Monday report

Congress

Monday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC

  • Per a November 28, 2025, Congressional news release,
    • “Today, House Committee on Oversight and Government Reform Chairman James Comer (R-Ky.) announced a markup will take place on Tuesday, December 2 at 10:00am ET to consider a series of legislation to reform procedures in the federal workforce, to promote greater transparency, and bring accountability to federal agencies and the District of Columbia.
    • “The American people deserve a productive federal government that provides transparency and accountability across all agencies, processes, and procedures. The House Oversight Committee is dedicated to ensuring that Americans’ voices are not diluted and that they can be employed in the federal workforce without undue burdens and other hinderances. Working in tandem with President Trump’s mission to reform the federal government, the Committee will do its part to examine the efficiency of agencies’ operations and remove any barriers that prevent Americans from fully participating in them,” said Chairman Comer.” * * *
    • “The markup will be open and available to the public and press and will be livestreamed online at https://oversight.house.gov/.”
  • Beckers Health IT tells us,
    • “A bipartisan group of federal lawmakers has introduced a bill they say would extend the availability of healthcare AI to rural Americans and seniors.
    • “The Health Tech Investment Act would assign all FDA-approved AI-enabled devices a temporary payment classification for a minimum of five years, pending the sufficient collection of cost data and the issuance of a permanent CMS payment code.”
  • Bloomberg News informs us,
    • “The US Office of Personnel Management is ending a program that gives federal workers discounted college tuition. 
    • “OPM Director Scott Kupor said in a memo Monday that the office would cancel the Federal Academic Alliance at the end of the current academic term. The voluntary partnership between universities and the federal government offered special rates for government employees and their families.
    • “Kupor wrote that the program is outdated and rarely used, with less than 0.2% of the federal workforce participating. More agencies are offering their own training programs, he said.”
  • Politico adds,
    • “The Trump administration wants federal agencies to shuffle top civil servants to more effectively implement the president’s agenda.
    • “The head of the Office of Personnel Management on Monday issued guidance encouraging agency leaders to review their rosters of top civil servants known as the Senior Executive Service and to consider reassigning them to new posts.
    • “The guidance marks the Trump administration’s latest move to overhaul the federal workforce and its senior management. The administration says the move will help dislodge “entrenched” civil servants, but critics accuse the administration of exerting undue political influence over federal workers.”
  • The Congressional Research Service released a report offering its analysis of No Surprises Act Independent Dispute Resolution data for 2024.
    • “The year 2024 marks the first year in which the IDR process was operational throughout the year without suspension, since it first began accepting dispute submissions in April 2022. This report, building on a prior CRS report analyzing 2023 data on IDR operations, reviews and analyzes data made publicly available by the Departments of Health and Human Services, Labor, and the Treasury—pursuant to NSA requirements—regarding IDR operations in calendar year 2024. In general, the data show an IDR process that was still maturing in 2024, as the year saw significant increases in the use of the IDR process (relative to 2022 and 2023) by providers; a large increase in the number of determinations made relative to 2023 and improvements in the amount of OON emergency/nonemergency service dispute determinations made within the generally required 33 business days (though a majority of determinations were still made outside of that window); and continued notable increases in payment determination amounts in certain medical specialties.”
  • Per the American Hospital Association News,
    • “The Centers for Medicare & Medicaid Services Innovation Center will launch a new, outcome-aligned payment model for providers offering technology-supported care to individuals with Original Medicare for managing common chronic conditions. The Advancing Chronic Care with Effective, Scalable Solutions Model will focus on conditions such as high blood pressure, diabetes, musculoskeletal pain and depression. CMS said it will pay participants in fixed installments for managing patients’ qualifying conditions, with full payment tied to achieving measurable health outcomes. CMS will begin accepting applications for the 10-year voluntary model Jan. 12, 2026, with an initial deadline of April 1, 2026. The model will begin July 1, 2026.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Dec. 1 that it intends to expand the Inpatient Rehabilitation Facility Review Choice Demonstration to include IRFs in Texas and California. The demonstration, which is currently active for IRFs in Alabama and Pennsylvania, subjects all Original Medicare IRF claims to either pre-claim or post-payment review. IRFs in Texas will need to select either pre-claim or post-payment review by Feb. 13, 2026, and the demonstration will begin March 2, 2026. IRFs in California will need to select pre-claim or post-payment review by April 14, 2026, and the demonstration will begin on May 1, 2026. The AHA has opposed this demonstration, indicating its unnecessarily burdensome nature, and will continue to encourage the agency to pause its expansion.” 
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Martin Kulldorff, Ph.D., as chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE).  Kulldorff recently chaired the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and previously taught at Harvard Medical School. He is a biostatistician and epidemiologist with more than 200 peer-reviewed publications.
    • “ASPE serves as HHS’ in-house think tank, providing policy advice to the Secretary. It also leads special initiatives, coordinates departmentwide research and evaluation activities, manages major planning processes, and produces analyses and cost estimates for policy options across public health, health care, and human services.”
  • The Wall Street Journal reports,
    • “The U.K. will increase the net price paid for new patented medicines by 25% to avoid U.S. tariffs on pharmaceutical exports.
    • “The U.K. government will reduce the clawback tax on high-value drugs to 15% next year, down from as much as a quarter or more.
    • “The U.S. guaranteed zero tariffs for U.K. pharmaceutical exports for at least three years as part of the agreement.”
  • Bloomberg Law adds,
    • “A deal between President Donald Trump and Novo Nordisk A/S to slash Ozempic and Wegovy prices under a most-favored-nation plan will override the costs for the blockbuster drugs negotiated separately by the Medicare agency.
    • “Due to the terms and timelines of the negotiated deals, the MFN prices for covered GLP-1 drugs are expected to supersede the IRA prices,” a spokesperson for the Centers for Medicare & Medicaid Services said in an email Friday.” * * *
    • “The prices under the most-favored-nation plan are scheduled to launch in 2026, while the negotiated drug prices for the second were slated to run in 2027.”
  • Fierce Pharma further adds,
    • “On the heels of striking a deal with the Trump administration to reduce the prices of several of its most popular drugs for U.S. patients, Eli Lilly has unveiled additional savings for cash-paying users of its obesity and sleep apnea med Zepbound.
    • “In the early November announcement of its agreement with the government, Lilly pledged to reduce the self-pay price of Zepbound in multidose pen form—which has yet to be approved by the FDA. Once the approval is secured, the multidose pens will be available via the LillyDirect online pharmacy platform for $299 to $449.
    • “Monday’s announcement adds discounts to single-dose vials of Zepbound, which are already approved and available in the U.S. Self-paying patients prescribed the GLP-1 will now be able to access the vials at $50 to $150 off their previous prices on LillyDirect.”
  • Per Politico,
    • “Three blockbuster drugs will exit Medicare’s price negotiation program in 2027 after regulators determined they now face generic or biosimilar competition, according to a Centers for Medicare and Medicaid Services memo obtained by POLITICO.
    • “The removal means that Novartis’ chronic heart failure treatment Entresto, Janssen’s anti-inflammatory medicine Stelara, and Bayer and Janssen’s blood clotting drug Xarelto will no longer be subject to the negotiated price reached during the first cycle of Medicare drug price talks.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities for all agency employees. Agentic AI capabilities will enable the creation of more complex AI workflows — harnessing various AI models — to assist with multi-step tasks.
    • “Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes. The tool is entirely optional for FDA staff and is used voluntarily.  
    • “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” said FDA Commissioner Marty Makary, M.D., M.P.H. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
  • Beckers Hospital Review relates,
    • “Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.
    • “MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product. The FDA said unauthorized individuals could potentially change device therapy settings or access device data if it is left unattended, which could lead to the life-supporting air delivery function not working as intended.   
    • “In addition, the FDA identified Class I recalls of Becton Dickinson Alaris Pump Modules and Balt USA Mega Ballast Distal Access Platforms.”  

From the judicial front,

  • The American Hospital Association New points out,
    • “The AHA, the Maine Hospital Association and four safety-net health systems from across the country Dec. 1 filed a lawsuit in the U.S. District Court for the District of Maine to challenge the 340B Rebate Model Pilot Program. The AHA and its co-plaintiffs are seeking a temporary restraining order to stop the rebate program from going into effect Jan. 1, 2026.
    • “If implemented, the program would impose overwhelming financial and administrative burdens on 340B hospitals, many of which already operate on razor thin margins while playing a vital role in their communities, often serving as the only source of care. The lawsuit alleges that the Department of Health and Human Services’ decision to move forward with the rebate program through a rushed, opaque process violates the most basic principles of administrative law, including by ignoring the concerns of over 1,000 340B hospitals and other stakeholders, many of which highlighted the significant costs and community impact of administering the rebate model.”

From the public health and medical / Rx research front,

  • Genetic Engineering and Biotechnology News reminds us,
    • “World AIDS Day, first observed on December 1, 1988, is an international day to raise awareness of the global HIV/AIDS pandemic. Since its inception, the website notes, communities have stood together to show strength and solidarity against HIV stigma and to remember lives lost. 
    • “As of 2024, over 40 million people in the world are diagnosed with human immunodeficiency virus (HIV)—a chronic, life-threatening infection that remains one of the leading global causes of death. Today, we take a moment to reflect on the progress made in the global fight against HIV, while recognizing the challenges that remain.”
  • The Washington Post reports,
    • “A small, highly anticipated study shows a glimmer of hope in the long effort to control HIV without medication and search for a cure for a virus that attacks immune cells.
    • “Researchers gave 10 people with HIV a complex regimen of experimental immunotherapies, then discontinued the daily pills that kept the virus at bay. In six participants, the virus rebounded slowly and stayed at a low level for months, and one person’s immune system kept the virus in check for more than a year and a half — giving scientists hope that they could optimize the approach to create a cure.
    • “It’s provocative, but I’ve been doing treatment interruption studies for 30 years, and this is unexpected and unparalleled,” said Steven Deeks, a professor of medicine at the University of California at San Francisco and one of the leaders of the study. He and other scientists were quick to caution that this is a promising step forward, not a solution. The small study did not include a control group, so more studies will be needed to confirm and flesh out the exciting signal.”
  • Healio tells us,
    • “From 2008 to 2023, there has been a significant decrease in cystic fibrosis mortality rates and a significant rise in sickle cell disease mortality rates in the U.S., according to findings published in JAMA Pediatrics.
    • “For frontline clinicians, these results are a call to action,” Nansi S. Boghossian, PhD, associate professor in the Arnold School of Public Health at the University of South Carolina, told Healio. “They highlight the barriers many patients with sickle cell disease face including limited access to proven therapies, under-resourced systems and the high costs of newer treatments.”
  • NBC News explains why “Doctors seek to understand why quitting antidepressants causes withdrawal for some. A “deprescribing” movement is building up in the psychiatry field, aimed at helping patients reduce or stop their medications when no longer considered necessary.”
  • MedPage Today informs us,
    • “Changes in driving frequency, complexity, and spatial range were associated with mild cognitive impairment in older adults.
    • “Trip distances, speeding, and destination variability distinguished mild impairment from normal cognition with strong predictive accuracy.
    • “Continuous, real-world driving data may signal impairment before safety events occur, researchers suggested.”
  • The American Medical Association lets us know what doctors wish their patients knew about end of life care planning.
  • Per Health Day,
    • “About half of people who die by suicide show no prior warning signs.
    • “Many do not have mental health diagnoses or genetic psychiatric risks.
    • “Researchers hope to improve how doctors screen for suicide risk.”
  • Per BioPharma Dive,
    • “An experimental drug from Belite Bio succeeded in a Phase 3 trial in the most common form of Stargardt disease, positioning the company to seek regulatory approval next year of what could be the first marketed medicine for the condition.
    • “According to Belite, treatment with its drug, known as tinlarebant, was associated with a roughly 36% reduction in the growth rate of retinal lesions compared to a placebo over the course of two years, meeting the trial’s main goal. Both study groups had a minimal overall change in visual acuity, but Belite said that finding was “consistent” with historical data.
    • “Belite said tinlarebant was “well tolerated,” with only four patients stopping treatment due to adverse events. The most common eye side effects related to treatment were a type of color vision deficiency and issues seeing at night or adjusting to a dark environment. The majority of those cases were mild, and most resolved during the trial, the company said.”

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

  • Fierce Healthcare identifies its ten Women of Influence for 2025. Congrats to these ladies.
  • Fierce Healthcare adds,
    • “As healthcare providers increasingly adopt artificial intelligence tools, researchers, physicians and health tech companies are moving quickly to assess the verifiable impact of these technologies.
    • “Early studies looking at the use of AI tools, such as ambient scribes, among physicians are showing promising results. The use of AI scribes leads to lower burnout and lighter cognitive load for users, plus measurable cuts in documentation time, according to recent studies.
    • “Primary care doctors are also reporting that AI features embedded in the electronic health record (EHR) are helping them provide higher-quality care, according to a new survey from Elation Health.”
  • STAT News adds,
    • “The biggest radiology practice in the United States is leaning even further into artificial intelligence. The tech arm of Nashville-based Radiology Partners, which includes more than 4,000 radiologists reading more than 55 million images every year, last month acquired a new AI company for $80 million: Cognita Imaging, a Stanford researcher-founded startup that’s hoping to win the race to capitalize on foundation models in radiology.
    • “By training vision-language models on large numbers of radiological images and their written radiology reports, the hope is that AI will be able to read an X-ray or CT scan like a radiologist would: Not just by looking for a single, predetermined abnormality, but for any finding that looks important. Many existing and new radiology companies have launched themselves at that goal, despite concerns about whether such broadly-targeted technology can be validated and used safely.”
  • Beckers Health IT notes that
    • “Hospital-at-home treatment could be one way to “solve the rural healthcare crisis,” researchers from Somerville, Mass.-based Mass General Brigham say.”
  • and
    • “EHR vendors have expanded their patient-record sharing capabilities in recent years, but clinicians still report little improvement in how usable that data is, a Dec. 1 report from KLAS Research found.
    • “The report examines provider-to-provider record exchange, third-party application integration and payer-provider data sharing.”
  • Beckers Hospital Review tells us,
    • “Estes Park (Colo.) Health officially joined Aurora, Colo.-based UCHealth Dec. 1 as UCHealth Estes Valley Medical Center.
    • “This not only gives us financial stability and additional access to resources and subject matter experts, but also assistance in recruiting and retaining staff and providers, and importantly, continued access to healthcare for our patients,” Vern Carda, president of Estes Valley Medical Center, said in a news release.” 
  • BioPharma Dive informs us,
    • “Regeneron Pharmaceuticals is putting more money into gene editing, announcing Monday a partnership with Tessera Therapeutics to develop an experimental program for a rare liver and lung disease. 
    • “At the center of the deal is a treatment Tessera, a well-funded startup backed by Flagship Pioneering, is developing for alpha-1 antitrypsin deficiency. Regeneron is paying Tessera $150 million upfront, in the form of cash and an equity investment, to collaborate on the program and split future development costs and profits. Tessera could receive another $125 million in unspecified near and mid-term development milestone payments.   
    • “Tessera will lead the initial first-in-human trial, with Regeneron taking the reins for future development and eventually commercialization.” 

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Roll Call offers a preview of these Capitol Hill activities.
  • The Centers for Medicare and Medicaid Services posted fact sheets on the following topics:

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A recently recognized form of dementia is changing the understanding of cognitive decline, improving the ability to diagnose patients and underscoring the need for a wider array of treatments.
    • “Patients are increasingly being diagnosed with the condition, known as LATE, and guidelines advising doctors how to identify it were published this year. LATE is now estimated to affect about a third of people 85 and older and 10 percent of those 65 and older, according to those guidelines. Some patients who have been told they have Alzheimer’s may actually have LATE, dementia experts say.
    • “In about one out of every five people that come into our clinic, what previously was thought to maybe be Alzheimer’s disease actually appears to be LATE,” said Dr. Greg Jicha, a neurologist and an associate director of the University of Kentucky’s Sanders-Brown Center on Aging.
    • “It can look like Alzheimer’s clinically — they have a memory problem,” Dr. Jicha said. “It looks like a duck, walks like a duck, but then it doesn’t quack, it snorts instead.”
  • The Washington Post relates,
    • “Vaccines don’t just shield you from specific infectious diseases or help make symptoms less severe if you get sick but can also prevent common chronic illnesses, including some cancers, according to public health experts.
    • “We now have a more full understanding of how these vaccines go beyond just protecting us against the disease that they helped prevent,” said Richard Martinello, chief medical officer and infectious diseases physician at Yale School of Medicine.
    • “In addition to cancer, a growing body of research has shown that vaccines can reduce the risk of developing dementia and heart conditions. Vaccines can also help people with existing chronic conditions avoid getting sicker.”
    • The article identifies the common vaccines experts recommend
      • HPV
      • Shingles
      • Hepatitis B
      • Flu, coronavirus and RSV,
      • Bacterial vaccines
  • The Wall Street Journal reassures us,
    • “Why does a glass of wine make a holiday party feel more festive? It might be because our forebears used to party.
    • “Not the ancient Greeks, though they did name a god of wine. Go back even further than that—some 50 million years further, when our primate ancestors began seeking out fermented fruits that naturally contained ethanol, scientists say.
    • “Those that could sniff out ethanol (or alcohol)—which gives off an odor, as we all know from the smell of a beer hall—were rewarded with a tasty nutritional gold mine: plant carbs and calorie-rich ethanol.
    • “All primates can metabolize ethanol, mining it for energy. But research that examined enzymes from ancestral primates indicated that around 10 million years ago, a digestive enzyme mutation allowed African apes—including the common ancestor of humans, gorillas and chimpanzees—to metabolize that alcohol 40 times more efficiently than other primates.
    • “The change made it even more beneficial to be able to find and consume alcohol in the wild, according to Nathaniel Dominy, a professor of anthropology at Dartmouth College.
    • “Fast forward to the advent of agriculture roughly 10 millennia ago, and humans began making alcohol intentionally in large and potent quantities. Today, of course, we have wide access to it.
    • “It’s been argued that the whole reason we domesticated cereals in the first place was to make beer, not bread,” Dominy said. “Our brains are wired to like it.”
  • Medscape points out,
    • “Among patients with obesity and type 2 diabetes (T2D), those who underwent metabolic bariatric surgery experienced greater weight loss and reductions in A1c levels than patients who did not undergo surgery.” * * *
    • “These results support current clinical guidelines that recommend metabolic bariatric surgery for individuals with severe obesity or obesity-related complications who do not achieve adequate results through more conservative treatments,” the authors of the study wrote.”

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

  • Beckers Health IT reports,
    • “Amazon plans to invest up to $50 billion to ramp up AI and supercomputing capabilities for federal agencies, boosting healthcare research and pharmaceutical breakthroughs.
    • “The tech giant intends to break ground on the data centers in 2026, providing Amazon Web Services’ U.S. government customers with an additional 1.3 gigawatts of AI and supercomputing capacity.
    • “We’re giving agencies expanded access to advanced AI capabilities that will enable them to accelerate critical missions from cybersecurity to drug discovery,” Amazon Web Services CEO Matt Garman said in a Nov. 24 news release. “This investment removes the technology barriers that have held government back and further positions America to lead in the AI era.”
  • and
    • Best Buy took a $192 million accounting loss after ending its hospital-at-home partnerships with health systems.
    • The tech retailer recorded the pretax, noncash asset impairments related to Best Buy Health in the third quarter of fiscal 2026, according to a Nov. 25 earnings report.
    • “The impairments were prompted by a change in Best Buy Health’s customer base during the quarter and reflect downward revisions in our long-term projections, in part due to pressures in the Medicaid and Medicare Advantage markets,” Best Buy CEO Corie Barry said in a Nov. 25 earnings call.
  • Beckers Payer Issues identifies the “[t]en providers [which] recently posted job listings seeking leaders in payer contracting and relations.
  • HR Dive informs us,
    • “After a year of mass layoffs and uncertainty, 2026 could stabilize hiring trends and bring equilibrium to the U.S. labor market, according to a Nov. 18 report from HireQuest.
    • “In particular, the job market appears to be stabilizing around skills-based hiring, the report found. In addition, late 2025 layoffs could reset — but not reverse — the market, as well as spur employee reskilling and contract-based hiring.
    • “2026 won’t be defined by a hiring boom or a bust but by more balance,” Rick Hermanns, president and CEO of HireQuest, said in a statement. “We’re seeing a labor market that’s stabilizing around new priorities: flexibility, fit and the kind of skilled work that can’t be automated.”

Tuesday report

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

From Washington, DC,

  • The Hill reports,
    • “President Trump on Tuesday said he would prefer not to extend Affordable Care Act subsidies that are set to expire at the end of the year, but he acknowledged it may be necessary to reach an agreement on health care legislation.
    • “Trump, in response to a question from The Hill, told reporters his preference was to pass legislation that gave money directly to Americans to allow them to purchase their own health care plan.
    • “I like my plan the best. Don’t give any money to the insurance companies, give it to the people directly. Let them buy their own health care plan. And we’re looking at that. If that can work. We’re looking at that,” Trump said.
    • “Asked if he is planning to extend the Affordable Care Act subsidies that were at the heart of the government shutdown debate, Trump said he’d “rather not.”
    • “Somebody said I want to extend them for two years. I don’t want to extend them for two years. I’d rather not extend them at all,” Trump said. “Some kind of extension may be necessary to get something else done, because the un-Affordable Care Act has been a disaster.”
    • “Trump told reporters he was talking with Democrats about health care, but when asked who specifically, he would not say.”
  • Roll Call adds,
    • “The front-runner to be the next top Republican on the House Budget Committee is eyeing a potential second reconciliation bill that could include tax and health care provisions that were dropped from the GOP’s “big, beautiful” package last summer.
    • “Rep. Lloyd K. Smucker, R-Pa., the first entrant and heavy favorite in the race to succeed retiring Budget Chairman Jodey C. Arrington, R-Texas, said he would like to see an extension of the Work Opportunity Tax Credit as part of a future reconciliation bill.
    • “That credit goes to employers who hire individuals from groups that face barriers to employment, such as veterans, ex-felons and recipients of Supplemental Nutrition Assistance Program benefits, among others. The credit is set to expire at the end of this year.
    • “I think there were a number of pieces of tax policy that were not included in the bill that we did, and I’d love to see some of those provisions passed,” he said.
    • “Speaker Mike Johnson, R-La., has pushed to do a second — and even a third — reconciliation package before the midterm elections, although the contours of a follow-up bill are still far from clear. But President Donald Trump has said he believes the reconciliation law that he signed in July is sufficient and that additional legislation is not necessary.”
  • The Wall Street Journal relates,
    • “The U.S. government negotiated lower prices in the federal Medicare program for 15 high-selling medicines including Ozempic, widening an effort to rein in drug costs.
    • “The new prices, which will take effect in 2027, shave 38% to 85% off the list prices for drugs for diseases including asthma, cancer and diabetes. The reductions are estimated to save Medicare, the health-insurance program for the elderly, $12 billion.
    • “For some patients, the lower prices could reduce spending on copays or other out-of-pocket charges imposed by their particular plan. Other patients taking the drugs might not see a direct savings, however, because they have fixed monthly copays. 
    • “Also, Medicare members now have a $2,000 annual cap on out-of-pocket drug costs. Yet the savings could help curb growth in plan premiums.
    • “In addition to Ozempic, other drugs that will cost Medicare less thanks to the negotiations include GSK’s Trelegy asthma treatment, Pfizer’s breast-cancer therapy Ibrance and Merck diabetes pill Janumet—all of them huge sellers.
    • “The price cuts apply to Medicare, not to private health-insurance plans. Medicare spends more than $150 billion a year on prescription drugs, and the cuts will mean reduced revenue for drugmakers. Yet some companies say the impact will be modest. 
    • “Some of the muted effect is because drugmakers already provide rebates and discounts to Medicare drug-benefit plans on many drugs. So, the negotiated prices aren’t as much of a discount off net prices as they are from list prices.”
  • Here’s a link to the CMS news release about the 2027 Medicare drug price negotiations.
  • Bloomberg adds,
    • “The Trump administration on Tuesday proposed a rule cementing changes to patient cost-sharing in Medicare’s Part D prescription drug benefit and updating the methodology used to rate private Medicare Advantage plans.
    • “If finalized, the rule, RIN 0938-AV63, would implement changes to Part D that Congress enacted as part of the Inflation Reduction Act under President Joe Biden, and update the methodology used to award insurers quality “star ratings” that determine bonuses and marketing privileges. The changes would take effect in 2027.” * * *
    • “The CMS also proposed eliminating star ratings measures that it said were based on “administrative processes” and not indicative of a plan’s quality. The agency is also proposing to forgo a change related to enrollees with social risk factors, and to add new measures focused on treating depression.
    • “The proposal would also allow Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • Here’s a link to the CMS fact sheet on this proposed rule.
  • Healthcare Dive offers a good summary of the Medicare changes found in the outpatient facility pricing final rule released last Friday. For example,
    • “Hospital outpatient departments currently receive higher reimbursement for providing the same services compared with freestanding physician offices and ambulatory surgery centers — a policy critics say drives up costs for patients and Medicare. 
    • “In the latest payment rule, the CMS finalized a regulation that would reimburse off-campus outpatient departments owned by hospitals at the same rates as physician offices for drug administration services. 
    • “That change should cut outpatient spending by $290 million in 2026, with $220 million of the savings going to Medicare and $70 accruing to beneficiaries, according to the CMS. 
    • “Additionally, the agency is moving to phase out the inpatient only list, a list of which surgical procedures have to be furnished in hospitals, over three years. The CMS will start with removing 285 mostly musculoskeletal procedures next year.
    • “The American Hospital Association lambasted the site-neutral policy changes, arguing they ignore the differences between care delivery at hospital outpatient departments and other care sites.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention appointed Louisiana surgeon general Dr. Ralph Abraham as the second in command, the latest move in a year of upheaval for the agency.
    • “Abraham, a vaccine skeptic, has been named the deputy principal director of the CDC. The agency has shuffled through multiple leaders since Health Secretary Robert F. Kennedy Jr., also a vaccine skeptic, began overseeing the CDC earlier this year.
    • “Kennedy’s views on vaccines have caused turmoil at the agency. Susan Monarez, the former CDC director, said she was ousted after refusing to approve all future recommendations from a vaccine advisory panel filled with Kennedy’s appointees and refusing to fire CDC vaccine-policy officials. Jim O’Neill, Kennedy’s deputy, is currently serving as the CDC’s acting director.
    • ‘Most recently, a CDC webpage that previously said vaccines don’t cause autism now says they might—an assertion former CDC employees and doctors outside the agency have fervently disagreed with.
    • “Abraham was appointed the Louisiana surgeon general last year and later criticized government vaccine mandates. He condemned Covid-19 vaccine mandates earlier this year as “an offense against personal autonomy that will take years to overcome.” * * *
    • “The family-medicine doctor and veterinarian also represented Louisiana in Congress from 2015 to 2021.”
  • Tammy Flanagan, writing in Govexec, opens her Mailbag: Retirement applications and processing/ A look at common retirement-processing snags, what causes delays and where OPM’s newer systems fit into the picture.”

From the Food and Drug Administration front,

  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil Speed Control Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor. The FDA said Max Mobility/Permobil reported two serious injuries associated with the issue.
    • “In addition, the FDA issued an early alert for certain Fresenius Kabi Ivenix LVP Primary Administration Sets due to an assembly defect.”
  • Per Fierce Pharma,
    • “AstraZeneca’s Imfinzi is adding yet another landmark perioperative label to its belt with a new FDA approval that gives the drug the title of the first and only immunotherapy marketed to treat early-stage stomach cancer patients both before and after surgery.
    • “With the nod, Imfinzi can be added to standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) to treat adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval specifically allows Imfinzi to be used with chemotherapy before surgery, then after surgery with chemotherapy and eventually on its own as a monotherapy.”
  • and
    • “When the FDA reworked the prescribing information for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen designed to reduce liver-associated risks and potentially reach patients left off of the drug’s new label. Now, with the FDA’s go-ahead, the company is commencing with that effort.
    • “The FDA gave Sarepta the green light to use an “enhanced immunosuppressive regimen” in the planned Cohort 8 of its Endeavor study, the company announced in a Tuesday press release. The regimen, which features the administration of sirolimus prior to and after the Elevidys infusion, will be studied in non-ambulatory individuals with DMD or those who can no longer walk independently.”
  • MedTech Dive relates,
    • “Ceribell has received 510(k) clearance to use its Clarity seizure-detection algorithm in neonates, the company said Monday.
    • “The algorithm processes data captured by a headcap with electroencephalography sensors to detect electrographic seizures. Subclinical seizures can go undetected without EEG monitoring.
    • “Ceribell executives have estimated that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity.” 
  • STAT News points out,
    • “The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website.
    • “The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Trump administration will continue to fight in court over a Biden-era regulation that would audit Medicare Advantage plans and claw back billions of dollars in overpayments.
    • “In a Friday filing, the federal government said it would appeal a judge’s decision from September that vacated the Medicare Risk Adjustment Data Validation, or RADV, rule for violating the Administrative Procedures Act.
    • “The move to take the case to the Fifth Circuit Court of Appeals comes as regulators have said they’ll crack down on MA overpayments, including through a plan this spring to increase audits.”
  • Per Fierce Healthcare,
    • “Humana will appeal a court loss over the Medicare Advantage star ratings, according to a filing issued Tuesday.
    • “The insurer filed a notice that it will appeal the District Court ruling to the Fifth Circuit Court of Appeals. The filing doesn’t offer further details on the grounds to appeal.
    • “Humana first filed suit to challenge the star ratings methodology in October 2024 after the number of people enrolled in plans with four or more stars dropped from 94% in 2024 to 25% in 2025. In the most recent round of scores, the number of enrollees in plans with at least four stars decreased further to 20% for 2026.
    • “In the lawsuit, Humana argues that the Centers for Medicare & Medicaid Services determined that three test phone calls were poor, which drove the score drop.
    • “Texas Judge Reed O’Connor tossed the case in mid-October, saying that these determinations were not “arbitrary and capricious” and instead complied with federal law.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study found people with untreated obstructive sleep apnea could have an increased risk of developing Parkinson’s disease.
    • “Researchers studied medical records for more than 11 million military veterans between 1999 and 2022 and found those with obstructive sleep apnea had a higher chance of developing Parkinson’s disease compared with those without the disorder, according to the study published in JAMA Neurology on Monday. 
    • “It’s not at all a guarantee that you’re going to get Parkinson’s, but it significantly increases the chances,” said Dr. Gregory Scott, a co-author of the study and assistant professor at the Oregon Health & Science University School of Medicine, or OHSU.”
  • A commentator in STAT News tells us,
    • “For years, federal policymakers have tweaked lung cancer screening guidelines as if the barrier to saving lives is a math problem. Add a few years to the eligibility age. Drop a few pack-years — a measure combining how much and how long someone has smoked. Remove a quit-time rule. Repeat.
    • “But it was never really a math problem. A new study in JAMA Network Open makes clear what many of us in cancer prevention and control have been warning for over a decade: No amount of technical adjusting will fix a system built on stigma.
    • “I see the effects of this every day. As a behavioral scientist and nurse practitioner, I’ve sat with hundreds of patients confronting the potential of a lung cancer diagnosis. I’ve watched people brace themselves before they say the words “I used to smoke,” even when they quit decades ago. I have watched people who have never smoked rush to explain why they got lung cancer at all.
    • “These reactions aren’t personal quirks. They are predictable responses to a system that has taught people to expect judgment.”
    • “That system is failing on its own terms. The new study examined nearly 1,000 people diagnosed with lung cancer at a major academic medical center and found that 65% would not have qualified for screening under today’s U.S. Preventive Services Task Force (USPSTF) criteria.” * * *
    • “The population ineligible for screening is not random. It is disproportionately women, Asian Americans, and people who have never smoked. These are groups the current framework structurally misclassifies as “lower risk,” despite real-world evidence to the contrary.
    • “Only one approach captures nearly all of them: age-based screening. The test itself is straightforward: a low-dose CT scan that takes about 10 minutes and exposes patients to minimal radiation. Screen everyone ages 40 to 85, regardless of smoking history, and you detect 94% of cancers and prevent more than 26,000 deaths every year.  The cost is lower than what we routinely pay for breast or colorectal cancer screening. The number needed to screen to prevent one lung cancer death is 320. For comparison, mammography requires screening about 1,339 women to prevent one breast cancer death, and colonoscopy requires screening about 455 people to prevent one colorectal cancer death. Yes, broader screening means more false positives and follow-up imaging, but these trade-offs are manageable — and far less burdensome than the status quo, which misses two-thirds of cases entirely.”MedP
  • MedPage Today lets us know,
    • “Guidelines recommend a single dose of RSV vaccine for older adults, but long-term data on the duration of protection is limited.
    • “In this study of U.S. veterans, effectiveness slid from over 80% in the month following vaccination to about 60% through 18 months. Among the immunocompromised individuals, vaccine effectiveness fell from 75% to 40%.
    • “The potential benefits and risks of a second vaccine dose in certain groups should be examined,” according to the authors.”
  • The New York Times reports,
    • “Danish researchers were examining the use of medications during and after pregnancy when they noticed a clear trend: The number of women using weight-loss drugs like Ozempic and Wegovy soon after childbirth had risen sharply.
    • ‘In 2018, few women were using the drugs during the first six months after having a baby, with fewer than five prescriptions for every 10,000 new mothers. By mid-2022, that figure had increased to 34 prescriptions for every 10,000 new mothers, and by mid-2024, it had jumped to 173 prescriptions for every 10,000, or almost 2 percent of postpartum mothers. Most of the women were over 30, and two-thirds had more than one child. A majority were overweight, but they did not have diabetes, and they had no history of using the drugs, known as GLP-1s, the researchers wrote.
    • “In a period characterized by natural weight loss and marked hormonal change, this was unexpected,” said Mette Bliddal, a pharmacologist and researcher at University of Southern Denmark in Odense, Denmark, and the paper’s first author.
    • “The new study was published online on Monday in JAMA Network Open.” * * *
    • “Although semaglutide, the active ingredient in Wegovy and Ozempic, aids in weight loss, little is known about the drug’s effects after childbirth, when new mothers are experiencing hormonal changes.
    • “The American College of Obstetricians and Gynecologists has not issued a guidance about the use of weight-loss drugs postpartum because the drugs are so new and the data is insufficient. But First Exposure, a digital information hub and research network at the University of Toronto that provides evidence-based information about drug safety during pregnancy, recommends that patients avoid taking the drugs while breastfeeding. (First Exposure also recommends not taking the medications during pregnancy and stopping them a month or two before a planned pregnancy).”

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

  • The American Hospital Association News notes,
    • “The Trump administration issued an executive order Nov. 24 launching the Genesis Mission, an artificial intelligence initiative focusing on scientific research. The program will focus on efforts related to national, economic and health security, among other areas. The order adds to other White House actions in recent months regarding AI innovation and infrastructure to support health care and other sectors.”
  • Bloomberg points out,
    • “Thousands of health providers that treat lower-income and uninsured patients are scrambling to adjust to a new program to access steeply discounted medicines from drugmakers that stands to overhaul their operations and finances.
    • “The 340B Rebate Model Pilot Program, administered by the US Health Resources & Services Administration, is set to significantly change how the 340B Drug Pricing Program operates after the Trump administration approved rebate models from pharmaceutical companies such as Bristol Myers Squibb Co., Johnson & Johnson, and Novo Nordisk A/S.
    • “Drugmakers under the federal program currently provide up-front drug discounts to covered safety-net hospitals, clinics, and health centers that treat a disproportionate number of low-income and uninsured patients. But under the pilot, covered providers, starting on Jan. 1, 2026, will buy certain medicines at full price and then submit data to drugmakers to receive a rebate.
    • “Health providers are now preparing for the pilot—grappling with nine unique drugmaker models, weighing operational changes, and analyzing the financial risks with purchasing drugs at commercial prices.”
  • Per Beckers Payer Issues,
    • “UnitedHealth Group has purchased a four-story, 79,000 square foot medical office building in Henderson, Nevada.
    • “The $46.1 million building houses Optum Nevada’s new Cactus Healthcare Center and marks the largest medical office transaction in the Las Vegas market this year, according to real estate firm Colliers.
    • “UnitedHealth purchased the building through its Sierra Health and Life Insurance subsidiary in October, the Las Vegas Review-Journal reported.”
  • Fierce Healthcare informs us,
    • “Capital Rx has unveiled Capital Equilibrium, a new level-funding pharmacy benefit management offering.
    • “The program leans on an A-rated stop-loss carrier for reinsurance as well as Capital Rx’s PBM services to provide a fixed monthly payment plan that covers anticipated claims, administrative costs and stop-loss. The pricing is often below market rates, according to the announcement.
    • “The stop-loss insurance manages claims that exceed monthly limits, while the PBM piece is built on a “fair” pricing structure that eschews traditional discounts and rebates, Capital Rx said.
    • ‘Plan sponsors in all 50 states can sign on with Capital Equilibrium, according to the announcement.”
  • Genetic Engineering and Biotechnology News identifies the “Top 20 Drugs Heading for the Patent Cliff, 2026-2029. Last year, these treatments accounted for 75% of the $236B in annual sales set to vanish with the loss of exclusivity.”
  • McKinsey & Co. delves into the five dimensions of the wellness economy.
  • Per BioPharma Dive,
    • “Gilead Sciences is looking at a new way to attack cancer, buying into a preclinical program from the Swedish biotech Sprint Bioscience.
    • “The deal announced Monday centers on a target known as TREX1. Research suggests a healthy TREX1 gene can help prevent overactivation of the immune system that leads to conditions such as lupus, but it may also help cancer cells hide from the body’s natural attackers. In oncology, researchers are trying to inhibit TREX1 to unleash anti-tumor immune activity.
    • “TREX1 has demonstrated significant potential in the preclinical phase,” Sprint Bioscience CEO Johan Emilsson said in a statement. The new agreement calls for Gilead to pay Sprint $14 million up front and as much as $400 million more if the program meets certain clinical, regulatory and commercial milestones.”

Monday report

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Mental health care, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Beckers Hospital Review reports,
    • “President Donald Trump has postponed a planned announcement of a proposal to extend enhanced ACA subsidies, CNN reported Nov. 24.
    • “Trump was expected to unveil a proposal as early as Nov. 24 that would extend the subsidies for two years while introducing new eligibility restrictions, according to earlier reports from Politico and MS Now. 
    • “The proposal, dubbed the “Healthcare Price Cuts Act,” would also establish an income cap limiting subsidies to individuals earning up to 700% of the federal poverty line, three people familiar with the plan told Politico. All enrollees would be required to make minimum premium payments, two White House officials told MS Now. 
    • “The plan also includes a health savings account component. Enrollees who switch to lower-premium marketplace plans could direct the difference in premium costs into tax-advantaged savings accounts funded with their subsidy dollars, according to both reports.
    • “Additionally, the White House intends to ask Congress to appropriate funding for cost-sharing reductions, which lower out-of-pocket expenses for ACA enrollees, Politico reported.”
  • MedCity News considers whether President Trump can do for branded expensive drugs what he just did for GLP-1s?
    • “While many are applauding the Trump administration for taking this step to expand access to GLP-1s, some believe that specifically targeting weight loss drugs actually does very little to bring down overall prescription drug costs.
    • “I think that focusing on market solutions on GLP-1s alone misses the mark, because it’s a market problem,” said Chris Deacon, principal and founder of VerSan Consulting. “[Whether it’s] GLP-1s or other medications, we have a problem of a complete lack of transparency for the purchaser.”
    • “Another expert echoed these comments, stating that while this is a positive move, there needs to be a broader effort in order to effectively bring down drug costs entirely.
    • “This is a step in the right direction,” said Edgar Asebey, an FDA regulatory attorney at Frier Levitt. “A policy initiative that is more of a blanket policy with branded drugs would be much better for the American patients.”
  • Modern Healthcare tells us,
    • “Juan Carlos “JC” Scott, president and CEO of the Pharmaceutical Care Management Association since 2018, stepped down Friday. 
    • “PCMA Chief Government Affairs Officer Lucia Lebens is serving in the president and CEO roles on an interim basis, a spokesperson for the pharmacy benefit manager trade group said Monday. The spokesperson did not respond to questions about whether Lebens also still holds the chief government affairs officer position. 
    • “A search is underway for Scott’s permanent replacement. 
    • “Scott announced in October he would be leaving the organization by the end of the year.
    • “The trade group declined to respond to a request for comment on why Scott decided to depart from the organization. 
    • “An October news release, however, said 2025 was the last year of Scott’s contract.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced five new agency leaders who will serve our nation’s families and advance goals to Make America Healthy Again. Four of these five presidential appointees required and recently received Senate confirmation.”
      • Brian Christine, MD, Assistant Secretary for Health
      • Alex J. Adams, PharmD, MPH, Assistant Secretary for Family Support, Administration for Children and Families
      • Gustav Chiarello, Assistant Secretary Financial Resources
      • Michael Stuart, General Counsel
      • Alicia Jackson, Ph.D., Director, Advanced Research Projects Agency for Health (ARPA-H)
  • The American Hospital Association News adds,
    • “The Advanced Research Projects Agency for Health announced Nov. 21 that it will fund up to $100 million in projects for quantitative measures of mental and behavioral health through its new Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health initiative. The program will focus on data regarding individual clinical outcomes and patient response to novel treatments. ARPA-H said it is seeking multimodal, longitudinal data collected in clinical trials testing the effects of rapid behavioral health interventions. The agency said the awards will be actively managed contracts, where continuation would be contingent upon satisfactory performance reviews.”
  • The National Bureau of Economic Research points out,
    • “We use comprehensive tax data to study how saving behavior responds to the Health Savings Account (HSA) “catch-up” contribution provision, which raises HSA contribution limits for individuals aged 55 and older. Using a regression discontinuity design, we find a sharp increase in contributions among those previously near the limit and smaller increases among unconstrained savers. Induced contributions are not immediately withdrawn and do not appear to crowd out retirement savings. Responses are strongest among payroll contributors and long-term savers. However, married couples do not appear to coordinate their HSA behavior to take advantage of the complex spousal rules governing catch-up contributions. Our findings highlight how tax incentives shape HSA saving and suggest that tax-advantaged account design meaningfully affects household financial behavior.”
  • Bloomberg Law informs us,
    • “Employers hope a forthcoming [federal] rule to improve surprise medical bill arbitration will strengthen their hand against doctors and improve transparency into insurers’ processes.
    • “Doctors win a high percentage of disputes, and industry groups are lobbying lawmakers and regulators to make changes, with employers arguing that doctors are abusing the process by refusing to negotiate and submitting ineligible claims for arbitration.
    • “The forthcoming rule is expected to address many of employers’ complaints, but it could also face legal fights similar to those that overturned a series of previous rules and guidance.”
  • Federal News Network interviews OPM Director Scott Kupor about the next executive development programs that OPM announced last week.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Abbott has issued a medical device correction for about 3 million Freestyle Libre 3 and 3 Plus sensors in the U.S. after determining that some sensors may provide incorrect low glucose readings, the company announced Monday.
    • “Abbott has received reports of 736 severe adverse events and seven deaths overall associated with the problem. In the U.S., 57 severe adverse events and no deaths were reported.
    • “The problem could lead to incorrect treatment decisions, such as people skipping or delaying insulin doses and excessive carbohydrate intake. Abbott said it has resolved the cause of the problem, which was related to one production line, and will replace any potentially affected sensors at no charge.”
  • Reuters notes,
    • “The U.S. Food and Drug Administration has approved Novartis’ (NOVN.S) new gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.
    • “The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and older who have a confirmed mutation in the survival motor neuron 1 gene.
    • “Itvisma contains the same active ingredient as the Swiss drugmaker’s older therapy, Zolgensma, which is approved in the U.S. to treat SMA patients less than 2 years of age.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Unlike much of Europe and East Asia, America hasn’t reached the point at which we have more people dying than we do being born.
    • “At least not in the long run. We briefly blew past that point in a few winter months at the height of the covid-19 pandemic, according to our analysis of birth- and death-certificate data collected by the National Vital Statistics System.”
    • The article digs into the details.
  • The AP relates,
    • “The U.S. flu season is starting slowly, and it’s unclear if it will be as bad as last winter’s, but some health experts are worried as U.S. Centers for Disease Control and Prevention data posted Friday shows a new version of the virus has emerged.
    • “An early analysis suggests current vaccines may still be somewhat effective against the new version of the flu, which has been the main driver of recent infections, CDC data shows.
    • “Some scientists and medical professionals are more worried about disappointing vaccination rates, a main reason why flu hospitalizations and deaths were unusually bad during last year’s flu season — one of the deadliest this century.” * * *
    • “Some sources have suggested flu vaccinations are down. Over two million fewer flu shots were given at U.S. pharmacies through the end of October compared to last year, according to data from IQVIA, a health information and research company.
    • “But the latest CDC data indicates that for children, the vaccination rate this year is about the same as it was at this point last fall, at 34%. And the vaccination rate for adults is up a few percentage points to about 37%, according to the CDC data, which relies on survey information.
    • “It is early in the season and too early to know if the increase will be sustained or what is causing it, CDC officials said.”
  • Per Health Day,
    • “Many people don’t know they have a genetic risk factor for high cholesterol
    • “Nearly 90% of people carrying variants for familial hypercholesterolemia didn’t know it
    • “Researchers say 1 in 5 had already developed heart disease”
    • “Our findings expose a blind spot in current national guidelines, which rely on cholesterol levels and family history to determine who should receive genetic testing,” lead researcher Dr. Niloy Jewel Samadder, a cancer geneticist at the Mayo Clinic Comprehensive Cancer Center in Phoenix, said in a news release.”
  • Per MedPage Today,
    • “Girls ages 16 years or younger who received HPV vaccines were 80% less likely than their unvaccinated counterparts to develop cervical cancer.
    • “Evidence from 23 studies showed with moderate certainty that HPV vaccination lowered the incidence of high-grade cervical precancers.
    • “Vaccinated persons had 25 fewer cases of anogenital warts per 1,000 participants at 48 months, regardless of HPV type.”
  • Per the Washington Post,
    • “People who stopped taking weight-loss drugs before or during pregnancy were associated with greater gestational weight gain and had a higher risk of preterm delivery and gestational diabetes compared with those who had not been prescribed the drugs before, according to a study published Monday in JAMA.
    • “Researchers from Mass General Brigham in Boston reviewed medical records from nearly 150,000 pregnancies between June 2016 and March 2025. They found that people who had been prescribed GLP-1 drugs, a class of medications used to treat Type 2 diabetes and obesity, were more likely to gain more weight than recommended during pregnancy.
    • “Sixty-five percent of 448 pregnancies among people previously prescribed GLP-1 medications included excess gestational weight gain, compared with 49 percent of 1,344 pregnancies among those who did not receive the medication but had similar characteristics to those who received a GLP-1.
    • “If we can find those at risk of cardiovascular disease early, we can treat it early and change its course and likely save lives,” Samadder said.”
  • Per BioPharma Dive,
    • “The theory that GLP-1 medicines, which have profound benefits on metabolism and heart health, can also help combat Alzheimer’s disease suffered a major blow Monday with the failure of two large, closely watched clinical trials.
    • “The studies, titled Evoke and Evoke+, together enrolled more than 3,800 people with early-stage Alzheimer’s to evaluate whether Novo Nordisk’s semaglutide can help preserve brain function. According to Novo, its drug was not significantly better than a placebo on that measure after two years of follow-up. And though semaglutide treatment did improve some biological markers tied to Alzheimer’s, it didn’t delay the progression of the disease.”
  • STAT News adds,
    • “A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines.
    • “J&J terminated its mid-stage study of the injectable medicine posdinemab, the company said Friday, after an early look at results determined the treatment would not prove more effective than placebo. J&J said it would present full data from the trial at a later date.
    • “Posdinemab’s failure could cast a shadow over a cadre of in-development Alzheimer’s treatments meant to improve on the standard of care. Biogen, UCB, and Voyager Therapeutics are developing similar treatments of their own.”
  • The New York Times discusses how certain hospitals lowered their C-section rates,
  • and tells us,
    • “Dialing down the use of social media for a week reduced symptoms of anxiety, depression and insomnia in young adults, according to a study published on Monday in the journal JAMA Network Open.
    • “Researchers followed 295 volunteers, ages 18 to 24, who opted to take a break from social media. Instructed to stay off social media as much as possible, the group on average reduced it to a half-hour per day from just under two hours. Before and after, the participants answered surveys measuring depression, anxiety, insomnia, loneliness and a number of problematic social media behaviors.
    • “Overall, they reported positive changes: On average, symptoms of anxiety dropped by 16.1 percent; symptoms of depression by 24.8 percent; and symptoms of insomnia by 14.5 percent. The improvement was most pronounced in subjects with more severe depression. At the same time, there was no change in reported loneliness — perhaps, the authors wrote, because the platforms play a constructive social role.”
  • The American Medical Association lets us know what doctors wish their patients knew about cutting down on screen time.
    • “Too much time with smartphones or TVs can do harm. Three physicians share tips on how to reduce screen time before it turns toxic.”
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian met its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment. 
    • “The German-based company didn’t release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.
    • “Results of the trial lifted optimism for asundexian’s drug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people who’d had a recent heart attack.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Optum Rx will reduce reauthorizations on 40 additional medications Jan. 1, surpassing initial goals set out earlier this year.
    • “The pharmacy benefit management arm of UnitedHealth Group first revealed earlier this year that it was aiming to reduce reauthorizations, a specific model for prior authorization, by up to 25%. The new additions bring the total number of drugs in the initiative up to 180, surpassing that 25% goal.
    • “The new group of 40 medications includes therapies for chronic conditions and two new classes of drugs: hormone therapy and injectables for knee osteoarthritis.
    • “In addition, Optum announced that it will expand the PreCheck Prior Authorization program, covering more than 45 medications beginning Jan. 1. The tool will reach 20 health systems, Optum said.”
  • and
    • “Three former Amazon employees launched a new online healthcare marketplace earlier this year aiming to make healthcare a better experience for patients. The vision, executives said, was to make healthcare as easy as shopping online.
    • “General Medicine, started by the founding team that built PillPack and Amazon Pharmacy, connects consumers to providers to either address specific medical needs or to chat about the symptoms they’re having. Consumers can use General Medicine for a wide variety of medical issues, and the platform provides both insurance and cash pricing. There’s no subscription or access fee. 
    • “General Medicine executives refer to it as a “one-stop-shop” for telemedicine, prescriptions, imaging, labs and specialists. PillPack co-founders TJ Parker and Elliot Cohen teamed up with Ashwin Muralidharan, who most recently served as technical advisor and chief of staff to Amazon’s top health executive Neil Lindsay, to launch General Medicine.”
  • Cardiovascular Business tells us,
    • “Medtronic had a strong second quarter, reporting a worldwide revenue of $8.96 billion, and earnings per share (EPS) of $1.36. Both figures exceeded the company’s expectations. 
    • “Medtronic’s cardiovascular portfolio helped lead the way with a worldwide revenue of $3.44 billion, an increase of 9.3%. 
    • “This was our strongest growth in over a decade, excluding the easy comparisons we had after the pandemic,” Thierry Piéton, Medtronic’s chief financial officer, explained during an earnings call.
    • “Ablation devices—particularly those built for pulsed field ablation (PFA)—played a critical role in Medtronic’s triumphant quarter. In fact, worldwide revenue was up 71% for cardiac ablation solutions, including a 128% increase in the United States.”  
  • MedTech Dive informs us,
    • “Insulet laid out plans for new diabetes devices at an investor event last week, including a fully automated insulin delivery system for people with Type 2 diabetes. 
    • “The company is working on updates to its current Omnipod 5 device, plans to debut its Omnipod 6 device in 2027 and expects to launch a separate, fully-closed loop system for people with Type 2 diabetes in 2028, CEO Ashley McEvoy said.  
    • “Insulet, which leads the market for insulin patch-pumps, is also working on bringing its devices to more people with Type 2 diabetes, after receiving an expanded label from the Food and Drug Administration last year.”

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, Obesity, U.S. Healthcare–

From Washington, DC,

  • Congress is out of session this week for the Thanksgiving holiday.
  • Modern Healthcare reports,
    • “President Donald Trump said he hopes to secure a solution by Jan. 30 for an impending surge in health insurance premiums for millions of Americans, the first timeline he has publicly offered for what he has pitched as an alternative to the Affordable Care Act.
    • “Trump said in an interview with Fox News Radio Friday that Republican senators Rick Scott of Florida and Katie Britt of Alabama are working on the proposal.
    • “We have a Jan. 30 day coming up, I’d like to see if we could do it by then,” Trump said. “They say, ‘well, let’s go another year.’ And I said, ‘let’s see if we can get it done by Jan. 30.’”
  • Federal News Network tells us,
    • “Last week’s conclusion of the record-breaking government shutdown was great news for federal employees in general. But for a few thousand specific feds, it was even better news. They’d been told they were about to lose their jobs completely, and as of Friday, [November 21, 2025] almost all of them have now had those notices formally rescinded.
    • “Filings the Justice Department submitted to a federal court in San Francisco on Friday indicate that each of the more than 3,000 federal workers who had received reduction in force (RIF) notices after the shutdown began have now been formally notified that those RIFs have been cancelled.
    • “That action came as a result of several provisions in the continuing resolution Congress passed last week to reopen the government. The legislation provided that not only any RIF notice an agency issued on Oct. 1 or later “shall have no force or effect,” but it also barred federal agencies from using any funding to conduct any further RIFs for as long as the current CR is in effect.”
  • Healthcare Dive informs us,
    • “Oracle Health has received Qualified Health Information Network status under the federal government’s health data sharing framework, the technology giant said Thursday. 
    • “The designation allows the Oracle Health Information Network to transfer health information between providers, payers and government agencies through the Trusted Exchange Framework and Common Agreement, or TEFCA. The HHS created the framework to facilitate the exchange of health records.
    • “Eleven data exchanges have now received QHIN status, more than double the number that were recognized when TEFCA went live at the end of 2023.” 
  • There are sixteen days left in the Federal Benefits Open Season.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “A Washington [State] resident who was the first human case of bird flu in the U.S. since February died on Friday, state health officials said. The person was an older adult with underlying conditions and had been hospitalized since early November with a strain that was previously reported in animals but never before in humans.
    • “The person had been undergoing treatment for infection with H5N5 avian influenza, the health department said in a news release. State epidemiologist Scott Lindquist said last week that the person, who was hospitalized after developing high fever, confusion and respiratory distress, was “a severely ill patient.”
    • “State officials said the risk to the public remains low. No other people involved have tested positive for influenza, and public health officials are continuing to monitor anyone who was in contact with the patient — including more than 100 health care workers — for symptoms to ensure that human-to-human spread has not occurred, the health department said.
    • “That strain of the avian influenza virus, H5N5, had previously been reported in animals but not in humans. It is part of the family of avian influenza viruses and has been seen in wild birds in other U.S. states and Canada, state officials and experts have said.”
  • The Wall Street Journal examines “why autoimmune diseases rise sharply after 50. Scientists are making progress in understanding and treating these disorders, which can go unrecognized for years.”
    • “While there is no sure way to prevent autoimmune disease, research suggests that keeping chronic inflammation in check—through a healthy diet, regular exercise, good sleep, stress control, and maintaining a healthy weight—can help support a calmer, more balanced immune system. By contrast, unproven supplements or treatments that claim to boost the immune system could do more harm than good.”
  • Per MedPage Today,
    • “Rates of pertussis, also known as whooping cough, are surging in Texas, Florida, California, Oregon, and other states and localities across the country.
    • “The outbreaks are fueled by falling vaccination rates, fading immunity, and delays in public health tracking systems, according to interviews with state and federal health officials. Babies too young to be fully vaccinated are most at risk.
    • “Pertussis cases increase in a cyclical fashion driven by waning immunity, but the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” said Demetre Daskalakis, MD, MPH, a former head of the CDC’s immunization program, who resigned in August.”
  • NPR Shots lets us know,
    • Millions of Americans have shed pounds with help from drugs like Wegovy and Zepbound.
    • But people who take these drugs often experience unpleasant side effects.
    • “They lose weight, which is a positive thing,” says Warren Yacawych of the University of Michigan, “but they experience such severe nausea and vomiting that patients stop treatment.”
    • “So, at this year’s Society for Neuroscience meeting in San Diego, Yacawych and other researchers held a session to describe their efforts to understand and solve the side-effect problem.”
    • The article discusses the expert presentation.
  • Medscape adds,
    • “The surge of demand for GLP-1s is likely very common in your practice, and during your follow-up discussions with patients, they may often share their progress on the medication. But some patients may share that they are not hitting weight-loss markers they thought they would. Some may even compare the rate of their weight loss to that of others they know.
    • As a primary care doctor, responding to this rhetoric is part of your role. [The article offers] some thoughts about messaging and directives to offer patients to get these conversations started and how to respond to feedback.
  • and
    • A first-in-human study suggested that tirzepatide — a dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist — modulated abnormal activity in the brain’s nucleus accumbens, thereby reducing food cravings and inducing weight loss in a patient with severe obesity.

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

  • Fierce Pharma reports,
    • “Maryland is becoming the home away from home for British drugmaker AstraZeneca. On Friday, the biopharma powerhouse upped its ante in the Old Line State, saying it will invest $2 billion to increase its manufacturing presence there.
    • “The funding will allow AZ to nearly double the production capacity at its flagship biologics plant in Frederick, Maryland, and also provide for the manufacture of the company’s rare disease products there for the first time, AZ said.
    • “The company will also establish a clinical manufacturing site in Gaithersburg, Maryland. The facility, which was acquired last month in a $60 million lease transfer, is the former headquarters of vaccine specialist Novavax and will host the production of molecules for medical trials, AZ added.
    • “The outlay will create 200 additional jobs at the Frederick site and 100 more at the new Gaithersburg facility, which is 25 miles to the southeast.”
  • and
    • “A Novo Nordisk challenge has driven a Pennsylvania-based telehealth company to voluntarily discontinue compounded semaglutide product claims, adding to the Danish drugmaker’s string of wins against companies selling copycat versions of its GLP-1 blockbuster.
    • “Novo challenged claims made by Regen Doctors via BBB National Programs’ National Advertising Division (NAD). The challenge centered on express and implied claims about the superiority, safety, efficacy and health benefits of Regen’s compounded semaglutide product. Novo sells the GLP-1 receptor agonist semaglutide under the brand names Ozempic and Wegovy.
    • “After the NAD began looking into the challenge, Regen told the self-regulatory body that it had permanently discontinued the claims, according to an NAD report Thursday. Regen’s actions prompted the NAD to stop reviewing the claims, and the watchdog said it will treat the discontinued claims as if it recommended that Regen stopped making the statements.
    • “The case is part of a series of challenges Novo has recently brought against semaglutide compounders via the NAD. Since June, Bayview Pharmacy, Medicine Center Pharmacyand Fletcher Family Medical Center have all voluntarily discontinued claims about compounded semaglutide. The NAD reported the conclusion of the Fletcher case one week before sharing details of Regen’s decision to discontinue its claims.”
  • Fierce Healthcare provides a look at how UnitedHealthcare is developing, deploying AI solutions.
  • HR Dive informs us,
    • “Despite increasing adoption of artificial intelligence tools at work, many U.S. employees remain uneasy about how AI may shape the future of work — and the companies that use it, according to a Monday report from SHL, a talent insight firm.
    • “Notably, 74% of workers said being interviewed by an AI agent would change their perception of the company, with 37% saying it’s “impersonal” and 23% saying it’s “innovative.” Although most workers said they’re open to interacting with an AI interviewer, they still want human involvement and accountability in the process, the report found.” * * *
    • “By 2026, 1 in 3 companies say AI will run their hiring process, according to a report from Resume.org. More than half already use AI in hiring, yet a similar amount also expressed concerns about AI screening out qualified candidates, introducing bias or lacking human oversight.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A bipartisan group of House lawmakers released text of legislation Friday aimed at avoiding the health care subsidy cliff by extending Affordable Care Act tax credits for two years while installing income caps and anti-fraud measures.
    • “Reps. Tom Suozzi, D-N.Y., Don Bacon, R-Neb., Josh Gottheimer, D-N.J., and Jeff Hurd, R-Colo., see the measure as a viable compromise that includes Democrats’ demand for a subsidy extension alongside protections sought by many Republicans. It would also significantly lengthen the open enrollment window, which would allow more people into plans, thus strengthening risk pools and lowering premiums.
    • “The text arrives as much of Congress is divided on how to approach the possible end to enhanced premium tax credits under the 2010 health care law, which expire Dec. 31. Many Republicans see any extension as propping up the ACA and won’t support such a move. Without a solution, prices for insurance through state exchanges or healthcare.gov could force people to quit the coverage.” * * *
    • “A bill from Reps. Sam Liccardo, D-Calif., and Kevin Kiley, R-Calif., that also features a two-year extension largely follows a similar framework.
    • “Unlike the Liccardo-Kiley bill, however, this legislation does not include language that would limit excessive payments to Medicare Advantage, a practice known as upcoding. The Liccardo-Kiley bill incorporated the Medicare Advantage language as an offset to pay for the tax credit extension.”
  • and
    • “At least one of the Senate’s yet-to-be-unveiled fiscal 2026 appropriations bills could be released next week, even though lawmakers will be in their districts for the Thanksgiving recess.
    • “There is a good chance the Senate will post its version of the Energy-Water bill, one of the four the Senate has not yet released, House Appropriations Chair Tom Cole, R-Okla., said Friday.
    • “The issue was discussed when the top four House and Senate appropriators met Thursday, Cole said. “I don’t know about the other three, but we raised a lot of questions about Energy and Water, since we’ve actually passed that one across the [House] floor,” he said.
    • “Senate appropriators are aiming to release that bill and potentially more of the outstanding bills — Financial Services, Homeland Security and State-Foreign Operations — next week, a source familiar with the plan said. But that plan is not final, the source said.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday that the lawmakers discussed the outstanding Senate bills and that Senate Appropriations Chair Susan Collins, R-Maine, said the text could be posted early next week.”
  • Mercer consulting offers an overview of the current healthcare care policy debate in Congress.
  • OPM Director Scott Kupor posted a new Secrets of OPM blog entry, this time about ongoing Administration efforts to right size the federal workforce.
  • Per an HHS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is improving the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and improving choices and hospital price transparency for Medicare beneficiaries. The calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule (CMS-1834-FC) advances a series of patient-focused reforms that will modernize payments, expand access to care, enhance hospital accountability, and safeguard the Medicare Trust Funds from fraud, waste, and abuse.
    • “This final rule from CMS closes the loopholes hospitals exploit to hide real prices and advances President Trump’s demand for radical hospital price transparency,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We are also confronting addiction head-on by expanding access to non-opioid treatments and implementing common-sense payment policies that make care more affordable and accessible for seniors.”
    • “We are strengthening Medicare’s foundation by protecting beneficiaries, eliminating fraud, and advancing medical innovation —all while maintaining strict provider accountability and responsible use of taxpayer funds,” said CMS Administrator Dr. Mehmet Oz. “These comprehensive reforms expand patient choice and establish the price transparency Americans need for confident healthcare decisions.” * * *
    • “The final rule can be viewed at the Federal Register at: www.federalregister.gov/public-inspection/.
    • “View the fact sheet on the final rule at: www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center.
    • “For a fact sheet on the hospital price transparency policy changes in the final rule, visit: www.cms.gov/newsroom/fact-sheets/cy-2026-opps-ambulatory-surgical-center-final-rule-hospital-price-transparency-policy-changes.”
  • The American Hospital Association adds,
    • “The Centers for Medicare & Medicaid Services released an updated notice Nov. 20 on the processing of Medicare provider claims impacted by the government shutdown. The agency said it instructed Medicare Administrative Contractors to conduct mass adjustments to any paid claims that are inconsistent with the government funding legislation, which retroactively restored many payment provisions through Jan. 30. This includes a payment adjustment for low-volume inpatient hospitals and one for the Medicare-dependent Hospital program. In addition, CMS said that hospitals can resubmit returned claims for telehealth services and the Acute Hospital Care at Home program dated Oct. 1 or later.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “Hexoskin, a Canadian medtech company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new “smart shirt” capable of long-term heart and respiratory monitoring. 
    • “The Hexoskin Medical System was designed to deliver continuous evaluations of a person’s real-time electrocardiogram (ECG) and respiratory health. Signals are then evaluated through the company’s data management platform.
    • “According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as medical researchers. The device is now approved for use during clinical trials performed in the United States, for example, delivering ECG, heart rate, respiratory rate and other activity data that can research teams can track for extended periods of time.
    • “Hexoskin has also made it a priority to use advanced artificial intelligence algorithms to seek out new digital biomarkers that work “beyond traditional cardiopulmonary monitoring.” 
  • Fierce Pharma adds,
    • “As the researchers behind Pfizer and Astellas’ Padcev and Merck’s Keytruda have taken victory laps on the heels of the positive readout of Keynote-905 study—also known as EV-303—terms like “transformational,” “practice-changing” and “new standard of care” have been put to use.
    • “With an FDA approval on Friday, the combination now has its official go-ahead as a perioperative treatment regimen for people with muscle-invasive bladder cancer (MIBC) who can’t receive chemotherapy.
    • ‘Padcev and Keytruda is the first and only approved perioperative treatment regimen for cisplatin-ineligible patients with MIBC, Pfizer said in a media statement Friday, meaning the pairing can be used before and after surgery.
  • and
    • “The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.
    • “The probe comes as the regulator says it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13, the enzyme-creating gene that underpins Takeda’s drug. The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.
    • “Takeda’s medicine was approved in November of 2023 as the first recombinant protein product for use as a preventive or on-demand enzyme replacement therapy in adults and children with the rare genetic blood-clotting disorder, congenital thrombotic thrombocytopenic purpura (cTTP). The condition is believed to be caused by a disease-triggering mutation in the ADAMTS13 gene, which produces an enzyme responsible for regulating clotting.
    • “The Tokyo-based pharma did not respond to Fierce Pharma’s request for comment on the situation by publishing time.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced Friday,
    • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old. Seasonal influenza activity remains low nationally but is increasing. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern and Southern areas of the country with emergency department visits increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.’ * * *
    • “Season Outlook
      • “CDC expects the upcoming fall and winter respiratory disease season in the United States will likely have a similar number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. CDC will update this outlook every two months throughout the season and as warranted by changes in the trajectories of any of the three diseases. Read more: 2025-2026 Respiratory Disease Season Outlook“
  • Beckers Clinical Leadership adds,
    • “Some hospitals are reporting an uptick in respiratory syncytial virus hospitalizations in recent days, though national data — delayed by the federal shutdown — has yet to offer a clear picture.
    • “Cincinnati Children’s Hospital reported an early uptick in admissions this fall, according to Hamilton County Public Health Medical Director Steve Feagins, MD.
    • “Last year, we saw it early. This year, we saw it even earlier, resulting in, like, September beginning to get some admissions and hospitalizations at Cincinnati Children’s,” he told CBS affiliate WKRC.
    • “The county reported 32 admissions in the week ending Nov. 15, up from 28 a week prior, state data shows.” 
  • The University of Minnesota CIDRAP relates,
    • “Over 40% of nearly 8,600 US adults who had advanced hepatitis B–related liver disease appear to have received no treatment for their infection, a gap especially apparent in women and Black or White patients, according to findings published yesterday in JAMA Network Open.
    • “A team led by a Stanford University researcher and including scientists from hepatitis B virus (HBV) drug maker and study funder Gilead Sciences evaluated the HBV treatment status of 8,594 infected patients included in an electronic health record data network from April 2016 to December 2022. The study focused on patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria for HBV treatment.
    • “Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC),” the researchers wrote. “Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear.” * * *
    • In a commentary in the same journal, Amir Mohareb, MD, of Massachusetts General Hospital, and Arthur Kim, MD, of Harvard Medical School, noted that the risk of perinatal HBV transmission from mother to child is very low in the United States due to the availability of HBV immunoglobulin and the HBV vaccine birth dose. 
    • “But “there is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US,” they wrote.
    • “Removing the recommendation for universal birth-dose vaccination would be a major step backward for elimination of HBV and would be potentially in direct contradiction to the Department of Health and Human Services Viral Hepatitis National Strategic Plan for the US,” they added”
  • Beckers Hospital Review tells us,
    • “The overall U.S. healthcare system received a “C” grade from a broad survey of U.S. adults, according to the West Health-Gallup Center for Healthcare in America, which released its inaugural report, “State of the States 2025: Insights on Healthcare in America.”
    • “Nationwide, the healthcare system received a “D+” for cost, a “C+” for quality and a “C+” for access. 
    • “The rankings are based on an online survey of 19,535 U.S. adults conducted June 9 to Aug. 25 across all 50 states and the District of Columbia. Respondents graded the healthcare system in their state, with letter grades converted to a 4.0 GPA scale for analysis.”
  • A medical specialist interviewed in MedPage Today identifies “13 Visible Signs of Heart Disease. What skin, nails, eyes, and more can reveal about cardiovascular disease.”
  • Health Day informs us,
    • “Even occasional or low-intensity smoking significantly increases cardiovascular and mortality risks, according to a study published online Nov. 18 in PLOS Medicine.
    • “Erfan Tasdighi, M.D., from the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease in Baltimore, and colleagues examined the relationships among smoking burden, intensity, and cessation duration across multiple cardiovascular outcomes. The analysis included data from 323,826 adult participants in 22 prospective cohort studies with median follow-up varying from 14.4 to 19.9 years.” * * *
    • “It is remarkable how harmful smoking is — even low doses of smoking confer large cardiovascular risks,” the authors said in a statement. “As far as behavior change, it is imperative to quit smoking as early in life as possible, as the [amount] of time passed since complete cessation from cigarettes is more important [than] prolonged exposure to a lower quantity of cigarettes each day.”
    • “Abstract/Full Text“
  • and
    • “The risk for motor vehicle crashes is increased after a concussion, according to a study published online Nov. 5 in BMJ Open.” * * *
    • “The risk of a motor vehicle crash after a concussion suggests current mitigating efforts are insufficient; however, driving cessation may be unreasonable since the risk also extends to patients as pedestrians,” the authors write. “Instead, clinicians might warn concussion patients to be cautious about prevailing motor vehicle crash risks along with standard anticoncussion campaigns.”
    • “Abstract/Full Text“
  • Healio points out,
    • “Child abuse is linked to long-term risk for negative health outcomes. 
    • “Boys and girls experienced decreases in confirmed maltreatment cases, but girls were subject to greater maltreatment.” * * *
    • “As a preventive measure, we need to address the drivers of maltreatment,” Richard T. Liu, PhD, director of suicide research in the division of child and adolescent psychiatry in the Depression Clinical and Research Program at Massachusetts General Hospital, told Healio. “One prominent driver of maltreatment risk is poverty. Reducing poverty would therefore be important for reducing risk for child maltreatment.”

From the U.S. healthcare business front,

  • This factoid along with more importantly this Brookings Institute report on PBM profitability support the FEHBlog’s view that cracking down on PBMs will not lower healthcare costs. The President’s efforts to lower drug costs could pay dividends.
  • Modern Healthcare adds,
    • “Eli Lilly & Co. and Novo Nordisk A/S plan to start selling their popular obesity shots to employers through a new approach that would bypass traditional drug sales channels in an effort to expand access to the costly weight-loss medicines.
    • “The drugmakers will offer Zepbound and Wegovy to companies starting Jan. 1 through Waltz Health, a firm that helps employers purchase cheaper medications. The shots will be available to employers at upfront, fixed prices, avoiding the rebates and fees that accompany traditional sales through middlemen who manage pharmacy benefits for many companies.” * * *
    • “The offering is aimed at employers that don’t cover obesity drugs right now. About 43% of companies with more than 5,000 workers cover weight-loss drugs, according to a recent survey from KFF. Thierer said four employer clients are signed up to launch the offering in January. Waltz is targeting a goal of making it available to 100,000 people by the end of the first quarter.
    • “The arrangements will only apply to the companies’ weight-loss drugs, not to similar medications intended for diabetes. Waltz will handle screening patients to see if they’re eligible for the drugs, sending prescriptions to pharmacies and supporting patients taking the drugs.
    • “Waltz was recently purchased by a larger firm, Eversana, that works with drug companies to commercialize and distribute their medications. Thierer, a former PBM executive, has said he aims to build an alternative to the “oligopoly” of PBMs and force the industry to change.”
  • Per Yahoo Finance,
    • “CVS Health® (NYSE: CVS) today announced that its Board of Directors has elected President and Chief Executive Officer David Joyner as Chair of the Board, effective January 1, 2026. Following the effective date of this appointment, Michael Mahoney will continue to serve as the Board’s Lead Independent Director, and Roger Farah, who is currently serving as Executive Chair of the Board, will continue to serve on the Board.
    • “Joyner was named President and CEO of CVS Health in October 2024, and has led significant operational, financial and cultural improvements in the Company’s performance over the past year. In recognition of his leadership, nearly 40 years of experience in the health care industry, and the Company’s future growth opportunities, the Board determined Joyner should also serve as Chair of the Board.”
  • Healthcare Dive lets us know,
    • “Western Pennsylvania-based Independence Health System plans to join West Virginia University Health System in the fall of next year, the systems announced Wednesday.
    • ‘Under the proposed merger, which is subject to regulatory reviews and approvals, Independence Health’s five hospitals as well as its affiliated physician groups will operate under WVU Medicine’s brand. 
    • “The systems say the deal will offer operational and financial efficiencies through resource sharing and allow the providers to expand clinical services and access to specialty care.”
  • Per MedTech Dive
    • “Solventum said Thursday it has struck a deal to buy wound care company Acera Surgical for $725 million in cash.
    • “The deal, which features up to $125 million in milestones, will give Solventum control of a portfolio of synthetic soft tissue repair products. Stifel analysts said in a note to investors that they believe the synthetic market “is growing at a double-digit pace.”
    • “Acera is Solventum’s first acquisition since it spun out of 3M. Solventum executives made M&A part of their focus after selling the company’s purification and filtration business to Thermo Fisher Scientific for $4.1 billion.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Heartflow’s Plaque Analysis software is an effective tool for the diagnosis and management of coronary artery disease (CAD), according to a new retrospective analysis of more than three years of data. The findings were presented at the American Heart Association’s Scientific Sessions 2025 conference.
    • “The FDA-cleared Plaque Analysis software was designed to evaluate coronary CT angiography (CCTA) results and provide cardiologists with an artificial intelligence (AI)-powered assessment of the patient’s coronary plaques. It delivers an interactive 3D model of the coronaries and identifies high-risk CAD patients who may benefit from immediate care. 
    • “This latest analysis included nearly 8,000 symptomatic CAD patients who participated in the FISH&CHIP study. All patients were treated with Plaque Analysis as well as Heartflow’s new Plaque Staging framework. Plaque Staging separates patients into one of four categories—mild, moderate, severe or extensive—based on AI-powered total plaque volume (TPV) measurements. According to Heartflow, this study represents the largest validation to date of the Plaque Staging framework.”
  • McKinsey & Co. explores “the coming evolution of healthcare AI toward a modular architecture.”
  • The Advanced Research Projects Agency for Health (ARPA-H) announced
    • “The AIR program [which’ aims to solve these problems by developing robots that can do parts of or entire surgical interventions on their own. The program’s focus is twofold: first, to develop autonomous robotic systems that can perform thrombectomies, making curative stroke care available to all Americans. Second, to create very small, mechanical, electronic, or hybrid devices (microbots) that can perform medical procedures independently, revolutionizing healthcare delivery.
    • “Notice ID: ARPA-H-SOL-26-146
      • ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
    • “Key Dates:
      • Proposers’ Day: December 16, 2025, Bethesda, MD (Hybrid)
      • Solution Summaries due: January 26, 2026
      • Proposals due: March 30, 2026
    • “Reminder: Dates are estimates and are subject to change. Please reference the solicitation for the most up-to-date information.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The top four House and Senate appropriators met Thursday for the first time since the partial government shutdown but emerged with no breakthroughs that could pave the way for a new spending package.
    • “The meeting marked a small, positive step toward bipartisan negotiations that would be needed for an eventual deal. But so far, the two chambers and the two parties remain on different paths when it comes to fiscal 2026 spending bills.
    • “Senate Appropriations Chair Susan Collins, R-Maine, favors moving a massive package of up to five bills, featuring the two largest — Defense and Labor-HHS-Education. But there is no sign of any bipartisan agreement on overall spending limits, a major impediment to moving a package that would well exceed $1 trillion and make up the bulk of the year’s discretionary spending.
    • “By contrast, House Appropriations Chairman Tom Cole, R-Okla., wants to move a smaller batch of bills that could conceivably be enacted before Christmas.
    • “House Appropriations ranking member Rosa DeLauro, D-Conn., said no decisions about the contents of the next package were made during the meeting, though it was discussed. Senate Appropriations ranking member Patty Murray, D-Wash., also attended.”
  • Healthcare Dive tells us,
    • “Republicans and Democrats in Congress remain largely stuck in partisan gridlock over how to lower healthcare costs. But one area of potential compromise emerged during a contentious Senate Finance Committee hearing on Wednesday — resuscitating pharmacy benefit manager reform.
    • “Senate Finance Chair Mike Crapo, R-Idaho, and Ranking Member Ron Wyden, D-Ore., plan to reintroduce a bipartisan package cracking down on PBMs, middlemen in the drug supply chain, Crapo said during the hearing. 
    • “The legislation almost made it out of Congress late last year as part of a larger appropriations bill but eventually failed after public opposition from billionaire Elon Musk, a key ally of President Donald Trump at the time. Crapo said the PBM legislation would be reintroduced “shortly” and hopefully moved to the president’s desk soon after.”
  • The FEHBlog strongly doubts that “cracking down” on PBMs will lead to lower healthcare costs.
  • Genetic Engineering and Biotechnology News informs us,
    • “A bipartisan group of senators and representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE), inspired by recommendations from the National Security Commission on Emerging Biotechnology (NSCEB) April 2025 Action Plan for Congress.
    • “In the Senate, the legislation was introduced by Sen. Coons (D-DE) and Sen. Budd (R-NC), and in the House, the bill was introduced by Rep. Houlahan (D-PA, 06), Rep. Baird (R-IN, 04), Rep. Rouzer (R-NC, 07), and Rep. Ross (D-NC, 02).
    • “The bill would create a public-private partnership focused on advancing innovation in biopharmaceutical manufacturing methods, especially for products important to U.S. national security, health security, and economic security. It would also improve regulatory understanding of innovative manufacturing methods and provide workforce training opportunities in this fast-growing field.”
  • Bloomberg lets us know,
    • The Health and Human Services Department is proposing new initiatives for the Centers for Disease Control and Prevention, including a program to increase hepatitis B screening for pregnant women, as part of a broader push to restructure the agency, according to an internal document viewed by Bloomberg News.
    • Leading five of the 16 initiatives is Sam Beyda — a carryover from the Department of Government Efficiency — who was recently named deputy chief of staff at the CDC, according to people familiar with the matter who were not authorized to speak on the subject. 
    • The new programs are not yet formalized, with details to be settled before they are rolled out to the CDC in January, the document said. The list was developed over the last several months in collaboration with HHS senior advisers and CDC leadership. It includes strategic reviews on existing initiatives.
  • Per a CMS news release,
    • “On November 20, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after Jan. 1, 2026. This final rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and updates requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2026, CMS will increase the ESRD PPS base rate to $281.71, which CMS expects to increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%. The CY 2026 ESRD PPS final rule also includes a new payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories.
    • “CMS is shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions. CMS is also eliminating three health equity reporting measures from the ESRD QIP. CMS also is finalizing the early termination of the ESRD Treatment Choices Model.”
  • The American Hospital News adds,
    • “The Centers for Medicare & Medicaid Services will retroactively pay claims for telehealth services provided during the government shutdown through Jan. 30, the agency said in an updated FAQ Nov. 20. Telehealth flexibilities will expire at the end of January if government funding is not extended. CMS added that some telehealth practitioners could list their physical practice location instead of their personal address on Medicare enrollment and billing forms when they provide telehealth services from their home. Virtual-only telehealth practitioners will need to enroll their home address as a practice location, but they will have the option to suppress their street address details.” 
  • The Government Accountability Office (GAO) released a report about “Health Savings Accounts: Information on Features and Use, and Characteristics of Account Holders” and a WatchBlog post about “Who Benefits from Health Savings Accounts?”

From the Food and Drug Administration front,

  • The New York Time reports,
    • “ByHeart, the company linked to an outbreak of botulism from infant formula, said late Wednesday that a private lab had found the bacteria that causes the illness in samples of its product.
    • “So far, 31 babies in 15 states have been hospitalized, many in intensive care units, after becoming weak and unable to swallow. No deaths have been reported.
    • “ByHeart said in a statement that it sent its formula to an independent testing lab on Nov. 7, as soon that the Food and Drug Administration notified the company about the outbreak.”
  • STAT News points out,
    • “Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company’s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis. 
    • “The Austin-based company is one of a handful of startups — including Elon Musk’s Neuralink, Synchron, and Precision Neuroscience, among others — that have transformed brain-computer interfaces from an obscure academic niche to a promising neurotechnology that Morgan Stanley recently valued at $400 billion.” 
  • Fierce Pharma notes,
    • “After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug.
    • “The FDA has signed off on Eylea HD for patients with macular edema following retinal vein occlusion (RVO), making it the first treatment available in the indication with dosing up to every eight weeks. The agency also endorsed a monthly dosing option for Eylea HD across each of its approved indications, which include wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and now RVO.
    • “The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker’s long-acting treatment can be administered up to every four months, as opposed to Regeneron’s original 2 mg version of Eylea, which has a maximum dosing interval of every two months.” 
  • Per Radiology Business,
    • “Siemens Healthineers has issued a correction for its 3T MRI systems that were recently the subject of a Class 1 recall. 
    • “Siemens first alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings in August. Authorities said there have been problems with the systems’ ventilation, which could be subject to pressure buildup of helium in the event of a quench—rapid loss of superconductivity in the machine’s magnet. Such a buildup could cause the helium containment system to rupture and leak helium into the scanning room or potentially trigger an explosion. The issue was categorized as a Class 1 recall due to its potential to cause serious bodily harm or death. 
    • “The U.S. Food and Drug Administration announced the recall in early October. Now, Siemens is issuing an official device correction with more detailed information to assist operators in the event of a system error that could trigger the issue.” 

From the judicial front,

  • Bloomberg Law reports,
    • “The 11th Circuit denied an air ambulance company’s attempt to overturn a surprise billing arbitration award, delivering another blow to medical providers trying to challenge the decisions in court.
    • “Wednesday’s ruling confirms the U.S. District Court for the Middle District of Florida’s decision that REACH Air Medical Services LLC lacked a right to sue Kaiser Health Plan Inc. after losing arbitration under the No Surprises Act, which REACH alleged was based on fraud. 
    • “Lower courts have split on whether doctors and insurers can sue to enforce or overturn the awards outside of a limited set of circumstances outlined in the law.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19 infections are also growing or likely growing in 20 states. The agency said it would begin tracking respiratory syncytial virus trends soon.” 
  • The Wall Street Journal relates,
    • “Tens of thousands of kids who take prescription ADHD medication also wind up on other powerful psychotropic drugs—including antipsychotics and antidepressants, studies show. For some of them, the ADHD drugs themselves can be a trigger, according to doctors, patients and psychologists, who say additional medications are often prescribed to manage side effects such as insomnia, despite limited scientific evidence supporting these combinations in young, developing brains. 
    • About 7.1 million American children ages 3 to 17 have an ADHD diagnosis, according to an analysis of 2022 federal data. About half took ADHD medication for it that year, and prescriptions are growing. 
    • “The decision to treat ADHD with medication is often made by desperate parents trying to keep their kids from falling behind or being kicked out of school or daycare, parents and mental health clinicians say. For preschool-age kids, the drugs are often dispensed against pediatric guidelines, which call first for behavioral therapy, a treatment that can be hard to get. And mental health providers say the drugs are frequently prescribed to treat childhood trauma that has been misdiagnosed as ADHD.
    • “For one in five kids who take them, ADHD drugs are just the beginning. A Wall Street Journal analysis of Medicaid data from 2019 through 2023 shows that children who were prescribed a medication for ADHD were far more likely to take additional psychiatric drugs over the ensuing four years.”
  • Per Health Day,
    • “Long COVID can follow one of eight different symptom paths, as patients suffer for months past their initial infection, a new study reports.
    • “The eight identified “trajectories” show how long COVID can differ between patients based on its severity and duration, as well as whether their symptoms improve or worsen over time, researchers reported Nov. 17 in the journal Nature Communications.
    • “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” lead researcher Tanayott Thaweethai, an assistant professor at Harvard Medical School and associate director of Massachusetts General Hospital Biostatistics in Boston, said in a news release.”
  • Per MedPage Today,
    • “Higher physical activity in midlife was associated with a 40% lower dementia risk over 26 years.
    • “Late-life physical activity also was linked with less dementia risk.
    • “Exercise and activity can increase cerebral blood flow, reduce inflammation, and boost neuroplasticity.’
  • Per Genetic Engineering and Biotechnology News,
    • “A new paper from the laboratory of David Liu, PhD, at the Broad Institute describes a genome-editing strategy that could result in a one-time treatment for multiple unrelated genetic diseases. The new technique dubbed prime editing-mediated readthrough of premature termination codons or PERT is detailed in Nature in a new paper titled “Prime editing-installed suppressor tRNAs for disease-agnostic genome editing.” The work is spearheaded by co-first authors Sarah Pierce, PhD, and Steven Erwood, PhD, both of whom are postdoctoral associates in the Liu lab.  
    • “According to its developers, PERT is designed to maximize the potential of gene editing by using a single agent to target multiple disorders. Specifically, it uses prime editing, also developed by the Liu lab, to rescue nonsense mutations, which, when they appear, cause cells to stop protein synthesis early, resulting in malfunctional forms of proteins that are linked to various rare diseases.
    • “Importantly, PERT does not directly edit nonsense mutations, which account for 24 percent of pathogenic alleles in the ClinVar database. It works by “permanently converting a dispensable endogenous tRNA into an optimized [suppressor]-RNA.” This conversion equips edited cells to produce functional forms of the necessary protein, regardless of which gene has the mutation.” 

From the U.S. public health business front,

  • Fierce Healthcare reports,
    • “The average amounts of a hospital’s denied inpatient and outpatient claims have increased by 12% and 14%, respectively, with greater denial volumes also accompanying an uptick in payer’s audits, according to a vendor report released this week. 
    • “The analysis, which looked at real-world data from the first three quarters of 2025 among MDaudit’s network of more than 1.2 million providers and 4,500 facilities, echoes reports from health system executives and management teams describing heightened payer denial activity as a drag on their revenues.
    • “Specifically, for external payer audits, the billing compliance and revenue integrity tech platform said it spotted a 30% year-over-year increase per customer in total at-risk amount.
    • “The average amount per claim also rose by 18%, according to the report. Among these, 45% of the at-risk amount came from commercial payers with Medicare and Medicaid accounting for 28%.”
  • Beckers Payer Issues informs us,
    • “More and more payers and employers have been getting on board with surgical alternatives to GLP-1s for weight loss.
    • “A 2024 survey found most employer-sponsored plans covered these procedures, and covering GLP-1s for diabetes and obesity was much less likely. KFF reported that the majority of organizations with at least 5,000 employees said covering GLP-1 agonists had a “significant” impact on prescription drug spending.
    • “One doctor told Becker’s that insurers see “more reliable outcomes and savings” when they pay for bariatric surgery. During a panel on GLP-1s at Becker’s Fall 2025 Payer Issues Roundtable this month, Select Health Senior Medical Director Kenny Bramwell, MD, echoed that sentiment.
    • “A handful of years ago, I never would have said this, but some people may need to consider — or we need to at least consider — the costs of surgical options,” Dr. Bramwell said. “Bariatric surgery suddenly seems inexpensive compared to $1,000 a month in perpetuity.”
    • The article considers whether recent GLP-1 drug price reductions may change perspectives.
  • Per MedTech Dive,
    • “Abbott has agreed to acquire cancer test-maker Exact Sciences for about $21 billion.
    • “Exact Sciences makes the Cologuard noninvasive screening test for colorectal cancer. The company also makes tests to detect multiple types of cancer early and identify molecular residual disease to assess the risk of recurrence. 
    • ‘The deal is expected to close in the second quarter of 2026, subject to shareholder and regulatory approvals. Abbott expects Exact Sciences to generate more than $3 billion in revenue this year and grow Abbott’s total diagnostics sales to more than $12 billion annually after the acquisition closes.”
  • Per Biopharma Dive,
    • “Biotechnology company Moderna said Thursday it has secured a loan of $1.5 billion as it reevaluates its pipeline in an effort to break even by 2028.
    • ‘The vaccine maker signed a five-year loan facility with Ares Management Credit Funds, a move Chief Financial Officer Jamey Mock said, in a statement, will enable “increased flexibility over the coming years.” The influx of capital provides an additional lifeline as the drugmaker navigates a post-pandemic market.
    • ‘Moderna also announced a three-year business strategy, targeting up to 10% revenue growth in 2026. Company shares subsequently rose over 2%.”
  • Chief Health Executive reports,
    • “Bob Farrell says health plans and providers have plenty of data on their patients, but they’re not always getting the most of it.
    • “Farrell is the CEO of mPulse, a company working with health systems and health plans to get more insights on their patients. The company has been growing significantly in recent years, completing the acquisition of Clarity Software Solutions over the summer. Clarity is the fifth company mPulse has acquired since December 2021.
    • “With the addition of Clarity, Farrell says the goal is to use AI technology to “provide a plan or a provider with a 360-degree view of their members or their patients.”
    • “With that information, he says, “They can do the things that allow that member or patient to really take charge of their health care, and ultimately to improve outcomes, while simultaneously driving efficiencies for the plan or the provider themselves.”
    • “The company works with 450 healthcare organizations and 50 of the nation’s 60 largest health plans.”

Midweek update

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

From Washington, DC

  • Roll Call reports,
    • “GOP health panel leaders in the Senate on Wednesday seemed intent on quickly implementing a health savings account proposal to replace expiring health care tax credits that subsidize insurance plans used by millions of Americans, despite increased skepticism from Democrats and even some House Republicans.
    • During a Senate Finance Committee hearing on health care affordability, lawmakers largely stuck to party-line questioning over skyrocketing costs for Affordable Care Act health plans, suggesting no easy compromise is imminent.”
  • Fierce Healthcare tells us,
    • “Democrats didn’t necessarily discount their counterparts’ ideas during the hearing but said lawmakers need to extend the subsidies as-is for at least one year to allow for significant time to actually have a back-and-forth on healthcare policy and for those policies to be implemented.” * * *
    • “Ranking member Ron Wyden, D-Ore,, said that once a “clean” extension is in place, he and his Democratic colleagues would gladly join Republicans in curbing “insurance company abuses.” That extends to a long-discussed reform of the pharmacy benefit management industry, he said.”
  • The American Hospital Association News informs us,
    • “The House Ways and Means Subcommittee on Health held a hearing Nov. 19 to discuss improvements to care coordination and delivery to prevent and treat chronic disease. Health care and pharmaceutical experts testified before the committee, including Michael Hoben, M.D., chief medical officer of population health services at Novant Health.” 
  • Roll Call adds,
    • “Congress’ schedule for next year is set after the Senate rolled out its 2026 calendar Wednesday, a day after the House unveiled its own version. 
    • “The Senate calendar, made public by Majority Leader John Thune’s office, contains a few notable differences from the schedule set by the House for the midterm election year.”
    • The article identifies those differences. 
  • Per a U.S. Office of Personnel Management news release,
    • “The U.S. Office of Personnel Management (OPM) today issued a memo to agencies announcing the launch of two new executive development programs: the Senior Executive Development Program (SEDP) and Leadership for an Efficient and Accountable Government (LEAG). These programs aim to equip Senior Executives, Senior Professionals, GS-15s, GS-14s, and their non-Title 5 equivalents with the skills and knowledge to advance the administration’s priorities and drive transformational change across federal agencies.” * * *
    • “These programs are a bold step toward building a federal workforce that is agile, accountable, and ready to deliver results for the American people,” OPM Director Scott Kupor said. “By investing in our leaders, we’re ensuring they have the tools to advance President Trump’s vision for a more efficient and effective government.”
    • “Read the memo here.”
  • Kevin Moss, writing in Govexec, offers Open Season advice for annuitants.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Just a few months after Boehringer Ingelheim broke into the oncology space with the first drug that can target a rare tumor type in patients with non-small cell lung cancer (NSCLC), the FDA has given its stamp of approval to a competitor in Bayer’s Hyrnuo (sevabertinib).
    • “Hyrnuo, a tyrosine kinase inhibitor (TKI), is specifically indicated for patients who have previously received treatment for nonsquamous NSCLC and whose tumors are confirmed to have relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).
    • “The twice-daily oral med was cleared through the FDA’s accelerated approval pathway, meaning it still needs to prove its worth in a confirmatory study. Nonetheless, the FDA saw preliminary evidence of clinical benefit in Bayer’s phase 1/2 Soho-01 trial.”
  • Per Radiology Business,
    • “The U.S. Food and Drug Administration has just granted De Novo marketing authorization for an at-home prenatal ultrasound platform that allows patients to scan themselves. 
    • “Israel-based Pulsenmore Ltd. announced the authorization for its Pulsenmore ES on Monday [November 3]. The product is an at-home prenatal ultrasound system physicians can prescribe to women so they can scan themselves under remote guidance via in-app instructions or a physician. Images captured are transmitted securely to the Pulsenmore app, where the provider can read them and inform the patient of any findings that might warrant an in-person visit. 
    • “Experts are hopeful the complementary tool can expand access to vital prenatal care, offering expectant mothers an added layer of reassurance.” * * *
    • “Learn more about the system here.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “A pair of new Pew Research Center surveys finds that while nearly two-thirds of US adults view childhood vaccines as effective, confidence in their safety and in vaccine policy is increasingly shaped by political affiliation. At the same time, changes to federal COVID-19 vaccine recommendations appear to have had little impact on willingness to receive an updated shot. 
    • “In a nationally representative survey of more than 5,100 adults, 63% say they are extremely or very confident that routine childhood vaccines are effective at preventing serious illness.” * * *
    • “A separate Pew survey examined whether recent changes to US Centers for Disease Control and Prevention (CDC) vaccine guidelines have influenced Americans’ decisions to receive an updated COVID-19 vaccine. 
    • “According to the survey, the new recommendations have had little effect on public uptake. A majority of adults (59%) say they do not plan to receive the updated vaccine, similar to 2024 levels. Thirteen percent of respondents had already received the vaccine as of late October, and just 26% say they want to get it.”
  • and
    • “The results of a large clinical trial, published today in the New England Journal of Medicine, show that researchers are making progress on experimental mRNA flu shots, even if they aren’t yet ready to be rolled out to consumers.
    • “In the study, people randomly assigned to receive a flu shot made with modified mRNA were 29% less likely to be diagnosed with a lab-confirmed case of influenza by the end of winter than people given a conventional flu shot.
    • “The experimental mRNA vaccine prevented 60% to 67% of flu infections, while the conventional vaccine prevented 44% to 54% of infections, said Kelly Lindert, MD, vice president of clinical research and development at Pfizer and senior author of the new study.
    • “Authors of the study, which was funded by Pfizer, tested the experimental mRNA vaccine in more than 18,000 adults age 18 to 64 during the 2022-2023 flu season.
    • “This really is exciting and promising,” said Bill Hanage, PhD, a professor of epidemiology at the Harvard T.H. Chan School of Public Health., who was not involved in the new study. The modified mRNA vaccine “is plainly capable of protecting for at least a season and doing so better than the one with which it was being compared.”  * * *
    • “Mild to moderate side effects were much more common in those who received the mRNA shot, however.
    • “Researchers will need to reduce the number of side effects to make mRNA shots palatable, Hanage said.
    • “While there’s no evidence of an excess of really serious adverse events, there are clearly more of the moderate and not-pleasant adverse events,” Hanage said. “For many folks, this has been their dominant memory of COVID shots, and people will be reluctant to get vaccines on an annual basis which make them feel rotten.”
  • Yale New Haven Health System discusses what causes lung cancer in non-smokers.
  • JAMA Network lets us know,
    • “Annual lung cancer screening (LCS) reduces LC mortality and is recommended by the US Preventive Services Task Force (USPSTF). Recent state-level data showed LCS uptake is low (9%-31%), but true nationally representative estimates are lacking. This study estimated the current national prevalence of up-to-date LCS and deaths prevented and life-years gained from LCS at current and 100% screening uptake.” * * *
    • “Only approximately 1 in 5 eligible individuals in the US underwent LCS in 2024. Increasing current uptake to 100% could increase deaths prevented and life-years gained 3-fold. Efforts to increase uptake include improving awareness of LCS recommendations and access to LCS facilities, and targeting subgroups in whom LCS maximizes life-years gained. Unscreened eligible individuals in this study with fewer comorbidities had similar life-years gained because they were less likely to die of comorbid causes. Revisiting current eligibility recommendations is warranted. In 2023, the American Cancer Society eliminated the years-since-quit requirement and the National Comprehensive Cancer Network followed suit in 2025″
  • Per Cardiovascular Business,
    • “Financial incentives appear to double consistent hypertension medication use, according to a study led by NYU Langone Health and presented as a late-breaker at the American Heart Association (AHA) 2025 Scientific Sessions.
    • “Financial incentives clearly worked during the study—people in the rewards group took their medication much more consistently,” said John A. Dodson, MD, MPH, principal investigator and lead author of the study in a statement. Dodson is the director of NYU Langone’s Geriatric Cardiology Program and an associate professor in the Department of Medicine’s Leon H. Charney Division of Cardiology at NYU Langone Health.” * * *
    • “Researchers found that about 71% of patients in the rewards group opened their blood pressure medication on 80% of days. But the control group only opened the bottles on about 34% of days. Interestingly, both groups saw similar drops in blood pressure, with average systolic pressure falling by 6.7 mm Hg in the rewards group and 5.8 mm Hg in the control group.
    • “We were surprised that this didn’t lead to significantly better blood pressure control,” Dodson said. “It’s unclear whether participants opened the bottles without taking the medication, or if other untracked factors, like different medications or lifestyle behavior, affected their blood pressure.”
    • “Also, once the rewards ended, so did improvements in blood pressure, as medication habits returned to pre-study noncompliance levels.
    • “Dodson said the team was also surprised that adherence to medication dropped when the rewards ended. He said this shows how complex behavior change really is.”
  • Incentives can be complicated.
  • Per Health Day,
    • “The risk for hearing loss is significantly higher for patients with type 2 diabetes versus controls, according to a review published in the November issue of Otolaryngology-Head and Neck Surgery.”
  • Per MedPage Today,
    • “Overall cesarean birth rates decreased from 2012 to 2021, but racial disparities for Black women widened.
    • “Cesarean delivery can be vital but can also contribute to undue morbidity and mortality.
    • “Strategies to target racial disparities in cesarean delivery are warranted.”
  • Genetic Engineering and Biotechnology News relates,
    • “Typically, bone marrow research relies heavily on animal models and oversimplified cell cultures in the laboratory. Now, researchers from the Department of Biomedicine at the University of Basel and University Hospital Basel have developed a realistic model of bone marrow engineered entirely from human cells. Derived using human induced pluripotent stem cells (hiPSCs) and macro-scale porous hydroxyapatite scaffolds, the engineered vascularized osteoblastic niche (eVON) model may become a valuable tool not only for blood cancer research, but also for drug testing and potentially for personalized therapies. The researchers suggest the novel system could reduce the need for animal experiments for many applications.
    • “The research team, headed by Professor Ivan Martin, PhD, and Andrés García-García, PhD, reported on their achievement in Cell Stem Cell. In their paper, titled “Macro-scale, scaffold-assisted model of the human bone marrow endosteal niche using hiPSC-vascularized osteoblastic organoids,” the team stated, “The described eVON model addresses some of the current limitations in the development of uniform, durable, and reproducible human organoids toward enhanced relevance in disease modeling and drug screening.”
  • Per an NIH news release,
    • “Researchers gained new insights into the changes in the brains of young athletes that may lead to chronic traumatic encephalopathy. 
    • “The findings suggest that repetitive head impacts cause brain changes much earlier than previously thought.” 
  • Fierce Pharma informs us,
    • “In its mission to grow the reach of its pyruvate kinase (PK) activator Pyrukynd (mitapivat), Agios Pharmaceuticals has come up short of producing an unequivocal win in the key indication of sickle cell disease (SCD).
    • “Attempting to capture a “broad assessment” of the potential benefits of the drug across “multiple aspects of the disease,” the company ran the 52-week Rise Up study, with primary endpoints assessing hemoglobin responses and the annualized rate of sickle cell pain crises (SCPCs) compared to placebo. The study further examined five secondary endpoints, including other biomarker responses, patient fatigue and the annualized rate of hospitalizations for SCPCs.
    • “Rise Up met one primary endpoint by demonstrating an improved hemoglobin response, Agios said on Wednesday, with 40.6% of patients on the drug meeting hemoglobin response criteria, versus 2.9% on placebo. On the other primary measure, however, Pyrukynd showed a “reduction” in SCPCs but did not ultimately achieve statistical significance.”

From the U.S. public health front,

  • MedCity News explains how forward-thinking health plans are designing utilization management systems that are clinically sound, operationally efficient, and aligned with enterprise goals.
  • Healthcare Dive reports,
    • “Cleveland Clinic finished the quarter ended Sept. 30 on a high note, growing its operating income more than 375% year over year to total $206.2 million.
    • “Total revenue climbed to $4.5 billion, fueled largely by higher patient volumes, strong demand for outpatient services and favorable Medicare Advantage delegated premium and risk agreements that took effect at the beginning of the year. 
    • ‘Still, like many of its peers, the Ohio-based academic medical center is contending with rising costs. Operating expenses rose 10.2% year over year to total $4.1 billion as inflation and higher patient volumes pushed up spending on labor and pharmaceuticals.” 
  • Per Beckers Hospital Review,
    • “New York City-based NYU Langone Health reported an operating income of $482.8 million on $15.4 billion in revenue for the fiscal year ended Aug. 31, 2025, maintaining a steady operating margin of 3.1%, according to financial documents published Nov. 17.
    • “The financial results represent a 9.6% increase in operating revenue compared to the prior year, when the seven-hospital system posted a $431.4 million operating gain on $14 billion in revenue. Growth was driven by a 5% increase in inpatient discharges, a 10.8% increase in outpatient surgical volume and a 3.4% rise in emergency department visits, according to the system.”
  • Per Fierce Pharma,
    • “Facing the fact that Lundbeck’s unexpected offer for Avadel Pharmaceuticals was sweeter, Alkermes has come back to the negotiating table with a higher bid it believes can seal the deal.
    • “Alkermes and Avadel have reached an accord on a new offer that would see Alkermes pay up to $22.50 per Avadel share to acquire the company, according to a Nov. 19 press release. The upgraded bid features $21 per Avadel share in cash as well as a $1.50 per share contingent value right (CVR) tied to the potential FDA approval of Avadel’s narcolepsy drug Lumryz in idiopathic hypersomnia by the end of 2028.
    • “All told, the souped-up bid values Avadel at $2.37 billion, contingent upon the Lumryz milestone paying out, Alkermes said in its release.”
  • and
    • “Amid the pharma industry’s breakneck onshoring push this past year, North Carolina has been a major beneficiary as investment announcements rolled in from the likes of Roche, Biogen and Amgen. Now, Novartis is ready to significantly boost its presence in the state.
    • “Wednesday, the Swiss pharma giant rolled out a plan to establish a “flagship manufacturing hub” in the Tar Heel State. While Novartis already operates a gene therapy production site in Durham, the company plans to expand that site and add two more in the same city. In addition, Novartis plans to establish a new plant in Morrisville, North Carolina, the company said in a Nov. 19 announcement.
    • “Specifically, the company plans to build two new facilities in Durham for biologics and sterile packaging, according to the release. Novartis’ new site in Morrisville will specialize in solid dosage tablets and capsules, including packaging capabilities.”
  • and
    • “With a $140 million investment, Moderna will bring its drug product manufacturing to the United States, joining a parade of drugmakers looking to strengthen their supply chains and reduce exposure to potential tariffs on U.S. pharmaceutical imports. 
    • “Moderna’s project centers on the buildout of a new facility at its manufacturing campus in Norwood, Massachusetts, 20 miles south of its headquarters in Cambridge. The new plant will allow the company to execute end-to-end clinical and commercial stage production of its mRNA medicines. 
    • “By onshoring drug product manufacturing to our campus in Norwood, Massachusetts, we have completed the full manufacturing loop under one roof in the U.S.,” Moderna CEO Stéphane Bancel said in a Nov. 19 press release. “As an American company committed to building and producing in America, we are proud to strengthen our domestic footprint while bringing meaningful new jobs to the community.”

From the artificial intelligence front,

  • Beckers Health IT identifies ten “big” AI themes for healthcare as we head toward 2026.
  • MedTech Dive reports,
    • “Philips said Monday it has collaborated with Edwards Lifesciences to develop a tool that uses artificial intelligence to help physicians visualize and navigate mitral transcatheter edge-to-edge repair, or TEER, procedures.
    • “Called DeviceGuide, the technology tracks the repair device in real time as it moves through the heart. Philips said the system marks a shift in the use of AI from diagnostic imaging and patient monitoring into support for clinical decision-making during live procedures.
    • “DeviceGuide is available in some European markets through a limited release and has been submitted to the Food and Drug Administration for review, a Philips spokesperson said in an email.”

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “President Trump said he is talking with Democrats about a direct health care payment plan Sunday amid negotiations to tackle rising health insurance premiums. 
    • “I’ve had personal talks with some Democrats,” Trump told reporters in West Palm Beach, Fla., on Sunday before returning to Washington. 
  • STAT News adds,
    • “Sen. Bill Cassidy (R-La.) is pitching Democrats on his compromise to make Affordable Care Act marketplace plans affordable without extending the extra tax credits that currently lower premium payments.
    • “Cassidy, the chair of the Senate health committee, is among the team of Republican senators picked to negotiate with Democrats on the credits in preparation for a mid-December vote. Republicans agreed to the vote in exchange for Democrats’ support to reopen the government. 
    • “Cassidy’s plan is not the official Republican plan, but he said his proposal is in line with the thinking of his GOP colleagues. Its structure jibes with President Trump’s demand to end the extra federal subsidies for ACA insurance and instead give an equal amount of cash directly to people to spend on health care. 
    • “The crux of Cassidy’s plan is to fund health savings accounts with money that currently goes toward the enhanced premium tax credits. His plan would not affect the original ACA premium tax credits. It would only apply to the extra, pandemic-era credits that expire at the end of the year. Cassidy described his plan to reporters during a briefing on Monday but has not yet released corresponding legislation.
    • “Cassidy’s proposal is for these HSAs to accompany ACA bronze plans. Trump’s tax bill changed the rules so that all bronze plans are eligible for HSAs, starting Jan. 1.
    • “Cassidy said he has not yet figured out how to allocate the HSA subsidies to enrollees, which could be complicated.
    • “Bronze plans have the lowest premiums among the three metal-tier plans and the highest cost sharing. Premiums vary significantly by state, but the average lowest monthly bronze plan premium is $456 and the average lowest silver premium is $611, before any subsidies, according to KFF.” 
  • Roll Call provides an overview of Congressional activities this week.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Nov. 14 released preliminary guidance to states on implementing provider tax provisions in the One Big Beautiful Bill Act. CMS clarified the meaning of “enacted” and “imposed” for purposes of section 71115, which establishes new indirect hold harmless thresholds effective Oct. 1, 2026. A tax is considered enacted when the legislative process authorizing the tax is fully completed and any required waiver is approved by CMS as of July 4, 2025. A tax is imposed when the state or locality was actively collecting revenue under that tax structure on the same date. These definitions establish that only taxes in effect as of July 4, 2025, are included in the new indirect hold harmless threshold, effectively prohibiting new or increased provider taxes beyond those limits. 
    • “CMS also addressed transition periods under section 71117, which specified circumstances in which a provider tax is not considered generally redistributive and therefore noncompliant. States with noncompliant managed care organization taxes approved before July 4, 2025, have until the end of their fiscal year ending in 2026 to comply, while other affected provider taxes have until the end of the fiscal year ending in 2028, but no later than Oct. 1, 2028. CMS emphasized that these transition periods are intended to allow states to prioritize compliance while maintaining Medicaid fiscal integrity and will be finalized through notice-and-comment rulemaking.” 
  • Federal News Network interviews an OPM official Holly Schumann and Consumer Checkbook’s director Kevin Moss about the ongoing Federal Benefits Open Season.
  • The Wall Street Journal informs us,
    • “The Federal Aviation Administration said it would lift its flight restrictions related to the government shutdown, clearing the way for normal operations to resume at U.S. airports after weeks of delays and cancellations. 
    • “Transportation Secretary Sean Duffy and FAA Administrator Bryan Bedford said Sunday that the 6% traffic cut implemented last week would be terminated at 6 a.m. ET Monday morning. They said the move came after the FAA reviewed safety trends and saw improving staffing levels.
    • “Now we can refocus our efforts on surging controller hiring and building the brand new, state of the art air-traffic control system the American people deserve,” Duffy said.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics.
    • “People living with [spinal cord injuries] will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes,” said CEO Dave Marver in a press release.”
  • Per Fierce Pharma,
    • “The clock is up on Biogen’s extra two years of a biosimilar-free U.S. market for its blockbuster multiple sclerosis (MS) med Tysabri. After waiting in the wings post-FDA approval in 2023, Sandoz’s biosimilar rival Tyruko has officially launched in the U.S.
    • “Tyruko is not only the first Tysabri biosimilar, but it’s also the first U.S. biosimilar that can treat multiple sclerosis. The launch marks an “important opportunity to help people with MS navigate this disease in a way that is more cost-effective,” Sandoz’s North America president Keren Haruvi explained in the company’s Nov. 17 press release. 
    • “Sandoz pinned its name on the drug through a global commercialization agreement with Polpharma Biologics in 2019, which developed Tyruko and handles manufacturing and supply. The biosimilar is also available in 14 European countries and is expected to be a “key contributor to the Sandoz growth strategy,” according to its release, fitting into the company’s ambitions to be “#1 in biosimilars in the US and a leader in the treatment of MS globally.”
  • Per MedTech Dive,
    • Zimmer Biomet said Friday [November 14] that it has received 510(k) clearance for an updated version of its Rosa knee surgery robot.
    • The Food and Drug Administration clearance covers Rosa Knee with Optimize. Compared to the older system, Zimmer has simplified the user interface and streamlined the surgical workflow.
    • Zimmer CEO Ivan Tornos predicted at investor events earlier this year that the new system would accelerate Rosa installs and be a “meaningful contributor” to sales in 2026.

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “A Washington state resident has contracted a bird flu strain previously only found in animals, health officials confirmed Nov. 14. 
    • “The individual has been hospitalized since early November with influenza H5N5, an avian influenza strain never before reported in humans, according to the Washington State Department of Health. The patient is an older adult with underlying health conditions who has a “mixed backyard flock of domestic poultry at home that had exposure to wild birds,” officials said, adding the animals likely exposed the virus to the individual but an investigation is ongoing. 
    • “The CDC said the risk to the public remains low. 
    • “As of Nov. 14, the CDC has confirmed 71 cases of human bird flu and one death. The most common strain in animals and humans is H5N1. Richard Webby, PhD, a virologist and influenza expert at St. Jude’s Children Research Hospital in Memphis, Tenn., told The Washington Post the H5N5 strain behaves similarly to H5N1 in models.” 
  • The American Medical Association lets us know what doctors wish older adults knew about physical activity.
    • “From aerobics to balance workouts for seniors, it’s key to find a physical activity that works as you age. Two Northwell Health physicians share more.”
  • Parkinsons News Today points out,
    • “Frequently eating sweets, red meat, and processed meats appears to increase the risk of developing Parkinson’s disease, while consuming more fruits — especially citrus — may be protective against it, according to a large study from Italy.
    • “The researchers found, however, that certain nondietary influences were more strongly linked to the risk of Parkinson’s than eating habits. Key among these, the team noted, were family history, digestive problems, and exposure to pesticides, oils, metals, and general anesthesia.
    • “This study suggests that eating habits might have some impact on [Parkinson’s disease], but they are not the main cause,” the scientists wrote. “Future research should look at both diet and other lifestyle habits to better understand how to prevent [Parkinson’s].”
    • “The study, “The impact of diet on Parkinson’s disease risk: A data-driven analysis in a large Italian case-control population,” was published in the Journal of Parkinson’s Disease.”
  • Per Health Day,
    • “Want to avoid migraines? Stick to your boring routine, a new study suggests.
    • “Any major disruption to a person’s daily routine — called a “surprisal” event — is strongly linked to a higher risk of a migraine attack within the next 12 to 24 hours, researchers reported Nov. 11 in JAMA Network Open.
    • “Too much food or drink, staying up late, a stressful incident, unexpected good or bad news or a severe mood swing could pose a “surprise” to the body, setting it up for a next-day migraine, researchers said.
    • “Incorporating measurement of surprisal into migraine forecasting tools could provide individuals with a more effective, personalized strategy for managing headache risk,” concluded the research team led by Dana Turner, an assistant professor of anesthesia, critical care and pain medicine at Harvard Medical School.
    • “In fact, the findings support a person-centered approach to treating a migraine “that moves beyond static lists of potential causes to account for the unpredictable and context-sensitive nature of daily life.”
  • Per Medscape,
    • “More than half of the people who stop using GLP-1 drugs regain at least some of the weight within a year, new real-world data showed.
    • “The new findings, from a large national claims database, “corroborate the clinical trial data that treatment discontinuation leads to weight recurrence. Optimizing and personalizing the approach toward treating obesity and maximizing gastrointestinal tolerability will maximize long-term use and long-term benefits of weight reduction,” study author Michael A. Weintraub, MD, an endocrinologist at New York University Langone Health, New York City, told Medscape Medical News.
    • “Weintraub reported the data on November 5, 2025, at Obesity Week 2025. “Treatment discontinuation leads to weight recurrence in clinical trials, but few real-world studies have evaluated this issue,” Weintraub said in his introduction.”
  • Medscape also shares insights about “Breakthrough Therapies in Chronic Kidney Disease.”
  • Genetic Engineering and BioTechnology News relates,
    • “The human papillomavirus (HPV) vaccine is a triumph of modern medicine—but it cannot eliminate an existing infection. Once HPV takes hold, no approved vaccines can stop its progression to cervical cancer, leaving surgery and chemotherapy as the main options. Researchers at Chiba University are working to change that with a nanogel nasal vaccine that shows promise in preclinical models.
    • “The study, led by associate professor Rika Nakahashi-Ouchida, MD, and Hiromi Mori of Chiba University Hospital, was published in Science Translational Medicine. The paper, titled “Cationic nanogel–based nasal therapeutic HPV vaccine prevents the development of cervical cancer,” describes a vaccine that activates local immune responses and slows tumor growth in animal models.
  • STAT News reports,
    • “The biotechnology firm Nuvalent said Monday that its drug for a genetically defined type of lung cancer shrank tumors in more than a quarter of patients whose disease had returned after trying other targeted medicines, and that the response endured in most of those people for at least a year.
    • “According to the company and an analyst who follows it, the results could mean that the medicine might be approved quickly and adopted by patients and doctors who might prefer it based on its efficacy and side effect profile to existing treatments for this type of lung cancer, which is caused by alterations in a gene called ALK (anaplastic lymphoma kinase).”
  • Per Fierce Pharma,
    • “Nearly three years after striking up a Zymeworks licensing pact with an eye on challenging the status quo in HER2-positive cancers, Jazz Pharmaceuticals is seeing its vision with Ziihera come into clearer focus.
    • “In a press release Monday, Jazz described a positive phase 3 readout as boosting its confidence that it has a HER2-targeted “agent-of-choice” for first-line patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.
    • “For a combination of Ziihera plus chemotherapy and BeOne Medicines’ Tevimbra, Jazz sees a “new standard of care” coming into form.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Health and CVS Health’s Oak Street Health are struggling to adapt to the modified Medicare Advantage risk-adjustment system. 
    • “These healthcare delivery subsidiaries are renegotiating insurance contracts to offset dwindling Medicare Advantage revenue.
    • “Optum Health and Oak Street Health are disproportionately reliant on reimbursements from their parent companies’ insurance arms, UnitedHealthcare and Aetna.”
  • and
    • “GoodRx is the latest telehealth company to launch a subscription weight loss program.
    • “GoodRx’s subscription program will initially start at $39 per month before going up to $119 per month in February, the company said in a release.”
  • The American Medical Association News tells us,
    • “The AHA Nov. 17 released Fast Facts: Is My Hospital Rural, featuring updated information on the important role rural hospitals play in their communities, the people they serve and the challenges they face. The infographic features updated information on the important role rural hospitals play, the people they serve and the challenges they face. The infographic is being released before National Rural Health Day on Thursday, Nov. 20.”
  • Per MedTech Dive,
    • “Boston Scientific and Siemens Healthineers have partnered to develop and commercialize Siemens Healthineers’ next-generation intracardiac echocardiography catheter, the companies said Thursday.
    • “The new cardiac imaging catheter is intended for use in structural heart procedures, including standalone Watchman left atrial appendage closure, Farapulse pulsed field ablation, and the Farawatch approach combining PFA with the Watchman implant. 
    • “Boston Scientific expects the agreement to encourage adoption of its Watchman device by more sites, furthering growth of an already successful business. Boston Scientific will become the exclusive distributor of the Acunav 4D ICE catheter in the U.S. and Japan, once the device is commercially available.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Health tech investor the SymphonyAI Group aims to leverage the best of both companies’ AI expertise to expand its reach among health systems.
    • “RhythmX AI and Get Well, two companies under the SAI Group’s banner, have merged to form GW RhythmX, the investor announced last week. The combined company already has broad reach in the healthcare market. It currently serves 150 health systems, SAI Group said in a press release.
    • “The companies’ combined capabilities will engage patients and help them navigate the healthcare system, while delivering personalized insights to physicians at the point of care, according to the investor in a press release.
    • “The former standalone company RhythmX AI is a personalized care platform that supports physician decision-making and boosts physician productivity by providing AI-powered care recommendations tailored to the patient. The platform also helps proactively manage patient care by identifying at-risk patients and projecting disease progression. It also routes patients to the right clinician at the right time.” 
  • Beckers Health IT informs us,
    • “Patients are increasingly turning to AI chatbots for health information, driven by long wait times, high healthcare costs and dissatisfaction with clinical interactions, The New York Times reported Nov. 16.
    • “About 17% of adults said they use AI chatbots at least once a month for health information and advice, according to a 2024 KFF poll. This figure increased to 25% among adults under age 30. 
    • “The Times interviewed dozens of patients about their chatbot use, many of whom reported the technology as a more responsive and accessible alternative to their physicians.” * * *
    • “While chatbots can help improve patients’ health literacy and access to timely information, researchers warn that the tools can generate incorrect, overly confident or clinically unsafe advice.
    • “A preprint study from Oxford University found that users rarely made a correct diagnosis or identified appropriate next steps when using ChatGPT to assess symptoms. The study has not yet been peer reviewed.” 

Weekend update

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) hosted health tech leaders at a Health Tech Ecosystem Connectathon event in Washington, D.C., Thursday [November 13, 2025] to showcase progress on its interoperability pledge.
    • “In late July, the CMS and the White House jointly announced a new focus on driving healthcare interoperability and getting health data into Medicare patients’ hands. The push for innovative products that ease health data transfer stems not from regulation, but from voluntary commitments made by industry to uphold new standards set out by the CMS. 
    • “The announcement was sprawling and included several spokes: a new CMS Interoperability Framework and a Health Tech Ecosystem that committed to working on conversational AI, modern digital identity verification and diabetes apps. 
    • “The CMS also committed to improving Medicare beneficiaries’ digital experience with CMS websites.” * * *
    • “The CMS debuted a beta prototype of its new national provider directory, multiple attendees said. The directory will allow Medicare beneficiaries to find providers that accept Medicare and will be available via a free FHIR API. 
    • “One participant noted that the CMS will update the public on its progress online and via a GitHub repository, an open-access cloud repository for projects that also tracks changes.  
    • Multiple companies also demonstrated products that meet the standards set out by the CMS in July for its so-called CMS Aligned Networks.”
  • Federal News Network shares OPM Associate Director for Healthcare and Insurance Shane Stevens views on the Open Season and the FEHB / PSHB program generally.

From the public health and medical / healthcare research front,

  • The Wall Street Journal offers women information about the Food and Drug Administration’s recent removal of a black box warning from all forms of menopausal hormone therapy.
  • Wired reports,
    • “GLP-1s are being studied for a wide range of conditions. Now, scientists will test whether their anti-inflammatory properties can help alleviate symptoms of long Covid.”
  • and
    • “The Aedes aegypti mosquito that can carry dengue, yellow fever, and Zika was thought to be too reliant on a hot and wet climate to survive in the Mountain West. But now, a population is thriving in Western Colorado.
  • The Washington Post adds,
    • “When Susan Akin first started injecting a coveted weight-loss drug early this year, the chaos in her brain quieted. The relentless cravings subsided — only they’d never been for food.
    • “The medication instead dulled her urges for the cocaine and alcohol that caused her to plow her car into a tree, spiral into psychosis and wind up admitted to a high-end addiction treatment center in Delray Beach, Florida.
    • “Doctors at Caron Treatment Centers tried a novel approach for the slender 41-year-old by prescribing her Zepbound, part of a blockbuster class of obesity and diabetes medications known as GLP-1s. Federal regulators have not approved the drugs for behavioral health, but doctors are already prescribing them off-label, encouraged by studies suggesting that they could reshape addiction treatment.
    • “Scientists caution that the research remains nascent. Health insurers do not cover the pricey drugs for that purpose. Addiction specialists say the medications might not be a cure but may work as a tool to quell addictive behaviors.”
  • MedPage Today informs us,
    • “Blood Test May Be a ‘Viable Alternative’ in Liver Cancer Surveillance. Investigational multi-target test more sensitive than ultrasound, but fell short in specificity.
  • The New York Times points out the best foods and drinks to resolve constipation.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health’s operations saw year-over-year improvement for the quarter ended September 30, but the nonprofit health system continues to be weighed down by rising expenses and reimbursement challenges.
    • “Despite strong volume, salary cost management, length-of-stay improvements and higher productivity, CommonSpirit’s financial performance continues to be impacted by expenses growing at a faster pace than revenue,” management said in a press release issued Friday.
    • “A significant impact to the organization’s revenue comes in the form of challenges with payers on denials and timely payments, and payment increases from both government and non-government payers that do not keep up with inflation,” management said.
    • “The 138-hospital system reported an as-recorded operating loss of $396 million (-4.0% operating margin) for the quarter ended September 30, its first fiscal quarter in 2026, as compared to the prior year’s $331 million operating loss (-3.5% operating margin).”
  • and
    • “Maven Clinic is expanding its maternity program to make pregnancy care more precise and personalized.
    • “The expansion includes remote monitoring to identify risks earlier and help address complications. Maven is also adding a NICU program to help get babies home faster through parent preparedness. New features begin rolling out this month.
    • “There’s no typical pregnancy; it’s not a thing. And it’s 2025, and it’s time to not have a cookie-cutter approach,” Neel Shah, M.D., chief medical officer at Maven, told Fierce Healthcare in an advanced interview.
    • “Maven clients trust the company to take care of an entire population, per Shah. That requires providing the right care for the right person, which is now being enabled by a new level of access to data. A year ago, Maven still relied on what members shared about themselves and claims data, Shah said. Now, Maven also has insights from wearables.”
  • Per a November 11, 2025, company news release,
    • “Doc.com, a pioneering healthcare technology company, proudly announces the launch of its new telemedicine platform and services. The platform combines artificial intelligence and blockchain-based technologies to enhance patient access, data security, and care coordination. Through a seamless mobile experience, patients can connect with licensed healthcare professionals within their state to receive quality care conveniently and securely. As part of its introductory rollout, new users may access up to 15 minutes of complimentary teleconsultation, available in eligible jurisdictions and subject to applicable regulations. These minutes may be used across one or multiple sessions as part of an initial trial experience. Subsequent consultations will be available at standard rates.
    • “Doc.com’s United States application rollout begins today with Phase 1 launching in West Virginia, followed by Virginia soon after. The company will then expand to the remaining U.S. states in three additional phases throughout 2026, concluding with full nationwide availability by early 2027. In addition to its United States rollout, Doc.com is introducing a blockchain component, designed to ensure secure, transparent, and efficient transactions across the healthcare ecosystem. This technology supports telemedicine consultations, medical record management, and AI-driven diagnostics, creating a fully integrated platform.”