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. 

2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.

Q&A: Interventional cardiologist details key breakthroughs in tricuspid valve replacement and repair

How have recent FDA approvals for Edwards Lifesciences and Abbott changed patient care? Andrew Rassi, MD, answered that question—and many more—in a new interview. 

April 18, 2024
the words "FDA recall" on a board

Boston Scientific recalls premixed embolic agent after two deaths

There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.  

April 17, 2024
Video interview with ACC President Cathie Biga on goals for college over the next year and trends she saw at ACC 2024.

New ACC President Cathie Biga wants to improve quality reporting in cardiology

Biga, who originally trained as a nurse, specializes in the business side of cardiology. She also emphasized the increasing importance of AI and other new technologies. 

April 17, 2024
pharmaceutical drug approval process

FDA grants fast track designation to new drug for Friedreich's ataxia cardiomyopathy

The new gene therapy candidate is now one step closer to being approved by the FDA. 

April 17, 2024
Abbott’s HeartMate 3 left ventricular assist device (LVAD) has been implanted in thousands of U.S. patients in recent years.According to a new investigative report from CBS News and KFF Health News, however, safety data related to the device have raised questions in certain parts of the healthcare industry.

FDA announces new recall of Abbott’s HeartMate LVADs after 14 deaths

The issue at the center of this recall, which includes both the HeartMate II and HeartMate 3 LVAD, is the gradual buildup of biological materials. This can impact the device's performance, creating a heightened risk of injury or death. 

April 15, 2024
Healthcare systems set up at the ACC.24 career fair in hopes of filling open positions, including a large and growing number of general cardiologist positions. Photo by Dave Fornell #ACC24 #ACC2024

The growing shortage or general cardiologists and recruiting crisis in rural America

There is a rapidly growing shortage in general cardiologists and for positions in rural areas, numerous healthcare system recruiters set up at the ACC reported.

April 12, 2024

Watchdog group calls out risks associated with private equity in cardiology, other specialties

U.S. Senator Elizabeth Warren, an outspoken critic of private equity's influence, praised the group's efforts. "Together, we’re taking on this trillion-dollar, behemoth industry that’s hurting working people and sucking money out of the rest of the economy," she said. 

April 9, 2024
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

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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