Regulations/Legal

Latest Issue of OR Manager
March 2025
Home Regulations/Legal

CMS halts COVID-19 testing in non-CLIA-certified labs

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on October 9 announced that it is taking action to stop labs that are testing for COVID-19 without proper Clinical Laboratory Improvements Amendments (CLIA) certification. The agency has issued 171 cease-and-desist letters to US facilities that were testing for COVID-19…

Read More

By: Judy Mathias
October 13, 2020
Share

CMS threatens to withhold payments from hospitals not reporting COVID-19, flu data

Editor's Note The Centers for Medicare and Medicaid Services (CMS) on October 6 released guidance on how it will implement an interim final rule that requires hospitals and critical access hospitals to report data on COVID-19 and flu patients. CMS says failure to report specified data may lead to termination…

Read More

By: Judy Mathias
October 8, 2020
Share

FDA issues guidance on EUA for COVID-19 vaccines

Editor's Note The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines. The recommended data and information include: chemistry, manufacturing, and controls information clinical and nonclinical data and information administration and…

Read More

By: Judy Mathias
October 8, 2020
Share

CDC updates guidance on how COVID-19 spreads

Editor's Note The Centers for Disease Control and Prevention (CDC), on October 5, issued updated guidance to its "How COVID-19 Spreads" website, which includes information on the potential for airborne spread of the virus. The CDC says that, based on current science, it continues to believe people are more likely…

Read More

By: Judy Mathias
October 7, 2020
Share

Sponsored Message

HHS renews public health emergency for COVID-19

Editor's Note Secretary of Health and Human Services (HHS), Alex Azar, on October 2, renewed the national public health emergency (PHE) for COVID-19 for another 90 days. The renewal will take effect October 23. This is the third renewal of PHE, which has been in effect since late January. The…

Read More

By: Judy Mathias
October 6, 2020
Share

FDA warns about hand sanitizers packaged in food, drink containers or containing methanol

Editor's Note The Food & Drug Administration (FDA) on August 27 (updated September 2) issued a warning about alcohol-based hand sanitizers packaged in containers that may appear as food or drinks and could put consumers at risk of serious injury or death if ingested.( https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers ) Some hand sanitizers are…

Read More

By: Judy Mathias
October 1, 2020
Share

Sponsored Message

Joint Commission revises EC standard for fluoroscopy services

Editor's Note The Joint Commission on September 30 announced a revision to its Environment of Care (EC) standard EC.02.04.03, element of performance (EP) 34, which will take effect January 1, 2021, for ambulatory care organizations, office based surgery practices, hospitals, and critical access hospitals. The Joint Commission has determined that…

Read More

By: Judy Mathias
October 1, 2020
Share

ASCs reduce Medicare costs $4 billion annually

Editor's Note A new analysis of Medicare payment data by KNG Health Consulting shows that ambulatory surgery centers (ASCs) reduced Medicare costs by $28.7 billion from 2011 to 2018, a savings of more than $4 billion each year. The analysis also shows that, without policy changes, performing procedures on Medicare…

Read More

By: Judy Mathias
September 29, 2020
Share

COVID-19 in healthcare workers

Editor's Note This meta-analysis by researchers in Switzerland and Columbia finds that healthcare workers (HCWs) exhibit a high prevalence of COVID-19 infection, with a significant proportion of them being asymptomatic carriers. This favors silent transmission in clinical and community settings. The meta-analysis comprised 97 studies published in 2020, and 230,398…

Read More

By: Judy Mathias
September 24, 2020
Share

Joint Commission seeks feedback on proposed requirements for spine surgery certification

Editor's Note The Joint Commission on September 23 announced that it is seeking feedback on proposed requirements for its Advanced Certification in Spine Surgery. In collaboration with the American Academy of Orthopaedic Surgeons, the Joint Commission developed the proposed spine surgery related requirements to include: program structure delivery of care…

Read More

By: Judy Mathias
September 24, 2020
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat