Tuesday Tidbits

Obesity

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec let us know,
    • “The top House Republicans for veterans’ issues are pushing a new measure to codify and expand privatized health care on the taxpayer dime, reigniting a controversial issue that is likely to come back to the fore under President-elect Trump. 
    • “The Complete the Mission Act would serve as a followup to the 2018 Mission Act that Trump signed into law, which streamlined and expanded veterans’ access to private sector care paid for by the Veterans Affairs Department. Congress passed the Mission Act on a bipartisan basis to follow a 2014 law with similar goals, but lawmakers have since disagreed over its implementation. 
    • “The new bill, introduced by House Veterans Affairs Committee Chairman Mike Bost, R-Ill., would ensure existing access standards for private sector “community care” are codified in law. Those rules allow veterans living more than a 30-minute drive on average from the nearest VA facility to access the community care network for services such as primary care, mental health and some extended care. For specialized care, veterans must live more than a one-hour drive from the nearest VA facility. They can also access private care when a close VA facility does not provide the service they are seeking, or when their VA doctor recommends it. 
    • “Bost’s measure would expand extended care options in the private sector and bar VA from considering telehealth availability when calculating community care eligibility. It would also require VA to consider veterans’ preference of where to seek treatment. The bill would create a three-year pilot in which patients could enroll in non-VA outpatient mental health or substance use treatment without requiring.”
  • Federal News Network informs us,
    • “Agency leaders in charge of combatting fraud are highlighting the importance of workforce training and data sharing, as the White House touts a deep decline in the governmentwide rate of improper payments.
    • “The Office of Management and Budget last week reported the governmentwide rate improper payment rate had fallen to 3.97%, the lowest since 2014. The rate has dropped by nearly 50% since fiscal 2021, when improper payments and fraud soared amid emergency COVID relief spending.
    • “The total amount of improper and unknown payments in fiscal 2024 was $161.5 billion, compared to just under $236 billion in fiscal 2023, according to data posted on PaymentAccuracy.gov.
    • “The White House said the past year’s progress was driven by “a government-wide approach focused on improving up-front controls, prioritizing fraud prevention, and driving increased collaboration between agencies and their inspectors general.”
  • The Internal Revenue Service announced that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2024, and before October 1, 2025, is $3.47.
  • The Office of Personnel Management’s Inspector General released her latest semi-annual report to Congress.
  • Adam Fein, writing in his Drug Channels blog, shares four revelations about Minnesota’s first 340B program transparency report.

From the public health and medical research front,

  • STAT News reports,
    • “At the annual meeting of the Menopause Society earlier this fall, researchers presented new evidence that hormone therapy can be beneficial to menopausal women’s heart health, reducing insulin resistance and other cardiovascular biomarkers. It was the latest in a long line of research showing the benefits of hormone therapy for women in menopause, which also includes alleviating symptoms like hot flashes, sleep disturbances, vaginal dryness, and pain during sex.
    • “But despite this evidence, hormone therapy’s use has plummeted over the past few decades. In 1999, almost 27% of menopausal women in the U.S. used estrogen. By 2020, less than 5% did. 
    • “So why aren’t more women in menopause taking advantage of treatments known to be effective? Misconceptions about the risks of hormone therapy are one reason, according to experts. So is the lingering cultural taboo around discussing menopause, which has created “a perfect storm for under-treatment,” said Theodoros Kapetanakis, an OB-GYN at Mount Auburn Hospital’s Endometriosis Center in Waltham, Mass.” 
  • Healio tells us.
    • “The beneficial impact of physical activity on mortality risk remained consistent across the adult lifespan, even growing stronger later in life, according to study results published in JAMA Open Network.
    • “In contrast, other modifiable health factors saw their effects on the risk for mortality decrease with increasing age.
  • RAND offers a report titled “Improving the Detection of Cognitive Impairment and the Pathway to Treatment.”‘
    • “Low cognitive ability, functional limitations, and poor physical health are strong predictors of dementia as many as 20 years before its onset. Lifestyle factors, such as never drinking alcohol or drinking excessively, never exercising, and low engagement in hobbies, are associated with cognitive impairment and dementia.
    • “Early detection of cognitive impairment helps people take mitigating actions to prepare for future loss of their financial and physical independence.
    • “Older adults’ take-up of cognitive testing is low, and many who do get tested exit the clinical care pathway before being diagnosed and receiving treatment. Take-up of cognitive tests would increase if tests were free and readily accessible. Treatments would be more palatable if they had fewer side effects and helped patients maintain independence longer.
    • “More engagement of primary care practitioners and team-based care in the clinical care pathway and the use of new technologies, such as blood-based biomarkers, could ease health care system capacity constraints on dementia specialists and reduce wait times for patients.”
  • McKinsey & Company offers ideas about “How to address healthcare inequities for people with disabilities.”
    • “Globally, people with disabilities have a mortality rate that is 2.24 times higher than those without disabilities. And although people with disabilities often have greater healthcare needs, they also experience more and higher barriers to care. McKinsey’s Dr. Mona Hammami and coauthors write that in the patient care pathway, people with disabilities are more likely to report:
      • “skipping or delaying care because of cost
      • “having difficulty securing transportation to a health facility
      • “encountering inaccessible facilities
      • “meeting workers with inadequate skills or flexibility to provide quality care
    • “This International Day of Persons with Disabilities (IDPD), examine inequities in the patient care pathway, potential interventions to overcome them, and a three-step approach to reducing inequities across communicable and non-communicable disease types.”
  • The New York Times reports
    • “Health officials have closed their investigations into an E. coli outbreak linked to raw onions on McDonald’s Quarter Pounder hamburgers that sickened more than a hundred people, the Food and Drug Administration (FDA) announced Tuesday.
    • “In total, 104 people from 14 states were sickened from the contaminated food and 34 were hospitalized. One older person in Colorado died.
    • “Officials said there did not appear to be a “continued food safety concern,” because McDonald’s had not served slivered onions — which investigators determined to be the “likely source of contamination”— on the Quarter Pounders for more than a month. The onions were recalled. And in many states, Quarter Pounders were removed from the menu altogether for several weeks.
    • “There have not been any new illnesses since McDonald’s decided to remove the onions from its menu on Oct. 22, according to the Centers for Disease Control and Prevention.”
  • Per an FDA announcement,
    • “On Monday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. As of November 26, 2024, a total of 68 people infected with the outbreak strain of Salmonella have been reported from 19 states. Of the 50 people for whom information is available, 18 have been hospitalized. No deaths have been reported. Of the 33 people interviewed, 27 (82%) reported eating cucumbers.
    • “On November 27, 2024, SunFed Produce, LLC initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. in Sonora, Mexico. On November 29, 2024, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. On December 1, 2024, Russ Davis Wholesale initiated a voluntary recall of American/slicer cucumbers and multiple products containing recalled cucumbers.
    • “The FDA is working with the recalling firms and their direct customers to determine if additional downstream customer recalls are necessary. The FDA’s investigation is ongoing.”

From the U.S. healthcare business front,

  • Modern Healthcare relates,
    • “Kaiser Permanente-backed Risant Health acquired Cone Health on Sunday, making it the second health system to join Risant in less than a year.
    • “Cone is following in the footsteps of Geisinger Health, which was folded into the newly-formed Risant in March. Kaiser created Washington, D.C.-based Risant earlier this year as a nonprofit entity to buy systems and form a national network for value-based care.” * * *
    • “Having two of these close in one year has made for a pretty busy year,” said Dr. Jaewon Ryu, CEO at Risant. “It’s great to get on the other side of the regulatory approvals and finalize welcoming [Cone] into Risant Health.”
  • Beckers Hospital Review notes,
    • “California was CommonSpirit’s top-performing market in terms of margins in the first quarter of fiscal year 2025 (the three months ending Sept. 30) but the Chicago-based system’s South region, which includes Texas and Kentucky, “remains challenged,” Benjie Loanzon, senior vice president and corporate controller, said during the company’s Dec. 2 earnings call. 
    • “We are taking a range of actions in this region, focusing on our ambulatory strategy,” Mr. Loanzon said. “We are encouraged by recent performance improvements, though a significant amount of work will be needed to reach an acceptable level [of] performance.”
    • “CFO Dan Morissette said the health system continues to look at ways to improve the South region’s performance. Key focus areas include contracting, efficiency, growth and cost containment. 
    • “Although Texas didn’t perform well in Q1, we are encouraged by other achievements in terms of the volume and cost containment,” Mr. Loanzon said. “Kentucky is the most improved market in terms of the financial performance. In terms of the volume and cost containment, it has a positive EBIDTA compared to the past.”
  • Per BioPharma Dive,
    • “Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. 
    • “The findings come from an early-stage study testing the biotechnology company’s therapy, dubbed JANX007, in 16 people with a form of advanced prostate cancer. Data Janux first disclosed earlier this year vaulted the company’s market value past $2 billion. While early and from a small clinical trial, the new results announced Monday afternoon pushed Janux’s shares nearly 75% higher, changing hands Tuesday morning at more than $70 apiece.”‘
  • Beckers Payer Issues tells us how much health plans are paying for GLP-1 drugs.
    • The prices for some GLP-1s have dropped significantly in recent years for individuals covered by Medicare and commercial insurance, according to a new report from HHS,
    • In 2024, the U.S. list prices for a one-month supply for most GLP-1s are stable or increasing, but after payer negotiations and rebates, net prices for many GLP-1s have decreased since 2022. Net prices for GLP-1s are between 24% and 73% lower than list prices, indicating that most insurers are paying less than the manufacturer’s list price.
    • “In the net prices, we see evidence of the impact of competition as new drugs in the class enter the market,” HHS wrote. “While list prices are consistently stable or increasing, for many of these drugs, including Ozempic, Rybelsus, Saxenda, and Victoza, net prices fell.”
  • Healthcare Dive explains “Healthcare organizations must carefully vet AI tools, address patient concerns and keep an eye on standards and regulation, according to industry experts who spoke at a Healthcare Dive virtual event.”

Monday Roundup

David Ermer–CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • CMS issued a World AIDS HIV Day Fact Sheet today.
    • “Approximately 1.2 million people in the United States are living with HIV, which disproportionately affects men and underserved communities. While it was once a deadly diagnosis, HIV is now a health condition that people can manage through their lifetimes with access to safe, appropriate, high-quality treatment and support services. Thanks to the advancement of science, U=U, or undetectable equals untransmittable, means that people with HIV with an undetectable viral load cannot sexually transmit the virus to others, transforming lives and reducing stigma.
    • “The Centers for Medicare & Medicaid Services (CMS) is proud to celebrate World AIDS Day 2024 with the theme “Collective Action: Sustain and Accelerate HIV Progress” through our continuous focus to provide affordable, accessible, high-quality care to all individuals enrolled in our programs, including people with HIV/AIDS. CMS is helping to drive progress across each of its strategic pillars and its commitment to advance equity, expand access, engage partners, drive innovation, protect programs, and foster excellence.”
  • Per a House of Representatives press release,
    • “Today, the Select Subcommittee on the Coronavirus Pandemic concluded its two-year investigation into the COVID-19 pandemic and released a final report titled “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward.” * * *
    • “On Wednesday, December 4, 2024, at 10:30am, the Select Subcommittee will hold a markup of the final report and officially submit the report to the Congressional record. Ahead of the markup, the Select Subcommittee will also release additional supporting materials and recommendations.
    • “The full, 520-page final report can be found here.”
    • The Committee’s summary of the final report can be found in the press release.
  • My Federal Retirement discusses the health reimbursement account tools found in consumer driven FEHB and PSHB plans.
  • Modern Healthcare reports,
    • “UnitedHealthcare and Centene have received higher Medicare Advantage star ratings for the 2025 plan year after the Centers for Medicare and Medicaid Services revised their scores.
    • “On Monday, CMS published updated Medicare Advantage Star Ratings program data that reveal the agency increased the quality ratings for 12 UnitedHealthcare contracts and seven Centene contracts, each of which comprise multiple Medicare Advantage plans. CMS issued 2025-star ratings for all Medicare Advantage insurers in October.” * * *
    • “Centene gained its sole four-star contract under the recalculations CMS disclosed Monday. Two UnitedHealthcare contracts were upgraded to five stars and three to four stars, giving the UnitedHealth Group subsidiary 37 contracts rated at least four stars.
    • “The U.S. District Court for the Eastern District of Texas ordered CMS to redo UnitedHealthcare’s scores last month in a case involving how the agency evaluated the company’s call center services. Centene initiated a similar lawsuit in October, which is still on the docket, as is a complaint from Humana. Elevance Health and Blue Cross and Blue Shield of Louisiana sued over their scores on different grounds.”

From the public health and medical research fronts,

  • STAT News explores “Why have U.S. bird flu cases been so mild?” Here are the hypotheses considered in the article:
    • “Hypothesis: The way in which the virus is being transmitted — along with the amount of virus exposure — is limiting the severity of disease
    • “Hypothesis: The version of H5N1 circulating in the U.S., the 2.3.4.4b clade, is inherently less dangerous to people.”
    • “Hypothesis: People are less susceptible to severe infection from H5N1 than we used to be.”
    • “Hypothesis: Public health officials were previously unaware of a significant number of mild H5N1 cases in humans, leading to a dramatic overestimation of H5’s feared case fatality rate. Only now are we getting a true picture of the spectrum of infection.”
  • Per BioPharma Dive,
    • “The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound.
    • “The group on Monday released an official guidance statement that recommends doctors avoid prescribing unapproved, off-brand versions of the medicines, which have been so in demand their manufacturers, Novo Nordisk and Eli Lilly, have had difficulty keeping up supply.
    • “We urge health care professionals to consider this guidance statement due to concerns around the safety, quality, and effectiveness of compounded versions of these products,” said Joshua Neumiller, the ADA’s president-elect and a co-author of the statement.”
  • The New York Times proposes five questions to ask your doctor when deciding whether to undergo a hysterectomy.
  • Medscape tells us,
    • “Novocure said on Monday its experimental therapy extended the lives of patients with a form of advanced pancreatic cancer when combined with chemotherapy, achieving the primary goal in a late-stage trial.
    • “The therapy uses Tumor Treating Fields, or electric fields, to kill cancer cells while sparing most nearby healthy cells, using a portable device placed on the skin near the tumor.
    • ‘In the study, TTFields therapy concomitant with chemotherapy helped patients live for an average of 16.20 months, compared to 14.16 months in patients treated with chemotherapy alone, Novocure said.
    • ‘The treatment’s safety was consistent with prior clinical studies, the company said.
    • “The therapy also helped improve survival rates over time, according to Novocure. The rate of overall survival, or the length of time a patient lives from the start of treatment, improved by 13% at 12 months and by 33% at 24 months, the company said.”
  • and
    • “Individuals with normal body mass index (BMI) measurements may still face an increased risk for colorectal cancer (CRC) if they have central obesity, characterized by excess fat around the abdomen.”
  • Consumer Reports, writing in the Washington Post, points out “tools to help you remember when to take pills. Poor medication adherence results in an estimated 125,000 deaths each year.

From the U.S. healthcare business front,

  • Fierce Healthcare honors ten women of influence in healthcare. Kudos to them.
  • Modern Healthcare reports,
    • “GE HealthCare will take on full ownership of the drug company Nihon Medi-Physics in a transaction with Sumitomo Chemical that is expected to close in early 2025, the company announced Monday.
    • “Nihon Medi-Physics’ portfolio includes radiopharmaceuticals for neurology, cardiology and oncology that are used in clinical imaging to help diagnose Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies and coronary artery disease. The GE HealthCare-Sumitomo Chemical is subject to regulatory review and the companies did not disclose the terms of the deal.
    • “GE HealthCare has owned half of Nihon Medi-Physics since 2004, when former parent company General Electric obtained the stake as part of its acquisition of drugmaker Amersham.”
  • and
    • “Community Health Systems’ Northwest Healthcare acquired 10 urgent care centers in Arizona from Carbon Health.
    • “The transaction grows Northwest’s network across the Tucson, Arizona, area to more than 80 care sites, according to a Monday news release. One of the 10 centers was not in operation when the deal closed and is awaiting a certificate of occupancy from the state of Arizona, a CHS spokesperson said.
    • “Financial details of the deal were not disclosed.”
  • Beckers Hospital Review informs us,
    • “Pittsburgh-based UPMC reported an operating loss of $57.6 million (-0.7% margin) in the third quarter ended Sept. 30, 2024, up from a $191 million operating loss (-2.8% margin) reported during the same time period in 2023, according to the system’s most recent financial report.”
  •  and
    • “Despite an end to the recent IV fluid shortage being in sight, hospital administrators may continue to adjust standard practices, KFF Health News reported Nov. 27.”  * * *
    • “Falls Church, Va.-based Inova Health System’s chief of research stewardship, Sam Elgawly, MD, told KFF Health News that the system has dropped its IV fluid usage by 55% since early October.
    • “There has been increasing literature over the last 10 to 20 years that indicates maybe you don’t need to use as much,” Dr Elgawly told KFF Health News. “[The shortage] accelerated our sort of innovation and testing of that idea.”
    • “Read the full KFF Health News report here.”
  • Per BioPharma Dive,
    • “Novartis could pay close to $3 billion for brain drugs developed by PTC Therapeutics, per a deal announced Monday.
    • “At the center of the deal is an experimental medicine, PTC518, which is currently being tested as a potential treatment for Huntington’s disease in a roughly 250-person clinical trial. The main portion of that study should complete early next year. But ahead of those results, PTC has entered into an exclusive licensing agreement that gives Novartis rights to the medicine as well as related molecules.
    • “The deal is set to close before the end of March, according to the companies. If it does, PTC will get $1 billion upfront. The New Jersey-based drugmaker could receive milestone payments worth up to $1.9 billion, in addition to royalties on any PTC518 sales outside the U.S.”
  • and
    • “Swiss pharmaceutical giant Roche is spending around $1 billion to acquire a San Diego-based biotechnology company that’s trying to treat certain cancers and rare diseases with a slate of cell therapies and genetic medicines.
    • “The deal, announced Tuesday, has Roche paying $9 per share of Poseida Therapeutics. Poseida investors may additionally receive as much as $4 per share more via a so-called contingent value right if the biotech’s drug programs hit specific research and commercial milestones. The acquisition is expected to close sometime between January and the end of March.
    • “The two companies were already working together through a licensing agreement inked in 2022. Terms of the new deal suggest Roche sees even more promise in Poseida’s gene editing technologies, which are being used to create allogeneic, or “off-the-shelf,” cell therapies that don’t rely on a patient’s own donor cells. Roche’s offer is 215% above Poseida’s closing share price on Monday — representing one of the largest premiums paid in a big-ticket biopharma acquisition over the past several years.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The deadline for Congress to take action on Fiscal Year 2025 appropriations is Friday December 20.
  • FedWeek lets us know,
    • “Rep. James Comer, R-Ky., is due to remain chairman of the Oversight and Accountability Committee for the 2025-2026 Congress.” * * *
    • “On the Senate side, another Kentucky Republican, Sen. Rand Paul, is set to become chairman of the Homeland Security and Governmental Affairs when the GOP takes control of that chamber.” * * *
    • “There has been no indication of a nominee for OPM director, but one potential candidate would be Michael Rigas, who was deputy director late in the first term and then acting director from March 2020 when the second of the directors confirmed in that administration resigned after disputes over the White House’s intent to move OPM’s policy functions directly under OMB. Rigas was not then nominated to become director, however.”
  • The Medicare open enrollment period ends this Saturday December 7, while the Federal Employees Benefits Open Season is scheduled to end the following Monday, December 9. It remains to be seen whether OPM will extend the first open season for the Postal Service Health Benefits Program as some have urged.
  • The FEHBlog urges OPM and PSHBP carriers to share with Postal Service annuitants over age 65 the substance of this Washington Post article about “How to take advantage of Medicare’s expanded drug benefit in 2025. “It will be easier to spread out Part D drug costs over the year, while the total annual cost of medicines will be capped at $2,000.” The new Medicare Part D features make Part D a viable alternative to folks who currently rely on manufacturer coupons.
  • The U.S. Attorney’s Office for the Southern District of Texas announced last Wednesday,
    • “A 53-year-old Sugar Land [Texas] man has agreed to pay $2,095,946 to resolve allegations he submitted false claims for the placement of electro-acupuncture devices, announced U.S. Attorney Alamdar S. Hamdani.
    • “Dr. Rajesh Bindal used the entity Texas Spine & Neurosurgery Center P.A. to conduct his medical practice. From March 16, 2021, to April 22, 2022, Bindal billed Medicare and the Federal Employees Health Benefits Program (FEHBP) for the surgical implantation of neurostimulator electrodes. 
    • “These are invasive procedures usually requiring use of an operating room. As a result, Medicare and the FEHBP pay thousands of dollars per procedure. 
    • “However, neither Bindal nor his staff performed these surgical procedures, according to the allegations. 
    • “Instead, patients allegedly received devices used for electro-acupuncture, which only involved inserting monofilament wire a few millimeters into patients’ ears and taping the device behind the ear with an adhesive. In some instances, a device sales representative or a physician assistant allegedly performed these placements, which were then billed as surgeries. All device placements took place in Bindal’s clinic, not a hospital or surgical center, and no incision was made on a patient. Most patients claimed the adhesive came loose and the device fell off on its own accord within a few days.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Many of the manufacturing jobs that are being moved overseas, replaced by automation or phased out of the American economy were mostly filled by men. As a result, other occupations traditionally dominated by women are now gaining a larger share of men, including elementary and middle-school teachers and customer-service representatives. 
    • “Still, nursing is a relative outperformer in the proportion of men joining what has long been considered a “pink collar” sector. The number of male registered nurses has increased from about 140,000 in 2000 to about 400,000 in 2023. This means that about 14% of nurses are now men, up from about 9% roughly two decades ago. 
    • “Economists at the Washington Center for Equitable Growth found that men who were becoming registered nurses tended to do so in their late 20s or early 30s rather than as their first job.”
  • and
    • “The obesity duopoly has been pierced as Amgen positions itself to have a drug on the market in a few years. While this adds competition to a market currently controlled by Eli Lilly and Novo Nordisk, it also reinforces the dominance of the makers of Wegovy and Zepbound.
    • “Amgen reported on Tuesday that its highly anticipated obesity-drug candidate, MariTide, helped patients shed around 20% of their body weight, though side effects such as nausea and vomiting were common. The company didn’t disclose detailed data, which is expected at a medical conference next year. If all goes well in a larger late-stage study, Amgen could have a drug on the market within a few years. 
    • “But what we already know suggests that Lilly and Novo Nordisk’s market leadership isn’t about to be upended. Not only did MariTide fail to outperform Lilly’s Zepbound, but both Lilly and Novo also have next-generation medications under development, with promising data showing even more impressive weight loss results.”
  • HR Dive tells us
    • “What employers should know now that the 2024 [Fair Labor Standards Act] overtime rule is vacated.
    • “One attorney cautioned against dropping workers’ recently changed nonexempt status too quickly or without careful consideration.”

Happy Thanksgiving!

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–

The FEHBlog will be back on Friday.

From Washington, DC,

Transition News

  • Govexec tells us,
    • “President-elect Trump has reached an agreement with the Biden administration that will allow his teams to deploy throughout federal government, ending a standoff that had blocked official presidential transition efforts taking place. 
    • “Transition staff assigned to each agency, known as landing teams or agency review teams, will now physically enter headquarters offices throughout government. Once there, they will meet with assigned career senior executive staff, receive already drafted briefings on agency activities and begin the process of exchanging information about existing projects and future priorities.”
  • STAT News reports,
    • “President-elect Trump has chosen Stanford University professor Jay Bhattacharya to lead the National Institutes of Health, his transition announced Tuesday.
    • “If confirmed by the Senate, Bhattacharya would be in charge of implementing the incoming Trump administration’s bold goals to reform the agency. 
  • The Wall Street Journal adds,
    • “Bhattacharya is both a doctor and economist who became known during the Covid-19 pandemic as a co-author of the Great Barrington Declaration, a document that called for ending lockdowns and isolating the vulnerable so that young, healthy people could get infected and build up immunity in the population. 
    • “Other doctors and public-health researchers, including then-infectious disease chief Dr. Anthony Fauci, criticized the document and said its approach was flawed and would lead to unnecessary deaths.”
  • The Hill notes,
    • “President-elect Trump’s choice for deputy secretary of Health and Human Services is Jim O’Neill, an investor and historically close associate of billionaire Peter Thiel, the president-elect said Tuesday.”

Medicare / GLP-1 Drug News

  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services Nov. 26 issued a final rule that expands access to kidney and liver transplants for individuals with HIV by removing clinical research requirements. Specifically, the rule implements a stipulation under the HIV Organ Policy Equity Act, eliminating the need for approval from the clinical research and institutional review board for kidney and liver transplants between donors with HIV and recipients with HIV. The change was based on research showing the safety and effectiveness of such transplants, HHS said. The final rule is effective Nov. 27.
    • “In tandem with the final rule, the National Institutes of Health published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung and pancreas, with a 15-day comment period.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 26 proposed changes to the Medicare Advantage and prescription drug programs for contract year 2026. Those changes would permit coverage of anti-obesity medications in the Medicare and Medicaid programs; fortify existing limitations on insurer use of internal coverage criteria and requirements for MA plans to provide coverage for all reasonable and necessary Medicare Part A and B benefits; and apply additional guardrails to insurer use of artificial intelligence to ensure it does not result in inequitable treatment or access to care. CMS also proposes to update MA and Part D plan medical loss ratio reporting requirements to improve oversight, align reporting with commercial and Medicaid reporting, and request additional information on MLR and vertical integration. 
    • “Among other provisions, the proposed rule would require MA plans to make provider directory information more widely available through the Medicare Plan Finder tool; limit enrollee cost sharing for behavioral health services to an amount that is no greater than Traditional Medicare; enhance CMS oversight of MA agent and broker marketing and communication materials; increase insurer reporting requirements related to insurer use of prior authorization and potential health equity implications; and add new requirements governing MA plan use of debit cards to administer enrollee supplemental benefits. Finally, the proposed rule would also codify several provisions in the Inflation Reduction Act, such as capping certain out-of-pocket costs in Medicare Part D, and other pharmacy-related provisions, such as new requirements for Part D sponsors on formulary inclusion and placement of generic drugs and biosimilars.” 
  • Here is a link to the CMS fact sheet about the Medicare Advantage and Part D proposed changes for 2026.
  • KFF already has issued a policy watch about CMS’s proposal to cover GLP-1 drugs for obesity under Medicare Part D and Medicaid beginning in 2026. The FEHBlog is surprised that CMS made this decision knowing that the Inflation Reduction Act has placed financial pressure on standalone Medicare Part D plans.
  • The Wall Street Journal notes,
    • The [GLP-1 drug] proposal, which would have to be finalized by the Trump administration, faces uncertain prospects.
  • In this regard, Beckers Hospital Review shares the recent comments of President-elect Trump’s nominee for HHS Secretary Robert F. Kennedy, Jr., concerning GLP-1 drugs.
  • The Wall Street Journal adds,
    • “Meantime, Mehmet Oz, the choice to run the Centers for Medicare and Medicaid Services, has said on X that the drugs “can be a big help. We need to make it as easy as possible for people to meet their health goals, period.” * * *
  • On a related note, MedCity News discusses “The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care.”

Federal Employment Tidbits

  • Federal News Network reports
    • “Federal Executive Boards are looking to expand their offerings to even more federal employees working outside of the Washington, D.C., region.
    • “After reporting successful training sessions, recruitment events and cost savings in the last fiscal year, the Office of Personnel Management sees an opportunity to extend FEBs’ reach to more than double the number of feds who can access the program’s resources.
    • “The expansion would now be possible, after the FEB program went a restructuring, as well as recently developing a new funding model, OPM said.
    • “This transformation is designed to enhance the FEBs’ effectiveness in fostering interagency collaboration, better serve the 85% of federal employees located outside Washington, D.C., and expand FEBs’ reach to areas with significant federal activity but no FEB presence,” OPM wrote in its fiscal 2023 FEB annual report, published earlier this month.”
  • FedWeek lets us know,
    • “Availability of telework has had a positive impact on recruitment and retention, a sampling of four agencies told GAO, but its effect on customer service and other agency operations is hard to gauge—and three of the four have done little to even try.
    • “The effect on productivity has become a major focus in the ongoing debate over agency telework levels that, although well below the peak of the pandemic period, remain high by historic measures. The GAO report, while not conclusive, adds information to a debate that may result in moves to restrict telework starting in January by the new Congress, the Trump administration, or both.”

FDA News

  • Per Fierce Pharma,
    • “In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills, Time exclaimed: “These are the bullets.”
    • “Twenty-three years later, patients no longer need to take a “bullet” to reap the benefits of imatinib as Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of the treatment. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib, Shorla said in a press release.
    • “The therapy can help patients combat myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), gastrointestinal tumors (GIST) and cancers such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).”
  • Per MedTech Dive,
    • “Zimmer Biomet said Monday that it received approval for a cementless partial knee replacement implant in the U.S.
    • “The Oxford Cementless Partial Knee launched in England in 2004. The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S. The orthopedic company plans to launch the implant in the first quarter of 2025.
    • “Zimmer has identified the device as a good fit for ambulatory surgical centers (ASC) and CEO Ivan Tornos has forecast the product will be one of the top three knee growth drivers in the U.S.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A highly anticipated obesity-drug candidate from biotech Amgen helped patients shed a significant amount of weight in a mid-stage study but fell short of the loftier expectations of some investors. 
    • “Subjects taking Amgen’s MariTide lost 20% of their body weight compared with those who received placebos, Amgen said Tuesday. Analysts had generally expected the drug to achieve weight reduction of 20% or more.
    • “About 11% of subjects dropped out of the study because of side effects, the most common of which included nausea and vomiting.”
  • BioPharma Dive offers a tracker for obesity drug trials.
  • Beckers Hospital Review relates,
    • “A new study on asthma medication Singulair has raised concerns about its potential mental health side effects, USA Today reported Nov. 24. 
    • “The study, presented by the FDA at the American College of Toxicology meeting in Austin, Texas, found that the drug binds to multiple brain receptors linked to mood, cognition, sleep and impulse control. While the research does not confirm if this binding causes harmful side effects, experts warned it could be a significant concern. 
    • “Singulair, commonly prescribed for asthma and allergy symptoms, has been linked to severe neuropsychiatric issues, including anxiety, depression, hallucinations, irritability and suicidal thoughts, USA Today reported.
    • ‘In 2020, the FDA added a boxed warning to the drug, highlighting the risk of severe mental health side effects. Since its introduction in 1998, Singulair has been associated with dozens of suicides and other psychiatric disorders, with reports of adverse effects continuing into recent years. 
    • “Despite the new findings, the FDA said it will not immediately update the drug’s label. The agency also emphasized that more research is needed to fully understand the extent of the drug’s impact on the brain, according to the report.”
  • The National Institutes of Health shares news about “Sleep and heart healing | Liver-brain communication | Characterizing sensory nerves.”
  • Beckers Hospital Review offers a “‘straight-A’ hospital’s safety playbook.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Pittsburgh-based health insurer and provider Highmark Health has brought in $529 million in net income through the first three quarters of the year, according to its latest financial details released Tuesday.
    • “That’s on $22.1 billion in revenue through the first nine months of 2024, along with $273 million in operating gain.
    • “Highmark said that its financial performance is driven by its health plans along with increased volumes at its Allegheny Health Network (AHN). As of Sept. 30, the AHN saw a 3% increase in inpatient discharges and observations as well as 7% more outpatient registrations compared to the same time last year.
    • “In addition, the AHN logged a 5% increase in physician visits and a 6% increase in visits to the emergency room.”
  • Modern Healthcare reports,
    • “Community Health Systems scrapped a $120 million deal to sell three Pennsylvania hospitals and related facilities to WoodBridge Healthcare.
    • “CHS and WoodBridge mutually decided to dissolve the agreement Friday due to WoodBridge’s inability to satisfy funding requirements, according to a Tuesday news release. Investment banking firm Zeigler was unable to sell the bonds needed to fund the acquisition, despite earlier indications of confidence in the bond sales, WoodBridge said in a separate release.”
  • Chief Healthcare Executive (11/22, Southwick) reported, “The majority of hospital and health care facility reviews on Yelp are negative, according to a new study.” Investigators found that “in March 2020, 54.3% of reviews on Yelp were positive, but that number has dropped to 47.9%” Chief Healthcare Executive adds, “Since the second half of 2021, positive reviews haven’t surpassed 50%.” The research was published in JAMA Network Open. Thanks, Covid.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “In a flurry of Friday night announcements, President-elect Donald Trump said he had selected Scott Bessent, a financier who embraced MAGA, to head the Treasury Department; Russell Vought, a Project 2025 contributor, to run the White House budget office again; and Rep. Lori Chavez-DeRemer (R-Oregon) [who lost her bid for re-election] for labor secretary. The president-elect also said he had selected Janette Nesheiwat, a Fox News contributor, to serve as surgeon general; and former congressman Dave Weldon to head the Centers for Disease Control and Prevention.”
  • The HHS, Labor, and Treasury Secretaries are the principal Affordable Care Act regulators while the Office for Management and Budget carriers a lot of weight with the Office of Personnel Mangement.
  • The American Hospital Association News tells us,
    • “The AHA and 22 other organizations Nov. 22 urged Congress to pass an end-of-year health care package that includes action on alternative payment models and a scheduled physician payment cut. The organizations requested an extension of Medicare’s Advanced Alternative Payment Model incentive payments, ensure that APM qualifying thresholds remain attainable and replacement of a scheduled cut to Medicare physician payments with an update reflective of inflationary pressures.
    • “These payment reforms have generated more than $28 billion in gross savings for Medicare over the past decade,” the organizations wrote. “The Centers for Medicare & Medicaid Services (CMS) recently released results showing that the Medicare Shared Savings Program and [Accountable Care Organization] REACH Model, the largest APMs in Medicare, generated $2.8 billion in net savings for the Medicare program in 2023, while improving patient access and quality.”  
  • HHS’s HRSA shares information on federal government spending to improve rural healthcare.
  • Per MedTech Dive,
    • “The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
    • “The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
    • “The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastro renal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
    • “Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.”
  • Kevin Moss writing in Federal News Network offers an Open Season checklist for federal employees while FedWeek shares “11 FAQs: Open Season & PSHB/FEHB Switchover.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is stable or declining in most areas. Seasonal influenza activity remains low nationally. RSV activity is elevated and continues to increase in the southern, central, and eastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among young children in the United States.
    • “COVID-19
      • “Nationally, COVID-19 activity is stable or declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. COVID-19 activity is low with no meaningful changes in infection levels predicted.
      • “CDC expects that the 2024-2025 COVID-19 vaccine will work well for currently circulating variants. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is elevated and continues to increase in the southern and eastern United States. Activity is low in the rest of the country but increasing in the central and western United States. Emergency department visits and hospitalization rates are increasing in young children in the southern, central, and eastern United States.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.
    • “Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55.” * * *
    • “The child is recovering, and all family members tested negative for H5 avian influenza but positive for the same common respiratory virus as the child. Contact tracing continues, and there is no sign of human-to-human spread.
    • “Investigation into the child’s exposure to H5N1 is still under way, the CDC said.”
  • The New York Times reports,
    • “The number of deaths caused by alcohol-related diseases more than doubled among Americans between 1999 and 2020, according to new research. Alcohol was involved in nearly 50,000 deaths among adults ages 25 to 85 in 2020, up from just under 20,000 in 1999.
    • “The increases were in all age groups. The biggest spike was observed among adults ages 25 to 34, whose fatality rate increased nearly fourfold between 1999 and 2020.
    • “Women are still far less likely than men to die of an illness caused by alcohol, but they also experienced a steep surge, with rates rising 2.5-fold over 20 years.
    • “The new study, published in The American Journal of Medicine, drew on data from the Centers for Disease Control and Prevention.”
  • A Wall Street Journal reporter observes
    • “After years of pushing the benign myth that a glass of wine a day is good for the heart, it seems the medical establishment has abandoned hedonists and pleasure seekers. Is there a safe amount of alcohol? It turns out no. 
    • “For this and other more amorphous reasons, I have noticed increasing numbers of people around me are sober-ish. They drink only socially or only two glasses of wine a week or only in restaurants. They are not willing to give up drinking entirely, which feels like too vast and depressing a surrender of life’s pleasures. So they make rules for themselves. 
    • “Someone I know has a new ritual of drinking a nonalcoholic beer with nuts on her terrace. Another friend told me that she used to drop by for drinks at friends’ houses in the evenings, and now it is just as often tea.”
  • Medscape discusses the side effects of GLP-1 drugs.
    • “Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.
    • “But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).
    • “It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
    • “But that’s not really happening now,” she added.
    • “Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.”
  • KFF provides findings from its 2024 Women’s Health Survey concerning contraception.
  • Medical Economics informs us,
    • “More than one in five U.S. adults, which equates to 59.3 million people, were living with mental illnesses in 2022, yet just more than half of them (50.6%) had received treatment in the previous year. A new study, from West Health and Gallup, uncovered that 70% of Americans would prefer to be asked about both their physical health and their mental health during appointments with their primary care providers (PCPs).
    • ‘The West Health-Gallup Survey on Mental Health in America reported that 65% of men and 76% of women hoped to discuss both physical and mental health with their PCPs. The survey also found that 66% of U.S. adults have been asked about their mental health by their PCPs or family practitioners, whereas 32% of adults said that had never happened. Women were more likely than men (71% compared to 60%) to be asked about mental health.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “Yesterday, the US Centers for Disease Control and Prevention (CDC) closed its investigation into the multistate Listeria outbreak tied to Boar’s Head deli meat after 61 cases and 10 deaths were reported.”
  • The Food and Drug Administration announced,
    • “On Thursday, the FDA updated the outbreak advisory for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.”
  • The Washington Post reports,
    • “The Detroit-based Wolverine Packing Co. recalled more than 167,000 pounds of ground beef products because of concerns that the meat may be contaminated with E. coli, according to the U.S. Department of Agriculture. The recall affects fresh products that have a use-by date of Nov. 14 and frozen products whose labels contain a production date of Oct. 22, officials said.
    • “On Nov. 13, Minnesota’s Department of Agriculture alerted the Food Safety and Inspection Service, an agency of the USDA, about a group of people who had consumed ground beef before they fell ill.
    • ‘On Nov. 20, a ground beef sample collected by Minnesota officials tested positive for E. coli O157. Federal officials determined that the products from Wolverine Packing Co. were linked to the people who had become sickened in Minnesota.
    • “At least 15 patients have been identified, and the onset of their infections range from Nov. 2 to Nov. 10, the USDA said. At least two have been hospitalized, according to Minnesota officials.
    • “The recalled products have the establishment number EST. 2574B inside the USDA mark of inspection. The items were shipped to restaurant locations nationwide, according to officials.
    • Some products may be in restaurant refrigerators or freezers, officials said.
    • “Restaurants are urged not to serve these products.”

From the U.S. healthcare business front,

  • HR Dive relates,
    • “Insurers are projecting medical costs will increase globally in 2025 — by about 10.4%, according to WTW’s 2025 Global Medical Trends Survey.
    • “Specifically in the U.S., insurers project a 10.2% increase in 2025, up from 9.3% this year.
    • “Notably, WTW researchers said that public healthcare systems worldwide have been overwhelmed due to high demand and low resources, which has led to people turning to private providers.”
  • Health Leaders Media discusses an Oschner Health program with myLaurel which offers value-based medical care at home.
    • “Billing arrangements are a key difference between CMS’ Acute Hospital Care at Home program and Ochsner Health’s Acute Care at Home program.
    • “The Acute Care at Home program features virtual visits with physicians, nurses, and care managers as well as in-person visits with paramedics.
    • “By reducing hospital admissions and readmissions, the Acute Care at Home program is decreasing total cost of care.”
  • Investment News reports,
    • “Despite the benefits of health savings accounts as tax-advantaged retirement savings tools, employees are largely using them to meet current healthcare expenses, according to a new survey by the Plan Sponsor Council of America.
    • “The 2024 HSA Survey, sponsored by HSA Bank, reflects responses from more than 500 employers and shows modest growth in account balances and contributions. However, it also highlights a need for greater education around the long-term benefits of HSAs.
    • “While 90 percent of eligible employees had an HSA in 2023 and three-quarters made contributions, few are leveraging them for retirement planning.
    • “Among other key insights, the survey found that only one-third of employers educate workers about using HSAs as part of their retirement strategies, and fewer than 30 percent allow participants to view their HSA balances alongside retirement accounts for a more holistic view of savings. Less than 10 percent of employers mirror HSA investment options with those available in their 401(k) plans, though interest in doing so has grown.”
  • The Wall Street Journal reports,
    • “An industry fight against lucrative drug discounts for hospitals is intensifying as another drugmaker joins the battle: Sanofi.
    • “The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter. 
    • “The French company’s plan, which would take effect early next year, comes as the industry escalates its efforts to rein in the federal program known as 340B. Eli Lilly and Johnson & Johnson this month filed separate lawsuits against the federal government for rejecting the companies’ plans to tighten the way they provide the discounts to hospitals in the program.” 
  • Per BioPharma Dive,
    • “Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.
    • “The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday. 
    • “With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.”

Monday Round up

David Ermer–CDC, FDA, Federal employment benefits, Generative AI, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network Interviews Consumer Checkbook’s Kevin Moss “on how a little planning can offset rise in premium costs” when selecting an FEHB or PSHB plan for 2025.
  • KFF examines Plan Offerings, Premiums and Benefits in Medicare Advantage Plans During the Medicare Open Enrollment Season for Coverage in 2025.
  • The American Hospital Association tells us,
    • “To recognize National Rural Health Day Nov. 21, AHA has released a blog and infographic that address challenges in accessing rural behavioral health care and approaches to solving them, respectively. From Nov. 18-22, AHA will honor our rural workforce by sharing rural health content through AHA Today, social media and other channels.” 
  • The Congressional Research Service released a Focus report about the qualified medical expenses that health savings account (“HSA”) holders can use the HSA to pay.
  • BioPharma Dive lets us know,
    • “Massachusetts-based Syndax Pharmaceuticals won Food and Drug Administration approval Friday for a new kind of drug to treat an aggressive form of leukemia in adults and some children.
    • “The oral drug, which Syndax will sell as Revuforj, is the first of its type, a class of compounds known as menin inhibitors. It’s cleared for patients one year or older who have relapsed or refractory acute leukemia that harbors a specific mutation: translocations in the lysine methyltransferase 2A, or KMT2A, gene.
    • ‘People with this type of leukemia are more likely to relapse and have a median overall survival of less than one year. Syndax plans to launch two doses of the drug, which it priced at about $475,000 per year before rebates or discounts, later in November. A lower dose for patients who weigh less will be available next year.”

The public health and medical research front,

  • The New York Times reports,
    • “One of the first warnings came in a paper published in 2021. There was an unexpected rise in pancreatic cancer among young people in the United States from 2000 to 2018. The illness can be untreatable by the time it is discovered, a death sentence.
    • “With publication of that report, by Dr. Srinivas Gaddam, a gastroenterologist at Cedars-Sinai Medical Center, researchers began searching for reasons. Could the increase be caused by obesity? Ultraprocessed foods? Was it toxins in the environment?
    • “Alternatively, a new study published on Monday in The Annals of Internal Medicine suggests, the whole alarm could be misguided.
    • “The authors of the paper, led by Dr. Vishal R. Patel a surgical resident at Brigham and Women’s Hospital in Boston, did not dispute the data showing a rising incidence. They report that from 2001 to 2019 the number of young people — ages 15 to 39 — diagnosed with pancreatic cancer soared. The rate of pancreatic surgeries more than doubled in women and men.
    • “The problem is that the expected consequence of such a rise in cancers did not occur. With more pancreatic cancers in young people, there should be more pancreatic cancer deaths. And there were not. Nor were more young people getting diagnosed with later-stage cancers. Instead, the increase was confined to cancers that were in very early stages.
    • “Many cancers will never cause harm if left alone, but with increasingly sensitive tools, doctors are finding more and more of them. Because there usually is no way to know if they are dangerous, doctors tend to treat them aggressively. But they would never have shown up in death statistics if they had not been found.
    • “It’s the hallmark of what researchers call overdiagnosis: a rise in incidence without a linked rise in deaths.”
  • STAT News informs us
    • “At the Milken Institute’s Future of Health Summit on Thursday, researchers and health care executives talked about efforts to detect cancers earlier, save lives, and get to the root of why cancers have begun to rise in this population. 
    • “The big question is always why,” said Kimryn Rathmell, director of the National Cancer Institute. “We need to understand the variation so that we can begin to understand which parts are related to obesity, diet and exercise; which ones are more related to sun exposure, smoking, alcohol — the risk factors that are well-known to us, but may have a variation in how they’re being consumed or exposed in younger people today.” * * *
    • “Since cancer is still rare among younger adults, people are likely to get negative test results. That “runs the risk of people, by the time they get older, kind of shrugging their shoulders and saying, ‘Well, I’ve been doing this for 10 years, why should I keep doing it?’” said Harlan Levine, president of health innovation and policy at the City of Hope.
    • “Part of the solution, the group agreed, is to develop more efficient, targeted tests that can detect cancers earlier on. Mohit Manrao, the head of U.S. oncology at AstraZeneca, noted that the company has recently developed an AI tool that can use biomarkers from common hospital tests to predict the likelihood that a person will get a disease, including some cancers, before a doctor would be able to make a diagnosis.
    • “It’s also important to expand outreach to populations that haven’t had access to it in the past. Black women, for example, have a lower incidence of breast cancer than white women but 40% higher chance of dying from it.”
  • and
    • “Lipoprotein(a) is a risk factor for cardiovascular disease you may not hear about in your annual physical. Like LDL, or “bad” cholesterol, too much of the LDL-like particle can create plaque that clogs arteries, creating potential blockages that lead to heart attacks or strokes. It’s also implicated in aortic stenosis, when the aortic valve narrows, pinching blood supply to the rest of the body.
    • “But unlike cholesterol, Lp(a) does not surrender to statins or respond to a healthier lifestyle of improved diet and more physical activity. Its levels are determined by your genes, putting the estimated 1 in 5 people who have high levels at a two- or threefold higher risk than people without what’s called the most common genetic dyslipidemia. In the United States, that would mean 64 million people are at risk and 1.4 billion people worldwide.
    • “At the American Heart Association’s scientific sessions Monday, researchers presented Phase 2 data on two treatments for elevated Lp(a): an oral drug called muvalaplin and an RNA-silencing injection called zerlasiran. Both studies were also published in JAMA and include several of the same co-authors, led by Steven Nissen of the Cleveland Clinic and Stephen Nicholls of Monash University.
    • “These two new reports add to the growing evidence in at least five different drug programs directed for lowering Lp(a) that the agents are potent, capable of 80% reduction or more, with durable effects over extended treatment,” said Eric Topol, cardiologist and geneticist and director of the Scripps Research Translational Institute. He was not involved in either study. “Most of the programs are siRNA injectables but one here is oral, which is encouraging, more practical, and may be less expensive.”
  • Per Medscape,
    • “Artificial intelligence (AI) helps produce echocardiograms more quickly and efficiently, with better-quality images and less fatigue for operators, shows the first prospective randomized controlled trial of AI-assisted echocardiography.
    • “The Japanese study used Us2.ai software, developed from an 11-country research platform and supported by the Singapore Agency for Science, Technology and Research. This system and another newly developed AI system, PanEcho — developed at the Yale School of Medicine in New Haven, Connecticut, and the University of Texas at Austin — can automatically analyze a wide range of structures, functions, and cardiographic views. Studies of these two systems were presented at the American Heart Association (AHA) Scientific Sessions 2024.“
  • Per MedPage Today,
    • “More than half of all adults in the U.S. are eligible for semaglutide (Ozempic, Wegovy, Rybelsus), researchers estimated.
    • “Among 25,531 participants in the National Health and Nutrition Examination Survey (NHANES) from 2015 to 2020, 8,504 were eligible for semaglutide, representing an estimated 136.8 million adults across the country. All met the criteria for at least one of three indications that the drug is currently approved for — diabetes, weight management, or secondary cardiovascular disease (CVD) prevention, reported Dhruv S. Kazi, MD, MSc, of Beth Israel Deaconess Medical Center in Boston, and colleagues.”
  • The Washington Post adds,
    • “From August 2021 to August 2023, 4.5 percent of adults in the United States had undiagnosed diabetes, the Centers for Disease Control and Prevention says in a recent report. And a little over 11 percent of U.S. adults had been diagnosed with the condition as of the same time period, the CDC says.” * * *
    • “The study looked at how total, diagnosed and undiagnosed diabetes differed across demographics including age, weight and educational attainment. Undiagnosed diabetes prevalence increased with age. For example, about 1.3 percent of adults ages 20 to 39 with diabetes were undiagnosed vs. 5.6 percent of those 40 to 59. Among those 60 and older, some 6.8 percent of people with diabetes had not been diagnosed.”
  • The American Medical Association shares “what doctors wish patients knew about sciatica.”
  • Per BioPharma Dive,
    • “A single infusion of a CRISPR therapy developed by Intellia Therapeutics showed promising signs of stabilizing a heart disorder caused by the rare disease transthyretin amyloidosis, buoying the company’s hopes of finding success in late-stage clinical trials.
    • “Phase 1 study data from 36 people with the cardiomyopathy form of transthyretin, or ATTR, amyloidosis showed Intellia’s gene editing treatment sharply and durably lowered levels of the ATTR protein that misfolds and gathers in the toxic clumps that characterize the disease.
    • “Prior trial results, in fewer people and across shorter periods of time, had already shown Intellia’s therapy capable of reducing ATTR protein. The new findings, which were published Friday in The New England Journal of Medicine, show those reductions appeared to translate to stability or improvement on several markers of cardiac disease progression, too.”
  • Per a National Institutes of Health press release,
    • “Researchers from the National Institutes of Health (NIH) have developed an artificial intelligence (AI) algorithm to help speed up the process of matching potential volunteers to relevant clinical research trials listed on ClinicalTrials.gov. A study published in Nature Communications(link is external) found that the AI algorithm, called TrialGPT, could successfully identify relevant clinical trials for which a person is eligible and provide a summary that clearly explains how that person meets the criteria for study enrollment. The researchers concluded that this tool could help clinicians navigate the vast and ever-changing range of clinical trials available to their patients, which may lead to improved clinical trial enrollment and faster progress in medical research.
    • “A team of researchers from NIH’s National Library of Medicine (NLM) and National Cancer Institute harnessed the power of large language models (LLMs) to develop an innovative framework for TrialGPT to streamline the clinical trial matching process. TrialGPT first processes a patient summary, which contains relevant medical and demographic information. The algorithm then identifies relevant clinical trials from ClinicalTrials.gov for which a patient is eligible and excludes trials for which they are ineligible. TrialGPT then explains how the person meets the study enrollment criteria. The final output is an annotated list of clinical trials—ranked by relevance and eligibility—that clinicians can use to discuss clinical trial opportunities with their patient.
    • “Machine learning and AI technology have held promise in matching patients with clinical trials, but their practical application across diverse populations still needed exploration,” said NLM Acting Director, Stephen Sherry, PhD. “This study shows we can responsibly leverage AI technology so physicians can connect their patients to a relevant clinical trial that may be of interest to them with even more speed and efficiency.”
    • “To assess how well TrialGPT predicted if a patient met a specific requirement for a clinical trial, the researchers compared TrialGPT’s results to those of three human clinicians who assessed over 1,000 patient-criterion pairs. They found that TrialGPT achieved nearly the same level of accuracy as the clinicians.”
  • Per Healio,
    • “Most people at high risk for lung cancer have not discussed screening for the disease with their clinician or have even heard of the test, according to a research letter published in JAMA Network Open.
    • “The findings come despite lung cancer screening demonstrating effectiveness at identifying cancer and reducing related mortality outcomes, a researcher pointed out.
    • “We’ve got a screening test that works. It works as well, if not better, than breast and colorectal cancer screening in terms of mortality reduction. It’s one of the most life-saving things we have for a cancer that kills more people than either of those two combined,” Gerard A. Silvestri, MD, MS, FCCP, a professor of medicine at the Medical University of South Carolina (MUSC) and the study’s senior author, said in a press release.
    • “Silvestri and colleagues noted that physician-patient communication is vital for the uptake of lung cancer screening, which only 18% of eligible patients are up to date on, according to a prior study published in JAMA Internal Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive reflects,
    • “Despite growing revenues, most major insurers saw their profits from offering health plans shrink in the third quarter as pressures in government programs stretched into the back half of the year.
    • “In Medicare Advantage, seniors are still utilizing more healthcare than insurers expected when pricing their plans. And in Medicaid, states’ payment rates continue to land well below the cost of caring for beneficiaries in the safety-net programs, payers say.
    • “Those forces coalesced to hit insurers, slamming some — notably, CVS-owned Aetna and Humana — while swatting others. Aetna was particularly affected, posting the steepest year-over-year drop in operating profit by a wide margin.
    • “Only two insurers — Cigna and Molina — reported a year-over-year increase in operating profit from insurance arms: Cigna, because most of its members are in commercially insured plans, which shelters the payer from headwinds in government plans; and Molina due to risk corridors that absorbed the worst of unexpected cost trends, and rate updates from Medicaid states. 
    • “Yet overall, medical loss ratios — an important metric of spending on patient care — increased 3.3 percentage points year over year when averaged across the seven major publicly traded payers. That’s a major leap. Again, Aetna saw the most drastic change — and management warned investors the MLR could increase further, from 95.2% this quarter to 95.5% in the fourth.”
  • The Wall Street Journal adds,
    • “CVS Health is adding four new members to its board in an agreement with Glenview Capital Management, a hedge fund that pushed for changes at the healthcare company.
    • “The new members include Glenview Chief Executive Larry Robbins, as well as three other executives with health-sector and financial experience. The board’s total membership will be 16 with the new additions.
    • ‘Robbins and CVS Executive Chairman Roger Farah said the company and the investor had agreed to cooperate. 
    • “The board members that are joining bring unique skills, they’ll be additive to the existing board, and we expect to work collaboratively,” Farah said in an interview.”
  • Beckers Hospital Review offers eight predictions about hospital financial stability in 2025 based ona a November 13 report issued by Moody’s Investor Services.
  • Modern Healthcare reports,
    • “Ascension Wisconsin plans to close a hospital in Waukesha and consolidate a few lines of service among other facilities in the southeast region of the state.
    • “The Waukesha “micro-hospital,” which offers emergency and low-acuity care services, is slated to shut down in January, said Ascension Wisconsin Senior Director of External Relations Mo Moorman on Monday.
    • “The facility is part of a joint venture between Glendale-based Ascension Wisconsin and micro-hospital developer Emerus, which staffs and manages the location. The decision to close was due to consistently low patient volumes, Moorman said.
    • “Other facilities run by the joint venture will not be affected.”

Midweek Update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Roll Call reports,
    • “Sen. John Thune [R SD] on Wednesday was elected the next Senate majority leader, as Republicans are set to take over the chamber in January — and with a demanding President-elect Donald Trump poised to return to power.
    • “Having defeated Texas Sen. John Cornyn and Florida Sen. Rick Scott, the fourth-term South Dakotan will replace Mitch McConnell of Kentucky in January as the chamber’s top Republican. McConnell had held the top GOP spot since taking his party’s leadership reins in early 2007, making him minority leader in six Congresses and majority leader in three Congresses.
    • “Thune defeated Cornyn 29-24 on the day’s second ballot, with Scott eliminated from contention after the first ballot, according to a source inside the Capitol’s Old Senate Chamber, where Republicans chose their next leader.
    • “Senate Republicans also selected Sens. James Lankford, R-Okla., as Republican Conference vice chair; Shelley Moore Capito, R-W.Va., as Republican Policy Committee chair; John Barrasso, R-Wyo., as assistant majority leader; Tim Scott, R-S.C., as National Republican Senatorial Committee chair; and Tom Cotton, R-Ark., as Republican Conference chair.”
  • Tuesday night, the AP results for control of the House now stand at 218 Republicans vs. 208 Democrats with 218 seats constituting a majority. Decision Desk HQ already had awarded control of the House to the Republicans, 219 Republicans vs. 211 Democrats.
  • Federal News Network lets us know,
    • “The House passed the Social Security Fairness Act Tuesday evening in a vote of 327 to 75, bringing the removal of the Windfall Elimination Provision and the Government Pension Offset closer than ever to reality.
    • “Social Security’s WEP and GPO have been around for decades. The two provisions reduce and, in some cases, fully cancel out Social Security benefits for Civil Service Retirement System annuitants and other public sector employees who have worked in state and local government, as well as their spouses, widows and widowers.
    • “The House’s vote came after Reps. Abigail Spanberger (D-Va.) and Garret Graves (R-Pa.), the original cosponsors of the reintroduced Social Security Fairness Act, filed a discharge petition in September to try to push the bill toward a vote. About one week later, the petition reached the 218-signature threshold needed to force the bill to the House floor.” * * *
  • OPM yesterday released a fact sheet titled OPM Highlights its Key Actions under Biden Administration’s AI Executive Order.
  • Govexec tells us,
    • “The Office of Personnel Management reported a slight increase in the backlog of pending federal employee retirement claims in October, though still a marked improvement from the same period last year.
    • “OPM received 6,872 new retirement requests from departing federal workers last month, an increase of around 1,250 more claims than in September. Though OPM cleared 6,458 claims—itself an increase of around 150 claims from the previous month—the backlog ticked up by around 400 cases to 14,908. OPM’s goal is a “steady state” of 13,000 pending retirement claims.
    • “Despite that, the average time it takes to process a retirement claim fell from 63 to 62 days, as measured on a monthly basis.” * * *
    • Now the legislation faces its next hurdle: passage in the Senate. The Senate’s companion to the Social Security Fairness Act currently has 62 cosponsors. * * *
    • “Unlike the House, the Senate does not have a discharge petition procedure — the strategy that Spanberger and Graves used to force the floor vote in the House.
    • “In the Senate, we have the votes to defeat a filibuster, but it has to be brought to a vote,” John Hatton, NARFE’s staff vice president of policy and programs, told The Federal Drive with Tom Temin. “But somebody may object to proceeding, which could cause a two-week or so delay in getting it through.”
  • Per a government press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), announced today the launch of the Behavioral Health Workforce Career Navigator, designed to help current and aspiring behavioral health professionals identify state requirements for a range of behavioral health careers. The navigator supports President Biden and Vice President Harris’ commitment to expanding America’s behavioral health workforce, a key element of the Administration’s Unity Agenda for the Nation.”

From the public health and medical research front,

  • National Institutes of Health Director Dr. Monica Bertagnolli writes in her blog, about “Advancing a Whole-Person Approach to Women’s Health Research.”
    • “NIH has committed $200 million in fiscal year 2025 to supporting cross-cutting research focused on the health needs of women. We also issued a Notice of Special Interest to highlight our interest in receiving project applications on diseases and conditions that impact women differently, disproportionately, and uniquely across nearly all NIH Institutes and Centers. We are already considering close to 300 new applications for women’s health research projects.
    • “The whole-person approach to women’s health allows researchers and clinicians to address unique needs throughout a woman’s lifetime and to provide a more complete picture of women’s health. It also must be integrated into all stages of the research process—from identifying innovative research questions, to producing impactful scientific and clinical results, to developing ways to equitably adopt new treatments. It begins with science that convenes researchers and clinicians from different disciplines to accelerate progress through combined efforts and knowledge. The White House Initiative on Women’s Health Research calls for this comprehensive approach, renewing NIH’s commitment to research that addresses the needs of women everywhere. It demands that we approach this work with urgency, putting women and their lived experiences at its center of a focus on translating insights from biology and society into better health.
    • “Links:
  • The Washington Post reports,
    • “A Canadian teenager infected with bird flu — that country’s first case involving a locally acquired infection — is in critical condition and experiencing difficulty breathing, health officials said Tuesday.
    • “The previously healthy British Columbia teen went to a hospital emergency room Nov. 2 with initial symptoms of pink eye, fever and cough, conditions common to many respiratory illnesses, Bonnie Henry, provincial health officer, said during a news conference. The teen was sent home.
    • “But after the patient’s condition deteriorated, the teen was admitted to BC Children’s Hospital in Vancouver late Friday.
    • “So far, no one who came into contact with the teen has fallen ill.” * * *
    • “On Wednesday, the Public Health Agency of Canada confirmed the H5N1 diagnosis in the teen and said genomic sequencing indicates the virus is related to the bird flu viruses from the ongoing outbreak in poultry in British Columbia, which is related to wild birds.”
  • STAT News informs us,
    • “U.S. drug overdose deaths are plummeting, putting the country on pace for its first year with fewer than 100,000 overdose deaths since 2020 — a powerful, if bleak, symbolic milestone.
    • “Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087, according to new statistics released this week by the Centers for Disease Control and Prevention. 
    • “The epidemic’s toll remains immense but is substantially lower than the 111,615 lives lost to overdose during the 12 months ending in June 2023. Fentanyl, the potent illicit opioid that now dominates the U.S. illicit drug supply, contributed to a large majority.” 
  • Per Health Day,
    • “Even as the pressures of the pandemic began to ebb, Americans’ growing dependence on alcohol did not, a troubling new study shows.
    • “Two years into the globe-altering health crisis, the percentage of Americans who consumed alcohol — which had already spiked between 2018 and 2020 — inched even further up in 2021 and 2022. Not only that, but more folks reported heavy or binge drinking, the findings published Tuesday in the Annals of Internal Medicine revealed.
    • “Our results provide national data to draw further attention to the potential alcohol-related public health effects that may remain from the pandemic,” the researchers wrote in their research. “Potential causes of this sustained increase include normalization of and adaptation to increased drinking due to stress from the pandemic and disrupted access to medical services.” 
  • Per MedTech Dive,
    • “Livanova said Monday a trial of its obstructive sleep apnea (OSA) implant met its primary safety and efficacy endpoints, positioning the company to seek approval once the analysis is complete.  
    • “The randomized trial linked Livanova’s aura6000 to improvements on measures of OSA severity and blood oxygen after six months of treatment with the hypoglossal nerve stimulator. The hypoglossal nerve controls the tongue muscles.
    • “Leerink Partners analysts said the results were largely in line with outcomes seen in a trial of Inspire Medical Systems’ rival device. The analysts see ways that Livanova could differentiate its device but said the company “may have a difficult time breaking into the sleep apnea market.”
  • Fierce Pharma points out,
    • “Following an impressive data drop this summer highlighting the potential for Eli Lilly’s tirzepatide to stave off progression to Type 2 diabetes in prediabetic patients, the Indianapolis-based drugmaker is laying out full results from its longest completed study of the dual GIP/GLP-1 receptor agonist to date.
    • “In the three-year SURMOUNT-1 trial, tirzepatide curbed the risk of disease progression to Type 2 diabetes by 94% versus placebo in adult prediabetes patients who were obese or overweight, Lilly said in a release Wednesday. The number represents a pooled result from three tirzepatide doses (5 mg, 10 mg and 15 mg) studied in the trial.
    • “Putting those results into perspective, one new case of diabetes could be prevented for every nine patients treated with tirzepatide, which is marketed in the U.S. as Mounjaro for Type 2 diabetes and as Zepbound for obesity, Lilly said.
    • “Overall, nearly 99% of patients on tirzepatide remained diabetes-free at the end of the trial’s 176-week treatment period, the company added. 
    • ‘Further, at the 193-week mark, which followed a 17-week off-treatment follow-up period, only 2.4% of patients on Lilly’s drug were diagnosed with Type 2 diabetes compared to 13.7% of patients in the study’s placebo cohort.
  • Beckers Hospital Review identifies “nine new drug shortages to know, according to databases compiled by the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Self-funded employer clients of Aetna have access to SimplePay Health, a new healthcare plan design that provides employees and other plan members with essentially an interest-free line of credit to pay for care and requires no out-of-pocket costs due at the time of service, Aetna said in a Oct. 15 press release.
    • “The plan requires only copays for medical services and prescription drugs up to the plan member’s out-of-pocket maximum, with no deductibles or coinsurance costs. Each plan member is mailed a monthly statement — which Aetna compared to a credit card statement — that summarizes all medical and pharmacy claims from the prior 30 days.
    • “Payment terms are generally chosen by the plan sponsor, Amie Benedict, president, diversified commercial solutions at Aetna, said in an email to HR Dive, but payment plans are generally between 12 to 18 months long. “SimplePay will work with members requiring longer payment periods,” Benedict said.” * * *
    • “Aside from SimplePay, UnitedHealthcare company Surest also offers a plan model to self-funded employers without coinsurance or deductibles.
    • “Jim Winkler, chief strategy officer at the Business Group on Health, said in an interview that SimplePay, Surest and similar products are designed to curate a set of preferred healthcare providers and encourage plan members to use these providers by keeping down out-of-pocket costs.
    • “This is especially the case for “shoppable” care, or care that is neither urgent nor emergency in nature and for which employees can select from a variety of providers, Winkler said. “In these shoppable moments, these programs are designed to ensure that the right choice is the easy choice.”
  • Fierce Healthcare fills us in on the first day of its Fierce Health Payer Summit here in beautiful Austin Texas.
  • Corporate Synergies exposes “The Myths Preventing Employees from Embracing HSA-Qualified Plans.”
  • Per BioPharma Dive,
    • “BioNTech is buying into one of the hottest areas of oncology, agreeing to pay $800 million to acquire China-based Biotheus and, with it, a type of drug some analysts think could rival Merck & Co.’s dominant immunotherapy Keytruda.
    • “The deal will hand BioNTech full global rights to a dual-targeting drug that’s designed to block two proteins: the PD-L1 “checkpoint” targeted by Keytruda and another called VEGF that’s coopted by tumors to fuel their growth.
    • “This specific type of “bispecific antibody” is newly on drugmakers’ radar screens after Summit Therapeutics wowed the cancer field with data showing its drug ivonescimab outperformed Keytruda in a head-to-head lung cancer trial.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Republican lawmakers returned to Capitol Hill on Tuesday with some spring in their step.
    • After winning the presidency and the Senate majority, the party is on the cusp of regaining the House majority — and with it, a powerful governing trifecta in Washington.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.”
  • The Post must be tracking the AP results (214 – 206) because Decision Desk HQ has decided that the Republicans do have a majority of seats in the House (219 – 210, 218 being a majority).
  • The Wall Street Journal reports,
    • “President-elect Donald Trump picked Tesla CEO Elon Musk and biotech company founder Vivek Ramaswamy, a former Republican presidential candidate, to lead an effort to cut spending, eliminate regulations and restructure federal agencies.
    • “Trump said in a statement Tuesday night that Ramaswamy and Musk—the wealthiest person in the world, who oversees six companies including Tesla—would lead what the president-elect called the Department of Government Efficiency, or DOGE. The department’s mandate is to streamline government bureaucracy, the president-elect said.
    • “DOGE will operate outside of the federal government, Trump said, and will work with the White House Office of Management and Budget to implement its recommendations.” 
  • The American Hospital Association News lets us know,
    • “In comments Nov. 12 to majority and minority leaders of the House and Senate, the AHA requested that Congress act on key priorities for hospitals and health systems before the end of 2024. AHA urged Congress to continue providing relief from Medicaid Disproportionate Share Hospital Payment cuts; continue the Medicare-dependent Hospitals and Low-volume Adjustment programs that expire Dec. 31; reject site-neutral payment proposals; and pass the Improving Seniors’ Timely Access to Care Act (H.R. 8702/ S. 4532), legislation that would reduce the wide variation in prior authorization methods in the Medicare Advantage program.” * * * 
    • “AHA also urged Congress to extend the hospital-at-home waiver for five years through 2029; mitigate scheduled physician reimbursement cuts for 2025; and pass the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), legislation that would provide federal protections from workplace violence for hospital workers, similar to protections for airport and airline workers.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 12 released a report evaluating past and present approaches to rural health. It shares how previous CMS Innovation Center models focusing on rural health have been applied to recent model development. 
    • “The report also shares themes, concepts and next steps gathered from its rural health “Hackathon,” a series of events across the U.S. that brought experts together to brainstorm solutions to rural health challenges. The top themes highlighted a need for training, regulatory changes and collaboration to help improve access to care and support transformation. The report also outlines possible considerations for future Accountable Care Organization-focused and other models.
    • “CMS’ next intention is to issue a request for application to fill the 10 open spaces for its Rural Community Hospital Demonstration. The program was directed by Congress and requires a test of cost-based payment for Medicare inpatient services for rural hospitals with fewer than 51 beds that are ineligible for critical access hospital status.”
  • OPM issued a press release today about the ongoing Open Season while Govexec informs us,
    • “Retired and active federal employees find selecting a health care plan to be more confusing than creating a will, reading Shakespeare, learning a new language or navigating a divorce, according to a new survey from the National Active and Retired Federal Employees Association. 
    • “While the process may be complex, NARFE is urging current and former federal and postal employees to look at their options for health care insurance carriers and coverage plans during this year’s open season, which lasts from Nov. 11 through Dec. 9, especially in light of premium price increases next year that will be the largest in recent memory. 
    • “John Hatton, NARFE’s staff vice president of policy and programs, told Government Executive that enrollees could be missing out on thousands of dollars in savings. 
    • “We always recommend people to take a look at their options during open season to make sure they have the coverage that they need so they’re not paying more in out-of-pocket expenses later, but also to pay less in premiums if they don’t need the coverage that they currently have,” he said. 
    • “More than half of active federal employees (57%) and retired ones (55%) in NARFE’s survey annually review their health insurance options. For this year’s open season, 60% of current feds responded that they are planning on participating compared to 47% of retirees.” 
  • RAND shares survey results about U.S. veterans’ families, which should be of interest to FEHB carriers as the federal government wisely hire a lot of veterans.
  • Meanwhile, AHIP fact checks a Wall Street Journal article criticizing the Medicare Advantage program.
  • The New York Times reports,
    • “The Justice Department and four Democratic state attorneys general on Tuesday filed an antitrust lawsuit against the giant UnitedHealth Group in an attempt to block its $3.3 billion deal to take over Amedisys, a large home health company.
    • “Unless this $3.3 billion transaction is stopped, UnitedHealth Group will further extend its grip to home health and hospice care, threatening seniors, their families and nurses,” Jonathan Kanter, the assistant attorney general who heads the department’s antitrust division, said in a statement on Tuesday.“
  • The Wall Street Journal adds,
    • “Johnson & Johnson launched a legal challenge against a federal health agency blocking the company’s quest to tighten the way it provides lucrative drug discounts to hospitals.
    • “J&J filed a lawsuit in federal court in Washington on Tuesday against the heads of the U.S. Department of Health and Human Services and one of its agencies, seeking a court ruling that says J&J’s plan is legal and to prevent the agency from rejecting it.
    • “The lawsuit escalates the pharmaceutical industry’s fight to rein in the federal drug-discount program known as 340B. The program, created in 1992, requires drugmakers to provide steep discounts on outpatient drugs to hospitals and clinics that serve uninsured and low-income patients. 
    • “The pharmaceutical industry has argued that the 340B program has strayed from its original purpose of helping safety-net hospitals. Manufacturers say they sell medicines to covered hospitals at steep discounts, but some large hospitals mark up the prices charged to both uninsured patients and insurers.”

From the public health and medical research front,

  • The New York Times reports,
    • “After decades of unrelenting increases, rates of sexually transmitted infections in the United States are showing hints of a downturn.
    • “Diagnoses of gonorrhea dipped in nearly all age groups last year, compared with 2022, and new cases of syphilis and chlamydia remained about the same, according to data released on Tuesday by the Centers for Disease Control and Prevention.
    • “The results are not yet cause for celebration.
    • “Overall, more than 2.4 million new S.T.I.s were diagnosed last year, about a million more than the figure 20 years ago. Nearly 4,000 babies were diagnosed with congenital syphilis last year, and 279 of them were stillborn or died soon after.
    • “Still, experts said they were cautiously optimistic that a resurgent tide of infections was beginning to turn.”
  • Per a National Institutes of Health press release,
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have discovered a new way in which RAS genes, which are commonly mutated in cancer, may drive tumor growth beyond their well-known role in signaling at the cell surface. Mutant RAS, they found, helps to kick off a series of events involving the transport of specific nuclear proteins that lead to uncontrolled tumor growth, according to a study published Nov. 11, 2024, in Nature Cancer.
    • “RAS genes are the second most frequently mutated genes in cancer, and mutant RAS proteins are key drivers of some of the deadliest cancers, including nearly all pancreatic cancers, half of colorectal cancers, and one-third of lung cancers. Decades of research have shown that mutant RAS proteins promote the development and growth of tumors by activating specific proteins at the cell surface, creating a constant stream of signals telling cells to grow.” * * *
    • “The study also found evidence that mutant RAS proteins perform this same function in other cancer types, suggesting that this mechanism may be a general feature of cancers with mutated RAS genes.
    • “The researchers believe their finding may have potential applications for the treatment of RAS-fueled cancers. They have started to look at how this function for RAS works in pancreatic cancer in particular because there are so few effective treatments for this type of cancer.
    • “New treatment combinations could one day be developed that take this new role for RAS into consideration,” Dr. [Douglas] Lowy said.”
  • Health Day tells us,
    • “Lives lost to obesity-related heart disease have nearly tripled over the past twenty years, a new study reports.
    • “Heart disease deaths linked to obesity increased 2.8-fold between 1999 and 2020, according to findings presented today at the American Heart Association’s annual meeting in Chicago.
    • “The increase occurred especially among middle-aged men, Black adults, Midwesterners and rural residents, researchers found.
    • “Obesity is a serious risk factor for ischemic heart disease, and this risk is going up at an alarming rate along with the increasing prevalence of obesity,” lead researcher Dr. Aleenah Mohsin, a post-doctoral research fellow at Brown University in Providence, R.I., said in a news release.” * * *
    • “The National Institute of Health has more on the health risks of obesity.”

From the U.S. healthcare business front,

  • Fierce Healthcare surveys the major payors’ third quarter financial results as the curtain falls on the third quarter announcement season.
  • Kaufmann Hall relates,
    • “Though most indicators were down, hospital performance remained relatively stable overall, according to September data. Both inpatient revenue and average lengths of stay increased.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • and
    • “In the third quarter of this year, the median investment/subsidy per physician was $304,312—rising above $300,000 for the first time. Other expense metrics such as the total direct expense per provider FTE and labor as a percentage of total expenses increased.
    • “The Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Per Modern Healthcare,
    • “Ochsner Health may expand its hospital-at-home program throughout the entire health system after successfully piloting a program in New Orleans, the nonprofit healthcare provider said Tuesday.
    • “Ochsner Health said in a news release the pilot, launched in March at Ochsner Medical Center-New Orleans, prevented either initial hospitalizations or 15-day hospital readmissions for 92% of the patients referred to the program through its emergency department and observation unit.
    • “The New Orleans-based health system offered the service through a partnership with myLaurel, a New York-based company that provides transitional and acute care to frail, elderly patients at home instead of a hospital. Patients received virtual and in-home visits from clinicians, along with lab work, medications, education about treatment plans and other services.”
  • and
    • “Cardinal Health has entered definitive agreements to acquire a majority stake in GI Alliance, a gastroenterology management services organization, and the entirety of Advanced Diabetes Supply Group, a diabetes medical equipment supplier. 
    • “Cardinal expects to acquire Advanced Diabetes Supply for an estimated $1.1 billion and 71% ownership of GI Alliance for an estimated $2.8 billion. Both deals are expected to close by early 2025, pending regulatory approvals.” 
  • STAT News relates
    • “23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research.
    • “In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic data it had collected not only to assist drug companies but to become one itself.”
  • Per Healthcare Dive,
    • “General Catalyst released new details on its planned acquisition of Akron, Ohio-based Summa Health on Thursday, roughly one year after the venture capital firm said it was looking to buy a health system. 
    • “General Catalyst’s Health Assurance Transformation business, or HATCo, has signed a definitive agreement to purchase Summa for $485 million. The deal, alongside the health system’s current cash on hand, allows Summa to eliminate $850 million in debt — nearly all the debt the health system currently holds, according to Summa’s most recent financial results.
    • “HATCo is also pledging to spend $350 million over the first five years of its ownership to support routine operations and technology investments, plus another $200 million over seven years for “strategic and transformative” initiatives.” 
  • Per MedTech Dive,
    • “Johnson & Johnson said Tuesday it received an investigational device exemption (IDE) from the Food and Drug Administration to start a U.S. clinical trial for its Ottava surgical robot.
    • “The company said it will now prepare U.S. sites to receive Ottava systems, enroll patients and begin surgical cases as it focuses on training clinical trial investigators. J&J’s soft tissue robot will compete with Intuitive Surgical’s da Vinci system, which currently leads the market.
    • “The Ottava platform will incorporate J&J Ethicon surgical instruments designed for the robotic platform, the company said. Ottava will also have a digital system called Polyphonic that will connect surgical technologies, robotics and software, ultimately adding data and insights to support clinical decision making.”
  • and
    • “GE Healthcare has struck a deal to combine its Senographe Pristina mammography system with Radnet’s artificial intelligence-based Smartmammo workflow, the companies said Monday.
    • “The alliance positions GE to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow. The integration is the first part of a broader collaboration focused on imaging AI.
    • “Radnet CEO Howard Berger told analysts on an earnings call Monday that the mammogram systems “simply need a power source and a connection to the internet,” creating opportunities to image patients in “Walmart and mall locations.”

Weekend Update

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

From Washington, DC

  • Congress returns from the campaign trail on Tuesday to begin its lame duck session. Here is a link to this week’s Congressional Committee schedule. The continuing resolution funding the federal government expires on December 20, 2024.
  • The Federal Employee Benefits Open Season begins at 12:01 am ET Monday morning.
  • Here is a link to an Open Season advice column written by Ann Werts in FedSmith. Ms. Werts makes an interesting observation:
    • “Once you’ve determined what you’re going to compare in the plans you’re considering, there are a couple of great tools you can use to assist you. [Checkbook’s] guidetohealthplans.org is a 3rd party resource that enters the outline of coverage for every federal health plan each year. For a small subscription fee ($15.95), you can access their website to compare any set of plans. Some agencies pay for their employees to use it, so check first to see if it’s available directly through your agency. If not, you can use the code GUIDE20 to receive a 20% discount. 
    • “OPM also provides an online comparison tool. I find it more challenging to use because the output is a 17-column spreadsheet.” 
  • As Leonardo DaVinci observed, “Simplicity is the ultimate sophistication.” 
  • OPM has created an internet portal for Postal Service Health Benefit Plan enrollees to use to compare plans and select a plan. Every PSHBP enrollee should have received a letter about this process. The OPM website explains
    • “Thank you for your interest in the Postal Service Health Benefits Program!
    • “Open Season begins on November 11. To get coverage, please visit
    • “https://health-benefits.opm.gov. You can also call the PSHB Helpline at 844-451-1261.
    • “If you have technical issues with your Login.gov account, Login.gov operates a 24/7 contact center via phone or website contact form. Please visit login.gov/contact for more information.”
  • For those unfamiliar with login,gov, it’s an identity verification tool that the federal government uses with all Americans, not just PSHBP enrollees, to access IRS and Social Security portals as well as the PSHBP enrollment portal.
  • Here is a link to OPM’s public use files for FEHBP, PSHBP, and FEDVIP.
  • Kiplinger offers a better 2025 Medicare Parts B and D IRMAA chart compared to the ones in Friday’s CMS fact sheets plus more background on IRMAA.

From the public health and medical research front

  • Per Medscape
    • “Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 
    • “However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide-1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 
    • “In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said.” 
  • and
    • “Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.
    • “The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.
    • “In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.”

From the U.S. healthcare business front,

  • Altarum recently posted a report on trends in healthcare spending at the U.S. state level, including D.C. from 2019 through 2022.
  • Kaufmann Hall tells us,
    • After hearing reports from health systems about decreasing revenue capture from Medicare Advantage (MA) plans, this graphic dives into some of the trends driving this costly challenge providers are facing. MA plans’ popularity has swelled in recent years as seniors are drawn to the extra benefits and lower out-of-pocket costs. As a result, MA enrollees as a share of total inpatient days roughly doubled across all area types between 2015 and 2022. This trend has likely continued as MA penetration has only grown since 2022. This shift has been tough for providers because most MA plans require prior authorization for certain kinds of care, a burnout-driving and costly administrative demand for providers. Although the number of prior authorizations per MA enrollee has remained stable over recent years, providers are seeing more MA patients, leading to an increased burden. On top of that, the overall prior authorization denial rate jumped to 7.4% in 2022, after hovering around 5.7% for several years prior. These decisions can be overturned, but patients and providers often don’t file appeals, leading to higher rates of uncompensated care and lost revenues for providers. Unfortunately, these higher costs have brought many providers to a breaking point in contract negotiations with MA plans, leading to care disruptions that ultimately hurt patients the most.
  • Bloomberg Law reports,
    • “CVS Pharmacy Inc. and the former president of Cigna Corp.’s Express Scripts asked a federal judge to amend an injunction prohibiting her from joining CVS so that it expires at the same time as her noncompete agreement with Cigna.
    • “CVS notified Amy Bricker on Nov. 6 that it’s terminating her inactive employment status with the company, according to a motion the two filed Thursday in the US District Court for the Eastern District of Missouri. CVS and Bricker argued that fact materially changes the circumstances of the injunction because she “will not, even in the future, perform any active employment duties or responsibilities for CVS.
    • “Bricker’s termination followed a Nov. 6 quarterly earnings call where CVS publicly announced senior leadership changes.
    • “It “obviates any need” for the injunction, CVS and Bricker said, and “has the practical effect of interfering with Ms. Bricker engaging in gainful employment for longer than” the Cigna noncompete, which is set to expire Feb. 3.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Susie Wiles, who led Donald Trump’s presidential run, will become his White House chief of staff when he retakes the presidency next year, the campaign said Thursday, making her the first woman to hold that role in U.S. history. * * *”
    • “Those who have worked with her say she is unflappable behind her trademark mirrored sunglasses, avoids the limelight and is quick to give her team credit for her stack of victories.
    • “Every campaign she’s been involved with, she’s been a calming presence,” longtime Florida lobbyist and Wiles ally Brian Ballard told the Journal. “He saw in her the DNA of a winner.”
  • Federal News Network interviews principal Thiago Glieger, a principal of RMG Advisors about getting organized for the Federal Employee Benefits Open Season, which starts next Monday.
  • The Wall Street Journal reports,
    • “U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves. 
    • “The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn’t work at relieving stuffy noses.
    • “The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and no longer sell them. 
    • “After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them. 
    • “The earliest a potential ban would take effect is 2026.
    • “Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.”
  • Beckers Hospital Review adds,
    • “The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration during general anesthesia or deep sedation, Medscape reported Nov. 6. 
    • “The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) released the 2021–2023 Progress Report – PDF for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report provides a high-level overview of progress on select federal agency programs, policies, research, and other activities during fiscal years 2021–2023.”
    • “The progress report features an at-a-glance table of the status of seven core indicators and seven disparities indicators, which were identified in the national plan as a quantitative approach to measuring progress on STI prevention and care in the United States. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets. Of this latter group, six indicators relate to syphilis, which is the focus of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health, Admiral Rachel Levine, M.D.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 16% of American adults — that’s close to 1 in 6 — now has diabetes, according to the latest data from the U.S. Centers for Disease Control and Prevention.
    • “Increasing age and widening waistlines greatly increase the odds for the disease, which happens when the body doesn’t use insulin properly, resulting in high blood sugar levels. If left unchecked, diabetes can be disabling and even life-threatening.
    • “The vast majority (95%) of diabetes cases are type 2 diabetes, which occurs when the body’s cells no longer respond to insulin as they should. Insulin regulates levels of sugar in the blood. Type 2 diabetes is strongly connected to excessive weight. 
    • “The new data, collected from mid-2021 through mid-2023, found a big rise in diabetes rates since 1999-2000, when 9.7% of adult Americans had the disease.
    • ‘There was a significant gender gap in diabetes rates in 2023: Nearly 1 in 5 men (18%) have the illness, compared to 13.7% of women, according to researchers at the CDC’s National Center for Health Statistics (NCHS).”
  • and
    • “A simple nasal swab might help doctors predict the severity of a person’s COVID infection, a new study suggests.
    • “More than 70% of people with mild or moderate COVID develop certain antibodies in their nasal cavities that are linked to fewer symptoms, better immune response and faster recovery, researchers reported Nov. 6 in the journal Science Translational Medicine. * * *
    • “Researchers are working on a nasal swab test that could be used to predict how bad a person’s COVID infection will prove to be.
    • “Right now, we’re either looking at infection risk before it happens or analyzing the infection course well after recovery,” said researcher Ben Babcock, a doctoral candidate at Emory. “Imagine if we could capture the immune response in real time, right in the clinic. A just-in-time test could give physicians and patients the real-time information they need to make faster, smarter treatment decisions.”
  • STAT News informs us,
    • “For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed?
    • “Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the virus might be spreading. Now, long-awaited results from blood testing conducted by the Centers for Disease Control and Prevention are starting to fill in the picture.
    • “The findings, published Thursday, suggest that a small but not insignificant number of H5N1 infections are going undetected among people who work with dairy cows. Blood samples taken from 115 farm workers in Michigan and Colorado over the summer found evidence of a recent infection in eight individuals — half of whom recalled being ill around the same time the cows were sick. The other half could not recall having any symptoms.
    • “Known as serological surveys, the studies involve fishing out antibodies in the blood — molecules made by the immune system in response to a pathogen’s attack that persist long after an infection is over. Finding them is a signal of past contact with a particular virus and helps scientists understand how widely it has spread. 
    • “While the new results suggest that current public health efforts are missing cases, they do not indicate that the strain of H5N1 associated with the dairy cattle outbreak has gained the ability to spread from person to person.”  
  • NBC News reports,
    • “Brie and camembert that may potentially be contaminated with listeria are being recalled, the latest in a series of food incidents in the U.S. in recent months.
    • “Savencia Cheese USA is recalling select soft ripened cheeses after routine testing found the processing equipment at the company’s Lena, Illinois, manufacturing facility may have been contaminated with the bacteria.
    • “Aldi and Market Basket, a supermarket chain in New England, are among stores that sell the cheeses, but the recalled products only had “limited regional distribution” in the U.S., according to the U.S. Food and Drug Administration. 
    • “The “few retailers” that received them have been informed of the possible contamination and are removing products from shelves, the FDA added.
    • “There are no confirmed reports of anyone getting sick so far, the agency noted.”
  • NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Digestion involves much more than just your stomach. The digestive process that fuels your body begins in your mouth each time you take a bite of food and chew. An enzyme in your saliva, called amylase, then starts to break down complex carbohydrates—or starches found in many fruits, vegetables, and grains—into simpler sugars to give you their sweet flavor followed by a burst of energy.
    • “Amylase is the reason we’re so good at turning starch into calories, but it isn’t the same for everyone. There’s plenty of genetic variation in the number of salivary amylase genes (AMY1) our cells carry and, therefore, in how much of this essential starch-busting enzyme people have. Studies have suggested a link between changes in amylase gene copy numbers over time and both the rise of agriculture and starch-heavy diets. Now a study in Science , supported in part by NIH, suggests that extra copies of AMY1 are not only connected to our ability to effectively digest carbs, but also may be more ancient than previously known, arising even before modern humans split from Neanderthals and long before the advent of farming.” * * *
    • ‘The researchers compared the modern-day amylase genes to publicly available DNA sequences from 68 ancient human samples obtained from preserved remains. This revealed that ancient hunter-gatherers already had six to eight AMY1 copies long before people started growing crops and eating high amounts of starch. In fact, genetic variation underlying the production of this enzyme had already spread across Eurasia as far back as 45,000 years ago. However, the new analyses do show an increase in amylase gene copy numbers in the last 4,000 years, as people took up farming.
    • “The study team went on to uncover evidence that the expansion of amylase genes apparently has a longer history than anyone had suspected. Intriguingly, they found three copies of AMY1 in the DNA of three of six Neanderthals and one Denisovan. Neanderthals and Denisovans are both extinct relatives of early humans. The findings suggest that an extra copy of the amylase gene may have arisen as long as 800,000 years ago. The researchers also described how those first extra AMY1 copies could lead to their continued duplications or deletions to produce the wide variation in amylase gene copy numbers seen among modern humans.
    • “This variation in amylase genes would have afforded our ancestors dietary flexibility, allowing them to adapt as diets changed over time. But these discoveries aren’t only fascinating from an evolutionary or historical point of view. They may also lead to new understandings of genetic differences among people today, with potentially important implications for our metabolisms, nutrition, and health.”
  • The Washington Post reports,
    • “Regular practice of yoga can reduce lower-back pain, improve sleep and lessen reliance on pain medication, according to a study conducted by Cleveland Clinic researchers.
    • “The randomized clinical trial studied 140 Cleveland Clinic employees who had disclosed moderate amounts of pain for at least three months. Participants who engaged in a 12-week virtual yoga program reported feeling less pain and better sleep when compared with those who did not have access to the program.”

From the U.S. healthcare business front,

  • Modern Healthcare lets us know,
    • “Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services.
    • “State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company’s latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year.”
  • The American Hospital Association News relates,
    • “Baxter expects to restart a second IV solutions manufacturing line within the next week, the company announced Nov. 7. Along with the first line that resumed production last week, the two lines comprise approximately 50% of the North Cove, N.C., site’s total pre-Hurricane Helene production of IV solutions and about 85% of one-liter solutions production. Hospitals in clinics most commonly use the one-liter solutions. The earliest the facility could begin shipments is late this month.
    • “The company said they expect their peritoneal dialysis and irrigation solutions lines to be the next to resume production and would begin by early December. Baxter expects all lines to restart by the end of the year but does not have a timeline on when total production will return to pre-hurricane levels. The company also said today that it has evaluated and approved more than 200 allocation exception requests to support the neonatal and pediatric patient needs.
    • “In addition, Baxter announced that a second temporary bridge has been installed at the plant and is in use. The bridge will allow traffic for additional trucks and equipment. The first bridge so far has allowed transport of more than 1,000 truckloads of products, Baxter said. Prior to the hurricane, the plant had manufactured approximately 60% — or 1.5 million bags or 95 truckloads — of IV solution used every day in the U.S.”
  • Beckers Payer Issues ranks the largest payers by 3rd quarter profits.
  • Per Fierce Healthcare,
    • “CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending.
    • “Called Intelligent Specialty Engine, the tool leans on Waltz’s capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor.
    • “The PBM said that the platform is a “unique deployment” of Waltz Health’s Waltz Connect platform, which connects users to a network of both national and regional pharmacies that compete on price. It uses AI to help steer patients to “the most cost-effective and clinically appropriate pharmacies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease.
    • “The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and the “evolving landscape of Duchenne” with the approval of Sarepta’s gene therapy Elevidys all played a role, Chief Scientific Officer Louise Rodino-Klapac told analysts and investors.
    • “Elevidys revenue climbed to $181 million in the third quarter from $122 million in the second quarter, beating analyst estimates of about $160 million. Sarepta also pulled in $9.5 million in royalties from Roche, which sells the gene therapy outside the U.S.“
  • Per Fierce Pharma,
    • “Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir. 
    • “But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
    • “Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
    • “Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.”
  • Per MedTech Dive,
    • “Johnson & Johnson received Food and Drug Administration approvalfor its Varipulse pulsed field ablation (PFA) system, joining Boston Scientific and Medtronic in the U.S. market for the fast-growing atrial fibrillation (AFib) treatment.
    • “Varipulse is approved to treat patients with drug-resistant, recurrent paroxysmal AFib, a common form of abnormal rhythm in the heart’s upper chambers, the company said Thursday. The platform is integrated with J&J’s Carto 3 mapping system in a single device that enables electrophysiologists to view inside the heart to position the catheter. 
    • “We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow,” Jasmina Brooks, president of electrophysiology at J&J Medtech, said in a statement.”