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. 

Newsweek ranked the 50 best heart hospitals in the world

10 key updates from new American College of Cardiology inpatient heart failure recommendations

The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.

Cardiologist Ami B. Bhatt, MD, a digital health specialist and longtime member of the American College of Cardiology (ACC), will serve as the Digital Health Advisory Committee's very first chair.

Cardiologist to chair new FDA advisory committee focused on AI, other digital health technologies

The Digital Health Advisory Committee is tasked with providing perspective and recommendations on a wide variety of topics. These insights will then help the FDA draft new policies and make other important decisions.

Dan Blumenthal, MD, MBA, chief quality officer at the Cardiovascular Associates of America, and a cardiologist at Massachusetts General Hospital, spoke at the Heart Rhythm Society (HRS) 2024 meeting business sessions on how changes in Medicare payments will impact electrophysiology and cardiology more broadly.

What cardiologists should expect as U.S. healthcare payment models evolve

Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 

doctor examines patient data on their tablet

FDA sees potential in new PET imaging agent for cardiac amyloidosis

Early evidence suggests a new PET imaging agent from California-based Attralus can help evaluate all varieties of systemic cardiac amyloidosis. It has now been granted the FDA's breakthrough therapy designation. 

CVRx Barostim illustration

CMS increases inpatient payment for implantable Barostim device

CVRx has now received improved outpatient and inpatient reimbursements for its implantable heart failure device in the last 12 months. The company's president says these updates will help more patients gain access to the Barostim technology. 

Bharath Krishnamurthy, a director of Health Policy and Analytics at the American Hospital Association (AHA), explains the financial impact of the growing healthcare staffing shortage.

Healthcare staffing shortages leading to financial instability

Bharath Krishnamurthy, a director of health policy and analytics at the American Hospital Association, explains the financial impact of current healthcare staffing shortages.

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Abbott says some FreeStyle Libre 3 sensors need replacement—patients should discontinue use

The new medical device correction only includes a select number of devices. Abbott said they produce inaccurate readings, putting patient health at risk. 

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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