Monday report

OPM

Monday report

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

From Washington, DC,

  • The Hill reports,
    • “The Trump administration on Monday proposed stripping the power of an independent board to review challenges from fired federal workers while barring employees from taking the matter to court.
    • “The new proposed rule would impact federal workers fired through a Reduction in Force (RIF), the process used at 22 different agencies last year as the Trump administration conducted widespread layoffs.
    • “If finalized, any federal worker fired in a future RIF would not be able to plead their case before the quasi-judicial Merit Systems Protection Board (MSPB), which last year found that some agencies had “engaged in a prohibited personnel practice” in firing the workers. 
    • “Instead, any challenges would be reviewed by the Office of Personnel Management (OPM), which last year alongside the Office of Management and Budget instructed agencies to begin RIFs.”
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) proposed regulations to lower health care costs, promote competition, and strengthen program integrity in the Federal and State-Based Health Insurance (Exchanges). The proposed Notice of Benefit and Payment Parameters for 2027 would crack down on fraud and misleading practices by agents and brokers, restore accountability for taxpayer-funded subsidies, and remove federal barriers that have limited plan innovation and driven up premiums—helping ensure coverage is more affordable and works better for consumers, taxpayers, and states.” * * *
    • “To review the proposed rule, visit https://www.federalregister.gov/d/2026-02769. 
    • “Public comments must be submitted by March 11, 2026. 
    • “To review the proposed rule fact sheet, visit https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-payment-parameters-2027-proposed-rule.” 
  • Bloomberg Law adds,
    • “The Notice of Benefit and Payment Parameters from the Centers for Medicare & Medicaid Services would allow certain plans that offer preset dollar amounts for care—such as indemnity plans—to meet the requirements of a “qualified health plan” under the ACA if they demonstrate a sufficient number of doctors would accept the plan’s payment terms.” * * *
    • “The rule likewise expands hardship exemptions to permit more individuals to buy “catastrophic” plans with the lowest level of cost-sharing and coverage, and allows catastrophic plan issuers to offer multi-year terms. The proposal would also permit plans with low deductibles and higher out-of-pocket costs
    • “The rule also reverses changes made under the Biden administration, including requiring insurers to offer standardized plan options that were meant to simplify choices.”
  • Healio observes,
    • “A voluntary program designed to help Medicare Part D beneficiaries manage drug costs[, which took effect last year,] could provide considerable benefit to people with cancer, according to study results.
    • “The Medicare Prescription Payment Plan (M3P) provides flexibility that may ease financial distress — particularly for those with limited or fixed incomes — and reduce the potential for cost-related treatment nonadherence, researchers concluded.”
    • “However, many patients and health care professionals are unaware of the program, according to Aryana Sepassi, PharmD, MAS, assistant professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
    • “After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
    • “The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.”
  • MedPage Today tells us,
    • “Oncology specialists should inform patients about a risk of serious toxicity related to dihydropyrimidine dehydrogenase (DPD) deficiency and should test for DPYD variants before starting treatment with capecitabine (Xeloda) and fluorouracil, the FDA announced.
    • “In a safety update communicationopens in a new tab or window, the agency noted that DPYD encodes DPD, which breaks down more than 80% of fluorouracil. Certain homozygous or compound heterozygous DPYD variants result in complete or near-complete absence of DPD activity, increasing the risk for serious, potentially fatal toxicities when exposed to capecitabine or fluorouracil, which are widely used in cancer treatment. Potential adverse reactions include mucositis, diarrhea, neutropenia, and neurotoxicity. The reactions also can occur in patients who have partial DPD activity.
    • “Capecitabine and fluorouracil, or 5-FU, are routinely used in treatment regimens for breast, colorectal, gastric, and pancreatic cancers.”
  • STAT New informs us,
    • “The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. 
    • “The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments.”
    • “Regenxbio had applied for accelerated approval, a type of conditional market clearance, based on RGX-121’s ability to significantly reduce in the short term a specific biomarker in cerebrospinal fluid believed to correlate with longer-term cognitive improvements in patients with the severe form of Hunter syndrome. 
    • “But the FDA, in its letter rejecting the therapy, raised questions about the appropriateness of using the surrogate biomarker, called CSF HS D2S6, as a predictor of clinical benefit. The agency also questioned the eligibility criteria  Regenxbio used to enroll patients into its clinical trial and the use of a natural history comparator arm, the company said.”  

From the judicial front,

  • Bloomberg Law reports,
    • “Medical providers are testing a new legal strategy to recoup unpaid arbitration awards as health insurers rack up victories in surprise billing disputes.
    • “The shift underscores the difficulties both sides face in arbitration under the No Surprises Act, which requires doctors and insurers to settle most unexpected out-of-network bills themselves rather than balance-billing the patient. The volume of disputes has exposed cracks in the system, leading to a series of lawsuits around ineligible claims, fraud, and unpaid awards.
    • “Courts have largely concluded that the law doesn’t grant doctors the right to sue over unpaid awards in most circumstances. Most recently, the US Supreme Court denied two air ambulance companies’ petition to hear their case after the US Court of Appeals for the Fifth Circuit ruled against them.
    • “Providers are now adapting their legal strategy by arguing insurance companies are guilty of improper denial of benefits under the Employee Retirement Income Security Act and unjust enrichment under common law. Hundreds of cases in the US District Court for the District of New Jersey were paused last month pending a decision on the amended claims in Rowe Plastic Surgery of NJ LLC v. Aetna Life Insurance Co .
    • “But the doctors are likely to face problems, at least in overcoming ERISA preemption on their unjust enrichment claims, said Leslie Howard, co-founder of Cohen Howard, a firm representing out-of-network providers.”
  • The American Hospital Association News relates,
    • “The 5th U.S. Circuit Court of Appeals Feb. 9 affirmed a district court ruling upholding Louisiana’s 340B contract pharmacy law. The state law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. Three drug companies — AbbVie, PhRMA and AstraZeneca — challenged the law, arguing that it was unconstitutional in several ways. “Rejecting those arguments, the appeals court held that Louisiana’s law was not preempted by federal law, did not violate the Fifth Amendment’s Takings Clause, did not violate the Constitution’s Contract Clause and was not unconstitutionally vague. “States regulate pharmacies — and the distribution of drugs to those pharmacies — every day,” the 5th Circuit explained. “Act 358 fits comfortably within that tradition.
    • “The AHA filed friend-of-the-court briefs supporting Louisiana’s law last year.” 
  • The Society for Human Resource Management notes,
    • “On Feb. 6, a federal appeals court vacated a preliminary injunction of two executive orders (EO) — EO 14151 on “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173 on “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — finding they were not unconstitutional on their face. The court had previously stayed the injunction, pending appeal. This ruling was the first by a federal appeals court to find the two EOs facially constitutional. Both EOs focused on infrastructure inside the federal government with an emphasis on contracts and grants.
    • “EO 14173, issued Jan. 21, 2025, “was the most significant EO for the private sector” last year, said W. John Lee, an attorney with Morgan Lewis in Philadelphia. Established on May 19, 2025, the U.S. Department of Justice’s Civil Rights Fraud Initiative “is a direct result of the EO and is a prominent example of how it is reshaping federal enforcement of civil rights law.” EO 14151, issued Jan. 20, 2025, set the tone for EO 14173. EO 14173 reshaped compliance obligations for federal contractors and grantees. It also revoked EO 11246, ending EO-based affirmative action programs for women and minorities.
    • “On Jan. 21, 2025, U.S. Equal Employment Opportunity Commission (EEOC) Chair Andrea Lucas made it clear that the EEOC’s enforcement priorities had shifted in alignment with President Donald Trump’s EOs.
    • “While the 4th U.S. Circuit Court of Appeals vacated the injunction, it sent the case back to the district court for further proceedings and left open the possibility of challenges based on individual application of the EOs.”
  • The Wall Street Journal points out,
    • “A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become.
    • “In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hersof violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines.
    • “The pill from Hims & Hers threatened to undermine Novo Nordisk’s efforts to recapture momentum in the $70 billion weight-loss drug market by providing a lower-cost alternative to a Wegovy pill the Danish company recently launched.
    • “Novo Nordisk has been pulling out the stops to reclaim the momentum it lost to Eli Lilly in the booming market.” 

From the public health and medical / Rx research front,

  • Health Day tells us,
    • “Americans could be facing an uphill battle when it comes to protecting their heart health as they age, a new Cleveland Clinic poll reveals.
    • “Nearly 3 of 4 Americans (72%) feel confident in their ability to maintain heart health as they age, the survey found.
    • “But nearly as many (69%) also report that they have at least one known risk factor for heart disease.
    • “Worse, nearly 1 in 4 (24%) aren’t sure whether they are at increased risk for heart disease, according to the survey.
    • “Healthy aging is about prevention,” said Dr. Samir Kapadia, chair of cardiovascular medicine at the Cleveland Clinic.
    • “Heart disease often develops silently over decades, which is why staying active, understanding your risk factors, and addressing them early can make a profound difference in both quality of life and longevity,” Kapadia said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about the shingles virus.”
    • “If you’ve ever had chickenpox, then the virus that causes shingles is present in your body and can resurface at some point in the future. Find out more.”
  • The New York Times relates,
    • “If you think your daily doses of espresso or Earl Grey sharpen your mind, you just might be right, new science suggests.
    • “A large new study provides evidence of cognitive benefits from coffee and tea — if it’s caffeinated and consumed in moderation: two to three cups of coffee or one to two cups of tea daily.
    • “People who drank that amount for decades had lower chances of developing dementia than people who drank little or no caffeine, the researchers reported. They followed 131,821 participants for up to 43 years.
    • “This is a very large, rigorous study conducted long term among men and women that shows that drinking two or three cups of coffee per day is associated with reduced risk of dementia,” said Aladdin Shadyab, an associate professor of public health and medicine at the University of California, San Diego, who wasn’t involved in the study.”
  • NBC News relates,
    • “Bad,” or LDL, cholesterol is a major risk factor for heart disease and most people are screened for it as part of their yearly physicals.
    • There’s another marker in the blood that may be a better predictor of heart disease risk, a recent large review suggests. But it’s not part of routine blood testing.
    • “Apolipoprotein B (apoB) is a protein that attaches to harmful fat particles in the blood. The apoB protein is found on the surface of harmful lipoproteins like low density lipoprotein, or LDL, that contribute to heart disease. Since each one of the harmful particles contains one apoB molecule, testing for it essentially captures the overall number of harmful plaque-producing compounds.” * * *
    • “ApoB testing is hot among health influencers and increasingly touted in the commercial blood testing market. Recently, the Sweetgreen salad chain — which has tied itself to anti-seed-oil influencers — launched a collaboration with the testing company Function Health and is promoting apoB screening along with its menus.
    • “Dr. Michael Shapiro, a preventive cardiologist and the chair of the American Heart Association Council on Lipidology, Lipoprotein, Metabolism & Thrombosis, said that he typically uses an apoB test in select patients.” * * *
    • “In some cases, insurance may cover the test. If not, it typically costs around $70 at a lab.
    • “There aren’t clear guidelines for what target apoB levels should be. In healthy people, apoB values less than 90 mg/dL are typically considered acceptable, with some saying lower targets closer to 70 mg/dL may be more optimal for preventing heart disease.”
  • MedPage calls attention to
    • “Most women said they preferred clinic-based cervical cancer testing over at-home self-sampling, with demographics and life experiences shaping those preferences, a cross-sectional study indicated.
    • “In a nationally representative survey, 20.4% of women said they would prefer to do their own at-home self-sampling for cervical cancer screening, while 60.8% said they prefer clinic-based testing and 18.8% said they were uncertain on their preference, reported Sanjay Shete, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA.
    • “The survey showed that women who had experienced prejudice or discrimination while receiving medical care had higher odds of preferring self-sampling at home (adjusted OR 1.94, 95% CI 1.16-3.22), while Black women had lower odds of preferring at-home self-sampling compared with their white peers (aOR 0.45, 95% CI 0.21-0.96).
    • “When women were asked why they preferred at-home self-sampling, privacy was the most common reason (54.9%), followed by time constraints (35.1%) and fear of embarrassment (33.4%).”
  • and
    • “The CDC’s Advisory Committee on Immunization Practices recently voted to stop recommending a universal dose of the hepatitis B vaccine at birth.
    • “An evidence review found that universal hepatitis B vaccination at birth is safe, effective, and protective for individual and public health.
    • “There was no improvement in safety or effectiveness with a delayed first dose of the hepatitis B vaccine.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a study using gut microbiome samples from over 11,000 people across 39 countries, a single group of bacteria (CAG-170) has been found in higher numbers in the gut microbiomes of healthy people. CAG-170 remain unculturable in the lab, and are only identifiable from their genetic fingerprints.
    • “Further analysis of CAG-170 revealed the bacteria have the capacity to produce high levels of Vitamin B12 and enzymes that break down a wide range of carbohydrates, sugars, and fibers in our gut. The researchers suggest that Vitamin B12 supports other species of gut bacteria, rather than supporting the humans whose guts it is being produced in. CAG-170 could, in the future, be used as an indicator of our gut microbiome health or serve as the basis for the development of probiotics specifically designed to support and maintain healthy levels of CAG‑170 in the gut.”
  • Per Cardiovascular Business,
    • “An oral PCSK9 inhibitor from Merck is associated with significant reductions in low-density lipoprotein (LDL) cholesterol, according to new data published in The New England Journal of Medicine.[1] All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a major impact on patient care. 
    • “Fewer than half of patients with established atherosclerotic cardiovascular disease currently reach LDL cholesterol goals,” lead author Ann Marie Navar, MD, PhD, an associate professor of cardiology at the University of Texas Southwestern Medical Center in Dallas, said in a statement. “An oral therapy this effective has the potential to dramatically improve our ability to prevent heart attacks and strokes on a population level.”
    • “Back in November, researchers presented initial findings from this study at the American Heart Association’s Scientific Sessions 2025 conference. Now, however, the analysis can be read in full.
    • “The CORALreef Lipids trial focused on nearly 3,000 heart patients with high LDL cholesterol who were randomized to either receive enlicitide, Merck’s experimental oral PCSK9 inhibitor, or a placebo. Two patients received the new drug for every one patient treated with a placebo.”
  • Per Radiology Business,
    • “A new MRI-specific artificial intelligence tool could significantly improve the diagnosis of neurological conditions in busy settings. 
    • “Developed by researchers at the University of Michigan, the tool can read brain scans in just seconds. The tool, named Prima, is a video language model that can simultaneously process video, images and text in real time. Experts involved in its development are hopeful it can help address the rising imaging volumes.
    • “As the global demand for MRI rises and places significant strain on our physicians and health systems, our AI model has potential to reduce burden by improving diagnosis and treatment with fast, accurate information,” said senior study author Todd Hollon, MD, a neurosurgeon at U-M Health. 
    • “Researchers trained Prima using more than 200,000 MRI exams collected at the university over several decades. Imaging data were included alongside patients’ medical histories and clinical indications for the scans. The team tested the model on more than 30,000 brain studies over a one-year period. Unlike earlier AI tools that focus on just one disease, Prima was designed to analyze all available imaging and clinical information at once, similar to how a radiologist reviews a case, giving it broad applicability.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Kaiser Permanente nearly tripled its operating income last year, even as the integrated healthcare conglomerate weathered rising expenses.
    • “Kaiser, which recorded results alongside its subsidiary Risant Health, recorded operating income of $1.4 billion last year, up from $569 million in 2024 as the nonprofit continued to invest in operational improvements, according to earnings results released last week. 
    • “Still, expenses rose by more than $11 billion last year as Kaiser said rising medication costs and other line items made providing care more expensive.”
  • Beckers Hospital Reviews identifies eleven rapidly growing health systems.
  • BioPharma Dive relates,
    • “Eli Lilly will acquire biotechnology startup Orna Therapeutics, saying Monday it will pay up to $2.4 billion to buy the privately owned company and a technology able to reprogram immune cells within the body.
    • “The Indiana-based drugmaker didn’t disclose how much upfront cash it’s shelling out for Orna, which specializes in “circular” RNA medicines that are believed to be more stable and easier to pair with the lipid nanoparticles used for delivery. But it noted in its statement that it intends to use Orna’s technology to develop cell therapies for autoimmune conditions.
    • “In announcing the deal, Lilly cited its interest in Orna’s lead project, which instructs immune cells to latch onto B cells that are attacking patients’ tissue in inflammatory diseases. The company presented data from preclinical studies at the American Society for Hematologymeeting in December that it’s using to support advancing into Phase 1 studies.”
  • and
    • “Japan’s largest drug company is teaming up with an artificial intelligence specialist to find new medicines for cancer and other diseases, through a deal that could be worth more than $1.7 billion.
    • “Announced Monday, the multiyear collaboration grants Takeda Pharmaceutical access to two technologies at Iambic Therapeutics. The first is an AI-driven platform used to discover and develop new drugs. The second is a model meant to predict how proteins will interact with certain receptors.
    • “The companies haven’t disclosed the deal’s upfront cost, nor any specific disease targets. The focus, though, will be on small molecule drugs for cancers and conditions rooted in the digestive or immune systems. Iambic will get milestone payments based on the partnership’s level of success, and is also eligible to receive royalties on net sales of any products it generates.”
  • Per Beckers Payer Issues,
    • “Patients who take advantage of zero-cost preventive screenings see better health outcomes and reduced spending, according to January research from BCBS Association and Blue Health Intelligence.
    • “The groups reviewed claims data of BCBS members with breast or colorectal cancer. The research pointed to lower likelihood of invasive tests and treatment.
    • “Eighty-one percent of members who were diagnosed with colorectal cancer through a preventive screening were classified in an early stage, compared to a 73% rate overall. For breast cancer, that figure was 86% during preventive screening. The early-stage rate was 82% overall.” 
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.”

Thursday report

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

From Washington, DC

  • Govexec reports,
    • “The House Oversight and Reform Committee on Wednesday unanimously advanced legislation aimed at updating the federal government’s buyout programs to encourage employees to leave.
    • “Voluntary Separation Incentive Payments are one of the government’s main tools for reducing agency headcounts, alongside Voluntary Early Retirement Authority and reductions in force. But VSIP offerings max out at $25,000, where the cap has sat since the 1990s.
    • “The Federal Workforce Early Separation Incentives Act (H.R. 7256), introduced by Rep. Nick Langworthy, R-N.Y., would remove the $25,000 hard cap on VSIP payments and replace it with a maximum of six months of a federal worker’s salary, subject to agency head approval. The new model is based off how federal agencies already calculate severance pay for laid-off feds.
    • ‘Langworthy said an update to the federal government’s buyout program was long-overdue, and that the changes will allow agencies to move more agilely—and humanely—in workforce planning.”
  • The Wall Street Journal relates,
    • “The Trump administration is planning to make it easier to discipline—and potentially fire—career officials in senior positions across the government, a move that would affect roughly 50,000 federal workers. 
    • “The U.S. Office of Personnel Management, which oversees the federal workforce, issued a final rule on Thursday that creates a category of worker for high-ranking career employees whose work focuses on executing the administration’s policies. Workers who fall into that category would no longer be subject to rules that for decades have set a high bar for firing federal employees.
    • “While political appointees at agencies are considered at-will employees who serve at the discretion of the president, career employees have long enjoyed strong job protections, including the ability to appeal firings, suspensions, or disciplinary action to an independent board. Workers that fall under the new category wouldn’t be able to appeal to the board.”
  • An OPM news release adds,
    • “The final rule was published for public inspection in the Federal Register on February 5, 2026, and will take effect 30 days after publication. Following the rule’s effective date, specific positions may be placed in Schedule Policy/Career by presidential executive order. Read Director Kupor’s blog post on the rule here.”
  • Tammy Flanagan, writing in Govexec, points out “the federal leave options employees can use when annual and sick time run out.”
    • “From unpaid leave to parental and military leave, federal workers have multiple options for time off under specific circumstances.”
  • STAT News informs us,
    • “President Trump on Thursday night is planning to announce the launch of TrumpRx, the website that he and his aides have touted for months as a platform aimed at lowering prescription drug prices. 
    • “The website, which uses technology from health care company GoodRx, is expected to display the cash prices — that is, the prices available when paying without insurance — for certain drugs and direct patients to other sites where they can buy the therapies. It’s part of Trump’s plan to lower drug prices in the U.S., but some experts are skeptical the platform will meaningfully affect affordability.” * * *
    • “TrumpRx will not sell medications. It is expected to be a searchable website that links to other sites through which patients can directly buy brand drugs. That might be a drug company’s own website, such as Eli Lilly’s LillyDirect or Novo Nordisk’s NovoCare Pharmacy, or an online pharmacy that partners with a drugmaker, such as Amazon Pharmacy and Truepill.”
  • The American Hospital Association News notes,
    • “The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology announced the selection of nine pilots as part of the Behavioral Health Information Technology Initiative to help improve behavioral health data exchange across care settings. The BHIT Initiative is a $20 million effort led by ASTP/ONC in coordination with the Substance Abuse and Mental Health Services Administration to support standard data elements and foster data exchange. The pilots, which will be completed by the end of this year, will be used to inform future standards, technical specifications, guidance and policy considerations. The pilots span across 45 exchange partners and eight states and Washington, D.C. The states are Colorado, Connecticut, Delaware, Florida, Massachusetts, North Carolina, Oregon and Rhode Island.”
  • Healthcare Dive calls our attention to the fact
    • “More than one-fourth of doctors enrolled in Medicaid didn’t actually deliver care to any Medicaid beneficiaries in 2021, according to new research adding to worries about low physician participation in the safety-net insurance program.
    • “Almost 28% of doctors enrolled in Medicaid were “ghost providers” and didn’t treat a single patient that year, the study published in Health Affairs on Monday found. Another 10% treated fewer than 10 patients, while the remaining 62.2% were standard or “core” providers treating the brunt of Medicaid enrollees.
    • “Participation varied widely by specialty, with psychiatrists most likely to be ghost providers and primary care physicians and cardiologists least likely to be ghost providers, the study found.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The nation’s top drug regulator said he wants to do away with pharmaceutical ads that employ “dancing patients, glowing smiles, and catchy jingles that drown out the fine print.” On Super Bowl Sunday, the drug industry will treat him to lounging football stars, a shouting DJ Khaled, and the soothing tones of Enya.
    • “Sunday’s game, the annual zenith of American advertising, is the first since Food and Drug Administration Commissioner Marty Makary began a self-described “crackdown” on drug marketing last year. And, based on the ads released in advance, little has changed in the eyes of the industry.” 
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources. Companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. In the past, companies were generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise.
    • “The agency sent a letter to industry providing notice of the FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Chronic exposure to pollution from wildfires has been linked to tens of thousands of deaths annually in the United States, according to a new study. 
    • “The paper, published Wednesday in the journal Science Advances, found that from 2006 to 2020, long-term exposure to tiny particulates from wildfire smoke contributed to an average of 24,100 deaths a year in the lower 48 states.
    • “Our message is: Wildfire smoke is very dangerous. It is an increasing threat to human health,” said Yaguang Wei, a study author and assistant professor in the department of environmental medicine at Icahn School of Medicine at Mount Sinai. 
    • “Other scientists who have studied the death toll from wildfire smoke were not surprised by the findings. 
    • “The estimates they’re coming up with are reasonable,” said Michael Jerrett, professor of environmental health science at the University of California, Los Angeles who was not involved in the study. “We need more of them. It’s only if we’re doing multiple studies with many different designs that we gain scientific confidence of our outcomes.”
  • Bloomberg Law tells us,
    • “Chris Womack is one of a dwindling number of Texas ranchers who can remember fighting the New World screwworm, a once-vanquished pest threatening to make an unwanted encore in the US after its recent return to northern Mexico. 
    • “You never forget the smell,” Womack, 60, said of his first encounter with a calf being devoured by screwworm maggots. It was one of many he and his father would treat in the early 1970s as an outbreak of the parasite — which can kill cattle in less than two weeks — devastated Texas ranchers.
    • “More than 50 years later, Womack and other Texas cattlemen are bracing for the screwworm’s potential comeback. Cases are proliferating in a Mexican state that borders Texas, with the pest having escaped containment by an international eradication program that banished it for decades. Texas Governor Greg Abbott issued a disaster declaration last week to open up state resources for the screwworm response.
    • “The pest’s resurgence would squeeze the $130 billion US cattle industry, which is already struggling with a record-low herd and rising costs. The screwworm prompted the US to ban cattle imports from Mexico for much of the last 14 months, crimping American beef producers at a time when record prices for the meat are adding to the pressure on shoppers angry about the cost of food.”
  • MedPage Today lets us know,
    • “New research challenged the longstanding belief that autism is much more common in males versus females.
    • “In a Swedish study of 2.7 million people, male-to-female ratios in autism diagnoses were nearly equal by age 20.
    • “Diagnosis rates peaked earlier for males, but females experienced a significant catch-up in adolescence.”
  • Genetic Engineering and BioTechnology News relates,
    • “Some types of CD8+ T cells (killer T cells) may play a role in the development of multiple sclerosis (MS). This is according to data from a new study published in Nature Immunology. Specifically, scientists found specific T cells that are abundant in people with MS, which also target the Epstein-Barr virus (EBV). They suggest that this points to a possible role for the virus in triggering the immune response seen in the autoimmune disease.   
    • “Full details are published in a paper titled “Antigen specificity of clonally enriched CD8+ T cells in multiple sclerosis.” For Joe Sabatino, MD, PhD, senior author on the study and an assistant professor of neurology at University of California, San Francisco’s Weill Institute for Neurosciences, “these understudied CD8+ T cells [connect] a lot of different dots.” That is because scientists have known for several years that EBV, a common virus carried by about 95 percent of adults, is present in virtually everyone who develops MS. This data “gives us a new window on how EBV is likely contributing to this disease,” he said.” 
  • Per BioPharma Dive,
    • “Bayer’s experimental blood thinner asundexian cut the relative likelihood of a repeat stroke by 26% without increasing the risk of internal bleeding, the company said Thursday, boosting hopes that the company might become a new option for “secondary treatment” of the disorder.
    • “The news could also elevate the outlook for medicines like asundexian, which are called Factor XIa inhibitors and are being advanced by a handful of the world’s largest pharmaceutical companies.
    • “Members of that drug class, including asundexian and a similar therapy from Bristol Myers Squibb and Johnson & Johnson, have previously suffered clinical setbacks in different types of cardiovascular illnesses. But asundexian’s success, first announced in November, lifted Bayer shares and indicated the drugs might be able to fulfill at least some of their commercial potential.
    • “The German drugmaker released full data from its positive study, “Oceanic-Stroke,” at the International Stroke Conference in New Orleans on Thursday.” 
  • Per the AP,
    • “A new kind of pill sharply reduced artery-clogging cholesterol in people who remain at high risk of heart attacks despite taking statins, researchers reported Wednesday.
    • “It’s still experimental but the pill helps rid the body of cholesterol in a way that today can be done only with injected medicines. If approved by the Food and Drug Administration, the pill, named enlicitide, could offer an easier-to-use option for millions of people.
    • “Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even taking the highest doses, many people need additional help lowering their LDL, or “bad,” cholesterol enough to meet medical guidelines.
    • “In a major study, more than 2,900 high-risk patients were randomly assigned to add a daily enlicitide pill or a dummy drug to their standard treatment. The enlicitide users saw their LDL cholesterol drop by as much as 60% over six months, researchers reported in the New England Journal of Medicine.”

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

  • Healthcare Dive reports,
    • “Cigna posted fourth quarter 2025 results Thursday morning that outperformed analysts’ consensus expectations, with adjusted revenue of $72.5 billion up more than 10% and adjusted operational income of $2.1 billion up 16%.
    • “Cigna Healthcare, the company’s insurance division, saw its revenue drop 16% in the quarter due to the sale of its Medicare Advantage business to Health Care Service Corporation. Cigna Healthcare’s operational income rose 44% year over year, however, after the company jacked up premiums for its stop-loss products after seeing those costs spike in the fourth quarter of 2024.
    • “But the lion’s share of attention on Thursday morning’s call was devoted to Express Scripts, and how the FTC settlement might impact the massive PBM’s profits.
    • “Short answer? It won’t, executives said.”
  • BioPharma Dive relates
    • “Hims & Hers Health is launching a copycat form of Novo Nordisk’s newly launched obesity pill, ushering in the latest contentious battle between the makers of branded weight loss medications and their drug-compounding counterparts. 
    • “Hims said Thursday that it’s now enabling healthcare providers to prescribe a compounded pill with the same active ingredient, semaglutide, as Novo Nordisk’s oral Wegovy. That treatment will be sold as part of treatment plans that begin at $49 for the first month — $100 lower than the price Novo is charging under a deal with the Trump administration. Hims also claimed that its treatment is formulated differently and involves a different delivery method to protect the active ingredient during digestion. 
    • “In a statement issued in response to Hims’ announcement, Novo spokesperson Ambre James-Brown called Hims’ move “illegal mass compounding and deceptive advertising” and threatened litigation. The compounder is “unlawfully” mass-marketing an “unapproved, inauthentic, and untested knockoff” of Novo’s medication, she said.” 
  • Modern Healthcare tells us,
    • “Adtalem Global Education has become Covista, the Chicago-based education company said, with a plan to expand its healthcare career network.
    • “Covista serves nearly 100,000 students and has a community of 385,000 alumni across its five accredited institutions.
    • “Covista touts it puts 24,000 new professionals annually into the healthcare workforce — more than any other U.S. institution — including 10% of America’s new nurses.”
  • Beckers Payer Issues lets us know,
    • “Participating Medicare Part D plans can officially begin covering weight-loss treatment in 2027. 
    • “The initiative falls under CMS’ voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth” — or BALANCE — model. The December news followed President Trump’s negotiations with Eli Lilly and Novo Nordisk to secure most-favored-nation pricing for drugs that treat obesity, diabetes and related conditions.
    • “To better understand Medicare usage and spending shifts, KFF analyzed CMS data from 2019 through 2024 [as discussed in the article].
  • and
    • “Here are 12 payer tools that achieved “Best in KLAS” recognition for 2026:
      • “Care management solutions: Cognizant (TriZetto CareAdvance Enterprise) 
      • “Claims & administration platforms: Cognizant (TriZetto Core Claims/Administration Solutions)
      • “CMS payer interoperability: Edifecs (XEngine Server for FHIR)
      • “Data analytics platforms: Innovaccer (Healthcare Data Platform)
      • “Payer/provider data exchange: Moxe (Digital ROI)
      • “Post-payment accuracy & integrity solutions: Trend Health Partners (TRENDConnect) 
      • “Pre-payment accuracy & integrity solutions: HealthEdge (Source)
      • ‘Quality measurement & reporting: Inovalon (Converged Quality) 
      • “Risk adjustment (coding, retrieval & compliance solutions): Datavant (Risk Adjustment Suite)
      • “Risk adjustment (POC & in-home health assessments): Cozeva (PayerOne Risk)
      • “IT consulting services: Huron
      • “Employer-sponsored healthcare services: Premise Health
    • “The full report is accessible from KLAS Research here.“
  • Per Beckers Hospital Review,
    • “Chicago-based CommonSpirit Health now has 242 artificial intelligence applications live across its hospitals, up from 230 last year.
    • “We are expanding our use of AI across CommonSpirit by deploying new capabilities and scaling the most impactful of our existing tools,” CIO Daniel Barchi told Becker’s.
    • “In 2025, the health system generated more than $100 million in annual savings through its use of AI and robotic process automation tools across multiple areas of the organization. Mr. Barchi said the value generated in fiscal year 2026 is expected to exceed last year’s total.
    • “More important than the financial impact is the expanded clinical and operational value we are seeing from these tools — value that is not measured only in dollars,” he said. “Our sepsis surveillance tool has contributed to continued reductions in sepsis-related mortality. Screening tools for colon and breast cancer are helping us identify high-risk patients, leading to thousands of additional screenings. AI tools for imaging are reducing scan times by up to 50%, supporting a better experience for patients and providers.”
    • “As CommonSpirit expands its AI footprint, Mr. Barchi said the health system has also declined or scaled back AI tools that failed to deliver expected value.”

Midweek report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Senate negotiators said an effort to renew expired healthcare subsidies had effectively collapsed, likely ending the hopes of 20 million Americans that the tax-credit expansion could be revived and lower their monthly insurance premiums.
    • “Talks had centered on a proposal from Sens. Bernie Moreno (R., Ohio) and Susan Collins (R., Maine) to extend a version of the enlarged Affordable Care Act subsidies for at least two years, while cutting off higher-income people from participating and eventually giving enrollees the option of putting money into health savings accounts. It also would eliminate zero-dollar premium plans. But lawmakers from both parties now say the chances of a deal have all but evaporated.
    • “It’s effectively over,” Moreno said Wednesday. Sen. Bill Cassidy (R., La.)—the architect of an adjacent plan—agreed. While Collins declined to be as definitive, she did say that it was “certainly difficult.”
  • Federal News Network tells us,
    • “Following a year of the Trump administration’s overhauls to the civil service, a bicameral group of lawmakers on Wednesday launched a congressional caucus focused on the federal workforce.
    • “Sens. Chris Van Hollen (D-Md.) and Tim Kaine (D-Va.), along with Reps. James Walkinshaw (D-Va.), Steny Hoyer (D-Md.) and Suhas Subramanyam (D-Va.) joined federal unions and good government organizations to announce the newly formed Federal Workforce Caucus. The group aims to more cohesively advocate for federal employees.” * * *
    • “Members of the new Federal Workforce Caucus, which includes at least some bipartisan support, are expected to meet regularly with leaders from federal unions, employee groups and other organizations. The group plans to propose legislation and workforce policies focused on long-term improvements to the career civil service.
    • “The Partnership for Public Service, American Federation of Government Employees, National Federation of Federal Employees and National Active and Retired Federal Employees Association, among several others, are also partners in the new caucus.”
  • OPM Director Scott Kupor has added another post to his Secrets of OPM blog.
  • Per a CMS news release,
    • “CMS continues to bring accountable care to more people with Medicare in 2026, expanding the benefits of high-quality, whole-person health care to achieve better health outcomes for millions of older Americans.
    • “As of January 2026, 14.3 million Medicare beneficiaries are estimated to receive care coordinated by Accountable Care Organizations (ACOs), up from 13.7 million in 2025, representing a 4.4% increase. This includes patients whose health care providers are in Medicare Shared Savings Program (Shared Savings Program) ACOs and entities participating in Center for Medicare and Medicaid Innovation (CMS Innovation Center) accountable care models, as well as other CMS Innovation Center models focused on total cost of care, advanced primary care, and specialty care.
    • “ACOs are groups of doctors, hospitals, and other health care providers who collaborate and provide coordinated, high-quality care to people with Medicare, and they are a critical tool to help Make America Healthy Again by supporting whole person care that addresses prevention, chronic illness and the root causes of disease.
    • “In addition to improving health care, ACOs save billions of dollars for the Medicare program by focusing on delivering the right care at the right time while avoiding unnecessary services and medical errors. ACOs achieve savings because health care providers are held accountable for saving money and improving health care quality, delivering a win for both patients and the Medicare Trust Funds.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of serious injuries.
    • “The Food and Drug Administration, which published an early alertabout the devices on Tuesday, said sensor values in Impella RP heart pumps may drift over time.
    • “Erroneous information on automated Impella controllers has caused users to make inaccurate adjustments to the devices and unnecessary pump exchanges, the FDA said.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels. The FDA said patients with impacted sensors should immediately discontinue use and dispose of any affected products. Abbott has reported 860 serious injuries and seven deaths associated with the issue since Jan. 7.” 
  • USA Today relates,
    • “A shortage in estrogen patches because of manufacturing issues and some brand discontinuation has been exacerbated by an increase in prescriptions for estrogen since the Food and Drug Administration removed its black-box warning label last fall. The shortage has left women exhausted, frustrated and scrambling each month to call pharmacies for the medicine they need to treat their menopause symptoms.
    • Some women have switched from generic medication to available brand names, which costs them as much as $300 a month and are not covered by insurance. Others have been forced to use a different brand of estrogen each month, leading to inconsistent care. Women have driven 45 miles to pick up a coveted box of the tiny plastic patch they place near their belly button and change twice a week to help with their symptoms, from frozen shoulders to vaginal dryness.”
  • STAT News adds,
    • “Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.
    • “More than two years after its approval, only about 60 patients across the U.S., Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

From the judicial front,

  • Healthcare Dive reports,
    • “The Federal Trade Commission has agreed to what it called a “landmark” settlement with Express Scripts, allowing the company to bow out of the agency’s lawsuit against major pharmacy benefit managers for allegedly inflating the cost of U.S. insulin.
    • “In return, Express Scripts, which is owned by Cigna and is one of the largest PBMs in the country, has agreed to make major changes to its drug benefit designs, including no longer preferring drugs with high list prices on its standard formularies when there are cheaper equivalents and delinking its compensation from the savings it negotiates with drugmakers, the FTC announced Wednesday.
    • “Express Scripts has also agreed to increase transparency, including reporting more data on drug spending and disclosing any kickbacks to brokers that help employers choose PBMs.
    • “Notably, the company also agreed to reshore its group purchasing organization Ascent from Switzerland back to the U.S.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The measles outbreak in South Carolina has increased to 876 cases, the state’s Department of Public Health reported Feb. 3. Last week, the South Carolina outbreak surpassed last year’s outbreak in Texas, which had 762 cases. The agency said the number of public exposure sites indicates community spread is occurring, increasing the risk of exposure and infection for individuals who are not immune due to vaccination or natural infection. “Vaccination continues to be the best way to prevent measles and stop this outbreak,” the department said.” 
  • MedPage Today informs us,
    • “In this self-controlled case series, myocardial infarction rates were nearly 9 times greater in the week after an RSV-related hospitalization compared with a control period prior to infection.
    • “Stroke rates were more than 7 times higher compared with the control period.
    • “Recent research has suggested that RSV vaccination lowers the risk of cardiorespiratory hospitalizations.”
  • and
    • The effectiveness of last season’s COVID vaccines among immunocompetent adults reached 40% against hospitalization and 79% against invasive mechanical ventilation or death.
    • Those levels of protection were similar among seniors and sustained through 6 months post-vaccination.
    • This study is a reminder that “vaccines still have a role, even in the current epidemiological landscape,” an expert said.
  • Per an NIH news release,
    • The National Institutes of Health (NIH) has opened the East Palestine Train Derailment Health Research Program Office to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio. The new office is the hub of a five-year, $10 million research initiative funded by NIH.
    • “Federal research experts will engage directly with the community, coordinate studies, and help enroll residents in federally supported health research through the new office.” * * *
    • Three years ago, on Feb. 3, 2023, a Norfolk Southern freight train derailment involving 38 railcars carrying hazardous chemicals — including vinyl chloride, butyl acrylate, ethylene glycol and benzene residue — resulted in prolonged fires and controlled burns in East Palestine. Several railcars burned for more than two days, and emergency responders conducted controlled burns that raised concerns about the potential airborne release of hydrogen chloride and phosgene.
    • “Local residents reported a range of initial health symptoms, including headaches and respiratory, skin and eye irritation. These reports prompted concerns about potential longer-term effects on maternal and child health, as well as psychological, immunological, respiratory and cardiovascular health.”
    • “This research program is designed to bring rigorous, independent science directly to the community,” said NIH Director Jay Bhattacharya. “By establishing a local presence, we can better engage residents, support enrollment in studies, and ensure the research reflects the real experiences and concerns of the people affected.”
  • Genetic Engineering and BioTechnology News observes,
    • “As drug‑resistant hospital infections continue to rise worldwide, a team of Australian researchers has identified a surprising new bacterial vulnerability: a sugar that only microbes make. By designing antibodies that recognize this sugar, the scientists were able to clear lethal infections in mice—offering a potential new strategy for tackling multidrug‑resistant pathogens.
    • “The work, published in Nature Chemical Biology, describes the development of monoclonal antibodies that target pseudaminic acid, a carbohydrate found on the surface of many dangerous bacteria but absent from human cells. The study, titled “Uncovering bacterial pseudaminylation with pan‑specific antibody tools,” demonstrates that this sugar may serve as a highly selective molecular flag for immunotherapy.”
  • Per Healio,
    • “Once-weekly subcutaneous tirzepatide may not raise risk for depression compared with placebo, according to a post hoc analysis of the SURMOUNT trials.
    • “As Healio previously reported, in January the FDA requested that risk for suicidal ideation and behaviors be removed from labels for liraglutide (Saxenda, Novo Nordisk), injectable semaglutide 2.4 mg (Wegovy, Novo Nordisk) and tirzepatide (Zepbound, Eli Lilly). 
    • “In data published in Obesity, researchers found adults receiving tirzepatide in three SURMOUNT trials did not experience worsening of depression throughout the studies.
    • “The low occurrence of these events with tirzepatide is similar to that observed in pooled analyses of semaglutide 2.4 mg and liraglutide 3 mg, both GLP-1 receptor agonists approved for weight management,” Thomas A. Wadden, PhD, professor of psychology in psychiatry at Perelman School of Medicine, University of Pennsylvania in Philadelphia, told Healio. “The present report provides the first detailed analysis of the risk of these psychiatric events with tirzepatide.”

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

  • BioPharma Dive reports,
    • “Eli Lilly shares jumped early Wednesday after the company reported better-than-expected fourth-quarter revenue and shared higher forecasts for 2026, buoyed by its obesity and diabetes medicines.
    • “Fourth-quarter revenue soared 43% to $19.3 billion, Lilly said Wednesday. That’s 7% above the Wall Street consensus, Leerink Partners analyst David Risinger wrote in a note to clients. Earnings per share beat estimates by 9% and operating income came in 13% higher than analysts expected, he said.
    • “This year, Lilly expects revenue of between $80 billion and $83 billion, with non-GAAP earnings of $33.50 to $35 a share. Analysts had been expecting midpoint forecasts of $78.5 billion for revenue and $33.30 for EPS, according to Risinger.”
  • Fierce Pharma tells us,
    • “Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.
    • “The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.”
  • MedTech Dive informs us,
    • “Boston Scientific has been one of the big winners of the pulsed field ablation revolution. Over the past two years, the company has reported strong electrophysiology sales growth — sometimes in the triple digits — and declared itself the clear market leader in PFA.
    • “However, on a Wednesday morning earnings call, analysts questioned executives on the electrophysiology unit’s potential after U.S. sales growth stalled in the fourth quarter compared with the third quarter.
    • “CEO Mike Mahoney told investors that the company remains confident in PFA’s potential, even as the market becomes more penetrated and competition in the space ramps up. Mahoney said that the electrophysiology market should grow about 15% in 2026, and the company expects to grow above that rate.
  • Beckers Clinical Leadership notes,
    • [Nurse] workforce projections from HHS’ Health Resources and Services Administration indicate “the gap between the demand for and supply of RN services is expected to shrink over the next decade from 10% in 2027 to 6% in 2037,” according to a January report from the council. 
    • “This forecast is partly due to an increase in first-time examinees of the National Council Licensure Examination, according to the report. 
    • “By comparison, the U.S. supply of licensed practical nurses and licensed vocational nurses is projected to decrease a whopping 36% by 2037, HRSA data shows. These workforces have declined in labor participation and absolute licensure statistics across most states, the report said. 
    • “Although the projected outlook for the RN workforce is more favorable than it is for LPNs/LVNs, maldistribution of providers remains a critical issue, with nonmetropolitan areas projected to face significantly higher shortages than metropolitan areas in the coming years,” the report said. “These issues exacerbate the broader projected shortfall owing to the dual trends of increasing demand due to an aging population and an aging workforce.”
  • Cardiovascular Business lets us know,
    • “Early adopters have been using robotics to perform cardiac surgeries in the United States for years now, but multiple factors—including high costs and early concerns about patient outcomes—have held back widespread implementation.   
    • “According to a new commentary in The Annals of Thoracic Surgery, however, robotic cardiac surgery has gained considerable momentum in the last year. Is now the time for this trend to truly take off?
    • “A convergence of improved training frameworks, maturing technology and increasingly standardized quality processes have supported a broader and more sustainable growth,” wrote co-authors Andrea Amabile, MD, a cardiothoracic surgery resident with the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute, and Johannes Bonatti, MD, director of the cardiac robotic surgery at the UPMC Heart and Vascular Institute. “In this context, the past year has brought forward a set of notable global milestones that collectively illustrate the evolving capabilities of robotic cardiac surgery.”
  • Per Beckers Health IT,
    • “KLAS Research released its annual “Best in KLAS” report Feb. 4, ranking healthcare technology vendors and service providers across more than 140 market segments based on feedback from the clinicians and administrators who use them.
    • “The report, now in its 28th year, draws on tens of thousands of provider evaluations to identify the top-performing solutions in categories spanning electronic health records, revenue cycle, cybersecurity, AI and other areas. This year’s edition arrives as AI — particularly ambient speech technology — continues to reshape clinical workflows, and as health systems navigate tightening finances alongside growing vendor competition.
    • “For the 16th consecutive year, Epic was named the top Overall Health System Suite. Epic also won Best in KLAS recognition in 11 market segments.
    • [The article lists] the winners in some of the report’s most closely watched categories. The full report is accessible from KLAS Research here.
  • Per Beckers Payer Issues,
    • “Optum has launched a pair of AI-driven prior authorization products, one designed to speed up submissions on the provider side and another to accelerate clinical reviews for payers.
    • “The provider-facing product, Digital Auth Complete, went live in January in collaboration with digital health company Humata Health. The payer-facing product, InterQual Auth Accelerator, began piloting with two large health plans in late 2025, with the first payer expected to be fully live by April.
    • “It’s a combination of three things,” John Kontor, MD, senior vice president of clinical technology at Optum Insight, told Becker’s, explaining why the products are coming to market now. “It is the policy changes, including CMS-0057, that have accelerated everyone’s urgency to get this figured out. Two, it’s the readiness now of technology to be able to support solving many of these administrative, burdensome problems in healthcare. And third, the policy changes really reflect both industry frustration and impatience and the public’s real desire to get real and better answers to the problems of prior authorization.”
  • Per Fierce Healthcare,
    • “Epic is rapidly building out artificial intelligence tools integrated into its electronic health record solution as health IT companies strive to keep up with the dizzying speed of AI innovation.
    • “This week, the EHR giant released AI Charting, a built-in feature that ambiently listens during patient visits and drafts the clinician’s note. The AI charting feature also queues up orders based on the conversation. 
    • “Epic CEO Judy Faulkner announced the AI Charting technology during the company’s Users Group Meeting (UGM) in August as part of its collaboration with longtime partner Microsoft.
    • “AI models are advancing at a rapid pace; we continue to work with Microsoft on AI Charting and use a variety of different models through the Microsoft Azure platform,” an Epic spokesperson said Wednesday.”

Monday report

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump demanded Monday that House lawmakers back the bipartisan spending deal passed by the Senate last week and set aside policy demands in an effort to quickly end a partial government shutdown. 
    • “We need to get the Government open, and I hope all Republicans and Democrats will join me in supporting this Bill, and send it to my desk WITHOUT DELAY,” Trump posted on Truth Social. “There can be NO CHANGES at this time.”
    • “House Speaker Mike Johnson (R., La.) is trying to pass as soon as Tuesday the $1.2 trillion package that funds large parts of the federal government through the end of the fiscal year while funding the Department of Homeland Security for just two weeks. That short-term extension is designed to provide time for a bipartisan deal to be reached on stricter policies for immigration-enforcement agents.” 
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services today announced a new behavioral health initiativeto assist homeless individuals with substance use treatment and recovery. The program, called the Safety Through Recovery, Engagement, and Evidence-based Treatment and Supports, or STREETS, will focus on psychiatric care, medical stabilization and crisis intervention, HHS said. The initiative is tied to an executive order issued by the administration last week on substance use.” 
  • In January 2024 OPM proposed to create to advance the FEHB / PSHB eligibility date to the first day of employment.  AFHO, the trade association that the FEHBlog represents, used the public comment period to advocate for the HIPAA 820.  Today, in a welcome deregulatory step, OPM withdrew the proposed rule.
  • MedCity News considers whether “It is Time to Change the Independent Dispute Resolution Process of the No Surprises Act.” The FEHBlog thinks so because the current process is opaque.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said Thursday.
    • “The premarket approval filing for Grail’s Galleri test focuses on a U.S. study of more than 25,000 people and a randomized, controlled trial the company is running in the United Kingdom.
    • “Grail President Josh Ofman said at an event in January that approval will be a “major trigger” for evidence-based decisions with U.S. payers and could enable Medicare coverage.”
  • Cardiovascular Business relates,
    • “eMurmur, an Ontario-based artificial intelligence (AI) startup, has received U.S. Food and Drug Administration (FDA)clearance for its suite of algorithms designed to evaluate heart recordings captured by digital stethoscopes. 
    • “The newly approved offering, eMurmur Heart AI, was designed to detect both the presence and absence of heart murmurs. In addition, it can provide hemodynamic data that helps care teams as they develop patient management strategies. eMurmur Heart AI can be accessed through the company’s own standalone software—available as a web platform or mobile app—or through a third-party system.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “The Centers for Disease Control and Prevention released its annual progress report on health care-associated infections Jan. 29, which found continued decreases in hospitalizations from multiple infections last year. Among the findings, there was an 11% decrease in hospital-onset Clostridioides difficile, or C. difficile, infection; a 10% decrease in catheter-associated urinary tract infections, or CAUTI; a 9% decrease in central line-associated bloodstream infections, or CLABSI; and a 7% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA. 
    • “Among inpatient rehabilitation facilities, there was an 18% decrease in hospital-onset C. difficile infections and an 8% decrease in CAUTI. For long-term care hospitals, there was a 23% decrease in ventilator-associated events and a 15% decrease in hospital-onset C. difficile. The report recommended providers continue reinforcing prevention practices, review HAI surveillance data to identify areas for improvement and address any gaps in prevention practices.”
  • Cardiovasular Business relates,
    • “Researchers have developed a new injectable therapy that could help protect a patient’s brain after they experience a stroke. The team behind this new treatment shared a look at its early progress in Neurotherapeutics.
    • “The therapy in question was built to cross the blood-brain barrier and help repair brain tissue, limiting the risk of permanent brain damage and encouraging a healthy recovery following an ischemic stroke. Co-author Samuel Stupp, PhD, founding director of Northwestern University’s Center for Regenerative Nanomedicine, previously found that supramolecular therapeutic peptides (STPs) technology could reverse paralysis and repair tissue in mice after a single injection. This analysis took those observations related to the potential benefits of STPs and transferred them to a new area of medicine. 
    • “Current clinical approaches are entirely focused on blood flow restoration,” co-author Ayush Batra, MD, an associate professor with the Northwestern University Feinberg School of Medicine and co-director of the NeuroVascular Inflammation Laboratory at Northwestern, said in a statement. “Any treatment that facilitates neuronal recovery and minimizes injury would be very powerful, but that holy grail doesn’t yet exist. This study is promising because it’s leading us down a pathway to develop these technologies and therapeutics for this unmet need.”
  • MedPage Today informs us,
    • “Use of single maintenance and reliever therapy (SMART) for moderate-to-severe asthma saved money by improving outcomes, according to a meta-analysis.
    • “While SMART is recommended by guidelines, combination inhalers aren’t FDA approved for both rescue and maintenance therapy, and thus insurance coverage has been a struggle in the U.S.
    • “Finding an economic advantage should influence payer decisions, the researchers suggested, calling for broader formulary inclusion of SMART.”
  • and
    • “All hypertensive disorders of pregnancy were tied to increased long-term cardiovascular risk, but superimposed preeclampsia carried the highest risk.
    • “All subtypes were significantly associated with higher risks of heart failure and stroke, and most were associated with higher risk of cardiovascular death.
    • “Unspecified hypertension was associated with myocardial infarction, while chronic and unspecified hypertension were both associated with atrial fibrillation.”
  • The Endocrinology Advisor lets us know that “the fit-fat index (FFI), which calculates the ratio of cardiorespiratory fitness to various adiposity measures (BMI, WHR, or WHtR), is significantly associated with lower risks for cardiovascular and all-cause mortality.”
  • Genetic Engineering and BioTechnology News points out,
    • “Evidence has been rising over the past few years that the gut microbiome can significantly influence how well cancer treatments work, especially immunotherapies. But the underlying mechanism has remained unclear. Now, a new study reveals how bacteria in the gut can help determine whether the amino acid asparagine (obtained from diet) will increase tumor growth or activate immune cells against the cancer​.
    • “The findings, published in Cell Microbe and Host in the paper, “Microbiota utilization of intestinal amino acids modulates cancer progression and anticancer immunity,” could lead to a novel cancer treatment approach and monitoring strategy; instead of targeting tumors directly, clinicians may one day be able to reshape the gut microbiome or diet to starve tumors while supercharging immune cells.
    • “Our study suggests that we need to think about how the interplay of diet, gut microbiota and tumor-infiltrating immune cells could affect cancer growth and response to therapy. We can’t overlook this key level regulation,” said Chunjun Guo, PhD, associate professor of immunology at Weill Cornell.”
  • Per BioPharma Dive,
    • “Novo Nordisk’s experimental combination shot CagriSema helped people with diabetes and obesity lower their blood sugar and lose more weight than the blockbuster drug Wegovy in a Phase 3 trial, the company said Monday, building the case for regulatory approval.
    • “The results come from one of several studies Novo has underway in obesity and diabetes for CagriSema, which adds a second metabolic drug to the active ingredient from Wegovy in a fixed-dose injection. The Denmark-based drugmaker has already asked the Food and Drug Administration to approve the shot in obesity.
    • “The data could sharpen Novo’s rivalry with Eli Lilly and its obesity drug Zepbound, which has overtaken Wegovy to become the biggest-selling obesity treatment in the world. Looking at all participants enrolled in the trial, CagriSema’s weight loss and blood-sugar reductions fall numerically short of Zepbound’s, but a head-to-head trial comparing the two hasn’t been completed yet.”
  • and
    • “An experimental rare disease drug from Sanofi succeeded against one so-called lysosomal storage disorder but failed against another, the French pharmaceutical company said Monday.
    • “According to Sanofi, the drug, dubbed venglustat, missed its primary objective in a Phase 3 study testing it against Fabry disease. However, in another study in a form of Gaucher disease, the drug met its main goal and three out of four key secondary endpoints. Sanofi didn’t provide details — they’ll be shared at medical meeting this week — but said it intends to submit the Gaucher results to global regulatory authorities.”

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

  • MedCity News reports,
    • “Access to primary care is collapsing in the U.S., creating an opening for new models that lower costs and improve outcomes.
    • “This week, Premise Health and Crossover Health moved to capitalize on that opportunity, announcing an agreement to merge into a single company focused on scaling primary care access. The combined organization will provide onsite, nearsite and virtual care for more than 400 employers with millions of members, operating nearly 900 wellness centers across the country.
    • “The new entity will be led by Premise CEO Stu Clark. He framed the deal as a convergence of two companies with the same thesis: advanced primary care is the lever to disrupt U.S. healthcare. Both companies define advanced primary care as an integrated bundle of primary care, behavioral health, pharmacy services and care navigation.
    • “Crossover and Premise have proven that a few things happen when you deploy our advanced primary care models: access goes up, health improves and costs go down. Costs go down for the employer as well as for the family,” Clark stated.
    • “The company’s target customers will be large self-insured employers, mainly Fortune 1000 companies, unions, Native tribes and government entities, he said.”
  • Healthcare Dive relates,
    • “Tenet has regained full ownership of Conifer Health Solutions, acquiring the remaining stake in its revenue cycle management business from CommonSpirit Health.
    • “CommonSpirit will pay Tenet almost $1.9 billion over the next three years to get out of its existing services contract, according to the deal announced Monday. That’s offset by $540 million that Conifer will pay CommonSpirit for its almost 24% equity stake and to eliminate CommonSpirit’s capital account.
    • “All told, Tenet executives said the deal creates almost $2.7 billion in total value to the system through the cash payments, the reduction of liability on its balance sheet and the value of the additional Conifer equity. Tenet’s stock rose 2% in morning trade Monday following the news.”
  • Fierce Healthcare informs us,
    • “Community Health Systems (CHS) has wrapped a deal to divest its 80% interest in two joint ventures to Vanderbilt University Medical Center (VUMC), the organizations announced Monday morning.
    • “The joint ventures own and operate Tennova Healthcare – Clarksville, a 270-bed hospital with 1,100 staff, and other ancillary businesses in the major Tennessee city. CHS received $623 million before certain transaction expenses for the interests, with CHS also paying $23 million of owed balances to the subsidiaries upon completion of the transaction. 
    • “VUMC, in its announcement, said it will be renaming the hospital and a freestanding emergency room to Vanderbilt Clarksville Hospital and Vanderbilt Emergency Sango, respectively. It also highlighted physician practices in Clarksville plus nearby Dover, Pleasant View and Tiny Town that were included in the deal.”
  • and
    •  “Community Health Systems (CHS) has sold its Commonwealth Health system to nonprofit Tenor Health Foundation, the for-profit chain announced.
    • “The sale, effective Feb. 1, comes just days after the parties received regulatory clearance from the state and in the wake of community and government efforts to keep the facilities open despite financial losses (see that story below). 
    • “The announcement also makes public the three-hospital system’s price tag: $33 million of cash plus a $15 million promissory note from Tenor, with additional cash considerations possible depending on collections of certain patient accounts receivable during the following 90 days.”
  • Healthcare Dive adds,
    • “Healthcare bankruptcies declined in 2025, even as the sector faces financial headwinds on the horizon, according to an analysis published last week by restructuring advisory firm Gibbins Advisors.
    • “The industry recorded 45 bankruptcy filings for debtors with liabilities of at least $10 million last year, down 21% from 2024 — and a steep drop from the 79 cases logged in 2023. However, hospital bankruptcies rose. 
    • “Another year of falling Chapter 11 bankruptcy filings doesn’t necessarily signal financial health in the sector, the report cautioned. Healthcare remains under “significant pressure” as the industry faces looming challenges like historic cuts to Medicaid, according to Gibbins.” 
  • The New York Times tells us,
    • If you wind up at an urgent care center in America, it’s increasingly likely you will be treated by a P.A. For a long time, P.A. meant the same thing everywhere: “physician assistant,” a licensed medical professional who can perform patient care, including prescribing medicine, under the supervision of a doctor.
    • But that might be changing. In Oregon, New Hampshire and Maine, P.A. now means “physician associate,” and other states may follow this year.
    • “Assistant” versus “associate” might sound like a trivial semantic debate, but to many practitioners, and to the American Academy of Physician Associates (which changed its own name in 2021), it’s an important part of the expanding role of P.A.s in health care. * * *
    • “Since 2000, the number of P.A.s has quadrupled, while many parts of the country face a shortage of doctors. That means P.A.s are becoming more numerous — and visible — in all fields of medicine, from primary care to dermatology. And along with the name change, they are seeking the ability to operate more independently from doctors.”
  • Per The Wall Street Journal,
    • “Eli Lilly plans to open a $3.5 billion weight-loss drug manufacturing plant in Pennsylvania’s Lehigh Valley, creating 850 permanent jobs.
    • “Pennsylvania is investing $100 million in tax credits and grants for the project, plus $5 million for a pharmaceutical training center.
    • “Lehigh Valley manufacturing jobs have grown by 28.8% since 2010, triple the national rate, despite recent U.S. manufacturing job contractions.”
  • Per Beckers Health IT,
    • “Oracle Health is expanding its Clinical AI Agent to help clinicians automate the creation of clinical orders during patient appointments.
    • “The tool now supports automated order creation for laboratory tests, imaging and diagnostic studies, new and refilled prescription medications, follow-up appointments and referrals. Oracle Health said in a Feb. 2 news release that the update builds on the product’s existing note-generation feature and uses ambient listening during visits to draft clinical orders for physician review and approval.
    • “The technology is designed to reduce the administrative burden of repetitive manual tasks, such as order entry, which can pull providers away from direct patient care and contribute to burnout.”

Friday report

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

From Washington, DC

  • MedCity News offers four takeaways from yesterday’s House of Representatives hearings with health insurance CEOs.
    • Everyone agrees healthcare affordability is a problem.
    • Everyone has different ideas for addressing the affordability problem.
    • Vertical integration [bad per a bipartisan group of members of Congress]
    • Prior authorization and denials [bad per a bipartisan group of members of Congress]
  • Roll Call adds,
    • “The House left Thursday night after barely shooting down another war powers resolution and passing a last slate of funding bills, leaving it up to the Senate to avert a partial government shutdown by next week’s deadline.
    • “But with a major winter storm predicted to blanket Washington and other swaths of the country in double digits of snow this weekend, senators are already facing delays that make for tight timing. A spokesman for Senate Majority Leader John Thune, R-S.D., announced Friday that Senate votes originally slated for Monday would be postponed until 5:30 p.m. on Tuesday [due to the impending winter storm].”
  • The Wall Street Journal offers the Medicare-eligible community helpful information about Medicare Part B and D’s income adjustment premiums, which are known as IRRMA.
  • OPM Director Scott Kupor added to his Secrets of OPM blog with a post about improving claims administration for the complex federal employee retirement systems.
    • “Here’s the reality: OPM does not receive a fully completed application and cannot begin its work – on average – for about 120 days from when the applicant starts the application process.
    • “So, where are those 107,000 total [online retirement] applications [(ORA)} sitting today? 
    • Roughly half are at OPM (more on that later), but 30% are sitting with the payroll providers; 12% are sitting with agency HR teams, and 8% are sitting with the applicant.
    • That matters, because when cases do reach OPM, we move quickly. We are issuing interim pay immediately in about 75% of cases, and on average within seven days in 100% of cases. That means, on average,  within seven days of receiving the application, annuitants will be getting 80% of their expected final post-adjudication payout. Making sure retirees have money in their bank accounts as fast as possible is our first priority, and our performance there is strong.
    • And we are also seeing huge dividends from ORA in the time it takes for us to complete the final review of an annuitant’s case and deliver them 100% of their earned pension. As of today, we are completing ORA applications in less than 40 days from when we receive them in OPM. To give you a reference point, it takes at least twice as long for us to adjudicate paper-based cases. So, we are moving in the right direction.
    • But we are not complacent with the status quo and will continue to do even better.
  • FedWeek reports,
    • “The Postal Service has launched a new bid solicitation platform allowing businesses to submit proposals to access its last-mile delivery network, something Postmaster General David Steiner has touted as a key to turning around the service’s finances.
    • “Competitive bidding is now open for its 18,000 delivery destination units (DDUs) for same day or next day service, something that had become increasingly likely as contract renewal talks with Amazon stalled late last year – and with Amazon reportedly threatening to directly compete with it own, expanded, fleet.
    • “USPS officials said the move responds to growing demand for speed and convenience in the shipping market and to better leverage agency’s last-mile capabilities. Accepted bids are expected to be formalized through negotiated service agreements, with winning bidders notified in the second quarter of 2026 and service beginning in the third quarter.
    • ‘The news is bitter sweet for some postal carriers that have been wrestling Amazon packages to their final destinations for years, as any relief could be short lived and potentially result in the same volume but dealing with multiple carriers instead of one.”
  • The American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration has released a guide to improve coordination between 988 lifeline and 911 emergency services. It outlines strategies to reduce legal risk, clarify roles and strengthen partnerships to ensure appropriate care in crisis situations. The guide also includes resources to help achieve interoperability between the services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Sanofi said Friday it will ask regulators around the world to review its new eczema drug amlitelimab following mixed study results that could lead to a clearance in the U.S. but spell trouble in Europe.  
    • “A combination of amlitelimab and topical steroids helped between one-quarter and one-third of people with eczema completely or almost completely clear their skin lesions, depending on the dose frequency received and trial they’d participated in. Amlitelimab met all its objectives in one late-stage study. too. But in a second trial, amlitelimab missed a statistical threshold sought by European regulators. A safety study also uncovered one case of a type of skin cancer in a drug recipient.
    • ‘The results show amlitelimab is “a U.S. file-able drug that can differentiate on convenience,” Jefferies analyst Michael Leuchten wrote in a note to clients. Sanofi said it intends to move forward with global submissions based on the “totality of the data.”
  • MedTech Dive informs us,
    • “Integra LifeSciences has recalled wound and burn treatments over issues linked to 14 serious injuries, the Food and Drug Administration said Thursday.
    • “The FDA published an early alert after Integra wrote to customers about packaging failures that affected the sterile barrier and could lead to patient infection.
    • “Integra wrote to customers last week, around five months after recalling other wound and burn devices because of inadequate sealing of sterile barrier packaging.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “Jury selection in the federal murder trial of Luigi Mangione is scheduled to begin Sept. 8, U.S. District Judge Margaret Garnett said Jan. 23.
    • “The 27-year-old is accused of fatally shooting UnitedHealthcare CEO Brian Thompson outside the New York Hilton Midtown in late 2024. Mangione has pleaded not guilty to four federal charges, including murder through use of a firearm, as well as state murder charges.
    • “The next milestone in the federal case will depend on Judge Garnett’s decision on whether Mangione will face the death penalty, which Attorney General Pamela Bondi directed federal prosecutors to pursue in April. If Judge Garnett removes capital punishment as an option, the trial would begin Oct. 13; if she allows the case to proceed as a capital case, the trial would start in early 2027, according to reporting from The Guardian.“
  • MedPage Today points out,
    • “The American Psychiatric Association (APA) is suing a New York State health plan over its alleged use of “ghost networks” that list mental health providers that are not in their network or aren’t taking new patients.
    • “The class action lawsuit, filed on Dec. 30 in federal court against EmblemHealth, alleges that the ghost network directory “constitutes unlawful deceptive acts and practices, false advertising, and violations of statutory and regulatory requirements,” according to an APA press releaseopens in a new tab or window. “It also alleges that their provider directory violates federal trademark law by falsely advertising and misusing the names, identities and reputations of mental health clinicians.”

From the U.S. healthcare and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Among children 5–17 years, hospitalizations are stable and emergency department visits are increasing. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally but has decreased for three consecutive weeks. Among children 5–17 years, hospitalizations are stable and emergency department visits are increasing. Activity is increasing or stable in the Midwest, Central, and West Coast regions.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations among infants less than 1 year old are elevated.”
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds,
    • “The South Carolina Department of Public Health (DPH) today confirmed 54 new measles cases in just three days, raising the size of its outbreak, which DPH first reported in October, to 700 cases.
    • “The news comes as the Centers for Disease Control and Prevention (CDC) confirmed 416 total US cases so far this month—an increase of 245 infections in the past week—and as US health officials downplay the burgeoning outbreak and the key role that vaccines play in preventing illness.”
  • and
    • “Routine childhood vaccinations, nor the aluminum used as vaccine adjuvants, are not associated with an increased risk of epilepsy in young children, according to a new case-control study published this week in The Journal of Pediatrics. 
    • “The study, led by a team from the Marshfield Clinic Research Institute in Marshfield, Wisconsin, examined whether being up to date on recommended vaccines or having higher cumulative exposure to vaccine-related aluminum was linked to the development of epilepsy in children under age four. 
    • “Analyzing a decade of pediatric health data from the Vaccine Safety Datalink, which is a collaboration between the Centers for Disease Control and Prevention and several health care sites that monitor vaccine safety, the team identified 2,089 children diagnosed as having epilepsy from age 1 year to less than 4 years and matched them with 20,139 children without epilepsy based on age, sex, and health care site. 
    • “Most participants were boys (54%) and between the ages of 1 year and 23 months (69%). White non-Hispanics composed the largest ethnicity group in the study (40%).”
  • STAT News tells us,
    • “The number of ongoing prescription drug shortages rose slightly in the last quarter of 2025, but remained significantly lower than the all-time high reached in the beginning of 2024. Moreover, the number of new shortages identified last year marked the lowest level in nearly 20 years, according to a new report from the American Society of Health-System Pharmacists.
    • “As last year drew to a close, there were 216 prescription medicines in short supply in the U.S., which was slightly more than earlier in the year, but this was significantly less than the 323 prescription drug shortages recorded in the beginning of 2024, the report found.
    • “The number of new shortages identified last year was just 89, the lowest figure since 2006, and considerably less than 130 medicines that were in shortly supply in 2024. And notably, long-standing shortages are beginning to resolve; 75% of all the active shortages started in 2022 or later.”
  • Per MedPage Today,
    • “People with the lowest serum vitamin D levels were 33% more likely than those with the highest levels to be hospitalized for respiratory tract infections.
    • “Researchers found no evidence that the association between vitamin D status and respiratory tract infection risk differed by race or ethnicity.
    • “Obesity, being male, older age, statin use, and lower income were all linked to a greater risk of hospitalization for respiratory infections.”
  • and
    • “Arthritis can be disabling enough to prevent people from working, but the factors influencing employability in this population have not been well studied.
    • “This study used data from the long-running Health and Retirement Study to estimate “healthy working life expectancy” (HWLE) for people with arthritis, including major subgroups.
    • “HWLE was found to be markedly diminished for people with arthritis, and especially so for arthritis patients not finishing high school, those with obesity, and Black individuals.”

From the U.S. healthcare business front,

  • Fierce Pharma reports,
    • “With just a few months to go before Eli Lilly expects to launch its own oral GLP-1 obesity drug, Novo Nordisk is making the most of its head start with the Wegovy pill.
    • “In the second week of oral Wegovy’s launch, which ended Jan. 16, the pill logged roughly 18,400 total prescriptions, according to IMS data cited in a Friday note from analysts at Jefferies. Other tracking data put the second week of Wegovy pill prescriptions closer to 20,000, the analyst team pointed out.
    • “The quick uptake of Novo’s new oral obesity offering is impressive and appears “numerically higher” than both injectable Wegovy (roughly 1,600 prescriptions) and its Lilly counterpart Zepbound (around 7,300 prescriptions) in the first two weeks of their respective launches, the Jefferies team said.”
  • The FEHBlog ran across this Health Care Cost Institute website which “shows average price data for bundles of health services to help you better understand the cost of care in your area.” Check it out.
  • Fierce Healthcare informs us,
    • “CommonSpirit Health and Altru Health System are considering a deal to transfer three North Dakota hospitals to the latter, the organizations announced Thursday.
    • “The pair’s signed letter of intent outlines plans to evaluate a potential deal for the facilities, a process they said would run “the next several months” before a potential definitive agreement might be struck.
    • “In the balance are CHI St. Alexius Health Bismarck, a multispecialty acute care medical center in the state’s capital, and two smaller critical access hospitals, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison. All three are Catholic facilities within CommonSpirit’s regional healthcare system CHI St. Alexius Health.”
  • Beckers Hospital Review notes,
    • “Newly released data from KFF show there were an average of 422 emergency room visits per 1,000 population nationally in 2024, the most recent year for which data are available. KFF used  data from the American Hospital Association’s annual survey of community hospitals  — which accounts for 85% of all U.S. hospitals — and population estimates from the Census Bureau to compile ED visits per 100,000 population for every state.
    • “ED utilization rose in many states compared to data from 2023. The latest figures offer a preview of where added strain from rising coverage losses and reduced access to preventive care may hit hardest. 
    • “[The article includes] a state-by-state breakdown of total emergency department visits per 1,000 population in 2024, including the District of Columbia, starting with states where rates are highest.” 
  • Beckers Health IT lets us know,
    • “Walmart is set to open four clinical research sites in spring 2026, including at its former healthcare centers.
    • “The Walmart Healthcare Research Institute is launching the facilities in collaboration with clinical research company Care Access at three ex-Walmart Health locations and a rural Walmart store. The sites will offer health screenings and explore study opportunities with patients.
    • “Clinical research should feel practical and approachable, not distant or intimidating, especially for communities that have had difficulty participating in opportunities for innovative treatments,” Walmart Chief Medical Officer Emily Aaronson, MD, said in a Jan. 22 news release.”

Thursday report

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

From Washington, DC

  • Healthcare Dive reports,
    • “Republicans and Democrats in the House Budget Committee spent Wednesday blaming each other for the steep cost of healthcare, and arguing for diametrically opposed ideas to lower it. However, a few areas of bipartisan agreement emerged, including targeting healthcare consolidation — once an unheard-of view for members of the GOP.
    • “We got problems in Peoria with consolidation, with too much power and too many assets in too few market participants,” said Chairman Jodey Arrington, R-Texas, referring to a small community in Hill County. “You know how we feel about big government … but the most important thing here is, I think there’s common ground here.”
    • “We ought to huddle up at some point, probably not during a hearing, and figure out where we can deal with big medicine monopolies in pharma, hospital, insurance — the whole gambit. And I just want you to know I’m down with that,” Arrington continued.”
  • AHIP released two more healthcare cost articles today.
  • The Hill reports,
    • “Some of the nation’s top health insurance executives sought to deflect blame for the soaring cost of health care in the U.S., arguing that rising hospital and prescription drug prices were driving premiums higher and making health care less affordable for Americans.
    • “The CEOs of five major health insurers testified before a House Energy and Commerce subcommittee on Thursday, the first in a series of back-to-back hearings focused on finding the root causes driving unaffordability in the health care system, including skyrocketing premiums.”
  • and
    • “The House passed its final four appropriations bills Thursday afternoon, bringing Congress one step closer to avoiding a partial shutdown at the end of the month.
    • “A minibus package passed with a convincing 341-88 vote, funding the departments of Defense, Transportation, Housing and Urban Development, Health and Human Services, Labor, Education and other related agencies. The House separately passed legislation to fund the Department of Homeland Security with a 220-207 vote.”
  • The House of Representatives will be on recess next week while the Senate returns to Capitol Hill to tackle these appropriations bills.
  • Beckers Payer Issues raises three big questions about Trump’s healthcare policy plan.
  • On the bright side, Modern Healthcare relates,
    • “More than 40 hospitals have converted to rural emergency hospitals since 2023 [under a new federal program]. 
    • “The program has stabilized rural hospital finances but fewer hospitals converted last year.
    • “Hospitals have expanded services to their communities since joining the program.”
  • Federal News Network tells us,
    • “Agencies are getting more information on how to implement the recently finalized “rule of many.” The federal hiring strategy, several years in the making, aims to create broader pools of qualified job candidates while adding flexibility for federal hiring managers.
    • “A series of guidance documents the Office of Personnel Management published earlier this month outlined the steps agencies should take to begin using the “rule of many” when hiring. OPM’s new resources also detail how the “rule of many” intersects with other aspects of the federal hiring process, such as shared certificates, skills-based assessments and veterans’ preference.
    • “Under the “rule of many,” federal hiring managers score job candidates on their relevant job skills, then rank the candidates based on those scores. From there, hiring managers can choose one of several options — a cut-off number, score or percentage — to pare down the applicant pool and reach a list of qualified finalists to select from.”
  • Tammy Flanagan, writing in Govexec, answers “a litany of new questions on how to receive retirement benefits” coming from “an influx of federal retirees due to the Deferred Resignation Program and other separation programs.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Drugmakers developing experimental multiple myeloma drugs may have a quicker path to market under new guidance the Food and Drug Administration published this week.
    • “According to the new framework, the regulator may grant accelerated approvals in some settings based on a therapy’s ability to induce “minimal residual disease” or “complete responses,” both of which are achieved when drugs drastically reduce levels of dysfunctional blood cells in people with the disease.  
    • “The FDA has recently handed accelerated approvals to multiple myeloma drugs like Johnson & Johnson’s Tecvayli and Talvey based on the “objective response rate” — a measure of remissions determined by the presence of disease on a scan — observed in clinical testing.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Despite gains in treatment, cardiovascular disease remains the leading cause of death in the United States, accounting for nearly three in 10 fatalities — 916,000 — in 2023, according to a report published Wednesday by the American Heart Association.
    • “It outnumbers deaths from the second and third leading causes — cancer and accidental injuries — combined.
    • “The statistics are a sobering reminder that there is “a lot of work to do” when it comes to prevention and treatment of heart disease and stroke, said Dr. Donald Lloyd-Jones, a professor of cardiology at Boston University and former president of the association, who was not involved in the new report.”
  • Cardiovascular Business adds,
    • “Cardiology has been shifting away from reactionary treatment strategies to a greater emphasis on prevention. With a shortage of heart failure specialists in the United States and hospitalization rates on the rise, reducing the number of advanced heart failure cases is a major target of such prevention efforts.
    • “A joint scientific statement from the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) about prevention in heart failure was released online in 2025 and then published in the Journal of Cardiac Failure (JCF) to kick off 2026.[1] The goal of the statement is to raise awareness that prevention efforts to stop the advance of heart failure symptoms should start with primary care and general cardiologists before the symptoms of these patients becomes critical. This is part of a wider effort across cardiology and medicine to try and reduce heart failure hospitalizations.”
  • and
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.”
  • The Wall Street Journal relates,
    • “Colorectal cancer is on the rise among young people. Now it is the leading cause of cancer death in the U.S. for those under 50, according to a new analysis. 
    • “More than 1.2 million people under age 50 died of cancer in the U.S. from 1990 through 2023, American Cancer Society researchers reported Thursday.
    • “Some 3,905 people ages 20 to 49 died of colorectal cancer in 2023, according to Cancer Society statistics, compared with 3,809 for breast cancer and 2,086 for brain and other nervous system cancers.
    • “This is absolutely disconcerting,” said Dr. Madappa Kundranda, division chief of cancer medicine at Banner MD Anderson Cancer Center in Phoenix, who wasn’t involved in the research.” * * *
    • “As colorectal cancer among younger people has emerged as a bigger threat, medical groups have lowered the recommended age for colonoscopies that can detect the disease while there are good odds for effective treatment.
    • “Yet not enough people under 50 are getting the screenings, doctors said, prompting calls for a redoubling of efforts to educate doctors and nurses about the need to talk with patients.”
  • The New York Times points out,
    • “Is there a way to use the body’s way of fighting cancers to make a new drug?
    • “Perhaps, according to preliminary research studies.
    • “The idea is to exploit what is known about the growth of cancers. While many grow and spread and are deadly without treatment, some go away on their own or simply do not progress. They remain in the body, harmless and causing no symptoms. It’s contrary to conventional wisdom.
    • “But Dr. Edward Patz, who spent much of his career researching cancer at Duke, has long been intrigued by cancers that are harmless and has thought they might hold important clues for drug development.
    • “The result, after years of research, is an experimental drug, tested so far only in small numbers of lung cancer patients. The results are encouraging, but most promising experimental drugs fail after larger, more rigorous studies.
    • “That hasn’t stopped Dr. Patz from recently starting a company, Grid Therapeutics, hoping that the experimental drug will turn out to be a new type of cancer treatment.”
  • The Washington Post cautions,
    • Obesity in midlife may cause vascular dementia later in life by raising blood pressure over decades and quietly damaging brain vessels, according to new research released Thursday.
    • The danger could be significant. Having a higher body mass index increases the risk of vascular dementia by roughly 50 to 60 percent, according to the study, published in the Journal of Clinical Endocrinology & Metabolism. An association between obesity and dementia has long been the subject of study, and the new research strongly indicates there is indeed a link.
    • “We add a layer of evidence that suggests causality,” said Ruth Frikke-Schmidt, who was the study’s lead author and is a professor and chief physician at Copenhagen University Hospital Rigshospitalet and the University of Copenhagen. “For public health, this is an important message.”
  • Beckers Clinical Leadership informs us,
    • “Even as patient acuity climbed over the last several years, hospitals posted notable gains in mortality and reductions in two major hospital-acquired infections, a new Vizient report found.
    • “The Jan. 22 report is based on an analysis of the Vizient Clinical Data Base, which includes data from more than 1,000 hospitals nationwide. It compares trends from the fourth quarter of 2019 to the second quarter of 2025 across measures of acuity, mortality performance and select hospital-acquired infections.
    • “These improvements occurred during a period marked by workforce shortages, supply chain instability and rising case complexity, signaling that the system’s quality infrastructure is stronger, more adaptive and more scalable than often recognized,” the report said.”
  • Per MedPage Today,
    • “Ten-year follow-up results showed that 37.8% of patients who received antibiotics versus appendectomy had a true recurrence of appendicitis.
    • “Overall, cumulative complication rates at 10 years were significantly higher in the appendectomy group versus the antibiotic group.
    • “The analysis “reaffirms antibiotics as a safe and feasible alternative to appendectomy,” researchers said.”
  • Per Health Day,
    • “Even brief treatment with Ozempic can improve knee replacement outcomes among people with type 2 diabetes.
    • “Taking semaglutide for as little as two to three months improved a person’s odds of avoiding major surgery complications.
    • “Less than a month’s treatment lowered odds of minor complications.”
  • and
    • “Super agers are likely to have genetic advantages that protect their brain health.
    • “They are less likely to carry a gene linked to increased risk of Alzheimer’s.
    • “They also are more likely to have a gene that appears to protect against Alzheimer’s. * * *
    • “Super agers” are people whose brain power at 80 or older compares to that of people 20 to 30 years younger, researchers said.”
  • Truveta adds,
    • “As of December 2025, GLP-1 RA prescriptions account for more than 7% of all prescriptions.
    • “Tirzepatide continues to be the most prescribed anti-diabetic (ADM) and anti-obesity (AOM) medication (sold as Mounjaro and Zepbound, respectively) and showed the largest increase in total prescribing from September to December 2025.
    • “Overall prescribing rates (GLP-1 RA prescriptions per total prescriptions) increased slightly from September to December 2025 (+5.0%); however, first-time prescribing rates declined over the same period (-6.6%). These trends are consistent with first-time prescribing rates seen around the holidays in previous years.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • “The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas.
    • “Insurance technology company Sidecar Health is offering health plans to employers in Texas.
    • The company, which launched in 2018, covers employees in 48 states who work for businesses headquartered in Ohio, Georgia, Florida and Texas. 
    • “Sidecar touts an alternative model promising no prior authorizations, referrals or specific networks. For covered services, the plan will pay for up to a maximum allowable amount based on local market prices, according to the company. If a service is below the benefit amount, members can keep half the savings, Sidecar said in the release. If they receive care that costs more than the benefit amount, members are required to pay the difference.”
  • and
    • “A unique marketing campaign from Blue Cross and Blue Shield of Vermont lays out price variations between specific providers for certain services. 
    • “Blue Cross and Blue Shield of Vermont unfavorably compares costs at the University of Vermont Medical Center to other hospitals.
    • “Industry watchers say it could represent a new era in contract negotiations between health insurance companies and providers.”
  • Beckers Health IT tells us,
    • Amazon’s One Medical and Cleveland Clinic have opened their second collaborative primary care office. 
    • The new office, located in Shaker Heights, Ohio, offers preventive care, chronic disease management and treatment for common illnesses such as colds and flu. Patients also have access to on-site lab services and same- or next-day appointments.
    • The office follows the October opening of the organizations’ first joint primary care site in Northeast Ohio, according to a Jan. 22 news release One Medical shared with Becker’s.
  • Fierce Pharma relates,
    • “As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade, the generic and biosim specialist sees a multibillion-dollar opportunity up for grabs. 
    • “The company detailed its outlook on the upcoming “‘golden decade’ of affordable medicines” at the J.P. Morgan Healthcare Conference last week. Tallying up expected losses of exclusivity across the industry over that period, the Swiss drugmaker sees a generic drug opportunity of up to $340 billion and a biosim opportunity totaling $322 billion.
    • “More than 50 biologic drugs are set to go off patent in the next seven years and have no biosimilars lined up to launch. This situation has created what’s been coined the “biosimilar void” among industry watchers.
    • “While fully dissipating the void will require participation from many biosim players, Sandoz is committed to the cause: The company boasts a plan to target some 60% of the total biosimilar opportunity in sight.
    • “Still, “we want to do more,” the company’s North American president, Keren Haruvi, told Fierce Pharma in an interview on the sidelines of JPM.”
  • MedTech Dive notes,
    • “Abbott’s fourth quarter sales came in below expectations, as the company navigated challenges in its nutrition and diagnostics businesses. Abbott also reported less growth than expected in its medical devices segment. 
    • “The company’s revenue of $11.46 billion for the quarter fell short of analysts’ consensus of $11.8 billion, Leerink Partners analyst Mike Kratky wrote in a research note on Thursday.”

From the artificial intelligence front,

  • Healthcare Dive shares a mixed bag of reports,
    • “Amazon is launching a health-focused artificial intelligence chatbot for members of its One Medical primary care chain, the tech giant said Wednesday. 
    • “The Health AI assistant uses One Medical members’ medical record information to answer health questions and provide guidance on symptoms and potential treatments. Users can also chat with the assistant to book appointments, decide between care settings and renew prescriptions.
    • “The chatbot is built with “multiple patient safety guardrails,” including protocols that connect patients with a provider through messages or an in-person appointment when their clinical judgment is needed, an Amazon spokesperson said.”
  • and
    • “Healthcare workers are using artificial intelligence tools that haven’t been approved by their organizations — a potential patient safety and data privacy risk, according to a survey published Thursday by Wolters Kluwer Health. 
    • “More than 40% of medical workers and administrators said they were aware of colleagues using “shadow AI” products, while nearly 20% reported they have used an unauthorized AI tool themselves, according to the survey by the information services and software firm.
    • “Those unapproved tools might be useful to individual workers, but their health systems haven’t vetted the products’ risks or considered governance processes, according to Dr. Peter Bonis, chief medical officer at Wolters Kluwer. “The issue is, what is their safety? What is their efficacy, and what are the risks associated with that?” he said. “And are those adequately recognized by the users themselves?”
  • and
    • “Misuse of artificial intelligence-powered chatbots in healthcare has topped ECRI’s annual list of the top health technology hazards.
    • “The nonprofit ECRI, which shared its list Wednesday, said chatbots built on ChatGPT and other large language models can provide false or misleading information that could result in significant patient harm.
    • “ECRI put chatbot misuse ahead of sudden loss of access to electronic systems and the availability of substandard and falsified medical products on its list of the biggest hazards for this year.”

MLK Holiday Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, NIH, OPM, U.S. Healthcare–

Happy Martin Luther King, Jr., Day. This is the 40th anniversary of holding a federal holiday to celebrate the life and legacy of this great American leader.

From Washington, DC,

  • This week’s main event on Capitol Hill, at least from the FEHBlog’s perspective is Thursday’s afternoon’s House Ways and Means Committee hearing with Health Insurance CEOs.
  • Federal News Network reports,
    • “The Office of Personnel Management extended the deadline to apply for the U.S. Tech Force, due to what it said has been “tremendous interest and a recent surge in applications.”
    • “The Tech Force program initially launched in December, as a way to temporarily hire technologists into government for two-year stints to work on critical tech challenges across agencies. Those interested now have until Feb. 2 to apply for a spot in the program, according to a Thursday social media post. OPM is targeting 1,000 recruits to the program by March.
    • “It’s not clear how many individuals have so far submitted applications to Tech Force. But OPM Director Scott Kupor said more than 35,000 people expressed initial interest in the program.
    • “We’re working through our funnel now of how many of those people will give us a resume, how many people will do the application,” Kupor said Wednesday during an event hosted by Washington AI Network. “From my perspective, the interest is phenomenal.”
  • Per a National Institutes of Health news release,
    • “Effective Jan. 31, 2026, Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH), is retiring from federal service. Dr. Gibbons has led NHLBI since 2012, dedicating his time to championing research research in the prevention and treatment of heart, lung, and blood diseases and sleep diseases and disorders.” * * *
    • “David Goff, M.D., Ph.D., will serve as Acting NHLBI Director while a search for a new director is conducted.”

From the Food and Drug Administration front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group’s Optum Rx is monitoring three notable drug candidates that might be approved in the next few months, according to its winter 2026 report published Jan. 2.
    • “Two of the medications Optum Rx is tracking are also on GoodRx’s list of 11 upcoming FDA approval decisions to watch in 2026 — Anaphylm for anaphylaxis and Sotyktu for psoriatic arthritis. 
    • “Here is a breakdown of the three FDA decisions Optum Rx is closely watching:
      • “1. Anaphylm (dibutepinephrine) is under FDA review for the treatment of severe allergic reactions, including anaphylaxis. If approved, the sublingual films will be the first oral epinephrine product for allergic reactions.” * * *
      •  “2. Bristol Myers Squibb is seeking another indication for Sotyktu (deucravacitinib), an FDA-approved pill for adults with moderate to severe plaque psoriasis. The potential new indication is the treatment of adults with active psoriatic arthritis, a chronic autoimmune condition that affects about 1 million U.S. adults.” * * *
      •  “3. Novo Nordisk resubmitted an application for FDA approval of insulin icodec, a once-weekly basal (long-acting) insulin to improve glycemic control in patients with Type 2 diabetes.”
  • Per MedPage Today,
    • “Meals and snacks with “GLP-1 Friendly” labels on the packaging are becoming more common in U.S. supermarkets as a growing number of Americans try obesity drugs like semaglutide (Wegovy) and tirzepatide (Zepbound) to lose weight.
    • But the labels aren’t regulated by the FDA, unlike the popular medications themselves. Dietitians say people taking GLP-1 drugs need to read ingredient lists and talk to experts about what nutrients they need — and don’t need.
    • “A drug does not educate you on how to eat properly,” said Suzy Badaracco, MS, a registered dietitian and president of the food trends forecasting firm Culinary Tides. “You’re not magically going to be educated — without a doctor’s help — to eat healthy.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A new study helps explain why you get sick from a common cold virus. The secret, it turns out, lies inside your nose.
    • “Winter brings a surge of respiratory illnesses, including rhinoviruses, the most frequent cause of the common cold. How your nasal-passage cells respond to the rhinovirus helps determine whether you get sick and how bad you feel, according to a new study published Monday in the journal Cell Press Blue.
    • “This study offers a more detailed picture of what’s going on during common cold infections than we ever had,” said Dr. Ellen Foxman, an immunologist at the Yale School of Medicine and senior author of the new research.”
  • The Washington Post informs us,
    • “Since the inception of antibiotics in 1910 with the introduction of salvarsan, a synthetic drug used to treat syphilis, scientists have been sounding the alarm about resistance. As a microbiologist and biochemist who studies antimicrobial resistance, I [André O. Hudson] see four major trends that will shape how we as a society confront antibiotic resistance in the coming decade.” * * *
      • “Faster diagnostics are the new front line” * * *
      • “Expanding beyond traditional antibiotics” * * *
      • “Antimicrobial resistance outside hospitals” * * *
      • “Policies on what treatments will exist in the future” * * *
    • “Antibiotic resistance is sometimes framed as an inevitable catastrophe. But I believe the reality is more hopeful: Society is entering an era of smarter diagnostics, innovative therapies, ecosystem-level strategies and policy reforms aimed at rebuilding the antibiotic pipeline in addition to addressing stewardship.
    • “For the public, this means better tools and stronger systems of protection. For researchers and policymakers, it means collaborating in new ways.
    • “The question now isn’t whether there are solutions to antibiotic resistance — it’s whether society will act fast enough to use them.”
  • and
    • “As more continues to be understood about the health benefits associated with GLP-1 drugs, a growing body of science is aiming to answer whether the popular weight-loss medication can help with one of the world’s leading causes of death: cancer.
    • “Research into the effects of GLP-1 drugs on the risks of developing and surviving cancer is early, and results so far have been somewhat of a mixed bag. While some studies suggest the medication could be linked to a lower chance of developing certain cancers and better outcomes after being diagnosed, researchers have also found little to no effect on other types. In some cases the drugs have been tied to a slight increase in risk. Experts also noted that the medication’s potential long-term effects are not yet well understood.
    • “We don’t know all the good effects, but we don’t know all the bad effects either,” said Sherry Shen, a medical oncologist specializing in breast cancer at Memorial Sloan Kettering Cancer Center.”
  • Per MedPage Today,
    • “Patients with acute mpox infections experienced persistent physical, behavioral, and psychosocial side effects more than a year after illness, a cohort study suggested.
    • “Among 154 people with clade II mpox infections, 58% had at least one persistent sequelae, 56% of which were related to appearance, 11 to 18 months after illness, reported Preetam Cholli, MD, of the CDC, and colleagues in the Annals of Internal Medicine. 
    • “Specifically, 51% had sequelae at one to two sites, 8% were affected at 10 or more sites, 83% had persistent skin discoloration, and 51% had scars. Most had fewer than 10 scars (82%) or discrete pigmented areas (86%). Persistent physical or appearance-related sequelae were more likely in those with 10 or more acute lesions, merged lesions 2 cm or larger, or bacterial superinfection.
    • “Our findings suggest that clinicians should consider more aggressive monitoring and treatment or early dermatology consultation to try to mitigate the possibility of long-term scarring for lesions at or exceeding 2 cm in size,” Cholli and team wrote.”
  • Genetic Engineering and BioTechnology News lets us know,
    • “Learning to read and write is the beginning of literacy, a progression now mirrored in modern genomics. Scientists first read the human genome, a three-billion-letter biological book, in April 2003. Since then, researchers have steadily advanced the ability to write DNA, moving far beyond single-gene construction. New technologies enable the synthesis of viral, bacterial, and yeast genomes. Now, cutting-edge projects are building the tools needed for large-scale chromosome engineering, with the long-term goal of constructing the first human genome from scratch.
    • “In the U.K., a Wellcome-funded five-year proof-of-concept project, Synthetic Human Genome (SynHG), is taking aim at developing the foundational and scalable technologies to achieve reliable genome construction. The £10 million (~$13 million in U.S.) project established a consortium consisting of five university teams from Cambridge, Kent, Oxford, Manchester, and Imperial. Embedded within the ambitious scientific undertaking is also a research wing designed to address socio-ethical implications. According to Wellcome, “Achieving reliable genome design and synthesis–i.e., engineering cells to have specific functions—will be a major milestone in modern biology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Bloomington, Minn.-based HealthPartners launched its copay-only health plan, Simplica NextGen Copay, this year. The plan sets prices for in-network care without a deductible or coinsurance.
    • “Moe Suleiman, senior vice president of commercial business, and Maggie Helms, senior vice president, chief data, AI and digital officer, sat down with Becker’s to unpack the effort — and how to do it the right way.
    • “The pair said there can be misconceptions surrounding copay-only plans. Some may believe copay-only plans must replace all existing other plan types in a portfolio, when that is not necessarily the case. Copay-only plans can also stand alongside familiar options, such as a tax-advantaged health savings account, so members can have a choice.”
  • KFF offers a table of “Hospital Expenses per Adjusted Inpatient Day by Ownership Type” from 1999 through 2024.
  • Radiology Business relates,
    • “The Society of Interventional Radiology and other members of a coalition of imaging industry stakeholders are pointing to a new analysis from the Progressive Policy Institute. It notes that, between 2019 and 2023, the share of physician practices owned by hospitals and other corporate entities leapt from 39% to 59%.
    • “Meanwhile, the proportion of docs employed by such entities increased from 62% to 78%. SIR, AdvaMed, the American College of Radiation Oncology, Philips, Abbott and others in the Office-Based Facility Association (OBFA) contend more must be done to reverse these trends and protect private practices.
    • “Office-based facilities are a cornerstone of affordable, patient-centered care—but they’re under pressure like never before,” Robert Tahara, MD, policy chair of the association and a Pennsylvania-based vascular surgeon, said in a Jan. 15 announcement. “We urge policymakers at all levels to act now to support payment policies and competitive practices that keep healthcare accessible, affordable, and rooted in community practice.”
  • Per HR Dive,
    • “Organizations in 2026 are facing culture dissonance as companies expect more from employees without offering more in return, according to a recent workplace trend report from business and technology firm Gartner.
    • “Negative psychological impacts resulting from the pervasiveness of artificial intelligence, as well as poor quality work resulting from an “overwhelming focus on AI adoption” were also among the findings reported in the research, which identified nine trends that CHROs will need to address in 2026. 
    • “Another aspect of AI’s influence has been job seekers’ use of the tech to make their applications easier and more appealing, even as organizations use AI to sift through a high volume of resumes. In the coming year, CHROs will need to focus on the human aspect of recruiting to counteract this trend, per Gartner.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, OPM, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Beckers Payer Issues offers three takeways from the President’s healthcare plan that was announced yesterday.
    • “President Donald Trump released a sparsely detailed healthcare policy framework Jan. 15 that calls on Congress to codify voluntary drug pricing agreements with major pharmaceutical companies, direct payments to Americans over extending enhanced ACA subsidies, and expand price transparency requirements for insurers and providers. The proposal does not identify how most of its provisions would be implemented or enforced.”
  • Rick Pollack, the American Hospital Association’s President, points the healthcare cost increase finger at health insurers.
  • Healthcare Dive adds,
    • “The federal government will pay an estimated $76 billion more to cover Medicare Advantage seniors this year than it would if those same seniors were in traditional Medicare, according to new estimates from an influential advisory group.
    • “It’s a smaller sum than last year thanks to the continued phase-in of a new risk adjustment model. Overpayments were estimated to reach $84 billion in 2025.
    • “Still, the report released Friday by the Medicare Payment Advisory Commission is likely to add more fuel to concerns about overpayments in the privatized Medicare program, which has grown to cover more than half of all Medicare enrollees.”
  • The American Hospital Association News tells us,
    • “The Medicare Payment Advisory Commission Jan. 15 voted to recommend that Congress update Medicare payment rates for hospital inpatient and outpatient services by the current law amount for 2027 and reiterated its recommendation to distribute an additional $1 billion to safety-net hospitals by transitioning to a Medicare safety-net index policy. The AHA Jan. 9 urged the commission for higher updates.
    • In other action, MedPAC recommended that Congress update 2027 Medicare payments for physicians and other health professional services by current law plus 0.5%. The commission also recommended reducing the 2027 payment rates for home health agencies by 7%, skilled nursing facilities by 4% and inpatient rehabilitation facilities by 7%.
  • and
    • The White House hosted a roundtable on rural health Jan. 16 that included health care leaders, legislators and administration officials. The event included discussion on the Rural Health Transformation Fund and the “The Great Healthcare Plan,”with a focus on “most favored nation” prescription drug pricing and other topicsimpacting rural health. Speakers included President Trump, CMS Administrator Mehmet Oz, M.D., Andrew McCue, M.D., a cardiologist at AdventHealth, Senator Dan Sullivan, R-Alaska, Gov. Jim Pillen, R-Neb., Reps. Rob Bresnahan, R-Pa., Mike Lawler, R-N.Y., and Secretary of Agriculture Brooke Rollins.”
  • Per Medical Economics,
    • “Telehealth adoption did not increase overall office visit volumes among traditional Medicare patients, with visit volumes remaining stable or declining through mid-2024.
    • “Researchers categorized specialists into low, medium and high telehealth usage groups, finding declines in outpatient office visits across all groups.
    • “The study suggests telehealth serves as a substitute for in-person visits, not increasing total utilization among Medicare fee-for-service beneficiaries.
    • “Congress must decide on extending Medicare’s telehealth coverage standards, impacting patient access to virtual care.”
  • Per a Senate news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and Maggie Hassan (D-NH) support the Trump administration taking action to implement the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it.
    • “Since the bipartisan legislation, led by Cassidy and Hassan, was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • “We are writing to express our support of the Department’s efforts to improve the implementation of the No Surprises Act and encourage the pursuit of additional solutions to ensure that the process established under the law to resolve payment disputes between providers, facilities, and health plans is effective,” wrote the senators. “We look forward to continuing to work with the Department and stand ready to assist to ensure that the implementation of the No Surprises Act continues to be successful.”
  • An HHS news release informs us,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today [January 13] a $231M funding opportunity to administer the 988 Suicide & Crisis Lifeline. The 988 Lifeline is comprised of a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded 988 network administrator. In 2025, 988 received more than 8 million contacts from help seekers via call, text, chat and ASL videophone.”
  • NCQA calls our attention to its 2026 trends.
    • “Re-Thinking Our Approach to Population Health”
    • “Understanding Health Differences Within Populations and Communities”
    • “Shaping the Future of Primary Care”
    • “Integrating Primary Care and Behavioral Healthcare”
    • “Advancing the Transition to Digital Quality Measurement”
    • “Expanding Use of Clinical Data in HEDIS®”
    • “Improving Quality of Care for Patients with Cardiovascular-Kidney-Metabolic Syndrome”
    • “Defining High Quality Diabetes Care”
    • “Reducing the Administrative Burden of Utilization Management”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court agreed to hear Bayer AG’s appeal taking aim at thousands of lawsuits targeting its top-selling Roundup weedkiller for causing cancer. 
    • “The high court agreed Friday to hear Bayer’s challenge to a $1.25 million Missouri jury verdict against the company’s Monsanto unit over Roundup on the grounds some of the claims in the 2023 case were preempted by federal law. Bayer officials hope the justices’ ruling will help knock out thousands of Roundup cases that include failure-to-warn claims.”
  • and
    • “The US Supreme Court will hear generic drug maker Hikma Pharmaceuticals USA Inc.’s challenge of an appeals court holding that it induced doctors and pharmacists to prescribe its heart medicine for off-label treatments that would infringe a rival’s patents. (Case no.
      24-1068)
    • “The government urged the high court to reverse the US Court of Appeals for the Federal Circuit’s ruling reviving a lawsuit from Amarin Pharma Inc. Amarin claimed that Hikma infringed its patents despite the generic company’s use of a “skinny label” instructing users only to take the drug to treat severe hypertriglyceridemia, a method-of-use no longer covered by any Amarin patent.” (Case No. 24-889).

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old and RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is low but increasing nationally.
    • “COVID-19
      • “COVID-19 activity is low but increasing nationally.
    • “Influenza
      • “Seasonal influenza activity remains elevated across the country, but influenza activity has decreased or remained stable for two consecutive weeks. CDC will continue to monitor closely. A second period of increased influenza activity does often occur after the winter holidays.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old and hospitalizations among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains suboptimal for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • Beckers Hospital Review offers five notes about dipping numbers of hospital admissions for flu.
  • The University of Minnesota’s CIDRAP relates,
    • “Two new analyses, one from France and one from China, suggest that seasonal influenza vaccination provided moderate protection during the early months of the 2025–26 flu season, despite the rapid spread of influenza A(H3N2) subclade K viruses, which differ from the strains anticipated during vaccine development for the current flu season.”
  • STAT News notes,
    • “Reported measles cases in South Carolina surged by almost 30% in the last few days, state health officials said Friday.
    • “The South Carolina health department reported 124 new cases since Tuesday, bringing the state’s total to 558 in a wave of infections centered around an outbreak in Spartanburg County.”
  • The AP informs us,
    • “Wastewater testing can alert public health officials to measles infections days to months before cases are confirmed by doctors, researchers said in two studies published Thursday by the Centers for Disease Control and Prevention.
    • “Colorado health officials were able to get ahead of the highly contagious virus by tracking its presence in sewer systems, researchers wrote. And Oregon researchers found wastewater could have warned them of an outbreak more than two months before the first person tested positive.
    • “The findings add to evidence that wastewater testing is a valuable weapon in tracking disease, including COVID-19, polio, mpox and bird flu.”
  • The American Hospital Association News points out,
    • “The AHA has published a webpage that highlights facts, causes, effects and solutions that hospitals and health systems can use for reducing the risk and severity of postpartum hemorrhage. Resources include how to prepare for, train, measure and support the workforce and patients during maternal care. LEARN MORE“
  • The Washington Post reports,
    • “A sweeping new study of psychiatric and genetic records has the potential to change treatment for millions of psychiatric patients, finding that many conditions involve similar genes and may not need to be treated as distinct illnesses.
    • “In essence, the study suggests that bolstering the traditional emphasis on patient behavior with a deeper understanding of the biology of mental illness could lead to better treatment.
    • “Published in Nature, the paper addresses the boundaries psychiatry uses to separate similar conditions like bipolar disorder and schizophrenia. The research also suggests that linking genes to the brain processes they influence will provide psychiatrists with greater insight into their patients, and guide researchers toward new therapies.”
    • “The findings could also spare patients the burden of carrying multiple different diagnoses that require an assortment of different pills.”
  • Per Healio,
    • “People with hypertension who meet guideline-directed levels of weekly physical activity in just 1 or 2 days may derive similar mortality benefit vs. those who are consistently active, researchers reported.
    • “The 2020 WHO guidelines on physical activity and sedentary behavior, published in the British Journal of Sports Medicine, recommended 150 minutes or more of moderate to vigorous physical activity per week for people with chronic conditions such as hypertension.”
  • Per Fierce Pharma,
    • “Just days after AbbVie unveiled a major new oncology play in the form of its high-dollar RemeGen collab, the Illinois drugmaker closed out the week with some mixed news for its marketed cancer offering Epkinly.
    • “Friday afternoon, the company and its partner Genmab shared word that the phase 3 Epcore DLBCL-1 trial missed on its primary endpoint of overall survival. Specifically, the partners’ Epkinly failed to mount a statistically significant OS benefit among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Despite ongoing pushback, the University of Nebraska Board of Regents on Jan. 15 unanimously approved a proposed deal to bring jointly operated Nebraska Medicine under its full ownership and governance.
    • The deal would see co-owner Clarkson Regional Health Services offload its 50% share of the independently run system for $500 million plus another $300 million for owned land and buildings. Nebraska Medicine’s board is staunchly opposing the plan, and launched a public messaging campaign warning that sole governance, among other possibilities, would allow the university to redirect healthcare funds to cover its own budget gaps.
  • Beckers Hospital Review tells us,
    • “Nashville, Tenn.-based Vanderbilt Transplant Center completed 960 solid organ transplants in 2025 — the most ever performed by a single center in one year — making it the largest transplant center by volume in the U.S. 
    • “In addition to the record number of solid organ transplants, the center set a world record for the performing 210 adult and pediatric heart transplants in 2025, according to a Jan. 14 news release from Nashville-based Vanderbilt University Medical Center.” 
  • MedTech Dive informs us,
    • “Intuitive Surgical executives said this week that general surgery, particularly in after-hours care, drove procedure growth for the da Vinci robotic platform. U.S. procedures increased 15% in the fourth quarter compared with a year ago.
    • “After-hours procedures such as gallbladder removal and appendectomy using a da Vinci robot grew 35% in the fourth quarter, CFO Jamie Samath said in a presentation at the J.P. Morgan Healthcare Conference.
    • “Intuitive has been ramping up the launch of its latest system, da Vinci 5, making it broadly available in the U.S. in the third quarter of 2025. Da Vinci 5 is also cleared in Korea, Japan and Europe. 
    • “The strong launch has exceeded the company’s expectations, with about 1,200 da Vinci 5 systems installed and 270,000 procedures performed globally, CEO Dave Rosa said at the conference.”

Midweek report

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

From Washington DC

  • The House of Representatives approved an appropriations bill (HR 7006) that includes OPM appropriations by a 341-79 votes this afternoon. The bill now moves onto the Senate for its consideration.
  • Roll Call offers more details on the state of the Congressional effort to pass the twelve appropriations bills in regular orde.
  • Beckers Payer Issues reports,
    • “A bipartisan group of senators working to revive the ACA enhanced tax credits that expired at the end of 2025 said they won’t have their proposal ready until the end of January, Politico reported Jan. 13. 
    • “Sen. Bernie Moreno, R-Ohio, a lead negotiator, previously said the legislative text could be ready as early as Jan. 12, but told Politico, “[W]e have to make sure we get this right.”
    • “Mr. Moreno said Republicans and Democrats involved in the discussions have not yet resolved how to address the Hyde Amendment, which bars federal funding from covering abortions, according to the report. Under the law, ACA marketplace insurers must segregate funds that go toward abortion services from funds that go to all other health services. Republicans and Democrats disagree on whether that segregation complies with the Hyde Amendment.” 
  • Axios adds,
    • “Long-stalled bipartisan priorities that are in play include an overhaul of pharmacy benefit manager practices, as well as a measure that would place more controls on Medicare outpatient spending. 
    • “They’d likely be combined with a renewal of health programs due to expire Jan. 30, including certain Medicare telehealth flexibilities and funding for community health centers.”
  • Healthcare Dive tells us,
    • “National healthcare spending reached $5.3 trillion in 2024 as Americans continued to ravenously consume healthcare coming out of the coronavirus pandemic, according to a new report from CMS actuaries.
    • “Growth in healthcare spending continued to outpace that of the overall economy. As a result, healthcare’s share of the U.S. gross domestic product increased from 17.7% in 2023 to 18% in 2024, researchers said in the report released Wednesday in Health Affairs.
    • “The sharp health spending growth was not driven by increasing costs for goods and services. Instead, it was fueled by intense consumer demand for medical care, and changes in what types of medical care was consumed, CMS actuaries said.
    • “Prices are a factor. They’re part of the equation. But non-price factors were the driver,” Micah Hartman, a statistician with the CMS’ Office of the Actuary, said in a call with press on Wednesday.”
  • Modern Healthcare adds,
    • “Health insurers struggling with rising medical expenses may have less of a cushion in 2026. 
    • “Companies such as UnitedHealth Group reaped gains on their investments over the past several years that bolstered their finances and offset narrowing profit margins or losses from operations.
    • “Broader economic factors are at work though. The Federal Reserve signaled last month that it intends to cut the benchmark interest rate for the fourth time since the beginning of 2025. In addition, Standard & Poor’s Global Ratings projects that yields on 10-year Treasury bonds will continue to decline, which would indicate waning investor confidence in the economy. 
    • “These circumstances would squeeze health insurance company finances at a time when many of the companies are struggling to restore profit margins, said Whit Mayo, senior managing director and senior research analyst at investment bank Leerink Partners.
    • “It’s not a helpful headwind in the context of the challenging, persistent elevated-cost-trend environment,” Mayo said.” 
  • MedPage Today points out,
    • “There’s a reason that the ACA specifies the [U.S. preventive services] task force as the organization insurers must pay attention to, according to Aaron Carroll, MD, president and CEO of AcademyHealth. “No one else has the rigorous transparency in process that the USPSTF has,” he said in an online interview at which a public relations person was present. “They are very clear and transparent in how they gather the evidence, how they grade the evidence, what was actually included, and how they are deliberating. Other organizations may do that, but they do not do it as consistently … which is why the ACA is pegged to them and not to each individual society.”
    • “However, the Trump administration has taken actions recently that have slowed the task force’s work. A planned meeting of the task force in July was canceledopens in a new tab or window, and its November meeting was postponedopens in a new tab or window. No new meeting dates have been announced, according to the New York Timesopens in a new tab or window. In addition, the Timesreported, the terms of five members of the 16-member task force expired on Dec. 31, with no plans announced for their replacements, even as four draft guidelines are set to be finalized. Those guidelines address screening adults for unhealthy alcohol use, self-swabs for cervical cancer screening, counseling for women at increased risk for perinatal depression, and the use of vitamin D supplements to prevent fractures and falls in older people (the task force’s draft guideline recommended against the latter preventive measure).” * * *
    • “Last week, the Health Resources and Services Administration (HRSA) issued guidelines in support of self-swabs to screen for cervical cancer. However, although the ACA also requires insurers to cover preventive services recommended by HRSA, “the difference is in the rigor of the process with high transparency and public input at every stage of the process that the USPSTF adheres to, as opposed to the HRSA process,” Melissa Simon, MD, MPH, vice chair of obstetrics and gynecology research at Northwestern University in Chicago, said in an email. “It is through that highly rigorous and successful methodology that USPSTF adheres to for the decades it has been in existence that lends itself to [being] one of the most trusted preventive services [recommendation bodies] for the U.S.”
  • Fierce Healthcare informs us,
    • “The Paragon Health Institute, a conservative health policy think tank, has launched an AI Initiative that will deliver market-based policy recommendations to the Trump administration and Congress on AI in healthcare. 
    • “Paragon already has an ear with the administration. Its president, Brian Blase, was an economic advisor to President Donald Trump during his first term and formerly worked at the Heritage Foundation. Moreover, several Paragon directors and advisers joined the second Trump administration to lead health policy. Some of the think tank’s proposals, including limits on states’ use of federal Medicaid funds, also made it into the text of last summer’s One Big Beautiful Bill Act.
    • “The Health AI initiative will be led by Kev Coleman, a technologist and healthcare researcher, who has already published several policy papers on the topic as a research fellow at Paragon.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is expected to decide on approval of Eli Lilly’s obesity pill orforglipron in the second quarter of 2026, Lilly CEO David Ricks said Tuesday, giving it a chance to quickly follow to market an oral version of Wegovy that rival Novo Nordisk launched last week. 
    • “The FDA granted Lilly a “national priority” voucher for orforglipron that could significantly accelerate the agency’s evaluation. While no statutory deadline exists under that program because it’s never been authorized by Congress, Ricks said he expects a “rapid review” that is “moving at pace.”
    • “A second-quarter launch would be well-timed for Lilly to begin selling orforglipron to the millions of people enrolled in Medicare, which will have broad access to obesity medications beginning in April.”
  • MedPage Today relates,
    • “Modern Warrior is recalling all lots of its Modern Warrior Ready supplement, marketed for boosting brain function, after the detection of undeclared 1,4-DMAA, aniracetam, and tianeptine, the latter of which has been linked to suicidal ideation or behavior in kids and young adults, according to the FDA. (The Hill)”
  • and
    • “The FDA requested that manufacturers of GLP-1 receptor agonists remove information regarding risks of suicidal behavior and ideation from drug labels following a detailed review of existing data, the agency announced on Tuesday.
    • “Affected products include those indicated for weight management, including tirzepatide (Zepbound), semaglutide (Wegovy), and liraglutide (Saxenda).
    • “Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 receptor agonist medications,” the agency said in a statement.”
  • and
    • “The FDA told influenza vaccine makers they should add a warning about an increased febrile seizure risk in babies and preschoolers the day after flu vaccination.
    • “The agency made the announcement opens in a new tab or windowin safety labeling notification letters sent Jan. 9 to the manufacturers of six flu vaccines.
    • “The new language in the label would state, “In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.”
  • MedTech Dive notes,
    • “Boston Scientific has received Food and Drug Administration approval for a new pulsed field ablation catheter that is indicated for use as an adjunctive device in a type of ablation that is performed when treating persistent atrial fibrillation.
    • “Called Farapoint, the device can deliver linear and focal lesions across complex heart anatomies in a single catheter while preserving surrounding cardiac tissue, the company said in an emailed statement Tuesday. The catheter can be combined with the company’s Faraview software module on the Opal HDx mapping system to enhance visualization of the catheter and lesion formation.
    • “Boston Scientific said clinical data supporting the approval, in cavotricuspid isthmus ablation, demonstrated the device was safe and effective, and showed high effectiveness in preventing atrial flutter recurrence.”

From the judicial front,

  • Beckers Payers Issues discusses ten recent healthcare billing fraud cases.
  • It’s worth adding that the GAO announced today,
    • “The federal government loses hundreds of billions of dollars annually to fraud. We issued the Fraud Risk Framework in 2015 to help managers prevent, detect, and respond to fraud.
    • “However, agencies aren’t doing enough to evaluate their antifraud efforts. In 2023, we surveyed 24 federal agencies and found
      • a third didn’t have regular monitoring or evaluation activities
      • half didn’t regularly make changes based on evaluation results
    • “We are issuing this technical appendix to our framework to help managers evaluate and adapt their antifraud efforts. These efforts can aid program integrity, protect taxpayer dollars, and maintain public trust.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “South Carolina health officials yesterday said the state now has 434 measles cases after 124 new cases have been confirmed. 
    • “There are currently 409 South Carolinians in quarantine and 17 in isolation, with some quarantines extending to February 6. Mobile vaccine units will be active this week, and officials urge local residents to get vaccinated.” * * * 
    • “In other measles news, Utah has 25 new cases, raising the state total to 201. Southwest Utah has the most cases, at 147, followed by Utah County with 24 cases, and Wasatch County with 9 cases. 
    • “Arizona officials yesterday confirmed three new measles cases in the state, all from this year. All three are in Mohave County, which has seen a lingering cross-border outbreak with Southwest Utah for several months. Arizona’s outbreak has now reached 217 infections.”
  • STAT News reports,
    • “U.S. overdose deaths fell through most of last year, suggesting a lasting improvement in an epidemic that had been worsening for decades.
    • “Federal data released Wednesday showed that overdose deaths have been falling for more than two years — the longest drop in decades — but also that the decline was slowing.
    • “And the monthly death toll is still not back to what it was before the Covid-19 pandemic, let alone where it was before the current overdose epidemic struck decades ago, said Brandon Marshall, a Brown University researcher who studies overdose trends.
    • “Overall I think this continues to be encouraging, especially since we’re seeing declines almost across the nation,” he said.”
  • Per Cardiovacular News,
    • “In many ways, cardiovascular health throughout the United States has improved significantly over the years. However, thanks in part to an aging population and the impact of the COVID-19 pandemic, there are certain areas where patient outcomes are trending in the wrong direction.
    • “To learn more about this topic, researchers performed the first comprehensive report of its kind, tracking the latest data on a variety of risk factors and cardiovascular conditions. They published their findings in JACC, the flagship publication of the American College of Cardiology (ACC).[1] 
    • “Progress in cardiovascular health depends on knowing where we stand,” wrote first author Rishi K. Wadhera, MD, MPP, MPhil, associate director and section head of health policy at Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center, and colleagues. “To improve, we must measure—not occasionally, but consistently, transparently and with purpose.”
    • “One key takeaway from the report is that there is still plenty of room for improvement in terms of patient outcomes.
    • “Across all risk factors and conditions, persistent disparities by race, geography, and socioeconomic status emerge as a central finding—one that demands focused attention and action,” the authors wrote. “The report also reveals other critical gaps: places where information is incomplete, where our collective understanding falls short, and where new data are urgently needed.”
  • CNN reports,
    • “The Defense Department has spent more than a year testing a device purchased in an undercover operation that some investigators think could be the cause of a series of mysterious ailments impacting US spies, diplomats and troops that are colloquially known as Havana Syndrome, according to four sources briefed on the matter.
    • “A division of the Department of Homeland Security, Homeland Security Investigations, purchased the device for millions of dollars in the waning days of the Biden administration, using funding provided by the Defense Department, according to two of the sources. Officials paid “eight figures” for the device, these people said, declining to offer a more specific number.
    • “The device is still being studied and there is ongoing debate — and in some quarters of government, skepticism — over its link to the roughly dozens of anomalous health incidents that remain officially unexplained.
    • “CNN has asked the Pentagon, HSI and the DHS for comment. The CIA declined to comment.”
  • MedPage Today points out,
    • “Nearly 76% of households with prediabetes patients had additional members who had diabetes risk factors.
    • “Many of these household members had overweight or obesity.
    • “EHR data could identify at-risk households and help target family-centered diabetes prevention strategies, the researchers suggested.”
  • and
    • “Physicians viewed 17% of patient encounters as difficult, according to a meta-analysis.
    • “Patient characteristics associated with perceived difficulty included personality disorders, depression, anxiety, and chronic pain.
    • “The researchers suggested a need for more training in handling difficult encounters.”
  • Healio notes,
    • “Bystander CPR as depicted on TV frequently did not align with correct real-world procedures and experience.
    • “These inaccuracies may skew lay perceptions of cardiac arrest and negatively influence bystander CPR.”

From the. J.P. Morgan healthcare conference,

  • Genetic Engineering and Biotechnology News reports,
    • “They met for the first time in 2018. David A. Ricks, a year into his tenure as Eli Lilly’s Chair and CEO, hosted Jensen Huang at Lilly’s Indianapolis headquarters campus, where the Nvidia founder and CEO gave a talk to the pharma giant’s management team about a new technology called artificial intelligence (AI) and its potential in reshaping drug discovery.” * * *
    • “The two CEOs recalled their first meeting on Monday, when they entertained a packed ballroom at the Fairmont San Francisco hotel, a hilly half-mile north of where the J.P. Morgan 44th Annual Healthcare Conference is taking place. The occasion was a Huang-hosted “fireside chat” in which he and Ricks discussed the companies’ latest partnership, and extolled the promise and potential of AI to reshape not just drug discovery but the development of new treatments and their uptake by patients.
    • “The Silicon Valley microprocessing giant and pharma powerhouse announced a five-year, $1 billion partnership to create a “Co-Innovation AI Lab” designed to address key challenges in AI drug discovery.”
  • STAT News lets us know,
    • “Pfizer CEO Albert Bourla said earlier this week that “the goal in obesity is to become a leading player.” No surprise. But he was also asked about his prediction a year ago that President Trump would be a net positive for the pharmaceutical industry.
    • “Yes,” he said, “but I have to say that I got scared big time” along the way. The big win, from his perspective: The United Kingdom agreeing to raise prices for medicines as part of a trade deal with the U.S. This, he said, changed the dynamic between European companies and the pharmaceutical industry and would not have happened without Trump, who, Bourla also reiterated, deserved a Nobel Prize for supporting the development of Covid vaccines.
    • “But Bourla also expressed some worries about elements of the administration. He continued to say that the pressure it was putting on vaccines is “an anomaly that will correct itself” and reiterated that Pfizer is doing its own vaccine research, including developing a Lyme disease inoculation.
    • “He also expressed concern about developments at the Food and Drug Administration, including the departure of former top official Richard Pazdur. Bourla called Pazdur “a legend in regulatory work globally” and said that he was “very concerned” when Pazdur resigned after only two weeks on the job.”
  • Fierce Healthcare reports,
    • “Surescripts is teaming up with Good Rx to surface key prescription discounts to consumers.
    • “The health information network announced Tuesday at the J.P. Morgan Healthcare Conference that it would launch Script Corner, a new patient experience platform. Script Corner unites key benefit data, medication management tools and personalized engagement to smooth out their medication experience.
    • “The tool is also being built with price transparency in mind, in part through offering discounted cash prices in an exclusive partnership with GoodRx.
    • “Frank Harvey, CEO of Surescripts, said at the conference that while many apps and tools aim to arm patients with key transparency data, but the Script Corner platform is the first to put that in the palm of their hands.”
  • Fierce Healthcare also offers more stories from day 3 of the conference.

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

  • Fierce Healthcare reports,
    • “Insurance giant UnitedHealthcare is rolling out a new program that aims to support the finances of cash-strapped rural hospitals.
    • “Through the pilot, UHC will accelerate the payment timelines in its Medicare Advantage plans by 50% over the next six months, lowering the time from an average of less than 30 days to less than 15 days, according to an announcement from the company.
    • “The insurer said in the announcement that the program is designed to “deliver immediate cash‑flow relief and support the sustainability of these important rural hospitals.” * * *
    • “The pilot will initially launch in four states: Oklahoma, Idaho, Minnesota and Missouri. UnitedHealth said the first participants were selected based on their potential to “maximize impact” and support the future of this initiative and the development of additional interventions in rural healthcare.”
  • Beckers Hospital Review shares “McKinsey’s 2026 healthcare predictions: 5 takeaways for hospital leaders.” 
  • Fierce BioTech relates,
    • “Still riding the high of last year’s twice-yearly HIV PrEP approval of lenacapavir as Yeztugo, Gilead Sciences is approaching dealmaking from a “position of strength” as a more mature biopharma, according to CEO Daniel O’Day.
    • “When you’re a company that’s cured a disease and showed curative potential in another disease and are on the verge of ending an epidemic, you’re kind of bold about your aspirations,” said O’Day, referring to the company’s hepatitis C and HIV medicines.
    • “Since O’Day joined Gilead from Roche in 2018, the California company has built three primary focus areas: virology, cancer and inflammation. In all three, Gilead’s recent successes have given the pharma the luxury of being selective in the external assets it considers, O’Day explained.
  • Healthcare Dive calls attention to the “Top healthcare AI trends in 2026.”
    • “While health systems will continue their AI rollout, use of the technology could evolve amid intensifying competition from EHRs, fragmented regulations and growing M&A opportunities.”

Tuesday report

David Ermer–CDC, Congress, Electronic health records, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Tomorrow, the House of Representatives will vote on the appropriations bill that funds the FEHB and PSHB, among other programs, H.R. 7006 – Financial Services and General Government and National Security, Department of State, and Related Programs Appropriations Act, 2026
  • Beckers Hospital Review tells us whether the ACA healthcare premium subsidies stand.
  • Fierce Healthcare adds,
    • “The Trump administration has released a new update on enrollment on the Affordable Care Act’s exchanges, with signups lagging notably behind figures for the 2025 plan year.
    • “Per the latest snapshot report, nearly 22.8 million people have signed up for coverage across the exchanges through Jan. 3. By comparison, 23.6 million people had enrolled in ACA plans through Jan. 4, 2025, according to a report from a year ago.
    • “Of that total, the Centers for Medicare & Medicaid Services said 2.8 million individuals are new enrollees, while nearly 20 million are returning customers. Close to 15.6 million people signed up for coverage through Healthcare.gov, and 7.2 million used a state-based exchange, according to the report.
  • Beckers Payer Issues provides us with eleven No Surprises Act updates.
  • BenefitsLink calls our attention to a November 2025 IRS notice that provides for inflation adjustments to qualifying payment amounts issued in 2026 under the No Surprises Act. According to BenefitsLink, the notice was not well publicized.
  • Milliman assesses “Medicare drug price negotiation: Navigating the next wave of maximum fair prices.”
  • BioPharma Dive adds,
    • AbbVie is the latest among more than a dozen of the world’s largest drugmakers to sign a drug pricing deal with the White House, announcing late Monday a deal to invest $100 billion in U.S. pharmaceutical research and manufacturing and lower some product costs in return for tariff relief. 
    • As with the many other deals revealed between the Trump administration and large pharma companies, the agreement is short on details as well as its potential impact on AbbVie’s earnings. AbbVie only said that it will provide “low prices” to Medicaid and boost efforts to sell through a government portal widely used medicines like Humira, Alphagan, Combigan and Synthroid — all of which are off-patent and face competition from lower-cost biosimilars or generics. 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, gold standard science, and diverse expertise in guiding the nation’s immunization policies. In June 2025, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
    • The new members are Adam Urato, MD, and Kimberly Biss, MD.
  • MedPage Today offers backgrounds on the new members.
  • Federal News Network notes that “A sea of challenges opens up with 105,000 feds retiring.”
    • “The one-year drop in the number of GS-14s and GS-15s across government is causing some to be concerned about the future of federal management.”

From the Food and Drug Administration front,

  • MedTech Dive points out,
    • “Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect its smart insulin pens with a glucose sensor made by Abbott.
    • “The app, called MiniMed Go, provides alerts for missed insulin doses, a dose calculator and guidance on what to do if a person misses a dose. It also includes software reporting for providers.
    • “The pairing is part of a partnership Medtronic struck in 2024 for Abbott to make an integrated continuous glucose monitor sold exclusively by Medtronic.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The five-year survival rate for all cancers in the U.S. has reached 70% for the first time, according to a report published Jan. 13 by the American Cancer Society. The study analyzed diagnosed cases of cancer in the U.S. from 2015-2021. Among the findings, the study said that since the mid-1990s, there have been notable gains in the survival rates for more fatal cancers, such as myeloma (from 32% to 62%), liver (7% to 22%) and lung cancers (15% to 28%). The cancer mortality rate declined by a total of 34% since peaking in 1991, averting 4.8 million deaths since then.”
  • and
    • “A study released Jan. 12 by the Journal of the American College of Cardiology analyzed the current state of heart health in the U.S., highlighting the burden of disease, quality of care and mortality trends of risk factors and conditions that can lead to heart disease. The study found no change in the prevalence of hypertension among U.S. adults from 2009-2023 but found that hypertension-related cardiovascular deaths nearly doubled from 23 per 100,000 in 2000 to 43 per 100,000 in 2019. The prevalence of diabetes in U.S. adults increased from 11.9% in 2009-2010 to 14.1% in 2021-2023. Deaths related to type 2 diabetes increased from 30.4 per 100,000 adults in 2009 to 54 per 100,000 adults in 2023. The study analyzed other risk factors and conditions such as obesity, cigarette smoking and stroke, among others.”
  • STAT News adds,
    • “46% of U.S. counties don’t have a cardiologist. ARPA-H’s new agentic AI program could bring them specialized care.”
      • “The Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program will support the development of Food and Drug Administration-authorized full-stack solutions that use agentic artificial intelligence to autonomously provide specialty care for every American living with advanced heart disease.”
  • The Washington Post explains how to know when to keep your kids out of school.
  • Per Genetic Engineering and BioTechnology News,
    • “Tahoe Therapeutics, Arc Institute, and Biohub have each made a multi-million dollar commitment to fill the massive data gap for virtual cell models. The teams exclusively told GEN Edge that more than 120 million single cell data points across 225,0000 perturbations will be generated using Tahoe’s Mosaic technology for mapping how drug molecules interact with biology.
    • “All three organizations lead a field that builds AI models trained on transcriptome data to predict how cell gene expression changes with cell states. In therapeutics, these virtual cells could gleam insight into new drugs capable of shifting cells from “diseased” to “healthy” with fewer off target effects.” 

From the J.P. Morgan Healthcare Conference,

  • Healthcare Dive reports
    • “JPM26: Dr. Oz, CMS leaders make their pitch to hospitals, payers on Trump admin healthcare policies.
  • and
    • “JPM26: CommonSpirit CEO teases new divestures, outlines AI wins and pitfalls”
  • Fierce Pharma offers a potpourri of biopharma stories from day 2.
  • STAT News adds,
    • It will be hard for OpenEvidence to top its 2025. The company announced nearly $500 million in funding last year and seemingly overnight became a go-to tool in the medical profession. A slide during the company’s Monday JPM presentation claims that queries to the company’s clinical evidence chatbot grew from 2.6 million in 2024 to 17.9 million in December 2025, with well over 100 million queries for the year.
    • “The company also revealed it will be launching “medical super-intelligence.” What does that mean? Katie Palmer explains in a new story.”

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

  • Beckers Hospital Review reports,
    • San Antonio-based University Health is investing $1.7 billion in a five-year expansion, including two new community hospitals and two multispecialty clinics.
  • and
    • “Skilled nursing facility operating capacity dropped by 5% in the U.S. between 2019 and 2024, according to a study published Jan. 12 in JAMA Internal Medicine.” 
  • STAT New relates,
    • “Illumina became a genomics juggernaut by developing machines that could read large amounts of DNA accurately and quickly. But the company’s betting the next phase of its growth will be accelerated by helping customers better understand genetic data and apply it to drug development.
    • “The San Diego firm took a step in that direction on Tuesday, when it unveiled what it says will be the world’s largest dataset of its kind, the Billion Cell Atlas. The atlas is based on the results of turning on or off genes across 200 cell lines, including lines used to study heart disease, neurologic disorders, immune conditions, and cancer.”
    • “Data on how these genetic perturbations affect cells could in principle help drug companies validate drug targets or create “virtual cells,” artificial intelligence-powered models of cell behavior. Thus far, Illumina has generated data from about 150 million cells and expects to reach a billion by the end of the year. The company’s already offering the atlas as a resource for pharmaceutical companies, with Merck, AstraZeneca, and Eli Lilly as its first customers. Several others have expressed interest, too, according to CEO Jacob Thaysen.”
  • Per MedCity News,
    • “If there’s any single company that understands or should understand the value of health data and its importance in patients’ lives, it’s Wisconsin-based EHR company Epic.
    • “And yet, while the company announced a whole host of future AI efforts last August, including a digital companion for patients called Emmie, it was OpenAI — which announced ChatGPT Health last week — that has actually given people the power to query their medical records and gain insights. Anthropic is announcing a similar capability for Pro and Max users of its Claude generative AI platform. Like Epic, other companies that demonstrated an understanding of that broad patient need also missed the boat.
    • “But in an interview on Friday, Epic’s chief medical officer pushed back on the notion that this was a “missed opportunity” for the EHR company.
    • “I would categorize it, instead of a missed opportunity, as thoughtfully developed over multiple years on top of other non-AI MyChart development and AI that’s actually going to be more thoughtful and tuned to your medical history and your personal medical care,” declared Dr. Jackie Gerhart, also a practicing family physician and vice president of clinical informatics.
    • “Gerhart, who has been with Epic for seven years, and another Epic R&D expert took some pains to describe how the company is developing the capabilities of Emmie, the digital concierge, deeply embedded within the EHR and able to not only handle simple queries like “create an exercise plan”or “explain my lab results” but also nudge you to do the things that you should do for better health.”