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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Atrium Health sued for violating patient privacy, sharing data with Facebook and Google

In a court filing, the plaintiffs claim Atrium Health used Meta's Pixel code on its website, resulting in patients receiving targeted ads.

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Massive data trove from Change Healthcare hack now for sale on dark web

Cybercriminal group RansomHub claims to have protected health information from nearly every American.

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Change Healthcare faces second ransom as cybercriminals leak stolen data

A new hacker group is claiming credit for the data breach, first reported in February. Change Healthcare has already paid criminals a $22 million ransom.

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.

CMS proposed rule would boost Medicare inpatient rates by 2.6%

CMS has issued a proposed rule that would result in a net increase of 2.6% to the Medicare inpatient prospective payment system rate for fiscal year 2025, a raise that hospital trade groups say doesn’t go far enough.

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Payments to FDA advisory panel questioned

A recent investigation from KFF Health News about payments to members of an FDA panel evaluating an Abbott Laboratories cardiac device is raising eyebrows.

CMS drug price negotiations

Drug price dialogues represent ‘an opportunity for CMS to clarify negotiation policies and their potential impact for the future’

CMS must ensure transparency, clarity and predictability by providing detailed guidance on comparator drug selection and the evaluation of evidence, according to a group of D.C.-based health policy researchers.

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FDA announces recall of more than 300,000 catheter kits after 10 injuries, 1 death

This recall is due to reports of “increased resistance” when using the devices. There have been 194 customer complaints about the issue so far. 

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

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. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

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.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

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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