Midweek update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The U.S. Office of Personnel Management has posted a bio of its new Director Scott Kupor.
  • USA Today reports,
    • “President Donald Trump signed a law that extends tougher prison sentences for fentanyl trafficking, surrounded by relatives of people who died from overdoses and lawmakers who approved the bill.
    • “Today we strike a righteous blow to the drug dealers, narcotic traffickers and criminal cartels,” Trump said. “We take a historic step toward justice for every family touched by the fentanyl scourge.”
    • “The law places fentanyl on the Drug Enforcement Administration’s list of most serious drugs with no accepted medical use and a high potential for abuse. The list includes drugs such as heroin, cocaine and LSD. Fentanyl has been temporarily assigned to the Schedule 1 category since 2018. The law makes the designation permanent.
    • “The law also makes permanent mandatory minimum penalties of five years in prison for trafficking 10 grams of fentanyl and 10 years for 100 grams.”
  • Per a Senate news release,
    • “Sens. Chuck Grassley (R-Iowa) and Maggie Hassan (D-N.H.) reintroduced the Healthy Moms and Babies Act to improve maternal and child health care across the nation. The maternal health crisis in the United States particularly affects those living in rural America and women of color. Grassley previously chaired the Senate Finance Committee and continues to serve as a committee member, alongside Hassan.
    • “The legislation builds on Grassley and Hassan’s longstanding efforts to improve maternal and child health by delivering high-quality coordinated care, supporting women and babies with 21st century technology and taking other steps to reduce maternal mortality.” * * *
    • “Additional information on the Grassley-Hassan Healthy Moms and Babies Act is available below:
  • STAT News informs us,
    • “Doctors for decades have been paid using rates developed largely under the advice of the industry’s main lobbying group, the American Medical Association. Experts have railed against the system for decades, calling it complex and filled with self-interested factions that ultimately favor surgeons and higher-priced specialists over primary care clinicians. 
    • “Medicare’s proposal for 2026 would create a so-called “efficiency adjustment” that would reduce payment by 2.5% for thousands of procedures and diminish some of the influence held by the AMA’s advisers, known as the Relative Value Scale Update Committee, or the RUC. 
    • “This is probably one of the most controversial components of this rule,” said Shari Erickson, a top official with the American College of Physicians, which mostly lobbies for primary care doctors. “It is sort of continuing to chip away at some of the concerns that many have raised about the RUC and the power that they’re viewed as having.”
    • “The result is that family medicine doctors and other primary care physicians would see the highest average increases in their payments, per Medicare’s estimates. Dermatologists, gastroenterologists, general surgeons, neurosurgeons, ophthalmologists, orthopedic surgeons, pathologists, and radiologists would experience some of the biggest net decreases to their Medicare pay.
    • “Importantly, the agency would exempt services that are based on time — for example, routine 15- and 30-minute visits performed by primary care physicians. More broadly, Medicare is using the savings from these cuts to bump up the “conversion factor” that dictates the payment rates for all physician services.
    • “Michael Abrams, managing partner of health care strategy firm Numerof & Associates, said this would help fix what’s been a “very serious issue” for decades: the pay imbalance between primary and specialty care.” 
  • The Government Accountability Office released a report on comparative clinical effectiveness research this week.
    • “Comparative clinical effectiveness research compares the success and outcomes of available treatment options for various diseases and conditions. Findings from this research can provide important information on more effective treatments. The Department of Health and Human Services shares these research findings with the public and helps to apply the findings in health care settings.
    • “But we found that HHS hasn’t done a thorough evaluation of these activities. Completing an evaluation will help to show if HHS’s efforts are promoting evidence-based care and, ultimately, improving health outcomes.
    • “Our recommendation [to HHS] addresses this issue.”
  • From the judicial front,
    • Fierce Healthcare lets us know,
      • “Blue Cross and Blue Shield of Kansas City has improperly reduced payments for inpatient services in coordination with third-party vendors, a lawsuit from AdventHealth Shawnee Mission Medical Center alleges.
      • “The hospital claims Blue KC uses clinical validation audits to reject medical diagnoses and declare them “invalid” under “secret and dubious criteria,” in violation of state and federal law, the lawsuit (PDF) says. Blue KC, allegedly, has not paid more than $2 million owed to the AdventHealth hospital after invalidating more than 350 medical diagnoses.
      • “At the crux of the plaintiff’s argument is Blue KC’s relationship with third-party care platforms for providers and payers. The health system has never approved of Blue KC’s relationship with vendors performing clinical validation audits, yet AI technology can supplant a physician’s opinion. Vendors used by Blue KC have publicly touted its AI technology in the past.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products and other foods.
    • “Today’s actions are the first results from the agency’s ongoing analysis of its portfolio of over 250 food Standards of Identity (SOI) to make sure they are useful, relevant and serve consumers in the best possible way. The removal of these standards is in alignment with broader efforts to ensure that HHS is directing resources to where they’re most needed – delivering better outcomes for the American people.”
  • Per Fierce Pharma,
    • “The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD).
    • “For an upcoming meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, the agency is asking an expert panel to weigh in on whether results from an exploratory phase 2 trial and a positive phase 3 study can overcome negative findings from a second phase 3 of the combination.
    • “Discordant results” from the two phase 3 trials have FDA reviewers worried, especially since the agency said it was unable to identify an explanation for the differing outcomes despite “extensive exploratory analyses.”

From the public health and medical research front,

  • Health Day tells us,
    • “Folks using GLP-1 weight loss drugs like Ozempic are more likely to suffer from severe acid reflux, a new study says.
    • “People with type 2 diabetes were more likely to suffer from gastroesophageal reflux disease (GERD) if they were prescribed a GLP-1 drug compared to those taking sodium-glucose cotransporter-2 (SGLT-2) inhibitors, researchers reported today in the Annals of Internal Medicine.
    • “We estimated that most GLP-1 (drugs) increased risk for GERD,” concluded the research team led by Laurent Azoulay, an associate professor with the Jewish General Hospital’s Center for Clinical Epidemiology in Montreal, Canada.
    • “The risk for serious GERD-related complications was higher among smokers, people with obesity and folks with existing stomach problems, researchers said.
    • “Although our findings need to be corroborated in other studies, clinicians and patients should be aware of a possible adverse effect of GLP-1 (drugs) on GERD,” researchers noted.”
  • BioPharma Dive reports,
    • “In experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3 trial in China, positioning the companies to seek approval there and to begin global late-stage testing.
    • “The drug, a once-weekly injection dubbed HRS9531, spurred about 18% weight loss in treated participants after 48 weeks, roughly 16% more than those given a placebo. Nearly 9 in 10 people given HRS9531 lost at least 5% of their body weight and over 44% achieved at least 20% weight loss, the companies said Tuesday.
    • “Hengrui and Kailera didn’t disclose specific safety data, only noting that most treatment-emergent adverse events were mild to moderate and gastrointestinal-related. Detailed results will be presented at a future medical meeting. Hengrui will file an approval application in China, while Kailera will initiate global studies that involve higher doses and a longer treatment duration, the startup’s CEO, veteran executive Ron Renaud, said in the statement.”
  • Cardiovascular Business relates,
    • “Vitamin D supplements can help patients reduce their risk of developing cardiovascular disease (CVD), according to a new analysis in Nutrients.[1] In fact, the team behind the new study argued that prior research finding no connection between vitamin D and CVD was flawed.  
    • “The global prevalence of CVD for 2025 was estimated at 598 million, and global CVD deaths at 20.5 million,” wrote first author William B. Grant, PhD, with the Sunlight, Nutrition, and Health Research Center in San Francisco. “Thus, finding ways to reduce the risk of CVD is warranted. There has been a long-standing debate regarding the role of vitamin D in reducing the risk of CVD.”
    • “Grant et al. did note that many randomized controlled trials (RCTs) have found that vitamin supplements fail to reduce cardiovascular risks when compared to a placebo. However, the team added, several other kinds of stories have told another story—and there is a reason for this difference.
    • “RCTs are used for medications to evaluate the use of drugs to prevent and treat diseases,” they wrote. “These drugs are not found in nature, whereas vitamin D is. Additionally, pharmacological agents have narrow dose–response curves. In contrast, nutrients are threshold agents and have broader and often S-shaped dose–response curves.”
  • and
    • “A new-look polymer heart valve is associated with encouraging one-year outcomes in patients undergoing surgical mitral valve replacement (SMVR), according to new data presented at New York Valves 2025 and published in the Journal of the American College of Cardiology.[1]
    • “The Tria mitral valve from Utah-based Foldax is built using LifePolymer, a proprietary material that does not include any animal tissue. Both the frame of the valve and its leaflets are robotically generated to match the patient’s native mitral valve.
    • “The valve made headlines in early June when it was approved for commercial use in India. This represented the first time a polymer heart valve had ever gained such an approval anywhere in the world.”
  • Per a National Institutes of Health press release,
    • “A scientific team supported in part by the National Institutes of Health (NIH) has developed a new, ultra-high-resolution brain imaging system that can reconstruct microscopic brain structures that are disrupted in neurological and neuropsychiatric brain disorders. The new system is a significant advance over conventional magnetic resonance imaging (MRI) scanners that cannot visualize these tiny but clinically important structures.
    • “The system, called the Connectome 2.0 human MRI scanner, overcomes a significant hurdle for neuroscientists: being able to bridge different brain regions and probe tiny structures necessary to define the “connectome,” the complex matrix of structural connections between nodes in the nervous system, and to do it noninvasively in living humans.
    • “This research is a transformative leap in brain imaging – pushing the boundaries of what we can see and understand about the living human brain at a cellular level,” said John Ngai, Ph.D., Director of NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “The new scanner lays essential groundwork for the BRAIN CONNECTSprogram’s ultimate goal of developing a wiring diagram for the human brain.”
    • “The scanner is innovative in two major ways: it fits snugly around the heads of living people, and it has many more channels than typical MRI systems. These advances greatly increase the signal-to-noise ratio of the system, providing much sharper images of very small biological brain structures than previously possible. These technical upgrades will enable scientists to map human brain fibers and cellular architecture down to nearly single-micron precision to study how subtle changes in cells and connections relate to cognition, behavior, and disease.”
  • Per a National Institute of Standards and Technology news release,
    • “In an effort to foster progress in cancer research, the National Institute of Standards and Technology (NIST) is releasing detailed and comprehensive data about the entire genetic content of a pancreatic cancer cell. Scientists can use it to research tumors, improve cancer diagnostic tests, and develop new cancer treatments.
    • “The NIST data on this cancer genome — that is, the full set of genetic instructions from the cell, including the mutations that caused the disease — is several terabytes in size. The genome came from a 61-year-old pancreatic cancer patient who explicitly consented to making the genetic code of her cancer cells publicly available for research and clinical use.”
  • Per STAT News,
    • “One in five individuals who receive a kidney transplant experience a rejection episode within a year. A new approach to donor-recipient matching could help change that.
    • “Mismatches between donors and recipients in SIRP-alpha, an immune cell surface receptor, could contribute to transplant rejection, researchers report in a study published Wednesday in Science Translational Medicine.
    • “What’s groundbreaking about it is that innate immune cells, immune cells that we have not necessarily associated with sensing the graft and attempting to reject it, are now in the center of the rejection battle,” said Fadi Lakkis, a study co-author and professor of nephrology at Stanford University.”
  • and
    • “Ten years ago, U.K. policymakers gave the green light to a pioneering reproductive technology meant to spare children from being born with types of rare but sometimes fatal diseases caused by genetic mutations in the powerplants of cells. The method involved combining not just the genes of a mother and father to produce an embryo, but a bit of DNA from a third person as well. 
    • “On Wednesday, the team in England that has been performing the technique reported that eight healthy babies have been born so far, highlighting that the approach reduced the risk of children inheriting disease-causing mutations in the pieces of DNA contained in our mitochondria. The results, published in a pair of papers in the New England Journal of Medicine, have been long awaited as the first large test of the approach, which is known as mitochondrial replacement therapy or mitochondrial donation. 
    • “All the children are well and continue to meet developmental milestones,” Bobby McFarland, a professor of pediatric mitochondrial medicine at Newcastle University and one of the experts behind the research, told reporters at a press conference in London Wednesday.”
  • and
    • “An oral capsule can efficiently deliver liquid mRNA therapy directly to the gut, a possible new delivery mechanism for mRNA vaccines, a new study finds.
    • “In the study published in Science Translational Medicine on Wednesday, researchers said they successfully used RNACap, a capsule engineered to prevent stomach acids from degrading liquid mRNA therapy to treat inflammatory bowel disease. Once the capsule was in the gut, they used normal stomach contractions to release the mRNA therapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “ChristianaCare and Virtua Health are exploring a potential merger that would yield an eight-hospital nonprofit regional health system spanning 10 New Jersey, Delaware, Pennsylvania and Maryland counties.
    • “The systems have signed a nonbinding letter of intent to explore the deal; they announced Wednesday but did not give a timeline for when the combination could be executed. The resulting entity would have almost 30,000 employees, more than 600 sites of care and over $6 billion in annual revenues.
    • “At a time of great uncertainty in health care, ChristianaCare and Virtua Health have the foresight and courage to explore what is possible,” Janice Nevin, M.D., president and CEO of ChristianaCare, said in the announcement. “We are excited to take this bold step to double down on our mission, multiply our excellence and ensure our legacy of high-quality care in our local communities for generations to come.
    • “Together, we aim to create an integrated regional health system built on human connection, clinical excellence and a deep commitment to all people in the communities we serve,” Virtua Health President and CEO Dennis Pullin said.”
  • BioPharma Dive informs us,
    • “Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical company’s portfolio during a year in which its formerly top-selling drug lost market exclusivity.
    • “Second quarter sales for J&J’s pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher than the same period last year on an operational basis. Overall second quarter sales were up 4.6% on the same basis to total $23.7 billion, beating Wall Street forecasts.
    • “J&J now expects higher operational growth for 2025, increasing the midpoint of its guidance range for both adjusted sales and earnings per share.”
  • MedTech Dive relates,
    • “Quest Diagnostics is planning to offer laboratory testing based on Fujirebio Diagnostics’ recently Food and Drug Administration-authorized Alzheimer’s disease blood test.
    • “In May, Fujirebio’s in vitro diagnostic became the first blood test to aid in the diagnosis of Alzheimer’s cleared by the FDA. Quest, which disclosed its plans for the IVD last week, launched a laboratory-developed test for similar biomarkers in April.
    • “The clinical lab plans to make Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test available for use by physicians and researchers this summer.”
  • KFF issued a report about “The Uncertain Future of “Medicare’s Stand-Alone Prescription Drug Plan Market and Why It Matters.”
    • “Ahead of Medicare’s annual mid-year announcement about the national average premium for Part D prescription drug coverage in 2026 and other plan details, two questions loom large for the insurers that sponsor Part D stand-alone prescription drug plans (PDPs) and the 23 million people in traditional Medicare who are currently enrolled in these plans: Will the Trump administration continue Medicare’s Part D premium stabilization demonstration for a second year, and what will the PDP market look like in 2026 and in subsequent years? The answer to the first question could determine whether monthly PDP premiums remain at a relatively affordable level and whether PDP availability remains stable in 2026. The answer to the second question has larger implications for the viability of traditional Medicare as an option for beneficiaries nationwide but especially for beneficiaries who live in rural areas. This is because rural Medicare beneficiaries are more likely to be enrolled in traditional Medicare and rely more on drug coverage from stand-alone PDPs than Medicare Advantage plans.”
  • The Brown & Brown consulting firm explains why employers and health plans should be paying attention to surgical centers of excellence.
  • Per Fierce Healthcare,
    • “Employers have spent several years taking steps to avoid shifting healthcare costs to workers, but as expenses continue to rise, some firms are looking to change course, a new survey shows.
    • “Analysts at Mercer polled 711 employers (PDF), including large and small firms, and found that 51% said they are either likely or very likely to shift costs to employees for their 2026 plans. That’s up from 45% who said the same for 2025, according to the survey.
    • “Of that group, 19% said they were very likely to shift costs and 33% said they were likely to do so in 2026, the survey found. For 2025, 14% of employers said very likely and 31% said likely.
    • “Employers’ healthcare costs grew 4.5% in 2024 and are expected to increase by an average of 5.8% this year, according to Mercer. That figure accounts for cost-saving measures, but costs could rise by an estimated 8% if employers take no action.”