Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Today, the Affordable Care Act (ACA) regulators issued ACA FAQ 68 and a related HHS fact sheet. This letter addresses ongoing preventive care coverage issues separate from the proposed ACA rule, also issued today along with an HHS fact sheet, to expand contraceptive coverage with no cost sharing to include the OTC contraceptive pill and more.  The proposed rule will be open for public comment for sixty days after publication in the Federal Register. Government actions like the proposed rule, in the FEHBlog’s opinion, are a principal cause of skyrocketing medical costs.
  • Govexec reports,
    • “More than 200,000 U.S. Postal Service employees will receive a nearly 5% pay raise over the next year if its largest letter carriers’ union agrees to the new contract its leaders have negotiated with agency management. 
    • “The employees will also have more opportunities for overtime and be able to reach the top slots of their pay scales more quickly, the National Association of Letter Carriers said of their new tentative agreement. The contract must still be approved by NALC members before it goes into effect. A failure to ratify the deal would likely result in arbitration. 
    • “The agreement would cover the period from May 2023 into November 2026, meaning the first two of the three scheduled 1.3% wage increases would apply retroactively. Employees would also receive a series of cost-of-living adjustments, the first three would also be paid retroactively and total around $2,300. 
    • “After almost 20 months of tireless negotiations, we are pleased to reach a fair agreement that rewards our members for their contributions to the Postal Service and their service to the American people,” NALC President Brian Renfroe said.” 
  • MedTech Dive informs us,
    • “Boston Scientific received Food and Drug Administration approval for Farawave Nav, a treatment for paroxysmal atrial fibrillation (AFib) that enables cardiac mapping and pulsed field ablation (PFA) therapy with a single integrated catheter.
    • “In tandem, the company gained 510(k) clearance for new software, called Faraview, to provide visualization for cardiac ablation procedures with its Farapulse PFA system, the medical device maker said Friday. Boston Scientific will immediately launch the Farawave Nav ablation catheter and Faraview software in the U.S. 
    • “In a race among medtech companies in the PFA space, Boston Scientific is now the first with mapping-integrated PFA, “a meaningful technology step-forward,” Stifel analyst Rick Wise said Sunday in a note to clients.”
  • and
    • “The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
    • “Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
    • “The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.”

From the public health and medical research front,

  • Health Day tells us,
    • “Walking pneumonia cases are surging among young children in the United States, federal health officials warn.
    • “Bacterial infections caused by Mycoplasma pneumoniae increased in the United States since late spring and have remained high,” a statement issued Friday by the U.S. Centers for Disease Control and Prevention noted. “The proportion of patients discharged from emergency departments with a diagnosis of M. pneumoniae-associated pneumonia or acute bronchitis has been increasing over the past six months, peaking in late August.”
    • “The worst rates of the illness have been seen in young children ages 2 to 4, according to the agency.
    • “The increase in children ages 2–4 years is notable because M. pneumoniae historically hasn’t been recognized as a leading cause of pneumonia in this age group,” the CDC added.”
  • NBC News informs us,
    • “Since 2000, breast cancer incidence among Asian American and Pacific Islander women under 50 years old has increased by 50%, more than 2% every year since 2012, according to a new report from the American Cancer Society.
    • “Asian American and Pacific Islander women in this age cohort had the second-lowest rate of breast cancer among all racial groups in 2000. They now have the highest rate alongside white women, about 86 per 100,000.
    • “Breast cancer is still more common the older we get, but it’s alarming to see younger women being diagnosed,” said Dr. Helen Chew, director of the clinical breast cancer program at UC Davis Health.
    • “Breast cancer has risen sharply among younger Asian American women in the past quarter-century due in part to acculturation and greater awareness around screenings, though experts say more research is required to determine exact causes for specific ethnic groups.
    • “Asian women like Huang have a higher prevalence of dense breasts, meaning there are more glands and tissue than fat, than women of other races, likely due to genetic factors and lower body mass indexes, experts say. And women with dense breasts are four times as likely to develop breast cancer as those with fatty breasts, an issue experts say needs more awareness.”
  • MedPage Today points out,
    • “The American Heart Association and the American Stroke Association updated guidelines for the primary prevention of stroke, emphasizing primary care screening, lifestyle management, and risk factor control.
    • “The guideline, published in Stroke, replaced the 2014 version to guide management for individuals with no prior history of stroke.
    • “This guideline is important because new discoveries have been made since the last update 10 years ago. Understanding which people are at increased risk of a first stroke and providing support to preserve heart and brain health can help prevent a first stroke,” said writing group chair Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, in a press release.
  • The Wall Street Journal relates,
    • “Novo Nordisk’s once-daily pill to treat type 2 diabetes has shown it cuts the risk of heart attacks and strokes in patients by up to 14%, according to a new trial.
    • “Rybelsus is an oral form of semaglutide, the active ingredient in the company’s blockbuster Ozempic and Wegovy diabetes and weight-loss drugs, and was tested in the trial on diabetic patients who also suffered from established cardiovascular disease and/or chronic kidney disease.
    • “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
    • “The company said the drug appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials and showed it reduces the risk of major cardiovascular events such as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
    • “Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the U.S. and European Union around the turn of the year.”
  • The American Medical Association lets us know what doctors wish their patients knew about childhood obesity.
  • Consumer Reports discusses urinary tract infections that afflict older folks.
  • The Institute for Clinical and Economic Review published a Final Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy.
    • An independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for tafamidis, acoramidis, and vutrisiran when compared to no disease-specific therapy; tafamidis and acoramidis would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Technology giant Amazon is partnering with a high-profile provider to expand its primary care offerings.
    • “Amazon One Medical will collaborate with Cleveland Clinic to open a primary care office in 2025, with plans for additional locations over the next few years, the organizations said Monday.
    • “We’re starting small with a couple of locations, … then we’ll see where it takes us,” said. Dr. Tomislav Mihaljevic, CEO and president at Cleveland Clinic. “We’re continuously evaluating potential partnerships, and this is the one that just rose to the top of what we think is the right thing for our patients.”
    • “Facilities will be staffed by One Medical clinicians. Although walk-in care will be publicly available, only One Medical members will be able to make appointments online or access telehealth, among other services.
    • “The affiliation will enable One Medical members to access specialty care at Cleveland Clinic via patient referrals, the organizations said.”
  • Per MedTech Dive,
    • “Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025.
    • “Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday. Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added.
    • “Da Vinci 5 installations are “well ahead of lofty buy-side expectations,” said BTIG analyst Ryan Zimmerman. “Limited launch or not, that’s a lot of [da Vinci 5] demand,” the analyst wrote in a note to clients after the call. BTIG estimated the number of cases completed with da Vinci 5 equals nearly 32 procedures per system per quarter.”