Thursday report

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

From Washington, DC,

  • Per a Congressional news release,
    • “[Yesterday,] the House Appropriations Committee met to consider the Fiscal Year 2026 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 35 to 28.”
    •  Among other provisions, the bill “prohibits the Federal Employees Health Benefit Program from covering puberty blockers, hormone therapy, or surgical procedures for gender affirming care.”
  • Healthcare Dive notes,
    • “At a House subcommittee hearing on Wednesday, lawmakers expressed concerns about whether artificial intelligence is being appropriately used in healthcare and called for stronger guardrails to supervise the quickly evolving technology.
    • “With all these innovative advancements being leveraged across the American healthcare ecosystem, it is paramount that we ensure proper oversight is being applied, because the application of AI and machine learning will only increase,” said Energy and Commerce subcommittee Chair, Rep. Morgan Griffith, R-Va.”
  • The Wall Street Journal reports,
    • “Health Secretary Kennedy faced bipartisan Senate [Finance Committee] questioning regarding CDC turmoil and changes to U.S. vaccine policy.
    • “Kennedy defended his actions as necessary to restore the CDC, while critics raised concerns about vaccine access and his appointees.
    • “The CDC is facing internal strife after the ouster of its director and calls for Kennedy’s resignation from employees.”
  • MedPage Today adds,
    • “HHS Secretary Robert F. Kennedy Jr. has chosen seven new members for the CDC’s Advisory Committee on Immunization Practices (ACIP), according to information obtained by MedPage Today‘s editor-in-chief Jeremy Faust, MD.
    • ACIP’s next meeting is set to take place Sept. 18-19, and the posted agenda states that “recommendation votes may be scheduled” for immunizations against hepatitis B, COVID, and respiratory syncytial virus, as well as the measles, mumps, rubella, and varicella shot.
  • STAT News tells us,
    • “After months of uncertainty, the Trump administration confirmed that it will work with Gilead Sciences and The Global Fund to Fight AIDS, Tuberculosis and Malaria to provide a groundbreaking HIV prevention drug to up to 2 million people in low- and middle-income countries.
    • “The ambitious effort was first announced late last year but doubts quickly emerged after the Trump administration began to drastically cut foreign aid. The move appeared to jeopardize the future of the President’s Emergency Plan for AIDS Relief, or PEPFAR, which has long been the world’s leading provider of HIV prevention drugs. Only about half of its $6 billion budget has reportedly been appropriated.
    • “Nonetheless, The Global Fund, which pools money from public and private donors, maintained it would proceed with plans to purchase and distribute the Gilead medication, called lenacapavir. The antiviral offers virtually complete protection against contracting HIV with just a single administration every six months and has been hailed as a tool that could bring the 45-year-old pandemic to heel.” 
  • and
    • “A key government study about alcohol and its health harms will not be released publicly, despite several years of taxpayer-funded work and a growing body of evidence connecting drinking with disease. 
    • “A final version of the Alcohol Intake and Health Study led by the Substance Abuse and Mental Health Services Administration will not be published, “to the detriment of the people’s health,” scientific review panelist Priscilla Martinez told STAT in an email Thursday morning. Another panel member confirmed that they have not heard from the Trump administration since submitting their work months ago. News of the killed report was first reported by Vox.”
  • The American Hospital News informs us,
    • “The Department of Health and Human Services Sept. 4 announced new hardship exemption guidance that would allow consumers ineligible for premium tax credits or cost-sharing reductions to enroll in catastrophic health coverage. Consumer eligibility will be based on projected annual household income. The Centers for Medicare & Medicaid Services made this change in light of the significant anticipated rise in individual market premiums and the expiration of the enhanced premium tax credits at the end of the year.”
  • Modern Healthcare relates,
    • “The Federal Trade Commission asked the public to weigh in on noncompete contract provisions, even though district courts have blocked the commission’s nationwide ban on most of those agreements. 
    • “The agency issued a request for information Thursday, seeking detail about employers who unfairly restrict employees from working for a rival organization through noncompetes. These agreements can stunt wage growth, limit competition, reduce innovation and inflate prices, the FTC said.
    • The commission said the consequences are magnified in healthcare where noncompete agreements can restrict patient access, particularly in rural areas. The comment period will close Nov. 3. 
  • Axios interviews OPM Director Scott Kupor.
    • Q “You’re nominated in December but not confirmed until July. In the meantime, Elon Musk and DOGE make lots of major personnel decisions via OPM. Were you just sitting on your hands?
    • A “The short answer is yes. That’s the rules. I wasn’t even allowed to go into the building, so I was just trying to interpret what was happening. The only time I got more insight was when I started prepping for the Senate confirmation hearing, because I got briefed so I wouldn’t look like a complete idiot.” * * *
    • Q You’ve also talked about establishing more of a merit-based system for federal workers. But DOGE often fired probationary workers, not because of merit but because of where they were on the totem poll.
    • A “It was only around 5,800 probationary employees out of 2.4 million across the entire government. Yes, I’m sure many of those were under 30, and the government has a real problem getting younger workers — only 7% under 30 compared to 24% in the normal workforce — but you still need to view it in context.”
    • Q Of that 2.4 million, how many do you want still working for the government at year-end?
    • A “Around 2.1 million, which is where we were when the first Trump administration took office … That doesn’t include the military, which OPM isn’t responsible for.”
  • FedSmith points out,
    • “The percentage of federal employees working on site has more than tripled from its low point of the last three years according to new data released by Gallup.
    • “The new Gallup poll data show that as of the second quarter of 2025, 46% of federal employees in Washington, DC now work fully on site. This is more than double the national average of 21% and more than triple the low point of 14% back in Q1 2022.
    • “Also, the percentage of federal employees working in a hybrid model (employees who work both on-site and remotely) dropped sharply since President Trump took office, going from 61% at the end of 2024 to 28% in Q2 2025.”
  • At long last, the Spring 2025 semi-annual regulatory and deregulatory agenda has appeared on reginfo.gov.
    • OPM agenda has one FEHB entry reading
      • “The Office of Personnel Management (OPM) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that would have amended the Federal Employees Health Benefits (FEHB) regulations at 5 CFR part 890 that would have allowed FEHB coverage to take effect at the beginning of the pay period that an employee in pay status has an initial opportunity to enroll. OPM is withdrawing the proposed rule as additional research determined that the potential costs to agencies for making updates to business systems and processes for an additional two weeks of FEHB coverage is not an effective use of resources.” 

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday. 
    • “The Food and Drug Administration authorization positions Kardium, which raised $250 million to fund commercialization in July, to launch the system as a treatment for atrial fibrillation.
    • “Kardium is entering a fast-growing market served by Boston Scientific, Johnson & Johnson and Medtronic. The company cited Boston Scientific and Medtronic devices as 510(k) predicates.”

From the public health and medical/Rx research front,

  • The New York Times fills us in about flu shots this fall.
  • Health Day reports,
    • “A single dose of RSV vaccine might protect seniors for two cold and flu seasons in a row, a new study says.
    • “Vaccination reduced seniors’ risk of hospitalization by 58% during two RSV seasons, researchers reported Aug. 30 in the Journal of the American Medical Association.
    • “These results clearly demonstrate that the RSV vaccines prevent hospitalizations and critical illness due to RSV infection among older Americans,” said principal investigator Dr. Wesley Self, senior vice president for clinical research at Vanderbilt University Medical Center in Nashville, Tennessee. “It is exciting to see the public health benefits of this new vaccination program.”
    • “However, the vaccine’s effectiveness waned between the first and second years, raising questions regarding how often seniors should get the jab.” * * *
    • “Redosing the vaccine at some interval after the initial dose could be a strategy to maintain protection over longer periods of time,” Self said. “It will be important to continue to closely monitor vaccine effectiveness over time to understand how long the benefit lasts after a single dose and if repeat dosing should be considered.”
  • Per Tech Target,
    • “One in six women have missed a routine cancer screening in the past year, underscoring deep care gaps imperiling health outcomes, according to new data obtained via email.
    • “The data, gleaned from the full dataset from the Prevent Cancer Foundation’s annual Early Detection Survey, showed that women tend to stay up to date on other ordinary tasks — like getting a haircut, renewing their driver’s license or donating their old clothes — more than their preventive cancer screenings.
    • “Instead, women mostly only schedule a preventive screening when they are experiencing the signs or symptoms of disease, with 33% of respondents saying as much.
    • “Early detection equals better outcomes, so we can’t wait until our bodies are screaming at us to check our health. Women need to prioritize their own health by going to the doctor even when everything feels fine,” Jody Hoyos, CEO of the Prevent Cancer Foundation, said in an emailed statement. “Routine checks and screenings provide an opportunity to stay ahead of cancer, so if there is an issue, you can deal with it before it becomes a bigger problem down the road.”
  • Per STAT News,
    • “One of the worst places for cancer can spread is the leptomeninges, the inner membranes encasing the brain and spine. Patients with these metastases have limited treatment options and tend to succumb to the disease rapidly. But a new study suggests that using proton beam therapy might make it possible to more effectively treat these cancers with radiation and dramatically extend survival.
    • “There’s so little we have to offer patients with leptomeningeal metastasis that really, truly works,” said Lauren Boreta, a radiation oncologist at the University of California San Francisco, who did not work on the study. Treatments that increase survival, the way this study showed proton beam radiation did, is “unheard of for these patients,” she said. “It’s shocking. We haven’t had an advance in this space for maybe ever.” * * *
  • The Washington Post explains “the health risks from plastics almost nobody knows about Phthalates, chemicals found in plastics, are linked to an array of problems, especially in pregnancy.”
  • Per MedTech Dive,
    • “Cardiologists are welcoming the arrival of a new device-based hypertension treatment called renal denervation and asking Medicare to cover the procedure for a large patient population.
    • “Doctors, medical groups and others have endorsed national reimbursement for renal denervation in dozens of public comments submitted to the Centers for Medicare and Medicaid Services ahead of a final Medicare coverage decision expected by early October. Many cite concern about the high numbers of patients whose blood pressure remains poorly controlled despite the availability of multiple drug treatments.” 
  • Genetic Engineering and Biotechnology News reports.
    • “A key to understanding the brain lies in unpacking how hundreds of interconnected brain areas process information that leads to various outputs. In order to try to understand this, researchers investigate both single neurons and groups of neurons together. Now, a major advance in this area of neuroscience study has been published: the first complete activity map of the brain has been unveiled by a large international collaboration of neuroscientists.
    • “Two papers published in Nature reveal insights into how decision-making unfolds across the entire brain in mice at the resolution of single cells. This brain-wide activity map shows that decision-making is distributed across many regions in a highly coordinated way.”
    • “This is the first time anyone has produced a full, brain-wide map of the activity of single neurons during decision-making,” explained Professor Alexandre Pouget, PhD, co-founder of the International Brain Laboratory (IBL) and group leader at the University of Geneva. “The scale is unprecedented as we recorded from over half a million neurons across mice in 12 labs, covering 279 brain areas, which together represent 95% of the mouse brain volume. The decision-making activity, and particularly reward, lit up the brain like a Christmas tree.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Employees of large and small companies are likely to face higher health care costs, with increases in premiums, bigger deductibles or co-pays, and will possibly lose some benefits next year, according to a large survey of companies nationwide that was released on Thursday.
    • “The survey of 1,700 companies, conducted by Mercer, a benefits consultant, indicated that employers are anticipating the sharpest increases in medical costs in about 15 years. Higher drug costs, rising hospital prices and greater demand for care are all contributing factors, experts said.
    • “With the projected increases, this is the fourth consecutive year in which employers — and their workers — have faced significantly higher costs for health insurance, with next year representing the biggest jump since 2010.” * * *
    • “Without making any changes to benefits — which would involve moves like shifting more costs to workers or reducing benefits — employers said they expected next year’s increases in health costs to reach nearly 9 percent on average. By altering plans, they projected increases overall of 6.5 percent on average in health costs next year.
    • “A quarter of those surveyed projected double-digit increases for 2026 even after changes to plans.”
  • Modern Healthcare relates,
    • “Elevance Health will cut some Medicare Advantage plans and fully exit the Medicare Part D standalone prescription drug market next year. 
    • “The for-profit Blue Cross and Blue Shield licensee will eliminate unprofitable Medicare Advantage plans covering approximately 150,000 individual and group members in total, Chief Financial Officer Mark Kaye said Thursday during the 2025 Wells Fargo Healthcare Conference. The company has prioritized HMO and Dual Special Needs Plan coverage for 2026, he said.
    • “Elevance Health is the fourth-largest Medicare Advantage carrier, with 2.3 million enrollees. It counts 400,000 standalone Part D members, making it the sixth-largest carrier, according to a July report by KFF, a healthcare research firm. It is one of seven companies that sell standalone Part D plans, KFF said. Fee-for-service Medicare beneficiaries purchase the coverage to help offset their prescription drug costs.” 
  • Beckers Payer Issues adds,
    • “UCare has asked CMS to mutually terminate its Medicare Advantage plans for 2026, citing rising medical costs and challenges within the broader market.
    • “This decision was not made lightly,” President and CEO Hilary Marden-Resnik said Sept. 4 “UCare remains deeply committed to the health of Minnesotans and to supporting members through upcoming transitions.”
    • “UCare has more than 600,000 members in Minnesota and parts of western Wisconsin, including 158,000 MA members. It is the second largest MA carrier in the market, with 26% percent market share. The company will continue to offer Medicaid, special needs plans, Medicare supplement and ACA coverage.”