Rules and Regulations

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November 2025
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Price transparency in surgical settings

Takeaways • Healthcare consumers are not aware that they can ask how much something costs. • There is disconnect between the law and common knowledge, and patients generally are confused about what they receive as good faith estimates. • In addition to incorrect CPT codes and OON allowable charges, the…

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By: Uyen Vo, BSN, MBA
July 20, 2023
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Keeping it sterile: Fundamentals of sterile storage

Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
July 20, 2023
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Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices

Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…

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By: Judy Mathias
July 18, 2023
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ACS: Outdoor safety tips from a pediatric trauma surgeon

Editor's Note With increased summer time outdoor activities is an increase in injury rates, which trauma surgeons often refer to as “trauma season,” according to a July 18 report from the American College of Surgeons (ACS). Brendan Campbell, MD, MPH, FACS, chair of the Injury Prevention and Control Committee of…

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By: Judy Mathias
July 18, 2023
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CMS proposes changes to price transparency rules, mental health services

Editor's Note On July 13, the Centers for Medicare & Medicaid Services (CMS) issued a proposal that would increase Medicare hospital outpatient prospective payment system rates by a net 2.8% in 2024 compared to 2023, including a “proposed 3% market basket update, offset by a 0.2% cut for productivity,” the…

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By: Tarsilla Moura
July 14, 2023
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The Joint Commission: PSC performance measure renamed

Editor's Note The Joint Commission, on July 5, announced that the Primary Stroke Center (PSC) Certification performance measure Stroke Volume (STK-VOL-1) is being renamed to Ischemic Stroke Patients who Receive Mechanical Endovascular Reperfusion Therapy, which removes the word “eligible” from the title. The change distinguishes ischemic stroke patients who receive…

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By: Judy Mathias
July 12, 2023
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The Joint Commission updates resources in Health Care Equity accreditation, certification resource centers

Editor's Note The Joint Commission, on July 5, announced that it had updated its Health Care Equity (HCE) Accreditation Standards & Resource Center and its HCE Certification Resource Center to help organizations meet healthcare equity requirements. New resources in the HCE Accreditation Standards & Resource Center include: the feasibility of…

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By: Judy Mathias
July 11, 2023
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AHA urges EPA to ensure proposed EtO standards don’t disrupt healthcare delivery

Editor's Note In a June 27 letter, the American Hospital Association (AHA) urged the Environmental Protection Agency (EPA) “to avoid disrupting healthcare delivery through the unintentional fracturing” of the medical device supply chain with its proposed ethylene oxide (EtO) standards. The EPA proposes: reducing EtO emissions by 80% adding new…

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By: Judy Mathias
June 29, 2023
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Compliance with CMS Hospital Price Transparency Rule linked to financial penalties

Editor's Note This study from Harvard Medical School, Boston, and Georgetown University, Washington, DC, finds that hospital compliance with the Centers for Medicare & Medicaid Services (CMS) 2021 Price Transparency Rule is increasing since financial penalties were enforced. Data from 4,377 acute care hospitals operating in 2021 and 2022 were…

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By: Judy Mathias
June 28, 2023
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The Joint Commission starts new voluntary Health Care Equity Certification

Editor's Note The Joint Commission, on June 27, announced that it is starting a new voluntary Health care Equity Certification Program, effective July 1. The advanced certification recognizes hospitals for excellence in their efforts to provide equitable care, treatment, and services and builds on longstanding accreditation requirements that support healthcare…

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By: Judy Mathias
June 28, 2023
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