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.”