Midweek Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Roll Call reports
    • “House Majority Leader Steve Scalise’s bid for speaker was on shaky ground Wednesday as Republicans went back behind closed doors to figure out next steps even after selecting the Louisianan as their nominee during a morning conference meeting.
    • “Several conservatives said they won’t support Scalise on the floor, even as his top rival for the job, Judiciary Chairman Jim Jordan, R-Ohio, is supporting him and encouraging others to do so. Instead of kicking off the formal nominating speeches and votes on the floor Wednesday after coming into session at 3 p.m., Speaker Pro Tempore Patrick T. McHenry recessed the chamber.” * * *
    • “The House adjourned for the night before 7 p.m. An advisory from House Democrats said votes were “possible” Thursday, and the chamber is scheduled to gavel back into session at noon.”
  • On September 18, 2023, the Senate Health Education Labor and Pensions Committee will hold a hearing on the nomination of Dr. Monica Bertagnolli to be Director of the National Institutes of Health.
  • Govexec tells us,
    • “The Biden administration on Wednesday released a new requirement for agencies throughout government to think more carefully about expanding competition through their regulatory actions. 
    • “President Biden has targeted antitrust trends in the economy as a key part of his domestic agenda and the White House said the new guidance will help enforce those efforts through an “all-of-government approach to competition.” The Office of Information and Regulatory Affairs document creates frameworks for agencies as they develop and analyze potential regulatory actions. 
    • “OIRA noted that agencies can shape markets through their regulations and urged them to draft those rules to enhance competition.” 
  • Federal New Network explores the role of Janice Underwood, the first-ever governmentwide chief diversity officer and a senior leader at the Office of Personnel Management.

From the public health and research front,

  • KFF informs us,
    • “Sepsis, the body’s extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient’s chance of survival. Yet sepsis can be difficult to diagnose because some patients don’t present with common symptoms like fever, rapid heart rate, or confusion.
    • “A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis, and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
    • “Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
    • “Efforts to reduce sepsis deaths are welcome, but “where it gets controversial becomes ‘Is this the best way to do it?’” said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.”
  • Reuters reports,
    • “Novo Nordisk (NOVOb.CO) said on Tuesday it will stop a trial studying Ozempic to treat kidney failure in diabetes patients ahead of schedule because it was clear from an interim analysis that the treatment would succeed.
    • “Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug is going to succeed or fail based on interim analyses. * * *
    • “The Danish drugmaker said the trial was testing whether the widely used diabetes drug, which contains the active ingredient semaglutide, could delay the progression of chronic kidney disease and lower the risk of death from kidney and heart problems.
    • “Semaglutide is also the active ingredient in Novo Nordisk’s powerful weight-loss drug Wegovy.
    • “Barclays analyst Emily Field said in a note that the company’s decision affirmed the view that GLP-1 receptor agonists like Ozempic have “therapeutic benefits far beyond their original intended purpose.”
    • FEHBlog note — Why then doesn’t Novo Nordisk lower the price of this apparent cure-all?
  • Medscape adds,
    • “People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.
    • “Patients” taking either of these glucagon-like peptide-1 (GLP-1) receptor agonists had nine times an elevated risk for pancreatitis. They were also four times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.
    • “The research letter was published online today in the Journal of the American Medical Association.
    • “Investigators say their findings are not about scaring people off the weight loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.
    • “* * * People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially for lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”
    • “People taking these drugs for weight loss have an approximately 1%–2% chance of experiencing these events, including a 1% risk for gastroparesis, Etminan said.”
  • The Brown & Brown consulting firm offers a four-step plan for employer action to “focus on their benefits, helping to enable employees with easy access to preventive care, early detection, navigation and support specific to breast cancer.
  • The New York Times points out,
    • “The Food and Drug Administration issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety, post-traumatic stress disorder and other difficult-to-treat mental health problems.”
  • and
    • “A new AI tool diagnoses brain tumors on the operating table;
    • “A new study describes a method for faster and more precise diagnoses, which can help surgeons decide how aggressively to operate.”

From the U.S. healthcare business front,

  • The VTDigger lets us know that following regulatory approval, “Blue Cross Blue Shield of Vermont can now move forward with an agreement that will make the Berlin-based nonprofit a subsidiary of the much larger Blue Cross Blue Shield of Michigan.”
  • Per Fierce Healthcare
    • “Des Moines, Iowa-based UnityPoint Health and Albuquerque, New Mexico-based Presbyterian Healthcare Services are no longer working toward a merger, the systems announced Wednesday.”
  • and
    • A new analysis finds that more pharmacists are electronically prescribing medications as they assist in managing chronic disease, which offers a peek at the next evolution in primary care.
    • * * * Lynne Nowak, M.D., Surescripts’ first chief data and analytics officer, told Fierce Healthcare in an interview at HLTH that the findings highlight the potential pharmacists and other clinicians have in addressing those access gaps.
    • “We’re not saying that pharmacists should be doing the job of a physician,” Nowak said. “They’re not trying to replace them, but just looking at this broader view of a care team and ensuring they’re all connected.”
  • STAT News reports,
    • “Bruce Broussard, CEO of health insurance giant Humana, will step down next year after leading the company for more than a decade.
    • “Humana named Jim Rechtin — who is the CEO of Envision Healthcare, the controversial physician staffing firm that is working its way through bankruptcy — as Broussard’s replacement. Rechtin will serve as president and chief operating officer starting Jan. 8 and then take over as CEO in the “latter half of 2024,” the company said in a news release.”
  • Per Healthcare Dive,
    • “Walgreens has named former Cigna executive Tim Wentworth as its new chief executive officer, the retail pharmacy company announced late Tuesday.
    • “Wentworth is replacing Roz Brewer a little over a month after she announced her unexpected departure from Walgreens.
    • “Wentworth, who will become Walgreens CEO effective Oct. 23, is the former CEO of Express Scripts, the pharmacy benefit manager acquired by Cigna in 2018. At Cigna, he led the health services business Evernorth.”
  • and
    • “CVS Health wants to create a “super app” connecting multiple omnichannel modalities of the healthcare experience, including benefits, delivery and retail channels, chief medical officer Sree Chaguturu said Tuesday at the HLTH conference in Las Vegas.
    • “A super app is a widely adopted mobile or web application that combines multiple services in one platform. Super apps are ubiquitous in Asia, but haven’t taken off in the U.S. due to a fragmented app market, concerns about advertising revenue, the country’s payment system structure and a strict regulatory environment, according to the Harvard Business Review.”
  • The WTW consulting firm offers an infographic displaying the results of their employer survey of Best Practices in Healthcare.