First FEHBlog Report of 2026

OPM

First FEHBlog Report of 2026

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

Happy New Year!

From Washington, DC

  • OPM Director Scott Kupor added a post to his Secrets of OPM blog about return to office policies.
  • Federal News Network reports,
    • “The specifics of a larger federal pay raise for law enforcement officers are coming into view, following President Donald Trump’s directive to offer a 3.8% salary increase for certain positions.
    • “In a memo Wednesday, the Office of Personnel Management established new “special salary rates” for federal law enforcement personnel [December 31], as a way to implement the bigger raise for 2026.”
  • MedPage Today tells us,
    • “The FDA approved tradipitant (Nereus), an oral neurokinin-1 (NK-1) receptor antagonist, to prevent vomiting induced by motion in adults, Vanda Pharmaceuticals announcedopens in a new tab or window Tuesday.
    • “The approval marks the first new drug treatment for motion sickness in over four decades and signifies an advancement in understanding motion sickness mechanisms, the company said.”

From the judicial front,

  • Federal News Network reports,
    • “The Trump administration is facing a new legal complaint from a group of government employees who are affected by a new policy going into effect Thursday that eliminates coverage for gender-affirming care in federal health insurance programs.
    • “The complaint, filed Thursday [with the Equal Employment Opportunity Commission] on the employees’ behalf by the Human Rights Campaign, is in response to an August announcement from the Office of Personnel Management that it would no longer cover “chemical and surgical modification of an individual’s sex traits through medical interventions” in health insurance programs for federal employees and U.S. Postal Service workers.
    • “The complaint argues that denying coverage of gender-affirming care is sex-based discrimination and asks the personnel office to rescind the policy.” * * *
  • Bloomberg Law informs us,
    • “Drugmakers Eli Lilly & Co., Novo Nordisk Inc., and Sanofi-Aventis US LLC and pharmacy benefit managers such as Express Scripts won’t face certain civil fraud claims in connection with alleged price-fixing of diabetes treatment drugs.
    • “The plaintiff health benefit managers and trusts were barred from asserting civil claims under the Racketeer Influenced and Corrupt Organizations Act because they didn’t directly purchase the drugs, but rather reimbursed their members for the cost, the US District Court for the District of New Jersey said Tuesday.
    • “The “indirect purchaser rule” developed by the US Supreme Court in the antitrust context holds that Clayton Act plaintiffs may not demonstrate injury by providing evidence only of indirect purchases.
    • “Judge Brian Martinotti said the rule also applies in RICO cases, citing recent decisions from the US Court of Appeals for the Third Circuit applying it in factual situations similar to that alleged here because RICO’s private cause of action was modeled on the Clayton Act.”

From the public health and medical / Rx research front,

  • Due to New Years Day falling on a Thursday, the Centers for Disease Control and Prevention released their respiratory news update last Tuesday, December 30.
    • “As of December 30, 2025, the amount of acute respiratory illness causing people to seek health care is at a high level for the first time in the current 2025-2026 season.
    • “Seasonal influenza activity is elevated and continues to increase across the country.
    • “RSV activity is elevated in many areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “COVID-19 activity is low but increasing nationally.”
  • STAT News relates,
    • “Babies who don’t get their first round of vaccines on time at 2 months of age are much less likely to get vaccinated against measles, mumps, and rubella by age 2, according to a new study that suggests pediatricians may have a narrow window in which to persuade parents to follow the recommended childhood vaccination schedule. 
    • “The study, published Friday in JAMA Network Open, reports that in the post-Covid-19 pandemic period, babies who didn’t get their shots on time at 2 months — the age at which the Centers for Disease Control and Prevention recommends babies get vaccines against a host of diseases — were more than seven times more likely not to receive their first measles, mumps, and rubella (MMR) shot by age 2, which is months later than when that shot is supposed to be given. Babies are supposed to get their first MMR shot between 12 months and 15 months of age, with a second sometime between the ages of 4 and 6.
    • “There’s evidence from this study that very early vaccination delays lead to later vaccination delays and even missed vaccination for measles,” said Nina Masters, an epidemiologist who is the lead author of the paper. “This shows that hesitancy is really starting early and has a long arc.”
    • “And as we look at a really bad measles year, it’s really important to do whatever we can to try to increase measles vaccination coverage.” 
  • Healio tells us,
    • “Early-onset preeclampsia was associated with increased risk for delayed early-childhood development in the domain of problem-solving among preterm children, researchers reported.
    • “Although other domains of child development were affected by hypertensive disorders of pregnancy (HDP) and its subtypes, the relationships were not statistically significant, according to data published in JAMA Network Open.
  • MedPage Today recounts what happened with bird flu in 2025.
  • The Wall Street Journal lets us know,
    • “Move over weight loss and dry January. There’s a new popular New Year’s resolution in town: Enter the digital detox.
    • “Some people are aiming to reduce overall screen-time or social-media use (including yours truly). Others want to carve out regular no-screen days—OK, maybe more like time periods—or days or retreats.
    • “A survey by the digital-wellness app Opal (granted, a bit of a biased audience) found that 33% of 1,306 users said reducing screen times and being more present was their top New Year’s resolution, compared with 28% who aimed to lose weight. 
    • “Even teens are voicing a desire to reduce screen time. A Boston Children’s Digital Wellness Lab report cited results from a survey of more than 1,500 teens and found that 63% said they use their phones too much and 47% said they used apps or tools to manage phone use. 
    • “It’s high time we all cut down. There are growing signals it’s bad for our mental health—especially among adolescents and young adults.
    • “A recent study in JAMA Network Open found that when young adults did a social-media detox for a week they had a reduction in anxiety and depression symptoms, as well as less insomnia.”
  • The Washington Post points out,
    • A fatty particle can clog arteries just as surely as cholesterol but often goes undetected, striking seemingly healthy people unaware of the danger. Though tests are widely available, they aren’t routinely ordered — in part because there are no approved treatments for the genetic disorder.
    • Now, cardiologists waging a campaign against lipoprotein(a) say they are reaching a turning point. Five experimental drugs are in late stages of development and aim to prove that lowering levels of Lp(a) — pronounced “L-P-little-A” — reduces heart attacks and strokes. Results from the most advanced clinical trial are expected in the first half of 2026.
    • “Cardiologists, drugmakers and Wall Street analysts are optimistic that these new drugs can effectively treat a disorder that is estimated to affect about 20 percent of the world’s population. Even if they prove effective, the cost of a novel drug — as well as the scant public awareness of Lp(a) — could be a barrier to treating patients who might benefit.
    • “There are over a billion people on our planet that have elevated lipoprotein levels and that are at increased risk,” said Steve Nissen, a cardiologist at Cleveland Clinic whose team is leading trials on four drugs targeting Lp(a). “We will have a massive educational job to do.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Hartford HealthCare closed its $86.1 million purchase of two Connecticut cate care hospitals, the 249-bed Manchester Memorial and its 109-bed Rockville campus, plus their related assets, from bankrupt Prospect Medical Holdings on Jan. 1.
    • “The transaction comes after the system spent months securing regulatory and state approvals, which involved commitments to maintain certain services and limit its rate negotiations with payers during the next few years. The most recent of these, an agreement with Connecticut Attorney General William Tong, came on Dec. 29
    • “Hartford HealthCare said it also plans to invest $225.7 million over three years into the hospitals and their communities. These efforts, as highlighted in this week’s announcement, include additional hiring, stronger outpatient and ambulatory care services, 24/7 virtual primary care offerings and the reopening of a 30-bed behavioral care unit at Rockville.”
  • Reuters relates,
    • “Drugmakers plan to raise U.S. prices on at least 350 branded medications including vaccines against COVID, RSV and shingles and blockbuster cancer treatment Ibrance, even as the Trump administration pressures them for cuts, according to data provided exclusively by healthcare research firm 3 Axis Advisors.
    • “The number of price increases for 2026 is up from the same point last year, when drugmakers unveiled plans for raises on more than 250 drugs. The median of this year’s price hikes is around 4% – in line with 2025.
  • Genetic Engineering and BioTechnology News calls attention to “Seven Biopharma Trends to Watch in 2026.”
  • Beckers Clinical Leadership tells us
    • “Of the 650 U.S. hospitals designated as “Magnet” hospitals for nursing excellence, about 5% have earned the recognition more than six times. 
    • “The American Nurses Credentialing Center awards Magnet recognition to hospitals based on their quality of patient care and nursing excellence. As of Dec. 31, 33 hospitals have received six or more Magnet designations — representing just 0.54% of the nation’s 6,093 hospitals.”
    • The article lists those 33 hospitals by State.  

Happy New Year 2026

David Ermer–ACA, Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–

Happy New Year. This year is the 250th anniversary of our Nation’s independence. The FEHBlog resolves to keep posting as the 20th anniversary of the FEHBlog also occurs in 2026.

From Washington, DC,

  • Federal News Network reports,
    • “The Office of Personnel Management is addressing what have become growing concerns in Congress over the significant delays in federal retirement processing this year.
    • “In a letter sent Tuesday [December 30] to a group of House Democrats, OPM Director Scott Kupor touted the benefits of the new online retirement application (ORA) in helping to streamline processing, while at the same time arguing that outdated systems — not staffing levels — are to blame for the current challenges HR employees are facing.
    • “The main issues with federal HR, we have found, are not low staffing levels, but inefficient and outdated technology and antiquated, cumbersome regulations and processes,” Kupor wrote in the Dec. 30 letter, obtained by Federal News Network. “OPM under the Trump administration has done in a matter of months what the government failed to do for multiple generations: modernize the paper-based federal retirement system.”
    • “Kupor’s comments are a response to a Dec. 22 letter from Democrats on the Oversight and Government Reform Committee, which raised concerns about the significant delays retiring federal employees are currently experiencing. Those delays are largely due to a surge of retirement applications from employees who opted into the deferred resignation program (DRP) earlier this year.”
  • FEHBlog Observation: A related solution would be to simplify the highly complex retirement programs.
  • An OPM news release describes the agency’s other accomplishments in 2025.
  • Beckers Payer Issues identifies major federal and state healthcare policies that first take effect in 2026. The FEHB is hoping for significant deregulation of the FEHB and PSHB Programs which is the surest path to lower premiums and better competition.
  • Fedweek tells us,
    • “The 2026 general schedule pay raise as usual will take effect not at the start of the year but rather as of the first full pay period of the year—January 11-24 for most—and its impact won’t be seen in pay distributions until the one covering that pay period, which in most cases will be made about a week to 10 days after its end.
    • “The raise of 1 percent across the board for most, although 3.8 percent for certain law enforcement positions (pending an OPM review), also as usual will have an effect on pay caps and certain benefits.
    • “The GS pay cap is increasing from $195,200 to $197,200. That cap affects employees in the upper steps of GS-15 in about half of the GS localities, and the upper steps of GS-14 in the highest paid, the San Francisco-Oakland locality.”
  • FEHBlog observation — FEHB Open Season changes for annuitants take effect on January 1, 2026, while Open Season changes for employees takes effect on the first day of the first pay period of 2026, which is January 11, 2026. Open Season changes in the Postal Service Health Benefits program for all enrollees take effect on January 1, 2026.

From the judicial front,

  • Beckers Payer Issues reports,
    • “Health Care Service Corp.’s Blue Cross and Blue Shield of Texas filed a lawsuit against medical billing company Zotec Partners Dec. 18, alleging “abuse” of the No Surprises Act’s independent dispute resolution process, according to filings from the Eastern District of Texas’ federal court.
    • “The No Surprises Act aims to limit surprise billing, forming the resolution process to address payment disputes between insurance companies and out-of-network providers.
    • “BCBS of Texas accused Zotec of knowingly instigating “thousands” of disputes that were not eligible for arbitration, such as by submitting false information. The insurer said Zotec sometimes ignored state law, timelines for the IDR process and eligibility parameters for claims. “Batching” — or bundling multiple claims into one IDR process — has been another concern, with BCBS of Texas saying Zotec “overwhelms” the insurer by including 66 unique items or services on average.
    • “The complaint requested compensation and a court order that would block Zotec from launching ineligible cases going forward.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Alabama insurers issued the highest amount of medical loss ratio rebates to consumers in 2024, according to KFF.
    • “Under the ACA, if an insurer in the individual market spends less than 80% of premium revenues on clinical services and quality improvement, it is required to provide a rebate to customers, based on a 3-year average.”
  • Beckers Hospital Review points out,
    • “Cross-market mergers — transactions between health systems operating in separate geographic regions — are becoming a more prominent trend in hospital consolidation as organizations continue to shift toward multiregion operating models.
    • “Over the past year, several large systems have pursued cross-market deals to gain scale, diversify risk and strengthen payer negotiations, often in lieu of same-market mergers that face heightened antitrust scrutiny. 
    • “While these transactions typically do not eliminate local competition for patients, they are reshaping how health systems think about growth, leverage and long-term sustainability.”
  • MedCity News adds,
    • “Workforce pressures remained the dominant financial challenge for hospitals and health systems in 2025, according to data released this month by Kaufman Hall.
    • “Labor is still the largest expense for hospitals, with about 70% of organizations pursuing widespread efforts focused on staffing optimization.
    • “The interesting trend within the workforce setting is that more than half [of hospitals] are looking at the potential outsourcing of non-core activities. This has always been a trend in healthcare, but it seems to be increasing as people look to improve some of the non-core competencies, such as food service, revenue cycle, HR, etc.,” said Lance Robinson, managing director at Kaufman Hall.” * * *
    • “Beyond pay, hospitals are rethinking care models, Robinson added. They are placing more of an emphasis on team-based staffing, as well as investing in technologies like ambient AI to reduce administrative burden and help clinicians work at the top of their license.”

Monday Report

David Ermer–CMS, Medical / Rx research, No Surprises Act, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Dec. 29 announced $50 billion in funds awarded to all 50 states through the Rural Health Transformation Program. Beginning in 2026, states will receive first-year awards averaging $200 million to expand access to care, bolster the rural workforce, modernize facilities and technology, and support innovative payment and care delivery models. 
    • “Funds will be allocated over the next five years, with $10 billion available each year through 2030. Fifty percent of the funding is distributed equally among all approved states, while the additional 50% is allocated based on rural health needs and proposed impact.” 
  • Federal News Network informs us,
    • “Probationary federal employees are on track to see more restrictions when appealing any future terminations, according to a new proposal from the Trump administration.
    • “Under new proposed regulations from the Office of Personnel Management, fired probationary employees would only be able to appeal their termination if they believe it was due to discrimination based on “partisan political reasons” or “marital status” — or if their agency diverged from standard termination procedures.
    • “These limited grounds of appeal for probationary terminations reflect the historical principle that probationary periods serve as a critical evaluation phase for new federal employees, and thus that agencies should enjoy great flexibility in separating employees serving probationary or trial periods,” OPM wrote in its proposal, which is scheduled to be published Tuesday on the Federal Register.
    • “Generally, OPM’s regulations seek to alter both the latitude and method for probationary federal employees to appeal an agency’s decision to fire them. Along with limiting options for appeal, the proposal would put OPM in charge of adjudicating employees’ cases, rather than the Merit Systems Protection Board.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge issued a preliminary injunction against a new government pilot set to significantly shift how certain health-care providers access steeply discounted medicines from drugmakers, halting the program from going into effect Jan. 1, 2026.
    • “Judge Lance E. Walker of the US District Court for the District of Maine ruled Monday that hospital groups suing the US Department of Health and Human Services over its new 340B Rebate Model Pilot Program demonstrated they’ll suffer irreparable harm in order for the court to grant a temporary block on the plan.
    • “The order hands a win to the American Hospital Association, the Maine Hospital Association, and other safety-net health systems that sued the government Dec. 1, alleging violations of the Administrative Procedure Act because the health department ignored comments about shifting the program to a rebate model.”
  • and
    • “A series of class actions over the exclusion of coverage for GLP-1 weight loss drugs is testing several legal strategies against how health insurance plans decide which drugs to cover and why.
    • “The cases target health insurance giants CareFirst BlueCross BlueShield, CVS Caremark, the Cigna Group, and Elevance Health Inc., alleging they and their pharmacy benefit managers breached their fiduciary duties under the Employee Retirement Income Security Act by discriminating against people with obesity and illegally denying coverage for Eli Lilly & Co.’s Zepbound, the only drug approved for sleep apnea.
    • “The lawsuits highlight the broadening dilemma that insurers and employers face in deciding whether to cover the blockbuster shots, as their popularity surges and lower cash prices come available to consumers outside of health plans. But pressure for coverage is likely to increase as the list of conditions the drugs are approved for continues to grow and as a newly approved pill is poised to increase demand.
    • “There’s more policy momentum to scrutinize exactly these kinds of PBM practices on the whole,” said Elizabeth McCuskey, a health law professor at Boston University. “So I think this adds a little fuel to that fire.”
  • The Proskauer law firm adds,
    • “In another development in the ongoing litigation over the enforceability of Independent Dispute Resolution (“IDR”) awards issued under the No Surprises Act (“NSA”), two air ambulance providers, Guardian Flight LLC and Med‑Trans Corporation, have filed a petition for writ of certiorari with the U.S. Supreme Court, seeking review of the Fifth Circuit’s decision holding that the NSA provides no private right of action to enforce IDR awards.  The petition asks the Court to decide a key question that has divided federal courts across the country: whether the NSA permits providers to bring private causes of action to enforce IDR awards in court.  Should the Supreme Court grant cert, the outcome of the case could have broad implications for the enforceability of NSA arbitration awards, a key feature of the NSA’s regulatory framework.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “An NBC News/Stanford University investigation has found widespread declines in kindergarten vaccination against tetanus. In states that provided data back to 2019, more than 75% of counties and jurisdictions across the U.S. have seen downward trends in young children getting the diphtheria-tetanus-pertussis (DTaP) series of shots. The vaccine is first given to babies at 2 months.
    • “Because tetanus isn’t spread from person to person, there isn’t a herd immunity threshold, but reductions in vaccination rates leave more people vulnerable to the disease.”
  • The American Medical Association lets us know what doctors wish their patients knew about Wilson disease.
    • “Wilson disease is a rare genetic condition that causes copper to build up in the body, often damaging the liver, brain and other organs before symptoms are recognized. Early signs of the condition—also called Wilson’s disease and named for the British neurologist who described it in 1912—can be subtle or mistaken for more common conditions. Because of that, many people live with the disorder for years before receiving the diagnosis that can change the course of their health.”
  • The Washington Post relates,
    • “University of Pennsylvania researcher Ran Barzilay is a father of three. His first two children received cellphones before they turned 12. But this summer, as early results from his own study on screens and teen health rolled in, he changed course. His youngest? Not getting one anytime soon.
    • “Barzilay’s analysis of more than 10,500 children across 21 U.S. sites found that those who received phones at age 12, compared with age 13, had a more than 60 percent higher risk of poor sleep and a more than 40 percent higher risk of obesity.
    • “This is not something you can ignore for sure,” said Barzilay, a professor of psychiatry and a child-adolescent psychiatrist at the Children’s Hospital of Philadelphia.”
  • Medscape considers whether “Relative Fat Can Replace Mass BMI in Assessing Obesity?”
    • “Developed and validated in 2018 using data from the National Health and Nutrition Examination Survey (NHANES), RFM is a sex-specific anthropometric measure of obesity that estimates body fat percentage based on height and waist circumference using the following formula:
      • “RFM = 64 − (20 × height/waist circumference) + (12 x sex [0 for males and 1 for females])
    • “This simple calculation incorporates waist circumference as a proxy of visceral body fat while accounting for sex-based differences in fat mass. Multiple studies have shown RFM to be a superior and more consistent predictor of cardiometabolic risk and mortality. 
    • “Obesity cutoffs were derived from NHANES (1999-2014) data linking RFM with all-cause mortality. After adjusting for age, BMI category, ethnicity, education, and smoking status, this analysis suggested that higher RFM was associated with substantially increased mortality risk. Women with an RFM of ≥ 40% (40% body fat) and men with an RFM of ≥ 30% (30% body fat) had a 50% higher risk of death compared with women with an RFM of ≤ 35% and men with an RFM of ≤ 25%. Additionally, women with an RFM of ≥ 45% had nearly double the risk of death, whereas men with an RFM of ≥ 35% had more than 2.5 times the risk of death.”
  • The Wall Street Journal tells us,
    • “It’s the leading cause of disability and one of the most costly health challenges of our time: chronic lower back pain.
    • “Yet effective and safe treatments are few and far between, leading patients to try everything from supplements to acupuncture to cannabis for relief.
    • “Now, two new studies provide some of the most comprehensive evidence yet that THC—the psychoactive compound in cannabis that creates the high—in combination with other parts of the cannabis plant may provide safe and effective relief. The two large, Phase 3 clinical trials demonstrated that the THC product is safe and more effective at reducing chronic lower back pain than placebo or opioids.
    • “Unfortunately, the news, while promising, won’t provide immediate relief for the more than 70 million U.S. adults who suffer from chronic lower back pain. The product tested is expected to be available in parts of Europe next year, while the path to approval in the U.S. will require another clinical trial.”
  • Beckers Hospital Review identifies “eight recent drug shortages and discontinuations, according to the FDA’s drug supply databases.”

From the U.S. healthcare business front,

  • The American Medical Association reports,
    • “Physicians continue to use telehealth at far higher levels than they did before the COVID-19 public health emergency, but an AMA report shows that the practice setting in which a physician delivers care can influence how often they use the technology.
    • “Overall, 71.4% of physicians reported using telehealth in 2024. That figure is far higher than the 25.1% of physicians who used it prior to the COVID-19 public health emergency in 2018, though it is down from the 79% of doctors using telehealth in 2020, according to the AMA Policy Research Perspectives report, “Patient-Facing Telehealth: Use Is Higher Than Pre-Pandemic But With Great Variation Across Physician Specialties” (PDF).
    • “Among the physicians surveyed in 2024, here is how many said their practices used telehealth for these services:
      • “52.5%—managed patients with chronic disease.
      • “48.5%—diagnosed or treated patients.
      • “40.3%—provided care to patients with acute disease.
      • “25%—provided preventive care.
    • “However, the ownership of the practice a physician was a part of appeared to have an impact on those numbers. Physicians in hospital-owned practices were more likely to report using telehealth than physicians who were part of a private practice.”  
  • Beckers Hospital Review informs us,
    • “Chesterfield, Mo.-based Mercy Health recorded an operating income of $70.2 million (2.6% operating margin) in the first quarter of fiscal 2026, up from an operating loss of $7.5 million (-0.3% margin) during the same period last year. 
    • “Mercy reported total operating revenue of $2.7 billion for the three months ended Sept. 30, up from $2.5 billion during the same period last year. Patient service revenue totaled $2.4 billion, up from $2.2 billion. Capitation revenue was $150.5 million, up from $141.3 million.”
  • and
    • “Seven hundred fifty-six rural U.S. hospitals are at risk of closure due to financial problems, with more than 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through December 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.” 
  • Fierce Pharma points out,
    • “Following a feud with activist investor Deep Track Capital in the first half of 2025, vaccine developer Dynavax Technologies has rounded out the year by agreeing to sell itself to France’s Sanofi.
    • “To get its hands on the Emeryville, California-based company and its approved adult hepatitis B vaccine Heplisav-B, Sanofi will pay $15.50 per Dynavax share in cash, which works out to a total deal value of roughly $2.2 billion, the French pharma said in a Dec. 24 press release.
    • “The acquisition, which is expected to close in 2026’s first quarter, also grants Sanofi access to Dynavax’s promising shingles prophylactic Z-1018, which is currently in phase 1/2 testing and could eventually challenge GSK’s incumbent shot Shingrix, if approved.”

In notable death news,

  • The Wall Street Journal reports,
    • “Joel F. Habener, a Harvard University academic whose research paved the way for revolutionary weight-loss drugs Ozempic, Mounjaro and others, which analysts forecast will be the biggest blockbusters in pharmaceutical history, died Sunday in Newton, Mass. He was 88.
    • “Eileen Martin, a friend of Habener’s, said he died peacefully at home. She didn’t give a cause.
    • “Habener led research that discovered a hormone dubbed GLP-1. The hormone regulates blood sugar levels and would later become the key ingredient in Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro—drugs that proved a major advance in diabetes treatment and so effective at regulating appetite that people who take them have called them miracle cures for obesity. Others taking the drugs say they cure addictions to nicotine, alcohol and gambling.”
  • RIP 

Tuesday report

David Ermer–CMS, FDA, HSA, Medical / Rx research, Medicare, OPM, Patient safety, Rx coverage, U.S. Healthcare–

The FEHBlog will be on hiatus following today until next December 27 Cybersecurity Saturday. Merry Christmas and Jingle Bells to all.

From Washington, DC,

  • Federal News Network reports,
    • “There’s an old adage that tells someone to “put your money where your mouth is.” Well, Don Bauer is going all in at the Office of Personnel Management.
    • “Bauer wrote a column for Federal News Network criticizing OPM’s plans to consolidate and modernize human resources systems across the government. In his Oct. 30 column, Bauer wrote that OPM’s initial plan was “not modernization; it’s madness.”
    • “Now Bauer is in charge of that madness. Federal News Network has learned Bauer will join OPM on Jan. 12 as its new deputy associate director for workforce standards and data center (WSDC) in the HR Solutions (HRS) office. He will be leading the HR Line of Business, the quality service management office (QSMO) and human capital management core modernization effort.”
  • Good luck, Mr. Bauer.
  • Mercer tells us,
    • “In Notice 2026-5, IRS and the Treasury Department provide key details about health savings account (HSA) enhancements passed as part of the One Big Beautiful Bill Act (OBBBA) (Pub. L. No. 119-21), clearing the way for employers to continue offering telehealth and to begin offering direct primary care service arrangements (DPCSAs) to otherwise HSA-eligible employees.
    • “Effective for the 2025 plan year, OBBBA reinstated and made permanent COVID-19-era telehealth relief allowing HSA-compatible high-deductible health plans (HDHPs) to cover telehealth and other remote care services before the statutory minimum deductible is satisfied.
    • “Beginning Jan. 1, 2026, OBBBA also allows individuals enrolled in DPCSAs to remain eligible to make or receive HSA contributions and treats certain bronze and catastrophic plans as HDHPs.
    • “This article summarizes the Notice 2026-5 question-and-answer guidance, addressing significant topics such as which services the IRS will treat as “telehealth and other remote care services;” whether a DPCSA can separately bill for primary care services or offer services beyond primary care; and whether a bronze or catastrophic plan can be an HDHP if purchased using an employer-sponsored individual coverage health reimbursement account (ICHRA).
    • ‘Comments about the guidance are due March 6, 2026.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today a new voluntary test of a model that is designed to enable Medicare Part D plans and state Medicaid agencies to cover GLP-1 medications used for weight management and metabolic health improvement, while helping control costs for patients and taxpayers.
    • “The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that combines access to GLP-1 medications with access to evidence-based lifestyle supports to achieve better long-term health outcomes. The model represents a major step toward potential expanded access and affordability for millions of Americans. 
    • “Today’s announcement builds upon our historic Most Favored Nations drug pricing deals’ goal of democratizing access to weight-loss medication, which has been out of reach for so many in need,” said CMS Administrator Dr. Mehmet Oz. “These actions further the administration’s bold plan to reform our country’s health systems and Make America Healthy Again. With the BALANCE Model, we’re pairing breakthrough science with healthy living to cut costs while empowering Americans to take control of their health.”
    • “Under the model, CMS negotiates directly with pharmaceutical manufacturers of GLP-1 drugs for lower net prices and standardized coverage terms. Negotiation areas include: 
      • “Guaranteed net pricing and potential out-of-pocket limits for beneficiaries;
      • “Standardized coverage criteria; and
      • “Evidence-based lifestyle support offerings.”
    • “To learn more about the BALANCE Model, visit: https://www.cms.gov/priorities/innovation/innovation-models/balance.” * * * 
    • “Prior to the launch of the BALANCE model, CMS also plans to implement a new Medicare GLP-1 payment demonstration beginning in July 2026, which will serve as a short-term bridge to the model. This additional payment demonstration means that Medicare beneficiaries can start accessing these important medications at prices negotiated by the Administration as soon as possible.
    • “The GLP-1 payment demonstration will operate outside of the Medicare Part D benefit’s coverage and payment flow, which means that Part D Plan Sponsors will not carry risk for eligible GLP-1 products furnished under the demonstration. Beneficiaries enrolled in Medicare Part D who meet the negotiated access criteria will have access to these drugs. Under the demonstration eligible Medicare beneficiaries will pay $50 for a month of GLP-1 medications.
    • “CMS will provide additional information on the design and implementation of the GLP-1 payment demonstration in early 2026.
  • The Wall Street Journal points out,
    • “About half of 20 million Americans with FSA [healthcare flexible spending] accounts let some of their money expire each year.
    • “The average forfeited amount per individual is over $400, and unused FSA money generally returns to employers.
    • “FSAs offer tax savings; a worker in the 22% tax bracket contributing $1,500 could save as much as around $500 in taxes.”
  • Per an AHIP news release from December 18,
    • “AHIP’s Board of Directors has elected Jim Rechtin, President and CEO of Humana, as Board Chair effective January 1, 2026. Rechtin succeeds Pat Geraghty, who announced his retirement after 14 years leading GuideWell and Florida Blue effective December 31, 2025.
    • “I was proud to be part of AHIP’s work this year to unite our industry around voluntary commitments to simplify prior authorization – an important ongoing effort that shows what’s possible when health plans work together to deliver for patients. As Board Chair, I look forward to taking the same cooperative approach to helping health consumers navigate the system and access high-quality, affordable care,” Rechtin said.

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • “The FDA has expanded the indication of ferric maltol (Accrufer) capsules for the treatment of iron deficiency to include adolescents.
    • “The approval makes the drug the first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. It was first approved in 2019 for adults with iron deficiency.
    • “The expanded indication was supported by the phase III FORTIS trialopens in a new tab or window in which 24 patients ages 10-17 received age-based dosing of ferric maltol twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at 12 weeks. This would be the expected average increase in hemoglobin with one blood transfusion, the agency noted.”
  • MedTech Dive reports,
    • “Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
    • “The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.”
  • and
    • “The Food and Drug Administration said Monday it has issued a Class I recall notice regarding Medtronic’s removal of heart vent catheters.
    • “Medtronic previously asked customers to quarantine lots of its DLP Left Heart Vent Catheters in response to an issue linked to three serious injuries. The FDA published an early alert about the recall in August.
    • “The agency updated its notice this week to inform the public that it has classified the issue as a Class I recall.” 

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Infants given the monoclonal antibody nirsevimab, which provides temporary immunity to respiratory syncytial virus (RSV), had lower risks of related hospitalizations and severe outcomes than those whose mothers got the RSVpreF vaccine, according to a population-based study.
    • “The study may be the first to compare the two interventions in a real-world setting in a national population.
    • “The study and two others reported alongside it join a growing body of real-world evidence demonstrating the effectiveness of RSV products in protecting against severe outcomes related to RSV in the youngest kids.”
  • Health Day informs us,
    • “People on the verge of type 2 diabetescan cut their risk of death from heart disease by more than 50% if they bring their blood sugar levels back to normal, a new study says.
    • “Patients with prediabetes reduced their heart risk by up to 58% when they successfully lowered their blood sugar, researchers reported in The Lancet Diabetes & Endocrinology.
    • “This is an important finding, given that recent studies have concluded people with prediabetes can’t lower heart disease risk through lifestyle changes like exercise, weight loss and a healthy diet, researchers said.
    • “Essentially, reversing prediabetes by lowering blood sugar matters more to your heart than any healthy habits you adopt, researchers said.
    • “This study challenges one of the biggest assumptions in modern preventative medicine,” said lead researcher Dr. Andreas Birkenfeld, a reader in diabetes at King’s College London.
  • Medscape points out,
    • “A trio of large observational studies reported at the San Antonio Breast Cancer Symposium (SABCS) 2025 suggest that GLP-1 receptor agonists may improve outcomes in some women with breast cancer.
    • “Two studies reported an overall survival benefit of GLP-1 use in certain patients with breast cancer, including those with ductal carcinoma in situ (DCIS) and invasive hormone receptor (HR)-positive nonmetastatic disease, and a third found improvements in a range of toxicities among patients receiving chemotherapy.
    • “These studies, presented during a poster session, add to other emerging research indicating that GLP-1 drugs could have implications across the breast cancer trajectory, including prevention, active therapy, and posttreatment survivorship, explained study discussant Jasmine S. Sukumar, MD, with University of Texas MD Anderson Cancer Center in Houston.”
  • Fierce Pharma relates,
    • “Just days after an upbeat R&D event, Neurocrine Biosciences has found itself having to report a phase 3 failure.
    • “The company’s Ingrezza (valbenazine), approved to treat certain uncontrolled movement conditions, failed to make a significant difference in a phase 3 trial for patients with dyskinesia due to cerebral palsy (CP), Neurocrine announced Monday.
    • “Ingrezza didn’t outperform placebo on improving involuntary, jerky movements of the body after 14 weeks of treatment, causing the phase 3 trial to miss its primary endpoint. The study, dubbed Kinect-DCP, also did not meet key secondary endpoints, according to Neurocrine.”
  • and
    • “A patient in an open label extension study of Pfizer’s hemophilia treatment Hympavzi has died, the company and several hemophilia advocacy groups confirmed this week.
    • “Pfizer is now working with its trial investigator and independent data monitoring committee to accrue more information and better understand the circumstances behind the incident, the New York drugmaker wrote in a letter to the hemophilia community, which was posted online (PDF) by the World Federation of Hemophilia (WFH) on Dec. 22.”
  • STAT News reports,
    • “Oncologists have been moving away from the notoriously unpopular neutropenic diet. It requires nearly all food to be cooked to high temperatures — or, as some have described it, “boiled to death” — to reduce the risk of food-borne illnesses. But since evidence in recent years suggested the diet didn’t actually help ward off infections, doctors started leaning away from a strict neutropenic diet.
    • “Now, a new study published last week in the Journal of Clinical Oncology is giving some physicians pause about fresh fruits and vegetables for patients whose treatment involves heavy suppression of the immune system, particularly neutrophils, white blood cells that are key to preventing infection. Contrary to research in the past, the trial found that certain blood cancer patients who were allowed a less restrictive or liberalized diet had 11% more infections than patients who were prescribed the neutropenic diet.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Analysts expect health insurance companies to be better positioned for 2026 after adjusting their offerings.
    • “Medicare Advantage offers the sector the largest potential for improvement because companies will receive a significant increase in federal pay. 
    • “Federal changes to Medicaid and the exchanges will pressure health insurance companies’ finances.”
  • Ernst & Young informs us,
    • “A changing healthcare landscape is shifting economic returns, leading organizations to rethink their value chain position.
    • “Expansion in lower-acuity care and opportunistic mergers and acquisitions can accelerate long-term growth.
    • “Implementing new benefit cost containment strategies and investing in innovative AI solutions can elevate efficiency and performance.”
  • Per a Harvard Business Review article,
    • “U.S. employers are grappling with surging healthcare costs as healthcare prices and service volumes rise. Provider consolidation, high drug prices, labor shortages, and growing chronic disease are fueling the cost increases. Employer have largely responded by shifting expenses to workers. Their track record in pursuing aggressive options—including collective purchasing, tiered plans, value-based care, and advocating for changes in government policies—is poor. The big question is whether they have the will to become more aggressive in pursuing remedies. The outlook is not promising. The reasons include the complexity of the problem, employee resistance to some solutions, and the fact that most employers just don’t have sufficient “skin in the game” to take on the disruption and risk that would be required to bend the healthcare cost curve significantly or sustainably.”
  • The FEHBlog has more confidence in employers.

FEHBlog response to public comment

  • A commenter called into question the statistices upon which AHIP relied in this recent news release which the FEHBlog quoted. In response the FEHBlog notes that the AHIP news release was generated in response to the Affordable Care Act marketplace subsidy controversy and 2020 was an outlier year for all health insurers as it was the first year of the Covid pandemic. Health plans did make MLR rebates in that year according to CMS.

Monday report

David Ermer–CDC, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • OPM’s leadership posted an end of the year letter to OPM employees.
  • STAT News reports,
    • “Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so.
    • “Net drug prices — the amounts that health insurance companies and PBMs pay to drugmakers, after factoring in rebates — are highly valuable data that undergird the entire economic foundation of the U.S. pharmaceutical industry. But the decision from the Trump administration, rolled out in a new proposed rule, means that drug pricing data will likely remain locked out of public view for the foreseeable future.”
  • Avalere Health shares its perspective about December 2025 Advisory Committee on Immunization Practices Insights and 2026 Emerging Priorities.
    • “The ACIP’s December meeting resulted in a key change to the pediatric immunization schedule and signaled several potential changes to US vaccine coverage and access in 2026.”
  • Per an HHS news release,
    • “Executing on President Trump’s Executive Order (EO) 14192 titled “Unleashing Prosperity through Deregulation” and the President’s mandate to ensure the United States’ continued leadership in artificial intelligence (AI), the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), today released the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule.
    • “Today’s HTI-5 Proposed Rule has three core goals: (1) reducing burden on health IT developers by streamlining ASTP/ONC’s voluntary Health IT Certification Program by removing redundant requirements; (2) updating the information blocking regulations to better promote electronic health information access, exchange, and use so that patients’ access to their data is not blocked; and (3) advancing a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) that promote AI-enabled interoperability solutions through modernized standards and certification. The HTI-5 proposed rule is expected to save $1.53 billion in total, including $650 million over the next five years for health IT developers, providers, and other stakeholders.
    • “The HTI-5 proposed rule delivers on President Trump’s directive to reduce regulatory burden and to enable American innovation through artificial intelligence,” said Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health IT. “These proposals reflect a commonsense approach that removes redundant requirements on health IT developers, that better ensures seamless patient access to their information and that sets a foundation for AI-based data exchange.” * * *
    • “More information can be found at healthit.gov/hti5 and via ASTP/ONC’s X account, @HHS_TechPolicy
    • “ASTP/ONC is also withdrawing certain proposals not yet finalized from the HTI-2 proposed rule.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “U.S. regulators approved the first GLP-1 weight-loss pill—a tablet formulation of Novo Nordisk’s NOVO.B  Ozempic and Wegovy—ushering in a new era of the obesity-drugs revolution that is expected to broaden their use.
    • “Novo Nordisk said it plans to start selling the new pill in the U.S. soon after the new year, with a cash price of $149 a month for the starting dose.
    • “The Food and Drug Administration approval is a milestone because weekly shots such as Wegovy and Eli Lilly’s LLY Zepbound have dominated the anti-obesity market to date. Yet many people with excess weight don’t take the shots due to cost, spotty insurance coverage and fear of needles.
    • “Drug companies and analysts say pills will tap in to demand from people who don’t want an injection or would prefer the cadence of a daily dose. Pills also offer the prospect of lower prices and better health-insurance coverage than injections, because pills cost less to make.
    • “Eli Lilly also plans to introduce a new weight-loss pill, potentially within weeks or months.” 
  • Fierce Pharma tells us,
    • “Just two months after reviving its prowess in the idiopathic pulmonary fibrosis (IPF) treatment area with rare lung disease med Jascayd, Boehringer Ingelheim is already unlocking another patient population with a new FDA nod.
    • “The new approval for Jascayd in progressive pulmonary fibrosis (PPF) makes the drug the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication, according to a Dec. 19 company press release.
    • “Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” Boehringer’s head of human pharma, Shashank Deshpande, said in a release.”
  • MedTech Dive notes,
    • “Abbott said Monday that it has received Food and Drug Administration approval for its Volt pulsed field ablation system.
    • “The catheter-based device uses targeted, high-energy electrical pulses to treat a common heart arrhythmia called atrial fibrillation. Abbott’s Volt device is indicated for both paroxysmal AFib, where episodes come and go, and persistent AFib, or episodes that last longer than seven days, according to the FDA.
    • “Medtronic, Boston Scientific and Johnson & Johnson have all debuted their own PFA devices in the last two years. The approval allows Abbott to join the fast-growing, competitive market in the U.S.”

From the public health and medical / Rx research front,

  • The American Medical Association lets us know “What doctors wish patients knew about family immunizations.”
    • “Vaccines save millions of lives each year. Two infectious diseases physicians discuss the key role they should play for the loved ones in your family.”
  • Health Day informs us,
    • “Psychiatric conditions as varied as schizophrenia and bipolar disorder might be driven by very similar genetic underpinnings, a new study says. 
    • “Mental health problems can be sorted into five general genetic categories, each with a shared “genetic architecture” driving people’s illness, according to results published in the journal Nature.
    • “Right now, we diagnose psychiatric disorders based on what we see in the room, and many people will be diagnosed with multiple disorders. That can be hard to treat and disheartening for patients,” lead researcher Andrew Grotzinger, an assistant professor of psychology and neuroscience at the University of Colorado-Boulder, said in a news release.
    • “This work provides the best evidence yet that there may be things that we are currently giving different names to that are actually driven by the same biological processes,” he said.”
  • and
    • “A new risk score can help predict which pancreatic cancer survivors are more likely to suffer a recurrence of their cancer, researchers said.
    • “The score could help better manage the follow-up care for patients who’ve had pancreatic tumors surgically removed, and whose cancers have not spread to their lymph nodes, researchers wrote Dec. 17 in JAMA Surgery.
    • “We now have a way to identify patients whose higher risk of recurrence may have been previously overlooked,” senior researcher Dr. Cristina Ferrone, chair of surgery at Cedars-Sinai Medical Center in Los Angeles, said in a news release. “This gives us the opportunity to change the way we care for this patient population in a meaningful way.”
    • “The score helps people with pancreatic neuroendocrine tumors, which are a less common and typically less aggressive form of pancreatic cancer.
    • “Patients whose cancer has not spread outside the pancreas, to either the lymph nodes or surrounding organs, have a 91% five-year survival rate following surgery, researchers said in background notes.”
  • The Wall Street Journal relates
    • “For years, Barbara Schmidt’s family feared an illness was behind a pattern of terrifying falls that repeatedly landed the 83-year-old great-grandmother in surgery with broken bones. Instead, Schmidt’s frequent tumbles might have been tied to something else: medications intended to make her better.
    • “Schmidt, who lives with her husband of 65 years in Lewes, Del., filled prescriptions for more than a dozen different drugs in the past year, according to pharmacy and medical records.
    • “That isn’t unusual for America’s seniors, according to a Wall Street Journal analysis of Medicare data. One in six of the 46 million seniors enrolled in Medicare’s drug benefit, which pays for most drugs taken by older Americans, were prescribed eight or more medications.”
    • * * * “Schmidt’s recent prescriptions came from at least five different healthcare providers. Most were affiliated with the nearby hospital system Beebe Healthcare, including a nurse practitioner whom she sees for primary care and a gastroenterology office. An orthopedic surgeon who has treated her back problems and prescribed medications to help with her pain works for an independent practice, First State Orthopaedics. 
    • “A Beebe spokesman said it has reviewed its prescribing patterns and, this November, added a new electronic medical record that will allow doctors to “view consolidated medical and medication histories” for patients and deliver “safer, more informed care.” First State Orthopaedics said it doesn’t comment on matters of patient care unless it is legally required to do so.
    • “Pharmacists who work with seniors say doctors might not be aware of their patients’ full medication list. Patients don’t always mention what their other doctors have prescribed when a history is taken, and specialists might not have access to a shared medical record.
    • “The Journal analysis found that, among seniors taking eight or more drugs, it was common for the prescriptions to come from a large number of doctors.”

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

  • Per Beckers Hospital Review,
    • “Houston-based Nutex Health has opened its 26th micro-hospital, Archview ER & Hospital, in St. Louis.
    • “The 16,000-square-foot facility includes 15 emergency room beds, three inpatient suites, a full-service laboratory and advanced imaging technology, according to a Dec. 22 Nutex Health news release.
    • “It replaces Homer G. Phillips Memorial Hospital, which surrendered its license and closed in March. The hospital had been temporarily closed since December 2024, when its license was suspended due to a blood supply shortage.”
  • and
    • “Mark Cuban Cost Plus Drug Co. has added Vegzelma, a biosimilar indicated for six cancer types, to its marketplace for hospitals and other healthcare providers. 
    • “The company plans to expand its biosimilar offerings amid growing demand for biologics among health systems, according to a news release shared with Becker’s. Cost Plus Drugs also offers Starjemza, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), at a price about $3,000 lower than retail at other pharmacies.
    • “Vegzelma is a biosimilar to Roche’s Avastin (bevacizumab), which is approved for treatment of metastatic colorectal cancer; non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.”  

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Nine pharmaceutical companies including Bristol-Myers Squibb, GSK and Merckagreed to lower the prices that certain federal government programs and patients pay, in a new round of industry pacts with the Trump administration.
    • “The companies said they would reduce U.S. prices on drugs to levels comparable with prices charged in other wealthy countries, which are generally much lower. In return, the companies get administration-backed reprieves from potential new U.S. tariffs for three years.
    • “President Trump announced the deals Friday at the White House, joined by top executives of the nine companies. * * *
    • Under the terms, the “most-favored nation” prices offered by companies would apply to the U.S. Medicaid program for lower-income patients, direct-to-patient services including the planned TrumpRx.gov and to newly launched drugs in the future.
    • “Merck said it would make diabetes drugs Januvia and Janumet available to eligible American patients at a cash price that is 70% off the current list price through a direct-to-patient program. 
    • “Amgen said it would sell its migraine drug Aimovig for $299 a month, nearly 60% off the list price.
    • “Some of the companies in the new round of deals also agreed to donate the main ingredients for certain medicines to a national stockpile, to be available in the event of a national emergency. 
    • “GSK is donating six-months’ supply of a respiratory inhaler, and Bristol-Myers will donate six-months’ worth of the blood thinner Eliquis.
    • “Bristol-Myers said it would provide Eliquis free to Medicaid programs.”
  • The Hill adds,
    • “Medicare enrollees could save roughly half of what they usually pay for certain drugs next year, according to a study from the AARP.
    • “The study, published Thursday, found that the out-of-pocket cost of 10 drugs included in the first round of Medicare drug price negotiation will decrease substantially in five states with high enrollment in the program — California, Florida, New York, Pennsylvania and Texas — once negotiated prices go into effect on Jan. 1, 2026.” 
  • Roll Call sums up Congress’s activities in the final week of this term of Congress and looks forward to January.
    • “The Senate followed the House in leaving for the Christmas break on Thursday, clearing another batch of President Donald Trump’s nominations but kicking to January the fate of the next handful of spending bills.
    • “The Senate confirmed, 53-43, an en bloc package of 97 nominations. Senators also by unanimous consent confirmed the nomination of Kevin E. Lunday to be commandant of the Coast Guard. And they reached an agreement to set up confirmation of additional Trump nominees when they return in January.” * * *
    • “[T]he aspiration of Thune and Senate Republican appropriators to get the ball rolling on a package of fiscal 2026 spending bills was not to be. The rules require unanimous consent to combine more than one regular appropriations measure into a single bill — and that agreement proved elusive despite talks that went on throughout the day Thursday.
    • “That sets the stage for January, when lawmakers will have less than a month to figure out how to fund the government and avoid another partial government shutdown. Thune said he thought another shutdown would be “toxic” for Democrats and Republicans alike.
    • “I don’t think either side wants to see that happen,” Thune said. “So I’m hoping that there will be goodwill and we’ll figure out how to fund the government.”
  • Per a Centers for Medicare and Medicaid Service press release,
    • “The Centers for Medicare & Medicaid Services (CMS), in partnership with the Department of Labor and the Department of the Treasury (collectively, the Departments), today jointly proposed major updates to the historic health care price transparency rules established during President Trump’s first term.” * * *
    • “In line with Executive Order 14221, this proposed rule reflects the Department’s commitment to ensuring that health care pricing data is not only public but maximally impactful and actionable.
    • “Key improvements include:
      • “Requiring plans and issuers to exclude from the In-network Rate Files certain data for services providers would be unlikely to perform.
      • “Reorganizing In-network Rate Files by provider network rather than by plan, cutting redundancy, and aligning with how most hospitals report data pursuant to the Hospital Price Transparency requirements.
      • “Requiring Change-log and Utilization Files so users can easily identify what has changed from one In-network Rate File to the next and have clear information on which in-network providers are actively furnishing which items and services.
      • “Reducing reporting cadence for In-network Rate and Allowed Amount Files from monthly to quarterly, significantly reducing burden while maintaining meaningful transparency.
      • ‘Increasing the amount of out-of-network pricing information reported by reorganizing Allowed Amount files by health insurance market type, reducing the claims threshold to 11 or more claims, and increasing the reporting period from 90 days to 6 months and the lookback period of data from 180 days to 9 months. 
    • “The Departments seek feedback from stakeholders during the 60-day comment period on all elements of the proposed rule, including opportunities for further standardization and burden reduction. The deadline to submit comments is February 21, 2026.
    • “To access the proposed rule, visit: https://www.federalregister.gov/public-inspection/2025-23693/transparency-in-coverage
    • “To read the CMS fact sheet, visit: cms.gov/newsroom/fact-sheets/transparency-coverage-proposed-rule-cms-9882-p” 
  • Beckers Payer Issues informs us,
    • “CMS has proposed two new models aimed at curbing Medicare drug spending by linking payments to international benchmarks. The proposals — GUARD for Part D drugs and GLOBE for Part B — are the latest in the CMS Innovation Center’s efforts to make prescription drugs more affordable for beneficiaries while preserving the long-term sustainability of the Medicare program.” * * *
    • “The models were published via a notice of proposed rulemaking and are now open for public comment [for sixty days] through the Federal Register.” 
  • MedCity News delves into “CMS’ new ACCESS model [mentioned in yesterday’s post and], slated to begin on July 1, aims to shift traditional Medicare fee-for-service toward value-based care by tying payments to patient outcomes and encouraging tech-enabled, preventive care. Experts say it could benefit digitally mature, value-focused providers first, but its overall success will hinge on clear metrics, better data sharing and sustained participation.”
  • Per a Commitee for a Responsible Budget news release,
    • “Health care spending represents about 18% of the nation’s economy and the largest area of federal spending. High and rising health care costs are driven in part by the prices for medical care, which have risen 130% since 2000, compared to 93% for overall inflation.1 This is particularly true in commercial insurance – including large employers, the Affordable Care Act marketplaces, and public employers such as states and the federal government – where rising costs place a growing burden on workers, employers, and the federal government.2 To manage costs, many employers attempt to work with insurance plans to reduce spending, but many lack the market power to command lower prices from providers, such as hospitals.3
    • “Some public employers have looked to reference pricing to address rising employee health care costs in state plans. Under a reference pricing approach, the employer sponsoring the plan establishes a maximum price for certain services. States that have launched reference pricing programs for state employees have been able to reduce costs for state budgets, as well as for enrollees.
    • “In order to reduce health care costs more broadly, policymakers could consider adopting or encouraging reference pricing for federally subsidized insurance. A possible place to start would be the Federal Employees Health Benefits (FEHB) program, which is the largest employer-sponsored commercial insurance program in the country and costs the federal government roughly $50 billion per year.4
    • “In this brief, we discuss an option to adopt a version of reference pricing for hospital reimbursement rates in FEHB, with the reference price based on Medicare rates. Doing so could save billions of dollars for enrollees and the federal government.”
  • Tammy Flanagan, writing in Govexec, discusses “key decisions every federal employee [nearing retirement] must make. From survivor benefits and health coverage to leave payouts and TSP choices, federal employees nearing retirement face deadlines that can permanently shape their finances.”
  • The New York Times lets us know that “President Trump on Thursday ordered cannabis to be downgraded to a lower category of drugs, a change that would allow for more widespread use by patients and permit cannabis producers to take advantage of standard business tax breaks.” The article explains why “moving cannabis to a category of drugs that includes some common medicines will have implications for research, businesses and patients.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Seven years after the FDA’s accelerated approval of bleeding reversal agent Andexxa, which was then under the ownership of Portola Pharmaceuticals, the drug’s round trip on the U.S. market is coming to an end. 
    • “Andexxa, now under AstraZeneca’s stewardship, is slated to be pulled from the U.S. market next week, according to a Dec. 18 update from the FDA. 
    • “In the FDA communication, the agency notes that it has “received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.” Based on the available data, the agency “considers the risks of the product to outweigh its benefits,” it said.”
  • BioPharma Dive relates,
    • “The Food and Drug Administration has put a partial clinical hold on one of Merck & Co. and Daiichi Sankyo’s antibody-drug conjugates following an unexpected number of deaths in a late-stage clinical trial.
    • “Daiichi initiated a voluntary pause recruiting and enrolling the trial, called IDeate-Lung02, after “higher than anticipated incidence of grade 5 interstitial lung disease events,” a spokesperson for Merck and Daiichi said in a statement to BioPharma Dive. Following the pause, the FDA verbally placed the trial on a partial clinical hold in October. The spokesperson did not say the number of deaths recorded.
    • “During the hold, Daiichi, along with the FDA and an independent committee will review the safety data and “decide on any necessary further actions.” Trial enrollees will be able to continue treatment, but no new participants will be recruited.
    • “The experimental drug, called ifinatamab deruxtecan, or I-DXd, is one of three ADCs Merck gained the rights to through a major licensing deal with Daiichi in 2023. ADCs, which link an antibody to a toxic payload, are meant to more effectively target and destroy cancer cells while sparing the surrounding healthy tissue.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.
    • “The products are:
      • Enlicitide decanoate — an oral PCSK9 inhibitor for lowering LDL cholesterol
      • Sacituzumab Tirumotecan — a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate
    • “High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”
    • “With these awards,18 products have now received a voucher under the CNPV pilot program since it was established in June 2025. On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.”
  • and
    • “The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies. 
    • “The FDA recognizes that many breakthrough technologies and innovative solutions relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being developed by firms within venture capital portfolios. However, longstanding challenges, have limited engagement with innovative companies. Many existing federal contracting mechanisms favor large systems integrators and intermediaries that focus on labor-based work rather than scalable technologies. In addition, small business set-aside programs can be difficult for early-stage companies to access and have faced concerns about misuse.  
    • “We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is exploring a new approach that enables us to harness innovative capabilities and work directly with American entrepreneurs.”
  • Per Cardiovascular Business,
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for its Amplatzer Piccolo Delivery System. The device was developed for clinicians to use when implanting the company’s Amplatzer Piccolo Occluder in a premature baby with a patent ductus arteriosus (PDA).
    • “PDAs are holes between two blood vessels that typically close when a baby is born. In rare instances, however, the hole stays open after birth, directing too much blood toward the lungs and impacting the neonate’s ability to breathe.
    • “The Amplatzer Piccolo Occluder first secured FDA approval and CE mark approval in 2019. It is the first transcatheter treatment to gain FDA clearance for closing a PDA in a premature infant. The device is smaller than a pea and delivered through a tiny incision in the child’s leg before it is guided to the heart using the newly cleared Amplatzer Piccolo Delivery System.
    • “We designed the Amplatzer Piccolo Delivery System based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier,” Sandra Lesenfants, senior vice president of Abbott’s structural heart business, said in a prepared statement. “With the Amplatzer Piccolo Occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”

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 across 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.
  • Beckers Clinical Leadership tells us,
    • “Flu hospitalization cases are evenly split between children and older adults, Northwell said, and its Cohen Children’s Medical Center in New York City is at capacity. 
    • “Flu is rising a lot faster than it did last year,” Dwayne Breining, MD, senior vice president of lab services at Northwell, said during a Dec. 18 news conference. 
    • “The other two [COVID-19 and RSV] are rising but not as fast as they did last year,” Dr. Breining said. “That’s driven by a couple of things. What’s very concerning for us is the cases of flu are rising at like 35% per week; the hospitalizations are rising at 75% per week. So we’re keeping a close eye on that trend. It could mean the flu is more severe.”
    • “Experts have said a mutated version of H3N2, “subclade K,” could be fueling the current uptick in flu activity amid earlier and more intense outbreaks abroad. The strain is a version of the influenza A virus, which is generally known to cause more severe illness, particularly in older adults and young children.
    • “At Northwell, more than one-third of flu tests for the week ending Dec. 14 were positive for influenza A’s H3 subtype. The same week period in 2024 saw a 10% flu positivity rate.”
  • Per a National Institutes of Health news release from its Director Dr. Jay Bhattacharya,
    • “At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities. Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.
    • “To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report).  Deliberations were informed by a team of multi-disciplinary experts and community conversations across the country, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.
    • “I am pleased to endorse these recommendations, which focus on:
      • “providing a clear vision and framework for maximally involving patients and communities in clinical research;
      • “ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and
      • “increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.
    • “NIH is eager to begin implementing this roadmap, starting in 2026.”
  • The University of Minnesota’s CIDRAP adds,
    • Today [December 17] the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and NEJM Evidencelaunched their new Public Health Alerts initiative with reports on potential local transmission of clade 1b mpox virus (MPXV) in California and on influenza viruses circulating during the 2024-25 flu season.
    • Public Health Alerts is designed to deliver information and early warnings about emerging health threats, enabling swift, informed responses across the United States and globally.
    • “The new collaboration between NEJM Evidence and CIDRAP fills a gap in reliable data, offering expert-reviewed reports that translate frontline observations into actionable public health evidence. An NEJM Evidence editorial today explains the initiative further.
    • “Access to emerging public health data saves lives,” said infectious disease doctor Eric J. Rubin, MD, Editor-in-Chief of the New England Journal of Medicine and NEJM Group, publisher of NEJM Evidence, in a news release. “By providing this new, rigorous pathway for public health information, NEJM Group is delivering on its commitment to equip physicians with reliable information to support evidence-based care.”
    • “Rapid, credible communication has always been essential to an effective public health response,” added CIDRAP Director Michael Osterholm, PhD, MPH. “With this new collaboration, we hope to restore and strengthen that early-warning function, providing timely, evidence-based alerts that can help local and state health leaders act quickly to protect the health of people in their communities.” 
  • Health Day informs us,
    • “It’s beside the point to debate whether vaping or nicotine pouches can be more healthy than smoking a cigarette, a major new report argues.
    • “Nicotine is toxic to the heart and blood vessels regardless of how it’s consumed, according to an expert consensus report published today in the European Heart Journal.
    • “Nicotine is not a harmless stimulant; it is a direct cardiovascular toxin,” said lead researcher Dr. Thomas Münzel, a senior professor of cardiology at University Medical Center at Johannes Gutenberg University in Mainz, Germany.
    • “Across cigarettes, vapes, heated tobacco and nicotine pouches, we consistently see increased blood pressure, damage to blood vessels and a higher risk of heart disease,” Münzel said in a news release. “No product that delivers nicotine is safe for the heart.”
  • and
    • “Young adults are inheriting a world filled with turmoil and unrest, and this instability is leaving its mark on their mental and emotional health.
    • “A single half-hour course, however, could help them feel less anxious and depressed, by helping them increase their tolerance of uncertainty, a new study says.
    • “Young adults who took the course titled “Uncertainty-Mindset Training” continued to feel better a month after taking it, researchers reported Dec. 15 in the journal Psychological Medicine.
    • “Young people today are coming of age amid great climate, economic, social and health uncertainty,” senior researcher Susanne Schweizer, an associate professor with the University of New South Wales in Sydney, said in a news release.”
  • The Washington Post points out that “feeling wonder every day improves our health and explains how to do it.
  • Health Day calls attention to
    • “A new rapid test [that] could improve treatment of urinary tract infections (UTIs), by identifying the most effective antibiotic for each individual patient.
    • “The test applies different antibiotics to bacteria found in urine samples, to see which one best suppresses bacterial growth, researchers recently reported in the journal Microbiology Spectrum.
    • “This new method could cut a full day off the time between testing and prescription, researchers said, and arm a patient with the best means of clearing their infection.
    • “The sooner we know which antibiotic is effective, the more targeted our treatment can be,” senior researcher Oliver Hayden, a professor of biomedical electronics at the Technical University of Munich in Germany, said in a news release.”
  • Beckers Hospital Review lets us know about GLP-1 drugs that are poised to enter the U.S. market.
  • Per BioPharma Dive,
    • “An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
    • “The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
    • “Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.”
  • Per the Genetic Engineering and Biotechnology News,
    • “As the number of antibiotic-resistant infections continues to rise, scientists are looking to bacteriophages (“phages”), viruses that infect bacteria, as an approach to tackling antibiotic resistance. A new study by researchers at the Hebrew University of Jerusalem has revealed how bacteriophages use a tiny piece of genetic material to hijack bacterial cells and make more copies of themselves.
    • “Focusing on infection of Escherichia coli by phage lambda, a bacteriophage that scientists have been studying for decades, research lead Sahar Melamed, PhD, and colleagues identified a virus-encoded small RNA molecule (sRNA) called phage replication enhancer sRNA (PreS) that acts like a hidden genetic “switch.” The team’s research indicated that this switch rewires bacterial genes to help the virus copy its DNA more efficiently and boost viral replication.
    • “The team said that understanding how phages control bacterial cells is important both for basic science and to help inform future medical applications. By uncovering how phages use tools such as PreS to take control of bacterial cells, the newly reported study provides important basic knowledge that could help scientists design new phage-based therapies targeting drug-resistant bacteria.”

From the U.S. healthcare business front,

  • Kaufman Hall discusses “key health system enterprise strategy trends in 2025… and our predictions for 2026.”
  • Radiology Business reports,
    • “Commercial insurer Anthem is defending a controversial new plan to penalize hospitals who use out-of-network radiologists and other physicians. 
    • “Word of the new administrative policy first surfaced in October and is slated to take effect Jan. 1 across 11 states. Anthem plans to punish hospitals by charging a 10% penalty of the allowed amount for claims that involve docs outside of its networks. 
    • Radiologists and other physicians have roundly criticized the change, labeling the policy as “deeply flawed and operationally unworkable.” The American Hospital Association also joined the chorus on Wednesday with its own sternly worded letter, calling for Anthem parent Elevance Health to rescind the policy. 
    • “However, the Indianapolis-headquartered conglomerate is standing its ground and refusing to honor such requests. Radiologists have charged that the No Surprises Act and its independent dispute resolution process already addresses concerns raised by Elevance. 
    • “We agree that the federal NSA has fulfilled its intent of protecting patients from unexpected medical bills at the point of care,” Catherine Gaffigan, MD, president of health solutions for Elevance Health, detailed in a Dec. 9 response letter to the American Medical Association and others who wrote to the company in November. “At the same time, our experience shows it has also created incentives for many care providers to remain out-of-network due to extremely high, unsustainable IDR awards—on average around nine times in-network commercial reimbursement rates—resulting from the NSA’s IDR arbitration process.” 
  • Amen to that.
  • Fierce Pharma relates,
    • “Pharma marketers enter 2026 asking where DTC fits in the DTP era. 
    • “That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient (DTP) programs. In the last few months alone, Amgen, Bristol Myers Squibb, AstraZeneca, Genentech, Novartis and Boehringer Ingelheim have all launched DTP services with discounts for self-pay patients on certain popular medications, joining earlier adopters Eli Lilly, Pfizer and Novo Nordisk.
    • “The programs are changing how patients access medicines—and how patients hear about medicines could therefore evolve to reflect the emerging sales channel.” 
  • and
    • “Sixteen months after luring former Roche dealmaker James Sabry, M.D., Ph.D., out of retirement and signaling a shift in its business development approach, BioMarin has announced the largest transaction in the company’s 28-year history.
    • “In a merger of rare disease specialists, BioMarin has agreed to acquire Amicus Therapeutics for $4.8 billion. The California biopharma will pay $14.50 per share, which is a 33% premium on the $10.89 Thursday closing price of the New Jersey-based biopharma and a 46% premium on its 30-day average.
    • “With the deal, BioMarin gains two rapidly growing products—Fabry disease drug Galafold and Pompe disease combination treatment Pombiliti-Opfolda. BioMarin also acquires the U.S. rights to DMX-200, a potential first-in-class small molecule in phase 3 development for the rare kidney disease focal segmental glomerulosclerosis (FSGS).”
  • and
    • “Regeneron has had its hands full this year contending with regulatory setbacks, Amgen’s marketed Eylea biosimilar and Roche’s hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar competition to the New York drugmaker’s blockbuster eye drug Eylea is only likely to ratchet up.
    • “Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product “in the fourth quarter of 2026, or earlier under certain circumstances,” according to a Dec. 19 press release from Alvotech.”

Thursday report

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

From Washington, DC,

  • The Society for Human Resource Management tells us,
    • “In an address to the nation on Dec. 17, President Donald Trump spoke about the economy, efforts to lower prescription drug prices, and his plans for the year ahead. He noted the pending launch of a new website, TrumpRx.gov, in January 2026, highlighted economic progress, and announced a bonus payment of $1,776 to every military service member as a “Warrior Dividend.” He also touted his economic record and predicted the country is “poised for an economic boom the likes of which we’ve never seen.”
  • STAT News adds,
    • When HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year, it pointed them to an alternative way to get the treatments: Buy them themselves.
    • In a notice viewed by STAT, HCA said use of the GLP-1 weight loss drugs surged 90% this year, “significantly” raising costs. It instead suggested employees enroll in discount programs introduced by the drugs’ manufacturers, Eli Lilly and Novo Nordisk, which allow patients to buy the medicines without using insurance at cash prices that are lower than the list prices.
  • The Wall Street Journal reports,
    • “Millions of Americans are facing higher healthcare premiums and lingering uncertainty about whether help might still arrive, with Congress set to break for the rest of the year without renewing enhanced Affordable Care Act subsidies. 
    • “Supporters of the subsidies insist the fight isn’t over. But prospects of a bipartisan deal remain slim, even as some lawmakers and people close to the Trump administration signaled that voter pressure could lead to a retroactive fix when Congress reconvenes in the new year.
    • “I’m not ruling anything out,” Senate Majority Leader John Thune (R., S.D.) told reporters Thursday.”  
  • Modern Healthcare adds,
    • “Health insurance exchange shoppers facing huge premium hikes are scrambling for deals during this sign-up season.
    • “Insurance brokers report high interest in bottom-tier, lower-cost Bronze plans, policies only available outside the exchanges and alternatives such as short-term plans. Some of those consumers are downgrading from Silver or higher amid skyrocketing prices tied to the expiration of enhanced subsidies at the end of the year.
    • “Yet enrollment in Affordable Care Act of 2010 plans was outpacing last year as of Dec. 5, when sign-ups reached 5.8 million, a 7% increase from the same period in 2024, the Centers for Medicare and Medicaid Services reported. Notably, 950,000 enrollees were new to the exchanges. Open enrollment began Nov. 1 and runs until Jan. 15 in most states, although Monday was the last day to choose a plan that would be in place on Jan. 1.
    • ​“All of the attention that has been paid to the market has actually helped enrollment,” said Wesley Sanders, founder and principal consultant at the health insurance consulting firm Evensun Health.” 
  • Govexec informs us,
    • “President Trump on Thursday issued an executive order implementing his plan to provide civilian federal workers with a 1% across-the-board pay raise next month.
    • “As first proposed in August, the increase is entirely being applied to buttress federal workers’ basic pay, with no changes to locality pay rates coming next year. Though the White House skipped outlining its pay raise plans as part of its annual budget proposal, officials initially planned on issuing a pay freeze for 2026. * * *
    • “The administration published pay tables outlining the 2025 pay raise across the General Schedule, along with tables for VA health workers, senior executives, and military service members on the White House website.”
    • [The executive order further states “Additionally, the Director of the Office of Personnel Management (Director) is directed to assess whether to provide up to a total increase of 3.8 percent (inclusive of the increase provided under Section 1) to the rates of pay of certain Federal civilian law enforcement personnel, as determined by the Director following coordination with agencies and consistent with 5 U.S.C. 5305.”}
  • and
    • “President Donald Trump in an executive order on Thursday gave the federal workforce a holiday on Dec. 24 and 26. Because Christmas falls on a Thursday this year, this provides government workers with a five-day weekend. 
    • “According to the directive, agency heads can require certain offices to remain open on either day due to national security, defense or other public need.” 
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services announced Dec. 18 that it will launch a voluntary payment model designed to broadly reach more health care providers who have not joined accountable care organizations, including those with specialized patient populations and others such as small, independent or rural-based practices. The Long-term Enhanced ACO Design Model will begin Jan. 1, 2027, and continue for 10 years. CMS said ACOs can apply for participation in March following the release of a request for applications.”
  • and
    • “The Department of Health and Human Services Dec. 18 announced three regulatory actions related to the practice of “sex-rejecting procedures” on children.
    • “The Centers for Medicare & Medicaid Services issued a proposed rule that would prohibit hospitals participating in the Medicare and Medicaid programs from performing SRPs on individuals under 18 years of age. The proposed condition of participation defines SRPs as “any pharmaceutical or surgical intervention that attempts to align an individual’s physical appearance or body with an asserted identity that differs from the individual’s sex …” and would include procedures that would intentionally disrupt, suppress or alter the development of an individual’s biological functions, physical appearance or body. The proposed rule provides exceptions for the treatment of an individual with a verifiable disorder of sexual development, for uses other than attempting to align an individual’s physical appearance or body with an identity other than the individual’s sex, or to treat complications arising from, or exacerbated by, previous performance of an SRP. The proposed rule did not specify how the proposed prohibitions would be enforced.
    • “Separately, CMS published a proposed rule that would prohibit states from receiving federal matching funds for SRPs provided to Medicaid and separate Children’s Health Insurance Program beneficiaries under the age of 19. CMS notes that these proposed changes would not prevent states from providing coverage for SRPs with state-only funds. The exceptions outlined in the COP proposed rule are also applied to the Medicaid/CHIP rule.
    • “Comments on the proposed rules are due Feb. 16.
    • “HHS’ Office for Civil Rights also proposed to revise its regulations implementing Section 504 of the Rehabilitation Act of 1973 to clarify that the definitions of “disability” and “individual with a disability” exclude “gender dysphoria” not resulting from physical impairments. Comments on HHS OCR’s rule are due Jan. 20.”
  • Per Healthcare Dive,
    • “The Federation of American Hospitals has tapped Charlene MacDonald as its next CEO, the for-profit hospital association said Tuesday.
    • “MacDonald is succeeding Chip Kahn, who announced his retirement earlier this year. Kahn is stepping down after almost 25 years at the helm of the FAH.
    • “MacDonald previously led the FAH’s lobbying, public affairs and communications efforts, and oversaw its finance and operations teams. She’ll start as CEO on Jan. 1.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “Eli Lilly’s experimental obesity pill orforglipron helped people maintain their weight following a 72-week course of the GLP-1 shots Zepbound or Wegovy in a Phase 3 clinical trial, opening up a potential new use for drugs of its kind.
    • “People taking orforglipron after Wegovy gained less than one kilogram over the span of a year, while those who got Zepbound regained five kilograms. Both ended up at the same average at the end of the study period, however, and placebo recipients regained more than nine kilograms before being offered “rescue” orforglipron.
    • ‘Lilly also said it has officially asked the Food and Drug Administration to approve orforglipron. The pill was awarded one of the FDA’s new “national priority” vouchers, making a decision likely within weeks rather than the standard six to 10 months.”
  • Fierce Pharma reports,
    • “A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.
    • “Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
    • “Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.
    • “This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.”
  • MedTech Dive points out,
    • “Pulse Biosciences said Thursday it got the Food and Drug Administration’s go-ahead to begin an investigational device exemption study of its cardiac catheter ablation system to treat drug-resistant paroxysmal, or intermittent, atrial fibrillation.
    • “The company has developed technology that delivers nanosecond electrical pulses to treat the heart rhythm condition. Nanosecond pulses are briefer in duration than the microsecond pulses used in other pulsed field ablation systems, which could offer advantages. The Pulse Biosciences catheter is designed to deliver a complete lesion in a single energy application.
    • “Pulse Biosciences will evaluate the safety and effectiveness of its nPulse ablation catheter in the single-arm, multicenter NANOPULSE-AF study.:
  • and
    • “CMR Surgical said Tuesday it received 510(k) clearance from the Food and Drug Administration for its next-generation robotic system to perform gallbladder removal procedures.
    • “The Cambridge, England-based company said more than 40,000 surgical procedures have been completed with its robotic platforms outside of the U.S., across multiple specialties and care settings.
    • “CMR said it is on track to begin launching the new system, called Versius Plus, in the U.S. in 2026.”

From the judicial front,

  • ABC News reports,
    • “The evidence suppression hearing in the case against accused CEO killer Luigi Mangione concluded Thursday after the defense signaled it would call no witnesses.
    • “The defense rests,” defense attorney Karen Agnifilo said after prosecutors indicated they, too, rested.
    • “The nine-day hearing will determine what evidence will be used against Mangione when he goes on trial on charges of gunning down UnitedHealthcare CEO Brian Thompson on a Manhattan sidewalk last year.
    • “New York Judge Gregory Carro gave the defense until Jan. 29 to make its final argument about the evidence in writing.  Prosecutors have until March 5.  The defense then has two weeks after that to submit a reply.
    • “Carro said he expected to issue his decision about what, if any, evidence to exclude on May 18, at which point he would also set a date for trial.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The Los Angeles wildfires of nearly a year ago took an unexpectedly heavy toll on residents’ health, a new study found. 
    • “An unusually large number of people suffered from heart attacks, lung conditions and a perplexing rise in unexplained illnesses, according to an analysis by researchers of emergency-department data at Cedars-Sinai, the largest hospital in Los Angeles County. 
    • “Their findings offer clues into the potential cost to human health of massive wildfires that spread quickly from wild lands into urban areas, said Dr. Susan Cheng, vice chair for research affairs at Cedars-Sinai’s Smidt Heart Institute and senior author of the study.
    • “Such wildfires are increasing in frequency and scope, and release heavy metals and other toxins into the air as they engulf homes and cars. 
    • “You have a much greater magnitude and a much greater complexity of toxins being produced by the disaster affecting a very large, large population of people,” she said.” 
  • NBC News relates,
    • “As of Dec. 6, the Centers for Disease Control and Prevention had logged 26,632 cases of whooping cough in 2025. The last time the U.S. saw so many cases was more than a decade ago, in 2014, according to CDC data.
    • “But an NBC News/Stanford University investigation has found that DTaP vaccination rates are plummeting across the country, as part of a larger, troubling trend of growing vaccine hesitancy that is fueling a resurgence of preventable diseases, including measles.”
  • Managed Healthcare Executive adds,
    • “While most (82%) primary care physicians (PCPs) in the United States understand the risk factors for shingles, far fewer (29%) are fully aware of current shingles vaccine recommendations, according to a recent study published in Human Vaccines and Immunotherapeutics. The study was sponsored by GSK, the manufacturer of the recombinant zoster vaccine (RZV).”
  • BioPharma Dive notes,
    • “An experimental drug Takeda acquired in a multibillion-dollar deal has succeeded in a pair of late-stage trials, positioning the company to seek clearance of a therapy it expects to become a future blockbuster.
    • “The therapy, known as zasocitinib, met its co-primary and top secondary objectives in two Phase 3 studies testing it against a placebo or Amgen’s Otezla in patients with plaque psoriasis. Without disclosing specifics, Takeda said Thursday that, after four months, zasocitinib demonstrated “superiority” on both top study goals, which involved meaningfully reducing disease severity on two different measures. Respiratory tract infections, colds and acne were the most common side effects, according to the company.
    • “Takeda will provide detailed results at an upcoming medical meeting and intends to file for approvals in the U.S. and elsewhere during its 2026 fiscal year. Zasocitinib is also being evaluated in multiple other indications, as well as in a head-to-head study testing it against Bristol Myers Squibb’s similar, rival drug Sotyktu.”
  • and
    • “A streak of positive news that pushed Insmed into the ranks of the most valuable biotechnology companies ended this week with the announcement of a failed clinical trial.
    • “The company’s share price dropped almost 17% to about $165 early Thursday, following the announcement late Wednesday. The stock, which was worth around $25 a year and a half ago, had vaulted above $200 in trading this week.
    • “The Phase 2b study focused on a drug called brensocatib, which Insmed already sells under the brand name Brinsupri to treat a lung disease known as non-cystic fibrosis bronchiectasis. The company had hoped to expand use of the medicine to include a chronic nasal condition, but researchers found no benefit for either of the two doses they tested.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “All community pharmacies in Optum Rx’s network have transitioned over to a cost-based reimbursement model as the massive pharmacy benefit manager tries to reduce variation in how pharmacies are paid.
    • “Optum Rx first launched the model across roughly 1,400 community pharmacies in March. Now, the PBM, which is owned by healthcare conglomerate UnitedHealth, has notched agreements with three additional pharmacy services administration organizations representing more than 17,000 community pharmacies to transition them to cost-based contracts, Optum Rx said Thursday.
    • “Optum Rx aims to move all of its pharmacy partners to the new model, which should result in pharmacies being paid more for brand-name drugs and less for generics, by January 2028. The PBM is still working on those owned by retail chains and grocers, a network contracting executive said.”
  • Beckers Payer Issues tells us,
    • “UnitedHealthcare is delaying a coverage policy that would have sharply restricted remote physiologic monitoring services for most chronic conditions.
    • “The policy, which had been scheduled to take effect Jan. 1, will now be implemented later next year, the insurer confirmed to Becker’s.
    • “After listening to feedback from care providers, medical societies and other stakeholders, we are postponing the Remote Physiologic Monitoring (RPM) policy scheduled to take effect on Jan. 1, 2026. We still intend to implement this policy in 2026 and will share an updated timeline once it is finalized,” a UnitedHealthcare spokesperson said.”
  • BioPharma Dive notes,
    • “Moderna said Thursday its experimental bird flu vaccine, which was cut from federal funding earlier this year, will receive up to $54.3 million from a global coalition to advance the candidate.
    • “The Coalition for Epidemic Preparedness Innovations, or CEPI, a public-private global partnership working to develop vaccines against pandemics, agreed to fund Moderna’s candidate mRNA-1018 against H5 avian influenza into Phase 3 testing. As part of the agreement, if the shot is approved and in the event of an influenza pandemic, Moderna will allocate 20% of its production capacity for low- and middle-income countries, “at affordable pricing.”
    • “Under the Biden administration, the experimental vaccine was awarded over $700 million in government contracts from the Biomedical Advanced Research and Development Authority, or BARDA. Those contracts were later canceled by the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., a major critic of messenger RNA technology.”
  • MedTech Dive relates,
    • “Editor’s note: This is the fourth article in a series of stories profiling medtech companies that are changing the field of robotic surgery. You can read the first three stories here, here and here.
    • “XCath is developing a robot-assisted approach to brain aneurysm treatment that could bring greater precision to procedures and enable more physicians to perform them.
    • “A cerebral aneurysm is a bulge in a weakened area of an artery in the brain. To prevent a life-threatening rupture of the vessel wall, endovascular interventions that access the aneurysm from inside the artery are increasingly preferred over traditional open surgery.
    • “While less invasive than open surgical repair, the intricate procedures are not free from complications and require significant technical skills to perform. A global shortage of neurointerventionists with expertise to perform the procedures has raised concerns about limited patient accessto critical stroke care.
    • “XCath, a Houston-based startup, is working on a robotic system that it expects to standardize endovascular brain aneurysm treatment. The goal is to facilitate consistent performance among a wider field of physicians, minimize complications and improve clinical outcomes.”

Midweek update

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate approved a sweeping defense-policy package despite alarm over a provision that rolls back safety measures put in place following the fatal midair collision in January between a military helicopter and passenger plane at Ronald Reagan Washington National Airport. 
    • “The Senate passed the $901 billion National Defense Authorization Act on a vote of 77-20, codifying more than a dozen of President Trump’s executive orders, while placing new limits on his ability to act unilaterally overseas. The House passed the annual measure last week 312 to 112, and it now goes to Trump’s desk for his signature.
    • “While the bill sets specific spending levels for the Pentagon, it doesn’t appropriate any money, which is done through separate legislation. Lawmakers added $8 billion to the Pentagon’s budget request. The legislation would increase America’s total national-security budget by less than 1% from last year’s $895 billion authorization bill. It also raises troop pay 3.8%.”
  • Fierce Healthcare adds,
    • “Nearly two years after its introduction as a bill during the last U.S. Congress, the Biosecure Act has survived an election and a presidential transition and appears poised to become law. But this version, tucked into the nation’s annual defense bill, features some changes from the first iteration.
    • “Both the House of Representatives and the Senate have passed the $901 billion defense bill, sending it to the president’s desk for a signature. The White House has said President Donald Trump plans to sign the massive defense package, Reuters reports.
    • “Within the mammoth bill, the Biosecure Act has the potential to raise new hurdles for certain life sciences companies from China, as well as their partners, although the exact effects of the legislation remain tough to fully assess at this stage.”
  • STAT News tells us,
    • “House Republicans on Wednesday passed a health care bill aimed at lowering health care costs and providing more options for employer-provided health insurance.” * * *
    • “The Lower Health Care Premiums for All Americans Act would expand access to association health plans by allowing small employers and self-employed individuals to band together across industries to buy insurance that is less regulated. Large employers already can offer this kind of coverage. About 700,000 more people per year on average would choose association health plans under the bill, about 200,000 of whom currently don’t have insurance, according to the nonpartisan Congressional Budget Office.” * * *
    • “Another measure would prevent states from regulating stop-loss insurance that self-insured plans use to protect against large claims to control costs. 
    • “It also would fund cost-sharing reductions for low-income enrollees in the Affordable Care Act marketplace. Funding cost-sharing reductions would lower gross premiums for benchmark silver plans by 11% on average, according to the CBO. Because ACA subsidies are based on the cost of a silver plan, that lowers the amount of tax credits available to buy any plan.” 
  • The Wall Street Journal further reports,
    • “Four vulnerable House Republicans rebelled against Speaker Mike Johnson (R., La.) and backed a Democratic effort to force a vote on extending Affordable Care Act subsidies, exposing GOP fractures over surging healthcare costs headed into next year’s midterm elections.” * * *
    • “With the GOP signatures on the discharge petition, Jeffries now has the 218 needed to force a vote, which wouldn’t likely occur until after the holiday break. But the centrists’ move could keep up pressure on both parties to reach a deal, and talks were continuing in the Senate on a possible compromise for early in the new year.
    • “The defections delivered a blow to Johnson’s leadership in the House, where he has been forced to manage a historically narrow majority—currently 220-213—that gives any small bloc of Republicans power to derail or hijack his agenda.
    • “We’re keeping a productive conversation going,” Johnson told reporters after the defectors signed onto the Democratic plan. “I have not lost control of the House.”
  • STAT News tells us,
    • “Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, according to four people familiar with the plans, who were not authorized to speak publicly.
    • “The agreements would be the latest in a series of deals in which pharmaceutical companies agree to lower drug prices and invest more domestically in exchange for avoiding tariffs and other benefits, such as fast-tracked drug reviews.”
  • An OPM Inspector General data brief lets us know that following an OPM mandate in January 2023, spending on GLP-1 drugs in the FEHB Program for the treatment of obesity surged dramatically. While OPM has the authority to make unilateral amendments to their FEHB and PSHB contracts with carriers, the carriers have a right to an equitable price adjustment. See Section 5.38 of the standard OPM contracts. The only way to achieve is an equitable price adjustment (or any price adjustment for that matter) is through the annual benefit and rate proposal process. OPM should have proposed the change for 2024, and then allowd the carriers to include the cost of these drugs in their 2024 premium. OPM didn’t do this. and this mistake caused FEHB premiums to jump more than they should have in 2025. This should be the lesson taken from this data brief.
  • Govexec informs us,
    • “The U.S. Postal Service on Wednesday announced plans to expand access to its last-mile delivery network, which the new postmaster general hopes will provide a boon to the financially struggling agency. 
    • “In the logistics business, the most expensive part of delivery is generally the ‘last mile’ portion of a route. As part of our universal service obligation, we deliver to more than 170 million addresses at least six days a week, so we are the natural leader in last-mile delivery,” Steiner said in a statement. “We want to make this valuable service available to a wide range of customers that see the worth of last mile access — other logistics companies and retailers large and small.” 
    • “USPS in late January or early February 2026 will begin auctioning off access to more than 18,000 delivery destinations, according to a press release. 
    • “Steiner said in an interview with Reuters about the program that it could raise billions in revenue for USPS, which is needed as the PG also warned that the agency could run out of money in early 2027.”
  • Federal News Network interviews NARFE’s Staff Vice President for Policy and Programs John Hatton.
    • Federal employees are seeing signs of stability. Retirement processing is improving, workforce protections are holding, and pay raise prospects are clearer. But with continuing resolutions and hiring freezes still in the mix, the path forward requires careful planning. What can be expected in the coming year?
  • Mercer informs us,
    • “Starting next July, employers can voluntarily contribute to the Trump accounts of employees’ dependent children. Created by the One Big Beautiful Bill Act (Pub. L. No. 119-21), these accounts are a new kind of tax-preferred savings vehicle for individuals under 18. Employer contributions up to $2,500 per year are excludable from an employee’s gross income if made pursuant to a program that meets certain conditions. This tax exclusion also applies to employer contributions to accounts of employees who are under 18. Originally published on Aug. 5, 2025, this article has been updated to reflect IRS guidance in Notice 2025-68. IRS intends to propose regulations consistent with the guidance in the notice. IRS is accepting comments on the notice through Feb. 20, 2026.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With a fresh endorsement from the FDA, the last of five major drug approvals has fallen into place for GSK in 2025.
    • “Tuesday, the U.S. regulator greenlit GSK’s depemokimab, an ultra-long-acting biologic, as a new add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients ages 12 and older. The drug will hit the market under the Exdensur brand name, GSK said in a Dec. 16 press release.
    • “GSK has drafted lofty sales ambitions for Exdensur, an IL-5 antagonist that is injected just twice a year. The British pharma has previously estimated the inflammatory disease med could reel in sales of 3 billion pounds sterling ($4 billion) at peak.”
  • BioPharma Dive informs us,
    • “DBV Technologies shares soared Wednesday after the company said its Viaskin peanut allergy patch succeeded in a Phase 3 trial.
    • “The results represent a comeback for the patch, which was rejected by the Food and Drug Administration in August 2020. At the time, regulators said the patch needed modifications to fully adhere to the skin and called for more data to support its efficacy.
    • “With the results of the trial, dubbed Vitesse, in hand, DBV now plans to submit an application to the FDA in the first half of next year to clear the patch for children between the ages of 4 and 7. The FDA has previously awarded the treatment a breakthrough therapy designation, and it may qualify for a priority review, DBV said Tuesday.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) said the United States has tracked 1,958 measles cases so far this year, nearing the 2,000-case milestone just one month before the country will likely lose its elimination status. 
    • “The total represents 46 new US cases.
    • “There have been 49 US outbreaks reported in 44 US jurisdictions, the CDC said, as well as 24 measles cases reported among international visitors to the United States. Eighty-eight percent of all measles cases reported this year have been outbreak-associated. 
    • “Among US cases, 26% are in children under the age of 5 years, 41% of patients are between 5 and 19 years, 32% are 20 years or older, and 1% have unknown ages. Ninety-three percent of case-patients are unvaccinated or have unknown vaccination status, while 3% have one dose of measles-containing vaccine, and 4% are fully vaccinated. 
    • “So far, 222 people (11%) have been hospitalized for measles infections in the United States this year, and three have died.”
  • and
    • “Two studies on respiratory syncytial virus (RSV) protection conclude that vaccine effectiveness against infection and related health care use drops over 18 months in US veterans and that the effectiveness of the long-acting monoclonal antibody preventive nirsevimab is strong in hospitalized European children younger than two years but wanes over seven months.
    • “Older adults and infants are especially vulnerable to severe RSV, with possible complications of bronchiolitis, pneumonia, and sepsis.” * * *
    • “In an editorial in the same journal, Editorial Fellow Anna Hung, PhD, of Duke University, and Associate Editor Lona Mody, MD, of the University of Michigan, noted that, despite the Centers for Disease Control and Prevention’s recommendation for a single dose for anyone aged 75 and older and those aged 60 to 74 years at increased risk for severe disease, less than half of either group receives the vaccine.
    • “This low uptake can be explained by various reasons including relative recency of development of the vaccine, lack of awareness of the seriousness and frequency of RSV infection, a hazy shared clinical decision-making model, access barriers, a general vaccine fatigue, and lack of clear guidance to clinicians,” they wrote. 
    • “They added that the greater decline in VE among immunocompromised veterans suggests the need for RSV boosters. “Experts will need to evaluate this evidence carefully to update guidance,” they wrote.”
  • The American Hospital Association News lets us know, “Depression and anxiety can increase the risk of a major adverse cardiac event, according to an American Heart Association study published Dec. 17.”
  • Health Day relates,
    • “Adherence to cervical cancer screening guidelines is low, with more than 60 percent undergoing overscreening, according to a research letter published online Dec. 10 in JAMA Network Open.
    • “Michelle B. Shin, Ph.D., M.P.H., R.N., from the University of Washington in Seattle, and colleagues examined cervical cancer screening guideline adherence among a nationally representative commercially insured cohort to assess factors and modalities associated with nonadherence. Data were analyzed from the 2013 to 2021 Optum Clinformatics anonymized longitudinal claims database covering about 13 million individuals annually.
    • “The researchers found that among 670,003 eligible individuals, 47.1 and 52.9 percent received cytology alone and cotesting, respectively. Overall, only 7.3 percent were guideline-adherent, while 61.6 and 31.1 percent were overscreened and underscreened, respectively.”
    • * * * “Consistent with prior work, we observed low adherence (7.3 percent) to cervical cancer screening guidelines among the commercially insured U.S. population despite stable coverage, likely reflecting guideline confusion among patients, clinicians, and health systems,” the authors write.”
       
  • Per the University of Minnesota’s CIDRAP,
    • “Treatment with the antiviral combination nirmatrelvir–ritonavir (Paxlovid) was associated with fewer lost workdays and lower disability-related costs among US employees at high risk for severe COVID-19, according to a retrospective observational study in the Journal of Medical Economics.
    • “Using insurance claims and workplace productivity data from large US employers, the researchers, led by scientists from Paxlovid maker Pfizer, compared productivity outcomes among high-risk employees diagnosed as having COVID who either received Paxlovid within five days of diagnosis or received no antiviral. 
    • “Analyses of absences among treated and untreated workers and those on short-term disability (STD) and long-term disability (LTD) included 1,909, 20,065, and 20,318 employees, respectively. The study included data from December 2021 through December 2022, a period dominated by Omicron variants.”
  • Per Fierce Pharma,
    • “The combination of Keytruda and Padcev is taking another major step toward securing its position as a leading therapy in the treatment of bladder cancer.
    • “The PD-1/antibody-drug conjugate pairing significantly extended the lives of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy compared with chemotherapy, according to results from the phase 3 Keynote-B15 (EV-304) trial. The study evaluated Keytruda and Padcev, given both before and after surgery in what’s known as a perioperative treatment, and compared the regimen with neoadjuvant chemotherapy followed by surgery.
    • “Keytruda developer Merck & Co. sponsored the study in collaboration with Padcev makers Astellas and Pfizer. The three firms announced the positive top-line readout from an interim analysis Wednesday.”
  • and
    • “Armed with new three-year data demonstrating the benefits of Anktiva in a specific patient subset, ImmunityBio is proving its bladder cancer med is still one to watch as it competes with heavy hitters from Merck and Johnson & Johnson.
    • “Last year, the company won a long-sought FDA approval for its drug—used alongside the Bacillus Calmette-Guérin (BCG) vaccine—to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. 
    • “That nod set up a showdown with Merck’s Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin. More recently, the competition has amped up, with Johnson & Johnson’s Inlexzo hitting the scene and putting pressure on IL-15 receptor agonist Anktiva.
    • “Not deterred by the expanding competitive landscape, ImmunityBio is using new data from the company’s Quilt-3.032 study to flesh out Anktiva’s benefits in patients with BCG-unresponsive high-grade papillary-only NMIBC. Papillary tumors and CIS are the two clonally linked subtypes of NMIBC, ImmunityBio explained in a Dec. 16 press release. 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Oscar Health, Angle Health, Curative, Centivo and Sidecar Health are testing the market for alternative health plans.
    • “Options such as variable copay plans and individual coverage health reimbursement arrangements may appeal to employers seeking to cut costs.
    • “Leading insurers such as UnitedHealthcare, Aetna, Cigna, and Blue Cross and Blue Shield companies are active in this market.
    • “More than one-third of large businesses will offer nontraditional health benefits in 2026, according to Mercer.”
  • Fierce Healthcare relates,
    • “Cigna’s Evernorth launched a behavioral-health-focused medical group in 2024 to meet the demand for behavioral health therapy and support.
    • “In the past 18 months, Evernorth has expanded its Behavioral Care Group from virtual services in six markets and a network of 1,000 providers to more than 5,000 providers across all 50 states.
    • “Evernorth now plans to grow the medical group to more than 15,000 providers next year.
    • “The medical group also now offers in-person appointments to complement its virtual care services. Evernorth executives say this hybrid approach allows patients to choose the care setting that best suits their needs without compromising on quality or convenience.”
  • BioPharma Dive points out,
    • “Biotechnology startup Orum Therapeutics has banked 146 billion Korean won, or about $100 million, to fuel development of medicines that merge elements of two popular drugmaking approaches.
    • “Orum on Thursday said that proceeds from the round — which was led by KB Investments and involved seven other firms — will help advance a potential acute myeloid leukemia drug called ORM-1153 and that recently became its top candidate.
    • “The startup, which has offices in Cambridge, Massachusetts, and Daejeon, South Korea, is developing what are known as “degrader-antibody conjugates.” These drugs are a twist on the antibody-drug conjugates, or ADCs, used to treat multiple cancers. ADCs link a targeting molecule to a tumor-killing toxin. Orum’s drugs, by comparison, use a protein-degrading compound as a payload.”
  • Per Axios,
    • “Employer-sponsored insurance may be getting costlier, but it still delivers a positive return for firms that cover their workers, according to a new Avalere Health analysis commissioned by the U.S. Chamber of Commerce and provided first to Axios.
    • “Why it matters: Workplace insurance is the backbone of the American health care system, covering around half of the population. Whether it’s a well-functioning system or not, workers and families depend on it.
    • “What they found: The analysis measured what companies get back from each dollar invested in health benefits and concluded benefits exceeded costs for firms of all sizes this year, and that ROI will only grow through 2029.
    • “Employer insurance will yield an estimated 120% ROI to employers in the aggregate in 2025 and a 137% return in 2029, per the analysis.
    • “That comes from increased productivity, tax benefits and increased retention.”

Tuesday report

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

From Washington, DC,

  • Politico reports,
    • “A bipartisan group of nearly two dozen senators huddled Monday night to work out an 11th-hour health care deal to extend Affordable Care Act insurance subsidies set to expire at the end of this month.
    • “At a meeting convened by Sens. Susan Collins (R-Maine) and Bernie Moreno(R-Ohio), the senators discussed a two-year extension of the Obamacare tax credits that would be coupled with a new income eligibility cap and fraud prevention language.
  • The Wall Street Journal adds,
    • “Senate Majority Leader John Thune (R., S.D.) said Congress won’t be able to extend federal health-insurance subsidies before leaving for the holidays, ending hopes for a last-minute deal and punting any possible fix into the new year.
    • “We’re not going to pass anything by the end of this week, but I do think there’s a potential pathway in January,” Thune said at a press conference on Tuesday. Lawmakers are expected to depart Washington before the weekend and won’t return until Jan. 5.” * * *
    • “House Republicans still are expected to pass a GOP healthcare bill on Wednesday that would expand access to association health plans, which generally allow small employers to band together and provide health insurance, and appropriate money to fund the cost-sharing reductions that reduce out-of-pocket spending for lower-income ACA enrollees. It doesn’t include any ACA extensions or the health savings accounts favored by many Republicans. 
    • “The Congressional Budget Office said the bill would reduce the federal deficit by $35.6 billion over a decade, but it would also reduce the number of people with health insurance by an average of 100,000 a year.” 
  • OPM Director Scott Kupor added a post about the new U.S. Tech Force to his Secrets of OPM blog today.
  • Federal News Network adds,
    • “Agencies will soon see a more streamlined process for potentially offering higher-value bonuses to federal employees who are being hired or relocated.
    • “A new final rule from the Office of Personnel Management on Tuesday seeks to reduce “administrative burden” and “increase efficiency” in the process for approving recruitment and relocation incentives. The changes come after OPM first proposed regulations in November 2023.
    • “In practice, OPM’s changes will shift the transactional work of approving waivers for larger bonuses off of OPM’s plate, and instead make it the responsibility of individual agencies. The goal is make the process for offering pay incentives easier, and in theory free up time for OPM to focus on other priorities, according to the final rule.”
  • HHS Assistant Secretary for Technology Steve Posnak remarks in his agency’s HealthBuzz blog
    • In July the Centers for Medicare & Medicaid Services (CMS) launched an ambitious Health Technology Ecosystem pledge program. The groundswell of energy and enthusiasm for the program has been remarkable, and we’re glad to be their partner. CMS established several pledge categories associated with aspirational criteria included within its CMS Interoperability Framework. This [HealthBuzz] post looks specifically at the similarities and differences between the Trusted Exchange Framework and Common Agreement™ (TEFCA™) and the “CMS-Aligned Network” pledge category.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Harvey Risch, M.D., Ph.D., as chairman of the President’s Cancer Panel. The panel, part of the National Institutes of Health’s (NIH) National Cancer Institute, is charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the president on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.”
  • Per a GAO news release,
    • “Congress created USPS to be financially self-sufficient. However, USPS has lost billions since 2007 as people use mail less and costs increase. As a result, USPS’s financial viability has been on our High Risk list since 2009.
    • “USPS has tried to improve financially by raising prices and making operational changes. Congress also passed legislation to reduce some of USPS’s expenses. More must be done. But USPS hasn’t projected how its changes, like transporting more mail on trucks, may affect its future revenue, expenses, and more. USPS and Congress need these projections to determine what other steps to take. Our recommendation addresses this.”

From the Food and Drug Administration front,

  • Biopharma Dive reports,
    • “The Food and Drug Administration on Monday granted a key approval for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing a regimen involving the drug as an initial treatment for HER2-positive breast cancer. 
    • “The approval issued Monday comes well ahead of the FDA’s Jan. 23 decision deadline and greenlights a combination of Enhertu and Roche’s targeted therapy Perjeta for frontline use in people whose metastatic breast cancer is confirmed to be HER2-positive by an FDA-approved test. The clearance is based on results published in the New England Journal of Medicine earlier this year, which showed the Enhertu-Perjeta regimen was more beneficial than the current first-line standard, a combination of chemotherapy and precision drugs that’s known as THP.” 
  • MedTech Dive notes,
    • “The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance of artificial intelligence in medical devices. 
    • “The feedback diverged, with patients calling for stronger postmarket reporting and medical groups saying reporting should be the responsibility of manufacturers. Device companies, meanwhile, called for the FDA to use its existing regulatory frameworks instead of introducing new requirements.
    • “The FDA’s emphasis on real-world performance comes as the agency considers how to regulate increasingly complex technologies, such as generative AI, and how to ensure the performance of AI models doesn’t degrade over time.” 

From the public health and medical / Rx research front,

  • Per HHS news releases,
    • “The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. Early detection of both conditions allows children to receive FDA-approved therapies at the most effective time, helping to slow disease progression and preserve their quality of life.
    • “As my uncle has said, ‘although children may be the victims of fate, they will not be the victims of our neglect,’” said Secretary Kennedy. “This action honors that principle. Early screening gives every child a fair chance at timely, effective care, and it delivers families the answers and treatment options they deserve—right when they need them most.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.” * * *
    • “The CDC is reviewing ACIP’s secondary recommendation that parents should consult with a health care provider on serology testing to determine whether a subsequent hepatitis B vaccine dose is needed. For infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine and immunoglobulin continues with no change.
    • “The adoption of individual-based decision-making for hepatitis B immunization maintains consistency of coverage through all payment mechanisms, including entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.
    • “Fact Sheet: Hepatitis B Immunization“
  • Per MedTech Dive,
    • “The Centers for Medicare and Medicaid Services will reconsider its national coverage determination for transcatheter aortic valve replacement in response to a request from Edwards Lifesciences, according to an agency posting on Monday.
    • “Edwards, in a July letter, asked the agency to reconsider its current policy for TAVR patients who are Medicare beneficiaries to reflect new evidence demonstrating improved outcomes when the valves are used to treat asymptomatic patients. Those patients are currently beyond the scope of Medicare coverage for the treatment.
    • “Analysts expect expanded Medicare coverage to drive further adoption of TAVR. William Blair analyst Brandon Vazquez said one-third of severe aortic stenosis patients are estimated to be asymptomatic. Broader reimbursement could also prompt more hospitals to open TAVR centers, Vazquez said.”
  • The New York Times reports,
    • “For a while, it seemed the notion that light drinking was good for the heart had gone by the wayside, debunked by new studies and overshadowed by warnings that alcohol causes cancer.
    • “Now the American Heart Association has revived the idea in a scientific review that is drawing intense criticism, setting off a new round of debate about alcohol consumption.
    • “The paper, which sought to summarize the latest research and was aimed at practicing cardiologists, concluded that light drinking — one to two drinks a day — posed no risk for coronary disease, stroke, sudden death and possibly heart failure, and may even reduce the risk of developing these conditions.
    • “Controversy over the influential organization’s review has been simmering since it was published in the association’s journal Circulation in July.”
  • Per Fierce Pharma,
    • “With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.
    • “In Gilead’s Artistry-2 study, the company’s single-tablet regimen of bictegravir and lenacapavir matched up to Gilead’s own megablockbuster HIV medicine Biktarvy when assessing patients’ treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.”
  • Per MedPage Today,
    • “More than 70% of patients with advanced triple-negative breast cancer (TNBC) responded to an investigational bispecific antibody targeting PD-L1 and VEGF-A plus chemotherapy, a preliminary study showed.
    • “Overall, 71.8% (61.5% confirmed) of patients had partial responses to either of two dose levels of pumitamig plus nab-paclitaxel (Abraxane), and 23.1% had stable disease, resulting in a disease control rate of 94.9%. Tumor shrinkage occurred in all but five evaluable patients, averaging 42.6% for the entire cohort.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “With COVID sales falling and patent protections expiring, Pfizer is forecasting its 2026 revenue to be in the range of $59.5 billion to $62.5 billion. The midpoint of the projection ($61 billion) would be a decline from this year’s estimated revenue of $62 billion—which the company reaffirmed on Tuesday. It would also be an additional slide from Pfizer’s 2024 revenue of $63.6 billion.
    • “Built into the 2026 guidance is a $1.5 billion decline in sales of its COVID products—from an estimated $6.5 billion this year to $5 billion in expected sales next year. The company also expects to sustain a $1.5 billion hit from the loss of exclusivity (LOE) of its products.
    • “As those LOEs escalate in the coming years—to $3 billion-plus in 2027 and $6-plus in 2028—the drugmaker said that it doesn’t expect to see growth until 2029.”
  • Modern Healthcare relates,
    • “Medline Inc. raised $6.26 billion in the year’s biggest initial public offering, upsizing the deal and pricing the shares near the top of the marketed range.
    • “The company sold 216 million shares Tuesday for $29 each, according to a statement confirming a Bloomberg News report. Medline, which counts Blackstone Inc., Carlyle Group Inc. and Hellman & Friedman among its backers, had marketed 179 million shares for $26 to $30 each.
    • “The pricing gives the company a market value of about $39 billion, based on the number of shares listed in its filings with the U.S. Securities and Exchange Commission.
    • “Medline manufactures and distributes medical supplies such as gloves, gowns and exam tables used by hospitals and doctors. The three private equity firms sealed a $34 billion deal to acquire a majority stake in the company in 2021, in one of the largest leveraged buyouts of all time.” 
  • and
    • “City of Hope has opened Orange County’s first hospital exclusively dedicated to cancer care, marking a major milestone in the organization’s commitment to increasing access to advanced cancer treatment and research across the country. 
    • “The cancer specialty hospital, which began seeing patients Dec. 1, sits on City of Hope Orange County’s 72-acre academic campus in Irvine, California, and is connected to City of Hope Orange County Lennar Foundation Cancer Center, which opened in 2022. The opening completes a full continuum of cancer services in the region, enabling patients to access advanced inpatient and outpatient care, clinical trials and surgical oncology services without having to leave the region. Before City of Hope arrived in Orange County, as many as 20% of local cancer patients left the area to receive advanced cancer care, according to the organization. 
    • “We want every person to have options and access to the most skilled teams, the most cutting-edge treatments and the best research to give them the best chance of survival — this new hospital is part of that journey,” said Robert Stone, CEO of City of Hope.”
  • Per Healthcare Dive,
    • “Cencora is acquiring a majority stake in OneOncology, a support platform for cancer care practices, for $5 billion as the drug distributor ramps up its specialty services offerings.
    • “Cencora already owned a stake in OneOncology, but has signed a definitive agreement to acquire most of the remaining shares from investment firm TPG and other holders for $3.6 billion, and to pay off $1.3 billion of OneOncology’s debt.
    • “OneOncology’s practices will retain a minority interest in the company, according to a release. Cencora expects deal to close by the second fiscal quarter next year.”
  • Beckers Clinical Leadership points out,
    • “Concierge and direct primary care models are rapidly reshaping the U.S. primary care landscape. These membership-based practices, which charge monthly or annual fees for enhanced access and longer visits, have increased in recent years — often operating outside the traditional insurance system.
    • “A research article published in December in Health Affairs by researchers from Baltimore-based Johns Hopkins University, Portland-based Oregon Health & Science University and Boston-based Harvard Medical School found that such practices increased by more than 80% between 2018 and 2023, raising questions about equity, access and the future of the physician workforce.”
  • Lockton issued its 2025 high cost claimant report.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.
    • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.”
    • “What’s changing is not only the magnitude of these claims, but also the instability. Only 21% of high-cost claimants (HCCs) persist year over year, increasing renewal uncertainty and complicating forecasting.”
  • Per an Institute for Clinicial and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. The final report includes key policy recommendations to help ensure fair access.
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations “

Monday report

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

From Washington, DC,

  • The American Hospital Association News informs us,
    • “Approximately 950,000 consumers who currently do not have health insurance coverage through the federally facilitated Health Insurance Marketplace have signed up for a 2026 health plan, the Centers for Medicare & Medicaid Services announced Dec. 5. More than 4.8 million returning consumers have selected 2026 plans. The open enrollment period began Nov. 1 and continues through Jan. 15. Today is the final day for consumers to enroll in coverage that would begin Jan. 1. For those enrolling after Dec. 15, coverage would begin Feb. 1.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 published the Measures Under Consideration List for 2025. These are measures that CMS is considering adopting through the federal rulemaking process for use in Medicare programs. This year’s list comprises 24 unique measures, with some under consideration for multiple CMS programs and others already in use but undergoing substantial change to their specifications. Notably, several measures address topics consistent with the Department of Health and Human Services’ Make America Health Again priority framework, such as chronic illness and nutrition, and all 24 measures rely on data submissions using at least one digital source. In addition, CMS is promoting the early review of five measures that align with the MAHA initiative and are currently in the development stage. 
    • “CMS will convene a consensus-based multidisciplinary group, on which the AHA sits, to provide recommendations to the agency on these measures by Feb. 1. In addition, CMS will seek input through public comments from Dec. 16 through Jan. 6.” 
  • Per a CMS fact sheet,
    • “All seven of CMS’ A/B Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers that will be effective January 1, 2026.”
  • Per HHS news releases,
    • “Ralph Abraham, M.D., was sworn in today as Principal Deputy Director of the Centers for Disease Control and Prevention (CDC) by Health and Human Services Secretary Robert F. Kennedy, Jr. He will begin his duties at CDC headquarters in Atlanta on January 5, 2026.
    • “Dr. Abraham has nearly 30 years of experience as a medical practitioner, most recently as Surgeon General of the state of Louisiana. As CDC Principal Deputy Director, he will help realign the agency with its mission as America’s frontline defender against infectious disease.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today convened Lyme disease patients, clinicians, and researchers for a roundtable on diagnostics and clinical needs moderated by HHS Secretary Robert F. Kennedy, Jr. The event fulfills commitments made in the Make America Healthy Again Commission Strategy Report [PDF, 21.85 MB] to address chronic and often unseen illnesses that affect millions of Americans.
    • “For decades, Americans suffering from Lyme disease have been denied the accurate diagnostics and meaningful care they deserve,” said Secretary Kennedy. “Today’s actions push us decisively toward reliable testing and treatment grounded in the real-world experiences of patients. We are committed to delivering the tools that families have waited far too long to receive.”
    • “Participants shared their experiences and recommendations on improving care and advancing research. Senator Susan Collins (R-ME) and Representatives Morgan Griffith (R-VA) and Chris Smith (R-NJ) also engaged in the discussions.
    • “As part of today’s event, HHS announced the renewal of the LymeX Innovation Accelerator with the Steven & Alexandra Cohen Foundation that began during President Trump’s first term. Established in 2020, LymeX is the largest public-private partnership ever built to improve Lyme disease diagnostics and care. The $10 million initiative will advance artificial intelligence tools that support earlier and more accurate detection across stages of infection.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in coordination with the Office of Management and Budget (OMB), the General Services Administration (GSA), the White House Office of Science Technology and Policy (OSTP), and agency leaders across the administration, today announced the establishment of the United States Tech Force (Tech Force)– a new, cross-government program to recruit top technologists to modernize the federal government.” * * *
    • “OPM is proud to announce the initial private sector partners for Tech Force: Adobe, Amazon Web Services, AMD, Anduril, Apple, Box, C3.ai, Coinbase, Databricks, Dell Technologies, Docusign, Google Public Sector, IBM, Meta, Microsoft, Nvidia, OpenAI, Oracle, Palantir, Robinhood, Salesforce, SAP, ServiceNow, Snowflake, Synopsys, Uber, Workday, xAI, and Zoom. OPM welcomes the opportunity to expand this list of partners over time.
    • “In addition, Tech Force is partnering with NobleReach Foundation – a nonpartisan talent platform that brings together America’s best and brightest across industry, academia, and government via initiatives such as its NobleReach Scholars Program – to recruit technologists and support the program.
    • “Read more of what government and tech world leaders have to say about Tech Force here.
    • “For further information, please see OPM’s memo to agencies here. To learn more or apply for Tech Force and for FAQ’s visit TechForce.gov. And follow US Tech Force on X.”  

From the Food and Drug Administration front,

  • Per FDA news releases,
    • “The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. The FDA similarly intends to consider updating its guidance for drugs and biologics.”
  • and
    • “The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations –infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.”
  • Fierce Pharma reports,
    • “Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history.
    • “The U.S. regulator has signed off on Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. Cardamyst becomes the first self-administered treatment patients can use to manage their PSVT symptoms.
    • “The calcium channel blocker is a convenient alternative to an emergency room visit, where patients receive an intravenous dose of a drug that “basically reboots your heart,” Milestone CEO Joe Oliveto said in an interview.
  • and
    • “LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga.
    • “The injected treatment, which will carry the commercial name Lerochol, is approved to be used along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
    • “Lerochol arrives on the market with a convenience edge over other PCSK9 drugs, as it is self-administered once monthly and doesn’t need refrigeration because it retains its stability for up to three months at room temperature. By comparison, Amgen’s Repatha and Sanofi and Regeneron’s Praluent are dosed between every two to four weeks, depending on patient needs, and have a shorter shelf life at room temperature.”
  • and
    • “Johnson & Johnson’s Akeega is opening new fronts in prostate cancer treatment with a fresh FDA approval, making it the first precision medicine combo for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
    • “Akeega, a dual-action tablet made up of J&J’s androgen-directed prostate cancer med Zytiga (abiraterone acetate) and the PARP inhibitor niraparib—sold by GSK as Zejula in other indications—is added to corticosteroid medication prednisone to delay disease progression of the aggressive form of prostate cancer.  
    • “J&J’s Amplitude study was the first showing that a PARP inhibitor-androgen receptor pathway inhibitor treatment combination could delay both radiographic and symptomatic disease progression in the disease type, Dana-Farber Cancer Institute’s Bradley McGregor, M.D., noted in a company press release.“
  • and
    • “The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday.
    • “The voucher was granted to J&J for its proposed combination of Tecvayli and Darzalex for previously treated multiple myeloma.
    • “With the voucher, the FDA aims to deliver a decision within one to two months following submission of an application. Normally, FDA drug reviews take up to 10 months, starting from the acceptance of an application.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “A new drug has been saturating the fentanyl supply in Philadelphia and moving to other cities throughout the East and Midwestern United States: medetomidine, a powerful veterinary sedative that causes almost instantaneous blackouts and, if not used every few hours, brings on life-threatening withdrawal symptoms.
    • “It has created a new type of drug crisis — one that is occasioned not by overdosing on the drug, but by withdrawing from it.
    • “Since the middle of last year, Philadelphia’s hospitals have been strained by patients coming in with what doctors have identified as medetomidine withdrawal. Although the heart rate slows drastically right after use, in withdrawal the opposite occurs: The heart rate and blood pressure become catastrophically high. Patients experience tremors and unstoppable vomiting. Many require intensive care.”
  • The Wall Street Journal relates,
    • “People susceptible to developing heart issues benefit the most from reducing their consumption of saturated fats, according to a review of research that comes as the federal government prepares to revise dietary recommendations.
    • ‘A paper published Monday in the Annals of Internal Medicine found that people at high risk of developing cardiovascular problems saw a reduction in major health issues including heart attack and stroke when they cut back on saturated fats. The picture was different for people without those same cardiovascular risks. Within five years, cutting saturated fats didn’t yield the same benefits for that group, the review said.”
  • The Washington Post tells us,
    • “Why some people experience long-lasting physical and mental effects from covid-19 could be linked to chronic inflammation, according to new research that experts say could help develop new treatments for the confounding condition that continues to afflict millions.
    • “Some early research on the condition has suggested that long covid’s symptoms linger because the virus persists in people’s bodies. But the new study published Friday in Nature Immunology found that people with long covid had activated immune defenses and heightened inflammatory responses for more than six months after initial infection compared with those who fully recovered.
    • “The latest research “leads to a hypothesis that there might be therapeutic targets related to inflammation that might be worth exploring in clinical studies,” said Dan Barouch, the study’s lead author and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
    • “The study’s findings signal progress in understanding a condition that is estimated to affect more than 400 million individuals around the world as the coronavirus continues to infect people every day, said Ziyad Al-Aly, a clinical epidemiologist at Washington University in St. Louis who studies long covid. There are no drugs approved for treatment of long covid, leaving doctors to tackle individual symptoms with various therapies.”
  • The American Medical Association lets us know “What doctors wish parents knew about fall prevention for kids.
    • “Rabia Nagda, MD, of Texas Children’s Pediatrics, emphasizes that every environment where kids spend time should be built with fall risk in mind.”
  • Per MedPage Today,
    • “Cannabis use in pregnancy is associated with health risks including preeclampsia and low birthweight.
    • “In this secret shopper study, one in five cannabis retailers told callers that cannabis use was safe in pregnancy.
    • “The findings support a need for more public education about the risks of prenatal cannabis use and for guidance to discuss its use with physicians.”
  • Per Health Day,
    • “‘Dual use’ of vaping and smoking might help smokers cut back or quit.
    • “Smokers who also vaped were 4.5 times more likely to quit within a year.
    • “Dual users were also more likely to cut their smoking by half.”
  • and
    • “People could learn within 15 minutes whether they are infected with hepatitis C, thanks to a rapid test developed by Northwestern University.
    • “The test will allow doctors to diagnose infections during an office visit and kickstart patients’ treatment before they leave, researchers said.
    • “This test could revolutionize HCV care in the U.S. and globally by dramatically improving diagnosis, accelerating treatment uptake and enabling more people to be cured faster,” researcher Dr. Claudia Hawkins said in a news release. She’s director of Northwestern’s Institute for Global Health’s Center for Global Communicable and Emerging Infectious Diseases in Chicago.”
  • STAT News reports,
    • “Gene therapy researchers were converging on a holy grail. A few years ago, researchers at labs and companies reported they had engineered viruses that could ferry corrective genes deep into the brain, giving potential entry to a new world of treatments for Alzheimer’s, Parkinson’s, and a slew of rare genetic diseases.
    • “This summer, after years of careful study, the first person underwent gene therapy using one of the new viruses. The patient, a young child, died two and a half days later.
    • “The death has sent concern and uncertainty rippling through labs and companies developing gene therapies for the brain, along with rare disease groups who hoped these tools could deliver long-sought cures. They worry that Capsida Biotherapeutics unearthed a broader risk for other viruses designed to travel like a messenger pigeon to our brains, one that could derail years of progress. 
    • “Capsida has declined to answer questions about the death beyond a brief statement. Its CEO has departed. The information that has leaked out is troubling. The child died of cerebral edema — brain swelling — a clinical course distinct from other deaths tied to gene therapy over the last decade, according to a person familiar with the matter.
    • “Most disturbingly, none of the animal and lab studies Capsida presented indicated such a calamity was possible, making it unclear how other researchers and companies would test for such a risk.” * * *
    • “The best path ahead may be to start new trials in very low doses. But that’s challenging in gene therapy, where patients can only ever receive one dose of a virus in their lifetime, before they develop immunity to it. Still, “we may have to be a bit more conservative,” said Miguel Sena-Esteves, a gene therapy researcher at the UMass Chan Medical School 
    • “Alternatively, companies may have to move forward first in diseases otherwise immediately fatal, where the risk-benefit calculus shifts dramatically. The prion disease that shadows Sonia Vallabh, a researcher at the Broad Institute, is one. 
    • “Whichever way it goes, the gene therapy field has lost the assurance — already tenuous — that tests in animals can predict the toxicities for us. 
    • “In some way,” Vallabh said, “our only safety species is humans.”
  • The Wall Street Journal adds,
    • “Sanofi said its tolebrutinib drug candidate didn’t meet the primary goal in a late-stage clinical trial for multiple sclerosis. It separately said talks with the U.S. Food and Drug Administration had indicated a regulatory review for tolebrutinib in a different form of the disease would take longer than previously expected.
    • “The updates deal a blow to one of the most advanced drugs in Sanofi’s pipeline as the company seeks to move past recent disappointments in clinical trials. Sanofi has turned to dealmaking this year, using funds raised from the sale of a controlling stake in its consumer-healthcare business to replenish its pipeline.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark released its third quarter earnings report on Monday, where its top brass said the insurer expects to see elevated utilization trends persist into 2026.
    • “The Pittsburgh-based organization, which includes Highmark Health Plans and health system Allegheny Health Network, reported a $69 million net loss and a $204 million operating loss alongside $24.6 billion in revenue through the first nine months of 2025. The bulk of that loss came from the health insurance unit, which is continuing to be pressured by care use.
    • “Carl Daley, chief financial officer and treasurer at Highmark Health, told Fierce Healthcare that the company had expected utilization to normalize over the course of the year, and priced plans accordingly. It’s made adjustments in its pricing strategy for 2026 to adapt to the expectation that utilization remains high.”
  • MedTech Dive tells us,
    • “Philips has agreed to acquire SpectraWAVE, a firm making tools to help diagnose and guide treatment of coronary artery disease, the companies announced Monday. They did not disclose the terms of the deal.
    • “SpectraWAVE makes an intravascular imaging system for the coronary arteries. The Bedford, Massachusetts-based company also makes an AI-enabled solution that calculates fractional flow reserve from a single coronary angiogram to support treatment decisions. 
    • “Philips expects the acquisition will expand its portfolio of intravascular imaging and physiological assessment devices. CEO Roy Jakobs said in a statement that the company is “doubling down on image-guided therapy” and expanding its coronary intervention portfolio with the planned purchase.”
  • Cardiovascular Business adds,
    • “Ambulatory surgical centers (ASCs) and office-based labs (OBLs) are poised to play a growing role in cardiovascular care as payment policies shift and health systems look for more efficient ways to manage procedural volume. That trend, and the guardrails needed to ensure patient safety, was the focus of an educational session at TCT 2025 in San Francisco. 
    • “Cardiovascular Business spoke with one of the presenters, Arnold Seto, MD, cath lab director at the Long Beach VA Medical Center, professor of medicine at Charles Drew University, Society for Cardiovascular Angiography and Interventions (SCAI) treasurer and chair of the SCAI Advocacy Committee, to find out more.
    • “Seto said there is wide expectation that lower-acuity interventional cardiology and peripheral procedures will migrate into the ASC environment. This is partly due to better cost effectiveness and the fact that larger centers want to expand into more complex and structural heart procedures without building out their hospital cath labs to be bigger.
    • “The consultants tell us that as many as 25% to 50% of cardiology procedures will be migrating to the ASC environment. The government would prefer that because they pay about two-thirds of the hospital outpatient costs compared with an ASC reimbursement,” he said. He added that the Center of Medicare and Medicaid Services (CMS) is clearly signaling interest in this shift. “We’ve already seen CMS effectively remove all the PCI codes from the inpatient only list, and actually talk about removing everything from the inpatient only list.”
  • Per a Leapfrog news release,
    • “Today, The Leapfrog Group, a national watchdog organization of employers and other purchasers focused on health care safety and quality, announced the 2025 recipients for their elite annual Top Hospital Award and Top Ambulatory Surgery Center (ASC) Award. This national recognition is one of the most competitive honors U.S. hospitals and surgery centers can earn for excellence in patient safety and quality of care. Selected hospitals and ASCs will be celebrated today as part of Leapfrog’s 2025 Annual Meeting and Awards Dinner.” * * *
    • “The award honors hospitals and ASCs that demonstrate the highest performance in the nation on quality and patient safety, including ethical billing and informed patient consent procedures, lower infection rates, prevention of medication errors and surgical safety. To see the full methodology and list of institutions honored as 2025 Top Hospitals, please visit www.leapfroggroup.org/tophospitals. To see the full list of institutions honored as 2025 Top ASCs, please visit www.leapfroggroup.org/ratings-report/top-ascs.” 
  • Genetic Engineering and Biotechnology News points out,
    • “As Eli Lilly (NYSE: LLY) and Novo Nordisk (Nasdaq Copenhagen: NOVO-B) scramble to bring an oral glucagon-like peptide 1 (GLP-1) receptor agonist to market for obesity, a much smaller potential rival spotlighted positive mid-stage clinical data that captivated investors enough to send its share price more than doubling this past week.
    • “Structure Therapeutics (NASDAQ: GPCR) shares soared 102% after it reported positive data from its Phase II ACCESS clinical program assessing its oral GLP-1 candidate aleniglipron in people with obesity and/or overweight with at least one weight-related co-morbidity. Aleniglipron (formerly GSBR-1290) is designed to be a biased G protein-coupled receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway.”
    • “If approved, Structure would compete with oral GLP-1s for weight management by the leading obesity drug developers, whose candidates could both win FDA approval in the new year.”
  • MedCity News notes,
    • “This Year’s Hottest Healthcare Company Isn’t Even a Healthcare Company
    • “Nvidia has quietly become one of the most influential players in healthcare technology by supplying the accelerated computing and AI infrastructure that powers everything from imaging to drug discovery. The company’s restraint — focusing on enabling the ecosystem rather than owning it — has helped cement its role as the indispensable backbone of the healthcare industry’s AI transformation.”