Midweek Update

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

From Washington, DC

  • Fierce Pharma reports,
    • “The U.S. House of Representatives has given a unanimous thumbs-up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last year.
    • “Rep. Michael McCaul, R-Texas, introduced the legislation in February alongside support from five other Republican Congressmen and five Democrats. The bill now advances to a Senate vote.
    • “By strengthening incentives for pediatric drug development, restoring essential programs such as the FDA Rare Pediatric Disease Priority Review Voucher, and ensuring that life-saving therapies reach the children who need them most, we are making meaningful progress,” Rep. Gus Bilirakis, R-Fla., said in a release.”
  • The Government Accountability Office today published a report titled “Patient Protection and Affordable Care Act:Preliminary Results from Ongoing Review Suggest Fraud Risks in the Advance Premium Tax Credit Persist.”
    • “This report discusses the preliminary results of our work on fraud risk management in the advance premium tax credit—a subsidy that the government pays to insurance companies to make premiums more affordable for eligible Americans under the Affordable Care Act.
    • “So far, we’ve found that fraud risks have persisted since we first reported on this (2014-2016). For example, we were able to get subsidized insurance for fake enrollees. We also found some issues with enrollees’ Social Security numbers that could indicate identity fraud.
    • “The program’s fraud risks were last assessed in 2018, even though the program and its risks have since evolved.”
  • Similarly, on November 24, the U.S. Office of Personnel Management’s Office of Inspector General published a capstone report on the agency’s implementation of the Postal Service Health Benefits Program. One key issue regarding confirmation of dependent eligiblity remains open.
    • The FEHBlog’s internal control concern is that OPM fails to use the HIPAA 820 electronic enrollment roster transaction with FEHB and PSHB carriers. The HIPAA 820 transaction, whihc has been around since 2008, allows carriers to tell whether a particular enrollee is paying a premium and if so is paying the correct premium. Bear in mind that half of the FEHB enrollment is self only. The HIPAA 820 transaction will produces savings that would cover the cost of implementation.
  • FedWeed reminds us,
    • Flexible spending account “participants may carry over part of the account for use in the next year, so long as they have accounts for that following year. For unspent 2025 money carried into 2026, that limit is $660 (for unspent 2026 health care account money eligible to be carried into 2027, the limit will be $680).”
  • and
    • “Next Monday (December 8) is the last day of the current open season to enroll or change coverage for 2026 under the FEHB and PSHB health insurance programs and the FEDVIP vision-dental insurance program, or to newly enroll or re-enroll in the FSAFEDS flexible spending account program.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) today announced the release of a new mandatory training program, “Performance Management for Supervisors,” designed to equip federal supervisors with the essential skills needed to lead high-performing, engaged teams.
    • “The training, now available through the Federal Performance Management Toolkit focuses on an array of topics including employee recognition and awards, hiring and discipline, drafting effective performance goals, delivering meaningful feedback, and taking timely corrective action.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced strong actions to protect the rights of parents within the practice of pediatric medicine. HHS opened an investigation into a complaint that a Midwestern school illegally vaccinated a child with a federally provided vaccine without the parents’ consent by ignoring a religious exemption submitted under a state law. HHS also issued a Dear Colleague letter [PDF, 265 KB] reminding health care providers about federal law requiring them to provide parents access to their children’s health information. In addition, the Department directed the Health Resources and Services Administration (HRSA) to add a grant requirement stating that all funding recipients must comply with all applicable federal and state parental-consent laws for any services or care provided to minors at HRSA-supported health centers as a condition of receiving Health Center Program funds.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services has updated its GitHub repository with new resources to help hospitals comply with changes to hospital price transparency requirements finalized in the Medicare hospital outpatient prospective payment system final rule for calendar year 2026.”
  • STAT News points out,
    • “A new health care advocacy group, which will represent the shrinking number of independent doctors in America, is launching Wednesday with an ambitious policy agenda.
    • “IndeMed, which expects to represent nearly 70,000 members at its launch, will take on a host of issues important to doctors wanting to resist the wave of consolidation in recent years, its leaders told STAT. The group’s agenda includes reducing the burden of prior authorization, promoting transparent and fair reimbursement from payers, encouraging new practice models, fighting consolidation, and reforming the No Surprises Act.
    • “The group, through its nonprofit and associated political action committee, will push for changes in Washington as well as in states, and plans to offer members a state-by-state advocacy playbook.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Former Food and Drug Administration commissioners said new vaccine standardsthreaten to put Americans’ health at risk and upend the agency’s scientific integrity.
    • “The 12 former FDA leaders criticized the agency’s actions under vaccine skeptic Health Secretary Robert F. Kennedy Jr., in a joint piece published by the New England Journal of Medicine Wednesday.
    • “The authors make up nearly all of the living former FDA commissioners and acting commissioners, including Dr. Scott Gottlieb, who served during President Trump’s first term, and Dr. Robert Califf, who helmed the agency during the Obama and Biden administrations. 
    • “The article takes aim at the FDA’s plans for new vaccine standards detailed by vaccine division director Dr. Vinay Prasad that the former leaders said would drastically change vaccine regulation and “undermine public interest.” 
    • “In an email to staff last week, Prasad said the FDA will change its annual flu vaccine framework and require companies to submit larger studies about the effects of administering several vaccines at once.” 
  • STAT News tells us,
    • “Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the Center for Drug Evaluation and Research, according to an announcement from the FDA.
    • “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg said in a statement. “This is an incredible opportunity to serve my fellow Americans.”
    • “Høeg’s appointment as the agency’s top drug regulator comes after director Richard Pazdur filed paperwork to retire at the end of the month.”
  • Healio points out,
    • “The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with spinal muscular atrophy and a confirmed mutation of the survival motor neuron 1 gene, according to the manufacturer.
    • “In a press release, Novartis said the FDA’s approval positions Itvisma (onasemnogene abeparvovec-brve) as the first and only gene replacement therapy available to treat individuals with spinal muscular atrophy (SMA), a rare neuromuscular condition, virtually across the entire lifespan.”
    • “Itvisma is administered with a one-time fixed intrathecal dose that does not require adjustment based on a patient’s age or body weight, per the release. The drug is expected to be available within the U.S. in December.”

From the public health and medical / Rx research front

  • The University of Minnesota’s CIDRAP relates,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 30 more measles cases reported in the United States this past week, raising the national total to 1,828 confirmed cases so far in 2025. 
    • “Current US hot spots are Utah, Arizona, and South Carolina, where outbreaks among predominately unvaccinated or under-vaccinated people have led to community spread and widespread quarantines at schools. 
    • “In total, the country has had 46 outbreaks this year of three or more cases; for comparison, 16 outbreaks were reported during all of 2024.” 
  • Health Day tells us,
    • “As many as 1 in 4 breast cancers occur in women younger than 50, a new study has found.
    • “Among seven outpatient clinics in the New York region, 20% to 24% of breast cancers were found in women 18 to 49, according to results presented Monday at the Radiological Society of North America’s annual meeting in Chicago.
    • “This research shows that a significant proportion of cancers are diagnosed in women under 40, a group for whom there are no screening guidelines at this time,” researcher Dr. Stamatia Destounis, a radiologist with Elizabeth Wende Breast Care (EWBC)  in Rochester, New York, said in a news release.
    • “The U.S. Preventive Services Task Force recommends mammography every other year starting at 40 and continuing through age 74, researchers noted. 
    • “The American Cancer Society recommends annual mammograms starting at age 45, but added that women can choose to begin breast cancer screening as young as 40.”
  • MedPage Today reports,
    • “Vaccination against herpes zoster, or shingles, was tied to fewer deaths among people with dementia, an analysis of data in Wales showed.
    • “Dementia patients who received the live-attenuated zoster vaccine (Zostavax) had a 29.5 percentage point decrease (95% CI 0.6-62.9, P=0.046) in dementia-related deaths over 9 years, reported Pascal Geldsetzer, MD, PhD, of Stanford University in California, at the annual Clinical Trials on Alzheimer’s Diseaseopens in a new tab or window (CTAD) annual meeting. The findings were published simultaneously in Cellopens in a new tab or window.
    • “Zoster vaccination also was tied to a drop of 3.1 percentage points (95% CI 1.0-6.2, P=0.007) in mild cognitive impairment cases during that period, Geldsetzer added.
    • “Our findings suggest that the live-attenuated herpes zoster vaccine has a beneficial effect at both ends of the disease course of dementia,” he said.
    • “They also hint that the shingles vaccine might slow dementia progression, he noted.”
  • BioPharma Dive reports,
    • “Data from a closely watched study evaluating Bristol Myers Squibb’s mind-stabilizing medicine Cobenfy in patients with Alzheimer’s disease could now come a year later than expected.
    • “In late July, Bristol Myers executives said they were reviewing the company’s near-term clinical trials to ensure the “timely delivery” of results with the “highest probability of success.” The review included “ADEPT-2,” a late-stage experiment exploring whether Cobenfy, which is already used to treat schizophrenia, may also have positive effects on the moderate to severe psychosis that often accompanies Alzheimer’s.
    • “On Wednesday, Bristol Myers disclosed that it had identified “irregularities” in the way the study was conducted at a “small number” of sites. This discovery prompted the company to not only exclude patient data from those sites for the study’s primary analysis, but, after consulting with the Food and Drug Administration, also bring in an “independent party” to assess the data that had been collected.
    • “Based on that party’s findings, a data monitoring committee recommended the trial keep going and enroll more participants so as to hit its original target. Bristol Myers is following this advice. ADEPT-2 had recruited around 400 patients across 119 locations, according to its listing on a federal database of clinical trials.
    • “The company now expects results to come by the end of 2026.”
  • and
    • “Pharvaris said Wednesday its pill for the rare swelling disorder hereditary angioedema succeeded in a Phase 3 trial, helping to begin relieving symptoms of an attack within 1.28 hours, significantly faster than a placebo.
    • “The Netherlands-based biotechnology company said it plans on asking the Food and Drug Administration in the first half of 2026 to approve deucrictibant. An extended release formulation of the medication is also in a Phase 3 trial to test whether it can prevent HAE attacks, with data expected next year.
    • “If approved, deucrictibant would be entering an increasingly competitive market. The first oral HAE drug to relieve attacks, Kalvista’s Ekterly, got an FDA nod this year, while two injectable drugs, including one to relieve attacks, also recently launched.”

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

  • Modern Healthcare lets us know,
    • ‘Startup health insurance company Curative has raised more than $150 million in a funding round that pushes the company’s value at about $1.28 billion.
    • “Curative works to address skyrocketing employer health insurance expenses as inflation, pricey drugs and chronic diseases drive up costs.
    • “The company expects 2026 to be its first profitable year since the pandemic, and projects $570 million in revenue for this year.” * * *
    • “Curative’s approach differs from typical insurers. It eliminates cost-sharing like copays and deductibles for care in its network, as long as members complete an annual visit with a primary care provider and a “navigator” who guides their care, said Fred Turner, the company’s co-founder and chief executive.”
  • and
    • “Direct-to-consumer telehealth company Hims & Hers Health said Wednesday it has agreed to acquire YourBio Health, a medical device company that develops blood sampling technology.
    • “Financial terms of the transaction were not disclosed. 
    • “The deal is slated to close early next year pending customary closing conditions, according to a release.” * * *
    • “The acquisition will allow Hims & Hers to add YourBio Health’s TAP device, which uses smaller, thin needles to collect capillary blood samples in a way that differs from traditional methods, into its offerings. 
    • “YourBIO CEO Paul Owen and Chief Scientific Officer Dr. Michael Mina will join Hims upon completion of the deal, the company announced.”
       
  • The American Hospital News tells us,
    • “The AHA Dec. 3 released its 2026 Health Care Workforce Scan — an annual snapshot of America’s hospital and health system employment based on reports, studies and other data sources from leading organizations and researchers. It also offers insights and strategies from peers and experts on navigating the future of the health care workforce.”
  • Beckers Hospital Review identifies five health systems launched this year.
  • Per MedCity News,
    • “Samsung Healthcare unveiled a new ultrasound system this week designed to boost diagnostic accuracy and efficiency. 
    • “The system, named the R20, finally brings the full weight of Samsung Electronics’ AI and semiconductor capacity into an ultrasound platform, said Tracy Bury, chief commercial officer and vice president of global growth initiatives at Samsung Healthcare during an interview Tuesday at the Radiological Society of North America’s annual conference in Chicago.
    • “The R20 system pairs Samsung’s imaging hardware with improved beamforming software, which helps produce sharper, more consistent images, she stated. It supports a wide spectrum of imaging use cases, such as abdomen, thyroid, musculoskeletal, vascular, breast, gynecology and urology.” 
  • “MedTech Dive discusses “PitchBook: AI tuck-in deals to drive M&A acceleration in 2026. Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.”
    • “The medtech industry is approaching 2026 in an improving position, with investors increasingly optimistic and funding rebounding, PitchBook said in its outlook for next year.
    • “PitchBook analysts said strategic investors are targeting companies that are approaching clinical milestones in cardiology, orthopedics and diagnostics. The analysts named neurostimulation, artificial intelligence-powered surgical navigation and precision medicine as other top areas to watch.
    • “Tariffs on China-sourced components are a manageable, persistent headwind, the analysts said, but the potential for more levies is a risk. PitchBook sees Medline’s planned initial public offering as a strong indication that tariff uncertainties are now less top of mind.”

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