FDA extends UDI compliance dates for Class I, unclassified devices
Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…
Joint Commission: Changes to post-survey processes, decision rules
Editor's Note The Joint Commission on February 22 announced that recent changes had been made to simplify and streamline the accreditation post-survey process and decision rules. Among the changes: An organization with an accredited with follow-up decision will receive full accreditation once it has successfully submitted evidence of standards compliance.…
Editorial
Even before Trump took office, Congress was planning to prepare ACA repeal legislation by January 27. It looked as though action could be swift once key members of the new administration took office. However, The Washington Post’s report of a January 26 meeting of Republican lawmakers indicated they were far…
CMS immediate jeopardy trail may lead to the OR
What makes an OR subject to an immediate jeopardy finding from a Medicare inspection? Immediate jeopardy is cited when a provider’s noncompliance with one or more of the Centers for Medicare & Medicaid’s (CMS) Conditions of Participation causes or is likely to cause serious injury, harm, impairment, or death. …
DNV accreditation: A positive spin on survey preparation
There is a lot of buzz in the healthcare community about a newcomer to the accreditation process. For many years, the Joint Commission was the first choice for providing accreditation for hospitals in the US. But Norway-based Det Norske Veritas (DNV) is gaining ground, representing more than 350 hospitals and…
Mass ASCs can offer more procedures without hospital affiliation
Editor's Note New Massachusetts (Mass) state regulations approved January 11 allow freestanding ambulatory surgery centers (ASCs) to apply for permission to expand or offer new lines of procedures without being affiliated with an acute care hospital, the January 19 Enterprise News reports. The new regulations lift a 20-year moratorium on…
CRNAs not included in new VA nurse practice rule
Editor's Note The Department of Veterans Affairs (VA) on December 13 issued a final rule allowing full practice authority for certain advanced practice registered nurses working in VA facilities, including certified nurse practitioners, clinical nurse specialists, and certified nurse midwives. The rule excludes certified registered nurse anesthetists (CRNAs), following lobbying…
ASCA lauds passage of 21st Century Cures Act
Editor's Note The Ambulatory Surgery Center Association (ASCA) on December 7 applauded Congress for passing the 21st Century Cures Act, which includes two provisions that benefit Medicare patients and physicians in ambulatory surgery centers (ASCs). The first provision, Section 4012, directs the Department of Health and Human Services (HHS) to…
Deadline for ASC nondiscrimination requirements is Oct 19
Editor's Note Ambulatory surgery centers (ASCs) must comply with nondiscrimination requirements in Section 1557 of the Affordable Care Act by October 19, the Ambulatory Surgery Center Association announced on September 28. The Act prohibits sex discrimination and requires language assistance for those with limited English proficiency and effective communication for…
FDA expands indication for two transcatheter aortic valves
Editor's Note The Food and Drug Administration (FDA) on August 18 approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic stenosis. The new indication is for patients who are at intermediate risk for death or complications associated with open-heart surgery. Previously,…
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