Friday report

CMS

Friday report

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

From Washington DC,

  • Here is a link to today’s Secrets of OPM blog post by OPM Director Scott Kupor.
  • Here are links to Fedweek and Fedsmith articles about OPM’s 2026 government contribution announcement made yesterday.
  • Yesterday, the FEHBlog posted the Internal Revenues Service’s 2026 inflation adjusted amounts.
    • The Wall Street Journal discusses how the adjustments impact federal income taxation.
    • Newfront discusses how the adjustments impact employee benefits.
  • Healthcare Dive notes,
    • “Average Medicare Advantage star ratings for 2026 are essentially flat after a few consecutive years of declines — a good sign for the industry, which had braced itself for lower quality scores.
    • “Still, there was variation in major insurers’ results. The percentage of members in plans rated 4 stars or above, an important cutoff for payers, stayed stable for UnitedHealthcare, dropped for Humana and Aetna, and improved for Elevance and Centene — the five largest publicly traded payers in the privatized Medicare program.
    • “Perhaps the biggest loser is Clover Health. The insurer’s largest contract covering almost all of its MA members dropped below 4 stars — a slip that could cost Clover tens of millions of dollars in earnings, analysts estimate.”
  • The American Hospital Association News tells us,
    • “The federal government shutdown is expected to continue into next week as the Senate adjourned Oct. 9 after failing to pass spending legislation; senators plan to return Oct. 14. Meanwhile, the House currently has no plans to return to session next week. The Senate Oct. 9 failed to adopt the House-passed continuing resolution to fund the government following a seventh vote on the bill. Senate Republicans and Democrats have yet to begin formal negotiations toward a deal.”
  • Federal News Network points out,
    • “Hundreds of thousands of federal employees are set to receive reduced paychecks, now on day 10 of the partial government shutdown.
    • “While most civilian federal employees are expected to get their paychecks sometime in the next couple days, they’ll only take home the pay they earned up until the shutdown began. Regardless of whether they are excepted or furloughed, federal employees will not be paid for any days worked between Oct. 1 and Oct. 4 — the final few days of the most recent two-week pay period.
    • “With the partial paychecks, many federal employees will lose out on hundreds of dollars. The exact timing of when employees receive their paychecks depends on their agency, but many began going out Friday.
    • “It’s also the last paycheck excepted and furloughed employees will receive until the government shutdown ends. The first fully missed paycheck, if the shutdown continues, will be for the pay period of Oct. 5 through Oct. 18. Only federal employees who are considered “exempt” from the shutdown will continue to be paid as usual.”
  • Roll Call reports,
    • ​”The Trump administration made good on its threat to begin mass firings of federal civilian employees Friday while exploring creative avenues to make sure military personnel don’t miss their paychecks slotted to go out next week.
    • “With no end in sight to the partial government shutdown that began 10 days ago, White House budget director Russ Vought announced on X that he has begun executing mass layoffs across federal agencies.
    • “An Office of Management and Budget official said the layoffs are “substantial,” without elaborating. Details began trickling out ahead of a court-ordered deadline by close of business Friday, however, hitting numerous agencies including Treasury, EPA, Homeland Security, Education, and Housing and Urban Development, among others.
    • “Speaker Mike Johnson, R-La., meanwhile, officially canceled votes in the House next week, meaning there is virtually no chance that Congress could pass a stand-alone bill to provide pay to some 2 million troops whose next paycheck is due Oct. 15.
    • “But in keeping with President Donald Trump’s pledges to “take care of” the military while punishing “Democrat agencies,” his administration is looking at how to make sure the troops are kept whole financially. A senior White House official said the administration is “exploring every legal maneuver and option at our disposal to get our troops paid during the Democrat Shutdown.” 
  • STAT News informs us,
    • “The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants. 
    • “The BIOSECURE Act, which was passed as an amendment to the National Defense Authorization Act, has been a long time coming. A more aggressive version of the bill was introduced in the Senate in December 2023. The House proposed similar legislation the next month.
    • “BIOSECURE is not over the finish line yet, but it’s significant that the Senate included it in the National Defense Authorization Act, because the defense budget bill has passed every year for decades. The House passed its version of the defense bill earlier in the year without the BIOSECURE Act, so the two chambers would need to agree to include BIOSECURE in the final version of the defense budget bill when reconciling differences between their versions of it.”
  • The AHA News adds,
    • “The AHA discussed ways hospitals and health systems are leveraging artificial intelligence for care delivery in a statement submitted to the Senate Committee on Health, Education, Labor and Pensions for a hearing held Oct. 9 titled, “AI’s Potential to Support Patients, Workers, Children, and Families.” The AHA highlighted examples of AI applications in hospitals, such as diagnostic imaging, ambient listening tools and scheduling for patients and staff.
    • “Hospitals recognize that AI tools hold tremendous promise to alleviate administrative burden and enhance clinical care,” the AHA wrote. “Among other benefits, these innovations can improve workflow, enhance the overall patient experience by reducing wait times and support timely medical interventions.”
    • “The AHA also discussed potential risks of AI in health care, such as commercial insurers using it to determine disposition of claims and prior authorizations, which has exacerbated inappropriate denials. The AHA advocated for the use of clinicians to independently review care recommendations.”
  • The University of Minnesota’s CIDRAP relates,
    • “A federal vaccine advisory group has established a panel to review the safety and efficacy of the childhood immunization schedule, according to a document posted yesterday on the Centers for Disease Control and Prevention (CDC) website.
    • “The Childhood and Adolescent Immunization Schedule Workgroup (WG), established within the CDC’s Advisory Committee on Immunization Practices (ACIP), will review data and “clinical and scientific knowledge” and present its findings to help ACIP members make policy recommendations. 
    • “As part of ACIP’s core mission to develop recommendations on the use of vaccines in the civilian population of the United States, the committee is standing up a WG focused on assessing the safety and effectiveness of the childhood and adolescent schedule,” the document states.
    • “Among the topics the group will review are the timing and order of different childhood vaccines, administering different vaccines at the same time, the safety of certain vaccine ingredients, and the different childhood vaccine schedules used in other countries.”

From the Food and Drug Administration front,

  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved another new treatment option for heart-failure related edema. 
    • “Just weeks after its approval of bumetanide nasal spray for the treating edema associated with congestive heart failure, kidney disease and liver disease, the agency has given the greenlight to Lasix ONYU, a new drug-device combination from SQ Innovation, for adult patients with chronic heart failure. 
    • “Lasix ONYU provides patients with injections of a high-concentration formulation of furosemide. The injections are delivered with a small two-in-one device. While the base of the device is reusable, only to be replaced after 48 treatments, the other part of the device is used once and then discarded. According to SQ Innovation, this new-look design helps ensure the delivery device can be manufactured at a low enough price point so the treatment remains affordable.
    • “In one recent analysis published in European Heart Journal – Cardiovascular Pharmacotherapy, researchers found that the Lasix ONYU technology was linked to a bioavailability similar to receiving furosemide through an IV. Treatment was also confirmed to be “feasible and well tolerated.”

From the. public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention is not updating its respiratory illnesses data channel during the shutdown.
  • Dr. Tom Friden, a former CDC Director, writes in the Wall Street Journal about the simple steps that can prevent dementia.
    • “When it comes to healthy aging, personal responsibility matters. But American healthcare also suffers from systemic failures. Despite spending more than $4 trillion annually, we get the most important things, such as blood pressure control, right at most half the time. Our system doesn’t incentivize doctors to deliver the preventive care that matters most. For instance, they are paid little or nothing for making an effort to control a patient’s blood pressure.
    • “The tools for a healthy, dementia-free future exist: blood pressure control, appropriate statin and other therapy, smoking prevention and cessation support, and comprehensive primary care focused on prevention. We need a healthcare system that delivers them reliably, for all our sakes.”
  • Per Health Day,
    • “Heart-related health problems might affect as many as 1 in 7 pregnancies, even among women without any prior heart disease, a new study says.
    • “Researchers found a steady increase in heart-related health problems among more than 56,000 pregnancies between 2001 and 2019 in New England.
    • “Heart attack, stroke, heart failure, blood clots, high blood pressure and heart-related maternal death affected about 15% of pregnancies during that time, researchers reported Oct. 6 in the journal Circulation.
    • “Our findings showcase an alarming trend of rising real-world burden of pregnancy-related cardiovascular complications and highlights pregnancy from preconception to the postpartum period as a crucial window of opportunity to implement primary prevention strategies and optimize cardiovascular health,” concluded a team led by Dr. Emily Lau, a cardiologist at Massachusetts General Hospital in Boston.”
  • Per MedPage Today,
    • “New-onset atrial fibrillation (Afib or AF) was surprisingly common after coronary artery bypass grafting (CABG), but its burden quickly diminished to near zero after 30 days, according to long-term continuous ECG monitoring data.
    • “With a monitor implanted during surgery, patients at two German centers showed a 48% incidence of new-onset Afib in the first year after CABG, with a median Afib burden of 0.07% (or 370 minutes).
    • “It turned out that on days 1-7, the median Afib burden was 3.65% (368 minutes), dropping quickly thereafter to 0.04% (13 minutes) on days 8-30 and 0% (0 minutes) on days 31-365, according to researchers led by Florian Herrmann, MD, of LMU University Hospital in Munich, Germany.
    • “Although the incidence of new-onset AF after CABG in this study was higher than previously reported, the AF burden in these patients was very low, especially after 30 days,” the authors reported in JAMA.
    • “This low burden calls into question whether long-term oral anticoagulation is necessary in patients with new-onset AF after CABG. The very low burden provides a likely explanation for why observational studies have failed to demonstrate reduced stroke rates with oral anticoagulation in this patient group,” Herrmann’s group suggested.”
  • Per the American Journal of Managed Care,
    • “A smartphone app significantly reduced depressive symptoms and improved self-esteem and quality of life in individuals with intellectual disabilities.
    • “The study addressed a research gap, highlighting the app’s potential as an accessible mental health intervention for an underserved population.
    • “Limitations include self-reported data, potential bias, and lack of long-term follow-up, affecting the generalizability of results.
    • “Future research should explore optimal app use, caregiver involvement, and accessibility barriers to enhance mental health support for individuals with IDs.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “AstraZeneca is the latest major drugmaker to agree to a deal with the Trump administration on lowering the prices of its drugs, some of which will be available for purchase through a government website next year, President Trump said Friday. 
    • “The agreement, which entails offering “most-favored nation” drug pricing, follows Pfizer’s deal to reduce prices for its drugs sold in the Medicaid program and through a new direct-purchasing service to be branded TrumpRx.
    • “AstraZeneca will similarly offer all prescription drugs on the government website, TrumpRx, which the administration said it will launch in 2026, said Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services.
    • “In addition to the lower drug prices for people on Medicaid, all new AstraZeneca drugs introduced to the market will be launched at most-favored nation pricing, which is tied to comparable prices in other wealthy nations.” 
  • Reuters adds,
    • “Retail pharmacies and prescription drug savings site GoodRx (GDRX.O)
      are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies’ direct discounts.” * * *
    • “The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco (COST.O), said they were also talking with administration officials.”
  • The Wall Street Journal also lets us know,
    • “Johnson & Johnson JNJ is in talks to buy Protagonist Therapeutics in a deal that would solidify the companies’ existing partnership, according to people familiar with the matter.
    • “A deal is not guaranteed and the exact details being discussed couldn’t be learned, the people said. 
    • “Protagonist had a market value of over $4 billion as of Thursday’s close. Including a typical premium, a deal would likely value the company well above that. 
    • “”J&J is already working with Protagonist to develop an oral treatment for immune diseases including plaque psoriasis and ulcerative colitis and has the exclusive rights to commercialize the product. It already owns close to 4% of Protagonist’s shares, according to FactSet.
    • “By acquiring Protagonist, the healthcare conglomerate would also gain access to the drug rusfertide, from Protagonist and partner Takeda Pharmaceutical4502 -2.63%decrease; red down pointing triangle. Rusfertide has shown promise in late-stage testing in treating a rare blood cancer called polycythemia vera. 
    • “Both assets would complement J&J’s portfolio of immune and cancer drugs.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is joining big pharma’s rush into “in vivo” cell therapies, paying $1.5 billion to acquire Orbital Therapeutics for a technology designed to rewire the immune systems of people with inflammatory conditions.
    • “The deal announced Friday gives Bristol Myers ownership of a company that’s been working on ways to genetically modify immune cells inside the body. Orbital’s lead program, OTX-201, does so by sending into cells “circular” RNA instructions training them to seek out cells with a particular protein flag. OTX-201, which is envisioned as an autoimmune disease treatment, could begin human testing next year.
    • “The acquisition expands Bristol Myers’ presence in cell therapies. The company is already one of the field’s leaders, with multiple marketed medicines for blood cancers. But, like its peers, Bristol views autoimmune disorders as a way to potentially broaden use of the complex treatments.”
  • Per MedTech Dive,
    • “Zimmer Biomet has launched two orthopedic devices with Paragon 28, the foot and ankle specialist it bought for $1.1 billion early this year. 
    • “The new products, which Zimmer reported Wednesday, add treatments for a type of shinbone break and hindfoot injuries to the company’s portfolio.
    • “Introducing the devices continues Zimmer’s efforts to maintain Paragon’s double-digit growth and expand its sports medicine, extremities and trauma (SET) business.”
  • The Employee Benefits Research Institute released its 2025 Employer Mental Health Survey.
  • Fierce Healthcare adds,
    • “Most employers offer coverage for mental health services, but where they fall short is in tracking whether those benefits are working, according to a new survey.
    • “The report, conducted by the Employee Benefit Research Institute (EBRI), found that 97% of employers offer mental health coverage and 67% offer coverage for substance abuse treatment. However, only 22% said they actively monitor whether employees are using the benefits.
    • “In addition, there is a significant opportunity for employers to do more in tracking network adequacy, the study found. Forty-seven percent of those surveyed said they receive details from vendors or collect data on provider-to-enrollee ratios, while 44% said they track employees’ distance to providers and 48% said they monitor wait times.
    • “Fewer than one-third (31%) said they collect data on out-of-network care use, which is a major barrier to behavioral health access, per the report.”
  • KFF-Peterson Health System Tracker studies “how much do people with employer plans spend out-of-pocket on cost-sharing?”
    • “By cost-sharing type, average spending on deductibles and coinsurance has increased, while copayments have remained flat relative to inflation since 2013. However, since 2021, inflation (16%) and spending on deductibles (13%) have grown at similar rates. Deductibles rose rapidly before 2019, however starting in about 2019 employers have held deductibles constant.
    • “In 2023, 66% of people with employer coverage spent at least $100 on out-of-pocket health care expenses. Among them, 39.7% spent between $100 and $999 on average, while 26% spent $1,000 or more. Over time, the share of enrollees facing over $1,000 in annual out-of-pocket costs has steadily increased.  Conversely, 18% of people with employer coverage incurred no out-of-pocket costs, and 15.4% spent less than $100 in 2023.
    • “Regarding total health spending, 56% of people with employer coverage spent $1,000 or more, including 41% who spent between $1,000 and $9,999 and 15% who spent $10,000 or more. Meanwhile, 12% of enrollees used no health care billed to their health plan in the year, which further highlights the uneven distribution of health care costs across the insured population under employer plans.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Health Economics Methods Advisory (HEMA) yesterday released its first ever Draft Report focused on the assessment of the benefits of treatment that are appropriate to consider in economic evaluation for health technology assessment (HTA) decision-making.
    • “HEMA has been convened by the leaders of three global HTA organizations to independently assess new methods and processes. The three institutions include ICER, England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC).
    • “This draft report will be open for public comment until October 30, 2025, providing a unique opportunity for all stakeholders to engage in the report development process.
    • “If you are interested in submitting a public comment on the Draft Report, visit https://hemamethods.org/our-research/.”

Thursday Report — 2026 Government Contributions Announced

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

From Washington, DC,

  • Federal News Network informs us,
    • “Federal employees and annuitants are heading for yet another year of large increases to their health insurance premiums, in both the Federal Employees Health Benefits (FEHB) program and the Postal Service Health Benefits (PSHB) program.
    • “The Office of Personnel Management announced Thursday that FEHB participants will pay an average of 12.3% more toward their insurance premiums starting in January 2026 — or in dollars, an average of $26.40 more per pay period.
    • “The upcoming 12.3% premium spike follows multiple large premium increases over the last few years for FEHB enrollees. Federal employees saw an average of a 13.5% increase for the 2025 plan year — the largest year-over-year increase in well over a decade. Feds also saw a 7.7% jump in 2024, and an 8.7% increase in 2023.
    • “The PSHB program, which is open to more than 2 million USPS employees, annuitants and family members, is also set for a large premium increase for 2026. Enrollees in PSHB will be paying 11.3% more, on average, toward their 2026 premiums. In dollars, that’s about $21.51 more per pay period.” * * *
    • “When accounting for the government’s share of FEHB costs, which is increasing by about 9.2%, premiums will rise by 10.2% overall. PSHB premiums are increasing by 9% overall, when including the government’s portion of the cost, which is going up by 8%.”
  • Per an OPM news release,
    • “Today, the Office of Personnel Management (OPM) announced the 2025 Federal Benefits Open Season will be held from November 10 through December 8, 2025, and the 2026 plans and premiums for Federal Employees Health Benefits (FEHB) Program, Postal Service Health Benefits (PSHB) Program, and Federal Employees Dental and Vision Insurance Program (FEDVIP) are now available for review
    • “This is the opportunity for eligible federal and postal employees and annuitants to enroll or make changes to their health, dental, and vision coverage for the upcoming year.
    • “During Open Season, we want to give enrollees the opportunity to review their coverage, compare coverage options, and make the choice that is right for them,” Associate Director for Healthcare and Insurance Shane Stevens said. “I strongly encourage all employees to reassess their current coverage and choose the plans that best meet their family’s needs.” * * *
    • “Read Associate Director Stevens’ blog post about this year’s Open Season here. Read how to prepare for Open Season here.”
  • Here is a link to Govexec’s article about the OPM announcement.
  • Modern Healthcare reports,
    • “Medicare Advantage insurers suffered another disappointing year under the Star Ratings quality measurement program. 
    • “The average Medicare Advantage star rating for 2026 is essentially flat at 3.66, compared with 3.65 for 2025, according to data the Centers for Medicare and Medicaid Services released Thursday.
    • “Just over four in 10 Medicare Advantage contracts — which are bundles of plans — earned at least four of five stars, the threshold to qualify for the maximum 5% bonus payment, the same as this year. Eighteen contracts, or 3.5%, won five stars, up from seven for 2025. The annual enrollment period begins next Wednesday and ends Dec. 7.”
  • The Wall Street Journal reports.
    • “Republican and Democratic senators are trading ideas on healthcare funding to forge a path out of the government shutdown, as tensions rose on Capitol Hill ahead of what is set to be a painful week for government workers and military servicemembers.
    • “Informal discussions have centered on extending enhanced Affordable Care Act subsidies temporarily, but with new guardrails meant to cut back on aid for higher-income families. One cutoff point that has been discussed among Democrats: limiting the subsidies to households at or below $200,000 of income, rather than leaving the benefit uncapped.
    • “Sen. Angus King (I., Maine), who caucuses with the Democrats, has dubbed his approach the “two and two”—a two-year extension of the subsidy capped at $200,000 of income. Sen. Mark Kelly (D., Ariz.) said that a cap would be hard to implement this year, but that discussions were occurring about reducing the subsidy for next year by limiting the benefit to people making above a certain percentage of the federal poverty line, with some members aiming for a cap at $200,000 of household income.” * * *
    • “The government shutdown started Oct. 1, and many federal workers and troops are set to miss their first full paychecks next week.”
  • and
    • “The Trump administration said it isn’t planning to impose tariffs on generic drugs from foreign countries, after months of wrangling over whether to impose levies on the vast majority of drugs that are dispensed in the U.S.
    • “The administration has been weighing duties on a range of pharmaceutical products and ingredients, using a tariff investigation under Section 232 of the Trade Expansion Act of 1962, which covers threats to national security. President Trump last month posted online that he would impose 100% tariffs on name-brand drugs on Oct. 1 but didn’t mention generics. Trump ultimately delayed imposing tariffs, as officials said they would allow for more negotiations with drug companies.
    • “The administration is not actively discussing imposing Section 232 tariffs against generic pharmaceuticals,” White House spokesman Kush Desai said in a statement. A spokesman for the Commerce Department, which is handling the tariff investigation, similarly said that the 232 investigation wouldn’t result in tariffs on generics.
    • “The move, which isn’t final and could change in the coming weeks, comes after months of debate within the administration over how to bring manufacturing of generic drugs back to the U.S. and what role tariffs should play in that effort.”
  • The Internal Revenue Service helpfully posted a revenue procedure that “sets forth inflation-adjusted items for 2026 for various Code provisions as in effect on October 9, 2025.”
  • Beckers Clinical Leadership informs us,
    • “The federal government has directed the United Network for Organ Sharing to pause some of its oversight work amid the government shutdown.
    • “As the primary contractor for the Organ Procurement and Transplantation Network, UNOS manages the nation’s donation and transplant system, facilitating matches and monitoring patient outcomes.
    • “While critical services — including operation of the organ matching system and responding to serious patient safety risks — will continue, the OPTN has been ordered to pause much of its routine oversight responsibilities. As a result, many committee meetings have been canceled, a UNOS spokesperson told Becker’s. One specific area of work being paused is the monitoring of reports for policy implementation on heart and lung transplants. 
  • MedCity News discusses the application of the White House’s artificial intelligence action plan to healthcare.
    • “Healthcare and life sciences are about to face unprecedented AI-driven regulatory changes that will reshape everything from research and development to drug approval submissions. Here are 10 steps healthcare and life sciences organizations should take to strategically prepare.”
  • Bloomberg Law relates,
    • “The US Centers for Disease Control and Prevention will reschedule a late October meeting of an influential vaccine panel that’s been weighing changes to long-standing advice around childhood shots.
    • “The Advisory Committee of Immunization Practices, or ACIP, will no longer meet on Oct. 22 and 23, according to the panel’s website. No indication was given of when a future meeting will take place or why it was moved. 
    • “A US Department of Health and Human Services spokesperson said the meeting details would be posted online once they are finalized. ACIP typically only meets three times a year, though the upcoming October meeting was set to be its fourth gathering in 2025.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “In 2022, Regeneron paid Sanofi $900 million to gain full rights to its partnered cancer drug Libtayo. Three years later, the pricey bet on the injected PD-1 inhibitor appears to be paying off.
    • “Thursday, the FDA approved Libtayo as the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC). The nod applies to patients who are at a high risk of recurrence after surgery and radiation.”
    • “The green light comes seven years after Libtayo became the first drug to reach the market in CSCC, as it was endorsed for patients with metastatic CSCC or those with locally advanced CSCC who are not candidates for surgery or curative radiation.”
  • Per Cardiovascular Business,
    • “San Francisco-based Bunkerhill Health has received U.S. Food and Drug Administration (FDA) clearance for its new advanced artificial intelligence (AI) algorithm designed to detect and evaluate mitral annular calcification (MAC) on routine, non-gated CT scans.
    • “According to Bunkerhill Health, the AI model—known as Bunkerhill MAC—is the first AI model cleared by the FDA to identify signs of MAC, a known cardiovascular disease risk factor. It was developed and tested using data from more than 25 academic medical centers.
    • “MAC may be missed on imaging, but it carries prognostic value for cardiovascular risk and procedural outcomes,” Alexander Sandhu, MD, MS, assistant professor in the division of cardiology at Stanford University School of Medicine, said in a statement. Stanford is one of the schools that provided data for the development of Bunkerhill MAC. “A tool that can automatically identify and quantify MAC on routine chest CT scans gives us a way to capture this information consistently and at scale, which could help guide decision-making and research across cardiology and structural heart care.”

From the public health and medical / Rx research front,

  • Politico reports,
    • “The CDC and its independent panel of vaccine advisers have quietly opened the door to wider access to Covid-19 vaccination during pregnancy, softening an earlier decision by Health Secretary Robert F. Kennedy Jr. to stop recommending that pregnant women get the shots.
    • “The CDC’s Advisory Committee on Immunization Practices voted in September to advise that adults get the Covid-19 shot through shared clinical decision-making between patients and providers. It did not specifically vote on whether the shot should be administered during pregnancy, yet the vote appears to encompass pregnant women, according to an update this month on the CDC website that reflects the new guidance.
    • “The new guidance for adults means that pharmacies can administer the vaccine to pregnant women and almost all insurers must cover the shots with no cost sharing — expanding access.”
  • Cardiovascular Business tells us,
    • “Transcatheter aortic valve replacement (TAVR) is being used to treat a rising number of patients with severe aortic stenosis. However, according to a new commentary published in the Journal of the American College of Cardiology (JACC), this trend may have gone too far.[1] The authors fear that too many low-risk patients are undergoing TAVR when they should be considered for surgical aortic valve replacement (SAVR) instead.[1] 
    • “With some U.S. states documenting that nearly 50% of patients requiring aortic valve replacement aged <65 years receive TAVR rather than guideline-directed SAVR, a significant public health concern may be looming,” wrote first author J. Hunter Mehaffey, MD, MSc, a cardiac surgeon with West Virginia University (WVU), and colleagues. “While we await long-term data from trials, there are growing questions surrounding valve durability and reintervention rates, particularly in younger and lower-risk populations. These concerns include the potential deleterious effects of accelerated structural valve deterioration, and the commensurate rise in the need for premature surgical TAVR explantation.”
    • “Mehaffey et al. emphasized that the risks associated with SAVR are typically procedural. With TAVR, however, some risks persist for up to two years after treatment. In addition, the group added, many patients who care teams treat on a daily basis were excluded from the initial studies used to track the safety and effectiveness of TAVR in low-risk patients. This creates uncertainty about whether or not a patient with a bicuspid aortic valve, for example, should be treated with TAVR over SAVR.”
  • Healthcare Dive adds,
    • “Hospitals charged Medicare more than $1.9 billion over three years for more than 200,000 unnecessary, “low-value” back surgeries for older adults, according to a new analysis of claims data from the Lown Institute.
    • “That amounts to one unnecessary back procedure every eight minutes, according to the report, which analyzed the rates of spinal fusions and vertebroplasties — or surgeries that inject medical-grade cement into broken spinal bones to relieve pain.
    • “Back surgeries have come under scrutiny due to the high risk of complications — including including infection, blood clots and strokes — which can occur in up to 18% of patients, according to the report. “Reducing unnecessary procedures, particularly invasive ones that carry grave risks, is a moral imperative,” Dr. Vikas Saini, president of Lown, said in a statement.”
  • The New York Times relates,
    • “Surgeons in China have for the first time transplanted a section of liver extracted from a genetically modified pig into a human cancer patient, they reported on Thursday.
    • “The surgeons, who described the procedure in a paper in The Journal of Hepatology, grafted the portion of pig liver onto the left lobe of a 71-year-old patient’s liver after removing the larger right lobe, where a tumor the size of a grapefruit had grown. The lobe with the porcine transplant functioned, producing bile and synthesizing blood clotting factors, the surgeons reported. The patient’s body did not reject the organ graft, which enabled the remaining left lobe of the patient’s own liver to regenerate and grow, the scientists said.
    • “The porcine liver lobe was removed 38 days after the transplant, when complications developed, the surgeons wrote in the report. The patient, who had advanced disease, died a little over five and a half months later. He would not have been eligible to receive a human donor organ in China because he had advanced cancer and hepatitis B-related cirrhosis, the authors wrote.”
  • NBC News lets us know,
    • “Just as a single night of insomnia may leave you feeling groggy and cranky, solid slumber can help you feel rested and ready to take on the day. How well you sleep over time, however, can influence deeper aspects of your health and well-being, new research shows.
    • “Five distinct sleep patterns are tied to your health, lifestyle and cognition and even how different regions of your brain connect to one another, according to a study published Tuesday in the journal PLOS Biology. 
    • “Specifically, those “sleep-biopsychosocial profiles” encompass biological, psychological and socioenvironmental factors — such as having a safe, comfortable place to sleep — that contribute to your sleep hygiene.”
  • Per Health Day,
    • “A rare but dangerous form of breast cancer is on the rise in the United States, a new report says.
    • “Lobular breast cancer rates are rising three times as fast as all other breast cancers combined, 2.8% per year versus 0.8% per year, researchers reported Oct. 7 in the journal Cancer.
    • “Although lobular breast cancer accounts for a little over 10% of all breast cancers, the sheer number of new diagnoses each year makes this disease important to understand,” said lead researcher Angela Giaquinto, an associate scientist for cancer surveillance research at the American Cancer Society (ACS).
    • “Also, survival rates beyond seven years are significantly lower for (lobular breast cancer) than the most common type of breast cancer, highlighting the pressing need for prevention and early detection strategies targeting this subtype to be brought to the forefront,” Giaquinto added in a news release.
    • “Lobular breast cancer develops in the milk-producing glands of the breast, which are called lobules, researchers said in background notes.”
  • and
    • “Concussions and traumatic brain injuries (TBI) have been considered a potential cause of ALS, also known as Lou Gehrig’s disease.
    • “But a new study argues the association might be the other way around, with concussions providing an early warning sign among folks already in the early stages of ALS (amyotrophic lateral sclerosis).
    • “The loss of muscle control that comes with early ALS might increase people’s risk for a concussion-causing fall or accident; researchers write in JAMA Network Open.
    • “If that’s so, then “TBI in some individuals perhaps (reflects) a consequence of early, subclinical ALS,” concluded the research team led by Dr. William Stewart, a neuropathologist at Queen Elizabeth University Hospital in Glasgow, U.K.”
  • The FEHBlog recalls reading that Lou Gehrig suffered a lot of concussions as a baseball player in the days before batting helmets.

From the U.S. healthcare business front,

  • Fierce Pharma relates,
    • “AstraZeneca has broken ground on a $4.5 billion manufacturing facility near Charlottesville, Virginia, confirming a report about its location six weeks ago when state lawmakers approved an economic development package for the project.
    • “The company has added an additional $500 million to its original planned investment in the site, which will manufacture active pharmaceutical ingredient (API) for the production of weight management, metabolic and cardiovascular treatments, along with drugs from AZ’s growing antibody-drug conjugate (ADC) portfolio.
    • “AZ plans to create 600 full-time roles at the site, plus an additional 3,000 jobs during construction of the facility, according to an Oct. 9 press release.  The company expects the plant to come online in the next four to five years.”
  • Bloomberg points out,
    • “UnitedHealth Group Inc. plans to acquire a 45-doctor medical practice in Massachusetts in a sign that its Optum division will keep adding doctors despite turmoil in the business.
    • “The company’s Atrius Health affiliate has agreed to buy a Boston-area primary care group called Acton Medical Associates, PC, according to a notice posted by a Massachusetts regulator.
    • “The deal shows UnitedHealth continues to expand its reach in primary care and physician groups even as that part of its business has struggled. Physician groups are part of its sprawling Optum Health business, where executives said earnings were $6.6 billion below expectations in a July call with analysts.”
  • BioPharma Dive notes,
    • “Novo Nordisk will spend billions of dollars to grow its foothold in treating a common liver condition, agreeing on Thursday to buy Akero Therapeutics for a drug that’s currently in late-stage testing. 
    • “Novo will pay $54 per share, or about $4.7 billion upfront, for California-based Akero and its lead drug, known as efruxifermin. Akero stockholders could see another $6 per share in payouts via a so-called contingent value right if efruxifermin is approved by U.S. regulators.
    • “In buying Akero, Novo is adding to a recent upswing in dealmaking involving drugs for the liver disease known as metabolic dysfunction-associated steatohepatitis, or MASH. GSK bought one prospect from privately held Boston Pharmaceuticals in May, and Roche acquired another through a deal for 89bio last month. All three deals were centered around medicines that mimic the activity of a metabolism-balancing hormone called FGF21.” 
  • Per STAT News,
    • “With a flurry of startup activity, tech to monitor the symptoms of Parkinson’s disease is gaining traction in care.
    • “On Thursday, Kneu Health, a startup spun out of Oxford University research labs, announced $5.6 million in funding for its smartphone app-based platform that measures movement, speech, and cognitive changes in people with Parkinson’s over time. In addition to working with the U.K. National Health Service, Kneu is being trialed by Cedars-Sinai, which is an investor, and Mass General Brigham. It has raised $11.2 million to date.
    • “Over the summer, San Francisco-based Rune Labs quietly raised $11 million from its existing investors with plans to add more funding. The company has raised $57 million total to support its Parkinson’s technology, which uses an Apple Watch to track symptoms and boasts a growing partnership with Kaiser Permanente. Last week, wearable device and algorithm developer Empatica announced it had acquired PKG Health, another maker of Parkinson’s tracking tech that’s been used to care for 35,000 people. Empatica’s largest business is supporting pharma companies.”
  • Per Fierce Healthcare,
    • “Similar to Medicare, commercial insurers are seeing substantially higher prices when care is delivered in a hospital outpatient department as opposed to an ambulatory surgical center, according to a multi-payer analysis published this week.
    • “However, just how much those prices increase varies substantially between individual commercial payers, suggesting there’s more room for insurers to push down spending via selective provider contracting, Brown University researchers wrote in their Health Affairs study.
    • “The researchers said their analysis is unique in focusing on site-based payment differentials across multiple payers in the commercial insurance market, which have largely been overshadowed by investigations and debate over site-neutral payment policies for Medicare.
    • “Although insurers can, and do, pursue strategies to limit payment differentials across settings, large payment differentials remain common and costly,” they wrote in the journal.”
  • and
    • “When the government entered a partial shutdown Oct. 1, hospitals across the country faced a major task: discharging, relocating or shifting care programs for the thousands of patients in hospital at home programs. 
    • “With Congress at a standoff over healthcare cuts and Affordable Care Act premium tax subsidies, the body failed to reauthorize the Centers for Medicare & Medicaid Services’ (CMS’) pandemic-era Acute Hospital Care at Home program, along with Medicare telehealth services.
    • “The CMS directed the 419 participating AHCaH hospitals to discharge or relocate Medicare hospital at home patients if Congress did not extend the waiver. Health systems received the notice about 60 days in advance of the Sept. 30 deadline, and they received periodic reminders as the shutdown drew near. 
    • “In the days before the shutdown, hospitals ramped down admissions to hospital at home programs . Since the lapse of the waiver, home hospital providers have entered a complex maze of regulations and decisions.”
  • The Wall Street Journal reports,
    • “Drug Rehabs Lure in Patients for Insurance Money—Then Leave Them on the Street.”
    • “Operators promise high-end treatment, help addicts sign up for insurance then pile on charges for little in return, say former patients and insurers.:”
  • The FEHBlog observes that’s a big bowl of wrong.

Midweek report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports.
    • “As the government shutdown entered its second week, Democratic lawmakers insisted the tide is shifting toward a deal as some hard-line Republicans express support for extending health insurance subsidies, despite blanket opposition from Republican leadership to any agreement in advance of reopening the government. 
    • “Ending the standoff appears unlikely in the short term — votes aimed at doing so Wednesday yielded similar results as before, with the GOP’s continuing resolution going down for a sixth time, 54-45. The same three Democratic caucus members — Catherine Cortez Masto of Nevada, Angus King of Maine and John Fetterman of Pennsylvania — voted in favor. The Democrats’ continuing resolution was also blocked.
    • “As for the parameters of a potential deal, House Minority Leader Hakeem Jeffries, D-N.Y., once again ruled out a one-year extension of the subsidies. Democrats have called for a permanent extension of the premium tax credits but asked by reporters if a two-year extension was possible, Jeffries didn’t rule it out.”
  • The Wall Street Journal explains who currently gets subsidies in return for receiving coverage under the Affordable Care Act.
  • Because the 2019 shutdown ended due to an air traffic controller walkout, Govexec observes,
    • “The Federal Aviation Administration reported no travel delays due to staffing levels at U.S. air traffic control facilities Wednesday, following a day of some delays related to above-average absences at a handful of facilities.
    • “An FAA operational plan posted about noon Eastern Time on Wednesday, the eighth day of the federal government shutdown, showed no facilities impacted by “staffing triggers.” A day earlier, the same memo showed staffing levels affected operations at major hub airports in Phoenix and Denver, as well as a smaller airport in Burbank, California.
    • “Air traffic controllers are essential to the functioning of the nation’s air transportation system and must continue to work during a shutdown, though they are not paid while it is ongoing.
    • “The group has not yet missed a paycheck during the current lapse in federal funding. The first impact most federal employees will see on their pay will be Friday, when electronic funding transfers are made for the pay period from Sept. 24 to Oct. 7. 
    • “Because Congress has not appropriated money beyond Sept. 30, they would only receive a partial paycheck. Future paychecks would not be allocated until the government reopens.”
  • Per Fierce Healthcare,
    • “The top senator on healthcare policy is taking a hard look at the American Medical Association’s “anti-patient and anti-doctor” handling of the healthcare system’s near-ubiquitous billing and claims processing codes.
    • “Bill Cassidy, M.D., R-Louisiana, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, chastised the nation’s leading physician association for “abusing” the Current Procedural Terminology (CPT) coding system and said he will be “actively reviewing” the issue.
    • “In a letter sent Monday but made public Wednesday, he accused the AMA of “charging exorbitant fees to anyone using the CPT code set, including doctors, hospitals, health plans and health IT vendors. These fees inevitably are passed on by CPT users to patients in the form of higher healthcare costs.”
    • “The letter includes requests for the AMA to detail how it incorporates provider feedback into its process for finalizing codes, and for specific details on revenues and spending related to CPT codes.”
  • The Wall Street Journal relates,
    • “The country’s top drugmakers are set to meet in early December at the Four Seasons hotel in Georgetown with Donald Trump Jr. and senior Trump administration officials that regulate the pharmaceutical industry.
    • “The host: BlinkRx, an online prescription drug delivery company that this year installed Trump Jr. as a board member. The summit will conclude with a dinner at the Executive Branch, the exclusive new club founded by Trump Jr. and his close friends, according to people with knowledge of the event and a copy of the invitation viewed by The Wall Street Journal. 
    • “BlinkRx stands to benefit from a shake-up of how patients buy drugs after President Trump urged pharmaceutical companies to sell their medicines directly to consumers. BlinkRx helps drugmakers do exactly that with a service that promises to set up direct-to-patient sales programs in as little as three weeks. TrumpRx, a new government website set to launch in early 2026, would funnel patients to direct-sale sites.”
  • Healthcare Dive informs us,
    • “The top lobby for pharmacy benefit managers has named Adam Kautzner, the head of major PBM Express Scripts, as chair of its board.
    • “As board chair, Kautzner will oversee the Pharmaceutical Care Management Association’s strategy, including defense of the drug middlemen amid growing scrutiny of their role in rising drug costs. 
    • “The PCMA has also created a new council to represent its mid-market clients, a segment of its membership that’s been growing, the lobby said Tuesday. The council will be represented by a new seat on the PCMA’s board to be held by Jeff Park, president of drug pricing platform Waltz Health.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “More than 10 years after bringing one of the first idiopathic pulmonary fibrosis (IPF) drugs to market, Boehringer Ingelheim is freshening up its leadership in the rare lung disease space with a newly approved treatment option.
    • “Jascayd’s Oct. 7 FDA approval makes it the first new therapy for IPF in more than a decade, following in the footsteps of the company’s own Ofev and Roche’s Esbriet, which won their respective FDA nods back in 2014. Together, those two medicines make up the current therapeutic market for IPF in the U.S. 
    • “With a tolerability edge over the older treatments and proven benefits in lung function, Boehringer’s new option could “shape the future of IPF treatment,” Martin Beck, head of the company’s inflammation disease area, told Fierce Pharma in an interview.”
  • BioPharma Dive adds,
    • “Lexeo Therapeutics on Tuesday said the Food and Drug Administration appears willing to review, and potentially approve, its experimental rare disease gene therapy more quickly than previously anticipated.
    • “According to the company, the agency has “indicated openness” to an accelerated approval filing for its treatment — a gene therapy called LX2006 for the neurodegenerative condition Friedreich’s ataxia — that’s based on pooled data from ongoing studies as well as results from a planned pivotal trial.”

From the judicial front,

  • Reuters reports,
    • “A federal appeals court on Monday rejected Novo Nordisk’s (NOVOb.CO) challenge to the U.S. government’s program that gives its Medicare health insurance plan the power to negotiate lower drug prices, the latest in a barrage of lawsuits brought by drugmakers to fail.
    • “The Philadelphia-based 3rd U.S. Circuit Court of Appeals affirmed a lower court’s ruling dismissing the Danish drugmaker’s challenge to the program and the Centers for Medicare and Medicaid Services’ selection of six of its insulin products for price negotiations.
    • “A unanimous three-judge panel rejected Novo’s constitutional challenges to the program, which was part of Democratic former President Joe Biden’s Inflation Reduction Act, and said the law specifically bars courts from reviewing the drugs selected.
    • “A Novo Nordisk spokesperson said the company was assessing its options to appeal the ruling.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “Today the Centers for Disease Control and Prevention (CDC) updated its measles data for the country, showing a total of 1,563 cases in 2025, an increase in 19 cases since last week. This is the most cases seen in the United States since 2000, the year measles was officially declared eliminated. 
    • “Twenty-seven percent of cases have been in children under the age of 5, and 92% of patients are unvaccinated or have an unknown vaccination status. CDC officials have confirmed 44 outbreaks, which account for 87% of confirmed infections.”
  • and
    • “An international team of researchers today reported promising results from a phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections.
    • “The team, led by investigators from the University of Maryland (UM) School of Medicine, reported that the trivalent (three-strain) Salmonella conjugate vaccine (TSVC) produced a strong immune response, and was safe and well-tolerated, in a small group of healthy US adults. The findings from the trial were published today in Nature Medicine.
    • “The investigators say the findings are encouraging and provide a strong foundation for evaluating the vaccine in children. Typhoid fever and invasive non-typhoidal Salmonella (iNTS), which causes severe bloodstream infections, are leading causes of illness and death in children in Africa.
    • “A single vaccine that protects against both could be a game-changer for global pediatric health,” UM School of Medicine Dean Mark Gladwin, MD, said in a university press release.”
  • MedPage Today notes,
    • “Receipt of the 2024-2025 COVID-19 vaccine was associated with decreased risks of severe outcomes, according to an observational cohort study of U.S. veterans.
    • “Looking at COVID-associated outcomes in nearly 300,000 veterans at 6 months, the estimated vaccine effectiveness was 29.3% against emergency department visits, 39.2% against hospitalizations, and 64% against deaths, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “Overall, vaccine effectiveness for a composite of the three outcomes was 28.3%, with a risk difference per 10,000 people of 18.2 (95% CI 10.7-27.5), they noted in the New England Journal of Medicine.
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
    • “The severity of SARS-CoV-2 infections has waned since 2020, and uncertainty about the value of annual COVID shots helped drive down adult vaccination rates to 21% during the 2024-2025 season.”
  • The Washington Post lets us know how to stop the No. 1 killer of Americans long before any symptoms. Cardiovascular disease experts propose a new approach to treating heart disease, focusing on atherosclerosis prevention and early detection.
    • To improve your heart health, consider following the American Heart Association’s checklist, said Neha Pagidipati, a cardiovascular disease prevention expert with the American College of Cardiology.
    • The AHA’s “Life’s Essential 8” include:
      • Eating better. Recommendations include whole foods, lots of fruits and vegetables, lean protein, nuts, seeds, and using olive or canola oil for cooking.
      • Staying active.
      • Quitting tobacco and vaping.
      • Getting healthy sleep. For most adults, this is seven to nine hours of sleep each night.
      • Managing weight.
      • Controlling cholesterol. LDL, or “bad” cholesterol, should be 100 milligrams per deciliter or lower, Nissen said.
      • Managing blood sugar. If you have diabetes, pay attention to your hemoglobin A1C levels, which should be below 5.7 percent.
      • Managing blood pressure. For most people, blood pressure should be below 120/80, Nissen said.
  • Medscape adds,
    • “Many people with obesity have chronic pain due to joint stress and inflammation. Speaking to these patients about modifiable lifestyle factors — like diet and exercise — can help improve their pain severity and quality of life.
    • “In a new study published in the European Journal of Nutrition, patients with overweight or obesity who followed a 3-month weight-loss dietary intervention cut chronic musculoskeletal pain scores in half — independent of adiposity changes.”
  • NBC News reports,
    • “Short bursts of purposeful activity — such as walking around the block or lifting small weights — may be the best way to get in the habit of exercising. Bite-sized bits of exercise also improve heart and muscle fitness, a study published Tuesday in BMJ Sports Medicine found.
    • “Less than half of adults in the United States get enough aerobic activity and less than a quarter get the recommended amount of both aerobic and muscle-strengthening exercise. 
    • “When people are asked why they don’t exercise, the answers are almost always the same, no time and no motivation,” Miguel Ángel Rodríguez, a doctoral student in clinical research at the University of Oviedo in Spain, who led the study, said in an email.”
  • Per Health Day,
    • “Memantine improves social impairments in youth with autism spectrum disorder (ASD), according to a study published online Oct. 1 in JAMA Network Open.
    • “Gagan Joshi, M.D., from Massachusetts General Hospital in Boston, and colleagues examined the safety and efficacy of memantine for treating social impairments in youths with ASD in a 12-week placebo-controlled randomized clinical trial. The study population included 42 youths aged 8 to 17 years with ASD without intellectual disability who initiated treatment. The intention-to-treat efficacy analysis included 35 youths (16 treated with memantine and 19 with placebo).”
  • and
    • “More women are choosing to freeze their eggs, but fewer are returning to use them, according to a study published online Aug. 29 in the American Journal of Obstetrics & Gynecology.
    • “Mabel B. Lee, M.D., from the University of California, Los Angeles, and colleagues assessed national trends in planned oocyte cryopreservation, subsequent oocyte utilization, and outcomes of oocyte warming cycles. The analysis included data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (2014 to 2021).”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Medical practice network OneOncology has acquired GenesisCare USA of Florida and is relaunching the practice as SunState Medical Specialists.
    • “The deal adds more than 100 physicians, including urologists, oncologists and surgeons, at 104 clinics throughout Florida to OneOncology’s portfolio, according to a Wednesday news release.
    • “GenesisCare USA of Florida was part of GenesisCare, an Australia-based cancer treatment provider that filed for Chapter 11 bankruptcy protection in 2023. The company, which was backed by private equity firm KKR and China Resources Capital, entered the U.S. in 2020 when it acquired 21st Century Oncology.
    • “As part of bankruptcy proceedings, GenesisCare sought to restructure with about $1.7 billion in debt and separate U.S. operations from those in Australia and Europe. It emerged from the bankruptcy process in 2024 and trimmed its U.S. footprint to Florida and North Carolina markets. 
    • “OneOncology, which is majority owned by TPG Capital, said the latest Florida deal builds on the company’s previous investments in urology. It plans to invest in upgraded technology at SunState Medical and expand access to clinical services such as advanced radiation therapies and interventional radiology, according to the release.”
  • BioPharma Dive tells us,
    • “Having closed a nine-figure fundraising round, a newly launched biotechnology company hopes to rewire the immune system with drugs aimed at a special kind of nerve cell.
    • “Nilo Therapeutics debuted Wednesday, equipped with $101 million from a Series A financing that was co-led by the venture capital firms DCVC Bio, Lux Capital and The Column Group. Alexandria Venture Investments and the Gates Foundation also contributed to the round.
    • “The fresh money, according to Nilo, will go toward growing the biotech’s research and development team, advancing its preclinical drug programs, and establishing laboratories in New York City. Nilo formed through a collaboration between The Column Group and three Ivy League scientists — Charles Zuker, of Columbia University; Ruslan Medzhitov, of Yale University; and Stephen Liberles, of Harvard University.”
  • Per Fierce Healthcare
    • “As pharma giant Eli Lilly builds out its direct-to-consumer care site, LillyDirect, the company has tapped virtual primary care company HealthTap to join its small lineup of independent care providers.
    • “Consumers who come to LillyDirect in search of specific treatments or Lilly-manufactured medications, such as GLP-1s, can find educational materials on common health conditions and access recommendations for in-person or virtual care. 
    • “LillyDirect has been building out its network of independent care providers for a slew of healthcare conditions and specialities, including diabetes, obesity, cancer, dermatology, autoimmune, sleep apnea and migraine.
    • “HealthTap will be listed as a provider for treating type 1 and type 2 diabetes on the LillyDirect site.”
  • and
    • “Allara Health, a virtual women’s health provider, has expanded to all 50 states. 
    • “The provider, specializing in women’s hormonal, metabolic and reproductive health, was in 30 states at the start of the year. Alongside news of the expansion, Allara has also published clinical outcomes data that demonstrate improvements in patient health in a health impact report.
    • “The retrospective analysis included nearly 1,500 patients who either had a PCOS diagnosis or were being seen for other hormonal or metabolic care. It found that in the first nine months of care, patients with a body mass index (BMI) in the obese range (equal to or greater than 30) achieved a 5% mean BMI reduction. A 5% weight reduction is considered clinically significant, the report said.
    • “The analysis also found that after 10 months, two-thirds of prediabetic patients had normalized their A1C levels, and 77% of diabetics reduced their A1C levels out of the diabetic range. Patients with a high level of insulin resistance saw a 12% reduction in those levels.” 
  • and
    • “Amazon Pharmacy is rolling out kiosks stocked with prescription medications to help patients get their meds immediately after appointments. 
    • “The kiosks will launch across One Medical locations in Los Angeles starting December 2025. Expansion to additional One Medical offices is expected soon after. The kiosks will contain commonly prescribed meds like antibiotics, inhalers and blood pressure medications. Controlled substances and medications requiring refrigeration are not available.” 

Tuesday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “The guarantee of back pay for furloughed federal employees is now in limbo, as the White House weighs a different interpretation of the 2019 law that ensures federal employees get compensated following a government shutdown.
    • “A new draft legal opinion from the Office of Management and Budget, as first reported by Axios, argues that whatever funding legislation Congress ultimately passes to end the current shutdown must explicitly include appropriations to provide back pay for furloughed federal employees. And if it’s not expressly written in the spending legislation, the OMB memo argues that furloughed workers cannot receive any retroactive compensation.
    • “A copy of the OMB document, which a senior White House official shared with Federal News Network, appears to contradict OMB’s previous interpretation of the Government Employee Fair Treatment Act, or GEFTA, which President Donald Trump signed into law in 2019 during the last government shutdown. Both OMB and the Office of Personnel Management previously affirmed that under GEFTA, excepted and furloughed employees would be given back pay as soon as possible, once any current or future shutdown ends.”
  • In the FEHBlog’s opinion, this draft OMB opinion is a lead balloon.
  • Healthcare Dive shares six takeaways from CMS Administrator Mehmet Oz’s appearance on Monday before a Washington D.C. think tank audience.
  • Modern Healthcare reports,
    • “Federal regulators say they have made inroads into speeding up the process to resolve out-of-network billing disputes. It’s not enough for frustrated providers and health insurance companies.
    • “The No Surprises Act’s Independent Dispute Resolution, or IDR, process has been a punching bag for both camps since it launched in 2022, and a backlog of cases had piled up by the beginning of this year.
    • “But the share of IDR cases unsettled after 30 business days fell from 69% in January to 34% in July, the most recent month for which data are available, according to the Health and Human Services, Labor and Treasury departments. Likewise, 96.5% of disputes submitted since 2022 are either resolved or are less than 30 business days old, the departments wrote in a notice published Sept. 19.
    • “The departments’ efforts have delivered remarkable improvements in the throughput of cases compared to prior years,” the notice says. “IDR entities are now resolving disputes faster than they are submitted.”
  • STAT News informs us,
    • “The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
    • “Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.”
    • “They have to now,” said one lobbyist of their clients’ thinking, noting the “anger”with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
    • “The people cautioned that negotiations remain unfinished and several variables, including the government shutdown, could delay any announcements.
    • “The growing chatter around potential announcements signals the Trump administration’s pressure campaign may be paying off. But whether the deals will actually accomplish the administration’s objective — lowering prescription drug prices — remains unknown.”
  • Fierce Healthcare points out,
    • “The current state of the Medicare Part D market is a mixed bag, with premiums declining but many payers scaling back options, according to a new analysis from KFF.
    • “The report noted that the Centers for Medicare & Medicaid Services put an emphasis on “stability” in Part D when it announced premium estimates in late September, but KFF found that the total number of stand-alone Part D plans available will decrease in 2026, marking the third straight year of shrinking plan options.
    • “Some payers are trimming down their offerings, per the report. For example, Centene is ending three drug plans offered through WellCare and Health Care Service Corporation is discontinuing one of Cigna’s three Part D plans and pulling back from certain regions.
    • “Other insurers, such as Elevance Health, are exiting the stand-alone Part D plan market entirely.
    • “For 2026, beneficiaries in each state will be able to select from between eight and 12 stand-alone Part D plans, in addition to Medicare Advantage prescription drug coverage. Across the 34 Part D plan markets, a total of 360 plans will be made available by 17 parent organizations—a decrease of 22% from 2025.”
  • “As many major insurers scale back on Medicare Advantage,” Beckers Payer Issues takes a “look at the insurers that are fully backing out.”
  • NextGov/FCW explains how OPM Director Scott Kupor plans “to attract tech talent [to federal government employment] after months of workforce cuts.”
  • Per HR Dive,
    • “The U.S. Senate confirmed Brittany Panuccio, an assistant U.S. attorney for the Justice Department in Florida, as a commissioner for the U.S. Equal Employment Opportunity Commission in a 51-47 vote Tuesday. Panuccio’s confirmation was part of an en bloc vote on several nominations.
    • “Panuccio fills the seat vacated in December by Keith Sonderling, who was named deputy labor secretary in March, and gives Republicans a majority. Her term expires July 1, 2029. 
    • “Panuccio’s confirmation restores a quorum to EEOC, which has operated with only two commissioners since January, when President Donald Trump fired Democratic commissioners Charlotte Burrows and Jocelyn Samuels before the expiration of their terms.”

From the Food and Drug Administration front,

  • Healio adds,
    • “The FDA approved Zoryve cream 0.05% for the treatment of children aged 2 to 5 years with mild to moderate atopic dermatitis, according to a press release. 
    • “Currently, there are approximately 1.8 million children aged 2 to 5 years being treated with a topical therapy for AD. Zoryve (roflumilast, Arcutis) cream 0.05% is a once-daily, next-generation phosphodiesterase-4 inhibitor that offers a nonsteroidal option for children and their caregivers.
    • “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and vice chair of the department of dermatology at University of California San Diego, said in the release. “Young children often experience widespread disease, affecting large portions of their skin. Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reassuringly explains how to get a Covid booster vaccination under the CDC’s newly approved guidelines.
  • MedPage Today reports
    • “To prevent measles outbreaks, public health systems and clinicians should look below the 35,000-foot view of state- and county-level vaccination rates against measles, mumps, and rubella (MMR) and instead aim their focus on at-risk school districts and schools, according to a statewide analysis of Texas counties.”
  • and
    • “The pre-cooked pasta Listeria recall broadened to include pasta salads and prepared dishes at Kroger, Trader Joe’s, and more grocery stores.
    • “Some Hello Fresh meals may contain Listeria-tainted spinach, USDA’s Food Safety and Inspection Service warned.
    • “Chicken corn dog products from Foster Poultry Farms also were recalled after wood was found in the batter causing at least five injuries. (NBC News)”
  • Per Healio,
    • “Changing trajectories of heart health markers during young adulthood were associated with potentially increased risk for cardiovascular disease later in life, researchers reported.
    • “In addition, individuals who maintained higher levels of CV health through young adulthood had lower risk for incident CVD vs. those whose CV health was maintained at lower levels or declined, according to data published in JAMA Network Open.”
  • and
    • “Acupuncture needling greatly improved pain-related disability in older adults with low chronic back pain compared with usual care, a randomized controlled trial demonstrated.
    • “Acupuncture may be an effective and safe pain management tool for many older adult patients,” Lynn L. DeBar, PhD, MPH, a researcher at Kaiser Permanente Center for Health Research, told Healio. “While it is unlikely to take away all the pain, this study suggests that it can decrease pain-related disability substantively.”
  • The New York Times considers that “He was expected to get Alzheimer’s 25 years ago. Why hasn’t he? Scientists are searching for the secret in [76-year-old] Doug Whitney’s biology that has protected him from dementia, hoping it could lead to ways to treat or prevent Alzheimer’s for many other people.”
  • Per Health Day,
    • “Preschoolers who regularly overeat are likely swallowing their emotions as well, a new study says.
    • “Girls who overeat as preschoolers are more likely to develop anxiety, impulsivity and hyperactivity when they grow into teenagers, researchers reported in the journal BMC Pediatrics.
    • “The results indicate that children’s eating patterns could be early signs of mental health challenges, researchers said.
    • “Occasional overeating is normal, but if a child frequently overeats, it can be a sign of emotional struggles,” senior researcher Linda Booij, a professor of psychiatry at McGill University in Quebec, Canada, said in a news release.”
  • Per Genetic Engineering and Biotechnology News,
    • “A research team co-led by scientists at Institute for Bioengineering of Catalonia (IBEC) and West China Hospital Sichuan University (WCHSU), working with partners in the U.K., has developed a nanoparticle technology that studies showed can reverse Alzheimer’s disease (AD) in mice. Unlike other types of nanomedicine that rely on nanoparticles as carriers for therapeutic molecules, this approach employs nanoparticles that are bioactive in their own right, and which the team refers to as “supramolecular drugs.”
    • “Instead of targeting neurons directly, the therapy restores proper function of the blood-brain barrier (BBB), the vascular gatekeeper that regulates the brain’s environment. The BBB is a cellular and physiological barrier that separates the brain from the blood flow to protect it from external dangers such as pathogens or toxins. Through their newly reported research the investigators demonstrated that targeting a specific mechanism enables undesirable “waste proteins” produced in the brain to pass through this barrier and be eliminated in the circulation. In Alzheimer’s disease, the main waste protein is amyloid-β (Aβ), the accumulation of which impairs normal neuronal function.
    • “By repairing this critical interface, the researchers observed a significant reduction in brain amyloid-β (Aβ) levels and a reversal of Alzheimer’s pathology in the animal models, with cognitive benefits lasting up to six months following treatment.
    • “Study lead Giuseppe Battaglia, PhD, ICREA research professor at IBEC, principal investigator of the Molecular Bionics Group, and colleagues reported on their findings in Signal Transduction and Targeted Therapy, in a paper titled “Rapid amyloid-β clearance and cognitive recovery through multivalent modulation of blood–brain barrier transport,” in which they stated, “This innovative therapeutic paradigm offers a promising pathway for developing effective clinical interventions, addressing vascular contributions to AD, and ultimately enhancing patient outcomes…The therapeutic trilogy achieved—amyloid clearance, barrier restoration, and sustained cognitive recovery—establishes a blueprint for precision neurovascular medicine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “It was a repeat performance for all 10 children’s hospitals named as the nation’s best in this year’s iteration of U.S. News & World Report’s ranking.
    • “The highly watched list, now in its 19th year, reviewed outcomes, practices and surveyed opinions for 198 children’s hospitals.
    • “Of these, 86 hospitals were named in some respect, whether that be a top-10 ranking for 10 different pediatric specialties and/or as one of 50 unranked facilities named as a high performer on pediatric and adolescent behavioral health.
    • “Among these, 10 children’s hospitals were named to the list’s honor roll for scoring well across multiple specialties. That unranked collection is identical to last year’s honorees.
      • “Boston Children’s Hospital
      • “Children’s Hospital Colorado, Aurora
      • “Children’s Hospital Los Angeles
      • “Children’s Hospital of Philadelphia
      • “Children’s National Hospital, Washington, D.C.
      • “Cincinnati Children’s
      • “Nationwide Children’s Hospital, Columbus, Ohio
      • “Rady Children’s Hospital, San Diego
      • “Seattle Children’s Hospital
      • “Texas Children’s Hospital, Houston”
  • and
    • “Providers are betting on artificial intelligence to ease the pain point of prior authorization, a new survey shows.
    • “Cohere Health, which provides clinical intelligence to insurers and risk-bearing providers, polled 200 clinicians and office administrators and found that 99% of clinicians report confidence in using AI to back prior authorization. Most (96%) office administrators said the same.
    • “Two-thirds of those surveyed said a completely digital prior authorization process would significantly improve their workflows. Across the board, the respondents said the process should have real-time tracking baked into the experience, allowing them to track the status of key requests.
    • “Providers are speaking loud and clear: they want and deserve a prior authorization process that is smarter, simpler and more transparent,” said Brian Covino, M.D., chief medical officer of Cohere Health, in an announcement.”
  • Healthcare Dive relates,
    • “Saint Peter’s Healthcare System and Atlantic Health abandoned plans to merge on Monday, citing impacts of the “rapidly evolving healthcare landscape nationally.”
    • “The New Jersey-based health systems first announced plans to combine in January last year and signed a definitive agreement to merge in June 2024. 
    • “The systems shared scant details about why the deal fell apart. However, in a joint statement issued Monday both Atlantic President and CEO Saad Ehtisham and Saint Peter’s President and CEO Leslie Hirsch called the deal’s end disappointing.”
  • STAT News informs us,
    • “Just a decade ago, a doctor with multiple medical licenses was an anomaly. Sometimes physicians would apply for credentials from a few states if they lived near a border and wanted the flexibility to practice on either side, since a doctor needs to be licensed where their patient is physically located. In-demand specialists might get a few more if they wanted to see patients virtually. But in the years since Covid began driving patients online, the number of physicians seeking multi-state licensure has ballooned to support the growing field of telehealth.
    • “Within that group, a STAT analysis of physician licenses shows that a small but powerful cohort of physicians is accumulating licenses in all 50 states, plus the nation’s capital and its territories. These physicians don’t max out on licenses just to practice across state lines. Often, they own the medical groups that are affiliated with nationwide telehealth companies. A doctor’s full roster of medical licenses can be leveraged for online businesses that provide specialty care, build patient funnels for pharma companies seeking to sell drugs directly to consumers, prescribe compounded meds — or sometimes, all of the above. 
    • “In 2016, just nine physicians in the U.S. held active licenses in all 50 states, according to data from the Federation of State Medical Boards. By 2024, 172 doctors had filled out their bingo card, and another 356 doctors had acquired at least 45 licenses — significantly outpacing the profession’s overall growth.”
  • As we approach Open Season, the American Diabetes Association offers “Health Insurance Aid for Diabetes. Access to medical care is key to managing your diabetes. Get more information on resources available to people living with diabetes.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The partial government shutdown rolled on Thursday with both sides dug in and President Donald Trump using the funding lapse as an excuse to cut billions of dollars in “dead wood,” as he put it, throughout the executive branch.
    • “Trump said in a social media post that he’d meet with Office of Management and Budget Director Russ Vought to go over “which of the many Democrat Agencies” should be cut as the GOP seeks to make the shutdown more painful for Democratic leaders.
    • “Neither chamber had votes on Thursday as lawmakers observed the Yom Kippur holiday, with the House not returning until Tuesday. The Senate will get another opportunity to vote Friday at 1:30 p.m., but there were no signs of a bipartisan breakthrough yet.
  • Beckers Hospital Review tells us what the Centers for Medicare and Medicaid Services (“CMS”) said will and won’t continue during a lapse in appropriations. Here’s what will continue:
    • “CMS said it will have sufficient funding for Medicaid to fund the first quarter of fiscal 2026, which runs through Dec. 31. 
    • “The agency will maintain the staff necessary to make payments to eligible states for the Children’s Health Insurance Program.
    • “Federal marketplace activities will continue, including eligibility verification.
    • “Other non-discretionary activities, including Health Care Fraud and Abuse Control and the Center Medicare & Medicaid Innovation will also continue. 
  • You can look at the article to find out what’s not continuing.
  • Avalere Health points out that “Part D Choices Continue to Shrink with Fewer PDPs in 2026.”
    • “The Part D market will contract even further in 2026, with a 22% decrease in standalone PDP options and a 9% decrease in non-SNP MA-PDs.”
    • SNP MA-PDs are a type of Medicare Advantage plan for people who are eligible for both Medicare and Medicaid.
  • The American Medical Association News relates,
    • “The Centers for Medicare & Medicaid Services Sept. 30 issued a memo, through the Health Plan Management system, finalizing the Medicare Advantage Utilization Management Annual Data Submission requirements for MA organizations. CMS has limited the scope of the annual data collection to internal coverage criteria for MA services — including Medicare Part B drugs — that require prior authorization. Criteria used exclusively for other review types, such as concurrent or payment reviews, will not be collected. CMS decided not to finalize the proposed audit protocol and corresponding audit tools, citing concerns about duplicative audits, but may consider incorporating review of internal coverage criteria into future program audits.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • The FDA approved a new generic version of the abortion pill mifepristone, a 200-milligram oral tablet, from Evita Solutions.
    • The FDA’s approval of the generic mifepristone comes as the Department of Health and Human Services reviews the drug’s safety.
    • Antiabortion lawmakers and groups criticized the approval, while abortion-rights groups emphasized the drug’s safety and effectiveness.
  • BioPharma Dive adds,
    • “The Food and Drug Administration, already reeling from layoffs and leadership changes under the Trump Administration, warned that the government shutdown will delay or pause important work at the agency.
    • “In a memo released before the shutdown began, the FDA said it expects to retain 86% of its staff, or 13,872 employees. The agency can continue reviewing existing applications for products, including drugs and medical devices that are funded by user fees, but will not be able to accept new submissions. 
    • “The FDA will also stop many regulatory activities that don’t address “imminent threats to the safety of human life.” For instance, food safety efforts will be reduced during the shutdown, and the agency won’t be able to support much of the work done to protect Americans from unsafe and ineffective compounded drugs, the FDA said.”
  • MedTech Dive notes,
    • “The Food and Drug Administration has released a list of the medical device guidance documents that it plans to develop or publish in its 2026 financial year.
    • “The agency said Tuesday that its top priorities include the finalization of guidance on the use of real-world evidence to support regulatory decisions and on predetermined change control plans for medical devices. 
    • “Three of the FDA’s four priority draft guidance documents are holdovers from the 2025 list. Like last year, the FDA has listed guidance on air purifying respirators and menstrual products among its top draft document priorities for 2026.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “In its latest weekly update [Wednesday], the US Centers for Disease Control and Prevention (CDC) reported 30 more measles cases, putting the national total at 1,544, a record high since the United States eliminated the disease in 2000.
    • “Two more outbreaks were reported, bringing the total to 42. The CDC said 86% of cases are linked to outbreaks, and 92% of patients are unvaccinated or have an unknown vaccination status. The number of affected jurisdictions remained the same, at 42. 
    • “So far, 21 cases have been reported in international visitors.”
  • The American Medical Association lets us know what doctors wish patients knew about vitamins and supplements.
  • Beckers Hospital Review notes,
    • “Nursing homes in Vermont and Wyoming had the highest percentage of residents experiencing one or more falls with major injury between April 1, 2024, and March 31, 2025, according to CMS data published Sept. 24. 
    • “The District of Columbia and California had the lowest percentage for the same time period. 
    • “A recent HHS report found that nursing homes fail to report 43% of falls that resulted in major injury and hospitalization among Medicare-enrolled residents.
    • “The national percentage of nursing home residents experiencing one or more falls with major injury was 3.28%.” 
  • CNN relates,
    • “A new report ranks US states on rates of mental well-being and mental health care, and New York, Hawaii and New Jersey have outperformed the rest — in that order.
    • “The 2025 State of Mental Health in America report sizes up how all 50 states and Washington, DC, fared on 17 measures of mental health in 2022 and 2023, according to Mental Health America, which published the report on Wednesday. The nonprofit promotes mental health and illness prevention through education, research and advocacy.
    • “The 17 factors mainly concern adults and youth who experienced mental illness, suicidal thoughts or substance use disorder in the past year; adults and youth who didn’t receive necessary treatment, couldn’t afford it or were uninsured; people with insurance that didn’t cover mental or emotional problems; and the availability of mental health providers.
    • “Nevada had the worst rating, followed by Arizona and Alabama — marking the second time Nevada and Arizona have ranked the lowest, “underscoring a high need for strategic investment in mental health in these states,” MHA said in a news release.”
  • NBC News reports
    • “People who learn they have autism after age 6 — the current median age at diagnosis — are often described as having a “milder” form of autism than people diagnosed as toddlers.
    • “A new study challenges that assumption.
    • “A genetic analysis finds that people with autism spectrum disorder diagnosed in late childhood or adolescence actually have “a different form of autism,” not a less severe one, said Varun Warrier, senior author of a study published Wednesday in Nature.
    • “The “genetic profile” of people with late-diagnosis autism actually looks more like depression, attention-deficit/hyperactivity disorder and post-traumatic stress disorder than early childhood autism, said Warrier, an autism researcher at the University of Cambridge. 
    • “The study illustrates that autism is not a single condition with one root cause, but rather an umbrella term for a cluster of conditions with similar — although not identical — features, said Geraldine Dawson, founding director of the Duke Center for Autism and Brain Development, who wasn’t involved in the new report.”
  • STAT News adds,
    • “Researchers have found that patients with amyotrophic lateral sclerosis have autoimmune responses, a finding with the potential to reshape how scientists think of the devastating and complex neurologic disorder.
    • “A team led by scientists at La Jolla Institute for Immunology analyzed blood samples from 40 ALS patients and 28 people without the disease. They found that those with ALS had on average stronger immune cell responses than healthy controls to C9orf72, a protein active in neurons and associated with the rare condition. Other proteins linked to ALS, however, were not preferentially targeted by patients’ immune systems.
    • “The authors discovered that, among patients with responses against C9orf72, those with immune cells that produced signals known to tamp down inflammation were predicted to have longer survival times than ALS patients with more inflammatory responses.
    • “The findings, published in the journal Nature on Wednesday, suggest to Samuel Pfaff, an ALS researcher at the Salk Institute, that there is an autoimmune component to the disease. That’s something previous studies have suggested but have not conclusively shown. The results raise the possibility that researchers could one day treat ALS patients in new ways by targeting their immune system, and that scientists might monitor disease progression by tracking autoimmune cells.
    • “I think it’s giving us a greater appreciation of a variety of aspects of the disease,” said Pfaff, who was not involved in the study. “It is providing some new thinking about how to consider treating the disease.”
  • and
    • “Researchers have shut pregnant women out of gold-standard clinical trials in order to protect them and their babies. But the practice has had the opposite effect.
    • “Instead, women have to wade through a chaotic data landscape, and many may choose to suffer through untreated illnesses. 
    • “Besides sowing confusion, the lack of data makes it easier for people to obfuscate and misconstrue existing data. That dynamic was on full display last week as President Trump and Health and Human Services Secretary Robert F. Kennedy Jr. urged pregnant women to avoid Tylenol as they claimed, without clear evidence, that the active ingredient acetaminophen causes autism. 
    • “The existence of this data gap is well established. But it’s gained new relevance as federal officials zero in on the medical decisions of pregnant women, searching for evidence of harm to fetuses.” 
  • Per Health Day,
    • “The early warning signs of multiple sclerosis appear to be the same for everyone, regardless of their background.
    • “The pain, mood changes, brain decline and neurological problems associated with early MS can appear years before diagnosis but appear to affect all types of people in similar ways, according to a new study.
    • “Our study shows that the very earliest features of MS are similar regardless of someone’s ethnic or socio-economic background,” said researcher Ben Jacobs, a clinical lecturer in neurology at Queen Mary University of London.
    • “Efforts to detect MS earlier or identify people at high risk should therefore be inclusive and representative of the whole population,” Jacobs said in a news release.” * * *
    • “The new study appeared Sept. 24 in the Annals of Clinical and Translational Neurology.”
  • Per BioPharma Dive,
    • “Amgen’s cholesterol-lowering shot Repatha met its main goals in a large trial evaluating use as a “primary prevention” therapy, besting a placebo at reducing the risk of cardiovascular events or death in people who’d never had a heart attack or stroke, the company said Thursday.
    • “Repatha, a so-called PCSK9 inhibitor, is currently available as a “secondary prevention” therapy for those with a history of heart disease and at high risk of experiencing another. Though it’s sometimes also used “off-label” in the much larger primary prevention setting, an approval backed by the latest study results — which Amgen referred to as a “landmark” finding — could substantially widen use. 
    • “Once forecast to achieve tens of billions of dollars in annual sales, Repatha has fallen short of those lofty projections amid pushback from insurers and a modest benefit in those with established heart disease. Still, sales surpassed the $1 billion mark in 2021 and have grown since. The Food and Drug Administration also recently expanded use in those at higher risk of major cardiovascular events.”
  • The New York Times reports,
    • “Jane Goodall, who died on Wednesday at the age of 91, followed several principles that geriatricians recommend for a long and healthy life.
    • “A scientist, conservationist and author, Dr. Goodall stayed active, working until the day she died. She had a clear sense of purpose for her life. And she was an enduring optimist.
    • “Over a nearly seven-decade career, Dr. Goodall taught us about the intelligence of chimpanzees. But she left behind powerful teachings about aging — and living well — too.”
      • “Her work kept her active.”
      • “She had a ‘reason for being.’”
      • “She maintained a positive outlook on life.”

From the U.S. healthcare business front,

  • Beckers Payer Issues lets us know,
    • “Despite Cigna launching its downcoding policy on Oct. 1, the insurer is temporarily holding off on implementing it for California HMO plans, according to the California Medical Association and Cigna.
    • “The policy allows Cigna to adjust some higher-level evaluation and management codes if they do not meet certain complexity standards. Codes 99204-99205, 99214-99215 and 99244-99245 fall under this policy. After receiving questions over its legality, the reimbursement policy is awaiting review by the California Department of Managed Health Care.
    • “This approach also introduces avoidable friction with physician practices into the process, erodes trust between providers and plans, and exacerbates the challenges of delivering high-quality care in a resource-constrained environment,” the California Medical Association wrote in a letter to Cigna.
    • “Our new policy that ensures the limited number of impacted physicians are reimbursed appropriately for E/M services took effect as planned, with the exception of California HMO plans regulated by the state Department of Managed Health Care,” a Cigna spokesperson told Becker’s. “We anticipate that the policy will also take effect for these plans’ claims in California after the DMHC completes its review of the additional information that we have provided.”
  • Beckers ASC Review adds,
    • “On Oct. 1, a new UnitedHealthcare policy went into effect, cutting reimbursements to certified registered nurse anesthetists by 15%. 
    • “The policy update was issued on July 1 and applies to claims for anesthesia services rendered by CRNAs practicing independently. For claims billed under the QZ modifier — those rendered by CRNAs — the provider will now receive 85% of the allowable. 
    • “CRNAs in Arkansas, California, Ohio, Colorado, Hawaii, Massachusetts, New Hampshire and Wyoming are exempt from the new reduction. 
    • “The update has drawn criticism from the American Association of Nurse Anesthesiology, who told Becker’s in an Oct. 1 email that the policy “threatens patient care” and could lead to delayed procedures and strained access to care, particularly in rural and underserved communities where CRNAs are more heavily utilized for anesthesia services. 
    • ‘The AANA also claims the policy is in violation of a provider nondiscrimination provision outlined in the ACA. The organization has also written a coalition letter urging the secretaries at the Department of Labor, HHS and Department of Treasury to investigate and prohibit commercial payers from violating this nondiscrimination provision.”
  • The Healthcare Cost Institute tells us what preventive care costs.
  • STAT News reports,
    • “UnitedHealth Group has tapped a Duke University artificial intelligence expert to be its chief AI scientist as the health care giant ramps up the use of the technology across its sprawling network of businesses, according to a memo obtained by STAT.
    • “Michael Pencina, chief data scientist for Duke Health, stepped down from his role at Duke on Wednesday to take the job at UnitedHealth, according to the memo from Mary Klotman, dean of the Duke University School of Medicine.”
  • Per Modern Healthcare,
    • “Providence finalized Wednesday the second phase of a joint venture with Compassus to manage the health system’s home care operations in California.
    • “Under the terms of the deal, Compassus will manage approximately 20 home health, hospice, personal home care and palliative care locations under the name Providence at Home with Compassus.
    • “The deal is part of a broader initiative Renton, Washington-based Providence inked with Compassus last year to operate home care locations across Alaska, Texas, Washington, California and Oregon. Compassus began managing 14 locations in Alaska, Texas and Washington in March.”
  • Per Fierce Healthcare,
    • “NeueHealth officially ceased trading on the New York Stock Exchange after completing its go-private deal with an affiliate of New Enterprise Associates.
    • “The company, once known as Bright Health Group, was scooped up on Thursday by the NEA unit with an enterprise value of about $1.5 billion, following a series of financial struggles. Common stockholders in NeueHealth will receive $7.33 per share as part of the sale, according to an announcement.
    • “Certain shareholders in the company—including New Enterprise Associates and 12 other investors who hold all of its preferred stock—will instead enter into a rollover agreement, where they will exchange shares for equity interest in the now-private enterprise.
    • “In addition, NeueHealth’s leadership will continue in their roles and have similarly rolled their holdings into equity in the private company.”
  • and
    • “Startup SpotitEarly is pioneering an innovative early cancer screening test based on breath samples and powered by artificial intelligence and the strong scent detection of trained dogs.
    • “SpotitEarly launched in the U.S. market in May, armed with $20 million in funding. The company, initially founded in Israel, plans to roll out its breath-based, at-home early detection test in the U.S. next year. It’s preparing for an FDA pre-submission as part of a phased regulatory strategy, executives said.
    • “New Jersey-based Hackensack Meridian Health is teaming up with the startup to validate its non-invasive approach to early cancer detection.
    • “As part of the research collaboration, SpotitEarly will work with the Hennessy Institute for Cancer Prevention and Applied Molecular Medicine, part of the Hackensack Meridian John Theurer Cancer Center, and Hackensack University Medical Center.”
  • Beckers Hospital Review relates,
    • “Eight states tied for having the lowest rates of patients who left hospital emergency departments without being seen, at 1%, CMS data showed.
    • “CMS’ Timely and Effective Care dataset, updated Aug. 6, tracks the percentage of patients who left an ED before being seen between January and December 2023. The measures apply to children and adults treated at hospitals paid under the inpatient or the outpatient prospective payment systems, as well as hospitals that voluntarily report data on relevant measures for Medicare, Medicare-managed care and non-Medicare patients. Averages include data for Department of Veterans Affairs and Defense Department hospitals. Read the methodology here. 
    • “The national average showed 2% of patients left EDs before being seen in 2023. This is returning to prepandemic levels, after the rate went up to 3% in 2022.”

Midweek report

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

From Washington, DC,

  • Roll Call reports,
    • “Amid tough talk from both sides of the aisle about who’s to blame for the partial government shutdown, bipartisan talks began to take shape as the rank-and-file sought a way out of the impasse.
    • “Various groups of senators were seen huddling on the floor Wednesday during a vote series, even as Democrats again mostly rejected the House-passed stopgap funding bill that would reopen the government through Nov. 21.
    • “The 55-45 margin on the procedural vote was the same tally as the night before, with the same three Democratic caucus members crossing the aisle to support it: Nevada’s Catherine Cortez Masto, Pennsylvania’s John Fetterman and Maine’s Angus King, an independent who caucuses with the party.
    • “That’s two more Democratic caucus members than voted for the measure 10 days ago, which Republicans believe demonstrates fissures in the ranks that will only grow as the shutdown’s impacts build. But it’s five votes short of the 60 needed to overcome a filibuster.”
  • The Wall Street Journal adds,
    • “During a huddle with a bipartisan group of senators on the floor Wednesday, Sen. Ruben Gallego (D., Ariz.) floated the idea of voting to reopen the government with a commitment from Republicans to negotiate on the healthcare subsidies by Nov. 1. Republicans reiterated they didn’t want to negotiate while the government was shut down, according to a person familiar with the conversation.
    • “This is us, just senators randomly getting together and spit balling, and then see if we can get to some kind of consensus,” Gallego said. “And then I think a lot of us would then go back to our leadership and then go from there.”
  • Federal News Network informs us,
    • “After congressional appropriations lapsed and a government shutdown began at midnight on Oct. 1, the Trump administration now warns that further federal employee layoffs are imminent.
    • “It’s unclear which agencies will move forward with potential layoffs, beyond at least one agency — the U.S. Patent and Trademark Office — that on Wednesday issued layoff notices. Vice President JD Vance doubled down on the Office of Management and Budget’s last week’s directive to terminate more federal employees in the case of a government shutdown.
    • “If this thing drags on for another few days, or, God forbid, another few weeks, we are going to have to lay people off,” Vance told reporters during a White House press conference Wednesday afternoon. “We’re going to have to save money in some places so that essential services don’t get turned off in other places.”
    • “OMB Director Russell Vought took a more immediate stance on how quickly he expected RIFs to take place. In a private call with House Republicans on Wednesday, Vought said agency RIFs would begin “in a day or two,” according to reporting from Politico.”
  • Fierce Healthcare offers a look at the major insurers’ 2026 Medicare Advantage plans and adds,
    • “On day one of the government shutdown, the Centers for Medicare and Medicaid Services (CMS) sent out a Medicare Learning Network Connects Newsletter offering guidance on Medicare billing and telehealth services during the lapse in appropriations. 
    • “CMS reaffirmed in the guidance that pandemic-era expanded telehealth flexibilities have ended for Medicare beneficiaries. Per standard course of action, CMS has directed Medicare Administrative Contractors (MACs) to implement temporary claims hold for 10 business days on telehealth claims. 
    • “Assuming the hold starts Oct. 1, claims will begin to be processed on Oct. 15. The guidance says that providers can still submit claims during the temporary hold, but they will not receive payment. 
    • “The claims hold is meant to avoid the reprocessing of claims in the event that Congress re-ups the flexibilities.” 
  • The White House posted a fact sheet about “the first agreement with a major pharmaceutical company, Pfizer, to bring American drug prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).”
  • The Wall Street Journal explains “How Trump’s Drug-Buying Site ‘TrumpRx’ Will Work. If you are among the 90% of Americans who have health insurance, it’s unlikely to save you much money.”
    • “President Trump announced a deal with Pfizer to sell drugs at reduced prices via TrumpRx.gov and to Medicaid at Most Favored Nation prices.
    • “TrumpRx.gov, launching in early 2026, will offer Pfizer drugs, including Eucrisa and Xeljanz, with average savings of 50%.
    • “The initiative primarily benefits the 27 million uninsured Americans, as 90% with insurance likely save more using their plans.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Children and teenagers are twice as likely to develop long Covid after a second coronavirus infection as after an initial infection, a large new study has found.
    • “The study, of nearly a half-million people under 21, published Tuesday in Lancet Infectious Diseases, provides evidence that Covid reinfections can increase the risk of long-term health consequences and contradicts the idea that being infected a second time might lead to a milder outcome, medical experts said.
    • “Dr. Laura Malone, director of the Pediatric Post-Covid-19 Rehabilitation Clinic at Kennedy Krieger Institute in Baltimore, who was not involved in the study, said the findings echo the experience of patients in her clinic.
    • “Just because you got through your first infection and didn’t develop long Covid, it’s not that you are completely out of the woods,” she said.”
  • STAT News tells us “Leucovorin has a place in autism treatment, researcher says, but he tamps down parents’ expectations. ‘I haven’t seen a remarkable response,’ says Robert Hendron, who studied its use in kids with ASD.”
  • The Washington Post calls attention to “what you should know before buying folate and folinic acid supplements. Medical experts warn against treating over-the-counter supplements the same as leucovorin, the drug the Trump administration has touted as an autism treatment.”
  • Cigna, writing in LinkedIn, discusses the unique health needs of women.
  • Medscape lets us know that “A prospective cohort study found that a high intake of ultraprocessed foods (UPFs) was associated with an increased risk for overall colorectal cancer (CRC) and right-sided colon cancer.”
  • The Washington Post relates,
    • “Walmart will stop using synthetic dyes and certain preservatives, artificial sweeteners and fat substitutes in its private-label offerings, adding the world’s largest retailer to the growing contingent of brands moving to banish food additives amid questions about their health risks.
    • “The announcement Wednesday comes as consumers are pressing for healthier options, and as state and federal officials crack down on the use of petroleum-based dyes in cereals, condiments and a variety of other foods. Health and Human Services Secretary Robert F. Kennedy Jr. — who has likened such additives to “poisonous compounds” — said in April that the administration had reached an “understanding” with the food industry to phase out several colorings over the next few years. General Mills, Kraft Heinz and other foodmakers have since issued statements to that effect.”
    • “Walmart said it will excise nearly 30 additives from its private-label food portfolio by January 2027, including its Great Value, Freshness Guaranteed, Bettergoods and Marketside brands.”
  • Medscape points out what scientists are learning about laser tattoo removal.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit is betting on ambulatory care expansion to shore up operations and putting hospital deals on ice.
    • “The Chicago-based system has added 90 ambulatory care sites to its footprint in its last two fiscal years, 34 of which opened across nine states in fiscal 2025, which ended June 30.
    • “At this point, we’re not focused on hospital acquisitions. We’re primarily looking at ambulatory growth to meet the needs of our consumers,” said CommonSpirit CEO Wright Lassiter III on a Wednesday earnings call. “We are very intentional about where we’re headed and what we believe we need to do to create the kind of success we want as a ministry.”
  • and
    • “Health insurance companies and health systems are familiar with heated contract battles, but the scramble to lock down favorable terms is rising.
    • “Hospitals, under pressure to operate within tight margins, are wrestling with the financial ramifications of looming federal healthcare cuts and coping with sustained labor shortages Insurers seek to clamp down on rising utilization and appease dissatisfied investors.
    • “Those dynamics have fostered an environment that’s led to more messy public contract fights than usual. “We’ve just never seen anything like it,” said Brandon Edwards, CEO of Unlock Health, a marketing agency for providers.
    • “There were 79 confirmed contract disputes between insurers and providers this year as of Sept. 1, according to an FTI Consulting analysis of publicly reported negotiations. Half related to Medicare Advantage, and 20% were unresolved at the beginning of September. The trend has been rising since last year, the analysis shows.”
  • Per Fierce Healthcare,
    • “General Catalyst’s Health Assurance Transformation Company (HATCo) has wrapped its acquisition of Summa Health, shifting the Akron, Ohio-based healthcare system from a nonprofit to a taxed subsidiary.
    • “The deal was first announced in early 2024 and underwent a lengthy regulatory review amid pushback from local residents. Ohio Attorney General Dave Yost gave the transaction a green light during the summer with certain conditions, including an increase in the sale price from $485 million to $500 million.
    • “Today is the culmination of months of collaboration between our organizations and marks the start of a new chapter for Summa Health and those we serve,” Cliff Deveny, M.D., Summa Health President and CEO, said in Wednesday morning’s announcement. “With HATCo, we can preserve our community roots, invest in our team and take bold steps to modernize and expand access to ensure Summa remains strong for decades to come.”
    • “Summa Health is among Ohio’s larger health systems. It employs more than 8,500 people across two acute care hospital campuses, 15 community medical centers, a rehab hospital, a health insurance arm, a multispecialty group practice and a research and medical education program. It reported about $2 billion in total revenue, but a narrow operating loss of $8 million in fiscal year 2024.”
  • and
    • “With $10 billion earmarked to grow its U.S. operations through 2035, AbbVie continues to lay out the particulars on its decade-long domestic investment strategy.
    • “The Chicago-area Big Pharma has kicked off work on a $70 million expansion of its bioresearch center in Worcester, Massachusetts, where the company conducts both manufacturing and R&D for biologic medicines.
    • “The project, which falls under the banner of AbbVie’s broader U.S. investment announced in April, will beef up capacity at the Worcester site that AbbVie plans to use for local production of current and upcoming drugs in cancer and immunology, according to a Sept. 30 press release.
    • “AbbVie is specifically building out additional biologics manufacturing areas at the site, as well as a new three-story building that will contain a laboratory, warehouse and office space. The company said it expects the project to hasten the production transfer of certain oncology meds from Europe to the U.S.”
  • The Wall Street Journal notes,
    • “Patients are increasingly managing their own healthcare due to doctor shortages and chronic diseases.
    • “Direct-to-consumer lab tests are expanding, with Quest Diagnostics, for instance, offering more than 150 tests.
    • “AI chatbots and wearable devices are emerging tools, but concerns exist regarding data privacy, misinformation and clinical validation.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The federal government was on course to shut down early Wednesday, as hopes of any last-minute deal evaporated and both Republicans and Democrats appeared content to trigger the first lapse in funding since President Trump’s first term.”
  • The Senate voted 55-45 on accepting the House Continuing Resolution this evening. A 60 vote in favor was required due to cloture rules. Three Democrats voted in favor and Sen. Rand Paul voted against due to his disdain for continuing resolutions. Roll discusses the vote and next steps in Congress.
  • Govexec adds,
    • “The Trump administration is planning to furlough around 550,000 federal employees on Wednesday if Congress fails to act before government funding expires late Tuesday evening, representing an unusually low less than one-quarter of the workforce. 
    • “The White House is also vowing to oversee large-scale layoffs if a government shutdown occurs, though that would play out through a separate process than the one that sends home certain employees only until funding is restored. In the last 15 years, administrations have typically prepared to furlough between 35% and 40% of the federal workforce.”
  • Federal News Network shares agency shutdown contingency plans.
  • OPM Director Scott Kupor writes in his blog about how he spent days leading to the end of federal fiscal year.
  • The NBC station in Washington, DC, reminds us,
    • “Tens of thousands of government workers are preparing to leave the federal workforce Tuesday, the final day for many who took the government’s “Fork in the Road” resignation offer earlier this year.
    • “Among those are as many as 60,000 retirees who will now anxiously wait for their federal retirement benefits to kick in – a process that could take months and is potentially impacted by the looming government shutdown.
    • “There’s no question there’s going to be a surge. We’re doing everything we can to try and address it,” Office of Personnel Management (OPM) Director Scott Kupor told the News4 I-Team. * * *
    • “Even though OPM knew months ago thousands of employees were leaving, he said their retirements can’t start processing until after they’re off the federal payroll. That’s because each department in the federal government has to wait for an employee’s final paycheck before finalizing their application and sending it to OPM.
    • “Now look, it sounds crazy to me, as well,” he told the I-Team. “And so, one of the things we’re looking at is we’re trying to just basically redesign the entire process from start to finish.”
  • The Wall Street Journal lets us know,
    • “President Trump unveiled plans Tuesday to launch a government-run website, dubbed TrumpRx, for consumers to buy drugs directly from manufacturers, and he said Pfizer plans to offer some of its drugs on the site at a reduced rate.
    • “Separately, Trump said Pfizer would offer all of its drugs to Medicaid at a reduced, “most favored nation” price, as well as introduce any new drugs to the U.S. market at the reduced prices. In return, the company gains a three-year grace period to exempt it from national-security-related tariffs, as long as the company invests in domestic manufacturing, the company said.
    • “The American consumers have been subsidizing research-and-development costs for the entire planet,” Trump said in the Oval Office, flanked by top health officials and Pfizer Chief Executive Albert Bourla.” * * *
    • “Pfizer also announced a $70 billion investment on research and development and manufacturing medications in the U.S.”
  • Per a Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) released final guidance for the third cycle of negotiations under the Medicare Drug Price Negotiation Program (Negotiation Program). This final guidance incorporates significant policy refinements based on public feedback, with a particular focus on increasing transparency, and implements expanded protections for orphan drugs enacted in the Working Families Tax Cuts Act (Public Law 119-21).” * * *
    • “[The] final guidance addresses how drugs payable under Medicare Part B will be eligible for negotiation, requirements and process for renegotiation.”
    • “The Fact Sheet for the Final Guidance for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028 is available at: https://www.cms.gov/files/document/ipay-2028-final-guidance-fact-sheet.pdf.
    • “Additional information about the Medicare Drug Price Negotiation Program can be found at: https://www.cms.gov/priorities/medicare-prescription-drug-affordability/overview/medicare-drug-price-negotiation-program.” 
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services’ (HHS) Administration for Community Living (ACL) today announced $60 million in new grant awards to states, territories, tribes, and local organizations supporting older adults and Americans with disabilities. These awards will strengthen existing programs that protect health, preserve independence, and support caregivers — key priorities of the Make America Healthy Again agenda.”
  • Per a National Institutes of Health news releases,
    • Anthony Letai, MD, Ph.D., was sworn in [yesterday September 29, 2025] as director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), by Health and Human Services Secretary Robert F. Kennedy, Jr.
    • Dr. Letai takes the helm of the world’s most prestigious cancer research agency after serving as professor of medicine at Harvard Medical School and medical oncologist at the Dana-Farber Cancer Institute. He possesses decades of experience studying cell death in cancer, developing treatments, and identifying predictive biomarkers.
  • and
    • “The U.S. Department of Health and Human Services today announced a doubling of funding for its Childhood Cancer Data Initiative (CCDI) at the National Institutes of Health (NIH). The funding surge is designed to accelerate the development of improved diagnostics, treatments, and prevention strategies.
    • “President Trump in 2019 established the CCDI to collect, generate, and analyze childhood cancer data. Its budget will rise from $50 million to $100 million, giving the federal government stronger data for this effort. The initiative will also bring in private-sector partners to apply advanced artificial intelligence to speed up cures for pediatric cancer.
    • “Health and Human Services Secretary Robert F. Kennedy, Jr., NIH Director Jay Bhattacharya, and National Cancer Institute (NCI) Director Anthony Letai joined President Trump at the White House today to discuss their commitment to eradicating childhood cancer and to mark the signing of the president’s executive order, Unlocking Cures for Pediatric Cancer with Artificial Intelligence.“

From the Food and Drug Administration front,

  • FDA Director Marty Makary, MD, announced today,
    • “As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative to increase voluntary compliance from retailers—including vape shops, convenience stores and gas stations—that play a key role in the distribution of both legal and illegal products into American communities.” * * *
    • “We have received questions from retailers about which tobacco products are legal to sell, so we’re mailing materials to more than 300,000 retailers nationwide containing: 
      • “A list of the 39 vapes and 20 nicotine pouch products that can be legally marketed in the United States, which features QR codes linked to the FDA real-time digital versions of these lists (www.fda.gov/authorizedecigs and www.fda.gov/authorizednicotinepouches); 
      • “Information on accessing FDA’s new Searchable Tobacco Product Database, a database of over 17,000 tobacco products—covering all categories, such as cigarettes, cigars, hookah, and e-cigarettes—that may be legally marketed in the United States; and  
      • “New tobacco retailer education materials, including a wall calendar of reminders focused on retailer requirements such as only selling tobacco products to those 21 and older and requiring a photo ID check of anyone under 30.” * * *
    • “Mailings will begin this fall. Retailers looking to order additional free materials—including a digital age verification calendar—can do so via FDA’s Tobacco Education Resource Library.”  
  • The American Hospital Association News tells us,
    • “The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance changes over time to help assure the devices remain safe and effective throughout their life cycle. The FDA is accepting comments at www.regulations.gov until Dec. 1. The notice follows a request by the Office of Science and Technology Policy issued Sept. 26 that seeks feedback on federal regulations that hinder AI development, deployment or adoption.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has expanded its early alert communication initiative to cover potentially high-risk removals or corrections for all medical devices, the agency said Monday.
    • “Officials announced a pilot of the initiative late last year. Since then, the agency has issued early alerts shortly after companies have told customers about issues with certain medical devices. 
    • “The FDA said the pilot was successful, leading it to expand the program beyond the initial five therapeutic areas and include potentially high-risk safety events of all medical devices.”
  • BioPharma Dive points out five FDA decision to watch for in the fourth quarter of 2025. “The agency is set to decide by the end of the year whether to approve an obesity pill, a new kind of kidney disease drug and a long-awaited heart medicine.

From the public health and medical / Rx research front,

  • STAT News interviews “Lilly’s head scientist [about] its GLP-1 pill, Alzheimer’s strategy, and finding promising ideas and startups. CSO Daniel Skovronsky’s long-term vision: ‘We’re trying to invest in the babies’” 
  • Biopharma Dive reports,
    • “Metsera’s top obesity drug succeeded in a Phase 2 trial, helping enrollees treated with the highest dose lose an average of 14 percentage points more of their body weight than placebo recipients after 28 weeks, the company said Monday.
    • “Interim results from a separate trial also showed that a step-up, or “titrated,” dosing regimen limited the kind of gastrointestinal side effects that often lead people to stop taking GLP-1 drugs for obesity. That finding suggested Metsera’s drug, MET-097i, could have a tolerability profile “better than tirzepatide,” which Eli Lilly sells as Zepbound for weight loss, wrote Leerink Partners analyst David Risinger in a Tuesday client note.
    • “The announcement comes one week after Pfizer reached a deal to acquire Metsera for $4.9 billion. The buyout puts Pfizer back in the chase to develop obesity drugs, a market that could be worth more than $100 billion a year in sales by the next decade.”
  • Per Fierce Pharma,
    • “Two clinical trials of Merck’s pulmonary arterial hypertension (PAH) drug Winrevair were so conclusive that the studies were halted within the last year because the efficacy of the treatment was assured.
    • “Tuesday, Merck reported results from the phase 3 Hyperion study, which showed that Winrevair, when combined with background therapy, achieved its primary endpoint by reducing the risk of clinical worsening events by 76% compared with placebo in recently diagnosed adults.”
  • Per MedPage Today,
    • “Gabapentin prescribing rose sharply in recent years, with the generic drug becoming the fifth most dispensed product in retail pharmacies in 2024, a CDC analysis showed.
    • “From 2010 to 2024, prescriptions jumped from 79.5 to 177.6 per 1,000 people, according to Gery Guy Jr., PhD, of the CDC National Center for Injury Prevention and Control, and co-authors.
    • “The number of persons who received gabapentin soared from 5.8 million in 2010 to 15.5 million in 2024, Guy and colleagues reported in Annals of Internal Medicine. That represented an increase from 18.9 per 1,000 people in 2010 to 46.9 per 1,000 people in 2024.” * * *
    • “Gabapentin is approved for seizures and postherpetic neuralgia; gabapentin enacarbil is approved for restless legs syndrome. Despite limited indications, gabapentin and its cousin pregabalin are widely prescribed off-label for various other pain syndromes.
    • “Common side effects of gabapentin include drowsiness, dizziness, blurry or double vision, and difficulty with coordination and concentration. In 2019, the FDA warned about serious breathing problems that may occur in patients using gabapentin or pregabalin who have respiratory risk factors. These factors included taking opioids or other drugs that depress the central nervous system, conditions like chronic obstructive pulmonary disease that reduce lung function, and older age.”
  • Per Health Day,
    • “An invisible storm might rage for years inside the bodies of people at risk for rheumatoid arthritis, prior to any joint pain occurring, a new study says.
    • “These folks experience dramatic immune system changes long before they feel symptoms, researchers reported in the journal Science Translational Medicine.
    • “Overall, we hope this study raises awareness that rheumatoid arthritis begins much earlier than previously thought and that it enables researchers to make data-driven decisions on strategies to disrupt disease development,” senior researcher Mark Gillespie, an assistant investigator at the Allen Institute in Seattle, said in a news release.”
  • Pulmonary Advisory informs us, “Asthma risk in women has significant associations with body mass index (BMI), body roundness index (BRI), and white blood cell count (WBC), according to study findings published in BMC Pulmonary Medicine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cardinal Health CAH is building a flagship pharmaceutical distribution center in Indianapolis to keep up with its growing customer base and the shifting needs of drug companies.
    • “The planned 230,000 square-foot plant is the healthcare company’s latest step in a 10-year plan to modernize and expand its distribution network. Pharmaceutical distribution remains Cardinal’s most lucrative business, and it is continuing to gain customers. The Dublin, Ohio, company added more than $10 billion of new business in the last fiscal year, said Debbie Weitzman, chief executive of Cardinal’s pharmaceutical and specialty solutions business.
    • “That comes with it a lot of volume that we need to be prepared for,” she said.”
  • Fierce Healthcare relates,
    • “Millie, a California-based hybrid women’s health clinic, is expanding its offerings with perimenopause and menopause care.
    • “The offering, available in person and virtually, includes hormone therapy, nonhormonal treatments, vaginal treatments and lifestyle strategies. Millie currently has two clinics in the Bay Area.
    • “The company, which launched in 2022, was originally focused on maternity care. Staffed with nurse-midwives and doulas, Millie provides care for low-risk pregnancies out of its clinic. Millie also partners with hospitals, where its providers support labor and deliver babies. Midwives drive lower caesarean section rates and higher patient satisfaction scores and can help fill crucial gaps in obstetrics care. As of 2024, more than a third of U.S. counties were designated maternity care deserts. 
    • “In 2023, Millie introduced preconception counseling and gynecology offerings, recognizing that optimizing these areas of health can support better maternal and overall health outcomes. It has now further expanded its continuum of care with menopause care, since many of its patients are becoming parents in their late 30s and navigating postpartum and perimenopause at the same time.” 
  • Beckers Hospital Review shares “the days cash on hand at 40 health systems as of June 30, according to their most recent financial reports.”
  • Beckers Payer Issues offers eight things to know about catastrophic health claims.

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Democrats made their case to President Trump for restoring billions of dollars in healthcare spending as part of any deal to avoid a government shutdown, but they said there was no breakthrough in talks, further dimming hopes of a last-minute deal.
    • “It was a frank and direct discussion” with the president and Republican leaders, “but significant and meaningful differences remain,” said House Minority Leader Hakeem Jeffries (D., N.Y.) after leaving the meeting at the White House.” * * *
    • “The open question headed into Monday’s meeting was whether Trump the dealmaker would show up, or if he was content to let Democrats go home empty-handed. Trump believes he is in a strong position and that Democrats will be blamed for shutting down the government, according to allies. A Republican close to the talks said that while Trump likes to be a dealmaker, there may not be much of a deal to be made.
    • “[Senate Minority Leader Chuck] Schumer [D., N.Y.] and Senate Majority Leader John Thune (R., S.D.) have signaled any deal would likely focus on extending health-insurance subsidies. Those enhanced Affordable Care Act tax credits, first passed in 2021 by Democrats, are set to expire at year’s end. Democrats and some Republicans want an extension, but Republicans are seeking some new income limits on who receives subsidies. They also say discussions should only take place after Congress passes the stopgap bill keeping the government funded through late November.
    • The Senate was set to vote again before the Wednesday deadline on the same GOP bill that Democrats had previously rejected. Republicans have a 53-47 majority, but they need 60 votes to pass most legislation. With the House out this week, that is currently the only option available.
  • Modern Healthcare adds,
    • “The federal government is on track to shut down at midnight EST Wednesday, when fiscal 2026 begins. President Donald Trump and the Republican-led Congress have failed to enact annual appropriations bills to finance government operations. Negotiations with Senate Democrats continued Monday.
    • “Medicare, Medicaid, the Children’s Health Insurance Program and the federal health insurance exchanges would continue operating for the immediate future, HHS announced. The first three programs are mandatory and not subject to annual appropriations and CMS would cover exchange expenses with insurance company user fees.”
  • Federal News Network reminds us,
    • “Even if an agency doesn’t pay health premiums on time to OPM, federal employees and other enrollees in the Federal Employees Health Benefits (FEHB) program, as well as participants in the Postal Service Health Benefits (PSHB) program, maintain coverage throughout the duration of a shutdown, OPM has said in shutdown guidance.
    • “Those same rules apply to coverage through the Federal Employees Dental and Vision Insurance Program (FEDVIP), the Federal Employees’ Group Life Insurance (FEGLI) program and the Federal Long Term Care Insurance Program (FLTCIP).
    • “While all FEHB and PSHB participants maintain health coverage during a shutdown, those who are excepted or furloughed are not expected to pay health premiums while a shutdown is ongoing. Enrollees, however, will have to make any payments for premiums that accumulate during a shutdown, once the shutdown ends.”
  • Govexec offers part 2 of a series of commentaries about OPM in the second Trump Administration while FedSmith reminds folks about five mistakes to avoid during the upcoming FEHB / PSHB / FedFlex Open Season.
  • Avalere Health calls attention to key health policy actions to watch for during the rest of this year.
  • Mercer Consulting informs us,
    • “The 2026 changes to the Medicare Part D drug benefit passed under the Inflation Reduction Act are generally modest compared to the significant adjustments made in 2025. However, new instructions related to determining the creditable coverage status of prescription drug coverage allow plan sponsors to utilize a revised methodology for 2026. Plan sponsors should review the new methodology as they determine the most suitable one for their particular group health plan.
    • “Prior to Oct. 15 each year, plan sponsors providing prescription drug coverage must notify Part D-eligible individuals enrolled, or seeking to enroll, in their group health plan about whether the plan’s drug coverage is creditable — generally, whether it’s expected to pay, on average, at least as much as the Part D standard prescription drug coverage. Additionally, plan sponsors are required to report the creditable coverage status of their prescription drug plans to the Centers for Medicare and Medicaid Services each year, within 60 days of the plan year’s start.
    • “The IRA significantly enhanced Medicare Part D beginning in 2025, raising concerns among some plan sponsors about whether their drug coverage would remain creditable.  Instructions provided by CMS for 2026 take into account the IRA’s enhancements and increased flexibility in how plan sponsors may determine whether their drug coverage is creditable going forward, updating their Simplified Determination Methodology for 2026. And for the first time, some Health Savings Account-qualifying High-Deductible Health Plans may be able to use the SDM to determine creditable coverage status.”
  • The American Hospital Association News tells us,
    • “The Office of Science and Technology Policy issued a request for information Sept. 26 seeking feedback on federal regulations that hinder AI development, deployment or adoption. The OSTP is requesting comments on regulations across all sectors, including health care, where the underlying assumptions, technical requirements or compliance frameworks may create unnecessary barriers to beneficial AI applications. The agency is accepting comments through www.regulations.gov until Oct. 27.”
  • and
    • “The AHA Sept. 29 sent recommendations to the Department of Health and Human Services and the Centers for Medicare & Medicaid Services to help ensure insurance plans adhere to the agencies’ health insurer pledge to reform prior authorization processes. They include monitoring plans’ progress in fully implementing existing regulations, such as the interoperability and prior authorization final rule and reforms issued in the 2024 Medicare Advantage final rule. “As a result of the enormous detrimental impact that certain prior authorization practices routinely place on patients, physicians and hospitals, the AHA has been actively pushing for reforms in this area for a long time and working with health plans to collaboratively reduce the burdens associated with these programs,” the AHA wrote.”
  • and
    • “The AHA Sept. 29 asked the Trump administration to provide exemptions for health care personnel from the proclamation issued Sept. 19 announcing changes to the H-1B visa program. The proclamation increases the fee to $100,000 for new H-1B petitions filed by employers, as well as implements other restrictions on the entry of certain nonimmigrant workers. Of nearly 400,000 H-1B petitions approved in fiscal year 2024, 16,937 of those, or 4.2% of the total filed petitions, were for medicine and health occupations, and half of those approved petitions were for physicians and surgeons.” 
  • The Labor Department’s Bureau of Labor Statistics issued its annual report
    • “Seventy-two percent of private industry workers had access to medical care plans and 45 percent of workers participated. Dental care was available to 30 percent of private industry workers in establishments with less than 100 workers, 50 percent of private industry workers in establishments with 100-499 workers, and 70 percent of private industry workers in establishments with 500 workers or more. Vision care benefits were available for 21 percent of workers in establishments with less than 100 workers, 34 percent of private industry workers in establishments with 100-499 workers, and 44 percent of private industry workers in establishments with 500 workers or more. on employee benefits in the United States.
  • Per Beckers Payer Issues,
    • “The National Committee for Quality Assurance has named Vivek Garg, MD, as its next president and CEO, effective Jan. 5.
    • “Dr. Garg succeeds NCQA founder and current president Margaret O’Kane, who will retire at the end of this year. He currently serves as chief medical officer at Humana’s CenterWell Senior Primary Care.
    • “Dr. Garg previously held leadership positions at CareMore and Aspire Health, Oscar Health and One Medical Group.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively. 
    • “As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
    • “Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers. 
    • “The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.”
  • and
    • “Johnson & Johnson’s Tremfya continues to expand its reach as now the FDA has approved the IL-23 inhibitor as a treatment for two pediatric patient populations.
    • “The agency endorsed Tremfya as a treatment for children 6 years and older who weigh at least 40 kg (88 pounds) with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
    • “In addition, children 6 and older with active psoriatic arthritis are now eligible for the drug, provided they weigh at least 40 kg, J&J said in a Sept. 29 release.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “About 58 million pounds of corn dogs and other sausage-on-a-stick products were recalled across the U.S. because pieces of wood may be embedded in the batter. (AP)
    • Meanwhile, supermarket chain Albertsons recalled several of its store-made deli products because they may contain Listeria, shortly after federal health officials warned consumers not to eat certain pasta meals sold at Walmart and Trader Joe’s over Listeria concerns. (AP)
  • and
    • “Widespread HPV vaccination slashed infection risk and delivered protection for vaccinated and unvaccinated adolescent girls and young women alike, according to a cross-sectional analysis of six regional surveillance studies.
    • “Between 2006 and 2023, the adjusted proportion of vaccinated women in the six studies who were positive for the high-risk HPV-16 and HPV-18 types covered by the first FDA-approved 2-valent HPV vaccine (2vHPV) dropped 98.4%, said Jessica Kahn, MD, MPH, of Albert Einstein College of Medicine in New York City, and colleagues.
    • “In the 17-year period, the proportion of vaccinated women who tested positive for HPV types covered by the later 4-valent vaccine (4vHPV) dropped 94.2% and fell 75.7% for types covered by the current 9-valent vaccine (9vHPV).
    • “Those declines were paired with evidence of herd protection. The proportion of unvaccinated adolescent girls and young women who were positive for at least one HPV type covered by 2vHPV dropped 71.6%. The proportion positive for at least one HPV type covered by 4vHPV fell 75.8%, they noted in JAMA Pediatrics.”
  • and
    • “In the Southern Hemisphere, the adjusted flu vaccine effectiveness rates against outpatient visits and hospitalizations were 50.4% and 49.7%.
    • “Only 21.3% of flu outpatients and 15.9% of hospitalized flu patients were vaccinated.
    • “Health authorities in the Northern Hemisphere might expect similar levels of protection against influenza, experts said.”
  • STAT News notes,
    • “Heart attacks, heart failure, and strokes don’t come out of nowhere, a new study concludes. The first time they strike, patients, clinicians, and researchers might think there were no red flags.  
    • “But a prospective cohort study reports that more than 99% of people who experienced these illnesses had at least one of four risks for cardiovascular disease. They had “suboptimal” high blood pressure, cholesterol, or blood glucose, or they were current or former smokers. More than 93% of the more than 9.3 million people in two national cohorts followed for 20 years had more than one risk factor.
    • “Among women under 60, often considered to be at lowest risk, more than 95% had at least one nonoptimal risk factor before heart failure or stroke.
    • “This almost universal prevalence of warning signs is far higher than reported in other studies, the new paper asserted.
    • “Every practicing cardiologist has seen cases in which individuals without any known risk factors sustain an MI or develop significant coronary disease,” Neha Pagidipati of the Duke Clinical Research Institute wrote in a companion editorial, referring to myocardial infarction, or heart attack. “However, the prevalence of CVD without traditional risk factors may be significantly lower than previously described.”
  • MedPage Today adds,
    • “The increase in early-onset cancers is not necessarily due to a rise in clinically meaningful cancers, researchers argued, but may be due to increased diagnostic scrutiny and overdiagnosis.
    • “Of the eight fastest-rising cancers, only two — colorectal and endometrial cancer — have shown a slight increase in early-onset mortality.
    • “For the six other cancers, stable or declining mortality rates alongside rising diagnoses suggest that greater detection (rather than more disease) may account for the trend.”
  • Per Health Day,
    • “Acute cystitis may signal the presence of urogenital cancers in middle-aged adults, according to a study published online Sept. 16 in BMJ Public Health.
    • “Filip Jansåker, M.D., Ph.D., from Lund University in Sweden, and colleagues examined the subsequent risks for urogenital cancers in men and women aged 50 years and older diagnosed with acute cystitis. The analysis included roughly 1.67 million men and 1.89 million women, including 177,736 men and 427,821 women diagnosed with acute cystitis (first event) from 1997 to 2018.” * * *
    • “It is plausible that urogenital cancer, and perhaps even precancerous changes in the urogenital organ, might increase the risk of cystitis because of compromised urinary tract and host defense,” the authors write.”
  • Genetic Engineering and Biotechnology News relates
    • “Bispecific antibodies and chimeric antigen receptor (CAR) T cells demonstrate potent cancer immunotherapy in clinical use, yet most cancers remain poorly targetable. High-affinity antibodies needed to maximize cancer killing also detect low antigen expression in normal tissue, which causes toxicity in healthy tissue. Identifying cancer-restricted cell-surface protein antigens remains an ongoing challenge. 
    • “In a new study published in Cell titled, “Safe immunosuppression-resistant pan-cancer immunotherapeutics by velcro-like density-dependent targeting of tumor-associated carbohydrate antigens,” researchers from the University of California (UC), Irvine, have reported that targeting cancer-associated glycans with binding proteins can trigger tumor cell death without toxicity to surrounding tissue. The biologically engineered immunotherapies, known as glycan-dependent T cell recruiter (GlyTR) compounds, were shown to be safe and effective in models for a spectrum of cancers, including breast, colon, lung, ovaries, pancreas and prostate. 
    • “It’s the holy grail—one treatment to kill virtually all cancers,” said Michael Demetriou, MD, PhD, a professor of neurology, microbiology and molecular genetics at the UC Irvine School of Medicine and corresponding author of the study. “GlyTR’s velcro-like sugar-binding technology addresses the two major issues limiting current cancer immunotherapies: distinguishing cancer from normal tissue and cancer’s ability to suppress the immune system.”

From the healthcare business front,

  • STAT News reports,
    • “Perimenopause is the new buzzword in the business of women’s health.
    • “The menopause market has proved so successful that companies are increasingly pushing products aimed at younger women too.”
  • Beckers Hospital Review breaks down the massive 138-hosptial Common Spirit health system’s revenue by region for the fiscal year ending June 30 in 2025 and 2024.
  • MedPage Today points out,
    • “Among more than 3 million Medicare Advantage enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes.
    • ‘The mean score differences for blood glucose control and blood pressure control indicated “markedly better performance” with value-based payment models.
    • “Clinical quality performance consistently improved as financial arrangements moved toward 2-sided risk sharing.”
  • The Brown & Brown consulting firm discusses “Practical Approaches for Employers to Manage High-Cost Claimants in Health Plans.”
    • “Managing high-cost claimants requires a delicate balance of cost control, care quality and employee experience. Employers who invest in data-driven decision making, proactive care management and thoughtful plan design are best positioned to reduce the financial impact of high-cost claimants without sacrificing the well-being of their workforce.
    • “By taking a strategic and holistic approach, employers can turn a major cost challenge into an opportunity to enhance healthcare delivery, improve outcomes and foster a healthier, more productive employee population.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “today that it will assess the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Novavax) for the prevention of COVID-19, including both the short- and long-term effects of the infection.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in June 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The Wall Street Journal reports,
    • “Novartis NOVN said it is launching a direct-to-patient platform in the U.S. to sell a discounted version of its Cosentyx drug, the latest big pharma company to move to cut prices ahead of the Trump administration’s deadline.
    • “The Swiss pharmaceutical company said Monday that it would offer select units of Cosentyx—a drug treating immune-mediated inflammatory conditions like psoriasis and psoriatic arthritis—at a 55% discount to cash-paying patients with a prescription. The platform will come into effect on Nov. 1.
    • “Novartis’s launch of a direct-to-patient platform and the discount comes after President Trump said in a letter to pharmaceutical companies in July setting a deadline of Sept. 29 to impose cuts on drug prices.”
  • Fierce Pharma adds,
    • “As pharma companies face an imminent deadline from President Donald Trump related to his “Most Favored Nation” (MFN) drug pricing demands, the industry’s top U.S. lobbying group is touting three “major actions” by its members and calling for some policy shifts of its own.
    • “The timing of the Sept. 29 press release by the Pharmaceutical Research and Manufacturers of America (PhRMA) coincides with the deadline set by the president when he laid out the steps pharma companies “must take” to align certain U.S. prices with lower prices overseas. 
    • “But rather than directly addressing the core component of Trump’s demand, the PhRMA communication centers on its members’ infrastructure spending, patient financial assistance programs and a new website designed to compile drugmakers’ direct sales offerings.
    • “PhRMA members are planning $500 billion in U.S. investments over the next 10 years, including $100 billion in projects that haven’t been announced yet, PhRMA CEO Steve Ubl wrote in an accompanying Washington Post op-ed piece Monday.
    • “Besides the capital projects, the industry trade group also plans to launch a website compiling its members’ direct sales offerings. Over the last several months, Big Pharma players have been rolling out new direct-to-patient sales platforms that offer cash-paying patients steep discounts to list prices for certain medicines. This is one component of the president’s push to rein in U.S. prices, and pharmaceutical companies are happy to stick it to middlemen in the U.S. whenever possible.”
  • Per BioPharma Dive,
    • “Antibody drug specialist Genmab on Monday agreed to acquire Dutch biotechnology company Merus in an $8 billion deal centered around a drug that’s shown potential treating head and neck cancer.
    • “Per deal terms, Genmab will pay $97 per share in cash to acquire Merus, representing a 41% premium to the biotech’s closing price on Friday of about $68.  
    • “The deal hands Genmab a drug called petosemtamab and that’s in late-stage testing for head and neck cancer. Phase 2 data presented at the American Society of Clinical Oncology meeting in May showed that the drug helped extend survival when used alongside Merck & Co.’s immunotherapy Keytruda, a result that boosted shares and suggested it could change care for those tumors.”
  • and
    • “Emma Walmsley, the first woman to lead a big pharma company as CEO, will step down from that post Dec. 31, handing the reins of one of Britain’s premier drugmakers to commercial chief Luke Miels.
    • “In a statement Monday, GSK said Walmsley, who has been running GSK since 2017, will depart as part of a succession plan. Miels’ selection was the outcome of a “rigorous process” conducted over the last few months and that included consideration of “internal and external candidates.” He’ll start serving as GSK’s full-time CEO on Jan. 1.
    • “The CEO change ends a nine-year run for Walmsley atop GSK. During that time, Walmsley steered the big drugmaker through a turbulent period, during which it spun out its consumer health business to focus on innovative drugs while facing persistent investor pressure to boost its productivity and growth prospects.
    • “GSK also deepened its investment in oncology, expanded its HIV drug portfolio and brought to market the first vaccine for respiratory syncytial virus.
    • “Yet GSK missed an opportunity during the COVID-19 pandemic, when it decided against developing its own vaccine and partnerships with Sanofi and CureVac hit setbacks and delays.” * * *
    • ‘Miels joined GSK in 2017 after stints at AstraZeneca, Roche and Sanofi, in positions in Europe, Asia and the U.S. He will be paid a base salary of nearly 1.4 million pounds and qualify for bonuses of up to 300%, in addition to other incentives and benefits, according to GSK’s statement.
    • “Walmsley, meanwhile, will also step down from GSK’s board effective Dec. 31, but will remain with the company through Sept. 30, 2026, to support Miels “given the potential impact to GSK’s operating environment arising from geopolitics and new technologies.”

Weekend Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The top four congressional leaders will head to the White House on Monday for a meeting with President Donald Trump in a last-ditch effort to prevent a partial government shutdown.
    • “The meeting, confirmed by sources familiar with the plans, comes after the president scrapped a separate discussion planned with just the two Democratic leaders.” * * *
    • “The Senate is back in session on Monday with 48 hours until agencies would have to start shutting down Oct. 1. The House, which on Sept. 19 passed a partisan GOP-drafted stopgap funding bill that would keep the government operating for seven weeks until the Thanksgiving recess, isn’t planning to return until at least Oct. 7.
    • “Speaker Mike Johnson wrote Friday on X that House Republicans “have done our job” and now it’s the Senate’s turn to act.” 
  • Here is link to the Congressional committee schedule for this week.
  • Roll Call notes,
    • “The Senate does have another option in the queue aside from leadership-driven proposals [for a continuing resolution], with a procedural vote expected Monday on a bill from Sen. Ron Johnson, R-Wis., to provide for automatic two-week continuing resolutions.
    • “My new bill simply provides for automatic two-week rolling continuing resolutions for any department for which an appropriation bill or longer-term continuing resolution hasn’t been passed. This would keep spending flat by prorating the previous year’s spending level,” Johnson wrote in a Sept. 21 Wall Street Journal opinion piece.”
  • SCOTUSblog informs us,
    • “Edward Lazarus, a former clerk to the late Justice Harry Blackmun, called it a “single marathon session.” Gregory Garre, who served as the U.S. solicitor general during the George W. Bush administration, described it as the place “where petitions go to die.” Lazarus and Garre were both referring to the “long conference” – a private meeting, taking place this year on Sept. 29, at which the justices will consider the roughly 2,000 petitions for review that have built up since their last regularly scheduled conference (on June 26) before their summer recess.
    • “The long conference is the unofficial start to the court’s new term, which by law officially begins on the first Monday in October. The tradition of a “long conference” at the end of September or in early October, before the justices take the bench to hear oral arguments, dates back to the early 1970s, according to a book by the late Chief Justice William Rehnquist. Until then, the court held its long conference during the first week in October and had oral arguments thereafter. But Blackmun suggested that the court should move its meeting to the last week in September, allowing it to begin oral arguments on the first Monday in October instead.”
  • Modern Healthcare lets us know,
    • “Medicare Advantage enrollment could slip next year, the Centers for Medicare and Medicaid Services announced Friday.
    • “Health insurance companies project Medicare Advantage membership will fall from 34.9 million this year to 34 million in 2026, CMS said in a news release. 
    • “That would mark the first annual decline in Medicare Advantage enrollment since at least 2007, according to CMS data analyzed by the health policy research organization KFF. The annual enrollment period runs Oct. 15-Dec. 7.
    • “Insurers also predict that Medicare Advantage will lose ground to fee-for-service Medicare next year. The privatized program surpassed traditional Medicare in 2023 but will cover 48% of beneficiaries in 2026, down from 50% this year, according to industry estimates reported to CMS.
    • “CMS offered a rosier assessment. “Based on recent historical experience and enrollment trends, CMS anticipates that enrollment in [Medicare Advantage] in 2026 will be more robust than the plans’ projections and that enrollment will be stable,” the agency said in the news release.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has granted de novo classification to a continuous glucose monitor made by Biolinq for people with Type 2 diabetes.
    • “Biolinq says its device is the first CGM that does not require a needle to place the sensor beneath the skin, instead using a microsensor array that sits less deep in the skin.
    • “People with diabetes have a growing number of CGM options as the FDA has authorized new sensors in recent years, including the first over-the-counter sensors and implanted CGMs that can be worn for one year.“
  • P.S. The OPM Director did not add a new post to his Secrets of OPM blog on Friday.

From the public health and medical / Rx research front,

  • Healio tells us,
    • “A federal law required all new cars to be equipped with backup cameras after May 2018.
    • “The mandate was associated with a 62% reduction in back over injuries in a trauma center in Houston.”
  • and
    • “COVID-19 vaccination during pregnancy provides significant protection for mothers and their babies with no associated increase in risk, according to data from more than 1.2 million pregnancies presented at the AAP’s annual meeting.
    • “COVID-19 vaccination reduced admission, mortality and pregnancy-specific complications,” Nikan Zargarzadeh, MD, a postdoctoral research fellow in the division of fetal medicine and surgery at Boston Children’s Hospital, told reporters on Saturday. “On the neonatal side, it reduced NICU admission.”
  • and
    • “Many women suffer complications in the time between giving birth and the 6-week visit.
    • “A Women in Medicine Summit presenter discussed how her own journey informs her work and what she is doing to help new moms.”
  • NPR Shots reports,
    • “For more than four years, Lynn Milam’s life was bound by the pain that radiated from her swollen joints.
    • “My children could not hug me,” she says. “I couldn’t hold my husband’s hand.”
    • “Milam also couldn’t climb stairs or help raise her teenage son. She spent most days on the couch.
    • “The reason was rheumatoid arthritis, which occurs when the immune system starts attacking the lining of joints.
    • “Milam tried everything: physical therapy, acupuncture, steroids and even the latest immune drugs. Nothing worked.
    • “That changed in October of 2023, when a surgeon implanted an experimental device in Milam’s neck. For a minute each morning, it delivers pulses of electricity to her vagus nerve, which connects the brain with internal organs.
    • “Three weeks in, my elbow pain was completely gone,” she says. “Then my hands didn’t hurt anymore, the swelling started going away.”
    • “Eventually, all symptoms of rheumatoid arthritis had vanished. Milam, 60, says she and her husband have regained the life they enjoyed before she got sick.”
  • Per Medscape,
    •  “Tirzepatide was associated with improvements in body weight and body composition, and with lower insulin doses, in the first-ever randomized controlled trial (RCT) of the drug in people with type 1 diabetes (T1D).
    • “Tirzepatide may play a role in weight management in adults with T1D and obesity, even at low doses,” Jennifer R. Snaith, MD, of the Garvan Institute of Medical Research and St. Vincent’s Hospital Sydney, both in Darlinghurst, Australia, said at European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.” * * *
    • [A]sked to comment, independent industry consultant Charles Alexander, MD, noted that, while the data look good, it’s a small study and that Lilly’s two much larger ongoing phase 3 trials of tirzepatide in T1D, SURPASS-T1D-1 (NCT06914895), and SURPASS-T1D-2 (NCT06962280), aimed at obtaining FDA approval, will produce more definitive results.
    • Alexander also pointed out that Novo Nordisk is not conducting a similar RCT of semaglutide in T1D. “At the end of the day,” if it’s approved, “all you’re going to have [in terms of incretin drugs] is tirzepatide licensed for T1D.” 
    • Snaith’s team is also conducting a further study, TIRTLE2, with insulin resistance as the primary outcome.

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Amid rising healthcare costs, Amazon announced benefit updates Sept. 17 that include a “reduced-cost” healthcare plan for its fulfillment and transportation employees. Workers on the plan will only need to pay $5 a week and $5 for copays starting in 2026.
    • “Those costs amount to about $22 per month or $260 per year for employees. This results in reductions of weekly contributions by workers by 34% and copays for primary care, mental health and nonspecialist visits by 87%, Amazon said.
    • “The changes were made based on feedback offered by workers, Udit Madan, senior vice president of Amazon Worldwide Operations, said in the announcement.”
  • Fierce Pharma notes,
    • “Serial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterprises as Lotus Pharmaceuticals has acquired a 100% equity stake in [U.S. based] Alvogen.
    • “The move, which transforms Alvogen into a subsidiary, catapults Taiwan-based Lotus into a top-20 specialty pharmaceutical company worldwide, according to a release. The deal has a total value of up to $2 billion.
    • The deal could also help shield Lotus—which does most of its business in Asia—from U.S. tariffs on pharmaceutical products. Thursday night, in a post on social media, President Donald Trump wrote that starting Oct. 1, the U.S. would impose a 100% levy on drugs imported by companies that aren’t in the process of building U.S. facilities.
    • “The transaction gives Lotus “access to U.S. R&D, manufacturing and commercial capabilities alongside our established strengths in Asia,” the company said in a release.”

Friday report

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

From Washington, DC,

  • Govexec tells us,
    • “Federal employees have been asking a lot of questions since the White House put out guidance this week suggesting large swaths of them would face layoffs under a government shutdown if one occurs next week.
    • “So far the answer many of them are getting is: we are planning to send you home without pay, but only until the shutdown ends. That is to say, agency officials are telling employees they will face their normal shutdown furloughs, but not reduction-in-force notices. 
    • “We were told we won’t be RIF’d, regardless of whether we have to work,” said one General Services Administration employee, whose office is typically furloughed during a funding lapse. 
  • The Centers for Medicare and Medicaid Services announced,
    • [A]verage premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026.
    • CMS is committed to ensuring these programs work for Medicare beneficiaries while maintaining access to high-quality, affordable healthcare options, safeguarding taxpayer dollars, and making sure beneficiaries have the information they need to make informed choices about what is best for them. 
    • CMS releases this key information, including 2026 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2025, to December 7, 2025.
    • “Millions of Medicare beneficiaries will continue to have access to a broad range of affordable coverage options in 2026,” said CMS Administrator Dr. Mehmet Oz. “We want every beneficiary to take advantage of Open Enrollment—compare your options and choose the plan that gives you the right care at the best price.”
  • The American Hospital Association News informs us,
    • President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building its pharmaceutical manufacturing plant in America. The president’s post on Truth Social said “is building” will be defined as “breaking ground” or “under construction” and that there would be no tariff on “these Pharmaceutical Products if construction has started.”   
    • As of 3 p.m. ET on Sept. 26, the administration has not released any official documents related to the tariff announcement.  
  • BioPharma Dive adds,
    • “The new pharmaceutical tariffs President Donald Trump announced on Thursday, which will go into effect on Oct. 1, could have a limited impact on the pharmaceutical industry due to multiple exemptions for generics, exports from Europe and companies already onshoring manufacturing.
    • “The tariffs, unveiled via a post on the social media platform Truth Social, haven’t been accompanied by legal documents, leaving key details unclear. However, the 100% levies, which are much smaller than the figure previously floated by the Trump administration, alleviate some uncertainty around U.S. drug pricing policy.
    • “The announcement comes days before the expected release of programs meant to align U.S. drug prices with what’s paid in Europe and elsewhere. Published reports have suggested those policies may be more modest than Trump originally proposed, however.”
  • FedWeek points out,
    • “A new bipartisan group of House members has been formed with a focus on the impact on jobs and delivery performance of the Delivering for America reorganization initiative.
    • “The Congressional Postal Service Caucus will focus on improving on-time delivery rates, protecting postal employees, and stopping harmful facility consolidations that reduce access in rural and underserved areas,” said a statement from the founding members. A caucus is a less formal organization than a congressional committee, typically focusing on issues—and trying to build consensus on them—that cross committee areas of jurisdiction.”
  • NCQA, writing in LinkedIn, lets us know about NCQA researchers sharing findings on emerging topics in health care.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza and RSV activity is low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. The percentage of emergency department visits for COVID-19 are highest in children 0-4 years old. Hospitalization numbers and the percentage of emergency department visits are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is low nationally.
  • The University of Minnesota CIDRAP adds,
    • “The current COVID wave began in June, marked by a slow rise that never approached levels seen last summer.
    • “Wastewater SARS-CoV-2 detections are now at the moderate level and are highest in Northeast, followed by the West and the South.”
  • Prevention notes,
    • “The Stratus COVID variant, a.k.a. XFG, is currently the dominant strain of the virus in the U.S., causing 78% of cases in the country, according to CDC data.
    • “It’s an Omicron variant, and it’s a hybrid of two strains—LF.7 and LP.8.1.2,” says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
    • Stratus has several mutations to the spike protein, which the virus uses to infect your cells and make you sick, per the World Health Organization (WHO). But the WHO also notes that the threat posed by Stratus is “low.”
  • The Wall Street Journal reports,
    • “President Trump’s return to office has supercharged the debate about childhood vaccinations. Trump himself recently stated that “children get these massive vaccines…like you give to a horse…they get like 80 vaccines,” while Health Secretary Robert F. Kennedy Jr. asserts that babies get up to 92 vaccine doses. In justifying Florida’s decision to end mandatory vaccine mandates for children, state surgeon general Joseph Lapado asked: “Who am I to tell you what your child should put in [their] body? I don’t have that right.”  
    • “These statements misstate the amount and number of vaccines administered to children. Over the course of 18 years, it’s typically 30 doses—in quantities about a tenth of a teaspoon—for about 16 different pathogens. But the critics raise important questions that parents have every right to ask. Why give vaccines so early in a baby’s life? And why shouldn’t parents just pick and choose what goes into their child?  
    • “The crucial context for this discussion is two facts. First, vaccines constitute only a minuscule fraction of the exposure to pathogens that children’s immune systems must contend with. Second, our bodies develop the most enduring antibodies in the early years of life.”
  • JAMA relates,
    • “For years, most observers attributed the higher number of Alzheimer disease cases among women to the simple fact that they live longer than men on average.
    • “Recently, though, scientists have come to recognize that the explanation for the sex gap in the prevalence of Alzheimer disease, the cause of most cases of dementia, is far more nuanced and complex, involving both biological and sociocultural factors.
    • “Research has focused on such potential contributors as women’s exposure to sex hormones, the genes in the X chromosome, the prevalence and effect of risk factors such as hearing loss, the apolipoprotein E ε4 (APOE4) variant, and diminished cognitive reserve related to lower education levels.
    • “Approximately 2 out of every 3 people living with Alzheimer disease in the US is a woman, Harvard neuropsychologist Rachel Buckley, PhD, noted. “Women actually tend to live with dementia for much longer than men.”
  • Per Health Day,
    • “An experimental pill can significantly reduce hot flashes and night sweats for women after menopause a new clinical trial has determined.
    • “Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.
    • “Further, this relief lasted for a year, the trial found.
    • “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.”
  • and
    • “Routine screening can help find kids who are suffering from undiagnosed asthma in communities with high levels of the breathing disorder, a new study says.
    • “Asthma screening during well-child visits found that more than two-thirds (35%) of children with no previous diagnosis of asthma had at least one risk factor for the disease, researchers will report Monday at an American Academy of Pediatrics’ meeting in Denver.
    • “Further, about 24% of kids with risk factors were subsequently diagnosed with asthma, researchers said.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Commercially insured patients pay substantially different rates for the same procedure, with negotiated costs for inpatient procedures varying by an average ratio of 9.1, according to an August report from market intelligence firm Trilliant Health.
    • “The report reviewed health plan transparency data from Aetna and UnitedHealthcare, focusing on 11 inpatient and outpatient procedures.
    • “A coronary bypass without cardiac catheterization, excluding major complications or comorbidities, had negotiated rates ranging from $27,683 to $247,902. Another finding: Outpatient procedures at ambulatory surgery centers would often cost less than those taking place in a hospital’s outpatient department. Colonoscopies, for example, would cost 67.5% less on average than the median hospital rate.
    • “By reviewing a sample of 10 hospitals featured on a collection of “best hospitals” rankings, the researchers also found no correlation between cost and quality.”
  • and
    • “Regional, nonprofit health plans are falling behind large national insurers, with 71% recording an operating loss in 2024 and more than half having two years or less before regulatory intervention is triggered, according to a Sept. 24 report from HealthScape Advisors.
    • “Executives and boards of directors now face the most important decision of their leadership tenures: How do we survive?” the report said.” 
  • Kauffman Hall explains,
    • “The rise of ambulatory surgery centers (ASCs) marks a shift in how surgical care is delivered across the U.S. Amid soaring healthcare costs, tighter reimbursement and advancing surgical technology, health systems are rethinking where and how procedures are done. Many are moving complex surgeries like total joint replacement and spine out of hospitals and into ambulatory settings. Once limited in scope, ASCs are becoming key players in strategically important service lines like orthopedics.” * * *
    • “ASCs are not a magic wand for health systems. While they offer savings to payers, the economics are fragile for providers. Healthy margins require lean operations, smart sourcing and trusted partnerships.
    • “There’s a growing demand for more complex procedures in outpatient settings, but ASCs need to strategically position themselves to meet this demand in an operationally and financially sustainable way.
    • “With advances in surgical technology and care coordination, ASCs are ready to deliver on the promise of value-based care. The challenge for health systems isn’t just to shift where care is delivered, but to rethink how surgical care is structured, managed and financed for long-term performance.”
  • Optum, writing in LinkedIn, discusses how “breakthrough cancer drugs offer better outcomes – but soaring costs pose challenges.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it will offer its asthma and diabetes drugs at an up to 70% discount in the U.S. ahead of a Trump administration deadline for pharmaceutical companies to cut drug prices.
    • “The company said it would launch a direct-to-consumer platform on which eligible patients with prescriptions will be able to purchase its Airsupra and Farxiga drugs in cash at a discount. The platform will be available beginning Oct. 1.
    • “In July, President Trump sent pharmaceutical companies a letter setting a Sept. 29 deadline to propose cuts to their drug prices.
    • “In response, several drugmakers have rolled out direct-to-consumer platforms to offer discounted drugs. Earlier this week, Bristol Myers Squibb said it would offer its plaque psoriasis drug at an up to 80% discount, expanding on its discounted program for blood clot drug Eliquis, which it announced in July.”
  • Fierce Pharma adds,
    • “In an expansion of its previous moves to cut insulin prices, Sanofi will cap the price of each of its insulin products at $35 per month in the U.S. regardless of a patient’s insurance status.
    • “The move, which goes into effect at the start of next year, comes two years after the company slashed the price of its most popular insulin, Lantus, to $35 monthly for those with commercial insurance.
    • “Before that, in June of 2022, Sanofi reduced the price of an unbranded Lantus biologic from $99 per month to $35 for those in the U.S. without insurance.
    • “Sanofi’s cost-cutting efforts have mirrored those of the world’s other two primary sellers of insulin—Novo Nordisk and Eli Lilly—and come as advanced insulin products and insulin biosimilars are reaching the market.”