From the No Surprises Act front,

• The American Hospital Association informs us,
  • “The U.S. District Court for the Eastern District of Texas, for a third time, ruled to set aside certain regulations implementing the No Surprises Act. In this case, the Texas Medical Association, joined by several air ambulance providers and supported by an amicus filed by the AHA, successfully argued that the methodology for how insurers calculate the qualifying payment amount tilts the arbitration process in insurers’ favor.” 
• The Centers for Medicare and Medicaid Services adds,
  • “On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services, Case No. 6:22-cv-450-JDK (TMA III), vacating certain portions of 86 Fed. Reg. 36,872, 45 C.F.R. § 149.130 and 149.140 , 26 C.F.R. § 54.9816-6T and 54.9817-1T, 29 C.F.R. § 2590.716-6 and 2590.717-1, and 5 C.F.R. § 890.114(a) as well as certain portions of several guidance documents. As a result of the TMA III decision, effective immediately, the Departments have temporarily suspended all Federal IDR process operations until the Departments can provide additional instructions. Disputing parties should continue to engage in open negotiation.”
• The FEHBlog hopes that the federal regulators move to stay this decision pending appeal to the U.S. Court of Appeals for the Fifth Circuit. That court is already reviewing Judge Kernodle’s first decision modifying the final No Surprises Act implementing rule (No. 23-40217).

From Washington, DC —

• STAT News tells us,
  • “With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
  • “In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] detailed the various countermeasures available to combat COVID-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
  • “We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
  • “The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.”

• The CDC also updated flu vaccine information for the 2023-24 flu season.

• Per the U.S. Department of Justice,
  • “[On Wednesday, August 23, 2023,] Deputy Attorney General Lisa O. Monaco delivered opening remarks at a roundtable meeting of senior Justice Department officials and investigative partners to announce the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud. Deputy Attorney General Monaco also announced the launch of two additional COVID-19 Fraud Enforcement Strike Forces: one at the U.S. Attorney’s Office for the District of Colorado and one at the U.S. Attorney’s Office for the District of New Jersey. These two strike forces add to the three strike forces launched in September 2022 in the Eastern and Central Districts of California, the Southern District of Florida, and the District of Maryland.”

From the medical and Rx research fronts —

• BioPharma Dive reports,
  • “Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
  • “In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
  • “The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
  • “Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.”

• MedPage Today points out,
  • A novel 14-year risk score helped identify people from age 50 onward at risk for all-cause dementia, a large U.K. study showed.
  • The tool, called the U.K. Biobank Dementia Risk Score (UKBDRS), was developed and validated in two U.K. cohorts, reported Raihaan Patel, Ph.D., of the University of Oxford in England, and co-authors.

From the U.S. healthcare business front,

• Beckers Payer Issues relates,
  • Employers will pay more than $15,000 on average for each employee’s healthcare in 2024, according to an analysis from consulting firm Aon. 
  • Employer-sponsored insurance costs will rise 8.5 percent in 2024, up from an average of $13,906 per employee in 2023, according to Aon’s estimates published August 22.
  • Read the full report here.
• Fortunately, OPM’s decision to allow FEHB carriers to offer Medicare Part D EGWP arrangements in 2024 will offset the factors discussed in the Aon report.

• Beckers Hospital Review reports,
  • “Ongoing increases in expenses were part of the drive behind lower hospital operating margins in July, according to a Syntellis report.
  • “While such margins remained positive, they contracted for the first time since rising into the black in March, the report showed. The operating margin median for July was 1.1 percent compared to 2 percent in June, but still higher than the March through May period and 2.6 percentage points higher than July 2022.
  • “While overall expenses were up 3.6 percent on the same period in 2022, labor expenses increased 2.1 percent. Supplies and drug costs were both up over 5 percent, the report said.”

• Per Healthcare Dive,
  • “A new brief from out Wednesday from research firm KFF explores the potential of consumer cost changes and antitrust regulation when healthcare systems engage in cross-market mergers, including a body of research indicating possible healthcare price increases.
  • “Antitrust agencies have historically focused on mergers between hospitals and health systems that operate in the same geographic market, the KFF brief noted. The Federal Trade Commission has never formally challenged a cross-market merger and antitrust agencies have not developed guidelines for evaluating them.
  • “Regulating cross-market mergers, will be “on the radar” of policymakers and regulators as they become increasingly common, KFF said. Between 2010 and 2019, cross-market mergers made up 55% of hospital M&A ventures, and drove at least nine large-scale mergers since June 2021.”