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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FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

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FDA announces recall of certain Impella heart pumps after 3 patient injuries, nearly 200 complaints

The FDA has labeled this as a Class I recall, which means using these devices can lead to significant injuries, including death.

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Nearing a ‘breaking point’: Cardiologists support legislation designed to mitigate Medicare cuts to office-based services

These latest cuts could be a "breaking point" for physicians, according to a new letter to lawmakers. 

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TAVR controversy: Surgeon fired after saying cardiologist treated patients without proper credentials

An Ohio doctor allegedly performed multiple procedures without the proper credentials. A vascular surgeon is now out of work for sharing the story with a local media outlet. 

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Cardiology groups issue statement on bullying, harassment and discrimination within the specialty

Bullying and other inappropriate workplace behaviors have been linked to an increased risk of errors and worse patient outcomes. 

Sam Jones, MD, explains why CMS reduced payments for EP ablation and how it will negatively impact electrophysiology. #HRS #HRS2023 #EPeeps #EPlab #Medicare

Making sense of the huge Medicare reimbursement cuts in electrophysiology

Samuel Jones, MD, examines the large reimbursement reductions in cardiac ablations and what the impact might be on access to care in EP labs.

11 leading cardiology societies collaborate on new AUC for chronic coronary disease

The new AUC document, which examines the treatment of both symptomatic and asymptomatic patients, was published in full in the Journal of the American College of Cardiology.

A figure from the HRS remote monitoring consensus document on staffing challenges with remote monitoring.

Electrophysiology experts issue recommendations for remote monitoring of CIEDs

The Heart Rhythm Society released a new expert consensus statement on the management of remote device clinics for implantable EP devices.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

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

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