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. 

For almost nine years since the adoption of the Protecting Access to Medicare Act (PAMA) established the requirement for appropriate use criteria (AUC) to receive payment for advanced diagnostic imaging, the American Society of Nuclear Cardiology (ASNC) has lobbying Congressional leaders change or repeal AUC mandate. Those efforts have paid off in the 2024 Medicare Physician Fee Schedule final rule, where AUC program has been paused and all of its regulations were rescinded. Photo by Dave Fornell.

Medicare drops AUC requirement for advanced imaging, ASNC celebrates

"This was an unneeded burden, which was solely adding to the administrative hassles of medicine," said American Society of Nuclear Cardiology President Larry Phillips.

April 8, 2024
Product Recall

FDA announces new recall of neurovascular catheters built by Johnson & Johnson subsidiary

The recall is due to ongoing concerns about the devices breaking. Three patients have been injured as a result of this issue.

April 4, 2024
While a vast majority of heart transplants in the United States are successful, unplanned hospitalizations after the procedures are still incredibly common. Top 10 reasons for readmission after heart transplant.

On-pump vs. off-pump CABG: No difference in long-term mortality, meta-analysis confirms

Researchers explored data from nearly 70,000 patients, sharing their findings in the American Journal of Cardiology.

April 3, 2024
the words "FDA recall" on a board

FDA announces recall of more than 300,000 catheter kits after 10 injuries, 1 death

This recall is due to reports of “increased resistance” when using the devices. There have been 194 customer complaints about the issue so far. 

April 3, 2024
cardiologist patient heart compensation starting salary 2022 interventional cardiologist

Cardiology groups want to ‘transform the future of cardiovascular medicine’ with new medical board

Leaders from the American Heart Association, American College of CardiologyHeart Failure Society of AmericaHeart Rhythm Society and Society for Cardiovascular Angiography & Interventions have shared their vision for a new, independent Board of Cardiovascular Medicine.

April 2, 2024
Abbott has received approval from the U.S. Food and Drug Administration (FDA) for its TriClip transcatheter edge-to-edge repair (TEER) system designed to treat tricuspid regurgitation (TR).

FDA approves Abbott’s TriClip TEER device for tricuspid regurgitation

Less than two months after an FDA advisory panel voted in favor of approval, the transcatheter edge-to-edge repair system can now be sold and marketed in the United States.

April 2, 2024
physician money payments dollars

Cardiologists received $1.3B in industry payments over 10-year period, No. 3 among all healthcare specialties

Only orthopedic surgeons and neurologists/psychiatrists received more industry payments from 2013 to 2022 than cardiologists. Also, the two prescription medications associated with the most physician payments were a blood thinner and an anticoagulant. 

March 28, 2024
Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

FDA approves Medtronic’s next-generation TAVR system with new frame design

The Evolut FX+ TAVR system includes an updated diamond-shaped frame, which was made four times larger than previous models to offer improved coronary access. It was also designed to provide more space for operators to guide and maneuver the catheter during procedures.

March 28, 2024

Around the web

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

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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