Midweek Update

David Ermer–ACA, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “Healthcare facilities across the west coast of Florida, from clinics to nursing homes, are temporarily shutting their doors and evacuating patients in preparation for Hurricane Milton’s potentially devastating landfall.
    • “Mandatory evacuation orders in Pinellas County, which includes Clearwater and St. Petersburg, affect about 6,600 patients at six hospitals, 25 nursing homes and 44 assisted living facilities, according to the order. Scores of medical clinics and dialysis centers across the region have also closed, including dozens of outpatient facilities operated by the BayCare, a health care network.
    • “The region’s only Level 1 trauma center, Tampa General Hospital, has deployed a temporary flood barricade that officials hope will stave off the storm surge. Most of the hospitals in the region that are still open have suspended elective operations or have stopped accepting new patients.
    • “University of Florida Health, which operates about a dozen hospitals across the state, had enough food, water and fuel to keep its facilities operating for 96 hours, according to Peyton Wesner, a spokesman.”
  • and
    • “U.S. officials approved airlifts of IV fluids from overseas manufacturing plants on Wednesday to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.
    • “The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.
    • “The situation could become even more dire now that Hurricane Milton is hitting Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.
    • “The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit medical products.”
  • Here’s a link to an HHS Secretary letter to healthcare leaders about the IV fluid shortage, and Beckers Payer Issues offers five notes on insurer response to Hurricane Milton.
  • Kevin Moss, writing in Govexec, takes a closer look at 2025 FEHB premiums.
  • CMS has issued a memorandum with payment parameters guidance for the 2026 plan year
    • The 2025 maximum limit on cost sharing for FEHB and other group plans is $10.150 for self only coverage and $20,300 for other than self only coverage. These limits represent approximately a 10.3% increase over the 2025 maximum limits of $9,200 for self only coverage and $18,400 for other than self only coverage.
  • “The International Foundation of Employee Benefit Plans shares links to the final 1094-B, 1095-B, 1094-C, and 1095-C forms [and instructions] that employers, plan sponsors and group health insurers will use to report 2024 health coverage to plan members, and the IRS as required by the Affordable Care Act (ACA).” 
  • STAT News tells us,
    • “A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released a request for information and a sample list of prescription drugs it intends to include under a proposed Medicare $2 Drug List Model. Under the model, people enrolled in a Part D plan would have access to these drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug. The model would provide individuals more certainty about out-of-pocket costs for these generic covered drugs that would target common conditions such as high cholesterol and high blood pressure. The Center for Medicare and Medicaid Innovation’s model aims to test whether a simplified approach to offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes and improve satisfaction with the Part D prescription drug benefit among Medicare beneficiaries and prescribers. It is also aligned with Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which directed the creation of new payment models to lower drug costs and promote access. Comments are due Dec. 9 through a CMS survey.”
  • KFF provides us with “A Current [Detailed] Snapshot of the Medicare Part D Prescription Drug Benefit.”
  • The Wall Street Journal reports,
    • “CVS Health filed a motion seeking to disqualify top Federal Trade Commission officials from participating in a case regarding some of its businesses over alleged bias against pharmacy benefit managers.
    • “The healthcare company said Chair Lina Khan, Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya through public statements show they have prejudged the matter at hand and that their participation would violate the due process rights of respondents Caremark Rx and Zinc Health Services.
    • “CVS specified that past statements made false assertions that are critical to the merits of the case, including that pharmacy benefit managers “control” drug pricing and patient access to drugs including insulin.
    • “Cigna Group, on behalf of Express Scripts and other of its businesses, also filed a motion seeking to disqualify Khan, Slaughter and Bedoya.
    • “UnitedHealth Group, who reportedly filed a similar motion, didn’t immediately respond to a request for comment.”

From the public health and medical research front,

  • STAT News points out,
    • “A trio of scientists who opened new doors in our understanding of the structure of proteins — the fundamental building blocks of biology — and even came up with ways to create new proteins won the Nobel Prize in chemistry Wednesday.
    • “The prize went to David Baker of the University of Washington, and to Demis Hassabis and John Jumper, who work at Google DeepMind in London. Baker will receive half the 11 million Swedish kronor (just over $1 million) prize, while Hassabis and Jumper will split the other half.” * * *
    • “Baker said he was sleeping when he received the Nobel call early Wednesday morning, as is often the case for laureates in the U.S. When he was told he had won the prize, his wife started yelling, drowning out the person on the phone. He had to go to another room so he could hear the rest of the call, he said. 
    • “Asked by one journalist to pick his favorite protein, Baker demurred, saying he didn’t want to identify just one. But he did highlight one that he and his colleagues had crafted that could potentially block the coronavirus behind Covid-19 from infecting cells, hinting at one of the applications of his discoveries that researchers are now pursuing. 
    • “I’ve been very excited about the idea of a nasal spray of little designed proteins that would protect against all possible pandemic viruses,” he said.”
  • Kudos to the recipients.
  • The American Medical Association tells us what doctors wish their patients knew about microplastics.
  • The National Cancer Institute shares its Cancer Information Highlights about “Breast Cancer | Jaw Necrosis | Leiomyosarcoma.”
  • Per National Institutes of Health press release,
    • “The National Institutes of Health has launched a nationwide consortium to address the dramatic rise in youth diagnosed with type 2 diabetes over the past two decades, a trend that is expected to continue. The effort aims to advance understanding of the biologic, social, and environmental drivers of youth-onset type 2 diabetes, with the goals of determining which children are at highest risk for developing the disease and how to better prevent, screen for, and manage type 2 diabetes in young people.
    • “Our children who are overweight or have obesity are at risk, but we don’t know how best to identify the children who will progress to type 2 diabetes,” said Rose Gubitosi-Klug, M.D., Ph.D., study lead, and chief of pediatric endocrinology at Case Western Reserve University/Rainbow Babies and Children’s Hospital, Cleveland. “This study will bring us closer to our goal of prevention of type 2 diabetes in future generations of youth.” * * *
    • “For more information about the study, known as DISCOVERY of Risk Factors for Type 2 Diabetes in Youth, please visit discovery.bsc.gwu.edu.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “The average annual premium for employer-sponsored family health coverage rose 7% in 2024 to $25,572, according to the latest KFF annual survey. It is the second consecutive year with a 7% increase. For workers who have an annual deductible for single coverage, the 2024 average is $1,787, similar to last year’s $1,735 and up 8% from 2019. The survey found that the amount workers’ pay toward annual premiums has increased less than 5% since 2019, which may be due to a tight labor market.”
  • Per Beckers Hospital CFO Report,
    • “Chicago-based CommonSpirit is “investing significantly in high-growth markets,” such as Arizona and Colorado, to ensure the long-term sustainability of the health system, CFO Dan Morissette said during the company’s investor call on Oct. 4.
    • “Last year, Centennial, Colo.-based Centura Health folded into CommonSpirit, which manages 20 hospitals and more than 240 care sites in Colorado, Kansas and Utah that were previously managed by Centura. 
    • “The news came shortly after CommonSpirit and Altamonte Springs, Fla.-based AdventHealth said they would end their Centura Health joint venture after 27 years, with each system directly managing their respective care sites in Kansas and Colorado. 
    • “Much of our focus in this market is on transition alignment and ambulatory care sites, as well as future inpatient growth to meet the rapidly expanding demand,” Mr. Morissette said. “We also announced a partnership with Kaiser in this market, which is an important new collaboration for us.Intentional capital deployment means taking a system-level approach to reviewing and 
    • “CommonSpirit is also diversifying its service line in these high-growth markets. Areas of focus include behavioral health, cancer care and outpatient care.”
  • Per Fierce Pharma,
    • “GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.
    • “The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S., most of which had been consolidated in Delaware. The settlement was reached with 10 plaintiff firms with the agreement that GSK does not admit liability, the company said.
    • “With the deal, lawyers representing the plaintiffs are unanimously recommending that clients accept terms of the settlement, which is expected to be complete by the end of the first half of 2025, GSK said.
    • “The agreement is in line with a similar settlement Sanofi reportedly made earlier this year. The French pharma consented to pay $100 million to resolve roughly 4,000 Zantac claims, Bloomberg reported in April. That deal paid plaintiffs roughly $25,000 each. The GSK settlement comes to approximately $27,500 per claimant.
    • ‘In May of this year, Pfizer also settled approximately 10,000 Zantac lawsuits for an undisclosed figure. Pfizer had the rights to sell the antacid from 1998 to 2006.
    • “In addition to the $2.2 billion deal, GSK also said on Wednesday that it will pay $70 million to resolve a qui tam complaint filed by Connecticut-based laboratory Valisure, which first raised alarm bells about Zantac’s risks in 2019 during routine batch testing.”
  • Per MedTech Dive,
    • “The number of medical devices with artificial intelligence technology has risen sharply in the past decade. 
    • “The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked in recent years.
    • “In 2015, the FDA authorized six AI medical devices. In 2023, the agency authorized 221 devices, according to data reviewed by MedTech Dive.
    • “The trend has been driven by more connected devices, more investment into AI and machine learning and growing familiarity with how software is regulated as a medical device, experts said in interviews.
    • “We’re definitely seeing huge increases in investment. There’s no doubt about that,” said Jennifer Goldsack, CEO of the Digital Medicine Society, an industry group for digital health.”