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 launches new pilot program to improve medical device development

The U.S. Food and Drug Administration (FDA) has launched a new pilot program that aims to streamline medical device development, increase predictability and reduce the time from concept to commercialization.

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Most consumers are not shopping around for better healthcare prices

While the Biden administration and federal agencies have made price transparency a long-term goal for the U.S. healthcare industry, a recent study revealed Americans aren’t actually shopping around very often for better healthcare prices.

Example of the four types of breast tissue density. The density of fibroglandular tissue inside the breast impacts the ability to easily see cancers. Cancers are very easy to spot in fatty breasts, but are almost impossible to find in extremely dense breasts. These examples show craniocaudal mammogram findings characterized as almost entirely fatty (far left), scattered areas of fibroglandular density (second from left), heterogeneously dense (second from right), and extremely dense (far right). RSNA

Breast density notification laws blanket 90% of U.S. women, yet still no national reporting standard is at hand. Why is that?

Dense breast experts Wendie Berg, MD, and JoAnn Pushkin, executive director of DenseBreast-info Inc., explain the current status of breast density patient inform laws, reimbursement and new technologies to aid cancer detection. 

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CMS aims to create centralized directory

According to the agency, directories can serve as important resources for patients who need to locate providers or compare health plan networks.

Dhanunjaya "DJ" Lakkireddy, MD, executive medical director for the Kansas City Heart Rhythm Institute at HCA Midwest Health, professor of medicine at the University of Missouri, Columbia, deputy editor for the the Journal of Atrial Fibrillation, and serves on the HRS Board of Trustees and section steering committee chair for the ACC, explains the potentially devastating impact of Medicare cuts on electrophysiology (EP) and patient care.

VIDEO: Medicare cuts could devastate the field of electrophysiology

"By imposing a 35%-42% cut, [CMS] has essentially created a scenario where it is going to destroy electrophysiology as a field," explained Dhanunjaya "DJ" Lakkireddy, MD.

Industry insights: 4 healthcare executives discuss the biggest challenges in cardiology today

We spoke to executives from some of healthcare's most prominent vendors to find out what challenges are on their radar in 2022 and beyond. 

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Healthcare groups ask DOJ for protection against violence over gender-affirming care

Three major healthcare groups are taking a stand against threats of violence over gender-affirming care by asking the Department of Justice to get involved. 

 

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AHA wins lawsuit over 340B payment cuts

The American Hospital Association (AHA) has claimed victory after the U.S. District Court for the District of Columbia ruled that the Department of Health and Human Services (HHS) must immediately halt payment cuts to the 340B Drug Pricing Program.

Around the web

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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