Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump stuck to his July 4 deadline for Republicans’ tax-and-spending megabill while signaling there might be some wiggle room as GOP senators struggled to resolve disagreements over Medicaid cuts and other provisions.
    • “Senators said they were aiming for an initial procedural vote as early as noon Saturday, which would let them pass the bill sometime Sunday. Before that, they are aiming to release the final text of the bill and ensure that it can work procedurally in the fast-track process they are using for the party-line legislation.
    • “As of Friday afternoon, Senate Republicans were still negotiating details over the state and local tax deduction, considering a new proposal to set the cap at the House-preferred level of $40,000 for five years before it shrinks. They are also debating changes to Medicaid, including limits on state-financing mechanisms that could squeeze rural hospitals—and a rural-hospital fund to mitigate the effects of their plans. 
    • “Asked at a press conference if he was sticking with his Independence Day target, Trump said: “It’s not the end-all. It could go longer, but we’d like to get it done.”
  • Federal News Network tells us,
    • “A bipartisan bill to revise the rules for federal workers’ compensation cases unanimously advanced out of a House committee this week. The legislation would revise the Federal Employees’ Compensation Act to allow physician assistants and nurse practitioners to treat feds in workers’ compensation cases. A previous version of the bill passed the House in 2022, but did not clear the Senate. Cosponsors of the bill say they’re hopeful it will pass both chambers this Congress.”
  • Per a CMS news release,
  • Fierce Pharma informs us,
    • “Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now.
    • “The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency said Thursday.
    • “Existing commercial CAR-T products, including Bristol Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah, stand to benefit from the update. Autolus’ CD19 CAR-T Aucatzyl was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement. The FDA’s website only has updated prescribing information for Carvykti as of publication time, but the agency’s announcement said the REMS requirements have been removed for all these drugs.” * * *
    • “These changes should facilitate patient access, particularly for those who do not live near centers of excellence where CAR-Ts are commonly administered,” Citi analysts wrote in a Friday note.”
  • Federal News Network notes,
    • “June 28th is National Insurance Awareness Day, offering a timely reminder for federal employees to reassess their current healthcare needs and determine whether their FEHB plan remains the best fit.
    • “It’s important to review your coverage outside of Open Season, know what to expect for 2026, and be aware of trusted resources that can help guide your decisions.”
    • The article shares information on these points.

From the judicial front,

  • The Supreme Court completed its October 2024 term today.
  • Roll Call reports,
    • The Supreme Court curtailed the power of district courts to issue “universal injunctions” in a decision Friday in the legal clash over the Trump administration’s push end birthright citizenship.
    • The 6-3 decision [liberals dissenting] found that most of those broad orders that stop government actions — and there have been dozens issued against the Trump administration this year — exceed the power Congress gave to federal district courts.
    • The decision sends litigation over the legality of President Donald Trump’s birthright citizenship effort back to the lower court and is likely to set off an avalanche of litigation in more than 100 lawsuits against Trump’s administrative actions.
  • The FEHBlog expects that plaintiffs will be converting their lawsuits to class actions.
  • Govexec adds,
    • “The Supreme Court on Friday limited individual judges’ capacity to strike down government policy on a nationwide basis, a decision with potentially far-reaching impacts on how federal agencies carry out their work. 
    • “The high court left in place some carve outs, however, including one that could—at least temporarily—protect a judge’s ruling that is currently blocking the Trump administration from carrying out widespread layoffs. While the Trump administration applauded the Supreme Court’s decision and lamented the influence that lower-level judges have exerted over the president’s control of the federal workforce, attorneys who helped bring the lawsuit forward suggested it did not apply to the order preventing large-scale reductions in force.” * * *
    • “The victory for federal employees, to the extent they can claim one after the Supreme Court’s decision, may be short lived. The administration has already appealed both RIF cases to the [Supreme Court], where it is now awaiting resolution. It has done so seeking emergency relief and a decision is expected any day.” 
       
  • The Wall Street Journal sums it up as follows:
    • The Supreme Court ruled against nationwide injunctions, limiting the scope of lower-court rulings against presidential policies.
    • The high court ruling might lead to more lawsuits against the administration, as individuals and groups must bring their own cases.
    • Lawyers are exploring class-action suits, and state attorneys general might gain influence challenging White House policies.
  • The American Hospital Association News relates,
    • “The Supreme Court today voted 6-3 [conservatives dissenting] to uphold an Affordable Care Act provision creating an independent task force charged with making recommendations of preventive services that insurers must cover at no cost. The ruling reverses a June 2024 decision by the U.S. Court of Appeals for the 5th Circuit, which partially affirmed a district court judgment that the U.S. Preventive Services Task Force, the group charged with determining coverage of certain preventative services, was unconstitutional.” 
    • The Court held that the USPSTF members, who are volunteers, are inferior officers of the United States, who can be appointed by someone other than the President, in this case, the HHS Secretary, without Senate confirmation.
    • The opinion helpfully preserves the ACA preventive care status quo.
  • KFF calls attention to legal issues that the Court’s opinion may not have resolved.
  • SCOTUSblog covers the other Supreme Court decisions issued today.
  • The AHA News also tells us,
    • “A U.S. District Court for the District of Columbia judge today ruled against Johnson and Johnson and sided with the Department of Health and Human Services and hospitals in a lawsuit brought by J&J challenging the government’s authority to reject J&J’s proposed 340B rebate model.  
    • “In sum, based on the plain and unambiguous language of the 340B statute, and supported by its purpose and history, HRSA has the authority to ‘provide’ for discounts, rebates, or both,” Judge Rudolph Contreras wrote. “This conclusion defeats J&J’s claim that HRSA lacked the authority to require prior approval of J&J’s rebate model.” 
    • “The AHA in a friend-of-the-court brief urged the court to uphold the government’s decision to reject J&J’s proposed 340B rebate model. Others joining the AHA in the filing were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals. 
    • “Earlier this year, a second district judge reached the same conclusion in cases brought by five other drug companies.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity is low. COVID-19 and RSV activity is very low.
    • “COVID-19
      • “COVID-19 wastewater activity, emergency department visits and laboratory percent positivity are at very low levels.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • Per Health Day,
    • “Updated COVID-19 vaccines are keeping up with new coronavirus strains and remain effective for keeping people out of the hospital, a new study says.
    • “The study, which examined the effectiveness of the 2023-2024 COVID vaccines against the XBB and JN.1 Omicron variant waves, found that the updated shots caused:
      • “A 24% lower risk of ER and urgent care visits related to COVID.
      • “A 29% lower risk of hospitalization.
      • “A 48% lower risk of ICU admission or death in hospital.
    • “This protection stretched from a week after vaccination out to 299 days afterward, researchers reported June 25 in JAMA Network Open.
    • “Maximum protection came during the first two months after vaccination, reducing severe cases of COVID by up to 68%, results show.
    • “However, vaccine effectiveness waned over time, particularly beyond the six-month mark.”
  • The University of Minnesota’s CIDRAP reports,
    • “The US Centers for Disease Control and Prevention (CDC) is now updating its measles totals on Wednesdays, and on June 25 it reported 13 more cases, putting the national total at 1,227 in 37 states. The nation’s cases are just 48 cases shy of passing the record number of cases reported in the 2019 surge, which was the most since measles was eliminated in the United States in 2000.
    • “The number of outbreaks remained at 23, and 89% of the confirmed cases are linked to outbreaks. Of the confirmed case-patients this year, 95% were unvaccinated or have an unknown vaccination status. So far, 148 people have been hospitalized, and the number of deaths remains at 3.”
  • and
    • “The percentage of US adults reporting high confidence in the Centers for Disease Control and Prevention (CDC) fell from 82% in February 2020 to 56% in June 2022, along with decreasing trust in other US health institutions, according to a study yesterday in PLOS Global Public Health.
    • “For the study, researchers from the University of Texas Southwestern Medical Center in Dallas conducted four surveys from February 2020 to October 2024 that assessed Americans’ confidence in US health institutions including the CDC, National Institutes of Health (NIH), Department of Health and Human Services (HHS), state and local health departments, professional medical organizations, the White House, and their own doctor. Sample sizes were 718, 672, 856, and 828, respectively.
    • “All four surveys asked participants their perceptions of public health organizations and who they thought should lead the US response to infectious disease outbreaks. Surveys 1 and 2 also asked questions on the COVID-19 pandemic, while surveys 3 and 4 asked questions around the 2022 and 2024 mpox outbreaks.” * * *
    • “The rate of those expressing high confidence then rebounded only slightly, to 60%, in October 2024.” * * *
    • “In a press release from PLOS, which published the journal, first author Hannah Melchinger says, “We need to take this decline seriously if we want to preserve the credibility of these entities and their public health recommendations.”
  • Per MedPage Today,
    • “Maternal flu vaccination was associated with a reduced risk of influenza infection during infants’ first 6 months of life, an age when they are too young to be vaccinated, a cohort study of nearly a quarter-million women and their babies found.
    • “Flu vaccination during pregnancy was associated with an adjusted 44.4% (95% CI 31.4-54.9) reduction in the risk of infant influenza infection, with protection strongest during the infants’ first few months of life, reported researchers led by Ousseny Zerbo, PhD, of Kaiser Permanente Northern California (KPNC) in Oakland, in Obstetrics & Gynecology.”
  • Health Day notes,
    • “People living with an autoimmune disease are nearly twice as likely to suffer from mood problems like depression, anxiety or bipolar disorder, a new large-scale study says.
    • “The risk of mood disorders is 87% to 97% higher in people suffering from rheumatoid arthritis, inflammatory bowel disease, lupus, multiple sclerosis, psoriasis and Graves’ syndrome, researchers reported June 24 in the BMJ Mental Health.
    • “This risk remains higher even after accounting for other factors like age, income and family history of psychiatric disorders, researchers found.
    • “Together, these results support the hypothesis that exposure to chronic inflammation may be associated with a greater risk for affective disorders,” concluded the research team led by Arish Mudra Rakshasa-Loots with the University of Edinburgh Center for Clinical Brain Sciences in the U.K.”
  • UConn which the FEHBlog’s alma mater writes in Linked In,
    • “Millions of Americans suffer from osteoarthritis, a painful joint disease that wears down cartilage and can severely impact mobility. Pain medications only mask symptoms, and surgical option carry risks of infection and immune rejection.
    • “At the University of Connecticut, a research team led by Thanh Nguyen, associate professor of mechanical engineering and biomedical engineering, believes the future of joint repair might lie in a tiny electrical spark—and a simple injection.
    • “Backed by a $2.3M grant from the National Institutes of Health (NIH) and National Institute of Biomedical Imaging and Bioengineering (NIBIB), Nguyen and his team are developing an injectable hydrogel designed to stimulate cartilage regeneration in large animal models.
    • “With current treatments, we’re managing the pain, not healing the tissue,” says Nguyen. “We’re hoping that the body’s own mechanical movements—like walking—can generate tiny electrical signals that encourage cartilage to grow back.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know about nine major hospital construction projects unveiled or advanced this year and notes that “Eliminating a $45 out-of-pocket fee for 3D mammography, also called digital breast tomosynthesis, increased utilization of the procedure by 7.8%, according to a study published June 19 in the Journal of the American College of Radiology.” 
  • Per HealthLeaders,
    • “Hospital at Home, which aims to treat selected patients at home with a combination of virtual care, remote patient monitoring and daily in-person visits instead of keeping them in the hospital, took off during the pandemic, with support from a waiver that enabled health systems and hospitals following the CMS model to receive Medicare reimbursement. That waiver is due to expire in September, and while there’s a strong lobbying effort to make it permanent, many hospital executives have said the program has proven its value and will go on regardless.”
  • Fierce Pharma discusses expert views on the status of the compounding industry now that the shortage of Novo and Lilly GLP-1 drugs is over.
  • Healthcare Dive reports,
    • “Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers’ chokehold on the U.S. drug market, experts said during a drug pricing transparency forum in Washington, D.C. this week.”
    • The FEHBlog thinks that this is Pharma distraction.

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