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.”