Friday report

Medical / Rx research

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare, Wellness–

From Washington, DC,

  • The Washington Post reports,
    • “House Republicans unveiled a new health care proposal Friday as they aim to address concerns about rising health insurance costs just weeks before enhanced Affordable Care Act subsidies expire.
    • “The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market and increase transparency in prescription drug pricing, according to House Republican leadership aides.
    • “The proposal would also allow for a separate vote on an extension of the premium ACA tax credits, which subsidize health insurance for most of the 24 million Americans who buy their coverage from the Obamacare Marketplace — the central demand Democrats and moderate Republicans have made in the recent health care debate.
    • “The House is expected to vote on the proposal next week before leaving Washington for a two-week holiday break. If passed, it is unclear if the proposal could succeed in the Senate, where it would require 60 votes to overcome a filibuster.”
  • FEHBlog observation — This week, the Democrat leadship in the Senate offered a three year extension extension of the Biden subsidies while the Republican leadership offered a new approach with no transistion period. Both offerings were doomed to fail. The FEHBlog hopes that cooler heads prevail over the next week.
  • Govexec relates,
    • “The House voted 231-195 on Thursday to pass legislation that would nullify President Trump’s efforts to strip more than 1 million federal workers of their collective bargaining rights, sending the measure over to the Senate, where its prospects are less rosy.
    • “Twenty Republican lawmakers broke ranks to support the Protect America’s Workforce Act (H.R. 2550) on the floor. Introduced by Reps. Jared Golden, D-Maine, and Brian Fitzpatrick, R-Pa., the measure effectively nullifies Trump’s March executive order barring unions at more than 40 federal agencies under the guise of national security and bars federal agencies from terminating any union contracts that were in place prior to the edict’s signature.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Dec. 11 announced the launch of the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence Model, a voluntary payment model that will fund up to 30 chronic disease prevention and health promotion proposals. The proposals must include evidence-based functional or lifestyle medicine interventions not covered by Original Medicare. Under the MAHA ELEVATE Model, CMS said it will evaluate necessary data on the cost and quality of such interventions to inform future decisions on the feasibility of including them in Original Medicare. The agency will release a funding notice in early 2026 for the first cohort, which will begin Sept. 1, 2026. The second cohort will begin one year later.”
  • The U.S. Office of Personnel Management announced today that it is seeking public comments on its plan to resurrect its FEHB and now also PSHB health claims data warehouse.
    • “OPM is collecting service use and cost data from FEHB and PSHB Carriers, including medical claims, pharmacy claims, encounter data, and provider data. This data will enable OPM to oversee health benefits programs and ensure they provide competitive, quality, and affordable plans. OPM requires Carriers to report necessary information and permit audits and examinations to manage the FEHB Program effectively. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities, including carriers, to disclose protected health information (PHI), including service use and cost data, to health oversight agencies, such as OPM, for oversight activities authorized under 45 CFR 165.512(d)(1).”
    • This is a legally flawed analysis. The FEHB Act, 5 U.S.C. Sec. 8910(b), states
      • “(b) Each contract entered into under section 8902 of this title shall contain provisions requiring carriers to—
      • “(1) furnish such reasonable reports as the Office determines to be necessary to enable it to carry out its functions under this chapter; and
      • “(2) permit the Office and representatives of the Government Accountability Office to examine records of the carriers as may be necessary to carry out the purposes of this chapter.”
    • Furnishing all claims data to OPM is a not a reasonable report in any sense of the English language, and the HIPAA Privacy Rule does not give health oversight agencies new data access rights. See Fed. Reg. 82,462, 82,528 (Dec. 28, 2000). OPM should head back to the drawing board for consultations with carriers.
    • The public comment deadline is February 10, 2026.
  • On a related note, per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the 2026 CMS Burden Reduction Conference taking place February 25, 2026, from 9:00 a.m. to 1:00 p.m. ET. This year’s conference will be a hybrid event, with in-person programming at the Hubert H. Humphrey (HHH) Building in Washington, DC, and a fully supported virtual option for remote attendees. In-person attendance will be limited due to space.”
  • OPM should hold a similar event for overburdened FEHB and PSHB carriers.

From the Food and Drug Adminstration front,

  • Per Fierce Pharma,
    • “Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new indication for its monoclonal antibody Uplizna.
    • “Thursday, the FDA greenlighted Uplizna (inebilizumab) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year, Amgen noted in a Dec. 11 press release.”
  • and
    • “After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. 
    • “On Friday, the U.S. regulator green lit Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.
    • “The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
    • “The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
    • “With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy,” Steve Rybka, CEO of Vesalio, said in a statement. “Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase in most areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years. It was 56% effective for those ages 5-17 years old. “These findings suggest that vaccination with a 2024–2025 COVID-19 vaccine dose provided children with additional protection against COVID-19–associated ED/UC encounters compared with no 2024–2025 dose,” the CDC wrote.”
  • The New York Times reports,
    • “To treat their pain, anxiety and sleep problems, millions of Americans turn to cannabis, which is now legal in 40 states for medical use. But a new review of 15 years of research concludes that the evidence of its benefits is often weak or inconclusive, and that nearly 30 percent of medical cannabis patients meet criteria for cannabis use disorder.
    • “The evidence does not support the use of cannabis or cannabinoids at this point for most of the indications that folks are using it for,” said Dr. Michael Hsu, an addiction psychiatrist and clinical instructor at the University of California, Los Angeles, and the lead author of the review, which was published last month in the medical journal JAMA. (Cannabis refers to the entire plant; cannabinoids are its many compounds.)”
  • The AP informs us,
    • “The U.S. suicide rate dropped slightly last year from some of the highest levels ever reported, preliminary data suggests. Experts say it’s hard to know exactly why, or whether the decline will continue.
    • “A little over 48,800 suicide deaths were reported in 2024, according to provisional data from the Centers for Disease Control and Prevention, roughly 500 fewer than the year before.
    • “The overall suicide rate fell to 13.7 per 100,000 people.”
  • The Washington Post relates,
    • “Solving a technical challenge that has stymied science for 40 years, researchers have built a robot with an onboard computer, sensors and a motor, the whole assembly less than 1 millimeter in size — smaller than a grain of salt.
    • “The feat, accomplished by a partnership of researchers at the University of Pennsylvania and University of Michigan, advances medicine toward a future that might see tiny robots sent into the human body to rewire damaged nerves, deliver medicines to precise areas, and determine the health of a patient’s cells without surgery.”
  • Per Healio,
    • “GLP-1 receptor agonists are not associated with increased risks for dry age-related macular degeneration or cataract development, according to two recently published studies.
    • “The data instead showed significantly reduced risk for cataracts, as well as lower risk for dry AMD, linked with the use of GLP-1s, according to Abhimanyu Ahuja, MD, an ophthalmology resident at the Oregon Health & Science University Casey Eye Institute, and colleagues.
    • “Other studies have demonstrated that these medications have anti-inflammatory and neuroprotective properties,” Ahuja told Healio. “We wondered whether they might influence the risk of conditions like macular degeneration or cataracts in older adults.”
  • Per MedTech Dive,
    • “AtriCure, whose devices are used to treat atrial fibrillation and related conditions, said Thursday the first procedures were performed in patients with its new dual energy platform.
    • “The system integrates pulsed field ablation with a radiofrequency ablation approach using the company’s cardiac clamp technology. Surgeons can use either method independently or in combination.
    • “The platform is not yet approved for use in any market. AtriCure said it expects to initiate a clinical trial in the coming year.”
  • Per Biopharma Dive,
    • “Arcus Biosciences will terminate work on a TIGIT-targeting cancer drug following a decision to cancel a Phase 3 trial because it didn’t appear likely to improve patients’ survival, the company said in a statement Friday.
    • “Called domvanalimab, the drug was being tested in combination with the immunotherapy zimberelimab and chemotherapy against Bristol Myers Squibb’s Opdivo and chemo in gastric and esophageal cancers that haven’t been treated before. Arcus said an independent data committee recommended ending the trial because the domvanalimab combination wasn’t likely to help patients live longer.
    • “The domvanalimab-based combination was the centerpiece of a partnership with Gilead Sciences that led the bigger company to buy a 33% stake in Arcus and pay $900 million just to secure rights.”

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

  • Healthcare Dive reports,
    • “Hospitals are managing series of cost, workforce and reimbursement challenges as they navigate uncertainty at the close of 2025 and beyond, according to a new report from Kaufman Hall.
    • “Health systems are attempting to mitigate the impact of tariffs and increasingly expensive supplies, according to Kaufman Hall’s 2025 Health System Performance Outlook report. At the same time, hospitals are trying to retain clinical staff and outsource other functions, according to the report.
    • “Only 30% of hospital leaders surveyed expect balance sheets to improve in 2026, while 30% expect them to lower and 40% projected little change. The split highlights how uncertain health systems feel about the future, especially from recent regulatory changes in the “Big Beautiful Bill” and the likely expiration of Affordable Care Act subsidies.”
  • Beckers Hospital Review relates,
    • “Dallas-based Tenet Healthcare reached a record high stock price of $218 on Nov. 25, capping off a transformative year that highlights investor confidence in the system’s ongoing shift toward specialty and outpatient care.
    • “As of Dec. 12, Tenet stock remained elevated at $199, up nearly 60% from $125 on Jan. 2. The spike reflects investor optimism around Tenet’s long-term strategy to transform into a value-based care enterprise anchored by its ambulatory business, United Surgical Partners International.
    • “In 2024, Tenet sold 14 hospitals for a combined $4.8 billion as part of a sweeping overhaul. The system now operates 50 acute-care hospitals while aggressively expanding its ambulatory surgery center footprint through USPI.”
  • Beckers Payer Issues tells us about 14 payer AI moves this year and “Turquoise Health has detailed its first comprehensive payer price transparency scores in its 2025 impact report, evaluating machine-readable file quality across 97 payers.” 

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “A Democratic effort to extend expiring healthcare subsidies drew some Republican votes but failed to advance in the Senate on Thursday, leaving no clear path in Congress for aiding millions of Americans facing soaring costs for their Affordable Care Act coverage next year.
    • “The proposal would have extended the enhanced Covid-era ACA subsidies for three years. The bill was backed by 51 senators—including Republican Sens. Lisa Murkowski and Dan Sullivan of Alaska, Susan Collins of Maine and Josh Hawley of Missouri—with 48 opposed, short of the 60 votes needed to advance under the Senate’s filibuster rule.
    • “Republicans, who control the chamber 53-47, put forward an alternative healthcare bill that wouldn’t extend the subsidies but instead offers federal funds to some households to put toward out-of-pocket healthcare costs. That proposal failed with 51 in favor and 48 opposed. All Republicans except Sen. Rand Paul of Kentucky supported the measure, while no Democrat voted for it.
    • “The lack of progress in Congress has left many of the nation’s ACA enrollees in a precarious situation. With open enrollment closing on Dec. 15 for plans starting Jan. 1, households are signing up now for coverage with sharply higher costs, with no guarantee that Congress will act to restore subsidies and bring the price tag down. Others are expected to skip coverage altogether.
    • “With the failure of the two votes Thursday, hope is fading for any deal to extend the subsidies before the end of the year, if at all. The next major legislative deadline is Jan. 30, when lawmakers need to pass a new bill funding the government. Still, some lawmakers believed a deal could still be reached.
    • “I hope that there are enough people on both sides who want to come to the table and get a compromise,” said Sen. Jeanne Shaheen (D., N.H.).”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “OPM’s retirement application pile remains large as the year draws to a close
    • “New retirees awaiting full benefits may face holiday heartache as the backlog swelled to nearly 50,000 by the end of November.”

From the Food and Drug Administration front.

  • The Washington Post reports,
    • “An in-home headset that allows people with depression to send mild electrical current to their brains has been cleared by the Food and Drug Administration, in what medical experts consider a milestone for expanding mental health treatment beyond drugs.
    • “The prescription device, made by Flow Neuroscience, is designed to counteract moderate to severe depression in adults by delivering electric stimulation to an area of the brain that controls mood and stress. While such stimulation is widely used to treat depression, Flow is aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics. The FDA said testing showed “modest” results for patients.”
  • Per MedTech Dive,
    • “Intuitive Surgical said Wednesday its da Vinci SP surgical robot received Food and Drug Administration clearance for use in inguinal hernia repair, gallbladder removal and appendectomy procedures.
    • “The clearances add to the single port robot’s indications in urology, colorectal, thoracic and transoral procedures, as Intuitive works to expand adoption of the platform, launched in the U.S. in 2018.
    • “The SP system, for surgery through a single incision or natural orifice, is designed to help surgeons access narrow or deep spaces within the body to perform more complex procedures. The surgeon can control up to three multi-jointed instruments and a 3D-HD imaging endoscope through the entry point.”
  • Fierce Pharma relates,
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • “The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • “Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
    • ‘At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
  • STAT News tells us,
    • “Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, the Food and Drugs Administration hosted an expert panel to discuss the other sexual hormone with a potentially outdated black box: testosterone. 
    • “Nine experts, including academics, clinicians, and the CEO of a pharmaceutical startup focused on testosterone products, delivered lectures and answered questions highlighting the importance of testosterone as a marker of broader male health. They also promoted increased engagement with its therapeutic value and recommended changes in labeling and substance control.” 
  • Beckers Hospital Review shares background about and FDA review process.
    • “The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency has not formally issued draft guidance, recent public comments, advisory committee discussions and internal policy memos outline a framework that is intended to streamline clinical trials, tighten manufacturing oversight and modernize postmarket safety monitoring.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “South Carolina’s measles outbreak is “accelerating” in the wake of Thanksgiving travel and a lack of vaccinations, an epidemiologist for the state’s Department of Public Health (DPH) warned Wednesday, after authorities traced a sizable outbreak to a church in the state’s northwest.
    • “Of the 111 measles cases recorded in that area, known as the Upstate region, 105 involved people who were unvaccinated while three involved those who were partially vaccinated, state epidemiologist Linda Bell said at a news briefing. One dose of the vaccine is 93 percent effective against measles, while the full two-dose regimen is 97 percent effective, according to the Centers for Disease Control and Prevention.
    • “At least 254 people had been placed in quarantine as of Tuesday, 16 of whom are in isolation, the DPH said in a news release.
    • “Bell said that 27 new cases had been reported since Friday, bringing the total reported to the DPH this year to 114. “Accelerating is an accurate term. That is a spike in cases we are concerned about,” she said in response to a question from a reporter, adding that South Carolina has “lower than hoped for” vaccination coverage.”
  • NBC News tells us,
    • “Heart disease has long been the top killer of women in the United States, but new research suggests uterine fibroids, which many may not even be aware they have, could be putting them at a significantly greater risk.
    • “A large, 10-year study found that women with leiomyomas had an 81% higher long-term risk of heart disease than those without the common condition. Women with fibroids — generally benign tumors that can form on or in the uterus — also had higher individual risks of cerebrovascular, coronary artery and peripheral artery diseases a decade after diagnosis.
    • “The study involved more than 2.7 million U.S. women and was led by scientists at the University of Pennsylvania Perelman School of Medicine. It was published Wednesday in the Journal of the American Heart Association.
    • “We do hope that our study adds to this growing evidence that reproductive health may provide important insights into cardiovascular health,” said lead author Julia DiTosto, a doctoral candidate in epidemiology at Penn. “There is a need for more information on how exactly, biologically, these conditions are related and also identifying potential strategies for cardiovascular prevention.”
  • Per Healio,
    • “Younger age at diagnosis did not appear to affect outcomes among women with breast cancer who harbor BRCA mutations, according to study results presented at San Antonio Breast Cancer Symposium.
    • “In addition, survival did not differ between very young women — defined as 30 years or younger — and those aged 31 to 40 years.
    • “Age per se should not be considered a negative prognostic factor in BRCA carriers when appropriate treatment is provided,” Matteo Lambertini, MD, PhD, associate professor of medical oncology and consultant in medical oncology at University of Genova-IRCCS Policlinico San Martino Hospital in Italy, said during a presentation.”
  • Per Radiology Business,
    • “Targeting women who are eligible for both lung and breast cancer screening pays off, according to new research.  
    • “Numerous studies have explored poor LCS adherence, a problem less pronounced in screening mammography. One previous study estimated about 58% of LCS-eligible women reported having a mammogram over the past two years versus just 8% who underwent low-dose CT for lung cancer. 
    • “This presents a potential opportunity, experts detailed Dec. 1 in the Journal of the American College of Radiology. Researchers at two academic medical centers recently aimed to leverage mammography adherence to bolster LCS uptake and are finding success, with a significant uptick in total LDCT examinations. 
    • “It has been more than 10 years since annual screening for lung cancer was recommended, and screening rates still are disappointingly low. There are many reasons for these low rates, but mostly identifying eligible individuals is challenging in the primary care setting, and there is evidence showing a surprising lack of awareness about lung cancer screening among eligible individuals,” study co-investigator Robert Smith, PhD, with the American Cancer Society, which funded the analysis, said in a statement. “There is enormous potential here, and the ACS is thrilled with the outcome of this study.” 
  • Medscape discusses the rising number of double diabetes cases and “What Doctors Should Know About Viral Sleep Trends.”
  • Per Health Day,
    • “Many young Americans are still smoking nicotine, tobacco or cannabis, even as edibles and vapes continue to grow in popularity.
    • “A University of Michigan study looked at how 12- to 34-year-olds are using these substances today. Researchers examined data from 8,722 individuals who had used at least one of these products within the last 30 days.
    • “On average, users tried about two products during that time, and researchers identified six main patterns of use:
      • “Combustible tobacco: 31%
      • “Multiple forms of cannabis: 27%
      • “Vaping nicotine: 18%
      • “Using multiple forms of nicotine, tobacco and cannabis: 14%
      • “Cannabis edibles only: 5%
      • “Multiple forms of nicotine and tobacco: 5%
    • “The largest group, and still the most concerning, were people who smoked tobacco, researchers said.”
  • BioPharma Dive relates,
    • “An experimental Eli Lilly obesity medicine helped patients lose more than a quarter of their body weight while offering relief from knee osteoarthritis in a Phase 3 study released Wednesday.
    • “Patients on the highest dose of retatrutide lost an average of 28.7% of their body weight after 68 weeks of treatment, compared with 26.4% on the lower dose and 2.1% on placebo, Lilly said. Additionally, 39% of patients on the highest dose achieved weight loss of 30% or more and 24% of those on that dose saw their weight drop by 35% or more, Lilly said.
    • “Lilly has now produced a drug with the best weight loss results of any medication to date, Leerink Partners analyst David Risinger wrote in a note to clients. Before the release, Risinger said he was looking for weight loss in the mid-high 20% range, which would surpass the effects seen with Lilly’s tirzepatide, the world’s best-selling drug, sold as Zepbound for obesity.”
  • Per Genetic Engineering and Biotechnology News,
    • “In 2022, monkeypox virus (mpox) caused more than 150,000 cases—causing flu-like symptoms and painful rashes and lesions. The outbreak resulted in almost 500 deaths. At the time, vaccines developed to fight smallpox were repurposed to help the most vulnerable patients. But that vaccine—manufactured from a whole, weakened virus—is complicated and costly to make.
    • “Now, a major inroad towards a new and more effective way to fight monkeypox virus has been published. A team used the AlphaFold 3 model to identify a viral surface protein—OPG153—as a good target for developing new antibody therapies to treat mpox or for use in a vaccine. When mice were injected with the viral surface protein, the animals produced antibodies that neutralized the monkeypox virus, suggesting the breakthrough could be used in a new mpox vaccine or antibody therapy.
    • “This work is published in Science Translational Medicine in the paper, “Antigen-agnostic identification of poxvirus broadly neutralizing antibodies targeting OPG153.”
    • “Unlike a whole-virus vaccine that’s big and complicated to produce, our innovation is just a single protein that’s easy to make,” said Jason McLellan, PhD, professor of molecular biosciences at The University of Texas at Austin.”
  • and
    • “Findings from a new study led by scientists at Stanford University School of Medicine and their colleagues elsewhere show that a single signaling pathway controls whether immune cells attack or befriend cells that they encounter in the body. By manipulating this pathway, scientists may be able to tweak the immune response to treat a range of diseases, including cancers, autoimmune disorders, and more. Full details are provided in a new Nature paper titled “Erythropoietin receptor on cDC1s dictates immune tolerance.”  
    • “The findings build on work published in an earlier study by the same research group that described a role for erythropoietin (EPO) in the immune system—specifically, controlling how dendritic cells respond to real or perceived threats. The current study, which was performed in mice, helps to illuminate an aspect of peripheral immune tolerance, which is responsible for preventing inappropriate attacks on healthy tissue. The scientists who discovered regulatory T cells (Tregs), which are the key cellular players in peripheral immune tolerance, were awarded the 2025 Nobel Prize in physiology or medicine.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark and Blue Cross and Blue Shield Kansas City have announced plans to affiliate.
    • “The insurers revealed on Thursday that they will enter into an affiliation where Blue Cross KC will maintain its local brand and operations, but will be able to tap into Highmark’s resources to accelerate innovation for its members. Highmark is the fifth-largest Blues plan in the U.S.
    • “Through the affiliation, Blue Cross KC’s financial reserves and earnings will remain within its organization, and Highmark will support its evolution through administrative capabilities, technology and new tools to enable the insurer to build new products and operational efficiencies.
    • “Erin Stucky, CEO of Blue Cross KC, said in the announcement that after a “comprehensive” process to find a partner, the team is “confident” that Highmark was the right choice to “help us deliver greater value for our community.”
  • and
    • “Connecticut’s Office of Health Strategy (OHS) approved on Wednesday Hartford HealthCare’s Emergency Certificate of Need application to acquire two hospitals and related assets from the bankrupt Prospect Medical Holdings. 
    • “The expedited decision ensures continuity of care for Eastern Connecticut residents, while imposing specific conditions designed to ensure preservation of healthcare access and quality and control cost growth,” Amy Porter, the state regulator’s acting commissioner, said in an announcement. “The OHS staff conducted a rigorous and highly efficient process made possible by the emergency [certificate of need] statute.”
    • “Hartford HealthCare’s $86.1 million bid was the only one received for Manchester Memorial and Rockville General, and had previously been accepted by Prospect and green lit by a bankruptcy judge. The facilities had been at the heart of a now-settled legal dispute between bankrupt Prospect Medical Holdings and Yale New Haven Health, which prior to the bankruptcy had offered hundreds of millions more for the locations.”
  • and
    • “Aradigm Health, a new benefits platform aimed at easing the financial sting of coverage for cell and gene therapies, has launched out of stealth.
    • “The company is making its debut backed by a $20 million series A funding round that it intends to use to further enhance platform development, building out its team and growing its partnerships with payers and providers. The round was led by Frist Cressey Ventures with backing from Andreessen Horowitz and Morgan Health.
    • “Andreessen Horowitz led the company’s $5 million seed round in 2024 as well, according to an announcement.”
  • Healthcare Dive tells us,
    • “Elevance has added a former Pfizer executive to its board, the latest addition of pharmaceutical industry veteran as the insurer focuses on building its pharmacy services.
    • “Amy Schulman will start as an independent director of Elevance effective Jan. 12, the insurer announced Wednesday. Schulman will serve on the board’s audit and finance committees.
    • “Schulman’s “insight into the intersection of science, technology, and patient care makes her an exceptional addition as we continue to advance and expand our services,” Ramey Peru, chair of Elevance’s board, said in a statement.”
  • Beckers Hospital Review reports,
    • “Austin, Texas-based UT Health Austin intends to go live with a new inpatient Epic EHR on the same day it opens its new multibillion-dollar academic medical center.
    • “With the net-new implementation, the health system will be able to easily adopt many of the vendor’s latest AI and automation features.
    • “It is a really unique opportunity to build this from scratch, from the ground up,” UT Health Austin CIO Michael Ryan told Becker’s. “We’re really taking a fresh-eyes look at it. … We don’t have many existing legacy processes or legacy ways of working.”
    • “The $2.5 billion University of Texas at Austin Medical Center, slated to break ground in 2026, will include a new UT hospital and MD Anderson Cancer Center. Austin is currently the largest American city without an academic medical center.”
  • and
    • “U.S. News & World Report released its 2026 Best Hospitals for Maternity Care ratings Dec. 9, which also recognize hospitals providing services to underserved communities.
    • “The media company used self-reported maternity care data to identify 147 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack adequate access to such care.:”
    • The article lists all 147 identified hospitals by State.
  • and
    • “Many health systems are expanding their participation in value-based care models over the next few years, though few have substantial revenue at risk in value-based contract arrangements, according to a new Sage Growth Partners report. 
    • “The report, published Dec. 11, is based on a survey of 101 hospital and health system C-suite leaders from academic medical centers, integrated delivery networks and independent hospitals.’
  • Per an Institute for Clinical and Economic Research news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.
    • “Smoking cigarettes is the number one cause of preventable deaths in the US, and so any new therapy to assist with smoking cessation is extremely important,” said ICER’s Chief Medical Officer, David Rind, MD. “The drug we reviewed for this assessment, cytisinicline, is the same molecule as cytisine, a drug long used for smoking cessation in Eastern Europe. Our analyses show that cytisine/cytisinicline has similar efficacy but significantly fewer gastrointestinal side effects than varenicline, a common prescription drug used for smoking cessation in the US. We heard from experts that they are hopeful cytisinicline will be priced so as to be widely available to those who need it.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), on January 15, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Per MedTech Dive,
    • “Natera last week said it completed the acquisition of Foresight Diagnostics, expanding the company’s position in solid tumor molecular residual disease detection, particularly in lymphoma, a cancer of the lymphatic system.
    • “The all-stock transaction was valued at $275 million upfront, plus up to $175 million in revenue- and reimbursement-based milestone payments.
    • “Foresight’s PhasED-Seq technology will be integrated into Natera’s Signatera platform to further differentiate performance in solid tumors.”

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Tuesday report

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

From Washington, DC,

  • MedPage Today reports,
    • “The number of Americans signing up for Affordable Care Act (ACA) health insurance for 2026 is moderately higher than it was at a similar time last year, initial new federal data show, even as subsidies set to expireopens in a new tab or window at the end of 2025 will make the coverage more expensiveopens in a new tab or window for many.
    • “Seen at face value, the data from the Centers for Medicare and Medicaid Services seem to defy predictions that many Americans facing pricier plans would drop out of marketplace coverage altogether next year. But experts caution that the numbers are an incomplete snapshot of total enrollment, which could still show a decline by the end of the open enrollment period.
    • “Overall, it’s just too early to know what any of this means,” said Jason Levitis, a senior fellow in the health policy division at the Urban Institute.
    • “The data released Friday show that by day 29 of the window for Americans to shop for ACA plans this year, nearly 5.8 million people had picked one. That’s nearly 400,000 more enrollments than by day 30 of the open enrollment period last year.
    • Meanwhile, this year’s enrollment numbers are about 1.5 million lower than the 7.3 million or so people who had signed up 32 days into the open enrollment period 2 years ago, showing there is some fluctuation year to year in when people sign up for coverage.
    • “In most states, for Americans who want coverage to start Jan. 1, the window to shop for ACA coverage began Nov. 1 and ends Dec. 15. People who want their coverage to start later can continue to select plans through Jan. 15.”
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said he would hold a vote later this week on a Republican measure aimed at controlling healthcare costs, amid party division over how best to head off big price increases next year for millions of households.
    • “Thune said Republicans have coalesced around legislation from Sens. Bill Cassidy (R., La.) and Mike Crapo (R., Idaho) [discussed in yesterday’s FEHBlog post] that would put as much as $1,500 a year into tax-advantaged health savings accounts when paired with lower-priced insurance plans in 2026 and 2027. The proposal doesn’t extend enhanced Affordable Care Act subsidies, which are due to expire after this year.
    • “The measure aims to provide an alternative to a Democratic proposal that extends the ACA subsidies for three more years. Votes on the two plans in the GOP-controlled Senate are set for Thursday, as Thune follows through on a promise made to Democrats as a condition for ending the government shutdown last month.
    • “So there will be something out there that Republicans will be able to talk about and support and vote for, and then we’ll see what happens Thursday,” Thune said. If neither proposal gets the 60 votes required to advance in the Senate, he said, “then we’ll see where it goes from there.”
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking information from stakeholders regarding the American Medical Association’s (AMA) monopoly of Current Procedural Terminology (CPT®) codes and its impact on patients, providers, and health care costs. Cassidy is asking stakeholders with relevant experience and knowledge of CPT ® coding contracts with the AMA to inform the Committee’s inquiry by responding to this questionnaire.
    • “As chair of the HELP Committee, Cassidy is using all tools at his disposal to lower costs for American patients. Thus far, the AMA evaded questions and failed to cooperate with Cassidy’s inquiry. If the AMA does not respond in a fulsome and transparent manner by December 15, 2025, the Chairman is committed to finding answers by other means.
    • “The federal government mandated the use of CPT codes. This creates the potential for abuse in that if someone has to buy your product, you can charge them what you want,” said Dr. Cassidy. “There may be nothing wrong here, but we should get answers to make sure the CPT system is working for the American patient and for the American health care system.”
  • Beckers Hospital Review tells us,
    • “Nearly 4 million Medicare-eligible Americans face heightened risk of disrupted medication access as restructuring efforts by the U.S. Postal Service slow mail delivery in rural and underserved communities reliant on mail-order prescriptions, according to a Dec. 4 analysis from The Brookings Institution
    • “In 2024, USPS launched its Regional Transportation Optimization initiative, which consolidates mail processing into regional hubs. While the initiative aims to improve efficiency, early analyses suggest it has exacerbated delivery slowdowns in rural areas, according to the report.”
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 9 issued a proposed rule that would make changes to the Increasing Organ Transplant Access Model beginning July 1, 2026. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1 of this year. To comply with statutory requirements, CMS proposes to modify the eligible kidney transplant hospital criteria to exclude Department of Veterans Affairs medical facilities and military medical treatment facilities. The agency also proposes to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. Regarding IOTA participant performance, CMS proposes updates to the composite graft survival rate metric, including adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics. In addition, CMS proposes other policy changes related to repayments, the extreme and uncontrollable circumstances policy, transparency and public posting of information, voluntary health equity plans, beneficiary protections, monitoring activities, and remedial actions and termination.” 
  • Modern Healthcare relates,
    • “Health insurance companies spent two years getting ready for a new Medicare Advantage quality metric intended to tackle health disparities. Then the government pulled the plug.
    • “The Excellent Health Outcomes for All measure — also known as EHO4All and formerly known as the health equity index— likely won’t be part of the Medicare Advantage Star Ratings program in 2027 after all, the Centers for Medicare and Medicaid proposed in a draft regulation last month.
    • “It’s a mixed bag for the insurance sector. In conjunction with implementing EHO4All, CMS also planned to scrap the Star Ratings program’s so-called reward factor, which benefits companies that demonstrate high quality scores over multiple years. But other companies stood to gain from an emphasis on health equity. 
    • “Moreover, the industry at large carried out intensive preparations to boost their performance on EHO4All measures, which were intended to boost insurers that cover large numbers of beneficiaries who qualify for both Medicare and Medicaid, are eligible for low-income subsidies, or have disabilities.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has launched a safety review of approved respiratory syncytial virus therapies for infants, including Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck, Reuters reported Dec. 9.
    • “Senior executives from the three companies were informed last week that the agency would seek further data on the therapies following internal concerns raised by FDA officials appointed under Health and Human Services Secretary Robert F. Kennedy Jr. Tracy Høeg, MD, PhD, recently namedacting director of the FDA’s Center for Drug Evaluation and Research, initiated the safety inquiry over the summer. As a noted vaccine skeptic, the appointment of Dr. Høeg has raised serious concerns among healthcare experts.”
  • Bloomberg Law lets us know,
    • “The FDA’s effort to curb high drug costs by accelerating approvals of cheaper medicines similar to expensive biologics will need other policy reforms to boost access to the biosimilars, drug pricing experts say. 
    • “The Food and Drug Administration is seeking to lower drug costs by simplifying the development of biosimilars, products that are highly similar to FDA-approved biologics, have no clinically meaningful differences, and can treat patients the same way. Biologics, such as AbbVie Inc.‘s blockbuster treatment Humira for rheumatoid arthritis and Merck & Co.‘s cancer medicine Keytruda, are complex drugs made from sources such as plant or animal cells. 
    • “Biosimilars are often available at a lower cost compared to biologics. While insurance varies for patients, the list price of Humira can run above $6,000 a dose. Amgen Inc.‘s Amjevita, a biosimilar to the inflammatory drug, can be purchased at either 55% or 5% below Humira’s list price.
    • “The FDA action, however, might not immediately yield patient access to the cheaper medicines without reforming other policies that seek to make biosimilars available upon approval, drug pricing experts say. Biosimilars often face hurdles before hitting the market, frequently due to patent litigation, agreements between drug companies to defer entry, and how they’re treated in health insurers’ prescription drug plans.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application.
    • “Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we’re entering a new era of manufacturing here at home,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security.”
    • “The Augmentin XR application demonstrated clear alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. This approval will also help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades.”
  • and
    • “The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “The FDA continues to exercise flexibility in the regulatory approach for rare diseases by considering all available data sources, including as appropriate data from expanded access programs, to facilitate the advancement of life-changing treatments while ensuring scientific requirements are satisfied.”
  • Per MedTech Dive,
    • “Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features.
    • “Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.
    • “The company has pushed back on the warning letter, however, arguing that blood pressure is a wellness feature. The FDA disagreed, saying blood pressure is inherently related to a medical diagnosis. 
    • “The FDA isn’t likely to concede on its challenge, experts said. Whoop’s skirmish with the FDA offers lessons on where to draw the line between wellness and medical features.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Justice Department is weighing a challenge to a deal between two of the largest companies offering software to small, independent pharmacies, as antitrust enforcers step up their focus on the health-care industry.
    • “The deal, which the companies didn’t publicly announce, involves the acquisition ofMicro Merchants Systems, the operator of pharmacy management software platform PrimeRx, by RedSail Technologies, said the people, who asked not to be named discussing a confidential matter. Micro Merchants is backed by TA Associates Management, while RedSail is the result of multiple acquisitions backed by investment firms including Francisco Partners. 
    • “Representatives of the companies met with DOJ antitrust chief Gail Slater in late November, said the people. Such meetings indicate significant government opposition to a deal, although they don’t always precede a federal lawsuit if the companies are able to make proposals that allay the agency’s concerns. Companies submit confidential filings to US authorities as part of a merger review process.”
  • STAT News relates,
    • “In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
    • “Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.” * * *
    • “Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines, according to legal experts following the issue.”
  • The Wall Street Journal brings us to date on Luigi Mangione’s evidence hearing in New York state court.

From the public health and medical / Rx research front,

  • ABC News reports,
    • “Concerns about the flu spreading in the U.S. are growing as the U.K. continues to see a spike in cases among children and young adults.
    • “The increased number of cases in the U.K., could be a predictor for the flu season in the U.S., according to ABC News chief medical correspondent Dr. Tara Narula.
    • “We know that England or other places can be a marker for what is going to happen here, because their flu season happens a few weeks earlier than ours,” Narula said on “Good Morning America” Monday, adding, “We have low numbers of cases so far but they are increasing.”
    • “Some hospitals are starting to implement flu season visitor restrictions, including the Detroit Medical Center and Children’s Hospital of Michigan, which are allowing, as of Monday, up to two visitors per patient and only those 13 years of age and older are permitted on inpatient hospital floors or in observation units.
    • “According to data from the Centers for Disease Control and Prevention, flu activity in the U.S. is up at least 7% in the last week, and so far, there have been nearly 2 million illnesses, 19,000 hospitalizations, and 730 deaths from the flu.”
  • The Green Science Policy Institute tells us,
    • “New research led by the California Department of Public Health and partners found that replacing foam-containing furniture made before 2014 would cut in half levels of certain harmful flame retardants in people’s bodies in just over a year. Published today in the peer-reviewed journal Environmental Pollution, the study is the first to show measurable health benefits from California’s 2014 furniture flammability standard update, which made it possible for manufacturers to comply without adding chemical flame retardants.
    • “Specifically, volunteers who swapped their old sofas and living room chairs for new, flame-retardant-free versions saw their blood concentrations of polybrominated diphenyl ethers (PBDEs) drop by half in just 1.4 years. Due to the overall declining use of these chemicals, levels in participants who did not replace furniture dropped as well, but two to four times more slowly. PBDEs are linked to cancer risk, hormone disruption, and neurodevelopmental effects. Epidemiological studies have shown that the average U.S. child has lost three to five IQ points from exposure to one PBDE. Further, a recent research paper estimated those with highest levels of this flame retardant in their blood had about four times the risk of dying from cancercompared with people with the lowest levels.
    • “This study shows that the update to California’s flammability standard not only changed what goes into furniture—it changed what goes into people’s bodies,” said co-lead author Kathleen Attfield, a Research Scientist Supervisor with the California Department of Public Health. “Through biomonitoring, we can assess how policy changes and consumer choices can work together to lower exposures to toxic chemicals.”
  • NBC News reports,
    • “Despite previous excitement around a potential link between GLP-1 drugs and a reduced risk of cancer, new research suggests the popular medications “probably have little or no effect” on a person’s risk of developing one of the 13 obesity-related cancers.
    • “The findings, published Monday in the Annals of Internal Medicine, may seem counterintuitive, said co-author Dr. Cho-Han Chiang, who conducted the study earlier this year as an internal medicine resident at Mount Auburn Hospital, a Harvard Medical School teaching hospital in Cambridge, Massachusetts.” * * *
    • “The new study has two major limitations, Chiang said. One is that none of the nearly 50 trials his team analyzed was designed to measure cancer outcomes.
    • “Dr. Kandace McGuire, chief of breast surgery at the Massey Comprehensive Cancer Center at Virginia Commonwealth University, said that might explain the counterintuitive nature of the findings.
    • “When you take a bunch of studies that weren’t looking at cancer risk and you throw them together, sometimes you find things that are contrary to what you would hypothesize,” said McGuire, who wasn’t involved in the research. “Some of that may be just the makeup of the studies, rather than the actual data itself.”
    • “From a cancer prevention perspective, I think more data is needed,” Chiang said, noting that there’s also a lack of data on GLP-1 usage among patients who already have cancer.”
  • Health Day points out,
    • “Laughing gas might live up to its name for people struggling with depression, a major new study says.
    • “Treatment with nitrous oxide can provide rapid relief for people with depression, especially those who aren’t helped by antidepressants, researchers reported recently in the journal eBioMedicine.
    • “This is a significant milestone in understanding the potential of nitrous oxide as an added treatment option for patients with depression who have been failed by current treatments,” senior researcher Dr. Steven Marwaha, an academic psychiatrist with the University of Birmingham in the U.K., said in a news release.
    • “This population has often lost hope of recovery, making the results of this study particularly exciting,” Marwaha added.”
  • Today was the last day of the 2025 American Society for Hematology conference.
    • Per BioPharma Dive,
      • “A regimen involving Johnson & Johnson’s dual-acting drug Tecvayli could be curative when used early in the disease course of people with multiple myeloma, according to data disclosed Tuesday.
      • “Released at the annual meeting of the American Society of Hematology in Orlando, the results come from a trial called MajesTEC-3. J&J in October claimed early success for the study, which evaluated Tecvayli alongside another J&J drug called Darzalex, against Darzalex and a standard combination in people whose disease had advanced after one to three treatment lines. But it didn’t provide specific details, saving them for a spotlighted presentation at ASH on Tuesday.
      • “According to those results, the Tecvayli-Darzalex combination cut the relative risk of disease progression or death by 83% when compared to Darzalex and other therapies. Progression was also uncommon for treatment recipients who went six months without relapsing. According to J&J, 90% of those enrollees were still progression-free three years after the study’s start, leading researchers to suggest the combination could have curative potential.
      • “The efficacy is truly remarkable with this combination,” said Surbhi Sidana, an associate medical professor at Stanford University and a trial investigator. “We can see a light at the end of our tunnel with all of these therapies for our patients, having maybe a functional cure in the future.”
  • BioPharma Dive adds,
    • “An experimental Novartis drug helped bring an autoimmune condition causing low platelet counts under control in a Phase 3 trial, further lifting the prospects of a therapy the company acquired in a multibillion-dollar deal last year.
    • “The drug, ianalumab, acts by destroying misfiring immune cells and blocking signaling that creates new ones. Novartis has been testing it in a disorder called immune thrombocytopenia, in which the body erroneously wipes out blood-clotting platelets. The company intends for the drug to work hand-in-hand with another therapy, Promacta, that it sells for the condition.”

From the U.S.healthcare business front,

  • Fierce Healthcare reports,
    • “Healthcare giant CVS Health boosted its outlook for the year as part of its investor day on Tuesday.
    • “The company said it now expects full-year revenues of at least $400 billion and earnings per share (EPS) between $6.60 and $6.70. Previous estimates projected at least $397.3 billion in revenue and EPS of $6.55 to $6.65.
    • “CVS also projects its compound annual growth rate to be in the mid-teens for the next three years, reflecting the efforts it’s made to improve performance at multiple units. For example, CVS said it’s on track to return to target margins at Aetna, and it’s driving sustained earnings at CVS Pharmacy.
    • “We are closing out 2025 with meaningful momentum across our businesses and we expect another year of strong earnings growth in 2026,” said Chief Financial Officer Brian Newman in a press release. “We are committed to doing what we say.”
  • Fierce Pharma tells us,
    • “Eli Lilly has unveiled the location of the third of its four large-scale manufacturing facilities that it plans to build in the U.S.
    • “The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce active pharmaceutical ingredients (APIs) for peptide and small-molecule medicines, including the highly anticipated GLP-1 weight-loss pill, orforglipron.
    • “Lilly plans to employ 450 at the complex, including engineers, scientists, operations personnel and lab technicians. The Indianapolis-based company expects to begin construction in 2026 and complete the facility in 2032. Lilly estimated that the project will also generate 3,000 construction jobs.”
  • Beckers Hospital Review informs us,
    • “Pfizer has entered into a global collaboration and license agreement with YaoPharma for the development, manufacturing and commercialization of YP05002, a small-molecule GLP-1 receptor agonist currently in phase 1 development for chronic weight management.
    • “YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical Group, will complete the ongoing phase 1 clinical trial and grant Pfizer exclusive worldwide rights to further develop and commercialize the therapy, according to a Dec. 9 news release.
    • “Pfizer will pay $150 million upfront and may pay up to $1.935 billion in development, regulatory and commercial milestone payments, along with tiered royalties on sales if the therapy is approved.”
    • Fierce Health relates,
      • “Artificial intelligence was a key theme in a session on how digital tools are changing the payer industry at this year’s Fierce Health Payer Summit.
      • “The panel took place last Thursday at the annual event and was moderated by Staff Writer Emma Beavins. The panelists spoke about the importance of improving payer-provider relationships and the member experience through AI and data-sharing.
      • “Consumers are used to the convenience offered by platforms like Netflix and Amazon, yet healthcare is lagging. AI can help streamline the member experience, including by surfacing transparent pricing. Doing so carries a high return on investment, Brittany Poche, director of solutions at revenue cycle management company Norwood, said. “Having that whole transparency and that experience, that is going to really move us,” Poche said on the panel.”

    Monday report

    David Ermer–ACA, Congress, FDA, Medical / Rx research, NIH, Rx coverage, SCOTUS, U.S. Healthcare–

    From Washington, DC,

    • Per a Senate news release,
      • “U.S. Senators Mike Crapo (R-Idaho), chair of the Senate Finance Committee, and Bill Cassidy, M.D. (R-Louisiana), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, unveiled the Health Care Freedom for Patients Act, historic Republican legislation to lower health care costs and give money directly to families to control their own care. This bill is an alternative to Democrats’ temporary COVID bonuses, which send billions of tax dollars to giant insurance companies without lowering insurance premiums.
      • “Giving billions of taxpayer dollars to insurers is not working to reduce health insurance premiums for patients,” said Senator Crapo. “We need to give Americans more control over their own health care decisions. This bill builds on the work we did in the Working Families Tax Cuts Act and will help Americans manage the rising cost of health care without driving costs even higher.”
      • “Instead of 100 percent of this money going to insurance companies, let’s give it to patients. By giving them an account that they control, we give them the power. We make health care affordable again,” said Dr. Cassidy.
      • “This legislation:
        • “Sends money to patients, not giant insurance companies;
          • “Americans on affordable bronze and catastrophic plans would access these dollars in a Health Savings Account (HSA).
          • “These funds cannot be used for abortion or dangerous gender transitions.
        • “Lowers insurance premiums by funding cost-sharing reduction (CSR) payments [beginning in 2027};
        • “Empowers Americans to choose the insurance plan that fits their needs by increasing access to low-cost catastrophic plans;
        • “Prevents illegal immigrants from accessing Medicaid by requiring states to verify citizenship and immigration status before coverage; and
        • “Stops taxpayer dollars from funding gender transition services under Medicaid and excludes them as an essential health benefit for plans sold on the Obamacare exchanges.” * * *
      • Click here for a one-pager.
      • Click here for bill text.
    • MedPage Today reports,
      • “Members of the Medicare Payment Advisory Commission (MedPAC) generally responded favorably Thursday to a draft recommendation to increase reimbursement in 2027 for physicians who treat Medicare patients — with one exception.
      • “The MedPAC chairman’s draft recommendation was to “increase payment rates for physician and other health professional services by 0.5 percentage points more than current law.” However, commission member Brian Miller, MD, MPH, of Johns Hopkins University in Baltimore, pointed out that last year, “[MedPAC’s recommended] physician fee schedule update … was a net update of 3%.”
    • Govexec tells us,
      • “The Trump administration laid out its plans to “end weaponized government” in its new management agenda released Monday. 
      • “The latest President’s Management Agenda includes goals to eliminate “woke” programs, downsize the government workforce and real estate portfolio, implement workforce reforms and modernize government technology, as well as targets to “annihilate government censorship of speech” and centralize government contracting.
      • “The agenda reflects much of the Trump administration’s longstanding priority to drastically reshape the government, an objective the White House focused on immediately after the inauguration through its Department of Government Efficiency.”

    From the Food and Drug Administration front,

    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  [The manufacturer is Gamida Cell Ltd.]
      • “This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one’s life course,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Severe aplastic anemia is a rare blood disorder that can be fatal, and the FDA remains committed to expanding treatment options for patients with this disease.”  
    • CNN adds,
      • “Medical technology company MED-EL announced Thursday [December 4] that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.”

    From the judicial front,

    • The Wall Street Journal reports,
      • “The Supreme Court seemed poised Monday to expand the president’s power to fire the heads of many regulatory agencies, even as one pivotal justice expressed a desire to insulate the Federal Reserve from political pressure.
      • “During 2½ hours of oral arguments, the justices probed the limits of President Trump’s assertion of virtually unfettered authority to remove agency leaders, despite federal laws that protect them from being fired over policy disagreements.
      • “Justice Brett Kavanaugh pointedly asked Solicitor General D. John Sauer about concerns from economists that a broad victory for Trump in the case would jeopardize the independence of the Fed’s board of governors.
      • “I share those concerns,” said Kavanaugh, a Trump appointee.
      • “Still, Kavanaugh and the other five conservative justices were, as expected, mostly receptive to the administration’s argument that the president is entitled to more control over dozens of regulatory bodies in the executive branch, such as the Federal Trade Commission and the National Labor Relations Board.”
    • The Supreme Court is expected to announce its decision toward the end of the current term in June 2026.

    From the public health and medical / Rx research front,

    • The Wall Street Journal reports,
      • “Brayan Garcia was driving along a highway in his red Toyota Corolla when he slammed into the back of a Ram pickup truck that was stopping at an intersection in West Texas.
      • “Garcia, 22, died at the scene of the early morning crash. His Corolla sustained heavy damage, its hood ripped off entirely. Debris was scattered across several lanes. But despite hitting the truck directly, the Corolla’s air bags never went off.
      • “Toyota had recalled Garcia’s car in 2020 over a dangerous defect that could stop its air bags from deploying. But Garcia’s vehicle hadn’t gotten the fix, like millions of others currently on the road. 
      • “From 2015 to 2024, about 12 million vehicles were recalled for safety defects that could result in air bags not deploying. These recalls—37 in total—included models made by General Motors and Ford as well as luxury brands such as Mercedes-Benz and Audi. 
      • “About 2.6 million, or around 22%, of affected vehicles remain unfixed, according to an analysis of the latest National Highway Traffic Safety Administration data by The Wall Street Journal.
      • “The Journal found 12 people, including Garcia, who died after crashes in Toyotas and other vehicles where the air bag was under recall, hadn’t been repaired and didn’t deploy. 
      • “The NHTSA data reveal a broader problem: Roughly one in three cars recalled for all reasons goes unfixed. The rate is roughly the same even for serious flaws such as failing brakes, engine fires or the air bag defects reviewed by the Journal.”
    • The New York Times relates,
      • “The statistics are incontrovertible: Since 1992, the diagnoses of eight cancers has doubled in the United States in patients under age 50, including cancers in the thyroid, anus, kidney, small intestine, colorectum, endometrium and pancreas, as well as the blood cancer myeloma. Other types, including breast cancer, also are on the rise.
      • “The magnitude and speed at which early onset cancer incidence has increased is unlike most cancer trends ever observed (the possible exception being cigarette smoking and lung cancer),” the American Association for Cancer Research said in its announcement of a special conference being held this week that will explore the rise in cancers among younger people.
      • “The sharp uptick has been agonizing for these younger patients and many of their doctors.
      • ‘The patients wonder: Why did I develop cancer? And how will my life be transformed by potentially excruciating treatments?
      • “Their doctors share these questions, and some have additional concerns: What if these cancers had never been detected? Are doctors offering treatments to younger patients with early-stage diseases that may do as much harm as good?”
    • The Washington Post tells us,
      • “Children who returned to in-person schooling during the coronavirus pandemic saw improvements in their mental health, according to a new study that found school reopenings were associated with significant declines in diagnoses of anxiety, depression and other conditions.
      • “The findings, the study authors say, underscore that the social structure and support schools provide protected children’s mental well-being during the pandemic.
      • “Researchers from the Harvard T.H. Chan School of Public Health and Elevance Health, which is a private health insurer in California, analyzed medical claims for more than 185,000 California children ages 5 to 18 between March 2020 to June 2021. Before schools reopened about 5,200 children had a mental health diagnosis and that numbers rose to 6,500 over the course of the pandemic.
      • “But the researchers said after schools reopened, trends in mental health diagnoses, medications and spending dropped relative to trends in schools that stayed closed.”
    • Health Day informs us,
      • “The U.S. stillbirth rate dropped slightly last year, offering some hope after several years of uncertainty, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).
      • “The report, released Dec. 3, found a 2% decline in stillbirths in 2024. Even with that improvement, nearly 20,000 pregnancies ended in fetal death. That’s equal to about 5.4 stillbirths for every 1,000 pregnancies lasting 20 weeks or longer.
      • “This is the lowest national rate seen in decades, although the CDC said that it does not necessarily break previous records.”
    • The American Medical Association lets us know “What doctors wish patients knew about strep throat.
      • “What is causing that sore throat? It could be strep, and it needs to be treated the right way. Two Ochsner Health physicians share more about strep throat.”
    • Per Healio,
      • “In an analysis adjusted for tobacco cigarette use, the likelihood for asthma and COPD significantly rose with daily cannabis inhalation over a 30-day period, according to results published in Journal of General Internal Medicine.
      • “I hope these results give clinicians more confidence in stating that there are serious concerns about negative health impacts of inhaling cannabis on the lungs,” Alison S. Rustagi, MD, PhD, adjunct assistant professor at University of California, San Francisco, told Healio.
      • “We don’t have enough information now to say there’s a causal link, but we also have reason to think that there may be harm to the lungs from cannabis,” she continued. “This is important for patients to know as they make health decisions.”
    • From the American Society of Hematology conference, now underway in Orlando, Florida,
      • Per BioPharma Dive,
        • “An experimental drug from Terns Pharmaceuticals is showing it may emerge as a threat to multiple established medicines for a slow-growing blood malignancy known as chronic myeloid leukemia. 
        • “According to results presented at the American Society of Hematology meeting on Monday, Terns’ drug, codenamed TERN-701, helped a majority of study participants with CML who had received previous treatments significantly reduce the number of diseased white blood cells in their bloodstream. The findings suggest the drug, a type of targeted, oral treatment, may eventually be competitive with widely used medicines like Novartis’ Scemblix, which is expected to generate more than $4 billion in peak yearly sales.”
      •  and
        • Eli Lilly was the last company to bring to market a so-called BTK inhibitor for leukemia and lymphoma. But study results revealed Sunday show Lilly’s medicine may be more effective — and potentially safer — than the oldest drug in its class. 
        • The data come from a study testing Lilly’s Jaypirca directly against AbbVie and Johnson & Johnson’s Imbruvica. Early results presented at the American Society of Hematology meeting suggest Jaypirca helped induce responses in more people with chronic lymphocytic leukemia or small lymphocytic lymphoma than Imbruvica. More definitive measures of impact — such as effects on disease progression and survival — are pointing in Jaypirca’s favor as well, though additional follow-up testing is needed to confirm those benefits.
        • “The results could be crucial in helping Lilly boost sales of Jaypirca as Imbruvica, which was launched in 2013 and has since been a regular blockbuster, approaches the end of its patent life.”
      • Per STAT News,
        • “With so-called menin inhibitors now approved for patients with certain types of advanced acute myeloid leukemia, research efforts are shifting to find uses for the genetically targeted drugs in newly diagnosed patients.
        • “Kura Oncology presented preliminary results today from a study that combines Komzifti, its menin-blocker, with two standard AML treatments. In an analysis that encompassed 40 patients with newly diagnosed, menin-susceptible AML, the triplet regimen showed a complete remission rate of 86% with a manageable safety profile.
        • “Syndax Pharma reported results from its own menin-inhibitor combination study in newly diagnosed AML patients on Saturday at the ASH meeting.”
    • Per Fierce Pharma,
      • “UCB plans to file for regulatory approval of Fintepla to treat a third epileptic condition “as soon as possible,” the company said, as it reported results of a phase 3 trial in patients with the ultra-rare cyclin-dependent kinase-like-5 (CDKL5) deficiency disorder.
      • “The study of 87 patients aged 1 to 35 with CDKL5 achieved its primary endpoint, as Fintepla demonstrated a statistically significant reduction in seizures compared with placebo. The trial also achieved two of its three secondary objectives, the Brussels-based company said at the American Epilepsy Society (AES) conference in Atlanta.
      • “Fintepla was first approved in 2020 to treat seizures associated with Dravet syndrome (DS), a rare, severe form of epilepsy that affects roughly 20,000 in the U.S. Two years later, Fintepla gained expansion into a larger epilepsy indication, Lennox-Gastaut syndrome (LGS), which affects approximately 48,000 in the U.S. In both indications, the cherry-flavored oral solution is cleared for patients age 2 and older.”
    • Per a National Institutes of Health news release,
      • “A study funded in part by the National Institutes of Health (NIH) has revealed important insights into the genetics of deposits in the eye, known as reticular pseudodrusen (RPD), that are linked to greater risk of vision loss among people with age-related macular degeneration (AMD). The study underscores that AMD is not one disease and highlights the need for novel treatment approaches.
      • “This study could help explain why drugs that target just the complement pathway have shown a minimal effect in slowing geographic atrophy,” said Anand Swaroop, Ph.D., chief of the Neurobiology Neurodegeneration and Repair Laboratory at NIH’s National Eye Institute (NEI) and a coauthor of the study report. “It’s clear that AMD involves multiple pathways that differentially synergize to generate distinct phenotypes.”
    • Per the Genetic Engineering and Biotechnology News,
      • “Terray Therapeutics has achieved its first discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb (BMS). Under the terms of the agreement, which began in 2023, Terray will discover and develop small molecule compounds against a set of targets nominated by BMS. BMS will subsequently assume responsibility for development and commercialization. 
      • “While therapeutic details of the milestone have not been disclosed, Terray describes the target as “novel and difficult to drug,” and representative of the company’s Experimentation Meets Machine Intelligence (EMMI) platform.”  
    • Beckers Hospital Review calls attention to “23 recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

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

    • Modern Healthcare unveiled its 2025 list of the top 100 most influential people in healthcare. Here are the top five:
      • 1. Sam Altman, co-founder and CEO, OpenAI
      • 2. Greg Adams, Chair and CEO, Kaiser Permanente
      • 3. Judy Faulkner, founder and CEO, EPIC Systems
      • 4. Stephen Hemsley, Chair and CEO, UnitedHealth Group
      • 5. Eugene Woods, CEO, Advocate Health
    • STAT News reports,
      • “Health insurance companies have lamented fast-rising medical expenses for more than two years. This year is no different as Americans continue to get more carethan insurers expected. 
      • “One of the main culprits of that higher spending: prescription drugs, and GLP-1s in particular.
      • “Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025. The proliferation of GLP-1s — the injectable drug blockbusters that lead to substantial weight loss — has played a leading role and has led insurers and employers to consider whether they should stop covering them completely.” * * *
      • “Cynthia Cox, a vice president at health policy and research organization KFF who has studied health care spending across all types of health insurance markets, said GLP-1s are pressuring pretty much every insurer. “It’s not all GLP-1s, but I think a lot of the growth is,” she said.” 
    • The Wall Street Journal adds,
      • “Drugmakers are moving to sell their medicines directly to patients, abandoning the middlemen they have long relied on.
      • “The shift is a huge departure from how pharmaceutical companies including Eli Lilly, Novo Nordisk and Pfizer have sold drugs for decades and threatens the multibillion-dollar business of firms that have traditionally filled prescriptions. 
      • “It is saving some patients hundreds of dollars off the cost of prescriptions because companies have been lowering the prices for drugs sold directly. 
      • ‘Meantime, drugmakers who have been rolling out the services in recent months see a big opportunity to boost sales, though they risk losing revenue if they don’t offset lower prices by selling to more patients. 
      • “For the first time, pharma is actually looking end-to-end at the full patient journey,” said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. “That is a very different mindset than has been the case for the last 50 years.”  
    • Brown & Brown has made available the 2026 edition of its Employer Health and Benefits Strategy Survey.
    • Fierce Healthcare tells us how “CommonSpirit Health is working to accelerate its recently launched turnaround plan.”
    • Cardiovascular Business points out,
      • “Edwards Lifesciences held its annual investor conference, predicting considerable sales growth in 2026 and highlighting the company’s continued momentum in the area of structural heart disease. Transcatheter aortic valve replacement (TAVR) and transcatheter tricuspid valve replacement (TTVR) are two areas expected to experience significant growth in the year ahead. 
      • “For 2026, Edwards Lifesciences is currently projecting overall sales growth of 8% to 10%  in addition to an adjusted earnings per share of $2.80 to $2.95. TAVR sales are expected to play a major role thanks to the continued success of its Sapien 3 platform and the planned JenaValve acquisition first announced in July 2024. In fact, the company projects TAVR sales to hit anywhere between $4.6 billion and $4.9 billion in 2026, good for a growth rate of 6% to 8%, respectively. Edwards Lifesciences also pointed to progress in the use of TAVR for patients with aortic regurgitation as a crucial step forward for patient care. 
      • “In addition, transcatheter tricuspid and mitral valve technologies are expected to hit sales of $740 million to $780 million, up 35% to 45% compared to 2025. On the tricuspid side of things, the company’s Evoque device for TTVR represents a particularly important piece of the puzzle, with two-year data on the valve expected by the second quarter of 2026.”
    • Beckers Payer Issues informs us,
      • “Elevance Health has rolled out its virtual assistant to 22 million commercial members, with a Medicare expansion planned for 2026.
      • “The tool, accessible through the Sydney Health app and affiliated plan websites, allows members to ask plain-language questions about coverage, costs, and providers. For example, members can inquire whether a surgery is covered and receive personalized cost estimates, a coverage breakdown, and a list of in-network providers, according to a Dec. 5 news release.
      • “The rollout is part of Elevance’s broader AI push across its operations. The company has deployed AI tools for internal workflows, call center automation, and clinical decision-making. The company has said it plans to invest several hundred million dollars in AI and digital initiatives.”

    Weekend update

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

    From Washington, DC,

    • The Senate is expected to pass S. Res. 520 which is bloc approval of over eighty nominations below the Cabinet or federal judicial level that require Senate approval.
    • Roll Call tells us about upcoming activities on Capitol Hill this week.
    • Modern Healthcare reports,
      • “States are using limited resources to mitigate the effects of rising health insurance exchange premiums and shrinking subsidies.
      • “Initiatives include financial assistance, reinsurance programs and intensified consumer outreach.
      • “Congress continues to debate whether to extend enhanced premium subsidies that expire at the end of the year.”
    • The New York Times relates,
      • “The new Dietary Guidelines for Americans will not arrive until early 2026, a representative for the Department of Health and Human Services told The New York Times on Thursday, marking a delay of the release of the government’s official advice on what to eat and drink for good health.
      • “For months, Robert F. Kennedy Jr., the nation’s health secretary, has promised to overhaul the guidelines. Federal law requires that they are updated every five years; the current edition was supposed to be replaced by the end of 2025.”
    • The Federal Benefits Open Season ends tomorrow December 8 on the following OPM established schedule:
      • “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 8, 2025 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) and Postal Service Health Benefits Program (PSHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 8, 2025.”
    • OPM’s Director Scott Kupor added a new post to his Secrets of OPM blog last Friday. Here is a link to the post which concerns employee performance management.

    From the judicial front,

    • Tomorrow, the U.S. Supreme Court will hold its oral argument in Case No. 25–332, captioned Donald J. Trump, President of the United States, et al. v. Rebecca Kelly Slaughter, et al. Amy Howe, writing in the SCOTUSBlog, offers an explainer about the case.
      • “On Monday, Dec. 8, the Supreme Court will hear oral arguments in Trump v. Slaughter, a battle that has been brewing, on one hand, since soon after President Donald Trump took office in January and, on the other hand, for years. At the center of the battle are laws that limit the president’s ability to fire the heads of independent, multi-member federal agencies like the Federal Trade Commission. The president and his supporters are proponents of a doctrine known as the “unitary executive” theory – the idea that the president should have complete control over the executive branch. Under this theory, the president should be able to fire any member of the executive branch, and laws – like the one at the center of this case – that restrict his ability to do so violate the constitutional separation of powers between the three branches of government.” 
    • Federal News Network adds,
      • “A three-judge panel ruled Friday that President Donald Trump’s firings without cause of Cathy Harris and Gwynne Wilcox, Democratic members on the Merit Systems Protection Board and the National Labor Relations Board, were lawful.
      • “The split 2-to-1 panel decision of the D.C. Circuit Court of Appeals has no immediate effect, since both Harris and Wilcox’s firings were finalized in May. But Friday’s ruling comes as the Supreme Court is expected to hear arguments [on Monday December 8] on whether to overturn a 90-year-old ruling known as Humphrey’s Executor — a decision that could expand Trump’s [and future Presidents’] power to shape independent agencies.”
    • These court decisions do not affect OPM which is considered an executive agency subject to Presidential authority.

    From the public health and medical / Rx research front,

    • The New York Time reports that a kidney recipient dies after transplant from organ donor who had rabies. Only four donors have transmitted rabies to organ transplant recipients since 1978, according to federal officials.
      • “Since 1978, four organ donors have passed rabies to 13 organ recipients, the report said. Of the 13 recipients, six who received treatment for rabies survived. The seven others, who did not receive treatment, died.
      • “Fewer than 10 human deaths are attributed to rabies each year in the United States, according to the C.D.C. More than 3,500 animals test positive for the virus annually.
      • “In 2024, a record 48,149 organ transplants were performed, according to the Organ Procurement and Transplantation Network, the United Network for Organ Sharing reported. The organs came from a total of 24,018 deceased and living donors.”
    • The Wall Street Journal informs us,
      • “Despite being among the great scientific breakthroughs of all time, vaccines are under fire as top government officials cast doubts on their safety. 
      • “But as doctors and vaccine deniers spar over the safety of vaccines, emerging evidence finds that some vaccines aren’t only good at preventing the disease or virus they target but also might have broader or even unrelated health benefits.” * * *
        • “The shingles vaccine might reduce dementia risk, with one study showing it averted one in five new dementia diagnoses over seven years.
        • “A Nature study found that some cancer patients who received the Covid-19 vaccine while undergoing immunotherapy had a greater survival rate than those who didn’t.
        • “The BCG tuberculosis vaccine is being studied for Alzheimer’s prevention and has been shown to decrease infant mortality.”
    • A Washington Post recounts undergoing a full body MRI as a preventive measure which by the way is not covered by health insurance.
    • From the American Society of Hematology conference, now underway in Orlando, Florida,
      • Per Fierce Pharma,
        • “Pfizer has unveiled phase 3 results that could help the company’s hemophilia drug Hympavzi level the playing field in its competition with Sanofi’s Qfitlia and Novo Nordisk’s Alhemo.
        • “After an FDA approval about a year ago for the treatment of hemophilia in patients without inhibitors, Pfizer now has detailed data showing prophylactic Hympavzi can outperform traditional therapies at controlling bleeding in patients with inhibitors.”
      • Per BioPharma DIve,
        • “Vertex Pharmaceuticals’ genetic medicine Casgevy hit an early goal in two late-stage trials focused on children with uncommon blood disorders, helping them avoid damaging vessel blockages and the need for transfusions in a setting expected to be among the first to receive an extra-speedy review from the Food and Drug Administration.
        • “The data, disclosed Saturday at the American Society of Hematology scientific meeting in Orlando, may help boost disappointing sales for Casgevy, the first therapeutic to use CRISPR gene-editing technology to modify human diseases. Casgevy is a cell therapy made from patients’ own tissues and engineered to embed in the bone marrow and stimulate a protein called fetal hemoglobin. In sickle cell disease, this protein prevents the characteristic bending that results in blockages, while, in another disorder called beta thalassemia, it can prevent anemia and the need for frequent transfusions.”
      • Per STAT News,
        • “With sales of its existing blood cancer CAR-T therapies weakening, Gilead Sciences needs anito-cel, its next CAR-T therapy for multiple myeloma — to succeed more than ever. 
        • “On Saturday at the annual meeting of the American Society of Hematology, the company and its partner Arcellx reported deepening and durable responses with no concerning safety issues in the latest analysis of a pivotal-stage clinical trial.
        • “Among 117 patients enrolled in the study, 96% showed a tumor response, with 74% of patients achieving complete remission, the companies said in a press release. 
        • “Anito-cel delayed the worsening of multiple myeloma in 67% of patients at 18 months. At the same time point, 88% of the multiple myeloma patients in the study were still alive. 
        • “None of the study participants experienced delayed neurotoxicity, including Parkinsonian symptoms and cranial nerve palsies, and there were no cases of enterocolitis, an inflammation of the intestines.”
      • and
        •  “Revuforj is a pill made by Syndax Pharma that blocks a protein called menin implicated in certain types of genetically altered acute myeloid leukemia, or AML, an aggressive and difficult-to-treat blood cancer that occurs when immature bone marrow cells fail to mature into healthy blood cells and instead start dividing uncontrollably.
        • “For now, Revuforj is approved for patients with menin-susceptible AML that is no longer responsive to other therapies. On Saturday, however, a researcher presented preliminary study results showing strong efficacy for an experimental Revuforj combination regimen in patients with newly diagnosed AML.”

    From the U.S. healthcare business front,

    • Kaufman Hall reports
      • “The most recent National Hospital Flash Report highlights stabilizing hospital margins, with a persistent gap in hospital performance, according to September 2025 data. Year to date margins range from 14.7% for hospitals performing at the top quartile to -1.8% at the lowest quartile, with the 50th percentile at approximately 2.9% when adjusted for the allocations to hospitals from corporate, physician, and other entities.
      • “September saw also month-over-month and year-over-year increases in inpatient discharges, patient days and emergency department visits. With patient volumes moderately increasing year over year, the ability of hospitals to manage patient throughput efficiently is more important than ever.”
    • Kaufman Hall also offers advice to hospitals and payers about recent and potential site neutral payment developments.
    • Modern Healthcare points out,
      • “Prime Healthcare Foundation has decided not to acquire two Prospect Medical Holdings hospitals in Rhode Island. 
      • “Prospect Medical Holdings has filed a motion to close the facilities if a buyer is not found.”
    • Per Becker Payer Issues,
      • “This year, Elevance Health began covering doula care for members of some employer-sponsored health plans. Cynthia Brown, MD, medical director and clinical lead for women’s health at Elevance Health, joined the Becker’s Payer Issues podcast for an upcoming episode on her team’s push for doula coverage.” 

    Thursday report

    David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, SCOTUS, U.S. Healthcare–

    From Washington, DC,

    • Modern Healthcare reports,
      • “Enhanced subsidies for health insurance exchange plans would be extended for three years under a plan Senate Minority Leader Chuck Schumer (D-N.Y.) announced Thursday.
      • “The enhanced premium tax credits for marketplace policies expire at the end of the year, leading to significant cost increases for exchange enrollees in 2026. The Senate Democrats who sided with the Republican majority to end the government shutdown last month secured a promise from Majority Leader John Thune (R-S.D.) to hold a vote on the issue, which is slated for next week.
      • “Schumer described the Senate measure, which mirrors a House Democratic plan, as a “clean” extension that wouldn’t make other changes to Affordable Care Act of 2010 programs.
    • Fierce Healthcare adds,
      • “Congress is running out of time to address the expiring Affordable Care Act subsidies before many individuals are exposed to massive cost increases Jan. 1, and new plans are emerging on the Hill to tackle the challenge.
      • “A bipartisan group of 35 legislators—including 15 Republicans—in the House has introduced a plan that would extend the tax credits for one year with some modifications, such as a new income limit, according to a report in The New York Times. 
      • “The proposal also includes a second shift in year two, implementing more substantial reforms such as eliminating $0 premium plans except in cases where there is a need. Each piece of the plan would require a separate congressional vote, the NYT reported.
      • “Rep. Josh Gottheimer, D-N.J., said the lawmakers are urging for a vote on the package by Dec. 18 to “get something done before premiums rise in January,” per the NYT. Most of the Republicans who have signed on to the package represent districts where the race is expected to be competitive in the midterms next year, according to the article.”
    • Per a Senate news release,
      • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, is cosponsoring legislation alongside Finance Chairman Mike Crapo (R-Idaho), Ranking Member Ron Wyden (D-Ore.) and 18 senators to improve accountability and oversight of pharmacy benefit managers (PBMs) and bring down the price of prescription drugs for Americans. Grassley is an original cosponsor of the legislation, called the PBM Price Transparency and Accountability Act.
      • “Iowans at my 99 county meetings are fed up with the high cost of prescription drugs, and for good reason. PBMs are driving local pharmacies in Iowa out of business and making it harder for Iowans to access the medications they need. That’s why I’m introducing legislation with my colleagues to put patients over pharmacy benefit managers by shining a light on the complex and opaque tactics these middlemen use. This landmark bill builds on the bipartisan legislation I spearheaded during my time as Finance Chairman, and includes several proposals I helped craft,” Grassley said.
      • “The Grassley–led provisions included in the bill would:
        • “Increase PBM reporting requirements to Medicare Part D plan sponsors and the Department of Health and Human Services;
        • “Require retail community pharmacies and certain other pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) survey; and
        • “Ban PBM spread pricing in the Medicaid program.”
    • Fierce Pharma tells us,
      • “The Centers for Disease Control and Prevention’s (CDC’s) newly reworked Advisory Committee on Immunization Practices (ACIP) met Thursday to finally offer its recommendations for a universal hepatitis B virus (HBV) vaccine for newborns, only to fall to the same pattern of debate and uncertainty that derailed its last attempt to vote on the matter.
      • ‘Day one of the ACIP’s meeting this week was meant to pick up where the committee left off on the HBV topic during its September meeting, when it scrapped its planned vote amid confusion on specific voting language. The committee was scheduled to officially clear the air with a vote Thursday afternoon, following a morning of discussion and commentary from stakeholders, according to the final agenda.
      • “Things didn’t quite go to plan, however. After a few hours of debate on the voting language at hand, the only vote that occurred Thursday was a 6-3 agreement on a motion to push back the HBV vote until Friday morning.” * * *
      • “A planned HBV vote Friday will further crowd the schedule for the day, which is set to include additional discussion on the childhood immunization schedule, comparisons to the Danish vaccine schedule and a presentation on “aluminum exposure” from childhood vaccines and potential implications for asthma later in life, the agenda reads.” 
    • The American Hospital Association News notes,
      • “The AHA released a report Dec. 4 that found patient safety in hospitals and health systems across the nation continues to improve. The report, which uses data analyzed by Vizient, examined key safety and quality metrics from the fourth quarter of 2019 to the second quarter of 2025. It found that despite caring for a sicker patient population, hospitals’ focus on safety led to improved patient outcomes and reduced infections.” 

    From the Food and Drug Administration front,

    • STAT News reports,
      • “The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. 
      • “While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. Makary said that while the agency will still require two in some cases, the default will be one trial.
      • “You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT by phone.” * * *  
      • “The agency will publish a press release soon, a spokesperson told STAT. Makary said the agency will also start updating policies to reflect the change, which could take three to six months. The change will take effect once the guidance is updated.”
    • Per an FDA news release,
      • “The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a chimeric antigen receptor CAR T-cell therapy that genetically engineers a patient’s own T-cells to target and kill cancer cells.”
    • Per MedTech Dive,
      • “Medtronic said Wednesday it obtained U.S. clearance for its Hugo system in urologic procedures, positioning the medtech giant to challenge Intuitive Surgical in the world’s largest robotic surgery market.
      • “In addition to the initial urology indication, which includes common procedures such as prostate removal, the company plans to extend use of the robot to more surgical specialties in the U.S. over time, with general surgery and gynecology expected to follow next.
      • “The Food and Drug Administration clearance “means there is now choice” for hospitals looking to expand their robotic programs, Rajit Kamal, Medtronic’s vice president and general manager of robotic surgical technologies, said in a statement.”
    • and
      • “Olympus has updated the instructions for a device used with endoscopes to prevent or control bleeding, the Food and Drug Administration said Wednesday.
      • “As of Oct. 1, Olympus had reported 113 serious injuries and no deaths associated with problems releasing or detaching its PolyLoop ligation loop device, according to the FDA and its Australian counterpart.
      • “The FDA categorized the correction as a Class I recall because of the potential for the problems to result in severe tissue injury, bleeding, perforation, additional surgical intervention, extensive procedural delays and hospitalization.”
    • Cardiovascular Business informs us,
      • “The U.S. Food and Drug Administration (FDA) has announced that Glycar SA, a South African medical device company, is recalling certain SJM Pericardial Patches with EnCap Technology due to potential issues with their strength and durability.
      • “The recall only covers one specific lot of these patches: lot T2502257. That lot included some devices that are 5 cm x 10 cm and others that are 9 cm x 14 cm. 
      • “The impacted lot may not meet the required tensile strength specification,” according to the FDA’s advisory. “Possible change in tensile strength is not detectable to the user intraoperatively. Postoperative loss of the patch’s mechanical properties causing dehiscence or rupture may require reintervention or reoperation, depending on the clinical indication that the patch was used for.”
      • “This is a Class I recall, which means the FDA believes using these devices could cause “serious adverse health consequences or death.” At this time, however, no serious injuries or deaths have been linked to the issue.”

    From the judicial front,

    • Bloomberg Law reports,
      • “The US Supreme Court cleared Texas to use a new Republican-drawn congressional map for next year’s election, bolstering GOP hopes of picking up as many as five new House seats in the state.
      • “Over three dissents, the justices lifted a lower court ruling that had blocked the map, which was drawn at President Donald Trump’s behest to help Republicans try to keep their House majority in the midterm election.
      • “The Supreme Court order applies only until the justices resolve the state’s appeal, and the decision doesn’t dictate whether the map can be used beyond 2026. 
      • “The unusual Texas mid-decade redistricting set off a partisan fight across the nation, prompting about a dozen states to either redraw their maps or consider doing so.
      • ‘It’s not clear whether Republicans will ultimately benefit from the frenzy. Californians voted in November to redraw that state’s districts, potentially flipping five House seats to the Democratic side. The new California map is being challenged in another case likely to reach the Supreme Court.”
    • Federal News Network relates,
      • “Federal employee unions are asking a court to block the State Department’s imminent plans to finalize layoffs for hundreds of employees, as well as reverse more layoffs than agencies have allowed under a spending deal that ended the recent government shutdown.
      • “The American Federation of Government Employees and the American Foreign Service Association are leading an emergency request for a temporary restraining order that would prevent the State Department from officially separating hundreds of employees from the agency.
      • “The emergency request, filed with the U.S. District Court for the Northern District of California, asks the court to bar the “imminent and unlawful execution” of hundreds of reduction in force notices the State Department sent this summer.”

    From the public health and medical / Rx research front,

    • STAT News reports,
      • “A single HPV vaccination appears just as effective as two doses at preventing the viral infection that causes cervical cancer, researchers reported Wednesday.
      • “HPV, or human papillomavirus, is very common and spread through sex. Most HPV infections clear up on their own but some linger, causing cancers that appear years later, including cervical cancer in women and rarer cancers in both women and men.” * * *
      • “The U.S. recommends two HPV shots starting at age 11 or 12 for most girls and boys — as the virus also can cause head-and-neck and other cancers. Catch-up shots are recommended for anyone through age 26 who hasn’t been vaccinated. The Centers for Disease Control and Prevention has reported about 78% of 13- to 17-year-olds have gotten at least one dose.”
    • The Washington Post adds,
      • “The American Cancer Society has endorsed self-collected vaginal samples for cervical cancer screening — a change medical experts say will help expand access and improve detection.
      • “The updated ACS recommendations, released Thursday, reflect advancements in disease detection and access to screening options in the United States. The guidelines say self-collection to test for human papillomavirus, or HPV, a sexually transmitted infection that causes nearly all cervical cancer cases, is an acceptable option. But clinician-collected cervical samples are still preferred. The recommendations also offer new guidance on when people can stop being screened for cervical cancer.
      • “Self-collection could be “a game changer” for increasing screening, said Jane Montealegre, an associate professor in the department of behavioral sciences at the University of Texas MD Anderson Cancer Center.”
    • Beckers Hospital Review informs us,
      • “The Anesthesia Patient Safety Foundation and the Institute for Safe Medication Practices issued a joint warning urging hospitals to eliminate vials and ampules of tranexamic acid from perioperative settings due to the risk of fatal wrong-drug, wrong-route errors, according to a news release shared with Becker’s.
      • “The warning follows multiple reports of mix-ups in high-risk areas such as the operating room, labor and delivery, and emergency departments, where intravenous tranexamic acid has been mistakenly administered intrathecally instead of local anesthetics such as bupivacaine or ropivacaine, a “never event” with a mortality rate of up to 50%, according to a Dec. 3 news release. Survivors may experience permanent neurological harm.
      • “In response, the FDA added a boxed warning to the drug’s label, clarified that tranexamic acid is contraindicated for neuraxial injection and updated administration instructions to emphasize intravenous use only.”
    • Per Healio,
      • “Approximately 54% of individuals in the U.S. are affected by a neurological disorder, with headache the most prevalent.
      • “Stroke, Alzheimer’s disease and related dementias were the leading causes of health loss.”
    • and
      • “Most common pediatric infections only need 5- to 7-day antibiotic courses, but many providers still provide 10-day courses.
      • “Matthew Kronman, MD, MSCE, offers tips for discussing treatment plans with parents.”
         
    • Per Health Day,
      • “A painkiller could be tricking doctors into misdiagnosing heart failure.
      • “Gabapentinioids cause fluid retention, leading to swelling in the legs and feet.
      • “Many doctors chalked this side effect up to more dire conditions like heart failure.”
    • Medscape considers the pregnancy puzzle facing women stopping GLP-1s.
    • Genetic Engineering and Biotechnology News reports,
      • “A new paper published in Science Translational Medicine describes an experimental drug capable of repairing DNA damage caused by disease. Developed by scientists at Cedars-Sinai, the potential treatment is a prototype for a new class of medications that fix tissue damage caused by heart attacks, inflammatory disease, and other conditions. Details of the drug, dubbed TY1, can be found in the paper titled “Augmentation of DNA exonuclease TREX1 in macrophages as a therapy for cardiac ischemic injury.”  
    • and
      • “The microbes inside our bodies not only help break down food but also impact our health. Yet their precise influence is not always understood, especially in the presence of prescription drugs. Researchers at Princeton University Department of Chemistry have now reported how one of the most abundant gut bacteria, Bacteroides dorei, responds to tetracyclines, a class of commonly prescribed antibiotics.
      • “Using a technology known as UPLC-MS-guided high-throughput elicitor screening (HiTES), Mohammad R. Seyedsayamdost, PhD, and colleagues, examined how the metabolome of this commensal bacterium responds to hundreds of FDA-approved drug molecules. The team’s findings indicate how newly characterized signals released by the bacterium in response to tetracycline antibiotics could aid the host’s immune response, inhibit pathogens, and restructure the gut microbiome.”

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

    • Beckers Payer Issues relates,
      • “The 12 months since UnitedHealthcare CEO Brian Thompson was fatally shot have been among the most turbulent in UnitedHealth Group’s history. The company has cycled through senior executives, disclosed billions in unexpected medical costs, confirmed it is under criminal investigation by the Justice Department, and watched its stock plunge by around 50%. Here’s where things stand as the year comes to a close.”
    • Modern Healthcare lets us know,
      • “Humana Inc. is working with billionaire Mark Cuban on a potential pharmacy partnership, Cuban and Humana’s chief executive officer said at a conference Thursday, a move that could step up pressure on larger pharmacy middlemen.
      • “The remarks at the Forbes health care conference were light on details of the collaboration. Cuban, through his Cost Plus Drugs company, sells mail-order medications directly to consumers for transparent prices. Humana, which primarily sells Medicare health plans, is also expanding its pharmacy business through its CenterWell division.
      • “Cuban said he was talking to Humana about “putting together direct-to-employer programs” that would bypass traditional layers in the drug supply chain.
      • “Humana CEO Jim Rechtin said he aimed to “simplify” the process of getting drugs from manufacturers to patients. “How do you get rid of all that complexity?” he said.”
    • Fierce Healthcare informs us,
      • “Over the summer, Aetna made a commitment to ease friction for both patients and providers.
      • “Now, the company is offering a look at the progress it’s made toward that goal. The insurer, a subsidiary of healthcare giant CVS Health, said in an announcement that it is leaning on technology to make bundled prior authorization determinations. 
      • “Previously, authorization requests for medical claims and pharmacy claims needed to be submitted separately. For instance, a patient seeking in vitro fertilization treatment would need to have a request sent for the procedure itself, followed by a second request for the necessary medications, Aetna said.
      • “Beginning in November, however, providers could submit medical prior authorization requests to Aetna, and if approved, the associated medications under the pharmacy benefit are also approved automatically.
      • “In addition, in the same month, Aetna rolled out a bundled prior authorization offering in the musculoskeletal space, according to the announcement. That offering includes key x-rays, knee arthroplasty procedures, non-opioid pain medications, durable medical equipment and inpatient admissions if needed.
      • “The insurer launched similar prior auth bundles for lung, breast and prostate cancer earlier this year, Aetna said.”
    • and
      • “Angle Health, a payer working with employers, has raised $134 million in an oversubscribed series B round.
      • “The round was led by Portage alongside existing investors Blumberg Capital, SixThirty Ventures, Y Combinator and others. The raise included a combination of debt and equity, bringing total funding to nearly $200 million. The company plans to continue scaling operations to meet surging demand for alternative payer products. 
      • “Powered by an integrated, artificial-intelligence-enabled platform, Angle Health offers a digital-first care navigation experience with customizable plans for employers. It integrates medical and pharmacy data, demographic information, real-time claims patterns and population health data to help employers spot risk and design interventions accordingly. 
      • “The healthcare benefits ecosystem wasn’t designed for the small-to-medium-sized businesses that employ nearly half of America’s workforce, and legacy technology can’t deliver on the efficiencies and savings unlocked by AI,” Ty Wang, co-founder and CEO of Angle Health, said in a press release. “We’re rebuilding healthcare infrastructure and care pathways to give all employers access to the comprehensive benefits historically reserved for large enterprises.”
    • Per MedTech Dive,
      • “Medtronic began the U.S. rollout on Tuesday of its latest insulin pump system paired with a glucose sensor made by Abbott. The partnership marks a new foray for Medtronic, which has typically paired its insulin pumps and pens with its own continuous glucose monitors in the past.
      • “Abbott and Medtronic announced the partnership last year, with Abbott developing a new glucose sensor exclusively for Medtronic. The sensor, called Instinct, has a 15-day wear time, longer than any of Medtronic’s current CGMs.” 
    • The New York Times reports,
      • “People are Uploading their medical records to A.I. chatbots
      • “Despite privacy risks and inaccuracy concerns, people are feeding blood test results, doctor’s notes and surgical reports into ChatGPT and the like.”
    • McKinsey & Co. explains how to “unlock value with process intelligence in healthcare and beyond.”
      • “Process intelligence gives organizations a clear view of how work really happens, helping them uncover inefficiencies, streamline operations, and lay the foundation for success in an AI-powered future.”

    Midweek Update

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

    From Washington, DC

    • Fierce Pharma reports,
      • “The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.
      • “Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.
      • “By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.”
    • The Government Accountability Office today published a report titled “Patient Protection and Affordable Care Act:Preliminary Results from Ongoing Review Suggest Fraud Risks in the Advance Premium Tax Credit Persist.”
      • “This report discusses the preliminary results of our work on fraud risk management in the advance premium tax credit—a subsidy that the government pays to insurance companies to make premiums more affordable for eligible Americans under the Affordable Care Act.
      • “So far, we’ve found that fraud risks have persisted since we first reported on this (2014-2016). For example, we were able to get subsidized insurance for fake enrollees. We also found some issues with enrollees’ Social Security numbers that could indicate identity fraud.
      • “The program’s fraud risks were last assessed in 2018, even though the program and its risks have since evolved.”
    • Similarly, on November 24, the U.S. Office of Personnel Management’s Office of Inspector General published a capstone report on the agency’s implementation of the Postal Service Health Benefits Program. One key issue regarding confirmation of dependent eligiblity remains open.
      • The FEHBlog’s internal control concern is that OPM fails to use the HIPAA 820 electronic enrollment roster transaction with FEHB and PSHB carriers. The HIPAA 820 transaction, whihc has been around since 2008, allows carriers to tell whether a particular enrollee is paying a premium and if so is paying the correct premium. Bear in mind that half of the FEHB enrollment is self only. The HIPAA 820 transaction will produces savings that would cover the cost of implementation.
    • FedWeed reminds us,
      • Flexible spending account “participants may carry over part of the account for use in the next year, so long as they have accounts for that following year. For unspent 2025 money carried into 2026, that limit is $660 (for unspent 2026 health care account money eligible to be carried into 2027, the limit will be $680).”
    • and
      • “Next Monday (December 8) is the last day of the current open season to enroll or change coverage for 2026 under the FEHB and PSHB health insurance programs and the FEDVIP vision-dental insurance program, or to newly enroll or re-enroll in the FSAFEDS flexible spending account program.”
    • Per an OPM news release,
      • “The U.S. Office of Personnel Management (OPM) today announced the release of a new mandatory training program, “Performance Management for Supervisors,” designed to equip federal supervisors with the essential skills needed to lead high-performing, engaged teams.
      • “The training, now available through the Federal Performance Management Toolkit focuses on an array of topics including employee recognition and awards, hiring and discipline, drafting effective performance goals, delivering meaningful feedback, and taking timely corrective action.”
    • Per an HHS news release,
      • “The U.S. Department of Health and Human Services (HHS) today announced strong actions to protect the rights of parents within the practice of pediatric medicine. HHS opened an investigation into a complaint that a Midwestern school illegally vaccinated a child with a federally provided vaccine without the parents’ consent by ignoring a religious exemption submitted under a state law. HHS also issued a Dear Colleague letter [PDF, 265 KB] reminding health care providers about federal law requiring them to provide parents access to their children’s health information. In addition, the Department directed the Health Resources and Services Administration (HRSA) to add a grant requirement stating that all funding recipients must comply with all applicable federal and state parental-consent laws for any services or care provided to minors at HRSA-supported health centers as a condition of receiving Health Center Program funds.”
    • The American Hospital Association News notes,
      • “The Centers for Medicare & Medicaid Services has updated its GitHub repository with new resources to help hospitals comply with changes to hospital price transparency requirements finalized in the Medicare hospital outpatient prospective payment system final rule for calendar year 2026.”
    • STAT News points out,
      • “A new health care advocacy group, which will represent the shrinking number of independent doctors in America, is launching Wednesday with an ambitious policy agenda.
      • “IndeMed, which expects to represent nearly 70,000 members at its launch, will take on a host of issues important to doctors wanting to resist the wave of consolidation in recent years, its leaders told STAT. The group’s agenda includes reducing the burden of prior authorization, promoting transparent and fair reimbursement from payers, encouraging new practice models, fighting consolidation, and reforming the No Surprises Act.
      • “The group, through its nonprofit and associated political action committee, will push for changes in Washington as well as in states, and plans to offer members a state-by-state advocacy playbook.”

    From the Food and Drug Administration front,

    • The Wall Street Journal reports,
      • “Former Food and Drug Administration commissioners said new vaccine standardsthreaten to put Americans’ health at risk and upend the agency’s scientific integrity.
      • “The 12 former FDA leaders criticized the agency’s actions under vaccine skeptic Health Secretary Robert F. Kennedy Jr., in a joint piece published by the New England Journal of Medicine Wednesday.
      • “The authors make up nearly all of the living former FDA commissioners and acting commissioners, including Dr. Scott Gottlieb, who served during President Trump’s first term, and Dr. Robert Califf, who helmed the agency during the Obama and Biden administrations. 
      • “The article takes aim at the FDA’s plans for new vaccine standards detailed by vaccine division director Dr. Vinay Prasad that the former leaders said would drastically change vaccine regulation and “undermine public interest.” 
      • “In an email to staff last week, Prasad said the FDA will change its annual flu vaccine framework and require companies to submit larger studies about the effects of administering several vaccines at once.” 
    • STAT News tells us,
      • “Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according to an announcement from the FDA.
      • “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg said in a statement. “This is an incredible opportunity to serve my fellow Americans.”
      • “Høeg’s appointment as the agency’s top drug regulator comes after director Richard Pazdur filed paperwork to retire at the end of the month.”
    • Healio points out,
      • “The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with spinal muscular atrophy and a confirmed mutation of the survival motor neuron 1 gene, according to the manufacturer.
      • “In a press release, Novartis said the FDA’s approval positions Itvisma (onasemnogene abeparvovec-brve) as the first and only gene replacement therapy available to treat individuals with spinal muscular atrophy (SMA), a rare neuromuscular condition, virtually across the entire lifespan.”
      • “Itvisma is administered with a one-time fixed intrathecal dose that does not require adjustment based on a patient’s age or body weight, per the release. The drug is expected to be available within the U.S. in December.”

    From the public health and medical / Rx research front

    • The University of Minnesota’s CIDRAP relates,
      • “The Centers for Disease Control and Prevention (CDC) today confirmed 30 more measles cases reported in the United States this past week, raising the national total to 1,828 confirmed cases so far in 2025. 
      • “Current US hot spots are Utah, Arizona, and South Carolina, where outbreaks among predominately unvaccinated or under-vaccinated people have led to community spread and widespread quarantines at schools. 
      • “In total, the country has had 46 outbreaks this year of three or more cases; for comparison, 16 outbreaks were reported during all of 2024.” 
    • Health Day tells us,
      • “As many as 1 in 4 breast cancers occur in women younger than 50, a new study has found.
      • “Among seven outpatient clinics in the New York region, 20% to 24% of breast cancers were found in women 18 to 49, according to results presented Monday at the Radiological Society of North America’s annual meeting in Chicago.
      • “This research shows that a significant proportion of cancers are diagnosed in women under 40, a group for whom there are no screening guidelines at this time,” researcher Dr. Stamatia Destounis, a radiologist with Elizabeth Wende Breast Care (EWBC)  in Rochester, New York, said in a news release.
      • “The U.S. Preventive Services Task Force recommends mammography every other year starting at 40 and continuing through age 74, researchers noted. 
      • “The American Cancer Society recommends annual mammograms starting at age 45, but added that women can choose to begin breast cancer screening as young as 40.”
    • MedPage Today reports,
      • “Vaccination against herpes zoster, or shingles, was tied to fewer deaths among people with dementia, an analysis of data in Wales showed.
      • “Dementia patients who received the live-attenuated zoster vaccine (Zostavax) had a 29.5 percentage point decrease (95% CI 0.6-62.9, P=0.046) in dementia-related deaths over 9 years, reported Pascal Geldsetzer, MD, PhD, of Stanford University in California, at the annual Clinical Trials on Alzheimer’s Diseaseopens in a new tab or window (CTAD) annual meeting. The findings were published simultaneously in Cellopens in a new tab or window.
      • “Zoster vaccination also was tied to a drop of 3.1 percentage points (95% CI 1.0-6.2, P=0.007) in mild cognitive impairment cases during that period, Geldsetzer added.
      • “Our findings suggest that the live-attenuated herpes zoster vaccine has a beneficial effect at both ends of the disease course of dementia,” he said.
      • “They also hint that the shingles vaccine might slow dementia progression, he noted.”
    • BioPharma Dive reports,
      • “Data from a closely watched study evaluating Bristol Myers Squibb’s mind-stabilizing medicine Cobenfy in patients with Alzheimer’s disease could now come a year later than expected.
      • “In late July, Bristol Myers executives said they were reviewing the company’s near-term clinical trials to ensure the “timely delivery” of results with the “highest probability of success.” The review included “ADEPT-2,” a late-stage experiment exploring whether Cobenfy, which is already used to treat schizophrenia, may also have positive effects on the moderate to severe psychosis that often accompanies Alzheimer’s.
      • “On Wednesday, Bristol Myers disclosed that it had identified “irregularities” in the way the study was conducted at a “small number” of sites. This discovery prompted the company to not only exclude patient data from those sites for the study’s primary analysis, but, after consulting with the Food and Drug Administration, also bring in an “independent party” to assess the data that had been collected.
      • “Based on that party’s findings, a data monitoring committee recommended the trial keep going and enroll more participants so as to hit its original target. Bristol Myers is following this advice. ADEPT-2 had recruited around 400 patients across 119 locations, according to its listing on a federal database of clinical trials.
      • “The company now expects results to come by the end of 2026.”
    • and
      • “Pharvaris said Wednesday its pill for the rare swelling disorder hereditary angioedema succeeded in a Phase 3 trial, helping to begin relieving symptoms of an attack within 1.28 hours, significantly faster than a placebo.
      • “The Netherlands-based biotechnology company said it plans on asking the Food and Drug Administration in the first half of 2026 to approve deucrictibant. An extended release formulation of the medication is also in a Phase 3 trial to test whether it can prevent HAE attacks, with data expected next year.
      • “If approved, deucrictibant would be entering an increasingly competitive market. The first oral HAE drug to relieve attacks, Kalvista’s Ekterly, got an FDA nod this year, while two injectable drugs, including one to relieve attacks, also recently launched.”

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

    • Modern Healthcare lets us know,
      • ‘Startup health insurance company Curative has raised more than $150 million in a funding round that pushes the company’s value at about $1.28 billion.
      • “Curative works to address skyrocketing employer health insurance expenses as inflation, pricey drugs and chronic diseases drive up costs.
      • “The company expects 2026 to be its first profitable year since the pandemic, and projects $570 million in revenue for this year.” * * *
      • “Curative’s approach differs from typical insurers. It eliminates cost-sharing like copays and deductibles for care in its network, as long as members complete an annual visit with a primary care provider and a “navigator” who guides their care, said Fred Turner, the company’s co-founder and chief executive.”
    • and
      • “Direct-to-consumer telehealth company Hims & Hers Health said Wednesday it has agreed to acquire YourBio Health, a medical device company that develops blood sampling technology.
      • “Financial terms of the transaction were not disclosed. 
      • “The deal is slated to close early next year pending customary closing conditions, according to a release.” * * *
      • “The acquisition will allow Hims & Hers to add YourBio Health’s TAP device, which uses smaller, thin needles to collect capillary blood samples in a way that differs from traditional methods, into its offerings. 
      • “YourBIO CEO Paul Owen and Chief Scientific Officer Dr. Michael Mina will join Hims upon completion of the deal, the company announced.”
         
    • The American Hospital News tells us,
      • “The AHA Dec. 3 released its 2026 Health Care Workforce Scan — an annual snapshot of America’s hospital and health system employment based on reports, studies and other data sources from leading organizations and researchers. It also offers insights and strategies from peers and experts on navigating the future of the health care workforce.”
    • Beckers Hospital Review identifies five health systems launched this year.
    • Per MedCity News,
      • “Samsung Healthcare unveiled a new ultrasound system this week designed to boost diagnostic accuracy and efficiency. 
      • “The system, named the R20, finally brings the full weight of Samsung Electronics’ AI and semiconductor capacity into an ultrasound platform, said Tracy Bury, chief commercial officer and vice president of global growth initiatives at Samsung Healthcare during an interview Tuesday at the Radiological Society of North America’s annual conference in Chicago.
      • “The R20 system pairs Samsung’s imaging hardware with improved beamforming software, which helps produce sharper, more consistent images, she stated. It supports a wide spectrum of imaging use cases, such as abdomen, thyroid, musculoskeletal, vascular, breast, gynecology and urology.” 
    • “MedTech Dive discusses “PitchBook: AI tuck-in deals to drive M&A acceleration in 2026. Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.”
      • “The medtech industry is approaching 2026 in an improving position, with investors increasingly optimistic and funding rebounding, PitchBook said in its outlook for next year.
      • “PitchBook analysts said strategic investors are targeting companies that are approaching clinical milestones in cardiology, orthopedics and diagnostics. The analysts named neurostimulation, artificial intelligence-powered surgical navigation and precision medicine as other top areas to watch.
      • “Tariffs on China-sourced components are a manageable, persistent headwind, the analysts said, but the potential for more levies is a risk. PitchBook sees Medline’s planned initial public offering as a strong indication that tariff uncertainties are now less top of mind.”

    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.”