Rules and Regulations
"Tweener" hospitals eye financial relief after Supreme Court ruling
Editor's Note The Supreme Court’s recent “Chevron” ruling could offer additional financial security to hundreds of so-called "tweener" rural hospitals—those too large to be considered critical access hospitals but too small to be rural referral centers. Modern Healthcare reported the news July 29. According to the article, critical access hospitals,…
AAMI updates guidelines on radiation sterilization validation, single-use systems control
Editor's Note In a new guidance document for manufacturers of pharmaceuticals and biopharmaceuticals, The Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document updating best practices for radiation sterilization validation and routine control of single-use systems. The document, AAMI CR513:2024; Guidance on radiation sterilization validation and…
Physician survey illuminates negative impact of prior authorization
Editor's Note The American Medical Association (AMA) annual, nationwide prior authorization survey reveals that over 90% of physicians believe prior authorization negatively impacts patient clinical outcomes. “More telling,” AMA reported July 17, is the fact that 78% of physicians report that this process “sometimes or often” leads to patients abandoning…
Risks of animal-to-human disease jump remain high despite pandemic lessons
Editor's Note New findings highlight an urgent need to improve preventive measures against animal-borne diseases jumping to humans and potentially causing another global pandemic, US Today reported on July 21. The article details a study from Harvard Law School and New York University that examined animal-human interactions in 15 countries,…
FDA: Ventilator death, injury reports lower than initially reported
Editor's Note: Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…
FDA announces Class 1 recalls of ventilator, eye injection kits
Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…
Trump record, Republican National Convention hint at GOP healthcare policy priorities
Editor's Note As the Republican National Convention meets in Milwaukee to nominate Donald Trump, the party is not expected to unveil a detailed healthcare platform. However, a July 15 report in Modern Healthcare covers what plans and past records reveal about the potential direction of health policy under a GOP…
FDA announces Class 1 recalls for ventilator software, electrode pads
Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…
Hospitals, health groups criticize CMS pay proposals
Editor's Note Hospital groups are criticizing CMS' proposed 2.6% pay increase for 2025, deeming it insufficient for nonprofit hospitals with operating margins near or below zero, according to a July 11 article in Becker’s Hospital CFO Report. The American Hospital Association and America's Essential Hospitals argue the rise won't cover…
CMS releases proposed Medicare payment rates for outpatient, ASC services
Editor's Note On July 10, CMS proposed Medicare payment rates for hospital outpatient and ambulatory surgery center (ASC) services for 2025. Published annually, the Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule will have a 60-day comment period, which this year ends September 9 prior to…
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