Tuesday Report

No Surprises Act

Tuesday Report

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

From Washington, DC

  • The American Hospital Association News reports,
    • “President Trump Dec. 1 signed the AHA-supported SUPPORT Act (H.R. 2483) into law. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder. It also includes programs to support the behavioral health workforce.”
  • and
    • “The House Dec. 1 passed the Hospital Inpatient Services Modernization Act (H.R. 4313), legislation extending certain Medicare waivers authorizing the hospital-at-home care program for five years. The AHA expressed support for the bill in September.” 
  • The House Oversight and Government Reform Commitee posted a wrap-up concerning the mark-up session held today and mentioned in yesterday’s FEHBlog.
  • Fierce Healthcare tells us,
    • “Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., is doubling down on his scrutiny of the American Medical Association’s (AMA’s) handling of billing and claims processing codes, telling the professional organization this week that it dodged several of the questions he posed on pricing and other topics back in October.
    • “The senator, a Republican from Louisiana and Congress’ most prominent healthcare legislator, has been putting the screws on the professional association for, in his words, “abusing” its widely adopted Current Procedural Terminology (CPT) coding system with “exorbitant fees” that drive higher healthcare costs.” 
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 2 repealed the minimum staffing requirements for nursing homes that participate in Medicare and Medicaid that the agency adopted in 2024. Specifically, CMS is removing the requirements for nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day. The agency is also removing the requirement for nursing homes to have 24/7 onsite RN services and is reinstating its prior policy requiring facilities to use the services of an RN for at least eight consecutive hours a day, seven days a week and to designate an RN to serve as the director of nursing on a full-time basis except when waived. The facility assessment requirements adopted in the 2024 final rule will remain in place. CMS’ actions are consistent with the budget reconciliation bill enacted in July, which imposed a 10-year implementation and enforcement moratorium on the minimum staffing requirements for long-term care facilities.”
  • Fierce Healthcare points out,
    • “As vaccine policy uncertainty reaches a new level in the U.S., the Centers for Disease Control and Prevention’s (CDC’s) team of vaccine advisors is set to deliberate later this week on childhood immunizations under a new chairman. 
    • “The Advisory Committee on Immunization Practices (ACIP), which was overhauled and repopulated by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over the summer, is set to meet Dec. 4 and Dec. 5. 
    • “On the agenda (PDF) is a vote on hepatitis B vaccines plus discussions on “vaccine safety” and “the childhood and adolescent immunization schedule,” according to a Federal Register notice.” * * *
    • “Stepping up the plate as chairman of the ACIP is Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former U.S. Air Force flight surgeon. Milhoan, one of five new ACIP panelists added to the roster in September, is a senior fellow with the Independent Medical Alliance (IMA) who specializes in treating patients with long COVID and “vaccine-related cardiovascular toxicity,” according to his IMA bio.”

From the Food and Drug Administration front,

  • Fierce BioTech reports,
    • “Mere weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., is taking steps to retire as head of the FDA’s Center for Drug Evaluation and Research, an FDA spokesperson confirmed to Fierce Biotech.
    • “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson said. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
    • “Pazdur has filed papers to retire at the end of this month and informed FDA colleagues of his decision at a Tuesday meeting, according to a report from Stat News.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri.
    • “The seizure focused on foods and dietary supplement products—including liquid shots and tablets—containing concentrated 7-OH as an added ingredient. Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods. These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.
    • “This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must be proactive and vigilant to address emerging threats to our communities and our kids.”
  • Per MedTech Dive,
    • “BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury.
    • “The Food and Drug Administration, which shared details of the letter Friday, has categorized the correction as a Class I recall because of the potential for serious injury or death.
    • “BD paid a $175 million civil penalty last year to settle charges that it misled investors about problems with its Alaris infusion devices and in September recalled pumps with variable performance.” 
  • and
    • “Cleveland Diagnostics said Monday it received Food and Drug Administration approval for a test that analyzes the structure of protein biomarkers in the blood for prostate cancer signals, to aid in determining whether a biopsy is needed.
    • “The IsoPSA technology is for men aged 50 and older whose results from a traditional prostate-specific antigen blood screening showed elevated PSA levels.
    • “Elevated PSA levels can be a sign of prostate cancer, but may be caused by other conditions. The IsoPSA test can help clarify whether a patient with an elevated PSA should have a biopsy procedure or can extend the interval between biopsies, Cleveland Diagnostics Chief Commercial Officer Bob Rochelle said in an interview.”

From the judicial front,

  • Thompson Reuters notes,
    • “The Ninth Circuit has vacated a trial court’s ruling that an insurer acting as a third-party claims administrator (TPA) for self-insured health plans violated Affordable Care Act (ACA) Section 1557 when it administered discriminatory plan exclusions of coverage for gender-affirming care.” * * *
    • “On appeal, the Ninth Circuit ruled that the trial court correctly concluded that the TPA’s provision of health insurance is a health program or activity, part of which is receiving federal financial assistance, and that TPAs can be liable for violating Section 1557 even when implementing plan terms drafted by a plan sponsor. However, the Ninth Circuit ordered the trial court to reconsider its ruling that the gender-affirming care exclusions were discriminatory in light of the U.S. Supreme Court’s Skrmetti decision. (Skrmetti upheld a state’s ban on gender- affirming care for transgender teenagers, reasoning that the ban did not draw classifications based on sex— rather, it prohibited such treatments for certain medical uses with respect to all minors, regardless of sex or gender.) Although the trial court’s reasoning was undercut by Skrmetti, the Ninth Circuit noted that there may be factual distinctions in this case that distinguish it from Skrmetti, such as whether an individual was denied care for a diagnosis other than gender dysphoria or whether discrimination based on a gender dysphoria diagnosis is a pretext for “invidious discrimination” based on transgender status.”
  • The New York Times updates us about New York State’s prosecution of Luigi Mangione who is accused of murdering a United Healthcare executive last December.
    • “Prosecutors have said that Mr. Mangione had personal writings with him at the time in which he denounced America’s for-profit health care system and the “parasites” of the insurance industry. The police also found a journal by Mr. Mangione in his possession that described plans for an assassination, prosecutors said.
    • “Mr. Mangione’s lawyers have argued that the police violated his constitutional rights and so physical evidence taken from his backpack and statements he made at the time should be excluded.
    • “The hearings, which began Monday and are expected to last several days, are the first time Mr. Mangione has appeared in Manhattan state court since the judge overseeing the case, Gregory Carro, threw out terrorism charges against him in September. He still faces second-degree murder and other charges, and if convicted, he could receive a sentence of 25 years to life. Mr. Mangione also faces a federal prosecution.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “Abdominal obesity—the phenomenon commonly known as “beer belly”—is associated with significant cardiovascular risks, according to new data being presented at RSNA 2025 in Chicago.
    • “Abdominal obesity, a high waist-to-hip ratio (WHR), is associated with more concerning cardiac remodeling patterns than high body mass index (BMI) alone,” lead author Jennifer Erley, MD, a radiology resident at University Medical Center Hamburg-Eppendorf in Germany, said in an RSNA statement. “It appears to lead to a potentially pathological form of cardiac remodeling, concentric hypertrophy, where the heart muscle thickens but the overall size of the heart doesn’t increase, leading to smaller cardiac volumes. In fact, the inner chambers become smaller, so the heart holds and pumps less blood. This pattern impairs the heart’s ability to relax properly, which eventually can lead to heart failure.”
  • Health Day relates,
    • “People with severe asthma often take daily steroid medications to help prevent attacks, yet the drugs can bring about serious side effects. Is there another way?
    • “In a new trial, researchers examined how much an add-on treatment, already approved in the United States and United Kingdom, for severe asthma helped people with their symptoms and need for steroid pills.
    • “They found that an injected antibody called tezepelumab allowed 90% of people with severe asthma to reduce their use of daily steroids — and half of patients who received the injection were able to stop taking steroid pills altogether.
    • “Two-thirds of participants in the year-long trial also saw their asthma attacks disappear.
    • “This is an incredibly encouraging development for the future of asthma care that could transform the lives of people with severe asthma,” said Samantha Walker, who directs research at Asthma + Lung UK, a nonprofit advocacy group for people with asthma.”
  • and
    • “Tea, coffee, berries, cocoa, nuts, whole grains, olive oil: They’re all rich in antioxidant compounds called polyphenols, and they’re all good for your heart, a new British study shows.
    • “This research provides strong evidence that regularly including polyphenol-rich foods in your diet is a simple and effective way to support heart health,” said study lead author Yong Li, a PhD candidate in nutrition at Kings College London.
    • “As her team explained, polyphenols are natural compounds that have long been known to be beneficial for heart, brain and gut health.”
  • Per MedPage Today,
    • “A phase III trial of investigational valiltramiprosate (ALZ-801) did not meet its primary endpoint in people with early symptomatic Alzheimer’s disease, but the drug did show benefits in a prespecified population with mild cognitive impairment who carried two copies of APOE4.“
  • and
    • “An mRNA influenza vaccine was approximately 35% more effective than an inactivated quadrivalent flu vaccine against two different strains, based on new data from a phase 3 randomized trial.” * * *
    • “The new data provide compelling evidence that the mRNA platform may protect against influenza, which could be meaningful for future use for both seasonal and pandemic influenza, if warranted, [Kelly] Lindert [M.D., a Pfizer employee] said.
    • “The investigators have identified areas to refine the mRNA influenza vaccine, and they are working to evaluate these candidates in ongoing studies, Lindert told Medscape Medical News. “Our long-term goal is to develop an influenza vaccine that is broadly protective against influenza A and B strains, including protection against severe influenza in children through elderly adults,” she said.”

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

  • McKinsey and Co. explains why “US healthcare organizations should rethink care and business models in response to substantial economic pressures and evolving care demands.”
    • “To address these cost and acuity challenges, healthcare stakeholders should continue to pursue innovative, outcome-focused care models that balance cost and care quality. Four archetypes of outcome-focused care models are in practice today. While these models have demonstrated promise, none have fully realized their potential. In this article, we delve into the value-creating opportunities within the four models:
      • “episodic models focused on shifting sites of care
      • “payer-led models focused on utilization, benefit, and care management
      • “primary care provider (PCP)–led models focused on risk-bearing, value-based care (VBC)
      • “specialty-led models focused on complex disease conditions.”
  • Adam Fein, writing in his Drug Channels blog, opines,
    • “Contrary to popular belief, the Inflation Reduction Act’s (IRA) maximum fair prices (MFPs) could temporarily boost profits for retail pharmacies serving Medicare Part D patients. 
    • “The bad news? The IRA is also one of the five key forces deflating the gross-to-net bubble. 
    • “That’s why any IRA-related pharmacy profits will vanish if manufacturers lower list prices to be closer to net prices. At least 13 brand-name drugs—five of which have MFPs—reportedly plan to reduce list prices within the next two months.
    • “[R]etail pharmacies risk becoming collateral damage from significant deflation in the gross-to-net bubble for drugs subject to an MFP. Welcome to our bonkers healthcare system—where everyone wants lower prices, until they actually get them. 
    • “What’s more, list price cuts will reduce profits from 340B contract pharmacy operations, while weakening covered entities’ main objections to a 340B rebate model. Get ready for a 340B slowdown.”
  • MedCity News considers that “The healthcare industry is contending with a difficult question: how to properly wield AI without taking on too much risk? Inherent in this battle is the role of humans. Here’s how Merck’s chief data officer is viewing AI.” It’s an interesting interview.
  • Healthcare Dive reports,
    • “The share of family physicians working in rural areas decreased 11% from 2017 to 2023, according to a study published this month in the Annals of Family Medicine.
    • “The Northeast saw the greatest loss in rural family physicians over the study period at 15.3%, while the West lost just 3.2% of rural family doctors.
    • ‘The data adds to concerns about physician shortages nationwide. America is expected to need more doctors than ever by 2030 to care for aging Baby Boomers, yet physicians say they’re struggling to hire and retain qualified talent amid high levels of burnout.” 
  • Per Beckers Hospital Review,
    • “Franklin, Tenn.-based Community Health Systems has completed the sale of select ambulatory outreach laboratory assets to Labcorp for $194 million in cash.
    • “The deal includes certain assets of CHS-affiliated hospitals’ lab services in 13 states, such as patient service centers and in-office phlebotomy locations. CHS will retain and continue operating its inpatient and emergency department laboratories, including lab services for hospital-based care like imaging and pre-admission testing.
    • “Completing this transaction with Labcorp allows our health systems to focus on core services and improve the overall patient experience, aligning with our unwavering commitment to providing high-quality, accessible healthcare to our communities,” CHS President and Interim CEO Kevin Hammons said in a Dec. 2 news release. “Labcorp’s scale and investment in technology supports its ability to efficiently deliver outreach laboratory services to patients and healthcare consumers.”

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.” 

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.”

Thursday report

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

From Washington, DC,

  • A copy of the new continuing resolution, H.R. 5371, now Pub. L. No. 119-37 is available on Congress.gov.
  • Section 135 of Pub. L. No. 119-37 reads
    • “Sec. 135. Notwithstanding section 101, the matter preceding the first proviso under the heading “Office of Personnel Management—Salaries and Expenses” in title V of division B of Public Law 118-47 shall be applied by substituting “$197,446,000” for “$219,076,000”, and the second proviso under such heading in such title of such division of such Act shall be applied by substituting “$214,605,000” for “$192,975,000”.
  • The referenced section from Pub. L. No. 118-47, the FY 2024 continuing resolution, reads in pertinent part
    • “For necessary expenses to carry out functions of the Office of Personnel Management (OPM) pursuant to Reorganization Plan Numbered 2 of 1978 and the Civil Service Reform Act of 1978, including services as authorized by 5 U.S.C. 3109; medical examinations performed for veterans by private physicians on a fee basis; rental of conference rooms in the District of Columbia and elsewhere; hire of passenger motor vehicles; not to exceed $2,500 for official reception and representation expenses; and payment of per diem and/or subsistence allowances to employees where Voting Rights Act activities require an employee to remain overnight at his or her post of duty, $219,076,000:” * * * and in addition $192,975,000 for administrative expenses, to be transferred from the appropriate trust funds of OPM without regard to other statutes, including direct procurement of printed materials, for the retirement and insurance programs: * * *”
  • So, Congress essentially flipflopped OPM’s appropriation and available trust fund withdrawal for FY 2026. The appropriation was lowered by approximately $22 million, and the trust fund withdrawal was increased by approximately $22 million for FY 2026.
  • Beckers Hospital Review offers five healthcare notes on Pub. L. No. 119-37
  • Fierce Healthcare adds,
    • “Now that the longest government shutdown in U.S. history has come to an end, healthcare organizations are urging lawmakers to act quickly to extend the enhanced Affordable Care Act subsidies.”
  • OPM has released a November 12, 2025, memorandum to Chief Human Capital Officers about “Employee Pay, Leave, Benefits, and Other Human Resources Programs Affected by the Lapse in Appropriations.”
  • Per Govexec,
    • “A senior administration official told Government Executive that federal HR workers are aiming to get the first post-shutdown checks out to employees within the next week. For many agencies, these paychecks will reflect pay furloughed and excepted workers would have earned from Oct. 1 through Nov. 1.
    • “General Services Administration and Office of Personnel Management employees can expect to see a paycheck Saturday, while Energy, Health and Human Services, Veterans Affairs and Defense Department civilian workers will be paid Sunday. On Monday, paychecks are set to go out for workers at the Education, State, Interior and Transportation departments, as well as the Environmental Protection Agency, NASA, National Science Foundation, Nuclear Regulatory Commission and the Social Security Administration.
    • “Another tranche of workers must wait until Wednesday, Nov. 19, to see their backpay, though their checks will also include pay for the Nov. 2-Nov. 15 biweekly pay period, effectively making them whole for time during the shutdown and paying them for their work between Thursday and Saturday of this week: the Agriculture, Commerce, Homeland Security, Housing and Urban Development, Justice, Labor and Treasury departments, and the Small Business Administration.”
  • Tammy Flanagan, writing in Govexec, explains how federal employees over age 65 can navigate FEHB, Medicare and Tricare. (Errata: Yesterday’s FEHBlog included a post about a Govexec article on Medicare Part B late enrollment penalties. Neil Cain, not Tammy Flanagan, wrote that article.)
  • The American Hospital Association News tells us,
    • “Medicaid enrollment decreased 7.6% in fiscal year 2025 and is expected to be mostly flat in FY 2026, according to KFF’s annual Medicaid Budget Survey released today. Meanwhile, total Medicaid spending increased 8.6% in FY 2025 and is projected to grow 7.9% in FY 2026. States cited provider rate increases, greater enrollee health care needs, and growing costs for long-term care, pharmacy benefits and behavioral health services as key drivers of increased costs. Nearly two-thirds of states said they have at least a “50-50” chance of a Medicaid budget shortfall in FY 2026 as they expect tighter fiscal conditions. The report said that states are facing uncertainty in their long-term fiscal outlook due to slowing revenues, rising costs, and changes in economic conditions and federal policy.” 
  • Adam Fein, writing in his Drug Channels blog, informs us,
    • “As I’ve been warning for years, the Inflation Reduction Act of 2022 (IRA) has nearly obliterated the stand-alone Medicare Part D prescription drug plan (PDP) market.
    • “DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals:
      • The number of PDPs has plummeted by 55% since the IRA’s passage, to a record low of 360 plans for 2026.
      • Preferred cost-sharing pharmacy networks are disappearing, with their share falling to the lowest level since 2014. That’s a post-IRA net loss of 505 plans with these networks. 
      • Just five companies—Aetna, Health Care Service Corporation, Humana, UnitedHealthcare, Wellcare—will account for 94% of all PDPs in 2026. In recent years, four major plan sponsors—Cigna, Clear Spring Health, Elevance Health, and Mutual of Omaha—have exited the PDP market.
  • STAT News reports,
    • “Vice President JD Vance lauded the Make America Healthy Again movement as an “incredible part” of the Trump administration’s success at a mostly closed-door event at the glitzy Waldorf Astoria on Wednesday.” * * *
    • “The vice president adopted Kennedy’s signature skepticism of traditionally accepted public health interventions. His appearance, attendees said, was interpreted as a clear signal of the importance of the MAHA movement to the future of the Republican coalition — and the importance of the Trump administration to accomplishing MAHA’s goals.
    • “I don’t like taking medications,” Vance said, mentioning an aversion to ibuprofen. 
    • “I don’t like taking anything unless I absolutely have to. And I think that is another MAHA-style attitude. It’s not anti-medication, it’s anti-useless-medication,” he continued.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Kyowa Kirin’s big bet on Kura Oncology has paid off in short order, delivering an FDA approval for a medicine to treat a subset of patients with acute myeloid leukemia.
    • “On Thursday, the FDA signed off on Kura’s menin inhibitor ziftomenib as a new treatment for adults with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible nucleophosmin 1 (NPM1) mutation. To qualify for the treatment, which will be marketed under the brand name Komzifti, patients must not be a good fit for any alternative treatments, the FDA said in a Nov. 13 approval announcement.
    • “While specific treatment options for the roughly one-third of AML patients with NPM1 mutations have historically been limited, Syndax Pharmaceuticals broke new ground in late October when the FDA cleared its drug Revuforj as the first menin inhibitor in the indication. Syndax’s drug was originally approved last November to treat a genetic type of leukemia called lysine methyltransferase 2A (KMT2A).
    • “The two meds, both members of the same class, will now likely compete directly over the indication.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership reports,
    • “An influenza strain that emerged over the summer is causing unusually early and severe outbreaks in Canada, the U.K. and Japan, prompting warnings from public health experts about what could be in store for the U.S. as flu season kicks into gear, NBC News reported Nov. 12.
    • “The strain is a version of H3N2, a type of influenza A virus. Influenza A strains are generally known to cause more severe illness, particularly in older adults and young children. Over the summer, it acquired several new mutations, meaning “the virus is quite different to the H3N2 strain included in this year’s vaccine,” Antonia Ho, PhD, an infectious diseases consultant and senior lecturer at the University of Glasgow in Scotland, said in a statement. 
    • “The strain is behind early waves in several countries, experts told NBC. In the U.K., flu cases are already triple what they were around the same time last year and are driving up hospitalizations. Meanwhile, Japan is experiencing an “unprecedented” early flu season, with infections nearly six times what they were at this time last year.” * * *
    • “Vaccine strains are typically selected in February; this year’s shots protect against two types of influenza A and one type of B. Even though the shot is not an exact match for the evolving H3N2 strain, experts say vaccination remains key to reducing the severity of illness and easing strain on hospitals as virus season gathers steam.”
  • Per a November 4, 2025, American Lung Cancer news release,
    • “Today, the American Lung Association released its 2025 “State of Lung Cancer” report, which reveals great strides in efforts to end lung cancer—the leading cause of cancer-related deaths in the U.S. This year, nearly 227,000 people in the U.S. will be diagnosed with lung cancer. The good news is that physicians are detecting lung cancer earlier when it is more likely to be curable, and people are living longer after diagnosis. 
    • “The Lung Association’s eighth annual “State of Lung Cancer” report highlights how the toll of lung cancer varies by state and examines key indicators throughout the U.S., including new cases, survival, early diagnosis, surgical treatment, lack of treatment, screening rates and coverage of comprehensive biomarker testing.” 
  • Fierce Healthcare informs us,
    • “The Leapfrog Group’s latest batch of Hospital Safety Grades is out, and with it a new focus on high performances among system-affiliated hospitals.
    • “The watchdog group’s twice-annual grading, now in its twenty-fifth year, assigned an “A” through “F” letter grade to more than 2,800 acute care hospitals based on patient safety data submitted to the federal government or voluntarily sent to the group through its regular surveys.
    • “The grade includes up to 22 patient safety measures, including a 10-part Medicare composite of reported patient safety and adverse events. Data collected for the grading reached as far back as July 2021 for certain safety measures, including for those collected through Medicare.
    • “This time around, Leapfrog awarded an “A” rating to 899 hospitals (32%), a “B” to 734 (26%), a “C” to 934 (33%), a “D” to 224 (8%) and an “F” to 23 (1%). Compared to the spring’s release, that represents a slight uptick in “C,” “D” and “F” grades.”
  • The Wall Street Journal relates,
    • “Everyone knows walking is good for you, and many of us count our daily steps. But is it better to take a longer walk than a comparable number of steps spread across the day? 
    • “A multinational team of researchers set out to find the answer. Between 2006 and 2010, they recruited adult volunteers from a large-scale health database in Britain, limiting the project to those who averaged less than 8,000 daily steps. It was an older group, ages 40 to 79, with an average of 62, and fairly sedentary, taking a median of 5,165 steps a day. The researchers eliminated those with cancer or cardiovascular disease (CVD). 
    • “The 33,560 who made the final cut wore an accelerometer for about seven days to establish how much they typically walk. Participants were sorted into four categories according to whether they accumulated most of their steps in walks of 5 minutes or less; 5 to 10 minutes; 10 to 15 minutes; or longer than 15 minutes. Scientists tracked them during the 9.5-year study period and published their results in October at annals.org, the website of the Annals of Internal Medicine. 
    • “The main finding: A longer daily walk seems to beat a lot of incidental steps—but there is no need to trek for hours on end. Participants who walked mainly in bouts of at least 15 minutes had an 83% lower risk of dying than those whose walks occurred in bursts of less than 5 minutes. The risk of cardiovascular disease, such as heart attack or stroke, was 68% lower for the longer-session walkers compared with the shortest-burst walkers. 
    • “The study found health benefits even for sedentary people who lengthened their walking sessions but didn’t dramatically increase their steps.”
  • The Washington Post lets us know,
    • Regularly listening to music is linked to a lower risk of developing dementia, according to a new study.
    • In the study, published in October, researchers looked at data spanning a decade and involving more than 10,000 relatively healthy people, aged 70 and older, in Australia. People who listened to music most days slashed their risk of developing dementia by 39 percent compared with those who did not regularly listen to music, the study found.
    • The ASPREE Longitudinal Study of Older Persons followed participants to investigate what factors are associated with the risks of developing various diseases — and how much lifestyle changes could make a difference.
  • Per Fierce Pharma,
    • “Gilead Sciences has developed an industry-leading HIV portfolio in recent years with its megablockbuster daily treatment Biktarvy and its new long-acting pre-exposure prophylaxis (PrEP) medicine Yeztugo. Now, the company is finding success in combining two of the active ingredients in those products.
    • “Gilead’s investigational single-tablet HIV regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) has prevailed in a phase 3 trial, the company announced Thursday.” * * *
    • “People who are on complex regimens for HIV haven’t been able to benefit from single-tablet regimens due to a range of reasons such as resistance to drugs, tolerability and drug-drug interactions, Gilead noted. The promise of the BIC/LEN program is that it could offer a new option for people who remain on complex multi-tablet regimens.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Healthcare cost increases are projected to rise 9.6% in the U.S. in 2026, only a hair less than the 9.7% experienced this year, according to WTW’s 2026 Global Medical Trends report, released Tuesday. However, the increase remains “significantly higher” than the 7.6% seen in 2024. 
    • “Globally, the average cost of health benefits is predicted to rise 10.3%, up from 10% in 2025 and 9.5% in 2024, WTW found. 
    • “Despite variations in healthcare provision in different countries and regions around the world, rising medical costs are a consistent trend for all,” Linda Pham, global health and risk leader for integrated and global solutions for WTW, said in a news release. “One glimmer of hope for employers is that investment in technologies, including AI, is leading to higher costs at the moment but following this phase new technologies hold the promise of reducing healthcare cost trends in the longer term.”
  • Modern Healthcare informs us,
    • “Increased patient volumes and productivity improvements helped drive third-quarter gains for Providence. 
    • “The Renton, Washington-based health system Thursday reported net income of $152 million for the three months ended Sept. 30, compared with net income of $20 million in the same period last year.
    • “Much of the increase came from operations: Providence posted an operating gain of $21 million for the third quarter compared with a $208 million loss in the year-ago period. Operating revenue for the quarter increased 5% to $7.97billion, from $7.58 billion the year before.”
  • and
    • “Labcorp has entered a strategic agreement to acquire select assets of Parkview Health’s outreach laboratory services. 
    • “Financial terms were not disclosed. The deal is expected to close next year, pending closing conditions and regulatory approval, according to a Thursday news release. 
    • “The deal only includes non-emergency outreach laboratory services, the release said. Labs within Parkview’s 15 hospitals would keep providing services to emergency and acute-care patients.”
  • Per Fierce BioTech,
    • “Signed, sealed and delivered, Metsera is finally Pfizer’s. Pfizer has completed its acquisition of the obesity biotech, capping a whirlwind two weeks in which rival pharma Novo Nordisk attempted to swoop in and snatch the startup from under Pfizer’s nose.
    • “As previously announced, Pfizer agreed to pay $65.60 per share upfront for Metsera, while also committing to pay up to $20.65 per share via a contingent value right (CVR). 
    • “The CVR is “tied to the achievement of three specified clinical and regulatory milestones,” Pfizer said in a Nov. 13 release, without providing specifics on the exact goals.
    • “The total deal value of around $10 billion represents a significant uptick from the $7.3 billion value of the companies’ original buyout deal, inked in September.”
  • Bloomberg informs us,
    • “Pfizer Inc. is looking to sell its remaining stake in Covid-19 vaccine partner BioNTech SE, a remnant from one of the pandemic’s most lucrative collaborations. 
    • “The US drugmaker is offering about 4.55 million American depositary receipts via an overnight block trade marketed between $108 to $111.70 per share, according to people familiar with the matter. At the high end of the price range, the stake sale would be worth about $508 million for Pfizer.”
  • Per BioPharma Dive,
    • “Day One Biopharmaceuticals is buying struggling cancer drug developer Mersana Therapeutics, offering $129 million up front to gain control of an experimental cancer drug in early-stage testing, the companies said Thursday.
    • “Per deal terms, Mersana stockholders will receive $25 a share, representing an equity value of $129 million and a roughly 180% premium to the company’s closing stock price on Wednesday. But the bulk of the payouts — an additional $30.25 per share — would only materialize if Mersana’s drug hits a variety of future milestones. The deal’s value would reach $285 million if it does.
    • “Mersana, a developer of a type of targeted cancer treatment called an antibody-drug conjugate, has tested and discontinued several experimental prospects because of safety issues or poor efficacy. Earlier this year, it slashed its workforce and trimmed research to fund operations through late 2026.”
  • Per Beckers Hospital Review,
    • “Amazon Pharmacy will partner with Experity, a healthcare technology platform, to enable patients to order prescriptions during their visit and receive same-day delivery in select markets.
    • “The collaboration will allow patients at urgent care centers to access automatic manufacturer discounts and order medications for direct-to-door delivery through Amazon’s platform, according to a Nov. 13 news release. Amazon Prime members will be eligible for free two-day delivery, and nearly half of U.S. customers are expected to have same-day access by the end of 2025.
    • “A Journal of Urgent Care Medicine study cited in the news release found that patients who received prescriptions onsite at the place of healthcare service had a 2% prescription abandonment rate, compared with 23% for prescriptions that were filled at community pharmacies. Pharmacy-related inquiries also account for 15% of urgent care call volume, the release said.”

Friday Report

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

Happy Halloween!!

From Washington, DC

  • The Wall Street Journal reports,
    • “President Trump’s demand that Republican senators bypass Democrats to reopen the federal government risked upsetting delicate negotiations on Capitol Hill, where lawmakers were finally making progress toward a deal to end the monthlong impasse and head off more pain for American households. 
    • “Optimism had been growing among Republican and Democratic senators involved in talks over recent days, with hopes that a resolution could be reached in the week ahead, people familiar with discussions said. 
    • “But Trump’s new demand in a social-media message late Thursday to eliminate the Senate filibuster rule could complicate the path forward. Meanwhile, food aid is at risk of lapsing for millions of people, the nation’s airports are increasingly snarled, and Affordable Care Act health-plan enrollees are confronted with sharply higher premiums.”
  • Time will tell.
    • “In remarks Friday on his way to Florida, Trump didn’t mention his filibuster demand but reiterated that he was willing to talk with Democrats if they would provide votes to reopen the government. 
    • “Let them open up the country, and we’ll meet,” he said. “It’s so easily solved.” 
    • “A White House spokeswoman said that if Democrats don’t work with Republicans to reopen the government, then the “nuclear option” of ending the filibuster will need to be used.
    • “Senate Republicans are set to return to Washington on Monday night to face a loyalty test on whether they will side with Trump on killing the filibuster or try to seal the deal with bipartisan talks. 
    • “Senate Majority Leader John Thune (R., S.D.) has pledged to protect the longstanding rule. A spokesman said Friday that his position hadn’t changed.”
  • Tammy Flanagan, writing in Govexec, tells us “what federal employees need to know about Medicare enrollment.” She provides “an updated guide to timing, parts, costs and coordination so you don’t get stuck with penalties or surprises at 65.”
  • OPM announced on October 30, 2025,
    • “two new online tools designed to make retirement services faster, and easier for federal retirees. These improvements are part of OPM’s broader effort to modernize its Retirement Services operations and enhance the customer experience through expanded self-service options. Beginning today, retirees can:
      • “Securely download their 1099-R tax forms without logging into Retirement Services Online, offering a faster, paperless option for accessing tax documents.
      • “View current retirement processing times to better understand the expected timeline for the completion of their retirement benefit applications.
    • “These new self-service tools are another step toward delivering the efficient, transparent, and customer-focused experience federal retirees deserve,” OPM Director Scott Kupor said. “By expanding digital access and improving automation, we’re giving retirees more control over their information and freeing up our team to focus on complex cases that require extra care.”
  • Healthcare Dive informs us,
    • “Federal regulators have greenlit eight drugmaker proposals to enact rebates in 340B, upending how savings in the massive drug discount program are normally divvied out to providers.
    • “The approvals were disclosed by the Health Resources and Services Administration, the HHS agency that oversees 340B, on Thursday. They include frequently prescribed drugs manufactured by companies like Bristol Myers Squibb and Johnson & Johnson, two drugmakers that sued the government after it blocked them from implementing their own 340B rebate plans.
    • “Hospital groups slammed the model approvals as benefiting drugmakers at their expense, with America’s Essential Hospitals calling it a “clear case of the fox guarding the hen house.”
  • Roll Call adds,
    • “Lawmakers impatient with the lack of progress on a key health care issue — the long-debated need for changes to what’s known as the 340B drug pricing program — say they are closing in on legislation aimed at what they say are abuses in the program.” * * *
    • “Lawmakers argue the program incentivizes practices that drive up health care costs. A report released last month by the Congressional Budget Office found the program’s design encourages prescription of higher-cost drugs and promotes increased vertical integration among facilities.
    • “When 340B hospitals acquire or open new outpatient clinics, such as infusion centers or specialty medicine practices, those clinics also become eligible for the program. Critics say the hospitals collect discounts on drugs offered at those clinics and then sell them at full price to insured patients.
    • “Our goal is to make health care more affordable, but 340B is making employer-sponsored insurance, which pays for the health care for 150 million people, less affordable,” Senate HELP Chair Bill Cassidy, R-La., said.” * * *
    • The [rebate] pilot [mentioned above] could increase pressure on Congress to pass 340B legislation after debating it for several years, said Darbin Wofford, deputy director of health care for Third Way’s economic program. But action is doubtful with Congress in the throes of a government shutdown.
    • “It’s unlikely we see movement for any 340B policy in Congress this year, but there are opportunities next year and in the following Congress,” Wofford said.
  • The American Hospital Association News reminds us,
    • “Individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace beginning tomorrow through Jan. 15. The AHA offers resources to help people choose the best coverage for themselves and their families.”  
  • Beckers Payer Issues points out six things to know about this ACA marketplace open enrollment period.

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Seven new illnesses and two additional deaths have been reported multistate Listeria outbreak tied to prepared pasta meals, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said yesterday in updates.
    • “A total of 27 people in 18 states have been infected with the outbreak strain of Listeria monocytogenes, with 25 hospitalizations and 6 deaths. One pregnancy-associated infection resulted in fetal loss. Deaths have been reported in Hawaii, Illinois, Michigan, Oregon, Texas, and Utah.
    • “The illness-onset dates range from August 6, 2024, to October 16, 2025. Patient ages range from 4 to 92 years, with a median age of 74 years. Two thirds of patients are women.”
  • The Washington Post reports,
    • “Most children should not receive prescription fluoride, Food and Drug Administration officials said Friday as they announced measures to restrict sales of the cavity-fighting drug.
    • “The agency said children under 3 and older children not at high risk for tooth decay should avoid ingestible fluoride, which is often sold as tablets or drops. It sent letters to manufacturers warning them not to market the products to such children.
    • “Fluoride tablets are often prescribed to children who live in communities that do not put the tooth-strengthening mineral in its water supply. But Health Secretary Robert F. Kennedy Jr. has led the Trump administration’s efforts to crack down on fluoride, including revisiting the decades-old recommendation from the Centers for Disease Control and Prevention to fluoridate water.“ * * *
    • “The American Dental Association recommends prescription fluoride to children ages six months and older who are considered high risk for tooth decay and have little fluoride in their drinking water. 
    • “Scott Tomar, a spokesman for the ADA on community water fluoridation, said the FDA recommendations were not too different then the association’s guidance.”

From the judicial front,

  • Govexec relates
    • In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.,
    • “A federal judge in Boston ruled Friday that the U.S. Department of Agriculture’s plan to pause a food assistance program for 42 million people was illegal — but gave the Trump administration until Monday to respond to her finding before she decides on a motion to force the benefits be paid despite the ongoing government shutdown.
    • “At nearly the same time Friday, a Rhode Island federal judge in a similar case brought by cities and nonprofit groups ordered USDA to continue payments and granted a request for a temporary restraining order.
    • “In Massachusetts, in a Friday afternoon order, District Court of Massachusetts Judge Indira Talwani said she would continue to take “under advisement” a coalition of Democratic states’ request to force the release of funds from a contingency account holding about $6 billion.
    • “Her ruling came a day before a cutoff of Supplemental Nutrition Assistance Program, or SNAP, benefits to low-income households [due to the government shutdown].”
  • The Wall Street Journal reports,
    • “Drugmaker Pfizer on Friday sued obesity-drug developer Metsera and Novo Nordisk, seeking to block Metsera from terminating its multibillion-dollar merger deal with Pfizer after Novo Nordisk made an unsolicited takeover bid.
    • “In a lawsuit filed in Delaware Chancery Court, Pfizer said Novo Nordisk’s offer can’t be considered superior because it isn’t reasonably likely to be completed on the terms proposed.”

From the public health and medical / Rx research front,

  • Beckers Clinical Leadership lets us know,
    • “Respiratory syncytial virus activity is starting to tick up across the country, marking the start of virus season, according to data tracked by epidemiologists and public health experts. 
    • “Routine CDC tracking on respiratory virus trends is on pause amid the federal government shutdown, now approaching its fifth week. However, data from the PopHIVE project at Yale School of Public Health in New Haven, Conn., shows that ED visits for RSV among children under 4 are on the rise.” 
  • Per Medscape,
    • “Impaired glymphatic function — the brain’s waste clearance system — could help explain how cardiovascular disease (CVD) risk factors may drive dementia. 
    • “In a large UK Biobank study, MRI markers of disrupted cerebrospinal fluid (CSF) and glymphatic flow predicted future dementia and were closely linked to vascular risk factors, including high blood pressure, diabetes, smoking, and arterial stiffness.
    • “Discovered just over a decade ago, the glymphatic system depends on the efficient circulation and drainage of CSF. When this process is impaired, the brain’s ability to clear amyloid, tau, and other toxins diminishes, potentially accelerating the development of dementia.
    • “The study shows, with very convincing data, that these markers predict dementia risk, and also that the markers relate to cardiovascular risk factors,” study author Hugh S. Markus, MD, professor of stroke medicine in the Department of Clinical Neurosciences, University of Cambridge, UK, told Medscape Medical News.
    • “This offers a novel way in which one might be able to target or treat dementia. If one could improve glymphatic flow, one could then reduce the risk of dementia.”
  • The Wall Street Journal reports,
    • “Parkinson’s disease is the fastest-growing neurodegenerative disease in the world. But it’s also one of the most preventable, according to Dr. Ray Dorsey, neurologist at Atria Health and Research Institute in New York and co-author of a new book, “The Parkinson’s Plan: A New Path to Prevention and Treatment.”
    • “A progressive nervous-system disorder, Parkinson’s primarily impacts movement. As dopamine-producing brain cells die, movement becomes affected, resulting in tremors, muscle stiffness, slowed movement and impaired balance.
    • “Some doctors like Dorsey say most cases appear to be caused by environmental factors. A study in the journal Brain last year found that only 13% of Americans carry a genetic risk factor for the disease. 
    • “The vast majority of Americans have no known genetic cause or risk factor for their disease,” says Dorsey. “So the principal cause of disease lies not with us, but outside of us, in our environment, in chemicals in our food, water and air.”
    • “Other doctors say conversations about preventing Parkinson are missing the mark.
    • “We’re very much oversimplifying if we say, ‘If we just get rid of that particular pollutant we are going to prevent Parkinson’s,’ ” says Dr. Brad Racette, chair of neurology and senior vice president at Barrow Neurological Institute in Phoenix. “We will probably have a measurable effect on the number of cases, but I think the key message is it’s not as simple as a single pollutant is causing an individual’s Parkinson’s.”
    • The article “offers some of the ways that doctors like Dorsey recommend to potentially reduce your risk of developing Parkinson’s disease.” For example
      • “Research the area near your home. Try not to move to an area near a golf course or Superfund site. A May JAMA Network Open study found that people who live within one mile of a golf course have a 126% increased risk of developing Parkinson’s.
      • “Superfund sites aren’t well marked, but you want to avoid living too close to one since toxic chemicals leak into the soil and eventually the surrounding air. The Environmental Protection Agency has a database to search for sites and environmental firms can test your air.”
  • Per MedPage Today,
    • “Moderate exercise of about 17 metabolic equivalent task (MET)-hours per week significantly reduced the risk of digestive system cancers (DSCs) and DSC mortality.
    • “Optimal risk reduction occurred at about 50 MET-hours per week.
    • “After factoring in consistency, physical activity equivalent to 16.9 MET-hours/week had the same effect on DSCs as 50 MET-hours/week.”
  • Here is a link to an MET calculator.
  • Per BioPharma Dive,
    • “Tucked into its latest earnings report, Eli Lilly disclosed that it has removed from its research pipeline an experimental drug for pain.
    • “The drug, which Lilly in-licensed several years ago, works by inhibiting a protein called P2X7. This protein helps regulate molecules that trigger inflammation and amplify pain signals. Blocking P2X7, Lilly had hoped, would be an effective way to treat conditions like osteoarthritis, chronic lower back pain and the nerve pain that often accompanies diabetes.
    • “However, data from mid-stage tests “did not meet our high internal bar for success,” according to Lilly spokesperson Ashley Hennessey. While the company is “assessing next steps for the program, including possible additional indications,” for now, the drug is out of its pain pipeline.
    • “It’s at least the second Lilly pain program to get axed this year. A drug named mazisotine, designed to boost a pain-relieving protein known as SSTR4, was shelved this summer.”

From the U.S. healthcare business front,

  • Per Fierce Pharma,
    • “For the third straight quarter, AbbVie has jacked up its revenue forecast for 2025. The Illinois drugmaker has raised its guidance by $400 million, now expecting sales to reach $60.9 billion.
    • “The estimate is $1.9 billion higher than AbbVie’s projection from the start of the year, another indication that the company continues to be surprised by the performance of immunology stalwarts Skyrizi and Rinvoq and that it has rebounded from the 2023 loss of patent protection in the United States for Humira, the first drug ever to generate more than $20 billion in annual sales.
    • “Clearly, the momentum is there,” AbbVie CEO Rob Michael said on a Friday conference call. “We’ve beaten and raised in every quarter in 2025.”
    • “The new forecast reflects expectations that Skyrizi sales will reach $17.3 billion in 2025, which is a $200 million increase from AbbVie’s previous estimate based on the drug’s market share gains in psoriasis and inflammatory bowel disease (IBD), chief financial officer Scott Reents said.”
  • and
    • “For the last several quarters, Gilead Sciences’ earnings calls have been colored by anticipation for the launch of the California drugmaker’s long-acting HIV pre-exposure prophylaxis (PrEP) option. This week, Gilead had a chance to share some early returns on the med’s market debut after its FDA approval five months ago.
    • “Since Yeztugo’s U.S. launch in June, the drug has garnered $54 million in sales, Gilead reported on Thursday, with $39 million generated specifically during the third quarter. The company has already secured 75% U.S. payer access for Yeztugo, some three months ahead of its original targeted timeframe of six months post-launch, with 90% expected by the end of the first half of 2026, Gilead said in its third-quarter earnings presentation (PDF). 
    • “Gilead expects $150 million to come from Yeztugo this year, but Citi analysts call this guidance “conservative,” citing broad update and rapid payer coverage as “hallmarks of a strong launch” that the drug has already demonstrated, the analysts wrote in a note to clients. 
    • “On the flip side, Mizuho analysts note that the Yeztugo’s quarterly haul was a “slight miss.”
  • Radiology Business reports,
    • “Hospital giant Intermountain Health has reached a deal to acquire a nearly 40-year-old private radiology practice in Las Vegas, the two announced Thursday. 
    • “The Salt Lake City-headquartered nonprofit is buying Steinberg Diagnostic Medical Imaging for an undisclosed sum, with the integration taking place sometime after Jan. 1. SDMI opened its first office in 1988 and today commands a team of over 550 employees and affiliates, including approximately 30 radiologists. 
    • “Intermountain is growing in southern Nevada and believes adding SDMI and its 12 outpatient imaging centers will help “enhance patient access to high-quality, cost-effective care.” Acquiring the practice also will allow the hospital system to provide more “coordinated and integrated imaging,” said Eric Liston, chief clinical shared services officer. 
    • “As the number of people with chronic and complex health conditions continues to grow, ease of access to high-quality imaging services is more important than ever,” he said in a statement Oct. 30.”
  • Per Fierce Healthcare,
    • “Elevance Health’s Anthem plans are cracking down on hospitals or outpatient facilities that offer services using out-of-network providers.
    • “Beginning Jan. 1 in 11 states, Anthem will impose an administrative penalty equal to 10% of the allowed amount on a facility’s claims that include out-of-network providers. These facilities will also be at risk of termination from Anthem’s provider network, per a notice from the insurer sent out earlier this month.
    • “Ariel Bayewitz, vice president of health economics at Elevance Health, told Fierce Healthcare in an interview that the policy was designed in response to provider behavior under the No Surprises Act (NSA) independent dispute resolution (IDR) process. He said the insurer has seen a consistent pattern of IDR being used as a “back-door payment channel” for pricey, nonemergent procedures.” FEHBlog note — Smart move.
  • and
    • “Online therapy provider Talkspace reported another strong quarter with 25% revenue growth, driven by its expanding payer business, with net income of $3.3 million, up 73% from the same period in 2024.
    • “The company brought in $59.4 million in revenue in Q3, driven by a 42% year-over-year increase in payer revenue, or insurance-covered sessions, to reach $45 million. Talkspace’s direct-to-consumer business, however, continued to decline, with $4.6 million in revenue, down 23% year-over-year. The company’s direct-to-enterprise revenue was $9.3 million, down 1% year-on-year.
    • “The company reported adjusted EBITDA of $5 million, an improvement from $2.4 million adjusted EBITDA in the third quarter of 2024.
    • “The company completed 432,000 insurance-covered mental health sessions in Q3, up 37% year-over-year, and active payer members increased 29% in Q3 to 129,000, Ian Harris, Talkspace’s chief financial officer, said during the company’s third-quarter earnings call.“
  • Per Healthcare Dive,
    • “Healthcare executives see digital health and virtual care as key technologies to improve patient experience, but determining returns from these investments is unclear, according to a survey published this week by healthcare consultancy Sage Growth Partners.
    • “Nearly 60% of respondents said their health system offered virtual primary care and remote patient monitoring. Additionally, half said they offered telehealth for stroke care. 
    • “But fewer than 30% earned significant ROI from most of their virtual care offerings, according to the survey. Plus, many executives said they would need to invest funds to shift to a new virtual care platform in the next few years.” 

Monday report

David Ermer–CDC, Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Roll Call informs us,
    • “Appropriators could finish drafting a compromise version of a three-bill spending package for fiscal 2026 in “two or three days” once the partial government shutdown is over, House Appropriations Chairman Tom Cole, R-Okla., said last week.
    • “The shutdown has stalled work on full-year appropriations for more than three weeks, but Cole said lawmakers in both chambers are close to finishing compromise drafts of the Agriculture, Legislative Branch and Military Construction-VA bills. Those can’t move forward, however, until the government reopens, he said.”
  • The Wall Street Journal adds,
    • “The nation’s largest federal workers’ union called for Congress to end the shutdown now in its fourth week, putting new pressure on Senate Democrats who have repeatedly blocked a Republican measure to reopen the government.
    • “It’s time to pass a clean continuing resolution and end this shutdown today,” said Everett Kelley, president of the American Federation of Government Employees, or AFGE, which represents more than 800,000 employees, referring to a short-term spending bill.
    • “Kelley called the situation an “avoidable crisis” that is harming families and communities. “Both political parties have made their point, and still there is no clear end in sight,” he said.
    • “The union’s demand—a clean continuing resolution—is the same approach the Republicans have urged Democrats to adopt for the past month, though AFGE didn’t mention either party by name. The union didn’t immediately reply to a request for comment.”
  • The Hill notes,
    • “Speaker Mike Johnson (R-La.) on Monday said House Majority Leader Steve Scalise (R-La.) is working with the chairs of three House committees to compile a Republican health care plan as the government shutdown nears the one-month mark and Democrats demand action on expiring ObamaCare subsidies.” * * *
    • “The heads of those House committees of jurisdiction involved in the health care plans would be Ways and Means Chair Jason Smith (R-Mo.), Energy and Commerce Chair Brett Guthrie (R-Ky.), and Education and Workforce Chair Tim Walberg (R-Mich.).”
  • The Defense Department issued a Federal Register notice describing TRICARE benefit changes for 2026.
  • Per an ERISA Industry Committee news release,
    • “The ERISA Industry Committee (ERIC) and employee benefit industry groups today urged The U.S. Departments of Labor, Health and Human Services, and Treasury (the Tri-Departments) to take immediate action to address severe negative consequences of the Independent Dispute Resolution (IDR) process under the No Surprises Act. Despite the Act’s clear goals of protecting patients from surprise medical bills and fostering fair payment negotiations, employers warn that certain providers have increasingly exploited the IDR process.” * * *
    • “The employers called on the Tri-Departments to take three immediate steps to restore the legitimacy of the IDR system, including:
      • Strengthen enforcement to ensure only eligible claims are submitted to IDR.
      • Increase transparency in arbitration decisions and require clear rationale when awards deviate from the qualified payment amount (QPA).
      • Penalize abuse by providers who repeatedly submit ineligible claims.
    • Read the entire employer letter here
  • Federal News Network tells us,
    • “Current and former federal employees affected by the massive 2015 Office of Personnel Management data breach may be losing their identity protection services in the coming year.
    • “IDX, the company providing these services since 2015, sent out emails earlier this month telling recipients of their identity protection services that they would have to renew on their own dime after receiving services for 10 years paid for by the government.
    • “IDX, which has held the identity protection and credit monitoring contract since 2015, sent at least three emails out over the last few weeks offering customers a discount to renew their subscriptions.”
  • Fierce Pharma notes,
    • “More and more, as momentum builds for the soon-to-be-blockbuster Winrevair, Merck’s $11.5 billion buyout of Acceleron in 2021 is looking like a savvy move.
      The FDA has signed off on a label update for the first-in-class activin signaling inhibitor, which was the key piece of the acquisition. The new approval adds language to the medicine’s label about its ability to reduce patients’ risk of hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death.
    • “Paving the way for the label update were results from the phase 3 Zenith trial, which enrolled 172 PAH patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.
    • “Winrevair, added to maximum background therapy, reduced the risk of these events by 76% versus placebo. Patients in the trial’s treatment cohort received a subcutaneous dose of Winrevair every three weeks, and the median follow-up with patients was 10.6 months.”

From the public health and medical / Rx research front,

  • MedPage Today points out,
    • Hormel Foods is recalling nearly 4.9 million pounds of frozen boneless chicken it sold to restaurants, cafeterias, and other outlets after customers reported finding metal in the products, the U.S. Department of Agriculture (USDA) announced. (AP)
    • And a South Dakota company is recalling more than 2.2 million pounds of Korean barbecue pork jerky sold at Costco and Sam’s Club stores, again because the product may be contaminated with pieces of metal, USDA said. (AP)
  • The Hill relates,
    • “More than two years after the mpox outbreak in the U.S. was declared over, a new crop of cases in California has infectious disease experts on edge. 
    • “The mpox outbreak that spread through men who have sex with men was declared over at the start of 2023, though low-level transmission has persisted since then.” * * * 
    • “A collection of three unrelated mpox cases recently detected in California is raising concerns, as they were caused by a more infectious, more dangerous strain of the virus called clade I mpox.”
    • “Joseph Cherabie, a member of the HIV Medicine Association board of directors and assistant professor of infectious diseases at Washington University St. Louis, said it was “only a matter of time” before clade I mpox was detected in the U.S.” * * *
    • “If we learned anything from the 2022 outbreak, casual contact, and, you know, transmission through things like clothing, shared clothing, or sitting on the same seat in a subway or anything like that — that did not occur,” Cherabie said. “You need very close, intimate contact with these lesions. So that is why the predominant means of transmission previously was through sexual contact.”  
  • Your Local Epidemiologist writes in her Substack blog to which the FEHBlog subscribes,
    • “After an unusually quiet October for respiratory viruses, an RSV wave is starting to take hold. Flu remains remarkably low, and Covid-19 transmission is at one of the lowest points we’ve seen in months.
    • “Although CDC data remain paused because of the federal government shutdown, emergency department records compiled by PopHIVE show RSV activity is starting to climb, especially among children under four. This follows a familiar pattern: the virus first hits the youngest children (particularly those under one year) before spreading to adults, often about a month later.”
  • The American Medical Association tells us what doctors wish their patients knew about ovarian cancer prevention. “What is known about risk factors has not translated into practical ways to prevent most cases of ovarian cancer. Three ob-gyns share what to keep in mind.”
  • The New York Times reports,
    • “Surgeons removed a genetically modified pig kidney from a 67-year-old man last week, nearly nine months after he received the pioneering procedure at Massachusetts General Hospital in Boston, officials said on Monday. The kidney was removed “after a period of decreasing kidney function,” according to a statement from the hospital.
    • “The patient, Tim Andrews, lived with the pig kidney for a record-setting 271 days. He was the fourth person in the United States to receive a genetically modified pig kidney. The first two patients died shortly after their transplants; the third had her kidney removed after 130 days, when her body rejected the organ.
    • “Tim set a new bar in xenotransplantation,” the Mass General Brigham statement said, referring to the process of transplanting organs from one species into another.
    • “Mr. Andrews “will now resume dialysis and remain on the list for a human donor kidney,” the hospital added.
    • “The nation faces an acute shortage of human organs. More than 100,000 people are on waiting lists to receive an organ transplant; roughly 90,000 of them are awaiting kidneys.
    • “The shortage has prompted an effort to genetically modify pigs so that their organs can be safely transplanted into humans.”
  • Per MedPage Today,
    • “Surgery alone offered improved survival and a potential cure for select pancreatic cancer patients.
    • “Clear surgical margins and negative lymph node status were essential to better survival.
    • “The findings came from a registry database, not a randomized clinical trial.”
  • and
    • “Estetrol (E4) — one of four natural estrogens — significantly reduced the weighted weekly score of moderate-to-severe vasomotor symptoms in postmenopausal women, according to an analysis of two phase III trials.
    • “Among more than 1,200 women included in E4COMFORT I and E4COMFORT II, the weekly weighted score (WWS) of vasomotor symptoms (VMS), which combined the number and severity of hot flashes, decreased in all treatment arms, including placebo, reported Ekta Kapoor, MBBS, of the Mayo Clinic in Rochester, Minnesota, at the Menopause Society annual meeting
    • “Both examined doses of once-daily oral E4, 15 mg and 20 mg, resulted in greater and statistically significant reductions compared with placebo, and the 20-mg dose demonstrated the largest and earliest reductions, Kapoor reported.”
  • The Washington Post reports,
    • “A sweeping study found thousands of stillbirths occur without clear warning signs
    • “A study led by researchers at Harvard and Mass General Brigham shows stark socioeconomic divides and thousands of unexplained losses, even in seemingly healthy pregnancies.
    • “The study published Monday shows that nearly 30 percent of stillbirths occur in pregnancies that did not appear linked to any previously identified health or clinical risks. The study also found that stillbirth continues to fall unevenly along racial and socioeconomic lines, with Black families and poorer communities being hit hardest.”
    • “Mark Clapp, an obstetrician and maternal-fetal medicine specialist at Massachusetts General Hospital and one of the study authors, said better screening and monitoring are urgently needed.”
  • Per Health Day,
    • Lousy sleep might be an early warning sign for suicide risk among teenagers, a new study says.
    • Teenagers who didn’t get enough sleep on school nights or suffered from interrupted sleep had a significantly higher risk of suicide, researchers reported Oct. 23 in the journal Sleep Advances.
    • “Adolescents who experience difficulties maintaining and obtaining sufficient sleep are more likely to report a suicide attempt several years later,” said lead researcher Michaela Pawley, a doctoral candidate in psychology at the University of Warwick in the U.K.
    • “Poor sleep is not just a symptom of wider difficulties, but a significant risk factor in its own right,” Pawley said in a news release. “Addressing sleep problems could form a vital part of suicide prevention strategies.”
  • Per STAT News,
    • “Experimental CAR-T therapies from Cabaletta Bio and Bristol Myers Squibb have induced complete remissions in patients living with a severe inflammatory muscle disease, results from dual clinical trials being presented this week show. 
    • “The new data, while still preliminary, add to evidence reported over the past several years that personalized cell therapies — already used to treat blood cancers — may be curative for patients with serious autoimmune disorders.
    • “These are patients who take three-to-five medicines every day, every week, every month, at great cost both healthwise and financially,” said Steven Nichtberger, CEO of Cabaletta. With a one-time CAR-T treatment, “We’re showing we can eliminate all of those drugs, giving them the opportunity to no longer be patients. We are freeing them from their disease.” 
  • BioPharma Dive relates,
    • “Shares of Intellia Therapeutics lost nearly half their value Monday a serious safety event led the company to temporarily pause a pair of Phase 3 trials testing its gene-editing drug against the rare disease transthyretin amyloidosis.
    • “Intellia said it has stopped enrollment and dosing in both late-stage studies of the therapy, codenamed nexiguran ziclumeran or nex-z, while it works on new measures to ensure patient safety. The company plans to consult with regulators and independent experts to “develop a strategy to resume enrollment as soon as appropriate,” CEO John Leonard said in the statement.
    • “The enrollee, a man in his 80s and treated on Sept. 30, on Friday experienced a “grade 4” spike in liver enzymes that were concerning enough to require hospitalization. Prior to the stoppage, Intellia had already enrolled more than 650 people with the cardiomyopathy form of transthyretin amyloidosis in one trial and 47 with the polyneuropathy form in its other study.”
  • and
    • “An experimental medicine from BridgeBio Pharma succeeded in a late-stage study in a form of limb-girdle muscular dystrophy, positioning the company to engage U.S. regulators about a potential approval filing. 
    • “Study volunteers with that “type 2I/R9” form of limb-girdle and treated with the drug, BBP-418, had a roughly 17% improvement after three months in “αDG glycosylation,” an important marker of muscle stability and the trial’s main objective. That increase was sustained after 12 months, compared to no change on this measure among placebo-treated participants. No new or “unexpected” safety findings were observed, the company said Monday. 
    • “BridgeBio also said drug recipients had “statistically significant” and “clinically meaningful” improvements after a year in all key trial endpoints studied, including measures of walking ability and lung function. The company will discuss the results with the FDA later this year and intends to submit an approval application in the first half of 2026.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cigna’s Evernorth division is rolling out a rebate-free model for its pharmacy benefit manager, Express Scripts—meaning one of the industry’s “Big Three” is moving away from the oft-criticized approach.
    • “Cigna announced Monday morning that what it’s calling a “new era” for its PBM unit is built on three core elements: transparency, a better patient experience and greater support for community pharmacies. The company said that Evernorth will shift to a pass-through model, where discounts are available upfront to members.
    • “Cigna’s insurance arm, Cigna Healthcare, will adopt this model for its fully insured plans in 2027, and the more transparent model will be the standard offering for all of Express Scripts’ customers beginning in 2028.
    • “Pharmacy benefit managers have successfully driven down costs for Americans with generics and now with biosimilars,” said Adam Kautzner, president of Evernorth Care Management and Express Scripts, in the release. “In this new era of pharmacy benefits, we’re creating more choice for Americans by lowering the costs of expensive brand-name drugs while driving accelerated adoption of generics and biosimilars.”
    • “Our innovative model is a win-win for Americans and their employers—lower costs for Americans, real-time transparency for employers and renewed trust in pharmacy benefits for all,” Kautzner said.
    • Per the announcements, Evernorth estimates that the new model will save members an average of 30% each month on brand-name medications. It will lean on technology to compare pricing options for the patient and ensure they see the lowest cost when they pick up a prescription.
  • Brilliant.
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Massachusetts is expanding its claims review process to address what it is describing as potential overcoding among physicians who routinely bill for high-complexity visits.
    • “The new policy takes effect for dates of service on or after Nov. 3 and applies to a small subset of clinicians whose billing patterns stand out from peers, BCBSMA told Becker’s.
    • “Under the program, BCBSMA will review evaluation and management claims from providers who consistently bill visits at the highest complexity levels (4 and 5) to ensure that the services billed match the severity of the conditions reported. Reimbursement may be reduced if the insurer decides that overcoding has occurred.
    • “BCBSMA estimates that 1% to 2% of primary care physicians and 3% to 4% of specialists in its network will be subject to the expanded process. Clinicians can submit additional documentation and appeal to have claims reinstated as originally billed.”
  • Per Medical Economics,
    • “Sites of care, price transparency, competition and consolidation all play a role in U.S. health care in 2025, and likely will in coming years.
    • “There also could be changes in store — and there should be, if the nation wants to improve the value of a vital service now accounting for almost 20% of America’s gross domestic produce, according to health care economic analyst Trilliant Health.
    • “The new report, “2025 Trends Shaping the Health Economy,” posits that the health care system is at a crossroads with a choice to make: find ways to improve outcomes and value from within, or face new external regulation that might not be what the sector wants.”
  • and
    • “A new KFF/Washington Post survey offers a detailed look at how American parents view their children’s health — and who they trust most for medical guidance. Conducted in summer 2025, the survey shows a nation largely united in concern over issues like mental health and diet, but deeply divided on vaccines, public health institutions and the balance between personal freedom and medical authority.
    • “For physicians, the results underscore a growing need to rebuild and reinforce trust at the point of care, as families increasingly navigate conflicting messages from social media, politics and federal agencies.
    • “Find an in-depth analysis of the survey’s findings here.”
  • Per Fierce Healthcare,
    • “Community Health Systems (CHS) announced Friday evening a new definitive agreement to sell three Pennsylvania hospitals to affiliates of Tenor Health Foundation, a recently formed nonprofit. 
    • “Early discussions on the deal and a signed letter of intent had been reported during the summer and confirmed at the time by company representatives. The deal is a second attempt for CHS to sell off its Commonwealth Health system after a prior purchase agreement with WoodBridge Healthcare was called off last year. 
    • “Involved in the transaction are the 186-bed Regional Hospital of Scranton, the 122-bed Moses Taylor Hospital and the 369-bed Wilkes-Barre General Hospital, as well as their affiliate sites.
    • “Financial terms of the deal are not being disclosed. CHS said in its announcement that a close is contingent on Tenor finalizing its funding, as well as on customary regulatory approvals.”   
  • Per Beckers Hospital Review,
    • “Nearly 75% of active drug shortages in the U.S. began in 2022 or earlier, with some persisting for more than five years.
    • “According to a report from the American Society of Health-System Pharmacists released in September, the number of active shortages declined to 214 in the third quarter of 2025 — the lowest since early 2018 and a steep drop from the record 323 reported in the first quarter of 2024. While the trend is improving, the ASHP warned that persistent shortages of commonly used medications, including lorazepam and triamcinolone injections, continue to disrupt care.
    • “Long-term shortages now account for most active disruptions, with the ASHP noting that nearly 75% began in 2022 or earlier. These prolonged gaps in supply often require health systems to modify treatment plans, locate alternatives and update clinical workflows.”

Friday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, No Surprises Act, Obesity, U.S. Healthcare, Uncategorized–

From Washington DC

  • The Wall Street Journal reports,
    • “Lawmakers are exploring options to end the government shutdown or mitigate its impact on federal workers and lower-income households.
    • “Some Republicans are considering stand-alone measures to pay specific groups of workers or fund certain programs during the shutdown.
    • “Democrats are facing increased pressure from constituents to end the shutdown, despite their stance on healthcare spending and federal workers.”
  • and
    • “The Pentagon said it received a $130 million donation from an anonymous private donor to cover military salaries during the government shutdown.
    • “The donation was accepted under the Defense Department’s “general gift acceptance authority” and is designated for servicemembers’ pay and benefits.
    • “President Trump announced the donation, calling the unnamed benefactor a “patriot,” as military members faced missing paychecks.”
  • Healthcare Dive tells us,
    • “Senators on both sides of the aisle expressed support for reforming the 340B drug discount program during a Thursday hearing of the Health, Education, Labor, and Pensions Committee — though lawmakers also cautioned that a careful approach is needed to ensure changes don’t harm rural hospitals and health centers.
    • “The hearing centered around concerns that 340B, although well-intentioned, has grown too large and may not ultimately benefit patients.” * * *
    • “Efforts are being led by a bipartisan working group formed in March, comprised of Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.V.; Tim Kaine, D-Va.; Markwayne Mullin, R-Okla.; and John Hickenlooper, D-Colo.” 
  • Per a Social Security news release,
    • “Social Security benefits and Supplemental Security Income (SSI) payments for 75 million Americans will increase 2.8 percent in 2026. On average, Social Security retirement benefits will increase by about $56 per month starting in January.
    • “Over the last decade the cost-of-living adjustment (COLA) increase has averaged about 3.1 percent.  The COLA was 2.5 percent in 2025.”
  • CMS announced today that “The Federal IDR Team released updates to the Federal IDR Portal’s Notice of IDR Initiation web form to improve the duplicate dispute validation process.” Duplicate arbitration requests were one on the principal concerns raised by the AHIP/BCBSA NSA survey noted in yesterday’s FEHBlog post.
  • Federal News Network adds,
    • “Starting in January 2026, many federal retirees will see a 2.8% cost-of-living adjustment (COLA) increase in their Social Security benefits and federal retirement annuities.
    • “That’s a higher rate than last year, and higher than projections set by AARP and the Senior Citizens League. About 75 million people, including retirees and individuals with disabilities, receive Social Security benefits.
    • “The annual COLA is meant to keep federal retirees’ and Social Security recipients’ benefits on pace with rising inflation. But not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, based on the following formula:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • “According to those parameters, FERS retirees will receive a “diet” 2026 COLA of 2% for their retirement benefits, starting in January.”
  • FedWeek gives federal and postal employees and annuitants advice on how to approach the upcoming open season.

From the Food and Drug Administration front,

  • Fierce Pharma informs us,
    • “Following a slight delay earlier this year—and a world-first green light in the U.K. over the summer—Bayer has clinched an FDA nod to bolster the limited arsenal of nonhormonal treatments for some of the most common symptoms of menopause.
    • “Friday, the FDA approved Bayer’s dual neurokinin (NK) targeted therapy elinzanetant, which will now be marketed in the U.S. under the brand name Lynkuet, to treat moderate to severe vasomotor symptoms—comprising hot flashes and night sweats—in people with menopause.
    • “Lynkuet comes in a soft gel capsule and is taken once a day at bedtime, Bayer noted in an Oct. 24 press release. The drug is designed to target both the NK1 and NK3 receptors in the brain, which play a role in temperature regulation, the German drugmaker explained.”
    • “Bayer plans to launch Lynkuet in the U.S. starting next month.”
  • and
    • “Azurity Pharmaceuticals has scored an FDA approval for its blood pressure medicine Javadin. The oral solution was developed for patients who have difficulty swallowing tablets or capsules.
    • “Javadin becomes the first immediate-release, ready-to-use oral clonidine formulation for the treatment of hypertension. The berry-flavored treatment can eliminate the need for tablet cutting, compounding or the use of transdermal delivery products to lower blood pressure.
    • “According to the Massachusetts-based company, a recent study showed that more than a third of primary care patients have difficulty swallowing oral medications, with many resorting to splitting or crushing their tablets or opening their capsules to ingest them.”

From the public health and medical / Rx research front,

  • The American Hospital Association News informs us,
    • “Getting an annual flu vaccination is the best way to prevent flu and its potentially serious complications. 
    • “The Centers for Disease Control and Prevention recommends that anyone 6 months of age and older get vaccinated, particularly people who are at a high risk for flu complications. This includes people 65 years and older, young children, and people with chronic conditions such as asthma or heart disease. Individuals who care for or live with these high-risk populations also should get vaccinated.
    • “The 2024-2025 flu season was intense, with high levels of activity and hospitalizations across the country. Somewhere between 47-82 million people fell ill, causing an estimated 27,000-30,000 deaths. The flu vaccine is updated for the 2025-2026 season and is now available at many workplaces, hospitals, clinics, pharmacies and other locations.
    • “Making the case for the value of flu vaccination is easy, but individuals and communities must be proactive in committing to receive them. For 10 years, the AHA has been pleased to lead United Against the Flu, a collaborative effort by several national health care organizations to amplify the importance of getting the annual vaccine.”
  • BioPharma Dive adds,
    • “Sanofi on Friday reported a sharp decline in quarterly vaccine sales, a development the French company partially tied to lower immunization rates in the U.S.
    • “In its latest earnings report, Sanofi said that its overall vaccine sales fell by 7.8% to €3.4 billion, or $3.9 billion, between July and September. The pullback was largely driven by a slowdown in influenza shots, which, combined with the revenue Sanofi derives from Novavax’s COVID-19 vaccine Nuvaxovid, decreased by 16.8%, to €1.5 billion. Sanofi’s COVID-19 and influenza vaccine sales are down a total of 14% this year, the company said.” * * *
    • “It’s early. We’re still in October. But I think it’s fair that with the first few weeks that we observed a little bit of vaccination rate on the soft side when it comes to flu vaccination, particularly in the U.S.,” Thomas Triomphe, Sanofi’s head of vaccines R&D, told analysts.”
    • [Absent the shutdown, we would have had CDC info on this topic.] 
  • The University of Minnesota’s CIDRAP relates,
    • “New research suggests that nearly 1 in 5 urinary tract infections (UTIs) in Southern California may be caused by strains of Escherichia coli that originated in food-producing animals.
    • “For the study, a team led by scientists at George Washington University and Kaiser Permanente Southern California (KPSC) conducted molecular analysis of more than 5,700 extraintestinal pathogenic E coli (ExPEC) isolates collected from UTI patients and retail meat samples from stores in the neighborhoods where those patients lived. Using comparative genomic analysis and a model they developed to infer the host origin of each isolate, they found that 18% of the UTIs were linked to ExPEC strains that came from the meat.
    • “They also discovered that UTIs in patients from high-poverty neighborhoods were 60% more likely to be caused by these zoonotic (animal-to-human) ExPEC strains. 
    • “The findings were published yesterday in the journal mBio.
    • “These findings underscore the contribution of zoonotic ExPEC to the UTI burden in Southern California and the need for targeted interventions to reduce risk in vulnerable communities,” the study authors wrote.”
  • Per STAT News,
    • “Telehealth companies that have seized on the boom in weight loss drugs are playing a bigger role not just in treating patients with obesity but also shaping how the medical mainstream understands obesity.
    • “A dominant player in the field, Ro, said Friday it has launched a new questionnaire designed to measure “food noise,” a term that people with obesity often use to describe incessant and debilitating thoughts about food. One of the aims of the scale, which was developed by academic researchers with funding from Ro, is to help assess whether treatments can “quiet” patients’ level of food noise, a concept that has become more popular in recent years with the advent of new GLP-1 drugs Wegovy and Zepbound.
    • “The telehealth firm is already using the scale to track patients’ progress as they go through treatment, and it’s also licensing it out to pharma companies to use in clinical trials.
    • “WeightWatchers, which also provides telehealth care, earlier rolled out its own food noise scale.
    • “Proponents of these scales say that food noise anecdotally appears to be a common experience for people with obesity, so it’s important to measure it in an objective way to understand a range of questions — for instance, whether certain populations experience it more, how much of it is tied to a person’s weight, and ultimately, which interventions can help.”
  • Per Healio,
    • “Decreasing alcohol intake, even if an individual reports having two or fewer drinks per day, may have a positive impact on blood pressure, researchers reported.
    • “New data published in the Journal of the American College of Cardiology showed how small reductions in alcohol intake can lower BP for both men and women. 
    • “The implications are quite direct. For individuals with hypertension — as well as for the general adult population — stopping alcohol intake can be viewed as a practical, non-pharmacological strategy associated with lower BP,” Takahiro Suzuki, MD, MPH, clinical fellow at St. Luke’s International Hospital and PhD student at the Institute of Science Tokyo, told Healio. “Importantly, this recommendation should not be limited to heavy drinkers. Our findings demonstrate that even light to moderate drinkers can gain measurable benefit from stopping alcohol. A reduction of just 2 mm Hg in systolic BP can meaningfully decrease the risk of stroke and CV death at the population level. Thus, encouraging minimal alcohol intake for everyone could have significant population-level health benefits. … These results align with and support the 2025 American College of Cardiology/American Heart Association guidelines that include recommendations for alcohol abstinence or limiting intake.”
  • Per MedPage Today,
    • “A risk model showed promise for risk-stratifying women for breast cancer treatment-related heart failure or cardiomyopathy.
    • “The model achieved an overall accuracy of about 80% over 10 years.
    • “Older age, specific systemic therapies, and pre-existing cardiac risk factors contributed the most to the model.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare reported a net income of $1.6 billion (8.6% margin) in the third quarter, a significant improvement on the $1.3 billion net income (7.3% margin) posted in the third quarter of 2024. HCA said the strong financial results were driven by higher revenue, improved earnings and growth in same-facility admissions.
    • “For the nine months ending Sept. 30, 2025, HCA reported a net income of $4.9 billion (8.7% margin) compared to $4.3 billion (8.3% margin) in the prior-year period. 
    • “Our teams continued to execute our agenda at a high level, and we remain disciplined in our efforts to improve care for our patients by increasing access, investing in advanced technology, and training our people,” CEO Sam Hazen said in an Oct. 24 earnings release. “Across many operational measures, including quality and key stakeholders’ satisfaction, outcomes were better.”
  • and
    • “More hospitals have closed in Pennsylvania than in any other state this year, reflecting a growing crisis in the state’s healthcare infrastructure. 
    • “Of the 22 hospital closures Becker’s has reported on in 2025, four were in Pennsylvania. One additional hospital — Sharon (Pa.) Regional Medical Center — closed in 2024 but was acquired and reopened in May by Tenor Health Foundation, a newly formed nonprofit.
    • “Pennsylvania’s hospital challenges are multifaceted, involving a combination of overextended acquisition strategies, reimbursement shortfalls, workforce shortages and a rising tide of high-severity malpractice settlements.
    • “According to Radha Savitala, co-founder and CEO of Tenor Health Foundation, part of the issue stems from Pennsylvania’s high number of hospitals — many of them rural — and the fact that some health systems likely overpaid for certain acquisitions in the state more than a decade ago.”
  • MedCity News interviews interviews Puneet Maheshwari, UHC senior vice president and general manager of Optum Real, about the new AI driven claims processing system.
  • Beckers Payer Issues adds,
    • “Elevance Health is deepening its use of artificial intelligence enterprise-wide, focusing on enhancements to its member services, clinical workflows and provider operations as part of long-term efforts to simplify care delivery and reduce costs.
    • “Chief Digital Information Officer Ratnakar Lavu told Becker’s the company’s goal is “to keep the patient at the center and a focus on the experience, not technology for the sake of technology.”
    • “Elevance’s strategy is among a broader industry shift among large insurers using AI not just for automation, but for personalization and decision support that spans both administrative and clinical processes.”
  • BioPharma Dive relates,
    • “Adverum Biotechnologies, a gene therapy developer, has agreed to sell all its outstanding shares to Eli Lilly for an upfront amount that is less than the company’s most recent closing stock price.
    • “Lilly, through an acquisition announced Friday, plans to pay $3.56 in cash for each share — reflecting a nearly 15% discount from the $4.18 price they traded at the day prior. Yet, Adverum investors would also receive so-called contingent value rights that may be worth up to $8.91 per share if the company’s most advanced therapy hits certain goals.
    • “Altogether, the deal value could reach roughly $261 million.
    • “Adverum, formerly named Avalanche Biotechnologies, has been working for nearly two decades to develop genetic medicines for sight-threatening eye diseases. The company raised $102 million in 2014 by going public, and changed its name not long after as part of a reverse merger. Its lead research program is evaluating whether a gene therapy known as “ixo-vec” can help patients with the “wet” form of a degenerative eye condition that affects millions of people in the U.S. alone.”

Friday report

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Columbus Day Holiday Report

David Ermer–Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

Supplementing yesterday’s Weekend Update

From Washington, DC,

  • The AP reports,
    • “President Donald Trump said Saturday that he has directed the Defense Department to use “all available funds” to ensure U.S. troops are paid Wednesday despite the government shutdown, a short-term fix that will not apply to the hundreds of thousands of federal workers who have been furloughed.
    • “Trump said in a social media post that he was acting because “our Brave Troops will miss the paychecks they are rightfully due on October 15th.”
    • ‘The Republican president’s directive removes one of the pressure points that could have forced Congress into action, likely ensuring that the shutdown — now in its 11th day and counting — extends into a third week and possibly beyond. But no similar action seems forthcoming for federal employees also working without pay while thousands are now being laid off during the lapse in government operations.”
  • Federal News Network tells us,
    • “The number of federal employees filing retirement claims in September was the lowest all year. Just over 6,300 employees submitted their retirement paperwork to the Office of Personnel Management. At the same time, OPM also processed the fewest number of current claims in September, just over 7,900. Despite the lower number of claims, OPM said it took six days longer, on average, in September than in August to process claims. The current retirement claims backlog is at 23,500, which dropped for the fourth straight month.”
  • The Washington Post interviews OPM Director Scott Kupor and others about the coming surge of retirement applications.
  • Per Beckers Payer Issues,
    • “The No Surprises Act is succeeding in protecting patients from unexpected medical bills, but insurers and provider groups remain divided on what is driving rising costs tied to the Independent Dispute Resolution process and how regulators should respond.
    • “Since the arbitration system launched in 2022, providers have won the vast majority of disputes. In 2024, they prevailed in about 85% of cases, with median payment determinations reaching 459% of the qualifying payment amount in the fourth quarter. The process has also generated at least $5 billion in costs, much of it from administrative fees and higher payments.
    • “As those costs have climbed, payers have said that the system is inflating prices across the healthcare system, while providers say it is correcting years of underpayment.
    • “The concern now is that the law hasn’t met its second objective, to contain costs,” Jennifer Jones, senior director of legislative and regulatory policy at the Blue Cross Blue Shield Association, told Becker’s. “That’s primarily because of the challenges we’re seeing with the independent dispute resolution process.”
  • The FEHBlog agrees with Ms. Jones.

From the public health and medical / Rx research front,

  • MedPage Today informs us,
    • “Among older adults who received at least one dose of the recombinant shingles vaccine, vaccine effectiveness against any herpes zoster-related outcome was 56.1%.
    • “Getting a second dose yielded a relative vaccine effectiveness of 67.9% against any herpes zoster outcome.
    • “The findings emphasize the importance of completing the full vaccination series.”
  • The Washington Post reports,
    • “The tendency to use cannabis is associated with genes linked to impulsive behavior, obesity, schizophrenia and bipolar disorder, among other traits, according to a study released Monday by researchers at the University of California at San Diego.
    • “The research, published in the journal Molecular Psychiatry, explored the genetic traits of casual and frequent cannabis users in hopes of eventually identifying medications and other therapies to treat or prevent problematic marijuana use.
    • “The study adds to a growing body of genetics research into cannabis use as policymakers and researchers weigh how to balance the benefits and consequences of the drug’s growing popularity.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Many nonprofit hospitals and health systems have made steady progress on financial turnarounds since the end of the COVID-19 pandemic — though others continue to struggle — but new and persistent challenges threaten to derail those efforts.
    • “Operating margins have inched upward across the sector, yet most remain far below the pre-pandemic “magic number” of 3%. The latest data from Strata Decision Technology shows that health system margins improved slightly to 1% in August, up from 0.9% in July, but remain relatively unchanged for the year. 
    • “While operating revenue has generally increased, it continues to be offset by rising costs — particularly in non-labor categories (such as supply and drug costs), which rose 5.7% year over year compared to a 4.6% rise in labor expenses.
    • “These pressures could intensify in the months ahead.” 
  • Beckers Payer Issues adds,
    • “When a critical patient’s prognosis is unclear, often because they are unable to wean from the ventilator, care teams begin to discuss palliative care, advance care planning, and even hospice.  Making decisions about long-term care goals can be challenging for patients and their families as they navigate the complexities of their conditions. Discussions often take place over many days while patients and families evaluate the options.  Including long-term-acute care hospital (LTACH) referral in these discussions benefits the patient for three reasons [explained in the article].

Tuesday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • “Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”