FDA announces Class 1 recall for Draeger breathing filters
Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
Healthcare providers express cash flow concerns under new 340B rebate model
Editor's Note Healthcare providers could experience significant cash flow and operational changes under a new voluntary pilot program that fundamentally alters how the nation's second-largest drug payment program operates, according to an August 11 article in Modern Healthcare. As detailed in the article, The Health Resources and Services Administration announced…
FDA orders opioid label changes to highlight long-term risks
Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…
Study: Loophole enables urban hospitals to qualify for rural subsidies
Editor's Note Hundreds of urban hospitals have obtained dual urban-rural Medicare classifications since a 2016 policy change, enabling them to qualify for reimbursement programs intended for rural providers. Fierce Healthcare reported the news August 4. As detailed in the article, a study published in Health Affairs by Johns Hopkins and…
How ASCs ace the AAAHC accreditation survey
For an ambulatory surgery center (ASC), earning accreditation can be more than a mark of excellence. The Accreditation Association for Ambulatory Health Care (AAAHC) offers Medicare Deemed Status Accreditation, eliminating the need for separate surveys to certify compliance with the Conditions of Participation (CoPs) required by the Centers for Medicare…
Nearly half of hospital patient harm events go unreported, OIG reveals
Editor's Note Nearly half of hospital harm events—particularly surgical events—were not captured by reporting systems, according to a July 30 TechTarget report on new findings from the Office of Inspector General (OIG). The OIG report examined 299 harm events experienced by a nationally representative sample of 770 Medicare patients discharged…
CMS’s newly finalized TEAM payment model holds hospitals accountable for entire surgical episodes
Editor's Note As part of the Centers for Medicare and Medicaid Services (CMS) newly issued 2026 Final Rule, the Transforming Episode Accountability Model (TEAM) will hold hospitals and health systems accountable for the entire episode of care for major surgeries, from admission through 30 days post-discharge. HIT Consultant reported the…
Judge orders restoration of deleted federal health data
Editor's Note A federal judge has ordered the Trump administration to restore health-related webpages and datasets removed under a January executive order, according to a July 29 article in Medscape. The ruling follows a lawsuit by Doctors for America and the city and county of San Francisco, which argued that…
Joint Commission to tailor accreditation standards for children’s hospitals
Editor's Note The Joint Commission has launched a new strategy to revise its accreditation and certification programs to better reflect the distinct needs of pediatric care. According to a July 29 announcement, the effort responds to requests from the children’s health community and aims to revise or remove standards that…
FDA designates Class I recall for disposable surgical stapler cartridge correction
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
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