From Washington, DC,
- Healthcare Dive reports,
- “The House voted 230-196 on Thursday to extend expired subsidies for Affordable Care Act plans for three years, with 17 Republicans joining their colleagues across the aisle in support.
- “The vote sends the bill to the Senate, where it’s expected to be dead on arrival. Though, some moderate senators are working on a compromise proposal, and the support for an extension could push the group to arrive at a solution.”
- STAT News adds,
- “A large bipartisan group of House and Senate lawmakers met hours before the vote to discuss plans for a Senate compromise on the subsidies. They left the meeting sounding optimistic, though there are still important details to be worked out.
- “From the sounds of it, the Senate is planning on finalizing some text by Monday or Tuesday of next week with what their framework will look like,” said Rep. Rob Bresnahan (R-Pa.) as he left the meeting.”
- Per an OPM news release,
- “The US Office of Personnel Management (OPM) today announced the launch of the Federal Workforce Data (FWD) website, a modern platform that replaces the outdated FedScope system and delivers faster, more transparent access to federal workforce data.
- “The new site, available at data.opm.gov, introduces predictable monthly data updates, interactive visualizations, downloadable datasets, and improved transparency around data quality addressing long-standing challenges with delayed releases and limited usability under FedScope.
- “The Federal Workforce Data website delivers timely, transparent data in a format that is easy to use and built for the future,” OPM Director Scott Kupor said. “This is a major step forward for accountability and data-driven decision-making across government.”
- “The FWD website also expands publicly available workforce information, including new data on retirement eligibility, telework and remote work, administrative leave, performance ratings, and federal hiring activity.
- ‘OPM will continue releasing new data, visuals, and features on the site each month and will iterate on the platform as user feedback is received. This launch represents just the beginning, with regular updates and new enhancements planned on an ongoing basis.”
- Bloomberg Law tells us,
- “Eli Lilly & Co. plans to take part in the Trump administration’s drug pricing model that seeks to expand access to diabetes and obesity treatments covered under Medicare and Medicaid.
- “Consistent with a November 2025 agreement with the Trump administration to expand access to obesity medicines and reduce patient costs, “Lilly plans to participate in the voluntary BALANCE model to expand access to GLP-1s in both Medicare and Medicaid,” a company spokesperson said in an email.
- “The model “will reflect the same terms we have already agreed to regarding GLP-1 pricing and coverage criteria,” said the company, which manufacturers obesity and diabetes drugs Zepbound and Mounjaro.”
- The Wall Street Journal informs us,
- “Sending time-sensitive documents like college applications, check payments, tax returns, insurance appeals and ballots through the mail?
- “You might want to drop off the letter a few days earlier or head to the post office and ask a mail clerk to manually postmark the letter if getting proof of the date is required for meeting a deadline. Otherwise, you risk missing an important deadline for sending your mail.
- “Since Dec. 24, a postmark no longer shows the date you deposited a piece of mail with the U.S. Postal Service. That means a letter dropped in a mailbox on Monday could be postmarked on Wednesday, if that was the day it got to a processing facility.”
- Per a PCMA news release,
- “Marking a new era for the organization, today the board of directors of the Pharmaceutical Care Management Association (PCMA) [, a PBM trade association,] announced that David Marin has been named its new President and CEO, following a thorough search. Marin brings three decades of public policy and coalition-building experience to PCMA and joins the organization from Viatris, a pharmaceutical manufacturer, where he was global head of government affairs, public policy, and advocacy.
- “Concurrently, the PCMA board announced that Brendan Buck, a seasoned public affairs leader, will serve in the new role of Chief Communications Officer. Both David and Brendan will begin January 20, 2026.”
From the Food and Drug Administration front,
- MedTech Dive reports,
- “FDA exempts more wearable, AI features from oversight. In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.” * * *
- “The first guidance clarifies the FDA’s thinking on what constitutes a wellness device. It offers broader leeway to wearables that provide readings around heart rate, blood pressure and blood glucose, so long as they are intended solely for wellness purposes.” * * *
- “In a separate guidance, the FDA unveiled significant changes to how it regulates clinical decision support tools. The biggest change is to a section describing how the FDA interprets whether software is providing recommendations to healthcare providers. Software that provides a sole medical recommendation can now be exempt from regulation. Under a previous guidance, it would have been considered a medical device.”
- On related note, Beckers Health IT offers “four takeaways from a Jan. 5 Amazon blog post” concerning Amazon’s development of “wearable health AI since its acquisition of startup Bee.”
- Cardiovascular Business reports,
- “Aspire Biopharma, a Florida-based biopharmaceutical company, met with the U.S. Food and Drug Administration (FDA)to discuss the future of its new drug for the emergency treatment of suspected heart attacks.
- “The drug in question is acetylsalicylic acid 162 mg sublingual powder (OTASU). Based on feedback from the FDA, Aspire Biopharma plans on completing a planned multicenter clinical trial that compares OTASU with the current standard of care (two chewed aspirin tablets). The company’s next step will involve submitting a Section 505(b)(2) New Drug Application, an approach for new drug approvals that is typically faster than submitting a 505(b)(1) New Drug Application.”
- “The FDA’s constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients,” Kraig Higginson, interim CEO of Aspire Biopharma, said in a prepared statement. “Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA’s response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners.”
From the judicial front,
- The American Hospital Association News reports,
- “The 1st U.S. Circuit Court of Appeals Jan. 7 denied the government’s motion for a stay in a lawsuit filed by the AHA, the Maine Hospital Association and four safety-net health systems challenging the Department of Health and Human Services’ 340B Rebate Model Pilot Program. This means that the program remains on hold.
- “The 1st Circuit wrote: “In a careful and thorough decision, the district court granted the preliminary injunction. It determined that the federal government had failed to consider the hospitals’ reliance interests and other important aspects of the problem in enacting the new program and that the hospitals would face irreparable harm, including potential closure, without an injunction during the course of the litigation. … We conclude that the federal government has failed to carry its burden of ‘ma[king] a strong showing that [it is] likely to succeed on the merits’ in this appeal and thus deny its stay request.”
- “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The First Circuit recognized that the district court’s decision halting the 340B Rebate Program was ‘careful and thorough’ — and correct. The AHA remains pleased that these courts have put on hold this harmful program that would have a devastating effect on America’s most vulnerable patients and communities, and the hospitals that serve them.”
- “The 1st Circuit ruling follows a Dec. 29 decision from the U.S. District Court of Maine granting a preliminary injunction blocking implementation of the program, which was scheduled to go into effect Jan. 1, 2026.”
- Fierce Healthcare relates,
- “Anthem’s California companies are suing 11 Prime Healthcare facilities, alleging that the hospitals committed fraud by “knowingly flooding” the No Surprises Act’s dispute resolution process.
- “The health insurer said in a complaint filed Monday [in the U.S. District Court for the Central District of California, No. 8:26-cv-00023] that the defendant facilities submitted more than 6,000 ineligible claims to the independent dispute resolution, or IDR, which led to millions in “wrongfully obtained awards.” Anthem said that, in aggregate, the Prime hospitals received $15 million more than the insurer would have paid originally.
- “The typical award through IDR was six times what a contracted provider would have been paid, according to the lawsuit.
- “Anthem alleged in the complaint that Prime Healthcare has acquired facilities that would then cancel contracts with insurers and that the hospitals under its umbrella “aggressively pursued collection” of out-of-network claims.”
From the public health, medical / Rx research front,
- Beckers Hospital Review reports,
- “Some hospitals are postponing elective procedures to preserve capacity as a severe flu season pushes admissions higher and fills emergency departments across the U.S.
- “UnityPoint Health-Des Moines said it will delay some surgeries and procedures requiring overnight admission through Jan. 13 amid a sharp rise in flu cases.
- “Our priority is to focus resources on patients with the most urgent needs while maintaining the highest standard of care,” the system said in a statement to the Des Moines Register on Jan. 8. “We are closely monitoring hospital capacity and will provide updates as needed.”
- “Influenza admissions are climbing nationally, and experts say the peak is still weeks away. CDC data shows more than 33,000 people were hospitalized with the flu during the week ending Dec. 27, and hospital leaders are bracing for continued increases.”
- and
- “As the U.S. confronts one of its most severe flu seasons, Tamiflu, a common antiviral medication to treat influenza, is in shortage in pockets across the country, Bloomberg reported Jan. 7.
- “In Utah, where flu activity is high, pharmacists are not yet reporting supply issues. But in Georgia, where flu activity is very high, drugstores are scrambling for Tamiflu (oseltamivir).
- “Hospitals are also asking if we have it,” Parth Patel, PharmD, a pharmacist at an independent pharmacy in Georgia, told Bloomberg.”
- Fierce Pharma lets us know,
- “As evidence of tirzepatide’s efficacy mounts across a range of cardiometabolic conditions, Eli Lilly has shown that taking the incretin medicine alongside another of its drugs, Taltz, could lead to better outcomes for patients living with both psoriatic arthritis (PsA) and obesity.
- “In an open-label phase 3b trial, the co-administration of Lilly’s IL-17A antagonist Taltz (ixekizumab) and dual GIP/GLP-1 receptor agonist Zepbound (tirzepatide) helped more patients achieve improvements in PsA activity and lose a certain percentage of body weight than Taltz alone, the company reported Thursday.”
- MedPage Today cautions,
- “Weight loss and cardiometabolic benefits were fully reversed within 2 years for people who stopped weight management medications, a systematic review and meta-analysis showed.
- “Adults with overweight or obesity who stopped using weight-loss drugs regained an average of 0.9 lb (95% CI 0.7-1.1) each month and returned to their baseline weight within 1.7 years compared with controls in an analysis of randomized trial data, reported Sam West, PhD, of the University of Oxford in England, and colleagues.
- “All cardiometabolic markers — HbA1c, fasting glucose, cholesterol, triglycerides, and systolic and diastolic blood pressure — were projected to return to baseline within 1.4 years after cessation, the researchers wrote in The BMJopens in a new tab or window.
- “Regardless of initial weight loss, people regained weight faster, by 0.7 lb per month, after stopping weight management medications compared with behavioral weight management programs.”
- “As obesity is a chronic and relapsing condition, prolonged treatment with WMM [weight management medication] may be required to sustain the health benefits,” West and co-authors noted. “This evidence cautions against short term use of WMMs, emphasizes the need for further research into cost effective strategies for long term weight control, and reinforces the importance of primary prevention.”
- “The results didn’t come as much of a surprise to Qi Sun, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School in Boston. It’s “well documented that reduced adherence to, or cessation of, dietary and lifestyle interventions leads to similar patterns of weight regain,” he wrote in an accompanying editorial.”
- CNN Health points out,
- “Common preservatives used to keep food safe and extend shelf life may be linked to a higher risk of several cancers and type 2 diabetes, according to two new studies from France.
- “These are very important findings for preservatives that are not only widely used in the French and European markets, but also in the United States,” said senior author Mathilde Touvier, principal investigator of the NutriNet-Santé study used to conduct the research.
- “The NutriNet-Santé study, which began in 2009, compares over 170,000 participants’ web-based reports on diet and lifestyle with their medical data stored in the French national health care system.
- “These are the two first studies in the world investigating the associations between exposure to these food additives and cancer and type 2 diabetes,” said Touvier, who is also the director of research at France’s National Institute of Health and Medical Research in Paris, “and so we must be very cautious about the message. Obviously, the results need to be confirmed.”
- “Despite those caveats, “the concern raised about preservatives is one more reason among many to emphasize the personal and public health importance of fresh, whole, minimally processed foods, mostly plants,” Dr. David Katz said in an email.”
- MedPage Today notes,
- “Thirty-year outcomes among participants in the Women’s Health Study showed a stepwise increase in major cardiovascular events associated with increasing lipoprotein(a) levels starting around 30-60 mg/dL.
- “Lipoprotein(a) is a highly atherogenic particle considered to be a genetically determined, unmodifiable cardiovascular risk factor with little contribution from lifestyle.
- “These findings support screening to identify individuals with very high lipoprotein(a) levels who may benefit from primary prevention therapies.”
- The Wall Street Journal advises,
- “One in six seniors were prescribed eight or more drugs simultaneously, with over 3.5 million receiving at least one generally avoidable medicine.
- “Older adults should annually inventory their medications, research drug labels and interactions, and consult doctors about potential risks.
- “The Beers Criteria guidelines recommend avoiding certain drugs like benzodiazepines and muscle relaxants for older patients due to side effects.”
- The Genetic Engineering and BioTechnology News lets us know,
- More than 50 million Americans live with chronic pain. Drugs are currently available; however, close to 80% of the 600,000 deaths attributed to drug use in 2019 were related to opioids with about 25% of those deaths caused by opioid overdose. In addition, nearly half of Philadelphians who responded to a 2025 Pew survey reported knowing someone with opioid use disorder (OUD) and one-third knew someone who had died as the result of an overdose. Taken together, novel approaches to pain management are a large, unmet need.
- Now, a gene therapy opens a new avenue for targeting pain centers in the brain while eliminating the risk of addiction from narcotics treatments. This work is published in Nature in the paper, “Mimicking opioid analgesia in cortical pain circuits.”
From the U.S. healthcare business front,
- Beckers Payer Issues reports,
- “The Council for Affordable Quality Healthcare is transitioning away from its nonprofit structure, sharing how the country’s biggest health insurance companies are now serving as owners, according to a Jan. 6 news release.” * * *
- “CAQH was founded by health plans that recognized the need to take unnecessary administrative costs out of the healthcare system,” Mr. Kaja said. “That same determination to solve hard problems and move the industry forward defines CAQH today. The board’s decision reflects our confidence in CAQH’s ability to keep challenging convention and improving how the healthcare system works for everyone.”
- “The release added the restructuring will allow CAQH to further advance products and interoperability.”
- Fierce Healthcare informs us,
- “Pomelo Care launched in 2021 with a virtual maternity care model that supplements traditional pregnancy care by proactively predicting and addressing risk factors.
- “The startup is expanding beyond maternity care to more broadly to serve women’s and children’s health needs and it picked up $92 million in series C funding to fuel its growth. Pomelo Care’s services now span reproductive care, pregnancy, pediatrics and hormonal health as well as perimenopause and menopause. The company also supports long-term preventive care and condition management.
- “The funding round was led by Stripes and backed by Andreessen Horowitz, PLUS Capital, Atomico, BoxGroup and SV Angel. With the series C funding, Pomelo Care is now valued at $1.7 billion, the company said.”
- Fierce Pharma notes,
- “It’s been more than 10 years since the FDA signed off on the U.S.’ first biosimilar product, opening up what was originally expected to be an easily accessible, cheaper drug market featuring heightened competition and potential new savings for patients.
- “Now, more than 80 biosimilar approvals later, the promise of broad biosimilar adoption and lower drug prices hasn’t played out as initially anticipated, leaving the biosimilar market at a critical inflection point as it enters 2026, with policy changes and major patent cliffs creeping ever closer.
- “2025 was marked by “extraordinary change and progress within the biosimilar landscape,” highlighting both the opportunities and the challenges facing the field, Samsung Bioepis’ head of U.S. commercial, Thomas Newcomer, said in the company’s fourth-quarter biosimilar market report.”
- Healthcare Dive identifies “the top healthcare provider trends in 2026. Health systems that address costs, workforce planning and portfolio strategy may be better positioned as reimbursement headwinds intensify this year.”
- MedTech Dive calls attention to “4 medtech topics to watch in 2026. From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.”
