Tuesday report

HSA

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.”

Monday update

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

Tuesday report

David Ermer–Congress, HSA, Medical / Rx research, NIH, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Senate passed President Trump’s tax-and-spending bill [(HR 1)] by a 51-50 vote, with Vice president JD Vance breaking the tie.
    • The bill extends tax cuts, reduces Medicaid spending and increases funding for defense and border enforcement.
    • The House will now vote on the bill, facing internal GOP divisions over Medicaid changes and spending cuts.
  • House of Representatives will convene for legislative business at 9 am on Wednesday morning. The House Rules Committee met about the Senate amendment to HR 1 this afternoon.
  • Reuters tells us,
    • “President Donald Trump‘s administration on Tuesday reported having 2.3 million people on federal payrolls in March, almost unchanged from prior months despite the Republican’s efforts to shrink the size of government.
    • “The Office of Personnel Management, which functions as the HR department for the federal government, published figures on Tuesday on hiring and firing across thousands of government offices, with growth in some areas of government largely canceling out cuts elsewhere.
    • “Overall, the number of federal jobs – excluding postal workers and the military – was down about 23,000 from September, the last published report on overall staffing levels.
    • “To be sure, the numbers are only through March and Trump, who took office in January, has continued efforts to shrink the federal workforce. The administration has signed deals, for example, with at least 75,000 federal workers, agreeing to pay them for several months before they resign. A spokesperson at the Office of Personnel Management said hundreds of thousands of such workers will drop off federal payrolls in October.”
  • NextGov/FCW adds,
    • “The Office of Personnel Management plans to update FedScope, the government’s portal for statistics on the federal civilian workforce, it announced on Tuesday.
    • “In the coming months, OPM will launch a newly designed platform featuring interactive visuals, detailed datasets, and tools tailored to answer the most frequently asked questions about federal employment,” OPM said in a press release, previewing a fall 2025 update to the website. 
    • “A banner on the website also hints at more regular updates, saying that “beginning this fall, Federal Workforce Data will be routinely available in an easily accessible, reimagined format.”
  • Mercer conveniently summarizes the 2026 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) along with the 2024 and 2025 figures.
  • The Justice Department and the Federal Trade Commission held listening sessions yesterday and today about lowering drug prices for Americans through competition.

From the judicial front,

  • The Washington Examiner informs us,
    • “The Supreme Court on Monday [June 30] wiped away a series of lower court decisions that favored transgender litigants, sending the cases back to the appellate level for reconsideration in light of the court’s recent ruling upholding a Tennessee ban on puberty blockers and hormone therapy for minors.
    • “The 6-3 decision in United States v. Skrmetti, handed down June 18, marked a major victory for state-level efforts to restrict transgender procedures for minors. The ruling has now prompted the justices to vacate multiple decisions from lower courts in cases involving health benefits and birth certificate policies for people who identify as transgender.
    • “In an order list issued Monday morning, the high court overturned appellate rulings that previously blocked state-level bans or coverage restrictions for transgender-related care in North Carolina, West Virginia, Idaho, and Oklahoma. The move means each case must now be reheard under the legal standard articulated in the Skrmetti ruling, which found no violation of the Constitution’s equal protection clause in a ban on medical treatments for minors who identify as transgender.
    • “The high court also declined to take up a separate appeal from Kentucky, where families challenged the state’s similar law banning transgender procedures for minors.”
  • The Court also denied reviewing two Flower court decisions holding that the Tennessee law did not violate the 14th Amendment’s due process of law clause.
    • S. Ct. Case No. 23-466 L. W., ET AL. V. SKRMETTI, JONATHAN, ET AL.
    • S. Ct. 23-492 DOE, JANE, ET AL. V. KENTUCKY
  • Fierce Healthcare lets us know,
    • “Mass layoffs and reorganization of the Department of Health and Human Services (HHS) stalled out in federal court, as a Rhode Island federal judge sided with a coalition of 19 state attorneys general against subagencies Tuesday.
    • “Filed in early May, the Democratic attorneys general argued recent actions signed off upon by HHS leadership were unconstitutional and illegal, reported Fierce Biotech. The judge agreed, granting a preliminary injunction to halt the changes. The government must file a status report by July 11.
    • “The Executive Branch does not have the authority to order, organize, or implement wholesale changes to the structure and function of the agencies created by Congress,” said U.S. District Judge Melissa Dubose, concluding her decision.”
  • Yesterday was the effective date of the Iowa PBM reform law.  Also, yesterday, a group of employers lead by the Iowa Association of Business and Industry obtained a temporary restraining order against this law, Dropbox link to TRO order.  A preliminary injunction hearing is set for July 14. Here’s a link to an MSN article on this decision.

From the public health and medical research front,

  • Prime Therapeutic relates,
    • Only 8% of individuals (or 1 in 12) initiating a glucagon-like peptide-1 (GLP-1) agonist drug for obesity without diabetes continued to do so at three years, according to the latest real-world research from pharmacy solutions partner Prime Therapeutics LLC (Prime). Meanwhile, individuals who took a high-potency GLP-1 drug approved for obesity — such as semaglutide (Wegovy®), which is now more commonly used to treat the condition — had greater persistence at 14% three years after initiating therapy. 
    • While overall persistence continues to decrease among those taking high-potency GLP-1 products after three years, persistence among those taking the drugs over a one-year period improved throughout the span of the study. For those initiating GLP-1 therapy in 2021, 33% were persistent, while in the first quarter of 2024, 63% of new initiators were persistent. This increase is believed to be largely attributed to resolving GLP-1 drug shortages in 2024.  * * *
    • “In addition to persistence and adherence insights, the Year-3 study found 38% of individuals switched GLP-1 products during the three years of study. The mean age of individuals within the same cohort is 47 years old and nearly 80% identified as female. 
    • “For additional information and study design details, refer to Prime’s Year-3 abstract.”
  • Axios adds based on a Fair Health study that “Women approaching menopause drive GLP-1 boom.”
  • Medscape points out,
    • “A report comparing childhood obesity prevalence before the COVID pandemic and since the height of the pandemic shows a dramatic rise in the numbers for Black children and Black adolescents with obesity. Findings were published in the Annals of Internal Medicine.
    • “Researchers, led by Michael Liu, MD, MPhil, with the Center for Outcomes Research at Beth Israel Deaconess Medical Center in Boston, found that overall, the prevalence of obesity didn’t change significantly. Prevalence was 20.3% from January 2011 to March 2020, when COVID shutdowns began, and rose to 22.0% from August 2021 to August 2023. But after accounting for secular trends, “no overall increase in obesity prevalence was seen during the pandemic relative to the pre-pandemic period (adjusted difference, 0.52 percentage points; 95% CI, 2.3-3.3 percentage points).
    • “Pandemic-related increases in obesity prevalence were observed only in Black children and adolescents, the authors wrote, for whom rates were 22.4% in the decade before the pandemic and 35% in the 2 years after the height of COVID.”
  • Per Health Day,
    • “Regular exercise can ease mood disorders in children and teens, offering an alternative to medications like antidepressants, a new evidence review has concluded.
    • “Both anxiety and depression decrease when kids take part in structured exercise programs, researchers reported June 26 in Journal of the American Academy of Child & Adolescent Psychiatry.
    • “Further, the review found that anxiety and depression symptoms are relieved by different types of workout regimens.
    • “Exercise is a low-cost, widely accessible strategy that could make a real difference to children’s mental health,” lead investigator Ben Singh, a research fellow with the University of South Australia, said in a news release.
    • “Importantly, exercise could help improve kids’ moods without resorting to drugs like antidepressants, researchers added.”
  • Per Infectious Diseases Advisor,
    • “Adults aged 50 to 64 years and younger adults with chronic conditions are at increased risk for influenza-associated hospitalization and death, but this risk could be mitigated through the use of recombinant influenza vaccines (RIV). These results were published in Clinical Infectious Diseases.”
  • Healio reports,
    • “Nearly three-quarters of infants were immunized against respiratory syncytial virus through maternal vaccination or nirsevimab during the first season those products were available, according to data from 10 U.S. health systems.
    • “The overall immunization coverage for infants across these health systems was higher than expected based on the limited data available from single state studies and surveys,” Stephanie A. Irving, MHS, research associate at the Kaiser Permanente Center for Health Research in Portland, Oregon, told Healio.”
  • MedPage Today notes,
    • “In a European study, higher consumption of fruits, vegetables, legumes, and potatoes was associated with a reduced risk of Crohn’s disease.
    • “High potato consumption, meanwhile, was tied to an increased risk of ulcerative colitis.
    • “The study findings may be especially relevant for children and other first-degree relatives of people with inflammatory bowel disease, researcher says.”
  • and
    • “More than half of 95 centenarians had a low amyloid load and 9% had no amyloid, autopsy data showed.
    • “A third of centenarians had a high amyloid load comparable to Alzheimer’s disease.
    • “Five centenarians maintained high cognitive performance despite a high amyloid load.”
  • NIH Research Matters covers the following topics this week: “Home test kits for cervical cancer | Education and mortality trends | Exercise and Alzheimer’s disease.”
  • CIGNA writes in LinkedIn about why it matters to close the women’s health gap in our country.
  • MedTech Dive reports on the scientific sessions at the American Diabetes Association’s conference held last month.

From the U.S. healthcare business front,

  • STAT News reports,
    • “Centene has withdrawn its financial guidance for the rest of the year after receiving data that showed its health insurance members in Affordable Care Act plans are getting a lot more care than the company had anticipated.
    • “The company is also seeing a “step-up” in medical costs among its Medicaid enrollees. Centene’s stock plummeted 23% in after-hours trading Tuesday.”
    • “The surprise disclosure may be just the beginning of problems for Centene and other insurers that rely heavily on government health care enrollees. Centene gets a majority of its revenue from ACA and Medicaid plans. Despite Centene’s pleas to Republicans not to cut the taxpayer-funded programs, Republicans are advancing a bill that would result in the largest cut ever to Medicaid.” 
  • Healthcare Dive calls attention to “six ways employers can lower healthcare costs in 2025. ‘Employers have absorbed the majority of cost increases over the past four years, and they likely cannot continue to do so,’ one expert said” and provides an updated guide to top healthcare conferences in the second half of 2025.
  • MedCity News discusses “Innovative Strategies to Enhance Financial Predictability for Self-Funded Employers. Too often, the very systems meant to provide flexibility and control are undermined by delayed reimbursements, fragmented data, and a lack of transparency across the ecosystem. Solving this isn’t about tweaking the status quo, it requires a full redesign.”
  • Modern Healthcare tells us,
    • Ascension Health has sold four Michigan hospitals to Beacon Health System. 
    • The transaction closed Tuesday and includes four hospitals — Borgess Hospital in Kalamazoo, Borgess Allegan in Allegan, Borgess-Lee in Dowagiac and Borgess-Pipp in Plainwell — plus 35 outpatient clinics and an ambulatory surgery center, according to a Tuesday news release from Beacon. Beacon is rebranding the Ascension Southwest Michigan hospitals to Beacon Kalamazoo, Beacon Allegan, Beacon Dowagiac and Beacon Plainwell.
    • “The deal was announced in April. It brings more than 2,700 employees, including 259 providers, into the Beacon system, according to the release.
    • “South Bend, Indiana-based Beacon operates 11 hospitals, including the Ascension facilities, across northern Indiana and southwest Michigan. 
    • “Financial details of the deal were not disclosed.”
  • Per the American Journal of Managed Care,
    • “Prolonged ED stays and boarding times for older adults increased from 2017 to 2024, with academic hospitals experiencing the largest rise.
    • “The Age-Friendly Hospital Measure, effective 2025, aims to limit ED stays to under 8 hours and admissions within 3 hours.
    • “Epic Cosmos data analysis showed a significant increase in prolonged stays and boarding times, especially during the COVID-19 pandemic.
    • ‘Researchers suggest patient complexity, demand, and staffing shortages as potential drivers of increased ED stays and boarding times.”
  • Beckers Hospital Review lets us know “Physician compensation grew 4.9% in the last year, with a significant uptick for primary care physicians and specialists, according to the “AMGA 2025 Medical Group Compensation and Productivity Survey.”

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, HSA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Joshua Hoehne on Unsplash

From Washington, DC,

  • Govexec tells us,
    • Rep. Gerry Connolly, D-Va., died Wednesday morning after a battle with esophageal cancer. He was 75 years old.
    • Connolly is leaving behind a legacy as a legislator who fought for the federal workforce, government contractors and the economic development of his home region of Northern Virginia.
    • In April, Connolly announced he would not seek re-election in 2026 and would step down from his post as the ranking member of the House Oversight Committee. He first announced his diagnosis in November, shortly after easily winning a ninth term to the House.
  • RIP, Congressman.
  • The Wall Street Journal reports,
    • “House Republicans made a series of last-minute changes to their sprawling tax-and-spending bill, searching for a path that could unite the party’s warring wings headed into a nail-biter floor vote expected early Thursday.
    • “New language to assuage conservatives would accelerate new Medicaid work requirements to December 2026 from 2029 and end certain tax credits for wind energy and solar energy by 2028 instead of a slower phaseout through 2031. The updates would also formally lock in a $40,000 cap on the state and local tax deduction starting this year, up from a $30,000 cap in the prior plan; that change was designed to satisfy Republicans from high-tax states such as New York and New Jersey. 
    • “Lawmakers from states such as Florida and Texas that haven’t expanded Medicaid under Obamacare would get a favorable change to a funding formula, and border states would get $12 billion for security costs incurred during the Biden administration. An indoor-tanning excise tax that was eliminated in the original bill text would be maintained and a nuclear-energy tax break would be expanded. Federal land swaps in Nevada and Utah would be eliminated. Gun-rights supporters won changes to the tax treatment of suppressors. 
    • “The revised legislation advanced in an initial vote in the early hours of Thursday morning, with all Republicans except one in favor, and all Democrats opposed.” * * *
    • “I believe we are going to land this airplane,” Johnson said during a hectic day of legislating that saw the House Rules Committee start a hearing at 1 a.m. and continue past sunset. He is trying to finish the bill in the House before Memorial Day; it would then go to the Senate, and Republicans are aiming to get it to Trump’s desk by July 4.” 
  • Per the New York Times,
    • “The House early Thursday narrowly passed a wide-ranging bill to deliver President Trump’s domestic agenda, after Speaker Mike Johnson put down several mini-rebellions in Republican ranks to muscle the legislation to its first major victory over unified Democratic opposition.
    • “The early morning vote was 215 to 214, mostly along party lines.”
  • Fierce Healthcare adds,
    • “We have a tiny sliver that really matters to employers and working families,” said James Gelfand, president and CEO of The ERISA Industry Committee, a group representing large employers. “But I can say those provisions are monumental to us.”
    • “There’s a laundry list of items Gelfand and others are happy the bill, in its current form, includes.
    • “Employer-offered worksite clinics with free or discounted primary care services would now be available to employees on high-deductible health plans (HDHPs), even if they already have an HSA.” * * *
    • “Other changes allow HSA funds to be spent on gym memberships, increases the HSA contribution limit for some individuals, classifies bronze and catastrophic plans as a HDHP that can pair with an HSA and permits one spouse to contribute to an HSA even if the other spouse has a flexible spending account.” * * *
    • “The bill [further codifies a rule from 2019 creating the [ICHRA] program and lets employees use pretax dollars through a cafeteria plan to pay for on-exchange marketplace premiums, explains the KFF.
  • and
    • “A bipartisan bill aiming to reform prior authorization has been reintroduced in the Senate.
    • “The Improving Seniors’ Timely Access to Care Act seeks to streamline the prior auth process in Medicare Advantage (MA), which would ease administrative burdens on providers and reduce delays in accessing care for patients.
    • “The bill is co-sponsored by Sens. Roger Marshall, R-Kan., and Mark Warner, D-Va., and is supported by dozens of senators on both sides of the aisle. A version of the legislation in the House is also backed by a bipartisan group.”
  • Per an CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced a significant expansion of its auditing efforts for Medicare Advantage (MA) plans. Beginning immediately, CMS will audit all eligible MA contracts for each payment year in all newly initiated audits and invest additional resources to expedite the completion of audits for payment years 2018 through 2024.”
  • The American Hospital Association News informs us,
    • “The Administration for Strategic Preparedness and Response today released a bulletin on workplace violence in health care that includes recommendations for strengthening security protocols, enhancing emergency preparedness, supporting workforce mental health and promoting information sharing.”

From the Food and Drug Administration front,

  • BioPharma Dive points out,
    • “After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
    • “The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
    • “Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.”
  • and
    • “Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer.
    • “Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks. However, panelists wrestled with some controversial aspects of the Phase 3 trial J&J is using to ask for an expanded approval. Namely, FDA staff had flagged the trial’s inclusion of patients that could be classified as having a lower risk of progression, as well as an unclear survival benefit following disease progression.
    • “The FDA isn’t required to follow the advice of its outside expert panels but usually does.”
  • MedTech Dive adds,
    • “Teal Health published data Monday from a trial of its cervical cancer screening sample self-collection device in JAMA Network Open.
    • “The paper describes a trial of 599 people who both self-collected samples and underwent standard clinician collection. Self-collection correctly identified 95.2% of the positive samples.
    • “Teal won Food and Drug Administration approval for the self-collection device in early May, setting the company up to start shipping the product to customers in June.”
  • The New York Times provides helpful background information about the Alzheimer’s Disease blood test that the FDA approved for marketing last week.
    • “The test, manufactured by Fujirebio Diagnostics, is intended to be used only by specialists in Alzheimer’s, the F.D.A. said. Its mouthful of a name — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — describes what the test measures: levels of two proteins, amyloid and tau, that are hallmarks of Alzheimer’s disease.
    • “In people who develop Alzheimer’s, amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is much more closely correlated with cognitive decline.” * * *
    • “The F.D.A., and Alzheimer’s experts, emphasized that the blood test should be given only to people who are already experiencing cognitive decline and are ages 55 and older. Moreover, it should not be used on its own to diagnose or to rule out Alzheimer’s.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Biden’s cancer diagnosis has sparked a debate over prostate-cancer screening guidelines.
    • “Increased diagnoses of later-stage cancers are suspected to be linked to changing screening guidance.
    • “Some prostate-cancer specialists said that there has also been a shift in how they manage lower-risk prostate cancer.”
  • Per STAT News,
    • “In what researchers hope could be a case of 1 + 1 = 3, new research suggests that combining a model to predict 10-year cardiovascular risk with an imaging test of coronary arteries could be better than either method alone at identifying people in danger of their first heart attack.
    • “The model is PREVENT, which computes a risk score based on measures familiar from the primary care office: blood pressure, cholesterol levels, kidney function, age, and BMI, as well as questions about type 2 diabetes, smoking, and social determinants of health. The imaging test is a CT scan that detects calcium buildup in arteries leading to the heart. High amounts of calcium, alone and inside fatty plaques, can lead to blockages and heart attacks.” * * *
    • “It’s not always clear who should be screened for coronary calcium; thus, we decided to see if the PREVENT score could be used in this novel manner,” Morgan Grams of New York University’s Grossman School of Medicine told STAT. She is an author of the study published Wednesday in the Journal of the American Heart Association. “Once we determined that it could, we assessed whether the coronary calcium score could add information to PREVENT in the prediction of incident cardiovascular disease. It did.”
       
  • Per a National Institute of Health news release,
    • Research teams funded by the National Institutes of Health (NIH) have created a versatile set of gene delivery systems that can reach different neural cell types in the human brain and spinal cord with exceptional accuracy. These delivery systems are a significant step toward future precise gene therapy to the brain that could safely control errant brain activity with high precision. In contrast, current therapies for brain disorders mostly treat only symptoms.
    • The new delivery systems carry genetic material into the brain and spinal cord for targeted use by specific cell types. This platform has the potential to transform how scientists can study neural circuits. It provides researchers with gene delivery systems for various species used in research, without the need for genetically modified, or transgenic, animals. Examples include illuminating fine structures of brain cells with fluorescent proteins and activating or silencing circuits that control behavior and cognition.
    • “Imagine this new platform as a delivery truck dropping off specialized genetic packages in specific cell neighborhoods in the brain and spinal cord,” said John Ngai, Director of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “With these delivery systems, we can now access and manipulate specific cells in the brain and spinal cord – access that was not possible before at this scale.”
  • Healio notes,
    • “Increased dietary fiber was associated with reduced likelihood of stroke, especially small-vessel stroke, in addition to reduced all-cause mortality and improved poststroke survival, researchers reported.
    • “Data on the link between daily dietary fiber intake and odds of stroke and adverse stroke outcomes were published in Stroke.”

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “Sanofi will acquire Vigil Neuroscience for $470M, potentially reaching $600M with milestone payments.
    • “The deal centers on neurology, adding VG-3927, an Alzheimer’s treatment, to Sanofi’s pipeline.
    • “Vigil’s VGL101 molecule will return to Amgen before the Sanofi acquisition closes in Q3.”
  • Fierce Healthcare reports,
    • “Digital physical therapy company Hinge Health priced its IPO at $32 per share on Wednesday, at the top of the company’s expected price range.
    • “The company said it raised $437 million by selling 13,666,000 million shares of its Class A common stock, according to a press release issued Wednesday. Hinge Health said it sold 8.5 million shares and 5.1 million shares are being sold by existing shareholders.
    • “Hinge Health will begin trading tomorrow morning on the New York Stock Exchange under the ticker symbol “HNGE.” The offering is expected to close May 23.”
  • Fierce Pharma relates,
    • “Cigna’s Evernorth is rolling out a new pharmacy benefit management program that caps members’ monthly cost for key GLP-1 drugs.
    • “Evernorth said in an announcement that through its Express Scripts arm it negotiated directly with the manufacturers for Wegovy and Zepbound—Novo Nordisk and Eli Lilly, respectively—to cap patients’ monthly costs at $200. The company said this could save as much as $3,600 per year compared to savings patients receive through direct-to-consumer discount programs.
    • “Evernorth added that the costs will contribute toward a patient’s deductible as well.
  • CNBC adds, “Evernorth’s new weight loss pricing program will begin in the second half of the year, as employers begin to make decisions about coverage for next year’s plans.”
  • Per STAT News,
    • “Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans saved considerable money on a generic cancer medicine thanks to its “transparent” pricing model. And it maintains that the findings validate plans to distribute and — eventually — manufacture still more copycat medicines for the U.S. market.
    • “The company — CivicaScript — was created as a vehicle to combat stubbornly high drug prices even after dominant brand-name medicines lost patent protection and generic competitors entered the market. Backed mostly by 18 Blue Cross Blue Shield plans, the nonprofit made its first drug available — a generic version of the Zytiga prostate cancer treatment — in August 2022.
    • “The initial wholesale price was $160, plus an $11 dispensing fee paid to pharmacies, but uptake was slow until it was accepted by pharmacy benefit managers and other health plans. But eventually, the gambit worked: Between September 2023 and December 2023, patients saved 64% and payers saved 92% by purchasing the generic distributed by CivicaScript, according to a new analysis.”
  • Beckers Payer Issues offers the view of eleven payer “leaders to learn what’s overhyped in healthcare.” 

Thursday Report

David Ermer–ACA, AHRQ, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Senate has adjourned until next Monday with no sign of when the President’s nominee for OPM Director Scott Kupor will receive floor consideration. According to the Senate Executive Calendar, there are many nominees besides Mr. Kupor patiently waiting their turn.
  • Federal News Network offers an article about Wednesday’s House Oversight Committee markup and passage of its budget resolution.
  • Per a Senate press release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announcement of Generation Gold Standard, a new initiative to pursue a universal vaccine platform for viruses that are most likely to cause pandemics. HHS Secretary Kennedy and NIH Director Bhattacharya announced the initiative to protect people against multiple strains of widely contagious viruses through a beta-propiolactone (BPL)-inactivated, whole-virus platform.  
    • “Scientists have long considered universal vaccines as the Holy Grail solution to protect Americans from quickly mutating viruses,” said Dr. Cassidy. “I am glad that Secretary Kennedy and the Trump administration are prioritizing this important area of research so we can be better prepared to tackle tomorrow’s health threats.”
    • “According to HHS, the clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the Office of the Assistant Secretary for Health and Office of Population Affairs, released a comprehensive review, opens in a new tab of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria. This review, informed by an evidence-based medicine approach, reveals serious concerns about medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.
    • “The review highlights a growing body of evidence pointing to significant risks—including irreversible harms such as infertility—while finding very weak evidence of benefit. That weakness has been a consistent finding of systematic reviews of evidence around the world.
    • “The review also fills a gap in the medical literature and existing clinical practice reviews with regard to the ethical aspects of pediatric medical transition. HHS believes that medical ethics should be central in this debate.”
  • The Internal Revenue Service announced
    • SECTION 2. 2026 INFLATION ADJUSTED ITEMS
      • “.01 Health Savings Account Inflation Adjusted Items.
        • “(1) Annual contribution limitation. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(A) for an individual with self-only coverage under a high– deductible health plan is $4,400. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(B) for an individual with family coverage under a high deductible health plan is $8,750.
        • “(2) High deductible health plan. For calendar year 2026, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,700 for self-only coverage or $3,400 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,500 for self-only coverage or $17,000 for family coverage.”
  • OPM proposed a new rule
    • “The Office of Personnel Management (OPM) is proposing to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Currently, agencies are prohibited from establishing quotas or limits on the number or proportion of the various rating levels assigned, meaning that each senior executive potentially can receive any rating based on their performance, irrespective of how other senior executives perform within the agency. However, governmentwide SES ratings data have consistently shown that virtually all SES receive the highest rating levels (i.e., levels 4 and 5) despite documented reports of SES failings. Removing the prohibition on forced distribution would allow agencies to establish and enforce limits on the highest SES rating levels, thereby increasing rigor in the SES appraisal process and leading to a more normalized distribution of SES ratings across the Federal Government.”
    • The FEHBlog estimates that the public comment period will end on June 2, 2025.
  • Tammy Flanagan, writing in Govexec, provides “a crash course in retirement planning. Let’s revisit my tips and resources for transitioning from employee to annuitant.”
  • Fierce Healthcare lets us know,
    • The Centers for Medicare & Medicaid Services (CMS) has launched the Fraud Detection Operation Center (FDOC) to fight waste, fraud and abuse, the agency announced this week.
    • Listed on a new webpage are a list of “recent success stories.” They include taking action against improper enrollment in Affordable Care Act (ACA) plans, cracking down on false billing of wound care services and scrutinizing “problematic activities” regarding hospice claims.
    • The page also claims it stopped payments to a provider who died 20 years ago as well removed 18 providers convicted of a “serious crime” for not meeting adequate standards.” ***
    • “The FDOC leverages the Fraud Prevention System (FPS), a system developed, built and operated by federal contractor Peraton. The FPS uses artificial intelligence and machine learning models to flag potentially fraudulent behavior by providers, allowing investigators to more easily see whether a provider should be funneled to the government’s case management system.”

From the Food and Drug Administration front,

  • Fierce Pharma tells us,
    • “Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in “radical” changes to how it signs off on new vaccines.
    • “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. 
    • “It isn’t immediately clear which “new” vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.” * * *
  • Per BioPharma Dive,
    • “The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
    • “Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Department of Justice is accusing three of the largest health insurers in the U.S. of paying brokers kickbacks for enrolling seniors in their Medicare Advantage plans.
    • “CVS unit Aetna, Elevance and Humana paid brokers eHealth, GoHealth and SelectQuote hundreds of millions of dollars in return for signing people up for their MA coverage from 2016 to 2021 — regardless of the plans’ suitability for those members’ needs, according to the DOJ’s complaint filed Thursday.
    • “Spokespeople for Humana and CVS said the companies are reviewing the DOJ’s complaint and did not provide detailed comment for this story, though CVS said it disagrees with the allegations. Elevance did not respond to a request for comment.”

From the public health and medical research front,

  • CBS News reports,
    • “Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.
    • “There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC’s National Center for Health Statistics. 
    • “Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. 
    • “Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death,” Christopher Holliday, head of the CDC’s Division of Diabetes Translation, told CBS News in a statement.
    • “Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.”
  • MedPage Today adds,
    • While the incidence of breast cancer in young women has been increasing over the last 20 years, breast cancer deaths in this age group fell significantly between 2010 and 2020, researchers found.
    • Among women ages 20 to 49, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47 per 100,000 in 2020, reported Adetunji Toriola, MD, PhD, MPH, of the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, at the American Association for Cancer Research annual meeting in Chicago.” * * *
    • “While breast cancer mortality declined for each racial/ethnic group, rates differed substantially between groups.
    • “Black women had the highest incidence-based mortality in 2010 (16.56 per 100,000), and while that rate declined significantly over the next decade, these women still had the highest incidence-based mortality rate in 2020 (3.41 per 100,000).
    • “White women had the lowest incidence-based mortality in 2010 (9.18 per 100,000) and 2020 (1.16 per 100,000).
    • “Moreover, 5-year relative survival rates by race/ethnic group showed that rates exceeded 88.7% for most groups, except for Black women (82.4%). That discrepancy was similar for 10-year relative survival rates.
    • “There were significant declines in mortality among women aged 20 to 49 with breast cancer,” Toriola said during a press briefing. “However, there are still opportunities for improvements, especially in relation to eliminating disparities in survival.”
  • HCPLive informs us,
    • The burden of chronic kidney disease (CKD) attributable to physical inactivity increased significantly from 1990-2021, according to findings from a recent study
    • Leveraging data from the Global Burden of Disease (GBD) 2021, the study found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years (DALYs) have risen significantly, especially in low-sociodemographic index (SDI) regions, among older adults, and in females.1
    • “In recent years, low physical activity has become a major risk factor for noncommunicable diseases, contributing to the increased incidence of various chronic conditions, including diabetes, cardiovascular diseases, and CKD,” ZhenYi Zhao, of the School of Competitive Sports at Beijing Sport University in China, and colleagues wrote.
  • Per an NIH news release,
    • “The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy.”
  • The New York Times reports,
    • The happiness curve is collapsing.
    • For decades, research showed that the way people experienced happiness across their lifetimes looked like a U-shaped curve. Happiness tended to be high when they were young, then dipped in midlife, only to rise again as they grew old.
    • But recent surveys suggest that young adults aren’t as happy as they used to be, and that U-shaped curve is starting to flatten.
    • This pattern has shown up yet again in a new study, one of a collection of papers published on Wednesday in the journal Nature Mental Health. They are the first publications based on the inaugural wave of data from the Global Flourishing Study, a collaboration between researchers at Harvard and Baylor University.” * * *
    • “The study participants had relatively low measures of flourishing on average until age 50, the study found. This was the case in a number of countries, including the United Kingdom, Brazil and Australia. But the difference between the younger and older adults was largest in the United States, the researchers said.
    • “It is a pretty stark picture,” said Tyler J. VanderWeele, the lead author of the study and director of Harvard’s Human Flourishing Program. The findings raise an important question, he said: “Are we sufficiently investing in the well-being of youth?”
  • Healio relates,
    • “Individuals using e-cigarettes exclusively had a significantly elevated risk for COPD, whereas this was not found when assessing the risk for type 2 diabetes or heart failure, according to data published in Nicotine and Tobacco Research.
    • “For clinicians, these results offer helpful information about how e-cigarettes compare to regular cigarettes in terms of health risks,” John Erhabor, MD, MPH,research postdoctoral fellow at Johns Hopkins Medicine, told Healio. “While e-cigarettes may have fewer heart and metabolic risks than regular cigarettes, they are still tied to certain problems like COPD and possibly high blood pressure in some age groups.
    • “Doctors should take these differences into account when advising patients and make clear that switching completely from regular cigarettes to e-cigarettes may potentially lower health risks, but using both does not offer the same benefit,” Erhabor said.”
  • The American Medical Association News points out,
    • “The Health Resources and Services Administration announced its toll-free number (1-833-TLC-MAMA) and promotional toolkit are available in advance of Maternal Mental Health Awareness Week, May 5-11. Since its launch on Mother’s Day 2022, the hotline has received more than 54,173 calls and texts from individuals seeking help for themselves (73%) or on behalf of someone else (4%). The hotline is available in English and Spanish and offers interpreters in more than 60 languages.”
  • The U.S. Preventive Services Task Force released a final research plan for “Sexually Transmitted Infections: Behavioral Counseling.” The next step is a proposed recommendation.
  • STAT New warns,
    • The era of “tranq” may be ending.
    • “But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
    • “In Philadelphia in particular, reports of medetomidine have skyrocketed. When the city first began testing for the substance in May 2024, it found medetomidine in 29% of fentanyl samples analyzed, according to data from the city’s public health department. Six months later, medetomidine’s prevalence had increased threefold to 87% — while xylazine’s dropped from 100% early in the year to 42% in November.”
  • The CDC adds in a related report issued today,
    • Summary
    • What is already known about this topic?
      • Medetomidine is an increasingly common adulterant of illegally manufactured opioids.
    • What is added by this report?
      • During October 2024–March 2025, a total of 23 adult patients who used illegally manufactured opioids sought treatment within a health care system in Pittsburgh, Pennsylvania. All exhibited severe autonomic hyperactivity, and most required dexmedetomidine infusion and intensive care unit–level management. Medetomidine metabolites were detected in all 10 patients for whom retrospective analysis was performed, despite only two having detectable parent compound (medetomidine) on comprehensive urine drug screening.
    • What are the implications for public health practice?
      • Health care providers in regions where medetomidine has been detected in the drug supply should be prepared to manage a severe withdrawal syndrome among patients who use illegally manufactured opioids, even if drug testing for medetomidine is negative.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health’s insurance division Aetna will stop offering plans for individuals on the Affordable Care Act exchanges in 2026, after the company projected big losses in the business this year.
    • “The news was announced in tandem with CVS’ first quarter results, which exceeded investor expectations and represent a turnaround for CVS’ beleaguered insurance business, analysts said. The Rhode Island-based healthcare company reported net profit of $1.8 billion — up 60% year over year — on revenue of $94.6 billion.
    • “CVS’ pharmacy benefit manager Caremark also reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase access to Wegovy at the expense of other therapies, such as Eli Lilly’s Zepbound.”
  • Fierce Pharma notes,
    • “Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.
    • “Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.
    • “On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.
    • “Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation.”
  • The Leapfrog Group released its Spring 2025 hospital patient safety grades today.
  • Per MedTech Dive,
    • “GE Healthcare cut its 2025 adjusted earnings outlook to reflect an estimated 85-cent-per-share impact from tariffs, especially duties affecting trade with China, executives said on an earnings call Wednesday.
    • “CEO Peter Arduini said bilateral U.S. and China tariffs account for 75% of the total net impact.
    • “For the full year, GE Healthcare now expects adjusted earnings in a range of $3.90 to $4.10 per share, down from the prior estimate of $4.61 to $4.75.
    • “The revised outlook assumes that tariffs remain at the current elevated levels and that U.S. reciprocal tariffs on the rest of the world — announced April 2 — return to pre-pause rates on July 9. The forecast also assumes Mexico and Canada tariffs remain in place, with exemptions under the U.S.-Mexico-Canada Agreement continuing for all eligible imports.”
  • and
    • “Abbott has struck a deal to integrate data from its Libre continuous glucose monitors into Epic’s electronic health record systems in the U.S., the companies said Tuesday.
    • “The integration will connect Abbott’s data management software to Epic’s EHR systems. Linking the systems will allow clinicians to view glucose data captured by Libre devices within Epic. 
    • “The Epic integration could be the start of a broader Abbott initiative. Lisa Earnhardt, group president of medical devices for Abbott, said in a statement that the company aims to expand the integrated model to “other medical devices and connected care platforms in the future.”
  • Modern Healthcare reports,
    • “Medical weighing and measuring technology company seca launched the first compact, portable body composition scanner designed for primary care on Thursday.
    • “The mBCA Alpha scanner generates a detailed assessment of a patient’s body composition in 24 seconds, which includes percentages of fat, bone and muscle. Clinicians can use the information to spot early signs of excess body fat, age-related muscle decline and the impact medications like GLP-1s can have on the body, among other factors.
    • “Primary care physicians typically rely on weight and body mass indexing to determine a patient’s risk of chronic conditions such as obesity, diabetes, heart disease and metabolic syndrome. But body mass index doesn’t reflect muscle mass or fat distribution, which can vary significantly depending on age, gender and race, according to Nina Crowley, director of clinical education and partnerships at seca.
    • “The American Medical Association issued a policy update in June 2023 that called out body mass index as an imperfect way of measuring body fat in some populations and recommended it be used in conjunction with other screenings including body composition.
    • “Other imaging modalities like MRI and dual-energy X-ray absorptiometry can also provide information about a patient’s body composition, but Alpha can do it at a fraction of the cost, according to Crowley.”

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, NIH, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“
  • The Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Weekend Update

David Ermer–CDC, CMS, Congress, HSA, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • On Saturday, the House Appropriations Committee unveiled “The Full-Year Continuing Appropriations and Extensions Act, 2025.”
  • The Wall Street Journal adds,
    • “House lawmakers are expected to vote on the proposal, termed a continuing resolution or CR, as soon as Tuesday, with a majority needed to pass it. But even if House Republicans manage to stay united and pass the proposal over Democratic opposition, it will need at least 60 votes in the Senate, which has only 53 Republican lawmakers. 
    • “Funding for federal agencies runs out on Friday night. With no new legislation, many federal employees would be furloughed, while others would continue to report to work with no pay.” 
  • The Senate will be voting to confirm the President’s nominee for Secretary of Labor Lori Chavez-DeRemer Monday afternoon.
  • Committee meetings of note:
    • Committee: House Oversight and Government Reform
      Subcommittee: House Oversight and Government Reform Subcommittee on Government Operations
      Subject: “Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud”
      Date: 03/11/2025 (10:00 AM Local Time)(Add to My Calendar)
      Location: 2247 Rayburn House Office Building, Washington, D.C.
    • Committee: Senate Health, Education, Labor, and Pensions. Subject: Business meeting to consider the nominations of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, and Martin Makary, of Virginia, to be Commissioner of Food and Drugs, both of the Department of Health and Human Services, and other pending calendar business
      Related Items: PN12-2, PN12-28
      Date: 03/13/2025 (9:30 AM Local Time)   (Add to My Calendar)
      Location: 562 Dirksen Senate Office Building, Washington, D.C.
    • Committee Senate Finance Committee Subject: Hearing to consider the nomination of Dr. Mehmet Oz to be CMS Administrator
      Witness: Dr. Mehmet Oz 
      Date: Friday, March 14, 2025, 10:00 AM Local Time)
      Location: 215 Dirksen Senate Office Building, Washington, DC
  • The AP explains “How a health savings account fits into your retirement strategy.”

From the public health front,

  • The Wall Street Journal explores how “One Couple in Their 90s Confronts a Stark Reality: Aging at Different Speeds; Lifelong partners grapple with how and whether to stay together when one can’t care for the other.”
  • The New York Times points out six sources of protein that are not meat and answers questions about fentanyl.
  • Beckers Hospital Review notes,
    • Researchers from the University of Texas Health Science Center at San Antonio have developed a drug that more than doubled median survival time and progression-free time for patients with glioblastoma during a clinical trial.
    • Patients who received the drug Rhenium Obisbemeda, or 186RNL, also experienced no dose-limiting toxic effects, according to a March 7 news release from UT Health San Antonio.
    • Glioblastoma is the most common form of brain tumor, with more than 90% of patients experiencing recurrence. If standard treatment fails, the median survival time is about eight months, the release said. \
    • “Glioblastoma has needed durable treatments that can directly target the tumor while sparing healthy tissue,” Andrew Brenner, MD, PhD, professor and chair of neuro-oncology research with Mays Cancer Center at UT Health San Antonio, said in the release. “This trial provides hope, with a second phase under way and planned for completion by the end of this year.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Higher volumes, more favorable reimbursement rates and more efficient labor spending helped Providence cut its 2024 operating losses nearly in half.
    • “On Thursday the nonprofit system reported a $644 million operating loss (-2.1% operating loss) across 2024, a stark improvement over the $1.17 billion operating loss (-4.1% operating margin) of the year prior. The 2024 tally includes $183 million in reconstruction costs “related to asset rationalization, employee reductions and other items,” according to its filing.
    • “Operating revenues across the system grew 7% year over year to $30.7 billion (5% when excluding a $426 million net gain in the first quarter), with management noting in its filing that the growth was spread across all of its operating categories.”
  • and
    • “Earlier this week, Eli Lilly partnered up with telehealth providers LifeMD and Teladoc Health to offer its lower cost, single-vial Zepbound (tirzepatide) to patients in the virtual care companies’ full-service weight loss management programs.
    • “The companies are directly contracting with Eli Lilly’s self-pay pharmacy, GiftHealth. The move could be a boon for telehealth weight loss programs, which have proved lucrative for virtual primary care companies. Many of the chronic condition management programs, including for weight loss, also offer remote monitoring, access to dietitians and health coaches, as well as the ability to be prescribed medication for weight loss, including older medications.
    • “The announcement follows Eli Lilly’s partnership with telehealth platform Ro three months ago. The pharmaceutical company launched its own direct-to-consumer telehealth offering for weight loss in January 2024. Now, it seems to be creating a marketplace of access.”
  • Beckers Payer Issues ranks Medicare insurers by the quality of their mobile applications.

Thursday Report

David Ermer–AHRQ, CDC, Congress, Electronic health records, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Fierce Healthcare reports,
    • “New legislation advanced by a voice vote March 4 would codify 14 pre-deductible healthcare services through high-deductible health plans (HDHPs).
    • “It codifies guidance from President Donald Trump’s first term increasing flexible coverage options for HDHPs. The bill would allow medical products and services like beta-blockers, blood pressure monitors, glucometers, inhalers and cholesterol drugs to be more easily covered by insurance by letting insurers pay for low-cost services before a deductible is reached.
    • “This legislation provides employers and their employees with greater flexibility to design healthcare coverage options that expand access to treatments for chronic diseases,” said Ways and Means Committee Chairman Jason Smith, R-Missouri, in a statement on the House floor. “By providing flexible coverage options for more people living with chronic health conditions, we can help lower their costs and improve their health and well-being.” * * *
    • “The bill must still be passed by the full Senate.”
  • Roll Call tells us,
    • “Senate Republicans called on the Trump administration Wednesday to use the formal rescissions process to claw back money already appropriated by Congress that the “Department of Government Efficiency” has identified as wasteful.
    • “It’s also a way to avoid legal setbacks that have befallen the White House in its push to freeze agency budgets and programs, including foreign aid accounts.
    • “One day after President Donald Trump singled out small-dollar examples of waste in his joint address to Congress, the de facto leader of the DOGE effort, Elon Musk, came to the Capitol to soothe concerns over how some of the cuts have been implemented. Many lawmakers have expressed alarm at the wholesale gutting of agencies and the firing of thousands of federal employees.
    • “Hoping to regain some of their power of the purse, senators asked Musk at a private lunch to have the White House submit a rescissions package for congressional approval for any funding it deems fraudulent or wasteful. Congress would then have 45 days to approve the request, or else the money must be spent as appropriated once the clock runs out.
    • “What we got to do as Republicans is capture their work product, put it in a bill and vote on it,” Senate Budget Chairman Lindsey Graham, R-S.C., told reporters. “So the White House, I’m urging them to come up with a rescission package.”
    • “Graham said Musk was receptive to the idea and hadn’t known about the rescissions process as an available tool to cut spending.”
  • BioPharma Dive lets us know,
    • “Marty Makary, the Johns Hopkins surgeon who President Donald Trump chose to lead the Food and Drug Administration, fended off pressure from Republican and Democratic senators Thursday over a canceled agency meeting on influenza vaccines. 
    • “Questioned by several lawmakers at a hearing held to evaluate his nomination, Makary would not commit to reconvening the meeting, at which agency advisers were set to discuss the composition of this year’s flu shots. Members of the panel were notified last week that they would not meet as scheduled. 
    • “Instead, Makary seemed to indicate he would take a broader look at the role the advisory committee plays in the FDA’s vaccine decision-making and whether it is providing useful advice. 
    • “You have my commitment to review what the committees are doing [and] how they are being used,” Makary told Senator Bill Cassidy, R-La., who serves as chair of the Senate Health, Education, Labor, and Pensions Committee reviewing Markary’s nomination.” 
  • Per an HHS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) alerted providers of their obligation to protect American children from often irreversible chemical and surgical mutilation, including interventions that cause sterilization. Hospital providers were alerted of serious quality and safety concerns associated with harmful, medical interventions for gender dysphoria. CMS also announced it may begin taking steps to align its policies and regulations with medical evidence and to safeguard children from often irreversible experiments. CMS will continue to follow any applicable substantive and procedural requirements in taking any future action.” * * *
    • “Similar alerts are also being sent by other HHS agencies to grantees. View the CMS alert here: https://www.cms.gov/files/document/QSSAM-25-02-Hospitals.pdf”  
  • Govexec informs us,
    • “Special Counsel Hampton Dellinger said in a statement to Government Executive that he is dropping his lawsuit to reverse his removal by Donald Trump, enabling the president to name his own person to lead the office that protects federal employees and whistleblowers from prohibited personnel practices.
    • “A district judge on March 1 blocked Dellinger’s firing, but the U.S. Court of Appeals for the D.C. Circuit on Wednesday allowed for him to be removed while it considers the Trump administration’s appeal.”
  • Federal News Network interviewed Tammy Flanagan about RIFs and early retirement for federal employees.

From the judicial front,

  • Thompson Reuters relates,
    • A federal trial court [in Maine} has dismissed a proposed class action lawsuit against an insurer/health plan administrator alleging discrimination under Affordable Care Act (ACA) Section 1557 for failure to cover weight-loss drugs. The participant alleged that the insurer’s plan violated Section 1557 (which prohibits discrimination in certain health programs and activities based on race, color, national origin, sex, age, or disability) because it excluded prescription drug coverage for commonly prescribed weight-loss medications if they were prescribed solely to treat obesity. She argued that she did not have access to the prescription medications required to treat her obesity (which she alleged was a disability and diagnosed health condition), while other participants had access to prescription medications medically necessary to treat their diagnosed health conditions, including the same or similar medications.
    • Concluding that the participant’s allegations did not support a finding of disability under Section 1557, the court dismissed the case. It determined that the participant had not plausibly shown that she was disabled merely as a function of her body mass index, nor that the insurer had ever regarded her as disabled. Pointing out that disability is an essential element of a Section 1557 disability discrimination claim, the court held that the participant had failed to state a claim for relief.
  • Fierce Health notes,
    • “Dozens of providers have filed new lawsuits against Blues insurers, arguing that the plans colluded to block competition and reimburse them at lower rates.
    • “The payers reached a tentative $2.8 billion settlement agreement in Alabama court in October, but the new lawsuits opt out of it and instead press for a jury trial. The Blue Cross Blue Shield Association and 33 of its affiliates are named in the new suits.
    • “Providers who have signed on to the filings include the University of Pennsylvania Health System, Geisinger, MedStar, CommonSpirit and physician staffing firm TeamHealth. They argue that the alleged collusion between Blues plans violated antitrust laws.”

From the Food and Drug Administration,

  • Cardiovascular Business reports,
    • “Genentech, part of the Roche Group, has received U.S. Food and Drug Administration (FDA) approval for tenecteplase, the company’s new intravenous treatment for acute ischemic stroke (AIS) in adult patients. Genentech will be marketing and selling tenecteplase under the brand name TNKase. 
    • “Tenecteplase is only the second clot-busting medication for stroke to gain approval from the FDA—and the first in decades. The only other one, alteplase, is also sold by Genentech under the brand name Activase.
    • ‘Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. This is much faster than alteplase, which was administered by giving patients an IV bolus that is then followed by a 60-minute infusion.”
  • The American Hospital Association (AHA) News adds,
    • “The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious adverse health consequences. Baxter has reported one serious injury related to the issue.”
  • Per MedTech Dive,
    • “Philips stopped selling an implant used to repair damaged arteries after reports of 20 injuries and some devices needing to be removed.
    • “The Food and Drug Administration said in a Monday recall notice that all customers should stop using Philips’ Tack Endovascular System immediately. The agency classified the recall as Class I, the highest risk category.
    • “Philips is not aware of serious harm or death accompanying the use of the device, a company spokesperson wrote in an email. The FDA said no deaths were reported.”

From the public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention March 4 announced it sent agency experts to Texas to assist local officials in responding to the state’s measles outbreak. The CDC said the partnership, known as an Epi-Aid, is a rapid response effort by the agency’s Epidemic Intelligence Service to respond to urgent public health issues such as disease outbreaks. EIS officers will provide onsite support for one to three weeks. 
    • “As of March 4, there were 159 measles cases identified, according to the Texas Department of State Health Services. Twenty-two patients have been hospitalized and a school-aged child died Feb. 26. Texas DSHS officials said additional cases are likely to occur.” 
  • The New York Times reports
    • “Women’s brains are superior to men’s in at least in one respect — they age more slowly. And now, a group of researchers reports that they have found a gene in mice that rejuvenates female brains.
    • “Humans have the same gene. The discovery suggests a possible way to help both women and men avoid cognitive declines in advanced age.
    • “The study was published Wednesday in the journal Science Advances. The journal also published two other studies on women’s brains, one on the effect of hormone therapy on the brain and another on how age at the onset of menopause shapes the risk of getting Alzheimer’s disease.”
  • and
    • “Postpartum depression affects about one in every seven women who give birth, but little is known about what happens in the brains of pregnant women who experience it. A new study begins to shed some light.
    • “Researchers scanned the brains of dozens of women in the weeks before and after childbirth and found that two brain areas involved in the processing and control of emotions increased in size in women who developed symptoms of postpartum depression.
    • “The results, published Wednesday in the journal Science Advances, constitute some of the first evidence that postpartum depression is associated with changes in the brain during pregnancy.”
  • The Washington Post adds,
    • “Bacterial vaginosis, a common vaginal infection also known as BV, has long been treated as a women’s condition; but a new study adds to evidence that it is a sexually transmitted infection and suggests that treating a male partner can help reduce recurrence.
    • “BV affects nearly 1 in 3 women of reproductive age globally. It has been associated with increased risk of adverse birth outcomes, HIV and other sexually transmitted infections, according to the World Health Organization. It has a high recurrence rate, with more than half of those who are treated experiencing the condition again within three months.
    • “The study, led by a team of Australian researchers, was published in the New England Journal of Medicine on Wednesday.”
  • The U.S. Preventive Services Task Force released for public comment a Draft Research Plan regarding Cognitive Impairment in Older Adults: Screening. The public comment deadline is April 2, 2025.
  • Per MedPage Today,
    • “In a retrospective study, semaglutide use leading up to bariatric surgery was not linked with greater weight loss a year after surgery.
    • “Rates of diabetes remission and complications were also comparable between semaglutide users and controls.
    • “Previous studies have found that taking semaglutide after surgery can help patients shed more pounds.”
  • Per Healio,
    • “Using visualized coronary calcium scoring independently reduced plaque progression among patients at intermediate risk vs. usual care.
    • “Improvements in lipid profiles were also reported.”
  • Per Medscape,
    • “Reports of children in the United States with influenza-associated encephalopathy or encephalitis (IAE) increased from none during the 2020-2021 flu season to a preliminary 14% for the 2024-2025 season, based on a new analysis from the Centers for Disease Control and Prevention (CDC).
    • “IAE involves a range of neurologic syndromes triggered by flu infection of the respiratory tract, with diagnosis based on brain lesions detectable on imaging, wrote Amara Fazal, MD, and colleagues at the CDC’s National Center for Immunization and Respiratory Diseases.
    • “A series of anecdotal reports of pediatric cases with IAE in January 2025 prompted the CDC’s investigation; the findings were published in the Morbidity and Mortality Weekly Report (MMWR).”

From the U.S. healthcare business front,

  • Beckers Hospital Review offers five takeaways from this week’s HIMSS conference and lets us know the amount of cash on hand for 35 U.S. healthcare systems as of December 31, 2024.
  • Beckers Payer Issues lets us know,
    • Blue Cross and Blue Shield of North Carolina has restructured to become a subsidiary of a new parent holding company, CuraCor Solutions.
    • CuraCor will include Blue Cross NC and other fully owned companies, allowing the new organization “to quickly partner and invest in new health programs and technologies to benefit customers,” according to a March 6 news release shared with Becker’s.
    • Blue Cross NC members will experience no changes to coverage, services or the open enrollment process. Insurance cards, provider networks and Medicaid and Medicare offerings will also remain the same.
  • Per Fierce Healthcare,
    • “Datavant is beefing up its data retrieval network with a new layer of artificial intelligence that will allow health plans and risk-bearing providers to improve operations and patient care by accessing and analyzing a trove of clinical data.
    • “Value-based care arrangements require health plans and risk-bearing providers to navigate complicated requirements for managing patient data and monitoring population health. While providers and health plans face increasing cost pressure and administrative burden, Datavant touts that the enhanced platform will ease the administrative burden of locating and analyzing patient and member data.
    • “Datavant’s new Clinical Insights Platform is the result of Datavant’s integration with Apixio. It acquired the company’s connected care platform and value-based care solutions in September 2024. With the release of the Clinical Insights Platform, the Apixio brand will sunset and the combined Datavant-Apixio product will be sold.”

FEHBlog Extra

David Ermer–ACA, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, OPM, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “President-elect Donald Trump has announced plans to nominate a new leader for the Office of Personnel Management.
    • “On Sunday evening, Trump’s team shared in a press email that Scott Kupor, currently a managing partner at venture capital firm Andreessen Horowitz, is the planned pick for OPM director in Trump’s second term.
    • “Scott will bring much needed reform to our federal workforce,” Trump said in a statement on Sunday.
    • “Prior to his current role at Andreessen Horowitz, Kupor served as chairman of the National Venture Capital Association from 2014 to 2018, according to his LinkedIn profile. Kupor has also worked as vice president and general manager of technology company Hewlett-Packard (HP) and held various other executive management roles in the private sector. * * *
    • “Kupor graduated Phi Beta Kappa from Stanford University with a bachelor’s degree in public policy with honors and distinction. He also holds a law degree with distinction from Stanford University and is a member of the State Bar of California.”
  • and
    • “President Joe Biden has finalized a 2% federal pay raise for the General Schedule, but the increases federal employees across the country will see when they open their first paycheck of 2025 will look a little different.
    • “That’s because the 2% federal pay raise is an average — it will vary slightly depending on where federal employees work and their locality pay area.
    • “Biden’s 2% raise includes a 1.7% across-the-board boost that most civilian employees on the General Schedule will get, as well as an average of a 0.3% locality pay adjustment. The 0.3% portion of the raise accounts for the variations in next year’s federal pay raise. Starting in January, some feds’ raises will be slightly above the 2% average raise, while others will see slightly less than the average.
    • “For 2025, the spread of raises ranges from a high of 2.35% in the San Francisco-San Jose-Oakland locality pay area, and a low of 1.88% in the Cleveland locality pay area, according to the General Schedule pay tables the Office of Personnel Management published Monday afternoon. Federal employees working in the national capital region will get a 2.22% raise next year.”
  • Bloomberg reports,
    • “The Biden administration on Monday withdrew a proposed rule that, if finalized, would have expanded access to birth control coverage offered under the Affordable Care Act.
    • “The ACA guarantees coverage of women’s preventive services, like birth control and contraceptive counseling, at no cost for women enrolled in group health plans or individual health insurance coverage. In 2018, new regulations expanded exemptions for religious beliefs and moral convictions that allow private health plans and insurers to deny coverage of contraceptive services.
    • “The [February 2, 2023] proposal—from the departments of Health and Human Services (RIN: 0938-AU94), Labor (RIN: 1210-AC13), and Treasury (RIN: 1545-BQ35)—would have removed the moral exemption waiver, but retained the current religious exemption, the Centers for Medicare & Medicaid Services said previously.”

In judicial news,

  • Reuters lets us know,
    • “A federal judge in Texas ruled that Democratic President Joe Biden’s administration likely exceeded its authority by issuing a rule strengthening privacy protections for women seeking abortions and for patients who receive gender transition treatments.
    • “U.S. District Judge Matthew Kacsmaryk in Amarillo on Sunday [December 22] agreed to block the U.S. Department of Health and Human Services from enforcing the rule against a Texas doctor who through lawyers at a conservative Christian legal group challenged the regulation as unlawful.
    • “The ruling by Kacsmaryk, who was appointed by Republican President-elect Donald Trump in his first term, issued the preliminary injunction a day before a Monday deadline for the doctor, Carmen Purl and her business to comply with the rule.”
    • FEHBlog observation: As noted in the article, the preliminary injunction applies only to the plaintiff.

In Food and Drug Administration news,

  • Per an FDA press release,
    • “Today [December 23], the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
    • “The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
    • “Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.
    • “The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
  • STAT News reports,
    • “The FDA just approved Alyftrek, a once-daily medicine for a small slice of cystic fibrosis patients that carry certain mutations, including F508del. It’s a triple combination CFTR modulator that works across 31 other mutations, and outperformed Trikafta — another popular Vertex drug for cystic fibrosis — in its ability to reduce sweat chloride levels. This is the company’s fifth CFTR modulator to win U.S. approval.
    • “Vertex said that the drug offers simpler dosing for existing patients taking its drugs — but will be beneficial for an additional 150 U.S. patients with the disease, whose mutations are now treatable.”
  • Per Fierce Pharma,
    • “Undeterred by last year’s rejection and the recent approval of a close rival from Pfizer, Novo Nordisk has pushed its once-daily hemophilia injection across the regulatory finish line days before we hit 2025. 
    • “Late last week, Novo revealed that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist concizumab as a once-a-day treatment to prevent or curb the frequency of bleeding episodes in patients ages 12 and older who have hemophilia A or B with inhibitors.
    • “The prophylactic, which comes in prefilled, premixed pens for subcutaneous injection, will be marketed under the commercial title Alhemo, Novo said in a release.”

From the public health and medical research front,

  • Beckers Clinical Leadership offer five updates on the respiratory illness surge and six developments on bird flu as we head into the new year.
  • The American Medical Association fills us in on what doctors wish their patients knew about pneumonia.
  • Consumer Reports, writing in the Washington Post, relates “Things to do, and not to do, when you have a cut. Don’t “air it out.” Put down the hydrogen peroxide. Don’t bother with the antibiotic ointment. But do wash it and cover it.”

From the U.S. healthcare business front

  • Per Fierce Healthcare,
    • “Despite significant headwinds coming to bear over the past several years, healthcare executives are expecting a favorable 2025, according to a new survey from Deloitte.
    • “Deloitte’s Center for Health Solutions polled 80 C-level leaders at healthcare organizations, including 40 from health systems and 40 from health plans. Close to 60% said they believe the outlook for the coming year is favorable, increasing from 52% in last year’s survey.
    • “A majority (69%) said they believe revenues will grow in 2025, and 71% said they expect greater profitability.
    • “Two major themes emerged from executives in both sectors, according to Deloitte: growth and consumer affordability. In addition, insurance executives said they were gearing up for a year of regulatory change and new technological advancements, while health system leaders said they expect continued workforce challenges and enhancements to core business technologies.
  • Bloomberg reports,
    • “Republicans have a new chance to expand health savings accounts offered by employer plans when Congress reconvenes in 2025, revisiting a divisive policy that some Democrats support even as others denounce it as a tax break for the wealthy.
    • “Health savings accounts let high-deductible health plan enrollees use tax-free dollars on certain medical expenses. The money rolls over annually and can be invested tax-free for higher returns. Twenty-two percent of employers surveyed by the Kaiser Family Foundation offered HSA-eligible plans in 2024.
    • “Advocates see the tax-advantaged accounts as a vehicle to increase both health care access and conscious spending for high-deductible plan members, who pay more out-of-pocket before insurance kicks in. Lawmakers from both parties have proposed bills to allow patients to use HSAs for everything from gym memberships and menstrual products to funeral expenses and veterinary bills.” * * *
    • “Labeling HSAs as tools for the wealthy is a “mischaracterization,” said Johns Hopkins University accounting and health policy professor Ge Bai, pointing to data that show the majority of HSA holders live in zip codes where the median income is below $100,000. Loosening requirements around the accounts could be particularly useful for gig workers who lack insurance, she said.”
  • Beckers Hospital Review shares Mark Cuban’s plans for the new year.