “The Redwood City, California biotech is developing its lead drug as a potential treatment for schizophrenia and Alzheimer’s disease psychosis. MapLight’s ML-007C-MA activates a pair of proteins called muscarinic receptors, which help control the release of the neurotransmitter acetylcholine. In that way, the drug is designed similarly to Cobenfy, the focus of Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics.”
  • Beckers Payer Issues notes,
    • “Aetna is expanding a program that aims to reduce readmissions for its Medicare Advantage members to ten hospitals by the end of 2025.
    • “The insurer is currently implementing the clinical collaboration program at Merriam, Kan.-based AdventHealth Shawnee Mission, Houston Methodist, and Raleigh, N.C.-based WakeMed Health & Hospitals, according to a Sept. 22 news release. 
    • “The initiative aims to reduce 30-day readmission rates and hospital stays by integrating Aetna nurses directly into hospital care teams, focusing on post-discharge care to help MA members transition back home or into skilled nursing facilities.” 
  • Modern Healthcare adds,
    • “The number of hospitals faced with readmissions penalties of at least 1% come Oct. 1 is set to rise to the highest number since fiscal 2022.
    • “Prior to fiscal 2026, the number of hospitals facing readmissions penalties of 1% or more had dropped for five consecutive years. But preliminary data released Friday by the Centers for Medicare and Medicaid Services showed the number of hospitals set to pay penalties of 1% or more under the Hospital Readmissions Reduction Program will increase to 8.1%, or 240 hospitals, in fiscal 2026 compared to 7%, or 208 hospitals, in fiscal 2025.
    • “However, the number of hospitals facing no readmissions penalties next fiscal year, which starts Oct. 1, remained relatively flat compared to fiscal 2025, rising to 21.8%, or 641, from 21.4%, or 638.”
  • Healthcare Dive reports,
    • “CVS pharmacy services subsidiary Omnicare has filed for Chapter 11 bankruptcy after being hit with a $949 million federal judgment over improper billing of government healthcare programs.
    • “Omnicare claimed up to $500 million in assets and between $1 billion and $10 billion in debts in its bankruptcy petition with a Texas court on Monday.
    • “Omnicare has brokered an agreement to receive $110 million in debtor-in-possession financing, a type of loan which it expects will allow it to continue operating through the bankruptcy process, the company said.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”