Midweek Update

No Surprises Act

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Today, the Government Accountability Office released a report on priority open recommendations made to the U.S. Office of Personnel Management.
    • “In May 2024, GAO identified 16 priority recommendations for the Office of Personnel Management (OPM). Since then, OPM has implemented three of those recommendations.
      • Specifically, OPM took actions to better mitigate cybersecurity risks, improve its payroll database, and strengthen privacy protections for personally identifiable information on its IT systems.
    • In August 2025, GAO identified one additional priority recommendation for OPM, bringing the total number to 14. These recommendations involve the following areas:
      • preventing improper payments,
      • strengthening IT security and management,
      • addressing mission critical skills gaps,
      • improving the federal classification system,
      • making hiring authorities more effective,
      • improving payroll data, and
      • addressing employee misconduct and improving performance management.
    • OPM’s continued attention to these issues could lead to significant improvements in government operations.
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) this week released new data fueling a narrative of rampant broker fraud on the Affordable Care Act (ACA) exchanges.
    • “Plans received data finding 23% of enrollees did not have a claim in 2019. That number jumped sharply to 35% last year.
    • “Before the pandemic, the data were largely consistent across three categories: members on state-based exchanges, members on the federal exchange in Medicaid expansion states and on the federal exchange in non-expansion states. No matter the group, about 22% to 24% of enrollees did not have a claim.
    • “But, by 2024, expansion states on the federal exchange saw an increase from 22% to 32%, and the non-expansion population jumped from 24% to 41% without a claim, according to the agency’s data. Meanwhile, enrollees on state-based exchanges without claims climbed modestly from 22% to 24%.”
  • The suspicion is that brokers have been adding phantom enrollees to highly federal government subsidized silver and bronze plans.
    • The Paragon Health Institute adds,
      • “As Paragon discussed in our The Great Obamacare Enrollment Fraud series, large-scale fraud schemes have led to people enrolling in exchange plans without their knowledge, and others being misled by false offers of cash or gift cards to apply for insurance. A few months ago, a Bloomberg exposé revealed fraud rings in Florida, including brokers earning thousands daily by enrolling people who often had no idea.”
  • An HHS news release features a trip that HHS Secretary Robert F. Kennedy took to Alaska last week to highlight rural and tribal health priorities.
  • Beckers Health IT considers whether the Trump administration can achieve its goal of doing away with clipboards in healthcare. It’s worth pointing out
    • “Curtis Cole, MD, vice president and chief global information officer of Ithaca, N.Y.-based Cornell University, said he’s “hopeful that something positive” will come from the plan, but he’s not “particularly sanguine.”
    • “A lot of it looks like the all-too-frequent use of computers to make bad processes work faster, rather than fixing the fundamental problem,” he said.
    • “He pointed to the lack of a national patient identifier, which other developed nations have. The Trump administration is advocating for digital identity verification to link patients to their records, but Dr. Cole says those systems often have incorrect or incomplete information.”
  • HIPAA, a 1996 federal law, calls for HHS to create a national patient identifier but Congress has blocked funding for that initiative. 
  • STAT News reports,
    • “A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records.
    • “The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a “coalition analyzing the impact of Medicare Drug Price Negotiation on patients.” * * *
    • “The IRA Watchdog is not a stand-alone lobbying organization. It’s housed in the firm DLA Piper, and its two lobbyists were staffers for former Sen. Richard Burr (R-N.C.), who while in Congress championed the biotech sector, a key driver of the economy in his home state. Burr is a senior policy adviser at DLA Piper and the chair of its health policy strategic consulting practice.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections.
    • “Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the first in a new class of drugs called DPP-1 inhibitors that could treat multiple inflammatory conditions. Startup Expedition Therapeutics just signed a deal with Fosun Pharma for most rights to a DPP-1 inhibitor, while Boehringer Ingelheim and Haisco Pharmaceutical Group have drugs in development.
    • “Wall Street analysts forecast as much as $6 billion in annual sales for Brinsupri. Insmed’s market valuation has swelled to more than $25 billion in anticipation of coming sales from Brinsupri, its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “Fewer Americans are reporting that they drink alcohol amid a growing belief that even moderate alcohol consumption is a health risk, according to a Gallup pollopens in a new tab or window released Wednesday.
    • “A record high percentage of U.S. adults, 53%, now say moderate drinking is bad for their health, up from 28% in 2015. The uptick in doubt about alcohol’s benefits is largely driven by young adults — the age group most likely to believe drinking “one or two drinks a day” can cause health hazards — but older adults are also now increasingly likely to think moderate drinking carries risks.
    • “As concerns about health impacts rise, fewer Americans are reporting that they drink. The survey found that 54% of U.S. adults said they drink alcoholic beverages such as liquor, wine, or beer. That’s lower than at any other point in the past three decades.
    • “The findings of the poll, which was conducted in July, indicate that after years of many believing that moderate drinking was harmless — or even beneficial — worries about alcohol consumption are taking hold. According to Gallup’s data, even those who consume alcohol are drinking less.”
  • Health Day informs us,
    • “Nearly 70 percent of U.S. children in car crashes with a fatality are not using proper child passenger restraints, according to a study published online July 31 in Traffic Injury Prevention.
    • “Arthi S. Kozhumam, from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues identified child, driver, vehicle, neighborhood, and policy-level factors associated with suboptimal child passenger safety practices in motor vehicle collisions (MVCs) with a fatality. The analysis included data from child passengers (younger than 13 years old) in cars and light trucks with known restraint status and seating location identified from the Fatality Analysis Reporting System database (2011 to 2021).”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-supported clinical trial has found that the outcome of treating complicated Staphylococcus aureus bloodstream infections with two intravenous (IV) doses of the antibiotic dalbavancin seven days apart is just as good as daily IV doses of conventional antibiotics over four to six weeks. Nearly 120,000 S. aureus bloodstream infections and 20,000 associated deaths occurred in the United States in 2017. The study results provide the clearest evidence to date for the safety and effectiveness of dalbavancin therapy for complicated S. aureus bloodstream infections, expanding the number of antimicrobial treatment options for clinicians and patients. The findings were published today in the Journal of the American Medical Association.
    • “Given the small number of antimicrobial drugs available to treat Staphylococcus aureus bloodstream infections and the bacteria’s growing drug resistance, establishing dalbavancin as a beneficial therapy for these severe infections gives us a vital new alternative to treat them,” said John Beigel, M.D., the acting director of the Division of Microbiology and Infectious Diseases at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial.”
  • Medscape offers “Perspectives on Managing Antibiotic Resistance.”
  • Per MedPage Today,
    • “Men had higher mortality and hospitalization rates than women after a dementia diagnosis.
    • “These relationships held even after controlling for age and comorbidity burden.
    • “The study was based on over 5.7 million Medicare patients with up to 8 years of follow-up.”
  • and
    • “Applying five published definitions for long COVID yielded a prevalence that ranged from 30.84% to 42.01% at 3 months and 14.23% to 21.94% at 6 months.
    • “Up to a third of the variation in prevalence rates could be attributed to the differences in long COVID definitions.
    • “While ideal, there may never be a single, standardized long COVID definition, given the divergent needs of researchers and clinicians.”
  • and
    • “Clear” e-cigarettes had disproportionately greater cardiovascular effects than other types of vapes when smoking conditions were controlled.
    • “Clear” e-cigarettes contained synthetic coolants, menthol, and other flavorings despite their marketing.
    • “Acute increases in blood pressure may be related to the synthetic coolants reducing tobacco or nicotine harshness and facilitating deeper inhalation.”
  • The National Institute of Standards and Technology explains why “Wearable, Implantable and Ingestible Medical Devices Could Revolutionize Your Health Care.”
  • Genetic Engineering and Biotechnology reports,
    • “Targeted DNA editing by CRISPR technology has great potential for applications in biotechnology and gene therapy. However, precise gene editing remains a challenge largely due to insufficient control of the DNA repair process. While mechanisms exist to accurately repair double-stranded breaks, DNA end joining repair can occasionally lead to genetic errors.  
    • “In a new study published in Nature Biotechnology titled, “Precise, predictable genome integrations by deep learning–assisted design of microhomology-based templates,” researchers at the University of Zurich (UZH) have found that repair at the genome-cargo interface is predictable by artificial intelligence (AI) models and adheres to sequence-context-specific rules. The AI tool, named “Pythia,” predicts how cells repair their DNA after it is cut by CRISPR/Cas9 and opens the door to more accurate modeling of human diseases and next-generation gene therapies. 
    • “Just as meteorologists use AI to predict the weather, we are using it to forecast how cells will respond to genetic interventions. That kind of predictive power is essential if we want gene editing to be safe, reliable, and clinically useful,” said Soeren Lienkamp, PhD, professor at the Institute of Anatomy of UZH and co-corresponding author of the study.” 

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Providence posted a $21 million operating loss (-0.3% operating margin) for the second quarter of the year as elevated volumes and revenues outpaced year-over-year expense increases.
    • “The operating performance is an improvement over the prior year’s $123 million operating loss (-1.6% operating margin), for which the 51-hospital nonprofit credited its “continued focus on staffing and reductions from expense management initiatives.” The system is sitting at a $265 million operating loss (-1.7% operating margin) across six months.
    • “Providence executives cheered the system’s steady march toward breakeven after several consecutive years of losses.
    • “Still, the organization stressed a slew of economic headwinds it refers to as a “polycrisis” affecting nonprofit health systems like Providence as cause for continued expense reduction. Among these are inflation, tariffs, new state regulations around staffing and charity care, payment delays from commercial payers and the impending federal funding cuts of the “one big, beautiful bill.” 
  • and
    • “Health tech and artificial intelligence companies see ripe opportunities to offer solutions that help patients access and share their medical data with digital health apps. And it comes at a time when the federal government is pushing for consumer-directed data exchange.
    • “HealthEx, a company that built data rights management solutions, launched a platform to provide real-time patient access to complete health records. The company worked with a team of industry partners to develop a process that verifies patient identity, captures consent and retrieves clinical records, enabling the data to flow without the patient doing multiple patient portal logins.
    • “The company aims to create an “Apple Wallet” for health records, executives said.
    • “CLEAR, an identity verification tech company often found at airports, worked with HealthEx on the initiative, along with national electronic health record company athenahealth, healthcare interoperability company MedAllies and the CommonWell Health Alliance.”
  • Beckers Hospital Review points out,
    • “Three-quarters of the hospitals on U.S. News & World Report’s 2025-26 Honor Roll list also earned top marks in CMS’ latest Overall Hospital Quality Star Ratings, underscoring a notable overlap in national measures of hospital excellence. 
    • “CMS released its 2025 star ratings Aug. 6, evaluating more than 4,600 hospitals nationwide on 46 quality measures spanning mortality, safety, patient experience, readmissions, and timely and effective care. This year, 290 hospitals earned a five-star rating. U.S. News published its 2025-26 Honor Roll on July 29, recognizing 20 hospitals for top performance across 15 specialties and 22 procedures and conditions.
    • “While the two lists use different methodologies and scoring systems, their alignment highlights organizations that excel across quality- and reputation-based benchmarks.”
  • Beckers Payer Issues notes,
    • “Optum has acquired Kingsport, Tenn.-based Holston Medical Group, WJHL reported Aug. 11. 
    • “The 200-provider medical group has more than 70 locations in Northeast Tennessee and Southwest Virginia, according to the report. 
    • “Holston Medical Group is pleased to join Optum to support our efforts to continue to provide exceptional health care services to patients in the communities we serve,” an Optum spokesperson said in a statement shared with the news outlet. “Holston Medical Group and Optum share common goals around providing patients with high-quality, local care with a focus on value and innovation. We look forward to the breadth of clinical expertise and capabilities that we will gain as part of Optum.”
  • Per BioPharma Dive,
    • “PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been advancing through clinical testing.
    • “Called Celea Therapeutics, the company debuts with a drug candidate nearing late-stage trials that the company believes could treat multiple inflammatory lung diseases. Known as deupirfenidone or LYT-100, the drug is initially being evaluated against idiopathic pulmonary fibrosis, a rare and chronic condition. 
    • “Sven Dethlefs, who has spearheaded the deupirfenidone program under PureTech over the last year, will lead Celea. Prior to joining PureTech, Dethlefs was the CEO of Teva North America, where he oversaw the company’s specialty and generic businesses in the U.S. and Canada.”
  • Per MedTech Dive,
    • “Heartflow’s initial public offering grossed $364.2 million after the volume and price of the shares sold exceeded the original expectations.
    • “The company listed last week and completed the sale of the overallotment on Monday, adding almost $50 million through the sale of additional shares.
    • “Heartflow’s stock rose in its first two days on public markets, closing at almost $30 on Monday. The company priced its IPO at $19 a share.
    • “Heartflow has developed software for making 3D heart models from coronary computed tomography angiography scans. In a clinical trial, the company linked its lead product, Heartflow FFRCT Analysis, to a 78% improvement in identifying patients in need of revascularization.”

Tuesday report

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Senate confirmed Susan Monarez to be Director of the Centers for Disease Control and Prevention today by a 51 to 47 vote. The AP adds,
    • “She holds a doctorate in microbiology and immunology from the University of Wisconsin and did postdoctoral research at Stanford University. Prior to the CDC, Monarez was largely known for her government roles in health technology and biosecurity.”
  • MedCity News tells us,
    • “On Thursday, a coalition of 28 healthcare organizations sent a letter to leaders in Congress calling on them to extend the Affordable Care Act enhanced premium tax credits, which are set to expire at the end of the year.
    • “The letter was addressed to John Thune, Senate majority leader; Chuck Schumer, Senate minority leader; Mike Johnson, speaker of the House; and Hakeem Jeffries, minority leader of the House. The letter was led by Keep Americans Covered and was signed by healthcare organizations including AHIP, Blue Cross Blue Shield Association, the American Medical Association, Kaiser Permanente, Families USA and more.” 
  • STAT News reports,
    • “Health secretary Robert F. Kennedy Jr. could “imminently” overhaul a key federal advisory panel that recommends which preventive services insurers must pay for, according to a person familiar with the plans. 
    • “The person said that federal health officials are actively vetting new members for the U.S. Preventive Services Task Force. David Mansdoerfer, an adviser to a Kennedy-aligned group of physicians, said he’s aware of people being considered for the panel, but declined to name them.” * * *
    • “Mansdoerfer added that the existing panel is “M.D. heavy” and a reconstituted panel is more likely to include “allied health professionals,” which are health care providers who aren’t nurses or physicians, like physical therapists and dietitians.” 
  • Following up on yesterday’s post about Medicare Part D, here is a link to the CMS guidance upon which the Wall Street Journal relied.
  • World at Work informs us,
    • “Health savings accounts (HSAs) have become a staple total rewards offering over the last decade, but a new study by the Employee Benefit Research Institute (EBRI) showed employees are still leaving the full value of these accounts on the table.
    • “The June 12 EBRI report pulled data from 14.5 million accountholders, containing more than $48 billion in total assets — roughly 40% of the entire HSA universe. The analysis revealed:
      • “Low balances. End-of-year balances increased in 2023 (the most recent analysis period) to $4,747 but are still modest compared with average out-of-pocket maximums for HSA-eligible health plans ($8,300 for individual coverage in 2025, $16,600 for family coverage)
      • “Low contributions. Relative to 2022, average HSA contributions increased in 2023. However, after adjusting for inflation, both employer and employee contributions were higher in the 2010s. Also, notably, the average combined HSA contribution was $760 less than the statutory maximum contribution for individuals and $4,660 less than the statutory maximum contribution for accountholders with family coverage.
      • “High withdrawals. More than half of accountholders withdrew funds, and the average distribution rose to $1,801.
      • “Low investment. Only 15% of accountholders invested in assets other than cash. 
    • EBRI found that, essentially, employees use HSAs as specialized checking accounts rather than investment accounts, and in doing so, miss out on the triple tax advantage available if they maximize contributions, minimize withdrawals and invest their balances.
    • “The good news is that, here we are 20-plus years after HSAs launched, and they’ve become pretty standard. They’re a typical plan offering from most employers of all sizes — not just large or small companies, or in certain industries,” said Alexander Domaszewicz, a principal and healthcare consultant at advisory firm Mercer. “If we live long enough, we’ll have healthcare expenses, and we want to be prepared for that. But while awareness and visibility of HSAs have grown, they’re still intimidating to folks.”
  • Beckers Payer Issues calls attention to recent No Surprises Act developments.
  • Federal News Network lets us know,
    • “The Trump administration is detailing how it expects agencies to recruit more political appointees through the new “Schedule G” hiring category, while also reminding agencies that all non-career hires must be approved by the White House.
    • “The Office of Personnel Management on Tuesday outlined how agencies should adopt the federal employment classification President Donald Trump created earlier this month. Generally, the new Schedule G broadens agencies’ options for hiring political appointees, beyond the avenues already available to presidential administrations for picking their own staff members.
    • “In its guidance on Trump’s new hiring authority, OPM said agencies will have to run any Schedule G hires they want make by the White House for review and approval.
    • “As a matter of practice,” OPM said, agencies will have to send all their political hires to their White House liaison — a position that coordinates with the White House on hiring and retention of political appointees — before agencies can advance any Schedule G appointments.”

From the Food and Drug Administration front,

  • Bloomberg Law informs us,
    • “Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy. 
    • “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” Department of Health and Human Services spokesperson Andrew Nixon said in a written statement. 
    • “Prasad did not immediately respond to a request for comment about his departure.” 
  • The Washington Post reports,
    • “The Food and Drug Administration pushed Tuesday to restrict a synthetic opioid found in tablets, gummies and drinkable shots commonly sold in convenience stores.
    • “Health officials announced they will seek to add 7-OH — a potent substance synthesized from a compound in the kratom leaf — to the tier of controlled substances reserved for the most addictive drugs, such as heroin and LSD.
    • “The FDA, researchers and kratom companies have grown increasingly alarmed by the rise of 7-OH products they say are distinct from all-natural teas and powders derived from a leaf that grows on trees native to Southeast Asia.
    • “FDA Commissioner Marty Makary said at a news conference that the agency is not asking to restrict natural products made from kratom, which contains trace amount of the compound. In a report released Tuesday, the agency said it maintains concerns about kratom broadly but needed to act urgently on 7-OH because of its risk of sedation, nausea, breathing problems and addiction.”
  • From the judicial front,
    • Fierce Healthcare reports,
      • “A new law in Arkansas banning pharmacy benefit managers from owning pharmacies has been blocked by a federal judge, the latest development in one of the industry’s most-watched new pieces of legislation.
      • “Judge Brian Miller said the law may violate (PDF) the Commerce Clause in the constitution and is likely preempted by TRICARE, a health care program for military families. The state is barred from enforcing the law until final disposition, a ruling shows.
      • “Act 624 appears to overtly discriminate against plaintiffs as out of state companies and the state has failed to show that it has no other means to advance its interests,” said Miller, adding other enacted state laws already can properly restrict PBMs.
      • “Arkansas Attorney General Tim Griffin said he plans on appealing the decision, reported the Associated Press.
      • “We’re pleased with the Court’s decision to grant a preliminary injunction to stop the implementation of Act 624,” a CVS Health spokesperson said in a statement. “We continue to be focused on serving people in Arkansas and are actively looking to work together with the state to reduce drug prices and ensure access to pharmacies.”

From the public health and medical researach front,

  • KFF considers whether our country’s measles elimination status is at risk.
  • The Agency for Healthcare Research and Quality released a medical expenditures survey report titled “Healthcare Expenditures for Heart Disease among Adults Aged 18 and Older in the U.S. Civilian Noninstitutionalized Population, 2022.”
    • “In 2022, 7.8 percent of adults aged 18 and older were treated for heart disease, and men were more likely than women to have treated heart disease (8.4 % vs. 7.2%).
    • “Among age groups, the treated prevalence of heart disease was highest for those aged 65 and older (22.8%) compared to only 6.0 percent for adults aged 45-64, and 1.4 percent for adults ages 18-44.
    • “In 2022, healthcare expenditures to treat heart disease for adults in the US totaled $100.0 billion (with an average cost of $4,900 per adult with diagnosed and treated heart disease).
    • “The largest portion of heart disease expenditures were incurred through hospital inpatient stays (46.1%) and prescribed medications (20.5%).
    • “The majority of heart disease treatment costs were paid by Medicare (57.6%) and private insurance (24.2%).”
  • Per MedPage Today,
    • “The global incidence of liver cancer is projected to double by 2050.
    • “Sixty percent of liver cancers are preventable by controlling risk factors including hepatitis B and C, alcohol consumption, and MASLD.
    • “The Lancet Commission estimated that a 2-5% reduction in the age-standardized incidence rate of liver cancer could prevent up to 17.3 million new cases and save up to 15.1 million lives.”
  • Per Neurology Adviser,
    • “Urinary tract infections (UTIs) may be a trigger for myocardial infarction (MI) or stroke, with an increased risk for both within the first 7 days of infection, according to the findings of a study published in BMJ Open.”
    • “Growing evidence suggests that acute infection plays a role in the pathogenesis of cardiovascular disease.
    • “Researchers from Cardiff University in the United Kingdom conducted this self-controlled cases series using data from the Secure Anonymised Information Linkage (SAIL) Databank which houses nation-wide data from Wales. Patients (N=105,930) with MI (n=51,660) or stroke (n=58,150) between 2010 and 2020 were evaluated for general practitioner suspected or confirmed UTI before or after MI or stroke event. The peak risk period was defined as up to 90 days after UTI.
    • “The MI and stroke cohorts consisted of 63% and 49% men, with mean ages of 69 and 74 years for men and 77 and 79 years for women, respectively.”
  • STAT News reports,
    • “A major Alzheimer’s disease medical group is recommending that specialists may use certain blood tests to help diagnose patients with cognitive impairment in lieu of more complex and invasive tests, a move that could lead more people to get treated for the devastating disease.
    • “The Alzheimer’s Association, in its first clinical guidelines on blood biomarker testing, said Tuesday that tests that have over 90% sensitivity (ability to identify positive results) and 90% specificity (ability to identify negative results) can be used instead of current diagnostic methods like PET scans and cerebrospinal fluid tests.
    • “The group said that tests that have over 90% sensitivity and 75% specificity can be used to triage patients, meaning negative results rule can rule out Alzheimer’s with high probability but positive results should be confirmed with the standard diagnostic methods, given that these blood tests have a higher likelihood of false positives.
    • “The authors stressed that the guidelines should not be considered a substitute for a full clinical evaluation and that they apply only to people who are in the care of specialists and have already been confirmed to have cognitive impairment. The authors also noted that there’s wide variability in the blood tests on the market and that many do not meet the accuracy thresholds.”
  • Per Benefits Pro,
    • “Researchers at Cigna’s Evernorth Research Institute are seeing early signs that offering patients semaglutide and other GLP-1 agonists might cut the cost of managing mental health problems.
    • “Duy Do and two other Evernorth researchers found that using Ozempic or similar drugs to control blood sugar reduced use of office visits to treat depression by 13% and reduced use of office visits to treat anxiety by 15%.
    • “Use of GLP-1 agonists did not reduce use of emergency room visits or inpatient care for depression or anxiety, but the researchers say their work shows the need for understanding how GLP-1 agonist use affects people’s mental health and use of mental health services.
    • “Given the high economic burden of mental health disorders among patients with T2DM, further research is needed to confirm the clinical and cost-effectiveness of [GLP-1s] in reducing the overall health care burdens for this patient population,” Do and colleagues conclude.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “UnitedHealth Group anticipates its 2025 earnings to fall below expectations due to rising costs and operational issues.
    • “CEO Stephen Hemsley aims to restore UnitedHealth to high performance, projecting earnings growth for the coming year.
    • “UnitedHealth is facing industry upheaval with rising healthcare costs, government actions, and ongoing Justice Department probes.”
  • Modern Healthcare tells us,
    • “Humana is offering certain employees voluntary early retirement buyouts.
    • “Employees age 50 or older with at least three years of service are eligible for the program, although those working in certain business-critical areas will be ineligible, a company spokesperson said Tuesday. He said the window to apply for voluntary early retirement will be open for several weeks.
    • “The Louisville, Kentucky-based health insurer said the offers are part of ongoing evaluations Humana conducts to adjust staffing and drive organizational efficiency.”
  • Beckers Hospital Review lets us know,
    • “U.S. News & World Report released its 2025-2026 Best Hospitals rankings and ratings July 29, which included its list of 504 Best Regional Hospitals across 49 states and 95 metropolitan areas.
    • “The latest edition of Best Hospitals, now in its 36th year, evaluated more than 4,400 hospitals on measures such as risk-adjusted mortality rates, preventable complications and level of nursing care.” 
    • The article lists the no. 1 ranked hospitals in each eligible state.
  • Cardiovascular Business points out the best heart hospitals according to U.S. News and World Report.
  • Fierce Healthcare informs us,
    • “Earlier this year, CVS Health announced that it would invest $20 billion in improving the consumer experience and making the healthcare journey simpler.
    • “Now, its health benefits arm, Aetna, is unveiling its new Care Paths program, which connects members who have certain health needs—launching with diabetes, joint health and maternity care—to a more personalized view of their benefits and more directly with the care team supporting them. The platform is powered by artificial intelligence and offers users individualized recommendations for health and wellness programs related to their conditions as well as care kits when available.
    • “The goal, the insurer said, is to make members’ interactions with their health plans feel less transactional and instead more holistic. Aetna offered an exclusive look at the new offering to Fierce Healthcare.”
  • and
    • “Sword Health, a company that provides virtual physical therapy and mental health, is now offering an AI assistant for payers and providers to tackle operational and administrative tasks.
    • “The new AI division marks a notable expansion from the company’s core business of virtual care services like digital musculoskeletal care, pelvic health and movement health.
    • “The launch of the new division, called Sword Intelligence, marks a “pivotal evolution” in Sword Health’s strategy, according to the company.
    • “Sword Intelligence allows us to move beyond delivering care to our own members to enabling the entire healthcare industry to scale it efficiently and effectively,” Virgilio “V” Bento, founder and CEO of Sword Health, told Fierce Healthcare when reached via email.”
  • The Wall Street Journal further reports,
    • “Merck & Co. said it is embarking on a multi-year cost-savings plan, which includes cuts to its workforce and real-estate footprint, as it looks to redirect resources toward new product launches.
    • “The plan comes as the drug company on Tuesday logged lower revenue and sales in its latest quarter and narrowed its full-year guidance.
    • “The company said it expects the plan to result in $3 billion in annual cost savings by the end of 2027, which it plans to reinvest to support new products as well as its pipeline across multiple therapeutic areas.
    • “As part of the cost-savings plan, Merck expects to eliminate certain administrative, sales and research-and-development positions.
    • “The company didn’t disclose how many workers would be affected but said it would continue to hire employees in new roles across strategic growth areas of its business.
    • “Merck said it also would reduce its global real-estate footprint and continue to optimize its manufacturing network.
    • “The company expects the workforce cuts and real-estate reductions to result in annual cost savings of about $1.7 billion, which would be substantially realized by the end of 2027.”
  • and
    • “Novo Nordisk shares plunged after losing its lead in the weight-loss drug market to competitors like Eli Lilly.
    • “The company lowered its 2025 sales growth forecast due to copycat versions of Wegovy and slower Ozempic sales.
    • “Maziar Mike Doustdar was named chief executive, effective Aug. 7, succeeding Lars Fruergaard Jorgensen.”

Friday report

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s second weekly blog post which is titled “Rightsizing with a purpose.”
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. is planning to remove all the members of an advisory panel that determines what cancer screenings and other preventive health measures insurers must cover, people familiar with the matter said.
    • “Kennedy plans to dismiss all 16 panel members of the U.S. Preventive Services Task Force because he views them as too “woke,” the people said.
    • “The White House has made a priority of targeting initiatives that promote diversity equity and inclusion, or DEI, in everything from artificial intelligence to health research grants.
    • “The task force has advised the federal government on preventive health matters since 1984. The Affordable Care Act in 2010 gave it the power to determine which screenings, counseling and preventive medications most insurers are required to cover at no cost to patients. The group, made up of volunteers with medical expertise who are vetted for conflicts of interest, combs through scientific evidence to determine which interventions are proven to work.
    • “The Supreme Court decided a case in June that centered on a task-force recommendation to cover HIV-prevention drugs. The employer plaintiffs in the case had argued that requiring them to cover such drugs for employees violated their religious rights and that the task-force members weren’t properly appointed. The high court ruled that the task- force appointments were constitutional, while highlighting that the Health and Human Services Secretary has the authority to remove the members of the panel at will.”
  • Per a Senate news release,
    • Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Maggie Hassan (D-NH), and Roger Marshall, M.D. (R-KS) highlighted the importance of fully implementing the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it. This bipartisan legislation was signed into law by President Trump in 2020 as part of his efforts to improve price transparency and lower health costs for American patients.
    • “Nearly five years ago, President Trump signed the No Surprises Act (P.L. 116-260) into law. This historic, bipartisan legislation protects patients from surprise medical bills and ensures that they know the cost of care before receiving it,” wrote the senators. “Ensuring that patients have transparent, personalized cost estimates for their health care is a bipartisan priority. Full implementation of both the good faith estimate and advanced explanation of benefits are critical to providing patients with the entirety of protections enacted under the No Surprises Act…We commend President Trump’s commitment to price transparency and stand ready to assist to ensure a successful and complete implementation of the No Surprises Act.”
    • Since the bipartisan legislation led by Senators Cassidy and Hassan was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • To build on this success, the senators are requesting rules to implement provisions in the law to give covered patients clear cost estimates before their scheduled medical care. To date, the good-faith estimate has been implemented for uninsured and self-pay patients. Additional rulemaking is needed to implement the good-faith estimate and the advanced explanation of benefits for covered patients. For a patient with insurance, providers and facilities are required to provide the good-faith estimate to the individual’s health plan or issuer of coverage, which in turn, must use the estimate to give the patient an advanced explanation of benefits outlining what the plan will cover and what the individual will owe out of pocket.
    • Read the letter here 
  • If Congress wants to improve the No Surprises Act, it should refine the dispute resolution process.
  • Healthcare Dive tells us,
    • “More than 200 telehealth and provider organizations are asking the Trump administration to hammer out regulation governing telehealth prescriptions of controlled substances before pandemic-era flexibilities expire at the end of the year. 
    • “In a letter sent to Terry Cole, the newly confirmed administrator of the Drug Enforcement Administration, the groups urged the administration to ensure a plan is in place by fall so patients can continue to receive remote prescriptions of controlled substances.
    • “The Biden administration proposed a framework for telehealth prescriptions just before President Joe Biden left office in January, but some industry groups have panned the proposed rule as too onerous for providers.”

From the public health and medical research front,

  • The U.S. Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 model-based epidemic trends (Rt) and wastewater activity levels indicate that COVID-19 activity is increasing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department visits rose 4.8% compared to the week before, mainly in children up to 4 years old. Test positivity rose slightly and is now at 5.3% nationally, with levels highest in the Southwest, followed by the South.
    • Wastewater SARS-CoV-2 detections remained at the low level and are highest in the West, with other regional hot spots, including Louisiana with very high activity and Florida with high activity.
    • “The CDC has not updated its variant proportion estimates since the middle of June owing to low numbers of sequences reported when the NB.1.8.1 subvariant was the most common. Variant proportions predicted from testing in international travelers during the same period suggested the XFG variant—one of many JN .1 offshoots— was most common. Both are considered variants under monitoring by the World Health Organization, which in late June said XFG seems to have a moderate growth advantage and a low risk of immune escape, though it added that confidence in its assessments were low because of recent expansion and low sequencing levels.”
  • The CDC also reports,
    • “Tetrahydrocannabinol (THC), a psychoactive substance found in Cannabis sativa plants, including varieties such as hemp, is increasingly being used in consumer products.
    • “During October 22–24, 2024, at least 85 persons, ranging from age 1–91 years, ate food from a restaurant in Wisconsin and experienced symptoms consistent with THC intoxication. The restaurant was in a building with a cooperative (i.e., shared) kitchen used by a state-licensed vendor who produced edible THC products. The restaurant mistakenly used THC-infused oil from the cooperative kitchen to prepare dough.
    • “Clinicians and public health practitioners should be alert to the possibility of mass THC intoxication events via food.
  • Doug Corley, MD, PhD, of The Permanente Medical Group, tells us why rising colon cancer rates—up 2% yearly in younger patients—demand earlier screening.
    • “Younger people are at increased risk compared to what they were,” said Doug Corley, MD, PhD, chief research officer for The Permanente Medical Group. Colorectal cancer “is a substantial problem, and it causes a lot of mortality … and morbidity.”
    • “The Permanente Medical Group is a part of the AMA Health System Member Program, which provides enterprise solutions to equip leadership, physicians and care teams with resources to help drive the future of medicine.
    • “Dr. Corley discussed the growing concerns about colon cancer in younger people, as well as how The Permanente Medical Group is helping these populations in a recent episode of “AMA Update.”
  • The American Hospital News lets us know,
    • “A report from AARP and the National Alliance for Caregiving released today found nearly 1 in 4 U.S. adults (63 million) are caring for an adult or child with a complex medical condition or disability. Over half of the caretakers are managing complex medical and nursing tasks like injections, wound care or medication management, though only 20% have training to do so.”
  • Per Medscape,
    • “Urgent care visits frequently result in inappropriate prescribing, with 12.4% leading to antibiotic fills, 9.1% to glucocorticoid fills, and 1.3% to opioid fills. Analysis of over 22.4 million urgent care visits revealed concerning patterns, including 40.8% of acute bronchitis visits resulting in inappropriate glucocorticoid prescriptions.” * * *
    • “Inappropriate prescribing in urgent care is influenced by clinician knowledge, patient demands, and lack of decision support. Antibiotic, glucocorticoid, and opioid stewardship programs are needed to reduce inappropriate urgent care prescribing and support long-term glucocorticoid and opioid deprescribing efforts,” wrote the authors of the study.”
    • “The study was led by Shirley Cohen-Mekelburg, MD, MS, Division of Gastroenterology and Hepatology and Institute for Healthcare Policy and Innovation, University of Michigan in Ann Arbor, Michigan. It was published online on July 21 in Annals of Internal Medicine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Centene swung to a loss in the second quarter and offered a drastically reduced projection for full-year earnings, delivering a result even worse than Wall Street feared amid growing signs of a financial meltdown across the health-insurance industry.
    • “The managed-care company, which focuses on Medicaid, Affordable Care Act plans and Medicare, withdrew its earnings guidance for 2025 earlier this month, citing rising costs in Medicaid and problems in the ACA business. 
    • “Centene’s latest woes come after smaller competitor Molina Healthcare reduced its 2025 earnings projection for the second time in a month, and larger Elevance Health reported cost pressures as well. Industry bellwether UnitedHealth Group is set to report earnings next Tuesday, after earlier this year withdrawing its own guidance and replacing its chief executive. 
    • “The entire industry is contending with rising costs as well as a shifting membership and regulatory landscape across various lines of business that appear to have weakened insurers’ ability to predict the risks of the populations they enroll—a fundamental function.
    • Centene said in a conference call with analysts on Friday that it expects results to improve next year as it seeks higher payments and tightens its operations.” 
  • STAT News adds,
    • “Hospitals’ finances are strongly influenced by two factors: the prices they negotiate with insurers and how many patients they treat in their facilities. Right now, the latter does not appear to be the main driver of their strong profits. Inpatient and outpatient surgeries, which tend to be hospitals’ profit centers, were down slightly at both companies. Admissions barely budged. Another hospital chain, Community Health Systems, reported similarly underwhelming patient numbers this week. 
    • “It’s a different story among insurers, who say they’re being forced to shell out more money than usual for their members’ medical costs, particularly those who rely on Medicaid and Affordable Care Act plans. Elevance’s finance chief described what’s happening as a “market-wide morbidity shift,” meaning patients are sicker than the companies had expected when they priced their policies.
    • “One number may help explain why hospitals are faring well as insurers struggle: the amount of money hospitals make on each patient. In Tenet’s outpatient surgery business, revenue per case was up 8.3% year-over-year on a same-facility basis. In its hospital segment, that metric grew 5.2%. Tenet chalked that up to charging insurers higher prices — framed as patients having better-paying insurance — and its focus on offering higher-acuity services like cardiac care and orthopedics. At HCA, revenue per admission grew 4% year-over-year on a same-facility basis.”
    • “And consider which services are at issue for insurers. On the Medicaid front, Elevance said its members are using more home health, transportation, adult day care, and services to help them with daily activities like bathing and dressing. They’re also getting more behavioral health services and inpatient surgeries. As for people on ACA plans, the increase in care is concentrated among emergency room visits, behavioral health services, and high-cost drugs. 
    • “But on Friday, HCA said it’s seeing less demand for services among Medicaid patients.”
  • Here’s a link to a Beckers Hospital Review story about HCA’s second quarter earnings announcement.
    • “Nashville, Tenn.-based HCA Healthcare has reported “16 consecutive quarters of volume growth,” highlighting the strength of its diversified network of markets and services, CEO Sam Hazen said July 25 during the company’s second-quarter earnings call.
    • “The for-profit health system reported a 1.7% year-over-year increase in equivalent admissions for the second quarter and a 2.3% rise year-to-date. YTD managed care equivalent admissions — including the exchanges — increased 4%, in line with HCA’s expectations, according to CFO Mike Marks. Medicare grew 3%, slightly below the company’s expectations.
  • Per Beckers Payer Issues,
    • “With GLP-1 medication costs being a top concern for employers heading into 2026, UnitedHealthcare is addressing the challenge through its Total Weight Support program, aimed at improving weight loss outcomes for employees while managing the costs of medication adherence. 
    • “In our conversations and consultations with employers, they are all looking for solutions for their employees who are dealing with obesity and metabolic conditions that bring better value,” Rhonda Randall, DO, chief medical officer for UnitedHealthcare’s commercial business, told Becker’s. “Total Weight Support was put into the marketplace as a comprehensive solution for employers who are looking for that full-person approach to care for their beneficiaries and employees dealing with obesity.”
  • Mercer consulting offers detailed compliance consideration for GLP-1 drug coverage.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Mental health care, NCQA, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “President Trump created another new category of federal employee on Thursday evening, issuing an executive order to expand the number of political appointees who do not require Senate confirmation and will serve in policy-making or policy-advocating roles. 
    • ‘While presidents can already tap an uncapped number of appointees to serve in Schedule C positions, Trump noted those individuals serve in more narrow confidential or policy-determining roles. The new positions will therefore fill a gap that currently exists in federal appointments, the White House said. 
    • “The order is the latest in Trump’s effort to establish a tighter grip on the executive branch and its actions. He has already created Schedule Policy/Career, formerly known as Schedule F, which is similarly defined to Schedule G but reserved for career civil servants. Agencies are in the process of determining who qualifies for conversion to Schedule Policy/Career and those employees will become easier to fire for any reason.” 
  • Federal News Network tells us,
    • “The Postal Service’s new chief executive is defending the agency’s current operating model, at a time when the Trump administration considers challenging its independence.
    • “David Steiner, former FedEx board member and Waste Management CEO, began his tenure as postmaster general on Tuesday.
    • “Steiner told employees Thursday he supports keeping USPS independent from the executive branch and defended the 10-year reform plan of his predecessor, former Postmaster General Louis DeJoy.
    • “Steiner told employees in a video message on Thursday that, “I do not believe that the Postal Service should be privatized, or that it should become an appropriated part of the federal government.”
    • “I believe in the current structure of the Postal Service as a self-financing, independent entity of the executive branch,” Steiner said. “My goal for the Postal Service is to meet the financial and service performance expectations of our nation under this structure.”
  • The American Hospital Association News informs us,
    • “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
  • The Centers for Medicare and Medicaid Services shares highlights from its 2025 Quality Conference held earlier this month.
  • KFF, writing in Fierce Healthcare, criticizes the No Surprises Act. No law is perfect.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
    • “Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The FDA subsequently began a formal investigation of Elevidys’ liver risks. 
    • “Reuters first reported news of the FDA’s request. FDA Commissioner Martin Makary told Bloomberg in an interview Friday that his agency is weighing whether to withdraw Elevidys from the market entirely. 
    • “The news comes on the heels of Sarepta reporting this week the death of a 51-year-old man who received an experimental gene therapy it’s developing for another kind of muscular dystrophy known as limb-girdle. The man died of complications from acute liver failure in June. 
    • “While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.”
  • The New York Times adds,
    • In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.
    • In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Ele­vidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.
    • In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.
  • BioPharma Dive points out,
    • “A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.
    • “Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.
    • “The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.”
  • Healthexec notes,
    • “The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
    • “There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.”
  • Reuters adds,
    • “The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK’s (GSK.L)  blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.”

From the judicial front,

  • Healthcare Dive reports,
    • “A Texas federal judge has dismissed Humana’s lawsuit against the federal government seeking to improve its Medicare Advantage star ratings, in a significant loss for the insurer.
    • “Humana sued the CMS in October 2024 to reverse its quality scores, arguing that the agency acted arbitrarily and capriciously in downgrading the ratings, which are tied to billions of dollars in reimbursement, for 2025.
    • “However, District Judge Reed O’Connor ruled on Friday that Humana failed to exhaust administrative remedies before filing its lawsuit. Humana said it is exploring further legal action.”
  • Bloomberg Law lets us know,
    • “A federal judge refused Friday to remove an order that halted US Health Secretary Robert F. Kennedy Jr. from carrying out mass firings and restructuring across health agencies. 
    • “The US District Court for the District of Rhode Island disagreed with the Justice Department’s request to lift the order due to pending stays in two other cases that challenge with government’s reduction-in-force. Those cases are McMahon v. New York , regarding layoffs at the Department of Education, and Trump v. AFGE, regarding President Donald Trump’s reorganization of the federal government.” * * *
    • “Defendants misguidedly argue that the Supreme Court’s recent grants of stays pending appeals” in those cases mean that the court should immediately reverse its July 1 decision granting plaintiffs’ preliminary injunction, Judge Melissa R. DuBose for the US District Court for the District of Rhode Island said in the order. * * *
    • “DuBose rejected the government’s request to stay pending the appeal.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among young children 0-4 years old. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP tells us,
    • “Only 35% to 40% of US pregnant women and parents of young children say they intend to fully vaccinate their child, per survey results from researchers at Emory University and the Centers for Disease Control and Prevention (CDC).
    • “For the two surveys, published as a research letter this week in JAMA Network Open, the investigators recruited 174 pregnant women and 1,765 parents from a nationally representative panel in April 2024 to answer questions about their intent to have their child receive all recommended vaccines by 18 months.
    • “Many parents in the US choose to delay or refuse vaccines that are recommended for their child from birth to age 18 months,” the study authors wrote. “Research is necessary to understand the value of intervening during pregnancy to proactively support parents with vaccination decisions before the birth of the child, as implementation of such interventions will require substantial engagement of health care professionals and entities outside of the pediatric care setting.”
  • Per an NIH news release,
    • “Sjögren’s disease is a chronic autoimmune condition affecting up to four million Americans, characterized by symptoms such as dry eyes and mouth, fatigue, and inflammation in various organs. Although it primarily affects women, men tend to face more severe complications. The disease can impact pregnancy outcomes and increase risk for lymphoma. Despite extensive research, its underlying causes remain unclear, and current treatments mainly aim to manage symptoms.
    • “Recent NIH-supported research using mouse models sheds new light on Sjögren’s disease, pointing to dysfunction in regulatory T cells and a heightened interferon gamma response as key drivers of disease symptoms. A drug called baricitinib, already approved for conditions such as rheumatoid arthritis, showed promising results in mice by reducing inflammation and restoring gland function. The similarities between mouse and human immune responses suggest that baricitinib could be a viable future treatment for people with Sjögren’s disease, offering hope for more targeted therapies ahead.”
  • The Washington Post reports,
    • “A baby’s sex may not be up to mere chance.
    • “A study published Friday in the journal Science Advances describes the odds of having a boy or girl as akin to flipping a weighted coin, unique to each family. It found evidence that an infant’s birth sex is associated with maternal age and specific genes.
    • “The findings challenge assumptions that birth sex is random. They mirror the results of similar studies in Europe that have also found that birth sex does not follow a simple 50-50 distribution.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation’s private health insurance system.
    • “The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country’s largest private insurer, UnitedHealthcare.” * * *
    • “The analysis found that the most common reason for a drug claim to be rejected was that a refill had been requested “too soon,” before the patient was eligible for more medication.”
    • “Appropriate prescription drug denials can happen for numerous reasons, and many can be resolved within minutes,” said Greg Lopes, a spokesman for the Pharmacy Care Management Association, a trade group for pharmacy benefit managers.”
  • Beckers Payers Issues gives us a look inside the Humana-Mercy partnership “that’s shaping the future of health care.”
  • Behavioral Health Business tells us,
    • “Lyra Health, a national provider of mental health benefits for employers, has acquired Bend Health with the goal of strengthening its pediatric and neurodiversity capabilities. 
    • “Lyra’s acquisition of Madison, Wisconsin-based Bend Health was completed July 16. Exact terms of the deal were not disclosed in the press release.
    • “The move enables Lyra to utilize Bend Health’s collaborative care model and specialized providers to offer more comprehensive evaluations and virtual intensive outpatient care to its 20 million members.”
  • NCQA, writing in LinkedIn, discusses a new look for HEDIS that will arrive on August 1.

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, SCOTUS, Telehealth, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • Bloomberg Law tells us,
    • US Health Secretary Robert F. Kennedy Jr.’s decision to pull the Covid-19 vaccine from the CDC’s recommended immunization list for healthy children and pregnant women means health plans must navigate whether to keep providing coverage for the shot. * * *
    • “Kennedy’s announcement in a video posted on X appeared to skip recommendations from the Advisory Committee on Immunization Practices, a panel of outside medical experts who guide the CDC on vaccine policy and vote for any new or updated recommendations to the schedule.
    • “The ACIP holds weight because the Affordable Care Act and the Inflation Reduction Act tie coverage in the commercial and Medicaid markets to the committee’s recommendations, attorneys say. That committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who can’t to afford them. 
    • “The panel is currently scheduled to meet starting June 26 to consider Covid-19 vaccines.
    • “The HHS did not respond to request for comment on further details of the announcement.”
  • Fierce Pharma informs us,
    • “While the Trump administration’s threat of pharmaceutical import tariffs and most favored nation (MFN) drug pricing has weighed heavily on the pharmaceutical industry in recent months, many branded drugmakers are well-positioned to handle the pressures.
    • “That was the perspective offered in a new report by S&P Global, which suggests that many global pharma companies can endure pricing pressures, trade duties and more, and that some of the most concerning policies floated by President Donald Trump are unlikely to materialize as planned.
    • “Still, Trump’s ambition to impose a most favored nation (MFN) drug pricing policy—which would attempt to close the gap between the costs of U.S. drugs and those in other countries—would be “highly negative” to branded drugmakers’ credit quality if enacted, the S&P team cautioned.”

In Food and Drug Administration news,

  • BioPharma Dive lets us know,
    • “Abbott said Tuesday it received Food and Drug Administration approval for the Tendyne transcatheter mitral valve replacement system to treat calcium buildup in the ring that supports the heart valve.
    • “The device is available for patients with severe mitral annular calcification who are not candidates for open heart surgery or transcatheter mitral valve repair.
    • “Abbott’s MitraClip system for mitral valve repair competes with Edwards Lifesciences’ Pascal repair device. The rivals are now set to compete in mitral valve replacement: Edwards won Europe’s CE mark last month for the Sapien M3 transfemoral system and expects U.S. approval in 2026.”
  • and
    • “Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices. 
    • “Boston Scientific said in a regulatory filing that the decision followed recent discussions with regulators, adding that the products faced increased requirements to maintain approvals in global markets and to obtain approvals in new regions.”

From the judicial front,

  • Yesterday, the U.S. Solicitor General filed with the Supreme Court a requested amicus brief recommending that the Court not review a U.S. Court of Appeals for the 10th Circuit decision that overrode parts of Oklahoma’s PBM reform law based on ERISA and Medicare preemption. The Supreme Court is likely to make a ruling on this issue next month. The FEHBlog is happy about this development.
  • Modern Healthcare reports,
    • “An Elevance Health subsidiary is suing the billing dispute consulting company HaloMD and two hospital-based Georgia providers, alleging they conspired to exploit the No Surprises Act.
    • “Blue Cross Blue Shield Healthcare Plan of Georgia, which operates under Elevance Health’s Anthem brand, filed the suit in the U.S. District Court for the Northern District of Georgia on Tuesday. The company alleges HaloMD and its out-of-network clients inappropriately won higher reimbursements through the No Surprises Act’s independent dispute resolution, or IDR, system.
    • “Defendants procured improper payments from [Blue Cross Blue Shield of Georgia] on thousands of disputes. Indeed, nearly 70% of disputes on which defendants received an IDR payment determination were clearly ineligible for the process. Since 2024, defendants’ scheme has caused millions of dollars in damages, and it continues to harm [Blue Cross Blue Shield of Georgia], employer plan sponsors and other managed care companies,” the insurer wrote in its complaint.
    • “Elevance Health estimates it spent $5.9 million on excess reimbursements and IDR fees from Jan. 3, 2024, to April 29, 2025.”
    • Unquestionably the IDR system needs to become more transparent to the parties.

From the public health and medical research front,

  • ABC News relates,
    • “About a month ago, the rate of new measles cases was accelerating at a seemingly unprecedented rate with more than 100 infections being confirmed every week.
    • “However, over the last couple of weeks, the rate of newly confirmed cases appears to be slowing.
    • “The Centers for Disease Control and Prevention (CDC) confirmed an average of 22 weekly cases over the last two weeks.
    • “Even in western Texas, which had been driving most new cases in the U.S., about 11 cases have been confirmed since May 23.
    • “Public health experts told ABC News they believe measles cases are slowing down due to a mix of vaccination, a build of natural immunity and people staying home when sick.”
  • The Washington Post points out,
    • “Scores of researchers have produced new tools that can deliver genes and selectively activate them in hundreds of different cell types in the brain and spinal cord, a breakthrough that scientists hope advances them toward developing targeted therapies to treat neurodegenerative diseases such as ALS, Parkinson’s disease and Alzheimer’s.
    • “The discoveries, made through the National Institutes of Health’s BRAIN initiative, show with unprecedented clarity and precision how neural cells work together, but also how diseases disrupt their tight choreography. The insight offers the promise that doctors may one day treat diseases by manipulating dysfunctional cells.
    • “Looking ahead, with sustained investment, the advances we can achieve in understanding consciousness — and in repairing neurological and neuropsychiatric disorders — will be nothing short of life-changing,” Gord Fishell, a professor of neurobiology at Harvard Medical School and one of the scientists involved in the discoveries, said in an interview for the BRAIN webpage. “This will revolutionize both our grasp of how the brain works and our ability to treat currently intractable conditions.”
  • Per MedPage Today,
    • “Self-reported maternal mental health declined in recent years, as did maternal physical health, though less drastically, a cross-sectional study suggested.
    • “After adjustments for secular changes in sociodemographic groups, “excellent” physical health decreased by 4.2 percentage points, “excellent” mental health decreased by 12.4 percentage points, and “fair/poor” mental health increased by 3.5 percentage points from 2016 to 2023, reported Jamie Daw, PhD, of the Columbia University Mailman School of Public Health in New York City, and colleagues in JAMA Internal Medicine.
    • “Daw told MedPage Today that this decline in mental health was even greater than what she and her team were expecting to find. Recent research has focused on the impacts of the COVID-19 pandemic on mental health, but this study indicated that the downward population-level trends were happening before 2020.
    • “This is not just a pandemic story — it’s much broader than that,” Daw said. “This study helps us expand our thinking about when we should be caring about the health of mothers, and in pointing out that it is well beyond the perinatal period.”
  • and
    • “For patients with major depression, there was a clinically meaningful but not statistically significant improvement in the primary endpoint with 20-mg azetukalner.
    • “There were significant improvements in secondary endpoints.
    • “A phase III trial of azetukalner in major depressive disorder is now underway.”
  • The McKinsey Health Institute discusses how “the advent of weight management drugs such as GLP-1s have brought the treatment of obesity to the forefront of public attention, provoking a larger opportunity to work toward metabolic health for all.”

From the U.S. healthcare business front,

  • HHS’s Agency for Healthcare Research and Quality notes,
    • “In 2022, the top 1 percent of people ranked by their healthcare expenditures accounted for 21.7 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “People with the top 1 percent of expenses had an average of $147,071 in healthcare expenditures in 2022, which was lower than in 2021.
    • “People ages 65 and older and non-Hispanic Whites were disproportionately represented in the above median expenditure tiers.
    • “Ambulatory events, inpatient stays, and prescribed medicines each accounted for about 30 percent of healthcare expenses for people with the top 5 percent of expenses.
    • “Over three-quarters of expenses for people with the top 5 percent of expenses were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 75.1 percent had two or more of the AHRQ-designated priority conditions.”
  • MedCity News tells us,
    • “Most large employers plan to uphold their well-being benefits in 2025 even though they’re facing increasing healthcare costs and global economic headwinds, according to a recent survey from the Business Group on Health.
    • “The Business Group on Health is a nonprofit advocacy organization for large employers. The survey included responses from 131 employers that employ 11.2 million people across the world. Conducted in January and February, it follows another Business Group on Health survey that projected healthcare costs to rise nearly 8% in 2025, the highest increase in over a decade.
    • “The new survey found that 73% of employers plan to maintain their well-being programs in 2025, while 20% will be expanding their programs. The remainder will either decrease their well-being programs or are unsure.” 
  • Fierce Healthcare informs us,
    • “Customer satisfaction with health plans is on the decline, and the gap between the highest and lowest performers is getting wider, according to a new report.
    • “J.D. Power released its annual study looking at consumers’ attitudes toward commercial health plans, which found that the average satisfaction score for this market is 563 on a 1,000-point scale. But there is notable variation in scores based on geography and plan, with a high of 594 and a low of 523.
    • “The J.D. Power report said this means plan members in different parts of the country are having different experiences and finding varied value in their coverage.
    • “Member experience is a critical differentiator for employers and plan sponsors, with 20% of employers saying they switched plans due to low satisfaction among employees. Plans that separate themselves from the pack have invested in engagement, education and service, according to the study.”
  • STAT News lets us know,
    • “A new digital health care marketplace, launched last week, has a good amount of Amazon in its DNA. General Medicine, with $32 million in funding, came out of stealth with three former Amazon employees as co-founders and investors, a business model that could compete with Amazon’s One Medical — and behind the scenes, a current senior Amazon executive. 
    • “The former employees, including the founders of PillPack — the pharmacy company that Amazon bought in 2018 for about $750 million and grew into Amazon Pharmacy — bill General Medicine as a “one-stop shop for expert care” that connects patients to its own telehealth medical practices and to outside care. Sunita Mishra, Amazon Health Services’ chief medical officer, is the physician owner of one of those practices and advised the company early on, General Medicine and Mishra confirmed.”
  • Modern Healthcare reports,
    • “ChristianaCare plans to assume operations of five Crozer Health outpatient facilities in Pennsylvania after submitting the highest bid of $50.3 million. 
    • “The auction was held as Prospect Medical Holdings, Crozer’s parent company, seeks to sell the system’s assets after filing for Chapter 11 bankruptcy protection in January. The sale to Wilmington, Delaware-based ChristianaCare is subject to court approval, according to a Wednesday news release. 
    • “The sale includes two facilities in Glenn Mills, Pennsylvania as well as single facilities in Havertown, Broomall and Media, Pennsylvania. ChristianaCare said it is evaluating the programs and services offered at each location to determine what will be continued, expanded or revamped.”
  • Per Beckers Hospital Review,
    • “Secaucus, N.J.-based Hudson Regional Health, a four-hospital system, has been created as part of the final step in CarePoint Health’s bankruptcy exit.
    • “U.S. Bankruptcy Judge Kate Stickles approved the plan April 17, which went into effect May 22. The system comprises Secaucus-based Hudson Regional Hospital, Jersey City-based Christ Hospital, Hoboken (N.J.) University Medical Center and Bayonne (N.J.) Medical Center, and more than 70 affiliated locations, according to a May 27 Hudson Regional Health news release shared with Becker’s.”
  • “and provides a list of ten new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Tuesday Report

David Ermer–ACA, AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • Today, the U.S. Office of Personnel Management released a list of its accomplishments during the Biden-Harris administration.
  • Here is a link to Andreessen Horowitz bio of Scott Kupor who is President elect Trump’s designee for OPM Director.
  • The Washington Post is maintaining a website outside its paywall providing comprehensive news on Mr. Trump’s nominations.
  • The Wall Street Journal reports,
    • “Two vaccine skeptics who had been advising Robert F. Kennedy, Jr. as he prepares to become health secretary have been sidelined by Trump transition officials, people familiar with the matter said, underscoring a split over immunizations in the “Make America Healthy Again” movement.
    • “Adviser Stefanie Spear and lawyer Aaron Siri had asked prospective administration hires about their beliefs around vaccines even if they were interviewing for posts that had little to do with immunizations, people familiar with the interviews said. Kennedy, whose hearings to lead the Department of Health and Human Services could start on Capitol Hill as early as next week, also lobbed questions related to inoculation, the people said.
    • “The questions were different from those asked in separate meetings with President-elect Donald Trump’s staff, according to some of the people. Trump’s team asked about topics traditionally important to conservatives, such as the size of government and deregulation.
    • “Siri is no longer advising the presidential transition, a transition spokeswoman confirmed, and people familiar with the matter said his vaccine stances played a role. Spear, who had told others she would be Kennedy’s chief of staff, was passed over for that post in favor of a veteran of the first Trump administration—in part because of her vaccine priorities and in part because of her lack of experience, according to people familiar with the matter.”
  • The No Surprises Act regulators, which group includes OPM, released FAQ 69 which concerns an important opinion from the U.S. Court of Appeals for the Fifth Circuit handed down October 30, 2024. The Court has not issued its mandate in the case while it considers the Texas Medical Association’s motion for rehearing and rehearing en banc. The FAQ also includes compliance advice about the No Surprises Act anti-gag clause.
  • Per a Federal Trade Commission news release,
    • “The Federal Trade Commission today published a second interim staff report on the prescription drug middleman industry, which focuses on pharmacy benefit managers’ (PBMs) influence over specialty generic drugs, including significant price markups by PBMs for cancer, HIV, and a variety of other critical drugs.
    • “Staff’s latest report found that the ‘Big 3 PBMs’—Caremark Rx, LLC (CVS), Express Scripts, Inc. (ESI), and OptumRx, Inc. (OptumRx)—marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent. Such significant markups allowed the Big 3 PBMs and their affiliated specialty pharmacies to generate more than $7.3 billion in revenue from dispensing drugs in excess of the drugs’ estimated acquisition costs from 2017-2022. The Big 3 PBMs netted such significant revenues all while patient, employer, and other health care plan sponsor payments for drugs steadily increased annually, according to the staff report.” 
  • STAT News adds,
    • “In response to the latest report, a CVS spokesperson wrote that “any proposed policy regulating PBMs should face a simple test: will this increase or decrease drug costs? Nearly all recently proposed ‘anti-PBM’ policies would ultimately increase U.S. drug costs and serve as a handout to the pharmaceutical industry. Instead of focusing on the impact to consumers and organizations that pay for prescription drugs, the FTC has prioritized comments from the conflicted pharmaceutical and pharmacy industries that would profit from a weakened PBM guardrail.”
    • “The company also argued it is “inappropriate and misleading to draw broad conclusions from cherry-picked” generic drugs. Between 2017-2022, specialty generic products have represented less than 1.5% of total spending on medicines by health plans contracted with CVS. In contrast, branded specialty products represent more than 50% of total spending.
    • “A spokeswoman for Cigna, which owns Express Scripts, wrote to say “this is another set of misleading conclusions based on a subset of medications that represent less than 2% of what our health plans spend on medications in a year — much like their first interim report that the FTC itself has already said is ‘limited’ and ‘tentative’. Nothing in the FTC’s report addresses the underlying cause of increasing drug prices, or helps employers, unions, and municipalities keep prescription benefits affordable for their members. We look forward to continuing to address the blatant inaccuracies in the Commission’s reports.”
    • “One Wall Street analyst maintained the FCC report does not tell the complete PBM story. TD Cowen analyst Charles Rhyee wrote in an investor note that “the fundamental issue with the FTC’s claims… is that they use only data on specialty generics, a small subset of the overall drug market – 0.9% of total drug spending – and is not representative of the value that the PBM industry delivers as a whole.”
  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration is announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package (FOP) nutrition label for most packaged foods. This proposal plays a key role in the agency’s nutrition priorities, which are part of a government-wide effort in combatting the nation’s chronic disease crisis. If finalized, the proposal would give consumers readily visible information about a food’s saturated fat, sodium and added sugars content—three nutrients directly linked with chronic diseases when consumed in excess.  
    • “The proposed FOP nutrition label, also referred to as the “Nutrition Info box,” provides information on saturated fat, sodium and added sugars content in a simple format showing whether the food has “Low,” “Med” or “High” levels of these nutrients. It complements the FDA’s iconic Nutrition Facts label, which gives consumers more detailed information about the nutrients in their food.” * * *
    • “Comments on the proposed rule can be submitted electronically to http://www.regulations.gov by May 16, 2025.”
       
  • The Wall Street Journal adds,
    • “It is unclear how the incoming Trump administration will view the rule. Robert F. Kennedy Jr., the prospective next head of U.S. health policy, is a critic of processed foods and has been outspoken about his view that U.S. food companies are partly to blame for sickening Americans.
    • “Consumer advocacy groups and public health organizations cheered the rule, though some said they hoped the Trump administration would consider labels similar to those adopted in other countries that bear more pointed warnings.
    • “Industry groups have warned the FDA that they could sue to challenge mandatory front-of-package labels. Such labels, they said, could threaten First Amendment rights—because companies could consider them a form of forced speech—and only Congress has the authority to require them.” 
  • The New York Times reports,
    • “Among both men and women, drinking just one alcoholic beverage a day increases the risk of liver cirrhosis, esophageal cancer, oral cancer and various types of injuries, according to a federal analysis of alcohol’s health effects issued on Tuesday.
    • “Women face a higher risk of developing liver cancer at this level of drinking, but a lower risk of diabetes. And while one alcoholic drink daily also reduces the likelihood of strokes caused by blood clots among both men and women, the report found, even occasional heavy drinking negates the benefits.
    • “The report, prepared by an outside scientific review panel under the auspices of the Department of Health and Human Services, is one of two competing assessments that will be used to shape the influential U.S. Dietary Guidelines, which are to be updated this year.”
  • Monica M. Bertagnolli, M.D., issued a statement on ending her tenure as NIH director January 17, 2025. The FEHBlog has enjoyed her Director’s blog entries.

From the public health and medical research front,

  • The U.S. Preventive Services Task Force today gave B grades to the following recommended preventive services:
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in women 65 years or older.”
    • “The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk for an osteoporotic fracture as estimated by clinical risk assessment.”
  • and an inconclusive grade to the following preventive service
    • “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.”
  • The USPSTF notes,
    • “This recommendation updates the 2018 USPSTF recommendation on screening for osteoporosis. In 2018, the USPSTF recommended screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years or older and in postmenopausal women younger than 65 years who are at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool.45 For the current recommendation, the USPSTF has noted that screening can include DXA BMD, with or without fracture risk assessment. The current recommendation is otherwise generally consistent with the 2018 recommendation.”
  • The Journal of the American Medical Association expands on this USPSTF note in an editorial comment.
    • “At first glance, the updated US Preventive Services Task Force (USPSTF) Recommendation Statement on osteoporosis screening1 appears nearly identical to the previous 2018 statement, especially regarding the recommendation for universal screening in women 65 years or older and insufficient evidence to support a recommendation for or against screening in men. However, subtle revisions to the 2018 recommendation2 may result in substantive changes in screening of younger postmenopausal women in clinical practice. While a B recommendation for higher-risk postmenopausal women younger than 65 years is common to both statements, the 2018 statement recommended assessing risk of osteoporosis in these women using a formal clinical risk assessment tool, whereas the 2024 Recommendation Statement1 recommends screening those at increased risk for an osteoporotic fracture as estimated by clinical risk assessment. Additionally, the screening test for both younger and older postmenopausal women in the 2018 recommendation is specified broadly as bone measurement testing. By contrast, the 2024 statement is more specific and defines screening as central (hip or lumbar spine) dual-energy x-ray absorptiometry (DXA) bone mineral density (BMD) testing with or without fracture risk assessment.
    • “In postmenopausal women younger than 65 years, osteoporosis screening presents several challenges. While time is often limited and resources scarce in the overstretched primary care practice environment, the USPSTF recommends a 2-step process to identify women in this age group who warrant screening. The clinician first determines whether traditional osteoporosis risk factors such as low body weight or tobacco use are present. For women with 1 or more risk factors, the USPSTF then advises risk assessment with a clinical risk assessment tool (eg, the Osteoporosis Self-Assessment Tool [OST], the Osteoporosis Risk Assessment Instrument [ORAI], or the Fracture Risk Assessment Tool [FRAX]) calculated without BMD information to further select women who warrant BMD testing. Primary care clinicians should be aware that the OST and ORAI were designed to identify osteoporosis (BMD T score ≤−2.5), while FRAX was developed to estimate 10-year absolute probabilities of hip and major osteoporotic fracture. Use of the OST or ORAI entails a simple calculation with few inputs (e.g., the OST is based on age and weight alone), whereas use of FRAX requires entering information on 11 clinical risk factors into a web-based algorithm. Table 2 in the Recommendation Statement1 provides “frequently used thresholds for increased osteoporosis risk” for OST (score <2) and ORAI (score ≥9), indicating that these thresholds identify women for whom central DXA BMD testing is suggested. In contrast to the 2011 and 2018 recommendations, the 2024 USPSTF Recommendation Statement1 does not suggest a specific FRAX threshold to define increased osteoporosis risk.
  • Per a National Cancer Institute news release,
    • “Feeding fructose to lab animals with cancer made their tumors grow faster, a new study has shown. But the tumors didn’t directly consume fructose, the researchers found. Instead, the liver converted it into a type of fat that cancer cells gobbled up.
    • “Studies have suggested that diets containing excess fructose—which is found in high-fructose corn syrup and table sugar—can help tumors grow. But how this common dietary sweetener might do so has been a bit of a mystery. The researchers believe their study provides some important answers. 
    • “The NIH-funded study, published December 4 in Nature, showed that several types of cancer cells lacked the enzyme needed to use fructose directly. However, liver cells have the necessary enzyme, called KHK, and used it to convert fructose into fats called lipids. 
    • “The findings could open up a new avenue for potential cancer treatments, said the study’s senior researcher, Gary Patti, Ph.D., of Washington University in St. Louis. A drug that blocks the KHK enzyme slowed fructose-fueled tumor growth in mice, the scientists showed.”
  • The National Institutes of Health released an NIH research matters bulletin concerning “Cancer prevention and screening | Improving flu vaccines | LDL structure.”
  • AP reports,
    • “A group of global experts is proposing a new way to define and diagnose obesity, reducing the emphasis on the controversial body mass index and hoping to better identify people who need treatment for the disease caused by excess body fat. 
    • “Under recommendations released Tuesday night, obesity would no longer be defined solely by BMI, a calculation of height and weight, but combined with other measurements, such as waist circumference, plus evidence of health problems tied to extra pounds. 
    • “Obesity is estimated to affect more than 1 billion people worldwide. In the U.S., about 40% of adults have obesity, according to the U.S. Centers for Disease Control and Prevention. 
    • “The whole goal of this is to get a more precise definition so that we are targeting the people who actually need the help most,” said Dr. David Cummings, an obesity expert at the University of Washington and one of the 58 authors of the report published in The Lancet Diabetes & Endocrinology journal.”
  • Per MedPage Today,
    • “Integrating smoking cessation into a lung cancer screening program had the biggest benefit for patients who wanted to quit, a randomized trial showed.
    • “Self-reported tobacco abstinence was greater at both 3 and 6 months with higher levels of integration of smoking cessation assistance in the lung cancer screening program, reported Paul Cinciripini, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA Internal Medicine.”
  • and
    • “Antiviral drugs commonly used to treat non-severe influenza appeared to have little or no effect on key clinical outcomes, except for baloxavir (Xofluza), according to a systematic review and meta-analysis of 73 randomized trials.”

From the U.S. public health front,

  • STAT News adds,
    • “Since society rebounded from the pandemic, Teladoc Health has gone from a soaring rocket ship considered an emblem of the potential of health tech to a cautionary tale about overblown hype. Its telehealth services are now viewed by many as an interchangeable commodity in a crowded market.
    • “In his first prominent public appearance as CEO of the virtual care giant, Chuck Divita showed up [at the JPM Conference] and played the part — promising growth and stability and reminding investors of the company’s strong foundation.”
  • Beckers Hospital Review points out,
    • Eli Lilly is leading a push with other pharmaceutical companies to request a pause in the Biden administration’s drug pricing negotiations, even as officials prepare to release a new list of medications to be targeted for price reductions, Bloomberg reported Jan. 13. 
    • Speaking at the JPMorgan HealthCare Conference in San Francisco, Eli Lilly CEO Dave Ricks emphasized the need for changes to the Inflation Reduction Act before additional drugs are included in the program. 
  • MedCity News relates, “Nvidia announced four new partnerships focused on scaling AI models across the healthcare industry. The company is teaming up with Mayo Clinic, Illumina, IQVIA and Arc Institute” at JPM Conference.
  • BioPharma Dive lets us know,
    • “Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on 2023’s total but less than what it had estimated in October.
    • “Third quarter sales of Mounjaro and Zepbound, its GLP-1 drugs for diabetes and obesity, were below Wall Street analysts’ expectations at $3.5 billion and $1.9 billion, respectively. CEO David Ricks said GLP-1 market growth was slower than the company anticipated.
    • “Shares of the Indianapolis-based company fell by as much as 8% in morning trading, shaving tens of billions of dollars from its market valuation. Since hitting a high of $960 apiece in late August, shares have tumbled in value by about one-fifth as Zepbound sales have fallen short of forecasts.”
  • McKinsey & Company explains “How healthcare entities can use M&A to build and scale new businesses.”

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • This evening, the House of Representatives turned down the President-elect approved, 121-page long version of the Continuing Resolution this evening. The Wall Street Journal adds that “Talk circulated among lawmakers about a possible weeklong funding extension, which would push the shutdown deadline past Christmas. But that too would need bipartisan support to get through the Senate.” The current CR funding the federal government expires at 12:01 AM on December 21.
  • Govexec informs us,
    • “The House passed a compendium of veterans care proposals, packaged into a single bill, on Monday, sending it to the president’s desk in the waning days of the congressional session. 
    • “The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (S.141) — which provides the Veterans Affairs Department with everything from community care improvements to expanded home care and educational assistance benefits — cleared the chamber in a 382-12 vote Monday night after previously passing the Senate by unanimous consent on Dec. 12.
    • “The legislation serves as an omnibus package of previous House and Senate bills designed to improve VA community care offerings, quality care standards and other programs, while offering benefit increases for veterans and some providers. 
    • “We worked hard to craft this legislation to put veterans – not government bureaucracy – at the core of it,” said House Veterans Affairs Committee Chairman Mike Bost, R-Ill., in a statement. “The Dole Act will do that by expanding economic opportunities, simplifying the disability claims process, reforming services for aging veterans, opening more doors for mental health support and a lot more.”
  • Federal News Network lets us know,
    • “Federal agencies will be closed on Tuesday, Dec. 24, President Joe Biden announced, giving federal employees an extra day off the day before Christmas.
    • “The president made the announcement via an executive order that he signed Thursday.
    • “All executive departments and agencies of the Federal Government shall be closed and their employees excused from duty on Tuesday, December 24, 2024, the day before Christmas Day,” the executive order states.”
  • Modern Healthcare reports,
    • “A mandatory hospital payment model finalized this year by the Centers for Medicare and Medicaid Services could make earnings uncertain for providers, researchers said.
    • “Under the Transforming Episode Accountability Model, or TEAM, hospitals could lose out on an average of $500 per episode of care covered in the model, according to a December report from the Institute for Accountable Care. But the forecast results vary widely: Hospitals in the Minneapolis-St. Paul region could gain an average of $900 per episode of included care, the report said, while Denver providers stand to lose $1,300 per episode, on average. 
    • Beginning in 2026, TEAM sets 30-day episode-based payments for lower-extremity joint replacements, femur fracture surgeries, spinal fusions, coronary artery bypass grafts and major bowel procedures. CMS will set bundled payments for these services based on regional benchmarks. In other words, hospitals will need to reduce spending for select care to a threshold set by their neighbors, or risk having to make up the difference.  
    • “It creates a really strong incentive” to manage costs, said Rob Mechanic, executive director of the Institute for Accountable Care, an independent nonprofit initially funded by the National Association of ACOs. On the flip side, he said, the regional benchmarks mean hospitals can significantly reduce their costs but still lose money.
    • The government selected 741 hospitals to participate in the five-year model, which gives safety-net hospitals extra time to prepare before taking on downside risk. Since the model is mandatory, hospitals can’t opt out. Ambulatory surgical centers are not included. According to the IAC report, the covered services represent about 15% of Medicare revenue, on average, for participating hospitals.

From the judicial front,

  • The Wall Street Journal reports,
    • “Federal prosecutors charged ex-Ivy Leaguer Luigi Mangione with murder and stalking Thursday for the Dec. 4 shooting of UnitedHealth executive Brian Thompson, alleging he was arrested with a notebook stating an intent to “wack” the CEO of an insurance company.” * * *
    • “The latest charges, brought by the Manhattan U.S. attorney’s office, mean federal prosecutors could pursue a death-penalty case against him.” * * *
    • The new federal charges capped a whirlwind day that began in Pennsylvania, where Mangione agreed at a hearing to waive his right to contest his transfer to New York. He had been detained in Pennsylvania since his arrest last week.”

In Food and Drug Administration News,

  • Healthcare Dive relates,
    • “The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage,
    • “The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker, found itself unable to meet skyrocketing demand.
    • “However, the FDA won’t take enforcement action against compounding pharmacies until early next year, a grace period the agency said is to “avoid unnecessary disruption to patient treatment.”
  • Per STAT News,
    • “Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval for a therapy that treats patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats, setting the stage for the company to kick off the first solo drug launch in its 35-year history.
    • “The treatment, Tryngolza, also known by its scientific name of olezarsen, was approved for patients with familial chylomicronemia syndrome, or FCS, on the basis of late-stage trial results showing the therapy lowered triglyceride levels and was generally safe. Patients on the drug were less likely to develop an inflamed pancreas, an excruciating and sometimes life-threatening complication.
    • “Ionis executives believe the drug could also help patients with more common forms of sky-high triglycerides and have ongoing trials aiming to show that. If the drug is approved for more common conditions, market analysts have forecasted that Tryngolza could bring in $1.8 to $2 billion in peak sales.”
  • and
    • “Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.
    • “Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects.
    • “They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
    • “The “healthy” claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition.”
  • The Wall Street Journal adds,
    • “Under the updated claim, eggs, nuts and seeds, olive oil and higher-fat fish such as salmon will now qualify to use the “healthy” claim. Examples of products that qualified as healthy under the original claim but not the updated one include fortified white bread, highly sweetened yogurt, and highly sweetened cereals.
    • The agency said it would work with interested parties to support use of the updated claim, adding it had entered a partnership with grocery-delivery company Instacart to help shoppers find products.
    • Both the original and updated claims have limits on saturated fat and sodium. The updated claim has a limit on added sugars, while ending the limit on total fat.

From the public health and medical research front,

  • The American Hospital News lets us know,
    • “Life expectancy in the U.S. grew an average of 10.8 months in 2023, to 75.8 years for men and 81.1 years for women, according to a report by the Centers for Disease Control and Prevention. The overall death rate declined by 6%.  
    • “The 10 leading causes of death were unchanged from 2022, with heart disease, cancer and unintentional injuries remaining the top three. COVID-19 dropped from fourth to 10th, which moved stroke up to fourth, followed by chronic lower respiratory diseases, Alzheimer’s disease, diabetes, kidney disease, and chronic liver disease and cirrhosis.”
  • Per Healio,
    • “As many as 15 million adults in the United States have a 10% or greater risk for heart failure, results of a research letter published in Annals of Internal Medicine showed.
    • “The majority of those at higher risk for heart failure (HF) had uncontrolled modifiable risk factors for the condition, including obesity and hypertension, according to the researchers.
    • “Identifying populations at such a risk, along with implementing prevention strategies, “has the potential for dramatic public health impact,” the researchers wrote.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Clinical trials are essential for advancing new treatments that improve patient care and lives. But far too many clinical trials face challenges in identifying and enrolling eligible trial participants. Now, an NIH-led team has introduced an artificial intelligence (AI) tool that promises to speed up the process of matching patients to clinical trials to help boost enrollment. They call it TrialGPT.
    • “As reported in Nature Communications, TrialGPT takes advantage of large language models, a type of AI that can generate human-like responses to questions and explanations familiar to users of ChatGPT. The research team adapted it for matching patients to thousands of possible clinical trials in a data-efficient and transparent way. While earlier studies have shown the potential for using this type of AI for answering clinical questions, designing clinical trials, and retrieving initial lists of potential trials, TrialGPT is the first end-to-end solution, generating a list of potential trials before more precisely matching and ranking them. The team’s preliminary testing of this tool suggests TrialGPT can achieve a high degree of accuracy while cutting the time required of clinicians for screening patients. * * *
    • “In a pilot user study conducted at NCI, the researchers compared patient-trial evaluations based on short summaries about six patients made by one medical expert with TrialGPT and another who made the same evaluation manually without TrialGPT. Both experts conducted evaluations with and without AI to account for any differences in their speed or skill. The study found that clinicians using TrialGPT could generate similarly accurate lists of trial options in 40% less time.
    • “More study is needed to assess TrialGPT’s practical application in real-world settings across diverse groups of patients. But these findings already show the remarkable potential of AI technology for connecting patients to relevant trial opportunities, with tremendous potential for speeding trial recruitment and treatment advances while giving clinicians more time for other tasks only humans can do, including caring for their patients.”
  • The National Heart, Lung and Blood Institute offers an update featuring the “latest research on hypertension, educational resources on blood donation, and more.”
  • The Wall Street Journal reports,
    • “Roche said a Parkinson’s disease experimental drug missed its primary goal in a mid-stage trial, the second setback this week for candidate treatments for the neurodegenerative condition.
    • “The update from the Swiss pharmaceutical giant came after Belgian peer said a similar drug candidate for Parkinson’s developed jointly with Novartis failed to meet key goals in a clinical trial.
    • “Roche said Thursday that its drug candidate, prasinezumab, didn’t delay progression of motor symptoms in the trial, which included early-stage Parkinson’s patients, to an extent considered statistically significant.
    • “However, the company said the drug did show potential clinical efficacy, as well as positive trends on several other goals of the trial and was well tolerated. Roche will continue to evaluate the data and work together with health authorities to decide on next steps, it said.”
  • Per BioPharma Dive,
    • “Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence.
    • “In a statement, Merck said it will end development of two experimental cancer drugs that are currently in late-stage testing. One, called vibostolimab, is aimed at a target called TIGIT. The other, favezelimab, homes in a protein named LAG-3. Both were being evaluated in combinations with Keytruda and have been touted by Merck as a way to extend Keytruda’s market advantage beyond 2028, when its main U.S. patent will expire.”

From the U.S. healthcare business front,

  • The Wall Street Journal explores the question “Why Are Americans Paying So Much More for Healthcare Than They Used To?”
    • “National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services. 
    • “Total spending on healthcare goods and services, everything from prescription drugs to back surgeries, accounted for 17.6% of gross domestic product, a measure of goods and services produced by the U.S. economy.
    • “The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022. It came as pandemic federal funding for the healthcare sector expired and private health insurance enrollment increased. More people with insurance led to increased demand for medical procedures, and spending on hospital care grew at the fastest pace since 1990. Spending on drugs also rose, including for medications to treat diabetes and obesity.  
    • “A full 92.5% of Americans were covered by insurance last year, and 175.6 million, or just over half the population, got it through their employer, according to the government’s new annual data. 
    • “Over 65 million Americans are on Medicare, a government health-insurance program mainly for people ages 65 and older, and nearly 92 million are on Medicaid, a state-federal program for the low-income and disabled.”
  • STAT News relates,
    • “Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found.
    • “Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other medicines before insurers approve a prescription. The formularies are run by health plans, pharmacy benefit managers, and the U.S. Department of Veterans Affairs.
    • “But only 81% of the formularies scored well on a fourth criterion: cost-sharing, which is the portion of expenses paid by insured individuals. Although there is a caveat: This particular metric was based on a subset of just three drugs that were deemed to be fairly priced based on a cost-effectiveness assessment — the Mounjaro type 2 diabetes treatment, and the Wegovy and Qsymia obesity drugs.
    • “Meanwhile, transparency into coverage information for three gene therapies — Zynteglo for combating beta thalassemia, the Hemgenix hemophilia B treatment, and Roctavian for treating hemophilia A — remains less than optimal. Of the six formularies covering the therapies, 83% provided clinical criteria, cost-sharing information was only available in two or three, and none provided site of care information.”
  • Per Fierce Healthcare,
    • “Tech platform Uno Health is rolling out a self-service guide that shows users financial savings they could be eligible to obtain.
    • “The tool boasts of its ability to save the average user $4,500 a year after asking just a few questions. It is designed to improve accessibility and simplify the application process for everything ranging from federal and state health programs, heating bills, phone and internet services and the Supplemental Nutritional Assistance Program.
    • ‘These programs and benefits can be difficult for individuals to sift through, potentially leaving hundreds, or thousands, of dollars on the table if they do not enroll. Uno Health CEO Anna de Paula Hanika, formerly at Clover Health and Google, says the tool is an encapsulation of the company’s broader offerings.
    • “She said at least 50% of Medicare members are eligible for, but not enrolled in, other financial assistance programs. That figure increases to nearly 90% for Medicaid members. Unused benefits strain health programs and insurers.”

Midweek Update

David Ermer–Congress, FDA, Medical / Rx research, NIH, No Surprises Act–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • MedPage Today tells us,
    • “A bipartisan group of House members introduced a bill Tuesday that would reverse a proposed 2.8% Medicare Physician Fee Schedule payment cutopens in a new tab or window and give physicians a raise equivalent to half of the increase in the Medicare Economic Index (MEI), a measure of healthcare inflation.
    • “America’s physicians are at a breaking point and access to high-quality, affordable care is at risk for millions of Medicare patients,” Rep. Greg Murphy, MD (R-N.C.), one of the bill’s co-sponsors, said in a statement. “When a physician sees a Medicare patient, they do so out of the goodness of their heart, not because it makes financial sense … Unfortunately, reimbursements continue to decline, putting immense pressure on doctors to retire, close their practices, forgo seeing new Medicare patients, or seek a less efficient employment position. This bipartisan legislation would stop yet another year of reimbursement cuts, give them a slight inflationary adjustment, and protect Medicare for physicians and patients alike.”
  • Roll Call lets us know,
    • ​”With all eyes on next week’s elections, appropriations battles are simmering on the back burner for Congress. But lawmakers won’t have long to make some tough decisions when they return starting on Nov. 12 for the lame-duck session.
    • “The priorities are twofold: first, passing an emergency relief package after two major hurricanes battered the Southeast, compounding pent-up demands for disaster aid going back to last year. Second, congressional leaders need to figure out what to do about funding the government beyond the stopgap law’s Dec. 20 deadline.
    • ‘The current betting is that there simply won’t be enough time in the five weeks of session remaining to strike the deals needed to put together thousands of pages of text fleshing out a dozen full-year fiscal 2025 spending bills. Top Democrats and appropriators on both sides of the Capitol will push that option, but without GOP leadership buy-in, it’s very unlikely.”
  • Today the U.S. Court of Appeals for the Fifth Circuit handed a loss to the Texas Medical Association (TMA) in the No Surprises Act cases.
    • The Court summarized its holdings as follows
      • “We conclude that the provisions of the Rule related to QPA calculations are lawful and therefore REVERSE the district court’s holdings as to those provisions. We further conclude that the Rule’s deadline provision is unlawful and therefore AFFIRM the district court’s holding as to that provision. Finally, we conclude that the Rule’s disclosure requirements are lawful and therefore AFFIRM the district court’s holding as to those provisions.”
    • The first and third holdings are the TMA loss.  Last December, CMS implemented the district court’s QPA calculation decision in its NSA guidance.  The FEHBlog imagines that CMS may reverse that December 2023 guidance soon.
    • The second holding means that health plans must pay or deny an NSA claim within 30 calendar days after receipt. The clean claim consideration was rejected by the district court and the court of appeals. 

From the public health and medical research front,

  • The Washington Post reports,
    • “The bird flu outbreak in dairy cows has spread to at least one pig on a backyard farm in Oregon, the first detection of the H5N1 virus in swine in the United States, the U.S. Department of Agriculture said Wednesday.
    • “The discovery is particularly concerning to scientists and public health officials because pigs can become coinfected with bird and human viruses, allowing genes to swap to form a new, more dangerous virus that can more easily infect humans.
    • “Bird flu was first detected in poultry on the noncommercial farm, the Oregon agriculture department said Friday. The USDA’s National Veterinary Services Laboratories confirmed that one of the farm’s five pigs was infected with the virus on Tuesday but did not publicize the discovery until Wednesday.” * * *
    • “Once an avian virus like H5N1 gets into a pig, it can mix with other viruses — a process known as reassortment — and pick up the ability to grow better and adapt to make humans sicker, Webby said. At least 31 people have been sickened in the current bird flu outbreak, all with mild symptoms.
    • ‘Animals on the farm are not part of the commercial food supply, the USDA said. The discovery of bird flu in the swine has no impact on the safety of the nation’s pork supply.
    • “The farm’s small size gives the virus less opportunity to spill into humans, experts said.”
  • The New York Times informs us,
    • “The blockbuster drug semaglutide, sold as Ozempic for diabetes and as Wegovy for weight loss, now has a new proven benefit: It markedly soothed knee pain in people who are obese and have moderate to severe osteoarthritis, according to a large study.
    • “The effect was so pronounced that some arthritis experts not involved with the clinical trial were taken aback.
    • “The magnitude of the improvement is of a scope we haven’t seen before with a drug,” said Dr. Bob Carter, deputy director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “They had an almost 50 percent reduction in their knee pain. That’s huge.”
    • “Dr. David T. Felson, an arthritis expert and professor of medicine at Boston University School of Medicine, said the study “changes the landscape,” adding that the pain reduction is greater than anything that can be achieved short of knee replacement surgery.”
  • and
    • “For decades, people with failing heart valves who nevertheless felt all right would walk out of the cardiologist’s office with the same “wait and see” treatment plan: Come back in six or 12 months. No reason to go under the knife just yet.
    • “A new clinical trial has overturned that thinking, suggesting that those patients would be much better off having their valves replaced right away with a minimally invasive procedure.
    • The trial, whose results were published this week in The New England Journal of Medicine, could change the way doctors treat severe aortic stenosis, a narrowing of the valve that controls blood flow from the heart. The disease, which has a prognosis worse than that of most cancers, afflicts more than 3 percent of people ages 65 and older. It is expected to become more common as people live longer.
    • “Replacing people’s heart valves, even if they were not yet experiencing any ill effects, appeared to roughly halve their risk of being unexpectedly hospitalized for heart problems over at least two years, the trial found.”
  • The Wall Street Journal adds,
    • “It is hard to mend a broken heart, but in a few years doctors might be able to do essentially that.
    • “Scientists are closing in on ways to help patients grow new heart muscle after a heart attack, as well as new lung tissue to treat fibrosis, corneas to erase eye pain and other body parts to gain a new chance at life.
    • “If the science works, it could represent a new approach to medicine: reversing rather than alleviating chronic illnesses.”
    • “The idea “is really to restore function to the organ such that the quality of life of that person is normalized,” says Peter Schultz, president and chief executive of Scripps Research, a nonprofit scientific institute in La Jolla, Calif., that is testing medicines to regenerate hearts, lungs and other organs.
    • “These treatments eventually might also be used to reverse the effects of aging, Schultz says. If they prove effective in people with disease, he says, they could be tested in healthy people to see if they can, say, “turn a 70-year-old heart into a 40-year-old heart.”
  • STAT News relates,
    • “An experimental Alzheimer’s therapy from Roche successfully cleared a protein that’s a hallmark of the disease from patients’ brains, the company reported Wednesday, adding to evidence that the drug shows promise.
    • “The data are from an early-stage trial and so far, Roche has not yet assessed whether there has been any corresponding change in cognitive function or disease progression. But U.S. regulators have in recent years approved similar medicines that can reduce levels of the protein, called amyloid, in patients’ brains and that in trials modestly slowed the worsening of Alzheimer’s.
    • “What’s more, the early findings of Roche’s treatment, an antibody called trontinemab, suggest it could be safer than some of the other amyloid-clearing treatments, although larger studies would need to confirm that. In particular, there have been comparatively few cases of an issue called ARIA, a type of brain swelling or bleeding, that has been seen with the other antibodies and that has led regulators in some parts of the world to take negative views of the existing drugs.”
  • Beckers Hospital Review alerts us,
    • “A recent study revealed a 17.5% increase in asthma-related hospitalizations in the three months following the announcement that GSK would discontinue the widely used asthma medication Flovent, and 24.1% in the following three to six months, ABC News reported Oct. 30. 
    • “The research, conducted by EPIC Research, analyzed data from over 3 million patients and highlighted the potential risks associated with the switch to alternative medications. 
    • ‘Five-year-old Burton Hayes, whose asthma was previously well managed on Flovent, faced significant health challenges after his mother was forced to switch his medication, ABC News reported. Reports indicated a sharp rise in asthma exacerbations among patients following the discontinuation, leading to an increase in emergency room visits and hospital admissions. 
    • “The decision to halt Flovent’s production came after a Federal Trade Commission warning about its patent. To comply with regulatory changes and avoid potential financial penalties, GSK shifted to an authorized generic, fluticasone propionate. However, many patients are finding that the new generic is not covered by insurance, complicating access, according to the ABC News report.”
  • CIGNA points out “fifteen stats illustrating cancer’s impact on people, employers, and health care costs.”
  • Per an NIH press release,
    • “New insights from multiple studies provide critical information on how cancer tumors develop, spread, and respond to treatments. The 10 studies from the Human Tumor Atlas Network (HTAN), a National Institutes of Health (NIH)-funded Cancer Moonshot℠ initiative to construct three-dimensional maps of human tumors, will be published Oct. 31, 2024, across several Nature journals.
    • “Several studies explore the role of the tumor microenvironment and the immune system in promoting the spread of cancer and its resistance to treatment. Three studies map the trajectory of precancerous colorectal tissues toward cancer by measuring the contributions of multiple molecular and cellular events. Multiple new HTAN papers describe the development of innovative single-cell technology and analysis platforms. An accompanying research briefing by W. Kimryn Rathmell, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI), and Dinah Singer, Ph.D., NCI deputy director for scientific strategy and development, discusses the history, progress, and future of HTAN.
    • “Launched in 2018, HTAN constructs three-dimensional maps of human tumors that capture their molecular features and surrounding microenvironments over time. The work is being done by teams of investigators from research institutions across the country using a variety of technologies and computational approaches to study tumors at the single-cell level. This comprehensive, publicly available resource aims to help researchers better understand the development and progression of cancer to inform its prevention and treatment. The first tumor atlas studies from this initiative were published in 2020 and 2021.” * * *
    • “The collection page is available at https://www.nature.com/collections/fihchcjehc.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “Actions taken by Humana to weather tumult in the Medicare Advantage program appear to be bearing fruit. On Wednesday, the insurer reported better-than-anticipated third quarter results and modestly increased its 2024 earnings guidance after retaining more MA seniors than expected — and those members having higher risk scores, boosting reimbursement.
    • “Humana now expects to add 265,000 individual MA members this year, representing 5% growth, compared to its previous guidance of 225,000 new MA members.
    • “Despite the stronger membership, Humana doesn’t expect earnings growth in 2025 because of heavy investments the insurer plans to make to boost its MA stars — valuable quality ratings linked to plans’ revenue in the privatized Medicare program.”
  • Per BioPharma Dive,
    • “Eli Lilly’s seemingly inexorable growth hit a speed bump Wednesday, when the Indianapolis drugmaker reported earnings for the third quarter that missed Wall Street expectations and sent shares down sharply.
    • “Overall, revenue reached $11.4 billion between July and September, up 20% from the same period last year but higher by only 1% versus the second quarter and well below the consensus forecast of about $12.1 billion.
    • “Lilly’s sales and stock price have swelled on surging demand for the company’s GLP-1 medicines Mounjaro and Zepbound, which it respectively sells for diabetes and obesity.
    • “The company has had difficulty meeting that demand, though, leading to shortages that have hampered the drugs’ availability. (In October, the Food and Drug Administration officially removed Mounjaro and Zepbound from its shortage list, but is now reconsidering that decision.)
    • “Compared to the third quarter last year, sales of the two drugs are significantly higher, respectively reaching $3.1 billion and $1.26 billion during the period. But both totals were lower than analysts expected and roughly flat compared to the second quarter.”
  • and
    • “All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped to wholesalers, the drugmaker confirmed Wednesday.
    • “One dose form or another of both drugs, which respectively treat diabetes and obesity, has been in shortage since March 2022, according to a database maintained by the Food and Drug Administration. The database was updated Wednesday to reflect the drugs’ new availability, although both remain listed.
    • “In an emailed statement, Novo cautioned that, “even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy.” The statement added that people seeking to fill a prescription may experience this “variability” regardless of whether a drug is actively in shortage.”
  • Per Fierce Pharma,
    • “It’s a new era for AbbVie. For the first time in years, the company has a new top sales driver as Skyrizi has overtaken Humira in quarterly sales.
    • “Humira heir Skyrizi has been slowly creeping up on the once-dominant Humira ever since biosimilar competition prompted the immunology king’s decline. With Skyrizi salesskyrocketing 50% to $3.2 billion during the third quarter, the drug took the sales crown from Humira, which has been trending down and generated $2.2 billion during the period.
    • “Skyrizi holds biologic share leadership in approximately 30 countries and boasts a “best-in-class profile” that presents a “very high bar” for rivals, AbbVie’s chief commercial officer Jeffrey Stewart said on the company’s third-quarter earnings conference call.
    • “After Skyrizi’s recent debut in ulcerative colitis, feedback and initial prescription trends have been “overwhelmingly positive,” Stewart added. The crowded ulcerative colitis market recently gained another competitor in Johnson & Johnson’s Tremfya, setting up a fierce fight for dominance between the pharma giants. However, Skyrizi has a leg up with its prior Crohn’s disease nod, which represents the second form of inflammatory bowel disease (IBD).”
  • Fierce Healthcare tells us,
    • “Online therapy company Talkspace grew its revenue 23% in the third quarter, bringing in $47.4 million, and turned last year’s net loss into a profit of $1.9 million.
    • “The company continues to expand its business with payers and employers and now covering 158 million people in-network and through Medicare/Medicare Advantage plans, an increase of 40% year-over-year, Talkspace announced in its third-quarter earnings report released Tuesday. As Talkspace grows, it is increasing access to virtual behavioral health services for seniors, teens and members of the U.S. military, exectives said.
    • “This past quarter marks Talkspace’s third consecutive quarter of adjusted EBITDA profitability. Adjusted EBITDA came in at $2.4 million in Q3, an improvement from a loss of $2.8 million a year ago and beating Wall Street analysts’ consensus estimate of $1.4 million.”
  • Beckers Payer Issues identifies “the investments 18 payer executives are most excited about.” Check it out.

Weekend update

David Ermer–Congress, Medical / Rx research, No Surprises Act, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Happy Labor Day!

From Washington, DC,

  • The Hill reminds us that Congress will return to Capitol Hill for on September 9 for “a three-week sprint, during which lawmakers will face key legislative deadlines and work to push their political messages before departing again for campaign season.”
  • Federal New Network points out,
    • “OMB issued its annual Circular A-11 update in late July and the 1,079-page tome is filled with dates and instructions for how agencies should put the final touches on their 2026 budget requests.
    • “Digging deeper into the primer, agencies will find an extensive treatise on everything from improving customer experience to managing federal real property to updated requirements for using evidence and evaluation in programs. * * *
    • OMB told agencies to prepare for a 3% civilian pay raise as part of their 2026 budget planning.
  • September is the month that OPM announces the next year’s FEHB maximum government contribution and FEHB plans can start sharing their premium news publicly. Back in the day, the announcement was known as the Labor Day press release. However, the announcement has slipped over the past 40 years to the end of the month. With the big Postal Service Health Benefits Program launch set for January 1, OPM may make the announcement earlier in September 2024. It will be interesting to see how FEHB and PSHB premiums compare to one another.
  • Bloomberg has an article about an 11th Circuit No Surprises Act case worth noting.  This air ambulance claim dispute case involves a situation where the IDR arbitrator ruled in favor of the insurer, Kaiser Permanente, and the provider has challenged the arbitration award in federal court. The provider lost at the district court level and has appealed to the 11th Circuit. Here are links to KP’s appellee brief and AHIP’s amicus brief. 

From the public health and medical research front,

  • Per a National Institutes of Health press release,
    • “Research supported by the National Institutes of Health (NIH) has found that measuring two types of fat in the bloodstream along with C-reactive protein (CRP), a marker of inflammation, can predict a woman’s risk for cardiovascular disease decades later. These findings, presented as late-breaking research at the European Society of Cardiology Congress 2024, were published in the New England Journal of Medicine.
    • “We can’t treat what we don’t measure, and we hope these findings move the field closer to identifying even earlier ways to detect and prevent heart disease,” said Paul M. Ridker, M.D., M.P.H., a study author and the director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston.”
  • The American Medical Association offers advice on how to encourage communities to control hypertension.
  • Fierce Pharma lets us know,
    • “With the heart failure (HF) patient population rapidly expanding, the timing is right for Bayer’s Kerendia (finerenone). The non-steroidal mineralocorticoid receptor antagonist (MRA) was approved three years ago for chronic kidney disease (CKD) associated with Type 2 diabetes but the bulk of its market potential lies with its ability to treat HF.
    • “Four weeks ago, the company revealed that it had scored a victory in the 3 FINEARTS-HF trial. Now Bayer is putting numbers to the claim, unveiling data from the trial that showed Kerendia reduced the risk of cardiovascular death, as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).
    • “Kerendia is the first non-steroidal MRA to meet a primary composite cardiovascular endpoint in a phase 3 trial investigating HF patients with a left ventricle ejection fraction (LVEF) of more than 40%, the company said.
    • “Bayer presented the data at the European Society of Cardiology (ESC) event, Sunday in London. The results also were published Sunday in the New England Journal of Medicine.
    • “It is important to remember that there have been very few medications that have demonstrated a definitive therapeutic benefit for patients with HFmrEF and HFpEF, so we believe these results provide new insights for health care teams and patients alike, especially given the reduction in clinical endpoints like death and hospitalization and improvements in patient-reported symptoms,” Alanna Morris, Bayer’s senior medical director of US Medical Affairs, explained in an email.”
  • The Washington Post and Consumer Reports suggest treatments for sleep apnea other than the CPAP machine.
  • The New York Times reports,
    • “[While] dialysis can prolong the lives of patients with kidney failure, * * * a new study published in the journal Annals of Internal Medicine analyzed data from a simulated trial involving records from more than 20,000 older patients (average age: about 78) in the Veterans Health Administration system. It found that their survival gains were “modest.”
    • How modest? Over three years, older patients with kidney failure who started dialysis right away lived for an average of 770 days — just 77 days longer than those who never started it.
    • “I think people would find that surprising,” said Dr. Manjula Tamura, a nephrologist and researcher at Stanford and a senior author of the study. “They would have expected a greater difference.”
  • The Wall Street Journal notes,
    • “A Sanofi experimental drug for multiple sclerosis delayed disability progression in a late-stage trial, but failed to reduce episodes of new or worsening symptoms compared to an existing treatment in other clinical studies.
    • “The French pharmaceutical company said Monday that results of the clinical trials for tolebrutinib, a drug candidate taken orally and being evaluated as a treatment of various forms of multiple sclerosis, will pave the way for discussions with regulators about potentially bringing the drug to market.
    • “Sanofi’s multiple sclerosis drug Aubagio lost patent protection in key markets last year and the company has been working on a new class of drugs to treat the neurodegenerative disease, which results in accumulation of irreversible disabilities over time. Sanofi sees disability accumulation as a significant unmet medical need for patients with the disease. * * *
    • “The company said the drug met the primary goal of a phase 3 trial by delaying disability progression in patients with non-relapsing secondary progressive multiple sclerosis, a type of the disease in which patients have stopped experiencing confirmed relapses—episodes of new or worsening symptoms—but their disability continues to increase over time.”

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, CMS, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Bloomberg reports,
    • “A federal judge ruled the US Federal Trade Commission can’t enforce its near-total ban on noncompete agreements that was set to go into effect next month, blocking an effort by the agency to make labor markets more competitive. 
    • “In a ruling Tuesday, US District Judge Ada Brown in Dallas sided with the US Chamber of Commerce and a Texas-based tax firm that sued to block the measure. The judge said the FTC lacked the authority to enact the ban, which she said was “unreasonably overbroad without a reasonable explanation.” 
    • “The ruling represents a significant blow for the FTC and further divides the judiciary over the regulator’s powers. A federal judge in Pennsylvania had previously sided with the FTC. The rule is likely to be headed for appellate review. Brown had previously delayed implementation of the ban, which was scheduled to take effect on Sept. 4.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicaid and Medicare Services Aug. 20 released a report presenting data on complaints and enforcement efforts by the agency concerning title XXVII of the Public Health Service Act, which includes both the surprise billing and price transparency provisions of the No Surprises Act. As of June 30, 2024, CMS received more than 16,000 complaints and closed 12,700 with 400 complaints with PHS violations. In total the agency reported over $4 million in restitution for closed cases. Top complaints against plan issuers include non-compliance with Quality Payment Amount requirements, late payment after independent resolution determination, and non-compliance with 30-day initial payment or notice of denial payment requirements. Top complaints against providers relate to surprise bills and good faith estimates.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), announced more than $1.4 billion in Ryan White HIV/AIDS Program funding for the HRSA AIDS Drug Assistance Program and related awards. This HRSA funding ensures that individuals with HIV who have low incomes receive lifesaving medication, quality HIV health care and essential support services. This announcement supports and advances the Biden-Harris Administration’s National HIV/AIDS Strategy.
    • “HRSA-supported AIDS Drug Assistance Programs pay for HIV medication, co-pays and co-insurance for HIV medication, and premiums for health insurance that covers HIV medication. This critical support helps individuals with HIV receive antiretroviral therapies, which help people reach viral suppression, meaning they cannot sexually transmit HIV and can live longer and healthier lives. Without access to lifesaving HIV medication provided by HRSA-supported AIDS Drug Assistance Programs, HIV medication could cost an individual more than $40,000 per year, putting it otherwise out of reach. HRSA supports critical HIV care and medication in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and six U.S. Pacific territories.”
  • Federal News Network tells us,
    • “The Postal Service is facing a potential “retirement wave,” its inspector general’s office warns, with nearly one in five of its employees now retirement-eligible, and more than half its workforce eligible to retire within a decade.
    • “The USPS OIG, in its latest report, found USPS experienced no significant shortage of career employees last year, despite a tight labor market in the U.S. and record-low unemployment rates.
    • “Between fiscal years 2019 and 2023, USPS grew its workforce by more than 8,000 employees — a more than 1% growth rate. The agency employs about 637,000 total workers.
    • “The agency, however, may also need to prepare for a large contingent of its workforce to retire.”

From the public health and medical research front,

  • ABC News reports,
    • “The number of births declined in the United States in 2023, ending two years of upticks during the COVID-19 pandemic, according to a new federal report.
    • “A report published early Tuesday by the Centers for Disease Control and Prevention’s National Center for Health Statistics showed there were 3,596,017 babies born in 2023.
    • “This is a decrease of 2% from the 3,667,758 babies born in 2022 and the 3,664,292 babies born in 2021.”
  • The AP informs us,
    • “Public health experts from some of the nation’s leading research institutions have deployed a massive medical trailer to rural parts of the South to test and survey thousands of local residents. The goal: to understand why the rates of heart and lung disease are dramatically higher there than in other parts of the U.S. 
    • “This rural health disadvantage, it doesn’t matter whether you’re white or Black, it hurts you,” said Dr. Vasan Ramachandran, a leader of the project who used to oversee the Framingham Heart Study — the nation’s longest-running study of heart disease. “No race is spared, although people of color fare worse.
    • “The researchers aim to test the heart and lung function of roughly 4,600 residents of 10 counties and parishes in Alabama, Kentucky, Louisiana and Mississippi while collecting information about their environments, health history and lifestyles. They are also giving participants a fitness tracker and plan to survey them repeatedly for years to check for any major medical events.”
  • The U.S. Preventive Services Task Force made the following final recommendation today:
    • For asymptomatic pregnant adolescents and adults:
      The current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency and iron deficiency anemia in pregnant persons.
      Grade: I statement
    • This recommendation aligns with the prior 2015 recommendation.
  • MedPage Today notes
    • “Researchers Challenge USPSTF’s Lung Cancer Screening Criteria — Alternate criteria based on years of smoking has higher sensitivity and specificity, study says.
  • Per Healio,
    • Messaging strategies led to higher support for breast cancer screening cessation [among older women].
    • Messages from multiple vs. one or no source led to higher intentions of screening cessation.
    • “One important contributor to overscreening is that patients have received pro-screening messages for many years from the media, the broader social environment and health care professionals. In contrast, there has been little messaging about the harms of overscreening, or that stopping screening may be appropriate for some women,” Eli Lilly’s LLY 3.05%increase; green up pointing triangle anti-obesity drug Zepbound significantly reduced the risk of Type 2 diabetes among people with excess weight and elevated blood-sugar levels in a new study.
    • The finding widens the list of additional health benefits beyond weight loss for a hot new crop of anti-obesity drugs. Prior studies have found that Novo Nordisk’s Wegovy reduces the risk of heart attacks and strokes, and Lilly’s Zepbound eases the severity of obstructive sleep apnea.  associate professor in the division of geriatric medicine and gerontology in the department of medicine at Johns Hopkins University School of Medicine, and colleagues wrote in JAMA Network Open. “Messaging strategies have been used successfully to reduce other unwanted health behaviors such as smoking but are an understudied approach to reduce overscreening.”
  • To top things off, the Wall Street Journal reports,
    • “Eli Lilly’s anti-obesity drug Zepbound significantly reduced the risk of Type 2 diabetes among people with excess weight and elevated blood-sugar levels in a new study.
    • The finding widens the list of additional health benefits beyond weight loss for a hot new crop of anti-obesity drugs. Prior studies have found that Novo Nordisk’s Wegovy reduces the risk of heart attacks and strokes, and Lilly’s Zepbound eases the severity of obstructive sleep apnea.  * * *
    • “In the study, weekly injections of Zepbound for more than three years reduced the risk of progression to Type 2 diabetes by 94%, compared with a placebo, among people with excess weight and prediabetes, Lilly said Tuesday.
    • “The drug also led to significant weight reduction at an average of between 15% and nearly 23%, depending on the dosage, compared with the 2.1% reduction in patients who received a placebo.
    • “Some of the benefits appeared to last, however, only as long as patients were taking the drug. During a 17-week off-treatment follow-up period, patients who discontinued Zepbound began to regain weight and had some increase in the progression to Type 2 diabetes. Including the 17-week off-treatment period, patients who took Zepbound in the study had an 88% reduction in the risk of progression to Type 2 diabetes compared with the placebo.”
  • Fierce Pharma adds,
    • “Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. While the agencies found no increased risk for the popular diabetes and obesity drug, a new study could fuel the debate.
    • “In a study recently published in the Journal of the American Medical Association (JAMA), researchers found a “significant disproportionality” for semaglutide-associated suicidal ideation compared with other medicines, particularly among patients who also use antidepressants. 
    • “No such link was found for Novo’s earlier-generation GLP-1 med, liraglutide, according to the team. The study was based on the World Health Organization’s (WHO’s) database of suspected suicidal and self-injurious adverse drug reactions.
    • “Branded as Wegovy, Ozempic and Rybelsus, Novo’s semaglutide medicines—and their liraglutide counterparts Victoza and Saxenda—all fall under the GLP-1 umbrella.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Epic is planning to deepen its relationships with health insurance companies, the electronic health record giant said at its annual user group meeting Tuesday.
    • “The EHR company is working with health systems and large insurers such as CVS Health subsidiary Aetna, Elevance Health and multiple Blue Cross and Blue Shield plans to streamline prior authorization requests and ease provider appeals to payers, Epic founder and CEO Judy Faulkner said during a keynote address. The event was held at Epic’s headquarters in Verona, Wisconsin.
  • The Business Group on Health announced,
    • “Projected health care cost trend jumped to almost 8% for 2025, the highest amount in more than a decade, according to Business Group on Health’s 2025 Employer Health Care Strategy Survey.
    • “The predicted surge in employer health care spending – actual health care costs have grown a cumulative 50% since 2017 – comes against a backdrop of inflation, heightened demand for expensive drugs such as GLP-1s, potentially curative but high-cost cell and gene therapies, and the ongoing burden of treating cancer and other chronic conditions.
    • “Employers are steadfast in their desire to provide comprehensive offerings to their workforces,” said Ellen Kelsay, president and CEO of Business Group on Health. “They continue to absorb much of the upticks in cost and remain keenly focused on lowering spending and improving outcomes and experiences for employees. However, the foreboding cost landscape has accelerated the need for bold transformation, and employers seek partners who will make that happen.”
    • “The Business Group survey, released today in Washington, D.C., also showed that pharmacy spending was largely responsible for the increased health care trend in 2023; that GLP-1s have created challenges for employers; and that while cancer and musculoskeletal conditions remained the top two cost drivers, this year saw more employers reporting cardiovascular conditions as the third costliest.
    • “The survey gathered data on a range of critical topics related to employer-sponsored health care for the coming year. A total of 125 large employers across varied industries, who together cover 17.1 million people in the United States, completed the survey between June 3, 2024, and July 12, 2024.”
  • Per Fierce Healthcare,
    • “Mass General Brigham’s operating income slipped to $47 million for the quarter ended June 30 despite a 7% year-over-year increase in total operating revenue, the major nonprofit system reported last week.
    • “The fiscal third-quarter numbers, which reflect a 0.9% operating margin, follow the prior year’s $69 million operating income and 1.4% operating margin.
    • “When including nonoperating items such as investment income, Mass General Brigham logged a net income of $277.5 million, also down from the third quarter of 2023.
    • “The Massachusetts system is showing a slight year-over-year improvement across the first months of its 2024 fiscal year, having turned the prior year’s $5 million loss into a $41 million operating income (0.3% operating margin, not inclusive of $118 million of onetime revenue tied to prior year healthcare provider activity).”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved a new combination drug regimen from Johnson & Johnson to treat a common type of advanced lung cancer with certain genetic mutations.
    • “J&J’s Rybrevant is now cleared for use with another drug called Lazcluze in people with previously untreated non-small cell lung cancer that’s metastasized or advanced locally. Only people with specific mutations in a gene known as EGFR are eligible for treatment.
    • “The approval is based on results from a study that compared the combination to AstraZeneca’s lung cancer drug Tagrisso. In a statement, J&J described the new treatment as the first chemotherapy-free regimen that’s demonstrated superiority to Tagrisso in this setting.”
  • Per MedTech Dive,
    • “Johnson & Johnson has agreed to acquire V-Wave, the maker of an implantable device to treat heart failure, in a deal worth up to $1.7 billion.
    • “J&J will pay $600 million upfront, plus potential additional payments up to about $1.1 billion if regulatory and commercial milestones are met, the company said Tuesday. J&J expects the acquisition to close before the end of the year.
    • “V-Wave’s device, known as the Ventura Interatrial Shunt, is designed to reduce elevated left atrial pressure in people with congestive heart failure by creating a shunt between the left and right atrium. It received the Food and Drug Administration’s breakthrough device designation in 2019 and Europe’s CE mark in 2020. J&J said the device could be the first of its kind to reach the market.”