Tag: Rules and Regulations

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…

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By: Matt Danford
August 13, 2025
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5 costly mistakes to avoid when building an ASC

Editor's Note Poor planning and rushed decisions derail too many ambulatory surgery centers (ASCs) before they open their doors. In a recent blog post, ASC consultant Emily Spooner outlined the top five errors commonly made during ASC development, offering targeted guidance on how to avoid them. According to the post,…

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By: Tarsilla Moura
August 12, 2025
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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…

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By: Matt Danford
August 12, 2025
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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…

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By: Matt Danford
August 6, 2025
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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…

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By: Matt Danford
August 6, 2025
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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…

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By: Uyen Vo
August 6, 2025
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How ASCs ace the AAAHC accreditation survey: New handbook, delineation of privileges

Editor’s Note: This page is a companion piece to the main article, How ASCs ace the AAAHC accreditation survey. The posts below cover the latest version of the handbook from the Accreditation Association for Ambulatory Health Care (AAAHC) and advice on delineation of privileges.  Navigating the new handbook The latest…

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By: Uyen Vo
August 6, 2025
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Translating MIPS Value Pathways into perioperative practice—What OR leaders need to know

In July 2025, the Centers for Medicare & Medicaid Services (CMS) proposed sweeping changes to the Medicare Physician Fee Schedule for calendar year 2026. Among the most impactful updates is the launch of the Ambulatory Specialty Model (ASM)—a mandatory value-based payment program focused on heart failure and low back pain.…

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By: Tarsilla Moura
August 5, 2025
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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…

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By: Matt Danford
August 4, 2025
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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…

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By: Matt Danford
August 4, 2025
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