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. 

Cardiologists applaud new research on social/structural determinants of health among heart patients

The American Heart Association and Association of Black Cardiologists announced the winners of a six-month data challenge, describing health equity as "one of the most pressing areas in healthcare.”

July 15, 2022
Doctor patient

Proposed Medicare Physician Free Schedule would decrease cardiology payments, ACC calls it ‘the continuation of a troubling trend’

CMS also announced that the penalty phase of its Appropriate Use Criteria Program has been delayed yet again.

July 11, 2022

Could an effective breast cancer therapy be bad for the heart? NIH awards $3.1M to find out

Researchers will examine stress test results, CT images, and blood tests for women who undergo estrogen depletion as a treatment for breast cancer.

July 8, 2022
American Society of Echocardiography (ASE) past president Jonathan Lindner, MD, FASE, is a newly named advisor to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which advises the Centers for Medicare and Medicaid Services (CMS) on whether services and supplies are reasonable and necessary under Medicare.

Cardiologist Jonathan Lindner to advise influential Medicare committee

As a MEDCAC advisor, American Society of Echocardiography past president Jonathan Lindner, MD, will help decide whether services and supplies are reasonable and necessary under Medicare.

July 6, 2022
The most successful case to date of a pig organ being transplanted into a human occurred back in January, when specialists at the University of Maryland Medical Center (UMMC) in Baltimore transplanted a modified pig heart into 57-year-old David Bennett. The FDA approved the heart transplant transplant through an emergency authorization typically reserved for experimental procedures seen as a patient’s last chance at survival. Bennett did die of heart failure two months later.#pigheart

FDA may allow clinical trials of pig organ transplants into human patients

The FDA would approve trials on a case-by-case basis, according to an anonymous source close to the situation. 

July 1, 2022

Judge says Apple violated ECG patents, making U.S. import ban of Apple Watches a possibility

A judge from the U.S. International Trade Commission has said Apple violated multiple AliveCor patents. This story, however, is far from over.

June 30, 2022
When Apple previewed its watchOS 9 update in early June, one of the key features the company highlighted was a new tracking option for atrial fibrillation (AFib) patients. The AFib History feature, approved for patients 22 years and older who have been diagnosed with AFib, was designed to help users gain a better understanding of their symptoms and easily share data with healthcare providers.

Regulatory Roundup: FDA clears several new solutions, including Apple’s latest AFib offering

The FDA had a busy June, clearing multiple solutions designed to treat patients with cardiovascular conditions. 

June 27, 2022
The Society for Cardiovascular Angiography and Interventions (SCAI) has responded to the U.S. Food and Drug Administration’s (FDA’s) recommendation that all infants and young children who receive iodinated contrast media (ICM) undergo thyroid testing. The group pushed back against this proposal, emphasizing that implementation would have “far-reaching consequences.”

Cardiologists push back on FDA’s thyroid monitoring/contrast media proposal

According to a new SCAI statement, the FDA's recommendation would result in "far-reaching consequences" across multiple specialties. 

June 24, 2022

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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