Rules and Regulations

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February 2025
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FDA announces Class 1 recall for ventilator system

Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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By: Matt Danford
February 6, 2025
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Moody’s downgrades health insurance outlook as medical costs surge

Editor's Note Moody’s Ratings has shifted the health insurance industry’s credit outlook from stable to negative, according to a February 3 article in Fierce Healthcare. According to the article, the downgrade is due to escalating medical costs that outpace reimbursement rates. Analysts project an 8% rise in commercial market spending…

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By: Matt Danford
February 5, 2025
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FDA approves new non-opioid analgesic

Editor's Note The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. According to the agency’s January 30 announcement, the drug targets sodium channels in the peripheral nervous system to block pain signals before they reach the brain, representing…

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By: Matt Danford
February 5, 2025
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FDA announces multiple Class 1 recalls

Editor's Note The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These…

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By: Matt Danford
February 3, 2025
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Three strategies for demystifying the ASC supply chain puzzle

Ensuring safe, quality care requires precise alignment among inventory levels, delivery schedules, storage solutions, and every other element of the supply chain. A single missing piece of this puzzle—say, a delayed shipment or a storage issue—can disrupt the entire picture. Making the pieces fit can be difficult for any healthcare…

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By: Brad Clark and Jeff Kremer
January 31, 2025
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Proposed HIPAA updates would improve cybersecurity, increase costs for healthcare providers

Editor’s Note Entities covered by the HIPAA security rule may soon need to adapt to more prescriptive requirements, new compliance mandates, and significantly higher costs, according to a January 24 report from TechTarget. As outlined in a December notice of proposed rulemaking (NPRM), the proposal by the Department of Health…

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By: Matt Danford
January 30, 2025
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VA exempts over 300,000 healthcare jobs from federal hiring freeze

Editor's Note More than 300,000 healthcare positions within the Department of Veterans Affairs (VA) have been exempted from a federal hiring freeze ordered by President Donald Trump on January 20, ensuring continuity in care for veterans. Military.com reported the news January 23. According to the article, acting VA Secretary Todd…

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By: Matt Danford
January 24, 2025
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Providers push back on insurance cost-cutting hurdles

Editor's Note Escalating administrative hurdles from insurers are heightening tensions between healthcare payers and providers who criticize the measures for threatening patient care, Modern Healthcare reported January 22. According to the article, policies attracting criticism include stringent prior authorization rules, claims denials, and new fees for appeals. For their part,…

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By: Matt Danford
January 23, 2025
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HHS report highlights cost, access, quality concerns with private equity in healthcare

Editor's Note Growing consolidation and private equity investments in healthcare are driving up costs, reducing access, and raising quality concerns, according to a new report from the Department of Health and Human Services (HHS). According to HHS’ January 15 announcement, the report stems from a tri-agency effort by HHS, the…

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By: Matt Danford
January 17, 2025
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The Joint Commission issues new workplace violence prevention standards

Editor's Note New and revised workplace violence prevention requirements take effect for The Joint Commission-accredited, office-based surgery practices July 1, The Joint Commission announced.  According to the January 16 announcement, which also announced new and revised standards for accredited assisted living communities and nursing care centers, the updates aim to…

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By: Matt Danford
January 16, 2025
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