Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Product Recall

FDA announces another recall for troubled heart device after a patient death

This latest recall involves the device's batteries, which are separating due to a "welding defect." 

June 23, 2022
The ASNC is one of several medical imaging societies asking Congress to repeal the appropriate use criteria (AUC) criteria mandate. They say it poses issues for clinicians and is becoming outdated by changes in CMS payment systems. The AUC requirements call for documentation using CVMS authorized software in order to show advanced imaging such as nuclear and CT is justified, or else Medicare payments might be withheld.

VIDEO: AMA will ask Congress to revise clinical decision support mandate for cardiac imaging

American Society of Nuclear Cardiology (ASNC) delegates to the American Medical Association (AMA) House of Delegates 2022 meeting Stephen Bloom, MD, and Nishant Shah, MD, explain a new AMA policy asking Congress to revise its clinician decision support mandate. 

June 22, 2022
American Medical Association President Gerald Harmon, MD, explains some of the hottest topics discussed at the 2022 AMA House of Delegates meeting in Chicago. Harmon, a retired Air Force general and family practice specialist, said the top polices adopted where those that addressed gun control, physician burn out and issues regarding scope creep where non-physicians are filling roles traditionally held by doctors. #AMAmtg #AMA175 #AMA #guncontrol

VIDEO: AMA president discusses gun control, physician burnout and scope creep

American Medical Association President Gerald Harmon, MD, joined us for an exclusive chat about some of the hottest topics discussed at the 2022 AMA House of Delegates meeting.

June 16, 2022
contrast shortage

7 ways cath labs can work through the contrast media shortage without delays

When the ongoing contrast media shortage first started impacting health systems, one group in Ohio pledged not to delay a single procedure in its cath labs.

June 15, 2022
Medtronic is once again recalling its HeartWare Ventricular Assist Device (HVAD) pump implant kit, a part of the company’s HeartWare HVAD system. This is a Class I recall, which means using the device can lead to serious injury or death. The new recall includes more than 1,600 devices distributed from October 2006 to June 2021.

FDA announces another recall of Medtronic HVAD pump implant kits—1 patient death reported

The recall includes more than 1,600 devices distributed from October 2006 to June 2021. Medtronic's HVAD system has already been associated with multiple issues, including a separate recall in 2021. 

June 10, 2022
Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

FDA committee backs Novavax's COVID-19 vaccine despite heart damage concerns

The committee's approval comes days after the FDA shared details on a small number of trial participants who developed myocarditis or pericarditis after receiving the vaccine.  

June 9, 2022
Iodine contrast being loaded into a contrast injector in preparation for a cardiac CT scan at Duly Health and Care in Lisle, Illinois. The contrast shortage is causing some healthcare organizations to postpone exams and procedures and ration contrast supplies. Photo by Dave Fornell

ACR working with FDA and HHS to help address imaging contrast shortage

The American College of Radiology (ACR) announced this week its government relations staff has been engaging federal agencies in an effort to improve product availability and hasten resolution of the ongoing iodine contrast shortage.

May 26, 2022
Interview with Alan H. Matsumoto, MD, FSIR, FACR, FAHA, professor of radiology, chair of the Department of Radiology at the University of Virginia, vice chair of the American College of Radiology (ACR) Board of Chancellors, and the chairman of the ACR Commission on Interventional and Cardiovascular Radiology. He explains how the ACR and group purchasing organizations are asking the FDA to mitigate the contrast shortage with an emergency use authorization (EUA) to allow non-FDA cleared iodine contrast use.

VIDEO: American College of Radiology working with FDA to mitigate contrast shortage

Alan Matsumoto, MD, chair of the department of radiology at the University of Virginia and vice chair of the ACR Board of Chancellors, explains how the ACR and group purchasing organizations are asking the FDA to mitigate the contrast shortage with an emergency use authorization to allow non-FDA cleared iodine contrast agents to be imported.

May 26, 2022
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Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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