Friday report

OPM

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.

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.”

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.”

Thursday report

David Ermer–CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The U.S. government is hurtling toward a shutdown in a matter of days with no exit ramp in sight, as Republicans and Democrats latch onto starkly different positions and the White House threatens to lay off more federal workers.
    • “Republicans are seeking a seven-week extension in federal funding at current levels, and they have dismissed Democrats’ demands for hundreds of billions of dollars in healthcare spending. In a move to raise the political pressure, President Trump’s budget chief late Wednesday vowed to use any lapse in funding to make deeper cuts in the federal workforce, a threat Democrats rejected as blackmail.
    • “Democrats see the funding deadline as a rare opportunity to shape legislation, and the party’s base voters are desperate for elected representatives to show more fight after months of demoralizing political defeats. Republicans are loath to offer any concessions, putting both parties on a collision course ahead of the Oct. 1 deadline.
    • “Democrats have “asked us to do something that’s totally unreasonable,” President Trump told reporters on Thursday. Asked about the possibility of a shutdown, he said: “Could be. Because the Democrats are crazed. They don’t know what they are doing.”
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) has said he plans to stand firm this time and demand bipartisan talks, rather than acquiesce to a Republican plan to keep the government open, like he did in March. He said Democrats won’t be intimidated by the latest threat of federal layoffs.
    • “This is one of their threats, and their threats are not going to succeed,” Schumer said in an interview. “A lot of my colleagues who I’ve talked to today are very angry about this.”
  • Per Roll Call,
    • “Sources on both sides of the aisle and nonpartisan analysts agreed that, beyond the tough talk, top congressional Democrats have a weak hand to play and no discernible strategy for extracting the concessions from President Donald Trump and GOP leaders that they want on health care policy.
    • “A shutdown for the sake of a shutdown doesn’t help anyone,” a former Democratic congressional aide granted anonymity to speak candidly said. “If there is a shutdown, there also needs to be a plan to get out of it — and it will require a deal on all sides to end it, at a time when tensions would be even higher. It’s hard to turn back to bipartisan negotiations after that.”
  • Federal News Network adds,
    • “The Trump administration is taking a more aggressive approach than usual to what would happen in a government shutdown, after a White House memo Wednesday night told agencies to plan for further reductions in force if government funding lapses early next week.
    • “But with just days left before a government shutdown, many are questioning the ability for agencies to put together further RIF plans at all, since the reduction-in-force process is typically complicated and time-consuming, often taking months or longer.”
  • Bloomberg reports,
    • “The US will impose a 100% tariff on branded or patented pharmaceuticals, President Donald Trump announced Thursday.
    • “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America,” Trump said in a social media post.
    • “Trump said there would be no tariffs on pharmaceutical products if companies have broken ground on a US manufacturing plant, or if such a plant is under construction.”
  • and
    • “Pharmacy middlemen are working on a proposal to voluntarily change some of their business practices to avoid new regulation from the Trump administration.
    • “The proposals under discussion include ensuring patients don’t pay more than a pharmacy would charge to someone without insurance and increasing the use of lower-cost versions of expensive biologic drugs.
    • “The Pharmaceutical Care Management Association has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News.”
  • The American Medical Association adds,
    • “The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective equipment, medical consumables and medical equipment under Section 232 of the Trade Expansion Act of 1962. The provision authorizes the president to impose tariffs or other trade restrictions if an investigation determines that the importation of particular goods affects national security. The department is seeking comment on a range of criteria, including the current and projected demand for PPE, medical consumables and medical equipment; the extent to which production can meet demand; the role of foreign supply chains in meeting U.S. demand; the concentration of U.S. imports of those products and more. Comments are being accepted for 21 days following publication in the Sept. 26 Federal Register.”
  • Bloomberg tops it off with this,
    • “Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
    • “By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.  
    • “The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
    • “A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients.”
  • From ARPA-H news releases
    • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development opportunity through its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program. THRIVE intends to develop integrated platform technologies to accelerate precision genetic medicines (PGMs) and provide single-intervention precision treatments to slow, reverse, or prevent diseases at the genetic level. The program is designed to optimize affordability, scalability, and sustainability of lifesaving PGMs for patients through existing regional treatment centers and virtual clinics. This will allow patients to be seen and treated where they live.” * * *
    • “Learn more about THRIVE on its program page, including information about the solicitation and Proposers’ Day.” 
  • and
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines.” * * *
    • “Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.”
  • Per a U.S. Office of Personnel Management news release,
    • The U.S. Office of Personnel Management (OPM) today announced record levels of engagement and leadership from the Chief Human Capital Officers Council (CHCOC) under the Trump Administration, underscoring the Council’s critical role in driving forward personnel policy and workforce reform across the federal government. The Chief Human Capital Officers Council is the principal interagency forum for federal human capital leaders, bringing together the Chief Human Capital Officers from across the Executive Branch to coordinate policy, share best practices, and advance government-wide workforce initiatives.
    • Since January of this year, the Council has held 71 sessions, an increase of almost double compared to the 40 sessions held last year. These sessions cover everything from discussing the Deferred Resignation Program and return-to-office policies to SES performance and collective bargaining. Between January and March alone, the Council convened 34 times in just 50 workdays. Alongside these sessions, the Council has distributed more than 200 communications to federal agencies this fiscal year, including official memos, weekly updates, and special notices.
  • OPM also recently posted Benefits Administration Letter 25-102 about FEHB Enrollment Coordination for Married Federal Employees and Annuitants.
  • Avalere Health discusses an upcoming meeting at which new ICD-10 codes for 2026 will be selected.

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “Capricor Therapeutics executives came out of a meeting with Food and Drug Administration officials confident that they can reverse a rejection of their experimental cell therapy for Duchenne muscular dystrophy. 
    • “The FDA turned down Capricor’s application for the drug, deramiocel, in July after questioning the research supporting its effectiveness. At the time, Capricor CEO Linda Marbán said the rejection was a surprise and that no major issues had been raised during the review.
    • “Now, FDA officials are indicating that they will reconsider the application with new data from a clinical trial called Hope-3 that’s already been completed, Capricor said Thursday. That’s important because Capricor won’t have to start all over with a new submission. “This is a giant win for us,” Marbán said during a conference call with analysts. Initial trial results are expected in the middle of the fourth quarter.”
  • and
    • “The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation.
    • “Previously known as imlunestrant, the drug has been cleared for use in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. The approval makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1 — an alteration Lilly believes to occur in about half of people with that form of the disease either during, or after, exposure to hormone therapy.
    • “The clearance was based on results published in the New England Journal of Medicine last year. Those findings, from a study called EMBER-3, showed that Inluriyo helped reduced the risk of disease progression or death among those with ESR1 mutations by 38% when compared to standard hormone-suppressing therapies. Inluriyo delayed tumor progression by a median of 5.5 months, or close to 2 months longer than those on typical drugs.”  
  • and
    • “Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
    • “The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said. 
    • “Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.”
  • MedPage Today points out,
    • “A risk evaluation and mitigation strategies (REMS) program is no longer required for the thyroid cancer therapy vandetanib (Caprelsa), the FDA announced on Thursday.
    • “The agency had required the safety program for vandetanib to ensure appropriate heart rhythm monitoring and safe use since its approval in 2011opens in a new tab or window as treatment for medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
    • The approval of vandetanib was based on results from the phase III randomized ZETA trial in which patients randomized to receive vandetanib experienced a 65% reduction in the risk of disease progression compared to patients on placebo. A REMS was required for vandetanib due to potential for QT prolongation and reported cases of torsades de pointes and sudden death in patients taking the drug.
  • Fierce Pharma informs us,
    • “After nearly two decades in the endocrine scene, Crinetics is making its commercial debut with the approval of a game-changing treatment for the rare growth disorder acromegaly.
    • “The FDA on Thursday signed off on Crinetics’ paltusotine—now christened Palsonify—as a first-line treatment for adults with acromegaly for whom surgery didn’t work or isn’t an option.
    • “The drug is a selectively targeted somatostatin receptor type 2 (SST2) agonist. Unlike other somatostatin drugs that make up the bulk of current acromegaly care options, Palsonify is a small molecule, non-peptide therapy that can be taken orally, freeing up patients from frequent and often painful injections.
    • “The treatment marks the “next level of care for patients with acromegaly,” Scott Struthers, Ph.D., co-founder and CEO of Crinetics, said in a recent interview with Fierce Pharma, staking that claim on the drug’s ability to both help control patients’ hormone levels and address their symptoms in a once-daily treatment option.”
  • Per FDA news release,
    • “Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court has tossed a rule outlining how auditors must review Medicare Advantage insurance companies for overpayments, adding uncertainty to the federal government’s plan to audit every plan annually.
    • “On Thursday, Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas in Fort Worth, vacated the 2023 Medicare Risk Adjustment Data Validation, or RADV, rule, on the grounds that regulators violated the Administrative Procedure Act of 1946.”
    • “Under the rule, which was finalized in January 2023, the Centers for Medicare and Medicaid Services eliminated a key statistical tool, the fee-for-service adjuster, used to compare error rates in traditional Medicare versus Medicare Advantage. Regulators planned to apply the new audit method retroactively to insurers’ risk-adjustment code reviews dating back to 2018. When the rule was finalized, CMS estimated that the more stringent reviews would result in insurers returning $4.7 billion to the agency between 2023 and 2032. 
    • “Humana sued over the rule in September 2023, alleging the new audit methodology held private Medicare insurers to a higher standard than the fee-for-service program. 
    • “O’Connor sided with the insurer.  In a Thursday order, he ruled that CMS failed to adequately notify the industry that actuarial equivalence between traditional and Medicare Advantage plans no longer applied.
    • “Because there was no meaningful notice of defendants’ ultimate finding that actuarial equivalence does not apply to RADV audits, there was no meaningful dialogue regarding the costs and benefits of the surprise changes,” O’Connor wrote in the order.” 

From the public health and medical / Rx research front,

  • MedPage Today lets us know,
    • “Women who missed their first screening mammogram had a 53% higher risk of stage III breast cancer over the next 25 years and almost a fourfold higher risk of stage IV breast cancer.
    • “Breast cancer mortality was 40% higher among screening nonparticipants.
    • “Breast cancer incidence was nearly identical, suggesting the increased risk of later-stage diagnosis and breast cancer mortality resulted from delayed detection.”
  • Per Health Day,
    • “During August 2021 to August 2023, only 36.4 percent of U.S. adults had no cardiovascular disease (CVD) risk factors, according to a September data brief published by the National Center for Health Statistics.
    • “Catharine A. Couch, Ph.D., R.D., from the National Center for Health Statistics in Baltimore, and colleagues presented prevalence estimates for none, one, or two or more CVD risk factors (uncontrolled high blood pressure, uncontrolled high blood lipids, uncontrolled high mean blood glucose, and high body mass index) in U.S. adults from August 2021 to August 2023.
    • “The researchers found that 36.4, 34.9, and 28.7 percent of U.S. adults had no, one, and two or more CVD risk factors, respectively. More men than women had two or more CVD risk factors (31.7 versus 25.8 percent). With age, there was a decrease in the percentage of adults with no CVD risk factors, while a higher percentage of older adults had one or two or more CVD risk factors. Those with family income 350 percent or more of the federal poverty level had the highest percentage of adults with no CVD risk factors and the lowest percentage with two or more CVD risk factors. The percentage of adults with two or more CVD risk factors increased from 2013 to 2014 to August 2021 to August 2023.”
  • and
    • “Physical frailty may contribute to the development of dementia, according to a study published online Sept. 17 in Neurology.
    • “Xiangying Suo, from the School of Public Health of Zhengzhou University in China, and colleagues conducted a prospective cohort study based on U.K. Biobank participants without dementia to examine the link between physical frailty and dementia. Five criteria were used to define physical frailty (weight loss, exhaustion, physical inactivity, slow walking speed, and low grip strength).
    • “A total of 8,900 dementia cases were documented during a median follow-up of 13.58 years among 489,573 participants. The researchers found that the risk for dementia was significantly higher in those with prefrailty and frailty compared with nonfrail individuals (hazard ratios, 1.50 and 2.82, respectively). Compared with those with low genetic risk and nonfrailty, the highest risk for dementia was seen for participants with frailty and high genetic risk (hazard ratio, 3.87 for high polygenic risk score; 8.45 for APOE-ε carriers). A potential causal relationship was seen between physical frailty and dementia in the forward Mendelian randomization (MR) analysis (odds ratio, 1.79), while a null causal association was suggested in the reverse MR. Potential underlying mechanisms linking physical frailty to dementia include genetic background and neurologic and immunometabolic function.”
  • BioPharma Dive considers “Cancer patients are living longer than ever. Pain drugmakers haven’t kept up. Decades of slow-moving research, along with broader failures of the healthcare system, have left millions of people in daily pain. Doctors fear that’s bound to continue.”
  • BioPharma Dive also notes,
    • “Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing “strategic business reasons,” according to a federal database. The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lilly’s marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.
    • “In an email to BioPharma Dive, a Lilly spokesperson said company executives “routinely evaluate our clinical development programs to optimize the potential for each product” and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.
    • “Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisk’s Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.”
  • The Washington Post explains why the brain hangs on to some memories but allows others to fade. Tying “fragile” memories to emotional events could help people remember them better in the future, researchers at Boston University believe.”
  • Per a National Institutes of Health news release,
    • “Today, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.
    • “This groundbreaking initiative will transform how we conduct biomedical research through innovative approaches to advancing human-based technologies,” said NIH Director Dr. Jay Bhattacharya. “By creating standardized, reproduceable, and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling, public health protection, and reducing reliance on animal models.”

From the AI front,

  • STAT New reports,
    • “Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential.
    • “A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here.
    • “Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health closed another fiscal year with operations in the red, with the large Catholic nonprofit pointing to expenses growth outpacing revenues “despite strong volume, salary cost management and higher productivity.”
    • “The 138-hospital system reported an as-recorded operating loss of $687 million (-1.8% operating margin) for the fiscal year ended June 30, 2025, as compared to the prior year’s $581 million operating loss (-1.5% operating margin).
    • “However, after adjustments to normalize delayed income from the California Provider Fee Program, CommonSpirit somewhat improved its stature with a $225 million operating loss (-0.6% adjusted operating margin) as opposed to fiscal 2024’s $875 million operating loss (-2.4% adjusted operating margin).
    • “Net income in fiscal 2025 was $1.1 billion as recorded and nearly $1.6 billion as adjusted, both increases over the prior year’s respective $797 million and $503 million.”
  • and
    • “Value-based cancer care navigation company Thyme Care raised $97 million in series D funding backed by major strategic investors across payers, employers, health systems and retail health.
    • “The latest funding propels Thyme Care’s valuation to north of $1 billion, a 2x increase from its valuation in July 2024 when it raised $95 million, according to a company spokesperson.
    • “The company plans to use the new funding to expand its business across verticals and to take on more breaking points in the oncology journey that drive up costs and cause friction in the patient experience, Robin Shah, CEO and co-founder of Thyme Care, told Fierce Healthcare.
    • “Thyme Care is now focused on tackling treatment denials, high drug costs and “the barriers that delay or prevent access to timely, affordable and appropriate care,” Shah said.’
  • and
    • “Medicare Advantage (MA) has been a consistent earnings booster for insurers, but recent challenges in this space are likely to ding profitability, according to a new report.
    • “Analysts at AM Best found that elevated utilization trends beginning in 2023 led to a $5.7 billion underwriting loss in 2024 for MA plans, while insurers reported gains in the previous five years. Underwriting gains in MA accounted for 40% of total gains from 2019 to 2022, but that dropped to 20% in 2023.
    • “The report found that close to three-quarters of companies with a significant concentration in MA reported underwriting losses in 2024.
    • “Medicare Advantage enrollment and premium continue to grow as more people are aging into the program. However, plans have experienced an increase in utilization and medical trends that have persisted longer than expected,” said Jason Hopper, associate director for industry research and analysis at AM Best, in a press release.“
    • “Changes to the risk-adjustment payment model by the Centers for Medicare and Medicaid Services, as well as lower Star Ratings across the industry, also have contributed to recent underwriting losses,” Hopper said.
  • MedTech Dive informs us,
    • “Guardant Health and Quest Diagnostics will collaborate to offer Guardant’s Shield blood-based colorectal cancer test through Quest’s distribution network, the companies said Wednesday.
    • “Physicians will be able to order the test through their Quest accounts and electronic health record starting in the first quarter of 2026.
    • “In an investor day presentation, Guardant Co-CEO AmirAli Talasaz also revealed plans to expand Shield to include multi-cancer detection. The multi-cancer offering will be available nationally in October.”
  • Modern Healthcare reports,
    • “As more upstarts strive to make a splash in the pharmacy benefit manager sector, RxBenefits CEO Robert Gamble thinks his company has devised something truly novel.
    • “Like other companies seeking to disrupt a market dominated by CVS Health subsidiary CVS Caremark, UnitedHealth Group division Optum Rx and Cigna unit Express Scripts, Illuminate Rx promises pharmacy benefits without spread pricing or hidden fees, and with transparency and a focus on generic and biosimilar drugs. The company launched Illuminate Rx this month.
    • “What Gamble said differentiates this offering is that RxBenefits has added an in-house PBM to its marketplace platform, where self-funded employers, brokers and benefits consultants can select among Illuminate Rx and other PBMs for the best deals.”
    • “RxBenefits, which serves 3 million insurance members and manages $3 billion in annual pharmacy spending, named veteran executive Gamble as CEO last December following Wendy Barnes’ departure to become president and chief executive of the pharmaceutical discount vendor GoodRx.”

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
  • Congress is on a District/State work break this week.
  • Govexec tells us,
    • “Newly elected Rep. James Walkinshaw, D-Va., this week formally took over for his predecessor, the late Rep. Gerry Connolly, in leading advocacy for an array of bills aimed at improving the pay and civil service protections of federal workers.” * * *
    • “The House on Tuesday granted Walkinshaw’s unanimous consent request to become lead sponsor for four bills that Connolly had previously introduced, all relating to federal personnel policy.”
  • Plan Sponsor lets us know,
    • “The Senate confirmed Daniel Aronowitz as assistant secretary of labor for the Employee Benefits Security Administration on Thursday.
    • “EBSA is responsible for enforcement of the Employee Retirement Income Security Act and related laws and regulations, along with protecting employer-based retirement, health and welfare benefits for workers and retirees.
    • “During his June 5 confirmation hearing, the former president of Encore Fiduciary pledged to streamline retirement plan oversight and end the ‘war’ on employee stock ownership plans, also known as ESOPs.”
  • OPM typically announces the next year’s FEHB / PSHB government contributions in the second half of September. OPM shares this information with Congress before making the announcement which suggests that the announcement will be made next week when Congress returns to Capitol Hill.
  • Nextgov/FCW points out,
    • “The Office of Personnel Management is rolling out ChatGPT to its employees this week, its director told employees Tuesday. 
    • “This is part of our broader effort to equip you with AI tools that help you work faster, think bigger, and collaborate better,” the agency’s director, Scott Kupor, told staff in an email shared with Nextgov/FCW by the agency. 
    • “Employees already can access Microsoft 365 Copilot chat, the email says, but now they’ll have access to OpenAI’s ChatGPT-5, too. 
    • “AI is a great assistant, but you’re still the expert. I know some of you are excited, some are curious, and some are wary. In the coming weeks, [the Office of the Chief Information Officer] will host brown bag sessions to help clarify and ensure you get the most out of these tools,” the email reads. “Let’s lead the way in using AI thoughtfully and effectively — starting now.”

From the ACIP recommendations front,

  • The Pharmacy Times article offers more details about the Covid vaccination decisions made at the ACIP meetings last week. 
    • “The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation. 
    • “They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
    • “Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote’s failure.
  • The Covid vaccine is not the first time that ACIP recommended shared decision making. The ACIP website includes an FAQ on shared decision making. A pharmacist is a healthcare provider for purposes of shared decision making. 
  • From a maintaining the status quo standpoint, it’s very important that ACIP rejected a recommendation to require a prescription for Covid vaccines. 
  • The New York Times reports yesterday,
    • Before the C.D.C. panel voted, CVS and Walgreens, the nation’s two largest pharmacy chains, were requiring prescriptions in some states because of laws forbidding pharmacists to administer vaccines in the absence of a recommendation from the panel.
    • But if the head of the C.D.C. adopts the panel’s recommendations, CVS will start providing the shots without prescriptions nationwide, including to people outside the F.D.A.-approved groups, according to a CVS spokeswoman, Amy Thibault.
    • Walgreens did not immediately confirm what it would do.
  • ACIP’s website explains
    • “The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States.
    • “These recommendations become official CDC policy once adopted by CDC’s Director.
    • “This page provides resources related to ACIP recommendations and lists recommendations from ACIP meetings that are pending publication in CDC’s Morbidity and Mortality Weekly Report (MMWR).”
  • An HHS news release on Friday states,
    • “I commend the committee for bringing overdue scientific debate on vaccination to the American people,” said Deputy Secretary of Health and Human Services and CDC Acting Director Jim O’Neill. A recommendation from ACIP becomes part of the CDC immunization schedule if it is adopted by the CDC director.”
  • The CDC director typically adopts ACIP recommendations promptly. The FEHBlog will keep an eye out.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The FDA, under President Trump’s directive, is cracking down on direct-to-consumer pharmaceutical ads.
    • “The FDA sent letters to drugmakers citing issues with ads that potentially violate drug-marketing laws.
    • “The FDA is scrutinizing ads that it says overhype drug effectiveness, not just those omitting side effects, marking a shift in enforcement.”
  • The Washington Post informs us,
    • “The Trump administration is expected to unveil new efforts on Monday exploring how one medication may be linked to autism and another one can treat it, according to four people with knowledge of the plans who spoke on the condition of anonymity because the announcement was not yet public.
    • “Federal health officials are expected to raise concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol and one of the most widely used medications globally. Officials have been reviewing previous research — including an August review by Mount Sinai and Harvard researchers — that suggests a possible link between Tylenol use early on in pregnancy and an increased risk of autism in children. They plan to warn pregnant women against using Tylenol early on unless they have a fever, according to the four individuals.
    • “In addition, officials plan to tout a lesser-known drug called leucovorin as a potential autism treatment. Leucovorin is typically prescribed to counteract some medications’ side effects and to treat vitamin B9 deficiency. Early double-blind, placebo-controlled trials administering leucovorin to children with autism have shown what some scientists describe as remarkable improvements in their ability to speak and understand others. Officials at the Food and Drug Administration have recently been reviewing new language that could apply to the drug.”

From the public health front,

  • Per Medscape,
    • “Use of GLP-1 receptor agonists (GLP-1s) was associated with a reduction in fragility fractures among older women with type 2 diabetes (T2D) in a retrospective analysis of data from a global health network. The results suggest that GLP-1 therapy could contribute to bone health.”
  • Medscape also identifies benefits and risks to watch out for when older adults take GLP-1 drugs.
    • “In adults over 65, GLP-1 use has both potential benefits and risks for age-related health. Physicians should stay alert, monitor closely, and address side effects proactively.’
  • NPR notes,
    • “Doctors who perform skin cancer surgeries often recommend nicotinamide — which is a form of Vitamin B3 — to their patients. It’s been shown to protect cells from UV radiation damage.
    • “Now, a new study of nearly 34,000 veterans, finds this over-the-counter supplement is linked to a reduction in non-melanoma skin cancers among people who’ve already had skin cancer. The research was published in JAMA Dermatology.
    • “The biggest reduction was seen among people who began taking the supplement after being diagnosed with their first skin cancer. Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk of developing another skin cancer, compared to patients who did not take the supplement.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx 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 activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.