Tuesday report

David Ermer–Congress, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “No more votes are scheduled beyond Wednesday in the House, a change from the previous schedule that reflects a Rules Committee dispute over release of the Jeffrey Epstein case files that will prevent any rules for debate from coming to the floor.
    • “The House is expected to continue to consider legislation under suspension of the rules through Wednesday afternoon but won’t have any more floor votes on Thursday.
    • “That’s a shift from Monday night when Speaker Mike Johnson, R-La., told reporters that the chamber would remain in session through Thursday because of suspension votes and committee meetings.”
  • Because the House of Representatives is scheduled to be on an August recess until September 2, 2025, the House Appropriations Committee will not be taking up the FY 2025 Financial Services and General Government appropriations bill until September.
  • The American Hospital Association News tells us, “The House Ways and Means Subcommittees on Health and Oversight held a joint hearing today to discuss lessons learned, challenges and opportunities to improve the Medicare Advantage program,” and “The AHA today expressed support for the Medicare Mental Health Inpatient Equity Act, a bill that would eliminate the 190-day lifetime limit on inpatient psychiatric hospital services for Medicare patients.” 
  • STAT News adds,
    • “Members of a [House Energy and Commerce oversight committee] said Tuesday that they fear public trust in organ donation has been fractured after a federal report found that an organ procurement organization ignored signs of life in patients when authorizing attempted organ removals.
    • “The hearing followed a federal investigation by the Health Resources and Services Administration that found that a group responsible for overseeing the removal of organs from deceased patients and getting them to patients in need exhibited “concerning patterns of risk to neurologically injured patients.” * * *
    • “During Tuesday’s hearing, lawmakers sharply questioned and criticized the practices of Network for Hope, the OPTN, and UNOS in conducting oversight of patient safety. The OPTN had launched a separate investigation into Network for Hope that was closed without further action.” 
  • Govexec informs us,
    • “The new, Senate-confirmed head of the Office of Personnel Management, venture capital alum Scott Kupor, says that he wants to operationalize the focus on efficiency in his agency and throughout government, but that OPM won’t be taking orders from the Department of Government Efficiency.
    • “OPM is its own agency,” Kupor told reporters Monday when asked about its relationship with DOGE moving forward. “To the extent that they’re helpful in the overall goals and objectives we have, then we’re happy to partner with people, but we’re going to ultimately make the decisions that we think are in the best interests of OPM.” * * *
    • “The agency is down by 322 employees since the start of Trump 2.0, OPM says. Once voluntary separations are finalized by the end of the year, OPM will be down from 3,110 employees when Trump took office to about 2,000, or around one-third of the agency, according to OPM.” * * *
    • “Kupor, who only started the job last week, said that he may have to make up for some of those losses. The agency is looking at what gaps in service exist, which need to be filled, which can be made up for with technology and what was “nice to have,” but not essential.” * * *
    • “We’ve got to really just rethink our entire recruiting efforts,” Kupor said. “I want every really smart person in this country to wake up every day and say, ‘you know what, I want to go work for the government because I can work on super hard problems that are very complex.’”
  • The AHA News relates,
    • “The AHA yesterday responded to a request for information from the Centers for Medicare & Medicaid Services on price transparency policy, specifically the accuracy and completeness of hospitals’ machine-readable files. The AHA said that determining the accuracy and completeness of machine-readable file data is challenging given that exact rates do not exist in the way they were envisioned by the policy. In addition, the AHA said that additional enforcement of hospital price transparency requirements is not necessary due to CMS’ improved enforcement efforts.  
    • “The AHA encouraged CMS to instead focus its efforts on the information that will best help patients understand and compare their expected costs prior to care and on streamlining price transparency policies to remove complexity and administrative burden.”

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “Women should be better informed about the potential risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy, and these risks should be weighed against their benefits, most speakers on an FDA panel selected by Commissioner Marty Makary, MD, MPH, agreed on Monday.
    • “Up to 5% of women in pregnancy are on an antidepressant. Antidepressants like SSRIs can be an effective treatment for depression,” said Makary during his opening remarks, though he warned that SSRIs “may be unique” because of their potential interaction with pregnancy.
    • “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain, and even the gut,” he continued. “SSRIs have also been implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension, and cognitive downstream effects in the baby, as well as cardiac birth defects.”
  • STAT News reports,
    • “Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and Drug Administration official told STAT, suggesting the treatment’s license could be revoked. 
    • “The official, who spoke to STAT on condition of anonymity, did not rule out the possibility that the therapy, Elevidys, could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.”

From the judicial front,

  • The Chief Judge for the Southern District of Iowa federal court entered a preliminary injunction today against certain provisions of a recently enacted Iowa PBM reform law that interfere with operations of ERISA governed health plans based on ERISA’s preemption law. The 87-page decision is well reasoned and quite balanced. What’s good for ERISA preemption is good for FEHB Act preemption.
  • Healthcare Dive reports,
    • “Humana on Monday refiled its lawsuit against the federal government for allegedly miscalculating its Medicare Advantage quality scores for 2025, after its previous suit was dismissed on procedural grounds.
    • “The new suit in a Texas district court is slimmer than its predecessor, focusing on allegations that regulators improperly dinged its plans’ star ratings on the basis of three mishandled customer service phone calls. The original suit made broader arguments about the integrity of the star ratings system and review process.”

From the public health and medical research front,

  • Cigna, writing in LinkedIn, discusses “the importance of treating both mental and physical health together.
  • USA Today lets us know,
    • “About five million swimming pools, specifically above-ground pools, have been recalled for a potential drowning risk after nine children died in a 15-year span.
    • “The impacted models include 48-inch and taller above-ground pools sold over the past two decades under the brand names Bestway, Coleman, Intex, and Polygroup, according to a release from the U.S. Consumer Product Safety Commission
    • “The CPSC believes between 2007 and 2022, nine children under 3 years old drowned after gaining access to the pools via compression straps that wrap around the outside of the product, according to the release.
    • “These straps wrap around the pool on the outside of the supporting poles, and may create a foothold, allowing a child to access the pool and drown,” the release said.”
  • STAT News reports,
    • “People suffering from long Covid finally had reason for hope: A German biotech had repurposed a drug candidate initially meant for heart disease as a potential treatment and enrolled patients in a rare double-blind Phase 2 study. For some participants, the results were transformative. One patient told Betsy Ladyzhets of The Sick Times that thanks to the infusion, BC 007, “I have literally regained life.”
    • “But last fall, the biotech company Berlin Cures abruptly announced the trial results were a failure, that it was out of money, and that it was done researching BC 007 as a treatment for long Covid. The story serves as a case study in the difficulty of developing long Covid therapies, as well as a window into the real-world impacts the hope and pain that clinical trials can inspire as they ramp up and then suddenly vanish. However, the drug may still have a future. Read more.“
  • and
    • “People with diabetes who were just a little physically active in their leisure time reduced their risk of dying from any cause — and from cardiovascular disease in particular — compared to people who weren’t active at all, according to a new Annals of Internal Medicine study that followed more than 51,000 people for 21 years. That benefit showed up for people who met the American Diabetes Association’s recommended 150 minutes of moderate to vigorous exercise a week over at least three days, but it was also apparent for “weekend warriors” who hit 150 minutes in just two days, matching research in people without diabetes. “Insufficiently active” types whose activity fell short of the 150 minutes per week also fared better than those who did no exercise.”
  • Per Medscape,
    • “Patients treated with tirzepatide have a significantly increased likelihood of attaining combined key therapeutic targets in the control of type 2 diabetes (T2D) compared with semaglutide, a post hoc analysis of the phase 3 SURPASS-2 trial showed. 
    • “In this post hoc analysis, we showed that tirzepatide was superior to semaglutide in achieving standard and intensive goals in type 2 diabetes control,” said first author Ana Rita Leite, MD, of the Department of Endocrinology, Diabetes, and Metabolism, São João Local Health Unit, Porto, Portugal, in presenting the findings at ENDO 2025: The Endocrine Society Annual Meeting.
    • “All doses of tirzepatide were superior in achieving these goals compared with semaglutide 1 mg, and there was a dose-dependent increase in the number of therapeutic goals attained with higher doses of tirzepatide,” she said.”
  • Per Health Exec,
    • “Researchers at the University of Florida College of Medicine have made a surprising finding that they say could “wake up” the immune system to fight cancer, possibly leading to a universal vaccine. 
    • “According to an announcement, a new study showed that an experimental vaccine developed using mRNA technology boosted tumor resistance in mice, when compared to a cohort that was given standard anti-cancer drugs. 
    • “The results seem to indicate the mice given the vaccine developed an immune response that allowed them to more effectively resist cancerous tumors. The findings were published in Nature Biomedical Engineering. [1]
    • “The promising results have spurred interest in how humans would react to the mRNA vaccine, with the researchers hoping it could be used as a treatment, either by itself or in conjunction with surgery, radiation and chemotherapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ahead of the company’s second-quarter earnings call Aug. 6, Oscar Health is slashing its full-year guidance by about half a billion dollars.
    • “The insurer is expecting a loss from operations of $200 million to $300 million just months after estimating earnings from operations of $225 million to $275 million, partly due to elevated utilization.
    • “Oscar’s medical loss ratio is also climbing to between 86% and 87%, more than 5% higher than initially proposed. Total revenue is projected to climb to no more than $12.2 million.
    • “Wakely, an actuarial firm analyzing claims submissions through the end of April for Affordable Care Act (ACA) marketplace carriers, determined marketplace risk scores have risen more than Oscar previously estimated. The company foresees a net loss of $228 million for the second quarter.
    • “We are taking appropriate pricing actions for 2026 that reflect higher acuity in the individual market, and we will continue to take steps to deliver for our members, partners, and shareholders,” said Oscar Health CEO Mark Bertolini in a statement. “Oscar has successfully navigated dynamic markets before, and we remain committed to our long-term strategy to bring more employees, individuals, and families healthcare choices that fit their needs through the individual market.”
  • Per Drug Channels,
    • “It’s time for Drug Channels’ annual update on drug pricing trends at the largest pharmaceutical manufacturers.
    • “This year’s review includes the following nine companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson & Johnson, Sanofi, Takeda, Teva, and UCB. You can find links to each company’s data below.
    • “These data highlight divergent trends reshaping the gross-to-net bubble:
      • “Rebates, discounts, and other fees reduced the selling prices of brand-name drugs at the biggest drugmakers to less than half of their list prices.
      • “When accounting for all list price reductions, average brand-name drug prices declined at four manufacturers and increased at five others. 
      • “Gross-to-net difference in price changes ranged from −12.8% to +4.2%, reflecting significant differences in the manufacturers’ portfolio mix and pricing strategies.”
  • Fierce Health adds,
    • “Humana is accelerating its efforts to reform the prior authorization process through a series of new policies, following the broader insurance industry’s recent pledge to reduce and streamline prior auth requirements.
    • “By January 1, 2026, Humana will eliminate one-third of prior authorization requirements for outpatient services, including for diagnostic services across colonoscopies, transthoracic echocardiograms, and select CT scans and MRIs. 
    • “Under the same timeline, the company is committing to providing decisions within one business day on at least 95% of all complete electronic prior authorization requests. Currently, a decision is provided within one business day on more than 85% of outpatient procedures.
    • “Also in 2026, Humana will launch a new gold card program that waives prior authorization requirements for certain items and services for providers with a record of submitting 
    • coverage requests that meet medical criteria and specific outcomes metrics for members.”
  • Fierce Pharma tells us,
    • “With the threat of tariffs looming for medicines imported to the United States, AstraZeneca has unveiled a plan to invest $50 billion in the country by 2030. The centerpiece of the effort is a drug substance manufacturing facility—the highest-priced plant in company history—that will be located at a yet-to-be-determined site in Virginia.
    • “The massive investment is part of a push by the company to generate $80 billion in sales by the end of the decade, with 50% of the haul coming in the United States. Last year, the British/Swedish company reported revenue of $54 billion, with U.S. sales accounting for 42% of the figure.”
  • BioPharma Dive reports,
    • “French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines.
    • “Through the deal, Sanofi will gain a combination shot now in clinical testing for protection against respiratory syncytial virus and human metapneumovirus, or hMPV. Vicebio specializes in a vaccine technology it dubs “molecular clamp.”
    • “Per deal terms, Vicebio could also receive up to $450 million in additional payments based on achievement of developmental and regulatory milestones. The companies expect the acquisition to close in the fourth quarter.”