From Washington, DC

• Congress remains on the campaign trail until the lame duck session begins November 12.

• On October 7, the Supreme Court invited the Solicitor General to file a brief in a Tenth Circuit ERISA preemption case, Mulready v. PCMA, No. 23-1213, expressing the views of the United States. The case bears on FEHB preemption of state PBM laws regulating PBM contracts with FEHB carriers. Because the national election will result in a new President on January 20, 2024, it’s likely that the Solicitor General will not submit a brief in this case until next Spring.

• Beckers Payer Issues offers a useful perspective on HHS OIG and other investigative reports alleging that Medicare Advantage plans game the Medicare program by arranging for plan nurses to visit plan members to conduct health risk assessments.
  • “In a statement published Oct. 24, Mary Beth Donahue, president and CEO of the Better Medicare Alliance, said the report “paints a misleading picture of in-home health assessments.” 
  • “The Better Medicare Alliance is backed by major insurers. 
  • “Medicare Advantage is designed to achieve a better overall understanding of individuals’ health, and in-home assessments are a crucial part of this model,” Ms. Donahue said. “This information ensures seniors get the resources they need. We have supported codified best practices for these assessments and will continue to do so.” 
  • “In an Oct. 24 statement, AHIP, the trade association representing insurers, said CMS did not concur with key recommendations in the OIG’s report. 
  • “The agency did not concur with recommendations from the OIG to restrict payments for diagnoses found during in-home visits. 
  • “In its statement, AHIP said that health risk assessments are “one of many tools” MA plans use to identify chronic conditions and prevent these conditions from becoming more serious. 
  • “Whether they occur in the patient’s home or in a clinical office setting, the HRA offers an opportunity for the health plan and provider to obtain a complete evaluation of the patient’s physical, behavioral, and mental health needs, medications, health risks, and environmental factors that affect health,” the association said.” 

• Cardiovascular Business tells us,
  • “Medtronic has received U.S. Food and Drug Administration (FDA) approval for its new Affera mapping and ablation system with the Sphere-9 catheter, an all-in-one electrophysiology offering capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation. The system was approved to treat persistent atrial fibrillation (AFib) and cavotricuspid isthmus-dependent atrial flutter. It previously received CE mark approval in March 2023.
  • “Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of AFib. The company’s PulseSelect PFA system gained FDA approval in December 2023. 
  • “The Sphere-9 catheter at the heart of this system includes a 9 mm lattice tip designed to deliver wide-area circumferential ablations. It can provide either pulsed field or RF energy, a feature that puts more treatment options at the fingertips of operators than other commercially available PFA offerings. 
  • “The significance of this innovative technology should be underscored; Affera is a game changer for treatment of AFib and atrial flutter,” Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City and a known leader in ablation technologies, said in a statement. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of AFib.”

From the public health and medical research front,

• The AP reports,
  • “McDonald’s announced Sunday that Quarter Pounders will again be on its menu at hundreds of its restaurants after testing ruled out beef patties as the source of the outbreak of E. coli poisoning tied to the popular burgers that killed one person and sickened at least 75 others across 13 states.
  • “The U.S. Food and Drug Administration continues to believe that slivered onions from a single supplier are the likely source of contamination, McDonald’s said in a statement. It said it will resume selling the Quarter Pounder at affected restaurants —- without slivered onions — in the coming week.
  • “As of Friday, the outbreak had expanded to at least 75 people sick in 13 states, federal health officials said. A total of 22 people had been hospitalized, and two developed a dangerous kidney disease complication, the Centers for Disease Control and Prevention said. One person has died in Colorado.”

• Fortune Well identifies 17 factors that may play a role in whether a person suffers a stroke.
  • Stroke rates are rising, with over half a million Americans having a first stroke every year. But up to 80% of strokes may be preventable, which is why it’s so important to understand and mitigate your risk factors.
  • That’s according to the American Stroke Association, which this week released its first new clinical guidelines for strokes in a decade. 

• Fortune Well also shares four lessons about “leadership, parenting, and setbacks” that the UPS Stores president learned from suffering a severe heart attack at age 47.
  • “Sarah Casalan remembers several clear details from the night of her heart attack two years ago: First, she kept thinking she had indigestion from the hamburger she’d made herself for dinner the night before, though it was unusual, considering her “iron stomach.” But then she felt so awful that she lay on the bathroom floor, sweaty and nauseous, for over an hour—and found she could not get up.
  • “That was when the alarm bells went off, though I couldn’t, even at that moment, imagine I was having a heart attack,” says Casalan, president of the UPS Store Inc. and a single mom to two boys who were 6 and 7 at the time. After all, she was just 47, active, and in generally good health. “And why would I think I was having a heart attack without chest pain?” 
  • “Casalan eventually got herself up and to her mom, who happened to be visiting that night, and from there “it was a total of about five minutes between the realization that I could be having a heart attack to unconsciousness.” Turns out she was suffering from full blockage in her left ascending artery—prompting a heart attack known as a “widowmaker”—which has just a 12% survival rate outside of hospitals for women. (Doctors have since theorized that it could’ve been brought on by having had an “overly inflamed” heart after a bout with COVID.)”

• Per Medscape,
  • “A new study provides real-world evidence to support the potential repurposing of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetesand obesity, for prevention of Alzheimer’s disease (AD). 
  • “Adults with type 2 diabetes who were prescribed the GLP-1 RA semaglutide had a significantly lower risk for AD compared with their peers who were prescribed any of seven other antidiabetic medications, including other types of GLP-1 receptor–targeting medications. 
  • “These findings support further clinical trials to assess semaglutide’s potential in delaying or preventing AD,” the investigators, led by Rong Xu, PhD, with Case Western Reserve School of Medicine, Cleveland, Ohio, write. 
  • “The study was published online on October 24 in Alzheimer’s & Dementia.”
• and
  • “For patients with metabolic dysfunction–associated steatotic liver disease (MASLD) and diabetes, treatment with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) may protect against progression to cirrhosis and mortality; however, the protective benefits do not extend to patients who already have cirrhosis, a new study found.”
    
• The Wall Street Journal reports,
  • “Imagine being able to control a computer with your thoughts—even more easily and quickly than using your hands. That is the goal of Precision Neuroscience. Using brain-computer interfaces, it aims to transform the lives of people with physical challenges.
  • “The Wall Street Journal’s Rolfe Winkler spoke with Michael Mager, co-founder and chief executive of Precision Neuroscience, and Benjamin Rapoport, the company’s co-founder and chief science officer. [The article provides] edited excerpts of their discussion at the annual WSJ Tech Live conference.

From the U.S. healthcare business front,

• Fierce Healthcare lets us know,
  • “HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.
  • “The for-profit health system told investors on Friday morning that it expects to feel the effects of the two storms in the fourth quarter as well, with additional hurricane-related costs likely to be between $200 million and $300 million, according to a press release.
  • “HCA noted that these projections do not account for insurance recoveries it may receive.” 

• ‘Beckers Payer Issues tell us,
  • “Eighteen insurers have exited Medicare Advantage markets for 2025, with more than 1.8 million people currently enrolled in plans that will not exist next year, according to OliverWyman.
  • “Market exits by Humana, Aetna, and UnitedHealthcare collectively affect nearly 70% of those 1.8 million individuals.
  • “It’s important to highlight that these plan exits reflect members who will not be automatically moved into other products, even if one was available,” OliverWyman analysts wrote. “While these plan exits may seem alarming, carriers in many of these markets have introduced new products or have other products that members can switch to for 2025.”

• Per Beckers Hospital Review,
  • ‘U.S. Bankruptcy Court Judge Christopher Lopez approved the sale of seven Dallas-based Steward Health Care hospitals to Healthcare Systems of America, an affiliate of Glendale, Calif.-based American Healthcare Systems during an Oct. 25 court hearing.
  • “Steward sought Chapter 11 protection May 6 and has been working to sell its 31 hospitals.
  • “The Steward hospitals are Houston-based St. Joseph Medical Center, Port Arthur-based Medical Center of Southeast Texas, Coral Gables (Fla.) Hospital, Hialeah (Fla.) Hospital, Miami-based North Shore Medical Center, Lauderdale Lakes, Fla.-based Florida Medical Center and Hialeah, Fla.-based Palmetto General Hospital. 
  • “Healthcare Systems of America has been interim manager of the hospitals and Steward’s West Monroe, La. -based Glenwood Regional Medical Center since Sept. 11.”